Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA)

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0642; FRL-8317-01-OCSPP]

RIN 2070-AK83

Trichloroethylene (TCE); 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 trichloroethylene (TCE) under its conditions of use as documented in EPA's November 2020 Risk Evaluation for TCE and January 2023 revised risk determination for TCE pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used as a solvent in a variety of industrial, commercial and consumer applications including for hydrofluorocarbon (HFC) production, vapor and aerosol degreasing, and in lubricants, greases, adhesives, and sealants. TSCA requires that when EPA determines a chemical substance presents unreasonable risk that EPA address by rule the unreasonable risk of injury to health or the environment and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. EPA determined that TCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to TCE, including non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, immunotoxicity, reproductive toxicity, and developmental toxicity) as well as cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic inhalation and dermal exposures to TCE. TCE is a neurotoxicant and is carcinogenic to humans by all routes of exposure. The most sensitive adverse effects of TCE exposure are non-cancer effects (developmental toxicity and immunosuppression) for acute exposures and developmental toxicity and autoimmunity for chronic exposures. To address the identified unreasonable risk, EPA is proposing to: prohibit all manufacture (including import), processing, and distribution in commerce of TCE and industrial and commercial use of TCE for all uses, with longer compliance timeframes and workplace controls for certain processing and industrial and commercial uses (including proposed phaseouts and time-limited exemptions); prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works, with a time-limited exemption for cleanup projects; and establish recordkeeping and downstream notification requirements.

DATES:

Comments must be received on or before December 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 November 30, 2023.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0465, 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:

Gabriela Rossner, 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) 565-2426; email address:

TCE.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:

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 TCE or products containing TCE. 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);

• Fossil Fuel Electric Power Generation (NAICS code 221112);

• Other Electric Power Generation (NAICS code 221118);

• Broadwoven Fabric Mills (NAICS code 313210);

• Narrow Fabric Mills and Schiffli Machine Embroidery (NAICS code 313220);

• Nonwoven Fabric Mills (NAICS code 313230);

• Textile and Fabric Finishing Mills (NAICS code 313310);

• Fabric Coating Mills (NAICS code 313320);

• Wood Window and Door Manufacturing (NAICS code 321911);

• Prefabricated Wood Building Manufacturing (NAICS code 321992);

• Paper Bag and Coated and Treated Paper Manufacturing (NAICS code 322220);

• Petroleum Refineries (NAICS code 324110);

• All Other Petroleum and Coal Products Manufacturing (NAICS code 324199);

• Petrochemical Manufacturing (NAICS code 325110);

• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180);

• Ethyl Alcohol Manufacturing (NAICS code 325193);

• All Other Basic Organic Chemical Manufacturing (NAICS code 325199);

• Plastics Material and Resin Manufacturing (NAICS code 325211);

• Medicinal and Botanical Manufacturing (NAICS code 325411);

• Pharmaceutical Preparation Manufacturing (NAICS code 325412);

• Paint and Coating Manufacturing (NAICS code 325510);

• Adhesive Manufacturing (NAICS code 325520);

• Polish and Other Sanitation Good Manufacturing (NAICS code 325612);

• Photographic Film, Paper, Plate and Chemical Manufacturing (NAICS code 325992);

• All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998);

• Polystyrene Foam Product Manufacturing (NAICS code 326140);

• Urethane and Other Foam Product (except Polystyrene) Manufacturing (NAICS code 326150);

• Tire Manufacturing (except Retreading) (NAICS code 326211);

• Tire Retreading (NAICS code 326212);

• Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220);

• Rubber Product Manufacturing for Mechanical Use (NAICS code 326291);

• All Other Rubber Product Manufacturing (NAICS code 326299);

• Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS code 327110);

• Gypsum Product Manufacturing (NAICS code 327420);

• Iron and Steel Mills and Ferroalloy Manufacturing (NAICS code 331110);

• Iron and Steel Pipe and Tube Manufacturing from Purchased Steel (NAICS code 331210);

• Rolled Steel Shape Manufacturing (NAICS code 331221);

• Steel Wire Drawing (NAICS code 331222);

• Nonferrous Metal (except Aluminum) Smelting and Refining (NAICS code 331410);

• Copper Rolling, Drawing, Extruding, and Alloying (NAICS code.331420);

• Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing and Extruding (NAICS code 331491);

• Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and Aluminum) (NAICS code 331492);

• Nonferrous Metal Die-Casting Foundries (NAICS code 331523);

• Iron and Steel Forging (NAICS code 332111);

• Nonferrous Forging (NAICS code 332112);

• Custom Roll Forming (NAICS code 332114);

• Powder Metallurgy Part Manufacturing (NAICS code 332117);

• 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);

• Metal Window and Door Manufacturing (NAICS code 332321);

• Sheet Metal Work Manufacturing (NAICS code 332322);

• Ornamental and Architectural Metal Work Manufacturing (NAICS code 332323);

• Power Boiler and Heat Exchanger Manufacturing (NAICS code 332410);

• Metal Tank (Heavy Gauge) Manufacturing (NAICS code 332420);

• Metal Can Manufacturing (NAICS code 332431);

• Other Metal Container Manufacturing (NAICS code 332439);

• Hardware Manufacturing (NAICS code 332510);

• Spring Manufacturing (NAICS code 332613);

• Other Fabricated Wire Product Manufacturing (NAICS code 332618);

• Machine Shops (NAICS code 332710);

• Precision Turned Product Manufacturing (NAICS code 332721);

• Bolt, Nut, Screw, Rivet and Washer Manufacturing (NAICS code 332722);

• 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);

• Farm Machinery and Equipment Manufacturing (NAICS code 333111);

• Lawn and Garden Tractor and Home Lawn and Garden Equipment Manufacturing (NAICS code 333112);

• Construction Machinery Manufacturing (NAICS code 333120);

• Mining Machinery and Equipment Manufacturing (NAICS code 333131);

• Oil and Gas Field Machinery and Equipment Manufacturing (NAICS code 333132);

• Food Product Machinery Manufacturing (NAICS code 333241);

• Semiconductor Machinery Manufacturing (NAICS code 333242);

• Sawmill, Woodworking, and Paper Machinery Manufacturing (NAICS code 333243);

• Printing Machinery and Equipment Manufacturing (NAICS code 333244);

• Other Industrial Machinery Manufacturing (NAICS code 333249);

• Optical Instrument and Lens Manufacturing (NAICS code 333314);

• Photographic and Photocopying Equipment Manufacturing (NAICS code 333316);

• Other Commercial and Service Industry Machinery Manufacturing (NAICS code 333318);

• Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing (NAICS code 333413);

• Heating Equipment (except Warm Air Furnaces) Manufacturing (NAICS code 333414);

• Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS code 333415);

• Industrial Mold Manufacturing (NAICS code 333511);

• Special Die and Tool, Die Set, Jig and Fixture Manufacturing (NAICS code 333514);

• Cutting Tool and Machine Tool Accessory Manufacturing (NAICS code 333515);

• Machine Tool Manufacturing (NAICS code 333517);

• Rolling Mill and Other Metalworking Machinery Manufacturing (NAICS code 333519);

• Turbine and Turbine Generator Set Unit Manufacturing (NAICS code 333611);

• Speed Changer, Industrial High-Speed Drive and Gear Manufacturing (NAICS code 333612);

• Mechanical Power Transmission Equipment Manufacturing (NAICS code 333613);

• Other Engine Equipment Manufacturing (NAICS code 333618);

• Air and Gas Compressor Manufacturing (NAICS code 333912);

• Measuring, Dispensing, and Other Pumping Equipment Manufacturing (NAICS code 333914);

• Elevator and Moving Stairway Manufacturing (NAICS code 333921);

• Conveyor and Conveying Equipment Manufacturing (NAICS code 333922);

• Overhead Traveling Crane, Hoist and Monorail System Manufacturing (NAICS code 333923);

• Industrial Truck, Tractor, Trailer and Stacker Machinery Manufacturing (NAICS code 333924);

• Power-Driven Hand Tool Manufacturing (NAICS code 333991);

• 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);

• Scale and Balance Manufacturing (NAICS code 333997);

• All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS code 333999);

• Audio and Video Equipment Manufacturing (NAICS code 334310);

• Capacitor, Resistor, Coil, Transformer, and Other Inductor Manufacturing (NAICS code 334416);

• Electronic Connector Manufacturing (NAICS code 334417);

• Printed Circuit Assembly (Electronic Assembly) Manufacturing (NAICS code 334418);

• Other Electronic Component Manufacturing (NAICS code 334419);

• Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing (NAICS code 334511);

• Automatic Environmental Control Manufacturing for Residential, Commercial and Appliance Use (NAICS code 334512);

• Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS code 334513);

• Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals (NAICS code 334515);

• Electric Lamp Bulb and Part Manufacturing (NAICS code 335110);

• Residential Electric Lighting Fixture Manufacturing (NAICS code 335121);

• Commercial, Industrial and Institutional Electric Lighting Fixture Manufacturing (NAICS code 335122);

• Other Lighting Equipment Manufacturing (NAICS code 335129);

• Major Household Appliance Manufacturing (NAICS code 335220);

• Power, Distribution and Specialty Transformer Manufacturing (NAICS code 335311);

• Motor and Generator Manufacturing (NAICS code 335312);

• Switchgear and Switchboard Apparatus Manufacturing (NAICS code 335313);

• Relay and Industrial Control Manufacturing (NAICS code 335314);

• Storage Battery Manufacturing (NAICS code 335911);

• Fiber Optic Cable Manufacturing (NAICS code 335921);

• Current-Carrying Wiring Device Manufacturing (NAICS code 335931);

• Carbon and Graphite Product Manufacturing (NAICS code 335991);

• Automobile Manufacturing (NAICS code 336111);

• Light Truck and Utility Vehicle Manufacturing (NAICS code 336112);

• Heavy Duty Truck Manufacturing (NAICS code 336120);

• Motor Vehicle Body Manufacturing (NAICS code 336211);

• Truck Trailer Manufacturing (NAICS code 336212);

• Motor Home Manufacturing (NAICS code 336213);

• Travel Trailer and Camper Manufacturing (NAICS code 336214);

• Motor Vehicle Gasoline Engine and Engine Parts Manufacturing (NAICS code 336310);

• Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS code 336320);

• Motor Vehicle Steering and Suspension Components (except Spring) Manufacturing (NAICS code 336330);

• Motor Vehicle Brake System Manufacturing (NAICS code 336340);

• Motor Vehicle Transmission and Power Train Parts Manufacturing (NAICS code 336350);

• Motor Vehicle Seating and Interior Trim Manufacturing (NAICS code 336360);

• Motor Vehicle Metal Stamping (NAICS code 336370);

• Other Motor Vehicle Parts Manufacturing (NAICS code 336390);

• Aircraft Manufacturing (NAICS code 336411);

• Aircraft Engine and Engine Parts Manufacturing (NAICS code 336412);

• Other Aircraft Part 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);

• Railroad Rolling Stock Manufacturing (NAICS code 336510);

• Ship Building and Repairing (NAICS code 336611);

• Boat Building (NAICS code 336612);

• Motorcycle, Bicycle and Parts Manufacturing (NAICS code 336991);

• Military Armored Vehicle, Tank and Tank Component Manufacturing (NAICS code 336992);

• All Other Transportation Equipment Manufacturing (NAICS code 336999);

• Wood Kitchen Cabinet and Counter Top Manufacturing (NAICS code 337110);

• Upholstered Household Furniture Manufacturing (NAICS code 337121);

• Nonupholstered Wood Household Furniture Manufacturing (NAICS code 337122);

• Metal Household Furniture Manufacturing (NAICS code 337124);

• Institutional Furniture Manufacturing (NAICS code 337127);

• Wood Office Furniture Manufacturing (NAICS code 337211);

• Surgical Appliance and Supplies Manufacturing (NAICS code 339113);

• Dental Equipment and Supplies Manufacturing (NAICS code 339114);

• Jewelry and Silverware Manufacturing (NAICS code 339910);

• Sporting and Athletic Goods Manufacturing (NAICS code 339920);

• Gasket, Packing, and Sealing Device Manufacturing (NAICS code 339991);

• Fastener, Button, Needle and Pin Manufacturing (NAICS code 339993);

• All Other Miscellaneous Manufacturing (NAICS code 339999);

• Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510);

• Industrial Supplies Merchant Wholesalers (NAICS code 423510);

• Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690);

• Paint, Varnish, and Supplies Merchant Wholesalers (NAICS code 424950);

• New Car Dealers (NAICS code 441110);

• Used Car Dealers (NAICS code 441120);

• Sporting Goods Stores (NAICS code 451110);

• Scheduled Passenger Air Transportation (NAICS code 481111);

• Other Support Activities for Air Transportation (NAICS code 481111);

• Other Warehousing and Storage (NAICS code 493190);

• Motion Picture and Video Production (NAICS code 512110);

• Other Financial Vehicles (NAICS code 525990);

• Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (NAICS code 541715);

• Research and Development in the Social Sciences and Humanities (NAICS code 541720);

• Offices of Other Holding Companies (NAICS code 551112);

• Carpet and Upholstery Cleaning Services (NAICS code 561740);

• Hazardous Waste Treatment and Disposal (NAICS code 562211);

• Solid Waste Landfill (NAICS code 562212);

• Materials Recovery Facilities (NAICS code 562920);

• Junior Colleges (NAICS code 611210);

• Colleges, Universities and Professional Schools (NAICS code 611310);

• 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);

• Coin-Operated Laundries and Drycleaners (NAICS code 812310);

• Drycleaning and Laundry Services (except Coin-Operated) (NAICS code 812320); and

• 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 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 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 TCE 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 TCE by EPA, under the conditions of use (Refs. 1, 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 EPA evaluated in reaching its determination that TCE presents an unreasonable risk is included in Unit III.B.1. EPA notes that all TSCA conditions of use of TCE are subject to this proposal. Accordingly, to address the unreasonable risk, EPA is proposing, under TSCA section 6(a), to:

(i) Prohibit the manufacture (including import), processing, and distribution in commerce of TCE for all uses (including all consumer uses (see Unit III.B.1.f)), as described in Unit V.A.1., with longer compliance timeframes for manufacture and processing related to certain uses;

(ii) Prohibit the industrial and commercial use of TCE, as described in Unit V.A.1., with longer compliance timeframes for certain uses;

(iii) Prohibit the manufacture (including import) and processing of TCE as an intermediate for the manufacturing of hydrofluorocarbon134a (HFC-134a), following an 8.5-year phaseout, as described in Unit V.A.1.d.;

(iv) Prohibit the industrial and commercial use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production by Federal agencies and their contractors, following a 10-year phaseout, outlined in Unit V.A.1.e.;

(iv) For Department of Defense (DoD) naval vessels and their systems, and in the maintenance, fabrication, and sustainment for and of such vessels and systems, prohibit the industrial and commercial use of TCE as potting compounds for naval electronic systems and equipment; sealing compounds for high and ultra-high vacuum systems; bonding compounds for materials testing and maintenance of underwater systems and bonding of nonmetallic materials; and cleaning requirements (which includes degreasing using wipes, sprays, solvents and vapor degreasing) for: materials and components required for military ordinance testing; temporary resin repairs in vessel spaces where welding is not authorized; ensuring polyurethane adhesion for electronic systems and equipment repair and installation of elastomeric materials; various naval combat systems, radars, sensors, equipment; fabrication and prototyping processes to remove coolant and other residue from machine parts; machined part fabrications for naval systems; installation of topside rubber tile material aboard vessels; and vapor degreasing required for substrate surface preparation prior to electroplating processes, following a 10-year TSCA section 6(g) exemption, outlined in Unit V.A.3.;

(v) Prohibit the manufacture (including import), processing, distribution in commerce, and use of TCE as a processing aid for battery separator manufacturing, following a 10-year TSCA section 6(g) exemption, as described in Unit V.A.3.;

(vi) Prohibit the manufacture (including import), processing, distribution in commerce, and use of TCE as a laboratory chemical for essential laboratory activities and some research and development activities, following a 50-year TSCA section 6(g) exemption, as described in Unit V. A.3.;

(vii) Prohibit the manufacture (including import), processing, distribution in commerce, and industrial and commercial use of TCE as a solvent in closed loop vapor degreasing necessary for human-rated rocket engine cleaning by the National Aeronautics and Space Administration (NASA) and its contractors, following a 7-year TSCA section 6(g) exemption, as described in Unit V.A.3.;

(viii) Prohibit the emergency industrial and commercial use of TCE in furtherance of the NASA mission for specific conditions that are critical or essential and for which no technically and economically feasible safer alternative is available, following a 10-year TSCA section 6(g) exemption, as described in Unit V.A.3.;

(ix) Require strict workplace controls, including compliance with a TCE workplace chemical protection program (WCPP), which would include requirements for an inhalation exposure limit and dermal protection to limit exposure to TCE, for conditions of use with long term phaseouts or time-

limited exemptions under TSCA section 6(g), as described in Unit V.A.2.;

(x) Prohibit, due to worker risks, the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works, with a 50-year TSCA section 6(g) exemption for cleanup projects, as described in Unit V.A.3.; and

(xi) Establish recordkeeping and downstream notification requirements, as described in Unit V.A.4.

In addition, EPA is proposing to amend the general provisions of 40 CFR part 751, subpart A, to define the following terms 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: “authorized person,” “ECEL,” “exposure group,” “owner or operator,” “potentially exposed person,” “regulated area,” and “retailer.”

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.” TCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in January 2023 (Ref. 2), determining that TCE, 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 TCE no longer presents such risk. The unreasonable risk is described in Unit III.B.2. and the conditions of use EPA evaluated in reaching its conclusion that TCE presents unreasonable risk are described in Unit III.B.1.

TCE's hazards are well established. EPA's 2020 Risk Evaluation for TCE considered the hazards associated with exposure to TCE and determined that TCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to TCE. While some of the risks of adverse effects from TCE exposure are experienced following acute single exposures, other risks are incurred following long-term repeated exposures. Risk of non-cancer effects, specifically fetal cardiac defects and autoimmunity following chronic exposure, are the most sensitive adverse effects. In addition, risks of other significant adverse outcomes associated with TCE exposure include: Non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, immunosuppression, reproductive toxicity, and developmental toxicity), as well as cancer effects (liver, kidney, and non-Hodgkin lymphoma). EPA is proposing requirements so that TCE would no longer present unreasonable risk to human health.

While EPA's proposal would ultimately result in a complete ban on TCE, the Agency recognizes that a phaseout of TCE for some TSCA conditions of use may be appropriate. The timeframes for the phaseouts differ across conditions of use and are described in fuller detail in Unit V.A.1.d. and e. One phaseout is for uses that may impact the Agency's efforts to address climate-damaging HFCs (and the associated adverse impacts on human health and the environment) under the American Innovation and Manufacturing Act of 2020 (AIM Act) (42 U.S.C. 7675). EPA proposes to implement a longer phaseout in tandem with strict workplace controls for the manufacturing (including import) and processing of TCE as an intermediate in the generation of HFC-134a, one of the regulated substances subject to a phasedown under the AIM Act (More information on HFC-134a is in Unit V.A.1.). While HFC-134a is one of the regulated substances subject to AIM Act 85% phasedown in generation and consumption by 2023, HFC-134a can be mixed with other substances to make lower global warming potential (GWP) 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 not have alternatives readily available. As an example, EPA is proposing a longer phaseout timeframe for industrial and commercial use as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production by Federal agencies and their contractors, in addition to the uses of TCE necessary for DoD vessels. Currently, substitutes and alternative processes do not meet the technical specifications required to clean the rayon fabric in order to safely produce rockets.

Additionally, EPA recognizes that some conditions of use may be important for national security applications or for other critical needs. For these reasons, EPA's proposal includes a 10-year exemption under TSCA section 6(g) for industrial and commercial use of TCE as a processing aid for battery separator manufacturing in the production of lead-acid and lithium battery separators, as well as for the manufacturing, processing, and distribution in commerce of TCE for this use (See Unit V.A.3.a.i.). EPA recognizes that lead-acid and lithium battery separators are essential components of batteries that power vehicles and systems in the U.S. supply chain for multiple critical infrastructure sectors within the national economy. Further, there are a number of critical uses required for DoD vessels. EPA is proposing a 10-year exemption under TSCA section 6(g) for DoD vessel requirements for potting, bonding and sealing compounds, and bonding and cleaning requirements for naval combat systems, radars, sensors, equipment, and fabrication and prototyping processes. Additionally, EPA is proposing a 50-year exemption under TSCA section 6(g) for the industrial and commercial use of TCE in laboratory use for essential laboratory activities which are particularly critical; for example, laboratory activities associated with ongoing environmental cleanup projects that fall under the Superfund program or other similar EPA authorities, in which it is necessary to use TCE as a laboratory chemical for the analysis of contaminated soil, air, and water samples (See Unit V.A.3.a.iii.).

EPA considered the potential impact of the prohibition of the total production volume of TCE regulated under TSCA on the availability of TCE for critical or essential uses, for uses essential to the national economy, national security, or critical infrastructure, and for uses for which longer phase-out timeframes are proposed. EPA concluded, based on information received through stakeholder engagement and professional judgment, that there would remain a sufficient supply of TCE in circulation for these uses. EPA requests comment on whether there would remain a sufficient supply of TCE in circulation to provide a source for those limited critical or essential uses exempted under TSCA section 6(g), as described in Unit V. (Ref. 3).

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 VII.D. and XI.D., EPA was unable to quantify all incremental costs of this proposed rule. The quantifiable cost of the proposed rule is estimated to be $33.1 million annualized over 20 years at a 3% discount rate and $40.6 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 0.0011 ppm (1.1 ppb; 0.0059 mg/m

3

) for inhalation exposures as an 8-hour time-weighted average (TWA), applicable personal protective equipment (PPE) requirements, and reformulation costs of numerous products. There are a number of notable unquantified costs. These are described in this Unit and more fully in section 7.11 of the Economic Analysis (Ref. 3).

Alternative products with similar cost and efficacy are available for most of the products that are formulated with TCE. However, for some applications, there may be additional unquantified costs associated with the alternatives or in cases where alternatives are not currently available. For instance, in some cases, some effort might be required by firms using TCE 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. There may also be some safety-critical applications where alternatives would need to undergo extensive safety reviews and testing before they could replace the TCE products. The information to estimate how often these costs might be incurred or what the specific costs would be per-user or per-firm when they are incurred is not available. Therefore, EPA is unable to consider these costs quantitatively.

There also may be some unquantified costs associated with the implementation of a WCPP. EPA estimated a distribution for air monitoring results but since these data were not collected in the same way monitoring data under a WCPP would be collected, these estimated distributions are uncertain and therefore, the costs of the WCPP are uncertain. The WCPP costs also assume that when the exposure levels exceed the ECEL, compliance is achieved by implementing a respirator PPE program. However, the options require that feasible engineering and administrative controls are implemented before resorting to PPE use. These costs would be specific to individual firms, and EPA does not have sufficient information to estimate these costs.

The costs of alternative identification, testing, and potential process changes to battery separator manufacturers could not be estimated. And, if battery separator manufacturers are unable to transition to TCE-free production processes within the 10-year timeframe, there could be battery separator supply chain disruptions. According to one battery separator manufacturer submitting an exemption request to EPA, 80% of lead-acid and lithium-ion batteries are built using battery separators manufactured with TCE. According to the Battery Council International, the U.S. lead-acid battery industry provides $13.7 billion in gross domestic product. Both battery separator manufacturers submitting exemption requests noted that there was only one domestic battery separator manufacturer that does not use TCE for each of lead-acid and lithium batteries, and they asserted that the manufacturers would not have sufficient capacity to meet domestic battery separator demand on their own and could likely support less than half of the U.S. battery production need. In addition, they also noted that the domestic battery separator manufacturer that does not use TCE for lithium batteries uses a “dry process” instead of a “wet process”, and the “dry process” does not allow for reliable manufacture of the 9-12 μm separators that are generally used for electric vehicle applications. However, the magnitude of economic impacts from a potential supply chain disruption is uncertain, particularly since EPA could take subsequent regulatory action to extend, modify, or eliminate the exemption on the basis of reasonably available information and adequate public justification.

EPA expects the processing of TCE as an intermediate for the manufacture of HFC-134a to decline over time, in light of the AIM Act requirements (Ref. 4). At some point, the domestic manufacture of HFC-134a may be discontinued. While the timing for this discontinuation is uncertain, it is unclear whether the proposed rule would hasten the closure of plants that use TCE to produce HFC-134a. There would be some unknown cost impacts associated with hastening the closure of these two plants.

Costs to both fluoroelastomer producers using TCE and those using TCE as an intermediate to manufacture hydrochloric acid (HCl) may include potential supply chain disruptions, which could not be estimated. It is expected that these facilities would need to adopt process and/or physical plant changes in order to comply with the proposed rule. EPA does not have sufficient information to estimate the costs of the prohibition to these sectors.

Additionally, EPA is proposing a 10-year phaseout for the industrial and commercial use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production by Federal agencies and their contractors, conditioned on Federal agencies performing within 5 years a final pre-launch test of rocket booster nozzles that have been produced without using TCE. EPA does not have information to estimate the cost of such a test. The disposal of TCE from cleanup projects to industrial pre-treatment, industrial treatment, or publicly owned treatment work would be prohibited after the section 6(g) exemption ends, 50 years after the rule is finalized. Cleanup sites would need to identify and implement alternative disposal or treatment methods, and would likely also need to renegotiate RCRA permits or CERCLA agreements to include those changes. These approaches could be more costly to implement and/or increase the duration of cleanups allowing any potential environmental or human health impacts to continue for a longer period of time. The information to estimate how often these costs might be incurred or what the specific costs would be per site when they are incurred is not available. Furthermore, the number of sites affected by this prohibition is unknown.

Finally, EPA could not estimate any potential business closures or off-shoring of businesses that might result from the proposed rule. Vapor degreasing is one use of TCE where switching to a suitable alternative may be challenging and where closing or off-shoring may be a compliance strategy. EPA estimates that 366 facilities still use TCE in vapor degreasers, a majority of which are small businesses. There is no standard generally accepted approach for estimating the cost impacts of a firm closure. Despite information EPA has sought from stakeholders, including through a Small Business Advocacy Review (SBAR) Panel, it is still unclear as to the entire impact of a prohibition of TCE vapor degreasing.

The actions proposed in this rulemaking are expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot at present be monetized. The monetized benefits of this rulemaking are approximately $18.1 to $21.5 million annualized over 20

years at a 3% discount rate and $8.2 to $10.3 million annualized over 20 years at a 7% discount rate. The monetized benefits only include liver, kidney, and non-Hodgkin's lymphoma cancers.

There are a number of non-cancer endpoints associated with exposure to TCE, including liver toxicity, kidney toxicity, reproductive effects, neurotoxicity, immunotoxicity effects and fetal cardiac defects (Ref. 1). There is human evidence for hepatitis accompanying immune-related generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, and liver failure in TCE-exposed workers and changes in the proximal tubules of the kidney following exposure to TCE, and occupational studies have shown increased levels of kidney damage (proximal tubules) and end-stage renal disease in TCE-exposed workers. Evidence exists to associate TCE with reproductive effects. Most human studies support an association between TCE exposure and alterations in sperm density and quality, as well as changes in sexual drive or function and serum endocrine levels. Fewer epidemiological studies exist linking decreased incidence of fecundability (time-to-pregnancy) and menstrual cycle disturbances in women with TCE exposures. Human studies have consistently reported vestibular system-related symptoms such as headaches, dizziness, and nausea following TCE exposure. Several newer epidemiological studies have found an association between TCE exposure and neurodegenerative disorders such as amyotrophic lateral sclerosis and Parkinson's disease (Ref. 1). EPA does not have sufficient information to estimate the monetized benefits of the proposed rule with respect to these non-cancer effects, and therefore monetized benefits are likely underestimated.

EPA does estimate that there are 52,595 workers and occupational non-users (ONUs, or people who do not directly handle the chemical, but are in close proximity) exposed to TCE and of those, approximately 982 pregnant workers and ONUs annually that may potentially benefit from a reduced risk of fetal cardiac defects resulting from reduced TCE exposure. Although EPA has not developed a complete estimate of the monetized benefits associated with avoiding fetal cardiac defects, as described in the Economic Analysis (Ref. 3), Arth, Tinker et al. (Ref. 5) estimated a mean annual cost of $41,166 (2013$) (median $14,552) for each fetal cardiac defects-associated hospitalization. For critical fetal cardiac defects, mean and median costs were estimated at $79,011 and $29,886 (2013$), respectively for each incidence. In addition to hospitalization costs, individuals with fetal cardiac defects will likely incur healthcare costs associated with physician visits and outpatient care. They are also more likely to require specialized healthcare such as medications, physical or speech therapy, or treatment for developmental or behavioral problems (Ref. 6). Additional social costs may include caregiver burden and mental health services (Ref. 7), as well as non-market costs such as pain and suffering and fetal cardiac defect-related mortality. Because these costs are not accounted for, monetized benefits are likely underestimated. The severity of specific types of fetal cardiac defects and associated costs will vary depending on the type of heart defect. EPA requests comment on information that would allow EPA to quantify the magnitude of avoided risk of fetal cardiac defects due to reductions in TCE exposure under the proposed rulemaking.

Additionally, to the extent that the proposed rule reduces the amount of TCE in drinking water systems and thereby exposures to populations using those drinking water sources, there could be potential health-related benefits related to improved drinking water quality that EPA was unable to quantify.

II. Background

A. Overview of TCE

This proposed rule applies to TCE (CASRN 79-01-6) and is intended to address the unreasonable risk of injury to health that EPA has identified for TCE. TCE is a volatile organic compound (VOC) used in industry as well as in commercial and consumer products. The total aggregate annual production volume ranged from 100 to 250 million pounds between 2016 and 2019 according to CDR (Ref. 8). The majority of TCE is processed as an intermediate during the manufacture of refrigerants, specifically HFC-134a, which accounts for about 83.6% of TCE's annual production volume (Ref. 1). TCE is also used as a solvent, frequently in cleaning and degreasing (including spot cleaning, vapor degreasing, cold cleaning, and aerosol degreasing), which accounts for another 14.7% of TCE production volume, leaving approximately 1.7% for other uses. As outlined in Unit III.B.1., TCE is used as a solvent in a variety of commercial and consumer applications including lubricants, adhesives and sealants, paints and coatings, and other miscellaneous products.

B. Regulatory Actions Pertaining to TCE

TCE 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 TCE, as well as other Federal, State, and international regulations (Ref. 9) is in the docket and in Appendix A of the 2020 Risk Evaluation for TCE (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 non-risk 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.” 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 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 unit 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. 9) 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, 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. 10). 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 TCE. 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 document, 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 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 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 (derived from scientific

studies that had not yet been conducted at the time OSHA promulgated its standards) 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 OSHA's chemical-specific standards are decades old and may include outdated assumptions regarding the most sensitive end-point and/or the technological and economic feasibility of the standards, 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. Unit II.C.2. 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.). However, the Agency acknowledges that, in some cases, mitigation measures are already in place. It should be noted that there are some cases where scenarios may reflect certain mitigation measures, such as (

e.g.,

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 EPA does not question the veracity of public comments received on the 2020 Risk Evaluation for TCE 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 (

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 compatibility with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls, 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. 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 (see Unit III.B.1.f.), 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. TCE and OSHA Requirements

EPA incorporated the considerations described in Unit II.C. into the 2020 Risk Evaluation for TCE, the January 2023 revised unreasonable risk determination for TCE, and this rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for TCE, 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 drove the unreasonable risk. Additional consideration of OSHA standards in the revised unreasonable risk determination is discussed further in the

Federal Register

document announcing that document (Ref. 11). In Unit III.B.3. and Unit V.A.2.b.iii., EPA outlines the importance of considering the hierarchy of controls used 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 TCE. The hierarchy of controls is a prioritization of exposure control strategies from most preferred to least preferred techniques. The control strategies include 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. 12). Under the hierarchy of controls, the use of respirators and dermal PPE should only be considered after all other steps have been taken to reduce exposures. As discussed in Units V.A. and VI.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 all conditions of use, with a WCPP for certain occupational conditions of use before the prohibitions are fully implemented. 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 V.A.2. and VI.A.1.b.

In accordance with the approach described in Unit II.C.3., EPA intends for this regulation to be as compatible 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 either 0.0011 ppm (1.1 ppb) or 0.0040 ppm (4.0 ppb) as an 8-hour TWA; exposures at or below each ECEL would not result in unreasonable risk for chronic cancer and non-cancer and acute non-cancer inhalation endpoints (See Unit IV.A. for further discussion about an ECEL of 0.0011 ppm and Unit IV.B. for further discussion about an ECEL of 0.0040 ppm. Refer to Unit VI.A. for discussion about why EPA is considering two TCE ECELs and EPA's related request for public comment). EPA recognizes that for TCE, either 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 TCE is a lower value than the OSHA PEL (and other existing OELs, discussed in Unit II.C.5.) for many reasons, including that the PEL, established in 1971, may not fully capture either the complete database of studies considered in the 2020 Risk Evaluation for TCE or more recent advances in modeling and scientific interpretation of toxicological data applied in the calculation of the TCE ECEL. The proposed numeric ECEL values considered for incorporation into the WCPP are derived from the analysis in the 2020 Risk Evaluation for TCE, which EPA considers to represent the best available science under TSCA section 26(h) because it was subject to peer review and is the result of a systematic review process that considered reasonably available information in order to identify relevant adverse health effects. Additionally, by using the information from the 2020 Risk Evaluation for TCE, the ECEL incorporates advanced modeling and peer-reviewed methodologies, and accounts for exposures to potentially exposed and susceptible subpopulations, as required by TSCA.

For TCE, the EPA ECEL is an 8-hour occupational inhalation exposure limit, and it takes into consideration the uncertainties identified in the 2020 Risk Evaluation for TCE. For TCE, EPA derived two distinct ECEL values.

The ECEL of 0.0011 ppm is based on the most sensitive overall human health endpoint of developmental toxicity, specifically, fetal cardiac defects based on rat data from Johnson et al., 2003 (Refs. 1, 13). It represents the concentration at which an individual, including a member of a PESS, especially older pregnant workers and ONUs (the group identified as most susceptible to cardiac defects in their developing fetus based on epidemiological data), would be unlikely to suffer adverse effects if exposed for a single 8-hr workday. This value is also protective of health effects that could present following chronic or lifetime exposures under typical occupational exposure scenarios. The ECEL of 0.0011 ppm incorporates a benchmark margin of exposure of 10 to account for inter- and intra-species toxicodynamic variability. In addition to the ECEL, as part of this rulemaking, EPA is proposing an ECEL action level, which is a value equal to half of the ECEL, that would trigger additional monitoring to ensure that workers are not exposed to concentrations above the ECEL. Exposure monitoring and establishing a baseline of TCE exposure for potentially exposed persons, as well as identifying the lowest achievable exposure level in a facility, is further discussed in Unit V.A.2.

The ECEL of 0.0040 ppm is based on chronic autoimmunity, representing the most protective exposure limit from the best overall acute and chronic non-cancer endpoints under TSCA of immunosuppression and autoimmunity, respectively (Refs. 14, 46, 1). The ECEL of 0.0040 ppm is based on elevated anti-double stranded DNA (anti-dsDNA) and single-stranded DNA (ssDNA) antibodies following chronic exposure based on mouse data from Keil et al, 2009 (Ref. 1). The ECEL based on autoimmunity was derived from the PBPK model-adjusted assumptions of 8-

hour daily exposure and elevated respiratory rate for workers, and it incorporates a benchmark MOE of 30 to account for inter- and intra-species toxicodynamic variability as well as the absence of a no-effect level in the study (Ref. 1).

The OSHA PEL for TCE 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) at the time of promulgation. As part of a 1989 air contaminants standard for 428 toxic substances, OSHA lowered the PEL to 50 ppm based on a quantitative cancer risk assessment and technological feasibility analysis (See 54 FR 2332, 2432(1989)). This rulemaking was later vacated by court order, which held that OSHA failed to establish that: (1) the existing PELs presented a significant risk of material health impairment; (2) the new standards eliminated or substantially lessened the risk; and (3) the new PELs were economically or technologically feasible (Ref. 15). As a result, the PEL for TCE reverted to the original PEL of 100 ppm. The basis of the 100 ppm PEL is unclear; however, most original PELs were based on acute health effects only observable at higher concentrations and did not take into account more sensitive repeated dose studies, including the studies used to inform the TCE ECEL, that 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 VIII.D., the TSCA ECELs for the TCE WCPP are based on the 2020 Risk Evaluation for TCE and represent the best available science. As described in Unit II.C.1., in a 2014 request for information OSHA described how, while new developments in science and technology from the time the PEL for TCE 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 TCE and it remains at the level that was originally adopted in 1971 (79 FR 61383, October 10, 2014).

5. TCE and Other Occupational Exposure Limits

EPA is aware of other OELs for TCE, 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 currently recommended by the ACGIH is 10 ppm, based on a most recent update in 2007. This TLV is based on central nervous system (CNS) effects occurring at 100 ppm and above (Ref. 16). Kidney toxicity, cancer, and developmental toxicity were also indicated at high doses. Overall, the 10 ppm TLV does not seem to be directly derived from any particular endpoint and can be considered only a semi-quantitative estimate. The TLV report did not cite either the immune study used as the basis of EPA's alternative ECEL of 0.0040 ppm (Keil et al., 2009), nor did it cite Johnson et al., 2003, which is the basis of EPA's proposed ECEL of 0.0011 ppm. Notably, the most recent TLV report was released prior to publication of Keil et al., 2009, and the TLV was not directly derived from any particular endpoint or hazard value. Among other cited studies that are discussed in the 2020 Risk Evaluation, the TLV report only discusses LOAELs and did not apply benchmark dose modeling, PBPK modeling, or any uncertainty factors that would have contributed to a reduced exposure limit. The report does identify TCE as a suspected human carcinogen and discusses epidemiological evidence for several cancers, but there is no consideration of low-dose linear extrapolation that would have resulted in a substantially lower TLV.

The current NIOSH REL is based on the “lowest feasible level” standard applied to carcinogens, labeled as “Ca (potential occupational carcinogen), minimize exposure concentrations” (Ref. 17), as well as a 2 ppm 60-minute ceiling REL value when used as an anesthetic agent and a 25 ppm 10-hour TWA REL for other exposures. As described in NIOSH's Appendix A, the non-quantitative value applied to carcinogens is based on the lowest feasible concentration (Ref. 18). The 25 ppm TWA was based on concerns for CNS effects at higher doses and a review of industrial hygiene reports supporting the feasibility of a 25-ppm limit. Notably, this ceiling limit is from 1990, over a decade before publication of any of the key studies EPA used for risk determination or ECEL derivation.

The 2007 Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and equivalent to the NIOSH REL TWA (Ref. 19). According to Cal/OSHA, the origin of the Cal/OSHA PEL is not clear but is assumed to be based on the NIOSH REL threshold value, which cited CNS effects and liver cancer in animals (Ref. 20).

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

In December 2016, EPA selected TCE as one of the first 10 chemicals for risk evaluation under TSCA section 6 (15 U.S.C. 2605) (81 FR 91927, December 19, 2016) (FRL-9956-47). EPA published the scope of the TCE risk evaluation (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 February 2020, EPA published a draft risk evaluation (85 FR 11079, February 26, 2020) (FRL-10005-52), and after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk Evaluation for TCE in November 2020 in accordance with TSCA section 6(b) (85 FR 75010, November 24, 2020) (FRL-10016-91). EPA subsequently issued a draft revised TSCA unreasonable risk determination for TCE (87 FR 40520, July 7, 2022) (FRL-9945-01-OCSPP) and after public notice and receipt of comments, published a final revised Unreasonable Risk Determination for TCE in January 2023 (88 FR 1222, January 9, 2023) (FRL-9945-02-OCSPP). The 2020 Risk Evaluation for TCE and supplemental materials are in docket EPA-HQ-OPPT-2019-0500, with the January 2023 final revised unreasonable risk determination and additional materials supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0737, on

https://www.regulations.gov.

1. 2020 Risk Evaluation

In the 2020 Risk Evaluation for TCE, EPA evaluated risks associated with 54 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal (Ref. 1). Descriptions of these conditions of use are in Unit III.B.1.

The 2020 Risk Evaluation for TCE identified significant adverse health effects associated with short- and long-term exposure to TCE, including non-cancer effects (immunosuppression and developmental toxicity) from acute inhalation exposures and dermal exposures, and non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity, reproductive toxicity, and developmental toxicity) and cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic inhalation exposures to TCE. A further discussion of the hazards of TCE is in Unit III.B.2.

In the 2020 Risk Evaluation for TCE, EPA documented its unreasonable risk

policy determination for TCE and based it on the immunotoxicity endpoint rather than the most sensitive endpoint (developmental toxicity). The 2020 Risk Evaluation for TCE included a robust scientific description of the developmental toxicity endpoint, specifically fetal cardiac defects, and the analysis in the risk evaluation supporting the developmental toxicity endpoint noted that this endpoint presents lower PODs (Ref. 1). EPA identified the risk of fetal cardiac defects most strongly associated with offspring of older mothers, and therefore included risk estimates for fetal cardiac defects that account for susceptible mothers and their offspring in addition to PESS groups with other susceptibilities (

e.g.,

diabetes, infection status, drug exposure, stress, and metabolic sensitivity due to increased enzymatic activity of cytochrome P450 2E1 (CYP2E1)) (Ref. 1). EPA recognizes that there are differing views about the appropriateness of EPA's policy decision in 2020 to use the immunotoxicity endpoint as the basis for EPA's unreasonable risk determination. EPA also notes that the endpoint selected as the basis for the TSCA section 6 unreasonable risk determination in the risk evaluation that is the basis for this proposed rule should not necessarily be construed as appropriate for or consistent with the basis for other Agency assessments such as the Integrated Risk Information System (IRIS) assessment for TCE or for actions taken by other agency programs. Further, EPA has received numerous comments on EPA's 2020 TSCA Risk Evaluation policy choice regarding endpoint selection that have raised concerns pertaining to political interference and scientific integrity, among other issues. In recognition of this history, EPA is therefore requesting comment on the use of the more sensitive developmental toxicity endpoint to inform TCE risk management decisions. In particular, EPA notes that this proposed rule for regulating the unreasonable risk of TCE demonstrates that both the immunotoxicity and developmental toxicity endpoints support the proposed prohibitions, discussed in detail in Unit IV.

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 TCE, 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 TCE, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for TCE and issued a final revised unreasonable risk determination in January 2023 (Ref. 2). EPA revised the risk determination for the 2020 Risk Evaluation for TCE pursuant to TSCA section 6(b) and Executive Order 13990, (entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 21, 22, 23). The revisions consisted of making the risk determination for the whole chemical substance rather than for 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 TCE 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 irreversibility of the hazard); and uncertainties.

EPA determined that TCE presents an unreasonable risk of injury to health. The unreasonable risk determination, based on immunotoxicity and cancer, 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 TCE (

i.e.,

during manufacture, processing, industrial and commercial uses, and disposal); and to consumers and bystanders associated with consumer uses of TCE due to exposures from consumer use of TCE and TCE-containing products. Though the revised unreasonable risk determination was based on cancer and the best overall non-cancer endpoints for use in risk evaluation under TSCA (immunosuppression effects for acute inhalation and dermal exposures, and autoimmunity effects for chronic inhalation and dermal exposures), consistent with the 2020 Risk Evaluation for TCE, the Agency is proposing to base the risk management requirements for the WCPP on a more sensitive endpoint to account for particular health effects identified in the underlying 2020 Risk Evaluation for TCE relevant to PESS, as discussed in Unit IV.A. and V.A.2.

EPA did not identify unreasonable risk of injury to the environment for TCE. The TCE conditions of use that EPA evaluated and whose risk support 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.

3. Fenceline Screening Analysis

The 2020 Risk Evaluation for TCE 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 November 2020 Risk Evaluation for TCE (Ref. 1). This resulted in the surface water, drinking water, and ambient air pathways for TCE 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 could lead to a failure to adequately protect fenceline communities (Ref. 24). EPA then conducted a screening analysis to identify whether there may be risks to people living near the fenceline of facilities releasing TCE.

In order to assess whether there are no risks of concern or whether there may be risks of concern to the general population in proximity to a facility releasing TCE, 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. 25). This screening level approach, which EPA believes is very effective in accurately assessing where fenceline exposures are of no concern is discussed in Unit VII.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, so that TCE no longer presents such unreasonable risk. EPA's proposed regulatory action and a primary alternative regulatory action are described in Unit V. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory action 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 timeframes 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 the need for an exemption and has found that TSCA section 6(g) exemptions are warranted for certain conditions of use, as detailed in Unit V.A.3. 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 and the primary alternative regulatory action, 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 VI.B. 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 VI.B. includes more information regarding EPA's consideration of alternatives, and Units IV. and VII. provide 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, 2021, 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. 26). During the consultation, participants and EPA discussed preemption; the authority given under TSCA section 6 to regulate identified unreasonable risk; which activities would be potentially regulated in the proposed rule; TSCA reporting requirements; key local constituencies; and the relationship between TSCA and existing statutes, particularly the Clean Water Act (CWA) and the Safe Drinking Water Act (SDWA) (Ref. 26).

TCE 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. 27). 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, participants and EPA discussed concerns from Tribal members about the TCE OSHA exposure limit being outdated, Tribal interest in seeing TCE

banned, and concerns that third party disposal may be occurring near Tribal lands, with a particular interest in protecting workers at publicly owned treatment works (Ref. 27). 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 TCE, such as communities with environmental justice concerns. EPA's Environmental Justice (EJ) consultation occurred from June 3, 2021, through August 20, 2021. On June 16 and July 6, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to Executive Orders 12898 and 14008. EPA received three written comments following the EJ meetings, in addition to oral comments provided during the consultation (Refs. 28, 29, 30). In general, commenters supported strong regulation of TCE to protect lower-income communities and workers, strong outreach to affected communities, encouraged EPA to follow the National Institute for Occupational Safety and Health (NIOSH) hierarchy of controls, favored prohibitions, and noted the uncertainty, and, in some cases, inadequacy, of personal protective equipment (Ref. 31).

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. 32). EPA met with SERs before and during Panel proceedings, on October 28, 2022, and January 31, 2023. Panel recommendations are in Unit XI.C. and in the Initial Regulatory Flexibility Analysis (Ref. 33), the Panel report is in the docket (Ref. 32).

Units XI.C., XI.E., XI.F., and XI.J. provide more information regarding the consultations.

2. Other Stakeholder Engagement

In addition to the formal consultations described in Unit XI., EPA held a webinar on December 15, 2020, providing an overview of the TSCA risk management process and the risk evaluation findings for TCE. EPA also presented on the risk evaluation and risk management under TSCA for TCE at a Small Business Administration small business roundtable on December 18, 2020. At both events EPA staff provided an overview of the TSCA risk management process and the findings in the 2020 Risk Evaluation for TCE (Ref. 34). Attendees of these meetings were given an opportunity to voice their concerns 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 TCE. A list of external meetings held during the development of this proposed rule is in the docket (Ref. 35); 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 TCE; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to TCE under the conditions of use; understand the importance of TCE 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 public interest 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. 35).

3. Children's Environmental Health

The EPA 2021 Policy on Children's Health (Ref. 36) 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 based on lifestage 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 TCE no longer presents an unreasonable risk (including unreasonable risk to PESS). Furthermore, TSCA 6(c)(2)(B) requires EPA to “factor in, to the extent practicable,” the considerations under TSCA section 6(c)(2)(A) when selecting among prohibitions and other restrictions in TSCA section 6(a) rules, including taking into consideration the magnitude of exposure to human health, as further discussed in Unit IV.

The 2020 Risk Evaluation for TCE evaluated the hazards of TCE to all lifestages. Evidence of developmental hazards were observed for increased resorptions, fetal cardiac defects and decreased rearing activity (

i.e.,

neurotoxicity). These effects occur in the offspring exposed either

in utero

or postnatally, with older pregnant women identified as especially susceptible to cardiac defects in their developing fetus based on epidemiological data. Adverse health effects to reproduction following TCE exposure include decreased normal sperm morphology and hyperzoospermia along with delayed onset of birth. The most sensitive non-cancer hazard identified for non-reproductive or developmental effects is autoimmunity following chronic exposure to TCE.

The 2020 Risk Evaluation for TCE considered impacts on both children and adults from occupational and consumer use from inhalation and dermal exposures, as applicable. The 2020 Risk Evaluation for TCE identified consumers and bystanders associated with use of TCE-containing consumer products as potentially exposed and susceptible subpopulations due to greater exposure. Consumer users are considered to include adults as well as children as young as 11. Bystanders in the home exposed via inhalation are considered to include any age group from infant (including breast-fed infants) to adult (including elderly), including pregnant women and individuals of reproductive age. Younger lifestages are likely exposed to higher internal dose concentrations of TCE than adults due to relative physiological differences in body weight, breathing rate, and other parameters. A further discussion on the magnitude of health effects and EPA's consideration of these health effects in this proposed rule is in Unit IV.

B. Regulatory Assessment of TCE

1. Description of Conditions of Use

This unit describes the TSCA conditions of use whose risk EPA evaluated and considered in making its unreasonable risk determination for the chemical substance TCE. Condition of use descriptions were obtained from EPA sources such as CDR use codes, the 2020 Risk Evaluation for TCE 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 TCE, the 2020 Risk Evaluation for TCE, and supplemental files (Refs. 37, 1, 38). EPA acknowledges that some of the terms used in this unit may also be defined under other statutes; however, the descriptions here are intended to provide clarity to the regulated entities who would be subject to the provisions of this proposed rule under TSCA section 6(a).

a. Manufacturing

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 TCE 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. 39).

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 TCE in chemical reactions for the manufacturing of another chemical substance or product, notably including but not limited to 1,1,1,2-tetrafluoroethane, an HFC also known as HFC-134a, which is used as a refrigerant and in fluorocarbon blends for refrigerants. This condition of use includes reuse of byproduct or residual TCE as a reactant.

ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction Product

This condition of use refers to when TCE is added to a product (or product mixture) prior to further distribution of the product; such products include but are not limited to solvents (for cleaning or degreasing), adhesives and sealant chemicals, and solvents that become part of a product formulation or mixture (

e.g.,

lubricants and greases, paints and coatings, other uses).

iii. Processing: Incorporation Into Articles

This condition of use refers to when a chemical substance becomes an integral component of an article distributed for industrial, commercial, or consumer use.

iv. Processing: Repackaging

This condition of use refers to the preparation of a chemical substance for distribution in commerce in a different form, state, or quantity. This includes but is not limited to transferring the chemical from a bulk container into smaller containers.

v. Processing: Recycling

This condition of use refers to the process of managing used solvents that are collected, either on-site or transported to a third-party site, for commercial purpose other than disposal. Spent 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 process of heating TCE to its volatilization point and using its vapor to remove dirt, oils, greases, and other surface contaminants (such as drawing compounds, cutting fluids, coolants, solder flux, and lubricants) from metal parts, electronics, or other articles in batch open-top vapor degreasers (OTVDs).

ii. Industrial and Commercial Use as Solvent for Closed-Loop Batch Vapor Degreasing

This condition of use refers to the process of heating TCE to its volatilization point and using its vapor to remove dirt, oils, greases, and other surface contaminants (such as drawing compounds, cutting fluids, coolants, solder flux, and lubricants) from metal parts, electronics, or other articles in batch closed-loop vapor degreasers.

iii. Industrial and Commercial Use as Solvent for In-Line Conveyorized Vapor Degreasing

This condition of use refers to the process of heating TCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from textiles, glassware, metal surfaces, and other articles using in-line conveyorized degreasing machines.

iv. Industrial and Commercial Use as Solvent for In-Line Web Cleaner Vapor Degreasing

This condition of use refers to the process of heating TCE to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from textiles, glassware, metal surfaces, and other articles using in-line web cleaning degreasing machines.

v. Industrial and Commercial Use as Solvent for Cold Cleaning

This condition of use refers to the industrial and commercial use of TCE as a non-boiling solvent in cold cleaning to dissolve oils, greases and other surface contaminants from textiles, glassware, metal surfaces, and other articles.

vi. Industrial and Commercial Use as a Solvent for Aerosol Spray Degreaser/Cleaner and Mold Release

This condition of use refers to industrial and commercial use of TCE in aerosol degreasing as an aerosolized solvent spray, typically applied from a pressurized can, to remove residual contaminants from fabricated parts or machinery (including circuit boards and electronics). This description also applies to the use of TCE in products to remove dirt, grease, stains, spots, and foreign matter, including but not limited to release agent residues, from molds and casting surfaces.

vii. Industrial and Commercial Use as a Lubricant and Grease in Tap and Die Fluid

This condition of use refers to industrial and commercial use of TCE in products such as, but not limited to, metalworking, cutting, and tapping fluid to reduce friction, heat generation and wear, to assist in metal shaping, and to protect the part being shaped from oxidation. This description does not apply to use of TCE in products intended as penetrating lubricant, which are described in a different condition of use.

viii. Industrial and Commercial Use as a Lubricant and Grease in Penetrating Lubricant

This condition of use refers to the industrial and commercial use of TCE in products as a lubricant and grease in penetrating lubricant, to reduce friction, heat generation and wear between surfaces. This description does not apply to use of TCE in products intended as metalworking, cutting and tapping fluids, which are described in a different condition of use.

ix. Industrial and Commercial Use as an Adhesive and Sealant in Solvent-Based Adhesives and Sealants; Tire Repair Cement/Sealer; Mirror Edge Sealant

This condition of use refers to industrial and commercial use of TCE 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 as a Functional Fluid in Heat Exchange Fluid

This condition of use refers to the industrial and commercial use of TCE as a functional fluid in heat exchange fluid used to transmit or to remove heat from another material in a closed system.

xi. Industrial and Commercial Use in Paints and Coatings as a Diluent in Solvent-Based Paints and Coating

This condition of use refers to industrial and commercial use of TCE in paints and coatings that are applied to surfaces to enhance properties such as, but not limited to, water repellency, gloss, fade resistance, ease of application, or foam prevention.

xii. Industrial and Commercial Use in Cleaning and Furniture Care Products in Carpet Cleaner and Wipe Cleaning

This condition of use refers to the industrial and commercial use of TCE in products to remove dirt, grease, stains, spots, and foreign matter from furniture and furnishings, including but not limited to carpets and rugs. This description also applies to use of TCE in 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. This description does not apply to the use of TCE as a spot remover for laundry and dishwashing, which is described in a different condition of use.

xiii. Industrial and Commercial Use in Laundry and Dishwashing Products in Spot Remover

This condition of use refers to industrial and commercial use of TCE as a solvent in products for cleaning in laundry and dishwashing applications to remove dirt, grease, stains, spots, and foreign matter from garments and dishware.

xiv. Industrial and Commercial Use in Arts, Crafts, and Hobby Materials in Fixatives and Finishing Spray Coatings

This condition of use refers to the industrial and commercial use of TCE in aerosol products, such as, but not limited to, fixatives, shellacs, or other spray applied coatings intended to cover or hold other arts and crafts materials to a surface.

xv. Industrial and Commercial Use in Corrosion Inhibitors and Anti-Scaling Agents

This condition of use refers to the industrial and commercial use of TCE in corrosion inhibitors and anti-scaling agents as a chemical substance used to prevent or retard corrosion or the formation of scale. As a corrosion inhibitor, TCE is used to prevent or retard corrosion on metallic materials. As an anti-scaling agent, TCE is added to products to prevent the build-up of inorganic oxide deposits.

xvi. Industrial and Commercial Use in Processing Aids in Process Solvent Used in Battery Manufacture; Process Solvent Used in Polymer Fabric Spinning, Fluoroelastomer Manufacture and Alcantara Manufacture; Extraction Solvent Used in Caprolactam Manufacture; Precipitant Used in Beta-Cyclodextrin Manufacture

This condition of use refers to industrial and commercial use of TCE as a processing aid. A process solvent is a chemical substance used to improve the processing characteristics or the operation of process equipment when added to a process or to a substance or mixture to be processed. The chemical substance is not intended to become a part of the reaction product nor has function in the reaction product.

xvii. Industrial and Commercial Use as Ink, Toner, and Colorant Products in Toner Aid

This condition of use refers to the industrial and commercial use of TCE in ink, toner, and colorant products in toner aid as chemical substance used for writing, printing, creating an image on paper and other substrates, or applied to substrates to change their color or hide images. This includes but is not limited to pigmented liquids, toners or powders contained in cartridges, bottles, or other dispensers used in printers and copy machines. This category includes printing inks for commercial applications.

xviii. Industrial and Commercial Use in Automotive Care Products in Brake and Parts Cleaner

This condition of use refers to the industrial and commercial use of TCE in products to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces. This description includes but is not limited to use of products for motorized vehicle maintenance and their parts.

xix. Industrial and Commercial Use in Apparel and Footwear Care Products in Shoe Polish

This condition of use refers to the industrial or commercial use of TCE in apparel and footwear care products as post-market waxes, polishes, or other mediums and applied to footwear, textiles, or fabrics to impart color or other desirable properties.

xx. Industrial and Commercial Use in Hoof Polish, Gun Scrubber, Pepper Spray, Other Miscellaneous Industrial and Commercial Uses

This condition of use refers to the industrial and commercial use of TCE in which it is expected to act similar to a cleaning solvent used to remove dirt or other contaminants from substrates. This description also refers to other miscellaneous products which contain TCE as an additive to impart or enhance desirable properties of another material (

e.g.,

adhesive, sealant, propellant). Additionally, this condition of use refers to the industrial and commercial use of TCE, often in small quantities, in a laboratory for chemical analysis (

e.g.,

to test hot mix asphalt binder content, as a reference standard, etc.), chemical synthesis, extracting and purifying other chemicals, dissolving other substances, and similar activities.

d. Consumer Use

i. Consumer Use as a Solvent in Brake and Parts Cleaner

This condition of use refers to the consumer use of TCE in products to remove dirt, grease, stains, and foreign matter from interior and exterior vehicle surfaces, particularly in brake cleaner and parts cleaner.

ii. Consumer Use as a Solvent in Aerosol Electronic Degreaser/Cleaner

This condition of use refers to the consumer use of TCE as a solvent in degreasing and cleaning products used

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.

iii. Consumer Use as a Solvent in Liquid Electronic Degreaser/Cleaner

This condition of use refers to the consumer use of TCE as a solvent in degreasing and cleaning products used to remove dirt, grease, stains, spots, and foreign matter through a process that uses a liquid solvent to remove residual contaminants from electronics.

iv. Consumer Use as a Solvent in Aerosol Spray Degreaser/Cleaner

This condition of use refers to the consumer use of TCE as a solvent in degreasing and cleaning products used 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 metals and other fabricated materials not described elsewhere in this unit.

v. Consumer Use as a Solvent in Liquid Degreaser/Cleaner

This condition of use refers to the consumer use of TCE as a solvent in liquid degreasing and cleaning products used to remove dirt, grease, stains, spots, and foreign matter from metals and other fabricated materials not described elsewhere.

vi. Consumer Use as a Solvent in Aerosol Gun Scrubber

This condition of use refers to the consumer use of TCE as a solvent in aerosol products in which it is expected to act similar to a cleaning solvent used to remove residue, dirt, grease, or other contaminants, in particular but not limited to gun scrubber.

vii. Consumer Use as a Solvent in Liquid Gun Scrubber

This condition of use refers to the consumer use of TCE as a solvent in liquid products in which it is expected to act similar to a cleaning solvent used to remove residue, dirt, grease, or other contaminant, in particular but not limited to gun scrubber.

viii. Consumer Use as a Solvent in Mold Release

This condition of use refers to the consumer use of TCE in mold release 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.

ix. Consumer Use as a Solvent in Aerosol Tire Cleaner

This condition of use refers to the consumer use of TCE as an additive in aerosol products to impart or enhance desirable properties of another material, particularly in use as tire cleaner.

x. Consumer Use as a Solvent in Liquid Tire Cleaner

This condition of use refers to the consumer use of TCE as an additive in liquid products to impart or enhance desirable properties of another material, particularly in use as tire cleaner.

xi. Consumer Use as a Lubricant and Grease in Tap and Die Fluid

This condition of use refers to the consumer use of TCE in products to reduce friction, heat generation and wear between solid surfaces, particularly in tap and die fluid.

xii. Consumer Use as a Lubricant and Grease in Penetrating Lubricant

This condition of use refers to the consumer use of TCE in products to reduce friction, heat generation and wear between solid surfaces, particularly in penetrating lubricant.

xiii. Consumer Use as an Adhesive and Sealant in Solvent-Based Adhesive and Sealants

This condition of use refers to the consumer use of TCE as a solvent in single or two component products used to fasten other materials together or prevent the passage of liquid or gas. This description does not apply to products for mirror edge sealant or tire repair, which are described in different conditions of use.

xiv. Consumer Use as an Adhesive and Sealant in Mirror Edge Sealant

This condition of use refers to the consumer use of TCE in single or two component products used to fasten other materials together or prevent the passage of liquid or gas, particularly in mirror edge sealant.

xv. Consumer Use as an Adhesive and Sealant in Tire Repair Cement/Sealer

This condition of use refers to the consumer use of TCE in single or two component products used to fasten other materials together or prevent the passage of liquid or gas, particularly in cement or sealant for tire repair.

xvi. Consumer Use as a Cleaning and Furniture Care Product in Carpet Cleaner

This condition of use refers to the consumer use of TCE as a solvent in cleaning and furniture care products used to remove dirt, grease, stains, spots, foreign matter, and residual contaminants, particularly in carpet cleaner.

xvii. Consumer Use as a Cleaning and Furniture Care Product in Aerosol Spot Remover

This condition of use refers to the consumer use of TCE as a solvent in cleaning and furniture care products used 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, particularly in aerosol spot remover.

xviii. Consumer Use as a Cleaning and Furniture Care Product in Liquid Spot Remover

This condition of use refers to the consumer use of TCE as a solvent in cleaning and furniture care products in the form of a solid or liquid cleaner, used to remove dirt, grease, stains, spots, foreign matter, and residual contaminants, particularly in liquid spot remover.

xix. Consumer Use in Arts, Crafts, and Hobby Materials in Fixative and Finishing Spray Coatings

This condition of use refers to the consumer use of TCE in arts, crafts, and hobby products that uses an aerosolized solvent spray, typically applied from a pressurized can, intended to cover or hold other arts and crafts materials to a surface, particularly in fixative and finishing spray coatings.

xx. Consumer Use in Apparel and Footwear Products in Shoe Polish

This condition of use refers to the consumer use of TCE in apparel and footwear care products as post-market waxes, polishes, or other mediums and applied to footwear, textiles, or fabrics to impart color or other desirable properties.

xxi. Consumer Use in Fabric Spray

This condition of use refers to the consumer use of TCE in aerosol products, typically applied from a pressurized can, as an additive to enhance desirable properties of another material, particularly in fabric spray and as an anti-fray spray.

xxii. Consumer Use in Film Cleaner

This condition of use refers to the consumer use of TCE in products as an additive to impart or enhance the desirable properties of another material, particularly in film cleaner.

xxiii. Consumer Use in Hoof Polish

This condition of use refers to the consumer use of TCE as an additive to impart or enhance desirable properties of another material, particularly in hoof polish.

xxiv. Consumer Use in Toner Aid

This condition of use refers to the consumer use of TCE in products as an additive to impart or enhance the desirable properties of another material, particularly in toner aid.

e. Disposal

This condition of use refers to the process of disposing of generated waste streams of TCE that are collected either on-site or transported to a third-party site. This includes the mixing of TCE with wastewater and the discharge of TCE-contaminated wastewater pursuant to a NPDES permit, and specifically includes discharge to industrial pre-treatment, industrial treatment, or publicly owned treatment works. While EPA views the disposal condition of use under TSCA broadly (see,

e.g.,

EPA's proposed regulation on certain conditions of use of chrysotile asbestos (Ref. 40), for the purpose of this rulemaking under TSCA section 6(a), based on the underlying analysis in the 2020 TCE risk evaluation, EPA's proposed regulations specifically address the risk to PESS from disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works. EPA recognizes that this includes activities that may not be considered disposal under other statutes, such as RCRA and the CWA.

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 TCE for purposes of distinguishing scenarios, the Agency clarified then and clarifies now that EPA interprets the authority over “any manner or method of commercial use” under TSCA section 6(a)(5) to reach both.

Additionally, in the 2020 Risk Evaluation for TCE, EPA identified and assessed all known, intended, and reasonably foreseen industrial, commercial, and consumer uses of TCE in order to determine whether TCE as a whole chemical substance presents unreasonable risk to health and the environment. EPA determined that a substantial amount of the industrial, commercial, and consumer uses of TCE evaluated in the 2020 Risk Evaluation for TCE present 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 for TCE. 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 TCE 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 TCE, whereas the regulatory text applies to all 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 TCE, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for TCE 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 controlling industrial and commercial conditions of use that pertained only to the listed industrial and commercial conditions of use evaluated in the 2020 Risk Evaluation for TCE.

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 TCE 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 TCE, EPA identified non-cancer adverse effects from acute and chronic inhalation and dermal exposures to TCE, and for cancer from chronic inhalation and dermal exposures to TCE (Ref. 1). In the TCE risk characterization, the endpoints identified by EPA as the basis for the unreasonable risk determination in the Risk Conclusions were immunosuppression effects for acute inhalation and dermal exposures, and autoimmunity effects for chronic inhalation and dermal exposures (Ref. 1). Additional risks associated with other non-cancer adverse effects (

e.g.,

developmental toxicity, immunosuppression, liver toxicity, kidney toxicity, neurotoxicity, autoimmunity, and reproductive toxicity) were identified for acute and chronic inhalation and dermal exposures, as well as cancer (liver, kidney, and non-Hodgkin lymphoma) for chronic inhalation and dermal exposures. EPA also concluded, based on EPA's Guidelines for Carcinogen Risk Assessment (Ref. 41), that TCE is considered to be carcinogenic by all routes of exposure and calculated cancer risks from chronic inhalation and dermal exposures (Ref. 1). Unit IV. summarizes the health effects and the magnitude of the exposures.

To make the unreasonable risk determination for TCE, EPA evaluated exposures to potentially exposed or susceptible subpopulations including workers, ONUs, consumer users, and bystanders to consumer use by using reasonably available monitoring and modeling data for inhalation and dermal exposures. (Ref. 1). 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 VII.A.

For the 2020 Risk Evaluation for TCE, and as discussed in Unit II.D.1. and Unit III.A.3., EPA considered PESS. EPA identified the following groups as PESS: workers and ONUs, including men and women of reproductive age, adolescents, and biologically susceptible subpopulations; and consumer users (age 11 and older) and bystanders (of any age group, including infants, toddlers, children, and elderly), including biologically susceptible subpopulations. Additionally, older pregnant women are identified as especially susceptible to cardiac defects in their developing fetus based on

epidemiological data (Ref. 1). All PESS are included in the quantitative and qualitative analyses described in the 2020 Risk Evaluation for TCE and were considered in the determination of unreasonable risk for TCE (Ref. 1, 2). As discussed in Unit II.D. and Unit IV.B., the 2020 Risk Evaluation for TCE excluded the air and water exposure pathways to the general population from the published risk evaluations and may have caused some risks to be unaccounted for in the risk evaluation. EPA considers these groups a subset of the general population and categorizes them as fenceline communities; they may also be considered PESS. See Unit VII.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 address the unreasonable risk for TCE.

As required, EPA developed a proposed regulatory action and one or more primary alternative regulatory actions, which are described in Units V.A. and V.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 TCE at different points in the supply chain to eliminate exposures or restrict the availability of TCE and TCE-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 the effects of TCE on health, which is described in Unit IV. EPA also factored into its decisions, to the extent practicable: the effects of TCE on the environment and the magnitude of exposure to TCE of human beings and the environment, the benefits of TCE for various uses, and 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 VII. 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 TCE to be addressed under other statutes, such that a referral may be warranted under TSCA sections 9(a) or section 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 VI.B.), and setting proposed compliance dates in accordance with the requirements in TSCA section 6(d)(1) (described in the proposed and alternative regulatory action in Unit V.).

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 TCE, 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 V. Additional details related to how the requirements in this unit were incorporated into development of those actions are in Unit VI.

IV. Considerations of Health Effects of TCE

TSCA section 6(a) rules must be promulgated “in accordance with subsection (c)(2).” TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to “consider and publish a statement based on reasonably available information” with respect to listed criteria, including the effects and magnitude of exposure to human health and the environment, the benefits of the chemical substance for various uses, and the reasonably ascertainable economic consequences of the rule. Under TSCA section 6(c)(2)(B), EPA must “factor in, to the extent practicable,” the considerations under TSCA section 6(c)(2)(A) when selecting among prohibitions and other restrictions in TSCA section 6(a) rules. This section discusses the health effects of TCE. Other TSCA section 6(c)(2) considerations are discussed further in Unit VII.

EPA's analysis of the health effects of TCE is in the 2020 Risk Evaluation (Ref. 1). This unit presents a summary of that information and an explanation of how EPA considered that information in developing the proposed and alternative regulatory options.

TCE has a large database of human health toxicity data. The 2020 Risk Evaluation for TCE identified several endpoints, such as kidney toxicity, immunotoxicity, or developmental toxicity, and often a single endpoint was examined by multiple studies. For acute exposures, EPA identified non-cancer effects (developmental toxicity and immunosuppression). For chronic exposures, EPA identified non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity, reproductive toxicity, and developmental toxicity) as well as cancer (liver, kidney, and non-Hodgkin lymphoma), with kidney cancer identified as acting through a mutagenic mode of action (Ref. 1). As discussed in this unit, the 2020 Risk Evaluation for TCE contains quantitative risk estimates using several points of departure (PODs), including both the immunotoxicity endpoints as well as the more sensitive developmental toxicity endpoints, specifically fetal cardiac defects, and both demonstrate that TCE presents risk.

Additionally, in developing the 2020 Risk Evaluation for TCE, EPA analyzed

the reasonably available information to ascertain whether some human subpopulations may have greater exposure or greater susceptibility than the general population to the hazard posed by the chemical substance. Factors affecting susceptibility examined in the reasonably available studies on TCE include lifestage, sex, genetic polymorphisms, race/ethnicity, preexisting health status, lifestyle factors, and nutrition status. Groups of individuals for which one or several of these factors apply may be considered PESS (Ref. 1).

A. ECEL Value of 0.0011 ppm Based on Developmental Toxicity (Proposed)

Because TSCA section 6(c)(2)(B) directs EPA to factor in, to the extent practicable, the health effects of TCE under TSCA section 6(c)(2)(A), TSCA section 6(c) thereby provides EPA with the flexibility to tailor the regulatory restrictions to account for particular health effects identified in the underlying risk evaluation. With this consideration, EPA found that, in some cases, a regulatory option that could reduce exposures such that they would achieve the benchmark margin of exposure for the most sensitive non-cancer endpoint (developmental toxicity) would address any risk for other non-cancer endpoints. Older pregnant workers and ONUs, who may be especially susceptible to TCE- induced cardiac defects in their developing fetus, are classified as a PESS, and the associated POD and risk estimates were included in the 2020 Risk Evaluation in consideration of PESS groups. EPA has carefully considered the health effects of TCE on pregnant workers and ONUs as part of the Agency's development of proposed requirements that would be applicable to certain occupational conditions of use of TCE. In order for this rulemaking to appropriately address risk to all workers and ONUs exposed to TCE through the occupational conditions of use for which EPA is proposing an ECEL associated with a WCPP, EPA has factored in consideration of additional health effects applicable to PESS, including older pregnant workers and ONUs (the group identified as most susceptible to fetal cardiac defects) pursuant to TSCA section 6(c)(2), and is proposing an ECEL value of 0.0011 ppm based on developmental toxicity (Ref. 13).

In the risk characterization section of the 2020 Risk Evaluation for TCE, EPA acknowledged that fetal cardiac defects are an acute, non-cancer endpoint of concern for older pregnant women, while also acknowledging uncertainty surrounding the use of this endpoint to inform the determination of whether TCE presents unreasonable risk of injury to health for all affected human populations. In the 2020 Risk Evaluation for TCE, EPA presented the Agency's findings with respect to different endpoints and characterized the immunotoxicity endpoints as the “best overall” non-cancer endpoints for use in the risk conclusions and risk determination. The endpoints were characterized in this way precisely because of the quantitative uncertainties surrounding the use of the fetal cardiac defects endpoint and other considerations. Further, as noted in Unit II.D.1., EPA has received numerous comments on EPA's 2020 TSCA Risk Evaluation policy choice regarding endpoint selection that have raised concerns pertaining to political interference and scientific integrity, among other issues. Among the non-cancer adverse health effects, the drivers for EPA's whole chemical unreasonable risk determination for TCE under TSCA were identified as immunotoxicity, acute immunosuppression, and chronic autoimmunity from inhalation and dermal exposures (Ref. 2). EPA received significant feedback on this aspect of the 2020 Risk Evaluation for TCE, including focused attention on this issue from the SACC and public commenters reacting to the draft Risk Evaluation for TCE (Ref. 42). Moreover, based on the discussion included in the peer review report of the 2020 Risk Evaluation, EPA also concluded that reasonable scientists would not disallow the use of the fetal cardiac defects studies, and that therefore other EPA program reliance on the fetal cardiac defects endpoint is scientifically valid (

e.g.,

IRIS).

The 2020 Risk Evaluation for TCE identified the developmental toxicity endpoint of fetal cardiac defects, which presents a lower POD than the immunotoxicity endpoints. The magnitude of the unreasonable risk from exposures to TCE would have been greater had the Agency relied upon the developmental toxicity endpoint (Ref. 1). Specifically, EPA identified the risk of fetal cardiac defects most strongly associated with offspring of older mothers, and therefore included risk estimates for fetal cardiac defects that account for susceptible mothers and their offspring in addition to PESS groups with other susceptibilities (

e.g.,

diabetes, infection status, drug exposure, stress, and metabolic sensitivity due to increased enzymatic activity of cytochrome P450 2E1 (CYP2E1) (Ref. 1).

EPA developed the ECEL for the most sensitive health endpoint (developmental toxicity) in support of risk management efforts on TCE under TSCA, to identify that ambient exposures that are kept at or below the 8-hour ECEL of 0.0011 ppm would protect against risk of injury to health due to fetal cardiac defects, if those levels can be achieved. In addition, EPA expects that at the acute non-cancer ECEL of 0.0011 ppm, any potentially exposed person in the workplace would be protected against other non-cancer effects resulting from occupational exposures, as well as excess risk of cancer (Ref. 13). EPA expects that if a facility were able to meet the ECEL (0.0011 ppm) requirement associated with the WCPP under the proposed regulatory action outlined in Unit V.A.2., it would protect PESS during the phaseout period before the full prohibition.

B. ECEL Value of 0.0040 ppm Based on Immunotoxicity (Primary Alternative)

In other risk management actions under TSCA section 6, EPA has proposed basing its worker protection requirements, such as an ECEL, on a single acute or chronic exposure endpoint that provided the basis for the unreasonable risk determination (Ref. 40). While EPA is proposing a different basis for the ECEL for the WCPP for TCE (0.0011 ppm) (to protect a sensitive PESS), EPA recognizes that among the non-cancer adverse health effects of TCE, the drivers for EPA's whole chemical unreasonable risk determination for TCE under TSCA were identified as immunotoxicity, namely acute immunosuppression and chronic autoimmunity from inhalation and dermal exposures (Ref. 2). For this reason, the primary alternative regulatory action provided by EPA includes a WCPP with a different ECEL (0.0040 ppm), based on the endpoint that drives the unreasonable risk. As described in more detail in Unit V.B.2., reducing exposures to or below the ECEL of 0.0040 ppm would address that component of the unreasonable risk of injury to health from TCE that is driven by inhalation exposures in an occupational setting (Refs. 1, 14). If ambient exposures are kept at or below the 8-hour ECEL of 0.0040 ppm, EPA expects that workers and ONUs would be protected against not only the chronic non-cancer effects for autoimmunity described in this unit, but also effects resulting from acute non-cancer exposure (immunosuppression) and cancer.

As described in Unit V.A.2., for the ECEL value of 0.0011 ppm, proposed as

part of the WCPP, EPA requests comment on the use of TSCA section 6(c)(2) to tailor the risk management actions where necessary to protect PESS. Also, as described in Unit V.B.2., EPA is requesting comment on the use of the ECEL value of 0.0040 ppm in the WCPP in the alternative regulatory action. Specifically, EPA is requesting comment on the selection of the fetal cardiac defects endpoint for the ECEL of 0.0011 ppm in the proposed regulatory action, rather than the immunotoxicity endpoint on which the unreasonable risk determination is based, which would result in an ECEL of 0.0040 ppm. EPA is also requesting comment on additional ways to protect workers and ONUs who are or may become pregnant.

V. Proposed and Primary Alternative Regulatory Actions

This unit describes the proposed regulatory action by EPA so that TCE 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 TCE, the proposed regulatory action is described in Unit V.A. and the primary alternative regulatory action considered is described in Unit V.B. An overview of the proposed regulatory action and primary alternative regulatory action for each condition of use is in Unit V.C. The rationale for the proposed and primary alternative regulatory actions and associated compliance timeframes are discussed in this unit and in more detail in Unit VI.A.

A. Proposed Regulatory Action

EPA is proposing under TSCA section 6(a) to: Prohibit all manufacture (including import), processing, distribution in commerce, and industrial and commercial use of TCE for all uses (including all consumer uses), with longer timeframes and workplace controls for certain processing and industrial and commercial uses (including proposed phaseouts and TSCA section 6(g) exemptions); prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works with a 50-year TSCA section 6(g) exemption for cleanup projects; and establish recordkeeping and downstream notifications requirements. Prohibitions on manufacturing (including import) and processing, including staggered implementation timeframes to account for the supply chain, are outlined in Unit V.A.1.a.; prohibitions on industrial and commercial uses and distribution in commerce are outlined in Unit V.A.1.b.; and prohibitions related to consumer uses are outlined in Unit V.A.1.c.

EPA is proposing longer compliance timeframes (with workplace controls) for prohibitions on certain conditions of use. The timeframe for a prohibition or phaseout under TSCA section 6(d) must begin as soon as practicable, but not later than 5 years, with the full implementation of the prohibition or phase-out requirements occurring as soon as practicable and providing for a reasonable transition period. For a TSCA section 6(g) exemption for a specific condition of use, EPA must establish a time limit as reasonable on a case-by-case basis as long as the exemption meets the criteria under TSCA section 6(g)(1). First, EPA is proposing to prohibit the manufacturing (including import) and processing of TCE as an intermediate for the manufacture of HFC-134a through an 8.5-year phaseout, as outlined in Unit V.A.1.d. Second, EPA is proposing a 10-year phaseout for the industrial and commercial use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production for Federal agencies and their contractors, conditioned on a final pre-launch test within 5 years of rocket booster nozzles that have been produced without using TCE, as outlined in Unit V.A.1.e. Third, EPA is proposing a time-limited exemption for 10 years under a TSCA section 6(g) exemption related to prohibitions on the industrial and commercial use of TCE as a processing aid for battery separator manufacturing, as outlined in Unit V.A.3.b.i. Fourth, EPA is proposing a time-limited exemption for 10 years under a TSCA section 6(g) exemption related to prohibitions on industrial uses of TCE for DoD vessel requirements for potting, bonding and sealing compounds, and bonding and cleaning requirements for naval combat systems, radars, sensors, equipment, and fabrication and prototyping processes, as outlined in Unit V.A.3.b.ii. Fifth, EPA is proposing a time-limited exemption for 50 years under a TSCA section 6(g) exemption related to prohibitions on the industrial and commercial use of TCE in laboratory use for essential laboratory activities and some research and development activities, as outlined in Unit V.A.3.b.iii. Sixth, EPA is proposing a time-limited exemption for 7 years under a TSCA section 6(g) exemption related to prohibitions on the industrial and commercial use of TCE as a solvent in closed loop vapor degreasing necessary for human-rated rocket engine cleaning by NASA and its contractors. Seventh, EPA is proposing a time-limited exemption for 10 years under a TSCA section 6(g) exemption for emergency industrial and commercial use of TCE for specific conditions of use which are critical or essential in furtherance of NASA's mission and for which no technically and economically safer alternative is available. Where conditions of use would be prohibited under timeframes longer than one year, EPA's proposal aims to align with elements of existing OSHA regulations and industrial hygiene best practices to the extent possible by implementing a Workplace Chemical Protection Program (WCPP). The WCPP includes requirements for an inhalation exposure limit and glove requirements to limit exposure to TCE until the prohibitions take effect, as outlined in Unit V.A.2. Lastly, EPA is proposing to prohibit certain disposal of TCE (specifically, the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works), as outlined in Unit V.A.1.f., with a time limited 50-year exemption for cleanup projects as outlined in Unit V.A.3.b.iv; and establish recordkeeping and downstream notification requirements, as outlined in Unit V.A.4. EPA requests comment on the applicability to the private sector of proposed regulatory actions pertaining specifically to Federal agencies, namely industrial uses for DoD vessel requirements and closed-loop batch vapor degreasing for rayon fabric scouring for rocket booster nozzle production. EPA requests comment on the extent to which the private sector would be affected by a prohibition on these uses.

1. Prohibitions of Manufacturing, Processing, Distribution in Commerce, Use, and Disposal

a. Prohibitions on Manufacturing (Including Import) and Processing of TCE

EPA is proposing to prohibit the manufacturing (including import) and processing of TCE based on the unreasonable risk to workers and ONUs driven by these conditions of use (Ref. 2). As the manufacture and processing of TCE presents and unreasonable risk to health in the United States, the manufacture and processing of TCE for export would also be prohibited in accordance with TSCA section 12(a)(2).

As discussed in Units III.B.3. and VI.A., based on the Agency's 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 occupational environments and activities that occur in manufacturing (including import) and processing conditions of use, and the irreversible health effects associated with TCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk.

EPA is proposing that the prohibitions on manufacturing (including import) and processing of TCE would follow a staggered schedule, due to supply chain considerations. EPA proposes that the compliance dates for the proposed prohibitions described in this unit, such that the requirements would come into effect in 90 days (3 months) for manufacturers and in 180 days (6 months) for processors, with different timeframes related to specific conditions of use. Specifically, for processing TCE as a reactant/intermediate, EPA is proposing that the compliance dates for the proposed prohibitions described in this unit would come into effect in 1.5 years for manufacturers and 2 years for processors. There are additional exceptions from the prohibition for the manufacturing and processing associated with certain processing and industrial and commercial uses, including those described later in this unit (for which EPA is proposing longer compliance timeframes, including phaseouts (see Units V.A.1.b., d., and e.) or time-limited exemptions under TSCA section 6(g) (see Unit V.A.3.b.)). The rationale for longer timeframes for certain conditions of use is described in Unit VI.A.1.

b. Prohibitions on Industrial and Commercial Use and Distribution in Commerce of TCE

EPA is proposing to prohibit the industrial and commercial use of TCE, based on the unreasonable risk to workers and ONUs driven by these conditions of use (Ref. 2). As discussed in Units III.B.3. and VI.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 represented by industrial and commercial uses of TCE, and the irreversible health effects associated with TCE exposures, EPA has determined that prohibition is the best way to address the unreasonable risk. However, in consideration of the challenges several sectors may encounter in adopting alternatives to TCE, EPA is proposing longer compliance timeframes for certain uses under this prohibition.

EPA is proposing compliance dates for the proposed prohibitions that would come into effect for most industrial and commercial users 270 days after the publication date of the final rule. However, EPA is proposing longer compliance timeframes under this prohibition for some industrial and commercial uses and for the associated manufacturing (including import), processing, and distribution in commerce. Specifically, for two batch vapor degreasing conditions of use (open-top and closed-loop), EPA is proposing that the compliance dates for the proposed prohibitions described in this unit would come into effect in 180 days for manufacturers, in 270 days (9 months) for processors, specifically for processing into a formulation and for recycling, and in 1 year for the industrial and commercial uses of TCE in open-top and closed-loop batch vapor degreasers (see Unit III.B.1.c.i. and ii. for descriptions of these conditions of use and Unit VI.A.1. for a rationale for the slightly longer timeframe). For a sub-set of the closed-loop batch vapor degreasing condition of use (industrial and commercial use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production for Federal agencies and their contractors) EPA is proposing that the compliance dates for the proposed prohibitions described in this unit would come into effect in five or 10 years for manufacturers, processors, distributors, and industrial and commercial users, depending on whether the conditions of the phaseout are met (see Unit V.A.1.e. for a description of the conditions of this proposed exemption, and Unit VI.A.1. for the rationale for this timeframe). Also, EPA is proposing that the compliance dates for the proposed prohibitions described in this unit would come into effect for commercial use of TCE as a processing aid in 1.5 years for manufacturers, in 2 years for processors, and in 2 years for industrial and commercial use of TCE in: processing aid in process solvent used in battery manufacture; process solvent used in polymer fiber spinning, fluoroelastomer manufacture and Alcantara manufacture; extraction solvent used in caprolactam manufacture; and precipitant used in beta-cyclodextrin manufacture (see Unit III.B.1.c.xvi. for a description of this condition of use and Unit V.A.1. for a rationale for the different timeframe).

To aid with implementation of the compliance dates for the proposed prohibitions on manufacturing, processing, and industrial and commercial use of TCE, and ensure that those prohibitions effectively address the unreasonable risk identified, EPA is also proposing prohibitions on distribution in commerce of TCE. Generally, for most conditions of use EPA is proposing that the compliance date for the proposed prohibition on distributors in commerce of TCE would come into effect 180 days (6 months) following publication of the final rule. In instances where EPA is proposing a prohibition on manufacturing and processing TCE for a particular industrial and commercial use that is later than 180 days after publication of the final rule, the compliance date for the proposed prohibition on distribution in commerce would be the same as the compliance date of the proposed prohibition on manufacturing and processing TCE.

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, that a prohibition on the processing of TCE 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 also requests comment on whether it should consider a

de minimis

level of TCE in formulations to account for impurities (

e.g.,

0.1% or 0.5%) when finalizing the prohibitions described in this unit, and, if so, information on and rationale for any level that should be considered

de minimis.

When proposing the compliance dates described in this unit as required under TSCA section 6(d), EPA considered irreversible health effects associated with TCE 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.

c. Prohibitions of Manufacturing, Processing, and Distribution in Commerce of TCE for Consumer Use

The consumer uses evaluated in the 2020 Risk Evaluation for TCE constitute all known, intended, and reasonably foreseen consumer uses of TCE. As described in this unit, EPA is proposing to prohibit all manufacturing (including import) and processing of TCE to address the unreasonable risk to workers and ONUs driven by those conditions of use (Ref. 2). EPA does not believe any delays are necessary for prohibitions on manufacture (including import), processing, or distribution in commerce of TCE for consumer use. EPA notes that not only did all but one of the 24 consumer uses of TCE evaluated in the 2020 Risk Evaluation for TCE support the unreasonable risk determination for TCE (Refs. 1, 2), but also the manufacture (including import) and processing of TCE for consumer uses generally supports EPA's unreasonable risk determination for workers and ONUs, as further discussed in Unit V.A. For these reasons, and based on considerations of the severity of the hazards of TCE, EPA is proposing to prohibit the manufacturing (including import), processing, and distribution in commerce of TCE for all uses, which includes all consumer uses.

EPA is proposing that the compliance dates for the proposed prohibitions described in this unit relevant to consumer uses would come into effect for manufacturers 90 days (3 months) and for processors 180 days (6 months) after the publication date of the final rule in the

Federal Register

. EPA is also proposing prohibitions on distribution in commerce of TCE for consumer uses to aid with effective implementation of the prohibitions on manufacturing and processing, and to address the unreasonable risk to consumers and bystanders. EPA proposes that the compliance dates for the proposed prohibition on distribution in commerce of TCE for consumer use would come into effect 180 days (6 months) after the publication date of the rule in the

Federal Register

. EPA considered the risk of irreversible health effects associated with TCE exposure when proposing these 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, or for implementing the use of substitutes; comments should include the considerations described in Unit V.A.1.b. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

EPA also requests comment on whether it should consider a

de minimis

level of TCE in formulations to account for impurities (

e.g.,

0.1% or 0.5%) when finalizing the prohibitions described in this unit, and, if so, information on and rationale for any level that should be considered

de minimis.

d. Phaseout of TCE for Processing as an Intermediate for the Manufacture of HFC-134a.

As described in this unit, EPA is proposing a longer phaseout timeframe for the manufacturing (including import) and processing of TCE as an intermediate for the m

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