The U.S. Environmental Protection Agency recently established a one-time per- and polyfluoroalkyl substances reporting rule pursuant to the federal Toxic Substances Control Act.
Pursuant to the rule, most companies that manufactured or imported certain PFAS or PFAS-containing “articles” between 2011 to 2022 (even if only once) must submit detailed information about those PFAS subject to the rule, compound by compound, to EPA by May 8, 2025.
The reports require information on chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposures, and disposal methods.
The rule is broad by design and applies to virtually all manufacturers and importers, even those who may never have had any reporting obligations under TSCA.
With PFAS present in so many industrial and consumer products, most manufacturers and importers will have something to report.
Domestic manufacturers and importers not typically subject to TSCA reporting regulations should undertake proper due diligence to determine their compliance obligations and implications going forward.
The scope and definitions of key terms in the rule (e.g., manufacture) are nuanced and compliance obligations should be evaluated carefully.
Download a PDF here with highlights of the below.
Step 1: Assemble the Right PFAS Team
Every U.S. manufacturer and importer should assemble a multidisciplinary team to develop a strategic approach for the collection and reporting of required PFAS business information to comply with the rule but also to minimize potential future liability.
This may include understanding the scale of the project based on import/manufacturing volume and developing a comprehensive standard operating procedure detailing the methodologies for gathering information and the results of the company’s inquiries.
For example, consider including an environmental expert/consultant and legal counsel with TSCA experience.
Engaging any outside environmental expert/consultant through legal counsel is typically recommended as it can offer attorney-client privilege protections, as discussed below.
Step 2: Complete Relevant Due Diligence
It is important to note that “articles” incorporating a PFAS-containing substance (e.g., items with defined shapes as part of their end function, such as non-stick cookware; clothing treated with a PFAS-based stain repellent; furniture treated with a PFAS-containing coating to resist surface smudging) are subject to the new TSCA reporting rule.
Many manufacturers and importers that have previously been exempt from TSCA reporting will be subject to this PFAS-specific rule.
The due diligence plan should be scoped in a way that makes sense for each business and may require a robust analysis of a business’s entire supply chain.
The rule does not require entities to test for PFAS; however, manufacturers and importers must report information that is “known or reasonably ascertainable.”
The initial due diligence step should confirm whether reporting is necessary and whether additional information will be needed from suppliers and/or internal personnel to address the required reporting categories in EPA’s reporting form.
Step 3: Understand and Mitigate Potential Risks
The internal due diligence effort may identify potential compliance gaps and other information that will likely become information in the public domain.
Such information may include, for example, the use of chemicals that should be (but are not yet) registered on EPA’s TSCA inventory, data inconsistent with other governmental reports, missed filings required to be made under other reporting requirements (e.g., Chemical Data Reporting, Tier II, Toxics Release Inventory), occupational safety concerns, incomplete safety data sheets, or product liabilities (e.g., design defects or false advertising).
While TSCA allows certain confidential business information to be protected, the definition of CBI is narrowly crafted and EPA’s process to claim CBI must be followed.
In some cases, voluntary self-disclosures to EPA (and state environmental agencies) may be advisable before the PFAS reports are submitted.
Although not the intent of this reporting rule, government agencies, plaintiff lawyers, customers, and even employees also might use reported data to support PFAS-related claims.
In fact, the plaintiffs’ bar can be expected to seek submitted information under federal and state Freedom of Information Acts to provide potential fodder for private party lawsuits.
Notably, a large personal care products company was sued recently in a proposed class action in California based on required disclosures under Maine’s reporting rule.
Engaging experienced legal counsel early to help facilitate the team’s work and potentially protect certain communications under attorney-client privilege can be vital to offset litigation risks.
Step 4: Appropriately Document Findings
U.S. manufacturers/importers subject to the new rule must report information for each PFAS compound, broken down by year from 2011 to 2022, inclusive.
This process should be handled methodically to avoid redundancies.
We recommend that companies consider the preparation of a final internal memo that documents the process used for seeking the relevant information, how results were addressed and why certain information was and was not disclosed (e.g., some PFAS may be out of scope, some PFAS may be used but not manufactured or imported by the reporting company).
Even if a company determines no report is required pursuant to the new rule, documenting the results of the due diligence effort can be critically important to addressing any future EPA compliance inquiry or inspection.
Step 5: Report and Maintain Records
Most companies must file their reports by May 8, 2025 on the standard reporting form to be provided by EPA.
Companies reporting exclusively as “small” importers have until Nov. 10, 2025.
Article importers (of any size) have the option of using a more streamlined reporting form with fewer technical categories than the standard form.
All reports must be submitted through EPA’s online Central Data Exchange. Records of this reporting event must be maintained for five years.
This article first appeared on CBIA's website and is published here with permission.
