Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA), 39652-39723 [2023-12495]

Download as PDF 39652 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 751 [EPA–HQ–OPPT–2020–0720; FRL–8329–02– OCSPP] RIN 2070–AK84 Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA) Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to address the unreasonable risk of injury to human health presented by perchloroethylene (PCE) under its conditions of use as documented in EPA’s December 2020 Risk Evaluation for PCE and December 2022 revised risk determination for PCE prepared under the Toxic Substances Control Act (TSCA). PCE is a widely used solvent in a variety of occupational and consumer applications including fluorinated compound production, petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. 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 the chemical no longer presents unreasonable risk. PCE, also known as perc and tetrachloroethylene, is a neurotoxicant and a likely human carcinogen. Neurotoxicity, in particular impaired visual and cognitive function and diminished color discrimination, are the most sensitive adverse effects driving the unreasonable risk of PCE, and other adverse effects associated with exposure include central nervous system depression, kidney and liver effects, immune system toxicity, developmental toxicity, and cancer. To address the identified unreasonable risk, EPA is proposing to prohibit most industrial and commercial uses of PCE; the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; the manufacture (including import), processing, and distribution in ddrumheller on DSK120RN23PROD with PROPOSALS3 SUMMARY: VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 commerce of PCE for all consumer use; and, the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 10-year phaseout. For certain conditions of use that would not be subject to a prohibition, EPA is also proposing to require a PCE workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. EPA is also proposing to require prescriptive workplace controls for laboratory use, and to establish recordkeeping and downstream notification requirements. Additionally, EPA proposes to provide certain time-limited exemptions from requirements for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available. Comments must be received on or before August 15, 2023. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 17, 2023. DATES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2020–0720, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets/. ADDRESSES: FOR FURTHER INFORMATION CONTACT: For technical information contact: Kelly Summers, Existing Chemicals Risk Management Division, 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 contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 I. Executive Summary A. Does this action apply to me? You may be potentially affected by the proposed action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of PCE or products containing 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 applies 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). E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules • 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). VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 • 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). PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 39653 • 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). E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39654 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules • 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). This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final TSCA section 6(a) rule are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 the export notification requirements in 40 CFR part 707, subpart D. If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT. B. What is the Agency’s authority for taking this action? Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S. Environmental Protection Agency hereinafter EPA or ‘‘the Agency,’’ determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. C. What action is the Agency taking? Pursuant to TSCA section 6(b), EPA determined that 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). The term ‘‘conditions of use’’ is defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A detailed description of the conditions of use that drive EPA’s determination that PCE presents an unreasonable risk is included in Unit III.B.1. EPA notes that all TSCA conditions of use of PCE are subject to this proposal. Accordingly, to address the unreasonable risk, EPA is proposing, 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.A.1.; (ii) Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use, outlined in Unit IV.A.1.; (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.A.1.; (iv) Require strict workplace controls, including a PCE Workplace Chemical Protection Program (WCPP), which PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 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, outlined in Unit IV.A.2.; (v) Require prescriptive workplace controls for laboratory use, outlined in Unit IV.A.3.; and (vi) Establish recordkeeping and downstream notification requirements, outlined in Unit IV.A.4. (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 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.A.5. In addition, EPA is proposing to amend the general provision of 40 CFR part 751, subpart A, to define ‘‘authorized person,’’ ‘‘direct dermal contact,’’ ‘‘ECEL,’’ ‘‘exposure group,’’ ‘‘owner or operator,’’ ‘‘potentially exposed person,’’ ‘‘regulated area,’’ and ‘‘retailer’’ 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. EPA seeks public comment on all aspects of this proposed rule. 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. As a result, EPA is proposing to take action to the extent necessary so that PCE no longer presents such risk. The unreasonable risk is described in Unit III.B.2. and the conditions of use that drive the unreasonable risk for PCE are described in Unit III.B.1. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules 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 proposed rule is neurotoxicity, 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. The most sensitive endpoint is dependent on both the point of departure (POD) and the associated total uncertainty factor. 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 proposed rulemaking, 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 proposed rule would 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. EPA is not proposing 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 VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 uses, strict workplace controls to address the unreasonable risk can be implemented. Therefore, this rule proposes to allow 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 phasedown under the AIM Act. While HFC–125 and HFC–134a are two of the regulated substances subject to the phasedown in production and consumption by 85% over the next 15 years, 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 from certain other HFCs and 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 and 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 U.S. gasoline pool. Therefore, this rule proposes to allow 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 proposing strict 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 proposed in this rulemaking or to prevent direct dermal contact with PCE. Accordingly, EPA is proposing strict workplace controls to address the unreasonable risk and allow continued use of PCE for several conditions of use, including for processing as a reactant/ intermediate, use in vapor degreasing, use as a maskant for chemical milling, use in adhesives and sealants, use as a processing aid in catalyst regeneration in petrochemical manufacturing, and use as a laboratory chemical, which comprise more than an estimated 80% of the current production volume of PCE. EPA is proposing to ban or phaseout most conditions of use of PCE, PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 39655 including use in dry cleaning and spot cleaning, 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 would not be prohibited, EPA 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. Unit IV.A. describes EPA’s proposed regulatory action and Unit IV.B. describes the alternative regulatory actions as required under TSCA section 6(c)(2)(A). The rationale for the proposed regulatory action and alternative regulatory actions, including the TSCA section 6 requirements considered in developing the regulatory actions, is described in Units III.B.3. and V. 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 VI.D. and X.D., EPA was unable to quantify all incremental costs of this proposed rule. The quantifiable cost of the proposed rule is estimated to be $14.0 million annualized over 20 years at a 3% discount rate and $14.3 million annualized over 20 years at a 7% discount rate. These costs take compliance with implementation of a WCPP into consideration, which would include an existing chemical exposure limit (ECEL) of 0.14 ppm (0.98 mg/m3) 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 most notable unquantified costs include possible costs from prohibition of use of PCE as a processing aid outside of the petrochemical industry; EPA’s analysis was unable to quantify these costs, as described more fully in section 7.11 in the Economic Analysis (Ref. 3). The economic impact on users of PCE for chemical milling and vapor degreasing is also unclear because there are no clear alternatives to PCE; these users might have to use PPE to meet the requirements of a WCPP for PCE. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39656 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules Chemical milling using PCE is most prominent in the aerospace industry. Vapor degreasing is used in several advanced manufacturing industries, including aerospace, automotive, energy, medical devices, and others (Ref. 3). In addition, EPA estimates that 6,000 dry cleaners still use PCE, a majority of which are small businesses. Nevertheless, despite information EPA has sought from stakeholders, it is still unclear as to the impact of a prohibition of PCE for dry cleaning through a gradual phaseout; EPA has not been able to estimate the number of dry cleaning facility closures that may be associated with this phaseout. More information on the challenges of estimating these impacts, in part due to the age of relevant machines in use, is in the Economic Analysis (Ref. 3). 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 proposed 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 7–10 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 is generalizable to other states; industry has informed the Agency that very few PCE machines have been purchased in recent years. Based on the estimated revenues per firm presented in Table 31 of the Economic Analysis and the 6,000 estimated number of dry cleaning firms using PCE as dry cleaning solvent (see section 6.1.5 (A) of the Economic Analysis), the total revenue for dry cleaning firms using PCE as dry cleaning solvent is approximately $3.1 billion. According to IRS (2013) data, profit in this sector is about 4.8% of sales, implying that total profit of firms using PCE as dry cleaning solvent is about $148 million. However, EPA has proposed a 10-year phaseout of PCE in dry cleaning and estimates that only about 60 PCE dry cleaning machines would remain at the end of the phaseout (see section 7.7.3. of the Economic Analysis). This suggests that the proposed option would only affect about $31 million of the industry’s total revenue and about $1.5 million of the industry’s profit. Many of these firms would likely choose to purchase nonPCE machines or become drop shops (do dry cleaning at another site) rather than close. A detailed sensitivity analysis of varying assumptions on ages of PCE dry cleaning machines and PCE dry cleaning machine life is provided in section 11 of the Economic Analysis. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 The actions proposed in this 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 proposed rule are approximately $10.2 million to $46.3 million annualized over 20 years at a 3% discount rate and $4.72 million to $29.4 million annualized over 20 years at a 7% 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 of PCE in human studies include visual deficits, impaired cognition, and decreased math scores. Also, prenatal and early childhood exposure to PCE in drinking water are associated with increases in drug, alcohol, and tobacco use (Ref. 1). Reductions in PCE exposure are therefore likely to be associated with large dollar-valued, but currently unmonetized, benefits. Additionally, the Agency expects that the proposed dry cleaning phaseout will decrease health risks for affected populations that may own/operate or work at dry cleaning facilities. 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). Based on reasonably available information, the Agency understands that a significant number of members of minority populations may own or work at dry cleaning facilities. II. Background A. Overview of Perchloroethylene This proposed 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 III.B.2. 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 further detail in Unit III.B.1., PCE is used for the production of fluorinated compounds, as a solvent for dry cleaning and vapor degreasing; PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 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 U.S. decreased from 388 million pounds to around 324 million pounds between 2012 and 2015 (Ref. 4). The total aggregate annual production volume ranged from 250 to 500 million pounds between 2016 and 2019 according to CDR (Ref. 5). 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 other Federal, state, and international regulations (Ref. 6) is in the docket and in Appendix A of the 2020 Risk Evaluation for PCE (Ref. 1). C. Consideration of Occupational Safety and Health Administration (OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA Risk Management Actions Although EPA must consider and factor in, to the extent practicable, certain nonrisk factors as part of TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still ensure that the selected regulatory requirements apply ‘‘to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk.’’ 15 U.S.C. 2605(a). This requirement to eliminate unreasonable risk is distinguishable from approaches mandated by some other laws, including the Occupational Safety and Health Act (OSH Act), which includes both significant risk and feasibility (technical and economic) considerations in the setting of standards. Congress intended for EPA to consider occupational risks from chemicals it evaluates under TSCA, among other potential exposures, as relevant and appropriate. As noted previously, TSCA section 6(b) requires EPA to evaluate risks to PESS identified as relevant by the Administrator. TSCA section 3(12) defines the term ‘‘potentially exposed or susceptible subpopulation’’ as ‘‘a group of individuals within the general population identified by the Administrator who, due to either greater E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.’’ The OSH Act similarly requires OSHA to evaluate risk specific to workers prior to promulgating new or revised standards and requires OSHA standards to substantially reduce significant risk to the extent feasible, even if workers are exposed over a full working lifetime. See 29 U.S.C. 655(b)(5); Indus. Union Dep’t, AFL–CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980) (plurality opinion). Thus, the standards for chemical hazards that OSHA promulgates under the OSH Act share a broadly similar purpose with the standards 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, as this section outlines, 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 (Ref. 6) when evaluating and addressing potential unreasonable risk to workers so that compliance requirements are clearly explained to the regulated community. ddrumheller on DSK120RN23PROD with PROPOSALS3 1. OSHA Requirements OSHA’s mission is to ensure that employees work in safe and healthful conditions. The OSH Act establishes requirements that each employer comply with the General Duty Clause of the Act (29 U.S.C. 654(a)), as well as with occupational safety and health standards issued under the Act. a. General Duty Clause of the OSH Act The General Duty Clause of the OSH Act requires employers to keep their workplaces free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. The General Duty Clause is cast in general terms, and does not establish specific requirements like exposure limits, PPE, or other specific protective measures that EPA could potentially consider when developing its risk evaluations or risk management requirements. OSHA, under limited circumstances, has cited the General Duty Clause for regulating exposure to chemicals. To prove a violation of the General Duty Clause, OSHA must prove employer or industry recognition of the hazard, that the hazard was causing or VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 likely to cause death or serious physical harm, and a feasible method to eliminate or materially reduce the hazard was available. In rare situations, OSHA has cited employers for violation of the General Duty Clause where exposures were below a chemicalspecific permissible exposure limit (PEL), a TWA based on an employee’s average airborne exposure in any 8-hour work shift of a 40-hour work week which shall not be exceeded (Ref. 7). In such situations, OSHA must demonstrate that the employer had actual knowledge that the PEL was inadequate to protect its employees from death or serious physical harm. Because of the heavy evidentiary burden on OSHA to establish violations of the General Duty Clause, it is not frequently used to cite employers for employee exposure to chemical hazards. b. OSHA Standards OSHA standards are issued pursuant to the OSH Act and are found in title 29 of the CFR. There are separate standards for general industry, laboratories, construction, maritime and agriculture sectors, and general standards applicable to a number of sectors (e.g., OSHA’s Respiratory Protection standard). OSHA has numerous standards that apply to employers who operate chemical manufacturing and processing facilities, as well as to downstream employers whose employees may be occupationally exposed to hazardous chemicals. OSHA sets legally enforceable limits on the airborne concentrations of hazardous chemicals, referred to as PELs, established for employers to protect their workers against the health effects of exposure to hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, OSHA was permitted an initial 2-year window after the passage of the Act to adopt ‘‘any national consensus standard and any established Federal standard.’’ 29 U.S.C. 655(a). OSHA used this authority in 1971 to establish PELs that were adopted from Federal health standards originally set by the Department of Labor through the Walsh-Healy Act, in which approximately 400 occupational exposure limits (OELs) were selected based on the American Conference of Governmental Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about 25 exposure limits recommended by the American Standards Association (now called the American National Standards Institute or ANSI) were adopted as PELs. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 39657 Following the 2-year window provided under section 6(a) of the OSH Act for adoption of national consensus and existing Federal standards, OSHA has issued health standards following the requirements in section 6(b) of the Act. OSHA has established approximately 30 PELs under section 6(b)(5) as part of comprehensive substance-specific standards that include additional requirements for protective measures such as use of PPE, establishment of regulated areas, exposure assessment, hygiene facilities, medical surveillance, and training. These ancillary provisions in substancespecific OSHA standards further mitigate residual risk that could be present due to exposure at the PEL. Many OSHA PELs have not been updated since they were established in 1971, including the PEL for PCE. In many instances, scientific evidence has accumulated suggesting that the current limits of many PELs are not sufficiently protective. On October 10, 2014, OSHA published a Federal Register document in which it recognized that many of its PELs are outdated and inadequate for ensuring protection of worker health (79 FR 61384). 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. As described in that notice, while new advancements or developments in science and technology from the time a PEL is promulgated may improve the scientific basis for making findings of significant risk, technical feasibility or economic feasibility, OSHA has been unable to update most of the PELs established in 1971 and they remain frozen at levels at which they were initially adopted (79 FR 61384, October 10, 2014). One example of how industries have evolved in the intervening 50 years as to what is technologically and economically feasible is the halogenated solvent cleaning industry, which, in response to EPA’s National Emission Standards for Hazardous Air Pollutants (NESHAP) promulgated under section 112 of the 1990 Clean Air Act Amendments (see National Emissions Standards for Halogenated Solvent Cleaning, 40 CFR part 63, subpart T), has made equipment E:\FR\FM\16JNP3.SGM 16JNP3 39658 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 improvements that conserve solvent resources and reduce workplace exposure. In sum, the great majority of OSHA’s chemical standards are outdated or do not sufficiently reduce 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, and because many of OSHA’s chemical-specific standards are based on outdated information regarding the technological and economic feasibility of the standards and the risks associated with exposure, 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. However, it is also appropriate that EPA consider the chemical standards that OSHA has already developed to limit the compliance burden to employers by aligning management approaches required by the agencies, where alignment will adequately address unreasonable risk to workers. The following unit discusses EPA’s consideration of OSHA standards in its risk evaluation and management strategies under TSCA. 2. Consideration of OSHA Standards in TSCA Risk Evaluations When characterizing the risk during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where no mitigation measures are assumed to be in place for the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It should be noted that there are some cases where scenarios may reflect certain mitigation measures, such as in instances where exposure estimates are based on monitoring data VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 at facilities that have existing engineering controls in place. For example, the Halogenated Solvent Cleaning NESHAP, first promulgated in 1994 and last updated in 2007, established standards reflecting the maximum achievable control technology for major and certain area sources, standards reflecting generally available control technology for other area sources, and facility-wide emission limits for certain halogenated solvent cleaning machines. Consequently, emissions monitoring from facilities meeting the NESHAP would reflect emissions reduction resulting from existing engineering controls already in place to meet the standards.) In addition, EPA believes it may be appropriate to also evaluate the levels of risk present in scenarios considering applicable OSHA requirements as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. EPA may evaluate risk under scenarios that consider industry or sector best practices for industrial hygiene that are clearly articulated to the Agency, when doing so serves to inform its risk management efforts. Characterizing risks using scenarios that reflect different levels of mitigation can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address any unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.). a. Risk Characterization for Unreasonable Risk Determination When making unreasonable risk determinations as part of TSCA risk evaluations, EPA cannot assume as a general matter that all workers are always equipped with and appropriately using sufficient PPE, although it does not question the veracity of public comments received on the 2020 Risk Evaluation for PCE regarding the occupational safety practices often followed by industry respondents. When characterizing the risk to human health from occupational exposures during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where PPE is not assumed to be used by workers. This approach of not assuming PPE use by workers considers the risk to PESS (workers and occupational non-users (ONUs)) who may not be covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan. Mitigation scenarios included in the EPA risk evaluation in order to inform its risk PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 management efforts (e.g., scenarios considering use of PPE) likely represent current practice in many facilities where companies effectively address worker and bystander safety requirements. However, the Agency cannot assume that all facilities across all uses of the chemical substance will have adopted these practices for the purposes of making the TSCA risk determination. Therefore, EPA makes its determinations of unreasonable risk based on scenarios that do not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on such scenarios should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by an OSHA State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements. b. Risk Evaluation To Inform Risk Management Requirements In addition to the scenarios described previously, EPA risk evaluations may characterize the levels of risk present in scenarios considering applicable OSHA requirements (e.g., chemical-specific PELs and/or chemical-specific health standards with PELs and additional ancillary provisions) as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency to help inform risk management decisions. 3. Consideration of OSHA Standards in TSCA Risk Management Actions When undertaking risk management actions, EPA: (1) Develops occupational risk mitigation measures to address any unreasonable risk identified by EPA, striving for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls (Ref. 8), when those measures would address an unreasonable risk; and (2) Ensures that EPA requirements apply to all potentially exposed workers in accordance with TSCA requirements. E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 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 applicability of TSCA while avoiding the imposition of duplicative requirements. Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, broadly applicable regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply to them or not be sufficient to address the unreasonable risk. For evaluation scenarios which involve OSHA chemical-specific PELs, EPA’s risk evaluation in some cases may illustrate that limiting exposure to OSHA’s PEL would result in acceptable levels of risk under TSCA under certain conditions of use. In these cases, TSCA risk management requirements could incorporate and reinforce requirements in OSHA standards and ensure that risks are addressed, including for circumstances where OSHA requirements are not applicable (e.g., public sector workers not covered by an OSHA State plan, and self-employed workers) by asserting TSCA compliance/enforcement as well. EPA’s risk evaluation may also find unreasonable risk under TSCA associated with some occupational conditions of use, even when the applicable OSHA requirements are being met. In these cases, EPA would need to develop risk management requirements beyond those included in OSHA’s standards. 4. PCE and OSHA Requirements EPA incorporated the considerations described earlier in this unit in the 2020 Risk Evaluation for PCE, the December 2022 revised unreasonable risk determination for PCE, and this rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for PCE, EPA presented risk estimates based on workers’ exposures with and without respiratory protection. EPA determined that even when respirators are used by workers, most of the conditions of use evaluated presented an unreasonable risk. Additional consideration of OSHA standards in the revised unreasonable risk determination is discussed further in the Federal Register notice announcing that document (Ref. 9). In Units III.B.3. and Unit V., EPA outlines VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 the importance of considering the hierarchy of controls utilized by the industrial hygiene community (hereafter referred to as ‘‘hierarchy of controls’’) when developing risk management actions in general, and specifically when determining if and how regulated entities may meet a risk-based exposure limit for PCE. The hierarchy of controls is a prioritization of exposure control strategies from most protective and preferred to least protective and preferred techniques. In order of precedence, they are: elimination of the hazard, substitution with a less hazardous substance, engineering controls, administrative controls such as training or exclusion zones with warning signs, and, finally, use of PPE (Ref. 8). Under the hierarchy of controls the use of respirators (and all PPE) should only be considered after all other measures have been taken to reduce exposures. As discussed in Units IV.A. and V.A.1., EPA’s risk management approach would not rely solely or primarily on the use of respirators and dermal PPE to address unreasonable risk to workers; instead, EPA is proposing prohibitions for most conditions of use and a WCPP for certain occupational conditions of use. The WCPP would require consideration of the hierarchy of controls before use of respirators and other PPE. The WCPP is discussed in full in Units IV.A.2. and V.A.1.b. In accordance with the approach described earlier in Unit II.C.3., EPA intends for this regulation to be as consistent as possible with the existing OSHA standards, with additional requirements as necessary to address the unreasonable risk. One notable difference between the WCPP and the OSHA standards are the exposure limits. The WCPP would include an ECEL of 0.14 ppm as an 8-hour TWA to address unreasonable risk for chronic cancer and non-cancer and acute noncancer inhalation endpoints. EPA recognizes that for PCE, the ECEL would be significantly lower than the OSHA PEL (100 ppm as an 8-hour TWA). In addition to the distinctions in statutory requirements described in this unit, EPA has identified several factors contributing to the differences in these levels, outlined here. The TSCA ECEL value for PCE is a lower value than the OSHA PEL (and other existing OELs, discussed in Unit II.C.5.) for many reasons, including the age of the data and studies the values are based on and that the values may not fully capture either the complete database of studies considered in the 2020 Risk Evaluation for PCE or more recent advances in modeling and scientific interpretation of toxicological PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 39659 data applied in the calculation of the PCE ECEL. EPA considers the PCE ECEL to represent the best available science under TSCA section 26(h) because it was derived from information in the 2020 Risk Evaluation for PCE, which was subject to peer review, and which is the result of a systematic review process that investigated the reasonably available information in order to identify relevant adverse health effects. Additionally, by using the information from the 2020 Risk Evaluation for PCE, the ECEL incorporates advanced modeling and peer-reviewed methodologies, and accounts for exposures to potentially exposed and susceptible subpopulations, as required by TSCA. For PCE, the EPA ECEL is an 8-hour occupational inhalation exposure limit based on chronic non-cancer neurotoxicity effects, and takes into consideration the uncertainties identified in the 2020 Risk Evaluation for PCE (Ref. 10). The ECEL represents the concentration at which an adult human, including a member of a PESS, would be unlikely to suffer adverse effects if exposed for a working lifetime. EPA has determined as a matter of risk management policy that ensuring exposures remain at or below the ECEL will eliminate any unreasonable risk of injury to health from occupational inhalation exposures. In addition to the ECEL, as part of this rulemaking EPA is proposing an ECEL action level, a value half of the ECEL, that would trigger additional monitoring to ensure that workers are not exposed to concentrations above the ECEL. For PCE, the ECEL of 0.14 ppm is based on the most sensitive point of departure across acute, chronic noncancer, and cancer endpoints. Neurotoxicity based on visual and cognitive deficits following chronic exposure was the basis of the PCE ECEL based on epidemiological data from Cavalleri et al., 1994 and Echeverria et al., 1995 (Refs. 10, 1, 11, 12). The ECEL incorporates a benchmark margin of exposure of 100 to account for human variability and the absence of a no-effect level in the studies. The OSHA PEL for PCE of 100 ppm as an 8-hour TWA was established in 1971. OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so (81 FR 16285). A 1989 update to 25 ppm based on a quantitative cancer risk assessment and technological feasibility analysis was later vacated by court order, reverting to the original PEL of 100 ppm (Ref. 13); (See also 54 FR 2332, 2686, 2688 (1989)). The basis of the 100 E:\FR\FM\16JNP3.SGM 16JNP3 39660 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 ppm PEL is unclear, however most original PELs were based on acute health effects only observable at higher concentrations as more sensitive chronic studies, including the chronic exposure studies used to inform the PCE ECEL, were not available at the time the PEL was established (see, e.g., 79 FR 61383, 61388). As discussed in Units II.D., III.B., and VII.D., the TSCA ECEL represents the best available science at time of publication of the 2020 Risk Evaluation for PCE. As described earlier, in a 2014 request for information OSHA described how, while new developments in science and technology from the time the PEL for PCE was established in 1971 may improve the scientific basis for making findings of significant risk, technical feasibility, or economic feasibility that is required under section 6(b)(5) of the OSH Act, OSHA has been unable to update the PEL for PCE and it remains frozen at the level that was originally adopted in 1971 (79 FR 61383, October 10, 2014). 5. PCE and Other Occupational Exposure Limits EPA is aware of other OELs for PCE, including the ACGIH TLV, the California Division of Occupational Safety and Health (Cal/OSHA) PEL, and the National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL). The 8-hour TWA TLV recommended by the ACGIH is 25 ppm. This TLV is based on ‘‘discomfort and subjective complaints’’ occurring at 100 ppm and above (Ref. 14). Neurological effects such as dizziness, headache, sleepiness, and incoordination were also indicated at 100 ppm and above. The TLV appears to use a four-fold ‘‘margin of safety’’ consistent with other TLV reports but lower than what would be recommended by EPA guidance (Ref. 15), which would support a downward adjustment of 30x-100x. The TLV report acknowledges that the liver effects were observed at as low as 9 ppm in mice after only 30 days of continuous exposure, however ACGIH determined that the exposure pattern was not representative of occupational scenarios. Additionally, quantitative risks from cancer were not considered because PCE was classified as only an animal carcinogen. Notably, the TLV report did not cite either epidemiological study used as the basis of the EPA ECEL, despite them being published 1–2 years prior to the 1996 TLV update. The Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and equivalent to the ACGIH TLV. The 25 ppm value is also equivalent to the vacated 1989 VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 OSHA PEL, which was based on a quantitative cancer risk assessment and technological feasibility analysis. Despite the Cal/OSHA PEL being equivalent to the vacated 1989 OSHA PEL based on cancer, Cal/OSHA did not perform a quantitative cancer risk assessment and the PEL is primarily based on non-cancer central nervous systems (CNS) effects (Ref. 16). In 1976, the NIOSH REL for PCE was 50 ppm as a TWA for up to a 10-hour workday, 40-hour workweek (Ref. 17). This REL was considered protective of neurological effects as well as eye and respiratory tract irritation. The current REL for PCE is ‘‘Ca (potential occupational carcinogen) minimize workplace exposure concentrations’’ (Ref. 18). As described in NIOSH’s Appendix A, this non-quantitative value is based on the lowest feasible concentration (Ref. 19). D. Summary of EPA’s Risk Evaluation Activities on PCE In December 2016, EPA selected PCE as one of the first 10 chemicals for risk evaluation under TSCA section 6 (15 U.S.C. 2605). EPA published the scope of the PCE risk evaluation in June 2017 (82 FR 31592, July 7, 2017) (FRL–9963– 57), and, after receiving public comments, published the problem formulation in June 2018 (83 FR 26998, June 11, 2018) (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 Evaluationfor 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 Unreasonable Risk Determination for PCE (87 FR 76481, December 14, 2022) (FRL–9942–01– OCSPP). The 2020 Risk Evaluation for PCE and supplemental materials are in docket EPA–HQ–OPPT–2019–0502, with the December 2022 revised unreasonable risk determination and additional materials supporting the risk evaluation process in docket EPA–HQ– OPPT–2016–0732, on https:// www.regulations.gov. 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal. Descriptions of these conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for PCE identified significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. A further discussion of the hazards of PCE is in Unit III.B.2. 2. Revised Unreasonable Risk Determination EPA has been revisiting specific aspects of its first ten TSCA existing chemical risk evaluations, including the 2020 Risk Evaluation for PCE, to ensure that the risk evaluations upon which risk management decisions are made better align with TSCA’s objective of protecting human health and the environment. For PCE, 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 (entitled ‘‘Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis’’) and other Administration priorities (Refs. 20, 21, and 22). The revisions consisted of making the risk determination based on the whole chemical substance instead of by individual conditions of use (which resulted in the revised risk determination superseding the prior ‘‘no unreasonable risk’’ determinations and withdrawing the associated TSCA section 6(i)(1) ‘‘no unreasonable risk’’ order); and clarifying that the risk determination does not reflect an assumption that all workers are always provided and appropriately wear PPE (Ref. 2). In determining whether PCE presents unreasonable risk under the conditions of use, EPA considered relevant riskrelated factors, including, but not limited to: the effects of the chemical substance on health (including cancer and non-cancer risks) and human exposure to the substance under the conditions of use (including duration, magnitude and frequency of exposure); the effects of the chemical substance on the environment and environmental exposure under the conditions of use; the population exposed (including any PESS); the severity of hazard (including the nature of the hazard, the E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 irreversibility of the hazard); and uncertainties. EPA determined that PCE presents an unreasonable risk of injury to health. The unreasonable risk determination is driven by risks to workers and ONUs (workers who do not directly handle the chemical but perform work in an area where the chemical is present) due to occupational exposures to PCE (i.e., during manufacture, processing, industrial and commercial uses, or disposal); to children of employees at dry cleaning facilities due to PCE exposures at those facilities; and to consumers and bystanders associated with consumer uses of PCE due to exposures from consumer use of PCE and PCE-containing products. EPA did not identify risks of injury to the environment that drive the unreasonable risk determination for PCE. The PCE conditions of use that drive 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., with descriptions to aid chemical manufacturers, processors, and users in determining how their particular use or activity would be addressed under the proposed regulatory provisions. While the 2020 Risk Evaluation for PCE estimated different risks for occupational non-users and workers, the benchmark (and thus the ECEL value) is the same for both populations. That is, while workers and occupational nonusers may have different exposure patterns, the level of exposure such that risks are no longer unreasonable is the same for both workers and occupational non-users. Thus, for the purposes of risk management, the distinction between worker and occupational non-user is no longer relevant, and both are encompassed by the definition of a potentially exposed person, as outlined in Unit IV.A.2.a. 3. Fenceline Screening Analysis The 2020 Risk Evaluation for PCE excluded the assessment of certain exposure pathways that were or could be regulated under another EPAadministered statute (see section 1.4.2 of the December 2020 Risk Evaluation for PCE) (Refs. 1, 2). This resulted in the surface water, drinking water, and ambient air pathways for PCE exposure not being assessed for human health risk to the general population. In June 2021, EPA made a policy announcement on the path forward for TSCA chemical risk evaluations, indicating that EPA would, among other things, examine whether the exclusion of certain exposure pathways from the risk evaluations VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 would lead to a failure to identify and protect fenceline communities (Refs. 9, 23). EPA then conducted a screening analysis to identify whether there may be potential risks to people living near the fenceline of facilities releasing PCE. In order to assess the potential risk to the general population in proximity to a facility releasing PCE, EPA developed the TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0, which was presented to the SACC in March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 24). This analysis is discussed in Unit VI.A. III. Regulatory Approach A. Background Under TSCA section 6(a), if the Administrator determines through a TSCA section 6(b) risk evaluation that the manufacture (including import), processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of such activities, presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more of the following requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk. • Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (TSCA section 6(a)(1)). • Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)). • Limit the amount of the substance or mixture which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use specified (TSCA section 6(a)(2)). • Require clear and adequate minimum 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 (TSCA section 6(a)(3)). • Require manufacturers and processors of the substance or mixture to make and retain certain records, or conduct certain monitoring or testing (TSCA section 6(a)(4)). • Prohibit or otherwise regulate any manner or method of commercial use of PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 39661 the substance or mixture (TSCA section 6(a)(5)). • Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture, or any article containing such substance or mixture, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (TSCA section 6(a)(6)). • Direct manufacturers or processors of the substance or mixture to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance or mixture (TSCA section 6(a)(7)). As described in Unit III.B.3., EPA analyzed how the TSCA section 6(a) requirements could be applied to address the unreasonable risk found to be present in the 2020 Risk Evaluation for PCE and the final revised unreasonable risk determination, so that PCE no longer presents such unreasonable risk. EPA’s proposed regulatory action and two alternative regulatory actions are described in Unit IV. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions and is providing notice that based on consideration of comments and any new information submitted to EPA during the comment period on this proposed rule, EPA may in the final rule modify elements of the proposed regulatory action. The public should understand that public comments could result in changes to elements of the proposed and alternative regulatory actions when this rulemaking is finalized. For example, elements such as timelines for phase out could be lengthened or shortened, ECELs could be modified, or the WCPP could have conditions added or eliminated. Under the authority of TSCA section 6(g), EPA may consider granting a timelimited exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use if EPA finds that: (1) The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (2) Compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or (3) The specific condition of use, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. Based on reasonably available information, EPA has analyzed E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39662 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules the need for an exemption and is proposing that a TSCA section 6(g) exemption is warranted for certain conditions of use, as detailed in Unit IV.A.5. EPA is requesting comment on the proposed rule’s section 6(g) exemption provisions and rationale. In addition, EPA has found that two TSCA section 6(g) exemptions may be warranted if the second alternative regulatory action considered by EPA is adopted in the final rule. Therefore, the public should assume that if EPA were to promulgate the second alternative to the proposed regulatory action, EPA would at the same time grant an exemption from the rule requirements for two conditions of use under TSCA section 6(g). Unit IV.B.2.b. includes information regarding EPA’s second alternative action that includes exemptions under TSCA section 6(g). EPA is requesting public comment regarding the need for exemptions from the rule (and under what specific circumstances), including exemptions from the proposed regulatory action (e.g., a WCPP) and the primary and second alternative regulatory actions, pursuant to the provisions of TSCA section 6(g). TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to consider and include a statement addressing certain factors, including the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. A description of all TSCA section 6 requirements considered in developing this proposed regulatory action is in Unit III.B.3., and Unit V. includes more information regarding EPA’s consideration of exemptions and alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use and in setting an appropriate transition period for such action, EPA consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as substitutes when the proposed prohibition or restriction takes effect. Unit V.B. includes more information regarding EPA’s consideration of alternatives, and Unit VI. provides more information on EPA’s considerations more broadly under TSCA section 6(c)(2). EPA carried out required consultations as described in this unit and also considered impacts on children’s environmental health as part VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 of its approach to developing this TSCA section 6 regulatory action. 1. Consultations EPA conducted consultations and outreach in developing this proposed regulatory action. The Agency held a federalism consultation from July 22, 2021, until October 22, 2021, as part of this rulemaking process and pursuant to Executive Order 13132. This included a background presentation on September 9, 2020, and a consultation meeting on July 22, 2021. During the consultation, EPA met with State and local officials early in the process of developing the proposed action in order to receive meaningful and timely input into its development (Ref. 25). During the consultation, participants and EPA discussed additional reporting requirements as a risk management tool to address the unreasonable risk, EPA’s consideration of safer alternatives, and potential impacts to drinking water utilities (Ref. 25). PCE is not manufactured (including imported), processed, distributed in commerce, or regulated by Tribal governments. However, EPA consulted with Tribal officials during the development of this proposed action (Ref. 26). The Agency held a Tribal consultation from May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8, 2021. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for PCE, types of information that would be helpful to inform risk management, principles for transparency during the risk management process, and types of information EPA is seeking from Tribes (Ref. 26). EPA received no written comments as part of this consultation. In addition to the formal consultations, EPA also conducted outreach to advocates of communities that might be subject to disproportionate risk from the exposures to PCE, such as minority populations, low-income populations, and indigenous peoples. EPA’s Environmental Justice (EJ) consultation occurred from June 3, 2021, through 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 and in compliance with Executive Orders 12898 and 14008. EPA received five written comments following the EJ meetings, in addition to oral comments provided during the consultation (Refs. 27, 28, 29, 30, 31). In PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 general, commenters supported strong outreach to affected communities, encouraged EPA to follow the hierarchy of controls utilized by the industrial hygiene community, favored prohibitions, and noted the uncertainty, and in some cases inadequacy, of PPE. Commenters also urged EPA to address in this rulemaking ongoing releases from hazardous waste and disposal sites, in particular vapor intrusion of PCE from contaminated groundwater, soil, and indoor air. Additionally, commenters expressed concern that the adverse health impacts of PCE dry cleaning fall disproportionately to owners and employees of minority owned small businesses, noted the viability of professional wet cleaning as an alternative to PCE dry cleaning, and urged EPA to consider adverse economic impacts of the regulation and establishing a financial program to offset transition costs to local communities (Ref. 32). 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 this proposed rule’s requirements (Ref. 33). EPA met with SERs before and during Panel proceedings, on September 26, 2022, and November 10, 2022. Panel recommendations are in Unit X.C. and in the Initial Regulatory Flexibility Analysis (IRFA) (Ref. 34), the Panel report is in the docket (Ref. 33). EPA requests comment on all elements of the IRFA, and, in particular, the flexibilities that EPA has identified following input from the SERs during the SBAR process. Additional requests for comment based on Panel recommendations are in Unit VIII. Units X.C., X.E., X.F., and X.J. provide more information regarding the consultations. 2. Other Stakeholder Engagement In addition to the formal consultations described in Unit X., EPA held a webinar on January 14, 2021, providing an overview of the TSCA risk management process and the risk evaluation findings for PCE. EPA also presented on the risk evaluation and risk management under TSCA for PCE at a Small Business Administration (SBA) Office of Advocacy Environmental roundtable on January 15, 2021. At both events, EPA staff provided an overview of the TSCA risk management process and the findings in the 2020 Risk Evaluation for PCE (Ref. 35). Attendees of these meetings were given an opportunity to voice their concerns E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 regarding the risk evaluation and risk management. Furthermore, EPA engaged in discussions with representatives from different industries, non-governmental organizations, technical experts and users of PCE. A list of external meetings held during the development of this proposed rule is in the docket (Ref. 36); meeting materials and summaries are also in the docket. The purpose of these discussions was to create awareness and educate stakeholders and regulated entities on the provisions for risk management required under TSCA section 6(a); explain the risk evaluation findings; obtain input from manufacturers, processors, distributors, users, academics, advisory councils, and members of the public health community about uses of PCE; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to PCE under the conditions of use; understand the importance of PCE in the various uses subject to this proposed rule; compile knowledge about critical uses, substitute chemicals or alternative methods; identify various standards and performance specifications; and generate potential risk reduction strategies. EPA has met with, or otherwise communicated with, a variety of companies, trade associations and non-governmental organizations to discuss the topics outlined in this paragraph; a list of external meetings held during the development of this proposed rule is in the docket (Ref. 36). 3. Children’s Environmental Health The EPA 2021 Policy on Children’s Health (Ref. 37) 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.’’ Infants, children, and pregnant women are listed as examples of subpopulations that may be considered relevant ‘‘potentially VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 exposed or susceptible subpopulations’’ in the TSCA section 3(12) definition of that term. 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 (including unreasonable risk to PESS). The 2020 Risk Evaluation for PCE evaluated the hazards of PCE to toddlers and older children (11–15 years and 16– 20 years) and did not find disproportionate adverse health impacts to these groups (Ref. 1). Evidence of hazards to infants and males and females of reproductive age was found for reproductive and developmental toxicity. The reproductive and developmental health effects of concern related to exposures to PCE are reduced sperm quality, spontaneous abortion, and decreased fetal/placental weight. The most sensitive non-cancer hazard driving the unreasonable risk for PCE is neurotoxicity (CNS effects). Early lifestage development of the nervous system can be a sensitive period, however the studies on PCE do not provide sufficient evidence of greater sensitivity to neurotoxicity in early lifestages than later lifestages, such as during adulthood. While the literature contains methodological limitations in human studies, animal studies were considered adequate to represent reproductive and development effects in the 2020 Risk Evaluation for PCE. The 2020 Risk Evaluation for PCE released in December 2020 considered impacts on both children and adults from occupational and consumer use from inhalation and dermal exposures, as applicable. For occupational use, the risk evaluation considered males (≤16 years of age) and females of reproductive age (≤16 years of age to less than 50 years of age) for both dermal and inhalation exposures. Additionally, because many dry cleaners are family owned and operated, the risk evaluation assumed children of employees may spend the full workday at dry cleaning facilities, in particular those too young to be in school, during which time they may be exposed to similar air concentration levels as ONUs. The risk evaluation considered inhalation exposures to children of employees present at dry cleaners by evaluating central nervous system effects for the most sensitive lifestage: infants less than one year old. Children of employees present at dry cleaners would be exposed to higher PCE concentrations than children who live or attend daycare or school above or adjacent to dry cleaners, and EPA therefore expects that risks to those populations are covered by evaluation PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 39663 of children within dry cleaning facilities. For consumer use, EPA evaluated dermal exposures for children ages 11 to 15 and 16 to 20 years of age and adults >20 years of age, and the evaluation of bystander exposure from inhalation exposures includes infants, toddlers and older children. While risks to children are not disproportionate, effects observed in studies include central nervous system effects from acute inhalation exposure. B. Regulatory Assessment of PCE 1. Description of Conditions of Use This unit describes the TSCA conditions of use that drive EPA’s unreasonable risk determination for the chemical substance PCE. Condition of use descriptions were obtained from EPA sources such as CDR use codes, the 2020 Risk Evaluation for PCE and related documents, as well as the Organisation for Economic Co-operation and Development harmonized use codes and stakeholder engagements. For additional description of the conditions of use, including process descriptions and worker activities considered in the risk evaluation, see the Problem Formulation of the 2020 Risk Evaluation for PCE, the 2020 Risk Evaluation for PCE, and supplemental files (Refs. 38, 1, 39). EPA acknowledges that some of the terms in this unit may be defined under other statutes, however the descriptions here are intended to provide clarity to the regulated entities who will implement the provisions of this rulemaking under TSCA section 6(a). a. Manufacturing (Including Import) i. Domestic manufacture. This condition of use refers to the making or producing of a chemical substance within the United States (including manufacturing for export), or the extraction of a component chemical substance from a previously existing chemical substance or a complex combination of substances. This description does not apply to PCE production as a byproduct, including during the manufacture of 1,2dichloroethane which EPA intends to consider in the risk evaluation for 1,2dichloroethane (Ref. 40). ii. Import. This condition of use refers to the act of causing a chemical substance or mixture to arrive within the customs territory of the United States. b. Processing i. Processing as a reactant/ intermediate. This condition of use refers to processing PCE in chemical reactions for the manufacturing of E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39664 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules another chemical substance or product. Through processing as a reactant or intermediate, PCE serves as a feedstock in the production of another chemical product via a chemical reaction in which PCE is completely consumed. For example, PCE is used as a reactant in the production of HFCs, hydrochlorofluorocarbons (HCFCs), and chlorofluorocarbons (CFCs). This condition of use includes reuse of PCE, including PCE originally generated as a byproduct or residual PCE as a reactant. ii. Processing into formulation, mixture or reaction product in cleaning and degreasing products. This condition of use refers to when PCE is added to a cleaning or degreasing product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate cleaning or degreasing products that are used to remove dirt and dissolve oils, greases, and similar materials from textiles, glassware, metal surfaces, furniture, furnishings, and other articles, or to cleanse, sanitize, bleach, scour, polish, protect, or improve the appearance of surfaces. iii. Processing into formulation, mixture or reaction product in adhesive and sealant products. This condition of use refers to when PCE is added to an adhesive or sealant product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate products that promote bonding between other substances, promote adhesion of surfaces, or prevent seepage of moisture or air. iv. Processing into formulation, mixture or reaction product in paint and coating products. This condition of use refers to when PCE is added to a paint or coating product (or product mixture) prior to further distribution of the product. For example, formulators may mix PCE at varying concentrations with other additives to formulate paint and coating products that are applied to surfaces to enhance properties such as water repellency, gloss, fade resistance, ease of application, or foam prevention. Additionally, PCE is incorporated into coating products, such as maskant, that protect a substrate during exposure to a chemical process such as chemical milling, plating, and anodizing. v. Processing into formulation, mixture or reaction product in other chemical products and preparations. This condition of use refers to when PCE is added to other chemical products (or product mixtures) or preparations prior to further distribution of the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 product. For example, formulators may mix PCE at varying concentrations with other additives to formulate inks, toners, colorants, photographic supplies, lubricants, greases, mold releases, and other products. vi. Processing by repackaging. This condition of use refers to the preparation of a chemical substance or mixture for distribution in commerce in a different form, state, or quantity. This includes transferring of PCE from a bulk container into smaller containers. vii. Recycling. This condition of use refers to processing waste streams of PCE at a third-party site for the purpose of recovering materials or otherwise preparing the waste for reuse instead of disposal. Waste solvents can be restored via solvent reclamation/recycling. The recovery process may involve an initial vapor recovery or mechanical separation step followed by distillation, purification, and final packaging. c. Industrial and Commercial Use i. Industrial and commercial use as solvent for open-top batch vapor degreasing. This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch open-top vapor degreaser machines. ii. Industrial and commercial use as solvent for closed-loop batch vapor degreasing. This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch closed-loop degreaser machines. iii. Industrial and commercial use as solvent for in-line conveyorized vapor degreasing. This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through the process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using in-line conveyorized vapor degreaser machines. iv. Industrial and commercial use as solvent for in-line web cleaner vapor degreasing. This condition of use refers to the industrial and commercial use of PCE as a solvent for cleaning and degreasing through a process of heating PCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 metal and other parts using web vapor degreaser machines. v. Industrial and commercial use as solvent for cold cleaning. This condition of use refers to the industrial and commercial use of PCE as a non-boiling solvent in cold cleaning machines, including simple spray sinks and dip tanks, to remove dirt, oils, greases, and other surface contaminants from metal and other parts. vi. Industrial and commercial use as solvent for aerosol spray degreaser/ cleaner. This condition of use refers to the industrial and commercial use of PCE as a solvent in degreasing and cleaning products to remove dirt, grease, stains, spots, and foreign matter through a process that uses an aerosolized solvent spray, typically applied from a pressurized can, to remove residual contaminants from electronics, metals, and other fabricated materials. This description includes use of PCE in products for energized electrical cleaning for equipment with an electrical current running through it, such as electric motors, armatures, relays, electric panel, generators, and other equipment. This description does not apply to use of PCE in products intended for automotive care, welding, or mold cleaning, which are described in different conditions of use. vii. Industrial and commercial use as a solvent for aerosol lubricants. This condition of use refers to the industrial and commercial use of PCE in aerosolized products to reduce friction, heat generation and wear between solid surfaces. viii. Industrial and commercial use as a solvent for penetrating lubricants and cutting tool coolants. This condition of use refers to the industrial and commercial use of PCE in liquid products such as metalworking, cutting, and tapping fluids, including penetrating lubricants and cutting tool coolants, to reduce friction, heat generation and wear between solid surfaces. ix. Industrial and commercial use in solvent-based adhesives and sealants. This condition of use refers to the industrial and commercial use of PCE as a solvent in adhesive and sealant products to promote bonding between other substances, promote adhesion of surfaces, or prevent seepage of moisture or air. x. Industrial and commercial use in solvent-based paints and coatings. This condition of use refers to the industrial and commercial use of PCE as a solvent in paint and coating, including maskant, that is applied to surfaces to enhance properties such as water repellence, increased gloss, improved fade E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules resistance, ease of application, and foam prevention. This description does not apply to the use of PCE in maskant for chemical milling, which is described in a different condition of use xi. Industrial and commercial use in maskant for chemical milling. This condition of use refers to the industrial and commercial use of PCE as a solvent in maskants or elastomer-based coatings that are used to protect a substrate during exposure to a chemical process, such as chemical milling, plating and anodizing. xii. Industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing. This condition of use refers to the industrial and commercial use of PCE to improve the processing characteristics or the operation of process equipment or to alter or buffer the pH of the substance of mixture during the production of non-pesticidal products used to increase the productivity and quality of plant, animal and forestry crops produced on a commercial scale. Processing aids are added to a reaction mixture to aid in the manufacture or synthesis or another chemical substance but are not intended to remain in or become part of the product or product mixture or affect the function of a substance or article created. xiii. Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing. This condition of use refers to the industrial and commercial use of PCE to improve processing characteristics or the operation of process equipment during the production of oil, gas, and other similar products. For example, PCE is used in both reforming and isomerization processes at refineries. In the reforming process, PCE is added directly to a regenerator in a Continuous Catalytic Regeneration reforming unit, and in the isomerization process, PCE is added to the hydrocarbon feed. In both processes, PCE provides chlorine ions to regenerate the catalysts and is consumed in the process. xiv. Industrial and commercial use in wipe cleaning. This condition of use refers to the industrial and commercial use of PCE in non-aerosol degreasing and cleaning products to remove dirt, grease, stains, spots, and foreign matter from furniture and furnishings or to cleanse, sanitize, bleach, scour, polish, protect, or improve the appearance of surfaces through wipe cleaning. xv. Industrial and commercial use in other spot cleaning and spot removers, including carpet cleaning. This condition of use refers to the industrial and commercial use of PCE in products VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 to remove dirt, grease, stains, spots, and foreign matter from furniture and furnishes, including carpets and rugs. This description does not apply to the use of PCE as a spot cleaner at dry cleaning facilities, which is described under other conditions of use. xvi. Industrial and commercial use in mold release. This condition of use refers to the industrial and commercial use of PCE in products to remove dirt, grease, stains, spots, and foreign matter, including release agent residues, from molds and casting surfaces. xvii. Industrial and commercial use in dry cleaning and spot cleaning post2006 dry cleaning. This condition of use refers to industrial and commercial use of PCE in products for spot cleaning and as a solvent in degreasing and cleaning applications to remove dirt, grease, stains, spots, and foreign matter from garments at dry cleaning facilities that use PCE dry cleaning machines after the promulgation of the 2006 PCE NESHAP for Dry Cleaning Facilities (40 CFR part 63, subpart M). This includes dry cleaning facilities using third generation (dry-to-dry, non-vented machines with refrigerated condensers), fourth generation (dry-to-dry, non-vented machines with both refrigerated condensers and carbon adsorbers as secondary vapor controls), or fifth generation (dry-to-dry, non-vented machines with secondary vapor controls, a monitor inside the machine drum, and an interlocking system to ensure the concentration is below approximately 300 ppm before the loading door can be opened) PCE dry cleaning machines. xviii. Industrial and commercial use in dry cleaning and spot cleaning 4th/ 5th gen only dry cleaning. This condition of use refers to industrial and commercial use of PCE in products for spot cleaning and as a solvent in degreasing and cleaning applications to remove dirt, grease, stains, spots, and foreign matter from garments at dry cleaning facilities that use fourth generation or fifth generation PCE machines. In addition to use as a solvent in dry cleaning equipment, PCE is found in products to spot clean garments to remove stains or spots before and after dry cleaning treatment. xix. Industrial and commercial use in automotive care products (e.g., engine degreaser and brake cleaner). This condition of use refers to the industrial and commercial use of PCE in aerosolized products to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces. This description includes use of products for motorized vehicle maintenance and their parts, but does PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 39665 not include energized electrical cleaners, which is covered by the industrial and commercial use as a solvent for aerosol spray degreaser/ cleaner. Additionally, this description does not include use of non-aerosolized products intended for automotive care, which are covered by different conditions of use. xx. Industrial and commercial use in non-aerosol cleaner. This condition of use refers to the industrial and commercial use of PCE in non-aerosol products to remove dirt, grease, stains, and foreign matter from furniture, furnishings, interior or exterior vehicles, and other materials, or to clean, sanitize, bleach scour, polish, or improve the appearance of surfaces in all other applications not specified elsewhere in this section. xxi. Industrial and commercial use in metal (e.g., stainless steel) and stone polishes. This condition of use refers to the industrial and commercial use of PCE in non-aerosolized products for metal (e.g., stainless steel) and stone polishing applications, including stone and marble cleaner and wax. xxii. Industrial and commercial use in laboratory chemicals. This condition of use refers to the industrial and commercial use of PCE, often in small quantities, in a laboratory process or in specialized laboratory equipment for instrument calibration/maintenance chemical analysis, chemical synthesis, extracting and purifying other chemicals, dissolving other substances, executing research, development, test and evaluation methods, and similar activities. xxiii. Industrial and commercial use in welding. This condition of use refers to the industrial and commercial use of PCE in welding applications. For example, PCE can be found in aerosolized products that cast or join materials, promote the fusing of minerals, and prevent oxide formation, including products that reduce welding spatter or prevent the spatter from sticking to surfaces. xxiv. Industrial and commercial use in other textile processing. This condition of use refers to the industrial and commercial use of PCE in processing textile products not described elsewhere. For example, PCE is used as a scourer and for sizing and finishing of cloth. xxv. Industrial and commercial use in wood furniture manufacturing. This condition of use refers to the industrial and commercial use of PCE in the manufacture of wood furniture or wood furniture components (including household furniture, wood office furniture, wood containers and pallets, E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39666 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules and all other wood products) not described elsewhere. xxvi. Industrial and commercial use in foundry applications. This condition of use refers to the industrial and commercial use of PCE in metal foundry, smelting, and metallurgical applications not described elsewhere, such as soldering/desoldering, at nonferrous metal foundries (except diecasting), nonferrous metal diecasting foundries, aluminum foundries, and iron foundries. xxvii. Industrial and commercial use in specialty Department of Defense uses (oil analysis and water pipe repair). During the risk evaluation, the Department of Defense (DOD) provided monitoring data for PCE in various uses, including for oil analysis and water pipe repair. This condition of use refers to the industrial and commercial use of PCE in specialty DOD uses in oil analysis and water pipe repair. After the risk evaluation was published, DOD determined there is no current data to indicate that PCE is required for these specialty uses. xxviii. Commercial use in inks and ink removal products (based on printing). This condition of use refers to the commercial use of PCE in ink and ink removal products used in printing for writing, printing, or creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates such as cleaning machines or printing plates, at print shops. xxix. Commercial use in inks and ink removal products (based on photocopying). This condition of use refers to the commercial use of PCE in ink and ink removal products used in photocopying for writing, printing, creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates such as cleaning machines or printing plates. xxx. Commercial use in photographic film. This condition of use refers to the commercial use of PCE in photographic supplies, film, photoprocessing chemicals, and photographic paper. For example, PCE is used as a liquid-gate fluid to help protect scratching of optical negatives during filming. xxxi. Commercial use in metal mold cleaning, release and protectant products. This condition of use refers to the commercial use of PCE in mold release products to create barriers to prevent certain materials from adhering to each other. This description does not apply to the use of PCE in mold cleaning products that remove residual VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 This condition of use refers to the consumer use of PCE in aerosolized products to reduce friction, heat generation and wear between solid d. Consumer Use surfaces, including lubricant and i. Consumer use in cleaners and penetrating oils. degreasers (other). This condition of use ix. Consumer use in adhesives for arts refers to the consumer use of PCE as a and crafts (including industrial solvent in degreasing and cleaning adhesive, arts and crafts adhesive, gun products use to remove dirt, grease, ammunition sealant). This condition of stains, spots, and foreign matter through use refers to the consumer use of PCE a process that uses an aerosolized as an adhesive in arts, crafts, and hobby solvent spray, typically applied from a products to promote bonding between pressurized can, to remove residual other substances, promote adhesion of contaminants from electronics, metals, surfaces, or prevent seepage of moisture and other fabricated materials not or air, in particular industrial adhesive, described elsewhere in this section. adhesive for arts and crafts, and gun ii. Consumer use in dry cleaning ammunition sealant. For example, PCE solvent. This condition of use refers to may be used in gun ammunition sealant consumer exposure to PCE used to products to ensure no moisture gets into remove dirt, grease, stains, spots, and ammunition casings. x. Consumer use in adhesives for arts foreign matter from garments via dry and crafts (livestock grooming cleaning, in particular the adhesive). This condition of use refers transportation, storage, and wear of articles that were dry cleaned with PCE. to the consumer use of PCE in livestock grooming adhesive spray. For example, garments that are dry xi. Consumer use in adhesives for arts cleaned at facilities that use PCE as a and crafts (column adhesive, caulk and dry cleaning solvent have residual sealant). This condition of use refers to concentrations of PCE remaining in the the consumer use of PCE for column article after a dry cleaning event. adhesive, caulk and sealant. iii. Consumer use in automotive care xii. Consumer use in solvent-based products (brake cleaner). This condition of use refers to the consumer use of PCE paints and coatings (outdoor water shield (liquid)). This condition of use in aerosolized products to remove dirt, refers to the consumer use of PCE in grease, stains, and foreign matter from solvent-based non-aerosol paint and interior and exterior vehicle surfaces, coating products to enhance properties including brake cleaner. such as water repellence, increased iv. Consumer use in automotive care products (parts cleaner). This condition gloss, improved fade resistance, ease of of use refers to the consumer use of PCE application, or foam prevention, in particular the use in outdoor water in non-aerosolized products that are to shield sealants and coatings. remove dirt, grease, stains, and foreign xiii. Consumer use in solvent-based matter from interior and exterior vehicle paints and coatings (coating and surfaces, including parts cleaner. primers (aerosol)). This condition of use v. Consumer use in aerosol cleaner refers to the consumer use of PCE in (vandalism mark and stain remover). solvent-based paint and coating aerosol This condition of use refers to the products to enhance properties such as consumer use of PCE in aerosolized products for cleaning and furniture care, water repellence, increased gloss, improved fade resistance, ease of including vandalism mark and stain application, or foam prevention, in remover. particular the use in aerosolized coating vi. Consumer use in non-aerosol and primers. cleaner (e.g., marble and stone polish). xiv. Consumer use in solvent-based This condition of use refers to the consumer use of PCE in non-aerosolized paints and coatings (rust primer and products for cleaning and furniture care, sealant (liquid)). This condition of use typically in the form of a solid or liquid refers to the consumer use of PCE in solvent-based paint and coating liquid cleaner not described elsewhere in this products to enhance properties such as section, including liquid marble and water repellence, increased gloss, stone polish. improved fade resistance, ease of vii. Consumer use in lubricants and greases (cutting fluid). This condition of application, or foam prevention, in particular the use in liquid rust primer use refers to the consumer use of PCE and sealant. in non-aerosolized products to reduce xv. Consumer use in solvent-based friction, heat generation and wear paints and coatings (metallic overglaze). between solid surfaces, including This condition of use refers to the cutting fluid. consumer use of PCE in solvent-based viii. Consumer use in lubricants and greases (lubricants and penetrating oils). paint and coating products to enhance coatings from mold release, which is described under a different condition of use. PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules properties such as water repellence, increased gloss, improved fade resistance, ease of application, or foam prevention, in particular the use in solvent based metallic overglaze for ceramics. xvi. Consumer use in metal (e.g., stainless steel) and stone polishes. This condition of use refers to the consumer use of PCE in liquid wax-based products for metal (e.g., stainless steel) and stone polishing. xvii. Consumer use in inks and ink removal products. This condition of use refers to the consumer use of PCE in ink and ink removal products for writing, printing, creating an image on paper and other substrates, applied to substrates to change their color or hide images, or to remove dirt and other contaminants from substrates. xviii. Consumer use in welding. This condition of use refers to the consumer use of PCE in products that cast or join materials, promote the fusing of minerals, or prevent oxide formation, including products that reduce welding spatter or prevent the spatter from sticking to surfaces. xix. Consumer use in metal mold cleaning, release and protectant products. This condition of use refers to the consumer use of PCE in products to create barriers to prevent certain materials from adhering to each other and assist in the removal of dirt, grease, oils, and other contaminants from metal molds, machinery, electrical and electronic equipment, pins, and mechanical equipment. ddrumheller on DSK120RN23PROD with PROPOSALS3 e. Disposal This condition of use refers to the process of disposing generated waste streams of PCE that are collected and transported to a third-party site for their final disposition, such as waste incineration or landfilling. f. Terminology in This Proposed Rule For purposes of this proposed rulemaking ‘‘occupational conditions of use’’ refers to the TSCA conditions of use described in Units III.B.1.a., b., c., and e. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for PCE 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, in the 2020 Risk Evaluation for the chemical substance PCE, EPA identified and assessed all known, intended, and reasonably VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 foreseen industrial, commercial, and consumer uses of PCE in order to determine whether PCE as a whole chemical substance presents unreasonable risks to health and the environment. EPA determined that all industrial, commercial, and consumer uses of PCE evaluated in the 2020 Risk Evaluation for PCE drive the EPA determination that PCE presents unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, ‘‘consumer use’’ refers to all consumer uses including known, intended, and reasonably foreseen consumer uses of PCE. Likewise, for the purpose of this risk management rulemaking, ‘‘industrial and commercial use’’ refers to all industrial and commercial uses, including known, intended, or reasonably foreseen PCE industrial and commercial use. EPA is not proposing to incorporate the descriptions of known, intended or reasonably foreseen conditions of use in Unit III.B.1.a through e into the regulatory text as definitions because these conditions of use represent those evaluated in the 2020 Risk Evaluation for PCE whereas the regulatory text applies to all TSCA consumer and industrial/commercial uses. EPA requests comment on whether EPA should promulgate definitions for those conditions of use evaluated in the 2020 Risk Evaluation for PCE that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for PCE and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation if EPA were to promulgate a regulation that contains a list of the industrial and commercial conditions of use evaluated in the 2020 Risk Evaluation for PCE. EPA further notes that this proposed 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 (FFDCA), when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device. PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 39667 2. Description of Unreasonable Risk Under the Conditions of Use EPA has determined that PCE presents an unreasonable risk of injury to human health under the conditions of use based on acute and chronic noncancer risks and chronic cancer risks (Ref. 2). As described in the TSCA section 6(b) 2020 Risk Evaluation for PCE, EPA identified non-cancer adverse effects from 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 noncancer 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). Additional risks associated with other adverse effects (e.g., kidney, liver, immune system, and developmental toxicity) were identified for acute and chronic exposures. EPA also concluded, based on EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 41), that PCE is likely to be carcinogenic to humans by all routes of exposure and calculated cancer risks from chronic inhalation and dermal exposures. Unit VI.A. summarizes the health effects and the magnitude of exposures (Ref. 1). To make the unreasonable risk determination for PCE, EPA evaluated exposures to workers, ONUs, children of workers at dry cleaners, consumer users, and bystanders to consumer use using reasonably available monitoring and modeling data for inhalation and dermal exposures (Ref. 2). EPA conducted a screening level analysis to assess potential risks from the air and water pathways to fenceline communities. A discussion of EPA’s analysis and the expected effects of this rulemaking on fenceline communities is in Unit VI.A. For the 2020 Risk Evaluation for PCE, EPA considered PESS. EPA identified the following groups as PESS: workers, ONUs, children of workers at dry cleaners, consumers, bystanders, developing fetuses (and by extension, women of childbearing age), and those with certain pre-existing health conditions, higher body fat content, or particular genetic polymorphisms (Ref. 1). All PESS are included in the quantitative and qualitative analyses described in the risk evaluation, and were considered in the determination of unreasonable risk for PCE. As discussed in Unit II.D. and Unit VI.A., the 2020 Risk Evaluation for PCE excluded the air and water exposure pathways to the general population from the published E:\FR\FM\16JNP3.SGM 16JNP3 39668 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 risk evaluations and may have caused some risks to be unaccounted for in the risk evaluation. EPA considers these receptors a subset of the general population and categorizes them as fenceline communities; they may also be considered PESS. See Unit VI.A. for further discussion on assessing and protecting against risk to fenceline communities. 3. Description of TSCA Section 6 Requirements for Risk Management EPA examined the TSCA section 6(a) requirements (listed in Unit III.A.) to identify which ones have the potential to eliminate the unreasonable risk for PCE. This Unit summarizes the TSCA section 6 considerations for issuing regulations under TSCA section 6(a). Unit V. outlines how EPA applied these considerations specifically to managing the unreasonable risk from PCE. As required, EPA developed a proposed regulatory action and one or more primary alternative regulatory actions, which are described in Units IV.A. and IV.B., respectively. 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 (see Unit III.B.1.f.), 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 does not have direct authority to regulate consumer use. Therefore, EPA 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 points 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 identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: (i) The effects of PCE on health and the environment; (ii) The magnitude of exposure to PCE of human beings and the environment; (iii) The benefits of PCE for various uses; and (iv) The reasonably ascertainable economic consequences of the rule. In evaluating the reasonably ascertainable economic consequences of the rule, EPA considered: (i) The likely effect of the rule on the national economy, small business, technological innovation, the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 environment, and public health; (ii) The costs and benefits of the proposed regulatory action and one or more primary alternative regulatory actions considered; and (iii) The cost effectiveness of the proposed regulatory action and of the one or more primary alternative regulatory actions considered. See Unit VI. for further discussion related to TSCA section 6(c)(2)(A) considerations, including the statement of effects of the proposed rule with respect to these considerations. EPA also considered the regulatory authority under TSCA and other statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and other EPAadministered statutes to examine: (1) Whether there are opportunities for all or part of risk management action on PCE to be addressed under other statutes, such that a referral may be warranted under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a) regulation could include alignment of requirements and definitions in and under existing statutes to minimize confusion to the regulated entities and the general public. In addition, EPA followed other TSCA requirements such as considering the availability of alternatives when contemplating prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as outlined in Unit V.B.), and setting proposed compliance dates in accordance with the requirements in TSCA section 6(d)(1) (described in the proposed and alternative regulatory actions in Unit IV.). To the extent information was reasonably available, when selecting regulatory actions, EPA considered pollution prevention and the hierarchy of controls adopted by OSHA and NIOSH, with the goal of identifying risk management control methods that are permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated entities where appropriate. EPA considered the information presented in the 2020 Risk Evaluation for PCE, as well as additional input from stakeholders (as described in Unit III.A.), and anticipated compliance strategies from regulated entities. Taken together, these considerations led EPA to the proposed regulatory action and primary alternative regulatory actions described in Unit IV. Additional details related to how the requirements in this unit were incorporated into development of those actions are in Unit V. As demonstrated by the number of distinct programs addressed in this rulemaking and the structure of this proposed rule in addressing them PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 independently, EPA generally intends the rule’s provisions to be severable from each other. EPA expects to provide additional detail on severability in the final rule once the Agency has considered public comments and finalized the regulatory language. IV. Proposed and Alternative Regulatory Actions This unit describes the proposed regulatory action by EPA so that PCE will no longer present an unreasonable risk of injury to health. In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider the costs and benefits and the cost-effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions. In the case of PCE, the proposed regulatory action is described in Unit IV.A. and the two alternative regulatory actions considered are described in Unit IV.B. An overview of the proposed regulatory action and two alternative regulatory actions for each condition of use is in Unit IV.C. The rationale for the proposed and alternative regulatory actions and associated compliance timeframes are discussed in this unit and in more detail in Unit V.A. A. Proposed Regulatory Action EPA is proposing under TSCA section 6(a) to: 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.A.1.a.; Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use, outlined in Unit IV.A.1.b.; Prohibit the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10year phaseout, outlined in Unit IV.A.1.c.; Require 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 16 occupational conditions of use not prohibited, outlined in Unit IV.A.2.; Require prescriptive workplace controls for laboratory use, outlined in Unit IV.A.3.; Establish recordkeeping and downstream notification requirements, outlined in Unit IV.A.4; and Provide a 10-year time limited exemption under TSCA section 6(g) for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available, outlined in Unit IV.A.5. As the manufacture and processing of PCE presents an unreasonable risk to health in the E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules United States, the manufacture and processing of PCE for export would also be prohibited or restricted in accordance with TSCA section 12(a)(2). 1. Prohibitions of Manufacturing, Processing, Distribution in Commerce, and Use ddrumheller on DSK120RN23PROD with PROPOSALS3 a. Prohibition of Certain Industrial and Commercial Uses and Manufacturing, Processing, and Distribution in Commerce of PCE for Those Uses EPA is proposing to prohibit the manufacturing, processing, distribution in commerce, and use of PCE for industrial and commercial uses, except for those uses which would continue under the WCPP (as described in Unit IV.A.2.), and laboratory use (as described in Unit IV.A.3.). The proposed prohibitions under TSCA would not apply to any use of PCE that is excluded from TSCA’s definition of ‘‘chemical substance’’ under TSCA section 3(2)(B)(ii) through (vi). This proposed prohibition would include a prohibition on the manufacturing, processing, distribution in commerce, and use of PCE for the following industrial and commercial uses: • As a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing; • In specialty DOD uses (oil analysis and water pipe repair); • In solvent-based paints and coatings; • As solvent for aerosol spray degreaser/cleaner; • As solvent for cold cleaning; • In other textile processing; • In wood furniture manufacturing; • As a solvent for aerosol lubricants; • In wipe cleaning; • In other spot cleaning and spot removers, including carpet cleaning; • In automotive care products (e.g., engine degreaser and brake cleaner); • In non-aerosol cleaner; • In metal (e.g., stainless steel) and stone polishes; • In foundry applications; • In welding; • For mold release; • As a solvent for penetrating lubricants and cutting tool coolants; • For photographic film; • In inks and ink removal products (based on printing); • In inks and ink removal products (based on photocopying); and • In metal mold cleaning, release and protectant products. EPA is also proposing to prohibit the following condition of use, which is the upstream processing condition of use for some of the prohibited industrial and commercial uses: processing into VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 formulation, mixture or reaction product in other chemical products and preparations. EPA is also proposing to phase out the use of PCE at industrial and commercial dry cleaning facilities as described in Unit IV.A.1.c. EPA has considered the sensitive nature of the DOD applications for which EPA received monitoring data for the 2020 Risk Evaluation for PCE, including for the industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair). The Agency understands that DOD has no current data that indicate PCE is required for these specialty uses and EPA has not identified any other entities using PCE in this way. Because there are no known entities engaged in this condition of use, EPA believes a prohibition is reasonable and would prevent any future entities from engaging in this use. EPA is therefore proposing to prohibit the manufacturing, processing, distribution in commerce, and use of PCE for the industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair). As discussed in Units III.B.3. and V.A., based on consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad range of work environments and activities, and the irreversible health effects associated with PCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk from PCE driven in part by the conditions of use identified in this unit. As noted in Unit III.B.1.f., this proposal does not apply to any substance excluded from the definition of ‘‘chemical substance’’ under TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the impacts, if any, a prohibition on the processing of PCE into a formulation, mixture or reaction product in other chemical products and preparations, or other aspects of this proposal, may have on the production and availability of any pesticide or other substance excluded from the TSCA definition of ‘‘chemical substance.’’ EPA is proposing to stagger the compliance dates for the proposed prohibitions described in this unit, such that the requirements would come into effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users after the publication date of the final rule. When PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 39669 proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with PCE exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. However, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes; comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation. EPA also requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. Additionally, EPA recognizes that there may be instances where an ongoing use of PCE that has implications for national security or critical infrastructure as it relates to other Federal agencies (e.g., DOD, NASA) is identified after the PCE rule is finalized, but the final rule prohibits that use. For instances like that, EPA requests comments on an appropriate, predictable, process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued using the tools available under TSCA, aligning with the requirements of section 6(g). One example of an approach could be the establishment by rulemaking of a Federal agency category of use that would require implementation of the WCPP and periodic reporting to EPA on details of the use as well as progress in discontinuing the use or finding a suitable alternative. To utilize the category of use a Federal agency would petition EPA, supported by documentation describing the specific use (including documentation of the specific need, service life of any relevant equipment, and specific identification of any applicable regulatory requirements or E:\FR\FM\16JNP3.SGM 16JNP3 39670 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 certifications, as well as the location and quantity of the chemical being used); the implications of cessation of this use for national security or critical infrastructure (including how the specific use would prevent injuries/ fatalities or otherwise provide lifesupporting functions); exposure control plan; and, for Federal agency uses where similar adoption by the commercial sector may be likely, concrete steps taken to identify, test, and qualify substitutes for the uses (including details on the substitutes tested and the specific certifications that would require updating; and estimates of the time required to identify, test, and qualify substitutes with supporting documentation). EPA requests comment on whether these are the appropriate types of information for use in evaluating this type of category of use, and whether there are other considerations that should apply. EPA would make a decision on the petition within 30 days and publish the decision in the Federal Register shortly after. Additionally, during the year following the petition, EPA would take public comment on the approved petition and no later than 180 days after submitting the petition to EPA, the requesting agency would submit monitoring data indicating compliance with the WCPP at each relevant location as well as documentation of efforts to identify or qualify substitutes. In the absence of that confirmatory data, the utilization of the generic Federal agency category of use would expire within one year of the date of receipt by EPA of the petition. EPA could undertake a section 6(g) rulemaking for those instances where the Federal agency could not demonstrate compliance with the WCPP. This is just one example of a potential process. EPA requests comments on a process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued. b. Prohibition of Manufacturing, Processing and Distribution in Commerce of PCE for Consumer Use In the 2020 Risk Evaluation for PCE, EPA evaluated consumer use of PCE: • In cleaners and degreasers (other); • In automotive care products (brake cleaner); • In automotive care products (parts cleaner); • In aerosol cleaner (vandalism mark and stain remover); • In non-aerosol cleaner (e.g., marble and stone polish); • In lubricants and greases (cutting fluid); VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 • In lubricants and greases (lubricants and penetrating oils); • In adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant); • In adhesives for arts and crafts (livestock grooming adhesive); • In adhesives for arts and crafts (column adhesive, caulk and sealant); • In solvent-based paints and coatings (outdoor water shield (liquid)); • In solvent-based paints and coatings (coatings and primers (aerosol)); • In solvent-based paints and coatings (rust primer and sealant (liquid)); • In solvent-based paints and coatings (metallic overglaze); • In metal (e.g., stainless steel) and stone polishes; • In inks and ink removal products; • In welding; and • In metal mold cleaning, release and protectant products. The consumer uses evaluated in the 2020 Risk Evaluation for PCE constitute all known, intended, and reasonably foreseen consumer uses of PCE. EPA determined that all of these consumer uses drive unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, ‘‘consumer use’’ refers to all consumer uses, including all known, intended, and reasonably foreseen consumer uses of PCE. EPA is proposing to prohibit the manufacturing, processing, and distribution in commerce of PCE for all consumer use. EPA is proposing to phase out consumer use in dry cleaning solvent (i.e., exposure to clothing or articles recently dry cleaned with PCE as described in Unit III.B.1.d.ii.) by phasing out the use of PCE at industrial and commercial dry cleaning facilities as described in Unit IV.A.1.c.; thus, consumer use of clothing and articles that have been commercially dry cleaned with PCE would not be subject to the prohibitions and compliance timeframes described in this unit. As discussed in Units III.B.3. and V.A., based on consideration of the severity of the hazards of PCE in conjunction with the limited options available to adequately address the identified unreasonable risk to consumers and bystanders under TSCA section 6(a), EPA is proposing to address the unreasonable risk from consumer use by prohibiting the manufacturing (including import), processing, and distribution in commerce of PCE for consumer use in order to remove PCE and products containing PCE from the market, thereby effectively eliminating instances of consumer use. PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 Additionally, EPA is proposing to prohibit retailers from distributing in commerce PCE, including any PCEcontaining products, in order to prevent products intended for industrial and commercial use under the WCPP outlined in Unit IV.A.2. from being purchased by consumers. A retailer is any person or business entity that distributes or makes available products to consumers, including through ecommerce internet sales or distribution. If a person or business entity distributes or makes available any product to at least one consumer, then it is considered a retailer (as EPA proposes to define that term in 40 CFR 751.5). For a distributor not to be considered a retailer, the distributor must distribute or make available chemical substances solely to commercial or industrial endusers or businesses. Prohibiting manufacturers (including importers), processors, and distributors from distributing PCE, or any products containing PCE, to retailers would prevent retailers from making these products available to consumers, which would help address that part of the unreasonable risk driven by consumer use of PCE. EPA is proposing that the prohibition described in this unit would take effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, and 21 months for all other distributors (including retailers) after the publication date of the final rule in the Federal Register. EPA considered irreversible health effects and risks associated with PCE exposure when proposing compliance dates. EPA has no reasonably available information indicating these proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. However, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. c. Prohibition and Phaseout of PCE in Dry Cleaning EPA is proposing to prohibit the manufacturing, processing, distribution in commerce, and industrial and commercial use of PCE for dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry machines with refrigerated condenser) and 4th/5th generation (dry-to-dry machines with refrigerated condenser and carbon adsorber process controls) machines. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules As discussed in Units III.B.3. and V.A., based on a consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad range of work environments and activities, and the irreversible health effects associated with PCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk. A prohibition on the manufacturing, processing, distribution in commerce, and industrial and commercial use of PCE in dry cleaning and spot cleaning would address the unreasonable risk for the following conditions of use evaluated in the 2020 Risk Evaluation and described further in Unit III.B.1: • Industrial and commercial use in dry cleaning and spot cleaning post2006 dry cleaning; • Industrial and commercial use in dry cleaning and spot cleaning 4th/5th generation only dry cleaning; and • Consumer use in dry cleaning solvent (i.e., exposure to clothing or articles recently dry cleaned with PCE). EPA recognizes that the transition to an alternative dry cleaning process or solvent could require significant time and investment from dry cleaning facilities; therefore, EPA is proposing a phaseout period to take place following the publication date of the final rule. The phaseout would start with a prohibition on the use of PCE in any dry cleaning machine acquired 6 months or later after the publication date of the rule, followed by a prohibition on the use of PCE in 3rd generation machines 3 years after the publication date of the rule. Full implementation of the phaseout would be achieved with a prohibition on the use of PCE in all dry cleaning and spot cleaning, including in 4th and 5th generation machines, 10 years after the publication date of the final rule and a prohibition on the manufacturing, processing, and distribution in commerce of PCE for use in dry cleaning solvent 10 years after the publication date of the final rule. When proposing these compliance dates, EPA considered reasonably available information, including market research, existing State actions restricting the use of PCE in dry cleaning (Title 17, California Code of Regulations 39109 and 93110; Minnesota HF 91; 6 NYCRR Part 232), and engagement with industry, trade associations, and State and local agencies. Based on this reasonably available information, EPA understands that the use of PCE in dry cleaning is currently declining and that very few PCE machines are being produced or sold in the U.S. market VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 (Ref. 33). As described more fully in the Economic Analysis (Ref. 3), EPA assumes dry cleaning machines are retired 15 to 25 years after the manufactured date. Therefore, EPA assumes most dry cleaning machines manufactured and installed before 2005, such as for 3rd generation machines, would be beyond their projected useful life by the proposed phaseout dates outlined in this Unit. A 3-year phaseout of the use of PCE in 3rd generation dry cleaning machines takes into consideration the age of existing 3rd generation dry cleaning machines as well as public comments submitted on the proposed amendments to the PCE Dry Cleaning NESHAP (December 27, 2021, 86 FR 73207) recommending a 3to 5-year compliance timeframe at minimum to account for supply issues related to those machines. A 10-year phaseout of the use of PCE in dry cleaning and spot cleaning takes into account that, while the average projected useful lifespan of dry cleaning machines is 15 to 25 years, the purchase of new PCE dry cleaning machines has been in decline. As described more fully in the Economic Analysis, EPA estimates that 6,000 dry cleaners still use PCE and estimates that about 60 machines are expected to still be in use at the end of the 10-year phaseout period given the declining trend of use and age of machines. EPA believes that the proposed 6-month and 3-year compliance dates for the start of the phaseout, and the proposed 10-year compliance date for full implementation of the phaseout, are consistent with requirements in TSCA section 6(d)(1)(C) and (D), respectively, to specify mandatory compliance dates for the start of phaseout requirements that are as soon as practicable but not later than 5 years after the date of promulgation of the rule, and to specify mandatory compliance dates for full implementation of phaseout requirements that are as soon as practicable. EPA also believes that these compliance dates provide for a reasonable transition period, consistent with TSCA section 6(d)(1)(E). EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited. However, EPA requests comment on the amount of time needed, for example, for dry cleaners to transition to an alternative process or solvent. EPA also requests comment regarding the number of entities that could potentially close as well as associated costs with a 10-year phaseout of PCE for use in dry cleaning as identified in this unit. EPA may PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 39671 finalize significantly shorter or longer compliance timeframes based on consideration of public comments. d. De Minimis Level To aid the regulated community with implementing the prohibitions, and to account for de minimis levels of PCE as an impurity in products, EPA is proposing that products containing PCE at concentrations less than 0.1% by weight are not subject to the prohibitions described in this unit. EPA has determined that the prohibitions are only necessary for products containing PCE at levels equal to or greater than 0.1% by weight in order to eliminate the unreasonable risk of injury resulting from inhalation and dermal exposures from PCE-containing products during occupational and consumer conditions of use. EPA’s description for how allowing for a concentration of PCE up to 0.1% would address the unreasonable risk associated with PCE-containing products and rationale for this regulatory approach are in Unit V.A. EPA requests comment on allowing this de minimis level of PCE in products to account for impurities. 2. Workplace Chemical Protection Program (WCPP) a. Overview As described in Unit III.B.3., under TSCA section 6(a), EPA is required to issue a regulation applying one or more of the TSCA section 6(a) requirements to the extent necessary so that the unreasonable risk of injury to health or the environment from a chemical substance is no longer presented. The TSCA section 6(a) requirements provide EPA the authority to limit or restrict a number of activities, alone or in combination, including the manufacture, processing, distribution in commerce, commercial use, and disposal of the chemical substance. Given this authority, EPA may find it appropriate in certain circumstances to propose requirements under a WCPP for certain occupational (i.e., manufacturing, processing, industrial and commercial use, and disposal) conditions of use. A WCPP for PCE would encompass the inhalation exposure limit and action level, Direct Dermal Contact Control (DDCC) requirements, and the associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk. Under a WCPP, owners or operators would have some flexibility, within the parameters outlined in this unit, regarding how they prevent exceedances of the E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39672 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules identified EPA exposure limit thresholds or prevent direct dermal contact. In the case of PCE, meeting the EPA exposure limits and implementing the DDCC requirements for certain occupational conditions of use would address unreasonable risk to potentially exposed persons from inhalation and dermal exposure. EPA uses the term ‘‘potentially exposed person’’ in this unit and in the regulatory text to include workers, ONUs, employees, independent contractors, employers and all other persons in the work area where PCE is present and who may be exposed to PCE under the conditions of use for which a WCPP would apply. EPA’s intention is to require a comprehensive WCPP that would address the unreasonable risk from PCE to potentially exposed persons directly handling the chemical or in the area where the chemical is being used. Similarly, the 2020 risk evaluation for PCE did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of PCE. EPA uses the term ‘‘owner or operator’’ to describe the entity responsible for implementing the WCPP for workplaces where an applicable condition of use is occurring and PCE is present. The term includes any person who owns, leases, operates, controls, or supervises such a workplace. An ECEL is a risk-based inhalation exposure threshold. The ECEL would be accompanied by monitoring, training, recordkeeping and other requirements to help ensure that the threshold is not exceeded. With an ECEL, regulated entities have some flexibility, within certain parameters outlined in this unit, for preventing exceedances of the identified exposure threshold. Therefore, EPA generally refers to the ECEL and ancillary requirements as a non-prescriptive approach. In the case of PCE, the exposure threshold identified by EPA for certain occupational conditions of use would mitigate unreasonable risk from inhalation exposure driven by those conditions of use for potentially exposed persons. DDCC requirements are process-based approaches to prevent direct dermal contact with PCE and associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk from dermal exposure. As with the ECEL, DDCC requirements allow regulated entities some flexibility within certain parameters outlined in this unit for preventing direct dermal contact with VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 PCE. In the case of PCE, EPA has preliminarily determined that preventing direct dermal contact through DDCC requirements for certain conditions of use would mitigate unreasonable risk from dermal exposure driven by those conditions of use for potentially exposed persons. This unit includes a summary of the proposed PCE WCPP, including a description of the ECEL; proposed implementation requirements and an EPA ECEL action level; proposed monitoring requirements; a description of potential exposure controls, which consider the hierarchy of controls; information that may be used to inform respirator selection; and additional requirements proposed for recordkeeping, and worker training, participation, and notification. This unit also describes proposed DDCC requirements for PCE, including potential exposure controls, which consider the hierarchy of controls; proposed PPE as it relates to dermal protection; and additional requirements proposed for recordkeeping. This unit also describes compliance timeframes for these proposed requirements. b. Existing Chemical Exposure Limit (ECEL) i. ECEL and ECEL action level. To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from inhalation exposures to PCE identified under the occupational conditions of use in the TSCA 2020 Risk Evaluation for PCE, EPA is proposing an ECEL of 0.14 parts per million (ppm) (0.98 mg/m3) for inhalation exposures to PCE as an 8hour TWA. This ECEL is based on the occupational chronic, non-cancer human equivalent concentration (HEC) for neurotoxicity (Ref. 10). EPA has determined, as a matter of risk management policy, that ensuring exposures remain at or below the ECEL would eliminate the contribution to the unreasonable risk of injury to health for PCE resulting from inhalation exposures in an occupational setting. EPA is proposing to establish requirements to meet an ECEL as part of the WCPP for: • Manufacturing (domestic manufacturing); • Manufacturing (import); • Processing as a reactant/ intermediate; • Processing into formulation, mixture, or reaction product in cleaning and degreasing products; • Processing into formulation, mixture, or reaction products in paint and coating products; PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 • Processing into formulation, mixture, or reaction products in adhesive and sealant products; • Processing by repackaging; • Industrial and commercial use as solvent for open-top batch vapor degreasing; • Industrial and commercial use as solvent for closed-loop batch vapor degreasing; • Industrial and commercial use as solvent for in-line conveyorized vapor degreasing; • Industrial and commercial use as solvent for in-line web cleaner vapor degreasing; • Industrial and commercial use in maskant for chemical milling; • Industrial and commercial use in solvent-based adhesives and sealants; and • Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing. Each owner or operator of a workplace where these conditions of use occur would be responsible for compliance with the ECEL and the associated requirements. EPA’s description for how the requirements related to an ECEL would address the unreasonable risk resulting from inhalation exposures and the rationale for this regulatory approach are outlined in Units III.B.3. and V.A. If ambient exposures are kept at or below the 8-hour ECEL of 0.14 ppm, EPA expects that a potentially exposed person in the workplace would be protected against non-cancer effects resulting from occupational exposures, as well as excess risk of cancer (Ref. 10). EPA is also proposing to establish an ECEL action level of 0.07 ppm as an 8hour TWA for PCE. Air concentrations at or above the action level would trigger more frequent periodic monitoring of exposures to PCE, as described in this unit. EPA is proposing to adopt the action level approach in implementing the TSCA ECEL, consistent with the action level approach utilized by OSHA in the implementation of OSHA standards, although the values differ due to differing statutory authorities. As explained by OSHA, due to the variable nature of employee exposures, compliance with an action level provides employers with greater assurance that their employees will not be exposed to concentrations above the PELs (Ref. 42). EPA agrees with this reasoning and, like OSHA, expects the inclusion of an ECEL action level will stimulate innovation within industry to reduce exposures to levels below the action level. Therefore, EPA has identified a need for an action level for E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules PCE and is proposing a level that would be half the 8-hour ECEL, which is in alignment with the precedented approach established under most OSHA standards. EPA is soliciting 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. In summary, EPA is proposing that each owner or operator of a workplace subject to the ECEL must ensure that no person is exposed to airborne concentration of PCE in excess of 0.14 ppm (0.98 mg/m3) as an 8-hour TWA (ECEL), with an action level identified as 0.07 ppm (0.47 mg/m3) (ECEL action level). For conditions of use for which the requirements to meet an ECEL are being proposed, EPA expects that the regulated community can detect the ECEL and ECEL action level as they are above the threshold of PCE air sampling analytical methods that are widely available in commerce, currently in use, and approved by OSHA and NIOSH, which can range from ≤0.5 parts per billion (ppb) to 9 ppm (Ref. 10). The Agency has also identified personal breathing zone air sampling devices with a minimum limit of quantitation and level of detection below the ECEL action level (Ref. 43). EPA is requesting comment on issues around the viability of current analytical methods and detection limits for occupational perchloroethylene sampling and/or monitoring methods. EPA’s methodology and inputs for the ECEL value are directly derived from the peer reviewed analysis in the December 2020 Risk Evaluation, which was also subject to public comment. As with all aspects of this rulemaking, the public is welcome to comment on the methodology for the ECEL value. 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 PCE air concentration levels to near or below the ECEL. As discussed further in Unit V.A.1., for some conditions of use for which EPA is proposing the ECEL, data were submitted during the risk evaluation that indicate inhalation exposures may already be near or below the ECEL for some facilities, indicating that such facilities may already be in compliance with the proposed ECEL. As noted previously in this unit, EPA expects that, if inhalation exposures for affected occupational conditions of use are kept at or below the ECEL, potentially exposed persons reasonably likely to be exposed in the workplace would be protected from the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 unreasonable risk. EPA is also proposing to require owners or operators to comply with additional requirements under the WCPP that would be needed to ensure successful implementation of the ECEL. ii. Monitoring requirements. Overview. Monitoring requirements are a key component of implementing EPA’s proposed WCPP. Initial monitoring for PCE is critical for establishing a baseline of exposure for potentially exposed persons; similarly, periodic exposure monitoring assures continued compliance so that potentially exposed persons in the workplace are not exposed to levels that would result in an unreasonable risk of injury. Periodic exposure monitoring frequency could change if certain conditions are met, which are described in this unit. Additionally, in some cases, a change in workplace conditions with the potential to impact exposure levels would warrant additional monitoring, which is also described. To ensure compliance with monitoring activities, EPA proposes exposure monitoring recordkeeping requirements outlined in this unit. Initial exposure monitoring. Under the proposed regulation, each owner or operator of a workplace where any condition of use listed earlier in this unit is occurring would be required to perform initial exposure monitoring to determine the extent of exposure of potentially exposed persons to PCE. Initial monitoring would notify owner or operators of the magnitude of possible exposures to their potentially exposed persons with respect to their unique work conditions and environments. The results of the initial exposure monitoring would determine the frequency of future periodic monitoring, whether additional exposure controls are necessary (such as engineering controls, administrative controls, and/or respiratory protection), and whether the owner or operator would need to demarcate a regulated area as described in this unit. EPA is proposing to require each owner or operator to establish an initial baseline monitoring sample to determine the magnitude of exposure for all persons who may be exposed to PCE within 6 months after the date of publication of the final rule in the Federal Register or within 30 days of introduction of PCE into the workplace, whichever is later. Where PCE is present in the workplace, each owner or operator would be required to determine each potentially exposed person’s exposure by either taking a personal breathing zone air sample of each potentially exposed person or taking PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 39673 personal breathing zone air samples that are representative of each potentially exposed person’s exposure performing the same or substantially similar operations in each work shift, in each job classification, and in each work area (hereinafter identified as an ‘‘exposure group’’). Representative 8-hour TWA exposures must be determined based on one or more samples representing fullshift exposures for each shift for each person in each job classification in each work area. Monitoring samples must be taken when and where the operating conditions are best representative of each potentially exposed person’s fullshift exposures. EPA expects that owners and operators would attempt to monitor a baseline for all of the tasks during the same timeframe; however, EPA understands that certain tasks occur less frequently, and EPA is soliciting comments regarding the timing of the initial exposure monitoring so that it would be representative of all tasks involving PCE where exposures may approach the ECEL. If the owner or operator chooses a representative sample, such sampling must include persons that are the closest to the source of PCE, so that the monitoring results are representative of the most highly exposed persons in the workplace. EPA is also soliciting comments regarding use of area sampling instead of personal breathing zone as a representative sample of exposures. EPA also recognizes that some entities may already have exposure monitoring data. If the owner or operator has monitoring data conducted within five years prior to the effective date of the final rule and the monitoring satisfies all other requirements of this section, including the requirement that the data represents the highest PCE exposures likely to occur under reasonably foreseeable conditions of use, the owner or operator may rely on such earlier monitoring results for the initial baseline monitoring sample. Periodic exposure monitoring. EPA is proposing to require each owner or operator to conduct, for those exposure groups that exceed the following airborne concentration levels, the following periodic monitoring: • If all samples taken during the initial exposure monitoring reveal a concentration below the ECEL action level (<0.07 ppm 8-hour TWA), the owner or operator must repeat the periodic exposure monitoring at least once every five years. • If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA), the owner or operator E:\FR\FM\16JNP3.SGM 16JNP3 39674 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules must repeat the periodic exposure monitoring within 3 months of the most recent exposure monitoring. • If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level (≥0.07 ppm 8-hour TWA) but at or below the ECEL (≤0.14 ppm 8-hour TWA), the owner or operator must repeat the periodic exposure monitoring within 6 months of the most recent exposure monitoring. • If the most recent (non-initial) exposure monitoring indicates that airborne exposure is below the ECEL action level, the owners or operators must repeat such monitoring within 6 months of the most recent monitoring until two consecutive monitoring measurements, taken at least seven days apart, are below the ECEL action level (<0.07 ppm 8-hour TWA), at which time the owner or operator must repeat the periodic exposure monitoring at least once every 5 years. Additionally, in instances where an owner or operator does not manufacture, process, use, or dispose of PCE for a condition of use for which the WCPP is proposed over the entirety of time since the last required periodic monitoring event, EPA is proposing that the owner or operator would be permitted to forgo the next periodic monitoring event. However, documentation of cessation of use of PCE would be required and periodic monitoring would be required to resume should the owner or operator restart any of the conditions of use listed in unit IV.A.2. for which the WCPP is proposed. The proposed periodic monitoring requirements are also outlined in Table 1. EPA requests comment on the timeframes for periodic monitoring outlined in this unit. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. ddrumheller on DSK120RN23PROD with PROPOSALS3 TABLE 1—PERIODIC MONITORING REQUIREMENTS Air concentration condition Periodic monitoring requirement If all initial exposure monitoring is below the ECEL action level ............. (<0.07 ppm 8-hour TWA) ......................................................................... If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA). If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level but at or below the ECEL (≥0.07 ppm 8-hour TWA, ≤0.14 ppm 8-hour TWA). If the two most recent (non-initial) exposure monitoring measurements, taken at least seven days apart within a 6 month period, indicate exposure is below the ECEL action level (<0.07 ppm 8-hour TWA). If the owner or operator engages in a condition of use for which WCPP ECEL would be required but does not manufacture, process, use, or dispose of PCE in that condition of use over the entirety of time since the last required monitoring event. Periodic exposure monitoring is required at least once every five years. Additional exposure monitoring. In addition to the initial and periodic exposure monitoring, EPA is proposing that each owner or operator conduct additional exposure monitoring whenever a change in the production, process, control equipment, personnel, or work practices may reasonably be expected to result in new or additional exposures at or above the ECEL action level, or when the owner or operator has any reason to believe that new or additional exposures at or above the ECEL action level have occurred. In the event of start-up, shutdown, spills, leaks, ruptures or other breakdowns that may lead to employee exposure, EPA is proposing that each owner or operator must conduct additional initial exposure monitoring to potentially exposed persons (using personal breathing zone sampling) after the cleanup of the spill or repair of the leak, rupture or other breakdown. An additional exposure monitoring event may result in an increased frequency of periodic monitoring. For example, if the initial monitoring results from a workplace are above the ECEL action level, but below the ECEL, periodic monitoring is required every 6 months. If additional monitoring is performed VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 Periodic exposure monitoring is required within 3 months of the most recent exposure monitoring. Periodic exposure monitoring is required within 6 months of the most recent exposure monitoring. Periodic exposure monitoring is required within 5 years of the most recent exposure monitoring. The owner or operator may forgo the next periodic monitoring event. However, documentation of cessation of use of PCE is required and periodic monitoring would be required when the owner or operator resumes the condition of use. because increased exposures are suspected, and the results are above the ECEL, subsequent periodic monitoring would have to be performed every 3 months. The required additional exposure monitoring should not delay implementation of any necessary cleanup or other remedial action to reduce the exposures to persons in the workplace. Other monitoring requirements. For each monitoring event, EPA is proposing to require owners or operators ensure that their methods be accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of PCE. Also, EPA is proposing to require use of appropriate sampling and analytical methods used to determine PCE exposure, including as relevant: (A) Use of an analytical method already approved by EPA, OSHA or NIOSH, or another analytical method that has been demonstrated to meet the proposed accuracy requirement at an appropriate level of detection for the ECEL and ECEL action level; (B) Compliance with the Good Laboratory Practice Standards at 40 CFR part 792. Additionally, EPA is proposing to require owners and operators to re-monitor within 15 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 working days after receipt of the results of any exposure monitoring when results indicate 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 remonitoring is not necessary. EPA is also proposing to require that each owner or operator maintain exposure monitoring records that include the following information for each monitoring event: (A) Dates, duration, and results of each sample taken; (B) All measurements that may be necessary to determine the conditions (e.g., work site temperatures, humidity, ventilation rates, monitoring equipment type and calibration dates) that may affect the monitoring results. (C) Name, workplace address, work shift, job classification, and work area of the person monitored; documentation of all potentially exposed persons whose exposures the monitoring is intended to represent if using a representative sample; and type of respiratory protective device worn by the monitored person, if any. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules (D) Use of appropriate sampling and analytical methods, such as analytical methods already approved by EPA, OSHA or NIOSH, or compliance with an analytical method verification procedure. (E) Compliance with the Good Laboratory Practice Standards at 40 CFR part 792. (F) Information regarding air monitoring equipment, including: type, maintenance, calibrations, performance tests, limits of detection, and any malfunctions. iii. Incorporation of the hierarchy of controls. EPA is proposing to require owners or operators to implement the WCPP in accordance with the hierarchy of controls and encourages the use of pollution prevention to control exposures whenever practicable. Pollution prevention, also known as source reduction, is any practice that reduces, eliminates, or prevents pollution at its source (e.g., elimination and substitution). Similarly, the hierarchy of controls includes, in order of preference, elimination, substitution, engineering controls, and administrative controls, prior to relying on PPE as a means of controlling exposures (Ref. 8). EPA is proposing to require owners or operators to reduce inhalation exposures below the ECEL in accordance with the hierarchy of controls. EPA expects that, for conditions of use for which EPA is proposing a WCPP, compliance at most workplaces would be part of an existing industrial hygiene program. Workplaces that cannot feasibly eliminate the source of PCE emissions or replace PCE with a substitute would have to use engineering and/or administrative controls to implement process changes to reduce exposures to the extent feasible, following the hierarchy of controls (Ref. 8). If an owner or operator chooses to replace PCE with a substitute, EPA recommends that they carefully review the available hazard and exposure information on the potential substitutes to avoid a substitute chemical that might later be found to present unreasonable risks or be subject to regulation (sometimes referred to as a ‘‘regrettable substitution’’). If an effort to identify and implement feasible exposure controls such as elimination, substitution, engineering controls, and administrative controls are not sufficient to reduce exposures to or below the ECEL for all persons in the workplace, EPA proposes to require each owner or operator to use such controls to reduce PCE concentrations in the workplace to the lowest levels achievable and, only after levels cannot VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 be further reduced, supplement these controls using respiratory protection before persons are permitted to enter a regulated area, as described in this unit. In such cases, EPA would require that the owner or operator provide those persons exposed or who may be exposed to PCE by inhalation above the ECEL with respirators sufficient to ensure that their exposures do not exceed the ECEL, as described in this unit. EPA also proposes to require that each owner or operator document their evaluation of elimination, substitution, engineering and administrative exposure control strategies, and if applicable the reasons why they found these strategies infeasible to control exposures below the ECEL, in an exposure control plan as described in this unit. In addition, a regulated entity would be prohibited from rotating work schedules of potentially exposed persons to comply with the ECEL 8-hour TWA. EPA may require more, less, or different documentation regarding exposure control strategies in the final rule based on consideration of public comments. iv. Regulated area. Based on the exposure monitoring, EPA is proposing to require that owners or operators of workplaces subject to a WCPP demarcate any area where airborne concentrations of PCE exceed or are reasonably expected to exceed the ECEL. Regulated areas would be demarcated using administrative controls, such as warning signs or highly visible signifiers, in multiple languages as appropriate (e.g., based on languages spoken by potentially exposed persons), placed in conspicuous areas, and documented through training and recordkeeping. The owner or operator would be required to restrict access to the regulated area from any potentially exposed person that lacks proper training, is not wearing required PPE as described in this unit or is otherwise unauthorized to enter. EPA is proposing to require owners and operators demarcate a regulated area beginning 9 months after the date of publication of the final rule, or within 3 months after receipt of any exposure monitoring that indicates exposures exceeding the ECEL. EPA is soliciting comment on requiring warning signs to demarcate regulated areas, such as the requirements found in OSHA’s General Industry Standard for Beryllium (29 CFR 1910.1024(m)(2)). v. Notification of monitoring results. EPA proposes that the owner or operator must, within 15 working days after receipt of the results of any exposure monitoring, notify each person whose exposure is represented by that PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 39675 monitoring in writing, either individually to each potentially exposed person or by posting the information in an appropriate and accessible location accessible to all persons whose exposure is represented by the monitoring, such as public spaces or common areas, outside the regulated area. This notice must include the exposure monitoring results, identification and explanation of the ECEL and ECEL action level in plain language, any corresponding required respiratory protection, if applicable, the quantity, location, manner of PCE use and identified releases of PCE that could result in exposure to PCE, and whether the airborne concentration of PCE exceeds the ECEL limit. The notice must also include a description of actions taken by the owner or operator to reduce inhalation exposures to or below the ECEL, if applicable, or refer to a document available to the potentially exposed persons which states the actions to be taken to reduce exposures, and be posted in multiple languages if necessary (e.g., notice must be in a language that the potentially exposed person understands, including a nonEnglish language version representing the language of the largest group of workers who cannot readily comprehend or read English). c. Direct Dermal Contact Control Requirements i. Direct dermal contact. DDCC requirements are a process-based set of provisions to address unreasonable risk driven by dermal exposure by preventing direct dermal contact in the workplace. In order to address the unreasonable risk driven by dermal exposure to PCE, DDCC requirements would include controls to separate, distance, physically remove, or isolate all person(s) from direct handling of PCE or from skin contact with surfaces that may be contaminated with PCE (i.e., equipment or materials on which PCE may be present) under routine conditions in the workplace (hereafter referred to as direct dermal contact). For purposes of DDCC requirements, direct dermal contact with PCE does not include vapor exposures through the skin, although EPA recommends and encourages owners and operators to implement control measures to prevent or reduce dermal exposures to airborne PCE vapors. The 2020 Risk Evaluation for PCE identified that unreasonable risk to workers is also driven by the dermal exposure, specifically from direct skin contact with PCE; risk exceeding the benchmark was identified even when considering use of chemically resistant gloves in most commercial and E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39676 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules industrial conditions of use. EPA’s description for how the requirements related to DDCC would address the unreasonable risk resulting from dermal exposures and the rationale for this regulatory approach is outlined in Units III.B.3. and V.A. Similar to the ECEL, under DDCC requirements, EPA is proposing to require owners and operators implement dermal exposure controls in accordance with the hierarchy of controls. EPA also recommends and encourages the use of pollution prevention as a means of controlling exposures whenever practicable. In addition to the conditions of use for which EPA is proposing to require a WCPP ECEL, EPA is also proposing WCPP DDCC requirements for the following conditions of use: recycling and disposal. Within certain parameters outlined in this unit, DDCC requirements are nonprescriptive to allow more flexibility to owners and operators to choose their controls to prevent direct dermal contact when compared with prescriptive requirements for specific controls. Each owner or operator of a workplace engaging in a condition of use for which DDCC requirements are proposed would be responsible for compliance with the DDCC requirements and recordkeeping. As discussed briefly in Unit IV.A.1. and further in Unit V.A.1., EPA expects that many workplaces already have stringent controls in place that reduce dermal exposures to PCE; for some workplaces, EPA understands that these existing controls may already prevent or reduce direct dermal contact with PCE. ii. Incorporation of the hierarchy of controls. As with the requirements to meet an ECEL, EPA is proposing to require owners or operators to implement DDCC requirements in accordance with the hierarchy of controls and encourages the use of pollution prevention to control exposures whenever practicable. EPA recognizes that some owners or operators may have industrial hygiene practices already preventing direct dermal contact with PCE in the workplace. For workplaces that cannot feasibly eliminate the source of PCE dermal exposure or replace PCE with a substitute, workplaces would have to use engineering and/or administrative controls to implement process changes to prevent direct dermal contact with PCE to the extent feasible. If an owner or operator chooses to replace PCE with a substitute, EPA recommends that they carefully review the available hazard and exposure information on the potential substitutes to avoid a VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 regrettable substitution. If an effort to identify and implement feasible exposure controls such as elimination, substitution, engineering controls and administrative controls is not sufficient to prevent direct dermal contact with PCE for potentially exposed persons in the workplace, EPA proposes to require each owner and operator to reduce potential for direct dermal contact with PCE in the workplace by these controls and to supplement these controls using PPE. Examples of engineering controls that may prevent or reduce the potential for direct dermal contact include automation, physical barriers between contaminated and clean work areas, enclosed transfer liquid lines (with purging mechanisms in place (e.g., nitrogen, aqueous) for operations such as product changes or cleaning), and design of tools (e.g., a closed-loop container system providing contact-free connection for unloading fresh and collecting spent solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples of administrative controls that may prevent or reduce the potential for direct dermal contact include adjusting work practices (i.e., implementing policies and procedures) such as providing safe working distances from areas where direct handling of PCE may occur. EPA requests comment on available methods to measure the effectiveness of engineering and administrative controls in preventing or reducing the potential for direct dermal contact to PCE. EPA is also requesting comment on available monitoring methods, such as charcoal patch testing, as feasible or effective methods to measure potential direct dermal contact with PCE. EPA proposes to require that owners and operators document their implementation efforts and compliance with DDCC requirements in an exposure control plan or through any existing documentation of the facility’s ‘‘Safety and Health Program’’ that may already be developed as part of meeting OSHA requirements or other safety and health standards (Ref. 44), as described in Unit IV.A.2.e. d. Personal Protective Equipment (PPE) Program Where elimination, substitution, engineering controls, and administrative controls are not feasible to reduce the air concentration to or below the ECEL and/or prevent direct dermal contact with PCE for all potentially exposed persons, EPA is proposing to require implementation of a PPE program in alignment with OSHA’s General Requirements for Personal Protective PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 Equipment at 29 CFR 1910.132. Consistent with 29 CFR 1910.132, owners and operators would be required to provide PPE, including respiratory protection and dermal protection selected in accordance with the guidelines described in this unit, that is of safe design and construction for the work to be performed. EPA is proposing to require owners and operators ensure each potentially exposed person who is required by this unit to wear PPE to use and maintain PPE in a sanitary, reliable, and undamaged condition. Owners and operators would be required to select and provide PPE that properly fits each potentially exposed person who is required by this unit to use PPE and communicate PPE selections to each affected person. As part of the PPE program, EPA is also proposing that owners and operators must comply with OSHA’s general PPE training requirements at 29 CFR 1910.132(f) for application of a PPE training program, including providing training on proper use of PPE (e.g., when and where PPE is necessary, proper application, wear, and removal of PPE, maintenance, useful life and disposal of PPE). EPA is proposing that owners and operators would provide PPE training to each potentially exposed person who is required by this unit to wear PPE prior to or at the time of initial assignment to a job involving potential exposure to PCE. Owners and operators would also have to re-train each affected person at least once annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in the PPE to be used render the previous training obsolete. This unit includes a description of the PPE Program, including proposed PPE as it relates to respiratory protection, proposed PPE as it relates to dermal protection, and other proposed requirements such as additional training for respirators and recordkeeping to support implementation of a PPE program. i. Respiratory protection. Where elimination, substitution, engineering, and administrative controls are not feasible to reduce the air concentration to or below the ECEL, EPA proposes to set minimum respiratory PPE requirements based on an entity’s most recent measured air concentration and the level of PPE that EPA determined would be needed to reduce exposure to the ECEL. In those circumstances, EPA is proposing to require a respiratory protection PPE program with worksitespecific procedures and elements for E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules required respirator use. The respiratory protection PPE program proposed by EPA would be based on the most recent exposure monitoring concentration measured as an 8-hour TWA and would be administered by a suitably trained program administrator. EPA is also proposing to require each owner or operator select respiratory protection in accordance with the guidelines described in this unit and 29 CFR 1910.134(a) through (l), except (d)(1)(iii), for proper respirator use, maintenance, fit-testing, medical evaluation, and training. EPA is not proposing to cross reference 29 CFR 1910.134(d)(1)(iii) because the WCPP contains requirements for identifying PCE respiratory hazards in the workplace. Required Respiratory Protection. EPA is proposing to require each owner or operator supply a respirator, selected in accordance with this unit, to each person who enters a regulated area within 3 months after the receipt of any exposure monitoring that indicates exposures exceeding the ECEL and thereafter must ensure that all persons within the regulated area are using the provided respirators whenever PCE exposures exceed or can reasonably be expected to exceed the ECEL. Given the risks associated with PCE exposure above the ECEL, prompt compliance with the respiratory protection requirements is important, but EPA expects that most owners or operators will need some time after the exposure monitoring results are received to acquire the correct respirators and establish a respiratory protection program, including training, fit-testing, and medical evaluations. EPA believes that 3 months should be sufficient for this purpose. EPA is also proposing that owners or operators who would be required to administer a respiratory protection program must supply a respirator selected in accordance with 29 CFR 1910.134(d)(1) (except (d)(1)(iii)). Additionally, EPA is proposing that the owner or operator must ensure that all filters, cartridges and canisters used in the workplace are labeled and color coded with the NIOSH approval label and that the label is not removed and remains legible. 29 CFR 1910.134(d)(3)(iii), which EPA is proposing to cross-reference, requires either the use of respirators with an endof-life service indicator certified by NIOSH for the contaminant, in this case PCE, or implementation of a change schedule for canisters and cartridges that ensures that they are changed before the end of their service life. EPA is requesting comment on whether there VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA’s General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA’s General Industry Standard for Benzene (29 CFR 1910.1028(g)(3)(D)). EPA is proposing the following requirements for respiratory protection, based on the exposure monitoring concentrations measured as an 8-hour TWA that exceed the ECEL (0.14 ppm). EPA is proposing to establish minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the following proposed requirements may be used. While this unit includes respirator selection requirements for respirators of assigned protection factors (APFs) of 1,000 or greater, EPA does not anticipate that respirators beyond APF 25 will be widely or regularly used to address unreasonable risk, particularly when other controls are put in place. • If the measured exposure concentration is at or below 0.14 ppm: no respiratory protection is required. • If the measured exposure concentration is above 0.14 ppm and less than or equal to 0.7 ppm (5 times ECEL): Any NIOSH-certified airpurifying quarter mask respirator (APF 5). • If the measured exposure concentration is above 0.7 ppm and less than or equal to 1.4 ppm (10 times ECEL): Any NIOSH-certified airpurifying half mask or full facepiece respirator equipped with NIOSHapproved organic vapor cartridges or canisters (APF 10). • If the measured exposure concentration is above 1.4 ppm and less than or equal to 3.5 ppm (25 times ECEL): Any NIOSH-certified airpurifying full facepiece respirator equipped with NIOSH-approved organic vapor cartridges or canisters; any NIOSH-certified powered air-purifying respirator equipped with NIOSHapproved organic vapor cartridges; or any NIOSH-certified continuous flow supplied air respirator equipped with a hood or helmet (APF 25). • If the measured exposure concentration is above 3.5 ppm and less than or equal to 7.0 ppm (50 times ECEL): Any NIOSH-certified airpurifying full facepiece respirator equipped with NIOSH-approved organic vapor cartridges or canisters; or any NIOSH-certified powered air-purifying respirator equipped with a tight-fitting PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 39677 facepiece and a NIOSH-approved organic vapor cartridge (APF 50). • If the measured exposure concentration is above 7.0 ppm and less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH-certified supplied air respirator equipped with a half mask or full facepiece and operated in a pressure demand or other positive pressure mode (APF 1,000). • If the measured exposure concentration is greater than 140 ppm (1,000 times ECEL) or the concentration is unknown: Any NIOSH-certified selfcontained breathing apparatus (SCBA) equipped with a full facepiece and operated in a pressure demand or other positive pressure mode; or any NIOSHcertified supplied air respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode in combination with an auxiliary SCBA operated in a pressure demand or other positive pressure mode (APF 10,000). EPA proposes to require that owners and operators document respiratory protection used and PPE program implementation. EPA proposes to require that owners and operators document in the exposure control plan or other documentation of the facility’s safety and health program information relevant to respiratory program, including records on the name, workplace address, work shift, job classification, work area, and type of respirator worn (if any) by each potentially exposed person, maintenance, and fit-testing, as described in 29 CFR 1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29 CFR 1910.134(k). ii. Dermal protection. Where elimination, substitution, engineering controls, and administrative controls are not feasible or sufficient to fully prevent direct dermal contact with PCE, EPA is proposing to require that appropriate dermal PPE be provided by owners and operators to, and be worn by, persons potentially exposed to direct dermal contact with PCE. To accomplish this, EPA is proposing owners and operators follow the dermal PPE requirements for PPE selection laid out in this unit. Required Dermal Protection. In choosing appropriate dermal PPE, owners and operators would be required to select gloves, clothing, and protective gear (which covers any exposed dermal area of arms, legs, torso, and face) based on specifications from the manufacturer or supplier that demonstrate an impervious barrier to PCE during expected durations of use and normal conditions of exposure within the workplace, accounting for potential chemical permeation or breakthrough E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39678 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules times. In alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138), owners and operators would be required to select dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use. Further information related to choosing appropriate PPE can be found in the summary of suitable gloves for PCE memo (Ref. 45). For example, owners and operators can select gloves that have been tested in accordance with the American Society for Testing and Materials (ASTM) F739 ‘‘Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact.’’ EPA is proposing that PPE be provided for use for a time period only to the extent and no longer than the time period for which testing has demonstrated that the PPE will be impermeable during expected durations of use and conditions of exposure. EPA is proposing to require that owners and operators also consider other factors when selecting appropriate PPE, including effectiveness of glove type when preventing exposures from PCE alone and in likely combination with other chemical substances used in the work area or when used with glove liners, permeation, degree of dexterity required to perform task, and temperature, as identified in the Hand Protection section of OSHA’s Personal Protective Equipment Guidance (Ref. 46). EPA is proposing that owners and operators would be required to establish, either through manufacturer or supplier-provided documentation or individually prepared 3rd party testing that the selected PPE will be impervious for the expected duration and conditions of exposure, such as using the format specified in ASTM F1194– 99(2010) ‘‘Standard Guide for Documenting the Results of Chemical Permeation Testing of Materials Used in Protective Clothing Materials,’’ reporting cumulative permeation rate as a function of time, or equivalent manufacturer- or supplier- provided testing. Owners and operators would also be required to consider likely combinations of chemical substances to which the clothing may be exposed in the work area when selecting the appropriate PPE such that the PPE will prevent direct dermal contact to PCE. EPA is proposing that PPE must be immediately provided and replaced if any person is dermally exposed to PCE longer than the breakthrough time period for which testing has VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 demonstrated that the PPE will be impermeable or if there is a chemical permeation or breakage of the PPE. Additionally, EPA is proposing to require that owners and operators subject to this rule comply with provisions of 29 CFR 1910.133(b) for requirements on selection and use of eye and face protection. EPA is soliciting comments on the requirements proposed for appropriate PPE selection, the effectiveness of PPE in preventing direct dermal contact with PCE in the workplace, and general absorption and permeation effects to PPE from direct dermal exposure. In addition, EPA understands that some workplaces rinse and reuse PPE after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing certain types of PPE, either gloves or protective clothing and gear. EPA also requests comment on the degree to which additional guidance related to use of PPE might be appropriate. EPA is also proposing that owners and operators retain records of dermal PPE used and program implementation. EPA proposes to require that owners and operators document in the exposure control plan or other documentation of the facility’s safety and health program, information relevant to any dermal PPE program, as applicable, including: (A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle PCE or handle equipment or materials on which PCE may present and the type of PPE selected to be worn by each of these persons; (B) The basis for specific PPE selection (e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area); (C) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE; (D) Occurrence and duration of any direct dermal contact with PCE that occurs during any activity or malfunction at the workplace that causes direct dermal exposures to occur and/or glove breakthrough, and corrective actions to be taken during and immediately following that activity or malfunction to prevent direct dermal contact to PCE; and (E) Training in accordance with 29 CFR 1910.132(f), including any re-training. EPA may require more, less, or different PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 documentation in the final rule based on consideration of public comments. e. General WCPP Requirements i. Exposure Control Plan. EPA proposes to require that owners and operators document their exposure control strategy and implementation in an exposure control plan or through adding EPA-required information to any existing documentation of the facility’s safety and health program developed as part of meeting OSHA requirements or other safety and health standards. EPA proposes to require that each owner or operator document in the exposure control plan the following: (A) Identification and rationale of exposure controls used or not used in the following sequence: elimination of PCE, substitution of PCE, engineering controls, and administrative controls to reduce exposures in the workplace to either at or below the ECEL or to the lowest level achievable and to prevent or reduce direct dermal contact with PCE in the workplace; (B) The exposure controls selected based on feasibility, effectiveness, and other relevant considerations; (C) If exposure controls were not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented; (D) Actions taken to implement exposure controls selected, including proper installation, maintenance, training or other steps taken; (E) Description of any regulated area and how it is demarcated, and identification of authorized persons; and description of when the owner or operator expects exposures may be likely to exceed the ECEL; (F) Regular inspections, evaluations, and updating of the exposure controls to ensure effectiveness and confirmation that all persons are implementing them as required; (G) Occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes air concentrations to be above the ECEL or any direct dermal contact with PCE and subsequent corrective actions taken during start-up, shutdown, or malfunctions to mitigate exposures to PCE; and (H) Availability of the exposure control plan and associated records for potentially exposed persons. ii. Workplace Information and Training. EPA is also proposing to require implementation of a training program in alignment with the OSHA Hazard Communication Standard (29 CFR 1910.1200) and the OSHA General Industry Standard for Methylene E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons in the workplace are informed of the hazards associated with PCE exposure, EPA is proposing to require that owners or operators of workplaces subject to the WCPP institute a training and information program for potentially exposed persons and assure their participation in the training and information program. As part of the training and information program, the owner or operator would be required to provide information and comprehensive training in an understandable manner (i.e., plain language) and in multiple language as appropriate (e.g., based on languages spoken by potentially exposed persons) to potentially exposed persons prior to or at the time of initial assignment to a job involving potential exposure to PCE. In alignment with the OSHA Hazard Communication Standard, owners and operators would be required to provide information and training to all potentially exposed persons that includes (A) the requirements of the PCE WCPP and how to access or obtain a copy of the requirements of the WCPP; (B) the quantity, location, manner of use, release, and storage of PCE and the specific operations in the workplace that could result in PCE exposure; (C) principles of safe use and handling of PCE in the workplace, including specific measures the owner or operator has implemented to reduce inhalation exposures to at or below the ECEL or prevent direct dermal contact with PCE, such as work practices and PPE used; (D) the methods and observations that may be used to detect the presence or release of PCE in the workplace (such as monitoring conducted by the owner or operator, continuous monitoring devices, visual appearance or odor of PCE when being released, etc.); and (E) the health hazards associated with exposure with PCE. In addition to providing training at the time of initial assignment to a job involving potential exposure to PCE, and in alignment with the OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners and operators subject to the PCE WCPP would be required to re-train each potentially exposed person annually to ensure they understand the principles of safe use and handling of PCE in the workplace. Owners and operators would also need to update the training as necessary whenever there are changes in the workplace, such as new tasks or modifications of tasks; in particular, whenever there are changes in the workplace that increase exposure to PCE or where potentially exposed persons’ VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 exposure to PCE can reasonably be expected to exceed the action level or increase the potential for direct dermal contact with PCE. To support compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP would be required to provide to the EPA, upon request, all available materials related to workplace information and training. iii. Workplace Participation. EPA encourages owners or operators to consult with persons that have potential for exposure on the development and implementation of exposure control plans and PPE/respirator programs. EPA is proposing to require owners or operators to provide potentially exposed persons or their designated representatives regular access to the exposure control plans, exposure monitoring records, and PPE program implementation and documentation. To ensure compliance in workplace participation, EPA is proposing that the owner or operator document the notice to and ability of any potentially exposed person that may reasonably be affected by PCE inhalation exposure or direct dermal contact with PCE to readily access the exposure control plans, facility exposure monitoring records, PPE program implementation, or any other information relevant to PCE exposure in the workplace. EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program. iv. Recordkeeping. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to WCPP retain compliance records for five years. EPA is proposing to require records to include: (A) the exposure control plan; (B) PPE program implementation and documentation, including as necessary, respiratory protection and dermal protection used and related PPE training; and (C) information and training provided to each person prior to or at the time of initial assignment and any re-training. In addition, EPA is proposing that owners and operators subject to the WCPP ECEL requirements maintain records to include: (D) The exposure monitoring records; (E) Notification of exposure monitoring results; and (F) To the extent that the owner or operator relies on prior exposure monitoring data, records that demonstrates that it meets all of the requirements of this section. PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 39679 The owners and operators, upon request by EPA, would be required to make all records that are maintained as described in this unit available to EPA for examination and copying in accordance with EPA requirements. All records required to be maintained by this unit could be kept in the most administratively convenient form (electronic or paper). v. Compliance timeframes. EPA is proposing to require each owner or operator of a workplace subject to an ECEL conduct initial baseline monitoring according to the process outlined in this unit by 6 months after date of publication of the final rule in the Federal Register or within 30 days of introduction of PCE into the workplace if PCE use commences at least 6 months after the date of publication. EPA is proposing to require each owner or operator ensure that the airborne concentration of PCE does not exceed the ECEL for all potentially exposed persons within 9 months after the date of publication of the final rule in the Federal Register, or beginning 4 months after introduction of PCE into the workplace if PCE use commences at least 6 months after the date of publication. EPA is also proposing to require owners and operators demarcate and maintain a regulated area wherever exposures exceed or can reasonably be expected to exceed the ECEL beginning 9 months after the date of publication of the final rule in the Federal Register, or beginning 4 months after introduction of PCE into the workplace if PCE use commences at least 6 months after the date of publication. If applicable, EPA is also proposing that each owner or operator must provide respiratory protection sufficient to reduce inhalation exposures to below the ECEL to all potentially exposed persons in the regulated area within 3 months after receipt of the results of any exposure monitoring that indicates exposures exceeding the ECEL or, if using monitoring data conducted within five years prior to the effective date of this rule that satisfies all other requirements of this section, within 9 months after the date of publication of the final rule in the Federal Register. Regulated entities should then proceed accordingly to implement an exposure control plan within 12 months after date of publication of the final rule in the Federal Register. EPA requests comment relative to the ability of owners or operators to conduct initial monitoring within 6 months after date of publication of the final rule in the Federal Register, and anticipated timelines for any procedural E:\FR\FM\16JNP3.SGM 16JNP3 39680 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules adjustments needed to comply with the requirements outlined in this unit, including establishment of a respiratory protection program and development of an exposure control plan. With regard to the compliance timeframe for those occupational conditions of use which are subject to DDCC requirements, EPA is proposing to require each owner and operator of a workplace subject to DDCC establish the process outlined in this unit by 12 months after publication of the final rule in the Federal Register. EPA requests comment relative to the ability of owners or operators to implement such processes within 12 months of publication of the final rule in the Federal Register, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. 3. Prescriptive Controls a. Overview ddrumheller on DSK120RN23PROD with PROPOSALS3 In contrast to the proposed nonprescriptive requirements of the ECEL and DDCC where regulated entities would have flexibility to select controls in accordance with the hierarchy of controls to comply with the parameters outlined in this unit, EPA may also find it appropriate in certain circumstances to require specific prescriptive controls for certain occupational conditions of use. In the 2020 Risk Evaluation for PCE, EPA identified certain workplace controls that reduce exposures from PCE adequate to address the unreasonable risk driven by inhalation exposures from the industrial and commercial use of PCE in laboratory chemicals. Therefore, EPA is proposing to require specific prescriptive controls for the industrial and commercial use of PCE in laboratory chemicals, as described in this unit. This unit describes proposed requirements for a fume hood and dermal PPE for the industrial and commercial use of PCE in laboratory chemicals, including additional requirements proposed for recordkeeping. This unit also describes compliance timeframes for these proposed requirements. b. Workplace Requirements for Laboratory Use To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to PCE identified for the industrial and commercial use as a laboratory chemical, EPA is proposing to require dermal PPE in combination VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 with comprehensive training for tasks particularly related to the use of PCE in a laboratory setting as specified in this unit for each potentially exposed person to direct dermal contact with PCE. Additionally, EPA is proposing to require the use of fume hoods in workplaces engaged in the laboratory chemical condition of use 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). Each owner or operator of a workplace where the industrial and commercial use of PCE as a laboratory chemical occurs would be responsible for compliance with the requirements outlined in this unit. EPA’s description for how these requirements would address the unreasonable risk and the rationale for this regulatory approach is outlined in Unit III.B.3. and Unit V.A. EPA is proposing to require dermal PPE, including impermeable gloves and protective clothing, in combination with comprehensive training for tasks where there is potential for direct dermal contact with PCE (see Unit IV.A.2.d.). In selecting and providing appropriate dermal PPE and providing PPE training, owners and operators would be required to follow the PPE program and dermal protection requirements laid out in Unit IV.A.2.d.ii. Unlike DDCC, this proposed provision would not require owners and operators to use elimination, substitution, engineering controls, and administrative controls, prior to relying on PPE, as a means of controlling exposures in accordance with the hierarchy of controls. For laboratory fume hoods, EPA is proposing to require each owner or operator of a workplace engaged in the laboratory chemical condition of use to ensure fume hoods are in use and functioning properly to minimize exposures to potentially exposed persons in the area where PCE is used as a laboratory chemical. EPA suggests owners or operators refer to OSHA’s 29 CFR 1910.1450, appendix A National Research Council Recommendations Concerning Chemical Hygiene in Laboratory, for ventilation system characteristics and practices to minimize exposures to workers in the area. As noted in these non-mandatory recommendations, which are based on the National Research Council’s 2011 edition of ‘‘Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards,’’ recommended practices for laboratory chemical hoods include, but are not limited to, regularly inspecting and maintaining the ventilation system, ensuring a negative pressure differential between the PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 amount of air exhausted from the laboratory and the amount supplied to the laboratory to prevent uncontrolled chemical vapors from leaving the laboratory, and preventing laboratory air from recirculating back into the laboratory (Ref. 47). EPA requests comment on whether it should incorporate in the rule best practices to ensure proper and adequate performance of laboratory fume hoods, such as those identified in OSHA’s 29 CFR 1910.1450, Appendix A National Research Council Recommendations Concerning Chemical Hygiene in Laboratory. To support and demonstrate compliance, EPA is proposing that each owner or operator of a laboratory workplace subject to the requirements of this unit retain compliance records for five years. EPA is proposing to require records to include: (A) PPE program implementation and documentation as outlined in this unit; and (B) Implementation of a properly functioning fume hood using manufacturer’s instructions for installation, use, and maintenance of the fume hood, including inspections, tests, development of maintenance procedures, the establishment of criteria for acceptable test results, and documentation of test and inspection results. Every five years, the owner or operator would be required to update these records. EPA is proposing to require that each owner or operator of a workplace engaged in the industrial and commercial use of PCE as a laboratory chemical ensure fume hoods are in use and functioning properly and dermal PPE is provided to all potentially exposed persons to direct dermal contact with PCE according to the process outlined in this unit within 12 months after publication of the final rule. EPA requests comment relative to the ability of owners or operators to implement laboratory chemical fume hood and dermal PPE related requirements within 12 months of publication of the final rule, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. 4. Other Requirements a. Recordkeeping In addition to the recordkeeping requirements for the WCPP and prescriptive controls outlined in this unit, for conditions of use that are not otherwise prohibited under this E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules proposed regulation, EPA is also proposing that manufacturers, processors, distributors, and commercial users maintain ordinary business records, such as invoices and bills-oflading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation; and to maintain such records for a period of 5 years from the date the record is generated. EPA is proposing that this requirement begin at the effective date of the rule (60 days following publication of the final rule in the Federal Register). Recordkeeping requirements would ensure that owners or operators can demonstrate compliance with the regulations if necessary. EPA may require more, less, or different documentation in the final rule based on consideration of public comments. RULE IN THE FEDERAL REGISTER]; and Disposal. b. Downstream Notification For conditions of use that are not otherwise prohibited under this proposed regulation, EPA is proposing that manufacturers (including importers), processors, and distributors, excluding retailers, of PCE and PCEcontaining products provide downstream notification of the prohibitions through the Safety Data Sheets (SDS) required by OSHA under 29 CFR 1910.1200(g) by adding to sections 1(c) and 15 of the SDS the following language: 5. TSCA Section 6(g) Exemptions Under TSCA section 6(g)(1), EPA may grant an exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use of a chemical substance or mixture if EPA makes one of three findings required by the statute. TSCA section 6(g)(1)(A) permits such an exemption if EPA finds that the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure. TSCA section 6(g)(1)(B) permits such an exemption if EPA finds that compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure. Finally, TSCA section 6(g)(1)(C) allows for an exemption if EPA finds that the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. TSCA section 6(g)(2) requires EPA to analyze the need for the exemption, and to make public the analysis and a statement on how the analysis was taken into account when proposing an exemption under TSCA section 6(g). Based on discussions with and information provided by the National Aeronautics and Space Administration (NASA), EPA has analyzed the need for an exemption for certain uses of PCE in an emergency in the furtherance of NASA’s mission and is proposing to grant it. This unit presents the results of that analysis. Pursuant to TSCA section 6(g)(3), if an exemption is finalized, EPA may by rule later extend, modify, or eliminate the After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] this chemical/ product cannot be distributed in commerce to retailers for any use. After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], this chemical/product is and can only be distributed in commerce or processed for the following purposes: Processing as a reactant/intermediate; Processing into formulation, mixture or reaction product in cleaning and vapor degreasing products; Processing into formulation, mixture or reaction product in paint and coating products; Processing into formulation, mixture or reaction product in adhesive and sealant products; Processing by repackaging; Recycling; Industrial and commercial use as solvent in vapor degreasing; Industrial and commercial use in maskant for chemical milling; Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing; Industrial and commercial use in laboratory chemicals; Industrial and commercial use in solvent-based adhesives and sealants; Industrial and commercial use in dry cleaning in 3rd generation machines until [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; Industrial and commercial use in dry cleaning and related spot cleaning until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 The intention of downstream notification is to spread awareness throughout the supply chain of the restrictions on PCE under TSCA as well as provide information to commercial end users about allowable uses of PCE. To provide adequate time to update the SDS and ensure that all products in the supply chain include the revised SDS, EPA is proposing a 2-month period for manufacturers and a 6-month period for processors and distributers to implement the proposed SDS changes following publication of the final rule. EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this unit. PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 39681 exemption, on the basis of reasonably available information and after adequate public justification, if EPA determines the exemption warrants a change. EPA will initiate this rulemaking process at the request of any regulated entity benefiting from such an exemption. The Agency is open to engagement throughout the duration of any 6(g) exemption, and emphasizes that to ensure continuity in the event of an extension or modification, such a request should come at least 2 years prior to the expiration of an exemption. a. Analysis of the Need for TSCA Section 6(g)(1)(A) Exemption for Certain NASA Uses in an Emergency for Which no Technically or Economically Feasible Safer Alternative is Available EPA considered a TSCA section 6(g) exemption for emergency use of PCE in the furtherance of NASA’s mission. For certain specific conditions of use, EPA proposes that use of PCE by NASA and its contractors in an emergency be exempt from the requirements of this rule because it is a critical or essential use provided that (1) there is an emergency; and (2) NASA selected PCE because there are no technically and economically feasible safer alternatives available during the emergency. NASA operates on the leading edge of science seeking innovative solutions to future problems where even small volumes of an otherwise prohibited chemical substance could be vital to crew safety and mission success. During interagency review, NASA expressed concerns that there will likely be circumstances where a specific, EPAprohibited condition of use may be identified by NASA during an emergency as being needed in order to avoid or reduce situations of harm or immediate danger to human health, or the environment, or avoid imperiling NASA space missions. In such cases, it is possible that no technically and economically feasible safer alternative would be available that meets the stringent technical performance requirements necessary to remedy harm or avert danger to human health, the environment, or avoid imperiling NASA space missions. An emergency is a serious and sudden situation requiring immediate action to remedy harm or avert danger to human health, the environment, or to avoid imperiling NASA space missions. In NASA’s case, there may be instances where the emergency use of PCE for specific conditions of use is critical or essential to remedying harm or averting danger to human health, the environment, or avoiding imperiling NASA space missions. Because of the E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39682 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules immediate and unpredictable nature of emergencies described in this unit and of the less forgiving environments NASA operates in that offer little to no margin for error, it is likely that, at the time of finalization of this proposal, alternatives to emergency PCE use may not be available in a timely manner to avoid or reduce harm or immediate danger (Ref. 48). In this way, these emergencies for particular conditions of use meet the criteria for an exemption under TSCA section 6(g)(1)(A), because the emergency use of PCE for listed conditions of use is critical or essential and no technically and economically feasible safer alternative will be available in a timely manner, taking into consideration hazard and exposure. In support of the TSCA section 6(g)(1)(A) emergency use exemption, NASA submitted detailed criteria which they must use to screen, qualify, and implement materials to be used in spacecraft equipment, as well as historical case studies that outline the loss of life and loss of assets in the discharge of previous missions. In one of several examples detailed, the Apollo I command module fire that claimed the lives of three American astronauts demonstrated the need for careful testing and continuity of materials (Ref. 48). Moreover, due to NASA’s rigorous safety testing requirements under various environmental conditions, technically and economically feasible safer alternatives may not be readily available during emergencies and may require certain conditions of use of PCE to alleviate the emergency. In another example, NASA identified a scenario concerning a mission to the International Space Station (ISS) whereby, during a launch evolution, the countdown was paused immediately prior to launch (T–2 minutes). NASA engineers identified a clogged filter and supply line as the primary issue, which required immediate attention (i.e., line flushing and filter cleaning). In this type of emergency scenario, an already approved chemical substance rated for space system applications is necessary to immediately remedy the situation. Although PCE was not used in this particular incident, if it were needed, in the future to address such an emergency, then the proposed exemption would allow for its lawful use—the countdown would resume and the launch would occur. Conversely, without an exemption under the specific condition of use (e.g., industrial and commercial use in wipe cleaning), NASA’s use of PCE would be otherwise prohibited, which would put NASA in an untenable position of having to choose to either violate the law or place VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 the mission (and potentially the health and safety of its employees involved in the mission) at risk. The identification and qualification of compatible materials in the context of aviation is iterative and involves expansive collaboration between original equipment manufacturers, federal agencies, and qualifying institutions. This is equally, if not more so, the case in the context of human space flight operations undertaken by NASA (Ref. 48). NASA’s mission architecture requirements often are developed many years in advance of an actual launch occurring. As part of mission planning, space systems are designed, full scale mock-ups are built, and mission critical hardware is constructed using materials qualified for spaceflight. Once NASA’s mission architecture requirements are developed, NASA may need to retain emergency access to PCE because its alternatives may not have yet gone through NASA’s rigorous certification process before their use. Allowing NASA to retain emergency use of PCE would reduce the chances that this rulemaking will hinder future space missions for which mission architecture infrastructure is being developed or is already built. While NASA considers alternatives to the chemical substances it currently uses in its space system designs, NASA has not yet identified technically and economically feasible alternatives to proven chemistries in many current applications. While EPA acknowledges that the use of PCE in emergency situations may be necessary in the near term, it is also EPA’s understanding that NASA will continue its work to identify and qualify alternatives to PCE. Thus, EPA is proposing an exemption duration of 10 years. b. Proposed Exemption for Certain Emergency Uses of PCE in the Context of Human Space Flight For the reasons discussed in this Unit, EPA is proposing a 10-year exemption for emergency use of PCE in furtherance of NASA’s mission for the following specific conditions of use: Industrial and commercial use as solvent for cold cleaning; Industrial and commercial use in wipe cleaning. EPA is also proposing to include additional requirements as part of the exemption, pursuant to TSCA section 6(g)(4), including required notification and controls for exposure, to the extent feasible: (1) NASA and its contractors must provide notice to the EPA Administrator of each instance of emergency use within 15 days and; (2) NASA and its contractors would have to PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 comply with the WCPP described in Unit IV.A.2 to the extent feasible. EPA is proposing to require that NASA notify EPA within 15 days of the emergency use. The notification would include a description of the specific use of PCE in the context of one of the conditions of use for which this exemption is being proposed, an explanation of why the use described qualifies as an emergency, and an explanation with regard to the lack of availability of technically and economically feasible alternatives. EPA expects NASA and its contractors have the ability to implement a WCPP as described in Unit IV.A.2. for the identified uses in the context of an emergency, to some extent even if not to the full extent of WCPP implementation. Therefore, EPA is proposing to require that during emergency use, NASA must comply with the WCPP to the extent technically feasible in light of the particular emergency. Under the proposed exemption, NASA and its contractors would still be subject to the proposed general recordkeeping requirements discussed in Unit IV.A.4. EPA requests comment on this TSCA section 6(g) exemption for continued emergency use of PCE in the furtherance of NASA’s mission as described in this unit, and whether any additional conditions of use should be included, in particular for any uses qualified for space flight for which no technically and economically feasible safer alternative is available. Additionally, EPA requests comment on what would constitute sufficient justification of an emergency. B. Alternative Regulatory Actions As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA must consider and publish a statement based on reasonably available information with respect to the reasonably ascertainable economic consequences of the rule, including consideration of the costs and benefits and the cost effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions considered by the Agency. This unit includes a description of the primary alternative regulatory action and the second alternative regulatory action considered by the Agency. An overview of the proposed regulatory action and two alternative regulatory actions for each condition of use is in Unit IV.C. 1. Primary Alternative Regulatory Action Considered The primary alternative regulatory action described in this document and E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 considered by EPA combines prohibitions, requirements for a WCPP, and prescriptive controls to address the unreasonable risk from PCE driven by the various conditions of use. While in some ways it is similar to the proposed regulatory action, the primary alternative regulatory action described in this document differs from the proposed regulatory action by providing for a WCPP, including requirements to meet an ECEL or DDCC, for some conditions of use that would be prohibited under the proposed regulatory action. The primary alternative regulatory action also considers 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. The primary alternative regulatory action additionally includes longer compliance timeframes for prohibitions and implementation of WCPP and prescriptive controls, as described in this unit. EPA requests comment on this primary alternative regulatory action and whether any elements of this primary alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. EPA is requesting comment on whether to consider a regulatory alternative that would subject more conditions of use to a WCPP, instead of prohibition, than those currently contemplated in the primary alternative regulatory action. EPA also requests 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 also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. a. Prohibitions The primary alternative regulatory action considered by EPA would prohibit the manufacturing, processing, distribution in commerce, and use for the following industrial and commercial uses, which EPA is also proposing to prohibit as part of the proposed regulatory action: industrial and commercial use as solvent for cold cleaning; industrial and commercial use in other textile processing; industrial and commercial use in wood furniture manufacturing; industrial and commercial use as a solvent for aerosol lubricants; industrial and commercial VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 use in wipe cleaning; industrial and commercial use in other spot cleaning and spot removers, including carpet cleaning; industrial and commercial use in automotive care products (e.g., engine degreaser and brake cleaner); industrial and commercial use in non-aerosol cleaner; industrial and commercial use in metal (e.g., stainless steel) and stone polishes; industrial and commercial use in foundry applications; industrial and commercial use as a solvent for penetrating lubricants and cutting tool coolants; industrial and commercial use in welding; industrial and commercial use for mold release; commercial use for photographic film; commercial use in inks and ink removal products (based on printing); commercial use in inks and ink removal products (based on photocopying); and commercial use in metal mold cleaning, release and protectant products. Additionally, the primary alternative regulatory action would prohibit the manufacture, processing, and distribution of PCE for consumer use. As shown in Unit IV.C., which presents an overview of the proposed regulatory action and two alternative regulatory actions for each condition of use, the primary alternative action described in this document would prohibit fewer occupational conditions of use than the proposed regulatory action. Regarding compliance timeframes, the primary alternative regulatory action would include longer timeframes for implementation of the prohibitions than the proposed regulatory action. Under the primary alternative action, the prohibitions would generally take effect 6 months later than in the proposed regulatory action. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the prohibitions for the manufacturing, processing, distribution in commerce, and use of PCE for certain occupational conditions of use described in this unit would take effect 18 months for manufacturers, 21 months for processers, 24 months for distributing to retailers, 27 months for all other distributors (including retailers), and 30 months for industrial and commercial uses after the publication date of the final rule. With regard to the compliance timeframe for the manufacturing, processing, and distribution in commerce for consumer use (other than consumer use of clothing and articles that have been commercially dry cleaned with PCE), under the primary alternative regulatory action, prohibitions described in this unit would take effect in 18 months for manufacturers, 21 months for PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 39683 processors, 24 months for distributing to retailers, and 27 months for all other distributors (including retailers) after the publication date of the final rule. Like the proposed action, the primary alternative regulatory action would also phaseout the manufacturing, processing, distribution in commerce, and commercial use of PCE for dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry machines with refrigerated condenser) and 4th/5th generation (dry-to-dry machines with refrigerated condenser and carbon adsorber process controls) machines. However, the timeframes for the phaseout differ between the proposed action and the primary alternative action, described later in this unit. As described in Unit IV.A.3., a prohibition on these conditions of use would address the unreasonable risk driven by the following uses: industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning; industrial and commercial use in dry cleaning and spot cleaning 4th/5th generation only dry cleaning; and consumer use in dry cleaning solvent. With regards to the prohibition of dry cleaning conditions of use, under the primary alternative regulatory action, the following phaseout timeline would take effect after the publication date of the final rule: prohibition on the use of PCE in dry cleaning machines acquired 12 months after the publication date of the final rule; a prohibition on the use of PCE in 3rd generation machines 5 years after the publication date of the final rule; a prohibition on the use of PCE in dry cleaning and spot cleaning 15 years after the publication date of the final rule; and a prohibition on the manufacturing, processing, and distribution in commerce of PCE for use in dry cleaning solvent 15 years after the publication date of the final rule. b. Workplace Chemical Protection Program (WCPP) The primary alternative regulatory action described in this document would require a WCPP, including requirements to meet an ECEL and DDCC, for the following conditions of use: industrial and commercial use in laboratory chemicals; processing into formulation, mixture, or reaction product in other chemical products and preparations; industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing; industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair); industrial and commercial use in solvent-based paints and coatings; and industrial and commercial use as E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39684 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules solvent for aerosol spray degreaser/ cleaner. As described in Unit V.A., uncertainties regarding (i) the feasibility of implementing workplace safety control measures in open-systems or when worker activities require manual application or removal of PCE or PCEcontaining products, (ii) availability of alternatives, or (iii) whether the use is ongoing or phased out led EPA to propose that most of these conditions of use be prohibited. EPA does not have sufficient information to confidently conclude that these conditions of use can meet requirements of a WCPP for PCE. Therefore, EPA requests comment on the ways in which PCE may be used in these conditions of use, including whether activities may take place in a closed system and the degree to which users of PCE in these sectors could successfully implement an ECEL, DDCC, and ancillary requirements described in Unit IV.A. For the industrial and commercial use in laboratory chemicals, EPA is soliciting comment on nonprescriptive requirements of an ECEL and DDCC as compared to the prescriptive workplace controls of fume hood and dermal PPE EPA is proposing in Unit IV.A.3. As with the compliance timeframes considered as part of the primary alternative action for prohibition, the primary alternative regulatory action also includes longer compliance timeframes for implementation of a PCE WCPP. Under the primary alternative action, the requirements for the WCPP would take effect 6 months later than in the proposed regulatory action. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the requirements for owners and operators to conduct initial baseline monitoring would take effect 12 months after the date of publication of the final rule in the Federal Register. The requirements for each owner or operator to provide respiratory protection to all potentially exposed persons in the regulated area would be within 3 months after receipt of the results of any exposure monitoring or within 15 months after date of publication of the final rule in the Federal Register. Regulated entities would be required to implement an exposure control plan within 18 months after date of publication of the final rule in the Federal Register. EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 c. Prescriptive Controls The primary alternative regulatory action described in this document would require prescriptive workplace PPE controls for the following conditions of use (which are all conditions of use for which EPA is proposing WCPP as part of the proposed regulatory action): manufacturing (domestic manufacturing); manufacturing (import); processing as a reactant/intermediate; processing into formulation, mixture or reaction product in cleaning and degreasing products; processing into formulation, mixture or reaction products in paint and coating products; processing into formulation, mixture, or reaction product in adhesive and sealant products; processing by repackaging; recycling; industrial and commercial use as a solvent for open-top batch vapor degreaser; industrial and commercial use as solvent for closedloop batch vapor degreasing; industrial and commercial use as solvent for inline conveyorized vapor degreasing; industrial and commercial use as solvent for in-line web cleaner vapor degreaser; industrial and commercial use in maskant for chemical milling; and industrial and commercial use as processing aid in catalyst regeneration in petrochemical manufacturing; and disposal. Additionally, the primary alternative regulatory action described in this document would require a concentration limit for the industrial and commercial use in solvent-based adhesives and sealants. i. Prescriptive controls—PPE. In the 2020 Risk Evaluation for PCE, EPA identified gloves that would reduce dermal exposures to PCE. Under the primary alternative regulatory action, EPA considered requiring dermal PPE as described in Unit IV.A.2.c. This approach differs from the proposed regulatory action because it does not require the use of elimination, substitution, engineering controls and administrative controls or work practices, in accordance with the hierarchy of controls, to the extent feasible as a means of controlling dermal exposures to comply with the DDCC. Rather, this approach would require dermal PPE and training to prevent direct dermal contact with PCE as described in Unit IV.A.2.c.iv. EPA is soliciting comment on prescribing specific dermal PPE, such as gloves, for each condition of use that should be considered as EPA develops the final regulatory action. For inhalation exposures in the 2020 Risk Evaluation for PCE, EPA identified APFs for respirators that would mitigate PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 the unreasonable risk for the conditions of use. However, as described in Unit V.A., EPA has uncertainty that the respirator APF identified in the 2020 Risk Evaluation for PCE for each condition of use is appropriate for the wide variety of workplaces that may be engaged in each condition of use, as each workplace has unique characteristics that impact PCE air concentration levels. For example, EPA expects that some users may already have existing controls in place that reduce PCE air concentration levels below the ECEL (Refs. 49, 50), whereas other users of the same condition of use have different workplace controls that result in air concentration levels above the ECEL. Under the primary alternative regulatory action, EPA considered setting minimum respiratory PPE requirements based on an entity’s measured air concentration and the level of PPE needed to reduce exposures to the ECEL, as described in Units IV.A.2.d.i. This approach differs from the proposed regulatory action because it does not require the use of elimination, substitution, engineering controls and administrative controls or work practices, in accordance with the hierarchy of controls, to the extent feasible as a means of controlling inhalation exposures to comply with the ECEL. Rather, this approach would require respirators where inhalation exposures exceed the ECEL based on exposure monitoring. In addition to minimum respiratory PPE requirements, the primary alternative regulatory action would require initial monitoring within 12 months after publication of the final rule and periodic monitoring once every five years to determine the respiratory protection needed as described in Unit IV.A.2. as well as establishment of a regulated area as described in Unit IV.A.2., establishment of PPE program as described in Unit IV.A.2. and notification of monitoring results as described in Unit IV.A.2., with modifications to not require implementation of all feasible exposure controls according to the hierarchy of controls. EPA is soliciting comment on prescribing specific respirators or APFs for respirators for each condition of use that should be considered as EPA develops the final regulatory action. EPA understands that many workplaces already have engineering controls or administrative controls in place that reduce exposures to PCE, in particular highly standardized and industrialized workplaces or where PCE is used in a closed system. However, EPA does not have reasonably available information on engineering controls and E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules administrative controls that would mitigate unreasonable risk across a wide variety of workplaces for most occupational conditions of use. EPA is requesting comment on specific controls that mitigate the unreasonable risk from PCE and that could be included as part of a prescriptive workplace controls requirement, which could be considered as EPA develops the final regulatory action. Specifically, EPA is soliciting comment on combinations of specific engineering controls, administrative controls, and PPE that would reduce inhalation exposures to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal contact with PCE for all workplaces where such controls would be required. Examples of controls and workplace practices include a vapor recovery system (e.g., carbon adsorption system or condenser), enclosed transfer liquid lines (with purging mechanisms in place (e.g., nitrogen, aqueous), equipment such as portable scrubber units to minimize vapor, ventilation units that mitigate vapor escape, and limiting frequency and duration of exposure to PCE. For vapor degreasing, EPA understands that the European Union and Germany have established requirements for reducing emissions of volatile organic compounds, such as the Solvent Emissions Directive and the German 2 BlmSchV standard for use of chlorinated hydrocarbons in surface cleaning. EPA is soliciting comment on the extent to which such requirements could reduce inhalation exposures to at or below the ECEL of 0.14 ppm as an 8hour TWA. As with the compliance timeframes considered as part of the primary alternative action for prohibition and WCPP, the primary alternative regulatory action includes longer compliance timeframes for implementation of prescriptive PPE controls. Under the primary alternative action, the requirements for prescriptive controls would take effect 6 months later than in the proposed regulatory action. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the requirements for owners and operators to provide dermal PPE and training would take effect 18 months after the publication date of the final rule. For respirator selection and demarcating a regulated area, the requirements for owners and operators to conduct initial baseline monitoring would take effect 12 months after the date of publication of the final rule and requirements to provide a respirator and demarcate a regulated area would take effect 18 months after the publication date of the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 final rule. EPA is requesting comment on the compliance timeframe needed to implement engineering controls, administrative controls, and PPE that reduce inhalation exposures to at or below the ECEL of 0.14 ppm as an 8hour TWA or prevent direct dermal contact with PCE for all regulated entities. ii. Prescriptive controls— concentration limit. To reduce exposures in the workplace and address the unreasonable risk of injury to health from PCE for the industrial and commercial use in solvent-based adhesives and sealants, EPA considered setting a concentration limit of PCE in adhesive and sealant products. The primary alternative regulatory action described in this document would limit the concentration of PCE in adhesive and sealant products to 1% by weight. Any percentage of PCE greater than 1% by weight would be prohibited for the industrial and commercial use of solvent-based adhesive and sealants products. Additionally, the primary alternative regulatory action would prohibit the import, processing, and distribution in commerce of adhesive and sealant products containing PCE at concentrations greater than 1% by weight. EPA has uncertainty that a concentration limit would reduce inhalation exposures such that PCE no longer presents an unreasonable risk, and therefore did not propose a concentration limit as the preferred option, as described in this Unit. In the 2020 Risk Evaluation for PCE, EPA identified adhesive and sealant products containing PCE at concentrations ranging from as low as 0.1% PCE by weight to as high as 100% PCE by weight, including several industrial adhesive products with concentrations of PCE below 1% by weight. In considering a concentration limit as a regulatory action to address the unreasonable risk from inhalation and dermal exposures for the industrial and commercial use of solvent-based adhesives and sealants, EPA reviewed the dermal exposure modeling in the 2020 Risk Evaluation for PCE and conducted additional analysis of inhalation exposure data for adhesive products containing PCE below 1% PCE by weight (Ref. 51). Based on the dermal exposure modeling in the 2020 Risk Evaluation for PCE, EPA determined that limiting the concentration of PCE in adhesive and sealant products to 1% would address the unreasonable risk resulting from dermal exposures (Ref. 52). In additional analysis of inhalation exposure data for adhesives in support of risk management, EPA estimated inhalation exposures to PCE from PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 39685 adhesives containing PCE at concentrations ranging from 0.1% to 0.9% using four different approaches. In the analysis, inhalation exposure estimates for central tendency in all four approaches resulted in exposures below the ECEL. However, high-end exposure estimates varied across the four approaches, with two approaches resulting in high-end exposure estimates below the ECEL and two approaches resulting in high-end exposure estimates above the ECEL. The inhalation exposure estimates provided in the additional inhalation analysis are a result of several key assumptions and uncertainties, as described in the memo (Ref. 51). EPA therefore has uncertainties regarding whether a concentration limit of 1% PCE in adhesives and sealants would address the unreasonable risk resulting from inhalation exposures in occupational settings. Therefore, EPA is requesting comment on a combination of the 1% concentration limit for adhesives and sealants with specific engineering controls, administrative controls, or respiratory protection that would reduce inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-hour TWA. Additionally, EPA is requesting comment on a combination of a concentration limit with WCPP requirements as described in Unit IV.A.2. EPA also requests monitoring data, formulations used, and detailed descriptions of PCE involving activities for the industrial and commercial use in solvent-based adhesives and sealants to determine whether a concentration limit would reduce inhalation exposures such that risks are no longer unreasonable. As part of the primary alternative regulatory action, the concentration limit of 1% by weight of PCE for adhesive and sealant products would only be for products intended for industrial and commercial use. As described in Unit IV.B.1.a., the primary alternative regulatory action would prohibit the manufacture, processing, and distribution of PCE for consumer use, including consumer use in adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant, livestock grooming adhesive, column adhesive, caulk and sealant). EPA examined the Consumer Exposure Model for the 2020 Risk Evaluation for PCE and found that, when adjusting parameters for product mass and duration of use to the highest values based on consumer product data in the 2020 Risk Evaluation for PCE for consumer adhesive conditions of use, limiting the concentration of PCE to 1% by weight in consumer use of products E:\FR\FM\16JNP3.SGM 16JNP3 39686 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules would not eliminate the unreasonable risk from PCE resulting from inhalation and dermal exposures (Ref. 53). Regarding compliance timeframes under the primary alternative action, the prohibitions for the import, processing, distribution in commerce, and use of adhesive and sealant products containing PCE at concentrations greater than 1% by weight described in this unit would take effect 18 months for importers, 21 months for processers, 24 months for distributing to retailers, 27 months for all other distributors (including retailers), and 30 months for industrial and commercial uses after the publication date of the final rule. ddrumheller on DSK120RN23PROD with PROPOSALS3 2. Second Alternative Regulatory Action Considered The second alternative regulatory action, as with the proposed regulatory action and the primary alternative regulatory action, is a combination of prohibition and a WCPP to address the unreasonable risk from PCE driven by the various conditions of use. While in most ways it is similar to the proposed regulatory action, the second alternative regulatory action differs from the proposed regulatory action by prohibiting some conditions of use that would have requirements for a WCPP under the proposed regulatory action. Additionally, the second alternative regulatory action proposes a TSCA section 6(g) time-limited exemption from prohibition for the industrial and commercial use of PCE as maskant for chemical milling and the industrial and commercial use of PCE for vapor degreasing. The second alternative regulatory action also includes shorter compliance timeframes for prohibitions and a WCPP, as described in this unit. EPA requests comment on this second alternative regulatory action and whether any elements of this second alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. a. Prohibitions The second alternative action would prohibit more occupational conditions of use than the proposed regulatory action. In addition to the conditions of use that EPA is proposing to prohibit in the proposed regulatory action, the second alternative regulatory action described in this action would also prohibit the following conditions of use: processing into formulation, mixture or reaction product in paint and coating VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 products; processing into formulation, mixture, or reaction product in cleaning and degreasing products; processing into formulation, mixture or reaction product in adhesive and sealant products; industrial and commercial use as solvent for open-top batch vapor degreasing; industrial and commercial use as solvent for closed-loop batch vapor degreasing; industrial and commercial use as solvent for in-line conveyorized vapor degreasing; industrial and commercial use as solvent for in-line web cleaner vapor degreasing; industrial and commercial use in solvent-based adhesives and sealants; and industrial and commercial use in maskants for chemical milling. Additionally, the second alternative regulatory action would prohibit the manufacture, processing, and distribution of PCE for consumer use. Like the proposed action, the second alternative regulatory action would also prohibit the manufacturing, processing, distribution in commerce, and commercial use of PCE for dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry machines with refrigerated condenser) and 4th/5th generation (dry-to-dry machines with refrigerated condenser and carbon adsorber process controls) machines. However, the timeframes for the phaseout differ between the proposed action and the second alternative action, described later in this unit. As described in Unit IV.A.3., a prohibition on these conditions of use would address the unreasonable risk driven by the following uses: industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning; industrial and commercial use in dry cleaning and spot cleaning 4th/5th generation only dry cleaning; and consumer use in dry cleaning solvent. Regarding compliance timeframes, the second alternative regulatory action would include more stringent timeframes for implementation of prohibition than the proposed regulatory action. Additionally, EPA would not stagger the compliance dates for manufacturers, processors, and distributors. The prohibitions for the manufacturing, processing, distribution in commerce, and use for certain industrial and commercial uses described in this unit would take effect 12 months after the publication date of the final rule. With regard to the compliance timeframe for the manufacturing, processing, and distribution in commerce for consumer use, under the second alternative regulatory action, prohibitions described in this unit would take effect 12 months after the publication date of PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 the final rule. With regard to prohibition of dry cleaning conditions of use, under the second alternative regulatory action, the following would occur: prohibition on the use of PCE in dry cleaning machines acquired after the effective date of the final rule; a prohibition on the use of PCE in 3rd generation machines 6 months after the publication date of the final rule; a prohibition on the use of PCE in dry cleaning and spot cleaning 5 years after the publication date of the final rule; and a prohibition on the manufacturing, processing, and distribution in commerce of PCE for use in dry cleaning solvent 5 years after the publication date of the final rule. b. TSCA Section 6(g) Exemptions Under TSCA section 6(g)(1), EPA may grant an exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use of a chemical substance or mixture if EPA makes one of three findings required by the statute, as outlined in Unit IV.A.5. TSCA section 6(g)(2) requires EPA to analyze the need for the exemption, and to make public the analysis and a statement on how the analysis was taken into account when proposing an exemption under TSCA section 6(g). Based on discussions with and information provided by industry stakeholders, consultation with the DOD and NASA, and Panel recommendations in the SBAR Panel Report (Ref. 33), EPA has analyzed the need for three different exemptions and would grant two if the second alternative regulatory action described in this document is adopted in the final rule. This unit presents the results of that analysis. i. Analysis of the need for a TSCA section 6(g)(1)(B) exemption for industrial and commercial use of PCE in maskant for chemical milling essential for national security and critical infrastructure. EPA has conducted an analysis of the application of this rulemaking to the industrial and commercial use of PCE in maskant for chemical milling and found that a TSCA section 6(g) exemption may be warranted if the second alternative regulatory action considered by EPA is adopted, in its entirety or in relevant part, in the final rule. Based on discussions with and information provided by industry stakeholders, EPA understands that PCE-based maskant is used in commercial and defense aerospace programs that are essential for national security and critical infrastructure (Refs. 54, 55). For example, one facility that comprises 85% of the U.S. market for PCE-based maskant chemical milling uses PCE in the Boeing fuselage manufacturing program for the 737, 747, 767, and 777 E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules and also in defense products for the Bell V–280 Valor, Boeing P–8, Sikorsky CH– 53K, Boeing KC–46, and Northrop Grumman B–21. Based on information submitted by industry, the purpose of maskant in chemical milling is to remove excess weight of aluminum not required for structural integrity in commercial and defense products. This process is performed on aluminum aircraft ‘‘skins,’’ which are large metal sheets or panels. PCE is used at the beginning of the chemical milling process as a temporary diluent for maskant applied to aircraft skins to prevent chemical milling of certain areas. After application, the maskant cover is scribed in specific locations and dry maskant is pulled or removed, exposing aluminum metal, while the PCE evaporates and is captured into a recovery system. Information submitted by stakeholders notes that PCE does not remain on the airplane skins when the skins are etched nor at any other point after the chemical milling stage of fabrication. According to information submitted by industry, PCE-based maskant is required to meet certain performance requirements that other alternatives are unable to meet. For example, PCE-based maskant meets several Boeing Aircraft process specifications such as ‘‘Chemical Milling Aluminum Alloys’’ (BAC 5772), ‘‘Maskant Trimming of Fatigue Critical Hardware’’ (BAC 5986), ‘‘Phosphoric Acid Anodizing of Aluminum for Structural Bonding’’ (BAC 5555), and ‘‘Appearance Control of Clad Aluminum Exterior Skins’’ (Boeing D6–9002). These process specifications are mandatory for suppliers as part of the quality system that aircraft production certificate holders are required to establish under 14 CFR 21.137. Additionally, PCE-based maskant also meets other industry performance requirements such as Stretch Forming, Laser Scribe Compatible, and General Parts Protection. Representatives from the facility that comprises 85% of the U.S. market for PCE-based maskant chemical milling have described to EPA how efforts to develop new maskant have been ongoing for over 30 years but have not yet found a substitute that meets all of the necessary performance requirements (Ref. 54). PCE-based maskant also allows for solvent capture and recycling. The same company has recaptured and recycled more than 95% of the PCE used for more than 29 years, the remaining PCE being captured using special filters, mats, and nonrecoverable mediums that are disposed of by a company that specializes in VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 providing environmental services for controlled chemicals (Ref. 55). As discussed in this unit and in the Alternatives Assessment (Ref. 56), substitute chemicals for maskant for chemical milling may not meet the performance requirements of maskant needed for chemical milling of aluminum aircraft skins for commercial and defense purposes and thus may not be technically feasible as alternatives. Therefore, EPA has preliminarily determined that if PCE-based maskant were not available, or if industry cannot meet the requirements of the WCPP in the proposed regulatory action or of the prescriptive controls considered as the primary alternative regulatory action, there would be a significant disruption to national security and critical infrastructure. In addition, due to availability concerns, EPA has preliminarily determined that a ban on the manufacture, processing, and distribution in commerce of PCE-based maskant could also significantly disrupt national security and critical infrastructure. A prohibition on the use of PCE for chemical milling of aluminum aircraft skins could affect the ability to make available new military aircraft on schedule, and consequently, potentially affect DOD’s capability and readiness. Such a prohibition would also affect the availability of new civilian aircraft and thus have negative impacts on civilian aviation. Aviation has been designated by the Department of Homeland Security as a key subsector in the Transportation Systems Sector, one of 16 designated critical infrastructure sectors. Based on the expected significant disruption to national security and critical infrastructure, a TSCA section 6(g) exemption may be warranted if the proposed and primary alternative regulatory actions are not suitable to address the unreasonable risk driven by this condition of use. Therefore, as part of the second alternative regulatory action, EPA would grant a 10-year exemption from prohibition for the industrial and commercial use of PCE as maskant for chemical milling. EPA believes that the information provided by industry on the time needed to identify and qualify substitutes supports a 10-year exemption period. Further, the industry submitter has provided information demonstrating that engineering controls are already in place to lower, to the extent possible, exposure concentrations to PCE and to limit occupational exposures, including supplementing with PPE during tasks that may result in greater exposure. Based on the information submitted, EPA understands that existing controls PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 39687 ensure airborne concentrations of PCE are generally kept below 1 ppm as an 8hour TWA (below the existing regulatory and voluntary occupational exposure limits described in Units II.C.4. and 5.). While EPA acknowledges that the airborne concentration may exceed the ECEL, the exemption as part of the second alternative regulatory action would include the following provisions to ensure that exposures are reduced to the lowest levels achievable:: the proposed general recordkeeping requirements discussed in Unit IV.A.4.i., documentation of the engineering controls and PPE used to reduce potentially exposed persons’ exposure to the extent possible, and records that demonstrate compliance with the exemption conditions, including the condition that PCE only be used for chemical milling of aluminum aircraft skins. EPA requests comments on all aspects of the section 6(g) exemption from the prohibition on industrial and commercial use of PCE in maskant for chemical milling as part of the second alternative regulatory option, including information on the extent to which this industry could meet the requirements of the proposed WCPP or prescriptive controls, whether compliance with specific elements of the proposed WCPP should also be required during the period of the exemption, and the time period of the exemption pursuant to TSCA section 6(g)(3). ii. Analysis of the need for a TSCA section 6(g)(1)(B) exemption for industrial and commercial use of PCE in vapor degreasing essential for national security and critical infrastructure. EPA has conducted an analysis of the application of this rulemaking to the industrial and commercial use of PCE in vapor degreasing and found that a TSCA section 6(g) exemption may be warranted if the second alternative regulatory action considered by EPA is adopted, in its entirety or in relevant part, in the final rule. EPA received a request for a section 6(g) exemption from prohibition for the use of PCE in vapor degreasing of aerospace parts from a manufacturer of commercial jetliners and defense, space, and security systems (Refs. 57, 58). The aerospace parts have commercial, DOD, and NASA uses (Ref. 59); as the requester describes, they manufacture and procure these parts and have identified that PCE vapor degreasing is necessary due to technical challenges with other alternative substitute chemicals or methods. The requester has spent many years developing, qualifying, and implementing alternative materials and E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39688 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules processes to replace PCE vapor degreasing with aqueous cleaning where technically viable. According to the requester, while the transition to aqueous cleaning has been successful for many detail parts, there are technical challenges with alternative substitute chemicals and processes for the vast majority of complex aerospace machining parts and actuation systems, such as structural components, gears, and other parts that make up drive units and control mechanisms. The requester states that PCE vapor degreasing is the best cleaning method to pre-clean most complex machining parts and actuation systems because it does not allow the transfer of contaminates from one part to another. The requester notes that, for those parts approved for aqueous cleaning, the parts so cleaned must be carefully segregated to avoid crosscontamination, which substantially increases the required processing time. The requester notes that an adequate transition period for this technically challenging aerospace use requires substantial investment and time to develop viable alternatives. The requester is currently in the process of identifying a replacement solvent that can adequately clean, cause no harm to parts, and is not an equally toxic material to PCE. Based on the submitted request, conversion from vapor degreasing to aqueous cleaning is a capital-intensive investment that the requester expects would require several years to plan, permit, construct, and install. Additionally, the requester notes that the aerospace industry needs to ensure that aerospace parts meet DOD and other Federal Aviation Administration (FAA) specifications to ensure safety of flight. For example, in order to replace the chemical with an alternative, the requester notes that they must identify, test, and select an alternative that meets technical requirements derived from FAA mandated standards for a typical part used in a commercial aircraft, such as specifications for specific gravity (ASTM D 792), Water Absorption (ASTM D 750), and other test requirements, which may be a lengthy process (Ref. 60). According to the information submitted, certification with FAA could take at least nine months for individual parts of components or up to several years for major subsystems or complete aircraft (Ref. 60). The requester also notes that while they do not know the extent that their supply chain has transitioned away from use of PCE in vapor degreasing, PCE has been used in vapor degreasing to meet required levels of VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 cleanliness of certain supplied parts by long-standing design specifications that are incorporated into contracts of a complex supply chain. The requester also told EPA the suppliers are not required to inform the requester of the process they use to clean parts that the supplier provides to the requester, and the requester therefore may not know which solvent a supplier has selected for vapor degreasing or what factors were considered when selecting cleaning systems. According to the requester, material declarations and auditing processes to validate usage may be burdensome, considering that a large portion of the requester’s supply chain includes small suppliers. Due to the concerns raised with transitioning to aqueous cleaning or another new cleaning method, the requester has requested that EPA exempt use of PCE in vapor degreasing of aerospace parts for 10 years. As discussed in this unit, information submitted by the requester indicates that substitute chemicals for vapor degreasing of aerospace parts may not be technically feasible at this time for meeting the cleanliness standards of certain parts as required by DOD and FAA specifications or other specifications included in existing contracts within the supply chain. According to the requester, more time is needed for companies to make the capital-intensive transition from PCE vapor degreasing to aqueous cleaning for those parts that can be cleaned using the aqueous method. In addition, the requester states that they are continuing to work towards identifying a replacement solvent that is able to adequately clean complex machining parts and actuation systems parts without harming them, and that is not a regrettable substitution. Therefore, EPA has preliminarily determined that if the use of PCE for vapor degreasing were not available in the near term for aerospace parts, or if industry could not meet the requirements of the WCPP as proposed or of the prescriptive controls considered as the primary alternative regulatory action, compliance with such requirements would significantly disrupt national security and critical infrastructure. In addition, due to availability concerns, EPA has preliminarily determined that a ban on the manufacture, processing, and distribution in commerce of PCE for vapor degreasing of aerospace parts could also significantly disrupt national security and critical infrastructure. A prohibition on the use of PCE for vapor degreasing of aerospace parts in the near term could negatively affect DOD’s PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 capability and readiness, which includes the ability to adequately maintain aircraft. Such a prohibition could also negatively affect the maintenance of civilian aircraft and potentially have impacts on the safety of civilian flight. For the reasons discussed in this unit, EPA would grant a 10-year exemption from prohibition as part of the second alternative regulatory action for the industrial and commercial use of PCE in vapor degreasing for aerospace parts. EPA believes that the information provided by the requester on the time needed to identify and qualify substitutes supports a 10-year exemption period. Further, the requester has provided information demonstrating that engineering controls are in place to lower, to the extent possible, exposure concentrations and limit occupational exposures to PCE. The exemption would also include the following conditions: the proposed general recordkeeping requirements discussed in Unit IV.A.4.i., documentation of the engineering controls used to reduce potentially exposed persons’ exposure, and records to demonstrate compliance with the exemption conditions, including the condition that PCE only be used in vapor degreasing for aerospace parts where other alternatives present technical feasibility or cleaning performance challenges to meet DOD and FAA specifications or other longstanding design specifications that are included in existing contracts. EPA requests comments on all aspects of the exemption request and proposed exemption from the prohibition on use of PCE in vapor degreasing as part of the second alternative regulatory action, including information on the extent to which this industry could meet the requirements of the proposed WCPP or prescriptive controls and whether compliance with specific elements of the proposed WCPP should also be required during the period of the exemption. EPA is requesting comment on whether vapor degreasing of parts and components for non-aerospace applications should also be exempt from prohibition as part of the second alternative regulatory action for the industrial and commercial use of PCE in vapor degreasing. To facilitate EPA’s consideration of exemptions for other sectors, comments in support of additional exemptions should include detailed explanations of why and how long exemptions would be needed. Additionally, EPA is soliciting comment on whether it should specify the type of vapor degreasing operation, such as closedloop batch vapor degreasing, that would E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules be exempt from prohibition as part of the second alternative regulatory action for the industrial and commercial use of PCE in vapor degreasing for aerospace parts and whether it should consider different exemption timeframes for different types of vapor degreasing operations. iii. Analysis of the need for a TSCA section 6(g) exemption for industrial and commercial use of PCE in dry cleaning. Following Panel recommendations in the SBAR Panel Report (Ref. 33), EPA has considered a TSCA section 6(g) exemption for the use of PCE in dry cleaning and has not found that a TSCA section 6(g) exemption is warranted. As discussed in Units IV.A.1.c. and V.A.1., based on consideration of the irreversible health effects associated with PCE exposures, the uncertainty that this sector can comply with a WCPP and reduce exposures sufficiently to address the unreasonable risk, and reasonably available information that indicates that alternatives, such as high flash point hydrocarbons and wet cleaning, are available, EPA determined that a prohibition would be the most appropriate way to eliminate the identified risks that drive the unreasonable risk to health resulting from the following conditions of use: industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning; industrial and commercial use in dry cleaning and spot cleaning 4th/5th generation only dry cleaning; and consumer use in dry cleaning solvent (i.e., exposure to clothing or articles recently dry cleaned with PCE). EPA has uncertainty regarding whether industrial and commercial dry cleaning and spot cleaning users can comply with the provisions of the WCPP, including reducing air concentration to below the ECEL and complying with the WCPP implementation measures such as periodic monitoring, a PPE program, and developing an exposure control plan that reduces exposures in a manner aligns with the hierarchy of controls where PPE is the least preferred option. This uncertainty includes considerations of worker tasks that may occur in open-systems or may require manual application or exposure to PCE or PCE-containing products (e.g., manual stain removal, garment unloading, or transferring solvent from storage container to machine that EPA VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 understands are common tasks at dry cleaning facilities) and difficulties related to respiratory protection, as described in Unit V.A. Based on reasonably available information, including market research, existing State actions restricting the use of PCE in dry cleaning, and engagement with industry, trade associations, and State and local agencies, EPA has determined that a phaseout period of five to fifteen years, as is included in the proposed regulatory action and alternative regulatory actions, are reasonable compliance timeframes to allow dry cleaners time to transition away from PCE. EPA requests comments on all aspects of this analysis of a need for an exemption under TSCA section 6(g), including information on the whether the specific use may be critical or essential, the availability of technically and economically feasible safer alternatives, and the time needed to implement alternatives. c. Workplace Chemical Protection Program (WCPP) The second alternative regulatory action considered by EPA would require a WCPP as described in Unit IV.A. for the following conditions of use: manufacturing (domestic manufacturing); manufacturing (import); processing as a reactant/intermediate; processing by repackaging; recycling; industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing; and disposal. As with the proposed regulatory action, under the second alternative regulatory action, recycling and disposal would not be subject to the WCPP ECEL requirements. As with the compliance timeframes considered as part of the second alternative regulatory action for prohibition, the second alternative regulatory action also includes shorter compliance timeframes for implementation of the PCE WCPP than the proposed regulatory action. Under the second alternative action, the requirements for WCPP would take effect 3 months sooner than in the proposed regulatory action. Under a compliance timeframe that is 3 months shorter than the proposed regulatory action, the requirements for owners and operators to conduct initial baseline monitoring would take effect 3 months after the date of publication of the final rule in the Federal Register. Each owner or operator would be required to PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 39689 provide respiratory protection to all potentially exposed persons in the regulated area within 3 months after receipt of the results of any exposure monitoring or within 6 months after date of publication of the final rule in the Federal Register. Regulated entities would be required to implement an exposure control plan within 9 months after date of publication of the final rule in the Federal Register. EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. d. Prescriptive Controls The second alternative regulatory action considered by EPA would require fume hood and dermal PPE for the industrial and commercial use as a laboratory chemical, as described in Unit IV.A.3. As with the compliance timeframes considered as part of the second alternative action for prohibition and WCPP, the second alternative regulatory action also includes shorter compliance timeframes for implementation of prescriptive controls. Under the second alternative action, the requirements for prescriptive controls would take effect 3 months sooner than in the proposed regulatory action. Under a compliance timeframe that is 3 months shorter than the proposed regulatory action, requirements that owners and operators provide dermal PPE and a fume hood would take effect 9 months after the publication date of the final rule. C. Overview of conditions of Use and Proposed Regulatory Action and Alternative Regulatory Actions. Table 2 is a side-by-side depiction of the proposed regulatory action with the primary and second alternative actions for each condition of use identified as driving the unreasonable risk (Ref. 2). The purpose of this table is to succinctly convey to the public the major differences between the proposed regulatory action and the alternative regulatory actions; as such the actions in each column are truncated and do not reflect all the details of the proposed and alternative regulatory actions, including differences in timeframes. The proposed and alternative regulatory actions are described more fully in Units IV.A. and B. E:\FR\FM\16JNP3.SGM 16JNP3 39690 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules TABLE 2—OVERVIEW OF CONDITIONS OF USE DRIVING UNREASONABLE RISK AND PROPOSED REGULATORY ACTION AND ALTERNATIVE REGULATORY ACTIONS Action Condition of use driving unreasonable risk determination ddrumheller on DSK120RN23PROD with PROPOSALS3 Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing. Industrial and commercial use in laboratory chemicals .. Industrial and commercial use in paints and coatings in maskants for chemical milling. Industrial and commercial use as solvent for open-top batch vapor degreaser. Industrial and commercial use as solvent for closedloop batch vapor degreaser. Industrial and commercial use as solvent for in-line conveyorized vapor degreaser. Industrial and commercial use as solvent for in-line web cleaner vapor degreaser. Industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing. Industrial and commercial use in specialty DOD uses (oil analysis and water pipe repair). Industrial and commercial use in solvent-based adhesives and sealants. Industrial and commercial use in solvent-based paints and coatings. Industrial and commercial use as solvent for aerosol spray degreaser/cleaner. Industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning. Industrial and commercial use in dry cleaning and spot cleaning 4th/5th gen only dry cleaning. Industrial and commercial use as solvent for cold cleaning. Industrial and commercial use in other textile processing. Industrial and commercial use in wood furniture manufacturing. Commercial use for photographic film ............................ Industrial and commercial use as a solvent for aerosol lubricants. Industrial and commercial use in wipe cleaning ............. Industrial and commercial use in other spot cleaning and spot removers, including carpet cleaning. Industrial and commercial use in automotive care products (e.g., engine degreaser and brake cleaner). Industrial and commercial use in non-aerosol cleaner ... Industrial and commercial use in metal (e.g., stainless steel) and stone polishes. Industrial and commercial use in foundry applications ... Commercial use in inks and ink removal products (based on printing). Industrial and commercial use in welding ....................... Industrial and commercial use for mold release ............. Commercial use in inks and ink removal products (based on photocopying). Commercial use in metal mold cleaning, release and protectant products. Industrial and commercial use as a solvent for penetrating lubricants and cutting tool coolants. Consumer use in dry cleaning solvent ............................ Consumer use in automotive care products (parts cleaner). Consumer use in lubricants and greases (lubricants and penetrating oils). Consumer use in adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant). Consumer use in adhesives for arts and crafts (livestock grooming adhesive). Consumer use in adhesives for arts and crafts (column adhesive, caulk and sealant). VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 PO 00000 Proposed regulatory action Primary alternative action PCE WCPP ....................... Prescriptive Controls (PPE) PCE WCPP. Prescriptive Controls (fume hood, dermal PPE). PCE WCPP ....................... PCE WCPP ....................... Prescriptive Controls (PPE) Prescriptive Controls (fume hood, dermal PPE). Prohibit.1 PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit.1 PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit.1 PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit.1 PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit.1. Prohibit .............................. PCE WCPP ....................... Prohibit. Prohibit .............................. PCE WCPP ....................... Prohibit. PCE WCPP ....................... Prohibit. Prohibit .............................. Prescriptive Controls (Concentration limit). PCE WCPP ....................... Prohibit .............................. PCE WCPP ....................... Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit .............................. Prohibit .............................. Prohibit. Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibi 2 ............................. Prohibit.2 Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Frm 00040 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 16JNP3 Second alternative action Prohibit. Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules 39691 TABLE 2—OVERVIEW OF CONDITIONS OF USE DRIVING UNREASONABLE RISK AND PROPOSED REGULATORY ACTION AND ALTERNATIVE REGULATORY ACTIONS—Continued Action Condition of use driving unreasonable risk determination Proposed regulatory action Primary alternative action Consumer use in solvent-based paints and coatings (coatings and primers (aerosol)). Consumer use in solvent-based paints and coatings (metallic overglaze). Consumer use in welding ................................................ Consumer use in metal mold cleaning, release and protectant products. Consumer use in cleaners and degreasers (other) ........ Consumer use in automotive care products (brake cleaner). Consumer use in aerosol cleaner (vandalism mark and stain remover). Consumer use in non-aerosol cleaner (e.g., marble and stone polish). Consumer use in lubricants and greases (cutting fluid) Consumer use in solvent-based paints and coatings (outdoor water shield (liquid)). Consumer use in solvent-based paints and coatings (rust primer and sealant (liquid)). Consumer use in metal (e.g., stainless steel) and stone polishes. Consumer use in inks and ink removal products ............ Manufacturing (domestic manufacturing) ........................ Manufacturing (import) .................................................... Processing as a reactant/intermediate ............................ Processing into formulation, mixture or reaction product in paint and coating products. Processing into formulation, mixture or reaction product in cleaning and degreasing products. Processing into formulation, mixture or reaction product in other chemical products and preparations. Processing into formulation, mixture or reaction product in adhesive and sealant products. Repackaging .................................................................... Recycling ......................................................................... Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ Prohibit 2 ............................ Prohibit.2 Prohibit 2 ............................ PCE WCPP ....................... PCE WCPP ....................... PCE WCPP ....................... PCE WCPP ....................... Prohibit 2 ............................ Prescriptive Controls (PPE) Prescriptive Controls (PPE) Prescriptive Controls (PPE) Prescriptive Controls (PPE) Prohibit.2 PCE WCPP. PCE WCPP. PCE WCPP. Prohibit. PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit. Prohibit .............................. PCE WCPP ....................... Prohibit. PCE WCPP ....................... Prescriptive Controls (PPE) Prohibit. PCE WCPP ....................... PCE WCPP ....................... PCE WCPP. PCE WCPP. Disposal ........................................................................... PCE WCPP ....................... Prescriptive Controls (PPE) Prescriptive Controls (dermal PPE). Prescriptive Controls (dermal PPE). 1 TSCA Second alternative action PCE WCPP. section 6(g) exemption, including the manufacture (including import), processing, and distribution for this condition of use. manufacture (including import), processing, and distribution in commerce for the consumer use. 2 Prohibit V. Rationale for the Proposed Regulatory Action and Alternative Regulatory Actions This unit describes how the considerations described in Unit III.B.3. were applied when selecting among the TSCA section 6(a) requirements to arrive at the proposed and alternative regulatory actions described in Unit IV. ddrumheller on DSK120RN23PROD with PROPOSALS3 A. Consideration of Risk Management Requirements Available Under TSCA Section 6(a) 1. Proposed Regulatory Action a. Prohibition EPA considered a prohibition as a regulatory option and is proposing it for certain occupational conditions of use (Unit IV.A.). Prohibition is the preferred option for occupational conditions of use where greater uncertainty exists relative to a sector’s ability to comply VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 with provisions of the proposed PCE WCPP, such as an ECEL or DDCC. EPA’s 8-hour TWA ECEL for PCE is significantly lower than the OSHA PEL and there is a degree of uncertainty as to whether chemical users under the conditions of use in some sectors will be able to comply with such a level and thus whether the unreasonable risk would be addressed. This uncertainty includes consideration of the difficulties related to respiratory protection, which are discussed in more detail in Unit V.A.1.b., and which include how respirators may present communication problems, vision problems, worker fatigue, and reduced work efficiency (63 FR 1152, January 8, 1998) as well as consideration for that fact that not all workers may be able to wear respirators. Similarly, there is also uncertainty regarding certain chemical users’ ability to prevent direct dermal contact with PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 PCE, in particular during use in opensystems or when worker activities require manual application or removal of PCE or a PCE-containing product through rags, aerosols, spray guns, roll applicators, fingers, hands, or other materials. Additionally, prohibition is the preferred option for occupational conditions of use where reasonably available information suggests minimal ongoing use or when feasible safer alternatives are reasonably available. The uncertainties related to whether users under certain conditions of use could comply with the requirements of a PCE WCPP, combined with the severity of the risks of PCE, the prevalence of alternative processes and products (Unit V.B), and in some cases reasonably available information indicating a use is no longer ongoing (Refs. 56, 3), has led EPA to propose prohibitions for most industrial and E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39692 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules commercial uses of PCE, as well as for the upstream manufacturing, processing, and distribution in commerce for those uses. EPA requests comment regarding the number of businesses and other entities that could potentially close as well as associated costs with a prohibition of PCE for the industrial and commercial conditions of use identified in Unit IV.A.1. As outlined in Unit IV.A.1., EPA is proposing to phase out the use of PCE in dry cleaning and associated spot cleaning at dry cleaning facilities. While EPA recognizes the exposure reductions and significant investments in equipment improvements made by dry cleaners, as described by SERs and summarized in the SBAR Panel Report (Ref. 33), EPA has determined that the industrial and commercial uses of PCE in dry cleaning and the consumer use of PCE in dry cleaning drive the unreasonable risk for PCE, and is proposing that prohibition is the most appropriate approach to eliminate the unreasonable risk. Following the Panel recommendations in the SBAR report (Ref. 33), EPA is providing an assessment on the impact of the rule on the dry cleaning industry in the Economic Analysis (Ref. 3), summarized here. Based on consultation with stakeholders, EPA understands that the use of PCE in dry cleaning is currently declining. Stakeholders, including State and Local Agencies and trade associations, have noted an overall yearto-year decline in the use of PCE in dry cleaning and many expect PCE to phase out naturally or decrease to extremely low numbers as older machines are retired and alternative solvents are adopted (Ref. 61). As described more fully in the Economic Analysis, EPA assumes dry cleaning machines are retired 15 to 25 years after the manufactured date. Therefore, EPA assumes most dry cleaning machines manufactured and installed before 2005, such as for 3rd generation machines, would be beyond their projected useful life by the proposed phaseout dates outlined in Unit IV.A.1. Additionally, reasonably available information on the current use of alternatives to PCE in dry cleaning, including cost, effectiveness, and safety, indicate suitable alternatives are available (Refs. 61, 62). As described more fully in the Economic Analysis, EPA expects that multi-solvent or hydrocarbon dry cleaning machines are likely to be the most common alternatives to PCE dry cleaning. However, other alternatives, such as wet cleaning, are available (Refs. 27, 28, 29, 30, 31). EPA determined prohibition would not be suitable for the remaining VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 occupational conditions of use, such as processing as a reactant/intermediate and several types of processing into a formulation, mixture, or reaction product; and industrial and commercial uses as a solvent for cleaning and degreasing in vapor degreasers, particularly for aerospace and defense applications, in maskant for chemical milling, in solvent-based adhesives and sealants, as a processing aid in catalyst regeneration in petrochemical manufacturing, and as a laboratory chemical. EPA made this determination based on compelling reasons to not prohibit the activity and identification of a different regulatory action that would address the unreasonable risk. For example, prohibition may not be suitable for conditions of use that may complement the Agency’s efforts to address climate-damaging HFCs under the AIM Act, or have national security or other significance for critical sectors, where EPA identified strict workplace controls could be implemented for these uses to address the unreasonable risk as described in Unit V.A.1.b. Additionally, prohibition may not be suitable for conditions of use where alternative substances to PCE are more or equally hazardous, in particular for other solvents undergoing risk evaluation and risk management under TSCA section 6. For example, for processing as a reactant/intermediate, PCE and trichloroethylene (TCE) are both used as feedstock in the manufacture of HFC– 134a although they are not drop in substitutes. As another example, PCE, TCE, 1-bromopropane, methylene chloride, and trans-1,2-dichloroethylene are solvents used in vapor degreasing and have or are currently undergoing risk evaluation or risk management under TSCA. In selecting among the TSCA section 6(a) requirements for the proposed approach for conditions of use where alternative substances to PCE may include other solvents undergoing risk evaluation and risk management under TSCA section 6, EPA considered whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute. For these conditions of use, EPA determined restrictions under a PCE WCPP were more suitable for addressing the unreasonable risk to the extent necessary so that PCE no longer presents such risk, while also allowing flexibility for regulated entities to continue operations, as described in this unit and in Unit IV.A. Regarding industrial, commercial, and consumer uses of PCE, TSCA section 6(a)(2) provides EPA with the authority to prohibit or otherwise restrict the PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 manufacture (including import), processing, or distribution in commerce of a substance or mixture ‘‘for a particular use’’ to ensure that a chemical substance no longer presents unreasonable risk. For this rule, EPA proposes that ‘‘for a particular use’’ includes consumer use more broadly, as well as industrial and commercial use, which encompasses all known, intended, and reasonably foreseen uses of PCE. Given the severity and ubiquitous nature of the risks identified in the 2020 Risk Evaluation for PCE for all industrial, commercial, and consumer uses evaluated, and noting that those conditions of use evaluated in the Risk Evaluation encompass all known, intended, and reasonably foreseen uses of PCE, EPA proposes that prohibiting manufacture (including import), processing, and distribution in commerce of PCE for most industrial and commercial use and all consumer use is reasonable and necessary to eliminate the unreasonable risk of PCE, including by precluding retailers from selling PCE and PCE-containing products to consumers. EPA believes that any retailer selling PCE-containing products to consumers would be selling products for one of the consumer uses EPA evaluated in the 2020 Risk Evaluation for PCE and found to drive the unreasonable risk for PCE. Other regulatory options that would restrict the manufacture (including import), processing, and distribution in commerce of PCE for consumer use, such as setting a concentration limit, would not adequately address the identified unreasonable risk driven by consumer use. EPA’s proposed requirements to address unreasonable risk to consumers and bystanders to consumer use are described in Unit IV.A. A key consideration regarding consumer use is the role of retailers and other distributors. A retailer, as EPA has defined in 40 CFR 751.103 (and proposes to define in 40 CFR 751.5), is any entity that makes available a chemical substance or mixture to consumer end users, including ecommerce internet sales or distribution. Previously, in the 2019 methylene chloride TSCA section 6(a) risk management rule addressing consumer use of methylene chloride in paint and coating removal (40 CFR part 751, subpart B), EPA prohibited retailers from distributing in commerce paint and coating removers containing methylene chloride (see 40 CFR 751.105(b) and (c)). To meet the same goal of protecting consumers from accessing PCE-containing products that E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules could pose unreasonable risk, for a broader range of consumer conditions of use, EPA considered and is proposing a similar provision to ensure that retailers will not be able to purchase PCE for sale or distribution to consumers and will not be able to sell or distribute PCE to consumers, including making available to consumers products containing PCE. For these reasons, as described in Unit IV.A., EPA’s proposal to address unreasonable risk from PCE includes prohibition on the distribution in commerce of PCE to and by retailers. To support implementation of the proposed prohibitions EPA also considered, and is proposing, a de minimis level for products containing PCE to account for impurities that do not drive the unreasonable risk. EPA conducted an analysis using the methodology in the 2020 Risk Evaluation for PCE to estimate whether there is a weight fraction of PCE in industrial/commercial and consumer products below which the industrial/ commercial and consumer uses of those products, respectively, would not drive the unreasonable risk from PCE. EPA examined the Consumer Exposure Model for the 2020 Risk Evaluation for PCE and found that, when adjusting parameters for product mass and duration of use to the highest values based on consumer product data in the 2020 Risk Evaluation for PCE, consumer use of products that are 0.124% PCE or less by weight would not drive the unreasonable risk from PCE (Ref. 53). To identify a concentration limit of PCE in industrial/commercial products that would not drive the unreasonable risk from PCE, EPA also conducted an analysis using the Brake Servicing NearField/Far-Field exposure model in the 2020 Risk Evaluation for PCE and calculated that a PCE concentration of 0.7% in aerosol brake degreasing products would achieve exposure concentrations at or below the ECEL based on a near-field 8-hour TWA of 0.145 ppm at the 95th percentile (Ref. 45). Based on these analyses, EPA is proposing to exclude from prohibition products containing PCE at less than 0.1% by weight, as described in Unit IV.A. EPA has identified uncertainties with a concentration limit of 0.1% addressing the unreasonable risk. For example, the Brake Services Near-Field/ Far-Field exposure model is based on a scenario for occupational brake cleaning and may less accurately estimate exposures from other applications where exposures may be different than those predicted by the model, for example due to higher PCE application rates or lower ventilation rates. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 However, a concentration limit of 0.1% provides a margin of error to account for the uncertainties associated with the 0.7% concentration limit identified in the analysis using the Brake Servicing Near-Field/Far-Field exposure model. EPA is requesting comment on the de minimus concentration limit of PCE in products or formulations, and provides more information on consideration of a concentration limit in Unit V.A.3. Details of the proposed prohibitions are described in more detail in Unit IV.A. b. Workplace Chemical Protection Program (WCPP) One option EPA considered for occupational conditions of use was establishing requirements for a PCE WCPP, which would include a combination of requirements to the extent necessary to address unreasonable risk driven by inhalation and dermal exposures in the workplace. A PCE WCPP would encompass restrictions on certain occupational conditions of use and could include provisions for an ECEL, DDCC, and ancillary requirements to support implementation of these exposure limits. Due to the low exposure level and stringent requirements in the PCE WCPP that would be necessary to address the unreasonable risk from PCE, EPA identified only a relatively small number of conditions of use where the Agency expected a PCE WCPP could be successfully implemented. Existing Chemical Exposure Limit. One requirement considered by EPA to include in a PCE WCPP to address unreasonable risk driven by inhalation exposures to PCE for occupational conditions of use was establishing an ECEL and related implementation measures, such as exposure monitoring. As described in Unit IV.A., the PCE WCPP would be non-prescriptive, in the sense that regulated entities would not be required to use specific controls prescribed by EPA to achieve the exposure concentration limit. Rather, it would be a performance-based exposure limit that would enable owners or operators to determine how to most effectively meet the exposure limit based on conditions at their workplace, consistent with the hierarchy of controls. A central component of the PCE WCPP is the exposure limit. Exposures remaining at or below the ECEL would address any unreasonable risk of injury to health driven by inhalation exposures for occupational conditions of use. In the case of PCE, EPA has calculated the ECEL to be 0.14 parts per million (ppm) (0.98 mg/m3) for inhalation exposures as an 8-hour TWA in PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 39693 workplace settings, based on the chronic, non-cancer HEC for neurotoxicity (CNS) (Ref. 10). This is the concentration at which an adult human, including a member of a susceptible subpopulation, would be unlikely to suffer adverse effects if exposed for a working lifetime. The differences between the ECEL and the OSHA PEL are discussed in more detail in Unit II.C.1.b. EPA chose the chronic noncancer neurotoxicity endpoint for PCE as the basis for this exposure limit because it is the most sensitive of the endpoints identified, and therefore will be protective of both acute and chronic non-cancer and chronic cancer inhalation endpoints over the course of a working day and lifetime. In deciding whether an ECEL and related required implementation measures would appropriately address the unreasonable risk driven by occupational inhalation exposures for specific conditions of use, EPA considered factors related to work activities that may make it difficult to comply with an ECEL, particularly at the low air concentration level EPA has identified. Once EPA identified the appropriate risk-based inhalation limit to address identified unreasonable risk, EPA carefully considered the appropriateness of such an exposure control program for each occupational condition of use of PCE, in the context of the unreasonable risk. Examples include conditions of use with work activities that may take place in the field, making it challenging to establish a regulated area and conduct monitoring; work activities that may take place in open systems that require manual contact with the chemical substance; work activities that may take place in small, enclosed spaces, creating challenges for implementing engineering controls or using respiratory PPE; work activities that require a high range of motion or for some other reason create challenges for the implementation of respiratory PPE; and the type of PPE that would be needed under the PCE WCPP to meet the ECEL in the absence of, or in addition to, other feasible exposure controls, based on analysis in the 2020 Risk Evaluation for PCE describing expected exposures with and without use of PPE. EPA also considered the feasibility of exposure reduction sufficient to address the unreasonable risk, including in facilities currently complying with the OSHA PEL for PCE or implementing other recommended OELs such as the ACGIH TLV. While EPA acknowledges the regulated community’s expected familiarity with OSHA PELs generally, as well as facilities’ past and ongoing E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39694 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules actions to implement the PCE PEL, the value of EPA’s exposure limit is almost three orders of magnitude lower than the OSHA PEL (The differences between the ECEL and the OSHA PEL are discussed in more detail in Unit II.C.4; more information on other OELs is in Unit II.C.5.). This creates a degree of uncertainty as to whether facilities engaging in most conditions of use could meet the ECEL (and associated action level) and whether they could do so without relying primarily on the use of PPE (which is the least preferred option in the hierarchy of controls), and, therefore, whether exposures could be reduced in a manner aligned with the hierarchy of controls. EPA understands that this uncertainty extends to the feasibility of respirators as well. Although respirators, specifically SCBAs, could reduce exposures to levels that protect against non-cancer and cancer risks, not all workers may be able to wear respirators. Individuals with impaired lung function due to asthma, emphysema, or chronic obstructive pulmonary disease, for example, may be physically unable to wear a respirator. OSHA requires that a determination regarding the ability to use a respirator be made by a physician or other licensed health-care professional, and annual fit testing is required for tight-fitting, full-face piece respirators to provide the required protection. Individuals with facial hair, such as beards or sideburns that interfere with a proper face-to-respirator seal, cannot wear tight fitting respirators. In addition, respirators may also present communication problems, vision problems, worker fatigue, and reduced work efficiency (63 FR 1152, January 8, 1998). According to OSHA, ‘‘improperly selected respirators may afford no protection at all (for example, use of a dust mask against airborne vapors), may be so uncomfortable as to be intolerable to the wearer, or may hinder vision, communication, hearing, or movement and thus pose a risk to the wearer’s safety or health.’’ (63 FR 1189– 1190). Direct dermal contact control requirements. Another requirement considered by EPA to include in a PCE WCPP to address unreasonable risk driven by dermal exposures to PCE for occupational conditions of use was requiring DDCC. DDCC under the PCE WCPP would be a process-based requirement to prevent direct dermal contact in the workplace by separating, distancing, physically removing, or isolating potentially exposed persons from direct handling of PCE or from contact with equipment or materials on which PCE may exist under routine VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 conditions. Similar to the ECEL, DDCC is non-prescriptive, in the sense that it would not require a specific control to prevent direct dermal contact; rather, it would enable regulated entities to determine how to most effectively separate, distance, physically remove, or isolate potentially exposed persons from direct dermal contact with PCE based on what works best for their workplace, in accordance with the hierarchy of controls. In deciding whether DDCC would appropriately address the unreasonable risk driven by dermal exposures, EPA considered factors related to work activities that may make it difficult to eliminate direct dermal contact. Examples include work activities that may take place in open systems that require manual handling of PCE, such as application or removal of PCE or a PCEcontaining product through rags, aerosols, spray guns, roll applicators, fingers, hands, or other materials; or work activities that require a high range of motion or for some other reason create challenges for the implementation of dermal PPE. EPA also considered whether exposures could be reduced in a manner aligned with the hierarchy of controls and considered the type of PPE that would be needed under the PCE WCPP DDCC to prevent direct dermal contact if elimination, substitution, engineering controls, and administrative controls are not sufficient to prevent direct dermal contact. The 2020 Risk Evaluation for PCE describes expected exposures with and without use of PPE; even if chemically resistant gloves are used in combination with basic workplace training and specific activity training for tasks where dermal exposure can be expected to occur, EPA found that dermal exposures would continue to pose risk concerns for most conditions of use. However, the 2020 Risk Evaluation for PCE identifies several uncertainties regarding the dermal exposures modeled. For example, the 2020 Risk Evaluation for PCE does not consider the frequency, type, and effectiveness of gloves or other types of PPE used or specific workplaces. In addition, the 2020 Risk Evaluation for PCE does not specify the specific activity training beyond procedure for glove removal and disposal. In consideration of the whole of the 2020 Risk Evaluation for PCE, including the uncertainties, EPA has preliminarily determined that preventing direct dermal contact to PCE through DDCC requirements, including requirements to reduce exposures in a manner aligned with the hierarchy of controls, workplace specific training, and, if PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 necessary, dermal PPE which covers any exposed skin (including hands, legs, torso, and face), and PPE training, as described in Unit IV.A.2., for certain occupational conditions of use would address the unreasonable risk from dermal exposure driven by these conditions of use for potentially exposed persons. PCE WCPP. Taking into account these considerations, EPA is proposing that certain conditions of use would be allowed to continue if regulated entities could ensure exposures remain at or below the ECEL, direct dermal contact is prevented, and other requirements are met in the PCE WCPP. In contrast to considerations that would weigh against the likelihood of a facility within a condition of use to successfully implement WCPP, there are certain considerations that indicate a condition of use would likely be able to achieve effective risk management via WCPP. Based on reasonably available information, including monitoring data (Refs. 50, 49), process descriptions, and information related to considerations described previously in this unit, EPA’s confidence that requirements to meet an ECEL and prevent direct dermal contact can be implemented is highest in highly standardized and industrialized settings, such as where PCE is used in a closed system. For example, one of the conditions of use for which EPA is proposing a WCPP is processing of PCE as a reactant. A large volume of PCE is processed for this condition of use, which primarily goes towards the manufacture of HFC– 134a and HFC–125 (Refs. 3, 36). Inhalation monitoring data submitted by industry suggests that PCE exposures in some facilities may already be below levels that would be consistent with the proposed ECEL (Ref. 36). Additionally, the 2020 Risk Evaluation for PCE supports EPA’s conclusion that only small reductions in exposure are needed for WCPP ECEL compliance for processing of PCE as a reactant. Based on analysis in the 2020 Risk Evaluation for PCE describing expected exposures with and without use of PPE, EPA identified respirators of APF 25 as the minimum respiratory PPE that is sufficient to mitigate the unreasonable risk driven by inhalation exposures from this condition of use. Also, for dermal exposures, reasonably available information indicates that controls may already be in place at some workplaces to prevent or reduce direct dermal contact with PCE, including enclosed transfer liquid lines with a nitrogen purging mechanism, closed loop samplers, and impervious glove liners E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules in addition to chemically resistant gloves (Ref. 63). Another condition of use for which EPA is proposing the WCPP is the industrial and commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing. EPA understands that most workplaces using PCE in isomerization and catalytic reforming (the two uses of PCE in catalyst regeneration in petrochemical manufacturing) already have stringent controls in place that reduce workplace exposures. As described in public comments and through engagement with the American Fuel and Petrochemical Manufacturers (AFPM), other industry trade associations, and individual firms, petroleum refineries use PCE in continuous, closed processes, where it is completely consumed (Refs. 64, 66, 63). Stakeholders have described how, upon delivery by tote or tank truck at refineries, PCE is directly injected from a tote into a closed processing unit or transferred from a truck into a storage tank that is directly hooked up for direct injection in a closed system. Transfer procedures of PCE are performed pursuant to comprehensive written procedures under strict PPE guidelines including, when appropriate, respirators. Information submitted by AFPM indicates that worker exposure is limited to chemical unloading and transfer procedures, which, for AFPM members, may range from 10 to 35 times per year per site for a 15-minute tote changeout or two to 12 times per year per site for a 30- to 60-minute tank truck transfer (Ref. 64). While EPA understands that the PCE exposure frequency and duration at petroleum refineries may be less than what was assumed in the risk evaluation, as described in this unit, EPA does not have any recent air monitoring data to confirm that PCE exposures are below the proposed ECEL at petroleum refineries. Based on analysis in the 2020 Risk Evaluation for PCE describing expected exposures with and without use of PPE, EPA identified respirators of APF 10 as the minimum respiratory PPE that would be sufficient to mitigate the unreasonable risk driven by inhalation exposures from this condition of use. Also, for dermal exposures, reasonably available information indicates that controls may already be in place to prevent or reduce direct dermal contact with PCE, such as using PCE in a closed system to limit exposures and implementing comprehensive written procedures with added PPE during transfer procedures. For both of these conditions of use (processing as a reactant/intermediate VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 and industrial and commercial use in catalyst regeneration in petrochemical manufacturing) the 2020 Risk Evaluation for PCE indicates that only small reductions in exposure would be needed for WCPP compliance. This suggests that, for these conditions of use, the reductions in exposure required to achieve a level that would not result in unreasonable risk may be less than for other conditions of use. This information together with other considerations previously described, including monitoring data indicating exposures near or below the ECEL and other reasonably available information indicating stringent controls may already be in place, adds to EPA’s confidence that facilities engaging in these two conditions of use could meet the WCPP requirements. In addition to EPA’s confidence that facilities engaging in these conditions of use could meet the WCPP requirements and thus address the unreasonable risk, EPA found compelling reasons to allow continued use of PCE for these conditions of use because they may complement the Agency’s efforts to address climate-damaging HFCs under the AIM Act or have national security or other significance for critical sectors. For processing of PCE as a reactant/ intermediate, HFC–134a and HFC–125 are two of the regulated substances identified in the AIM Act. The AIM Act authorizes EPA to address listed HFCs in three main ways: phasing down HFC production and consumption through an allowance allocation program; facilitating sector-based transitions to next-generation technologies; and issuing certain regulations for purposes of maximizing reclamation and minimizing releases of HFCs from equipment and ensuring the safety of technicians and consumers. EPA anticipates that many entities currently using HFCs with higher global warming potential will transition to alternatives with lower global warming potential as requirements under the AIM Act take effect. HFC–134a and HFC–125, while being regulated substances subject to the overall phasedown in production and consumption of regulated substances under the AIM Act, are likely to be used in blends to facilitate the transition from other HFCs and HFC blends with higher global warming potential in certain applications. By allowing for the continued, controlled use of PCE in the manufacture of HFC–134a and HFC– 125, efforts to shift to chemicals or blends with lower global warming potential would not be impeded by this rulemaking. Allowing this use to continue, subject to compliance with PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 39695 the WCPP, would complement industry’s ongoing effort to abate the use of HFCs with higher global warming potential. For the industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing, information submitted to the Agency indicates that isomerization and catalytic reforming processes, which may rely on PCE for catalyst regeneration, are essential to make gasoline that is compliant with environmental regulations, such as the EPA Mobile Source Air Toxics regulations (Ref. 64, 65). Isomerization is a process that reduces the amount of benzene in fuels and catalytic reforming generates hydrogen that is used to remove sulfur compounds (Ref. 64). The resulting products from isomerization and catalytic reforming processes at petroleum refineries are isomerate and reformate, which go into gasoline blends that make up an estimated 45% of the gasoline pool in the United States (Ref. 64). Based on information submitted to the Agency, EPA believes that petroleum refineries can meet the ECEL, and so does not anticipate that there would be a meaningful impact on the price of gasoline. However, if petroleum refineries are unable to meet or are not already meeting WCPP requirements as part of the proposed regulatory action and second alternative regulatory action or the prescriptive controls as part of the primary alternative action, EPA understands that this rulemaking could result in larger impacts to the petroleum refining sector, with potential impacts that could include an increase in the price of gasoline. Therefore, EPA is requesting comment on the extent to which facilities engaged in the industrial and commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing may already meet the requirements in the proposed and alternative regulatory actions described in Unit IV. to address the unreasonable risk and is soliciting comment on the impact of such requirements on petroleum refining, with special attention to the price of gasoline. For PCE to be available for the downstream industrial and commercial uses that would continue under a PCE WCPP, it would need to be manufactured (including imported), processed, and distributed in commerce. Likewise, as long as PCE remains in use, it must also be disposed of. Therefore, EPA is proposing requirements to meet a PCE WCPP for manufacture (including import), certain processing conditions of use, and disposal, to allow for a continued supply chain for specified E:\FR\FM\16JNP3.SGM 16JNP3 39696 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 conditions of use while ensuring that workers are not subject to unreasonable risk from PCE as it moves throughout the supply chain. For recycling and disposal, EPA did not identify human health risk from inhalation exposure as a driver of unreasonable risk and is therefore not proposing to require an ECEL under the PCE WCPP for recycling and disposal activities. Details of the proposed PCE WCPP, including provisions for the ECEL, DDCC, and prescriptive controls, ancillary required implementation measures, requirements for demonstrating compliance and requirements for distributors, are described in more detail in Unit IV.A. c. Prescriptive Controls Another requirement EPA considered to address unreasonable risk for occupational conditions of use was requiring specific controls prescribed by EPA, including engineering controls, administrative controls, and/or PPE. In the 2020 Risk Evaluation for PCE, EPA identified that certain workplace controls could reduce exposures. The prescriptive controls EPA considered (such as respirators and gloves) are based on information in the 2020 Risk Evaluation for PCE. In general, prescriptive controls are not preferred as the primary method of risk management because of uncertainties related to feasibility to reduce exposures to address the unreasonable risk across all workplaces engaged in a condition of use and whether the prescriptive controls will be consistently or properly used. EPA understands that workplaces have unique processes and equipment in place and that varying levels of respiratory protection or dermal PPE may be needed for different workplaces. Additionally, as described in Unit III.A.1. and 2., EPA received input during required consultations and additional engagement that options that align with the hierarchy of controls (i.e., elimination and substitution of hazards in the workplace) should be preferred over prescriptive controls. EPA determined that specific prescriptive controls (i.e., specific engineering or administrative controls, or PPE) may not be able to eliminate unreasonable risk for some conditions of use when used in isolation. In the 2020 Risk Evaluation for PCE, analysis of occupational exposure scenarios (OES) indicated that many conditions of use still posed risk concerns even with the application of respirators with APF 25 or 50 (Ref. 1). Because of the uncertainty regarding the feasibility of exposure reductions through engineering controls alone, EPA determined that a PCE VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 WCPP ECEL, which would be accompanied by monitoring requirements in tandem with the implementation of engineering controls, administrative controls, and/or PPE as elements of the program, as appropriate, would more successfully reduce exposure so that the unreasonable risk is addressed. Additionally, relying primarily on respirators and gloves to reduce exposures does not consider other more protective controls in the hierarchy, including elimination, substitution, engineering controls, and administrative controls. For occupational conditions of use where compliance with the PCE WCPP ECEL and DDCC is unlikely to be successful, in most cases prohibitions (rather than prescribed controls) would be more appropriate to ensure that PCE does not present unreasonable risk under the conditions of use. However, based on the 2020 Risk Evaluation for PCE, EPA considered the industrial and commercial use in laboratory chemicals as a strong candidate for prescriptive controls. While inhalation exposures from the industrial and commercial use of PCE as a laboratory chemical did not drive the unreasonable risk determination for PCE, EPA’s risk estimates were predicated on its finding that expected safety practices of using PCE in small amounts under a fume hood reduce the potential for inhalation exposures in laboratory settings. To codify assumptions made in the 2020 Risk Evaluation for PCE regarding the use of fume hoods in laboratory settings, EPA is proposing to require fume hoods in laboratory settings that use PCE. This proposed requirement would protect potentially exposed persons in laboratory settings by ensuring that good laboratory practices that reduce the potential for inhalation exposures are consistently applied. Additionally, the 2020 Risk Evaluation for PCE determined that dermal exposures from the industrial and commercial use of PCE as a laboratory chemical drive the unreasonable risk determination for PCE, and analysis in the 2020 Risk Evaluation for PCE indicated that there would still be risk concerns even if chemically resistant gloves are used in combination with specific activity training for tasks where dermal exposure can be expected to occur. However, as described earlier, the 2020 Risk Evaluation for PCE identifies several uncertainties regarding the use of the dermal exposures modeled. For example, the 2020 Risk Evaluation for PCE does not consider the frequency, type, and effectiveness of gloves or other PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 types of PPE used in laboratory settings. In consideration of the whole of the 2020 Risk Evaluation for PCE, including these uncertainties, EPA has preliminarily determined that preventing direct dermal contact with PCE through dermal PPE which covers any exposed skin and PPE training for the industrial and commercial use in laboratory chemicals would address the unreasonable risk from dermal exposure driven by this condition of use for potentially exposed persons. EPA is requesting comment on whether preventing dermal contact with PCE through dermal PPE and training would adequately address the unreasonable risk from dermal exposures for the industrial and commercial use in laboratory chemicals. Additionally, most laboratories are regulated by OSHA under 29 CFR 1910.1450 requirements for occupational exposure to hazardous chemicals in laboratories, and therefore may be more conducive to the implementation of engineering controls such as fume hoods to evacuate vapors and to the proper use and implementation of a dermal PPE program to adequately reduce overall exposure to PCE. The industrial and commercial use of PCE as a laboratory chemical would be necessary to provide for the analysis of monitoring samples required under the ECEL under this proposed regulation. For certain occupational conditions of use, prescribed engineering controls, administrative controls, and PPE were considered as part of the alternative regulatory action and are described in more detail later in this unit and in Unit IV.B. 2. Alternative Regulatory Actions EPA acknowledges that, for some of the occupational conditions of use that it is proposing to prohibit, there may be some activities or facilities that could conceivably implement requirements under a PCE WCPP to ensure that exposure remain below an ECEL and prevent direct dermal contact with PCE. In some cases, they may be able to undertake more extensive risk reduction measures than EPA currently anticipates. Therefore, as a primary alternative regulatory action, described in Unit IV.B., EPA is considering and requesting comment on a PCE WCPP— including requirements to ensure exposures remain below an ECEL and prevent direct dermal contact—for some conditions of use of PCE that would be prohibited under the proposed regulatory action. For those conditions of use that would be subject to the PCE WCPP under the primary alternative regulatory action, but not the proposed E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules regulatory action, EPA was not able to identify reasonably available information such as monitoring data or detailed activity descriptions to indicate with certainty that relevant regulated entities for these conditions of use could mitigate identified unreasonable risk through a PCE WCPP. Due to this uncertainty, EPA is requesting comment on the primary alternative regulatory action and in particular the likelihood of successful compliance with a PCE WCPP, as described in Unit IV.A., for the conditions of use listed for the primary alternative regulatory action of PCE WCPP in Unit IV.B. EPA understands that some of the workplaces engaged in a condition of use may already have stringent engineering controls, administrative controls, and PPE in place to reduce inhalation and dermal exposures to PCE. As part of the alternative regulatory action, EPA considered prescribed engineering controls, administrative controls, and PPE for some occupational conditions of use. In contrast to the proposed nonprescriptive requirements of the WCPP where regulated entities would have flexibility to select controls in accordance with the hierarchy of controls to comply, EPA understands that requiring specific prescriptive controls for certain occupational conditions of use may provide greater certainty to some facilities that they are addressing the unreasonable risk. However, as summarized in this unit, EPA has uncertainty regarding the feasibility of exposure reductions through specified engineering controls, administrative controls, and/or PPE to address unreasonable risk across all workplaces engaged in certain conditions of use. Prescribing specific engineering controls, administrative controls, or PPE does not consider distinctions in processes, equipment, or workplace layout in all facilities, which may result in varying levels and types of controls needed to reduce inhalation exposures to below the ECEL or to eliminate direct dermal contact. Additionally, as described in Unit V.A.1.b., there is a degree of uncertainty regarding applicability of respirators, including their feasibility and consistency of proper use, especially when exposure monitoring is not regularly conducted. However, as part of the primary alternative regulatory action, EPA is considering PPE and soliciting comment on prescribing specific engineering and administrative controls for some occupational conditions of use. In the 2020 Risk Evaluation for PCE, EPA identified PPE VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 that could reduce exposures and is therefore considering requiring PPE, including respiratory protection and dermal protection, as part of the primary alternative regulatory action for those conditions of use where the proposed regulatory action is a PCE WCPP. Turning to the use of PPE, however, does not consider other more preferable controls in the hierarchy of controls, including elimination, substitution, engineering, and administrative controls. As part of the primary alternative regulatory action, EPA is soliciting 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. While the use of dermal PPE is typical for the use of PCE as a laboratory chemical, EPA recognizes the potential for there to be other exposure controls that could prevent direct dermal contact in a laboratory setting. Therefore, as part of the primary alternative regulatory action, EPA is considering implementation of DDCC as part of a PCE WCPP for the industrial and commercial use of PCE as a laboratory chemical. Similarly, EPA understands there may be exposure controls other than a fume hood that could reduce inhalation exposures in a laboratory setting and is therefore considering an ECEL as part of a PCE WCPP for the industrial and commercial use of PCE as a laboratory chemical. EPA also considered proposing a TSCA section 6(g) time-limited exemption for conditions of use that are critical to national security and infrastructure. Based on reasonably available information, and as described earlier in Unit IV.B.2.b, EPA has analyzed the need for an exemption and has found that a TSCA section 6(g) exemption may be warranted under the second alternative regulatory action for the industrial and commercial use in maskant for chemical milling and for the industrial and commercial use in vapor degreasing if the workplaces engaged in that condition of use cannot meet the requirements of the proposed regulatory action (PCE WCPP) or primary alternative regulatory action (prescriptive controls) such that those conditions of use would no longer drive the unreasonable risk. A section 6(g) exemption may mean that the unreasonable risk will not be fully addressed. Note that EPA’s second alternative regulatory action endeavors to ensure that worker protections are in place to the extent practicable and that EPA is required to have a time limited PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 39697 requirement for any exemptions granted under TSCA section 6(g), necessitating revisiting the need and justification for any exemption beyond the initial timeframe. Details of the primary alternative regulatory action and second alternative regulatory action are described in more detail in Unit IV.B. 3. Risk Management Requirements Considered but not Proposed Since it is unlikely that all industrial or commercial facilities with occupational exposures to PCE would be able to implement a WCPP or prescriptive controls, EPA also examined the extent to which a pointof-sale self-certification requirement in order to purchase and subsequently use PCE would further ensure that only facilities able to implement and comply with a WCPP or prescriptive controls are able to purchase and use PCE, and self-certify to that. Under a selfcertification requirement, entities would submit a self-certification to the distributor or retailer each time PCE is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP or required prescriptive controls to control exposures to PCE; the self-certification would be signed and presented by a person authorized to do so by the facility owner or operator. Copies of the self-certification would be maintained as records by both the owner or operator and the distributor or retailer where PCE was purchased. However, because of the number and types of entities where users can obtain PCE or PCE-containing products, EPA does not believe the added requirement and subsequent burden of a point-of-sale selfcertification requirement for the use of PCE would be an effective tool for preventing facilities that may be unable to comply with the WCPP or prescriptive controls of this proposed rulemaking from accessing PCE or PCEcontaining products. As such, EPA is not proposing a self-certification requirement as an additional component of the requirements for addressing the unreasonable risk of occupational exposures to PCE. However, EPA is requesting comment on whether to include a self-certification requirement for purchasing PCE or PCE-containing products. For example, EPA is interested in learning if, for distributors and retailers, such a self-certification requirement would provide greater certainty that any sale of PCE or PCEcontaining products would be for uses that are not prohibited and are to a facility implementing the WCPP or required prescriptive controls. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39698 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules Also, although NIOSH recognizes PCE as an eye irritant (Ref. 67), EPA is not proposing requirements for eye protection from PCE, because eye irritation or injury is not a component of the unreasonable risk EPA has determined is presented by PCE. In considering prescriptive controls as a regulatory action described in this unit to address the unreasonable risk driven by dry cleaning conditions of use, EPA examined monitoring data from New York State Department of Environmental Conservation (NYSDEC) inspections reports for the years 2013– 2015 submitted in July 2020 during the public comment period for the draft 2020 Risk Evaluation for PCE. Previously, EPA rated this information as unacceptable for use in the final 2020 Risk Evaluation for PCE due to lack of critical metadata on sample type and sample duration (Refs. 68, 69). However, during risk management, stakeholders confirmed the missing metadata is short-term duration area monitoring (Refs. 70, 71). EPA analyzed the data to help identify how certain controls may show reductions of PCE concentration in ambient air in air monitoring data and reduce risk from inhalation exposures for PCE dry cleaning (Ref. 45). The analysis of the data show that while certain engineering controls such as 4th generation machines and a vapor barrier room result in lower air concentration of PCE based on area monitoring results, the overall statistics of the data show that PCE air concentrations are generally in exceedance of the ECEL of 0.14 ppm as an 8-hour TWA. It should be noted that there are limitations and uncertainties in using area monitoring data to estimate worker exposure. Based on the results of this analysis and the uncertainties of the data, EPA reasoned that prescriptive engineering controls of requiring 4th generation machines or requiring a vapor barrier room do not adequately address the unreasonable risk driven by inhalation exposures to workers from the industrial and commercial uses of PCE in dry cleaning. An industry stakeholder submitted additional NYSDEC inspection reports for the years 2018–2019 in November 2021. EPA considered the NYSDEC 2018–2019 inspection reports in the Economic Analysis to estimate the age of dry cleaning machines and how much PCE each machine typically uses in a year (Ref. 3). In place of other regulatory actions, EPA considered limiting the weight fraction of PCE in products and formulations to address the unreasonable risk. As described in Unit V.A.1.a., EPA determined that the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 unreasonable risk from PCE would not be driven by use of products containing PCE at less than 0.1% by weight. Therefore, EPA is proposing a de minimis level for products containing PCE at levels of less than 0.1% to account for impurities that do not drive the unreasonable risk., as described in Unit IV.A.1.d. However, for most industrial/commercial and consumer conditions of use, the concentration limit of less than 0.1% is so low that it is highly unlikely that PCE would still serve its functional purpose in the product or formulation. EPA thus concluded that a weight fraction would essentially function as a prohibition for most industrial/commercial and consumer conditions of use. EPA therefore did not propose a weight fraction for industrial/commercial and consumer conditions of use. For the industrial and commercial use in solvent-based adhesives and sealants, EPA identified several products available on the market at concentrations of PCE between 0.1% and 1% by weight (Ref. 1). As part of the primary alternative regulatory action, EPA would set a concentration limit of PCE in adhesive and sealant products for industrial and commercial use to 1%, as described in Unit IV.B.1.c. 4. Additional Considerations After considering the different regulatory options under TSCA section 6(a), alternatives (described in Unit V.B.), compliance dates, and other requirements under TSCA section 6(c), EPA developed the proposed regulatory action described in Unit IV.A. to address the unreasonable risk from PCE to the extent necessary. To ensure successful implementation of this proposed regulatory action, EPA considered other requirements to support compliance with the proposed regulations, such as requiring monitoring and recordkeeping to demonstrate compliance with the PCE WCPP and downstream notification regarding the prohibition on manufacturing, processing, distribution in commerce, and use of PCE, including products containing PCE. These proposed requirements are described in Unit IV.A. As required under TSCA section 6(d), any rule under TSCA section 6(a) must specify mandatory compliance dates, which shall be as soon as practicable with a reasonable transition period, but no later than 5 years after the date of promulgation of the rule (except in the case of a use exempted under TSCA section 6(g) or for full implementation of ban or phaseout requirements). These compliance dates are detailed in Unit PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 IV.A. and IV.B. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. Following Panel recommendations in the SBAR report, and described in Unit IV., EPA considered reasonable compliance timeframes in response to SER input and other appropriate factors, such as the average projected useful lifespan of dry cleaning machines, capital costs for new equipment, and ongoing regulations and rulemakings, including the proposed amendments to the PCE dry cleaning NESHAP (January 5, 2022; 87 FR 421) (Ref. 33). Additionally, following Panel recommendations in the SBAR report, EPA considered compliance timelines based on the availability of technically and economically feasible alternatives, as well as any information provided by other agencies that set requirements for certification or standards relevant to degreasing, parts cleaning, or other uses of PCE. Following Panel recommendations in the SBAR report, EPA is requesting comment on any additional appropriate factors for identifying reasonable compliance timeframes and how to weigh the factors for dry cleaning and other industries, as well as differing compliance or reporting requirements or timetables that account for the resources available to small entities. B. Consideration of Alternatives in Deciding Whether To Prohibit or Substantially Restrict PCE Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must consider, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. To that end, in addition to an Economic Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using reasonably available information (Ref. 56). For this assessment, EPA identified and analyzed alternatives to PCE in products relevant to industrial, commercial, and consumer conditions of use proposed to be prohibited or restricted, even if such restrictions are not anticipated to substantially prevent the condition of use. Based on reasonably available information, E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules including information submitted by industry, EPA understands viable alternatives to PCE may not be available for several conditions of use—for example, the industrial and commercial use in maskant for chemical milling and for the industrial and commercial use in vapor degreasing for certain applications (Refs. 54, 57, 58)—and considered that information to the extent practicable in the development of the regulatory options as described in Unit III.B.3. For some conditions of use, EPA was unable to identify products currently available for sale that contain PCE. EPA is soliciting comments on whether there are products in use or available for sale relevant to these conditions of use that contain PCE at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of PCE. These conditions of use are detailed in the Alternatives Assessment (Ref. 56). For conditions of use for which products currently containing PCE were identified, EPA identified several hundred commercially available alternative products that do not contain PCE, and listed in the Alternatives Assessment, to the extent practicable, their unique chemical components, or ingredients. For each of these chemical components or ingredients, EPA identified whether it functionally replaced PCE for the product use and screened product ingredients for human health and environmental hazard, as well as identified flammability and global warming potential where information was reasonably available (Ref. 56). EPA then assigned a rating to the human health and environmental hazards, using a methodology described in the Alternatives Assessment document. In general, EPA identified products containing ingredients with a lower hazard screening rating than PCE for certain endpoints, while some ingredients presented higher hazard screening ratings than PCE (Ref. 56). These alternative hazard screening ratings are described in detail in the Alternatives Analysis grouped under common product use categories (Ref. 56). Additionally, based on input provided by SERs during the SBAR Panel, EPA understands that some available alternatives may present problems for certain users. For example, SERs identified concerns with waterbased alternatives such as potential termite and mold damage to wood in buildings or water supply limitations due to a drought. SERs also identified concerns with alcohol-based VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 alternatives that present a fire risk, and which may require users to acquire certain permits or comply with restrictions set by State and local agencies, including fire departments. Information regarding potential problems with available alternatives as indicated by SERs during the SBAR Panel is outlined in the SBAR Panel Report (Ref. 33). Following Panel recommendations in the SBAR report, EPA requests public comment about the feasibility of use of alternatives to PCE and their availability for conditions of use that drive the unreasonable risk. In deciding whether to propose prohibition or other significant restrictions on a condition of use of PCE and in proposing an appropriate transition period for any such action, EPA has therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use proposed to be prohibited or restricted, would be reasonably available as a substitute when a proposed prohibition or other significant restriction would become effective. EPA is additionally requesting comment on the Alternatives Assessment as a whole. VI. TSCA Section 6(c)(2) Considerations A. Health Effects of PCE and the Magnitude of Human Exposure to PCE EPA’s analysis of the health effects of PCE and the magnitude of human exposure to PCE are in the 2020 Risk Evaluation for PCE (Ref. 1). A summary is presented here. The 2020 Risk Evaluation for PCE identified potential health effects of PCE including non-cancer adverse health effects such as neurotoxicity and central nervous system effects, kidney and liver effects, immune system toxicity, reproductive toxicity, and developmental toxicity and cancer hazards from carcinogenicity as well as genotoxicity. Among the non-cancer adverse health effects, EPA identified visual deficits indicative of neurotoxicity as a primary effect of PCE in humans following acute and chronic inhalation and dermal exposures. Identified symptoms of neurotoxicity include color confusion, changes in visual contrast detection, and alteration of visual-spatial function. Impaired visual and cognitive function and diminished color discrimination are the most sensitive adverse effects driving the unreasonable risk of PCE exposure. Additionally, the 2020 Risk Evaluation for PCE identified that PCE exposure is associated with several PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 39699 types of cancer, including liver tumors, brain gliomas, kidney cancer, and testicular cancer. By the criteria presented in EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 41), PCE is characterized as ‘‘likely to be carcinogenic to humans by all routes of exposure’’ based on conclusive evidence in mice and rats and suggestive evidence in humans. Other adverse health effects identified in the 2020 Risk Evaluation for PCE identified include central nervous system depression, kidney nephrotoxicity and proximal tubule nuclear enlargement, liver necrosis and extreme dilation of blood or lymph vessels, reduced sperm quality, reduced red blood cells and hemoglobin, increased immune cells, decreased fetal/ placental weight, developmental neurotoxicity, and skeletal effects from chronic exposures (Ref. 1). Regarding the magnitude of human exposure, one factor EPA considers for the conditions of use that drive unreasonable risk is the size of the exposed population which, for PCE, EPA estimates is 67,675 workers and 22,090 ONUs (Ref. 3). The number of consumers that use the approximately 115 types of products containing PCE each year is unknown. For the conditions of use that drive the unreasonable risk for PCE, PESS include workers, ONUs, consumer users, and bystanders to consumers using products containing PCE. Children of workers present at dry cleaners are also a PESS group exposed to PCE during industrial and commercial use of PCE in dry cleaning and spot cleaning. In addition to workers, ONUs, consumers, and bystanders to consumer use directly exposed to PCE, EPA recognizes there is exposure to the general population from air and water pathways for PCE. As mentioned in Unit II.D., EPA has separately conducted a screening approach to assess whether there may be potential risks to the general population from these exposure pathways. While the use of this screening approach indicates that EPA is not able to find that there are no potential risks to fenceline communities, the screening approach was not designed to facilitate the making of an unreasonable risk determination for these communities. This unit summarizes the results of that fenceline analysis. Although EPA is not making a determination of unreasonable risk based on the fenceline screening analysis, the proposed regulatory action described in Unit IV. is expected to reduce the risks identified in the screening approach. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39700 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules As described in Unit II.D., EPA’s analysis methodology was presented to the SACC peer review panel in March 2022, and EPA plans to consider SACC feedback (including the SACC recommendation to EPA to consider multiple years of release data to estimate exposures and associated risks) and make decisions regarding how to assess general population exposures in upcoming risk evaluations, such as for the 1,4-dioxane supplement, the forthcoming 20 High Priority Substances, and manufacturer-requested risk evaluations. For PCE, EPA recognizes that a key input into the fenceline analysis for the ambient air pathway was data on releases from the most recent Toxics Release Inventory (TRI) reporting year and that the use of more than one year of data could result in different conclusions. Accordingly, in this unit EPA presents the results of its water pathway fenceline analysis based on PCE releases to water and its ambient air pathway fenceline analysis based on PCE releases reported to TRI over a single reporting year as well as over multiple years (Refs. 72, 73). EPA’s fenceline analysis for the air pathway for PCE indicates that EPA is not able to conclude that there are no potential risks to fenceline communities, described further in this unit. Additionally, based on the fenceline analysis for the ambient air pathway for PCE, including the strengths, limitations, and uncertainties associated with the information used to inform the analysis, EPA is unable to determine with this analysis whether those risks drive the unreasonable risk of injury to health presented by PCE. Standard cancer benchmarks used by EPA and other regulatory agencies are an increased cancer risk above benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 (i.e., 1 × 10¥6 to 1 × 10¥4) depending on the subpopulation exposed (see, e.g., EPA’s interpretation set forth in 54 FR 38044 (Sept. 14, 1989) which discusses the use of benchmarks for purposes of Section 112 of the Clean Air Act (CAA); see also EPA’s interpretation of the upper bound of acceptable risk and the preferred benchmark described in the Letter of Concern regarding EPA Complaint Nos. 01R–22–R6, 02R–22–R6, and 04R–22 –R6 see page 3 footnotes 5 and 6 and page 6 (Ref. 74)). In this fenceline analysis for the ambient air pathway for PCE, estimates of risk to fenceline communities were calculated using 1 × 10¥6 as the benchmark for cancer risk in fenceline communities. While EPA is unable to determine, based on the screening level fenceline analysis, VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 whether risks to the general population drive the unreasonable risk, as a matter of risk management policy EPA considers the range of 1 × 10¥6 to 1 × 10¥4 as the appropriate benchmark for increased cancer risk for the general population, including fenceline communities. It is preferable to have the air concentration of PCE result in an increased cancer risk closer to the 1 × 10¥6 benchmark, with the 1 × 10¥4 benchmark generally representing the upper bound of acceptability for estimated excess cancer risk. The benchmark value is not a bright line, and the Agency considers a number of factors when determining unreasonable risk, such as the endpoint under consideration, the reversibility of effect, and exposure-related considerations (e.g., duration, magnitude, or frequency of exposure, or population exposed). In this unit, EPA presents the results of its ambient air pathway fenceline analysis and the uncertainties associated with the analysis. EPA also describes how the proposal to prohibit the manufacturing (include importing), processing, and distribution in commerce of PCE for most industrial and commercial use and all consumer use, and to prohibit most industrial and commercial use of PCE, is expected to reduce the potential risks identified in the screening analysis to any general population or fenceline communities close to facilities engaging in PCE use. This unit also describes how EPA believes the proposed WCPP requirements may reduce exposures to the general population for facilities identified in the fenceline analysis with expected exposures to fenceline communities that are associated with conditions of use EPA is not proposing to prohibit. EPA therefore does not intend to revisit the air pathway for PCE as part of a supplemental risk evaluation. There are some uncertainties associated with the fenceline analysis for the air pathway for PCE. The TRI dataset used for the single- and the multi-year fenceline analysis and land use analysis does not include actual release point locations which can affect the estimated concentrations at varying distances modeled. To identify the release location for each facility, EPA used a local-coordinate system based on latitude/longitude coordinates reported in TRI. The latitude/longitude coordinates may represent the mailing address location of the office building associated with a very large facility or some other area of the facility rather than the actual release location (e.g., a specific process stack). This discrepancy between the coordinates reported in TRI PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 and the actual release point could result in an exposure concentration that does not represent the actual distance where fenceline communities may be exposed. The fenceline analysis also evaluated the most ‘‘conservative exposure scenario’’ that consists of a facility that operates year-round (365 days per year, 24 hours per day, 7 days per week) in a South Coastal meteorologic region and a rural topography setting (Ref. 73). Therefore, the modeled exposures to receptors may be overestimated if there are fewer exposure days per year or hours per day. Additionally, the ambient air fenceline analysis organizes facilities and associated risks by OES and generally crosswalks each OES with the associated condition of use of PCE (Ref. 73). For some OES, EPA identified the associated conditions of use to the category level in the December 2020 Risk Evaluation for PCE but was unable identify to the conditions of use to the subcategory level due to limited information on activities and use of PCE reported under TRI. Therefore, some OES indicating increased cancer risk from ambient air exposures to PCE in the air fenceline analysis may be associated with one or more conditions of use of PCE. EPA’s single year fenceline analysis for the ambient air pathway, based on methods presented to the SACC, evaluated PCE releases reported to TRI over the 2019 reporting year. This single year fenceline analysis identified 65 facilities with some indication of releases and potential exposure with associated cancer risk to receptors within select distances evaluated from 5 to 1,000 meters from the respective releasing facility. Separately, following SACC feedback, EPA applied a slightly modified pre-screening methodology to evaluate 6 years of PCE release data (2015 through 2020 TRI data as well as the 6-year average of that data) rather than a single year of data for facilities with reported releases in TRI. The multi-year fenceline analysis identified 30 facilities with some indication of releases and potential exposures and associated cancer risk at a distance of 100 meters from the releasing facility. Based on the multi-year fenceline analysis, 12 of these 30 facilities either had risks above the benchmark for cancer at distances farther out to 100 meters when compared to the single year analysis or are facilities that were not captured in the single-year analysis (e.g., did not report in 2019 TRI). Although the multi-year analysis identified several additional facilities with risk estimates above the benchmark for cancer farther out when E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules compared to the single year analysis or that were not captured in the single-year analysis, the results of overall risk profiles (i.e., OES and corresponding conditions of use with risk estimates above the benchmark for cancer at the distances evaluated) for the single year and multi-year fenceline analyses are the same. While the fenceline analysis identified facilities with some indication of releases and potential exposure with associated increased cancer risk that exceeds the 1 × 10¥6 benchmark at a distance of 100 meters from the releasing facility, the analysis did not identify any facilities exceeding the 1 × 10¥4 benchmark; the highest risk estimate is in the 1 × 10¥5 range (Ref. 73). EPA conducted a land use analysis to determine if EPA can reasonably expect an exposure to fenceline communities to occur within the modeled distances for facilities where there was an indication of risk in the single year or multi-year fenceline analysis. This review consisted of a visual analysis using aerial imagery and interpreting land/use zoning practices around the facility to identify where residential, industrial/ commercial businesses, or other public spaces are present within those radial distances indicating risk (as opposed to uninhabited areas), as well as whether the radial distances lie outside the boundaries of the facility. The land use analysis of the 65 facilities indicating risk in the single-year fenceline analysis identified 24 facilities with expected exposure to fenceline communities. The land use analysis of the 12 additional facilities indicating risk in the multiyear fenceline analysis (i.e., facilities where risk estimates were above the benchmark for cancer at distances farther out when compared to the single-year analysis or facilities that were not captured in the single year analysis) identified 5 additional facilities with expected exposure to fenceline communities. Overall, the land use analysis identified a total of 29 facilities, representing eight OES, with expected exposure to fenceline communities. Those eight OES include: maskant for chemical milling; incorporation into formulation, mixture, or reaction product; industrial processing aid; metalworking fluids; other industrial uses—textile processing; degreasing (batch open-top degreasing; batch closed-loop degreasing; conveyorized vapor degreasing; web vapor degreasing; cold cleaning); manufacturing; and processing as a reactant (Ref. 73). Under the proposed regulatory action described in Unit IV.A., all of the conditions of use associated with the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 metalworking fluids and other industrial uses—textile processing OES would be prohibited. EPA is also proposing to prohibit the processing into formulation, mixture or reaction product for other chemical products and preparations that may be associated with the facilities for the incorporation into formulation, mixture or reaction product OES; the industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing that may be associated with the facilities for the processing aid OES; and the industrial and commercial use as solvent for cold cleaning that may be associated with the degreasing OES (batch open-top degreasing; batch closed-loop degreasing; conveyorized vapor degreasing; web vapor degreasing; cold cleaning). As a result, exposures to any fenceline communities from these facilities would be addressed under the prohibitions in the proposed rulemaking. The remaining facilities with expected exposure to fenceline communities may be associated with the following conditions of use that EPA is not proposing to prohibit: manufacturing; processing as a reactant/ intermediate; processing into formulation, mixture or reaction product for cleaning and degreasing products; processing into formulation, mixture, or reaction product for paint and coating products; processing into formulation, mixture, or reaction product for adhesives and sealants; industrial and commercial use as solvent for open-top batch vapor degreasing; industrial and commercial use as solvent for closed-loop batch vapor degreasing; industrial and commercial use as solvent for in-line conveyorized vapor degreasing; industrial and commercial use as solvent for in-line web cleaner vapor degreasing; industrial and commercial use in maskants for chemical milling; and industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing. For these conditions of use that may be associated with facilities that indicate expected exposure to fenceline communities, the proposed rule would require strict workplace exposure controls via implementation of a WCPP as described in Unit IV.A.2. Under the proposed WCPP requirements, facilities would need to monitor PCE air concentrations by taking personal breathing zone air samples of potentially exposed persons, which would allow facilities to better understand and manage the total PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 39701 releases of PCE within the facility and potentially stack and fugitive emissions. Furthermore, under the WCPP requirements, facilities would need to evaluate controls to determine how to reduce releases and exposures to potentially exposed persons in the workplace. EPA anticipates that this analysis would help facilities to determine the most effective ways to reduce exposures (including possible engineering controls or elimination/ substitution of PCE) and whether those methods for exposure reduction impact releases, and therefore may reduce the overall risk to fenceline communities. EPA requests comment on whether owners and operators should be required to attest to whether and why the exposure controls they have selected would not result in increased air releases of PCE from the workplace, and keep records of that statement as part of the WCPP exposure control plan. Under the proposed rule, only 17 conditions of use would continue (see Unit IV.C. for a summary). For many of these conditions of use, EPA expects use to decline over time. For example, the manufacturing and processing into formulation, mixture, or reaction product conditions of use can reasonably be expected to decline because, while manufacturing and processing into a formulation, mixture, or reaction product could continue under a WCPP, downstream distribution and use of formulations, mixtures, or reaction products other than for vapor degreasing, chemical milling, adhesives and sealants, petrochemical manufacturing, and laboratory use would be prohibited. Additionally, EPA expects the industrial and commercial use of PCE as a reactant in the generation of HFC–134a and HFC–125 to also 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. HFC–125 and HFC–134a are two of the regulated substances that are subject to the AIM Act phasedown. For all 17 conditions of use that would remain ongoing, the proposed rule would require strict workplace exposure controls via implementation of a WCPP or prescriptive workplace controls for laboratory use, as described in Unit IV.A.1. In the instances where efforts to reduce exposures in the workplace to levels below the ECEL could lead to adoption of engineering controls that ventilate more PCE outside, EPA believes this potential exposure would be limited as a result of the existing NESHAP for PCE for these conditions of use under the CAA. Applicable NESHAP include: 40 CFR E:\FR\FM\16JNP3.SGM 16JNP3 39702 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 part 63, subpart F, Synthetic Organic Chemical Manufacturing Industry; 40 CFR part 63, subpart DD, Off-Site Waste and Recovery Operations; 40 CFR part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part 63, subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part 63, subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR part 63, subpart T, Halogenated Solvent Cleaning, which impose emission standards and work practice requirements reflecting maximum achievable control technologies and generally available control technologies. The CAA required residual risk reviews for standards reflecting maximum achievable control technologies, and technology reviews are required every 8 years for all NESHAP. EPA’s fenceline analysis for the water pathway for PCE, based on methods presented to the SACC, did not find risks from drinking water, incidental oral ingestion of surface water, or incidental dermal exposure to surface water (Ref. 72). EPA therefore does not intend to revisit the water pathway for PCE as part of a supplemental risk evaluation. B. Environmental Effects of PCE and the Magnitude of Exposure of the Environment to PCE EPA’s analysis of the environmental effects of PCE and the magnitude of exposure of the environment to PCE are in the 2020 Risk Evaluation for PCE (Ref. 1). The unreasonable risk determination for PCE is based solely on risks to human health; based on the TSCA 2020 Risk Evaluation for PCE, EPA determined that exposures to the environment did not drive the unreasonable risk. A summary is presented here. The manufacturing, processing, use, and disposal of PCE can result in releases to the environment, including aquatic releases of PCE from facilities that manufacture, use, or process PCE. Fate, exposure, and environmental hazard were evaluated in the 2020 Risk Evaluation for PCE in order to characterize environmental risk of PCE. PCE has low bioaccumulation potential and moderate potential to accumulate in wastewater biosolids, soil, or sediment. Releases of PCE to the environment are likely to volatilize to the atmosphere, where it will slowly photooxidize. It may migrate to groundwater, where it will slowly hydrolyze. Additionally, the bioconcentration potential of PCE is low. Potential effects of PCE exposure described in the literature for aquatic life include mortality, developmental VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 deformities, immobilization, reproductive effects, growth effects, and biomass effects. EPA concluded that PCE poses a hazard to environmental aquatic organisms, including aquatic invertebrates, fish, amphibians, and aquatic plants (algae). For acute exposures, PCE is a hazard to aquatic invertebrates based on immobilization, to fish based on immobilization of midge larvae at 7.0 mg/L, to fish based on mortality of rainbow trout as the most sensitive species with acute toxicity values as low as 4.8 mg/L, and amphibians based on developmental effects to the wood frog as the most sensitive species with acute toxicity values as low as 7.8 mg/L. For chronic exposures, PCE is a hazard to aquatic invertebrates, with a toxicity value of 0.5 mg/L; and a chronic toxicity value of 0.84 mg/L for fish. PCE is also a hazard for green algae with a toxicity value of 3.6 mg/L. EPA incorporated modeled exposure data from the Exposure and Fate Assessment Screening Tool or E–FAST (Ref. 75), as well as monitored data from the Water Quality Portal (Ref. 76), to characterize the exposure of PCE to aquatic species. In the 2020 Risk Evaluation for PCE, the indicators evaluated for risk of injury to the environment include immobilization from acute exposure, growth effects from chronic exposure, and mortality to algae (Ref. 1). Based on the 2020 Risk Evaluation for PCE, EPA did not identify risk of injury to the environment that drive the unreasonable risk determination for PCE. C. Benefits of PCE for Various Uses PCE is a solvent used in a variety of industrial, commercial, and consumer use applications, including as a feedstock in the production of fluorinated compounds, cleaning and degreasing, adhesives and sealants, paints and coatings, lubricants and greases, processing aid, and other uses. The physical and chemical properties of PCE, such as non-flammability, high volatility, low global warming potential, low vapor pressure, high chloride density, high boiling point, and high solvency of oils, waxes, and greases, as well as relatively low cost, make it a popular and effective solvent for many applications (Refs. 1, 77, 78). The largest uses of PCE, by production volume, are processing as a reactant and as a solvent in dry cleaning and vapor degreasing (Ref. 1). Based on the 2020 Risk Evaluation for PCE, nearly 65% of the production volume of PCE is used as an intermediate in industrial gas manufacturing and producing fluorinated compounds. The leading PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 fluorocarbons being produced from PCE are HFC–134a and HFC–125, although a small amount of PCE may be used in the production of CFC–113 for applications vital to U.S. security exempted under Title VI of the Clean Air Act Amendments of 1990 (40 CFR part 82), HCFC–123, and HCFC–124. The second largest use of PCE is as a solvent in dry cleaning facilities. PCE effectively dissolves fats, greases, waxes and oils, without harming natural or humanmade fibers. However, there appears to be a trend towards alternatives to PCE in dry cleaning and the demand for PCE dry cleaning solvents has steadily declined as a result of the improved efficiency of dry cleaning equipment, increased chemical recycling and the popularity of wash-and-wear fabrics that eliminate the need for dry cleaning (Refs. 79, 1). According to the 2020 Risk Evaluation for PCE, the third largest use of PCE is as a vapor degreasing solvent. PCE can be used to dissolve many organic compounds, select inorganic compounds and high-boiling waxes and resins, making it useful for cleaning contaminated metal parts and other fabricated materials (Ref. 79). Based on market research, EPA understands that use of PCE as a vapor degreasing solvent has declined and estimates there are 88 facilities that use PCE for vapor degreasing nationwide (Ref. 3). PCE has many other uses, which, based on the 2020 Risk Evaluation for PCE, collectively constitute about 10% of the production volume (Ref. 1). In petrochemical manufacturing, PCE is used as a chloriding agent for reforming and isomerization catalyst process units, which account for approximately 45% of the gasoline pool in the United States (Refs. 66, 63). The high chloride density of PCE minimizes the amount of chemical needed for catalyst regeneration compared to other chloriding agents and the nonflammability is important for process considerations. PCE is also used in maskant for chemical milling, plating, and anodizing processes in the aerospace (military, commercial, and space) and non-aerospace military industries (Ref. 1), as well as in a mission-critical elastomer adhesive used in human-rated rocket motor assembly (including rocket motor subsystem components such as the rocket motor nozzle assembly) (Ref. 59). E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 D. Reasonably Ascertainable Economic Consequences of the Proposed Rule 1. Likely Effect of the Rule on the National Economy, Small Business, Technological Innovation, the Environment, and Public Health The reasonably ascertainable economic consequences of this proposed rule include several components, all of which are described in the Economic Analysis for this proposed rule (Ref. 3). With respect to the anticipated effects of this proposed rule on the national economy, EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers and did not find that there would be an impact on the national economy (Ref. 3). The economic impact of a regulation on the national economy becomes measurable only if the economic impact of the regulation reaches 0.25% to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is equivalent to a cost of $40 billion to $80 billion. Therefore, because EPA has estimated that the monetized cost of the proposed rule would range from $14.0 million annualized over 20 years at a 3% discount rate and $14.3 million annualized over 20 years at a 7% discount rate, EPA has concluded that this rulemaking is highly unlikely to have any measurable effect on the national economy (Ref. 3). In addition, EPA considered the employment impacts of this proposed rule, and found that the direction of change in employment is uncertain, but EPA expects the short-term and longer-term employment effects to be small. There are an estimated 12,202 small entities affected by the proposed option with a per firm and total estimated cost impact of $850 and $10.4 million, respectively. Of the small businesses potentially impacted by this proposed rule, over 99% are expected to have impacts of less than 1% to their firm revenues, 0.1% are expected to have impacts between 1 and 3% to their firm revenues, and 0.2% are expected to have impacts greater than 3% to their firm revenues. EPA estimates that there are currently 6,000 firms currently using PCE dry cleaning machines, but estimates that only 62 would still be using PCE for dry cleaning by the end of the proposed 10-year phaseout. As described further in the Economic Analysis, EPA believes that almost no new PCE machines have been brought into service in recent years and therefore most existing dry cleaning machines using PCE are old and will no longer be in service by the proposed VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 phaseout date. Based on the estimated revenues per firm presented in Table 3– 1 of the Economic Analysis and the 6,000 estimated number of dry cleaning firms using PCE as dry cleaning solvent (see section 6.1.5 (A) of the Economic Analysis), the total revenue for dry cleaning firms using PCE as dry cleaning solvent is approximately $3.1 billion. According to IRS (2013) data, profit in this sector is about 4.8% of sales, implying that total profit of firms using PCE as dry cleaning solvent is about $148 million. However, EPA has proposed a 10-year phaseout of PCE in dry cleaning and estimates that only about 60 PCE dry cleaning machines would remain at the end of the phaseout (see section 7.7.3. of the Economic Analysis). This suggests that the proposed option would only affect about $31 million of the industry’s total revenue and about $1.5 million of the industry’s profit. Many of these firms would likely choose to purchase nonPCE machines or become drop shops (do dry cleaning at another site) rather than close. A detailed sensitivity analysis of varying assumptions on ages of PCE dry cleaning machines and PCE dry cleaning machine life is provided in section 11 of the Economic Analysis. EPA requests comment on these estimated impacts to the dry cleaning industry, including regarding expected closures. In addition to dry cleaners, additional users of PCE (such as in vapor degreasing) could be strongly impacted because they may have no economical alternative to the use of PCE. With respect to this proposed rule’s effect on technological innovation, EPA expects this rulemaking to spur more innovation than it will hinder. A prohibition or significant restriction on the manufacture, processing, and distribution in commerce of PCE for uses covered in this proposed rule may increase demand for safer chemical substitutes. This proposed rule is not likely to have significant effects on the environment because PCE does not present an unreasonable risk to the environment, though this proposed rule does present the potential for small reductions in air emissions and soil contamination associated with improper disposal of products containing PCE. The effects of this proposed rule on public health are estimated to be positive, due to the reduced risk of cancer and other non-cancer endpoints from exposure to PCE. PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 39703 2. Costs and Benefits of the Proposed Regulatory Action and of the One or More Primary Alternative Regulatory Actions Considered by the Administrator The costs and benefits that can be monetized for this proposed rule are described at length in in the Economic Analysis (Ref. 3). The monetized costs for this proposed rule are estimated to range from $14.0 million annualized over 20 years at a 3% discount rate and $14.3 million annualized over 20 years at a 7% discount rate. The monetized benefits are estimated to be $10.2 to $46.3 million annualized over 20 years at a 3% discount rate and $4.72 million to $29.4 million annualized over 20 years at a 7% discount rate. Costs do not include possible additional costs from prohibition of all uses of PCE (except for petrochemical processing) due to need to switch processes or chemicals. EPA requests comment on costs that may be incurred by firms using PCE products to identify suitable alternatives, test them for their desired applications, learn how to use them safely and effectively, and implement new processes for using the alternative products. EPA considered the estimated costs to regulated entities as well as the cost to administer and enforce alternative regulatory actions. The primary and second alternative regulatory actions are described in detail in Unit IV.B. The estimated annualized costs of the primary alternative regulatory action are $14.5 million at a 3% discount rate and $14.7 million at a 7% discount rate over 20 years (Ref. 3). The estimated annualized costs of the second alternative regulatory action are $17.8 million at a 3% discount rate and $19.5 million at a 7% discount rate over 20 years. The monetized benefits of the primary alternative action are estimated to be $10.2 to $46.2 million annualized over 20 years at a 3% discount rate and $4.71 million to $29.3 million annualized over 20 years at a 7% discount rate (Ref. 3). The monetized benefits of the second alternative action are estimated to be $10.2 to $46.4 million annualized over 20 years at a 3% discount rate and $4.73 million to $29.4 million annualized over 20 years at a 7% discount rate. Costs of the second alternative action do not include possible additional costs from prohibition of non-petrochemical processing and chemical milling uses of PCE. These costs for chemical milling could be significant as there is no alternative to the use of PCE in chemical milling for many users. For vapor degreasing, as described in the Economic Analysis, EPA assumes that E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39704 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules there are alternatives to PCE for all users, although switching to some of these alternatives may be very expensive due to required revalidation and possible equipment changes. At least one user has told EPA that they have no alternative to the use of PCE in closed-loop vapor degreasing and at least one other user has requested a 10year phaseout for the use of PCE in vapor degreasing due to the needs for revalidation and possible equipment changes throughout the supply chain (Ref. 3). This proposal is 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. EPA believes that the balance of costs and benefits of this proposal cannot be fairly described without considering the additional, non-monetized benefits of mitigating the non-cancer adverse effects. These effects may include neurotoxicity, kidney toxicity, liver toxicity, immunological and hematological effects, reproductive effects, and developmental effects. The multitude of adverse effects from PCE exposure can profoundly impact an individual’s quality of life, as discussed in Unit II.A. (overview), III.B.2. (description of the unreasonable risk), VI.A. (discussion of the health effects), and the 2020 Risk Evaluation for PCE. Chronic adverse effects of PCE exposure include both cancer and the non-cancer effects listed above. Acute effects of PCE exposure could be experienced for a shorter portion of life but are nevertheless significant in nature. The incremental improvements in health outcomes achieved by given reductions in exposure cannot be quantified for non-cancer health effects associated with PCE exposure, and therefore cannot be converted into monetized benefits. The qualitative discussion throughout this rulemaking and in the Economic Analysis highlights the importance of these non-cancer effects. These effects include willingness-to-pay to avoid illness, which includes cost of illness and other personal costs such as pain and suffering. Considering only monetized benefits underestimates the impacts of PCE adverse outcomes and therefore underestimates the benefits of this proposed rule. 3. Cost Effectiveness of the Proposed Regulatory Action and of the 1 or More Primary Alternative Regulatory Actions Considered by the Administrator Cost effectiveness is a method of comparing certain actions in terms of the expense per item of interest or goal. A goal of this proposed regulatory VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 action is to prevent unreasonable risk resulting from exposure to PCE. The proposed regulatory action would cost $3.0 million per potential prevented cancer case while the primary alternative regulatory action would cost $3.1 million (using the 3% discount rate) and the second alternative regulatory action would cost $3.8 million to achieve the same goals. At a 7% discount rate, the proposed regulatory action would cost $3.0 million per potential prevented cancer case while the primary alternative regulatory action would cost $3.1 million, and the second alternative regulatory action would cost $4.2 million to achieve the same goals. While the proposed regulatory action is lower in cost compared to the other alternative actions, the difference is small (Ref. 3). VII. TSCA Section 9 Analysis, Section 14, and Section 26 Considerations A. TSCA Section 9(a) Analysis TSCA section 9(a) provides that, if the Administrator determines, in the Administrator’s discretion, that an unreasonable risk may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA, the Administrator must submit a report to the agency administering that other law that describes the risk and the activities that present such risk. Section 9(a) describes additional procedures and requirements to be followed by EPA and the other Federal agency following submission of any such report. As discussed in this unit, for this proposed rule, the Administrator proposes to exercise his discretion not to determine that the unreasonable risk from PCE under the conditions of use may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. In addition, TSCA section 9(d) instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burdens of duplicative requirements. For this proposed rule, EPA has and continues to coordinate with appropriate Federal executive departments and agencies, including OSHA and the Consumer Product Safety Commission (CPSC), to, among other things, identify their respective authorities, jurisdictions, and existing laws with regard to PCE, which are summarized in this unit. OSHA requires that employers provide safe and healthful working conditions by setting and enforcing PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 standards and by providing training, outreach, education and assistance. As described in Unit II.C., OSHA, in 1971, established a PEL for PCE of 100 ppm of air as an 8-hour TWA with an acceptable ceiling concentration of 200 ppm and an acceptable maximum peak above the acceptable ceiling concentration for an eight-hour shift of 300 ppm, maximum duration of 5 minutes in any 3 hours. However, the exposure limits established by OSHA are higher than the exposure limit that EPA determined would be sufficient to address the unreasonable risk identified under TSCA from occupational inhalation exposures associated with certain conditions of use. Gaps exist between OSHA’s authority to set workplace standards under the OSH Act and EPA’s obligations under TSCA section 6 to eliminate unreasonable risk presented by chemical substances under the conditions of use. Health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only ‘‘to the extent feasible.’’ 29 U.S.C. 655(b)(5). To set PELs for chemical exposure, OSHA must first establish that the new standards are economically and technologically feasible (79 FR 61384, 61387, Oct. 10, 2014). But under TSCA section 6(a), EPA’s substantive burden is to demonstrate that, as regulated, the chemical substance no longer presents an unreasonable risk, with unreasonable risk being determined without consideration of costs or other nonrisk factors. Thus, if OSHA were to initiate a new action to lower its PEL, the difference in standards between the OSH Act and TSCA may well result in the OSHA PEL being set at a higher level than the exposure limit that EPA determined would be sufficient to address the unreasonable risk under TSCA. In addition, OSHA may set exposure limits for workers, but its authority is limited to the workplace and does not extend to consumer uses of hazardous chemicals, and thus OSHA cannot address the unreasonable risk from PCE under all of its conditions of use, which include consumer uses. OSHA also does not have direct authority over State and local employees, and it has no authority over the working conditions of State and local employees in States that have no OSHA-approved State Plan under 29 U.S.C. 667. CPSC, under authority provided to it by Congress in the CPSA, protects the public from unreasonable risk of injury or death associated with the use of consumer products. Under the CSPA, CPSC has the authority to regulate PCE in consumer products, but not in other sectors such as automobiles, industrial E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules and commercial products, or aircraft, for example. Further, a consumer product safety rule under the CPSA must include a finding that ‘‘the benefits expected from the rule bear a reasonable relationship to its costs,’’ 15 U.S.C. 2058(f)(3)(E), whereas EPA must apply TSCA risk management requirements to the extent necessary so that the chemical no longer presents unreasonable risk and only consider costs and benefits of the regulatory action to the extent practicable, 15 U.S.C. 2605(a), (c)(2). Additionally, the 2016 amendments to TSCA reflect Congressional intent to ‘‘delete the paralyzing ‘least burdensome’ requirement,’’ 162 Cong. Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as originally enacted, which required EPA to use ‘‘the least burdensome requirements’’ that protect ‘‘adequately’’ against unreasonable risk, 15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under the CPSA must impose ‘‘the least burdensome requirement which prevents or adequately reduces the risk of injury for which the rule is being promulgated.’’ 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at variance with recent revisions to TSCA, affect the availability of action CPSC may take under the Federal Hazardous Substances Act (FHSA) relative to action EPA may take under TSCA. 15 U.S.C. 1262. EPA therefore concludes that TSCA is the only regulatory authority able to prevent or reduce unreasonable risk of PCE to a sufficient extent across the range of conditions of use, exposures and populations of concern. This unreasonable risk can be addressed in a more coordinated, efficient and effective manner under TSCA than under different laws implemented by different agencies. Moreover, the timeframe and any exposure reduction as a result of updating OSHA or CPSC regulations cannot be estimated, while TSCA requires a much more accelerated 2-year statutory timeframe for proposing and finalizing regulatory requirements to address unreasonable risk. Further, there are key differences between the finding requirements of TSCA and those of the OSH Act, CPSA, and FHSA. For these reasons, in the Administrator’s discretion, the Administrator has analyzed this issue and does not determine that unreasonable risk from PCE may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. However, EPA is requesting public comment on this issue (i.e., the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 sufficiency of an action taken under a Federal law not administered by EPA). B. TSCA Section 9(b) Analysis If EPA determines that actions under other Federal laws administered in whole or in part by EPA could eliminate or sufficiently reduce a risk to health or the environment, TSCA section 9(b) instructs EPA to use these other authorities to protect against that risk unless the Administrator determines in the Administrator’s discretion that it is in the public interest to protect against such risk under TSCA. In making such a public interest finding, TSCA section 9(b)(2) states: ‘‘the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk . . . and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.’’ Although several EPA statutes have been used to limit PCE exposure (Ref. 6), regulations under those EPA statutes have limitations because they largely regulate releases to the environment, rather than occupational or consumer exposures. While these limits on releases to the environment are protective in the context of their respective statutory authorities, regulation under TSCA is also appropriate for occupational and consumer exposures and in some cases can provide upstream protections that would prevent the need for release restrictions required by other EPA statutes (e.g., Resource Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)). The primary exposures and unreasonable risk to consumers, bystanders, workers, and ONUs would be addressed by EPA’s proposed prohibitions and restrictions under TSCA section 6(a). In contrast, the timeframe and any exposure reduction as a result of updating regulations for PCE under the CAA, CWA, or RCRA cannot be estimated, nor would they address the direct human exposure to consumers, bystanders, workers, and ONUs from the conditions of use evaluated in the 2020 Risk Evaluation for PCE. More specifically, none of EPA’s other statutes (e.g., RCRA, CAA, CWA) can address exposures to workers and ONUs related to the specific activities that result in occupational exposures, for example those associated with RCRA covered disposal requirements. EPA therefore concludes that TSCA is the most appropriate regulatory authority able to prevent or reduce risks of PCE to a sufficient extent PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 39705 across the range of conditions of use, exposures, and populations of concern. For these reasons, the Administrator does not determine that unreasonable risk from PCE under the conditions of use evaluated in the 2020 TSCA Risk Evaluation for PCE could be eliminated or reduced to a sufficient extent by actions taken under other Federal laws administered in whole or in part by EPA. C. TSCA Section 14 Requirements EPA is also providing notice to manufacturers, processors, and other interested parties about potential impacts to CBI that may occur if this rule is finalized as proposed. Under TSCA section 14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a ban or phase-out of a chemical substance, the protection from disclosure of any CBI regarding that chemical substance and submitted pursuant to TSCA will be ‘‘presumed to no longer apply,’’ subject to the limitations identified in TSCA section 14(b)(4)(B)(i) through (iii). If this rule is finalized as proposed, then pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against protection from disclosure would apply only to information about the specific conditions of use that this rulemaking would prohibit or phase out. Manufacturers or processors seeking to protect such information would be able to submit a request for nondisclosure as provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure would need to be submitted within 30 days after receipt of notice from EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such notice via the Central Data Exchange or CDX. D. TSCA Section 26 Considerations In accordance with TSCA section 26(h), EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science. As in the case of the unreasonable risk determination, risk management decisions for this proposed rule, as discussed in Unit III.B.3. and Unit V., were based on a risk evaluation that was subject to public comment and independent, expert peer review, and was developed in a manner consistent with the best available science and based on the weight of the scientific evidence as required by TSCA sections 26(h) and (i) and 40 CFR 702.43 and 702.45. In particular, the ECEL value incorporated into the WCPP and de E:\FR\FM\16JNP3.SGM 16JNP3 39706 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 minimis concentration limit are derived from the analysis in the 2020 Risk Evaluation for PCE; they likewise represent decisions based on the best available science and the weight of the scientific evidence (Refs. 10, 45, 53). The ECEL value of 0.14 ppm as an 8hour TWA is based on the chronic noncancer HEC for neurotoxicity identified in the 2020 Risk Evaluation for PCE, which is the concentration at which an adult human would be unlikely to suffer adverse effects if exposed for a working lifetime, including susceptible subpopulations. As discussed in Unit V.A.1., EPA used models from the 2020 Risk Evaluation for PCE to derive the proposed de minimis concentration limit, which represents a level below which EPA would not expect product use to drive unreasonable risk. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models, as applicable, used in EPA’s decisions have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this rulemaking. Additional information on the peer review and public comment process, such as the peer review plan, the peer review report, and the Agency’s response to comments, can be found in EPA’s risk evaluation docket (Docket ID No.: EPA–HQ–OPPT–2016–0732). VIII. Requests for Comment EPA is requesting public comment on all aspects of this proposal, including the proposed and alternative regulatory actions and all individual elements of these, and all supporting analysis. Additionally, within this proposal, the Agency is soliciting feedback from the public on specific issues throughout this proposed rule. For ease of review, this section summarizes those specific requests for comment. 1. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions. 2. EPA is requesting public comment regarding the need for exemptions from the rule (and under what specific circumstances), including exemptions from the proposed regulatory action (e.g., a WCPP) and the primary and second alternative regulatory actions, pursuant to the provisions of TSCA section 6(g). 3. EPA requests comment on all elements of the IRFA, and, in particular, the flexibilities that EPA has identified following input from the SERs during the SBAR process. 4. EPA requests comment on whether EPA should promulgate definitions for VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 the conditions of use covered by the 2020 Risk Evaluation for PCE that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for PCE and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation. 5. EPA requests comment on the impacts, if any, a prohibition on the processing of PCE into a formulation, mixture or reaction product in other chemical products and preparations, or other aspects of this proposal, may have on the production and availability of any pesticide or other substance excluded from the TSCA definition of ‘‘chemical substance.’’ 6. EPA requests comment regarding the number of businesses or other entities that could potentially close as well as associated costs with a prohibition of PCE for certain industrial and commercial conditions of use identified in this unit. 7. EPA requests comment on the proposed compliance dates for prohibitions of PCE manufacturing, processing, distribution in commerce, and use and whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes; comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation. EPA also requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply. 8. EPA requests comment on the amount of time needed, for example, for dry cleaners to transition to an alternative process or solvent. EPA also requests comment regarding the number of entities that could potentially close as well as associated costs with a 10-year phaseout of PCE for use in dry cleaning as identified in this unit. 9. EPA requests comment on allowing a de minimis level of PCE in products (i.e., concentrations less than 0.1% by weight) to account for impurities. 10. EPA is soliciting comment regarding an ECEL action level that is half the ECEL and any associated provisions related to the ECEL action PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 level when the ECEL is significantly lower than the OSHA PEL. 11. EPA is requesting comment on issues around the viability of current analytical methods and detection limits for occupational perchloroethylene sampling and/or monitoring methods. 12. EPA is soliciting comments regarding the timing of the initial exposure monitoring so that it would be representative of all tasks involving PCE where exposures may approach the ECEL. EPA is also soliciting comments regarding use of area sampling instead of personal breathing zone as a representative sample of exposures. 13. EPA requests comment on the timeframes for periodic monitoring outlined in Table 1 of this unit. 14. EPA is soliciting comment on requiring warning signs to demarcate regulated areas, such as the requirements found in OSHA’s General Industry Standard for Beryllium. 15. EPA requests comment on available methods to measure the effectiveness of engineering and administrative controls in preventing or reducing the potential for direct dermal contact to PCE. EPA is also requesting comment on available monitoring methods, such as charcoal patch testing, as feasible or effective methods to measure potential direct dermal contact with PCE. 16. EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA’s General Industry Standard for 1,3-Butadiene, or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA’s General Industry Standard for Benzene. 17. EPA is soliciting comments on the requirements proposed for appropriate PPE selection, the effectiveness of PPE in preventing direct dermal contact with PCE in the workplace, and general absorption and permeation effects to PPE from direct dermal exposure. In addition, EPA understands that some workplaces rinse and reuse PPE after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing certain types of PPE, either gloves or protective clothing and gear. EPA also requests comment on the degree to which additional guidance related to use of PPE might be appropriate. 18. EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules 19. EPA requests comment relative to the ability of owners or operators to conduct initial monitoring within 6 months after date of publication of the final rule in the Federal Register, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit, including establishment of a respiratory protection program and development of an exposure control plan. EPA also requests comment relative to the ability of owners or operators to implement processes for occupational conditions of use which are subject to DDCC requirements within 12 months of publication of the final rule in the Federal Register, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. 20. EPA requests comment on whether it should incorporate in the rule best practices to ensure proper and adequate performance of laboratory fume hoods, such as those identified in OSHA’s 29 CFR 1910.1450, Appendix A National Research Council Recommendations Concerning Chemical Hygiene in Laboratory. Additionally, EPA requests comment relative to the ability of owners or operators to implement laboratory chemical fume hood and dermal PPE related requirements within 12 months of publication of the final rule, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. 21. EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this unit. 22. EPA requests comment on the primary alternative regulatory action (a combination of prohibitions, requirements for a WCPP, and prescriptive controls) and whether any elements of this primary alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. In particular, EPA is requesting comment on the likelihood of successful compliance with a PCE WCPP, as described in Unit IV.A., for the conditions of use listed for the primary alternative regulatory action of PCE WCPP in Unit IV.B. Further, EPA is soliciting 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. EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 to the timelines identified for the proposed regulatory action in Unit IV.A. 23. EPA requests comment on the ways in which PCE may be used in the conditions of use for which the primary alternative regulatory action would require a WCPP, including whether activities may take place in a closed system and the degree to which users of PCE in these sectors could successfully implement an ECEL, DDCC, and ancillary requirements described in Unit IV.A. For the industrial and commercial use in laboratory chemicals, EPA is soliciting comment on non-prescriptive requirements of an ECEL and DDCC as compared to the prescriptive workplace controls of fume hood and dermal PPE EPA is proposing in Unit IV.A.3. 24. Regulated entities would be required to implement an exposure control plan within 18 months after date of publication of the final rule in the Federal Register. EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. 25. EPA is soliciting comment on prescribing specific dermal PPE, such as gloves, for each condition of use that should be considered as EPA develops the final regulatory action. Additionally, EPA is soliciting comment on prescribing specific respirators or APFs for respirators for each condition of use that should be considered as EPA develops the final regulatory action. 26. EPA is requesting comment on specific controls that mitigate the unreasonable risk from PCE and that could be included as part of a prescriptive workplace controls requirement, which could be considered as EPA develops the final regulatory action. Specifically, EPA is soliciting comment on combinations of specific engineering controls, administrative controls, and PPE that would reduce inhalation exposures to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal contact with PCE for all workplaces where such controls would be required. EPA also is soliciting comment on the extent to which such requirements could reduce inhalation exposures to at or below the ECEL of 0.014 ppm as an 8-hour TWA. Additionally, EPA is requesting comment on the compliance timeframe needed to implement engineering controls, administrative controls, and PPE that reduce inhalation exposures to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal contact with PCE for all regulated entities. PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 39707 27. EPA requests comment on a combination of the 1% concentration limit for adhesives and sealants with specific engineering controls, administrative controls, or respiratory protection that would reduce inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-hour TWA. Additionally, EPA is requesting comment on a combination of a concentration limit with WCPP requirements. EPA also requests monitoring data, formulations used, and detailed descriptions of PCE involving activities for the industrial and commercial use in solvent-based adhesives and sealants to determine whether a concentration limit would reduce inhalation exposures such that risks are no longer unreasonable. 28. EPA requests comment on the second alternative regulatory action (a combination of prohibition and a WCPP) and whether any elements of this second alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. 29. EPA requests comments on all aspects of the section 6(g) exemption from the prohibition on industrial and commercial use of PCE in maskant for chemical milling as part of the second alternative regulatory option, including information on the extent to which the industry could meet the requirements of the proposed WCPP or prescriptive controls and whether compliance with specific elements of the proposed WCPP should also be required during the period of the exemption. 30. EPA requests comments on all aspects of the exemption request and proposed exemption from the prohibition on use of PCE in vapor degreasing as part of the second alternative regulatory action, including information on the extent to which this industry could meet the requirements of the proposed WCPP or prescriptive controls and whether compliance with specific elements of the proposed WCPP should also be required during the period of the exemption. 31. EPA is requesting comment on whether to consider a regulatory alternative that would subject more conditions of use to a WCPP, instead of prohibition, than those currently contemplated in the primary alternative regulatory action. EPA also requests monitoring data and detailed descriptions of PCE involving activities for these conditions of use to determine E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39708 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules whether these additional conditions of use could comply with the WCPP such that risks are no longer unreasonable. 32. EPA is requesting comment on whether vapor degreasing of parts and components for non-aerospace applications should also be exempt from prohibition as part of the second alternative regulatory action for the industrial and commercial use of PCE in vapor degreasing. To facilitate EPA’s consideration of exemptions for other sectors, comments in support of additional exemptions should include detailed explanations of why and how long exemptions would be needed. 33. EPA is soliciting comment on whether it should specify the type of vapor degreasing operation, such as closed loop batch vapor degreasing, that would be exempt from prohibition as part of the second alternative regulatory action for the industrial and commercial use of PCE in vapor degreasing for aerospace parts and whether it should consider different exemption timeframes for different types of vapor degreasing operations. 34. Each owner or operator would be required to provide respiratory protection to all potentially exposed persons in the regulated area within 3 months after receipt of the results of any exposure monitoring or within 6 months after date of publication of the final rule in the Federal Register. Regulated entities would be required to implement an exposure control plan within 9 months after date of publication of the final rule in the Federal Register. EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A. 35. EPA is requesting comment on the de minimis concentration limit of PCE in products or formulations. 36. EPA is requesting comment on the extent to which facilities engaged in the industrial and commercial use of PCE as a processing aid in catalyst regeneration in petrochemical manufacturing may already meet the requirements in the proposed and alternative regulatory actions described in Unit IV. to address the unreasonable risk and is soliciting comment on the impact of such requirements on petroleum refining, with special attention to the price of gasoline. 37. EPA is requesting comment on whether preventing dermal contact with PCE through dermal PPE and training would adequately address the unreasonable risk from dermal exposures for the industrial and commercial use in laboratory chemicals. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 38. EPA is requesting comment on whether to include a self-certification requirement for purchasing PCE or PCEcontaining products. 39. As part of the primary alternative regulatory action, EPA is soliciting 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. 40. EPA is soliciting comments on whether, for those product types relevant to industrial, commercial, and consumer conditions of use proposed to be prohibited or significantly restricted where EPA was unable to identify products currently available for sale that contain PCE, there are products in use or available for sale relevant to these conditions of use that contain PCE at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of PCE. 41. EPA is requesting comment on the Alternatives Assessment as a whole. 42. EPA requests comment on whether owners and operators should be required to attest to whether and why the exposure controls they have selected would not result in increased air releases of PCE from the workplace, and keep records of that statement as part of the WCPP exposure control plan. 43. EPA is requesting comment on the estimated economic impacts to the dry cleanining industry, including regarding expected closures. 44. EPA is requesting public comment on an issue raised in its TSCA section 9(a) Analysis (i.e., the sufficiency of an action taken under a Federal law not administered by EPA). 45. EPA requests comments on whether it should incorporate in the rule voluntary consensus standards that meet specified performance criteria for environmental monitoring or measurement and seeks information in support of such comments regarding the availability and applicability of voluntary consensus standards that may achieve the sampling and analytical requirements of the rule in lieu of the proposed approach. 46. Following Panel report recommendations (Ref. 33) and in response to input provided by SERs, EPA is requesting comment on the following topics as outlined in the SBAR Panel Report: • EPA requests public comment on the extent to which a regulation under TSCA section 6(a) could minimize requirements, such as testing and monitoring protocols, recordkeeping, PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 and reporting requirements, which may exceed those already required under OSHA’s regulations for PCE. • EPA requests comment on the methodology and inputs for the ECEL value that are directly derived from the peer reviewed analysis in the December 2020 Risk Evaluation. • EPA requests comment on reasonable compliance timeframes for small businesses. • EPA requests comment on differing compliance or reporting requirements or timetables that account for the resources available to small entities. • EPA requests public comment on specific compliance timeframes for the laundry industry. • EPA requests comment on any additional appropriate factors for identifying reasonable compliance timeframes and how to weigh the factors for dry cleaning and other industries. • EPA requests public comment about the feasibility of entities complying with and monitoring for a potential ECEL of 0.14 ppm. Specifically, EPA aims to obtain more information on potential costs that could be incurred using strategies to meet the requirements of such a standard, such as engineering, administrative, or prescriptive controls and how feasible it would be for entities to implement these strategies in their operations. • EPA requests public comment about the feasibility of the use of alternatives to PCE and their availability for conditions of use that drive the unreasonable risk. • EPA requests public comment on the consideration for a TSCA section 6(g) exemption and alternative compliance timeframes for dry cleaning, including information on whether the specific use may be critical or essential, why alternatives may not be feasible for this condition of use, and the ideal time limit for an exemption. IX. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT. 1. EPA. Risk Evaluation for Perchloroethylene. EPA Document #740– R1–8011. December 2020. https:// www.regulations.gov/document/EPAHQ-OPPT-2019-0502-0058. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules 2. EPA. Final Revised Unreasonable Risk Determination for Perchloroethylene, Section 5. December 2022. 3. EPA. Economic Analysis of the Proposed Regulation of Perchloroethylene. RIN 2070–AK84. June 2023. 4. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last Updated on May 16, 2022. https://www.epa.gov/ chemical-data-reporting/access-cdrdata#2016. 5. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16, 2022. https:// www.epa.gov/chemical-data-reporting/ access-cdr-data. 6. EPA. Regulatory Actions Pertaining to Perchloroethylene. 2022. 7. OSHA. Standard Interpretations: 8-hr total weight average (TWA) permissible exposure limit (PEL). Accessed January 13, 2023. https://www.osha.gov/lawsregs/standardinterpretations/1995-10-063. 8. NIOSH. Hierarchy of Controls. Page last reviewed: August 11, 2022. https:// www.cdc.gov/niosh/topics/hierarchy/. 9. EPA. Perchloroethylene (PCE); Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability. Federal Register (87 FR 76481, December 14, 2022). 10. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational Use of Perchloroethylene. April 15, 2021. https://www.regulations.gov/document/ EPA-HQ-OPPT-2020-0720-0023. 11. Cavalleri et al. Perchloroethylene exposure can induce colour vision loss. Neuroscience Letters 179: 162–166. August 10, 1994. 12. Echeverria et al. A Behavioral Evaluation of PCE Exposure in Patients and Dry Cleaners: A Possible Relationship Between Clinical and Preclinical Effects. JOEM Vol. 37, Number 6, 667–680. June 1995. 13. AFL–CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992). 14. ACGIH. Supplement: Perchloroethylene. CAS: 127–18–4. Copyright 1996. 15. EPA. A Review of the Reference Dose and Reference Concentration Processes. December 2002. https://hero.epa.gov/ hero/index.cfm/reference/details/ reference_id/88824. 16. Cal/OSHA. Hazard Risk Assessment Project for California: Identification of Chemicals of Concern, Possible Risk Assessment Methods, and Examples of Health Protective Occupational Air Concentrations. December 2007. https:// www.cdph.ca.gov/Programs/CCDP,HP/ DEODC/OHB/HESIS/ CDPH%20Document%20Library/ riskreport.pdf. 17. NIOSH. Criteria for a Recommended Standard: Occupational Exposure to Tetrachloroethylene (Perchloroethylene). Page last reviewed: June 6, 2014. https:// www.cdc.gov/niosh/docs/76-185/ default.html. 18. NIOSH. NIOSH Pocket Guide to Chemical Hazards: Tetrachloroethylene. Page last reviewed: October 30, 2019. https:// www.cdc.gov/niosh/npg/npgd0599.html. 19. NIOSH. Appendix A—NIOSH Potential Occupational Carcinogens. https:// VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 www.cdc.gov/niosh/npg/ nengapdxa.html. 20. Executive Order 13990. Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. Federal Register (86 FR 7037, January 25, 2021). 21. Executive Order 13985. Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. Federal Register (86 FR 7009, January 20, 2021). 22. Executive Order 14008. Tackling the Climate Crisis at Home and Abroad. Federal Register (86 FR 7619, February 1, 2021). 23. EPA. EPA Announces Path Forward for TSCA Chemical Risk Evaluations. June 30, 2021. https://www.epa.gov/ newsreleases/epa-announces-pathforward-tsca-chemical-risk-evaluations. 24. SACC. Science Advisory Committee on Chemicals Meeting Minutes and Final Report No. 2022–01. March 15–17, 2022. https://www.regulations.gov/document/ EPA-HQ-OPPT-2021-0415-0095. 25. EPA. Notes from Federalism Consultation on Forthcoming Proposed Rulemakings for Trichloroethylene, Perchloroethylene, and nMethylpyrrolidone under TSCA Section 6(a). July 22, 2021. 26. EPA. Notes from Tribal Consultations on Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE). June 15, 2021 and July 8, 2021. 27. Peter Sinsheimer; Green Analytics. Comments on Environmental Justice Consultation for TSCA PCE Risk Management of Dry Cleaning. August 20, 2021. 28. Hans Kim; AQUA Wet Clean. Letter re: Environmental Justice Consultation USEPA TSCA PCE Risk Management. August 20, 2021. 29. W. Heiger-Bernays and G. Nielsen. Comments on Environmental Justice Consultation #2 for TCE and PCE. July 5, 2021. 30. Martin Argu¨ello; Physicians for Social Responsibility. USEPA EJ Consultation Meeting Comments on PCE and TCE TSCA Regulations August 20, 2021. 31. Sa Liu; School of Health Sciences Purdue University. Letter re: Environmental Justice Consultation on Forthcoming Proposed Rulemakings under TSCA Section 6(a). August 20, 2021. 32. EPA. Notes from Environmental Justice Consultations on Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE). June 16 and July 6, 2021. 33. EPA. Final Report of the Small Business Advocacy Review Panel on EPA’s Planned Proposed Rule Toxic Substances Control Act (TSCA) Section 6(a) Perchloroethylene. February 1, 2023. 34. EPA. Initial Regulatory Flexibility Analysis for Perchloroethylene; Regulation of Perchloroethylene under TSCA § 6(a) Proposed Rule; RIN 2070– AK84. June 2023. 35. EPA. Public Webinar on Perchloroethylene: Risk Evaluation and PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 39709 Risk Management under TSCA Section 6. January 14, 2021. https:// www.regulations.gov/document/EPAHQ-OPPT-2020-0720-0002. 36. EPA. Stakeholder Meeting List for Proposed Rulemaking for Perchloroethylene under TSCA Section 6(a). 37. EPA. 2021 Policy on Children’s Health. October 5, 2021. 38. EPA. Problem Formulation of the Risk Evaluation for Perchloroehtylene (Ethene, 1,1,2,2-Tetrachloro). EPA Document #EPA–740–R1–7017. May 2018. https://www.regulations.gov/ document/EPA-HQ-OPPT-2016-07320080. 39. EPA. Final Risk Evaluation for Perchloroethylene: Supplemental File: Releases and Occupational Exposure Assessment. December 2020. https:// www.regulations.gov/document/EPAHQ-OAR-2005-0155-0565. 40. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane. EPA Document #EPA–740–R–20–005. August 2020. https://www.regulations.gov/document/ EPA-HQ-OPPT-2018-0427-0048. 41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005. https:// www.epa.gov/risk/guidelines-carcinogenrisk-assessment. 42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride. Federal Register (62 FR 1494, January 10, 1997). 43. Tetrachloroethylene Vapor Monitor (OV– 80). https://acsbadge.com/product/ tetrachloroethylene-vapor-monitor-ov80/. 44. OSHA. Recommended Practices for Safety and Health Programs. October 2016. https://www.osha.gov/safetymanagement. 45. EPA. Perchloroethylene (PCE): Risk Management Support Documents. November 18, 2022. 46. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/sites/ default/files/publications/osha3151.pdf. 47. National Research Council. Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards, Updated Version. 2011. https:// www.nationalacademies.org/our-work/ prudent-practices-in-the-laboratory-anupdate. 48. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016. 49. EPA. Meeting with The Chemours Company on Risk Management under TSCA Section 6 and Perchloroethylene. February 23, 2021. https:// www.regulations.gov/document/EPAHQ-OPPT-2020-0720-0008. 50. EPA. Meeting with Honeywell on Risk Management under TSCA Section 6 and Perchloroethylene (PCE). March 25, 2021. https://www.regulations.gov/ document/EPA-HQ-OPPT-2020-07200018. 51. EPA. Perchloroethylene (PCE): Risk Management Support—PCE Adhesive Use. May 24, 2023. 52. EPA. Risk Management for Perchloroethylene Supplemental File: Occupational Risk Calculator. CASRN: 127–18–4. December 2021. E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39710 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules 53. EPA. Risk Management for Perchloroethylene Supplemental File: Consumer Risk Calculator. CASRN: 127– 18–4. March 2021. 54. EPA. Meeting with Spirit AeroSystems on Risk Management under TSCA Section 6 and Perchloroethylene (PCE). March 11, 2021. https://www.regulations.gov/ document/EPA-HQ-OPPT-2020-07200013. 55. IAMAW. Letter to EPA from International Association of Machinists and Aerospace Workers. August 18, 2021. 56. EPA. An Alternatives Assessment for Use of Perchloroethylene RIN 2070–AK84. November 2022. 57. The Boeing Company. Comments Supporting Request for Additional Information on Perchloroethylene (PCE); Rulemaking Under TSCA Section 6(a) May 6, 2022. 58. The Boeing Company. Comments Supporting Request for Additional Information on Perchloroethylene (PCE); Rulemaking Under TSCA Section 6(a). September 23, 2022. 59. NASA. Known Uses of Perchloroethylene. Updated December 14, 2022. 60. Steve Shestag; The Boeing Company. Information on FAA Certification. December 9, 2022. 61. EPA. Meeting with State and Local TSCA Coordination Group on Risk Management under TSCA Section 6 for Perchloroethylene. July 11, 2022. 62. EPA. Meeting with state and local government representatives on Risk Management under TSCA Section 6 for Perchloroethylene. June 17, 2021. 63. EPA. Meeting with Honeywell UOP on Risk Management under TSCA Section 6 for Perchloroethylene (PCE) in Petrochemical Manufacturing. June 9, 2021. 64. AFPM and API. Comment of the American Fuels & Petrochemical Manufacturers and the American Petroleum Institute on Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination Perchloroethylene. August 1, 2022. https:// www.regulations.gov/comment/EPA-HQOPPT-2016-0732-0122. 65. AFPM. AFPM Comments on the Notice— ‘‘Problem Formulations for the Risk Evaluations To Be Conducted for the First Chemical Substances Under the Toxic Substances Control Act, and Application of Systematic Review in TSCA Risk Evaluations; Extension of Comment Period; Tetrachloroethylene (also known as perchloroethylene)’’. August 16, 2018. https:// www.regulations.gov/comment/EPA-HQOPPT-2016-0732-0108. 66. EPA. Meeting with the American Fuel and Petrochemical Manufacturers on Risk Management under TSCA Section 6 for Perchloroethylene. July 29, 2021. 67. NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) Publication No. 2005–149. September 2007. https:// www.cdc.gov/niosh/npg/default.html. 68. HSIA. Comment letter from the Halogenated Solvents Industry Alliance, VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 Inc. on the draft perchloroethylene TSCA risk evaluation. July 6, 2020. https:// www.regulations.gov/comment/EPA-HQOPPT-2019-0502-0053. 69. EPA. Risk Evaluation for Perchloroethylene (Ethylene, 1,1,2,2Tetrachloro) Systematic Review Supplemental File: Data Quality Evaluation of Environmental Releases and Occupational Exposure. CASRN: 127–18–4. April 2020. 70. EPA. Meeting with National Cleaners Association on Risk Management under TSCA Section 6 and Perchloroethylene (PCE). January 28, 2021. https:// www.regulations.gov/document/EPAHQ-OPPT-2020-0720-0006. 71. EPA. Meeting with New York State Department of Environmental Conservation on Risk Management under TSCA Section 6 for Perchloroethylene. June 10, 2021. 72. EPA. Perchloroethylene: Fenceline Technical Support—Water Pathway. October 6, 2022. 73. EPA. Perchloroethylene: Fenceline Technical Support—Air Pathway. December 8, 2022. 74. OEJECR. EPA Complaint Nos. 01R–22– R6–, 02R–22–R6, and 04R–22–R6. October 12, 2022. 75. EPA. Exposure and Fate Assessment Screening Tool Version 2014 (E–FAST 2014). Washington, DC: Office of Pollution Prevention and Toxics. Last updated: February 17, 2022. https:// www.epa.gov/tsca-screening-tools/e-fastexposure-and-fate-assessment-screeningtool-version-2014. 76. National Water Quality Monitoring Council (NWQMC): Water Quality Portal. 2017. https://www.waterqualitydata.us/. 77. William P.L. Carter. Development of the SAPRC–07 Chemical Mechanism and Updated Ozone Reactivity Scales. Center for Environmental Research and Technology, College of Engineering, University of California. Revised January 27, 2010. 78. World Meteorological Organization. Scientific Assessment of Ozone Depletion: 2018. Global Ozone Research and Monitoring Project—Report No. 58. https://ozone.unep.org/sites/default/ files/2019-05/SAP-2018-Assessmentreport.pdf. 79. ATSDR. Toxicological Profile for Tetrachloroethylene. June 2019. https:// wwwn.cdc.gov/TSP/ToxProfiles/ ToxProfiles.aspx?id=265&tid=48. 80. EPA. Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA); Regulation of Perchloroethylene under TSCA Section 6(a). June 2023. 81. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical Methods With Related International Voluntary Consensus Standards. J Occup Environ Hyg. 12(7): D107–15. June 11, 2015. https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4589148/. X. Statutory and Executive Order Reviews Additional information about these statutes and Executive orders can be PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review This action is a ‘‘significant regulatory action’’, as defined under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA submitted this action to OMB for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an economic analysis (Ref. 3) of the potential costs and benefits associated with this action, which is also available in the docket and summarized in Unit VI.D. B. Paperwork Reduction Act (PRA) The information collection activities in this proposed rule have been submitted to OMB for review and comment under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2740.01 (Ref. 80). You can find a copy of the ICR in the docket for this proposed rule, and it is briefly summarized here. There are two primary provisions of the proposed rule that may increase burden under the PRA. The first is downstream notification, which would be carried out by updates to the relevant SDS and which would be required for manufacturers, processors, and distributors in commerce of PCE, who would provide notice to companies downstream upon shipment of PCE about the prohibitions. The information submitted to downstream companies through the SDS would provide knowledge and awareness of the restrictions to these companies. The second primary provision of the proposed rule that may increase burden under the PRA is WCPP-related information generation, recordkeeping, and notification requirements (including development of exposure control plans; exposure level monitoring and related recordkeeping; development of documentation for a PPE program and related recordkeeping; development of documentation for a respiratory protection program and related recordkeeping; development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 implementation documentation, and respirator program documentation; and development of documentation demonstrating eligibility for an exemption from the proposed prohibitions, and related recordkeeping). Respondents/affected entities: Persons that manufacture, process, use, distribute in commerce, or dispose of PCE or products containing PCE. See also Unit I.A. Respondent’s obligation to respond: Mandatory (TSCA section 6(a) and 40 CFR part 751). Estimated number of respondents: 12,091. Frequency of response: On occasion. Total estimated burden: 64,622 hours (per year). Burden is defined at 5 CFR 1320.3(b). Total estimated cost: $7,625,325 (per year), includes $2,753,517 annualized capital or operation and maintenance costs. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. After display in the Federal Register when approved, the OMB control numbers for certain EPA regulations in title 40 of the CFR are listed in 40 CFR part 9 and displayed on the form and instructions or collection portal, as applicable. Submit your comments on the Agency’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB’s Office of Information and Regulatory Affairs using the interface at https:// www.reginfo.gov/public/do/PRAMain. Find this particular ICR by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. OMB must receive comments no later than August 15, 2023. EPA will respond to ICR-related comments in the final rule. C. Regulatory Flexibility Act (RFA) As required by section 609(b) of the RFA, EPA convened a SBAR Panel to obtain advice and recommendations from SERs that potentially would be subject to the rule’s requirements. The SBAR Panel evaluated the assembled materials and small-entity comments on issues related to elements of an initial regulatory flexibility analysis (IRFA). A copy of the full SBAR Panel Report (Ref. 33) is available in the rulemaking docket. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 39711 Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA prepared an IRFA (Ref. 34) that examines the impact of the proposed rule on small entities along with regulatory alternatives that could minimize that impact. The complete IRFA is available for review in the docket and is summarized here. mold cleaners, and other products also account for about half of the affected small entities. EPA also estimates that 69 small entities use PCE in chemical milling, 88 use PCE in recycling and disposal, and 30 incorporate PCE into other formulations, mixtures, and reaction products. 1. Need for the Rule Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines after a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a PESS identified as relevant to the risk evaluation, under the conditions of use, 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. PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020. In addition, in December 2022, EPA issued a revised unreasonable risk determination that PCE as a whole chemical substance presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that PCE no longer presents such risk. 4. Projected Compliance Requirements To address the unreasonable risk EPA has identified, EPA is proposing to: prohibit most industrial and commercial uses and the manufacture (including import), processing and distribution in commerce, of PCE for those uses; prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; prohibit the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 10-year phaseout; require a PCE WCPP, which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact, for certain conditions of use not prohibited; require prescriptive workplace controls for laboratory use; and establish recordkeeping and downstream notification requirements. There are an estimated 12,189 small entities affected by the proposed option with a per firm cost of $715 with a total estimated cost impact of $8.7 million. This includes $6.7 million for WCPP uses, $1.9 million for uses that are prohibited, and $0.1 million for lab uses. EPA is proposing to prohibit most conditions of use. For most other conditions of use that drive the unreasonable risk determination for PCE, EPA proposes to address the unreasonable risk with a PCE WCPP, which would include a combination of requirements to address unreasonable risk driven by inhalation and dermal exposures in the workplace. A PCE WCPP would encompass restrictions on certain occupational conditions of use and could include provisions for an ECEL, DDCC, and ancillary requirements to support implementation of these restrictions. Due to the low exposure level and stringent requirements in the PCE WCPP that would be necessary to address the unreasonable risk from PCE, EPA identified only a relatively small number of conditions of use where the Agency expected a PCE WCPP could be successfully implemented. As described in Unit IV.A., the PCE WCPP would be non-prescriptive, in the sense that regulated entities would not be required to use specific controls prescribed by EPA to achieve the 2. Objectives and Legal Basis Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA 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 section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. EPA has determined through a TSCA section 6(b) risk evaluation that PCE presents an unreasonable risk under the conditions of use. 3. Description and Number of Small Entities to Which the Rule Will Apply The proposed rule potentially affects small manufacturers (including importers), processors, distributors, retailers, users of PCE or of products containing PCE, and entities engaging in disposal. EPA estimates that the proposal would affect approximately 12,202 small entities. Almost half (5,949) of these entities are commercial users of PCE in dry cleaning applications. Users of products containing PCE, including adhesives and sealants, aerosol cleaners/ degreasers, liquid cleaners/degreasers, PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39712 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules exposure concentration limit. Rather, it would be a performance-based exposure limit that would enable owners or operators to determine how to most effectively meet the exposure limit based on conditions at their workplace. A central component of the PCE WCPP is the exposure limit. Exposures remaining at or below the ECEL would address any unreasonable risk of injury to health driven by inhalation exposures for occupational conditions of use. EPA’s proposed requirements include the specific exposure limits that would be required to meet the TSCA section 6(a) standard to apply one or more requirements to the substance so that it no longer presents unreasonable risk, and also include ancillary requirements necessary for the ECEL’s successful implementation as part of a WCPP. EPA is not proposing reporting requirements beyond downstream notification (third-party notifications). Regarding recordkeeping requirements, three primary provisions of the proposed rule relate to recordkeeping. The first is recordkeeping of general records: all persons who manufacture, process, distribute in commerce, or engage in industrial or commercial use of PCE or PCE-containing products must maintain ordinary business records, such as invoices and bills-of-lading related to compliance with the prohibitions, restrictions, and other provisions of the regulation. The second is recordkeeping related to WCPP compliance: under the proposed regulatory action, facilities complying with the rule through WCPP would be required to develop and maintain records associated with ECEL exposure monitoring (including measurements, compliance with Good Laboratory Practice Standards, and information regarding monitoring equipment); ECEL compliance (including the exposure control plan, PPE program implementation, and workplace information and training); DDCC compliance (including the exposure control plan, PPE program implementation, basis for specific PPE selection, occurrence and duration of direct dermal contact with PCE, and workplace information and training); and workplace participation. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP retain compliance records for five years. EPA is also proposing to require specific prescriptive controls for the industrial and commercial use of PCE in laboratory chemicals. To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to PCE VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 a. Classes of Small Entities Subject to the Compliance Requirements The small entities that would be potentially directly regulated by this rulemaking are small entities that manufacture (including import), process, distribute in commerce, use, or dispose of PCE, including retailers of PCE for end-consumer uses. of PCE would be required to implement a WCPP and would have to meet the provisions of the program for continued use of PCE. Entities that would be permitted to continue use of PCE as a laboratory chemical would be required to implement prescriptive workplace controls for laboratory use and would have to meet the provisions of the workplace restrictions for continued use of PCE. A transition to a WCPP or prescriptive workplace controls for laboratory use may require persons with specialized skills such as an engineer or health and safety professional. Instead of implementing the WCPP or workplace controls for laboratory use themselves, entities that use PCE may choose to contract with another entity to do so. Records would have to be maintained for compliance with a WCPP or workplace controls for laboratory use, as applicable. While this recording activity itself may not require a special skill, the information to be measured and recorded may require persons with specialized skills such as an industrial hygienist. b. Professional Skills Needed To Comply Entities that would be subject to this proposal that manufacture (including import), process, or distribute PCE in commerce for consumer use would be required to cease under the proposed rule. The entity would be required to modify their SDS or develop another way to inform their customers of the prohibition on manufacture, processing, and distribution of PCE for consumer use. They would also be required to maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation. These are all routine business tasks that do not require specialized skills or training. Entities that use PCE in any industrial and commercial capacity that is prohibited would be required to cease under the proposed rule. Restriction or prohibition of these uses will likely require the implementation of an alternative chemical or the cessation of use of PCE in a process or equipment that may require persons with specialized skills, such as engineers or other technical experts. Instead of developing an alternative method themselves, commercial users of PCE may choose to contract with another entity to do so. Entities that would be permitted to continue to manufacture, process, distribute, use (with the exception for use as a laboratory chemical), or dispose 5. Relevant Federal Rules Because of its health effects, PCE is subject to numerous state, Federal, and international regulations restricting and regulating its use. The following is a summary of the regulatory actions pertaining to PCE; for a full description see appendix A of the 2020 Risk Evaluation for PCE and the summary in the docket (Ref. 6). EPA has issued numerous rules and notices pertaining to PCE under its various authorities. PCE is a hazardous air pollutant under the CAA (42 U.S.C. 7412(b)(1)). EPA promulgated NESHAP for a number of source-specific categories that emit PCE, including dry cleaning (40 CFR part 63, subpart M) and halogenated solvent cleaning (40 CFR part 63, subpart T). With this proposed rule under TSCA section 6, certain uses and emissions already regulated under these NESHAP would be prohibited while other uses would be subject to a WCPP. Programs within EPA implementing other environmental statutes, including, but not limited to, the RCRA, the Comprehensive Environmental Response, Compensation, and Liability Act, the Safe Drinking Water Act, and the CWA, classify PCE as a characteristic and listed hazardous waste (40 CFR 261.24, 40 CFR 261.31, 40 CFR 261.33), a hazardous substance (40 CFR 302.4), a contaminant subject to National Primary Drinking Water Regulations (40 CFR 141.61), and a toxic pollutant (40 CFR 401.15, 40 CFR part 423, appendix A, 40 CFR 131.36) or the identified for the industrial and commercial use as a laboratory chemical, EPA is proposing to require dermal PPE in combination with comprehensive training for tasks particularly related to the use of PCE in a laboratory setting for each potentially exposed person to direct dermal contact with PCE. Additionally, EPA is proposing to require the use of fume hoods in workplaces engaged in the laboratory chemical condition of use. To support and demonstrate compliance, EPA is proposing that each owner or operator of a laboratory workplace subject to the workplace controls for laboratory use requirements retain compliance records for five years. PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 program requires reportable criteria of releases into the environment involving PCE. While TSCA shares equity in the regulation of PCE, EPA does not anticipate this rulemaking to duplicate nor conflict with the aforementioned programs’ classifications and associated rules. In addition to EPA actions, PCE is also subject to other Federal regulations. Under the OSH Act, OSHA established the PEL for PCE at 100 ppm as an 8-hour TWA with an acceptable ceiling concentration of 200 ppm and an acceptable maximum peak above the acceptable ceiling concentration for an 8-hour shift of 300 ppm, maximum duration of 5 minutes in any 3 hours. However, EPA recognizes that the existing PEL does not eliminate the unreasonable risk identified by EPA under TSCA, and EPA is therefore proposing to apply new, lower exposure thresholds, derived from the TSCA 2020 Risk Evaluation for PCE, while aligning with existing OSHA requirements where possible. For PCE, this approach would eliminate the unreasonable risk driven by certain conditions of use, reduce burden for complying with the regulations, and provide the familiarity of a pre-existing framework for the regulated community. Under the FHSA, visual novelty devices containing PCE are regulated by the CPSC (16 CFR 1500.83(a)(31)). Under the FFDCA, the Food and Drug Administration regulates PCE in bottled water and set the maximum permissible level of PCE in bottled water to 0.005 mg/L (21 CFR 165.110). Under the Atomic Energy Act, the Department of Energy Worker Safety and Health Program requires its contractor employees to use the 2005 ACGIH TLV for PCE, which is 25 ppm (8-hour TWA) and 100 ppm Short Term Exposure Limit. Under the Federal Hazardous Material Transportation Act, the Department of Transportation has designated PCE as a hazardous material, and there are special requirements for marking, labeling, and transporting it (49 CFR part 171, 49 CFR part 172, 40 CFR 173.202, and 40 CFR 173.242). 6. Significant Alternatives to the Proposed Rule EPA analyzed alternative regulatory approaches to identify which would be feasible, reduce burden to small businesses, and achieve the objective of the statute (i.e., applying one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents an unreasonable risk). As described in more detail in Unit V., EPA considered several factors, in addition VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 to identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: the effects of PCE on health and the environment, the magnitude of exposure to PCE of human beings and the environment, the benefits of PCE for various uses, and the reasonably ascertainable economic consequences of the proposed rule. EPA also considered input provided by the SERs in selecting among possible TSCA section 6(a) requirements as part of the proposed regulatory action and alternative regulatory actions, particularly as it related to dry cleaners’ compliance timeframes. Overall, EPA expects few dry cleaning facility closures because EPA estimates that only about 60 PCE machines are expected to be in use at the end of the proposed phaseout period, based on SER input and given the age of the machines and the declining trend of use. Additionally, as s part of this analysis, EPA considered— in addition to prohibition, WCPP, and prescriptive controls described earlier— a wide variety of control measures to address the unreasonable risk from PCE such as weight fractions and a point-ofsale self-certification requirement. EPA’s analysis of these risk management approaches is detailed in Unit V.A.3. In general, EPA determined that these approaches alone would either not be able to address the unreasonable risk, or, in the case of a weight fraction limit, would result in a product containing so little PCE that it would have the effect of a prohibition. Weight Fractions: As discussed in Unit V.A.3., EPA considered limiting the weight fraction of PCE in industrial/ commercial and consumer products and conducted an analysis to estimate to what extent this would reduce risks from conditions of use that drive the unreasonable risk for PCE. EPA determined that the unreasonable risk from PCE would not be driven by use of products containing PCE at less than 0.1% by weight. Therefore, EPA is proposing a de minimis level for products containing PCE at levels of less than 0.1% to account for impurities that do not drive the unreasonable risk., as described in Unit IV.A.1.d. For most industrial/commercial and consumer conditions of use, the weight fraction or concentration identified through this modeling that would address the unreasonable risk through inhalation or dermal pathways was so low that it was highly unlikely that PCE would still serve its functional purpose in the formulation. EPA thus concluded that a weight fraction limit would essentially PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 39713 function as a prohibition yet with a greater amount of uncertainty regarding compliance and no increased benefit to users; it was therefore not a preferred option. For the industrial and commercial use in solvent-based adhesives and sealants, EPA identified several products available on the market at concentrations of PCE between 0.1% and 1% by weight in the 2020 Risk Evaluation for PCE. As part of the primary alternative regulatory action, EPA would set a concentration limit of PCE in adhesive and sealant products for industrial and commercial use to 1%, as described in Unit IV.B.1.c. Point-of-sale self-certification: As discussed in Unit V.A.3., EPA also examined the extent to which a pointof-sale self-certification requirement in order to purchase and subsequently use PCE would further ensure that only facilities able to implement and comply with a WCPP or prescriptive controls are able to purchase and use PCE, and self-certify to that. Under a selfcertification requirement, entities would submit a self-certification to the distributor or retailer each time PCE is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP or required prescriptive controls to control exposures to PCE; the self-certification would be signed and presented by a person authorized to do so by the facility owner or operator. Copies of the self-certification would be maintained as records by both the owner or operator and the distributor or retailer where PCE was purchased. However, because of the number and types of entities where users can obtain PCE or PCE-containing products, EPA does not believe the added requirement and subsequent burden of a point-of-sale selfcertification requirement for the use of PCE would be an effective tool for preventing facilities that may be unable to comply with the WCPP or prescriptive controls of this proposed rulemaking from accessing PCE or PCEcontaining products. As such, EPA is not proposing a self-certification requirement as an additional component of the requirements for addressing the unreasonable risk of occupational exposures to PCE. Prescriptive controls: As discussed in Unit V.A.1., EPA considered prescriptive controls (i.e., engineering or administrative controls, or PPE) and has determined that prescriptive controls may not be able to eliminate unreasonable risk for some conditions of use when used in isolation. In the 2020 Risk Evaluation for PCE, analysis of occupational exposure scenarios (OES) indicated that many conditions of use E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39714 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules still posed risk concerns even with the application of respirators with APF 25 or 50. Because of the uncertainty regarding the feasibility of exposure reductions through engineering controls alone, EPA determined that a PCE WCPP ECEL, which would be accompanied by monitoring requirements in tandem with the implementation of engineering controls, administrative controls, and/or PPE as elements of the program, as appropriate, would more successfully reduce exposure so that the unreasonable risk is addressed. Additionally, relying primarily on respirators and gloves to reduce exposures does not consider other more protective controls in the hierarchy, including elimination, substitution, engineering controls, and administrative controls. For occupational conditions of use where compliance with the PCE WCPP ECEL and DDCC is unlikely to be successful, in most cases prohibitions (rather than prescribed controls) would be more appropriate to ensure that PCE does not present unreasonable risk under the conditions of use. EPA is proposing prescriptive workplace controls for laboratory use to codify assumptions made in the 2020 Risk Evaluation for PCE regarding the use of fume hoods in laboratory settings and because EPA has preliminarily determined that chemically resistant gloves in combination with specific activity training for tasks where dermal exposure can be expected to occur in laboratory settings would address the unreasonable risk resulting from dermal exposures. Additionally, as part of the primary alternative regulatory action, EPA includes certain prescriptive controls (PPE in combination with monitoring, regulated area, and training) for conditions of use for which EPA is proposing WCPP as the regulatory action. As indicated by this overview, and detailed in Unit V.A, in the review of alternatives, EPA determined that some methods either did not effectively eliminate the unreasonable risk presented by PCE or, for many conditions of use, there was a high degree of uncertainty regarding whether compliance with a comprehensive WCPP or prescriptive controls would be possible to adequately protect potentially exposed persons. The primary alternative regulatory action and second regulatory action were considered and found to provide greater uncertainty in addressing the unreasonable risk from PCE under the conditions of use, resulting in EPA’s proposed action. Information on the VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 costs and benefits of the proposed and alternative regulatory actions is available in Chapters 7 and 8 of the Economic Analysis Analysis and analysis on small entity impacts is in Chapter 10 of the Economic Analysis. EPA considered its authority under TSCA section 6(g) to grant a timelimited exemption for conditions of use where compliance with a requirement would significantly disrupt the national economy, national security, or infrastructure. As described in Units IV.B.2.b. and V.A.2., based on reasonably available information, EPA analyzed the need for an exemption and has found that a TSCA section 6(g) exemption may be warranted under the second alternative regulatory action for the industrial and commercial use in maskant for chemical milling and for the industrial and commercial use in vapor degreasing if the workplaces engaged in those conditions of use cannot meet the requirements of the proposed regulatory action (PCE WCPP) or primary alternative regulatory action (prescriptive controls) such that those conditions of use would no longer drive the unreasonable risk. A section 6(g) exemption may mean that the unreasonable risk will not be fully addressed. As required under TSCA section 6(c)(2)(C) and detailed in Unit V.B., EPA also considered to the extent practicable whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. To that end, in addition to the Economic Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using reasonably available information (Ref. 56). For this assessment, EPA identified and analyzed alternatives to PCE in products relevant to industrial, commercial, and consumer conditions of use. Based on reasonably available information, including information submitted by industry, EPA understands viable alternatives to PCE may not be available for several conditions of use— for example, the industrial and commercial use in vapor degreasing for certain applications (Refs. 57, 58)—and considered that information to the extent practicable in the development of the regulatory options. Regarding timeframes for compliance, as described in Unit IV.A.1, 2, and 3, the proposed compliance dates incorporate EPA’s consideration of sustained awareness of risks resulting from PCE exposure as well as precedent established by the OSHA standards (62 PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 FR 1494, January 10, 1997). TSCA requires that EPA propose timeframes that are ‘‘as soon as practicable’’ under TSCA section 6(d)(1)(B) and 6(d)(1)(D). TSCA section 6(d)(1)(C) also requires that EPA specify mandatory compliance dates for the start of ban or phase-out requirements ‘‘as soon as practicable’’ but not later than five years after the promulgation date of a rule. In developing the proposed compliance timeframes, including for the prohibition and phaseout of PCE in dry cleaning as outlined in Unit IV.A.1.c., EPA considered reasonably available information. EPA has no information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products affected by the proposed restrictions to clear the channels of trade. As noted earlier, EPA is seeking public comment on whether additional time is needed for compliance with prohibitions, for products to clear the channels of trade, or for implementing a WCPP or prescriptive controls. EPA may finalize shorter or longer compliance timeframes based on public comment. Regarding potential regulatory flexibilities for compliance dates and timeframes, EPA notes that the primary alternative regulatory action would include longer compliance timeframes for prohibitions. Given the potential severity of impacts from exposure to PCE, EPA’s proposed regulatory action and second alternative regulatory action would include relatively rapid compliance timeframes. However, it is possible that longer timeframes would be needed for entities to come into compliance; therefore, the primary alternative regulatory action described in the proposed rule would include longer timeframes for implementation than the proposed regulatory action. These timeframes are detailed in Unit IV. Information on the estimated costs of the shorter and longer timeframes for the dry cleaning phaseout are in Chapter 7.7.3 of the Economic Analysis. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The action would affect entities that use PCE. It is not expected to affect State, local, or Tribal governments because the use of PCE by government entities is minimal. This action is not expected to result in expenditures by State, local, and Tribal governments, in the E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 aggregate, or by the private sector, of $100 million or more (when adjusted annually for inflation) in any 1 year. Accordingly, this action is not subject to the requirements of sections 202, 203, or 205 of UMRA. E. Executive Order 13132: Federalism EPA has concluded that this action has federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because regulations under TSCA section 6(a) may preempt State law. As set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA section 6(a) to address the unreasonable risk presented by a chemical substance has the potential to trigger preemption of laws, criminal penalties, or administrative actions by a State or political subdivision of a State that are: (1) Applicable to the same chemical substance as the rule under TSCA section 6(a); and (2) Designed to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of that same chemical. TSCA section 18(c)(3) applies that preemption only to the ‘‘hazards, exposures, risks, and uses or conditions of use’’ of such chemical included in the final TSCA section 6(a) rule. EPA provides the following preliminary federalism summary impact statement. The Agency consulted with State and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. This included background presentation on September 9, 2020, and a consultation meeting on July 22, 2021. EPA invited the following national organizations representing State and local elected officials to these meetings: American Water Works Association, Association of Clean Water Administrators, Association of Metropolitan Water Agencies, Association of State Drinking Water Administrators, Environmental Council of the States, National Association of Counties, National Conference of State Legislatures, National Governors Association, National League of Cities, National Water Resources Association, and United States Conference of Mayors. During the consultation, stakeholders in attendance asked about the differences between PCE and TCE, recommended additional reporting requirements as a risk management tool to address the unreasonable risk, suggested EPA look into safer alternatives, and described concerns related to current impacts on drinking water utilities from PCE (Ref. 25). A summary of the meeting with these organizations, including the views that VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 they expressed, is available in the docket (Ref. 25). EPA provided an opportunity for these organizations to provide follow-up comments in writing but did not receive any such comments. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. This rulemaking would not have substantial direct effects on Tribal governments because PCE is not manufactured, processed, or distributed in commerce by Tribes. PCE is not regulated by Tribes, and this rulemaking would not impose substantial direct compliance costs on Tribal governments. Thus, Executive Order 13175 does not apply to this action. Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, EPA consulted with Tribal officials during the development of this action. The Agency held a Tribal consultation from May 17, 2021, to August 20, 2021, with meetings on June 15, 2021, and July 8, 2021. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for PCE, types of information to inform risk management, principles for transparency during risk management, and types of information EPA is seeking from Tribes (Ref. 26). EPA briefed Tribal officials on the Agency’s risk management considerations and encouraged Tribal officials to provide additional comments after the teleconferences. Tribal officials raised no related issues or concerns to EPA during or in follow-up to those meetings (Ref. 26). G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 39715 children as reflected by the conclusions of the PCE risk evaluation. This action’s health and risk assessments are contained in Unit III.A.3, III.B.2, VI.A. and B., and the 2020 Risk Evaluation for PCE and the Economic Analysis for this proposed rulemaking (Refs. 1 and 3). H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use This action is not a ‘‘significant energy action’’ under Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. I. National Technology Transfer and Advancement Act (NTTAA) Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has determined that this rulemaking involves environmental monitoring or measurement, specifically for occupational inhalation exposures to PCE. Consistent with the Agency’s Performance Based Measurement System (PBMS), the Agency proposes not to require the use of specific, prescribed analytic methods. Rather, the Agency plans to allow the use of any method that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified. For this rulemaking, the key consideration for the PBMS approach is the ability to accurately detect and measure airborne concentrations of PCE at the ECEL and the ECEL action level. Some examples of methods which meet the criteria are included in appendix B of the ECEL memo (Ref. 10). EPA recognizes that there may be voluntary consensus standards that meet the proposed criteria (Ref. 81). EPA requests comments on whether it should incorporate such voluntary consensus standards in the rule and seeks information in support of such comments regarding the availability and applicability of voluntary consensus standards that may achieve the sampling and analytical requirements of the rule in lieu of the PBMS approach. E:\FR\FM\16JNP3.SGM 16JNP3 39716 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS3 J. Executive Orders 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629, February 16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make EJ part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or indigenous peoples) and low-income populations. EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples. As described more fully in the Economic Analysis, EPA conducted an analysis to characterize the baseline conditions faced by communities and workers affected by the regulation to identify the potential for disproportionate impacts on minority and low-income populations. The baseline characterization suggests that workers in affected industries and regions, as well as residents of nearby communities, are more likely to be people of color than the general population in affected states, although this varied by use assessed. Additionally, based on reasonably available information, the Agency understands that most dry cleaning workers are members of minority populations. EPA believes that this action is likely to reduce existing disproportionate and adverse effects on people of color, lowincome populations and/or Indigenous peoples. While the regulatory options are anticipated to address the unreasonable risk from exposure to PCE to the extent necessary so that it is no longer unreasonable, EPA is not able to quantify the distribution of the change in risk across affected workers, communities, or demographic groups. EPA is also unable to quantify the changes in risks to workers, communities, and demographic groups from non-PCE-using technologies or practices that firms may adopt in response to the regulation to determine whether any such changes could pose EJ concerns. Data limitations that prevent EPA from conducting a more comprehensive analysis are summarized in the Economic Analysis (Ref. 3). VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 EPA additionally identified and addressed EJ concerns by conducting outreach to advocates of communities that might be subject to disproportionate exposure to PCE, such as minority populations, low-income populations and indigenous peoples. On June 16, 2021, and July 6, 2021, EPA held public meetings as part of this consultation (Ref. 32). See also Unit III.A.1. These meetings were held pursuant to and in compliance with Executive Order 12898 and Executive Order 14008, entitled ‘‘Tackling the Climate Crisis at Home and Abroad’’ (86 FR 7619, February 1, 2021). Following the EJ meetings, EPA received five written comments, in addition to oral comments provided during the consultations. In general, commenters supported strong outreach to affected communities, encouraged EPA to follow the hierarchy of controls, favored prohibitions, and noted the uncertainty, and in some cases inadequacy, of PPE. Commenters also urged the EPA to extend the rulemaking into ongoing releases from hazardous waste and disposal sites, in particular vapor intrusion of PCE from contaminated groundwater, soil, and indoor air. Additionally, commenters expressed concern that the adverse health impacts of PCE dry cleaning fall disproportionately to owners and employees of minority owned small businesses, noted the viability of professional wet cleaning as an alternative to PCE dry cleaning, and urged EPA to consider economic impacts and a financial program to offset transition costs to local communities. The information supporting the review under Executive Order 12898 is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic Analysis (Ref. 3). EPA’s presentations and fact sheets for the EJ consultations related to this rulemaking, are available at https:// www.epa.gov/assessing-and-managingchemicals-under-tsca/materials-juneand-july-2021-environmental-justice. These materials and a summary of the consultation are also available in the public docket for this rulemaking (Ref. 32). List of Subjects in 40 CFR Part 751 Environmental protection, Chemicals, Export notification, Hazardous substances, Import certification, Reporting and recordkeeping. Michael S. Regan, Administrator. Therefore, for the reasons stated in the preamble, EPA proposes to amend 40 CFR part 751 as follows: PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 PART 751—REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT 1. The authority citation for part 751 continues to read as follows: ■ Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4) 2. Amend § 751.5 by adding in alphabetical order definitions for ‘‘Authorized person’’, ‘‘Direct dermal contact’’, ‘‘ECEL’’, ‘‘Exposure group’’, ‘‘Owner or operator’’, ‘‘Potentially exposed person’’, ‘‘Regulated area’’, and ‘‘Retailer’’ to read as follows: ■ § 751.5 Definitions. * * * * * Authorized person means any person specifically authorized by the owner or operator to enter, and whose duties require the person to enter, a regulated area. * * * * * Direct dermal contact means direct handling of a chemical substance or mixture or skin contact with surfaces that may be contaminated with a chemical substance or mixture. ECEL is an Existing Chemical Exposure Limit and means an airborne concentration generally calculated as an eight (8)-hour time-weighted average (TWA). * * * * * Exposure group means a group consisting of every person performing the same or substantially similar operations in each work shift, in each job classification, in each work area where exposure to chemical substances or mixtures is reasonably likely to occur. Owner or operator means any person who owns, leases, operates, controls, or supervises a workplace covered by this part. * * * * * Potentially exposed person means any person who may be occupationally exposed to a chemical substance or mixture in a workplace as a result of a condition of use of that chemical substance or mixture. Regulated area means an area established by the regulated entity to demarcate areas where airborne concentrations of a specific chemical substance exceed, or there is a reasonable possibility they may exceed, the ECEL or the EPA Short-Term Exposure Limit (STEL). Retailer means a person who distributes in commerce or makes available a chemical substance or mixture to consumer end users, including e-commerce internet sales or E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules distribution. Any distributor with at least one consumer end user customer is considered a retailer. A person who distributes in commerce or makes available a chemical substance or mixture solely to commercial or industrial end users or solely to commercial or industrial businesses is not considered a retailer. ■ 3. Add subpart G to read as follows: Subpart G—Perchloroethylene Sec. 751.601 General. 751.603 Definitions. 751.605 Prohibitions of manufacturing, processing, distribution in commerce, and use. 751.607 Workplace Chemical Protection Program. 751.609 Workplace requirements for laboratory use. 751.611 Downstream notification. 751.613 Recordkeeping requirements. 751.615 Exemptions. Subpart G—Perchloroethylene § 751.601 General. This subpart establishes prohibitions and restrictions on the manufacture (including import), processing, distribution in commerce, use, and disposal of perchloroethylene (CASRN 127–18–4), also known as tetrachloroethylene, to prevent unreasonable risk of injury to health in accordance with TSCA section 6(a). ddrumheller on DSK120RN23PROD with PROPOSALS3 § 751.603 Definitions. The definitions in subpart A of this part apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply: Distribute in commerce has the same meaning as in section 3 of the Act, except that the term does not include retailers for purposes of §§ 751.611 and 751.613. ECEL action level means a concentration of airborne perchloroethylene of 0.07 part per million (ppm) calculated as an eight (8)hour time-weighted average (TWA). 3rd generation machine means a dryto-dry machine with a refrigerated condenser, as those terms are defined in 40 CFR part 63, subpart M. 4th or 5th generation machine means a dry-to-dry machine with a carbon adsorber and refrigerated condenser, as those terms are defined in 40 CFR part 63, subpart M. § 751.605 Prohibitions of manufacturing, processing, distribution in commerce, and use. (a) Applicability. The provisions of this section apply to the following uses as indicated in each paragraph of this section: VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 (1) All consumer use, excluding use of clothing and articles that have been commercially dry cleaned with perchloroethylene. (2) Processing into formulation, mixture or reaction product in other chemical products and preparations. (3) Dry cleaning use, including: (i) Industrial and commercial use in dry cleaning and related spot cleaning in 3rd generation machines; and (ii) Industrial and commercial use in dry cleaning and related spot cleaning in 4th and 5th generation machines. (4) All other industrial and commercial use, except for the following: (i) Those industrial and commercial uses presented in § 751.607(a); (ii) Laboratory use as described in § 751.609(a); and (iii) Any industrial and commercial use of clothing and articles that have been commercially dry cleaned with perchloroethylene. (5) Distribution in commerce. (b) Prohibitions. (1) After [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from manufacturing (including importing) perchloroethylene for the uses listed in paragraphs (a)(1), (2) and (4) of this section. (2) After [DATE 15 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from processing perchloroethylene, including any perchloroethylenecontaining products, for the uses listed in paragraphs (a)(1), (2) and (4) of this section. (3) After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from distributing in commerce (including making available) perchloroethylene, including any perchloroethylene-containing products, to retailers for any use, other than commercial dry cleaning or consumer use of clothing and articles that have been commercially dry cleaned with perchloroethylene. (4) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all retailers are prohibited from distributing in commerce (including making available) perchloroethylene, including any perchloroethylene-containing products. Distribution in commerce by retailers of clothing and articles that have been commercially dry cleaned with perchloroethylene is not subject to the PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 39717 prohibitions described in this paragraph. (5) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from distributing in commerce (including making available) perchloroethylene, including any perchloroethylene-containing products, for the uses described in paragraphs (a)(1) and (4) of this section. (6) After [DATE 24 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from industrial or commercial use of perchloroethylene, including any perchloroethylene-containing products, for the uses listed in paragraph (a)(4) of this section. (7) All persons are prohibited from industrial or commercial use of perchloroethylene in dry cleaning machines acquired after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]. (8) After [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from industrial or commercial use of perchloroethylene for the use listed in paragraph (a)(3)(i) of this section. (9) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from the manufacturing (including importing), processing, distribution in commerce, or industrial or commercial use of perchloroethylene for dry cleaning and spot cleaning, including for the use listed in paragraph (a)(3)(ii) of this section. (c) De minimis level. Products containing perchloroethylene at levels less than 0.1 percent by weight are not subject to the prohibitions described in paragraph (b) of this section. § 751.607 program. Workplace chemical protection (a) Applicability. The provisions of this section apply to workplaces engaged in the following conditions of use of perchloroethylene, unless otherwise indicated in this section, except to the extent the conditions of use are prohibited by § 751.605: (1) Manufacturing (domestic manufacture); (2) Manufacturing (import); (3) Processing as a reactant/ intermediate; (4) Processing into formulation, mixture or reaction product in paint and coating products; E:\FR\FM\16JNP3.SGM 16JNP3 39718 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules (5) Processing into formulation, mixture or reaction product in cleaning and degreasing products; (6) Processing into formulation, mixture or reaction product in adhesive and sealant products (7) Repackaging; (8) Industrial and commercial use as solvent for open-top batch vapor degreasing; (9) Industrial and commercial use as solvent for closed-loop batch vapor degreasing; (10) Industrial and commercial use as solvent for in-line conveyorized vapor degreasing; (11) Industrial and commercial use as solvent for in-line web cleaner vapor degreasing; (12) Industrial and commercial use in maskant for chemical milling; (13) Industrial and commercial use in solvent-based adhesives and sealants; (14) Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing; (15) Recycling; and (16) Disposal. (b) Existing chemical exposure limit (ECEL)—(1) Applicability. The provisions of this paragraph (b) apply to any workplace engaged in a condition of use that is listed in paragraphs (a)(1) through (14) of this section and not prohibited by § 751.605. (2) Eight-hour time-weighted average (TWA) ECEL. Beginning [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or beginning 4 months after introduction of perchloroethylene into the workplace if perchloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or operator must ensure that no person is exposed to an airborne concentration of perchloroethylene in excess of 0.14 parts of perchloroethylene per million parts of air (0.14 ppm) as an eight (8)-hour TWA, in accordance with the requirements of paragraph (d)(1)(i) of this section and, if necessary, paragraph (f) of this section. (3) Exposure monitoring—(i) General. (A) Owners or operators must determine each potentially exposed person’s exposure by either: (1) Taking a personal breathing zone air sample of each potentially exposed person’s exposure; or (2) Taking personal breathing zone air samples that are representative of the 8hour TWA of each person whose exposure must be monitored. (B) Representative 8-hour TWA exposures must be determined on the basis of one or more full-shift exposure of at least one person that represents, and does not underestimate, the potential exposure of every person in each exposure group and that represents the highest perchlorethylene exposures likely to occur under reasonably foreseeable conditions of use. (C) Exposure samples must be analyzed using an appropriate analytical method by a laboratory that complies with the Good Laboratory Practice Standards in 40 CFR part 792. (D) Owners or operators must ensure that methods used to perform exposure monitoring produce results that are accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of perchloroethylene. (E) Owners and operators must remonitor within 15 working days after receipt of any exposure monitoring when results indicate 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 remonitoring is not necessary. (ii) Initial monitoring. (A) Each owner or operator who has a workplace or work operation covered by this section, except as provided for in paragraph (b)(3)(ii)(B) of this section, must perform initial monitoring of potentially exposed persons regularly working in areas where perchloroethylene is present. (B) The initial monitoring required in paragraph (b)(3)(ii)(A) of this section must be completed by [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or within 30 days of introduction of perchloroethylene into the workplace, whichever is later. Where the owner or operator has monitoring within five years prior to [the effective date of the final rule] and the monitoring satisfies all other requirements of this section, the owner or operator may rely on such earlier monitoring results to satisfy the requirements of paragraph (b)(3)(ii)(A) of this section. (iii) Periodic monitoring. The owner or operator must establish an exposure monitoring program for periodic monitoring of exposure to perchloroethylene in accordance with table 1 to this paragraph (b)(3)(iii). ddrumheller on DSK120RN23PROD with PROPOSALS3 TABLE 1 TO § 751.607(b)(3)(iii)—PERIODIC MONITORING REQUIREMENTS Air concentration condition Periodic monitoring requirement If all initial exposure monitoring is below ECEL action level ................... (<0.07 ppm 8-hour TWA) ......................................................................... If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (≤0.14 ppm 8-hour TWA). If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level but at or below the ECEL (≥0.07 ppm 8-hour TWA, ≤0.14 ppm 8-hour TWA). If the two most recent (non-initial) exposure monitoring measurements, taken at least seven days apart within a 6 month period, indicate exposure is below the ECEL action level (<0.07 ppm 8-hour TWA). If the owner or operator engages in a condition of use for which WCPP ECEL is required but does not manufacture, process, use, or dispose of perchlorethylene in that condition of use over the entirety of time since the last required monitoring event. Periodic exposure monitoring is required at least once every five years. (iv) Additional monitoring. (A) The owner or operator must conduct additional initial exposure monitoring whenever there has been a change in the production, process, control equipment, VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 Periodic exposure monitoring is required within 3 months of the most recent exposure monitoring. Periodic exposure monitoring is required within 6 months of the most recent exposure monitoring. Periodic exposure monitoring is required within 5 years of the most recent exposure monitoring. The owner or operator may forgo the next periodic monitoring event. However, documentation of cessation of use of perchlorethylene is required; and periodic monitoring would be required when the owner or operator resumes the condition of use. personnel or work practices that may reasonably be expected to result in new or additional exposures above the ECEL action level or when the owner or operator has any reason to believe that PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 new or additional exposures above the ECEL action level have occurred. (B) Whenever start-ups, shutdown, spills, leaks, ruptures or other breakdowns occur that may lead to E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules exposure to potentially exposed persons, the owner or operator must conduct additional initial exposure monitoring (using personal breathing zone sampling) after the cleanup of the spill or repair of the leak, rupture or other breakdown. (v) Notification of monitoring results. (A) The owner or operator must inform persons whose exposures are represented by the monitoring of the monitoring results within 15 working days. (B) This notification must include the following: (1) Exposure monitoring results; (2) Identification and explanation of the ECEL and ECEL action level in plain language; (3) Explanation of any corresponding required respiratory protection as described in paragraph (f) of this section; (4) Descriptions of actions taken by the regulated entity to reduce exposure to or below the ECEL; (5) Quantity of perchloroethylene in use; (6) Location of perchloroethylene use; (7) Manner of perchloroethylene use; (8) Identified releases of perchloroethylene; and (9) Whether the airborne concentration of perchloroethylene exceeds the ECEL limit. (C) Notice must be provided in plain language writing, in a language that the person understands, to each potentially exposed person or posted in an appropriate and accessible location outside the regulated area with an English-language version and a nonEnglish language version representing the language of the largest group of workers who do not read English. (4) Regulated areas. (i) Beginning [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or beginning 4 months after introduction of perchloroethylene into the workplace if perchloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or operator must establish and maintain a regulated area wherever any person’s exposure to airborne concentrations of perchloroethylene exceeds or can reasonably be expected to exceed the ECEL. (ii) The owner or operator must limit access to regulated areas to authorized persons. (iii) The owner or operator must demarcate regulated areas from the rest of the workplace in a manner that adequately establishes and alerts persons to the boundaries of the area VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 and minimizes the number of authorized persons exposed to perchloroethylene within the regulated area. (iv) The owner or operator must supply a respirator that complies with the requirements of paragraph (f) of this section and must ensure that all persons within the regulated area are using the provided respirators whenever perchloroethylene exposures may exceed the ECEL. (v) An owner or operator who has implemented all feasible engineering, work practice and administrative controls as required in paragraph (d)(1)(i) of this section, and who has established a regulated area as required by paragraph (b)(4)(i) of this section where perchloroethylene exposure can be reliably predicted to exceed the ECEL only on certain days (for example, because of work or process schedule) must have persons use respirators in that regulated area on those days. (vi) The owner or operator must ensure that, within a regulated area, persons do not engage in non-work activities which may increase perchloroethylene exposure. (vii) The owner or operator must ensure that while persons are wearing respirators in the regulated area, they do not engage in activities which interfere with respirator seal or performance. (c) Direct dermal contact controls. (1) The provisions of this paragraph (c) apply to any workplace engaged in the conditions of use that are listed in paragraphs (a)(1) through (16) of this section and are not prohibited by § 751.605. (2) Owners or operators must ensure that all persons are separated, distanced, physically removed, or isolated from direct dermal contact with perchloroethylene in accordance with the requirements of paragraph (d)(1)(ii) of this section and, if necessary, paragraph (f) of this section. (d) Exposure control procedures and plan—(1) Methods of compliance—(i) ECEL. (A) The owner or operator must institute one or a combination of elimination, substitution, engineering controls or administrative controls to reduce exposure to or below the ECEL except to the extent that the owner or operator can demonstrate that such controls are not feasible. (B) Wherever the feasible exposure controls, including one or a combination of elimination, substitution, engineering controls or administrative controls, which can be instituted are not sufficient to reduce exposure to or below the ECEL, the owner or operator must use them to reduce exposure to the lowest levels PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 39719 achievable by these controls and must supplement them by the use of respiratory protection that complies with the requirements of paragraph (f) of this section. Where an owner or operator cannot demonstrate exposure below the ECEL, including through the use of engineering controls or work practices, and has not demonstrated that it has supplemented feasible exposure controls with respiratory protection that complies with the requirements of paragraph (f) of this section, this will constitute a failure to comply with the ECEL. (C) The owner or operator must maintain the effectiveness of engineering controls and administrative controls instituted under paragraph (d)(1)(i)(A) of this section. (D) The owner or operator must not implement a schedule of personnel rotation as a means of compliance with the ECEL. (E) The owner or operator must document their exposure control strategy and implementation in an exposure control plan in accordance with paragraph (d)(2) of this section. (ii) Direct dermal contact control requirements. (A) The owner or operator must institute one or a combination of elimination, substitution, engineering controls, or administrative controls to prevent all persons from direct dermal contact with perchloroethylene except to the extent that the owner or operator can demonstrate that such controls are not feasible. (B) Wherever the feasible exposure controls, including one or a combination of elimination, substitution, engineering controls or administrative controls, which can be instituted are not sufficient to prevent direct dermal contact, the owner or operator must use them to reduce direct dermal contact to the extent achievable by these controls and must supplement them by the use of dermal personal protective equipment that complies with the requirements of paragraph (f) of this section. Where an owner or operator cannot demonstrate direct dermal contact is prevented, including through the use of engineering controls or work practices, and has not demonstrated that it has supplemented feasible exposure controls with dermal personal protective equipment that complies with the requirements of paragraph (f) of this section, this will constitute a failure to comply with the direct dermal contact control requirements. (C) The owner or operator must maintain the effectiveness of engineering controls and administrative E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 39720 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules controls instituted under paragraph (d)(1)(ii)(A) of this section. (D) The owner or operator must document their exposure control strategy and implementation in an exposure control plan in accordance with paragraph (d)(2) of this section. (2) Exposure control plan requirements. Beginning [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners and operators must include and document in an exposure control plan the following: (i) Identification and rationale of exposure controls used or not used in the following sequence: elimination of perchloroethylene, substitution of perchloroethylene, engineering controls and administrative controls to reduce exposures in the workplace to either at or below the ECEL or to the lowest level achievable and to prevent or reduce direct dermal contact with perchloroethylene in the workplace; (ii) The exposure controls selected based on feasibility, effectiveness, and other relevant considerations; (iii) If exposure controls were not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented; (iv) Actions taken to implement exposure controls selected, including proper installation, maintenance, training or other steps taken; (v) Description of any regulated area and how it is demarcated, and identification of authorized persons; and description of when the owner or operator expects exposures may be likely to exceed the ECEL; (vi) Regular inspections, evaluations, and updating of the exposure controls to ensure effectiveness and confirmation that all persons are implementing them as required; (vii) Occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes air concentrations to be above the ECEL or any direct dermal contact with perchloroethylene and subsequent corrective actions taken during start-up, shutdown, or malfunctions to mitigate exposures to perchloroethylene; and (viii) Availability of the exposure control plan and associated records for potentially exposed persons. (e) Workplace information and training. (1) The owner or operator must provide information and training for each person prior to or at the time of initial assignment to a job involving potential exposure to perchloroethylene. (2) The owner or operator must ensure that information and training is VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 presented in a manner that is understandable to each person required to be trained. (3) The following information and training must be provided to all persons assigned to a job involving potential exposure to perchloroethylene: (i) The requirements of this section, as well as how to access or obtain a copy of these requirements in the workplace; (ii) The quantity, location, manner of use, release, and storage of perchloroethylene and the specific operations in the workplace that could result in exposure to perchloroethylene, particularly noting where exposures may be above the ECEL or where there is potential for direct dermal contact with perchloroethylene; (iii) Methods and observations that may be used to detect the presence or release of perchloroethylene in the workplace (such as monitoring conducted by the owner or operator, continuous monitoring devices, visual appearance or odor of perchloroethylene when being released, etc.); (iv) The health hazards of perchloroethylene in the workplace; and (v) The principles of safe use and handling of perchloroethylene and measures potentially exposed persons can take to protect themselves from perchloroethylene, including specific procedures the owner or operator has implemented to protect potentially exposed persons from exposure to perchloroethylene, such as appropriate work practices, emergency procedures, and personal protective equipment to be used. (4) The owner or operator must retrain each potentially exposed person annually to ensure that each such person maintains the requisite understanding of the principles of safe use and handling of perchloroethylene in the workplace. (5) Whenever there are workplace changes, such as modifications of tasks or procedures or the institution of new tasks or procedures, which increase exposure, and where those exposures exceed or can reasonably be expected to exceed the ECEL action level or increase potential for direct dermal contact, the owner or operator must update the training as necessary to ensure that each potentially exposed person has the requisite proficiency. (f) Personal protective equipment (PPE). (1) The provisions of this paragraph (f) apply to any owner or operator that is required to provide respiratory protection or dermal protection pursuant to paragraph (d)(1)(i)(B) or (d)(1)(ii)(B) of this section or § 751.609(b)(2). PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 (2) PPE, including respiratory and dermal protection, that is of safe design and construction for the work to be performed must be provided, used, and maintained in a sanitary, reliable, and undamaged condition. Owners and operators must select PPE that properly fits each affected person and communicate PPE selections to each affected person. (3) Owners and operators must provide PPE training in accordance with 29 CFR 1910.132(f) to all persons required to use PPE prior to or at the time of initial assignment to a job involving potential exposure to perchloroethylene. For the purposes of this paragraph (f)(3), provisions in 29 CFR 1910.132(f) applying to an ‘‘employee’’ also apply equally to potentially exposed persons, and provisions applying to an ‘‘employer’’ also apply equally to owners or operators. (4) Owners and operators must retrain each potentially exposed person required to use PPE annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete. (5) Respiratory protection. (i) Beginning [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or within 3 months after receipt of any exposure monitoring that indicates exposures exceeding the ECEL, the owner or operator must supply a respirator, selected in accordance with this paragraph, to each person who enters a regulated area and must ensure that all persons within the regulated area are using the provided respirators whenever perchloroethylene exposures may exceed the ECEL. (ii) Owners or operators must provide respiratory protection in accordance with the provisions outlined in 29 CFR 1910.134(a) through (l) (except paragraph (d)(1)(iii)) and as specified in this paragraph for persons exposed or who may be exposed to perchloroethylene in concentrations above the ECEL. For the purpose of this paragraph (f), the maximum use concentration (MUC) as used in 29 CFR 1910.134 must be calculated by multiplying the assigned protection factor (APF) specified for a respirator by the ECEL. For the purposes of this paragraph (f)(5)(ii), provisions in 29 CFR 1910.134(a) through (l) (except paragraph (d)(1)(iii)) applying to an ‘‘employee’’ also apply equally to potentially exposed persons, and E:\FR\FM\16JNP3.SGM 16JNP3 ddrumheller on DSK120RN23PROD with PROPOSALS3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules provisions applying to an ‘‘employer’’ also apply equally to owners or operators. (iii) Owners or operators must select and provide to persons appropriate respirators as indicated by the most recent monitoring results as follows: (A) If the measured exposure concentration is at or below 0.14 ppm: no respiratory protection is required. (B) If the measured exposure concentration is above 0.14 ppm and less than or equal to 0.7 ppm (5 times ECEL): Any National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying quarter mask respirator (APF 5). (C) If the measured exposure concentration is above 0.7 ppm and less than or equal to 1.4 ppm (10 times ECEL): Any NIOSH-certified airpurifying half mask or full facepiece respirator equipped with NIOSHapproved organic vapor cartridges or canisters (APF 10). (D) If the measured exposure concentration is above 1.4 ppm and less than or equal to 3.5 ppm (25 times ECEL): Any NIOSH-certified airpurifying full facepiece respirator equipped with NIOSH-approved organic vapor cartridges or canisters; any NIOSH-certified powered air-purifying respirator equipped with NIOSHapproved organic vapor cartridges; or any NIOSH-certified continuous flow supplied air respirator equipped with a hood or helmet (APF 25). (E) If the measured exposure concentration is above 3.5 ppm and less than or equal to 7.0 ppm (50 times ECEL): Any NIOSH-certified airpurifying full facepiece respirator equipped with NIOSH-approved organic vapor cartridges or canisters; or any NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece and a NIOSH-approved organic vapor cartridge (APF 50). (F) If the measured exposure concentration is above 7.0 ppm and less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH-certified supplied air respirator equipped with a half mask or full facepiece and operated in a pressure demand or other positive pressure mode (APF 1,000). (G) If the measured exposure concentration is greater than 140 ppm (1,000 times ECEL) or the concentration is unknown: Any NIOSH-certified selfcontained breathing apparatus equipped with a full facepiece and operated in a pressure demand or other positive pressure mode; or any NIOSH-certified supplied air respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode in combination with an auxiliary self- VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 contained breathing apparatus operated in a pressure demand or other positive pressure mode (APF 10,000). (iv) The respiratory protection requirements in this paragraph represent the minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the required respirator may be used. (v) When a person whose job requires the use of a respirator cannot use a negative-pressure respirator, the owner or operator must provide that person with a respirator that has less breathing resistance than the negative-pressure respirator, such as a powered airpurifying respirator or supplied-air respirator, when the person is able to use it and if it provides the person with adequate protection. (6) Dermal protection. (i) The owner or operator must supply and require the donning of dermal PPE that separates and provides a barrier to prevent direct dermal contact with perchloroethylene in the specific work area where it is selected for use, selected in accordance with this paragraph (f)(6)(i) and provided in accordance with 29 CFR 1910.132(h), to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with perchloroethylene. For the purposes of this paragraph (f)(6)(i), provisions in 29 CFR 1910.132(h) applying to an ‘‘employer’’ also applies equally to owners or operators. (ii) Owners or operators must select and provide dermal PPE in accordance with 29 CFR 1910.133(b) and additionally as specified in this paragraph to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with perchloroethylene. For the purposes of this paragraph (f)(6)(ii), provisions in 29 CFR 1910.133(b) applying to an ‘‘employer’’ also apply equally to owners or operators. (iii) Owners or operators must select and provide to persons appropriate dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use. Dermal PPE must include, but is not limited to, the following items: (A) Impervious gloves selected based on specifications from the manufacturer or supplier. (B) Impervious clothing covering the exposed areas of the body (e.g., long pants, long sleeved shirt). (iv) Demonstration of imperviousness. Owners or operators must demonstrate PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 39721 that each item of gloves and other clothing selected provides an impervious barrier to prevent direct dermal contact with perchloroethylene during normal and expected duration and conditions of exposure within the work area by evaluating the specifications from the manufacturer or supplier of the clothing, or of the material used in construction of the clothing, to establish that the clothing will be impervious to perchloroethylene alone and in likely combination with other chemical substances in the work area. § 751.609 Workplace requirements for laboratory use. (a) Applicability. The provisions of this section apply to workplaces engaged in the industrial and commercial use of perchloroethylene as a laboratory chemical. (b) Laboratory use requirements. (1) After [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners or operators must ensure fume hoods 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 perchloroethylene is used in a laboratory setting. (2) After [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners or operators must ensure that all persons reasonably likely to be exposed from direct dermal contact to perchloroethylene in a laboratory setting are provided with dermal personal protective equipment as outlined in § 751.607(f)(2) and (6) and training on proper use of PPE as outlined in § 751.607(f)(3) and (4). § 751.611 Downstream notification. (a) Beginning on [DATE 2 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], each person who manufactures (including imports) perchloroethylene for any use must, prior to or concurrent with the shipment, notify companies to whom perchloroethylene is shipped, in writing, of the restrictions described in this subpart in accordance with paragraph (c) of this section. (b) Beginning on [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], each person who processes or distributes in commerce perchloroethylene or any perchloroethylene-containing products for any use must, prior to or concurrent E:\FR\FM\16JNP3.SGM 16JNP3 39722 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules with the shipment, notify companies to whom perchloroethylene is shipped, in writing, of the restrictions described in this subpart in accordance with paragraph (c) of this section. (c) The notification required under paragraphs (a) and (b) of this section must occur by inserting the following text in section 1(c) and 15 of the Safety Data Sheet (SDS) provided with the perchloroethylene or with any perchloroethylene-containing product: After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] this chemical/ product cannot be distributed in commerce to retailers for any use. After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], this chemical/product is and can only be distributed in commerce or processed for the following purposes: Processing as a reactant/intermediate; Processing into formulation, mixture or reaction product in cleaning and vapor degreasing products; Processing into formulation, mixture or reaction product in paint and coating products; Processing into formulation, mixture or reaction product in adhesive and sealant products; Processing by repackaging; Recycling; Industrial and commercial use as solvent in vapor degreasing; Industrial and commercial use in maskant for chemical milling; Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing; Industrial and commercial use in laboratory chemicals; Industrial and commercial use in solvent-based adhesives and sealants; Industrial and commercial use in dry cleaning in 3rd generation machines until [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; Industrial and commercial use in all dry cleaning and related spot cleaning until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; and Disposal. ddrumheller on DSK120RN23PROD with PROPOSALS3 § 751.613 Recordkeeping requirements. (a) General records. After [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons who manufacture, process, distribute in commerce, or engage in industrial or commercial use of perchloroethylene or perchloroethylene-containing products must maintain ordinary business records, such as downstream notifications, invoices and bills-oflading related to compliance with the prohibitions, restrictions, and other provisions of this subpart. (b) Workplace Chemical Protection Program compliance. (1) ECEL exposure monitoring. For each monitoring event, owners or operators subject to the ECEL described in § 751.607(b) must document the following: VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 (i) Dates, duration, and results of each sample taken; (ii) All measurements that may be necessary to determine the conditions that may affect the monitoring results; (iii) Name, workplace address, work shift, job classification, and work area of the person monitored; documentation of all potentially exposed persons whose exposures the monitoring is intended to represent if using a representative sample; and type of respiratory protective device worn by the monitored person, if any (iv) Use of appropriate sampling and analytical methods, such as analytical methods already approved by EPA, Occupational Safety and Health Administration (OSHA) or NIOSH, or compliance with an analytical method verification procedure; (v) Compliance with the Good Laboratory Practice Standards in accordance with 40 CFR part 792; and (vi) Information regarding air monitoring equipment, including: type, maintenance, calibrations, performance tests, limits of detection, and any malfunctions. (2) ECEL compliance. Owners or operators subject to the ECEL described in § 751.607(b) must retain records of: (i) Exposure control plan as described in § 751.607(d)(2); (ii) Facility exposure monitoring records; (iii) Notifications of exposure monitoring results; (iv) The name, workplace address, work shift, job classification, work area and respiratory protection used by each potentially exposed person and PPE program implementation as described in § 751.607(f), including fit-testing and training; and (v) Information and training provided by the regulated entity to each person prior to or at the time of initial assignment to a job involving potential exposure to perchloroethylene and any re-training as required in § 751.607(e). (3) DDCC compliance. Owners or operators subject to DDCC requirements described in § 751.607(c) must retain records of: (i) Exposure control plan as described in § 751.607(d); (ii) Dermal protection used by each potentially exposed person and PPE program implementation as described in § 751.607(f), including: (A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle perchloroethylene or handle equipment or materials on which perchloroethylene may present and the type of PPE selected to be worn by each of these persons; PO 00000 Frm 00072 Fmt 4701 Sfmt 4702 (B) The basis for specific PPE selection (e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area); (C) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/ disposal of PPE; (D) Occurrence and duration of any direct dermal contact with perchloroethylene that occurs during any activity or malfunction at the workplace that causes direct dermal exposures to occur and/or glove breakthrough, and corrective actions to be taken during and immediately following that activity or malfunction to prevent direct dermal contact to perchloroethylene; and (E) Training in accordance with § 751.607(f)(3). (iii) Information and training provided by the regulated entity to each person prior to or at the time of initial assignment to a job involving potential direct dermal contact with perchloroethylene and any re-training as required in § 751.607(e). (4) Workplace participation. Owners or operators must document the notice to and ability of any potentially exposed person that may reasonably be affected by perchloroethylene inhalation exposure or direct dermal contact to readily access the exposure control plans, facility exposure monitoring records, PPE program implementation, or any other information relevant to perchloroethylene exposure in the workplace. (c) Workplace requirements for laboratory use compliance. Owners and operators subject to the laboratory chemical requirements described in § 751.609 must retain records of: (1) Dermal protection used by each potentially exposed person and PPE program implementation, as described in § 751.613(b)(3)(ii); and (2) Documentation identifying: implementation of a properly functioning fume hood using manufacturer’s instructions for installation, use, and maintenance of the fume hood, including inspections, tests, development of maintenance procedures, the establishment of criteria for acceptable test results, and documentation of test and inspection results. (d) Records related to § 751.615 exemptions. To maintain eligibility for an exemption described in § 751.615, E:\FR\FM\16JNP3.SGM 16JNP3 Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Proposed Rules the records maintained by the owners or operators must demonstrate compliance with the specific conditions of the exemption. (e) Retention. Owners or operators must retain the records required under this section for a period of 5 years from the date that such records were generated. § 751.615 Exemptions. ddrumheller on DSK120RN23PROD with PROPOSALS3 (a) In general. (1) As provided in paragraph (b) of this section, a timelimited exemption from the requirements of § 751.605 is established in this section in accordance with 15 U.S.C. 2605(g)(1)(A). (2) In order to be eligible for the exemptions established in this section, regulated parties must comply with all conditions established for such exemptions in accordance with 15 U.S.C. 2605(g)(4). (b) Time-limited exemption. Use of perchloroethylene or perchloroethylene containing products identified in paragraph (b)(1) of this section in an emergency by the National Aeronautics and Space Administration and its contractors operating within the scope of their contracted work until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]. (1) Applicability. The emergency use exemption described in this paragraph (b) shall apply to the following specific conditions of use as described in paragraph (b)(1)(i) of this section. VerDate Sep<11>2014 19:25 Jun 15, 2023 Jkt 259001 (i) Conditions of use subject to this exemption. (A) Industrial and commercial use as solvent for cold cleaning. (B) Industrial and commercial use in wipe cleaning. (ii) Emergency use—(A) In general. An emergency is a serious and sudden situation requiring immediate action, within 15 days or less, necessary to protect: (1) Safety of National Aeronautics and Space Administration’s or their contractors’ personnel; (2) National Aeronautics and Space Administration’s missions; (3) Human health, safety, or property, including that of adjacent communities; or (4) The environment. (B) Duration. Each emergency is a separate situation; if use of perchloroethylene exceeds 15 days, then justification must be documented. (C) Eligibility. To be eligible for the exemption, the National Aeronautics and Space Administration and its contractors must: (1) Select perchloroethylene because there are no technically and economically feasible safer alternatives available during the emergency. (2) Perform the emergency use of perchloroethylene at locations controlled by National Aeronautics and Space Administration or its contractors. (2) Requirements. To be eligible for the emergency use exemption described in this paragraph (b), the National PO 00000 Frm 00073 Fmt 4701 Sfmt 9990 39723 Aeronautics and Space Administration and its contractors must comply with the following conditions: (i) Notification. Within 15 working days of the emergency use by National Aeronautics and Space Administration and its contractors, National Aeronautics and Space Administration must provide notice to EPA that includes the following: (A) Identification of the conditions of use detailed in paragraph (b)(1)(i) of this section that the emergency use fell under; (B) An explanation for why the emergency use met the definition of emergency in paragraph (b)(1)(ii)(A) of this section; and (C) An explanation of why perchloroethylene was selected, including why there were no technically and economically feasible safer alternatives available in the particular emergency. (ii) Exposure control. The owner or operator must comply with the Workplace Chemical Protection Program provisions in § 751.607, to the extent technically feasible in light of the particular emergency. (iii) Recordkeeping. The owner or operator of the location where the use takes place must comply with the recordkeeping requirements in § 751.613. [FR Doc. 2023–12495 Filed 6–15–23; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\16JNP3.SGM 16JNP3

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Proposed Rules]
[Pages 39652-39723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12495]



[[Page 39651]]

Vol. 88

Friday,

No. 116

June 16, 2023

Part IV





Environmental Protection Agency





-----------------------------------------------------------------------





40 CFR Part 751





Perchloroethylene (PCE); Regulation under the Toxic Substances Control 
Act (TSCA); Proposed Rule

Federal Register / Vol. 88 , No. 116 / Friday, June 16, 2023 / 
Proposed Rules

[[Page 39652]]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0720; FRL-8329-02-OCSPP]
RIN 2070-AK84


Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to 
address the unreasonable risk of injury to human health presented by 
perchloroethylene (PCE) under its conditions of use as documented in 
EPA's December 2020 Risk Evaluation for PCE and December 2022 revised 
risk determination for PCE prepared under the Toxic Substances Control 
Act (TSCA). PCE is a widely used solvent in a variety of occupational 
and consumer applications including fluorinated compound production, 
petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA 
determined that PCE presents an unreasonable risk of injury to health 
due to the significant adverse health effects associated with exposure 
to PCE, including neurotoxicity effects from acute and chronic 
inhalation exposures and dermal exposures, and cancer from chronic 
inhalation exposures to PCE. 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 the chemical no longer presents unreasonable risk. PCE, also known 
as perc and tetrachloroethylene, is a neurotoxicant and a likely human 
carcinogen. Neurotoxicity, in particular impaired visual and cognitive 
function and diminished color discrimination, are the most sensitive 
adverse effects driving the unreasonable risk of PCE, and other adverse 
effects associated with exposure include central nervous system 
depression, kidney and liver effects, immune system toxicity, 
developmental toxicity, and cancer. To address the identified 
unreasonable risk, EPA is proposing to prohibit most industrial and 
commercial uses of PCE; the manufacture (including import), processing, 
and distribution in commerce of PCE for the prohibited industrial and 
commercial uses; the manufacture (including import), processing, and 
distribution in commerce of PCE for all consumer use; and, the 
manufacture (including import), processing, distribution in commerce, 
and use of PCE in dry cleaning and related spot cleaning through a 10-
year phaseout. For certain conditions of use that would not be subject 
to a prohibition, EPA is also proposing to require a PCE workplace 
chemical protection program that includes requirements to meet an 
inhalation exposure concentration limit and prevent direct dermal 
contact. EPA is also proposing to require prescriptive workplace 
controls for laboratory use, and to establish recordkeeping and 
downstream notification requirements. Additionally, EPA proposes to 
provide certain time-limited exemptions from requirements for certain 
critical or essential emergency uses of PCE for which no technically 
and economically feasible safer alternative is available.

DATES: Comments must be received on or before August 15, 2023. Under 
the Paperwork Reduction Act (PRA), comments on the information 
collection provisions are best assured of consideration if the Office 
of Management and Budget (OMB) receives a copy of your comments on or 
before July 17, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0720, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets/.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kelly Summers, Existing 
Chemicals Risk Management Division, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number (202) 564-2201; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by the proposed action if you 
manufacture (defined under TSCA to include import), process, distribute 
in commerce, use, or dispose of PCE or products containing 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 applies 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).

[[Page 39653]]

     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).

[[Page 39654]]

     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).
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final TSCA section 6(a) 
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements and the corresponding regulations at 19 CFR 
12.118 through 12.127; see also 19 CFR 127.28. Those persons must 
certify that the shipment of the chemical substance complies with all 
applicable rules and orders under TSCA. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed 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.
    If you have any questions regarding the applicability of this 
proposed action to a particular entity, consult the technical 
information contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S. 
Environmental Protection Agency hereinafter EPA or ``the Agency,'' 
determines through a TSCA section 6(b) risk evaluation that a chemical 
substance presents an unreasonable risk of injury to health or the 
environment, EPA must by rule apply one or more requirements listed in 
TSCA section 6(a) to the extent necessary so that the chemical 
substance or mixture no longer presents such risk.

C. What action is the Agency taking?

    Pursuant to TSCA section 6(b), EPA determined that 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). The term ``conditions of use'' is defined at TSCA 
section 3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which 
a chemical substance is intended, known, or reasonably foreseen to be 
manufactured, processed, distributed in commerce, used, or disposed of. 
A detailed description of the conditions of use that drive EPA's 
determination that PCE presents an unreasonable risk is included in 
Unit III.B.1. EPA notes that all TSCA conditions of use of PCE are 
subject to this proposal. Accordingly, to address the unreasonable 
risk, EPA is proposing, 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.A.1.;
    (ii) Prohibit the manufacture (including import), processing, and 
distribution in commerce of PCE for all consumer use, outlined in Unit 
IV.A.1.;
    (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.A.1.;
    (iv) Require strict workplace controls, including a PCE Workplace 
Chemical Protection Program (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, outlined in Unit IV.A.2.;
    (v) Require prescriptive workplace controls for laboratory use, 
outlined in Unit IV.A.3.; and
    (vi) Establish recordkeeping and downstream notification 
requirements, outlined in Unit IV.A.4.
    (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 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.A.5.
    In addition, EPA is proposing to amend the general provision of 40 
CFR part 751, subpart A, to define ``authorized person,'' ``direct 
dermal contact,'' ``ECEL,'' ``exposure group,'' ``owner or operator,'' 
``potentially exposed person,'' ``regulated area,'' and ``retailer'' 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. EPA 
seeks public comment on all aspects of this proposed rule.

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. As a result, EPA is proposing to 
take action to the extent necessary so that PCE no longer presents such 
risk. The unreasonable risk is described in Unit III.B.2. and the 
conditions of use that drive the unreasonable risk for PCE are 
described in Unit III.B.1.

[[Page 39655]]

    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 
proposed rule is neurotoxicity, 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. The most sensitive endpoint is 
dependent on both the point of departure (POD) and the associated total 
uncertainty factor. 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 proposed rulemaking, 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 proposed 
rule would 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.
    EPA is not proposing 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 rule proposes to allow 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 phasedown 
under the AIM Act. While HFC-125 and HFC-134a are two of the regulated 
substances subject to the phasedown in production and consumption by 
85% over the next 15 years, 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 from certain other HFCs 
and 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 and 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 U.S. gasoline pool. 
Therefore, this rule proposes to allow 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 proposing strict 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 
proposed in this rulemaking or to prevent direct dermal contact with 
PCE.
    Accordingly, EPA is proposing strict workplace controls to address 
the unreasonable risk and allow continued use of PCE for several 
conditions of use, including for processing as a reactant/intermediate, 
use in vapor degreasing, use as a maskant for chemical milling, use in 
adhesives and sealants, use as a processing aid in catalyst 
regeneration in petrochemical manufacturing, and use as a laboratory 
chemical, which comprise more than an estimated 80% of the current 
production volume of PCE. EPA is proposing to ban or phaseout most 
conditions of use of PCE, including use in dry cleaning and spot 
cleaning, 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 would not be 
prohibited, EPA 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. Unit IV.A. describes EPA's proposed regulatory action 
and Unit IV.B. describes the alternative regulatory actions as required 
under TSCA section 6(c)(2)(A). The rationale for the proposed 
regulatory action and alternative regulatory actions, including the 
TSCA section 6 requirements considered in developing the regulatory 
actions, is described in Units III.B.3. and V.

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 VI.D. and X.D., EPA was unable to 
quantify all incremental costs of this proposed rule. The quantifiable 
cost of the proposed rule is estimated to be $14.0 million annualized 
over 20 years at a 3% discount rate and $14.3 million annualized over 
20 years at a 7% discount rate. These costs take compliance with 
implementation of a WCPP into consideration, which would include an 
existing chemical exposure limit (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 most notable unquantified costs include possible 
costs from prohibition of use of PCE as a processing aid outside of the 
petrochemical industry; EPA's analysis was unable to quantify these 
costs, as described more fully in section 7.11 in the Economic Analysis 
(Ref. 3). The economic impact on users of PCE for chemical milling and 
vapor degreasing is also unclear because there are no clear 
alternatives to PCE; these users might have to use PPE to meet the 
requirements of a WCPP for PCE.

[[Page 39656]]

Chemical milling using PCE is most prominent in the aerospace industry. 
Vapor degreasing is used in several advanced manufacturing industries, 
including aerospace, automotive, energy, medical devices, and others 
(Ref. 3).
    In addition, EPA estimates that 6,000 dry cleaners still use PCE, a 
majority of which are small businesses. Nevertheless, despite 
information EPA has sought from stakeholders, it is still unclear as to 
the impact of a prohibition of PCE for dry cleaning through a gradual 
phaseout; EPA has not been able to estimate the number of dry cleaning 
facility closures that may be associated with this phaseout. More 
information on the challenges of estimating these impacts, in part due 
to the age of relevant machines in use, is in the Economic Analysis 
(Ref. 3). 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 
proposed 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 7-10 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 is generalizable to other states; industry has 
informed the Agency that very few PCE machines have been purchased in 
recent years. Based on the estimated revenues per firm presented in 
Table 31 of the Economic Analysis and the 6,000 estimated number of dry 
cleaning firms using PCE as dry cleaning solvent (see section 6.1.5 (A) 
of the Economic Analysis), the total revenue for dry cleaning firms 
using PCE as dry cleaning solvent is approximately $3.1 billion. 
According to IRS (2013) data, profit in this sector is about 4.8% of 
sales, implying that total profit of firms using PCE as dry cleaning 
solvent is about $148 million. However, EPA has proposed a 10-year 
phaseout of PCE in dry cleaning and estimates that only about 60 PCE 
dry cleaning machines would remain at the end of the phaseout (see 
section 7.7.3. of the Economic Analysis). This suggests that the 
proposed option would only affect about $31 million of the industry's 
total revenue and about $1.5 million of the industry's profit. Many of 
these firms would likely choose to purchase non-PCE machines or become 
drop shops (do dry cleaning at another site) rather than close. A 
detailed sensitivity analysis of varying assumptions on ages of PCE dry 
cleaning machines and PCE dry cleaning machine life is provided in 
section 11 of the Economic Analysis.
    The actions proposed in this 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 proposed rule are approximately $10.2 
million to $46.3 million annualized over 20 years at a 3% discount rate 
and $4.72 million to $29.4 million annualized over 20 years at a 7% 
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 of PCE in human 
studies include visual deficits, impaired cognition, and decreased math 
scores. Also, prenatal and early childhood exposure to PCE in drinking 
water are associated with increases in drug, alcohol, and tobacco use 
(Ref. 1). Reductions in PCE exposure are therefore likely to be 
associated with large dollar-valued, but currently unmonetized, 
benefits.
    Additionally, the Agency expects that the proposed dry cleaning 
phaseout will decrease health risks for affected populations that may 
own/operate or work at dry cleaning facilities. 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). Based on reasonably 
available information, the Agency understands that a significant number 
of members of minority populations may own or work at dry cleaning 
facilities.

II. Background

A. Overview of Perchloroethylene

    This proposed 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 
III.B.2. 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 further detail in Unit III.B.1., 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 U.S. decreased from 388 million pounds 
to around 324 million pounds between 2012 and 2015 (Ref. 4). The total 
aggregate annual production volume ranged from 250 to 500 million 
pounds between 2016 and 2019 according to CDR (Ref. 5).

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 other Federal, state, and 
international regulations (Ref. 6) is in the docket and in Appendix A 
of the 2020 Risk Evaluation for PCE (Ref. 1).

C. Consideration of Occupational Safety and Health Administration 
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA 
Risk Management Actions

    Although EPA must consider and factor in, to the extent 
practicable, certain nonrisk factors as part of TSCA section 6(a) 
rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still 
ensure that the selected regulatory requirements apply ``to the extent 
necessary so that the chemical substance or mixture no longer presents 
[unreasonable] risk.'' 15 U.S.C. 2605(a). This requirement to eliminate 
unreasonable risk is distinguishable from approaches mandated by some 
other laws, including the Occupational Safety and Health Act (OSH Act), 
which includes both significant risk and feasibility (technical and 
economic) considerations in the setting of standards.
    Congress intended for EPA to consider occupational risks from 
chemicals it evaluates under TSCA, among other potential exposures, as 
relevant and appropriate. As noted previously, TSCA section 6(b) 
requires EPA to evaluate risks to PESS identified as relevant by the 
Administrator. TSCA section 3(12) defines the term ``potentially 
exposed or susceptible subpopulation'' as ``a group of individuals 
within the general population identified by the Administrator who, due 
to either greater

[[Page 39657]]

susceptibility or greater exposure, may be at greater risk than the 
general population of adverse health effects from exposure to a 
chemical substance or mixture, such as infants, children, pregnant 
women, workers, or the elderly.''
    The OSH Act similarly requires OSHA to evaluate risk specific to 
workers prior to promulgating new or revised standards and requires 
OSHA standards to substantially reduce significant risk to the extent 
feasible, even if workers are exposed over a full working lifetime. See 
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum 
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
    Thus, the standards for chemical hazards that OSHA promulgates 
under the OSH Act share a broadly similar purpose with the standards 
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, as this 
section outlines, 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 (Ref. 6) when evaluating and addressing potential 
unreasonable risk to workers so that compliance requirements are 
clearly explained to the regulated community.
1. OSHA Requirements
    OSHA's mission is to ensure that employees work in safe and 
healthful conditions. The OSH Act establishes requirements that each 
employer comply with the General Duty Clause of the Act (29 U.S.C. 
654(a)), as well as with occupational safety and health standards 
issued under the Act.
a. General Duty Clause of the OSH Act
    The General Duty Clause of the OSH Act requires employers to keep 
their workplaces free from recognized hazards that are causing or are 
likely to cause death or serious physical harm to employees. The 
General Duty Clause is cast in general terms, and does not establish 
specific requirements like exposure limits, PPE, or other specific 
protective measures that EPA could potentially consider when developing 
its risk evaluations or risk management requirements. OSHA, under 
limited circumstances, has cited the General Duty Clause for regulating 
exposure to chemicals. To prove a violation of the General Duty Clause, 
OSHA must prove employer or industry recognition of the hazard, that 
the hazard was causing or likely to cause death or serious physical 
harm, and a feasible method to eliminate or materially reduce the 
hazard was available. In rare situations, OSHA has cited employers for 
violation of the General Duty Clause where exposures were below a 
chemical-specific permissible exposure limit (PEL), a TWA based on an 
employee's average airborne exposure in any 8-hour work shift of a 40-
hour work week which shall not be exceeded (Ref. 7). In such 
situations, OSHA must demonstrate that the employer had actual 
knowledge that the PEL was inadequate to protect its employees from 
death or serious physical harm. Because of the heavy evidentiary burden 
on OSHA to establish violations of the General Duty Clause, it is not 
frequently used to cite employers for employee exposure to chemical 
hazards.
b. OSHA Standards
    OSHA standards are issued pursuant to the OSH Act and are found in 
title 29 of the CFR. There are separate standards for general industry, 
laboratories, construction, maritime and agriculture sectors, and 
general standards applicable to a number of sectors (e.g., OSHA's 
Respiratory Protection standard). OSHA has numerous standards that 
apply to employers who operate chemical manufacturing and processing 
facilities, as well as to downstream employers whose employees may be 
occupationally exposed to hazardous chemicals.
    OSHA sets legally enforceable limits on the airborne concentrations 
of hazardous chemicals, referred to as PELs, established for employers 
to protect their workers against the health effects of exposure to 
hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart 
Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, 
OSHA was permitted an initial 2-year window after the passage of the 
Act to adopt ``any national consensus standard and any established 
Federal standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971 
to establish PELs that were adopted from Federal health standards 
originally set by the Department of Labor through the Walsh-Healy Act, 
in which approximately 400 occupational exposure limits (OELs) were 
selected based on the American Conference of Governmental Industrial 
Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In 
addition, about 25 exposure limits recommended by the American 
Standards Association (now called the American National Standards 
Institute or ANSI) were adopted as PELs.
    Following the 2-year window provided under section 6(a) of the OSH 
Act for adoption of national consensus and existing Federal standards, 
OSHA has issued health standards following the requirements in section 
6(b) of the Act. OSHA has established approximately 30 PELs under 
section 6(b)(5) as part of comprehensive substance-specific standards 
that include additional requirements for protective measures such as 
use of PPE, establishment of regulated areas, exposure assessment, 
hygiene facilities, medical surveillance, and training. These ancillary 
provisions in substance-specific OSHA standards further mitigate 
residual risk that could be present due to exposure at the PEL.
    Many OSHA PELs have not been updated since they were established in 
1971, including the PEL for PCE. In many instances, scientific evidence 
has accumulated suggesting that the current limits of many PELs are not 
sufficiently protective. On October 10, 2014, OSHA published a Federal 
Register document in which it recognized that many of its PELs are 
outdated and inadequate for ensuring protection of worker health (79 FR 
61384). 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. As described in that notice, while new advancements or 
developments in science and technology from the time a PEL is 
promulgated may improve the scientific basis for making findings of 
significant risk, technical feasibility or economic feasibility, OSHA 
has been unable to update most of the PELs established in 1971 and they 
remain frozen at levels at which they were initially adopted (79 FR 
61384, October 10, 2014). One example of how industries have evolved in 
the intervening 50 years as to what is technologically and economically 
feasible is the halogenated solvent cleaning industry, which, in 
response to EPA's National Emission Standards for Hazardous Air 
Pollutants (NESHAP) promulgated under section 112 of the 1990 Clean Air 
Act Amendments (see National Emissions Standards for Halogenated 
Solvent Cleaning, 40 CFR part 63, subpart T), has made equipment

[[Page 39658]]

improvements that conserve solvent resources and reduce workplace 
exposure.
    In sum, the great majority of OSHA's chemical standards are 
outdated or do not sufficiently reduce 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, and because many of OSHA's chemical-
specific standards are based on outdated information regarding the 
technological and economic feasibility of the standards and the risks 
associated with exposure, 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. However, it is also appropriate that EPA 
consider the chemical standards that OSHA has already developed to 
limit the compliance burden to employers by aligning management 
approaches required by the agencies, where alignment will adequately 
address unreasonable risk to workers. The following unit discusses 
EPA's consideration of OSHA standards in its risk evaluation and 
management strategies under TSCA.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
    When characterizing the risk during risk evaluation under TSCA, EPA 
believes it is appropriate to evaluate the levels of risk present in 
scenarios where no mitigation measures are assumed to be in place for 
the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It 
should be noted that there are some cases where scenarios may reflect 
certain mitigation measures, such as in instances where exposure 
estimates are based on monitoring data at facilities that have existing 
engineering controls in place. For example, the Halogenated Solvent 
Cleaning NESHAP, first promulgated in 1994 and last updated in 2007, 
established standards reflecting the maximum achievable control 
technology for major and certain area sources, standards reflecting 
generally available control technology for other area sources, and 
facility-wide emission limits for certain halogenated solvent cleaning 
machines. Consequently, emissions monitoring from facilities meeting 
the NESHAP would reflect emissions reduction resulting from existing 
engineering controls already in place to meet the standards.)
    In addition, EPA believes it may be appropriate to also evaluate 
the levels of risk present in scenarios considering applicable OSHA 
requirements as well as scenarios considering industry or sector best 
practices for industrial hygiene that are clearly articulated to the 
Agency. EPA may evaluate risk under scenarios that consider industry or 
sector best practices for industrial hygiene that are clearly 
articulated to the Agency, when doing so serves to inform its risk 
management efforts. Characterizing risks using scenarios that reflect 
different levels of mitigation can help inform potential risk 
management actions by providing information that could be used during 
risk management to tailor risk mitigation appropriately to address any 
unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).
a. Risk Characterization for Unreasonable Risk Determination
    When making unreasonable risk determinations as part of TSCA risk 
evaluations, EPA cannot assume as a general matter that all workers are 
always equipped with and appropriately using sufficient PPE, although 
it does not question the veracity of public comments received on the 
2020 Risk Evaluation for PCE regarding the occupational safety 
practices often followed by industry respondents. When characterizing 
the risk to human health from occupational exposures during risk 
evaluation under TSCA, EPA believes it is appropriate to evaluate the 
levels of risk present in scenarios where PPE is not assumed to be used 
by workers. This approach of not assuming PPE use by workers considers 
the risk to PESS (workers and occupational non-users (ONUs)) who may 
not be covered by OSHA standards, such as self-employed individuals and 
public sector workers who are not covered by a State Plan. Mitigation 
scenarios included in the EPA risk evaluation in order to inform its 
risk management efforts (e.g., scenarios considering use of PPE) likely 
represent current practice in many facilities where companies 
effectively address worker and bystander safety requirements. However, 
the Agency cannot assume that all facilities across all uses of the 
chemical substance will have adopted these practices for the purposes 
of making the TSCA risk determination.
    Therefore, EPA makes its determinations of unreasonable risk based 
on scenarios that do not assume compliance with OSHA standards, 
including any applicable exposure limits or requirements for use of 
respiratory protection or other PPE. Making unreasonable risk 
determinations based on such scenarios should not be viewed as an 
indication that EPA believes there are no occupational safety 
protections in place at any location, or that there is widespread 
noncompliance with applicable OSHA standards. Rather, it reflects EPA's 
recognition that unreasonable risk may exist for subpopulations of 
workers that may be highly exposed because they are not covered by OSHA 
standards, such as self-employed individuals and public sector workers 
who are not covered by an OSHA State Plan, or because their employer is 
out of compliance with OSHA standards, or because EPA finds 
unreasonable risk for purposes of TSCA notwithstanding existing OSHA 
requirements.
b. Risk Evaluation To Inform Risk Management Requirements
    In addition to the scenarios described previously, EPA risk 
evaluations may characterize the levels of risk present in scenarios 
considering applicable OSHA requirements (e.g., chemical-specific PELs 
and/or chemical-specific health standards with PELs and additional 
ancillary provisions) as well as scenarios considering industry or 
sector best practices for industrial hygiene that are clearly 
articulated to the Agency to help inform risk management decisions.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
    When undertaking risk management actions, EPA: (1) Develops 
occupational risk mitigation measures to address any unreasonable risk 
identified by EPA, striving for consistency with applicable OSHA 
requirements and industry best practices, including appropriate 
application of the hierarchy of controls (Ref. 8), when those measures 
would address an unreasonable risk; and (2) Ensures that EPA 
requirements apply to all potentially exposed workers in accordance 
with TSCA requirements.

[[Page 39659]]

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 applicability of TSCA while avoiding 
the imposition of duplicative requirements.
    Informed by the mitigation scenarios and information gathered 
during the risk evaluation and risk management process, the Agency 
might propose rules that require risk management practices that may be 
already common practice in many or most facilities. Adopting clear, 
broadly applicable regulatory standards will foster compliance across 
all facilities (ensuring a level playing field) and assure protections 
for all affected workers, especially in cases where current OSHA 
standards may not apply to them or not be sufficient to address the 
unreasonable risk.
    For evaluation scenarios which involve OSHA chemical-specific PELs, 
EPA's risk evaluation in some cases may illustrate that limiting 
exposure to OSHA's PEL would result in acceptable levels of risk under 
TSCA under certain conditions of use. In these cases, TSCA risk 
management requirements could incorporate and reinforce requirements in 
OSHA standards and ensure that risks are addressed, including for 
circumstances where OSHA requirements are not applicable (e.g., public 
sector workers not covered by an OSHA State plan, and self-employed 
workers) by asserting TSCA compliance/enforcement as well. EPA's risk 
evaluation may also find unreasonable risk under TSCA associated with 
some occupational conditions of use, even when the applicable OSHA 
requirements are being met. In these cases, EPA would need to develop 
risk management requirements beyond those included in OSHA's standards.
4. PCE and OSHA Requirements
    EPA incorporated the considerations described earlier in this unit 
in the 2020 Risk Evaluation for PCE, the December 2022 revised 
unreasonable risk determination for PCE, and this rulemaking. 
Specifically, in the TSCA 2020 Risk Evaluation for PCE, EPA presented 
risk estimates based on workers' exposures with and without respiratory 
protection. EPA determined that even when respirators are used by 
workers, most of the conditions of use evaluated presented an 
unreasonable risk. Additional consideration of OSHA standards in the 
revised unreasonable risk determination is discussed further in the 
Federal Register notice announcing that document (Ref. 9). In Units 
III.B.3. and Unit V., EPA outlines the importance of considering the 
hierarchy of controls utilized by the industrial hygiene community 
(hereafter referred to as ``hierarchy of controls'') when developing 
risk management actions in general, and specifically when determining 
if and how regulated entities may meet a risk-based exposure limit for 
PCE. The hierarchy of controls is a prioritization of exposure control 
strategies from most protective and preferred to least protective and 
preferred techniques. In order of precedence, they are: elimination of 
the hazard, substitution with a less hazardous substance, engineering 
controls, administrative controls such as training or exclusion zones 
with warning signs, and, finally, use of PPE (Ref. 8). Under the 
hierarchy of controls the use of respirators (and all PPE) should only 
be considered after all other measures have been taken to reduce 
exposures. As discussed in Units IV.A. and V.A.1., EPA's risk 
management approach would not rely solely or primarily on the use of 
respirators and dermal PPE to address unreasonable risk to workers; 
instead, EPA is proposing prohibitions for most conditions of use and a 
WCPP for certain occupational conditions of use. The WCPP would require 
consideration of the hierarchy of controls before use of respirators 
and other PPE. The WCPP is discussed in full in Units IV.A.2. and 
V.A.1.b.
    In accordance with the approach described earlier in Unit II.C.3., 
EPA intends for this regulation to be as consistent as possible with 
the existing OSHA standards, with additional requirements as necessary 
to address the unreasonable risk. One notable difference between the 
WCPP and the OSHA standards are the exposure limits. The WCPP would 
include an ECEL of 0.14 ppm as an 8-hour TWA to address unreasonable 
risk for chronic cancer and non-cancer and acute non-cancer inhalation 
endpoints. EPA recognizes that for PCE, the ECEL would be significantly 
lower than the OSHA PEL (100 ppm as an 8-hour TWA). In addition to the 
distinctions in statutory requirements described in this unit, EPA has 
identified several factors contributing to the differences in these 
levels, outlined here.
    The TSCA ECEL value for PCE is a lower value than the OSHA PEL (and 
other existing OELs, discussed in Unit II.C.5.) for many reasons, 
including the age of the data and studies the values are based on and 
that the values may not fully capture either the complete database of 
studies considered in the 2020 Risk Evaluation for PCE or more recent 
advances in modeling and scientific interpretation of toxicological 
data applied in the calculation of the PCE ECEL. EPA considers the PCE 
ECEL to represent the best available science under TSCA section 26(h) 
because it was derived from information in the 2020 Risk Evaluation for 
PCE, which was subject to peer review, and which is the result of a 
systematic review process that investigated the reasonably available 
information in order to identify relevant adverse health effects. 
Additionally, by using the information from the 2020 Risk Evaluation 
for PCE, the ECEL incorporates advanced modeling and peer-reviewed 
methodologies, and accounts for exposures to potentially exposed and 
susceptible subpopulations, as required by TSCA.
    For PCE, the EPA ECEL is an 8-hour occupational inhalation exposure 
limit based on chronic non-cancer neurotoxicity effects, and takes into 
consideration the uncertainties identified in the 2020 Risk Evaluation 
for PCE (Ref. 10). The ECEL represents the concentration at which an 
adult human, including a member of a PESS, would be unlikely to suffer 
adverse effects if exposed for a working lifetime. EPA has determined 
as a matter of risk management policy that ensuring exposures remain at 
or below the ECEL will eliminate any unreasonable risk of injury to 
health from occupational inhalation exposures. In addition to the ECEL, 
as part of this rulemaking EPA is proposing an ECEL action level, a 
value half of the ECEL, that would trigger additional monitoring to 
ensure that workers are not exposed to concentrations above the ECEL.
    For PCE, the ECEL of 0.14 ppm is based on the most sensitive point 
of departure across acute, chronic non-cancer, and cancer endpoints. 
Neurotoxicity based on visual and cognitive deficits following chronic 
exposure was the basis of the PCE ECEL based on epidemiological data 
from Cavalleri et al., 1994 and Echeverria et al., 1995 (Refs. 10, 1, 
11, 12). The ECEL incorporates a benchmark margin of exposure of 100 to 
account for human variability and the absence of a no-effect level in 
the studies.
    The OSHA PEL for PCE of 100 ppm as an 8-hour TWA was established in 
1971. OSHA is required to promulgate a standard that reduces 
significant risk to the extent that it is technologically and 
economically feasible to do so (81 FR 16285). A 1989 update to 25 ppm 
based on a quantitative cancer risk assessment and technological 
feasibility analysis was later vacated by court order, reverting to the 
original PEL of 100 ppm (Ref. 13); (See also 54 FR 2332, 2686, 2688 
(1989)). The basis of the 100

[[Page 39660]]

ppm PEL is unclear, however most original PELs were based on acute 
health effects only observable at higher concentrations as more 
sensitive chronic studies, including the chronic exposure studies used 
to inform the PCE ECEL, were not available at the time the PEL was 
established (see, e.g., 79 FR 61383, 61388). As discussed in Units 
II.D., III.B., and VII.D., the TSCA ECEL represents the best available 
science at time of publication of the 2020 Risk Evaluation for PCE. As 
described earlier, in a 2014 request for information OSHA described 
how, while new developments in science and technology from the time the 
PEL for PCE was established in 1971 may improve the scientific basis 
for making findings of significant risk, technical feasibility, or 
economic feasibility that is required under section 6(b)(5) of the OSH 
Act, OSHA has been unable to update the PEL for PCE and it remains 
frozen at the level that was originally adopted in 1971 (79 FR 61383, 
October 10, 2014).
5. PCE and Other Occupational Exposure Limits
    EPA is aware of other OELs for PCE, including the ACGIH TLV, the 
California Division of Occupational Safety and Health (Cal/OSHA) PEL, 
and the National Institute for Occupational Safety and Health (NIOSH) 
Recommended Exposure Limit (REL).
    The 8-hour TWA TLV recommended by the ACGIH is 25 ppm. This TLV is 
based on ``discomfort and subjective complaints'' occurring at 100 ppm 
and above (Ref. 14). Neurological effects such as dizziness, headache, 
sleepiness, and incoordination were also indicated at 100 ppm and 
above. The TLV appears to use a four-fold ``margin of safety'' 
consistent with other TLV reports but lower than what would be 
recommended by EPA guidance (Ref. 15), which would support a downward 
adjustment of 30x-100x. The TLV report acknowledges that the liver 
effects were observed at as low as 9 ppm in mice after only 30 days of 
continuous exposure, however ACGIH determined that the exposure pattern 
was not representative of occupational scenarios. Additionally, 
quantitative risks from cancer were not considered because PCE was 
classified as only an animal carcinogen. Notably, the TLV report did 
not cite either epidemiological study used as the basis of the EPA 
ECEL, despite them being published 1-2 years prior to the 1996 TLV 
update.
    The Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and equivalent 
to the ACGIH TLV. The 25 ppm value is also equivalent to the vacated 
1989 OSHA PEL, which was based on a quantitative cancer risk assessment 
and technological feasibility analysis. Despite the Cal/OSHA PEL being 
equivalent to the vacated 1989 OSHA PEL based on cancer, Cal/OSHA did 
not perform a quantitative cancer risk assessment and the PEL is 
primarily based on non-cancer central nervous systems (CNS) effects 
(Ref. 16).
    In 1976, the NIOSH REL for PCE was 50 ppm as a TWA for up to a 10-
hour workday, 40-hour workweek (Ref. 17). This REL was considered 
protective of neurological effects as well as eye and respiratory tract 
irritation. The current REL for PCE is ``Ca (potential occupational 
carcinogen) minimize workplace exposure concentrations'' (Ref. 18). As 
described in NIOSH's Appendix A, this non-quantitative value is based 
on the lowest feasible concentration (Ref. 19).

D. Summary of EPA's Risk Evaluation Activities on PCE

    In December 2016, EPA selected PCE as one of the first 10 chemicals 
for risk evaluation under TSCA section 6 (15 U.S.C. 2605). EPA 
published the scope of the PCE risk evaluation in June 2017 (82 FR 
31592, July 7, 2017) (FRL-9963-57), and, after receiving public 
comments, published the problem formulation in June 2018 (83 FR 26998, 
June 11, 2018) (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 Evaluationfor 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 Unreasonable Risk Determination for PCE (87 FR 
76481, December 14, 2022) (FRL-9942-01-OCSPP). The 2020 Risk Evaluation 
for PCE and supplemental materials are in docket EPA-HQ-OPPT-2019-0502, 
with the December 2022 revised unreasonable risk determination and 
additional materials supporting the risk evaluation process in docket 
EPA-HQ-OPPT-2016-0732, on https://www.regulations.gov.
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. Descriptions of these 
conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for PCE 
identified significant adverse health effects associated with exposure 
to PCE, including neurotoxicity effects from acute and chronic 
inhalation exposures and dermal exposures, and cancer from chronic 
inhalation exposures to PCE. A further discussion of the hazards of PCE 
is in Unit III.B.2.
2. Revised Unreasonable Risk Determination
    EPA has been revisiting specific aspects of its first ten TSCA 
existing chemical risk evaluations, including the 2020 Risk Evaluation 
for PCE, to ensure that the risk evaluations upon which risk management 
decisions are made better align with TSCA's objective of protecting 
human health and the environment. For PCE, 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 (entitled ``Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis'') and 
other Administration priorities (Refs. 20, 21, and 22). The revisions 
consisted of making the risk determination based on the whole chemical 
substance instead of by individual conditions of use (which resulted in 
the revised risk determination superseding the prior ``no unreasonable 
risk'' determinations and withdrawing the associated TSCA section 
6(i)(1) ``no unreasonable risk'' order); and clarifying that the risk 
determination does not reflect an assumption that all workers are 
always provided and appropriately wear PPE (Ref. 2).
    In determining whether PCE presents unreasonable risk under the 
conditions of use, EPA considered relevant risk-related factors, 
including, but not limited to: the effects of the chemical substance on 
health (including cancer and non-cancer risks) and human exposure to 
the substance under the conditions of use (including duration, 
magnitude and frequency of exposure); the effects of the chemical 
substance on the environment and environmental exposure under the 
conditions of use; the population exposed (including any PESS); the 
severity of hazard (including the nature of the hazard, the

[[Page 39661]]

irreversibility of the hazard); and uncertainties.
    EPA determined that PCE presents an unreasonable risk of injury to 
health. The unreasonable risk determination is driven by risks to 
workers and ONUs (workers who do not directly handle the chemical but 
perform work in an area where the chemical is present) due to 
occupational exposures to PCE (i.e., during manufacture, processing, 
industrial and commercial uses, or disposal); to children of employees 
at dry cleaning facilities due to PCE exposures at those facilities; 
and to consumers and bystanders associated with consumer uses of PCE 
due to exposures from consumer use of PCE and PCE-containing products. 
EPA did not identify risks of injury to the environment that drive the 
unreasonable risk determination for PCE. The PCE conditions of use that 
drive 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., with descriptions to 
aid chemical manufacturers, processors, and users in determining how 
their particular use or activity would be addressed under the proposed 
regulatory provisions.
    While the 2020 Risk Evaluation for PCE estimated different risks 
for occupational non-users and workers, the benchmark (and thus the 
ECEL value) is the same for both populations. That is, while workers 
and occupational non-users may have different exposure patterns, the 
level of exposure such that risks are no longer unreasonable is the 
same for both workers and occupational non-users. Thus, for the 
purposes of risk management, the distinction between worker and 
occupational non-user is no longer relevant, and both are encompassed 
by the definition of a potentially exposed person, as outlined in Unit 
IV.A.2.a.
3. Fenceline Screening Analysis
    The 2020 Risk Evaluation for PCE excluded the assessment of certain 
exposure pathways that were or could be regulated under another EPA-
administered statute (see section 1.4.2 of the December 2020 Risk 
Evaluation for PCE) (Refs. 1, 2). This resulted in the surface water, 
drinking water, and ambient air pathways for PCE exposure not being 
assessed for human health risk to the general population. In June 2021, 
EPA made a policy announcement on the path forward for TSCA chemical 
risk evaluations, indicating that EPA would, among other things, 
examine whether the exclusion of certain exposure pathways from the 
risk evaluations would lead to a failure to identify and protect 
fenceline communities (Refs. 9, 23). EPA then conducted a screening 
analysis to identify whether there may be potential risks to people 
living near the fenceline of facilities releasing PCE.
    In order to assess the potential risk to the general population in 
proximity to a facility releasing PCE, EPA developed the TSCA Screening 
Level Approach for Assessing Ambient Air and Water Exposures to 
Fenceline Communities Version 1.0, which was presented to the SACC in 
March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 24). 
This analysis is discussed in Unit VI.A.

III. Regulatory Approach

A. Background

    Under TSCA section 6(a), if the Administrator determines through a 
TSCA section 6(b) risk evaluation that the manufacture (including 
import), processing, distribution in commerce, use, or disposal of a 
chemical substance or mixture, or any combination of such activities, 
presents an unreasonable risk of injury to health or the environment, 
EPA must by rule apply one or more of the following requirements to the 
extent necessary so that the chemical substance or mixture no longer 
presents such risk.
     Prohibit or otherwise restrict the manufacturing, 
processing, or distribution in commerce of the substance or mixture, or 
limit the amount of such substance or mixture which may be 
manufactured, processed, or distributed in commerce (TSCA section 
6(a)(1)).
     Prohibit or otherwise restrict the manufacturing, 
processing, or distribution in commerce of the substance or mixture for 
a particular use or above a specific concentration for a particular use 
(TSCA section 6(a)(2)).
     Limit the amount of the substance or mixture which may be 
manufactured, processed, or distributed in commerce for a particular 
use or above a specific concentration for a particular use specified 
(TSCA section 6(a)(2)).
     Require clear and adequate minimum 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 
(TSCA section 6(a)(3)).
     Require manufacturers and processors of the substance or 
mixture to make and retain certain records, or conduct certain 
monitoring or testing (TSCA section 6(a)(4)).
     Prohibit or otherwise regulate any manner or method of 
commercial use of the substance or mixture (TSCA section 6(a)(5)).
     Prohibit or otherwise regulate any manner or method of 
disposal of the substance or mixture, or any article containing such 
substance or mixture, by its manufacturer or processor or by any person 
who uses or disposes of it for commercial purposes (TSCA section 
6(a)(6)).
     Direct manufacturers or processors of the substance or 
mixture to give notice of the unreasonable risk determination to 
distributors, certain other persons, and the public, and to replace or 
repurchase the substance or mixture (TSCA section 6(a)(7)).
    As described in Unit III.B.3., EPA analyzed how the TSCA section 
6(a) requirements could be applied to address the unreasonable risk 
found to be present in the 2020 Risk Evaluation for PCE and the final 
revised unreasonable risk determination, so that PCE no longer presents 
such unreasonable risk. EPA's proposed regulatory action and two 
alternative regulatory actions are described in Unit IV. EPA is 
requesting public comment on all elements of the proposed regulatory 
action and the alternative regulatory actions and is providing notice 
that based on consideration of comments and any new information 
submitted to EPA during the comment period on this proposed rule, EPA 
may in the final rule modify elements of the proposed regulatory 
action. The public should understand that public comments could result 
in changes to elements of the proposed and alternative regulatory 
actions when this rulemaking is finalized. For example, elements such 
as timelines for phase out could be lengthened or shortened, ECELs 
could be modified, or the WCPP could have conditions added or 
eliminated.
    Under the authority of TSCA section 6(g), EPA may consider granting 
a time-limited exemption from a requirement of a TSCA section 6(a) rule 
for a specific condition of use if EPA finds that: (1) The specific 
condition of use is a critical or essential use for which no 
technically and economically feasible safer alternative is available, 
taking into consideration hazard and exposure; (2) Compliance with the 
requirement, as applied with respect to the specific condition of use, 
would significantly disrupt the national economy, national security, or 
critical infrastructure; or (3) The specific condition of use, as 
compared to reasonably available alternatives, provides a substantial 
benefit to health, the environment, or public safety. Based on 
reasonably available information, EPA has analyzed

[[Page 39662]]

the need for an exemption and is proposing that a TSCA section 6(g) 
exemption is warranted for certain conditions of use, as detailed in 
Unit IV.A.5. EPA is requesting comment on the proposed rule's section 
6(g) exemption provisions and rationale. In addition, EPA has found 
that two TSCA section 6(g) exemptions may be warranted if the second 
alternative regulatory action considered by EPA is adopted in the final 
rule. Therefore, the public should assume that if EPA were to 
promulgate the second alternative to the proposed regulatory action, 
EPA would at the same time grant an exemption from the rule 
requirements for two conditions of use under TSCA section 6(g). Unit 
IV.B.2.b. includes information regarding EPA's second alternative 
action that includes exemptions under TSCA section 6(g). EPA is 
requesting public comment regarding the need for exemptions from the 
rule (and under what specific circumstances), including exemptions from 
the proposed regulatory action (e.g., a WCPP) and the primary and 
second alternative regulatory actions, pursuant to the provisions of 
TSCA section 6(g).
    TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating 
TSCA section 6(a) rules, to consider and include a statement addressing 
certain factors, including the costs and benefits and the cost 
effectiveness of the regulatory action and of the one or more primary 
alternative regulatory actions considered by the Administrator. A 
description of all TSCA section 6 requirements considered in developing 
this proposed regulatory action is in Unit III.B.3., and Unit V. 
includes more information regarding EPA's consideration of exemptions 
and alternatives. TSCA section 6(c)(2)(C) requires that in deciding 
whether to prohibit or restrict in a manner that substantially prevents 
a specific condition of use and in setting an appropriate transition 
period for such action, EPA consider, to the extent practicable, 
whether technically and economically feasible alternatives that benefit 
health or the environment will be reasonably available as substitutes 
when the proposed prohibition or restriction takes effect. Unit V.B. 
includes more information regarding EPA's consideration of 
alternatives, and Unit VI. provides more information on EPA's 
considerations more broadly under TSCA section 6(c)(2).
    EPA carried out required consultations as described in this unit 
and also considered impacts on children's environmental health as part 
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
    EPA conducted consultations and outreach in developing this 
proposed regulatory action. The Agency held a federalism consultation 
from July 22, 2021, until October 22, 2021, as part of this rulemaking 
process and pursuant to Executive Order 13132. This included a 
background presentation on September 9, 2020, and a consultation 
meeting on July 22, 2021. During the consultation, EPA met with State 
and local officials early in the process of developing the proposed 
action in order to receive meaningful and timely input into its 
development (Ref. 25). During the consultation, participants and EPA 
discussed additional reporting requirements as a risk management tool 
to address the unreasonable risk, EPA's consideration of safer 
alternatives, and potential impacts to drinking water utilities (Ref. 
25).
    PCE is not manufactured (including imported), processed, 
distributed in commerce, or regulated by Tribal governments. However, 
EPA consulted with Tribal officials during the development of this 
proposed action (Ref. 26). The Agency held a Tribal consultation from 
May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8, 
2021. Tribal officials were given the opportunity to meaningfully 
interact with EPA risk managers concerning the current status of risk 
management. During the consultation, EPA discussed risk management 
under TSCA section 6(a), findings from the 2020 Risk Evaluation for 
PCE, types of information that would be helpful to inform risk 
management, principles for transparency during the risk management 
process, and types of information EPA is seeking from Tribes (Ref. 26). 
EPA received no written comments as part of this consultation.
    In addition to the formal consultations, EPA also conducted 
outreach to advocates of communities that might be subject to 
disproportionate risk from the exposures to PCE, such as minority 
populations, low-income populations, and indigenous peoples. EPA's 
Environmental Justice (EJ) consultation occurred from June 3, 2021, 
through 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 and in compliance with Executive Orders 12898 and 14008. 
EPA received five written comments following the EJ meetings, in 
addition to oral comments provided during the consultation (Refs. 27, 
28, 29, 30, 31). In general, commenters supported strong outreach to 
affected communities, encouraged EPA to follow the hierarchy of 
controls utilized by the industrial hygiene community, favored 
prohibitions, and noted the uncertainty, and in some cases inadequacy, 
of PPE. Commenters also urged EPA to address in this rulemaking ongoing 
releases from hazardous waste and disposal sites, in particular vapor 
intrusion of PCE from contaminated groundwater, soil, and indoor air. 
Additionally, commenters expressed concern that the adverse health 
impacts of PCE dry cleaning fall disproportionately to owners and 
employees of minority owned small businesses, noted the viability of 
professional wet cleaning as an alternative to PCE dry cleaning, and 
urged EPA to consider adverse economic impacts of the regulation and 
establishing a financial program to offset transition costs to local 
communities (Ref. 32).
    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 this proposed rule's 
requirements (Ref. 33). EPA met with SERs before and during Panel 
proceedings, on September 26, 2022, and November 10, 2022. Panel 
recommendations are in Unit X.C. and in the Initial Regulatory 
Flexibility Analysis (IRFA) (Ref. 34), the Panel report is in the 
docket (Ref. 33). EPA requests comment on all elements of the IRFA, 
and, in particular, the flexibilities that EPA has identified following 
input from the SERs during the SBAR process. Additional requests for 
comment based on Panel recommendations are in Unit VIII.
    Units X.C., X.E., X.F., and X.J. provide more information regarding 
the consultations.
2. Other Stakeholder Engagement
    In addition to the formal consultations described in Unit X., EPA 
held a webinar on January 14, 2021, providing an overview of the TSCA 
risk management process and the risk evaluation findings for PCE. EPA 
also presented on the risk evaluation and risk management under TSCA 
for PCE at a Small Business Administration (SBA) Office of Advocacy 
Environmental roundtable on January 15, 2021. At both events, EPA staff 
provided an overview of the TSCA risk management process and the 
findings in the 2020 Risk Evaluation for PCE (Ref. 35). Attendees of 
these meetings were given an opportunity to voice their concerns

[[Page 39663]]

regarding the risk evaluation and risk management.
    Furthermore, EPA engaged in discussions with representatives from 
different industries, non-governmental organizations, technical experts 
and users of PCE. A list of external meetings held during the 
development of this proposed rule is in the docket (Ref. 36); meeting 
materials and summaries are also in the docket. The purpose of these 
discussions was to create awareness and educate stakeholders and 
regulated entities on the provisions for risk management required under 
TSCA section 6(a); explain the risk evaluation findings; obtain input 
from manufacturers, processors, distributors, users, academics, 
advisory councils, and members of the public health community about 
uses of PCE; identify workplace practices, engineering controls, 
administrative controls, PPE, and industrial hygiene plans currently in 
use or feasibly adoptable to reduce exposure to PCE under the 
conditions of use; understand the importance of PCE in the various uses 
subject to this proposed rule; compile knowledge about critical uses, 
substitute chemicals or alternative methods; identify various standards 
and performance specifications; and generate potential risk reduction 
strategies. EPA has met with, or otherwise communicated with, a variety 
of companies, trade associations and non-governmental organizations to 
discuss the topics outlined in this paragraph; a list of external 
meetings held during the development of this proposed rule is in the 
docket (Ref. 36).
3. Children's Environmental Health
    The EPA 2021 Policy on Children's Health (Ref. 37) 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.'' Infants, children, and 
pregnant women are listed as examples of subpopulations that may be 
considered relevant ``potentially exposed or susceptible 
subpopulations'' in the TSCA section 3(12) definition of that term. 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 (including unreasonable risk to PESS).
    The 2020 Risk Evaluation for PCE evaluated the hazards of PCE to 
toddlers and older children (11-15 years and 16-20 years) and did not 
find disproportionate adverse health impacts to these groups (Ref. 1). 
Evidence of hazards to infants and males and females of reproductive 
age was found for reproductive and developmental toxicity. The 
reproductive and developmental health effects of concern related to 
exposures to PCE are reduced sperm quality, spontaneous abortion, and 
decreased fetal/placental weight. The most sensitive non-cancer hazard 
driving the unreasonable risk for PCE is neurotoxicity (CNS effects). 
Early lifestage development of the nervous system can be a sensitive 
period, however the studies on PCE do not provide sufficient evidence 
of greater sensitivity to neurotoxicity in early lifestages than later 
lifestages, such as during adulthood. While the literature contains 
methodological limitations in human studies, animal studies were 
considered adequate to represent reproductive and development effects 
in the 2020 Risk Evaluation for PCE.
    The 2020 Risk Evaluation for PCE released in December 2020 
considered impacts on both children and adults from occupational and 
consumer use from inhalation and dermal exposures, as applicable. For 
occupational use, the risk evaluation considered males (>16 years of 
age) and females of reproductive age (>16 years of age to less than 50 
years of age) for both dermal and inhalation exposures. Additionally, 
because many dry cleaners are family owned and operated, the risk 
evaluation assumed children of employees may spend the full workday at 
dry cleaning facilities, in particular those too young to be in school, 
during which time they may be exposed to similar air concentration 
levels as ONUs. The risk evaluation considered inhalation exposures to 
children of employees present at dry cleaners by evaluating central 
nervous system effects for the most sensitive lifestage: infants less 
than one year old. Children of employees present at dry cleaners would 
be exposed to higher PCE concentrations than children who live or 
attend daycare or school above or adjacent to dry cleaners, and EPA 
therefore expects that risks to those populations are covered by 
evaluation of children within dry cleaning facilities. For consumer 
use, EPA evaluated dermal exposures for children ages 11 to 15 and 16 
to 20 years of age and adults >20 years of age, and the evaluation of 
bystander exposure from inhalation exposures includes infants, toddlers 
and older children. While risks to children are not disproportionate, 
effects observed in studies include central nervous system effects from 
acute inhalation exposure.

B. Regulatory Assessment of PCE

1. Description of Conditions of Use
    This unit describes the TSCA conditions of use that drive EPA's 
unreasonable risk determination for the chemical substance PCE. 
Condition of use descriptions were obtained from EPA sources such as 
CDR use codes, the 2020 Risk Evaluation for PCE and related documents, 
as well as the Organisation for Economic Co-operation and Development 
harmonized use codes and stakeholder engagements. For additional 
description of the conditions of use, including process descriptions 
and worker activities considered in the risk evaluation, see the 
Problem Formulation of the 2020 Risk Evaluation for PCE, the 2020 Risk 
Evaluation for PCE, and supplemental files (Refs. 38, 1, 39). EPA 
acknowledges that some of the terms in this unit may be defined under 
other statutes, however the descriptions here are intended to provide 
clarity to the regulated entities who will implement the provisions of 
this rulemaking under TSCA section 6(a).
a. Manufacturing (Including Import)
    i. Domestic manufacture. This condition of use refers to the making 
or producing of a chemical substance within the United States 
(including manufacturing for export), or the extraction of a component 
chemical substance from a previously existing chemical substance or a 
complex combination of substances. This description does not apply to 
PCE production as a byproduct, including during the manufacture of 1,2-
dichloroethane which EPA intends to consider in the risk evaluation for 
1,2-dichloroethane (Ref. 40).
    ii. Import. This condition of use refers to the act of causing a 
chemical substance or mixture to arrive within the customs territory of 
the United States.
b. Processing
    i. Processing as a reactant/intermediate. This condition of use 
refers to processing PCE in chemical reactions for the manufacturing of

[[Page 39664]]

another chemical substance or product. Through processing as a reactant 
or intermediate, PCE serves as a feedstock in the production of another 
chemical product via a chemical reaction in which PCE is completely 
consumed. For example, PCE is used as a reactant in the production of 
HFCs, hydrochlorofluorocarbons (HCFCs), and chlorofluorocarbons (CFCs). 
This condition of use includes reuse of PCE, including PCE originally 
generated as a byproduct or residual PCE as a reactant.
    ii. Processing into formulation, mixture or reaction product in 
cleaning and degreasing products. This condition of use refers to when 
PCE is added to a cleaning or degreasing product (or product mixture) 
prior to further distribution of the product. For example, formulators 
may mix PCE at varying concentrations with other additives to formulate 
cleaning or degreasing products that are used to remove dirt and 
dissolve oils, greases, and similar materials from textiles, glassware, 
metal surfaces, furniture, furnishings, and other articles, or to 
cleanse, sanitize, bleach, scour, polish, protect, or improve the 
appearance of surfaces.
    iii. Processing into formulation, mixture or reaction product in 
adhesive and sealant products. This condition of use refers to when PCE 
is added to an adhesive or sealant product (or product mixture) prior 
to further distribution of the product. For example, formulators may 
mix PCE at varying concentrations with other additives to formulate 
products that promote bonding between other substances, promote 
adhesion of surfaces, or prevent seepage of moisture or air.
    iv. Processing into formulation, mixture or reaction product in 
paint and coating products. This condition of use refers to when PCE is 
added to a paint or coating product (or product mixture) prior to 
further distribution of the product. For example, formulators may mix 
PCE at varying concentrations with other additives to formulate paint 
and coating products that are applied to surfaces to enhance properties 
such as water repellency, gloss, fade resistance, ease of application, 
or foam prevention. Additionally, PCE is incorporated into coating 
products, such as maskant, that protect a substrate during exposure to 
a chemical process such as chemical milling, plating, and anodizing.
    v. Processing into formulation, mixture or reaction product in 
other chemical products and preparations. This condition of use refers 
to when PCE is added to other chemical products (or product mixtures) 
or preparations prior to further distribution of the product. For 
example, formulators may mix PCE at varying concentrations with other 
additives to formulate inks, toners, colorants, photographic supplies, 
lubricants, greases, mold releases, and other products.
    vi. Processing by repackaging. This condition of use refers to the 
preparation of a chemical substance or mixture for distribution in 
commerce in a different form, state, or quantity. This includes 
transferring of PCE from a bulk container into smaller containers.
    vii. Recycling. This condition of use refers to processing waste 
streams of PCE at a third-party site for the purpose of recovering 
materials or otherwise preparing the waste for reuse instead of 
disposal. Waste solvents can be restored via solvent reclamation/
recycling. The recovery process may involve an initial vapor recovery 
or mechanical separation step followed by distillation, purification, 
and final packaging.
c. Industrial and Commercial Use
    i. Industrial and commercial use as solvent for open-top batch 
vapor degreasing. This condition of use refers to the industrial and 
commercial use of PCE as a solvent for cleaning and degreasing through 
the process of heating PCE to its volatilization point and using its 
vapors to remove dirt, oils, greases, and other surface contaminants 
from metal and other parts using batch open-top vapor degreaser 
machines.
    ii. Industrial and commercial use as solvent for closed-loop batch 
vapor degreasing. This condition of use refers to the industrial and 
commercial use of PCE as a solvent for cleaning and degreasing through 
the process of heating PCE to its volatilization point and using its 
vapors to remove dirt, oils, greases, and other surface contaminants 
from metal and other parts using batch closed-loop degreaser machines.
    iii. Industrial and commercial use as solvent for in-line 
conveyorized vapor degreasing. This condition of use refers to the 
industrial and commercial use of PCE as a solvent for cleaning and 
degreasing through the process of heating PCE to its volatilization 
point and using its vapors to remove dirt, oils, greases, and other 
surface contaminants from metal and other parts using in-line 
conveyorized vapor degreaser machines.
    iv. Industrial and commercial use as solvent for in-line web 
cleaner vapor degreasing. This condition of use refers to the 
industrial and commercial use of PCE as a solvent for cleaning and 
degreasing through a process of heating PCE to its volatilization point 
and using its vapors to remove dirt, oils, greases, and other surface 
contaminants from metal and other parts using web vapor degreaser 
machines.
    v. Industrial and commercial use as solvent for cold cleaning. This 
condition of use refers to the industrial and commercial use of PCE as 
a non-boiling solvent in cold cleaning machines, including simple spray 
sinks and dip tanks, to remove dirt, oils, greases, and other surface 
contaminants from metal and other parts.
    vi. Industrial and commercial use as solvent for aerosol spray 
degreaser/cleaner. This condition of use refers to the industrial and 
commercial use of PCE as a solvent in degreasing and cleaning products 
to remove dirt, grease, stains, spots, and foreign matter through a 
process that uses an aerosolized solvent spray, typically applied from 
a pressurized can, to remove residual contaminants from electronics, 
metals, and other fabricated materials. This description includes use 
of PCE in products for energized electrical cleaning for equipment with 
an electrical current running through it, such as electric motors, 
armatures, relays, electric panel, generators, and other equipment. 
This description does not apply to use of PCE in products intended for 
automotive care, welding, or mold cleaning, which are described in 
different conditions of use.
    vii. Industrial and commercial use as a solvent for aerosol 
lubricants. This condition of use refers to the industrial and 
commercial use of PCE in aerosolized products to reduce friction, heat 
generation and wear between solid surfaces.
    viii. Industrial and commercial use as a solvent for penetrating 
lubricants and cutting tool coolants. This condition of use refers to 
the industrial and commercial use of PCE in liquid products such as 
metalworking, cutting, and tapping fluids, including penetrating 
lubricants and cutting tool coolants, to reduce friction, heat 
generation and wear between solid surfaces.
    ix. Industrial and commercial use in solvent-based adhesives and 
sealants. This condition of use refers to the industrial and commercial 
use of PCE as a solvent in adhesive and sealant products to promote 
bonding between other substances, promote adhesion of surfaces, or 
prevent seepage of moisture or air.
    x. Industrial and commercial use in solvent-based paints and 
coatings. This condition of use refers to the industrial and commercial 
use of PCE as a solvent in paint and coating, including maskant, that 
is applied to surfaces to enhance properties such as water repellence, 
increased gloss, improved fade

[[Page 39665]]

resistance, ease of application, and foam prevention. This description 
does not apply to the use of PCE in maskant for chemical milling, which 
is described in a different condition of use
    xi. Industrial and commercial use in maskant for chemical milling. 
This condition of use refers to the industrial and commercial use of 
PCE as a solvent in maskants or elastomer-based coatings that are used 
to protect a substrate during exposure to a chemical process, such as 
chemical milling, plating and anodizing.
    xii. Industrial and commercial use as a processing aid in 
pesticide, fertilizer and other agricultural chemical manufacturing. 
This condition of use refers to the industrial and commercial use of 
PCE to improve the processing characteristics or the operation of 
process equipment or to alter or buffer the pH of the substance of 
mixture during the production of non-pesticidal products used to 
increase the productivity and quality of plant, animal and forestry 
crops produced on a commercial scale. Processing aids are added to a 
reaction mixture to aid in the manufacture or synthesis or another 
chemical substance but are not intended to remain in or become part of 
the product or product mixture or affect the function of a substance or 
article created.
    xiii. Industrial and commercial use as a processing aid in catalyst 
regeneration in petrochemical manufacturing. This condition of use 
refers to the industrial and commercial use of PCE to improve 
processing characteristics or the operation of process equipment during 
the production of oil, gas, and other similar products. For example, 
PCE is used in both reforming and isomerization processes at 
refineries. In the reforming process, PCE is added directly to a 
regenerator in a Continuous Catalytic Regeneration reforming unit, and 
in the isomerization process, PCE is added to the hydrocarbon feed. In 
both processes, PCE provides chlorine ions to regenerate the catalysts 
and is consumed in the process.
    xiv. Industrial and commercial use in wipe cleaning. This condition 
of use refers to the industrial and commercial use of PCE in non-
aerosol degreasing and cleaning products to remove dirt, grease, 
stains, spots, and foreign matter from furniture and furnishings or to 
cleanse, sanitize, bleach, scour, polish, protect, or improve the 
appearance of surfaces through wipe cleaning.
    xv. Industrial and commercial use in other spot cleaning and spot 
removers, including carpet cleaning. This condition of use refers to 
the industrial and commercial use of PCE in products to remove dirt, 
grease, stains, spots, and foreign matter from furniture and furnishes, 
including carpets and rugs. This description does not apply to the use 
of PCE as a spot cleaner at dry cleaning facilities, which is described 
under other conditions of use.
    xvi. Industrial and commercial use in mold release. This condition 
of use refers to the industrial and commercial use of PCE in products 
to remove dirt, grease, stains, spots, and foreign matter, including 
release agent residues, from molds and casting surfaces.
    xvii. Industrial and commercial use in dry cleaning and spot 
cleaning post-2006 dry cleaning. This condition of use refers to 
industrial and commercial use of PCE in products for spot cleaning and 
as a solvent in degreasing and cleaning applications to remove dirt, 
grease, stains, spots, and foreign matter from garments at dry cleaning 
facilities that use PCE dry cleaning machines after the promulgation of 
the 2006 PCE NESHAP for Dry Cleaning Facilities (40 CFR part 63, 
subpart M). This includes dry cleaning facilities using third 
generation (dry-to-dry, non-vented machines with refrigerated 
condensers), fourth generation (dry-to-dry, non-vented machines with 
both refrigerated condensers and carbon adsorbers as secondary vapor 
controls), or fifth generation (dry-to-dry, non-vented machines with 
secondary vapor controls, a monitor inside the machine drum, and an 
interlocking system to ensure the concentration is below approximately 
300 ppm before the loading door can be opened) PCE dry cleaning 
machines.
    xviii. Industrial and commercial use in dry cleaning and spot 
cleaning 4th/5th gen only dry cleaning. This condition of use refers to 
industrial and commercial use of PCE in products for spot cleaning and 
as a solvent in degreasing and cleaning applications to remove dirt, 
grease, stains, spots, and foreign matter from garments at dry cleaning 
facilities that use fourth generation or fifth generation PCE machines. 
In addition to use as a solvent in dry cleaning equipment, PCE is found 
in products to spot clean garments to remove stains or spots before and 
after dry cleaning treatment.
    xix. Industrial and commercial use in automotive care products 
(e.g., engine degreaser and brake cleaner). This condition of use 
refers to the industrial and commercial use of PCE in aerosolized 
products to remove dirt, grease, stains, and foreign matter from 
interior and exterior vehicle surfaces. This description includes use 
of products for motorized vehicle maintenance and their parts, but does 
not include energized electrical cleaners, which is covered by the 
industrial and commercial use as a solvent for aerosol spray degreaser/
cleaner. Additionally, this description does not include use of non-
aerosolized products intended for automotive care, which are covered by 
different conditions of use.
    xx. Industrial and commercial use in non-aerosol cleaner. This 
condition of use refers to the industrial and commercial use of PCE in 
non-aerosol products to remove dirt, grease, stains, and foreign matter 
from furniture, furnishings, interior or exterior vehicles, and other 
materials, or to clean, sanitize, bleach scour, polish, or improve the 
appearance of surfaces in all other applications not specified 
elsewhere in this section.
    xxi. Industrial and commercial use in metal (e.g., stainless steel) 
and stone polishes. This condition of use refers to the industrial and 
commercial use of PCE in non-aerosolized products for metal (e.g., 
stainless steel) and stone polishing applications, including stone and 
marble cleaner and wax.
    xxii. Industrial and commercial use in laboratory chemicals. This 
condition of use refers to the industrial and commercial use of PCE, 
often in small quantities, in a laboratory process or in specialized 
laboratory equipment for instrument calibration/maintenance chemical 
analysis, chemical synthesis, extracting and purifying other chemicals, 
dissolving other substances, executing research, development, test and 
evaluation methods, and similar activities.
    xxiii. Industrial and commercial use in welding. This condition of 
use refers to the industrial and commercial use of PCE in welding 
applications. For example, PCE can be found in aerosolized products 
that cast or join materials, promote the fusing of minerals, and 
prevent oxide formation, including products that reduce welding spatter 
or prevent the spatter from sticking to surfaces.
    xxiv. Industrial and commercial use in other textile processing. 
This condition of use refers to the industrial and commercial use of 
PCE in processing textile products not described elsewhere. For 
example, PCE is used as a scourer and for sizing and finishing of 
cloth.
    xxv. Industrial and commercial use in wood furniture manufacturing. 
This condition of use refers to the industrial and commercial use of 
PCE in the manufacture of wood furniture or wood furniture components 
(including household furniture, wood office furniture, wood containers 
and pallets,

[[Page 39666]]

and all other wood products) not described elsewhere.
    xxvi. Industrial and commercial use in foundry applications. This 
condition of use refers to the industrial and commercial use of PCE in 
metal foundry, smelting, and metallurgical applications not described 
elsewhere, such as soldering/desoldering, at nonferrous metal foundries 
(except die-casting), nonferrous metal diecasting foundries, aluminum 
foundries, and iron foundries.
    xxvii. Industrial and commercial use in specialty Department of 
Defense uses (oil analysis and water pipe repair). During the risk 
evaluation, the Department of Defense (DOD) provided monitoring data 
for PCE in various uses, including for oil analysis and water pipe 
repair. This condition of use refers to the industrial and commercial 
use of PCE in specialty DOD uses in oil analysis and water pipe repair. 
After the risk evaluation was published, DOD determined there is no 
current data to indicate that PCE is required for these specialty uses.
    xxviii. Commercial use in inks and ink removal products (based on 
printing). This condition of use refers to the commercial use of PCE in 
ink and ink removal products used in printing for writing, printing, or 
creating an image on paper and other substrates, applied to substrates 
to change their color or hide images, or to remove dirt and other 
contaminants from substrates such as cleaning machines or printing 
plates, at print shops.
    xxix. Commercial use in inks and ink removal products (based on 
photocopying). This condition of use refers to the commercial use of 
PCE in ink and ink removal products used in photocopying for writing, 
printing, creating an image on paper and other substrates, applied to 
substrates to change their color or hide images, or to remove dirt and 
other contaminants from substrates such as cleaning machines or 
printing plates.
    xxx. Commercial use in photographic film. This condition of use 
refers to the commercial use of PCE in photographic supplies, film, 
photoprocessing chemicals, and photographic paper. For example, PCE is 
used as a liquid-gate fluid to help protect scratching of optical 
negatives during filming.
    xxxi. Commercial use in metal mold cleaning, release and protectant 
products. This condition of use refers to the commercial use of PCE in 
mold release products to create barriers to prevent certain materials 
from adhering to each other. This description does not apply to the use 
of PCE in mold cleaning products that remove residual coatings from 
mold release, which is described under a different condition of use.
d. Consumer Use
    i. Consumer use in cleaners and degreasers (other). This condition 
of use refers to the consumer use of PCE as a solvent in degreasing and 
cleaning products use to remove dirt, grease, stains, spots, and 
foreign matter through a process that uses an aerosolized solvent 
spray, typically applied from a pressurized can, to remove residual 
contaminants from electronics, metals, and other fabricated materials 
not described elsewhere in this section.
    ii. Consumer use in dry cleaning solvent. This condition of use 
refers to consumer exposure to PCE used to remove dirt, grease, stains, 
spots, and foreign matter from garments via dry cleaning, in particular 
the transportation, storage, and wear of articles that were dry cleaned 
with PCE. For example, garments that are dry cleaned at facilities that 
use PCE as a dry cleaning solvent have residual concentrations of PCE 
remaining in the article after a dry cleaning event.
    iii. Consumer use in automotive care products (brake cleaner). This 
condition of use refers to the consumer use of PCE in aerosolized 
products to remove dirt, grease, stains, and foreign matter from 
interior and exterior vehicle surfaces, including brake cleaner.
    iv. Consumer use in automotive care products (parts cleaner). This 
condition of use refers to the consumer use of PCE in non-aerosolized 
products that are to remove dirt, grease, stains, and foreign matter 
from interior and exterior vehicle surfaces, including parts cleaner.
    v. Consumer use in aerosol cleaner (vandalism mark and stain 
remover). This condition of use refers to the consumer use of PCE in 
aerosolized products for cleaning and furniture care, including 
vandalism mark and stain remover.
    vi. Consumer use in non-aerosol cleaner (e.g., marble and stone 
polish). This condition of use refers to the consumer use of PCE in 
non-aerosolized products for cleaning and furniture care, typically in 
the form of a solid or liquid cleaner not described elsewhere in this 
section, including liquid marble and stone polish.
    vii. Consumer use in lubricants and greases (cutting fluid). This 
condition of use refers to the consumer use of PCE in non-aerosolized 
products to reduce friction, heat generation and wear between solid 
surfaces, including cutting fluid.
    viii. Consumer use in lubricants and greases (lubricants and 
penetrating oils). This condition of use refers to the consumer use of 
PCE in aerosolized products to reduce friction, heat generation and 
wear between solid surfaces, including lubricant and penetrating oils.
    ix. Consumer use in adhesives for arts and crafts (including 
industrial adhesive, arts and crafts adhesive, gun ammunition sealant). 
This condition of use refers to the consumer use of PCE as an adhesive 
in arts, crafts, and hobby products to promote bonding between other 
substances, promote adhesion of surfaces, or prevent seepage of 
moisture or air, in particular industrial adhesive, adhesive for arts 
and crafts, and gun ammunition sealant. For example, PCE may be used in 
gun ammunition sealant products to ensure no moisture gets into 
ammunition casings.
    x. Consumer use in adhesives for arts and crafts (livestock 
grooming adhesive). This condition of use refers to the consumer use of 
PCE in livestock grooming adhesive spray.
    xi. Consumer use in adhesives for arts and crafts (column adhesive, 
caulk and sealant). This condition of use refers to the consumer use of 
PCE for column adhesive, caulk and sealant.
    xii. Consumer use in solvent-based paints and coatings (outdoor 
water shield (liquid)). This condition of use refers to the consumer 
use of PCE in solvent-based non-aerosol paint and coating products to 
enhance properties such as water repellence, increased gloss, improved 
fade resistance, ease of application, or foam prevention, in particular 
the use in outdoor water shield sealants and coatings.
    xiii. Consumer use in solvent-based paints and coatings (coating 
and primers (aerosol)). This condition of use refers to the consumer 
use of PCE in solvent-based paint and coating aerosol products to 
enhance properties such as water repellence, increased gloss, improved 
fade resistance, ease of application, or foam prevention, in particular 
the use in aerosolized coating and primers.
    xiv. Consumer use in solvent-based paints and coatings (rust primer 
and sealant (liquid)). This condition of use refers to the consumer use 
of PCE in solvent-based paint and coating liquid products to enhance 
properties such as water repellence, increased gloss, improved fade 
resistance, ease of application, or foam prevention, in particular the 
use in liquid rust primer and sealant.
    xv. Consumer use in solvent-based paints and coatings (metallic 
overglaze). This condition of use refers to the consumer use of PCE in 
solvent-based paint and coating products to enhance

[[Page 39667]]

properties such as water repellence, increased gloss, improved fade 
resistance, ease of application, or foam prevention, in particular the 
use in solvent based metallic overglaze for ceramics.
    xvi. Consumer use in metal (e.g., stainless steel) and stone 
polishes. This condition of use refers to the consumer use of PCE in 
liquid wax-based products for metal (e.g., stainless steel) and stone 
polishing.
    xvii. Consumer use in inks and ink removal products. This condition 
of use refers to the consumer use of PCE in ink and ink removal 
products for writing, printing, creating an image on paper and other 
substrates, applied to substrates to change their color or hide images, 
or to remove dirt and other contaminants from substrates.
    xviii. Consumer use in welding. This condition of use refers to the 
consumer use of PCE in products that cast or join materials, promote 
the fusing of minerals, or prevent oxide formation, including products 
that reduce welding spatter or prevent the spatter from sticking to 
surfaces.
    xix. Consumer use in metal mold cleaning, release and protectant 
products. This condition of use refers to the consumer use of PCE in 
products to create barriers to prevent certain materials from adhering 
to each other and assist in the removal of dirt, grease, oils, and 
other contaminants from metal molds, machinery, electrical and 
electronic equipment, pins, and mechanical equipment.
e. Disposal
    This condition of use refers to the process of disposing generated 
waste streams of PCE that are collected and transported to a third-
party site for their final disposition, such as waste incineration or 
landfilling.
f. Terminology in This Proposed Rule
    For purposes of this proposed rulemaking ``occupational conditions 
of use'' refers to the TSCA conditions of use described in Units 
III.B.1.a., b., c., and e. Although EPA identified both industrial and 
commercial uses in the 2020 Risk Evaluation for PCE 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, in the 2020 Risk Evaluation for the chemical 
substance PCE, EPA identified and assessed all known, intended, and 
reasonably foreseen industrial, commercial, and consumer uses of PCE in 
order to determine whether PCE as a whole chemical substance presents 
unreasonable risks to health and the environment. EPA determined that 
all industrial, commercial, and consumer uses of PCE evaluated in the 
2020 Risk Evaluation for PCE drive the EPA determination that PCE 
presents unreasonable risk of injury to health. As such, for purposes 
of this risk management rulemaking, ``consumer use'' refers to all 
consumer uses including known, intended, and reasonably foreseen 
consumer uses of PCE. Likewise, for the purpose of this risk management 
rulemaking, ``industrial and commercial use'' refers to all industrial 
and commercial uses, including known, intended, or reasonably foreseen 
PCE industrial and commercial use.
    EPA is not proposing to incorporate the descriptions of known, 
intended or reasonably foreseen conditions of use in Unit III.B.1.a 
through e into the regulatory text as definitions because these 
conditions of use represent those evaluated in the 2020 Risk Evaluation 
for PCE whereas the regulatory text applies to all TSCA consumer and 
industrial/commercial uses. EPA requests comment on whether EPA should 
promulgate definitions for those conditions of use evaluated in the 
2020 Risk Evaluation for PCE that would not be prohibited, and, if so, 
whether the descriptions in this unit are consistent with the 
conditions of use evaluated in the 2020 Risk Evaluation for PCE and 
whether they provide a sufficient level of detail to improve the 
clarity and readability of the regulation if EPA were to promulgate a 
regulation that contains a list of the industrial and commercial 
conditions of use evaluated in the 2020 Risk Evaluation for PCE.
    EPA further notes that this proposed 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 (FFDCA), when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic or device.
2. Description of Unreasonable Risk Under the Conditions of Use
    EPA has determined that PCE presents an unreasonable risk of injury 
to human health under the conditions of use based on acute and chronic 
non-cancer risks and chronic cancer risks (Ref. 2). As described in the 
TSCA section 6(b) 2020 Risk Evaluation for PCE, EPA identified non-
cancer adverse effects from 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). Additional risks 
associated with other adverse effects (e.g., kidney, liver, immune 
system, and developmental toxicity) were identified for acute and 
chronic exposures. EPA also concluded, based on EPA's Guidelines for 
Carcinogen Risk Assessment (Ref. 41), that PCE is likely to be 
carcinogenic to humans by all routes of exposure and calculated cancer 
risks from chronic inhalation and dermal exposures. Unit VI.A. 
summarizes the health effects and the magnitude of exposures (Ref. 1).
    To make the unreasonable risk determination for PCE, EPA evaluated 
exposures to workers, ONUs, children of workers at dry cleaners, 
consumer users, and bystanders to consumer use using reasonably 
available monitoring and modeling data for inhalation and dermal 
exposures (Ref. 2). EPA conducted a screening level analysis to assess 
potential risks from the air and water pathways to fenceline 
communities. A discussion of EPA's analysis and the expected effects of 
this rulemaking on fenceline communities is in Unit VI.A.
    For the 2020 Risk Evaluation for PCE, EPA considered PESS. EPA 
identified the following groups as PESS: workers, ONUs, children of 
workers at dry cleaners, consumers, bystanders, developing fetuses (and 
by extension, women of childbearing age), and those with certain pre-
existing health conditions, higher body fat content, or particular 
genetic polymorphisms (Ref. 1). All PESS are included in the 
quantitative and qualitative analyses described in the risk evaluation, 
and were considered in the determination of unreasonable risk for PCE. 
As discussed in Unit II.D. and Unit VI.A., the 2020 Risk Evaluation for 
PCE excluded the air and water exposure pathways to the general 
population from the published

[[Page 39668]]

risk evaluations and may have caused some risks to be unaccounted for 
in the risk evaluation. EPA considers these receptors a subset of the 
general population and categorizes them as fenceline communities; they 
may also be considered PESS. See Unit VI.A. for further discussion on 
assessing and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
    EPA examined the TSCA section 6(a) requirements (listed in Unit 
III.A.) to identify which ones have the potential to eliminate the 
unreasonable risk for PCE. This Unit summarizes the TSCA section 6 
considerations for issuing regulations under TSCA section 6(a). Unit V. 
outlines how EPA applied these considerations specifically to managing 
the unreasonable risk from PCE.
    As required, EPA developed a proposed regulatory action and one or 
more primary alternative regulatory actions, which are described in 
Units IV.A. and IV.B., respectively. 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 (see Unit III.B.1.f.), 
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 does 
not have direct authority to regulate consumer use. Therefore, EPA 
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 points 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 identified unreasonable risk, when selecting 
among possible TSCA section 6(a) requirements. To the extent 
practicable, EPA factored into its decisions: (i) The effects of PCE on 
health and the environment; (ii) The magnitude of exposure to PCE of 
human beings and the environment; (iii) The benefits of PCE for various 
uses; and (iv) The reasonably ascertainable economic consequences of 
the rule. In evaluating the reasonably ascertainable economic 
consequences of the rule, EPA considered: (i) The likely effect of the 
rule on the national economy, small business, technological innovation, 
the environment, and public health; (ii) The costs and benefits of the 
proposed regulatory action and one or more primary alternative 
regulatory actions considered; and (iii) The cost effectiveness of the 
proposed regulatory action and of the one or more primary alternative 
regulatory actions considered. See Unit VI. for further discussion 
related to TSCA section 6(c)(2)(A) considerations, including the 
statement of effects of the proposed rule with respect to these 
considerations.
    EPA also considered the regulatory authority under TSCA and other 
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and 
other EPA-administered statutes to examine: (1) Whether there are 
opportunities for all or part of risk management action on PCE to be 
addressed under other statutes, such that a referral may be warranted 
under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a) 
regulation could include alignment of requirements and definitions in 
and under existing statutes to minimize confusion to the regulated 
entities and the general public.
    In addition, EPA followed other TSCA requirements such as 
considering the availability of alternatives when contemplating 
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as 
outlined in Unit V.B.), and setting proposed compliance dates in 
accordance with the requirements in TSCA section 6(d)(1) (described in 
the proposed and alternative regulatory actions in Unit IV.).
    To the extent information was reasonably available, when selecting 
regulatory actions, EPA considered pollution prevention and the 
hierarchy of controls adopted by OSHA and NIOSH, with the goal of 
identifying risk management control methods that are permanent, 
feasible, and effective. EPA also considered how to address the 
unreasonable risk while providing flexibility to the regulated entities 
where appropriate. EPA considered the information presented in the 2020 
Risk Evaluation for PCE, as well as additional input from stakeholders 
(as described in Unit III.A.), and anticipated compliance strategies 
from regulated entities.
    Taken together, these considerations led EPA to the proposed 
regulatory action and primary alternative regulatory actions described 
in Unit IV. Additional details related to how the requirements in this 
unit were incorporated into development of those actions are in Unit V.
    As demonstrated by the number of distinct programs addressed in 
this rulemaking and the structure of this proposed rule in addressing 
them independently, EPA generally intends the rule's provisions to be 
severable from each other. EPA expects to provide additional detail on 
severability in the final rule once the Agency has considered public 
comments and finalized the regulatory language.

IV. Proposed and Alternative Regulatory Actions

    This unit describes the proposed regulatory action by EPA so that 
PCE will no longer present an unreasonable risk of injury to health. In 
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider 
the costs and benefits and the cost-effectiveness of the proposed 
regulatory action and one or more primary alternative regulatory 
actions. In the case of PCE, the proposed regulatory action is 
described in Unit IV.A. and the two alternative regulatory actions 
considered are described in Unit IV.B. An overview of the proposed 
regulatory action and two alternative regulatory actions for each 
condition of use is in Unit IV.C. The rationale for the proposed and 
alternative regulatory actions and associated compliance timeframes are 
discussed in this unit and in more detail in Unit V.A.

A. Proposed Regulatory Action

    EPA is proposing under TSCA section 6(a) to: 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.A.1.a.; Prohibit the manufacture (including 
import), processing, and distribution in commerce of PCE for all 
consumer use, outlined in Unit IV.A.1.b.; 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.A.1.c.; Require 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 16 occupational conditions of use not 
prohibited, outlined in Unit IV.A.2.; Require prescriptive workplace 
controls for laboratory use, outlined in Unit IV.A.3.; Establish 
recordkeeping and downstream notification requirements, outlined in 
Unit IV.A.4; and Provide a 10-year time limited exemption under TSCA 
section 6(g) for certain critical or essential emergency uses of PCE 
for which no technically and economically feasible safer alternative is 
available, outlined in Unit IV.A.5. As the manufacture and processing 
of PCE presents an unreasonable risk to health in the

[[Page 39669]]

United States, the manufacture and processing of PCE for export would 
also be prohibited or restricted in accordance with TSCA section 
12(a)(2).
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce, 
and Use
a. Prohibition of Certain Industrial and Commercial Uses and 
Manufacturing, Processing, and Distribution in Commerce of PCE for 
Those Uses
    EPA is proposing to prohibit the manufacturing, processing, 
distribution in commerce, and use of PCE for industrial and commercial 
uses, except for those uses which would continue under the WCPP (as 
described in Unit IV.A.2.), and laboratory use (as described in Unit 
IV.A.3.). The proposed prohibitions under TSCA would not apply to any 
use of PCE that is excluded from TSCA's definition of ``chemical 
substance'' under TSCA section 3(2)(B)(ii) through (vi). This proposed 
prohibition would include a prohibition on the manufacturing, 
processing, distribution in commerce, and use of PCE for the following 
industrial and commercial uses:
     As a processing aid in pesticide, fertilizer and other 
agricultural chemical manufacturing;
     In specialty DOD uses (oil analysis and water pipe 
repair);
     In solvent-based paints and coatings;
     As solvent for aerosol spray degreaser/cleaner;
     As solvent for cold cleaning;
     In other textile processing;
     In wood furniture manufacturing;
     As a solvent for aerosol lubricants;
     In wipe cleaning;
     In other spot cleaning and spot removers, including carpet 
cleaning;
     In automotive care products (e.g., engine degreaser and 
brake cleaner);
     In non-aerosol cleaner;
     In metal (e.g., stainless steel) and stone polishes;
     In foundry applications;
     In welding;
     For mold release;
     As a solvent for penetrating lubricants and cutting tool 
coolants;
     For photographic film;
     In inks and ink removal products (based on printing);
     In inks and ink removal products (based on photocopying); 
and
     In metal mold cleaning, release and protectant products.
    EPA is also proposing to prohibit the following condition of use, 
which is the upstream processing condition of use for some of the 
prohibited industrial and commercial uses: processing into formulation, 
mixture or reaction product in other chemical products and 
preparations. EPA is also proposing to phase out the use of PCE at 
industrial and commercial dry cleaning facilities as described in Unit 
IV.A.1.c.
    EPA has considered the sensitive nature of the DOD applications for 
which EPA received monitoring data for the 2020 Risk Evaluation for 
PCE, including for the industrial and commercial use in specialty DOD 
uses (oil analysis and water pipe repair). The Agency understands that 
DOD has no current data that indicate PCE is required for these 
specialty uses and EPA has not identified any other entities using PCE 
in this way. Because there are no known entities engaged in this 
condition of use, EPA believes a prohibition is reasonable and would 
prevent any future entities from engaging in this use. EPA is therefore 
proposing to prohibit the manufacturing, processing, distribution in 
commerce, and use of PCE for the industrial and commercial use in 
specialty DOD uses (oil analysis and water pipe repair).
    As discussed in Units III.B.3. and V.A., based on consideration of 
alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the 
feasibility of exposure reduction to sufficiently address the 
unreasonable risk across the broad range of work environments and 
activities, and the irreversible health effects associated with PCE 
exposures, EPA has determined that prohibition is the best way to 
address the unreasonable risk from PCE driven in part by the conditions 
of use identified in this unit. As noted in Unit III.B.1.f., this 
proposal does not apply to any substance excluded from the definition 
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi). 
EPA requests comment on the impacts, if any, a prohibition on the 
processing of PCE into a formulation, mixture or reaction product in 
other chemical products and preparations, or other aspects of this 
proposal, may have on the production and availability of any pesticide 
or other substance excluded from the TSCA definition of ``chemical 
substance.''
    EPA is proposing to stagger the compliance dates for the proposed 
prohibitions described in this unit, such that the requirements would 
come into effect in 12 months for manufacturers, 15 months for 
processers, 18 months for distributing to retailers, 21 months for all 
other distributors (including retailers), and 24 months for industrial 
and commercial users after the publication date of the final rule. When 
proposing these compliance dates as required under TSCA section 6(d), 
EPA considered irreversible health effects and risks associated with 
PCE exposure. EPA has no reasonably available information indicating 
that the proposed compliance dates are not practicable for the 
activities that would be prohibited, or that additional time is needed 
for products to clear the channels of trade. However, EPA requests 
comment on whether additional time is needed, for example, for products 
to clear the channels of trade, or for implementing the use of 
substitutes; comments should include documentation such as the specific 
use of the chemical throughout the supply chain; concrete steps taken 
to identify, test, and qualify substitutes for those uses (including 
details on the substitutes tested and the specific certifications that 
would require updating); and estimates of the time required to 
identify, test, and qualify substitutes with supporting documentation. 
EPA also requests comment on whether these are the appropriate types of 
information for use in evaluating compliance requirements, and whether 
there are other considerations that should apply. EPA may finalize 
significantly shorter or longer compliance timeframes based on 
consideration of public comments.
    Additionally, EPA recognizes that there may be instances where an 
ongoing use of PCE that has implications for national security or 
critical infrastructure as it relates to other Federal agencies (e.g., 
DOD, NASA) is identified after the PCE rule is finalized, but the final 
rule prohibits that use. For instances like that, EPA requests comments 
on an appropriate, predictable, process that could expedite 
reconsideration for uses that Federal agencies or their contractors 
become aware of after the final rule is issued using the tools 
available under TSCA, aligning with the requirements of section 6(g). 
One example of an approach could be the establishment by rulemaking of 
a Federal agency category of use that would require implementation of 
the WCPP and periodic reporting to EPA on details of the use as well as 
progress in discontinuing the use or finding a suitable alternative. To 
utilize the category of use a Federal agency would petition EPA, 
supported by documentation describing the specific use (including 
documentation of the specific need, service life of any relevant 
equipment, and specific identification of any applicable regulatory 
requirements or

[[Page 39670]]

certifications, as well as the location and quantity of the chemical 
being used); the implications of cessation of this use for national 
security or critical infrastructure (including how the specific use 
would prevent injuries/fatalities or otherwise provide life-supporting 
functions); exposure control plan; and, for Federal agency uses where 
similar adoption by the commercial sector may be likely, concrete steps 
taken to identify, test, and qualify substitutes for the uses 
(including details on the substitutes tested and the specific 
certifications that would require updating; and estimates of the time 
required to identify, test, and qualify substitutes with supporting 
documentation). EPA requests comment on whether these are the 
appropriate types of information for use in evaluating this type of 
category of use, and whether there are other considerations that should 
apply. EPA would make a decision on the petition within 30 days and 
publish the decision in the Federal Register shortly after. 
Additionally, during the year following the petition, EPA would take 
public comment on the approved petition and no later than 180 days 
after submitting the petition to EPA, the requesting agency would 
submit monitoring data indicating compliance with the WCPP at each 
relevant location as well as documentation of efforts to identify or 
qualify substitutes. In the absence of that confirmatory data, the 
utilization of the generic Federal agency category of use would expire 
within one year of the date of receipt by EPA of the petition. EPA 
could undertake a section 6(g) rulemaking for those instances where the 
Federal agency could not demonstrate compliance with the WCPP. This is 
just one example of a potential process. EPA requests comments on a 
process that could expedite reconsideration for uses that Federal 
agencies or their contractors become aware of after the final rule is 
issued.
b. Prohibition of Manufacturing, Processing and Distribution in 
Commerce of PCE for Consumer Use
    In the 2020 Risk Evaluation for PCE, EPA evaluated consumer use of 
PCE:
     In cleaners and degreasers (other);
     In automotive care products (brake cleaner);
     In automotive care products (parts cleaner);
     In aerosol cleaner (vandalism mark and stain remover);
     In non-aerosol cleaner (e.g., marble and stone polish);
     In lubricants and greases (cutting fluid);
     In lubricants and greases (lubricants and penetrating 
oils);
     In adhesives for arts and crafts (including industrial 
adhesive, arts and crafts adhesive, gun ammunition sealant);
     In adhesives for arts and crafts (livestock grooming 
adhesive);
     In adhesives for arts and crafts (column adhesive, caulk 
and sealant);
     In solvent-based paints and coatings (outdoor water shield 
(liquid));
     In solvent-based paints and coatings (coatings and primers 
(aerosol));
     In solvent-based paints and coatings (rust primer and 
sealant (liquid));
     In solvent-based paints and coatings (metallic overglaze);
     In metal (e.g., stainless steel) and stone polishes;
     In inks and ink removal products;
     In welding; and
     In metal mold cleaning, release and protectant products.
    The consumer uses evaluated in the 2020 Risk Evaluation for PCE 
constitute all known, intended, and reasonably foreseen consumer uses 
of PCE. EPA determined that all of these consumer uses drive 
unreasonable risk of injury to health. As such, for purposes of this 
risk management rulemaking, ``consumer use'' refers to all consumer 
uses, including all known, intended, and reasonably foreseen consumer 
uses of PCE. EPA is proposing to prohibit the manufacturing, 
processing, and distribution in commerce of PCE for all consumer use. 
EPA is proposing to phase out consumer use in dry cleaning solvent 
(i.e., exposure to clothing or articles recently dry cleaned with PCE 
as described in Unit III.B.1.d.ii.) by phasing out the use of PCE at 
industrial and commercial dry cleaning facilities as described in Unit 
IV.A.1.c.; thus, consumer use of clothing and articles that have been 
commercially dry cleaned with PCE would not be subject to the 
prohibitions and compliance timeframes described in this unit.
    As discussed in Units III.B.3. and V.A., based on consideration of 
the severity of the hazards of PCE in conjunction with the limited 
options available to adequately address the identified unreasonable 
risk to consumers and bystanders under TSCA section 6(a), EPA is 
proposing to address the unreasonable risk from consumer use by 
prohibiting the manufacturing (including import), processing, and 
distribution in commerce of PCE for consumer use in order to remove PCE 
and products containing PCE from the market, thereby effectively 
eliminating instances of consumer use.
    Additionally, EPA is proposing to prohibit retailers from 
distributing in commerce PCE, including any PCE-containing products, in 
order to prevent products intended for industrial and commercial use 
under the WCPP outlined in Unit IV.A.2. from being purchased by 
consumers. A retailer is any person or business entity that distributes 
or makes available products to consumers, including through e-commerce 
internet sales or distribution. If a person or business entity 
distributes or makes available any product to at least one consumer, 
then it is considered a retailer (as EPA proposes to define that term 
in 40 CFR 751.5). For a distributor not to be considered a retailer, 
the distributor must distribute or make available chemical substances 
solely to commercial or industrial end-users or businesses. Prohibiting 
manufacturers (including importers), processors, and distributors from 
distributing PCE, or any products containing PCE, to retailers would 
prevent retailers from making these products available to consumers, 
which would help address that part of the unreasonable risk driven by 
consumer use of PCE.
    EPA is proposing that the prohibition described in this unit would 
take effect in 12 months for manufacturers, 15 months for processers, 
18 months for distributing to retailers, and 21 months for all other 
distributors (including retailers) after the publication date of the 
final rule in the Federal Register. EPA considered irreversible health 
effects and risks associated with PCE exposure when proposing 
compliance dates. EPA has no reasonably available information 
indicating these proposed compliance dates are not practicable for the 
activities that would be prohibited, or that additional time is needed 
for products to clear the channels of trade. However, EPA requests 
comment on whether additional time is needed, for example, for products 
to clear the channels of trade. EPA may finalize significantly shorter 
or longer compliance timeframes based on consideration of public 
comments.
c. Prohibition and Phaseout of PCE in Dry Cleaning
    EPA is proposing to prohibit the manufacturing, processing, 
distribution in commerce, and industrial and commercial use of PCE for 
dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry 
machines with refrigerated condenser) and 4th/5th generation (dry-to-
dry machines with refrigerated condenser and carbon adsorber process 
controls) machines.

[[Page 39671]]

    As discussed in Units III.B.3. and V.A., based on a consideration 
of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to 
the feasibility of exposure reduction to sufficiently address the 
unreasonable risk across the broad range of work environments and 
activities, and the irreversible health effects associated with PCE 
exposures, EPA has determined that prohibition is the best way to 
address the unreasonable risk. A prohibition on the manufacturing, 
processing, distribution in commerce, and industrial and commercial use 
of PCE in dry cleaning and spot cleaning would address the unreasonable 
risk for the following conditions of use evaluated in the 2020 Risk 
Evaluation and described further in Unit III.B.1:
     Industrial and commercial use in dry cleaning and spot 
cleaning post-2006 dry cleaning;
     Industrial and commercial use in dry cleaning and spot 
cleaning 4th/5th generation only dry cleaning; and
     Consumer use in dry cleaning solvent (i.e., exposure to 
clothing or articles recently dry cleaned with PCE).
    EPA recognizes that the transition to an alternative dry cleaning 
process or solvent could require significant time and investment from 
dry cleaning facilities; therefore, EPA is proposing a phaseout period 
to take place following the publication date of the final rule. The 
phaseout would start with a prohibition on the use of PCE in any dry 
cleaning machine acquired 6 months or later after the publication date 
of the rule, followed by a prohibition on the use of PCE in 3rd 
generation machines 3 years after the publication date of the rule. 
Full implementation of the phaseout would be achieved with a 
prohibition on the use of PCE in all dry cleaning and spot cleaning, 
including in 4th and 5th generation machines, 10 years after the 
publication date of the final rule and a prohibition on the 
manufacturing, processing, and distribution in commerce of PCE for use 
in dry cleaning solvent 10 years after the publication date of the 
final rule. When proposing these compliance dates, EPA considered 
reasonably available information, including market research, existing 
State actions restricting the use of PCE in dry cleaning (Title 17, 
California Code of Regulations 39109 and 93110; Minnesota HF 91; 6 
NYCRR Part 232), and engagement with industry, trade associations, and 
State and local agencies. Based on this reasonably available 
information, EPA understands that the use of PCE in dry cleaning is 
currently declining and that very few PCE machines are being produced 
or sold in the U.S. market (Ref. 33). As described more fully in the 
Economic Analysis (Ref. 3), EPA assumes dry cleaning machines are 
retired 15 to 25 years after the manufactured date. Therefore, EPA 
assumes most dry cleaning machines manufactured and installed before 
2005, such as for 3rd generation machines, would be beyond their 
projected useful life by the proposed phaseout dates outlined in this 
Unit. A 3-year phaseout of the use of PCE in 3rd generation dry 
cleaning machines takes into consideration the age of existing 3rd 
generation dry cleaning machines as well as public comments submitted 
on the proposed amendments to the PCE Dry Cleaning NESHAP (December 27, 
2021, 86 FR 73207) recommending a 3- to 5-year compliance timeframe at 
minimum to account for supply issues related to those machines. A 10-
year phaseout of the use of PCE in dry cleaning and spot cleaning takes 
into account that, while the average projected useful lifespan of dry 
cleaning machines is 15 to 25 years, the purchase of new PCE dry 
cleaning machines has been in decline. As described more fully in the 
Economic Analysis, EPA estimates that 6,000 dry cleaners still use PCE 
and estimates that about 60 machines are expected to still be in use at 
the end of the 10-year phaseout period given the declining trend of use 
and age of machines. EPA believes that the proposed 6-month and 3-year 
compliance dates for the start of the phaseout, and the proposed 10-
year compliance date for full implementation of the phaseout, are 
consistent with requirements in TSCA section 6(d)(1)(C) and (D), 
respectively, to specify mandatory compliance dates for the start of 
phaseout requirements that are as soon as practicable but not later 
than 5 years after the date of promulgation of the rule, and to specify 
mandatory compliance dates for full implementation of phaseout 
requirements that are as soon as practicable. EPA also believes that 
these compliance dates provide for a reasonable transition period, 
consistent with TSCA section 6(d)(1)(E). EPA has no reasonably 
available information indicating that the proposed compliance dates are 
not practicable for the activities that would be prohibited. However, 
EPA requests comment on the amount of time needed, for example, for dry 
cleaners to transition to an alternative process or solvent. EPA also 
requests comment regarding the number of entities that could 
potentially close as well as associated costs with a 10-year phaseout 
of PCE for use in dry cleaning as identified in this unit. EPA may 
finalize significantly shorter or longer compliance timeframes based on 
consideration of public comments.
d. De Minimis Level
    To aid the regulated community with implementing the prohibitions, 
and to account for de minimis levels of PCE as an impurity in products, 
EPA is proposing that products containing PCE at concentrations less 
than 0.1% by weight are not subject to the prohibitions described in 
this unit. EPA has determined that the prohibitions are only necessary 
for products containing PCE at levels equal to or greater than 0.1% by 
weight in order to eliminate the unreasonable risk of injury resulting 
from inhalation and dermal exposures from PCE-containing products 
during occupational and consumer conditions of use. EPA's description 
for how allowing for a concentration of PCE up to 0.1% would address 
the unreasonable risk associated with PCE-containing products and 
rationale for this regulatory approach are in Unit V.A. EPA requests 
comment on allowing this de minimis level of PCE in products to account 
for impurities.
2. Workplace Chemical Protection Program (WCPP)
a. Overview
    As described in Unit III.B.3., under TSCA section 6(a), EPA is 
required to issue a regulation applying one or more of the TSCA section 
6(a) requirements to the extent necessary so that the unreasonable risk 
of injury to health or the environment from a chemical substance is no 
longer presented. The TSCA section 6(a) requirements provide EPA the 
authority to limit or restrict a number of activities, alone or in 
combination, including the manufacture, processing, distribution in 
commerce, commercial use, and disposal of the chemical substance. Given 
this authority, EPA may find it appropriate in certain circumstances to 
propose requirements under a WCPP for certain occupational (i.e., 
manufacturing, processing, industrial and commercial use, and disposal) 
conditions of use. A WCPP for PCE would encompass the inhalation 
exposure limit and action level, Direct Dermal Contact Control (DDCC) 
requirements, and the associated implementation requirements described 
in this unit to ensure that the chemical substance no longer presents 
unreasonable risk. Under a WCPP, owners or operators would have some 
flexibility, within the parameters outlined in this unit, regarding how 
they prevent exceedances of the

[[Page 39672]]

identified EPA exposure limit thresholds or prevent direct dermal 
contact. In the case of PCE, meeting the EPA exposure limits and 
implementing the DDCC requirements for certain occupational conditions 
of use would address unreasonable risk to potentially exposed persons 
from inhalation and dermal exposure.
    EPA uses the term ``potentially exposed person'' in this unit and 
in the regulatory text to include workers, ONUs, employees, independent 
contractors, employers and all other persons in the work area where PCE 
is present and who may be exposed to PCE under the conditions of use 
for which a WCPP would apply. EPA's intention is to require a 
comprehensive WCPP that would address the unreasonable risk from PCE to 
potentially exposed persons directly handling the chemical or in the 
area where the chemical is being used.
    Similarly, the 2020 risk evaluation for PCE did not distinguish 
between employers, contractors, or other legal entities or businesses 
that manufacture, process, distribute in commerce, use, or dispose of 
PCE. EPA uses the term ``owner or operator'' to describe the entity 
responsible for implementing the WCPP for workplaces where an 
applicable condition of use is occurring and PCE is present. The term 
includes any person who owns, leases, operates, controls, or supervises 
such a workplace.
    An ECEL is a risk-based inhalation exposure threshold. The ECEL 
would be accompanied by monitoring, training, recordkeeping and other 
requirements to help ensure that the threshold is not exceeded. With an 
ECEL, regulated entities have some flexibility, within certain 
parameters outlined in this unit, for preventing exceedances of the 
identified exposure threshold. Therefore, EPA generally refers to the 
ECEL and ancillary requirements as a non-prescriptive approach. In the 
case of PCE, the exposure threshold identified by EPA for certain 
occupational conditions of use would mitigate unreasonable risk from 
inhalation exposure driven by those conditions of use for potentially 
exposed persons.
    DDCC requirements are process-based approaches to prevent direct 
dermal contact with PCE and associated implementation requirements 
described in this unit to ensure that the chemical substance no longer 
presents unreasonable risk from dermal exposure. As with the ECEL, DDCC 
requirements allow regulated entities some flexibility within certain 
parameters outlined in this unit for preventing direct dermal contact 
with PCE. In the case of PCE, EPA has preliminarily determined that 
preventing direct dermal contact through DDCC requirements for certain 
conditions of use would mitigate unreasonable risk from dermal exposure 
driven by those conditions of use for potentially exposed persons.
    This unit includes a summary of the proposed PCE WCPP, including a 
description of the ECEL; proposed implementation requirements and an 
EPA ECEL action level; proposed monitoring requirements; a description 
of potential exposure controls, which consider the hierarchy of 
controls; information that may be used to inform respirator selection; 
and additional requirements proposed for recordkeeping, and worker 
training, participation, and notification. This unit also describes 
proposed DDCC requirements for PCE, including potential exposure 
controls, which consider the hierarchy of controls; proposed PPE as it 
relates to dermal protection; and additional requirements proposed for 
recordkeeping. This unit also describes compliance timeframes for these 
proposed requirements.
b. Existing Chemical Exposure Limit (ECEL)
    i. ECEL and ECEL action level. To reduce exposures in the workplace 
and address the unreasonable risk of injury to health resulting from 
inhalation exposures to PCE identified under the occupational 
conditions of use in the TSCA 2020 Risk Evaluation for PCE, EPA is 
proposing an ECEL of 0.14 parts per million (ppm) (0.98 mg/m3) for 
inhalation exposures to PCE as an 8-hour TWA. This ECEL is based on the 
occupational chronic, non-cancer human equivalent concentration (HEC) 
for neurotoxicity (Ref. 10). EPA has determined, as a matter of risk 
management policy, that ensuring exposures remain at or below the ECEL 
would eliminate the contribution to the unreasonable risk of injury to 
health for PCE resulting from inhalation exposures in an occupational 
setting. EPA is proposing to establish requirements to meet an ECEL as 
part of the WCPP for:
     Manufacturing (domestic manufacturing);
     Manufacturing (import);
     Processing as a reactant/intermediate;
     Processing into formulation, mixture, or reaction product 
in cleaning and degreasing products;
     Processing into formulation, mixture, or reaction products 
in paint and coating products;
     Processing into formulation, mixture, or reaction products 
in adhesive and sealant products;
     Processing by repackaging;
     Industrial and commercial use as solvent for open-top 
batch vapor degreasing;
     Industrial and commercial use as solvent for closed-loop 
batch vapor degreasing;
     Industrial and commercial use as solvent for in-line 
conveyorized vapor degreasing;
     Industrial and commercial use as solvent for in-line web 
cleaner vapor degreasing;
     Industrial and commercial use in maskant for chemical 
milling;
     Industrial and commercial use in solvent-based adhesives 
and sealants; and
     Industrial and commercial use as a processing aid in 
catalyst regeneration in petrochemical manufacturing.
    Each owner or operator of a workplace where these conditions of use 
occur would be responsible for compliance with the ECEL and the 
associated requirements. EPA's description for how the requirements 
related to an ECEL would address the unreasonable risk resulting from 
inhalation exposures and the rationale for this regulatory approach are 
outlined in Units III.B.3. and V.A.
    If ambient exposures are kept at or below the 8-hour ECEL of 0.14 
ppm, EPA expects that a potentially exposed person in the workplace 
would be protected against non-cancer effects resulting from 
occupational exposures, as well as excess risk of cancer (Ref. 10).
    EPA is also proposing to establish an ECEL action level of 0.07 ppm 
as an 8-hour TWA for PCE. Air concentrations at or above the action 
level would trigger more frequent periodic monitoring of exposures to 
PCE, as described in this unit. EPA is proposing to adopt the action 
level approach in implementing the TSCA ECEL, consistent with the 
action level approach utilized by OSHA in the implementation of OSHA 
standards, although the values differ due to differing statutory 
authorities. As explained by OSHA, due to the variable nature of 
employee exposures, compliance with an action level provides employers 
with greater assurance that their employees will not be exposed to 
concentrations above the PELs (Ref. 42). EPA agrees with this reasoning 
and, like OSHA, expects the inclusion of an ECEL action level will 
stimulate innovation within industry to reduce exposures to levels 
below the action level. Therefore, EPA has identified a need for an 
action level for

[[Page 39673]]

PCE and is proposing a level that would be half the 8-hour ECEL, which 
is in alignment with the precedented approach established under most 
OSHA standards. EPA is soliciting 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.
    In summary, EPA is proposing that each owner or operator of a 
workplace subject to the ECEL must ensure that no person is exposed to 
airborne concentration of PCE in excess of 0.14 ppm (0.98 mg/m3) as an 
8-hour TWA (ECEL), with an action level identified as 0.07 ppm (0.47 
mg/m3) (ECEL action level). For conditions of use for which the 
requirements to meet an ECEL are being proposed, EPA expects that the 
regulated community can detect the ECEL and ECEL action level as they 
are above the threshold of PCE air sampling analytical methods that are 
widely available in commerce, currently in use, and approved by OSHA 
and NIOSH, which can range from <=0.5 parts per billion (ppb) to 9 ppm 
(Ref. 10). The Agency has also identified personal breathing zone air 
sampling devices with a minimum limit of quantitation and level of 
detection below the ECEL action level (Ref. 43). EPA is requesting 
comment on issues around the viability of current analytical methods 
and detection limits for occupational perchloroethylene sampling and/or 
monitoring methods. EPA's methodology and inputs for the ECEL value are 
directly derived from the peer reviewed analysis in the December 2020 
Risk Evaluation, which was also subject to public comment. As with all 
aspects of this rulemaking, the public is welcome to comment on the 
methodology for the ECEL value.
    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 PCE air 
concentration levels to near or below the ECEL. As discussed further in 
Unit V.A.1., for some conditions of use for which EPA is proposing the 
ECEL, data were submitted during the risk evaluation that indicate 
inhalation exposures may already be near or below the ECEL for some 
facilities, indicating that such facilities may already be in 
compliance with the proposed ECEL. As noted previously in this unit, 
EPA expects that, if inhalation exposures for affected occupational 
conditions of use are kept at or below the ECEL, potentially exposed 
persons reasonably likely to be exposed in the workplace would be 
protected from the unreasonable risk. EPA is also proposing to require 
owners or operators to comply with additional requirements under the 
WCPP that would be needed to ensure successful implementation of the 
ECEL.
    ii. Monitoring requirements. Overview. Monitoring requirements are 
a key component of implementing EPA's proposed WCPP. Initial monitoring 
for PCE is critical for establishing a baseline of exposure for 
potentially exposed persons; similarly, periodic exposure monitoring 
assures continued compliance so that potentially exposed persons in the 
workplace are not exposed to levels that would result in an 
unreasonable risk of injury. Periodic exposure monitoring frequency 
could change if certain conditions are met, which are described in this 
unit. Additionally, in some cases, a change in workplace conditions 
with the potential to impact exposure levels would warrant additional 
monitoring, which is also described. To ensure compliance with 
monitoring activities, EPA proposes exposure monitoring recordkeeping 
requirements outlined in this unit.
    Initial exposure monitoring. Under the proposed regulation, each 
owner or operator of a workplace where any condition of use listed 
earlier in this unit is occurring would be required to perform initial 
exposure monitoring to determine the extent of exposure of potentially 
exposed persons to PCE. Initial monitoring would notify owner or 
operators of the magnitude of possible exposures to their potentially 
exposed persons with respect to their unique work conditions and 
environments. The results of the initial exposure monitoring would 
determine the frequency of future periodic monitoring, whether 
additional exposure controls are necessary (such as engineering 
controls, administrative controls, and/or respiratory protection), and 
whether the owner or operator would need to demarcate a regulated area 
as described in this unit.
    EPA is proposing to require each owner or operator to establish an 
initial baseline monitoring sample to determine the magnitude of 
exposure for all persons who may be exposed to PCE within 6 months 
after the date of publication of the final rule in the Federal Register 
or within 30 days of introduction of PCE into the workplace, whichever 
is later. Where PCE is present in the workplace, each owner or operator 
would be required to determine each potentially exposed person's 
exposure by either taking a personal breathing zone air sample of each 
potentially exposed person or taking personal breathing zone air 
samples that are representative of each potentially exposed person's 
exposure performing the same or substantially similar operations in 
each work shift, in each job classification, and in each work area 
(hereinafter identified as an ``exposure group''). Representative 8-
hour TWA exposures must be determined based on one or more samples 
representing full-shift exposures for each shift for each person in 
each job classification in each work area. Monitoring samples must be 
taken when and where the operating conditions are best representative 
of each potentially exposed person's full-shift exposures. EPA expects 
that owners and operators would attempt to monitor a baseline for all 
of the tasks during the same timeframe; however, EPA understands that 
certain tasks occur less frequently, and EPA is soliciting comments 
regarding the timing of the initial exposure monitoring so that it 
would be representative of all tasks involving PCE where exposures may 
approach the ECEL. If the owner or operator chooses a representative 
sample, such sampling must include persons that are the closest to the 
source of PCE, so that the monitoring results are representative of the 
most highly exposed persons in the workplace. EPA is also soliciting 
comments regarding use of area sampling instead of personal breathing 
zone as a representative sample of exposures.
    EPA also recognizes that some entities may already have exposure 
monitoring data. If the owner or operator has monitoring data conducted 
within five years prior to the effective date of the final rule and the 
monitoring satisfies all other requirements of this section, including 
the requirement that the data represents the highest PCE exposures 
likely to occur under reasonably foreseeable conditions of use, the 
owner or operator may rely on such earlier monitoring results for the 
initial baseline monitoring sample.
    Periodic exposure monitoring. EPA is proposing to require each 
owner or operator to conduct, for those exposure groups that exceed the 
following airborne concentration levels, the following periodic 
monitoring:
     If all samples taken during the initial exposure 
monitoring reveal a concentration below the ECEL action level (<0.07 
ppm 8-hour TWA), the owner or operator must repeat the periodic 
exposure monitoring at least once every five years.
     If the most recent exposure monitoring indicates that 
airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA), the owner 
or operator

[[Page 39674]]

must repeat the periodic exposure monitoring within 3 months of the 
most recent exposure monitoring.
     If the most recent exposure monitoring indicates that 
airborne exposure is at or above the ECEL action level (>=0.07 ppm 8-
hour TWA) but at or below the ECEL (<=0.14 ppm 8-hour TWA), the owner 
or operator must repeat the periodic exposure monitoring within 6 
months of the most recent exposure monitoring.
     If the most recent (non-initial) exposure monitoring 
indicates that airborne exposure is below the ECEL action level, the 
owners or operators must repeat such monitoring within 6 months of the 
most recent monitoring until two consecutive monitoring measurements, 
taken at least seven days apart, are below the ECEL action level (<0.07 
ppm 8-hour TWA), at which time the owner or operator must repeat the 
periodic exposure monitoring at least once every 5 years.
    Additionally, in instances where an owner or operator does not 
manufacture, process, use, or dispose of PCE for a condition of use for 
which the WCPP is proposed over the entirety of time since the last 
required periodic monitoring event, EPA is proposing that the owner or 
operator would be permitted to forgo the next periodic monitoring 
event. However, documentation of cessation of use of PCE would be 
required and periodic monitoring would be required to resume should the 
owner or operator restart any of the conditions of use listed in unit 
IV.A.2. for which the WCPP is proposed.
    The proposed periodic monitoring requirements are also outlined in 
Table 1. EPA requests comment on the timeframes for periodic monitoring 
outlined in this unit. EPA may finalize significantly shorter or longer 
compliance timeframes based on consideration of public comments.

                Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
      Air concentration condition        Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is    Periodic exposure monitoring is
 below the ECEL action level.             required at least once every
(<0.07 ppm 8-hour TWA).................   five years.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is      required within 3 months of
 above the ECEL (>0.14 ppm 8-hour TWA).   the most recent exposure
                                          monitoring.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is at   required within 6 months of
 or above the ECEL action level but at    the most recent exposure
 or below the ECEL (>=0.07 ppm 8-hour     monitoring.
 TWA, <=0.14 ppm 8-hour TWA).
If the two most recent (non-initial)     Periodic exposure monitoring is
 exposure monitoring measurements,        required within 5 years of the
 taken at least seven days apart within   most recent exposure
 a 6 month period, indicate exposure is   monitoring.
 below the ECEL action level (<0.07 ppm
 8-hour TWA).
If the owner or operator engages in a    The owner or operator may forgo
 condition of use for which WCPP ECEL     the next periodic monitoring
 would be required but does not           event. However, documentation
 manufacture, process, use, or dispose    of cessation of use of PCE is
 of PCE in that condition of use over     required and periodic
 the entirety of time since the last      monitoring would be required
 required monitoring event.               when the owner or operator
                                          resumes the condition of use.
------------------------------------------------------------------------

    Additional exposure monitoring. In addition to the initial and 
periodic exposure monitoring, EPA is proposing that each owner or 
operator conduct additional exposure monitoring whenever a change in 
the production, process, control equipment, personnel, or work 
practices may reasonably be expected to result in new or additional 
exposures at or above the ECEL action level, or when the owner or 
operator has any reason to believe that new or additional exposures at 
or above the ECEL action level have occurred. In the event of start-up, 
shutdown, spills, leaks, ruptures or other breakdowns that may lead to 
employee exposure, EPA is proposing that each owner or operator must 
conduct additional initial exposure monitoring to potentially exposed 
persons (using personal breathing zone sampling) after the cleanup of 
the spill or repair of the leak, rupture or other breakdown. An 
additional exposure monitoring event may result in an increased 
frequency of periodic monitoring. For example, if the initial 
monitoring results from a workplace are above the ECEL action level, 
but below the ECEL, periodic monitoring is required every 6 months. If 
additional monitoring is performed because increased exposures are 
suspected, and the results are above the ECEL, subsequent periodic 
monitoring would have to be performed every 3 months. The required 
additional exposure monitoring should not delay implementation of any 
necessary cleanup or other remedial action to reduce the exposures to 
persons in the workplace.
    Other monitoring requirements. For each monitoring event, EPA is 
proposing to require owners or operators ensure that their methods be 
accurate, to a confidence level of 95 percent, to within plus or minus 
25 percent for airborne concentrations of PCE. Also, EPA is proposing 
to require use of appropriate sampling and analytical methods used to 
determine PCE exposure, including as relevant: (A) Use of an analytical 
method already approved by EPA, OSHA or NIOSH, or another analytical 
method that has been demonstrated to meet the proposed accuracy 
requirement at an appropriate level of detection for the ECEL and ECEL 
action level; (B) Compliance with the Good Laboratory Practice 
Standards at 40 CFR part 792. Additionally, EPA is proposing to require 
owners and operators to re-monitor within 15 working days after receipt 
of the results of any exposure monitoring when results indicate 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 is also proposing to require that each owner or operator 
maintain exposure monitoring records that include the following 
information for each monitoring event:
    (A) Dates, duration, and results of each sample taken;
    (B) All measurements that may be necessary to determine the 
conditions (e.g., work site temperatures, humidity, ventilation rates, 
monitoring equipment type and calibration dates) that may affect the 
monitoring results.
    (C) Name, workplace address, work shift, job classification, and 
work area of the person monitored; documentation of all potentially 
exposed persons whose exposures the monitoring is intended to represent 
if using a representative sample; and type of respiratory protective 
device worn by the monitored person, if any.

[[Page 39675]]

    (D) Use of appropriate sampling and analytical methods, such as 
analytical methods already approved by EPA, OSHA or NIOSH, or 
compliance with an analytical method verification procedure.
    (E) Compliance with the Good Laboratory Practice Standards at 40 
CFR part 792.
    (F) Information regarding air monitoring equipment, including: 
type, maintenance, calibrations, performance tests, limits of 
detection, and any malfunctions.
    iii. Incorporation of the hierarchy of controls. EPA is proposing 
to require owners or operators to implement the WCPP in accordance with 
the hierarchy of controls and encourages the use of pollution 
prevention to control exposures whenever practicable. Pollution 
prevention, also known as source reduction, is any practice that 
reduces, eliminates, or prevents pollution at its source (e.g., 
elimination and substitution). Similarly, the hierarchy of controls 
includes, in order of preference, elimination, substitution, 
engineering controls, and administrative controls, prior to relying on 
PPE as a means of controlling exposures (Ref. 8). EPA is proposing to 
require owners or operators to reduce inhalation exposures below the 
ECEL in accordance with the hierarchy of controls. EPA expects that, 
for conditions of use for which EPA is proposing a WCPP, compliance at 
most workplaces would be part of an existing industrial hygiene 
program. Workplaces that cannot feasibly eliminate the source of PCE 
emissions or replace PCE with a substitute would have to use 
engineering and/or administrative controls to implement process changes 
to reduce exposures to the extent feasible, following the hierarchy of 
controls (Ref. 8). If an owner or operator chooses to replace PCE with 
a substitute, EPA recommends that they carefully review the available 
hazard and exposure information on the potential substitutes to avoid a 
substitute chemical that might later be found to present unreasonable 
risks or be subject to regulation (sometimes referred to as a 
``regrettable substitution'').
    If an effort to identify and implement feasible exposure controls 
such as elimination, substitution, engineering controls, and 
administrative controls are not sufficient to reduce exposures to or 
below the ECEL for all persons in the workplace, EPA proposes to 
require each owner or operator to use such controls to reduce PCE 
concentrations in the workplace to the lowest levels achievable and, 
only after levels cannot be further reduced, supplement these controls 
using respiratory protection before persons are permitted to enter a 
regulated area, as described in this unit. In such cases, EPA would 
require that the owner or operator provide those persons exposed or who 
may be exposed to PCE by inhalation above the ECEL with respirators 
sufficient to ensure that their exposures do not exceed the ECEL, as 
described in this unit. EPA also proposes to require that each owner or 
operator document their evaluation of elimination, substitution, 
engineering and administrative exposure control strategies, and if 
applicable the reasons why they found these strategies infeasible to 
control exposures below the ECEL, in an exposure control plan as 
described in this unit. In addition, a regulated entity would be 
prohibited from rotating work schedules of potentially exposed persons 
to comply with the ECEL 8-hour TWA. EPA may require more, less, or 
different documentation regarding exposure control strategies in the 
final rule based on consideration of public comments.
    iv. Regulated area. Based on the exposure monitoring, EPA is 
proposing to require that owners or operators of workplaces subject to 
a WCPP demarcate any area where airborne concentrations of PCE exceed 
or are reasonably expected to exceed the ECEL. Regulated areas would be 
demarcated using administrative controls, such as warning signs or 
highly visible signifiers, in multiple languages as appropriate (e.g., 
based on languages spoken by potentially exposed persons), placed in 
conspicuous areas, and documented through training and recordkeeping. 
The owner or operator would be required to restrict access to the 
regulated area from any potentially exposed person that lacks proper 
training, is not wearing required PPE as described in this unit or is 
otherwise unauthorized to enter. EPA is proposing to require owners and 
operators demarcate a regulated area beginning 9 months after the date 
of publication of the final rule, or within 3 months after receipt of 
any exposure monitoring that indicates exposures exceeding the ECEL. 
EPA is soliciting comment on requiring warning signs to demarcate 
regulated areas, such as the requirements found in OSHA's General 
Industry Standard for Beryllium (29 CFR 1910.1024(m)(2)).
    v. Notification of monitoring results. EPA proposes that the owner 
or operator must, within 15 working days after receipt of the results 
of any exposure monitoring, notify each person whose exposure is 
represented by that monitoring in writing, either individually to each 
potentially exposed person or by posting the information in an 
appropriate and accessible location accessible to all persons whose 
exposure is represented by the monitoring, such as public spaces or 
common areas, outside the regulated area. This notice must include the 
exposure monitoring results, identification and explanation of the ECEL 
and ECEL action level in plain language, any corresponding required 
respiratory protection, if applicable, the quantity, location, manner 
of PCE use and identified releases of PCE that could result in exposure 
to PCE, and whether the airborne concentration of PCE exceeds the ECEL 
limit. The notice must also include a description of actions taken by 
the owner or operator to reduce inhalation exposures to or below the 
ECEL, if applicable, or refer to a document available to the 
potentially exposed persons which states the actions to be taken to 
reduce exposures, and be posted in multiple languages if necessary 
(e.g., notice must be in a language that the potentially exposed person 
understands, including a non-English language version representing the 
language of the largest group of workers who cannot readily comprehend 
or read English).
c. Direct Dermal Contact Control Requirements
    i. Direct dermal contact. DDCC requirements are a process-based set 
of provisions to address unreasonable risk driven by dermal exposure by 
preventing direct dermal contact in the workplace. In order to address 
the unreasonable risk driven by dermal exposure to PCE, DDCC 
requirements would include controls to separate, distance, physically 
remove, or isolate all person(s) from direct handling of PCE or from 
skin contact with surfaces that may be contaminated with PCE (i.e., 
equipment or materials on which PCE may be present) under routine 
conditions in the workplace (hereafter referred to as direct dermal 
contact). For purposes of DDCC requirements, direct dermal contact with 
PCE does not include vapor exposures through the skin, although EPA 
recommends and encourages owners and operators to implement control 
measures to prevent or reduce dermal exposures to airborne PCE vapors. 
The 2020 Risk Evaluation for PCE identified that unreasonable risk to 
workers is also driven by the dermal exposure, specifically from direct 
skin contact with PCE; risk exceeding the benchmark was identified even 
when considering use of chemically resistant gloves in most commercial 
and

[[Page 39676]]

industrial conditions of use. EPA's description for how the 
requirements related to DDCC would address the unreasonable risk 
resulting from dermal exposures and the rationale for this regulatory 
approach is outlined in Units III.B.3. and V.A.
    Similar to the ECEL, under DDCC requirements, EPA is proposing to 
require owners and operators implement dermal exposure controls in 
accordance with the hierarchy of controls. EPA also recommends and 
encourages the use of pollution prevention as a means of controlling 
exposures whenever practicable. In addition to the conditions of use 
for which EPA is proposing to require a WCPP ECEL, EPA is also 
proposing WCPP DDCC requirements for the following conditions of use: 
recycling and disposal.
    Within certain parameters outlined in this unit, DDCC requirements 
are non-prescriptive to allow more flexibility to owners and operators 
to choose their controls to prevent direct dermal contact when compared 
with prescriptive requirements for specific controls. Each owner or 
operator of a workplace engaging in a condition of use for which DDCC 
requirements are proposed would be responsible for compliance with the 
DDCC requirements and recordkeeping.
    As discussed briefly in Unit IV.A.1. and further in Unit V.A.1., 
EPA expects that many workplaces already have stringent controls in 
place that reduce dermal exposures to PCE; for some workplaces, EPA 
understands that these existing controls may already prevent or reduce 
direct dermal contact with PCE.
    ii. Incorporation of the hierarchy of controls. As with the 
requirements to meet an ECEL, EPA is proposing to require owners or 
operators to implement DDCC requirements in accordance with the 
hierarchy of controls and encourages the use of pollution prevention to 
control exposures whenever practicable. EPA recognizes that some owners 
or operators may have industrial hygiene practices already preventing 
direct dermal contact with PCE in the workplace. For workplaces that 
cannot feasibly eliminate the source of PCE dermal exposure or replace 
PCE with a substitute, workplaces would have to use engineering and/or 
administrative controls to implement process changes to prevent direct 
dermal contact with PCE to the extent feasible. If an owner or operator 
chooses to replace PCE with a substitute, EPA recommends that they 
carefully review the available hazard and exposure information on the 
potential substitutes to avoid a regrettable substitution. If an effort 
to identify and implement feasible exposure controls such as 
elimination, substitution, engineering controls and administrative 
controls is not sufficient to prevent direct dermal contact with PCE 
for potentially exposed persons in the workplace, EPA proposes to 
require each owner and operator to reduce potential for direct dermal 
contact with PCE in the workplace by these controls and to supplement 
these controls using PPE.
    Examples of engineering controls that may prevent or reduce the 
potential for direct dermal contact include automation, physical 
barriers between contaminated and clean work areas, enclosed transfer 
liquid lines (with purging mechanisms in place (e.g., nitrogen, 
aqueous) for operations such as product changes or cleaning), and 
design of tools (e.g., a closed-loop container system providing 
contact-free connection for unloading fresh and collecting spent 
solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples 
of administrative controls that may prevent or reduce the potential for 
direct dermal contact include adjusting work practices (i.e., 
implementing policies and procedures) such as providing safe working 
distances from areas where direct handling of PCE may occur.
    EPA requests comment on available methods to measure the 
effectiveness of engineering and administrative controls in preventing 
or reducing the potential for direct dermal contact to PCE. EPA is also 
requesting comment on available monitoring methods, such as charcoal 
patch testing, as feasible or effective methods to measure potential 
direct dermal contact with PCE.
    EPA proposes to require that owners and operators document their 
implementation efforts and compliance with DDCC requirements in an 
exposure control plan or through any existing documentation of the 
facility's ``Safety and Health Program'' that may already be developed 
as part of meeting OSHA requirements or other safety and health 
standards (Ref. 44), as described in Unit IV.A.2.e.
d. Personal Protective Equipment (PPE) Program
    Where elimination, substitution, engineering controls, and 
administrative controls are not feasible to reduce the air 
concentration to or below the ECEL and/or prevent direct dermal contact 
with PCE for all potentially exposed persons, EPA is proposing to 
require implementation of a PPE program in alignment with OSHA's 
General Requirements for Personal Protective Equipment at 29 CFR 
1910.132. Consistent with 29 CFR 1910.132, owners and operators would 
be required to provide PPE, including respiratory protection and dermal 
protection selected in accordance with the guidelines described in this 
unit, that is of safe design and construction for the work to be 
performed. EPA is proposing to require owners and operators ensure each 
potentially exposed person who is required by this unit to wear PPE to 
use and maintain PPE in a sanitary, reliable, and undamaged condition. 
Owners and operators would be required to select and provide PPE that 
properly fits each potentially exposed person who is required by this 
unit to use PPE and communicate PPE selections to each affected person.
    As part of the PPE program, EPA is also proposing that owners and 
operators must comply with OSHA's general PPE training requirements at 
29 CFR 1910.132(f) for application of a PPE training program, including 
providing training on proper use of PPE (e.g., when and where PPE is 
necessary, proper application, wear, and removal of PPE, maintenance, 
useful life and disposal of PPE). EPA is proposing that owners and 
operators would provide PPE training to each potentially exposed person 
who is required by this unit to wear PPE prior to or at the time of 
initial assignment to a job involving potential exposure to PCE. Owners 
and operators would also have to re-train each affected person at least 
once annually or whenever the owner or operator has reason to believe 
that a previously trained person does not have the required 
understanding and skill to properly use PPE, or when changes in the 
workplace or in the PPE to be used render the previous training 
obsolete.
    This unit includes a description of the PPE Program, including 
proposed PPE as it relates to respiratory protection, proposed PPE as 
it relates to dermal protection, and other proposed requirements such 
as additional training for respirators and recordkeeping to support 
implementation of a PPE program.
    i. Respiratory protection. Where elimination, substitution, 
engineering, and administrative controls are not feasible to reduce the 
air concentration to or below the ECEL, EPA proposes to set minimum 
respiratory PPE requirements based on an entity's most recent measured 
air concentration and the level of PPE that EPA determined would be 
needed to reduce exposure to the ECEL. In those circumstances, EPA is 
proposing to require a respiratory protection PPE program with 
worksite-specific procedures and elements for

[[Page 39677]]

required respirator use. The respiratory protection PPE program 
proposed by EPA would be based on the most recent exposure monitoring 
concentration measured as an 8-hour TWA and would be administered by a 
suitably trained program administrator. EPA is also proposing to 
require each owner or operator select respiratory protection in 
accordance with the guidelines described in this unit and 29 CFR 
1910.134(a) through (l), except (d)(1)(iii), for proper respirator use, 
maintenance, fit-testing, medical evaluation, and training. EPA is not 
proposing to cross reference 29 CFR 1910.134(d)(1)(iii) because the 
WCPP contains requirements for identifying PCE respiratory hazards in 
the workplace.
    Required Respiratory Protection. EPA is proposing to require each 
owner or operator supply a respirator, selected in accordance with this 
unit, to each person who enters a regulated area within 3 months after 
the receipt of any exposure monitoring that indicates exposures 
exceeding the ECEL and thereafter must ensure that all persons within 
the regulated area are using the provided respirators whenever PCE 
exposures exceed or can reasonably be expected to exceed the ECEL. 
Given the risks associated with PCE exposure above the ECEL, prompt 
compliance with the respiratory protection requirements is important, 
but EPA expects that most owners or operators will need some time after 
the exposure monitoring results are received to acquire the correct 
respirators and establish a respiratory protection program, including 
training, fit-testing, and medical evaluations. EPA believes that 3 
months should be sufficient for this purpose. EPA is also proposing 
that owners or operators who would be required to administer a 
respiratory protection program must supply a respirator selected in 
accordance with 29 CFR 1910.134(d)(1) (except (d)(1)(iii)). 
Additionally, EPA is proposing that the owner or operator must ensure 
that all filters, cartridges and canisters used in the workplace are 
labeled and color coded with the NIOSH approval label and that the 
label is not removed and remains legible. 29 CFR 1910.134(d)(3)(iii), 
which EPA is proposing to cross-reference, requires either the use of 
respirators with an end-of-life service indicator certified by NIOSH 
for the contaminant, in this case PCE, or implementation of a change 
schedule for canisters and cartridges that ensures that they are 
changed before the end of their service life. EPA is requesting comment 
on whether there should be a requirement to replace cartridges or 
canisters after a certain number of hours, such as the requirements 
found in OSHA's General Industry Standard for 1,3-Butadiene (29 CFR 
1910.1051(h)), or a requirement for a minimum service life of non-
powered air-purifying respirators such as the requirements found in 
OSHA's General Industry Standard for Benzene (29 CFR 
1910.1028(g)(3)(D)).
    EPA is proposing the following requirements for respiratory 
protection, based on the exposure monitoring concentrations measured as 
an 8-hour TWA that exceed the ECEL (0.14 ppm). EPA is proposing to 
establish minimum respiratory protection requirements, such that any 
respirator affording a higher degree of protection than the following 
proposed requirements may be used. While this unit includes respirator 
selection requirements for respirators of assigned protection factors 
(APFs) of 1,000 or greater, EPA does not anticipate that respirators 
beyond APF 25 will be widely or regularly used to address unreasonable 
risk, particularly when other controls are put in place.
     If the measured exposure concentration is at or below 0.14 
ppm: no respiratory protection is required.
     If the measured exposure concentration is above 0.14 ppm 
and less than or equal to 0.7 ppm (5 times ECEL): Any NIOSH-certified 
air-purifying quarter mask respirator (APF 5).
     If the measured exposure concentration is above 0.7 ppm 
and less than or equal to 1.4 ppm (10 times ECEL): Any NIOSH-certified 
air-purifying half mask or full facepiece respirator equipped with 
NIOSH-approved organic vapor cartridges or canisters (APF 10).
     If the measured exposure concentration is above 1.4 ppm 
and less than or equal to 3.5 ppm (25 times ECEL): Any NIOSH-certified 
air-purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; any NIOSH-certified powered air-
purifying respirator equipped with NIOSH-approved organic vapor 
cartridges; or any NIOSH-certified continuous flow supplied air 
respirator equipped with a hood or helmet (APF 25).
     If the measured exposure concentration is above 3.5 ppm 
and less than or equal to 7.0 ppm (50 times ECEL): Any NIOSH-certified 
air-purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; or any NIOSH-certified powered 
air-purifying respirator equipped with a tight-fitting facepiece and a 
NIOSH-approved organic vapor cartridge (APF 50).
     If the measured exposure concentration is above 7.0 ppm 
and less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH-
certified supplied air respirator equipped with a half mask or full 
facepiece and operated in a pressure demand or other positive pressure 
mode (APF 1,000).
     If the measured exposure concentration is greater than 140 
ppm (1,000 times ECEL) or the concentration is unknown: Any NIOSH-
certified self-contained breathing apparatus (SCBA) equipped with a 
full facepiece and operated in a pressure demand or other positive 
pressure mode; or any NIOSH-certified supplied air respirator equipped 
with a full facepiece and operated in a pressure demand or other 
positive pressure mode in combination with an auxiliary SCBA operated 
in a pressure demand or other positive pressure mode (APF 10,000).
    EPA proposes to require that owners and operators document 
respiratory protection used and PPE program implementation. EPA 
proposes to require that owners and operators document in the exposure 
control plan or other documentation of the facility's safety and health 
program information relevant to respiratory program, including records 
on the name, workplace address, work shift, job classification, work 
area, and type of respirator worn (if any) by each potentially exposed 
person, maintenance, and fit-testing, as described in 29 CFR 
1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29 
CFR 1910.134(k).
    ii. Dermal protection. Where elimination, substitution, engineering 
controls, and administrative controls are not feasible or sufficient to 
fully prevent direct dermal contact with PCE, EPA is proposing to 
require that appropriate dermal PPE be provided by owners and operators 
to, and be worn by, persons potentially exposed to direct dermal 
contact with PCE. To accomplish this, EPA is proposing owners and 
operators follow the dermal PPE requirements for PPE selection laid out 
in this unit.
    Required Dermal Protection. In choosing appropriate dermal PPE, 
owners and operators would be required to select gloves, clothing, and 
protective gear (which covers any exposed dermal area of arms, legs, 
torso, and face) based on specifications from the manufacturer or 
supplier that demonstrate an impervious barrier to PCE during expected 
durations of use and normal conditions of exposure within the 
workplace, accounting for potential chemical permeation or breakthrough

[[Page 39678]]

times. In alignment with the OSHA Hand Protection PPE Standard (29 CFR 
1910.138), owners and operators would be required to select dermal PPE 
based on an evaluation of the performance characteristics of the PPE 
relative to the task(s) to be performed, conditions present, and the 
duration of use. Further information related to choosing appropriate 
PPE can be found in the summary of suitable gloves for PCE memo (Ref. 
45).
    For example, owners and operators can select gloves that have been 
tested in accordance with the American Society for Testing and 
Materials (ASTM) F739 ``Standard Test Method for Permeation of Liquids 
and Gases through Protective Clothing Materials under Conditions of 
Continuous Contact.'' EPA is proposing that PPE be provided for use for 
a time period only to the extent and no longer than the time period for 
which testing has demonstrated that the PPE will be impermeable during 
expected durations of use and conditions of exposure. EPA is proposing 
to require that owners and operators also consider other factors when 
selecting appropriate PPE, including effectiveness of glove type when 
preventing exposures from PCE alone and in likely combination with 
other chemical substances used in the work area or when used with glove 
liners, permeation, degree of dexterity required to perform task, and 
temperature, as identified in the Hand Protection section of OSHA's 
Personal Protective Equipment Guidance (Ref. 46).
    EPA is proposing that owners and operators would be required to 
establish, either through manufacturer or supplier-provided 
documentation or individually prepared 3rd party testing that the 
selected PPE will be impervious for the expected duration and 
conditions of exposure, such as using the format specified in ASTM 
F1194-99(2010) ``Standard Guide for Documenting the Results of Chemical 
Permeation Testing of Materials Used in Protective Clothing 
Materials,'' reporting cumulative permeation rate as a function of 
time, or equivalent manufacturer- or supplier- provided testing. Owners 
and operators would also be required to consider likely combinations of 
chemical substances to which the clothing may be exposed in the work 
area when selecting the appropriate PPE such that the PPE will prevent 
direct dermal contact to PCE. EPA is proposing that PPE must be 
immediately provided and replaced if any person is dermally exposed to 
PCE longer than the breakthrough time period for which testing has 
demonstrated that the PPE will be impermeable or if there is a chemical 
permeation or breakage of the PPE.
    Additionally, EPA is proposing to require that owners and operators 
subject to this rule comply with provisions of 29 CFR 1910.133(b) for 
requirements on selection and use of eye and face protection. EPA is 
soliciting comments on the requirements proposed for appropriate PPE 
selection, the effectiveness of PPE in preventing direct dermal contact 
with PCE in the workplace, and general absorption and permeation 
effects to PPE from direct dermal exposure. In addition, EPA 
understands that some workplaces rinse and reuse PPE after minimal use 
and is therefore soliciting comments on the impact on effectiveness of 
rinsing and reusing certain types of PPE, either gloves or protective 
clothing and gear. EPA also requests comment on the degree to which 
additional guidance related to use of PPE might be appropriate.
    EPA is also proposing that owners and operators retain records of 
dermal PPE used and program implementation. EPA proposes to require 
that owners and operators document in the exposure control plan or 
other documentation of the facility's safety and health program, 
information relevant to any dermal PPE program, as applicable, 
including: (A) The name, workplace address, work shift, job 
classification, and work area of each person reasonably likely to 
directly handle PCE or handle equipment or materials on which PCE may 
present and the type of PPE selected to be worn by each of these 
persons; (B) The basis for specific PPE selection (e.g., demonstration 
based on permeation testing or manufacturer specifications that each 
item of PPE selected provides an impervious barrier to prevent exposure 
during expected duration and conditions of exposure, including the 
likely combinations of chemical substances to which the PPE may be 
exposed in the work area); (C) Appropriately sized PPE and training on 
proper application, wear, and removal of PPE, and proper care/disposal 
of PPE; (D) Occurrence and duration of any direct dermal contact with 
PCE that occurs during any activity or malfunction at the workplace 
that causes direct dermal exposures to occur and/or glove breakthrough, 
and corrective actions to be taken during and immediately following 
that activity or malfunction to prevent direct dermal contact to PCE; 
and (E) Training in accordance with 29 CFR 1910.132(f), including any 
re-training. EPA may require more, less, or different documentation in 
the final rule based on consideration of public comments.
e. General WCPP Requirements
    i. Exposure Control Plan. EPA proposes to require that owners and 
operators document their exposure control strategy and implementation 
in an exposure control plan or through adding EPA-required information 
to any existing documentation of the facility's safety and health 
program developed as part of meeting OSHA requirements or other safety 
and health standards. EPA proposes to require that each owner or 
operator document in the exposure control plan the following:
    (A) Identification and rationale of exposure controls used or not 
used in the following sequence: elimination of PCE, substitution of 
PCE, engineering controls, and administrative controls to reduce 
exposures in the workplace to either at or below the ECEL or to the 
lowest level achievable and to prevent or reduce direct dermal contact 
with PCE in the workplace;
    (B) The exposure controls selected based on feasibility, 
effectiveness, and other relevant considerations;
    (C) If exposure controls were not selected, document the efforts 
identifying why these are not feasible, not effective, or otherwise not 
implemented;
    (D) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training or other steps 
taken;
    (E) Description of any regulated area and how it is demarcated, and 
identification of authorized persons; and description of when the owner 
or operator expects exposures may be likely to exceed the ECEL;
    (F) Regular inspections, evaluations, and updating of the exposure 
controls to ensure effectiveness and confirmation that all persons are 
implementing them as required;
    (G) Occurrence and duration of any start-up, shutdown, or 
malfunction of the facility that causes air concentrations to be above 
the ECEL or any direct dermal contact with PCE and subsequent 
corrective actions taken during start-up, shutdown, or malfunctions to 
mitigate exposures to PCE; and
    (H) Availability of the exposure control plan and associated 
records for potentially exposed persons.
    ii. Workplace Information and Training. EPA is also proposing to 
require implementation of a training program in alignment with the OSHA 
Hazard Communication Standard (29 CFR 1910.1200) and the OSHA General 
Industry Standard for Methylene

[[Page 39679]]

Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons 
in the workplace are informed of the hazards associated with PCE 
exposure, EPA is proposing to require that owners or operators of 
workplaces subject to the WCPP institute a training and information 
program for potentially exposed persons and assure their participation 
in the training and information program.
    As part of the training and information program, the owner or 
operator would be required to provide information and comprehensive 
training in an understandable manner (i.e., plain language) and in 
multiple language as appropriate (e.g., based on languages spoken by 
potentially exposed persons) to potentially exposed persons prior to or 
at the time of initial assignment to a job involving potential exposure 
to PCE. In alignment with the OSHA Hazard Communication Standard, 
owners and operators would be required to provide information and 
training to all potentially exposed persons that includes (A) the 
requirements of the PCE WCPP and how to access or obtain a copy of the 
requirements of the WCPP; (B) the quantity, location, manner of use, 
release, and storage of PCE and the specific operations in the 
workplace that could result in PCE exposure; (C) principles of safe use 
and handling of PCE in the workplace, including specific measures the 
owner or operator has implemented to reduce inhalation exposures to at 
or below the ECEL or prevent direct dermal contact with PCE, such as 
work practices and PPE used; (D) the methods and observations that may 
be used to detect the presence or release of PCE in the workplace (such 
as monitoring conducted by the owner or operator, continuous monitoring 
devices, visual appearance or odor of PCE when being released, etc.); 
and (E) the health hazards associated with exposure with PCE.
    In addition to providing training at the time of initial assignment 
to a job involving potential exposure to PCE, and in alignment with the 
OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners 
and operators subject to the PCE WCPP would be required to re-train 
each potentially exposed person annually to ensure they understand the 
principles of safe use and handling of PCE in the workplace. Owners and 
operators would also need to update the training as necessary whenever 
there are changes in the workplace, such as new tasks or modifications 
of tasks; in particular, whenever there are changes in the workplace 
that increase exposure to PCE or where potentially exposed persons' 
exposure to PCE can reasonably be expected to exceed the action level 
or increase the potential for direct dermal contact with PCE. To 
support compliance, EPA is proposing that each owner or operator of a 
workplace subject to the WCPP would be required to provide to the EPA, 
upon request, all available materials related to workplace information 
and training.
    iii. Workplace Participation. EPA encourages owners or operators to 
consult with persons that have potential for exposure on the 
development and implementation of exposure control plans and PPE/
respirator programs. EPA is proposing to require owners or operators to 
provide potentially exposed persons or their designated representatives 
regular access to the exposure control plans, exposure monitoring 
records, and PPE program implementation and documentation. To ensure 
compliance in workplace participation, EPA is proposing that the owner 
or operator document the notice to and ability of any potentially 
exposed person that may reasonably be affected by PCE inhalation 
exposure or direct dermal contact with PCE to readily access the 
exposure control plans, facility exposure monitoring records, PPE 
program implementation, or any other information relevant to PCE 
exposure in the workplace. EPA is requesting comment on how owners and 
operators can engage with potentially exposed persons on the 
development and implementation of an exposure control plan and PPE 
program.
    iv. Recordkeeping. To support and demonstrate compliance, EPA is 
proposing that each owner or operator of a workplace subject to WCPP 
retain compliance records for five years. EPA is proposing to require 
records to include:
    (A) the exposure control plan;
    (B) PPE program implementation and documentation, including as 
necessary, respiratory protection and dermal protection used and 
related PPE training; and
    (C) information and training provided to each person prior to or at 
the time of initial assignment and any re-training.
    In addition, EPA is proposing that owners and operators subject to 
the WCPP ECEL requirements maintain records to include:
    (D) The exposure monitoring records;
    (E) Notification of exposure monitoring results; and
    (F) To the extent that the owner or operator relies on prior 
exposure monitoring data, records that demonstrates that it meets all 
of the requirements of this section.
    The owners and operators, upon request by EPA, would be required to 
make all records that are maintained as described in this unit 
available to EPA for examination and copying in accordance with EPA 
requirements. All records required to be maintained by this unit could 
be kept in the most administratively convenient form (electronic or 
paper).
    v. Compliance timeframes. EPA is proposing to require each owner or 
operator of a workplace subject to an ECEL conduct initial baseline 
monitoring according to the process outlined in this unit by 6 months 
after date of publication of the final rule in the Federal Register or 
within 30 days of introduction of PCE into the workplace if PCE use 
commences at least 6 months after the date of publication. EPA is 
proposing to require each owner or operator ensure that the airborne 
concentration of PCE does not exceed the ECEL for all potentially 
exposed persons within 9 months after the date of publication of the 
final rule in the Federal Register, or beginning 4 months after 
introduction of PCE into the workplace if PCE use commences at least 6 
months after the date of publication. EPA is also proposing to require 
owners and operators demarcate and maintain a regulated area wherever 
exposures exceed or can reasonably be expected to exceed the ECEL 
beginning 9 months after the date of publication of the final rule in 
the Federal Register, or beginning 4 months after introduction of PCE 
into the workplace if PCE use commences at least 6 months after the 
date of publication. If applicable, EPA is also proposing that each 
owner or operator must provide respiratory protection sufficient to 
reduce inhalation exposures to below the ECEL to all potentially 
exposed persons in the regulated area within 3 months after receipt of 
the results of any exposure monitoring that indicates exposures 
exceeding the ECEL or, if using monitoring data conducted within five 
years prior to the effective date of this rule that satisfies all other 
requirements of this section, within 9 months after the date of 
publication of the final rule in the Federal Register. Regulated 
entities should then proceed accordingly to implement an exposure 
control plan within 12 months after date of publication of the final 
rule in the Federal Register. EPA requests comment relative to the 
ability of owners or operators to conduct initial monitoring within 6 
months after date of publication of the final rule in the Federal 
Register, and anticipated timelines for any procedural

[[Page 39680]]

adjustments needed to comply with the requirements outlined in this 
unit, including establishment of a respiratory protection program and 
development of an exposure control plan.
    With regard to the compliance timeframe for those occupational 
conditions of use which are subject to DDCC requirements, EPA is 
proposing to require each owner and operator of a workplace subject to 
DDCC establish the process outlined in this unit by 12 months after 
publication of the final rule in the Federal Register. EPA requests 
comment relative to the ability of owners or operators to implement 
such processes within 12 months of publication of the final rule in the 
Federal Register, and anticipated timelines for any procedural 
adjustments needed to comply with the requirements outlined in this 
unit. EPA may finalize significantly shorter or longer compliance 
timeframes based on consideration of public comments.
3. Prescriptive Controls
a. Overview
    In contrast to the proposed non-prescriptive requirements of the 
ECEL and DDCC where regulated entities would have flexibility to select 
controls in accordance with the hierarchy of controls to comply with 
the parameters outlined in this unit, EPA may also find it appropriate 
in certain circumstances to require specific prescriptive controls for 
certain occupational conditions of use. In the 2020 Risk Evaluation for 
PCE, EPA identified certain workplace controls that reduce exposures 
from PCE adequate to address the unreasonable risk driven by inhalation 
exposures from the industrial and commercial use of PCE in laboratory 
chemicals. Therefore, EPA is proposing to require specific prescriptive 
controls for the industrial and commercial use of PCE in laboratory 
chemicals, as described in this unit. This unit describes proposed 
requirements for a fume hood and dermal PPE for the industrial and 
commercial use of PCE in laboratory chemicals, including additional 
requirements proposed for recordkeeping. This unit also describes 
compliance timeframes for these proposed requirements.
b. Workplace Requirements for Laboratory Use
    To reduce exposures in the workplace and address the unreasonable 
risk of injury to health resulting from dermal exposures to PCE 
identified for the industrial and commercial use as a laboratory 
chemical, EPA is proposing to require dermal PPE in combination with 
comprehensive training for tasks particularly related to the use of PCE 
in a laboratory setting as specified in this unit for each potentially 
exposed person to direct dermal contact with PCE. Additionally, EPA is 
proposing to require the use of fume hoods in workplaces engaged in the 
laboratory chemical condition of use 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). Each 
owner or operator of a workplace where the industrial and commercial 
use of PCE as a laboratory chemical occurs would be responsible for 
compliance with the requirements outlined in this unit. EPA's 
description for how these requirements would address the unreasonable 
risk and the rationale for this regulatory approach is outlined in Unit 
III.B.3. and Unit V.A.
    EPA is proposing to require dermal PPE, including impermeable 
gloves and protective clothing, in combination with comprehensive 
training for tasks where there is potential for direct dermal contact 
with PCE (see Unit IV.A.2.d.). In selecting and providing appropriate 
dermal PPE and providing PPE training, owners and operators would be 
required to follow the PPE program and dermal protection requirements 
laid out in Unit IV.A.2.d.ii. Unlike DDCC, this proposed provision 
would not require owners and operators to use elimination, 
substitution, engineering controls, and administrative controls, prior 
to relying on PPE, as a means of controlling exposures in accordance 
with the hierarchy of controls.
    For laboratory fume hoods, EPA is proposing to require each owner 
or operator of a workplace engaged in the laboratory chemical condition 
of use to ensure fume hoods are in use and functioning properly to 
minimize exposures to potentially exposed persons in the area where PCE 
is used as a laboratory chemical. EPA suggests owners or operators 
refer to OSHA's 29 CFR 1910.1450, appendix A National Research Council 
Recommendations Concerning Chemical Hygiene in Laboratory, for 
ventilation system characteristics and practices to minimize exposures 
to workers in the area. As noted in these non-mandatory 
recommendations, which are based on the National Research Council's 
2011 edition of ``Prudent Practices in the Laboratory: Handling and 
Management of Chemical Hazards,'' recommended practices for laboratory 
chemical hoods include, but are not limited to, regularly inspecting 
and maintaining the ventilation system, ensuring a negative pressure 
differential between the amount of air exhausted from the laboratory 
and the amount supplied to the laboratory to prevent uncontrolled 
chemical vapors from leaving the laboratory, and preventing laboratory 
air from recirculating back into the laboratory (Ref. 47). EPA requests 
comment on whether it should incorporate in the rule best practices to 
ensure proper and adequate performance of laboratory fume hoods, such 
as those identified in OSHA's 29 CFR 1910.1450, Appendix A National 
Research Council Recommendations Concerning Chemical Hygiene in 
Laboratory.
    To support and demonstrate compliance, EPA is proposing that each 
owner or operator of a laboratory workplace subject to the requirements 
of this unit retain compliance records for five years. EPA is proposing 
to require records to include: (A) PPE program implementation and 
documentation as outlined in this unit; and (B) Implementation of a 
properly functioning fume hood using manufacturer's instructions for 
installation, use, and maintenance of the fume hood, including 
inspections, tests, development of maintenance procedures, the 
establishment of criteria for acceptable test results, and 
documentation of test and inspection results. Every five years, the 
owner or operator would be required to update these records.
    EPA is proposing to require that each owner or operator of a 
workplace engaged in the industrial and commercial use of PCE as a 
laboratory chemical ensure fume hoods are in use and functioning 
properly and dermal PPE is provided to all potentially exposed persons 
to direct dermal contact with PCE according to the process outlined in 
this unit within 12 months after publication of the final rule. EPA 
requests comment relative to the ability of owners or operators to 
implement laboratory chemical fume hood and dermal PPE related 
requirements within 12 months of publication of the final rule, and 
anticipated timelines for any procedural adjustments needed to comply 
with the requirements outlined in this unit. EPA may finalize 
significantly shorter or longer compliance timeframes based on 
consideration of public comments.
4. Other Requirements
a. Recordkeeping
    In addition to the recordkeeping requirements for the WCPP and 
prescriptive controls outlined in this unit, for conditions of use that 
are not otherwise prohibited under this

[[Page 39681]]

proposed regulation, EPA is also proposing that manufacturers, 
processors, distributors, and commercial users maintain ordinary 
business records, such as invoices and bills-of-lading, that 
demonstrate compliance with the prohibitions, restrictions, and other 
provisions of this proposed regulation; and to maintain such records 
for a period of 5 years from the date the record is generated. EPA is 
proposing that this requirement begin at the effective date of the rule 
(60 days following publication of the final rule in the Federal 
Register). Recordkeeping requirements would ensure that owners or 
operators can demonstrate compliance with the regulations if necessary. 
EPA may require more, less, or different documentation in the final 
rule based on consideration of public comments.
b. Downstream Notification
    For conditions of use that are not otherwise prohibited under this 
proposed regulation, EPA is proposing that manufacturers (including 
importers), processors, and distributors, excluding retailers, of PCE 
and PCE-containing products provide downstream notification of the 
prohibitions through the Safety Data Sheets (SDS) required by OSHA 
under 29 CFR 1910.1200(g) by adding to sections 1(c) and 15 of the SDS 
the following language:

    After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be 
distributed in commerce to retailers for any use. After [DATE 21 
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL 
REGISTER], this chemical/product is and can only be distributed in 
commerce or processed for the following purposes: Processing as a 
reactant/intermediate; Processing into formulation, mixture or 
reaction product in cleaning and vapor degreasing products; 
Processing into formulation, mixture or reaction product in paint 
and coating products; Processing into formulation, mixture or 
reaction product in adhesive and sealant products; Processing by 
repackaging; Recycling; Industrial and commercial use as solvent in 
vapor degreasing; Industrial and commercial use in maskant for 
chemical milling; Industrial and commercial use as a processing aid 
in catalyst regeneration in petrochemical manufacturing; Industrial 
and commercial use in laboratory chemicals; Industrial and 
commercial use in solvent-based adhesives and sealants; Industrial 
and commercial use in dry cleaning in 3rd generation machines until 
[DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER]; Industrial and commercial use in dry cleaning and 
related spot cleaning until [DATE 10 YEARS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE FEDERAL REGISTER]; and Disposal.

    The intention of downstream notification is to spread awareness 
throughout the supply chain of the restrictions on PCE under TSCA as 
well as provide information to commercial end users about allowable 
uses of PCE.
    To provide adequate time to update the SDS and ensure that all 
products in the supply chain include the revised SDS, EPA is proposing 
a 2-month period for manufacturers and a 6-month period for processors 
and distributers to implement the proposed SDS changes following 
publication of the final rule.
    EPA requests comments on the appropriateness of identified 
compliance timeframes for recordkeeping and downstream notification 
requirements described in this unit.
5. TSCA Section 6(g) Exemptions
    Under TSCA section 6(g)(1), EPA may grant an exemption from a 
requirement of a TSCA section 6(a) rule for a specific condition of use 
of a chemical substance or mixture if EPA makes one of three findings 
required by the statute. TSCA section 6(g)(1)(A) permits such an 
exemption if EPA finds that the specific condition of use is a critical 
or essential use for which no technically and economically feasible 
safer alternative is available, taking into consideration hazard and 
exposure. TSCA section 6(g)(1)(B) permits such an exemption if EPA 
finds that compliance with the requirement, as applied with respect to 
the specific condition of use, would significantly disrupt the national 
economy, national security, or critical infrastructure. Finally, TSCA 
section 6(g)(1)(C) allows for an exemption if EPA finds that the 
specific condition of use of the chemical substance or mixture, as 
compared to reasonably available alternatives, provides a substantial 
benefit to health, the environment, or public safety.
    TSCA section 6(g)(2) requires EPA to analyze the need for the 
exemption, and to make public the analysis and a statement on how the 
analysis was taken into account when proposing an exemption under TSCA 
section 6(g). Based on discussions with and information provided by the 
National Aeronautics and Space Administration (NASA), EPA has analyzed 
the need for an exemption for certain uses of PCE in an emergency in 
the furtherance of NASA's mission and is proposing to grant it. This 
unit presents the results of that analysis.
    Pursuant to TSCA section 6(g)(3), if an exemption is finalized, EPA 
may by rule later extend, modify, or eliminate the exemption, on the 
basis of reasonably available information and after adequate public 
justification, if EPA determines the exemption warrants a change. EPA 
will initiate this rulemaking process at the request of any regulated 
entity benefiting from such an exemption. The Agency is open to 
engagement throughout the duration of any 6(g) exemption, and 
emphasizes that to ensure continuity in the event of an extension or 
modification, such a request should come at least 2 years prior to the 
expiration of an exemption.
a. Analysis of the Need for TSCA Section 6(g)(1)(A) Exemption for 
Certain NASA Uses in an Emergency for Which no Technically or 
Economically Feasible Safer Alternative is Available
    EPA considered a TSCA section 6(g) exemption for emergency use of 
PCE in the furtherance of NASA's mission. For certain specific 
conditions of use, EPA proposes that use of PCE by NASA and its 
contractors in an emergency be exempt from the requirements of this 
rule because it is a critical or essential use provided that (1) there 
is an emergency; and (2) NASA selected PCE because there are no 
technically and economically feasible safer alternatives available 
during the emergency.
    NASA operates on the leading edge of science seeking innovative 
solutions to future problems where even small volumes of an otherwise 
prohibited chemical substance could be vital to crew safety and mission 
success. During interagency review, NASA expressed concerns that there 
will likely be circumstances where a specific, EPA-prohibited condition 
of use may be identified by NASA during an emergency as being needed in 
order to avoid or reduce situations of harm or immediate danger to 
human health, or the environment, or avoid imperiling NASA space 
missions. In such cases, it is possible that no technically and 
economically feasible safer alternative would be available that meets 
the stringent technical performance requirements necessary to remedy 
harm or avert danger to human health, the environment, or avoid 
imperiling NASA space missions.
    An emergency is a serious and sudden situation requiring immediate 
action to remedy harm or avert danger to human health, the environment, 
or to avoid imperiling NASA space missions. In NASA's case, there may 
be instances where the emergency use of PCE for specific conditions of 
use is critical or essential to remedying harm or averting danger to 
human health, the environment, or avoiding imperiling NASA space 
missions. Because of the

[[Page 39682]]

immediate and unpredictable nature of emergencies described in this 
unit and of the less forgiving environments NASA operates in that offer 
little to no margin for error, it is likely that, at the time of 
finalization of this proposal, alternatives to emergency PCE use may 
not be available in a timely manner to avoid or reduce harm or 
immediate danger (Ref. 48). In this way, these emergencies for 
particular conditions of use meet the criteria for an exemption under 
TSCA section 6(g)(1)(A), because the emergency use of PCE for listed 
conditions of use is critical or essential and no technically and 
economically feasible safer alternative will be available in a timely 
manner, taking into consideration hazard and exposure.
    In support of the TSCA section 6(g)(1)(A) emergency use exemption, 
NASA submitted detailed criteria which they must use to screen, 
qualify, and implement materials to be used in spacecraft equipment, as 
well as historical case studies that outline the loss of life and loss 
of assets in the discharge of previous missions. In one of several 
examples detailed, the Apollo I command module fire that claimed the 
lives of three American astronauts demonstrated the need for careful 
testing and continuity of materials (Ref. 48). Moreover, due to NASA's 
rigorous safety testing requirements under various environmental 
conditions, technically and economically feasible safer alternatives 
may not be readily available during emergencies and may require certain 
conditions of use of PCE to alleviate the emergency.
    In another example, NASA identified a scenario concerning a mission 
to the International Space Station (ISS) whereby, during a launch 
evolution, the countdown was paused immediately prior to launch (T-2 
minutes). NASA engineers identified a clogged filter and supply line as 
the primary issue, which required immediate attention (i.e., line 
flushing and filter cleaning). In this type of emergency scenario, an 
already approved chemical substance rated for space system applications 
is necessary to immediately remedy the situation. Although PCE was not 
used in this particular incident, if it were needed, in the future to 
address such an emergency, then the proposed exemption would allow for 
its lawful use--the countdown would resume and the launch would occur. 
Conversely, without an exemption under the specific condition of use 
(e.g., industrial and commercial use in wipe cleaning), NASA's use of 
PCE would be otherwise prohibited, which would put NASA in an untenable 
position of having to choose to either violate the law or place the 
mission (and potentially the health and safety of its employees 
involved in the mission) at risk.
    The identification and qualification of compatible materials in the 
context of aviation is iterative and involves expansive collaboration 
between original equipment manufacturers, federal agencies, and 
qualifying institutions. This is equally, if not more so, the case in 
the context of human space flight operations undertaken by NASA (Ref. 
48). NASA's mission architecture requirements often are developed many 
years in advance of an actual launch occurring. As part of mission 
planning, space systems are designed, full scale mock-ups are built, 
and mission critical hardware is constructed using materials qualified 
for spaceflight. Once NASA's mission architecture requirements are 
developed, NASA may need to retain emergency access to PCE because its 
alternatives may not have yet gone through NASA's rigorous 
certification process before their use. Allowing NASA to retain 
emergency use of PCE would reduce the chances that this rulemaking will 
hinder future space missions for which mission architecture 
infrastructure is being developed or is already built. While NASA 
considers alternatives to the chemical substances it currently uses in 
its space system designs, NASA has not yet identified technically and 
economically feasible alternatives to proven chemistries in many 
current applications. While EPA acknowledges that the use of PCE in 
emergency situations may be necessary in the near term, it is also 
EPA's understanding that NASA will continue its work to identify and 
qualify alternatives to PCE. Thus, EPA is proposing an exemption 
duration of 10 years.
b. Proposed Exemption for Certain Emergency Uses of PCE in the Context 
of Human Space Flight
    For the reasons discussed in this Unit, EPA is proposing a 10-year 
exemption for emergency use of PCE in furtherance of NASA's mission for 
the following specific conditions of use: Industrial and commercial use 
as solvent for cold cleaning; Industrial and commercial use in wipe 
cleaning. EPA is also proposing to include additional requirements as 
part of the exemption, pursuant to TSCA section 6(g)(4), including 
required notification and controls for exposure, to the extent 
feasible: (1) NASA and its contractors must provide notice to the EPA 
Administrator of each instance of emergency use within 15 days and; (2) 
NASA and its contractors would have to comply with the WCPP described 
in Unit IV.A.2 to the extent feasible.
    EPA is proposing to require that NASA notify EPA within 15 days of 
the emergency use. The notification would include a description of the 
specific use of PCE in the context of one of the conditions of use for 
which this exemption is being proposed, an explanation of why the use 
described qualifies as an emergency, and an explanation with regard to 
the lack of availability of technically and economically feasible 
alternatives.
    EPA expects NASA and its contractors have the ability to implement 
a WCPP as described in Unit IV.A.2. for the identified uses in the 
context of an emergency, to some extent even if not to the full extent 
of WCPP implementation. Therefore, EPA is proposing to require that 
during emergency use, NASA must comply with the WCPP to the extent 
technically feasible in light of the particular emergency. Under the 
proposed exemption, NASA and its contractors would still be subject to 
the proposed general recordkeeping requirements discussed in Unit 
IV.A.4.
    EPA requests comment on this TSCA section 6(g) exemption for 
continued emergency use of PCE in the furtherance of NASA's mission as 
described in this unit, and whether any additional conditions of use 
should be included, in particular for any uses qualified for space 
flight for which no technically and economically feasible safer 
alternative is available. Additionally, EPA requests comment on what 
would constitute sufficient justification of an emergency.

B. Alternative Regulatory Actions

    As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA 
must consider and publish a statement based on reasonably available 
information with respect to the reasonably ascertainable economic 
consequences of the rule, including consideration of the costs and 
benefits and the cost effectiveness of the proposed regulatory action 
and one or more primary alternative regulatory actions considered by 
the Agency. This unit includes a description of the primary alternative 
regulatory action and the second alternative regulatory action 
considered by the Agency. An overview of the proposed regulatory action 
and two alternative regulatory actions for each condition of use is in 
Unit IV.C.
1. Primary Alternative Regulatory Action Considered
    The primary alternative regulatory action described in this 
document and

[[Page 39683]]

considered by EPA combines prohibitions, requirements for a WCPP, and 
prescriptive controls to address the unreasonable risk from PCE driven 
by the various conditions of use. While in some ways it is similar to 
the proposed regulatory action, the primary alternative regulatory 
action described in this document differs from the proposed regulatory 
action by providing for a WCPP, including requirements to meet an ECEL 
or DDCC, for some conditions of use that would be prohibited under the 
proposed regulatory action. The primary alternative regulatory action 
also considers 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. The primary 
alternative regulatory action additionally includes longer compliance 
timeframes for prohibitions and implementation of WCPP and prescriptive 
controls, as described in this unit. EPA requests comment on this 
primary alternative regulatory action and whether any elements of this 
primary alternative regulatory action described in this unit should be 
considered as EPA develops the final regulatory action. EPA is 
requesting comment on whether to consider a regulatory alternative that 
would subject more conditions of use to a WCPP, instead of prohibition, 
than those currently contemplated in the primary alternative regulatory 
action. EPA also requests 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 also requests comment 
on any advantages or drawbacks for the timelines outlined in this unit 
compared to the timelines identified for the proposed regulatory action 
in Unit IV.A.
a. Prohibitions
    The primary alternative regulatory action considered by EPA would 
prohibit the manufacturing, processing, distribution in commerce, and 
use for the following industrial and commercial uses, which EPA is also 
proposing to prohibit as part of the proposed regulatory action: 
industrial and commercial use as solvent for cold cleaning; industrial 
and commercial use in other textile processing; industrial and 
commercial use in wood furniture manufacturing; industrial and 
commercial use as a solvent for aerosol lubricants; industrial and 
commercial use in wipe cleaning; industrial and commercial use in other 
spot cleaning and spot removers, including carpet cleaning; industrial 
and commercial use in automotive care products (e.g., engine degreaser 
and brake cleaner); industrial and commercial use in non-aerosol 
cleaner; industrial and commercial use in metal (e.g., stainless steel) 
and stone polishes; industrial and commercial use in foundry 
applications; industrial and commercial use as a solvent for 
penetrating lubricants and cutting tool coolants; industrial and 
commercial use in welding; industrial and commercial use for mold 
release; commercial use for photographic film; commercial use in inks 
and ink removal products (based on printing); commercial use in inks 
and ink removal products (based on photocopying); and commercial use in 
metal mold cleaning, release and protectant products. Additionally, the 
primary alternative regulatory action would prohibit the manufacture, 
processing, and distribution of PCE for consumer use. As shown in Unit 
IV.C., which presents an overview of the proposed regulatory action and 
two alternative regulatory actions for each condition of use, the 
primary alternative action described in this document would prohibit 
fewer occupational conditions of use than the proposed regulatory 
action.
    Regarding compliance timeframes, the primary alternative regulatory 
action would include longer timeframes for implementation of the 
prohibitions than the proposed regulatory action. Under the primary 
alternative action, the prohibitions would generally take effect 6 
months later than in the proposed regulatory action. Under a compliance 
timeframe that is 6 months longer than the proposed regulatory action, 
the prohibitions for the manufacturing, processing, distribution in 
commerce, and use of PCE for certain occupational conditions of use 
described in this unit would take effect 18 months for manufacturers, 
21 months for processers, 24 months for distributing to retailers, 27 
months for all other distributors (including retailers), and 30 months 
for industrial and commercial uses after the publication date of the 
final rule. With regard to the compliance timeframe for the 
manufacturing, processing, and distribution in commerce for consumer 
use (other than consumer use of clothing and articles that have been 
commercially dry cleaned with PCE), under the primary alternative 
regulatory action, prohibitions described in this unit would take 
effect in 18 months for manufacturers, 21 months for processors, 24 
months for distributing to retailers, and 27 months for all other 
distributors (including retailers) after the publication date of the 
final rule.
    Like the proposed action, the primary alternative regulatory action 
would also phaseout the manufacturing, processing, distribution in 
commerce, and commercial use of PCE for dry cleaning and spot cleaning, 
including in 3rd generation (dry-to-dry machines with refrigerated 
condenser) and 4th/5th generation (dry-to-dry machines with 
refrigerated condenser and carbon adsorber process controls) machines. 
However, the timeframes for the phaseout differ between the proposed 
action and the primary alternative action, described later in this 
unit. As described in Unit IV.A.3., a prohibition on these conditions 
of use would address the unreasonable risk driven by the following 
uses: industrial and commercial use in dry cleaning and spot cleaning 
post-2006 dry cleaning; industrial and commercial use in dry cleaning 
and spot cleaning 4th/5th generation only dry cleaning; and consumer 
use in dry cleaning solvent.
    With regards to the prohibition of dry cleaning conditions of use, 
under the primary alternative regulatory action, the following phaseout 
timeline would take effect after the publication date of the final 
rule: prohibition on the use of PCE in dry cleaning machines acquired 
12 months after the publication date of the final rule; a prohibition 
on the use of PCE in 3rd generation machines 5 years after the 
publication date of the final rule; a prohibition on the use of PCE in 
dry cleaning and spot cleaning 15 years after the publication date of 
the final rule; and a prohibition on the manufacturing, processing, and 
distribution in commerce of PCE for use in dry cleaning solvent 15 
years after the publication date of the final rule.
b. Workplace Chemical Protection Program (WCPP)
    The primary alternative regulatory action described in this 
document would require a WCPP, including requirements to meet an ECEL 
and DDCC, for the following conditions of use: industrial and 
commercial use in laboratory chemicals; processing into formulation, 
mixture, or reaction product in other chemical products and 
preparations; industrial and commercial use as a processing aid in 
pesticide, fertilizer and other agricultural chemical manufacturing; 
industrial and commercial use in specialty DOD uses (oil analysis and 
water pipe repair); industrial and commercial use in solvent-based 
paints and coatings; and industrial and commercial use as

[[Page 39684]]

solvent for aerosol spray degreaser/cleaner. As described in Unit V.A., 
uncertainties regarding (i) 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, (ii) availability of alternatives, or (iii) whether the use 
is ongoing or phased out led EPA to propose that most of these 
conditions of use be prohibited. EPA does not have sufficient 
information to confidently conclude that these conditions of use can 
meet requirements of a WCPP for PCE. Therefore, EPA requests comment on 
the ways in which PCE may be used in these conditions of use, including 
whether activities may take place in a closed system and the degree to 
which users of PCE in these sectors could successfully implement an 
ECEL, DDCC, and ancillary requirements described in Unit IV.A. For the 
industrial and commercial use in laboratory chemicals, EPA is 
soliciting comment on non-prescriptive requirements of an ECEL and DDCC 
as compared to the prescriptive workplace controls of fume hood and 
dermal PPE EPA is proposing in Unit IV.A.3.
    As with the compliance timeframes considered as part of the primary 
alternative action for prohibition, the primary alternative regulatory 
action also includes longer compliance timeframes for implementation of 
a PCE WCPP. Under the primary alternative action, the requirements for 
the WCPP would take effect 6 months later than in the proposed 
regulatory action. Under a compliance timeframe that is 6 months longer 
than the proposed regulatory action, the requirements for owners and 
operators to conduct initial baseline monitoring would take effect 12 
months after the date of publication of the final rule in the Federal 
Register. The requirements for each owner or operator to provide 
respiratory protection to all potentially exposed persons in the 
regulated area would be within 3 months after receipt of the results of 
any exposure monitoring or within 15 months after date of publication 
of the final rule in the Federal Register. Regulated entities would be 
required to implement an exposure control plan within 18 months after 
date of publication of the final rule in the Federal Register. EPA 
requests comment on any advantages or drawbacks for the timelines 
outlined in this unit compared to the timelines identified for the 
proposed regulatory action in Unit IV.A.
c. Prescriptive Controls
    The primary alternative regulatory action described in this 
document would require prescriptive workplace PPE controls for the 
following conditions of use (which are all conditions of use for which 
EPA is proposing WCPP as part of the proposed regulatory action): 
manufacturing (domestic manufacturing); manufacturing (import); 
processing as a reactant/intermediate; processing into formulation, 
mixture or reaction product in cleaning and degreasing products; 
processing into formulation, mixture or reaction products in paint and 
coating products; processing into formulation, mixture, or reaction 
product in adhesive and sealant products; processing by repackaging; 
recycling; industrial and commercial use as a solvent for open-top 
batch vapor degreaser; industrial and commercial use as solvent for 
closed-loop batch vapor degreasing; industrial and commercial use as 
solvent for in-line conveyorized vapor degreasing; industrial and 
commercial use as solvent for in-line web cleaner vapor degreaser; 
industrial and commercial use in maskant for chemical milling; and 
industrial and commercial use as processing aid in catalyst 
regeneration in petrochemical manufacturing; and disposal. 
Additionally, the primary alternative regulatory action described in 
this document would require a concentration limit for the industrial 
and commercial use in solvent-based adhesives and sealants.
    i. Prescriptive controls--PPE. In the 2020 Risk Evaluation for PCE, 
EPA identified gloves that would reduce dermal exposures to PCE. Under 
the primary alternative regulatory action, EPA considered requiring 
dermal PPE as described in Unit IV.A.2.c. This approach differs from 
the proposed regulatory action because it does not require the use of 
elimination, substitution, engineering controls and administrative 
controls or work practices, in accordance with the hierarchy of 
controls, to the extent feasible as a means of controlling dermal 
exposures to comply with the DDCC. Rather, this approach would require 
dermal PPE and training to prevent direct dermal contact with PCE as 
described in Unit IV.A.2.c.iv. EPA is soliciting comment on prescribing 
specific dermal PPE, such as gloves, for each condition of use that 
should be considered as EPA develops the final regulatory action.
    For inhalation exposures in the 2020 Risk Evaluation for PCE, EPA 
identified APFs for respirators that would mitigate the unreasonable 
risk for the conditions of use. However, as described in Unit V.A., EPA 
has uncertainty that the respirator APF identified in the 2020 Risk 
Evaluation for PCE for each condition of use is appropriate for the 
wide variety of workplaces that may be engaged in each condition of 
use, as each workplace has unique characteristics that impact PCE air 
concentration levels. For example, EPA expects that some users may 
already have existing controls in place that reduce PCE air 
concentration levels below the ECEL (Refs. 49, 50), whereas other users 
of the same condition of use have different workplace controls that 
result in air concentration levels above the ECEL. Under the primary 
alternative regulatory action, EPA considered setting minimum 
respiratory PPE requirements based on an entity's measured air 
concentration and the level of PPE needed to reduce exposures to the 
ECEL, as described in Units IV.A.2.d.i. This approach differs from the 
proposed regulatory action because it does not require the use of 
elimination, substitution, engineering controls and administrative 
controls or work practices, in accordance with the hierarchy of 
controls, to the extent feasible as a means of controlling inhalation 
exposures to comply with the ECEL. Rather, this approach would require 
respirators where inhalation exposures exceed the ECEL based on 
exposure monitoring. In addition to minimum respiratory PPE 
requirements, the primary alternative regulatory action would require 
initial monitoring within 12 months after publication of the final rule 
and periodic monitoring once every five years to determine the 
respiratory protection needed as described in Unit IV.A.2. as well as 
establishment of a regulated area as described in Unit IV.A.2., 
establishment of PPE program as described in Unit IV.A.2. and 
notification of monitoring results as described in Unit IV.A.2., with 
modifications to not require implementation of all feasible exposure 
controls according to the hierarchy of controls. EPA is soliciting 
comment on prescribing specific respirators or APFs for respirators for 
each condition of use that should be considered as EPA develops the 
final regulatory action.
    EPA understands that many workplaces already have engineering 
controls or administrative controls in place that reduce exposures to 
PCE, in particular highly standardized and industrialized workplaces or 
where PCE is used in a closed system. However, EPA does not have 
reasonably available information on engineering controls and

[[Page 39685]]

administrative controls that would mitigate unreasonable risk across a 
wide variety of workplaces for most occupational conditions of use. EPA 
is requesting comment on specific controls that mitigate the 
unreasonable risk from PCE and that could be included as part of a 
prescriptive workplace controls requirement, which could be considered 
as EPA develops the final regulatory action. Specifically, EPA is 
soliciting comment on combinations of specific engineering controls, 
administrative controls, and PPE that would reduce inhalation exposures 
to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct 
dermal contact with PCE for all workplaces where such controls would be 
required. Examples of controls and workplace practices include a vapor 
recovery system (e.g., carbon adsorption system or condenser), enclosed 
transfer liquid lines (with purging mechanisms in place (e.g., 
nitrogen, aqueous), equipment such as portable scrubber units to 
minimize vapor, ventilation units that mitigate vapor escape, and 
limiting frequency and duration of exposure to PCE. For vapor 
degreasing, EPA understands that the European Union and Germany have 
established requirements for reducing emissions of volatile organic 
compounds, such as the Solvent Emissions Directive and the German 2 
BlmSchV standard for use of chlorinated hydrocarbons in surface 
cleaning. EPA is soliciting comment on the extent to which such 
requirements could reduce inhalation exposures to at or below the ECEL 
of 0.14 ppm as an 8-hour TWA.
    As with the compliance timeframes considered as part of the primary 
alternative action for prohibition and WCPP, the primary alternative 
regulatory action includes longer compliance timeframes for 
implementation of prescriptive PPE controls. Under the primary 
alternative action, the requirements for prescriptive controls would 
take effect 6 months later than in the proposed regulatory action. 
Under a compliance timeframe that is 6 months longer than the proposed 
regulatory action, the requirements for owners and operators to provide 
dermal PPE and training would take effect 18 months after the 
publication date of the final rule. For respirator selection and 
demarcating a regulated area, the requirements for owners and operators 
to conduct initial baseline monitoring would take effect 12 months 
after the date of publication of the final rule and requirements to 
provide a respirator and demarcate a regulated area would take effect 
18 months after the publication date of the final rule. EPA is 
requesting comment on the compliance timeframe needed to implement 
engineering controls, administrative controls, and PPE that reduce 
inhalation exposures to at or below the ECEL of 0.14 ppm as an 8-hour 
TWA or prevent direct dermal contact with PCE for all regulated 
entities.
    ii. Prescriptive controls--concentration limit. To reduce exposures 
in the workplace and address the unreasonable risk of injury to health 
from PCE for the industrial and commercial use in solvent-based 
adhesives and sealants, EPA considered setting a concentration limit of 
PCE in adhesive and sealant products. The primary alternative 
regulatory action described in this document would limit the 
concentration of PCE in adhesive and sealant products to 1% by weight. 
Any percentage of PCE greater than 1% by weight would be prohibited for 
the industrial and commercial use of solvent-based adhesive and 
sealants products. Additionally, the primary alternative regulatory 
action would prohibit the import, processing, and distribution in 
commerce of adhesive and sealant products containing PCE at 
concentrations greater than 1% by weight. EPA has uncertainty that a 
concentration limit would reduce inhalation exposures such that PCE no 
longer presents an unreasonable risk, and therefore did not propose a 
concentration limit as the preferred option, as described in this Unit.
    In the 2020 Risk Evaluation for PCE, EPA identified adhesive and 
sealant products containing PCE at concentrations ranging from as low 
as 0.1% PCE by weight to as high as 100% PCE by weight, including 
several industrial adhesive products with concentrations of PCE below 
1% by weight. In considering a concentration limit as a regulatory 
action to address the unreasonable risk from inhalation and dermal 
exposures for the industrial and commercial use of solvent-based 
adhesives and sealants, EPA reviewed the dermal exposure modeling in 
the 2020 Risk Evaluation for PCE and conducted additional analysis of 
inhalation exposure data for adhesive products containing PCE below 1% 
PCE by weight (Ref. 51). Based on the dermal exposure modeling in the 
2020 Risk Evaluation for PCE, EPA determined that limiting the 
concentration of PCE in adhesive and sealant products to 1% would 
address the unreasonable risk resulting from dermal exposures (Ref. 
52). In additional analysis of inhalation exposure data for adhesives 
in support of risk management, EPA estimated inhalation exposures to 
PCE from adhesives containing PCE at concentrations ranging from 0.1% 
to 0.9% using four different approaches. In the analysis, inhalation 
exposure estimates for central tendency in all four approaches resulted 
in exposures below the ECEL. However, high-end exposure estimates 
varied across the four approaches, with two approaches resulting in 
high-end exposure estimates below the ECEL and two approaches resulting 
in high-end exposure estimates above the ECEL.
    The inhalation exposure estimates provided in the additional 
inhalation analysis are a result of several key assumptions and 
uncertainties, as described in the memo (Ref. 51). EPA therefore has 
uncertainties regarding whether a concentration limit of 1% PCE in 
adhesives and sealants would address the unreasonable risk resulting 
from inhalation exposures in occupational settings. Therefore, EPA is 
requesting comment on a combination of the 1% concentration limit for 
adhesives and sealants with specific engineering controls, 
administrative controls, or respiratory protection that would reduce 
inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-
hour TWA. Additionally, EPA is requesting comment on a combination of a 
concentration limit with WCPP requirements as described in Unit IV.A.2. 
EPA also requests monitoring data, formulations used, and detailed 
descriptions of PCE involving activities for the industrial and 
commercial use in solvent-based adhesives and sealants to determine 
whether a concentration limit would reduce inhalation exposures such 
that risks are no longer unreasonable.
    As part of the primary alternative regulatory action, the 
concentration limit of 1% by weight of PCE for adhesive and sealant 
products would only be for products intended for industrial and 
commercial use. As described in Unit IV.B.1.a., the primary alternative 
regulatory action would prohibit the manufacture, processing, and 
distribution of PCE for consumer use, including consumer use in 
adhesives for arts and crafts (including industrial adhesive, arts and 
crafts adhesive, gun ammunition sealant, livestock grooming adhesive, 
column adhesive, caulk and sealant). EPA examined the Consumer Exposure 
Model for the 2020 Risk Evaluation for PCE and found that, when 
adjusting parameters for product mass and duration of use to the 
highest values based on consumer product data in the 2020 Risk 
Evaluation for PCE for consumer adhesive conditions of use, limiting 
the concentration of PCE to 1% by weight in consumer use of products

[[Page 39686]]

would not eliminate the unreasonable risk from PCE resulting from 
inhalation and dermal exposures (Ref. 53).
    Regarding compliance timeframes under the primary alternative 
action, the prohibitions for the import, processing, distribution in 
commerce, and use of adhesive and sealant products containing PCE at 
concentrations greater than 1% by weight described in this unit would 
take effect 18 months for importers, 21 months for processers, 24 
months for distributing to retailers, 27 months for all other 
distributors (including retailers), and 30 months for industrial and 
commercial uses after the publication date of the final rule.
2. Second Alternative Regulatory Action Considered
    The second alternative regulatory action, as with the proposed 
regulatory action and the primary alternative regulatory action, is a 
combination of prohibition and a WCPP to address the unreasonable risk 
from PCE driven by the various conditions of use. While in most ways it 
is similar to the proposed regulatory action, the second alternative 
regulatory action differs from the proposed regulatory action by 
prohibiting some conditions of use that would have requirements for a 
WCPP under the proposed regulatory action. Additionally, the second 
alternative regulatory action proposes a TSCA section 6(g) time-limited 
exemption from prohibition for the industrial and commercial use of PCE 
as maskant for chemical milling and the industrial and commercial use 
of PCE for vapor degreasing. The second alternative regulatory action 
also includes shorter compliance timeframes for prohibitions and a 
WCPP, as described in this unit. EPA requests comment on this second 
alternative regulatory action and whether any elements of this second 
alternative regulatory action described in this unit should be 
considered as EPA develops the final regulatory action. EPA also 
requests comment on any advantages or drawbacks for the timelines 
outlined in this unit compared to the timelines identified for the 
proposed regulatory action in Unit IV.A.
a. Prohibitions
    The second alternative action would prohibit more occupational 
conditions of use than the proposed regulatory action. In addition to 
the conditions of use that EPA is proposing to prohibit in the proposed 
regulatory action, the second alternative regulatory action described 
in this action would also prohibit the following conditions of use: 
processing into formulation, mixture or reaction product in paint and 
coating products; processing into formulation, mixture, or reaction 
product in cleaning and degreasing products; processing into 
formulation, mixture or reaction product in adhesive and sealant 
products; industrial and commercial use as solvent for open-top batch 
vapor degreasing; industrial and commercial use as solvent for closed-
loop batch vapor degreasing; industrial and commercial use as solvent 
for in-line conveyorized vapor degreasing; industrial and commercial 
use as solvent for in-line web cleaner vapor degreasing; industrial and 
commercial use in solvent-based adhesives and sealants; and industrial 
and commercial use in maskants for chemical milling. Additionally, the 
second alternative regulatory action would prohibit the manufacture, 
processing, and distribution of PCE for consumer use.
    Like the proposed action, the second alternative regulatory action 
would also prohibit the manufacturing, processing, distribution in 
commerce, and commercial use of PCE for dry cleaning and spot cleaning, 
including in 3rd generation (dry-to-dry machines with refrigerated 
condenser) and 4th/5th generation (dry-to-dry machines with 
refrigerated condenser and carbon adsorber process controls) machines. 
However, the timeframes for the phaseout differ between the proposed 
action and the second alternative action, described later in this unit. 
As described in Unit IV.A.3., a prohibition on these conditions of use 
would address the unreasonable risk driven by the following uses: 
industrial and commercial use in dry cleaning and spot cleaning post-
2006 dry cleaning; industrial and commercial use in dry cleaning and 
spot cleaning 4th/5th generation only dry cleaning; and consumer use in 
dry cleaning solvent.
    Regarding compliance timeframes, the second alternative regulatory 
action would include more stringent timeframes for implementation of 
prohibition than the proposed regulatory action. Additionally, EPA 
would not stagger the compliance dates for manufacturers, processors, 
and distributors. The prohibitions for the manufacturing, processing, 
distribution in commerce, and use for certain industrial and commercial 
uses described in this unit would take effect 12 months after the 
publication date of the final rule. With regard to the compliance 
timeframe for the manufacturing, processing, and distribution in 
commerce for consumer use, under the second alternative regulatory 
action, prohibitions described in this unit would take effect 12 months 
after the publication date of the final rule. With regard to 
prohibition of dry cleaning conditions of use, under the second 
alternative regulatory action, the following would occur: prohibition 
on the use of PCE in dry cleaning machines acquired after the effective 
date of the final rule; a prohibition on the use of PCE in 3rd 
generation machines 6 months after the publication date of the final 
rule; a prohibition on the use of PCE in dry cleaning and spot cleaning 
5 years after the publication date of the final rule; and a prohibition 
on the manufacturing, processing, and distribution in commerce of PCE 
for use in dry cleaning solvent 5 years after the publication date of 
the final rule.
b. TSCA Section 6(g) Exemptions
    Under TSCA section 6(g)(1), EPA may grant an exemption from a 
requirement of a TSCA section 6(a) rule for a specific condition of use 
of a chemical substance or mixture if EPA makes one of three findings 
required by the statute, as outlined in Unit IV.A.5. TSCA section 
6(g)(2) requires EPA to analyze the need for the exemption, and to make 
public the analysis and a statement on how the analysis was taken into 
account when proposing an exemption under TSCA section 6(g). Based on 
discussions with and information provided by industry stakeholders, 
consultation with the DOD and NASA, and Panel recommendations in the 
SBAR Panel Report (Ref. 33), EPA has analyzed the need for three 
different exemptions and would grant two if the second alternative 
regulatory action described in this document is adopted in the final 
rule. This unit presents the results of that analysis.
    i. Analysis of the need for a TSCA section 6(g)(1)(B) exemption for 
industrial and commercial use of PCE in maskant for chemical milling 
essential for national security and critical infrastructure. EPA has 
conducted an analysis of the application of this rulemaking to the 
industrial and commercial use of PCE in maskant for chemical milling 
and found that a TSCA section 6(g) exemption may be warranted if the 
second alternative regulatory action considered by EPA is adopted, in 
its entirety or in relevant part, in the final rule. Based on 
discussions with and information provided by industry stakeholders, EPA 
understands that PCE-based maskant is used in commercial and defense 
aerospace programs that are essential for national security and 
critical infrastructure (Refs. 54, 55). For example, one facility that 
comprises 85% of the U.S. market for PCE-based maskant chemical milling 
uses PCE in the Boeing fuselage manufacturing program for the 737, 747, 
767, and 777

[[Page 39687]]

and also in defense products for the Bell V-280 Valor, Boeing P-8, 
Sikorsky CH-53K, Boeing KC-46, and Northrop Grumman B-21. Based on 
information submitted by industry, the purpose of maskant in chemical 
milling is to remove excess weight of aluminum not required for 
structural integrity in commercial and defense products. This process 
is performed on aluminum aircraft ``skins,'' which are large metal 
sheets or panels. PCE is used at the beginning of the chemical milling 
process as a temporary diluent for maskant applied to aircraft skins to 
prevent chemical milling of certain areas. After application, the 
maskant cover is scribed in specific locations and dry maskant is 
pulled or removed, exposing aluminum metal, while the PCE evaporates 
and is captured into a recovery system. Information submitted by 
stakeholders notes that PCE does not remain on the airplane skins when 
the skins are etched nor at any other point after the chemical milling 
stage of fabrication.
    According to information submitted by industry, PCE-based maskant 
is required to meet certain performance requirements that other 
alternatives are unable to meet. For example, PCE-based maskant meets 
several Boeing Aircraft process specifications such as ``Chemical 
Milling Aluminum Alloys'' (BAC 5772), ``Maskant Trimming of Fatigue 
Critical Hardware'' (BAC 5986), ``Phosphoric Acid Anodizing of Aluminum 
for Structural Bonding'' (BAC 5555), and ``Appearance Control of Clad 
Aluminum Exterior Skins'' (Boeing D6-9002). These process 
specifications are mandatory for suppliers as part of the quality 
system that aircraft production certificate holders are required to 
establish under 14 CFR 21.137. Additionally, PCE-based maskant also 
meets other industry performance requirements such as Stretch Forming, 
Laser Scribe Compatible, and General Parts Protection.
    Representatives from the facility that comprises 85% of the U.S. 
market for PCE-based maskant chemical milling have described to EPA how 
efforts to develop new maskant have been ongoing for over 30 years but 
have not yet found a substitute that meets all of the necessary 
performance requirements (Ref. 54). PCE-based maskant also allows for 
solvent capture and recycling. The same company has recaptured and 
recycled more than 95% of the PCE used for more than 29 years, the 
remaining PCE being captured using special filters, mats, and non-
recoverable mediums that are disposed of by a company that specializes 
in providing environmental services for controlled chemicals (Ref. 55).
    As discussed in this unit and in the Alternatives Assessment (Ref. 
56), substitute chemicals for maskant for chemical milling may not meet 
the performance requirements of maskant needed for chemical milling of 
aluminum aircraft skins for commercial and defense purposes and thus 
may not be technically feasible as alternatives. Therefore, EPA has 
preliminarily determined that if PCE-based maskant were not available, 
or if industry cannot meet the requirements of the WCPP in the proposed 
regulatory action or of the prescriptive controls considered as the 
primary alternative regulatory action, there would be a significant 
disruption to national security and critical infrastructure. In 
addition, due to availability concerns, EPA has preliminarily 
determined that a ban on the manufacture, processing, and distribution 
in commerce of PCE-based maskant could also significantly disrupt 
national security and critical infrastructure. A prohibition on the use 
of PCE for chemical milling of aluminum aircraft skins could affect the 
ability to make available new military aircraft on schedule, and 
consequently, potentially affect DOD's capability and readiness. Such a 
prohibition would also affect the availability of new civilian aircraft 
and thus have negative impacts on civilian aviation. Aviation has been 
designated by the Department of Homeland Security as a key subsector in 
the Transportation Systems Sector, one of 16 designated critical 
infrastructure sectors.
    Based on the expected significant disruption to national security 
and critical infrastructure, a TSCA section 6(g) exemption may be 
warranted if the proposed and primary alternative regulatory actions 
are not suitable to address the unreasonable risk driven by this 
condition of use. Therefore, as part of the second alternative 
regulatory action, EPA would grant a 10-year exemption from prohibition 
for the industrial and commercial use of PCE as maskant for chemical 
milling. EPA believes that the information provided by industry on the 
time needed to identify and qualify substitutes supports a 10-year 
exemption period. Further, the industry submitter has provided 
information demonstrating that engineering controls are already in 
place to lower, to the extent possible, exposure concentrations to PCE 
and to limit occupational exposures, including supplementing with PPE 
during tasks that may result in greater exposure. Based on the 
information submitted, EPA understands that existing controls ensure 
airborne concentrations of PCE are generally kept below 1 ppm as an 8-
hour TWA (below the existing regulatory and voluntary occupational 
exposure limits described in Units II.C.4. and 5.). While EPA 
acknowledges that the airborne concentration may exceed the ECEL, the 
exemption as part of the second alternative regulatory action would 
include the following provisions to ensure that exposures are reduced 
to the lowest levels achievable:: the proposed general recordkeeping 
requirements discussed in Unit IV.A.4.i., documentation of the 
engineering controls and PPE used to reduce potentially exposed 
persons' exposure to the extent possible, and records that demonstrate 
compliance with the exemption conditions, including the condition that 
PCE only be used for chemical milling of aluminum aircraft skins.
    EPA requests comments on all aspects of the section 6(g) exemption 
from the prohibition on industrial and commercial use of PCE in maskant 
for chemical milling as part of the second alternative regulatory 
option, including information on the extent to which this industry 
could meet the requirements of the proposed WCPP or prescriptive 
controls, whether compliance with specific elements of the proposed 
WCPP should also be required during the period of the exemption, and 
the time period of the exemption pursuant to TSCA section 6(g)(3).
    ii. Analysis of the need for a TSCA section 6(g)(1)(B) exemption 
for industrial and commercial use of PCE in vapor degreasing essential 
for national security and critical infrastructure. EPA has conducted an 
analysis of the application of this rulemaking to the industrial and 
commercial use of PCE in vapor degreasing and found that a TSCA section 
6(g) exemption may be warranted if the second alternative regulatory 
action considered by EPA is adopted, in its entirety or in relevant 
part, in the final rule. EPA received a request for a section 6(g) 
exemption from prohibition for the use of PCE in vapor degreasing of 
aerospace parts from a manufacturer of commercial jetliners and 
defense, space, and security systems (Refs. 57, 58). The aerospace 
parts have commercial, DOD, and NASA uses (Ref. 59); as the requester 
describes, they manufacture and procure these parts and have identified 
that PCE vapor degreasing is necessary due to technical challenges with 
other alternative substitute chemicals or methods.
    The requester has spent many years developing, qualifying, and 
implementing alternative materials and

[[Page 39688]]

processes to replace PCE vapor degreasing with aqueous cleaning where 
technically viable. According to the requester, while the transition to 
aqueous cleaning has been successful for many detail parts, there are 
technical challenges with alternative substitute chemicals and 
processes for the vast majority of complex aerospace machining parts 
and actuation systems, such as structural components, gears, and other 
parts that make up drive units and control mechanisms. The requester 
states that PCE vapor degreasing is the best cleaning method to pre-
clean most complex machining parts and actuation systems because it 
does not allow the transfer of contaminates from one part to another. 
The requester notes that, for those parts approved for aqueous 
cleaning, the parts so cleaned must be carefully segregated to avoid 
cross-contamination, which substantially increases the required 
processing time.
    The requester notes that an adequate transition period for this 
technically challenging aerospace use requires substantial investment 
and time to develop viable alternatives. The requester is currently in 
the process of identifying a replacement solvent that can adequately 
clean, cause no harm to parts, and is not an equally toxic material to 
PCE. Based on the submitted request, conversion from vapor degreasing 
to aqueous cleaning is a capital-intensive investment that the 
requester expects would require several years to plan, permit, 
construct, and install. Additionally, the requester notes that the 
aerospace industry needs to ensure that aerospace parts meet DOD and 
other Federal Aviation Administration (FAA) specifications to ensure 
safety of flight. For example, in order to replace the chemical with an 
alternative, the requester notes that they must identify, test, and 
select an alternative that meets technical requirements derived from 
FAA mandated standards for a typical part used in a commercial 
aircraft, such as specifications for specific gravity (ASTM D 792), 
Water Absorption (ASTM D 750), and other test requirements, which may 
be a lengthy process (Ref. 60). According to the information submitted, 
certification with FAA could take at least nine months for individual 
parts of components or up to several years for major subsystems or 
complete aircraft (Ref. 60). The requester also notes that while they 
do not know the extent that their supply chain has transitioned away 
from use of PCE in vapor degreasing, PCE has been used in vapor 
degreasing to meet required levels of cleanliness of certain supplied 
parts by long-standing design specifications that are incorporated into 
contracts of a complex supply chain. The requester also told EPA the 
suppliers are not required to inform the requester of the process they 
use to clean parts that the supplier provides to the requester, and the 
requester therefore may not know which solvent a supplier has selected 
for vapor degreasing or what factors were considered when selecting 
cleaning systems. According to the requester, material declarations and 
auditing processes to validate usage may be burdensome, considering 
that a large portion of the requester's supply chain includes small 
suppliers. Due to the concerns raised with transitioning to aqueous 
cleaning or another new cleaning method, the requester has requested 
that EPA exempt use of PCE in vapor degreasing of aerospace parts for 
10 years.
    As discussed in this unit, information submitted by the requester 
indicates that substitute chemicals for vapor degreasing of aerospace 
parts may not be technically feasible at this time for meeting the 
cleanliness standards of certain parts as required by DOD and FAA 
specifications or other specifications included in existing contracts 
within the supply chain. According to the requester, more time is 
needed for companies to make the capital-intensive transition from PCE 
vapor degreasing to aqueous cleaning for those parts that can be 
cleaned using the aqueous method. In addition, the requester states 
that they are continuing to work towards identifying a replacement 
solvent that is able to adequately clean complex machining parts and 
actuation systems parts without harming them, and that is not a 
regrettable substitution. Therefore, EPA has preliminarily determined 
that if the use of PCE for vapor degreasing were not available in the 
near term for aerospace parts, or if industry could not meet the 
requirements of the WCPP as proposed or of the prescriptive controls 
considered as the primary alternative regulatory action, compliance 
with such requirements would significantly disrupt national security 
and critical infrastructure. In addition, due to availability concerns, 
EPA has preliminarily determined that a ban on the manufacture, 
processing, and distribution in commerce of PCE for vapor degreasing of 
aerospace parts could also significantly disrupt national security and 
critical infrastructure. A prohibition on the use of PCE for vapor 
degreasing of aerospace parts in the near term could negatively affect 
DOD's capability and readiness, which includes the ability to 
adequately maintain aircraft. Such a prohibition could also negatively 
affect the maintenance of civilian aircraft and potentially have 
impacts on the safety of civilian flight.
    For the reasons discussed in this unit, EPA would grant a 10-year 
exemption from prohibition as part of the second alternative regulatory 
action for the industrial and commercial use of PCE in vapor degreasing 
for aerospace parts. EPA believes that the information provided by the 
requester on the time needed to identify and qualify substitutes 
supports a 10-year exemption period. Further, the requester has 
provided information demonstrating that engineering controls are in 
place to lower, to the extent possible, exposure concentrations and 
limit occupational exposures to PCE. The exemption would also include 
the following conditions: the proposed general recordkeeping 
requirements discussed in Unit IV.A.4.i., documentation of the 
engineering controls used to reduce potentially exposed persons' 
exposure, and records to demonstrate compliance with the exemption 
conditions, including the condition that PCE only be used in vapor 
degreasing for aerospace parts where other alternatives present 
technical feasibility or cleaning performance challenges to meet DOD 
and FAA specifications or other long-standing design specifications 
that are included in existing contracts.
    EPA requests comments on all aspects of the exemption request and 
proposed exemption from the prohibition on use of PCE in vapor 
degreasing as part of the second alternative regulatory action, 
including information on the extent to which this industry could meet 
the requirements of the proposed WCPP or prescriptive controls and 
whether compliance with specific elements of the proposed WCPP should 
also be required during the period of the exemption. EPA is requesting 
comment on whether vapor degreasing of parts and components for non-
aerospace applications should also be exempt from prohibition as part 
of the second alternative regulatory action for the industrial and 
commercial use of PCE in vapor degreasing.
    To facilitate EPA's consideration of exemptions for other sectors, 
comments in support of additional exemptions should include detailed 
explanations of why and how long exemptions would be needed. 
Additionally, EPA is soliciting comment on whether it should specify 
the type of vapor degreasing operation, such as closed-loop batch vapor 
degreasing, that would

[[Page 39689]]

be exempt from prohibition as part of the second alternative regulatory 
action for the industrial and commercial use of PCE in vapor degreasing 
for aerospace parts and whether it should consider different exemption 
timeframes for different types of vapor degreasing operations.
    iii. Analysis of the need for a TSCA section 6(g) exemption for 
industrial and commercial use of PCE in dry cleaning. Following Panel 
recommendations in the SBAR Panel Report (Ref. 33), EPA has considered 
a TSCA section 6(g) exemption for the use of PCE in dry cleaning and 
has not found that a TSCA section 6(g) exemption is warranted. As 
discussed in Units IV.A.1.c. and V.A.1., based on consideration of the 
irreversible health effects associated with PCE exposures, the 
uncertainty that this sector can comply with a WCPP and reduce 
exposures sufficiently to address the unreasonable risk, and reasonably 
available information that indicates that alternatives, such as high 
flash point hydrocarbons and wet cleaning, are available, EPA 
determined that a prohibition would be the most appropriate way to 
eliminate the identified risks that drive the unreasonable risk to 
health resulting from the following conditions of use: industrial and 
commercial use in dry cleaning and spot cleaning post-2006 dry 
cleaning; industrial and commercial use in dry cleaning and spot 
cleaning 4th/5th generation only dry cleaning; and consumer use in dry 
cleaning solvent (i.e., exposure to clothing or articles recently dry 
cleaned with PCE). EPA has uncertainty regarding whether industrial and 
commercial dry cleaning and spot cleaning users can comply with the 
provisions of the WCPP, including reducing air concentration to below 
the ECEL and complying with the WCPP implementation measures such as 
periodic monitoring, a PPE program, and developing an exposure control 
plan that reduces exposures in a manner aligns with the hierarchy of 
controls where PPE is the least preferred option. This uncertainty 
includes considerations of worker tasks that may occur in open-systems 
or may require manual application or exposure to PCE or PCE-containing 
products (e.g., manual stain removal, garment unloading, or 
transferring solvent from storage container to machine that EPA 
understands are common tasks at dry cleaning facilities) and 
difficulties related to respiratory protection, as described in Unit 
V.A. Based on reasonably available information, including market 
research, existing State actions restricting the use of PCE in dry 
cleaning, and engagement with industry, trade associations, and State 
and local agencies, EPA has determined that a phaseout period of five 
to fifteen years, as is included in the proposed regulatory action and 
alternative regulatory actions, are reasonable compliance timeframes to 
allow dry cleaners time to transition away from PCE. EPA requests 
comments on all aspects of this analysis of a need for an exemption 
under TSCA section 6(g), including information on the whether the 
specific use may be critical or essential, the availability of 
technically and economically feasible safer alternatives, and the time 
needed to implement alternatives.
c. Workplace Chemical Protection Program (WCPP)
    The second alternative regulatory action considered by EPA would 
require a WCPP as described in Unit IV.A. for the following conditions 
of use: manufacturing (domestic manufacturing); manufacturing (import); 
processing as a reactant/intermediate; processing by repackaging; 
recycling; industrial and commercial use as a processing aid in 
catalyst regeneration in petrochemical manufacturing; and disposal. As 
with the proposed regulatory action, under the second alternative 
regulatory action, recycling and disposal would not be subject to the 
WCPP ECEL requirements. As with the compliance timeframes considered as 
part of the second alternative regulatory action for prohibition, the 
second alternative regulatory action also includes shorter compliance 
timeframes for implementation of the PCE WCPP than the proposed 
regulatory action. Under the second alternative action, the 
requirements for WCPP would take effect 3 months sooner than in the 
proposed regulatory action. Under a compliance timeframe that is 3 
months shorter than the proposed regulatory action, the requirements 
for owners and operators to conduct initial baseline monitoring would 
take effect 3 months after the date of publication of the final rule in 
the Federal Register. Each owner or operator would be required to 
provide respiratory protection to all potentially exposed persons in 
the regulated area within 3 months after receipt of the results of any 
exposure monitoring or within 6 months after date of publication of the 
final rule in the Federal Register. Regulated entities would be 
required to implement an exposure control plan within 9 months after 
date of publication of the final rule in the Federal Register. EPA 
requests comment on any advantages or drawbacks for the timelines 
outlined in this unit compared to the timelines identified for the 
proposed regulatory action in Unit IV.A.
d. Prescriptive Controls
    The second alternative regulatory action considered by EPA would 
require fume hood and dermal PPE for the industrial and commercial use 
as a laboratory chemical, as described in Unit IV.A.3. As with the 
compliance timeframes considered as part of the second alternative 
action for prohibition and WCPP, the second alternative regulatory 
action also includes shorter compliance timeframes for implementation 
of prescriptive controls. Under the second alternative action, the 
requirements for prescriptive controls would take effect 3 months 
sooner than in the proposed regulatory action. Under a compliance 
timeframe that is 3 months shorter than the proposed regulatory action, 
requirements that owners and operators provide dermal PPE and a fume 
hood would take effect 9 months after the publication date of the final 
rule.

C. Overview of conditions of Use and Proposed Regulatory Action and 
Alternative Regulatory Actions.

    Table 2 is a side-by-side depiction of the proposed regulatory 
action with the primary and second alternative actions for each 
condition of use identified as driving the unreasonable risk (Ref. 2). 
The purpose of this table is to succinctly convey to the public the 
major differences between the proposed regulatory action and the 
alternative regulatory actions; as such the actions in each column are 
truncated and do not reflect all the details of the proposed and 
alternative regulatory actions, including differences in timeframes. 
The proposed and alternative regulatory actions are described more 
fully in Units IV.A. and B.

[[Page 39690]]



 Table 2--Overview of Conditions of Use Driving Unreasonable Risk and Proposed Regulatory Action and Alternative
                                               Regulatory Actions
----------------------------------------------------------------------------------------------------------------
                                                                         Action
Condition of use driving unreasonable --------------------------------------------------------------------------
         risk  determination             Proposed regulatory      Primary alternative       Second alternative
                                                action                   action                   action
----------------------------------------------------------------------------------------------------------------
Industrial and commercial use as a     PCE WCPP...............  Prescriptive Controls    PCE WCPP.
 processing aid in catalyst                                      (PPE).
 regeneration in petrochemical
 manufacturing.
Industrial and commercial use in       Prescriptive Controls    PCE WCPP...............  Prescriptive Controls
 laboratory chemicals.                  (fume hood, dermal                                (fume hood, dermal
                                        PPE).                                             PPE).
Industrial and commercial use in       PCE WCPP...............  Prescriptive Controls    Prohibit.\1\
 paints and coatings in maskants for                             (PPE).
 chemical milling.
Industrial and commercial use as       PCE WCPP...............  Prescriptive Controls    Prohibit.\1\
 solvent for open-top batch vapor                                (PPE).
 degreaser.
Industrial and commercial use as       PCE WCPP...............  Prescriptive Controls    Prohibit.\1\
 solvent for closed-loop batch vapor                             (PPE).
 degreaser.
Industrial and commercial use as       PCE WCPP...............  Prescriptive Controls    Prohibit.\1\
 solvent for in-line conveyorized                                (PPE).
 vapor degreaser.
Industrial and commercial use as       PCE WCPP...............  Prescriptive Controls    Prohibit.\1\.
 solvent for in-line web cleaner                                 (PPE).
 vapor degreaser.
Industrial and commercial use as a     Prohibit...............  PCE WCPP...............  Prohibit.
 processing aid in pesticide,
 fertilizer and other agricultural
 chemical manufacturing.
Industrial and commercial use in       Prohibit...............  PCE WCPP...............  Prohibit.
 specialty DOD uses (oil analysis and
 water pipe repair).
Industrial and commercial use in       PCE WCPP...............  Prescriptive Controls    Prohibit.
 solvent-based adhesives and sealants.                           (Concentration limit).
Industrial and commercial use in       Prohibit...............  PCE WCPP...............  Prohibit.
 solvent-based paints and coatings.
Industrial and commercial use as       Prohibit...............  PCE WCPP...............  Prohibit.
 solvent for aerosol spray degreaser/
 cleaner.
Industrial and commercial use in dry   Prohibit...............  Prohibit...............  Prohibit.
 cleaning and spot cleaning post-2006
 dry cleaning.
Industrial and commercial use in dry   Prohibit...............  Prohibit...............  Prohibit.
 cleaning and spot cleaning 4th/5th
 gen only dry cleaning.
Industrial and commercial use as       Prohibit...............  Prohibit...............  Prohibit.
 solvent for cold cleaning.
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 other textile processing.
Industrial and commercial use in wood  Prohibit...............  Prohibit...............  Prohibit.
 furniture manufacturing.
Commercial use for photographic film.  Prohibit...............  Prohibit...............  Prohibit.
Industrial and commercial use as a     Prohibit...............  Prohibit...............  Prohibit.
 solvent for aerosol lubricants.
Industrial and commercial use in wipe  Prohibit...............  Prohibit...............  Prohibit.
 cleaning.
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 other spot cleaning and spot
 removers, including carpet cleaning.
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 automotive care products (e.g.,
 engine degreaser and brake cleaner).
Industrial and commercial use in non-  Prohibit...............  Prohibit...............  Prohibit.
 aerosol cleaner.
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 metal (e.g., stainless steel) and
 stone polishes.
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 foundry applications.
Commercial use in inks and ink         Prohibit...............  Prohibit...............  Prohibit.
 removal products (based on printing).
Industrial and commercial use in       Prohibit...............  Prohibit...............  Prohibit.
 welding.
Industrial and commercial use for      Prohibit...............  Prohibit...............  Prohibit.
 mold release.
Commercial use in inks and ink         Prohibit...............  Prohibit...............  Prohibit.
 removal products (based on
 photocopying).
Commercial use in metal mold           Prohibit...............  Prohibit...............  Prohibit.
 cleaning, release and protectant
 products.
Industrial and commercial use as a     Prohibit...............  Prohibit...............  Prohibit.
 solvent for penetrating lubricants
 and cutting tool coolants.
Consumer use in dry cleaning solvent.  Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
Consumer use in automotive care        Prohibit \2\...........  Prohibi \2\............  Prohibit.\2\
 products (parts cleaner).
Consumer use in lubricants and         Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 greases (lubricants and penetrating
 oils).
Consumer use in adhesives for arts     Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and crafts (including industrial
 adhesive, arts and crafts adhesive,
 gun ammunition sealant).
Consumer use in adhesives for arts     Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and crafts (livestock grooming
 adhesive).
Consumer use in adhesives for arts     Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and crafts (column adhesive, caulk
 and sealant).

[[Page 39691]]

 
Consumer use in solvent-based paints   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and coatings (coatings and primers
 (aerosol)).
Consumer use in solvent-based paints   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and coatings (metallic overglaze).
Consumer use in welding..............  Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
Consumer use in metal mold cleaning,   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 release and protectant products.
Consumer use in cleaners and           Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 degreasers (other).
Consumer use in automotive care        Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 products (brake cleaner).
Consumer use in aerosol cleaner        Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 (vandalism mark and stain remover).
Consumer use in non-aerosol cleaner    Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 (e.g., marble and stone polish).
Consumer use in lubricants and         Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 greases (cutting fluid).
Consumer use in solvent-based paints   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and coatings (outdoor water shield
 (liquid)).
Consumer use in solvent-based paints   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 and coatings (rust primer and
 sealant (liquid)).
Consumer use in metal (e.g.,           Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 stainless steel) and stone polishes.
Consumer use in inks and ink removal   Prohibit \2\...........  Prohibit \2\...........  Prohibit.\2\
 products.
Manufacturing (domestic                PCE WCPP...............  Prescriptive Controls    PCE WCPP.
 manufacturing).                                                 (PPE).
Manufacturing (import)...............  PCE WCPP...............  Prescriptive Controls    PCE WCPP.
                                                                 (PPE).
Processing as a reactant/intermediate  PCE WCPP...............  Prescriptive Controls    PCE WCPP.
                                                                 (PPE).
Processing into formulation, mixture   PCE WCPP...............  Prescriptive Controls    Prohibit.
 or reaction product in paint and                                (PPE).
 coating products.
Processing into formulation, mixture   PCE WCPP...............  Prescriptive Controls    Prohibit.
 or reaction product in cleaning and                             (PPE).
 degreasing products.
Processing into formulation, mixture   Prohibit...............  PCE WCPP...............  Prohibit.
 or reaction product in other
 chemical products and preparations.
Processing into formulation, mixture   PCE WCPP...............  Prescriptive Controls    Prohibit.
 or reaction product in adhesive and                             (PPE).
 sealant products.
Repackaging..........................  PCE WCPP...............  Prescriptive Controls    PCE WCPP.
                                                                 (PPE).
Recycling............................  PCE WCPP...............  Prescriptive Controls    PCE WCPP.
                                                                 (dermal PPE).
Disposal.............................  PCE WCPP...............  Prescriptive Controls    PCE WCPP.
                                                                 (dermal PPE).
----------------------------------------------------------------------------------------------------------------
\1\ TSCA section 6(g) exemption, including the manufacture (including import), processing, and distribution for
  this condition of use.
\2\ Prohibit manufacture (including import), processing, and distribution in commerce for the consumer use.

V. Rationale for the Proposed Regulatory Action and Alternative 
Regulatory Actions

    This unit describes how the considerations described in Unit 
III.B.3. were applied when selecting among the TSCA section 6(a) 
requirements to arrive at the proposed and alternative regulatory 
actions described in Unit IV.

A. Consideration of Risk Management Requirements Available Under TSCA 
Section 6(a)

1. Proposed Regulatory Action
a. Prohibition
    EPA considered a prohibition as a regulatory option and is 
proposing it for certain occupational conditions of use (Unit IV.A.). 
Prohibition is the preferred option for occupational conditions of use 
where greater uncertainty exists relative to a sector's ability to 
comply with provisions of the proposed PCE WCPP, such as an ECEL or 
DDCC. EPA's 8-hour TWA ECEL for PCE is significantly lower than the 
OSHA PEL and there is a degree of uncertainty as to whether chemical 
users under the conditions of use in some sectors will be able to 
comply with such a level and thus whether the unreasonable risk would 
be addressed. This uncertainty includes consideration of the 
difficulties related to respiratory protection, which are discussed in 
more detail in Unit V.A.1.b., and which include how respirators may 
present communication problems, vision problems, worker fatigue, and 
reduced work efficiency (63 FR 1152, January 8, 1998) as well as 
consideration for that fact that not all workers may be able to wear 
respirators. Similarly, there is also uncertainty regarding certain 
chemical users' ability to prevent direct dermal contact with PCE, in 
particular during use in open-systems or when worker activities require 
manual application or removal of PCE or a PCE-containing product 
through rags, aerosols, spray guns, roll applicators, fingers, hands, 
or other materials. Additionally, prohibition is the preferred option 
for occupational conditions of use where reasonably available 
information suggests minimal ongoing use or when feasible safer 
alternatives are reasonably available. The uncertainties related to 
whether users under certain conditions of use could comply with the 
requirements of a PCE WCPP, combined with the severity of the risks of 
PCE, the prevalence of alternative processes and products (Unit V.B), 
and in some cases reasonably available information indicating a use is 
no longer ongoing (Refs. 56, 3), has led EPA to propose prohibitions 
for most industrial and

[[Page 39692]]

commercial uses of PCE, as well as for the upstream manufacturing, 
processing, and distribution in commerce for those uses. EPA requests 
comment regarding the number of businesses and other entities that 
could potentially close as well as associated costs with a prohibition 
of PCE for the industrial and commercial conditions of use identified 
in Unit IV.A.1.
    As outlined in Unit IV.A.1., EPA is proposing to phase out the use 
of PCE in dry cleaning and associated spot cleaning at dry cleaning 
facilities. While EPA recognizes the exposure reductions and 
significant investments in equipment improvements made by dry cleaners, 
as described by SERs and summarized in the SBAR Panel Report (Ref. 33), 
EPA has determined that the industrial and commercial uses of PCE in 
dry cleaning and the consumer use of PCE in dry cleaning drive the 
unreasonable risk for PCE, and is proposing that prohibition is the 
most appropriate approach to eliminate the unreasonable risk. Following 
the Panel recommendations in the SBAR report (Ref. 33), EPA is 
providing an assessment on the impact of the rule on the dry cleaning 
industry in the Economic Analysis (Ref. 3), summarized here. Based on 
consultation with stakeholders, EPA understands that the use of PCE in 
dry cleaning is currently declining. Stakeholders, including State and 
Local Agencies and trade associations, have noted an overall year-to-
year decline in the use of PCE in dry cleaning and many expect PCE to 
phase out naturally or decrease to extremely low numbers as older 
machines are retired and alternative solvents are adopted (Ref. 61). As 
described more fully in the Economic Analysis, EPA assumes dry cleaning 
machines are retired 15 to 25 years after the manufactured date. 
Therefore, EPA assumes most dry cleaning machines manufactured and 
installed before 2005, such as for 3rd generation machines, would be 
beyond their projected useful life by the proposed phaseout dates 
outlined in Unit IV.A.1. Additionally, reasonably available information 
on the current use of alternatives to PCE in dry cleaning, including 
cost, effectiveness, and safety, indicate suitable alternatives are 
available (Refs. 61, 62). As described more fully in the Economic 
Analysis, EPA expects that multi-solvent or hydrocarbon dry cleaning 
machines are likely to be the most common alternatives to PCE dry 
cleaning. However, other alternatives, such as wet cleaning, are 
available (Refs. 27, 28, 29, 30, 31).
    EPA determined prohibition would not be suitable for the remaining 
occupational conditions of use, such as processing as a reactant/
intermediate and several types of processing into a formulation, 
mixture, or reaction product; and industrial and commercial uses as a 
solvent for cleaning and degreasing in vapor degreasers, particularly 
for aerospace and defense applications, in maskant for chemical 
milling, in solvent-based adhesives and sealants, as a processing aid 
in catalyst regeneration in petrochemical manufacturing, and as a 
laboratory chemical. EPA made this determination based on compelling 
reasons to not prohibit the activity and identification of a different 
regulatory action that would address the unreasonable risk. For 
example, prohibition may not be suitable for conditions of use that may 
complement the Agency's efforts to address climate-damaging HFCs under 
the AIM Act, or have national security or other significance for 
critical sectors, where EPA identified strict workplace controls could 
be implemented for these uses to address the unreasonable risk as 
described in Unit V.A.1.b. Additionally, prohibition may not be 
suitable for conditions of use where alternative substances to PCE are 
more or equally hazardous, in particular for other solvents undergoing 
risk evaluation and risk management under TSCA section 6. For example, 
for processing as a reactant/intermediate, PCE and trichloroethylene 
(TCE) are both used as feedstock in the manufacture of HFC-134a 
although they are not drop in substitutes. As another example, PCE, 
TCE, 1-bromopropane, methylene chloride, and trans-1,2-dichloroethylene 
are solvents used in vapor degreasing and have or are currently 
undergoing risk evaluation or risk management under TSCA. In selecting 
among the TSCA section 6(a) requirements for the proposed approach for 
conditions of use where alternative substances to PCE may include other 
solvents undergoing risk evaluation and risk management under TSCA 
section 6, EPA considered whether technically and economically feasible 
alternatives that benefit health or the environment will be reasonably 
available as a substitute.
    For these conditions of use, EPA determined restrictions under a 
PCE WCPP were more suitable for addressing the unreasonable risk to the 
extent necessary so that PCE no longer presents such risk, while also 
allowing flexibility for regulated entities to continue operations, as 
described in this unit and in Unit IV.A.
    Regarding industrial, commercial, and consumer uses of PCE, TSCA 
section 6(a)(2) provides EPA with the authority to prohibit or 
otherwise restrict the manufacture (including import), processing, or 
distribution in commerce of a substance or mixture ``for a particular 
use'' to ensure that a chemical substance no longer presents 
unreasonable risk. For this rule, EPA proposes that ``for a particular 
use'' includes consumer use more broadly, as well as industrial and 
commercial use, which encompasses all known, intended, and reasonably 
foreseen uses of PCE. Given the severity and ubiquitous nature of the 
risks identified in the 2020 Risk Evaluation for PCE for all 
industrial, commercial, and consumer uses evaluated, and noting that 
those conditions of use evaluated in the Risk Evaluation encompass all 
known, intended, and reasonably foreseen uses of PCE, EPA proposes that 
prohibiting manufacture (including import), processing, and 
distribution in commerce of PCE for most industrial and commercial use 
and all consumer use is reasonable and necessary to eliminate the 
unreasonable risk of PCE, including by precluding retailers from 
selling PCE and PCE-containing products to consumers. EPA believes that 
any retailer selling PCE-containing products to consumers would be 
selling products for one of the consumer uses EPA evaluated in the 2020 
Risk Evaluation for PCE and found to drive the unreasonable risk for 
PCE. Other regulatory options that would restrict the manufacture 
(including import), processing, and distribution in commerce of PCE for 
consumer use, such as setting a concentration limit, would not 
adequately address the identified unreasonable risk driven by consumer 
use. EPA's proposed requirements to address unreasonable risk to 
consumers and bystanders to consumer use are described in Unit IV.A.
    A key consideration regarding consumer use is the role of retailers 
and other distributors. A retailer, as EPA has defined in 40 CFR 
751.103 (and proposes to define in 40 CFR 751.5), is any entity that 
makes available a chemical substance or mixture to consumer end users, 
including e-commerce internet sales or distribution. Previously, in the 
2019 methylene chloride TSCA section 6(a) risk management rule 
addressing consumer use of methylene chloride in paint and coating 
removal (40 CFR part 751, subpart B), EPA prohibited retailers from 
distributing in commerce paint and coating removers containing 
methylene chloride (see 40 CFR 751.105(b) and (c)). To meet the same 
goal of protecting consumers from accessing PCE-containing products 
that

[[Page 39693]]

could pose unreasonable risk, for a broader range of consumer 
conditions of use, EPA considered and is proposing a similar provision 
to ensure that retailers will not be able to purchase PCE for sale or 
distribution to consumers and will not be able to sell or distribute 
PCE to consumers, including making available to consumers products 
containing PCE. For these reasons, as described in Unit IV.A., EPA's 
proposal to address unreasonable risk from PCE includes prohibition on 
the distribution in commerce of PCE to and by retailers.
    To support implementation of the proposed prohibitions EPA also 
considered, and is proposing, a de minimis level for products 
containing PCE to account for impurities that do not drive the 
unreasonable risk. EPA conducted an analysis using the methodology in 
the 2020 Risk Evaluation for PCE to estimate whether there is a weight 
fraction of PCE in industrial/commercial and consumer products below 
which the industrial/commercial and consumer uses of those products, 
respectively, would not drive the unreasonable risk from PCE. EPA 
examined the Consumer Exposure Model for the 2020 Risk Evaluation for 
PCE and found that, when adjusting parameters for product mass and 
duration of use to the highest values based on consumer product data in 
the 2020 Risk Evaluation for PCE, consumer use of products that are 
0.124% PCE or less by weight would not drive the unreasonable risk from 
PCE (Ref. 53). To identify a concentration limit of PCE in industrial/
commercial products that would not drive the unreasonable risk from 
PCE, EPA also conducted an analysis using the Brake Servicing Near-
Field/Far-Field exposure model in the 2020 Risk Evaluation for PCE and 
calculated that a PCE concentration of 0.7% in aerosol brake degreasing 
products would achieve exposure concentrations at or below the ECEL 
based on a near-field 8-hour TWA of 0.145 ppm at the 95th percentile 
(Ref. 45). Based on these analyses, EPA is proposing to exclude from 
prohibition products containing PCE at less than 0.1% by weight, as 
described in Unit IV.A. EPA has identified uncertainties with a 
concentration limit of 0.1% addressing the unreasonable risk. For 
example, the Brake Services Near-Field/Far-Field exposure model is 
based on a scenario for occupational brake cleaning and may less 
accurately estimate exposures from other applications where exposures 
may be different than those predicted by the model, for example due to 
higher PCE application rates or lower ventilation rates. However, a 
concentration limit of 0.1% provides a margin of error to account for 
the uncertainties associated with the 0.7% concentration limit 
identified in the analysis using the Brake Servicing Near-Field/Far-
Field exposure model. EPA is requesting comment on the de minimus 
concentration limit of PCE in products or formulations, and provides 
more information on consideration of a concentration limit in Unit 
V.A.3. Details of the proposed prohibitions are described in more 
detail in Unit IV.A.
b. Workplace Chemical Protection Program (WCPP)
    One option EPA considered for occupational conditions of use was 
establishing requirements for a PCE WCPP, which would include a 
combination of requirements to the extent necessary to address 
unreasonable risk driven by inhalation and dermal exposures in the 
workplace. A PCE WCPP would encompass restrictions on certain 
occupational conditions of use and could include provisions for an 
ECEL, DDCC, and ancillary requirements to support implementation of 
these exposure limits. Due to the low exposure level and stringent 
requirements in the PCE WCPP that would be necessary to address the 
unreasonable risk from PCE, EPA identified only a relatively small 
number of conditions of use where the Agency expected a PCE WCPP could 
be successfully implemented.
    Existing Chemical Exposure Limit. One requirement considered by EPA 
to include in a PCE WCPP to address unreasonable risk driven by 
inhalation exposures to PCE for occupational conditions of use was 
establishing an ECEL and related implementation measures, such as 
exposure monitoring. As described in Unit IV.A., the PCE WCPP would be 
non-prescriptive, in the sense that regulated entities would not be 
required to use specific controls prescribed by EPA to achieve the 
exposure concentration limit. Rather, it would be a performance-based 
exposure limit that would enable owners or operators to determine how 
to most effectively meet the exposure limit based on conditions at 
their workplace, consistent with the hierarchy of controls.
    A central component of the PCE WCPP is the exposure limit. 
Exposures remaining at or below the ECEL would address any unreasonable 
risk of injury to health driven by inhalation exposures for 
occupational conditions of use.
    In the case of PCE, EPA has calculated the ECEL to be 0.14 parts 
per million (ppm) (0.98 mg/m\3\) for inhalation exposures as an 8-hour 
TWA in workplace settings, based on the chronic, non-cancer HEC for 
neurotoxicity (CNS) (Ref. 10). This is the concentration at which an 
adult human, including a member of a susceptible subpopulation, would 
be unlikely to suffer adverse effects if exposed for a working 
lifetime. The differences between the ECEL and the OSHA PEL are 
discussed in more detail in Unit II.C.1.b. EPA chose the chronic non-
cancer neurotoxicity endpoint for PCE as the basis for this exposure 
limit because it is the most sensitive of the endpoints identified, and 
therefore will be protective of both acute and chronic non-cancer and 
chronic cancer inhalation endpoints over the course of a working day 
and lifetime.
    In deciding whether an ECEL and related required implementation 
measures would appropriately address the unreasonable risk driven by 
occupational inhalation exposures for specific conditions of use, EPA 
considered factors related to work activities that may make it 
difficult to comply with an ECEL, particularly at the low air 
concentration level EPA has identified. Once EPA identified the 
appropriate risk-based inhalation limit to address identified 
unreasonable risk, EPA carefully considered the appropriateness of such 
an exposure control program for each occupational condition of use of 
PCE, in the context of the unreasonable risk. Examples include 
conditions of use with work activities that may take place in the 
field, making it challenging to establish a regulated area and conduct 
monitoring; work activities that may take place in open systems that 
require manual contact with the chemical substance; work activities 
that may take place in small, enclosed spaces, creating challenges for 
implementing engineering controls or using respiratory PPE; work 
activities that require a high range of motion or for some other reason 
create challenges for the implementation of respiratory PPE; and the 
type of PPE that would be needed under the PCE WCPP to meet the ECEL in 
the absence of, or in addition to, other feasible exposure controls, 
based on analysis in the 2020 Risk Evaluation for PCE describing 
expected exposures with and without use of PPE.
    EPA also considered the feasibility of exposure reduction 
sufficient to address the unreasonable risk, including in facilities 
currently complying with the OSHA PEL for PCE or implementing other 
recommended OELs such as the ACGIH TLV. While EPA acknowledges the 
regulated community's expected familiarity with OSHA PELs generally, as 
well as facilities' past and ongoing

[[Page 39694]]

actions to implement the PCE PEL, the value of EPA's exposure limit is 
almost three orders of magnitude lower than the OSHA PEL (The 
differences between the ECEL and the OSHA PEL are discussed in more 
detail in Unit II.C.4; more information on other OELs is in Unit 
II.C.5.). This creates a degree of uncertainty as to whether facilities 
engaging in most conditions of use could meet the ECEL (and associated 
action level) and whether they could do so without relying primarily on 
the use of PPE (which is the least preferred option in the hierarchy of 
controls), and, therefore, whether exposures could be reduced in a 
manner aligned with the hierarchy of controls.
    EPA understands that this uncertainty extends to the feasibility of 
respirators as well. Although respirators, specifically SCBAs, could 
reduce exposures to levels that protect against non-cancer and cancer 
risks, not all workers may be able to wear respirators. Individuals 
with impaired lung function due to asthma, emphysema, or chronic 
obstructive pulmonary disease, for example, may be physically unable to 
wear a respirator. OSHA requires that a determination regarding the 
ability to use a respirator be made by a physician or other licensed 
health-care professional, and annual fit testing is required for tight-
fitting, full-face piece respirators to provide the required 
protection. Individuals with facial hair, such as beards or sideburns 
that interfere with a proper face-to-respirator seal, cannot wear tight 
fitting respirators. In addition, respirators may also present 
communication problems, vision problems, worker fatigue, and reduced 
work efficiency (63 FR 1152, January 8, 1998). According to OSHA, 
``improperly selected respirators may afford no protection at all (for 
example, use of a dust mask against airborne vapors), may be so 
uncomfortable as to be intolerable to the wearer, or may hinder vision, 
communication, hearing, or movement and thus pose a risk to the 
wearer's safety or health.'' (63 FR 1189-1190).
    Direct dermal contact control requirements. Another requirement 
considered by EPA to include in a PCE WCPP to address unreasonable risk 
driven by dermal exposures to PCE for occupational conditions of use 
was requiring DDCC. DDCC under the PCE WCPP would be a process-based 
requirement to prevent direct dermal contact in the workplace by 
separating, distancing, physically removing, or isolating potentially 
exposed persons from direct handling of PCE or from contact with 
equipment or materials on which PCE may exist under routine conditions. 
Similar to the ECEL, DDCC is non-prescriptive, in the sense that it 
would not require a specific control to prevent direct dermal contact; 
rather, it would enable regulated entities to determine how to most 
effectively separate, distance, physically remove, or isolate 
potentially exposed persons from direct dermal contact with PCE based 
on what works best for their workplace, in accordance with the 
hierarchy of controls.
    In deciding whether DDCC would appropriately address the 
unreasonable risk driven by dermal exposures, EPA considered factors 
related to work activities that may make it difficult to eliminate 
direct dermal contact. Examples include work activities that may take 
place in open systems that require manual handling of PCE, such as 
application or removal of PCE or a PCE-containing product through rags, 
aerosols, spray guns, roll applicators, fingers, hands, or other 
materials; or work activities that require a high range of motion or 
for some other reason create challenges for the implementation of 
dermal PPE.
    EPA also considered whether exposures could be reduced in a manner 
aligned with the hierarchy of controls and considered the type of PPE 
that would be needed under the PCE WCPP DDCC to prevent direct dermal 
contact if elimination, substitution, engineering controls, and 
administrative controls are not sufficient to prevent direct dermal 
contact. The 2020 Risk Evaluation for PCE describes expected exposures 
with and without use of PPE; even if chemically resistant gloves are 
used in combination with basic workplace training and specific activity 
training for tasks where dermal exposure can be expected to occur, EPA 
found that dermal exposures would continue to pose risk concerns for 
most conditions of use. However, the 2020 Risk Evaluation for PCE 
identifies several uncertainties regarding the dermal exposures 
modeled. For example, the 2020 Risk Evaluation for PCE does not 
consider the frequency, type, and effectiveness of gloves or other 
types of PPE used or specific workplaces. In addition, the 2020 Risk 
Evaluation for PCE does not specify the specific activity training 
beyond procedure for glove removal and disposal.
    In consideration of the whole of the 2020 Risk Evaluation for PCE, 
including the uncertainties, EPA has preliminarily determined that 
preventing direct dermal contact to PCE through DDCC requirements, 
including requirements to reduce exposures in a manner aligned with the 
hierarchy of controls, workplace specific training, and, if necessary, 
dermal PPE which covers any exposed skin (including hands, legs, torso, 
and face), and PPE training, as described in Unit IV.A.2., for certain 
occupational conditions of use would address the unreasonable risk from 
dermal exposure driven by these conditions of use for potentially 
exposed persons.
    PCE WCPP. Taking into account these considerations, EPA is 
proposing that certain conditions of use would be allowed to continue 
if regulated entities could ensure exposures remain at or below the 
ECEL, direct dermal contact is prevented, and other requirements are 
met in the PCE WCPP. In contrast to considerations that would weigh 
against the likelihood of a facility within a condition of use to 
successfully implement WCPP, there are certain considerations that 
indicate a condition of use would likely be able to achieve effective 
risk management via WCPP. Based on reasonably available information, 
including monitoring data (Refs. 50, 49), process descriptions, and 
information related to considerations described previously in this 
unit, EPA's confidence that requirements to meet an ECEL and prevent 
direct dermal contact can be implemented is highest in highly 
standardized and industrialized settings, such as where PCE is used in 
a closed system.
    For example, one of the conditions of use for which EPA is 
proposing a WCPP is processing of PCE as a reactant. A large volume of 
PCE is processed for this condition of use, which primarily goes 
towards the manufacture of HFC-134a and HFC-125 (Refs. 3, 36). 
Inhalation monitoring data submitted by industry suggests that PCE 
exposures in some facilities may already be below levels that would be 
consistent with the proposed ECEL (Ref. 36). Additionally, the 2020 
Risk Evaluation for PCE supports EPA's conclusion that only small 
reductions in exposure are needed for WCPP ECEL compliance for 
processing of PCE as a reactant. Based on analysis in the 2020 Risk 
Evaluation for PCE describing expected exposures with and without use 
of PPE, EPA identified respirators of APF 25 as the minimum respiratory 
PPE that is sufficient to mitigate the unreasonable risk driven by 
inhalation exposures from this condition of use. Also, for dermal 
exposures, reasonably available information indicates that controls may 
already be in place at some workplaces to prevent or reduce direct 
dermal contact with PCE, including enclosed transfer liquid lines with 
a nitrogen purging mechanism, closed loop samplers, and impervious 
glove liners

[[Page 39695]]

in addition to chemically resistant gloves (Ref. 63).
    Another condition of use for which EPA is proposing the WCPP is the 
industrial and commercial use of PCE as a processing aid in catalyst 
regeneration in petrochemical manufacturing. EPA understands that most 
workplaces using PCE in isomerization and catalytic reforming (the two 
uses of PCE in catalyst regeneration in petrochemical manufacturing) 
already have stringent controls in place that reduce workplace 
exposures. As described in public comments and through engagement with 
the American Fuel and Petrochemical Manufacturers (AFPM), other 
industry trade associations, and individual firms, petroleum refineries 
use PCE in continuous, closed processes, where it is completely 
consumed (Refs. 64, 66, 63). Stakeholders have described how, upon 
delivery by tote or tank truck at refineries, PCE is directly injected 
from a tote into a closed processing unit or transferred from a truck 
into a storage tank that is directly hooked up for direct injection in 
a closed system. Transfer procedures of PCE are performed pursuant to 
comprehensive written procedures under strict PPE guidelines including, 
when appropriate, respirators. Information submitted by AFPM indicates 
that worker exposure is limited to chemical unloading and transfer 
procedures, which, for AFPM members, may range from 10 to 35 times per 
year per site for a 15-minute tote changeout or two to 12 times per 
year per site for a 30- to 60-minute tank truck transfer (Ref. 64).
    While EPA understands that the PCE exposure frequency and duration 
at petroleum refineries may be less than what was assumed in the risk 
evaluation, as described in this unit, EPA does not have any recent air 
monitoring data to confirm that PCE exposures are below the proposed 
ECEL at petroleum refineries. Based on analysis in the 2020 Risk 
Evaluation for PCE describing expected exposures with and without use 
of PPE, EPA identified respirators of APF 10 as the minimum respiratory 
PPE that would be sufficient to mitigate the unreasonable risk driven 
by inhalation exposures from this condition of use. Also, for dermal 
exposures, reasonably available information indicates that controls may 
already be in place to prevent or reduce direct dermal contact with 
PCE, such as using PCE in a closed system to limit exposures and 
implementing comprehensive written procedures with added PPE during 
transfer procedures.
    For both of these conditions of use (processing as a reactant/
intermediate and industrial and commercial use in catalyst regeneration 
in petrochemical manufacturing) the 2020 Risk Evaluation for PCE 
indicates that only small reductions in exposure would be needed for 
WCPP compliance. This suggests that, for these conditions of use, the 
reductions in exposure required to achieve a level that would not 
result in unreasonable risk may be less than for other conditions of 
use. This information together with other considerations previously 
described, including monitoring data indicating exposures near or below 
the ECEL and other reasonably available information indicating 
stringent controls may already be in place, adds to EPA's confidence 
that facilities engaging in these two conditions of use could meet the 
WCPP requirements.
    In addition to EPA's confidence that facilities engaging in these 
conditions of use could meet the WCPP requirements and thus address the 
unreasonable risk, EPA found compelling reasons to allow continued use 
of PCE for these conditions of use because they may complement the 
Agency's efforts to address climate-damaging HFCs under the AIM Act or 
have national security or other significance for critical sectors. For 
processing of PCE as a reactant/intermediate, HFC-134a and HFC-125 are 
two of the regulated substances identified in the AIM Act. The AIM Act 
authorizes EPA to address listed HFCs in three main ways: phasing down 
HFC production and consumption through an allowance allocation program; 
facilitating sector-based transitions to next-generation technologies; 
and issuing certain regulations for purposes of maximizing reclamation 
and minimizing releases of HFCs from equipment and ensuring the safety 
of technicians and consumers. EPA anticipates that many entities 
currently using HFCs with higher global warming potential will 
transition to alternatives with lower global warming potential as 
requirements under the AIM Act take effect. HFC-134a and HFC-125, while 
being regulated substances subject to the overall phasedown in 
production and consumption of regulated substances under the AIM Act, 
are likely to be used in blends to facilitate the transition from other 
HFCs and HFC blends with higher global warming potential in certain 
applications. By allowing for the continued, controlled use of PCE in 
the manufacture of HFC-134a and HFC-125, efforts to shift to chemicals 
or blends with lower global warming potential would not be impeded by 
this rulemaking. Allowing this use to continue, subject to compliance 
with the WCPP, would complement industry's ongoing effort to abate the 
use of HFCs with higher global warming potential.
    For the industrial and commercial use as a processing aid in 
catalyst regeneration in petrochemical manufacturing, information 
submitted to the Agency indicates that isomerization and catalytic 
reforming processes, which may rely on PCE for catalyst regeneration, 
are essential to make gasoline that is compliant with environmental 
regulations, such as the EPA Mobile Source Air Toxics regulations (Ref. 
64, 65). Isomerization is a process that reduces the amount of benzene 
in fuels and catalytic reforming generates hydrogen that is used to 
remove sulfur compounds (Ref. 64). The resulting products from 
isomerization and catalytic reforming processes at petroleum refineries 
are isomerate and reformate, which go into gasoline blends that make up 
an estimated 45% of the gasoline pool in the United States (Ref. 64). 
Based on information submitted to the Agency, EPA believes that 
petroleum refineries can meet the ECEL, and so does not anticipate that 
there would be a meaningful impact on the price of gasoline. However, 
if petroleum refineries are unable to meet or are not already meeting 
WCPP requirements as part of the proposed regulatory action and second 
alternative regulatory action or the prescriptive controls as part of 
the primary alternative action, EPA understands that this rulemaking 
could result in larger impacts to the petroleum refining sector, with 
potential impacts that could include an increase in the price of 
gasoline. Therefore, EPA is requesting comment on the extent to which 
facilities engaged in the industrial and commercial use of PCE as a 
processing aid in catalyst regeneration in petrochemical manufacturing 
may already meet the requirements in the proposed and alternative 
regulatory actions described in Unit IV. to address the unreasonable 
risk and is soliciting comment on the impact of such requirements on 
petroleum refining, with special attention to the price of gasoline.
    For PCE to be available for the downstream industrial and 
commercial uses that would continue under a PCE WCPP, it would need to 
be manufactured (including imported), processed, and distributed in 
commerce. Likewise, as long as PCE remains in use, it must also be 
disposed of. Therefore, EPA is proposing requirements to meet a PCE 
WCPP for manufacture (including import), certain processing conditions 
of use, and disposal, to allow for a continued supply chain for 
specified

[[Page 39696]]

conditions of use while ensuring that workers are not subject to 
unreasonable risk from PCE as it moves throughout the supply chain. For 
recycling and disposal, EPA did not identify human health risk from 
inhalation exposure as a driver of unreasonable risk and is therefore 
not proposing to require an ECEL under the PCE WCPP for recycling and 
disposal activities.
    Details of the proposed PCE WCPP, including provisions for the 
ECEL, DDCC, and prescriptive controls, ancillary required 
implementation measures, requirements for demonstrating compliance and 
requirements for distributors, are described in more detail in Unit 
IV.A.
c. Prescriptive Controls
    Another requirement EPA considered to address unreasonable risk for 
occupational conditions of use was requiring specific controls 
prescribed by EPA, including engineering controls, administrative 
controls, and/or PPE. In the 2020 Risk Evaluation for PCE, EPA 
identified that certain workplace controls could reduce exposures. The 
prescriptive controls EPA considered (such as respirators and gloves) 
are based on information in the 2020 Risk Evaluation for PCE. In 
general, prescriptive controls are not preferred as the primary method 
of risk management because of uncertainties related to feasibility to 
reduce exposures to address the unreasonable risk across all workplaces 
engaged in a condition of use and whether the prescriptive controls 
will be consistently or properly used. EPA understands that workplaces 
have unique processes and equipment in place and that varying levels of 
respiratory protection or dermal PPE may be needed for different 
workplaces. Additionally, as described in Unit III.A.1. and 2., EPA 
received input during required consultations and additional engagement 
that options that align with the hierarchy of controls (i.e., 
elimination and substitution of hazards in the workplace) should be 
preferred over prescriptive controls.
    EPA determined that specific prescriptive controls (i.e., specific 
engineering or administrative controls, or PPE) may not be able to 
eliminate unreasonable risk for some conditions of use when used in 
isolation. In the 2020 Risk Evaluation for PCE, analysis of 
occupational exposure scenarios (OES) indicated that many conditions of 
use still posed risk concerns even with the application of respirators 
with APF 25 or 50 (Ref. 1). Because of the uncertainty regarding the 
feasibility of exposure reductions through engineering controls alone, 
EPA determined that a PCE WCPP ECEL, which would be accompanied by 
monitoring requirements in tandem with the implementation of 
engineering controls, administrative controls, and/or PPE as elements 
of the program, as appropriate, would more successfully reduce exposure 
so that the unreasonable risk is addressed. Additionally, relying 
primarily on respirators and gloves to reduce exposures does not 
consider other more protective controls in the hierarchy, including 
elimination, substitution, engineering controls, and administrative 
controls. For occupational conditions of use where compliance with the 
PCE WCPP ECEL and DDCC is unlikely to be successful, in most cases 
prohibitions (rather than prescribed controls) would be more 
appropriate to ensure that PCE does not present unreasonable risk under 
the conditions of use.
    However, based on the 2020 Risk Evaluation for PCE, EPA considered 
the industrial and commercial use in laboratory chemicals as a strong 
candidate for prescriptive controls. While inhalation exposures from 
the industrial and commercial use of PCE as a laboratory chemical did 
not drive the unreasonable risk determination for PCE, EPA's risk 
estimates were predicated on its finding that expected safety practices 
of using PCE in small amounts under a fume hood reduce the potential 
for inhalation exposures in laboratory settings. To codify assumptions 
made in the 2020 Risk Evaluation for PCE regarding the use of fume 
hoods in laboratory settings, EPA is proposing to require fume hoods in 
laboratory settings that use PCE. This proposed requirement would 
protect potentially exposed persons in laboratory settings by ensuring 
that good laboratory practices that reduce the potential for inhalation 
exposures are consistently applied. Additionally, the 2020 Risk 
Evaluation for PCE determined that dermal exposures from the industrial 
and commercial use of PCE as a laboratory chemical drive the 
unreasonable risk determination for PCE, and analysis in the 2020 Risk 
Evaluation for PCE indicated that there would still be risk concerns 
even if chemically resistant gloves are used in combination with 
specific activity training for tasks where dermal exposure can be 
expected to occur. However, as described earlier, the 2020 Risk 
Evaluation for PCE identifies several uncertainties regarding the use 
of the dermal exposures modeled. For example, the 2020 Risk Evaluation 
for PCE does not consider the frequency, type, and effectiveness of 
gloves or other types of PPE used in laboratory settings. In 
consideration of the whole of the 2020 Risk Evaluation for PCE, 
including these uncertainties, EPA has preliminarily determined that 
preventing direct dermal contact with PCE through dermal PPE which 
covers any exposed skin and PPE training for the industrial and 
commercial use in laboratory chemicals would address the unreasonable 
risk from dermal exposure driven by this condition of use for 
potentially exposed persons. EPA is requesting comment on whether 
preventing dermal contact with PCE through dermal PPE and training 
would adequately address the unreasonable risk from dermal exposures 
for the industrial and commercial use in laboratory chemicals. 
Additionally, most laboratories are regulated by OSHA under 29 CFR 
1910.1450 requirements for occupational exposure to hazardous chemicals 
in laboratories, and therefore may be more conducive to the 
implementation of engineering controls such as fume hoods to evacuate 
vapors and to the proper use and implementation of a dermal PPE program 
to adequately reduce overall exposure to PCE. The industrial and 
commercial use of PCE as a laboratory chemical would be necessary to 
provide for the analysis of monitoring samples required under the ECEL 
under this proposed regulation.
    For certain occupational conditions of use, prescribed engineering 
controls, administrative controls, and PPE were considered as part of 
the alternative regulatory action and are described in more detail 
later in this unit and in Unit IV.B.
2. Alternative Regulatory Actions
    EPA acknowledges that, for some of the occupational conditions of 
use that it is proposing to prohibit, there may be some activities or 
facilities that could conceivably implement requirements under a PCE 
WCPP to ensure that exposure remain below an ECEL and prevent direct 
dermal contact with PCE. In some cases, they may be able to undertake 
more extensive risk reduction measures than EPA currently anticipates. 
Therefore, as a primary alternative regulatory action, described in 
Unit IV.B., EPA is considering and requesting comment on a PCE WCPP--
including requirements to ensure exposures remain below an ECEL and 
prevent direct dermal contact--for some conditions of use of PCE that 
would be prohibited under the proposed regulatory action. For those 
conditions of use that would be subject to the PCE WCPP under the 
primary alternative regulatory action, but not the proposed

[[Page 39697]]

regulatory action, EPA was not able to identify reasonably available 
information such as monitoring data or detailed activity descriptions 
to indicate with certainty that relevant regulated entities for these 
conditions of use could mitigate identified unreasonable risk through a 
PCE WCPP. Due to this uncertainty, EPA is requesting comment on the 
primary alternative regulatory action and in particular the likelihood 
of successful compliance with a PCE WCPP, as described in Unit IV.A., 
for the conditions of use listed for the primary alternative regulatory 
action of PCE WCPP in Unit IV.B.
    EPA understands that some of the workplaces engaged in a condition 
of use may already have stringent engineering controls, administrative 
controls, and PPE in place to reduce inhalation and dermal exposures to 
PCE. As part of the alternative regulatory action, EPA considered 
prescribed engineering controls, administrative controls, and PPE for 
some occupational conditions of use. In contrast to the proposed non-
prescriptive requirements of the WCPP where regulated entities would 
have flexibility to select controls in accordance with the hierarchy of 
controls to comply, EPA understands that requiring specific 
prescriptive controls for certain occupational conditions of use may 
provide greater certainty to some facilities that they are addressing 
the unreasonable risk. However, as summarized in this unit, EPA has 
uncertainty regarding the feasibility of exposure reductions through 
specified engineering controls, administrative controls, and/or PPE to 
address unreasonable risk across all workplaces engaged in certain 
conditions of use. Prescribing specific engineering controls, 
administrative controls, or PPE does not consider distinctions in 
processes, equipment, or workplace layout in all facilities, which may 
result in varying levels and types of controls needed to reduce 
inhalation exposures to below the ECEL or to eliminate direct dermal 
contact. Additionally, as described in Unit V.A.1.b., there is a degree 
of uncertainty regarding applicability of respirators, including their 
feasibility and consistency of proper use, especially when exposure 
monitoring is not regularly conducted. However, as part of the primary 
alternative regulatory action, EPA is considering PPE and soliciting 
comment on prescribing specific engineering and administrative controls 
for some occupational conditions of use. In the 2020 Risk Evaluation 
for PCE, EPA identified PPE that could reduce exposures and is 
therefore considering requiring PPE, including respiratory protection 
and dermal protection, as part of the primary alternative regulatory 
action for those conditions of use where the proposed regulatory action 
is a PCE WCPP. Turning to the use of PPE, however, does not consider 
other more preferable controls in the hierarchy of controls, including 
elimination, substitution, engineering, and administrative controls. As 
part of the primary alternative regulatory action, EPA is soliciting 
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.
    While the use of dermal PPE is typical for the use of PCE as a 
laboratory chemical, EPA recognizes the potential for there to be other 
exposure controls that could prevent direct dermal contact in a 
laboratory setting. Therefore, as part of the primary alternative 
regulatory action, EPA is considering implementation of DDCC as part of 
a PCE WCPP for the industrial and commercial use of PCE as a laboratory 
chemical. Similarly, EPA understands there may be exposure controls 
other than a fume hood that could reduce inhalation exposures in a 
laboratory setting and is therefore considering an ECEL as part of a 
PCE WCPP for the industrial and commercial use of PCE as a laboratory 
chemical.
    EPA also considered proposing a TSCA section 6(g) time-limited 
exemption for conditions of use that are critical to national security 
and infrastructure. Based on reasonably available information, and as 
described earlier in Unit IV.B.2.b, EPA has analyzed the need for an 
exemption and has found that a TSCA section 6(g) exemption may be 
warranted under the second alternative regulatory action for the 
industrial and commercial use in maskant for chemical milling and for 
the industrial and commercial use in vapor degreasing if the workplaces 
engaged in that condition of use cannot meet the requirements of the 
proposed regulatory action (PCE WCPP) or primary alternative regulatory 
action (prescriptive controls) such that those conditions of use would 
no longer drive the unreasonable risk. A section 6(g) exemption may 
mean that the unreasonable risk will not be fully addressed. Note that 
EPA's second alternative regulatory action endeavors to ensure that 
worker protections are in place to the extent practicable and that EPA 
is required to have a time limited requirement for any exemptions 
granted under TSCA section 6(g), necessitating revisiting the need and 
justification for any exemption beyond the initial timeframe.
    Details of the primary alternative regulatory action and second 
alternative regulatory action are described in more detail in Unit 
IV.B.
3. Risk Management Requirements Considered but not Proposed
    Since it is unlikely that all industrial or commercial facilities 
with occupational exposures to PCE would be able to implement a WCPP or 
prescriptive controls, EPA also examined the extent to which a point-
of-sale self-certification requirement in order to purchase and 
subsequently use PCE would further ensure that only facilities able to 
implement and comply with a WCPP or prescriptive controls are able to 
purchase and use PCE, and self-certify to that. Under a self-
certification requirement, entities would submit a self-certification 
to the distributor or retailer each time PCE is purchased. The self-
certification would consist of a statement indicating that the facility 
is implementing a WCPP or required prescriptive controls to control 
exposures to PCE; the self-certification would be signed and presented 
by a person authorized to do so by the facility owner or operator. 
Copies of the self-certification would be maintained as records by both 
the owner or operator and the distributor or retailer where PCE was 
purchased. However, because of the number and types of entities where 
users can obtain PCE or PCE-containing products, EPA does not believe 
the added requirement and subsequent burden of a point-of-sale self-
certification requirement for the use of PCE would be an effective tool 
for preventing facilities that may be unable to comply with the WCPP or 
prescriptive controls of this proposed rulemaking from accessing PCE or 
PCE-containing products. As such, EPA is not proposing a self-
certification requirement as an additional component of the 
requirements for addressing the unreasonable risk of occupational 
exposures to PCE. However, EPA is requesting comment on whether to 
include a self-certification requirement for purchasing PCE or PCE-
containing products. For example, EPA is interested in learning if, for 
distributors and retailers, such a self-certification requirement would 
provide greater certainty that any sale of PCE or PCE-containing 
products would be for uses that are not prohibited and are to a 
facility implementing the WCPP or required prescriptive controls.

[[Page 39698]]

    Also, although NIOSH recognizes PCE as an eye irritant (Ref. 67), 
EPA is not proposing requirements for eye protection from PCE, because 
eye irritation or injury is not a component of the unreasonable risk 
EPA has determined is presented by PCE.
    In considering prescriptive controls as a regulatory action 
described in this unit to address the unreasonable risk driven by dry 
cleaning conditions of use, EPA examined monitoring data from New York 
State Department of Environmental Conservation (NYSDEC) inspections 
reports for the years 2013-2015 submitted in July 2020 during the 
public comment period for the draft 2020 Risk Evaluation for PCE. 
Previously, EPA rated this information as unacceptable for use in the 
final 2020 Risk Evaluation for PCE due to lack of critical metadata on 
sample type and sample duration (Refs. 68, 69). However, during risk 
management, stakeholders confirmed the missing metadata is short-term 
duration area monitoring (Refs. 70, 71). EPA analyzed the data to help 
identify how certain controls may show reductions of PCE concentration 
in ambient air in air monitoring data and reduce risk from inhalation 
exposures for PCE dry cleaning (Ref. 45). The analysis of the data show 
that while certain engineering controls such as 4th generation machines 
and a vapor barrier room result in lower air concentration of PCE based 
on area monitoring results, the overall statistics of the data show 
that PCE air concentrations are generally in exceedance of the ECEL of 
0.14 ppm as an 8-hour TWA. It should be noted that there are 
limitations and uncertainties in using area monitoring data to estimate 
worker exposure. Based on the results of this analysis and the 
uncertainties of the data, EPA reasoned that prescriptive engineering 
controls of requiring 4th generation machines or requiring a vapor 
barrier room do not adequately address the unreasonable risk driven by 
inhalation exposures to workers from the industrial and commercial uses 
of PCE in dry cleaning. An industry stakeholder submitted additional 
NYSDEC inspection reports for the years 2018-2019 in November 2021. EPA 
considered the NYSDEC 2018-2019 inspection reports in the Economic 
Analysis to estimate the age of dry cleaning machines and how much PCE 
each machine typically uses in a year (Ref. 3).
    In place of other regulatory actions, EPA considered limiting the 
weight fraction of PCE in products and formulations to address the 
unreasonable risk. As described in Unit V.A.1.a., EPA determined that 
the unreasonable risk from PCE would not be driven by use of products 
containing PCE at less than 0.1% by weight. Therefore, EPA is proposing 
a de minimis level for products containing PCE at levels of less than 
0.1% to account for impurities that do not drive the unreasonable 
risk., as described in Unit IV.A.1.d. However, for most industrial/
commercial and consumer conditions of use, the concentration limit of 
less than 0.1% is so low that it is highly unlikely that PCE would 
still serve its functional purpose in the product or formulation. EPA 
thus concluded that a weight fraction would essentially function as a 
prohibition for most industrial/commercial and consumer conditions of 
use. EPA therefore did not propose a weight fraction for industrial/
commercial and consumer conditions of use. For the industrial and 
commercial use in solvent-based adhesives and sealants, EPA identified 
several products available on the market at concentrations of PCE 
between 0.1% and 1% by weight (Ref. 1). As part of the primary 
alternative regulatory action, EPA would set a concentration limit of 
PCE in adhesive and sealant products for industrial and commercial use 
to 1%, as described in Unit IV.B.1.c.
4. Additional Considerations
    After considering the different regulatory options under TSCA 
section 6(a), alternatives (described in Unit V.B.), compliance dates, 
and other requirements under TSCA section 6(c), EPA developed the 
proposed regulatory action described in Unit IV.A. to address the 
unreasonable risk from PCE to the extent necessary. To ensure 
successful implementation of this proposed regulatory action, EPA 
considered other requirements to support compliance with the proposed 
regulations, such as requiring monitoring and recordkeeping to 
demonstrate compliance with the PCE WCPP and downstream notification 
regarding the prohibition on manufacturing, processing, distribution in 
commerce, and use of PCE, including products containing PCE. These 
proposed requirements are described in Unit IV.A.
    As required under TSCA section 6(d), any rule under TSCA section 
6(a) must specify mandatory compliance dates, which shall be as soon as 
practicable with a reasonable transition period, but no later than 5 
years after the date of promulgation of the rule (except in the case of 
a use exempted under TSCA section 6(g) or for full implementation of 
ban or phaseout requirements). These compliance dates are detailed in 
Unit IV.A. and IV.B. EPA may finalize significantly shorter or longer 
compliance timeframes based on consideration of public comments. 
Following Panel recommendations in the SBAR report, and described in 
Unit IV., EPA considered reasonable compliance timeframes in response 
to SER input and other appropriate factors, such as the average 
projected useful lifespan of dry cleaning machines, capital costs for 
new equipment, and ongoing regulations and rulemakings, including the 
proposed amendments to the PCE dry cleaning NESHAP (January 5, 2022; 87 
FR 421) (Ref. 33). Additionally, following Panel recommendations in the 
SBAR report, EPA considered compliance timelines based on the 
availability of technically and economically feasible alternatives, as 
well as any information provided by other agencies that set 
requirements for certification or standards relevant to degreasing, 
parts cleaning, or other uses of PCE. Following Panel recommendations 
in the SBAR report, EPA is requesting comment on any additional 
appropriate factors for identifying reasonable compliance timeframes 
and how to weigh the factors for dry cleaning and other industries, as 
well as differing compliance or reporting requirements or timetables 
that account for the resources available to small entities.
B. Consideration of Alternatives in Deciding Whether To Prohibit or 
Substantially Restrict PCE
    Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or 
restrict in a manner that substantially prevents a specific condition 
of use of a chemical substance or mixture, and in setting an 
appropriate transition period for such action, EPA must consider, to 
the extent practicable, whether technically and economically feasible 
alternatives that benefit human health or the environment, compared to 
the use so proposed to be prohibited or restricted, will be reasonably 
available as a substitute when the proposed prohibition or other 
restriction takes effect. To that end, in addition to an Economic 
Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using 
reasonably available information (Ref. 56).
    For this assessment, EPA identified and analyzed alternatives to 
PCE in products relevant to industrial, commercial, and consumer 
conditions of use proposed to be prohibited or restricted, even if such 
restrictions are not anticipated to substantially prevent the condition 
of use. Based on reasonably available information,

[[Page 39699]]

including information submitted by industry, EPA understands viable 
alternatives to PCE may not be available for several conditions of 
use--for example, the industrial and commercial use in maskant for 
chemical milling and for the industrial and commercial use in vapor 
degreasing for certain applications (Refs. 54, 57, 58)--and considered 
that information to the extent practicable in the development of the 
regulatory options as described in Unit III.B.3. For some conditions of 
use, EPA was unable to identify products currently available for sale 
that contain PCE. EPA is soliciting comments on whether there are 
products in use or available for sale relevant to these conditions of 
use that contain PCE at this time, so that EPA can ascertain whether 
there are alternatives that benefit human health or the environment as 
compared to such use of PCE. These conditions of use are detailed in 
the Alternatives Assessment (Ref. 56).
    For conditions of use for which products currently containing PCE 
were identified, EPA identified several hundred commercially available 
alternative products that do not contain PCE, and listed in the 
Alternatives Assessment, to the extent practicable, their unique 
chemical components, or ingredients. For each of these chemical 
components or ingredients, EPA identified whether it functionally 
replaced PCE for the product use and screened product ingredients for 
human health and environmental hazard, as well as identified 
flammability and global warming potential where information was 
reasonably available (Ref. 56). EPA then assigned a rating to the human 
health and environmental hazards, using a methodology described in the 
Alternatives Assessment document. In general, EPA identified products 
containing ingredients with a lower hazard screening rating than PCE 
for certain endpoints, while some ingredients presented higher hazard 
screening ratings than PCE (Ref. 56). These alternative hazard 
screening ratings are described in detail in the Alternatives Analysis 
grouped under common product use categories (Ref. 56). Additionally, 
based on input provided by SERs during the SBAR Panel, EPA understands 
that some available alternatives may present problems for certain 
users. For example, SERs identified concerns with water-based 
alternatives such as potential termite and mold damage to wood in 
buildings or water supply limitations due to a drought. SERs also 
identified concerns with alcohol-based alternatives that present a fire 
risk, and which may require users to acquire certain permits or comply 
with restrictions set by State and local agencies, including fire 
departments. Information regarding potential problems with available 
alternatives as indicated by SERs during the SBAR Panel is outlined in 
the SBAR Panel Report (Ref. 33). Following Panel recommendations in the 
SBAR report, EPA requests public comment about the feasibility of use 
of alternatives to PCE and their availability for conditions of use 
that drive the unreasonable risk.
    In deciding whether to propose prohibition or other significant 
restrictions on a condition of use of PCE and in proposing an 
appropriate transition period for any such action, EPA has therefore, 
pursuant to TSCA section 6(c)(2)(C), considered, to the extent 
practicable, whether technically and economically feasible alternatives 
that benefit human health or the environment, compared to the use 
proposed to be prohibited or restricted, would be reasonably available 
as a substitute when a proposed prohibition or other significant 
restriction would become effective. EPA is additionally requesting 
comment on the Alternatives Assessment as a whole.

VI. TSCA Section 6(c)(2) Considerations

A. Health Effects of PCE and the Magnitude of Human Exposure to PCE

    EPA's analysis of the health effects of PCE and the magnitude of 
human exposure to PCE are in the 2020 Risk Evaluation for PCE (Ref. 1). 
A summary is presented here.
    The 2020 Risk Evaluation for PCE identified potential health 
effects of PCE including non-cancer adverse health effects such as 
neurotoxicity and central nervous system effects, kidney and liver 
effects, immune system toxicity, reproductive toxicity, and 
developmental toxicity and cancer hazards from carcinogenicity as well 
as genotoxicity.
    Among the non-cancer adverse health effects, EPA identified visual 
deficits indicative of neurotoxicity as a primary effect of PCE in 
humans following acute and chronic inhalation and dermal exposures. 
Identified symptoms of neurotoxicity include color confusion, changes 
in visual contrast detection, and alteration of visual-spatial 
function. Impaired visual and cognitive function and diminished color 
discrimination are the most sensitive adverse effects driving the 
unreasonable risk of PCE exposure. Additionally, the 2020 Risk 
Evaluation for PCE identified that PCE exposure is associated with 
several types of cancer, including liver tumors, brain gliomas, kidney 
cancer, and testicular cancer. By the criteria presented in EPA's 
Guidelines for Carcinogen Risk Assessment (Ref. 41), PCE is 
characterized as ``likely to be carcinogenic to humans by all routes of 
exposure'' based on conclusive evidence in mice and rats and suggestive 
evidence in humans.
    Other adverse health effects identified in the 2020 Risk Evaluation 
for PCE identified include central nervous system depression, kidney 
nephrotoxicity and proximal tubule nuclear enlargement, liver necrosis 
and extreme dilation of blood or lymph vessels, reduced sperm quality, 
reduced red blood cells and hemoglobin, increased immune cells, 
decreased fetal/placental weight, developmental neurotoxicity, and 
skeletal effects from chronic exposures (Ref. 1).
    Regarding the magnitude of human exposure, one factor EPA considers 
for the conditions of use that drive unreasonable risk is the size of 
the exposed population which, for PCE, EPA estimates is 67,675 workers 
and 22,090 ONUs (Ref. 3). The number of consumers that use the 
approximately 115 types of products containing PCE each year is 
unknown.
    For the conditions of use that drive the unreasonable risk for PCE, 
PESS include workers, ONUs, consumer users, and bystanders to consumers 
using products containing PCE. Children of workers present at dry 
cleaners are also a PESS group exposed to PCE during industrial and 
commercial use of PCE in dry cleaning and spot cleaning.
    In addition to workers, ONUs, consumers, and bystanders to consumer 
use directly exposed to PCE, EPA recognizes there is exposure to the 
general population from air and water pathways for PCE. As mentioned in 
Unit II.D., EPA has separately conducted a screening approach to assess 
whether there may be potential risks to the general population from 
these exposure pathways. While the use of this screening approach 
indicates that EPA is not able to find that there are no potential 
risks to fenceline communities, the screening approach was not designed 
to facilitate the making of an unreasonable risk determination for 
these communities. This unit summarizes the results of that fenceline 
analysis. Although EPA is not making a determination of unreasonable 
risk based on the fenceline screening analysis, the proposed regulatory 
action described in Unit IV. is expected to reduce the risks identified 
in the screening approach.

[[Page 39700]]

    As described in Unit II.D., EPA's analysis methodology was 
presented to the SACC peer review panel in March 2022, and EPA plans to 
consider SACC feedback (including the SACC recommendation to EPA to 
consider multiple years of release data to estimate exposures and 
associated risks) and make decisions regarding how to assess general 
population exposures in upcoming risk evaluations, such as for the 1,4-
dioxane supplement, the forthcoming 20 High Priority Substances, and 
manufacturer-requested risk evaluations. For PCE, EPA recognizes that a 
key input into the fenceline analysis for the ambient air pathway was 
data on releases from the most recent Toxics Release Inventory (TRI) 
reporting year and that the use of more than one year of data could 
result in different conclusions. Accordingly, in this unit EPA presents 
the results of its water pathway fenceline analysis based on PCE 
releases to water and its ambient air pathway fenceline analysis based 
on PCE releases reported to TRI over a single reporting year as well as 
over multiple years (Refs. 72, 73).
    EPA's fenceline analysis for the air pathway for PCE indicates that 
EPA is not able to conclude that there are no potential risks to 
fenceline communities, described further in this unit. Additionally, 
based on the fenceline analysis for the ambient air pathway for PCE, 
including the strengths, limitations, and uncertainties associated with 
the information used to inform the analysis, EPA is unable to determine 
with this analysis whether those risks drive the unreasonable risk of 
injury to health presented by PCE. Standard cancer benchmarks used by 
EPA and other regulatory agencies are an increased cancer risk above 
benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 (i.e., 1 x 
10^-\6\ to 1 x 10^-\4\) depending on the 
subpopulation exposed (see, e.g., EPA's interpretation set forth in 54 
FR 38044 (Sept. 14, 1989) which discusses the use of benchmarks for 
purposes of Section 112 of the Clean Air Act (CAA); see also EPA's 
interpretation of the upper bound of acceptable risk and the preferred 
benchmark described in the Letter of Concern regarding EPA Complaint 
Nos. 01R-22-R6, 02R-22-R6, and 04R-22 -R6 see page 3 footnotes 5 and 6 
and page 6 (Ref. 74)). In this fenceline analysis for the ambient air 
pathway for PCE, estimates of risk to fenceline communities were 
calculated using 1 x 10^-\6\ as the benchmark for cancer risk 
in fenceline communities. While EPA is unable to determine, based on 
the screening level fenceline analysis, whether risks to the general 
population drive the unreasonable risk, as a matter of risk management 
policy EPA considers the range of 1 x 10^-\6\ to 1 x 
10^-\4\ as the appropriate benchmark for increased cancer 
risk for the general population, including fenceline communities. It is 
preferable to have the air concentration of PCE result in an increased 
cancer risk closer to the 1 x 10^-\6\ benchmark, with the 1 x 
10^-\4\ benchmark generally representing the upper bound of 
acceptability for estimated excess cancer risk. The benchmark value is 
not a bright line, and the Agency considers a number of factors when 
determining unreasonable risk, such as the endpoint under 
consideration, the reversibility of effect, and exposure-related 
considerations (e.g., duration, magnitude, or frequency of exposure, or 
population exposed).
    In this unit, EPA presents the results of its ambient air pathway 
fenceline analysis and the uncertainties associated with the analysis. 
EPA also describes how the proposal to prohibit the manufacturing 
(include importing), processing, and distribution in commerce of PCE 
for most industrial and commercial use and all consumer use, and to 
prohibit most industrial and commercial use of PCE, is expected to 
reduce the potential risks identified in the screening analysis to any 
general population or fenceline communities close to facilities 
engaging in PCE use. This unit also describes how EPA believes the 
proposed WCPP requirements may reduce exposures to the general 
population for facilities identified in the fenceline analysis with 
expected exposures to fenceline communities that are associated with 
conditions of use EPA is not proposing to prohibit. EPA therefore does 
not intend to revisit the air pathway for PCE as part of a supplemental 
risk evaluation.
    There are some uncertainties associated with the fenceline analysis 
for the air pathway for PCE. The TRI dataset used for the single- and 
the multi-year fenceline analysis and land use analysis does not 
include actual release point locations which can affect the estimated 
concentrations at varying distances modeled. To identify the release 
location for each facility, EPA used a local-coordinate system based on 
latitude/longitude coordinates reported in TRI. The latitude/longitude 
coordinates may represent the mailing address location of the office 
building associated with a very large facility or some other area of 
the facility rather than the actual release location (e.g., a specific 
process stack). This discrepancy between the coordinates reported in 
TRI and the actual release point could result in an exposure 
concentration that does not represent the actual distance where 
fenceline communities may be exposed. The fenceline analysis also 
evaluated the most ``conservative exposure scenario'' that consists of 
a facility that operates year-round (365 days per year, 24 hours per 
day, 7 days per week) in a South Coastal meteorologic region and a 
rural topography setting (Ref. 73). Therefore, the modeled exposures to 
receptors may be overestimated if there are fewer exposure days per 
year or hours per day. Additionally, the ambient air fenceline analysis 
organizes facilities and associated risks by OES and generally 
crosswalks each OES with the associated condition of use of PCE (Ref. 
73). For some OES, EPA identified the associated conditions of use to 
the category level in the December 2020 Risk Evaluation for PCE but was 
unable identify to the conditions of use to the subcategory level due 
to limited information on activities and use of PCE reported under TRI. 
Therefore, some OES indicating increased cancer risk from ambient air 
exposures to PCE in the air fenceline analysis may be associated with 
one or more conditions of use of PCE.
    EPA's single year fenceline analysis for the ambient air pathway, 
based on methods presented to the SACC, evaluated PCE releases reported 
to TRI over the 2019 reporting year. This single year fenceline 
analysis identified 65 facilities with some indication of releases and 
potential exposure with associated cancer risk to receptors within 
select distances evaluated from 5 to 1,000 meters from the respective 
releasing facility. Separately, following SACC feedback, EPA applied a 
slightly modified pre-screening methodology to evaluate 6 years of PCE 
release data (2015 through 2020 TRI data as well as the 6-year average 
of that data) rather than a single year of data for facilities with 
reported releases in TRI. The multi-year fenceline analysis identified 
30 facilities with some indication of releases and potential exposures 
and associated cancer risk at a distance of 100 meters from the 
releasing facility. Based on the multi-year fenceline analysis, 12 of 
these 30 facilities either had risks above the benchmark for cancer at 
distances farther out to 100 meters when compared to the single year 
analysis or are facilities that were not captured in the single-year 
analysis (e.g., did not report in 2019 TRI). Although the multi-year 
analysis identified several additional facilities with risk estimates 
above the benchmark for cancer farther out when

[[Page 39701]]

compared to the single year analysis or that were not captured in the 
single-year analysis, the results of overall risk profiles (i.e., OES 
and corresponding conditions of use with risk estimates above the 
benchmark for cancer at the distances evaluated) for the single year 
and multi-year fenceline analyses are the same. While the fenceline 
analysis identified facilities with some indication of releases and 
potential exposure with associated increased cancer risk that exceeds 
the 1 x 10^-\6\ benchmark at a distance of 100 meters from 
the releasing facility, the analysis did not identify any facilities 
exceeding the 1 x 10^-\4\ benchmark; the highest risk 
estimate is in the 1 x 10^-\5\ range (Ref. 73).
    EPA conducted a land use analysis to determine if EPA can 
reasonably expect an exposure to fenceline communities to occur within 
the modeled distances for facilities where there was an indication of 
risk in the single year or multi-year fenceline analysis. This review 
consisted of a visual analysis using aerial imagery and interpreting 
land/use zoning practices around the facility to identify where 
residential, industrial/commercial businesses, or other public spaces 
are present within those radial distances indicating risk (as opposed 
to uninhabited areas), as well as whether the radial distances lie 
outside the boundaries of the facility. The land use analysis of the 65 
facilities indicating risk in the single-year fenceline analysis 
identified 24 facilities with expected exposure to fenceline 
communities. The land use analysis of the 12 additional facilities 
indicating risk in the multi-year fenceline analysis (i.e., facilities 
where risk estimates were above the benchmark for cancer at distances 
farther out when compared to the single-year analysis or facilities 
that were not captured in the single year analysis) identified 5 
additional facilities with expected exposure to fenceline communities. 
Overall, the land use analysis identified a total of 29 facilities, 
representing eight OES, with expected exposure to fenceline 
communities. Those eight OES include: maskant for chemical milling; 
incorporation into formulation, mixture, or reaction product; 
industrial processing aid; metalworking fluids; other industrial uses--
textile processing; degreasing (batch open-top degreasing; batch 
closed-loop degreasing; conveyorized vapor degreasing; web vapor 
degreasing; cold cleaning); manufacturing; and processing as a reactant 
(Ref. 73).
    Under the proposed regulatory action described in Unit IV.A., all 
of the conditions of use associated with the metalworking fluids and 
other industrial uses--textile processing OES would be prohibited. EPA 
is also proposing to prohibit the processing into formulation, mixture 
or reaction product for other chemical products and preparations that 
may be associated with the facilities for the incorporation into 
formulation, mixture or reaction product OES; the industrial and 
commercial use as a processing aid in pesticide, fertilizer and other 
agricultural chemical manufacturing that may be associated with the 
facilities for the processing aid OES; and the industrial and 
commercial use as solvent for cold cleaning that may be associated with 
the degreasing OES (batch open-top degreasing; batch closed-loop 
degreasing; conveyorized vapor degreasing; web vapor degreasing; cold 
cleaning). As a result, exposures to any fenceline communities from 
these facilities would be addressed under the prohibitions in the 
proposed rulemaking.
    The remaining facilities with expected exposure to fenceline 
communities may be associated with the following conditions of use that 
EPA is not proposing to prohibit: manufacturing; processing as a 
reactant/intermediate; processing into formulation, mixture or reaction 
product for cleaning and degreasing products; processing into 
formulation, mixture, or reaction product for paint and coating 
products; processing into formulation, mixture, or reaction product for 
adhesives and sealants; industrial and commercial use as solvent for 
open-top batch vapor degreasing; industrial and commercial use as 
solvent for closed-loop batch vapor degreasing; industrial and 
commercial use as solvent for in-line conveyorized vapor degreasing; 
industrial and commercial use as solvent for in-line web cleaner vapor 
degreasing; industrial and commercial use in maskants for chemical 
milling; and industrial and commercial use as a processing aid in 
catalyst regeneration in petrochemical manufacturing. For these 
conditions of use that may be associated with facilities that indicate 
expected exposure to fenceline communities, the proposed rule would 
require strict workplace exposure controls via implementation of a WCPP 
as described in Unit IV.A.2. Under the proposed WCPP requirements, 
facilities would need to monitor PCE air concentrations by taking 
personal breathing zone air samples of potentially exposed persons, 
which would allow facilities to better understand and manage the total 
releases of PCE within the facility and potentially stack and fugitive 
emissions. Furthermore, under the WCPP requirements, facilities would 
need to evaluate controls to determine how to reduce releases and 
exposures to potentially exposed persons in the workplace. EPA 
anticipates that this analysis would help facilities to determine the 
most effective ways to reduce exposures (including possible engineering 
controls or elimination/substitution of PCE) and whether those methods 
for exposure reduction impact releases, and therefore may reduce the 
overall risk to fenceline communities. EPA requests comment on whether 
owners and operators should be required to attest to whether and why 
the exposure controls they have selected would not result in increased 
air releases of PCE from the workplace, and keep records of that 
statement as part of the WCPP exposure control plan.
    Under the proposed rule, only 17 conditions of use would continue 
(see Unit IV.C. for a summary). For many of these conditions of use, 
EPA expects use to decline over time. For example, the manufacturing 
and processing into formulation, mixture, or reaction product 
conditions of use can reasonably be expected to decline because, while 
manufacturing and processing into a formulation, mixture, or reaction 
product could continue under a WCPP, downstream distribution and use of 
formulations, mixtures, or reaction products other than for vapor 
degreasing, chemical milling, adhesives and sealants, petrochemical 
manufacturing, and laboratory use would be prohibited. Additionally, 
EPA expects the industrial and commercial use of PCE as a reactant in 
the generation of HFC-134a and HFC-125 to also 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. HFC-125 and 
HFC-134a are two of the regulated substances that are subject to the 
AIM Act phasedown.
    For all 17 conditions of use that would remain ongoing, the 
proposed rule would require strict workplace exposure controls via 
implementation of a WCPP or prescriptive workplace controls for 
laboratory use, as described in Unit IV.A.1. In the instances where 
efforts to reduce exposures in the workplace to levels below the ECEL 
could lead to adoption of engineering controls that ventilate more PCE 
outside, EPA believes this potential exposure would be limited as a 
result of the existing NESHAP for PCE for these conditions of use under 
the CAA. Applicable NESHAP include: 40 CFR

[[Page 39702]]

part 63, subpart F, Synthetic Organic Chemical Manufacturing Industry; 
40 CFR part 63, subpart DD, Off-Site Waste and Recovery Operations; 40 
CFR part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part 
63, subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part 
63, subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR 
part 63, subpart T, Halogenated Solvent Cleaning, which impose emission 
standards and work practice requirements reflecting maximum achievable 
control technologies and generally available control technologies. The 
CAA required residual risk reviews for standards reflecting maximum 
achievable control technologies, and technology reviews are required 
every 8 years for all NESHAP.
    EPA's fenceline analysis for the water pathway for PCE, based on 
methods presented to the SACC, did not find risks from drinking water, 
incidental oral ingestion of surface water, or incidental dermal 
exposure to surface water (Ref. 72). EPA therefore does not intend to 
revisit the water pathway for PCE as part of a supplemental risk 
evaluation.

B. Environmental Effects of PCE and the Magnitude of Exposure of the 
Environment to PCE

    EPA's analysis of the environmental effects of PCE and the 
magnitude of exposure of the environment to PCE are in the 2020 Risk 
Evaluation for PCE (Ref. 1). The unreasonable risk determination for 
PCE is based solely on risks to human health; based on the TSCA 2020 
Risk Evaluation for PCE, EPA determined that exposures to the 
environment did not drive the unreasonable risk. A summary is presented 
here.
    The manufacturing, processing, use, and disposal of PCE can result 
in releases to the environment, including aquatic releases of PCE from 
facilities that manufacture, use, or process PCE. Fate, exposure, and 
environmental hazard were evaluated in the 2020 Risk Evaluation for PCE 
in order to characterize environmental risk of PCE. PCE has low 
bioaccumulation potential and moderate potential to accumulate in 
wastewater biosolids, soil, or sediment. Releases of PCE to the 
environment are likely to volatilize to the atmosphere, where it will 
slowly photooxidize. It may migrate to groundwater, where it will 
slowly hydrolyze. Additionally, the bioconcentration potential of PCE 
is low.
    Potential effects of PCE exposure described in the literature for 
aquatic life include mortality, developmental deformities, 
immobilization, reproductive effects, growth effects, and biomass 
effects. EPA concluded that PCE poses a hazard to environmental aquatic 
organisms, including aquatic invertebrates, fish, amphibians, and 
aquatic plants (algae). For acute exposures, PCE is a hazard to aquatic 
invertebrates based on immobilization, to fish based on immobilization 
of midge larvae at 7.0 mg/L, to fish based on mortality of rainbow 
trout as the most sensitive species with acute toxicity values as low 
as 4.8 mg/L, and amphibians based on developmental effects to the wood 
frog as the most sensitive species with acute toxicity values as low as 
7.8 mg/L. For chronic exposures, PCE is a hazard to aquatic 
invertebrates, with a toxicity value of 0.5 mg/L; and a chronic 
toxicity value of 0.84 mg/L for fish. PCE is also a hazard for green 
algae with a toxicity value of 3.6 mg/L. EPA incorporated modeled 
exposure data from the Exposure and Fate Assessment Screening Tool or 
E-FAST (Ref. 75), as well as monitored data from the Water Quality 
Portal (Ref. 76), to characterize the exposure of PCE to aquatic 
species.
    In the 2020 Risk Evaluation for PCE, the indicators evaluated for 
risk of injury to the environment include immobilization from acute 
exposure, growth effects from chronic exposure, and mortality to algae 
(Ref. 1). Based on the 2020 Risk Evaluation for PCE, EPA did not 
identify risk of injury to the environment that drive the unreasonable 
risk determination for PCE.

C. Benefits of PCE for Various Uses

    PCE is a solvent used in a variety of industrial, commercial, and 
consumer use applications, including as a feedstock in the production 
of fluorinated compounds, cleaning and degreasing, adhesives and 
sealants, paints and coatings, lubricants and greases, processing aid, 
and other uses. The physical and chemical properties of PCE, such as 
non-flammability, high volatility, low global warming potential, low 
vapor pressure, high chloride density, high boiling point, and high 
solvency of oils, waxes, and greases, as well as relatively low cost, 
make it a popular and effective solvent for many applications (Refs. 1, 
77, 78).
    The largest uses of PCE, by production volume, are processing as a 
reactant and as a solvent in dry cleaning and vapor degreasing (Ref. 
1). Based on the 2020 Risk Evaluation for PCE, nearly 65% of the 
production volume of PCE is used as an intermediate in industrial gas 
manufacturing and producing fluorinated compounds. The leading 
fluorocarbons being produced from PCE are HFC-134a and HFC-125, 
although a small amount of PCE may be used in the production of CFC-113 
for applications vital to U.S. security exempted under Title VI of the 
Clean Air Act Amendments of 1990 (40 CFR part 82), HCFC-123, and HCFC-
124. The second largest use of PCE is as a solvent in dry cleaning 
facilities. PCE effectively dissolves fats, greases, waxes and oils, 
without harming natural or human-made fibers. However, there appears to 
be a trend towards alternatives to PCE in dry cleaning and the demand 
for PCE dry cleaning solvents has steadily declined as a result of the 
improved efficiency of dry cleaning equipment, increased chemical 
recycling and the popularity of wash-and-wear fabrics that eliminate 
the need for dry cleaning (Refs. 79, 1). According to the 2020 Risk 
Evaluation for PCE, the third largest use of PCE is as a vapor 
degreasing solvent. PCE can be used to dissolve many organic compounds, 
select inorganic compounds and high-boiling waxes and resins, making it 
useful for cleaning contaminated metal parts and other fabricated 
materials (Ref. 79). Based on market research, EPA understands that use 
of PCE as a vapor degreasing solvent has declined and estimates there 
are 88 facilities that use PCE for vapor degreasing nationwide (Ref. 
3).
    PCE has many other uses, which, based on the 2020 Risk Evaluation 
for PCE, collectively constitute about 10% of the production volume 
(Ref. 1). In petrochemical manufacturing, PCE is used as a chloriding 
agent for reforming and isomerization catalyst process units, which 
account for approximately 45% of the gasoline pool in the United States 
(Refs. 66, 63). The high chloride density of PCE minimizes the amount 
of chemical needed for catalyst regeneration compared to other 
chloriding agents and the non-flammability is important for process 
considerations. PCE is also used in maskant for chemical milling, 
plating, and anodizing processes in the aerospace (military, 
commercial, and space) and non-aerospace military industries (Ref. 1), 
as well as in a mission-critical elastomer adhesive used in human-rated 
rocket motor assembly (including rocket motor subsystem components such 
as the rocket motor nozzle assembly) (Ref. 59).

[[Page 39703]]

D. Reasonably Ascertainable Economic Consequences of the Proposed Rule

1. Likely Effect of the Rule on the National Economy, Small Business, 
Technological Innovation, the Environment, and Public Health
    The reasonably ascertainable economic consequences of this proposed 
rule include several components, all of which are described in the 
Economic Analysis for this proposed rule (Ref. 3). With respect to the 
anticipated effects of this proposed rule on the national economy, EPA 
considered the number of businesses and workers that would be affected 
and the costs and benefits to those businesses and workers and did not 
find that there would be an impact on the national economy (Ref. 3). 
The economic impact of a regulation on the national economy becomes 
measurable only if the economic impact of the regulation reaches 0.25% 
to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is 
equivalent to a cost of $40 billion to $80 billion. Therefore, because 
EPA has estimated that the monetized cost of the proposed rule would 
range from $14.0 million annualized over 20 years at a 3% discount rate 
and $14.3 million annualized over 20 years at a 7% discount rate, EPA 
has concluded that this rulemaking is highly unlikely to have any 
measurable effect on the national economy (Ref. 3). In addition, EPA 
considered the employment impacts of this proposed rule, and found that 
the direction of change in employment is uncertain, but EPA expects the 
short-term and longer-term employment effects to be small.
    There are an estimated 12,202 small entities affected by the 
proposed option with a per firm and total estimated cost impact of $850 
and $10.4 million, respectively. Of the small businesses potentially 
impacted by this proposed rule, over 99% are expected to have impacts 
of less than 1% to their firm revenues, 0.1% are expected to have 
impacts between 1 and 3% to their firm revenues, and 0.2% are expected 
to have impacts greater than 3% to their firm revenues. EPA estimates 
that there are currently 6,000 firms currently using PCE dry cleaning 
machines, but estimates that only 62 would still be using PCE for dry 
cleaning by the end of the proposed 10-year phaseout. As described 
further in the Economic Analysis, EPA believes that almost no new PCE 
machines have been brought into service in recent years and therefore 
most existing dry cleaning machines using PCE are old and will no 
longer be in service by the proposed phaseout date. Based on the 
estimated revenues per firm presented in Table 3-1 of the Economic 
Analysis and the 6,000 estimated number of dry cleaning firms using PCE 
as dry cleaning solvent (see section 6.1.5 (A) of the Economic 
Analysis), the total revenue for dry cleaning firms using PCE as dry 
cleaning solvent is approximately $3.1 billion. According to IRS (2013) 
data, profit in this sector is about 4.8% of sales, implying that total 
profit of firms using PCE as dry cleaning solvent is about $148 
million. However, EPA has proposed a 10-year phaseout of PCE in dry 
cleaning and estimates that only about 60 PCE dry cleaning machines 
would remain at the end of the phaseout (see section 7.7.3. of the 
Economic Analysis). This suggests that the proposed option would only 
affect about $31 million of the industry's total revenue and about $1.5 
million of the industry's profit. Many of these firms would likely 
choose to purchase non-PCE machines or become drop shops (do dry 
cleaning at another site) rather than close. A detailed sensitivity 
analysis of varying assumptions on ages of PCE dry cleaning machines 
and PCE dry cleaning machine life is provided in section 11 of the 
Economic Analysis. EPA requests comment on these estimated impacts to 
the dry cleaning industry, including regarding expected closures. In 
addition to dry cleaners, additional users of PCE (such as in vapor 
degreasing) could be strongly impacted because they may have no 
economical alternative to the use of PCE.
    With respect to this proposed rule's effect on technological 
innovation, EPA expects this rulemaking to spur more innovation than it 
will hinder. A prohibition or significant restriction on the 
manufacture, processing, and distribution in commerce of PCE for uses 
covered in this proposed rule may increase demand for safer chemical 
substitutes. This proposed rule is not likely to have significant 
effects on the environment because PCE does not present an unreasonable 
risk to the environment, though this proposed rule does present the 
potential for small reductions in air emissions and soil contamination 
associated with improper disposal of products containing PCE. The 
effects of this proposed rule on public health are estimated to be 
positive, due to the reduced risk of cancer and other non-cancer 
endpoints from exposure to PCE.
2. Costs and Benefits of the Proposed Regulatory Action and of the One 
or More Primary Alternative Regulatory Actions Considered by the 
Administrator
    The costs and benefits that can be monetized for this proposed rule 
are described at length in in the Economic Analysis (Ref. 3). The 
monetized costs for this proposed rule are estimated to range from 
$14.0 million annualized over 20 years at a 3% discount rate and $14.3 
million annualized over 20 years at a 7% discount rate. The monetized 
benefits are estimated to be $10.2 to $46.3 million annualized over 20 
years at a 3% discount rate and $4.72 million to $29.4 million 
annualized over 20 years at a 7% discount rate. Costs do not include 
possible additional costs from prohibition of all uses of PCE (except 
for petrochemical processing) due to need to switch processes or 
chemicals. EPA requests comment on costs that may be incurred by firms 
using PCE products to identify suitable alternatives, test them for 
their desired applications, learn how to use them safely and 
effectively, and implement new processes for using the alternative 
products.
    EPA considered the estimated costs to regulated entities as well as 
the cost to administer and enforce alternative regulatory actions. The 
primary and second alternative regulatory actions are described in 
detail in Unit IV.B. The estimated annualized costs of the primary 
alternative regulatory action are $14.5 million at a 3% discount rate 
and $14.7 million at a 7% discount rate over 20 years (Ref. 3). The 
estimated annualized costs of the second alternative regulatory action 
are $17.8 million at a 3% discount rate and $19.5 million at a 7% 
discount rate over 20 years. The monetized benefits of the primary 
alternative action are estimated to be $10.2 to $46.2 million 
annualized over 20 years at a 3% discount rate and $4.71 million to 
$29.3 million annualized over 20 years at a 7% discount rate (Ref. 3). 
The monetized benefits of the second alternative action are estimated 
to be $10.2 to $46.4 million annualized over 20 years at a 3% discount 
rate and $4.73 million to $29.4 million annualized over 20 years at a 
7% discount rate. Costs of the second alternative action do not include 
possible additional costs from prohibition of non-petrochemical 
processing and chemical milling uses of PCE. These costs for chemical 
milling could be significant as there is no alternative to the use of 
PCE in chemical milling for many users. For vapor degreasing, as 
described in the Economic Analysis, EPA assumes that

[[Page 39704]]

there are alternatives to PCE for all users, although switching to some 
of these alternatives may be very expensive due to required 
revalidation and possible equipment changes. At least one user has told 
EPA that they have no alternative to the use of PCE in closed-loop 
vapor degreasing and at least one other user has requested a 10-year 
phaseout for the use of PCE in vapor degreasing due to the needs for 
revalidation and possible equipment changes throughout the supply chain 
(Ref. 3).
    This proposal is 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. EPA believes that the 
balance of costs and benefits of this proposal cannot be fairly 
described without considering the additional, non-monetized benefits of 
mitigating the non-cancer adverse effects. These effects may include 
neurotoxicity, kidney toxicity, liver toxicity, immunological and 
hematological effects, reproductive effects, and developmental effects. 
The multitude of adverse effects from PCE exposure can profoundly 
impact an individual's quality of life, as discussed in Unit II.A. 
(overview), III.B.2. (description of the unreasonable risk), VI.A. 
(discussion of the health effects), and the 2020 Risk Evaluation for 
PCE. Chronic adverse effects of PCE exposure include both cancer and 
the non-cancer effects listed above. Acute effects of PCE exposure 
could be experienced for a shorter portion of life but are nevertheless 
significant in nature. The incremental improvements in health outcomes 
achieved by given reductions in exposure cannot be quantified for non-
cancer health effects associated with PCE exposure, and therefore 
cannot be converted into monetized benefits. The qualitative discussion 
throughout this rulemaking and in the Economic Analysis highlights the 
importance of these non-cancer effects. These effects include 
willingness-to-pay to avoid illness, which includes cost of illness and 
other personal costs such as pain and suffering. Considering only 
monetized benefits underestimates the impacts of PCE adverse outcomes 
and therefore underestimates the benefits of this proposed rule.
3. Cost Effectiveness of the Proposed Regulatory Action and of the 1 or 
More Primary Alternative Regulatory Actions Considered by the 
Administrator
    Cost effectiveness is a method of comparing certain actions in 
terms of the expense per item of interest or goal. A goal of this 
proposed regulatory action is to prevent unreasonable risk resulting 
from exposure to PCE. The proposed regulatory action would cost $3.0 
million per potential prevented cancer case while the primary 
alternative regulatory action would cost $3.1 million (using the 3% 
discount rate) and the second alternative regulatory action would cost 
$3.8 million to achieve the same goals. At a 7% discount rate, the 
proposed regulatory action would cost $3.0 million per potential 
prevented cancer case while the primary alternative regulatory action 
would cost $3.1 million, and the second alternative regulatory action 
would cost $4.2 million to achieve the same goals. While the proposed 
regulatory action is lower in cost compared to the other alternative 
actions, the difference is small (Ref. 3).

VII. TSCA Section 9 Analysis, Section 14, and Section 26 Considerations

A. TSCA Section 9(a) Analysis

    TSCA section 9(a) provides that, if the Administrator determines, 
in the Administrator's discretion, that an unreasonable risk may be 
prevented or reduced to a sufficient extent by an action taken under a 
Federal law not administered by EPA, the Administrator must submit a 
report to the agency administering that other law that describes the 
risk and the activities that present such risk. Section 9(a) describes 
additional procedures and requirements to be followed by EPA and the 
other Federal agency following submission of any such report. As 
discussed in this unit, for this proposed rule, the Administrator 
proposes to exercise his discretion not to determine that the 
unreasonable risk from PCE under the conditions of use may be prevented 
or reduced to a sufficient extent by an action taken under a Federal 
law not administered by EPA.
    In addition, TSCA section 9(d) instructs the Administrator to 
consult and coordinate TSCA activities with other Federal agencies for 
the purpose of achieving the maximum enforcement of TSCA while imposing 
the least burdens of duplicative requirements. For this proposed rule, 
EPA has and continues to coordinate with appropriate Federal executive 
departments and agencies, including OSHA and the Consumer Product 
Safety Commission (CPSC), to, among other things, identify their 
respective authorities, jurisdictions, and existing laws with regard to 
PCE, which are summarized in this unit.
    OSHA requires that employers provide safe and healthful working 
conditions by setting and enforcing standards and by providing 
training, outreach, education and assistance. As described in Unit 
II.C., OSHA, in 1971, established a PEL for PCE of 100 ppm of air as an 
8-hour TWA with an acceptable ceiling concentration of 200 ppm and an 
acceptable maximum peak above the acceptable ceiling concentration for 
an eight-hour shift of 300 ppm, maximum duration of 5 minutes in any 3 
hours. However, the exposure limits established by OSHA are higher than 
the exposure limit that EPA determined would be sufficient to address 
the unreasonable risk identified under TSCA from occupational 
inhalation exposures associated with certain conditions of use. Gaps 
exist between OSHA's authority to set workplace standards under the OSH 
Act and EPA's obligations under TSCA section 6 to eliminate 
unreasonable risk presented by chemical substances under the conditions 
of use. Health standards issued under section 6(b)(5) of the OSH Act 
must reduce significant risk only ``to the extent feasible.'' 29 U.S.C. 
655(b)(5). To set PELs for chemical exposure, OSHA must first establish 
that the new standards are economically and technologically feasible 
(79 FR 61384, 61387, Oct. 10, 2014). But under TSCA section 6(a), EPA's 
substantive burden is to demonstrate that, as regulated, the chemical 
substance no longer presents an unreasonable risk, with unreasonable 
risk being determined without consideration of costs or other nonrisk 
factors. Thus, if OSHA were to initiate a new action to lower its PEL, 
the difference in standards between the OSH Act and TSCA may well 
result in the OSHA PEL being set at a higher level than the exposure 
limit that EPA determined would be sufficient to address the 
unreasonable risk under TSCA.
    In addition, OSHA may set exposure limits for workers, but its 
authority is limited to the workplace and does not extend to consumer 
uses of hazardous chemicals, and thus OSHA cannot address the 
unreasonable risk from PCE under all of its conditions of use, which 
include consumer uses. OSHA also does not have direct authority over 
State and local employees, and it has no authority over the working 
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
    CPSC, under authority provided to it by Congress in the CPSA, 
protects the public from unreasonable risk of injury or death 
associated with the use of consumer products. Under the CSPA, CPSC has 
the authority to regulate PCE in consumer products, but not in other 
sectors such as automobiles, industrial

[[Page 39705]]

and commercial products, or aircraft, for example. Further, a consumer 
product safety rule under the CPSA must include a finding that ``the 
benefits expected from the rule bear a reasonable relationship to its 
costs,'' 15 U.S.C. 2058(f)(3)(E), whereas EPA must apply TSCA risk 
management requirements to the extent necessary so that the chemical no 
longer presents unreasonable risk and only consider costs and benefits 
of the regulatory action to the extent practicable, 15 U.S.C. 2605(a), 
(c)(2). Additionally, the 2016 amendments to TSCA reflect Congressional 
intent to ``delete the paralyzing `least burdensome' requirement,'' 162 
Cong. Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as 
originally enacted, which required EPA to use ``the least burdensome 
requirements'' that protect ``adequately'' against unreasonable risk, 
15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under 
the CPSA must impose ``the least burdensome requirement which prevents 
or adequately reduces the risk of injury for which the rule is being 
promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at 
variance with recent revisions to TSCA, affect the availability of 
action CPSC may take under the Federal Hazardous Substances Act (FHSA) 
relative to action EPA may take under TSCA. 15 U.S.C. 1262.
    EPA therefore concludes that TSCA is the only regulatory authority 
able to prevent or reduce unreasonable risk of PCE to a sufficient 
extent across the range of conditions of use, exposures and populations 
of concern. This unreasonable risk can be addressed in a more 
coordinated, efficient and effective manner under TSCA than under 
different laws implemented by different agencies. Moreover, the 
timeframe and any exposure reduction as a result of updating OSHA or 
CPSC regulations cannot be estimated, while TSCA requires a much more 
accelerated 2-year statutory timeframe for proposing and finalizing 
regulatory requirements to address unreasonable risk. Further, there 
are key differences between the finding requirements of TSCA and those 
of the OSH Act, CPSA, and FHSA. For these reasons, in the 
Administrator's discretion, the Administrator has analyzed this issue 
and does not determine that unreasonable risk from PCE may be prevented 
or reduced to a sufficient extent by an action taken under a Federal 
law not administered by EPA. However, EPA is requesting public comment 
on this issue (i.e., the sufficiency of an action taken under a Federal 
law not administered by EPA).

B. TSCA Section 9(b) Analysis

    If EPA determines that actions under other Federal laws 
administered in whole or in part by EPA could eliminate or sufficiently 
reduce a risk to health or the environment, TSCA section 9(b) instructs 
EPA to use these other authorities to protect against that risk unless 
the Administrator determines in the Administrator's discretion that it 
is in the public interest to protect against such risk under TSCA. In 
making such a public interest finding, TSCA section 9(b)(2) states: 
``the Administrator shall consider, based on information reasonably 
available to the Administrator, all relevant aspects of the risk . . . 
and a comparison of the estimated costs and efficiencies of the action 
to be taken under this title and an action to be taken under such other 
law to protect against such risk.''
    Although several EPA statutes have been used to limit PCE exposure 
(Ref. 6), regulations under those EPA statutes have limitations because 
they largely regulate releases to the environment, rather than 
occupational or consumer exposures. While these limits on releases to 
the environment are protective in the context of their respective 
statutory authorities, regulation under TSCA is also appropriate for 
occupational and consumer exposures and in some cases can provide 
upstream protections that would prevent the need for release 
restrictions required by other EPA statutes (e.g., Resource 
Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)).
    The primary exposures and unreasonable risk to consumers, 
bystanders, workers, and ONUs would be addressed by EPA's proposed 
prohibitions and restrictions under TSCA section 6(a). In contrast, the 
timeframe and any exposure reduction as a result of updating 
regulations for PCE under the CAA, CWA, or RCRA cannot be estimated, 
nor would they address the direct human exposure to consumers, 
bystanders, workers, and ONUs from the conditions of use evaluated in 
the 2020 Risk Evaluation for PCE. More specifically, none of EPA's 
other statutes (e.g., RCRA, CAA, CWA) can address exposures to workers 
and ONUs related to the specific activities that result in occupational 
exposures, for example those associated with RCRA covered disposal 
requirements. EPA therefore concludes that TSCA is the most appropriate 
regulatory authority able to prevent or reduce risks of PCE to a 
sufficient extent across the range of conditions of use, exposures, and 
populations of concern.
    For these reasons, the Administrator does not determine that 
unreasonable risk from PCE under the conditions of use evaluated in the 
2020 TSCA Risk Evaluation for PCE could be eliminated or reduced to a 
sufficient extent by actions taken under other Federal laws 
administered in whole or in part by EPA.

C. TSCA Section 14 Requirements

    EPA is also providing notice to manufacturers, processors, and 
other interested parties about potential impacts to CBI that may occur 
if this rule is finalized as proposed. Under TSCA section 14(b)(4), if 
EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a 
ban or phase-out of a chemical substance, the protection from 
disclosure of any CBI regarding that chemical substance and submitted 
pursuant to TSCA will be ``presumed to no longer apply,'' subject to 
the limitations identified in TSCA section 14(b)(4)(B)(i) through 
(iii). If this rule is finalized as proposed, then pursuant to TSCA 
section 14(b)(4)(B)(iii), the presumption against protection from 
disclosure would apply only to information about the specific 
conditions of use that this rulemaking would prohibit or phase out. 
Manufacturers or processors seeking to protect such information would 
be able to submit a request for nondisclosure as provided by TSCA 
sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure 
would need to be submitted within 30 days after receipt of notice from 
EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such 
notice via the Central Data Exchange or CDX.

D. TSCA Section 26 Considerations

    In accordance with TSCA section 26(h), EPA has used scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, and models consistent with the best available science. 
As in the case of the unreasonable risk determination, risk management 
decisions for this proposed rule, as discussed in Unit III.B.3. and 
Unit V., were based on a risk evaluation that was subject to public 
comment and independent, expert peer review, and was developed in a 
manner consistent with the best available science and based on the 
weight of the scientific evidence as required by TSCA sections 26(h) 
and (i) and 40 CFR 702.43 and 702.45.
    In particular, the ECEL value incorporated into the WCPP and de

[[Page 39706]]

minimis concentration limit are derived from the analysis in the 2020 
Risk Evaluation for PCE; they likewise represent decisions based on the 
best available science and the weight of the scientific evidence (Refs. 
10, 45, 53). The ECEL value of 0.14 ppm as an 8-hour TWA is based on 
the chronic non-cancer HEC for neurotoxicity identified in the 2020 
Risk Evaluation for PCE, which is the concentration at which an adult 
human would be unlikely to suffer adverse effects if exposed for a 
working lifetime, including susceptible subpopulations. As discussed in 
Unit V.A.1., EPA used models from the 2020 Risk Evaluation for PCE to 
derive the proposed de minimis concentration limit, which represents a 
level below which EPA would not expect product use to drive 
unreasonable risk.
    The extent to which the various information, procedures, measures, 
methods, protocols, methodologies or models, as applicable, used in 
EPA's decisions have been subject to independent verification or peer 
review is adequate to justify their use, collectively, in the record 
for this rulemaking. Additional information on the peer review and 
public comment process, such as the peer review plan, the peer review 
report, and the Agency's response to comments, can be found in EPA's 
risk evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0732).

VIII. Requests for Comment

    EPA is requesting public comment on all aspects of this proposal, 
including the proposed and alternative regulatory actions and all 
individual elements of these, and all supporting analysis. 
Additionally, within this proposal, the Agency is soliciting feedback 
from the public on specific issues throughout this proposed rule. For 
ease of review, this section summarizes those specific requests for 
comment.
    1. EPA is requesting public comment on all elements of the proposed 
regulatory action and the alternative regulatory actions.
    2. EPA is requesting public comment regarding the need for 
exemptions from the rule (and under what specific circumstances), 
including exemptions from the proposed regulatory action (e.g., a WCPP) 
and the primary and second alternative regulatory actions, pursuant to 
the provisions of TSCA section 6(g).
    3. EPA requests comment on all elements of the IRFA, and, in 
particular, the flexibilities that EPA has identified following input 
from the SERs during the SBAR process.
    4. EPA requests comment on whether EPA should promulgate 
definitions for the conditions of use covered by the 2020 Risk 
Evaluation for PCE that would not be prohibited, and, if so, whether 
the descriptions in this unit are consistent with the conditions of use 
evaluated in the 2020 Risk Evaluation for PCE and whether they provide 
a sufficient level of detail to improve the clarity and readability of 
the regulation.
    5. EPA requests comment on the impacts, if any, a prohibition on 
the processing of PCE into a formulation, mixture or reaction product 
in other chemical products and preparations, or other aspects of this 
proposal, may have on the production and availability of any pesticide 
or other substance excluded from the TSCA definition of ``chemical 
substance.''
    6. EPA requests comment regarding the number of businesses or other 
entities that could potentially close as well as associated costs with 
a prohibition of PCE for certain industrial and commercial conditions 
of use identified in this unit.
    7. EPA requests comment on the proposed compliance dates for 
prohibitions of PCE manufacturing, processing, distribution in 
commerce, and use and whether additional time is needed, for example, 
for products to clear the channels of trade, or for implementing the 
use of substitutes; comments should include documentation such as the 
specific use of the chemical throughout the supply chain; concrete 
steps taken to identify, test, and qualify substitutes for those uses 
(including details on the substitutes tested and the specific 
certifications that would require updating); and estimates of the time 
required to identify, test, and qualify substitutes with supporting 
documentation. EPA also requests comment on whether these are the 
appropriate types of information for use in evaluating compliance 
requirements, and whether there are other considerations that should 
apply.
    8. EPA requests comment on the amount of time needed, for example, 
for dry cleaners to transition to an alternative process or solvent. 
EPA also requests comment regarding the number of entities that could 
potentially close as well as associated costs with a 10-year phaseout 
of PCE for use in dry cleaning as identified in this unit.
    9. EPA requests comment on allowing a de minimis level of PCE in 
products (i.e., concentrations less than 0.1% by weight) to account for 
impurities.
    10. EPA is soliciting 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.
    11. EPA is requesting comment on issues around the viability of 
current analytical methods and detection limits for occupational 
perchloroethylene sampling and/or monitoring methods.
    12. EPA is soliciting comments regarding the timing of the initial 
exposure monitoring so that it would be representative of all tasks 
involving PCE where exposures may approach the ECEL. EPA is also 
soliciting comments regarding use of area sampling instead of personal 
breathing zone as a representative sample of exposures.
    13. EPA requests comment on the timeframes for periodic monitoring 
outlined in Table 1 of this unit.
    14. EPA is soliciting comment on requiring warning signs to 
demarcate regulated areas, such as the requirements found in OSHA's 
General Industry Standard for Beryllium.
    15. EPA requests comment on available methods to measure the 
effectiveness of engineering and administrative controls in preventing 
or reducing the potential for direct dermal contact to PCE. EPA is also 
requesting comment on available monitoring methods, such as charcoal 
patch testing, as feasible or effective methods to measure potential 
direct dermal contact with PCE.
    16. EPA is requesting comment on whether there should be a 
requirement to replace cartridges or canisters after a certain number 
of hours, such as the requirements found in OSHA's General Industry 
Standard for 1,3-Butadiene, or a requirement for a minimum service life 
of non-powered air-purifying respirators such as the requirements found 
in OSHA's General Industry Standard for Benzene.
    17. EPA is soliciting comments on the requirements proposed for 
appropriate PPE selection, the effectiveness of PPE in preventing 
direct dermal contact with PCE in the workplace, and general absorption 
and permeation effects to PPE from direct dermal exposure. In addition, 
EPA understands that some workplaces rinse and reuse PPE after minimal 
use and is therefore soliciting comments on the impact on effectiveness 
of rinsing and reusing certain types of PPE, either gloves or 
protective clothing and gear. EPA also requests comment on the degree 
to which additional guidance related to use of PPE might be 
appropriate.
    18. EPA is requesting comment on how owners and operators can 
engage with potentially exposed persons on the development and 
implementation of an exposure control plan and PPE program.

[[Page 39707]]

    19. EPA requests comment relative to the ability of owners or 
operators to conduct initial monitoring within 6 months after date of 
publication of the final rule in the Federal Register, and anticipated 
timelines for any procedural adjustments needed to comply with the 
requirements outlined in this unit, including establishment of a 
respiratory protection program and development of an exposure control 
plan. EPA also requests comment relative to the ability of owners or 
operators to implement processes for occupational conditions of use 
which are subject to DDCC requirements within 12 months of publication 
of the final rule in the Federal Register, and anticipated timelines 
for any procedural adjustments needed to comply with the requirements 
outlined in this unit.
    20. EPA requests comment on whether it should incorporate in the 
rule best practices to ensure proper and adequate performance of 
laboratory fume hoods, such as those identified in OSHA's 29 CFR 
1910.1450, Appendix A National Research Council Recommendations 
Concerning Chemical Hygiene in Laboratory. Additionally, EPA requests 
comment relative to the ability of owners or operators to implement 
laboratory chemical fume hood and dermal PPE related requirements 
within 12 months of publication of the final rule, and anticipated 
timelines for any procedural adjustments needed to comply with the 
requirements outlined in this unit.
    21. EPA requests comments on the appropriateness of identified 
compliance timeframes for recordkeeping and downstream notification 
requirements described in this unit.
    22. EPA requests comment on the primary alternative regulatory 
action (a combination of prohibitions, requirements for a WCPP, and 
prescriptive controls) and whether any elements of this primary 
alternative regulatory action described in this unit should be 
considered as EPA develops the final regulatory action. In particular, 
EPA is requesting comment on the likelihood of successful compliance 
with a PCE WCPP, as described in Unit IV.A., for the conditions of use 
listed for the primary alternative regulatory action of PCE WCPP in 
Unit IV.B. Further, EPA is soliciting 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. EPA also requests comment on 
any advantages or drawbacks for the timelines outlined in this unit 
compared to the timelines identified for the proposed regulatory action 
in Unit IV.A.
    23. EPA requests comment on the ways in which PCE may be used in 
the conditions of use for which the primary alternative regulatory 
action would require a WCPP, including whether activities may take 
place in a closed system and the degree to which users of PCE in these 
sectors could successfully implement an ECEL, DDCC, and ancillary 
requirements described in Unit IV.A. For the industrial and commercial 
use in laboratory chemicals, EPA is soliciting comment on non-
prescriptive requirements of an ECEL and DDCC as compared to the 
prescriptive workplace controls of fume hood and dermal PPE EPA is 
proposing in Unit IV.A.3.
    24. Regulated entities would be required to implement an exposure 
control plan within 18 months after date of publication of the final 
rule in the Federal Register. EPA requests comment on any advantages or 
drawbacks for the timelines outlined in this unit compared to the 
timelines identified for the proposed regulatory action in Unit IV.A.
    25. EPA is soliciting comment on prescribing specific dermal PPE, 
such as gloves, for each condition of use that should be considered as 
EPA develops the final regulatory action. Additionally, EPA is 
soliciting comment on prescribing specific respirators or APFs for 
respirators for each condition of use that should be considered as EPA 
develops the final regulatory action.
    26. EPA is requesting comment on specific controls that mitigate 
the unreasonable risk from PCE and that could be included as part of a 
prescriptive workplace controls requirement, which could be considered 
as EPA develops the final regulatory action. Specifically, EPA is 
soliciting comment on combinations of specific engineering controls, 
administrative controls, and PPE that would reduce inhalation exposures 
to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct 
dermal contact with PCE for all workplaces where such controls would be 
required. EPA also is soliciting comment on the extent to which such 
requirements could reduce inhalation exposures to at or below the ECEL 
of 0.014 ppm as an 8-hour TWA. Additionally, EPA is requesting comment 
on the compliance timeframe needed to implement engineering controls, 
administrative controls, and PPE that reduce inhalation exposures to at 
or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal 
contact with PCE for all regulated entities.
    27. EPA requests comment on a combination of the 1% concentration 
limit for adhesives and sealants with specific engineering controls, 
administrative controls, or respiratory protection that would reduce 
inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-
hour TWA. Additionally, EPA is requesting comment on a combination of a 
concentration limit with WCPP requirements. EPA also requests 
monitoring data, formulations used, and detailed descriptions of PCE 
involving activities for the industrial and commercial use in solvent-
based adhesives and sealants to determine whether a concentration limit 
would reduce inhalation exposures such that risks are no longer 
unreasonable.
    28. EPA requests comment on the second alternative regulatory 
action (a combination of prohibition and a WCPP) and whether any 
elements of this second alternative regulatory action described in this 
unit should be considered as EPA develops the final regulatory action. 
EPA also requests comment on any advantages or drawbacks for the 
timelines outlined in this unit compared to the timelines identified 
for the proposed regulatory action in Unit IV.A.
    29. EPA requests comments on all aspects of the section 6(g) 
exemption from the prohibition on industrial and commercial use of PCE 
in maskant for chemical milling as part of the second alternative 
regulatory option, including information on the extent to which the 
industry could meet the requirements of the proposed WCPP or 
prescriptive controls and whether compliance with specific elements of 
the proposed WCPP should also be required during the period of the 
exemption.
    30. EPA requests comments on all aspects of the exemption request 
and proposed exemption from the prohibition on use of PCE in vapor 
degreasing as part of the second alternative regulatory action, 
including information on the extent to which this industry could meet 
the requirements of the proposed WCPP or prescriptive controls and 
whether compliance with specific elements of the proposed WCPP should 
also be required during the period of the exemption.
    31. EPA is requesting comment on whether to consider a regulatory 
alternative that would subject more conditions of use to a WCPP, 
instead of prohibition, than those currently contemplated in the 
primary alternative regulatory action. EPA also requests monitoring 
data and detailed descriptions of PCE involving activities for these 
conditions of use to determine

[[Page 39708]]

whether these additional conditions of use could comply with the WCPP 
such that risks are no longer unreasonable.
    32. EPA is requesting comment on whether vapor degreasing of parts 
and components for non-aerospace applications should also be exempt 
from prohibition as part of the second alternative regulatory action 
for the industrial and commercial use of PCE in vapor degreasing. To 
facilitate EPA's consideration of exemptions for other sectors, 
comments in support of additional exemptions should include detailed 
explanations of why and how long exemptions would be needed.
    33. EPA is soliciting comment on whether it should specify the type 
of vapor degreasing operation, such as closed loop batch vapor 
degreasing, that would be exempt from prohibition as part of the second 
alternative regulatory action for the industrial and commercial use of 
PCE in vapor degreasing for aerospace parts and whether it should 
consider different exemption timeframes for different types of vapor 
degreasing operations.
    34. Each owner or operator would be required to provide respiratory 
protection to all potentially exposed persons in the regulated area 
within 3 months after receipt of the results of any exposure monitoring 
or within 6 months after date of publication of the final rule in the 
Federal Register. Regulated entities would be required to implement an 
exposure control plan within 9 months after date of publication of the 
final rule in the Federal Register. EPA requests comment on any 
advantages or drawbacks for the timelines outlined in this unit 
compared to the timelines identified for the proposed regulatory action 
in Unit IV.A.
    35. EPA is requesting comment on the de minimis concentration limit 
of PCE in products or formulations.
    36. EPA is requesting comment on the extent to which facilities 
engaged in the industrial and commercial use of PCE as a processing aid 
in catalyst regeneration in petrochemical manufacturing may already 
meet the requirements in the proposed and alternative regulatory 
actions described in Unit IV. to address the unreasonable risk and is 
soliciting comment on the impact of such requirements on petroleum 
refining, with special attention to the price of gasoline.
    37. EPA is requesting comment on whether preventing dermal contact 
with PCE through dermal PPE and training would adequately address the 
unreasonable risk from dermal exposures for the industrial and 
commercial use in laboratory chemicals.
    38. EPA is requesting comment on whether to include a self-
certification requirement for purchasing PCE or PCE-containing 
products.
    39. As part of the primary alternative regulatory action, EPA is 
soliciting 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.
    40. EPA is soliciting comments on whether, for those product types 
relevant to industrial, commercial, and consumer conditions of use 
proposed to be prohibited or significantly restricted where EPA was 
unable to identify products currently available for sale that contain 
PCE, there are products in use or available for sale relevant to these 
conditions of use that contain PCE at this time, so that EPA can 
ascertain whether there are alternatives that benefit human health or 
the environment as compared to such use of PCE.
    41. EPA is requesting comment on the Alternatives Assessment as a 
whole.
    42. EPA requests comment on whether owners and operators should be 
required to attest to whether and why the exposure controls they have 
selected would not result in increased air releases of PCE from the 
workplace, and keep records of that statement as part of the WCPP 
exposure control plan.
    43. EPA is requesting comment on the estimated economic impacts to 
the dry cleanining industry, including regarding expected closures.
    44. EPA is requesting public comment on an issue raised in its TSCA 
section 9(a) Analysis (i.e., the sufficiency of an action taken under a 
Federal law not administered by EPA).
    45. EPA requests comments on whether it should incorporate in the 
rule voluntary consensus standards that meet specified performance 
criteria for environmental monitoring or measurement and seeks 
information in support of such comments regarding the availability and 
applicability of voluntary consensus standards that may achieve the 
sampling and analytical requirements of the rule in lieu of the 
proposed approach.
    46. Following Panel report recommendations (Ref. 33) and in 
response to input provided by SERs, EPA is requesting comment on the 
following topics as outlined in the SBAR Panel Report:
     EPA requests public comment on the extent to which a 
regulation under TSCA section 6(a) could minimize requirements, such as 
testing and monitoring protocols, recordkeeping, and reporting 
requirements, which may exceed those already required under OSHA's 
regulations for PCE.
     EPA requests comment on the methodology and inputs for the 
ECEL value that are directly derived from the peer reviewed analysis in 
the December 2020 Risk Evaluation.
     EPA requests comment on reasonable compliance timeframes 
for small businesses.
     EPA requests comment on differing compliance or reporting 
requirements or timetables that account for the resources available to 
small entities.
     EPA requests public comment on specific compliance 
timeframes for the laundry industry.
     EPA requests comment on any additional appropriate factors 
for identifying reasonable compliance timeframes and how to weigh the 
factors for dry cleaning and other industries.
     EPA requests public comment about the feasibility of 
entities complying with and monitoring for a potential ECEL of 0.14 
ppm. Specifically, EPA aims to obtain more information on potential 
costs that could be incurred using strategies to meet the requirements 
of such a standard, such as engineering, administrative, or 
prescriptive controls and how feasible it would be for entities to 
implement these strategies in their operations.
     EPA requests public comment about the feasibility of the 
use of alternatives to PCE and their availability for conditions of use 
that drive the unreasonable risk.
     EPA requests public comment on the consideration for a 
TSCA section 6(g) exemption and alternative compliance timeframes for 
dry cleaning, including information on whether the specific use may be 
critical or essential, why alternatives may not be feasible for this 
condition of use, and the ideal time limit for an exemption.

IX. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not itself physically located in the 
docket. For assistance in locating these other documents, please 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Risk Evaluation for Perchloroethylene. EPA Document #740-R1-
8011. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0058.

[[Page 39709]]

2. EPA. Final Revised Unreasonable Risk Determination for 
Perchloroethylene, Section 5. December 2022.
3. EPA. Economic Analysis of the Proposed Regulation of 
Perchloroethylene. RIN 2070-AK84. June 2023.
4. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last 
Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
5. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16, 
2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
6. EPA. Regulatory Actions Pertaining to Perchloroethylene. 2022.
7. OSHA. Standard Interpretations: 8-hr total weight average (TWA) 
permissible exposure limit (PEL). Accessed January 13, 2023. https://www.osha.gov/laws-regs/standardinterpretations/1995-10-06-3.
8. NIOSH. Hierarchy of Controls. Page last reviewed: August 11, 
2022. https://www.cdc.gov/niosh/topics/hierarchy/.
9. EPA. Perchloroethylene (PCE); Revision to Toxic Substances 
Control Act (TSCA) Risk Determination; Notice of Availability. 
Federal Register (87 FR 76481, December 14, 2022).
10. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational 
Use of Perchloroethylene. April 15, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0023.
11. Cavalleri et al. Perchloroethylene exposure can induce colour 
vision loss. Neuroscience Letters 179: 162-166. August 10, 1994.
12. Echeverria et al. A Behavioral Evaluation of PCE Exposure in 
Patients and Dry Cleaners: A Possible Relationship Between Clinical 
and Preclinical Effects. JOEM Vol. 37, Number 6, 667-680. June 1995.
13. AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992).
14. ACGIH. Supplement: Perchloroethylene. CAS: 127-18-4. Copyright 
1996.
15. EPA. A Review of the Reference Dose and Reference Concentration 
Processes. December 2002. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/88824.
16. Cal/OSHA. Hazard Risk Assessment Project for California: 
Identification of Chemicals of Concern, Possible Risk Assessment 
Methods, and Examples of Health Protective Occupational Air 
Concentrations. December 2007. https://www.cdph.ca.gov/Programs/CCDP,HP/DEODC/OHB/HESIS/CDPH%20Document%20Library/riskreport.pdf.
17. NIOSH. Criteria for a Recommended Standard: Occupational 
Exposure to Tetrachloroethylene (Perchloroethylene). Page last 
reviewed: June 6, 2014. https://www.cdc.gov/niosh/docs/76-185/default.html.
18. NIOSH. NIOSH Pocket Guide to Chemical Hazards: 
Tetrachloroethylene. Page last reviewed: October 30, 2019. https://www.cdc.gov/niosh/npg/npgd0599.html.
19. NIOSH. Appendix A--NIOSH Potential Occupational Carcinogens. 
https://www.cdc.gov/niosh/npg/nengapdxa.html.
20. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register (86 FR 7037, January 25, 2021).
21. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 20, 2021).
22. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register (86 FR 7619, February 1, 2021).
23. EPA. EPA Announces Path Forward for TSCA Chemical Risk 
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
24. SACC. Science Advisory Committee on Chemicals Meeting Minutes 
and Final Report No. 2022-01. March 15-17, 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0415-0095.
25. EPA. Notes from Federalism Consultation on Forthcoming Proposed 
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
Methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
26. EPA. Notes from Tribal Consultations on Forthcoming Proposed 
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE). 
June 15, 2021 and July 8, 2021.
27. Peter Sinsheimer; Green Analytics. Comments on Environmental 
Justice Consultation for TSCA PCE Risk Management of Dry Cleaning. 
August 20, 2021.
28. Hans Kim; AQUA Wet Clean. Letter re: Environmental Justice 
Consultation USEPA TSCA PCE Risk Management. August 20, 2021.
29. W. Heiger-Bernays and G. Nielsen. Comments on Environmental 
Justice Consultation #2 for TCE and PCE. July 5, 2021.
30. Martin Arg[uuml]ello; Physicians for Social Responsibility. 
USEPA EJ Consultation Meeting Comments on PCE and TCE TSCA 
Regulations August 20, 2021.
31. Sa Liu; School of Health Sciences Purdue University. Letter re: 
Environmental Justice Consultation on Forthcoming Proposed 
Rulemakings under TSCA Section 6(a). August 20, 2021.
32. EPA. Notes from Environmental Justice Consultations on 
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and 
Perchloroethylene (PCE). June 16 and July 6, 2021.
33. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA) 
Section 6(a) Perchloroethylene. February 1, 2023.
34. EPA. Initial Regulatory Flexibility Analysis for 
Perchloroethylene; Regulation of Perchloroethylene under TSCA Sec.  
6(a) Proposed Rule; RIN 2070-AK84. June 2023.
35. EPA. Public Webinar on Perchloroethylene: Risk Evaluation and 
Risk Management under TSCA Section 6. January 14, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0002.
36. EPA. Stakeholder Meeting List for Proposed Rulemaking for 
Perchloroethylene under TSCA Section 6(a).
37. EPA. 2021 Policy on Children's Health. October 5, 2021.
38. EPA. Problem Formulation of the Risk Evaluation for 
Perchloroehtylene (Ethene, 1,1,2,2-Tetrachloro). EPA Document #EPA-
740-R1-7017. May 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0732-0080.
39. EPA. Final Risk Evaluation for Perchloroethylene: Supplemental 
File: Releases and Occupational Exposure Assessment. December 2020. 
https://www.regulations.gov/document/EPA-HQ-OAR-2005-0155-0565.
40. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane. 
EPA Document #EPA-740-R-20-005. August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0427-0048.
41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005. 
https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride. 
Federal Register (62 FR 1494, January 10, 1997).
43. Tetrachloroethylene Vapor Monitor (OV-80). https://acsbadge.com/product/tetrachloroethylene-vapor-monitor-ov-80/.
44. OSHA. Recommended Practices for Safety and Health Programs. 
October 2016. https://www.osha.gov/safety-management.
45. EPA. Perchloroethylene (PCE): Risk Management Support Documents. 
November 18, 2022.
46. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
47. National Research Council. Prudent Practices in the Laboratory: 
Handling and Management of Chemical Hazards, Updated Version. 2011. 
https://www.nationalacademies.org/our-work/prudent-practices-in-the-laboratory-an-update.
48. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016.
49. EPA. Meeting with The Chemours Company on Risk Management under 
TSCA Section 6 and Perchloroethylene. February 23, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0008.
50. EPA. Meeting with Honeywell on Risk Management under TSCA 
Section 6 and Perchloroethylene (PCE). March 25, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0018.
51. EPA. Perchloroethylene (PCE): Risk Management Support--PCE 
Adhesive Use. May 24, 2023.
52. EPA. Risk Management for Perchloroethylene Supplemental File: 
Occupational Risk Calculator. CASRN: 127-18-4. December 2021.

[[Page 39710]]

53. EPA. Risk Management for Perchloroethylene Supplemental File: 
Consumer Risk Calculator. CASRN: 127-18-4. March 2021.
54. EPA. Meeting with Spirit AeroSystems on Risk Management under 
TSCA Section 6 and Perchloroethylene (PCE). March 11, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0013.
55. IAMAW. Letter to EPA from International Association of 
Machinists and Aerospace Workers. August 18, 2021.
56. EPA. An Alternatives Assessment for Use of Perchloroethylene RIN 
2070-AK84. November 2022.
57. The Boeing Company. Comments Supporting Request for Additional 
Information on Perchloroethylene (PCE); Rulemaking Under TSCA 
Section 6(a) May 6, 2022.
58. The Boeing Company. Comments Supporting Request for Additional 
Information on Perchloroethylene (PCE); Rulemaking Under TSCA 
Section 6(a). September 23, 2022.
59. NASA. Known Uses of Perchloroethylene. Updated December 14, 
2022.
60. Steve Shestag; The Boeing Company. Information on FAA 
Certification. December 9, 2022.
61. EPA. Meeting with State and Local TSCA Coordination Group on 
Risk Management under TSCA Section 6 for Perchloroethylene. July 11, 
2022.
62. EPA. Meeting with state and local government representatives on 
Risk Management under TSCA Section 6 for Perchloroethylene. June 17, 
2021.
63. EPA. Meeting with Honeywell UOP on Risk Management under TSCA 
Section 6 for Perchloroethylene (PCE) in Petrochemical 
Manufacturing. June 9, 2021.
64. AFPM and API. Comment of the American Fuels & Petrochemical 
Manufacturers and the American Petroleum Institute on Draft Revision 
to Toxic Substances Control Act (TSCA) Risk Determination 
Perchloroethylene. August 1, 2022. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0122.
65. AFPM. AFPM Comments on the Notice--``Problem Formulations for 
the Risk Evaluations To Be Conducted for the First Chemical 
Substances Under the Toxic Substances Control Act, and Application 
of Systematic Review in TSCA Risk Evaluations; Extension of Comment 
Period; Tetrachloroethylene (also known as perchloroethylene)''. 
August 16, 2018. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0108.
66. EPA. Meeting with the American Fuel and Petrochemical 
Manufacturers on Risk Management under TSCA Section 6 for 
Perchloroethylene. July 29, 2021.
67. NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH) 
Publication No. 2005-149. September 2007. https://www.cdc.gov/niosh/npg/default.html.
68. HSIA. Comment letter from the Halogenated Solvents Industry 
Alliance, Inc. on the draft perchloroethylene TSCA risk evaluation. 
July 6, 2020. https://www.regulations.gov/comment/EPA-HQ-OPPT-2019-0502-0053.
69. EPA. Risk Evaluation for Perchloroethylene (Ethylene, 1,1,2,2-
Tetrachloro) Systematic Review Supplemental File: Data Quality 
Evaluation of Environmental Releases and Occupational Exposure. 
CASRN: 127-18-4. April 2020.
70. EPA. Meeting with National Cleaners Association on Risk 
Management under TSCA Section 6 and Perchloroethylene (PCE). January 
28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0006.
71. EPA. Meeting with New York State Department of Environmental 
Conservation on Risk Management under TSCA Section 6 for 
Perchloroethylene. June 10, 2021.
72. EPA. Perchloroethylene: Fenceline Technical Support--Water 
Pathway. October 6, 2022.
73. EPA. Perchloroethylene: Fenceline Technical Support--Air 
Pathway. December 8, 2022.
74. OEJECR. EPA Complaint Nos. 01R-22-R6-, 02R-22-R6, and 04R-22-R6. 
October 12, 2022.
75. EPA. Exposure and Fate Assessment Screening Tool Version 2014 
(E-FAST 2014). Washington, DC: Office of Pollution Prevention and 
Toxics. Last updated: February 17, 2022. https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014.
76. National Water Quality Monitoring Council (NWQMC): Water Quality 
Portal. 2017. https://www.waterqualitydata.us/.
77. William P.L. Carter. Development of the SAPRC-07 Chemical 
Mechanism and Updated Ozone Reactivity Scales. Center for 
Environmental Research and Technology, College of Engineering, 
University of California. Revised January 27, 2010.
78. World Meteorological Organization. Scientific Assessment of 
Ozone Depletion: 2018. Global Ozone Research and Monitoring 
Project--Report No. 58. https://ozone.unep.org/sites/default/files/2019-05/SAP-2018-Assessment-report.pdf.
79. ATSDR. Toxicological Profile for Tetrachloroethylene. June 2019. 
https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=265&tid=48.
80. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of 
Perchloroethylene under TSCA Section 6(a). June 2023.
81. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical 
Methods With Related International Voluntary Consensus Standards. J 
Occup Environ Hyg. 12(7): D107-15. June 11, 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589148/.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action is a ``significant regulatory action'', as defined 
under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 
1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 
2023). Accordingly, EPA submitted this action to OMB for Executive 
Order 12866 review. Documentation of any changes made in response to 
the Executive Order 12866 review is available in the docket. EPA 
prepared an economic analysis (Ref. 3) of the potential costs and 
benefits associated with this action, which is also available in the 
docket and summarized in Unit VI.D.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted to OMB for review and comment under the PRA, 44 U.S.C. 
3501 et seq. The Information Collection Request (ICR) document that EPA 
prepared has been assigned EPA ICR No. 2740.01 (Ref. 80). You can find 
a copy of the ICR in the docket for this proposed rule, and it is 
briefly summarized here.
    There are two primary provisions of the proposed rule that may 
increase burden under the PRA. The first is downstream notification, 
which would be carried out by updates to the relevant SDS and which 
would be required for manufacturers, processors, and distributors in 
commerce of PCE, who would provide notice to companies downstream upon 
shipment of PCE about the prohibitions. The information submitted to 
downstream companies through the SDS would provide knowledge and 
awareness of the restrictions to these companies. The second primary 
provision of the proposed rule that may increase burden under the PRA 
is WCPP-related information generation, recordkeeping, and notification 
requirements (including development of exposure control plans; exposure 
level monitoring and related recordkeeping; development of 
documentation for a PPE program and related recordkeeping; development 
of documentation for a respiratory protection program and related 
recordkeeping; development and notification to potentially exposed 
persons (employees and others in the workplace) about how they can 
access the exposure control plans, exposure monitoring records, PPE 
program

[[Page 39711]]

implementation documentation, and respirator program documentation; and 
development of documentation demonstrating eligibility for an exemption 
from the proposed prohibitions, and related recordkeeping).
    Respondents/affected entities: Persons that manufacture, process, 
use, distribute in commerce, or dispose of PCE or products containing 
PCE. See also Unit I.A.
    Respondent's obligation to respond: Mandatory (TSCA section 6(a) 
and 40 CFR part 751).
    Estimated number of respondents: 12,091.
    Frequency of response: On occasion.
    Total estimated burden: 64,622 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $7,625,325 (per year), includes $2,753,517 
annualized capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. After display in the Federal 
Register when approved, the OMB control numbers for certain EPA 
regulations in title 40 of the CFR are listed in 40 CFR part 9 and 
displayed on the form and instructions or collection portal, as 
applicable.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden to the EPA using the docket identified 
at the beginning of this proposed rule. You may also send your ICR-
related comments to OMB's Office of Information and Regulatory Affairs 
using the interface at https://www.reginfo.gov/public/do/PRAMain. Find 
this particular ICR by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function. OMB must receive 
comments no later than August 15, 2023. EPA will respond to ICR-related 
comments in the final rule.

C. Regulatory Flexibility Act (RFA)

    As required by section 609(b) of the RFA, EPA convened a SBAR Panel 
to obtain advice and recommendations from SERs that potentially would 
be subject to the rule's requirements. The SBAR Panel evaluated the 
assembled materials and small-entity comments on issues related to 
elements of an initial regulatory flexibility analysis (IRFA). A copy 
of the full SBAR Panel Report (Ref. 33) is available in the rulemaking 
docket.
    Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA 
prepared an IRFA (Ref. 34) that examines the impact of the proposed 
rule on small entities along with regulatory alternatives that could 
minimize that impact. The complete IRFA is available for review in the 
docket and is summarized here.
1. Need for the Rule
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines 
after a TSCA section 6(b) risk evaluation that a chemical substance 
presents an unreasonable risk of injury to health or the environment, 
without consideration of costs or other nonrisk factors, including an 
unreasonable risk to a PESS identified as relevant to the risk 
evaluation, under the conditions of use, 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. 
PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A) 
that was issued in December 2020. In addition, in December 2022, EPA 
issued a revised unreasonable risk determination that PCE as a whole 
chemical substance presents an unreasonable risk of injury to health 
under the conditions of use. As a result, EPA is proposing to take 
action to the extent necessary so that PCE no longer presents such 
risk.
2. Objectives and Legal Basis
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA 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 section 6(a) 
to the extent necessary so that the chemical substance or mixture no 
longer presents such risk. EPA has determined through a TSCA section 
6(b) risk evaluation that PCE presents an unreasonable risk under the 
conditions of use.
3. Description and Number of Small Entities to Which the Rule Will 
Apply
    The proposed rule potentially affects small manufacturers 
(including importers), processors, distributors, retailers, users of 
PCE or of products containing PCE, and entities engaging in disposal. 
EPA estimates that the proposal would affect approximately 12,202 small 
entities. Almost half (5,949) of these entities are commercial users of 
PCE in dry cleaning applications. Users of products containing PCE, 
including adhesives and sealants, aerosol cleaners/degreasers, liquid 
cleaners/degreasers, mold cleaners, and other products also account for 
about half of the affected small entities. EPA also estimates that 69 
small entities use PCE in chemical milling, 88 use PCE in recycling and 
disposal, and 30 incorporate PCE into other formulations, mixtures, and 
reaction products.
4. Projected Compliance Requirements
    To address the unreasonable risk EPA has identified, EPA is 
proposing to: prohibit most industrial and commercial uses and the 
manufacture (including import), processing and distribution in 
commerce, of PCE for those uses; prohibit the manufacture (including 
import), processing, and distribution in commerce of PCE for all 
consumer use; prohibit the manufacture (including import), processing, 
distribution in commerce, and use of PCE in dry cleaning and related 
spot cleaning through a 10-year phaseout; require a PCE WCPP, which 
would include requirements to meet an inhalation exposure concentration 
limit and prevent direct dermal contact, for certain conditions of use 
not prohibited; require prescriptive workplace controls for laboratory 
use; and establish recordkeeping and downstream notification 
requirements. There are an estimated 12,189 small entities affected by 
the proposed option with a per firm cost of $715 with a total estimated 
cost impact of $8.7 million. This includes $6.7 million for WCPP uses, 
$1.9 million for uses that are prohibited, and $0.1 million for lab 
uses.
    EPA is proposing to prohibit most conditions of use. For most other 
conditions of use that drive the unreasonable risk determination for 
PCE, EPA proposes to address the unreasonable risk with a PCE WCPP, 
which would include a combination of requirements to address 
unreasonable risk driven by inhalation and dermal exposures in the 
workplace. A PCE WCPP would encompass restrictions on certain 
occupational conditions of use and could include provisions for an 
ECEL, DDCC, and ancillary requirements to support implementation of 
these restrictions. Due to the low exposure level and stringent 
requirements in the PCE WCPP that would be necessary to address the 
unreasonable risk from PCE, EPA identified only a relatively small 
number of conditions of use where the Agency expected a PCE WCPP could 
be successfully implemented.
    As described in Unit IV.A., the PCE WCPP would be non-prescriptive, 
in the sense that regulated entities would not be required to use 
specific controls prescribed by EPA to achieve the

[[Page 39712]]

exposure concentration limit. Rather, it would be a performance-based 
exposure limit that would enable owners or operators to determine how 
to most effectively meet the exposure limit based on conditions at 
their workplace.
    A central component of the PCE WCPP is the exposure limit. 
Exposures remaining at or below the ECEL would address any unreasonable 
risk of injury to health driven by inhalation exposures for 
occupational conditions of use. EPA's proposed requirements include the 
specific exposure limits that would be required to meet the TSCA 
section 6(a) standard to apply one or more requirements to the 
substance so that it no longer presents unreasonable risk, and also 
include ancillary requirements necessary for the ECEL's successful 
implementation as part of a WCPP.
    EPA is not proposing reporting requirements beyond downstream 
notification (third-party notifications). Regarding recordkeeping 
requirements, three primary provisions of the proposed rule relate to 
recordkeeping. The first is recordkeeping of general records: all 
persons who manufacture, process, distribute in commerce, or engage in 
industrial or commercial use of PCE or PCE-containing products must 
maintain ordinary business records, such as invoices and bills-of-
lading related to compliance with the prohibitions, restrictions, and 
other provisions of the regulation.
    The second is recordkeeping related to WCPP compliance: under the 
proposed regulatory action, facilities complying with the rule through 
WCPP would be required to develop and maintain records associated with 
ECEL exposure monitoring (including measurements, compliance with Good 
Laboratory Practice Standards, and information regarding monitoring 
equipment); ECEL compliance (including the exposure control plan, PPE 
program implementation, and workplace information and training); DDCC 
compliance (including the exposure control plan, PPE program 
implementation, basis for specific PPE selection, occurrence and 
duration of direct dermal contact with PCE, and workplace information 
and training); and workplace participation. To support and demonstrate 
compliance, EPA is proposing that each owner or operator of a workplace 
subject to the WCPP retain compliance records for five years.
    EPA is also proposing to require specific prescriptive controls for 
the industrial and commercial use of PCE in laboratory chemicals. To 
reduce exposures in the workplace and address the unreasonable risk of 
injury to health resulting from dermal exposures to PCE identified for 
the industrial and commercial use as a laboratory chemical, EPA is 
proposing to require dermal PPE in combination with comprehensive 
training for tasks particularly related to the use of PCE in a 
laboratory setting for each potentially exposed person to direct dermal 
contact with PCE. Additionally, EPA is proposing to require the use of 
fume hoods in workplaces engaged in the laboratory chemical condition 
of use. To support and demonstrate compliance, EPA is proposing that 
each owner or operator of a laboratory workplace subject to the 
workplace controls for laboratory use requirements retain compliance 
records for five years.
a. Classes of Small Entities Subject to the Compliance Requirements
    The small entities that would be potentially directly regulated by 
this rulemaking are small entities that manufacture (including import), 
process, distribute in commerce, use, or dispose of PCE, including 
retailers of PCE for end-consumer uses.
b. Professional Skills Needed To Comply
    Entities that would be subject to this proposal that manufacture 
(including import), process, or distribute PCE in commerce for consumer 
use would be required to cease under the proposed rule. The entity 
would be required to modify their SDS or develop another way to inform 
their customers of the prohibition on manufacture, processing, and 
distribution of PCE for consumer use. They would also be required to 
maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate compliance with the prohibitions, 
restrictions, and other provisions of this proposed regulation. These 
are all routine business tasks that do not require specialized skills 
or training.
    Entities that use PCE in any industrial and commercial capacity 
that is prohibited would be required to cease under the proposed rule. 
Restriction or prohibition of these uses will likely require the 
implementation of an alternative chemical or the cessation of use of 
PCE in a process or equipment that may require persons with specialized 
skills, such as engineers or other technical experts. Instead of 
developing an alternative method themselves, commercial users of PCE 
may choose to contract with another entity to do so.
    Entities that would be permitted to continue to manufacture, 
process, distribute, use (with the exception for use as a laboratory 
chemical), or dispose of PCE would be required to implement a WCPP and 
would have to meet the provisions of the program for continued use of 
PCE. Entities that would be permitted to continue use of PCE as a 
laboratory chemical would be required to implement prescriptive 
workplace controls for laboratory use and would have to meet the 
provisions of the workplace restrictions for continued use of PCE. A 
transition to a WCPP or prescriptive workplace controls for laboratory 
use may require persons with specialized skills such as an engineer or 
health and safety professional. Instead of implementing the WCPP or 
workplace controls for laboratory use themselves, entities that use PCE 
may choose to contract with another entity to do so. Records would have 
to be maintained for compliance with a WCPP or workplace controls for 
laboratory use, as applicable. While this recording activity itself may 
not require a special skill, the information to be measured and 
recorded may require persons with specialized skills such as an 
industrial hygienist.
5. Relevant Federal Rules
    Because of its health effects, PCE is subject to numerous state, 
Federal, and international regulations restricting and regulating its 
use. The following is a summary of the regulatory actions pertaining to 
PCE; for a full description see appendix A of the 2020 Risk Evaluation 
for PCE and the summary in the docket (Ref. 6).
    EPA has issued numerous rules and notices pertaining to PCE under 
its various authorities. PCE is a hazardous air pollutant under the CAA 
(42 U.S.C. 7412(b)(1)). EPA promulgated NESHAP for a number of source-
specific categories that emit PCE, including dry cleaning (40 CFR part 
63, subpart M) and halogenated solvent cleaning (40 CFR part 63, 
subpart T).
    With this proposed rule under TSCA section 6, certain uses and 
emissions already regulated under these NESHAP would be prohibited 
while other uses would be subject to a WCPP.
    Programs within EPA implementing other environmental statutes, 
including, but not limited to, the RCRA, the Comprehensive 
Environmental Response, Compensation, and Liability Act, the Safe 
Drinking Water Act, and the CWA, classify PCE as a characteristic and 
listed hazardous waste (40 CFR 261.24, 40 CFR 261.31, 40 CFR 261.33), a 
hazardous substance (40 CFR 302.4), a contaminant subject to National 
Primary Drinking Water Regulations (40 CFR 141.61), and a toxic 
pollutant (40 CFR 401.15, 40 CFR part 423, appendix A, 40 CFR 131.36) 
or the

[[Page 39713]]

program requires reportable criteria of releases into the environment 
involving PCE. While TSCA shares equity in the regulation of PCE, EPA 
does not anticipate this rulemaking to duplicate nor conflict with the 
aforementioned programs' classifications and associated rules.
    In addition to EPA actions, PCE is also subject to other Federal 
regulations. Under the OSH Act, OSHA established the PEL for PCE at 100 
ppm as an 8-hour TWA with an acceptable ceiling concentration of 200 
ppm and an acceptable maximum peak above the acceptable ceiling 
concentration for an 8-hour shift of 300 ppm, maximum duration of 5 
minutes in any 3 hours. However, EPA recognizes that the existing PEL 
does not eliminate the unreasonable risk identified by EPA under TSCA, 
and EPA is therefore proposing to apply new, lower exposure thresholds, 
derived from the TSCA 2020 Risk Evaluation for PCE, while aligning with 
existing OSHA requirements where possible. For PCE, this approach would 
eliminate the unreasonable risk driven by certain conditions of use, 
reduce burden for complying with the regulations, and provide the 
familiarity of a pre-existing framework for the regulated community.
    Under the FHSA, visual novelty devices containing PCE are regulated 
by the CPSC (16 CFR 1500.83(a)(31)). Under the FFDCA, the Food and Drug 
Administration regulates PCE in bottled water and set the maximum 
permissible level of PCE in bottled water to 0.005 mg/L (21 CFR 
165.110). Under the Atomic Energy Act, the Department of Energy Worker 
Safety and Health Program requires its contractor employees to use the 
2005 ACGIH TLV for PCE, which is 25 ppm (8-hour TWA) and 100 ppm Short 
Term Exposure Limit. Under the Federal Hazardous Material 
Transportation Act, the Department of Transportation has designated PCE 
as a hazardous material, and there are special requirements for 
marking, labeling, and transporting it (49 CFR part 171, 49 CFR part 
172, 40 CFR 173.202, and 40 CFR 173.242).
6. Significant Alternatives to the Proposed Rule
    EPA analyzed alternative regulatory approaches to identify which 
would be feasible, reduce burden to small businesses, and achieve the 
objective of the statute (i.e., applying one or more requirements 
listed in TSCA section 6(a) to the extent necessary so that the 
chemical substance or mixture no longer presents an unreasonable risk). 
As described in more detail in Unit V., EPA considered several factors, 
in addition to identified unreasonable risk, when selecting among 
possible TSCA section 6(a) requirements. To the extent practicable, EPA 
factored into its decisions: the effects of PCE on health and the 
environment, the magnitude of exposure to PCE of human beings and the 
environment, the benefits of PCE for various uses, and the reasonably 
ascertainable economic consequences of the proposed rule. EPA also 
considered input provided by the SERs in selecting among possible TSCA 
section 6(a) requirements as part of the proposed regulatory action and 
alternative regulatory actions, particularly as it related to dry 
cleaners' compliance timeframes. Overall, EPA expects few dry cleaning 
facility closures because EPA estimates that only about 60 PCE machines 
are expected to be in use at the end of the proposed phaseout period, 
based on SER input and given the age of the machines and the declining 
trend of use. Additionally, as s part of this analysis, EPA 
considered--in addition to prohibition, WCPP, and prescriptive controls 
described earlier--a wide variety of control measures to address the 
unreasonable risk from PCE such as weight fractions and a point-of-sale 
self-certification requirement. EPA's analysis of these risk management 
approaches is detailed in Unit V.A.3. In general, EPA determined that 
these approaches alone would either not be able to address the 
unreasonable risk, or, in the case of a weight fraction limit, would 
result in a product containing so little PCE that it would have the 
effect of a prohibition.
    Weight Fractions: As discussed in Unit V.A.3., EPA considered 
limiting the weight fraction of PCE in industrial/commercial and 
consumer products and conducted an analysis to estimate to what extent 
this would reduce risks from conditions of use that drive the 
unreasonable risk for PCE. EPA determined that the unreasonable risk 
from PCE would not be driven by use of products containing PCE at less 
than 0.1% by weight. Therefore, EPA is proposing a de minimis level for 
products containing PCE at levels of less than 0.1% to account for 
impurities that do not drive the unreasonable risk., as described in 
Unit IV.A.1.d. For most industrial/commercial and consumer conditions 
of use, the weight fraction or concentration identified through this 
modeling that would address the unreasonable risk through inhalation or 
dermal pathways was so low that it was highly unlikely that PCE would 
still serve its functional purpose in the formulation. EPA thus 
concluded that a weight fraction limit would essentially function as a 
prohibition yet with a greater amount of uncertainty regarding 
compliance and no increased benefit to users; it was therefore not a 
preferred option. For the industrial and commercial use in solvent-
based adhesives and sealants, EPA identified several products available 
on the market at concentrations of PCE between 0.1% and 1% by weight in 
the 2020 Risk Evaluation for PCE. As part of the primary alternative 
regulatory action, EPA would set a concentration limit of PCE in 
adhesive and sealant products for industrial and commercial use to 1%, 
as described in Unit IV.B.1.c.
    Point-of-sale self-certification: As discussed in Unit V.A.3., EPA 
also examined the extent to which a point-of-sale self-certification 
requirement in order to purchase and subsequently use PCE would further 
ensure that only facilities able to implement and comply with a WCPP or 
prescriptive controls are able to purchase and use PCE, and self-
certify to that. Under a self-certification requirement, entities would 
submit a self-certification to the distributor or retailer each time 
PCE is purchased. The self-certification would consist of a statement 
indicating that the facility is implementing a WCPP or required 
prescriptive controls to control exposures to PCE; the self-
certification would be signed and presented by a person authorized to 
do so by the facility owner or operator. Copies of the self-
certification would be maintained as records by both the owner or 
operator and the distributor or retailer where PCE was purchased. 
However, because of the number and types of entities where users can 
obtain PCE or PCE-containing products, EPA does not believe the added 
requirement and subsequent burden of a point-of-sale self-certification 
requirement for the use of PCE would be an effective tool for 
preventing facilities that may be unable to comply with the WCPP or 
prescriptive controls of this proposed rulemaking from accessing PCE or 
PCE-containing products. As such, EPA is not proposing a self-
certification requirement as an additional component of the 
requirements for addressing the unreasonable risk of occupational 
exposures to PCE.
    Prescriptive controls: As discussed in Unit V.A.1., EPA considered 
prescriptive controls (i.e., engineering or administrative controls, or 
PPE) and has determined that prescriptive controls may not be able to 
eliminate unreasonable risk for some conditions of use when used in 
isolation. In the 2020 Risk Evaluation for PCE, analysis of 
occupational exposure scenarios (OES) indicated that many conditions of 
use

[[Page 39714]]

still posed risk concerns even with the application of respirators with 
APF 25 or 50. Because of the uncertainty regarding the feasibility of 
exposure reductions through engineering controls alone, EPA determined 
that a PCE WCPP ECEL, which would be accompanied by monitoring 
requirements in tandem with the implementation of engineering controls, 
administrative controls, and/or PPE as elements of the program, as 
appropriate, would more successfully reduce exposure so that the 
unreasonable risk is addressed. Additionally, relying primarily on 
respirators and gloves to reduce exposures does not consider other more 
protective controls in the hierarchy, including elimination, 
substitution, engineering controls, and administrative controls. For 
occupational conditions of use where compliance with the PCE WCPP ECEL 
and DDCC is unlikely to be successful, in most cases prohibitions 
(rather than prescribed controls) would be more appropriate to ensure 
that PCE does not present unreasonable risk under the conditions of 
use. EPA is proposing prescriptive workplace controls for laboratory 
use to codify assumptions made in the 2020 Risk Evaluation for PCE 
regarding the use of fume hoods in laboratory settings and because EPA 
has preliminarily determined that chemically resistant gloves in 
combination with specific activity training for tasks where dermal 
exposure can be expected to occur in laboratory settings would address 
the unreasonable risk resulting from dermal exposures. Additionally, as 
part of the primary alternative regulatory action, EPA includes certain 
prescriptive controls (PPE in combination with monitoring, regulated 
area, and training) for conditions of use for which EPA is proposing 
WCPP as the regulatory action.
    As indicated by this overview, and detailed in Unit V.A, in the 
review of alternatives, EPA determined that some methods either did not 
effectively eliminate the unreasonable risk presented by PCE or, for 
many conditions of use, there was a high degree of uncertainty 
regarding whether compliance with a comprehensive WCPP or prescriptive 
controls would be possible to adequately protect potentially exposed 
persons. The primary alternative regulatory action and second 
regulatory action were considered and found to provide greater 
uncertainty in addressing the unreasonable risk from PCE under the 
conditions of use, resulting in EPA's proposed action. Information on 
the costs and benefits of the proposed and alternative regulatory 
actions is available in Chapters 7 and 8 of the Economic Analysis 
Analysis and analysis on small entity impacts is in Chapter 10 of the 
Economic Analysis.
    EPA considered its authority under TSCA section 6(g) to grant a 
time-limited exemption for conditions of use where compliance with a 
requirement would significantly disrupt the national economy, national 
security, or infrastructure. As described in Units IV.B.2.b. and 
V.A.2., based on reasonably available information, EPA analyzed the 
need for an exemption and has found that a TSCA section 6(g) exemption 
may be warranted under the second alternative regulatory action for the 
industrial and commercial use in maskant for chemical milling and for 
the industrial and commercial use in vapor degreasing if the workplaces 
engaged in those conditions of use cannot meet the requirements of the 
proposed regulatory action (PCE WCPP) or primary alternative regulatory 
action (prescriptive controls) such that those conditions of use would 
no longer drive the unreasonable risk. A section 6(g) exemption may 
mean that the unreasonable risk will not be fully addressed.
    As required under TSCA section 6(c)(2)(C) and detailed in Unit 
V.B., EPA also considered to the extent practicable whether technically 
and economically feasible alternatives that benefit human health or the 
environment, compared to the use so proposed to be prohibited or 
restricted, will be reasonably available as a substitute when the 
proposed prohibition or other restriction takes effect. To that end, in 
addition to the Economic Analysis (Ref. 3), EPA conducted an 
Alternatives Assessment, using reasonably available information (Ref. 
56). For this assessment, EPA identified and analyzed alternatives to 
PCE in products relevant to industrial, commercial, and consumer 
conditions of use. Based on reasonably available information, including 
information submitted by industry, EPA understands viable alternatives 
to PCE may not be available for several conditions of use--for example, 
the industrial and commercial use in vapor degreasing for certain 
applications (Refs. 57, 58)--and considered that information to the 
extent practicable in the development of the regulatory options.
    Regarding timeframes for compliance, as described in Unit IV.A.1, 
2, and 3, the proposed compliance dates incorporate EPA's consideration 
of sustained awareness of risks resulting from PCE exposure as well as 
precedent established by the OSHA standards (62 FR 1494, January 10, 
1997). TSCA requires that EPA propose timeframes that are ``as soon as 
practicable'' under TSCA section 6(d)(1)(B) and 6(d)(1)(D). TSCA 
section 6(d)(1)(C) also requires that EPA specify mandatory compliance 
dates for the start of ban or phase-out requirements ``as soon as 
practicable'' but not later than five years after the promulgation date 
of a rule. In developing the proposed compliance timeframes, including 
for the prohibition and phaseout of PCE in dry cleaning as outlined in 
Unit IV.A.1.c., EPA considered reasonably available information. EPA 
has no information indicating that the proposed compliance dates are 
not practicable for the activities that would be prohibited, or that 
additional time is needed for products affected by the proposed 
restrictions to clear the channels of trade. As noted earlier, EPA is 
seeking public comment on whether additional time is needed for 
compliance with prohibitions, for products to clear the channels of 
trade, or for implementing a WCPP or prescriptive controls. EPA may 
finalize shorter or longer compliance timeframes based on public 
comment. Regarding potential regulatory flexibilities for compliance 
dates and timeframes, EPA notes that the primary alternative regulatory 
action would include longer compliance timeframes for prohibitions. 
Given the potential severity of impacts from exposure to PCE, EPA's 
proposed regulatory action and second alternative regulatory action 
would include relatively rapid compliance timeframes. However, it is 
possible that longer timeframes would be needed for entities to come 
into compliance; therefore, the primary alternative regulatory action 
described in the proposed rule would include longer timeframes for 
implementation than the proposed regulatory action. These timeframes 
are detailed in Unit IV. Information on the estimated costs of the 
shorter and longer timeframes for the dry cleaning phaseout are in 
Chapter 7.7.3 of the Economic Analysis.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The action would 
affect entities that use PCE. It is not expected to affect State, 
local, or Tribal governments because the use of PCE by government 
entities is minimal. This action is not expected to result in 
expenditures by State, local, and Tribal governments, in the

[[Page 39715]]

aggregate, or by the private sector, of $100 million or more (when 
adjusted annually for inflation) in any 1 year. Accordingly, this 
action is not subject to the requirements of sections 202, 203, or 205 
of UMRA.

E. Executive Order 13132: Federalism

    EPA has concluded that this action has federalism implications as 
specified in Executive Order 13132 (64 FR 43255, August 10, 1999), 
because regulations under TSCA section 6(a) may preempt State law. As 
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA 
section 6(a) to address the unreasonable risk presented by a chemical 
substance has the potential to trigger preemption of laws, criminal 
penalties, or administrative actions by a State or political 
subdivision of a State that are: (1) Applicable to the same chemical 
substance as the rule under TSCA section 6(a); and (2) Designed to 
prohibit or otherwise restrict the manufacture, processing, or 
distribution in commerce or use of that same chemical. TSCA section 
18(c)(3) applies that preemption only to the ``hazards, exposures, 
risks, and uses or conditions of use'' of such chemical included in the 
final TSCA section 6(a) rule.
    EPA provides the following preliminary federalism summary impact 
statement. The Agency consulted with State and local officials early in 
the process of developing the proposed action to permit them to have 
meaningful and timely input into its development. This included 
background presentation on September 9, 2020, and a consultation 
meeting on July 22, 2021. EPA invited the following national 
organizations representing State and local elected officials to these 
meetings: American Water Works Association, Association of Clean Water 
Administrators, Association of Metropolitan Water Agencies, Association 
of State Drinking Water Administrators, Environmental Council of the 
States, National Association of Counties, National Conference of State 
Legislatures, National Governors Association, National League of 
Cities, National Water Resources Association, and United States 
Conference of Mayors. During the consultation, stakeholders in 
attendance asked about the differences between PCE and TCE, recommended 
additional reporting requirements as a risk management tool to address 
the unreasonable risk, suggested EPA look into safer alternatives, and 
described concerns related to current impacts on drinking water 
utilities from PCE (Ref. 25). A summary of the meeting with these 
organizations, including the views that they expressed, is available in 
the docket (Ref. 25). EPA provided an opportunity for these 
organizations to provide follow-up comments in writing but did not 
receive any such comments.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have substantial direct effects on Tribal governments, on the 
relationship between the Federal Government and the Indian Tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. This rulemaking would not have 
substantial direct effects on Tribal governments because PCE is not 
manufactured, processed, or distributed in commerce by Tribes. PCE is 
not regulated by Tribes, and this rulemaking would not impose 
substantial direct compliance costs on Tribal governments. Thus, 
Executive Order 13175 does not apply to this action.
    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, EPA consulted with Tribal officials during the 
development of this action. The Agency held a Tribal consultation from 
May 17, 2021, to August 20, 2021, with meetings on June 15, 2021, and 
July 8, 2021. Tribal officials were given the opportunity to 
meaningfully interact with EPA risk managers concerning the current 
status of risk management. During the consultation, EPA discussed risk 
management under TSCA section 6(a), findings from the 2020 Risk 
Evaluation for PCE, types of information to inform risk management, 
principles for transparency during risk management, and types of 
information EPA is seeking from Tribes (Ref. 26). EPA briefed Tribal 
officials on the Agency's risk management considerations and encouraged 
Tribal officials to provide additional comments after the 
teleconferences. Tribal officials raised no related issues or concerns 
to EPA during or in follow-up to those meetings (Ref. 26).

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not a significant regulatory action under 
section 3(f)(1) of Executive Order 12866, and because EPA does not 
believe the environmental health or safety risks addressed by this 
action present a disproportionate risk to children as reflected by the 
conclusions of the PCE risk evaluation. This action's health and risk 
assessments are contained in Unit III.A.3, III.B.2, VI.A. and B., and 
the 2020 Risk Evaluation for PCE and the Economic Analysis for this 
proposed rulemaking (Refs. 1 and 3).

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' under Executive 
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to 
have a significant adverse effect on the supply, distribution or use of 
energy and has not been designated by the Administrator of the Office 
of Information and Regulatory Affairs as a significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

    Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has 
determined that this rulemaking involves environmental monitoring or 
measurement, specifically for occupational inhalation exposures to PCE. 
Consistent with the Agency's Performance Based Measurement System 
(PBMS), the Agency proposes not to require the use of specific, 
prescribed analytic methods. Rather, the Agency plans to allow the use 
of any method that meets the prescribed performance criteria. The PBMS 
approach is intended to be more flexible and cost-effective for the 
regulated community; it is also intended to encourage innovation in 
analytical technology and improved data quality. EPA is not precluding 
the use of any method, whether it constitutes a voluntary consensus 
standard or not, as long as it meets the performance criteria 
specified.
    For this rulemaking, the key consideration for the PBMS approach is 
the ability to accurately detect and measure airborne concentrations of 
PCE at the ECEL and the ECEL action level. Some examples of methods 
which meet the criteria are included in appendix B of the ECEL memo 
(Ref. 10). EPA recognizes that there may be voluntary consensus 
standards that meet the proposed criteria (Ref. 81). EPA requests 
comments on whether it should incorporate such voluntary consensus 
standards in the rule and seeks information in support of such comments 
regarding the availability and applicability of voluntary consensus 
standards that may achieve the sampling and analytical requirements of 
the rule in lieu of the PBMS approach.

[[Page 39716]]

J. Executive Orders 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
Federal agencies, to the greatest extent practicable and permitted by 
law, to make EJ part of their mission by identifying and addressing, as 
appropriate, disproportionately high and adverse human health or 
environmental effects of their programs, policies, and activities on 
minority populations (people of color and/or indigenous peoples) and 
low-income populations.
    EPA believes that the human health or environmental conditions that 
exist prior to this action result in or have the potential to result in 
disproportionately high and adverse human health or environmental 
effects on minority populations, low-income populations and/or 
indigenous peoples. As described more fully in the Economic Analysis, 
EPA conducted an analysis to characterize the baseline conditions faced 
by communities and workers affected by the regulation to identify the 
potential for disproportionate impacts on minority and low-income 
populations. The baseline characterization suggests that workers in 
affected industries and regions, as well as residents of nearby 
communities, are more likely to be people of color than the general 
population in affected states, although this varied by use assessed. 
Additionally, based on reasonably available information, the Agency 
understands that most dry cleaning workers are members of minority 
populations.
    EPA believes that this action is likely to reduce existing 
disproportionate and adverse effects on people of color, low-income 
populations and/or Indigenous peoples. While the regulatory options are 
anticipated to address the unreasonable risk from exposure to PCE to 
the extent necessary so that it is no longer unreasonable, EPA is not 
able to quantify the distribution of the change in risk across affected 
workers, communities, or demographic groups. EPA is also unable to 
quantify the changes in risks to workers, communities, and demographic 
groups from non-PCE-using technologies or practices that firms may 
adopt in response to the regulation to determine whether any such 
changes could pose EJ concerns. Data limitations that prevent EPA from 
conducting a more comprehensive analysis are summarized in the Economic 
Analysis (Ref. 3).
    EPA additionally identified and addressed EJ concerns by conducting 
outreach to advocates of communities that might be subject to 
disproportionate exposure to PCE, such as minority populations, low-
income populations and indigenous peoples. On June 16, 2021, and July 
6, 2021, EPA held public meetings as part of this consultation (Ref. 
32). See also Unit III.A.1. These meetings were held pursuant to and in 
compliance with Executive Order 12898 and Executive Order 14008, 
entitled ``Tackling the Climate Crisis at Home and Abroad'' (86 FR 
7619, February 1, 2021).
    Following the EJ meetings, EPA received five written comments, in 
addition to oral comments provided during the consultations. In 
general, commenters supported strong outreach to affected communities, 
encouraged EPA to follow the hierarchy of controls, favored 
prohibitions, and noted the uncertainty, and in some cases inadequacy, 
of PPE. Commenters also urged the EPA to extend the rulemaking into 
ongoing releases from hazardous waste and disposal sites, in particular 
vapor intrusion of PCE from contaminated groundwater, soil, and indoor 
air. Additionally, commenters expressed concern that the adverse health 
impacts of PCE dry cleaning fall disproportionately to owners and 
employees of minority owned small businesses, noted the viability of 
professional wet cleaning as an alternative to PCE dry cleaning, and 
urged EPA to consider economic impacts and a financial program to 
offset transition costs to local communities.
    The information supporting the review under Executive Order 12898 
is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic 
Analysis (Ref. 3). EPA's presentations and fact sheets for the EJ 
consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of 
the consultation are also available in the public docket for this 
rulemaking (Ref. 32).

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export notification, Hazardous 
substances, Import certification, Reporting and recordkeeping.

Michael S. Regan,
Administrator.

    Therefore, for the reasons stated in the preamble, EPA proposes to 
amend 40 CFR part 751 as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4)

0
2. Amend Sec.  751.5 by adding in alphabetical order definitions for 
``Authorized person'', ``Direct dermal contact'', ``ECEL'', ``Exposure 
group'', ``Owner or operator'', ``Potentially exposed person'', 
``Regulated area'', and ``Retailer'' to read as follows:


Sec.  751.5  Definitions.

* * * * *
    Authorized person means any person specifically authorized by the 
owner or operator to enter, and whose duties require the person to 
enter, a regulated area.
* * * * *
    Direct dermal contact means direct handling of a chemical substance 
or mixture or skin contact with surfaces that may be contaminated with 
a chemical substance or mixture.
    ECEL is an Existing Chemical Exposure Limit and means an airborne 
concentration generally calculated as an eight (8)-hour time-weighted 
average (TWA).
* * * * *
    Exposure group means a group consisting of every person performing 
the same or substantially similar operations in each work shift, in 
each job classification, in each work area where exposure to chemical 
substances or mixtures is reasonably likely to occur.
    Owner or operator means any person who owns, leases, operates, 
controls, or supervises a workplace covered by this part.
* * * * *
    Potentially exposed person means any person who may be 
occupationally exposed to a chemical substance or mixture in a 
workplace as a result of a condition of use of that chemical substance 
or mixture.
    Regulated area means an area established by the regulated entity to 
demarcate areas where airborne concentrations of a specific chemical 
substance exceed, or there is a reasonable possibility they may exceed, 
the ECEL or the EPA Short-Term Exposure Limit (STEL).
    Retailer means a person who distributes in commerce or makes 
available a chemical substance or mixture to consumer end users, 
including e-commerce internet sales or

[[Page 39717]]

distribution. Any distributor with at least one consumer end user 
customer is considered a retailer. A person who distributes in commerce 
or makes available a chemical substance or mixture solely to commercial 
or industrial end users or solely to commercial or industrial 
businesses is not considered a retailer.
0
3. Add subpart G to read as follows:
Subpart G--Perchloroethylene
Sec.
751.601 General.
751.603 Definitions.
751.605 Prohibitions of manufacturing, processing, distribution in 
commerce, and use.
751.607 Workplace Chemical Protection Program.
751.609 Workplace requirements for laboratory use.
751.611 Downstream notification.
751.613 Recordkeeping requirements.
751.615 Exemptions.

Subpart G--Perchloroethylene


Sec.  751.601  General.

    This subpart establishes prohibitions and restrictions on the 
manufacture (including import), processing, distribution in commerce, 
use, and disposal of perchloroethylene (CASRN 127-18-4), also known as 
tetrachloroethylene, to prevent unreasonable risk of injury to health 
in accordance with TSCA section 6(a).


Sec.  751.603  Definitions.

    The definitions in subpart A of this part apply to this subpart 
unless otherwise specified in this section. In addition, the following 
definitions apply:
    Distribute in commerce has the same meaning as in section 3 of the 
Act, except that the term does not include retailers for purposes of 
Sec. Sec.  751.611 and 751.613.
    ECEL action level means a concentration of airborne 
perchloroethylene of 0.07 part per million (ppm) calculated as an eight 
(8)-hour time-weighted average (TWA).
    3rd generation machine means a dry-to-dry machine with a 
refrigerated condenser, as those terms are defined in 40 CFR part 63, 
subpart M.
    4th or 5th generation machine means a dry-to-dry machine with a 
carbon adsorber and refrigerated condenser, as those terms are defined 
in 40 CFR part 63, subpart M.


Sec.  751.605  Prohibitions of manufacturing, processing, distribution 
in commerce, and use.

    (a) Applicability. The provisions of this section apply to the 
following uses as indicated in each paragraph of this section:
    (1) All consumer use, excluding use of clothing and articles that 
have been commercially dry cleaned with perchloroethylene.
    (2) Processing into formulation, mixture or reaction product in 
other chemical products and preparations.
    (3) Dry cleaning use, including:
    (i) Industrial and commercial use in dry cleaning and related spot 
cleaning in 3rd generation machines; and
    (ii) Industrial and commercial use in dry cleaning and related spot 
cleaning in 4th and 5th generation machines.
    (4) All other industrial and commercial use, except for the 
following:
    (i) Those industrial and commercial uses presented in Sec.  
751.607(a);
    (ii) Laboratory use as described in Sec.  751.609(a); and
    (iii) Any industrial and commercial use of clothing and articles 
that have been commercially dry cleaned with perchloroethylene.
    (5) Distribution in commerce.
    (b) Prohibitions. (1) After [DATE 12 MONTHS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are 
prohibited from manufacturing (including importing) perchloroethylene 
for the uses listed in paragraphs (a)(1), (2) and (4) of this section.
    (2) After [DATE 15 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all persons are prohibited from 
processing perchloroethylene, including any perchloroethylene-
containing products, for the uses listed in paragraphs (a)(1), (2) and 
(4) of this section.
    (3) After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all persons are prohibited from 
distributing in commerce (including making available) 
perchloroethylene, including any perchloroethylene-containing products, 
to retailers for any use, other than commercial dry cleaning or 
consumer use of clothing and articles that have been commercially dry 
cleaned with perchloroethylene.
    (4) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all retailers are prohibited from 
distributing in commerce (including making available) 
perchloroethylene, including any perchloroethylene-containing products. 
Distribution in commerce by retailers of clothing and articles that 
have been commercially dry cleaned with perchloroethylene is not 
subject to the prohibitions described in this paragraph.
    (5) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all persons are prohibited from 
distributing in commerce (including making available) 
perchloroethylene, including any perchloroethylene-containing products, 
for the uses described in paragraphs (a)(1) and (4) of this section.
    (6) After [DATE 24 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all persons are prohibited from 
industrial or commercial use of perchloroethylene, including any 
perchloroethylene-containing products, for the uses listed in paragraph 
(a)(4) of this section.
    (7) All persons are prohibited from industrial or commercial use of 
perchloroethylene in dry cleaning machines acquired after [DATE 6 
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL 
REGISTER].
    (8) After [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE 
IN THE FEDERAL REGISTER], all persons are prohibited from industrial or 
commercial use of perchloroethylene for the use listed in paragraph 
(a)(3)(i) of this section.
    (9) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the 
manufacturing (including importing), processing, distribution in 
commerce, or industrial or commercial use of perchloroethylene for dry 
cleaning and spot cleaning, including for the use listed in paragraph 
(a)(3)(ii) of this section.
    (c) De minimis level. Products containing perchloroethylene at 
levels less than 0.1 percent by weight are not subject to the 
prohibitions described in paragraph (b) of this section.


Sec.  751.607  Workplace chemical protection program.

    (a) Applicability. The provisions of this section apply to 
workplaces engaged in the following conditions of use of 
perchloroethylene, unless otherwise indicated in this section, except 
to the extent the conditions of use are prohibited by Sec.  751.605:
    (1) Manufacturing (domestic manufacture);
    (2) Manufacturing (import);
    (3) Processing as a reactant/intermediate;
    (4) Processing into formulation, mixture or reaction product in 
paint and coating products;

[[Page 39718]]

    (5) Processing into formulation, mixture or reaction product in 
cleaning and degreasing products;
    (6) Processing into formulation, mixture or reaction product in 
adhesive and sealant products
    (7) Repackaging;
    (8) Industrial and commercial use as solvent for open-top batch 
vapor degreasing;
    (9) Industrial and commercial use as solvent for closed-loop batch 
vapor degreasing;
    (10) Industrial and commercial use as solvent for in-line 
conveyorized vapor degreasing;
    (11) Industrial and commercial use as solvent for in-line web 
cleaner vapor degreasing;
    (12) Industrial and commercial use in maskant for chemical milling;
    (13) Industrial and commercial use in solvent-based adhesives and 
sealants;
    (14) Industrial and commercial use as a processing aid in catalyst 
regeneration in petrochemical manufacturing;
    (15) Recycling; and
    (16) Disposal.
    (b) Existing chemical exposure limit (ECEL)--(1) Applicability. The 
provisions of this paragraph (b) apply to any workplace engaged in a 
condition of use that is listed in paragraphs (a)(1) through (14) of 
this section and not prohibited by Sec.  751.605.
    (2) Eight-hour time-weighted average (TWA) ECEL. Beginning [DATE 9 
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL 
REGISTER], or beginning 4 months after introduction of 
perchloroethylene into the workplace if perchloroethylene use commences 
after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER], the owner or operator must ensure that no person is 
exposed to an airborne concentration of perchloroethylene in excess of 
0.14 parts of perchloroethylene per million parts of air (0.14 ppm) as 
an eight (8)-hour TWA, in accordance with the requirements of paragraph 
(d)(1)(i) of this section and, if necessary, paragraph (f) of this 
section.
    (3) Exposure monitoring--(i) General. (A) Owners or operators must 
determine each potentially exposed person's exposure by either:
    (1) Taking a personal breathing zone air sample of each potentially 
exposed person's exposure; or
    (2) Taking personal breathing zone air samples that are 
representative of the 8-hour TWA of each person whose exposure must be 
monitored.
    (B) Representative 8-hour TWA exposures must be determined on the 
basis of one or more full-shift exposure of at least one person that 
represents, and does not underestimate, the potential exposure of every 
person in each exposure group and that represents the highest 
perchlorethylene exposures likely to occur under reasonably foreseeable 
conditions of use.
    (C) Exposure samples must be analyzed using an appropriate 
analytical method by a laboratory that complies with the Good 
Laboratory Practice Standards in 40 CFR part 792.
    (D) Owners or operators must ensure that methods used to perform 
exposure monitoring produce results that are accurate, to a confidence 
level of 95 percent, to within plus or minus 25 percent for airborne 
concentrations of perchloroethylene.
    (E) Owners and operators must re-monitor within 15 working days 
after receipt of any exposure monitoring when results indicate 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.
    (ii) Initial monitoring. (A) Each owner or operator who has a 
workplace or work operation covered by this section, except as provided 
for in paragraph (b)(3)(ii)(B) of this section, must perform initial 
monitoring of potentially exposed persons regularly working in areas 
where perchloroethylene is present.
    (B) The initial monitoring required in paragraph (b)(3)(ii)(A) of 
this section must be completed by [DATE 6 MONTHS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or within 30 
days of introduction of perchloroethylene into the workplace, whichever 
is later. Where the owner or operator has monitoring within five years 
prior to [the effective date of the final rule] and the monitoring 
satisfies all other requirements of this section, the owner or operator 
may rely on such earlier monitoring results to satisfy the requirements 
of paragraph (b)(3)(ii)(A) of this section.
    (iii) Periodic monitoring. The owner or operator must establish an 
exposure monitoring program for periodic monitoring of exposure to 
perchloroethylene in accordance with table 1 to this paragraph 
(b)(3)(iii).

 Table 1 to Sec.   751.607(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
      Air concentration condition        Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is    Periodic exposure monitoring is
 below ECEL action level.                 required at least once every
(<0.07 ppm 8-hour TWA).................   five years.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is      required within 3 months of
 above the ECEL (>0.14 ppm 8-hour TWA).   the most recent exposure
                                          monitoring.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is at   required within 6 months of
 or above the ECEL action level but at    the most recent exposure
 or below the ECEL (>=0.07 ppm 8-hour     monitoring.
 TWA, <=0.14 ppm 8-hour TWA).
If the two most recent (non-initial)     Periodic exposure monitoring is
 exposure monitoring measurements,        required within 5 years of the
 taken at least seven days apart within   most recent exposure
 a 6 month period, indicate exposure is   monitoring.
 below the ECEL action level (<0.07 ppm
 8-hour TWA).
If the owner or operator engages in a    The owner or operator may forgo
 condition of use for which WCPP ECEL     the next periodic monitoring
 is required but does not manufacture,    event. However, documentation
 process, use, or dispose of              of cessation of use of
 perchlorethylene in that condition of    perchlorethylene is required;
 use over the entirety of time since      and periodic monitoring would
 the last required monitoring event.      be required when the owner or
                                          operator resumes the condition
                                          of use.
------------------------------------------------------------------------

    (iv) Additional monitoring. (A) The owner or operator must conduct 
additional initial exposure monitoring whenever there has been a change 
in the production, process, control equipment, personnel or work 
practices that may reasonably be expected to result in new or 
additional exposures above the ECEL action level or when the owner or 
operator has any reason to believe that new or additional exposures 
above the ECEL action level have occurred.
    (B) Whenever start-ups, shutdown, spills, leaks, ruptures or other 
breakdowns occur that may lead to

[[Page 39719]]

exposure to potentially exposed persons, the owner or operator must 
conduct additional initial exposure monitoring (using personal 
breathing zone sampling) after the cleanup of the spill or repair of 
the leak, rupture or other breakdown.
    (v) Notification of monitoring results. (A) The owner or operator 
must inform persons whose exposures are represented by the monitoring 
of the monitoring results within 15 working days.
    (B) This notification must include the following:
    (1) Exposure monitoring results;
    (2) Identification and explanation of the ECEL and ECEL action 
level in plain language;
    (3) Explanation of any corresponding required respiratory 
protection as described in paragraph (f) of this section;
    (4) Descriptions of actions taken by the regulated entity to reduce 
exposure to or below the ECEL;
    (5) Quantity of perchloroethylene in use;
    (6) Location of perchloroethylene use;
    (7) Manner of perchloroethylene use;
    (8) Identified releases of perchloroethylene; and
    (9) Whether the airborne concentration of perchloroethylene exceeds 
the ECEL limit.
    (C) Notice must be provided in plain language writing, in a 
language that the person understands, to each potentially exposed 
person or posted in an appropriate and accessible location outside the 
regulated area with an English-language version and a non-English 
language version representing the language of the largest group of 
workers who do not read English.
    (4) Regulated areas. (i) Beginning [DATE 9 MONTHS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or beginning 4 
months after introduction of perchloroethylene into the workplace if 
perchloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or 
operator must establish and maintain a regulated area wherever any 
person's exposure to airborne concentrations of perchloroethylene 
exceeds or can reasonably be expected to exceed the ECEL.
    (ii) The owner or operator must limit access to regulated areas to 
authorized persons.
    (iii) The owner or operator must demarcate regulated areas from the 
rest of the workplace in a manner that adequately establishes and 
alerts persons to the boundaries of the area and minimizes the number 
of authorized persons exposed to perchloroethylene within the regulated 
area.
    (iv) The owner or operator must supply a respirator that complies 
with the requirements of paragraph (f) of this section and must ensure 
that all persons within the regulated area are using the provided 
respirators whenever perchloroethylene exposures may exceed the ECEL.
    (v) An owner or operator who has implemented all feasible 
engineering, work practice and administrative controls as required in 
paragraph (d)(1)(i) of this section, and who has established a 
regulated area as required by paragraph (b)(4)(i) of this section where 
perchloroethylene exposure can be reliably predicted to exceed the ECEL 
only on certain days (for example, because of work or process schedule) 
must have persons use respirators in that regulated area on those days.
    (vi) The owner or operator must ensure that, within a regulated 
area, persons do not engage in non-work activities which may increase 
perchloroethylene exposure.
    (vii) The owner or operator must ensure that while persons are 
wearing respirators in the regulated area, they do not engage in 
activities which interfere with respirator seal or performance.
    (c) Direct dermal contact controls. (1) The provisions of this 
paragraph (c) apply to any workplace engaged in the conditions of use 
that are listed in paragraphs (a)(1) through (16) of this section and 
are not prohibited by Sec.  751.605.
    (2) Owners or operators must ensure that all persons are separated, 
distanced, physically removed, or isolated from direct dermal contact 
with perchloroethylene in accordance with the requirements of paragraph 
(d)(1)(ii) of this section and, if necessary, paragraph (f) of this 
section.
    (d) Exposure control procedures and plan--(1) Methods of 
compliance--(i) ECEL. (A) The owner or operator must institute one or a 
combination of elimination, substitution, engineering controls or 
administrative controls to reduce exposure to or below the ECEL except 
to the extent that the owner or operator can demonstrate that such 
controls are not feasible.
    (B) Wherever the feasible exposure controls, including one or a 
combination of elimination, substitution, engineering controls or 
administrative controls, which can be instituted are not sufficient to 
reduce exposure to or below the ECEL, the owner or operator must use 
them to reduce exposure to the lowest levels achievable by these 
controls and must supplement them by the use of respiratory protection 
that complies with the requirements of paragraph (f) of this section. 
Where an owner or operator cannot demonstrate exposure below the ECEL, 
including through the use of engineering controls or work practices, 
and has not demonstrated that it has supplemented feasible exposure 
controls with respiratory protection that complies with the 
requirements of paragraph (f) of this section, this will constitute a 
failure to comply with the ECEL.
    (C) The owner or operator must maintain the effectiveness of 
engineering controls and administrative controls instituted under 
paragraph (d)(1)(i)(A) of this section.
    (D) The owner or operator must not implement a schedule of 
personnel rotation as a means of compliance with the ECEL.
    (E) The owner or operator must document their exposure control 
strategy and implementation in an exposure control plan in accordance 
with paragraph (d)(2) of this section.
    (ii) Direct dermal contact control requirements. (A) The owner or 
operator must institute one or a combination of elimination, 
substitution, engineering controls, or administrative controls to 
prevent all persons from direct dermal contact with perchloroethylene 
except to the extent that the owner or operator can demonstrate that 
such controls are not feasible.
    (B) Wherever the feasible exposure controls, including one or a 
combination of elimination, substitution, engineering controls or 
administrative controls, which can be instituted are not sufficient to 
prevent direct dermal contact, the owner or operator must use them to 
reduce direct dermal contact to the extent achievable by these controls 
and must supplement them by the use of dermal personal protective 
equipment that complies with the requirements of paragraph (f) of this 
section. Where an owner or operator cannot demonstrate direct dermal 
contact is prevented, including through the use of engineering controls 
or work practices, and has not demonstrated that it has supplemented 
feasible exposure controls with dermal personal protective equipment 
that complies with the requirements of paragraph (f) of this section, 
this will constitute a failure to comply with the direct dermal contact 
control requirements.
    (C) The owner or operator must maintain the effectiveness of 
engineering controls and administrative

[[Page 39720]]

controls instituted under paragraph (d)(1)(ii)(A) of this section.
    (D) The owner or operator must document their exposure control 
strategy and implementation in an exposure control plan in accordance 
with paragraph (d)(2) of this section.
    (2) Exposure control plan requirements. Beginning [DATE 12 MONTHS 
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], 
owners and operators must include and document in an exposure control 
plan the following:
    (i) Identification and rationale of exposure controls used or not 
used in the following sequence: elimination of perchloroethylene, 
substitution of perchloroethylene, engineering controls and 
administrative controls to reduce exposures in the workplace to either 
at or below the ECEL or to the lowest level achievable and to prevent 
or reduce direct dermal contact with perchloroethylene in the 
workplace;
    (ii) The exposure controls selected based on feasibility, 
effectiveness, and other relevant considerations;
    (iii) If exposure controls were not selected, document the efforts 
identifying why these are not feasible, not effective, or otherwise not 
implemented;
    (iv) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training or other steps 
taken;
    (v) Description of any regulated area and how it is demarcated, and 
identification of authorized persons; and description of when the owner 
or operator expects exposures may be likely to exceed the ECEL;
    (vi) Regular inspections, evaluations, and updating of the exposure 
controls to ensure effectiveness and confirmation that all persons are 
implementing them as required;
    (vii) Occurrence and duration of any start-up, shutdown, or 
malfunction of the facility that causes air concentrations to be above 
the ECEL or any direct dermal contact with perchloroethylene and 
subsequent corrective actions taken during start-up, shutdown, or 
malfunctions to mitigate exposures to perchloroethylene; and
    (viii) Availability of the exposure control plan and associated 
records for potentially exposed persons.
    (e) Workplace information and training. (1) The owner or operator 
must provide information and training for each person prior to or at 
the time of initial assignment to a job involving potential exposure to 
perchloroethylene.
    (2) The owner or operator must ensure that information and training 
is presented in a manner that is understandable to each person required 
to be trained.
    (3) The following information and training must be provided to all 
persons assigned to a job involving potential exposure to 
perchloroethylene:
    (i) The requirements of this section, as well as how to access or 
obtain a copy of these requirements in the workplace;
    (ii) The quantity, location, manner of use, release, and storage of 
perchloroethylene and the specific operations in the workplace that 
could result in exposure to perchloroethylene, particularly noting 
where exposures may be above the ECEL or where there is potential for 
direct dermal contact with perchloroethylene;
    (iii) Methods and observations that may be used to detect the 
presence or release of perchloroethylene in the workplace (such as 
monitoring conducted by the owner or operator, continuous monitoring 
devices, visual appearance or odor of perchloroethylene when being 
released, etc.);
    (iv) The health hazards of perchloroethylene in the workplace; and
    (v) The principles of safe use and handling of perchloroethylene 
and measures potentially exposed persons can take to protect themselves 
from perchloroethylene, including specific procedures the owner or 
operator has implemented to protect potentially exposed persons from 
exposure to perchloroethylene, such as appropriate work practices, 
emergency procedures, and personal protective equipment to be used.
    (4) The owner or operator must re-train each potentially exposed 
person annually to ensure that each such person maintains the requisite 
understanding of the principles of safe use and handling of 
perchloroethylene in the workplace.
    (5) Whenever there are workplace changes, such as modifications of 
tasks or procedures or the institution of new tasks or procedures, 
which increase exposure, and where those exposures exceed or can 
reasonably be expected to exceed the ECEL action level or increase 
potential for direct dermal contact, the owner or operator must update 
the training as necessary to ensure that each potentially exposed 
person has the requisite proficiency.
    (f) Personal protective equipment (PPE). (1) The provisions of this 
paragraph (f) apply to any owner or operator that is required to 
provide respiratory protection or dermal protection pursuant to 
paragraph (d)(1)(i)(B) or (d)(1)(ii)(B) of this section or Sec.  
751.609(b)(2).
    (2) PPE, including respiratory and dermal protection, that is of 
safe design and construction for the work to be performed must be 
provided, used, and maintained in a sanitary, reliable, and undamaged 
condition. Owners and operators must select PPE that properly fits each 
affected person and communicate PPE selections to each affected person.
    (3) Owners and operators must provide PPE training in accordance 
with 29 CFR 1910.132(f) to all persons required to use PPE prior to or 
at the time of initial assignment to a job involving potential exposure 
to perchloroethylene. For the purposes of this paragraph (f)(3), 
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply 
equally to potentially exposed persons, and provisions applying to an 
``employer'' also apply equally to owners or operators.
    (4) Owners and operators must retrain each potentially exposed 
person required to use PPE annually or whenever the owner or operator 
has reason to believe that a previously trained person does not have 
the required understanding and skill to properly use PPE, or when 
changes in the workplace or in PPE to be used render the previous 
training obsolete.
    (5) Respiratory protection. (i) Beginning [DATE 9 MONTHS AFTER DATE 
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or within 3 
months after receipt of any exposure monitoring that indicates 
exposures exceeding the ECEL, the owner or operator must supply a 
respirator, selected in accordance with this paragraph, to each person 
who enters a regulated area and must ensure that all persons within the 
regulated area are using the provided respirators whenever 
perchloroethylene exposures may exceed the ECEL.
    (ii) Owners or operators must provide respiratory protection in 
accordance with the provisions outlined in 29 CFR 1910.134(a) through 
(l) (except paragraph (d)(1)(iii)) and as specified in this paragraph 
for persons exposed or who may be exposed to perchloroethylene in 
concentrations above the ECEL. For the purpose of this paragraph (f), 
the maximum use concentration (MUC) as used in 29 CFR 1910.134 must be 
calculated by multiplying the assigned protection factor (APF) 
specified for a respirator by the ECEL. For the purposes of this 
paragraph (f)(5)(ii), provisions in 29 CFR 1910.134(a) through (l) 
(except paragraph (d)(1)(iii)) applying to an ``employee'' also apply 
equally to potentially exposed persons, and

[[Page 39721]]

provisions applying to an ``employer'' also apply equally to owners or 
operators.
    (iii) Owners or operators must select and provide to persons 
appropriate respirators as indicated by the most recent monitoring 
results as follows:
    (A) If the measured exposure concentration is at or below 0.14 ppm: 
no respiratory protection is required.
    (B) If the measured exposure concentration is above 0.14 ppm and 
less than or equal to 0.7 ppm (5 times ECEL): Any National Institute 
for Occupational Safety and Health (NIOSH)-certified air-purifying 
quarter mask respirator (APF 5).
    (C) If the measured exposure concentration is above 0.7 ppm and 
less than or equal to 1.4 ppm (10 times ECEL): Any NIOSH-certified air-
purifying half mask or full facepiece respirator equipped with NIOSH-
approved organic vapor cartridges or canisters (APF 10).
    (D) If the measured exposure concentration is above 1.4 ppm and 
less than or equal to 3.5 ppm (25 times ECEL): Any NIOSH-certified air-
purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; any NIOSH-certified powered air-
purifying respirator equipped with NIOSH-approved organic vapor 
cartridges; or any NIOSH-certified continuous flow supplied air 
respirator equipped with a hood or helmet (APF 25).
    (E) If the measured exposure concentration is above 3.5 ppm and 
less than or equal to 7.0 ppm (50 times ECEL): Any NIOSH-certified air-
purifying full facepiece respirator equipped with NIOSH-approved 
organic vapor cartridges or canisters; or any NIOSH-certified powered 
air-purifying respirator equipped with a tight-fitting facepiece and a 
NIOSH-approved organic vapor cartridge (APF 50).
    (F) If the measured exposure concentration is above 7.0 ppm and 
less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH-certified 
supplied air respirator equipped with a half mask or full facepiece and 
operated in a pressure demand or other positive pressure mode (APF 
1,000).
    (G) If the measured exposure concentration is greater than 140 ppm 
(1,000 times ECEL) or the concentration is unknown: Any NIOSH-certified 
self-contained breathing apparatus equipped with a full facepiece and 
operated in a pressure demand or other positive pressure mode; or any 
NIOSH-certified supplied air respirator equipped with a full facepiece 
and operated in a pressure demand or other positive pressure mode in 
combination with an auxiliary self-contained breathing apparatus 
operated in a pressure demand or other positive pressure mode (APF 
10,000).
    (iv) The respiratory protection requirements in this paragraph 
represent the minimum respiratory protection requirements, such that 
any respirator affording a higher degree of protection than the 
required respirator may be used.
    (v) When a person whose job requires the use of a respirator cannot 
use a negative-pressure respirator, the owner or operator must provide 
that person with a respirator that has less breathing resistance than 
the negative-pressure respirator, such as a powered air-purifying 
respirator or supplied-air respirator, when the person is able to use 
it and if it provides the person with adequate protection.
    (6) Dermal protection. (i) The owner or operator must supply and 
require the donning of dermal PPE that separates and provides a barrier 
to prevent direct dermal contact with perchloroethylene in the specific 
work area where it is selected for use, selected in accordance with 
this paragraph (f)(6)(i) and provided in accordance with 29 CFR 
1910.132(h), to each person who is reasonably likely to be dermally 
exposed in the work area through direct dermal contact with 
perchloroethylene. For the purposes of this paragraph (f)(6)(i), 
provisions in 29 CFR 1910.132(h) applying to an ``employer'' also 
applies equally to owners or operators.
    (ii) Owners or operators must select and provide dermal PPE in 
accordance with 29 CFR 1910.133(b) and additionally as specified in 
this paragraph to each person who is reasonably likely to be dermally 
exposed in the work area through direct dermal contact with 
perchloroethylene. For the purposes of this paragraph (f)(6)(ii), 
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply 
equally to owners or operators.
    (iii) Owners or operators must select and provide to persons 
appropriate dermal PPE based on an evaluation of the performance 
characteristics of the PPE relative to the task(s) to be performed, 
conditions present, and the duration of use. Dermal PPE must include, 
but is not limited to, the following items:
    (A) Impervious gloves selected based on specifications from the 
manufacturer or supplier.
    (B) Impervious clothing covering the exposed areas of the body 
(e.g., long pants, long sleeved shirt).
    (iv) Demonstration of imperviousness. Owners or operators must 
demonstrate that each item of gloves and other clothing selected 
provides an impervious barrier to prevent direct dermal contact with 
perchloroethylene during normal and expected duration and conditions of 
exposure within the work area by evaluating the specifications from the 
manufacturer or supplier of the clothing, or of the material used in 
construction of the clothing, to establish that the clothing will be 
impervious to perchloroethylene alone and in likely combination with 
other chemical substances in the work area.


Sec.  751.609  Workplace requirements for laboratory use.

    (a) Applicability. The provisions of this section apply to 
workplaces engaged in the industrial and commercial use of 
perchloroethylene as a laboratory chemical.
    (b) Laboratory use requirements. (1) After [DATE 12 MONTHS AFTER 
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners 
or operators must ensure fume hoods 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 perchloroethylene is used in a laboratory setting.
    (2) After [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER], owners or operators must ensure that all 
persons reasonably likely to be exposed from direct dermal contact to 
perchloroethylene in a laboratory setting are provided with dermal 
personal protective equipment as outlined in Sec.  751.607(f)(2) and 
(6) and training on proper use of PPE as outlined in Sec.  
751.607(f)(3) and (4).


Sec.  751.611  Downstream notification.

    (a) Beginning on [DATE 2 MONTHS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE FEDERAL REGISTER], each person who manufactures 
(including imports) perchloroethylene for any use must, prior to or 
concurrent with the shipment, notify companies to whom 
perchloroethylene is shipped, in writing, of the restrictions described 
in this subpart in accordance with paragraph (c) of this section.
    (b) Beginning on [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE FEDERAL REGISTER], each person who processes or 
distributes in commerce perchloroethylene or any perchloroethylene-
containing products for any use must, prior to or concurrent

[[Page 39722]]

with the shipment, notify companies to whom perchloroethylene is 
shipped, in writing, of the restrictions described in this subpart in 
accordance with paragraph (c) of this section.
    (c) The notification required under paragraphs (a) and (b) of this 
section must occur by inserting the following text in section 1(c) and 
15 of the Safety Data Sheet (SDS) provided with the perchloroethylene 
or with any perchloroethylene-containing product:

    After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL 
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be 
distributed in commerce to retailers for any use. After [DATE 21 
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL 
REGISTER], this chemical/product is and can only be distributed in 
commerce or processed for the following purposes: Processing as a 
reactant/intermediate; Processing into formulation, mixture or 
reaction product in cleaning and vapor degreasing products; 
Processing into formulation, mixture or reaction product in paint 
and coating products; Processing into formulation, mixture or 
reaction product in adhesive and sealant products; Processing by 
repackaging; Recycling; Industrial and commercial use as solvent in 
vapor degreasing; Industrial and commercial use in maskant for 
chemical milling; Industrial and commercial use as a processing aid 
in catalyst regeneration in petrochemical manufacturing; Industrial 
and commercial use in laboratory chemicals; Industrial and 
commercial use in solvent-based adhesives and sealants; Industrial 
and commercial use in dry cleaning in 3rd generation machines until 
[DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER]; Industrial and commercial use in all dry cleaning 
and related spot cleaning until [DATE 10 YEARS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; and 
Disposal.

Sec.  751.613  Recordkeeping requirements.

    (a) General records. After [DATE 60 DAYS AFTER DATE OF PUBLICATION 
OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons who 
manufacture, process, distribute in commerce, or engage in industrial 
or commercial use of perchloroethylene or perchloroethylene-containing 
products must maintain ordinary business records, such as downstream 
notifications, invoices and bills-of-lading related to compliance with 
the prohibitions, restrictions, and other provisions of this subpart.
    (b) Workplace Chemical Protection Program compliance. (1) ECEL 
exposure monitoring. For each monitoring event, owners or operators 
subject to the ECEL described in Sec.  751.607(b) must document the 
following:
    (i) Dates, duration, and results of each sample taken;
    (ii) All measurements that may be necessary to determine the 
conditions that may affect the monitoring results;
    (iii) Name, workplace address, work shift, job classification, and 
work area of the person monitored; documentation of all potentially 
exposed persons whose exposures the monitoring is intended to represent 
if using a representative sample; and type of respiratory protective 
device worn by the monitored person, if any
    (iv) Use of appropriate sampling and analytical methods, such as 
analytical methods already approved by EPA, Occupational Safety and 
Health Administration (OSHA) or NIOSH, or compliance with an analytical 
method verification procedure;
    (v) Compliance with the Good Laboratory Practice Standards in 
accordance with 40 CFR part 792; and
    (vi) Information regarding air monitoring equipment, including: 
type, maintenance, calibrations, performance tests, limits of 
detection, and any malfunctions.
    (2) ECEL compliance. Owners or operators subject to the ECEL 
described in Sec.  751.607(b) must retain records of:
    (i) Exposure control plan as described in Sec.  751.607(d)(2);
    (ii) Facility exposure monitoring records;
    (iii) Notifications of exposure monitoring results;
    (iv) The name, workplace address, work shift, job classification, 
work area and respiratory protection used by each potentially exposed 
person and PPE program implementation as described in Sec.  751.607(f), 
including fit-testing and training; and
    (v) Information and training provided by the regulated entity to 
each person prior to or at the time of initial assignment to a job 
involving potential exposure to perchloroethylene and any re-training 
as required in Sec.  751.607(e).
    (3) DDCC compliance. Owners or operators subject to DDCC 
requirements described in Sec.  751.607(c) must retain records of:
    (i) Exposure control plan as described in Sec.  751.607(d);
    (ii) Dermal protection used by each potentially exposed person and 
PPE program implementation as described in Sec.  751.607(f), including:
    (A) The name, workplace address, work shift, job classification, 
and work area of each person reasonably likely to directly handle 
perchloroethylene or handle equipment or materials on which 
perchloroethylene may present and the type of PPE selected to be worn 
by each of these persons;
    (B) The basis for specific PPE selection (e.g., demonstration based 
on permeation testing or manufacturer specifications that each item of 
PPE selected provides an impervious barrier to prevent exposure during 
expected duration and conditions of exposure, including the likely 
combinations of chemical substances to which the PPE may be exposed in 
the work area);
    (C) Appropriately sized PPE and training on proper application, 
wear, and removal of PPE, and proper care/disposal of PPE;
    (D) Occurrence and duration of any direct dermal contact with 
perchloroethylene that occurs during any activity or malfunction at the 
workplace that causes direct dermal exposures to occur and/or glove 
breakthrough, and corrective actions to be taken during and immediately 
following that activity or malfunction to prevent direct dermal contact 
to perchloroethylene; and
    (E) Training in accordance with Sec.  751.607(f)(3).
    (iii) Information and training provided by the regulated entity to 
each person prior to or at the time of initial assignment to a job 
involving potential direct dermal contact with perchloroethylene and 
any re-training as required in Sec.  751.607(e).
    (4) Workplace participation. Owners or operators must document the 
notice to and ability of any potentially exposed person that may 
reasonably be affected by perchloroethylene inhalation exposure or 
direct dermal contact to readily access the exposure control plans, 
facility exposure monitoring records, PPE program implementation, or 
any other information relevant to perchloroethylene exposure in the 
workplace.
    (c) Workplace requirements for laboratory use compliance. Owners 
and operators subject to the laboratory chemical requirements described 
in Sec.  751.609 must retain records of:
    (1) Dermal protection used by each potentially exposed person and 
PPE program implementation, as described in Sec.  751.613(b)(3)(ii); 
and
    (2) Documentation identifying: implementation of a properly 
functioning fume hood using manufacturer's instructions for 
installation, use, and maintenance of the fume hood, including 
inspections, tests, development of maintenance procedures, the 
establishment of criteria for acceptable test results, and 
documentation of test and inspection results.
    (d) Records related to Sec.  751.615 exemptions. To maintain 
eligibility for an exemption described in Sec.  751.615,

[[Page 39723]]

the records maintained by the owners or operators must demonstrate 
compliance with the specific conditions of the exemption.
    (e) Retention. Owners or operators must retain the records required 
under this section for a period of 5 years from the date that such 
records were generated.


Sec.  751.615  Exemptions.

    (a) In general. (1) As provided in paragraph (b) of this section, a 
time-limited exemption from the requirements of Sec.  751.605 is 
established in this section in accordance with 15 U.S.C. 2605(g)(1)(A).
    (2) In order to be eligible for the exemptions established in this 
section, regulated parties must comply with all conditions established 
for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
    (b) Time-limited exemption. Use of perchloroethylene or 
perchloroethylene containing products identified in paragraph (b)(1) of 
this section in an emergency by the National Aeronautics and Space 
Administration and its contractors operating within the scope of their 
contracted work until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE 
FINAL RULE IN THE FEDERAL REGISTER].
    (1) Applicability. The emergency use exemption described in this 
paragraph (b) shall apply to the following specific conditions of use 
as described in paragraph (b)(1)(i) of this section.
    (i) Conditions of use subject to this exemption. (A) Industrial and 
commercial use as solvent for cold cleaning.
    (B) Industrial and commercial use in wipe cleaning.
    (ii) Emergency use--(A) In general. An emergency is a serious and 
sudden situation requiring immediate action, within 15 days or less, 
necessary to protect:
    (1) Safety of National Aeronautics and Space Administration's or 
their contractors' personnel;
    (2) National Aeronautics and Space Administration's missions;
    (3) Human health, safety, or property, including that of adjacent 
communities; or
    (4) The environment.
    (B) Duration. Each emergency is a separate situation; if use of 
perchloroethylene exceeds 15 days, then justification must be 
documented.
    (C) Eligibility. To be eligible for the exemption, the National 
Aeronautics and Space Administration and its contractors must:
    (1) Select perchloroethylene because there are no technically and 
economically feasible safer alternatives available during the 
emergency.
    (2) Perform the emergency use of perchloroethylene at locations 
controlled by National Aeronautics and Space Administration or its 
contractors.
    (2) Requirements. To be eligible for the emergency use exemption 
described in this paragraph (b), the National Aeronautics and Space 
Administration and its contractors must comply with the following 
conditions:
    (i) Notification. Within 15 working days of the emergency use by 
National Aeronautics and Space Administration and its contractors, 
National Aeronautics and Space Administration must provide notice to 
EPA that includes the following:
    (A) Identification of the conditions of use detailed in paragraph 
(b)(1)(i) of this section that the emergency use fell under;
    (B) An explanation for why the emergency use met the definition of 
emergency in paragraph (b)(1)(ii)(A) of this section; and
    (C) An explanation of why perchloroethylene was selected, including 
why there were no technically and economically feasible safer 
alternatives available in the particular emergency.
    (ii) Exposure control. The owner or operator must comply with the 
Workplace Chemical Protection Program provisions in Sec.  751.607, to 
the extent technically feasible in light of the particular emergency.
    (iii) Recordkeeping. The owner or operator of the location where 
the use takes place must comply with the recordkeeping requirements in 
Sec.  751.613.

[FR Doc. 2023-12495 Filed 6-15-23; 8:45 am]
BILLING CODE 6560-50-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.