FSMA 204: FDA Introduces New Tools for Food Traceability Rule Compliance

FSMA 204: FDA Introduces New Tools for Food Traceability Rule Compliance

Under the FDA's FSMA 204 Food Traceability Rule, manufacturers, processors and those who pack or store foods listed on the Food Traceability List (FTL) are mandated to create and preserve records of Key Data Elements (KDEs) for designated Critical Tracking Events (CTEs) throughout a product's progression in the supply chain.

On November 30, the US Food and Drug Administration (FDA) unveiled new resources and Frequently Asked Questions (FAQs) to further educate stakeholders about the Food Traceability Rule under FSMA 204. These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026.

The Food Traceability Rule, a critical aspect of the FDA Food Safety Modernization Act (FSMA) 204, is designed to expedite the detection and rapid removal of potentially hazardous food from the market. This proactive approach aims to reduce the incidence of foodborne illnesses and deaths. Foods that fall under the final rule’s requirements are listed in the Food Traceability List (FTL) and include cheeses, shell eggs, nut butters, fruits, vegetables, finfish and more.

FSMA 204 Updates

  1. A new webpage detailing traceability lot codes, with illustrative examples of Key Data Elements (KDEs) on invoices and bills of lading.
  2. A video that showcases some technological aspects of product tracing systems.
  3. Sample traceability plans.
  4. Newly added FAQs.
  5. Supply chain examples specifically for deli salads.
  6. Guidelines for applying for waivers or exemptions, if applicable.

Related: New Food Traceability Rule Sparks Concerns Among Grocery Trade Groups

These resources are available on the FDA’s traceability webpage, which also features:

  • Supply chain examples for various commodities;
  • Fact sheets and a starter guide for the FTL;
  • Translations of the rule and supporting materials; and
  • Interactive tools explaining Critical Tracking Events (CTEs) and KDEs, and identifying exemptions to the rule.

Notably, routine inspections under FSMA 204’s Food Traceability Rule are set to commence in 2027, providing additional preparation time for covered entities. This delay is intended to facilitate better collaboration and adherence to the traceability requirements.

The rule, a key element of the FDA’s New Era of Smarter Food Safety Blueprint, implements Section 204(d) of the FDA FSMA. Enacted in January 2011, FSMA 204 mandates enhanced recordkeeping for those involved with foods listed on the FTL.

The FDA’s final rule on “Requirements for Additional Traceability Records for Certain Foods” was released in November 2022. It extends recordkeeping obligations beyond current regulations to those who manufacture, process, pack or hold FTL foods.

Under FSMA 204, the rule focuses on entities handling FTL foods to maintain detailed records of KDEs linked to specific CTEs and provide this information to the FDA promptly. This alignment with industry best practices encompasses both domestic and international firms involved in the US food supply chain, from farm to table.

Complying with the Food Traceability Rule

Some retailers are already preparing for the updated FSMA 204 Food Traceability Rule. For example, Associated Grocers of New England, the largest retailer-owned, wholesale grocery distribution center in the state, announced that it will be enhancing its compliance with the FDA’s FSMA 204 food traceability requirements by leveraging the ReposiTrak Traceability Network

The ReposiTrak Traceability Network, renowned as the largest functioning traceability system globally, facilitates the efficient exchange and management of crucial FDA-mandated data among the cooperative’s suppliers, its distribution center and various retail outlets.

The network has significantly expanded its influence, now accounting for almost eight percent of the retail grocery sector. Since the rule’s issuance, the network has seen a surge in membership, including over 3,000 retail stores, 1,100 suppliers and 20 distribution centers. This growing participation reflects a proactive approach by companies across the food supply chain to achieve compliance well before the FDA’s January 2026 deadline.