# Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-30117 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** December 18, 2024 - **Citation:** 89 FR 103560 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 751 [EPA-HQ-OPPT-2020-0720; FRL-8329-01-OCSPP] RIN 2070-AK84 Perchloroethylene (PCE); 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 perchloroethylene (PCE) 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, among other things, prevent serious illness associated with uncontrolled exposures to the chemical by preventing consumer access to the chemical, restricting the industrial and commercial use of the chemical while also allowing for a reasonable transition period where the industrial and commercial use of the chemical is being prohibited, providing a time-limited exemption for a critical or essential use of PCE for which no technically and economically feasible safer alternative is available, and protecting workers from the unreasonable risk of PCE while on the job. 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-2020-0720, 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: Kelly Summers, Existing Chemicals Risk Management Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-2201; email address: pce.tsca@epa.gov. For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620-1103; 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 You may be affected by this rule if you manufacture, process, distribute in commerce, use, or dispose of PCE or products containing PCE. TSCA section 3(9) defines the term “manufacture” to mean “to import into the 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 PCE are subject to provisions regulating manufacture of PCE. 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 might apply to them. Potentially affected entities include: • Crude Petroleum Extraction (NAICS code 211120). • Support Activities for Oil and Gas Operations (NAICS code 213112). • Nonwoven Fabric Mills (NAICS code 313230). • Wood Window and Door Manufacturing (NAICS code 321911). • Paper Bag and Coated and Treated Paper Manufacturing (NAICS code 322220). • Commercial Screen Printing (NAICS code 323113). • Petroleum Refineries (NAICS code 324110). • Petroleum Lubricating Oil and Grease Manufacturing (NAICS code 324191). • Petrochemical Manufacturing (NAICS code 325110). • Industrial Gas Manufacturing (NAICS code 325120). • Other Basic Inorganic Chemical Manufacturing (NAICS code 325180). • All Other Basic Organic Chemical Manufacturing (NAICS code 325199). • Plastics Material and Resin Manufacturing (NAICS code 325211). • Synthetic Rubber Manufacturing (NAICS code 325212). • Paint and Coating Manufacturing (NAICS code 325510). • Adhesive Manufacturing (NAICS code 325520). • Soap and Other Detergent Manufacturing (NAICS code 325611). • Polish and Other Sanitation Good Manufacturing (NAICS code 325612). • All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998). • Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing (NAICS code 326113). • All Other Plastics Product Manufacturing (NAICS code 326199). • Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220). • Rubber Product Manufacturing for Mechanical Use (NAICS code 326291). • All Other Rubber Product Manufacturing (NAICS code 326299). • Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS code 327110). • Glass Container Manufacturing (NAICS code 327213). • Cement Manufacturing (NAICS code 327310). • Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and Aluminum) (NAICS code 331492). • Metal Crown, Closure, and Other Metal Stamping (except Automotive) (NAICS code 332119). • Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing (NAICS code 332215). • Saw Blade and Handtool Manufacturing (NAICS code 332216). • Other Fabricated Wire Product Manufacturing (NAICS code 332618). • Metal Heat Treating (NAICS code 332811). • Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers (NAICS code 332812). • Electroplating, Plating, Polishing, Anodizing, and Coloring (NAICS code 332813). • Industrial Valve Manufacturing (NAICS code 332911). • Fluid Power Valve and Hose Fitting Manufacturing (NAICS code 332912). • Plumbing Fixture Fitting and Trim Manufacturing (NAICS code 332913). • Other Metal Valve and Pipe Fitting Manufacturing (NAICS code 332919). • Ball and Roller Bearing Manufacturing (NAICS code 332991). • Small Arms Ammunition Manufacturing (NAICS code 332992). • Ammunition (except Small Arms) Manufacturing (NAICS code 332993). • Small Arms, Ordnance, and Ordnance Accessories Manufacturing (NAICS code 332994). • Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code 332996). • All Other Miscellaneous Fabricated Metal Product Manufacturing (NAICS code 332999). • Other Industrial Machinery Manufacturing (NAICS code 333249). • Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS code 333415). • Machine Tool Manufacturing (NAICS code 333517). • Measuring, Dispensing, and Other Pumping Equipment Manufacturing (NAICS code 333914). • Welding and Soldering Equipment Manufacturing (NAICS code 333992). • Packaging Machinery Manufacturing (NAICS code 333993). • Industrial Process Furnace and Oven Manufacturing (NAICS code 333994). • Fluid Power Cylinder and Actuator Manufacturing (NAICS code 333995). • Fluid Power Pump and Motor Manufacturing (NAICS code 333996). • All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS code 333999). • Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS code 334513). • Analytical Laboratory Instrument Manufacturing (NAICS code 334516). • Motor Vehicle Body Manufacturing (NAICS code 336211). • Travel Trailer and Camper Manufacturing (NAICS code 336214). • Other Motor Vehicle Parts Manufacturing (NAICS code 336390). • Aircraft Manufacturing (NAICS code 336411). • Aircraft Engine and Engine Parts Manufacturing (NAICS code 336412). • Other Aircraft Parts and Auxiliary Equipment Manufacturing (NAICS code 336413). • Guided Missile and Space Vehicle Manufacturing (NAICS code 336414). • Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing (NAICS code 336415). • Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS code 336419). • Ship Building and Repairing (NAICS code 336611). • Surgical and Medical Instrument Manufacturing (NAICS code 339112). • Jewelry and Silverware Manufacturing (NAICS code 339910). • Sporting and Athletic Goods Manufacturing (NAICS code 339920). • Doll, Toy, and Game Manufacturing (NAICS code 339930). • Office Supplies (except Paper) Manufacturing (NAICS code 339940). • Gasket, Packing, and Sealing Device Manufacturing (NAICS code 339991). • Musical Instrument Manufacturing (NAICS code 339992). • Fastener, Button, Needle, and Pin Manufacturing (NAICS code 339993). • Broom, Brush, and Mop Manufacturing (NAICS code 339994). • Burial Casket Manufacturing (NAICS code 339995). • All Other Miscellaneous Manufacturing (NAICS code 339999). • Motor Vehicle Supplies and New Parts Merchant Wholesalers (NAICS code 423120). • Home Furnishing Merchant Wholesalers (NAICS code 423220). • Industrial Supplies Merchant Wholesalers (NAICS code 423840). • Service Establishment Equipment and Supplies Merchant Wholesalers (NAICS code 423850). • Other Miscellaneous Durable Goods Merchant Wholesalers (NAICS code 423990). • Grain and Field Bean Merchant Wholesalers (NAICS code 424510). • Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690). • Petroleum Bulk Stations and Terminals (NAICS code 424710). • Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) (NAICS code 424720). • New Car Dealers (NAICS code 441110). • Used Car Dealers (NAICS code 441120). • Other Gasoline Stations (NAICS code 447190). • Sporting Goods Stores (NAICS code 451110). • All Other Miscellaneous Store Retailers (except Tobacco Stores) (NAICS code 453998). • Scheduled Passenger Air Transportation (NAICS code 481111). • Scheduled Freight Air Transportation (NAICS code 481112). • Pipeline Transportation of Natural Gas (NAICS code 486210). • Teleproduction and Other Postproduction Services (NAICS code 512191). • Other Motion Picture and Video Industries (NAICS code 512199). • Miscellaneous Intermediation (NAICS code 523910). • Other Financial Vehicles (NAICS code 525990). • Lessors of Other Real Estate Property (NAICS code 531190). • Offices of Real Estate Agents and Brokers (NAICS code 531210). • Testing Laboratories (NAICS code 541380). • Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (NAICS code 541715). • Marketing Research and Public Opinion Polling (NAICS code 541910). • All Other Professional, Scientific, and Technical Services (NAICS code 541990). • Offices of Other Holding Companies (NAICS code 551112). • Hazardous Waste Treatment and Disposal (NAICS code 562211). • Solid Waste Landfill (NAICS code 562212). • Solid Waste Combustors and Incinerators (NAICS code 562213). • Other Nonhazardous Waste Treatment and Disposal (NAICS code 562219). • Remediation Services (NAICS code 562910). • Materials Recovery Facilities (NAICS code 562920). • All Other Miscellaneous Waste Management Services (NAICS code 562998). • General Automotive Repair (NAICS code 811111). • Automotive Exhaust System Repair (NAICS code 811112). • Automotive Transmission Repair (NAICS code 811113). • Other Automotive Mechanical and Electrical Repair and Maintenance (NAICS code 811118). • Automotive Body, Paint, and Interior Repair and Maintenance (NAICS code 811121). • Automotive Glass Replacement Shops (NAICS code 811122). • Automotive Oil Change and Lubrication Shops (NAICS code 811191). • All Other Automotive Repair and Maintenance (NAICS code 811198). • Consumer Electronics Repair and Maintenance (NAICS code 811211). • Computer and Office Machine Repair and Maintenance (NAICS code 811212). • Communication Equipment Repair and Maintenance (NAICS code 811213). • Other Electronic and Precision Equipment Repair and Maintenance (NAICS code 811219). • Commercial and Industrial Machinery and Equipment (except Automotive and Electronic) Repair and Maintenance (NAICS code 811310). • Home and Garden Equipment Repair and Maintenance (NAICS code 811411). • Other Personal and Household Goods Repair and Maintenance (NAICS code 811490). • Drycleaning and Laundry Services (except Coin-Operated) (NAICS code 812320). • Industrial Launderers (NAICS code 812332). 2. Applicability to Importers and Exporters. This action may also affect certain entities subject to import certification and export notification requirements 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 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(i)). Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA (see 19 CFR 12.121). 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. Any person who exports or intends to export PCE 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 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 PCE 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 PCE by EPA, under the conditions of use (Refs. 1 and 2). A description of the conditions of use that contribute to EPA's determination that PCE presents an unreasonable risk is in Unit III.B.1. of the 2023 PCE proposed rule, with a summary in Unit II.C.4. of this final rule. Accordingly, to address the unreasonable risk, EPA is finalizing a rule under TSCA section 6(a) to: (i) Prohibit most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce of PCE for those uses, outlined in Unit IV.D.1.; (ii) Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use, outlined in Unit IV.D.2.; (iii) Prohibit the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout, outlined in Unit IV.D.3.; (iv) Require a Workplace Chemical Protection Program (WCPP), including an inhalation exposure concentration limit, direct dermal contact controls, and related workplace exposure controls, for many occupational conditions of use of PCE not prohibited, outlined in Unit IV.B.; (v) Require prescriptive workplace controls for use of PCE in laboratories and energized electrical cleaners, outlined in Unit IV.C.; (vi) Establish recordkeeping and downstream notification requirements, outlined in Unit IV.E.; (vii) Provide a 10-year time limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of National Aeronautics and Space Administration's (NASA) mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available, outlined in Unit IV.F.; and (viii) Identify a regulatory threshold for products containing PCE for the prohibitions and restrictions on PCE, as outlined in Unit IV.A. EPA notes that all TSCA conditions of use of PCE 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. In addition, EPA is amending the general provision of 40 CFR part 751, subpart A, to define “Designated representative,” “Direct dermal contact,” “ECEL,” and “Exposure group” 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. 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.” PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020 (2020 Risk Evaluation for PCE) (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in December 2022 (Ref. 2), determining that PCE, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. On June 16, 2023, EPA issued a proposed rule (88 FR 39652) (FRL-8329-02-OCSPP)) under TSCA section 6(a) to regulate PCE, so that it no longer presents unreasonable risk (hereinafter “2023 PCE proposed rule”). The Agency received public comment on the proposal. With this action, EPA is finalizing with modifications the 2023 PCE proposed rule as described in this final rule. The conditions of use that contribute to the unreasonable risk from PCE are described in Unit III.B.1. of the 2023 PCE proposed rule. PCE's hazards are well established. EPA's 2020 Risk Evaluation for PCE considered the hazards associated with exposure to PCE and determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE. While some of the risks of adverse effects from PCE exposure are associated with acute single exposures, other risks are associated with long-term repeated exposures. The most sensitive health effect driving the unreasonable risk of PCE and selected as the basis for this rule is neurotoxicity from chronic exposure. It was selected based on the best available science and weight of scientific evidence and in consideration of the severity of the hazards, magnitude of exposure, population exposed, and uncertainties in the December 2020 Risk Evaluation for PCE and December 2022 revised risk determination for PCE. For PCE, impaired visual and cognitive function and diminished color discrimination following chronic exposures represent the most sensitive endpoint indicating neurotoxicity, based on epidemiological data reported in two studies that identified lowest observed adverse effect levels for color confusion and impaired pattern recognition and reaction time in pattern memory. Other significant adverse outcomes include kidney and liver effects, immune system toxicity, reproductive toxicity, developmental toxicity, and cancer. For this action, EPA has determined that protecting against the most sensitive endpoint would also address the risk for other acute, chronic non-cancer, and cancer endpoints. This final rule will eliminate the unreasonable risk to human health from the TSCA conditions of use of PCE, as identified in the 2020 Risk Evaluation for PCE and the revised unreasonable risk determination for PCE in December 2022. Although EPA is prohibiting many conditions of use of the chemical where it cannot be used without continuing to present unreasonable risk as described in Unit IV., EPA is not finalizing a complete ban on PCE. The Agency has considered the benefits of PCE for various uses as required under TSCA section 6(c)(2)(A) and (B) and recognizes that continued use of PCE for some TSCA conditions of use may provide benefits that complement the Agency's efforts to address climate-damaging hydrofluorocarbons (HFCs) under the American Innovation and Manufacturing Act of 2020 (AIM Act) (42 U.S.C. 7675), supporting human health and environmental protection under these programs, and that for these uses, strict workplace controls to address the unreasonable risk can be implemented. Therefore, this final rule allows PCE's continued use in tandem with strict workplace controls for the generation of HFC-125 and HFC-134a, two of the regulated substances that are subject to a 15-year phasedown under the AIM Act. HFCs-134a and -125 can be mixed with other substances to make lower global warming potential blends that are likely to be used to facilitate the transition away from HFC blends with higher global warming potentials in certain applications. Additionally, the Agency recognizes that some conditions of use may be important for national security applications or for other critical needs. For example, PCE is a critical diluent (to modify the consistency or other properties in a formulation) for maskant applied to military and commercial aircraft skin panels that prevents chemical milling or industrial etching of certain areas. It is also used in petrochemical manufacturing as a processing aid in catalyst regeneration for reformate and isomerate (these are gasoline blending stocks) that make up an estimated 45% of the United States gasoline pool. Therefore, this final rule allows certain continued uses of PCE provided that sufficient worker protections are in place to address the unreasonable risk for certain occupational conditions of use. For the conditions of use for which EPA is finalizing workplace controls under a WCPP, EPA expects that many workplaces already have stringent controls in place that reduce exposures to PCE; for some workplaces, EPA understands that these existing controls may already reduce exposures enough to meet the inhalation exposure concentration limit (called the existing chemical exposure limit (ECEL)) in this rulemaking or to prevent direct dermal contact with PCE. For many of the conditions of use for which EPA is finalizing workplace controls under a WCPP, data to support the industry's position 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 Small Business Advocacy Review (SBAR) Panel process, the comment period following publication of the 2023 PCE proposed rule, or stakeholder outreach, and are available in the corresponding public dockets (Docket ID Nos. EPA-HQ-OPPT-2020-0720; EPA-HQ-OPPT-2019-0502; EPA-HQ-OPPT-2016-0732). Accordingly, EPA is finalizing workplace controls to address the unreasonable risk and allow continued manufacture (including import), processing for conditions of use that are not prohibited, repackaging, recycling, and disposal of PCE as well as continued use of PCE for processing as a reactant/intermediate, certain uses in vapor degreasing and cold cleaning, use as a maskant for chemical milling, use in adhesives and sealants, use as a processing aid, use as energized electrical cleaner, and use as a laboratory chemical, which comprise more than an estimated 80% of the current production volume of PCE. EPA is finalizing a prohibition or phaseout for most conditions of use of PCE, including use in dry cleaning and spot cleaning, general aerosol degreasing, paints and coatings, aerosol lubricants, and wipe cleaning, comprising less than an estimated 20% of the current production volume of PCE. Of the conditions of use that are not prohibited, EPA generally expects the production volume for those conditions of use to decline over time. For example, EPA expects the industrial and commercial use of PCE as a reactant in the generation of HFC-134a and HFC-125 to decline over time, in light of the AIM Act requirements to phase down production and consumption of listed HFCs by 85% over the next 15 years. 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 of the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket (Ref. 3). As described in more detail in the Economic Analysis (Ref. 3) and in Units V.D. and VIII.C., EPA was unable to quantify all incremental costs of this final rule. The quantifiable cost of the final rule is estimated to be $43.43 million annualized over 20 years at a 2% discount rate. These costs take compliance with implementation of a WCPP into consideration, which would include meeting an ECEL of 0.14 ppm (0.98 mg/m 3 ) for inhalation exposures as an 8-hour time-weighted average (TWA), dermal controls to prevent direct dermal contact, applicable personal protective equipment (PPE) requirements, and reformulation costs of numerous products. The Economic Analysis notes various unquantified costs and uncertainty in the cost estimates (Sec. 7.14). The condition of use with the most expensive and uncertain compliance costs is the commercial use of PCE in energized electrical cleaning, which EPA estimates would result in about $20 million out of $43 million of estimated compliance costs. These estimates are based on assumptions regarding how much PCE is used for energized electrical cleaning and the types of locations of that use. Almost all of these compliance cost estimates are from respirator requirements for the use of PCE in energized electrical cleaning in confined spaces, which would require expensive respirators. Because there is no consensus industry estimate for what fraction of PCE use in energized electrical cleaning is in confined spaces, as described in Unit III.A.2.e., EPA estimated 5% of energized electrical cleaning use of PCE was in confined spaces. In addition, EPA estimates that 6,000 dry cleaners still use PCE, a majority of which are small businesses. Overall, EPA expects few closures because EPA estimates that only about 60 PCE machines are expected to be in use at the end of the phaseout period given the age of the machines and the declining trend of use; this is detailed in section 7.7 of the Economic Analysis. Table 7-11 in that section details the age of the PCE dry cleaning machines in New York State, for which EPA has data. EPA believes that the data are generalizable to other states; industry has informed the Agency that very few PCE machines have been purchased in recent years. See sections 7.7 and 11 of the Economic Analysis for additional detail on EPA's analysis, including uncertainties associated with estimating the economic impact. In alignment with the goals of President Biden's Cancer Moonshot, the rule will protect people from cancer and other adverse health effects of PCE by prohibiting most uses of PCE while ensuring essential uses can safely continue (Ref. 4). The actions in this final rule are expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. The monetized benefits of this rule are approximately $32.6 million to $84.6 million annualized over 20 years at a 2% discount rate. The monetized benefits include potential reductions in risk of liver, kidney, brain, and testicular cancer. Non-monetized benefits include risk reduction of neurotoxicity, kidney toxicity, liver effects, immune/hematological effects, reproductive effects, and developmental effects (Ref. 3). Neurotoxic effects associated with PCE exposure in human studies include visual deficits, impaired cognition, and neurodevelopmental outcomes from prenatal and early childhood exposure to PCE such as increased affinity of engaging in drug, alcohol, and tobacco use as a teen or adult (Ref. 1). Reductions in PCE exposure therefore may also be associated with additional important, but currently unmonetized, benefits. Additionally, the Agency expects that the dry cleaning phaseout will decrease significant adverse health risks for affected populations that may own, operate, or work at dry cleaning facilities, as well as children of workers present at dry cleaners. As described in more detail in the Economic Analysis, the Agency analyzed the demographic characteristics of several populations that would be impacted by this rulemaking, including for dry cleaning (Ref. 3). For the public's understanding, this document notes that based on reasonably available information, a significant number of members of minority populations may own or work at dry cleaning facilities. II. Background A. Overview of Perchloroethylene (PCE) As described in more detail in the 2023 PCE proposed rule, PCE is a neurotoxicant and considered “likely to be carcinogenic in humans”. This final rule applies to PCE (CASRN 127-18-4) and is specifically intended to address the unreasonable risk of injury to health EPA has identified in the 2020 Risk Evaluation for PCE and the 2022 revised unreasonable risk determination, as described in Unit II.C. PCE is a colorless volatile liquid with a mildly sweet odor that is produced in and imported into the United States. PCE is manufactured, processed, distributed, used, and disposed of as part of many industrial, commercial, and consumer conditions of use. As outlined in Unit II.C.4., PCE is used for the production of fluorinated compounds, as a solvent for dry cleaning and vapor degreasing; in catalyst regeneration in petrochemical manufacturing; and in a variety of commercial and consumer applications such as adhesives, paints and coatings, aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish and wipe cleaners. According to data submitted for the EPA's 2016 Chemical Data Reporting rule (CDR), the total aggregate annual production volume of PCE in the United States decreased from 388 million pounds to around 324 million pounds between 2012 and 2015 (Ref. 5). The total aggregate annual production volume ranged from 250 to 500 million pounds between 2016 and 2019 according to CDR (Ref. 6). B. Regulatory Actions Pertaining to PCE Because of its adverse health effects, PCE 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 PCE, as well as other Federal, State, and international regulations, is in the docket (Refs. 1, 7). As described in more detail in Unit II.C. of 2023 PCE proposed rule, and the Response to Public Comments document (Ref. 8), EPA considered the adequacy of the current occupational safety and health standards from the Occupational Safety and Health Administration (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 revised unreasonable risk determination are discussed further in the 2022 Revised Unreasonable Risk Determination for PCE, published in the Federal Register of December 14, 2022 (87 FR 76481 (FRL-9942-02-OCSPP)). 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 identified under TSCA. 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 PCE EPA published the scope of the PCE 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 May 2020, EPA published a draft risk evaluation (85 FR 26464, May 4, 2020 (FRL-10008-63)), and, after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk Evaluation for PCE in December 2020 in accordance with TSCA section 6(b) (85 FR 82474, December 18, 2020 (FRL-10017-44)). EPA subsequently issued a draft revised TSCA unreasonable risk determination for PCE (87 FR 39085, June 30, 2022 (FRL-9942-01-OCSPP)), and after public notice and receipt of comments, published a Revised Risk Determination for PCE in December 2022 (87 FR 76481, December 14, 2022 (FRL-9942-01-OCSPP)). The 2020 Risk Evaluation for PCE and supplemental materials are in Docket ID No. EPA-HQ-OPPT-2019-0502, and the December 2022 revised unreasonable risk determination and additional materials supporting the risk evaluation process in Docket ID No. EPA-HQ-OPPT-2016-0732. 1. 2020 Risk Evaluation In the 2020 Risk Evaluation for PCE, EPA evaluated risks associated with 61 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal (Ref. 1). Descriptions of these conditions of use are in Unit III.B.1. of the 2023 PCE proposed rule. The 2020 Risk Evaluation for PCE identified significant adverse health effects associated with short- and long-term exposure to PCE. A further discussion of the hazards of PCE is in Unit III.B.2. of the 2023 PCE proposed rule. 2. 2022 Revised Unreasonable Risk Determination As described in more detail in the 2023 PCE proposed rule, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for PCE and issued a final revised unreasonable risk determination in December 2022 (Ref. 2). EPA revised the risk determination for the 2020 Risk Evaluation for PCE 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. 9, 10, and 11). The revisions consisted of making the risk determination based on 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. 2), 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 PPE (Ref. 2). EPA determined that PCE 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 PCE. The PCE 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. 2) and also in Unit III.B.1. of the 2023 PCE 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. 3. Description of Unreasonable Risk EPA has determined that PCE presents an unreasonable risk of injury to health under the conditions of use, based on acute and chronic non-cancer risks and chronic cancer risks. As described in more detail in the 2023 PCE proposed rule and as described in the TSCA section 6(b) 2020 Risk Evaluation for PCE, EPA identified non-cancer effects from both acute and chronic inhalation and dermal exposures to PCE, and cancer from chronic inhalation and dermal exposures to PCE (Ref. 1). EPA identified neurotoxicity as the most robust and sensitive endpoint for non-cancer adverse effects from acute inhalation and dermal exposures and as the most robust and sensitive endpoint for non-cancer adverse effects from chronic inhalation and dermal exposures for all conditions of use (Ref. 1). Other adverse effects associated with exposure to PCE include kidney and liver effects, immune system toxicity, and developmental toxicity. By targeting the sensitive chronic neurotoxicity effects endpoint for risk management, EPA's final rule will also prevent the unreasonable risks from acute, chronic non-cancer and cancer endpoints associated with inhalation and dermal exposure to PCE. 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 PCE (Ref. 1) and were considered in the determination of unreasonable risk for PCE. 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). Condition of use descriptions for PCE are provided in Unit III.B.1. of the 2023 PCE proposed rule and were obtained from EPA sources such as CDR codes, the 2020 Risk Evaluation for PCE 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 and in Unit III.D. (Ref. 8). 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 in the 2023 PCE proposed rule, for the purposes of this final rule, “occupational conditions of use” refers to the TSCA conditions of use described in Units III.B.1.a., b., c., and e. of the 2023 PCE proposed rule. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for PCE (Ref. 1) for purposes of distinguishing 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. Additionally, as described in the 2023 PCE proposed rule, in the 2020 Risk Evaluation for PCE (Ref. 1), EPA identified and assessed all known, intended, and reasonably foreseen industrial, commercial, and consumer uses of PCE. EPA determined that all industrial, commercial, and consumer uses of PCE evaluated in the 2020 Risk Evaluation for PCE contribute to the unreasonable risk of injury to health. As such, for purposes of this risk management rule, “consumer use” refers to all known, intended, or reasonably foreseen PCE consumer uses. Likewise, for the purpose of this risk management rule, “industrial and commercial use” refers to all known, intended, or reasonably foreseen PCE 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 PCE 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 non-risk factors, including an unreasonable risk to a 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 section 6(a) requirements to the extent necessary so that the chemical substance no longer presents such risk. The TSCA section 6(a) requirements can include one or more of the following actions alone in or 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 (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 (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 (section 6(a)(2)). • Require clear and adequate minimum warning 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 (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 (section 6(a)(4)). • Prohibit or otherwise regulate any manner or method of commercial use of the substance or mixture (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 (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 (section 6(a)(7)). In the 2023 PCE proposed rule under TSCA section 6(a), EPA analyzed how the TSCA section 6(a) requirements could be applied to address the unreasonable risk from PCE so that it no longer presents such risk. Unit II.D.1. of this final rule summarizes the TSCA section 6 considerations for issuing regulations under TSCA section 6(a). Unit V. of the 2023 PCE proposed rule outlines how EPA applied these considerations specifically to managing the unreasonable risk from PCE. As required, EPA developed a proposed regulatory action and alternative regulatory actions, which are described in Units IV.A. and IV.B., respectively, of the 2023 PCE proposed rule. 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. EPA also considered how it could exercise its authority under TSCA to regulate the manufacturing (including import), processing, and/or distribution in commerce of PCE at different levels in the supply chain to eliminate exposures or restrict the availability of PCE and PCE-containing products for consumer use in order 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 2023 PCE proposed rule. EPA's considerations regarding TSCA section 6(c)(2)(A) for PCE are discussed in full in Unit VI. of the 2023 PCE proposed rule, including the statement of effects with respect to these considerations. After review of 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 the 2023 PCE proposed rule, EPA considered the availability of alternatives when finalizing a prohibition or a substantial restriction (TSCA section 6(c)(2)(C)) (Ref. 12), and in setting final compliance dates in accordance with the requirements in TSCA section 6(d)(1). To the extent information was reasonably available, EPA considered pollution prevention strategies and the hierarchy of controls adopted by OSHA and the National Institute for Occupational Safety and Health (NIOSH) when developing its 2023 PCE 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 took into account the information presented in the 2020 Risk Evaluation for PCE (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 actions described in Unit II.D.3. Additional details related to how the requirements described in this Unit II.D.1. were incorporated into development of the 2023 PCE proposed rule and alternative actions are in Unit V. of the 2023 PCE proposed rule. 2. Consultations and Other Engagement a. Consultations EPA conducted consultations and outreach as part of the development of the 2023 PCE proposed rule. The Agency held a federalism consultation from July 22, 2021, to October 22, 2021, as part of the rulemaking process and pursuant to Executive Order 13132 (Ref. 13). EPA also consulted with Tribal officials during the development of the 2023 PCE proposed rule (Ref. 14). The Agency held a Tribal consultation from May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8, 2021 (Ref. 14). EPA received no written comments as part of this consultation. EPA's Environmental Justice (EJ) consultation occurred from June 3, 2021, to August 20, 2021. On June 16, 2021, and July 6, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to Executive Orders 12898 and 14008. EPA received five written comments following the EJ meetings, in addition to oral comments provided during the consultation (Refs. 15, 16, 17, 18, 19). The 2023 PCE proposed rule presents a brief summary of the comments in Unit III.A.1. of the 2023 PCE proposed rule. As required by section 609(b) of the Regulatory Flexibility Act (RFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives (SERs) that potentially would be subject to the rule's requirements. EPA met with SERs before and during Panel proceedings, on September 26, 2022, and November 10, 2022. Panel recommendations were addressed in Unit X.C. of the 2023 PCE proposed rule and in the Initial Regulatory Flexibility Analysis (IRFA) (Ref. 20); the Panel report is in the docket (Ref. 21). EPA has also prepared a Final Regulatory Flexibility Analysis (FRFA) (Ref. 22). The Agency presents more information regarding the consultations in Units X.C., X.E., X.F., and X.J. of the 2023 PCE proposed rule. b. Other Stakeholder Consultations For development of the 2023 PCE proposed rule, in addition to the formal consultations described in Unit X. of the 2023 PCE proposed rule, EPA held a webinar on January 14, 2021, providing an overview of the TSCA risk management process and the risk evaluation findings for PCE (Ref. 23). EPA also presented on the TSCA risk management process and the findings in the 2020 Risk Evaluation for PCE (Ref. 24) at a Small Business Administration (SBA) Office of Advocacy Environmental Roundtable on January 15, 2021. Attendees of these meetings were given an opportunity to voice their concerns regarding the risk evaluation and risk management. Furthermore, during development of the 2023 PCE proposed rule, EPA engaged in discussions with representatives from different industries, non-governmental organizations, organized labor, technical experts, and users of PCE. A list of external meetings held during the development of the 2023 PCE proposed rule is available in the docket (Ref. 25); meeting materials and summaries are also available in the docket. A summary of the topics discussed during these meetings is in Unit III.A.2. of the 2023 PCE proposed rule. c. Children's Environmental Health The Agency's 2021 Policy on Children's Health (Ref. 26) 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 PCE no longer presents an unreasonable risk (which includes unreasonable risk to any relevant potentially exposed or susceptible subpopulations). Information on how the 2021 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 2023 PCE proposed rule, the 2020 Risk Evaluation for PCE (Ref. 1), and the Economic Analysis (Ref. 3). 3. Proposed Regulatory Action EPA's 2023 PCE proposed rule under TSCA section 6(a) to address the unreasonable risk presented by PCE under its conditions of use included the following: • Prohibition of most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce, of PCE for those uses; • Prohibition of the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; • Prohibition of the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout; • Requirements for strict workplace controls, including a PCE WCPP, which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact with PCE, for the 16 occupational conditions of use not prohibited; • Requirements for prescriptive workplace controls for laboratory use; • Establishments of recordkeeping and downstream notification requirements; and • A 10-year time-limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of NASA's mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available. EPA notes that all TSCA conditions of use of PCE were subject to the 2023 PCE proposed rule and are subject to this final rule. The 2023 PCE proposed rule included proposed timeframes for implementation. The prohibitions EPA proposed for most conditions of use would take effect in phases, beginning at the top of the supply chain, and coming into full effect after 24 months, as described in Units IV.A.1.a. and IV.A.1.b. of the 2023 PCE proposed rule. The phaseout period for dry cleaning that EPA proposed would take full effect after 10 years, as described in Unit IV.A.1.c. of the 2023 PCE proposed 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.2. of the 2023 PCE proposed rule. EPA also proposed a compliance timeframe of 12 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. These were included in the 2023 PCE proposed rule in Unit IV.B. Similar to the proposed regulatory action, both the primary and second alternative regulatory actions combined prohibitions, requirements for a WCPP, and prescriptive controls to address the unreasonable risk from PCE under its conditions of use. The primary alternative regulatory action combined prohibitions, a WCPP, and prescriptive controls to address the unreasonable risk from PCE driven by its conditions of use. At the time of publication of the 2023 PCE proposed rule, uncertainties regarding the feasibility of implementing workplace safety control measures in open systems or when worker activities require manual application or removal of PCE or PCE-containing products, availability of alternatives, or whether the use is ongoing or phased out for most of these conditions of use led EPA to propose prohibition. At the time of proposal, EPA did not have reasonably available information to confidently conclude that these conditions of use could meet requirements of a WCPP. The alternative regulatory action also considered and included WCPP for laboratory use to seek input on requiring the non-prescriptive WCPP instead of the prescriptive workplace controls included in the proposed regulatory action. The primary alternative regulatory action also considered prescriptive workplace controls where existing engineering controls, administrative controls, and PPE may already address the unreasonable risk for some conditions of use that would be subject to a WCPP under the proposed regulatory action. Additionally, the primary alternative regulatory action included requirements for a concentration limit for PCE in industrial and commercial use in solvent-based adhesives and sealants. The primary alternative regulatory action also included longer timeframes for prohibitions and implementation of WCPP and prescriptive controls. Those timeframes were described in Unit IV.B. of the 2023 PCE proposed rule. The second alternative regulatory action combined prohibitions, requirements for a WCPP, prescriptive controls, and two time-limited exemptions to address the unreasonable risk from PCE driven by its conditions of use. This second alternative regulatory action included prohibitions on some conditions of use that would have requirements for a WCPP under the proposed regulatory action. The second alternative regulatory action also included shorter compliance timeframes for prohibition and a WCPP. Additionally, this second alternative regulatory action did not include staggered prohibition compliance dates for manufacturers, processors, and distributors. The secondary alternative regulatory action compliance timeframes are described in Unit IV.B. of the 2023 PCE proposed rule. For a comprehensive overview of the alternative regulatory actions, refer to Unit IV.B. of the 2023 PCE proposed rule, with the rationale for the alternative regulatory actions provided in Unit V.A.2. of the 2023 PCE proposed rule. 4. Public Comments Received EPA requested comment on all aspects of the 2023 PCE proposed rule, and during the public comment period, EPA held a webinar on July 19, 2023, providing an overview of the 2023 PCE proposed rule and TSCA section 6; during the webinar, members of the public had the opportunity to share their perspectives (Ref. 27). The comment period closed on August 15, 2023. EPA received 749 public comments, with a majority received from individuals participating in mass mailer campaigns organized by non-governmental organizations. The public comments also include approximately 89 unique comments from industry stakeholders, trade associations, environmental groups, unions, academic institutions, a State government agency, a Federal Government agency, and members of the regulated community. A summary of the comments as well as EPA's responses is in the docket for this rulemaking (Ref. 8). 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 2023 PCE proposed rule, EPA held meetings with stakeholders to receive clarifying information on their comments, including affected industry and interested groups, related to the use of PCE. 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 (Docket ID No. EPA-HQ-OPPT-2020-0720) (Ref. 28). After review of the public comments received on the 2023 PCE 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. 8). 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 Based on Public Comment Unit III. summarizes the main changes from the 2023 PCE proposed rule to this final rule, based on the consideration of the public comments. A. Changes to the Risk Management Approach for Certain Conditions of Use As described in Units III.A.1. and 2., when compared to the 2023 PCE proposed rule, EPA's final rule prohibits two additional conditions of use (Unit III.A.1.), allows three additional conditions of use under the WCPP (Units III.A.2.a. through c.), broadens the types of prescriptive controls required for one condition of use (Unit III.A.2.d.), and allows one additional condition of use to continue under specific prescriptive controls or the WCPP (Unit III.A.2.e.). 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 PCE for the conditions of use allowed to continue, and that these changes do not significantly impact the production volume of PCE expected to remain in commerce when compared to the proposed regulatory action. Taken together, the conditions of use described in Unit III.A.1. and 2. account for less than an estimated 5% of the total production volume of PCE. 1. Additional Conditions of Use Subject to Prohibition: Industrial and Commercial Uses of PCE as a Solvent for In-Line Vapor Degreasing EPA is finalizing a prohibition for the industrial and commercial use of PCE as a solvent for in-line conveyorized vapor degreasing and for in-line web cleaner vapor degreasing, which were considered for prohibition in the second alternative regulatory action of the 2023 PCE proposed rule. As described in section 6 of the Economic Analysis for the 2023 PCE proposed rule (Ref. 29), EPA estimated that approximately two conveyorized vapor degreasers and no web vapor degreasers use PCE. One public commenter, a critical cleaning consultant, stated they no longer encounter in-line conveyorized or in-line web vapor degreasers using PCE (Ref. 30). Additionally, commenters identified alternative types of degreaser technologies, such as open-top batch vapor degreasers, closed-loop batch vapor degreasers, and airless batch vapor degreasers, that clean effectively and for which monitoring data and detailed process descriptions of PCE activities for these types of degreasers confirm that compliance with an ECEL of 0.14 ppm as an 8-hr TWA is possible (Refs. 30, 31). As described in Unit V.A.1. of the 2023 PCE proposed rule, prohibition is the preferred risk management option for occupational conditions of use where reasonably available information suggest minimal ongoing use or when feasible safer alternatives are reasonably available. Based on information provided by commenters and other information reasonably available to the Agency indicating that the use of PCE in in-line conveyorized and in-line web vapor degreasing is no longer ongoing, and availability of technologically feasible alternative vapor degreasing technology, EPA has determined that the unreasonable risk from PCE when used in both types of in-line vapor degreasers is best addressed with a prohibition. 2. Additional Conditions of Use Subject to Restrictions: WCPP and Prescriptive Controls a. Processing PCE Into Formulation, Mixture, or Reaction Product in Other Chemical Products and Preparations EPA is finalizing a WCPP for processing PCE into formulation, mixture, or reaction product in other chemical products and preparations, as included in the primary alternative regulatory action of EPA's proposal (88 FR 39652, June 16, 2023)(FRL-8329-02-OCSPP)). While EPA proposed to prohibit processing PCE into formulation, mixture or reaction product in other chemical products and preparations, this was because EPA proposed to prohibit the downstream industrial, commercial, and consumer uses associated with other chemical products and preparations. EPA included this condition of use under the WCPP in the primary alternative regulatory action. EPA received several comments regarding processing PCE into formulation, mixture, or reaction product. One commenter stated that there appeared to be a disconnect between the proposed prohibitions on processing PCE versus prohibitions on distribution and/or use of PCE and requested that EPA clarify the prohibitions throughout all steps in the supply chain for each particular condition of use (Ref. 32). For example, the commenter stated that EPA proposed that PCE may be processed into a formulation, mixture, or reaction product in paint and coating mixtures but also proposed to prohibit the manufacturing, processing, distribution in commerce, and use of PCE in solvent-based paints and coatings. The commenter also stated that EPA proposed that PCE could be used for industrial and commercial use in maskants for chemical milling but did not explicitly permit the manufacturing or processing of PCE for use in maskants. Another commenter expressed opposition to EPA's proposed prohibition on processing of PCE for other chemical products and preparations, and stated that the proposed prohibition appeared to be based on an overly broad assumption that exposures to PCE in this condition of use correspond to aerosol packing (Ref. 33). In Unit III.B.1.b.iv. of the 2023 PCE proposed rule, EPA described how the condition of use of processing PCE into formulation, mixture, or reaction products in paint and coating products refers to when PCE is added to a paint or coating product for further distribution, including when PCE is incorporated into coating products such as maskant (88 FR 39652, June 16, 2023)(FRL-8329-02-OCSPP)). However, to avoid confusion regarding which processing into formulation, mixture, or reaction product condition of use of PCE is associated with each downstream industrial and commercial condition of use of PCE, and, in particular, confusion regarding which products may fall under the category of “other chemical products and preparations,” EPA is finalizing WCPP for all PCE processing into formulation, mixture, or reaction products, including in other chemical products and preparations, to make clear that all processing of PCE into formulation, mixture, or reaction product conditions of use, including in cleaning and degreasing products, in adhesive and sealant products, and in paint and coating products that are not prohibited by virtue of the downstream use being prohibited, are subject to the WCPP. As in the 2023 PCE proposed rule, all manufacturing, processing, and distribution in commerce of PCE for any downstream industrial, commercial, or consumer condition of use that is prohibited under the final rule would also be prohibited. In response to a comment requesting clarity regarding prohibitions throughout all steps of the value chain for each condition of use, EPA clarifies that the final rule includes prohibitions (staggered by lifecycle stage) for the manufacture, processing, distribution in commerce, and for all consumer, industrial and commercial use of PCE and PCE-containing products, except for those industrial and commercial uses which will continue under the WCPP or prescriptive controls, or are otherwise not prohibited. Therefore, in this final rule, WCPP applies to processing PCE for uses that are not prohibited. b. Industrial and Commercial Use of PCE as a Processing Aid EPA is finalizing a WCPP for industrial and commercial use of PCE as a processing aid in pesticide, fertilizer, and other agricultural manufacturing, as included in the primary alternative regulatory action of the 2023 PCE proposal rule. While EPA proposed to prohibit the industrial and commercial use of PCE as a processing aid in pesticide, fertilizer, and other agricultural manufacturing, this was due to insufficient information at the time of proposal to determine that compliance with the WCPP would be possible. For example, at the time of proposal, EPA was not aware of any monitoring data or detailed description of PCE activities for this use to confirm that compliance with an ECEL of 0.14 ppm as an 8-hr TWA would be possible. EPA requested comment on the ability of facilities in this sector to successfully implement the WCPP for this particular use because of the industrial nature of the use. EPA received a few comments regarding the industrial and commercial use as a processing aid in pesticide, fertilizer, and other agricultural manufacturing. Two commenters disagreed with EPA's proposal to prohibit PCE use as a processing aid in the manufacture of agricultural chemicals and stated that it is unclear what information EPA relied on to conclude that this use could not meet the WCPP requirements (Refs. 33, 34). One commenter stated that this use of PCE is critical to the manufacture of certain agricultural products and described how they limit PCE exposure and manage production risks through strong product stewardship and industrial hygiene practices. Following a meeting to receive clarifying information on their comment, one commenter submitted information on worker activities and safety measures in place that provide worker protection for this use (Ref. 35). As described in the submitted information, activities associated with potential exposure to PCE include transfer, sample, and maintenance, where control measures such as purging lines/vessels prior to opening, closed sampling box, and PPE reduce exposures. Based on the information received, EPA believes such control measures that indicate the ability to comply with the WCPP requirements may be implementable for all those using PCE as a processing aid in pesticide, fertilizer, and other agricultural chemical manufacturing. Additionally, information submitted to EPA indicates that PCE may be used as a processing aid in industrial sectors other than petrochemical manufacturing and pesticide, fertilizer, and other agricultural chemical manufacturing (Refs. 33, 36). The 2020 Risk Evaluation assessed occupational exposures for “processing aids, specific to petroleum production—catalyst regeneration in petrochemical manufacturing” and “processing aids, not otherwise listed—pesticide, fertilizer and other agricultural chemical manufacturing” under the industrial processing aid Occupational Exposure Scenario (Ref. 1). While other specific processing aid uses of PCE were not identified in the 2020 Risk Evaluation, EPA expects the exposure assessment, including the worker activities, to be consistent across all processing aid type uses. For example, as assessed in the risk evaluation, worker activities that may result in exposure for use as a processing aid include unloading PCE into process equipment and maintenance. Similar to control measures that reduce the potential for exposure and indicate the ability to comply with the WCPP for use as a processing aid in the pesticide, fertilizer, and other agricultural chemical manufacturing sector, EPA has determined that control measures such as use occuring in a highly specialized closed system with minimal exposure to PCE during infrequent worker activity limit the potential for exposure and indicate the ability to comply with the WCPP for use as a processing aid in other industrial sectors. Therefore, EPA believes the WCPP requirements are practicable and implementable for all processing aid uses which occur at sophisticated industrial sites. EPA's determination is based on reasonably available information included in submissions to EPA related to process descriptions, worker activities, and exposure mitigation practices for use of PCE as an industrial processing aid in sectors other than petrochemical manufacturing and pesticide, fertilizer, and agricultural chemical manufacturing (Refs. 1, 36). The information submitted to EPA as part of the comment period regarding the industrial and commercial use of PCE as a processing aid in sectors other than petrochemical manufacturing (including industrial and commercial use as a processing aid in pesticide, fertilizer and agricultural chemical manufacturing) and supported by subsequent discussions, demonstrated the users' ability to comply with the WCPP. For this reason, EPA has determined that the unreasonable risk from PCE when used as a processing aid, even in sectors other than petrochemical manufacturing and pesticide, fertilizer, and agricultural chemical manufacturing, could be addressed with a WCPP. Therefore, in this final rule, EPA is finalizing a WCPP for all industrial and commercial use of PCE as a processing aid in sectors other than petrochemical manufacturing and a WCPP for industrial and commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing. c. Industrial and Commercial Use of PCE as Solvent for Cold Cleaning of Tanker Vessels EPA is finalizing a WCPP for industrial and commercial use of PCE as solvent for cold cleaning of tanker vessels, which is a sub-use of the industrial and commercial use of PCE as solvent for cold cleaning, which EPA proposed to prohibit in the proposal (88 FR 39652, June 16, 2023) (FRL-8329-02-OCSPP)). While EPA proposed to prohibit industrial and commercial use of PCE as solvent for cold cleaning, this was due to insufficient information at the time of proposal to determine that compliance with the WCPP would be possible and EPA believed alternatives were reasonably available. EPA requested comment on whether to consider a regulatory alternative that would subject more conditions of use of PCE to a WCPP, instead of a prohibition, than those contemplated in the primary alternative regulatory action. EPA also requested monitoring data and detailed descriptions of PCE-involving activities for these conditions of use to determine whether these additional conditions of use could comply with the WCPP such that risks are no longer unreasonable. EPA received one comment regarding the industrial and commercial use of PCE in cold cleaning of tanker vessels. The commenter requested that EPA not prohibit this use because entities utilize PCE and other solvents, such as methylene chloride, ortho-dichlorobenzene, monochlorobenzene, and toluene, to clean tanks safely and effectively, when water and detergents are not compatible with the cargo material (Ref. 37). The commenter suggested that EPA establish the WCPP to maintain this use. Following a September 26, 2023, meeting with an industry user to receive clarifying information on their comment, the commenter submitted information on worker activities and safety measures in place that provide worker protection for this use (Ref. 38). As described in the submitted information, tank cleaning with a solvent is typically infrequent (about every two years) and worker exposure occurs during sampling and connecting or disconnecting of hoses to or from the ship manifold or waste truck, activities during which control measures are in place. Based on the information submitted regarding this condition of use, and supported by subsequent discussions, EPA believes such controls and safety measures may be implementable industry wide. EPA received two comments regarding industrial and commercial use of PCE in cold cleaning generally. One commenter stated that the empirical and modeled exposure data for cold cleaning in the risk evaluation are very similar to that for degreasing, but EPA proposed to allow continued use of PCE under the WCPP in vapor degreasing and not cold cleaning (Ref. 33). Another commenter associated with the aerospace and defense sector urged EPA to permit ongoing use under the WCPP for PCE as a cold, immersion cleaner (Ref. 32). However, for all cold cleaning other than cold cleaning of tanker vessels, EPA does not have any reasonably available information, including monitoring or detailed process description, that supports the ability to comply with a WCPP such that the risks are no longer unreasonable. EPA does not have any reasonably available information that indicates the exposure frequency, worker activities, and safety measures associated with cold cleaning of tanker vessels, as described by the commenter, are applicable to other cold cleaning operations, which may vary in equipment design or worker activities (Ref. 37, 38). The information submitted to EPA during the comment period regarding the industrial and commercial use of PCE as a solvent for cold cleaning of tanker vessels, supported by subsequent discussions, demonstrated the users' ability to comply with the WCPP. For this reason, EPA has determined that the unreasonable risk from PCE when used in cold cleaning of tanker vessels could be addressed with a WCPP. EPA is finalizing a prohibition for all other cold cleaning applications of PCE. d. Industrial and Commercial Use of PCE as a Laboratory Chemical In general, EPA is finalizing the prescriptive control requirements for the industrial and commercial use of PCE as a laboratory chemical as proposed, with some modifications, based on consideration of public comments. As described in the 2023 PCE proposed rule, to address the unreasonable risk of injury to health resulting from dermal exposures to PCE 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 PCE in a laboratory setting for each potentially exposed person in direct dermal contact with PCE. 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 12 months of publication of the final rule. Under the primary alternative regulatory action, EPA included the WCPP for laboratory use of PCE and solicited comment on non-prescriptive requirements to meet an ECEL and Direct Dermal Contact Control (DDCC) as compared to the prescriptive workplace controls of using a fume hood and dermal PPE. EPA received several comments regarding the industrial and commercial use of PCE as a laboratory chemical. Several commenters 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 (Refs. 39, 40, 41). The commenters urged EPA to more closely align its requirements for laboratory use of PCE with OSHA's laboratory standard to reduce the compliance burden. Some commenters expressed support for the use of fume hoods and other engineering controls over the WCPP and suggested that EPA include flexibility for engineering controls beyond a fume hood for consistency with the OSHA laboratory standard (Refs. 40, 42). The commenters stated that while fume hoods are considered best practice and are commonly used to reduce exposure in laboratories, some experiment designs utilizing PCE may not be able to be accommodated within a fume hood. Commenters described other alternative controls that can be designed and implemented to reduce exposure, such as glove boxes, exhausted enclosures, air-free solvent purification systems, and fume extractors. One commenter described other laboratory standards, including the American National Standards Institute (ANSI)/American Society of Safety Professionals (ASSP) Z9.5 Laboratory Ventilation standard and the ANSI/American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) 62.1 Ventilation and Acceptable Indoor Air Quality standard, that laboratories adhere to in addition to OSHA's laboratory standard that they state meet or exceed the worker protections under EPA's proposed WCPP and prescriptive controls (Refs. 41, 43, 44). 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.1. of the 2023 PCE proposed rule, EPA proposed to require fume hoods in laboratory settings to codify assumptions made in the 2020 Risk Evaluation for PCE, where EPA's risk estimates and determination that inhalation exposures from the industrial and commercial use of PCE as a laboratory chemical did not contribute to the unreasonable risk were predicated on its findings that expected safety practices of using PCE in small amounts under a fume hood reduce the potential for inhalation exposures. For the industrial and commercial use of PCE 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 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 PCE is used in a laboratory setting aligns with existing requirements from 29 CFR 1910.1450(e)(3)(iii). As detailed in Unit IV.C. of this final rule, EPA is finalizing as proposed the requirements for dermal PPE in combination with comprehensive training for tasks related to the use of PCE in a laboratory setting. 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 PCE identified for the industrial and commercial use as a laboratory chemical. e. Industrial and Commercial Use of PCE as Energized Electrical Cleaner EPA is finalizing requirements to comply with either specific prescriptive controls or the WCPP for the industrial and commercial use of PCE as energized electrical cleaner, which is a sub-use of the industrial and commercial use of PCE as solvent for aerosol spray degreaser/cleaner, as described in Unit III.B.1.c.vi. of the 2023 PCE proposed rule. In the proposal, EPA proposed to prohibit the industrial and commercial use of PCE as solvent for aerosol spray degreaser/cleaner because the Agency was not able to identify reasonably available information such as monitoring data or detailed activity descriptions to indicate with certainty that relevant regulated entities could mitigate the identified unreasonable risk through a WCPP. EPA considered requiring a WCPP for this condition of use under the primary alternative regulatory action because of uncertainties regarding the availability of alternatives for all aerosol spray degreasing/cleaning applications, including for energized electrical cleaning. EPA requested comment on the ways PCE may be used, including the likelihood of successful compliance with the WCPP for this condition of use. EPA also requested comment on prescribing specific engineering or administrative controls that would reduce inhalation and dermal exposures enough to address the unreasonable risk across all workplaces engaged in a condition of use. Additionally, EPA requested comment on whether to include a self-certification requirement for purchasing PCE or PCE-containing products. EPA received several comments expressing concern over the proposed prohibition on energized electrical cleaning (Refs. 45, 46, 33, 47, 48, 49). Several commenters stated that safer alternatives are not available because alternative products not containing PCE likely present a flammability safety issue (Refs. 45, 48, 47, 50). A commenter also stated that some cleaning in the electrical utility industry is conducted underground in confined spaces where respiratory protection is used and a non-flammable product, such as those containing PCE, is needed to control a potential fire hazard (Ref. 45). In addition to describing the need for PCE in energized electrical cleaning, commenters described the work practices and context that support the potential for exposure reduction to PCE through workplace controls, rather than prohibition. As an example, one commenter described work practices and controls for energized electrical cleaning, stating that facilities that require cleaning of energized equipment rely on skilled technicians or other professional users who typically have education and training that may include two years at lineman school, time as an apprentice, licensing or certifications, and continuing education (Ref. 45). Additionally, the commenter stated that OSHA General Industry and Construction standards include requirements specific to electrical work under 29 CFR part 1926, subparts E, K, and V. Commenters also described State-level regulations that exclude energized electrical cleaners from prohibitions on the manufacture and sale of PCE-containing general purpose degreasing products, electrical cleaners, and electronic cleaners (Refs. 45, 49). Another commenter stated that EPA should not prohibit energized electrical cleaning because petroleum refineries safely use energized electrical cleaners on a regular basis (Ref. 48). While many commenters advocated for continued use of PCE for this condition of use, they differed in whether the WCPP or other workplace controls would be most suitable. Some commenters stated that the WCPP would be impractical for energized electrical cleaning because trained technicians often travel to different facilities to conduct work, including facilities that may not otherwise use PCE, and suggested that instead of a WCPP, a training and certification program would be sufficient to address the unreasonable risk (Refs. 45). Other commenters suggested PCE use for cleaning of energized electrical equipment should be exempt from the rule under a TSCA section 6(g) exemption (Refs. 45, 46, 33, 47). Based on the information submitted to EPA as part of the comment period regarding this condition of use, supported by subsequent discussions, and in consideration of existing best practices and regulations for work in electrical spaces as well as the lack of reasonably available technically and economically feasible alternatives to PCE that also do not present a potential flammability concern for energized electrical cleaning, EPA has determined that the unreasonable risk from PCE when used as energized electrical cleaner could be addressed with a combination of labeling, self-certification, and either the WCPP or specific prescriptive controls, including dermal PPE and respiratory protection. EPA notes the importance of existing OSHA regulations designed to protect workers exposed to dangers such as electric shock, electrocution, fires, and explosions. Specifically, in addition to the requirements for electrical work under OSHA General Industry and Construction standards at 29 CFR part 1926, subparts E, K, and V that one commenter mentioned in their public comment, OSHA regulates electrical work under Occupational Safety and Health standards at 29 CFR part 1910. For example, OSHA requires safety-related work practices on electrical equipment under the Electrical Standard at 29 CFR part 1910, subpart S (29 CFR 1910.301 to 1910.399), which was significantly updated in 2007. OSHA also sets forth requirements for the operation and maintenance of electrical power generation, control, transformation, transmission, and distribution lines and equipment under the Electric Power Generation, Transmission, and Distribution Standard at 29 CFR part 1910, subpart R (29 CFR 1910.269), last amended in 2015. Additionally, OSHA regulates electrical protective equipment under the Electrical Protective Equipment Standard at 29 CFR part 1910, subpart I (29 CFR 1910.137), which was significantly updated in 2014. Other standards and best practices apply to electrical safety in the workplace, for example the National Fire Protection Association 70E Standard for Electrical Safety in the Workplace (Ref. 51). Under the Electrical Standard at 29 CFR 1910.333 and the Electric Power Generation, Transmission, and Distribution Standard at 29 CFR 1910.269, OSHA requires employers to establish minimum approach distances from exposed energized parts, depending on the voltage, that persons must maintain unless they are a qualified employee that meets certain requirements under 29 CFR 1910.269(l)(3)(iii)(A) through (C) or 29 CFR 1910.333(c)(3)(ii)(A) through (C). In instances where persons need to clean or degrease energized equipment in an area that is not considered a confined space, as defined in 29 CFR 1910.146(b), or an enclosed space (such as a manhole or vault) as described in 29 CFR 1910.269(e), for example housekeeping overhead lines, but are not permitted to approach or take conductive objects closer to the exposed energized part than the employer's established minimum approach distance, persons may be able to use tools, such as a hotstick with an aerosol spray can holder adapter or other live-line tools to clean the energized equipment (Ref. 52). In such instances where persons are maintaining the established minimum approach distance while conducting energized electrical cleaning in an area that is not confined or enclosed, EPA believes the potential for inhalation exposures is minimal. As noted earlier, EPA has determined that the unreasonable risk from PCE when used as energized electrical cleaner could be addressed with a combination of labeling, self-certification, and either (i) specific prescriptive controls, including dermal PPE and respiratory protection, or (ii) the WCPP. EPA's finalized requirements for industrial and commercial use of PCE as energized electrical cleaner are described in Unit IV.C.2. Other industrial and commercial use as a solvent for aerosol spray degreasers/cleaners is prohibited in the final rule, consistent with the proposal for that condition of use. EPA's workplace requirements to address the unreasonable risk for PCE as an energized electrical cleaner are consistent to the extent possible with existing regulations and best practices for work in electrical spaces such as OSHA's Electrical Standard at 29 CFR part 1910, subpart S and the Electric Power Generation, Transmission, and Distribution Standard at 29 CFR part 1910, subpart R. In this final rule, EPA is also adding a definition of “energized electrical cleaner” to 40 CFR 751.603, consistent with the definition promulgated in States such as California ( Title 17, California Code of Regulations, Article 2, section 94508 ), New York ( 6 CRR-NY III A 235 ), Maine ( 06 ME Code Rules § 096-152 ), Rhode Island ( 250-RICR-120-05-31 ), Connecticut ( section 22a-174-40 ), Delaware ( 7 Del. Admin. Code § 1141-1.0 ), Washington, DC ( 20 DCMR, Chapter 7, section 718 ), Maryland ( COMAR 26.11.32 ), New Jersey ( New Jersey Administrative Code 5:23-6.1 ), Indiana ( Standards for Consumer and Commercial Products (CCP)—VOC Rule 326 IAC 8-15 ), Illinois ( Administrative Cod Title 35, § 223.265 ), and Massachusetts ( 310 CMR 7.25 ). B. Changes to Timeframes 1. Changes to the WCPP Timeframe For the conditions of use for which EPA proposed the WCPP, EPA proposed several compliance timeframes, including the following requirements: • Initial exposure monitoring must be conducted within six months of publication of the final rule or within 30 days of introduction of PCE into the workplace if PCE use commences at least six months after the date of publication; • Each owner or operator ensure that exposure to PCE does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons within nine months of publication of the final rule; and • Owners and operators implement an exposure control plan within 12 months of publication of the final rule. In the primary alternative regulatory action described in the 2023 PCE proposed rule, EPA described slightly longer timeframes that included the following: • Initial exposure monitoring be conducted within 12 months of publication of the final rule; • Each owner or operator ensures that the exposure to PCE does not exceed the ECEL as an 8-hour TWA for all potentially exposed persons within 15 months of publication of the final rule; and • Owners and operators implement an exposure control plan within 18 months of publication of the final rule. 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 for any procedural adjustments needed to comply with the establishment of a respiratory protection program and development of an exposure control plan. EPA further requested comment on any advantages or drawbacks associated with the longer timeframes outlined in the primary alternative regulatory action, and noted that the Agency may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. EPA also requested comment regarding issues around the viability of current analytical methods and detection limits for occupational PCE sampling and/or monitoring methods. Public comments highlighted challenges with the proposed timeframes and suggested longer timeframes for initial exposure monitoring. For example, some commenters stated that the proposed 6-month timeframe within which to conduct initial exposure monitoring may not be possible because PCE use may be infrequent and occur only periodically or annually, such as in maintenance exercises or in batch manufacturing operations (Refs. 53, 54, 32). One commenter expressed concern that requirements to comply with a new exposure limit would stress industrial hygiene consultants and laboratories that analyze the samples, and urged EPA to ensure that there would be adequate time for consultant firms and laboratories to establish sufficient capacity (Ref. 55). Some commenters described how entities need more time than what was proposed to assess exposures to various products and processes and noted that the complexity of the WCPP provisions would require taking multiple measurements for the presence of PCE in various operations across multiple facilities, which will be challenging to layer on top of the employer's OSHA compliance practices (Refs. 32, 47, 54). Other commenters stated the proposed 6-month timeframe for initial monitoring would be untenable and suggested that the deadline be extended to 12 months (Refs. 31, 33, 56, 49). Two commenters reasoned that at least 12 months would be necessary to revalidate methods and determine whether revision to corporate exposure assessment strategy would be necessary to address the new ECEL (Refs. 33, 49). Commenters stated that a corporate exposure assessment strategy or similar mechanism would necessitate the procurement of professional services, adding logistical demand for these specialized services. The commenters also noted that monitoring at the proposed ECEL and action level would likely require laboratory analysis (rather than direct measurement) that will delay the availability of results and make meeting a 6-month timeframe challenging. 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 360 days, as provided in the primary alternative regulatory action described in the proposal, is as soon as practicable to conduct initial monitoring for PCE, which likely would require regulated entities to contract new services or realign current industrial hygiene professionals towards WCPP compliance. Adopting this timeframe from the primary alternative approach (providing 360 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, the requirements for each owner or operator to ensure that exposures to PCE do not exceed the ECEL as an 8-hour TWA for all potentially exposed persons, including by providing respiratory protection, take effect 450 days after publication of the final rule. 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 2023 PCE 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. Additionally, for clarity in regulatory requirements and reduced burden in implementation, EPA is finalizing a compliance date for preventing direct dermal contact, including by use of dermal PPE, that is 450 days after publication of the final rule, so that this compliance timeframe is consistent with timeframe to ensure inhalation exposures do not exceed the ECEL. EPA believes that 450 days is as soon as practicable and provides a reasonable transition period for regulated entities to evaluate potential for direct dermal contact with PCE, establish a PPE program, acquire the appropriate dermal PPE, and conduct the required training. 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 (0.14 ppm (8-hr TWA)) that is significantly lower than the OSHA PEL of 100 ppm (8-hr TWA) and the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV) of 25 ppm (8-hr TWA) for PCE, some 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 two years to transition to the ECEL (Refs. 57, 54). 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 are the least burdensome and most effective for workers (Refs. 49, 33). Based on comments, outreach, reasonably available information, existing OSHA standards, and industry best practices, 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 PCE, EPA has determined that a longer compliance timeframe of 900 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 PCE. 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 360 days of the publication date for this final rule or within 30 days of introduction of PCE into the workplace, whichever is later; (2) The requirements for each owner or operator to ensure that exposure to PCE 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 450 days of the publication date for this final rule or within three months after receipt of the results of any exposure monitoring that indicates an exceedance of the ECEL; (3) The requirements that each owner or operator ensure all persons are separated, distanced, physically removed, or isolated from direct dermal contact with PCE, including by providing dermal PPE, must be met within 450 days of the publication date of this final rule; and (4) The requirements for development and implementation of an exposure control plan must be met within 900 days of the publication date of this final rule. EPA is also finalizing as proposed, with a 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 450 days of the publication date of this final rule (see Unit IV.B.7.a.). However, EPA understands that 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 Defense to continue to engage in vapor degreasing. 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, including 915 days for initial monitoring, 1,005 days to ensure that no person is exposed to an airborne concentration of PCE that exceeds the ECEL, and 1,095 days to implement an exposure control plan. 2. Changes to Prohibition Timeframes For most occupational conditions of use that EPA proposed to prohibit, EPA proposed that prohibitions would become effective in a staggered schedule for each stage of the supply chain and would come into effect after the publication of this final rule: In 12 months for manufacturers, 15 months for processors, 18 months for distributors to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users. For consumer uses, EPA proposed that the prohibitions of manufacturing, processing, and distribution in commerce of PCE for consumer use would take effect after the publication of this final rule: In 12 months for manufacturers, 15 months for processors, 18 months for distributing to retailers, and 21 months for all other distributors and retailers. EPA's primary alternative regulatory action, discussed in the 2023 PCE proposed rule, included slightly longer timeframes, which begin after the publication of this final rule: In 18 months for manufacturers, 21 months for processors, 24 months for distributing to retailers, 27 months for all other distributors (including retailers), and 30 months for industrial and commercial uses. EPA requested comment regarding the proposed and alternative compliance dates for prohibitions and whether additional time is needed. Several commenters raised concerns about the timeframe for complying with prohibitions from the proposed regulatory action, stating that EPA should consider longer timeframes for prohibition to avoid disruptions to the supply chain for continuing uses, help minimize disposal of products left on retail shelves, and provide sufficient time to identify, research, test, qualify, and implement cost-effective alternative substances or processes (Refs. 32, 50, 33). One commenter expressed concern that the proposed compliance timeframes would cause certain products containing PCE to leave the market, potentially cutting off PCE supply for continuing critical uses and creating a risk of obsolescence for essential equipment that is reliant on PCE. Some commenters expressed that there may be circumstances in which a chemical alternative is not an exact, drop-in replacement for certain conditions of use, or in which new, additional, or modifications to existing engineering equipment could be necessary (Refs. 33, 50, 45). These commenters further expressed concerns regarding coordination with suppliers or customers across the supply chain (including with certifying entities in circumstances where a formulation change may require recertifying a product to meet performance standards, for example) that may require a transitioning process. Due to these and other concerns, some commenters supported longer timeframes for prohibition than what was proposed, which would provide additional time that commenters described as necessary for seeking alternatives, successfully implementing their use, and mitigating supply chain impacts (Refs. 33, 50, 45). One commenter stated that the proposed 24-month prohibition is significantly shorter than for other EPA programs, such as EPA's National Emission Standards for Hazardous Air Pollutants (NESHAP) which typically provide 36 months for compliance, and suggested that EPA extend the deadlines to 12 months for manufacturing, 21 months for processing, 24 months for distribution to retailers, and 30 months for retail distribution (Ref. 50). Other commenters recommended that EPA double the proposed prohibition timeframes for manufacturers and processors, suggested longer timeframes, and suggested that EPA extend the sell-through period of products already in commerce by six months (Refs. 45, 46, 33). After reviewing all of the comments, in this final rule EPA is modifying the proposed prohibition compliance timeframes for most uses to lengthen them to the prohibition compliance timeframes included in the primary alternative regulatory action, which will allow for successful implementation of the prohibitions in a manner that is as soon as practicable while providing for a reasonable transition period. This extension will also provide additional time for regulated entities to consult with their upstream suppliers and downstream customers and to make necessary adjustments, thereby mitigating immediate concerns for operational continuity for conditions of use identified in Units IV.B. and C. The timeframes for prohibition EPA is finalizing are described in detail in Unit IV.D. EPA is finalizing as proposed the prohibition on the manufacturing, processing, distribution in commerce, and industrial and commercial use of PCE for dry cleaning and spot cleaning through a 10-year phaseout, as outlined in Unit IV.D.3. C. Changes to WCPP Requirements 1. Exposure Monitoring Requirements As part of the WCPP, EPA proposed to require owners or operators to meet certain documentation requirements for each monitoring event of PCE, 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 at 40 CFR part 792 (Refs. 46, 54, 53, 56, 48, 55, 49). Commenters stated that it is atypical, for industrial hygiene purposes, to use this standard for air sampling of PCE (Refs. 33, 55, 49). According to the commenters, it is common practice within the industrial hygiene community to have analyses performed by American Industrial Hygiene Association (AIHA) accredited laboratories (Ref. 49). Some commenters recommended that provisions of monitoring results and recordkeeping in the final rule be allowed from any accredited laboratory, without regard to a specific type, or allowing any number of approved monitoring methods, especially AIHA accredited laboratories (Refs. 56, 46). Commenters also suggested applying the policy described in typical TSCA section 5(e) orders that establish a New Chemical Exposure Limit under the TSCA New Chemicals Program, which state that compliance with TSCA 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. 33, 55, 49). Another commenter reasoned the 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. 53). EPA agrees with the commenter that the WCPP is incompletely served by solely relying on the GLP Standard initially put forth in the 2023 PCE proposed rule. 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. 33, 55, 49), 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. 58). 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 PCE without taking respiratory protections into account when being performed. This will ensure the highest degree of protection to potentially exposed persons by logging accurate ambient air concentrations of PCE, thus empowering owners or operators to appropriately consider the hierarchy of controls. As part of the WCPP, EPA also proposed to establish an ECEL action level of 0.07 ppm as an 8-hour TWA for PCE. As described in Unit IV.A.2.b. of the 2023 PCE proposed rule, air concentrations at or above the action level would trigger more frequent periodic monitoring of exposures to PCE, consistent with the action level approach utilized by OSHA in the implementation of OSHA standards, although the values differ due to differing statutory authorities. EPA proposed an action level that would be half the 8-hour ECEL, which is in alignment with the precedented approach established under most OSHA standards. EPA solicited comment regarding an ECEL action level that is half the ECEL and any associated provisions related to the ECEL action level when the ECEL is significantly lower than the OSHA PEL. EPA also requested comment on viability of current analytical methods and detection limits for PCE sampling. EPA received several comments regarding an action level that is half the ECEL and the viability of detecting to the action level with existing analytical methods. One commenter supported the establishment of an action level that is one-half the ECEL as this stratified approach will impose appropriate controls based on the particulars of each workplace (Ref. 58). Other commenters expressed concern regarding the proposed ECEL action level, stating that the action level should not be included in the regulation because of challenges to reliably measure to the proposed value and suggesting EPA consider best practice for industrial hygiene exposure assessment published by the AIHA (Refs. 33, 57). Commenters warned that implementing a monitoring methodology for the proposed ECEL would not be seamless because existing monitoring methods are not adequate. As an example, commenters stated that the NIOSH 1003 method, as currently validated, will not achieve the limit of detection required for evaluating to the proposed ECEL or action limit (Refs. 33, 49). Commenters stated that passive sampling methods cannot measure to below the ECEL, and thus entities would need to rely on active sampling with a pump with samples sent out to laboratories for analysis (Refs. 45, 47). Another commenter asserts that the proposed ECEL action level of 0.07 ppm is not detectable and stated that the best way to ensure reliable and comparable results is to use a digital measuring device, which can currently detect concentrations up to 10 ppm and are in development to detect concentrations as low as 0.1 ppm, which is the lowest on the global market (Ref. 59). Additionally, other commenters stated that NIOSH recommends a detection limit of 10% of the occupational exposure limit (Refs. 33, 49, 60). EPA acknowledges the challenges of occupational personal breathing zone monitoring to levels consistent with the ECEL action level and ECEL. As noted earlier, EPA intends for the WCPP to align with, to the extent possible, certain elements of the existing OSHA standards for regulating toxic and hazardous substances under 29 CFR part 1910, subpart Z and is therefore finalizing an action level different from the proposed 0.07 ppm ECEL action level to support a trigger for more frequent periodic monitoring. In consideration of public comment, reasonably available information, and outreach, EPA has determined that revising the ECEL action level to 0.10 ppm as an 8-hr TWA for PCE is appropriate given the limits of detection and limits of quantification for existing monitoring methods. EPA notes that while real-time monitoring with a digital measuring device is not required for rule compliance, EPA understands the practical benefits of real-time occupational exposure monitoring. EPA also notes that the reliable limits of quantification for available analytical methods ( e.g., NIOSH 1003 and OSHA 5000) are below the ECEL action level of 0.10 ppm. 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 if results indicated non-detect or air monitoring equipment malfunction, 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 the requirement is inconsistent with OSHA rules, is an unnecessary step that adds no value to reduce risk to workers, and could be costly, especially for smaller companies (Refs. 56, 32, 57, 33, 47, 48, 49). One commenter suggested that EPA incorporate a six-sample rolling average, as the statistical evaluation would incorporate ongoing validation of exposure levels for a particular task and thus remove any need for resampling based on a non-detect result. 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 2023 PCE 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 [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%3A2024-30117. Public record. Not legal advice.