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

Before we dive into our thoughts on the FDA's 30-month extension to the food traceability rule, let's be clear about why this rule exists. While improved recall ability is referenced, we firmly believe this rule is more about helping regulators find the source of outbreaks to prevent more consumers from falling sick or dying and investigating the causes of contamination. It's about historical records—information that exists after the product has moved through the supply chain—and the forensic work to determine where an item consumed weeks ago may have come from.

The 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 optimists in us say the industry will use the extension to do traceability the right way; the realists in us think we'll be hearing about the need for another extension 29 months from now! Many groups asked for more time at the fall 2024 Reagan-Udall Foundation traceability meeting. Only one specified an amount—10 years.

Companies and the associations that represent them assert that the rule focuses more on the process than the outcome, specifically the speed with which investigators can trace food back in the event of an outbreak. There is some truth to this. An initiative (Sunrise 2027) is 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 purchased by consumers at the point of sale, making some parts of the rule requirements a moot point.  When we co-led the traceability pilots in 2011, we never envisioned the available capabilities. Technology, and capabilities will keep changing.

In our work with clients, we've found many peculiarities in the rules that challenge feasibility and practicality, but we've also seen a remarkable lack of understanding within the industry about the problem the rule aims to solve. It's worth noting that the FDA's broad data requests obviate any benefits that stem from better granularity in industry records, as pointed out in a blog from last year.

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; traceability is a tool to get there. The regulatory delay shouldn't slow down industry improvement.