Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant
Last week, the Food and Drug Administration (FDA) announced the phase-out of per- and polyfluorinated alkyl substances (PFAS) used to greaseproof paper and paperboard food packaging made from a specific type of short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH). The action, narrow as it is, is welcome news for efforts to protect public health and the environment from the risks posed by short chain PFAS, known as “forever chemicals” because they do not degrade.
FDA secured voluntary agreements with three companies, Archroma, Asahi Glass, and Daikin, to phase-out products based on 6:2 FTOH. A fourth company, Chemours, asked FDA to suspend the agency’s approvals on its products containing the PFAS one year ago. The action affects 15 food contact substance notifications (FCN) approved by the agency between 2006 and 2016. It does not address 13 FCNs for similar greaseproofing uses made from PFAS other than 6:2 FTOH. And, under the agreement, consumers may still find 6:2 FTOH-laden, carry-out containers until June 2025.
The process FDA took, and the time it took to get there, reveals the significant difficulties the agency has in reversing past actions in the face of mounting evidence of a chemical’s risk:
- FDA must seek out information because companies have no obligation to affirmatively notify the agency of new studies showing potential problems;
- When FDA finds the information and identifies potential safety concerns, it appears to act as if it has the burden of proving the use is no longer safe; and
- FDA continued approving uses of 6:2 FTOH even after it identified problematic data gaps.
These difficulties reinforce the need for actions being taken by states such as Washington, Maine, New York, and California, by Congress, and by retailers to reduce uses of PFAS in their products. When it comes to food packaging, PFAS are dinosaurs and their time is running out.
FDA’s announcement follows a flawed precedent set in 2012
The action FDA announced last week is similar to one it negotiated in 2012 with three companies to voluntarily suspend seven FCNs for long-chain PFAS (PFAS with chains of eight or more carbons with all of the hydrogens replaced with fluorine). In that case, the agency acted because the class of chemicals were likely carcinogens, and the companies agreed to suspend interstate commerce rather than conduct the studies FDA said were needed to demonstrate safety.
In announcing the agreement, FDA did not provide a scientific rationale for drawing a bright line between long-chain and short-chain PFAS. As a regulator, it also failed to explain why it did not follow the process laid out in its regulations to revoke an FCN. Because the companies agreed, the agency didn’t have to explain itself. Now, the story repeats itself.
The chase for information
In a January 2015 peer-reviewed article FDA scientist, Dr. Penelope Rice, flagged 6:2 FTOH as a potential problem. The article identified important gaps in the safety data and indicated that relevant studies were needed to ensure 6:2 FTOH was a safer alternative to long-chain PFAS. By then, FDA had already authorized FCNs using the substance to greaseproof paper and paperboard.
But here is the key problem: in 2012, DuPont’s scientists had published an abstract showing that 6:2 FTOH bioaccumulated in lab animals. If FDA had been informed of the study, it would not have authorized at least five FCNs between 2012 and 2016 and should have acted to revoke the prior authorizations. The action we are seeing now could have taken place years earlier if the companies had affirmatively provided FDA with the relevant information.
Lacking companies’ data, as we reported in a February 2019 blog, Dr. Rice and her FDA colleagues, Dr. Kabadi and others, continued their investigation and published a February 2018 peer-reviewed article showing that a metabolite of 6:2 FTOH was likely to bioaccumulate in people. It was an important finding because bioaccumulation is a key problem with long-chain PFAS, and FDA did not consider its risk when approving the uses of short-chain PFAS.
Rice and Kabadi published two more peer-reviewed articles in February and April of this year which not only confirmed their initial findings but also produced new evidence highlighting bioaccumulation and additional toxicity of 6:2 FTOH.
In October 2019, around the same time that FDA’s scientists submitted the two most recent articles to the journal, the agency also sent a letter to the three companies raising concerns that additional testing was needed to address safety questions. The agency explained that:
Based on information available to FDA after the above-listed FCNs became effective, FDA conducted an updated comprehensive review of current information on the safety of certain short-chain PFAS compounds. FDA’s assessment of the available data on these types of compounds has indicated the need to consider factors in addition to those traditionally considered by the Agency at similar exposure levels. These include additional possible toxic endpoints including, but not limited to, effects on pre- and post-natal development, reproductive health and function, and carcinogenicity. (FDA October 1, 2019 Letter to Daikin)
Based on FDA’s recent announcement, as in 2012, it seems the companies chose to “voluntarily suspend” the approved FCNs rather than conduct the studies that FDA requested.
What happens now?
Under the agreement, companies will have until January 1, 2024 to stop selling the PFAS covered by the notices. The agency justifies the 41-month timeframe by citing the pandemic stating that “this phased market removal balances uncertainty about the potential for public health risks with minimizing potential market disruptions during the COVID-19 public health emergency.” It also allows paper and paperboard treated with the chemicals to continue to be sold after the 41 months until inventories are gone. FDA indicated that clearing inventories should take 18 months – by June 2025.
Companies are required to submit reports to FDA in January 2022, 2023 and 2024 and July 2023 that include their annual market volume of the PFAS based on 6:2 FTOH and progress in reaching the deadlines.
The agreement also has a promising development; the companies are required to submit to FDA a sample of the PFAS covered by the FCNs to enable the agency to monitor the prevalence of these substances in the marketplace. We have been calling for FDA to require that for more than a year for all PFAS.
FDA’s ongoing challenge of reversing past approvals
The decision is good news. However, it highlights problems with FDA’s process for reversing past approvals. Specifically,
- FDA appears to have acted as if it had the burden of demonstrating the substance was unsafe rather than challenging the companies to demonstrate safety as the law requires. As a result, FDA took almost five years after the agency scientists first publicly reported significant gaps in the safety data on the reproductive and developmental risks posed by the 6:2 FTOH PFAS before asking the companies to fill the gaps. In the interim, FDA authorized as many as 4 of the 15 FCNs covered by last week’s announcement.
- FDA failed to acknowledge that it allowed 13 of the FCNs for other short-chain PFAS to remain on the market to greaseproof paper or explain why it is confident these other substances are safe. This could result in food packaging companies making a regrettable substitution from a 6:2 FTOH PFAS to one that has not yet been adequately evaluated.
- Companies making PFAS – or any food additive – have no duty to affirmatively notify FDA of new studies showing that information in their original notice is incomplete or incorrect. DuPont’s scientists published the key 2012 study that FDA relied on to determine that 6:2 FTOH bioaccumulated in humans. In its 2020 paper, FDA indicated it had “recently received additional data on 6:2 FTOH [emphasis added]” on which it drew its conclusions.
- FDA’s approach does not actually revoke the FCNs. Rather, the companies voluntarily suspended the FCNs, leaving them in limbo. As in 2012, the agency chose not to follow the process laid out in its regulations.
We anticipate that this is not the final step FDA will need to take to adequately protect the public from the risks posed by short-chain PFAS in food packaging. Without timely and transparent action by the agency or rigorous analysis to differentiate why some short-chain PFAS but not the others are safe, it’s no wonder that states and some Representatives in Congress have called for a complete ban of PFAS in food packaging.