Tag Archives: Food Traceability Final Rule

Food Safety Supply Chain Management Virtual Conference

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Although the FSMA 204 compliance date has been extended, there remains global momentum for traceability, with many downstream suppliers still requiring full traceability plans, consumers pushing for transparency, and businesses discovering unexpected benefits – providing cause of businesses to continue their drive to compliance without pause. The extension has provided time to develop and fine tune a robust, industry interoperable program. Join us in the virtual conference where you will learn the best practices of companies well into FSMA 204 compliance, potential pitfalls that you might encounter, how to navigate the complexities of FSMA compliance and finally, how to achieve end-to-end traceability across your supply chain.

Beltway Beat

FDA Intends to Extend Compliance Date for Food Traceability Rule

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) announced on its website that it intends to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.

The FDA remains committed to successful implementation of the full requirements of the final rule, as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Accordingly, the compliance date extension does not amend the requirements of the final rule. Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.

The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance. Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.

The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools, and other resources to assist industry with implementation.

The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.

Navigating Challenges of FSMA 204 Compliance

By Subhash Chaudhary
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The Food Safety Modernization Act (FSMA) Section 204—known as the Food Traceability Final Rule—aims to ensure food safety through enhanced traceability of high-risk foods. By mandating structured tracking and tracing of food products from farm to fork, the rule not only minimizes the risk of contamination but also provides a rapid recall mechanism if needed. With FSMA 204, food manufacturing companies must take a significant step toward enhancing food safety and protecting public health.

This article delves into what the new traceability rule means for food manufacturing companies, the operational challenges involved in complying with FDA’s requirements, and how advanced product traceability solutions can help organizations turn compliance into a competitive advantage.

FSMA 204 Compliance: 3 Key Components.

FSMA 204 requires food companies to implement robust traceability systems focusing on three key components:

  1. Food Traceability List (FTL):
    The FDA’s FTL identifies high-risk foods (e.g., nut butters, leafy greens, fresh-cut produce) that require enhanced recordkeeping. For instance, nut butters must be tracked carefully through the supply chain due to their inclusion in the FTL.
  2. Key Data Elements (KDEs):
    For every step, the FDA mandates the collection of detailed data:

    • Source Details: Information about where the product originated (e.g., the distributor’s business name, address, and facility details).
    • Destination Details: Where the product is being sent (e.g., the chocolate manufacturer’s facility).
    • Product Details: Specifics such as product description, lot numbers, quantities, units of measure, and packaging information.
    • TLC Source Details: In cases where a product is repackaged (e.g. when a distributor repackages nut butter and assigns a new Traceability Lot Code), the original source must be captured.
  3. Critical Tracking Events (CTEs):
    These are specific points in the supply chain where traceability records must be maintained. Examples include:

    • Shipping: For example, when a distributor ships nut butter from its warehouse to a chocolate manufacturer, the shipment date, origin, destination, and unique traceability lot code are recorded.
    • Receiving: Upon arrival, the chocolate manufacturer confirms the product’s integrity, quantity, and the corresponding lot code.
    • Transformation: When the chocolate manufacturer or its co-manufacturing partner transforms the nut butter by incorporating it into chocolate bars, details of the process—such as production dates, ingredients used, and the new lot code—are documented.

This detailed approach ensures that every touchpoint is recorded, enabling rapid identification of the product’s journey if a recall or investigation becomes necessary.

Operational Challenges in FSMA 204 Compliance

Implementing these enhanced traceability systems is not without its challenges.

  • Fragmented Data Sources: Data complexity due to various sources/formats and variable data attributes makes data management, accuracy, and accessibility across different stakeholders a challenge. For example, while a distributor might capture shipment data in one system, the manufacturer could use an entirely separate ERP to receive and transform details. This is where an ERP-agnostic product traceability solution can help enterprises with seamless ingestion and harmonization of data.
  • Data Completeness and Standardization: Without standardized data capture methods, many companies risk having incomplete records. Consider a scenario where different suppliers use varying formats for lot numbers or unit measurements, complicating the integration process.
  • Real-Time Data Visibility: The regulation demands immediate access to traceability data—which is critical during a recall or contamination event. Legacy systems, which rely on manual data entry or batch uploads, may fall short of meeting these time-sensitive requirements.
  • Interoperability Between Systems: Many companies use diverse ERP, WMS, and legacy systems that do not naturally communicate with each other. Integrating these into a single, cohesive traceability framework is a significant hurdle.
  • Supplier and Partner Readiness and alignment: Smaller suppliers or those in less digitized environments (e.g., field operations still using pen-and-paper logs) can slow down the entire compliance process, requiring additional training and technical support.  Formats and protocols to share and receive the KDE data also need to be aligned with partners.
  • Compliance Reporting and Monitoring: Businesses must generate accurate compliance reports and monitor traceability requirements continuously, which can be difficult without an integrated digital solution.

Business Impact and Analysis

Achieving FSMA 204 compliance offers more than just meeting a regulatory requirement—it creates real business value:

  • Enhanced Brand Trust:
    Transparent traceability systems boost consumer confidence. When a company can quickly and accurately trace a product’s journey—from the distributor’s repackaging of nut butter to its final transformation into a chocolate bar—it reassures consumers about the safety and quality of the product.
  • Operational Efficiency:
    Streamlined, digital systems reduce manual entry errors, cut down on time delays, and optimize the recall process, ultimately lowering costs and increasing supply chain efficiency.
  • Risk Mitigation:
    A well-integrated traceability system reduces the risk of prolonged contamination exposure, minimizes financial losses, and helps maintain a company’s reputation by enabling swift action during food safety incidents.

FSMA 204 Compliance Checklist for Your Organization

A brief checklist your organization can use to ensure continued FSMA 204 compliance:

  • Review & Update Your Traceability Plan:
    Confirm that your traceability plan clearly details procedures for recording Critical Tracking Events (CTEs) and Key Data Elements (KDEs) across all stages—from receiving nut butter to its transformation into a finished product. Include updated traceability lot code assignments and designate a clear point of contact for FSMA inquiries.
  • Verify Data Accuracy and Accessibility:
    Ensure that all records (whether electronic or paper) are complete, legible, and easily retrievable within 24 hours upon FDA request. Test your systems through internal audits and mock recalls to confirm data integrity.
  • Align with Supply Chain Partners:
    Engage with co-manufacturers, co-packers, and distributors to confirm that all parties share consistent traceability records. Establish written agreements that outline data sharing and process responsibilities for each Critical Tracking Event (CTE).
  • Invest in Technology & Traceability Solutions:
    Evaluate your current systems to determine which Key Data Elements (KDEs) are already being captured and where they reside. Identify any gaps or modifications needed to meet FSMA 204 requirements. This assessment will help you decide if your existing ERP, inventory, or traceability software needs upgrades or integration with new digital tools. Investing in dedicated traceability solutions ensures that your organization can reliably capture, manage, and share the required data across all Critical Tracking Events, ultimately strengthening your compliance and food safety efforts.
  • Staff Training and Continuous Improvement:
    Regularly train your staff on FSMA 204 requirements and recordkeeping practices. Update standard operating procedures as needed and keep documentation of training sessions to demonstrate compliance readiness.

By following these steps, your organization will be well-positioned to not only meet FSMA 204 requirements but also enhance overall operational efficiency and food safety throughout your supply chain.

Conclusion

FSMA 204 compliance requires a detailed, standardized, and real-time approach to traceability and rigorous record-keeping requirements.

This is where a cloud-based, globally scalable product traceability solution can ensure regulatory compliance in a dynamic landscape, enhance operational efficiency, food safety, and transparency, as well as collaboration among supply chain partners. Moreover, food manufacturing companies can overcome traceability challenges that impede long-term compliance by embracing digital solutions that integrate specific examples and granular data capture—from shipping details to transformation records.

Comprehensive traceability systems are thus essential as they enable food manufacturing companies to reduce the time to track product movement across disconnected supply chains, enhancing visibility and empowering both organizations and consumers to make informed decisions.

Resources:

https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

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.