FDA traceability rule delayed until 2028 as cyclosporiasis outbreak spreads

Retailers and food manufacturers lobbied for enforcement pause through Congress

The FDA’s traceability rule — a regulation designed to let federal investigators more quickly and accurately pinpoint where tainted food came from, all the way down to the farm — will not be enforced until July 2028 under a provision Congress included in the November 2025 appropriations act that ended a 43-day government shutdown.

The rule had been scheduled to take effect in January 2026, months before a cyclosporiasis outbreak sickened more than 24,000 people and killed two across the Midwest, according to food safety attorney Bill Marler. Marler, who is representing more than 400 people sickened in the outbreak, estimated the true case count could approach 30,000, with 95 percent concentrated in 15 states that have Taco Bell and Taylor Farms. The traceability rule “allows product to get off the market faster so less people get sick — all of those things are good for industry, whose product is being besmirched by one entity,” Marler said.

The rule originates from the Food Safety Modernization Act of 2011, passed during the Obama administration. It requires enhanced record-keeping for high-risk foods — those with histories of causing illness, including soft cheese, leafy greens, eggs, and peanut butter — by “persons who manufacture, process, pack, or hold” such foods.

“Congress recognized this issue in 2010 and asked [the Food and Drug Administration] to develop solutions,” said Sara Sorscher, an attorney who specializes in food safety at the Center for Science in the Public Interest, a consumer advocacy group. “We are now 16 years in, and we still don’t have enforcement of this rule that’s meant to deal with exactly this type of situation.”

The current U.S. tracking system, known as “one up, one back,” derives from the Bioterrorism Act of 2003. Under that framework, a restaurant or retailer documents where they bought a product, and a distributor or manufacturer records where they sold it. Local health departments conduct initial interviews with sickened people; federal agencies then attempt to follow the supply chain back from the point of sale to distributors, packing operations, and ultimately farms.

“It’s pretty crazy,” said Jennifer McIntire, founder of the food safety consulting firm Food Strategy, about the lengthy implementation timeline. “I think FDA does a pretty darn good job, but tracebacks are very, very challenging,” added David Lennarz, co-founder of Registrar Corp, a supply chain compliance company. The complexity of modern produce packaging makes traceback particularly difficult, according to Lennarz. “For example, let’s do packaged salad — lettuce and greens,” he said. “Some of the products you can buy are multiple types of greens — you could have radicchio, spinach, you could have lettuce. Those could be coming from completely different sources and then are all packaged up.”

“Since a field of leafy greens can go to multiple restaurants or multiple homes, we want to be able to find any lettuce that is offending and gather it and pull it back as quickly as possible,” said De Ann Davis, vice-president of science for the Western Growers Association, which represents farmers and supports the traceability rule. Davis said farmers have collected data on where cases of their produce go for more than a decade as part of a voluntary initiative called the Produce Traceability Initiative.

The economic consequences of outbreak-associated contamination are already visible. The price of lettuce dropped more than 16 percent in July, according to government inflation data, as consumers avoided the product.

Even as food safety advocates and growers promote traceability, retailers and food manufacturers have lobbied intensively to slow implementation. The Food Industry Association, or FMI, described traceability as “the most complex regulation the food industry has ever faced” in a recent statement. From 2024 to 2025, lobbyists for FMI, Publix Super Markets, the National Retail Federation, and the International Food Service Distributors Association all lobbied on the traceability rule, according to lobbying disclosures.

The National Retail Federation, whose board of directors includes executives from Albertson’s, Walmart, and Target, told lawmakers it was “requesting inclusion of language in FY24 Agriculture Appropriations bill to require FDA to work collaboratively with industry to address concerns with FSMA 204 traceability rule,” and said it was “seeking support” for a bill that would relax food traceability requirements, introduced by a House Republican from Florida, according to lobbying disclosure reports.

In 2024, the Reagan-Udall Foundation for the FDA — a private nonprofit created by Congress during the Bush administration — held a roundtable with food industry representatives. Attendees included Chipotle, Kellogg Company, the convenience store chain Kwik Trip, the National Restaurant Association, the National Grocers Association, and McDonald’s, according to a summary published by the foundation. Industry representatives at the roundtable argued traceability would “potentially require significant increases in labor, equipment, and space, with significant associated costs.”

In March 2025, the FDA announced a 30-month delay in enforcement of the traceability rule. Eight months later, Congress ended the 43-day government shutdown with a budget bill that included a provision prohibiting enforcement of the rule until July 2028.

In a statement, FMI said the food industry “shares FDA’s commitment to strengthening food traceability, protecting public health and assisting with foodborne illness investigations to quickly identify and remove potentially contaminated products from commerce.” FMI added that the rule is “extraordinarily complex and requires unprecedented coordination among growers, manufacturers, distributors, wholesalers, retailers and foodservice operators.” The Guardian also contacted NRF and Publix Super Markets for comment but did not receive responses.

Earlier this month, a group of 11 consumer, public health, and labor advocates sent a letter to Congress calling for speedier implementation, arguing this summer’s cyclospora outbreak caused a “crisis in consumer confidence.” Marler endorsed the letter. “These grown white men who run these organizations are acting like 2-year-olds… They just don’t want to be told what to do,” Marler said.