2024-19931. Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Change to Submission Period and Technical Correction

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Environmental Protection Agency

1. 40 CFR Part 705
2. [EPA-HQ-OPPT-2020-0549; FRL-7902.1-02-OCSPP]
3. RIN 2070-AK67

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule; change to submission period and technical correction.

SUMMARY:

The Environmental Protection Agency (EPA or Agency) is taking direct final action to amend the Toxic Substances Control Act (TSCA) regulation with reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS). As promulgated in October 2023, the regulation requires manufacturers (including importers) of PFAS in any year between 2011-2022 to report certain data to EPA related to exposure and environmental and health effects. EPA is making a one-time modification to change the beginning of the data submission period from November 12, 2024, to July 11, 2025, with a corresponding change to the end of the submission period. EPA is also making a technical correction to address an error in the regulatory text. There are no other changes to the reporting and recordkeeping requirements in the existing rule under TSCA.

DATES:

This rule is effective November 4, 2024 without further notice. However, if EPA receives adverse comment by October 7, 2024, the Agency will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0549, online at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information: Stephanie Griffin, Data Gathering, Management, and Policy Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-1463; email address: [e-mail].

For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

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 since January 1, 2011. The following list of North American Industrial 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:

• Construction (NAICS code 23);
• Manufacturing (NAICS codes 31 through 33);
• Wholesale trade (NAICS code 42); ( print page 72337)
• Retail trade (NAICS codes 44 through 45); and
• Waste management and remediation services (NAICS code 562).

This list details the types of entities that EPA is aware could potentially be impacted by this action. Other types of entities not listed could also be impacted. To determine whether your entity is impacted by this action, you should carefully 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 (see above).

Any use of the term “PFAS” will apply to chemical substances that meet the structural definition of PFAS codified at 40 CFR 705. PFAS is defined as including at least one of these three structures:

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

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

CF₃ C(CF₃)R′R″, where R′ and R″ can either be F or saturated carbons.

The requirements of this rule also apply to PFAS manufactured as a byproduct or impurity or in articles or mixtures. Further, this rule is not limited to PFAS currently on the TSCA Chemical Substance Inventory. For a more thorough discussion of the chemical substances included in this rule, please see Unit III.A. of the final rulemaking (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) 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, 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; and, any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954.

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

As with the final rule that published in the Federal Register of October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP)), EPA is promulgating 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). This 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.

TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential business information (CBI).

C. What action is the Agency taking?

EPA is issuing this amendment to change the data submission period for the TSCA section 8(a)(7) PFAS reporting rule that is codified in 40 CFR part 705, by changing the start date to July 11, 2025, and making corresponding changes to the end dates for the submission period. For reasons detailed in Unit II., the Agency is compelled to take this action in response to constraints on the timely development and testing of the software being developed to collect information pursuant to this reporting rule ( i.e., the rule's reporting application). EPA is also taking action to correct an inadvertent error in the rulemaking by revising the text “published study reports” under the requirement to submit Organization for the Economic Cooperation and Development's (OECD) Harmonised Templates (OHTs) to the correct requirement of submitting OHTs for “unpublished study reports.” EPA intended to require OHTs only for unpublished study reports and is correcting the text accordingly.

This action does not alter any other aspect of the TSCA section 8(a)(7) PFAS rule in 40 CFR part 705. This action will result in additional time for the Agency's reporting application to be completed and sufficiently tested to ensure that reporting entities do not experience issues that prevent their submission of data as required under TSCA section 8(a)(7) during the regulatory submission period. Further, without modifying the reporting period, EPA would need to continue to develop the application while reporting is occurring. Forms that were submitted prior to the completion of such continued development could require resubmission due to the effects of such ongoing application development. Similarly, forms that were started but not yet submitted could need to be restarted due to the effects of ongoing application development.

The Agency further anticipates being able to review submitted data, including CBI claims, and prepare non-CBI data for broader dissemination more efficiently if the full data collection infrastructure is established prior to the start of the submission period. Further, this action is consistent with the public interest because it is designed to facilitate compliance with the rule and to ensure that the collection includes accurate data on manufactured PFAS in the United States. Any impact on the regulated community is expected to be beneficial given that the extension provides additional time to submit accurate reports to EPA.

D. Why is the Agency using a direct final rule?

EPA is taking direct final action because the Agency views this as a noncontroversial action and anticipates no adverse comment. Although EPA continues to devote significant resources to development of the reporting application, EPA will not be in a position to accept data in a usable manner under the current start date of November 12, 2024, and thus it will be impossible for submitters to begin to submit data on that date. For reasons detailed in Unit II., the reporting timeline is no longer tenable and maintaining that deadline would require entities to submit data before EPA has the technological capacity in place to accept that data. This would negatively impact EPA's ability to collect, organize, and make the collected data available to the public, which is the underlying objective of the regulation as well as the Congressional direction that required its promulgation.

This action also includes a technical correction to revise an error in the regulatory text. At 40 CFR 705.15(f)(1), the requirement for PFAS manufacturers to submit all existing information concerning the environmental or health effects of that PFAS stipulates that the OHTs must be completed for “each published study report” [emphasis added]. EPA's intent was to require OHTs and supporting information for unpublished study reports, as those are not publicly available in open literature (see 88 FR at 70524). Thus, this action also revises the word “published” to “unpublished” at 40 CFR 705.15(f)(1). ( print page 72338)

In the “Proposed Rules” section of this issue of the Federal Register , EPA is publishing a separate document that will serve as the proposed rule to amend the beginning of the submission period if adverse comments are received on this direct final rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of the document in the “Proposed Rules” section of this Federal Register publication.

If EPA receives adverse comment, the Agency will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. In this case, EPA would address all public comments in a subsequent final rule. EPA reiterates that there is no feasible way to begin collecting the TSCA section 8(a)(7) dataset by November 12, 2024, so maintaining the current submission period timeline is not tenable.

II. Background

A. What is the modification to the submission period?

The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) considerably expanded the scope of EPA's responsibilities under TSCA. The amendments require EPA to systematically and comprehensively prioritize and evaluate at least 20 chemicals at the same time and provide protections against the identified unreasonable risks through regulations. Under the amended law, EPA is also required to complete formal risk determinations for 100 percent of all new chemical submissions, as compared to the pre-2016 practice of completing formal risk determinations on about 20 percent of such submissions. The amended law also provides new responsibility for increasing transparency and new data-gathering authority to support the Agency assessments. EPA's appropriated resources for implementing TSCA have not kept pace with the Agency's activities and obligations under amended TSCA. For example, the enacted budget for fiscal year 2024 resulted in an $8.4 million reduction to contracts and other non-payroll TSCA funding levels when compared with funding for fiscal year 2023 (a ~33% reduction).

As described in this unit, this increased responsibility alongside reduced funding has forced EPA to make difficult choices, including delays in activities that impact the Agency's ability to collect data for the TSCA section 8(a)(7) requirement during the reporting period that had been anticipated when the Agency promulgated the rule.

Nearly all TSCA regulatory submissions are required to be submitted through EPA's Central Data Exchange (CDX). CDX provides EPA's interface with data submitters, including fulfillment of all legal requirements for electronic submittals as set out by the Cross-Media Electronic Reporting Rule (CROMERR) (40 CFR part 3).

When EPA uses CDX to collect information, the Agency must also develop a corresponding application in its TSCA CBI environment, which is used to manage the final validation and processing of submitted content. Each submission to CDX is transmitted into the appropriate TSCA CBI application for further processing, storage, and use. After successfully processing a submission, a secure message is sent back to CDX, which updates the submission status to “submitted” and provides a Case Number to the submitter for their reference. Functional CDX and CBI applications are necessary for a regulated entity to fully and legally submit the required information to EPA and demonstrate compliance with the regulation under which the information was submitted.

Under the NDAA, EPA was directed to write the final rule that was published on October 11, 2023 (88 FR 70516 (FRL-7902-02-OCSPP)). EPA's obligation under the NDAA to use its TSCA section 8 authority is critical to the Agency's understanding of PFAS in commerce. The information required under the TSCA section 8(a)(7) rule will create a comprehensive database of previously manufactured PFAS in commerce and support EPA's actions to address PFAS exposure and contamination.

From a TSCA perspective, the amount of data that is expected to be submitted under this rule is unprecedented due to the number of chemicals and years of data for which this reporting requirement applies, underscoring the critical need to ensure the fidelity of the process and the data, which can only be achieved by delaying the start of the reporting period. To fully ensure the Agency's reporting platform can manage this volume of materials, an industry testing period will be required. This is built into the new timeline with a sufficient window to allow for software updates and modifications based upon this testing.

For technical reasons explained in Unit II. B., EPA must delay the data submission period of this rule. EPA will not be able to accept, confirm receipt, and ensure fidelity of reported PFAS information at the original reporting start date of November 12, 2024. It is in the interest of the general public and industry that EPA move the start of the reporting period from November 12, 2024, to July 11, 2025, to ensure that the infrastructure underlying the data collection process is working optimally, thus ensuring ultimate public access, as appropriate, to this information. It is for these reasons that EPA, as a matter of good governance, must postpone the submission periods codified in the final rule (88 FR 70516, October 11, 2023 (FRL-7902-02-OCSPP)). As codified, this includes a start and end date for submission, including an alternate end date for small entities.

B. Why is the Agency modifying the data submission period?

Due to increased statutory obligations across the TSCA Existing and New Chemicals programs and a lack of increased resources to meet those obligations, including a 5 percent reduction to the TSCA program in Fiscal Year 2024 compared to what was appropriated in Fiscal Year 2023 and an unfunded Cost of Living Adjustment for FY 2024, EPA's Office of Pollution Prevention and Toxics (OPPT) was forced to make difficult choices to ensure that the program was able to continue its work to protect human health and the environment from the risks presented by toxic chemical substances. Because of this challenge, as a result of competing priorities for information technology/information management (IT/IM) resources, and in response to the uncertainties associated with working under three successive Continuing Resolutions that lasted through March 9, 2024, which resulted in EPA receiving funding via 30-day increments and thus, due to the lack of a budget, being unable to project funding availability for the year, OPPT was forced to significantly reduce its IT/IM operating budget in FY2024 to prevent overspending of resources. Software development efforts in process and operations and maintenance activities associated with both CDX and TSCA CBI-based applications, which are critical to the Agency's TSCA data collections, including the data collected under this rule, were impacted by these reductions, resulting in increased costs due to unforeseen complications arising with existing software applications as well as forecasted resource needs for developing new software applications. ( print page 72339) The reduced funding for this work would primarily have been used for the contractual support on which EPA relies for much of its IT/IM efforts.

Because the decrease in resources impacted the funds available for contractor support, EPA's contractors reduced their effort on the TSCA information technology software and related portfolio by more than 50 percent, which had significant, immediate implications for EPA's ability to make progress on many of its IT/IM projects. Most significantly for this rule, software development needed to be re-prioritized so only those projects with the nearest-term deadlines received resources and effort. For example, when the asbestos reporting application had to be developed by spring 2024, contractor staff supporting other applications ( e.g., TSCA section 8(a)(7), Chemical Data Reporting (CDR), and operations and maintenance) were re-allocated to that effort. Additionally, the asbestos reporting application required additional support beyond what was initially anticipated due to CBI-related reporting nuances that took more resources, including time, to implement and delayed the receipt of reporting for that rule. This process of focusing development on reporting requirements with the nearest-term deadlines was shortly thereafter repeated in support of the 2024 CDR reporting cycle, which began on June 1, 2024. EPA was only able to allocate resources for development of the reporting application for this TSCA section 8(a)(7) rule in May 2024. These resources immediately went to reassembling, training, and additional onboarding of the team (staff had been previously transitioned from the TSCA section 8(a)(7) reporting application due to the re-prioritizing activities described above). These activities were completed in June 2024, by which time developing a fully functioning reporting tool by the submission period date in the TSCA section 8(a)(7) final rule was impossible due to the significant amount of development required to ensure that the application would fully support the required data elements, including the ability to make, as applicable, associated CBI claims. (88 FR 70516 October 11, 2023 (FRL-7902-02-OCSPP)). Further, EPA typically conducts testing prior to making an application available, and in response to users having difficulties using some of the other recent TSCA applications ( e.g., the application for asbestos reporting), ensuring that the Agency has adequate time to test the TSCA section 8(a)(7) PFAS reporting application is critical. Relatedly, EPA has committed to providing interested industry stakeholders an opportunity to help test the application to ensure that it could collect the data as intended, which the timeline for the current reporting period does not allow.

To ensure functioning reporting capability, EPA must extend the development project timeline. Accordingly, the reporting tool will be available beginning July 11, 2025. This action will maintain all other reporting obligations under TSCA section 8(a)(7), and reporters will still have the same amount of time to submit data as codified at 40 CFR 705.

C. What is the technical correction?

Additionally, EPA is using this action to amend a typographical error in the regulation's paragraph related to the submission of OHTs. The regulatory text at 40 CFR 705.15(f)(1) currently states that OHTs are required for “published study reports.” Requiring OHTs for published study reports was not the intent of the final rule, nor would this yield any benefits, if submitters are not required to submit information that is in open scientific literature. This phrase should have read “unpublished study reports,” which is consistent with EPA's explanation in the final rule preamble: “EPA is not requiring manufacturers to search open scientific literature to find relevant information on a PFAS that was previously not in their possession or control for the purpose of this rule. EPA believes that implementing such a requirement may result in duplicative information, if multiple PFAS manufacturers are submitting the same studies or other information that are available publicly (including in EPA's scientific literature databases)” (88 FR 70524, October 11, 2023 (7902-02-OCSPP)).

IV. Statutory and Executive Orders Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review

This action is not a significant regulatory action as defined in Executive Order 12866(58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to Executive Order 12866 review.

B. Paperwork Reduction Act (PRA)

This action does not contain any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2070-0217 (EPA ICR No. 2682.02). This action does not create any new reporting or recordkeeping obligations, and does not otherwise change the burden estimates that were approved.

C. 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, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this action is any significant adverse economic impact on small entities and that the agency is certifying that this action will not have a significant economic impact on a substantial number of small entities because the rule has no net burden on the small entities subject to the rule. This direct final rule provides the same timeframe for reporting, while delaying the start date and otherwise adds no new reporting requirements. This action only postpones the start of the information submission period already required and makes a technical correction to the regulatory text. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

D. 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.

E. 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.

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

This action does not have Tribal implications as specified in Executive Order 1317(65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship ( print page 72340) 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.

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply. Although this does not concern an environmental health or safety risk and does not materially alter the reporting requirements under TSCA section 8(a)(7), EPA believes that the one-time data collection imposed in the 2023 final rule will aid in collecting all existing and reasonably ascertainable information related to the manufacturing (including importing) of PFAS since 2011. As noted in the 2023 final rule, this one-time collection will help identify data gaps surrounding the knowledge of commercially manufactured PFAS. Understanding the extent of existing data gaps related to manufactured PFAS will also help inform and tailor future EPA actions to address PFAS as needed. The one-time collection will provide information on the quantity of PFAS to which children may be exposed. EPA believes that the information obtained as a result of this one-time data collection could also be used by the public, government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential human health or environmental risks, including potential risks to children.

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

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have any adverse effect on the supply, distribution or use of energy.

I. 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.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All

The EPA believes that this type of action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to potentially disproportionate and adverse effects on communities with environmental justice concerns in accordance with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 25251, April 26, 2023). This action does not materially alter the reporting requirements under TSCA section 8(a)(7), as discussed in Unit II.

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This does not meet the criteria set forth in 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 705

• Chemicals
• Environmental protection
• Reporting and recordkeeping requirements

Dated: August 29, 2024.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

Therefore, for the reasons set forth in the preamble, 40 CFR part 705 is amended as follows:

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

1. The authority for part 705 continues to read as follows

Authority: 42 U.S.C. 2607(a)(7).

2. Amend § 705.15 by revising paragraph (f)(1) to read as follows:

§ 705.15

What information to report.

* * * * *

(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.

* * * * *

3. Revise § 705.20 to read as follows:

§ 705.20

When to report.

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 and 705.18(b) (research and development), the submission period shall begin on July 11, 2025, and last for six months: July 11, 2025, through January 11, 2026. For any reporter who is reporting under this part exclusively pursuant to § 705.18(a) (article importers), and is also considered a small manufacturer under the definition at 40 CFR 704.3, the submission period shall begin on July 11, 2025, and last for 12 months: July 11, 2025, through July 11, 2026.