Food safety stakeholders continue to warn the Food and Drug Administration that much of the supply chain is not ready to implement its traceability rule, with some arguing the deadline should be staggered or pushed back several years.
In the spring, the Reagan-Udall Foundation for the FDA held a series of roundtable discussions with invited stakeholders. These conversations focused on the Food Safety Modernization Act’s Requirements for Additional Traceability Records for Certain Foods, commonly known as the food traceability rule.
Finalized in 2023, the rule requires the farm-to-table supply chain to keep more detailed records. The hope is that this additional information will better help FDA identify and remove potentially contaminated foods from the market.
Manufacturers, producers, retailers, restaurants and all those along the supply chain have until Jan. 20, 2026, to comply with this rule. FDA has said it won’t begin enforcement until the following year.
Stakeholders agree there is low awareness of the rule and specific requirements across the food system, and that several barriers remain to full implementation like technology and costs. During the recent roundtables, industry representatives suggested more time or a staggered compliance schedule was needed, along with additional pilots to ease any issues with implementation.
Groups representing parts of the supply chain have been focused on their own unique challenges complying with the rule. Some said it was illuminating to hear during these roundtables the shared concerns along the supply chain.
“What we're finding is that other groups had the same challenges, working independently from us. So that tells us it's real, that tells us that the industry is really challenged with certain aspects of it because it was identified across multiple sectors of the industry,” said Hilary Thesmar, chief science officer and senior vice president of food safety at the FMI-The Food Industry Association, which represents supermarket chains.
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There was overall consensus that there’s a lot of complexity within the rule and some sectors may require more time to iron out these details, Thesmar said.
There was no unified suggestion on how much longer the supply chain may need. Still, several groups said they hope FDA is open to the idea of pushing back the January 2026 deadline.
With a more complex rule like the traceability regulation, it’s not unheard of that FDA could give enforcement discretion, but the agency has not signaled to stakeholders if that is on the table, Thesmar said.
Stephanie Johnson, vice president of government relations at the National Grocers Association, suggested pushing the deadline back to at least 2030 or at a minimum implementing a staggered approach. She said retailers rely on their suppliers, distributors and the preceding rings of the supply chain.
“We are just nowhere near being able to comply,” Johnson said.
A phased-in compliance schedule that puts retailers and restaurants last would allow for a more “stable, long term process,” Johnson said.
“I'm worried that if we rush the implementation, folks are going to make shortcuts, we're not going to do it right, and it's going to be sloppy, and we're going to be stuck with a lot of the messes that we're making because we are out of time,” Johnson said.
Patrick Guzzle, vice president of food science and industry at the National Restaurant Association, also voiced support for a staggered approach to the compliance timeline. He suggested starting with the “biggest players” before requiring small restaurants or retailers to comply.
The rule includes an exemption for restaurants that sell less than $250,000 worth of food in a year, but NRA estimates about 85% to 86% of restaurants must still comply with the new guidelines.
Foodborne illness outbreaks can be “devastating” to restaurants, so to lessen the burden through this rule is of interest to many NRA members, Guzzle said. However, there are some parts of the rule that present a unique challenge, he said.
Given the complexities and misconceptions about the rule, Guzzle said there’s particular concern about the challenges complying with this rule for restaurant owners who do not speak English as a primary language, or smaller businesses.
FDA has pushed routine inspections and enforcement of the traceability rule until 2027, with the exception of foodborne illness outbreak investigations, Thesmar said. However, this often puts retailers and restaurants who are at the first step of an outbreak investigation. in a difficult spot, if suppliers are not fully collecting and providing the necessary information.
Even if the rule is not enforced until 2027, FDA has made it clear that it has no jurisdiction over restaurants, Guzzle said. This means state and local health departments will likely oversee traceability enforcement. He said this is an additional concern as the compliance deadline approaches.
“January 2026 is a very ambitious deadline,” Guzzle said. “I would love it if they could extend that a little more.”
Stakeholders who participated in the roundtables also generally agreed that more pilots are needed to test the new requirements. Some groups suggested pilots should demonstrate that tracing can be done successfully, and allow time for findings to be shared publicly for the supply chain to implement before the compliance date.
Multiple pilots have been completed, but some of the findings from these tests have not been published, Thesmar said. Additionally, some of these pilots may have focused on one product or one facility, which does not capture all the complexity and requirements laid out in the rule.
“A lot of the pilots that we're hearing about are done privately, they're not sharing out the lessons learned,” said Johnson with NGA. “And I think we need to start failing faster so we can know what doesn't work, so we can try something else and then move on and really get closer to compliance.”
Thesmar said there has also been limited testing on the FDA’s ability to use the new information being gathered to trace back and resolve a foodborne illness.
“We're just hoping that this works, and we need to actually test it and make sure that it works, because of the impact and the expense on the industry.” Thesmar said.
Johnson said it’s important for pilots to include FDA and fully test the ability to track food items from the farm to table and back again. Johnson said she was unaware of anyone conducting a pilot that successfully fulfilled the rule’s purpose and requirement. She also did not know of any pilots specifically in the retail sector.
There are some legislative proposals, like H.R. 7563, the Food Traceability Enhancement Act, that would require FDA to successfully complete pilots as described by Johnson before compliance takes effect. A similar provision was also included in the House Ag Appropriations bill for fiscal 2025.
Food safety advocates oppose the provision, arguing it would unnecessarily delay the rule’s implementation. Additionally, the pilot requirements detailed in the provisions would force the FDA to “develop a cherry-picked example” against the lot code requirement, according to a release by the Center for Science in the Public Interest.
The lot code requirements are crucial to the traceability rule, and allowing retailers to discard this information would “devalue” efforts by producers, distributors, manufacturers and more, CSPI said.
Stakeholders involved in the roundtable discussions agreed that these pilots should not halt implementation, according to the summary from the Reagan-Udall Foundation.
Largely, the food supply chain is asking FDA for more flexibility in the rule rather than outright changes. Groups are largely behind the goal of the traceability requirements and understand the need to boost food safety tracking, but believe small fixes can make the rule more feasible.
For example, FMI and the International Fresh Produce Association have asked FDA for similar flexibilities to ease some of the requirements on traceability lot codes.
Currently, the rule requires every lot code for every case that arrives in a store to be scanned. This comes with additional equipment, labor and training and is open to human error, IFPA has argued. The group has proposed a way of alleviating some of these issues but is waiting on FDA approval.
FMI wants the supply chain to be able to provide a range of lot codes rather than a one-to-one lot code.
Thesmar said it’s difficult to get down to the case or individual item level accurately, and it could slow down the process of getting deliveries out of distribution.
“We think that it's practical and within their authority that FDA …that they give us the more flexible solution on this,” Thesmar said.
In the summary of the roundtable discussions, stakeholders also raised other issues like misconceptions and technology. There’s some concern that people in the supply chain still don’t know they have to comply with this rule, or wrongly believe their system is already in compliance.
Stakeholders are optimistic that FDA is open to some of these suggestions, and were encouraged by the agency’s decision to hold a public meeting in October.
Jim Jones, deputy commissioner of FDA’s Human Foods program.After testifying at a House subcommittee hearing, Jim Jones, deputy commissioner of the FDA’s Human Foods Program, said the agency is waiting until after the public meeting in October to consider all options moving forward, including the compliance timeline.
“I do think that they are taking this seriously, they are listening, and I am hopeful that they will put some changes out by the end of this year, however minor they may end up being,” Johnson said of FDA.
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