USA Regulatory News

On October 7, 2025, the U.S. Environmental Protection Agency (EPA) announced the automatic addition of sodium perfluorohexanesulfonate (PFHxS-Na) (CAS No. 82382-12-5) to the Toxics Release Inventory (TRI).  

This action, mandated under the Fiscal Year 2020 National Defense Authorization Act (NDAA), follows EPA’s finalization of the “IRIS Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS, CAS No. 335-46-4) and Related Salts.”  

With this addition, 206 PFAS are now subject to TRI reporting, effective January 1, 2026.  

Reporting Scope and Requirements 

Facilities in designated industries that manufacture, process, or otherwise use TRI-listed chemicals must report annual data on the quantities released or managed as waste.  

Starting January 1, 2026, facilities handling PFHxS-Na must track and report their activities as required under section 313 of the Emergency Planning and Community Right-to-Know Act.  

This addition supports EPA’s ongoing efforts to enhance transparency and public access to data on per-and polyfluoroalkyl substances (PFAS) in the environment and provides valuable information for both communities and policymakers

On September 17, 2025, the U.S. Environmental Protection Agency (EPA) has released a draft risk evaluation for Octamethylcyclotetrasiloxane (D4) under the Toxic Substances Control Act (TSCA). The agency’s initial findings indicate that D4 may pose unreasonable risks to human health and the environment under certain conditions of use. 

Key Findings: Risks to Human Health 

EPA identified 23 conditions of use (COUs) where workers face potential risks, particularly during the manufacture of D4 and in processing activities involving adhesives, sealants, paints, and coatings. In addition, one consumer COU involving D4 in paints and coatings was flagged for unreasonable risk. 

The draft evaluation clarifies that these determinations do not assume the use of personal protective equipment (PPE). While PPE may reduce exposure, EPA emphasizes that risk exists without its consistent use. Importantly, no unreasonable risks were identified for the general population. 

Key Findings: Environmental Risks 

EPA’s draft evaluation also highlights seven COUs where D4 could pose risk to the environment. For another 18 environmental COUs and two human health COUs, the agency has not yet reached preliminary conclusions. 

Scientific Insights 

The draft incorporates recent studies on bioaccumulation and biomagnification of D4. Studies show D4 can accumulate in aquatic organisms but has a low likelihood of biomagnifying through the food chain, as fish are able to metabolize ingested D4. These findings suggest that while exposure occurs, accumulation across trophic levels may be limited. 

Public Comment and Review 

EPA is inviting public comments until November 17, 2025, through docket EPA-HQ-OPPT-2018-0443 on Regulations.gov. 

Two public meetings are planned: 

• Preparatory meeting – November 18, 2025 
• Peer review meeting – December 2–5, 2025, led by the Science Advisory Committee on Chemicals (SACC) 

Participants may submit written feedback or request to present oral comments by the deadlines listed on the SACC website. 

Next Steps 

Following the comment period and peer review, EPA will finalize the risk evaluation. If unreasonable risks are confirmed, the agency may propose risk management actions to reduce exposure to D4 in workplaces, consumer settings, and the environment. 

The U.S. Environmental Protection Agency (EPA) has issued Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were subjected to Premanufacture Notices (PMNs) or a Microbial Commercial Activity Notice (MCAN) and are also subjected to an EPA-issued Order under TSCA. 

Notification Requirement 

Companies must notify EPA at least 90 days before starting manufacture (including import) or processing of these substances for any designated significant new use. Manufacture or processing for the new use cannot begin until: 

Effective Dates 

The rule will take effect on September 29, 2025, and official announcement for judicial review took place on August 12, 2025, at 1 p.m. EST.