US EPA Proposes Amendments to PFAS Reporting Regulations Under TSCA to Reduce Compliance Burdens

Summary of the Proposed Amendments

The EPA intends to maintain reporting for significant PFAS activities but revise several elements to make the program more practical. The proposal responds to industry criticism that the previous Biden Administration rule was overly burdensome and lacked clear data-use guidance.

Key points include:

• Introduction of exemptions for specific PFAS categories.
• Technical corrections to clarify reporting data fields.
• Adjustments to the reporting submission timeframe.
• A defined public comment period of 45 days.

Explanation of Proposed Changes

The proposal introduces exemptions for PFAS found in:

• Mixtures or products at concentrations of 0.1 percent or lower. 
• Imported articles, including components containing PFAS.
• Certain byproducts, impurities, research and development chemicals, y non-isolated intermediates. 

The EPA also plans to:

• Implement technical corrections to data fields for clarity.
• Modify the submission period to improve the ease of reporting.
• Retain reporting obligations for all manufacturers and importers active from 2011–2022. 

Compliance and Industry Impact

According to EPA’s assessment, the amendments are expected to:

• Reduce overall compliance costs for regulated businesses.
• Provide greater regulatory certainty for manufacturers and importers.
• Relieve companies from reporting information that is likely unavailable.
• Maintain EPA access to the most relevant PFAS data for regulatory oversight.
• Support balanced regulatory implementation under TSCA section 8(a)(7). 

Fecha límite para comentarios

• The 45-day public comment period begins upon publication in the Registro Federal.
• Stakeholders must reference docket EPA-HQ-OPPT-2020-0549 when submitting feedback.

Por qué es importante

These revisions are designed to:

• Improve clarity around PFAS applicability thresholds.
• Streamline reporting obligations without compromising data quality.
• Reduce administrative burdens for companies handling trace PFAS.
• Increase alignment between regulatory expectations and operational feasibility.

Para quién es relevante esta actualización

The amendments directly affect:

• Manufacturers and importers handling PFAS between 2011–2022.
• Companies importing or using raw materials, articles, o components that may contain trace PFAS.
• Sectors such as chemicals, general CPG, and life sciences with U.S. operations.
• Organizations working with CMOs or CDMOs, where indirect PFAS exposure may exist.

Indirect but relevant considerations include:

• Verification of PFAS levels in process equipment, container/closure systems, and excipient supply chains.
• Supply chain mapping to confirm whether exemptions apply to any third-party partners.

Próximos pasos

Stakeholders should:

• Review all proposed exemptions and clarifications to assess portfolio impact.
• Coordinate with suppliers to confirm PFAS thresholds and exemption applicability.
• Prepare comments or seek clarification during the 45-day feedback window.
• Evaluate indirect risks through CMOs, CDMOs, or U.S. manufacturing partners.

To support this review process, automated regulatory intelligence tools can help teams track rule changes, assess material exposure, and prepare aligned responses.

RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 157 countries. Más información o Reserve una demostración ahora. 

Preguntas frecuentes

What PFAS categories are exempt under the proposed amendments?

The proposal exempts PFAS in mixtures or products at 0.1 percent or lower, as well as PFAS in imported articles, byproducts, impurities, research and development of chemicals, y non-isolated intermediates.

 Who is required to report under this proposal?

Reporting requirements continue to apply to manufacturers and importers active between 2011 and 2022.

When does the comment period begin and how long is it?

A 45-day public comment period begins upon publication in the Registro Federal under docket EPA-HQ-OPPT-2020-0549.

How can RegASK help companies respond to these changes?

RegASK supports companies by tracking PFAS-related regulatory updates, analyzing material- and supplier-level impacts, and enabling structured, timely feedback during public comment periods using agentic AI and expert guidance.