Extracted from Law360
On Sept. 5, the U.S. Environmental Protection Agency published a notice in the Federal Register extending the Toxic Substances Control Act, or TSCA, reporting and recordkeeping timelines for per- and polyfluoroalkyl substances, or PFAS.
The original reporting date for the rule was Nov. 12. The EPA has extended the start of the reporting period by eight months, to July 11, 2025.
This reporting period runs for 12 months for certain importers of PFAS-containing articles who also meet the regulatory definition of a small manufacturer. The reporting period for all other required reporters is six months, and is now due to end on Jan. 11, 2026. According to the EPA, the extension is due to increased agency responsibilities, technical difficulties and budgeting shortfalls.
The EPA's extended reporting timeline not only offers relief to the regulated community, but also highlights the complexity of PFAS reporting. Businesses subject to this rule will now have additional time to come into compliance and make certain they are collecting accurate data on the manufacturing and importing of PFAS. Despite this extension, businesses must remain diligent and thorough in their data collection and reporting efforts.
PFAS
PFAS are widely used, manufactured chemicals that break down slowly over time. They are present at low levels in many commercial, industrial and consumer products, as well as in the environment. The EPA believes that the widespread use and persistence of PFAS make it challenging to study and evaluate their potential health and environmental risks.
TSCA PFAS Reporting and Recordkeeping Rule
On Oct. 11, 2023, the EPA published the final rule on the TSCA reporting and recordkeeping requirements for PFAS. The rule requires entities that have manufactured or imported PFAS or PFAS-containing articles for a commercial purpose since Jan. 1, 2011, to provide information to the EPA on their uses, production volumes, disposal, exposures and hazards.
This reporting must include any amount of PFAS that were "known to or reasonably ascertainable by" the manufacturer or importer, even if added accidentally or in trace amounts.
The EPA has identified the following nonexhaustive list of North American Industry Classification System, or NAICS, codes of potentially affected entities:
- Construction (NAICS code 23)
- Manufacturing (NAICS codes 31 through 33)
- Wholesale trade (NAICS code 42)
- Retail trade (NAICS codes 44 through 45)
- Waste management and remediation services (NAICS code 562)
This rule does not require reporting on substances that are excluded from the definition of "chemical substance" in TSCA Section 3(2)(B), such as certain pesticides, medical devices, foods and cosmetics.
Change to Submission Period
On Sept. 5, the EPA amended the rule by shifting the start of the data submission period from Nov. 12 of this year to July 11, 2025, with a corresponding change made to the reporting deadline.
A 12-month reporting period was previously provided for those entities that may submit a report under the streamlined reporting requirements of Title 40 of the Code of Federal Regulations, Section 705.18(a) — i.e., article importers — and that also meet the regulatory definition of a small manufacturer under Section 704.3.
Based on this extension, the 12-month reporting period will now end on July 11, 2026. For all other entities required to report under this rule, the EPA has provided a six-month reporting period, which will end on Jan. 11, 2026.
According to the EPA, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, passed in 2016, considerably expanded the scope of the EPA's responsibilities under the TSCA. The agency also claims that its appropriated resources for implementing the TSCA have not kept pace with the agency's activities and obligations under the amended TSCA. These responsibilities and reduced funding forced the EPA to delay the original reporting start date.
In the direct final rule, the EPA explains that the amount of data expected to be submitted is unprecedented, due to the number of chemicals and years of data for which this reporting requirement applies. The EPA also highlights the critical need to ensure the fidelity of the process and the data, which can only be achieved by delaying the start of the reporting period.
According to the EPA, the original reporting timeline is "no longer tenable," as it would force companies to submit data before the agency has the capacity to process them. To ensure that the infrastructure underlying the data collection process is working optimally, the EPA is extending the start of the reporting period by eight months — ensuring, ultimately, public access to this information.
Technical Correction
In addition to extending the reporting timeline, the EPA's new rule includes a technical correction to address a typographical error in the original rule. The text at Section 705.15(f)(1) incorrectly required PFAS manufacturers to submit Organization for Economic Cooperation and Development's harmonized templates for published study reports.
The EPA has now clarified in the new rule that it intends to apply this requirement only to unpublished study reports. Thus, the updated language replaces the word "published" with "unpublished," aligning the requirement with the agency's original goal of gathering nonpublic data.
Implications for Regulated Businesses
The EPA's extension should bring temporary relief to businesses affected by this unprecedented rule. The extension is certain to benefit businesses by giving them additional time to prepare and submit the required PFAS data.
Despite this relief, however, the scope of the rule has not changed. Businesses should remain proactive in collecting the necessary information because the rule mandates reporting all data "known or reasonably ascertainable" by the organization. This requires a comprehensive internal review to make certain all relevant data is captured.
The rule's broad scope is significant. It includes PFAS present as impurities, byproducts or in trace amounts, unlike many state laws that focus only on intentionally added PFAS. Even trace amounts of PFAS in a single product or component could trigger reporting obligations, making it critical for businesses to carefully assess all potential sources of PFAS in their operations.
While the extension reduces the immediate pressure of the original timeline and minimizes the risk of incomplete data submissions due to technical delays, it also underscores the need for thorough due diligence.
Businesses, particularly those with complex supply chains, may need several months to collect and verify the required data. It is crucial that companies continue their efforts to meet the new timeline to ensure full compliance and avoid penalties. This may include some of the following.
Scope of PFAS
Businesses should determine whether they import or manufacture PFAS or PFAS-containing articles that fall under the scope of the rule. The EPA has identified at least 1,364 PFAS under the regulatory structural definition, including (1) all PFAS listed as active on the February 2021 TSCA inventory, and (2) all PFAS with TSCA Section 5 (new chemicals) low volume exemption claims.
Businesses should track the rule's docket supporting files, which will include lists of PFAS on the TSCA inventory or submitted as new chemical low volume exemptions, and structural diagram examples. This will ensure compliance by capturing any PFAS that could not be specifically listed due to confidential business information claims.
Internal Data Collection and Review
Businesses should conduct internal audits, inquiries and reviews to accurately identify and compile information on the uses, production volumes, disposal, exposures and hazards of PFAS and PFAS-containing articles.
The EPA has stated that such efforts may include "inquiries outside the organization to fill gaps in the submitter's knowledge," such as "phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing."
Companies With Complex Business Structures
Many businesses have a parent company and subsidiaries, which raises questions on whether the parent company can report on behalf of subsidiaries. In some cases, parent companies may report information on behalf of multiple subsidiaries.
Under Section 705.10, the reporting obligation falls to the entities who have manufactured or imported the PFAS. It is ultimately the manufacturer's or importer's responsibility to report appropriately under the rule, notwithstanding the complexity of its own business structure.
Further, the rule requires information to reflect all known or reasonably ascertainable information that is in the possession or control of the manufacturing site and its subsidiaries or general partnerships, and their relevant employees. If a parent company has access to all known or reasonably ascertainable information in possession or control of its manufacturing sites, reporting on behalf of those sites may be appropriate.
Reporting Software and Streamlined Reporting
Business should develop familiarity with the EPA's reporting software, which is expected to help streamline the submission process, and be fully functional by July 2025.
Streamlined reporting is available using the article importer form for importers of articles and for manufacturers of less than 10 kilograms of a substance used solely for research and development.
Retailer Obligations
Any retailer that has been an importer of record, in any year between 2011 and 2022, of a product that contains any PFAS is covered by the rule. All parties involved in the import transaction should consider the definition of "importer" when determining who may be responsible for reporting under the rule.
Confidential Business Information
Businesses should also determine whether information submitted pursuant to the rule qualifies as confidential business information, or CBI. Such claims must be made at the time of submission, and substantiated in accordance with TSCA and the PFAS data reporting rule.
Submitters must provide upfront substantiation of all confidentiality claims, except for claims made for import or yearly production volume information. Businesses that do not know the underlying identity of a chemical, other than a generic chemical name — i.e., they do not have a Chemical Abstracts Service registry number, TSCA accession number or low volume exemption number — are not required to assert and substantiate a CBI claim for chemical identity.
Also, reporters using the article importer form are not required to assert and substantiate a CBI claim for specific chemical identity.
Conclusion
Companies must remain diligent in gathering and verifying the required data to ensure full compliance. While providing more time, the EPA's delay demands continued effort to meet the reporting requirements, minimize risk and avoid penalties.
Additionally, the EPA has emphasized that the volume of data expected under this rule is unprecedented, covering numerous chemicals and years of data. This complexity necessitates a thorough and accurate data collection process.
Businesses that fail to utilize this additional time effectively may risk submitting incomplete or inaccurate data, leading to noncompliance. This is crucial for businesses coordinating data collection across multiple facilities, suppliers and corporate entities.