FAQs - ReposiTrak Traceability Network®

FAQs about FSMA 204

The proposed FDA Food Traceability Rule is the FDA’s first step toward end-to-end traceability. It requires those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).

FSMA 204 was passed into law in November 2022. Companies have until January 20, 2026 to comply. Remember, compliance requires that each node in the supply chain has the required data from the prior node. Because it’s unlikely that retailers will wait until the last minute to see if suppliers can send the right data, time is of the essence.

There are 19 categories on the FTL: 1. Soft Cheeses 2. Shell eggs 3. Nut butters 4. Cucumbers 5. Herbs 6. Leafy greens (fresh) 7. Leafy greens (fresh-cut) 8. Melons 9. Peppers 10. Sprouts 11. Tomatoes 12. Tropical tree fruits 13. Fresh-cut fruits 14. Fresh-cut vegetables 15. Finfish (fresh and frozen) 16. Smoked finfish (refrigerated and frozen) 17. Crustaceans (fresh and frozen) 18. Molluscan shellfish, bivalves (fresh and frozen) 19. Ready-to-eat deli salads (refrigerated). The FTL items are high-risk, but the FDA has made it clear that this is only the beginning. “One can also say it's (The Traceability Rule) foundational in our work to achieve that kind of end-to-end traceability throughout the food system." Frank Yiannas, former FDA Deputy Commissioner for Food Policy

The data required to be captured varies at each event in the supply chain. This data is known as Key Data Elements (KDEs) and it is associated with a Critical Tracking Event (CTE). A CTE is an event in the food supply chain involving growing, receiving, transforming, creating, or shipping of the food on the FTL. As product moves through the supply chain, every node in the supply chain must store 5-8 data elements at each CTE, and then pass the required KDEs on to their customer. For a retailer with 100 stores, that’s 4.1 million CTEs a year!

With the exception of retail establishments with under $250,000 in annual sales, farms that sell directly to consumers and etc., the rule applies to anyone who grows, creates manufactures, processes, packs, or hold foods on the FTL. For more information about exemptions for retail establishments, visit this page on the FDA’s website. The FDA has also developed a set of flowchart questions to help you determine if your company falls under one of the exemption categories.

The data must be secure, accurate and readily available as FSMA 204 requires that companies provide FDA with required data within 24 hours in a sortable spreadsheet if they ask.

Yes. The FDA’s food traceability requirements are unprecedented and will have far-reaching impacts on supply chains across the nation and the globe. 16 categories may not seem like much, but their impact will cascade through the food supply chain and impact thousands of products when FTL items become ingredients in other items. Just think of tomatoes, how many products contain tomatoes? With data accumulating at every CTE, key data points that need to be accurately stored and forwarded down the supply chain will be in the millions or billions. The sheer volume of data that needs to be managed and readily available for the FDA within 24 hours is staggering.

Why wait? Joining the ReposiTrak Traceability Network® now will not only help you prepare for FSMA 204 compliance quickly, easily and at the lowest cost, it will also ensure that you don’t get stuck behind a backlog of companies who wait until the last minute. Our support team at ReposiTrak will help you every step of the way now, but as we get closer to the deadline, you could get stuck in a queue behind others who need support.

Yes, for two reasons. Number one, FDA has already sent a strong signal to indicate more items will be added to the list. FDA quote related to the products not falling under the current FSMA 204 mandate - “would encourage the voluntary adoption of these practices industry-wide”– FDA.gov. Number two, it’s the responsible thing to do. We’ve already seen several successful suits against retailers and food service providers for passing through a product that killed someone. When the proposal becomes a mandate, it seems inevitable that these suits will be more common and more successful when a lack of traceability is not only irresponsible, but unlawful too.

No. Food brokers who negotiate sales of food from producers to wholesalers, retail stores, and others, but never physically possess the food, would not be subject to the rule.

FAQs about The ReposiTrak Traceability Network® (RTN)

For retailers, thousands of suppliers will send traceability data on every unit of affected product. With data accumulating on every shipment, key data points that need to be accurately received, and securely stored will be in the millions or billions. The sheer volume of data that needs to be managed and readily available for the FDA within 24 hours is staggering. How are retailers going to do that?

For the supplierswho have already collected the required data in their system. The challenge is that their system isn’t aligned with their customers’ (retailers and wholesalers). The retailers will never deal with the with inconsistent data formats received from thousands of vendors; they’ll demand every supplier send the data in a unique, specific format. An ASN could be sent via EDI, csv or xml; within each, the data is codified or formatted a certain way. If a supplier has 50 customers, each asking for their SPECIFIC shipping information, from each shipment sent in a particular way; how can they do that?

For some suppliers, they don’t have a system or process to collect and store the data. Collecting the traceability data can be challenging; most likely scattered through the organization on documents like ASNs, product formulations, BOMs and Production orders. Without changing their processes or investing in new technologies, how do they get their arms around their own data?

For wholesalers, not only will they have to take in and store KDE information from their suppliers, but they’ll also be required to exchange that information with their retailer customers. In addition, if retailers have questions about their own traceability solution for products that aren’t delivered by their wholesaler partners (like the hundreds of additional DSD vendors they deal with who also deliver FTL foods), they’ll undoubtedly go to their wholesaler for answers.

It is an existing Network with massive scale: the largest supply chain collaboration network in the world, which already enables full traceability from end-to-end. Our centralized system with a consistent data management format, dramatically simplifies the exchange of data which saves our customers significant time and money translating and managing the exchange of data. Our centralized system also ensures compliance and integrity across the supply chain with the safety and security of off-premise data storage that ensures the data readily available when needed.

We receive the required data from our customers, securely store the data and then forward the required data to their customers, in the exact format they wanted.

Receive Data
Even if the traceability data is on a document (like a BOM or ASN), we’ll scan the documents and automatically pull in the required data. We’ve been using AI and OCR (Optical Character Recognition) technologies for years on our compliance management platform. With our technology, we can collect the required data from any electronic document. No set up required, just let us access the data or documents.

Store Traceability Data
It’s critical that traceability data be safe and secure for both FDA compliance and risk management. Off-site, secure data storage is the best approach. Customers can confidently store data with ReposiTrak or use us as a back-up knowing that ReposiTrak is a financially strong, public company with bank level data security that is both SOC1 and SOC2 compliant.

Forward Traceability Data
With the volume of traceability data and various systems, a simplified data exchange is critical. After receiving a customer’s data, we do the work to internalize, format and forward the required traceability to your customers.

For over 20 years, ReposiTrak has been solving supply chain challenges that involve tracking products from grower all the way to the retail store. With our inventory maintenance, forecasting, ordering, and scan-based-trading platforms we’ve already developed a deep expertise in supply chain collaboration and data interoperability. And with our supplier compliance management solutions which use OCR and AI to extract the information, we can pull traceability data from virtually any electronic document. Can you think of anyone else that comes close to matching our supply chain expertise, compliance technology and massive scale?

With 67,000 users, 110,000 facilities and 300,000 unique data connections, it’s more than likely that anyone joining RTN will already have suppliers or customers in our system, and they’re already sending us data which leads to a fast and easy implementation with instant end-to-end traceability.

For the last 20 years, we’ve invested over $150 million in our supply chain and compliance management platforms. We’ve specialized in helping partners collaborate to drive a more efficient and safe food supply chain. The fact is, most of the traceability functionality was already a part of our supply chain and compliance platforms.

Adoption is easy, and integration is seamless for all supply chain partners in the network since virtually everyone in the supply chain already produces internal or external documents with the relevant traceability information included. It is built to capture and manage data in any form, including invoices, ASNs, PODs, or label and scan data. The network will convert documents from suppliers so your system can read them and capture data. And it will do the same with data and documents you are expected to share with your customers.

For ReposiTrak to receive the data, no new labels or product scanning is REQUIRED. If an organization already scans and labels, ReposiTrak is still a critical part of Traceability Rule 204 because everyone must have a system to store and manage KDE traceability records and produce those in a spreadsheet format on demand by the FDA. In some cases, if the information is sent electronically to RTN, even if the cases are labeled, the receiver will ALREADY have the info, in RTN, and may be able to bypass scanning pallets and cases. RTN can then export the info to the receiver, and they wouldn’t even need to scan. Plus, RTN does all this without the need for new hardware or software to be installed.

Yes, RTN will collect the KDEs from the CTE that you indicate contains the data required by the FDA to be maintained. These KDEs will be used to stitch together an electronic pedigree of the product being moved through the supply chain. When the FDA requests the information regarding an item, the KDEs on that item can be exported and provided to them (anyone, actually) in a sortable spreadsheet. Data and documents will be captured, safely stored, organized and be readily available for you to respond to any FDA inquiry.

Yes, ReposiTrak operates today in over 100 countries.

Suppliers get immediate access and unlimited use, no matter how many customers or products you have or how much you ship for $179 a month. This service is separate from the Compliance Management service for document or item compliance that you may currently be using.

The FDA still requires the receiver to maintain KDEs for foods received from someone who is exempt from the rule. Traceability is more than scanning and segregating product. It involves capturing, managing and making key data elements (KDEs) available to the FDA when they request it, and forwarding it to your customers for every sale. This is a massive data management undertaking that is easily managed by our company with decades of experience doing just that.