Highlights
- In the first half of 2024, the U.S. Environmental Protection Agency (EPA) took steps toward implementing several regulatory commitments regarding per- and polyfluoroalkyl substances (PFAS) made in the 2021 PFAS Strategic Road Map.
- Notably, EPA designated two PFAS compounds as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which has broad implications on existing and future cleanup efforts and liability considerations.
- EPA issued regulations under the Safe Drinking Water Act that set legally enforceable thresholds for six PFAS in drinking water, including a Hazard Index to account for combined and co-occurring levels of these PFAS.
- Further, EPA finalized a new reporting requirement for the manufacture or importation of PFAS under Section 8 of the Toxic Substances Control Act.
Just past the halfway point of 2024, it's already been a busy year for those following regulatory developments related to per- and polyfluoroalkyl substances (PFAS). Building on its plans in the 2021 PFAS Strategic Road Map and its 2023 Second Annual Progress Report, the U.S. Environmental Protection Agency (EPA) continued its fast-paced regulatory activity in anticipation of the Congressional Review Act's look-back deadline, after which Congress has the right to review and potentially disapprove final regulations. In addition, rules previously promulgated by EPA require significant action in 2024. Summaries of key developments are below.
Resource Conservation and Recovery Act
EPA advanced efforts to address PFAS under the Resource Conservation and Recovery Act (RCRA) on Feb. 8, 2024, by proposing to add the following nine PFAS compounds, as well as their associated salts and structural isomers, to a list of hazardous constituents considered in the RCRA Corrective Action Program perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorobutanesulfonic acid (PFBS), hexafluoropropylene oxide-dimer acid (HFPO-DA or GenX), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), perfluorodecanoic acid (PFDA), perfluorohexanoic acid (PFHxA) and perfluorobutanoic acid (PFBA).
In addition, EPA proposed to expand the definition of hazardous waste applicable to regulatory corrective action to include not only listed chemicals, but also "any substance" that meets the broad statutory definition of "hazardous waste" under RCRA, which includes wastes that could "pose a substantial present or potential hazard to human health or the environment … ." EPA argues this change will allow the agency to enforce RCRA corrective action requirements as was intended in the law. Additionally, these revisions will grant the agency the authority to address PFAS and other emerging contaminants that have not yet been explicitly defined as hazardous waste at RCRA-permitted treatment, storage and disposal facilities. According to EPA's Spring 2024 Agency Rule List, EPA expects to finalize these rules in December 2024.
Safe Drinking Water Act
EPA announced the National Primary Drinking Water Regulation (NPDWR) under the Safe Drinking Water Act (SDWA) on April 10, 2024. The final rule sets legally enforceable thresholds, called Maximum Contaminant Levels (MCLs), for six PFAS in drinking water (PFOA, PFOS, PFHxS, PFNA and HFPO-DA as contaminants with individual MCLs and PFAS mixtures containing at least two or more of PFHxS, PFNA, HFPO-DA and PFBS using a Hazard Index MCL to account for the combined and co-occurring levels of these PFAS in drinking water.) EPA also finalized health-based, nonenforceable Maximum Contaminant Level Goals (MCLGs) for these PFAS.
Public water systems will have three years after the rule's promulgation to comply with monitoring requirements, i.e., by December 2026, at which point they must begin reporting their monitoring results. The initial monitoring requirements will mandate four quarterly samples for larger systems serving populations of more than 10,000 people and biannual samples from smaller systems serving populations of 10,000 or fewer. Beginning five years after promulgation, if the levels of PFAS detected in these samples exceed the MCLs, public water systems must notify their served communities and take steps to reduce levels of PFAS in their drinking water. States will be permitted to set and enforce their own drinking water criteria, provided the criteria are at least as stringent as the EPA's national criteria.
Over the last few years, multiple states – Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Washington and Wisconsin – established enforceable drinking water standards for certain PFAS in drinking water under state law. Several states, including Delaware and Virginia, are also considering MCLs for certain PFAS. Other states, such as Connecticut, Maryland and Oregon, have established nonenforceable "action levels" or drinking water guidelines. Some states, such as California and Utah, have begun monitoring programs in addition to EPA's Unregulated Contaminant Monitoring Rule. All of this adds greater complexity to drinking water standards and creates confusion for consumers and regulated entities.
Two organizations filed a petition on June 7, 2024, challenging the NPDWR under the SDWA in the U.S. Court of Appeals for the District of Columbia Circuit in Docket No. 24-1188. On June 10, 2024, more organizations filed similar petitions in the same court as Docket No. 24-1191 and Docket No. 24-1192. All three cases have been consolidated under Docket No. 24-1188. Several additional parties have moved to intervene. Procedural motions were due in mid-July. According to one party's Nonbinding Statement of Issues, several of the challenges relate to use of the Hazard Index MCL, the regulation of mixtures and the feasibility of achieving the MCLs, among other things.
Collectively, the parties argued that the NPDWR is arbitrary and capricious and should be overturned, contending that the agency exceeded its authority under the SDWA and did not follow the mandate by Congress. These challenges have been filed sufficiently recently that the petitioners are likely (and are expected to be able) to use the U.S. Supreme Court's June 28, 2024, decision overruling the Chevron doctrine in Loper Bright Enterprises v. Raimondo (Loper). In addition, petitioners are expected to rely on the 2022 Supreme Court decision in West Virginia v. EPA (West Virginia) to bolster their argument that the EPA lacked the authority under the SDWA to promulgate the NPDWR. In West Virginia, the Supreme Court set out the "major questions" doctrine – a rule of statutory construction that holds if an agency seeks to decide an issue of major national significance, its action must be supported by clear congressional authorization. Pursuant to that rule of construction, the organizations are anticipated to argue EPA would be precluded from issuing the NPDWR absent clear congressional authorization to EPA to regulate PFAS.
Comprehensive Environmental Response, Compensation, and Liability Act
EPA announced on April 19, 2024, its final rule designating two PFAS compounds – PFOA and PFOS, including their salts and structural isomers – as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). The rule was published in the Federal Register on May 8, 2024, with an effective date of July 8, 2024. The following obligations and ramifications are implicated:
- PFOA and PFOS releases of one pound or more in a 24-hour period must be reported to the National Response Center (NRC).
- EPA may include an evaluation of PFOA and PFOS in its five-year review of sites included on the National Priority List (Superfund sites).
- EPA may order investigations and cleanups of PFOA and PFOS and recover such costs from responsible parties.
- Private parties that conduct cleanups consistent with the National Contingency Plan may seek to recover cleanup costs associated with PFOA and PFOS from other responsible parties, including contribution for costs paid.
- Federal entities that transfer or sell property must provide notice about the storage, release or disposal of PFOA or PFOS on the property, as well as guarantee that any PFOA or PFOS contamination has been remediated or, if needed, that additional cleanup will occur in the future.
- Compliance with the "All Appropriate Inquiries" rule, 40 C.F.R. Part 312, will require consideration of PFOA and/or PFOS to qualify for CERCLA Landowner Liability Protections.
Three organizations filed a petition on June 10, 2024, challenging the CERCLA designation, arguing EPA exceeded its statutory authority under the Administrative Procedure Act in the U.S. Court of Appeals for the District of Columbia Circuit in Docket No. 24-1193. Several parties have moved to intervene in support of EPA. Procedural motions are due in July 2024.
Toxic Substances Control Act
EPA published a final rule in October 2023 to amend Section 8 reporting requirements under the Toxic Substances Control Act (TSCA) that require persons who manufacture (including import) or have manufactured or imported these chemical substances or products containing these substances, in any year between Jan. 1, 2011, and Dec. 31, 2022, to report information electronically regarding PFAS uses, production volumes, disposal, exposures and hazards. The new regulations, 40 C.F.R. Part 705, which became effective on Nov. 13, 2023, have enormous implications.
The rule applies not only to traditional chemical manufacturers, but to all importers of products (Product Importers) that may contain one or more PFAS compounds. PFAS are used in a large number of product categories, such as electronics, wires and cables, pipes, cooking and bakeware, textiles, automotive applications, toys, water- and stain- resistant clothing, cleaning supplies, dental floss, toilet paper, paints, varnishes, carpets, and many other industrial and consumer products, so the potential universe of regulated parties is vast. There are no exemptions for low levels or small amounts of PFAS use. Exemptions are provided for PFAS used in certain types of products regulated by other agencies and programs, such as food additives and medical devices. For many Product Importers, this will be an entirely new process giving rise to many questions, some of which are answered in EPA's recently published Frequently Asked Questions (May 2024) and Instructions for Reporting PFAS Under TSCA Section 8(a)(7) (May 2024). Reporting on a compound-by-compound basis is due May 8, 2025 (or Nov. 10, 2025 for small entities).
Toxics Release Inventory
EPA published a final rule changing reporting requirements for PFAS listed in the Toxics Release Inventory (TRI) on Oct. 31, 2023. The final rule includes PFAS currently on the TRI and automatically includes additional PFAS added pursuant to sections 7231(b) and (c) of the 2020 National Defense Authorization Act to the list of chemicals of special concern eliminates the de minimis exemption for "Supplier Notification Requirements" for all chemicals of special concern and limits the use of range reporting. EPA contends that elimination of the de minimis exemption and range reporting options will provide a more complete picture of PFAS releases and waste management quantities. As described by EPA, some requirements become effective for reporting year 2023 (forms were due by July 1, 2024, for 189 PFAS compounds), but the most significant changes will be implemented in reporting year 2024 (forms due July 1, 2025, for 196 PFAS compounds).
National Pollutant Discharge Elimination System
Currently the NPDWR, if upheld, will also impact the development of effluent limits for National Pollutant Discharge Elimination System (NPDES) permits that regulate point source discharges to waterbodies under the Clean Water Act. When developing effluent limits for an NPDES permit, discharge limits must protect the uses of the receiving waterbody. If the receiving waterbody is a drinking water source, the MCLs from the Drinking Water Rule will influence the derivation of human health-based water quality criteria and related permit effluent limits. EPA has not promulgated any binding changes to the NPDES permitting programs as of now, but guidance was issued for state environmental agencies and NDPES permit issuers that recommends adopting the full suite of PFAS monitoring techniques being used by EPA. According to EPA's Spring 2024 Agency Rule List, EPA expects to issue a proposed rule in June 2025 to update NPDES application regulations, 40 C.F.R. 122.21.
In a similar vein, EPA has not yet released actionable Effluent Limitation Guidelines (ELGs) to restrict PFAS discharges. In the Strategic Roadmap, EPA predicted that the agency will make "significant" ELG regulatory changes by the end of 2024. According to its Spring 2024 Agency Rule List, EPA expects to issue a proposed rule (ELG) revising the existing Organic Chemicals, Plastics, and Synthetic Fibers ELG (40 CFR Part 414) by September 2024. Currently, EPA is continuing its multi-industry study of PFAS discharges and utilizing the ELG program to conduct industry-specific studies, as described in Effluent Guidelines Program Plan 15 ( Plan 15). Specifically, EPA is evaluating the textiles industry (40 CFR part 410), concentrated animal feeding operations (40 CFR part 412) and nationwide data on industrial discharges of PFAS to publicly owned treatment works. To date, through Plan 15, EPA has determined that revisions to the effluent guidelines and standards for landfills (40 CFR part 445) are warranted and will not be pursuing further action regarding the electrical and electronic components industry (40 CFR part 469). However, EPA will continue to monitor PFAS discharges from the electrical and electronic components industry, pulp, paper and paperboard category (40 CFR part 430) and airports. EPA also intends to propose updates to its Clean Water Act Part 136 monitoring methods to incorporate multilaboratory-validated methods for analyzing PFAS in January 2025.
Conclusion
In summary, there is a lot going on in the PFAS regulatory world, and it takes a scorecard to keep track of proposed, finalized and challenged regulations. EPA does not appear to be letting up, and further developments are expected throughout 2024 and into early 2025.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.