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The Takeaway

As the clock wound down on the Biden Administration, USEPA did not break for the holidays. Instead, in December 2024 and January 2025, it issued a flurry of updates related to per- and polyfluoroalkyl substances (PFAS).

USEPA’s actions will result in the gathering of additional publicly available information and data. Plaintiff lawyers are closely monitoring these actions and the data it generates to support personal injury, property, and other types of claims. At the same time, regulated entities are closely monitoring any regulatory changes that may result from the transition to the Trump Administration.

IRIS Toxicity Assessment

On January 13, 2025, USEPA released its final Integrated Risk Information System (IRIS) toxicity assessment for perfluorohexanesulfonic acid (PFHxS) and its related salts.[1] IRIS toxicity assessments review available evidence and data on potential human health effects that may result from exposure to the chemical assessed. USEPA, state environmental agencies, and health agencies can use the assessment as a basis for taking certain actions.

Like other PFAS, PFHxS is used in consumer products such as water- and stain-protective coatings for carpets, textiles, paper and packaging (including those that contact food), and electronics. In the industrial setting, PFHxS may be present as a surfactant to make fluoropolymers, as a surfactant or surface protection agent for cleaning and polishing products, and in other industrial fluids or water-proofing agents. The toxicity assessment for PFHxS is one in a series of five PFAS assessments that the IRIS Program is developing as part of USEPA’s PFAS Strategic Roadmap.

The risk assessment finalized for PFHxS retains the proposed risk values and findings that if given sufficient exposure conditions, PFHxS is likely to adversely affect the human thyroid and cause developmental immune impacts. The primary supporting evidence for thyroid effects includes decreased thyroid hormone levels, abnormal histopathology results, and changes to organic weight in experimental animals. The primary supporting evidence for immune effects includes decreased antibody responses to tetanus and diphtheria vaccinations in children.

Toxics Release Inventory

On January 3, 2025, USEPA announced the addition of nine PFAS to the list of chemicals under the Toxics Release Inventory (TRI) program.[2] The TRI program tracks releases and management of toxic chemicals that may pose a threat to human health and the environment. USEPA gathers this data via TRI’s reporting obligations, under which subject facilities must submit a toxic chemical release form annually. In December 2019, Congress passed the National Defense Authorization Act for Fiscal Year 2020, which added 172 PFAS to the list of TRI chemicals. The Act also included a process for automatically adding additional PFAS to the TRI list when certain events occur.

In October 2023, USEPA finalized a rule that categorized PFAS on the TRI list as “chemicals of special concern.” Chemicals of special concern have a lower reporting threshold of 100 lbs. Previously, PFAS on the list were not subject to the same reporting limitations as other chemicals of special concern. These limitations include removal of the de minimis exemption, which allows facilities to not take into consideration small concentrations of TRI chemicals. In October 2024, USEPA proposed adding 16 individual PFAS and 15 PFAS categories to the TRI list. 89 Fed. Reg. 81776 (Oct. 8, 2024).

PFAS compounds recently added to the TRI list are used in a variety of products, including components of adhesives, coatings, and cleaning products. These PFAS were added to the TRI list due to finalization of toxicity values for them during 2024. The addition of these nine PFAS brings the total PFAS on the TRI list to 205 for TRI Reporting Year 2025 (to be reported by July 1, 2026).

NOTE: As with other PFAS reporting obligations, companies should ensure they have robust internal procedures in place to comprehensively capture the data that’s required to be reported.

Human Health Water Quality Criteria

On December 26, 2024, USEPA published a notice in the Federal Register of a draft National Recommended Ambient Water Quality Criteria for the Protection of Human Health for three PFAS (PFOA, PFOS, and PFBS). 89 Fed. Reg. 105041 (Dec. 26, 2024). The draft was noticed for a 60-day public comment period. The Clean Water Act requires USEPA to develop and revise criteria for protection of human health and water quality that accurately reflects the latest scientific knowledge. Human health criteria are to be based on data and scientific judgment regarding the pollutant concentrations’ impact on human health. Neither economic impact nor technological feasibility of meeting the pollutant concentrations are considered when developing human health criteria.

The draft recommended human health criteria (HHC) for the three PFAS published in December 2024 are:

The purpose of developing human health criteria is to minimize the risk of adverse effects to humans from lifetime exposure to certain substances through drinking water and eating fish and shellfish. The human health criteria are not enforceable and cannot be alleged as violations. They may, however, be used by states when developing enforceable water quality standards. The draft human health criteria for PFAS follows USEPA’s finalization of the national recommended aquatic life criteria for PFOA and PFOS in September 2024. The comment period is set to close on February 24, 2025; however, it is likely that the new administration will extend this comment period.

NPDES Multi-Sector General Permit for Stormwater Discharges from Industrial Activity

Also in December 2024, USEPA released its proposed 2026 National Pollutant Discharge Elimination System (NPDES) Multi-Sector General Permit for Stormwater Discharges from Industrial Activity.[3] Notice of the proposed permit was published in the Federal Register on December 13, 2024. 89 Fed. Reg. 101000 (Dec. 13, 2024).

The proposed Multi-Sector General Permit is a collection of 50 General NPDES Permits that covers industrial facilities in 29 industrial sectors. The Multi-Sector General Permit for Stormwater Discharges covers discharges of stormwater from industrial areas where USEPA is the NPDES permitting authority. Upon finalization, the proposed 2026 Multi-Sector General Permit will replace the Multi-Sector General Permit issued in 2021 that will expire on February 28, 2026. While the recently proposed 2026 Multi-Sector General Permit only covers areas where USEPA is the permitting authority, these General Permits often dictate what USEPA will look for in the issuance of NPDES permits where states are the permitting authority.

The proposed 2026 Multi-Sector General Permit includes several significant changes. Among these proposed changes is a new provision that would require certain operators to conduct quarterly monitoring for PFAS. The monitoring would apply to 40 PFAS compounds, and EPA Method 1633 must be used for analyzing samples. For the industry sectors subject to the monitoring, the quarterly monitoring begins the first full quarter of permit coverage and would be “report-only” indicator analytical monitoring. “Report-only” monitoring does not have a threshold or value for comparison and does not require follow-up actions based on the results of the monitoring (other than the duty to comply with applicable water quality standards). The public comment period on the draft permit was originally set to close on February 11, 2025. However, on February 3, 2025, the new administration extended the comment period until April 4, 2025. 90 Fed. Reg. 8798 (Feb. 3, 2025).

[1] The final toxicity assessment for PFHxS is at https://iris.epa.gov/ChemicalLanding/&substance_nmbr=705. Last visited 2/11/25.

[2] USEPA’s News Release is at https://www.epa.gov/newsreleases/epa-adds-nine-additional-pfas-toxics-release-inventory#:~:text=WASHINGTON%20%E2%80%94%20Today%2C%20Jan.,by%20the%20Toxics%20Release%20Inventory. Last visited 2/11/25

[3] The draft permit is at https://www.epa.gov/npdes/stormwater-discharges-industrial-activities-epas-proposed-2026-msgp. Last visited 2/11/25.