Tag Archives: Focus Article

Biros' Blog

Food Safety Fate

By Rick Biros
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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.

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

 

Listeria
Ask The Expert

Listeria – From the Ground Up. How to Identify, Find, and Eradicate the Bugger

By Bob Lijana
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Listeria

Over the coming weeks, we will share a series of six brief articles on Listeria. They are intended for food science professionals, especially food safety and quality assurance people. The information presented in these mini-articles will also be of interest to people in all functions. To that end, we have kept the language as non-technical as possible.

On roughly a biweekly basis, we will present mini-articles starting with what Listeria is, and the regulatory governance of Listeria in food from FDA and USDA. We will share background on where the organism comes from, how it can move around a food plant, and how to find it. We will share techniques on how to eradicate the pathogen. We will also share some insights on how to communicate learnings and successes, including with senior management. There will be references for further study.

Some of the information will already be known by those who have had to fight Listeria for many years, as is usually the case when this pathogen becomes your enemy. Yet that same information will be new and useful to those for whom the fight is new. These are people who are new to food manufacturing, or for whom a job in food safety and quality assurance is new.

Hence, pick and choose articles of most use to your situation as the series moves along. Yet do look at each one with a fresh pair of eyes–all of us could use a refresher in how best to manage the risk of Listeria in a plant, regardless of experience level. All plants and situations are different, so there is no “cookie-cutter” solution. If there were, we wouldn’t keep seeing recalls due to possible Listeria contamination. And we wouldn’t keep repeating history in that regard. We need to avoid complacence.

The ultimate objectives of this series are to provide suggestions of what can be done to manage food safety risks in a plant, and, at the same time, increase the company’s capability at providing safe food products and protecting public health.

See the Related Articles below to read the series.

To sign up for a free subscription to Food Safety Tech’s weekly Newsletter, click here

Beltway Beat

Agenda Posted & Registration Opens for the 2025 Food Safety Consortium Conference

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Food Safety Tech and the American Frozen Food Institute (AFFI) are excited to announce that registration for the 2025 Food Safety Consortium Conference held at the Crystal Gateway Marriott in Arlington, Virginia, from October 19-21 is now open.

The 2025 event will focus on the convergence of policy, science, and best practices. With the conference being held near Washington, D.C., this year’s program places a renewed emphasis on policy discussions, reflecting the growing need to address regulatory and legislative issues. The program will also prioritize the sharing of best practices, offering attendees the chance to learn from one another and engage in collaborative problem-solving on hot-button issues. The 2025 conference will continue the Consortium’s mission to:

  • Facilitate the exchange of scientific information and best practices among food safety professionals.
  • Address current challenges and advancements in food safety, technology, and compliance.
  • Promote collaboration between industry, academia, and regulatory bodies to enhance public health outcomes.
Donna Garren, Ph.D, Executive Vice President of Science & Policy, AFFI, at the 2024 Food Safety Consortium

Guiding the 2025 program was a newly formed committee:

  • Jason P. Bashura, MPH, RS, PepsiCo R&D, Global Food Safety & Quality Assurance, Sr. Manager, Global Food Defense, PepsiCo
  • Rick Biros, Content Director & Publisher, Food Safety Tech (Committee Co-Chairperson)
  • Erika Blickem, Director of Food Safety, J.R. Simplot Company, Inc.
  • Benjamin Chapman, Ph.D., Department Head, Professor, Food Safety Specialist, Department of Agricultural and Human Sciences, North Carolina State University, NC State Extension
  • Byron D. Chaves, PhD., Associate Professor & Food Safety Extension Specialist, Department of Food Science and Technology, University of Nebraska-Lincoln
  • Donna Garren, Ph.D., Executive Vice President, Science & Policy, American Frozen Food Institute (Committee Co-Chairperson)
  • Melody Ge, Sr. Director, Food Safety & Quality Operations, TreeHouse Foods, Inc.
  • Sanjay Gummalla, Ph.D., Senior Vice President, Scientific Affairs, American Frozen Food Institute
  • David Hatch, Vice President, Digital Solutions Marketing, Neogen
  • Jill Hoffman, Senior Director, Food Safety and Quality, B&G Foods, Inc.
  • Justyce Jedlicka, NA Commercial Applications – Food & Beverage Regulatory, Science & Lab Solutions,  BioMonitoring, MilliporeSigma
  • Barbara C. Kowalcyk, Ph.D., Associate Professor and Director of Institute for Food Safety and Nutrition Security, Milken Institute School of Public Health, George Washington University
  • Jeff Lucas, Technical Director, Mèrieux NutriSciences
  • Michael L Rybolt, Ph.D., Sr. Vice President, Food Safety & Quality Assurance, Tyson Foods

Donna Garren, Ph.D., Executive Vice President of Science & Policy at AFFI who co-chairs the program committee said “Last year’s attendees directed us to expand the program to support the education and learning of their entire food safety and quality assurance team. We responded by adding four new breakout sessions: Microbiological Track, Chemical Food Safety Testing Track, FSMA & Traceability Track and a Sanitation Track.” Garren added “I’m excited to announce our keynote speakers, Dr. Emilio Esteban and Ricky Dickson.”

Dr. Emilio Esteban, Chief Scientific Officer for Mérieux NutriSciences’ North America division, and Head of its Global Analytical Hub and former Undersecretary for Food Safety at USDA is the opening keynote speaker.

 

 

The closing keynote speaker is Ricky Dickson, Author and Former CEO of Blue Bell Creameries.

 

 

“The 2025 Consortium will build upon the success of previous events, which have featured high-level panel discussions, educational presentations, and pre-conference workshops.” said Rick Biros, Content Director and Founder of Food Safety Tech and co-chairperson of the program committee. Having the conference in the Washington DC area helps facilitate greater accessibility for FDA officials, other government representatives such as those from USDA and DHS, as well as industry associations.” Biros adds.

Women in Food Safety Networking Breakfast at the 2024 Food Safety Consortium

 

Table Top Booth at the 2024 Food Safety Consortium

“The committee’s collective expertise in food safety and leadership will be essential in shaping the conference program. The Consortium has always been a key platform for the convergence of policy, science, and best practices, and in 2025, we will ensure that policy discussions take center stage, especially given the proximity to Washington, D.C. AFFI’s work is always grounded in science, and our commitment to evidence-based solutions drives everything we do. This conference will continue to reflect that focus while fostering collaboration across all sectors of the food safety ecosystem.” said Garren.

The full program is available at FoodSafetyConsortium.org

Food Fraud Quick Bites

The Cascading Food Safety Risks from Tariffs on the Food Industry

By Benjamin Miller, Ph.D., MPH
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We’re now a month out from “Liberation Day,” the Trump administration’s launch to restructure global trade by increasing tariffs on imports into the US to levels not seen in over 100 years.  While “reciprocal tariffs” for most countries are currently on “pause” until July 9th, 10% across-the-board tariffs remain in place for many countries, with tariffs against Chinese products currently at or greater than 145%. These tariffs create interconnected challenges requiring systematic attention.

While it is inevitable that some buyers in tariffed countries will shift their purchases from U.S. suppliers to avoid the tariffs, it is just as expected that many U.S. food companies will shift their purchasing to domestic supply chains to save costs. And as those food companies move away from expensive imports, domestic growers and manufacturers may experience demand surges, creating a fundamental safety challenge where production pressures increase faster than the food safety infrastructure.

Increased Capacity Leads to Increase Risks

Processing facilities operating beyond designed capacity may compromise existing food safety management systems. Rapid workforce expansion typically outpaces adequate food safety training, increasing food safety handling risks, while quality assurance programs designed for standard production volumes become stretched if production volumes increase substantially. Companies expanding domestic production should conduct comprehensive risk assessments before increasing capacity, with particular attention to known or reasonably foreseeable hazards that may be compromised under accelerated production schedules.

Supply Chain, Traceability and Recording Keeping Concerns

The economics of high-value imported foods like avocados, mangoes, meat, and specialty cheeses will fundamentally change under the tariff structure. When legitimate import channels become prohibitively expensive, sophisticated black market operations emerge that specifically target food supply chains. These operations present unique food safety hazards, as products may be transported without temperature monitoring or verification; traceability documentation is often falsified, eliminating the ability to conduct recalls; and products may be “washed” through multiple intermediaries to obscure origin.

Food Fraud

Product substitution represents perhaps the most immediate economically motivated adulteration (EMA) risk in this environment. When high-value ingredients face substantial tariff increases, suppliers may substitute lower-value alternatives without disclosure. For example, we might see conventional produce falsely labeled as organic to command premium pricing that offsets tariff costs. Similarly, expensive oils like extra virgin olive oil might be diluted with cheaper oils while maintaining premium labeling and pricing. Food companies will need to enhance receiving processes specifically to identify potentially diverted products by implementing enhanced documentation verification, supplier approval processes, and potentially laboratory testing to verify product authenticity and safety.

Companies facing margin compression commonly target operational efficiency measures that inadvertently compromise food safety systems through extended production runs between sanitation cycles allowing biofilm formation and harborage point development, reduced preventive maintenance increasing equipment failure risks during production, and reformulation to extend shelf-life requiring additional validation.

Similarly, economic uncertainty may cause some international and domestic food companies to delay capital investments in food safety-related infrastructure, continuing to use equipment that may be past its useful lifespan or more difficult to clean and maintain, leading to increased microbiological or physical hazards during production.

While most food items from Mexico and Canada that meet the United States-Mexico-Canada Agreement rules of origin remain tariff-free, the Canadian supply chain realignment (due to long-term uncertainty around US policies) may represent a more than temporary adaptation—it may reflect a fundamental restructuring of North American food trade that will have persistent effects even if tariffs are eventually removed. New supplier relationships will need to be established and a holistic assessment of food safety programs should be conducted as part of new supply identification and onboarding processes. Canadian companies may approach these changes as permanent structural adjustments requiring comprehensive revisions to supplier verification programs rather than as temporary workarounds. In preparing for these challenges, companies should implement a structured approach that includes:

  • Conducting systematic vulnerability assessments of supply chains to identify specific points where tariff pressures create food safety risks.
  • Developing enhanced verification processes for the specific risks of rapidly onboarded new suppliers.
  • Revalidating critical control points under new operating conditions.
  • Implementing targeted testing programs for high-risk imported products potentially subject to black market diversion.

In these uncertain times, navigating the complex intersection of international trade policy and food safety requires specialized expertise that combines regulatory knowledge, technical assessment capabilities, and strategic planning.

Editors Note: this article was originally published March 12, 2025 and was updated May 5, 2025

Food Safety Consortium with AFFI 2024 logo
Beltway Beat

AFFI and Food Safety Tech announces 2025 Food Safety Consortium program committee, dates and Call For Abstracts

By Food Safety Tech Staff
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Food Safety Consortium with AFFI 2024 logo

Food Safety Tech and the American Frozen Food Institute (AFFI) are excited to announce that the 2025 Food Safety Consortium will be held at the Crystal Gateway Marriott in Arlington, Virginia, from October 19-21. The 2025 event will focus on the convergence of policy, science, and best practices. With the conference being held near Washington, D.C., this year will place a renewed emphasis on policy discussions, reflecting the growing need to address regulatory and legislative issues. The program will also prioritize the sharing of best practices, offering attendees the chance to learn from one another and engage in collaborative problem-solving on hot-button issues.

The 2025 conference will continue the Consortium’s mission to:

  • Facilitate the exchange of scientific information and best practices among food safety professionals.
  • Address current challenges and advancements in food safety, technology, and compliance.
  • Promote collaboration between industry, academia, and regulatory bodies to enhance public health outcomes.

“The 2025 Consortium will build upon the success of previous events, which have featured high-level panel discussions, educational presentations, and pre-conference workshops.” said Rick Biros, Content Director and Founder of Food Safety Tech.

Notably, past FDA keynote speakers have included Jim Jones, Mike Taylor, Steve Ostroff, Frank Yiannas, and Erik Mettler, supporting the FDA’s industry outreach objectives to the food and beverage industry. In 2024, James “Jim” Jones, Deputy Commissioner for Human Foods at the FDA, was the keynote speaker. His participation was particularly significant, as the Food Safety Consortium was one of the first conferences following the agency’s reorganization where Mr. Jones addressed the food industry. “In 2025, we plan to include FDA leadership in the program. Having the conference in the Washington DC area helps facilitate greater accessibility for FDA officials, other government representatives such as those from USDA and DHS, as well as industry associations.” Biros adds.

Guiding the 2025 program is a newly formed committee that includes:

  • Jason P. Bashura, MPH, RS, PepsiCo R&D, Global Food Safety & Quality Assurance, Sr. Manager, Global Food Defense, PepsiCo
  • Rick Biros, Content Director & Publisher, Food Safety Tech (Committee Co-Chairperson)
  • Erika Blickem, Director of Food Safety, J.R. Simplot Company, Inc.
  • Benjamin Chapman, Ph.D., Department Head, Professor, Food Safety Specialist, Department of Agricultural and Human Sciences, North Carolina State University, NC State Extension
  • Byron D. Chaves, PhD., Associate Professor & Food Safety Extension Specialist, Department of Food Science and Technology, University of Nebraska-Lincoln
  • Donna Garren, Ph.D., Executive Vice President, Science & Policy, American Frozen Food Institute (Committee Co-Chairperson)
  • Melody Ge, Sr. Director, Food Safety & Quality Operations, TreeHouse Foods, Inc.
  • Sanjay Gummalla, Ph.D., Senior Vice President, Scientific Affairs, American Frozen Food Institute
  • David Hatch, Vice President, Digital Solutions Marketing, Neogen
  • Jill Hoffman, Senior Director, Food Safety and Quality, B&G Foods, Inc.
  • Justyce Jedlicka, NA Commercial Applications – Food & Beverage Regulatory, Science & Lab Solutions,  BioMonitoring, MilliporeSigma
  • Barbara C. Kowalcyk, Ph.D., Associate Professor and Director of Institute for Food Safety and Nutrition Security, Milken Institute School of Public Health, George Washington University
  • Jeff Lucas, Technical Director, Mèrieux NutriSciences
  • Michael L Rybolt, Ph.D., Sr. Vice President, Food Safety & Quality Assurance, Tyson Foods

Donna Garren, Executive Vice President of Science & Policy at AFFI, who co-chairs the program committee, commented, “The committee’s collective expertise in food safety and leadership will be essential in shaping the conference program. The Consortium has always been a key platform for the convergence of policy, science, and best practices, and in 2025, we will ensure that policy discussions take center stage, especially given the proximity to Washington, D.C. AFFI’s work is always grounded in science, and our commitment to evidence-based solutions drives everything we do. This conference will continue to reflect that focus while fostering collaboration across all sectors of the food safety ecosystem.

Food Safety Tech and AFFI are requesting presentation and panel discussion abstracts for consideration to be presented during the Food Safety Consortium Conference, Oct. 19-21, 2025, Crystal Gateway Marriott, Arlington VA.

Submit Your Abstract    Abstract Submissions are due by March 17

Chinese fuel tankers being used to transport both fuel and food oil products, without any cleaning process between

By Food Safety Tech Staff
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On July 2, the Beijing News reported that the state-run oil and grain company, Sinograin was using the same tanker trucks to transport both fuel and food oil products, without any cleaning process between.  According to the website, ChinaMediaProject.org, the tankers were transporting soybean oils and syrups together with coal-to-oil (CTL) products, which use coal as a raw material to produce oil and petrochemical products through chemical processing. The scandal has implicated other major Chinese companies including Hopefull Grain and Oil Group, a private conglomerate as reported  in the Guardian.

In the Beijing News report, an undercover reporter interviewed a trucker who had driven a tanker of coal-derived fuel from Ningxia, a region in the west of China, to the east coast city of Qinhuangdao in Hebei, a journey of more than 800 miles (1,290km). The trucker told the journalist he was not allowed to return with an empty vehicle, and subsequently drove to a facility in another part of Hebei to load up with nearly 32 tons of soya bean oil, without cleaning the tanker. Several other tankers featured in the article made similar journeys without any washing or sanitizing of the tank in between.

The Beijing News is a state-run newspaper under Beijing municipal propaganda office that into the early 2010s was among the country’s more outspoken professional outlets. Stories like this have become a true rarity in the Xi Jinping era, as the leadership has emphasized “positive propaganda” and the need for media to abide by “correct public opinion guidance.”

There is no mandatory national standard at present for the transportation of edible oil in China. There is only a recommended Code for Bulk Transport of Edible Vegetable Oil, which mentions that special vehicles should be used for the transportation of edible vegetable oil in bulk. Because it is a recommended national standard, this means that it has limited binding force on manufacturers.

This week the office of the food safety commission under China’s State Council said it was investigating the claims and that “individuals found violating the law through improper use of tanker trucks will face severe punishment”.

It is not clear where the cooking oil in the fuel-contaminated tankers ultimately ended up. Follow-up reports tracking the truckers identified in the Beijing News article suggested that the tankers delivered oil to packaging facilities run by household brand names in China, intensifying concerns that people could be consuming toxic oil. The article also quoted an industry insider as saying that some of the oil may ultimately be packaged into small bottles for foreign sales.

Photo Credit: Rick Biros

Ready.gov
Biros' Blog

Food Protection: Prepare for the Unexpected

By Rick Biros
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Ready.gov

In a June 24 New York Times article, ‘It’s Happening Again’ the Supply Chain is Under Strain, the head of ocean freight for a logistics company said “I’m lovingly calling the (logistics) market now ‘Covid junior,’ because in a lot of ways we’re right back to where we were during the pandemic. It’s all happening again.”

The Covid supply chain disruptions hit the industry hard, forcing manufacturers to source new ingredient suppliers. Trying to quickly approve (or disapprove) new suppliers put a massive strain on food safety and quality assurance departments who were (are) tasked with doing more with less. Most of the industry really was not prepared for this magnitude of disruption. However, food and beverage industry will always face a myriad of threats to our FSQA organizations. How do we manage to reduce the risks of these threats from impacting our organizations? We evaluate, we assess, we PREPARE for the unexpected – through planning, workforce development and learning from the past. Pick your poison:supply chain disruptions, emerging and virulent pathogens, man-made and natural disasters, new regulations, bird flu, PFAS’, food fraud (think cinnamon tainted with lead and the cross-functional collaborations needed to protect the public’s health), just to name a few.

Food Safety Tech advisor and friend of mine, Jason Bashura, MPH, RS, Sr. Manager, Global Food Defense, PepsiCo has shared with me for years concepts related to the development of  a Food Protection mindset. Food and beverage manufacturers companies are naturally concerned about protecting the public’s health and well-being, their brands and their own company’s financial bottom line. The phrase  “Food Protection” requires a company-wide culture that incorporates the concepts of quality, food safety, food integrity ,food defense, EH&S, physical and cybersecurity concepts into the company’s approach to the envelope of “Food Protection.” Prior to FSMA, in 2007, the FDA released the Food Protection Plan which was founded on the themes of prevention, education & response  all of which are key underpinnings of not only FSMA today, but as embedded within the New Era of Smarter Food Safety, for tomorrow. Today, the FDA funds Food Protection Task Forces across the U.S., and the use of the phrase Food Protection is more ‘prevalent’ than you think: how many uses of this term do you hear regularly? How many other Food Protection ‘elements’ there are? Please add your thoughts in the comments section below.

In recognition of the theme for this year’s  World Food Safety day  – Prepare for the unexpected –  underlines the importance of being prepared for food safety incidents, no matter how mild or severe they can be. Food Protection is all about being prepared. Many firms recognize, celebrate and embrace World Food Safety Day as a month long celebration.

Jason can both talk the preparedness talk and walk the preparedness walk! Prior to his work at PepsiCo where his full-time job is predicated on protecting PepsiCo’s worldwide consumers, , he also has organized the Food Defense Consortium, an informal working group of FSQA, physical security, academia and other Food Defense professionals who share best practices, lessons learned and simply share information amongst the group. The Food Defense Consortium meets regularly via zoom and once a year in person at the Food Safety Consortium conference. Jason has a history of “being prepared” as a Volunteer with the Storm Engine Company #2 & the Storm Ambulance Corps in Derby CT, having served as a public health emergency response coordinator at the Naugatuck Valley Health District (CT), and an avid volunteer with the Valley Chapter of the America Red Cross (CT). He is currently serves as a community volunteer member – with environmental health experience – of the Board of Health for the Howard County Health Department (MD).

 

Frank Pisciotta, Chair, ASIS Food Defense Community and Jason Bashura, Facilitator, Food Defense Consortium presenting me with a Certificate of Appreciation for hosting the Food Defense Consortium at the Food Safety Consortium conference as well as publishing the Food Defense Resource Center on Food Safety Tech.

 

 

Another example of preparedness is Rick Rescorla who was the epitome of thinking WHAT IF on the day to day, about how to prepare, educate and respond to a variety of situations that might arise. As director for security at Morgan Stanley in New York City on September 11th  2001, he is credited with saving greater than 2,700 lives thanks to his relentless pursuits for countless hours of education and raising awareness of how to deal with adverse conditions in an evacuation environment.

I guess one should practice what you preach. I listen to Jason and am working to be better prepared for the unexpected. A few years ago, I was “volunteered” to be the Captain of the Chappaquiddick Island CERT (Community Emergency Response Team). We coordinate with the fire department in advance of storms like Nor’easters and have a plan in place for the power being out and no ferry service to get off the island.

As we close out World Food Safety month, we need to not only learn from the past to prevent future issues – so that “it” doesn’t happen again –  we need to embrace the opportunities that we face every day that help us to be better prepared, for tomorrow. As Colonel John “Hannibal” Smith from the original 1980’s “A-Team” tv show used to say “I love it when a plan comes together.”

Food Protection Resources:

  • For more information on how you can PREPARE your business for the unexpected, visit READY.gov
  • For more information on the Food Defense Consortium, visit the Food Defense Resource Center on this website or contact Jason.Bashura@PepsiCo.com
  • Rick Rescorla Citizen Honors Reward
  • Jason Bashura will be co-presenting at the Food Safety Consortium Conference with Jon Woody, Director, Food Defense, CAPT, USPHS, FDA and Debby Newslow, President, D.L. Newslow & Associates on the critical importance of developing and implementing a food defense plan to comply with the FSMA rule 21 CFR Part 121 (IA Rule)

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Collaboration Graphic

Proposed Collaborative for FSMA 204 Compliance Seeks Industry Support

By Food Safety Tech Staff
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On Tuesday, January 20, 2026, the food industry will need to be compliant with FDA’s FSMA 204: Requirements for Additional Traceability Records for Certain Foods (aka, Food Traceability Final Rule). Compliance with the final rule will require adoption of new technologies and streamlined communication and record-keeping throughout the supply chain. To help ensure compliance and success in meeting the intent of the rule, Leavitt Partners and Acheson Group are working with FDA to create a public-private governing body for food traceability, based on the medical industry’s Partnership for DSCSA Governance (PDG).

Eric Marshall, Leavitt Partners
Eric Marshall

Founded in 2019, the PDG is a collaborative of pharmacy industry members working together to help the industry implement the Drug Supply Chain Security Act (DSCSA) and develop a sustainable, effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S.

“DSCSA and FSMA do have significant differences. For example, there are unique requirements for bar codes, serialization and electronic interoperability in the medical industry,” said Eric Marshall, Principal at Leavitt Partners and Executive Director of PDG. “But at the core, they have a lot of similarities and they both have the same goal from the government’s viewpoint: modernizing industry’s data and recordkeeping practices to create supply chain traceability that helps industry and government together react faster and more effectively to risks in our food and drug supply chains.”

Last month, Erik Mettler of FDA joined Marshall and Laura Brown of Leavitt Partners and Ben Miller and Eric Edmunds of the Acheson Group for an informational webinar on the proposed project.

Eric Edmunds, Acheson Group
Eric Edmunds

The goal of the public-private partnership is to:

  • Help industry decide how to meet the core issues of FSMA 204, so stakeholders are not wasting money on different technologies that others are not using or accepting
  • Bring together divergent industry groups working on disparate plans for getting to compliance and bring this work together into one cohesive vision
  • Ensure all sectors of the industry have a voice in the process
  • Provide a decision-making mechanism for those key components of compliance that require a shared view throughout the industry
  • Develop a coordinated plan and timeline to get from today to the compliance date
  • Develop core requirements to which commercial solution/software providers can build
  • Hold collaborative interactions with FDA
  • Create a shared IP (i.e. industry lookup directory) needed to achieve compliance

The vision for the collaborative is to create “an independent, sector-neutral forum for the industry to come together to jointly define a shared vision for enhancement of traceability,” said Edmunds.

Recognizing that the deadline for compliance is fast approaching, Leavitt Partners and Acheson Group are currently seeking industry members to act as part of a working group to finalize the operating structure of the organization, which they envision as encompassing a general membership tier with elected officers and board members, and multiple committees. Their goal is to organize the working group and define key organizational aspects of the collaborative by end of June; secure 35 members, form the legal entity and hold Board elections by end of July; and by the end of 2024 begin awareness and education campaigns, committee work and blueprint development, and establish the 2025 budget.

Learn more about Proposed Collaborative for FSMA 204 at the Food Safety Consortium Conference, October 20-22 in Washington DC. Join us in this panel discussion which will provide an update on the status of the governing body, why there is a need for an overarching blueprint to drive food traceability processes and standards, the value in identifying a shared industry infrastructure for food traceability – and how you can become involved. Both Eric Edmunds and Eric Marshall are the presenters.

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Nicole Keresztes James

Five Tips to Prepare for Your Next Audit

By Nicole Keresztes James
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Nicole Keresztes James

For food manufacturers, passing a third-party food safety and quality audit supports both business growth and the ability to obtain new customers. Many retailers have made certification to a GFSI-benchmarked standard a minimum requirement of their suppliers. Working towards compliance with a third-party audit, let alone a GFSI-benchmarked certification, is a journey that requires significant preparation. Understanding the typical mistakes companies make on this journey, and taking action to avoid them can go a long way in properly preparing for and successfully passing the audit. Here are five essential tips to help businesses prepare for a food safety audit.

1. Start Early

Procrastination is on one of the most common causes of an audit failure. Starting the preparation process too late can cause significant challenges. The first step in preparing for an audit should be to set a timeline well in advance, identifying key checkpoints and milestones to ensure activities meet compliance.

If you have the option, choose an audit standard that fits with the facility and meets the end goal. Some questions to ask in your selection process include:

  • Is the certification to a GFSI-benchmarked standard required?
  • Is a completed third-party food safety and quality audit sufficient?
  • Is a customer-specific audit needed?

Once you’ve decided on the audit standard, select a third-party certification body or audit firm to deliver an audit to the standard’s requirements. Ensuring that the certification body or audit firm you choose is qualified to conduct the audit (e.g., accredited or approved by the standard) is crucial.

Next, secure a copy of the selected standard. With GFSI-aligned programs (including GFSI and non-GFSI benchmarked standards), standard expectations are available freely and directly from the certification program owners. In the case of proprietary third-party audit and customer standards, the chosen certification body or audit firm can assist with providing the necessary expectations.

2. Get Up to Speed

It is extremely important to thoroughly review and familiarize yourself with the standard or expectations manual, especially if the standard or manual is new to the facility. If the audit is a reassessment, ensure you have the most recent version of the standard or manual and thoroughly read it, as updates may have been made since the last audit.

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One mistake we sometimes see is failing to designate an internal core team for the audit. Doing so can help ensure the timeline is followed and critical tasks are assigned accordingly. If you are doing a reassessment, ensure that all internal organizational changes have been documented and that organization charts and rosters have been updated.

For reassessments, it’s also important to revisit any nonconformances from previous audits and the reports of any other assessments or internal audits completed. Doing so ahead of time can confirm that corrective actions have been fully implemented and preventive actions put in place, minimizing the recurrence of nonconformances.

3.Complete a Self-Assessment

Conduct an internal audit using the audit standard or expectations manual to identify compliance gaps. Address any deficiencies through corrective actions, focusing on areas such as sanitation and cleanliness, facility condition, pest management programs and maintenance protocols. Looking at each of these areas, identify and address opportunities for improvement. Issues in these areas are very often cited as nonconformances during audits.

Before the audit, meet with your third-party service providers to ensure programs are up to date and that there is awareness of any issues. Even when programs, such as pest control, are outsourced to third-party organizations, the facility remains responsible for overseeing such programs.

4. Prepare Documentation and Ensure Implementation

Documentation is critical for audit success. Ensure a comprehensive review of your food safety systems (e.g., HACCP and FSMA PC) to ensure that they are current and valid. Review the efficiency of your process implementation and verify that the documentation and processes are aligned.

Training is a must-have for audit compliance; therefore, confirm that internal training has occurred and been documented. This includes training not just for the team escorting the auditor during the audit but for all employees, as during the visit employees in functions key to the audit’s scope may be called on by the auditor to answer questions. Remember, well-trained employees are confident in conducting and describing their processes and how they connect to food safety and quality. They must also follow the procedures as stated in the documented programs and policies.

5. Collaborate and Ask for Help

Failures occur when assumptions are made. Many audits are unsuccessful because facility management and employees assume they understand and have implemented the necessary requirements.

When in doubt, ask for help. As stated above, preparing for any audit is a significant undertaking. Expert resources can help with that preparation and assist with avoiding gaps and the rework that occurs when expectations are not clearly understood. Check with the certification body or audit firm that has scheduled the audit—many will offer separate consulting and training services to help with audit preparation.

It is important to note that one facility is just one point in the overall supply chain and that stakeholders include both suppliers and customers of the facility. These suppliers and customers can play a role in the success of an audit. Ensure that communication with all involved parties is part of the preparation.

Keep the Momentum Going

Once you complete an audit, celebrate and congratulate the team. At the same time, remember that the work doesn’t end once the audit is complete. Even after completing the corrective actions, you should start preparing for the next audit by keeping documents and records updated. Adequate food safety and quality assurance are only possible when activities connected to these concepts are carried out every day. Keeping compliance top-of-mind daily has the additional significant benefit of always being audit-ready.

As the adage says, “Fail to plan, plan to fail.” This certainly rings true with audit readiness. However, it is key to remember that an audit is merely a data point on the spectrum of a robust food safety and quality system that is constantly evolving and improving. This comprehensive system does not come about just because there is an audit to plan for. It is a product of daily work to ensure that procedures and policies are being followed and a cross-functional team that is striving to make a facility’s food safety culture stronger and ever more capable of preventing food safety and quality incidents.