FDA’s Current Standpoint on PFAS Includes Phaseouts and Regulatory Changes
The FDA is currently monitoring a phase-out of short chain PFAS and proposing regulatory changes to improve its ability to revoke food contact authorizations for such substances.
The FDA's proposed changes to food contact notification regulations would apply to all food contact substances, not just PFAS.
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The FDA is proposing regulatory changes and monitoring certain food contact substance phase-outs to help limit the use of per- and polyfluoroalkyl substances (PFAS) in food packaging.
PFAS is commonly used in four main food-contact areas: non-stick applications, food processing equipment parts, processing aids, and grease-proofing agents, according to Dr. Sharon Koh-Fallet, regulatory review branch chief at the FDA’s division of food contact substances. Koh-Fallet spoke at the November 2 PFAS: Impact on the Planet and Solutions for the Packaging Industry event in Madison, Wisconsin.
Dozens of attendees listened in on Koh-Fallet's presentation at the November 2 PFAS even in Madison, WI.Certain PFAS are persistent in the environment, and can accumulate in plants, animals, and humans, and are associated with adverse health effects in humans and animals.
“Whether that’s immunotoxicity, or reproductive and developmental toxicity, which are some of the more common toxicity effects that we’ve seen,” Koh-Fallet explains, adding, “for some certain PFAS, there’s also been evidence of carcinogenicity as well as other systemic toxicity.”
FDA Monitoring PFAS Phaseouts
Industries have already phased out some more dangerous PFAS types. A phase-out of perfluorooctane sulfonic acid (PFOS) began in 2000, and a voluntary industry agreement was made in 2011 to discontinue the use of seven long-chain PFAS that were authorized under the Food Contact Notification (FCN) program.
In 2016, the FDA revoked FCN authorization of three of these long-chain PFAS due to safety concerns, and two more based on abandonment or discontinued use.
Regulations are tightening for short-chain PFAS as well. The FDA recently conducted a post-market review of the short-chain PFAS 6:2 fluorotelomer alcohol (6:2 FTOH) and found bio-persistence and increased risks of immunotoxicity, developmental and reproductive issues, and carcinogenicity.
The FDA approached manufacturers of these short-chain substances in 2020, “and one had already actually stopped selling in the U.S. market, and the other three companies agreed to [phase] out their materials,” Koh-Fallet says.
The phase-out terms included a starting point in January 2021 and completion in December 2023, with “annual reports to give [FDA] updates on the phase-out as well as a mid-year report in the final year,” says Koh-Fallet.
If available, the manufacturers also agreed to provide samples of these substances to help the FDA develop tracking methods for future compliance.
Manufacturers also said they expect existing stocks of these substances to exhaust supply chains within about 18 months after discontinuing sales.
These short-chain PFAS may soon be a thing of the past in a practical sense, but their FCN authorizations are still in place.
That’s partly why the FDA in 2022 proposed revisions to 21 CFR 170.105, its guideline to determine an FCN is no longer effective.
The revision would expand the FDA’s ability to revoke FCNs for more than just PFAS, “though that’s probably the most pertinent example currently,” Koh-Fallet says.
Currently, the FDA has separate processes for revoking existing authorization between food additive regulations (under 21 CFR 171.130) and food contact notifications.
For food additives, or “something that’s added to food and is intended to have an effect on the food,” authorization can be revoked based on new safety information, abandonment, or experience with existing regulations, which covers duplicity or inapplicability, Koh-Fallet says.
The FDA defines food contact substances as intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, without an intent to have a technical effect on the food.
The current administrative process for revoking food contact notifications allows for revocation only based on new safety information.
“This basically means that [FDA] can only remove if we made a safety determination that the use is no longer safe,” Koh-Fallet says. “There is no mechanism for us to remove it based on abandonment; there’s no mechanism for us to remove it if it’s duplicative, and that’s somewhat constraining for the FCN program.”
For the short-chain PFAS currently being phased out, the FDA would have to make a safety determination to remove their authorization, despite them being one foot out the door already.
The FDA’s proposal would allow it to “not only make a determination under safety,” Koh-Fallet explains, “but also allow us to remove an FCN from being effective if it’s abandoned, or if there are duplicative authorizations, such as a food additive regulation that covers the use or a threshold of regulation exemption.”
The proposal is yet to be set in stone, but the administration is currently working on getting the final rule published.
As the regulatory framework surrounding PFAS and other food contact substances evolves, it is crucial for packaging manufacturers to stay aware of these changes and ensure compliance, not only to avoid regulatory trouble, but also to maintain product safety for consumers.
Dozens of attendees listened in on Koh-Fallet's presentation at the November 2 PFAS even in Madison, WI.
