A Look at the Changing Landscape of FSMA 204 Data Carriers
April 18, 2024
The food industry is in the midst of a data-sharing revolution. Companies are deploying established and emerging data-sharing technologies to both comply with FDA’s Food Traceability Rule and to increase the transparency of their supply chains.
As companies prepare for the January 2026 FSMA 204 compliance enforcement date, they are deciding on the data carriers that store and carry information related to a specific food. GS1, the most widely used set of standards in the world, defines a data carrier as being a means of physically affixing identification keys and other data to a physical object so that the data may be captured without the need for manual data entry.
These companies are often following the guidance of technology working groups made up of buyers and suppliers across the food industry. The prevailing expectation is that one-dimensional (1D) barcodes, managed by GS1, will remain the dominant data carrier in the near term due to the large installed base of printers, scanners, and software.
But there is change on the horizon.
New Data Carrier Technologies
Advanced technologies such as two-dimensional (2D) barcodes, Radio Frequency Identification (RFID), and Internet of Things (IoT) identifiers are in early production use by some of the largest food companies, restaurants, and retailers. Soon, industry working groups will evaluate and consider these technologies. These groups collaborate to establish industry best practices, selecting the most practical solutions for the facilities and farms that drive the global food supply chain.
So, the choice of data carrier is not one that companies will have to make by themselves.
Andrew Kennedy, principal traceability advisor at New Era Partners, explains that the decision to transition from one technology to another is a collaborative process. In the food industry, technology working groups are often grouped by industry segment or commodity. They work together to balance the costs and benefits associated with such a change.
We’d like to look at this evolving landscape, at data carriers available now and those that will usher in the future. First, some background.
The Heart of the Matter: Sharing the Traceability Lot Code
Data sharing may be the two most important words associated with FDA’s Food Traceability Rule, Section 204 of the Food Safety Modernization Act (FSMA). This is the heart of a global mission jointly undertaken by government and industry to protect consumers from foodborne illnesses by establishing end-to-end food traceability.
In pursuit of that goal, companies that manufacture, process, pack or hold foods on the Food Traceability List (FTL) must maintain and share records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs). These records must be accessible to FDA in an electronic sortable spreadsheet during an outbreak investigation, enabling the agency to quickly target the source.
The Traceability Lot Code is perhaps the most crucial data element required by the rule because it ties a food product to each of the events in its supply chain. FDA requires companies to assign a traceability lot code to foods on the FTL.
FDA defines the TLC as ”a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.” The data carrier that the company chooses will carry that information through the supply chain.
There are multiple tools available now for data gathering, such as Advanced Shipping Notices (ASN). Data carriers link to these databases of information, verifying the information received at each CTE and closing any information gaps as the food commodity travels the global supply chain. For example, the Serial Shipping Container Code (SSCC) is delivered by the data carrier, providing a unique number for the delivery that is connected to the data in the ASN. So, the tools to gather data and those to share them work together.
“Today’s traceability technology can better automate and streamline the food chain, while ensuring that companies comply with planning, data-collecting, and reporting requirements, says Frank Yiannas, former FDA deputy commissioner and an iFoodDS board member.
iFoodDS is agnostic about data carriers but we want you to consider the possibilities and know what the future holds as modern technologies expand the sharing of data and types of information compiled.
1D Barcodes
The most common example of how a series of numbers and letters is displayed and made accessible is the 1D barcode containing data that includes the Global Trade Item Number (GTIN), batch or lot number, and harvest or pack date. The GS1-128 standard barcode is a widely used 1D barcode.
These codes are printed on low-cost paper labels and read by fixed scanners, hand-held scanners and barcode reader apps on inexpensive mobile devices. Barcode scanning requires a line of sight to all the codes on the packages being scanned.
The Produce Traceability Initiative and the GS1 US FSMA 204 Working Group currently advise using the GS1-128 barcode to encode the Traceability Lot Code, incorporating both the GTIN and the lot number at the case level. At the pallet level, it is advised to embed a SSCC within a GS1-128 barcode and link it to an electronic message containing the essential shipping data elements mandated by FSMA 204.
Looking to the future, food industry technical working groups and supply chain owners are also exploring new technologies, including 2D barcodes, RFID and IoT digital sensors.
2D Barcodes
Evolving data carriers like 2D barcodes can provide access to much more information and enhanced functionality, but require image-based scanners. While 1D barcodes can contain about 50 characters of information, 2D barcodes can hold thousands of characters of data and can automatically link to websites for more information.
Looking at two kinds of 2D barcodes, the QR (Quick-Response) code is primarily used to automatically guide consumers to a website when scanned using a smartphone. The GS1 Data Matrix is used in distribution and on retail items because it contains the same data structure as the GS1-128 barcode but can house significantly more information in a smaller space, is easier to print, and is more reliable to read.
For example, the GTIN-14, date code, and lot number require 46 alphanumeric characters out of the 48 allowed in a GS1-128 barcode. The GS1 Data Matrix could easily store this information plus a serial number, net weight, and the Global Location Number (GLN) for the facility in which it was produced. The pharmaceutical industry uses this data carrier to meet FDA’s product identification requirements on retail packaging.
An industry initiative called Sunrise 2027 aims to ensure that all retailers have the technology to scan 2D barcodes by 2027. The goal is to provide greater transparency, traceability and authentication in a way that meets supply chain needs and builds consumer trust.
Radio Frequency Identification (RFID)
RFID uses electronic tags, essentially a label with an embedded antenna and chip, that respond to radio waves by transmitting data encoded on the device by the RFID manufacturer or food producer. RFID tags are affixed to products or pallets, enabling strategically positioned fixed readers or mobile handheld readers to capture and share product visibility information in real time.
Since data is transmitted via radio waves, line of sight is not required and many tags may be read simultaneously. For example, with enough fixed readers a retailer may determine inventory levels for an entire warehouse or store in a matter of seconds. The benefit for restaurants and grocery retailers would be to eliminate or minimize the labor required to track foods received – by lot or even unique serial number.
RFID tags usually carry less data than 1D and 2D barcodes, are four or five times more expensive than labels, and require specialized encoding equipment and readers. However, they reduce labor costs significantly.
In response to the Food Traceability Rule, there has been a resurgence of interest in RFID technology. Quick Service Restaurant (QSR) companies like McDonald’s and Chipotle are particularly intrigued by RFID due to their focused product range and streamlined supplier network, which makes RFID adoption more feasible.
IoT
Companies, such as Wiliot, have pioneered Ambient Internet of Things (IoT) tags that can be thought of as RFID tags on steroids. These advanced tags not only incorporate the typical features of RFID tags, but also come with additional capabilities. Specifically, they include a built-in processor for performing computational tasks, a capacitor to store energy and operate even when not directly powered by radio frequency, and sensors for monitoring various environmental factors such as temperature, light, and humidity
These tags, powered by Bluetooth technology, operate at commonly used wavelengths found in devices all around us. They also eliminate the need for manual scanning, require less expensive hardware readers, and facilitate real-time tracking of foods as they move through the supply chain. This allows tracing applications to gather and share valuable information between trading partners.
Produce and Seafood
We’re not just talking about packaged foods. Data carriers play a key role in the delivery of data about produce and seafood.
The Produce Traceability Initiative best practices and the Global Dialogue on Seafood Traceability standards both promote the use of GSI standards for meeting the CTE and KDE data capture requirements.
According to Alex Miller, a former official on the Gulf States Marine Fisheries Commission and director of enterprise accounts and partnerships at iFoodDS, ensuring traceability is crucial for instilling consumer confidence in seafood safety. Alex concurs that QR codes can swiftly provide consumers with the necessary information by simply scanning their phones.
Next steps
You can see that data carriers help fuel the traceability required by FSMA 204. They facilitate the sharing of identifying data crucial in the event of an outbreak and eliminate the need for manual input of that information, increasing efficiency and accuracy.
The benefits of data-carriers clearly extend beyond traceability, but require careful consideration and collaboration with your trading partners, Kennedy notes. As the technology advances, the benefits include tracking inventory levels in real time, reducing waste by ensuring perishables are used before they expire, monitoring temperatures to help ensure food safety, and theft prevention.
As you face the decision about which data carrier works best for your operation, or any other decision related to compliance with FSMA 204, iFoodDS and New Era Partners have resources to help you find the best traceability and technology solutions. For more information, visit iFoodDS’ FSMA Rule 204 Information Hub and explore the resources available from New Era Partners.