August 3, 2023

EPA Publishes Semiannual Agenda Previewing PFAS-Related Agency Actions

Holland & Knight Alert
Jose A. Almanzar | Amy L. Edwards | Dianne R. Phillips | Meaghan A. Colligan


  • The U.S. Environmental Protection Agency (EPA) on July 27, 2023, published its Semiannual Regulatory Agenda.
  • The Semiannual Regulatory Agenda includes proposed EPA actions under numerous federal environmental statutes, including the Clean Air Act (CAA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Toxic Substances Control Act (TSCA), Resource Conservation and Recovery Act (RCRA), Clean Water Act (CWA) and Safe Drinking Water Act (SDWA), among others.
  • Notably, EPA is expected to propose additional rules regulating per- and polyfluoroalkyl substances (PFAS), including its long-awaited national drinking water standards for two PFAS compounds.

The U.S. Environmental Protection Agency (EPA) on July 27, 2023, published its Semiannual Regulatory Agenda, which is intended to update the public about the agency's plan to review, propose and issue regulations over the coming months.

Overview of Proposed Actions

The following provides a general overview of some of EPA's proposed actions:

  • Under the Clean Air Act (CAA): EPA plans to revise state implementation plans (SIPs), delete the source categories list from the new source performance standards (NSPs) and propose area designations for air quality planning purposes, among other actions.
  • Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): EPA will take actions affecting the status of currently registered pesticides.
  • Under Toxic Substances Control Act (TSCA): EPA will propose licensing actions and new chemical actions.
  • Under the Resource Conservation and Recovery Act (RCRA): EPA plans to authorize certain state solid waste management plans and hazardous waste delisting petitions.
  • Under the Clean Water Act (CWA): EPA will review state water quality standards, make deletions from the Section 307(a) list of "toxic pollutants" and review delegations of National Pollutant Discharge Elimination System (NPDES) authority to states, among others.
  • Under the Safe Drinking Water Act (SDWA): EPA will take actions on state underground injection control programs.

Final PFAS Recording and Recordkeeping Requirements Under TSCA

EPA published a notice of proposed rulemaking on June 28, 2021, and a proposed rule on Nov. 25, 2022, addressing reporting and recordkeeping requirements (R&R Requirements) for PFAS under Section 8(a)(7) of TSCA. EPA's proposed rule would require all importers and manufacturers of PFAS since 2011 to report certain information to EPA related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure and disposal of the chemicals.

The public submitted to EPA more than 100 unique comments on the proposed PFAS R&R Requirements rule, including many suggesting that the proposed rule lacked sufficient data to support its estimates of burden and cost on small entities and PFAS importers. Based on these public comments, the agency convened a panel to research the economic impacts of the proposed PFAS R&R Requirements rule on small entities. The EPA panel also explored alternatives to the proposed R&R Requirements rule that may minimize significant economic impacts on small entities while accomplishing the agency's objectives.

As a result of the additional economic research conducted by EPA, the agency updated its estimate of costs for the proposed rule from $10.8 million to $875 million in social costs, as well as from $948,078 to $1.5 million in agency costs. EPA also estimated that affected small businesses subject to the PFAS R&R Requirements rule can expect to incur almost $900,000 in costs for the proposed one-time reporting. EPA noted in the Nov. 25, 2022, proposed rule that it was considering changes to the final rule from the regulatory proposal based on updates to the economic analysis. The comment period for the proposed PFAS R&R Requirements rule ended on Dec. 27, 2022.

In the Semiannual Regulatory Agenda, EPA notes that a final PFAS R&R Requirements rule under TSCA will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States. EPA anticipates issuing the final PFAS R&R Requirements regulations by September 2023.

Final PFAS National Drinking Water Regulations

EPA published a Regulatory Determination on March 3, 2021, indicating its intention to regulate two classes of PFAS – perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) – in drinking water. Under the SDWA, the publication of the Regulatory Determination required EPA to propose a maximum contaminant level goal (MCLG) and a national primary drinking water regulation (NPDWR) within 24 months of the determination and promulgate a NPDWR within 18 months after the proposal.

EPA proceeded to publish on Feb. 9, 2022, a notice of two virtual public meetings – one in March 2022, and the other in April 2022 – regarding the proposed PFAS drinking water regulations. EPA noted in the Feb. 9, 2022, notice that the public meetings were to include discussions and solicit input on environmental justice (EJ) considerations related to the proposed PFAS drinking water rule.

EPA also announced on June 15, 2022, interim updated drinking water health advisories for PFOA and PFOS that replaced those issued in 2016 by EPA under the SDWA and published in the Federal Register on June 21, 2022. EPA found the "updated advisory levels, which are based on new science and consider lifetime exposure, indicate that some negative health effects may occur with concentrations of PFOA or PFOS in water that are near zero and below EPA's ability to detect at this time." EPA also published new health advisories for two other PFAS compounds, "GenX" and perfluorobutane sulfonic acid (PFBS).

After receiving extensive public comments, EPA published on March 29, 2023, a proposed PFAS national drinking water regulation rulemaking. In this proposed rulemaking, EPA issued a preliminary regulatory determination to regulate six PFAS compounds under the SDWA. EPA also proposed for PFOA and PFOS individual MCGLs at zero and maximum contaminant levels (MCLs) of 4.0 nanograms per liter (ng/L) or parts per trillion (ppt). The comment period for the EPA's proposed PFAS drinking water regulations ended on May 30, 2023.

Next Steps

In the Semiannual Regulatory Agenda, EPA declares its intention to develop a final national primary drinking water regulation for PFOA and PFOS, and that the agency will continue considering drinking water limits for other PFAS. EPA also reiterates that the proposed final PFAS drinking water rules provide a key commitment in EPA's PFAS Strategic Roadmap: EPA's Commitments to Action 2021–2024. EPA anticipates promulgating a final rule setting MCLs for PFOA and PFOS by January 2024.

For more information or any questions about the regulations, please contact the authors or another member of Holland & Knight's Environmental Team.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.

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