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By Darin Detwiler, Gillian Kelleher and Roger Hancock

The goal of a food recall is simple: to remove compromised food in order to prevent people from eating contaminated food that could kill or sicken them. But if people don’t know about the recall, that goal cannot be achieved. If they hear about the recall after eating the food, the goal cannot be achieved. If they don’t trust, understand, or recognize the importance of the recall information, again, the goal cannot be achieved. 

To save lives and minimize health risks, we need clear, credible, and compelling recall information that is disseminated quickly and widely, not just to businesses across the supply chain, but also to consumers.  

The good news is that we know what to do and how to do it. We have the tools, the templates, and the technology to succeed. What we need is a shared and vigorous commitment on the part of the FDA, the USDA, the states, and the industry to modernize recalls today.

3 Steps the government should take

Both the FDA and the USDA have expressed interest in modernizing recalls.  Here’s how they can move from rhetoric to action:

  1. Both the FDA and the USDA should write and post all Class 1 food recalls. Today, this is standard practice for the USDA: it writes the recall announcement, gives the recalling firm a short period to review it, and then disseminates the announcement. The USDA uses templates to standardize and expedite the process. The messaging is concise to prevent confusion and promote action. The FDA needs to adopt this same practice. 
  2. The FDA needs to modernize its IT systems to facilitate and streamline industry reporting of recalls. For example, it could finalize seamless connectivity with the Reportable Food Registry (RFR) database for faster reporting. 
  3. Government agencies need to reach a consensus on the specific information that should be part of recall communications and eliminate extraneous information that does not help consumers recognize the products involved and motivate them to take action. 

 3 Steps the industry should take

  1. Companies need to disseminate recall information through channels commonly used to promote their products. While loyalty programs, social media, and websites are effective in reaching consumers, we see little evidence that these same tools are used to distribute recall information.
  2. With the goal of ensuring consistency and clarity in the provision and dissemination of recall information, the industry must agree upon a unified set of data elements and protocols. This will make information exchange faster and more reliable, providing all stakeholders with accurate and uniform data. 
  3. The industry needs to promote the use of modernized recall simulations that replicate real-world scenarios, going beyond traditional “mock recalls” that serve primarily as trace-back exercises. This allows stakeholders to practice and refine their response strategies in the context of their supply chains. 

What’s already being done in this space

In addition to the work being done by regulators and individual companies, other organizations are leading the charge to standardize and optimize the recall process, including consumer communication. 

  1. STOP Foodborne Illness, through its workgroup on recall modernization, is conducting crucial research to identify needed improvements in consumer messaging. Led by Dr. William Hallman, Distinguished Professor at Rutgers University and former chair of FDA’s Risk Communication Advisory Committee, STOP is developing and testing new food recall templates to determine those that will best inform and motivate consumers. In addition, STOP is emphasizing the need for the FDA to create a transparent set of recall classification decision criteria and to classify recalls in real time, something USDA already does.
  2. The Association of Food and Drug Officials (AFDO) has issued a white paper, Recall Modernization: Accelerated Partnering for Effective Recalls, urging the FDA to develop a concise recall handbook, standardize a process for classifying recalls, and work more closely with industry for effective recalls.
  3. The Alliance for Recall Ready Communities (ARRC), is a newly formed alliance that the three of us co-chair. We are bringing together organizations such as the International Fresh Produce Association, the American Frozen Food Institute, the Consumer Brands Association, the National Restaurant Association, and more, to establish and enable companies to use agreed-upon data standards, collaborative processes, powerful tech solutions, and recall simulations to quickly and effectively practice and manage food recalls. 

The steps outlined above are concrete and actionable. We encourage the FDA, the USDA, and industry to build on the work that’s begun. Together we can achieve the goal of reducing death and illness connected to contaminated food.  

About the authors:

Darin Detwiler, founder and president of Detwiler Consulting Group, LLC, is the director of the MS in Regulatory Affairs of Food and Food Industry and Professor of Food Policy at Northeastern University in Boston. In addition to serving as the chair of the National Environmental Health Association’s Food Safety Program Committee, Detwiler serves on numerous editorial and advisory panels related to food safety, sustainable development, leadership, and policy. He is a sought-after speaker on key issues in food policy at corporate and regulatory training events, as well as national and international events. Detwiler holds a doctorate of Law and Policy.

Gillian Kelleher is a food safety and quality leader with a four-decade career in the food industry, spanning multiple countries and sectors. She has worked with leading companies such as Häagen Dazs, Burger King, Express Foods, Pillsbury, and spent over twenty years at Wegmans Food Markets. As CEO and President of Kelleher Consultants LLC, Gillian helps companies build sustainable food safety and quality programs with a focus on prevention. She is a member of IAFP, IFT, and ASQ, and has served in various leadership roles, including vice chair of the Global Food Safety Initiative Board. Gillian is board co-chair of Stop Foodborne Illness. She also chairs the Educational Advisory Board for the Food Safety Summit and leads the Leafy Greens Safety Coalition.

Roger Hancock, CEO of Recall InfoLink is one of the world’s foremost experts on recalls, with experience that spans retail, tech, data, regulatory, and the entire supply chain. Prior to founding Recall InfoLink, he spent 15 years at Albertsons where he oversaw 250+ recalls every year, experiencing first-hand the pain points and need for better recall practices. 

The documentary “Poisoned: The Dirty Truth About Your Food” has been nominated for an Emmy in the Outstanding Current Affairs Documentary category. This recognition highlights the impact of the film, which made its debut on Netflix on Aug. 2, 2023, and sheds light on critical issues surrounding food safety in the United States.

Based on the bestselling book “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat” by Jeff Benedict, the documentary offers a gripping exposé that resonates with consumers, the food industry, regulators, and politicians. The film’s nomination underscores its relevance and the urgency of its message about the dangers posed by foodborne illnesses.

Directed by Stephanie Soechtig, known for her impactful works such as “Under the Gun” and “Fed Up,” “Poisoned” delves into the 1993 Jack in the Box E. coli outbreak, which was a pivotal moment in American food safety history. The outbreak, which resulted in numerous illnesses and deaths, spurred significant changes in food safety regulations and practices.

The film also spotlights outbreaks traced to leafy greens and includes interviews with victims of those outbreaks.

The documentary features prominent figures in food safety, including former government officials, industry spokespeople and Bill Marler, a food safety lawyer and publisher of Food Safety News. Marler played a crucial role in advocating for food safety reforms following the Jack in the Box incident. The film also includes testimonies from individuals personally affected by foodborne illnesses, such as Darin Detwiler, who lost his 16-month-old son Riley to E. coli during the outbreak.

“Poisoned” premiered at the Tribeca Film Festival in June 2023, where it garnered significant attention and acclaim.

The documentary’s Emmy nomination places it alongside other notable works in the Outstanding Current Affairs Documentary category, including:

  • “Loudmouth” (BET)
  • “Love in the Time of Fentanyl” (PBS)
  • “Mourning In Lod” (Showtime)
  • “No Accident” (HBO | Max)

A full list of Emmy nominations can be viewed here.

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— OPINION —

In the landscape of food safety, the 2011 Food Safety Modernization Act (FSMA) represents a monumental shift towards preventing contamination rather than merely responding to it. A new element of FSMA is the Food Traceability Final Rule (FSMA 204), which is designed to enhance the ability to track and trace food through the supply chain, with a compliance date of January 2026. 

Food traceability is not a new concept; it has been a fundamental aspect of food safety practices globally. The ability to trace food items through the entire supply chain — from farm to table—allows for rapid identification and containment of foodborne illness outbreaks. FSMA 204 is a critical part of this framework, and its successful implementation is paramount for public health.

However, recent legislative efforts threaten to undermine these advancements, potentially compromising the safety of our food supply. The Safe Food Coalition, comprising key food industry stakeholders and consumer protection organizations, has sounded the alarm over two bills in Congress aimed at weakening FSMA 204. These bills, if passed, would significantly dilute the FDA’s ability to trace and manage foodborne illness outbreaks.

House Resolution (HR) 7563 – “The Food Traceability Enhancement Act” proposes to ease recordkeeping and traceability lot code (TLC) requirements for restaurants, retail food establishments, and warehouses. It removes the mandate to maintain and provide TLC information to supply chain partners or the Secretary of Health and Human Services.  Further, this bill mandates at least nine pilot projects to measure the efficacy of foodborne illness outbreak investigations conducted without TLC information and to identify low-cost food traceability technologies.

The Fiscal Year (FY) 2025 Agriculture Appropriations Bill seeks to delay the FDA’s 2026 implementation date by requiring additional traceability pilots, including one that mandates solving outbreaks without lot code information. This bill provides no new funding for these pilots and effectively maintains funding at FY 2024 levels.

The Safe Food Coalition argues that the Food Traceability Final Rule aligns with best industry practices. As the 2026 compliance date approaches, many companies have made significant progress in tracking and recording data for food traceability, demonstrating the feasibility of compliance. Exempting lot code information, as proposed, would “effectively gut” the rule, allowing retailers to discard critical information that is essential for tracing and solving foodborne illness outbreaks.

Historical Lessons 

The current legislative efforts are reminiscent of past attempts to delay or weaken food safety regulations. Two notable examples illustrate the dangers of such actions:

Leafy Greens and FSMA water standards

In September 2107, the FDA decided to delay the implementation of the FSMA’s agricultural water standards (originally set to roll out between 2018 and 2022) to address stakeholder concerns regarding the feasibility and practicality of the standards. delayed the implementation of FSMA agricultural water standards.  

The delay in implementing these standards had dire public health consequences, as subsequent outbreaks highlighted the critical need for these standards. 

Between 2016 and 2024, numerous multi-state outbreaks (mostly E.coli O157, but also Cyclospora and Listeria) have been investigated each year.  The CDC identified hundreds of illnesses and hospitalizations, and at least five fatalities. These outbreaks included recalls of romaine lettuce and spinach, as well as several packaged salad products (Dole, Fresh Express).  Many notable outbreaks came with CDC and FDA warnings to avoid all romaine lettuce from the Yuma growing region or from areas in California, or recommendations that consumers avoid all romaine lettuce temporarily.

In its May 21, 2020 Report on their Investigation into Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce, the FDA focused not on their delay, but stated that their “ability to determine the source of contaminated foods that may have caused the illnesses has lagged, due in part to the lack of modernized food traceability capabilities.”

The USDA’s “Safe Handling” labels

In 1994, in response to the landmark 1993 E.coli outbreak, the USDA not only declared E.coli O157:H7 an illegal adulterant in meat and poultry under the USDA’s regulatory authority and initiated a “zero tolerance” policy for the pathogen, but also took another controversial step by requiring meat manufacturers to affix all packages of not-ready-to-eat meat and poultry at retail a label outlining safe-handling instructions. The goal was to ensure that the public understood not only how to handle raw meat and poultry products safely, but also how to properly cook it.

The USDA’s intention for mandating their food safe handling instruction labels on all packages of raw meat, and poultry products was to inform consumers how to protect themselves. The meat industry took a position against this mandate as the labels may result in shoppers’ knowledge that problems may exist. This warning indicated that more detailed information can be put out in a simple, precise way that would not require different labels for many products.

Concerns over consumer’s awareness about their meat’s safety was evident some 20 years earlier when the APHA sued the USDA on the grounds that their mark of inspection was misleading in APHA vs. Butz (1974). Claiming that consumers were not aware that the USDA’s stamp of approval on a piece of mead did not actually mean that they tested it for bacteria that posed a risk to public health, the APHA argued that the USDA should require that meat carry a warning label with handling and cooking instructions to protect the consumer from foodborne pathogens. The court decided in favor of the USDA and denied a rehearing in 1975.

In May of 1993 the government changed its position when it agreed to require the food safe handling labels as part of its settlement of a lawsuit filed in Washington, DC’s US District Court by Jeremy Rifkin from the consumer coalition “Beyond Beef.” Rifkin criticized the USDA on how the information on the labels was insufficient, thus creating a weak message. His group even demanded that “cook thoroughly” be replaced with more explicit instructions.

On Oct. 14, 1993, one day before the initial rule of the labeling was to take effect, the National American Wholesale Grocers Association convinced a Texas federal judge to issue an injunction to delay the labeling because “unlabeled meat was not a significant health threat, and that the tainted meat outbreak in January was isolated to the Pacific Northwest.” Only two weeks later, the Texas State Department of Health issued a statewide warning similar to the one contained in the USDA’s intended food safe handling labels because of the deaths of two 3-year-old Texas boys from E. coli.

Despite industry opposition, the labels were eventually implemented as of July 6, 1994, (a delay of three months from the USDA’s initially intended date), helping to educate consumers about proper food handling and cooking techniques. However, delays and compromises in the labeling process meant that critical information was not immediately available to the public, potentially exposing consumers to foodborne illnesses.

Conclusion

FSMA 204 represents years of progress in enhancing food safety standards. Many companies have already invested in systems to comply with these requirements, recognizing the critical role of traceability in protecting public health. The current legislative proposals to ease traceability requirements and delay the implementation of the Food Traceability Final Rule pose significant risks to public health. Without stringent traceability requirements, the FDA’s ability to quickly identify and contain foodborne illness outbreaks will be severely compromised. Rolling back these regulations would not only negate these efforts but also place consumers at greater risk of foodborne illnesses.

Delaying or weakening regulations can have serious public health implications. The proposed legislative changes to the Food Traceability Final Rule undermine the very foundation of food safety that the FSMA aims to strengthen. The American consumer gains no stronger food safety protections as a result of these delays. Recognizing that 3,000 American consumers die every year due to failures in food safety underscores the importance of robust food safety regulations. 

Congress must uphold the integrity of the Food Traceability Final Rule, ensuring that the FDA has the tools needed to protect consumers from foodborne illnesses. The safety of our food supply depends on a courageous commitment to rigorous standards and prompt action in the face of threats. For the sake of public health, efforts to weaken the safeguards that keep our food safe must be resisted.

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The recent Supreme Court decision to eliminate Chevron deference marks a pivotal shift in how federal agencies interpret and enforce laws. Established in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. (1984), Chevron deference allowed courts to defer to Executive Branch agencies’ interpretations of ambiguous statutes. This principle provided crucial regulatory oversight in sectors like food safety, ensuring clarity and expertise in enforcement.

Originating from environmental regulations, Chevron deference extended to empower other agencies – and this impacted the FDA and USDA in defining and implementing food safety standards. Over decades, it facilitated streamlined regulatory processes, enabling swift adaptation to emerging threats such as foodborne illnesses and novel food technologies. This doctrine supported rapid responses by interpreting laws to enforce safety protocols, coordinate stakeholder efforts, and protect public health during outbreaks.

On June 28, 2024, the US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerceoverturned Chevron deference, ushering in heightened judicial scrutiny over agency interpretations of laws. This decision removes automatic deference previously afforded to agencies like the FDA, necessitating rigorous justification of regulatory actions in court.

Examples from USDA 

Improved Regulatory Standards, Preventive Measures (such as HACCP) and Consumer Education and Safe Handling Practices are often cited as key reasons for the decrease in E. coli Outbreaks tied to USDA-regulated foods.

The USDA’s 1994 declaration of E. coli as an illegal adulterant in ground beef exemplifies the impact of Chevron deference. This regulatory action followed the landmark 1993 Jack in the Box E. coli outbreak, enhancing food safety by swiftly addressing risks associated with contaminated beef. Without Chevron deference, increased legal challenges and prolonged regulatory processes could have delayed these crucial measures, potentially jeopardizing consumer safety.

Similarly, USDA-mandated safe handling instructions for raw meat and poultry educate consumers on proper practices, crucial for preventing foodborne illnesses. For about 30 years, these instructions have played a crucial role in preventing foodborne illnesses caused by pathogens like E. coli and Salmonella, which can lead to severe health risks. These instructions, implemented a year after the 1993 Jack in the Box E. coli outbreak, benefited from Chevron deference in ensuring swift enforcement and clarity amidst potential legal challenges. If Chevron deference were not in place, the USDA’s ability to mandate and enforce labeling requirements might have been hindered by the same reasons, ultimately the implementation of crucial food safety measures aimed at protecting consumers from foodborne illnesses.  

Examples from FDA 

Chevron deference also facilitated FDA’s adaptation of labeling requirements to reflect scientific advancements, such as allergen labeling for major food allergens. This flexibility supported consistent implementation and consumer protection, which could face uncertainty without deference.

The passage of the Food Safety Modernization Act (FSMA) in 2011 marked a significant milestone in bolstering food safety standards and empowering the FDA. However, the absence of Chevron deference complicates ongoing FSMA implementation efforts, notably the Food Traceability Final Rule (FSMA Section 204(d)), crucial for the FDA’s New Era of Smarter Food Safety Blueprint. This could lead to legal challenges, regulatory uncertainties, and delays in enforcing robust food safety standards, potentially compromising public health responses to outbreaks and contaminants.

Moving Forward

In the wake of the Supreme Court’s decision to end Chevron deference, federal food agencies face a critical juncture. They must now bolster their regulatory justifications, enhance transparency in rulemaking, and urgently seek legislative clarity to navigate this evolving landscape effectively. Industry leaders, too, must rise to the occasion by not merely complying with regulations but by proactively implementing safety measures that safeguard public health and uphold the integrity of our food systems.

Consumers play a pivotal role in this new era by staying informed about food safety practices and advocating for transparent industry standards. Together, we can cultivate a culture of accountability and innovation that places food safety at the forefront, both domestically and globally.

Recalls and outbreaks exact a heavy toll, both in economic terms and, more significantly, in human lives. The wheels of justice move at a speed much slower than that which proper food safety proactive and reactive response demands. Even without Chevron deference, it is imperative that we prioritize efforts to uphold and strengthen the robust food safety culture cultivated after 1993. We must ensure that the progress achieved over the past three decades is not eroded by the challenges and decisions of the next 30 years.  

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Co-author Tyler Williams, Director of Scientific Services, PathoSans

— OPINION —

Each of the authors of this article serves a specific role for our respective organizations. But we are united by a belief in the importance of food safety as a critical public and personal health issue that impacts everyone. It’s an issue that can, without warning, make otherwise healthy people sick or even die – some of them young children. Yet, despite growing risks in the increasingly complex worldwide food industry, it’s an issue that is still too often rooted in a culture of ignorance and pass-the-buck thinking. 

Food safety is a major global health problem. In the U.S. alone, we claim to have one of the safest food supplies in the world. Yet each year, according to the USDA, 48 million get sick, 128,000 are hospitalized, and 3,000 die from foodborne illnesses. One of the authors of this article personally experienced the death of a child from an E. coli outbreak. So, we know just how real the risk is. We believe that It needs to be addressed by making it more than just “someone’s job;” it needs to be everyone’s mission.

Education and public policy
Often, when a serious food safety incident occurs, it’s publicized by local and national media, and sometimes it goes viral on social media. But frequently, people become ill in a way that doesn’t attract attention. Sometimes, they aren’t even fully aware what made them ill; food-related illnesses can be mistaken as the flu or some other undiagnosed illness. 

Unlike many other common consumer products, food – despite being consumed daily by every human – often does not have enough consumer and worker education. For example, a common and simple step ladder has safety warnings printed on its side. But have you ever seen a safety warning inserted into a package of ground beef about cooking it properly? Is the public aware that sometimes restaurants fail food inspections by their municipalities, yet are allowed to remain open? Do children receive food safety education as part of their curriculum? Most often, the answer to all these questions is no.

The worldwide business of food is a complex undertaking, with separate industries for growing, processing, manufacturing, and consumption. So, it’s a monumental task to tackle food safety at every conceivable touchpoint. The task is starting to be addressed by such efforts as the Global Food Safety Initiative, as well as many national organizations in the United States and other countries.

During the past thirty years, we have learned enough about food safety to raise awareness of the problem. For example, many cleaning chemicals now have labels boasting such information as “effective in killing E. coli bacteria,” which can be deadly. Many new food safety policies have been implemented at the federal, state and local levels. Educational institutions such as Northeastern University have expanded their curricula with education in food safety and regulatory policy. Consulting businesses such as Detwiler Consulting Group have arisen, dedicated to helping food businesses elevate their safety practices. We have worked with public policy makers to guide them on improvements to regulatory standards for safe food practices. And, we have also worked to raise awareness about our “food culture” as something that impacts the health of everyone.

Better cleaning and sanitation processes
Cleaning and sanitation can play their own critical role in controlling the spread of foodborne pathogens. PathoSans, a company whose philosophy is “The Clean that Says You Care,” long has been dedicated to the mission of effective and safe cleaning without the use of chemicals that can harm people, animals, or the environment. In the food industry, our solutions are found in food applications as diverse as restaurants and bakeries, fish processing firms, chicken hatcheries, and controlled environment agricultural facilities that employ greenhouses for large-scale production of fruits and vegetables. Our applications are found in the United States, China, Japan, New Zealand and Australia.

PathoSans’ successful approach to cleaning and sanitizing entails our ECAS (Electrochemically Activated Solution) technology. Employing only salt, water, and electricity, two effective compounds are created – PathoClean and PathoCide, which do their job together – first cleaning, then disinfecting — without the downsides of many alternative solutions, such as harmful, caustic chemicals, harmful odors or additives that can trigger allergies. They are also safer for the environment. This is a vital consideration; since growing food is part of our environment, why would we want to harm that very environment with chemicals that kill germs but may harm plants and animals?

Understanding the science of food safety
One of the keys to using the ECAS approach to control foodborne pathogens is to look closely at the science behind it. That’s why PathoSans has conducted laboratory studies and published the results in scientific journals. One such study, The Science of Food Safety, was published in Australia by the Royal Society of Chemistry. Another, Finding Better Ways to Protect Fruits and Vegetables After Harvest, was also published by the same organization. These studies are part of PathoSans’ ongoing commitment to develop better food safety approaches. This commitment is also reflected in our close collaborations with food industry clients to solve additional challenges.

The true meaning of a mission

Better food safety and healthier, more effective cleaning methods… these are two goals worthy of developing into a mission, rather than just a job.  Through our joint efforts on food safety education, policy improvements, and cleaning technology, we are fully dedicated to our mission. 

Part of that mission is to not only promise people better health, but to make good on those promises. Food health is one of the most critical human needs. Together, let’s work to get it right.

About the co-author: Tyler Williams oversees all product development, quality assurance and regulatory management that surrounds on-site electrochemical generators (OSGs) and product chemistry at PathoSans. Williams has a bachelor’s in science in chemistry from Purdue University and is a founding member of the Hypochlorous Acid (HOCl) Consortium which is charged with working with the EPA to advance the awareness and acceptance of HOCl.

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By Darin Detwiler

In reflecting on the evolution of food safety over the past three decades, we observe a landscape marked by significant and escalating legal actions against companies responsible for outbreaks and violations.  The effectiveness of these penalties, especially monetary fines, in preventing future lapses in food safety, merits a deeper examination.

  • Jack-in-the-Box: This 1993 multi-state E. coli outbreak sickened over 700 people across four states, resulted in over 170 hospitalizations and took the lives of four children. became a critical turning point in the U.S. for food safety awareness, regulation, and policy. However, the absence of state or federal charges against the company or its executives sent a message to the industry that, at that time, regulatory and legal frameworks might not sufficiently penalize or hold corporations accountable for lapses in food safety, potentially underestimating the importance of stringent food safety protocols and oversight. 
  • Jensen Farms:  This2011 Listeria monocytogenes outbreak tied to cantaloupe resulted in at least 147 illnesses across 28 states, with 33 deaths.  Today, this event is still the worst foodborne illness outbreak in the United States. The court sentenced the two owners each to five years’ probation, six months home detention, $150,000 in restitution and 100 hours of community service. 
  • DeCoster’s Eggs: The 2010 Salmonella outbreak led to one of the largest recalls in U.S. history, involving approximately 550 million eggs, as well as a nationwide public health crisis, affecting thousands. The 2014 trial and 2015 sentencing came with a $6.8 million dollar fine and saw the owners sentenced to prison, marking a rare instance where corporate executives faced jail time for negligence in food safety practices. The significance of the DeCosters’ egg outbreak and the subsequent sentencing lies in its establishment of a precedent for holding food company executives criminally responsible for food safety violations. This case underscored the seriousness with which the U.S. justice system began to treat food safety violations, signaling to the industry that leadership could be held personally accountable for the safety of their products, thus elevating the importance of rigorous food safety management within corporate culture.
  • Peanut Corporation of America (PCA): This 2008-2009 Salmonella outbreak traced to PCA’s products resulted in nine deaths and hundreds of illnesses across 46 states, leading to one of the largest food recalls (over 3,900 different types of products) in U.S. history. The 2014 trial and 2015 sentencing marked a stark escalation in the consequences for food safety failures, with numerous convictions and lengthy prison sentences for the executives involved. This case exemplified the judicial system’s growing resolve to treat food safety negligence as a grave legal and ethical breach.
  • ConAgra Grocery Products: This 2002 Listeria Outbreak, linked to contaminated peanut butter, marked a significant food safety incident. The outbreak resulted in widespread public health concerns, and, like the PCA incident, involved an extensive and lengthy investigation over the next five years. This incident led to one of the largest product recalls of its kind at the time, encompassing millions of jars of peanut butter sold under various brand names.  In 2015, ConAgra Grocery Products LLC agreed to plead guilty to federal charges related to the outbreak and was sentenced to pay an $11.2 million settlement, which included an $8 million criminal fine—the largest ever in a U.S. food safety case up to that point. 
  • Chipotle Mexican Grill: Multiple multi-state outbreaks between 2015 and 2018 involved multiple incidents of foodborne illnesses, involving various pathogens such as E. coli, Norovirus, and Salmonella linked to Chipotle. The subsequent federal fine of over $25 million dollars (the largest ever in a U.S. food safety case up to that point) underscored the importance of operational practices in ensuring food safety. This case also highlighted the reputational damage (stock values took 15 NYSE quarters of trading to recover) and financial penalties companies could face, even without criminal charges.
  • Blue Bell Creameries: The 2015 Listeria ice cream recall would result in Blue Bell pleading guilty (and paying criminal penalties totaling $17.25 million) to two counts of distributing adulterated food products in violation of the 1938 Federal Food, Drug, and Cosmetic Act 21 U.S.C. ch. 9 § 301 et seq. The court later sentenced the company to pay an additional $2.1 million to resolve civil False Claims Act (1863) allegations regarding ice cream products manufactured under insanitary conditions (and sold to federal / military facilities).  At the time, the $19.35 million in fine, forfeiture, and civil settlement payments constituted the second largest-ever amount paid in resolution of a food safety matter. This case further illustrated the increased financial and operational consequences for companies failing to adhere to food safety standards, emphasizing the role of top leadership in preventing such crises.
  • Family Dollar Stores LLC, a subsidiary of Dollar Tree Inc.: Most recent event involved egregious sanitation violations, including a severe and widespread rodent infestation, noted between 2020 and 2022, at Family Dollar Store’s West Memphis, AR, distribution center. The issues were so pronounced that they prompted a recall of all FDA-regulated products that came through that center from January 2021-February 2022, impacting over 400 stores across six states. The company entered into a plea agreement that includes a fine and forfeiture amount topping $41 million dollars – representing the current zenith of accountability.  Soon after this agreement, the company announced their decision to close over 1,000 stores. This case not only showcases the continued escalation of direct financial repercussions but also highlights the broader impact on food security and access in affected communities.

These escalating consequences from past outbreaks to the present day signal a clear trend (see graphic) towards greater accountability and, more so, stricter financial penalties for food safety failures.  Future cases will likely see even more stringent financial penalties, but will they include more significant operational impacts and personal accountability for corporate executives?

The substantial fines imposed on companies like Chipotle and Family Dollar Stores represent attempts to penalize and deter unsafe practices. However, these financial penalties must not be the end-all solution. Some may infer that the increase in corporate financial penalties has become the new industry tactic to avoid prosecution and prison time. True deterrence will come from a holistic approach that includes not just fines but also rigorous enforcement of the Responsible Corporate Officer (RCO) Doctrine, ensuring that individuals in positions of authority cannot evade personal accountability for violations of public welfare laws. 

History show us that fines, even those exceeding tens of millions of dollars, have not eradicated negligence. As fines grow larger, we must consider if they alone are sufficient to deter malfeasance or if they inadvertently allow wealthy corporations to bypass meaningful consequences. Consumers will feel the impact, both in terms of food safety and higher prices, if these fines become merely a cost of doing business for entities whose decisions are driven more by profit than by ethical considerations for consumer health and safety. 

  • The next big failure in food safety is not a matter of if, but when, and it will likely result from a combination of ignored warnings (perhaps even those related to ESG), systemic vulnerabilities, and unanticipated challenges. As food technology advances and the global supply chain expands, the complexity of maintaining food safety standards increases. 
  • This next big failure is likely to emerge not just from a gap in food safety practices but from a systemic undervaluation of rigorous ethical standards and a culture of compliance. The potential for failure grows not necessarily from a lack of knowledge or technology but from a failure to prioritize safety over profit at every level of decision-making.
  • This future landmark event may result not only in unprecedented penalties but could also drive a transformative shift in how food safety is integrated into the core values and operations of companies. 

Fines and legal actions will always be reactive measures – their impact never undoing the true burden to consumers forever harmed. In this era of rapid technological advancement and increasingly global supply chains, the next failure in food safety is preventable not by fear of financial loss but through a steadfast commitment to the principles of public health and safety.

To ensure that the next landmark in food safety is not a failure but a success story of prevention, we must focus on a foundation of ethical leadership and accountability that permeates every level of the food industry. Proactive, ethical decision-making that places consumer welfare at the forefront must be ingrained in every decision, from daily operations to strategic planning. To support this, the courage to prioritize food safety must be cultivated, validated, and even celebrated. 

Let us learn from the past not to predict failure but to pave the way for a future where food safety failures become historical anomalies, not recurring headlines. To prevent becoming the next cautionary tale, companies across the food industry must prioritize food safety as a central pillar of their corporate responsibility. 

By learning from past mistakes and embracing innovation in risk management, the food industry can aim not just to react to crises, but to prevent them. In doing so, the food industry will protect not only its consumers but also its own future.

About the author: Darin Detwiler is a food safety academic, advisor, advocate, and author.  For nearly 30 years, he has played a unique role in controlling foodborne illness.  After losing his son, Riley, to E.coli in 1993 Jack in the Box outbreak, the Secretary of Agriculture invited Detwiler’s collaboration on consumer education.  He was twice appointed to the USDA’s National Advisory Board on Meat and Poultry Inspection, represented consumers as the Senior Policy Coordinator for STOP Foodborne Illness, served on Conference for Food Protection councils, and supported the FDA’s implementation of FSMA. Detwiler is a professor of food policy and corporate social responsibility at Northeastern University.  He is chair of the National Environmental Health Association’s Food Safety Program. 

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— OPINION —

In the aftermath of the groundbreaking plea agreement with Family Dollar Stores LLC, entailing a fine and forfeiture totaling $41.675 million for storing food, drugs, medical devices, and cosmetics in unsanitary conditions, we are starkly reminded of the imperative for stringent regulatory enforcement within the domain of food safety. This agreement, representing the largest-ever monetary criminal penalty in the context of food safety, serves as a vivid indicator of the justice system’s intensifying resolve in addressing such transgressions. This occasion necessitates reflection on historical incidents where the lack of such decisive actions had catastrophic outcomes, emphasizing the critical need for prompt and determined interventions.

The 1993 E.coli outbreak linked to Jack in the Box restaurants stands as a harrowing instance. This tragedy, which resulted in the death of my son, Riley, along with three other children and afflicted more than 700 individuals across several states, was a direct result of the company’s non-compliance with state-mandated minimum cooking temperature regulations. Astonishingly, the incident led to no state or criminal charges against the company for these fatalities. Had the judiciary imposed penalties comparable to those seen today, it might have sent a formidable message to the industry, potentially preventing subsequent food safety failures.

In recent years, we have witnessed significant legal actions, including:

·       In 2023, Kerry Inc. agreed to a $19.228 million fine and forfeiture for manufacturing ready-to-eat breakfast cereal under unsanitary conditions. 

·       In 2020, Chipotle Mexican Grill Inc. agreed to pay $25 million to settle criminal charges related to at least five foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018.

·       Also in 2020, Blue Bell Creameries L.P. agreed to pay a total of $19.35 million after having pled guilty to two misdemeanor counts of distributing adulterated ice cream products– stemming from their shipping of contaminated products linked to a 2015 listeriosis outbreak.

·        In 2015, ConAgra Grocery Products agreed to a plea agreement totaling $11.2 million after having pled guilty in the salmonella case involving Peter Pan peanut butter in a 2006-2007 salmonella outbreak.

These cases and others illustrate a trend toward acknowledging the severe nature of these violations and the paramount importance of public health. The evolution of legal and regulatory responses reflects a growing recognition of the necessity for accountability and the efficacy of punitive measures in averting future violations.

The sentencing of officials from the Peanut Corporation of America (PCA) in 2015, where I witnessed the proceedings, represents a milestone in judicial responses to food safety infractions. The severe penalties imposed in this case (a sentence length far greater than the three-month sentencing seen in the trial of the owners of DeCosters Eggs) testify to the judiciary’s potential to instigate significant industry-wide changes, ensuring that consumer health and safety are prioritized. 

The prison sentences in the PCA case, along with the large settlements and fines in recent cases, serve not merely as a deterrent but as a catalyst for establishing comprehensive food safety cultures within organizations. The escalating fines highlight the increasing financial, operational, and reputational risks companies face that disregard their fundamental obligation to ensure product safety. This trend toward harsher penalties mirrors a broader societal call for corporate accountability, especially concerning public health.

This shift is a clarion call to the industry: lapses in food safety, propelled by negligence or disregard for established protocols, will not be tolerated. For companies that have embarked on rigorous efforts to safeguard consumer health, these developments affirm their endeavors to protect every plate. For others, it should serve as a wake-up call, compelling them to evaluate the costs of doing nothing. ALL food industry entities must prioritize implementing exhaustive safety measures, engage in vigilant oversight, and cultivate a culture that places consumer safety at its core.

While the recent legal actions signify substantial progress in the crusade for food safety, they also serve as poignant reminders of the tragedies that could have been averted through earlier and more decisive interventions. The movement toward more severe penalties for food safety violations is a positive evolution, signaling a commitment to holding companies accountable and preventing future outbreaks. This momentum must be sustained, ensuring that the lessons learned from past incidents propel continuous improvement in food safety standards and practices across the industry, thereby safeguarding the health and well-being of the public.

About the author: Darin Detwiler is a food safety academic, advisor, advocate, and author.  For more than 30 years, he has played a unique role in controlling foodborne illness, including service on the USDA’s National Advisory Board on Meat and Poultry Inspection, representing consumers at NGOs, serving on Conference for Food Protection councils, and supporting the FDA’s implementation of FSMA.  Detwiler is a Professor of food policy and corporate social responsibility whose research and insights have appeared on television, such as Netflix’s 2023 documentary “Poisoned,” and in print, including his book “Food Safety: Past, Present, and Predictions.” In addition to his current role as the Chair of NEHA’s Food Safety Program Committee, his leadership capacities include the FDA Foods Coalition and numerous advisory and editorial boards, and he has long consulted on food safety issues with industry in the U.S. and abroad. Detwiler is the recipient of the International Association for Food Protection’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award and their 2018 Distinguished Service Award for dedicated and exceptional contributions to reducing risks of foodborne illness.

— OPINION —

Today, September 18, would be my son, Riley Detwiler’s 32nd birthday.  

Earlier this year, I had the privilege and heartache of being part of the recently released Netflix documentary, “Poisoned: The Dirty Truth About Your Food.” In addition to offering insights from my food safety career over the past 30 years, I recounted the harrowing experience of losing my 17-month-old son Riley to the landmark 1993 E.coli outbreak linked to fast food hamburgers. While Riley’s story has long been held as a poignant reminder of the devastating impact of foodborne illness, his chair will sit forever empty at our family table.  

Participating in the documentary was more than a personal journey for me; it was an opportunity to lend my voice to a chorus of families who have endured the pain and suffering caused by failures in food safety. Through sharing my family’s story, I felt a profound sense of duty and responsibility to honor the experiences of others impacted by failures in food safety. I wanted to ensure that these families, who forever live with an empty chair at their tables, are not relegated to the shadows of anonymity.

The documentary not only memorializes Riley’s story, but it also shines a light on a broader truth — the reality that foodborne pathogens claim the lives of around 3,000 Americans each year. This staggering toll remains largely invisible, shrouded in the silence of those who have suffered. I have seen “Poisoned” three times and each viewing has left me feeling overwhelmed by emotion as the documentary bridges the gap between individual tragedy and collective awareness.  At the viewing in New York during the documentary’s premiere with a live audience at the TriBeCa Film Festival, I couldn’t help but draw parallels between the 9/11 Memorial and the narrative unfolding on the screen

At the 9/11 Memorial in New York City, I was struck by the power of remembrance — a tangible tribute to the lives lost and the collective grief borne by a nation. The names etched into those solemn panels serve as an enduring testament to the tragedy that unfolded on that fateful day. Yet, as I gazed at the memorial, a poignant thought emerged: where is our national memorial for the thousands of lives claimed annually by foodborne pathogens? 

While the 9/11 Memorial stands as a symbol of remembrance, “Poisoned” represents something more — a call to action, a movement for change, and a tribute to resilience. This film is a powerful reminder that our fight for improved food safety is not just about individual lives, but a collective commitment to preventable suffering.

One of my deepest hopes is that “Poisoned” will serve as an inspiration for others to share their food safety stories. In terms of victims, I once read that “One of the most valuable things we can do to heal one another is listen to each other’s stories.” I can tell you from 30 years of being in my situation that this is 100% true.  I am also eager to hear more accounts of food safety leaders, executives, and policymakers about their own experiences and inspirations. Every story has the potential to drive transformation, to influence policies, and to cultivate the courage required to safeguard the food we consume.

Food safety is not an abstract concept; it is a matter of life and death, of family unity, and community well-being. While my journey through grief has been arduous, it has also forged in me a determination to call out the Herculean effort behind food safety and to inspire change, — a fire to ensure that others do not suffer the same fate. As such, I believe that this documentary’s release is a catalyst, a pivotal moment in the trajectory of our collective fight for safer food systems.

To all those who have endured the heartache of losing a loved one to foodborne illness, I stand with you. “Poisoned” is not just a story; it is a pledge. A pledge to ensure that the empty chairs at our tables become fewer and farther between. A pledge to hold the food industry accountable and demand transparency. A pledge to honor the memory of those we have lost through meaningful change.

As the credits rolled at the premiere, I was filled with a sense of both sorrow and hope: the sorrow for the lives we have lost and the pain endured, and the hope that this film will resonate far and wide, propelling us all toward a future where foodborne illness is a distant memory. Let “Poisoned” be a clarion call for courage and for the unwavering commitment to a safer food landscape. Let it be the catalyst that turns individual stories into a resounding narrative of change, and, until we have some kind of monument beyond those found in far too many families’ homes, let it serve as a memorial that our loved ones deserve.

I urge everyone to watch “Poisoned: The Dirty Truth About Your Food” and share in this journey of remembrance, transformation, and hope. Let us create a world where fewer and fewer chairs remain forever empty due to failures in food safety.

Riley Detwiler

About the author: Darin Detwiler is an author, consultant, speaker, and is regarded as a “Food Safety Icon.” He is an Associate Professor at Northeastern University.  Over the past 30 years, he has served in appointed advisories for the USDA, represented NGOs, served on CFP councils, and supported the FDA’s implementation of FSMA.  He is the Chir of NEHA’s Food Safety committee.  His books – Food Safety: Past, Present, and Predictions and Building the Future of Food Safety Technology – are used in multiple universities. Detwiler  is the recipient of the IAFP’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award as well as their 2018 Distinguished Service Award for dedicated and exceptional contributions to the reduction of risks of foodborne illness.

— OPINION —

When you are sitting comfortable at home feeding your kids or going out to dinner, remember that there are a lot of people that have your back. I will be profiling them over the coming days as ‘Poisoned’ begins streaming on Netflix. Darin Detwiler has always been one of my heroes – even before he became a Netflix star.

Dr. Detwiler is a well-respected food safety academic, advisor, advocate, and author.  For nearly 30 years, he has played a unique role in controlling foodborne illness.  After losing his son, Riley, to E.coli in 1993, the Secretary of Agriculture invited Detwiler’s collaboration on consumer education.  He was twice appointed to the USDA’s National Advisory Board on Meat and Poultry Inspection, represented consumers as the Senior Policy Coordinator for STOP Foodborne Illness, served on Conference for Food Protection councils, and supported the FDA’s implementation of FSMA. 

Today, Detwiler is a Professor of food policy and corporate social responsibility at Northeastern University, where his students have gone on to leadership positions in industry and in state and federal agencies.  Detwiler’s research and insights have appeared on television and in print, including his column and articles in Quality Assurance and Food Safety Magazine and his books Food Safety: Past, Present, and Predictions and Building the Future of Food Safety Technology: Blockchain and Beyond.  In addition to his current role as the Chair of the National Environmental Health Association’s Food Safety Program, his leadership capacities include numerous advisory and editorial boards as well as having long consulted on food safety issues with industry in the U.S. and abroad. 

A U.S. Navy Nuclear Submarine Veteran, and a former high school teacher, Detwiler earned his doctorate in Law and Policy, focusing on states’ ability to implement federal food policies.  He is the recipient of the International Association for Food Protection’s 2022 Ewen C.D. Todd Control of Foodborne Illness Award as well as their 2018 Distinguished Service Award for dedicated and exceptional contributions to the reduction of risks of foodborne illness.

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The documentary “Poisoned: The Dirty Truth About Your Food” makes its Netflix debut on Wednesday, Aug. 2. 

Based on the bestselling book “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat,” the film delivers a shocking exposé that will resonate with consumers, the food industry, regulators, politicians and all those concerned about food safety.

The documentary is based on Jeff Benedict’s 2013 book.

“Poisoned” serves as a call to action for officials with the power to mitigate the dangers posed by foodborne illnesses, which claim thousands of lives annually in the U.S. It also lays bare an alarming indictment of the food industry and regulatory system, showcasing how decades of apathy and misconduct have left American consumers vulnerable to such deadly outbreaks.

The documentary is directed by Stephanie Soechtig, known for her works such as “Under the Gun”, “Fed Up”, and Netflix’s “Knock Down the House.” Jeff Benedict, author of “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat”, is executive producer alongside Rebecca Evans and Ross Girard, with Ross M. Dinerstein and Kristin Lazure as producers. Rod Hassler serves as cinematographer on the project, and Justin Melland is the composer.

The documentary heavily features Food Safety News‘ Publisher and food safety lawyer Bill Marler, as well as people personally impacted by foodborne illness, such as Darin Detwiler, who lost his 16-month-old son Riley to E.coli during the 1993 Jack in the Box outbreak.

The Food Safety News team watched the documentary and gave some early reviews:

(Warning: spoilers ahead)

— — —

Dan Flynn, Editor in Chief

Dan Flynn

When author Jeff Benedict first wrote “Poisoned,” he followed in the  tradition of Upton Sinclair’s “The Jungle.”  The socialist Sinclair wanted to draw support for Chicago’s slaughterhouse workers, but as he said, “I aimed at the public’s heart and by accident hit its stomach.”

The film version of Poisoned is laser-focused on telling the food safety story of the past 25 years or so. Using both archival film and some focused contemporary reporting, “Poisoned” catches up the viewer with how food safety has evolved since the infamous hamburger outbreak of 25 years ago and what’s happened since.

The documentary makes mincemeat of the belief that food safety in the United  States is the safest in the world. In “Poisoned,” we see one gap after another in U.S. food safety. The film shows how Salmonella in chicken remains unsolved in the U.S. while ‘pathogen-free’ chicken is found for sale in Europe.

The film also documents how concentrated animal operations spread dangerous E. Coli O157:H7 on the nearby Romaine fields.

The viewer will leave “Poisoned” knowing enough to take defensive food safety measures and not rely on ‘the system.’  That means “Poisoned” is likely one of the most important documentaries you will ever see.

— — —

Coral Beach, Managing Editor

Coral Beach

If you believe that the United States has the safest food supply in the world, you need to watch “Poisoned.” This movie takes the viewer on a journey with victims’ families, government regulators and industry leaders telling the story of food poisoning in America. 

If there is one takeaway from “Poisoned,” it is that the American government can have success stories, but that it still has work to do. After the deadly outbreak of E. Coli infections traced to Jack in the Box hamburgers in 1993 the top food safety official at the USDA declared it illegal to sell hamburger contaminated with E. Coli O157. 

This documentary shows how the current USDA leadership needs to take the same action regarding Salmonella in poultry. And, the Food and Drug Administration needs to be able to enforce common sense regulations for foods such as romaine lettuce grown in close proximity to animal feedlots.

Viewers will be moved to tears and outraged at the status of food safety in our country, and will hopefully be motivated to contact their representatives and senators and tell them — not ask, but tell them — to act now for safer food.

— — —

Joe Whitworth, Staff Writer

Joe Whitworth

Food safety is something most people take for granted and the topic only gets attention when it goes wrong. There are many passionate people working every day to ensure safe food but the figures on foodborne disease remain high and don’t seem to be improving.  

Watching “Poisoned” reminds us all that the statistics showing 48 million sick each year in the United States are people like you and me and while illness might be mild for many, 3,000 die annually. Often it is the most vulnerable – either young children or older adults – that suffer the most. 

The food system is extremely complex with lots of moving parts in supply chains that are global but while food safety is everyone’s responsibility, there needs to be accountability to drive the seriousness of the message home for industry.  

Whether it is a one-off mistake, complacency or blatantly ignoring regulations, those in the food sector must learn when something they produce, handle, distribute or sell causes an outbreak, and regulators need to assess the gaps in legislation to avoid repeated incidents.  

“Poisoned” does not try to cover every issue from all angles, which would overload the viewer. It will give people the initial vibe that something is not right with the system and the hunger to find out more for themselves. 

— — —

Jonan Pilet, Staff Writer

Jonan Pilet

“Poisoned” exposes the dark side of the food industry, revealing crime, corruption, negligence and waste. This wake-up call should leave viewers rightfully angered by a system that jeopardizes their health. While the film feels hopeless at times, it highlights progress and urges consumers to pressure Congress to make needed changes. The documentary excels in explaining the American food system and the current issues being faced, backed by a captivating score, sharp editing and top-notch production. It vividly showcases the severity of the U.S. food safety crisis and humanizes victims through their poignant interviews.

As someone who follows and reports on the impact of foodborne illness, I hope “Poisoned” sparks crucial attention and action. The alarm has been sounded on the country’s largest streaming platform. How will American consumers respond?

— — —

Cookson Beecher, Contributing Writer

Cookson Beecher

I remember it so well. It was almost dark, raining hard, cold and dismal. Early winter in 1993. As I waited to cross the street, I saw a newspaper headline about yet another child stricken with something called E. coli. The picture of the child was heartbreaking. Many children were in the hospital and one had already died.

It was scary news . . . as though an invisible killer was amongst us. But what was it? And what, if anything, could be done about it?

Fortunately, state health inspectors managed to trace the problem to the “Monster Burgers,” sold at a special discounted price at some of the Jack in the Box fast-food restaurants.  Ironically, the slogan in the promotions was “So good it’s scary!”

“Poisoned” is a movie described as a ‘legal thriller.’  Although this played out in the courtroom, it goes past the legal chambers and into our own lives. Because it did so much to clean up the way the nation’s ground beef is produced, we’ve all come out as the winners.

— — —

Watch the trailer and once you’ve seen the film on Aug. 2, we’d love to hear from you. Submit your thoughts on the film in the comments section below this story.

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