The U.S. Environmental Protection Agency (EPA) has refined the approval process for new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative, and toxic (PBT) chemicals. This move, announced on December 10, 2024, under the amendments to the Toxic Substances Control Act (TSCA), marks a critical step towards protecting public health and the environment.
Ensuring Safety Before Manufacturing
This new approval process will require that any new PFAS and PBT chemicals undergo a thorough safety review before entering the manufacturing phase. These substances, commonly found in a range of consumer, commercial, and industrial products—from adhesives and furniture coatings to firefighting foams—pose significant health risks. Exposure has been linked to various cancers, liver and heart impacts, and developmental damage in infants and children.
Key Changes in the Approval Process
Under the new rule, PFAS will no longer be eligible for low volume exemptions (LVE) or low release and exposure exemptions (LoREX). PBT chemicals will be excluded from these exemptions when environmental releases or potential unreasonable exposures are anticipated. Previously, chemicals with low production quantities or minimal environmental and human exposure underwent a shorter review. The new rule will require a comprehensive safety determination for 100% of new chemical submissions.
In April 2021, the EPA had already indicated that new PFAS would likely not qualify for previous exemptions due to their complex chemistry, potential health impacts, and persistence in the environment. With the 2016 TSCA amendments, formal safety determinations are now mandatory for all new chemical submissions, enhancing the agency’s ability to protect public health.
Additionally, the EPA’s final rule in April designated two widely used PFAS—perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)—as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. This ensures that the responsible parties pay for the cleanup of these contaminants, covering investigation, cleanup, and the reporting of leaks, spills, and other releases.
IFO Group’s TSCA Compliance Services
To assist companies in navigating these new regulations, IFO Group offers comprehensive TSCA Compliance Services. Our expert consultants specialize in ensuring compliance with TSCA Section 4 Test Orders, which require detailed monitoring of both users and non-users of specified chemicals. IFO Group is EPA GLP compliant, guaranteeing that their monitoring processes meet the highest standards of quality and reliability. IFO Group also helps organizations develop robust Workplace Chemical Protection Plans and navigate Existing Chemical Exposure Limits (ECELs). For more information on IFO Group’s TSCA Compliance Services, contact us at info@ifogroup.com or at 832-403-2135 to request a free consultation.
Review the finalized regulation amendments HERE.
