Starting July 11, 2025, U.S. companies who manufactured or imported Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS, a.k.a. “forever chemicals”) for a commercial purpose between January 1, 2011, and December 31, 2022, must report certain information to the U.S. Environmental Protection Agency (EPA). This includes PFAS present in articles or byproducts and, unlike other reporting rules, PFAS present as an impurity is not exempt from reporting. This new rule, published by the EPA on October 11, 2023 (88 Fed. Reg. 70516) and amended on September 5, 2024 (89 Fed. Reg. 72336), stems from the reporting and recordkeeping requirements for PFAS under section 8(a)(7) of the Toxic Substances Control Act (TSCA).
The new rule imposes significant reporting and record-keeping requirements on U.S. manufacturers and importers of all sizes. Here is a look into the reporting requirements under the new rule and what U.S. manufacturers and importers need to know to comply.
epa's new rule
The rule imposes a one-time reporting requirement upon any person who manufactured (including imported) PFAS for a commercial purpose at any time between January 1, 2011, to December 31, 2022. PFAS manufactured for a “commercial purpose” is broadly interpreted by the EPA to include PFAS present in an imported article, as an impurity or in a mixture, and in a byproduct.
Manufacturers and importers subject to the rule must electronically report information about PFAS uses, production volumes, exposures, environmental and health hazards, and disposal. Notably, small manufacturers are not exempt from the requirements under this rule.
What are PFAS?
For the purposes of this rule, the EPA has defined “PFAS” as any chemical substance that structurally contains at least one of the following sub-structures:
- R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons (since the R groups are not defined, R, R’, and R’’ may be any substituent).
- R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons (i.e., R and R’ may be any of the following: a fluorine atom, an alcohol or ether; or any substituent bonded to the backbone by a saturated carbon atom such as a CH2 group).
- CF3C(CF3)R’R’’, where R’ and R” can either be F or saturated carbons (i.e., R’ and R” may be a fluorine atom or any substituent bonded to the backbone by a saturated carbon atom such as a CH2 group).
Reporting Requirements
Manufacturers and importers subject to the rule will have a six-month period to gather and submit all information that must be reported to the EPA. The reporting period begins on July 11, 2025, and ends on January 11, 2026. All submitters will generate their reports electronically through the EPA’s Central Data Exchange system (CDX). Submitters must register with CDX before submitting data.
Two types of forms will be available for reporting: the Standard Form and the Streamlined Form. Most manufacturers and importers will use the Standard Form. Streamlined reporting is available for importers of articles containing PFAS and to manufacturers/importers of PFAS that are used exclusively for research and development purposes in quantities below 10 kgs. per year.
Submitters must exercise a certain level of due diligence when gathering information that is reportable under the rule. The EPA has imposed a reporting standard to help submitters determine what information must be reported. Under that standard, submitters must report any information that is “known to or reasonably ascertainable by” them. The EPA defines this reporting standard to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.”
Submitters are not required to conduct sampling or testing to satisfy the reporting standard, nor are submitters required to conduct new or additional customer surveys to obtain reportable information. Submitters may rely on existing information and data when reporting, and where such data do not exist, they may report using reasonable estimates. However, some up-stream inquiry to suppliers may be required to fill in any gaps in the submitters’ knowledge when reporting.
Manufacturers and importers subject to the rule must report certain data to the EPA, including:
- Information on the U.S. parent company subject to the reporting rule.
- Information on the manufacturing site being reported under the rule.
- Identification of chemical substance information for each chemical substance or mixture.
- The categories of use for each reportable substance or mixture.
- Manufacturing, processing, and use information for each substance or mixture.
- A description of the byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture.
- All existing information concerning the environmental and health effects of each substance or mixture.
- The number of individuals exposed at the manufacturing site, and reasonable estimates of the number of workers that will be exposed, to each substance or mixture.
- The manner or method to dispose of each substance or mixture and any change in the manner or method.
In certain instances, joint submissions may be required. Joint submissions are required where confidentiality concerns prevent a company, such as a contracting company or a foreign supplier, from disclosing certain chemical substance identifiers to the manufacturer or importer. In such cases, the manufacturer or importer becomes the primary submitter that is responsible for initiating a joint submission. The contractor or supplier becomes the secondary submitter. The primary submitter must notify the secondary submitter of the joint submission using the reporting tool. The primary submitter will separately report its portions of the required information, and the secondary submitter will report its information directly to the EPA to preserve confidentiality.
If a submitter wishes to claim certain information as confidential, such confidentiality claims must be made and substantiated at the time of submission. However, certain information may not be claimed as confidential, including certain processing and use data elements or a submission response that is designated as “not known or reasonably ascertainable.”
Submitters must maintain records for five years from May 8, 2025 (the last day of the reporting period).
Next Steps
Manufacturers and importers who believe they are subject to this new rule should prepare for the six-month reporting period, which begins July 11, 2025, and ends January 11, 2026. Those subject to the rule should register with the EPAs CDX system and begin gathering the necessary information and records for their submission.
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About the Authors
Chris Leason is an environmental shareholder at Gallagher & Kennedy, focusing on regulatory compliance and civil enforcement defense in the areas of hazardous waste, toxic substances, chemical facility anti-terrorism standards, regulatory enforcement, rulemaking, litigation risk management, and due diligence audits.
RivaLee Ferland is an associate at Gallagher & Kennedy practicing in environmental law, employment disputes, and civil, commercial, and personal injury litigation. As part of her environmental practice, she focuses on regulatory compliance, TSCA reporting requirements, and Superfund site work.