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 only problem? 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.
“Congress
recognized this issue in 2010 and asked [the Food and Drug
Administration, or FDA] 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.”
Often
called the “traceability rule”, the regulation comes from the Food
Safety and Modernization Act (FSMA) of 2011, passed during the Obama
administration. 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.
“It’s
pretty crazy,” said Jennifer McIntire, founder of the food safety
consulting firm Food Strategy, about the lengthy implementation of the
rule.
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”.
“It’s probably getting close to
30,000 people – 95% of all the illnesses occur in the 15 states that
have Taco Bell and Taylor Farms,” said Bill Marler, a leading food
safety attorney, about the cyclosporiasis outbreak. 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.
“For
example, let’s do packaged salad – lettuce and greens,” said David
Lennarz, who co-founded Registrar Corp, a supply chain company that
helps businesses comply with federal food safety regulations.
“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.”
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.
“I think FDA does a pretty darn good job, but tracebacks are very, very challenging,” said Lennarz.
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.
“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.
The stakes are high for farmers – the price of lettuce dropped more than 16% in July,
according to government inflation data, as consumers dropped lettuces.
Davis said farmers have collected data on where cases of their produce
goes for more than a decade as part of a voluntary initiative called the
Produce Traceability Initiative.
“If
post-when-we-ship it is not traced well, or tracked well, there is very
little our grower can do about it,” said Davis. The government’s
traceability rule would require manufacturers and sellers to retain that
information, so that it can be provided to the FDA in the case of
contamination.
Even as food safety advocates
and growers promote traceability, some of the most intense lobbying has
come from retailers and food industry groups. The Food Industry
Association (FMI) described traceability as “the most complex regulation
the food industry has ever faced” in a recent statement, and retailers
made their “concerns” about the regulation known to lawmakers and
regulators, lobbying reports show.
In 2024, the Reagan-Udall Foundation
for the FDA, a private nonprofit created by Congress during the
Bush-era, held a roundtable with representatives of the food industry,
from behemoths to influential restaurant groups. Among the attendees
were Chipotle, Kellogg Company, the midwestern convenience store chain
Kwik Trip, the National Restaurant Association, the National Grocers
Association and McDonald’s.
In a summary of
the event published by Reagan-Udall, industry representatives argued
traceability would “potentially require significant increases in labor,
equipment, and space, with significant associated costs”, according to a
2024 industry roundtable with an FDA-affiliated nonprofit.
From
2024 to 2025, lobbyists for FMI, the southern giant Publix Super
Markets, the National Retail Federation and the International Food
Service Distributors Association all lobbied on the traceability rule.
The
National Retail Federation (NRF), whose board of directors includes
food heavyweights such as Albertson’s, Walmart and Target said in
lobbying disclosure reports that it was “requesting inclusion of
language in FY24 Agriculture Appropriations bill to require FDA to work
collaboratively with industry to address concerns with FMSA 204
traceability rule”, and that it was “seeking support” for a bill that
would relax food traceability requirements, introduced by a House
Republican from Florida. NRF also expressed “concerns with FMSA 204
traceability rule” to the House, Senate, FDA and CDC, according to lobbying reports.
After
all this lobbying, the industry got part of what it wanted – another
delay. In March 2025, the FDA announced a 30-month delay in enforcement
of the traceability rule. In November 2025, Congress ended a historic 43-day government shutdown with a budget bill.
Buried in the massive appropriations act was an important provision for food safety: Congress prohibited
enforcement of the traceability rule until July 2028 – the same
provision that consumer groups asked lawmakers to rescind in a letter
this month.
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 and our member companies have
put in a tremendous amount of time, effort and resources over the last
four years to understand and implement the FDA Food Traceability Rule.”
FMI
continued: “It is extraordinarily complex and requires unprecedented
coordination among growers, manufacturers, distributors, wholesalers,
retailers and foodservice operators. Having adequate time is essential
for addressing operational realities and developing practical, workable
solutions across the entire food supply chain without increasing costs
or disrupting the flow of goods. We look forward to continuing to work
with FDA to ensure that the rule reflects the goals of the 2011 Food
Safety Modernization Act and that food companies of all sizes are able
to comply.”
The Guardian also contacted NRF and Publix Super Markets for comment, but did not receive a response.
But
for some advocates like Marler, whose law firm handles cases of victims
who may be severely injured or even killed by food contamination, the
delays are nothing short of inconceivable.
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”, said Marler.
“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.”
