The Nulogy Operating System
module enables food companies to capture, link, and retrieve lot-level traceability records required under FDA's Food Traceability Rule and produce records in response to an FDA request within the required 24-hour timeframe.
The appropriations bill for FY 2026 prohibits FDA from using federal funds to implement FSMA 204 before the delayed July 2028 compliance date. Earlier implementation of the Traceability Rule could have enabled faster, more effective response to the ongoing cyclosporiasis outbreak linked to Taylor Farms lettuce.
A series of tabletop exercises led by FDA and involving food companies across the supply chain revealed industry’s progress and challenges in meeting the requirements of the Food Traceability Rule/FSMA 204.
The agency has released a discussion paper offering context and questions about the lot-level tracking requirements of the Food Traceability Rule to help shape engagements with industry, including a virtual public meeting in June.
The Food Traceability Rule training, offered through the Food Safety Preventive Controls Alliance (FSPCA), provides industry participants with foundational knowledge needed to understand and comply with FSMA 204 requirements.
TrackAssure captures lot-level records as a byproduct of daily operations, automatically generates FSMA 204-compliant documentation, and delivers audit-ready reports on demand.
Registration is now open for the virtual meetings on FSMA 204, which will be jointly hosted with the Partnership for Food Traceability. FDA is interested in hearing stakeholder feedback on lot-level traceability efforts, industry challenges, and potential solutions.
ReposiTrak asserts that this use case provides evidence that large-scale, automated traceability in compliance with FDA’s Food Traceability Rule is both operationally feasible and economically practical.
A report published by the U.S. Government Accountability Office (GAO) assessed FDA’s completion of the Food Safety Modernization Act (FSMA) and identified several areas requiring more work, such as FSMA 204 implementation, certain Produce Safety Rule and Preventive Controls guidances, and required assessments.
