Tag Archives: traceability

Traceability in food manufacturing, Honeywell
Beltway Beat

Produce Traceability: Uncovering the Gaps in Your Program

By Samantha Humphrey
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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.

Produce Traceability: 4 Steps to Get Started

By Samantha Humphrey
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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

Implementing Traceability Systems in Restaurants

By Ainsley Lawrence
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Ainsley Lawrence

According to the Centers for Disease Control and Prevention (CDC), one in six Americans fall ill after consuming contaminated food or beverages, resulting in approximately 3,000 fatalities from foodborne illnesses per year. This highlights the critical need for restaurant traceability systems to ensure food safety and maintain quality standards. Without proper transparency, it becomes difficult to identify the source of contamination and take necessary actions to prevent the spread of foodborne illness.

The Benefits of Traceability Systems

The primary reason restaurants implement traceability systems is to prevent the spread of foodborne illnesses. Traceability enables swift identification and removal of contaminated products from the supply chain.

Through detailed tracking of food production processes, including sourcing, processing, and distribution, traceability allows for targeted recalls, preventing the spread of harmful pathogens and ensuring consumer protection. Additionally, this system facilitates accountability among food producers, encourages adherence to stringent safety standards, and fosters trust and confidence in the food industry.

By tracking the origin of every ingredient and monitoring its handling and storage conditions, restaurants can ensure that all their products meet set quality criteria. This can include freshness, nutritional value, and sensory characteristics.

Effective Internal Communication

Traceability systems also allow for more effective communication within a restaurant’s internal organization. Using digital communication tools such as electronic logging devices (ELDS) and connected cameras, employees and managers can coordinate tasks efficiently and oversee global teams. These tools also offer real-time footage of food production processes, serving as visual records for audits. Efficient communication ensures all employees are adequately trained in technical processes, reducing the risk of errors, and boosting confidence in the system. Consequently, the establishment is better equipped to provide exceptional customer service, as they can pinpoint where ingredients or foods are in the distribution and production process.

Promoting Transparency

With the rise of food allergies and dietary restrictions, people want to know what ingredients are in their food and where they come from. Traceability enables precise identification of allergens by tracing the journey of ingredients from their source to the final product, allowing for accurate labeling and risk assessment.

For instance, a bakery can use traceability to track the origin of nuts used in its products, ensuring thorough allergen labeling and preventing cross-contamination for customers with nut allergies. This attention to detail helps to build trust and transparency with customers, who can then make informed decisions about what they consume.

These benefits make traceability systems an essential tool for restaurants looking to maintain food safety and quality standards while meeting consumer demands for accountability in the food industry.

Challenges in Implementing Traceability Systems

While applying traceability systems can significantly benefit restaurants, there are some hurdles that the food industry faces in maintaining them. This is why food industries need to implement food management systems to overcome challenges such as:

  • Cost: Implementing traceability systems can be costly, especially for small businesses. Audits, preparations, and maintenance require financial resources that may not always be readily available.
  • Keeping up with standards: The food industry must comply with various standards and regulations, which can be challenging for restaurants. Some standard guidelines include the Food Safety Modernization Act (FSMA) and the Global Food Safety Initiative (GFSI), which have strict requirements for record-keeping, documentation, and reporting.
  • Resistance to change: Many restaurants still rely on traditional manual processes for tracking and record-keeping, making it difficult to transition to automated systems. This may be due to a lack of awareness or reluctance to change ingrained practices that have existed for a long time.
  • Technical challenges: Some individuals may be intimidated by new technology, making implementation and training complex. Lack of technical support can cause confusion in understanding new systems, and resistance to digital tools.

Despite these obstacles, the benefits of traceability systems make it essential for foodservice businesses to address these challenges and ensure they meet current standards and regulatory requirements. Following are some of the key technologies to investigate as you work to a more effective traceability system.

Tools To Enhance Traceability

Smart Labeling Solutions. Smart labeling systems use data matrix codes or RFID technology to monitor products throughout the supply chain. The codes can be scanned at various checkpoints, providing real-time data on the product’s location and condition. This improves data collection, reduces human error, and enhances security by ensuring only authorized personnel handle the products.

Smart labels also enable restaurants to provide customers with detailed information about their food, such as allergens and nutritional content, promoting transparency and trust. Product tracing can also lessen restaurant product recall costs, as the affected products can be quickly identified and contained.

IoT Asset Tracking. The Internet of Things (IoT) technology can aid in safe distribution, visibility, and reliability in restaurants. Through vendor compliance monitoring, damage detection, theft reduction, and spoilage detection, IoT can enhance data collection and help prevent food safety issues. This technology also enables real-time monitoring of products’ temperature and conditions during transportation, reducing the risk of spoilage or contamination. Moreover, close monitoring of these conditions makes it easier to identify and address any guidelines or compliance violations.

With advanced technology, effective processes, and a focus on disclosing accurate information, restaurants can implement more effective traceability systems to meet consumer demands and encourage confidence in the food industry.

Matthew Taylor

Are You Ready? Preparing for FSMA 204

By Matthew Taylor
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Matthew Taylor

With millions of people in the U.S. getting sick each year from foodborne illness, the FDA is continuing to transform the nation’s food safety system with more stringent rules and regulations. In 2011, the Food Safety Modernization Act (FSMA) was signed into law, and consequently, several rules have been finalized to implement the act and ensure food safety across different points in the global supply chain.

The FDA’s Requirements for Additional Traceability Records for Certain Foods, also known as the Food Traceability Final Rule or FSMA 204, establishes additional recordkeeping requirements for entities that manufacture, process, pack or hold foods on the Food Traceability List. The list includes specific foods, such as specific cheeses, eggs, cucumbers, herbs, leafy greens and more, for which extra recordkeeping requirements are reasonable and necessary to protect public health.

The rule was finalized by the FDA on November 15, 2022. It will be enforced beginning January 20, 2026, with routine inspections anticipated to start in 2027, meaning businesses must prepare now to comply with the new requirements.

The goals are to identify and remove potentially contaminated food from the market more quickly, and as a result, prevent the spread of foodborne illnesses and/or fatalities.

Understanding the Food Traceability List

The FDA’s identified foods can be found on the Food Traceability List (FTL). FSMA 204 uses an established set of metrics known as Key Data Elements (KDEs) that relate to various supply chain occurrences known as Critical Tracking Occurrences (CTEs). The CTEs are:

  • Harvesting
  • Cooling
  • Initial Packing (applies to Raw Agricultural Commodities not obtained from a fishing vessel)
  • First Land-Based Receiver (applies only to seafood)
  • Shipping
  • Receiving
  • Transformation

If an entity uses any of the above CTEs for any food on the FTL, as well as food that uses an ingredient that remains in the same form (e.g. fresh) on the list, it must comply with the additional recordkeeping requirements.

Preparing for FSMA 204

FSMA 204 became operative in January 2023, 60 days after the publication of the final rule in November 2022. While businesses have three years to become fully compliant (until January 20, 2026), starting the process early is highly recommended as several of the requirements, such as having an established food traceability system, take both time and effort. Meeting the deadline can be extremely challenging if preparations are put off until just before the compliance date.

To prepare for FSMA 204, first, take the time to thoroughly review and understand the rule. Carefully read through the FTL and its overview of ingredients and finished products. Then, make sure that you understand any exemptions that apply to your business.

The next step should be to consult the FDA’s reference guide on CTEs and KDEs to determine which KDEs you must record. Various sets of KDEs may need to be recorded depending on your specific business activities. For example, a food processor could fall under the categories of receiver, transformer, and shipper since it physically acquires products from a supplier, then combines, repackages, relabels, or otherwise transforms the food before shipping it to clients.

In addition to capturing the KDEs, businesses should:

  • Create and maintain a traceability plan.
  • Maintain records in the form of either the original printed records, electronic records, or true copies. (Records must be legible and stored to prevent loss or deterioration.)
  • Ensure traceability records are sent to the FDA within 24 hours of their request (or within a reasonable time to which the FDA has agreed), including any information required to comprehend the data or records. When required to assist during an outbreak, recall or other public health danger, you must deliver an electronic sortable spreadsheet containing pertinent traceability data to the FDA within 24 hours of a request (or within a reasonable timeframe to which the FDA has consented).

Traceability Plan Must-Haves

The food traceability plan should include all procedures used to maintain traceability records, including detailing the format and location of these records in the business. It should also include procedures used to identify foods on the FTL and the subsequent CTEs.

Other key items to include are a process on how traceability lot codes are assigned, points of contact for questions on the traceability system and its records, and supporting documents such as a farm map that indicates the location of the growers or raisers of the food on the FTL (other than eggs). The map must include the position and name of each field or growing area, as well as other details required to pinpoint the sites. 

Next Steps

Preparing for FSMA 204 and meeting the requirements can be overwhelming. Several third-party organizations are offering support services. Additionally, the FDA has several resources located on its website, including Frequently Asked Questions, a webinar recording and more.

For businesses unsure about how the rule applies to them and their products, NSF offers an Initial Scoping Workshop that includes a virtual session, which involves reviewing the ingredients and finished products compared to the FTL, a document check (e.g. of the traceability plan), confirmation that all relevant stakeholders have been captured, and access to a video recording explaining the principles of FSMA 204’s traceability requirements. A recommendation will also be made if a FSMA 204 Readiness Assessment is needed.

Businesses who already know their products fall under the FTL can opt to start with a full FSMA 204 Readiness Assessment, which ensures you have taken all the steps necessary and helps you identify any corrective actions/controls needed to ensure compliance with the rule.

Effectively communicating the food traceability plan and coaching supply chain partners on new processes is a critical component to meeting compliance. Label harmonization must be completed to properly track and secure the required information from suppliers.

Though paper records are permitted under the rule, businesses should consider leveraging technology to assist them with complying with the requirements. Consider investing in a platform that can automate data gathering and securely save information so it can be easily retrieved if needed. On-demand traceback and trace forward features are especially important, as in the event of an investigation or recall, immediate product tracing capabilities are essential.

While FSMA 204 will require entities across the food industry to comply with the new requirements, it will contribute to a stronger and more resilient global food supply chain.

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Proposed Collaborative for FSMA 204 Compliance Seeks Industry Support

By Food Safety Tech Staff
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Collaboration Graphic

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

Eric Marshall, Leavitt Partners
Eric Marshall

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

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

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

Eric Edmunds, Acheson Group
Eric Edmunds

The goal of the public-private partnership is to:

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

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

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

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

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Sayed M Naim Khalid

The Imperative for an Integrated Food Safety Management System

By Sayed M Naim Khalid
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Sayed M Naim Khalid

As the global food industry continues to evolve, the importance of ensuring food safety has never been more critical. Various standards and certifications, such as GFSI, Organic, Global GAP, HACCP, and ISO standards, have been established to address different aspects of food safety. However, the proliferation of these diverse standards pose a significant challenge — especially for small businesses — in terms of cost, complexity, and overall compliance. In this article, we will explore the need for an integrated food safety management system (FSMS) that consolidates these standards into a comprehensive and unified framework.

Current Challenges in Food Safety Standards

The food industry is subject to a multitude of regulations and standards, each designed to address specific concerns related to food safety. The Global Food Safety Initiative (GFSI) aims to harmonize and strengthen food safety standards across the supply chain. Similarly, standards like Organic, Global GAP, HACCP, and ISO provide guidelines for organic production, agricultural practices, hazard analysis, and quality management systems, respectively.

While these standards individually contribute to enhancing food safety, their coexistence often imposes a heavy burden on businesses, particularly smaller ones. Each standard necessitates a separate certification process, involving costs related to preparation, audits, and ongoing maintenance. This fragmented approach can be overwhelming for businesses, leading to inefficiencies and potential gaps in compliance.

Cost Implications for Small Businesses

Small and medium-sized enterprises (SMEs) in the food industry face a unique set of challenges when it comes to adhering to multiple food safety standards. The financial implications of obtaining certifications for each standard can be prohibitive. For instance, a small-scale food producer dealing with organic products may also need to comply with GFSI standards for global market access.

Certification costs — including consulting fees, documentation, and audit expenses —  quickly accumulate. Moreover, the need for ongoing compliance monitoring and updates can strain the already limited resources of smaller businesses. This situation raises concerns about the equitable access to global markets for businesses of all sizes.

The Role of an Integrated Food Safety Management System

The call for an integrated FSMS is rooted in the idea of streamlining and unifying the various standards to create a more accessible and efficient framework. By integrating these standards, businesses could achieve a single certification that covers multiple aspects of food safety, reducing the financial and administrative burden.

Integration can lead to a more cohesive approach to food safety, eliminating redundancies and ensuring a holistic understanding of potential risks throughout the supply chain. This not only simplifies the certification process but also facilitates better communication and collaboration among stakeholders, including producers, processors, distributors, and regulators. Benefits of an integrated FSMS include:

  • Cost Efficiency. An integrated FSMS would significantly reduce the costs associated with multiple certifications. Businesses can allocate resources more efficiently, making certification attainable for a broader range of enterprises.
  • Simplified Compliance. Streamlining standards into a unified system simplifies compliance efforts. Businesses can focus on meeting a comprehensive set of requirements rather than navigating the intricacies of various individual standards.
  • Enhanced Food Safety. Integration ensures a more comprehensive and interconnected understanding of food safety risks. This can result in a more effective preventive approach, addressing potential hazards at various stages of the production and distribution process.
  • Global Market Access. A single, globally recognized certification can facilitate market access for businesses, especially SMEs. This reduces barriers to entry and fosters fair competition in the global marketplace.
  • Improved Collaboration. Stakeholders across the supply chain can better collaborate when operating under a common framework. Enhanced communication and information sharing contribute to a more resilient and responsive food safety ecosystem.
  • Adaptability to Emerging Challenges. An integrated FSMS can be designed to incorporate emerging challenges and adapt to evolving risks in the food industry. This flexibility ensures that the system remains relevant and effective over time.

Challenges in Implementing an Integrated FSMS

While the benefits of an integrated FSMS are evident, the transition from the current fragmented system to a unified framework is not without challenges. Some potential hurdles include:

  • Resistance to Change. Stakeholders accustomed to existing standards may resist the shift towards integration. Overcoming resistance through education and awareness campaigns is crucial for successful implementation.
  • Technical Harmonization. Ensuring technical harmonization across different standards requires meticulous planning and collaboration. Consensus on common terminology, risk assessment methodologies, and other technical aspects is essential.
  • Regulatory Alignment. Coordinating with regulatory bodies to align an integrated FSMS with existing regulations is necessary. This involves addressing legal and regulatory challenges to ensure widespread acceptance.
  • Resource Allocation. Developing and implementing an integrated FSMS requires significant resources. Small businesses, in particular, may need support and incentives to make the transition feasible.
  • Global Acceptance. Achieving global acceptance of an integrated FSMS may take time. International cooperation and agreement on common standards are vital to ensure recognition across borders.

The need for an integrated food safety management system is evident in the face of an ever-evolving food industry. As standards such as GFSI, Organic, Global GAP, HACCP, and ISO play crucial roles in ensuring food safety, their integration into a comprehensive framework is imperative. The benefits, including cost efficiency, simplified compliance, enhanced food safety, global market access, improved collaboration, and adaptability to emerging challenges, make a compelling case for the adoption of an integrated FSMS.

While challenges in implementation exist, the long-term advantages for businesses, consumers, and the industry as a whole outweigh the difficulties. Governments, regulatory bodies, industry associations, and businesses should collaboratively work towards the development and adoption of an integrated FSMS that strengthens food safety practices, fosters innovation, and promotes equitable access to global markets. In doing so, the global food industry can move towards a more unified and resilient future, ensuring the safety and quality of food products for generations to come.

Food Safety Consortium Conference & Expo

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The Food Safety Consortium Conference, presented by Food Safety Tech and The American Frozen Food Institute (AFFI) will take place October 20-22, 2024, at the Crystal Gateway Marriott, Arlington VA directly across the Potomac River from Washington, DC. The Program starts with several pre-conference workshops and training which leads into two full days of high-level panel discussions and educational presentations.

Jim Jones, FDA

Jim Jones to Keynote 2024 Food Safety Consortium in October

By Food Safety Tech Staff
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Jim Jones, FDA

Food Safety Tech is thrilled to announce that James (Jim) Jones, Deputy Commissioner for Human Foods at FDA, will be the keynote speaker for the 2024 Food Safety Consortium, which will be held October 20-22 at the Crystal Gateway Marriot in Arlington, Virginia. Jones joined the FDA in September 2023 as the agency’s first Deputy Commissioner for Human Foods.

Now in its 12th year, the Food Safety Consortium brings together food safety and quality assurance professionals for education, networking and discussion geared toward solving the key challenges facing the food safety industry. In addition to two days of educational presentations and panel discussions, the Consortium will offer full-day pre-conference workshops, focused on topics including auditor training and food safety culture design, on Sunday, October 20.

This year’s session highlights include:

Navigating Global Food Systems: Insights and Strategies for Compliance with FDA’s Food Traceability Rule

Presenters: John Crabill, Director of Food Safety & Quality, Chipotle; Adam Friedlander, Policy Analyst, Coordinated Outbreak Response and Evaluation (CORE) Network, FDA; Julie McGill, VP of Supply Chain Strategy & Insights, Trustwell; and Sara Bratager, Sr. Food Safety & Traceability Scientist, Global Food Traceability Center at IFT

Are you the weakest link in the supply chain? Steps for bulletproofing your facility to become a major supplier

Presenters: Jorge Hernandez, VP of Quality Assurance, The Wendy’s Company; Tyler Williams, President, ASI

Next Level Preventive Controls

Presenter: Cathy Crawford, President, HACCP Consulting Group

Understanding Corrective Actions, Nonconformities and Root Cause Analysis

Presenter: Heather McLemore, Senior Accreditation Officer, A2LA

View the full agenda here.

Demonstrating Food Safety Culture

Presenters: Tia Glave and Jill Stuber, Co-Founders, Catalyst, LLC

The Internal Audit: Going Beyond the Certificate

Presenter: Cameron Prince, Executive VP, Regulatory Affairs, The Acheson Group (TAG)

Millions of Chemicals…But Which are Reasonably Likely to Occur?

Presenter: Tracie Sheehan, Technical Services, Mérieux NutriSciences

In-person and virtual registration available. Learn more about registration options.

Event Hours

Sunday, October 20: 8:30 am – 5:00 pm (Pre-conference Workshops)

Monday, October 21: 8:00 am – 6:30 pm

Tuesday, October 22: 8:30 am – 3:45 pm

Register now.

For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales.

About the Food Safety Consortium

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of its educational content. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore high-level educational tracks, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

 

Emily Newton, Revolutionized Magazine

6 Ways IoT Asset Tracking Ensures Safe Distribution and Better Traceability

By Emily Newton
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Emily Newton, Revolutionized Magazine

Internet of Things (IoT) sensors are being used in industries across the spectrum, and their potential is far from being realized. The data provided via IoT asset tracking technologies, in particular, can enhance traceability and product integrity, leading to safer food and reducing costly losses. Following are six ways IoT tracking sensors support food safety, traceability and accountability.

Vendor Compliance

Adulteration occurs more often in the supply chain than any professional cares to admit. Some experts estimate it has a $50 billion annual impact on the food industry. Whether motivated by financial gain or product shortages, opportunistic intermediaries will take advantage of poor food traceability and make substitutions, dilutions or falsifications.

To prevent bringing adulterated products to market and keep consumers safe, manufacturers must hold their third-party vendors accountable at every stage of the distribution process, and IoT asset tracking sensors can help. They have the ability to record shipment movements in real time, so companies can ensure that their products and raw materials arrive and remain in the right places at each step in the chain.

Further, manufacturers can reduce the chances of product tampering by using IoT sensors that alert you when someone damages packaging. Bad actors are much less likely to commit food fraud when they know highly sophisticated technology is monitoring their actions and movements.

Damage Detection

Food products, especially those in the cold chain, can bruise, break and flatten relatively quickly, causing financial losses. For instance, grain loses significant value when damaged due to improper handling. Through a combination of IoT sensors and sensing nodes that can track the condition of products and provide relevant, real-time updates, companies can ensure their shipments stay intact throughout distribution and transportation.

Theft Reduction

Cargo theft is a significant problem that’s relatively new to the food industry. According to the FBI, it costs supply chain vendors and retailers up to $30 billion annually. While thieves have historically targeted electronics or high-cost imports, food inflation is making food products a top target as of 2023.

Industrial IoT sensors improve food traceability by tracking a shipment’s movement through the supply chain. They can provide real-time location data or update food-manufacturing professionals when the product reaches a particular destination. Companies can use this data to pinpoint sources of cargo theft, delays or mishandling, increasing product safety and reducing loss.

Spoilage Detection

Spoilage claims 33% of food products manufacturers produce, resulting in over $1 trillion in losses annually. This figure probably isn’t surprising for professionals working in the cold chain, as transportation condition management is incredibly complex and expensive.

Even if food appears fine for human consumption, undetected issues can be catastrophic down the line. A single recall costs a food company over $10 million on average, not accounting for lost sales or reputational damage.

With IoT asset tracking, industry professionals can monitor temperature, humidity and chemical compounds to improve the integrity of their products and ensure safe distribution. They can place sensors inside their vehicles or in packaging to monitor all changes.

Since these sensors provide a complete temperature and humidity account, professionals can even collect data for future use to forecast potential losses when conditions become abnormal. This allows companies to take action quickly to prevent spoilage, dramatically reducing the chances of a recall.

Enhanced Data Collection

An IoT sensor utilizing radio frequency identification (RFID) can collect a massive amount of data on distribution and transportation conditions that industry professionals can gather and store for future use. This information provides insights into route optimization and/or sources of contamination. With the addition of artificial intelligence, these sensors can maximize food traceability by validating everything passing through a gate.

If retailers wish to make some of this information available to end users, they can publish it or use specialized barcodes. Customers will get to review the origin of the raw materials and products, providing increased awareness of where their food comes from and the path it took to get to their store.

Faster Traceability

One in six people every year become sick due to a foodborne illness. It is up to manufacturers, distributors and retailers to ensure product quality and prevent these illnesses. When outbreaks do occur, it is up to manufacturers—both morally and legally—to trace that product and remove it before others are affected.

Luckily, IoT devices meet all the necessary regulatory criteria. RFID and other technologies can trace products in real time and alert the relevant parties of any significant changes. For example, they could track a perishable produce shipment and notify retailers and manufacturers of an extreme temperature spike.

Since these sensors can send out instantaneous alerts, nearby professionals can immediately respond before product becomes contaminated or spoils. Whether they are alerted to temperature fluctuations, suspected tampering or imminent spoilage, they can move quickly to address the concern.

IoT asset tracking is an innovative approach to common industry pain points. It addresses the food sector’s unique needs, taking perishables, food compliance and adulteration into account. With such significant food traceability improvements, manufacturers, distributors and retailers will have a much easier time coordinating their operations to increase safety, speed to market and the quality of their products.

Matt Brown
FST Soapbox

Technology in the Food Chain: Insights from the IFT 2023 Traceability Challenge Report

By Matt Brown
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Matt Brown

In a report released in May of 2023, the Institute of Food Technologists (IFT) offered an encouraging and attainable outlook for cooperative and effective functionality throughout the global food supply chain. And with traceability as the primary goal in this diverse landscape of users, challenges and solutions abound. Less a snapshot of where we have been, this report is a helpful guide to where we are going and how best the industry will achieve compliance to the Food Safety Modernization Act (FSMA) by January 20, 2026.

Traceability Challenges in a Global Food Supply Chain

Traceability is a common goal in all industries. But when food and beverage is your bread and butter, the ability to trace a single ingredient can be a matter of life and death. Based on findings in a 2006 study, the Center for Disease Control (CDC) reported the following yearly totals: 37.2 million cases of foodborne illnesses; 228,744 resulting hospitalizations; and 2,612 deaths.[1] In order to improve the landscape of health and safety in the food and beverage industry, the IFT in conjunction with the FDA embarked on a study[2] of how low- or no-cost technology could improve traceability for businesses within the global food supply chain.

One of the greatest challenges in achieving uniform traceability lies in the vastness within the food supply chain itself. Those beholden to compliance are defined as “all persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List (FTL).[3]” And this rule applies to all foods that are consumed in the U.S. market, not just those grown in the U.S. All laborers—planters, harvesters, processors, handlers, packers, distributors, shippers and retailers—who interact with any item on the FTL[4] must be recorded and tracked according to FDA guidelines. These guidelines include procedural protocol for food handling as well as timelines for processing and documentation. Whether the starting point of a single ingredient is stateside or overseas, it generally travels several places before arriving on a grocery store shelf or appearing on a restaurant’s menu.

Within this huge network of players lies the next challenge: economic and technological diversity. While economy and technology are not always one and the same, the typical overlap is demonstrated in the specific case of a head of lettuce. On one end of the supply chain continuum, a head of lettuce begins its journey in a field. There are no handheld scanners or databases in this lettuce’s origin story. There is only the hot sun, an irrigation system, and hard-working people laboring up and down the rows of lettuce. Now flash forward to Aisle 1 of your local grocery store. By now this lettuce has been inspected, washed, shrink-wrapped, labeled, UPC-ed, shipped, received and shelved. With each new set of hands it has passed through—both human and mechanical—it has likely experienced an ascending economic stratum with advancing technological features at each step. Sophistication and automation often increase exponentially as the number of places on the continuum increases. A head of lettuce purchased at your local farmers market, for instance, may have only changed hands once or not at all, while a vacuum-sealed carton of greens at your regional mega-outlet has likely seen many locales as well as top-of-the-line technology and automation.

In addition to a variety of technologies, it is likely that this head of lettuce has also passed through the hands of people speaking multiple languages. The laborers at the beginning of the continuum are often non-native English speakers. And regardless of a laborer’s native tongue, lower rates of literacy are common in entry level food industry jobs. According to statistics published by the Department of Labor in 2018, 77% of U.S. farmworkers report Spanish as their primary language. And the same report states that the average level of formal education completed was eighth grade.[5] Therefore, compliance across the continuum must be translatable and comprehendible to all levels of experience and available in all languages of users.

The challenge of complete supply chain compliance from one end of the spectrum to the other warrants cooperation across many lines: state, national, linguistic, cultural and economic to name a few. The need for intuitive solutions and an easy to implement process is paramount.

Technology as the Traceability Solution

With a better understanding of the global food supply chain itself, it is not hard to see why solutions can be found in the tech sector. When the food supply chain existed primarily in a local economy, keeping paper records was a viable process. Now the food supply chain is a global enterprise, and as such, processes must also operate on a global scale.

Tech solutions offer ready-made customization. Language translations, infographics, flowcharts and videos are easily incorporated into platforms for ease of use across all segments of the supply chain. This is beneficial to both domestic and international operations, and it is especially advantageous to those whose operations span both.

The availability of cloud-based platforms has elevated technological capabilities. No longer does every physical operation need its own dedicated server; rather, information is stored and remains accessible anywhere—from a single lettuce field all the way to the grocery store aisle across the world.

“It used to be common that shipments would arrive without necessary paperwork such as invoices, bills of lading or certificates of analysis. Even shipping labels would commonly be ripped off or illegible,” says Geoff Ellis, COO of Wherefour. “Things get lost in the mail. But when all pertinent information is stored in the cloud, it’s unquestionably accessible to the receiver, the shipper and the transport company.”

Not only does the use of cloud-based technology streamline operations for shipping and receiving, but it does the work ahead of time for quality assurance and regulatory compliance. Documentation does not have to be intentionally gathered and prepared for audits. Everything is already in order when a cloud-based tech platform is employed.

The FSMA’s Traceability Plan guide[6] mandates specific controls and standards for record keeping, all of which are reliant on lot codes. Lot code traceability is easily achievable with a comprehensive software solution. And data sharing is significantly improved with a cloud-based system. All involved parties can be in separate parts of one building or in different parts of the world, and they can still be on the same page operationally.

Expertise in the Tech Sector

With the FDA’s commitment to increased traceability, a shift in focus from response to prevention is apparent. And tech solutions have the unique ability to measure efficacy in procedural implementation across the supply chain continuum. Records are created, stored and shared in perpetuity, and those records can be instantly accessed from any location. Leaders in the tech industry are interested in creating solutions that are scalable and transferable. It is not uncommon for a platform whose original design was to address problems in one industry to end up solving a problem in a different industry altogether. Software solutions are by nature about operational functionality and can be applied to any operation therein.

Furthermore, evolution in the tech sector is rapid and collaborative. Expert insights and advancements drive competitors to continually improve and increase productivity and efficiency. “The tech sector is driven by a healthy sense of collaboration and competition,” says Ellis. “It’s exciting to watch the bar being raised by our competitors. It really motivates us to raise it even further with each new feature we develop.”

In order to achieve FSMA compliance within the diverse global food supply chain, implementing low- or no-cost tech-enabled traceability solutions is essential. It is in everyone’s best interest to remove any barriers that would otherwise prevent viable and nutritious food from getting to market.

References

[1] Scallan, E., Hoekstra, R. M., Angulo, F. J., Tauxe, R. V., Widdowson, M., Roy, S. L….Griffin, P. M. (2011). Foodborne Illness Acquired in the United States—Major Pathogens. Emerging Infectious Diseases, 17(1), 7-15. https://doi.org/10.3201/eid1701.p11101

[2] Bratager, Sarah…Grantham, Alison. (2023, May 17). IFT’s Tech-Enabled Traceability Insights Based on the FDA’s Low- or No-Cost Traceability Challenge Submissions. Retrieved from https://www.ift.org/-/media/gftc/pdfs/ift-tech-insights-fda-nolowcost-traceability-report-2023.pdf

[3] FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. (2023, June 26). Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

[4] Food Traceability List. (2023, June 26). Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

[5] Hernandez, Trish and Gabbard, Susan. (2018, January). Findings from the National Agricultural Workers Survey (NAWS) 2015-2016: A Demographic and Employment Profile of United State Farmworkers. 10-14. Retrieved from https://www.dol.gov/sites/dolgov/files/ETA/naws/pdfs/NAWS_Research_Report_13.pdf

[6] Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry. Small Entity Compliance Guide. (2023, May). Retrieved from https://www.fda.gov/media/168142/download