FSMA 204 Deadline Extended: What Food Manufacturers Need to Know
Food manufacturers and other businesses preparing for new federal food traceability requirements now have more time to get ready. That’s because The FDA’s Food Traceability Rule, established under Section 204 of the Food Safety Modernization Act (FSMA), has been given an extended deadline. Originally scheduled to carry a compliance date of January 20, 2026, the regulations will now take effect on July 20, 2028.
However, for companies throughout the food supply chain, the additional time doesn’t mean traceability should be put on the back burner. Instead, it provides an excellent opportunity to study the new guidelines, evaluate existing systems, coordinate with supply chain partners, and address potential gaps before enforcement begins. Although July 2028 is almost two years away, it will be here before you know it—so here’s everything you need to know to become compliant by the new deadline.
What Is FSMA 204?
While the FSMA’s deadline extension has placed it back in the news cycle, it’s actually 15 years old as of this writing. According to the FDA, it was signed into law by President Barack Obama in January 2011. Its main purpose was to shift federal food-safety policy toward preventing contamination and foodborne illness, rather than responding after contamination occurs.
Section 204 of FSMA is particularly important to SSI Packaging and our clients, because it focuses on food traceability. Most notably, it contains the FDA’s Food Traceability Rule, which establishes additional recordkeeping requirements for businesses that manufacture, process, pack, or hold certain foods included on the agency’s Food Traceability List (FTL). The list includes certain cheeses, shell eggs, nut butters, fresh and fresh-cut produce, seafood, and other foods.
Many consider the FSMA to be a groundbreaking shift in the United States’ approach to food safety. Once implemented, it will make it easier for the FDA and affected businesses to track potentially contaminated food through the supply chain. When potentially affected products can be rapidly identified and removed, organizations can limit exposure and reduce the risk of foodborne illness.
What Does the Food Traceability Rule Require?
The FDA has organized the Food Traceability Rule around two key categories: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). We’ll explain each of these in detail in the sections below.
What are Critical Tracking Events (CTEs)?
Critical Tracking Events are important points in a food’s journey through the supply chain. They include:
- Harvesting: removing a food/crop from where it was grown or raised.
- Cooling: actively reducing the temperature of a raw agricultural commodity after harvest (before initial packing).
- Initial packing: packing a raw agricultural commodity for the first time, with some exceptions.
- Shipping: arranging for a covered food to move from one location to another.
- Receiving: receiving a covered food at a location after transport from another location.
- Transforming: Manufacturing, processing, or otherwise changing a food or its packaging when the resulting food remains on the Food Traceability List.
What are Key Data Elements (KDEs)?
For each Critical Tracking Event, businesses must record and maintain a specific set of Key Data Elements (KDEs). These KDEs capture important details about the event, such as what food was involved, when and where the event occurred, and the food’s Traceability Lot Code (TLC). While the exact requirements vary by CTE, businesses may need to record information such as:
- Traceability Lot Code (TLC): The code used to identify a specific traceability lot of food.
- Product description: Information identifying the food, such as its product name, brand and variety.
- Quantity and unit of measure: The amount of food involved in the event.
- Date: The date the Critical Tracking Event occurred.
- Location information: Information identifying where the food came from, where it went or where the event occurred.
- Traceability Lot Code source: Information identifying the location where the TLC was assigned.
- Reference documents: Relevant records associated with the food or transaction, such as purchase orders or bills of lading.
Together, these requirements are intended to create a clearer record of how covered foods move from one location to another.
How Should I Prepare for FSMA 204?
If you haven’t yet taken any steps towards becoming FSMA compliant, the deadline extension is great news, as it gives you a much longer runway to prepare. With that said, now is not the time to relax! Even for small businesses, implementing an effective traceability system across multiple, diverse stakeholders can present a significant challenge. Coordinating with suppliers, distributors, and other supply chain partners can quickly eat into that seemingly-generous timeline.
Below is a handy checklist to help your business prepare for the July 2028 deadline.
1. Determine whether the regulations apply to your business. Review the FDA’s Food Traceability List (FTL) and applicable exemptions to determine which of your products and operations may fall under the rule.
2. Review your current traceability processes. Identify and document how your business currently collects, stores, and shares information about products as they move through the supply chain. Compare those processes with the CTE and KDE requirements that will apply to your operation.
3. Identify gaps in your traceability data. Determine whether your existing systems capture the required Key Data Elements at each applicable Critical Tracking Event.
4. Prepare to provide traceability data electronically. In certain circumstances, the FDA may require covered businesses to provide an electronic sortable spreadsheet containing relevant traceability information within 24 hours. Make sure your record-keeping system can quickly produce the required data in a usable electronic format.
How Should I Prepare for FSMA 204: Part 2
5. Evaluate your labeling and coding technology. Consider adopting technologies such as 2D bar codes, variable data printing, and RFID tags. These solutions can help make it easier to trace products as they move through the supply chain.
6. Consider adopting GS1 Standards. GS1-standard barcodes and identifiers are not required for FSMA 204 compliance. However, they are another tool that can help businesses capture and share traceability information. If this is your first time hearing about GS1 standards and the Sunrise 2027 initiative, now is a great time to learn more.
7. Coordinate with your supply chain partners. Meet with suppliers, distributors, and key clients to discuss how they plan to capture and exchange traceability information. Establishing consistent communication touchpoints can help make it easier to track products as they move between organizations.
8. Develop or update your traceability plan. The Food Traceability Rule requires businesses to maintain a written traceability plan that explains their traceability procedures. The good news is, there is no required page length, font, or format, as long as it contains the required information.
Don’t wait—start preparing now!
At the time of this writing, July 2028 is 23 months away—just under two years. However, it’s important to remember that food traceability can be complex, requiring coordination between products, packaging, production systems, records, suppliers, customers, and other supply chain partners. So, don’t just wait for the deadline to creep up. Now is the time to start the process of becoming FMSA compliant.
SSI Packaging distribute packaging, shipping, marking and coding solutions to manufacturers all along the east coast. If you’d like help upgrading your marking and coding technology, please give us a call.