FDA Finalizes New Traceability Rules for High-Risk Foods

After at least eight years in the making, the FDA announced the final rule to improve food traceability for domestic and foreign manufacturers who process, package, or hold foods included on the Food Traceability List (FTL) for U.S. consumption. This rule will require those manufacturers to maintain records containing Key Data Elements (KDE) associated with specific Critical Tracking Events (CTE)-such as harvesting, cooling, initially packing, shipping, receiving, and transforming foods-and provide this information to the FDA within 24 hours, or within a reasonable time agreed upon with the FDA.

Why Did the FDA Implement the New Rule Now?

The CDC estimates that around 47.8 million Americans will domestically acquire foodborne illnesses every year. The final rule will allow faster identification of the origin and travel route of contaminated foods and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses.

“While limited to only certain foods (those on the FTL), this proposal lays the foundation for a standardized approach to traceability recordkeeping, paving the way for the industry to adopt, harmonize, and leverage more digital traceability systems in the future,” the FDA said.

This new regulation standard helps lay the foundation for greater traceability as part of the “New Era of Smarter Food Safety” initiative. This initiative includes four core elements in its blueprint, tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and food safety culture.

How Does the Food Traceability Rule Work?

The FDA will require manufacturers who process, package, or hold foods included in the Food Traceability List to report Key Data Elements associated with Critical Tracking Events to them within 24 hours or a reasonable time agreed upon by the FDA. These reports can be recorded as original paper or electronic records. Still, the FDA will call upon electronic sortable spreadsheets when necessary to assist during outbreaks, recalls, or other threats to public health.

Critical Tracking Events will be required to record KDE, such as a description of where food was harvested, cooled, packaged, received, and shipped; quantity amounts for food harvested, cooled, packaged, received, and shipped; date the food was harvested, cooled, packaged, received, and shipped and many other elements specific to each stage of tracking. For a complete list of KDE associated with CTE, click here.

What This Means for Producers

“Central to the proposed requirements is the assignment, recording, and sharing of traceability lot codes for FTL foods, as well as linking these lot codes to other information identifying the foods as they move through the supply chain,” the final rule said.

Businesses impacted by the final rule will be required to have a Traceability Plan to help regulators understand the extent of the company’s visibility into their supply chain. The FDA states there will be training for manufacturers affected by this new regulation.

“In this interim period, we intend to provide outreach and training, as well as guidance and other materials, to help all sectors of the food industry come into compliance with the new traceability record-keeping requirements applicable to them under the new regulation,” the FDA said.

Failure to comply with the final rule will result in warning letters to notify firms of their violations. With no corrective action taken, the Federal government may bring a civil action in Federal court enjoined with those who committed the prohibited act. Multiple entities may be held responsible for failure to maintain traceability records.

How ERP Software Built for Food Manufacturers Can Help

While investing in technological tools is not required by the FDA, it is “strongly encouraged.” And since they do not plan to develop a software program for those subject to the rules at this time, it can be challenging for manufacturers looking for a quick solution to digitally keep the records the FDA now requires. Food manufacturers need to leverage technology that can inform, track, and trace every ingredient to ensure safety and prevent recalls.

Mistakes are likely to occur when information is manually entered. Since the FDA does not yet have any particular reference document to meet requirements, it is up to those in the supply chain to hold responsibility for illegible or inaccurate documentation. To prevent a scenario in which information is incorrectly passed through the chain, manufacturers need powerful ERP software that can help them quickly identify and label ingredients, brand requirements, and other necessary documentation required to ensure FTL foods are being properly processed. Having strict lot control and hyper traceability throughout the entire formulation process in one centralized solution will help manufacturers report FDA data quicker and help their overall operations run smoother in their everyday processes.