Overview of Pfas Regulations in the United States and What Foreign Companies and Their U.s. Subsidiaries Need to Know—part Ii

• Citation: Vol. 2 No. 4
• Publication year: 2024

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Reza Zarghamee, Shinya Akiyama, and Lauren Johnstone ^*

This two-part article overviews the status of poly- and perfluoroalkyl substances (PFAS) regulation in the United States. The first part, published in the prior issue of The Journal of Federal Agency Action, described PFAS, the types of products that include it, and the recent wave of litigation involving PFAS contamination, which has involved settlements above $10 billion. The conclusion of this article, published here, discusses developments in federal and state regulation of these chemicals. A brief discussion of specific scenarios in which these developments may affect foreign corporations follows. This part then ends by recommending that businesses that manufacture, distribute, use, or dispose of PFAS or products containing PFAS stay abreast of these developments and develop proactive strategies to minimize their potential liability.

Federal Regulatory Developments

The U.S. Environmental Protection Agency (EPA) and the federal government have taken incremental steps to regulate poly- and perfluoroalkyl substances (PFAS) since the early 2000s. For example, in 2002, the EPA initiated a phaseout of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) by major domestic manufacturers, but no recall of products. ¹ This was followed in 2006 by a PFOA Stewardship Program, which secured commitments from eight major manufacturers and users of the chemical to manage and dispose of their product stocks. ² Since the early 2000s, the EPA has promulgated regulations either creating or clarifying the need to submit notifications—Pre-Manufacture Notifications (PMNs) and Significant New Use Notifications (SNUNs)—to the EPA under Section 5 of the Toxic Substances

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Control Act (TSCA) before the marketing and commercial distribution of certain PFAS-containing products. ³

In September 2021, under the Biden administration, the EPA published its PFAS Strategic Roadmap, which delineated the actions that the EPA planned to take in the short- and long-term to address PFAS. ⁴ Among other things, the Roadmap calls for the significant expansion of PFAS regulation above and beyond just PFOA and PFOS. ⁵ In addition, the Roadmap calls for the refinement of analytical techniques for sampling and identifying PFAS and further research into feasible remedial technologies. Notable regulatory efforts undertaken pursuant to the Roadmap include, without limitation:

■ Listing PFAS as "Hazardous Substances" Under the Comprehensive Environmental Response, Compensation, and LLiability Act (CERCLA) ⁶ In August 2022, the EPA proposed listing PFOA and PFOS and their salts and isomers as CERCLA "hazardous substances." Subsequently, in April 2023, the EPA issued an advance notice of proposed rule-making to list seven additional PFAS:

1. Perfluorobutanesulfonic acid,
2. Perfluorohexanesulfonic acid,
3. Perfluorononanoic acid,
4. Hexafluoropropylene oxide dimer acid (sometimes called GenX),
5. Perfluorobutanoic acid,
6. Perfluorohexanoic acid, and
7. Perfluorodecanoic acid.

Once finalized, these proposed listings will bring sites contaminated with the pertinent PFAS under the scope of CERCLA, the primary federal environmental remediation statute. It stands to impose joint and several liability on past and present owners and operators of properties contaminated with these substances, as well as on transporters and parties that arrange for the disposal of these ubiquitous chemicals. Thus, entities with no operational nexus to PFAS, may walk into PFAS-related liabilities merely based on holding a real estate interest in a contaminated property. Furthermore, given that CERCLA is the model for most state environmental cleanup statutes, the expectation is that the states, too, would list these substances in

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their analogous laws once the EPA has added them to the "hazardous substances" list. CERCLA listing will provide another statutory basis for private party litigation, as Sections 107 and 113 authorize potentially responsible parties to bring suit against one another to recover response costs. Expanding the list of hazardous substances will create an impetus for regulators to require sampling for these potential contaminants at sites where remediation is underway or not yet completed. It may also serve to "reopen" investigations at sites where remediation had been completed and compel responsible parties to incur costs for which they have not yet planned.

■ EEstablishing an Enforceable Maximum Contaminant Limit (MCL) for Six PFAS Under the Safe Drinking Water Act ⁷ This measure will have a twofold impact.

First, it will establish an enforceable federal limit for these PFAS, such that regulated public water systems will incur liability in the form of penalties and injunctions for exceeding them. This, in turn, will precipitate lawsuits against the violating utilities by customer, as well as by the utilities against the parties responsible for contaminating the water supply.
Second, because MCLs inform environmental remediation efforts, the codification of an MCL will establish a de facto remediation target for the six PFAS in ground-water. In this connection, it is relevant that the EPA has proposed, as an MCL, four parts per trillion for PFOA and PFOS. This standard is orders of magnitude lower than the cleanup levels for most other deleterious contaminants, such as volatile organic compounds, and many in the regulated industry conclude it is predicated on an overly conservative interpretation of toxicity data. The Proposed Rule was issued March 2023. ⁸ Coupled with the broad sweep of CERCLA liability, this proposed regulation stands to greatly increase the costs and duration of PFAS-related remediation projects.

■ One-Time PFAS Reporting Rule Under TSCA Section 8(a)(7). In late September 2023, the EPA issued a pre-publication of a final rule ⁹ that would require businesses to provide information to the agency regarding their manufacture or importation of PFAS since 2011. The reporting deadline is

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October 11, 2025. The information that must be reported is largely similar to that which is required to be submitted every four years under the TSCA Chemical Data Reporting (CDR) rule. However, the one-time PFAS reporting rule does not contain many of the exemptions that apply to CDR. Not only is there no weight-based reporting threshold, but the EPA has chosen not to allow the article exemption. As a result, in addition to manufacturers and importers of bulk chemicals, businesses that import articles, or manufacture them in a way that forms new PFAS (e.g., through heat treatment), will have to obtain information from entities that are upstream in the supply chain. This may be particularly difficult in the case of articles, as unlike bulk chemicals and mixtures, manufactured parts and complete products typically are not distributed in commerce with Safety Data Sheets or specifications that enumerate all the chemicals present within them. Aside from facilitating EPA efforts to prioritize specific PFAS for further investigation and restrictions, the information that the EPA receives will assist federal and state agencies in prioritizing specific operations for potential investigations and enforcement. Moreover, pursuant to the Freedom of Information Act, such information stands to be made available to the public, including environmental and consumer advocacy groups and plaintiffs' firms. Such groups, as well as governmental agencies, may have a vested interest in tying certain businesses to known areas of PFAS contamination.

In total, the measures specified in the PFAS Strategic Roadmap and issued in the proposed rules stand to regulate PFAS' introduction into commerce, use, and remediation. Over two dozen congressional bills are pending that require implementation of the PFAS Strategic Roadmap or otherwise touch on PFAS.

State Regulatory Developments

Numerous states also have undertaken legislative and regulatory actions to address PFAS, with dozens of bills introduced and enacted throughout the country. Besides continuing to initiate lawsuits against businesses believed to have contributed to PFAS

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contamination, states currently are implementing three broad categories of actions to address PFAS:

1. Drinking Water and Groundwater Cleanup Standards. To date, many states have issued guidance or regulations establishing drinking water or groundwater remediation standards for PFAS. ¹⁰ These standards span a wide range of numerical limits, which reflect the fluid state of information and diversity of opinion regarding the consequences of PFAS exposure.
2. Commercial Regulation of PFAS-Containing Products. In this connection, a number of states have codified laws requiring business entities such as manufacturers, packagers, importers, suppliers, and distributors of PFAS-containing products to provide

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