• Those who manufacture, process, pack, or hold foods that are on FDA’s Food Traceability List (FTL), including certain cheeses, shell eggs, nut butters, various fresh fruits and vegetables, finfish, crustaceans, mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing non-transformed FTL foods, are subject to further recordkeeping requirements in addition to the traceability requirements that are generally applicable to other foods.  On November 21, 2022, FDA published the FDA Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule), discussed here, which requires these entities to maintain records containing information known as key data elements (KDEs) that are associated with critical tracking events (CTEs) in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.  When requested, these records must be provided to FDA within 24 hours or some reasonable time to which FDA has agreed. 
  • On May 18, 2023, FDA published a Small Entity Compliance Guide (SECG) to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S.  The SECG defines key terms of the Food Traceability Rule and, in addition to providing detailed guidance on how to comply with each part of the rule, offers guidance for determining whether an entity may be exempt from the rule and instructions on petitioning for a modification, waiver, or exemption from various requirements of the rule.  The SECG also notes that violation of any recordkeeping requirement under FSMA section 204, including any Food Traceability Rule violation, is prohibited under the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm, and that articles that appear not to comply with the requirements of the Food Traceability Rule are subject to refusal of admission to the U.S. 
  • The compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule is Tuesday, January 20, 2026.