Traceability is a very important tool for public health officials when trying to understand where food may have been contaminated. Yet we have learned how difficult it is.
“Traceability readiness is improving, but significant work remains.” Having conducted a series of traceability readiness tabletop exercises in March to help the food industry prepare for the Food Traceability Rule’s July 2028 compliance date, the FDA concluded that meaningful progress is being made toward meeting requirements, but critical gaps remain in information retention and sharing.
The purpose of the exercises was to simulate an FDA records request and determine if participants could locate traceability records for a specific product during a short, defined date range, then provide the information in an electronic, sortable spreadsheet within 24 hours. FDA’s assessment of the submissions of the 15 voluntarily participating companies – representing producers, processors, distributors, retail food, and restaurants – focused on the rule’s requirements for Key Data Element (KDE) availability for each Critical Tracking Event (CTE) performed.
Primary lessons from the exercises included:
- Overall response times were rapid, but the firms that collaborated with their suppliers further accelerated end-to-end supply chain visibility. This was particularly notable where retail food establishments and restaurants (which are required to provide only their own KTEs) voluntarily coordinated with their suppliers to submit the entire supply chain’s data, dramatically reducing the time needed to identify the source.
- It was also shown that supply chain alignment matters more than technology. Participants used a wide range of tools, but the technology was less determinative of success than whether supply chain partners agreed on the data to collect, maintain, and share—and how. For information not already captured in existing records (i.e., the Traceability Lot Code [TLC] and TLC source), participants noted the importance for trading partners to communicate how data will be transmitted (e.g., barcode, paper record, email, etc.). Additionally, when supply chain partners set shared expectations prior to the exercise, KDE availability was stronger than when firms waited on their suppliers for information, with some ultimately leaving spreadsheet fields blank.
- Although the TLC and TLC source were the most challenging KDEs to capture, FDA found the overall readiness encouraging. The TLC was available or sometimes present in 80% of participants’ records, and the TLC source appeared in 73%. However, only 40% of participants’ records captured the proper TLC across each CTE performed, and only 27% captured the complete TLC source for each CTE.
- Firms’ readiness to share TLC and TLC source information was sporadic, as some firms captured and/or shared a TLC but struggled to accurately document the TLC’s source, while others showed the reverse. Thus, the TLC and TLC source represent two separate readiness gaps. Firms should assess their ability to capture every KDE required at each CTE, rather than assuming that one KDE guarantees readiness to maintain the others.
- The initial packers were not always consistent with listing the TLC source as the location where the TLC was assigned, as some assigned the TLC at initial packing but listed a cooling facility as the TLC source. Thus, initial packers should ensure that the location description for the TLC source accurately reflects the physical location where the food was packed.
- Some firms submitted comprehensive records for certain CTEs but were missing data for others. While some of these may have captured the data but neglected to include it in their submissions, better care needs to be taken. For those where the data was not captured at all, firms should work with their internal teams and supply chain partners to close those gaps before the compliance date.
- Only a small number of participants submitted a draft Traceability Plan. Some had not yet begun to draft one, citing a preference to wait until they had finalized technology vendor selections, while others declined to share their plan with FDA in the exercise even though they said they had one.
- Several distributors and suppliers noted that while the rule requirements may be achievable, inconsistent buyer requirements complicate implementation. Buyer requirements can vary by company and often go well beyond FTR requirements, making it necessary for suppliers to build custom solutions for each customer. Greater standardization and harmonization between buyers and suppliers could significantly reduce these challenges.
While the exercises provided some learnings that apply more particularly to specific links in the supply chain, other learnings were more general – such as the value of a Traceability Plan in testing one’s readiness and assessing gaps prior to the compliance date; readiness depending less on a particular technology and more on trading partners aligning on the flow of information; and communication and proactive collaboration enabling significantly faster traceability to the source. Likely the broader industry challenges are even greater than seen in this small study since those volunteering for the study are probably some of the more informed companies with a greater state of readiness for traceability than most.
The FDA also noted that the exercises showed that most participating firms have begun laying the groundwork for traceability readiness and were able to meet the 24-hour response window. However, with the exercises being voluntary, it is likely that those who were less prepared would have been less willing to participate in such an exercise with FDA. Thus, FDA’s use of the findings for outreach, education, and technical assistance will certainly be of value; and it can likely be assumed that anything participants found to be complex will be seen as complex across the industry. But it will also be prudent for FDA to consider the participants as the better prepared, and develop its outreach and education to the full industry accordingly.
Summary: Having conducted a series of traceability readiness tabletop exercises in March, the FDA concluded that meaningful progress is being made, but critical gaps remain in information retention and sharing. The purpose of the exercises was to simulate an FDA records request and determine if participants could locate traceability records for a specific product during a short, defined date range, then provide the information in an electronic sortable spreadsheet within 24 hours. The FDA also noted that the exercises showed that most of the participating firms have begun laying the groundwork for traceability readiness and were able to meet the 24-hour response window, but these firms may or may not be representative of the whole.
