FDA Publishes Food Traceability Final Rule

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Since the U.S. Food Safety Modernization Act (FSMA) continues to be the gift that keeps on giving, it makes sense that the U.S. Food and Drug Administration (FDA) would publish its Food Traceability Final Rule just ahead of the holiday season.

The rule, stuck in rewrite for years, is a critical piece of the FDA’s “New Era of Smarter Food Safety Blueprint” and implements Section 204(d) of FSMA. Lawmakers drafted the provision to “facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”

Which product(s) will be affected?

The rule covers foods the FDA placed on the Food Traceability List (FTL), which includes:

  • Fresh-cut fruits and vegetables.
  • Shell eggs.
  • Nut butters.
  • Ready-to-eat deli salads.
  • Cheeses.
  • Seafood products.

The Food Traceability Final Rule requires anyone who manufactures, processes, packs, or holds foods on the FTL to maintain and provide supply chain partners key data elements (KDEs) for certain critical tracking events (CTEs) across the supply chain.

How will “key data” be defined?

The data brands must keep and distribute varies on the type of supply chain activities they perform concerning an FTL item, whether it’s harvesting or producing the food through processing, distribution, and receipt at retail or another point of service. Stakeholders must track the assignment, recording, and sharing of traceability lot codes (TLCs) for FTL foods and link those TLCs to other data identifying the foods as they move along the supply chain.

The final rule does, however, provide full and partial exemptions for some entities and foods, according to the FDA, such as certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others.

When does it go into effect?

The final rule covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for U.S. consumption. The compliance date for the new requirements is Jan. 20, 2026.

“This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” FDA’s deputy commissioner for food policy and response Frank Yiannas explained. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for the industry to adopt and leverage more digital, interoperable, and tech-enabled traceability systems both in the near term and the future.”

How can you prepare?

Manufacturers are familiar with freight forwarders, which compels them to leverage their in-house visibility solutions since they already handle shipments. And these freight forwarders suffer under constant margin pressure for their services.

Historically, transportation operators have cornered the market on end-to-end visibility initiatives for inbound and outbound items. But transparency solutions not incorporated into existing transportation management software are usually a logistical headache.

That’s where TraceGains can help. We’ve had years of experience providing lot-by-lot traceability for inbound items. We’re a network, not some aftermarket plug-in solution. As a result, our customers don’t have to fight against constant integration issues plaguing the existing ERP solution.

We’re also helping our customers prepare for increased regulation through education. In 2023, we’ll offer a series of webinars around food traceability, so stay tuned for more details coming soon.