The Environmental Protection Agency (EPA) recently released two proposed regulations that would classify nine per- and polyfluoroalkyl substances (PFAS) as “hazardous constituents” and expand oversight of waste facilities to PFAS and other substances. In addition to broadening the EPA’s authority to regulate PFAS, the EPA’s new rules would also likely lead to significant changes in the ever-expanding PFAS litigation, as plaintiffs would likely cite the “hazardous” classification and expanded oversight to support allegations that PFAS are harmful to humans.

Like the International Agency for Research on Cancer (IARC), which recently moved to expand its classifications to two of these nine PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) (see Defendants Can Leverage IARC Statement on TWO PFAS Compounds, PFOA and PFOS), the EPA has acknowledged the scientific community’s assessment of potential human toxicity is not final, despite its proposed “hazardous” classification. Given the potential prejudice resulting from jury arguments in personal injury and consumer class action cases that the EPA classifies certain PFAS as “hazardous,” if these rules are adopted PFAS defendants should consider requesting their exclusion as irrelevant and prejudicial.

RCRA and the EPA’S Rulemaking Process

Congress enacted RCRA to protect human health and the natural environment, conserve energy and natural resources, reduce and recycle waste, maintain environmental health, and ensure waste management in an environmentally conscious manner. In furtherance of these goals, RCRA established the Corrective Action program, which provides a system for the investigation, prevention, and remediation of “hazardous waste” and “hazardous constituents” released into soil, groundwater, or surface water at facilities such as RCRA-permitted treatment, storage, and disposal facilities (“TSD facilities”). The Act further provides basic federal regulations and waste disposal and tracking requirements that states adapt to fit their particular resources.

When the EPA determines new regulations are appropriate under RCRA, the EPA publishes a Notice of Proposed Rulemaking in the Federal Register. The EPA may subsequently consider comments submitted by members of the public, revise the proposed rule, and publish the final rule in the Federal Register. Thereafter, the final rule is codified through addition to the Code of Federal Regulations.

The EPA’s Proposed PFAS Regulations

In February 2024, the EPA published a proposed rule that would expand the definition of “hazardous constituents” under RCRA to add nine PFAS: perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorobutanesulfonic acid (PFBS), hexafluoropropylene oxidedimer acid (HFPO-DA or GenX), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), perfluorodecanoic acid (PFDA), perfluorohexanoic acid (PFHxA) and perfluorobutanoic acid (PFBA). To be listed as a “hazardous constituent” under RCRA, scientific studies must show that the substance has toxic, carcinogenic, mutagenic, or teratogenic effects on humans or other life forms. However, the EPA observes that the classification does not require a finalized toxicity assessment or exhaustive search and evaluation of all published studies. If the rule is adopted, these PFAS will be identified in assessments of TSD facilities, which may be required to undertake corrective action related to their treatment, storage, disposal, or release.

The EPA also proposed broadening the definition of “hazardous waste” subject to corrective action at TSD facilities. Presently, the regulations define “hazardous waste” based on its listing by the EPA or characteristics related to the substance’s ignitability, corrosivity, reactivity, and/or toxicity. The new proposed rule would loosen the definition of “hazardous waste” for corrective action requirements by including solid waste that may pose hazards to human health or the environment when improperly treated, stored, transported, or disposed.

Taken together, these proposed rules may require TSD facilities to take corrective action to investigate, prevent, and clean up the release of PFAS into certain environments—even if the particular PFAS has not been listed as a “hazardous waste.” In addition, the EPA notes that listing the nine PFAS as hazardous constituents “would form part of the basis for any future action [the EPA] may take to list these substances as hazardous waste,” which could result in entities that generate or transport the wastes being subject to new oversight and cleanup responsibilities.

Defenses Against Claims PFAS Is “Hazardous” Under RCRA

Plaintiffs in the ever-expanding PFAS litigation may attempt to introduce the EPA’s proposed classification of these nine PFAS as “hazardous” to improperly suggest to juries that PFAS poses human health hazards. PFAS defendants should be aware that these proposed rules have limited relevance to most if not all personal injury and consumer class action cases. For example, RCRA governs transport, disposal, and remediation of waste as opposed to products used by consumers. Moreover, classification as a “hazardous substance” under RCRA does not require proof that a substance more likely than not causes harm to human health and should not support causation. Defendants in PFAS lawsuits should consider taking affirmative measures to distinguish the terms used by the EPA and the duties imposed under RCRA from those allegedly at issue in the case, and emphasize that plaintiffs should be prevented from using them to improperly influence juries.

Our Mass Torts and Industry-Wide Litigation attorneys are following this issue and other important litigation matters throughout New York and the nation. Should you have questions on this or related matters, please contact Abbie Eliasberg Fuchs at (212) 313-5408 and afuchs@harrisbeach.com; Dan Strecker at (212) 912-3513 and dstrecker@harrisbeach.com; Alex Anolik at (212) 912-3502 and aanolik@harrisbeach.com; or the Harris Beach attorney with whom you most frequently work.

This alert is not a substitute for advice of counsel on specific legal issues.

Harris Beach has offices throughout New York state, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as Washington D.C., New Haven, Connecticut and Newark, New Jersey.