The Environmental Protection Agency’s (EPA) recent rulemakings for per- and polyfluoroalkyl substances (PFAS) have far-reaching implications for a broad range of industries, regulated entities, and regulatory bodies. First, on April 8, 2024, EPA issued the nation’s first enforceable drinking water standard concerning PFAS, marking a pivotal step in EPA’s long-announced plan to address the pervasive presence of these persistent chemicals in water sources around the country. Second, on April 19, 2024, EPA took further action by designating two PFAS compounds as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or Superfund. These developments demonstrate the Biden Administration’s commitment to take action on PFAS and underscore the need for the regulated community to take corresponding action to ensure compliance and mitigate potential liabilities.
PFAS Drinking Water Standard
On April 8, 2024, EPA announced the first enforceable drinking water standard for PFAS, the final National Primary Drinking Water Regulations, 40 C.F.R. § 141 , and National Primary Drinking Water Regulations Implementation, 40 C.F.R. § 142 (collectively, NPDWR or PFAS Drinking Water Rule), responding to mounting concerns regarding the widespread presence of these “forever chemicals” and potential health implications. The PFAS Drinking Water Rule is a significant development for public water systems in particular, although it will also have indirect impacts on state and local governments. Public water systems are required to determine whether PFAS is in their drinking water and, if so, are mandated to take actions such as notifying consumers and reducing the levels of PFAS, as needed.
By establishing legally enforceable health-protective levels for certain PFAS in drinking water under its authority under the Safe Drinking Water Act, EPA asserts that the PFAS Drinking Water Rule “will significantly reduce the level of PFAS in drinking water across the United States,” reducing PFAS exposure for approximately 100 million people. Critics say the regulations could put significant financial burdens on water utility ratepayers, which could have disparate impacts on disadvantaged communities. Others criticize the discrepancies between various state regulations and the PFAS Drinking Water Rule, and note the current best available technologies may not remove PFAS sufficiently to achieve the PFAS Drinking Water Rule’s required levels.
The NPDWR establishes enforceable Maximum Contaminant Levels (MCLs) for six PFAS known to occur individually and/or as mixtures in drinking water, as well as non-enforceable health-based goals. Mixtures of four PFAS (PFHxS, PFNA, HFPO-DA, and PFBS) are also regulated through a Hazard Index (HI).
- Enforceable levels: The MCLs are 4 parts per trillion (ppt) for PFOA and PFOS and 10 ppt for PFNA, PFHxS, and HFPO-DA (GenX Chemicals). The MCL Hazard Index is 1.
- Non-enforceable health-based goal: This standard is called the Maximum Contaminant Level Goal (MCLG). The MCLG for PFOA and PFOS is zero and for PFNA, PFHxS, and HFPO-DA (GenX Chemicals) is 10 ppt. The MCLG Hazard Index is 1.
The PFAS Drinking Water Rule applies to public water systems involved in the management and distribution of drinking water. Public water systems must complete initial water monitoring for PFAS within three years of the PFAS Drinking Water Rule’s promulgation (by 2027). Within three years following rule promulgation (2027 – 2029), public water systems must include results of initial monitoring in Consumer Confidence Reports (i.e., an annual water quality report ), begin monitoring for compliance and report compliance monitoring results in Consumer Confidence Reports, and notify the public of monitoring and testing violations. Five years after rule promulgation (2029 onward), public water systems must comply with MCLs and notify the public of MCL violations.
Prior to promulgation of EPA’s PFAS Drinking Water Rule, approximately half (23) of the states had adopted their own PFAS regulations. The state-level regulatory landscape for PFAS varies widely, though. For example, allowable concentrations of PFAS in drinking water range from 2 ppt (Illinois) to 400,000 ppt (Michigan). These variations can be explained by the specific PFAS compounds present, the stage of the regulatory process, and each state’s assessment of the levels that may pose health risks. A nationwide standard will provide clarity and ensure consistency for public water systems throughout the country.
PFAS Listed as Hazardous Substances
On April 19, 2024, EPA issued the final rule designating two common PFAS compounds as hazardous substances (PFAS Hazardous Substances Designation) (EPA, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, Pre-Publication Version (April 19, 2024)). The rule will be effective 60 days after publication in the Federal Register. The same day, EPA issued the PFAS Enforcement Discretion and Settlement Policy Under CERCLA.
The designation of two PFAS compounds as hazardous substances carries significant implications for the management and remediation of PFAS-contaminated sites. By classifying these compounds as hazardous substances under CERCLA, EPA has expanded its authority to address PFAS contamination more comprehensively, enabling the agency to allocate resources for cleanup efforts and hold responsible parties accountable for remediation costs. This designation also enhances EPA’s ability to pursue legal actions against parties deemed liable for PFAS releases, thereby heightening regulatory scrutiny on industries and entities associated with PFAS usage and disposal. EPA could also reopen previously closed Superfund sites to require potentially responsible parties (PRPs) to clean up PFOS and PFOA contamination, or implement additional remediation requirements for existing sites undergoing cleanup, causing significant uncertainty for owners of current or prior contaminated sites.
EPA’s PFAS Enforcement Discretion and Settlement Policy Under CERCLA describes EPA’s intent to focus enforcement on major contributors to PFAS contamination, such as manufacturers and industrial users. Citing “equitable factors,” the policy states that EPA does not plan to initiate CERCLA enforcement actions against specific groups of PRPs, including community water systems and publicly owned treatment works, municipal separate storm sewer systems, publicly owned/operated municipal solid waste landfills, publicly owned airports and local fire departments, and farms where biosolids are applied to the land. For these parties, EPA can enter settlements to provide contribution protection against third-party claims. For other PRPs, EPA will consider the following factors in applying its enforcement discretion: (1) whether the entity is a state, local, or Tribal government, or does work that would be done by such a governing body; (2) whether the entity provides a public service in various sectors, including drinking water, waste, wastewater, and fire suppression; (3) whether the entity manufactured PFAS or used PFAS as part of an industrial process; and (4) whether, and to what degree, the entity is actively involved in the use, storage, treatment, transport, or disposal of PFAS.
Litigation
PFAS-related litigation is ongoing across the country—independent of and in addition to the recent rulemaking. To date, this litigation has mostly been focused on suits brought by individuals and local governments against PFAS manufacturers, manufacturers of PFAS-containing products, and the United States Air Force.1 Newer lawsuits are emerging against food packaging manufacturers and cosmetics companies.2 Attorneys general in 27 states have brought PFAS-related cases, including 13 in 2023 alone, representing a dramatic acceleration in state litigation related to PFAS. Currently, there is no pending litigation to stay the effect of either of these final rules. The PFAS Drinking Water Rule was published in the Federal Register on April 26, 2024, while the PFAS Hazardous Substances Designation awaits official publication. Legal challenges concerning both regulations are anticipated in the future.
WilmerHale’s Energy, Environment and Natural Resources team will continue to monitor PFAS-related developments.
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