“I am confident in the safety of the food I eat.” Five years ago, only one-third of U.S. consumers strongly agreed with this statement. While they held the government primarily responsible for food safety, followed by food companies and farmers, when it came to trusting them, farmers were third, federal regulators were eighth, and food companies were eleventh. And we in food safety wonder why consumers don’t always adhere to good food safety practices or follow label instructions. How can food safety experts from government, industry and academia communicate with consumers in a meaningful way? How can we convey that just because something can happen, the likelihood that it will happen varies? And how can we convince consumers to take steps to reduce their risk of foodborne illness?

The 2023 virtual Food Safety Forum, organized by the American Frozen Food Institute (AFFI), will address these questions and more. Taking place Sept.13 and free to attend, the Food Safety Forum is taking a deep dive into the state of risk communications. Science is complicated. Consumers want simple, unambiguous answers, and misinformation is abundant. Effective communication is hard and communicating public health risk — the likelihood that one will get sick, not to be confused with hazards — is an ongoing challenge. 

Like it or not, food safety professionals are risk communicators. Family and friends often ask for my opinion when they see alarming headlines about the safety of our food supply. On a broad scale, scientists are seldom viewed as great communicators and most of us are not trained that way. But facts and data don’t speak for themselves. Most consumers prefer a “tell me what to do” approach rather than delve into the complexities of contamination rates and dose responses. AFFI’s Food Safety Forum is bringing together the right group of experts from diverse backgrounds to address these topics with the goal of communicating in a way that improves public health. 

Perhaps the most notable component of the Food Safety Forum is the breadth of stakeholders from industry, government, academia and consumer groups, that all see the need for better communication of food safety risks. Many of these groups, historically viewed as adversaries, have common goals: we all want safe food and for consumers to view and act on food safety risks appropriately. The collaboration and diversity of partners for this year’s Food Safety Forum are unprecedented.

The event will kick off with the well-known Don Schaffner of Rutgers University discussing the “Current Reality of Risk Communication.” As co-host of the “Risky or Not” podcast, Don is perfectly positioned to talk about risk as distinct from hazards in a food safety context and how to explain these concepts to consumers.

No discussion of food safety communication would be complete without addressing the elephant in the room: lawyers. Whether it’s communicating about a serious outbreak, a recall that warrants immediate action or safe food handling practices, regulators are often criticized for being too slow, too fast and rash, too simplistic or too complicated. Elizabeth Fawell, an attorney with the Hogan Lovells law firm, will moderate a discussion with experts who know first-hand the challenges public health officials face when trying to clear food safety communications internally. Joining to share learnings from their experiences are Brian Ronholm with Consumer Reports, former deputy undersecretary for food safety with the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS), Roberta Wagner with the International Dairy Foods Association who formerly worked with the U.S. Food and Drug Administration and FSIS, and Frank Yiannas, former deputy commissioner at the FDA. 

Consumers are the ultimate target of food safety communications. When it comes to educating and empowering people to make informed decisions about food safety risks, the rubber meets the road for the scientific community. Who is better to address the consumer view than Mitzi Baum of STOP Foodborne Illness, who represents families of consumers impacted by foodborne illness? Joining Baum are Kristine Butler with FDA’s communications and public engagement team, Ben Chapman with North Carolina State University (and the other half of the “Risky or Not” podcast), and communications representatives from food retail and national food brands. Together, these communicators will speak to their mechanisms to earn trust and gain attention.

Finally, the Food Safety Forum will look to the future. How can risk communicators learn from previous missteps? How can we break through the noise? How can we narrow the gap between mitigating food safety hazards and communicating public health risks? Representatives from the Association of Food and Drug Officials, Consumer Reports, the Centers for Disease Control and Prevention and the food industry will discuss the lessons learned and what it means for the future of communicating food safety to consumers.

Moving the needle on consumer behavior is a lofty undertaking and discussion is needed on how to identify effective communication mechanisms and overcome barriers to meaningful communications. The collaborators convened by AFFI come from different perspectives but are united by their commitment to not only improve food safety, but to also improve consumer understanding of complex food safety topics so they can best protect their health. This topic is not going away. Attend this free event on Sept. 13 to learn more about current challenges and approaches for the future. Register now at www.affi.org/food-safety-forum.

About the author: Jennifer McEntire, Ph.D., is the Founder of Food Safety Strategy LLC. With 20 years of food and beverage association experience, she combines her technical background and regulatory insights to help the food industry assess and manage food safety risks in order to protect public health. McEntire earned a B.S. in food science from the University of Delaware and Ph.D. from Rutgers University as a USDA National Needs Fellow in food safety.

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By Mitzi D. Baum, M.Sc., CEO for Stop Foodborne Illness

Stop Foodborne Illness (STOP) was born in 1994, the same year in which September was dedicated as National Food Safety Education month (NFSEM). As we quickly roll into September, I believe it’s important to reflect on the importance of both STOP and NFSEM and their contributions to public health.

STOP was formed (originally as Safe Tables Our Priority) to raise awareness and change the status quo in food safety inspection policies that were not in sync with current science. Consumers were not protected from emerging pathogens and were paying the ultimate price with their lives; four of them were children.

Through tears and pain, the parents of the children that were permanently injured or succumbed to the foodborne illnesses fought for changes in food policy that would impact everyone who eats. The first of these policy changes, in 1994, was the declaration of E. coli O157:H7 as an adulterant in ground beef. By these courageous individuals telling their horrific lived experiences brought on by food poisoning, politicians and regulatory officials made bold moves. 

NFSEM is meant to educate consumers – not the food safety industry. Let’s be honest, we regularly preach to ourselves about the fundamentality of our work. NFSEM is designed to move beyond the small world of food safety professionals to engage the community at large. This is an opportunity for all food safety professionals – that work to reduce the risk of foodborne illness – to bring attention to the amazing unrecognized work performed every day in food manufacturing, retail, and food service establishments.

There is a reason that U.S. consumers assume the foods they purchase and consume are safe – it’s because of YOU. And as a community of individuals, food producers and growers, companies, regulatory agencies, and consumer advocacy groups that are focused on food safety and risk reduction, this is our collective opportunity to engage beyond those of us that are ‘in the know’.

It’s essential that the food safety community engage in the educational component of our work to the outside world. Stop Foodborne Illness sees the need for the industry to coalesce around this issue in a way that is simple, accessible, and educational while raising awareness of food safety. STOP3000 is a 30-day challenge for everyone to walk 3,000 steps each day in September to commemorate the estimated 3,000 lives lost annually in the U.S. due to food poisoning. Consider this, since 1994 over 87,000 individuals have died because of something they ate.

We, at STOP, urge you to take the challenge, sign up, raise awareness, share food safety tidbits, and support our work by participating in our third annual STOP3000. STOP operates solely on donations – we can’t do our work without the support of the food safety community. We are grateful to our sponsors this year: Chick-fil-A, Conagra Brands, Saldesia – Goddess of Food Safety, Image Base, Kelleher Consultants, LLC, and ASI Food Safety.

STOP is “The Voice for Safe Food”. This September, help us expand our voice to improve food safety and reduce the incidence of foodborne disease.

Check us out at: https://stopfoodborneillness.org/stop3000-2023/

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In June 2023, the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) issued new Directives and a Notice regarding the regulation of cell cultured food products derived from cell lines of USDA-amenable species. These newly-released USDA-FSIS documents —  Directive 7800.1, Directive 5730.1, and Notice 31-23 — address the inspection, sampling, and responsibilities of establishments producing cell-cultured meat and poultry products also commonly referred to as cultivated meat. 

With the publication of these Directives and Notice, we now have much more clarity on how USDA-FSIS plans to execute its regulatory obligations in this space, fresh off the heels of the agency’s June 2023 issuance of federal grants of inspection to two U.S. cell-cultured chicken manufacturers and approval of their cell-cultured chicken labeling.  USDA’s actions also both follow FDA’s relatively recent issuances of “no-questions” letters to both companies finding that the companies’ products “are as safe as comparable foods produced by other methods.” According to FDA Commissioner Robert Califf and the FDA’s director of the Center for Food Safety and Applied Nutrition, federal agencies are “committed to supporting innovation in the food supply” and working collaboratively with USDA-FSIS in a joint regulatory framework.

Meat from cells? 

In 2013, Dutch scientist Mark Post showcased the first cell-cultured meat burger on live television. Since then, the industry has ballooned to more than 150 companies and counting on 6 continents, propelled by $2.6B in investments, by some estimates. 

Harnessing cell culture technology to produce food or cellular agriculture refers to the production of agricultural products from cell cultures, like meat, poultry, and seafood ex vivo, grown outside the animal. Each company’s manufacturing process for animal cell-based food products varies, in part, depending on the type of cell line used (e.g., livestock, poultry, fish or seafood) and the nature of the final product (e.g. nuggets or steak). That said, at a high level, the key manufacturing stages include (1) target tissue or cell procurement, selection, isolation, preparation and storage, (2) cell proliferation, as well as possible cell differentiation, during biomass production (in a specially designed bioreactor) (3) cell harvesting, and (4) processing and formulation of food products. Each stage can potentially include various sub-steps dependent upon on the source and desired final food type. Manufacturers aim to produce a finished product that replicates the characteristics of muscle harvested from food-producing animals.  

How Are Cell-Cultured Foods Regulated?

USDA-FSIS and FDA jointly regulate cell-cultured food products derived from cell lines of livestock and poultry under a 2019 Formal Agreement. FDA oversees the pre-harvest production phase of the animal cell culture technology process for all cell-cultured foods. For cell-cultured meat and poultry derived from cell lines of USDA-amenable species, jurisdiction then shifts to USDA-FSIS at the point of harvest. Consistent with the Formal Agreement, any company producing USDA-regulated cell-cultured foods must obtain a federal grant of inspection from USDA-FSIS. That agency oversees the harvesting, processing, packaging, and labeling of such foods. In particular, USDA-FSIS subjects labels under its purview to preapproval and is developing new labeling requirements for cell-cultured meat products consistent with its 2021 Advanced Notice of Proposed Rulemaking (ANPR).

For all other cell-cultured foods falling outside USDA-FSIS oversight– such as most seafood and meat from non-USDA-amenable species (such as elk, deer, antelope, and certain other species). FDA maintains oversight for the duration of the entire production process. 

What’s in the New USDA Directives and Notice?

The new USDA-FSIS Directives clarify the regulatory oversight of cell-cultured meat and poultry products pursuant to the 2019 Formal Agreement. Companies producing such products should review the directives in depth, and highlights are presented below.

• Regulated Like Conventional Meat and Poultry Products: The Agency emphasizes that cell-cultured meat is subject to the same regulatory requirements and oversight authority as conventional meat and poultry. 
• No Generic Approval: Labels applied to USDA-FSIS regulated cell-cultured meat or poultry must be submitted to the agency for review and approval before they are used in commerce (e.g., “sketch approval” in USDA-FSIS parlance).
• Dual Jurisdiction Establishments: Facilities that harvest cell-cultured meat and poultry products are Dual Jurisdiction Establishments — meaning that they are regulated by both FDA and USDA-FSIS. As noted above, FDA oversees the pre-harvest production phase, and USDA-FSIS, which inspects harvest and any postharvest production that may occur in the same establishment. 
• Restrictions on Imports and Exports: Cell-cultured meat and poultry products may not be exported into the United States unless the agency has determined that the foreign country has “a regulatory food safety inspection system that is equivalent to that of the United States for the production of cell-cultured meat or poultry food products.” When USDA-FSIS deems a country to be equivalent for such products, it will add the country as eligible to export “cell-cultured” meat or poultry food products to the United States by species in the agency’s import library. Cell-cultured meat and poultry food products are subject to the same USDA-FSIS import and export regulations and policies as meat and poultry food products derived from slaughter.
• Substances Must Be Considered Safe and Suitable: Ingredients, including processing aids, used pre-harvest that remain in the harvested cells and any ingredients used post-harvest must be considered safe and suitable for use by USDA-FSIS and used in accordance with applicable standards, namely 9 C.F.R. § 424.21(c) or Directive 7120.1 (Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products). Ingredients that do not appear in 9 C.F.R. § 424.21(c) or Directive 7120.1 require a technical review, as described in Directive 5020.2 (The Technical Review Process).
• Ingredients already authorized for use in conventional meat and poultry.  Ingredients listed as approved for meat and poultry by USDA-FSIS regulation or Directive 7120.1 may be used in cell-cultured meat and poultry food products if the ingredient’s intended use aligns with the application (i.e., as an antimicrobial dip or as an ingredient component), product type (i.e., for use on whole-muscle or comminuted  product), and any other enumerated criteria. USDA-FSIS also explained that manufacturers must compare Directive 7120.1 to other applicable requirements, such as those for standard of identity to determine whether an ingredient (e.g. an antimicrobial or binder) can be used in a particular product. As noted above, if an ingredient is not listed at 9 CFR 424.21(c) or Directive 7120.1, then the ingredient requires a technical review under Directive 5020.2.

• Inspections:USDA-FSIS inspectors will examine a facility’s operations at a minimum of once per shift.

In addition, USDA-FSIS Notice 31-23 discusses food safety and process controls. Among other things, raw products samples will be tested for Aerobic Count (AC), Salmonella, chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products will be tested for AC and Salmonella. Ready-to-eat product samples will be tested for AC, Listeria monocytogenes (Lm), chemical residues, speciation, and pathology. Food contact surfaces and environments at facilities producing raw products at establishments producing Ready-to-Eat products will be tested for AC and Lm. Samples will be at least 60 grams and collected from every other batch until at least 10 samples are collected.

What’s Next?

Cell-cultured meat and poultry products have officially arrived in the U.S. marketplace and are poised to enter the market more broadly in the coming years. Already, USDA-FSIS approved labeling and issued grants of federal inspection services to two U.S. cell-cultured poultry manufacturers in June 2023. These companies also both recently received FDA “no-questions” letters finding that the companies’ products “are as safe as comparable foods produced by other methods.” As these products move to market, companies should take care to comply with a complex dual jurisdiction environment and obtain regulatory approvals necessary from both FDA and USDA-FSIS.

About the authors:

• Brian P. Sylvester is a partner in Perkins Coie’s Washington office. A former USDA regulatory counsel, he advises emerging and established companies in the food, beverage, and agricultural biotechnology sectors, with an emphasis on innovative foods.  He is a leading authority on food tech regulation and serves as a trusted advisor to global brands, startups, life science companies, investors, and trade associations.

• Tommy Tobin, is an associate in Perkins Coie’s Seattle office. He is a Lecturer at UCLA Law, where he teaches a seminar on Food Litigation. Tommy edited the ABA’s Food Law: A Practical Guide, a resource book for practitioners to assist them in meeting the unique needs of food and beverage clients across various domains of legal practice.

Food safety is a significant concern for both consumers and the food service industry. Ensuring that the food we consume is safe to eat is of utmost importance, and the application of Artificial Intelligence (AI) in the food industry has been widely recognized as a promising solution to address this issue.

Building consumer trust is an essential effort. The CDC estimates that 48 million people get sick,128,000 are hospitalized, and 3,000 die from foodborne diseases in the US each year.

As consumers continue to read frightening headlines about food recalls, foodborne illness incidents, and other food safety breaches, they’re demanding transparency more than ever before. The food industry should, therefore, continue to explore the potential applications of AI in food safety to ensure that consumers can have greater confidence that the food they consume is safe.

As AI grows more affordable and accessible for organizations of all sizes and budgets, it will become an increasingly essential tool to boost transparency, verification, validation, traceability, communication, and safety throughout the entire supply chain.

Predictive modeling and quality control
AI can help enhance food safety in several ways. Predictive modeling is one of the most prominent applications of AI in the food service industry. AI algorithms can predict potential foodborne illness outbreaks by using data gathered from various sources, such as environmental factors, ingredient quality, processing operations, and historical records of contamination. The information obtained can be used to proactively take action to prevent such outbreaks from happening.

Another way in which AI can increase food safety is through food quality control. AI algorithms can analyze images of food and packages in real-time to detect abnormalities, such as missing labels or torn packaging. This helps identify contaminated products before they reach store shelves (or consumers).

Food safety can also be enhanced through AI-powered automated food processing systems. By using sensors and cameras, these systems can detect and correct issues like temperatures, liquid levels, gas flow, humidity, and even food hygiene that could lead to food contamination during manufacturing and processing.

Additionally, AI can be used to trace the origins of food products. Using technology and AI algorithms, food producers can track food products from farm to table, providing consumers greater transparency and accountability in the food supply chain.

Ways that AI will improve food safety
Creating AI with verification and validation checkpoints is essential to improving traceability within the supply chain.

AI will improve food safety throughout the supply chain by:

• Improving communication. Good communication is a critical aspect of verification, validation, and traceability. Strong, accurate, real-time communication is essential throughout the food chain to maximize safety, transparency, and trust. 
• Boosting transparency and validation. Everyone in the supply chain must understand the importance of validation and transparency and the role they play. This will help build consumer trust and confidence in the food produced.
• Making the process faster and easier. AI will minimize the number of steps it takes to get validated and the number of people suppliers must talk to during the process. As a result, more suppliers will participate.
• Reducing redundancies. AI will decrease the number of databases that companies have to work with, reducing the redundancies that come with duplicating information in each database. Since these redundancies waste time, labor, and money, AI will help the processes be more efficient, cost-effective, and streamlined, reducing administrative burden dramatically.
• Simplifying the process. The newest AI technologies make these systems simple, straightforward, and multi-faceted rather than complicated with minimal functionality. It’s time to work smarter, not harder!

Reliability and cost factors
However, as with any technology, the use of AI in food safety has its challenges. One major concern is the reliability of AI models. AI models are only as good as the data that is entered, and if the data is flawed or biased, the AI model will produce unsatisfactory results. 

Additionally, there are concerns about the cost of implementing AI in the food industry and the potential for job loss due to automation. Though the use of AI in food safety should not replace human labor entirely. For example, food safety inspections and quality testing will continue to require human involvement to ensure the food meets safety standards and regulations. AI is also expected to create job opportunities in various fields, such as software engineering, data science, and quality control.

However, it’s important to note that the affordability and accessibility of AI may depend on various factors, such as the type of technology, infrastructure availability, and cost of implementation. Tech investments can also have a tremendous ROI, as AI can increase efficiency and reduce costs, and there are even currently affordable options for small businesses.

Despite these challenges, the potential benefits of using AI to enhance food safety are significant. By providing real-time monitoring, detection, and prediction, AI can help to prevent foodborne illness outbreaks, reduce food waste, improve sustainability, and enhance accountability in the food supply chain. 

About the author: Francine L. Shaw, food safety specialist, podcaster, and co-founder of My Food Source, is a successful entrepreneur, author, and speaker who spent 20+ years working in the foodservice industry. Her career has included performing services (operating partner, corporate/private trainer, health inspector, 3rd party inspector, adjunct professor) in various sectors of the foodservice industry. She has written hundreds of articles for national trade magazines and appeared on Dr. Oz, the BBC World Series Radio, and iHeart Radio as a food safety expert. 

Soft fruits like strawberries, raspberries, blackberries, and berry blends play an important part of an overall healthy diet. While millions of servings are consumed safely every day, they continue to be occasionally linked to hepatitis A (HAV) and norovirus outbreaks around the globe.

Investigation of a recent United States’ HAV outbreak, epidemiologically linked to frozen organic strawberries, has revealed complexities in assessing and determining the safety of frozen berry supply chains. These events have led to a recent call for HAV testing of finished products as a mandatory component by a retail food safety management program. We the authors describe the limitations of testing for HAV contamination in soft fruits, advise of the unintended consequences that could hinder more meaningful progress, and offer some alternative food safety management suggestions.

Limitations of the Enteric Virus test method
An important difference between testing for bacteria (e.g., Salmonella or L. monocytogenes) vs. viral pathogens in foods is that the viruses do not reproduce outside their host. This means culture enrichment is impossible, so testing protocols must rely on concentrating the virus from the food sample, followed by nucleic acid (RNA) extraction, and then detection of the virus genome using RT-qPCR. While this three-step method is currently the best approach available, it has inherent flaws. RT-qPCR detection limits tend to be higher than what we see for bacteria because of poor virus extraction efficiency and the presence of residual matrix-associated inhibitors. RT-qPCR is designed to detect only a small fragment of the viral genome. Since nucleic acids can be environmentally stable, detectable long after viruses are no longer infectious, a positive PCR result does not necessarily correspond to the presence of an intact and infectious viral particle. In short, a PCR positive cannot be automatically construed as an indication that the product contains infectious virus and constitutes a public health risk.

Limitations of sample size and sampling plans
HAV enters the berry supply chain through infected individuals, often via poor water and waste management systems. Unfortunately, the ultimate source of contamination is rarely identified through traceback, and the nature of any contamination event can vary widely from highly focal to much more diffuse. In many instances, HAV would be expected to be distributed in a non-uniform manner throughout a given lot of food. The table below was extracted from a simplified modeling exercise intended to investigate the likelihood of detecting HAV under different contamination scenarios¹. 

The analysis shows that the probability of detection is higher under what one might call a “gross” contamination event in which the entire production lot is contaminated. Note that this result is very dependent on the assumed concentration. If this assumed concentration is at or below the limit of detection for the test, even this contamination may not be detected.

Also, note that the likelihood of detection is always quite low when the contaminant enters the food through more focal events like poor personal hygiene of a hand harvester. Both concentration and prevalence of virus contamination drive the likelihood of detection. Detection probability can be improved by using bigger samples or testing more samples. Since sample size is fixed (e.g., 25 g for the ISO 15216-2 method), and virus testing costs usually exceed $150/sample, there is little opportunity for improving the utility of testing. In summary, sampling considerations, such as lack of statistical power, provide an additional hurdle to the value of screening finished products for HAV contamination. 

Table 1. Synopsis (best and worst case scenarios) of modeling exercise to investigate the likelihood of detecting HAV under different contamination scenarios with different numbers of samples (1 to 5) per lot tested using ISO 15216-2.

* This analysis relied on a number of assumptions: Virus may be present in some or all of a lot, and in different concentrations as detailed below; one virus particle is equivalent to one genome copy; when less than 1 virus particle is present in the ISO analytical unit of 1.25 g, the virus is present a fraction of the time (e.g., 0.1 virus particles per 1.25 g means the virus is present 10 percent of the time); This analysis also assumes that virus concentrations below the LOD₅₀ lower bound will always detected if present. This means that the high probability of detection from the raw sewage scenario may significantly over-estimate effectiveness.

** This high probability of detection is very sensitive to whether the virus concentration is above or below the assay limit of detection (LoD). If below the LoD, this probability is considerably lower.

Relationship between positive test result and public health risk
Taken alone, the RT-qPCR detection assay is highly sensitive, with a theoretical detection limit of one single target template molecule. However, this method has no reliable means by which to determine if that target template (1) comes from an infectious virus that can make someone sick; or (2) is just stray viral nucleic acid material or is associated with a non-infectious particle. In the first instance, there is a clear risk to public health; in the latter, essentially no risk. Until methods are available to determine whether a positive result is indicative of the presence of infectious virus (methods that are likely a decade or more away), interpretation of a positive PCR test is ambiguous. Interestingly, the Food and Agriculture Organization of the World Health Organization (FAO-WHO) has initiated a project to quantify the public health risk associated with potential enteric virus contamination in foods. Until an exercise like this is completed, the public health implications of testing and finding nucleic acid of HAV in frozen berries via random testing (especially when its concentration is very low), and without corresponding epidemiologically-linked illnesses is unclear. 

Where to go from here – addressing research gaps and a focus on prevention
The discussion above illustrates the myriad issues associated with detection of any non-cultivable foodborne pathogen in complex sample matrices. While testing is an important tool in the food safety toolbox, at the current time, there remain many research gaps that need to be answered to determine how to best use testing as a validation or verification tool. For example, could testing be used in a more focused and strategic manner as part of a risk assessment to determine potential sources of contamination such as irrigation water or wellness of a crew through testing portable toilet waste? Because HAV is so resistant to inactivation and disinfection, preventing contamination should be the top priority. Vaccination of food workers in direct contact with product along the supply chain is one means of minimizing the potential for contamination. While vaccination is expensive, so is testing, and a cost benefit analysis of farm crew vaccination should also be considered. A laser focus on personal hygiene practices of food handlers, Good Agricultural Practices, and proper water and waste management will all reduce the chance of an HAV contamination event and remain the current primary defenses for virus control in the berry supply chain. 

In summary, while tens of millions of fresh and frozen berries are consumed safely every day, unfortunately, berries are still occasionally implicated in HAV outbreaks and there is more the industry and regulators can do. Therefore, it is our view that an over-focus or reliance on end-product testing, using current vetted methods and low powered sampling plans, while well intentioned, could actually provide a false sense of security and hinder more meaningful and needed progress to further strengthen the safety of these important and nutritious products.

 Authors: Dr. Lee-Ann Jaykus, William Neal Reynolds Distinguished Professor, NC State University; Dr. Donald Schaffner, Graduate Program Director, Distinguished Professor and Extension Specialist, Rutgers University; Frank Yiannas, Former Deputy Commissioner, Food Policy and Response, U.S. Food and Drug Administration; Dr. Sanjay Gummalla, Senior Vice President of Scientific Affairs, American Frozen Food Institute

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Editor’s note: This is part of a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

You hear them say, “Oh my God, I love it so much,” with happiness in their voice, a smile on their face, eagerness in their demeanor, and love in their eyes. You’ll be curious find out the object of their affection. If you look closely, you might be dismayed to see that it’s simply a tomato fruit. In fact, the U.S. Supreme Court ruled more than 125 years ago that a tomato is a vegetable rather than a fruit for the purposes of tariffs, imports, and customs, but I digress.

The southern region of the United States is known for its warm welcomes, politeness that isn’t pretentious, and genuine helpfulness. Strangers are made to feel welcome in a Southern house by the practice known as southern hospitality.

Corporate America has discovered a way to use Southern hospitality as a weapon that makes customers feel welcome in corporate spaces. Shops feel like home for customers. When they enter any place of business, American customers have come to expect to be welcomed like guests in a Southern house.

“For all its ups and downs, Walmart is no doubt a genuine American institution.”
“In our culture, we have excessively high expectations,” Robin Kowalski, a psychology professor at Business School told Vox in an interview.

“The way we evaluate things is a function of expectations…If we’re used to a level of customer service, which Americans are, and then things change, like prices go up or things slow down, the violation of that expectation is what causes disappointment, anger, all of these sorts of things,” Deborah Small, a marketing professor of psychology at Wharton was quoted in the same Vox interviewer.

Meeting expectation of consumers is the vehicle on which businesses and to a large extend the American society run. “Consumer society, in fact, is not just about the satisfaction of needs, but in many ways, it is about the forms through which we view the world and our position within it … The arrival of consumer society during the last one hundred years has transformed not only our material existence but also our ontology, our very being itself.”

Walmart became the largest retailer in the world by perfecting meeting the needs of the American consumer.

Walmart’s genuine Americanness, however, was the cause of its failure in Germany. One of the American practices was requiring sale clerks to smile at customers. In Germany, customers interpreted the smiling to be flirting. “People found these things strange; Germans just don’t behave that way,” said Hans-Martin Poschmann, the secretary of the Walmart employees’ union told the New York Times in 2006, when Walmart pulled out of Germany after almost a decade of failing to make profit in the market. People do not expect their business to have a personal touch to it in Germany and as the New York Times pointed out, in other countries.

The Arkansas native-founded Walmart is not the only company that perfected the art of adding a personal touch to doing business. Georgia-based Delta Airlines, for example, touted its personal touch as a show of their Southern hospitality.

“Delta garnered the reputation for being a service-oriented southern airline with all the graciousness the Southern Hospitality is an expression that has historically been used to refer to the graciousness and civility that is associated with people from the southern part of the United States.

“It is no exaggeration to say that we are among the nicest people you are likely to meet,” Writer Florence King is quoted to have said.

“The most common qualities of southern hospitality include politeness, charm, kindness, helpfulness, and charity. These qualities are seen as aligning with the idea of what it means to be a good host.”

Southern Hospitality is often on full display at the Fayetteville Downtown Square every Saturday since 1974 when a city ordinance designated that space to be used as the Fayetteville Farmer’s Market. The setting at the market is relaxed, pleasant, inviting, and welcoming. To make customers feel like friends, farmers extend a kind greeting to their booth, inquire about their personal life, and enthusiastically volunteer information about their personal lives.

The market’s small-town neighborhood atmosphere can occasionally conceal the reality that it is a business district governed by laws established by the Fayetteville City Council and different departments of the state of Arkansas.

The primary laws that govern the market are summarized in the Farmers’ Market Vendor Guide. The latest guided of the document was drafted by the Arkansas Department of Health and Arkansas Department of Agriculture in September 2021.

The Guide quotes Arkansas State Act 1040 of 2021, allowing the sale of Non Time/Temperature Control for Safety (Non-TCS) Foods directly to consumers.

Non-TCS Foods was defined as “food that does not require time or temperature control for safety to limit pathogenic microorganism growth or toxin production and as defined in the rules of the Department of Health.”

“Uncut fresh fruits and vegetables” were explicitly named to fall under the non-TCS foods. The Guide named Ready-to-eat foods as food, which are covered under the non-TCS foods.

“Any ready–to-eat food that is prepared on site or any food that is provided to the consumer in a non- prepackaged form can only be sold or served from an ADH permitted and inspected facility. Any establishment preparing, selling, or serving any of these food items must fully comply with the Arkansas Department of Health’s Rules and Regulations.”

A tomato is a non-TCS food, however, a cut tomato may be considered a ready-to-eat food. And there lies the issue.

“The intention of the regulations that do exist is to mitigate the risk of foodborne illness. Any time a food is “processed” the risk for pathogens to contaminate the food is increased. As such the rules allow a vendor to offer an uncut cherry tomato as a sample, or a small muffin, but if the vendor has to cut the product in order to offer a sample (like slice a tomato or slice bread) it must be either pre-prepared in a commercial ADH inspected kitchen, or the vendor must have appropriate prep means at the market, that have been inspected and approved by an ADH Health inspector (similar to the requirements for businesses like Food Trucks or our sellers who prepare drinks like coffee at market)”, Julia Den Herder, one of the managers of the Fayetteville Farmers’ Market and a vendor herself, explains the distinction in an email.

A tomato fruit (or vegetable) is a non-TCS food but when it is cut and offered to the consumer, it is considered a ready-to-eat food which will require the permission of the Arkansas Department of Health to be sold on the market.

The American consumer, who is accustomed to getting what they want, purchases tomatoes for their appearance, texture, flavor, and aroma. The consumer can evaluate the tomato’s appearance and texture fairly with an uncut tomato (just by touching it). It provides no indication of its taste. Before making a final decision, the customer wants to taste the fruit. Although the tomato cannot be taste- tested if the customer purchases it from a Walmart, the Fayetteville Market’s relaxed attitude leads the customer to believe that this is exempted from the grocery store’s guidelines that Walmart is governed by.

The seller informs the customer that “the market does not permit us to offer samples to consumers” in order to please the customer while upholding the graciousness associated with Southern Hospitality. The supplier gives the customer a better deal. “I will offer you a sample in secret,” he says. “Come inside my booth so I may cut it for you in private.” The customer accepts the sample based on the seller’s claim after believing both claims provided by the vendor. The vendor has thus misrepresented the rules on sampling to the customer, in their bid to be polite.

“The market does not have policies that make it illegal to offer samples to buyers; however, sampling food products is regulated by ADH and RMPE rules about offering samples are in compliance with those regulations. Some of these rules are consistent with grocery store requirements for food sampling (like needing a three compartment sink for appropriate sanitation) and some are specific to Farmers Markets due to the nature of markets being distinct from other retail environments”, Julia Den Herder clarified.

The vendor has thus opened himself up to legal issues by the “innocent of politeness” that the “market does not allow us to offer samples.” Under Arkansas law, fraudulent inducement to contract (making a sale being a contract) is considered both a criminal offense and a ground for voiding a contract. The Arkansas Supreme Court explained the effect of fraudulent inducement in Wal-Mart Stores v. Coughlin.

Each situation in a food safety lawsuit has a slightly different liability. Some of it directly affects the market, and some of it affects the vendor. For instance, the Arkansas Department of Health will decide who is responsible in cases of food poisoning after looking into the source of the infection; if the vendor is discovered to be the pathogen’s original source, they will be held accountable. The market will find it simpler to hold the vendor entirely responsible if there has been misrepresentation.

Even though southern hospitality is generally excellent, it is not an acceptable alternative to a direct, firm response to a request, whether the response is a yes or a no.

About the author: Anthony Owura-Akuaku is a Former Paralegal, 1st Law Legal Practitioners/Consultants and Former Communications Assistant to the President, Musicians Union of Ghana LL.B., Central University Secondary School Certificate, Business, St. Peter’s Boys’ Senior Secondary School.

Editor’s note: This is part of a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

By Brittany Rowe

On March 29, 2023, the Center for Food Safety filed a lawsuit against Wood Farms in the U. S. District Court for the Northern District of New York for violating the Clean Water Act for polluting the St. Lawrence River. The lawsuit alleges that Wood Farms, a mega-dairy located in Clayton, New York that confines over 2,200 cows, has repeatedly discharged pollutants including solid manure and liquid manure, process wastewater, and related operational waste products, into waters of the United States in violation of its clean water permit for a period of five years and sixty days. Plaintiff seeks declaratory relief, injunctive relief, and civil penalties. 

Plaintiff Center for Food Safety is a nonprofit public interest and environmental advocacy organization with over 830,000 members nationwide whose mission is to “empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture.” The Center for Food Safety brought this civil action against Wood Farms pursuant to the citizen suit provision of the Clean Water Act . The Clean Water Act requires facilities that intend to discharge pollutants into navigable waters obtain a National Pollutant Discharge Elimination System (NPDES) permit. One such facility that requires an NPDES permit is a concentrated animal feeding operation, or CAFO. A large CAFO is defined as an animal feeding operation where “animals (other than aquatic animals) have been, are or will be stabled or confined and fed or maintained for a total of 45 days or more in any 12-month period, and . . . crops, vegetation, forage growth, or post-harvest residues are not sustained in the normal growing season over any portion of the lot or facility” and confines a specific number of animals set out under 40 CFR § 122.23(b)(4). Wood Dairy Farm falls under the definition of a large CAFO because it has over 700 mature dairy cows. Once a facility is regulated by a NPDES permit, the facility must comply with all terms and conditions of the permit. If a facility fails to comply with the permit, the Clean Water Act permits citizens to file suit for violation of the Act. 

Wood Farms generates solid and liquid manure which it stores in lagoons, which the complaint alleges leak into the soil and discharge into the St. Lawrence River and associated tributaries, including Wheeler Creek, Lake Ontario, Kents Creek, Mud Bay, and adjacent tributaries, ditches, and wetlands (Wood Farms Discharge Waters) and load onto trucks for land application. The complaint alleges that Wood Farms has discharged pollutants in violation of the Clean Water Act in several ways. First, Wood Farms has discharged wastewater into surface waters of the State, which are excluded from coverage under its NPDES permit. Second, Wood Farms has discharged manure to surface waters of the State, which violates its NPDES permit. Third, Wood Farms has discharged “manure or process wastewater in saturated conditions including applications made on saturated soil (either fluid-saturated or frozen-saturated soil conditions) or applications made at a rate that creates or causes the soil to become saturated a the time of that application,” which violates its NPDES permit. Fourth, Wood Farms has discharged manure or process wastewater to land application areas during winter months in a way that does not conform with the 2015 Cornell Guide or NRCS NY590 Standard, a nonconformity that violate its NPDES permit. The pollutants contained in the discharged liquid and solid animal wastes include fecal coliform and E. coli, other pathogens, nitrogen, phosphorus, and suspended solids. These pollutants harm water quality and pose a public health risk for people who use the Wood Farms Discharge Waters and degrade the surrounding environment. 

The complaint includes photographs taken in January 2023 at Wheeler Creek near where it joins the St. Lawrence River that show significant foam formation from phosphorus and other pollutants Plaintiffs allege came from Wood Farms’ manure or process water discharges. Similar photographs were taken in February 2019 and March 2014. Wood Farms was cited back in 2014 for violations related to an unpermitted overflow pipe and again in 2008 for process wastewater from Wood Farms to Wheeler Creek. Thus, the complaint claims 1) Wood Farms discharged pollutants in violation of its NPDES permit, and 2) Wood Farms failed to comply with the reporting requirements of its NPDES permit, both of which violate the Clean Water Act.   

Mega-dairies, large-scale commercial dairy operations that are a type of CAFO, generate large quantities of manure that carry nutrients and pathogens, leading to water pollution and public health risks. CAFOs are a leading source of water pollution and a point source that requires a permit under the Clean Water Act. Historically, however, only a small percentage of CAFOs are regulated and the Clean Water Act permits fail to adequately protect waterways from the pollution generated by CAFOs. 

This case is part of a larger effort by nonprofit public interest organizations to hold CAFOs accountable for the pollution they create and close loopholes that allow CAFOs to skirt accountability. In January, the EPA responded to a 2021 Food and Water Watch lawsuit that urged the EPA to scrutinize water pollution stemming from CAFOs. The EPA announced that it would undertake several new studies to collect and analyze data on factory farm water pollution to determine what steps it needs to take to strengthen the Clean Water Act. Specifically, the EPA intends to “undertake a detailed study of the Concentrated Animal Feeding Operations (CAFOs) Category (40 CFR part 412), which will focus on collecting further information to enable the Agency to make an informed, reasoned decision on whether to undertaking rulemaking to revise the ELG for CAFOs.” This is the first time in fifteen years that the EPA will revisit the regulation of water pollution from factory farms. 

Soon after the Wood Farms case was filed, the EPA came to an agreement with the Center for Food Safety, Food & Water Watch, and nine other organizations related to the Agency’s unreasonable delay in responding to a 2017 petition to overhaul water pollution regulation for CAFOs. The petition recommendations included: 1) revising the agricultural stormwater exemption; 2) establishing a presumption that CAFOs cause pollution and require them to obtain permits; 3) improving discharge monitoring; 4) prohibiting practices that harm water quality; and 5) strengthening effluent limitation guidelines. After the EPA failed to respond to the petition, Food & Water Watch filed a lawsuit in the Ninth Circuit Court of Appeals in October 2022. In April 2023, the EPA agreed to answer the petition by August 15, 2023, which could lead to tighter water pollution standards for CAFOs in the United States.

About the author: Brittany Rowe is former Judicial Pool Clerk, Lane County Circuit Court, Oregon; J.D., Lewis and Clark Law School, Animal Law Certificate; Co-Editor in Chief, Animal Law Review; Author, 2020 Foreign and International Legislative Review, 27 ANIMAL L. REV. 175 (2021); B.S., Sociology and Anthropology, West Virginia University.

Editor’s note: This is the first in a series of papers written by students in the Food Safety Litigation class taught by Professors Bill Marler and Denis Stearns in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law.

By John Mulcahy

“We have met the enemy and he is us.” -Walt Kelly

It has been over thirty years since the West Coast fast food chain, Jack in the Box, found itself embroiled in litigation over an E. coli outbreak that stemmed from undercooked hamburger patties sold in several of its locations.  Sickening, maiming, and killing children in several Western States, the insidious nature of the outbreak proved to be a watershed moment in food safety.  From lawyers and doctors to government officials and c-suite executives, interested parties vowed to improve food safety.  Jack in the Box, then the sixth largest fast-food chain in the United States, exerted pressure on its suppliers, Congress held hearings, and lawyers brought actions, all in an effort to ensure that the devastation that resulted from the outbreak would not be replicated.    

Since the resolution of the last remnants of the litigation that stemmed from the Jack in the Box outbreak, advances in science and technology have proliferated at an unfathomable rate, all while the public commitment to ensuring a safe food supply has remained steadfast.  Because of this, it would be reasonable to assume that widespread outbreaks of foodborne illness no longer pose a health risk.  Yet, in the intervening three decades, the incidents of food borne illness in America have climbed year over year, with little exception.  And, with each new outbreak, comes a rash of litigation. 

The role that litigation plays in advancing society’s collective goal of ensuring a safe food supply is viewed differently by the various stakeholders.  Certainly, the victims of a foodborne illness outbreak maintain a favorable view of the lawyers who hold producers and purveyors to account through the justice system.  The governmental officials on whose watch the outbreaks occurred and the companies that failed to protect consumers, however, do not hold the lawyers or their tactics in the same regard.  In their eyes, the lawyers are profiteering off of tragedy, advancing their own pecuniary goals under the guise of altruistic service.  The retort from the legal community is simple and direct: if you don’t want further litigation and the criticism that comes with it, deliver a safe product to consumers.  This message, though, is delivered with a wry smile from the litigators filing the lawsuits on behalf of the sick and injured because they know, as we all do, that no degree of care can eliminate the proliferation of foodborne illnesses.  

While goods can be manufactured to the strictest specifications and subjected to multiple, often computerized, quality control regimes, it is impossible to remove the human element from the food chain.  And, whenever safety depends on the vigilance of everyday people, it is not possible to maintain a perfect track record.  This is illustrated by certain aspects of two foodborne illness outbreaks that occurred decades apart, the Jack in the Box E. coli outbreak of 1993 and the Chipotle norovirus outbreaks of 2015.  In both outbreaks, the human factor was dispositive, but not necessarily in the way one would expect.    

On its face, the many failures that caused the Jack in the Box E. coli outbreak seem apparent.  Jack in the Box purchased meat that contained E. coli and then failed to cook the meat to the temperature required by the State of Washington.  If the meat had been cooked to the required temperature, the E. coli would have been killed and the outbreak would not have occurred.  From the management of the meat processing plants, to the State of Washington health officials, to the Jack in the Box corporate officers, the number of people who, if they had done their jobs properly, could have stopped the outbreak are many.  Their failings, though, are outsized and would lead one to believe their ineptitude could be remediated to ensure that an outbreak of that nature would never happen again.  But, remember, perfection is not possible and there was another less apparent aspect of Jack in the Box’s operations that, in essence, caused the outbreak.  

While many of the Jack in the Box restaurants received the tainted meat, only the patrons of some of the restaurants were sickened.  Like most fast-food restaurant chains, the meat was cooked for the same amount of time, at the same temperature and in the same manner at each Jack in the Box restaurant.  It was anomalous that the exact same conditions could result in such wildly different results.  While it is true that the meat was cooked exactly the same way in each restaurant, the age of the grills the meat was cooked on varied from restaurant to restaurant.  The newer grills held their temperature, and the older grills did not.  It was fortuitous that Jack in the Box failed to adopt the State of Washington’s requirement that all meat be cooked to 155 degrees.  The E. coli was killed at Jack in the Box’s standardized cooking temperature of 140 degrees, which was achieved at each restaurant that utilized the newer grills.  Stripping the Jack in the Box outbreak down to its simplest form reveals that had Jack in the Box properly calibrated its grills, the outbreak would not have occurred.  The ineptitude of the meat processors, the health inspectors and the executives at Jack in the Box would have been rendered moot had someone confirmed the grills actually reached their set temperature.  Food safety requires an unbroken chain of perfection.  If any link is broken, ensuring an outbreak does not occur is impossible.

 The Department of Justice’s press release from 2020 was, in part, succinct, “Chipotle failed to ensure that its employees both understood and complied with its food safety protocols, resulting in hundreds of customers across the country getting sick.” One of the sicknesses referred to in the press release was norovirus, a highly contagious pathogen that can cause diarrhea and vomiting.  Unlike Jack in the Box where a bacterium in the food being served caused the outbreak, the food that was being served by Chipotle was safe, it was workers serving the food that were not.  In separate instances in California and Massachusetts, hundreds of Chipotle customers were sickened when a single employee in each of the restaurants came to work ill.  In 2015, the year of the norovirus outbreaks, Chipotle had nearly 60,000 employees, representing 60,000 links in the food safety chain.  It took the actions of two such employees to break the chain and affect the lives of hundreds of people.  

When the food safety record of a multi-national company that employs thousands of workers comes down to the actions of a single employee, the scale of the monumental challenge of ensuring food safety comes into focus.  Today, Chipotle employs nearly 100,000 people and it is self-evident that it would be impossible to ensure that each individual follows all of the company’s food safety protocols.  In fact, the only action that has resulted in a reduction in the incidents of food borne illness in the last several decades, was the wholesale closure of restaurants during coronavirus pandemic.  According to FoodNet, incidents of food borne illness decreased in both 2020 and 2021.  While there is some debate as to whether other factors contributed to these reductions, such as a lack of access to in-person medical care or testing, given the sheer number of outbreaks that originate from restaurants, it is reasonable to assume that at least some of the amelioration of foodborne illness during this time was due to the remedial measures put in place to combat the pandemic.  The multi-year reductions illustrate that the only completely safe restaurant is a closed restaurant.   

According to the U.S. Bureau of Labor Statistics, in 2022, the last reporting year, millions of Americans worked in the food service industry.  Which means, on any given day, there is an infinite number of opportunities for human transgression.  Whether it is a Jack in the Box employee who fails to calibrate a grill or a Chipotle employee who comes to work symptomatic, it is not possible to hedge every apparent or obscure risk.  And, when one error has the potential to result in widespread sickness, it is no surprise that it has proven to be impossible over time to curtail the incidents of food borne illness.  As long as Americans are eating, the outbreaks will continue and, like it or not, so too will the litigation. 

About the author: John Mulcahy of Connecticut, is Vice President, Shareholder, & Director, Updike, Kelly & Spellacy, P.C. He is J.D., Quinnipiac University School of Law Merit Scholar. Quinnipiac Law Review M.S., summa cum laude, Political Science, Southern Connecticut State University B.S., Political Science, Southern Connecticut State University.

By Wendelyn Jones, PhD

According the United Nations Industrial Development Organization Corporate Social Responsibility is a management concept whereby companies integrate social and environmental concerns into their business  operations and stakeholder interactions. 

At IAFNS, we believe that food safety efforts — which can often be thankless tasks – should count in CSR tallies at companies. CSR is generally understood as the way through which a company achieves a balance of economic, environmental and social imperatives — the “Triple Bottom-Line Approach.” CSR can take many forms, from community volunteering to support of local charities to company programs and projects with a national scope. But food safety is a global good that companies should be proud of. 

In the food and beverage space, for example, IAFNS members track the safety of sodium and caffeine as part of ongoing initiatives. Producing food means companies take responsibility for food safety and other “public goods” from their supply chain to the consumer.

But let’s split “responsibility” into its constituent parts. The term “responsibility” implies obligation, and while there is a strong element of that in CSR, thinking of it in terms of “response-ability” is closer to what IAFNS endeavors to deliver in the food safety space. 

For example, foods like pistachios, chocolate and cereal are generally considered ready-to-eat, low-moisture food (LMFs) products. Some foodborne viral outbreaks associated with LMFs have been reported in recent years. IAFNS invested in understanding pathogens in low-moisture foods, giving firms and other organizations in the food sector the response-ability to change their food processing and storage protocols to address any residual pathogen risks. As foodborne pathogens can persist for some time, IAFNS-supported researchers found that a method called Advanced Oxidative Process treatment worked optimally as an inactivator.

Another example involves IAFNS-supported studies of protein in the diet. A recent analysis found that increasing protein intake while dieting leads to improved intake of green vegetables and healthier diets. Increasing dietary protein during caloric restriction improved diet quality and helped to maintain Lean Body Mass in the study. This particular paper has been cited in multiple media stories including the San Francisco Gate and Yahoo! News and gives both company formulators and interested consumers the response-ability to update their practices.

Finally, sodium consumption has been covered by Food Safety News previously. An IAFNS-supported study extracted analytical methods, broad and specific reduction categories, significant outcomes, and other strategies for decreasing sodium. Methods included salt removal, salt replacement, flavor modification, functional modification, or physical modification. Although salt removal and salt replacement were the main strategies, future public health improvement efforts may benefit from combining methods focused on the food supply. In addition, it’s important to look at sensory characteristics, technology and consumer perceptions. IAFNS response-ability in this area includes a searchable database of papers on options for salt reduction techniques for adoption in the food sector. Watch this space for our database of sodium reduction papers and other tools as they become available.

In this way, scientific research on food safety contributes to and shapes CSR. Research efforts empower companies, cooks and consumers to make key choices as a result of new knowledge which IAFNS helps generate. This response-ability provides new, well-informed options for those in the food and beverage ecosystem to optimize their food safety choices, reduce risks and interact constructively with their stakeholders.

About the author: Wendelyn Jones is Executive Director of the Institute for the Advancement of Food and Nutrition Sciences (IAFNS). She has a passion for bringing together science and society, drawing from her global experiences working across chemical, agricultural, food, and health sectors. She applies her PhD in life sciences to extend IAFNS’ contribution to, and impact within, diverse scientific and health communities.

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The Summit offers a dynamic conference program featuring speakers from leading manufacturers, growers, non-governmental and government agencies, trade associations, supermarkets, academic and legal professionals who will cover all of the important topics facing the industry. 

The event kicks off on Monday, May 8^th with four Certificate Courses including NEHA’s Certified Professional–Food Safety (CP-FS) Credential Review Course, Food Fraud Prevention Workshop and Certificate Course, The HACCP Alliance’s Hazard Analysis and Critical Control Point (HACCP) Certificate Training, and FSMA FSPCA Foreign Supplier Verification Program.

On Tuesday, May 9 there will be five half-day workshops, addressing the following: Got Root Cause; Developing Food Safety Leadership Skills – Building the Workforce of Tomorrow; Recent Advancements in Sanitation for the Prevention and Control of Food Safety Hazards; AI, Data Gathering, and Analysis – What Are you Using AI For?; and Looking Forward and Looking Back: How Companies can Establish a Robust and Compliant Traceability Program

The keynote presentation on Risk Culture: How to Balance Risks for the Safety of Consumers, Team Members, and the Environment will feature Michael Eckhardt, Senior Vice President, Chief Legal and Risk Officer, and Secretary, Wawa Inc.; Randy Huffman, Ph.D, Chief Food Safety and Sustainability Officer, Maple Leaf Foods; and David McDonald, President and Chief Operating Officer, OSI Group will join Lone Jespersen, Ph.D., Principal, Cultivate SA, who will lead this important conversation.

The 11th annual Town Hall: A Conversation with Top Regulators and Advisors will be held on Thursday, May 11, with insights from Donald A. Prater, D.V.M. U.S. Food and Drug Administration; Sandra Eskin, U.S. Department of Agriculture; Steven Mandernach, Association of Food and Drug Officials and Robert Tauxe, M.D., M.P.H., Centers for Disease Control and Prevention. The Town Hall will be moderated by Gillian Kelleher, CEO of Kelleher Consultants and Chair of the Food Safety Summit Educational Advisory Board.

The Summit’s closing session on Thursday afternoon will focus on Legal Insights to Sharpen Your Food Safety Focus—and Stay Out of the Courtroom. The panel discussion will feature prominent attorneys who work on behalf of consumers and industry—with all advocating on the side of food safety. These internationally recognized expert lawyers will discuss the common gaps or weaknesses they see in company operations, culture, and regulatory adherence that lead to adverse events, such as foodborne illness outbreaks and recalls. 

On Wednesday and Thursday there will be eighteeneducation sessions on such timely topics as Pathogen Genomics, Outbreak Investigation, Cold Chain Management, Salmonella in Poultry, The Supply Chain, Cannabis in Food, PFAS in Packaging, Food Safety Culture, Reducing Food Loss and Legal Insights.

The Exhibit Hall will feature over 200 solution providers showcasing the latest products and services for food safety professionals including Gold Sponsor Purell; Silver Sponsor InstantRecall, and Bronze Sponsors Crunchtime and RedZone. There will be educational opportunities on the show floor in the Solutions Stage and Tech Tent with presentations on advanced technology solutions offered throughout the three-day event.    The Community Hub, in the center of the floor, will give attendees a chance to gather, network and listen to several Food Safety Magazine podcast interviews with leaders in the industry. New to the Hub this year is our Podcast Theater, where attendees can have a seat and listen in on interviews with distinguished Summit speakers including top regulatory officials, industry leaders, and academic experts.

The opening night reception will be held on the trade show floor and offer food and drinks for a casual setting for our attendees and exhibitors to mingle and network.  On Wednesday night we will host the Food Safety Summit Gives Back. This is an opportunity for Summit attendees, exhibitors and sponsors to give back to the community. This year we are supporting Stop Foodborne Illness and the wonderful work they have been doing for 30 years.  The money donated goes to support the organization’s vision of “A World Without Foodborne Illness” and their mission to be the voice of people affected by foodborne illness”, by collaborating with partners in academia, the food industry, and government to prevent foodborne illness.  Stop advocates for effective food safety policy and facilitates culture change to increase food safety.

Registration is open at https://www.food-safety.com/food-safety-summit. There are 1-, 2- and 3-day conference packages available and group discounts. A conference pass provides access to the interactive half day workshops, 27 in-depth education sessions, , the keynote and Town Hall presentations, lunch in the exhibit hall, two networking receptions, access to 200+ solution providers, free education in the Solutions Stage and Tech Tent, and NEHA continuing education credits.  

The Food Safety Summit is owned and produced by BNP Media (www.bnpmedia.com), one of the country’s leading business-to-business media companies serving industry professionals across 60+ industries through magazines, custom media, e-newsletters, webinars, events, and market research.

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For the complete study with corresponding tables and graphs, please click here.

ABSTRACT

Foodborne Illness variables can be broken down into 3 major categories controllable through policy intervention: 1) Risk Factors; 2) Inspection (including standardization of inspections); and 3) Food Laws. Finding the right combination of interventions to help minimize the risk of illness is important in public policy for the reduction of foodborne illness.

The Food and Drug Administration assigned risk factors used in the current Retail Food Code, which inspectors mark in reports to identify trends in license holder’s food safety performance. The assignment of value to each item/observation marked has changed through different food codes, some moving from ‘critical’ items subsequently downgraded to ‘core’ (low level) observations. This poses the questions “is the assignment of value placed upon items a true representation of the potential risk and prevention of foodborne illness especially when risk levels change with state and local laws?”; “Does the FDA recommended frequency of inspection per risk level of establishment result in a reduction of foodborne illness events, and are the levels achievable with the available resources?”; “ Do risk factors and frequency of inspection function independently or in unison as a deterrent to foodborne illness?”

FDA established risk levels to facilities as a means for retail food agencies to assign sparse resources in a manner that best utilizes those resources for inspection and provide a recommended frequency of inspection for facilities based upon risk; however, is providing accommodations to do ‘the best with what agencies have’ enough to ensure the safety of retail foods for public consumption? Industry wants less reporting on publicly available inspection reports, the public wants to know inspection report scores placing politicians in a position of keeping both segments of their constituency happy while maintaining economic stability. Is it feasible to keep everyone satisfied and protected? What impact does frequency of inspection, risk factors, and change in food law have in foodborne illness if any?

This study builds upon previous studies to add to the empirical literature for food safety interventions. Reviewing studies on regulatory inspections, recalls, and food laws can provide insight to legislators for viable solutions to our food safety system. By examining the relationship related to food safety laws, foodborne illness risk factors, and frequency of inspection over a three-year period or longer the intent of this study is to identify individual variables that when collectively analyzed will provide a broader picture for plausible policy change corresponding to the reduction of foodborne illness events.

SYNOPSIS OF STUDY

The study Inspection, Laws, Risk Factors, & Foodborne Illness is designed to examine variables that might contribute to the control of foodborne illness in the Retail Food Program – the one section of the food safety system that notably is not federalized and lacks formal federal jurisdiction. The FDA Model Food Code is voluntary with many versions in use across the country – sometimes within the same state. 

The questions posed in this study are on the frequency of inspection and change in food code laws, subsequent effect of risk factors levels observed during regulatory inspections of retail food establishments, and any affect foodborne illness:  

•     Is there a correlation between frequency of inspection and foodborne illness? 

•     Is there a correlation in changes of risk factors as laws change? 

•     Does a change in food code/law correlate to risk factor changes/ foodborne illness changes independently or in conjunction with frequency of inspection?   

 An important question that must be answered is how the current regulatory system can uphold its responsibility to the public enforcing the law and food safety without adequate funding, with an increasing number of food establishments, and insufficient numbers of food inspectors. With the budget constraints for regulatory agencies and pandemic of foodborne illness, the U.S. needs to re-evaluate what policies will lead to better outcomes for consumer protection.

This study adds to the empirical literature on foodborne illness by examining the relationship between frequency of inspection, changes in food law, risk factors, and foodborne illness events in the Retail Food Programs in the three comparable metropolitan areas of Atlanta (Fulton County), Boston, and San Francisco. 

Food Study Framework

Looking at past studies helps to understand the foundation on which this current study is built. Many diligent researchers have compiled data, which this study and others add to in the hopes of finding plausible solutions to improve our food safety system and reduce foodborne illness. 

Understanding the inherent strengths and weaknesses of the United States food safety model, it is easier to conceptualize the cause of gaps in food safety structure, oversight, and funding that permit adulterated foods to enter commerce and cause foodborne illness events at various stages in the food supply chain from the farms to the retail segment. Because of the variables associated with foodborne illness outbreaks past studies have examined different variables to look for correlation between specific variables and foodborne illness. Few have examined the relationship between frequency of inspection as a metric and none have examined the relationship between change in food law and risk factors.

Timothy Jones, Boris Pavlin, Bonnie LaFleur, Amanda Ingram, and William Schaffnert conducted a study in 2004, Restaurant Inspection Scores and Foodborne Disease using data from statewide restaurant inspection in Tennessee from January 1993 through April 2000 to determine if a causal relationship between inspection scores and foodborne illness existed. The report stated, “The limited data available on outbreaks in Tennessee suggests that restaurant inspection scores alone do not predict the likelihood of a foodborne outbreak occurring in a particular establishment” (Jones, 2004). “While the two most common critical violations (proper storage of toxic items and good hand washing and hygienic practices) were more likely to have been cited during the two routine inspections before an outbreak occurred at a restaurant, the number of reported outbreaks is small, and the conclusions that can be drawn from this observation are limited” (Jones, 2004). The authors suggested that further study be considered to determine if the frequency of inspection improved food safety.

A small, but important study in Washington State’s King County – A Study of Food Service Establishment Sanitation by Max Bader (1978) – examined the correlation between frequency of inspection and food safety. The study randomly selected establishment couples forming a control group and experimental group to measure the differences observed by sanitarians in the control group undergoing inspection four times a year excluding complaints and foodborne illness events and an experimental group undergoing inspection once annually with the same exclusions. The study noted a 47% higher demerit score in the experimental group with 15 foodborne illness complaints associated with the experimental group in comparison to the three complaints against the control group (Bader, 1978). While the study results are impressive, potential for bias existed in the study which was designed and conducted by the inspectors responsible for inspecting the same facilities in their district for the study. A broader sample of historical data in other regions would avoid a potential claim of this bias and could validate, add to the weight, and demonstrate the significance of the findings in the King County study. Furthermore, increased study on the frequency of inspection for wholesale and retail foods would be beneficial considering modern technologies and regulations in both segments not available in 1978.

A variable that is useful to measure the importance of regulatory inspection is the ability of FDA to remove adulterated food from commerce, by removing unsafe foods from the market foodborne illness is prevented. The USA commissioned a report in 2018 to determine if a causal relationship existed between recalls and frequency of inspection. Elina Tselepidakis Page authored a report summary from the Economic Research Service titled ‘Trends in Food Recalls: 2004-13’, in which an increase in recalls was attributed to an increase in inspection. Information collected from FDA and FSIS sources was charted and tabulated using the types of recalled Foods. Recalls were averaged from the first five years and the last five years and tested for significance according to the study (Page, 2018). “Several possible factors may explain the upswing in recalls, but conclusively stating a cause is difficult” (Page, 2018). Food expenditures increased annually by an average of 1.4 percent; however, the total number of recalls increased annually by 18 percent indicating other factors also contributed to the recalls (Page, 2018). The frequency of FDA inspection was indicated as being a possible variable. Analyzing the total number of FDA recall events against the total number of FDA inspections of domestic facilities from year to year suggested that inspections may be positively associated with recalls with results in a Pearson correlation coefficient of 0.5 (Page, 2018).   

The importance of inspection and recall is significant because removing unsafe foods will reduce outbreaks. With frequency of inspections association with improved inspection scores and increase in recall, it is prudent to examine this relationship further and any preventative mechanism impacting foodborne illness resulting from increased inspection. Also, USDA has the ability to meet its mandated frequency of inspection with its workforce, it is prudent to examine the benefit of increased frequency of inspection by FDA with an increase in field inspectors comparable to the ratio held by USDA. FDA is scheduled to do high-risk facilities at least once every five years; the Food Safety Inspectional Service (FSIS) does daily inspection. The ratio of FSIS inspectors to FDA inspectors is significantly higher annually, and they inspect facilities under their jurisdiction with a higher frequency than FDA. The Federal Food Safety System: A Primer written in 2014 and 2016 provide statistics gathered from government sources on the number of inspections conducted by USDA and FDA between the Fiscal Year 2004 -2015 (Johnson, 2014-16). The lack of field inspectors is prohibitive to FDA’s meeting its mandated inspection numbers under FSMA at this time and will continue to worsen without a meaningful change in the number of inspections or registered facilities. In compiling the data excluding foreign inspections and USDA and FDA state inspections, the FSIS has approximately 1.37 field inspectors per facility in comparison to FDA’s approximately .038 field inspectors per facility. This ratio is important to consider in the number of recalls and foodborne illness events under each jurisdiction and the ability of each agency to reduce risk of foodborne illness events. Underfunded and understaffed food safety agencies have been a historic problem in the United States making timely monitoring and enforcement of foods difficult and creating the reactive rather than proactive approach to food safety currently in place.

Study Design 

The study is based upon three comparable metropolitan areas as subject areas with retail food inspectional data spanning a period of three or more years examining the retail food segment of the United States food safety system. The metro areas were chosen because of the availability of data for the food inspections, the variations of food code laws during the span of years in the study, different approaches in retail food inspection, and frequency of inspection as required by each city’s laws governing retail food.  

The study uses inspections of facilities licensed over the specified time frames between 2014 and 2018 with food law differences in comparable metropolitan areas. 

•     Assigned Violation Risk Level’s per year are tallied in each subject metro area to determine the frequency of each item observation annually (per metro area) under the state assigned risk level. 

•     Coded Risk Factor Items per year in each subject metro area are tallied to determine the frequency of each item observation annually (per metro area) under a common coding system (using the FDA 44 item sheet numbering system) using Boston’s risk levels as the control to determine the pattern of item observations in each state and collectively in comparison to local assignment of risk factor levels. This will identify if laws affect risk factor assignment. 

•     The target sample in each of the three metropolitan areas are licensed retail food establishments serving non-prepackaged foods produced on site in all licensed full service and fast service food facilities only.  

•     Retail Food Facilities excluded from the study models are retail markets (grocery stores, supermarkets) because Georgia assigns inspection of these facilities to the DAG for retail food inspections. All other types of retail food service not open to the public are excluded. Hospitals, correctional facilities, schools, daycares, nursing homes, assisted living, private clubs, bars not serving food, religious facilities and events, mobile food service, kiosks and carts, camps, elderly care facilities, and temporary events are excluded. 

•     Unplanned routine inspections only are included in the study, excluded are complaints, follow ups, or other forms of inspections.  

Theoretical Framework: Correlation Relationship Studies 

Further study has been called for to build upon and expand the body of empirical works to understand the influence of variables in foodborne illness. Foodborne pathogens affect ingredients from the farm to the fork resulting in the need to look at controls for the various stages in the supply chain. Food is supposed to be free of adulterants (21 U.S. Code § 342);However, inherent pathogenic risks from the environment follow the product through the food chain. At the final stages in the supply chain prevention can minimize risk of outbreak by foods that have been contaminated from the source through some form of treatment (i.e., heat treatment, freezing, or chemical intervention) or by control through risk factors at the retail food level. Consumers’ shift in habits from eating food mostly at home to eating food prepared outside of the home or simply eating food at restaurants or hybrid retail establishments has corresponded to an increase in foodborne illness from the retail food sector (DeWaal & Dahl 1996) (Jones, Pavlin, LaFleur, Ingram, & Schaffner, 2004). 

FDA established risk factors to reduce the risks at the production side in the retail sector and accommodate for the lack of staffing in retail food inspectional programs (FDA, 2013 Annex 5, p. 588) and assigned different frequency of inspection based upon establishment risk categorization as classified by the FDA (for the purposes of this study as found in the 2013 Retail Food Code). Whether the illnesses are a result of primary source contamination or production contamination, risk factor controls should help to minimize foodborne illness. The shift in foodborne illness to the retail sector in restaurants has occurred prompting scholarly examination of factors for controlling foodborne illness. As outlined previously, different theoretical frameworks exist for examining food safety. The correlation relationship study is the chosen approach to look for interventions through food law assigned risk factors and frequency of inspection as the variables in food inspection that may reduce foodborne illness specific to retail food laws.  

Food law defines risk factors and risk levels of items. Reassignment of risk factor levels and values due to variance in state and local law may result in the misrepresentation of risk factor patterns that contribute to foodborne illness. Past studies that researched frequency of inspection are limited with varied results; also, past studies used single jurisdictions that would not naturally demonstrate a change in frequency of inspection time frames. Time frames ranged from a one-year period for data collection, with the longest a collection of three-years of data in a single jurisdiction.  

This study uses diverse populations in different geographic locations in multiple cities with different food laws over longer time frames. The broader sample size provides additional regional differences that might broaden the variable ranges for testing and analysis on possible effect of the chosen independent variables on foodborne illness. By reviewing the risk factors marked as violations with change in food law, the frequency of inspection, and incidence of foodborne illness reported between 2014 – 2018 in the subject cities respectively, it is possible to determine if a correlation between one or more variables exists. 

A consideration for the choice of subject cities is the development of food service inspection programs; inspector employment and training requirements; foodborne illness data in comparable metro areas; availability of access to data for retail food inspections in the subject cities, and the number of years of reporting for the available data. Analyzing inspection data and food code regulation versions from the subject city retail food laws using descriptive and inferential statistics this study examines the frequency of inspection in years with food code changes, the risk factors marked as violations in those timeframes (assigned and coded as applicable so all risk levels are equal) and reported incidence of confirmed foodborne illness. patterns of risk factors and items observed, the focus is not on assigning causation to any specific risk factor for foodborne illness events as in other studies but the change in risk factor level assignment as laws change and overall high-risk factor effect on foodborne illness. 

Different states use different versions of the food code during the same time period or a unique state food law (as in San Francisco) that complicate comparison of some inspectional data sets; therefore, coding is done to match violations under the same item number in all subject cities for comparison to the subject cities assigned risk levels by local retail food law and regulation. Using the Boston inspection form from 2018 (based on the historical Federal 44 Item Inspection Form) as the standard for coding observations it is possible to standardize the item numbering and risk factors, so all things are equal and identify differences in observation practices between the subject areas. In this manner it is possible to test for differences if any in risk factors posed by change in law. 

States may arbitrarily determine what retail food inspection data to collect and risk factors are not always captured as data. Retail food reports vary from state to state and may vary from county to county or town to town. Violation Items vary in reports in different jurisdictions; some retail food reports only hold values of “In” or “Out” of compliance, others include “Not Observed”, or “Not Applicable”; some states coded violations as “Blue” and “Red” violations for critical and non-critical items, others as ‘critical’ and ‘non-critical violations risk factors. Retail Food agencies may use a grading system in inspections either numerical or alphabet, some do not use either. Inspection forms vary in all the subject states as is typical across the country, even within states (as seen in California and Massachusetts).  

Reporting of foodborne illness complaints differ from city to city. San Francisco separates illness reports by confirmed Foodborne illness events where 3 or more people are confirmed ill from the same pathogenic organism (Terrence Wong Supervisor, personal correspondence, 2019). Other cities adhere to the CDC standard of 2 or more people with exception to members of the same household. CDC statistics for foodborne illness events are reviewed. A weakness in the CDC data is that it does not include all illnesses, only illnesses that are reported; also, it does not separate illnesses by cities or counties so subject city reporting from epidemiological departments is included in the study.

Rationale and Significance for the Study

Food can and does kill children, teens, adults, the elderly, and the immune compromised population in this country. The United States is currently experiencing an average of 22 foodborne illness events annually that cause illness and death to its citizens. No-one should have to become seriously ill or die because they consumed adulterated food. It is imperative we examine our food safety system to find solutions to reduce foodborne illness. This research will not be an end all solution, but rather a continuation in the ongoing effort to find solutions to improve food safety. 

Methodology  

The methodology is quantitative using descriptive and inferential statistics; the approach for the study is a comparative correlation/causal relationship study. The approach was chosen because of the availability of pre-existing inspection data capturing the risk factors from the multiple subject states/cities, frequency of inspection across years with changes in food code and reported foodborne illness during the same time frames for each subject state/city.  

Correlation/Causal Hypothesis  

By looking at correlation/causal relationship studies we can look at individual variables that when collectively analyzed can give a fuller picture of approaches for policy change that could beneficially impact food safety in the U.S. and correspond to the reduction of foodborne illness events. Looking at studies on regulatory inspections, food codes/laws, and recalls provides insight to legislators on plausible solutions for our fractured and ineffective food safety system in the U.S. that are viable options.  

Hypothesis  

An increase in the independent variables, frequency of food establishment inspection and/or change in food law will cause a change in the dependent variable demonstrating a change in foodborne illness rates and risk factor assignment. The null hypothesis (H0) is, “An increase in frequency of inspection and/or a change in food law will not change food establishment risk factor assignment or demonstrate a change in foodborne illness rates”.  

Data and Method  

Data for facility inspections in Atlanta, GA (Fulton County, most of Atlanta), Boston, and San Francisco are public record and available for analysis upon request or through public portals. The different cities’ data is downloaded as csv files and pivot tables are created to create tables, graphs, and analyze information in excel. Risk factors are coded using Boston’s item numbering system to standardize observations in Atlanta and San Francisco for a comparison between levels all things being equal. Risk levels are also tabulated as assigned per state law for comparison.   

Coding provides a means of comparison between different food codes; violation observations are assigned different item numbers in different systems of food law. Subsequently true differences from state assigned risk levels and a standardized risk level can be identified. The violation items are ranked according to risk level and measured annually in each metro subject area per year.  

Data from the CDC on foodborne illnesses and state epidemiology in the sample states will be cross referenced. Comparing the frequency of inspection and changes in food law identify if either variable separately or combined demonstrates a reduction of foodborne illness and change in risk factors that has been identified by FDA as having a causal relationship to foodborne illness.   

Analyzing the Data 

The inspection frequency for each metro area which is naturally modified by staffing levels in inspection programs will be one variable. To control for the differences in training, experience, rules applied, and local policy and practice the same jurisdictions are used over a period of three years or longer the data collected is measured and analyzed. A correlation coefficient, regression analysis test, test of average mean, in addition to other tests are used to examine the relationship between the dependent and independent variables. 

Analysis & Subject City Summary

The three cities in this study Atlanta, Boston, and San Francisco represent three different geographical areas of the United States. Atlanta is in the southeastern part of the county, Boston the northeastern part of the county, and San Francisco the southwest seacoast. Along with geographic differences, the cities have political boundary division differences with both Atlanta and San Francisco being part of the county system of government and Boston part of a commonwealth system. 

. . . 

Analysis and Findings 

Question 1. Is there a correlation between frequency of inspection and food born illness?  

The Correlation Coefficient test provides statistical analysis correlation between variables. The closer the number is to one the stronger the correlation. At -0.794414077 the negative correlation between frequency of inspection and Illness per capita is very high. This would indicate that as the frequency of inspection drops the incidence of foodborne illness increases, and as the frequency of inspection rises the foodborne illness rates decrease.  

Question 2. Is there a correlation in changes of risk factors as laws change?  

The answer to question two is yes, there is a correlation in change of risk factors as laws change. The difference in all risk categories per law in the subject cities is demonstrated by the coded and assigned values by law as shown in table 15. The graph shows the dramatic differences based upon assigned law and coded law; Atlanta and San Francisco’s risk factors levels were coded to compare with Boston’s assigned risk factor levels as the control. Each had different food laws in place and assigned different risk values to their risk levels per violation item. A few easily identifiable examples of the differences are visualized in San Francisco’s use of three different risk levels for rodent and pest observations while Boston and Atlanta use one. Also, Atlanta assigns wiping cloth violations a moderate level assignment while San Francisco and Boston assign it a low-risk level value. San Francisco food law does not place an emphasis on managerial control to the extent that Boston does, the San Francisco Food Code was not as stringent on that item. These violation items show in different positions, representing the different emphasis assigned law placed the items at in the subject states.   

Question 3. Does a change in food code correlate to risk factor changes/ foodborne illness changes independently or in conjunction with frequency of inspection?  

The answer to this question is yes. The difference of means test was conducted for Atlanta, and San Francisco’s coded risk levels and the assigned risk level by state food law. The Difference in mean in Atlanta and San Francisco shows a significant difference in high-risk factors based upon assignment by a different version of food law (Boston, MA risk level assignment based upon Boston’s version of the FDA Model Food Code). This would indicate that law does impact the difference in risk factors all things being equal.  

. . . The difference between coded and assigned risk levels is significantly different in Atlanta and San Francisco, with Boston as the control. San Francisco’s difference was equally as significant with an increase in 2016 from 304 to 972 high-risk factors, in 2017 a rise from 1490 to 4017, even with a less dramatic increase in 2018 from 1349 to 1593, it was still significant. All categories of risk shifted as when coded by the difference in law.  

The difference in assignment of risk values is indicative of a correlation in change of risk factors as laws change; the difference noted in the mean number of coded risk items to assigned in Atlanta . . . demonstrates how significant the change of risk factors by law can be.  

Furthermore, Boston has the highest mean frequency of inspection and the lowest mean Illness (per capita), next Atlanta, then San Francisco; Boston has the highest mean violations and lowest mean Foodborne Illness rates (per capita), next Fulton, then San Francisco.

For question three, using the correlation testing function in Excel with the mean high-risk data and frequency of inspection collected from the subject cities databases. . . . (There is) a high negative correlation between frequency of inspection and Illness per Capita; as the frequency of inspection rises the rate of illness decreases and as the rate of inspection decreases the rate of illness increases. 

 While High Risk Factors show a strong negative correlation to foodborne illness per capita it shows a strong positive correlation to frequency of inspection. This would suggest that the more inspection the more likelihood of capturing high-risk violations for corrective action with high-risk factors acting as a preventative mechanism toward preventing foodborne illness. . . . The relationship between high-risk factors responsible for foodborne illness, complaints, and frequency of inspection; the tables demonstrate how the preventative mechanism of reporting of risk factors for correction impacts foodborne illness when an increase or decrease in the reporting is observed that hinders or assists the function of the preventative mechanism of risk factor reporting. There is a strong negative correlation between frequency of inspection and foodborne illness; as frequency of inspection goes down foodborne illness increases. The data indicates that high-risk factors independently and in conjunction with frequency of inspection factor into foodborne illness rates.  

Null Hypothesis 

The answers to questions 1 – 3 were all yes so, we can reject the null hypothesis (H0), “An increase in frequency of inspection and/or a change in food law will not change food establishment risk factor assignment or demonstrate a change in foodborne illness rates”. 

Summation 

The analysis demonstrates that frequency of inspection has a high negative correlation relationship with foodborne illness as frequency of inspection increases or decreases; foodborne illness will travel in the opposite direction. Every year that the frequency of inspection rose in the subject cities the per capita foodborne illness rate decreased. In the years where frequency of inspection was stagnant the foodborne illness rates were relatively unchanged in the subject cities; this is reflected in the correlation coefficient test. Frequency of Inspection and High-Risk factors have a high positive correlation relationship, the more frequent the inspections, the higher the incidence of high-risk factors was noted. Risk factors are used to reduce foodborne illness, they are a preventative control. By correcting these critical items an establishment can theoretically prevent foodborne illness.  

High-risk factors had a high negative correlation with foodborne illness in the years that foodborne illness decreased demonstrating it functioned as the preventative control it is meant to be. Risk factors were coded by assigned values by state law and under a common numbering system. The design was to see if food law changed the assignment of the risk factors. The coded (control) law and assigned law risk factors did demonstrate a significant difference of means in each year of the study establishing that food law does influence risk factor assignment. 

Recommendations for Future Study  

One of the leading drivers to the success of this study was the ability to access research material through databases. The retail food system would benefit from a study on a viable national electronic inspection platform and information database system, accessible across all states by multiple agencies in all retail food program nationally. The sharing of information in real time is key to identifying factors that can mitigate risks of foodborne illness events, not only at the local level but nationally.  

It is through data sharing that we can create a dynamic food safety system that can impact food borne illness, necessary policy change, and make the most of scares resources in the public health sector. Good policy is always data driven.

A recommendation for future study would be examining different models for Retail Food Programs and State Food Protection Programs and their interactions to determine the most effective and efficient model that could be implemented across the states, territories, and districts.

To correct for differences in food law, one possibility may be a stand-alone federal Act or amendment to the Food Drug & Cosmetic Act to include Retail Food. In the subject cities there were different model versions in the different states. With the FDA Model Retail Food Code changing every four years with amendments every two years it can be burdensome for states to constantly have to go through the legislative process to change versions of the Food Code. This is subject to state legislative processes that may not be bypassed. It can take several years to update versions and is a costly and time-consuming process for departments that are already facing challenges from scarce resources. Several Senators including Senator Durbin have proposed a single food agency over decades to correct for redundancies, deficiencies, and create a uniform food code; the Retail Food program could be a part of that in the future.

A key issue brought up in the GAO MWD-76-42 report in 1975 was the lack of support from the federal to the state level to the local level for retail food programs; this problem has not been addressed to date rendering the same ineffective retail sanitation as found in 1975. It is time to provide data to create solutions to integrate federal, state, and local retail programs and determine the necessary funding required to present to Congress as outlined in the 1975 report. 

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Michael Eckhardt, Senior Vice President, Chief Legal and Risk Officer, and Secretary, Wawa Inc.;  Randy Huffman, Ph.D, Chief Food Safety and Sustainability Officer, Maple Leaf Foods; and David McDonald, President and Chief Operating Officer, OSI Group will join Lone Jespersen, Ph.D., Principal, Cultivate SA, who will lead this important conversation. To access the full education program, visit www.foodsafetysummit.com. 

“Managing risk is such an important topic for food safety professionals at all levels of business, and we look forward to Lone Jespersen leading this conversation with these three dynamic panelists who are committed to balancing risk and safety,” said Gillian Kelleher, CEO of Kelleher Consultants LLC and Chair of the Summit Educational Advisory Board (EAB). “We are confident that attendees to the Food Safety Summit will gain practical perspectives they can share with their senior leaders at organizations of all sizes.” 

“The keynote session will focus on a conversation with forward-thinking executives on the topic of balancing risks for the safety of consumers, team members, and the environment. Participants will hear how successful food companies manage risks that sometimes compete for investments and leadership attention,” explained Lone Jespersen, PhD, Principal at Cultivate SA and member of the Food Safety Summit EAB. “Learning how to partner with colleagues from human safety and sustainability is a must for a company to improve food safety performance and mature a company’s food safety culture. The executives will also share specific challenges and wins from their respective organizations, along with the cultural solutions that help them successfully manage risk.”

The panel will include:

Michael Eckhardt, Senior Vice President, Chief Legal and Risk Officer, and Secretary for Wawa Inc. Michael has responsibility for the Company’s Internal Audit, Enterprise Risk Management, Legal, Loss Prevention, Quality Assurance, Risk Management and Safety teams. Michael joined Wawa in 2005 and became General Counsel in 2011. He previously held the position of Associate General Counsel at Wawa Inc. 

Randy Huffman, PhD, Chief Food Safety and Sustainability Officer at Maple Leaf Foods. His role encompasses leadership of Food Safety and Quality, Occupational Health, Safety and Security, Environmental Sustainability, and Animal Care. Randy leads a team that has developed and is executing world-class strategies to deliver on Maple Leaf Foods’ commitments to produce safe, great-tasting food produced in a safe work environment and to become the most sustainable protein company on earth. 

David G. McDonald, President and Chief Operating Officer, of OSI Group.David joined OSI Group, a multinational food processing company with nearly 60 facilities in 17 countries, in 1987. Over the years, after serving in a number of capacities, he became President and Chief Operating Officer. He serves on the Board of Managers for OSI Group and many of its companies. In addition, David was formerly the Chairman of the American Meat Institute and the first Chairman of the North American Meat Institute. 

“I look forward to having this important conversation with Michael, Randy, and David and to share with the attendees of the Food Safety Summit how all food safety professionals can work with their senior management teams on balancing risk for consumers, employees, and the environment,” added Jespersen.

Attendees will have access to three days of education sessions including an opening workshop on Got Root Cause? featuring a panel of leaders from FDA, Cargill, Dole Food Company, USDA, Yum Brands, and J&J Snack Foods, who will review how getting to the root cause is a cost-effective approach to management/operations in any organization. In addition, the 11^th annual Town Hall: A Conversation with Top Regulators and Advisors will be held on May 11, with insights from FDA, CDC, USDA, and AFDO. 

The Summit’s closing session on Thursday afternoon will focus on Legal Insights to Sharpen Your Food Safety Focus—and Stay Out of the Courtroom. The panel discussion will feature prominent attorneys who work on behalf of consumers and industry — with all advocating on the side of food safety. These internationally recognized expert lawyers will discuss the common gaps or weaknesses they see in company operations, culture, and regulatory adherence that lead to adverse events, such as foodborne illness outbreaks and recalls. 

For access to the full program and for attendee registration, visit https://www.food-safety.com/food-safety-summit. For information on sponsorship or exhibiting opportunities, contact Kim Hansen at [email protected] or Adam Haas at [email protected]. For updates on the 2023 event, visit www.foodsafetysummit.com or follow the event on Twitter, LinkedIn, and Facebook. 

The Food Safety Summit is owned and produced by Food Safety Magazine (www.food-safety.com) and BNP Media (www.bnpmedia.com), one of the country’s leading business-to-business media companies serving industry professionals across 60+ industries through magazines, custom media, e-newsletters, webinars, events, and market research.

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Editor’s note: This is the March 28 written statement of Frank Yiannas, M.P.H.Prior FDA Deputy Commissioner, Food Policy & Response (Nov 2018 – Feb 2023) for the Subcommitte On Health Care And Financial Services U.S. House Of Representatives FDA Oversight Part I: The Infant Formula Shortage March 28, 2023

Introduction 

Chair McClain, Ranking Member Porter, and members of the Subcommittee, thank you for inviting me here today to testify before you and, more importantly, for your interest in better understanding what happened, so we can prevent an infant formula crisis of this nature from ever happening again. 

Our bosses, the American people, and especially the most vulnerable of consumers – infants – deserve that from us, so I thank you for scheduling and conducting this hearing. 

Background 

In late February of 2022, already amid unprecedented supply chain challenges brought upon by the pandemic, our nation’s parents and caregivers learned of a very large recall affecting trusted household brands of powdered infant formula (PIF) products, such as Similac, Alimentum, and EleCare manufactured in a facility located in Sturgis, Michigan. The company that produced these products, Abbott Nutrition (AN), voluntarily recalled these products after learning of multiple cases of infant illnesses caused by a rare and often fatal microorganism, called Cronobacrer sakazakii, which is often associated with PIF. Several confirmed cases of ill infants indicated that all had consumed PIF produced in AN’s Sturgis facility. The illnesses, along with conditions detected at that facility during a FDA inspection, such as insanitary conditions, an environment contaminated with multiple strains of Cronobacter sakazakii, and critical equipment in disrepair, led AN to execute a voluntary recall on February 17, 2022. All in all, there were four infant illnesses of Cronobacter sakazakki linked this incident and, tragically, 2 of them resulted in death. 

My Reason for Being Here Today 

It has been over a year since this incident began. There has already been a Congressional oversight hearing held by a House Subcommittee on Oversight and Investigations in May of 2022. The FDA issued its own version of what transpired in a report in September of 2022 titled, FDA Evaluation of Infant Formula Response. And there has been extensive media coverage of the incident. 

Yet, despite these actions, a clear and transparent understanding of what took place and the contributing factors that allowed it to occur – have remained elusive. It is most critical that we learn from this experience and take collective action as a nation to prevent something like this from ever happening again. 

Consumers deserve better. And there is more that the industry and regulators can and MUST do. 

Therefore, I come to you today without regard to partisan politics, but as a professional who has dedicated my life’s work to protecting consumers, both in the public and private sectors. The organism that caused these tragic illnesses, Cronobacter, does not recognize political parties, so as we search for solutions, neither should we. 

I also come before you today with a balcony level view of what happened. While being made aware of the incident much too late, on February 10, 2022, a complete 4 months since the first of a series of illnesses and a whistle blower report were received by the agency, once I became aware, me and my team jumped into action and began coordinating daily meetings with executives of the various, decentralized offices and centers at the FDA involved with this issue. I also led the FDA’s Incident Management Group (IMG) for the infant formula response, subsequent to the recall taking place. 

What Follows 

For the remainder of this testimony, my intent is to lay out the critical elements or factors that allowed this crisis to occur. My intent is to do that in a fact-finding – rather than a fault-finding – manner. And I hope to place a heavy emphasis in my testimony on the root cause and contributing factors that allowed it to happen, in hopes that it will allow us to focus on preventative solutions. 

Why? Because, a year later, it is my view that the state of the infant formula industry today is not much different than it was then. The public health surveillance system for this pathogen remains insufficient, the necessary safeguards have not been advanced or strengthened at an adequate pace to prevent a re-occurrence or future illnesses, and the infant formula supply chain continues to lack resiliency. In other words, the nation remains one outbreak, tornado, flood, or cyber-attack away from finding itself in a similar place to that of February 17, 2022. 

That place is a repeat scenario where parents hear of infants becoming severely ill due to Cronobacter sakazakii, finding shelves at their local grocery store empty for their desired infant formula products, and having to worry about the safety of what they are feeding their infants. 

Below, I would like to spend the next few minutes walking you through my recollection of events, which I hope will paint a picture of why I am focused on these key areas. 

Inadequate Public Health Surveillance for Illnesses caused by Cronobacter sakazakii 

In 2011, Congress passed the Food Safety Modernization Act, known as FSMA. Their mandate to the industry and FDA then is still true today. It’s not enough to respond to illnesses, outbreaks, or recalls of food after they happen. We must do more to prevent them from happening in the first place. 

Much of what we know about foodborne illnesses, their frequency, severity, the foods that serve as primary vehicles for transmission, as well as common routes of contamination, is a result of progress made possible by foodborne disease surveillance efforts. Foundational to improvements to the food safety system is a modern foodborne disease surveillance program. As stated by Dr Scharff and Dr Hedberg in the book Food Safety Economics, published by Springer Scientific, “a foodborne illness surveillance system is designed to collect, analyze, and disseminate information about foodborne illnesses. Consequently, they help solve critical information problems faced by consumers, firms, and government agencies. By providing better information to the market, these surveillance systems create incentives (accountability) that leads to safer foods and better consumer awareness.” 

In this instance, the foodborne disease surveillance system for Cronobacter sakazakii failed us and it MUST be improved. 

Unlike other foodborne illnesses, Cronobacter sakazakii infections are NOT a nationally notifiable condition and is not reportable in most states. According to the Centers for Disease Control and Prevention (CDC), Minnesota and Michigan are the only states that require reporting and the CDC reports that they typically receive reports of only 2 to 4 Cronobacter infections in infants per year. That means that there are likely cases of severe infant illnesses and deaths, although presumably rare, occurring in the United States due to Cronobacter and that those cases remain anonymous, unreported, and invisible to most of the nation. 

A study by the CDC in 2014, published in the Journal of Emerging Infectious Diseases, titled Incidence of Cronobacter spp. Infections, United States, 2003–2009, estimated that the incidence of Cronobacter sakazakii among infants (zero to one year of age) was 0.49 per 100,000 population. 

As illustration, for the incidence of another pathogen that is of low frequency but high severity, Listeria monocytogenes, the CDC estimates that there are 0.31 laboratory-diagnosed, domestically acquired infections per 100,000 population. This incidence rate is lower than that of Cronobacter among infants, the most vulnerable of consumers, yet Listeria is a reportable disease, but Cronobacter is not. It is only through reporting, and utilization of tools such as whole genome sequencing (WGS) of the isolates of Listeria monocytogenes detected that we have advanced what we know about Listeriosis. Because of that, today, we now know that many of the cases of Listeriosis that were once assumed to be isolated or sporadic, are not isolated at all. Increasingly, these cases are linked to a common food vehicle, allowing implicated foods to be taken off the market quicker, preventing additional illnesses, and outbreaks from getting larger. This, in turn, is enhancing our ability to create strategies to strengthen future prevention. 

Lastly, in regard to making Cronobacter sakazakii a nationally notifiable condition, you have probably heard that this is not something the CDC, nor FDA can do on their own. There is a process through a body called the Council of State and Territorial Epidemiologists (CSTE) that meets annually to deliberate and vote on position statements and changes to national policy on notifiable conditions. This is a complicated process that is hard to explain to concerned parents, consumer groups, or public health advocates that wanted a change in notification policy to happen immediately after this issue was recognized. The CSTE is scheduled to meet in June of this year and I’m grateful that the FDA has been working to get this issue on the agenda. We MUST change this and make Cronobacter a nationally notifiable condition just like Salmonella, E. coli O157, and Listeria. 

Early Signal Detection and the Need for Rapid Response 

As previously reported, the FDA began receiving a series of reports or complaints of infants who had been confirmed to have been infected with Cronobacter sakazakii, all who had also consumed infant formula products produced from a single manufacturing plant located in Sturgis, Michigan. 

In addition, on October 26, 2022, the agency received a Whistle Blower complaint, submitted to various FDA personnel through various means (hard copies via Fed X, as well as electronic copies submitted via email). 

In summary: 

• The first report of an infant ill with C. sakazakii (which resulted in death) was reported to the FDA on Sept 20, 2021
• On October 26, the Agency received a Whistle Blower complaint alleging egregious conditions and practices at the Sturgis facility.
• The second report of an infant ill with C. sakazakii was reported to FDA on Dec 1, 2022
• The third report of an infant ill with C. sakazakii was reported to FDA on January 11,
  2022, and
  
• The fourth report of an infant ill with C. sakazakii (which resulted in death) was reported to the FDA on Feb 18, 2022.
  It should be noted that while the FDA conducted an inspection of AN’s facility located in Sturgis on September 20, with the inspection lasting until September 24 of 2021, the inspectors on site were unaware of the complaint the agency had received of an infant illness due to Cronobacter on the same date, September 20, the day the inspection began. It would have been useful for investigators to have had that information on hand, as it could have potentially resulted in a different or more in-depth path of investigation.
  While FDA did conduct notifications to the company of the illness reports as they came in and did slowly take steps to follow-up on the Whistle Blower complaint, it wasn’t until January 31, 2022 (four months later) that the FDA began an official inspection of the AN’s Sturgis facility and it wasn’t until February 10, 2022 that I personally became aware of the series complaints, the whistle blower report, and the findings from FDA’s January inspection that resulted in multiple environmental swabs being found positive for Cronobacter sakazakii in the facility.
  Some have questioned if quicker action by the agency on some of the earlier signals could have avoided or lessened the magnitude of the crisis. While there is disagreement within FDA on this point, I believe most professionals experienced in crisis management would say the answer is yes. The literature is full of examples of organizations that either failed to piece together early signals or failed to heed early warnings that eventually allowed a crisis to grow worse, 

rather than being contained. I believe that the literature of the future will also conclude that this incident is a sad example of how FDA’s siloed organizational structure and culture impeded rapid critical problem identification, communication, and response. 

Taking Whistleblower Complaints Seriously 

In the Congressional hearing last spring, there was a lot of discussion about the whistleblower letters addressed to Drs. Woodcock, Mayne, and McMeekin being lost in the various FDA mailrooms for months. But what also concerns me greatly is the fact that the 30-plus page complaint was also sent by email to staff in the Office of Regulatory Affairs and CFSAN, but the concerns were not handled with the appropriate sense of urgency. Given the concerns expressed and the vulnerability of infants, this should have been elevated to leadership immediately. As Deputy Commissioner for Food Policy and Response, I was not sent the October 26, 2022 whistle blower complaint, and I did not get an opportunity to see the complaint until I was made aware of the incident in February 2022. 

I would argue that FDA’s structure and culture exacerbated these delays. With siloed groups in the FDA’s decentralized Foods Program, it is impossible for leaders, even leaders like me that had titles that might indicate otherwise, to have clear line of sight on what was happening or to set processes in place to help catch these critical public health concerns. The current structure results in regular communication breakdowns, and results in the potential for food safety concerns to fall through the cracks altogether. 

Eventually, the informant was interviewed by FDA personnel on December 22, approximately 2 months after the letter was received. While the concern over why it took so long to interview the informant is valid, as well as who were the individuals that received the letters, there is one significant conclusion that was not mentioned in the timeline and that did not come up during the initial hearing last spring. Upon completion of the interview with the confidential informant along with their lawyer present, the FDA investigators concluded that the complaint was “too vague” and did not warrant follow-up. Having read the letter myself and the very specific allegations of falsification of records, attempting to deceive federal relators, and more, it’s hard for me to agree with outcome of the investigators’ determination and, this too, could have played a role in delaying a greater sense of urgency by agency personnel aware at the time of the matter. 

Again, FDA’s future structure needs to be one in which the leader of the Foods Program can have clear line-of-sight on issues such as these and to take steps to ensure that the culture at FDA is one in which investigators recognize the need to take rapid action to follow-up on allegations like these. To accomplish this, FDA will need to empower a food safety leader with accountability for not just the Foods Center, but also the field inspectional resources in the Office of Regulatory Affairs. 

The Weight of the Evidence Against Abbott 

The inspection of the Abbott Sturgis facility initiated in January 2022 resulted in a number of findings that led to great concern for me and my colleagues and resulted in the large recall. 

Abbott Nutrition and some others have suggested that their products were not the source of illnesses, because the genetic strains of Cronobacter sakazakii were never found in product, nor in the Sturgis facility. This information is misleading. 

Thus, I would like to present a series of facts, regarding the weight-of-the-evidence of the problem at Sturgis that I was considering as we made the decision to request action by Abbott. 

1. Increased Reports of Cronobacter infections over a Short Period Time – the FDA received 4 reports of confirmed C. sakazakii infections in infants over a short period of time, which is unusual, given that it is NOT a reportable illness in most of the U.S. Again, the CDC reports they have historically received 2 to 4 cases reported per year. 

2. Traceback – all 4 infants that were infected had ingested PIF products manufactured at a single location (AN’s Sturgis facility), which is significant. While AN certainly had a large market share, it was only one of 21 formula plants servicing the US market at that time. 

3. Microbiology – FDA investigators readily found multiple environmental samples positive for C. sakazakii in the Sturgis plant in just a two-day period. 

4. Genetic Diversity – five (5) different strains of C. sakazakii were detected using WGS of isolates in found the environment at the Sturgis facility, indicating contamination with multiple strains could occur. 

5. Lack of Environmental Control – FDA’s subject matter experts, well versed in infant formula production, described environmental conditions at the Sturgis facility as “out-of-control” and a potential source of recontamination. 

6. Old Spray Dryer with Large Cracks – FDA investigators observed two sprayer dryers, one purchased in the 1960s, with large, unrepaired cracks, potentially serving as harborage points and sources of recontamination. This same scenario has been documented in the literature to have caused a PIF outbreak. 

7. Known Product Contamination – FDA investigators learned that AN previously destroyed 2 batches of PIF contaminated with Cronobacter produced at Sturgis, even though it is well documented in the literature that low levels of sporadic contamination is unlikely to be detected by PIF sampling plans. Therefore, it is more likely than not that other batches of PIF produced in this plant were likely to have been contaminated with a variety C. sakazakii strains, which evaded end-product testing, and were released into commerce. 

8. Lax Standards – events were recorded such as 

• contract workers moving from the roof to a production line in dirty boots, highlighting yet further avenues of potential contamination in the plant. 
• numerous water events were documented including water leaks, moisture, and condensation in dry powdered infant formula production areas. 
• spray dryer inspections in August 2021 showed six instances of cracks and pits in the main chamber recorded for spray dryer #3 and six instances of cracks, pits, and damage in dryer #4 

9. PIF as a Vehicle of C. sakazakii – contamination of PIF with C. sakazakii is well documented and has been the cause of small outbreaks and sporadic infections, sometimes with serious sequelae or death. 

10. Low Significance of Lack of WGS Match – because C. sakazakii infections are not reportable in most states, it makes it more difficult to identify & link infections that may appear as sporadic in nature (i.e. Listeria). In this incident, four C. sakazakii infections were passively reported to FDA. Isolates were available for only two infants for WGS characterization. Having only two of four clinical cases characterized by WGS, and a scarce library of previous sequences, made it more difficult to compare limited infant infections with the multitude of strains (5) recovered from the firm, as well as previous documented human cases. 

Based on the points summarized above, Abbott’s Sturgis facility lacked adequate controls to prevent the contamination of powdered infant formula with C. sakazakii. There is also evidence that sporadic contamination of finished product actually did occur, and it is likely that other lots of PIF produced in this plant were contaminated with multiple C. sakazakii strains over time, which evaded end-product testing, were released into commerce, and consumed by infants. 

Lastly, and in summary, the factors presented above supported a conclusion that PIF made at Abbott’s Sturgis plant was produced under insanitary conditions and a likely source of ongoing, sporadic contamination of PIF with multiple strains C. sakazakii over time, notwithstanding a lack of a match by WGS between the plant’s environment and/or finished product and two clinical isolates. 

Need for Strengthening Preventive Controls within the Infant Formula Industry (Modern Facilities, Sanitary Design, Environment Monitoring, & Enhanced Verification) 

A key lesson learned for me is that we need to update infant formula policies to strengthen prevention. While the conditions at the Sturgis plant were egregious, the Sturgis plant is not the only plant that has experienced problems with Cronobacter. As you may have seen in the news, there have been multiple recalls recently associated with the potential for Cronobacter at other facilities. We need to incorporate the lessons learned from recent events and update FDA’s infant formula rule. One key example is our current testing regulations. Using the current testing requirements, the chances of detecting Cronobacter are much smaller than they should be. 

These standards need to be updated so that firms have a greater chance of detecting contamination events. 

We also need to work more with industry to ensure production facilities are state of the art. In 2023, we should no longer be producing food for infants using equipment that is showing its age and increasing the risk of potential problems. Some of the equipment still being used in some of the biggest production facilities today was installed before I was born. Back then, we knew far less than we do now. 

Fulfilling Our Public Health Mission – Protecting Infants 

From the time I first learned of the incident, on February 10, 2022 to the time it took Abbott Nutrition to conduct a voluntary recall to protect infants, it was 7 days. Seven days contrasted to the 4 months of time in which the series of events unfolded. 

Beginning on February 11, 2022, as Deputy Commissioner of the Office for Food Policy and Response, I begin a series of daily meetings, sometimes more than once a day, with all Food Program principles and offices to include ORA, CFSAN, Legal, and Media Relations to coordinate activities and to work as one FDA Foods Program Team. 

I wish that the communications silos had not existed and that I would have been notified earlier, so I could have initiated these steps sooner. I also believe that had we been able to initiate these steps and act sooner, the recall may have been smaller in size. 

Addressing the Impact of the Recall 

My Office initiated a prompt and escalated level of communication that informed major parts of the United States Government (USG) including the USDA and White House, of the evolving incident and its likely effect on infant formula supply availability. 

The series of actions taken at all levels of the USG were well summarized in the hearing testimony provided in May of 2022 and, in my view, those collective actions were quite heroic. Below is a recap of select and notable actions. 

o Asking retailers to quickly place limits on the number of units that could be purchased.

o Meeting regularly with major infant formula manufacturers to better understand and maximize their capacity to increase production of various types of infant formulas and essential medical foods.
o The prompt acquisition of needed data and monitoring the status of the infant formula supply by using the Agency’s 21 Forward food supply chain continuity system, combined with external data.
o Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.
o Implementing a new process to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. These flexibilities allowed for a small volume of infant formula to augment existing and newly produced supplies. 

o The Administration invoking the Defense Production Act, directing firms to prioritize and allocate the production of key infant formula inputs to help increase production and speed up supply chains. 

o Launching Operation Fly Formula and coordinating with the Department of Health and Human Services and U.S. Department of Agriculture (USDA) to leverage Department of Defense contracts with commercial air cargo lines to pick up overseas infant formula that met U.S. health and safety standards, so it could get to store shelves faster. 

o USDA offering state health commissioners flexibilities through WIC to determine products that may be substituted for recalled products, allowing families to purchase different container sizes and physical forms, and allowing purchase of noncontract brands, and waiving retailer minimum stocking requirements to allow formula to transfer to where it was most needed. 

o Congress passing the Access to Baby Formula Act of 2022 to expand access to baby formulas for certain American families during the supply chain disruption. 

The Recall’s Effect on the Infant Formula Shortage and Additional Factors that Could Have Minimized Disruptions 
Clearly, the overarching measure that could have prevented this crisis from happening in the first place was Abbott Nutrition’s operating conditions, procedures, standard of care, and commitment to maintaining a strong food safety culture. Simply put, what was found at Abbott’s Sturgis facility was unacceptable and Abbott Nutrition bears the primary responsibility for this crisis. 

Also, as previously mentioned, earlier detection of signals by Abbott, public health officials, and/or regulators could have allowed this incident to unfold in a less catastrophic manner. 

However, after the series of events were allowed to escalate and build upon each other, by the time February of 2022 came along, containment of this incident became much harder. 

There were longstanding gaps in Federal action on supply chain monitoring and resiliency actions that both helped to create a situation in which a single plant going offline could have such a tremendous impact. It also made it hard to have the intelligence needed at our fingertips to inform decision-making. 

Even before the recall on Feb 17, 2022, the United States was already facing infant formula supply chain stress. Thus, as evidence of this cascading situation unfolded, the FDA knew that it had to act to protect infants, but that with an impending large recall of infant formula by a major market player, it also had to do everything it could, along with other USG partners, to minimize disruptions and potential shortages. 

Per FDA’s own Regulatory Procedures Manual, in Chapter 7 titled Recall Procedures, it states that “ORA and the Center (in this case, CFSAN) will also determine whether the recall could cause a shortage of regulated products.” However, the FDA’s Food Program was ill equipped to do a proper analysis of the effects of the recall on supply availability, as the team at CFSAN responsible for infant formula products lacked the type of quantitative infant formula supply chain insights, data and analytical capabilities to conduct a more thorough analysis of the potential impact, simulate scenario planning, nor an ability to quickly determine what measures could be taken to accelerate a recovery. 

21 Forward – a Food Supply Chain Data Analytical Platform 
Prior to 2020, the Foods Program had no data system in place to monitor key food supply chains. During the COVID-19 crisis, many in federal service, including myself, felt it was our duty to do all that we could to gain better, data driven insights into the structure, function, and resilience of food supply chains, so that we could continue to meet the needs of the American people. Food and agriculture was one of those critical infrastructures that had to stay in operation to serve the public, and those of us working on this recognized that food security (ensuring people have access to food) was a matter of national security. Thus, we quickly realized that to protect and harden FDA-regulated food assets against the risk of SARS-Cov-2 transmission among food workers, we would need better data, insights, and additional data sets. And, thus, the idea of 21 Forward was born. 

In record time and on a shoestring budget, my team, in partnership with other offices and an outside vendor, built the 21 Forward System, a first of its kind food supply chain data analytical platform that could be used to increase resiliency of the high priority food supply chains against COVID-19 related disruptions. It was achieved by transposing several ideas, leveraging disparate, but relevant data sets, and combing them with different computational capabilities. The system was used to strengthen FDA-regulated food assets from COVID-19 disruptions, including infant formula plants. As the infant formula crisis unfolded, we built on this system and turned it into the data platform for the entire USG response. 

What the cross-governmental team did to build this platform was amazing and is a shining example of the dedication of public servants who worked around the clock to make this happen. But really, we shouldn’t have been building this on the fly – it should have been in place years ago. 

FDA had not made these investments because historically, the Agency’s food mission has centered around food safety and nutrition. Even as COVID created the biggest challenge to the food system in a hundred years, there was internal debate at the agency on whether there was really a role for the FDA in monitoring food supply chains. 

Requests for funding to further develop the 21 Forward system were met with resistance by the previous Acting Commissioner and Director for the Center for Food Safety and Applied Nutrition. In fact, one very specific request in advance of the infant formula crisis was declined by Agency leadership, despite Congress giving the agency unprecedented levels of money in the way of a COVID supplement funding to develop such capabilities. In hindsight, this was a big miss that would have enabled the Agency to respond to the infant formula crisis in a quicker, more thorough, and data-driven manner. 

It was particularly frustrating to me and my staff that our early work on 21 Forward more than a year before the Abbott recall had highlighted for us the concentration of infant formula manufacturing, and we wanted to build out the monitoring tools to get a better handle on critical supply chains like these. In interagency discussions, we were raising infant formula as a good case study to advance supply chain actions – we had the right initial insights, and we were trying to make the case for resources – the emergency just came before the USG was ready. 

Having lived this experience, I am grateful that Congress has directed the Center for Food safety and Nutrition to establish an Office of Critical Foods and the necessary capabilities to monitor these critical foods for potential disruption. I urge you to ensure that this office builds the appropriate monitoring tools and I urge you to continue to clarify expectations for the roles this new office and other parts of the Federal Government as they pertain to supply chain monitoring and mitigation actions. 

A Fragile and Inelastic Infant Formula Supply Chain 
Lastly, one should wonder, how does the shutdown of 1 of 21 infant formula plants serving the U.S. market cause such a shortage and disruption. And what were the factors that led to the creation of such an inelastic and fragile infant formula supply chain system. 

The reality is that the FDA has had minimal authorities and levers to affect the system, other than the safety and nutrition standards they create and their ability to approve new markets submissions in a quick manner. However, like most supply chains, financial implications, incentives, and disincentives play a huge role in ultimately influencing how supply chains evolve. Thus, I am grateful that Congress, through the Omnibus, has requested that an Infant Formula Supply Chain Resiliency report be completed and submitted to them for review. 

It is critical that Congress look for ways to encourage competition and redundancy of manufacturing in this industry. FDA has a role to play with its infant formula policies, but FDA is not alone. American taxpayers pay for about half of the infant formula sold in the U.S. through the USDA-WIC program. I would argue that the sole-source state WIC contracts helped to create the current concentrated supply chains. But WIC may also provide unique opportunities to address the need for greater competition and redundancy going forward. Congress must stay laser-focused on the resiliency report and create a more holistic approach that will keep us from repeating a scenario in which a single facility is the only manufacturing site for specialty formulas, and there is no back-up production capacity. Congress must insist that critical foods like formula not be one outbreak, tornado, flood, or cyber-attack away from a scenario similar to that of Feb 17, 2022. 

Recommendations 
In closing, I would like to leave this subcommittee with a brief list of select recommendations. 1. It’s time to make Cronobacter sakazakii a nationally notifiable disease.  

2. We should conduct WGS on all isolates of Cronobacter whether they come from clinical, environmental, or food samples and enter those genomic sequences into the National Center for Biotechnology Information (NCBI) database.
   
3. The FDA must enhance its ability to detect signals of potential safety concerns with regulated products and act on them with a greater sense of urgency.
   
4. Congress should address the cultural, siloed, structural, and leadership issues in the FDA Food Program that contributed to a less than desirable response to this incident.
   
5. Demand that the Infant Formula Industry set higher standards of care for themselves that include more modernized productions facilities and equipment, stronger preventative controls, enhanced sanitary design, more aggressive environmental monitoring, and statistically strengthened verification procedures.
   
6. Strengthen regulatory requirements for infant formula manufacturers to include more robust sanitary design, environmental monitoring, a revaluation of sampling plans beyond N=30 for Cronobacter, and mandatory reporting of product positives to the FDA.
   
7. Re-evaluate the thoroughness and frequency of FDA inspections conducted at infant formula manufacturers.
   
8. Re-invent the process used by FDA and health officials to investigate confirmed reports of Cronobacter sakazakii linked to a particular infant formula product. Right now, the process used is unscientifically overweighted on testing a few cans, without knowledge to how closely where those cans were produced in relation to the consumed product and without emphasize on the lack of statistical significance to the test results.
   
9. Dramatically improve consumer and physician education on the appropriate use and handling of PIF in hospitals and homes, as well as recommendations to use alternative sterile, liquid formulations for at-risk and premature infants.
   
10. Support the development of more modern, data-driven Food Supply Chain Analytic Platforms, such as 21 Forward, as a tool to address food supply chain challenges using data-driven insights.
    
11. Complete an in-depth Analysis of the Structure and Resilience of the Infant Formula Supply Chain in the U.S. and implement policies that will promote competition, diversification, resiliency, redundancy, and every day low costs for consumers.
    

Conclusion 
In closing, ensuring the safety and availability of an often sole-source of nutrition, such as infant formula, is a tremendous responsibility for the industry that makes them and for the agencies that regulate them. The infant illness and deaths due to Cronobacter, the Abbott Nutrition recall, and the cascading and devasting effects it had on infant formula availability in our country was a preventable tragedy. It is my hope that we transparently seek the lessons learned and take the necessary actions to prevent such a crisis from ever happening again. Clearly, there is more the industry and regulators can and MUST do. 

I thank this subcommittee and its members for your interest and I look forward to answering any questions you may have. 

Editor’s note: Following is Tuesday’s testimony of Peter Lurie, MD, MPH, President and Executive Director, CSPI, before the U.S. House of Representatives Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services

I want to thank Chairwoman McClain, Ranking Member Porter, and other committee members for inviting me as a witness on behalf of the Center for Science in the Public Interest (CSPI). CSPI is an over 50-year-old advocacy group that acts as a watchdog on food and health issues on behalf of US consumers. We do not accept donations from either government or industry. I am its President and Executive Director and a former Associate Commissioner at the Food and Drug Administration (FDA). While there I worked on drug shortages, with which the powdered infant formula shortage situation shares many similarities.

If we are to apportion blame for the now-resolving powdered infant formula crisis, we should start at the Abbott Nutrition plant in Sturgis, MI that produced the formula associated with an outbreak tied to four hospitalizations, including two deaths. It was there that infant formula contaminated with Cronobacter sakazakii was destroyed years before the outbreak without FDA being notified. 

It was there that, according to a whistleblower, there were lax cleaning practices, falsified records, and relevant information hidden from FDA inspectors.

And it was there that repeated FDA inspections revealed standing water, decaying dryers, failure to follow sanitary practices and, eventually, multiple environmental samples on medium- and high-care areas positive for Cronobacter sakazakii. While many questions remain about the outbreak, including how the Cronobacter may have entered the product (the outbreak strain was not one of those captured among the environmental strains FDA detected), these conditions, the increasing numbers of cases, and the deadly nature of Cronobacter infection left FDA with little choice but to insist that the company recall affected product.

If the U.S. infant formula market had been characterized by vigorous competition, the ensuing recall of Abbott formula would likely not have catapulted the market into a full-blown shortage, with parents having to go from shop to shop in search of dwindling supplies. But, prior to the recall, Abbott was estimated to control about 40% of the U.S. formula market, with about half of that coming from the Sturgis plant. Moreover, just four companies controlled about 90% of the domestic market. This left the U.S. with few alternative suppliers as the recall hit. Market concentration is one of the factors behind the ongoing drug shortage problem as well.
 

These conditions had existed for years, but it took the addition of a pandemic, with its own supply chain problems, Abbott Nutrition’s deficient manufacturing practices, and, later, the war in Ukraine, to produce a full-blown shortage

Much of the FDA response was entirely appropriate and drew from its drug shortage experience. The agency convened an Agency-wide Incident Management Group, sought to identify alternative suppliers that could increase their production, exercised enforcement discretion on a case-by-case basis to allow product to reach the market, facilitated the importation of products from abroad, and used a risk-benefit approach to release the most critical products, such as specialty metabolic and amino acid formulas. Other parts of the government contributed, too, including invoking the Defense Production Act to give formula suppliers priority access to critical ingredients and Operation Fly Formula in which the Department of Defense flew in formula from abroad.

In other respects, FDA’s performance failed to live up to the high standards American consumers expect and deserve from the agency responsible for keeping our food supply safe. A whistleblower report went undelivered to senior agency staff for months and the agency took too long to schedule a repeat inspection of the Sturgis facility, even as Cronobacter sakazakii cases continued to be reported, thus delaying the resultant recall. The agency ordered an internal review of its own response but that report, while offering many strong recommendations, failed to provide a clear account of the events surrounding the recall or the mistakes made by agency officials.

Better prevention and management of future crises requires at least three elements: authority, funding, and an effective organizational structure.

On the first, the Food and Drug Omnibus Reform Act provided FDA with some important additional authorities. It required formula and medical food manufacturers to develop a redundancy risk management plan to identify and evaluate risks to their supply. It mandated the creation of an Office of Critical Foods at FDA, which will manage the regulation of infant formula and medical foods. Perhaps most critically, it required critical food manufacturers to notify FDA of interruptions in manufacturing likely to lead to meaningful disruptions in supply.

To better protect U.S. infants, the agency needs additional authorities. It should have the authority to require manufacturers to notify the agency of positive test results for relevant pathogens and to require more frequent environmental testing in production facilities. FDA should also have the authority to compel manufacturers to submit supply chain data, allowing the agency to analyze and respond to evolving issues. In addition, the Office of Critical Foods should be able to designate additional foods in a public health emergency and require notification of potential shortages related to those foods. Finally, the Council of State and Territorial Epidemiologists and Centers for Disease Control and Prevention should add Cronobacter to its list of nationally notifiable diseases and conditions and more states should join Minnesota and Michigan in including Cronobacter as a reportable disease.

Second, the food program at FDA requires more funding.

Despite efforts by Congressional appropriators to boost funding for FDA’s Center for Food Safety and Applied Nutrition (CFSAN)  and to fully fund the Food Safety Modernization Act, rising costs have left the food program with a number of FTEs similar to what it had in 1978.

Yet, not only has the food industry evolved dramatically since the 1970s, but FDA has been given more and more responsibilities from Congress, including broad new mandates over infant formula, dietary supplements, food labeling, and food safety.

The President’s FY 2024 budget calls for $152 million in necessary new funding for FDA’s foods program, which will allow the agency to hire 195 additional FTEs. This amount will include $64 million for Healthy and Safe Food for All, including support for improved oversight of infant formula, as well as $12 million for Nutrition, a critical funding stream as FDA seeks to establish a Center for Nutrition that will house its Office of Critical Foods.

CSPI believes the number dedicated to nutrition in the Presidents’ budget is in fact too small, and a figure closer to $24 million is needed to adequately fund this important work. Adequately funding the food program is critical to assuring an optimal infant formula supply.

Such funding would support increased review capacity for infant formula premarket notifications, improving surveillance of formula-related adverse events, the development of laboratory methods for Cronobacter sakazakii, and more rapid review of inspection findings.

Finally, Americans deserve a food program that is transparent, effective, and accountable. The formula crisis laid bare the high level of dysfunction, breakdowns in communication and lack of clear lines of authority that characterized the agency’s response.

The reorganization plan announced by FDA Commissioner Robert Califf on January 31, 2023, is an important step on the path towards addressing these issues.  This proposal follows from a report on the human foods program ordered by Dr. Califf and conducted by the Reagan-Udall Foundation. The proposed reorganization captures the spirit of the Reagan-Udall Foundation report, addresses the most critical problems identified, and does so in a manner that minimizes internal disruption:

• It elevates the food program to the Deputy Commissioner level (higher than any other FDA product Center).
• It dissolves a dysfunctional structure whereby three senior officials with authority over the human foods program all reported to the Commissioner and none had clear authority over the program.
• It clarifies the relationship between the human foods program and the Office of Regulatory Affairs, which inspects facilities. FDA has stated that “the Deputy Commissioner would set the priorities for field activities, direct how the resources will be used, what risks will be prioritized, and inspection strategy.”
• It establishes a new Center for Excellence in Nutrition.
• It creates a new Office of Critical Foods.

While additional detail on exactly how these new structures will be operationalized is still necessary, this proposal is a significant step forward, creating a foods program led by a leader who is more empowered and accountable than any food program leader in recent history. The proposal lays a strong foundation for a newly enhanced food program at FDA, one that could ensure a safer and healthier food supply for us all. No mother, no father, should ever again face a desperate, store-by-store search for a product to nourish their infants.

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By Natalie Dyenson and Deb Kane

Simply stated, Root cause analysis (RCA) is a problem-solving method used to identify the underlying cause or causes of a problem or issue, in order to identify appropriate solutions and resolve issues in a permanent manner. Getting to the root cause is a cost-effective approach to management and operations in any organization. Identifying the root cause allows for implementation of effective corrective and preventive actions to avoid reoccurrence of issues and is a crucial step in managing risks.  Preventing reoccurrence typically means you successfully “Got to the Root Cause” of your problem or issue, however despite its importance, many people still view RCA as a complex and confusing process.  In this workshop, we will demystify the process of RCA by breaking it down into simple, easy-to-understand steps.  We will also shed light on Regulatory expectations for the investigative process, due diligence needed for any investigations and provide insights on best practices for successful implementation currently used within the industry.

Whether you are a novice or an expert, we’re asking that you join us on Tuesday May 9, 2023, at the Food Safety Summit, being held at the Donald E. Stephens Convention Center located in Rosemont, IL as we kick off the first workshop “Got Root Cause?” This in-depth standalone session promises to be both educational and interactive, and we’ve organized the following subject matter experts to lead the discussions: Tim Jackson (Sr. Science Advisor, FDA), Tim King (Founder, Quality Matters LLC), Angie Siemens (VP, Food Safety, Quality & Regulatory, Cargill), John N. Butts (Principal, FoodSafetyByDesign, LLC), Natalie Dyenson (VP, Food Safety & Quality, Dole, plc.), and Deb Kane (VP, Food Safety, Quality, EHSS & Regulatory, J&J Snack Foods Corp.).

We will review why it is critical to get to the core root cause of problems utilizing such tools as the “Five Whys” or “fishbone diagrams” and our experts will provide tips on when and how to use such tools.  We will discuss essential information needed to launch an investigation, who to involve in the investigative process, what type of data should be reviewed and how to use existing data collections to cast a wide net to avoid bias as you work to formulate your hypotheses.  You will learn how to organize all inputs and data, and the resultant monitoring activities needed to verify effective corrective and preventive actions.  

The panel session will also include engaging moderators Brendan Niemira (Research Leader, USDA-ARS) and Robert Prevendar (Director of Global Food Safety & QA, Yum! Brands) to guide you through interactive group activities which will provide attendees with the opportunity to practice using the demonstrated tools and apply learnings from the workshop alongside your fellow colleagues during a simulated case study exercise. This sort of iterative learning technique will provide a unique opportunity for a one-of-a-kind hands-on learning experience you won’t want to miss.  

So if you want to network with colleagues in the industry, learn about new tools and techniques or just refresh your root cause analysis skills, this workshop is the place to be!  

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Editor’s note: This was written in response to comments made by FDA Commissioner Dr. Robert Califf in his exclusive interview with Food Safety News Publisher Bill Marler that posted on Feb. 27.

Dear Dr. Califf,

The FDA Foods Program is different. The food system and food safety are complex, but the core of FDA’s food safety role and congressional mandate is straightforward. FDA establishes standards and guidance for industry and engages with industry and regulatory partners in multiple ways to assure compliance with those standards. The Foods Program mission is fundamentally different from Google or a hospital.

As logical as matrix management may sound, it is a prescription for continued failure of the FDA to live up to the vision and mandates of the Food Safety Modernization Act (FSMA). 

As representatives of the food industry and consumers, and state food regulators who have worked directly for many years with all levels of the Foods Program and share an abiding commitment to FDA’s food safety success, we offer the following:

1. Culture Change Requires Central Leadership. FDA’s food safety success depends on headquarters and field inspection, laboratory and import units working seamlessly with a common vision, sense of mission, and priorities.  The change needed will not be achieved solely by defining decision rights in a matrix management system. It’s about culture change, and it’s about leadership that can transform the field units from their entrenched react and enforce culture to one of public health prevention and collaboration to achieve food safety, supported by enforcement when necessary. 

2. Previous Attempts at Matrix Management Have Failed. Beginning with a partially empowered Deputy Commissioner for Foods and Veterinary Medicine from 2010-2018 and Commissioner Hamburg’s Program Alignment, matrix management for FSMA implementation has been tried for over a decade in multiple formulations and has glaringly failed. We see no basis for believing it will succeed now.

3. The Need for a Single Empowered Leader is Well Documented. The failure of matrix management in the Food Program was documented thoroughly by the Reagan-Udall Foundation Independent Expert Panel. On that basis, the panel recommended that all elements of the Food Program be unified under a single leader with full line management authority to lead its essential culture change and program modernization. Thus far, there has been no convincing explanation to rebut this recommendation.

4. Food Safety Requires an Integrated Food Program. For FDA to succeed on food safety, its large frontline workforce needs to think of itself as, and become, an integral part of the Food Program, not remain a separate organization that protects its independence and its outdated culture of insularity and reaction to food safety problems.  

5. Integrating the Field Force Does Not Undermine Efficiencies. Desirable efficiencies in logistical and administrative support to the Food Program’s field activities can be achieved through shared services with medical product programs, rather than holding onto the fragmented ORA Food Program structure that blocks food safety progress.

We urge you to reconsider your plan to rely on a failed matrix management approach to leading and transforming the Foods Program. We recognize that major organizational change often encounters internal questions and resistance. These need to be considered but the stakes are too high to let bureaucratic issues block progress that is so vital to America’s health and to public confidence in FDA’s oversight of food safety.

Food safety success requires and deserves better.

STOP Foodborne Illness
Consumer Reports
Consumer Brands Association
Association of Food and Drug Officials

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Editor’s note: The Consumer Brands Association and Consumer Reports were featured in The Hill Opinion on Feb. 22 for sounding the alarm on FDA’s refusal to appoint a fully empowered deputy commissioner for foods as a necessary step to fix the structural problems that led to the infant formula crisis.

The piece was written by Consumer Brands’ Vice President of Regulatory and Technical Affairs Roberta Wagner and Consumer Reports’ Director of Food Policy Brian Ronholm who escalated widespread calls for FDA Commissioner Califf to fully incorporate this change in his next public update on FDA’s foods program redesign plan set for the end of the month. It is reprinted here with the author’s permission.

Califf won’t make fixes to help prevent another infant formula-level crisis
A fragmented and indecisive Food and Drug Administration (FDA) is struggling to escape widespread criticism for its major structural and governance problems exposed by the infant formula crisis. FDA’s issues are no secret, but neither are the solutions. In fact, a detailed blueprint on how to restructure the agency for success was presented to Commissioner Califf. But unfortunately, the redesign plan he announced falls short of the profound changes FDA needs to better protect consumers and accelerate getting safe, new food products to the market. Lack of bolder action ultimately jeopardizes public health. 

An external evaluation of the FDA’s food program was conducted by an independent, expert panel at the commissioner’s request. The final report showed immediate functional enhancements could be realized by appointing a fully empowered, specialized leader or “deputy commissioner for foods” with direct line authority over all key units of the foods program. Housing the research, policymaking, inspection, and enforcement components under one food authority will boost functional efficiency and provide much-needed accountability for the food program’s budget. But drastic improvements require revolutionary change. 

Despite broad support for the report’s recommendations, Califf’s initial “redesign” plan didn’t reflect its true substance even though it contained some of the right words. Instead, he signaled that a new “deputy commissioner” would possess watered-down managerial power compared to those who previously held such a role. Rather than unifying the entire food program under a single leader with direct line authority, the major organizations responsible for running food-related operations would still report directly to Califf under his plan. We’ve already seen a splintered structure like this fail. A diluted plan to fix it won’t deliver the full transformation FDA needs.  

In its current state, the commissioner’s plan fails to sincerely elevate the stature of the food program. It largely maintains the status quo. FDA’s apparent intent to write off resounding calls for bolder steps to fully empower an expert foods leader is frustrating as it is puzzling. The foods program is a distinctive part of the agency deserving of a structure and leadership model tailored to its mission – not one improved in name only. The organizational weaknesses that contributed to the infant formula crisis can only be resolved through more decisive action.  

FDA shouldn’t wait for another high-profile mishap that could cause sickness, and even death, to make its “redesign” plan more serious. Consumers deserve an FDA that takes every step possible step to keep structural issues from inhibiting its mission, so it can focus acutely on preventing public health risks. But what we heard from the commissioner puts much-needed agency modernization well out of reach.  

As research expands our understanding of human nutrition, the availability of information at the intersection of health and diet is accelerating changes in consumer behavior. From specialized diets like keto or paleo, to demand healthier convenient food options in grocery stores, to easy access to data on sensitive ingredients like gluten or sesame oil, informed consumers are driving the explosion of new food products on the market. It is, therefore, critical that the agency responsible for food safety match the swift pace of today’s evolving consumer preferences with timely decision-making on innovative products.   

At the end of the day, it’s consumers who will face the consequences if FDA refuses to truly shift away from its existing culture of indecision and inaction. The next public update on FDA’s foods program redesign plan should incorporate modifications that properly designate a deputy commissioner with the full authority needed to drastically improve functionality. FDA must acknowledge the robust record of widespread support from consumer organizations, industry, and state and local regulators – even backed in FDA’s requested third-party report – for this strong course of action. It’s time for FDA to do its job and do it right.  

About the authors: Roberta Wagner served nearly 20 years at FDA and as a top policy official at USDA. She is vice president of regulatory and technical affairs at the Consumer Brands Association, which represents nearly 2,000 iconic brands in the consumer packaged goods industry.  

Brian Ronholm is director of food policy for Consumer Reports, an independent, nonprofit member organization that works with consumers for truth, transparency, and fairness in the marketplace. He is a former deputy undersecretary for food safety at the U.S. Department of Agriculture and previously worked for Rep. Rosa DeLauro (D-Conn.)

The Center for Produce Safety (CPS) was formed as a public-private partnership, inviting all produce safety stakeholders – industry, research institutions, and regulatory and public health agencies – to engage with each other to fund science, find solutions and fuel change in fresh produce food safety. These diverse stakeholders make up our board of directors and our research program’s Technical Committee, sharing their collective knowledge to advance produce safety research and improve produce safety programs. Yes, this type of collaboration is a lofty goal – but now more than 15 years after CPS’s founding, it is a goal well on its way to being achieved. 

It has not always been easy.  Merriam-Webster’s dictionary defines the term silos as “an isolated grouping, department, etc., that functions apart from others especially in a way seen as hindering communication and cooperation.” This term is often used in frustration when groups are not working together. When CPS was founded in 2007, there were silos in the conduct of fresh produce safety research. Those silos existed for many reasons, including:  

• Some growers, packers, processors and shippers feared that research could cause unanticipated harm. For example, some were concerned their customers would leverage preliminary research results into buying requirements and restrictions without consideration of operational challenges. Some in the industry were similarly concerned that research might result in new regulations that would harm their businesses. As a result, research scientists were seldom able to conduct research in real-world production environments. 

• The result of this industry “silo” around research meant that many capable researchers did not have the insights into the operational aspects of the fresh produce production needed to create meaningful research objectives that address the complexities of the industry.  Further, scientists often do not collaborate across disciplines. (Have you been to a university campus recently? It is difficult to find parking, much less know everyone across all of a university’s research programs.)  

While the climb ahead of us is steep, produce safety silos are starting to crumble and progress is being made.

Since our founding, CPS has funded 226 produce-specific food safety research projects, spending $40 million at 46 institutions in five countries. We’ve learned much along the way.

When stakeholders participate in the development of research priorities, they will ultimately be more receptive to those results than if those questions were being driven or dictated by others. CPS makes a concerted effort to provide a safe, nonjudgmental environment for all produce safety stakeholders to have difficult, but constructive conversations about industry produce safety needs. This silo-busting collaboration is possible because we begin by respecting each other’s knowledge and perspectives. From there, growers, buyers, suppliers, and agencies can collaborate to define our most pressing produce safety questions and to call for and critically evaluate research proposals that will answer those questions. 

We have also learned that produce safety research doesn’t always provide one direct answer. While sometimes this is the case, more often research provides us with a myriad of information. Sifting through a research report can be daunting. But with help from the food safety community, we can parse out the learnings and how they may apply to individual business circumstances and ask better, more focused research questions in the future. 

We have learned we cannot always expect research scientists to tell us what we should know. They can explain the science, and in some cases the application of that science. But ultimately it is up to industry scientists and professionals to ensure that research results are evaluated thoroughly and benefits shared across the industry.

We use a variety of knowledge transfer tools to help industry learn about and apply CPS research findings to their businesses. This starts with our annual research symposium, a unique event where industry can gather to hear breaking research results firsthand from CPS-funded researchers, discuss the implications of the data and explore applications to our operations, all in a safe space. The rest of the year, our research database and updates on our projects are accessible 24/7/365 via CPS’s website, www.centerforproducesafety.org. 

Other key learnings we’ve gathered along the way include: 

• Recognizing a research need is only part of the challenge. Defining the researchable question that will provide our answers can sometimes be equally challenging. 
• More research is not always the answer to our questions.  Sometimes the question should be, why is what we know not being put to use?
• Research must be both scientifically defensible and industry applicable.
• We must educate scientists and industry. Industry engagement is imperative to research success. We cannot expect a research scientist to know the fresh produce industry and its intricacies. It is our responsibility to explain our industry to the scientists we are asking to study us. Similarly, industry must understand from scientists the criteria that make a project scientifically defensible. 

Fresh produce safety issues facing our industry remain complex — such as reoccurring outbreaks, emerging pathogens new to produce, and managing cross contamination risks in an ever-evolving supply chain that extends globally. The difference is that today, it is no longer unusual to find multiple industry members – including competitors – collaborating on a research project seeking answers. Nor is it unusual for producers to have a conversation with regulators about their collective scientific knowledge to further efforts on produce safety. As long there is a safe, nonpunitive environment to seek and share such knowledge, fresh produce food safety will continue to improve as the silos continue to crumble. 

About the author: Bonnie Fernandez-Fenaroli is executive director of the non-profit Center for Produce Safety. She works with CPS’s volunteer, multistakeholder board of directors and Technical Committee to bring to life CPS’s mission to fund science, find solutions and fuel change in fresh produce food safety. 

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Editor’s note: A coalition of organizations sent this letter to Xavier Becerra, the Secretary of the U.S. Department of Health and Human Services

Dear Secretary Becerra,

We write to express our concern about the problems in the Food and Drug Administration’s (FDA’s) Foods Program and the need for an organizational, structural, and cultural overhaul.

We represent a wide range of FDA stakeholders in the consumer community, the food industry, and among FDA’s state regulatory partners. We appreciate Commissioner Robert Califf’s recognition that significant overhaul is needed and his solicitation of external input as he considers changes.

However, many experts agree that the reform proposal the Commissioner announced on January 31 falls far short of what is required for FDA to succeed in its food safety mission because the proposed Deputy Commissioner role appears to lack the authority needed to implement and sustain the needed changes. We urgently request a meeting with you and your team to share our concerns and possible solutions before the Commissioner announces the next steps in his plan.

The problems in the FDA Foods Program were well documented in a comprehensive investigative report published in Politico in April 2022. In response to that report, the Commissioner asked a seasoned panel of experts convened by the Reagan-Udall Foundation to analyze the program’s deficiencies and recommend changes. The panel found and documented serious organizational, structural, and cultural obstacles to the program’s success and outlined many recommendations for change, including options for reorganizing the program to elevate and unify it and strengthen its internal and external accountability.

Importantly, every organizational option the panel provided called for unifying all elements of the program under a new deputy commissioner with direct line management authority and accountability for the program’s success. The Commissioner’s announced changes rejected that advice. While it included the deputy commissioner position, it failed to empower it with direct line management authority over FDA’s food-related field inspection force, which consumes over 60 percent of all FDA food resources and is crucial to the implementation of the Food Safety Modernization Act (FSMA). The Commissioner also excluded from the deputy commissioner’s direct authority elements of FDA’s Center for Veterinary Medicine that relate directly to food safety and FSMA implementation.

We advised the Commissioner of our concerns in the attached letter and met with him on this matter on February 14. Our group left with the sense that the Commissioner did not feel that direct line authority was needed but encouraged us to continue expressing our concerns.

We understand that organizational change can be difficult and often faces internal resistance, but the result of the Commissioner’s half step is that the Food Program will remain organizationally fragmented with a divided leadership structure. Extensive experience has shown that this structure is not sufficient in supporting FDA’s public health mission and will not contribute to badly needed cultural changes.

Thank you for your attention to this matter. We hope to be able to meet with you soon.

Sincerely,

American Frozen Food Institute
Consumer Reports
STOP Foodborne Illness
Association of Food and Drug Officials
Environmental Working Group
Western Growers
Consumer Brands Association
Internal Fresh Produce Association

cc: FDA Commissioner Robert Califf, Andrea Palm, Bruce Reed, Susan Rice

Dear Editor:

This letter is in reference to a recent Letter from the Editor in Food Safety News (“An independent food safety board is far better than anything FDA Commissioner does on his own”), dated January 29, 2023. As some may remember, I had the great privilege of serving as Undersecretary for Food Safety at the U.S. Department of Agriculture from 2001 to 2004. During that time, we faced several foodborne illness events and meat recalls due to contamination with E. coli O157:H7 (ground beef patties) and Listeria monocytogenes (ready-to-eat cold cuts), among others. To address these and other issues, we focused on ensuring that our inspectors were well trained in the science of the Hazard Analysis Critical Control Points system (HACCP), forming teams of auditors to ensure that plans were not only in effect at meat processing plants, but that they had been developed in a science-based manner. In fact, we made sure that all regulations we would issue would be based strictly on science and evidence, not speculation. As a result of our activities, the rate of contamination of ready-to-eat meat and poultry with L. monocytogenes dropped from 0.64% in 2005 to 0.33% in 2017 (Mamber, S.W., et al, 2020 J. Food Prot. 83(9):1598-1606), and illnesses due to E. coli O157:H7 decreased by 42%, reaching the CDC’s Healthy People 2010 Goals for foodborne illnesses due to this organism ahead of schedule (cdc.gov/mmwr, April 15, 2010).

During that time, there had been calls from various groups urging the formation of a single food safety agency, to include both the Food Safety Inspection Service (FSIS) which was under my authority, and the Food and Drug Administration (FDA), which was under the authority of the Commissioner of FDA. As Undersecretary, I was most proud of the fact that FSIS worked well with other agencies within USDA, such as the Animal and Plant Health Inspection Service (APHIS) and the Food and Nutrition Service (FNS), both of which had relevance to food safety. In addition, FSIS worked well with FDA, with then Deputy Commissioner Dr. Lester Crawford and I interacting frequently, as we were not only facing unintentional food contamination, but also the potential for bioterrorism acts in the wake of September 11th. It became evident that each agency served its purpose, as per the mandates that specific laws had provided, such as the Federal Meat Inspection Act for FSIS, and the Food, Drug & Cosmetic Act for FDA. It was also very evident that given the very unique authorities of each agency through very different laws, that we all needed to work well together. This was in fact what followed, with Dr. Crawford and I ensuring that the agencies we oversaw were well staffed with knowledgeable professionals, but also empowered to carry out their duties, obviating the need for a single food safety agency.

I think we can all agree that ensuring the safety of our food supply is an incredibly important activity that cannot be underestimated. It requires that the regulations that federal agencies like FSIS and FDA promulgate be based on science, and that these agencies be led through a structure that ensures proper supervision of the right number of well-trained staff so that said regulations can be rigorously enforced. Evidence shows that there have been some issues related to enforcement in the “food” portion of FDA, most recently demonstrated by the Abbott Labs infant formula incident. However, what we don’t need is the unnecessary upheaval of federal agencies, but rather to concentrate where the problems are, and then fix them.

This brings me to the point of this letter: that FDA does not need to be removed from the Department of Health & Human Services. Rather, that we should look to follow the FSIS model, an agency that is within USDA, with great connectivity to other agencies within that department, fully independent, fully empowered, yet well connected. Similarly, FDA needs to be split into two agencies, one for foods, and one for drugs and cosmetics, both remaining within the Department of Health & Human Services. Each agency would then be led by a presidentially appointed Commissioner. By remaining within HHS, both agencies would then be able to continue to work closely with each other, as they are both provided with authority from the same law, the FD&C Act, as well as with other entities within HHS such as the Centers for Disease Control. Importantly, the new “Foods Agency” would then be empowered to have its own structure, focused entirely on foods under its jurisdiction, just like FSIS has within USDA. This should translate into a better managed agency, able to respond to whistleblowers and to surveillance data much more quickly. Of course, adequate funding for such an agency is of primary importance, as long as it is efficiently designed as to avoid bureaucratic delays in developing, monitoring, and enforcement of its regulations.

Dr. Elsa A. Murano, Former Undersecretary for Food Safety at USDA
Director of the Norman Borlaug Institute for International Agriculture
President Emerita and Professor of Food Science & Technology
Texas A&M University

The 2023 Food Safety Summit, the premiere event for thousands of food safety professionals, has announced five pre-event certificate courses to be offered on Monday, May 8, 2023 at the Donald E. Stephens Convention Center in Rosemont, Illinois. Two FSPCA Certificate courses, Preventative Controls for Animal Food Training and the Foreign Supplier Verification Program, have been added to three returning courses including HACCP Training, Food Fraud Prevention, andCertified Professional – Food Safety (CP-FS) review course. The following are descriptions for these five pre-Summit courses: 

• NEW – FSPCA Preventive Controls for Animal Food Training – The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (referred to as the Preventive Controls for Animal Food, or PCAF rule) is in Title 21 of the Code of Federal Regulations (CFR) Part 507 (21 CFR Part 507). The PCAF rule is intended to ensure safe manufacturing, processing, packing, and holding of animal food products in the U.S.  This 20-hour class is held over 2.5 days and includes an exam.   Certificate of completion presented by FSPCA.

• NEW – FSMA FSPCA Foreign Supplier Verification Program – As audits are on the rise and regulations are being strongly enforced, it is more important than ever to know how to implement the requirements of the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals regulation of the U.S. Food and Drug Administration (FDA), and this workshop will do just that. This course is designed for U.S.‐based importers who meet the definition of “importer” in the FSVP rule, which includes those who own or are the consignee of food at the time of entry or, if no owner or consignee exists, the U.S. agent or representative of the foreign owner. It is also for others who have an interest in ensuring that the requirements of the FSVP rule are met, including brokers, exporters, foreign suppliers of food that will be exported to the U.S., persons/business owners who currently buy food from foreign sources, and representatives of foreign governments. This two-day course includes a certificate of completion presented by FSPCA.

• Certified Professional – Food Safety (CP-FS) Credential Review Course – This course was developed by industry experts from across the country to provide participants with a review of the knowledge and skills necessary to pass the CP-FS Credential Exam. It also provides a solid overview of food safety standards and practices. This course provides the knowledge and skills necessary to help ensure safe food in any retail environment – as a quality assurance or quality control manager, a facility manager, a food-safe chemical supplier, or as a regulatory inspector/investigator.  This two-day review course is presented by the National Environmental Health Association (NEHA).

• Food Fraud Prevention Workshop and Certificate Course – Food fraud prevention is one of the most urgent and misunderstood food industry topics. This workshop begins with an overview of the food fraud problem before quickly shifting from “how to catch food fraud” to “how to prevent food fraud from occurring in the first place.” Building upon that overview, the afternoon will shift to conducting the food fraud vulnerability assessment. This assessment is a requirement for the Food Safety Certifications such as BRC, FSSC22000, IFS, SQF and others. These standards are based on the Global Food Safety Initiative (GFSI) benchmark. The workshop ends with a focus on the Food Fraud Prevention Strategy and full implementation of a management system. This is a one-day course with a certificate provided by the Food Fraud Prevention Think Tank.

• HACCP Training –  This course covers information needed for writing a Hazard Analysis Critical Control Point (HACCP) Plan as required by USDA for FSIS-regulated meat, poultry, or egg products or for those producing foods under GFSI-format 3rd party audits requiring a HACCP certified individual to oversee their food safety plan. Participants will gain information for creating, implementing, and documenting a HACCP program.  This 20-hour class is held over 2.5 days and includes an exam.  Certificate provided by the International HACCP Alliance.

The pre-Summit courses include breakfast, lunch and breaks, books/training material and certificate. Multi-Day course registration includes access to the Food Safety Summit education sessions, exhibit hall, and networking functions during non-course hours. To take advantage of early bird pricing, click here, to register before Friday, March 31, 2023. 

The 2023 program will offer a wide range of topics impacting industry professionals including root cause analysis, leadership skills, advancements in sanitation, traceability, AI and data gathering, and much more. On Wednesday and Thursday from 10:30 am–2:30 pm, there will be dedicated Exhibit Hall time for attendees to learn about new solutions, engage in small group discussions in the Community Hub, attend free presentations by food safety experts in the Solutions Stages and in the Tech Tent, enjoy lunch, and network. For access to the full program and for attendee registration, visit  https://www.food-safety.com/food-safety-summit. 

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Significant resources have been invested in public health campaigns to reduce sodium intake to improve health, but dietary intake remains high, threatening safe eating habits. 

Guidance from public health authorities indicates we should consume less than 2,300 milligrams (mg) of sodium per day, but Americans average 3,400 mg daily. So, what options remain? It has been suggested that instead of encouraging North Americans to eat less sodium, reducing the level of sodium in our food supply could be a key strategy. 

A recent systematic scoping review of hundreds of studies was conducted to explore sodium reduction strategies such as sodium chloride removal or replacement, flavor modification, functional modification and changes to the physical structure of foods. 

Treading carefully is important when removing or substituting salt because of its role in baking, preserving, curing, thickening and in moisture retention, as well as taste. It’s used in a variety of recipes and preparations. 

Historically, sodium chloride salt was added to foods as a safety measure to prevent spoilage. Prior to refrigeration, advances in packaging techniques, and transportation infrastructure, salt was one of the best methods for inhibiting the growth and survival of undesirable microorganisms. 

Salt is an effective food safety tool because it reduces the water activity of foods. The water activity of a food reflects the amount of unbound water available for microbial growth. Adding salt to foods can also cause microbial cells to undergo osmotic shock, resulting in the loss of water from the cell and thereby causing cell death. Salt does remain in widespread use for preventing rapid spoilage, creating an inhospitable environment for pathogens, and promoting the growth of desirable micro-organisms in various fermented foods and other products. 

Today, few foods are preserved solely by the addition of salt. However, salt remains a commonly used component for creating an environment resistant to spoilage and inhospitable for the survival of pathogenic microorganisms in foods. For some foods, reducing the sodium content of the consumer product should not create food safety or spoilage concerns. Such foods include frozen products, products that are thermally processed to kill pathogenic organisms, acidic foods, and foods in which water activity remains low when sodium is removed. 

For other foods, reducing sodium content has the potential to increase food spoilage rates and the presence of pathogens. For these foods, product reformulation, changes in processing, and changes in handling may be required to ensure that the product has an adequate shelf life and to prevent pathogen growth. 

Foods using sodium as a method to retard microbial growth and survival present a reformulation challenge, since changing the sodium content alters water activity. Reformulation may involve many additional considerations related to pH and temperature. If such additional measures are not taken during sodium reduction efforts, the resulting products may not be stable. For example, in cured meats, reducing the sodium content could allow for rapid growth of lactic acid bacteria and action by proteolytic microorganisms, resulting in a product that spoils more rapidly. In other foods, pathogen growth — rather than spoilage — may become a concern. Thus, developing some guiding principles for sodium reduction strategies seems timely.

The researchers of the scoping review delved into hundreds of studies and concluded that, “The use of salt replacers was the most common method to reduce the sodium content of foods, followed by salt removal, flavor modification, physical modification, and functional modification.”

In order for sodium reduction to be successful, consumer acceptance must be maintained – as determined through sensory analysis. The scientists find that there is a solid base of studies on the technological aspects of removing sodium, but less on evaluation of consumers’ taste perceptions. “. . . there almost certainly exists a large collection of the effect of sodium reduction on the technological aspects of foods, but not every study will choose to include sensory analysis.” 

The research team recommends that additional studies focus on consumer responses to each preferred sodium reduction strategy. “Because consumers have their own personal preferences and beliefs guiding their food consumption, it will be vital to understand which approaches will be welcomed by the largest portion of the population.”

If changing the food supply is a priority approach for reducing sodium intake, consumer acceptance of revised recipes must also rise to the top in order for new food formulations to have a meaningful public health impact.

The study team is currently working to build on this report through an expert interview process, to capture sodium reduction knowledge and strategies not available in the public domain.  

The peer-reviewed article encompassed articles, book chapters and patents and was carried out by University of Illinois at Urbana-Champaign researchers in the Department of Food Science and Human Nutrition.

Further, it has led IAFNS to develop a publicly available database containing science and strategic information on sodium reduction. The new database compiles evidence-based strategies for sodium reduction organized by specific categories relevant to the food sector.

We hope to join other public health organizations in spreading awareness of this sodium reduction resource that taps knowledge from over 277 studies.

Check out IAFNS Sodium Reduction Science and Strategies Database here.

The study and database developed above were supported by the Institute for the Advancement of Food and Nutrition Sciences (IAFNS). Details of the study are posted on the Open Science Framework (see https://osf.io/szrxj/). 

About the author: Wendelyn Jones, PhD, is executive director of IAFNS, a 501(c)(3) science-focused nonprofit uniquely positioned to mobilize government, industry and academia to drive, fund and lead actionable research. 

TO:
Dr. Robert Califf Commissioner
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903-0002

We write to share our comments and suggestions regarding your next steps based on the analysis and recommendations from the Expert Panel convened by the Reagan-Udall Foundation, and request a meeting as soon as possible to discuss them with you.

As a diverse coalition of FDA stakeholders, we thank you for commissioning the Foundation’s independent expert review of the Human Foods Program in the Food and Drug Administration (FDA). The Expert Panel seriously considered the input it received from both external stakeholders and internal foods program employees in producing a candid report.

We believe the Expert Panel report the Foundation issued on December 6 accurately captures the problems involving the structure, leadership, culture, transparency, and accountability within the FDA’s foods program, all of which are preventing the agency from doing its best to protect consumers and enable industry to innovate. We also appreciate the Expert Panel’s conclusion that having a single leader who is empowered and accountable for the success of the foods program is central to its success; it is noteworthy that all of the panel’s options for structural change include this critical element. We also agree with the Expert Panel’s recognition that the inspection and compliance functions of the Office of Regulatory Affairs (ORA) needs to be integrated with the policymakers that reside in the FDA’s Centers.

We continue to believe that the option of placing an empowered food expert in a deputy commissioner position with line authority over all elements of a unified Human and Animal Foods Program is the critical element of a successful organizational and leadership structure. We also recognize that a range of options for doing this is on the table, all of which warrant discussion.

For example, while we think option E (an empowered deputy commissioner) is the simplest and most expedient way to achieve the needed structural and leadership change, Options A and B also deserve discussion and consideration. We do not consider Option C — the CFSAN director and a political appointee leading the foods program — to be viable because no one person would have the bandwidth to both manage CFSAN and provide management oversight of CVM, food elements of ORA, and possibly a new Center for Nutrition.

Moreover, under Option C, operational leadership of the program would remain divided and potentially politicized by an appointee in the commissioner’s office. Changing appointees and/or vacancies in the position would also be detrimental to the program. Finally, we do not consider Option D — relying on the commissioner and an advisor in his office to provide the sustained, integrative leadership the program needs — to be a viable option due to the tremendous competing demands on the commissioner’s time.

We urge you to announce your commitment to an empowered deputy commissioner model (Option B or E) in February, and name an expert food safety leader who could begin serving in that role immediately on an acting basis while deliberations and dialogue continue on how best to implement such a model. This would expedite FDA’s reform process while also balancing urgency and the need for further stakeholder dialogue. Formal reorganization of FDA will take time, but culture change can and should begin immediately.

We appreciate the sense of urgency reflected in your intent to announce a new vision for the Food Program by the end of January and a new structure by the end of February. However, we urge you to seriously engage external stakeholders – consumers, industry, and state and local partners – in genuine dialogue before announcing your decision.

The analysis and recommendations of the Expert Panel to establish the structure and leadership the foods program needs to be fully leveraged, and this can be accomplished more effectively through genuine dialogue with your stakeholders.

Thank you for your attention to this issue. We look forward to a meeting and further discussion with you as soon as possible.

Sincerely,

American Bakers Association
American Frozen Food Institute
Association of Food and Drug Officials
Center for Food Safety
Consumer Federation of America
Consumer Reports
Consumer Brands Association
Corn Refiners Association
Environmental Defense Fund
Environmental Working Group
FMI – The Food Industry Association
Global Cold Chain Alliance
Healthy Babies Bright Futures
International Dairy Foods Association
International Fresh Produce Association
National Confectioners Association
National Grocers Association
National Seasoning Manufacturers Association
Natural Resources Defense Council
North American Millers’ Association
Peanut and Tree Nut Processors Association
STOP Foodborne Illness
Western Growers

Editor’s note: The Lewis and Clark Expedition, commissioned by President Thomas Jefferson, mapped and explored the Louisiana Purchase and areas West from 1804 to 1806, including the area from the Missouri River to the Pacific Ocean.

They were on the edge of starvation in the Bitterroot Mountains during mid-September 1805.

The 34 members of the Lewis and Clark expedition were so hungry they began eating their own horses. They also supplemented the meat with canned “portable soup” on Sept. 14, 15, 16, 18, and 19 in that difficult year.

When Capt. Meriwether Lewis paid for canned soup in Philadelphia in May 1803, he could have never imagined his emergency food had a fair chance of killing all members of the expedition. This fact was largely dependent on whether the soup was boiled before consumption. To add to this difficulty, the emergency food was contained in lead canisters in which no oxygen could flow into the food.

This comprehensible ignorance by today’s standards was because science had yet to understand both germ theory and the negative health consequences of ingesting lead. In addition, scientists and food processors had no comprehension of the deadliest known food poison: botulinum toxin.

Reasonable persons believe we have advanced well beyond early 19th-century ignorance, and in many ways, we have progressed. However, in some ways we are regressing, much to the detriment of public health.

Botulinum is a potent neurotoxin toxin. It is created under low-acid, low-oxygen environments, and cannot be detected by sight, smell or taste. One tablespoon of purified botulinum toxin has the potential to kill all humans on Earth, if an antitoxin is not administered, usually within the first 48 hours of symptom onset. In the worst circumstance, the toxin can be neutralized if the food is boiled prior to consumption for at least ten minutes, and longer at mountain altitudes.

This fact may have saved the expedition. as Pvt. Joseph Whitehouse suggested in his journal on Sept. 15, “we melted Snow to drink & make portable Soup.”

In 1803, Lewis had Chef Francois Baillet create a thick paste, comprised of water, beef chunks, egg whites, and chopped vegetables, known as “portable soup.” Baillet likely learned his food canning method indirectly through the efforts of French Chef Nicholas Appert who developed his canning process from 1799 to 1809. Appert packed foods into glass bottles, corked openings, and submerged the bottles in boiling water for times ranging from seven to 120 minutes. Appert eventually won a prize of 12,000 francs for his efforts in 1810 from emperor Napoleon Bonaparte of France.

Napoleon wanted a way to nourish troops for military campaigns.

The soup Lewis bought would today be classified as a low-acid canned food. Similar high-risk canned foods, to which substances like vinegar are added, are classified as acidified foods. Both these foods are high-risk canned products, regulated by either the Food and Drug Administration (FDA) or the U.S. Department of Agriculture (USDA).

Which agency has authority over high-risk canned food depends on two factors: the most relevant is whether ingredients or products have been, or will be, subject to interstate commerce.

In the circumstance of the 2021 “Montana Local Food Choice Act,” the law bends over backward to avoid USDA authority for both ingredients and products. However, it only does the same for FDA products. In other words, it’s impossible to legally reason that local “homemade” commercial food products using nonlocal ingredients are outside FDA jurisdictional authority.

“Local” cannot also mean “nonlocal.” Worse, the law claims to be outside of consumer safety protections any reasonable person would expect from such homemade commercial foods.

One of the reasons for the extremely low number of incidents involving commercial foodborne botulism is that these foods have been subject to federal consumer safety standards.

If a state has no regulations or refuses to enforce regulations for high-risk canned foods, and the product includes interstate ingredients, the producer of that canned product is only exempt from the FDA’s emergency permit provision if they meet minimum standards. In such a circumstance, the FDA commissioner must investigate to determine whether to take emergency action on behalf of the public. Because most botulism cases involve homemade food, it’s highly unlikely any FDA commissioner would find the emergency permit provision would not apply to Montana’s commercial homemade food law.

According to surveillance data from federal authorities, in the lower 49 states, the majority of botulism cases are attributed to homemade foods. For example, the most recent data available for 2018 indicated there were 17 laboratory-confirmed cases. Of the 17 cases, nine were attributed to homemade foods.

But this botulism risk is acceptable to Montana state Sen. Greg Hertz, Gov. Greg Gianforte, and state health department director Charles Brereton, who refuses to legally challenge the law, despite its obvious interstate commerce issues because the risk outweighs their extreme antigovernment agenda, dictated to them by their “Americans for Prosperity” overlord. Moreover, let this column serve as public notice of the supremacy of federal law that Montana has disregarded through willful inaction.

I think Lewis and Clark — the embodiment of public service — would expect much more from government officials to protect public health than what is happening now in Montana.

Jeff Havens has been a registered sanitarian in six states during decades of public service, specializing in commercial food safety. He was the lead author for the 2015 rewrite of Montana’s retail food law and rules, which allows for the production of low-risk homemade foods. He is a current Montana Dept. of Health and Human Services worker but not an official spokesperson for the agency.

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Microorganisms need moisture, the right temperature, and just a little bit of time to grow. Some organisms such as yeasts and molds and microorganisms such as Salmonella are capable of surviving for long periods of time in dry environments and just a little moisture can be a tremendous catalyst. Once these pathogens begin to spread they wreak havoc on food production facilities, causing production shutdowns, recalls and foodborne illness outbreaks. It wasn’t until the late 1990s, that Salmonella was first identified in dry cereal, and the risk of microbial contamination in dry and low moisture food products was even recognized. Today, regardless of the processing environment, it is well understood that moisture, microbial growth and migration must be controlled. 

Moisture can enter dry food processing environments in a multitude of ways. Humidity and condensation are common culprits when adequate HVAC systems are not in place. Employees may also track water residue from wet to dry areas as they move about if donning and doffing controls are not in place. The misapplication of water during cleaning and sanitizing of dry environments is an obvious manner in which water can be introduced. Good Manufacturing Practice (GMP) per FDA’s 21 CFR 117 “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” can help to identify hazards for which prevention and correction strategies must be developed. 

But what about the risk of microbial spread encouraged by the very products intended to mitigate them? Effective cleaning and sanitizing in dry environments is a great concern, particularly considering most cleaning and sanitizing products on the market today are composed of primarily water. 

Whether cleaning food contact surfaces or flooring, in both wet and dry environments, pathogens like to hide in plain sight, in those pits and cracks that are difficult to see, clean and inspect. Moisture can encourage their adhesion to surfaces and microbial growth. In dry food processing environments the problem is particularly compounded as the dry material mixes with moisture to form a paste. “If you get water into a spice line it is a nightmare,” says Jared Torgeson, Business Development Manager at Pureline. Because of water’s risk, many food processors, regardless of the food processing environment’s tolerance for moisture, are turning to dry cleaning and sanitation practices for routine use.

“I think in general all segments of the food industry have begun to appreciate the importance of controlling moisture as an important aspect of controlling microorganism growth,” says Mirdamadi. It’s important to note that without a clean environment, sanitizing will be ineffective.

Cleaning in a dry food processing environment

In an ideal world, all equipment and facilities should be cleaned in the same manner. But, given the complexity of equipment design, facility layouts and surfaces and opportunity for cross contamination, particularly between wet and dry areas, robust cleaning protocols must be implemented specific to the environment.

Experts recommend always cleaning from the top down in dry environments using brushes and scrapers that loosen soils. Next, remove the loosened soils with a vacuum fitted with a HEPA filter or very controlled compressed air. Compressed air is typically a last resort because users must be cautious that the air isn’t merely blowing soil, microorganisms, and allergens from one area to the next. After all visible dirt has been removed, FDA-approved sanitizer can be used to wipe away any remaining residues. 

Once equipment is clean, perform a visual inspection, swab it and re-clean as necessary. Once cleaning is verified, it is time to sanitize. 

Dry sanitation

In the U.S., dry sanitizing of food contact surfaces requires an EPA registered food contact surface sanitizer but one that doesn’t introduce unnecessary moisture. If the sanitizer is approved, no rinse is required.

“The real challenge,” says Mirdamadi, of dry and low moisture environments “is sanitizing efficiently and effectively.” In wet environments the use of foamers can saturate surfaces, for instance, which is effective and thorough. But in dry environments, the available sanitizing methods are more arduous. “You can’t put dry sanitation solutions into a foamer,” he says of the need to eliminate the introduction of water.

In some instances a more thorough disinfection is required, such as a facility restoration after a known contamination event. In these instances, a gas solution that is able to permeate the entire room, reaching all surface areas, even those the eye can’t readily see, can be most effective. Chlorine dioxide generated gas, for example, resets and decontaminates the environment. “It permeates every nook,” adds Torgeson, “and provides peace of mind.” Generated onsite, use of chlorine dioxide gas is digitally monitored and logged to assure target concentrations are achieved over an eight-hour treatment. It can be used routinely or as a facility reset.

Addressing problem soils

Sometimes, soil can be particularly difficult to remove with only dry cleaning techniques. If water or steam is required to eliminate debris on equipment used in a dry processing environment it is best to disassemble and remove the necessary parts to a washroom where traditional wet cleaning techniques can be used. Before returning the newly cleaned and sanitized equipment back to the food processing environment everything must be completely dry to avoid encouraging microbial growth. 

In these cases in dry operations and after wet cleaning and sanitizing, it is a good practice to resanitize equipment once reassembled and in place using dry techniques. “During reassembling there is a risk of recontamination,” Mirdamadi suggests. “A second sanitation can be a valuable extra effort in these cases.”

Dry food processing environments have particularly unique needs when it comes to cleaning and sanitizing. “One of the benefits of chlorine dioxide gas is that it can be 100% effective,” says Mirdamadi. 

When every decision impacts safety, you’ll want to get it right.

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By Joe Reardon, Senior Director of Food Safety Programs, National Association of State Departments of Agriculture

The American Frozen Food Institute (AFFI) and the International Fresh Produce Association (IFPA), along with FMI – The Food Industry Association (FMI); the National Restaurant Association (NRA); and the National Association of State Departments of Agriculture (NASDA) recently hosted a Food Safety Forum aimed at discussing current detection methods, public health risk considerations, and regulatory policies affecting enteric viruses (i.e., Norovirus and Hepatitis A virus) and protozoan parasites, such as Cyclospora, in foods. 

The safety of the food supply is a high priority in the United States. Reports of foodborne outbreaks caused by microbial contamination of fruits and vegetables remain front page news. The presence of enteric viruses and protozoan parasites in the food supply continues to be of concern; however, these pathogens present unique detection challenges as they cannot be cultivated in the lab, unlike bacterial pathogens which can be cultivated. 

This issue has become more important as the U.S. Food and Drug Administration has placed an emphasis on determining the prevalence of these microorganisms in fruits and vegetables. An ongoing FDA frozen berries surveillance assignment for enteric viruses uses a molecular (RT-qPCR) test which detects a small fragment of the viral nucleic acid but cannot confirm the presence of the whole viral genome, or an intact virus particle. It also cannot determine whether the viral nucleic acid identified is infectious. Similarly, FDA began sampling select fresh herbs for the presence of Cyclospora cayetanensis, also based on a PCR method, due to the inability to use culture confirmation of this parasite. The FDA PCR method for Cyclospora also cannot determine infectivity.  

The forum
The forum was prompted by calls for increased surveillance and testing for these pathogens across the food supply chain, yet key criteria for what constitutes a positive test result are lacking.

This forum attracted more than 400 registrants from multiple sectors of industry, academia, and government. AFFI and IFPA provided an opportunity for an in-depth discussion of the existing science surrounding non-cultivable pathogen detection methods as well as the implications of using current PCR results without validation procedures for regulatory purposes. 

The programming included a presentation from Branko Velebit of the Institute of Meat Hygiene and Technology in Serbia on the difficulty of establishing global thresholds for enteric virus sample positivity given the vast array of assay parameters such as specificity, sensitivity, and limits of detection reflected by cycling threshold (Ct) values. Ynes Ortega with the University of Georgia discussed the complexity of detecting Cyclospora, specifically the human pathogen Cyclospora cayetanensis. 

Given the differences between these pathogens, scientists should be thoughtful when using current detection methods, and regulators need to use validated methods to ensure confidence in results. Furthermore, this session highlighted the need to establish appropriate sample positivity criteria if new policies, such as zero tolerance for findings of nucleic acid, are going to be the compliance standard used in regulatory surveillance programs.

The second panel was comprised of academic leaders, Lee-Ann Jaykus, North Carolina State University, and Lucy Robertson, Norwegian University of Life Sciences, who shared examples on the limitations of the existing data and knowledge of transmission of enteric viruses and parasites on foods compared to other pathogens. Jaykus and Robertson agreed that it is in the best interest of academia, regulators, and the food industry to acquire data to develop validated risk-based methods to best interpret PCR results, as a positive PCR result does not itself represent a public health risk. Jaykus emphasized the need to establish a risk assessment process, after a confirmed PCR signal, to support a regulatory action, if warranted. Both presenters agreed that appropriate risk-based science should drive policy. Without corroborative evidence, current methodologies can lead to unwarranted regulatory action.

The forum ended with a panel discussion on the public health risk implications of using current detection methods and interpreting results. Representing the National Association of State Departments of Agriculture, I was joined by Tim Jackson of the FDA, Dr. Neda Nasheri of Health Canada, Trevor Suslow of the University of California-Davis, and Sophie Zuber of the Nestle Research Center. This panel presented a robust discussion on the relationship between detecting viral RNA and infectious viruses, the role of modeling and risk assessment, and prevention strategies to control these non-cultivable pathogens. The panel agreed that efforts of academia, industry, and government should focus on prevention to mitigate the risk of food contaminated with enteric viruses or parasites.

Summary 
The food industry, academia, regulators, and the public support and expect our food supply to be safe. We also support the use of sound science supporting regulatory goals that accurately and objectively safeguard the food supply. New technological advances can help us to perform our responsibilities better; however, we also need to keep an open mind regarding what roles these new tools provide. When using these PCR methods, absent the ability to enrich and cultivate these organisms, it is currently impossible to confirm that the nucleic acid finding represents the presence of a viable pathogen. Several risk assessment approaches may be applied to augment the validation of potential positive PCR results. Support for PCR as a diagnostic tool exists; its value as a regulatory tool requires further discussion. 

The discussions that resulted from this forum were candid and compelling. If you missed the forum, you can watch the session recordings by clicking here. It is evident that differences continue to exist in approaches to enteric virus and parasite testing methodology and interpretation of results, and that we should work collaboratively to enhance the current understanding of the prevalence, risk, and prevention of enteric viruses and protozoan parasites in foods. Perhaps it is time for the food industry, academia, and regulators to consider a holistic approach to provide data that is accurate, reliable, and useful to protect the safety of consumers.

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By Jim O’Hara

For the first time in many years, the Food Program at the Food and Drug Administration is under serious scrutiny by Congress and the press, most visibly regarding the Abbott infant formula safety and shortage controversy.  

In April, however, a broad coalition of food industry trade associations, consumer groups, and FDA’s state regulatory partners raised much more extensive concerns about the program’s shortcomings stemming from its fragmented organizational structure and divided leadership.  The coalition called for organizational unification of the program under a deputy commissioner with the expertise and authority to provide the integrative leadership and accountability the program needs.  

Then, in July, FDA Commissioner Robert Califf announced that an external group of experts will conduct “a comprehensive evaluation” of FDA’s Human Foods Program to address “fundamental questions about the structure, function, funding, and leadership of the program.”   

Most recently, a group of former FDA food safety program officials has put forward a road map for a new governance structure for this expert panel to consider. 

Yet, some current and former leaders of FDA seem to be clinging to the organizational status quo, as though they believe the earth is flat and that the Federal Food, Drug, and Cosmetic Act of 1938 and FDA’s traditional management paradigm for food safety remain sufficient today.

But, in fact, the globe has been circumnavigated. Earth has been viewed from space.  Most importantly, the Food Safety Modernization Act (FSMA) of 2011 has been passed and calls for a new paradigm of food safety.

The food safety concerns of 80 years ago focused on the adulteration of food products and consumer fraud by unscrupulous businesses. Food production was mostly domestic. From those facts, a culture evolved at FDA: catch the bad guys, present solid scientific evidence of their wrongdoing in court, and go after the next bad guy.

Today, we routinely eat foods grown, harvested, and processed from around the world.  Our understanding of the risks of microbiological contamination possible in food production and its impact on our health compared to 80 years ago is the difference between the Apollo program and the Model T.

A new culture of prevention needs to spring from those facts — one in which all elements of FDA’s Food Program are pulling together in the same strategic direction to keep food safe. FSMA demands no less of FDA because FSMA demands so much more. 

FSMA expanded FDA’s food safety mission far beyond its historic focus on U.S.-based food manufacturing facilities to encompass for the first time more than 100,000 fresh produce farms in the U.S. and overseas and many tens of thousands of foreign manufacturers and their U.S.-based importers and feed importers. 

FSMA directed FDA to create new programs for defending the food and feed supply from intentional adulteration, improving the traceability of food, and establishing a new “national integrated food safety system” in partnership with state food regulators. 

Congress mandated in FSMA that human food, pet food, and feed for food animals all be regulated under a common holistic framework of regulatory standards for prevention, making obsolete the thick wall that currently separates the parts of FDA regulating human and animal food. 

Finally, to make FSMA a success, FDA’s Office of Regulatory Affairs (ORA), which conducts vital inspection and enforcement activity, requires a cultural transformation of its own. It must move from inspection and reaction to safety problems as ends in themselves to an ethos of public health prevention, pursued now on a global basis.  

ORA must work seamlessly, flexibly, and in full transparency with the Food Program’s science and policy leaders. And it must be accountable to them for implementing new strategies that incentivize prevention and the implementation of best practices across the food system.

To think that FDA’s fragmented and siloed management structure can accomplish all this is to believe that 16^th century galleons are capable of the discoveries of the James Webb Space Telescope.  

As the former FDA food safety officials have proposed in their road map for the future, a single, authoritative focal point for leadership of the overall Food Program in the person of a deputy commissioner is needed, along with a unified executive team that together can elevate the priority and power of the Food Program within FDA and enable the program to speak with a unified voice and consistent message. This will strengthen the Food Program in its competition with the medical product programs for FDA resources and externally in engaging stakeholders and state regulatory partners.    

By not recognizing and acting on these changes and needs, FDA’s leadership and its allies are in danger of sailing FDA’s food safety mission right off the edge of the world.

About the author: Jim O’Hara was FDA’s Associate Commissioner for Public Affairs from 1993 to 1997 and managed the public affairs rollouts of the Nutrition Facts label and the Hazard Analysis at Critical Control Points (HACCP) initiative for seafood. From 1997 to 1999, he was the Deputy Assistant Secretary for Health and served on the Clinton Administration’s inter-departmental committee to coordinate food safety efforts.  He also served as Executive Director of the Produce Safety Project, an initiative of The Pew Charitable Trusts to build support for FDA to establish produce safety regulations.

By Jayne Roth, M.P.H, REHS
Rimkus Consulting Group, Inc.

At the end of 2021, a survey fielded by the National Restaurant Association showed that 78 percent of operators said their restaurants did not have enough employees to support customer demand. Understaffing is not only an economic issue, but also a food safety issue. With fewer staff, many safety and operating procedures get shorted in exchange for service expectations. This has the potential to increase risks of foodborne illnesses (FBIs).

Going out to dinner with family shouldn’t cause an impending feeling of danger. However, did you know there are more than 250 types of pathogens that can cause foodborne illness? The Centers for Disease Control and Prevention (CDC) publishes statistics each year of FBIs, such as hospitalizations, and deaths, and these numbers are in the thousands. FBIs can happen anywhere at any time, including one’s own home. However, restaurants or businesses serving food have a higher expectation for FBI control and understaffing because of Covid-19, which can result in an increased risk and additional liabilities to their food safety managers and the establishments themselves.

It is important to realize that FBIs can happen to anyone and can have varying degrees of severity. An individual suffering from something they ate can be devastating. It may result in missed days of work, which for some families means that they can’t afford to buy food for dinner this week or are rendered unable to care for their children. Or it may result in a several days’ stay in a hospital, among other outcomes.

The fear of contracting COVID-19 has caused millions of customers and employees to stay at home, resulting in a massive decrease of dollars spent on entertainment, gas, and food. This double-edged sword has reduced the numbers of customers going out to eat and, in turn, resulted in plummeting sales. Restaurants either can’t stay in business, or they reduce staff to do so. The number of restaurant employees dropped by 2.2 million from 2019-2020. Unfortunately, many restaurants attempt to maintain status quo, but with a potential price to those who eat at their establishments. We are discovering the hard way that the side effects of COVID-19 may be indirectly causing FBIs from the circumstances at hand.

The value of the restaurant industry in 2020, after being adjusted because of COVID-19, was $659 billion ($240 billion less than projected). Restaurant managers and owners are trying to stay open and staffed, which is commendable. However, a survey conducted by the Michigan Restaurant and Lodging Association found that 88 percent of respondents are operating with inadequate staffing. The public health sector has seen thousands of illnesses occur for decades, and much needed new laws and regulations that keep up with current science have been adopted to change industry practices. 

A restaurant with an eight-page menu, for example, shouldn’t operate with a skeleton crew unless they have made other adjustments. Adequate staff is needed to operate the kitchen in a manner that is conducive to a controlled situation and ensures that corners are not cut on food safety practices. 

It sounds simple, but the risks understaffing poses to public health need to be addressed quickly. Labor violations, such as not giving employees time to eat or take a break, can be common in the restaurant industry. These violations usually go unpunished since workers cannot afford to refuse shifts, speak up for their rights, or even take sick time. Unfortunately, FBIs are occurring in understaffed foodservice establishments. Those employees who do continue to work may not have the knowledge or experience needed to control food safety risks in the kitchen. However, having knowledge of food safety is not a predictor of proper food handling, especially with time constraints, poor training, and a general lack of resources. 

One of the biggest contributors to foodborne illness outbreaks is human error. Often, these errors are unintentional. For example, an employee is rushing or forgets to take the internal temperature of the meat being cooked and inadvertently serves undercooked (potentially harmful) hamburger. Or they place packages of raw poultry on a high shelf in the walk-in cooler, and raw juices drip on (and contaminate) the ready-to-eat foods below. Or they leave a delivery of refrigerated products out in the hot sun for hours, making them unsafe and unusable. These human errors are magnified when restaurants are understaffed, leaving even less time to follow critical food safety procedures.

Cutting corners, working while ill, and lack of general food safety knowledge can lead to devastating outcomes. In 2018, a British pub chef admitted to disregarding food regulations and indicated he was rushing while preparing Shepherd’s pie, which contributed to poor cooking, cooling, and reheating steps necessary to control potential pathogen survival or growth in food products. As a result, one person died and 30 people were sickened. The chef was ultimately given a four-month jail sentence, community service, and a large fine. 

These situations have the potential to end up in litigation. If a restaurant does have insurance, it may not be sufficient to cover medical costs of ill customers. Foodservice establishments must be compliant with applicable rules and regulations to protect their reputation and, ultimately, their pocketbook.

During FBI investigations, I have had heart-wrenching conversations including one with a young husband whose wife was on life support because of complications from E. coli O157:H7. I’ve had conversations with a mother whose son was lying on the bathroom floor screaming as he suffered from vomiting and diarrhea simultaneously after consuming a ‘healthy shake.” The list could go on and on. Ignoring proper food safety procedures has proven to be devastating.

 The solution sounds easy, right? Do not operate with inadequate staff. But what determines “inadequate staff?” I can surmise that deciding to close or reduce staff is one of the most difficult decisions for a manager or owner to make. Businesses are condensing their menus, which is a positive approach, as well as decreasing hours of operation and decreasing available tables. Evaluating food processes to build-out food safety risks by partnering with a food safety expert can decrease steps, save time, improve efficiency, and reduce food safety hazards. If there is an alleged exposure, then working with a qualified food safety expert/consultant, can help in the exposure identification, response, and investigation of claims related to food, food packaging, and processes. These investigations can include:

• Auditing food safety procedures at restaurants and manufacturing facilities
• Investigating food damage claims related to product safety and product quality
• Identifying causation of food microbial contamination as well as physical contamination of food products
• Evaluating compliance in food industry regulations regarding of standards of care 
• Investigating food allergen allegations
• Crisis management response to food-related incidents such as illnesses, recalls, aseptic sampling, public health considerations, and communication messaging
• Assisting in environmental sampling following positive tests by regulatory agencies

COVID-19 has provided numerous challenges to the food service industry, but none that cannot be addressed with proactive measures and intentional planning. Many of these challenges are molding the industry for the future. By understanding how these challenges could impact food safety, we will be designing a more resilient industry in the future.

Footnotes

 Restaurant job growth remained sluggish in September, National Restaurant Association, October 2021. https://restaurant.org/education-and-resources/resource-library/restaurant-job-growth-remained-sluggish-in-september/

² Burden of Foodborne Illness: Findings. Centers for Disease Control and Prevention. https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html#:~:text=Burden%20of%20Foodborne%20Illness%3A%20Findings.%20CDC%20estimates%20that,are%20hospitalized%2C%20and%203%2C000%20die%20of%20foodborne%20diseases.

³ 2021 State of the Hospitality Industry Report: Technology Trends, the Future of Restaurants and More. Lightspeed. October 2021. https://www.lightspeedhq.com/blog/state-of-the-hospitality-industry/

⁴ RESTAURANT LABOR SHORTAGE: WHY ARE COMPANIES STRUGGLING TO FIND WORKERS? 360 Training. https://www.360training.com/blog/restaurant-labor-shortage

⁵ 90 percent of state restaurants, hotels are understaffed as industry struggles to survive https://www.fox2detroit.com/news/90-percent-of-state-restaurants-hotels-are-understaffed-as-industry-struggles-to-survive

⁶ RESTAURANT LABOR SHORTAGE: WHY ARE COMPANIES STRUGGLING TO FIND WORKERS? 360 Training. https://www.360training.com/blog/restaurant-labor-shortage

⁷ Assessing Factors Contributing to Food Safety Culture in Retail Food Establishments. FOOD PROTECTION TRENDS | AUGUST 2012 https://www.foodprotection.org/files/food-protection-trends/Aug-12-Neal.pdf

⁸ Chef sentenced after deadly shepherd’s pie strikes down 32 people with food poisoning, killing one. Ben Chapman. December 2021. https://www.gbnews.uk/news/chef-sentenced-after-deadly-shepherds-pie-strikes-down-32-people-with-food-poisoning-killing-one/170302

References

1. Restaurant job growth remained sluggish in September, National Restaurant Association, October 2021. https://restaurant.org/education-and-resources/resource-library/restaurant-job-growth-remained-sluggish-in-september/
   
2. Burden of Foodborne Illness: Findings. Centers for Disease Control and Prevention. https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html#:~:text=Burden%20of%20Foodborne%20Illness%3A%20Findings.%20CDC%20estimates%20that,are%20hospitalized%2C%20and%203%2C000%20die%20of%20foodborne%20diseases.
3. 2021 State of the Hospitality Industry Report: Technology Trends, the Future of Restaurants and More. Lightspeed. October 2021. https://www.lightspeedhq.com/blog/state-of-the-hospitality-industry/
4. RESTAURANT LABOR SHORTAGE: WHY ARE COMPANIES STRUGGLING TO FIND WORKERS? 360 Training. https://www.360training.com/blog/restaurant-labor-shortage
5. 90 percent of state restaurants, hotels are understaffed as industry struggles to survive.https://www.fox2detroit.com/news/90-percent-of-state-restaurants-hotels-are-understaffed-as-industry-struggles-to-survive
   
6. RESTAURANT LABOR SHORTAGE: WHY ARE COMPANIES STRUGGLING TO FIND WORKERS? 360 Training. https://www.360training.com/blog/restaurant-labor-shortage
7. Assessing Factors Contributing to Food Safety Culture in Retail Food Establishments. FOOD PROTECTION TRENDS | AUGUST 2012. https://www.foodprotection.org/files/food-protection-trends/Aug-12-Neal.pdf
8. Chef sentenced after deadly shepherd’s pie strikes down 32 people with food poisoning, killing one. Ben Chapman. December 2021. https://www.gbnews.uk/news/chef-sentenced-after-deadly-shepherds-pie-strikes-down-32-people-with-food-poisoning-killing-one/170302

About the author: Jayne Roth, MPH, REHS, is Senior Food Safety Consultant at Rimkusin Portland, OR. She has more than 25 years of experience in the food industry, working in both the government sector and with the food safety programs of large companies such as Walmart and Amazon. Her experience includes local and state jurisdictions, working closely with State Infectious Disease Teams to mitigate large foodborne illnesses. She is well-versed in food safety regulatory compliance and the regulatory structure of U.S. public health jurisdictions and served as the Illinois U.S. FDA Food Standardization Officer. Roth was instrumental in the adoption of food regulations at federal and state levels as part of the U.S. FDA Model Food Code. She holds a master’s in public health with an emphasis in microbiology.

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Dear Dr. Henney: 

The undersigned coalition appreciates the opportunity to submit comments to the Reagan-Udall Foundation as part of its review of the foods program at the Food and Drug Administration (FDA). It has become evident in recent years that the foods program is in need of a significant culture change that would allow for a focus on illness prevention with improved governance, accountability, and transparency. 

The review panel is likely aware of the April 25 letter signed by many of the groups represented in these comments that highlighted the structural, governance, and performance problems in the FDA foods program and its effect on the ongoing implementation of the Food Safety Modernization Act (FSMA) and the execution of the New Era of Smarter Food Safety blueprint.

The success of these, and all, initiatives depend on all major foods program units – the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA) – working together seamless with their state partners and with a common strategic direction, clear priorities, sound resource management, and internal accountability. Success also requires transparency and robust engagement with industry, consumer groups, state associations, and other stakeholders. 

As part of our letter, we urged FDA Commissioner Robert Califf to create an empowered deputy commissioner for food position that would lead a unified foods program. This position would have direct line authority over all major program components, including CFSAN, CVM, and the relevant components of ORA. 

The need for reforms within the FDA foods program is extensive and will not be solved by the appointment of an empowered deputy commissioner position alone. However, it would bring focused leadership and accountability, and a unified structure that clearly establishes internal roles and responsibilities and strengthens the program’s ability to dialogue effectively with its many internal and external stakeholders. The empowered deputy commissioner and unified structure would also allow for streamlined decision-making and swift responses that would benefit all stakeholders, both in urgent matters and for daily operations.

Finally, this structural reform would enable enhanced transparency across the program, including: clearly documenting where resources are invested within the foods program through a transparent and consistent methodology; engaging in the open sharing of non-proprietary information, both internally and with external stakeholders; and publishing the analyses that form the basis of regulatory decisions. 

While we recognize that CVM is excluded from your review, we are concerned that this exclusion demonstrates FDA’s unwillingness to address difficult internal issues involving structure and accountability, and could be an attempt to influence this panel’s recommendations. It also demonstrates a lack of understanding of how the food system works. Virtually every element of CVM’s program relates in some way to the food system, including the animal drug approval program, which mainly applies to human food animals, and the regulation of animal feed, which affects both human and animal health. Excluding CVM from this review increases the potential that this panel’s final report and recommendations will be incomplete. 

We appreciate your consideration of these comments and the panel’s overall work on this critical review of the FDA foods program. 

Sincerely,

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Every five years, Congress reauthorizes the Farm Bill, a wide-ranging piece of legislation that affects every part of our food system. The next Farm Bill should reflect your values and build on your administration’s actions to date to reduce economic inequality, bridge the nation’s racial divides, end hunger, confront the climate crisis, improve nutrition and food safety, and protect and support farmers, workers, and communities. 

Such a Farm Bill should:

Ensure the Safety of Our Food Supply – Thousands of people in our country die every year from foodborne illness and millions more are sickened by pathogens in meat, poultry, produce, and drinking water. Recent food safety failures have highlighted gaps in our food safety net that place consumers at unacceptable risks from pathogens. Your Farm Bill must do more to address pathogens that originate on factory farms and to make the U.S. food supply safe for everyone.

President Biden, the undersigned organizations call on you to demand a transformative Farm Bill that fully reflects these values, and that you can be proud to sign. 

Sincerely,

 A Better Balance

 Academy of Nutrition and Dietetics

 Access East

 AFL-CIO

 Agricultural Justice Project

 Agriculture and Land-Based Training Association (ALBA)

 A Growing Culture

 Alabama State Association of Cooperatives

 American Grassfed Association

 American Federation of Government Employees, Local 3354

 American Federation of State, County and Municipal Employees (AFSCME)

 American Indian Mothers Inc.

 American Sustainable Business Network

 Association for the Study of African American History (ASALH Rochester)

 Association of State Public Health Nutritionists

 Appetite For Change

 Broadway Community, Inc.

 California Climate & Agriculture Network (CalCAN)

 California Environmental Voters

 California FarmLink

 Castanea Fellowship

 Center for Food Safety

 Center for Science in the Public Interest

 Center for Wellness and Nutrition (Public Health Institute)

 Certified Naturally Grown

 City Harvest

 Climate Crisis Policy

 Coalition of Immokalee Workers

 Coastal Enterprises, Inc.

 Coming Clean

 Community Alliance with Family Farmers (CAFF)

 Community Food Advocates

 Community Involved in Sustaining Agriculture (CISA)

 Compañeras Campesinas

 Consumer Federation of America

 Cultivate Charlottesville

 Detroit Food Policy Council

 Earthjustice

 Economic Policy Institute

 Environmental & Public Health Consulting

 Environmental Working Group

 Equity Advocates

 Fair Food Network

 Fair World Project

 Family Farm Defenders

 Farm Action

 Farm Aid

 Farm to Table – New Mexico

 Farmers Market Coalition

 Farmworker Association of Florida

 Farmworker Justice

 Fertile Ground

 Food & Water Watch

 Food Animal Concerns Trust (FACT)

 Food Bank of Central and Eastern NC

 Food Chain Workers Alliance

 FoodCorps

 Food for the Spirit

 Food Insight Group

 Friends of the Earth

 Friends of the Mississippi River

 GC Resolve

 Georgia Foundation for Agriculture

 Georgia Organics

 Glynwood Center for Regional Food and Farming

 Good Food For All Coalition

 Government Accountability Project – Food Integrity Campaign

 Grazing Reform Project

 Green America

 Groundwork Center for Resilient Communities

 Hand, Heart, and Soul Project, Inc.

 Health Care Without Harm

 HEAL (Health, Environment, Agriculture, Labor) Food Alliance

 Hempstead Project Heart

 Illinois Stewardship Alliance

 Institute for Agriculture and Trade Policy

 International Brotherhood of Teamsters (IBT)

 Iowa Environmental Council

 Iowa Interfaith Power & Light

 Johns Hopkins Center for a Livable Future

 Kansas Black Farmers Association

 Kansas Rural Center

 Land Loss Prevention Project

 Land Stewardship Project

 La Semilla Food Center

 League of Conservation Voters

 Los Jardines Institute

 LunchAssist

 Maine AFL-CIO

 Marbleseed

 Michigan Food and Farming Systems

 National Association of Pediatric Nurse Practitioners

 National Black Food & Justice Alliance

 National Council for Occupational Safety and Health

 National Employment Law Project

 National Farm to School Network

 National Latino Farmers & Ranchers Trade Association

 National Sustainable Agriculture Coalition

 National Young Farmers Coalition

Natural Resources Defense Council

 Nebraska Appleseed

 NETWORK Lobby for Catholic Social Justice

 New Orleans Food Policy Action Council

 Northeast Organic Dairy Producers Alliance

 Northeast Organic Farming Association-Interstate Council

 Northeast Organic Farming Association of New Hampshire (NOFA-NH)

 Northeast Organic Farming Association of New York (NOFA-NY)

 Northwest Center for Alternatives to Pesticides

 Nourish Colorado

 Office of Kat Taylor

 Ohio Ecological Food and Farm Association

 Oklahoma Black Historical Research Project, Inc.

 Oregon Climate and Agriculture Network

 Oregon Tilth

 Organic Farming Research Foundation

 Organic Seed Alliance

 Oxfam America

 Ozark Akerz Regenerative Farm

 Pasa Sustainable Agriculture

 Phi Global Farms

 Pineros y Campesinos Unidos del Noroeste / Northwest Tree-Planters and Farmworkers United

 (PCUN)

 Pinnacle Prevention

 Pesticide Action Network

 Plant Based Foods Institute

 Post Carbon Institute

Progress Michigan

 Public Justice

 Rebirth Inc.

 RegeNErate Nebraska

 Resilience Project

 Retail, Wholesale and Department Store Union

 Restaurant Opportunities Centers (ROC) United

 Rowan Food and Farm Network

 Roots of Change

 Rufty-Holmes Senior Center

 Rural Advancement Foundation International-USA (RAFI-USA)

 Rural Coalition

 Savanna Institute

 Sierra Club

 Slow Food USA

 Small Planet Institute

 Socially Responsible Agriculture Project

 Society of Behavioral Medicine

 Sooner Food Group

 Soul Fire Farm Institute

 Springfield Food Policy Council

Student Action with Farmworkers

 Sustainable Farming Association

 Sustainable Food Center

 Sustainable Food & Farming Program, UMASS Stockbridge School of Agriculture

 Sustainable Iowa Land Trust (SILT)

 The Farmers B.A.G.

 The Georgia Farm to School Alliance

 The Land Institute

 TomKat Ranch Educational Foundation

 Toxic Free North Carolina

 Trust for Public Land

 unBox

 Union of Concerned Scientists

 United Food and Commercial Workers International Union

 Venceremos

 Virginia Association for Biological Farming

 Wallace Center at Winrock International

 Wholesome Wave

 Wild Farm Alliance

 Women, Food and Agriculture Network

 Women’s Voices for the Earth

 Worker Justice Alliance

 Working Landscapes

 Workplace Fairness