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GS1 US releases resources to help address U.S. FDA requirements

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EWING, N.J., March 13, 2024 /PRNewswire/ — GS1 US has published a new suite of resources to help companies address the requirements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act Traceability Rule (FSMA Rule 204).

The documents are designed to help trading partners understand how they can use GS1 Standards to meet the stringent recordkeeping requirements for “high-risk” foods.

FSMA Rule 204 requires companies that physically handle certain foods across the supply chain to keep and sometimes share additional records that can assist in faster recalls and tracebacks during an investigation of a foodborne illness outbreak. These requirements apply to entities that manufacture, process, pack or hold foods listed in the FDA’s Food Traceability List (FTL).

The Final Rule outlines specific Key Data Elements (KDEs) of Critical Tracking Events (CTEs) that need to be recorded and shared with the FDA within 24 hours upon request and at minimum, through a sortable electronic spreadsheet.

The new resources include the “Retail Grocery and Foodservice Application of GS1 System of Standards to Support FSMA 204” Guideline (updated to version 2.0) which was prepared by the GS1 US FSMA 204 Workgroup industry members to assist the U.S. food industry with implementing GS1 Standards for traceability and specifically to help meet the requirements.

An accompanying document, GS1 US EPCIS Recommendations for FSMA 204 Critical Tracking Events,” shows how the Electronic Product Code Information Services (EPCIS) Standard can be used to capture supply chain events and what information from those events can be used to supplement the needed data for FSMA Rule 204 CTEs and KDEs.

The EPCIS Standard is designed to capture when and where supply chain objects are involved in many different processes, including when they are created and when they are transferred between trading partners and locations.

The third document, GS1 US EDI Implementation Recommendation for FSMA 204 Critical Tracking Events,” supplements the new Guideline by providing direction for implementing the X12 Electronic Data Interchange (EDI) 856 Advance Ship Notice to help meet the Shipping CTE requirements of FSMA Rule 204.

It seeks to increase consistency and ease of implementation by explaining the data elements and codes and providing real-world examples. This document provides guidance on how to incorporate the additional data required by FSMA Rule 204 into existing EDI implementation.

Additionally, a new e-learning course, “How to Apply GS1 Standards for FSMA 204 Requirements,” is now available. The module provides an interactive overview of FSMA Rule 204 requirements and how to utilize the GS1 System of Standards to help meet those requirements.

“Together these new GS1 US resources form a substantial foundation of guidance for companies to follow in implementing GS1 Standards to meet FSMA Rule 204 requirements,” said Melanie Nuce-Hilton, senior vice president, community engagement, GS1 US. “As the January 2026 compliance deadline for the FSMA Rule 204 approaches, taking steps now to digitize data and recordkeeping systems to share information more efficiently will help to create safer and more resilient food supply chains.”

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About GS1 US?
GS1 US® enables companies to power their supply chains to deliver safe, consistent, authentic, and trusted experiences. Best known as a source for UPC barcodes, GS1 is a not-for-profit, global data standards organization that creates a common language for companies to identify, capture, and share trusted data that links their physical and digital supply chains. Millions of businesses around the world power commerce with GS1 Standards. Learn more at