On September 5, 2024, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a direct final rule with a parallel proposed rule to delay the reporting period for the October 2023 final rule that requires reporting under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). 88 Fed. Reg. 70516. Wiley provided a summary of this rule in its October 6, 2023 client alert.The reporting period was scheduled to begin on November 12, 2024, but is now proposed to begin on July 11, 2025, and run through January 11, 2026, for most companies. Small businesses reporting data solely on importing PFAS contained in articles will have until July 11, 2026, to submit reports.As a reason for delaying the reporting period, EPA refers to resource constraints in implementing the TSCA program. Specifically, EPA did not have the required resources to update and make available its Central Data Exchange (CDX) software application and TSCA confidential business information-based applications in time for the November 2024 deadline.In addition to delaying the start date for PFAS reporting, EPA is proposing a minor technical correction to the rule text to clarify that it requires Organization for the Economic Cooperation and Development (OECD) Harmonised Templates (OHTs) only for unpublished study report

tly Asked Question No. 57).In Table 4-1 of the Reporting Instructions, the EPA provides illustrations of when it will consider information to be known or reasonably ascertainable, as well as when it might be willing to accept an NKRA claim. For example, if a company has data on its products for three seasons in a year but not the fourth, the EPA would likely accept a report on the basis of the three seasons of known data, but it would not accept a claim of NKRA when partial responsive information exists and is known to a company. Similarly, if the company could not get information from its major supplier but could obtain information from 10 of its minor suppliers and was willing to survey those entities, the EPA would accept this data. It would not accept a claim of NKRA if the company failed to obtain the information from its minor suppliers.How Long Must I Keep Records?The records should be retained for five years, beginning on the last day of the information submission period. (See 88 Fed. Reg. 70516, 70530 (Oct. 11, 2023); 40 C.F.R. § 705.25.)What Will the EPA Do with the Reports?Public Availability: The EPA's stated purpose behind much of chemical regulation – in addition to fulfilling statutory obligations – is to increase public accessibility to nonconfidential chemical data wherever possible. To that end, under TSCA, the EPA seeks to characterize the sources and quantities of manufactured PFAS in the U.S. to further its goals of enhancing understanding of chemical hazards and exposures to better assess risks to human health and the environment, supporting risk reduction efforts and informing efforts to encourage industry to switch to safer chemicals. The EPA's ChemView program provides public access to some data submitted to the agency under TSCA. Although Section 8(a)(7) reporting is not currently listed in ChemView, it is possible that the EPA may add nonconfidential information reported under Section 8(a)(7) to ChemView or otherwise share the underlying data in the future.Confidentiality: To pre

107(a), 42 U.S.C. § 9607(a).4 See Comment from California Farm Bureau on Designation of Perfluorooctanoic (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances (Nov. 7, 2022); See also Comment from The City of Elyria, Ohio Wastewater Pollution Control Plant and Municipal Separate Storm Sewer System (MS4) Regarding the Proposed Regulations Published in the Federal Register: Comprehensive Environmental Response Compensation & Liability Act hazardous Substances: Designation of Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid (Nov. 9, 2022).5 Memorandum from D. Uhlmann, Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance, on PFAS Enforcement Discretion and Settlement Policy under CERCLA (Apr. 19, 2024).6 Id. at 2-3.7 Id. at 3.8 Id.9 Id. at 9.10 CERCLA section 113(f)(2), 42 U.S.C. § 9613(f)(2).11 SeeToxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, Final rule, 88 Fed. Reg. 70516 (Oct. 11, 2023) (to be codified 40 C.F.R. pt. 705); Significant New Use Rules on Certain Chemical Substances (23-2.5e), Proposed rule, 88 Fed. Reg. 39804 (Jun. 20, 2023) (to be codified 40 C.F.R. pt. 721); Per- and Polyfluoroalkyl Substances (PFAS) in Consumer Products, Notice of availability and request for information, 88 Fed. Reg. 64890 (Sep. 20, 2023); Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting, Final rule, 88 Fed. Reg. 74360 (Oct. 31, 2023) (to be codified 40 C.F.R. pt. 372); Revisions to the Air Emissions Reporting Requirements, Proposed rule, 88 Fed. Reg. 54118 (Aug. 9, 2023) (to be codified 40 C.F.R. pts. 2, 51); Clean Water Act Effluent Limitations Guidelines and Standards for the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category, Advance notice of proposed rulemaking, 86 Fed. Reg. 14560 (Mar. 17, 2021) (to be codified 4

formation on environmental or health effects. Covered manufacturers and importers must submit reports to the EPA by May 8, 2025. Small manufacturers who exclusively import articles must report by November 10, 2025.Looking Ahead: Manufacturers and importers should assess whether they have reporting obligations under the rule as soon as possible. Due to the expansive nature of the reporting requirements, the rule may impact manufacturers and importers that have not traditionally been subject to the TSCA. Although final reports are not due until 2025, entities should start preparing and collecting the necessary information without delay to ensure there is sufficient time to compile and report.Introduction On October 11, 2023, EPA published a final rule requiring all manufacturers (including importers) of PFAS to submit one-time reports about such chemicals to the EPA. (Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, 88 Fed. Reg. 70516 (Oct. 11, 2023) (40 C.F.R. Part 705)). The rule is retroactive and applies to PFAS that were manufactured or imported from January 1, 2011, to December 31, 2022. The information collection end-date has not been broadly published, but it appears in the EPA instructional guide.PFAS reports must be submitted to the EPA by May 8, 2025 (18 months after the effective date). (The final rule became effective on November 13, 2023.) Small manufacturers who exclusively import articles have an additional six months to comply, meaning reports must be submitted by November 10, 2025.The rule does not create general exceptions from the reporting requirements for de minimis production levels or for small businesses. The rule is expected to result in a total one-time cost to the private sector of approximately $876 million and 11.6 million work hours in compliance.The Background In 2019, Congress amended the Toxic Substances Control Act ("TSCA") to require the EPA to publish a rule by January 1, 2023, requiring each p

to report this data to EPA within 12 –- 18 months of the PFAS Reporting Rule’s effective date (i.e., November 12, 2024 – May 8, 2025). “Small manufacturers” (as defined at 40 CFR 704.3) will have an additional six months to report (i.e., November 12, 2024 – November 10, 2025).How to reportReports must be completed and submitted using EPA’s Central Data Exchange (CDX).TakeawaysBusinesses that engage with PFAS are on the clock to internally review their past and present importation, production, or manufacture of PFAS and to assess the applicability of the PFAS Reporting Rule to their operations. Although the PFAS Reporting Rule provides covered entities time to submit reports (i.e., 12 – 24 months, depending on the nature of the entity), identification of relevant data and the preparation of reports likely will require time, labor, and cost-intensive internal review processes that businesses should be considering sooner rather than later.FootnotesThe PFAS Reporting Rule can be found at 88 Fed. Reg. 70516 (Oct. 11, 2023), and will be codified at 40 CFR Part 705.See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5954436/.Id.15 USC § 2601 et seq. (1976).

ential and proprietary information submitted under the rule. If CBI claims are not asserted, information submitted under the rule may be publicly available from EPA.Are there recordkeeping requirements?EPA is requiring manufacturers to keep all records of submissions under the rule for a five-year period, which begins on the last date of the submission period. This is consistent with the CDR rule.[22]If I am a manufacturer subject to this rule, what should I do next? If you think your company could be required to report under TSCA Section 8(a)(7), it is important to determine whether you are a manufacturer or an importer of PFAS or of a PFAS-containing article. If you are required to report, begin evaluating the type of information your company may need to gather, dating back to January 1, 2011. Given EPA’s requirement that companies report all information known or reasonably ascertainable, it may be helpful to seek the advice of legal counsel in developing a reporting strategy.[1]See 88 Fed. Reg. 70516.[2]See 88 Fed. Reg. 74360.[3]See 40 CFR §705.1.[4]See 40 CFR §705.3. (definition of article).[5]See 40 CFR §705.3 (definition of manufacture for commercial purpose). Under the definition of “manufacture for commercial purpose,” EPA indicates that the manufacture of “substances that are produced coincidentally during the manufacture, processing, use or disposal of another substance or mixture containing a chemical substance, including both byproducts that are separated from that other substance or mixture containing a chemical substance and impurities that remain in that substance or mixture containing a chemical substance.” The byproducts or impurities may or may not have commercial value, but because they are produced for the purpose of obtaining a commercial advantage, they are part of the manufacture for a commercial purpose.[6]See 40 CFR §705.10 (requiring reporting “through the end of the last calendar year prior to November 13, 2023…”).[7]See 40 CFR §705.3 (definition of Per- an

ant levels under the Safe Drinking Water Act and interim health advisories for certain PFAS. Many of the cases also refer to EPA’s proposal to designate PFOA and PFOS as hazardous substances under CERCLA.As the governments and plaintiffs remain focused on PFAS, businesses and other stakeholders that manufactured or used PFAS should expect to face increasing risk of costs and potential litigation from private and public actors. Regulatory initiatives and general litigation trends often converge. Just as New York has proposed drinking water regulations for additional PFAS (i.e., PFDA, PFHpA, PFHxS, and PFNA), private litigants seek to obtain medical monitoring and scientific testing for individuals exposed to many of the same PFAS.24 Likewise, as states seek to ban PFAS in disposable food containers, the plaintiffs’ bar continues to file consumer actions about the marketing of disposable food containers and packaging.25 Such trends will likely continue and grow in prominence.Footnotes88 Fed. Reg. 70516 (Oct. 11, 2023).https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=2050-AH09.EPA, News Release: EPA Takes Important Step to Advance PFAS Strategic Roadmap, Requests Public Input and Data to Inform Potential Future Regulations under CERCLA (Apr. 13, 2023), https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=2050-AH09.40 C.F.R. § 261.11.EPA, Summary of the Resource Conservation and Recovery Act, https://www.epa.gov/laws-regulations/summary-resource-conservation-and-recovery-act (last updated Sept. 6, 2023); EPA, RCRA Corrective Action Enforcement Authorities, https://www.epa.gov/enforcement/rcra-corrective-action-enforcement-authorities (last updated Apr. 14, 2023).May 30, 2023 Ltr. from State Attorneys General to EPA Administrator Michael Regan, https://www.marylandattorneygeneral.gov/news%20documents/053123_PFAS_Comment_Letter.pdfhttps://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=2040-AG18.Maine DEP, PFAS in Products, https://www.maine.go

PA Launches New Substantiation Functionality In TSCA Applications In CDX: EPA announced on October 6, 2023, that it is deploying application updates, supporting new requirements under the TSCA Confidential Business Information (CBI) Procedural Rule, within its electronic reporting site, Central Data Exchange (CDX). EPA states that the deployments will update the applications requiring CBI substantiations to be provided within the application instead of requiring substantiation documents/templates to be attached. The deployments will also require new communications for reporting TSCA Sections 12, 13, and 8(c) submissions. The deployments began at 5:00 p.m. (EDT) Friday, October 13, 2023. Access to the applications and submissions resumed at 12:00 a.m. (EDT) Monday, October 16, 2023.EPA Issues Final TSCA Section 8(a)(7) Reporting Rule For PFAS:On October 11, 2023, EPA issued a long-overdue final rule under TSCA Section 8(a)(7) regarding reporting and recordkeeping requirements for PFAS. 88 Fed. Reg. 70516. Data are due to EPA within 18 months of the effective date of the final rule, with an additional six months for reports from small businesses that are solely reporting data on importing PFAS contained in articles. The final rule will be effective November 13, 2023. The final rule is not what many of us expected, nor wanted. EPA appears to be indifferent to the due diligence burden, focusing almost entirely on the reporting burden. It remains to be seen if any regulated entities will challenge this final rule. For more information on the final rule, please read the full memorandum.RCRA/CERCLA/CWA/CAA/PHMSA/SDWAEPA Publishes CWA Section 401 Water Quality Certification Improvement Rule: On September 27, 2023, EPA published a final rule revising and replacing the 2020 regulatory requirements for water quality certification under Clean Water Act (CWA) Section 401. 88 Fed. Reg. 66558. EPA states that the final rule updates the existing regulations to align better with the statutory text an