Congress passed a law to help federal agencies investigate outbreaks of foodborne illness – a regulation experts said could have stopped the US’s largest cyclosporiasis outbreak much sooner. The rule has been delayed – for 15 years, including most recently amid lobbying in 2025. It was set to go into effect in January 2026, months before the single-celled parasite sickened more than 24,000 people and killed two in the midwest.
Now, it won’t go into effect until 2028. The regulation requires enhanced record-keeping for high-risk foods – namely, those which have a history of making people sick, such as soft cheese, leafy greens, eggs and peanut butter – “for persons who manufacture, process, pack, or hold foods”. The promise of the traceability rule is to allow the FDA to more quickly and accurately pinpoint where tainted food came from, all the way down to the farm.
However, the rule has raised the hackles of some in the food supply chain, and retailers and food manufacturers have been particularly vocal about their concerns, lobbying reports show. Earlier this month, a group of 11 consumer, public health and labor advocates called on Congress to speed up implementation of the rule in a letter to lawmakers – arguing this summer’s cyclospora outbreak caused a “crisis in consumer confidence”. He is representing more than 400 people sickened in the outbreak, and has publicly said he supports the groups’ letter.
The heart of uncovering the culprit in a foodborne illness outbreak is the “traceback”. Local health departments are the first line of defense – they find out who ate what and where – a restaurant, a bagged salad, a carton of eggs. Then federal agencies, including the FDA, find out where potentially contaminated food came from by following the supply chain back from a restaurant or grocer to distributors, packing operations and farms.
Those could be coming from completely different sources and then are all packaged up.” The current tracking system in the US derives from the Bioterrorism Act of 2003, according to Jennifer McEntire, founder of the food safety consulting firm Food Strategy. In the years following September 11, 2001, and amid the anthrax threats sent to senior US officials in its aftermath, “it was recognized that food was a critical infrastructure, and that FDA had no idea – no authority – to know what food facilities even existed in the United States. And that was a loophole that was closed through the Bioterrorism Act,” said McEntire.
That left the US with its current system, often called, “one up, one back” – meaning a restaurant or retailer needs to document where they bought something, and a distributor or manufacturer needs to know where they sold something. Still, this system left food traceback incredibly difficult. Determining where individual greens came from is hard because, per a group representing US farmers, data related to where the crop originated is often lost at the point where cases from farms are combined into pallets, which are then loaded on to trucks.
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