EPA’s Spring 2023 Unified Agenda Includes Proposed and Final TSCA and TRI Rules

The U.S. Environmental Protection Agency’s (EPA) spring 2023 Unified Agenda, published on June 13, 2023, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

• Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management under TSCA (RIN: 2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in the Risk Evaluation/Risk Management (RE/RM) Lifecycle and to update the reporting requirements under the 40 C.F.R. Part 711 Chemical Data Reporting (CDR) regulation. EPA states that it is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. According to EPA, this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in February 2024 and a final rule in July 2025. Information on EPA’s July 27, 2021, webinar on a tiered data collection strategy is available in our July 29, 2021, memorandum.
   
• Updates to New Chemicals Regulations under TSCA (RIN: 2070-AK65): EPA is developing proposed amendments to the new chemicals procedural regulations under TSCA that are codified in 40 C.F.R. Parts 720, 721, 723, and 725. EPA states that it is considering amendments to clarify and improve the efficiency of EPA’s new chemicals review process and to align its processes and procedures with the statutory requirements that were amended in 2016 and affected how EPA reviews and makes determinations on new chemical notices under TSCA Section 5. According to EPA, the amended statutory requirements “increased EPA responsibilities and it has become more challenging for EPA to complete reviews within the 90-day statutory review period.” The rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and to improve EPA’s processes for timely, effective completion of the risk assessment and the new chemicals reviews. The rulemaking also seeks to improve EPA’s existing practices related to the review of certain groups of chemical substances under premanufacture notification (PMN) exemptions. Information on EPA’s May 26, 2023, NPRM is available in our May 24, 2023, memorandum. EPA intends to publish a final rule in February 2025.
   
• 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 (RIN: 2070-AK70): EPA published an NPRM on May 3, 2023. EPA intends to issue a final rule in June 2024. More information on EPA’s NPRM, which would prohibit most uses of methylene chloride, is available in our April 25, 2023, memorandum.
     
  • Cyclic Aliphatic Bromide Cluster (HBCD) (RIN: 2070-AK71): EPA intends to publish an NPRM in April 2024. Information on EPA’s final revision to the HBCD risk determination is available in our June 30, 2022, memorandum.
     
  • 1-Bromopropane (1-BP) (RIN: 2070-AK73): EPA intends to publish an NPRM in November 2023 and to issue a final rule in March 2025. Information on EPA’s final revision to the 1-BP risk determination is available in our December 21, 2022, memorandum.
     
  • Carbon Tetrachloride (CTC) (RIN:2070-AK82): EPA published an NPRM on July 28, 2023. EPA intends to issue a final rule in October 2024. More information on the NPRM is available in our July 26, 2023, memorandum.
     
  • Trichloroethylene (TCE) (RIN: 2070-AK83): EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on July 7, 2023. EPA intends to publish an NPRM in October 2023 and a final rule in October 2024. Information on EPA’s final revision to the risk determination for TCE is available in our January 19, 2023, memorandum.
     
  • Perchloroethylene (PCE) (RIN: 2070-AK84): EPA published an NPRM on June 16, 2023. EPA intends to issue a final rule in August 2024. More information on the NPRM is available in our June 16, 2023, memorandum.
     
  • N-Methylpyrrolidone (NMP) (RIN: 2070-AK85): EPA intends to publish an NPRM in October 2023 and to issue a final rule in December 2024. Information on EPA’s final revision to the NMP risk determination is available in our December 21, 2022, memorandum.
     
  • Colour Index Pigment Violet 29 (PV29) (RIN: 2070-AK87): EPA intends to publish an NPRM in May 2024. Information on EPA’s final revision to the PV29 risk determination is available in our September 9, 2022, memorandum.
     
• Procedures for Chemical Risk Evaluation under TSCA (RIN: 2070-AK90): As required under TSCA Section 6(b)(4), EPA published a final rule on July 20, 2017, 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 states that this process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now considering revisions to that final rule and will solicit public comment through a notice of proposed rulemaking. EPA submitted a proposed rule to OMB for review on June 29, 2023. EPA intends to publish an NPRM in September 2023 and to issue a final rule in November 2024. More information on EPA’s 2017 final rule is available in our June 26, 2017, memorandum.
   
• Revisions to Regulations on Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Subject to TSCA (RIN: 2070-AL02): TSCA directs EPA to take expedited action on certain PBTs to address the risks of injury to health or the environment presented by the chemical substance and to reduce exposure to the substance to the extent practicable. Consistent with that mandate, EPA issued final risk management rules restricting the use of five PBT chemicals in January 2021, and the rules went into effect in February 2021. EPA states that it is considering revisions to all five of the final rules to reduce further exposures, promote environmental justice, and better protect human health and the environment. EPA submitted a proposed rule to OMB for review on July 21, 2023. EPA intends to publish an NPRM in October 2023. More information on EPA’s PBT rules is available in our September 3, 2021, memorandum.
   
• 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 Risk Evaluation under TSCA (RIN: 2070-AL05): Although EPA intended to publish an NPRM in June 2023, it has not published anything to date. EPA intends to issue a final rule in May 2024.
     
  • Phthalates (RIN: 2070-AL06): Although EPA intended to publish an NPRM in June 2023, it has not published anything to date. EPA intends to issue a final rule in June 2024.
     
  • Flame Retardants (RIN: 2070-AL07): EPA published an NPRM in June 2023 and intends to issue a final rule in May 2024. More information on the NPRM is available in our July 3, 2023, memorandum.
     
  • Certain Solvents (RIN: 2070-AL08): Although EPA intended to publish an NPRM in June 2023, it has not published anything to date. EPA intends to issue a final rule in May 2024.
     
• Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the TRI (RIN: 2070-AL03): EPA is developing a rulemaking to add certain PFAS to the list of chemicals reportable under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). EPA notes that 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), which directs EPA 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 publish an NPRM in December 2023 and to issue a final rule in November 2024.

Final Rule Stage

• Fees for the Administration of TSCA (RIN: 2070-AK64): EPA states that it is considering comments on its 2022 supplemental proposal to its 2021 proposed updates and adjustments to the 2018 fees rule established under TSCA to inform the development of a final rule. TSCA requires EPA to review and, if necessary, adjust the fees every three years, after consultation with parties potentially subject to fees. With over five years of experience administering the TSCA amendments of 2016, EPA is taking this action to ensure that the fees charged accurately reflect the level of effort and resources needed to implement TSCA in the manner envisioned by Congress when it reformed the law. According to EPA, the supplemental proposal narrowed certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposed exemptions for the test rule fee activities; proposed modifications to the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; proposed a partial refund of fees for PMNs withdrawn at any time after the first ten business days during the assessment period of the chemical; proposed modifications to 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; proposed expanding the fee requirements to companies required to submit information for test orders; proposed modifying the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements (ECA); proposed extending the timeframe for test order and test rule payments; and proposed changes to the fee amounts and the estimate of EPA’s total costs for administering TSCA. EPA intends to issue a final rule in November 2023. More information on EPA’s 2022 supplemental proposed rule is available in our November 18, 2023, memorandum. 
   
• TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for PFAS (RIN: 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 addition to fulfilling statutory obligations under TSCA, EPA states that it expects that the final rule will enable it to characterize better the sources and quantities of manufactured PFAS in the United States. EPA notes that it 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 submitted the final rule to OMB for review on May 25, 2023. EPA intends to issue the final rule in September 2023. More information on the IRFA is available in our November 29, 2022, memorandum, and on the proposed rule in our June 11, 2021, memorandum.
   
• Confidential Business Information (CBI) Claims under TSCA (RIN: 2070-AK68): EPA states that it is considering issuing final new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., CBI under TSCA). 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 CBI claims. EPA is also considering issuing final procedures for reviewing and communicating with TSCA submitters about CBI claims. EPA expects the final rule may include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments to TSCA. EPA issued a final rule on June 7, 2023, which was effective August 7, 2023. More information on the final rule is available in our June 12, 2023, memorandum. As reporting in our forthcoming blog item, on August 10, 2023, EPA announced that it is waiving some of the final rule’s requirements until October 16, 2023.
   
• Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use under TSCA (RIN: 2070-AK86): On April 12, 2022, EPA proposed a rule to address the unreasonable risk of injury to health that EPA identified 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. As reported in our March 20, 2023, memorandum, on March 17, 2023, EPA announced the availability of and solicitation of public comment on additional data received by EPA related to the proposed rule. These additional data pertain to (1) chrysotile asbestos diaphragms used in the chlor-alkali industry and (2) chrysotile asbestos-containing sheet gaskets used in chemical production; these data may be used by EPA in the development of the final rule, including EPA’s determination of what constitutes “as soon as practicable” with regard to the proposed chrysotile asbestos prohibition compliance dates for these uses. EPA intends to issue a final rule in January 2024. More information on EPA’s proposed risk management rule is available in our April 7, 2022, memorandum.
   
• Asbestos; Reporting and Recordkeeping Requirements under TSCA (RIN: 2070-AK99): 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. Reported information would be used by EPA and other federal agencies 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 issued the final rule on July 25, 2023. More information is available in our July 12, 2023, memorandum.
   
• PFAS Designated as Inactive on the TSCA Inventory; SNUR (RIN: 2070-AL10): EPA states that it is considering public comment on a proposed SNUR for those PFAS that have not been manufactured (including imported) or processed for many years and are consequently designated as inactive on the TSCA Chemical Substance Inventory. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. Such a review will assess whether the use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the PFAS subject to this SNUR. EPA intends to issue a final rule in December 2023. More information on the proposed SNUR is available in our January 27, 2023, memorandum.
   
• Addition of Diisononyl Phthalate (DINP) Category; Community Right-to-Know Toxic Chemical Release Reporting (RIN: 2025-AA17): On September 5, 2000, in response to a petition filed under EPCRA, EPA issued a proposed rule to add the DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the Pollution Prevention Act (PPA). EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that this category met the EPCRA toxicity criterion. EPA updated its hazard assessment for DINP and proposed to add DINP as a category defined to include branched alkyl di-esters of 1,2-benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. In 2022, EPA issued a supplemental proposal to add the DINP category to the toxic chemical list based on hazard concerns described in the updated hazard assessment 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. EPA intends to issue a final rule in August 2023. 
   
• Changes to Reporting Requirements for PFAS and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting (RIN: 2070-AK97): EPA is considering comments to its proposal to add PFAS subject to reporting under EPCRA and the PPA pursuant to the NDAA to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). The addition of these PFAS to the list of chemicals of special concern will cause such PFAS to be subject to the same reporting requirements as other chemicals of special concern (i.e., it would eliminate the use of the de minimis exemption and the option to use Form A and would limit the use of range reporting for PFAS). According to EPA, “[r]emoving the availability of these burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for these PFAS.” In addition, EPA proposed to remove the availability of the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. This change will help ensure that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase. EPA submitted a proposed rule to OMB for review on August 7, 2023. EPA intends to issue a final rule in November 2023. More information on the proposed rule is available in our December 7, 2022, memorandum. 
   
• Implementing Statutory Addition of Certain PFAS to the TRI Beginning with Reporting Year 2023 (RIN: 2070-AL14): On December 20, 2019, the NDAA was signed into law. Among other provisions, Section 7321 provides a framework for PFAS to be added automatically to the TRI list on January 1 of the year following certain EPA actions. This final rule will amend the EPCRA regulations to reflect the statutory addition of the PFAS that were automatically added to the TRI list pursuant to the NDAA and are subject to TRI reporting for Reporting Year 2023. EPA published a final rule on June 23, 2023. More information is available in our June 26, 2023, blog item.