FDA must set limits on PFAS in food, lawsuit says
US regulators are failing to address concerns about toxic PFAS chemicals in foods despite having the scientific tools to do so, according to a lawsuit filed by an environmental group in Tucson, Arizona.
The lawsuit, filed on
Jan. 24 in the US District Court of Arizona, follows the submission of a
legal petition filed
in November 2023 by the Tucson Environmental Justice Task Force that asked the
Food and Drug Administration (FDA) to establish limits for certain per- and
polyfluoroalkyl substances (PFAS) the agency has found in blueberries, lettuce,
milk, salmon and other foods. The group wants the FDA to take action to remove
products from grocery store shelves if PFAS residues are found at the minimum
level of detection.
“We’re asking [the FDA] to do something that they are
required to do under the law, that they failed to do under the law,” said
Sandra Daussin, attorney for the plaintiffs and a plaintiff herself who worked
for over 25 years as a regulatory chemist for agricultural products and
environmental protection.
Under its own regulations, the FDA is required to respond to petitions within 180 days, but the agency failed to address the petition after more than a year, an “arbitrary and capricious” delay, the complaint alleges.
PFAS are a class of thousands of chemicals used for decades
across many industries. The chemicals have become ubiquitous in the
environment, found in water, soil and the blood of animals and people around
the globe. Many types of PFAS have been found to be health hazards, linked to
disease and disability. The petition cites connections between seven types of
PFAS and “serious life-threatening health effects,” including kidney and liver
damage, cancer, neurotoxicity, immunotoxicity, and adverse reproductive effects.
The petitioners argue that in August 2023 the FDA developed
a validated method for detecting up to 30 PFAS chemicals in foods, and thus has
an obligation to use that knowledge to set enforceable limits. The group wants
the FDA to adjust those limits to be lower if methodology improves to detect
smaller concentrations.
The FDA has been testing foods for PFAS contamination since
2019 but so far says it has found very little contamination.
Mark Moorman, director of FDA’s Office of Food Safety,
acknowledged the petition in an April 2024 letter, but said that
the FDA had not yet reached a decision “due to competing agency priorities” and
that the petition was “currently under active evaluation by our staff.”
“They just ignored us,” Daussin said. She said she believes
the agency does not want to set limits “because they know they’re going to find
PFAS in food and that’s going to cause a problem.”
Plaintiff Linda Shosie of the Tucson Environmental Justice
Task Force alleges in the complaint that many of her friends and family members
have suffered severe illnesses and even died as a result of exposure to toxic
chemicals, including PFAS.
Plaintiff Arno Krotzky alleges he suffers from kidney and
immune system problems linked to PFAS exposure.
When asked for comment on the lawsuit, the FDA said that the
US Department of Health and Human Services has issued a short pause on mass
communications “that are not directly related to emergencies or critical to
preserving health” under the new Trump administration.
The lawsuit comes after the US Environmental Protection
Agency last week withdrew a draft
rule that proposed setting limits on PFAS in industrial discharge following
an executive order from
the new Trump administration that put a freeze on new federal regulations
pending review. PFAS discharged into waterways can contaminate drinking water
and soil where crops are grown.
Last year, the EPA finalized the first legally enforceable limits for
six PFAS chemicals in drinking water while last February the FDA announced it
is eliminating the sale of food
packaging that contains PFAS.
FDA testing of food for PFAS is ongoing, but as of last
April the agency had tested almost 1,300 food samples for PFAS, according to
the FDA’s website. In a set of
92 samples collected from one region, the agency reported finding PFAS in six
samples, including beef, shrimp and fish.
In an April 2024 update,
the agency said that exposure to PFAS at the levels it measured in these
samples “is not likely to be a health concern for young children or the general
population, based on evaluation of each PFAS for which there is a toxicological
reference value,” adding that no PFAS have been detected in 97% of foods tested
through the study to date.
Independent analyses have raised concerns that PFAS could be
more prevalent in the food supply than the FDA’s data suggests.
In 2023, the organization Alliance for Natural Health
USA tested eight
kale samples purchased from grocery stores in New York, Georgia, Pennsylvania
and Arizona, finding PFAS in all but one sample.
“Our testing directly contradicts the FDA’s complacent
attitude when it comes to PFAS contamination of our food supply, leaving
serious questions about the agency’s assessment of the safety of our food,”
said the group in a statement.
In 2024, the nonprofit Consumer Reports tested 50 samples of
whole milk from five states known to have PFAS contamination in their
groundwater, finding two particularly harmful PFAS chemicals, PFOS and PFOA, in
six samples.
“The results of our limited spot check don’t (and can’t)
show that our food supply is dangerously contaminated or that all milk contains
the toxic chemicals,” Consumer Reports said in a statement. “But the
results also raised some red flags. The levels of those two PFAS were higher
than previously found in limited sampling by the FDA, and high enough that in
the European Union, they would have triggered investigations.”
As the new Trump administration begins, it’s “anybody’s
guess” whether or not the FDA will fulfill the petition’s request to set limits
on PFAS in foods, said Daussin.
“In reality, this aligns quite well with this idea of ‘let’s
make America healthy again,” she said, referring to the agenda of
Robert F. Kennedy Jr., Trump’s nominee for Secretary of Health and Human
Services who testified at two senate confirmation hearings this
week.
“If we’re just talking about law, it doesn’t matter what
administration they’re under.”