Did your ears perk up suddenly on March 20, thinking you heard a huge sigh of relief – but you were the only one around? If so, you weren’t hearing things; there’s no doubt that FDA’s posting of its intent to extend compliance to the FSMA 204 Traceability Rule elicited such sighs from all across the industry – likely enough so that they couldn’t help but be carried along the wind!
In announcing its “intention” to extend the compliance date for the rule by 30 months, the FDA stated it would use appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.
If, upon reading that, your first thought was that you can now relax and pause your 11th-hour push to what was a January 2026 compliance date, thinking anew is worthwhile. As FDA states in its notice, “the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements.” Going beyond the regulation, it allows the industry to use the time to develop an interoperable traceability system that is fully integrated and beneficial rather than a cobbled together, rudimentary patchwork of systems that would likely have been the January 2026 result. Going even further beyond industry benefit, the extension makes the ultimate goal of the rule – to speed up recall and outbreak investigations for public health protection – more realistic.
While this sentiment sounds logical, in reality it is unlikely to make a lot of difference and the probability that industry will create an interoperable system is no more likely in 30 more months than it is today. This is, at least in part, because the rule not only requires a high degree of coordination between members of the food industry, but it also requires that all covered entities be in compliance in order to achieve the full public health benefits. Thus, FDA notes that it had heard concern from even entities who’ve felt they could be in compliance by January 2026 that all their supply chain partners weren’t in the same position, therefore may not provide accurate data. Additionally, the FDA intends to use the extension to work with stakeholders, including by participating in cross-sector dialogue (such as that with the Partnership for Food Traceability) to identify solutions to challenges and provide technical assistance, tools, and other resources to industry.
Whether or not 30 months was the correct timeframe is debatable – and will be open to comment when the proposed rule is published in the Federal Register. But whether you feel it is too long an extension with the continuing increase in micro-related recalls causing severe illnesses and deaths, or still too short a time to develop an industry-wide system, it is what we have been given. Thus, we need to use the time wisely, not only as individual businesses but in coordination with suppliers and cross-industry entities. We need to use the time to design traceability systems that achieve compliance, provide an interoperable and optimized approach to traceability, can be used to gain internal insights about products and supply chains, generate savings through streamlined processes and logistics, and advance public health.
Although a comment period will open for input on the extension timeline, it will be open for only that. FDA has made it clear that the extension “does not amend, nor do we intend to amend, the requirements of the final rule,” thus comments are not being solicited or considered for changes to the rule itself.
All written content in TAG articles, newsletters, and webpages is developed and written by TAG experts, not AI. We focus on the realities and the science to bring you the most current, exacting information possible.
