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EPA’s Fall 2022 Unified Agenda Includes Proposed and Final TSCA and TRI Rules
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) fall 2022 Unified Agenda, published on January 4, 2023, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

  • Fees for the Administration of TSCA (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA fees rule (2021 Proposal). In light of public comments, EPA issued a supplemental notice of proposed rulemaking (SNPRM) on November 16, 2022. The SNPRM adds to and modifies the 2021 Proposal. EPA proposes to narrow certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposes exemptions for test rule fee activities; to modify the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; to institute a partial refund of fees for premanufacture notices (PMN) withdrawn at any time after the first ten business days during the assessment period of the chemical; to modify EPA’s proposed methodology for the production volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed; to expand the fee requirements to companies required to submit information for test orders; to modify the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements (ECA); to extend the timeframe for test order and test rule payments; and to change the fee amounts and the estimate of EPA’s total costs for administering TSCA Sections 4, 5, 6, and 14. More information on the SNPRM is available in our November 18, 2022, memorandum. EPA intends to issue a final rule in September 2023.
     
  • Updates to New Chemicals Regulations under TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Parts 720, 721, 723, and 725 to clarify and improve the efficiency of EPA’s review process and align its processes and procedures with the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). This rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve EPA’s processes for timely, effective completion of the risk assessment and of the new chemicals review. The rulemaking also seeks to improve EPA’s existing practices related to the review of certain groups of chemical substances under PMN exemptions. EPA intends to issue a notice of proposed rulemaking (NPRM) in July 2023 and a final rule in November 2024.
     
  • Chemical-Specific Rulemakings under TSCA Section 6(a): TSCA Section 6(a) requires EPA to eliminate unreasonable risks of injury to health or the environment that the Administrator has determined in a TSCA Section 6(b) risk evaluation are presented by a chemical substance under the conditions of use. After risk evaluations for the following chemicals carried out under the authority of TSCA Section 6, EPA will initiate rulemakings to address unreasonable risks of injury to health identified in the final risk evaluations:
     
    • Methylene Chloride (2070-AK70): EPA intends to issue an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for methylene chloride is available in our November 11, 2022, memorandum.
       
    • 1-Bromopropane (1-BP) (2070-AK73): EPA intends to issue an NPRM in September 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for 1-BP is available in our December 21, 2022, memorandum.
       
    • Carbon Tetrachloride (2070-AK82): EPA intends to issue an NPRM in May 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for carbon tetrachloride is available in our December 28, 2022, memorandum.
       
    • Trichloroethylene (TCE) (2070-AK83): EPA intends to issue an NPRM in June 2023 and a final rule in September 2024. More information on EPA’s final revision to its risk determination for TCE will be available in our forthcoming memorandum.
       
    • Perchloroethylene (PCE) (2070-AK84): EPA intends to issue an NPRM in April 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for PCE is available in our December 21, 2022, memorandum.
       
    • N-Methylpyrrolidone (NMP) (2070-AK85): EPA intends to publish an NPRM in September 2023 and a final rule in August 2024. More information on EPA’s final revision to its risk determination for NMP is available in our December 21, 2022, memorandum.
       
  • Procedures for Chemical Risk Evaluation under TSCA (2070-AK90): EPA states that it is considering revisions to its 2017 final rule that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. EPA intends to publish an NPRM in May 2023. More information on the 2017 final rule is available in our June 26, 2017, memorandum.
     
  • Revisions to Regulations on Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Subject to TSCA Section 6(h) (2070-AL02): EPA is considering revisions to the five PBT rules issued in January 2021 to reduce further exposures, promote environmental justice, and better protect human health and the environment. More information on the PBT rules is available in our December 23, 2020, memorandum. More information on EPA’s extension of the compliance dates for articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) is available in our March 7, 2022, memorandum. EPA intends to issue an NPRM in November 2023 and a final rule in September 2024.
     
  • Significant New Use Rules (SNUR) for Certain Non-Ongoing Uses: EPA states that it is authorized to designate a particular new use (or return of a phased-out use) of a chemical substance as a “significant new use” under TSCA Section 5(a)(2) by rule after consideration of relevant factors. EPA would use these rules to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. Persons subject to the SNUR who intend to manufacture (including import) or process the chemical substance for the significant new use must notify EPA at least 90 days prior to initiating activities via a significant new use notice (SNUN). EPA is developing TSCA Section 5(a)(2) SNURs on conditions of use identified as not currently ongoing in the final scope documents for the following High Priority Substances undergoing TSCA Section 6 risk evaluations:
     
    • Other Chemical Substances Undergoing TSCA Section 6 Risk Evaluation (2070-AL05): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Phthalates (2070-AL06): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Flame Retardants (2070-AL07): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
    • Certain Solvents (2070-AL08): EPA intends to issue an NPRM in April 2023 and a final rule in March 2024.
       
  • Per- and Polyfluoro Alkyl Substances (PFAS) Designated as Inactive on the TSCA Inventory; SNUR (2070-AL10): EPA is developing a SNUR under TSCA Section 5(a)(2) for certain uses of PFAS that are designated as Inactive on the TSCA Inventory. Although EPA intended to issue an NPRM in December 2022, it has not published anything to date. EPA plans to issue a final rule in December 2023.
     
  • Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting (2070-AK97): EPA is developing a proposal to add certain PFAS subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) to the list of Lower Thresholds for Chemicals of Special Concern (Chemicals of Special Concern). EPA states that the addition of the PFAS to the Chemicals of Special Concern list will eliminate the use of the de minimis exemption, eliminate the option to use Form A, and limit the use of range reporting. In addition, EPA proposes to eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list. More information on EPA’s December 5, 2022, NPRM is available in our December 7, 2022, memorandum. EPA intends to issue a final rule in November 2023.
     
  • Addition of Certain PFAS to the TRI (2070-AL03): EPA is developing a rulemaking to add certain PFAS to the list of chemicals reportable under EPCRA Section 313. The proposed addition of these PFAS is in direct response to a statutory mandate under Section 7321(d) of the National Defense Authorization Act for Fiscal Year 2020 (NDAA). Under Section 7321(d), EPA is required to evaluate whether certain PFAS meet the EPCRA Section 313 listing criteria by December 2021 and is required to add any PFAS that EPA determines meet the listing criteria by December 2023. EPA intends to issue an NPRM in May 2023 and a final rule in February 2024.

Final Rule Stage

  • TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for PFAS (2070-AK67): EPA published a proposed rule on June 28, 2021, addressing reporting and recordkeeping requirements for PFAS under TSCA Section 8(a)(7). In accordance with obligations under TSCA Section 8(a), as amended by NDAA Section 7351, persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. In November 2022, EPA solicited additional public comments on an Initial Regulatory Flexibility Analysis (IRFA) following the completion of a Small Business Advocacy Review (SBAR) Panel addressing the proposed PFAS reporting and recordkeeping requirements. EPA intends to issue a final rule in March 2023. More information on the 2021 proposed rule is available in our June 11, 2021, memorandum. More information on the IRFA is available in our November 29, 2022, memorandum.
     
  • Confidential Business Information (CBI) Claims under TSCA (2070-AK68): EPA is considering issuing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., CBI) under TSCA. The Lautenberg Act amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering issuing final procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering issuing final procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA intends to issue a final rule in February 2023. More information on EPA’s May 2022 NPRM is available in our May 17, 2022, and May 18, 2022, memoranda.
     
  • Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use under TSCA Section 6(a) (2070-AK86): On April 12, 2022, EPA proposed a rule under TSCA to address the unreasonable risk of injury to health for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, part 1: Chrysotile Asbestos. EPA proposed to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also proposed to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use and other chrysotile asbestos-containing gaskets for consumer use. Finally, EPA also proposed disposal and recordkeeping requirements for these conditions of use. EPA is reviewing the comments received and intends to develop a final rule. EPA intends to issue a final rule in October 2023. More information on EPA’s proposed rule is available in our April 7, 2022, memorandum.
     
  • Asbestos; Reporting and Recordkeeping Requirements under TSCA (2070-AK99): EPA states that this rulemaking, under the authority of TSCA Section 8(a), would require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) to report certain exposure-related information, including quantities of asbestos and asbestos-containing articles manufactured (including imported) or processed, types of asbestos use, and employee data. EPA and other federal agencies would use the reported information in considering the regulation of asbestos. EPA notes that this rulemaking is the result of a settlement agreement, stemming from litigation pursuant to TSCA Section 21. See Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. EPA intends to issue a final rule in May 2023. More information on EPA’s May 2022 NPRM is available in our May 6, 2022, memorandum.
     
  • Addition of Diisononyl Phthalate (DINP) Category; Community Right-to-Know Toxic Chemical Release Reporting (2025-AA17): On September 5, 2000, in response to a petition filed under EPCRA, EPA issued a proposed rule to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the PPA. EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that the category met the EPCRA toxicity criterion. According to EPA, the updated hazard assessment demonstrates that the proposed DINP category meets the EPCRA toxicity criterion because the members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans, specifically, developmental effects, kidney toxicity, and liver toxicity. On August 15, 2022, EPA proposed to add the DINP category to the toxic chemical list and requested comment on the updated DINP hazard assessment and associated updated economic analysis. EPA is considering the public comments received and next steps for this rulemaking. More information on the proposed rule is available in our August 10, 2022, blog item. EPA intends to issue a final rule in May 2023.
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