EPA’s Fall 2021 Unified Agenda Includes TSCA Rulemakings

On December 10, 2021, the Biden Administration launched its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. Based on the U.S. Environmental Protection Agency’s (EPA) rule list, the Workplace of Chemical Security and Air pollution Prevention (OCSPP) is engaged on the next rulemakings beneath the Poisonous Substances Management Act (TSCA). Rulemakings on the proposed stage embody:

  • Tiered Information Reporting to Inform Prioritization, Threat Analysis, and Threat Administration Underneath TSCA (2070-AK62): EPA is growing this rule to acquire details about potential hazards and publicity pathways associated to sure chemical compounds, significantly occupational, environmental, and shopper publicity data. EPA states that this data is required to tell prioritization, danger analysis, and danger administration of the chemical substances beneath TSCA Part 6. EPA intends to publish a discover of proposed rulemaking (NPRM) in July 2022 and a closing rule in March 2023. Extra data on the rulemaking is offered in our July 29, 2021, memorandum;

  • Revisions to the TSCA Charges Rule (2070-AK64): In January 2021, EPA proposed updates and changes to the 2018 TSCA Charges Rule. EPA proposed so as to add three new charge classes: a Bona Fide Intent to Manufacture or Import Discover, a Discover of Graduation of Manufacture or Import, and a further charge related to check orders. As well as, EPA proposed exemptions for entities topic to sure charge triggering actions, together with: an exemption for analysis and growth actions; an exemption for entities manufacturing lower than 2,500 kilos of a chemical topic to an EPA-initiated danger analysis charge; an exemption for producers of chemical substances produced as a non-isolated intermediate; and exemptions for producers of a chemical substance topic to an EPA-initiated danger analysis if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based charge allocation for EPA-initiated danger analysis charges in any state of affairs the place a consortium shouldn’t be fashioned and proposed to require export-only producers to pay charges for EPA-initiated danger evaluations. EPA states that in mild of public feedback, it has determined to concern a supplemental proposal and search extra public touch upon adjustments to the January 2021 proposal. EPA intends to concern a supplemental NPRM in February 2022. EPA has not decided when it’ll concern a closing rule. Extra data on the proposed rule is offered in our December 30, 2020, memorandum;

  • New Chemical compounds Procedural Rules to Mirror Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the brand new chemical compounds procedural laws in 40 C.F.R. Half 720 to enhance the effectivity of EPA’s assessment course of and to align its processes and procedures with the brand new statutory necessities. Based on EPA, this rulemaking seeks to extend the standard of data initially submitted in new chemical compounds notices and enhance its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not decided when it’ll concern a closing rule;

  • Procedures for Submitting Info Topic to Enterprise Confidentiality Claims Underneath TSCA (2070-AK68): EPA states that it’s contemplating proposing new and amended guidelines in regards to the assertion and upkeep of claims of enterprise confidentiality (i.e., confidential enterprise data (CBI)) beneath TSCA. The 2016 TSCA amendments included a number of new provisions in regards to the assertion and EPA assessment and therapy of confidentiality claims. EPA is contemplating procedures for submitting and supporting such claims in TSCA submissions, together with substantiation necessities, exemptions, digital reporting enhancements, and upkeep or withdrawal of confidentiality claims. EPA can also be contemplating whether or not the proposed rule ought to elaborate on EPA’s procedures for reviewing and speaking with TSCA submitters about confidentiality claims. Based on EPA, it expects the proposed rule to incorporate new provisions, in addition to revisions to present guidelines on asserting confidentiality claims to adapt to the 2016 amendments. EPA intends to concern an NPRM in April 2022;

  • Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Underneath TSCA Part 6(a) (2070-AK71): TSCA Part 6 requires EPA to deal with unreasonable dangers of harm to well being or the setting that the Administrator has decided are offered by a chemical substance beneath the circumstances of use. Following a TSCA Part 6 danger analysis for HBCD, EPA initiated rulemaking to deal with unreasonable dangers of harm to well being and the setting recognized within the closing danger analysis. EPA intends to publish an NPRM by September 2022 and a closing rule by April 2024. Extra data on the ultimate danger analysis is offered in our September 28, 2020, memorandum;

  • 1-Bromopropane; Rulemaking Underneath TSCA Part 6(a) (2070-AK73): TSCA Part 6 requires EPA to deal with unreasonable dangers of harm to well being or the setting that the Administrator has decided are offered by a chemical substance beneath the circumstances of use. Following a TSCA Part 6 danger analysis for 1-bromopropane, EPA initiated rulemaking to deal with unreasonable dangers of harm to well being recognized within the closing danger analysis. EPA intends to concern an NPRM in October 2022 and a closing rule in Could 2024. Extra data on the ultimate danger analysis is offered in our August 11, 2020, memorandum;

  • Carbon Tetrachloride; Rulemaking Underneath TSCA Part 6(a) (2070-AK82): TSCA Part 6 requires EPA to deal with unreasonable dangers of harm to well being or the setting that the Administrator has decided are offered by a chemical substance beneath the circumstances of use. Following a TSCA Part 6 danger analysis for carbon tetrachloride, EPA initiated rulemaking to deal with unreasonable dangers of harm to well being recognized within the closing danger analysis. EPA intends to concern an NPRM in October 2022 and a closing rule in June 2024. Extra data on the ultimate danger analysis is offered in our November 4, 2020, memorandum;

  • Trichloroethylene (TCE); Rulemaking Underneath TSCA Part 6(a) (2070-AK83): TSCA Part 6 requires EPA to deal with unreasonable dangers of harm to well being or the setting that the Administrator has decided are offered by a chemical substance beneath the circumstances of use. Following a TSCA Part 6 danger analysis for TCE carried out beneath the authority of TSCA Part 6, EPA initiated rulemaking to deal with unreasonable dangers of harm to well being recognized within the closing danger analysis. EPA intends to concern an NPRM in October 2022 and a closing rule in June 2024. Extra data on the ultimate danger analysis is offered in our November 24, 2020, memorandum;

  • Asbestos (Half 1: Chrysotile Asbestos); Rulemaking beneath TSCA Part 6(a) (2070-AK86): TSCA Part 6 requires EPA to deal with unreasonable dangers of harm to well being or the setting that the Administrator has decided are offered by a chemical substance beneath the circumstances of use. Following a TSCA Part 6 danger analysis for chrysotile asbestos, EPA initiated rulemaking to deal with unreasonable dangers of harm to well being recognized within the closing danger analysis. EPA intends to concern an NPRM by April 2022 and a closing rule by November 2023. Extra data on the ultimate danger analysis is offered in our January 4, 2021, memorandum;

  • Reconsideration of Procedures for Chemical Threat Analysis Underneath the Amended TSCA (2070-AK90): EPA revealed a closing rule on July 20, 2017, that established a course of for conducting danger evaluations to find out whether or not a chemical substance presents an unreasonable danger of harm to well being or the setting, with out consideration of prices or different non-risk components, together with an unreasonable danger to a doubtlessly uncovered or vulnerable subpopulation, beneath the circumstances of use. This course of incorporates the science necessities of the amended statute, together with greatest out there science and weight of the scientific proof. The ultimate rule established the steps of a danger analysis course of, together with: scope, hazard evaluation, publicity evaluation, danger characterization, and danger dedication. EPA states that it’s now within the means of reconsidering the ultimate rule in step with new government orders (EO) in regards to the development of racial fairness and assist for underserved communities by the federal authorities (EO 13985), the safety of public well being and the setting and restoring science to sort out the local weather disaster (EO 13990), tackling the local weather disaster at house and overseas (EO 14008), and different Administration priorities (such because the Presidential memorandum on restoring belief in authorities by scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 closing rule based mostly on its reconsideration, it’ll solicit public remark by an NPRM. EPA intends to publish an NPRM in September 2022;

  • Regulation of Persistent, Bioaccumulative, and Poisonous (PBT) Chemical compounds Underneath TSCA Part 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Additional Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the laws relevant to PIP (3:1) promulgated beneath TSCA. Particularly, EPA proposes to increase the compliance date relevant to the processing and distribution in commerce of sure PIP (3:1)-containing articles and the PIP (3:1) used to make these articles till October 31, 2024, together with the related recordkeeping necessities for producers, processors, and distributors of PIP (3:1)-containing articles. EPA notes that the articles coated by the proposed rule embody a variety of key shopper and business items equivalent to mobile telephones, laptop computer computer systems, and different digital and electrical units and industrial and business gear utilized in varied sectors, together with transportation, development, agriculture, forestry, mining, life sciences, and semiconductor manufacturing. The proposed rule follows a recently-issued closing rule that prolonged the compliance date relevant to the processing and distribution in commerce of sure PIP (3:1)-containing articles, and the PIP (3:1) used to make these articles, from March 8, 2021, to March 8, 2022, together with the related recordkeeping necessities. Feedback on the proposed rule are due December 27, 2021. EPA intends to concern a closing rule in March 2022. Extra data on the proposed rule is offered in our October 25, 2021, memorandum; and

  • TSCA Part 8(a) Reporting and Recordkeeping Necessities for Asbestos (2070-AK99): This rulemaking, beneath the authority of TSCA Part 8(a), would require the upkeep of information and submission to EPA of studies by producers, importers, and processors of asbestos and mixtures and articles containing asbestos (together with as an impurity). EPA states that the data sought consists of information on the portions of asbestos utilized in making merchandise, worker publicity information, and waste disposal information. Reported data could be utilized by EPA and different federal businesses in contemplating the regulation of asbestos. EPA intends to concern an NPRM in March 2022 and a closing rule in November 2022.

The Unified Agenda lists the next TSCA rulemaking on the closing stage:

  • Vital New Makes use of of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Necessities for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending parts of the Vital New Makes use of of Chemical Substances laws at 40 C.F.R. Half 721, particularly the “Protection in the Workplace” (40 C.F.R. Part 721.63) and “Hazard Communication Program” (40 C.F.R. Part 721.72). 81 Fed. Reg. 49598. The proposed adjustments are meant to align, the place attainable, EPA’s laws with the revised Occupational Security and Well being Administration (OSHA) laws at 29 C.F.R. Part 1910.1200. OSHA issued a closing rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Requirements with the Globally Harmonized System of Classification and Labeling of Chemical compounds (GHS). EPA states that it’s reviewing the feedback obtained and is planning to concern a closing rule. EPA intends to concern a closing rule in September 2022. Extra data on EPA’s 2016 proposed rule is offered in our July 29, 2016, memorandum.

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