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EPA recently finalized a broad PFAS reporting rule under the Toxic Substances Control Act, requiring that manufacturers and importers of PFAS and articles containing PFAS disclose information regarding the use of PFAS from January 1, 2011 to December 31, 2022.

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The new TSCA rule will require manufacturers and importers to submit all known or reasonably ascertainable information about PFAS for the twelve year period in their organizations and may require limited third party diligence.

Most manufacturers and importers of PFAS and PFAS-containing articles must electronically report this data to EPA by no later than May 2025.

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On October 11, 2023, the U.S. Environmental Protection Agency (EPA) published a final rule under the Toxic Substances Control Act (TSCA) Section 8(a)(7), requiring manufacturers to submit a one-time report to the Agency outlining their use of per- and polyfluoroalkylated substances (PFAS) in every year since 2011.<a id="_ftnref1" href="#_ftn1">[1]</a> The rule requires any manufacturer or importer of PFAS or articles containing PFAS to submit a broad set of information – including chemical names and identities, manufactured or imported volumes, processing data, byproducts and disposal – to EPA within 18 months of the rule’s effective date (May 8, 2025). Smaller manufacturers have an additional six months to report.

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Congress developed the one-time reporting rule under the National Defense Authorization Act of 2020 (NDAA). Congress directed EPA to promulgate a rule requiring any person who manufactured a PFAS substance after January 1, 2011, to report on those activities. The NDAA also added PFAS to the list of toxic chemicals covered by the Toxics Release Inventory under the Emergency Planning and Community Right-to-Know Act and required EPA to issue guidance on the best PFAS disposal methods. That rule also has been recently finalized, with an effective date of November 30.<a id="_ftnref2" href="#_ftn2">[2]</a>

The TSCA rule is limited to those that have “manufactured for commercial purposes,” which includes importers.<a id="_ftnref3" href="#_ftn3">[3]</a> Companies should be aware that EPA’s definition of manufacturers includes (i) both manufacturers and importers of PFAS substances as well as (ii) manufacturers and importers of articles containing PFAS.<a id="_ftnref4" href="#_ftn4">[4]</a> It can also apply to manufacturers of PFAS as a byproduct.<a id="_ftnref5" href="#_ftn5">[5]</a> The rule does not extend to retailers or distributors of PFAS or PFAS-containing articles.

Covered manufacturers are required to report on their use of PFAS substances from January 1, 2011, through the end of 2022.<a id="_ftnref6" href="#_ftn6">[6]</a>

Under the rule, EPA opted for a structural definition of PFAS, which is different from other definitions. Specifically, EPA is interested in PFAS substances that meet one of the three structural definitions below:

R-(CF2)-CF(R′)R″ where both the CF2 and CF moieties are saturated carbons.

R-CF2-OCF2-R′ where R and R′ can either be F, O or saturated carbons.

CF3-C(CF3)R′R″ where R′ and R″ can either be F or saturated carbons.<a href="#_ftn7" id="_ftnref7">[7]</a>

While this is not the broadest possible definition of PFAS, EPA expressly noted in its rulemaking that fluoropolymers “are reportable under this rule; this includes higher molecular weight fluoropolymers.”<a href="#_ftn8" id="_ftnref8">[8]</a>

EPA includes a substantial list of data that manufacturers must report. This includes company and plant site information for each site at which a reportable chemical substance is manufactured.<a id="_ftnref9" href="#_ftn9">[9]</a> Manufacturers must also report the chemical name and identity; molecular structure; physical form of chemical; industrial processing and use information; consumer and commercial use information; manufactured quantities (including production volumes); whether the uses are site-limited; maximum quantity stored on-site; total volume recycled on-site; byproducts related to manufacturing, processing, use or disposal of PFAS substances; potential exposure to employees; and potential health effects. To aid manufacturers in reporting this information, the EPA has published <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0549-0187">a guidance worksheet</a> outlining the various reporting elements.

What obligations are manufacturers under to gather this information?

EPA expressly stated in its rulemaking that manufacturers and importers are required to report information “to the extent they know or can reasonably ascertain” that information.<a id="_ftnref10" href="#_ftn10">[10]</a> This includes “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.”<a id="_ftnref11" href="#_ftn11">[11]</a> Those subject to reporting must “conduct a reasonable inquiry” and report data “within the full scope of their organization (not just information known to managerial or supervisory employees).”<a id="_ftnref12" href="#_ftn12">[12]</a> EPA’s “reasonable inquiry” standard may also include “inquiries outside the organization to fill gaps in the submitter’s knowledge.”<a id="_ftnref13" href="#_ftn13">[13]</a>

The rule places a heavy burden on manufacturers to gather all the information in the organization required under the reporting rule for a 12-year period, dating back long before manufacturers knew the information might be reportable. While the obligations for collection of information from third parties are less certain, EPA has indicated it expects companies to fill informational gaps based on information the manufacturer “might be expected to possess, control, or know.”<a href="#_ftn14" id="_ftnref14">[14]</a> If manufacturers cannot find information, they may respond that the information is “Not Known or Reasonably Ascertainable (NKRA).”<a href="#_ftn15" id="_ftnref15">[15]</a>

The rule goes into effect on November 13. The first 12 months of the reporting period have been designated for data collection. The submission period will begin one year following November 13 and continue for six months. For most manufacturers, the submission window will be November 12, 2024, through May 8, 2025.<a id="_ftnref16" href="#_ftn16">[16]</a> However, small manufacturers (as defined at 40 CFR §704.3) that are only article importers will have a submission period beginning November 12, 2024, and ending Nov. 10, 2025.<a id="_ftnref17" href="#_ftn17">[17]</a>

All reporting under the new TSCA reporting rule will be done electronically through EPA’s Central Data Exchange. EPA is developing a reporting tool specifically for use in reporting this data which will be available at a later date.

Unlike with other past PFAS or chemical reporting rules, EPA has not created any express exemptions or exceptions for this rule. Small businesses are not exempt, and there is no de minimis exemption for low volumes of PFAS manufactured or imported.

However, manufacturers that have previously submitted information under the Chemical Data Reporting (CDR) rule are not required to report duplicative information to EPA.<a href="#_ftn18" id="_ftnref18">[18]</a> Additionally, the final rule does not require reporting for the “import of municipal solid waste streams for the purpose of disposal or destruction of the waste.”<a href="#_ftn19" id="_ftnref19">[19]</a> Reporting is also not required for federal agencies importing PFAS when it is not for any immediate or eventual commercial advantage.<a href="#_ftn20" id="_ftnref20">[20]</a>

What about Confidential Business Information?

EPA will allow manufacturers submitting a report to claim portions of the report as Confidential Business Information (CBI). The manufacturer will be required to substantiate such claims, and some types of information, such as the specific identity of PFAS substances, will be exempt from CBI treatment.<a id="_ftnref21" href="#_ftn21">[21]</a> Manufacturers and importers will be required to follow EPA’s CBI guidance in order to ensure protection of confidential and proprietary information submitted under the rule. If CBI claims are not asserted, information submitted under the rule may be publicly available from EPA.

EPA is requiring manufacturers to keep all records of submissions under the rule for a five-year period, which begins on the last date of the submission period. This is consistent with the CDR rule.<a id="_ftnref22" href="#_ftn22">[22]</a>

If I am a manufacturer subject to this rule, what should I do next?

If you think your company could be required to report under TSCA Section 8(a)(7), it is important to determine whether you are a manufacturer or an importer of PFAS or of a PFAS-containing article. If you are required to report, begin evaluating the type of information your company may need to gather, dating back to January 1, 2011. Given EPA’s requirement that companies report all information known or reasonably ascertainable, it may be helpful to seek the advice of legal counsel in developing a reporting strategy.

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<a href="#_ftnref1" id="_ftn1">[1]</a> See 88 Fed. Reg. 70516.

<a href="#_ftnref2" id="_ftn2">[2]</a> See 88 Fed. Reg. 74360.

<a href="#_ftnref3" id="_ftn3">[3]</a> See 40 CFR §705.1.

<a href="#_ftnref4" id="_ftn4">[4]</a> See 40 CFR §705.3. (definition of article).

<a href="#_ftnref5" id="_ftn5">[5]</a> See 40 CFR §705.3 (definition of manufacture for commercial purpose). Under the definition of “manufacture for commercial purpose,” EPA indicates that the manufacture of “substances that are produced coincidentally during the manufacture, processing, use or disposal of another substance or mixture containing a chemical substance, including both byproducts that are separated from that other substance or mixture containing a chemical substance and impurities that remain in that substance or mixture containing a chemical substance.” The byproducts or impurities may or may not have commercial value, but because they are produced for the purpose of obtaining a commercial advantage, they are part of the manufacture for a commercial purpose.

<a href="#_ftnref6" id="_ftn6">[6]</a> See 40 CFR §705.10 (requiring reporting “through the end of the last calendar year prior to November 13, 2023…”).

<a href="#_ftnref7" id="_ftn7">[7]</a> See 40 CFR §705.3 (definition of Per- and polyfluoroalkyl substances or PFAS).

<a href="#_ftnref8" id="_ftn8">[8]</a> 88 Fed. Reg. 70519.

<a href="#_ftnref9" id="_ftn9">[9]</a> See 40 CFR §705.15(a).

<a href="#_ftnref10" id="_ftn10">[10]</a> 88 Fed. Reg. 70520.

<a href="#_ftnref11" id="_ftn11">[11]</a> 88 Fed. Reg. 70520.

<a href="#_ftnref12" id="_ftn12">[12]</a> 88 Fed. Reg. 70520.

<a href="#_ftnref13" id="_ftn13">[13]</a> Id.

<a href="#_ftnref14" id="_ftn14">[14]</a> 88 Fed. Reg. 70521.

<a href="#_ftnref15" id="_ftn15">[15]</a> Id.

<a href="#_ftnref16" id="_ftn16">[16]</a> 40 CFR §705.20.

<a href="#_ftnref17" id="_ftn17">[17]</a> 40 CFR §705.20.

<a href="#_ftnref18" id="_ftn18">[18]</a> See 40 CFR §705.22.

<a href="#_ftnref19" id="_ftn19">[19]</a> 40 CFR §705.12.

<a href="#_ftnref20" id="_ftn20">[20]</a> 40 CFR § 705.12.

<a href="#_ftnref21" id="_ftn21">[21]</a> See 40 CFR §705.30.

<a href="#_ftnref22" id="_ftn22">[22]</a> See 88 Fed. Reg. 70530.

New EPA PFAS Reporting Rule May Pose Challenge for Manufacturers and Importers

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