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Food Defense: Yesterday, Today and Tomorrow. 2021 FSC Episode 8

By Food Safety Tech Staff
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In this archived recording, experts in food defense and security address a range of important issues in this area, including risk-based approaches to food defense, threat intelligence, cyber vulnerabilities and critical infrastructure protection.

The session, Food Defense: Yesterday, Today and Tomorrow, discusses pre-FSMA IA Rule voluntary food defense programs, compliance timelines, and regulatory compliance vs. enterprise risk based approaches to food defense. Presenters will address the status of Food Defense plan quick checks and share insights on Food Defense Plan reanalysis. Participants gain insights on threat intelligence sources and food defense-based research updates. Other topics to be covered include a brief overview of recently released insider risk mitigation reference material, cyber/IT “vulnerabilities”, critical infrastructure protection and how an all-hazards mindset to “all of the above” can help to contribute to a Food Protection Culture.

The following is the line up of speakers for this episode,

  • Jason Bashura, PepsiCo (moderator)
  • Food Defense Yesterday with Raquel Maymir, General Mills
  • FBI HQ Perspectives of Food Defense with Helen S. Lawrence and Scott Mahloch, FBI
  • Food Defense Tomorrow with Frank Pisciotta, ASIS Food Defense & Ag Security Community and Cathy Baillie, Mars, Inc.
  • Risk-based Food Defense with Jessica Cox, Department of Homeland Security, Chemical Security Analysis Center
  • Food Defense & Supply Chain Perspectives: Regional Resilience Action Plan with Jose Dossantos, Department of Homeland Security/CISA

Watch On Demand video:  https://attendee.gotowebinar.com/recording/2149120139973957136


Biros' Blog

Food Protection: Prepare for the Unexpected

By Rick Biros
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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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Sayed M Naim Khalid
FST Soapbox

Celebrating World Food Safety Day Every Day

By Sayed M Naim Khalid
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Sayed M Naim Khalid

World Food Safety Day, organized by the World Health Organization in June each year, is a crucial reminder of the importance of safe food practices and the need to reduce foodborne risks. While awareness campaigns play an essential role in highlighting the significance of food safety, these efforts must be supplemented with concrete actions by businesses, organizations, and government institutions. To create a lasting impact, it is imperative to establish clear Key Performance Indicators (KPIs), allocate appropriate budgets, and set realistic timelines.

The Current Approach: Awareness and Advocacy

Campaigns and conferences serve as platforms for knowledge sharing, raising awareness, and fostering collaborations among stakeholders. They bring together experts, policymakers, and industry leaders to discuss challenges and share best practices. These events can inspire action and provide valuable insights into the latest developments in food safety.

However, the challenge lies in translating discussions into tangible actions. Without a structured approach, the momentum generated during these events can wane, leaving the critical issues of food safety unaddressed. Therefore, while advocacy is a vital first step, it is not sufficient on its own.

The Need for Clear KPIs

To move from dialogue to action, businesses and organizations must establish clear KPIs. These metrics will provide measurable goals to ensure food safety standards are met and maintained. KPIs should cover various aspects, including:

  1. Compliance Rates: Tracking the adherence to local and international food safety regulations.
  2. Incident Reduction: Monitoring the number and severity of foodborne illness outbreaks.
  3. Reduction in the number of recalls: Reduced recalls means improved processes and reduced food waste and savings for businesses.
  4. Training and Education: Measuring the effectiveness of food safety training programs for employees.
  5. Consumer Feedback: Collecting and analyzing consumer complaints and feedback related to food safety.
  6. Supply Chain Audits: Regularly auditing suppliers to ensure they meet food safety standards.

By setting these KPIs, organizations can track progress, identify areas for improvement, and hold themselves accountable.

Budget Allocation

Implementing effective food safety measures requires financial investment. Governments and businesses must allocate sufficient budgets to:

  1. Infrastructure Improvement: Upgrading facilities to meet food safety standards.
  2. Technology Integration: Investing in technologies such as traceability systems, automated monitoring, and testing equipment.
  3. Research and Development: Supporting research into new methods and technologies for improving food safety.
  4. Training Programs: Developing and delivering comprehensive training programs for employees at all levels.

A well-defined budget ensures that the necessary resources are available to implement and sustain food safety initiatives.

Realistic Timelines

Setting realistic timelines is essential for the successful implementation of food safety measures. Timelines should be based on the complexity of the tasks and the resources available. A phased approach can be effective, starting with high-priority areas and gradually expanding to cover all aspects of food safety.

For example, an organization might set a timeline to achieve the following:

  1. Short-term (6 months): Conduct initial audits, identify critical gaps, and begin staff training programs.
  2. Medium-term (1-2 years): Upgrade facilities, implement new technologies, and establish a robust monitoring system.
  3. Long-term (3-5 years): Achieve full compliance with all food safety regulations, continuously improve processes, and maintain a culture of food safety.

Collaboration and Accountability

Effective food safety requires collaboration among all stakeholders, including government agencies, businesses, non-governmental organizations, and consumers. Each party must understand its role and responsibilities. Governments should enforce regulations and provide guidance, businesses must implement and maintain food safety practices, and consumers should be informed and vigilant.

Accountability mechanisms, such as regular audits, public reporting of food safety performance, and penalties for non-compliance, are crucial for ensuring that all stakeholders adhere to their commitments.


World Food Safety Day is a valuable starting point, but it is not enough. To make a meaningful impact, businesses, organizations, and government institutions must set clear KPIs, allocate appropriate budgets, and establish realistic timelines. By doing so, they can ensure that food safety initiatives move beyond awareness and advocacy to create real, lasting change. Only through concerted and sustained efforts can we achieve the goal of safe food for all.


Francine Shaw
Food Safety Culture Club

Enhancing Food Safety Culture in the Food Service Industry: A Call to Action           

By Francine L. Shaw
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Francine Shaw

In the ever-evolving realm of the food service industry, the importance of food safety goes beyond mere regulatory compliance. It embodies a moral duty that directly affects public health, regulatory alignment, and brand reputation. Startlingly, recent data exposes a stark reality: only 49% of businesses have a structured food safety culture plan, including regular staff training, clear communication of protocols, and a system for documenting and managing safety concerns. This statistic is a wake-up call, underscoring the pressing need for heightened awareness and action within the food industry.

Food businesses need to do more than just file papers outlining the rules in a dusty old file cabinet. They need to implement and prioritize a food safety culture that permeates employees’ values, attitudes, beliefs, and actions. Their teams need to eat, breathe, and live food safety.

This cultural transformation requires consistent training, leaders who personify proper behaviors, empowered employees, a reliance on tech tools, more sustainable solutions, and teams that uphold stringent food safety standards. The benefits of such a culture are not just regulatory compliance but also enhanced brand reputation, increased customer trust, and improved public health.

Food businesses can accomplish this goal if they:

Train employees. Educating employees about food safety protocols is a crucial step in cultivating a strong food safety culture. This goes beyond just teaching employees what to do, it empowers them to actively safeguard food safety, benefiting both consumers and the establishment’s reputation. Misunderstandings due to lack of training can be damaging to public health, the organization’s reputation, and consumer trust.

Explain the rationale behind the rules. When employees understand the reasons behind the rules, they’re more likely to comply. Stating the ‘what’ of safety protocols without explaining the ‘why’ can lead to significant gaps in knowledge and motivation. When employees don’t consistently follow food safety rules, there can be potentially severe consequences for the organization and its customers. Understanding the reasoning behind each protocol empowers employees by helping them understand the importance of maintaining a safe environment. This knowledge fosters a sense of responsibility, encouraging them to prioritize food safety as an integral part of their daily routines. When employees comprehend the reasons behind safety measures, they can better identify risks. This proactive approach improves overall safety and promotes a culture of progressive improvement and attentiveness.

Incorporate tech solutions. Technology is a game-changer when it comes to food safety. Integrating AI, machine learning, IoT, and other advanced technologies is pivotal in advancing food safety practices. These technologies can automate data collection, analysis, and decision-making, enhancing transparency, accuracy, and data-driven decision-making. However, it’s important to note that these technologies are designed to supplement human efforts, not replace them entirely. Human judgment and expertise remain integral to the food safety process. Many food businesses have transitioned from manual processes to tech solutions. If yours hasn’t yet, it’s time to do so. Today’s tech tools are affordable, accessible, and intuitive for brands of all sizes and budgets.

Use the right sanitizers and disinfectants. One notable solution making waves in food safety is Hypochlorous acid (HOCL), lauded by the EPA for its potent sanitizing and disinfecting properties. HOCL is a non-toxic, non-irritant, and environmentally friendly sanitizer and disinfectant that’s 99.9% effective against many pathogens, including bacteria, viruses, and fungi. HOCL is 80-100x more effective than bleach, yet sustainable, chemical-free, and safe for humans and the environment. HOCL solutions are biodegradable and sustainable, aligning with organizations’ green initiatives. This solution, which doesn’t require rinsing can enhance shelf life, reduce water usage, and reduce labor expenses.

Lead by example. Effective leadership is essential to creating a robust food safety culture. Leaders must exhibit an unwavering commitment to food safety practices, instilling a culture of accountability and excellence within their teams. When leaders champion food safety, employees will follow suit. That means businesses can ensure a safer environment for their employees and customers, safeguarding their reputation.

Take a holistic approach. The importance of building and nurturing a food safety culture cannot be overstated. It demands a holistic approach, encompassing continuous training, transparent protocols, clear communication, seamless technology integration, steadfast leadership commitment, and a culture of perpetual enhancement.

By developing an atmosphere that places utmost value on food safety at every level, from management to frontline employees, businesses can shield themselves against potential food safety crises and safeguard their guests and reputations. This reduces the risk of legal, financial, and reputational repercussions. Additionally, it enhances brand reputation, fosters customer loyalty, and attracts new business. The food service industry must create and prioritize a food safety culture with unyielding dedication to mitigate risks and maximize successes and resilience.



David Hatch
FST Soapbox

Managing Food Safety Testing and Sanitation Data Should Be Easier

By David Hatch
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David Hatch

On three recent occasions, I have talked with food safety leadership at mid- to large-sized processors about their food safety testing and sanitation programs. While these organizations each face some unique challenges, there was a common theme that was clear among them all: The creation of meaningful and timely reporting that is communicated effectively is typically just too cumbersome and manual today.

Other industries have digitally transformed the management of testing, diagnostic, and sanitation workflows. Take, for example, the healthcare industry, where the electronic health record (EHR) has become the standard means of system-wide communication of patient health and risk information. All testing and diagnostic data related to a patient is added to their EHR, making it far simpler for medical professionals to access and use in their assessment and determination of appropriate treatment programs and medications. In addition, the EHR makes it easier for health providers and payor organizations to access aggregate data to assess outcomes, risks, and other measures relevant to the organizations and the industry.

The banking industry, which years ago established online electronic banking as the standard means of transacting business, provides another digital transformation example. Each personal or business account holder can be seen as a source of transactions (analogous to a series of diagnostic results), where there is an expected outcome. The old way of banking, via manual, paper-based systems, had many limitations, including the risk of human error.

Resistance to change abounded in each of these examples, but the benefits of accelerating access to information, eliminating human error, and streamlining the ability to collect, assemble, and deliver impactful analytics, far outweighed the hesitancy to move forward with new digitally supported methods.

In the food and beverage manufacturing and processing industry, resistance has remained very strong within Food Safety & Quality functions. This resistance has largely been the result of food safety regulation being viewed as a “compliance” necessity, and it therefore does not receive the same attention as a business innovation that yields a business growth outcome.

New thinking on this conundrum is starting to generate a different perspective on the matter, however. Early adopters of digital food safety management platforms have found several business benefits beyond streamlined compliance outcomes. At the 2023 International Association for Food Protection (IAFP), a panel of food safety leaders from three different organizations discussed their experiences in adopting digital software for managing their testing programs. Excerpts from this event can be found in this video.

The main discussion centered on how each organization established a business justification for adoption of digital technology to manage their testing programs. Here are three effective justifications that I have heard from leadership, which also featured in the discussion at IAFP:

  1. Time-to-Information: Digitally connecting testing workflows with the lab and triggering instant alerts as nonconforming results are detected is a major benefit. This can transform a team’s approach from reactive to being truly proactive and “preventative.” Catching issues before they blossom yields a huge business benefit, including the ability to launch and complete a Corrective Action without disrupting production.
  2. Operational Up-time Gains: Many organizations see an unplanned clean-in-place (CIP) process or tear-down as “a cost of doing business.” It does not have to be. When testing data reveals a trend that can be detected before it results in a major cleaning and operational delay, the financial benefits are profound.
  3. Team Efficiency and Fulfillment: Food safety technicians and leaders alike focus too much time on manually entering diagnostic result data and manipulating spreadsheets for reporting. Digital automation shifts the emphasis from data entry and preparation to analyzing and solving issues. This shift results in higher job satisfaction, less turnover, and lower costs in hiring and retraining.

If you are challenged with building a business justification for adoption of digital technology in your organization, perhaps the thinking in this article will provide a starting point.


Sayed M Naim Khalid
FST Soapbox

Food Safety: The Responsibilities of Government vs. The Private Sector

By Sayed M Naim Khalid
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Sayed M Naim Khalid

The role of government oversight versus private efforts in ensuring food safety is a comparatively new topic. Recent cases, including the hefty fines against Family Dollar for major violations in relation to sanitary conditions, highlight the importance of strong safeguards. But a key question lingers: Would a shift from government inspections to private audits truly benefit both businesses and consumers?

Government food safety inspections have traditionally operated on a risk-based model, aiming to identify and mitigate potential hazards in food production facilities. However, recent incidents such as the Family Dollar case raise concerns about the adequacy of government oversight. Did the absence of high-risk products at Family Dollar prompt less frequent inspections, leaving the facility unchecked for sanitation and safety standards? And what about past outbreaks like the 2009 Salmonella outbreak linked to the Peanut Corporation of America’s products or the subsequent recalls of Wright County/Hillandale Farms Eggs in 2010 and Cargill Ground Turkey in 2011? Weren’t these crises preventable with proper oversight?

It is evident that failures in both business management and government oversight contribute to lapses in food safety. While businesses are responsible for maintaining proper hygiene, temperature control, and product quality, government agencies play a crucial role in enforcement and inspection. The delay in detecting issues, whether due to resource constraints or bureaucratic inefficiencies, can have dire consequences for consumers and tarnish the reputation of businesses.

Consumers, too, play a pivotal role in the food safety equation. While cost often influences purchasing decisions, an increasing awareness of food safety issues has prompted many to prioritize product quality and trustworthiness. However, consumer vigilance alone cannot substitute for robust regulatory oversight and industry compliance.

The Value of Private Sector Audits

Private sector food safety audits offer a complementary approach to government inspections, providing businesses with standardized frameworks for assessment and improvement. Certifications from reputable third-party organizations such as the Global Food Safety Initiative (GFSI) can enhance consumer trust and facilitate market access. However, private audits should not serve as a replacement for government inspections. While they offer valuable insights, they lack the regulatory authority and enforcement capabilities of government agencies.

The crux of the issue lies in resource allocation and prioritization. Adequate funding for government food safety inspection departments at the federal, state, and local levels is essential to ensure timely and thorough oversight. Proactive inspections, coupled with stringent enforcement measures, can prevent crises before they escalate, ultimately saving businesses and consumers from costly repercussions.

Moreover, fostering a robust food safety culture requires collaboration and accountability across the entire supply chain. From farm to fork, stakeholders must adhere to best practices, comply with regulations, and uphold ethical standards. This includes not only businesses but also government agencies, industry associations, and consumers themselves.

The transition from government food safety inspections to private sector audits should not be viewed as a binary choice but as a symbiotic relationship. While private audits offer valuable insights and incentives for improvement, they cannot replace the regulatory authority and enforcement capabilities of government agencies. A balanced approach, characterized by proactive government oversight, industry compliance, and consumer awareness, is essential to safeguarding public health and ensuring the success of businesses in the food industry.

Paul Bradley
FST Soapbox

The Delicate Dance of Global Food Safety

By Paul Bradley
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Paul Bradley

A universal truth in bustling cities and rural villages alike is that people want to know the food they are eating is safe. Brands tasked with ensuring food safety walk a line between meeting regulatory requirements and balancing resource constraints. It’s a delicate dance in both developing and established economies.

At the federal level, we typically see programs designed to ensure food safety relegated to the back burner.  In the U.S., the FDA’s food program, a linchpin of food safety, has experienced its own challenges according to revelations from Stephen Ostroff. The two-term acting commissioner of the FDA has publicly revealed the internal struggles across various regulatory bodies both within the FDA and the U.S. regulatory system. Across the pond in the UK, efforts to modernize food safety and hygiene inspections have faced their own setbacks, including a lack of inspectors and poor cross-border coordination.

For nations at every stage of development, the road to food safety regulation is long and winding. Charting the way requires innovative solutions and collaborative effort on a global scale.

Challenges in Developing Countries

In developing countries, insufficient regulatory frameworks, a lack of enforcement, and the absence of modern technology and facilities for proper food handling and processing are major hurdles to ensuring broad food safety. We have seen time and again that efforts to improve food handling practices often result in short-lived change and challenges when scaling.

Beyond resource constraints, the prevalence of street vendors and local markets in the “informal sector,” which serve a significant portion of the population, typically lack oversight. A 2020 study published in the National Library of Medicine estimated that 2.5 billion people globally rely on street food for at least one meal daily, highlighting the importance of solving food safety concerns in this sector.

Food contamination also poses a serious threat. Microbiological pathogens including Salmonella, E. coli, Listeria, and chemical contaminants, can render food and water unsafe. According to a recent UN World Water Development Report, around 2 billion people globally don’t have access to clean and safe drinking water, and approximately 3.6 billion people 46% of the world’s population  lack adequate sanitation services.

The FDA’s Funding Dilemma

While food safety in the U.S. isn’t as dire as developing countries, we face a different set of concerns. The FDA’s historically underfunded food program has lagged due to staffing shortages, leadership issues and limited resources. A recent 10% increase in funding is a step in the right direction, but critics argue it’s still not enough. Many believe the agency prioritizes drug and medicine oversight and is biased towards appointing leaders with medical backgrounds rather than food industry knowledge.

Beyond the lack of funding and internal infrastructure, there is a broader push to restructure the FDA altogether. The 100+ year old agency created by the passage of the 1906 Pure Food and Drugs Act, is beginning to show its age. Today, with limited staff and resources, the FDA struggles to inspect foreign food shipments and physically examines less than 1% of imported products. With consumer palettes increasingly favoring global delicacies, this nominal inspection rate underscores the need for increased funding and a more innovative approach to FDA strategies.

UK’s Tightrope Walk on Food Safety

Similarly, in the UK, where the Food Standards Agency (FSA) governs food safety, budgetary constraints and other industry concerns are causing setbacks as it attempts to modernize inspections. The FSA has expressed concern that local authorities do not have the resources to deliver food controls, with new data revealing that they are a long way off from meeting the required frequencies of interventions at lower-risk establishments. As a result, some outlets in England, Wales, and Northern Ireland have not been checked for years. Additionally, UK’s exit from the European Union (Brexit), adds another layer of complexity, with potential disruptions to regulatory frameworks and the need for new trade agreements.

A Cautiously Optimistic Outlook on Global Food Safety

The global food safety landscape is at a crossroads and headed for extinction if changes do not take place within the next decade. Initiatives such as capacity-building programs, training workshops, and public-private partnerships empower individuals and organizations with the knowledge and skills necessary to implement effective food safety practices, while the global exchange of digital food safety data increasingly levels the information playing field for brands and regulatory bodies alike.

Achieving global food safety requires a multi-stakeholder approach that recognizes the unique challenges faced by different nations and leverages the strengths of various stakeholders. By focusing on prevention, capacity building, collaboration, and innovation, we can work towards a future where everyone has access to safe and nutritious food. This journey will require sustained commitment from governments, international organizations, the private sector, and individuals to ensure a healthy and sustainable future for all. For those of us in the business of helping to ensure food safety by creating a more transparent global supply network and making regulatory compliance easier to navigate, we are cautiously optimistic in the future and believe in the industry’s ability to rise above the challenge.

Don't Eat Poop logo
Food Safety Think Tank

The Importance of Proper Documentation in Food Inspections

By Food Safety Tech Staff
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Don't Eat Poop logo

The Lewiston, Maine, city council has voted to keep its local restaurant inspection program following a three-month saga that saw the ouster of the town’s code enforcement director and threats to eliminate its restaurant health inspector position following the temporary closure of a popular local restaurant due to a cockroach infestation.

The events in Lewiston have brought back not so pleasant memories for others who have faced retaliation and ostracism for doing their jobs. On the most recent episode of the “Don’t Eat Poop” Podcast, entitled “Good Job! You’re Fired,” co-host Francine Shaw recounted her own experience as she and Matt Regusci shared why this hits so close to home for many inspectors and auditors.

Earlier in her career, Shaw served as a health inspector in a small town, where she was called before the city council after closing a local restaurant for multiple violations. “The owner had friends on city council, and I got called in front of the council to defend myself,” said Shaw. “I went with all kinds of documentation including the inspection reports, images of the violations and documentation about what could happen based on the violations I found.”

As she described the violations and shared images of the cockroach infestation, mold in the ice trays and more, she saw the faces of the angry councilors, several of whom were regular patrons of the restaurant, change. “When I was finished, the council and the general public that came to defend this restaurant and attack me, there was nothing for them to say,” Shaw said.

While the council ultimately supported her decision, as they did in Lewiston (thanks to several restaurants who came out to support the inspector), situations like these are not unknown to inspectors and auditors. They also highlight the importance of proper documentation for all audits or inspections. “I’ve been threatened with lawsuits, but we do third-party auditing, so these are not publicly available documents,” said Regusci. “We investigate, and if the auditor was correct we say, ‘We are not settling, we are going to court and then all these auditing reports will become public.’”

Listen to the full episode here:



Jens Brockmeyer
Allergen Alley

HPLC-MS: Advancing Routine Food Allergen Testing

By Jens Brockmeyer, Eva-Maria Niehaus
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Jens Brockmeyer

In the U.S., allergens are the sixth leading cause of chronic illness with over 50 million people affected annually.[1] This is just one country among many that has seen the steady increase of the prevalence and severity of food allergies.[2]With increased media attention on this growing issue, food product labeling and allergen testing have never been under such scrutiny.

In food product labeling the stakes are high. Consumers need to know that the ingredient lists of the products they buy are accurate, and manufacturers need assurance that their foods are allergen-free, especially as current labeling guidelines lack clarity.

Food testing methods, which have hitherto been deficient in detecting and identifying unknown allergens and cross-contamination within the food manufacturing process, must be further developed to become quicker and more precise, cost effective, and user-friendly. New analytical tests can identify a broader range of potential allergens and offer food manufacturers a way to detect emerging allergens.

The Pressure for Improved Regulation

With the number of people suffering from food allergies in the U.S. doubling in each of the last two decades,[3] there is a high demand for food manufacturers to improve the allergen information they provide for consumers.

However, there is a lack of uniformity across different regions. While European Union law stipulates that allergens must be listed in bold on product ingredient lists, only 14 of the 200 foods that could potentially cause allergic reactions are prioritized[4] and, in the U.S., the FDA lists only nine key allergens.[5] Furthermore, while organizations such as Anaphylaxis UK agree that the most severe allergic reactions are caused by the consumption of a certain quantity of an allergen, there is no universal agreement on what such threshold levels should be.[6]

The allergens regulated by the FDA and EU.
Figure 1: The allergens regulated by the FDA and EU.

Single ingredients are not the only cause of allergic reactions: contamination and cross-contamination can occur at various stages of the food manufacturing process and put consumers at even greater risk.[7] Many manufacturers voluntarily use Precautionary Allergen Labeling (PAL) on their products to mitigate the risk of undeclared allergens, which may be used when there is a risk of allergen cross-contamination in the supply chain.[8] An example of PAL is ‘may contain milk’. This is not a legal requirement, however, and PAL protects the manufacturer more than the consumer as it is unlikely to be based on an assessment of the risk of cross-contamination for each of the 14 regulated allergens.[9]

Current Allergen Testing Options

Enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) are the two main analytical methods presently used to detect and quantitate allergens in routine food testing.[10]

Highly sensitive, the ELISA method allows for the quantitative and qualitative analysis of antigens, proteins, hormones, and antibodies in biological samples. It is most commonly used in the identification of foodborne microorganisms, such as Salmonella and L. monocytogenes, across a range of food products.[11]

Although ELISA can identify specific analytical targets, it cannot detect unknown allergens in contaminated food supplies. Moreover, the overall structure of proteins and their extractability is often altered during food processing, which can affect assay test results. Other factors, including poor comparability of results between test kits that use different antibodies, can also impact each test, and therefore make reproducibility between methods difficult.

A comparison of ELISA, PCR and MS.
Figure 2: A comparison of ELISA, PCR and MS.

PCR testing, which uses deoxyribonucleic acid (DNA) as a genetic marker, is popular because of its sensitivity and specificity, and also because sample preparation is standardized. A limitation of PCR testing is that, as an indirect indicator, it lacks sensitivity for foods that could contain high quantities of allergenic protein, but little to no DNA.[12]

Liquid chromatography-mass spectrometry (LC-MS) is not commonly used in current food testing. Unlike ELISA, LC-MS has multiplexing capabilities, allowing for the detection of multiple allergens in a single run. It can provide precise separation, identification, and quantification of the specific peptides rather than proteins in samples, which not only increases test accuracy, but also improves upon traditional testing methods by allowing for the differentiation of closely related allergens.

However, LC-MS, too, has limitations. The complex matrices of some biological samples can cause issues, and the various sample techniques needed for specific analytes mean that implementing a LC-MS workflow in routine testing laboratories is difficult. Professor Jens Brockmeyer and his team at the University of Stuttgart have been working on further advancing LC-MS to mitigate such drawbacks.

The Solution for Comprehensive Allergen Testing

A research team at the University of Stuttgart is investigating the influence of food processing on allergenic potential. The team is seeking to improve the methods used to screen for allergens primarily through the use of mass spectrometry (MS) and has developed a new workflow for allergen testing that delivers results quickly and efficiently.

There are three components to the novel method: sample preparation, analysis by high-performance liquid chromatography (HPLC) coupled to MS, and data analysis software. The approach can be used in the analysis of food products and allergens, making sample preparation easier and simplifying laboratory workflows.

The workflow for the allergen screening method.
Figure 3: The workflow for the allergen screening method.

Protein extraction, manual or automated enzymatic digestion, and the cleanup of peptides takes place to prepare the sample. Protein digestion takes three hours, a considerable time saving in comparison to the usual proteomic procedures.[13] HPLC-MS is used to generate data; the detection of precursor masses of the specific peptides resulting from the allergenic proteins of the given ingredient verifies the presence of each allergenic element.

The new multiplexed method removes the need to run multiple tests to identify each allergen individually; just one run is required for the detection of several allergens. This multiplexing capability and the analytical software’s ability to evaluate measurements retrospectively significantly accelerates experiment time.

Improved Visibility of Unknown Allergens

Current food testing methods, such as ELISA and PCR, are valued for their sensitivity but both lack multiplexing capabilities and produce results that are affected by food processing and thermal processing, respectively. HPLC-MS is an innovative method that offers multiplexed analysis of complex samples, producing standardized results in an accelerated timeframe suited to the high throughput needs of food testing laboratories.

With undisclosed allergens the cause of 42% of food product recalls in the U.S. in 2022,[14] the precision and speed of HPLC-MS offers exciting potential for the future of food allergen testing, paving the way for the feasible implementation of clearer and more stringent regulations.


[1] American College of Allergy, Asthma, & Immunology. Allergy Facts. Accessed at: https://acaai.org/allergies/allergies-101/facts-stats/. Last accessed: November 17, 2023.

[2] The Guardian. ‘It’s one of the great mysteries of our time’: why extreme food allergies are on the rise – and what we can do about them. Accessed at: https://www.theguardian.com/society/2023/jul/15/its-one-of-the-great-mysteries-of-our-time-why-extreme-food-allergies-are-on-the-rise-and-what-we-can-do-about-them. Last accessed: November 17, 2023.

[3] Food Allergy & Anaphylaxis Connection Team. Food allergy & anaphylaxis. Accessed at: https://www.foodallergyawareness.org/food-allergy-and-anaphylaxis/prevention/food-allergies-on-the-rise/#:~:text=The%20number%20of%20people%20with,identified%20food%20allergy%20(source). Last accessed: December 21, 2023.

[4] European Union. Annex 2 – allergen labelling. Accessed at: https://food.ec.europa.eu/system/files/2018-07/codex_ccfl_cl-2018-24_ann-02.pdf. Last accessed: November 15, 2023.

[5] U.S. Food and Drug Administration. Allergic to sesame? food labels now must list sesame as an allergen. 2023. Accessed at: https://www.fda.gov/consumers/consumer-updates/allergic-sesame-food-labels-now-must-list-sesame-allergen. Last accessed: November 8, 2023.

[6] Anaphylaxis UK. Allergen thresholds. Accessed at: https://www.anaphylaxis.org.uk/fact-sheet/allergen-thresholds/. Last accessed: November 16, 2023.

[7] Food Allergy Canada. Avoiding cross-contamination. Accessed at: https://www.foodallergycanada.ca/living-with-allergies/day-to-day-management/avoiding-cross-contamination/. Last accessed: November 16, 2023.

[8] Food StandardsAgency. Precautionary allergen labelling. Accessed at: https://www.food.gov.uk/business-guidance/precautionary-allergen-labelling. Last accessed: November 16, 2023.

[9] Food Standards Agency. Precautionary allergen labelling. Accessed at: https://www.food.gov.uk/business-guidance/precautionary-allergen-labelling. Last accessed: November 16, 2023.

[10] Allergen Bureau. Food allergen analysis. Accessed at: https://allergenbureau.net/food-allergens/food-allergen-analysis/. Last accessed: November 16, 2023.

[11] Law JW-F, Ab Mutalib N-S, Chan K-G, Lee L-H. Rapid methods for the detection of foodborne bacterial pathogens: Principles, applications, advantages and limitations. Frontiers in Microbiology. 2015; 5.

[12] Stoyke M, Becker R, Brockmeyer J, et al. German government official methods board points the way forward: Launch of a new working group for mass spectrometry for protein analysis to detect food fraud and food allergens. Journal of AOAC International. 2019;102(5):1280-1285.

[13] Switzar L, Giera M, Niessen WM. Protein digestion: An overview of the available techniques and recent developments. Journal of Proteome Research. 2013;12(3):1067-1077.

[14] U.S. PIRG Education Fund. Food for thought part 2: An analysis of food recalls for 2022. Accessed at: https://pirg.org/edfund/resources/food-for-thought-an-analysis-of-food-recalls-for-2022/. Last Accessed: December 21, 2023.

Rick Biros
Biros' Blog

In Defense of FSMA

By Rick Biros
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Rick Biros

The lead (pardon the pun) headline in Tuesday’s New York Times digital edition is “Lead-Tainted Applesauce Sailed Through Gaps in Food-Safety System: Hundreds of American children were poisoned last year. Records show how, time and again, the contamination went unnoticed.

The headline is misleading. The article says the cinnamon originated in Sri Lanka and was shipped to Ecuador, where it was ground into a powder. It was probably there, the FDA has said, that the cinnamon was likely contaminated with lead chromate, a powder that is sometimes illegally used to tint or bulk up spices.

The ground cinnamon was then sold, bagged, and sold again to a company called Austrofood, which blended it into applesauce and shipped pouches to the U.S. It was sold under the brand name WanaBana and various generic store labels.

The article states that Austrofood was last inspected five years ago, implying that this is the gap in the Food Safety System.

The authors did not look into the reasons why there are reductions in FDA inspections, which by the way, the FDA is ramping up again. FDA has seen huge budget cuts year after year reducing its ability to hire new inspectors. The Covid-19 pandemic reduced the number of inspectors and inspections dramatically.

The Food Safety Modernization Act (FSMA) is not perfect, but it is a huge step up from the past. The new powers and resulting responsibilities for FDA personnel, combined with the public’s expectation for the agency to do more (to protect the public) but with less resources must be part of the discussion as we dissect contamination events.