Traceability: What You Don’t Know Could Hurt You

Here’s what all retailers need to know about the FDA’s Food Traceability Rule.

Traceability: What You Don’t Know Could Hurt You

November 2024   minute read

By Doug Kantor, Margaret Hardin Mannion

In November 2022, the U.S. Food and Drug Administration (FDA) announced a rule on food traceability. If you haven’t heard about it, that isn’t surprising—most people haven’t. That partly has to do with the quiet, behind-the-scenes way that the federal government often works, and partly to do with the fact that the required rule compliance date set by FDA isn’t until January 20, 2026.

Why would the FDA give everyone more than three years to comply with the rule? Therein lies the story of why most haven’t heard of the rule—and why it’s such a problem.

But before we begin to tell it, it helps to know what the rule does. According to the FDA, anyone that makes, processes, packs or holds foods on the agency’s Food Traceability List will need to collect and maintain data about those foods. The list includes foods such as “fresh cut fruits and vegetables, shell eggs and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses and seafood products.” In particular, the data will have to trace the food all the way back through the food supply chain to its origin. The idea is to aid in product recalls and gather the information needed for food safety measures.

However, the level of detail retailers will be required to collect under the rule is staggering. It requires businesses to track foods on the Food Traceability List all the way down to the lot level. That doesn’t mean following it by the truckload or pallet—the FDA wants retailers to know the information on an individual hard-boiled egg that gets chopped and put into a salad. And if asked, the retailer must provide the required data on that hard-boiled egg to the FDA within 24 hours. If you make and sell one salad per week, that might not be a big deal. But in reality, compliance won’t be sustainable for many businesses.

In addition to the dramatic volume of data required on many different food products, the rule simply does not match how food distribution works in the United States today. There are no standards currently in place that would ensure interoperability among traceability systems throughout the country’s food supply chain. Many of these foods come to central distribution hubs on their way to distributors and processors. Information about where each lot of food came from and is then going simply isn’t kept at that level of the distribution chain. The FDA is asking for information that doesn’t exist.

Retailers might read this and say: Manufacturers and wholesalers will handle this, so it’s not my problem. Unfortunately, not only are retailers independently responsible for gathering and keeping data on the foods that they sell, but if they make or “transform” any foods themselves (including something as simple as chopping fruits or vegetables to put in a packaged cup), they’re then treated like a processor and would have heightened record-keeping responsibilities. Oh, and if a retailer operates its own warehouse or central kitchen where these foods are handled and distributed to its store locations, there’s even more data to be collected and maintained. Put simply, retailers won’t be able to escape the FDA’s rigorous and stringent data requirements.

The FDA is asking for information that doesn’t exist.

The difficulties of complying with this rule are so overwhelming that the FDA gave everyone more than three years to become compliant. If you’ve watched government regulators over time, you have a sense of how significant that is. Rules with lead time that long don’t come around very often, which signals that compliance is going to be very difficult.

But even with three years, many experts question whether a majority of the market will be able to comply in time. The FDA itself even seems to recognize this issue and has stated that routine inspections under the rule will not begin until 2027 “to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule.” Additionally, the FDA notes that it plans to take an “educate before and while we regulate” posture as it begins implementing the food traceability requirements.

NACS has been working closely with the grocery industry and others to try to deal with the problems of this rule. NACS supports the Food Traceability Enhancement Act (H.R. 7563), legislation in the House introduced by Reps. Scott Franklin (R-FL), Sanford Bishop (D-GA) and Jimmy Panetta (D-CA). This bill would require FDA to conduct at least nine pilot projects in coordination with retailers and others in the food industry to identify and evaluate the effectiveness and feasibility of food tracking technologies. The compliance date of the traceability rule would be delayed to two years after the nine pilot projects were completed.

Separately, the annual agriculture spending bill in the House of Representatives includes language that would require the FDA to conduct at least four pilot projects on the food traceability rule, document that the rule can be followed and would be effective in achieving “low-cost” food tracing, and then also give two years following the last documented pilot project for businesses to come into compliance with the rule. There are serious doubts as to whether the FDA could make that showing. If it can, then there would likely be technology or rule fixes allowing it to happen.

Unfortunately, no one can rely on the language in the bill until it is law. As of this writing in early September 2024, it still hasn’t been passed. And that means, just in case, that it’s time for retailers to pay attention to the food traceability rule and start figuring out how it applies to your operations and how, if possible, you could get into compliance with it.

NACS puts together food safety resources to help comply with this and other rules. There are also other resources out there (nothing like a crisis to focus consultants’ attention). So, now is the time to get started. NACS will do what it can to delay and change these ill-considered rules. But now that you know, it’s better to get ready today than be sorry later.

Doug Kantor

Doug Kantor

Doug Kantor is NACS general counsel. He can be reached at [email protected].

Margaret Hardin Mannion

Margaret Hardin Mannion

Margaret Hardin Mannion is the NACS manager of government relations. She can be reached at [email protected].

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