According to documents obtained by researchers* and reported to the public by the media, Big Chemical companies DuPont and Daikin knew the dangers of a PFAS chemical compound widely used in food packaging** since 2010, but hid them from the public and the U.S. Food and Drug Administration (FDA). According to the report, the chemical 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 “forever chemicals”) and submitted internal studies to support that claim.
The FDA is Also to Blame
Industry reports and communications among the FDA and PFAS producers between 2008 and 2020 show how a sequence of inadequate chemical safety analyses, hidden studies and lax oversight created a scenario in which U.S. consumers continue to be exposed to the dangerous compound in food packaging.
For instance, DuPont submitted PFAS 6:2 FTOH studies to the FDA back in 2008 that monitored the impact of high exposure levels to the chemical on two generations of lab rats. The animals suffered kidney failure, liver damage, mammary gland problems, mottled teeth and other issues. However, both DuPont and the FDA decided that humans’ exposure would be much lower and, with little supporting evidence, concluded that the short chain PFAS would not accumulate in human bodies.***
Overview of Big Chemical’s Deception
(1) Daikin Chemical withheld a 2009 study that indicated toxicity to lab rats’ livers and kidneys; (2) From as far back as 2012, DuPont Chemical failed to alert the FDA or the public to new internal data that indicated that the PFAS 6:2 FTOH chemical stays in animals’ bodies for much longer than initially believed.
The Daiken Chemical Deception
In 2009 the FDA approved the Daikin-developed 6:2 FTOH compound for use in food packaging, partly basing the decision on the company’s studies that suggested that the chemical was non-toxic.
But about 10 years later, researchers discovered that Daikin had withheld two studies from the FDA that suggested toxicity to lab animals’ livers and kidneys at low exposure levels – one completed before the FDA approved the chemical, and one after.
Independent researchers caught the omission by cross-checking studies for the chemical posted to Daikin’s website with those submitted to the FDA, and found the data on health effects was never given to the FDA– despite the fact that the law required the first study to be submitted to the FDA. When the independent researchers asked Daikin officials about the omission, the company responded by removing the report from its website.****
The Dupont Chemical Deception
A full three years after they learned about the potential harms of the PFAS chemical in food packaging, in 2015 DuPont partially summarized its 2012 findings of a peer-reviewed 6:2 FTOH study that reportedly used “cherry-picked” data to support its claim that the compound was safe. Though it omitted the 2012 study’s details, communications show it caught the attention of the FDA, which wrote that the study alerted the agency “to potential biopersistence of [6:2 FTOH] and raised potential safety concerns”.
That triggered a safety review, but the process would drag out for about five more years as U.S. consumers unknowingly continued to be exposed to the PFAS chemical leaching into their food.
Although Daikin may have broken the law, Daiken and DuPont, which has previously been caught hiding studies that suggest toxicity in PFAS, are not facing any repercussions.
Why is the deception by Big Chemical companies a problem?
Numerous scientific studies conducted by independent researchers, as well as the FDA, now links PFAS 6:2 FTOH***** to kidney disease, liver damage, cancer, neurological damage, developmental problems and autoimmune disorders, while researchers also found higher mortality rates among young animals and mothers exposed to the chemicals.
FDA Offers a Long, Protracted Grace Period for the Chemical Companies
Between 2018 and 2020, three FDA analyses that included Daikin’s and DuPont’s studies broadly concluded that 6:2 FTOH PFAS chemical may stick in the human body for years and could be more toxic than the companies had previously suggested. Yet, the FDA reached agreements with some major PFAS manufacturers to voluntarily stop using 6:2 FTOH compounds in food packaging ‘within five years’. That was back in 2020. But documents show that the FDA first became aware of DuPont’s hidden study back in 2015, and public health advocates say a 10-year timeline to reassess and remove the chemical is unacceptable.
A 2019 communication between the FDA and the PFAS manufacturer Asahi showed urgency on the part of the agency to get the chemical removed from the market, yet in July 2020 it announced that four major producers of the compound had agreed to have all food packaging with 6:2 FTOH off the shelves by 2025.
Seizing on another public heath crisis to justify its protection of Big Chemical companies, in its announcement, the FDA wrote that the extended timeline, “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”.
The ethics of hiding known risks
The law does not require companies to make such information public, even though the results strongly suggested a health threat. According to Tom Neltner of the Environmental Defense Fund, DuPont for instance, had an ethical obligation to not just publish the study revealing the potential harms of the PFAS chemical being used in food packaging, but to flag it for the FDA.
*An official from the Environmental Defense Fund, along with an independent researcher, obtained the companies’ studies and related documents from Daikin’s website and the FDA through Freedom of Information Act requests.
**The PFAS chemicals in question are called ‘6:2 FTOH’, and are now linked to a range of serious health issues; U.S. consumers are still being exposed to them in grease-proof pizza boxes, carryout containers, fast-food wrappers, and paperboard packaging. (Other PFAS polyfluoroalkyl chemical compounds are commonly used in anti-stick products such as cookware and bake ware, as well as stain-resistant and water-resistant home care products. Due to the pervasive nature of PFAS chemicals, they also make an appearance in drinking water across the country.)
***Even when DuPont reported some health problems in lab animals at high exposure levels in its 2008 study, it did so in a way that appears designed to confuse. One passage that revealed that high doses of the chemical lead to blood in rats’ urine read that the doses “resulted in a significant reduction in the number of female rats with blood absent in the urine”.
****The report can still be found using the Wayback machine site.
*****The 6:2 FTOH compound is part of a newer generation of “short chain” PFAS that were designed to replace 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 have found that PFAS, regardless of chain length, accumulate in the environment and humans, and are toxic.