Tag Archives: FSMA

FDA Logo
Beltway Beat

FDA Publishes New Guidance Document for Voluntary Qualified Importer Program

By Food Safety Tech Staff
No Comments
FDA Logo

FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.  Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.  This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP.  “Agency” and the pronouns “we” and “our” are used to refer to FDA.  The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

Español (Spanish)

It’s 5 o’clock somewhere! A Happy Hour conversation about food safety & quality

No Comments

Episode 1: A Conversation with Dr. David Acheson, President & CEO, TAG. In 2012, David was an early advisor to Rick in the launch of FoodSafetyTech.com and the Food Safety Consortium conference. Back then, many things were new and evolving including the proposed Food Safety Modernization Act (FSMA). Rick and David will look back at FSMA, how it has evolved and discuss the future FSQA risks and challenges.

Biros' Blog

It’s 5 o’clock somewhere!

By Rick Biros
No Comments

Join me in a happy hour conversation with David Acheson, President and CEO of TAG called “It’s 5 o’clock somewhere!” Podinar Broadcast: Thursday, August 22 at 5 o’clock EST.

In 2012, David Acheson of TAG was an early advisor in the launch of Food Safety Tech and the Food Safety Consortium conference. Back then, many things were new and evolving including the proposed Food Safety Modernization Act (FSMA). David and I will look back at FSMA, how it has evolved and discuss the future FSQA risks and challenges.

This is the premiere of a new podinar series. What’s a podinar? Simply, a podcast using a webinar platform. It’s a conversation. Unscripted. No slides. Just talk… over an adult beverage.

Join me and David in a casual but engaging conversation. Adult beverage is optional but encouraged!

Complimentary but advanced registration required. Click Here.

Traceability in food manufacturing, Honeywell
Beltway Beat

Produce Traceability: Uncovering the Gaps in Your Program

By Samantha Humphrey
No Comments
Traceability in food manufacturing, Honeywell

The produce industry handles an estimated six billion cases of produce in the U.S. each year. [i] Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods [ii] (Food Traceability Rule), the question is whether these existing traceability programs, systems, and procedures meet new FDA requirements.

A gap assessment can do just that—determine what requirements your existing programs already meet and identify where improvements are needed to comply with the final Food Traceability Rule by the January 2026 deadline.

Steps for Conducting a Gap Assessment

Not surprisingly, many produce companies already have elements of a traceability program that fulfill some of the Final Rule’s requirements. A gap assessment serves as the starting point for:

  • Understanding your regulatory obligations compared to your current compliance status.
  • Determining if existing programs, procedures, and systems are good as is, need improvement, or are missing and need to be developed.

Performing a gap assessment will help you compare what you have to what you need. The following steps will get you started:

  1. Find the most current copy of the standard you will compare against your programs. You will likely want to use the Code of Federal Regulation (CFR) Title 21, Chapter 1, Subchapter A, Part 1, Subpart S [iii], as it outlines specific expectations for general provisions, Traceability Plan, records of Critical Tracking Events (CTEs), and more.
  2. After you are familiar with the rule, review the most current version of your own program. A systematic review over time may make conducting a gap analysis more manageable. Start by identifying which of your products are on the Food Traceability List (FTL) [iv], what CTEs you perform, and which Key Data Elements (KDEs) you are already collecting. Have you overlooked a CTE? Have you forgotten a KDE? Refer to the questions below as you conduct this gap assessment. Document all missing elements.
  3. Compare your Traceability Plan to what is required by the new rule. Document the items you have identified as missing from your Traceability Plan.
  4. Develop and document your strategy to address each gap identified in steps 2 and 3 above. There may be some items that can be addressed immediately, while others may require additional time and support. You may need to create new logs, enlist the help of other departments, or acquire approval from your supervisors to make the necessary changes. Set realistic goals to implement the required updates by the compliance date.
  5. Train or retrain employees. Tell them why the changes are happening, acknowledge the importance of compliance with the new rule, and empower them to make the necessary changes.
  6. Notify management, customers, and suppliers of changes to your program to ensure everyone involved is on the same page.

Turning Gaps into Opportunities: Key Questions to Ask

Asking the right questions is key to ensure your gap assessment identifies required missing elements in your programs compared to the rule. The following questions can help guide your food traceability gap assessment:

  • Do you manufacture, pack, process, or hold any of the foods found on the FTL? The FDA developed the FTL considering a few specific food safety factors, including frequency of outbreaks, occurrences of illness, severity of illness, likelihood of contamination, potential for pathogen growth, process contamination, consumption rate, and cost of illness. Comparing your products to the FTL may indicate the likelihood of your produce being implicated in a recall or outbreak event and will underscore the importance of your organization’s compliance with the Traceability Rule.
  • Are you performing CTEs? These include harvesting, cooling, initial packing, first land-based receiving (food obtained from a fishing vessel), shipping, receiving, or transforming any of the foods on the FTL. If so, specific data must be collected. Do you understand and are you meeting these data collection requirements?
  • Does your organization capture data that is considered a KDE? For example, do you apply lot codes to your products? Do you collect detailed location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information, data points, or additional KDEs you must capture and maintain to meet FDA requirements (e.g., date, harvest crew, common name of the commodity and variety, etc.). The data required is dependent on which of the CTEs you are performing. This guide from the FDA[v] can help determine whether you are collecting all the required data. Once you know what data you are missing, as identified by your gap assessment, you can determine how to best record it (e.g., developing new processes and procedures, implementing a new lot code sticker program).
  • Do you have a sufficient Traceability Plan? Does your Plan cover all the elements required in the Food Traceability Rule? The Traceability Plan must include the following, at a minimum:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how lot codes are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
    • Updates to reflect updated or new practices.
  • What recordkeeping system are you using? Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Can your system handle new requirements? Is required information readily retrievable? While hard copies in binders and Excel spreadsheets can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data. Your gap assessment can help you identify and better understand your needs and requirements prior to investing in an IT solution that helps streamline your traceability process and improve overall compliance efficiency.
  • How are you sharing data? What collaborative activities can you and your suppliers/buyers perform to ensure efficient data sharing? How do you communicate and with what frequency? What systems are your partners using? What is the best way to connect them to enable data sharing? It is important to ensure you have established processes, systems, and methods of communication throughout the supply chain to facilitate the required documentation, information sharing, and collaboration.

The answers to these questions will identify elements that you need to implement to help ensure compliance. Getting started on your gap assessment now affords time for produce companies to identify compliance program gaps, test protocols and verify their effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline.

[i] The Produce Traceability Initiative. https://producetraceability.org/.

[ii] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. June 27, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

[iii] Code of Federal Regulation. Title 21, Chapter 1, Subchapter A, Part 1, Subpart S. July 3, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S?toc=1.

[iv] U.S. Food and Drug Administration. Food Traceability List. March 30, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

[v] U.S. Food and Drug Administration. Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). https://www.fda.gov/media/163132/download?attachment.

New Era of Smarter Food Safety FSMA, FDA
Beltway Beat

Data and Technology in the New Era of Smarter Food Safety

By Food Safety Tech Staff
No Comments
New Era of Smarter Food Safety FSMA, FDA

There is only one week left to submit your comments to the docket on the New Era of Smarter Food Safety. FDA is seeking feedback on topics discussed during the public meeting as well as specific questions they have identified in the topics for consideration document on FDA’s meeting page. FDA encourages anyone interested in submitting comments to
the docket, to please do so by the June 24, 2024 deadline. Comments can be submitted at www.regulations.gov [2] to docket number FDA-2024-N-1744.

Food Traceability and Authentication in the AI Era

By Maria-Eleni Dimitrakopoulou
No Comments

Food traceability provides comprehensive information about a product’s history and origin, facilitating efficient recalls and supply chain management. However, distinct types of food fraud, such as concealment, counterfeit, and mislabelling, pose significant challenges. The integration of Artificial Intelligence (AI) and new regulatory measures, like the FDA’s traceability rule, enhance food safety and authenticity, fostering a more transparent and reliable food supply chain.

In the intricate web of the global food supply chain, ensuring the safety and authenticity of consumables stands as a paramount concern. Food traceability, defined as the ability to provide comprehensive information about the history and origin of a product throughout its journey, emerges as a cornerstone in this endeavour. This meticulous documentation not only facilitates supply chain management but also empowers swift actions such as recalls in the event of safety or quality breaches.

Beyond its logistical benefits, food traceability assumes a pivotal role in safeguarding consumer interests. By serving as a fundamental component of food safety and quality assurance, traceability ensures transparency and accountability at every stage of production and distribution. However, the efficacy of a traceability system is inherently tied to the credibility of its origins, paving the way for the convergence of food traceability and authentication.

Unveiling the Shadows: The Challenge of Food Adulteration

In an era plagued by instances of food adulteration and mislabelling, the imperative for robust authentication mechanisms becomes increasingly apparent. Reports from international and national research bodies shed light on a myriad of cases spanning various food categories, from wine and spirits to olive oil, fish, meat, and beyond. This pervasive challenge underscores the need for stringent standards and regulatory frameworks to combat fraudulence and uphold consumer trust.

Food fraud manifests in several forms, each presenting unique challenges for detection and prevention. For example:

  • Concealment involves hiding inferior or harmful ingredients within a product to avoid detection. An example of this is the addition of melamine in milk to falsely increase protein content readings, which led to a major scandal in China.
  • Counterfeit products replicate and sell a product under the guise of a well-known brand, often with substandard quality. These fake products can range from everyday items like bottled water to high-end goods like wines and spirits. Counterfeiting not only deceives consumers but also damages brand reputations and violates intellectual property rights.
  • Botanical Authentication ensures that plant-based products are derived from the claimed species and not substituted with cheaper alternatives. This is particularly important for products like herbal supplements, teas, and spices. For instance, saffron, one of the most expensive spices in the world, is often adulterated with less expensive substances such as dyed corn stigmas or safflower.
  • Geographical Origin fraud involves misrepresenting the region from which a product originates. Certain regions are known for producing specific high-quality foods and beverages, such as Champagne from France or Parmigiano Reggiano cheese from Italy. Mislabelling products to benefit from these reputations deceives consumers and undermines genuine producers.
  • Substitution entails replacing a high-value ingredient with a lower-cost one. This is common in products like olive oil, honey, and seafood. For example, extra virgin olive oil might be diluted with cheaper oils, or expensive fish species like tuna might be replaced with less costly ones like escolar. This not only cheats consumers but can also pose health risks.
  • Mislabelling involves incorrectly listing ingredients or nutritional information on labels. An example is claiming a product is organic when it is not.
  • Dilution involves adding water or other substances to increase the volume of a product. For instance, diluting fruit juices with water and not declaring it.
  • Unapproved Enhancements involve using unauthorized substances to enhance the appearance or quality of a product. An example is adding unauthorized dyes to make a product look fresher or more appealing.
  • Theft and Resale refers to stealing products and reintroducing them into the market through unauthorized channels. For example, reselling stolen goods without proper storage conditions.
  • Artificial Additives involves using artificial ingredients to mimic the qualities of a natural product. For example, adding synthetic vanilla flavor instead of natural vanilla extraction

The New Traceability Rule of FDA

The Food and Drug Administration (FDA) has introduced a new traceability rule aimed at enhancing the ability to trace the origin of foods throughout the supply chain more efficiently. This rule mandates that companies maintain more rigorous records of their supply chains, focusing on high-risk foods. The implementation of this rule is expected to significantly improve the speed and accuracy of traceability in the event of a foodborne illness outbreak or contamination incident, thus ensuring faster recalls and reducing the risk to public health.

The Dawn of a New Era: Advancements in Food Fraud

As the spectre of food fraud looms large, there arises an urgent demand for sophisticated analytical techniques to authenticate foodstuffs with precision and reliability. Here, the advent of Artificial Intelligence (AI) heralds a new era of innovation. AI-driven algorithms can sift through vast datasets, identifying patterns and anomalies that elude traditional methods. Machine learning models can analyse complex chemical compositions, flagging deviations indicative of adulteration or mislabelling. By harnessing the power of AI, authorities can fortify their efforts in safeguarding consumer interests and preserving the integrity of the global food market.

Charting the Course Ahead: Toward a Safer, More Authentic Future

In the pursuit of food safety and quality, the symbiotic relationship between traceability and fraud, bolstered by AI technologies, emerges as a beacon of hope. By fortifying supply chain transparency and deploying cutting-edge analytical methods, stakeholders can navigate the complexities of the modern food landscape with confidence and integrity. The integration of the FDA’s new traceability rule further strengthens this endeavour, ensuring a safer and more reliable food supply chain for all.

Produce Traceability: 4 Steps to Get Started

By Samantha Humphrey
No Comments

With the effective date for updated traceability recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

On November 21, 2022, the Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). With the effective date for updated recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

Most produce companies are no strangers to the importance of traceability. In fact, the Produce Traceability Initiative (PTI) was created over 15 years ago as a voluntary, industry-wide effort designed to help the industry maximize the effectiveness of current track and trace procedures, while developing a standardized industry approach to enhance the speed and efficiency of traceability systems for the future. The PTI has set dozens of companies throughout North America—ranging from small farms to international retailers—on the path to enhanced traceability and compliance with the FDA’s Food Traceability Rule.[i]

The following steps can help any produce company, whether it currently follows the PTI or not, prepare to meet FDA’s traceability requirements:

  1. Understand the Food Traceability Rule.

While the FDA has had traceability requirements in the past, the FSMA Food Traceability Rule is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one step forward, one step back” traceback approach. The objective of the Rule is to help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.[ii]

In comparing the FSMA Rule to the PTI, a recent PTI press release states that the requirements of the PTI for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements, with major differences stemming from the Traceability Lot Code Source and Traceability Lot Code Source Reference.[iii]

The key elements of the FDA Rule are built into several acronyms:

  • FTL (Food Traceability List): This list identifies the categories of high-risk foods that require additional traceability records under the Food Traceability Rule. The FTL currently comprises the following produce commodities: cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh cut fruits and vegetables. Other non-produce foods on the FTL include cheeses, shell eggs, nut butter, finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads.
  • TLC (Traceability Lot Code): This descriptor, often containing a combination of letters and numbers, is used as a unique identifier for product as it moves through the supply chain. The TLC is to be established by entities that originate, transform, or create food on the FTL. Once a food has been assigned a TLC, the TLC must be included in traceability program records collected at each Critical Tracking Event (CTE) and as a part of all Key Data Elements (KDEs) (see below). The TLC remains the same throughout the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
  • CTE (Critical Tracking Event): CTEs are the events in the food supply chain that require additional recordkeeping. These include harvesting, cooling before initial packing, packing, transforming, shipping, and receiving. At each CTE, the responsible entity must record the TLC.
  • KDE (Key Data Element): KDEs comprise the information associated with a CTE for which a record, including a TLC, must be maintained. Examples of KDEs include location description of the food being harvested; name of the field or growing area where the produce was harvested; date of harvest; quantity and unit of measure of the produce; date when the produce went from harvest, to cooling, to packing, to shipping, etc.
  1. Interpret the Rule and Determine its Applicability.

To determine the Rule’s applicability, it is important to first take an inventory of your operations and products:

  • Do you grow cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, or tropical tree fruits?
  • Do you process fresh cut fruits, leafy greens, or vegetables other than leafy greens?
  • Do you manufacture a product that contains any of the foods listed above?

If the Rule applies (i.e., you answered yes to any of the three questions above), you must:

  • Maintain specific data records (i.e., KDEs) for at least two years.
  • Keep records of all CTEs.
  • Maintain an approved, updated Traceability Plan.
  • Ensure all data is easily accessible so it can be provided to the FDA within 24 hours of a request.

Note that there are a few nuanced exemptions that apply to farms, as noted on this FDA flow chart.[iv]

  1. Perform a Gap Assessment.

Most produce companies are likely capturing at least some of the information needed to comply with the Food Traceability Rule, particularly if they already implement the PTI requirements. Conducting a gap assessment will help identify missing elements that may be required for compliance with FDA’s Rule. The following questions can help guide this assessment:

  • Does your organization already capture data that may be considered a KDE? For example, do you apply lot codes to your products? Do you collect location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information or data points you are missing and how you can gather that data.
  • Do you have a sufficient Traceability Plan? Does it cover all the elements required in the Food Traceability Rule?
  • Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Having a good document/records management system is essential for maintaining and sharing the data required by the Food Traceability Rule.
  • What collaborative activities can you and your suppliers/buyers perform to ensure that data is shared efficiently and encourage compliance?
  1. Create a Plan of Implementation.

The gap assessment will identify elements that you need to implement to help ensure compliance. Use that information to create a game plan, working backwards from the Rule’s January 20, 2026 effective date. Doing so now affords time to test solutions, see how they work in practice, problem solve, and find the right solutions for your organization.

At a minimum the implementation plan must include two key elements that will be vital for compliance:

  • Traceability Plan. Every organization must develop a new (or update an existing) Traceability Plan for collecting the KDEs that are required by the Rule, as outlined in the CFR[v] (see also the FDA example of a Traceability Plan for Farms[vi]). The Traceability Plan must be updated annually, and old plans must be maintained for at least two years. The Traceability Plan must include:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how TLCs are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
  • Document/Records Management System. Produce companies who manufacture, process, pack, or hold foods on the FTL will need to implement a document/records management system to fulfill the Food Traceability Rule’s recordkeeping requirements. While hard copies in binders can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data.

As produce companies work through this process, it is important to remember the objective of the Food Traceability Rule. Ultimately, the Rule will allow the food industry to quickly remove potentially harmful foods from the supply chain and make the entire recall process more efficient. Even if the FTL list does not apply to all your products, your customers may still require that all produce they purchase meet the same requirements as foods listed on the FTL. Creating this end-to-end traceability will save time, money, and most importantly, human lives.

[i] Produce Traceability Initiative. The Produce Traceability Initiative: Working to achieve standardized, electronic (computerized) traceability across the supply chain. September 2011. https://producetraceability.org/wp-content/uploads/2022/03/PTI-Flyer_FNL_v2-2011-10-20.pdf.

[ii] Food and Drug Administration. What you need to know about the Food Traceability Rule: Recordkeeping Information for Produce Farms. June 2023. https://www.fda.gov/media/169510/download.

[iii] The Produce Traceability Initiative. Produce Traceability Initiative (PTI) Releases FSMA 204 Implementation Guidance. February 13, 2024. https://producetraceability.org/produce-traceability-initiative-pti-releases-fsma-204-implementation-guidance/.

[iv] Food and Drug Administration. Exemptions to the Food Traceability Rule. https://collaboration.fda.gov/tefcv13/.

[v] National Archives and Records Administration. CFR Title 21, Chapter I, Subchapter A, Part 1, Subpart S, Traceability Plan. May 21, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S/subject-group-ECFRe6c9096adb572d4.

[vi] Food and Drug Administration. Traceability Plan Example for Farms (§1.1315). November 2023. https://www.fda.gov/media/174057/download?attachment.

Ainsley Lawrence
Allergen Alley

Food Allergen Management in Manufacturing: Best Practices and Regulatory Compliance

By Ainsley Lawrence
No Comments
Ainsley Lawrence

Minimizing the risk of contamination is a must if you work in food manufacturing. Accidentally including allergens in your products can cause harm to consumers, undermine your brand image, and lead to hefty lawsuits.

Even major food industry brands like McDonald’s fall foul of food safety laws from time to time. Recently, a man with a dairy allergy was allegedly served cheese in his Big Mac1, resulting in anaphylactic shock. This caused a large lawsuit and could damage the global food giant’s reputation.

You can take steps to stay in line with regulations and best practices by training your staff and implementing proper procedures. This will reduce the risk of human error and help you produce food that is both tasty and safe for consumers.

Food Safety Modernization Act

Most people think of food contamination as a thing of the past. However, 1 in 6 Americans2 fell ill due to foodborne diseases last year. This led to 128,000 hospitalizations and 3,000 deaths. The FDA’s Food Safety Modernization Act (FSMA) seeks to end this issue by bringing food manufacturing standards into the modern age. This means you may need to revise your approach to manufacturing to stay on the right side of changing guidelines. At its core, the FSMA includes:

  • Preventive Controls for Human Foods: Since 2015, food manufacturers have been required to produce a food safety plan. This plan should include key details like potential hazards and risk-mitigation strategies that are currently in place.
  • Third-Party Accreditation: Receiving a third-party authentication can keep you up to date with changing guidelines. Similarly, only working with suppliers who have been verified via third parties who work to ISO/IEC standards ensures that allergens don’t enter your facility from suppliers.
  • Preventing Intentional Adulteration: No employer wants to believe that their employees would intentionally harm consumers — but it does happen. The FSMA ruling against intentional adulteration means that you can seek support from the intelligence community if you suspect that a stakeholder is intentionally contaminating your supply.

These FSMA regulations aren’t exhaustive and should be seen as the bare minimum. You’ll still need to take proactive steps to improve communication on the food plant floor3 and should implement policies like proper labeling to keep contaminants and allergens separated.

Proper Labeling

If you’re producing food for public consumption, you must properly label your food. Failing to declare that allergens may enter a certain product will land you in legal trouble and will put consumers at risk. Rather than risking an allergic reaction, follow FDA labeling guidelines4 which include:

  • Clearly labeling the eight major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans).
  • Including the source name of foods (for example, the source name of whey is milk, meaning your label should include “whey (milk)”).
  • Provide advisory statements like “may contain [allergen]” and “produced in a facility that also uses [allergen].”
  • Conduct regular testing and monitoring of products and processes to ensure that allergens have not entered the batch.

Taking these steps minimizes the risk of labeling errors and protects consumers. This is particularly important if you want to produce a product that is specifically allergen-free (for example, gluten-free or dairy-free). Failing to declare ingredients properly puts consumers at risk and will land you in hot legal water.

Segregating Allergens

Managing potential allergens is crucial if you work in a food manufacturing plant that produces multiple products. Failing to properly segregate allergens undermines your labeling system and increases the risk of cross-contamination between workstations.

You can minimize the risk of allergens entering the system by using simulations to improve business processes5. Virtual simulations are capable of generating scenarios that you may not have thought of but are likely to occur. You can also use constructive simulations to visualize what might happen should an allergen make its way into the supply. This is particularly important when onboarding new employees who may not understand the risk that allergens present to the food production process.

You can also use emerging technology to improve production6 and reduce the risk of contamination. For example, as your firm grows, you may want to invest in AI and advanced robotics. Robotics can react quickly to changing demand and are less likely to inadvertently spread allergens throughout your supply. This is particularly important when carrying out repetitive tasks, like filling pre-packaged sandwiches or seasoning foods. Automated robots can take care of these mundane tasks, leaving human workers to focus on more creative tasks.

Some food manufacturers, like Walmart, are also using blockchain technology to trace and track contamination. This can improve your crisis management plan7 and bolster operational resilience. Your crisis management team leader can tap into tech to improve communications and simulate potential breaches. This will help you practice your crisis management plan and will ensure that you’re able to pinpoint errors to learn from in the future.

Sanitary food handling

Sanitation Procedures

Regularly sanitizing your workspace is crucial if you want to produce clean, allergen-free goods. This applies to your people, too, who may inadvertently bring allergens in with them when they arrive at work or move between stations.

However, you can’t expect regular handwashing to be enough. Instead, embrace the digital revolution and use data8 to clean up your production line. This will improve reporting and ensure that compliance guidelines are followed at all times. For example, if you suspect that your employees are not washing their hands thoroughly enough, you can use digital products to track employee handwashing and time folks while they apply hot, soapy water.

Digital tracking can also alert you to potentially unclean workstations. For example, if you work in a bakery and typically produce most of your dough before dawn, a digital program can track the contaminants that have entered the workspace in order to produce your bread or baked goods. This will alert you to potential allergen risks and ensure that any workstation that has used an ingredient like gluten is properly sanitized in a timely fashion.

Staff Training

Properly training your employees is key to minimizing contamination risk and staying on the right side of regulatory compliance laws. A proper approach to training will empower employees and help them understand the potential risks involved with food manufacturing.

However, proper training doesn’t mean that you should force your workers to sit through hours of PowerPoint. Instead, train smarter, not harder9 by conducting training that is:

  • Legitimate. Before asking folks to engage in further training, ask yourself whether or not you are qualified to speak on the subject. If not, consider bringing in a speaker who is well-respected in the food safety industry.
  • Authentic. Build a culture of trust and engagement at your workplace by working with speakers and programs that are accredited and up to date with compliance law. This will convince folks that your speakers are worth listening to and that your training programs are worth completing.
  • Engaging. Don’t force your employees to sit through lengthy seminars without an opportunity to engage. Instead, encourage participation by creating engaging training programs that help folks learn skills as they go.
  • Simplistic. Food safety can be complex. Cut through this complexity by giving folks simple, actionable steps to take. This will minimize the risk of folks forgetting your policies and will empower employees who want to improve safety at work.

These training principles are well-established in the food production and safety world. Even simple changes, like including a quiz or mock preparation test, will pique people’s interest and ensure that employees are engaged when receiving training. If you fail to run engaging, intelligent training, you put yourself at greater risk of contamination during production.

Conclusion

Following FDA guidelines should keep your consumers safe by minimizing the risk of an allergen entering your workspace. However, you’ll need to go above and beyond minimum requirements if you want to completely eliminate the risk of contamination. Get the ball rolling by embracing the digital revolution and using automation or robotics to handle more mundane tasks. This empowers employees and reduces the risk of human errors during production.

References:

  1. https://www.nbcnews.com/news/us-news/man-dairy-allergy-sues-mcdonalds-alleging-cheese-big-mac-caused-anaphy-rcna137252
  2. https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
  3. https://foodsafetytech.com/column/improving-communication-on-the-food-plant-floor/
  4. https://www.fda.gov/food/food-labeling-nutrition/food-allergies
  5. https://www.lucidchart.com/blog/business-process-simulation
  6. https://foodsafetytech.com/column/four-influential-technologies-changing-food-manufacturing/
  7. https://riskonnect.com/business-continuity-resilience/crisis-management-plan-create/
  8. https://foodsafetytech.com/column/managing-food-safety-testing-and-sanitation-data-should-be-easier/
  9. https://foodsafetytech.com/feature_article/train-smarter-not-harder-utilizing-effective-training-to-empower-employees/
Guy Yehiav

Driving Restaurant Food Safety with IoT-Enabled Digitalization

By Guy Yehiav
No Comments
Guy Yehiav

Restaurant operators have a critical responsibility to safeguard the health of their customers. Mitigating foodborne illness must be top of mind today more than ever. The potential risks are too severe to overlook, especially with new FSMA 2026 regulations on the horizon.

Take Netflix’s critically acclaimed 2023 documentary Poisoned for example. It cast a light on the consequential impact that poor food safety can have on restaurant customers. More than 48 million Americans suffer from foodborne illness every year, but it’s not always just a minor stomachache or temporary irritable bowels. In some cases, we’re talking about a matter of life and death. Dr. Darin Detwiler, LP.D., a nationally recognized food regulatory leader featured in the Netflix documentary, learned this reality firsthand after the tragic passing of his 16-month-old son from an E. coli infection caused by contaminated ground beef at a Jack in the Box fast food restaurant in 1993. And his family is not alone — there are 3,000 U.S. deaths from foodborne disease annually, with 1 in 3 afflicting children.

There’s also a business continuity component to consider. While no monetary value can be placed on human life, restaurants must understand the financial and brand reputational risks associated with poor food safety. Jack in the Box suffered approximately $160 million in legal penalties and lost sales as a result of the E. coli outbreak — and that was in the early 1990s. That is equivalent to about $350 million today. For a more recent example, Chipotle’s 2016 E. coli outbreak caused 43 restaurants to close, eroded over 45% of the company’s stock value, and resulted in a $6 billion loss in market cap. It underscored the criticality for restaurants to execute on food safety and the financial consequences of failing to do so.

In 2024, safeguarding restaurant customers from foodborne illness will require a shift away from legacy approaches in favor of IoT-enabled digitalized food safety strategies. The integrated use of IoT Sensing-as-a-Service frameworks throughout restaurant facilities provides the operational efficiency, real-time visibility, and data-driven decision making essential to preserve customer health. These frameworks combine IoT sensing and monitoring functions with the power of AI-driven prescriptive analytics to automate fundamental food safety processes such as condition monitoring, task management, compliance reporting, and asset protection. These tools enable the average person to comply with regulation and keep the client safe.

Compounded at scale, they enable restaurant operators to foster a culture of food safety accountability at every level of the enterprise and align with the oncoming realities of FSMA 2026.

FSMA 2026: A New Era on the Horizon

The FSMA 2026 regulations have raised the stakes for restaurant operators to enhance their digital food traceability capabilities. The new rulings will require them to provide verifiable data records of Critical Tracking Events (CTEs) across key hand-off-points of the food chain where products are at risk of spoilage. For example, that could be seafood containers transferred from a distribution truck to a back-house freezer or leafy greens inside a salad bar right before the point of consumption.

Restaurant operators must be able to prove that FSMA 2026 products remained in optimal conditions during critical control points. They will also be required to present an electronic traceability plan that clearly describes their procedure for maintaining records for the foods they handle. In the case of a foodborne illness outbreak at the restaurant, the operator must be able to present traceability records to the FDA within 24 hours if requested.

Maintaining compliance at this granular level requires agile food chain technology. Operators who haven’t invested in digitalization yet should be prioritizing it now ahead of FSMA 2026. It’s impossible for an enterprise to manually record accurate FSMA data across 40 or 50 locations without automation. Manual data logs are often siloed, incomplete, and hindered by human error. Adopting IoT Sensing-as-a-Service frameworks will be critical to preparing for the uncertainty ahead.

Real Time Condition Monitoring

IoT Sensing-as-a-Service frameworks empower operators to collect, analyze, and act on inventory data for a stronger food safety posture. Placed inside a restaurant’s food storage assets, IoT sensing and monitoring devices allow employees to remotely monitor their environmental settings in real time to confirm HACCP compliance standards are maintained. The devices also monitor the performance of those storage assets, automating the detection and prediction of maintenance issues that could lead to an illness-causing event. 

The raw data collected from each individual IoT device flows through a prescriptive analytics platform with continuous telemetry feedback loops that identify potential risks and prescribe mitigation actions. Based on the data-driven insights, restaurants can take the proper steps to ensure their products remain safe to consume.

Leveraging Digital Checklists

Digital checklists are another key component of the IoT Sensing-as-a-Service framework, helping to simplify the complexities of task management within a hectic back-of-house restaurant environment. Serving as an operational execution platform, these checklists enable operators to gain unprecedented visibility into employee efficiency and food safety initiatives. Managing workflows for multiple locations is exceedingly easier, allowing operators to monitor enterprise-wide food safety as quality performance alongside location-specific metrics. And with access to the right prescriptive tasks at the right times, employees can proactively enhance the safety of high-risk menu items such as poultry, leafy greens, and eggs that require stringent temperature-sensitive storage conditions.

In the past, restaurants would respond to incidents after the fact while leveraging unreliable paper-based records to explain what had gone wrong. While this level of manual task management is near impossible to analyze at scale, digital checklists help realize the benefits of a proactive food safety strategy, generating visibility into compliance and operational procedures, regardless of scale, while unlocking insights that prevent foodborne incidents from arising in the first place.

Rick Biros
Biros' Blog

In Defense of FSMA

By Rick Biros
No Comments
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.