United States: EPA's PFAS Reporting Rule Requires Broad Retroactive Disclosure Of PFAS Data

Introduction

On October 11, 2023, EPA published a final rule requiring all manufacturers (including importers) of PFAS to submit one-time reports about such chemicals to the EPA. (Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, 88 Fed. Reg. 70516 (Oct. 11, 2023) (40 C.F.R. Part 705)). The rule is retroactive and applies to PFAS that were manufactured or imported from January 1, 2011, to December 31, 2022. The information collection end-date has not been broadly published, but it appears in the EPA instructional guide.

PFAS reports must be submitted to the EPA by May 8, 2025 (18 months after the effective date). (The final rule became effective on November 13, 2023.) Small manufacturers who exclusively import articles have an additional six months to comply, meaning reports must be submitted by November 10, 2025. The rule does not create general exceptions from the reporting requirements for de minimis production levels or for small businesses. The rule is expected to result in a total one-time cost to the private sector of approximately $876 million and 11.6 million work hours in compliance.

The Background

In 2019, Congress amended the Toxic Substances Control Act ("TSCA") to require the EPA to publish a rule by January 1, 2023, requiring each person who has manufactured or imported PFAS to one-time report to the EPA. (National Defense Authorization Act for Fiscal Year 2020, Pub. L. No. 116-92, 133 Stat. 825 (2019) (codified as amended at 15 U.S.C. § 2607)). The statute explicitly directs the EPA to require reporting on PFAS chemicals that were manufactured or imported "in any year since January 1, 2011." The statute only requires reporting and does not otherwise restrict or limit the production of PFAS.

EPA published a proposed rule on November 25, 2022; (TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Notice of Data Availability and Request for Comment, 87 Fed. Reg. 72439 (proposed Nov. 25, 2022) (to be codified at 40 C.F.R. Part 705)) and a final rule on October 11, 2023, missing the statutory deadline for finalizing the rule by roughly 10 months.

What Chemicals Are Considered PFAS?

PFAS chemicals contain perfluoroalkyl moieties, making them resistant to environmental and metabolic degradation. Because of their persistence, PFAS are sometimes referred to colloquially as "forever chemicals," in that they are unlikely to fully degrade naturally after production. PFAS chemicals are found in a wide variety of industrial and consumer products. The final rule provides a structural definition for PFAS, rather than an enumerated list of covered chemicals. PFAS is defined in the final rule as a chemical substance including at least one of these three structures:

• R-(CF ₂ )-CF(R')R", where both the CF ₂ and CF moieties are saturated carbons;
• R–CF ₂ OCF ₂ -R', where R and R' can either be F, O, or saturated carbons; and
• CF ₃ C(CF ₃ )R'R", where R' and R" can either be F or saturated carbons.

EPA has determined that at least 1,462 known chemicals meet the above definition of PFAS under the final rule. The rule expands on the definition of PFAS in the proposed rule to include 41 additional PFAS. EPA explained the expanded definition covers substances that are commonly considered to be "lightly" fluorinated (i.e., the molecule only contains unconnected CF 2 or CF 3 moieties), as such substances may also be persistent in the environment. This definition may include fluoropolymers, including PTFE. EPA intends to publish a non-exhaustive list of chemicals that meet the definition of PFAS on its CompTox Chemical Dashboard. Any chemical not on the list that otherwise meets the structural definition must still be reported.

PFAS Manufacturers (Including Importers)

All entities that produce, manufacture, or import into the customs territory of the United States PFAS for a commercial purpose at any time since January 1, 2011, are considered "manufacturers" under the rule. EPA defines "manufacture for commercial purposes" to include the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer (40 C.F.R. § 705.3). Importers of articles are manufacturers for purposes of this rule. The definition includes PFAS that are produced coincidentally as a byproduct or impurity during the manufacture, processing, use, or disposal of another chemical substance or mixture. Receiving PFAS from domestic suppliers or other domestic sources is not, in itself, considered manufacturing PFAS for commercial purposes.

Many commenters urged the EPA to make exceptions to the rule for small businesses, de minimis production levels, and for importers. In general, EPA declined to create such exceptions, maintaining that it did not have the statutory authority to create such broad exemptions.

What Needs to Be Reported?

For all PFAS, EPA is requiring that manufacturers report on the chemical identity (including the trade name, chemical makeup, and molecular structure), production site information, company ownership information, production volume, worker exposure, concentration in products, uses, byproducts, disposals, and existing information on environmental or health effects. A full spreadsheet of the reporting requirements is available on the rule docket.

As it pertains to environmental and health information, EPA is requiring manufacturers to report "all existing information concerning environmental and health effects" in the submitter's possession or control. Many commenters expressed concerns about this broad requirement. In response, EPA clarified that manufacturers do not need to generally report publicly available scientific research on PFAS.

In response to other comments about the burden the rule would impose, EPA is allowing article importers and manufacturers of research and development substances in quantities below 10 kilograms per year to submit shorter and more streamlined reports.

EPA has published an instructional reporting guide and a small entity guide to help entities submit reports.

Information Known to or Reasonably Ascertainable by a Manufacturer Must Be Reported

TSCA requires manufacturers (including importers) to report required information that are known to or reasonably ascertainable by the manufacturer (15 U.S.C. 2607). EPA further defines "known to or reasonably ascertainable" to mean "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." (40 C.F.R. § 705.3)

In the final rule, EPA explains that the "known to or reasonably ascertainable standard" imposes a due diligence requirement on manufacturers. Manufacturers must conduct reasonable inquiries into their organizations, beyond just the information known to managerial and supervisory employees. In some instances, manufacturers must conduct outside inquiries to fill in knowledge gaps. EPA advises that "such activities may, though not necessarily, include 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 of the PFAS." However, EPA is not requiring manufacturers to send out new customer surveys ("sending a comprehensive set of identical questions to multiple customers") to comply with the rule.

Manufacturers that do not have actual data to report to EPA must consider whether "reasonable estimates" of such information are ascertainable. In considering whether to submit estimates, EPA provides that manufacturers "may rely, for example, on approaches such as mass balance calculations, emissions factors, or best engineering judgment."

Manufacturers that do not know and cannot reasonably make estimates for certain data, except for production volumes, may indicate such information is "Not Known or Reasonably Ascertainable" on reporting forms.

Joint Reporting

In response to public comments, EPA is permitting joint submissions for certain PFAS when suppliers will not disclose the identity of the chemicals to the manufacturer. The joint submission process allows suppliers or other entities to submit the required data to the EPA without sharing confidential chemical information with customers.

Confidential Business Information

Manufacturers may claim certain data as confidential business information ("CBI"). To assert that data is CBI, the manufacturer must certify it has:

• Taken reasonable measures to protect the confidentiality of the information;
• Determined the information is not required to be disclosed or made public under federal law;
• A reasonable basis to believe that disclosure of the information is likely to cause substantial competitive harm; and
• A reasonable basis to believe that the information is not readily discoverable through reverse engineering.

Chemicals on the public (non-confidential) inventory and generic chemical names are generally not CBI. In addition, information from health and safety studies are not protected from disclosure, except in limited circumstances.

Effective Date

The rule provides for a one-year information collection period following the November 13, 2023, effective date, followed by a six-month reporting period. As such, the submission period begins on November 12, 2024, and ends on May 8, 2025. Small manufacturers (as defined at 40 C.F.R. § 704.3) who exclusively import articles will have an additional six months to comply, meaning their submission period opens on November 12, 2024, and ends on November 10, 2025.

The EPA defines "small manufacturers" to include manufacturers who meet one of two standards: (i) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $120 million, and the annual production volume of a chemical substance is less than 100,000 lbs.; or (ii) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $12 million. (40 C.F.R. § 704.3)

Recordkeeping

Manufacturers subject to the reporting requirements must retain records that document any information reported to EPA for five years, beginning on the last date of the information submission period.

Penalties For Noncompliance

Under Section 15(3) of TSCA, it is unlawful for any person to fail to submit information required under the rule or to fail to provide EPA access to records pertaining to the submission. Any person who violates the aforementioned requirements may be liable for civil penalties and/or criminally prosecuted.

TSCA enables the government to seek judicial relief to compel submission of TSCA reportable information and to otherwise restrain against violations. TSCA allows for EPA inspections to assure compliance. The EPA administrator may also issue subpoenas to require the attendance and testimony of witnesses and the production of reports, papers, documents, answers to questions, and other information.

Looking Ahead

Manufacturers and importers should assess whether they have reporting obligations under the rule. While conducting such assessments, entities should ensure they follow appropriate due diligence standards as outlined in the rule. EPA has published a number of documents to assist manufacturers in assessing their obligations and reporting requirements, including an instructional reporting guide; a small entity guide; PFAS lists published by EPA on the CompTox Chemical Dashboard; and the reporting requirements spreadsheet.

Although final reports are not due to the EPA for 18 or 24 months from the effective date (May 8, 2025, and November 13, 2023), entities should start preparing and collecting the necessary information. Such preparations may include coordinating with suppliers and downstream users, preparing joint reports, and working to protect confidential business information.

Three Key Takeaways

1. Manufacturers and importers should assess whether they have reporting obligations and should ensure they follow appropriate due diligence standards as outlined in the rule.
   
2. EPA has published an instructional reporting guide and a small entity guide to help entities submit reports. Entities should review such guides and the final rule prior to conducting assessments to ensure they are familiar with EPA's expectations.
   
3. Manufacturers and importers should start preparing and collecting the necessary information as soon as possible to ensure there is sufficient time to compile and report. Due to the broad and expansive nature of the reporting requirements, compiling the necessary information could take a considerable amount of time depending on the size and nature of the company.