# Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-29517 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** December 18, 2024 - **Citation:** 89 FR 103512 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 751 [EPA-HQ-OPPT-2020-0592; FRL-8206-02-OCSPP] RIN 2070-AK82 Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA) AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The Environmental Protection Agency (EPA or “Agency”) is finalizing a rule to address the unreasonable risk of injury to health presented by carbon tetrachloride (CTC) under its conditions of use. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk. EPA's final rule will establish workplace safety requirements for most conditions of use, including the condition of use related to the making of low Global Warming Potential (GWP) hydrofluoroolefins (HFOs); prohibit the manufacture (including import), processing, distribution in commerce, and industrial/commercial use of CTC for conditions of use where information indicates use of CTC has ceased; and establish recordkeeping and downstream notification requirements. The use of CTC in low GWP HFOs is particularly important in the Agency's efforts to support the American Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, which was ratified on October 26, 2022. DATES: This final rule is effective on January 17, 2025. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0592, is available online at https://www.regulations.gov . Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information: Emilia Echeveste Briseño, Existing Chemicals Risk Management Division (7404M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number (202) 566-0543; email address: CarbonTetrachlorideTSCA@epa.gov . For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov . SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? 1. General Applicability This action applies to you if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of CTC (CASRN 56-23-5). TSCA section 3(9) defines the term “manufacture” to mean “to import into customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States), produce, or manufacture”. Therefore, unless expressly stated otherwise, importers of CTC are subject to any provisions regulating manufacture of CTC. 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 include: • Chemical Manufacturing (NAICS code 325); • Nonmetallic Mineral Product Manufacturing (NAICS code 327); • Primary Metal Manufacturing (NAICS code 331); • Waste Management and Remediation Services (NAICS code 562); • Petrochemical Manufacturing (NAICS code 325110); • Industrial Gas Manufacturing (NAICS code 325120); • Other Basic Inorganic Chemical Manufacturing (NAICS code 325180); • Cyclic Crude, Intermediate, and Gum and Wood Chemical Manufacturing (NAICS code 325194); • All Other Basic Organic Chemical Manufacturing (NAICS code 325199); • Plastics Material and Resin Manufacturing (NAICS code 325211); • Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320); • All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998); • Cement Manufacturing (NAICS code 327310); • Ground or Treated Mineral and Earth Manufacturing (NAICS code 327992); • Nonferrous Metal (except Aluminum) Smelting and Refining (NAICS code 331410); • NAICS code 562211—Hazardous Waste Treatment and Disposal NAICS code 562211); and • Solid Waste Combustors and Incinerators (NAICS code 562213). 2. Applicability to Importers and Exporters This action may also affect certain entities subject to import certification, and export notification rules under TSCA ( https://www.epa.gov/tsca-import-export-requirements ). Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What is the Agency's authority for taking this action? Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S. Environmental Protection Agency, hereinafter referred to as EPA or “the Agency”, determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. C. What action is the Agency taking? Pursuant to TSCA section 6(b), EPA determined that CTC presents an unreasonable risk of injury to health, without consideration of costs or other nonrisk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS) identified as relevant to the 2020 Risk Evaluation for Carbon Tetrachloride by EPA, under the conditions of use (Refs. 1, 2, 3). A description of the conditions of use that contribute to EPA's determination that CTC presents an unreasonable risk is in the proposed rule (88 FR 49190) (FRL-8206-01-OCSPP) and Unit IV. Accordingly, to address the unreasonable risk, EPA is issuing this final rule under TSCA section 6(a) to: (1) Require a Workplace Chemical Protection Program (WCPP), including an inhalation exposure concentration limit, direct dermal contact controls, and related workplace exposure controls, for the following occupational conditions of use of CTC not prohibited, outlined in Unit IV.B.: • Domestic manufacture; • Import; • Processing as a reactant in the production of hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), HFOs, and perchloroethylene (PCE); • Incorporation into formulation, mixture or reaction products in agricultural products manufacturing, vinyl chloride manufacturing, and other basic organic and inorganic chemical manufacturing; • Repackaging for use as a laboratory chemical; • Recycling; • Industrial and commercial use as an industrial processing aid in the manufacture of agricultural products and vinyl chloride; • Industrial and commercial use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine; and • Disposal. (2) Require use of laboratory ventilation devices, such as fume hoods or glove boxes, and dermal personal protective equipment (PPE) for the industrial and commercial use as a laboratory chemical, as outlined in Unit IV.C.; (3) Prohibit these additional conditions of use, for which the Agency understands use of CTC has already ceased, as outlined in Unit IV.D.: • Incorporation into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride (for which EPA is requiring a WCPP); • Industrial and commercial use as an industrial processing aid in the manufacture of petrochemicals-derived products except in the manufacture of vinyl chloride (for which EPA is requiring a WCPP); • Industrial and commercial use in the manufacture of other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings), except for use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine (for which EPA is requiring a WCPP); • Industrial and commercial use in metal recovery; • Industrial and commercial use as an additive; and • Industrial and commercial use in specialty uses by the U.S. Department of Defense (DoD). (4) Require recordkeeping, as outlined in Unit IV.E.1. (5) Require manufacturers (including importers), processors, and distributors to provide downstream notification of the requirements, as outlined in Unit IV.E.2. EPA notes that not all TSCA conditions of use of CTC are subject to this final rule. “Conditions of use” is defined in TSCA section 3(4) to mean the circumstances, as determined by EPA, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. As described in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) and the 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride (Ref. 3), two conditions of use of CTC do not drive the unreasonable risk: distribution in commerce and processing as a reactant/intermediate in reactive ion etching. EPA is not finalizing any restrictions for the processing of CTC as a reactant/intermediate in reactive ion etching. However, under TSCA section 6(a), EPA may select from among a suite of risk management requirements in TSCA section 6(a), including requirements related to distribution in commerce, as part of its regulatory options to address the unreasonable risk; EPA's final regulatory action includes prohibitions on the distribution in commerce of CTC for certain downstream conditions of use to address unreasonable risk from those downstream conditions of use. Additionally, as explained in Section 1.4.2.3 of the 2020 Risk Evaluation for Carbon Tetrachloride and Section 2.2.2.1 of the 2018 Problem Formulation of the Risk Evaluation for Carbon Tetrachloride, EPA concluded that the industrial/commercial/consumer uses of CTC in adhesives/sealants, paints/coatings, and cleaning/degreasing solvent products contain only trace amounts of CTC, present only de minimis exposures or otherwise insignificant risks under TSCA, and did not warrant inclusion in the risk evaluation. Therefore, EPA has excluded from the rule's requirements CTC that is solely present unintentionally in trace quantities with another chemical substance or mixture, whether as a manufacturing residue, unreacted feedstock, byproduct, or other contaminant. However, EPA notes that the Agency has discretion to further assess trace quantities of CTC under other regulatory authorities, such as the Clean Air Act. Finally, manufacture of CTC as a byproduct was not evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1); therefore, in this final rule, WCPP requirements applicable to the domestic manufacture of CTC do not apply where CTC is manufactured solely as a byproduct. EPA anticipates that any risks presented by the presence of CTC as a byproduct formed during the manufacturing, processing or use of a parent compound will be considered in the scope of the risk evaluation of such parent compound. For example, EPA will assess the risks of CTC manufactured as a byproduct during the manufacture of 1,2-dichloroethane in the TSCA risk evaluation for 1,2-dichloroethane (Ref. 1). D. Why is the Agency taking this action? Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk.” CTC was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in December 2022 (Ref. 3), determining that CTC, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. On July 28, 2023, EPA issued a proposed rulemaking (88 FR 49180) (FRL-8206-01-OCSPP) under TSCA section 6(a) to take action to the extent necessary so that CTC no longer presents such risk. The Agency received public comment on the proposal. With this action, EPA is finalizing with modifications the July 2023 proposed rule so that CTC no longer presents an such risk. The conditions of use that contribute to the unreasonable risk from CTC are described in the proposed rule (88 FR 49190) (FRL-8206-01-OCSPP) and Unit IV. CTC's hazards are well established. EPA's 2020 Risk Evaluation for Carbon Tetrachloride considered the hazards associated with exposure to CTC and determined that CTC presents an unreasonable risk of injury to health due to the significant adverse health effects associated with the exposure of CTC. While some risks of adverse effects from CTC exposure are associated with acute single exposures, other risks are associated with long-term repeated exposures. EPA identified cancer and liver toxicity adverse effects from chronic inhalation and dermal exposures as well as liver toxicity from acute dermal exposures to CTC (Refs. 1, 2, 3). Cancer adverse effects ( e.g., liver, pheochromocytoma, neuroblastoma) were identified for chronic inhalation and dermal exposures. Cancer was selected based on the best available science and weight of scientific evidence, and in consideration of the severity of hazards, magnitude of exposure, population exposed, and uncertainties in the November 2020 Risk Evaluation for Carbon Tetrachloride and the December 2022 Revised Risk Determination for Carbon Tetrachloride. EPA identified in the 2020 Risk Evaluation for Carbon Tetrachloride a threshold cancer point of departure (POD) for liver tumors (assuming a margin of exposure of 300), and an inhalation unit risk (IUR) for adrenal tumors, based on effects observed in mice following inhalation exposure. The chronic non-cancer PODs for inhalation exposures are based on a study observing increased fatty changes in rodent livers (fatty changes in the liver are a precursor for liver fibrosis). EPA also identified additional risks associated with other adverse effects ( e.g., immediate and temporary depression of the central nervous system, kidney toxicity, reproductive and developmental toxicity, irritation and sensitization, and genetic toxicity) resulting from acute and chronic exposures. For this action, EPA has determined that protecting against liver and adrenal cancer would also address the risk for acute non-cancer, chronic non-cancer, and additional cancer risks from CTC, as identified in the 2020 Risk Evaluation for Carbon Tetrachloride and the Revised Unreasonable Risk Determination for CTC in December 2022 (Ref. 1, 2 and 3). CTC is primarily used as a feedstock to make products such as refrigerants, aerosol propellants, and foam-blowing agents. Requirements under the Montreal Protocol and Title VI of the Clean Air Act (CAA), which were included in the CAA Amendments of 1990 and are codified at 42 U.S.C. Chapter 85, Subchapter VI, led to a phaseout of CTC production in the United States for most non-feedstock domestic uses, such as degreasers and fire suppressants. In addition, the Consumer Product Safety Commission (CPSC) banned the use of CTC in household ( i.e., consumer) products (excluding unavoidable residues not exceeding 10 ppm atmospheric concentration) in 1970 (see 16 CFR 1500.17(a)(2)). The Agency has considered the benefits of CTC for various uses as required under TSCA section 6(c)(2)(A) and (B) and recognizes that continued use of CTC for some TSCA conditions of use should be maintained for several reasons. The use of CTC may provide benefits that complement the Agency's efforts to address climate-damaging HFCs under the AIM Act and the Kigali Amendment to the Montreal Protocol, supporting human health and environmental protection under these programs. In addition, the use of CTC may provide other benefits due to certain unique properties of CTC ( e.g., it does not react with the process gasses when used as a process agent in the manufacture of agricultural products (Ref. 4)). Finally, strict workplace controls can be implemented to address unreasonable risk across many conditions of use. For some workplaces, EPA understands that existing controls may already reduce exposures enough to meet the inhalation exposure concentration limit proposed in this rulemaking or to prevent direct dermal contact with CTC. For many of the conditions of use for which EPA is finalizing workplace controls under a WCPP, data indicating that certain uses could meet the exposure limit and ancillary requirements of an effective WCPP in addressing unreasonable risk were submitted during the risk evaluation, the comment period following publication of the proposed rule, or during stakeholder outreach engagements, and are available in the corresponding public dockets (EPA-HQ-OPPT-2016-0733; EPA-HQ-OPPT-2019-0499; EPA-HQ-OPPT-2020-0592). Accordingly, EPA is finalizing workplace controls to address the unreasonable risk while allowing continued use for 100% of the production volume of CTC manufactured annually, including the processing of CTC as a reactant in the production of HFOs. The rationale for the final regulatory action, including the TSCA section 6 requirements considered in developing the regulatory action, is described in Units II.D. and III. E. What are the estimated incremental impacts of this action? EPA has prepared an Economic Analysis for the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket (Ref. 5). As described in more detail in the Economic Analysis and in Unit V.D., EPA's estimate of the incremental costs of this final rule is $19.7 million per year annualized over 20 years at a 3% discount rate and $19 million per year at a 7% discount rate (Ref. 5). In response to the updated Circular A-4 published in November 2023, the incremental costs of this rule at a 2% discount rate ($19.9 million annualized over 20 years) are provided in Appendix C of the Economic Analysis (Ref. 5). These costs include compliance with a WCPP for certain conditions of use, applicable PPE requirements, and notification and recordkeeping costs. EPA was not able to quantify the costs associated with administrative and engineering controls because they are site-specific and depend on the extent to which controls are already in place, which is likely to vary across individual facilities. Thus, for the purpose of estimating costs and benefits, this analysis assumes that PPE is used. Under the WCPP, regulated entities would be required to consider respirators and dermal PPE only after consideration of other more effective strategies in the hierarchy of controls adopted by the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) to reduce exposures (Ref. 6). Regulated entities are required first to consider other measures in the hierarchy of controls and then to select PPE based on monitoring results because the Agency recognizes that workplaces have unique processes and equipment in place, and that varying levels of respiratory Assigned Protection Factor (APFs) may be needed for different workplaces. Industry is expected to incur costs associated with performing inspections, documenting efforts to meet the regulatory requirements associated with the WCPP, including reducing exposure and occurrences of exposure, monitoring, respirators and dermal PPE, training on the use of respirators and dermal PPE, and notification and recordkeeping burdens and costs associated with the WCPP. Industry is also expected to incur equipment costs associated with dermal PPE for laboratory use. EPA assumes that industry would not incur equipment costs associated with the ventilated laboratory safety requirement for laboratory settings because these requirements are part of baseline industry practices. All manufacturers (including importers), processors, and distributors will bear downstream notification and recordkeeping costs. The costs are estimated as incremental to baseline conditions, including current use of PPE. The costs represent a high-end estimate of the number of entities and workers affected by the regulation because the high estimates of workers and entities from the 2020 Risk Evaluation for Carbon Tetrachloride were used. To the extent that EPA's approach overestimates the number of entities subject to the regulation, actual realized costs of this action will be lower. More details regarding the provisions of the final rule are in Unit IV. In addition to the quantified costs, there is an unquantified cost to workers and firms associated with prolonged use of respirators, which could interfere with work tasks. The potential for respirator use to cause discomfort and productivity losses could lead companies to offer higher wages as compensation, but the extent of this effect is unknown and thus unquantified. The Economic Analysis contains additional information about the unquantified costs in Chapter 3 and in the Estimated Incremental Costs section of the Executive Summary (Ref. 5). Unit IV. details which actions apply to specific conditions of use. EPA estimates that 30 firms associated with 72 sites may be manufacturing (including importing), processing, or releasing CTC. EPA estimates that the final rule would affect at least seven small entities. EPA compared the highest annualized per-facility cost of the final regulatory action with ultimate parent company annual revenues of the affected small businesses. EPA found impacts under 1% of annual revenues for five of the seven small entities. Two small entities were estimated to have a cost-to-revenue impact ratio of between one and three percent. In alignment with the goals of President Biden's Cancer Moonshot, the rule will protect people from cancer and other adverse health effects of CTC (Ref. 7). The actions in this final rule are expected to achieve health benefits for the American public. The Economic Analysis monetizes benefits to occupational users and non-users of avoiding cases of adrenal and liver cancer due to reduced inhalation exposures that result from implementation of the WCPP. The magnitude of the cancer benefits from reduced inhalation exposure is estimated assuming companies provide respirators to comply. It is also possible that employees will receive respiratory benefits from other actions on OSHA's hierarchy of controls, such as engineering controls, since regulated entities are required first to consider other measures in the hierarchy of controls and then to select PPE based on monitoring results. However, the Economic Analysis does not estimate the costs of such controls because feasible controls and their costs are site-specific and the amount of additional exposure reduction that could be achieved through any given type of control would depend on the extent to which such controls are already in place, which is likely to vary across individual facilities. This assumption is made for the purpose of estimating costs only and is not an assumption about how facilities would necessarily comply with WCPP requirements. Other human health benefits, including noncancer and additional cancer benefits, while tangible and significant, cannot be monetized due to data and methodology limitations. These include additional cancer benefits from avoided brain tumors, noncancer health benefits, health benefits from avoided dermal exposure, and benefits to the environment. The incremental improvements in health outcomes achieved by given reductions in exposure cannot currently be quantified for non-cancer health effects associated with CTC exposure, and therefore cannot be converted into monetized benefits. Although some benefits cannot be quantified, they are not necessarily less important than the quantified benefits. The primary reason these benefits were not quantified is the difficulty in estimating the relationship between an incremental change in CTC use and the corresponding change to a specific health or environmental outcome. Adrenal and liver cancer avoidance benefits are calculated based on reductions in inhalation exposure using the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) for those uses which are continuing but with a WCPP in place. Therefore, benefits are only calculated for the WCPP in the final rule, which could include respiratory protection. The estimated monetized benefit of the final rule ranges from approximately $0.13 to $0.14 million per year annualized over 20 years at a 3% discount rate and from $0.06 to $0.07 million per year at a 7% discount rate. In response to the updated Circular A-4 published in November 2023, the incremental benefits at a 2% discount rate ($0.16 to $0.17 million annualized over 20 years) are provided in Appendix C of the Economic Analysis (Ref. 5). To estimate the costs and benefits of the WCPP, the Economic Analysis generated a likely distribution of air monitoring outcomes at CTC facilities. This distribution was used to project the number of facilities that would require each respirator APF. These estimates are subject to uncertainties, and there could be facilities with higher or lower air exposures than estimated in the Economic Analysis. Using the high-end estimates for the number of entities and workers affected by the final rule, the monetized net benefit of the final rule, which is negative, is −$19.6 million per year annualized over 20 years at a 3% discount rate and is −$18.9 million per year at a 7% discount rate. In response to the updated Circular A-4 published in November 2023, the incremental net benefits at a 2% discount rate (−$19.7 million annualized over 20 years) are provided in Appendix C of the Economic Analysis (Ref. 5). The range in the monetized net benefits estimate at each discount rate presented in the Economic Analysis reflects uncertainty in cancer risk reductions given the shorter exposure durations being considered and the life stage at which the changes in exposure occur. Although the estimated monetized net benefits are negative, there are also non-monetized benefits due to other avoided adverse health effects associated with CTC exposure, including liver, reproductive, renal, developmental, and central nervous system (CNS) toxicity endpoints. These are serious health endpoints, even though the change in risk due to CTC exposure was not quantified in the 2020 Risk Evaluation for Carbon Tetrachloride. Section 6.6 of the Economic Analysis, addressing environmental justice impacts, provides sociodemographic data on communities and workers in industries affected by the rule and people who live in proximity to potentially affected facilities. EPA analyzed the baseline conditions facing communities near CTC and HFO manufacturing facilities as well as those of workers in the same industry and county as CTC facilities and HFO manufacturing facilities. The environmental justice analysis found that, across the entire population within 1- and 3-miles of CTC facilities, there are higher percentages of people who identify as Black and living below the poverty line and a similar percentage of people who identify as Hispanic compared to the national averages. CTC facilities are concentrated in Texas and Louisiana, especially near Houston and Baton Rouge. II. Background A. Overview of Carbon Tetrachloride As described in more detail in the proposed rule, EPA identified liver and adrenal toxicity cancer adverse effects from chronic inhalation and dermal exposures, as well as liver toxicity from acute dermal exposures in the workplace as the basis for the unreasonable risk determination for CTC (Ref. 1, 2, and 3). This final rule is specifically intended to address the unreasonable risk of injury to health EPA identified in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) and the 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride (Ref. 3), as described in Unit II.C. CTC is a volatile organic compound that is primarily used as a feedstock in the production of HCFCs, HFCs, and HFOs. According to data submitted for EPA's 2016 and 2020 Chemical Data Reporting (CDR) Rule, in Reporting Years (RY) 2015 and 2019, between 100 and 250 million pounds of CTC were manufactured or imported in the United States (Refs. 5, 8, 9). CTC's use as a feedstock in the production of HCFCs, HFCs, and HFOs and the description of finalized requirements to address the unreasonable risk are described in Unit IV.B. B. Regulatory Actions Pertaining to Carbon Tetrachloride Because of its adverse health effects, CTC is subject to numerous Federal laws and regulations in the United States and is also subject to regulation by some states and other countries. A summary of EPA regulations pertaining to CTC, as well as other Federal, State, and international regulations, is provided in the docket (Refs. 1, 10). As described in more detail in Unit II.C. of EPA's proposed rule (88 FR 49184, July 28, 2023) (FRL-8206-01-OCSPP) and the Response to Public Comments document (Ref. 11), EPA considered the adequacy of the current occupational safety and health standards from the OSHA (29 CFR part 1910) for protection of workers. EPA notes that the standards for chemical hazards that OSHA promulgates under the Occupational Safety and Health (OSH Act) share a broadly similar purpose with the worker protection-related regulations that EPA promulgates under TSCA section 6(a). The control measures OSHA and EPA require to satisfy the objectives of their respective statutes may also, in many circumstances, overlap or coincide. However, there are important differences between EPA's and OSHA's regulatory approaches and jurisdiction, and EPA considers these differences when deciding whether and how to account for OSHA requirements when evaluating and addressing potential unreasonable risk to workers so that compliance requirements are clearly explained to the regulated community. TSCA risk evaluations are subject to statutory science standards, an explicit requirement to consider risks to potentially exposed or susceptible subpopulations, and a prohibition on considering costs and other non-risk factors when determining whether a chemical presents an unreasonable risk that warrants regulatory actions—all requirements that do not apply to development of OSHA regulations. As such, EPA may find unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. In addition, health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only to the extent that it is technologically and economically feasible. OSHA's legal requirement to demonstrate that its section 6(b)(5) standards are technologically and economically feasible at the time they are promulgated often precludes OSHA from imposing exposure control requirements sufficient to ensure that the chemical substance no longer presents a significant risk to workers. While it is possible in some cases that the OSHA standards for some chemicals reviewed under TSCA will eliminate unreasonable risk, based on EPA's experience thus far in conducting occupational risk assessments under TSCA, EPA believes that OSHA chemical standards would in general be unlikely to address unreasonable risk to workers within the meaning of TSCA, since TSCA section 6(b) unreasonable risk determinations may account for unreasonable risk to more sensitive endpoints and working populations than OSHA's risk evaluations typically contemplate and EPA is obligated to apply TSCA section 6(a) risk management requirements to the extent necessary so that the unreasonable risk is no longer presented. Because the requirements and application of TSCA and OSHA regulatory analyses differ, it is necessary for EPA to conduct risk evaluations and, where it finds unreasonable risk to workers, develop risk management requirements for chemical substances that OSHA also regulates, and it is expected that EPA's findings and requirements may sometimes diverge from OSHA's. Additional considerations of OSHA standards in the 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride are discussed further in the Federal Register of December 27, 2022 (87 FR 79303). EPA intends for this regulation to be as consistent as possible with OSHA regulations for toxic and hazardous substances, with additional requirements as necessary to address the unreasonable risk. Consistent with TSCA section 9(d), EPA consults and coordinates TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burdens of duplicative requirements. C. Summary of EPA's Risk Evaluation Activities on Carbon Tetrachloride EPA published the scope of the CTC risk evaluation in July 2017 (82 FR 31592) (FRL-9963-57), and, after receiving public comments, published the problem formulation on June 11, 2018 (83 FR 26998) (FRL-9978-40). In January 2020, EPA published a draft risk evaluation (85 FR 4658, January 27, 2020) (FRL-10003-92), and, after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA issued the Risk Evaluation for Carbon Tetrachloride in November 2020 in accordance with TSCA section 6(b) (Ref. 1) (85 FR 70147, November 4, 2020) (FRL-10015-51). EPA subsequently issued a draft revised TSCA unreasonable risk determination for CTC (87 FR 52766, August 29, 2022) (FRL-9948-01-OCSPP), and, after public notice and receipt of comments, published a Revised Unreasonable Risk Determination for Carbon Tetrachloride in December 2022 (Ref. 3) (87 FR 79303, December 27, 2022) (FRL-9948-02-OCSPP). The 2020 Risk Evaluation for Carbon Tetrachloride and supplemental materials are in docket EPA-HQ-OPPT-2019-0499, and the December 2022 revised unreasonable risk determination and additional materials supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0733 available at https://www.regulations.gov . 1. 2020 Risk Evaluation In the 2020 Risk Evaluation for Carbon Tetrachloride, EPA evaluated risks associated with 15 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, and disposal (Ref. 1). The conditions of use are described in Unit III.B.1. of the proposed rule (88 FR 49190) (FRL-8206-01-OCSPP) and in Unit IV. of this final rule. The 2020 Risk Evaluation for Carbon Tetrachloride identified significant adverse health effects associated with short-term and long-term exposure to CTC. A further discussion of the hazards of CTC is presented in Unit III.B.3 of the proposed rule (88 FR 49192) (FRL-8206-01-OCSPP) and in Unit V. of this final rule. 2. 2022 Revised Unreasonable Risk Determination As described in more detail in the proposed rule, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for Carbon Tetrachloride and issued a final revised unreasonable risk determination in December 2022 (Ref. 3). EPA revised the risk determination for the 2020 Risk Evaluation for Carbon Tetrachloride pursuant to TSCA section 6(b) and consistent with Executive Order 13990 (titled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 12, 13, 14). The revisions consisted of making a single risk determination for the whole-chemical substance instead of making the risk determination for each individual condition of use, which resulted in the revised risk determination superseding the prior “no unreasonable risk” determinations for specific conditions of use (Ref. 3), the withdrawal of the associated TSCA section 6(i)(1) “no unreasonable risk” order, and clarification that the risk determination does not reflect an assumption that all workers are always provided and appropriately wear personal protective equipment (PPE) (Ref. 3). EPA determined that CTC presents an unreasonable risk of injury to health, and EPA did not identify risks of injury to the environment that contribute to the unreasonable risk determination for CTC. The CTC conditions of use that contribute to EPA's determination that the chemical substance poses unreasonable risk to health are listed in the unreasonable risk determination (Ref. 3) and also in Unit III.B.1. of the proposed rule, with descriptions to aid chemical manufacturers, processors, and users in determining how their particular use or activity would be addressed under the final regulatory action. The descriptions of the conditions of use subject to this final rule are in Unit IV. The conditions of use that do not drive the unreasonable risk for CTC (distribution in commerce and processing as a reactant/intermediate in reactive ion etching) are also listed in the unreasonable risk determination (Ref. 3) and in Unit III.B.2. of the proposed rule. EPA's final rule includes prohibitions on the distribution in commerce of CTC for certain downstream uses, but does not include any restrictions for the processing as a reactant/intermediate in reactive ion etching. 3. Description of Unreasonable Risk EPA has determined that CTC presents an unreasonable risk of injury to health under the conditions of use, based on cancer and acute and chronic toxicity for non-cancer effects. As described in more detail in the proposed rule, the TSCA section 6(b) 2020 Risk Evaluation for Carbon Tetrachloride, and the July 2022 errata memorandum correcting risk estimates for acute dermal exposures, EPA identified cancer and liver toxicity adverse effects from chronic inhalation and dermal exposures as well as liver toxicity from acute dermal exposures to CTC (Refs. 1, 2, 3). Cancer adverse effects ( e.g., liver, pheochromocytoma, neuroblastoma) were identified for chronic inhalation and dermal exposures. For chronic and acute non-cancer inhalation exposure to CTC, liver toxicity due to fatty change in the liver was indicative of cellular damage and selected as the most sensitive non-cancer endpoint. EPA identified additional risks associated with other adverse effects ( e.g., immediate and temporary depression of the central nervous system, kidney toxicity, reproductive and developmental toxicity, irritation and sensitization, and genetic toxicity) resulting from acute and chronic exposures (Ref. 1). By establishing protections from liver and adrenal cancer, EPA's final rule will also prevent the unreasonable risk from other less sensitive endpoints, including acute, chronic non-cancer, and additional cancer risks from CTC (Ref. 15). EPA considered potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by the Agency, which are included in the quantitative and qualitative analyses described in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) and were considered in the determination of unreasonable risk for CTC. 4. Conditions of Use Subject to This Regulatory Action As noted in Unit I.C., “Conditions of use” is defined in TSCA section 3(4). To assist with the implementation and compliance with the final rule, in Unit IV., EPA has provided a description of the conditions of use subject to the WCPP and to prescriptive controls, as well as those conditions of use prohibited by this final rule. The descriptions provided were obtained from EPA sources such as CDR codes, the 2020 Risk Evaluation for Carbon Tetrachloride and related documents, as well as the Organisation for Economic Co-operation and Development (OECD) harmonized use codes, and stakeholder engagements. EPA received public comments requesting minor clarifications of the descriptions for some industrial and commercial uses, and EPA has clarified those descriptions in Unit IV. A description of the minor changes can be found in the response to comments document (Ref. 11) and in Unit III.E. For the purposes of this final rule, “occupational conditions of use” refers to the TSCA conditions of use described in Units IV.B.1., IV.C.1., and IV.D.1. of the final rule. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) for purposes of distinguishing exposure scenarios, the Agency clarified then and clarifies now that EPA interprets the authority Congress gave to the Agency to “regulat[e] any manner or method of commercial use” under TSCA section 6(a)(5) to reach both industrial and commercial uses. EPA further notes that this rule does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). 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; and any food, food additive, drug, cosmetic, or device, as defined in section 201 of 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. D. EPA's Proposed Rule Under TSCA Section 6(a) for Carbon Tetrachloride 1. Description of TSCA Section 6(a) Requirements Under TSCA section 6(a), if the Administrator determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to potentially exposed or susceptible subpopulation identified as relevant to the Agency's risk evaluation, under the conditions of use, EPA must by rule apply one or more of the TSCA section 6(a) requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk. The TSCA section 6(a) requirements can include one or more of the following actions alone or in combination: • Prohibit or otherwise restrict the manufacturing (including import), processing, or distribution in commerce of the substance or mixture, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (TSCA section 6(a)(1)). • Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)). • Limit the amount of the substance or mixture which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use specified (TSCA section 6(a)(2)). • Require clear and adequate minimum warnings and instructions with respect to the substance or mixture's use, distribution in commerce, or disposal, or any combination of those activities, to be marked on or accompanying the substance or mixture (TSCA section 6(a)(3)). • Require manufacturers and processors of the substance or mixture to make and retain certain records, or conduct certain monitoring or testing (TSCA section 6(a)(4)). • Prohibit or otherwise regulate any manner or method of commercial use of the substance or mixture (TSCA section 6(a)(5)). • Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture, or any article containing such substance or mixture, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (TSCA section 6(a)(6)). • Direct manufacturers or processors of the substance or mixture to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance or mixture (TSCA section 6(a)(7)). This unit summarizes the TSCA section 6 considerations for issuing regulations under TSCA section 6(a), and it is consistent with the considerations and analyses presented in the proposed rule to manage the unreasonable risk from CTC (88 FR 49180, July 28, 2023 (FRL-8206-01-OCSPP)). As required, EPA developed a proposed regulatory action and an alternative regulatory action, which are described in Units IV.A. and IV.B., respectively, of the proposed rule (88 FR 49193 through 491205 (FRL-8206-01-OCSPP)). To identify and select a regulatory action, EPA considered the two routes of exposure driving the unreasonable risk, inhalation and dermal, and the exposed populations. For occupational conditions of use, EPA considered how it could directly regulate manufacturing (including import), processing, distribution in commerce, industrial and commercial use, or disposal to address the unreasonable risk. As required by TSCA section 6(c)(2), EPA considered several factors, in addition to the identified unreasonable risk, when selecting among possible TSCA section 6(a) regulatory requirements for the proposed rule. EPA's considerations regarding TSCA section 6(c)(2) and section 6(c)(2)(A) for CTC are discussed in full in Unit VI. of the proposed rule (88 FR 49209) (FRL-8206-01-OCSPP), including the statement of effects with respect to these considerations. After review of the public comments received, EPA has revised its statement of effects considerations in Unit V. of this final rule. Additionally, as described in more detail in EPA's proposed rule in Unit V.B. (88 FR 49209) (FRL-8206-01-OCSPP), EPA considered the availability of alternatives when finalizing a prohibition or a substantial restriction (TSCA section 6(c)(2)(C)), and in setting final compliance dates in accordance with the requirements in TSCA section 6(d)(1)(B)). To the extent information was reasonably available, EPA considered pollution prevention strategies and the hierarchy of controls adopted by OSHA and the NIOSH when developing its proposed rule, with the goal of identifying risk management control methods that would be permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated community where appropriate, and EPA took into account the information presented in the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1), input from stakeholders, insight received during consultations, and anticipated compliance strategies from regulated entities. Taken together, these considerations led EPA to the proposed regulatory action and alternative action described in Unit II.D.3. The proposed rule presents additional details related to how the requirements described in Unit II.D.1. of this document were incorporated into development of the proposed rule and primary alternative action. 2. Consultations and Other Engagement a. Consultations EPA conducted consultations and outreach as part of development of the July 28, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). The Agency held a federalism consultation from December 17, 2020, until February 17, 2021, as part of the rulemaking process and pursuant to Executive Order 13132 (Ref. 16). EPA also consulted with Tribal officials (Ref. 17). The Agency held a Tribal consultation from December 7, 2020, through March 12, 2021, with meetings held on January 6 and 12, 2021 (Ref. 17). EPA received no written comments as part of this consultation. EPA's Environmental Justice (EJ) consultation occurred from February 2, 2021, through April 2, 2021 (Ref. 18). On February 2 and 18, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to Executive Orders 12898 and 14008. EPA received one written comment following the EJ meeting, in addition to oral comments provided during the consultation (Ref. 18). More information regarding the consultations is presented in Units VIII.E., VIII.F. and VIII.J. b. Other Stakeholder Consultations In addition to the formal consultations described in Unit II.D.2.a., EPA held a webinar on December 10, 2020, providing an overview of the TSCA risk management processes and the risk evaluation findings for CTC (Ref. 19). EPA also presented on the TSCA risk management process and the findings in the 2020 Risk Evaluation for Carbon Tetrachloride at a Small Business Administration (SBA) Roundtable on December 4, 2020 (Ref. 20). Attendees of these meetings were given an opportunity to voice their concerns on both the risk evaluation and risk management. Furthermore, during development of the proposed and final rule, EPA engaged in discussions with representatives from different industries, non-governmental organizations, organized labor, technical experts, and users of CTC, including a webinar providing an overview of the proposed rule. A list of external meetings held during the development of the 2023 proposed and final rule is available in the docket (Ref. 21); meeting materials and summaries are also in the docket. c. Children's Environmental Health The Agency's 2021 Policy on Children's Health (Ref. 22) requires EPA to protect children from environmental exposures by consistently and explicitly considering early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health in all human health decisions through identifying and integrating children's health data and information when conducting risk assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk evaluations “to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment . . . including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” In addition, TSCA section 6(a) requires EPA to apply one or more risk management requirements under TSCA section 6(a) so that CTC no longer presents an unreasonable risk (which includes unreasonable risk to any relevant potentially exposed or susceptible subpopulation). Information on how the Policy was applied and on the health and risk assessments supporting this action is available under Units II.C. II.D. and V.A., as well as in Unit III.A.3. of the July 2023 proposed rule (88 FR 49184 through 49188, 49205 through 49208 and 49190) (FRL-8206-01-OCSPP), the 2020 Risk Evaluation for Carbon Tetrachloride, and the Economic Analysis for this rule (Refs. 1, 5). 3. Proposed Regulatory Action EPA's proposed rule under TSCA section 6(a) to address the unreasonable risk presented by CTC under its conditions of use included the following: • Requirements for strict workplace controls, including a CTC WCPP, which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact with CTC, for 9 occupational conditions of use; • Requirements for prescriptive workplace controls for laboratory use; and • Prohibition of certain processing, industrial, and commercial conditions of use and the manufacture, processing, and distribution for those uses. The proposed rule included timeframes for implementation. The prohibitions EPA proposed would take effect six months after the date of publication of the final rule, except for the prohibition of the industrial and commercial use of CTC in specialty uses by the Department of Defense, which would take effect one year after the date of publication of the final rule. Likewise, for the WCPP, EPA proposed timeframes for phases of compliance, beginning with monitoring at six months and full implementation after 12 months, as described in Unit IV.A.1. of the proposed rule. EPA also proposed a compliance timeframe of six months for prescriptive controls for laboratory use. Under TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA is mandated to consider one or more alternative regulatory actions. The primary alternative regulatory action was included in the proposed rule in Unit IV.B. (88 FR 49204) (FRL-8206-01-OCSPP). Similar to the proposed regulatory action, the primary alternative regulatory action combined requirements for a WCPP and prescriptive controls to address the unreasonable risk from CTC under its conditions of use. The primary alternative regulatory action included prescriptive workplace controls, specifically respirators and dermal PPE, for the conditions of use for which EPA had proposed a WCPP. The primary alternative action also included a WCPP for processing, industrial, and commercial uses of CTC that EPA had proposed to prohibit. At the time of proposal, EPA did not have reasonably available information indicating that any of the uses proposed for prohibition were ongoing. EPA requested comment on whether any of the uses the Agency proposed to prohibit are ongoing and if EPA should consider a WCPP for those conditions of use of CTC. For the industrial and commercial use of CTC as a laboratory chemical, the primary alternative regulatory action considered by EPA included the implementation of only the requirements of Direct Dermal Contact Controls (DDCC) of the WCPP in combination with the use of fume hoods in workplace laboratory settings and advanced engineering controls specifically for DoD's use of CTC as a laboratory chemical in chemical weapons destruction. The compliance timeframes for the controls as part of the primary alternative regulatory action were the same as the timeframes proposed. For a comprehensive overview of the primary alternative regulatory action refer to Unit IV.B. of the proposed rule, with the rationale for the primary alternative regulatory action provided in Unit V.A.4. of the proposed rule (88 FR 49205 through 49208) (FRL-8206-01-OCSPP). 4. Public Comments Received EPA requested comment on all aspects of the proposed rule. During the public comment period, EPA held a webinar on August 15, 2023, providing an overview of the proposed rule and TSCA section 6; during the webinar, members of the public had the opportunity to share their perspectives (Ref. 23). The comment period closed on September 11, 2023. EPA received 23 public comments, with a majority received from industry trade organizations. The public comments also include comments from chemical manufacturers, advocacy organizations, laboratory users, a union, an academic institution, members of the regulated community, and individual residents. A summary of the comments as well as EPA's responses is in the docket for this rulemaking (Ref. 11). Additionally, Unit III. contains summaries of public comments that informed EPA's regulatory approach in this final rule. After the close of the public comment period for the proposed rule, stakeholders, including affected industry and interested groups, requested meetings with EPA. Topics of these meetings included exposure controls, process descriptions, monitoring data, and specific conditions of use. EPA received data as part of and following these stakeholder meetings and has made the information available to the public in the rulemaking docket (EPA-HQ-OPPT-2020-0592) (Ref. 21). After review of the public comments received from the proposed rule, EPA revised certain preliminary considerations that impacted which conditions of use were proposed by EPA to be prohibited or that could continue under the WCPP or prescriptive controls (Ref. 11). Similarly, based on public comments received, EPA modified for this final rule several proposed compliance timeframes, with details in Unit III. III. Changes From the Proposed Rule Unit III. summarizes the main changes from the proposed rule to the final rule, based on the consideration of the public comments. A. Changes to Requirements for Certain Conditions of Use As described in Unit III.A.1., when compared to the proposed rule, EPA's final rule no longer prohibits two sub- uses, under two separate conditions of use that were proposed for prohibition, and now allows them to continue under the WCPP. In addition, this final rule broadens the type of prescriptive controls required for one condition of use (Unit III.A.2.), as compared to the proposed rule. The rationale for these changes is described in this unit. EPA emphasizes that implementation of the WCPP or prescriptive controls can fully address the unreasonable risk from CTC for these conditions of use, and that these changes do not significantly impact the production volume of CTC expected to remain in commerce when compared to the proposed regulatory action. Taken together, EPA estimates that there are 10 facilities involved in the changes of the requirements to the conditions of use described in Units III.A.1. and 2., nine of which use CTC for the industrial and commercial use as a laboratory chemical. In addition, EPA understands that small quantities of CTC are used for the sub-uses that will continue under the WCPP instead of the proposed prohibition (Ref. 24). The two sub-uses which will continue under the WCPP account for approximately 0.4% to 1% of total production volume, based on a comparison of 2019 CDR data on CTC production volume (between 100 million and 250 million lbs.) and information reported to EPA regarding the two sub-uses (Ref. 5, Ref. 24). 1. Changes to the Prohibition of Certain Conditions of Use EPA's primary alternative regulatory action described in the proposed rule considered regulating several conditions of use under the WCPP as an alternative to the proposed prohibition, including incorporation into formulation, mixtures, or reaction products in petrochemicals-derived manufacturing, and industrial and commercial use as an industrial processing aid in the manufacture of petrochemicals-derived products. In addition, EPA requested comment on whether the Agency should require a WCPP or prescriptive controls, including respirators and dermal PPE, for any of the conditions of use EPA proposed to prohibit. EPA is finalizing a WCPP for incorporation into formulation, mixtures, or reaction products in vinyl chloride manufacturing and the industrial and commercial use as an industrial processing aid in the manufacture of vinyl chloride, as included in the primary alternative regulatory action of EPA's proposal under the broader categories of processing: incorporation into formulation, mixtures, or reaction products in petrochemical-derived manufacturing and industrial and commercial use as an industrial processing aid in the manufacture of petrochemical-derived products. EPA proposed to prohibit these sub-uses of CTC due to the lack of information indicating that these uses are ongoing, but requested comment on whether CTC is still used in these and other conditions of use EPA proposed to prohibit, and stated that if EPA received information indicating the continued use of CTC for these conditions of use, the Agency would consider regulating these uses rather than prohibiting them (88 FR at 49202 through 49203, 49205, and 49218). EPA received comments from one entity indicating that the incorporation of CTC into formulation, mixtures, or reaction products in vinyl chloride manufacturing and the industrial and commercial use of CTC as an industrial processing aid in the manufacture of vinyl chloride are ongoing (Ref. 24). The entity indicated that switching to an alternative chemical or process would require replacement of existing infrastructure and result in the temporary loss of revenue. The entity using CTC for these uses provided manufacturing data used in the 2020 Risk Evaluation for Carbon Tetrachloride, indicating that CTC is used by this entity in industrialized and standardized settings that can meet the requirements of the WCPP. Therefore, EPA understands that the entity is able to meet the WCPP requirements for processing: incorporation into formulation, mixtures, or reaction products in vinyl chloride manufacturing and the industrial and commercial use as an industrial processing aid in the manufacture of vinyl chloride as well. Furthermore, EPA understands as a general matter that these uses would occur in highly industrialized settings and controlled and closed processes, suggesting a WCPP could be successfully implemented such that risk of injury to health presented by CTC is no longer unreasonable. CTC was used in other petrochemical-derived manufacturing (other than vinyl chloride manufacturing); however, based on the reasonably available information, such uses of CTC do not appear to be ongoing. Therefore, EPA has concluded that industry has already found feasible alternatives to CTC for these uses, EPA is prohibiting processing: incorporation into formulation, mixtures, or reaction products in the remainder of petrochemical-derived manufacturing and the industrial and commercial use of CTC as a processing aid in the manufacture of remaining petrochemical-derived products, as proposed, to address the unreasonable risk contributed by these conditions of use. 2. Changes to Restrictions: Prescriptive Controls for Industrial and Commercial Use as a Laboratory Chemical In general, EPA is finalizing the prescriptive control requirements for the industrial and commercial use of CTC as a laboratory chemical as proposed, with some modifications based on consideration of public comments. As described in the proposed rule, to address the unreasonable risk of injury to health resulting from dermal exposures to CTC for the industrial and commercial use as a laboratory chemical, EPA proposed to require dermal PPE in combination with comprehensive training for tasks related to the use of CTC in a laboratory setting for each potentially exposed person in direct dermal contact with CTC. EPA also proposed to require the use of fume hoods to codify the assumption of existing good laboratory practices that EPA relied upon as a key basis for its evaluation of risk from this condition of use (Ref. 1). EPA requested comment relative to the ability of owners and operators to implement laboratory chemical fume hood and dermal PPE related requirements within six months of publication of the final rule. Under the primary alternative regulatory action, EPA included DDCC for laboratory use and solicited comment on non-prescriptive requirements of DDCC as compared to the prescriptive workplace controls of dermal PPE. EPA received several comments regarding the industrial and commercial use as a laboratory chemical. One commenter stated that the proposed regulation would result in confusion and duplication with the OSHA standard for occupational exposure to hazardous chemicals in laboratories under 29 CFR 1910.1450 that is already in effect (Ref. 25). A couple of commenters urged EPA to align its requirements for laboratory use of CTC more closely with the OSHA's laboratory standard to reduce compliance burden (Refs. 25, 26). Commenters also requested that EPA include flexibility for engineering controls beyond a fume hood for consistency with the OSHA lab standard, stating that, while fume hoods are considered best practice and commonly used to reduce exposure in laboratories, experiment designs utilizing CTC may not be able to be accommodated within a fume hood (Refs. 25, 27). Commenters described other alternative controls that can be designed and implemented to reduce exposure, such as glove boxes, exhausted enclosures, ducted biosafety cabinets, and filtration devices. Based on information provided by commenters related to exposure mitigation controls to comply with the OSHA laboratory standard and best management practices available to laboratories, EPA has determined that requiring laboratory ventilation devices such as fume hoods or glove boxes, would better align with the OSHA laboratory standard and existing good laboratory practices. As described in Unit V.A.2. the proposed rule (88 FR 49201, July 28, 2023) (FRL-8206-01-OCSPP), EPA proposed to require fume hoods in laboratory settings to codify assumptions made in the 2020 Risk Evaluation for CTC, where EPA's risk estimates and determination that inhalation exposures from the industrial and commercial use of CTC as a laboratory chemical did not contribute to the unreasonable risk were predicated on its findings that expected safety practices of using CTC in small amounts under a fume hood reduce the potential for inhalation exposures (Ref. 1). In addition to fume hoods, EPA has determined that other types of ventilation systems or containment devices, when used in compliance with the OSHA laboratory standard at 29 CFR 1910.1450(e)(3), may minimize inhalation exposures in a laboratory setting consistent with the qualitative assumption in the 2020 Risk Evaluation for CTC that the potential for inhalation exposure is low due to expected use of a fume hood. For the industrial and commercial use as a laboratory chemical, EPA concurs with the commenters that indicated EPA's requirements should align more closely with the OSHA laboratory standard wherever possible to prevent confusion. The requirement in this final rule that laboratory ventilation safety devices, such as fume hoods or glove boxes, are in use and functioning properly and that specific measures are taken to ensure proper and adequate performance of such equipment to minimize exposures to persons in the area when CTC is used in a laboratory setting aligns with existing requirements from the OSHA laboratory standard at 29 CFR 1910.1450(e)(3)(iii) while remaining consistent with the assumptions made in the 2020 Risk Evaluation. As detailed in Unit IV.C. of this final rule, EPA is finalizing the requirements for dermal PPE in combination with comprehensive training for tasks related to the use of CTC in a laboratory setting as proposed. EPA believes these requirements align with OSHA's laboratory standard and OSHA's General Requirements for Personal Protective Equipment at 29 CFR 1910.132 to the extent possible while still addressing the unreasonable risk of injury to health resulting from dermal exposures to CTC identified for the industrial and commercial use as a laboratory chemical. B. Changes to WCPP Timeframes For the conditions of use for which EPA proposed the WCPP, EPA proposed several compliance timeframes, including the following requirements: that initial exposure monitoring be conducted within six months of publication of the final rule in the Federal Register (or within 30 days of introduction of CTC into the workplace if CTC use commences at least six months after the date of publication); that each owner or operator ensure that the exposure to CTC does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons within nine months of publication of the final rule in the Federal Register ; and that owners and operators implement an exposure control plan within 12 months of publication of the final rule in the Federal Register . EPA requested comment regarding the ability of owners or operators to comply with the various provisions of the WCPP, including initial exposure monitoring, within the compliance timelines included in the proposal, and anticipated timelines necessary for any procedural adjustments needed to comply with the establishment of a respiratory protection program and development of an exposure control plan. EPA also requested comment regarding the amount of time, if any, it would take the regulated community to develop a method to measure at or below the ECEL over an entire work shift and information on what levels of detection are possible over an entire work shift based on existing monitoring methods, justification for the timeframe of the specific steps needed to develop a more sensitive monitoring method, cost associated with a more sensitive monitoring method, and any additional detailed information related to establishing a monitoring program to reliably measure CTC at or below the ECEL. Public comments highlighted challenges with the proposed timeframes and suggested longer timeframes for initial exposure monitoring. For example, one commenter stated that the proposed 6-month timeframe to conduct initial exposure monitoring may not be possible because CTC use may be infrequent and only occur annually or even less frequently, such as maintenance exercises (Ref. 28). Other commenters expressed concern that requirements to comply with a new exposure limit will stress industrial hygiene consultants and laboratories that analyze the samples, and urged EPA to ensure that there is adequate time for consultant firms and laboratories to establish sufficient capacity (Refs. 29, 30, 31). Several commenters stated that the proposed 6-month timeframe for initial monitoring would be untenable and suggested that the deadline be extended to 18 months (Refs. 29, 30, 32). One commenter stated that owners or operators should be given sufficient time to implement any new requirements which could involve substantial investments (Ref. 27). Two of the commenters reasoned that, particularly for CTC, at least 18 months is necessary to revalidate methods and determine whether revision to corporate exposure assessment strategy is necessary to address the new ECEL, including to address the specific implementation and technical feasibility challenges of measuring the CTC ECEL for both full shift and task measurements (Refs. 29, 30). One commenter indicated that they need to develop methods to achieve the detection limit for the proposed ECEL and ECEL action level, to procure professional services to implement the requirements, and most likely require laboratory analytical support (Ref. 33). Additionally, one commenter expressed concern that corporate and facility industrial hygiene resources as well as third party laboratories may also be conducting a reassessment and analysis for the methylene chloride and PCE rules recently promulgated under TSCA section 6(a), thereby requiring additional time for CTC (Ref. 29). In consideration of public comments and the challenges of initiating the WCPP, even for facilities with industrial hygiene programs in place, and the difference in the occupational exposure limits between the OSHA permissible exposure limit (PEL) and the EPA ECEL and the challenges associated with monitoring to new, lower EPA exposure thresholds that may spur an increase in the need for monitoring or other exposure control assessment infrastructure, EPA has determined that a longer compliance deadline of 540 days is as soon as practicable to conduct initial monitoring for CTC, which likely would require regulated entities to contract new services or realign current industrial hygiene professionals towards WCPP compliance. Providing 540 days for initial monitoring is intended to (1) prevent professional safety service sectors from being overwhelmed by new EPA requirements; (2) provide time to procure the necessary services while ensuring the preservation of safety quality, standards, and practices; and (3) provide sufficient time for a comprehensive exposure evaluation, increasing the likelihood of successful implementation of the WCPP. Following initial monitoring, EPA is finalizing the requirement that each owner or operator supply a respirator to each person who enters a regulated area within three months after the receipt of any exposure monitoring that indicates exposures exceeding the ECEL. Therefore, each owner or operator must ensure that the exposures to CTC do not exceed the ECEL as an 8-hour TWA for all potentially exposed persons, including by providing respiratory protection, no later than 630 days after December 18, 2024. Given the full WCPP requirements (including the exposure control plan) are required after owners or operators are required to ensure that no person is exposed to an airborne concentration that exceeds the TWA ECEL, EPA acknowledges that compliance with the ECEL may include temporary PPE use ( e.g., respiratory protection) until comprehensive engineering and administrative controls are fully implemented. As described in the proposed rule, EPA believes that three months after receipt of exposure monitoring results is as soon as practicable, while also providing a reasonable transition period for entities to evaluate exposure monitoring results, acquire the correct respiratory protection, and establish the PPE program, including training, fit-testing, and medical evaluation. EPA also received public comment regarding the compliance timeframe for full implementation of the WCPP, including detailing the evaluation steps that would be required to assess a facility and develop, document, and implement an exposure control plan. To allow time for orderly transitions and training to comply with an ECEL (0.03 ppm (8-hr TWA)) that is significantly lower than the OSHA PEL of 10 ppm (8-hr TWA) and the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV) of 5 ppm (8-hr TWA) for CTC, two commenters suggested that EPA adopt a graduated implementation approach for ECEL implementation by first requiring entities that already meet the OSHA PEL to comply with the ACGIH TLV within two years from the effective date of the final rule and then permitting those facilities meeting the ACGIH standard three years to transition to the ECEL (Refs. 34, 35). Two commenters expressed concern that the proposed timeframes would be insufficient for owners or operators to document their efforts to implement the hierarchy of controls as required under the WCPP, and recommended that the time required to develop the exposure control plan be extended to two years from completion of initial monitoring, for a total of 24 to 36 months from the effective date of the final rule, to provide adequate time for entities to evaluate and implement appropriate compliance approaches that provide flexibility and are the most effective for protecting workers (Refs. 29, 30). Based on comments, outreach, reasonably available information, and existing OSHA standards, EPA maintains that the majority of the exposure reduction and worker safety infrastructure needed for compliance is currently in place, but recognizes the fundamental challenge of building a new exposure control strategy around the new, lower EPA exposure limit. Additionally, based on consideration of public comment and given that OSHA has not promulgated a detailed standard specific to CTC, EPA has determined that a longer compliance timeframe of 1080 days for development and implementation of an exposure control plan is as soon as practicable to ensure that the regulated community has adequate time to evaluate monitoring data, assess and develop an exposure strategy, procure appropriate control technology and PPE, and implement the required chemical safety program for CTC. Therefore, EPA is finalizing the compliance timeframes for the WCPP provisions as follows: (1) The requirements for each owner or operator to conduct initial baseline monitoring must be met within 540 days after December 18, 2024, or within 30 days of introduction of CTC into the workplace, whichever is later; (2) the requirements for each owner or operator to ensure that exposure to CTC does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons, including by providing respiratory protection to all potentially exposed persons in the regulated area must be met within 630 days after December 18, 2024, or within three months after receipt of the results of any exposure monitoring that indicates exposures exceeding the ECEL; and (3) the requirements for development and implementation of an exposure control plan must be met within 1,080 days after December 18, 2024. For greater clarity in this final rule, EPA is also finalizing with slight modification the requirement that owners and operators institute a training and information program for potentially exposed persons and assure their participation in the training and information program, and that this requirement be met within 630 days after December 18, 2024 (see Unit IV.B.7.a.). EPA understands that certain departments and agencies of the Federal government, as well as Federal contractors acting for or on behalf of the Federal government, need additional time to comply with these timeframes. For example, complying with these timeframes could impact the ability of the Department of Energy (DOE) to perform sampling and groundwater treatment at contaminated plumes and wastewater treatment facilities. While, for example, 29 CFR part 1960 sets forth procedures and guidelines for ensuring that Federal workers are protected in comparable ways to their non-Federal counterparts, EPA believes that compliance with this final rule will require increased and different preparations on the part of Federal agencies. For example, Federal agencies must follow procurement requirements, which will likely result in increased compliance timelines. In addition, these requirements will require support in the Federal budget, which, for some agencies, is a multi-year process. Therefore, EPA is providing additional time for agencies of the Federal government and their contractors, when acting for or on behalf of the Federal government, to comply with the WCPP provisions as follows: (1) The requirements for each owner or operator to conduct initial baseline monitoring must be met within 915 days after December 18, 2024, or within 30 days of introduction of CTC into the workplace, whichever is later; (2) the requirements for each owner or operator to ensure that exposure to CTC does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons, including by providing respiratory protection to all potentially exposed persons in the regulated area, must be met within 1,005 days after December 18, 2024, or within three months after receipt of the results of any exposure monitoring that indicates exposures exceeding the ECEL; (3) the requirements for each owner or operator to ensure all persons are separated, distanced, physically removed, or isolated from direct dermal contact with CTC, including by providing dermal PPE, must be met within 1,005 days after December 18, 2024; (4) the requirements for development and implementation of an exposure control plan must be met within 1,080 days after December 18, 2024; and (5) the requirement that owners or operators of workplaces subject to the WCPP institute a training and information program for potentially exposed persons and assure their participation in the training and information program within 1,005 days after the date of publication of the final rule in the Federal Register ( i.e., no later than September 20, 2027). C. Changes to WCPP Requirements 1. Exposure Monitoring Requirements As part of the WCPP, EPA proposed to require owners or operators meet certain documentation requirements for each monitoring event of CTC, including compliance with the Good Laboratory Practice (GLP) Standards in accordance with 40 CFR part 792. Numerous commenters expressed concern regarding the requirement that the WCPP include compliance with the GLP Standards (Refs. 28, 29, 30, 31, 35, 36). Commenters stated that it is atypical, for industrial hygiene purposes, to use this standard for air sampling of CTC (Refs. 29, 30, 31). According to the commenters, it is common practice within the industrial hygiene community to have analyses performed by American Industrial Hygiene Association (AIHA) accredited labs (Ref. 29). One commenter added that collection of occupational monitoring samples need not be conducted under the GLP Standards where planning and collection is overseen by a Certified Industrial Hygienist or Environmental Professional as defined at 40 CFR 312.10 (Refs. 30, 31). Commenters also suggested applying the policy described in typical TSCA section 5(e) orders that establish a New Chemical Exposure Limit (NCEL) under the TSCA New Chemicals Program, which states that compliance with GLP Standards is not required where exposure monitoring samples are analyzed by a laboratory accredited by either: (A) the AIHA Industrial Hygiene Laboratory Accreditation Program; or (B) another comparable program approved in advance in writing by EPA (Refs. 29, 30, 31). Another commenter reasoned that GLP Standards were not intended for air monitoring in a workplace when compliance with such standards would mean that real-time assessments could not be made, as air samples would need to be processed and analyzed in a laboratory (Ref. 28). EPA agrees with the commenter that the WCPP is incompletely served by solely relying on the GLP Standards initially put forth in the July 29, 2023 proposed rule (88 FR 49180) (FRL-8206-01-OCSPP). Given the concern from commenters regarding potential increases in demand for professional safety services and sampling laboratories having a negative impact due to anticipated industry strain and sampling limitations (Refs. 29, 30, 31), EPA has broadened the scope of laboratory accreditation accordingly. EPA has considered this laboratory capacity issue, in addition to other revisions for finalization in this rule, so that the additional infrastructure is in place for the regulated community to successfully implement the WCPP. For the final rule, EPA is requiring that exposure samples be analyzed using an appropriate analytical method, and related records retained, by a laboratory that complies with the GLP Standards in 40 CFR part 792 or that otherwise maintains a relevant third-party laboratory accreditation ( e.g., under the AIHA Laboratory Accreditation Programs, LLC Policy Module 2A/B/E of Revision 17.3), or other analogous industry-recognized programs. Another commenter stated that EPA's proposal did not make clear that “personal breathing zone” air samples to monitor exposures are to be taken without regard to respirator use. The commenter noted that OSHA requires exposure monitoring to be conducted without regard to respirator use (citing as an example OSHA's definition of “employee exposure” at 29 CFR 1910.1052(b)) and asserted that this important element of OSHA's monitoring program was omitted from EPA's proposal (Ref. 37). EPA agrees with the commenter that exposure monitoring should be conducted without regard to respiratory protection to inform engineering control options and respiratory protection considerations. Therefore, EPA is finalizing this rule to explicitly state that air sampling is required to measure ambient concentrations for CTC without taking respiratory protections into account when being performed. This will ensure the appropriate degree of protection to potentially exposed persons by logging accurate ambient air concentrations of CTC, thus empowering owners or operators to appropriately consider the hierarchy of controls. Additionally, as part of the WCPP, EPA proposed to require owners and operators to re-monitor within 15 working days after receipt of any exposure monitoring when results indicated non-detect, unless an Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist reviews the monitoring results and determines re-monitoring is not necessary. EPA received several comments disagreeing with the proposed requirement to review non-detect air monitoring samples. The commenters stated that facilities use accredited labs to perform industrial hygiene sampling analysis, the results are reviewed by industrial hygiene professionals, and it is an unnecessary step that adds no value to reduce risk to workers (Refs. 29, 30, 31). EPA disagrees with commenters that expressed the opinion that re-evaluating a non-detect result adds no value and is inappropriate. While in some cases a non-detect result may accurately indicate that the chemical is not present and that air concentrations are below the ECEL action level, in other cases it may not necessarily imply negligible occupational exposure to the chemical. For example, interference from another chemical during sampling may result in an incorrect result of non-detect. This interference may not be recognized at the time of sampling or analysis. Owners and/or operators also may not be using sampling techniques or analytical procedures that are effective or appropriate for the particular chemical of interest. In each of these cases, non-detect results, along with supporting documentation about the sampling and analytical methods used to get those results, is a meaningful part of the potentially exposed person's exposure record required under the WCPP. The WCPP in the proposed rule and in this final rule does not require re-monitoring in all cases. Re-monitoring may be necessary based on a professional evaluation by an Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist. This flexibility allows owners or operators options in terms of revisiting occupational sampling in the event of a non-detect result, or evaluation by a qualified professional. EPA determined that a non-detect sampling result when effective sampling and analysis procedures are used is valuable to an owner/operator in that it suggests effective implementation of exposure controls. Potentially exposed persons may also use these records in discussions with owner/operators, in collective bargaining situations, or in compliance assistance inquiries to EPA or other federal agencies. Exposure monitoring results may also improve overall workplace health and reducing owner/operator liability in the effective detection, treatment, and prevention of occupational disease or illness. All of the above scenarios are valuable for owner/operators, potentially exposed persons, and for effective mitigation of occupational exposures. In consideration of these factors, EPA has removed the air monitoring equipment malfunction from the monitoring activities that do not require resampling based on professional evaluation by an Environmental Professional or Certified Industrial Hygienist. While professional discretion may be warranted in determining whether re-monitoring is needed following results that indicate non-detect, EPA has determined this is not appropriate in the event of air monitoring equipment malfunction. This is due to the importance of air monitoring in ensuring that the requirements of the WCPP are met, and the importance of the WCPP in reducing risks from exposures to CTC in the workplace. Monitoring results from malfunctioning air monitoring equipment are not valid monitoring and therefore not sufficient to meet the monitoring requirements under the WCPP. EPA may consider developing additional guidance regarding occupational monitoring in the future. Therefore, EPA is finalizing the requirement to re-monitor within 15 working days after receipt of any exposure monitoring if results indicated non-detect unless an Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist reviews the monitoring results and determines re-monitoring is not necessary. EPA has updated the recordkeeping requirements associated with the WCPP exposures records required under 40 CFR 751.713(b)(1) to require documentation of the determination by the Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist to be maintained as a record. Occupational monitoring (and associated recordkeeping) is an area that EPA may develop guidance as part of final rule implementation efforts. 2. Designated Representative EPA proposed to require owners and operators to provide potentially exposed persons regular access to the exposure control plan, exposure monitoring records, and PPE program implementation plan (documenting proper application, wear, and removal of PPE). EPA requested comment on how owners and operators could engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program. One commenter stated that employees should be engaged in the development and implementation of the exposure control plan and that the engagement is best performed during the PPE and respirator training (Ref. 27). Another commenter urged EPA to require that owners and operators consult with workers and their designated representatives in developing and implementing their plans (Ref. 37). EPA received public comment on the role of designated representatives in the WCPP. One commenter, a group of labor unions, urged EPA to incorporate requirements similar to OSHA's access standard at 29 CFR 1910.1020 (entitled, “Access to employee exposure and medical records”) in EPA's proposed recordkeeping requirements for the WCPP to ensure that exposure information is promptly and fully shared with both potentially exposed persons and their designated representatives (Ref. 37). The commenter also suggested that EPA include a requirement that employers provide employees or their designated representatives an opportunity to observe monitoring events. The commenter observed that workers and their designated representatives have a critical role to play in ensuring effective control of toxic substances and further noted that, often, unions are the organizations with expertise in understanding occupational exposure information. Following review of the comments received, EPA recognizes the importance of having the ability for potentially exposed persons and their designated representative(s), such as labor union representatives, to observe exposure monitoring and have prompt access to exposure records. EPA additionally recognizes that, in some instances, individual workers may be hesitant to ask owners or operators for information relating to their chemical exposure or may be less familiar with discipline-specific industrial hygiene practices. EPA determined that it is appropriate in this final rule to establish requirements regarding designated representatives, consistent with existing OSHA precedent in certain 29 CFR part 1910, subpart Z regulations, to allow designated representatives the ability to observe occupational exposure monitoring and have access to exposure monitoring records. In EPA's final rule, the WCPP includes a requirement that owners and operators provide potentially exposed persons or their designated representatives an opportunity to observe any exposure monitoring that is designed to characterize their exposures and is conducted under the WCPP. EPA is also finalizing a requirement that designated representatives have access to relevant exposure records, similar to provisions in certain OSHA regulations under 29 CFR part 1910, subpart Z, such as 29 CFR 1910.1200 and 29 CFR 1910.1020. EPA is requiring owners and operators to notify potentially exposed persons and their designated representatives of the availability of the exposure control plan and associated records of exposure monitoring and PPE program implementation within 30 days of the date that the exposure control plan is completed and at least annually thereafter. EPA is also requiring, consistent with the proposed requirement for notification of exposure monitoring results, that the notice of the availability of the exposure control plan and associated records be provided in plain language writing to each potentially exposed person in a language that the person understands or posted in an appropriate and accessible location outside the regulated area with an English-language version and a non-English language version representing the language of the largest group of workers who do not read English. While EPA encourages owners or operators to consult with persons that have potential for exposure and their designated representatives on the development and implementation of the exposure control plan, EPA has determined that it is not necessary to include this as a requirement in the final rule, consistent with OSHA, because the involvement of designated representatives in the observation of occupational monitoring and the potential to access exposure records being finalized in this rule provide a productive forum for communicating with owner/operators about the exposure control plan. EPA believes that the notification of the exposure control plan and associated records may help facilitate participation from potentially exposed persons and their designated representatives in the implementation and further development of that plan. EPA's final rule to address the unreasonable risk of PCE under TSCA section 6(a) (RIN 2070-AK84) established the definition of “designated representative” intended to apply to all TSCA section 6(a) requirements under 40 CFR part 751 at § 751.5. A recognized or certified collective bargaining agent must be treated automatically as a designated representative without regard to written authorization. Additionally, with respect to Federal Government employees, EPA, like OSHA at 29 CFR 1960.2(e), will interpret these designated representative requirements consistent with the Federal Service Labor Management Relations Statute (5 U.S.C. 7101 et seq. ), or collective bargaining or other labor-management arrangements that cover the affected employees. Should a request be initiated for such records by the potentially exposed person or their designated representative(s), the owner or operator will be required to provide the specified records at a reasonable time, place, and manner, analogous to provisions outlined in OSHA's 29 CFR 1910.1020(e)(1)(i). If the owner or operator is unable to provide the requested records within 15 working days, the owner or operator must, within those 15 days, inform the potentially exposed person or designated representative(s) requesting the record of the reason for the delay and the earliest date when the record will be made available. Additionally, in the event that a designated representative is observing exposure monitoring, the owner or operator must ensure that designated representatives are provided with PPE appropriate for the observation of monitoring. Finally, this rule requires owners or operators to provide notice to potentially exposed persons and their designated representatives of exposure monitoring results and of the availability of the exposure control plan and associated records. For purposes of this requirement, the owner or operator is only required to provide notice to those designated representatives that the owner or operator is aware of, such as representatives designated in writing or a recognized collective bargaining agent for the owner or operator's own employees. 3. Other Changes to the WCPP EPA proposed various requirements under the WCPP for owners or operators to provide PPE, including respiratory protection and dermal protection, to potentially exposed persons and to establish a PPE program. For greater clarity in this final rule, EPA has revised the PPE requirements with respect to the cross-references to the relevant OSHA regulations. While the language appears different than the requirements included in the proposed rule, it remains EPA's intention that owners and operators implement PPE programs that are consistent with OSHA requirements. The PPE requirements as part of the WCPP in this final rule are described in Unit IV.B.6. D. CTC Unintentionally Present in Trace Quantities in Other Chemical Substances Several public comments on the proposed rule urged EPA to establish an explicit “de minimis” weight fraction threshold or add an exemption for impurities or other contaminants from the rule's requirements for small levels of CTC present in other chemical substances or mixtures (Refs. 26, 28, 29, 30, 31, 35, 38, 39). Two commenters raised concerns that absent such exemption, the proposed prohibition on industrial and commercial use of CTC as an industrial processing aid in the manufacture of petrochemicals-derived products would inadvertently prohibit the industrial and commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing, which EPA is regulating under a WCPP in a separate TSCA section 6(a) rulemaking for PCE, because PCE contains trace amounts of CTC as an impurity or other contaminant (Refs. 26, 38). Two other commenters who supported a de minimis exclusion for impurities noted that prohibiting impurities in downstream products or CTC impurities in feedstocks could severely hamper numerous value chains and stated that establishing a de minimis weight fraction threshold of 0.1% by weight for the CTC restrictions would align with existing requirements under OSHA's Hazard Communication Standard (Refs. 30, 31). One of these commenters stated that a member company imports a product containing a very small amount of CTC as an impurity, then sells the sealed container for rubber processing; this commenter urged EPA to expressly exempt from the WCPP requirement these zero exposure and de minimis scenarios (Ref. 31). Another commenter stated that a member uses some raw materials that contain CTC, primarily chlorinated rubbers and methylene chloride, in the manufacturing of adhesives and coatings, and was concerned that this use would fall under the proposed prohibitions (Ref. 39). Another commenter asserted that any formulated products that contain de minimis concentrations of CTC ( i.e., concentrations less than 0.1% by weight) would not pose a risk and should not be covered by the rule (Ref. 29). Two other commenters recommended that EPA include both a de minimis exemption for materials in which CTC may appear at de minimis levels of less than 0.1% by weight, and an exemption for CTC present in a formulation, in an intermediate, or in an end product as an impurity or byproduct, including when present as an unintentional byproduct or impurity in an imported product (Refs. 26, 35). One commenter suggested that EPA implement a de minimis weight fraction threshold of 0.5% (Ref. 39). In the final rule, EPA has excluded from the rule's requirements CTC that is solely present unintentionally in trace quantities with another chemical substance or mixture. This exclusion is intended to cover circumstances in which another chemical substance or mixture unintentionally contains trace quantities of CTC that may be present as a manufacturing residue, unreacted feedstock, byproduct, or other contaminant. The Agency determined that this exclusion was appropriate because the conditions of use of CTC that were evaluated in the 2020 Risk Evaluation for Carbon Tetrachloride and determined to contribute to the unreasonable risk presented by CTC did not include scenarios in which trace amounts of CTC is unintentionally present in other chemical substances or mixtures. To the contrary, Section 1.4.2.3 of the Risk Evaluation stated that there were conditions of use that EPA concluded in the 2018 Problem Formulation of the Risk Evaluation for Carbon Tetrachloride would present only de minimis exposures or otherwise insignificant risks from trace amounts of CTC and did not warrant inclusion in the risk evaluation. This conclusion was related specifically to industrial/commercial/consumer uses of CTC in adhesives/sealants, paints/coatings, and cleaning/degreasing solvent products. EPA reserves the right to assess and address potential environmental and health risks of trace quantities of CTC under different authorities such as CAA Title I and VI. The 2020 Risk Evaluation for Carbon Tetrachloride explained that while CTC's use as a process agent in the manufacturing of other chlorinated compounds may result in trace levels of CTC as a manufacturing residue in the chlorinated substances used to manufacture downstream products, those trace amounts are expected to volatilize during the product manufacturing process, such that EPA expected insignificant or unmeasurable concentrations of CTC in the chlorinated substances in commercially available adhesive/sealant, paint/coating, and cleaning/degreasing products. The final rule's exclusion for CTC unintentionally present in trace quantities with another chemical substance or mixture is consistent with this earlier exclusion from the scope of the Risk Evaluation for Carbon Tetrachloride. Any product with CTC concentrations above trace quantities that falls within a condition of use regulated under this rule will be subject to the relevant rule provisions ( e.g., WCPP, prescriptive controls, or prohibition), as appropriate based on the condition of use of CTC. In addition, any potential occupational risk from the presence of trace quantities of CTC in PCE is expected to be eliminated by the recently promulgated final risk management rule for PCE under TSCA section 6(a) (to be codified at 40 CFR part 751, subpart G). The occupational and consumer protections from exposures to PCE under that final rule, which address the unreasonable risk of injury to health presented by PCE under its conditions of use, would also have the effect of reducing the risk from exposures to trace amounts of CTC that may be present in PCE. For example, the final rule requires a workplace chemical protection program with both an Existing Chemical Exposure Limit of 0.14 ppm of PCE as an 8-hr TWA and direct dermal contact control requirements for the industrial/commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing. Any engineering controls or PPE used to reduce occupational exposures to PCE for the use as a processing aid in catalyst regeneration in petrochemical manufacturing are expected to reduce workplace exposures to CTC. The limitations on inhalation and dermal exposures to PCE to prevent unreasonable risk of injury to health from that chemical substance are also expected to limit any potential exposure to trace quantities of CTC that may be unintentionally present in the PCE, reducing the risk of injury to health from the CTC, so that that condition of use does not contribute to the unreasonable risk of CTC. At this time, EPA is not establishing a specific weight fraction or other numerical threshold value for the trace quantities exclusion in the CTC final rule, consistent with existing exclusions of trace quantities of remaining substances from the definitions of “controlled substance” and “transform” under 40 CFR 82.3. Instead, the exclusion is based on the plain meaning of the term, “trace quantities.” If the CTC is intentionally retained in the chemical substance or mixture of which it is a part and provides a desired purpose, then it is not “present unintentionally in trace quantities” and would not be excluded from the rule's requirements. E. Other Changes EPA has revised its proposed description of industrial and commercial use of CTC as a laboratory chemical to provide additional clarity as suggested by a commenter (Ref. 33). The revised description for industrial and commercial use as a laboratory chemical appears in Unit IV.C.1. In addition, EPA has slightly modified the industrial and commercial use descriptions in 40 CFR 751.705(b)(1)(ii)(B), 751.707(a)(8), and 751.711(c) to clarify that the industrial and commercial use of CTC in the recovery of chlorine in tail gas from the production of chlorine falls under the WCPP rather than the prohibition on industrial and commercial use in the manufacture of other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings). In the proposed rule, EPA had intended this use of CTC to be captured with the description of “industrial and commercial use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda,” but EPA agrees with two public commenters that it would be clearer to specifically list use of CTC in the recovery of chlorine in tail gas from the production of chlorine in the regulatory text (Refs. 29, 30). EPA has revised its proposed description of disposal. Based on coordination across Federal programs, for the disposal COU, EPA has determined it is appropriate that owners and operators of cleanup sites where potentially exposed persons are involved in the disposal of CTC-containing wastewater for the purposes of cleanup projects of CTC-contaminated water and groundwater, including industrial pre-treatment and industrial treatment activities, must ensure that potentially exposed persons involved with the activity of removing the groundwater from the location where it was found and treating the removed groundwater on site comply with the WCPP. At cleanup sites, the WCPP, including the ECEL, would apply to any potentially exposed person involved in the disposal of CTC-containing groundwater, which most likely includes a worker who is involved with the activity of removing CTC- containing groundwater from the location where it was found and the on-site treatment of the groundwater, typically referred to as ex situ remediation, which is most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ remediation includes both active and passive remediation methods that span traditional ( e.g., pump and treat) and less traditional ( e.g., phytoremediation) approaches, but only if the remediation method would be considered industrial wastewater pretreatment, industrial wastewater treatment or discharge to a publicly owned treatment work (POTW). EPA generally considers workers in and around those locations to be potentially exposed persons as that term is defined in 40 CFR 751.5. For example, EPA's requirements would apply to protect workers conducting remediation through pump and treat systems or workers sampling groundwater in conjunction with groundwater extraction or treatment ( e.g., remediation or cleanup) activities. EPA considers only those treatment activities that are performed at the cleanup site on CTC-contaminated wastewater that has been removed from the subsurface, surface water impoundments, or aquifers and that are recognized as industrial treatment, industrial pretreatment, or discharge to a POTW to be covered under the provisions described in Unit IV.B. The provisions of the WCPP for the disposal COU, including the ECEL, are not intended to cover potentially exposed persons who are sampling groundwater to monitor the presence of a plume, but specifically only those sampling at the site of extraction and treatment activities. EPA emphasizes that this standard is only for cleanup sites involved in the active or passive ex situ treatment (or disposal) of CTC contaminated groundwater and wastewater from cleanup sites and that no other remedial actions at cleanup sites will be covered or affected. Additionally, while EPA considers solid wastes as part of the waste streams included in the disposal COU, at groundwater remediation sites managed by the Federal government and under existing waste disposal requirements, the WCPP requirements under this rulemaking only apply to water contaminated with CTC, and any other type of CTC-impacted waste will be managed according to relevant existing requirements under RCRA, other statutes, and regulatory agreements. Additionally, it is not necessary to establish previously proposed Subpart A definitions for “authorized person,” “owner or operator,” “potentially exposed person,” and “regulated area” in this final rule because EPA already established definitions for these terms at 40 CFR 751.5 in the TSCA section 6 final rule for methylene chloride (RIN 2070-AK70) (89 FR 39254, May 8, 2024 (FRL-8155-01-OCSPP)) so that these definitions may be commonly applied to this and other rules under TSCA section 6 that would be codified under 40 CFR part 751. Similarly, it is not necessary to establish previously proposed Subpart A definitions for “direct dermal contact,” “exposure group,” and “ECEL” in this final rule because EPA already established definitions for these terms at 40 CFR 751.5 in the TSCA section 6 final rule for PCE (RIN 2070-AK84). EPA proposed to require that the notification to companies to whom CTC is shipped under 40 CFR 751.111(c) identify the uses for which CTC is allowed to be distributed in commerce. To provide greater clarity to downstream users of CTC regarding the provisions of this rule, EPA is modifying the notification to identify the uses prohibited under this regulation. EPA also made other minor edits to the preamble and regulatory text to provide more clarity to the requirements of the final rule. IV. Provisions of the Final Rule EPA intends that each provision of this rulemaking be severable. In the event of litigation staying, remanding, or invalidating EPA's risk management approach for one or more conditions of use in this rule, EPA intends to preserve the risk management approaches in the rule for all other conditions of use to the fullest extent possible. The Agency evaluated the risk management options in TSCA section 6(a)(1) through (7) for each condition of use and generally EPA's regulation of one condition of use to address its contribution to the unreasonable risk from CTC functions independently from EPA's regulation of other conditions of use, which may have different characteristics leading to EPA's risk management decisions. Further, the Agency crafted this rule so that different risk management approaches are reflected in different provisions or elements of the rule that are capable of operating independently. Accordingly, the Agency has organized the rule so that if any provision or element of this rule is determined by judicial review or operation of law to be invalid, that partial invalidation will not render the remainder of this rule invalid. There are many permutations of the above. For example, as discussed in Unit IV.D., this final rule prohibits both the industrial and commercial use of CTC in metal recovery, and the industrial and commercial use of CTC as a processing aid in the manufacture of petrochemical-derived products except in the manufacture of vinyl chloride (for which EPA is requiring a WCPP as described in Unit III.A.). To the extent that a court were to find that EPA lacked substantial evidence to support the prohibition of CTC as a processing aid in the manufacture of petrochemical-derived products or otherwise found legal issues with EPA's approach to that condition of use, it would have no bearing on other similarly situated conditions of use, such as the industrial and commercial use in metal recovery, unless the specific issue also applies to the particular facts associated with metal recovery. This is reflected in the structure of the rule, which describes the prohibited conditions of use separately under 40 CFR 751.705. As another example, for the processing of CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE and the industrial and commercial use of CTC as a laboratory chemical, EPA took different risk management approaches—application of the WCPP for the processing of CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE and specific prescriptive controls for use as a laboratory chemical. To the extent that a court were to find a legal issue with EPA's approach to the WCPP, impacting the processing of CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE, it would have no bearing on EPA's decision to require specific prescriptive controls for industrial and commercial use as a laboratory chemical, and vice versa. This is reflected in the structure of the rule, which organizes the WCPP and prescriptive controls into different sections of the regulation. EPA also intends all TSCA section 6(a) risk management requirements in this rule to be severable from each regulatory exclusion from those requirements. For example, to the extent a court were to find a legal issue with excluding trace quantities of CTC from the rule's requirements pursuant to 40 CFR 751.701(b), or with excluding manufacture of CTC as a byproduct from WCPP requirements pursuant to 40 CFR 751.707(a)(1), the underlying risk management requirements would not be impacted. Rather, the excluded activities would become subject to the underlying TSCA section 6(a) risk management requirements applicable to the condition of use. EPA further notes that the specific examples of severability described in this unit are not intended to be exhaustive, but rather illustrative of a wide variety of scenarios that reflect EPA's overarching intent that each provision of this rulemaking be severable. EPA acknowledges that after the issuance of this rule, a person or entity may become aware of important information which indicates a particular use, that would otherwise be prohibited, is ongoing, and could meet the criteria of a WCPP. EPA also notes that there are multiple avenues to ask EPA to revisit issues in this TSCA section 6(a) rulemaking, both before and after the mandatory compliance dates are set consistent with TSCA section 6(d). EPA has the authority under TSCA section 6(g) to consider whether an exemption is appropriate and, consistent with TSCA section 6(g)(1), may propose such exemptions independently from this rulemaking. Additionally, any person could petition EPA to request that EPA issue or amend a rule under TSCA section 6. A. Applicability This final rule sets prohibitions and restrictions on the manufacture (including import), processing, distribution in commerce, commercial use, and disposal of CTC to prevent unreasonable risk of injury to health in accordance with TSCA section 6(a), 15 U.S.C. 2605(a). Additionally, pursuant to TSCA section 12(a)(2), this rule applies to CTC even if being manufactured, processed, or distributed in commerce solely for export from the United States because EPA has determined that CTC presents an unreasonable risk to health within the United States. Several commenters expressed concern that an unclear statement in the proposed rule preamble appeared to indicate that all manufacture, processing, and distribution for export would be prohibited under the proposed rule (Refs. 29, 30, 32). This was not EPA's intent. Rather, EPA intended to indicate that because EPA determined that CTC presents an unreasonable risk of injury to health within the United States, manufacturing and processing of CTC for export would not be exempt from any otherwise-applicable TSCA section 6(a) regulatory requirements. Because distribution in commerce did not contribute to EPA's unreasonable risk determination for CTC, and because this final rule permits manufacturing and processing, including recycling, for various uses to continue under the WCPP, EPA intends this final rule to permit manufacturing and processing in compliance with the WCPP for export, as well as distribution in commerce for export, without regard for the intended use in the destination country. In other words, manufacturing, processing, and distribution for the conditions of use listed in 40 CFR 751.705(a)(1)(i) and (ii) are prohibited where such conditions of use would occur inside the United States, but in instances where such conditions of use would occur solely outside of the United States after export, the upstream manufacturing, processing, and distribution for export would not be prohibited. EPA has clarified the regulatory text at 40 CFR 751.707(a) to make clear that any manufacture and processing for export must be in accordance with the WCPP. In addition, any persons who export or intend to export a chemical substance that is the subject of this final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D. EPA is revising the description of the Disposal COU to clarify the requirements of the WCPP at cleanup sites which would apply to any potentially exposed person involved in the disposal of CTC-containing groundwater to industrial treatment, industrial pre-treatment, or POTWs. A potentially exposed person most likely includes a worker who is involved with the activity of removing CTC-containing groundwater from the location where it was found and the on-site treatment of the groundwater, typically referred to as ex situ remediation, which is most consistent with the scope of the 2020 CTC Risk Evaluation. Ex situ remediation includes both active and passive remediation methods that span traditional ( e.g., pump and treat) and less traditional ( e.g., phytoremediation) approaches, but only if the remediation method would be considered industrial wastewater pretreatment, industrial wastewater treatment or discharge to a publicly owned treatment work (POTW). As discussed in Unit III.D, the prohibitions and restrictions described in this unit do not apply to CTC that is solely present unintentionally in trace quantities with another chemical substance or mixture, whether as a manufacturing residue, unreacted feedstock, byproduct, or other contaminant. Additionally, the provisions of this final rule only apply to chemical substances as defined under TSCA section 3. Notably, TSCA section 3(2) excludes from the definition of chemical substance “any food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device” and “any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq. ]) when manufactured, processed, or distributed in commerce for use as a pesticide.” Additional details regarding TSCA statutory authorities can be found in section 2 of the response to comments document (Ref. 11). EPA uses the term “potentially exposed person” in Unit IV. And in the regulatory text to include workers, occupational non-users, employees, independent contractors, employers, and all other persons in the work area where CTC is present and who may be exposed to CTC under the conditions of use for which a WCPP or specific prescriptive controls would apply. (EPA notes that this definition is intended to apply to occupational workspaces as part of implementation of the WCPP and other restrictions, and recognizes that other individuals or communities may be exposed to CTC as members of fenceline communities or members of the general population.) For certain conditions of use, EPA requires a comprehensive WCPP or specific prescriptive controls to address the unreasonable risk from CTC to workers directly handling the chemical or in the area where the chemical is being used. Similarly, the 2020 Risk Evaluation for Carbon Tetrachloride (Ref. 1) did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of CTC. For this reason, EPA uses the term “owner or operator” to describe the entity responsible for implementing the WCPP or specified prescriptive contr [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2024-29517. Public record. Not legal advice.