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FDA Releases Small Entity Compliance Guide for the Food Traceability Rule

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The FDA has released a Small Entity Compliance Guide for the FSMA Food Traceability Rule. This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule. It offers recommendations—unless specific regulatory or statutory requirements are cited—on how small entities can comply with the new regulations, which were issued in November 2022. The compliance date for recordkeeping requirements is Jan. 20, 2026.

The guidance document covers:

  • Who is subject to the traceability rule
  • Who is exempt
  • What records must be kept, and for how long
  • How to apply for a modification or exemption
  • How to petition the FDA for waivers
  • Consequences of failure to comply

Download the compliance guide here.