Explore our PFAS Regulatory Series

PFAS Regulatory Update: TSCA

Welcome to the fourth installment of the ELAM Group’s series exploring USEPA’s PFAS Strategic Roadmap, a comprehensive approach to address the challenges posed by the “forever chemicals,” also known as Per- and Polyfluoroalkyl Substances (PFAS). This roadmap focuses on three key objectives: Research, Restrict, and Remediate. Its goal is to deepen the comprehensive understanding of PFAS, limit their use and exposure, and tackle contamination in affected areas.

Our previous white papers provided foundational insights into the roadmap’s goals and initial impacts. Building on that groundwork, this series explores the roadmap’s impact on compliance with other environmental laws, including the Toxic Substances Control Act (TSCA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), and more.

In this installment, we examine the latest PFAS regulatory updates to the Toxic Substances Control Act (TSCA) and explain the broader implications for compliance, public health, and environmental protection.

What is the Toxic Substances Control Act (TSCA)?

The Toxic Substances Control Act (TSCA) was enacted in 1976, authorizing EPA to evaluate and regulate the production, importation, use, and disposal of specific chemicals in the United States. The TSCA addresses the identification and control of possible risks posed to human health and the environment before these toxic substances are produced in or transported into the U.S.

The total list of TSCA regulated chemicals is documented in the TSCA Chemical Substance Inventory.

The Role of TSCA in the PFAS Strategic Roadmap

As part of EPA’s 2021 PFAS Strategic Roadmap, the agency aims to use TSCA’s reporting mechanisms to collect essential PFAS data, a critical step in the roadmap’s research phase. Additionally, the roadmap directs the Office of Chemical Safety and Pollution Prevention to establish a robust review process under TSCA to ensure new PFAS are safe before entering commerce.

Alongside the 2021 Strategic Roadmap, EPA rolled out the National PFAS Testing Strategy, established to advance the agency’s understanding of PFAS chemicals’ environmental impact. Under TSCA, this testing strategy requires manufacturers to share key information regarding PFAS production and releases, helping to inform future regulatory efforts.

In September 2023, EPA finalized reporting requirements for PFAS manufactured or processed in the U.S. since 2011. With this rule, EPA added 41 compounds of concern, bringing the total number of reportable PFAS chemicals to at least 1,462.

These updates enable EPA to gather the largest-ever dataset of PFAS manufactured and used in the U.S., An estimated 130,000 U.S. companies (of which 97 percent are small businesses) will need to analyze whether this rule covers the products they manufacture or sell.

What’s New: Updates to the Final Rule and a Significant New Use Rule (SNUR)

On September 5, 2024, EPA issued a direct final rule to amend the TSCA regulation with reporting and record keeping requirements for PFAS.

Initially, businesses were required to report the use of these PFAS substances by May 2025. Small businesses, defined as those with total annual sales of less than $120MM, were given until November 2025. However, the TSCA program lacked the resources to launch the PFAS data portal on time. EPA has since extended the compliance period by about eight months, giving manufacturers until January 2026 and small businesses until July 2026 to submit final reports. This eases the burden on manufacturers of products and articles containing PFAS, allowing them more time to gather the 12 years of data requested.

In addition to the final rule, EPA updated a Significant New Use Rule (SNUR) that expands previous regulations of PFAS under the TSCA. This updated SNUR prohibits the manufacturing or processing of 329 PFAS chemicals listed as “inactive” on the TSCA inventory until they undergo review by EPA. Chemicals are classified as “inactive” if they have not been manufactured or processed in the U.S. since June 21, 2006.

Although listed as “inactive,” many PFAS chemicals have been used as binding agents, surfactants, and in making sealants and gaskets, with possible releases into the environment. To prevent further unreviewed use, the updated SNUR allows EPA to pause production until it evaluates whether the new use poses a risk to human health or the environment. Anyone planning to manufacture or process any of these 329 PFAS must now submit a Significant New Use Notice (SNUN) to EPA and comply with any resulting requirements.

Looking Ahead: PFAS Regulations into 2025

Through 2025, EPA will focus on gathering data from manufacturers and importers of PFAS chemicals, including information on production volumes, chemical composition, uses, potential health effects, and disposal methods under the TSCA. These reporting requirements are expected to inform future regulations.

In the coming months, businesses should evaluate whether they have reporting obligations under the SNUR or the updated final rule. Despite the extended deadline, manufacturers should take early action and practice due diligence to gather the required data.

The data collected through the final rule and SNUR review processes may lead to stricter PFAS regulations under the TSCA, potentially reducing their presence in manufactured goods.

 

If your organization has used PFAS, faces PFAS liability, or operates on property where PFAS may be present, it’s crucial to assess your compliance and potential risks. Contact The ELAM Group to learn more.