Traceability Rule Delay Will Backfire If Industry Doesn't Step Up

Before we dive into our thoughts on the U.S. Food and Drug Administration’s (FDA) proposed 30-month extension to the Food Traceability Rule, let’s be clear about why this rule exists. While the ability to improve recalls is referenced, we strongly believe this rule is more about helping regulators find the source of outbreaks to prevent more consumers from falling sick or dying and investigate the causes of contamination.

As regulators (and consumers!), it must be frustrating not to know where the contamination is occurring while people are falling sick during an ongoing outbreak. And we’ve seen the consequences when regulators can’t trace back fast enough: broad advisories, like “Don’t eat romaine.” This rule is about historical records—information that exists after the product has moved through the supply chain, and the work needed to reconstruct where an item consumed days or weeks ago may have come from.

Industry should view the extra 30 months to comply with the rule as an opportunity to demonstrate creative and effective solutions to help regulators find the source of an outbreak—not just kick the compliance can down the road. The optimist in us says the industry will use the extension to do traceability the right way; the realist in us says we’ll be hearing about the need for another extension 29 months from now.

At the October 2024 Reagan-Udall Foundation traceability meeting, many groups asked for more time (Reagan-Udall 2024). Only one specified an amount: 10 years. It’s been 15 years since the Food Safety Modernization Act was enacted. If it does take another 10 years for the industry to enable enhanced traceability, it will be a quarter of a century to enact a rule Congress wanted in two years!

Companies and the associations that represent them assert that the rule focuses more on the process than the outcome (i.e., the speed and accuracy with which investigators can trace a food back to source in the event of an outbreak). There is some truth to this. Technology and innovation are constantly changing the art of the possible. For example, there’s an initiative called Sunrise 2027 that aims to change the current UPC codes on products to more data-rich barcodes. Once that happens (still years away!), retailers could capture the lot numbers on products purchased by consumers at point of sale, making some rule requirements a moot point. When we co-led the traceability pilots in 2011, we never envisioned the capabilities available today. But this should not be used as an excuse to wait for a silver bullet. Consumers are at risk today; we need to act now to do everything possible to protect them. Let’s not let perfection be the enemy of good.

In our work with clients, we’ve found many peculiarities in the rule that challenge feasibility and practicality. But we’ve also seen a lack of understanding within the industry about the problem the rule aims to solve. It’s worth noting that FDA’s broad data requests obviate any benefits that stem from better granularity in industry records (Food Safety Strategy Blog 2024). This is a systems problem that can only be solved with systems thinking. The capabilities of the industry need to change and evolve alongside the capabilities of the regulators.

We disagree with the notion that traceability is simply reactive. If we think about the goal—finding the source of an outbreak—we can identify what may have gone wrong and put measures in place (across the industry) to avoid recurrence. The focus should be on prevention, and traceability is a tool to get there. Many in the industry have already indicated their desire to continue down the path of enabling enhanced traceability now, regardless of the 30-month extension. Our appeal is to those waiting by the sidelines. Your time to step up is now!ft

The opinions expressed in Dialogue are those of the authors.