Per- and polyfluoroalkyl substances are a group of synthetic chemicals, more commonly referred to as PFAS, that have been used in various industrial and consumer products since the 1940s, largely due to their resistance to heat, water, and oil. What Are PFAS?, Ctrs. for Disease Control & Prevention, Agency for Toxic Substances & Disease Registry (Jan. 18, 2024). However, these same properties that make PFAS so useful also make them notoriously persistent in the environment and the human body, leading to widespread contamination and significant health concerns. PFAS have become an increasing concern for the food and beverage industry in particular. This article explores the implications of PFAS contamination, the potential health risks, the challenges of regulatory compliance, and the inevitability of litigation for the food and beverage sector.
PFAS can enter the food and beverage supply chain via multiple avenues. For example, environmental contamination is a primary contributor of PFAS to the supply chain as a result of industrial discharges, firefighting foam runoff, and certain sewage sludge used as fertilizer that results in contaminated soil and water sources. Contaminated water or soil then can lead to PFAS uptake in crops and livestock. Rossella Ghisi, et al., Accumulation of Perfluorinated Alkyl Substances (PFAS) in Agricultural Plants: A Review, Env’t Rsch. (Feb. 2019). Similarly, food and beverage processing equipment containing PFAS-based nonstick coatings and lubricants may leach into food products. Testing Food for PFAS and Assessing Dietary Exposure, Food & Drug Admin. (Apr. 18, 2024).
Until very recently, food packaging materials like grease-proof paper and cardboard often contained PFAS obviously in close contact with food products. However, on February 28, 2024, the U.S. Food and Drug Administration (FDA) announced that grease-proofing materials containing PFAS are no longer being sold for use in food packaging in the United States. FDA, Industry Actions End Sales of PFAS Used in US Food Packaging, Food & Drug Admin. (Feb. 28, 2024). In so announcing, the FDA noted that the major source of dietary exposure to PFAS from food packaging—like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags—was being eliminated. The FDA also noted that its announcement marked the fulfillment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the United States.
In response to increasing regulatory and consumer pressure, many companies are actively seeking substitutes for PFAS. Alternatives to PFAS include fluorine-free formulations in products such as food packaging, firefighting foams, and textile treatments. For instance, some manufacturers have turned to wax-based coatings for food wrappers and containers, which offer similar levels of grease resistance without using PFAS. Others have adopted silicone-based technologies for moisture and stain resistance in fabrics, which not only avoid the use of harmful chemicals but also tend to be more biodegradable.
The U.S. Environmental Protection Agency (EPA) supports these initiatives through its Safer Choice program, which helps consumers and businesses find products that perform well and are safer for human health and the environment. Safer Choice Standard Criteria, Env’t Prot. Agency (Jan. 24, 2024). Products that bear the Safer Choice label have been rigorously evaluated, ensuring that they contain ingredients that meet strict safety criteria. The program particularly emphasizes the exclusion of PFAS, among other hazardous chemicals, which aligns with growing environmental health standards. This endorsement not only aids consumers in making informed decisions but also encourages manufacturers to reformulate products, driving innovation toward safer and more sustainable alternatives. The FDA continues to test a wide range of foods for PFAS, focusing on understanding exposure levels and potential health risks. Studies have indicated that while PFAS are present in the environment, their occurrence in food, especially seafood, is of particular concern. Questions and Answers on PFAS in Food, Food & Drug Admin. (Apr. 29, 2024). The FDA’’s findings on PFAS in seafood have led to voluntary recalls and ongoing testing to ensure food safety. For example, in 2022 Bumble Bee Foods, LLC, issued a voluntary recall of its canned clams due to detectable levels of PFAS.
Many have asked what the big PFAS fuss is all about, as the substances have been around for roughly 85 years, serve a multitude of functional purposes, and have come to be known as “forever chemicals.” EPA provides an answer, noting that peer-reviewed scientific studies have shown that exposures to PFAS may be harmful to human health. More particularly, the agency found those studies demonstrate that PFAS exposure has been linked to various adverse health effects, including increased cholesterol levels, high blood pressure, developmental effects, immune response decreases, liver function changes, and increased cancer risks. These health concerns underscore the looming stringent regulatory measures and related compliance challenges for industry. Our Current Understanding of the Human Health and Environmental Risks of PFAS, Env’t Prot. Agency (May 16, 2024).
In April 2024, EPA also took two monumental regulatory steps. First, it published a final rule designating perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund. Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 89 Fed. Reg. 39,124 (May 8, 2024) (to be codified at 40 C.F.R. pt. 302). This designation is critical because it enhances transparency and accountability in cleaning up PFAS contamination. By identifying and remediating contaminated sites, EPA aims to hold responsible parties accountable for their contributions to environmental pollution. The rule took effect July 8, 2024.
Second, on April 10, 2024, EPA finalized the National Primary Drinking Water Regulation (NPDWR) for PFAS. This regulation sets legally enforceable levels, or maximum contaminant levels (MCLs), for six PFAS compounds in drinking water: PFOA, PFOS, PFHxS, PFNA, HFPO-DA, and mixtures containing PFHxS, PFNA, HFPO-DA, and PFBS. Public water systems are now required to monitor for these PFAS, provide public notifications, and implement solutions to reduce PFAS levels if they exceed the MCLs. PFAS National Primary Drinking Water Regulation, 89 Fed. Reg. 32,532 (Apr. 26, 2024) (to be codified at 40 C.F.R. pts. 141, 142).
The NPDWR, which became effective on June 25, 2024, mandates that public water systems must monitor PFAS levels and report the findings to the public by 2027. Initial monitoring must be completed within three years, followed by ongoing compliance monitoring. If PFAS levels exceed the MCLs, water systems have until 2029 to implement corrective actions. Noncompliance requires immediate public notification and subsequent corrective measures. To support these efforts, EPA has allocated $1 billion through the Bipartisan Infrastructure Law to aid states, territories, and private well owners in PFAS testing and treatment, ensuring that all communities have access to clean and safe water.
The designation of PFAS as hazardous substances under CERCLA opens the door for increased litigation, as affected communities and individuals seek redress for contamination and health impacts. Companies in the food and beverage industry must be vigilant in their compliance efforts to mitigate potential legal liabilities. Implementing best practices for PFAS testing, monitoring, and reporting can help companies manage risks and demonstrate their commitment to public health and safety. This includes regular audits, employee training, and staying abreast of regulatory developments.
Some in the food and beverage industry could face significant exposure under CERCLA for past PFAS contamination if they historically used PFAS-containing products and materials. As these chemicals are persistent and bioaccumulative, past discharges into the environment can lead to long-term contamination issues. Now recognized as CERCLA hazardous substances, PFAS may create new liability and remedial risks to industry.
Furthermore, EPA’s PFAS NPDWR could impact the food and beverage industry as upstream sources. Companies using contaminated water in their processes may need to implement costly treatment solutions to comply with the new standards. Additionally, if their operations contribute to PFAS contamination in local water supplies, they could face increased scrutiny and potential liability for cleanup under CERCLA. Industry should proactively manage PFAS risks by assessing their supply chains, mitigating current contamination sources, and staying informed about regulatory changes to avoid significant financial and legal repercussions.
EPA’s regulation of PFAS, particularly through the designation of PFOA and PFOS as hazardous substances and the establishment of the NPDWR, represents a significant milestone in protecting public health and the environment. The food and beverage industry’s voluntary ban on PFAS in food packaging further illustrates the collaborative efforts to address this complex issue.
The implications of PFAS regulation extend beyond compliance, highlighting the importance of proactive measures to ensure food safety and public health. Implementation of effective compliance and risk management strategies can help companies mitigate legal liabilities and contribute to the broader goal of ensuring safe and sustainable food systems. As research on PFAS continues to evolve, staying informed and adapting to new findings will be essential for the food and beverage industry and legal professionals alike.
