Each year in the United States, approximately 48 million people are affected by foodborne illnesses, resulting in some 128,000 hospitalizations and 3,000 deaths, according to a report from the U.S. Food and Drug Administration (FDA). These figures form a significant public health burden but are largely preventable with appropriate traceability measures.
With the latest updates to the Food Safety Modernization Act (FSMA 204), FDA aims to dramatically improve food safety in the U.S. by shifting the focus to prevent foodborne illnesses by enhancing data-driven transparency and accountability within the food system.
With the final implementation deadline set for January 20, 2026, organizations have an opportunity to align FSMA 204 compliance with the global industry move to 2D barcodes at the point of sale. By integrating these two initiatives, brands stand to streamline changes and avoid additional interruption while extending the benefits of traceability beyond mere compliance.
FDA Traceability Rule
Section 204 of the FDA Food Safety Modernization Act adds traceability recordkeeping requirements for businesses that manufacture, process, pack, or hold certain high-risk food products.
FSMA 204 affects any business that handles food items covered under the Food Traceability List, including cheeses; fresh, unprocessed eggs; nut butter; fresh fruit and vegetables; fish and shellfish; and ready-to-eat deli salads.
Under the legislation, non-U.S. companies handling products for final consumption in the United States will have to follow the same traceability requirements as companies located in the U.S.
The United States currently imports roughly 15% of its overall food supply, including 32% of its fresh vegetables, 55% of its fresh fruit, and 94% of all seafood consumed yearly, according to FDA.
What Does FSMA 204 Stipulate?
FSMA 204 specifies the need for businesses to maintain and process data relating to critical tracking events (CTEs) that reflect stages within the supply chain most at risk of incurring food safety incidents.
These stages encompass everything from the initial harvesting of raw produce to the point at which a final, consumer-ready product is received for sale, for example, at a grocery store or retailer.
In tracking CTEs, businesses can more readily identify the source of contamination, food safety, or quality issues that may arise during a product’s journey from farm to fork and respond quickly and efficiently when an incident is identified.
Businesses will be mandated to keep records containing key data elements (KDEs) to track CTEs effectively. While the exact information will vary from case to case, traceability lot codes will form the foundation of the proposed requirements, helping to identify foods as they move through the supply chain.
Impacted organizations will need to put systems in place to collect and share data at key points throughout their own supply chains and store records for two years following the sale or distribution of a food item.
All traceability information also must be made accessible to FDA in electronic format, where required, within 24 hours of being requested. Noncompliance can have consequences that range from civil action up to criminal prosecution.
FSMA 204 officially took effect in January 2023. The deadline of January 20, 2026, is designed to allow for thorough preparation and implementation of traceability solutions across the supply chain.
Preparing for Compliance With FSMA 204
Companies can ensure their traceability recordkeeping adheres to FSMA 204 guidelines by collecting all necessary KDEs and capturing the data as part of wider coding and marking efforts.
The first step will be to identify gaps in data capture across the supply chain and work with supply chain partners to record the necessary data. Data recording will require multiple systems to communicate, so companies will need to consider coding and marking systems that allow for interconnectivity with other equipment to systematically track and record data across the supply chain.
The next step will be to ensure the final consumer product can be tied back to the data required by FDA using variable data printing. Companies adding variable data onto products and packaging such as date codes may only need a small change to their current coding and marking setups to include batch and lot information. One suggested way this variable data element can be implemented is through a scannable 2D code such as a QR code powered by GS1.
Aligning Codes
While a scannable code is not a FSMA 204 requirement, it offers significant opportunities to unlock additional benefits facilitated by enhanced traceability. Companies who incorporate FSMA 204 traceability data within a QR code powered by GS1 can align FSMA 204 compliance with the industry move to 2D barcodes at the retail point of sale.
By aligning these two initiatives, companies can avoid the risk of having to make additional changes further down the line. However, the benefits extend far beyond mitigating two sets of technology integrations.
Machine-readable 2D codes are more resilient to damage or degradation through the supply chain than linear barcodes or human-readable text, making it easier for businesses to track products and help protect consumers from the risk of foodborne illnesses, which is a key aim of FSMA 204. Furthermore, by including unique product data within a scannable 2D code, businesses can provide additional information to consumers, including automatic alerts when a code is scanned to advise of any potential food safety incidents or recalls that could make the food unsafe to eat.
Considerations
To maximize the benefits of 2D codes and variable data printing, companies must ensure the selected coding technology can match the speed and throughput of their production lines, with print quality that is high enough to produce scannable, industry-accepted 2D codes. Data accuracy is also crucial.
Businesses should partner with industry-leading coding and marking providers to ensure their coding solutions can satisfy this need and implement code inspection systems to guarantee all 2D codes are correct and scannable at the time of printing.
A trusted variable data solutions provider should be capable of offering a complete, closed-loop code-and-check system and help to seamlessly align FSMA 204 compliance with the global migration to 2D codes.
Adem Kulauzovic is director of automation at Domino Printing Sciences.