Perfluoroalkyl and Polyfluoroalkyl Substances Data Reporting and Recordkeeping Under the Toxic Substances Control Act; Revision to Regulation

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Revision to Regulation

DATES:

Comments must be received on or before December 29, 2025. Comments on the information collection provisions of this proposed rule under the Paperwork Reduction Act (PRA) must be received by the Office of Management and Budget's Office of Information and Regulatory Affairs (OMB-OIRA) on or before December 15, 2025. Please refer to the PRA section under "Statutory and Executive Order Reviews" in this preamble for specific instructions.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This action may apply to you if you have manufactured (defined by statute at 15 U.S.C. 2602(9) to include import) PFAS for a commercial purpose at any time from January 1, 2011, through December 31, 2022. The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Utilities (NAICS code 22);
• Manufacturing (NAICS codes 31 through 33);
• Wholesale trade (NAICS code 42); and
• Waste management and remediation services (NAICS code 562).

This list details the types of entities EPA is currently aware could potentially be impacted by this action. Other types of entities could also be impacted. To determine whether your entity is impacted by this action, please examine the applicability criteria found in 40 CFR 705.10 and 705.12. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

Any use of the term "PFAS" or "perfluoroalkyl or polyfluoroalkyl substance" refers to chemical substances that meet the structural definition of PFAS codified at 40 CFR 705.3. PFAS is defined as 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.

For a more thorough discussion of the chemical substances included in this rule, please see Unit III.A of the final rule (88 FR 70516, October 11, 2023) (FRL-7902-02-OCSPP).

This rule does not require reporting on substances that are excluded from the definition of "chemical substance" in TSCA section 3(2)(B). Those exclusions include, but are not limited to: any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)) when manufactured, processed, or distributed in commerce for use as a pesticide; any food, food additive, drug, cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic Act (FFDCA), when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device; tobacco or any tobacco product; any source material, special nuclear material, or byproduct material as such terms are defined in the Atomic Energy Act of 1954 (AEA); or, any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954. A PFAS may be considered a "chemical substance" as defined under TSCA for some, but not all, uses of the PFAS. Some uses may be excluded from the definition of "chemical substance," as outlined under TSCA section 3(2)(B). PFAS considered to be a "chemical substance" pursuant to the TSCA definition may require reporting for such uses.

B. What is the Agency's authority for taking this action?

As with the final rule published in the Federal Register on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP), and direct final amendment published on September 5, 2024 (89 FR 72336) (FRL-7902.1-02-OCSPP), EPA is proposing this rule pursuant to its authority in TSCA section 8(a)(7) (15 U.S.C. 2607(a)(7)). The National Defense Authorization Act for Fiscal Year 2020 (NDAA) (Pub. L. 116-92, section 7351) amended TSCA section 8(a) in December 2019, adding TSCA section 8(a)(7), titled "PFAS Data." TSCA section 8(a)(7) requires EPA to promulgate a rule "requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011" to report information described in TSCA section 8(a)(2)(A) through (G). TSCA section 8(a)(2)(A) through (G) includes a broad range of information, such as information related to chemical identity and structure, production, use, byproducts, exposure, disposal, and health and environmental effects.

EPA has authority to reconsider and revise previous decisions and to revise, replace, or repeal a decision to the extent permitted by law and supported by reasoned explanation. See FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983); see also FDA v. Wages and White Lion Investments, LLC, 145 S. Ct. 898 (2025). In other words, unless provided otherwise by statute, an agency may revise or rescind prior actions so long as it acknowledges the change in position, provides a reasonable explanation for the new position, and considers legitimate reliance interests in the prior position.

C. What action is the Agency taking?

EPA is proposing to amend the one-time PFAS reporting and recordkeeping regulation finalized on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP) to incorporate the following exemptions to the scope of reportable manufacturing activities: a de minimis exemption of 0.1%; imported articles; byproducts; impurities; research and development (R&D); and non-isolated intermediates. The Agency is further proposing technical corrections to the reporting requirements for the purpose of clarifying what must be reported in certain data fields and to adjust the data submission period of the reporting regulation. While EPA is proposing no other amendments to the scope of the regulation, including to the period for which reporting is required, the Agency is also seeking comment on certain other aspects of the regulation.

D. Why is the Agency taking this action?

In a series of Executive Orders, President Trump has directed agency heads to review regulations under their jurisdiction for consistency with law and Administration policy and to identify inconsistent regulations for potential recission or modification. For example, Executive Order 14219, "Ensuring Lawful Governance and Implementing the President's `Department of Government Efficiency' Deregulatory Initiative," directs agencies to initiate a process to review existing rules for consistency with the best reading of the governing statute, Administration policy, cost-benefit balancing principles, and to rescind or revise regulations as appropriate (90 FR 10583, February 19, 2025). Among the categories of regulations to be identified are those that significantly and unjustifiably impede technological innovation, infrastructure development, disaster response, inflation reduction, R&D, economic development, energy production, land use, and foreign policy objectives and those that impose undue burdens on small business and impede private enterprise and entrepreneurship.

Consistent with Executive Order 14219 and the Administration's priorities, EPA identified the TSCA section 8(a)(7) PFAS reporting regulation for reconsideration. The Agency is reconsidering exempting certain reportable activities. The Agency has identified several aspects of the TSCA section 8(a)(7) PFAS reporting regulation for potential revision in light of TSCA section 8(a)(5):

• TSCA section 8(a)(5)(A) directs the Agency, to the extent feasible, to not require unnecessary or duplicative reporting. After reconsidering its earlier position in the 2023 final rule, EPA believes reporting on certain activities may be unnecessary for the reasons articulated in this preamble. In addition, EPA believes some byproduct reporting may be duplicative. See the relevant discussions in Unit III for more detail.
• TSCA section 8(a)(5)(B) directs the Agency, to the extent feasible, to minimize cost of compliance on small manufacturers. Under TSCA section 8(a), a "small manufacturer" is a manufacturer that either has revenues less than $120 million and manufactures less than 100,000 pounds in production volume for a chemical substance or has revenues less than $12 million regardless of production volume annually.
• TSCA section 8(a)(5)(C) directs the Agency, to the extent feasible, to apply reporting obligations to only those persons likely to have information relevant to the effective implementation of TSCA.

EPA has also reconsidered the scope of the reporting requirements in light of TSCA section 2(c), which directs the Agency to carry out TSCA "in a reasonable and prudent manner" and to "consider the environmental, economic, and social impact of any action." See Chem. Mfrs. Ass'n v. EPA, 899 F.2d 344, 347-48 (5th Cir. 1990) ("Congress [ ] plainly intended the EPA to consider the economic impact of any actions taken by it under the TSCA") (citing 15 U.S.C. 2601(c); emphasis in original); see also Nat'l Ass'n of Home Builders v. EPA, 682 F.3d 1032, 1039 (D.C. Cir. 2012); Ausimont U.S.A. Inc. v. EPA, 838 F.2d 93, 95 (3d Cir. 1988). Unlike certain other TSCA provisions, section 8(a)(7) does not direct EPA how to use the information collected under the PFAS reporting rule. In contrast, for example, TSCA section 8(b)(10) directs EPA to promulgate a rule "to assist in the preparation of" an inventory of mercury supply, use, and trade in the United States." The stated purpose of TSCA section 8(b)(10) data collection is to create a mercury inventory and to recommend actions to achieve mercury use reduction. See NRDC, Inc. v. EPA, 961 F.3d 160, 175 (2d Cir. 2020) ("Congress's instruction to EPA to create and publish `an inventory of mercury supply, use, and trade, in the United States,' evinces its affirmative interest in cataloguing both the nature and extent of mercury use in the United States economy. Congress made clear that it intends EPA to collect and publish information on mercury use."). TSCA section 8(a)(7) does not specify any such use for the data collection. EPA also notes that commenters on the TSCA section 8(a)(7) proposed rule stated that its associated burden was disproportionate to the benefits that would be derived from the data collected under the rule. EPA has reconsidered its position and, consistent with TSCA sections 2(c) and 8(a)(5), proposes to exempt certain activities from the rule given the lack of express statutory directive to create a full inventory of all PFAS manufacturing activities.

Although EPA now believes information on certain reportable activities is not necessary at this time, the Agency may in the future determine that such information is necessary to support particular regulatory actions. Courts have supported such a sequenced process to addressing an Agency's statutory obligations. See S. Coast Air Qual. Mgmt. Dist. v. EPA, 554 F.3d 1076, 1080 (D.C. Cir. 2009); Bluewater Network v. EPA, 372 F.3d 404, 411 (D.C. Cir. 2004). Here, it is reasonable to defer the collection of certain information until there is a clear role that such information could play to support a program mission of the Agency. TSCA grants EPA adequate authority to secure such information as needed, including under TSCA section 8, should the information collected sunder TSCA section 8(a)(7) prove insufficient or outdated for a particular action.

E. What are the estimated incremental impacts of this action?

EPA has prepared an Economic Analysis of the potential impacts associated with this proposed rule (Ref. 1). The primary purpose of this proposed rule is to incorporate certain exemptions to the scope of reportable manufacturing activities for PFAS manufactured from 2011 to 2022, as required under TSCA section 8(a)(7).

This proposed action would reduce the burden on entities least likely to know and report relevant information without sacrificing the known and reasonably ascertainable data related to historically manufactured PFAS. Through the proposed exemptions and other clarifications to the regulation, this action is expected to provide both regulatory relief and greater regulatory certainty to regulated parties, resulting in a net reduction in cost while retaining the majority of PFAS manufacture reporting requirements.

The reporting community is expected to receive burden reductions from the proposed amendments to the PFAS reporting rule associated with rule familiarization, compliance determination, form completion, and recordkeeping activities. EPA is also accounting for the sunk costs of companies that have undertaken some level of rule familiarization and compliance determination when estimating the expected reduction in costs. EPA estimates that approximately 6-12 percent of the expected costs of the October 11, 2023, TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP) have already accrued. This estimate is based on best professional judgment; see Unit IV.B for additional discussion and requests for public comments on this estimate. Under the proposed rule, EPA estimates a total industry burden reduction of 10-11. million fewer total hours, or a cost savings of $786-$843 million compared to the October 11, 2023, TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP) requirements. Affected small businesses are expected to be relieved of 9.3-9.9 million total hours, or $703-$761 million in costs. The Agency is not expected to incur incremental costs. The total incremental social cost savings of the proposed rule compared to the October 11, 2023, TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP) is therefore estimated to be approximately $786-$843 million.

F. Severability

EPA intends that the provisions of this proposed rulemaking would, if finalized, be severable from one another. In the event that any individual provision or part of this rulemaking is invalidated, EPA intends that this would not render the entire rulemaking invalid, and that any individual provisions that are finalized would continue to be followed.

II. Background

A. TSCA Section 8(a)(7)

President Trump signed into law the National Defense Authorization Act for Fiscal Year 2020 (NDAA) on December 20, 2019 (Pub. L. 116-92). Among other provisions, section 7321 of the NDAA created TSCA section 8(a)(7). TSCA section 8(a)(7) states that the Administrator "shall promulgate a rule in accordance with this subsection requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011, to submit to the Administrator a report that includes, for each year since January 1, 2011, the information described in subparagraphs (A) through (G) of paragraph (2)." The categories of information described in sections 8(a)(2)(A) through (G) are:

• The common or trade name, chemical identity and molecular structure of each chemical substance or mixture for which a report is required;
• Categories or proposed categories of use for each substance or mixture;
• Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
• Descriptions of 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, and reasonable estimates on the number of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure; and
• The manner or method of disposal of each substance or mixture, and any change in such manner or method.

B. The PFAS Data Reporting Rule Under TSCA Section 8(a)(7)

On June 28, 2021, EPA proposed the TSCA section 8(a)(7) PFAS reporting rule (86 FR 33926) (FRL-10017-78). This rule proposed to require any person who had manufactured (including imported) a PFAS (including as a mixture or an article containing a PFAS) as defined by a structural definition to report the required information for each year from 2011 to 2022 (86 FR 33926, June 28, 2021) (FRL-10017-78), to the extent such information is known to or reasonably ascertainable by the manufacturer. EPA did not propose any reporting exemptions or thresholds that other TSCA reporting rules have used, such as for chemical substances in imported articles, R&D chemicals, impurities, and certain byproducts. Additionally, EPA proposed no flexibilities for small manufacturers.

After a 90-day public comment period and additional information gathering on the proposed rule's burden and cost estimates, EPA could not support a certification under the Regulatory Flexibility Act (RFA) that the rule would impose no significant economic impact on a substantial number of small entities. EPA thus convened a Small Business Advocacy Review (SBAR) Panel in April 2022. The Panel used feedback from small entity representatives to develop a Panel Report (Ref. 2) and Initial Regulatory Flexibility Analysis (IRFA) (Ref. 3). EPA opened a second public comment period (87 FR 72439) (FRL-7902-04-OCSPP) on November 25, 2022, to solicit comment on the proposed rule's IRFA, SBAR Panel Report, and other aspects of the proposed rule that may have been impacted by EPA actions or proposed actions after the proposed rule's publication in June 2021.

EPA considered comments and other stakeholder input, including from the SBAR Panel, in developing the final rule, which was published on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP). Public input informed changes from the 2021 proposed rule, including the scope of the PFAS structural definition, the duration of the data submission period, and the inclusion of shorter reporting forms for certain PFAS manufacturing scenarios. However, EPA did not add any exemptions as requested by commenters and as recommended by the SBAR Panel.

The final rule established a 12-month data collection period for manufacturers following the effective date of the rule, followed by a six-month data submission period, with information from most PFAS manufacturers due to EPA by May 8, 2025. Small manufacturers reporting exclusively as article importers had a 12-month submission period, with a reporting deadline of November 10, 2025.

C. Implementation Status of the PFAS Data Reporting Rule

Data have not yet been submitted under the PFAS reporting rule. Since promulgating the final rule on October 11, 2023, the Agency has moved the reporting deadline twice. EPA needed to move the submission period due to the delay in the development of the reporting application on EPA's Central Data Exchange (CDX, the Agency's electronic reporting site), related information technology (IT) infrastructure challenges, and the ability to conduct user testing data needed for IT reporting application development. On September 5, 2024, EPA promulgated a direct final rule (89 FR 72336) (FRL-7902.1-02-OCSPP) to move the start of the data submission period from November 12, 2024, to July 11, 2025. EPA subsequently published an interim final rule on May 13, 2025 (90 FR 20236) (FRL-7902.2-01-OCSPP) to move the start of the data submission period from July 11, 2025, to April 13, 2026. EPA noted the need for such amendments due to further delays in developing the CDX infrastructure and conducting industry beta testing to ensure the reporting application collects and stores data as intended.

III. Proposed Amendments

A. Proposed Exemptions

EPA is proposing to add certain exemptions to the scope of reportable PFAS manufacturing activities under 40 CFR 705. EPA intends these exemptions to be similar to the TSCA Chemical Data Reporting (CDR) rule (40 CFR 711) and, in addition, proposes to include the de minimis exemption described in Unit III.A.1. In some scenarios, more than one of these proposed exemptions may provide the same regulatory relief from reporting. For example, an importer of articles which contain low levels of PFAS may be exempt from reporting by virtue of both the imported articles and de minimis exemptions. EPA is interested in public comments on potential means to consolidate the proposed exemptions, while providing the same regulatory relief and in public comments on the potential benefits and drawbacks of finalizing all proposed exemptions or a subset of proposed exemptions when viewed in combination.

The purpose of this rule is to better understand the PFAS manufactured (including imported) in the United States for commercial purposes, to the extent the information is known to or reasonably ascertainable by regulated entities. EPA recognizes that the number of entities that will need to search their records to identify the information is greater than the number of entities that will ultimately report. In EPA's 2023 Economic Analysis (Ref. 4) and FRFA (Ref. 5), the Agency assumed that, of all small article importers conducting due diligence to identify any reportable PFAS, only 10% would ultimately determine that they had known or reasonably ascertainable information to report on PFAS imported in articles. That is, 90% of the small article importers would be burdened by compliance determination activities only to then determine that they do not need to report because the information is not known or reasonably ascertainable.

After further consideration of the Agency's obligations under TSCA sections 8(a)(7), 8(a)(5), and 2(c), EPA is reassessing whether the volume of potential data collected justifies the total burden of implementing that collection and what result Congress intended when it added TSCA section 8(a)(7) within the broader structure of section 8. Therefore, EPA is proposing these exemptions to maintain meaningful reporting on PFAS while exempting regulated entities that are least likely to have relevant information, alleviating some compliance burden ( e.g., rule familiarization, recordkeeping), and eliminating some reporting where EPA has now determined that the reportable information is unnecessary to fulfill statutory obligations. These proposed exemptions also aim to minimize, to the extent feasible, the burden of regulatory compliance on small manufacturers, pursuant to TSCA section 8(a)(5)(B). These proposed exemptions are responsive to the agency's obligations under the Regulatory Flexibility Act and are consistent with several of the recommendations that were made in the 2022 SBAR Panel Report (Ref. 2). EPA estimates that with these proposed exemptions, small businesses subject to the October 11, 2023, final rule (88 FR 70516) (FRL-7902-02-OCSPP) would be relieved of over $703-$761 million in net regulatory compliance burden.

1. De Minimis

EPA is proposing a de minimis concentration exemption for reportable PFAS in mixtures or articles under which PFAS concentrations below 0.1% would be exempt from reporting. This low-concentration exemption would apply regardless of total production volume of the mixture or article. Implicit in most statutes is the authority for an implementing agency to exempt de minimis concentrations from the scope of general rules. "[T]he venerable maxim de minimis non curat lex ("the law cares not for trifles") as part of the established background of legal principles against which all enactments are adopted, and which all enactments (absent contrary indication) are deemed to accept." Wis. Dep't of Revenue v. William Wrigley, Jr., Co., 505 U.S. 214, 231 (1992); Citadel Sec. v. SEC, 45 F.4th 27, 36 (D.C. Cir. 2022) (explaining that an agency decision was reasonable and supported by the maxim); Shays v. Federal Election Commission, 414 F.3d 76, 113-14 (D.C. Cir. 2005) ("Predicated on the notion that the Congress is always presumed to intend that pointless expenditures of effort be avoided, such authority is inherent in most statutory schemes, by implication.") (internal quotation marks omitted); Ober v. Whitman, 243 F.3d 1190, 1194 (9th Cir. 2001); EDF, Inc. v. EPA, 82 F.3d 451, 466-467 (D.C. Cir. 1996). This principle only covers situations where "the burdens of regulation yield a gain of trivial or no value." EDF, 82 F.3d at 466.

EPA proposes to apply the de minimis principle here because nothing in TSCA section 8 suggests an intent to depart from this background rule of construction. Nor is the statutory language in TSCA section 8(a)(7) so uncompromisingly rigid as to preclude a de minimis exemption. Under TSCA section 8(a)(7), EPA must gather information from manufacturers of PFAS, but TSCA section 8(a)(5) grants EPA broad authority to reduce the burdens of such reporting to the extent feasible by placing the "PFAS Data" paragraph within TSCA section 8, Congress intended this authority to apply. Also, as noted above in Unit I.D., Congress indicated a practical intent for implementation of TSCA-the statute shall be carried out "in a reasonable and prudent manner." 15 U.S.C. 2601(c). A de minimis exemption is a reasonable and familiar means to achieve such ends.

The proposed de minimis level of 0.1% is appropriate because of the retrospective nature of the reporting and contemporary recordkeeping practices. During the lookback period for reporting, reporters are unlikely to have records of PFAS amounts below 0.1% due to U.S. and international requirements at the time, e.g., for labeling and recordkeeping. During the development of the 2023 final rule, several commenters and small entity representatives described the challenges of determining the presence of a PFAS in past imports when the concentration would have been below the Safety Data Sheet (SDS) or the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) notification levels ( see docket comments EPA-HQ-OPPT-2020-0549-0054, 0105, 0107, 0139, 0163, and 0165). Suppliers covered under SDS and REACH notification requirements need not provide notification of PFAS levels below 0.1% under the most stringent chemical hazard classifications. Without REACH notifications having required notice for PFAS below 0.1% of a mixture or an article during the retroactive reporting time frame, companies would not have known that they have manufactured (including imported) PFAS below that de minimis concentration. See 15 U.S.C. 2607(a)(5)(C). Additionally, the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (29 CFR 1910.1200) sets cut-offs for the minimum concentration of a chemical that triggers requirements for an SDS. The cut-off level of 0.1% is generally applied to chemicals classified as "health hazards" and a chemical is classified as a health hazard if it poses certain hazardous effects. Health hazards include, among others, chemicals that are carcinogens, reproductive toxins, irritants, and sensitizers (29 CFR 1910.1200(c) and Appendix A). Some evidence suggests that exposure to certain PFAS may lead to adverse health effects, including an increased risk of some cancers, as identified in the EPA's National PFAS Testing Strategy (Ref. 6). Identifying whether a mixture or article contains PFAS below 0.1% would be time consuming and complicated because PFAS were not required to be reported on an SDS during the relevant lookback period.

EPA also considered potential impacts of other statutory or regulatory requirements pertaining to de minimis levels of PFAS that were in effect during the 2011-2022 reporting period, to the extent those requirements may impact manufacturers' knowledge of and ability to report on manufacturing of de minimis concentrations in mixtures and articles. During most of the lookback period, there were few international labeling or notification requirements for small concentrations of PFAS. As public commenters previously noted, the REACH regulation in the European Union only placed certain groups of PFAS on their Substances of Very High Concern (SVHC) Candidate List beginning in 2019, with HFPO-DA and its salts (Ref. 7). These listings triggered additional legal obligations, including safety communication to customers, when articles contain an SVHC at concentrations above 0.1% (Ref. 8). Thus, it is unlikely that manufacturers would have been able to identify such small concentrations of PFAS in mixtures and articles during this rule's reporting period. As suppliers were not obligated to disclose de minimis levels of PFAS, those manufacturers likely would not know of the existence of such PFAS and render those mixtures and articles not known or reasonably ascertainable under TSCA Section 8(a)(5).

Moreover, a uniform 0.1% de minimis threshold would relieve manufacturers of burden related to investigating the relevant exemption level and applying different concentrations to different PFAS. The OSHA Hazard Communication Standard for chemicals not classified as a "health hazard" uses a cut-off concentration of 1.0% by weight, and the extent to which many PFAS present health concerns similar to those relatively few PFAS known to be "health hazards" is unclear. Although most PFAS are not classified as health hazards under 29 CFR 1910.1200, EPA is proposing a universal de minimis concentration exemption of 0.1% for all PFAS to reduce the burden of determining which concentration is applicable to each reportable PFAS. Further, PFAS are typically present at low concentrations in mixtures, so a 1% de minimis threshold may remove otherwise reportable information from the scope of the rule. In part, this rulemaking is designed to identify and address available information gaps involving PFAS, so EPA believes that applying a lower, uniform 0.1% de minimis concentration threshold for all reportable PFAS helps address information gaps where information exists and still alleviates burden by providing a de minimis threshold.

EPA also considered establishing de minimis levels based on detection limits in validated analytical methods developed by EPA. As of August 2025, EPA has developed analytical methods for the detection of dozens of PFAS in various environmental media (see https://www.epa.gov/water-research/pfas-analytical-methods-development-and-sampling-research ). However, EPA identified several limitations to this potential approach to such an exemption. First, the number of PFAS that have at least one analytical method is a small portion of the broader universe of known PFAS. The detection limits associated with those PFAS with analytical methods are also at different levels, varying by orders of magnitude. Further, some of the lowest detection limits (in parts per trillion) would render any exemption based on concentrations below such limits ineffectual. EPA ultimately determined that basing a proposed de minimis exemption level on these analytical methods would be inappropriate. As noted in Unit IV, EPA seeks comment on the proposed 0.1% de minimis level, including information on what concentration level other than 0.1% might be appropriate for an exemption.

EPA also proposes to exempt these de minimis concentrations of PFAS in mixtures and articles (see Unit III.A.2.) from the scope of the rule based on the Agency's information needs under TSCA section 8(a)(5)(A). The Agency has determined that information about such PFAS in mixtures is unnecessary, in part because EPA does not anticipate publishing an "inventory" of all PFAS manufactured since 2011 such that EPA would need a complete reporting of all PFAS in U.S. markets. Compare 15 U.S.C. 2607(a)(7) with 15 U.S.C. 2607(b)(10). Additionally, EPA does not anticipate evaluating PFAS that may only be manufactured in de minimis levels in the near future under TSCA (see 2024 TSCA section 8(d) rule ((89 FR 100756, 100758, December 13, 2024) (FRL-11164-02-OCSPP). Manufacturers that report pursuant to this rule are required to provide downstream processing and use information about the use of PFAS in consumer and commercial products, including articles. Thus, despite the provision of de minimis and imported article exemptions (discussed below), EPA anticipates it will receive information on low concentrations and articles from original manufacturers of PFAS who are most likely to have such information and who are likely to report pursuant to this rule should the proposed exemptions be finalized. Such information from these manufacturers will help the Agency identify situations in which more information about PFAS in articles may be necessary, and EPA will address such needs when they are identified.

2. Imported Articles

EPA is proposing to exempt PFAS imported as part of an article from the scope of reportable activities (see proposed 40 CFR 705.5, 705.12, 705.18, and 705.30). An "article" is defined in 40 CFR 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; except that fluids and particles are not considered articles regardless of shape or design."

EPA recognizes that importing PFAS in articles between 2011-2022 is an activity about which manufacturers are unlikely to have known or reasonably ascertainable information. As discussed above, SDS and REACH notification requirements are not likely to have revealed the content of PFAS in imported articles during the time span covered by this retroactive reporting rule, which is a perspective shared widely by commenters and the small entity representatives to the SBAR Panel (87 FR 72439, November 25, 2022) (FRL-7902-04-OCSPP). Thus, importers of articles across many industries have the burden of reviewing any past SDSs or other records, such as REACH notifications, for confirmation that PFAS has been imported in those articles. EPA has now reconsidered the weight of that input and now proposes to exempt importing articles in an effort to apply reporting obligations, to the extent feasible, to those persons likely to have information (TSCA section 8(a)(5)(C)).

Should EPA finalize this proposal by exempting the reporting on PFAS in imported articles, the Agency will nevertheless receive information on the incorporation of PFAS in articles. The rule requires manufacturers to report on processing and use (both industrial and consumer/commercial) for their manufactured PFAS, such as any incorporation in articles (40 CFR 705.15(c)). The processing and use reporting requirements will inform the Agency's understanding of which PFAS are used in various types of industrial processes or consumer and commercial products, which will be instructive to future TSCA actions.

EPA is also proposing this imported articles exemption under TSCA section 8(a)(5)(A), as the Agency finds that requiring retroactive reporting on importing articles with PFAS is unnecessary (in addition to EPA finding that requiring reporting from importers of articles containing PFAS exceeds EPA's authority under TSCA Section 8(a)(7), see the below paragraph). On balance, EPA finds it unnecessary to require reporting for this activity and impose related non-reporting burden activities such as rule compliance determination and due diligence record searches when such importers are unlikely to have relevant information.

In addition, EPA proposes that requiring reporting from importers of articles containing PFAS exceeded EPA's authority under TSCA section 8(a)(7). In the NDAA, Congress directed the EPA to require reporting from "each person who has manufactured a chemical substance that is a [PFAS]. " 15 U.S.C. 2607(a)(7) (emphasis added). As a general matter, TSCA section 3(2)(A) defines "chemical substance" as "any organic or inorganic substance of a particular molecular identity," including natural combinations, elements, and uncombined radicals. TSCA section 3(9) defines "manufacture" to include production, manufacture, and imports. By specifying "a chemical substance that is a [PFAS]," in TSCA section 8(a)(7), however, Congress provided that the reporting requirement would apply to a narrower universe than TSCA would generally cover.

Specifically, EPA proposes to conclude that the NDAA is best read as excluding articles and targeting the reporting requirement to manufacturers of the PFAS themselves. Had Congress intended the legislation to include articles that contain a PFAS substance, it could have said so. Here, Congress chose to target manufacturers (including importers) of the PFAS themselves, as indicated by the specific phrase "that is a" (instead of a more inclusive term such as "contains"). Where Congress omits expansive modifiers, they should not be inferred. EPA is soliciting feedback on this argument, which was raised by commenters on the June 2021 proposed rule (86 FR 33926) (FRL-10017-78). Since EPA is proposing to exempt article importers under TSCA section 8(a)(5) as discussed above, this rationale would lead to the same outcome in terms of regulatory requirements.

3. Byproducts, Impurities, and Non-Isolated Intermediates

EPA is proposing to exempt the manufacture of PFAS as byproducts, impurities, non-isolated intermediates, or upon incidental exposure, or end use of another substance or mixture from the scope of reportable activities when such substances are manufactured under conditions described in 40 CFR 720.30(h). These proposed exemptions align with existing exemptions under TSCA for substances not manufactured and used for a separate commercial purpose and is consistent with the approach taken in EPA's CDR rule (see 40 CFR 711.10(c)).

EPA describes the byproduct, impurity, and non-isolated intermediate activity exemptions below. Overall, the exemptions reflect a practical application of TSCA section 8(a)(5)(C), under which EPA shall, to the extent feasible, apply reporting obligations only to those persons likely to have relevant information. EPA has historically exempted such manufacturing activities ( i.e., impurities, non-isolated intermediates, and certain byproducts; manufacturing low quantities solely for R&D purposes) from the scope of reporting obligations under TSCA sections 5 and 8. EPA is not proposing to exempt other types of manufacturing activities, including for byproducts subsequently used for a commercial purpose listed in 40 CFR 720.30(g), as the Agency believes PFAS manufacturers are more likely to have relevant information on those manufacturing activities. As proposed, these exemptions would ensure that manufacturers remain focused on reporting PFAS with greater commercial relevance and potential exposure pathways while relieving industry of disproportionately burdensome reporting. By eliminating the need to search for and report on data related to these manufacturing activities that have been traditionally exempt from other TSCA reporting requirements, manufacturers would avoid resource-intensive record reviews and unnecessary administrative burden for reporting activities unlikely to provide relevant information.

Byproducts. The regulation currently requires a manufacturer of PFAS to report in separate chemical reports each PFAS that is manufactured, without exception. EPA is proposing to exempt from the requirement to report PFAS that are solely manufactured as a byproduct in a manner described in 40 CFR 720.30(h) (see proposed 40 CFR 705.12). Specifically, EPA is proposing to exempt any byproduct not used for commercial purposes. "Byproduct" is defined in 40 CFR 704.3 to mean "a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s)."

EPA is proposing this exemption because it now believes this information is unnecessary to implement its statutory obligations and potentially duplicative. Consistent with TSCA section 8(a)(5)(A), EPA believes it is appropriate to exempt manufacturers of PFAS as a byproduct when they are not used for a commercial purpose. EPA does not find that the reportable information on PFAS manufactured as byproducts and without subsequent commercial use is necessary, considering the Agency's ongoing obligations under TSCA are limited to specific PFAS, not the entire class, and because of the expected low exposure potential to such non-commercial PFAS. However, EPA is interested in learning about the intended commercial uses of PFAS, including PFAS when manufactured as a byproduct, and thus is not proposing to exempt manufacture of PFAS as a byproduct if it is used for a commercial purpose. Further, this proposed byproduct exemption would apply only to the byproduct. The exemption does not apply to component substances extracted from a byproduct, when the extracted substances are reportable PFAS.

For certain reporting requirements ( e.g., CDR), EPA has exempted manufacture of byproducts for specific types of commercial purposes (see proposed 40 CFR 720.30(g)). For this rule, EPA is not proposing to exempt PFAS manufactured as byproducts that are used for a commercial purpose as listed at 40 CFR 720.30(g). These types of commercial purposes may provide relevant information on exposure pathways of interest to EPA, such as applying PFAS-containing wastes to land for soil enrichment or when burned as a fuel (Ref. 9).

This proposed exemption does not impact the need to report information about any byproducts resulting from the manufacture, processing, use, or disposal of each reportable PFAS under 40 CFR 705.15(e), consistent with the requirement under TSCA section 8(a)(2)(D). If you are reporting the manufacture of a PFAS with byproducts produced during the manufacture, processing, use, or disposal of that PFAS, you must report basic information ( e.g., chemical identity, related PFAS activity, volume, and environmental releases) about the byproducts. That is, a manufacturer of a non-byproduct PFAS will provide information on all byproducts produced while manufacturing, processing, using, or disposing of the given PFAS ( e.g., polytetrafluoroethylene (PTFE) is a reportable PFAS and reporting on PTFE where "GenX chemicals" were created as a byproduct in the production of PTFE would result in reporting on PTFE including information on the manufacture of GenX chemicals as PTFE's byproduct (see Ref. 10 for more information on GenX chemicals)).

EPA notes that pursuant to this proposed exemption, the Agency will not receive reporting on PFAS manufactured as byproducts of a non-PFAS. In addition, under the 2023 final rule, a processor would need to report as a manufacturer for any PFAS-containing byproducts; with this proposed exemption, such reporting would not occur unless the byproducts have a separate commercial use.

EPA further believes reporting on PFAS manufactured as byproducts in the manner described at 40 CFR 720.30(h) may be duplicative of the requirements to report on any byproduct produced during the manufacture, processing, use, or disposal of a reportable PFAS. As described above, if a PFAS is manufactured as a byproduct during the manufacture, processing, use, or disposal of a reportable PFAS, EPA would receive information that is known or reasonably ascertainable on that byproduct, including the chemical identity and the amounts released to different environmental media. Given the scope of the definition of PFAS under 40 CFR 705.3, many fluorinated substances (including their potential byproducts) are captured such that reporting on those fluorinated byproducts would be identified and reported on in the precursor PFAS's report.

EPA has determined that information related to PFAS manufactured as byproducts without separate commercial uses, under the same conditions that are exempt from CDR, is unnecessary and potentially duplicative. Accordingly, EPA is proposing this activity exemption under section 8(a)(5)(A).

Impurities. EPA is proposing to exempt the manufacture of PFAS as impurities from the scope of reportable activities, as described in 40 CFR 720.30(h)(1) (see proposed 40 CFR 705.12). This exemption is also incorporated in the CDR regulation (see 40 CFR 711.10(c)). As defined at 40 CFR 704.3, an impurity is a chemical substance unintentionally present with another chemical substance. Impurities are not manufactured for distribution in commerce as chemical substances per se, and they have no distinct commercial purpose apart from the substance, mixture, or article in which they are contained.

EPA proposes that, consistent with TSCA section 8(a)(5)(A), requiring this information is unnecessary. As explained in CDR guidance ( see Ref. 11), in evaluating whether a PFAS is an impurity, EPA considers the source of the substance in the manufacturing process. A substance that arises unintentionally in a final product because it was introduced unintentionally as a component of a raw material, it may be considered an impurity. This is distinguishable from a byproduct, which is a substance formed as part of the intended chemical reaction or byproduct stream and intentionally retained would not meet the definition of an impurity and may be subject to reporting. EPA understands there are likely no PFAS manufactured as impurities domestically, as PFAS are not likely to be unintentionally present in raw materials introduced into a process. Thus, the manufacturing of PFAS as impurities would only derive from the import of materials with PFAS as impurities. Such importers are not likely to know about the presence of PFAS, let alone any reportable information under section 8(a)(7). Therefore, exempting manufacturers (including importers) of impurities would not meaningfully impact the scope of the universe of manufacturers of PFAS impurities who would have relevant information to report under this rule. Such an exemption would therefore be consistent with TSCA section 8(a)(5)(C), which requires EPA to, to the extent feasible, extend reporting obligations to those likely to have relevant information. Without relevant information to report under this rule, EPA has determined that exempting the manufacture of PFAS as impurities is appropriate. EPA is seeking public comment on this proposed exemption to ensure that the definitions and exemption conditions of byproducts and impurities are consistently and appropriately applied to PFAS manufacturing activities.

Non-isolated intermediates. Consistent with the proposed exemptions to align with 40 CFR 720.30(h), EPA is proposing to exempt otherwise-reportable PFAS that are non-isolated intermediates (see proposed 40 CFR 705.12). Non-isolated intermediates, as defined at 40 CFR 704.3, are substances manufactured and consumed within a closed system during the production of another chemical substance. These intermediates are not intentionally removed from process equipment, such as reaction vessels or continuous flow systems, and are not stored, packaged, or transported. Because these substances remain confined within closed systems and are not expected to be released in the environment or handled by workers, EPA has determined that reporting on non-isolated intermediates is unnecessary because these intermediates do not result in meaningful human or environmental exposure. EPA is proposing this exemption consistent with TSCA section 8(a)(5)(A). Additionally, as described earlier in Unit III.A.3., manufacturers have generally not been required to submit reports related to the manufacture of non-isolated intermediates under TSCA. The Agency has exempted non-isolated intermediates in the past, in part, because such substances often are extremely difficult to identify. See 15 U.S.C. 2607(a)(5)(C).

4. Research and Development (R&D) Chemicals

EPA is proposing to exempt PFAS manufactured (including imported) in small quantities for R&D purposes (see proposed 40 CFR 705.12). The proposed exemption, while limited to PFAS manufactured solely for R&D purposes, has no threshold limit. EPA notes that such quantities manufactured solely for R&D purposes are quantities no greater than reasonably necessary for those R&D activities (see 40 CFR 704.3, which defines small quantities for research and development as "quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes").

Based on stakeholder input, EPA understands that information on PFAS manufactured solely for R&D purposes would be limited and would provide minimal information regarding PFAS exposures and quantities in commerce, which were the focuses of TSCA section 8(a)(7). EPA does not see such information as improving the Agency's understanding of the exposures and potential risks of such PFAS under TSCA. Pursuant to TSCA section 8(a)(5)(A), EPA has determined information about such chemicals is unnecessary. EPA may consider future data calls for R&D chemicals if the Agency determines a need to do so.

Further, other TSCA reporting requirements have incorporated exemptions of small quantities of R&D chemicals consistent with the definition at 40 CFR 704.3 (for example, TSCA section 5 new chemicals reporting (see 40 CFR 720.30(c)), inventory reporting (see TSCA section 8(b)(1)), and CDR reporting (see 40 CFR 711.10(a)). Without a historical need to provide reporting on PFAS manufactured in small quantities solely for R&D purposes under both TSCA section 5 and other section 8 actions, EPA believes manufacturers of such R&D PFAS will be unlikely to have information responsive to the data request under TSCA section 8(a)(7). Therefore, exempting such manufacturers is consistent with EPA's obligations under TSCA section 8(a)(5)(C) to apply reporting requirements to only those persons likely to have such relevant information.

Exempting PFAS manufactured solely for R&D purposes is also consistent with EPA's obligations under TSCA section 8(a)(5)(B), to minimize, to the extent feasible, the cost of compliance with TSCA section 8 rules on small manufacturers. In the SBAR Panel conducted for this rule in 2022 (see Unit II.B.), EPA learned from a small entity representative that their small business manufactured PFAS for laboratory and analytical purposes and is not generally subject to TSCA reporting requirements. Under this proposed exemption, EPA will minimize compliance costs on such small manufacturers pursuant to TSCA section 8(a)(5)(B).

This exemption is also being proposed pursuant to the Administration's priorities as outlined in Executive Order 14219, which seeks to reduce regulations that impose costs that "impede" R&D and economic development activities. Based on input from manufacturers (for example, comments EPA-HQ-OPPT-2020-0549-0069, 0084, and 0143), the requirement to report on typically exempt R&D substances, even in a streamlined reporting form with fewer required data fields, would impose significant burden on manufacturers who may have up to thousands of small quantity R&D substances, whose R&D staff would need to assist with the efforts to respond to this rule, including by searching through "potentially hundreds of lab notebooks" (comment EPA-HQ-OPPT-2020-0549-0143). Exempting PFAS manufactured in small quantities solely for R&D activities alleviates the compliance burden on those stakeholders conducting commercial R&D and other economic development activities and provides more resources to carry out such activities.

B. Submission Period

EPA is proposing to amend the data submission period to accommodate the changes to the reporting scope in this proposal. EPA believes a shift to the data submission period is appropriate when the reporting regulation has changed. This allows reporters to familiarize themselves with the amended rule and ensure their data are responsive to the amended rule and EPA to modify the reporting application as needed, such as removing the option of streamlined reporting forms for article importers and R&D manufacturers.

EPA proposes to alter the submission period as follows: the submission period will begin 60 days after the effective date of the final rule and will last for three months (see proposed 40 CFR 705.20). The time EPA took to develop the 2023 final rule and engage with stakeholders on the content of the rule, as well as the time that has passed since promulgation of the 2023 final rule, suggests to the Agency that reporters have had adequate time to consider how they intend to comply with the rule. Because no reporting will be required from article importers due to the proposed exemption (see Unit III.A.2.), EPA proposes to remove the reporting deadline for small manufacturers who would report under this rule exclusively as article importers.

C. Clarifications and Technical Corrections

1. Scope of Environmental and Health Effects Information

The current rule requires the submission of exposure-related information and "all existing information concerning the environmental and health effects" of the chemical substances covered by this rule. "All existing information concerning environmental and health effects" is defined as "any information of any effect of a chemical substance or mixture on health or the environment or both" (40 CFR 705.3) and is intended to be interpreted broadly. In addition, certain information is required to be reported using the OECD-harmonized template (OHT) format. EPA proposes to clarify the requirements related to reporting using the OHT format, including to propose a regulatory change to confirm that OHTs are required for unpublished study reports on the environmental and health effects of the reportable PFAS, except for exposure information provided in the fielded data elements throughout the reporting application.

In Unit III.E of the 2023 final rule, EPA described the need to submit all existing information concerning health and environmental effects in the OHT format, where such templates exist for the type of data reported (40 CFR 705.15(f)). To avoid duplicative reporting, EPA proposes to clarify that the use of OHTs is not required for exposure-related information otherwise reported in the fielded data elements (40 CFR 705.15(b)-(e) and (g)-(h)). See proposed amendments to 40 CFR 705.15(f)(1). EPA did not quantify the burden associated with this proposed regulatory text change. EPA is seeking public comment on the OHT requirement for environmental and health effect information and associated burden.

2. Consumer and Commercial Product Categories

EPA is proposing to update the names used for specific consumer and commercial product categories as required under 40 CFR 705.15(c)(4). Like the clarification above, this proposed change would not alter any reporting requirements or introduce new burden but rather aims to clarify existing requirements. EPA has received requests for clarification from data submitters under the CDR regulation, which uses the same product category names, so EPA proposes to clarify the names and descriptions for the same consumer and commercial article-related codes in the PFAS Data Reporting Rule (see Table 5 at 40 CFR 705.15(c)(4)). For example, under CC303, EPA proposes to add "Articles without routine direct contact, such as" to the associated name to better define the difference between CC303 and CC304, which has been confusing for some CDR data submitters. In addition, EPA is proposing to revise the product category code names associated with CC217 through CC221 and CC305 to more clearly identify the types of articles and materials covered within those categories. See Table 1 below for a comparison between the proposed and existing impacted product category codes and names. Table 1. also includes descriptions for each code, which EPA provides in reporting guidance. The proposed changes eliminate the overlap between the categories and reduce reporter uncertainty regarding the correct category to report.

IV. Requests for Comment

EPA requests comment on the content of this proposed rule and the Economic Analysis prepared in support of this proposed rule (Ref. 1). In addition, EPA is providing a list of issues on which the Agency is specifically requesting public comment. EPA encourages all interested persons to submit comments on the topics raised in this proposal. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the regulation. EPA requests that commenters include materials supporting their rationale to the extent possible.

1. As described in Unit III.A.1., EPA is soliciting comment on the proposed 0.1% de minimis exemption for PFAS in mixtures and articles. EPA is also interested in comments on a 1.0% de minimis exemption for PFAS in mixtures and articles instead of the proposed 0.1% de minimis exemption, or another appropriate de minimis level.

2. As described in Unit III.A.2, EPA is soliciting comment on an imported articles exemption. EPA is also interested in comments on the Agency's reconsidered interpretation of the statutory language of the NDAA and whether the NDAA is best read as excluding articles from the scope of reporting.

3. As described in Unit III.A.3, EPA is soliciting comment on exempting certain byproducts, impurities, and non-isolated intermediates by incorporating the exemptions at 40 CFR 720.30(h). This exemption would extend to PFAS that are manufactured upon incidental exposure or end use of another substance or mixture based on conditions described in 40 CFR 720.30(h)(3)-(7).

4. As described in Unit III.A.4, EPA is soliciting comment on an exemption for manufacturing PFAS in small quantities for R&D activities.

5. As described in Unit III.B, EPA is soliciting comment on whether the Agency's proposed amendment to the data submission period is appropriate to accommodate the proposed changes to the PFAS Data Reporting Rule.

6. As described in Unit III.C.1, EPA is soliciting comment on the requirements related to reporting using the OHT format, including to propose a regulatory change to confirm that OHTs are required for unpublished study reports on the environmental and health effects of the reportable PFAS, except for exposure information provided in the fielded data elements throughout the reporting application. EPA has not quantified and is also soliciting comment on the potential burden with the OHT requirement for unpublished study reports under 40 CFR 705.15(f). Additionally, in response to stakeholder requests that EPA has received, EPA is soliciting comment on whether to maintain the requirement for full study reports under 40 CFR 705.15(f) or to provide an option for a submitter to provide a robust study summary in lieu of the full study report, with the submitter to provide the full study report upon reasonable EPA request, such as when technical concerns about the data or methodology as described in the summary are identified or the Agency deems that the summary is not robust. EPA continues to maintain its position that full study reports are necessary; however, the Agency is amenable to receiving further perspectives on this topic to further inform its understanding of stakeholder concerns.

7. EPA is soliciting comment on the nature and extent of any reliance interests that may have arisen from the October 11, 2023, TSCA section 8(a)(7) final rule.

In addition to the topics listed above and proposed in this action, EPA is also soliciting comment on specific questions discussed below in this Unit.

A. Should EPA amend the scope of reportable chemicals?

EPA is not proposing changes to the scope of reportable chemical substances but is soliciting comment on this topic. EPA is receptive to feedback on a possible means to lower burden by modifying the scope of reportable substances, such as by limiting reporting to those PFAS with a Chemical Abstracts Service Registry Number (CASRN), or, in the case of a PFAS listed as confidential on the TSCA Inventory, a TSCA Accession Number or Low-Volume Exemption Number. EPA received comments on the 2021 proposed rule and input during the SBAR Panel related to the scope of reportable PFAS, including some requests to codify a discrete list of covered PFAS rather than a structural definition; see, for example, docket comments EPA-HQ-OPPT-2020-0549-0063, 0122, 0165, and 0168, and SBAR Panel Report (Ref. 2). In the final rule published on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP), EPA determined that a structural definition of PFAS was appropriate for this rule. Further, EPA was unable to publicly identify all PFAS on the TSCA Inventory, as some identities have confidentiality claims and currently lack a generic name to indicate that chemical substance is a PFAS. The inclusion of those chemicals on a discrete list for reporting under this rule would not be permitted because that would divulge CBI. Additionally, as chemical innovation has led to new PFAS compounds, limiting the scope of the regulation to certain existing compounds on the TSCA Inventory would create aa gap in the regulation regarding any chemical substances not already on the Inventory. In light of the proposed exemptions outlined in Unit III.A, however, EPA is interested in comments on the scope of reportable substances in this regulation.

Further, EPA has received stakeholder comment recommending a production-volume threshold below which reporting on a given PFAS would not be required. EPA has received feedback from certain stakeholders that a 2,500 lbs. threshold would be appropriate for this rule, as the Chemical Data Reporting Rule provides a 2,500 lbs. threshold for chemical substances subject to specific TSCA activities (see 40 CFR 711.8). However, EPA is not proposing to provide a production-volume threshold. Because this rule aims to provide an understanding of which PFAS have been commercially manufactured in the United States since 2011, and for which uses, EPA does not believe that incorporating a minimum threshold would enable the Agency to meet its information needs. EPA understands that some PFAS that were manufactured in lower quantities may still persist in the environment, and the Agency is interested in understanding the extent of environmental exposure. EPA also notes that there is precedent for promulgating a TSCA rule without a minimum threshold where the regulated chemical(s) are of significant interest to EPA, including due to potential health or environmental concerns.

EPA is amenable to comments regarding the benefits and/or drawbacks of providing such a threshold and what would be an appropriate threshold. EPA would also be interested in comments on whether such a threshold would either make other proposed exemptions unnecessary or impact their scope, e.g., the de minimis threshold.

B. Should EPA modify any assumptions or cost savings calculations in its Economic Analysis?

EPA is specifically seeking comments and data to consider in developing an Economic Analysis for a final rule. In this proposed rule's Economic Analysis (Ref. 1), EPA assumes that 255 manufacturing firms have undergone all compliance determination and rule familiarization activities, and 20,985 article importers have undergone some level of compliance determination and rule familiarization since the promulgation of the final rule on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP). Therefore, EPA estimates that approximately 5% of the estimated total industry cost for the 2023 final rule has already occurred. These assumptions of sunk costs for article importers are based on inquiries EPA has received specifically related to this rule's imported article scope, EPA's expectation that small article importers would be less likely to have completed rule familiarization and compliance determination activities due to their delayed reporting deadline under the 2023 final rule, and EPA's best professional judgement.

In considering the burden reduction this proposed rule would provide, EPA is seeking comment on its assumptions, including on the sunk costs estimates described above and on the assumption that the exemption for article importers and the 26 percent reduction in reporting from manufacturers would not result in a large reduction in benefits. EPA requests any information that can be provided to refine its estimates related to cost savings of this proposed action.

V. References

The following is a listing of the documents specifically referenced in this document. The docket includes these documents and other information EPA considered, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. EPA. Economic Analysis for the Proposed Rule entitled: "Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping under the Toxics Substances Control Act (TSCA); Revision to Regulation." May 2025.

2. EPA. Final Report of the Small Business Advocacy Review Panel on EPA's Proposed Rule: Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. August 2, 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0549-0123.

3. EPA. Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. November 2022.

4. EPA. Economic Analysis for the Final TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. September 2023.

5. EPA. Final Regulatory Flexibility Analysis and Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. September 2023.

6. EPA. "National PFAS Testing Strategy: Identification of Candidate Per- and Poly-fluoroalkyl Substances (PFAS) for Testing." October 2021. Available at https://www.epa.gov/system/files/documents/2021-10/pfas-natl-test-strategy.pdf.

7. European Chemicals Agency (ECHA). "Per-and polyfluoroalkyl substances (PFAS)." August 2025. Available at https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas.

8. Lexxion. "Global Regulations Around PFAS: The Past, the present and the Future." January 2025. Available at https://icrl.lexxion.eu/article/icrl/2023/1/4/display/html.

9. EPA. "Fact Sheet: Draft Sewage Sludge Risk Assessment for PFOA and PFOS." January 2025. Available at https://www.epa.gov/system/files/documents/2025-01/fact-sheet-draft-sewage-sludge-risk-assessment-pfoa-pfos.pdf.

10. EPA. "Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3)." Available at https://www.epa.gov/system/files/documents/2021-10/genx-chemicals-toxicity-assessment_tech-edited_oct-21-508.pdf.

11. EPA. "Chemical Data Reporting Byproducts, Impurities, and Recycling Scenarios." December 2022. Available at https://tscaguideme.epa.gov/ords/tsca-gme/r/tsca/cdr-guideme/gd?gd=byproductrecycling.

12. EPA. "Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)." May 2025.

VI. Statutory and Executive Orders Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

This action is a significant regulatory action as defined under section 3(f)(1) of Executive Order 12866. Accordingly, it was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866 (58 FR 51735, October 4, 1993). Any changes made in response to Executive Order 12866 review have been documented in the docket. The EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis (Ref. 1) is available in the docket and is briefly summarize in Unit I.E.

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

This action is expected to be an Executive Order 14192 deregulatory action. Details on the estimated cost savings of this proposed rule can be found in EPA's analysis of the potential costs and benefits associated with this action (Ref. 1).

C. Paperwork Reduction Act (PRA)

The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2682.03, to replace an existing approved ICR. You can find a copy of the ICR in the docket for this rule (Ref. 12), and it is briefly summarized here.

The reporting requirements identified in the proposed rule would enable EPA to meet the statutory obligations required by TSCA section 8(a)(7) and collect data related to the identities, manufacture, use, exposure, and disposal of PFAS manufactured in the United States since 2011. These proposed reporting requirements would also help the Agency to collect existing information on the health and environmental effects of PFAS. EPA intends to use information collected under the rule to assist in chemical assessments under TSCA, and to inform any additional work necessary under environmental protection mandates beyond TSCA. Respondents may claim some of the information reported to EPA under the proposed rule as CBI under TSCA section 14. TSCA section 14(c) requires a supporting statement and certification for confidentiality claims asserted after June 22, 2016.

Respondents/affected entities: Non-exempt manufacturers (including importers) of PFAS in any year between January 1, 2011, and December 31, 2022.

Respondent's obligation to respond: Mandatory (15 U.S.C. 2607(a)(7)).

Estimated number of respondents: 255.

Frequency of response: Once.

Total estimated burden: 134,004 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $11.4 million (per year), includes no annualized capital or operation & maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. The EPA will respond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. OMB must receive comments no later than [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER ].

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule relieves regulatory burden on the small entities subject to the rule. This proposed action would alleviate reporting requirements on small entities subject to an existing rule by exempting certain activities from the scope of reporting. As a result of the proposed exemptions, an estimated 127,469 small article importers would no longer be subject to the regulation. Additionally, as a result of the proposed revisions, an estimated 241 small manufacturing firms would see lower reporting costs. Affected small businesses are expected to be relieved of $703-$761 million in costs. This proposed action would not impose incremental costs on any small entities. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million (in 1995 dollars and adjusted annually for inflation) or more as described in UMRA, 2. U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. This action does not impose substantial direct compliance costs on federally recognized Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of "covered regulatory action" in section 2-202 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental human health risk or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply. Although this action would not establish an environmental standard intended to mitigate health or safety risks, the information that would be submitted to EPA in accordance with this proposed rule would be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information may also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, which would allow the Agency and others to take appropriate action to investigate and mitigate those risks.

I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

This action is not a "significant energy action" because it is not likely to have any adverse effect on the supply, distribution or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.

Therefore, for the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 705 as follows:

PART 705-REPORTING AND RECORDKEEPING REQUIREMENTS FOR CERTAIN PER- AND POLYFLUOROALKYL SUBSTANCES

The definitions in this section and the definitions in TSCA section 3 apply to this part. In addition, the definitions in 40 CFR 704.3 also apply to this part.

* * * * *

The requirements of this part apply to all chemical substances and mixtures containing a chemical substance that are a PFAS, consistent with the definition of PFAS at § 705.3, except as described in § 705.12.

* * * * *

A person described in § 705.10 is not subject to the requirements of this part with respect to any chemical substance described in § 705.5, when:

(a) The person imported municipal solid waste streams for the purpose of disposal or destruction of the waste.

(b) The person is a Federal agency which imports PFAS when it is not for any immediate or eventual commercial advantage.

(c) The person manufactured (including imported) the chemical substance solely in small quantities for research and development.

(d) The person imported the chemical substance as part of an article.

(e) The person manufactured the chemical substance in a manner described in 40 CFR 720.30(h).

(f) The person manufactured (including imported) the chemical substance in a mixture or article, below a 0.1% de minimis concentration.

* * * * *

The revisions to read as follows:

For the one-time submission, persons identified in § 705.10 must report to EPA, for each site of each of the chemical substances identified in § 705.5, the following information to the extent known to or reasonably ascertainable by them. In the event that actual data is not known to or reasonably ascertainable by the submitter, then reasonable estimates may be submitted.

* * * * *

(b) Chemical-specific information. The following chemical-specific information must be reported for each chemical substance that is a PFAS manufactured for each year since January 1, 2011. This includes each chemical substance that is a PFAS and incorporated into mixtures:

* * * * *

Table 5 to Paragraph (c)(4)-Codes for Reporting Consumer and Commercial Product Categories

* * * * *

(f) * * *

(1) Organization for Economic Cooperation and Development (OECD) Harmonized Templates. For each unpublished study report, the submitter shall complete an OECD Harmonized Templates for Reporting Chemical Test Summaries and submit the accompanying study reports and supporting information. This can be accomplished by using the freely available IUCLID software. Templates need not be prepared for exposure-related information the manufacturer is otherwise submitting through the reporting application described in § 705.35.

* * * * *

* * * * *

All information reported to EPA in response to the requirements of this part must be submitted during the applicable submission period. For all reporters submitting information pursuant to § 705.15, the submission period shall begin on [DATE 2 MONTHS AFTER EFFECTIVE DATE OF THE FINAL RULE], and last for three months: [DATE 2 MONTHS AFTER EFFECTIVE DATE OF THE FINAL RULE], through [DATE 5 MONTHS AFTER EFFECTIVE DATE OF THE FINAL RULE].

* * * * *

The revisions to read as follows:

(a) * * *

(1) * * *

(2) * * *

(i) * * *

(ii) For processing and use data elements required by §§ 705.15(c)(1) through (7);

(iii) * * *

(iv) [Reserved]

* * * * *

(b) * * *

(1) * * *

(2) * * *

(i) Volume. Production volume information required pursuant to §§ 705.15(d)(1), (5), and (6).

* * * * *

(f) Additional requirements for specific chemical identity. A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 705.15(b)(1)(i) only if the identity of that chemical substance is treated as confidential in the Master Inventory File (or as a confidential LVE) as of the time the report is submitted for that chemical substance, if that substance is currently on the Inventory or is an LVE. Any person who asserts a claim of confidentiality for the specific chemical identity under this paragraph must provide a generic chemical name. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must submit with the report detailed written answers to the questions from paragraph (b) of this section and to the following questions.

* * * * *

(g) Joint submissions. If a primary submitter asks a secondary submitter to provide information directly to EPA in a joint submission under § 705.15(b)(1)(i), only the primary submitter may assert a confidentiality claim for the data elements that it directly submits to EPA. The primary submitter must substantiate those claims that are not exempt under paragraph (b)(2) of this section. The secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims that are not exempt under paragraph (b)(3) of this section.

(h) No claim of confidentiality. Information not claimed as confidential business information in accordance with the requirements of this section may be made public ( e.g., by publication of specific chemical name and CASRN on the public portion of the TSCA Inventory). EPA will provide advance public notice of specific chemical identities to be added to the public portion of the TSCA Inventory.

* * * * *

[FR Doc. 2025-19882 Filed 11-12-25; 8:45 am]

BILLING CODE 6560-50-P