The FDA's ﬁnal rule on traceability – the Food Safety Modernization Act Section 204(d) or FSMA 204 – has changed the records management requirements of every shipment and delivery for every food store, restaurant, foodservice company, restaurant and distribution company in the country.
Passed into law in November 2022, FSMA 204 is part of the FDA's broader New Era of Smarter Food Safety Blueprint, a forward-focused initiative whose primary pillar is "tech-enabled traceability.” Companies that manufacture, process, pack or hold foods on the Food Traceability List (FTL), are now required to capture and exchange numerous data points called Key Data Elements (KDEs), for each Critical Tracking Event (CTE) in a product's journey from its point of origin to the end consumer.
For an average 15-store retailer receiving three deliveries per week with 50 SKUs per load, that equals 117,000 records in one year. FDA requires that data to be stored for two years and retrieved within 24 hours upon request – an impossible task without the right technology.
The FDA has stated that the initial list covered by Section 204 is only the starting point further to improve the safety of the food supply chain. It will take time for your company to adopt new technology and change processes to fully implement end-to-end traceability. ReposiTrak is here to help NGA members to make the switch.
What is a Traceability Lot Code or TLC?
The Traceability Lot Code is an alphanumeric descriptor used to identify a traceability lot or batch of product that is covered on the FTL. The TLC is assigned at a "source” CTE early in the product's lifecycle such as the initial packing, ﬁrst land-based receiving or transforming CTEs. TLCs provide the FDA with access to the location description and source information. As the product changes hands or changes form, the TLC is used to link KDEs together.
What is a KDE and where does it come from?
KDEs or Key Data Elements are speciﬁc types of information required by the FDA to accompany shipments, deliveries or transformation events of products on the FTL. The FDA has deﬁned a speciﬁc set of KDEs for each CTE.
Common KDEs from various CTEs include:
- Traceability Lot Code
- Commodity and, if applicable, variety of the food received
- Quantity and unit of measure of the food received and date of receipt
- Location description for the farm where the food was harvested/cooled/transformed
- Date of harvesting
- Reference document type or number
- Product description for new or transformed food
- Date of shipment
- Date of receipt
- Location description for the immediate subsequent recipient (other than a transporter) of the food
KDEs are often spread across multiple documents and electronic systems used for ordering, shipping and receiving. For example, an ASN might contain the name and address of a supplier, but the lot code might only appear on an invoice or packing slip. The ReposiTrak Traceability Network synchronizes KDEs from multiple documents or systems into the readable format the FDA needs.
What are CTEs?
CTEs or Critical Tracking Events refer to the nodes of the food supply chain where food changes hands or changes form. The CTEs outlined in FSMA 204 include: harvesting, cooling, initial packing of raw agricultural commodities, ﬁrst land-based receiving, transforming, receiving and shipping
When is the compliance deadline for FSMA 204?
January 20, 2026.
What is the ReposiTrak Traceability Network®?
The requirements outlined in the FSMA 204 rule are changing the way every supplier, food store, wholesaler, manufacturer, restaurant, and distribution, on center in the country, maintains and exchanges food traceability data. Traditional labeling and scanning methods won't work and would put an undue burden on your workforce. In addition, it would be physically impossible to ﬁnd the space in your warehouses, distribution centers or store-level backrooms to separate cases and pallets containing FTL foods.
The ReposiTrak Traceability Network is the only scalable solution that works without additional labeling and scanning steps and without the need for new hardware or software. It's free for retailers and wholesalers. For suppliers, there is one low, ﬂat, per-facility fee that allows the exchange of traceability data with an unlimited number of customers.
The ReposiTrak Traceability Network meets and exceeds FSMA 204 requirements and opens the door to a safer food supply chain, better operational transparency and faster, more precise recalls.
FSMA 204: What It Is and What You Can Do to Be Compliant
ReposiTrak’s Derek Hannum joined the government relations and food safety teams from the National Grocers Association to talk about compliance with the new traceability requirements and solutions for simplifying that task.
Watch the Webinar: Traceability 2022 – FSMA 204 What the Industry Needs to Know
Jennifer Crandall, founder and CEO of Safe Food En Route, joined Paul Damaren, executive partner at ReposiTrak days after the final rule on FSMA 204 was published, to discuss the impact of the new regulation on food manufacturers, processors, retailers, wholesalers, foodservice and other companies.
Watch the webinar: What Independents Must Know About FSMA 204
Food safety and transparency are paramount in the grocery industry. To that end, Section 204 of the FDA’s Food Safety and Modernization Act, requiring retailers and wholesalers to comply with traceability procedures, will soon take effect.
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FDA Resources: Food Safety Modernization Act Section 204(d)
Read about the food traceability regulation, which Critical Tracking Events and Key Data Elements apply to you, what’s on the Food Traceability List, and more – directly from the source.