Understanding the FDA’s New Food Traceability Final Rule
The FDA’s Food Traceability Final Rule is a step forward to enhance food safety, quicken recall times, and safeguard public health. This new rule will be highly effective in promoting these goals.
The Food Traceability Final Rule is a step forward to:
· Enhance food safety
· Quicken recall times
· Safeguard public health
This new rule will be highly effective in promoting these goals. Yet, it can also do so much more. If monitored and tracked effectively, you can:
· Make decisions regarding potential quality much quicker
· Rapidly address and reduce quality related credits
· Gain insightful / valuable cost saving intelligence because of real time visibility
· More efficiently manage your business
Are you aware of the details related to the food items handled by your business? In case of a food recall, could you produce accurate records that show each step where the food was grown, harvested, processed/transformed, delivered, received and used? If the FDA required you to generate detailed information, how long would it take you to do so?
A full register of data is essential when a foodborne sickness breaks out, so the source of contamination can be identified quickly and all affected products can be tracked throughout the distribution process. This helps speed up the removal of those products from circulation. To ensure availability of such traceback data for “high-risk” foods, the US Food and Drug Administration (FDA) published the “Requirements for Additional Traceability Records for Certain Foods” (Final Rule) in November 2022. This is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
The FDA's Final Rule requires food establishments to maintain extra records to ensure easier and more efficient traceability for the purposes of investigation or recall. This arrangement allows companies to accurately handle products across their supply chain. The FDA’s Food Traceability List (FTL) outlines specific foods that must adhere to certain requirements. These include soft cheeses, cut/fresh produce, shell eggs, nut butters, seafood & ready-to-eat deli salads. Foods not on the list are exempt from the requirements, for now!
The Final Rule mandates that companies involved in manufacturing, packing, processing, or handling FTL foods need to keep documentation on selected CTEs within the food's supply chain. This includes preserving Key Data Elements (KDEs) as needed. Depending on what type of supply chain a business engages in, the info required can vary from harvesting to processing and distribution to retail. It covers the entire gamut of activities associated with getting goods from their origin to the end user. This framework serves as a strong basis for effective and efficient tracing and provides FDA with the necessary data to carry it out effectively and quickly identify the source of contamination.
The FDA has mandated that all supply chain partners must keep their data for two years, and provide it to the FDA within 24 hours should an outbreak occur. This compliance deadline is set for January 20th, 2026.
As a result, members of the US food industry are updating their systems and business practices to adhere to the specifications prescribed by the Final Rule. In particular, a number of parties involved in the food supply chain are integrating or examining the advantages of GS1 Standards & solutions:
· Global Trade Item Number® (GTIN®) for unique product identification.
· Global Location Number (GLN) for unique party and location identification.
· Global Data Synchronization Network™ (GDSN®) and Global Data Model (GDM) for consistent and accurate descriptions of products.
· Electronic Data Interchange (EDI) and Electronic Product Code Information Services (EPCIS) for structured data capture and sharing internally and among trading partners.
Over 65 retail grocery and foodservice companies belonging to the GS1 US organization came together to study business processes and understand how they can use standards to comply with the Final Rule. The analysis of their requirements has been undertaken as part of this initiative. Participants included leading manufacturers, distributors, retailers, foodservice operators, solution providers, and industry associations. The result of this effort is summarized in a new guideline published by GS1 US, “Application of GS1 System of Standards to Support FSMA 204.” The guidelines set out the optimal ways of identifying products & locations, describing products in a structured fashion, plus keeping track of the industry-specified occurrences that help with traceability requirements.
Until now, each company’s chain of custody record-keeping requirement has been characterized as “one up, one down,” per the 2002 Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act). The new regulations mandate companies to combine data from other organizations with their own. For a successful exchange, it is crucial for the records to be compatible and effectively categorized. Interoperability will come in handy in this regard. Implementing GS1 Standards makes sure that the same standards are maintained across all different kinds of systems & environments, while also catering to diverse business needs.
Barcodes with embedded supply chain data can simplify the data capture process at every stage of the product journey. The data is easy to share between partners, & travels with the product for better traceability. This helps speed up the supply chain and makes it easier to track products.
Firms dealing with FTL foods need to start communicating with their supply partners already, so they can comprehend existing data-record mechanisms and comprehend each other's capabilities. Doing this now will make sure that all necessary information is attainable when it needs to be.
The paperwork involved can be a real headache and this new traceability rule may appear to add an extra element of complexity to an already complicated workflow. Nonetheless, it's important for accuracy & consistency. Setting up the systems to capture and organize data can be time consuming. However, they will provide faster, easier, and more accurate results when conducting an investigation. Having this data ready to go will make the investigation process much simpler overall. By having a full integration of this process across the supply chain and allowing trading partners to share it, there will be a decrease in the amount of confusion and headaches.
Serious operational efficiencies can be obtained by aggregating end-to-end data! Compliance with the Food Traceability Final Rule, if approached correctly, can lead to a lot of extra benefits. The data generated by end to end traceability allows for greater visibility across the supply chain which can lead to predictive analytics and actionable insights. The compliance date is only 33 months away (as of this writing), and it’ll be here quickly!
To learn more about enabling traceability for food safety by leveraging GS1 Standards, and being future ready, please visit www.NazarSystems.com
Chairman, Nazar Systems