Kendall Henry

Associate Editor

Loyola University Chicago School of Law, JD 2027

From potato chips to produce, it seems like food recalls are announced every other day. In today’s global supply chain, a single ingredient may move through countless hands, multiple countries, states, and facilities before reaching shelves. This makes it extremely difficult to identify and fix the cause of outbreaks. The Food and Drug Administration (FDA) is taking a step in strengthening food safety oversight with a new rule with the introduction of the  Food Traceability Rule (FTR). The FTR sets forth a recordkeeping requirement for those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) – high-risk foods identified by the FDA. The enactment of the rule marks a necessary proactive shift in compliance in today’s food production industry.

FTR at a glance

The FTR is an expansion of Section 204 of the FDA’s Food Safety Modernization Act (FSMA), which established recordkeeping for public health protection. FSMA laid the foundation by being a solid step towards proactive prevention of food safety problems through inspections, partnerships, certifications, and more. The FTR builds on this foundation by seeking more transparency and accessibility in the handling of high-risk foods. Specifically, it seeks to mitigate food contamination by requiring recordation of food processing from its beginning to the time it hits the shelves or, as one might say, from farm to table.

At its core, the FTR boils down to food handlers, both domestic and foreign, recording and tracing high-risk foods included on the Food Traceability List. As mandated by FSMA, the FDA, in conjunction with the Center for Disease Control and Prevention (CDC), determined high-risk foods by evaluating an array of factors. These factors include, but are not limited to, known safety risks, such as prior history of outbreaks, likelihood of consumption of contaminated food leading to foodborne illness and known severity of foodborne illness. So, what is on the high-risk list? Covered foods such as fresh produce, crustaceans, cheese, and even ready-to-eat deli salads. Moreover, the list also encompasses foods containing these ingredients. Therefore, the FTR requires any processed or compound ingredient foods, so long as the ingredients stay in the form it appears on the list (e.g., fresh, frozen, etc), to be listed.

The rule in practice

Once a Critical Tracking Event (CTE) occurs, a covered entity must assign Key Data Elements (KDEs) in the form of alphanumeric traceability lot codes, descriptions, locations, and more. CTEs include harvesting, cooling, initial packing, first land-based receiver, shipping, receiving, and transformation. In other words, once a covered food is handled in some way, the set traceability information must be recorded to track the food’s journey. Additionally, the entities are used to develop a traceability plan, which is expected to cover internal procedures, compliance assignments, contacts, and locations. All records must be maintained electronically, via true copies, or original papers. This process and plan will ensure there are thorough records readily available in the event of contamination.

As always in compliance, there are exemptions. For example, if an entity does not handle any of the high-risk foods, they are not subject to the regulation. The FTR sets out other exemptions, including smaller producers, restaurants, and even hospitals and nursing homes that have nonprofit food establishments. The specific categories of the exempted entities emphasize the rule’s focus on foods and entities that reach a large population of public consumers for consumption. Exempted entities are still required to adhere to the FDA’s multitude of other regulations.

FTR on your kitchen table, eventually

Food contamination is a known public health threat that can result in foodborne illness, recalls, or fatality. In an estimate report by the Interagency Food Safety Analytics Collaboration (IFSAC), 95% of the collected data from foodborne-linked disease occurred from 2012 to 2022. The uptick of outbreaks in the last decade reveals the urgent need for traceability measures and food oversight compliance at a closer level. The FTR was drafted to meet this need by requiring records to be readily available that can identify the source of contamination and remove it before causing widespread harm.

For consumers, this can provide peace of mind. Additionally, the FTR provides peace of mind for restaurants, stores, and food providers alike. In the growing age of social media and technology, consumers can instantly share incidents of poor food quality. By requiring entities to trace their ingredients before they reach consumers, contaminated food is avoided.

The FTR’s compliance date was January 20, 2026, but the FDA has granted a 30-month extension. Agencies like the United States Government Accountability Office (GAO) urged the FDA to finalize the plan and implement the rule in 2024 to efficiently trace ingredients linked to illness outbreaks. There is no doubt that coming into compliance with the FTR is a huge undertaking for covered entities, but ensuring that high-risk foods can be traced is a vital step for public health, safer food, and consumer confidence.