Chemical giants DuPont and Daikin have known about the dangers of a PFAS compound widely used in food packaging since 2010, but have hidden them from the public and the Food and Drug Administration (FDA), company studies obtained by The Guardian reveal.
The chemicals, called 6: 2 FTOH, are now linked to a variety of serious health problems, and Americans are still exposed to them in grease-proof pizza boxes, take-out containers, fast food wrappers and food packaging. paperboard.
The companies initially told the FDA that the compounds were safer and less likely to accumulate in humans than older types of PFAS, also known as “permanent chemicals,” and submitted internal studies to back up that claim.
But Daikin withheld a 2009 study that indicated toxicity to the liver and kidneys of laboratory rats, while DuPont in 2012 did not alert the FDA or the public to new internal data indicating that the chemical remains in the bodies of animals for much longer than was initially thought.
Industry science, the FDA, and independent researchers now link FTOH 6: 2 to kidney disease, liver damage, cancer, neurological damage, developmental problems, and autoimmune disorders, while researchers also found higher death rates among young animals and mothers exposed to chemicals.
If the FDA had seen the data, it’s unlikely it would have approved FTOH 6: 2, said Maricel Maffini, an independent researcher who studies PFAS in food packaging. And while Daikin may have broken the law, he and DuPont, who has previously been caught hiding studies suggesting toxicity in PFAS, they are not facing repercussions.
“Those things shouldn’t happen, and if they happen, then there should be consequences, but supervision is lax,” Maffini said.
In 2020, the FDA reached agreements with some of the major PFAS manufacturers to voluntarily stop using FTOH 6: 2 compounds in food packaging within five years. But the documents show that the FDA first learned of the hidden DuPont study in 2015, and public health advocates say a 10-year window to reevaluate and phase out the chemical is unacceptable.
Additionally, the FDA removal only applies to 6: 2 FTOH compounds and does not include other similar “short chain” PFAS, raising questions about whether the agency is fully protecting the public from the potentially toxic class of chemicals. .
“I think people should be able to trust the FDA to turn science in agency into real action, and right now that doesn’t seem to be the case,” said Tom Neltner, director of chemicals policy for the Environmental Defense Fund. He and Maffini obtained the company studies and related documents from the Daikin website and the FDA through Freedom of Information Act requests.
The 6: 2 FTOH compound is part of a new generation of “short chain” PFAS that were designed to replace the older and supposedly more harmful “long chain” PFAS. The industry claims that short chain compounds are uniformly safe and “practically non-toxic”. However, independent researchers such as Erika Schreder, scientific director of Toxic Free Future, have found that PFAS, regardless of chain length, accumulate in the environment and in humans and are toxic.
“The fact that we continue to discover evidence that PFAS in current use has similar toxicity to [long chain] Compounds that have been removed make a strong argument for regulating harmful chemicals like PFAS as a class, ”said Schreder.
In a statement to The Guardian, an FDA spokesperson defended the agency’s handling of FTOH 6: 2, noting that the studies “do not demonstrate an imminent health hazard” and that more studies were needed to draw conclusions. specific information about your safety and that of other short-chain PFASs.
Daikin and Chemours, a company that spun off from DuPont’s PFAS division in 2015, did not respond to requests for comment.
DuPont hides alarming new data
Industry reports and communications between the FDA and PFAS producers between 2008 and 2020 show how a sequence of inappropriate chemical safety tests, hidden studies, and lax oversight created a scenario where Americans continue to be exposed to the dangerous compound in food packaging.
The 2008 FTOH 6: 2 studies that DuPont submitted to the FDA monitored the impact of high levels of exposure to the chemical in two generations of laboratory rats. The animals suffered kidney failure, liver damage, mammary gland problems, speckled teeth, and other problems. However, DuPont and the FDA considered human exposure to be much lower and, with little supporting evidence, believed that short-chain PFAS would not accumulate in human bodies, Maffini said.
She called such studies on PFAS “inaccurate and inappropriate” because the chemicals are toxic at “extremely low levels” and are known to accumulate in the bodies of animals.
In fact, the longer-term DuPont study completed in 2012 found that 6: 2 FTOH remained in the bodies of laboratory animals for longer than previously thought. Still, DuPont did not alert the FDA or publish the study.
Although the law does not require companies to release such information, the results strongly suggested a health threat, and DuPont “had an ethical obligation not only to publish it, but to report it to the FDA,” Neltner said.
Three years later, DuPont partially summarized its 2012 findings in a peer-reviewed 6: 2 FTOH study that Maffini said used “selected” data to support its claim that the compound was safe. Although it omitted the details of the 2012 study, the communications show that it came to the attention of the FDA, which wrote that the study alerted the agency “to a possible biopersistence of [6:2 FTOH] and raised potential security issues. “
That triggered a security review, but the process would drag on for about five years while Americans remained exposed.
Even when DuPont in its 2008 study reported some health problems in laboratory animals at high levels of exposure, it did so in a way that seems designed to mislead, Maffini noted. A passage that revealed that high doses of the chemical lead to blood in the urine of rats said that the doses “resulted in a significant reduction in the number of female rats with no blood in the urine.”
Daikin skips the preyno science
The FDA approved the FTOH 6: 2 compound developed by Daikin for use in food packaging in 2009, basing the decision in part on the company’s studies that suggested the chemical was non-toxic.
But about ten years later, Maffini and Neltner discovered that Daikin had withheld two FDA studies that suggested toxicity to the liver and kidneys of laboratory animals at low exposure levels: one was completed before the FDA approved the chemical and another after.
They found the omission by checking the studies of the chemical published on the Daikin website with the sent to the FDA, and found that data on health effects was never released to the agency. Neltner noted that the law required that the first study be submitted to the FDA. Maffini said Daikin was asked about the omission and the company responded by removing the report from its website, but it can still be found using the Wayback machine. site.
As part of its chemical safety review, the FDA convened a 2018 meeting with Chemours, Daikin, and others in the industry in which the agency requested studies related to 6: 2 FTOH. The communications confirm that the FDA did not have the 2012 DuPont study or the 2007 Daikin study.
Between 2018 and 2020, Three FDA analysis what included Studies by Daikin and DuPont widely concluded that FTOH 6: 2 can linger in the human body for years and could be more toxic than companies had previously suggested.
A 2019 communication between the FDA and PFAS manufacturer Asahi showed urgency on the part of the agency to remove the chemical from the market, but in July 2020 Announced that four major producers of the compound had agreed to have all 6: 2 FTOH food packages off the shelves by 2025.
In its announcement, the FDA wrote that the extended schedule “balances uncertainty about the potential for public health risks with minimizing potential market disruptions to food packaging supply chains during the Covid-19 public health emergency. 19 “.
Maffini wondered if public health was being prioritized.
“The agency’s own scientists were in a rush to get it off the market, so it’s really hard to understand why the FDA agreed to a five-year phase-out,” he said.
Neltner also highlighted what he and Maffini see as other shortcomings in the FDA chemical approval process that contributed to the 6: 2 FTOH problem: the agency does not require sufficient safety data upfront and there is no systematic reassessment for determine if chemicals are safe after they are shipped to market.
The FDA again defended its process, stating that the agency “updates our safety assessments as appropriate” and said that the industry “must provide sufficient information to demonstrate that” the chemicals are safe.
But Neltner said problems with 6: 2 FTOH suggest otherwise.
“They are making extremely inaccurate assumptions that are not defensible,” Neltner said.
George is Digismak’s reported cum editor with 13 years of experience in Journalism