Steve Ardagh
Beltway Beat

Normalization of Deviance: The Real Lesson of This Summer’s Cyclospora Outbreak

By Steve Ardagh
No Comments
Steve Ardagh

The Outbreak

By now most of us have seen the numbers. As of this week, the CDC has confirmed nearly 2,000 cyclosporiasis cases tied to a single multistate outbreak; state-by-state totals reported independently put the real figure well over 20,000. It is, by any measure, one of the largest outbreaks of its kind on record.

Food Safety Lawyer, Bill Marler wrote something last week that stuck with me more than the case counts did. He pointed out that the FDA had flagged this exact risk before, at the same corporate family, at a different facility, thirteen years earlier, after a 2013 Cyclospora outbreak. The agency’s own environmental assessment recommended the company test its water and re-evaluate its produce wash step. According to Marler’s reporting, there is no public record that verification ever happened.

Thirteen years passed. Nothing catastrophic occurred in the interim. Until this year, when it did, at a scale few outbreaks reach. That is not a story about something being missed. It is a story about something being known, and quietly stopping being treated as a risk, because nothing visibly bad happened for a long time. There is a name for that pattern, and it comes from a very different disaster.

What Challenger actually teaches

In 1986, the Space Shuttle Challenger broke apart 73 seconds after launch. The cause was O-ring seals that failed in cold weather. What made it a scandal, rather than just a tragedy, is that engineers had flagged O-ring erosion on multiple previous flights. Each time, the shuttle launched anyway, and nothing catastrophic followed.

Sociologist Diane Vaughan, studying the disaster afterward, coined a term for what happened next: normalization of deviance. The process by which a known deviation from a safety standard gets quietly reclassified as acceptable, not because anyone decided it was safe, but because it kept not causing a disaster. The risk didn’t disappear. It just stopped being treated as one.

The term has since become standard vocabulary in aviation safety, nuclear safety, and patient safety literature, precisely because the pattern keeps recurring: a known risk, documented, unresolved, tolerated because the bad outcome hasn’t happened yet… until the day it does. 20,000 or more bad outcomes in this case, to date!

The version of this sitting in the glove industry right now I run a food-safety glove company, and I think the glove industry has a normalization-of-deviance problem, and it’s been in the public record for two years without creating change.

In 2024, a peer-reviewed study in the Journal of Food Protection tested 2,800 food and examination grade gloves across 26 commercial brands. From the paper – “around 50% of samples contained fecal indicator organisms.” “Frank and opportunistic pathogens were identified on tested gloves, including recognized fecal indicators, enterotoxigenic strains of Bacillus cereus and B. anthracis along with the presence of Listeria monocytogenes, Clostridoides difficile, Staphylococcus aureus, Pseudomonas aeruginosa, and Streptococcus pneumoniae…” As with Cyclospora, the origin was likely contaminated water – in this case at the manufacturing plants in SE Asia.

All samples were stated as “FDA Compliant.” FDA’s compliance pathway for gloves (21 CFR 177) tests whether the raw material chemical content is safe to touch food. It does not test whether the glove itself is sanitary, even though FDA’s own manufacturing standard (21 CFR 117.10(b)(5)) requires gloves to be “intact, clean, and sanitary.”

That’s not a hidden gap. It’s published, peer-reviewed, and two years old. We raised it formally with the Conference for Food Protection, the body that reconciles exactly this kind of regulatory contradiction; the Council declined to act, ruling it outside the Conference’s scope, and it won’t be reconsidered until 2027. We also petitioned FDA directly in November 2025 to address the underlying material standard for vinyl gloves. Both are public record.

No known outbreak has been publicly attributed to a contaminated glove yet. Under normalization of deviance, that fact means precisely nothing about whether the risk is real. It means the industry hasn’t yet had its version of a cold morning in January. The absence of a headline is not evidence of safety.

It’s the condition under which a known risk gets tolerated, right up until it isn’t.

What this isn’t, and what it is We need to be careful here, because it would be easy to overreach. We are not claiming Cyclospora has been found on gloves; it hasn’t, and the biology makes that unlikely. This isn’t a claim about one pathogen. It’s a claim about a pattern: known risk, no verification requirement, tolerated by default until something forces the question.

What this outbreak actually demonstrates, more than any specific pathogen, is how expensive that pattern gets once it resolves. Tens of thousands of illnesses, a supply chain under scrutiny, a regulator facing hard questions about what it knew and when. Nobody sets out for this. It happens by default, when a known and documented risk is left unverified long enough.

Food manufacturing, processing, and service all use gloves as a deliberate barrier against exactly this category of contamination. That’s the entire point of the product. The question worth asking isn’t whether your gloves are FDA compliant. It’s whether anyone has verified they are sanitary. For most gloves on the market today, the honest answer is probably not, and nobody has checked.

Maybe we will have to wait years for something to happen as a result of a contaminated glove. But the fact remains that the glove that is supposed to be a barrier to the fecal-oral contamination route may in fact turn out to be the bridge.

Sources

Publisher’s Platform: The FDA closed the 2024 romaine E. coli outbreak without naming Taylor Farms… – Bill Marler, Food Safety News, July 29, 2026

Publisher’s Platform: The Fifty-State Cyclospora count is 20,927 this morning. Bill Marler Investigation Update: Cyclospora Outbreak, July 2026 – CDC

Journal of Food Protection, 2024 – Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination.

 

Women in Food Safety

Why Authenticity Wins in Food Safety: 5 Leadership Lessons from Kelly Stevens

By Kim Ring
No Comments

At Women in Food Safety, our mission has always been to elevate voices, share hard-earned wisdom, and build a community where professionals can thrive. Recently, we had the privilege of hosting our June gathering*  with Kelly Stevens, Director of the Global Food Safety Center of Expertise at General Mills.

With a remarkable 30+ year career spanning laboratory microbiology, intense manufacturing plant roles, and global corporate leadership, Kelly joined us to share the raw, honest milestones of her journey. For food safety professionals, her insights that we’ve boiled down to five tips, offer a powerful masterclass in leadership, navigating industry barriers, and owning your career path. 

1. Stop Self-Eliminating

Early in her 22-year tenure at General Mills, Kelly completed three manufacturing plant roles across New Jersey, Georgia, and Missouri. Despite initial personal resistance, she now credits those boots-on-the-ground operational roles as career-defining moments that built her technical credibility.

Many professionals, particularly women, fall into the trap of only applying for roles if they check every single box. Kelly’s advice? Don’t say no to yourself. When you choose not to pursue an opportunity, you remove yourself from consideration entirely.

Applying to that job, even if you feel underqualified, builds organizational visibility and could provide you with useful professional feedback. Kelly also suggests updating your resume annually. Not because you are actively job-hunting, but to track your skill development and benchmark your capabilities against the external market.

2. Admit When You’re Wrong

For the introverts in our community, Kelly’s transition into leadership is incredibly relatable. Identifying as a strong introvert, she admitted she initially became a people leader reluctantly. She learned to deliberately practice extroverted behaviors for professional effectiveness, ultimately finding that leading a team toward a common goal is the most rewarding part of her work.

As she started to develop her own leadership style, she learned a few tactics for fostering psychological safety and trust within technical teams. First, always admit when you’re wrong.

Openly acknowledging mistakes models vulnerability and signals to your team that it is safe to speak up.

Long pauses have a similar effect. When asked to make a difficult food safety or operational decision, Kelly takes a moment to think, with an intentional, extended pause before speaking. This explicitly invites dissenting opinions, allowing her to evaluate whether new input should pivot the team’s direction.

3. Resist Conforming to the Norm

Early in her career, Kelly was often the only woman in the room. She recalled receiving coaching to hide family photos, avoid personal topics, and conform entirely to dominant male norms, even resorting to reading hunting magazines just to find common ground with colleagues.

Today, her stance has shifted completely to authenticity over conformity. Trying to be anyone but yourself is unsustainable. The industry is changing for the better, and female leadership should be increasingly visible at every level of the organization.

4. Create Habitual Networking Skills

Building a network is the most valuable asset you can accumulate, but crowded industry conferences can feel overwhelming. Kelly recommends coming up with a list of questions to ask people before the conference starts to ease awkward moments and keep the conversational spotlight on the other person.

At large events, deliberately sitting at the busiest table is the best bet for introverts. It reduces the intense pressure of one-on-one small talk while still embedding you in the room’s energy. 

Finding your voice in a conference setting can be tough at first, but one place to start practicing could be your company’s conference room. Kelly once used a coaching exercise where she tracked and reported every single meeting when she chose to speak up versus when she held back. This practice helped Kelly create a habit of contributing in group settings.

5. Master the Art of Purposeful Prioritization

One of the most freeing moments of the session came when Kelly shared advice from her own mentor, Judy. The concept of daily ” work/life balance” is a myth. Trying to distribute your time and energy equally every single day creates immense, unnecessary pressure.

Instead, look at it as purposeful prioritization or “harmonizing.” True harmony means making deliberate choices based on what matters most right now, whether that is a critical plant audit today or a family milestone tomorrow.

Ultimately, Kelly’s journey reminds us that the most effective leadership doesn’t come from fitting a mold, but from breaking it. By applying to that high-level job, embracing your authentic voice, and choosing purposeful harmony over the exhausting myth of ” work/life balance,” you stop just navigating the food safety industry and start shaping its future as a leader. Even if you’re an introvert, you don’t need permission to lead; you simply need the courage to show up as yourself.

*Women In Food Safety Monthly Gathering is a welcoming virtual conversation where women across the global food safety community come together to connect, learn, and grow. Each month features an inspiring guest leader or industry expert who shares their career journey followed by an interactive Q&A and open discussion. Whether you’re a student, emerging professional, or seasoned leader, these gatherings provide a supportive space to build meaningful connections to empower one another to thrive in food safety.

Editors Note: The Food Safety Consortium and Food Safety Tech supports WIFS and for six years has published a dedicated Women In Food Safety column.

Women in Food Safety Networking Breakfast at the Food Safety Consortium
USDA Logo
Beltway Beat

USDA Risks Becoming Irrelevant on Food Safety

By Brian Ronholm
No Comments
USDA Logo

As concerns grow over its response to the screwworm situation in Texas, there’s a food safety issue flying under the radar at the U.S. Department of Agriculture that also may impact consumers more directly.

Last December, USDA announced a delay in the implementation of a rule that would declare Salmonella an adulterant in not-ready-to-eat breaded stuffed chicken products. In terms of food safety oversight proposals, CR described this as being easier than picking low-hanging fruit. USDA claimed the reason for the delay was that currently available test methods have accuracy limitations.

However, even the USDA’s own evidence doesn’t support the claim. In May 2024, USDA actually confirmed the existence of a validated test that had no false-positive issues. Now, USDA officials say that they became aware of inaccuracies in that test—but didn’t release any data to support their assertion. Consumer Reports recently wrote the USDA to express concern over this lack of transparency and to request any data supporting the claim of testing inaccuracies.

If USDA fails to move forward with this rule, it runs the risk of being perceived as being irrelevant on food safety oversight and beholden to industry interests. While the department’s food safety leadership likes to repeatedly emphasize that they use a science-based and data-driven approach to policy making, consumer advocates worry that these statements are meaningless if they don’t translate into policy initiatives that aim to prevent foodborne illness.

This Op-Ed was reprinted with permission from Consumer Reports Food Policy Insider. To subscribe, send an email to:  foodpolicyinsider@cr.consumer.org

Manufacturing productivity, efficiency
Ask The Expert

The Hidden Layer of Repetition Series, Article 2 of 5

By Azure Edwards, M.S.
No Comments
Manufacturing productivity, efficiency

The conversation about what food safety costs a business tends to organize itself around visible events such as recalls, regulatory actions, and the dramatic and documentable failures that generate headlines and liability. Those numbers are significant: the average direct cost of a single recall exceeds $10 million before accounting for lost contracts, brand damage, and the long recovery that follows. But framing food safety cost around its most visible expressions misses where most of the financial opportunity lives. For most organizations most of the time, the larger cost is arriving as a pattern distributed across departments, absorbed into operating budgets, and carrying the fingerprints of governance conditions that the business has the capacity to address.

Consider what that looks like in practice. A food manufacturing operation had built its reputation on exceptional customer responsiveness: rapid turnaround, flexible scheduling, willingness to accommodate last-minute requests. Production runs were regularly adjusted to meet customer needs, and the disruption that followed was absorbed as the normal cost of doing business. However, each unplanned changeover carried downstream consequences: allergen controls, sanitation verification, testing, documentation, and lost production time. Compliance teams were under growing pressure to reduce testing and verification just to keep pace- an option that was already strained, and realistically unachievable. When the cumulative impact of a full year’s reactive scheduling decisions was translated into financial terms — labor hours, changeover time, testing and verification activities — the analysis revealed hundreds of thousands of dollars in avoidable annual cost traced to misaligned decision-making upstream rather than inefficiency on the floor. Leadership, once they could see it in those terms, acted. The frequency of testing didn’t change. Visibility into the downstream impact that scheduling inefficiencies were having on operations, as it turned out, was all that solution needed.

This case illustrates the mechanism directly. The financial loss was accumulating on a reliable cycle, distributed across production scheduling, labor costs, and operational friction that had been normalized as the price of flexibility. This is the same structure of most food safety-related financial loss: rework that has become a line item in the production plan because the underlying process hasn’t been stabilized, product holds representing days of inventory in unresolved disposition, absorbed overtime, investigations and management conversations about recurring problems that were documented but not yet diagnosed at their source, and institutional knowledge walking out with the people who were personally compensating for known system gaps. Research in lean manufacturing has identified what practitioners call the “hidden factory.” It is the covert rework, workarounds, and compensating effort that can consume 20 to 40 percent of a plant’s capacity without appearing in any formal accounting of cost. Food safety governance conditions are one of its most consistent generators, and one of the most accessible sources of recovery.

Decision latency makes this visible in the most financially legible way. When a product disposition decision is clear — when the authority behind it is structurally supported and the criteria for release are already defined — the decision reaches the right person with the right information and resolves before it becomes a disruption. The financial impact shows up in inventory turns, in cash flow timing, in the production schedule that ran as planned because someone could act without first finding someone who could. Leadership reading those numbers sees operational performance. What produced it was governance clarity, and it returns something better with every cycle where it is stable.

The reason these gains stay invisible as governance gains is structure. Rework belongs to operations. Holds belong to quality. Overtime belongs to workforce. Turnover belongs to HR. Each category has its own budget, reporting line, and owner while the upstream condition generating all of them simultaneously sits in none of those buckets individually. Fifteen years of preventive controls investment has produced something many organizations are positioned to use more fully: a record of operational performance detailed enough to begin reading these costs as a pattern with a common origin rather than as isolated inefficiencies belonging to separate departments. That reorientation is available, and the infrastructure for it already exists.

The financial logic of that reorientation is rather specific. When structural conditions are addressed rather than cycled through, inventory clears faster, institutional knowledge stays in the building, corrective work stops repeating itself, and decisions move because the authority behind them is unambiguous. Technology accelerates that speed further when the authority structure is already clear and a real-time hold notification reaches someone who can act on it rather than someone who has to find someone who can.  Those are margin improvements that live inside the systems already in place, accessible through the organizational clarity that allows those systems to function at their intended capacity. The changeover cost that became visible when someone finally translated it into financial language had always been there as potential recovery. Once leadership could see it, the decision took care of itself.

That shift from absorbing cost to locating its source builds the operational foundation that growth demands. Structural conditions that are addressed at manageable scale stay manageable. Left unaddressed, they compound. And when growth or supply chain challenges arrive, what the system has been carrying becomes what the system has to carry further.

Manufacturing productivity, efficiency
Ask The Expert

The Hidden Cost of Repetition

By Azure Edwards, M.S.
No Comments
Manufacturing productivity, efficiency

The conversation about what food safety costs a business tends to organize itself around visible events such as recalls, regulatory actions, and the dramatic and documentable failures that generate headlines and liability. Those numbers are significant: the average direct cost of a single recall exceeds $10 million before accounting for lost contracts, brand damage, and the long recovery that follows. But framing food safety cost around its most visible expressions misses where most of the financial opportunity lives. For most organizations most of the time, the larger cost is arriving as a pattern distributed across departments, absorbed into operating budgets, and carrying the fingerprints of governance conditions that the business has the capacity to address.

Consider what that looks like in practice. A food manufacturing operation had built its reputation on exceptional customer responsiveness: rapid turnaround, flexible scheduling, willingness to accommodate last-minute requests. Production runs were regularly adjusted to meet customer needs, and the disruption that followed was absorbed as the normal cost of doing business. However, each unplanned changeover carried downstream consequences: allergen controls, sanitation verification, testing, documentation, and lost production time. Compliance teams were under growing pressure to reduce testing and verification just to keep pace- an option that was already strained, and realistically unachievable. When the cumulative impact of a full year’s reactive scheduling decisions was translated into financial terms — labor hours, changeover time, testing and verification activities — the analysis revealed hundreds of thousands of dollars in avoidable annual cost traced to misaligned decision-making upstream rather than inefficiency on the floor. Leadership, once they could see it in those terms, acted. The frequency of testing didn’t change. Visibility into the downstream impact that scheduling inefficiencies were having on operations, as it turned out, was all that solution needed.

This case illustrates the mechanism directly. The financial loss was accumulating on a reliable cycle, distributed across production scheduling, labor costs, and operational friction that had been normalized as the price of flexibility. This is the same structure of most food safety-related financial loss: rework that has become a line item in the production plan because the underlying process hasn’t been stabilized, product holds representing days of inventory in unresolved disposition, absorbed overtime, investigations and management conversations about recurring problems that were documented but not yet diagnosed at their source, and institutional knowledge walking out with the people who were personally compensating for known system gaps. Research in lean manufacturing has identified what practitioners call the “hidden factory.” It is the covert rework, workarounds, and compensating effort that can consume 20 to 40 percent of a plant’s capacity without appearing in any formal accounting of cost. Food safety governance conditions are one of its most consistent generators, and one of the most accessible sources of recovery.

Decision latency makes this visible in the most financially legible way. When a product disposition decision is clear — when the authority behind it is structurally supported and the criteria for release are already defined — the decision reaches the right person with the right information and resolves before it becomes a disruption. The financial impact shows up in inventory turns, in cash flow timing, in the production schedule that ran as planned because someone could act without first finding someone who could. Leadership reading those numbers sees operational performance. What produced it was governance clarity, and it returns something better with every cycle where it is stable.

The reason these gains stay invisible as governance gains is structure. Rework belongs to operations. Holds belong to quality. Overtime belongs to workforce. Turnover belongs to HR. Each category has its own budget, reporting line, and owner while the upstream condition generating all of them simultaneously sits in none of those buckets individually. Fifteen years of preventive controls investment has produced something many organizations are positioned to use more fully: a record of operational performance detailed enough to begin reading these costs as a pattern with a common origin rather than as isolated inefficiencies belonging to separate departments. That reorientation is available, and the infrastructure for it already exists.

The financial logic of that reorientation is rather specific. When structural conditions are addressed rather than cycled through, inventory clears faster, institutional knowledge stays in the building, corrective work stops repeating itself, and decisions move because the authority behind them is unambiguous. Technology accelerates that speed further when the authority structure is already clear and a real-time hold notification reaches someone who can act on it rather than someone who has to find someone who can.  Those are margin improvements that live inside the systems already in place, accessible through the organizational clarity that allows those systems to function at their intended capacity. The changeover cost that became visible when someone finally translated it into financial language had always been there as potential recovery. Once leadership could see it, the decision took care of itself.

That shift from absorbing cost to locating its source builds the operational foundation that growth demands. Structural conditions that are addressed at manageable scale stay manageable. Left unaddressed, they compound. And when growth or supply chain challenges arrive, what the system has been carrying becomes what the system has to carry further.

Biros' Blog

Food Safety Fate

By Rick Biros
1 Comment

How often do you talk to strangers? For many, not too often. It has become very easy to avoid talking to people. For example, most people in a crowded hotel elevator either look at their phones, listen to their noise cancelling headphones or silently watch the progress of the elevator’s decent waiting for the doors to open. Yet, chance encounters with strangers can make life interesting and sometimes be impactful.

Two weeks ago, on the morning of the last day of our Food Safety Hazards Conference in St. Louis, while descending down in a crowded but silent hotel elevator. A women noticed my wife’s Food Safety Hazards Conference badge and asked Beth about the conference. The women remarked she used to volunteer for STOP Foodborne Illness. I asked, “I know STOP. Why were you volunteering?” As the elevator came to the lobby floor and the doors opened, we took the conversation into the lobby where she told us that her daughter had died of e-coli and shared some of the details of their tragedy. I gave her my business card and asked if we could reconnect in the near future.

Shortly before I was about to deliver the opening remarks at the conference, I received an email that read “My name is Dana and we met at the Hilton in Downtown St Louis and this is my daughter Kayla that passed away from Ecoli in 2007. It was nice to visit with you and here is her story.”

Kayla’s story was outlined in a letter Dana read at a U.S. Congressional hearing asking them to make the Food Safety Modernization Act law. Here it is:

Kayla Boner, 1993 – 2007

Every day, I ask myself, “Why did this have to happen?”  We put so much faith in the food on our shelves, only to find out one day that the safeguards needed to protect us are not there.  Because our food safety system has been reactionary instead of preventive for too long, I watched my healthy teenage daughter endure excruciating pain.  I was helpless.  There was nothing I could do.

Before the fall of 2007, Kayla loved to play basketball and softball.  She was incredibly social and enjoyed hanging out with a great group of friends.  She was full of life.  I don’t think there was a person who knew her who didn’t love her right away.  I distinctly remember Kayla’s 14th birthday — October 22, 2007.  She was thrilled because she could, at long last, get her learner’s driving permit.  Kayla, giddy with excitement, peppered my cell phone with calls until I agreed to drive her to the local department of transportation to take her test.  Watching Kayla become an independent young woman was thrilling. 

After a successful visit to the D.O.T it was time to get new contact lenses.  While at the optometrist she began complaining of serious stomach pains. Thinking this was nothing more than the stomach flu we decided to go home.  The next day, Kayla had not improved.  That evening Kayla woke up with bloody diarrhea.  The next day, she was admitted to Pella Community Hospital.  Kayla’s condition only got worse.

A week later, after countless tests, the physicians of Pella Community Hospital confirmed Kayla had contracted an E. Coli 0111 infection. Shortly after, Kayla’s kidneys shut down.  Requiring dialysis, she was transferred to Blank Children’s hospital in Des Moines, Iowa.

A few more days had passed when she woke up with a smile on her face.  She looked over and said “Mommy I am sorry.” 

Perplexed as to why a child who had spent days in agony would feel the need to apologize for anything, I asked why.

“Because I kept you up all night,” Kayla responded.

 “Sweetheart, that is what mommies do — and I love you” I said. At that very moment I remember hoping this was the beginning of the positive breakthrough for which we were desperately hoping.

“I love you too” were the last words my child ever spoke.

On Friday November 2nd, Kayla’s blood pressure spiked to dangerous levels. Doctors ran into her room trying everything they could muster to bring Kayla back to us. At 10:00 that morning, after seizures and many rounds of dialysis, Kayla’s 14 year old body couldn’t take it anymore.  She was gone.

I came to this hearing in an effort to tell you all how important it is that we put in place effective policies that spare other parents the horror I have experienced. Enactment of the FDA Food Safety Modernization Act is one such step but, for it to work, we need all of the regulations finalized as soon as possible.

Kayla dreamed of one day becoming a pediatrician. If this new law is implemented and enforced, I believe Kayla will get her wish.  She truly will be saving children’s lives.

Instead of doing my usual opening remarks to start the conference, I read the letter to the attendees and there was not a dry eye in the audience. Kayla’s sad but powerful story certainly hit home and if nothing else added motivation to an already passionate group of food safety professionals. For the rest of the conference, we kept coming back to Kayla’s story reminding us of why we do what we do.

Was this random hotel elevator connection fate or divine intervention? I don’t know. What I do know is because Dana was willing to talk to a stranger, she was able to share her daughter’s story to an audience of food safety professionals and now to you. Hopefully, as the food safety and quality community, we all can help support Kayla’s dream by saving children’s lives.

Women in Food Safety

Self-Care for the Safety-Savvy Woman: Why Taking Care of You Protects the World

By Kim Ring
No Comments

The professional landscape for women in food safety is one of intensity, high stakes, and constant motion. Between managing complex global supply chains, navigating regulatory changes, and often balancing a demanding personal life, it is easy to feel “stressed, tired, and overwhelmed”. This is the reality Joan Menke-Schaenzer, Chief Quality Officer at Van Drunen Farms and a newly appointed board member for Women in Food Safety, addressed in her recent powerful webinar.

Her message was a vital call-to-action for every woman in our industry: in a world full of noise, we must find our own quiet by prioritizing self-care and making it a deliberate, non-negotiable habit. Often mistaken as a luxury, self-care is truly a fundamental resource that can enable you to stay passionate about your work and effectively protect public health as a warrior of food safety.

The Vicious Cycle of Imposter Syndrome and Exhaustion

One of the most insidious challenges Joan addressed is imposter syndrome, which is a sinking feeling that you don’t belong or are not good enough or qualified enough for your role. While this negative self-talk feels like a professional challenge, Joan suggests that it is often a critical sign that you are not instituting proper self-care.

“When you are running ragged, and you’re tired, and you haven’t eaten or you haven’t slept, the negative voice in your head becomes much louder.”

Joan Menke-Schaenzer, Chief Quality Officer at Van Drunen Farms

To combat this, Joan recommends a two-pronged approach. First, label and compartmentalize the negative self-talk, acknowledging it as simply what you are telling yourself (not the truth), and put it aside. Focus on being nothing other than yourself, knowing that you are strong, smart, and that you bring value. Second, develop a feasible self-care routine to minimize factors that amplify your inner critic, such as sleep deprivation, dehydration, and lack of exercise.

Imposter syndrome tends to rear its ugly head when you are making a major career transition or stepping into a new role. Joan was faced with this when she decided to make the pivot from working on the quality side of food manufacturing to becoming the Operations Business Manager for the snacks division at Kraft.

“Suddenly, I had product P&L responsibility and I had to pivot my focus from quality to being responsible for both cost and quality. I moved into what I would call a business-focused mindset, which is a really important mindset to have as a quality professional as well.”

Joan enjoyed her time working at Kraft for 19 years until she started noticing signs that her work/life balance was shifting. Between having faxes sent to her hotel while on family vacation, and her daughter recognizing the voice of Kraft’s VP of Quality when answering the phone, Joan knew it was time for a change.

This challenge of balancing work, family, while still making time for yourself, is structural and a more common burden for women to bear as the natural caretakers.

“Women are often programmed to take care of others first, forgetting to take care of themselves in the process.”

Building a Disciplined Self-Care Program

Self-care for a busy executive isn’t a spa day—it’s a disciplined, daily routine. Joan emphasizes that she follows a written self-care program religiously every day, stressing that consistency is key. Her personal routine offers simple yet profound starting points:

Strategic Reading and Reflection: Every morning, Joan wakes up, has her cup of coffee, and reads food safety news, including recalls from the FDA and USDA. This practice slows her down, keeps her “on top of her game,” while allowing the mental space to ask herself: “What can I learn from that?”

External Perspective and Movement: She walks four miles a day, rain or shine, with a group of people who follow very different career paths- from nurses, to educators, and more. This community provides fresh air, sunshine, and a powerful perspective that everyone is dealing with similar struggles.

Partnering for Care: Self-care is not a solitary effort for women with partners and children. Joan suggests working with your partner to create a “circle of care for each other,” dividing responsibilities so both individuals can prioritize their own well-being. This shared commitment leads to greater confidence and ultimately, less negative self-talk.

Remembering the True Purpose of Your Job

The foundation of food safety is purpose. For Joan, it’s her “calling,” but when stress is high and patience wears thin, it can be easy to forget why you are doing it. Joan’s impressive career includes roles at Kraft Foods, Walmart, ConAgra Foods, and McDonald’s, and after decades working in the food world, her passion for food safety remains strong. When one of the webinar attendees asked her how she keeps that spark alive amid industry ups and downs, she encouraged everyone to remember the end goal – to protect people’s lives.

To drive this message home, Joan shared a conversation with a nurse friend who sees people struggling with their health every day. “She told me, you’re helping more people stay alive by producing safe foods.” This comparison to the medical world is a powerful way to frame the impact of your work.

“You are not just managing data or fixing roofs. Although these are important technical tasks, remember that you are a life-saver.” By internalizing this perspective and connecting it to the real human impact of outbreaks and recalls, you can sustain the courage needed to fight for quality and safety.

In short, to be a strong leader and advocate in food safety, you must first be an advocate for yourself. A deliberate, consistent commitment to self-care is the best defense against burnout, the loudest silencer of imposter syndrome, and the fuel that keeps your passion for protecting public health alive.

Editors Note: The Food Safety Consortium and Food Safety Tech supports WIFS and for six years has published a dedicated Women In Food Safety column.

Women in Food Safety Networking Breakfast at the Food Safety Consortium
Food fraud
FST Soapbox

Harnessing AI can help to ensure safe food for consumers across the US and beyond

By Wesley Wilson
No Comments
Food fraud

With consumer confidence in the safety of US food hitting a 13-year-low last summer, there is clearly work to do for consumer goods companies. There are multiple drivers for this loss in confidence, including concerns about insufficient government regulation, fears around foodborne illnesses and contaminants, and a rise in the number of food and beverage recalls.

Given that four in 10 Americans say clearer information about food safety practices would improve their confidence, brands are well positioned to regain momentum by proactively demonstrating how they safeguard consumers.

For the food industry, safety is the cornerstone of consumer trust. Without clear commitments to safety, food companies face a consumer base – including previously loyal customers – that may take their business elsewhere. In this digital age, consumers have access to more product news and information than ever before. The widescale need for robust food safety procedures has never been clearer.

The food sector is already using AI to optimize its supply chains, reduce waste and improve demand forecasting. Now, pioneering companies are also using AI for food safety processes. Its capabilities are significant – including switching safety approaches from reactive to proactive, using data-driven systems that focus on real-time pathogen detection, predictive risk analysis, and automated quality control. Computer vision can be harnessed to inspect contamination, AI-driven sensors can be used for microbial detection, and machine learning can analyze supply chain data to prevent recalls.

The potential for AI to be harnessed is substantial: several AI food safety startups are now partnering with regulatory bodies to co-develop compliance-ready platforms, blurring the line between enforcement and innovation.

However, while some high-profile food companies are jumping on rapid innovation to lead the charge, take-up across the sector remains limited, with less than 30% of global food manufacturers adopting AI for food safety processes. Even though manual systems are no longer efficient for today’s supply demands, paper-based recordkeeping largely prevails. This means that companies reluctant to embrace digitization are leaving themselves exposed to risk.

One of the key barriers is cost. Many businesses struggle to quantify the return on investment for AI safety initiatives, making it hard to justify high initial expenditure. But this approach comes with its own price. According to one study, the business cost of a food recall averages around $10 million – and in 23% of cases, the cost exceeds $30 million.

These enormous sums include assembling crisis management teams, issuing recall notifications, retrieving contaminated products, and conducting investigations to prevent future reoccurrences. But they’re only the tip of the iceberg, as further expenses such as legal fees and lost sales add to the financial burden. Reputational damage is harder to measure, but its impacts are no less severe, as rebuilding consumer confidence is a costly and intensive process, often taking years to build back trust.

AI systems can mitigate these risks, and for a fraction of the cost of an expensive food safety incident. One case study of a collaboration between Walmart and IBM Food Trust, for example, shows how AI was able to reduce the time required to trace the origin of contaminated lettuce from seven days to just 2.2 seconds. Such rapid traceability means companies can pinpoint and remove only affected batches, preventing widespread recalls that waste huge volumes of food and cost – potentially – millions.

AI offers benefits beyond safety management, too. Automation can negate administrative and time-intensive tasks within product development, creating capacity to strengthen product portfolios, elevate brand reputation and deeper consumer connections – heightening confidence alongside solid safety performance.

Consumer trust is the cornerstone of a food company’s success – but it’s never been easier to lose it. Amid global uncertainties, volatile supply chains, increased consumer awareness and a growing focus on health and wellbeing, food safety needs to be a paramount priority.

Harnessing innovation to improve food safety is one of the topics discussed at the Global Food Safety Initiative (GFSI) Conference, in Vancouver, B.C. last month. Of course, AI and tech are not a magic solution. Their impact depends on how they are implemented, and a commitment to the ethos that food safety is everyone’s business.

AI systems empower companies to deliver safety excellence smoothly, positioning them as trusted, reputable brands. Those that continue to rely on fallible safety systems risk events that could cost them their reputation forever.

Beltway Beat

Achieving Goals: Integrating the Fragmented United States Federal Food Safety System into a Food Protection System

By Allen R. Sayler, Benjamin J. Reading, Ph.D., Jason Bashura, MPH, R.S., Mehrdad Tajkarimi, DVM, MPVM, Ph.D.
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The United States (U.S.) food protection system is fragmented across federal, state, and local jurisdictions, resulting in duplication, inefficiency, and systemic failures that undermine public health and erode consumer trust. Foodborne pathogens such as Listeria, Salmonella, and E. coli do not respect institutional boundaries, yet responsibility for oversight is divided among more than 15 federal agencies, 75 state entities, and thousands of local jurisdictions, operating under more than 30 laws and 70 interagency agreements. This structure has proven incapable of reducing the persistent burden of foodborne illness in the U.S. The Centers for Disease Control and Prevention (CDC) estimate one in six Americans is affected annually, causing 10 million illnesses, 53,000 hospitalizations, and more than 900 deaths.

The term food protection, in use since at least 1924, conceptually unifies food safety, defense, authenticity, and infrastructure protection. However, the lack of an integrated federal entity has perpetuated disjointed responses. The 2025 recall of chicken fettuccine alfredo meals—linked to 17 illnesses, 16 hospitalizations, three deaths, and one fetal loss (as of this date)—illustrates the shortcomings of the system. Oversight was split between the Department of Health and Human Services (DHHS) Food and Drug Administration (FDA), which regulated the non-meat components, and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), which oversaw the chicken ingredient. Despite involvement from CDC, the outbreak was not contained in time to prevent fatalities. Similarly, the 2024 deli meat Listeria outbreak, responsible for 10 deaths and 61 illnesses, highlighted the failure of FSIS to enforce corrective actions despite documented ongoing sanitation-based violations. These preventable events underscore the limitations of the current model.

The Government Accountability Office (GAO) has repeatedly called for consolidation—in 2005 and again 20 years later in 2025—emphasizing that inefficiencies, regulatory conflicts, and siloed data hindering effective food protection, resulting in preventable public health impacts. Reports also document how FSIS’s 6,500-employee continuous inspection program expends enormous resources without measurably improving outcomes. Decentralized data management further impedes trend analysis, predictive modeling, and risk-based decision-making that could anticipate and prevent outbreaks.

A unified federal food protection entity would provide structural and scientific coherence, resulting in the desired outcomes described herein. By consolidating regulatory authority, streamlining enforcement, and centralizing data, such an entity could accelerate response times, enhance accountability, and foster consistent risk-based regulation. Integrating modern technologies such as artificial intelligence and predictive analytics would strengthen surveillance, while harmonized training and inspections would maximize public health protections and reduce duplication and industry burden. Examples from Canada and the United Kingdom—both of which have lower per-capita illness rates—demonstrate the effectiveness of nationally unified food protection systems.

Congressional recognition of these systemic weaknesses has spurred legislative proposals in 2025 to establish a single food protection authority. This initiative reflects both scientific necessity and policy urgency. A consolidated approach would align regulatory practice with the realities of microbial ecology, supply chain complexity, and consumer demand for safe and wholesome foods.

In conclusion, the U.S. food protection system requires modernization and unification. Reform should focus on five core directives:

  1. Improving public health through risk-based regulation
  2. Eliminating overlap and duplication
  3. Streamlining enforcement and compliance
  4. Increasing accountability and modernizing governance
  5. Strengthening food protection as a component of national security

A unified federal food protection entity would provide a vision forward with four prime outcomes:

  1. Protect public health more effectively
  2. Reduce regulatory and economic burden
  3. Improve resilience against both natural and intentional threats
  4. Deliver a modern, science-based food protection system for the 21st century and beyond

“One system, one standard, one mission: Protecting America’s food supply from farm to fork.”

—Guiding principle for U.S. food safety efforts, FSIS

Click on the image to download the complete 45 page Whitepaper:

ICYMI: Click on the image to watch this recorded webinar with two of the Whitepaper Authors, Jason Bashura and  Ben Reading:

Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar

 

Ask The Expert

Food Safety 4.0: Defining the Next Era of Food Safety Performance

By Shahram Ajamian
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The food industry is operating in a world that looks fundamentally different from the one in which most food safety systems were designed. Digital technologies are now embedded across production, supply chains, logistics, and consumer interfaces. Data is generated continuously. Decisions are expected in real time. Transparency is no longer a differentiator, it is an expectation.

At the same time, the stakes have never been higher. Food safety events now unfold instantly, across borders, under intense public and regulatory scrutiny. A single failure can disrupt supply chains, damage brands, and erode trust at a global scale in ways that were unimaginable even a decade ago.

Yet despite this shift, many food safety programs still rely on operating models built for a slower, more linear world, models centered on periodic reviews, fragmented data, manual interpretation, and retrospective learning. These approaches were effective when systems were simpler and change was incremental. Today, they increasingly struggle to keep pace.

This growing disconnect between today’s operating reality and how food safety is managed signals the need for a fundamental evolution. That evolution is Food Safety 4.0.

Background: Industry 4.0 and Quality 4.0

Over the past decade, organizations across industries have undergone significant transformation driven by digitalization, connectivity, and advanced analytics, a shift commonly referred to as Industry 4.0. At its core, Industry 4.0 reflects the move from isolated systems and delayed visibility to connected, real-time awareness across operations.

The defining impact of Industry 4.0 is not automation alone, but speed,the ability to shorten the distance between what happens in operations and what leaders understand, decide, and act upon. Information latency, once accepted as unavoidable, is now viewed as a risk.

Building on this foundation, Quality 4.0 emerged as the evolution of quality management in the digital era. Quality 4.0 does not replace established quality principles; rather, it strengthens them by combining proven disciplines with modern technology, analytics, and a renewed emphasis on culture and leadership. The focus shifts from measuring outcomes after the fact to anticipating and preventing failure while enabling performance.

Together, Industry 4.0 and Quality 4.0 demonstrate a broader truth: modern systems demand modern operating models. Static, siloed approaches,regardless of how well designed,struggle to keep pace with today’s complexity, speed, and expectations. Food safety now faces that same inflection point!

What Is Food Safety 4.0 , and Why This New Term Matters

Food Safety 4.0 is the intentional application of Industry 4.0 and Quality 4.0 thinking to the unique responsibilities of food safety, protecting public health, meeting regulatory obligations, and sustaining consumer trust in a highly connected world.

  1. Food Safety 4.0 is a system-level approach that treats food safety as a continuous, enterprise-wide capability rather than a periodic program.
  2. It emphasizes predictive use of data and analytics to identify emerging risks before they result in loss of control.
  3. It relies on connected intelligence that integrates signals across processes, sanitation, supplier performance, deviations, complaints, and distribution.
  4. It enables adaptive control strategies that respond to changing conditions instead of relying solely on static rules.
  5. It reinforces culture, leadership accountability, and decision clarity to ensure insights translate into timely action.
  6. It moves beyond compliance as the endpoint and positions trust, resilience, and prevention as the ultimate outcomes.

More importantly, Food Safety 4.0 represents a new operating philosophy, not simply a new set of tools. I introduce this term intentionally and for the first time, recognizing that language shapes action. What an organization names, it prioritizes; what it prioritizes, it invests in; and what it invests in, it ultimately leads.

Historically, food safety has been framed primarily as a compliance requirement, a regulatory obligation, or a subset of quality systems. While these perspectives remain important, they are no longer sufficient on their own in a world defined by speed, complexity, and visibility.

Food Safety 4.0 reframes food safety as a system-level capability that operates continuously rather than periodically. It emphasizes prediction over reaction and performance over documentation. Most importantly, it positions food safety as a strategic driver of trust, resilience, and long-term value.

Naming this transformation Food Safety 4.0 provides clarity and momentum. It creates a shared language that aligns leaders, functions, and investments around a common direction,just as Industry 4.0 and Quality 4.0 have done in other domains. 

What Food Safety 4.0 Looks Like in Practice

At its core, Food Safety 4.0 represents the shift from programmatic compliance to predictive, system-level prevention. This shift is characterized by several fundamental changes.

Food safety data, process controls, sanitation results, supplier performance, deviations, complaints, and distribution signals,can no longer exist in isolation. Food Safety 4.0 connects these signals into a coherent, actionable view that supports faster and more confident decision making.

Instead of relying primarily on lagging indicators, Food Safety 4.0 emphasizes leading insight. Early signals, trends, and patterns become visible before failures occur, enabling intervention while outcomes are still controllable.

Controls themselves must evolve. In a dynamic operating environment, food safety systems must adapt to changing inputs, conditions, and risks rather than remain static and retrospective.

Equally important, Food Safety 4.0 reinforces culture as a foundational control. Technology does not replace human responsibility. It strengthens ownership, clarity, and speak-up behaviors so that people act on insight rather than simply record it.

Finally, Food Safety 4.0 moves beyond compliance as the finish line. Regulatory expectations remain essential, but they are the baseline. The ultimate objective is sustained trust, earned through consistent, transparent, preventive performance. 

Why Food Safety 4.0 Is Needed Now

Three forces make this moment decisive.

First, digital capability has outpaced food safety operating models. The tools already exist, but food safety has lacked a cohesive, future-focused framework to use them effectively.

Second, system complexity has exceeded human-only oversight. The volume and velocity of information generated across modern food systems can no longer be managed through manual interpretation alone.

Third, trust has become fragile and highly visible. In a connected world, food safety failures are not isolated events,they are brand-defining moments.

Food Safety 4.0 provides a way to meet these realities proactively rather than reactively.

A Leadership Imperative

Food Safety 4.0 is not owned by technology teams, nor by quality alone. It is a leadership responsibility. Defining the next era of food safety performance requires vision to modernize without abandoning foundational principles, discipline to integrate people, process, and technology, and courage to move beyond legacy ways of working.

Final Thought

Every major transformation requires language that makes change visible and actionable. Industry 4.0 did this for manufacturing. Quality 4.0 did it for organizational excellence. Food Safety 4.0 now defines the next era of food safety performance,one built for a digital, connected, high-expectation world.

References

  • Kagermann, H., Wahlster, W., & Helbig, J. (2013). Recommendations for Implementing the Strategic Initiative INDUSTRIE 4.0. acatech , National Academy of Science and Engineering.
  • Schwab, K. (2016). The Fourth Industrial Revolution. World Economic Forum.
  • Hermann, M., Pentek, T., & Otto, B. (2016). Design Principles for Industrie 4.0 Scenarios. Proceedings of the 49th Hawaii International Conference on System Sciences.
  • ASQ (American Society for Quality). Quality 4.0: The Future of Quality. ASQ Quality Resources.
  • LNS Research. Quality 4.0 Impact and Strategy Handbook. LNS Research.
  • Boston Consulting Group (BCG). (2019). Quality 4.0 Takes More Than Technology.
  • World Economic Forum. (2017). Shaping the Future of Advanced Manufacturing and Production.