On Nov. 13, 2023, the U.S. Environmental Protection Agency’s (“EPA”) final rule went into effect requiring companies to report the manufacture or import of per- and poly- fluoroalkyl substances (“PFAS”), also known as “forever chemicals,” under the Toxic Substances Control Act (“TSCA”). On Nov. 30, another EPA final rule went into effect on the Toxics Release Inventory (“TRI”), which eliminates the Trump-era reporting exemption for de minimis amounts of PFAS and removes the de minimis exemption for all chemicals of special concern when notifying downstream manufacturers and purchasers.

EPA will continue to finalize PFAS regulations, including a hazardous substance designation under CERCLA and establishing enforceable levels for six PFAS known to occur in drinking water, before the 2024 presidential election. The list of “Key EPA Actions to Address PFAS” can be found here. Both the TSCA and TRI final rules are part of the Biden administration’s commitment to addressing PFAS and EPA’s PFAS Strategic Roadmap.

A summary of the TSCA and TRI final rules is below:

TSCA Final Rule

Congress amended TSCA by adding Section 8(a)(7), 15 U.S.C. Section 2607(a)(7) as part of the National Defense Authorization Act for Fiscal Year 2020 (2020 NDAA) and directed EPA to require certain PFAS reporting under TSCA. In turn, EPA promulgated the TSCA final rule to require companies that have manufactured or imported PFAS for commercial purposes since 2011 to report, among other things, PFAS uses, production volumes, transmission offsite, concentration in consumer or commercial products, byproducts, disposal, exposures, and environmental or health effects information. Generally, manufacturers must file their one-time reports by May 8, 2025.¹ “Small manufacturers” that only import “articles” containing PFAS must file reports by Nov. 10, 2025.² EPA will use the reports to create a comprehensive database of previously manufactured PFAS, improve EPA’s understanding of PFAS in commerce, and support actions to address PFAS exposure and contamination.

Unlike TSCA Section 8(a) reporting requirements for chemical manufacturers, the TSCA final rule does not have a minimum threshold for reporting; all manufacturers or importers of PFAS must report commercial use of PFAS. EPA estimates that about 97% of entities impacted by this rule meet the Small Business Association’s definition of small business. EPA created a small business compliance guide for PFAS reporting to assist small businesses.

The TSCA final rule uses a structural definition of PFAS rather than providing a list of substances subject to the rule. Specifically, the TSCA final rule defines PFAS as: any chemical substance or mixture containing a chemical substance that structurally contains at least one of three sub-structures.³

EPA has identified 1,462 chemical substances that meet this definition in the CompTox Chemicals Dashboard. EPA explained that it used a structural definition, rather than a list of substances, to capture all substances that have similar properties and “avoid inadvertently limiting the scope of reporting.” Some commentors criticized the definition on the basis that it is not used by any other federal agency or organization, it is used inconsistently by EPA, and it is overinclusive of structures not typically defined as PFAS. Manufacturers of substances that do not meet the structural definition are not required to report under this TSCA final rule, but may be subject to reporting if the substance is a “chemical substance”⁴ under TSCA.

The TSCA final rule has implications on several different items including future rulemakings, state regulations, disclosure of protect information, and business liability and enforcement risks:

• PFAS Definition and Future EPA Actions: EPA recognized in the preamble to the TSCA final rule that the definition of PFAS in the TSCA final rule differed from other definitions used by EPA and other organizations. EPA has not addressed, however, whether it will adopt this broad definition in future EPA actions or rulemakings. To date, the proposed rules designating certain PFAS as hazardous substances under CERCLA and proposing National Primary Drinking Water Regulations for certain PFAS have focused only on a small handful of well-studied PFAS.
• High Costs: EPA initially estimated the cost of the rule to be $10 million. After public comment, EPA significantly revised its estimate to be between $800 million and $847 million. Because the rule is an information-gathering rule, EPA was unable to quantify the benefits. Despite the vastly increased cost estimate, EPA reasoned that the final rule will enhance data for risk-screening and risk-management programs and allow it to more effectively evaluate and manage potential unreasonable risks, base decisions on data rather than assumptions, and tailor risk management decisions to actual risk.
• State Regulation Implications: In its 28, 2023 press release, EPA stated that the TSCA final rule will produce “actionable data” that EPA, as well as state, local and tribal governments, can use to implement laws and policies to protect people from PFAS. EPA’s definition of PFAS in the TSCA final rule (which excludes substances with only single fluorinated carbon or unsaturated fluorinated moieties) conflicts with the main state-level definition of PFAS, including California’s, which broadly defines PFAS to include any “class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”⁵ As states grapple with creating their own policies and laws for PFAS, some may adopt EPA’s definition of PFAS pursuant to the TSCA final rule instead. And the data and definitions provided by the TSCA final rule may provide states with guidance as to what PFAS compounds are prevalent and potentially harmful. Manufacturers and importers subject to state and federal reporting requirements must carefully adhere to differing PFAS definitions in their reporting requirements.
• Confidential Business Information (“CBI”) Protections: PFAS manufacturers may claim that reported information contains CBI, consistent with TSCA Section 14, 15 U.S.C. Section 2613. This includes specific chemical identities that are not on the public inventory, company identifiers, and production volumes. However, the TSCA final rule states that only confidentiality claims made through the reporting tool will be considered properly asserted, and manufacturers are required to substantiate the confidentiality claims at the time of submission. CBI claims made elsewhere will not be treated as having asserted a CBI claim under this rule, and the information may be disclosed to the public without further notice. Manufacturers should be particularly careful when submitting the required reporting to preserve CBI claims.
• Implication for Waste and Wastewater Entities Dealing with PFAS: Only those companies that manufacture or import PFAS for a commercial purpose are required to report under the final rule. Entities that simply process PFAS that they receive domestically, such as wastewater treatment plants, are not covered by the TSCA final rule unless they also manufacture PFAS for a commercial purpose, including as a byproduct.
• Enforcement Actions: At the October 2023 American Bar Association’s Section of Environment, Energy and Resources 31st Fall Conference in Washington, D.C., Assistant EPA Administrator David Uhlmann warned that EPA’s Office of Enforcement and Compliance Assurance would hold the main manufacturers responsible “for causing the problem in the United States.” He said that he expects EPA to introduce a formal regulatory scheme sometime during the first half of 2024. The required reporting will help EPA identify the largest manufacturers of PFAS and hone compliance and enforcement targets. Also note that TSCA has a citizen suit provision that allows individuals to enforce the provisions of TSCA against manufacturers and importers.⁶

TRI Final Rule

Under Section 313 of the Emergency Planning and Community Right-to-Know Act (“EPCRA”), facilities in designated industry sectors—such as manufacturing, metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment—must annually report to EPA and the applicable state or Indian Country official the quantity of certain toxic chemicals they released to the environment or otherwise managed as waste in amounts above reporting activity threshold levels.⁷ Additionally, the Pollution Prevention Act of 1990 (“PPA”) requires these facilities to report prevention, recycling and other waste management information for these same chemicals.⁸ EPA maintains the data collected under EPCRA and PPA in a database known as the TRI. There is, however, a de minimis exemption that allows facilities to ignore small concentrations of TRI-listed chemicals in mixtures or other trade name products when making threshold determinations and release and other waste management calculations.⁹

Under the Supplier Notification Requirements, reporting facilities must also notify downstream manufacturers and purchasers that the mixture or trade name product sold or otherwise distributed contains TRI-listed chemicals.¹⁰ EPA also maintains a separate list of “chemicals of special concern,” which have lower reporting and notification thresholds as even a small release of these chemicals can cause significant harm.¹¹ Notably, chemicals of special concern are excluded from the de minimis reporting and notification exemption.¹²

In the 2020 NDAA, Congress added certain PFAS and directed EPA to add other PFAS that met specific statutory criteria to the list of chemicals covered by TRI for the 2021 reporting and notification year and provided a framework for automatically adding other PFAS in future years.¹³ To date, 189 PFAS have been added to the TRI list. In codifying these provisions, Congress did not eliminate the de minimis exemption and other burden reduction provisions. Since the de minimis level is based on relative concentration rather than a specific amount, the application of this exemption to TRI-listed PFAS ended up allowing significant quantities of such PFAS to be excluded from TRI reporting and notifying.

The TRI final rule adds all PFAS included in the TRI to the EPA list of “chemicals of special concern” to align the reporting requirements of these PFAS with other highly toxic chemicals.¹⁴ By so classifying all TRI-listed PFAS as “chemicals of special concern,” the TRI final rule eliminates the availability of the de minimis exemption and requires facilities to report on all listed PFAS—regardless of their concentration in mixtures. This classification also eliminates the option to use other reporting burden reduction tools, including the options of Form A and range reporting. Further, the TRI final rule removes the de minimis exemption under the Supplier Notification Requirements for all substances on the list of chemicals of special concern, beyond just PFAS.

The TRI final rule took effect on Nov. 30, 2023, and will apply for the reporting year beginning Jan. 1, 2024. The final rule: (1) allows EPA to “receive more comprehensive data on PFAS;” (2) allows “communities to learn how facilities in their area are managing listed chemicals;” and (3) ensures that downstream manufacturers and purchasers “are informed of the[] presence [of PFAS] in mixtures and products they purchase.”¹⁵

The TRI final rule will have implications on future rulemakings, reporting and notice requirements, and business liability and enforcement risks:

• PFAS Definition and Future EPA Actions: EPA declined to provide a structural definition of PFAS as part of the TRI final rule as it was outside the scope of this rulemaking. This rulemaking only concerned the specific PFAS added to the TRI by the 2020 NDAA and did not require EPA to provide a definition of PFAS. EPA acknowledged that a separate rulemaking underway is expected to clarify the status of listed PFAS as chemicals of concern in the near future.
• Implication for Other Companies Dealing with PFAS: Industrial companies that manufacture, process or otherwise use listed PFAS or any chemicals of special concern are required to report and notify under the final rule. This includes federal facilities and facilities that the EPA administrator has specifically required to report to TRI pursuant to a determination under EPCRA Section 313(b)(2). Companies should be aware that they may have expanded PFAS reporting obligations.
• Enforcement Actions: In addition to government enforcement, EPCRA has a citizen suit provision that allows individuals to enforce the provisions of the EPCRA against facilities.¹⁶ Communities can use EPA’s TRI Toxics Tracker to map the locations of TRI-reporting facilities and find out about their chemical releases, waste management practices and pollution prevention activities. This tool may help communities evaluate potential exposure to PFAS and the prospect of a citizen suit.

¹ 40 C.F.R. Section 705.20.

² “Small manufacturer” is defined at 40 C.F.R. Section 704.3 as a manufacturer or importer with (a) annual sales (when combined with its parent company, if any) of less than $120 million subject to volumetric production or import limits, or (b) annual sales (when combined with its parent company, if any) of less than $12 million with no volumetric production or import limits. An “article” as defined at 40 C.F.R. Section 704.3 as a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles.

³ 40 C.F.R. Section 705.3.

⁴ TSCA defines “chemical substance” as “any organic or inorganic substance of a particular molecular identity, including—(I) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (II) any element or uncombined radical.” 15 U.S.C. Section 2602(2)(A).

⁵ See Cal. Health & Safety Code Section 109000 (defining PFAS in the context of plant-based food packaging as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom”).

⁶ 40 C.F.R. Section 702.

⁷ 42 U.S.C. Section 11023.

⁸ 42 U.S.C. Section 13101, et seq.

⁹ 40 C.F.R. Section 372.38 (reporting exemption); 40 C.F.R. Section 372.45(d) (notification exemption).

¹⁰ 40 C.F.R. Section 372.45.

¹¹ 40 C.F.R. Section 372.28.

¹² See 40 C.F.R. Section 372.38.

¹³ National Defense Authorization Act for Fiscal Year 2020, Pub. L. No. 116-92, 133 Stat. 1199, Section 7321(c); 40 C.F.R. Section 372.20.

¹⁴ 40 C.F.R. Section 372.28.

¹⁵ EPA Finalizes Rule to Require Enhanced PFAS Reporting to the Toxics Release Inventory (Oct. 20, 2023), available at

https://www.epa.gov/newsreleases/epa-finalizes-rule-require-enhanced-pfas-reporting-toxics-release-inventory.

¹⁶ 42 U.S.C. Section 11046.