July 10, 2024

Resources for the FSMA Food Traceability Rule

In September 2020, the Food and Drug Administration (FDA) published “Requirements for Additional Traceability Records for Certain Foods” (the Traceability Rule or FSMA Rule 204), proposing regulations mandating the establishment and sharing of food production-related records to shorten the FDA’s investigations of outbreaks when they occur. By Jan. 20, 2026, all companies that are subject to the rule will be required to have a traceability plan in place, assign traceability lot codes and maintain records of various critical tracking events as defined in the rule. The rule comes with its own terminology that, as defined by the FDA, may or may not currently be used by or familiar to the fresh produce sector. Here’s a list of resources to aid you with the implementation of the rule.

FDA

Main Information

  • Main Webpage – FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods – Here
  • Main Webpage – Frequently Asked Questions (FAQ) – Here
  • Small Entity Compliance Guide – Here
  • FDA Webinar on Traceability Rule – Here

KDEs/ CTEs/ Food Traceability List/ Lot Codes

  • Critical Tracking Events and Key Data Elements at Different Stages – Here
  • Food Traceability List – Here
  • Traceability Lot Code Information – Here
  • Traceability Plan Example for Farms – Here
  • Sortable Spreadsheet with CTE and KDEs – Here

Exemptions

  • Chart Summarizing Exceptions Relevant to Produce Farms – Here
  • Interactive Tool for Exceptions – Here

Examples

  • Supply Chain Example for Sprouts – Here
  • Supply Chain Example for Cucumbers (Video) – Here

Compliance Dates

  • Tuesday, Jan. 20, 2026

Western Growers

  • Webinar: Demystifying FSMA Rule 204: Supply Chain Traceability – Here
  • Western Growers Guidance for Compliance with the FDA Traceability Rule – Members Access Here

Produce Traceability Initiative (PTI)

The Produce Traceability Initiative is a voluntary, industry-wide effort designed to help the industry maximize the effectiveness of current track and trace procedures, while developing a standardized industry approach to enhance the speed and efficiency of traceability systems for the future.

PTI: Produce Traceability initiative – Here

Additional Helpful Resources

  • iFoodDS – Offers resources and services related to FSMA 204 implementation.
  • New Era Partners – Offers resources and services related to the implementation of FSMA 204.
  • iTradeNetwork – Offers resources and services that can help with FSMA 204 Implementation.
  • Provision – Offers resources and services that can help with FSMA 204 Implementation.