FSMA 204: Changes Across the Field

FSMA Section 204 is front of mind for suppliers of commodities listed on the Food and Drug Administration’s (FDA) Food Traceability List. It’s relatively simple for any one of these operations to record any one Key Data Element (KDE) associated with the Critical Tracking Events (CTE) of their operation. However, it’s quite complex to develop the record linkages, data standards, and software integrations to effectively achieve compliance across a supply chain. The challenge magnifies downstream. 

Let’s say a single mid-sized produce packer handles 5 million cases a year. If each case comes with 5 KDEs, and links to multiple CTEs along the supply chain, one supplier could be managing up to 25 million data points a year that may or may not need to be shared with their customers. If a single major retailer has 50,000 suppliers, they could wind up pulling KDEs from a data lake containing more than a trillion records.

At this scale, it’s hard for a major retailer to parse out unique products and vendors that should be exempt from FSMA 204 reporting. 

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To achieve FDA compliance at scale, retailers may take an all-or-nothing approach – but ‘nothing’ isn’t an option. This has caused new rumblings that the Food Traceability List may become obsolete, leading to universal product traceability as an industry standard.
Eric Edmunds
Senior Director of Regulatory Affairs and General Counsel, The Acheson Group

Kroger Takes the Traceability Leap

For years, it’s been common practice for major retailers to introduce their own independent corporate-level requirements for supplier compliance, often in the form of addenda to established standards. As an example, a variety of major food retail industry players including McDonald’s and Costco have developed addenda through their Safe Quality Foods (SQF) program to satisfy their specific food safety needs and requirements. 

Will retailers take the same approach to product traceability?  It seems that at least one major retail group will mandate FSMA 204-equivalent requirements for all vendors, and all commodities. 

Kroger, the United States’ largest supermarket operator by revenue, has begun to take this very step. As a part of their commitment to consumer safety, Kroger will not only collect and record the traceability information for commodities on the FDA’S Food Traceability List, but all food products entering their facilities.

What will Kroger require of all suppliers by June 30, 2025?
  • Must adhere to Kroger’s EDI 856 ASN guideline

  • Must transmit an EDI 856 ASN document for every product shipment to any Kroger facility
  • Must align logistic unit requirements to match Kroger specifications 

  • Must certify palletized barcode labels on products arriving at receiving docks correspond to the EDI 856 ASN data transmission

The EDI 856, commonly referred to as an Advance Shipping Notice (ASN), is a vital electronic transaction utilized by suppliers, distributors, manufacturers and retailers. Its primary function is to notify the recipient about an upcoming shipment. Many prominent retailers mandate the submission of an ASN within a specified timeframe before products reach their distribution centers or stores. For Kroger, this is becoming the key to universal 204 compliance.

What are all these acronyms?
  • EDI: Electronic Data Interchange
    A digital transaction for data
  • ASN: Advanced Shipping Notice
    A document used to notify a recipient of an upcoming shipment
  • 865: The EDI Format for ASNs
    Facilitated by the American National Standards Institute (ANSI)
Kroger Infographic 1

Supply Chain Reactions

Kroger’s blanket approach to product traceability is unlikely to be an anomaly among major retailers. 

What’s next? If we see an effect similar to the widespread adoption of GFSI addenda, then prominent buyers – including distributors, packers, and manufacturers – could follow suit. It would not be surprising for Whole Foods, Costco, or even Walmart to take similar steps, given the size and complexities of their supply chains.

It’s time that all food companies plan to comply with FSMA 204-equivalent standards. 

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The knock-on effect could be massive. If hundreds of thousands of major retail suppliers must implement universal product traceability, they must pass those requirements onto their own suppliers. The scope could ultimately reach most American products.
Eric Edmunds
Senior Director of Regulatory Affairs and General Counsel, The Acheson Group

Addressing the New Paradigm: Connected Supply Chains

With the broad-sweeping impact of Kroger compliance in mind, how should supply chains evolve to maintain market access? 

In recent years, suppliers’ compliance has been checked by renewing certificates annually. A new paradigm is required to build toward a daily interchange of data. Operations need to evolve their procedures and tools to achieve a Connected Supply Chain – a real-time hub for not only all ongoing compliance documentation but also enhanced visibility. 

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Through the use of a Connected Supply Chain solution like Provision, companies up- and downstream can more easily pull records, certificates, and other required documents. This doesn’t only address FSMA 204 and Kroger compliance; it also uncovers the data for better daily decisions in food safety and quality management.
Eric Edmunds
Senior Director of Regulatory Affairs and General Counsel, The Acheson Group
These are the recommended steps to achieve a Connected Supply Chain for product traceability:
  • Design Procedures
    Ensure your plans, tools, and templates will meet retailer and FDA requirements.

    Tip: Elevate your compliance journey with The Acheson Group (TAG) as your trusted liaison between industry pioneers, regulatory bodies, and academia. TAG provides comprehensive services to support you in reviewing, developing, educating, and implementing protocols that meet the stringent requirements of retailers and the FDA

  • Plan for Scalability

    Ensure every ID used for products and locations is globally unique.

    Tip: GS1 standards are used by more than 2 million companies globally.

  • Enable Easy Data Capture

    Get a digital record-keeping platform that streamlines data entry for CTEs.

    Tip: The average Provision client completes its records in 53% less time. 

  • Integrate Your Network

    Combine data from every record-keeping tool into one central view for traceability.

    Tip: Kezzler plugs into Provision, and was a winner of the FDA Traceability Challenge. 

  • Support Supplier Adoption

    Hire configuration, training, and support services to ensure supplier compliance.

    Tip: DNV is partnered with Provision and Kezzler to offer global support services. 

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I’ve got managers and teams reporting to me in literally every time zone. So to have this dashboard, this visibility into what’s going on real time in my facilities, it’s fantastic to see.
Kyle Farmer
Senior FSQA Manager, Local Bounti

What the Future Holds

The impacts of FSMA 204 will undoubtedly be felt across the entire food industry. If major retailers and buyers follow Kroger’s lead, companies must plan beyond the limited scope of the Food Traceability List. 

Prepare for frequent, ongoing exchange of data; ensure the solutions remain simple for operators, yet robust for networks. No one vendor can provide this alone. By leveraging best-in-class solutions such as TAG, GS1, Kezzler, DNV, and Provision, companies can achieve a Connected Supply Chain in advance of enforcement – while improving their risk management at the same time.