The FDA’s food traceability regulation – the Food Safety Modernization Act Section 204d (FSMA 204) – is now the law. It changes the records management requirements for every shipment and delivery for every food store, restaurant, foodservice company, restaurant and distribution company in the country.
Now, those who manufacture, process, pack or hold foods included on the FDA’s Food Traceability List (FTL) must not only maintain but also SHARE specific Key Data Elements (KDEs) with their customers.
The rule is complicated. We get it.
ReposiTrak has been in the business of traceability for more than 20 years. We’ve been following FSMA since its origins in 2011 and have collected some fantastic resources along the way. Now, we’re sharing those resources with you.
Bookmark this page, share it, use it to educate yourself and your organization on the FSMA 204 and what it means specifically for your company.
FSMA 204 Basics
Section 204(d) of the Food Safety Modernization Act (or 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.”
The regulation defines a set of Key Data Elements (KDEs) that food supply chain operators must capture for each Critical Tracking Event (CTE) in a product’s journey from its point of origin to the end consumer.
FSMA 204 defines a set of Key Data Elements (KDEs) that food supply chain operators must capture for each Critical Tracking Event (CTE) in a product’s journey from its point of origin to the end consumer. KDEs are to be created, collected and stored in a format that can be retrieved and sent to the FDA within 24 hours when requested.
Previously, the Bioterrorism Act only required data from one-up and one-back events.
As a product changes hands or changes form, its string of KDEs grows and must be transferred between trading partners, to create full, end-to-end traceability. ReposiTrak estimates that retailers alone will be responsible for thousands – if not millions – of traceability records per year.
Here are some examples of KDE records. Each time a Food Traceability List (FTL) food changes hands or changes form, this information must travel along with it. The information must always be connected to the food or ingredient’s original traceability lot code.
- Shipping KDEs
- Traceability lot code for the food
- Quantity and unit of measure of the food
- Product description for the food
- Location description for the immediate subsequent recipient (other than a transporter) of the food
- Location description for the location from which you shipped the food
- Date you shipped the food
- Location description for the traceability lot code source or the traceability lot code source reference
- Reference document type and reference document number (maintain only)
- Receiving KDEs
- Traceability lot code for the food
- Quantity and unit of measure of the food
- Product description for the food
- Location description for the immediate subsequent recipient (other than a transporter) of the food
- Location description for where the food was received
- Date you received the food
- Location description for the traceability lot code source or the traceability lot code source reference
- Reference document type and reference document number
- Transformation KDEs
- Traceability lot code for the food
- Product description for the food to which the traceability lot code applies
- For each traceability lot used, the quantity and unit of measure of the food used from that lot For the new food created:
- New traceability lot code for the food
- Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference
- Date transformation was completed
- Product description for the food
- Quantity and unit of measure of the food
- Reference document type and reference document number
For FTL ingredients used:
The days of one-up, one-back tracking are behind us. The FMSA 204 regulation now requires the creation, collection and storage of more information than ever before and the long list of Key Data Elements (KDEs) that are required cannot be printed, exchanged or modified with traditional labeling and scanning methods.
Your retailer and wholesaler customers are required to take in more data now as well. This information must be available to them in a format that can be retrieved and organized into a sortable spreadsheet per the FDA requirement within 24 hours’ notice.
Anyone who manufactures, processes, packs or holds foods on the Food Traceability List (FTL) is responsible for creating, collecting and/or sharing KDEs. The FDA has refers to these nodes of the food supply chain “Critical Tracking Events” or “CTEs”.
- Here are the CTEs defined by FSMA 204:
- Harvesting
- Cooling (before initial packing)
- Initial Packing (RAC)
- First Land-Based Receiver
- Shipping
- Receiving
- Transformation
Learn more about each CTE HERE.
The FDA has grouped the FTL into three main product categories: cheese, produce and seafood. The KDEs required for each category do vary, because the CTEs in their supply chains vary. Take a few minutes to watch the video that pertains to your supply chain (each video is under 10 minutes).
For more than 20 years, ReposiTrak has been solving supply chain collaboration challenges that involve tracking products from manufacturer and grower, through warehouses and distribution centers, all the way to the retail store.
Food traceability is a part of our widely deployed and proven supply chain and compliance platform.
Through the thought leadership of leading industry organizations and retailers, we’ve created the ReposiTrak Traceability Network, a solution that is:
- Easy to implement
- Meets and exceeds the FDA’s FSMA 204 guidelines
- The lowest cost with little impact to consumer pricing
All while fully complying with FSMA 204.
The ReposiTrak Traceability Network is backed by the industry and was most recently selected by the National Grocers Association’s as its exclusive traceability solution.
Starting your New Food Traceability Journey
Ready to start your food traceability journey? Please submit the form below and we will be in touch to schedule a call.
If you'd like to learn more and what questions food supply chain operators are asking about FSMA 204 and traceability, watch this 1-hour webinar, hosted by ReposiTrak and The Acheson Group.
Contact ReposiTrak and TAG for Help with Traceability and FSMA 204 Compliance
Led by former FDA Associate Commissioner for Foods Dr. David Acheson, The Acheson Group (TAG) is a leading global food safety and public health consulting team of subject matter experts. Founded in 2013, TAG’s reputation, team, and client base has grown year after year, continuing to add TAG experts – and expertise.
TAG is offering an initial assessment of how the traceability rule may apply to your specific facility or operation and a written summary of the applicable CTEs and KDEs for $500. TAG can also be engaged for further consultation to assist with your approach to complete supply chain compliance and risk management.
The ReposiTrak Traceability Network is backed by the industry as the lowest-cost, easiest-to-adopt food traceability solution. It was developed with involvement from a consortium of industry leaders to meet and exceed FSMA 204 requirements and opens the door to a safer food supply chain, better operational transparency and faster, more precise recalls. There is no need for new hardware or software.