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On September 21, 2020, the U.S. FDA proposed a new rule that lays the foundation for end-to-end food traceability for high risk foods. As an enhancement to the Food Safety Modernization Act (FSMA) passed in 2011, the rule will not only create a formal approach to traceability recordkeeping, but it will also create a strong sense of urgency among the entire food community to leverage more digital, tech-enabled traceability systems both in the near term and the future.

While U.S. food industry stakeholders plan for the rule’s expected implementation in 2022 and the subsequent two years that they have to meet the requirements once final, there are several steps that can be taken across the globe to prepare for the larger goal of widespread supply chain digitization as encouraged by the ‘New Era of Smarter Food Safety.’ The reality is that we work within a globally connected supply chain with diverse and unique suppliers spread out on nearly every continent. Leveraging the unique identification already invested in by US food supply stakeholders to support food traceability across all borders, we can better utilize technology, tools and these standards that connect us in real time and align closer to the transparency and trust that consumers crave.

Here are some ways that GS1 US is currently engaging with the food community to understand the new traceability rule and support supply chain digitization.

Understanding Impacted Food Categories

The proposed rule seeks to establish additional traceability record keeping requirements for high-risk foods, which are captured on the FDA’s proposed Food Traceability List (FTL). This includes leafy greens, fresh-cut fruits and vegetables, some types of fish, eggs, nut butters, and more.

While the rule is limited to this scope, it will standardize the data elements firms must establish and maintain, as well as the information they would need to share with the next partner in the supply chain to facilitate rapid and accurate traceability. For many small suppliers, the rule provides a timely opportunity to automate information gathering to support the requirements. The food community believes this to be a worthwhile undertaking to keep the general public safe and eliminate the frustratingly long foodborne illness investigations of recent years. Ultimately, each link in the supply chain must adopt a data-driven mindset for whole-chain traceability to become a reality.

Educating the Industry: Key Data Elements (KDEs) and Critical Tracking Events (CTEs)

At the heart of the proposed rule is a requirement for those who manufacture, process, pack, ship or receive a food on the food traceability list to establish and maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating, and shipping. For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs). Examples of KDEs include the date the product was received, the date the product was shipped, and a product description. All pieces of data are intended to establish critical linkages that will help to facilitate rapid traceback and trace forward investigations during foodborne illness outbreaks and recall events.

While much of the food industry may already be familiar with the foundational GS1 Standards for identification, such as the Global Trade Item Number (GTIN) and the Global Location Number (GLN), as industry prepares for the FSMA traceability rule, there should be greater urgency within organizations to understand how to apply “visibility standards.” For example, Electronic Product Code Information Services (EPCIS) is a GS1 Standard used by various traceability systems to describe the what, when, where, and why of CTEs, from the harvest to the sale of the finished good. It simplifies the capture and description of events and it enables companies to instantly rely on a single version of the truth about supply chain and logistics events. Standards like EPCIS remove barriers that can be caused by disparate entries and proprietary systems.

Implementing Tech-Enabled Traceability

The use of digital technologies, combined with persistent digital and physical product identification in the supply chain, brings many benefits. In the context of food safety, it can greatly reduce the time it takes to identify the origin of a contaminated food tied to a recall or outbreak. The FDA’s strong endorsement of the use of electronic data exchange over more manual methods of sharing supply chain data (PDFs, spreadsheets, paper documents) represents a move appropriately into the 21st century. While the proposed rule contains exemptions and does not require the use of digital technologies outright, it can still serve as a catalyst for more robust and automated systems to enable end-to-end traceability.

Looking ahead to The GFSI Conference 2021: Rethink, Reset, Recharge

At this year’s GFSI Conference, we hope that you will join me for a virtual fireside chat with Rick Buttner, Senior Director of Supply Chain Operations for Subway’s Independent Purchasing Cooperative (IPC), where we will discuss the impact of the FSMA traceability rule on the foodservice supply chain. Rick and I will talk about what IPC has learned about traceability since implementing GS1 Standards and how they collaborate with their wide array of trading partners using technology.

Join us on 23 March from 1:40-2:10pm CET (Central European Time) for a special session.

This post was written and contributed by:

Siobhan O’Bara

Senior Vice President, Community Engagement


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