Standardized Data and the Path to FSMA 204 Compliance
October 24, 2023
Standardized data is the bedrock of compliance with FDA’s Food Traceability Rule, FSMA 204, facilitating use of the same language throughout the supply chain. What that means, for example, is that information sent by a grower can be ingested and understood by the shipper, processor, distributor, retailer, and foodservice operator’s systems.
This will allow for faster identification and rapid removal of potentially contaminated food from the market when there is an outbreak or recall. While the benefits are clear, the prospect of learning and adapting this language to your processes may seem daunting given the scope of the global food supply.
However, many of you already follow GS1 standards in your processes, giving you a head start towards FSMA 204 compliance.
What Are GS1 Standards?
The GS1 standards, including use of GTINs, SSCC pallet labels, and GS1-128 barcodes, provide the means to capture many of the KDEs required by FSMA 204. FDA does not require the use of any specific standards to capture, store, and share data, but it’s important to recognize that organizations covered by this rule can leverage GS1 standards to establish interoperable and scalable traceability systems that meet FSMA 204 requirements.
GS1 standards include identification numbers and acronyms most organizations in the fresh food industry are familiar with, such as GTINs – Global Trade Item Numbers, GLNs – Global Location Numbers, and SSCCs-Serial Shipping Container Codes.
iFoodDS works closely with GS1 and is committed to supporting compliance in a way that draws on existing resources.
Ultimately, standardized data will help ensure that all trading partners in the supply chain speak the same language, much as our cell phones work seamlessly, regardless if one uses AT&T, Verizon, or T-Mobile as their service provider.
GS1 is a global, non-profit corporation. Its standards have their origins in a decision the grocery industry made in the 1970s to adopt a UPC barcode to identify products. Today, GS1 is the most widely used system of standards in the world. More than 300,000 businesses in 25 industries are members of GS1 US, including organizations in the apparel, general merchandise, grocery retail, foodservice, and healthcare industries.
For the fresh food industry, these standards have been developed with input from a broad coalition of industry participants, including grocery retailers, foodservice operators, wholesale distributors and their suppliers, as well as industry associations and solution providers.
GS1 Standards and FSMA 204
A crucial point of FSMA 204 is to distinguish affected foods and their locations from unaffected ones during a food safety investigation. The use of GS1 Standards helps to support the process to quickly identify the affected foods so they can be removed with minimal impact on consumers.
The standards actually go beyond the requirements of FSMA 204 but are not themselves requirements. We are bridging that gap with FSMA 204, supporting standards that are backed by law and tested by experience. This puts us one significant step closer to global data standardization.
The Intersection of GS1 and FSMA 204
There is significant overlap between the GS1 standards and the requirements set forth in FSMA 204. In the final rule, the FDA encourages “the use of any tools that will improve a firm’s procedures for traceability and support the maintenance and sharing of the required traceability records.”
The Traceability Lot Code (TLC)
Let’s start with the Traceability Lot Code (TLC). The FDA requires organizations to assign a traceability lot code to foods on the Food Traceability List (FTL) at the time of initial packing, and again during transformation, if applicable. They must also share this traceability code with downstream supply chain partners.
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.” This definition closely aligns with the industry’s widespread use of lot codes, but there’s an important difference. While traditional lot codes are used to uniquely identify lots within an organization, the TLC must uniquely identify lots across the entire food supply chain.
The Global Trade Item Number (GTIN)
The FDA pointed out that some organizations may wish to use globally unique product identifiers (e.g., GS1 GTIN), along with an internal lot code and standard date code, to establish traceability lot codes. The GTIN identifier specifies how the product is packaged (i.e.: multipack, case, pallet), identifies the source company, and provides core data about the item, such as size, color, brand information, etc.). Its widespread use in global retail makes a GS1-based approach to lot coding a practical choice. The GTIN can also be linked to other detailed product data in an organization’s internal system.
While the FDA does not require product identification by a GTIN, it does note that organizations that use the GTIN for unique identification might already be linking to several of the required KDEs, such as elements of the product description. These KDEs may be linked to a GTIN in a database and entities that use this practice would not need to maintain this information separately.
The GS1-128 Barcode
GS1 Standards help organizations capture the required information by encoding the GTIN and batch or lot in a data carrier such as the GS1-128 barcode, which is already widely used in the industry. A GS1-128 barcode contains important information that helps a shipper communicate with the buyer about the contents of a shipment. Other information on the label and in the barcode, including dates and weights, are not required parts of the Traceability Lot Code or Key Data Elements (KDEs) required by FSMA 204.
Sharing Key Data Elements Required by FSMA 204
Organizations can reliably share the required Critical Tracking Events (CTE) and Key Data Elements (KDE) data through GS1 tools, including the GDSN (Global Data Synchronization Network), EDI (Electronic Data Interchange) or EPCIS (Electronic Product Code Information Services). For example, the Shipping CTE can be shared using an EDI document, the ASN-856 Advanced Ship Notice, that has been used in the food industry for many years.
In many ways, the GS1 standards mirror the goals of FSMA 204. As suppliers pack product into cases, they can encode the GTIN and batch/lot into a data carrier. Cases can be packed in different configurations, such as pallets. SSCCs can then be used to identify the pallets throughout the supply chain. This way as they travel, pallets and cases can be scanned. ASNs with all the detailed information can be sent when the product is shipped to the next trading partner. This allows everyone in the chain to know the product’s locations all the way to the restaurant or grocery store.
GS1’s Proven Track Record
GS1 Standards have a track record of efficiencies and cost savings for its members. For example, consider this case study on the Independent Purchasing Cooperative (IPC), which is responsible for the supply chain processes for the more than 43,000 Subway restaurants globally. IPC has saved $1.3 million a year in costs by maximizing truckload capacity based on accurate product data enabled by GS1 Standards.
CKE Restaurants Holdings, Inc., the parent company of the Carl’s Jr. and Hardee’s restaurants, bases its end-to-end traceability initiative on GS1 Standards. The company has benefited by noticeably improving its recall and withdrawal processes. Rather than casting the widest possible net to determine the locations of implicated products, CKE’s traceability system allows for more targeted recalls and withdrawals, minimizing cost and waste.
Robust, reliable, and standardized data can also provide benefits beyond compliance with FSMA 204. Combined with the right technology, insights from the data you are already collecting can be used to improve efficiencies and overall ROI across your organization and supply chain. Technologies like iFoodDS Trace Exchange ™ (with IBM Food Trust™) can help your organization easily capture, and securely store and share required data. Get a complete picture of your supplier network, allowing you to proactively manage and improve compliance, and instantly traceback and forward across your supply chain