More Pilots, Time Needed for Food Traceability Rule Success

As a food scientist with over two decades of experience, and in my current role at FMI, The Food Industry Association, I’ve witnessed a steadfast commitment to delivering safe food to consumers—from the largest international companies to the smallest independently owned store. Upholding food safety is the food  industry’s number one priority. However, for many in the food industry, how we best get there has become a question of concern.

Thirteen months from now, on January 20, 2026, the compliance deadline for the FDA’s Food Traceability Final Rule will be enforced. Aimed at facilitating faster identification and removal of potentially contaminated food and reducing the impact of foodborne illness and death, the rule’s intent is nothing short of admirable. However, its specifics have posed significant operational and logistical hurdles for companies.

The traceability rule marks a shift in approach to food safety. Instead of focusing on preventing contamination, it emphasizes how quickly we respond after a consumer falls ill. This response-based approach requires extensive recordkeeping to identify foods through-out the supply chain and pinpoint the origin of contamination fast—and companies are finding it has created a monumental data burden.

Those who manufacture, process, pack, or hold foods found on the rule’s Food Traceability List are now required to collect, maintain, and share a host of detailed records about them—product identifiers, production dates, locations, shipping details, and more. Known as “key data elements,” these specifics are captured at critical moments along the supply chain to ensure seamless food traceability. One of the biggest challenges is the requirement around traceability lot codes, the alphanumeric descriptors assigned to food items when they are initially packed or transformed, and stay with them as they move through the supply chain. In many instances, this requires tracking food by the case and sometimes even by the individual item. For retailers and distribution centers that handle thousands of items daily, this level of granularity adds dizzying complexity to daily operations.

Further complicating matters is the scale and scope of the traceability list, the roster of high-risk foods requiring additional recordkeeping. When the list was published back in November 2022, many in the food industry were taken aback by the sheer range of products. It includes everything from fresh herbs and nearly all fresh produce to most types of cheese, deli salads, and multiple seafood items. Its expansiveness means the need for extensive operational systems and data management solutions that increase cost and complexity for companies, especially smaller operators.

Given these challenges, companies are asking for some practical adjustments. The rule’s real-world implementation has yet to be fully tested, so it is critical that we conduct new pilot programs that extend to the investigation phase to ensure the data collection works as intended. The FDA’s pilots were last conducted in 2012 by IFT, a decade before the final rule was passed. Much has changed in the industry since then. Additionally, the tight compliance timeline—a little more than three years—is too aggressive for the scope of the regulation. In their efforts to meet mandated traceability requirements, companies have faced high costs in upgrading software and other data management infrastructure, sometimes making quick fixes that have resulted in a patchwork approach. To do this right, the industry needs more time to upgrade systems and ensure they work seamlessly.

In the conversations surrounding all of this, some suggestions have emerged that could make the rule’s rollout better for everyone. They include allowing for a staggered compliance schedule, or “phased implementation”; prioritizing the traceability of specific, high-priority foods before adding others; a public-private partnership with the FDA to help standardize approaches, test new technologies, and facilitate compliance without imposing undue burdens on companies; and easing the traceability lot code requirements. Lastly, it is imperative that the FDA clarify that perfection in compliance is not the goal. Traceability is a complex process, and 100% accuracy 100% of the time is not realistic.

The food industry is not resisting the traceability rule. We are committed to compliance. However, it’s essential that we proceed in a way that makes sense and provides the FDA with information that will be of assistance during the investigation process. With more time and flexibility, the food industry can continue to innovate, enhance food safety systems, and maintain the priority of providing safe products and assisting with foodborne illness investigations—ultimately maintaining the delicate balance of serving consumers without unnecessary operational or supply chain disruptions.ft

The opinions expressed in Dialogue are those of the author.