Watch this recorded webinar where host Rick Biros as he welcomes Dr. Ben Miller from The Acheson Group and Eric Marshall from Leavitt Partners on the “It’s Five o’clock Somewhere” webinar. They’ll unpack the FDA’s FSMA 204 Traceability Rule and explore how the groundbreaking Partnership for Food Traceability (PFT) is leading the way in helping companies and regulators prepare for the new rule.
Watch this webinar recording and learn key food safety elements and details of FDA’s final Food Traceability rule and its implications for frozen foods. Panelists will reveal new research findings and never-before-seen audit data, share ongoing global efforts toward scale transitions in the frozen food supply chain, particularly as it relates to sustainability and energy-use, and discuss potential operational impacts in cold storage facilities.
From June 24, 2024 through July 15, 2024, TraceGains conducted an online survey of 483 food
and beverage industry suppliers to better understand supplier readiness and drivers for change and found
most suppliers stuck in the past, unprepared for change with legacy processes despite a
willingness and understanding on the benefits for modernizing.
To quantify the problem, a new report “Old Habits, New Challenges: The Critical Need for
Modernization in Food and Beverage Supply Chains” found nearly half (48%) of all suppliers
commonly rely on legacy approaches to manage communications with F&B buyers.
These legacy approaches hinder efficiency, with more than two-thirds (71%) of respondents
admitting these methods often cause issues such as data entry errors (39%) and
miscommunication (32%), negatively impacting their ability to operate effectively.
As the regulatory landscape becomes more complex, manual processes will be pushed to the
edge. In fact, compliance with regulatory change made the top-3 list of reasons
suppliers want to modernize their software. Requirements such as the U.S. Food Safety
Modernization Act (FSMA) Rule for Traceability (204), set to take effect in January 2026, will
impose stricter traceability requirements for certain food materials. And, in Europe existing
mandates such as the Corporate Sustainability Due Diligence Directive (CSDDD) already
require time-based sustainability reporting, adding further compliance challenges.
Sustainability continues to be a priority for almost all suppliers, with nine in ten (89%) saying it’s
at least somewhat important for new technologies to align with their company’s corporate
sustainability objectives.
Cost, however, remains the largest factor influencing software purchasing decisions, with 77%
of suppliers citing it as their top consideration, followed by ease of implementation (65%) and
customer support (56%).
The FDA’s Food Safety Modernization Act (FSMA) is designed to enhance food safety by establishing and regulating traceability requirements. The act mandates that all parties in the supply chain share critical information to address potential food safety issues. This article discusses FSMA requirements for comprehensive recordkeeping, including defining Critical Tracking Events (CTEs) and Key Data Elements (KDEs). It highlights the crucial role of Electronic Data Interchange (EDI) in meeting compliance and optimizing food traceability. EDI automates data exchange, improves visibility, simplifies compliance, and enables rapid outbreak response. By investing in EDI technology, organizations can establish a strong foundation for complying with FSMA regulations and ensuring food safety.
The Food & Drug Administration’s (FDA) final ruling for the Food Safety Modernization Act has introduced new stringent regulations that organizations who manufacture, process, pack, or hold foods must follow. The final rule mandates that all parties in the supply chain, from suppliers to retailers, share critical information to promptly address potential food safety issues. This ruling underscores the critical role of technology in maintaining compliance and ensuring safety throughout the food supply chain.
The latest FSMA updates require comprehensive recordkeeping for businesses involved in food production and distribution. Companies must now document key data elements (KDEs) tied to critical tracking events (CTEs) in the food supply chain. This includes manufacturing, processing, packing, and distribution activities for foods listed on the Food Traceability List (FTL). Organizations must provide this data to the FDA within a timely manner and in compliance with accepted standards.
Defining Critical Tracking Events (CTEs)
Critical Tracking Events (CTEs) are key checkpoints that mark the movement of food products from their origin to the retailer or consumer. These milestones offer visibility into the product’s journey through the supply chain. CTEs represent significant points in the food supply chain where specific actions occur, such as:
Defining Key Data Elements (KDEs)
The FDA identifies Key Data Elements (KDEs) as crucial details linked to specific CTEs. This information provides essential insights into food products and their journey through the supply chain. KDEs may include:
Record Keeping Requirements
FSMA’s updated guidelines include specific requirements for the format and duration of recordkeeping. These records must also be available within 24 hours of an FDA inquiry and must be preserved for at least two years. The FDA mandates documentation be preserved in its original format and readily searchable electronically. Consequently, your organization must establish protocols for recordkeeping, product identification, and traceability lot code allocation.
Role of Electronic Data Interchange in Food Traceability
Electronic Data Interchange (EDI) is vital for meeting FSMA compliance and recording critical information such as CTEs and KDEs. EDI automates the exchange of traceability data by integrating with and extracting information from enterprise resource planning (ERP) or warehouse management system (WMS) solutions. EDI can ensure accuracy in KDEs to adhere to critical and time sensitive regulations. EDI also reduces potential manual data entry errors and ensures timely data management. Your suppliers and customers will have different levels of technical aptitude so remember; all types of EDI can be leveraged to achieve these outcomes, including traditional X12 EDI, EDIFACT EDI, and TRADACOMS EDI, along with other electronic data like APIs, JSON or XML, Flat Files, Spreadsheets, and web portals.
This technology streamlines the management of lot information, including its reception, translation, and distribution, and even enables direct integration of lot numbers into ERP systems. This integrated approach enables compliance and benefits all supply chain stakeholders by providing critical data for swift responses to any FDA inquiries regarding food traceability and safety.
EDI is crucial for optimizing food traceability within the supply chain by facilitating the accurate and efficient collection of KDEs and CTEs through the following:
Benefits of EDI Technology in Achieving FSMA Compliance
EDI offers several advantages beyond enhancing food traceability. It also positions your organization to proactively adapt to evolving regulatory landscapes. By investing in a modern, scalable EDI platform, you can establish a strong foundation for complying with upcoming FSMA regulations. To meet FSMA requirements, businesses need adaptable processes and procedures supported by technology that seamlessly integrates and automates critical data exchange. EDI integration specifically contributes to FSMA compliance by enabling:
The cornerstone of food traceability under FSMA hinges on accurately identifying and documenting CTEs and KDEs. These regulations mandate electronically accessible and readily searchable records, underscoring the need for automated B2B integration technologies like EDI. EDI systems optimize data collection, minimizing errors and ensure real-time access to critical information. By automating these processes, EDI not only facilitates compliance but also enhances operational efficiency and responsiveness to potential food safety incidents.
The FSMA food traceability rules represent a pivotal advancement in safeguarding the food supply chain. By enforcing meticulous recordkeeping and rapid data retrieval, the regulation empowers authorities to swiftly identify and address food safety risks, protecting public health. Implementing advanced technologies such as EDI is essential for both compliance and operational excellence. These systems automate data sharing, improve transparency, and foster a connected supply chain all leading to improved business partner relationships, increasing revenue, and higher profitability.
As the industry navigates these rigorous standards, embracing technology will not only ensure compliance but also cultivate a more resilient and responsive food system capable of effectively managing food safety challenges.
Supply chain risks have a significant impact on food safety and quality. Maintaining communication, approving new suppliers in times of geopolitical conflict and product shortages, and conforming to the coming FSMA Traceability Final Rule are among the inherent challenges now facing supply chain managers and food safety professionals.
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.
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:
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.
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:
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.
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.
