State and federal regulations are closing in on per- and poly-fluoroalkyl substances (PFAS), and companies need to be mindful of these substances in their operations and incoming regulations to avoid litigation.
PFAS is a family of chemicals that can number between 5,000 and 15,000 depending on the definition used, says Tom Lee, environmental law expert and partner at Bryan, Cave, Leighton, and Paisner LLC (BCLP), who spoke at the November 2 PFAS: Impact on the Planet and Solutions for the Packaging Industry event in Madison, Wisconsin.
“These chemicals are widely used, they are present in our modern economy in a lot of ways that people are still learning and beginning to understand, and of course, they have been heavily used in food packaging,” Lee says, citing a Consumer Reports study that found PFAS in various food packaging solutions.
PFAS have been linked to a variety of negative health effects, including decreased fertility, developmental effects or delays in children, and increased risk of some cancers, according to the U.S. Environmental Protection Agency (EPA.
PFAS Regulations on the Federal Level
The FDA has watched PFAS and their presence in the food supply since the mid-2000s and has included the chemicals in its total diet studies since 2019, says Brandon Neuschafer, another environmental law partner at BCLP who spoke alongside Lee at the PFAS event.
In 2011, the FDA and manufacturers voluntarily agreed to phase out long-chain PFAS, and the FDA subsequently removed their food-contact approval. Short-chain PFAS are still relevant in food contact packaging, though, and are increasingly under scrutiny.
Studies have found that the short-chain PFAS 6:2 fluorotelomer alcohol (6:2 FTOH), for example, is both “bio-persistent and more toxic than other short-chain chemistry,” Neuschafer says, “so the industry is starting to phase out even some of the shorter chain chemistries.”
Neuschafer says while PFAS can include thousands of different chemicals, “there are only seven chemistries that [the FDA] can perform adequate human health assessments on when discovered in food.”
That disconnect makes it difficult for the FDA to advise companies on whether the presence of various PFAS constitutes a safety risk, “but from a legal perspective, that’s not going to stop others, like plaintiffs’ attorneys, from making their own assessments,” he says.
There is currently no federal legislation limiting or banning PFAS in food packaging; instead, FDA mandates, and especially state-level legislation, are prompting action from the industry.
State-Level PFAS Regulations
States generally accept the definition of PFAS as a class of organic chemicals containing at least one fully fluorinated carbon atom, and most focus on prohibiting the intentional use or addition of these chemicals into food contact surfaces.
“The problem is, states are defining all of these incredibly relevant, incredibly important terms differently,” Neuschafer says. “Different states have different definitions of PFAS; different states have different definitions of what it means to be intentionally added.”
This patchwork of state laws for PFAS in food packaging, currently spanning 12 states, makes it difficult for companies to strategize their supply chain and distribution.
California and New York were the first to pass laws regulating PFAS in food packaging. Their regulations are similar, with both prohibiting intentionally added PFAS in plant fiber-based food packaging. Both states’ laws went into effect at the beginning of 2023.
California added an extra stipulation in addition to the term “intentionally added” to include the presence of more than 100 parts per million of total organic fluorine in a food contact surface.
“Other states haven’t really adopted those types of set limits, but it’s an interesting sort of benchmark value for setting restricted substance list limits,” Lee says. “We’re seeing retailers start to incorporate that particular value.”
The California law does not order a particular test method for measuring total organic fluorine, though, which Lee says is “something that businesses need to think about as they’re considering compliance.”
Vermont became the first state to enact a law that applies to all food packaging, rather than just fiber-based packs, effective July 1, 2023.
“It’s still limited to direct food-contact surfaces,” Lee says, “but it pulls in things like fluorinated HDPE containers, beverage containers that may have a fluorinated lining, really any kind of food packaging where you intend PFAS to be present in the food or beverage contact surface.”
Rhode Island was next out the gate as a “little state with a big law,” Lee says, as the new regulation pushes upstream into the manufacturing process. It prohibits the use of regulated chemicals as a processing agent, mold release agent, or intermediate.
The Rhode Island law’s effective date was extended from January 2024 to July 2024.
Minnesota has put forward the broadest state law so far, Lee says, as the state’s regulation applies to shipping containers in addition to unit packages and intermediate packages, effective January 1, 2024.
“We’ll see how they do with holding this deadline,” he says, citing Rhode Island’s extension in the face of regulatory pushback.
“When you start talking about regulating intentionally added PFAS in non-food contact shipping products, that’s an industry that hasn’t been aware of this yet and probably is not as far along the curve of finding alternatives and solutions,” compared to food-contact packaging manufacturers, Lee says.
Enforcement on the State and Third-Party Level
Several food-contact PFAS laws may be in the books or in the pipeline in the U.S., but enforcement of these laws is still uncertain.
California’s AB 1200 law regulating PFAS in food packaging and cookware, for example, doesn’t identify an agency to be responsible for enforcement. In October 2023, 10 months after the law’s effective date, California’s attorney general issued a letter to food packaging and cookware manufacturers notifying them that they would take over enforcement responsibility.
“Most of these state laws include some penalty provisions,” Lee explains, “but there are other state laws that also don’t identify an agency, and create challenges, frankly, for that state actually implementing these laws which have these huge impacts on the industry.”
Now that California’s attorney general is on the case and focusing on PFAS as a core issue, “we could see some very impactful enforcement over the next few months,” Lee says.
State-level enforcement is far from companies’ only worry in this space, as companies are facing lawsuits related to the presence of PFAS in their products.
The allegations at the core of these lawsuits have been based on false advertising. Plaintiffs are pointing to value statements including “food safety, responsible sourcing, and natural, simple ingredients,” and arguing that the presence of PFAS renders such statements false or misleading, Lee says.
In one active litigation, the plaintiff has claimed false advertising against butter brand Kerrygold for its on-pack “pure Irish butter” claim.
The plaintiff opened the lawsuit not based on the presence of PFAS in testing but because the butter was recalled and reintroduced on store shelves around the time New York’s PFAS law went into effect.
“They allege that the only reason that would’ve happened is [that] the packaging contained PFAS previously, and it was being replaced with a non-PFAS food packaging, and therefore, the claim ‘pure Irish butter’ is false and misleading,” Lee explains.
The suit may not be centered around concrete testing, but the company will likely have to spend time and legal fees in defense regardless.
How Companies Can Protect Themselves
Industry players need to take several steps to navigate this complex and evolving regulatory landscape.
First and foremost, Neuschafer says, companies need to identify an internal compliance team.
“This regulation of packaging content often falls within a gap within organizations,” he says. “So, the first thing we have to do is assemble the right team that includes the regulatory and technical experts and the procurement folks.”
With the help of this newly formed team, companies also need to dig into their supply chain and understand where and how PFAS is being used, not only in the finished product but also in manufacturing and other upstream uses.
Neuschafer acknowledges the difficulty of finding clear answers up the supply chain, as a supplier may not have all the answers regarding its own supplier or raw material provider.
New York specified that companies could rely on PFAS compliance certifications from suppliers rather than conducting their own tests, but “it’s not like there’s one standard paragraph that has to be included,” Neuschafer explains.
“These things can be negotiated; they can be qualified. Lawyers come in and say, ‘To the best of our knowledge,’ or ‘We don’t think.’ That gets difficult to deal with,” he said.
Contractual requirements can be a safeguard against an opaque supplier situation if a company can impose upon suppliers a duty to comply with these new PFAS laws. This may end up requiring a modification to packaging specifications, which Neuschafer admits is easier said than done.
Marketing teams need to also be careful with their claims, considering how these chemicals might be present and how that can create legal vulnerabilities.
Lastly, Neuschafer urges companies to “document everything.”
“That’s a general rule in food safety and food production, but you have to document it to be able to demonstrate that you did the analysis,” he says.
By taking proactive steps to understand and comply with state laws and by carefully managing their marketing claims and supply chain, packaging and processing companies can better navigate the evolving PFAS landscape.