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:
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.
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.
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.
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.
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.
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.’”
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]
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.
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.
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.
[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.
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.
“It’s not what we know that worries me. It’s what we don’t know,” said Jorge Hernandez, VP of Quality Assurance at The Wendy’s Company. He spoke with Matt Regusci and Francine Shaw, co-hosts of the “Don’t Eat Poop” podcast during the 2023 Food Safety Consortium to discuss his career, and how to make a difference as a food safety professional.
Hernandez began his career as a local and then state food inspector in Illinois before moving to U.S. Foods and then Wendy’s. Looking back on his early career, he noted that the most important thing he learned as an inspector is that people want to do the right thing, and if you take the time to explain the problem and offer solutions, they are willing to learn and will become compliant with the rules.
English is not Hernandez’s first language, which has helped him with his communication. “As I was learning English, I learned that it’s not what you say, but how they receive it,” he said. “So I’m very sensitive to ‘Are they understanding what I’m saying and my words?’ If not, I stop and listen to them and their feedback to make sure my message got through. If you just walk away, you don’t know if they got it or not.”
The need to develop relationships that extend beyond the transactional was a key message, particularly when it comes to suppliers. “To me a supplier is a partnership. How can I make them better and how can they make us better?” said Hernandez. “If it’s all about 5 cents here or 10 cents there, that drives a suppler to go around you or start doing things [you don’t want]. I’m committed to working with them to make them better, faster, more efficient, whatever it needs to be.”
Regusci and Shaw asked Hernandez to share the biggest changes he’s seen in the industry since he started his career. Technological advances were No. 1. “Technology has taken us a lot farther and moved faster than I thought. Now we’re looking at the DNA of bacteria and we can identify it and follow an outbreak to levels we never thought possible,” said Hernandez. “But also, there are practices we thought were safe and now we’re discovering, not necessarily. Look at listeria. While technology has helped us see more, there are a lot of risks that our systems are not able to handle, and we need to address that.”
In terms of future risks to the food supply, the evolutionary nature of bacteria and changes in weather are what keep him up at night. “Bacteria have been evolving and they will evolve to the point that our sanitizers and processes will not be effective. Also, the weather is changing; things are warmer. And in the U.S., we are seeing more outbreaks from bacteria that were more common in warmer climates,” he said. “So we need to be smart enough to know our technology and our food safety systems, but also flexible enough to prepare for what is coming next.”
When asked what he wished—as a former inspector—that food inspectors and regulators understood about the industry, he shared that, “People who are from outside the industry don’t acknowledge as much as they could or should that everyone is trying to do the right thing. They just need to understand the why and how.”
At the close of each episode, Shaw asks, “What does trust mean to you?”
“Trust means everything,”, said Hernandez. “In order for me to develop a relationship with a supplier, I need to trust them and they need to trust me. When I hire a new employee, I need to trust that they are going to do their job and they need to trust that I have their best interests at heart and that we as a company are going to take care of them and give them a career. Trust is essential to everything we do.”
Agriculture and food industries continue to be vulnerable to the complex problems of contamination with natural toxins. Mycotoxins, secondary metabolites produced by fungi, enter the food chain through infection of crops before or after harvest and are typically found in cereals, dried fruits, nuts and spices. Some have well established health impacts, both in humans and animals. A variety of testing solutions exist for mycotoxins, but growth in the use of methods based upon liquid chromatography with tandem mass spectrometry (LC-MS/MS) has enabled the determination of multiple mycotoxins. These methods are extremely sensitive and can be applied to the analysis of raw agricultural commodities, food ingredients and finished products.
Such LC-MS/MS techniques also serve as a powerful tool to investigate the presence of other natural toxins. They have been used for monitoring marine biotoxins[1], and to shed light on the distribution of toxins in terrestrial plants[2], highlighting them as a potentially serious food safety issue. Some terrestrial plants have evolved to produce secondary metabolites as defense mechanisms, which, while beneficial to the plant itself, cause harm to other organisms, including humans. In 2019, a humanitarian food aid product contaminated with tropane alkaloids (TAs) was distributed in Uganda, resulting in a foodborne outbreak which caused over 300 hospitalizations and five deaths[3].
Plant toxins can enter the food chain as constituents of plant products used in food processing or from the seeds and leaves of weeds mixed accidentally with the main food crop at harvest. Low levels of these toxins can be detected in cereals, herbal products, teas, salad crops and some animal products. One important class of plant toxins, pyrrolizidine alkaloids (PAs), are produced by a wide variety of plants commonly belonging to Asteraceae, Fabaceae and Boraginaceae families. Currently, there are more than 660 known PAs and metabolites. They are generally found in products such as honey, pollen, tea, herbal teas, food supplements, spices and aromatic herbs[4]. TAs are another class of plant toxins produced by plants, mostly within the Solanaceae family, and have been found in a range of agricultural cereal crops (e.g. linseed, soybean, millet, sunflower and buckwheat), tea, and herbal blends and infusions[5].
EU Legislation on Plant Toxins
The European Food Safety Authority (EFSA) has published the results of various risk assessments on those plant toxins considered to be the greatest risk to human health[6],[7], leading to the introduction of legislation on plant toxins in food by the European Commission[8]. Maximum levels have been set for PAs in herbs, spices, teas, herbal infusions and pollen products. These, which refer to the sum of 35 specified PAs (including their N-oxidized forms), vary between commodities. For example, the maximum level for PAs in most teas is 150 µg/kg, whereas the value for cumin is set at 400 µg/kg. Although there are more than 200 different TAs known, maximum levels have only been set for atropine and scopolamine (from 0.2 to 50 µg/kg, depending on the commodity). These regulations require that these plant toxins be monitored in specified foods by the Member State Food Safety Authorities and by food business operators, including those imported into the EU.
Access to data from retail surveys for PAs and TAs remains scarce when compared to that which is available for mycotoxins. However, in recent years, the number of food alerts reported on the Rapid Alert System for Food and Feed (RASFF) portal on the occurrence of PAs and TAs in different food products, exceeding maximum levels, has notably increased. The RASFF system was established to ensure the exchange of information between EU member countries to support swift reaction by food safety authorities in case of risks to public health resulting from issues with the food chain. Casado reported levels of PAs related to RASFF alerts with values ranging from 26 to 556,910 µg/kg[9], whereas the highest values of atropine and scopolamine were reported by Goncalves in tea and herbs (mean 173 and 147 µg/kg, respectively)[10]. In relation to consignments of cumin from Türkiye, a high rate of noncompliance with the relevant requirements provided for in EU legislation with respect to contamination by PAs was detected during official controls performed by the Member States[11]. The frequency of mandatory checks to be performed at border control has recently been increased to 30 %[12]. This has prompted greater awareness of the issue in other countries importing into the EU.
Techniques for Measuring Plant Toxins
Sampling plays a crucial part in precise determination of plant toxins levels in a certain lot, as contaminants within a lot may be heterogeneously distributed. It is also necessary to establish general method of analysis performance criteria to ensure that control laboratories use methods of analysis with comparable levels of performance. In December 2023, the European Commission published legislation establishing methods of sampling and analysis for the control of plant toxins levels in food[13].
Methods for PAs rely on extraction with acidified water, followed by solid-phase extraction (SPE) using a mixed-mode sorbent, which provides dual retention modes of reversed-phase and cation-exchange, followed by LC-MS/MS using alkaline or acidic chromatographic conditions[14]. The main analytical challenge is the presence of many isomers that are extremely difficult to resolve in the chromatographic dimension and exhibit the same MRM transitions. When attempting analysis in a single chromatographic run, one is left with a few pairs of coeluting isomers, which can be quantified as a sum. TAs are typically extracted with an acidified mixture of water and methanol/acetonitrile (including QuEChERS), followed by LC-MS/MS. Passing the extract through a simple ultrafiltration device or SPE cartridge can remove matrix co-extractives, enhancing method performance. To rationalize analyses in high-throughput laboratory environments, the scope of multi-mycotoxin methods can easily be extended to include the two regulated TAs, atropine and scopolamine[15].
While efforts have been made to address the food safety issue of plant toxins in Europe and reduce risk to the consumer, the number of food alerts seems to be on the rise. Fortunately, challenges with the determination of plant toxins in foods have largely been overcome, enabling testing to be carried out for checking regulatory compliance and monitoring occurrence, ensuring the safety of products for human consumption.
References:
[1] Panda D. et al. (2022). Recent advancements in LC-MS based analysis of biotoxins: Present and future challenges. Mass Spec Rev. 41:766-803.
[2] Urugo, M. et al. (2023). Naturally Occurring Plant Food Toxicants and the Role of Food Processing Methods in Their Detoxification. Int. J. Food Sci. 2023 Article ID 9947841, 16pp.
[3] Abia W. et al. (2021). Tropane alkaloid contamination of agricultural commodities and food products in relation to consumer health: Learnings from the 2019 Uganda food aid outbreak. Compr. Rev. Food Sci. Food Saf.20(1):501-525.
[4] Fuente-Ballesteros A. et al. (2024). Comprehensive overview of the analytical methods for determining
pyrrolizidine alkaloids and their derived oxides in foods. J. Food Compos. Anal.125:105758.
[5] De Nijs, M. et al. (2023). Emerging Issues on Tropane Alkaloid Contamination of Food in Europe. Toxins15(2):98.
[6] EFSA (2013). Scientific Opinion on tropane alkaloids in food and feed. EFSA Panel on Contaminants in the Food Chain. EFSA J. 11:3386.
[7] EFSA (2017). Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements. EFSA J.15:4908.
[8] European Commission (2023). Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. OJ L119:103–157.
[9] Casado, N. et al. (2022). The concerning food safety issue of pyrrolizidine alkaloids: An overview. Trends Food Sci. Technol.120:123-139
[10] Gonzalez-Gómez L. et al. (2022). Occurrence and Chemistry of Tropane Alkaloids in Foods, with a Focus on Sample Analysis Methods: A Review on Recent Trends and Technological Advances. Foods 11:407.
[12] European Commission (2024). Commission Implementing Regulation (EU) 2024/286 of 16 January 2024 amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries. OJ L 2024/286.
[13] European Commission (2023). Commission Implementing Regulation (EU) 2023/2783 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of plant toxins in food and repealing Regulation (EU) 2015/705. OJ L 2023/2783.
[14] Method Development and Validation for the Determination of Pyrrolizidine Alkaloids in a Range of Plant-Based Foods and Honey Using LC-MS/MS. Waters Application Note 720007624.
[15] Development of a Multi-Toxin UPLC-MS/MS Method for 50 Mycotoxins and Tropane Alkaloids in Cereal Commodities. Waters Application Note 720007476.
Food inspectors and public health officials generate a massive volume of inspection reports every year. Each of which needs to be reviewed and analyzed—a process that takes thousands of man hours. To Tom Sabo, Principal Solutions Architect at SAS, this is exactly the kind of problem that artificial intelligence/machine learning (AI/ML) and data analyticsare poised to address.
He worked with more than 10 years of data from the Chicago Health Department, using visual text analytics to review and analyze 92,000 free-form statements within inspection reports to extract actionable data. In November 2023, Sabo presented his findings at the American Public Health Association (APHA) annual conference.
We spoke with Sabo to learn more about his findings, how these tools can be utilized by public health agencies and the food industry and what’s next for AI/ML in food safety.
Before we jump to your work with the Chicago Department of Health, can you explain what visual text analytics is and how you used it in this project?
Sabo: SAS has a platform called Viya 4.0, which is a platform for data analytics, data management and visualization. Visual text analytics is a set of capabilities within this platform that perform text analysis, which is a way to process documents—or the information within documents—to better understand themes, extract key information and look for particular patterns in an automated manner.
In the context of food safety inspections, two of the things I looked for in the inspection reports were very serious issues, such as mentions of pest violations, and where those violations occurred. Then I tied them together by asking the platform to show me, for example, all the cases where there was some kind of pest issue in relation to where that pest issue was discovered, because that is now actionable information. Text analytics is what allows us to identify those patterns.
Visual text analytics can scan inspection reports and analyze terms related to serious food safety violations.
Can you tell me a little bit about the project you did with the Chicago Health Department?
Sabo: I didn’t work directly with them, but I did work with their data, which is publicly available. We pulled down their data from 2010 to 2021, which turned out to be 11,000 inspection reports done within the city of Chicago. Then we extracted out from the narratives freeform statements about specific issues and where they were identified.
This amounted to 92,000 freeform statements extracted from 11,000 reports. If someone were to manually go through those reports to identify the main issues mentioned, even if they spent only five minutes on a statement, it would amount to about 7,700 hours or four full-time employees working for one year.
We did talk to employees at public health agencies who said, if you are able to use these tools to help us better understand where our inspectors should spend their limited time, that would be very helpful to us. That’s why we started with serious issues. Our goal is to identify where the serious issues are occurring and answer questions about those incidents in the form of visual dashboards. And now we are adding generative AI, which helps us better communicate this information—what are the key issues and what can I do to prevent them—to folks who are not data scientists.
How does the platform report this information?
Sabo: We can generate a summary. For example, I would ask the large language model a question such as where should inspectors focus time and attention? And I would get a summary along the lines of “inspectors should focus their attention on areas where there is evidence of mice, rats, roaches and insects, including under prep tables, in produce areas, cabinets, all storage areas, basements and attics.”
Then, because the reports have geospatial information, I can drill down into the statements from the inspection reports that mention these areas of concern and stand up a map to see where issues occurred.
We could also do pretty fantastic things like look at an entire chain, such as all the 7-Elevens in the region, and assess across them where major issues were occurring. Inspection services could then get proactive and send that letters to these organizations stating, if you’re a convenience store, these are the areas that we recommend you do work in to prepare for your inspection: seal of the wall areas, ensure your door sweep is large enough to prevent rodents from coming into the establishment, etc.
The Viya platform was able to shift through inspection reports to identify patterns and map occurences. The addition of Gen AI allows users to ask questions and get answers to guide future inspections.
So you are reducing man hours in the review process and also providing more guidance to inspectors or establishments on where and what type of violations are occurring most frequently?
Sabo: Right. You can quantitatively determine that X out of 100 issues were related to storage areas, so when your inspectors come in, they can go back to the rear storage areas and make sure that clutter is removed and there is adequate lighting, for example. It helps inspectors focus in on the right places based on the evidence of where the issues actually occurred and were logged. And the algorithms we use can weight information based on what’s more recent. So maybe it would consider all the information it has been fed, but pay a lot more attention to the main issues in the last year.
What does the generative AI bring to the table that you don’t already have available with the text analysis?
Sabo: I come from a text analytics background. I’ve been doing this kind of work for years where I’ve been surfacing patterns and themes. What the generative AI (Gen AI) brings to the table, generally, is better communication of what’s going on at a high level. It allowed me to add a component to the dashboards that summarizes key questions, particularly around where should inspectors focus their time and attention.
For example, one of the questions I asked and could get an answer to from the Gen AI was, where are pest issues and where do they generally occur? I did not just go on my phone and hit ChatGPT. I fed the large language model with 1,500 statements—out of those 92,000 statements—that very specifically mentioned a pest issue in context of the location where it occurred. Once I fed my large language model with that data, I could then ask questions based on that data. I narrowed its domain so it could give me more focused answers that were more accurate. Based on this use case and many other use cases, I’ve seen the benefits of using text analytics as essentially a pre-filter for the large language models to focus in on key problems and answers.
Will the Gen AI tell you if it doesn’t have enough data to answer your question?
Sabo: It depends on how you work the large language model. In the case I’m working on, if I ask it something outside of its domain it will generally tell me, I don’t have enough information to answer that.
What is your next step in terms of developing or offering these tools?
Sabo: Now that we have done this work and proved it out with this set of data, the next step is to work with more agencies to help their overall public health strategies at the state and local level. We have worked with the FDA on using these capabilities to prevent chemicals from getting into the food supply. We have looked at drug and medical device safety and we’ve done work with the USDA FSIS looking at meat processing and using ML to help inspectors better prioritize their time based on the facilities that were most likely to have potential issues, based on past reports.
This platform is something that we could work with organizations on tomorrow. It took a matter of weeks to stand up the data that I presented at AHPA from the Chicago Health Department, so SAS is pretty well poised to work with any public health organization that’s interested in better understanding information from their inspection reports.
In the food processing and food service industry, glove wearing is meant to protect, not infect. That’s the theory, but not necessarily the reality.
Over 100 billion protective gloves—over 90% of the national supply—are imported into the U.S. each year from factories scattered throughout Asia. A good proportion of the gloves are destined for a substantial proportion of the 700,000 workers in meat and poultry processing and fresh produce sectors, as well as a proportion of the 14 million workers in the food service sector.
The FDA recently specifically classified gloves as Zone 1 Food Contact Surfaces, meaning in direct contact with ready to eat (RTE) ingredients or finished food products, and at the highest risk for product contamination.
The Food Safety Gap
However, there is a vital and contradictory gap in the oversight of quality assurance within FDA regulations. Here’s how the gap occurs. The FDA Compliance (21CFR177) for a glove to be called food-compliant involves a one-time single glove test conducted by overseas factories with an FDA-approved lab. The test is focused solely on chemical migration from the glove to food, and unless the manufacturer changes material ingredients, the test has no expiry date. “Food Compliant” gloves are not tested for bioburden, cleanliness or performance.
Complementary regulations also listed under FDA Title 21 Part 110 – Good Manufacturing Practice (GMP 21 CFR 110.10) require gloves to be “intact, clean, and sanitary” and “impermeable.” Upon arrival in the U.S. however, there is no requirement from the FDA for gloves to arrive “intact, clean, and sanitary” and “impermeable.” Gloves with FDA (21 CFR 177) compliance are imported “without the benefit of inspection.”
Why Does This Matter?
If you went down a food processing line and told every glove wearer that there was a 46% chance that the gloves they were wearing contained human fecal indicators, or potentially contained more than 250 unique and viable pathogens, what do you imagine the reaction would be? What would consumers think knowing the food on their dinner table might have been handled by potentially contaminated gloves?
The findings of a five-year study commissioned by Eagle Protect and undertaken by the B. Michaels Group revealed widespread risk of contamination in the disposable glove industry. The findings were presented at the 2019, 2021 and 2022 International Association for Food Protection (IAFP) annual meetings. Results found human fecal indicators on 46% of new and unused off-the-shelf gloves along with other foodborne pathogens and microbes including E. coli, Bacillus cereus, Bacillus anthracis, Listeria monocytogenes, Clostridiales difficile, Staphylococcus, Salmonella, Pseudomonas aeruginosa, Streptococcus pneumonia, and various fungi including Aspergillus.
Michaels, a leading microbiologist, ran the study, which involved independently testing 2,800 new and unused U.S. glove imports representing 26 different brands (approximately 25% of the ~100 SE Asian glove factories). Over 250 different viable microbial species were found on both the interior and exterior surfaces of the tested gloves.
Based on both observed conditions and events at SE Asian glove factories, as well as characteristics of microorganisms identified on or in disposable gloves, it was ascertained that microbes originate from contaminated water sources (rivers, drainage ditches and ponds). Once introduced into glove manufacturing facilities, contaminated rinse water circulates in and out of leaching or wash tanks, often not heated sufficiently, that are responsible for removing soluble chemical residues from glove surfaces.
In addition, gloves made of poor-quality materials can rip and tear, with particles finding their way into food products. Glove toxins can also contribute to a range of potential health issues including carcinogenicity, endocrine disruption, fertility impairment, metabolic disorders and skin diseases including dermatitis. For companies, there are issues with potential recalls, liability, worker compensation and consumer health.
How Can This Be?
In addition to dirty, polluted, contaminated water sources at factories, poor filtration, poor raw materials, unhygienic packing, poor hygiene practices by factory staff, lack of oversight and care by factory owners and, most important, lack of procurement standards on the part of U.S. corporate, business and institutional glove purchasers allow this to go on.
What Is the Solution?
There is little pressure on foreign glove manufacturers to self-regulate and improve their practices, unless businesses refuse to purchase from companies that cannot demonstrate acceptable standards. Therefore, the onus is on corporate and business purchasers of gloves. They need to be better educated about glove safety, including the risks of billions of potentially contaminated gloves on the hands of their workers in factories and plants, the potential risks to end consumers, and the value of adopting of clear standards for procurement that supersede the overwhelming criteria of “how cheap can we get them?”
Ask 1:Do manufacturers use Safe Ingredients? Are the raw materials tested to ensure consistency of manufacturing and to ensure the gloves are free of potentially toxic chemicals that might impact user and consumer health or contaminate food?
Ask 2:What is the Performance of the glove? Strength and durability tests and Acceptable Quality Level (AQL) further ensure consistent glove performance. AQL (maximum pinhole defects per 100 gloves) levels are required for medical and sterile gloves. There are no stated requirements by the FDA for Food Compliant Gloves. However, the standard should be at 2.5 (examination grade) or lower for food safety.
Ask 3:Are the gloves Clean? Bioburden on both the inside (skin contact) and outside (food and patient contact) can be tested to identify fungal and microbial contaminants that could pose a threat to the glove wearer, and the product handled.
Ask 4:Are the gloves Skin Tolerant? Poor quality gloves are often the cause of skin irritation. FDA Food Compliance does not ask for cleanliness, physical standards or toxicity tests. Gloves can be tested for a wide variety of chemicals and toxic exposure that could result in dermal or systemic toxicity, ensuring against skin irritation and occupational skin diseases of the wearer.
Ask 5:Is the factory making your gloves independently certified and does it use child or forced labor? Does your supplier or distributor have credentials such as being a registered B-Corp or accreditation by WRAP (Worldwide Responsible Accredited Production) organization, SEDEX (Supplier Ethical Data Exchange) or similar independent labor and quality verifications?
Ask 6: Is the product traceable? Does your glove box come with a QR code in which manufacturing activity is captured, secured and shared across the supply chain?
Consortium of Agreement to be Better Informed
The sight of blue gloves on a production line is universal. So too is the assumption that these gloves are safe by being “intact, clean, and sanitary.” Yet, we have learned that this is not always true. The only realistic action that can improve glove safety is for corporations to adopt standards, for glove wearers to demand quality gloves and for consumers to start asking “What’s in your gloves?”
Although regulators can set the tone that encourages industry to do the right thing, ensuring glove safety really does come down to suppliers and buyers uniting in a full-throated demand that there be a reduction in the risk of glove contamination in the U.S.
There needs to be a consortium of agreement from purchasers of protective gloves to shift from the lowest common cost denominator (cost) to a higher standard. The top 15 food producing companies in the U.S. have a combined market capitalization of $1.4 trillion so there is room to take some extra safety steps to implement a Supplier Code of Conduct using a system to conduct assessments and lab tests and to monitor outcomes.
Better and more informed decisions can be made by procurement departments. Food processing and food service companies all have safety and sustainability criteria; glove safety should be among the standards to adhere to.
We should be able to feel more at ease knowing that the gloves our food processing and service personnel put on are of the highest standards. This should be a paramount concern, not just to experts, but also the public who remain mostly unaware of the risks and dangers in glove manufacturing. Therefore, it is incumbent on all the industries involved in the making, selling and purchasing of gloves to adopt and advocate for a robust system for the manufacturing, tracking and quality assurance of gloves.
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