FDA Tabletop Exercises Reveal Traceability Challenges Ahead of FSMA 204 Compliance

The U.S. Food and Drug Administration (FDA) released a report summarizing findings from traceability readiness tabletop exercises conducted earlier this year, revealing that while many food companies are collecting the data needed to comply with the Food Traceability Rule (FTR), challenges remain around traceability lot codes, data standardization and quickly retrieving records across multiple systems and supply chain partners.

The report is based on a series of traceability readiness tabletop exercises held with industry between March 9 and April 1. The exercises were designed to help the food industry prepare to comply with the FTR.

The FTR — established under Section 204 of the Food Safety Modernization Act (FSMA) — requires covered entities that manufacture, process, pack or hold foods on the FDA Food Traceability List to maintain additional records that aim to allow FDA to more rapidly and accurately trace food through the supply chain. Companies must comply with the rule by July 20, 2028.

FDA also updated its Frequently Asked Questions to provide clarity on topics related to the rule, including lot code source reference, food traceability plans and intracompany shipments. 

Simulating a Traceability Records Request.

As part of the tabletop exercises, FDA worked with industry participants to simulate an FTR records request from FDA. The exercises tested whether participants could locate traceability records associated with the handling of a specific product during a short, defined date range and provide the information from those records in an electronic sortable spreadsheet within 24 hours, consistent with the requirements of the FTR, said FDA.

“The exercises demonstrated that meaningful progress is being made toward meeting the FTR requirements,” said the FDA’s Human Foods Program in a June 10 release.

Most firms responded within 24 hours, and proactive supply chain coordination — more than any particular technology — drove the strongest results, according to the agency.

The exercises also demonstrated that some challenges remain with certain data elements, said FDA.

Read the full report here.

The agency said it will use the findings of these exercises to inform its ongoing outreach, education and technical assistance efforts. These exercises, coupled with ongoing engagements, will also help inform potential flexibilities regarding lot-level tracking requirements in the FTR, said FDA.

The FDA recently issued a discussion paper on this topic and plans to obtain more stakeholder feedback at a public meeting scheduled for June 15. Feedback also can be submitted to this docket.