74712 Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Proposed Rules 

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); 


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• 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 HighSpeed 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); 


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• 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); 


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• 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 

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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 pretreatment, 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 nonHodgkin 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 closedloop 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 


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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/m3) 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 peruser 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 mm 

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 prelaunch 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 offshoring 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 offshoring 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 


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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-topregnancy) and menstrual cycle 

disturbances in women with TCE 

exposures. Human studies have 

consistently reported vestibular systemrelated 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 noncancer effects, and therefore monetized 

benefits are likely underestimated. 

EPA does estimate that there are 

52,595 workers and occupational nonusers (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 


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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 substancespecific OSHA standards further 

mitigate residual risk that could be 

present due to exposure at the PEL. 

Many OSHA PELs have not been 

updated since they were established in 

1971, including the PEL for 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 


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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 


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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 noncancer endpoints under TSCA of 

immunosuppression and autoimmunity, 

respectively (Refs. 14, 46, 1). The ECEL 

of 0.0040 ppm is based on elevated antidouble 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- 


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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 longterm exposure to TCE, including noncancer 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 


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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 riskrelated factors, including, but not 

limited to: the effects of the chemical 

substance on health (including cancer 

and non-cancer risks) and human 

exposure to the substance under the 

conditions of use (including duration, 

magnitude, and frequency of exposure); 

the effects of the chemical substance on 

the environment and environmental 

exposure under the conditions of use; 

the population exposed (including any 

PESS); the severity of hazard (including 

the nature of the hazard, the 

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 TCEcontaining 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 EPAadministered 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 


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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 timelimited exemption from a requirement 

of a TSCA section 6(a) rule for a specific 

condition of use if EPA finds that: (1) 

The specific condition of use is a critical 

or essential use for which no technically 

and economically feasible safer 

alternative is available, taking into 

consideration hazard and exposure; (2) 

Compliance with the requirement, as 

applied with respect to the specific 

condition of use, would significantly 

disrupt the national economy, national 

security, or critical infrastructure; or (3) 

The specific condition of use, as 

compared to reasonably available 

alternatives, provides a substantial 

benefit to health, the environment, or 

public safety. Based on reasonably 

available information, EPA has analyzed 

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 


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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 lowerincome 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 noncancer hazard identified for nonreproductive 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. 


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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. 


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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 BetaCyclodextrin 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 


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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. 


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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 pretreatment, 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 noncancer 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 


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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 


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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 noncancer endpoint (developmental 

toxicity) would address any risk for 

other non-cancer endpoints. Older 

pregnant workers and ONUs, who may 

be especially susceptible to TCEinduced 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 noncancer 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 


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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 timelimited 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 pretreatment, 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 closedloop 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 


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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 


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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 manufacture of 

HFC–134a (1,1,1,2-Tetrafluroethane; 

CAS Number 811–97–2). EPA is 

proposing an 8.5-year phaseout subject 

to the requirements discussed in this 

unit. All other processing of TCE as a 

reactant/intermediate would be subject 

to the proposed prohibitions described 

in Unit V.A.1.b. EPA is proposing to 

require a phaseout for processing of TCE 

as an intermediate for the manufacture 

of HFC–134a, which EPA expects would 

begin at the final rule’s effective date 

and end 8.5 years after the publication 

of the final rule. Associated with this 

phaseout, EPA would require the 

establishment of the TCE WCPP, 

outlined in Unit V.A.2., within 6 

months after publication of the final 

rule, as workplace protections during 

the period of the phaseout. To set the 

phaseout volumes, EPA would require 

any facility processing TCE as an 

intermediate to manufacture HFC–134a 

in the United States to establish a 

baseline of the annual quantity of TCE 

processed by the facility as a feedstock 

to manufacture HFC–134a. EPA is 

proposing to require that within 6 

months after the publication of the final 

rule the manufacturer could use the 

average of any 12 consecutive months in 

the 36 months preceding the publication 

of the final rule to calculate their 

baseline, based on records that 

demonstrate how the baseline annual 

volume was calculated. Following the 

establishment of a baseline volume, the 

regulated entity would then be required 

to implement a 4-step phaseout process; 

specifically, the phaseout would be a 25 

percent reduction from the baseline 

volume every 2 years as follows: (1) 2.5 

years after the publication of the final 

rule each manufacturer of HFC–134a 

who processes TCE as an intermediate 

would not be permitted to process TCE 

as an intermediate at an annual volume 

greater than 75 percent of the baseline; 

(2) 4.5 years after the publication of the 

final rule each manufacturer of HFC– 

134a who processes TCE as an 

intermediate would not be permitted to 

process TCE as an intermediate at an 

annual volume greater than 50 percent 

of the baseline; (3) 6.5 years after the 

publication of the final rule each 

manufacturer of HFC–134a who 

processes TCE as an intermediate would 

not be permitted to process TCE as an 

intermediate at an annual volume 

greater than 25 percent of the baseline; 

and (4) 8.5 years after the publication of 

the final rule each manufacturer of 

HFC–134a would be prohibited from 

processing TCE as an intermediate. 

EPA notes that the prohibition for 

manufacture (including importing), 

processing, and distribution in 

commerce of TCE for this condition of 

use would occur after 8.5 years to 

account for availability of TCE through 

the supply chain during the period of 

the phaseout of processing of TCE as an 

intermediate for the manufacture of 

HFC–134a. This timeframe would be 

longer than the prohibitions on 

manufacturing and processing TCE 

described in Unit V.A.1.a. 

EPA is also proposing to require 

regulated entities to keep records of the 

annual quantity of TCE purchased and 

processed from the year 2023 until the 

termination of all processing of TCE as 

an intermediate. EPA requests comment 

on whether additional recordkeeping 

requirements are warranted or 

additional time would be needed, for 

example, to begin the phaseout of 

processing TCE as an intermediate for 

the manufacture of HFC–134a. 

EPA notes, per TSCA section 

6(c)(2)(C), that although the use of TCE 

to produce HFC–134a would be 

prohibited eventually due to 

unreasonable risk, the use of PCE to 

produce HFC–134a is proposed to 

continue in perpetuity under a WCPP 

(88 FR 39652, July 16, 2023). As such, 

the refrigerant would remain available 

while protecting workers. 


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e. Phaseout of TCE in industrial and 

Commercial Use as a Solvent for ClosedLoop Batch Vapor Degreasing for Rayon 

Fabric Scouring for Rocket Booster 

Nozzle Production 

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. This is the 

industrial and commercial use of TCE in 

a closed-loop batch vapor degreaser to 

clean, or ‘scour,’ rayon fabric to remove 

sizing (i.e., protective filler or glaze on 

textiles), oils, and other contaminants 

from the rayon fabric that is used to line 

the inside of rocket booster nozzles; the 

degreasing is essential in preparing the 

rayon fabric before a carbonization 

process ahead of being used in the 

rocket booster nozzles. If contaminants 

are not removed properly from the 

rayon, the result could include nozzle 

failure (Ref. 43). More information on 

this use and the rationale for the 

phaseout are in Unit VI.A.1. For this 

sub-set of the vapor degreasing 

condition of use, when conducted by 

Federal agencies and their contractors, 

EPA is proposing a 10-year phaseout 

subject to the requirements discussed in 

this unit. (All other industrial and 

commercial use of TCE as a solvent for 

vapor degreasing, including use of TCE 

in closed-loop batch vapor degreasing of 

other parts or materials, would be 

subject to the proposed prohibitions 

described in Unit V.A.1.b.). For the 

phaseout, EPA is proposing that within 

5 years of the publication date of the 

final rule the Federal agency that is the 

end user of the rayon fabric for rocket 

booster nozzle production (e.g., the U.S. 

Department of Defense (DOD) or the 

NASA) would need to conduct a final 

pre-launch test of rocket boosters 

without using TCE; this test is further 

discussed in Unit VI.A.1.a. By 10 years 

from the publication date of the final 

rule, the phaseout would be complete 

and industrial and commercial use of 

TCE as a solvent for closed-loop batch 

vapor degreasing, including for rayon 

fabric scouring for end use in rocket 

booster nozzle production by Federal 

agencies and their contractors, would be 

prohibited. As part of this phaseout, 

EPA would require a TCE WCPP, 

described in Unit V.A.2., within 6 

months after publication of the final 

rule, as workplace protections during 

the period of the phaseout until the full 

prohibition takes effect. Additionally, 

this phaseout would include 

recordkeeping requirements beginning 6 

months after publication of the final 

rule related to the rayon fabric scouring 

for end use in rocket booster nozzle 

production. The entity must have 

records indicating that their closed-loop 

batch vapor degreasing with TCE is for 

rayon fabric scouring for end use in 

rocket booster nozzle production for a 

Federal agency or a contractor. 

Beginning 5 years after the publication 

of the final rule, to continue to use TCE 

for closed-loop batch vapor degreasing 

for this specific use, the user must have 

records from a Federal agency 

indicating that a final pre-launch test for 

the rayon fabric scouring has been 

conducted with an alternative chemical 

or process. 

f. Prohibition of Disposal of TCE to 

Industrial Pre-Treatment, Industrial 

Treatment, or Publicly Owned 

Treatment Works 

Due to the unreasonable risk to 

workers exposed to TCE while 

performing industrial wastewater pretreatment and treatment, EPA is 

proposing to prohibit this mode of 

disposal of TCE (i.e., generated 

wastewater that contains TCE that is 

collected on site or transported to a 

third party site, and includes the mixing 

of TCE with wastewater and the 

discharge of TCE-contaminated 

wastewater) (description of disposal for 

the purposes of this rulemaking is in 

Unit III.B.2.d.). TSCA section 6(a) 

provides EPA the authority to prohibit 

or otherwise regulate any manner or 

method of disposal of a chemical 

substance by its manufacturer, 

processor, or any other person who uses 

or disposes of it for commercial 

purposes. EPA is proposing to prohibit 

the disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works. 

Facilities generating solid waste with 

TCE concentrations above the RCRA 

regulatory level of 0.5 mg/L using the 

Toxicity Characteristic Leaching 

Procedure (see 40 CFR 261.24) would 

need to manage TCE separately from 

wastewater and dispose of TCE through 

a different disposal mechanism, due to 

the prohibition in RCRA against using 

dilution as a substitute for appropriate 

treatment (see 40 CFR 268.3), while 

following the appropriate RCRA 

requirements when handling waste 

containing TCE. Dilution of hazardous 

waste (including by mixing it with 

wastewater) as a substitution for 

adequate treatment is prohibited under 

RCRA (see 40 CFR 268.3). 

EPA is proposing that the compliance 

date for the proposed prohibition 

described in this unit would be 270 

days (9 months) after the publication 

date of the final rule for manufacturers, 

processors, distributors, and industrial 

and commercial users disposing of TCE 

to wastewater. EPA has no information 

indicating that the proposed compliance 

dates would not be practicable for 

purposes of finding an alternative 

disposal method, or that additional time 

would be needed, for example, for 

facilities to transition to an alternative 

disposal method. EPA’s understanding 

is that only 1 percent of TCE is disposed 

of as wastewater. However, EPA 

requests comment on whether the 270- 

day proposed compliance date is 

practicable, whether additional time is 

needed, for example, for a regulated 

entity to implement a change to their 

disposal processes or to transition to 

alternative disposal methods, including 

what those alternative disposal methods 

would be, and their cost and feasibility. 

EPA is also proposing, as described in 

Unit V.A.3., a time-limited exemption 

for 50 years under TSCA section 6(g) for 

disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works for the 

purpose of cleanup projects of TCEcontaminated groundwater and other 

wastewater. 

2. WCPP for Certain Conditions of Use 

a. Overview 

As described in Unit III.B.3., EPA is 

required to issue a regulation applying 

one or more of the TSCA section 6(a) 

requirements to the extent necessary so 

that the unreasonable risk of injury to 

health or the environment from a 

chemical substance is no longer 

presented. The TSCA section 6(a) 

requirements provide EPA the authority 

to limit or restrict a number of activities, 

alone or in combination, including the 

manufacture, processing, distribution in 

commerce, commercial use, and 

disposal of the chemical substance. 

Given this authority, EPA may find it 

appropriate in certain circumstances to 

propose requirements under a WCPP for 

certain occupational conditions of use 

(e.g., manufacturing, processing, 

industrial and commercial use). 

However, for the reasons described in 

Unit VI., including the challenges of 

reliably reducing exposure below the 

ECEL and being able to monitor at the 

appropriate action level, EPA’s 

proposed requirement for the TCE 

WCPP is that owners or operators 

ensure that no person is exposed to TCE 

in excess of the ECEL as an 8-hr TWA 

to the extent possible (supported by 

documentation further described in Unit 

V.A.2.d.i.) rather than (as has been 

proposed in other rules under TSCA 

section 6) a requirement that exposures 

do not exceed the ECEL. Due to these 


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challenges, as well as the severity of the 

hazard from TCE, EPA notes that longterm implementation of the WCPP 

would not be a feasible means of 

addressing TCE unreasonable risk and 

thus EPA believes that prohibition of 

the COUs would ultimately be necessary 

to address the unreasonable risk. 

Furthermore, when selecting among 

proposed prohibitions and other 

restrictions that would apply to those 

occupational conditions of use, EPA has 

also factored in considerations relating 

to health effects on PESS, including on 

older pregnant workers and ONUs (the 

group identified as most susceptible to 

fetal cardiac defects), further discussed 

in Units V.A.1. and VI.A. For the time 

period before which a prohibition 

would become effective, for several 

conditions of use, EPA is proposing a 

TCE WCPP to address to the extent 

possible the unreasonable risk. The 

WCPP would include a TCE ECEL of 

0.0011 ppm, the associated 

implementation requirements, and may 

include other components, such as 

dermal protection, as described in this 

unit. 

EPA uses the term ‘‘potentially 

exposed person’’ in this unit and in the 

regulatory text to include workers, 

ONUs, employees, independent 

contractors, employers, and all other 

persons in the work area who may be 

exposed to TCE under the conditions of 

use for which a WCPP would apply. 

EPA’s intention is to require a 

comprehensive WCPP that would put 

additional protections in place to reduce 

the unreasonable risk from TCE to 

potentially exposed persons directly 

handling the chemical or in the area 

where the chemical is being used, until 

the prohibition compliance date. 

Similarly, the risk evaluation for TCE 

did not distinguish between employers, 

contractors, or other legal entities or 

businesses that manufacture, process, 

distribute in commerce, use, or dispose 

of TCE. EPA uses the term ‘‘owner or 

operator’’ to describe the entity 

responsible for implementing the WCPP 

for workplaces where an applicable 

condition of use is occurring and TCE 

is present. The term includes any 

person who owns, leases, operates, 

controls, or supervises such a 

workplace. 

An ECEL is a risk-based inhalation 

exposure threshold. The ECEL would be 

accompanied by monitoring, training, 

recordkeeping, and other requirements 

so that exposures to TCE are reduced to 

the extent possible (as supported by 

documentation further described in Unit 

V.A.2.d.i.). With an ECEL, the WCPP 

provides the least uncertainty regarding 

the protection afforded to workers, 

requires regulated entities to consider 

more protective controls in the 

hierarchy, and lessens the burden on 

workers. Under this proposal, regulated 

entities would have some flexibility in 

the manner in which they implement 

modifications, within certain 

parameters outlined in this unit, or 

otherwise aim to prevent exceedances of 

the ECEL at their facilities. Therefore, 

EPA generally refers to the ECEL and 

ancillary requirements as a nonprescriptive approach. This unit 

includes a summary of the proposed 

TCE WCPP, including a description of 

the proposed ECEL of 0.0011 ppm; 

proposed implementation requirements 

and an EPA ECEL action level; proposed 

monitoring requirements; a description 

of potential exposure controls, which 

consider the hierarchy of controls; 

information that may be used to inform 

respirator selection; proposed glove 

requirements; and additional 

requirements proposed for 

recordkeeping, and worker training, 

participation, and notification. This unit 

also describes proposed compliance 

timeframes for these proposed 

requirements. 

EPA does not believe that long-term 

implementation of the WCPP would be 

a feasible means of addressing 

unreasonable risk indefinitely; thus 

prohibition of the use of TCE for 

affected COUs is ultimately necessary to 

address the risk so that it is no longer 

unreasonable, due to the severity of the 

hazard, the magnitude of the exposures, 

and the challenges of consistently 

reducing exposures below the low TCE 

ECEL in a way that is consistent with 

the hierarchy of controls, further 

described in Unit VI.A.1. However, for 

the conditions of use which would 

continue for longer than a year, as well 

as during the proposed TSCA section 

6(g) time-limited exemption, EPA is 

proposing the WCPP to reduce to the 

extent possible the unreasonable risk 

from TCE during the time period before 

compliance dates for the proposed 

prohibition would come into effect. EPA 

is not proposing the WCPP for uses that 

would be prohibited within 1 year from 

the effective date of the final rule. Based 

on reasonably available information, 

EPA expects that the ECEL is likely to 

be exceeded and that compliance with 

the WCPP would require large 

investments into PPE and engineering 

controls at facilities. For this reason, 

EPA’s proposal aims to encourage 

facilities engaged in uses that would be 

prohibited within a year from 

finalization to focus their resources on 

the transition to alternatives to TCE. 

EPA is requesting comment on how 

entities could demonstrate that they are 

reducing exposures to the extent 

possible (including considerations for 

technological feasibility) and is also 

requesting comment on whether EPA’s 

requirement should be that entities 

ensure that exposures are reduced 

below the ECEL, rather than to the 

extent possible or lowest achievable 

level described further in Unit V.A.2.d.i. 

Should regulated entities be able to 

consistently demonstrate compliance 

with an ECEL through effective controls, 

EPA requests comments regarding 

replacing the proposed prohibitions 

with compliance with the WCPP. 

b. Existing Chemical Exposure Limit 

(ECEL) 

i. ECEL and ECEL Action Level 

To reduce exposures in the workplace 

and eliminate the unreasonable risk of 

injury to health resulting from 

inhalation exposures to TCE identified 

under the occupational conditions of 

use in the TSCA 2020 Risk Evaluation 

for TCE, EPA is proposing an ECEL of 

0.0011 parts per million (ppm) (0.0059 

mg/m3) for inhalation exposures to TCE 

as an 8-hour TWA. As described in Unit 

IV.A., this ECEL is based on 

developmental toxicity, the most 

sensitive acute and chronic non-cancer 

health endpoint, specifically calculated 

based on the occupational acute, noncancer human equivalent concentration 

(HEC) for fetal cardiac defects (Ref. 13). 

EPA is proposing to establish 

requirements for an ECEL as part of the 

WCPP until the prohibition compliance 

date for certain conditions of use that 

would be permitted to continue for 

longer than a year after the effective date 

of the final rule, including the 

conditions of use described in Unit 

V.A.1.a., as well as the conditions of use 

that would be subject to the phaseout 

described in Unit V.A.1.d. and the 

TSCA section 6(g) exemptions described 

in Unit V.A.3. 

Each owner or operator of a 

workplace where these conditions of 

use occur would be responsible for 

compliance with the ECEL and the 

associated requirements. EPA’s 

description for how the requirements 

related to an ECEL would reduce the 

unreasonable risk resulting from 

inhalation exposures and the rationale 

for this regulatory approach is outlined 

in Units III.B.3. and V.A. 

In order for this rulemaking to 

appropriately reduce risk to all 

potentially exposed persons that may be 

exposed to TCE through the 

occupational conditions of use for 

which EPA is proposing compliance 

with the WCPP as a protection measure, 


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EPA has factored in consideration of 

additional health effects applicable to 

PESS pursuant to TSCA section 6(c)(2), 

outlined in Unit VI.A. EPA developed 

the ECEL for the most sensitive health 

endpoint (fetal cardiac defects) in 

support of risk management efforts on 

TCE under TSCA, to identify at what 

level ambient exposures would protect 

against unreasonable risk of injury to 

health due to fetal cardiac defects. The 

level identified is an 8-hour ECEL of 

0.0011 ppm, which, when possible to 

achieve, is the concentration at which 

an adult human would be unlikely to 

experience the specified adverse effects 

if exposed during a working lifetime, 

including susceptible subpopulations. 

In addition, 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). However, as noted in 

Unit IV., EPA does not believe that longterm implementation of the WCPP with 

this low ECEL would be a feasible 

means of addressing unreasonable risk 

indefinitely, and EPA is uncertain if the 

ECEL and associated action level can be 

met reliably as discussed further in Unit 

VI.A.1. 

EPA invites comment on the existing 

practices (e.g., engineering controls, 

administrative controls, PPE) involving 

TCE for the conditions of use listed in 

Unit V.A.1.a., Unit V.A.1.d., and Unit 

V.A.3., whether activities may take 

place in closed systems, and the degree 

to which users of TCE in these sectors 

could successfully implement the 

WCPP, including an ECEL of 0.0011 

ppm for TCE, dermal protection, and 

ancillary requirements described in Unit 

IV.A. EPA acknowledges that reducing 

and accurately detecting exposures from 

the current OSHA PEL of 100 ppm to 

the proposed TSCA ECEL of 0.0011 ppm 

would be very difficult. EPA also invites 

comment on the potential to develop 

future technologies (e.g., engineering 

controls, administrative controls, PPE) 

involving TCE for the conditions of use 

listed in Unit V.A.1.a., Unit V.A.1.d., 

and Unit V.A.3., that would facilitate 

successful implementation of the WCPP, 

including an ECEL of 0.0011 ppm for 

TCE, dermal protection, and ancillary 

requirements described in Unit IV.A. 

EPA is also requesting comment on the 

feasibility of controlling worker 

exposures to TCE at or below the 

proposed ECEL, and the accuracy of 

measurements at this level. This is 

important for determining whether there 

are realistic and effective exposure 

controls that can be used by industry for 

effectively controlling exposures to 

levels at or below the ECEL. To the 

extent time is needed to ensure methods 

are available to accurately measure TCE 

at or below the ECEL, EPA is requesting 

comment on whether a phased approach 

to an ECEL is desirable; that is, an 

approach that would establish a 

timeframe for meeting the ECEL as well 

as a shorter timeframe for meeting a 

concentration level higher than the 

ECEL (but lower than the PEL) that is 

currently considered achievable. EPA 

welcomes data or information to 

demonstrate that meeting the proposed 

ECEL over a sustained period of time 

would be feasible and measurable. 

EPA is also proposing to establish an 

ECEL action level of 0.00055 ppm as an 

8-hour TWA for TCE. Air concentrations 

at or above the action level would 

trigger more frequent periodic 

monitoring of exposures to TCE, as 

described in this unit. EPA is proposing 

to adopt the action level approach in 

implementing the TSCA ECEL, similar 

to the action level approach used by 

OSHA in the implementation of OSHA 

standards, although the values differ 

due to differing statutory authorities. As 

explained by OSHA, due to the variable 

nature of employee exposures, 

compliance with an action level 

provides employers with greater 

assurance that their employees will not 

be exposed to concentrations above the 

PELs (Ref. 44). EPA agrees with this 

reasoning and, like OSHA, expects the 

inclusion of an ECEL action level will 

stimulate innovation within industry to 

reduce exposures to levels below the 

action level. Therefore, EPA has 

identified a need for an action level for 

TCE and is proposing a level that would 

be half the 8-hour ECEL, which is in 

alignment with the precedented 

approach established under most OSHA 

standards. EPA is soliciting comment 

regarding an ECEL action level that is 

half the ECEL and any associated 

provisions related to the ECEL action 

level when the ECEL is significantly 

lower than the OSHA PEL. EPA is also 

soliciting comment on whether the 

ECEL action level should be aligned 

with OSHA PEL action levels (typically 

set at half the limit) due to the fact that 

PEL accounts for technological 

feasibility and the action level is not 

necessarily designed to be health 

protective. Since exposure below the 

ECEL would be health protective, EPA 

seeks comment on whether the action 

level should be set at a different value 

closer to the ECEL that would trigger 

increased monitoring to ensure that the 

ECEL is not exceeded, and whether 

technological feasibility should be 

considered in setting the action level. 

In summary, EPA is proposing that 

each owner or operator of a workplace 

subject to compliance with the TCE 

WCPP must ensure that no person is 

exposed to an airborne concentration of 

TCE in excess of 0.0011 ppm (0.0059 

mg/m3) as an 8-hour TWA (ECEL), with 

an action level identified as 0.00055 

ppm (0.0029 mg/m3) (ECEL action level) 

to the extent possible, as supported by 

documentation further described in Unit 

V.A.2.d.i.). For conditions of use for 

which the requirements to comply with 

the WCPP are being proposed, EPA 

expects that measurement of extremely 

low-ppm levels of TCE may present 

challenges to the regulated community. 

During the development of the TCE 

ECEL, EPA conducted a search to 

identify relevant NIOSH, OSHA, and 

EPA analytical methods that may be 

used to monitor for the presence of TCE 

in indoor air. While EPA identified 

analytical methods that may be used, 

based on information from stakeholders, 

EPA also recognizes that it may be 

difficult to operationalize routine use of 

these methods for detection at the low 

levels needed for the TCE ECEL and 

ECEL action level. Specifically, these 

methods may be challenging to use for 

personal breathing zone monitoring to 

detect lower air concentration levels at 

the ECEL and ECEL action level based 

on the developmental toxicity endpoint 

for fetal cardiac defects (Ref. 13). 

However, EPA acknowledges that in 

recent years commercial passive air 

sampling devices have improved and 

may be available for use for personal air 

sampling at extremely low-ppm levels 

of TCE (Ref. 45). EPA is requesting 

comment on personal air sampling 

devices that are capable of detecting 

indoor air TCE concentrations at or 

below the ECEL action level of 0.00055 

ppm (0.0029 mg/m3) with the requisite 

precision and accuracy. 

EPA acknowledges that the challenge 

of suitable personal breathing zone 

monitoring methods to detect TCE air 

concentration levels at the ECEL of 

0.0011 ppm and ECEL action level of 

0.00055 ppm could cause difficulty in 

determining whether a workplace is in 

compliance with the ECEL. EPA is 

therefore requesting comment on 

whether to require compliance with an 

interim exposure level based on the 

limit of detection of established 

analytical methods. This interim level, 

unlike the ECEL, would not necessarily 

eliminate unreasonable risk, but rather 

reduce risk to an extent that 

corresponds to the air concentration that 

current analytical methods can reliably 

measure to and would be the exposure 


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limit during the period in which TCE is 

still in use until its eventual 

prohibition. EPA requests comment on 

setting such an interim level for TCE 

based on a limit of detection that is the 

lowest limit of detection using 

analytical methods developed by 

OSHA/NIOSH for personal breathing 

zone monitoring. More specifically, EPA 

requests comment on using OSHA 

Method 1001, which has a personal 

breathing zone limit of detection for 

TCE of 18 ppb, or 0.018 ppm, to set an 

interim exposure limit of 0.036 ppm, 

with an action level of 0.018 ppm (Ref. 

46). 

Under this approach, EPA would 

initially establish an exposure value that 

would be technically feasible to detect 

in the near-term, with a step down to 

the ECEL at a later date, until the 

applicable prohibition would take 

effect. This approach would 

significantly reduce exposures to TCE 

from the current OSHA PEL of 100 ppm 

by establishing an interim exposure 

value of 0.036 ppm and action level of 

0.018 ppm, until advancements in 

technologies reliably support 

measurement at the ECEL or below. EPA 

requests comments that provide 

supported recommendations for one or 

more incremental exposure values and 

associated timelines for achieving the 

incremental exposure levels and the 

currently proposed ECEL of 0.0011 

ppm, and comments that consider and 

provide information on the needed 

advancements in exposure monitoring 

methods, analytical methods, and 

exposure controls, including expected 

timelines for developing these 

capabilities. 

The proposed requirements would be 

applicable to owners and operators of 

workplaces where manufacturing 

(including import), processing, and 

industrial and commercial use of TCE 

would be permitted to continue more 

than 1 year after the publication of the 

final rule. The proposed requirements 

would be applicable from the date of 

publication of the final rule until the 

prohibition compliance date for those 

conditions of use. However, the 

proposed requirements of the WCPP 

would not be applicable to owners and 

operators of workplaces where EPA is 

proposing to prohibit manufacturing 

and processing for certain industrial and 

commercial use and consumer uses 

within 1 year of the effective date of the 

final rule. The WCPP would also not be 

applicable to owners and operators of 

workplaces where EPA is proposing to 

prohibit distribution in commerce or 

disposal to industrial pre-treatment, 

industrial treatment, or publicly owned 

treatment works. 

As described further in Unit VI.A.1., 

EPA believes that long-term 

implementation of the WCPP for 

continued use of TCE is not a feasible 

means of addressing unreasonable risk 

such that prohibition ultimately would 

be necessary to address the 

unreasonable risk. 

ii. Monitoring Requirements 

Overview. Monitoring requirements 

are a key component of implementing 

EPA’s proposed WCPP. Initial 

monitoring for TCE would be critical for 

establishing a baseline of exposure for 

potentially exposed persons and for 

identifying the lowest achievable 

exposure level in a facility; similarly, 

periodic exposure monitoring would 

assure that exposures continue to be 

reduced to the lowest level achievable 

so that unreasonable risk of injury is 

reduced for potentially exposed persons 

in the workplace. Periodic exposure 

monitoring frequency could change if 

certain conditions are met, which are 

described in this unit. Additionally, in 

some cases, a change in workplace 

conditions with the potential to impact 

exposure levels would warrant 

additional monitoring, which is also 

described. To ensure compliance with 

monitoring activities, EPA proposes 

exposure monitoring recordkeeping 

requirements outlined in this unit. 

Initial exposure monitoring. Under 

the proposed regulation, each owner or 

operator of a workplace where any 

condition of use subject to a WCPP is 

occurring would be required to perform 

initial exposure monitoring to 

determine the extent of exposure of 

potentially exposed persons to TCE. 

Initial monitoring would notify owner 

or operators of the magnitude of 

possible exposures, to their potentially 

exposed persons with respect to their 

unique work conditions and 

environments. The results of the initial 

exposure monitoring would be used to 

help determine the lowest achievable 

level in a facility, the frequency of 

future periodic monitoring, whether 

additional exposure controls are 

necessary (such as engineering controls, 

administrative controls, and/or 

respiratory protection), and whether the 

owner or operator would need to 

demarcate a regulated area as described 

in this unit. 

EPA is proposing to require each 

owner or operator to establish an initial 

baseline monitoring sample to 

determine the magnitude of exposure 

for all persons who may be exposed to 

TCE within 180 days (6 months) after 

the date of publication of the final rule 

in the Federal Register. Where TCE is 

present in the workplace, each owner or 

operator would be required to determine 

each potentially exposed person’s 

exposure by either taking a personal 

breathing zone air sample of each 

potentially exposed person or taking 

personal breathing zone air samples that 

are representative of each potentially 

exposed person’s exposure performing 

the same or substantially similar 

operations in each work shift, in each 

job classification, and in each work area 

(hereinafter identified as an ‘‘exposure 

group’’). Representative 8-hour TWA 

exposures must be determined based on 

one or more samples representing fullshift exposures for each shift for each 

person in each job classification in each 

work area. Monitoring samples must be 

taken when and where the operating 

conditions are best representative of 

each potentially exposed person’s fullshift exposures, and also must represent 

the highest TCE exposures likely to 

occur under reasonably foreseeable 

conditions of use. EPA expects that 

owners and operators would attempt to 

monitor a baseline for all of the tasks 

during the same timeframe; however, 

EPA understands that certain tasks 

occur less frequently, and EPA is 

soliciting comments regarding the 

timing of the initial exposure 

monitoring so that it would be 

representative of all tasks involving TCE 

where exposures may approach the 

ECEL. If the owner or operator chooses 

a representative sample, such sampling 

must include persons that are the 

closest to the source of TCE, so that the 

monitoring results are representative of 

the most highly exposed persons in the 

workplace. EPA is also soliciting 

comments regarding use of area source 

monitoring instead of personal 

breathing zone as a representative 

sample of exposures. 

EPA also recognizes that some entities 

may already have exposure monitoring 

data. If the owner or operator has 

monitoring data conducted within five 

years prior to the effective date of the 

final rule and the monitoring would 

satisfy the monitoring requirements 

described in this unit, including the 

requirement that the data represent the 

highest TCE exposures likely to occur 

under reasonably foreseeable conditions 

of use, the owner or operator may rely 

on such earlier monitoring results for 

the initial baseline monitoring sample. 

EPA proposes to require each owner 

or operator to perform exposure 

monitoring to identify the lowest 

achievable exposure level in relation to 

the ECEL value, and ensure to the extent 

possible (supported by documentation 

further described in Unit V.A.2.d.i) that 

no person is exposed to an airborne 

concentration of TCE in exceedance of 


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the ECEL. EPA requests comment on 

how owners and operators should 

identify the lowest achievable exposure 

level, what documentation would be 

needed to support that further 

reductions are not possible, and 

whether EPA should provide a 

definition of meeting the ECEL to the 

extent possible. Additionally, EPA 

requests comment on whether current 

monitoring methods (Ref. 13) are able to 

detect airborne concentrations at the 

ECEL and action level values. EPA 

expects that detection and adherence to 

extremely low-ppm levels of TCE may 

present challenges to some in the 

regulated community; therefore, EPA is 

also requesting comment on whether 

EPA should propose specific 

requirements following results 

indicating non-detectable 

concentrations of TCE (non-detects), or 

a requirement that a specific monitoring 

method be used. 

Periodic exposure monitoring. EPA is 

proposing to require each owner or 

operator to conduct, for those exposure 

groups that exceed the following 

airborne concentration levels, the 

following periodic monitoring: 

• If all samples taken during the 

initial exposure monitoring reveal a 

concentration below the ECEL action 

level (0.00055 ppm 8-hour TWA), the 

owner or operator must repeat the 

periodic exposure monitoring at least 

once every five years. 

• If the initial or most recent 

exposure monitoring indicates that 

airborne exposure is above the ECEL 

(0.0011 ppm 8-hour TWA), the owner or 

operator must repeat the periodic 

exposure monitoring within 3 months of 

the most recent exposure monitoring. 

• If the most recent exposure 

monitoring indicates that airborne 

exposure is at or above the ECEL action 

level (0.00055 ppm 8-hour TWA) but at 

or below the ECEL (0.0011 ppm 8-hour 

TWA), the owner or operator must 

repeat the periodic exposure monitoring 

within 6 months of the most recent 

exposure monitoring. 

• If the most recent (non-initial) 

exposure monitoring indicates that 

airborne exposure is below the ECEL 

action level, the owners or operators 

must repeat such monitoring within 6 

months of the most recent monitoring 

until two consecutive monitoring 

measurements taken at least seven days 

apart, are below the ECEL action level 

(0.00055 ppm 8-hour TWA), at which 

time the owner or operator must repeat 

the periodic exposure monitoring at 

least once every 5 years. 

Additionally, in instances where an 

owner or operator does not 

manufacture, process, distribute, or use 

TCE for a condition of use for which the 

WCPP is proposed over the entirety of 

time since the last required periodic 

monitoring event, EPA is proposing that 

the owner or operator would be 

permitted to forgo the next periodic 

monitoring event. However, 

documentation of cessation of use of 

TCE would be required and periodic 

monitoring would be required to resume 

should the owner or operator restart any 

of the conditions of use listed in Unit 

V.A.2. for which the WCPP is proposed 

as a workplace protection measure. 

The proposed periodic monitoring 

requirements are also outlined in Table 

1. EPA requests comment on the 

timeframes for periodic monitoring 

outlined in this unit. EPA may finalize 

significantly shorter or longer 

compliance timeframes based on 

consideration of public comments. EPA 

requests comment on the ability for a 

facility to perform the proposed 

periodic monitoring requirements, 

specifically whether monitoring 

methods can detect the ECEL action 

level and ECEL value. 

TABLE 1—PERIODIC MONITORING REQUIREMENTS

Air concentration condition Periodic monitoring requirement 

If all initial exposure monitoring is below the ECEL action level 

(<0.00055 ppm 8-hour TWA).

Periodic exposure monitoring is required at least once every 5 years. 

If the initial or most recent exposure monitoring indicates that airborne 

exposure is above the ECEL (>0.0011 ppm 8-hour TWA).

Periodic exposure monitoring is required within 3 months of the most 

recent exposure monitoring. 

If the initial or most recent exposure monitoring indicates that airborne 

exposure is at or above the ECEL action level but at or below the 

ECEL (≥0.55 ppb 8-hour TWA, ≤0.0011 ppm 8-hour TWA).

Periodic exposure monitoring is required within 6 months of the most 

recent exposure monitoring. 

If the two most recent (non-initial) exposure monitoring measurements, 

taken at least seven days apart within a 6-month period, indicate that 

airborne exposure is below the ECEL action level (<0.00055 ppm 8- 

hour TWA).

Periodic exposure monitoring is required within 5 years of the most recent exposure monitoring. 

If the owner or operator engages in a condition of use for which compliance with the WCPP would be required but does not manufacture, 

process, use, or dispose of TCE in that condition of use over the entirety of time since the last required monitoring event.

The owner or operator may forgo its current periodic monitoring event. 

However, documentation of cessation of use of TCE as well as periodic monitoring would be required when the owner or operator resumes or starts any of the conditions of use for which compliance 

with the WCPP is proposed. 

Additional exposure monitoring. In 

addition to the initial and periodic 

exposure monitoring, EPA is proposing 

that each owner or operator conduct 

additional exposure monitoring 

whenever a change in the production, 

process, control equipment, personnel, 

or work practices that may reasonably 

be expected to result in new or 

additional exposures at or above the 

ECEL action level, or when the owner or 

operator has any reason to believe that 

new or additional exposures at or above 

the ECEL action level have occurred. In 

the event of start-up, shutdown, spills, 

leaks, ruptures or other breakdowns that 

may lead to employee exposure, EPA is 

proposing that each owner or operator 

must conduct additional initial 

exposure monitoring to potentially 

exposed persons (using personal 

breathing zone sampling) after the 

cleanup of the spill or repair of the leak, 

rupture or other breakdown. An 

additional exposure monitoring event 

may result in an increased frequency of 

periodic monitoring. For example, if the 

initial monitoring results from a 

workplace are above the ECEL action 

level, but below the ECEL, periodic 

monitoring is required every 6 months. 

If additional monitoring is performed 

because increased exposures are 

suspected, and the results are above the 

ECEL, subsequent periodic monitoring 

would have to be performed every 3 

months. The required additional 

exposure monitoring should not delay 

implementation of any necessary 

cleanup or other remedial action to 

reduce the exposures to persons in the 

workplace. 


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Other monitoring requirements. For 

each monitoring event, EPA is 

proposing to require owners or 

operators ensure that their methods be 

accurate, to a confidence level of 95 

percent, to within plus or minus 25 

percent for airborne concentrations of 

TCE. Also, EPA is proposing to require 

use of appropriate sampling and 

analytical methods used to determine 

TCE exposure, including as relevant: (A) 

Use of an analytical method already 

approved by EPA, OSHA or NIOSH, or 

another analytical method that has been 

demonstrated to meet the proposed 

accuracy requirement at an appropriate 

limit of detection for the ECEL and 

ECEL action level; (B) Compliance with 

the Good Laboratory Practice Standards 

at 40 CFR part 792. Additionally, EPA 

is proposing to require owners and 

operators to re-monitor within 15 

working days after receipt of the results 

of any exposure monitoring when 

results indicate non-detect or air 

monitoring equipment malfunction, 

unless an Environmental Professional as 

defined at 40 CFR 312.10 or a Certified 

Industrial Hygienist reviews the 

monitoring results and determines remonitoring is not necessary. 

EPA is also proposing to require that 

each owner or operator maintain 

exposure monitoring records that 

include the following information for 

each monitoring event: 

(A) Dates, duration, and results of 

each sample taken; 

(B) All measurements that may be 

necessary to determine the conditions 

(e.g., work site temperatures, humidity, 

ventilation rates, monitoring equipment 

type and calibration dates) that may 

affect the monitoring results; 

(C) Name, workplace address, work 

shift, job classification, and work area of 

the person monitored; documentation of 

all potentially exposed persons whose 

exposures the monitoring is intended to 

represent if using a representative 

sample; and type of respiratory 

protective device worn by the 

monitored person, if any; 

(D) Use of appropriate sampling and 

analytical methods, such as analytical 

methods already approved by EPA, 

OSHA or NIOSH, or compliance with an 

analytical method verification 

procedure; 

(E) Compliance with the Good 

Laboratory Practice Standards at 40 CFR 

part 792; and 

(F) Information regarding air 

monitoring equipment, including: type, 

maintenance, calibrations, performance 

tests, limits of detection, and any 

malfunctions. 

iii. Incorporation of the Hierarchy of 

Controls 

EPA is proposing to require owners or 

operators to implement the WCPP in 

accordance with the hierarchy of 

controls and encourages the use of 

pollution prevention to control 

exposures whenever practicable. 

Pollution prevention, also known as 

source reduction, is any practice that 

reduces, eliminates, or prevents 

pollution at its source (e.g., elimination 

and substitution). Similarly, the 

hierarchy of controls includes, in order 

of preference, elimination, substitution, 

engineering controls, and administrative 

controls, prior to relying on PPE as a 

means of controlling exposures (Ref. 

12). EPA is proposing to require owners 

or operators to reduce inhalation 

exposures below the ECEL in 

accordance with the hierarchy of 

controls to the extent possible as 

supported by documentation further 

described in Unit V.A.2.d.i.). EPA 

expects that, for conditions of use for 

which EPA is proposing a WCPP as a 

protection measure, compliance at most 

workplaces would be part of an existing 

industrial hygiene program. Workplaces 

would have to institute one or a 

combination of elimination, 

substitution, engineering controls, or 

administrative controls to reduce 

exposures to the extent feasible (Ref. 

12). If an owner or operator chooses to 

replace TCE with a substitute, EPA 

recommends that they carefully review 

the available hazard and exposure 

information on the potential substitutes 

to avoid a regrettable substitution. 

If an effort to identify and implement 

feasible exposure controls, in 

accordance with the hierarchy of 

controls, such as elimination, 

substitution, engineering controls, and 

administrative controls is found not to 

be sufficient to reduce exposures to or 

below the ECEL for all persons in the 

workplace, EPA proposes to require 

each owner or operator to use such 

controls to reduce TCE concentrations 

in the workplace to the lowest levels 

achievable and, only after levels cannot 

be further reduced, supplement these 

controls using respiratory protection 

before persons are permitted to enter a 

regulated area, as described in this unit. 

In such cases, EPA would require that 

the owner or operator provide those 

persons exposed or who may be 

exposed to TCE by inhalation above the 

ECEL with respirators so that exposures 

can be reduced to the extent possible 

(supported by documentation further 

described in Unit V.A.2.d.i.). EPA also 

proposes to require that each owner or 

operator document their evaluation of 

elimination, substitution, engineering 

and administrative exposure control 

strategies and, if applicable, the reasons 

why they found these strategies 

infeasible to control exposures below 

the ECEL, in an exposure control plan 

as described in this unit. In addition, a 

regulated entity would be prohibited 

from rotating work schedules of 

potentially exposed persons to comply 

with the ECEL 8-hour TWA. EPA may 

require more, less, or different 

documentation regarding exposure 

control strategies in the final rule based 

on consideration of public comments. 

The Agency understands that certain 

engineering controls can reduce 

exposures to people inside the 

workplace but may lead to increased 

ventilation of TCE outside of the 

workplace, thereby potentially 

increasing risks of adverse health effects 

from exposures to TCE in ambient air to 

people in fenceline communities. EPA 

expects that processing and commercial 

use of TCE for the conditions of use for 

which the WCPP would apply will 

decrease ahead of the prohibition 

compliance dates (Ref. 3) and therefore 

expects that any risks to fenceline 

communities would also decrease. More 

information on EPA’s analysis of 

ambient air and water pathways is in 

Unit VII.A. To understand more fully 

the potential impacts to fenceline 

communities of requirements to reduce 

workplace exposure to TCE, EPA is 

requesting comment on whether 

industry anticipates increased releases 

of TCE to outdoor air associated with 

the implementation of the WCPP. In 

order to avoid unintended increases in 

exposures to people from TCE emissions 

to ambient air, EPA requests comment 

on whether owners and operators 

should be required to attest in their 

exposure control plan that engineering 

controls selected do not increase 

emissions of TCE to ambient air outside 

of the workplace and document in their 

exposure control plan whether 

additional equipment was installed to 

capture emissions of TCE to ambient air. 

EPA requests comment on how such a 

requirement could impact the 

availability, feasibility, or cost of 

engineering controls as a means to 

reduce workplace exposures to or below 

the proposed ECEL. 

iv. Regulated Area 

Based on the exposure monitoring, 

EPA is proposing to require that owners 

or operators of workplaces subject to a 

WCPP as a protection measure 

demarcate any area where airborne 

concentrations of TCE exceed or are 

reasonably expected to exceed the 

ECEL. Regulated areas would be 


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demarcated using administrative 

controls, such as warning signs or 

highly visible signifiers, in multiple 

languages as appropriate (e.g., based on 

languages spoken by potentially 

exposed persons), placed in 

conspicuous areas, and documented 

through training and recordkeeping. The 

owner or operator would be required to 

restrict access to the regulated area from 

anyone who is not an authorized user, 

which includes any potentially exposed 

person that lacks proper training, is not 

wearing required PPE as described in 

this unit or is otherwise unauthorized to 

enter. EPA is proposing to require 

owners and operators demarcate a 

regulated area, beginning 9 months after 

the date of publication of the final rule, 

or within 3 months after receipt of any 

exposure monitoring that indicates 

exposures exceeding the ECEL. EPA is 

soliciting comment on requiring 

warning signs to demarcate regulated 

areas, such as the requirements found in 

OSHA’s General Industry Standard for 

Beryllium (29 CFR 1910.1024(m)(2)). 

EPA is also requesting comment on 

whether the owner or operator should 

be required to permit designated 

representatives of employees and other 

workers to enter regulated areas to 

observe exposure monitoring similar to 

typical OSHA Standard requirements, 

e.g., 29 CFR 1910.1024(d)(7). 

v. Notification of Monitoring Results 

EPA proposes that the owner or 

operator must, within 15 working days 

after receipt of the results of any 

exposure monitoring, notify each person 

whose exposure is represented by that 

monitoring in writing, either 

individually to each potentially exposed 

person or by posting the information in 

an appropriate and accessible location, 

such as public spaces or common areas, 

outside the regulated area. This notice 

must include the exposure monitoring 

results, identification and explanation 

of the ECEL and ECEL action level in 

plain language, identification of the 

lowest achievable exposure level, if 

applicable, any corresponding required 

respiratory protection, if applicable, the 

quantity, location, manner of TCE use 

and identified releases of TCE that 

could result in exposure to TCE, and 

whether the airborne concentration of 

TCE exceeds the ECEL. The notice must 

also include a description of actions 

taken by the owner or operator to reduce 

inhalation exposures to or below the 

ECEL, if applicable, or refer to a 

document available to the potentially 

exposed persons which states the 

actions to be taken to reduce exposures. 

The notice would be required to be 

posted in multiple languages if 

necessary (e.g., notice must be in a 

language that the potentially exposed 

person understands, including a nonEnglish language version representing 

the language of the largest group of 

workers who cannot readily 

comprehend or read English). 

c. Personal Protective Equipment (PPE) 

Program 

Where elimination, substitution, 

engineering controls, and administrative 

controls are not feasible to reduce the 

air concentration to or below the ECEL 

for all potentially exposed persons, EPA 

is proposing to require implementation 

of a PPE program in alignment with 

OSHA’s General Requirements for 

Personal Protective Equipment at 29 

CFR 1910.132. Consistent with 29 CFR 

1910.132, owners and operators would 

be required to provide PPE, including 

respiratory protection and dermal 

protection selected in accordance with 

the guidelines described in this unit, 

that is of safe design and construction 

for the work to be performed. EPA is 

proposing to require owners and 

operators ensure each potentially 

exposed person who is required by this 

unit to wear PPE to use and maintain 

PPE in a sanitary, reliable, and 

undamaged condition. Owners and 

operators would be required to select 

and provide PPE that properly fits each 

potentially exposed person who is 

required by this unit to use PPE and 

communicate PPE selections to each 

affected person. 

As part of the PPE program, EPA is 

also proposing that owners and 

operators must comply with OSHA’s 

general PPE training requirements at 29 

CFR 1910.132(f) for application of a PPE 

training program, including providing 

training on proper use of PPE (e.g., 

when and where PPE is necessary, 

proper application, wear, and removal 

of PPE, maintenance, useful life, and 

disposal of PPE). EPA is proposing that 

owners and operators would provide 

PPE training to each potentially exposed 

person who is required by this unit to 

wear PPE prior to or at the time of initial 

assignment to a job involving potential 

exposure to TCE. Owners and operators 

would also have to re-train each affected 

person at least once annually or 

whenever the owner or operator has 

reason to believe that a previously 

trained person does not have the 

required understanding and skill to 

properly use PPE, or when changes in 

the workplace or in the PPE to be used 

render the previous training obsolete. 

This unit includes a description of the 

PPE Program, including proposed PPE 

as it relates to respiratory protection, 

proposed PPE as it relates to dermal 

protection, and other proposed 

requirements such as additional training 

for respirators and recordkeeping to 

support implementation of a PPE 

program. 

i. Respiratory Protection 

Where elimination, substitution, 

engineering and administrative controls 

are not feasible to reduce the air 

concentration to or below the ECEL, 

EPA proposes to set minimum 

respiratory PPE requirements based on 

an entity’s most recent measured air 

concentration and the level of PPE that 

EPA determined would be needed to 

reduce exposure to the ECEL. In those 

circumstances, EPA is proposing to 

require a respiratory protection PPE 

program with worksite-specific 

procedures and elements for required 

respirator use. The respiratory 

protection PPE program proposed by 

EPA would be based on the most recent 

exposure monitoring concentration 

measured as an 8-hour TWA and would 

be administered by a suitably trained 

program administrator. EPA is also 

proposing to require each owner or 

operator select respiratory protection in 

accordance with the guidelines 

described in this unit and 29 CFR 

1910.134(a) through (l), except 

(d)(1)(iii), for proper respirator use, 

maintenance, fit-testing, medical 

evaluation, and training. EPA is not 

proposing to cross reference 29 CFR 

1910.134(d)(1)(iii) because the WCPP 

contains requirements for identifying 

TCE respiratory hazards in the 

workplace. 

Required Respiratory Protection. EPA 

is proposing to require each owner or 

operator supply a respirator, selected in 

accordance with this unit, to each 

person who enters a regulated area 

within 3 months after the receipt of any 

exposure monitoring that indicates 

exposures exceeding the ECEL and 

thereafter must ensure that all persons 

within the regulated area are using the 

provided respirators whenever TCE 

exposures exceed or can reasonably be 

expected to exceed the ECEL. Given the 

risks associated with TCE exposure 

above the ECEL, prompt compliance 

with the respiratory protection 

requirements is important, but EPA 

expects that most owners or operators 

will need some time after the exposure 

monitoring results are received to 

acquire the correct respirators and 

establish a respiratory protection 

program, including training, fit-testing, 

and medical evaluations. While EPA 

believes that 3 months should be 

sufficient for this purpose, EPA is 

seeking comment on whether this 

timeframe should be shorter (e.g., 


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within two weeks after the receipt of 

any exposure monitoring that indicates 

exposure exceeding the ECEL), given the 

severity of the effect. EPA is also 

proposing that owners or operators who 

would be required to administer a 

respiratory protection program must 

supply a respirator selected in 

accordance with 29 CFR 1910.134(d)(1) 

(except (d)(1)(iii)). Additionally, EPA is 

proposing that the owner or operator 

must ensure that all filters, cartridges, 

and canisters used in the workplace are 

labeled and color coded with the NIOSH 

approval label and that the label is not 

removed and remains legible. 29 CFR 

1910.134(d)(3)(iii), which EPA is 

proposing to cross-reference, requires 

either the use of respirators with an endof-life service indicator certified by 

NIOSH for the contaminant, in this case 

TCE, or implementation of a change 

schedule for canisters and cartridges 

that ensures that they are changed 

before the end of their service life. EPA 

is requesting comment on whether there 

should be a requirement to replace 

cartridges or canisters after a certain 

number of hours, such as the 

requirements found in OSHA’s General 

Industry Standard for 1,3-Butadiene (29 

CFR 1910.1051(h)), or a requirement for 

a minimum service life of non-powered 

air-purifying respirators such as the 

requirements found in OSHA’s General 

Industry Standard for Benzene (29 CFR 

1910.1028(g)(3)(D)). 

EPA is proposing the following 

requirements for respiratory protection, 

based on the exposure monitoring 

concentrations measured as an 8-hour 

TWA that exceed the ECEL (0.0011 

ppm). EPA is proposing to establish 

minimum respiratory protection 

requirements, such that any respirator 

affording a higher degree of protection 

than the following proposed 

requirements may be used. This unit 

includes respirator selection 

requirements for respirators of assigned 

protection factors (APFs) of 1,000 or 

greater. 

• If the measured exposure 

concentration is at or below 0.0011 ppm 

(1.1 ppb): no respiratory protection is 

required. 

• If the measured exposure 

concentration is above 0.0011 ppm (1.1 

ppb) and less than or equal to 0.0055 

ppm (5.5 ppb) (5 times ECEL): Any 

NIOSH-certified air-purifying quarter 

mask respirator (APF 5). 

• If the measured exposure 

concentration is above 0. 0055 ppm (5.5 

ppb) and less than or equal to 0.011 

ppm (11.0 ppb) (10 times ECEL): Any 

NIOSH-certified air-purifying half mask 

or full facepiece respirator equipped 

with NIOSH-approved organic vapor 

cartridges or canisters; or any negative 

pressure (demand mode) supplied air 

respirator equipped with a half mask 

(APF 10). 

• If the measured exposure 

concentration is above 0.0011 ppm (1.1 

ppb) and less than or equal to 0.0275 

ppm (27.5 ppb) (25 times ECEL): Any 

NIOSH-certified air-purifying full 

facepiece respirator equipped with 

NIOSH-approved organic vapor 

cartridges or canisters; any NIOSHcertified powered air-purifying 

respirator equipped with NIOSHapproved organic vapor cartridges; or 

any NIOSH-certified continuous flow 

supplied air respirator equipped with a 

hood or helmet (APF 25). 

• If the measured exposure 

concentration is above 0.0275 ppm (27.5 

ppb and less than or equal to 0.055 ppm 

(55.0 ppb) (50 times ECEL): Any NIOSHcertified air-purifying full facepiece 

respirator equipped with NIOSHapproved organic vapor cartridges or 

canisters; any NIOSH-certified powered 

air-purifying respirator equipped with a 

tight-fitting half facepiece and NIOSHapproved organic vapor cartridges or 

canisters; any NIOSH-certified negative 

pressure (demand mode) supplied-air 

respirator equipped with a full 

facepiece; any NIOSH-certified 

continuous flow supplied-air respirator 

equipped with a tight-fitting half 

facepiece; any NIOSH-certified 

pressure-demand or other positive 

pressure mode supplied-air respirator 

equipped with a tight-fitting half 

facepiece; or any NIOSH-certified 

negative pressure (demand mode) selfcontained breathing apparatus respirator 

equipped with a full facepiece (APF 50). 

• If the measured exposure 

concentration is above 0.055 ppm (55.0 

ppb) and less than or equal to 1.1 ppm 

(1,100 ppb) (1,000 times ECEL): Any 

NIOSH-certified powered air-purifying 

respirator equipped with a full facepiece 

and NIOSH-approved organic vapor 

cartridges or canisters; or any NIOSHcertified supplied air respirator 

equipped with a full facepiece and 

operated in a continuous flow mode or 

pressure demand or other positive 

pressure mode (APF 1,000). 

• If the measured exposure 

concentration is greater than 1.1 ppm 

(1,100 ppb) (1,000 times ECEL) or the 

concentration is unknown: Any NIOSHcertified self-contained breathing 

apparatus (SCBA) equipped with a full 

facepiece and operated in a pressure 

demand or other positive pressure 

mode; or any NIOSH-certified supplied 

air respirator equipped with a full 

facepiece and operated in a pressure 

demand or other positive pressure mode 

in combination with an auxiliary SCBA 

operated in a pressure demand or other 

positive pressure mode (APF 10,000). 

EPA proposes to require that owners 

and operators document respiratory 

protection used and PPE program 

implementation. EPA proposes to 

require that owners and operators 

document in the exposure control plan 

or other documentation of the facility’s 

safety and health program information 

relevant to respiratory program, 

including records on the name, 

workplace address, work shift, job 

classification, work area, and type of 

respirator worn (if any) by each 

potentially exposed person, 

maintenance, and fit-testing, as 

described in 29 CFR 1910.134(f), and 

training in accordance with 29 CFR 

1910.132(f) and 29 CFR 1910.134(k). 

ii. Dermal Protection 

EPA is proposing to require use and 

provision of chemically resistant gloves 

by potentially exposed persons in 

combination with specific activity 

training (e.g., glove selection (type, 

material), expected duration of glove 

effectiveness, actions to take when glove 

integrity is compromised, storage 

requirements, procedure for glove 

removal and disposal, chemical 

hazards) for tasks where dermal 

exposure can be expected to occur. EPA 

is proposing that owners and operators 

must also consider other glove factors, 

such as compatibility of multiple 

chemicals used simultaneously while 

wearing TCE-resistant gloves or with 

glove liners, permeation, degree of 

dexterity required to perform a task, and 

temperature, as identified in the Hand 

Protection section of OSHA’s Personal 

Protection Equipment Guidance (Ref. 

47), when selecting appropriate PPE. 

Furthermore, owners and operators can 

select gloves that have been tested in 

accordance with the American Society 

for Testing Material (ASTM) F739 

‘‘Standard Test Method for Permeation 

of Liquids and Gases through Protective 

Clothing Materials under Conditions of 

Continuous Contact.’’ EPA requests 

comment on the degree to which 

additional guidance related to use of 

gloves might be necessary. Additionally, 

EPA requests comment on whether EPA 

should incorporate additional dermal 

protection requirements into the 

exposure control plan or require 

consideration of the hierarchy of 

controls for dermal exposures. 

d. General WCPP Requirements 

i. Exposure Control Plan 

EPA proposes to require that owners 

and operators document their exposure 

control strategy and implementation in 


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an exposure control plan or through 

adding EPA-required information to any 

existing documentation of the facility’s 

safety and health program developed as 

part of meeting OSHA requirements or 

other safety and health standards. EPA 

proposes to require that each owner or 

operator document in the exposure 

control plan the following: 

(A) Identification and rationale of 

exposure controls used or not used in 

the following sequence: elimination of 

TCE, substitution of TCE, engineering 

controls, and administrative controls to 

reduce exposures in the workplace to 

either at or below the ECEL or to the 

lowest level achievable for TCE in the 

workplace; 

(B) The exposure controls selected 

based on feasibility, effectiveness, and 

other relevant considerations; 

(C) If exposure controls were not 

selected, document the efforts 

identifying why these are not feasible, 

not effective, or otherwise not 

implemented; 

(D) Actions taken to implement 

exposure controls selected, including 

proper installation, maintenance, 

training or other steps taken; 

(E) Description of any regulated area 

and how it is demarcated, and 

identification of authorized persons; 

and description of when the owner or 

operator expects exposures may be 

likely to exceed the ECEL or lowest 

achievable exposure level; 

(F) Identification of the lowest 

achievable exposure level and why 

further reductions are not possible; 

(G) Regular inspections, evaluations, 

and updating of the exposure controls to 

ensure effectiveness and confirmation 

that all persons are implementing them 

as required; 

(H) Occurrence and duration of any 

start-up, shutdown, or malfunction of 

the facility that causes air 

concentrations to be above the ECEL or 

lowest achievable exposure level and 

subsequent corrective actions taken 

during start-up, shutdown, or 

malfunctions to mitigate exposures to 

TCE; and 

(I) Availability of the exposure control 

plan and associated records for 

potentially exposed persons. 

ii. Workplace Information and Training 

EPA is also proposing to require 

implementation of a training program in 

alignment with the OSHA Hazard 

Communication Standard (29 CFR 

1910.1200) and the OSHA General 

Industry Standard for Methylene 

Chloride (29 CFR 1910.1052). To ensure 

that potentially exposed persons in the 

workplace are informed of the hazards 

associated with TCE exposure, EPA is 

proposing to require that owners or 

operators of workplaces subject to the 

WCPP institute a training and 

information program for potentially 

exposed persons and assure their 

participation in the training and 

information program. 

As part of the training and 

information program, the owner or 

operator would be required to provide 

information and comprehensive training 

in an understandable manner (i.e., plain 

language) and in multiple language as 

appropriate (e.g., based on languages 

spoken by potentially exposed persons) 

to potentially exposed persons prior to 

or at the time of initial assignment to a 

job involving potential exposure to TCE. 

In alignment with the OSHA Hazard 

Communication Standard, owners and 

operators would be required to provide 

information and training to all 

potentially exposed persons that 

includes (A) the requirements of the 

TCE WCPP and how to access or obtain 

a copy of the requirements of the WCPP; 

(B) the quantity, location, manner of 

use, release, and storage of TCE and the 

specific operations in the workplace 

that could result in TCE exposure; (C) 

principles of safe use and handling of 

TCE in the workplace, including 

specific measures the owner or operator 

has implemented to reduce inhalation 

exposures or prevent dermal contact 

with TCE, such as work practices and 

PPE used; (D) the methods and 

observations that may be used to detect 

the presence or release of TCE in the 

workplace (such as monitoring 

conducted by the owner or operator, 

continuous monitoring devices, visual 

appearance or odor of TCE when being 

released, etc.); and (E) the health 

hazards associated with exposure to 

TCE. 

In addition to providing training at 

the time of initial assignment to a job 

involving potential exposure to TCE, 

and in alignment with the OSHA 

General Industry Standard for Beryllium 

(20 CFR 1910.1024), owners and 

operators subject to the TCE WCPP 

would be required to re-train each 

potentially exposed person annually to 

ensure they understand the principles of 

safe use and handling of TCE in the 

workplace. Owners and operators would 

also need to update the training as 

necessary whenever there are changes in 

the workplace, such as new tasks or 

modifications of tasks, in particular, 

whenever there are changes in the 

workplace that increase exposure to 

TCE or where potentially exposed 

persons’ exposure to TCE can 

reasonably be expected to exceed the 

action level. To support compliance, 

EPA is proposing that each owner or 

operator of a workplace subject to the 

WCPP would be required to provide to 

the EPA, upon request, all available 

materials related to workplace 

information and training. 

iii. Workplace Participation 

EPA encourages owners or operators 

to consult with persons that have 

potential for exposure on the 

development and implementation of 

exposure control plans and PPE/ 

respirator programs. EPA is proposing to 

require owners or operators to provide 

potentially exposed persons or their 

designated representatives regular 

access to the exposure control plans, 

exposure monitoring records, and PPE 

program implementation and 

documentation. To ensure compliance 

in workplace participation, EPA is 

proposing that the owner or operator 

document the notice to and ability of 

any potentially exposed person that may 

reasonably be affected by TCE 

inhalation exposure or dermal contact 

with TCE to readily access the exposure 

control plans, facility exposure 

monitoring records, PPE program 

implementation, or any other 

information relevant to TCE inhalation 

or dermal exposure in the workplace. 

EPA is requesting comment on how 

owners and operators can engage with 

potentially exposed persons on the 

development and implementation of an 

exposure control plan and PPE program. 

iv. Recordkeeping 

To support and demonstrate 

compliance, EPA is proposing that each 

owner or operator of a workplace 

subject to WCPP retain compliance 

records for five years. EPA is proposing 

to require records to include: 

(A) the exposure control plan; 

(B) PPE program implementation and 

documentation, including as necessary, 

respiratory protection and dermal 

protection used and related PPE 

training; and 

(C) information and training provided 

to each person prior to or at the time of 

initial assignment and any re-training. 

In addition, EPA is proposing that 

owners and operators subject to the 

WCPP requirements maintain records to 

include: 

(D) The exposure monitoring records; 

(E) Notification of exposure 

monitoring results; and 

(F) To the extent that the owner or 

operator relies on prior exposure 

monitoring data, records that 

demonstrates that it meets all of the 

proposed WCPP requirements. 

The owners and operators, upon 

request by EPA, would be required to 

make all records that are maintained as 


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described in this unit available to EPA 

for examination and copying in 

accordance with EPA requirements. All 

records required to be maintained by 

this unit could be kept in the most 

administratively convenient form 

(electronic or paper). 

v. Compliance Timeframes 

EPA is proposing to require each 

owner or operator of a workplace 

subject to an ECEL conduct initial 

baseline monitoring according to the 

process outlined in this unit by 6 

months after date of publication of the 

final rule in the Federal Register. EPA 

is proposing to require each owner or 

operator ensure that the airborne 

concentration of TCE does not exceed 

the ECEL or lowest achievable exposure 

level for all potentially exposed persons 

within 9 months after the date of 

publication of the final rule in the 

Federal Register, and if applicable, each 

owner or operator must provide 

respiratory protection sufficient to 

reduce inhalation exposures to below 

the ECEL to all potentially exposed 

persons in the regulated area within 3 

months after receipt of the results of any 

exposure monitoring that indicates 

exposures exceeding the ECEL or, if 

using monitoring data conducted within 

five years prior to the effective date of 

the final rule that satisfies all other 

requirements of the proposed WCPP, 

within 9 months after the date of 

publication of the final rule in the 

Federal Register. EPA is also proposing 

to require owners and operators 

demarcate a regulated area within 3 

months after receipt of any exposure 

monitoring that indicates exposures 

exceeding the ECEL. Regulated entities 

should then proceed accordingly to 

implement an exposure control plan 

within 12 months after date of 

publication of the final rule in the 

Federal Register. EPA requests 

comment relative to the ability of 

owners or operators to conduct initial 

monitoring within 6 months after date 

of publication of the final rule in the 

Federal Register, and anticipated 

timeframes for any procedural 

adjustments (i.e., use of new 

technologies for personal breathing zone 

monitoring at extremely low-ppm levels 

of TCE) needed to comply with the 

requirements outlined in this unit, 

including establishment of a respiratory 

protection program and development of 

an exposure control plan. 

EPA understands that the regulated 

community may have difficulty 

measuring at or below the ECEL 

consistently over an entire work shift. 

Therefore, EPA is requesting comment 

regarding the amount of time, if any, it 

would take the regulated community to 

develop a method to measure at or 

below the ECEL over an entire work 

shift. EPA is interested in what levels of 

detection are possible based on existing 

monitoring methods, justification for the 

timeframe of the specific steps needed 

to develop a more sensitive monitoring 

method, and any additional detailed 

information related to establishing a 

monitoring program to reliably measure 

TCE at or below the ECEL. 

With regard to the compliance 

timeframe for those occupational 

conditions of use which are subject to 

dermal protection requirements, EPA is 

proposing to require each owner or 

operator of a workplace subject to 

dermal protection requirements to 

establish dermal protection outlined in 

this unit by 6 months after publication 

of the final rule in the Federal Register. 

EPA requests comment relative to the 

ability of owners or operators to 

implement dermal protection within 6 

months of publication of the final rule 

in the Federal Register, and anticipated 

timeframes for any procedural 

adjustments needed to comply with the 

requirements outlined in this unit. EPA 

may finalize shorter or longer 

compliance timeframes based on 

consideration of public comments. 

3. TSCA Section 6(g) Exemptions 

Under TSCA section 6(g)(1), EPA may 

grant an exemption from a requirement 

of a TSCA section 6(a) rule for a specific 

condition of use of a chemical substance 

or mixture if the Agency makes one of 

three findings. TSCA section 6(g)(1)(A) 

permits such an exemption if the 

specific condition of use is a critical or 

essential use for which no technically 

and economically feasible safer 

alternative is available. Under TSCA 

section 6(g)(1)(B), EPA must find that 

compliance with the requirement would 

significantly disrupt the national 

economy, national security, or critical 

infrastructure to provide an exemption. 

Finally, TSCA section 6(g)(1)(C) allows 

for an exemption based on an EPA 

finding that the specific condition of use 

of the chemical substance or mixture, as 

compared to reasonably available 

alternatives, provides a substantial 

benefit to health, the environment, or 

public safety. Based on discussions and 

information provided by industry 

stakeholders and consultation with DOD 

and NASA, EPA has analyzed the need 

for several different exemptions and is 

proposing to grant six. This unit 

presents the results of that analysis. 

Pursuant to TSCA section 6(g)(3), if an 

exemption is finalized, EPA may by rule 

later extend, modify, or eliminate the 

exemption, on the basis of reasonably 

available information and after adequate 

public justification, if EPA determines 

the exemption warrants a change. EPA 

will initiate this rulemaking process at 

the request of any regulated entity 

benefiting from such an exemption. The 

Agency is open to engagement 

throughout the duration of any TSCA 

section 6(g) exemption and emphasizes 

that, to ensure continuity in the event of 

an extension or modification, such a 

request should come at least two years 

prior to the expiration of an exemption. 

a. Analysis of the Need for TSCA 

Section 6(g)(1) Exemptions for Uses of 

TCE That Are Critical or Essential 

i. Analysis of the Need for a TSCA 

Section 6(G)(1)(B) Exemption for 

Industrial and Commercial Use of TCE 

as a Processing Aid for Battery Separator 

Manufacturing (Lead-Acid And Lithium 

Battery Separators) 

As part of industry stakeholder 

engagement and interagency 

consultation with other Federal agencies 

following publication of the 2020 Risk 

Evaluation for TCE (Ref. 35 stakeholder 

meeting list), EPA was made aware that 

some U.S. battery separator 

manufacturers continue to rely on TCE 

to manufacture specialty separator 

materials of lead-acid and lithium 

batteries (Refs. 48, 49). In the 2020 Risk 

Evaluation for TCE, EPA evaluated the 

industrial and commercial use of TCE as 

a processing aid for battery separator 

manufacturing. EPA understands that 

the manufacture of battery separators 

takes place separately from overall 

battery manufacture, that both lead-acid 

and lithium batteries require separators 

for operation, and that the lead-acid and 

lithium battery separator manufacturing 

processes are highly engineered 

specialty products manufactured with 

precision to stringent technical 

specifications essential to power 

vehicles and systems in the U.S. supply 

chain for multiple critical infrastructure 

sectors within the national economy. 

EPA understands that separators are 

fundamental components in batteries 

that provide the necessary separation 

between the internal anode and cathode 

components that make batteries work, 

and that a restriction on TCE use for the 

production of battery separators would 

critically impact the U.S. battery 

manufacturing supply chain and 

impede the expansion of domestic 

battery production capacity (Refs. 50, 

51). Industry stakeholders as well as 

other Federal agencies have discussed 

with EPA the potential adverse 

implications of banning or severely 

restricting use of TCE for battery 

separator production, as it would 


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disrupt the supply chain and leave the 

U.S. reliant on foreign suppliers to the 

extent that they are available to support 

the national economy, national security, 

and critical infrastructure (Refs. 48, 49). 

EPA agrees these assertions have merit. 

Lead-acid and lithium batteries are 

essential to serve critical infrastructure 

such as transportation systems, security 

systems, as well as to energize the 

national defense base (e.g., nuclear 

submarine batteries). Two companies 

requested that EPA provide exemptions 

under TSCA section 6(g) to allow for the 

continued use of TCE in the 

manufacture of battery separators, 

noting their significant concern about 

potential prohibitions under TSCA on 

the use of TCE. Both companies 

emphasized the need for the continued 

use of TCE in the manufacture of battery 

separators to strengthen critical supply 

chains by revitalizing domestic 

manufacturing and research and 

development in accordance with 

Executive Order 14017 (86 FR 11849, 

March 1, 2021). Additionally, the 

companies noted that a potential ban on 

TCE would be contrary to the 

Administration’s national security 

priorities, which are to reduce supply 

chain risks by building a robust 

domestic renewable power sector, 

transitioning to a clean energy-based 

economy, growing a mature and 

competitive high-capacity battery 

industry, and leading global innovation 

and production in advanced technology 

products through a strong domestic 

manufacturing base. 

One company requested a TSCA 

section 6(g) exemption for the use of 

TCE and described the specific use of 

TCE as an ‘‘extraction solvent’’ during 

the separator manufacturing process for 

both lead-acid and lithium battery 

separators (Ref. 48). The company 

makes lead-acid and lithium battery 

separators from naphthenic process oil 

during the extrusion process in order to 

form a thin sheet or film for each 

separator. During the extrusion process, 

a precise amount of process oil must be 

removed from the separator, which 

requires the use of a solvent (i.e., TCE) 

to rapidly extract the process oil and 

leave behind the desired porosity to 

allow ion flow in each finished battery. 

The finished separators must contain a 

specific percentage of residual process 

oil that ranges between 15% to 20% for 

lead-acid battery separators (for 

oxidation resistance in the finished 

battery) and less than 1% for lithium 

separators. Once the solvent has 

removed the precise amount of oil from 

each separator, the solvent must be 

evaporated/removed from the separator, 

and post-evaporation, the separator 

must have the specific porosity and 

wettability to provide low electrical 

(ionic) resistance (i.e., enabling ion 

transport) within a battery. For these 

established separator manufacturing 

processes, TCE is a high-performance 

process solvent that provides a unique 

combination of chemical properties 

(e.g., non-flammability, rapid extrusion 

of process oil, compatibility with 

process equipment, etc.), which 

facilitate the controlled removal of 

process oil in both lead-acid and 

lithium separator production processes. 

The company also detailed that there is 

no other chemical alternative that is 

suitable or available to replace TCE in 

its lead-acid or lithium separator 

processes. 

A second company requested a TSCA 

section 6(g) exemption for the use of 

TCE as a necessary solvent for the 

manufacture of lead-acid battery 

separators and indicated that 

prohibiting the use of TCE would harm 

the U.S. manufacturing, energy, 

transportation, and defense sectors (Ref. 

49). The company describes its use of 

TCE as specific to the manufacture of 

polyethylene plate separators used by 

others in commercial wet cell batteries. 

Their lead-acid battery separators are 

made of silica, process oil, and PE resin, 

a unique polymer that is extruded into 

a sheet form using the process oil. After 

the sheet is formed, an oil-extraction 

process employs TCE to extract the 

process oil, which reduces the oil 

content within the sheet to 20–25%, 

and, once the solvent has removed the 

precise amount of oil from the lead-acid 

separator, the solvent is evaporated/ 

removed from the separator to yield the 

required porosity to allow ion flow in 

the finished battery. Finally, the 

extracted oil and 99.7% of TCE are 

captured and reused in the extraction 

process. The company notes that its 

lead-acid battery separators are essential 

in gasoline and electric-powered 

commercial vehicles, emergency 

response and military vehicles, marine 

engines, nuclear power providers, as 

well as other business sectors. The 

company further reiterates the unique 

chemical properties that are essential to 

facilitate the controlled removal of 

process oil while allowing the company 

to recover and recycle previously-used 

TCE efficiently for reuse in the battery 

separator production process in a 

manner that they describe as 

minimizing worker exposure, while 

resulting in a product with the 

characteristics required by battery 

producers. The company has provided 

details to EPA on its sophisticated 

engineering process that follows the 

hierarchy of controls to minimize 

worker exposure. This includes a 

separate enclosed structure under 

negative pressure as a work area for TCE 

processing; limiting the time personnel 

are allowed to enter spaces where they 

could be potentially exposed to 15 

minutes at a time; work area ventilation 

and filtration using carbon beds; and 

PPE including either a half-face or fullface air purifying respirator for any 

entry into the work area, as well as 

chemical-resistant gloves, chemicalresistant aprons, goggles, and face 

shields (Ref. 49, 53). 

Both companies that requested a timelimited exemption for use of TCE for 

battery separator production in the U.S. 

have demonstrated to EPA the facilityspecific research, development, and 

implementation of sophisticated control 

measures to minimize TCE exposures, 

while also searching for reasonably 

available alternative solvents and 

processes (Refs. 48, 49). 

According to the requesters, there are 

several properties that make TCE 

uniquely suitable for use in the 

manufacture of battery separators. First, 

TCE is non-flammable. According to one 

requester, the only other solvent that is 

currently in use in this application is 

hexane, which is explosive and highly 

flammable, presenting a safety risk. 

Other key properties described by the 

requesters include TCE’s rapid 

extraction of process oil, its 

compatibility with the metallurgy of the 

process equipment, the ease by which 

TCE is distilled from the process oil for 

recovery and reuse, and its vapor 

pressure that both allows for 

evaporation and permits condensation 

from the atmosphere using cooling coils. 

One requester evaluated more than a 

dozen potential alternatives, including 

hexane, other chlorinated solvents such 

as methylene chloride and 

perchloroethylene, 1-bromopropane, 

acetone, alcohols, siloxanes, and water. 

Some were eliminated as not being 

compatible with the process, such as 

water, which is not miscible with the 

process oil, so it cannot be used to 

extract the oil. Others were found to be 

much less effective than TCE at 

extracting process oils, while some were 

not as easy to recover and reuse. Even 

the more promising solvents, such as 

perchloroethylene, were not drop-in 

replacements and would, according to 

the requester, require expensive 

equipment modifications and a multiyear customer approval process. Based 

on requester submissions and EPA’s 

general understanding of the battery 

separator manufacturing process, EPA 

believes that there are no feasible 


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alternatives to TCE available at present 

(Refs. 48, 49, 52). 

One company requested a fixed 

exemption period of 25 years due to the 

critical nature of TCE use, current lack 

of any safer technologically or 

economically feasible alternative, and to 

avoid grave disruption to the U.S. 

economy, critical infrastructure, and 

defense base (Ref. 54). The company 

further explained that a restriction on 

TCE without sufficient time to identify, 

develop, and test a technically and 

economically feasible alternative 

(should such an alternative be identified 

and become available) would pose 

significant cost and safety concerns for 

the automobile and other critical 

infrastructure industries. The requester 

further explained that battery 

manufacturer customers and end users 

require compliance with strict 

performance testing, and, in addition, if 

a technically feasible alternative does 

become available, it will take multiple 

years to retrofit and obtain approvals 

required for the technical, economic and 

commercial feasibility of the separators. 

The company offered to provide EPA 

periodic reports every five years on its 

efforts to identify and assess feasible 

alternatives; in this way, EPA would 

receive ongoing alternatives analyses to 

ensure forward progress, while the 

company would obtain the regulatory 

certainty needed to maintain sustainable 

production for its customers (Ref. 48). 

Similarly, the second company 

requested a 25-year exemption from 

restrictions on this use of TCE, with an 

additional request that EPA consider 

future extensions for additional time, in 

order to allow its use of TCE until a 

safer, feasible alternative is available 

(Ref. 49). The company justified the 

lengthy exemption request by 

explaining its ongoing search for 

alternatives since 2014, and its 

estimates that, while it will be another 

five years before a suitable alternative is 

identified, the period for trial use, 

customer vetting and approval and 

construction of a new manufacturing 

plant is expected to last at least 20 

years. In addition, the second requester 

also offered to submit to EPA periodic 

reports every five years to detail their 

efforts to identify and assess feasible 

alternatives. 

Based on the information provided to 

EPA, EPA proposes that compliance at 

this time with a prohibition for this 

specific condition of use would 

significantly disrupt national security 

and critical infrastructure. EPA agrees 

that the use of lead-acid batteries and 

lithium battery separators is crucial to 

each of these sectors at this time. These 

batteries are essential for critical 

infrastructure such as transportation 

and security systems, as well as for 

energizing the national defense base 

(e.g., nuclear submarine batteries). 

Furthermore, EPA agrees that 

compliance with the prohibition would 

disrupt national security priorities of 

reducing supply chain risks by building 

a robust domestic renewable power 

sector and transitioning to a clean 

energy-based economy. 

Despite the request for a 25-year 

exemption from two separate 

companies, EPA is proposing a 10-year 

time-limited TSCA section 6(g) 

exemption. EPA believes that a 10-year 

exemption from the prohibition on TCE 

as a processing aid, specific to lead-acid 

and lithium battery separator 

manufacturing, is reasonable because it 

would be sufficient to provide EPA with 

an updated analysis of any technically 

feasible alternative, the supply chain of 

the U.S. battery industry, as well as 

global innovation and production in 

high-technology products. Under TSCA 

section 6(g), EPA can consider revisiting 

or extending time-limited exemptions 

by rulemaking until a safer, feasible 

alternative becomes available, provided 

EPA receives an updated analysis of the 

specific use. EPA considered the 

emphasis in TSCA section 6(d) that 

compliance dates be as soon as 

practicable, and that TSCA section 6(g) 

requires that any exemptions be welljustified. EPA also took into 

consideration the regulatory scheme 

under the European Chemicals Agency 

for this use of TCE for battery separator 

manufacturing, and the periodic 

reporting cycle established in the 

European Union and United Kingdom. 

In the EU and UK, authorizations are 

chemical- and facility-specific and for a 

duration of either 7 or 12 years. Under 

the current EU and UK authorizations, 

in which a panel reviewed the scientific 

and economic implications of the 

specific TCE use, each battery separator 

manufacturing company was approved 

for a 7-year authorization period (with 

a 2023 expiration date); both companies 

have applied for a renewal for an 

additional 12 years after 2023 (Ref. 55). 

Noting that this industry has been able 

to provide updated applications for 

authorization to the EU and UK in a 

renewal cycle that has been shorter than 

10 years, the two companies’ interest in 

providing periodic updates to EPA, and 

the fast pace of battery technology 

development, EPA proposes that 10 

years is sufficient for this time-limited 

exemption, and that this timeframe 

would also align with the EU and UK 

approaches. EPA requests comment on 

whether 10 years is an appropriate 

timeframe for the proposed TSCA 

section 6(g) exemption for industrial 

and commercial use of TCE as a 

processing aid for battery separator 

manufacturing (lead-acid and lithium 

battery separators). 

ii. Analysis of the Need for a TSCA 

Section 6(g)(1)(B) Exemption for TCE 

Use for DoD Naval Vessels 

During the analysis for this 

rulemaking of the use of TCE, EPA has 

identified that it is necessary to allow 

for the continued use of TCE for 

industrial uses for DoD naval vessel 

requirements for potting, bonding and 

sealing compounds, bonding and 

cleaning requirements for naval combat 

systems, radars, sensors, equipment, 

and fabrication and prototyping 

processes. 

These naval vessel-related COUs 

cover the platform itself and/or specific 

systems, equipment, or processes. The 

use of TCE for industrial uses on DoD 

naval vessels is critical and essential, 

and a prohibition for this specific 

condition of use would significantly 

disrupt national security and critical 

infrastructure. An exemption for DoD 

uses for naval vessels would enable the 

continued use of TCE for the COUs 

described which relate to vessels and 

their systems, and which enable 

maintenance, fabrication and 

sustainment and thus the operation of 

naval vessels and equipment. 

DoD has been unable to identify 

suitable alternatives for TCE for these 

uses. Based on information received 

from DoD, a 10-year timeframe for this 

exemption would prevent disruption of 

national security and allow critical 

infrastructure priorities to be met. 

iii. Analysis of the Need for TSCA 

Section 6(g)(1)(A) Exemption of TCE for 

Laboratory Use That for Essential 

Laboratory Activities 

During the analysis for this 

rulemaking of the uses of TCE, EPA 

agrees that it is necessary to allow the 

continued use of TCE for laboratory use 

for essential laboratory activities (this 

use is within the condition of use 

‘‘Industrial and commercial use of TCE 

in hoof polish; gun scrubber; pepper 

spray; and other miscellaneous 

industrial and commercial uses,’’ 

described in Unit III.B.1.c.xx.). Under 

essential laboratory activities, EPA 

includes chemical analysis, chemical 

synthesis, extracting and purifying other 

chemicals, or dissolving other 

substances. Additionally, EPA includes 

as an essential laboratory activity 

research and development for new 

technologies related to monitoring and 

remediation for cleanup activities 


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related to TCE contamination and for 

new analytical methods for exposure 

monitoring (e.g., for the ECEL). 

Under TSCA section 6(g)(1)(A), EPA 

determined that TCE use as a laboratory 

chemical for essential laboratory 

activities is a critical and essential use 

with no technically and economically 

available substitutes. The use of TCE in 

laboratory use for essential laboratory 

activities is critical for ongoing Federal, 

state, and local government cleanup 

projects, in which it is necessary to use 

TCE as a laboratory chemical for the 

analysis of TCE-contaminated soil, air, 

and water samples. In these projects 

which are specific to TCE, the 

continued use of TCE in laboratory 

settings for chemical analysis when 

applied to cleanup and exposure 

monitoring is critical to efforts to 

improve health, the environment, and 

public safety and is without a 

technically available substitute. 

Additionally, industrial laboratory 

analysis is essential in monitoring for 

the presence of TCE for the adequate 

reduction of overall exposure to TCE in 

alignment with the hierarchy of 

controls. In order to accurately conduct 

exposure monitoring of TCE to 

implement the WCPP for the uses with 

longer timeframes, industrial and 

commercial use of TCE as a laboratory 

chemical to provide for the chemical 

analysis of samples is critical and 

essential and without a technical 

alternative. A 50-year timeframe for the 

continued use of TCE for uses in a 

laboratory for chemical analysis would 

allow a sufficient time for TCE 

remediation to occur at most identified 

clean-up sites, as well as sites not yet 

identified. EPA also proposes to include 

in this exemption the use by NASA of 

TCE in essential laboratory activities as 

a laboratory reagent, calibration 

standard, and for dissolving other 

substances (Ref. 56). Following 

interagency consultation with NASA, 

EPA understands NASA’s critical use of 

TCE in laboratories to include sample 

preparation and equipment calibration 

related to the search for chlorinated 

hydrocarbons on Mars, calibration of gas 

mixture used in identification of 

contaminants in breathing air in humanrated space and aerospace systems, and 

preparation of quality assurance 

samples for groundwater analysis. EPA 

is also aware of an additional critical 

use of TCE in laboratories by NASA to 

dissolve substances, such as for wax 

removal from infrared sensors. The wax 

is applied to protect the sensors during 

the development of infrared detectors 

incorporated into specialty instruments. 

TCE is used to remove the wax, and, 

unlike other solvents, has not been 

found to damage other delicate 

components of the infrared sensors. 

As an example of this use, EPA notes 

that the devices that require this kind of 

wax removal are built in the Detector 

Development Lab, which is an 

International Standards Organization 5 

cleanroom dedicated to fabrication of 

detectors (including infra-red). The lab 

utilizes semiconductor like processes to 

create these devices in silicon wafers or 

similar substrates, through build up or 

removal of layers toward meeting NASA 

missions. Detectors and devices are 

built in the lab that are not typically 

found in industry yet are needed to 

meet NASA requirements. The devices 

built tend to be unique, one-of-a-kind 

devices created using equally unique 

and highly specialized processes. One of 

these processes uses TCE. Part of device 

fabrication requires building up or 

removing material from both sides of the 

wafer. To do so, while protecting one 

side, a sacrificial substrate is commonly 

adhered to the silicon substrate using a 

wax material as glue. In many cases, 

when the process is complete, the wax 

is dissolved away to remove the 

sacrificial substrate. Common waxes 

that achieve this process are readily 

dissolved in a polar solvent such as 

acetone. The build-up or removal of 

material is done in a manner to create 

very specific patterns with each layer. 

These patterns are transferred to the 

substrate using a polymer material 

called photoresist. Once the pattern 

transfer is complete the photoresist is 

removed using acetone or other means. 

In the case of creating certain types of 

infra-red detectors, there is a need to 

embed a photoresist pattern within the 

wax layer when gluing a sacrificial 

substrate to the silicon wafer. The 

requirement is that the patterned resist 

remain intact after dissolving the wax. 

Using solvents such as acetone would 

simultaneously dissolve the resist 

pattern or in the case of some solvents 

deform or weaken the photoresist 

beyond rendering it unusable. TCE is 

the only product identified that can 

perform this process. Specifically, TCE 

is able to dissolve the wax layer and 

leave the patterned resist layer 

uncompromised. The use of TCE is 

solely for dissolving material and is 

always used in an exhausted hood in 

the laboratory. Each hood is inspected 

yearly by an on-site Industrial Hygiene 

Office to ensure proper airflow and 

operation. The hood has a local alarm 

for airflow that is tested daily for 

operation. The clean room has vertical 

laminar air flow, pushing air into the 

exhausted hoods as air is pulled by the 

exhaust fans. The room is maintained at 

a positive pressure of 0.08 inches on 

water column. For added exposure 

reduction, the laboratory is equipped 

with a separate emergency exhaust fan 

which, if activated, creates a negative 

pressure in the laboratory. All 

potentially exposed persons are 

provided a full set of PPE that includes 

apron with arm guards, face shield, 

safety glasses, standard issue nitrile 

gloves and chemical gloves rated for 

chlorinated solvents. 

The process consists of the following 

steps: First, the wafer is soaked in 200– 

2000 mL of TCE (volume dependent on 

wafer size). When the wax is fully 

dissolved, the wafer is transferred to a 

second (fresh) TCE container of 200– 

2000mL and soaked for several minutes. 

Then, the effluent is rinsed with deionized water and the waste TCE is 

captured in waste containers for 

disposal by an on-site Environmental 

Group. This process is conducted over 

the span of approximately one week and 

is required an average of 3 times per 

year. When the process is complete all 

chemicals are disposed of or stored in 

screw capped bottles within an 

exhausted enclosure. Based on the 

information available to EPA, EPA is 

including the use of TCE in laboratories 

by NASA to dissolve substances as part 

of the proposed exemption for use of 

TCE in laboratories for essential 

laboratory activities. In addition, based 

on the information provided by NASA 

and other Federal agencies, EPA has 

considered and is including in this 

proposal an exemption for additional 

research and development activities and 

test and evaluation method activities, 

and similar laboratory activities, 

conducted by Federal agencies and their 

contractors, provided the use is 

essential to the agency’s mission. As 

described more fully in Unit V.A.3.a.vi., 

for example, NASA’s mission requires 

that it operate at the cutting edge of 

science, in environments that are hostile 

to life, especially human life. While 

NASA is skilled at addressing problems 

presented by these environments, EPA 

is concerned that the proposed limits on 

this laboratory use exemption in general 

would negatively affect NASA’s ability 

to respond to issues that arise in 

spaceflight, particularly human 

spaceflight. Similarly, EPA believes that 

the DoD’s unique mission requires 

additional flexibilities for research and 

development in order to maintain 

military readiness at all times. 

It should be noted that the use of TCE 

in laboratory settings for testing asphalt 

would not be included in this TSCA 

section 6(g) exemption because it is not 

critical nor essential, and because 

alternative testing methods exist, 


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including the Nuclear Asphalt Content 

Gauge and the Ignition Method (Ref. 57). 

EPA requests comment on whether 50 

years is a reasonable timeframe for the 

TSCA section 6(g) exemption for the 

industrial and commercial use of TCE in 

laboratory use essential for chemical 

analysis. Specifically, EPA requests 

comment on the anticipated duration of 

TCE cleanup projects, and whether 

there will be projects that continue and 

require the use of TCE as a laboratory 

chemical for the analysis of 

contaminated soil, air, and water 

samples past 50 years. Additionally, 

EPA requests comment on if the 

exemption for laboratory use of TCE 

should include research and 

development purposes for objectives 

broader than cleanup activities or 

exposure monitoring, such research into 

TCE alternatives, whether these broader 

objectives should be limited to Federal 

agencies and their contractors or 

expanded to include others, and 

whether a shorter time period, such as 

10 years, should be imposed on these 

broader research and development 

activities. 

iv. Analysis of the Need for a TSCA 

Section 6(g)(1)(A) Exemption for 

Disposal of TCE to Industrial PreTreatment, Industrial Treatment, or 

Publicly Owned Treatment Works for 

the Purposes of Cleanup Projects of 

TCE-Contaminated Groundwater and 

Other Wastewater 

EPA has conducted an analysis of the 

application of this rulemaking and 

found that the disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works for the purposes of cleanup 

projects of TCE-contaminated 

groundwater and other wastewater 

should be permitted to continue for 

some period of time to avoid adverse 

impacts on these important remediation 

projects. 

TCE is a contaminant of concern in a 

significant number of cleanup sites that 

are managed under the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA), also known as Superfund 

sites, as well as under the Resource 

Conservation and Recovery Act (RCRA) 

and state programs authorized under 

RCRA. The remediation of these sites, 

including the removal and treatment of 

TCE-contaminated groundwater, is 

critical to EPA’s mission to protect 

human health and the environment. The 

disposal of wastewater that contains 

TCE to industrial pre-treatment, 

industrial treatment, or publicly owned 

treatment works is an important method 

used in these cleanup efforts. In EPA’s 

analysis of this rulemaking, EPA 

determined that at many contaminated 

sites, TCE-contaminated wastewater is 

pumped out of the ground and either 

sent to offsite industrial treatment or 

publicly owned treatment works. EPA 

acknowledges that the cleanup of these 

sites is vital work in which the disposal 

of TCE is a critical or essential use for 

which no technically and economically 

feasible safer alternative is available that 

must continue under CERCLA, RCRA, 

authorized state programs, and/or orders 

or permits issued under those 

authorities. Taking into consideration 

hazards and exposure, a prohibition on 

disposal without this exemption could 

result in prolonged exposure to TCEcontaminated groundwater for affected 

communities. EPA is concerned that 

eliminating a common disposal method 

for TCE-contaminated groundwater 

would be a significant burden on these 

cleanups and would likely slow the 

pace of remediation at the numerous 

sites where TCE-contaminated 

groundwater is a problem. EPA also 

understands that there are other sites 

where TCE-contaminated groundwater 

is being addressed under the authority 

of other federal environmental laws or 

state and local government authorities, 

including at sites that are currently 

implementing remedies selected 

through relevant statutory and 

regulatory processes, and the impact of 

a prohibition on an important disposal 

method is expected to be similar. EPA 

therefore is proposing a 50-year 

exemption from the prohibition on 

disposal of TCE by industrial pretreatment, industrial treatment, or 

publicly owned treatment works for 

cleanup projects undertaken under the 

authority of CERCLA, RCRA, or other 

federal, state, or local government 

environmental laws, regulations, or 

requirements. 

A 50-year timeframe for the continued 

disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works for the 

purposes of federal, state, and local 

government cleanup projects would 

allow a sufficient time for TCE 

remediation to occur at most sites. 

Additionally, the 50-year timeframe 

aligns with the proposed 50-year timelimited TSCA section 6(g)(1)(A) 

exemption for industrial and 

commercial use of TCE as a laboratory 

chemical in essential laboratory 

activities, which is also intended to 

support cleanup operations through 

allowing for the analysis of samples. 

EPA requests comment on whether 50 

years is a reasonable timeframe for a 

TSCA section 6(g)(1)(A) exemption for 

the cleanup of TCE-contaminated water 

and groundwater sites. Specifically, 

EPA requests comment on the 

anticipated duration of TCE cleanup 

projects, and whether there will be 

projects that may continue and require 

the disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works beyond 

50 years. 

v. Analysis of the Need for a TSCA 

Section 6(g)(1)(B) Exemption for 

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 

EPA has conducted an analysis of the 

application of this rulemaking to 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 and proposes to find that a 

TSCA section 6(g) exemption is 

warranted. Under TSCA section 

6(g)(1)(B), EPA proposes to determine 

that a prohibition at this time on the 

manufacture, processing, and 

distribution in commerce of TCE as a 

solvent for closed-loop vapor degreasing 

for human-rated rocket engine cleaning 

by NASA and its contractors would 

significantly disrupt national security 

and critical infrastructure. 

The United States Space Priorities 

Framework notes that space systems 

(e.g., flight components of satellites and 

space craft) are part of the nation’s 

critical infrastructure and that the 

United States has significant national 

security interests in space (Ref. 58). 

NASA operates on the leading edge of 

science seeking innovative solutions to 

future problems in environments that 

offer little to no margin for error. 

Identification and qualification of 

compatible materials in the context of 

the less forgiving environments in 

which NASA operates is an iterative, 

collaborative process between original 

equipment manufacturers and NASA, 

especially in the case of human space 

flight operations (Ref. 59). NASA’s 

mission architecture requirements often 

are developed many years in advance of 

an actual launch occurring. As part of 

mission planning, space systems are 

designed, full scale mock-ups are built, 

and mission critical hardware is 

constructed using materials qualified for 

spaceflight. According to NASA, for 

Artemis Program applications, in 

particular, losing access to a qualified 

high-performance substance like TCE in 

a short period of time has the potential 

to introduce an unacceptable level of 


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risk to crew, vehicle, and mission 

viability (Ref. 43). 

As described by NASA, their use of 

TCE in closed-loop vapor degreasing 

involves cleaning small diameter parts, 

such as rocket engine nozzle coolant 

tubes, and removing the fluids used for 

manufacturing. Substitutes for TCE and 

alternative processes do not meet the 

technical specifications required to 

clean certain complex aerospace parts, 

namely small diameter parts. 

Specifically, these small diameter parts 

cannot be cleaned with other solvents 

due to the likelihood of entrapment 

issues (i.e., a solvent carried out of a 

degreaser that adheres to or is entrapped 

in the part being removed) (Ref. 60). As 

discussed in Unit V.B.3.a.i., similar 

concerns have been expressed by a 

manufacturer of commercial jetliners 

and defense, space, and security 

systems, although the manufacturer 

states that potential alternatives have 

been identified for nearly all 

applications. Given that the small 

diameter parts identified by NASA are 

for human-rated space flight, there is a 

rigorous safety standard that must be 

met, and according to NASA, TCE is the 

only solvent currently qualified for 

degreasing these specific parts. The 

engines and devices in which these 

parts are used include Space Shuttle 

engines or hardware being reused; 

others are designed to leverage proven 

Space Shuttle technology and require 

use of certain fluids, such as TCE, that 

have been qualified for human space 

flight. 

EPA notes that this proposed 

exemption of use of TCE as a solvent in 

closed loop vapor degreasing necessary 

for human-rated rocket engine cleaning 

by NASA and its contractors differs 

from the exemption for TCE in vapor 

degreasing for essential aerospace parts 

and components, described in the 

primary alternative regulatory action. As 

a principal matter, this proposed 

exemption is limited only to NASA and 

its contractors due to the critical 

infrastructure and national security 

needs of human-rated spaceflight rocket 

engines. In contrast, the alternative is 

much broader and covers all aerospace 

entities, including commercial aviation. 

This proposed exemption also differs 

from the alternative regulatory action in 

that the exemption is limited to use of 

TCE only in closed-loop vapor 

degreasing, while the alternative 

regulatory action would provide an 

exemption under TSCA section 6(g) for 

7 years before prohibition for all vapor 

degreasing with TCE (e.g., open top, inline conveyorized, in-line web cleaner, 

and other types of vapor degreasing in 

addition to closed loop). Vapor 

degreasing as an industry has some of 

the higher exposures of TCE to workers 

and ONUs and this industry would have 

to make significant changes in order to 

comply to the extent possible with a 

WCPP until prohibition. However, of 

the types of vapor degreasing processes, 

closed-loop vapor degreasing has the 

lowest exposures to TCE for workers 

and ONUs, and as such, facilities with 

a closed-loop process are best situated 

to comply with an interim WCPP and to 

the extent possible, meet the ECEL until 

prohibition. Further, EPA believes that 

the facilities involved in this particular 

application of vapor degreasing for 

human-rated rocket engine cleaning by 

NASA or their contractors already have 

sophisticated industrial hygiene plans 

in place. EPA notes that a prohibition 

on vapor degreasing with TCE for all 

uses was proposed in 2017 (Ref. 67). 

While that proposal was withdrawn 

pending the completion of a risk 

evaluation for TCE under amended 

TSCA, which evaluated all conditions of 

use including vapor degreasing, EPA 

expects that since the 2017 proposal, 

certain stakeholders have made 

significant progress in identifying and 

adopting substitutes for vapor 

degreasing with TCE in anticipation of 

potential restrictions on TCE under 

amended TSCA. For instance, EPA is 

aware that many users have transitioned 

to a substitute for TCE in vapor 

degreasing where possible or are 

planning for technologically feasible 

adjustments (Refs. 32, 43. 60). EPA 

requests comment on whether 7 years is 

an appropriate timeframe for the 

proposed TSCA section 6(g) exemption 

for industrial and commercial use of 

TCE in closed loop vapor degreasing 

necessary for human-rated rocket engine 

cleaning by NASA and its contractors. 

vi. Analysis of the Need for TSCA 

Section 6(g)(1)(A) Exemption for Certain 

NASA Uses in an Emergency for Which 

No Technically or Economically 

Feasible Safer Alternative is Available 

EPA considered a TSCA section 6(g) 

exemption for emergency use of TCE in 

the furtherance of NASA’s mission. For 

certain specific conditions of use, EPA 

proposes that use of TCE by NASA and 

its contractors in an emergency be 

exempt from the requirements of this 

rule because it is a critical or essential 

use provided that (1) there is an 

emergency; and (2) NASA selected TCE 

because there are no technically or 

economically feasible safer alternatives 

available during the emergency. 

NASA operates on the leading edge of 

science seeking innovative solutions to 

future problems where even small 

volumes of an otherwise prohibited 

chemical substance could be vital to 

crew safety and mission success. During 

interagency review, NASA expressed 

concerns that there will likely be 

circumstances where a specific, EPAprohibited condition of use may be 

identified by NASA during an 

emergency as being needed in order to 

avoid or reduce situations of harm or 

immediate danger to human health, or 

the environment, or avoid imperiling 

NASA space missions. In such cases, it 

is possible that no technically and 

economically feasible safer alternative 

would be available that meets the 

stringent technical performance 

requirements necessary to remedy harm 

or avert danger to human health, the 

environment, or avoid imperiling NASA 

space missions. 

An emergency is a serious and sudden 

situation requiring immediate action to 

remedy harm or avert danger to human 

health, the environment, or to avoid 

imperiling NASA space missions. In 

NASA’s case, there may be instances 

where the emergency use of TCE for 

specific conditions of use is critical or 

essential to remedying harm or averting 

danger to human health, the 

environment, or avoiding imperiling 

NASA space missions. Because of the 

immediate and unpredictable nature of 

emergencies described in this unit and 

of the less forgiving environments 

NASA operates in that offer little to no 

margin for error, it is likely that, at the 

time of finalization of this proposal, 

alternatives to emergency TCE use may 

not be available in a timely manner to 

avoid or reduce harm or immediate 

danger (Ref. 59). In this way, these 

emergencies for particular conditions of 

use meet the criteria for an exemption 

under TSCA section 6(g)(1)(A), because 

the emergency use of TCE for listed 

conditions of use is critical or essential 

and no technically and economically 

feasible safer alternative will be 

available in a timely manner, taking into 

consideration hazard and exposure. 

In support of the TSCA section 

6(g)(1)(A) emergency use exemption, 

NASA submitted detailed criteria which 

they must use to screen, qualify, and 

implement materials to be used in 

spacecraft equipment, as well as 

historical case studies that outline the 

loss of life and loss of assets in the 

discharge of previous missions. In one 

of several examples detailed, the Apollo 

I command module fire that claimed the 

lives of three American astronauts 

demonstrated the need for careful 

testing and continuity of materials (Ref. 

59). Moreover, due to NASA’s rigorous 

safety testing requirements under 

various environmental conditions, 

technically and economically feasible 


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safer alternatives may not be readily 

available during emergencies and may 

require certain conditions of use of TCE 

to alleviate the emergency. 

In another example, NASA identified 

a scenario concerning a mission to the 

International Space Station (ISS) 

whereby, during a launch evolution, the 

countdown was paused immediately 

prior to launch (T–2 minutes). NASA 

engineers identified a clogged filter and 

supply line as the primary issue, which 

required immediate attention (i.e., line 

flushing and filter cleaning). In this type 

of emergency scenario, an already 

approved chemical substance rated for 

space system applications is necessary 

to immediately remedy the situation. 

Although TCE was not used in this 

particular incident, if it were needed in 

the future to address such an 

emergency, then the proposed 

exemption would allow for its lawful 

use—the countdown would resume and 

the launch would occur. Conversely, 

without an exemption under the 

specific condition of use (e.g., industrial 

and commercial use in cold cleaning), 

NASA’s use of TCE would be otherwise 

prohibited, which would put NASA in 

an untenable position of having to 

choose to either violate the law or place 

the mission (and potentially the health 

and safety of its employees involved in 

the mission) at risk. 

The identification and qualification of 

compatible materials in the context of 

aviation is iterative and involves 

expansive collaboration between 

original equipment manufacturers, 

federal agencies, and qualifying 

institutions. This is equally, if not more 

so, the case in the context of human 

space flight operations undertaken by 

NASA (Ref. 59). NASA’s mission 

architecture requirements often are 

developed many years in advance of an 

actual launch occurring. As part of 

mission planning, space systems are 

designed, full scale mock-ups are built, 

and mission critical hardware is 

constructed using materials qualified for 

spaceflight. Once NASA’s mission 

architecture requirements are 

developed, NASA may need to retain 

emergency access to TCE because its 

alternatives may not have yet gone 

through NASA’s rigorous certification 

process before their use. Allowing 

NASA to retain emergency use of TCE 

would reduce the chances that this rule 

will hinder future space missions for 

which mission architecture 

infrastructure is being developed or is 

already built. While NASA considers 

alternatives to the chemical substances 

it currently uses in its space system 

designs, NASA has not yet identified 

technically and economically feasible 

alternatives to proven chemistries in 

many current applications. While EPA 

acknowledges that the use of TCE in 

emergency situations may be necessary 

in the near term, it is also EPA’s 

understanding that NASA will continue 

its work to identify and qualify 

alternatives to TCE. Thus, EPA is 

proposing an exemption duration of 10 

years. 

b. Proposed TSCA Section 6(g) 

Exemptions 

i. Proposed 10-Year Exemption for 

Industrial and Commercial Use of TCE 

as a Processing Aid for Battery Separator 

Manufacturing (Lead-Acid and Lithium 

Battery Separators) 

For the reasons discussed in this unit, 

EPA is proposing a 10-year exemption 

from the prohibition on the industrial 

and commercial use of TCE as a 

processing aid, specific to battery 

separator manufacturing. The proposed 

conditions for the exemption are: (1) 

The use of TCE would be limited to use 

as a processing aid for battery separator 

manufacturing to supply the essential 

battery components to continue to 

support the national economy, national 

security, and critical infrastructure; (2) 

This specific industrial and commercial 

use of TCE as a processing aid would be 

required to be conducted at industrial 

facilities already using TCE to 

manufacture the lithium ion or lead acid 

separators; and (3) Owners or operators 

of facilities where TCE is used as a 

processing aid for battery separator 

manufacturing and entities that 

manufacture (including import) TCE as 

a processing aid would be required to 

comply with the WCPP requirements 

described in Unit V.A.2. until the 

expiration of the exemption and the 

prohibition compliance date. 

ii. Proposed 10-Year Exemption for TCE 

for Industrial Uses for DoD Naval Vessel 

Requirements 

For reasons discussed in this unit, 

EPA is proposing a 10-year exemption 

from the prohibition on industrial and 

commercial use of TCE for 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. The proposed conditions for 

the exemption are: (1) The use of TCE 

would be limited to use only for DoD 

naval vessels and their systems, and in 

the maintenance, fabrication, and 

sustainment for and of such vessels and 

systems; and (2) Owners or operators of 

facilities where TCE is used for DoD 

naval vessels and entities that 

manufacture (including import) or 

process TCE for use in DoD naval 

vessels would be required to comply 

with the WCPP requirements described 

in Unit V.A.2. until the expiration of the 

exemption and the prohibition 

compliance date. 

iii. Proposed 50-Year Exemption for 

TCE Laboratory Use for Essential 

Laboratory Activities 

For the reasons discussed in this unit, 

EPA is proposing a 50-year exemption 

from the prohibition on industrial and 

commercial use of TCE, for other 

miscellaneous industrial and 

commercial use of TCE in laboratory use 

for essential laboratory activities, 

excluding the testing of asphalt, as 

previously discussed. The proposed 

conditions for the exemption are: (1) 

The use of TCE would be limited to use 

in an industrial or commercial 

laboratory for essential laboratory 

activities, including chemical analysis, 

chemical synthesis, extracting and 

purifying other chemicals, dissolving 

other substances, and research and 

development for the advancement of 

cleanup activities and analytical 

methods for monitoring related to TCE 

contamination or exposure monitoring, 

with the exclusion of laboratory testing 

for asphalt; (2) Federal agencies and 

their contractors would be permitted to 

conduct research and development 

activities and test and evaluation 

method activities, and similar laboratory 

activities, provided the use is essential 

to the agency’s mission; and (3) Owners 

or operators of facilities where TCE is 

used in laboratory settings and entities 

that manufacture (including import) or 

process TCE for use as a laboratory 

chemical would be required to comply 

with the WCPP requirements described 

in Unit V.A.2. until the expiration of the 


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exemption and the prohibition 

compliance date. 

iv. Proposed 50-Year Exemption for 

Disposal of TCE to Industrial PreTreatment, Industrial Treatment, or 

Publicly Owned Treatment Works for 

the Purposes of Cleanup Projects of 

TCE-Contaminated Groundwater and 

Other Wastewater 

For the reasons discussed in this Unit, 

EPA is proposing a 50-year exemption 

from the prohibition on disposal of TCE 

to industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works for the purposes of cleanup 

projects of TCE-contaminated 

groundwater and other wastewater. The 

proposed conditions for the exemption 

are: (1) The disposal of TCE to industrial 

pre-treatment, industrial treatment, or 

publicly owned treatment works would 

only be permitted for the purposes of 

cleanup projects of TCE-contaminated 

water and groundwater at sites 

undergoing remediation under CERCLA, 

RCRA, or other Federal, state, and local 

government laws, regulations or 

requirements; and (2) Owners and 

operators of the locations where workers 

are handling TCE wastewater, and 

owners and operators of facilities where 

TCE is disposed to industrial pretreatment, industrial treatment, or 

publicly owned treatment works, would 

be required to comply with the WCPP 

requirements described in Unit V.A.2. 

and the recordkeeping requirements 

described in Unit V.A.4. until the 

expiration of the exemption and the 

prohibition compliance date. 

v. Proposed 7-Year Exemption for 

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 

For the reasons discussed in this unit, 

EPA is proposing a 7-year exemption 

from the prohibition 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, 

and the manufacture (including import), 

processing, and distribution in 

commerce of TCE for this use. The 

proposed conditions for the exemption 

are: (1) The use of TCE would be limited 

to closed-loop vapor degreasing 

necessary for human-rated rocket engine 

cleaning by NASA and its contractors; 

and (2) Owners or operators of facilities 

where TCE is used in closed-loop vapor 

degreasing necessary for human-rated 

rocket engine cleaning by NASA and its 

contractors, and entities that 

manufacture (including import) or 

process TCE for such use, would be 

required to comply with the WCPP 

requirements described in Unit V.A.2. 

until the expiration of the exemption 

and the prohibition compliance date. 

vi. Proposed Exemption for Uses of TCE 

for Emergency Uses in the Context of 

Human Space Flight for Certain Uses 

For the reasons discussed in this Unit, 

EPA is proposing a 10-year exemption 

for emergency use of TCE in furtherance 

of NASA’s mission for the following 

specific conditions of use: 

(1) Industrial and commercial use as 

solvent for open-top or closed-loop 

batch vapor degreasing; 

(2) Industrial and commercial use as 

a solvent for cold cleaning; 

(3) Industrial and commercial use as 

a solvent for aerosol spray degreaser/ 

cleaner and mold release; 

(4) Industrial and commercial use as 

a lubricant and grease in tap and die 

fluid; 

(5) Industrial and commercial use as 

a lubricant and grease in penetrating 

lubricant; 

(6) Industrial and commercial use as 

an adhesive and sealant in solventbased adhesives and sealants; 

(7) Industrial and commercial as a 

functional fluid in heat exchange fluid; 

(8) Industrial and commercial use in 

corrosion inhibitors and anti-scaling 

agents; and 

(9) Industrial and commercial use of 

TCE as a processing aid. 

EPA is also proposing to include 

additional requirements as part of the 

exemption, pursuant to TSCA section 

6(g)(4), including required notification 

and controls for exposure, to the extent 

feasible: (1) NASA and its contractors 

must provide notice to the EPA 

Administrator of each instance of 

emergency use within 15 days; and (2) 

NASA and its contractors would have to 

comply with the ECEL. 

EPA is proposing to require that 

NASA notify EPA within 15 days of the 

emergency use. The notification would 

include a description of the specific use 

of TCE in the context of one of the 

conditions of use for which this 

exemption is being proposed, an 

explanation of why the use described 

qualifies as an emergency, and an 

explanation with regard to the lack of 

availability of technically and 

economically feasible alternatives. 

EPA expects NASA and its 

contractors have the ability to 

implement a WCPP as described in Unit 

V.A.2. for the identified uses in the 

context of an emergency, to some extent 

even if not to the full extent of WCPP 

implementation. Therefore, EPA is 

proposing to require that during 

emergency use, NASA must comply 

with the ECEL to the extent technically 

feasible in light of the particular 

emergency. 

Under the proposed exemption, 

NASA and its contractors would still be 

subject to the proposed general 

recordkeeping requirements discussed 

in Unit V.A. 

EPA requests comment on this TSCA 

section 6(g) exemption for continued 

emergency use of TCE in the furtherance 

of NASA’s mission as described in this 

Unit, and whether any additional 

conditions of use should be included, in 

particular for any uses qualified for 

space flight for which no technically or 

economically feasible safer alternative is 

available. Additionally, EPA requests 

comment on what would constitute 

sufficient justification of an emergency. 

4. Other Requirements 

a. Recordkeeping 

In addition to the recordkeeping 

requirements for the WCPP outlined in 

this unit, for conditions of use that 

would not otherwise be prohibited one 

year after the effective date of this 

proposed regulation, EPA is also 

proposing that manufacturers, 

processors, distributors, and commercial 

users maintain ordinary business 

records, such as invoices and bills-oflading, that demonstrate compliance 

with the prohibitions, restrictions, and 

other provisions of this proposed 

regulation; and to maintain such records 

for a period of 5 years from the date the 

record is generated. EPA is proposing 

that this compliance date would begin 

at the effective date of the rule (60 days 

following publication of the final rule in 

the Federal Register). Recordkeeping 

requirements would ensure that owners 

or operators can demonstrate 

compliance with the regulations if 

necessary. EPA may require more, less, 

or different documentation in the final 

rule based on consideration of public 

comments. 

b. Downstream Notification 

For conditions of use that are not 

otherwise prohibited under this 

proposed regulation, EPA is proposing 

that manufacturers (including 

importers), processors, and distributors, 

excluding retailers, of TCE and TCEcontaining products provide 

downstream notification of the 

prohibitions through the Safety Data 

Sheets (SDS) required by OSHA under 

29 CFR 191.1200(g) by adding to 

sections 1(c) and 15 of the SDS the 

following language: 

After [DATE 6 MONTHS AFTER 

DATE OF PUBLICATION OF THE 


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FINAL RULE IN THE FEDERAL 

REGISTER], this chemical/product is 

and can only be domestically 

manufactured, imported, processed, or 

distributed in commerce for the 

following purposes until the following 

prohibitions take effect: (1) Processing 

as an intermediate (a) for the 

manufacture of HFC–134a until [DATE 

8.5 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER] and (b) 

for all other processing as a reactant/ 

intermediate until [DATE 2 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER]; (2) Industrial and 

commercial use as a solvent for opentop batch vapor degreasing until [DATE 

1 YEAR AFTER DATE OF 

PUBLICATION OF FINAL RULE IN 

THE FEDERAL REGISTER]; (3) 

Industrial and commercial use as a 

solvent for closed-loop batch vapor 

degreasing until [DATE 1 YEAR AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], except for industrial and 

commercial use as a solvent for closedloop batch vapor degreasing necessary 

for human-rated rocket engine cleaning 

by NASA and its contractors until 

[DATE 7 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], and 

except 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 until [DATE 10 

YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]; (4) 

Industrial and commercial use in 

processing aid a) for battery separator 

manufacturing until [DATE 10 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER] and b) in process solvent 

used in polymer fiber spinning, 

fluoroelastomer manufacture and 

Alcantara manufacture; in extraction 

solvent used in caprolactam 

manufacture; and in precipitant used in 

beta-cyclodextrin manufacture until 

[DATE 2 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]; (5) 

Industrial and commercial uses for DoD 

naval vessels and their systems, and in 

the maintenance, fabrication, and 

sustainment for and of such vessels and 

systems until [DATE 10 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER]; and (6) Industrial and 

commercial use for laboratory use for 

essential laboratory activities until 

[DATE 50 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. 

The intention of downstream 

notification is to spread awareness 

throughout the supply chain of the 

restrictions on use of TCE under TSCA 

as well as provide information to 

commercial end users about allowable 

uses of TCE until the prohibition 

compliance dates. 

To provide adequate time to update 

the SDS and ensure that all products in 

the supply chain include the revised 

SDS, EPA is proposing a two-month 

period for manufacturers and a sixmonth period for processors and 

distributers to implement the proposed 

SDS changes following publication of 

the final rule. 

EPA requests comments on the 

appropriateness of identified 

compliance timeframes for 

recordkeeping and downstream 

notification requirements described in 

this unit. 

B. Primary Alternative Regulatory 

Action 

As indicated by TSCA section 

6(c)(2)(A)(iv)(II) through (III), EPA must 

consider and publish a statement based 

on reasonably available information 

with respect to the reasonably 

ascertainable economic consequences of 

the rule, including consideration of the 

costs and benefits and the cost 

effectiveness of the proposed regulatory 

action and one or more primary 

alternative regulatory actions 

considered by the Agency. This unit 

includes a description of the primary 

alternative regulatory action considered 

by the Agency. An overview of the 

proposed regulatory action and primary 

alternative regulatory actions for each 

condition of use is in Unit V.C. 

The primary alternative regulatory 

action described in this notice of 

proposed rulemaking (NPRM) and 

considered by EPA combines 

prohibitions and requirements for a 

WCPP. While in some ways it is similar 

to the proposed regulatory action, the 

primary alternative regulatory action 

described in this NPRM differs from the 

proposed regulatory action by providing 

longer timeframes for prohibitions, and 

by describing an ECEL based on a 

different health endpoint (i.e., 

immunotoxicity), as part of the WCPP 

that would be required for the 

conditions of use of TCE that would be 

permitted to continue for longer than 

one year after publication of the final 

rule until the prohibition compliance 

dates. As described in Unit IV.B., this 

ECEL is based on the endpoint used for 

EPA’s unreasonable risk determination 

for TCE under TSCA, (i.e., 

immunotoxicity (Ref. 2), rather than the 

most sensitive health endpoint 

(developmental toxicity), which is the 

basis for the ECEL for the WCPP under 

the proposed regulatory action (the 

rationale for these differences is 

described in Unit VI.A.1.a.). EPA 

requests comment on this primary 

alternative regulatory action and 

whether any elements of this primary 

alternative regulatory action described 

in this unit should be considered as 

EPA develops the final regulatory 

action. For example, EPA could finalize 

a rule that includes the longer 

timeframes for prohibitions that are 

included in this primary alternative 

regulatory action and the ECEL based on 

the fetal cardiac defects endpoint 

(0.0011 ppm) that is included in the 

proposed regulatory action. EPA also 

requests comment on the practicability 

of the timeframes outlined in this unit 

compared to the timeframes identified 

for the proposed regulatory action in 

Unit V.A. 

1. Prohibitions 

The primary alternative regulatory 

action considered by EPA would 

prohibit the manufacture (including 

import) and processing of TCE for all 

uses; prohibit the distribution in 

commerce and industrial and 

commercial use of TCE, as well as 

prohibitions on the disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works. The primary alternative 

regulatory action includes longer 

compliance timeframes for all 

prohibitions. 

Under the primary alternative action, 

the prohibitions would follow a 

staggered schedule and would generally 

take effect three months later than in the 

proposed regulatory action. Under a 

compliance timeframe that would be 

three months longer than the proposed 

regulatory action, the prohibitions for 

the manufacturing (including import) 

and processing would come into effect 

in 180 days (6 months) for 

manufacturers and 270 days (9 months) 

for processors, except for the 

manufacturing and processing 

associated with certain processing and 

industrial and commercial uses 

described later in this unit, due to 

supply chain considerations. Associated 

with this prohibition, EPA would 

prohibit the manufacturing (including 

import) and processing for all uses, 

including for all consumer uses, under 

the primary alternative regulatory 

action. 


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The prohibition compliance dates for 

most industrial and commercial users 

would be one year after the publication 

of the final rule under the primary 

alternative regulatory action. However, 

under the primary alternative regulatory 

action, there would be longer 

timeframes for the prohibition of some 

industrial and commercial uses and for 

the associated manufacturing (including 

import) and processing. For all 

manufacturing (including import), 

processing, and industrial and 

commercial use of TCE that would 

continue more than one year after the 

publication of the final rule, the WCPP 

would be in effect until the respective 

prohibition compliance dates or, if 

applicable, expiration of the TSCA 

section 6(g) exemption. The WCPP 

under the primary alternative would 

include an ECEL of 0.004 ppm, as 

described in Units IV.B. and V.B.2. 

Furthermore, to aid with the 

implementation of the prohibitions 

under the primary alternative regulatory 

action, the prohibitions on distribution 

in commerce of TCE would take effect 

concurrent with the compliance date for 

the prohibition on the manufacture and 

processing TCE for a particular 

condition of use. 

For the two conditions of use that 

encompass industrial and commercial 

batch vapor degreasing (i.e., open-top 

and closed-loop), prohibitions under the 

primary alternative regulatory action 

described in this unit would take effect 

in 24 months for manufacturers, in 27 

months for processors, and in 30 

months for the industrial and 

commercial users of TCE used as a 

solvent for open-top and closed-loop 

batch vapor degreasing after the 

publication date of the final rule (with 

the exception of 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, 

which is described in Unit V.B.3.). 

For certain processing and industrial 

and commercial conditions of use, the 

prohibitions under the primary 

alternative regulatory action described 

in this unit would take effect in two and 

a half years after the publication date of 

the final rule for manufacturers and in 

three years after the publication date of 

the final rule for processors for two 

conditions of use: (1) Processing as a 

reactant/intermediate, and (2) Industrial 

and commercial use as a 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. Additionally, a TSCA 

section 6(g) exemption would be part of 

the primary alternative regulatory action 

for the industrial and commercial use of 

TCE as a processing aid (specifically for 

battery separator manufacture) and 

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 (see Unit V.B.3.). 

Furthermore, compliance dates for 

prohibition would vary for processing 

TCE as an intermediate (specifically for 

HFC–134a manufacture), which would 

be subject to a longer phaseout, and for 

the prohibition of processing TCE as a 

reactant/intermediate. Under the 

primary alternative regulatory action, 

the manufacturing (including import) 

and processing of TCE as an 

intermediate for the manufacture of 

HFC–134a would be prohibited. Under 

the primary alternative regulatory 

action, there would be a nine-and-ahalf-year phaseout (with an extra year to 

start compliance compared to the eightand-a-half-year phaseout for the 

proposed regulatory action) following 

the requirements discussed in this unit. 

Under the primary alternative regulatory 

action, the prohibition would start one 

year later than under the proposed 

regulatory action, and thus the 

compliance timeframe would be one 

year longer than under the proposed 

regulatory action described in Unit 

V.A.1.b. Under the primary alternative 

regulatory action, a phaseout on 

processing of TCE as an intermediate for 

the manufacture of HFC–134a would 

begin at the final rule’s effective date 

and end nine years and six months after 

the publication of the final rule. Within 

18 months after the publication of the 

final rule, any facility using TCE as a 

feedstock to manufacture HFC–134a in 

the United States would establish a 

baseline within 12 months after the 

publication of the final rule of the 

annual quantity of TCE processed by the 

facility as a feedstock to manufacture 

HFC–134a. While this is similar to the 

proposed regulatory action, the 

timeframes allowed for establishment of 

the baseline would be longer under the 

primary alternative regulatory action. 

The manufacturer would use the 

average of any 12 consecutive months in 

the preceding 36 months to calculate the 

baseline and would have records that 

demonstrate how the baseline annual 

volume was calculated. Following the 

establishment of a baseline volume, 

under the alternative regulatory action, 

following a similar four-step phaseout 

process described in Unit V.A., the 

following compliance dates would take 

effect after the publication of the final 

rule: (1) In three years and six months 

each manufacturer of HFC–134a who 

uses TCE as an intermediate would not 

be permitted to process TCE as an 

intermediate at an annual volume 

greater than 75 percent of the baseline 

so established; (2) In five years and six 

months each manufacturer of HFC–134a 

who uses TCE as an intermediate would 

not be permitted to process TCE as an 

intermediate at an annual volume 

greater than 50 percent of the baseline 

so established; (3) In seven years and six 

months each manufacturer of HFC–134a 

who uses TCE as an intermediate would 

not be permitted to process TCE as an 

intermediate at an annual volume 

greater than 25 percent of the baseline 

so established; and (4) In nine years and 

six months each manufacturer of HFC– 

134a would be prohibited from using 

TCE as an intermediate. Additionally, 

manufacturing (including import) for 

this condition of use and distribution in 

commerce for this condition of use 

would follow a corresponding longer 

phaseout timeframe to account for the 

availability of TCE through the supply 

chain during the period of the phaseout 

of processing TCE as an intermediate for 

the manufacture of HFC–134a. Under 

the primary alternative regulatory 

action, regulated entities would keep 

records of the annual quantity of TCE 

purchased and processed from the year 

2024 until the termination of all 

processing of TCE as an intermediate. 

EPA requests comment on the 

practicability of the timeframes outlined 

in this unit compared to the timeframes 

identified for the proposed regulatory 

action in Unit V.A.1.c., including 

consideration of the need for 

manufacturing (including import), and 

distribution in commerce to continue 

during the period of the phaseout. 

Furthermore, with regard to the 

prohibition of the disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works, under the primary alternative 

regulatory action, the prohibition would 

start three months later than under the 

proposed regulatory action, and thus the 

compliance timeframe would be two 

years and three months longer than 

under the proposed regulatory action 

described in Unit V.A.4. (description of 

disposal for the purposes of this 

rulemaking is provided in Unit 

III.B.2.d.). Under the primary alternative 

regulatory action, the prohibition 

described in this unit would take effect 

in three years for domestic 

manufacturers, processors, and 


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industrial and commercial users 

disposing of TCE to wastewater, 

including disposing of TCE-containing 

wastewater to industrial pre-treatment, 

industrial treatment, or publicly owned 

treatment works. EPA recognizes there 

may be challenges in identifying and 

implementing an alternative disposal 

process separate from disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works. EPA requests comment on 

whether the three-year alternative 

timeline would be practicable or 

whether additional time is needed, for 

example, for a regulated entity to 

implement a change to their wastewater 

collection, treatment, or disposal 

processes or infrastructure, and what 

those alternative disposal methods may 

be. 

2. Workplace Chemical Protection 

Program for Certain Conditions of Use 

As in the proposed regulatory action 

described in Unit V.A.1., EPA’s primary 

alternative regulatory action would 

include a WCPP as a requirement, 

which would encompass an ECEL as 

well as dermal requirements to reduce 

inhalation and dermal exposures to 

TCE. However, the WCPP under the 

primary alternative regulatory action 

would include an ECEL based on a 

different health endpoint, 

immunotoxicity, as further discussed in 

this unit. The WCPP would be in place 

until the prohibition compliance date 

for those conditions of use of TCE that 

would continue for longer than one year 

after publication of the final rule, which 

would be: manufacturing (including 

import); processing: as a reactant/ 

intermediate; incorporation into 

formulation, mixture or reaction 

product; repackaging; recycling; 

industrial and commercial use: as a 

solvent for open-top batch vapor 

degreasing; industrial and commercial 

use as a solvent for closed-loop batch 

vapor degreasing; and industrial and 

commercial use as a 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. 

As discussed in Unit V.A.2., and for 

the reasons described in Unit V., EPA 

does not believe that long-term 

implementation of the WCPP would be 

a feasible means of addressing 

unreasonable risk indefinitely and that 

prohibition of the affected COUs would 

ultimately be necessary to eliminate the 

unreasonable risk. Under the primary 

alternative regulatory action, the WCPP 

for several conditions of use of TCE 

would reduce to the extent possible the 

unreasonable risk during the time 

period before a prohibition would 

become effective. 

For the primary alternative regulatory 

action, the WCPP would encompass an 

ECEL based on immunotoxicity, 

following the associated 

implementation requirements discussed 

in Unit V.A.2., in addition to longer 

timeframes described in this unit. EPA’s 

primary alternative regulatory action 

includes an ECEL of 0.0040 ppm (0.021 

mg/m3) as an eight-hour TWA, which is 

based on the chronic non-cancer 

occupational HEC for autoimmunity 

(Ref. 14). As discussed in Unit VI.A., 

among the adverse health effects, the 

drivers for EPA’s revised unreasonable 

risk determination for TCE under TSCA 

were identified as cancer, 

immunotoxicity, acute 

immunosuppression and chronic 

autoimmunity from inhalation and 

dermal exposures (Ref. 2). Therefore, 

reducing the remaining exposures to or 

below the ECEL of 0.0040 ppm would 

address 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 eighthour 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 Unit III.B.2., but also 

effects resulting from acute non-cancer 

exposure (immunosuppression) and 

cancer. Associated with the ECEL of 

0.0040 ppm, under the alternative 

regulatory action, EPA would establish 

an ECEL action level at half of the eighthour ECEL, or 0.002 ppm as an eighthour time-weighted average. 

EPA believes that longer timeframes 

may facilitate compliance; therefore, the 

primary alternative regulatory action 

would provide longer timeframes for 

implementation of a WCPP than the 

proposed regulatory action. With a 

compliance timeframe that would be six 

months later than in the proposed 

regulatory action, the compliance 

timeframe for the WCPP under the 

primary alternative regulatory action 

would be extended as follows: regulated 

entities would establish initial exposure 

monitoring according to the process 

outlined in Unit V.A.2.ii. within 12 

months (in contrast to six months in the 

proposed regulatory action described in 

Unit V.A.2.ii.) and proceed accordingly, 

based on the outcome of the initial 

monitoring. EPA requests comment on 

the ability of regulated entities to 

conduct initial monitoring within 12 

months, anticipated timeframes for any 

procedural adjustments needed to 

comply with the requirements, and the 

extent to which this option could result 

in additional exposure, compared to the 

proposed regulatory option as described 

in Unit V.A. Overall, EPA requests 

comment on the practicability of the 

timeframes outlined in this unit, when 

compared to the timeframes identified 

for the proposed regulatory action in 

Unit V.A. EPA requests comment on 

whether any elements of the primary 

alternative regulatory action described 

in this unit should be considered as 

EPA develops the final regulatory 

action, e.g., whether EPA should 

consider the timeframes for 

implementation of a WCPP presented in 

this primary alternative regulatory 

action and the ECEL value presented in 

the proposed regulatory action. 

EPA does not have sufficient 

information as to whether the 

conditions of use that would continue 

for longer than one year under the 

primary alternative regulatory action 

listed in this unit could meet 

requirements of a WCPP for TCE, 

including an ECEL of 0.0040 ppm for 

TCE. Therefore, EPA requests comment 

on the existing practices (e.g., 

engineering controls, administrative 

controls, PPE) involving TCE use in 

these conditions of use, as to whether 

activities may take place in closed 

systems and the degree to which users 

of TCE in these sectors could 

successfully implement an ECEL of 

0.0040 ppm, dermal protection, and 

ancillary requirements, described in 

Unit V.A.2., until the prohibitions 

would become effective, including for 

the manufacturing, processing, and 

distribution in commerce that account 

for the supply chain. 

3. TSCA Section 6(g) Exemptions 

Under TSCA section 6(g)(1), EPA may 

grant an exemption from a requirement 

of a TSCA section 6(a) rule for uses that 

are critical or essential. Based on 

discussions with and information 

provided by industry stakeholders and 

consultation with other Federal 

agencies, EPA has analyzed the need for 

two different exemptions, described in 

the proposed regulatory action 

discussed in Units I.A.3.a. and b., and 

would grant both with a longer time 

limit if the primary alternative 

regulatory action described in this 

NPRM is adopted in the final rule. 

Furthermore, under the primary 

alternative regulatory action, EPA has 

analyzed the need for additional 

exemptions for essential uses of opentop and closed-loop batch vapor 

degreasing for aerospace use (including 


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for rayon fabric scouring for rocket 

booster nozzle production) as well as 

narrow tubing used in medical devices, 

and EPA would provide the additional 

exemptions if the primary alternative 

regulatory action described in this 

NPRM is adopted in the final rule. (EPA 

notes that the use of TCE for vapor 

degreasing narrow tubing used in 

medical devices is not excluded by 

TSCA section (3)(2)(B)(vi) because TCE 

is not intended to become part of the 

medical device that incorporates the 

narrow tubing). This unit presents the 

results of the analysis for the requested 

exemption for industrial and 

commercial use of TCE in vapor 

degreasing, as well as the time limits 

indicated under the primary alternative 

regulatory action. 

a. Primary Alternative Analysis of the 

Need for TSCA Section 6(g)(1) 

Exemptions for Uses of TCE That Are 

Critical or Essential 

i. Analysis of the Need for a TSCA 

Section 6(g)(1)(B) Exemption for 

Industrial and Commercial Use of TCE 

in Vapor Degreasing for Essential 

Aerospace Parts and Components 

EPA has conducted an analysis of the 

application of this rulemaking to the 

industrial and commercial use of TCE in 

vapor degreasing and found that a TSCA 

section 6(g) exemption may be 

warranted for certain aerospace parts 

and components if the primary 

alternative regulatory action considered 

by EPA is adopted, in its entirety or in 

relevant part, in the final rule. 

EPA received a request for a TSCA 

section 6(g) exemption from prohibition 

for the use of TCE in vapor degreasing 

of aerospace parts from a manufacturer 

of commercial jetliners and defense, 

space, and security systems (Refs. 60 

and 61). As the requester describes, they 

manufacture and procure these parts 

and have identified that TCE vapor 

degreasing is necessary due to technical 

challenges with other substitute 

chemicals or alternative methods. 

The requester has spent many years 

developing, qualifying, and 

implementing alternative materials and 

processes to replace TCE vapor 

degreasing with aqueous cleaning where 

technically viable. According to the 

requester, while the transition to 

aqueous cleaning has been successful 

for many detail parts (e.g., stringers, 

spars, seat tracks, brackets, etc.), 

substitutes and alternative processes do 

not meet the technical specifications 

required to clean certain complex 

aerospace parts, specifically, gaseous 

oxygen tubing systems, non-oxygen 

tubing, as well as honeycomb core and 

rotorcraft mechanical systems. The 

requester notes the ongoing research 

and development activities over the 

years for the TCE vapor degreasing uses 

without viable alternatives, and 

highlights that a potential replacement 

technology has been identified for vapor 

degreasing oxygen and non-oxygen 

tubing systems. However, for the 

honeycomb core and rotorcraft 

mechanical systems parts, the requestor 

explains the continued challenge to 

identify a replacement solvent due to 

entrapment issues (i.e., a solvent carried 

out of a degreaser that adheres to or is 

entrapped in the part being removed) 

and processing concerns. 

The requester notes that an adequate 

transition period for this technically 

challenging aerospace use requires 

substantial investment and time to 

develop viable alternatives. The 

requester is currently in the process of 

identifying a replacement solvent that 

can adequately clean, cause no harm to 

parts, and is not an equally toxic 

material to TCE. Based on the submitted 

request, conversion from vapor 

degreasing to aqueous cleaning is a 

capital-intensive investment that the 

requester expects would require several 

years to plan, permit, construct, and 

install. Additionally, the requester notes 

that the aerospace industry needs to 

ensure that aerospace parts meet DOD 

and other Federal Aviation 

Administration (FAA) specifications to 

ensure safety of flight. For example, in 

order to replace the chemical with an 

alternative, the requester notes that they 

must identify, test, and select an 

alternative that meets technical 

requirements derived from FAA 

mandated standards for a typical part 

used in a commercial aircraft, such as 

specifications for specific gravity 

(ASTM D 792), Water Absorption 

(ASTM D 750), and other test 

requirements, which may be a lengthy 

process (Ref. 62). According to the 

information submitted, certification 

with FAA could take at least nine 

months for individual parts of 

components or up to several years for 

major subsystems or complete aircraft 

(Ref. 62). The requester also notes that 

while they do not know the extent that 

their supply chain has transitioned 

away from use of TCE in vapor 

degreasing, TCE has been used in vapor 

degreasing to meet required levels of 

cleanliness of certain supplied parts by 

long-standing design specifications that 

are incorporated into contracts of a 

complex supply chain. The requester 

also told EPA the suppliers are not 

required to inform the requester of the 

process they use to clean parts that the 

supplier provides to the requester, and 

the requester therefore may not know 

which solvent a supplier has selected 

for vapor degreasing or what factors 

were considered when selecting 

cleaning systems. According to the 

requester, material declarations and 

auditing processes to validate usage may 

be burdensome, considering that a large 

portion of the requester’s supply chain 

includes small suppliers. Due to the 

concerns raised with transitioning to 

aqueous cleaning or another new 

cleaning method, the requester has 

requested that EPA exempt use of TCE 

in vapor degreasing of aerospace parts 

for 10 years. 

As discussed in this unit, substitute 

chemicals for vapor degreasing of 

aerospace parts may not be available at 

this time for meeting the cleanliness 

standards of certain parts as required by 

DOD and FAA specifications or other 

specifications included in existing 

contracts within the supply chain such 

that significant disruption to national 

security and critical infrastructure 

would occur without a longer timeframe 

for transition to an alternative. More 

time is needed for companies to make 

the capital-intensive transition from 

TCE vapor degreasing to aqueous 

cleaning for those parts that can be 

cleaned using the aqueous method. In 

addition, the requester states that they 

are continuing to work towards 

identifying a replacement solvent that is 

able to adequately clean complex 

machining parts and actuation systems 

parts without harming them and that is 

not a regrettable substitution. Therefore, 

EPA has preliminarily determined that 

if the use of TCE for vapor degreasing 

were not available in the near term for 

aerospace parts, or if industry could not 

meet the requirements of the prohibition 

considered as the proposed regulatory 

action, compliance with such 

requirement could significantly disrupt 

national security and critical 

infrastructure. In addition, due to 

availability concerns, EPA has 

preliminarily determined that a ban on 

the manufacture, processing, and 

distribution in commerce of TCE for 

vapor degreasing of aerospace parts 

could also significantly disrupt national 

security and critical infrastructure. A 

prohibition on the use of TCE for vapor 

degreasing of aerospace parts could 

negatively affect DOD’s capability and 

readiness, which includes the ability to 

adequately maintain aircraft. Such a 

prohibition could also negatively affect 

the maintenance of civilian aircraft and 

potentially have impacts on the safety of 

civilian flight. 

Similarly, EPA is aware of a highly 

specific use of vapor degreasing for 


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aerospace components as part of 

production of booster rocket nozzles for 

national security or critical 

infrastructure uses (Ref. 43). In the 

production of booster rocket nozzles, 

TCE is used in vapor degreasing as a 

solvent in rayon fabric scouring, an 

intensive cleaning process to remove 

contaminants. Cleaning is a critical step 

of this process; if contaminants are not 

sufficiently removed in the scouring 

stage, the fabric will be degraded during 

the chemical reaction that occurs during 

carbonization which could result in 

failure of the nozzle during a launch 

and catastrophic effects for the rockets. 

A Federal agency involved in this use, 

specifically NASA, has attempted at 

length to identify an alternative to TCE 

in vapor degreasing; while NASA had 

preliminarily identified an alternative 

solvent, the manufacturer of the 

substitute chemical announced they 

would be voluntarily ceasing 

production (Ref. 63), making this 

alternative solvent no longer viable. 

NASA has restarted the identification 

and qualification of a non-TCE cleaning 

method. While aqueous cleaning has 

been explored as an alternative method 

of rayon fabric scouring, it is not a 

viable alternative as the rayon fiber is 

hydrophilic and water can cause 

damage to the fiber itself, impacting its 

ablation performance (Ref. 43). 

Currently, substitutes and alternative 

processes do not meet the technical 

specifications required to clean the 

rayon fabric in order to safely produce 

and launch rockets that are important 

for national security or critical 

infrastructure. NASA has provided to 

EPA an estimated timeline for the 

identification and replacement of TCE 

in the vapor degreasing of this 

component. The replacement of TCE 

involves intense testing as it is part of 

spaceflight, notably a new process 

would have to undergo various rounds 

of testing culminating in a full-scale 

static motor test using a booster nozzle 

manufactured with an alternative 

cleaning solvent. For NASA specifically, 

the first opportunity to conduct a fullscale static motor test with a booster 

nozzle produced using a non-TCE 

alternative would be 2027; before that is 

planned to occur, NASA has launches 

planned with eight booster rockets, 

which cannot proceed unless all 

components are safely produced. 

Therefore, EPA has preliminarily 

determined that if TCE was not 

available for this sub-use of closed-loop 

batch vapor degreasing for this 

aerospace component, there would be a 

significant, disruptive impact on 

national security and critical 

infrastructure. In addition, due to 

availability concerns, EPA has 

preliminarily determined that a ban on 

the manufacture, processing, and 

distribution in commerce of TCE for 

vapor degreasing of aerospace parts 

could also significantly disrupt national 

security and critical infrastructure. 

ii. Analysis of the Need for a TSCA 

Section 6(g)(1)(A) Exemption for 

Industrial and Commercial Use of TCE 

in Closed-Loop and Open-Top Batch 

Vapor Degreasing for Narrow Tubing 

Used in Medical Devices 

EPA also finds that a TSCA section 

6(g)(1)(A) exemption may be warranted 

for vapor degreasing of narrow metal 

tubing used in medical devices if the 

primary alternative regulatory action 

considered by EPA is adopted in the 

final rule. According to a manufacturer 

of metal tubing for medical devices (Ref. 

64), TCE is the only solvent that they 

have found that effectively removes all 

lubricants from their tubing products, 

allowing them to meet the stringent 

cleanliness standards for medical 

devices. 

Information provided to EPA from the 

tubing manufacturer indicates that their 

tubing products consist of over 20 

different alloys processed with more 

than 25 different lubricants, for use 

primarily in the medical industry. The 

tubing is incorporated into devices used 

in the body for diagnostic and surgical 

procedures as well as permanent 

implants for orthopedic and 

cardiovascular applications. The tubing 

produced by the manufacturer ranges in 

diameter from 0.005′′ to 0.625′′, and both 

the inner and outer diameters of the 

tubing must be degreased at various 

points in the manufacturing process 

(Ref. 64). 

According to this manufacturer, the 

use of specialty lubricants in the 

drawing and annealing processes create 

unique degreasing demands for narrow 

tube manufacturers and TCE has 

historically been the industry standard 

for effective removal of these lubricants. 

Cleanliness is paramount, as even the 

slightest degreasing failure may cause 

corrosion, which could result in a 

critical failure of an implantable 

medical device. Alternative solvents 

such as methylene chloride or 1- 

bromopropane are not feasible 

alternatives for a variety of reasons, 

including that they do not always 

achieve the required cleanliness 

standards, could result in a facility 

exceeding emission caps under the 

Clean Air Act, and are also in the 

process of being regulated by EPA under 

TSCA. Other alternative chemicals have 

been explored by the manufacturer, 

such as parachlorobenzotrifluoride, 

which is not a hazardous air pollutant 

under the Clean Air Act. While 

promising, this solvent could not 

remove some of the manufacturer’s 

lubricants and specialty coatings, thus 

not meeting the customer’s cleanliness 

standard. This alternative is also 

flammable, which would require 

additional equipment design and 

infrastructure to use safely. 

The information provided by this 

manufacturer of tubing for use in 

medical devices regarding TCE vapor 

degreasing is consistent with the 

information provided by the aerospace 

industry regarding challenges with 

finding a replacement for TCE in vapor 

degreasing of tubing. It is also consistent 

with information provided to EPA 

during the public comment period for 

EPA’s 2017 proposal on TCE in vapor 

degreasing (82 FR 7432, January 19, 

2017). A commenter on that proposal 

indicated that aqueous cleaners did not 

effectively remove most of the materials 

in their lubrication system, so effective 

lubricants and coating systems would 

need to be developed that are 

compatible with aqueous cleaners (Ref. 

65). Experiments with other lubricants 

were not successful, the commenter 

found that lubricants that could be 

effectively aqueous degreased were less 

effective at lubricating, requiring more 

drawing steps as well as more cleaning 

steps. Further, according to this 

commenter, aqueous cleaning requires 

large, heated water tanks and hot air 

drying chambers, increasing energy use 

and industrial effluent volumes. 

In addition, EPA did not impose 

additional Clean Air Act emission 

reductions on aerospace manufacturing 

and maintenance facilities or on 

facilities manufacturing narrow tubing 

in 2007, recognizing the unique nature 

of the vapor degreasing done by these 

industries. In the 2007 final rule, EPA 

found that the level of control called for 

by the 1994 National Emission Standard 

for Halogenated Solvent Cleaning for 

aerospace manufacturing and 

maintenance and narrow tube 

manufacturing facilities reduced 

hazardous air pollutant emissions to 

levels that presented an acceptable level 

of risk, protected public health with an 

ample margin of safety, and prevented 

any adverse environmental effects (Ref. 

66). As noted in the 2007 final rule, the 

finding regarding an ‘‘ample margin of 

safety’’ was based on a consideration of 

the additional costs of further control as 

represented by compliance with 

emissions limits adapted for these 

industry sectors, considering 

availability of technology, costs and 

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EPA further notes that the term ‘‘narrow 

tube’’ as used in the 2007 final rule was 

tubing with a portion of the outside 

diameter being a quarter of an inch or 

less, which is different from the 

diameters provided by the narrow tube 

manufacturer (Ref. 64). 

EPA acknowledges the importance of 

properly cleaned narrow tubing used in 

medical devices. The failure of a 

medical device used in a medical or 

surgical procedure, or implanted in the 

body, can have immediate and 

significant negative impacts on human 

health. Further, a complete prohibition 

on the use of TCE for vapor degreasing 

in the near term could result in 

shortages of narrow tubing for use in 

such medical devices, which would also 

have significant negative impacts on 

human health. Therefore, EPA requests 

comment on the extent to which the use 

of TCE for vapor degreasing of narrow 

tubing is a critical use for which no 

technically and economically feasible 

safer alternative is available. In 

addition, due to availability concerns, a 

ban on the manufacture, processing, and 

distribution in commerce of TCE for 

vapor degreasing of narrow tubing used 

in medical devices could significantly 

disrupt a critical use for which no 

technically and economically feasible 

safer alternative is available. 

iii. Analysis of the Need for a TSCA 

Section 6(g)(1)(A) Exemption for 

Industrial and Commercial Use of TCE 

as a Processing Aid for Specialty 

Polymeric Microporous Sheet Materials 

EPA has conducted an analysis of the 

application of this rulemaking to the 

industrial and commercial use of TCE as 

a processing aid and preliminarily 

found that a TSCA section 6(g)(1)(A) 

exemption may be warranted for certain 

industrial and commercial purposes if 

the primary alternative regulatory action 

considered by EPA is adopted, in its 

entirety or in relevant part, in the final 

rule. As part of industry stakeholder 

engagement, EPA was made aware that 

at least one U.S. materials manufacturer 

relies on TCE to manufacture a specialty 

microporous sheet material. This 

company has requested an exemption 

under TSCA section 6(g) for the 

continued use of TCE for this purpose 

(Ref. 67). 

As the requestor describes, specialty 

polymeric microporous sheet materials 

are fundamental components in the 

production of critical or essential 

products. EPA preliminarily agrees that 

certain applications of these specialty 

polymeric microporous sheet materials 

are critical and essential uses for which 

no technically and economically 

feasible safer alternative is available. 

This exemption on processing TCE 

would be limited to processing for 

applications of the specialty polymeric 

microporous sheet materials that are 

critical and essential, specifically; 

driver’s licenses and identification cards 

of U.S. states and territories; passports 

(including U.S. passports and epassports); labels for chemical drums, 

complex filtration elements and 

cartridges (such as for oil/water and 

bilge water separations); and for use in 

membranes in energy recovery 

ventilators. Any application of the 

specialty polymeric microporous sheet 

materials for uses not listed above 

would not be covered under this 

exemption. 

EPA believes that these uses would 

preliminarily also qualify for an 

exemption under TSCA section 

6(g)(1)(B). These critical and essential 

products are also important for the 

national economy, national security, 

and critical infrastructure and EPA 

preliminarily agrees that compliance 

with the prohibition within the 

timeframes proposed would be 

disruptive. The proper identification of 

individuals is important for maintaining 

national security and critical 

infrastructure. Systems such as travel, 

healthcare, and law are all reliant on 

identification. Further, the proper 

labeling of chemicals is important for 

protecting critical infrastructure. 

Similarly, complex filtration elements 

and cartridges (such as for oil/water and 

bilge water separations) and membranes 

in energy recovery ventilation are 

essential for the operations of critical 

infrastructure. 

Each of these products includes the 

use of TCE in their development. The 

requester described the specific use of 

TCE as a ‘‘process solvent’’ during the 

manufacturing of a ‘‘unique polymeric 

microporous sheet material’’ (Ref. 67). 

The company makes the microporous 

sheet material using process oil (white 

mineral oil) during the extrusion 

process in order to form a thin plastic 

sheet containing 55–60% process oil by 

weight. The process oil is then removed 

from the plastic sheet, which requires 

the use of a solvent (i.e., TCE) to rapidly 

extract the process oil and leave behind 

the desired microporosity for the 

material. The requestor describes how 

specific microporosity is important for 

performance of the material. Once the 

solvent has removed the oil from the 

sheet, the solvent must be evaporated to 

remove it from the sheet; postevaporation, the separator must leave 

behind the desired microporosity 

crucial to the performance of the 

material. Finally, the extracted oil and 

much of the TCE is captured and reused 

in the extraction process. TCE that is not 

captured and reused is released from a 

discharge stack; the requestor describes 

that the air released contains no more 

than 10 ppm of TCE. 

The requestor describes this 

manufacturing process as wellestablished and reliant on TCE as a 

high-performance process solvent that 

provides a unique combination of 

chemical properties (e.g., nonflammability, rapid extrusion of process 

oil, compatibility with process 

equipment, etc.). The requestor 

describes how this unique combination 

of properties facilitate the controlled 

removal of process oil in the production 

of the specialty polymeric microporous 

sheet material, resulting in the specific 

microporosity important for the 

performance of the material. 

The requester has provided some 

details to EPA on its efforts to reduce 

worker exposure to TCE. The exposure 

mitigation program includes a separate 

area under negative pressure for TCE 

processing and use of PPE as necessary 

to comply with the OSHA PEL for TCE 

(Refs. 67, 10). While EPA’s proposed 

ECEL is much lower than the OSHA 

PEL, EPA expects the requester to make 

appropriate changes to its worker 

exposure mitigation program to comply 

with the WCPP and attempt to meet the 

ECEL to the extent possible for the 

duration of this exemption. 

According to the requester, there are 

several properties that make TCE 

uniquely suitable for use in the 

manufacture of the specialty 

microporous sheet material. The key 

properties described by the requester 

include TCE’s rapid extraction of 

process oil, the ease by which TCE is 

distilled from the process oil for 

recovery and reuse, and its vapor 

pressure, which both allows for 

evaporation and permits condensation 

from the atmosphere. TCE is also nonflammable. The requester evaluated 

more than a dozen potential alternatives 

that could be compatible with their 

process for manufacturing specialty 

polymeric microporous sheet materials, 

including hexane, trans-1,2- 

dichloroethylene, perchloroethylene, 

and 1-bromopropane. Many of these 

substitutes were found to be less 

effective than TCE at extracting process 

oils, while some were not as easily 

recovered and reused. Even the more 

promising solvents, such as 

perchloroethylene, were not drop-in 

replacements and would, according to 

the requester, require expensive 

equipment modifications and a multiyear approval process. Many of the 

potential substitute chemicals would 

need to be blended with an HFC that is 


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being phased out, or the chemical itself 

is being phased out due to concern over 

PFAS or due to high Global Warming 

Potential. In addition to these 

challenges, the requestor describes how 

any blend would be a challenging 

substitute because the different 

chemicals in the blend evaporate at 

different rates and could become 

flammable during this process. The 

requester emphasized that it is using 

modeling to seek out potential 

alternatives, but that further study is 

required and that there is no other 

chemical alternative that is suitable or 

available to replace TCE in this process. 

Based on the requester’s submission and 

EPA’s general understanding of the 

manufacturing process for the specialty 

microporous sheet material, EPA 

believes that there are no feasible 

alternatives to TCE available at present. 

While the requester did not describe 

a time limit for the exemption, EPA has 

identified a 15-year time-limited TSCA 

section 6(g) exemption under the 

alternative regulatory action. EPA 

believes that a 15-year exemption from 

the prohibition on the industrial and 

commercial use of TCE as a processing 

aid, specific to the manufacturing of 

specialty microporous sheet materials, 

would be reasonable because it would 

be sufficient to provide EPA with an 

updated analysis of any technically 

feasible alternative, the supply chain of 

the U.S. materials industry, as well as 

global innovation and production in 

high-technology products. Under TSCA 

section 6(g), EPA can consider revisiting 

or extending time-limited exemptions 

by rulemaking until a safer, feasible 

alternative becomes available. EPA 

requests comment on whether 15 years 

is an appropriate timeframe for the 

proposed TSCA section 6(g) exemption 

for industrial and commercial use of 

TCE as a processing aid for specialty 

polymeric microporous sheet materials. 

b. Primary Alternative Exemptions for 

Uses of TCE That Are Critical or 

Essential 

i. Primary Alternative 15-Year 

Exemption for Industrial and 

Commercial Use as a Processing Aid for 

Battery Separator Manufacturing (LeadAcid and Lithium Battery Separators) 

As part of the primary alternative 

regulatory action, based on the analysis 

in Unit V.A.3.a.i., EPA would grant a 

15-year exemption from the prohibition 

on TCE for the industrial and 

commercial use as a processing aid for 

battery separator manufacturing. The 

primary alternative regulatory action 

differs from the proposed regulatory 

action in that it extends the compliance 

date for the exemption by five years, 

allowing a longer timeframe for 

stakeholders to continue the use until 

its prohibition, in recognition of the 

challenge to transition to an alternative 

chemical or process, further discussed 

in Unit V.B. The conditions for the 

exemption under the primary 

alternative regulatory action would be: 

(1) The use of TCE would be limited to 

use as a processing aid for battery 

separator manufacturing to supply the 

essential battery components to 

continue to support the national 

economy, national security, and critical 

infrastructure; (2) this specific industrial 

and commercial use of TCE as a 

processing aid must be conducted at 

industrial facilities already using TCE to 

supply the lithium ion or lead acid 

battery components; and (3) Industry 

stakeholders who use TCE as a 

processing aid for battery separator 

manufacturing and entities that 

manufacture (including import), 

process, and distribute in commerce 

TCE to be available as a processing aid 

must comply with the WCPP 

requirements described in Unit V.B.2., 

including meeting the ECEL to the 

extent possible until the prohibition 

compliance date. 

ii. Primary Alternative 30-Year 

Exemption for Industrial and 

Commercial Use of TCE in Laboratory 

Use for Essential Laboratory Activities 

As part of the primary alternative 

regulatory action, based on the analysis 

discussed in Unit V.A.3.a.iii., there 

would be a 30-year exemption from the 

prohibition on TCE in other 

miscellaneous industrial and 

commercial use of TCE in laboratory use 

for essential laboratory activities. The 

primary alternative regulatory action 

differs from the proposed regulatory 

action in that it shortens the compliance 

date by 20 years. The conditions for the 

primary alternative proposed exemption 

are: (1) The use of TCE is limited to uses 

in an industrial or commercial 

laboratory for essential laboratory 

activities, including chemical analysis, 

chemical synthesis, extracting and 

purifying other chemicals, dissolving 

other substances, with the exclusion of 

laboratory testing for asphalt; and (2) 

Stakeholders who use TCE in laboratory 

settings and stakeholders who 

manufacture (including import), 

process, and distribute in commerce 

TCE to be available as a laboratory 

chemical must comply with the WCPP 

requirements described in Unit V.B.2., 

including meeting the ECEL to the 

extent possible until the prohibition 

compliance date. 

iii. Primary Alternative Seven-Year 

Exemption for Industrial and 

Commercial Use of TCE in Batch Vapor 

Degreasing for Essential Aerospace Parts 

and Components and Narrow Tubing 

Used in Medical Devices 

For the reasons discussed in this unit, 

EPA would grant a seven-year 

exemption from the prohibition as part 

of the primary alternative regulatory 

action for the industrial and commercial 

use of TCE in batch vapor degreasing for 

essential aerospace parts and 

components and narrow tubing used in 

medical devices. While one requester 

suggested that an appropriate length of 

time for an exemption would be 10 

years, and another did not specify, EPA 

notes that a prohibition on vapor 

degreasing with TCE for all uses was 

proposed in 2017 (Ref. 68). While that 

proposal was withdrawn pending the 

completion of a risk evaluation for TCE 

under amended TSCA, which included 

the evaluation of the vapor degreasing 

conditions of use, EPA expects that 

certain stakeholders have made 

significant progress on substitutes since 

then in anticipation of similar 

restrictions on TCE under amended 

TSCA. For instance, EPA is aware that 

many users have transitioned to a 

substitute for TCE where possible or are 

planning for technologically feasible 

adjustments (Refs. 32, 43). 

The conditions for the exemption 

would be: (1) TCE could only be used 

for batch vapor degreasing of aerospace 

parts or components (including rayon 

fabric) where other alternatives present 

technical feasibility or cleaning 

performance challenges to meet 

specifications from other Federal 

agencies or other long-standing design 

specifications that are included in 

existing contracts, or for batch vapor 

degreasing of narrow tubing used in 

medical devices; and (2) Industry 

stakeholders who use TCE for batch 

vapor degreasing of aerospace parts or 

components or narrow tubing used in 

medical devices and entities that 

manufacture (including import), 

process, and distribute in commerce 

TCE to be available for TCE vapor 

degreasing would comply with the 

WCPP requirements described in Unit 

V.B.2. to the extent possible until the 

prohibition compliance date. EPA 

requests comments on all aspects of the 

exemption request and the exemption in 

the primary alternative regulatory action 

from the prohibition on use of TCE in 

batch vapor degreasing, including 

whether compliance with the WCPP 

should also be required during the 

period of the exemption. Additionally, 

EPA is soliciting comment on whether 


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it should specify the type of batch vapor 

degreasing operation, such as open-top 

or closed loop batch vapor degreasing, 

that would be exempt from prohibition 

as part of the primary alternative 

regulatory action for the industrial and 

commercial use of TCE in batch vapor 

degreasing for essential aerospace parts 

and components and narrow tubing for 

medical devices. EPA also requests 

comment whether it should consider 

different exemption timeframes for 

different types of vapor degreasing 

operations. 

iv. Primary Alternative 15-Year TSCA 

Section 6(G)(1)(A) Exemption for 

Industrial and Commercial Use of TCE 

as a Processing Aid for Specialty 

Polymeric Microporous Sheet Materials 

As part of the primary alternative 

regulatory action, based on the analysis 

in Unit V.A.3.c., EPA would grant a 15- 

year exemption from the prohibition on 

TCE for the industrial and commercial 

use as a processing aid for specialty 

polymeric microporous sheet material 

manufacturing. Under the primary 

alternative regulatory action, in 

accordance with TSCA section 6(g)(4), 

the conditions for the exemption that 

EPA believes are necessary to protect 

health and the environment would be: 

(1) The use of TCE would be limited to 

use as a processing aid for the 

manufacturing of specialty polymeric 

microporous sheet materials; and (2) 

Stakeholders who use TCE as a 

processing aid for the manufacturing of 

specialty polymeric microporous sheet 

materials and entities that manufacture 

(including import), process, and 

distribute in commerce TCE to be 

available as a processing aid must 

comply with the WCPP requirements 

described in Unit V.B.2., including 

meeting the ECEL to the extent possible 

until the prohibition compliance date. 

EPA requests comments on all aspects 

of the exemption in the primary 

alternative regulatory action from the 

prohibition on industrial and 

commercial use of TCE as a processing 

aid, specific to the manufacturing of 

specialty microporous sheet materials, 

including whether compliance with the 

WCPP should also be required during 

the period of the exemption. EPA also 

requests comment on whether 15 years 

would be an appropriate timeframe for 

a TSCA section 6(g)(1)(A) exemption for 

this use. 

C. Overview of Conditions of Use and 

Proposed Regulatory Action and 

Primary Alternative Regulatory Action 

Table 2 is a side-by-side depiction of 

the proposed regulatory action with the 

primary alternative action for each 

condition of use identified as driving 

the unreasonable risk (Ref. 2). The 

purpose of this table is to succinctly 

convey to the public the major 

differences between the proposed 

regulatory action and the primary 

alternative regulatory action; as such the 

actions in each column are truncated 

and do not necessarily reflect all the 

details of the proposed and alternative 

regulatory action, including differences 

in timeframes. EPA notes that ‘‘prohibit 

+ WCPP’’ listed in the table indicates 

that a condition of use would be 

prohibited, but in the time before the 

prohibition goes into effect, there would 

be a WCPP. For the proposed action, the 

WCPP would include an ECEL of 0.0011 

ppm based on the fetal cardiac defects 

endpoint so that the developing fetus is 

best protected (see Unit V.A.), especially 

for the sensitive PESS group of older 

pregnant workers and ONUs (the group 

identified as most susceptible to fetal 

cardiac defects), while under the 

primary alternative regulatory action, 

the WCPP would include an ECEL of 

0.0040 ppm based on the 

immunotoxicity endpoint (see Unit 

V.B.). The rationale for these differences 

is detailed in Unit VI.A.1. 

The proposed and alternative 

regulatory actions are described more 

fully in Units V.A. and B. 

TABLE 2—OVERVIEW OF PROPOSED REGULATORY ACTION AND ALTERNATIVE REGULATORY ACTION BY CONDITIONS OF

USE

Condition of use 

Action 

Proposed regulatory action 1 Primary alternative action 

Manufacturing: domestic manufacture ............... Prohibit + WCPP includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit + WCPP includes an ECEL of 0.0040 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on immunotoxicity. 

Manufacturing: import ......................................... Prohibit + WCPP includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit + WCPP includes an ECEL of 0.0040 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on immunotoxicity. 

Processing: processing as a reactant/intermediate.Prohibit; includes a phaseout of TCE for processing as an intermediate for the manufacture of HFC–134a + WCPP includes an 

ECEL of 0.0011 ppm for inhalation exposures to TCE as an eight-hour TWA based 

on developmental toxicity.

Prohibit; includes a phaseout of TCE for processing as an intermediate for the manufacture of HFC–134a + WCPP includes an 

ECEL of 0.0040 ppm for inhalation exposures to TCE as an eight-hour TWA based 

on immunotoxicity. 

Processing: incorporation into a formulation, 

mixture, or reaction product.

Prohibit + WCPP includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit + WCPP includes an ECEL of 0.0040 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on immunotoxicity. 

Processing: incorporation into articles ............... Prohibit ............................................................. Prohibit. 

Processing: repackaging .................................... Prohibit + WCPP includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit + WCPP includes an ECEL of 0.0040 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on immunotoxicity. 

Processing: recycling ......................................... Prohibit + WCPP includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit + WCPP includes an ECEL of 0.0040 

ppm for inhalation exposures to TCE as an 

eight-hour TWA based on immunotoxicity. 


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TABLE 2—OVERVIEW OF PROPOSED REGULATORY ACTION AND ALTERNATIVE REGULATORY ACTION BY CONDITIONS OF

USE—Continued 

Condition of use 

Action 

Proposed regulatory action 1 Primary alternative action 

Industrial and commercial use as a solvent for 

open-top batch vapor degreasing.

Prohibit ............................................................. Prohibit; includes a TSCA section 6(g) exemption for the industrial and commercial 

use as solvent for open-top batch vapor 

degreasing for essential aerospace use + 

WCPP includes an ECEL of 0.0040 ppm for 

inhalation exposures to TCE as an eighthour TWA based on immunotoxicity. 

Industrial and commercial use as a solvent for 

closed-loop batch vapor degreasing.

Prohibit; includes a phaseout of TCE for industrial and commercial use as a solvent 

for closed loop batch vapor degreasing for 

rayon fabric scouring for end use rocket 

booster nozzle production by Federal Agencies and their contractors and a TSCA section 6(g) exemption for industrial and commercial use as a solvent for closed loop 

batch vapor degreasing necessary for 

human-rated rocket engine cleaning by 

NASA and its contractors+ WCPP for one 

sub-use includes an ECEL of 0.0011 ppm 

for inhalation exposures to TCE as an 

eight-hour TWA based on developmental 

toxicity.

Prohibit; includes a TSCA section 6(g) exemption for the industrial and commercial 

use as solvent for closed-loop batch vapor 

degreasing for essential aerospace use and 

medical tubing + WCPP includes an ECEL 

of 0.0040 ppm for inhalation exposures to 

TCE as an eight-hour TWA based on 

immunotoxicity. 

Industrial and commercial use as a solvent for 

in-line conveyorized vapor degreasing.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a solvent for 

in-line web cleaner vapor degreasing.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a solvent for 

cold cleaning.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a solvent for 

aerosol spray degreaser/cleaner and mold release.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a lubricant 

and grease in tap and die fluid.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a lubricant 

and grease in penetrating lubricant.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as an adhesive 

and sealant in solvent-based adhesives and 

sealants; tire repair cement/sealer; mirror 

edge sealant.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a functional 

fluid in heat exchange fluid.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in paints and 

coatings as a diluent in solvent-based paints 

and coatings.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in cleaning and 

furniture care products in carpet cleaner and 

wipe cleaning.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in laundry and 

dishwashing products in spot remover.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in arts, crafts, 

and hobby materials in fixatives and finishing 

spray coatings.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in corrosion inhibitors and anti-scaling agents.Prohibit ............................................................. Prohibit. 

Industrial and commercial use as a processing 

aid for battery separator manufacturing and 

for the manufacturing of specialty polymeric 

microporous sheet materials; process solvent 

used in polymer fabric spinning, 

fluoroelastomer manufacture and Alcantara 

manufacture; extraction solvent used in 

caprolactam manufacture; precipitant used in 

beta-cyclodextrin manufacture.

Prohibit; includes a TSCA section 6(g) exemption for the industrial and commercial 

use as a processing aid for battery separator manufacturing + WCPP includes an 

ECEL of 0.0011 ppm for inhalation exposures to TCE as an eight-hour TWA based 

on developmental toxicity.

Prohibit; includes TSCA section 6(g) exemptions for the industrial and commercial use 

as a processing aid for battery separator 

manufacturing and for the manufacturing of 

specialty polymeric microporous sheet materials + WCPP includes an ECEL of 

0.0040 ppm for inhalation exposures to 

TCE as an eight-hour TWA based on 

immunotoxicity. 

Industrial and commercial use as ink, toner and 

colorant products in toner aid.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in automotive 

care products in brake parts cleaner.

Prohibit ............................................................. Prohibit. 


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TABLE 2—OVERVIEW OF PROPOSED REGULATORY ACTION AND ALTERNATIVE REGULATORY ACTION BY CONDITIONS OF

USE—Continued 

Condition of use 

Action 

Proposed regulatory action 1 Primary alternative action 

Industrial and commercial use in apparel and 

footwear care products in shoe polish.

Prohibit ............................................................. Prohibit. 

Industrial and commercial use in hoof polish; 

gun scrubber; pepper spray; other miscellaneous industrial and commercial uses.

Prohibit; includes a TSCA section 6(g) exemption for the industrial and commercial 

use as a laboratory chemical for essential 

laboratory activities and some research and 

development activities + WCPP includes an 

ECEL of 0.0011 ppm for inhalation exposures to TCE as an eight-hour TWA based 

on developmental toxicity.

Prohibit; includes a TSCA section 6(g) exemption for the industrial and commercial 

use as a laboratory chemical for essential 

laboratory activities + WCPP includes an 

ECEL of 0.0040 ppm for inhalation exposures to TCE as an eight-hour TWA based 

on immunotoxicity. 

Consumer use as a solvent in brake and parts 

cleaners.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in aerosol electronic degreaser/cleaner.Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in liquid electronic 

degreaser/cleaner.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in aerosol spray 

degreaser/cleaner.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in liquid degreaser/ 

cleaner.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in aerosol gun 

scrubber.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in liquid gun scrubber.Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in mold release ..... Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in aerosol tire 

cleaner.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a solvent in liquid tire cleaner Prohibit 2 ........................................................... Prohibit.2

Consumer use as a lubricant and grease in tap 

and die fluid.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a lubricant and grease in 

penetrating lubricant.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as an adhesive and sealant in 

solvent-based adhesives and sealants.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as an adhesive and sealant in 

mirror edge sealant.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as an adhesive and sealant in 

tire repair cement/sealer.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a cleaning and furniture care 

product in carpet cleaner.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a cleaning and furniture care 

product in aerosol spot remover.

Prohibit 2 ........................................................... Prohibit.2

Consumer use as a cleaning and furniture care 

product in liquid spot remover.

Prohibit 2 ........................................................... Prohibit.2

Consumer use in arts, crafts, and hobby materials in fixative and finishing spray coatings.Prohibit 2 ........................................................... Prohibit.2

Consumer use in apparel and footwear products in shoe polish.Prohibit 2 ........................................................... Prohibit.2

Consumer use in fabric spray ............................ Prohibit 2 ........................................................... Prohibit.2

Consumer use in film cleaner ............................ Prohibit 2 ........................................................... Prohibit.2

Consumer use in hoof polish ............................. Prohibit 2 ........................................................... Prohibit.2

Consumer use in toner aid ................................. Prohibit 2 ........................................................... Prohibit.2

Disposal to industrial pre-treatment, industrial 

treatment, or publicly owned treatment works.

Prohibit the disposal of TCE to industrial pretreatment, industrial treatment, or publicly 

owned treatment works; with a TSCA section 6(g) exemption for the disposal of TCE 

from cleanup projects.

Prohibit. 

1 Does not include exemptions under TSCA section 6(g); for certain industrial and commercial uses of TCE for DoD naval vessels and their 

systems, and in the maintenance, fabrication, and sustainment for and of such vessels and systems + WCPP, which includes an ECEL of 0.0011 

ppm for inhalation exposures to TCE as an eight-hour TWA based on developmental toxicity; or for 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 + WCPP, which includes an ECEL of 0.0011 ppm for inhalation exposures to TCE as an eight-hour TWA 

based on developmental toxicity. 2Prohibit manufacture, processing, and distribution in commerce for the consumer use. 


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VI. Rationale for the Proposed 

Regulatory Action and Primary 

Alternative Regulatory Action 

This unit describes how the 

considerations described in Unit III.B.3. 

were applied when selecting among the 

TSCA section 6(a) requirements to 

arrive at the proposed and primary 

alternative regulatory actions described 

in Unit V. 

A. Consideration of Risk Management 

Requirements Available Under TSCA 

Section 6(a) 

1. Proposed Regulatory Action 

a. Prohibition 

EPA considered a prohibition as a 

regulatory option and is proposing it for 

all manufacturing (including import), 

processing, distribution in commerce, 

use, and certain types of disposal of TCE 

(Unit V.A.). EPA proposes that 

prohibition is necessary to address the 

unreasonable risk for all occupational 

conditions of use after taking into 

consideration other combinations of 

controls such as a non-prescriptive 

WCPP or prescriptive controls (i.e., 

engineering controls, administrative 

controls, and PPE). As described in Unit 

V.A., EPA’s bases for the need for this 

regulatory approach are similar to those 

for the Agency’s determination of 

unreasonable risk, and include severity 

of the hazard, exposed populations, 

magnitude of risk, and uncertainties 

(Ref. 2). Throughout this proposed rule, 

EPA has described the severity of the 

hazard of TCE (including 

immunotoxicity, developmental, and 

cancer risks), based on the 2020 Risk 

Evaluation for TCE, as well as the 

populations exposed to the 52 

conditions of use that drive the 

unreasonable risk, which include 

numerous workers, ONUs, consumers, 

and bystanders, including PESS such as 

workers of reproductive age (in 

particular, older pregnant women). 

The significance of the magnitude of 

exposures for TCE is highlighted when 

considering the margins of exposure 

(MOEs, or the health point of departure 

for an endpoint divided by the exposure 

concentration) in the risk evaluation 

that estimate non-cancer risk for acute 

and chronic exposure. Estimated MOEs 

are compared to a benchmark, described 

in more detail in the risk evaluation, as 

part of the unreasonable risk 

determination (Refs. 1, 2). An MOE 

lower than the benchmark supports a 

determination of unreasonable risk of 

injury to health, based on noncancer 

effects. As an example, for commercial 

use of TCE in open top vapor 

degreasing, the chronic MOE for fetal 

cardiac defects is 0.0006, which is 

several orders of magnitude lower than 

then benchmark of 10. Even with 

engineering controls, the only way to 

reduce exposures more than 1,000-fold 

would be PPE with an APF of 10,000 

(Ref. 1). This level of APF would require 

workers to constantly wear a full-face 

self-contained breathing apparatus 

(SCBA) in pressure demand mode or 

other positive pressure mode, which is 

considered unsustainable for the longterm and the least preferred approach to 

worker protection in the hierarchy of 

controls. There are many documented 

limitations to successful 

implementation of respirators with an 

APF of 10,000, including difficulties in 

fit and use rendering them ineffective in 

actual application, preventing the 

assurance of consistent and reliable 

protection, regardless of the assigned 

capabilities of the respirator (Refs. 69, 

70) (63 FR 1152, January 8, 1998). EPA 

requests comments on subsections of 

conditions of use, which by nature of 

their infrequent occurrence, could meet 

the ECEL without having their 

employees wear high APF levels of PPE 

on a daily basis. Given that the 

magnitude of risk from TCE is so high, 

and that the extremely high level of PPE 

would be an ineffective long-term way 

of addressing that risk along with 

information provided by stakeholders, 

including during consultations (Refs. 

70, 31), EPA has significant uncertainty 

that any measures short of prohibition 

would be sufficient to address the 

unreasonable risk. Therefore, EPA 

proposes that prohibition is the 

preferred option to ultimately address 

unreasonable risk. EPA believes that the 

extremely low ppm level of the ECEL, 

while fully addressing unreasonable 

risk, will be infeasible for industry to 

reliably meet due to the need for a 

combination of engineering, 

administrative controls, and full-face, 

self-contained, air-supplied respirators. 

As such, the only way to protect human 

health consistently, reliably, and 

continually from unreasonable risk 

would be to prohibit TCE. 

Ultimately, a prohibition would result 

in elimination of unreasonable risk from 

TCE, rather than allowing TCE use to 

continue in perpetuity, which would 

necessitate burdensome requirements to 

achieve exposure reductions to 

implement a technically challenging 

long-term program to meet a very low 

exposure limit. Recognizing that longer 

compliance timeframes and TSCA 

section 6(g) time-limited exemptions 

would nevertheless be necessary for 

certain critical uses to continue for a 

period of time as, described previously 

in Units V.A.1.d., V.A.1.e., and V.A.1.f., 

it is necessary to protect workers, 

including PESS, such as older pregnant 

workers and ONUs (the group identified 

as most susceptible to fetal cardiac 

defects). Therefore, as described in Unit 

IV., EPA is proposing the WCPP ECEL 

of 0.0011 ppm, based on the fetal 

cardiac defects endpoint, so that the 

developing fetus is best protected. EPA’s 

primary alternative regulatory option 

bases the WCPP ECEL for TCE on the 

immunotoxicity endpoint. Because it 

would not be as protective for the subset 

of PESS that include older pregnant 

workers and ONUs as specific under 

TSCA section 6(b), the ECEL based on 

immunotoxicity was not put forth as the 

proposed ECEL. In other words, under 

the immunotoxicity ECEL of 0.0040 

ppm, workers and ONUs would be 

protected from immunosuppression 

resulting from an acute (eight-hour) 

exposure, and from an excess risk of 

cancer resulting from lifetime exposure, 

as well as other adverse health effects 

such as reproductive toxicity, liver 

toxicity, kidney toxicity, and 

neurotoxicity. When the ECEL of 0.0011 

ppm based on fetal cardiac defects is 

used, EPA expects that a fetus would be 

protected from the effects of maternal 

exposure by workers and ONUs, in 

addition to the protections noted 

previously. Given this gap in 

protectiveness, the immunotoxicity 

ECEL of 0.0040 ppm is being considered 

as the alternative regulatory option 

rather than the proposed approach. As 

noted in Unit V.A.2., EPA has 

significant uncertainty about the extent 

to which some members of the regulated 

community could measure or reliably 

meet either the ECEL of 0.0011 ppm (in 

the proposed WCPP) or the ECEL of 

0.0040 ppm (in the primary alternative 

regulatory action), which contributes to 

EPA’s proposal that prohibition is the 

best long-term risk management option 

for TCE. 

EPA understands that additional time 

may be necessary for certain processing 

and industrial and commercial 

conditions of use to achieve a full 

prohibition, including the need for 

upstream manufacturing, processing, 

and distribution in commerce for those 

uses to continue to ensure availability 

for the supply chain. In particular, EPA 

recognizes that processing TCE as a 

reactant/intermediate often takes place 

in unique closed-systems, and facilities 

processing TCE may need additional 

time to transition to adjust the physical 

plant design to accommodate an 

alternative manufacturing process or 

chemical substance and avoid 

significantly disrupting the supply 


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chain. For example, EPA understands 

that the manufacturing (including 

import) and processing of TCE as an 

intermediate for the manufacture of 

HFC–134a is expected to phase down 

(absent a TSCA prohibition) over time 

as users move to more climate-friendly 

alternatives under the requirements of 

the AIM Act. In this instance, EPA is 

proposing requirements as part of a 

WCPP to reduce the worker exposures 

to TCE until the prohibition compliance 

date. In addition, EPA recognizes that 

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 is a highly specific use 

with a uniquely long qualification 

process for alternatives. In the 

production of booster rocket nozzles, 

TCE is used in vapor degreasing as a 

solvent in rayon fabric sourcing, an 

intensive cleaning process to remove 

contaminants. This rayon fabric is then 

carbonized as part of an ablative process 

in the nozzle production and used to 

line the inside of the nozzles on booster 

rockets (Ref. 43). Cleaning is a critical 

step of this process; if contaminants are 

not sufficiently removed in the scouring 

stage, the fabric will be degraded during 

the chemical reaction that occurs during 

carbonization, which could result in 

failure of the nozzle during a launch 

and catastrophic effects for the rockets. 

For this use, NASA has presented 

information to EPA on the necessity of 

additional time to transition to an 

alternative, given that 8 rocket launches 

are planned using booster sets with a 

component produced with TCE (Ref. 

43). These launches could not occur if 

prohibition occurred on a shorter 

timeframe. In particular, given the end 

use of the components in human-rated 

spaceflight, EPA recognizes that NASA 

must conduct an array of tests to qualify 

an alternative solvent to TCE, including 

a variety of booster rocket function tests 

culminating in a full-scale static motor 

test. Even if an alternative were 

identified and qualified through a 

successful testing cycle, additional time 

would be needed for updates to 

workflows and production of new 

booster nozzles (Ref. 43). As such, EPA 

has provided additional time for the 

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. EPA recognizes that 

other Federal agencies may also rely on 

rayon fabric scouring for their rocket 

booster nozzle production and so 

proposes that the phaseout for this subset of the industrial and commercial use 

of TCE as a solvent in closed-loop batch 

vapor degreasing apply to Federal 

agencies generally and their contractors. 

As a condition for the phaseout, EPA 

has specified that a final pre-launch test 

of rocket booster nozzles without using 

TCE must be conducted within 5 years, 

with a full prohibition in 10 years on 

the use of TCE in scouring rayon fabric 

for end use in nozzles in rocket 

boosters. For this phaseout period, EPA 

is proposing requirements as part of a 

WCPP to reduce the worker exposures 

to TCE until the prohibition compliance 

date, and Unit V.A.2. explains that the 

establishment of a WCPP is intended to 

allow more flexibility to regulated 

entities than requiring specific 

prescriptive controls. Similarly, EPA is 

proposing the WCPP to reduce to the 

extent possible the unreasonable risk 

until the prohibition compliance date 

for certain conditions of use that would 

be permitted to continue for longer than 

a year after publication of the final rule, 

as discussed in Unit V.A. 

Additionally, prohibition is the 

preferred option for occupational 

conditions of use where reasonably 

available information suggests minimal 

ongoing use or when feasible safer 

alternatives are reasonably available. As 

described in this unit, EPA is highly 

uncertain as to whether users could 

comply with the requirements of a TCE 

WCPP, and EPA is also concerned with 

the severity of the risks of TCE. EPA 

notes the prevalence of alternative 

processes and products (Unit VI.B.). In 

some cases, reasonably available 

information indicating a use is no longer 

ongoing (Refs. 71, 3), has led EPA to 

propose more immediate prohibitions 

for most industrial and commercial uses 

of TCE, including the upstream 

manufacturing, processing, and 

distribution in commerce for those uses. 

EPA requests public comment on the 

rationale for proposing prohibitions as 

the preferred risk management 

approach. In addition, EPA requests 

comment regarding the number of 

businesses and other entities that could 

potentially close as well as associated 

costs with a prohibition of TCE for the 

industrial and commercial conditions of 

use identified in Unit V.A.1. 

TSCA section 6(a)(2) provides EPA 

with the authority to prohibit or 

otherwise restrict the manufacture 

(including import), processing, or 

distribution in commerce of a substance 

or mixture ‘‘for a particular use’’ to 

ensure that a chemical substance no 

longer presents unreasonable risk. For 

this rulemaking, EPA proposes that ‘‘for 

a particular use’’ include consumer use, 

which encompasses all known, 

intended, and reasonably foreseen 

consumer uses for TCE (Ref. 1). Given 

the severity and ubiquitous nature of the 

risks identified in the 2020 Risk 

Evaluation for TCE for processing of 

TCE into formulation as well as for all 

but one consumer use (pepper spray) 

and, noting that those conditions of use 

encompass all known, intended, and 

reasonably foreseen consumer use, EPA 

proposes that prohibiting manufacture 

(including importing), processing, and 

distribution in commerce of TCE for 

consumer use is reasonable and 

necessary to address the unreasonable 

risk from TCE driven by manufacturing 

(including importing) and processing 

TCE into formulation (the upstream 

conditions of use for products intended 

for consumer use), and that this 

proposed approach will also address the 

unreasonable risk to consumers and 

bystanders. Furthermore, amongst the 

broad prohibition of TCE, EPA 

considered and acknowledges the likely 

future unavailability of TCE for the 

consumer use of pepper spray, and EPA 

expects the prohibition on industrial 

and commercial use of TCE in pepper 

spray, as well as the upstream 

prohibition on manufacturing, 

processing, and distribution of TCE for 

commercial or consumer uses, would 

result in no TCE-containing pepper 

spray being produced for consumer use 

(Ref. 71). 

Details of the proposed prohibitions 

are described in more detail in Unit 

V.A. 

b. Workplace Chemical Protection 

Program (WCPP) 

i. Overall. Prohibition is the preferred 

option for all occupational COUs, 

because significant uncertainty exists 

relative to any sector’s ability to comply 

with a notably low exposure limit for 

TCE, particularly given the magnitude 

of exposure for many conditions of use 

(see Unit V.A.1.). A more immediate 

prohibition is the preferred option for 

occupational conditions of use where 

greater uncertainty exists relative to a 

sector’s ability to comply with 

provisions of a WCPP, in particular a 

very low ECEL, as well as additional 

requirements that would support 

implementation of these restrictions 

(described in Unit V.A.2.). The 8-hour 

TWA ECEL of 0.0011 ppm for TCE that 

EPA is proposing, based on the 

developmental toxicity endpoint, is 

significantly lower than the OSHA PEL 

of 100 ppm, and there is a high degree 

of uncertainty as to whether users under 

the conditions of use in any sector 

would be able to comply with such a 

level and, thus, whether the 


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unreasonable risk would be addressed. 

However, to address, to the extent 

possible, the unreasonable risk during 

the time period before a prohibition 

would become effective, EPA is 

proposing a WCPP until the prohibition 

compliance date. The WCPP would 

include a combination of restrictions to 

reduce the unreasonable risk from TCE 

driven by inhalation and dermal 

exposures in the workplace until the 

prohibition compliance date and is 

proposed only for certain conditions of 

use. EPA requests public comment 

related to the ability of regulated entities 

to meet the ECEL of 0.0011 ppm, and 

whether EPA should prescribe 

mandatory restrictions and PPE levels. 

ii. Existing Chemical Exposure Limit. 

One requirement considered by EPA to 

include in a TCE WCPP to reduce the 

unreasonable risk driven by inhalation 

exposures to TCE for occupational 

conditions of use was establishing an 

ECEL and related implementation 

measures, such as exposure monitoring, 

until the prohibition compliance date. 

As described in Unit V.A., the TCE 

WCPP would be non-prescriptive, in the 

sense that regulated entities would not 

be required to use specific controls 

prescribed by EPA to achieve the 

exposure concentration limit. Rather, it 

would be a performance-based exposure 

limit that would enable owners or 

operators to determine how to most 

effectively put measures in place to 

reduce the exposure to TCE based on 

conditions at their workplace, 

consistent with the hierarchy of 

controls. 

A central component of the TCE 

WCPP is the exposure limit. Exposures 

remaining at or below the ECEL would 

address any unreasonable risk of injury 

to health driven by inhalation exposures 

for occupational conditions of use. In 

the case of TCE, EPA has calculated the 

ECEL to be 0.0011 parts per million 

(ppm) (0.0059 mg/m3) for inhalation 

exposures as an 8-hour TWA in 

workplace settings, based on the most 

sensitive acute non-cancer occupational 

HEC for fetal cardiac defects (Ref. 13). 

The differences between the ECEL and 

the OSHA PEL are discussed in more 

detail in Unit II.C.1.b. EPA chose the 

acute non-cancer developmental 

toxicity endpoint for TCE as the basis 

for the exposure limit for the proposed 

regulatory action as it is the most 

sensitive endpoint and, therefore, would 

be protective of both acute and chronic 

non-cancer as well as cancer inhalation 

endpoints over the course of a working 

day and lifetime, including for 

potentially exposed or susceptible 

subpopulations (additional explanation 

is in Unit VI.A.). However, as discussed 

in Unit V.A.2., EPA expects that 

detection of and adherence to extremely 

low-ppm levels of TCE may present 

challenges to the regulated community 

(Ref. 45), and so EPA is proposing the 

WCPP until the prohibition compliance 

date. EPA emphasizes the time limited 

nature of this WCPP, due to the likely 

need for reliance on air-supplied 

respirators of APF 1,000 or 10,000 that 

would be needed to address the 

unreasonable risk, even when 

engineering and administrative controls 

are put into place. More details are 

provided later in this unit. 

iii. Dermal protection. As part of the 

WCPP, EPA is proposing to require use 

and provision of chemically resistant 

gloves by potentially exposed persons in 

combination with specific activity 

training (e.g., appropriate procedures for 

glove removal, replacement, and 

disposal) for tasks where dermal 

exposure can be expected to occur. 

However, EPA understands these tasks 

are expected to occur for conditions of 

use, such as processing TCE as a 

reactant, where closed system processes 

are already in place to minimize 

exposure to TCE. EPA is not proposing 

to require owners or operators to 

document consideration of the 

hierarchy of controls for dermal 

exposures to TCE because EPA intends 

to prohibit all uses of TCE, EPA is 

proposing relatively rapid compliance 

dates for the prohibitions for most uses 

of TCE, and dermal PPE programs are 

somewhat more straightforward to 

implement than respiratory PPE 

programs. In proposing dermal 

requirements, EPA took into 

consideration the volatile nature of TCE 

because the dermal absorption of TCE 

depends on the type and duration of 

exposure. For the conditions of use that 

would be subject to the WCPP, EPA also 

considered the unique, closed system 

processes of each use which aid to 

reduce dermal exposure. 

iv. WCPP considerations. EPA is 

proposing a WCPP for several 

conditions of use of TCE to reduce the 

unreasonable risk to the extent possible 

during the time period before a 

prohibition becomes effective, described 

in Unit V.A.2. 

In deciding whether an ECEL and 

related required measures would 

appropriately reduce the unreasonable 

risk driven by occupational inhalation 

exposures, EPA considered factors 

related to work activities that may make 

it difficult to comply with an ECEL, 

particularly at the low air concentration 

level EPA has identified. Once EPA 

identified the appropriate risk-based 

inhalation limit to reduce identified 

unreasonable risk, EPA carefully 

considered the appropriateness of such 

an exposure control program for each 

occupational condition of use of TCE, in 

the context of the unreasonable risk. 

Examples include conditions of use 

with work activities that may take place 

in the field, making it challenging to 

establish a regulated area and conduct 

monitoring; work activities that may 

take place in open systems that require 

manual contact with the chemical 

substance; work activities that may take 

place in small, enclosed spaces, creating 

challenges for implementing 

engineering controls or using respiratory 

PPE; work activities that require a high 

range of motion or for some other reason 

create challenges for the 

implementation of respiratory PPE; and 

the type of PPE that would be needed 

under the TCE WCPP to meet the ECEL 

in the absence of, or in addition to, 

other feasible exposure controls, based 

on analysis in the 2020 Risk Evaluation 

for TCE describing expected exposures 

with and without use of PPE. 

EPA also considered the feasibility of 

exposure reduction sufficient to reduce 

the unreasonable risk, including in 

facilities currently complying with the 

OSHA PEL for TCE or implementing 

other recommended OELs such as the 

ACGIH TLV. While EPA acknowledges 

the regulated community’s expected 

familiarity with OSHA PELs generally, 

as well as facilities’ past and ongoing 

actions to implement the TCE PEL, the 

value of EPA’s exposure limit is almost 

five orders of magnitude lower than the 

OSHA PEL. (The differences between 

the ECEL and the OSHA PEL are 

discussed in more detail in Unit II.C.4.) 

This creates a significant degree of 

uncertainty as to whether facilities 

engaging in most conditions of use 

could implement engineering or 

administrative controls to reduce 

exposures in a manner aligned with the 

hierarchy of controls to meet the ECEL 

(and associated action level) and 

whether they could do so without 

relying primarily on the use of PPE 

(which is the least preferred option in 

the hierarchy of controls) to supplement 

exposure reduction efforts. 

EPA understands that this uncertainty 

extends to the feasibility of respirators 

as a long-term risk management practice 

as well, since the complexity and 

burden of wearing respirators increases 

with increasing APF. Although 

respirators, specifically SCBAs (APF 

10,000), could reduce exposures to 

levels that protect against non-cancer 

and cancer risks, not all workers may be 

able to wear respirators. Individuals 

with impaired lung function due to 

asthma, emphysema, or chronic 

obstructive pulmonary disease, for 


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example, may be physically unable to 

wear a respirator. OSHA requires that a 

determination regarding the ability to 

use a respirator be made by a physician 

or other licensed health-care 

professional, and annual fit testing is 

required for tight-fitting, full-face piece 

respirators to provide the required 

protection. Individuals with facial hair, 

such as beards or sideburns that 

interfere with a proper face-to-respirator 

seal, cannot wear tight fitting 

respirators. In addition, respirators may 

also present communication problems, 

vision problems, worker fatigue, and 

reduced work efficiency (63 FR 1152, 

January 8, 1998). According to OSHA, 

‘‘improperly selected respirators may 

afford no protection at all (for example, 

use of a dust mask against airborne 

vapors), may be so uncomfortable as to 

be intolerable to the wearer, or may 

hinder vision, communication, hearing, 

or movement and thus pose a risk to the 

wearer’s safety or health.’’ (63 FR 1189 

through 1190). Furthermore, depending 

on the air concentrations and proximity 

to the regulated area, other employees in 

the area may also need to wear 

respiratory PPE. EPA understands, 

based on reasonably available 

information, that occupational 

exposures tend to fluctuate depending 

on the task being performed and the 

frequency of the task, which could 

create challenges for reliably effective 

implementation of respiratory PPE 

(Refs. 70, 72, 35). 

EPA reviewed reasonably available 

information, including monitoring data, 

and information related to 

considerations described previously in 

this unit. EPA expects attempts to 

implement the WCPP to include 

increased monitoring and that industry 

would likely need to exclusively rely on 

PPE when aiming to reach the ECEL, 

including the use of high APF 

respirators, such as fit-tested, airsupplied respirators of APF 1,000 or 

APF 10,000. Given the high APF of 

respirators that are likely needed to 

reach the ECEL, EPA recognizes that 

this equipment and its programmatic 

maintenance could be highly 

burdensome. EPA believes this could 

create implementation challenges and is 

not a long-term, sustainable use of the 

WCPP. The WCPP would be in place for 

a relatively short period of time (less 

than 10 years for the vast majority of 

production value) until the eventual 

prohibition, because of the likely need 

for such extensive PPE. The ultimate 

goal for TCE is prohibition given the 

difficulty of maintaining a WCPP long 

term. 

One of the conditions of use for which 

EPA is proposing a WCPP until the 

prohibition goes into effect is processing 

TCE as a reactant/intermediate. The 

majority of the annual production 

volume of TCE processed as an 

intermediate under this condition of use 

goes almost entirely toward the 

manufacture of one HFC, HFC–134a 

(Refs. 3, 70, 73). Monitoring information 

submitted by facilities processing TCE 

as an intermediate to manufacture HFC– 

134a suggests that TCE is largely 

confined to the process reactors, which 

require infrequent loading and 

unloading activities taking place 

approximately 20 times per year and 

resulting in low-ppm TCE exposure 

levels (Ref. 70). The information 

submitted also highlights that TCE is 

consumed and transformed during the 

reaction process (Ref. 70). Additionally, 

HFC–134a is one of the regulated 

substances that are subject to a 

phasedown under the AIM Act, and as 

discussed in Unit I.D., EPA understands 

that HFC–134a has a lower GWP 

compared to other refrigerants, which 

will likely continue to be used to 

facilitate the transition from certain 

other HFCs pursuant to the phasedown 

under the AIM Act. Providing a longer 

phaseout under TSCA for processing 

TCE as an intermediate for the 

manufacture of HFC–134a, while subject 

to a WCPP, is consistent with the 

agency’s efforts to address climatedamaging HFCs, such as HFC–134a, 

under the AIM Act. EPA is seeking 

comment on the actions that 

manufacturers who process TCE for the 

production of HFC–134a would take as 

a result of this proposed phaseout and 

whether this would motivate a decision 

to cease manufacture earlier than they 

would otherwise under the AIM Act 

phase-down. For the remaining volume 

of TCE processed as a reactant/ 

intermediate for chemical synthesis 

other than manufacturing HFC–134a, 

additional time may be necessary to 

reconfigure or otherwise adjust the 

physical plant to accommodate an 

alternative manufacturing process, so a 

WCPP is also associated with the 

prohibition of other processing as a 

reactant/intermediate uses; however, the 

phaseout does not apply to the other 

uses for which EPA is proposing a more 

immediate prohibition discussed in 

Unit V.A. 

Additionally, EPA considered other 

industrial and commercial uses as 

candidates for a WCPP. Similar to the 

processing of TCE as a reactant/ 

intermediate, unique, closed-system 

processes exist for the industrial and 

commercial use as: processing aid in 

process solvent used in battery 

manufacture; a process solvent used in 

polymer fiber spinning, fluoroelastomer 

manufacture and Alcantara 

manufacture; an extraction solvent used 

in caprolactam manufacture; and a 

precipitant used in beta-cyclodextrin 

manufacture. Where TCE is used as a 

processing aid, TCE is consumed or 

captured and reused in the process. 

Monitoring data suggests low-ppm TCE 

exposure levels but may involve daily 

worker tasks. EPA understands that 

some of the industrial and commercial 

uses of TCE as a processing aid occur 

outside of the U.S., or may no longer be 

ongoing in the U.S. However, EPA 

received and reviewed substantive 

information from the battery separator 

manufacturing industry, specifically for 

lead-acid and lithium-ion battery 

separator manufacturing processes, 

along with a request for a TSCA section 

6(g) exemption under this TSCA 

rulemaking. EPA agrees that battery 

separator manufacturing is critical to the 

national economy and national security; 

therefore, EPA is proposing to grant a 

10-year exemption from the prohibition 

for the industrial and commercial use of 

TCE as a processing aid for battery 

separator manufacturing. For this 

exemption EPA is proposing to impose 

the WCPP requirements as a condition 

for the TSCA section 6(g) exemption. 

All other industrial and commercial 

processing aid uses (e.g., process solvent 

used in polymer fabric spinning, 

fluoroelastomer manufacture, etc.) must 

comply with the more stringent 

prohibition detailed in Unit V.A. 

Furthermore, EPA considered 

industrial and commercial uses of TCE 

as an essential laboratory chemical as 

necessary to continue following the 

WCPP requirements, during the period 

of the TSCA section 6(g) time-limited 

exemption described in Unit V.A. 

Industrial and commercial use as a 

laboratory chemical is necessary to 

provide for the analysis of monitoring 

samples required to implement the 

ECEL requirements under the WCPP as 

part of this proposed regulation, as well 

as for essential chemical analysis, 

including for ongoing cleanup projects 

that fall under the Superfund program 

or other EPA jurisdictions, described in 

Unit V.A.3. Furthermore, EPA expects 

laboratory settings to be more conducive 

to the implementation of engineering 

controls such as fume hoods to ventilate 

vapors and reduce overall exposure to 

TCE in alignment with the hierarchy of 

controls. 

Lastly, for TCE to be available for the 

downstream uses described in this unit, 

it must be manufactured (including 

imported), processed, and distributed in 

commerce. Therefore, as discussed in 

Unit V.A., EPA is proposing the WCPP 


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for manufacturing (including importing) 

and processing for certain industrial and 

commercial uses, to allow a continuous 

supply chain for the specified 

conditions of use expected to continue 

1 year after the final rule is published 

until the prohibition compliance dates. 

2. Primary Alternative Regulatory 

Action 

EPA acknowledges that, for some 

conditions of use that it is proposing to 

prohibit, there may be some activities or 

facilities that need longer compliance 

timeframes in order to appropriately 

transition. Therefore, the primary 

alternative regulatory action accounts 

for additional time under a prohibition 

to provide the flexibility for facilities to 

comply, for example, to account for 

issues in the supply chain, such as the 

availability of alternatives to 

reformulate products. In selecting 

among the TSCA section 6(a) 

requirements for the primary alternative 

regulatory action for use of TCEcontaining products, EPA considered 

risk-related factors, including but not 

limited to, the population exposed and 

the severity of the hazard of TCE and, 

separately, of other alternative solvents, 

which are undergoing risk evaluation 

and risk management under TSCA 

section 6, such as PCE (as part of a 

separate rulemaking under RIN 2070– 

AK84). For example, there may be 

instances where PCE and TCE may be 

desired because they are non-flammable 

solvents used as cleaning agents for 

energized electrical equipment (e.g., 

circuit boards). In these instances, 

additional time may be needed to 

identify an alternative chemical or 

process to avoid flammability concerns. 

EPA also considered a TSCA section 

6(g) time-limited exemption for 

additional conditions of use that are 

critical or essential, or where a 

prohibition could have significant 

impacts on the national economy, 

national security, and infrastructure As 

described in Unit V.B.3.a.ii., EPA 

requests comments on a TSCA section 

6(g) exemption, and based on the 

information received may find that an 

exemption may be warranted under the 

primary alternative regulatory action for 

the industrial and commercial use of 

TCE in batch vapor degreasing for 

critical aerospace or medical device 

applications, if the workplaces engaged 

in that condition of use cannot meet the 

requirements of the proposed regulatory 

action. 

Similar to the proposed regulatory 

action, the primary alternative 

regulatory action would include a 

WCPP for several conditions of use of 

TCE to reduce to the extent possible the 

unreasonable risk during the time 

period before a prohibition becomes 

effective, including as a condition to the 

TSCA section 6(g) exemption, per TSCA 

section 6(g)(4). For the implementation 

of the TCE WCPP, EPA considered 

providing additional time under the 

primary alternative regulatory action for 

the WCPP requirements given the 

difference in order of magnitude for the 

exposure limit under TSCA compared to 

levels required by OSHA or other 

recommended guidelines. These 

provisions would include, for instance, 

identifying appropriate monitoring 

methods to comply with an TSCA 

exposure limit that is five orders of 

magnitude lower than the OSHA PEL 

(i.e., 0.0040 ppm vs. 100 ppm, 

respectively), as well as providing for 

respiratory protection corresponding to 

a higher assigned protection factor than 

required by OSHA, further described in 

Unit II.C. 

Further, the WCPP under the primary 

alternative regulatory action would 

include an ECEL of 0.0040 ppm to 

address inhalation exposures to TCE in 

occupational settings that is based on 

the immunotoxicity endpoint. EPA 

believes that this ECEL would be less 

protective than the ECEL of 0.0011 ppm 

based on the developmental toxicity 

endpoint, that EPA would require under 

the proposed regulatory action. (A 

summary of EPA’s risk evaluation 

activities under TSCA is provided in 

Unit II.D., and the health effects of TCE, 

including the difference in the two 

human health endpoints as the basis for 

the two different ECELs, are discussed 

in Unit VI.A.) EPA considered the 

extremely low-ppm values of both 

ECELs and acknowledges the 

uncertainties regarding the ability of 

traditional industrial hygiene methods 

to meet the limit of detection associated 

with either ECEL action level, and the 

feasibility of combining existing 

engineering and administrative controls 

to reduce the exposure of TCE to 

extremely low-ppm levels before relying 

on PPE. Therefore, EPA does not 

consider long-term implementation of 

the WCPP a feasible means of 

addressing unreasonable risk 

indefinitely; as such, prohibition of the 

affected conditions of use is ultimately 

necessary to address the unreasonable 

risk under both the proposed and 

primary alternative regulatory actions. 

The primary alternative regulatory 

action is described in more detail in 

Unit V.B. 

3. Risk Management Requirements 

Considered But Not Proposed 

EPA considered but is not proposing 

to regulate the weight fraction of TCE in 

products for industrial and commercial 

or consumer use because TCE is the 

main constituent (e.g., cleaning 

component) of the majority of TCEcontaining product formulations and 

EPA understands that decreasing the 

concentration of TCE decreases the 

efficacy of the product (Refs. 74, 75). 

EPA also examined the extent to 

which a self-certification and limitedaccess program restricting TCE use to 

trained and licensed users could ensure 

that only certain workers employed by 

a facility would be able to purchase and 

subsequently use TCE. Under a limited 

access program such as a point-of-sale 

self-certification, entities would submit 

a self-certification to the distributor at 

the point of purchasing the products. 

The self-certification could consist of a 

statement indicating that the facility is 

implementing the required workplace 

safety measures to control exposures to 

TCE. However, a point-of-sale selfcertification is not a viable option for 

this proposed rulemaking. Given the 

eventual full prohibition of TCE and the 

significant investments users may have 

to make toward establishing a WCPP, 

EPA does not believe it would be 

practicable to add an additional burden 

of implementing a limited access 

program. Therefore, EPA is not 

proposing a self-certification and 

limited access program as part of this 

rulemaking. EPA requests comment on 

the effectiveness of a limited access 

program, such as a point-of-sale selfcertification or other administrative 

controls, to address the unreasonable 

risk of TCE, in particular for facilities 

with occupational exposures to TCE that 

may not be able to meet the WCPP 

requirements of this proposed 

rulemaking. 

Another option that EPA considered 

was requiring prescribed engineering 

controls, administrative controls, or 

personal protective equipment to reduce 

exposures to TCE in occupational 

settings. Prescriptive requirements 

would be supported by information in 

the 2020 Risk Evaluation for TCE. 

However, as described in Unit III.A.1. 

and 2., EPA received input during 

required consultations and additional 

stakeholder engagement that regulatory 

options that align with the hierarchy of 

controls (i.e., elimination and 

substitution of hazards in the 

workplace) should be preferred over 

prescriptive controls (which 

alternatively could be accomplished 

through the implementation of a WCPP 

with a risk-based exposure limit) (Refs. 

12, 31). Inadequacy of engineering, 

administrative, and personal protective 

equipment control measures to lower 

exposure below the exposure limit 


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would mean that elimination or 

substitution would be the only viable 

methods of addressing unreasonable 

risk. Additionally, the WCPP approach 

EPA is considering under the proposed 

action is a more flexible approach as 

prescriptive controls present significant 

uncertainties related to their feasibility, 

given the site-specific operations and 

variable configurations, and need for 

consistency of proper use. 

EPA determined that such controls 

(i.e., engineering or administrative 

controls, or PPE) may not be able to 

eliminate unreasonable risk for some 

conditions of use when used in 

isolation. In the 2020 Risk Evaluation 

for TCE, many conditions of use still 

drive unreasonable risk even with the 

application of air-supplied APF 50 

respirators (Ref. 1). Reasonably available 

data indicated additional uncertainty 

regarding the feasibility of exposure 

reductions through engineering controls 

alone, considering the unique closedsystem processes already in place (Refs. 

70, 48). For occupational conditions of 

use, prohibitions (rather than prescribed 

controls) would be more appropriate to 

ensure the elimination of unreasonable 

risk of TCE. Nevertheless, EPA 

determined that a WCPP, including 

requirements for an ECEL (which would 

be accompanied by monitoring 

requirements) in tandem with the 

implementation of engineering controls, 

administrative controls, and/or PPE, as 

appropriate, would be necessary for 

reducing exposures to TCE prior to the 

proposed prohibition compliance dates. 

4. Additional Considerations 

After considering the different 

regulatory options under TSCA section 

6(a), alternatives (described in Unit 

V.B.), compliance dates, and other 

requirements under TSCA section 6(c), 

EPA developed the proposed regulatory 

action described in Unit V.A. to address 

the unreasonable risk from TCE so that 

it is no longer unreasonable. To ensure 

successful implementation of this 

proposed regulatory action, EPA 

considered other requirements to 

support compliance with the proposed 

regulations, such as requiring 

monitoring and recordkeeping to 

demonstrate compliance with a WCPP 

and downstream notification regarding 

the prohibition on manufacturing 

(including import), processing, and 

distribution in commerce of TCE, and 

products containing TCE, for industrial 

and commercial use as well as 

consumer uses. These proposed 

requirements are described in Unit V.A. 

As required under TSCA section 6(d), 

any rule under TSCA section 6(a) must 

specify mandatory compliance dates, 

which shall be as soon as practicable 

with a reasonable transition period, but 

no later than 5 years after the date of 

promulgation of the rule (except in the 

case of a use exempted under TSCA 

section 6(g) or for full implementation 

of ban or phaseout requirements). These 

compliance dates are detailed in Units 

V.A. and V.B. EPA may finalize 

significantly shorter or longer 

compliance timeframes based on 

consideration of public comments. 

B. Consideration of Alternatives in 

Deciding Whether To Prohibit or 

Substantially Restrict TCE 

Under TSCA section 6(c)(2)(C), in 

deciding whether to prohibit or restrict 

in a manner that substantially prevents 

a specific condition of use of a chemical 

substance or mixture, and in setting an 

appropriate transition period for such 

action, EPA must consider, to the extent 

practicable, whether technically and 

economically feasible alternatives that 

benefit human health or the 

environment, compared to the use so 

proposed to be prohibited or restricted, 

will be reasonably available as a 

substitute when the proposed 

prohibition or other restriction takes 

effect. To that end, in addition to an 

Economic Analysis (Ref. 3), EPA 

conducted an Alternatives Assessment, 

using reasonably available information 

(Ref. 71). 

For this assessment, EPA identified 

and analyzed alternatives to TCE in 

products relevant to industrial, 

commercial, and consumer conditions 

of use proposed to be prohibited or 

restricted. Based on reasonably available 

information, including information 

submitted by industry, EPA understands 

viable alternatives to TCE may not be 

available for several conditions of use, 

for example, processing TCE as an 

intermediate for the manufacture of 

HFC–134a, and considered that 

information to the extent practicable in 

the development of the regulatory 

options as described in Unit III.B.3. For 

some conditions of use, EPA was unable 

to identify products currently available 

for sale that contain TCE. EPA is 

soliciting comments on whether there 

are products in use or available for sale 

relevant to these conditions of use that 

contain TCE at this time, so that EPA 

can ascertain whether there are 

alternatives that benefit human health 

or the environment as compared to such 

use of TCE. These conditions of use are 

detailed in the Alternatives Assessment 

(Ref. 71). 

For conditions of use for which 

products currently containing TCE were 

identified, EPA identified several 

hundred commercially available 

alternative products that do not contain 

TCE, and listed in the Alternatives 

Assessment, to the extent practicable, 

their unique chemical components, or 

ingredients. For each of these chemical 

components or ingredients, EPA 

identified whether it functionally 

replaced TCE for the product use and 

screened product ingredients for human 

health and environmental hazard, as 

well as identified flammability and 

global warming potential where 

information was reasonably available 

(Ref. 71). EPA then assigned a rating to 

the human health and environmental 

hazards, using a methodology described 

in the Alternatives Assessment 

document. In general, EPA identified 

products containing ingredients with a 

lower hazard screening rating than TCE 

for certain endpoints, while some 

ingredients presented higher hazard 

screening ratings than TCE (Ref. 71). 

These alternative hazard screening 

ratings are described in detail in the 

Alternatives Assessment grouped under 

common product use categories (Ref. 

71). 

Discussion of alternatives to TCE was 

discussed during the SBAR Panel 

process outreach meetings. EPA’s 

consideration of alternatives was 

informed by the information provided 

by SERs, which included known 

problems and risks with several 

available alternatives, such as 

flammability, toxicity, and water 

limitations due to drought. Specifically, 

SERs discussed how some chlorinated 

solvents are currently undergoing TSCA 

risk evaluations, while other 

alternatives may be labeled as severe 

fire hazards by the National Fire 

Protection Association. SERs also 

mentioned that in the automotive and 

aerospace industries, alternative solvent 

degreasers may have their own hazard 

profile, which can include flammability, 

lower boiling temperatures, and toxicity 

(Ref. 32). SERs expressed concern for 

future regulation of chemicals 

undergoing risk evaluation, and also 

described the challenges of alternative 

processes, such as aqueous methods. 

Specifically, SERs described how in 

certain regions it is difficult to justify 

installation of these systems due to 

limited space or water availability. One 

SER provided an account about one of 

their customers, who had an aqueous 

cleaning system installed and was 

unable to source the required amount of 

water to run it. EPA notes the concerns 

expressed by SERs regarding availability 

of feasible alternatives that could be 

subject to market forces that may impact 

availability of alternatives (e.g., certain 

fluorinated chemicals) or potentially be 


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subject to future EPA regulations. EPA 

notes that SERs described how available 

alternatives for lubricants in spray 

applications are mostly fluorinated 

organic compounds; although nonfluorinated options may exist, the SERs 

expressed concern for future potential 

regulatory activity. A trade organization 

SER highlighted that some fluorinated 

alternatives to TCE are under increased 

regulatory scrutiny, especially at state 

levels, because they may be subject to 

state PFAS laws based on their chemical 

structure and properties (Ref. 32). These 

discussions with SERs informed the 

Panel recommendations. 

EPA has considered input from SERs 

and other stakeholders regarding 

alternatives to TCE, as well as the 

information used for the Alternatives 

Assessment. In deciding whether to 

propose prohibition or other significant 

restrictions on a condition of use of TCE 

and in proposing an appropriate 

transition period for any such action, 

EPA has therefore, pursuant to TSCA 

section 6(c)(2)(C), considered, to the 

extent practicable, whether technically 

and economically feasible alternatives 

that benefit human health or the 

environment, compared to the use 

proposed to be prohibited or restricted, 

would be reasonably available as a 

substitute when a proposed prohibition 

or other significant restriction would 

become effective. EPA is additionally 

requesting comment on the Alternatives 

Assessment as a whole. 

VII. TSCA Section 6(c)(2) 

Considerations: Magnitude of Human 

Exposure, Environmental Effects of 

TCE, Benefits of TCE for Various Uses, 

and Reasonably Ascertainable 

Economic Consequences 

As described in Unit IV., 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. 

EPA’s consideration of the health effects 

of TCE is in Unit IV.; EPA’s 

consideration of the remaining 

considerations under TSCA section 

6(c)(2) are in this unit. 

A. Magnitude of Human Exposure to 

TCE 

TSCA section 6(c)(2)(B) directs EPA to 

factor in, to the extent practicable, the 

magnitude of human exposure to TCE 

under TSCA section 6(c)(2)(A). EPA’s 

analysis of the magnitude of human 

exposure to TCE are in the 2020 Risk 

Evaluation for TCE (Ref. 1). A summary 

is presented here. 

Regarding the magnitude of human 

exposure, one factor EPA considers for 

the conditions of use that drive 

unreasonable risk is the size of the 

exposed population which, for TCE, 

EPA estimates is 43,675 workers, 8,920 

ONUs, and 20,600 consumers (Ref. 3). 

For the conditions of use that drive 

the unreasonable risk for TCE, PESS 

include workers and occupational nonusers (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. 

In addition to workers, ONUs, 

consumers, and bystanders to consumer 

use directly exposed to TCE, EPA 

recognizes there is exposure to the 

general population from air and water 

pathways for TCE. As mentioned in 

Unit II.D., EPA has separately 

conducted a screening approach to 

assess whether there may be potential 

risks to the general population from 

these exposure pathways. The screening 

approach was developed in order to 

allow EPA to determine—with 

confidence—situations which present 

no unreasonable risk to fenceline 

communities or where further 

investigation would be needed to 

develop a more-refined estimate of risk. 

The fenceline technical support memos 

for the ambient air pathway and the 

water pathway provide the Agency with 

a quantitative assessment of exposure. 

For TCE, the results from applying this 

screening approach did not allow EPA 

to rule out unreasonable risk to 

fenceline communities. This unit 

summarizes the results of that fenceline 

analysis. Although EPA is not making a 

determination of unreasonable risk 

based on the fenceline screening 

analysis, the proposed regulatory action 

described in Unit V.—which would 

ultimately prohibit all conditions of use 

of TCE is expected to eliminate the risks 

identified in the screening approach. 

As described in Unit II.D., EPA’s 

analysis methodology was presented to 

the SACC peer review panel in March 

2022, and EPA considered SACC 

feedback (including the SACC 

recommendation to EPA to consider 

multiple years of release data to 

estimate exposures and associated risks) 

when applying the fenceline analysis to 

TCE. EPA also plans to consider SACC 

feedback and make decisions regarding 

how to build upon the screening 

approach so that EPA can more 

accurately assess and quantify general 

population exposures in upcoming risk 

evaluations, such as for the 1,4-dioxane 

supplement, the forthcoming 20 High 

Priority Substances, and manufacturerrequested risk evaluations. For TCE, 

EPA is including a multi-year 

assessment of the ambient air pathway 

in light of peer review comments on the 

initial methodology. 

EPA interpreted risk estimates in 

relation to the benchmark values 

corresponding to each hazard value. In 

the case of acute and chronic exposures 

to drinking water, as well as incidental 

oral and incidental dermal exposures in 

ambient waters, potential for noncancer 

risk was identified by those risk 

estimates below the benchmark MOE for 

acute and chronic non-cancer 

immunotoxicity and developmental 

endpoints. While cancer risks were not 

assessed for incidental oral or dermal 

exposure pathways, cancer risks were 

assessed for inhalation exposures. For 

cancer, potential for risk was identified 

by those risk estimates above the 

benchmark. For the air pathway, EPA’s 

analysis identified risk estimates that 

did not exceed the benchmarks for at 

least two non-cancer endpoints 

(developmental and immunotoxicity), 

and risk estimates above the benchmark 

for cancer. Estimates of cancer risk to 

fenceline communities were calculated 

and compared to 1 × 10¥6 as a 

benchmark value for cancer risk in 

fenceline communities. Cancer 

benchmarks used by EPA and other 

regulatory agencies in interpreting the 

significance of cancer risks range from 

1 in 1,000,000 to 1 in 10,000 (i.e., 1 × 

10¥6 to 1 × 10¥4) depending on the 

subpopulation exposed (see, e.g., EPA’s 

interpretation set forth in the Federal 

Register of September 14, 1989 (54 FR 

38044) which discusses the use of 

benchmarks for purposes of assessing 

exposures to individuals living in the 

vicinity of air emissions sources under 

section 112 of the Clean Air Act (CAA); 

see also EPA’s interpretation of the 

upper bound of acceptable risk and the 

preferred benchmark described in the 

Letter of Concern regarding EPA 

Complaint Nos. 01R–22–R6, 02R–22– 

R6, and 04R–22–R6 (Ref. 76, see page 3 


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footnotes 5 and 6, and page 6)). While 

EPA is unable to formally determine, 

based on the screening level fenceline 

analysis, whether risks to the general 

population drive the unreasonable risk, 

as a matter of risk management policy 

EPA considers the range of 1 in 

1,000,000 to 1 in 10,000 (i.e., 1 × 10¥6

to 1 × 10¥4) as the appropriate values 

for interpreting the significance of 

increased cancer risk for the general 

population, including fenceline 

communities. It is preferable to have the 

air or water concentrations of TCE result 

in an increased cancer risk closer to the 

1 in 1,000,000 (1 × 10¥6) value, with the 

1 in 10,000 (1 × 10¥4) value generally 

representing the upper bound of 

acceptability for estimated excess cancer 

risk. Benchmark values help inform 

decisions regarding the significance of 

risk, and the Agency considers a 

number of other factors when 

determining whether risks are 

significant, such as the endpoint under 

consideration, the reversibility of effect, 

and exposure-related considerations 

(e.g., duration, magnitude, or frequency 

of exposure, or population exposed). 

In this unit, EPA presents the results 

of its ambient air and water pathways 

fenceline analysis and the uncertainties 

associated with the analysis. Overall, 

EPA’s fenceline analysis for the air and 

water pathways for TCE did not allow 

EPA to rule out unreasonable risk to 

fenceline communities with confidence. 

Additionally, based on the fenceline 

analysis for the ambient air and water 

pathways for TCE, including the 

strengths, limitations, and uncertainties 

associated with the information used to 

inform the analysis, EPA is unable to 

determine with this analysis whether 

those risks drive the unreasonable risk 

of injury to health presented by TCE. 

EPA also describes how the proposal to 

prohibit the manufacturing (include 

importing), processing, and distribution 

in commerce of TCE for all uses of TCE 

(including all consumer use) is expected 

to eliminate the potential risks 

identified in the screening analysis to 

any general population or fenceline 

communities close to facilities engaging 

in TCE use. This unit also describes 

how EPA believes the proposed WCPP 

requirements may reduce exposures to 

the general population for facilities 

identified in the fenceline analysis with 

expected exposures to fenceline 

communities that are associated with 

conditions of use for which EPA is 

proposing longer compliance 

timeframes (including under a TSCA 

section 6(g) time-limited exemption). 

EPA therefore does not intend to revisit 

the air or water pathways for TCE as 

part of a supplemental risk evaluation. 

1. Ambient Air Pathway Analysis 

The ambient air fenceline analysis 

was divided into three components: (1) 

A single-year ambient air analysis, (2) A 

multi-year ambient air analysis, and (3) 

A land use analysis. EPA conducted an 

ambient air analysis for a single year 

and multiple years to assess where 

estimates exceeded the one in a million 

risk estimates for non-cancer and cancer 

risk for real and generic, or modeled, 

facilities at multiple distances. After 

doing an initial screen (the single year 

ambient air screening analysis) that did 

not rule out unreasonable risk, EPA 

conducted additional analyses (the 

multi-year ambient air analysis) from 

which it derived risk estimates that, 

with a small number of exceptions, are 

within the cancer benchmarks used by 

EPA and other regulatory agencies of 1 

in 10,000 to 1 in 1,000,000. The single 

year ambient air screening analysis and 

the multi-year ambient air analysis 

allow EPA to mathematically calculate a 

cancer risk in fenceline communities. 

The Agency then conducted a land use 

analysis as part of both the single-year 

and multi-year analyses to determine if 

EPA could reasonably expect an 

exposure to fenceline communities to 

occur within the modeled distances for 

facilities where there was an indication 

of risk. This review consisted of a visual 

analysis using aerial imagery and 

interpreting land/use zoning practices 

around each facility to identify where 

residential, industrial/commercial 

businesses, or other public spaces are 

present within those radial distances 

indicating risk (as opposed to 

uninhabited areas), as well as whether 

the radial distances lie outside the 

boundaries of the facility. 

There are some uncertainties 

associated with the fenceline analysis 

for the air pathway for TCE. The TRI 

dataset used for the single- and the 

multi-year fenceline analysis and land 

use analysis does not include actual 

release point locations, which can affect 

the estimated concentrations at varying 

distances modeled. To identify the 

release location for each facility, EPA 

used a local-coordinate system based on 

latitude/longitude coordinates reported 

in TRI. The latitude/longitude 

coordinates may represent the mailing 

address location of the office building 

associated with a very large facility or 

some other area of the facility rather 

than the actual release location (e.g., a 

specific process stack). This discrepancy 

between the coordinates reported in TRI 

and the actual release point could result 

in an exposure concentration that does 

not represent the actual distance where 

fenceline communities may be exposed. 

The fenceline analysis also evaluated 

the most ‘‘conservative exposure 

scenario’’ that consists of a facility that 

operates year-round (365 days per year, 

24 hours per day, 7 days per week) in 

a South Coastal meteorologic region and 

a rural topography setting (Ref. 77). 

Therefore, the modeled exposures to 

people who live in fenceline 

communities may be overestimated if 

there are fewer exposure days per year 

or hours per day. 

Additionally, the ambient air 

fenceline analysis (as well as the water 

pathway analysis, described in Unit 

VII.A.2.) organizes facilities and 

associated risks by OES and generally 

crosswalks each OES with the 

associated condition of use of TCE (Ref. 

77). For some OES, EPA identified the 

associated conditions of use to the 

category level in the November 2020 

Risk Evaluation for TCE, but, for the air 

pathway, was unable to identify the 

conditions of use to the subcategory 

level due to limited information on 

activities and use of TCE reported under 

TRI. Therefore, some OES indicating 

increased risk from ambient air 

exposures to TCE in the air fenceline 

analysis may be associated with one or 

more conditions of use of TCE. 

EPA’s analysis included inhalation 

hazard values for cancer and non-cancer 

risk (acute and chronic immunological 

and developmental endpoints). Because 

risk estimates did not exceed the 

benchmarks for any risks of non-cancer 

effects, the results presented focus on 

cancer risks. EPA’s single year fenceline 

analysis for the ambient air pathway, 

based on methods presented to the 

SACC, evaluated TCE releases reported 

to TRI over the 2019 reporting year. This 

single-year fenceline analysis identified 

risk estimates exceeding one in a 

million for cancer risk for 99 of the 133 

facilities (including generic, or modeled, 

facilities) at multiple distances, 

representing 13 OES. While the analysis 

identified facilities with some 

indication of releases and potential 

exposure with associated increased 

cancer risk that exceeds one in a million 

at a distance of 100 meters or more from 

the releasing facility, the analysis did 

not identify any facilities exceeding 1 in 

10,000; the highest risk estimate is in 

the 1 in 100,000 range. Separately, 

following SACC feedback, EPA applied 

a slightly modified pre-screening 

methodology to evaluate 6 years of TCE 

release data (2015 through 2020 TRI 

data as well as the 6-year average of that 

data) rather than a single year of data for 

facilities with reported releases in TRI. 

Although the multi-year analysis 


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identified several additional facilities 

with risk estimates above one in a 

million for cancer farther out when 

compared to the single year analysis or 

that were not captured in the single-year 

analysis, the results of the overall risk 

profiles (i.e., OES and corresponding 

conditions of use with risk estimates 

above one in a million for cancer at the 

distances evaluated) indicated a higher 

risk profile than the single year analysis: 

the multi-year analysis identified 217 

facilities and found risk estimates above 

one in a million for cancer in 133 of 

those facilities at a distance of 100 

meters from the releasing facility. Based 

on the multi-year analysis, 58 of these 

133 facilities either had risks above one 

in a million for cancer at distances 

farther out than 100 meters when 

compared to the single year analysis or 

are facilities that were not captured in 

the single-year analysis (e.g., did not 

report in 2019 TRI). The analysis did 

not identify any facilities exceeding 1 in 

10,000 at a distance greater than 100 

meters; the highest risk estimate is in 

the 1 in 100,000 range (Ref. 77). 

EPA conducted a land use analysis to 

determine if EPA can reasonably expect 

an exposure to fenceline communities to 

occur within the modeled distances for 

facilities where there was an indication 

of risk in the single year or multi-year 

fenceline analysis. This review 

consisted of a visual analysis using 

aerial imagery and interpreting land/use 

zoning practices around the facility to 

identify where residential, industrial/ 

commercial businesses, or other public 

spaces are present within those radial 

distances indicating risk (as opposed to 

uninhabited areas), as well as whether 

the radial distances lie outside the 

boundaries of the facility. The land use 

analysis of the 85 facilities with risk 

indicating risk in the single-year 

fenceline analysis identified 69 facilities 

with expected exposure to fenceline 

communities. The land use analysis of 

the 58 facilities indicating risk in the 

multi-year fenceline analysis (i.e., 

facilities where risk estimates were 

above one in a million for cancer at 

distances farther out when compared to 

the single-year analysis or facilities that 

were not captured in the single year 

analysis) identified a total of 55 

facilities with expected exposure to 

fenceline communities. Those facilities 

represent 10 OES and include: 

degreasing (batch open-top degreasing; 

batch closed-loop degreasing; 

conveyorized vapor degreasing; web 

vapor degreasing; cold cleaning); 

formulation of aerosol and non-aerosol 

products; industrial processing aid; 

manufacturing; metalworking fluids; 

other industrial uses; process solvent 

recycling and worker handling of 

wastes; processing as a reactant; 

recycling and disposal; and repackaging 

(Ref. 77). 

Under the proposed regulatory action 

described in Unit V.A., each of the 

conditions of use that indicate risk 

relative to the one in a million cancer 

risk estimate would ultimately be 

prohibited, many of them within one 

year. As a result, exposures to any 

fenceline communities from these 

facilities would be eliminated under the 

prohibitions in this proposed 

rulemaking. The risks to fenceline 

communities from exposure further 

strengthens the impetus for EPA’s 

prohibition of TCE. 

EPA recognizes that there are some 

facilities for which risks are indicated 

that may exceed the one in a million 

risk estimate and with expected 

exposure to fenceline communities that 

may be associated with the following 

conditions of use that EPA is proposing 

to prohibit under longer compliance 

timeframes: degreasing (batch open-top 

degreasing; batch closed-loop 

degreasing; conveyorized vapor 

degreasing; web vapor degreasing; cold 

cleaning); industrial processing aid; 

manufacturing; and processing as a 

reactant. For processing as a reactant, 

EPA notes that while the analysis 

identified facilities with some 

indication of releases and potential 

exposure with associated increased 

cancer risk that exceeds one in a million 

at a distance of 100 meters from the 

releasing facility, the analysis did not 

identify any facilities exceeding 1 in 

10,000; the highest risk estimate is in 

the 1 in 100,000 range. For this and 

other conditions of use that may be 

associated with facilities that indicate 

risks with expected exposure to 

fenceline communities, the proposed 

rule would require strict workplace 

exposure controls via implementation of 

a WCPP as described in Unit V.A.2., 

until the prohibition compliance date. 

Under the proposed WCPP 

requirements, facilities would need to 

monitor indoor TCE air concentrations, 

which would allow facilities to better 

understand and manage the total 

releases of TCE. Furthermore, under the 

WCPP requirements, facilities would 

need to evaluate controls to determine 

how to reduce releases and exposures to 

potentially exposed persons in the 

workplace. EPA anticipates that this 

analysis would help facilities to 

determine the most effective ways to 

reduce exposures (including possible 

engineering controls or elimination/ 

substitution of TCE) and whether those 

methods for exposure reduction impact 

releases, and therefore may reduce the 

overall risk to fenceline communities 

from facilities permitted to use TCE 

under a longer compliance timeframe 

until the prohibition compliance date. 

As further detailed in Unit V.A.2.b.iii., 

EPA is also requesting comment on 

whether industry anticipates increased 

releases of TCE to outdoor air associated 

with the implementation of the WCPP. 

In order to avoid unintended increases 

in exposures to people from TCE 

emissions to ambient air, EPA requests 

comment on whether owners and 

operators should be required to attest in 

their exposure control plan that 

engineering controls selected do not 

increase emissions of TCE to ambient air 

outside of the workplace and document 

in their exposure control plan whether 

additional equipment was installed to 

capture emissions of TCE to ambient air. 

EPA requests comment on how such a 

requirement could impact the 

availability, feasibility, or cost of 

engineering controls as a means to 

reduce workplace exposures to or below 

the proposed ECEL. EPA is also 

soliciting comment on the frequency 

and nature of air monitoring EPA 

should consider including as 

requirements in the final rule. 

In the instances where efforts to 

reduce exposures in the workplace to 

levels below the ECEL could lead to 

adoption of engineering controls that 

ventilate more TCE outside, EPA 

believes this potential exposure would 

be limited as a result of the existing 

NESHAP for TCE for these conditions of 

use under the CAA. Applicable 

NESHAP include: 40 CFR part 63, 

subpart F, Synthetic Organic Chemical 

Manufacturing Industry; 40 CFR part 63, 

subpart DD, Off-Site Waste and 

Recovery Operations; 40 CFR part 63, 

subpart VVV, Publicly Owned 

Treatment Works; 40 CFR part 63, 

subpart VVVVVV, Chemical 

Manufacturing Area Sources; 40 CFR 

part 63, subpart GG, Aerospace 

Manufacturing and Rework Facilities; 

40 CFR part 63, subpart T, Halogenated 

Solvent Cleaning, which impose 

emission standards and work practice 

requirements reflecting maximum 

achievable control technology and 

generally available control technology. 

The CAA required residual risk reviews 

for standards reflecting maximum 

achievable control technology, and 

technology reviews are required every 8 

years for all NESHAP. 

2. Water Pathway Analysis 

The methods used to assess the water 

pathways (i.e., drinking water or 

incidental dermal or oral exposure in 

ambient waters) for TCE are consistent 


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with the methods described in the 2022 

Fenceline report that underwent peer 

review (Ref. 78). Briefly, EPA assessed 

exposure via drinking water, incidental 

oral ingestion, and incidental dermal 

contact based on modeled stream and 

water body concentrations, using 

information described and documented 

in the November 2020 TCE Risk 

Evaluation (Ref. 1). This included the 

amount of chemical released to 

wastewater, the release days per year 

(with a high end of 250 to 365 days per 

year, and a low end of 20 days per year), 

the percent removal from wastewater 

treatment, and site-specific stream flow 

or dilution factors. 

There are some uncertainties 

associated with the fenceline analysis 

for the water pathway for TCE. For the 

ambient water pathway, exposures were 

evaluated based on modeled stream and 

water body concentrations using E– 

FAST 2014, which is subject to a 

number of uncertainties. For example, 

stream flow data available in the E– 

FAST 2014 at the time of this analysis 

were 15 to 30 years old and therefore 

may not represent current conditions at 

a particular location. Additionally, E– 

FAST 2014 estimates waterbody surface 

water concentrations at the point of 

release without considering certain 

post-release environmental fate of 

degradation processes, which may lead 

to higher predicted surface water 

concentrations. Similarly, estimated 

drinking water exposures are based on 

assumptions that an individual is 

exposed to potential waterbody 

concentrations at the point of release 

without any potential for transport, 

dilution, or treatment and therefore 

represent higher-end estimates of 

possible drinking water exposures (Ref. 

79). An additional uncertainty relates to 

the crosswalk of a given facility to a 

particular OES and then condition of 

use; as described in Unit VII.A.2., due 

to limited information on activities and 

use of TCE in the data sources available, 

there is uncertainty if the facilities 

associated with a specific OES were 

correctly cross-walked to the 

appropriate condition of use, or whether 

some OESs indicating increased risk 

from water exposures to TCE should be 

associated with more than one 

condition of use. 

EPA’s screening level analysis for the 

water pathway for TCE, based on 

methods presented to the SACC, found 

potential risks from several OES from 

exposure to drinking water, incidental 

dermal or incidental oral exposure in 

ambient waters. The estimated exposure 

values for the screening level assessed 

water pathway resulted in estimated 

acute noncancer, chronic noncancer, or 

cancer risk for relative to their 

respective benchmark values for various 

evaluated OESs (Ref. 79). 

The drinking water analysis modeled 

a total of 101 releases across all OES for 

the 20-day release scenario, and 

modeled a total of 103 releases for the 

maximum days of release scenario. For 

the drinking water exposure, risks 

relative to the benchmark for the acute 

non-cancer developmental endpoint for 

both the 20-day and maximum days of 

release scenarios for at least one facility 

in each of the following OES: 

Manufacturing; Processing as a 

Reactant; Degreasing; Repackaging; 

Process Solvent Recycling; Adhesives, 

Sealants, Paints and Coatings; Industrial 

Processing Aid, and Other Industrial 

Uses. For drinking water exposures, at 

least one facility indicated an increased 

cancer risk at or above 1 in 1,000,0000 

(but less than 1 in 100,000) for both the 

20-day and maximum days of release 

scenarios for the Degreasing and 

Repackaging OES. EPA did not identify 

source water drinking water intakes for 

public drinking water systems within 10 

miles downstream of facilities with 

known locations discharging to 

identifiable waterbodies. No risks 

relative to acute or chronic exposures 

for the immune endpoint or for chronic 

exposures for the developmental 

endpoint benchmarks were identified 

for any OES for drinking water 

exposures; for the immune endpoint, 

estimated margins of exposure were at 

least 4-fold higher than benchmarks. 

For the incidental oral exposure in 

ambient water, a total of 113 releases 

were modeled across all OES for the 20- 

day release scenario, and a total of 115 

releases were modeled across all OES 

for the maximum days of release 

scenario. Risks relative to the 

benchmark were identified for at least 

one facility for the acute non-cancer 

developmental endpoint under the 20- 

day scenarios for Processing as a 

Reactant; Degreasing; Repackaging; 

Process Solvent Recycling; Adhesives, 

Sealants, Paints, and Coatings; and 

Other Industrial Uses OESs were 

identified for the 20-days of release 

scenario. For the maximum days of 

release scenario, risks relative to the 

benchmark for the acute developmental 

endpoint were identified for: Processing 

as a Reactant and Degreasing. For the 

immune endpoint, no risks were 

identified relative to the acute 

exposures benchmark. For chronic 

scenarios, risk was identified relative to 

the benchmarks for both the immune 

and developmental endpoints for the 

20-day and maximum days of release 

scenarios. Specifically, at least one 

facility in the Degreasing OES was 

identified as showing risk relative to 

both endpoints for the maximum risk 

scenarios for both types of releases (20- 

day and maximum), and at least one 

facility in the Processing as a Reactant 

OES was identified as showing risk 

relative to the developmental endpoint 

for both the 20-day and maximum 

release scenarios. 

Similarly, for the incidental dermal 

exposure in ambient waters pathway, a 

total of 113 releases were modeled 

across all OES for the 20-day release 

scenario, and a total of 115 releases 

were modeled across all OES for the 

maximum days of release scenario. For 

both incidental oral and incidental 

dermal exposures, EPA did not assess 

cancer risk because repeated exposures 

are not expected to continue across a 

lifetime. For acute scenarios, risk was 

identified for at least one facility 

relative to both the immune and 

developmental endpoints for the 20-day 

and maximum release scenarios. For 20- 

day release scenarios, the immune 

endpoint had identified risk relative to 

the benchmark for at least one facility in 

the Degreasing OES, while the 

developmental endpoint had identified 

risk relative to the benchmark for the at 

least one facility in the following OES: 

Processing as a Reactant; Degreasing; 

Repackaging; Process Solvent Recycling; 

Adhesives, Sealants, Paints, and 

Coatings; Industrial Processing Aid; and 

Other Industrial Uses. For the maximum 

days of release scenarios, risk relative to 

the developmental endpoint was 

identified for at least one facility in the 

Processing as a Reactant and the 

Degreasing OES. For chronic scenarios, 

risk was identified relative to both the 

immune and developmental endpoint 

benchmarks for at least one facility for 

both the 20-day and maximum days of 

release scenarios. For 20-day release 

scenarios, the Processing as a Reactant 

and Degreasing OES had risks identified 

relative to the immune and 

developmental endpoint benchmarks; 

for the maximum days release scenarios, 

the Processing as a Reactant and 

Degreasing OES had risks identified 

relative to the immune and 

developmental endpoint benchmarks. 

Overall, for the analysis of the water 

pathway, EPA identified potential risks 

that exceed the benchmark for noncancer endpoints from several facilities, 

representing benchmark exceedances 

between 1 and 10 OES, depending on 

whether the drinking water, incidental 

oral, or incidental dermal exposures are 

considered. In each case for the 

screening level analysis, risks were 

identified only for the maximum risk 

scenarios (or facilities with the highest 

reported results), and for a relatively 


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small number of facilities. In instances 

where a facility may be engaging in a 

condition of use with a longer phaseout, EPA notes that in no instances did 

EPA identify drinking water intakes 

within 10 miles of a discharging facility, 

and emphasizes that the scenarios 

analyzed include significant 

uncertainties and assumptions within 

the high-end risk estimates due to 

reliance on the highest-reported results 

from several facilities (Ref. 79). 

Regarding cancer risks, while the 

analysis identified facilities with some 

indication of releases and potential 

drinking water exposure with associated 

increased cancer risk that exceeds more 

than 1 in 1,000,000, the analysis did not 

identify any facilities exceeding more 

than 1 in 10,000; the highest potential 

risk estimate is in the 1 in 100,000 range 

(Ref. 79). 

Under the proposed regulatory action 

described in Unit V.A., all conditions of 

use would ultimately be prohibited and 

so any potential risk indicated by this 

screening analysis would be eliminated. 

In particular, under the proposed 

regulatory action the disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works would be prohibited. The risks to 

fenceline communities from exposure 

through water further strengthen the 

impetus for EPA’s prohibition of TCE. 

EPA therefore does not intend to revisit 

the water pathway for TCE as part of a 

supplemental risk evaluation. 

B. Environmental Effects of TCE and the 

Magnitude of Exposure of the 

Environment to TCE 

EPA’s analysis of the environmental 

effects of TCE and the magnitude of 

exposure of the environment to TCE are 

in the 2020 Risk Evaluation for TCE 

(Ref. 1). The unreasonable risk 

determination for TCE is based solely on 

risks to human health (Ref. 2); based on 

the TSCA 2020 Risk Evaluation for TCE, 

EPA determined that exposures to the 

environment did not drive the 

unreasonable risk. A summary is 

presented here. 

For all conditions of use, amphibian, 

fish, and aquatic invertebrate acute and 

chronic exposures to TCE do not drive 

the unreasonable risk. To characterize 

the exposure to TCE by aquatic 

organisms, EPA assessed environmental 

exposures derived from predicted and 

measured concentrations of TCE in 

surface water in the U.S. Specifically, 

the aquatic exposures associated with 

the industrial and commercial 

conditions of use were predicted 

through modeling, and the aquatic 

exposure assessment also includes an 

analysis of collected measured surface 

water concentrations from monitoring 

data. EPA considered the biological 

relevance of the species to determine 

the concentrations of concern for the 

location of surface water concentration 

data to produce risk quotients, as well 

as frequency and duration of the 

exposure. EPA determined that the 

evaluation does not support an 

unreasonable risk determination to 

aquatic organisms. 

The toxicity of TCE to sedimentdwelling invertebrates is similar to the 

toxicity to aquatic invertebrates. TCE is 

expected to remain in aqueous phases 

and not adsorb to sediment due to its 

water solubility and low partitioning to 

organic matter. TCE has relatively low 

partitioning to organic matter and 

biodegrades slowly, so TCE 

concentrations in sediment pore water 

are expected to be similar to the 

concentrations in the overlying water or 

lower in the deeper part of sediment 

where anaerobic condition prevails. 

Thus, the TCE detected in sediments is 

likely from the pore water. Therefore, 

for sediment-dwelling organisms, the 

risk estimates, based on the highest 

ambient surface water concentration, do 

not support an unreasonable risk 

determination to sediment-dwelling 

organisms from acute or chronic 

exposures. 

For terrestrial organisms, TCE 

exposure is expected to be low since 

physical-chemical properties do not 

support an exposure pathway through 

water and soil pathways to these 

organisms. Therefore, for terrestrial 

organisms, the risk estimates, based on 

the EPA 2003 Guidance for Ecological 

Soil Screening Levels, do not support an 

unreasonable risk determination from 

acute or chronic exposures. 

C. Benefits of TCE for Various Uses 

TCE has a wide range of uses, 

including as an intermediate during the 

manufacture of refrigerants, specifically 

HFC–134a, and is also used as a solvent, 

frequently in cleaning and degreasing 

(including spot cleaning, vapor 

degreasing, cold cleaning, and aerosol 

degreasing). A variety of consumer and 

commercial products use TCE as 

adhesives and sealants, in paints and 

coatings, and in other miscellaneous 

products. TCE is subject to Federal and 

State regulations and reporting 

requirements. 

The largest uses of TCE, by 

production volume, are for processing 

as a reactant/intermediate as well as 

aerosol and vapor degreasing uses. 

Based on the 2020 Risk Evaluation for 

TCE, over 84% of the production 

volume of TCE is processed as a 

reactant/intermediate, the majority of 

the volume is for TCE processed as an 

intermediate in the production of HFC– 

134a, a refrigerant widely used in a 

broad range of applications. The second 

largest use of TCE is in industrial and 

commercial uses for aerosol and vapor 

degreasing. TCE is a relatively 

inexpensive solvent useful for cleaning 

contaminated metal parts and other 

fabricated materials (Ref. 3). 

TCE has many other uses, which, 

based on the 2020 Risk Evaluation for 

TCE, collectively constitute about 1% of 

the production volume (Ref. 1). In 

battery separator manufacturing, TCE is 

used as an extraction solvent to produce 

the desired porosity in lead-acid and 

lithium battery separators, which are 

essential to power vehicles and systems 

in the U.S. supply chain. 

D. Reasonably Ascertainable Economic 

Consequences of the Proposed Rule 

1. Likely Effect of the Rule on the 

National Economy, Small Business, 

Technological Innovation, the 

Environment, and Public Health 

The reasonably ascertainable 

economic consequences of this 

proposed rule include several 

components, all of which are described 

in the Economic Analysis for this 

proposed rule (Ref. 3). With respect to 

the anticipated effects of this proposed 

rule on the national economy, EPA 

considered the number of businesses 

and workers that would be affected and 

the costs and benefits to those 

businesses and workers and did not find 

that there would be an impact on the 

national economy (Ref. 3). The 

economic impact of a regulation on the 

national economy becomes measurable 

only if the economic impact of the 

regulation reaches 0.25% to 0.5% of 

Gross Domestic Product (GDP) (Ref. 80). 

Given the current (real) GDP [of $60.4 

trillion (2022)], this is equivalent to a 

cost of $151 billion to $302 billion. 

Therefore, because EPA has estimated 

that the monetized cost of the proposed 

rule would range from $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, EPA has concluded that 

this action is highly unlikely to have 

any measurable effect on the national 

economy (Ref. 3). EPA does not have 

data to quantify employment impacts of 

the proposed rule, and large 

employment impacts are not expected. 

Instead, workers currently using TCE 

are expected to continue employment 

while shifting away from TCE use and 

towards alternatives. However, EPA 

acknowledges that transitional 

employment impacts may be 


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experienced by some workers at 

facilities that opt to close or shift 

operations abroad instead of complying 

with requirements at the facilities 

currently using TCE. EPA considered 

the employment impacts of this 

proposed rule, and found that the 

direction of change in employment is 

uncertain, but EPA expects the shortterm and longer-term employment 

effects to be small. 

Of the small businesses potentially 

impacted by this proposed rule, 99.1% 

are expected to have impacts of less 

than 1% to their firm revenues, 0.5% 

are expected to have impacts between 1 

and 3% to their firm revenues, and 

0.4% are expected to have impacts 

greater than 3% to their firm revenues. 

The largest segment of businesses that 

would be affected by this regulation are 

commercial users of liquid and aerosol 

degreasers. Costs of alternatives were 

found to be both higher and lower than 

products containing TCE. For most 

product types, alternatives with similar 

efficacy are available with costs that 

both lower and higher than TCE 

products. However, there may be some 

applications where TCE is more 

effective, reducing labor time and wait 

time, and or where extensive safety 

testing might be required. EPA was 

unable to quantify these costs. 

With respect to this proposed rule’s 

effect on technological innovation, EPA 

expects this action to spur more 

innovation than it will hinder. A 

prohibition or significant restriction on 

the manufacture, processing, and 

distribution in commerce of TCE for 

uses covered in this proposed rule may 

increase demand for safer chemical 

substitutes. This proposed rule is not 

likely to have significant effects on the 

environment because TCE does not 

present an unreasonable risk to the 

environment, though this proposed rule 

does present the potential for small 

reductions in air emissions and soil 

contamination associated with improper 

disposal of products containing TCE. 

The effects of this proposed rule on 

public health are estimated to be 

positive, due to the reduced risk of 

cancer and other non-cancer endpoints 

from exposure to TCE. 

2. Costs and Benefits of the Proposed 

Regulatory Action and of the One or 

More Primary Alternative Regulatory 

Actions Considered by the 

Administrator 

The costs and benefits that can be 

monetized for this proposed rule are 

described at length in in the Economic 

Analysis (Ref. 3). The monetized costs 

for this proposed rule are estimated to 

range from $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. The monetized 

benefits are estimated to range from 

$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. 

EPA considered the estimated costs to 

regulated entities as well as the cost to 

administer and enforce alternative 

regulatory actions. The primary 

alternative regulatory action is 

described in detail in Unit V.B. The 

estimated annualized costs of the 

alternative regulatory action are $34.4 

million at a 3% discount rate and $41.2 

million at a 7% discount rate over 20 

years (Ref. 3). The monetized benefits of 

this alternative regulatory action are 

estimated to range from $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 over 20 years (Ref. 3). 

This proposal is expected to achieve 

health benefits for the American public, 

some of which can be monetized and 

others that, while tangible and 

significant, cannot be monetized. EPA 

believes that the balance of costs and 

benefits of this proposal cannot be fairly 

described without considering the 

additional, non-monetized benefits of 

mitigating the non-cancer adverse 

effects. These effects may include 

neurotoxicity, kidney toxicity, liver 

toxicity, immunological and 

hematological effects, reproductive 

effects, and developmental effects. The 

multitude of adverse effects from TCE 

exposure can profoundly impact an 

individual’s quality of life, as discussed 

in Unit II.A. (overview), Unit III.B.2. 

(description of the unreasonable risk), 

Unit V.A. (discussion of the health 

effects), and the 2020 Risk Evaluation 

for TCE. Chronic adverse effects of TCE 

exposure include both cancer and the 

non-cancer effects listed in this 

paragraph. Acute effects of TCE 

exposure could be experienced for a 

shorter portion of life but are 

nevertheless significant in nature. The 

incremental improvements in health 

outcomes achieved by given reductions 

in exposure cannot be quantified for 

non-cancer health effects associated 

with TCE exposure, and therefore 

cannot be converted into monetized 

benefits. The qualitative discussion 

throughout this rulemaking and in the 

Economic Analysis highlights the 

importance of these non-cancer effects. 

These effects include willingness-to-pay 

to avoid illness, which includes cost of 

illness and other personal costs such as 

pain and suffering. Considering only 

monetized benefits underestimates the 

impacts of TCE adverse outcomes and 

therefore underestimates the benefits of 

this proposed rule. 

3. Cost Effectiveness of the Proposed 

Regulatory Action and of the 1 or More 

Primary Alternative Regulatory Actions 

Considered by the Administrator 

Cost effectiveness is a method of 

comparing certain actions in terms of 

the expense per item of interest or goal. 

A goal of this proposed regulatory 

action is to achieve the risk reduction 

standard in a [more] cost-effective 

manner, with estimated [lower] costs 

and [higher] net benefits, than other 

considered alternative regulatory 

actions (Ref. 3). The proposed regulatory 

action would cost $6.8–7.7 million per 

potential prevented cancer case while 

the primary alternative regulatory action 

would cost $7.1–8.0 million (using the 

3% discount rate) to achieve the same 

goals. While the primary alternative 

regulatory action is lower in cost 

compared to the proposed regulatory 

action, the difference is small (Ref. 3). 

VIII. TSCA Section 9 Analysis, Section 

14, and Section 26 Considerations 

A. TSCA Section 9(a) Analysis 

TSCA section 9(a) provides that, if the 

Administrator determines, in the 

Administrator’s discretion, that an 

unreasonable risk may be prevented or 

reduced to a sufficient extent by an 

action taken under a Federal law not 

administered by EPA, the Administrator 

must submit a report to the agency 

administering that other law that 

describes the risk and the activities that 

present such risk. TSCA section 9(a) 

describes additional procedures and 

requirements to be followed by EPA and 

the other Federal agency following 

submission of any such report. As 

discussed in this unit, for this proposed 

rule, the Administrator proposes to 

exercise his discretion not to determine 

that the unreasonable risk from TCE 

under the conditions of use may be 

prevented or reduced to a sufficient 

extent by an action taken under a 

Federal law not administered by EPA. 

In addition, TSCA section 9(d) 

instructs the Administrator to consult 

and coordinate TSCA activities with 

other Federal agencies for the purpose 

of achieving the maximum enforcement 

of TSCA while imposing the least 

burdens of duplicative requirements. 

For this proposed rule, EPA has and 

continues to coordinate with 

appropriate Federal executive 

departments and agencies including 

OSHA and the Consumer Product Safety 

Commission (CPSC), to, among other 

things, identify their respective 


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authorities, jurisdictions, and existing 

laws with regard to TCE, which are 

summarized in this unit. 

OSHA requires that employers 

provide safe and healthful working 

conditions by setting and enforcing 

standards and by providing training, 

outreach, education and assistance. As 

described in Unit II.C., OSHA, in 1971, 

established a PEL for TCE of 100 ppm 

of air as an 8-hour TWA with an 

acceptable ceiling concentration of 200 

ppm and an acceptable maximum peak 

above the acceptable ceiling 

concentration for an eight-hour shift of 

300 ppm, maximum duration of 5 

minutes in any 2 hours. However, the 

exposure limits established by OSHA 

are higher than the exposure limit that 

EPA determined would be sufficient to 

address the unreasonable risk identified 

under TSCA from occupational 

inhalation exposures associated with 

certain conditions of use. Gaps exist 

between OSHA’s authority to set 

workplace standards under the OSH Act 

and EPA’s obligations under TSCA 

section 6 to eliminate unreasonable risk 

presented by chemical substances under 

the conditions of use. Health standards 

issued under section 6(b)(5) of the OSH 

Act must reduce significant risk only 

‘‘to the extent feasible.’’ 29 U.S.C. 

655(b)(5). To set PELs for chemical 

exposure, OSHA must first establish 

that the new standards are economically 

and technologically feasible (79 FR 

61384 and 61387, Oct. 10, 2014). But 

under TSCA section 6(a), EPA’s 

substantive burden is to demonstrate 

that, as regulated, the chemical 

substance no longer presents an 

unreasonable risk, with unreasonable 

risk being determined without 

consideration of costs or other nonrisk 

factors. Thus, if OSHA were to initiate 

a new action to lower its PEL, the 

difference in standards between the 

OSH Act and TSCA may well result in 

the OSHA PEL being set at a higher 

level than the exposure limit that EPA 

determined would be sufficient to 

address the unreasonable risk under 

TSCA. 

In addition, OSHA may set exposure 

limits for workers, but its authority is 

limited to the workplace and does not 

extend to consumer uses of hazardous 

chemicals, and thus OSHA cannot 

address the unreasonable risk from TCE 

under all of its conditions of use, which 

include consumer uses. OSHA also does 

not have direct authority over State and 

local employees, and it has no authority 

over the working conditions of State and 

local employees in States that have no 

OSHA-approved State Plan under 29 

U.S.C. 667. 

CPSC, under authority provided to it 

by Congress in the CPSA, protects the 

public from unreasonable risk of injury 

or death associated with the use of 

consumer products. Under the CSPA, 

CPSC has the authority to regulate TCE 

in consumer products, but not in other 

sectors such as automobiles, industrial 

and commercial products, or aircraft for 

example (Ref. 81). Further, a consumer 

product safety rule under the CPSA 

must include a finding that ‘‘the benefits 

expected from the rule bear a reasonable 

relationship to its costs,’’ 15 U.S.C. 

2058(f)(3)(E), whereas EPA must apply 

TSCA risk management requirements to 

the extent necessary so that the 

chemical no longer presents 

unreasonable risk and only consider 

costs and benefits of the regulatory 

action to the extent practicable, 15 

U.S.C. 2605(a), (c)(2). Additionally, the 

2016 amendments to TSCA reflect 

Congressional intent to ‘‘delete the 

paralyzing ‘least burdensome’ 

requirement,’’ 162 Cong. Rec. S3517 

(June 7, 2016), a reference to TSCA 

section 6(a) as originally enacted, which 

required EPA to use ‘‘the least 

burdensome requirements’’ that protect 

‘‘adequately’’ against unreasonable risk, 

15 U.S.C. 2605(a) (1976). However, a 

consumer product safety rule under the 

CPSA must impose ‘‘the least 

burdensome requirement which 

prevents or adequately reduces the risk 

of injury for which the rule is being 

promulgated.’’ 15 U.S.C. 2058(f)(3)(F). 

Analogous requirements, also at 

variance with recent revisions to TSCA, 

affect the availability of action CPSC 

may take under the Federal Hazardous 

Substances Act (FHSA) relative to 

action EPA may take under TSCA. 15 

U.S.C. 1262. 

EPA therefore concludes that TSCA is 

the only regulatory authority able to 

prevent or reduce unreasonable risk of 

TCE to a sufficient extent across the 

range of conditions of use, exposures, 

and populations of concern. This 

unreasonable risk can be addressed in a 

more coordinated, efficient, and 

effective manner under TSCA than 

under different laws implemented by 

different agencies. Moreover, the 

timeframe and any exposure reduction 

as a result of updating OSHA or CPSC 

regulations cannot be estimated, while 

TSCA requires a much more accelerated 

2-year statutory timeframe for proposing 

and finalizing regulatory requirements 

to address unreasonable risk. Further, 

there are key differences between the 

finding requirements of TSCA and those 

of the OSH Act, CPSA, and FHSA. For 

these reasons, in the Administrator’s 

discretion, the Administrator has 

analyzed this issue and does not 

determine that unreasonable risk from 

TCE may be prevented or reduced to a 

sufficient extent by an action taken 

under a Federal law not administered by 

EPA. However, EPA is requesting public 

comment on this issue (i.e., the 

sufficiency of an action taken under a 

Federal law not administered by EPA). 

B. TSCA Section 9(b) Analysis 

If EPA determines that actions under 

other Federal laws administered in 

whole or in part by EPA could eliminate 

or sufficiently reduce a risk to health or 

the environment, TSCA section 9(b) 

instructs EPA to use these other 

authorities to protect against that risk 

unless the Administrator determines in 

the Administrator’s discretion that it is 

in the public interest to protect against 

such risk under TSCA. In making such 

a public interest finding, TSCA section 

9(b)(2) states: ‘‘the Administrator shall 

consider, based on information 

reasonably available to the 

Administrator, all relevant aspects of 

the risk . . . and a comparison of the 

estimated costs and efficiencies of the 

action to be taken under this title and 

an action to be taken under such other 

law to protect against such risk.’’ 

Although several EPA statutes have 

been used to limit TCE exposure (Ref. 

9), regulations under those EPA statutes 

have limitations because they largely 

regulate releases to the environment, 

rather than occupational or consumer 

exposures. While these limits on 

releases to the environment are 

protective in the context of their 

respective statutory authorities, 

regulation under TSCA is also 

appropriate for occupational and 

consumer exposures and in some cases 

can provide upstream protections that 

would prevent the need for release 

restrictions required by other EPA 

statutes (e.g., Resource Conservation 

and Recovery Act (RCRA), CAA, Clean 

Water Act (CWA)). 

The primary exposures and 

unreasonable risk to consumers, 

bystanders, workers, and ONUs would 

be addressed by EPA’s proposed 

prohibitions and restrictions under 

TSCA section 6(a). In contrast, the 

timeframe and any exposure reduction 

as a result of updating regulations for 

TCE under the CAA, CWA, or RCRA 

cannot be estimated, nor would they 

address the direct human exposure to 

consumers, bystanders, workers, and 

ONUs from the conditions of use 

evaluated in the 2020 Risk Evaluation 

for TCE. More specifically, none of 

EPA’s other statutes (e.g., RCRA, CAA, 

CWA) can address exposures to workers 

and ONUs related to the specific 


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activities that result in occupational 

exposures, for example those associated 

with RCRA covered disposal 

requirements, such as in 40 CFR 261.24 

and 40 CFR 268.3. EPA therefore 

concludes that TSCA is the most 

appropriate regulatory authority able to 

prevent or reduce risks of TCE to a 

sufficient extent across the range of 

conditions of use, exposures, and 

populations of concern. 

For these reasons, the Administrator 

does not determine that unreasonable 

risk from TCE under the conditions of 

use evaluated in the 2020 TSCA Risk 

Evaluation for TCE, could be eliminated 

or reduced to a sufficient extent by 

actions taken under other Federal laws 

administered in whole or in part by 

EPA. 

C. TSCA Section 14 Requirements 

EPA is also providing notice to 

manufacturers, processors, and other 

interested parties about potential 

impacts to CBI that may occur if this 

rulemaking is finalized as proposed. 

Under TSCA section 14(b)(4), if EPA 

promulgates a rule pursuant to TSCA 

section 6(a) that establishes a ban or 

phase-out of a chemical substance, the 

protection from disclosure of any CBI 

regarding that chemical substance and 

submitted pursuant to TSCA will be 

‘‘presumed to no longer apply,’’ subject 

to the limitations identified in TSCA 

section 14(b)(4)(B)(i) through (iii). If this 

rulemaking is finalized as proposed, 

then pursuant to TSCA section 

14(b)(4)(B)(iii), the presumption against 

protection from disclosure would apply 

only to information about the specific 

conditions of use that this rulemaking 

would prohibit or phase out. 

Manufacturers or processors seeking to 

protect such information would be able 

to submit a request for nondisclosure as 

provided by TSCA sections 14(b)(4)(C) 

and 14(g)(1)(E). Any request for 

nondisclosure would need to be 

submitted within 30 days after receipt of 

notice from EPA under TSCA section 

14(g)(2)(A). EPA anticipates providing 

such notice via the Central Data 

Exchange or CDX. 

D. TSCA Section 26 Considerations 

In accordance with TSCA section 

26(h), EPA has used scientific 

information, technical procedures, 

measures, methods, protocols, 

methodologies, and models consistent 

with the best available science. As in 

the case of the unreasonable risk 

determination, risk management 

decisions for this proposed rule, as 

discussed in Unit III.B.3. and Unit V., 

were based on a risk evaluation, that 

was subject to public comment and 

independent, expert peer review, and 

was developed in a manner consistent 

with the best available science and 

based on the weight of the scientific 

evidence as required by TSCA sections 

26(h) and (i) and 40 CFR 702.43 and 

702.45. 

In particular, the ECEL values 

considered for the WCPP are derived 

from the analysis in the 2020 Risk 

Evaluation for TCE. The proposed ECEL 

value of 0.0011 ppm as an 8-hour TWA 

is based on developmental toxicity, the 

most sensitive acute and chronic noncancer health endpoint, specifically 

calculated based on the occupational 

acute, non-cancer human equivalent 

concentration (HEC) for fetal cardiac 

defects (Ref. 13). This is the 

concentration at which an adult human 

would be unlikely to experience the 

specified adverse effects if exposed for 

a working lifetime, including 

susceptible subpopulations. Similarly, 

the ECEL identified under the primary 

alternative regulatory option, based on a 

different health endpoint, 

immunotoxicity, is derived from the 

analysis in the 2020 Risk Evaluation for 

TCE. This ECEL is 0.0040 ppm as an 8- 

hour TWA which is based on the 

chronic non-cancer occupational HEC 

for autoimmunity (Ref. 14). As 

discussed in Unit VI.A., among the noncancer 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). Therefore, 

reducing exposures remaining above the 

ECEL of 0.0040 ppm would reduce the 

contribution to the unreasonable risk of 

injury to health driven by inhalation 

exposures in an occupational setting for 

those conditions of use identified as 

presenting unreasonable risk in the 2020 

Risk Evaluation for TCE under TSCA 

(Ref. 1, 14). 

The extent to which the various 

information, procedures, measures, 

methods, protocols, methodologies or 

models, as applicable, used in EPA’s 

decisions have been subject to 

independent verification or peer review 

is adequate to justify their use, 

collectively, in the record for this 

rulemaking. Additional information on 

the peer review and public comment 

process, such as the peer review plan, 

the peer review report, and the Agency’s 

response to comments, can be found in 

EPA’s risk evaluation docket (Docket ID 

No.: EPA–HQ–OPPT–2016–0737). 

IX. Requests for Comment 

EPA is requesting public comment on 

all aspects of this proposal, including 

the proposed and primary alternative 

regulatory actions and all individual 

elements of these, and all supporting 

analysis. Additionally, within this 

proposal, the Agency is soliciting 

feedback from the public on specific 

issues throughout this proposed rule. 

For ease of review, this unit summarizes 

those specific requests for comment. 

1. EPA is requesting public comment 

on all elements of the proposed 

regulatory action and the primary 

alternative regulatory action. 

2. EPA is requesting public comment 

regarding the need for exemptions from 

the rule (and under what specific 

circumstances), including exemptions 

from the proposed regulatory action and 

the primary alternative regulatory 

action, pursuant to the provisions of 

TSCA section 6(g). 

3. 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. 

4. EPA requests comment on whether 

EPA should promulgate definitions for 

each condition of use evaluated in the 

2020 Risk Evaluation for TCE, and, if so, 

whether the descriptions in Unit III.B.1. 

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. 

5. EPA requests comment on the 

proposed compliance dates for 

prohibitions of TCE manufacturing, 

processing, distribution in commerce, 

and use and whether additional time is 

needed, for example, for products to 

clear the channels of trade, or for 

implementing the use of substitutes; 

comments should include 

documentation such as the specific use 

of the chemical throughout the supply 

chain; concrete steps taken to identify, 

test, and qualify substitutes for those 

uses (including details on the 

substitutes tested and the specific 

certifications that would require 

updating); and estimates of the time 

required to identify, test, and qualify 

substitutes with supporting 

documentation. EPA also requests 

comment on whether these are the 

appropriate types of information for use 

in evaluating compliance requirements, 

and whether there are other 

considerations that should apply. 

6. 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 


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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.’’ 

7. EPA 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 

Units V.A.1.b. and c., and, if so, 

information on and rationale for any 

level that should be considered de 

minimis. 

8. EPA requests comment on whether 

additional recordkeeping requirements 

are warranted or additional time would 

be needed, for example, to begin the 

phaseout of processing TCE as an 

intermediate for the manufacture of 

HFC–134a. 

9. EPA is seeking comment on the 

actions that manufacturers who process 

TCE for the production of HFC–134a 

would take as a result of the proposed 

phaseout in Unit V.A.1.d, and whether 

this would motivate a decision to cease 

manufacture earlier than they would 

otherwise under the AIM Act phasedown. 

10. EPA requests comment on 

whether the 270-day proposed 

compliance date is practicable, whether 

additional time is needed, for example, 

for a regulated entity to implement a 

change to their disposal processes or to 

transition to alternative disposal 

methods and what those alternative 

disposal methods would be, and their 

cost and feasibility. 

11. EPA is requesting comment on 

how entities could demonstrate that 

they are reducing exposures to the 

extent possible (including 

considerations for technological 

feasibility) and is also requesting 

comment on whether EPA’s requirement 

should be that entities ensure that 

exposures are reduced below the ECEL, 

rather than to the extent possible or 

lowest achievable level. 

12. 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. 

13. EPA is requesting comment on the 

use of the ECEL value of 0.0040 ppm in 

the WCPP in the alternative regulatory 

action. 

14. 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, as 

further detailed in Unit IV.A. 

15. EPA is requesting comment on 

personal air sampling devices that are 

capable of detecting indoor air TCE 

concentrations at or below the proposed 

ECEL action level of 0.00055 ppm 

(0.0029 mg/m3) with the requisite 

precision and accuracy. 

16. EPA is requesting comment on 

using OSHA Method 1001, which has a 

personal breathing zone limit of 

detection for TCE of 18 ppb, or 0.018 

ppm, to set an interim exposure limit of 

0.036 ppm, with an action level of 0.018 

ppm, as described further in Unit 

V.A.2.b.i. 

17. EPA requests comments regarding 

replacing the proposed prohibitions 

with compliance with the WCPP, in the 

instance that regulated entities are able 

to consistently demonstrate compliance 

with an ECEL through effective controls. 

18. EPA requests comment on the 

potential to develop future technologies 

(e.g., engineering controls, 

administrative controls, PPE) involving 

TCE for the conditions of use listed in 

Unit V.A.1.a., Unit V.A.1.d., and Unit 

V.A.3 that would facilitate successful 

implementation of the WCPP, including 

an ECEL of 0.0011 ppm for TCE, dermal 

protection, and ancillary requirements 

described in Unit IV.A. 

19. EPA requests comment on the 

feasibility of controlling worker 

exposures to TCE at or below the 

proposed ECEL, and the accuracy of 

detections measurements at this level. 

20. EPA requests comment on 

whether a phased approach to an ECEL 

is desirable; that is, an approach that 

would establish a timeframe for meeting 

the ECEL as well as a shorter timeframe 

for meeting a concentration level higher 

than the ECEL (but lower than the PEL) 

that is currently considered achievable. 

EPA welcomes data or information to 

demonstrate that meeting the proposed 

ECEL over a sustained period of time 

would be feasible and measurable. 

21. EPA requests comments that 

provide supported recommendations for 

one or more incremental exposure 

values and associated timelines for 

achieving the incremental exposure 

levels and the currently proposed ECEL 

of 0.0011 ppm, and comments that 

consider and provide information on the 

needed advancements in exposure 

monitoring methods, analytical 

methods, and exposure controls, 

including expected timelines for 

developing these capabilities. 

22. EPA requests comment on how 

owners and operators should identify 

the lowest achievable exposure level, 

what documentation would be needed 

to support that further reductions are 

not possible, and whether EPA should 

provide a definition of meeting the 

ECEL to the extent possible. 

Additionally, EPA requests comment on 

whether current monitoring methods are 

able to detect airborne concentrations at 

the ECEL and action level values. EPA 

expects that detection and adherence to 

extremely low-ppm levels of TCE may 

present challenges to some in the 

regulated community; therefore, EPA is 

also requesting comment on whether 

EPA should propose specific 

requirements following results 

indicating non-detectable 

concentrations of TCE (non-detects), or 

a requirement that a specific monitoring 

method be used. 

23. EPA is soliciting comment 

regarding an ECEL action level that is 

half the ECEL and any associated 

provisions related to the ECEL action 

level when the ECEL is significantly 

lower than the OSHA PEL. EPA is also 

soliciting comment on whether the 

ECEL action level should be aligned 

with the OSHA PEL action level 

(typically set at half the limit), due to 

the fact that PEL accounts for 

technological feasibility and the action 

level is not necessarily designed to be 

health protective. Since exposure below 

the ECEL would be health protective, 

EPA seeks comment on whether the 

action level should be set at a different 

value closer to the ECEL that would 

trigger increased monitoring to ensure 

that the ECEL is not exceeded, and 

whether technological feasibility should 

be considered in setting the action 

level.. 

24. EPA requests comment on 

whether the action level should be set 

at a different value closer to the ECEL 

that would trigger increased monitoring 

to ensure that the ECEL is not exceeded, 

and whether technological feasibility 

should be considered in setting the 

action level. 

25. EPA is soliciting comments 

regarding the timing of the initial 

exposure monitoring so that it would be 

representative of all tasks involving TCE 

where exposures may approach the 

ECEL. EPA is also soliciting comments 

regarding use of area source monitoring 

instead of personal breathing zone as a 

representative sample of exposures. 

26. EPA requests comment on the 

timeframes for periodic monitoring 

outlined in Table 1 of Unit V.A.2. 

27. EPA is soliciting comment on 

requiring warning signs to demarcate 

regulated areas, such as the 

requirements found in OSHA’s General 

Industry Standard for Beryllium. 


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28. EPA is requesting comment on 

whether the owner or operator should 

be required to permit designated 

representatives of employees and other 

workers to enter regulated areas to 

observe exposure monitoring similar to 

typical OSHA Standard requirements, 

e.g., 29 CFR 1910.1024(d)(7). 

29. EPA is requesting comment on 

whether there should be a requirement 

to replace cartridges or canisters after a 

certain number of hours, such as the 

requirements found in OSHA’s General 

Industry Standard for 1,3-Butadiene, or 

a requirement for a minimum service 

life of non-powered air-purifying 

respirators such as the requirements 

found in OSHA’s General Industry 

Standard for Benzene. 

30. EPA is requesting comment on 

whether the timeframe to provide PPE 

to exposed workers should be shorter 

(e.g., within two weeks after the receipt 

of any exposure monitoring that 

indicates exposure exceeding the ECEL), 

given the severity of the effect, as 

discussed in Unit V.A.2. 

31. EPA requests comment on the 

degree to which additional guidance 

related to use of gloves might be 

necessary. Additionally, EPA requests 

comment on whether EPA should 

incorporate additional dermal 

protection requirements into the 

exposure control plan or require 

consideration of the hierarchy of 

controls for dermal exposures. 

32. EPA is requesting comment on 

how owners and operators can engage 

with potentially exposed persons on the 

development and implementation of an 

exposure control plan and PPE program. 

33. EPA requests comment relative to 

the ability of owners or operators to 

conduct initial monitoring within 6 

months after date of publication of the 

final rule in the Federal Register, and 

anticipated timeframes for any 

procedural adjustments (i.e., use of new 

technologies for personal breathing zone 

monitoring at extremely low-ppm levels 

of TCE) needed to comply with the 

requirements outlined in Unit V.A.2., 

including establishment of a respiratory 

protection program and development of 

an exposure plan. 

34. EPA is requesting comment 

regarding the amount of time, if any, it 

would take the regulated community to 

develop a method to measure at or 

below the ECEL over an entire work 

shift. EPA is interested in what levels of 

detection are possible based on existing 

monitoring methods, justification for the 

timeframe of the specific steps needed 

to develop a more sensitive monitoring 

method, and any additional detailed 

information related to establishing a 

monitoring program to reliably measure 

TCE at or below the ECEL. 

35. EPA also requests comment 

relative to the ability of owners or 

operators to implement dermal 

protection within 6 months of 

publication of the final rule in the 

Federal Register, and anticipated 

timeframes for any procedural 

adjustments needed to comply with the 

requirements outlined in Unit V.A.2. 

36. EPA requests comment on 

whether 10 years is an appropriate 

timeframe for the TSCA section 6(g) 

exemption for industrial and 

commercial use of TCE as a processing 

aid for battery separator manufacturing 

(lead-acid and lithium battery 

separators). 

37. EPA requests comment on 

whether 50 years is an appropriate 

timeframe for the TSCA section 6(g) 

exemption for the industrial and 

commercial use of TCE as a laboratory 

chemical (specifically in lab use 

essential for essential laboratory 

activities), Specifically, EPA requests 

comment on the anticipated duration of 

TCE cleanup projects, and whether 

there will be projects that continue and 

require the use of TCE as a laboratory 

chemical for the analysis of 

contaminated soil, air, and water 

samples past 50 years. 

38. EPA requests comment on the 

TSCA section 6(g) exemption for 

continued emergency use of TCE in the 

furtherance of NASA’s mission as 

described in Unit V.A.3.iii.a.vi, and 

whether any additional conditions of 

use should be included, in particular for 

any uses qualified for space flight for 

which no technically or economically 

feasible safer alternative is available. 

Additionally, EPA requests comment on 

what would constitute sufficient 

justification of an emergency. 

39. EPA requests comments on the 

appropriateness of identified 

compliance timeframes for 

recordkeeping and downstream 

notification requirements described in 

Unit V.A.2. 

40. EPA requests comment on the 

primary alternative regulatory action 

and whether any elements of this 

primary alternative regulatory action 

described in Unit IV.B. should be 

considered as EPA develops the final 

regulatory action. EPA also requests 

comment on the practicability of the 

timeframes under the primary 

alternative regulatory action outlined in 

Unit V.B. compared to the timeframes 

identified for the proposed regulatory 

action in Unit V.A. 

41. EPA requests comment on the 

practicability of the timeframes outlined 

for the phaseout of processing TCE as an 

intermediate for HFC–134a manufacture 

in Unit V.B. compared to the timeframes 

identified for the proposed regulatory 

action in Unit V.A., including 

consideration of the need for 

manufacturing (including import), and 

distribution in commerce to continue 

during the period of the phaseout. 

42. 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 for 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. 

43. EPA requests comment on 

whether the three-year alternative 

timeline would be practicable or 

whether additional time is needed, for 

example, for a regulated entity to 

implement a change to their wastewater 

collection, treatment, or disposal 

processes or infrastructure, and what 

those alternative disposal methods may 

be. 

44. EPA requests comment on the 

ability of regulated entities to conduct 

initial monitoring within 12 months, 

anticipated timeframes for any 

procedural adjustments needed to 

comply with the requirements, and the 

extent to which this option could result 

in additional exposure, compared to the 

proposed regulatory option as described 

in Unit V.A. 

45. EPA requests comment on the 

practicability of the timeframes outlined 

in this unit, when compared to the 

timeframes identified for the proposed 

regulatory action in Unit V.A. EPA 

requests comment on whether any 

elements of the primary alternative 

regulatory action described in this unit 

should be considered as EPA develops 

the final regulatory action, e.g., whether 

EPA should consider the timeframes for 

implementation of a WCPP presented in 

this primary alternative regulatory 

action and the ECEL value presented in 

the proposed regulatory action. 

46. EPA requests comment on the 

existing practices (e.g., engineering 

controls, administrative controls, PPE) 

involving TCE use in these conditions of 

use, as to whether activities may take 

place in closed systems and the degree 

to which users of TCE in these sectors 

could successfully implement an ECEL 

of 0.0011 ppm or an ECEL of 0.0040 

ppm as an 8-hour TWA, dermal 

protection, and ancillary requirements 

described in Units V.A.2. and V.B.2. 

47. EPA requests comment on the 

extent to which the use of TCE for vapor 


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degreasing of narrow tubing is a critical 

use for which no technically and 

economically feasible safer alternative is 

available. 

48. EPA therefore requests comment 

on the Agency’s consideration of an 

exemption from the prohibition on 

disposal of TCE by industrial pretreatment, industrial treatment, or 

publicly owned treatment works for 

cleanup projects undertaken under the 

authority of CERCLA, RCRA, or other 

federal, state, or local government 

environmental laws, regulations, or 

requirements. 

49. EPA requests comment on 

whether 50 years is a reasonable 

timeframe for a TSCA section 6(g)(1)(A) 

exemption for the cleanup of TCEcontaminated water and groundwater 

sites. Specifically, EPA requests 

comment on the anticipated duration of 

TCE cleanup projects, and whether 

there will be projects that may continue 

and require the disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works beyond 25 years. 

50. EPA requests comment on 

whether industry anticipates increased 

releases of TCE to outdoor air associated 

with the implementation of the WCPP. 

EPA requests comment on whether 

owners and operators should be 

required to attest in their exposure 

control plan that engineering controls 

selected do not increase emissions of 

TCE to ambient air outside of the 

workplace and document in their 

exposure control plan whether 

additional equipment was installed to 

capture emissions of TCE to ambient air. 

EPA requests comment on how such a 

requirement could impact the 

availability, feasibility, or cost of 

engineering controls as a means to 

reduce workplace exposures to or below 

the proposed ECEL. EPA is also 

soliciting comment on the frequency 

and nature of air monitoring EPA 

should consider including as 

requirements in the final rule. 

51. EPA requests comments on all 

aspects of the TSCA section 6(g) 

exemptions described in Units V.A.3. 

and V.B.3., including whether 

compliance with the WCPP should also 

be required during the period of the 

exemption. 

52. EPA is soliciting comment on if 

the exemption for laboratory use of TCE 

as described in Unit V.A.3.a.iii should 

include lab use of TCE for research and 

development purposes for objectives 

broader than cleanup activities or 

exposure monitoring, such as research 

into TCE alternatives, whether these 

broader objectives should be limited to 

federal agencies and their contractors or 

expanded to include others, and 

whether a shorter time period, such as 

10 years, should be imposed on these 

broader research and development 

activities. 

53. EPA is soliciting comment on 

whether it should specify the type of 

batch vapor degreasing operation, such 

as open-top or closed loop batch vapor 

degreasing, that would be exempt from 

prohibition as part of the primary 

alternative regulatory action for the 

industrial and commercial use of TCE in 

batch vapor degreasing for essential 

aerospace parts and narrow tubing used 

in medical devices and whether EPA 

should consider different exemption 

timeframes for different types of vapor 

degreasing operations. 

54. EPA requests comments on 

subsections of conditions of use, which 

by nature of their infrequent occurrence, 

could meet the ECEL without having 

their employees wear high APF levels of 

PPE on a daily basis. 

55. EPA requests public comment on 

the rationale for proposing prohibitions 

as the preferred risk management 

approach. In addition, EPA requests 

comment regarding the number of 

businesses and other entities that could 

potentially close as well as associated 

costs with a prohibition of TCE for the 

industrial and commercial conditions of 

use identified in Unit V.A.1. 

56. EPA requests comment on the 

effectiveness of a limited access 

program, such as a point-of-sale selfcertification or other administrative 

controls, to address the unreasonable 

risk of TCE, in particular for facilities 

with occupational exposures to TCE that 

may not be able to meet the WCPP 

requirements of this proposed 

rulemaking. 

57. EPA is soliciting comments on 

whether there are products in use or 

available for sale relevant to these 

conditions of use that contain TCE at 

this time, so that EPA can ascertain 

whether there are alternatives that 

benefit human health or the 

environment as compared to such use of 

TCE. 

58. EPA is requesting comment on the 

Alternatives Assessment as a whole. 

59. EPA is requesting public comment 

on an issue raised in its TSCA section 

9(a) Analysis described in Unit VIII.A., 

(i.e., the sufficiency of an action taken 

under a Federal law not administered by 

EPA). 

60. Following Panel report 

recommendations (Ref. 32) and in 

response to input provided by SERs, 

EPA is requesting comment on the 

following topics as outlined in the 

SBAR Panel Report: 

• EPA requests public comment on 

the extent to which a regulation under 

TSCA section 6(a) could minimize 

requirements, such as testing and 

monitoring protocols, recordkeeping, 

and reporting requirements, which may 

exceed those already required under 

OSHA’s regulations for TCE. 

• EPA requests public comment on 

reasonable compliance timeframes for 

small businesses, specifically on 

whether and how to provide longer 

compliance timeframes for transitioning 

to alternatives for uses requiring 

reformulation and cleaning processes 

for cleaning parts for national defense or 

cleaning medical devices. 

• EPA requests public comment on 

differing compliance or reporting 

requirements or timetables that account 

for the resources available to small 

entities. 

• EPA requests public comment on 

any additional appropriate factors for 

identifying reasonable compliance 

timeframes and how to weigh the factors 

for vapor degreasing and other 

industries. 

• EPA requests public comment the 

feasibility of entities complying with 

and monitoring for a potential ECEL of 

either 0.0011 ppm or 0.0040 ppm, 

specifically regarding potential costs 

that could be incurred using strategies 

to meet the requirements of such a 

standard, such as engineering, 

administrative, or prescriptive controls 

and how feasible it would be for entities 

to implement these strategies in their 

operations. 

• EPA requests public comment on 

the feasibility of use of alternatives to 

TCE and their availability for conditions 

of use that drive the unreasonable risk. 

• EPA requests public comment on a 

training and certification program for a 

commercial user to obtain a TCEcontaining product from a retailer, such 

as industrial supply stores or online 

retailers. 

• EPA requests public comment on a 

de minimis level in the case of an 

impurity or trace amounts of TCE in 

products. 

• EPA requests public comment on 

whether to allow the use of TCE by 

entities that could, based on 

demonstrated ability through 

monitoring data, meet the ECEL under 

a workplace chemical protection 

program. 

• EPA requests public comment on 

how the rulemaking should consider 

TCE alternatives in light of ongoing 

regulatory scrutiny. 

• EPA requests public comment on 

whether chemicals undergoing risk 

evaluation would be likely to be 


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considered as viable alternatives and, if 

so, in which circumstances. 

• EPA requests public comment on 

potential challenges associated with 

monitoring TCE below 0.0011 ppm and 

0.0040 ppm. 

• EPA requests public comment on 

whether the use of TCE in a closed-loop 

vapor degreasing system, when 

combined with requirements of a 

potential workplace chemical protection 

program, could meet the ECELs for TCE. 

X. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not itself physically located 

in the docket. For assistance in locating 

these other documents, please consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

1. EPA. Risk Evaluation for 

Trichloroethylene. EPA Document 

#740R18008. November 2020. 

2. EPA. Final Revised Unreasonable Risk 

Determination for Trichloroethylene, 

Section 5. December 2022. 

3. EPA. Economic Analysis of the Proposed 

Regulation of Trichloroethylene. 2023. 

4. EPA. Phasedown of Hydrofluorocarbons: 

Establishing the Allowance Allocation 

and Trading Program Under the 

American Innovation and Manufacturing 

Act; Final Rule. October 5, 2021. 

5. A. Tinker et al. Inpatient Hospitalization 

Costs Associated with Birth Defects 

Among Persons of All Ages—United 

States, 2013. MMWR. Morbidity and 

mortality weekly report vol. 66,2 41–46. 

January 20, 2017. 

6. M. Chen et al. Children with Heart 

Conditions and Their Special Health 

Care Needs—United States, 2016. 

MMWR. Morbidity and mortality weekly 

report vol. 67,38 1045–1049. 28. Sept. 

28, 2018. 

7. N. McClung et al. Financial burdens and 

mental health needs in families of 

children with congenital heart disease. 

Congenital heart disease 13.4 (2018): 

554–562. April 6, 2018. 

8. EPA. ChemView: Trichloroethylene (TCE), 

79–01–6. Last updated on June 2, 2023. 

https://chemview.epa.gov/chemview/ 

?tf=0&ch=79-01-6&su=

256737574985&as=31098&ac=

115166378999&ma=4-11-1981377-4_

16848473-4_16848474-4_

49007566&gs=&tds=0&

tdl=10&tas1=1&tas2=asc&tas3=

undefined&tss=&modal=

detail&modalId=100616&modalSrc=2-5- 

10-1-6378999-4-11-1981377. 

9. EPA. Summary of EPA Regulations 

Pertaining to Trichloroethylene (TCE); 

and Other Federal, State, and 

International Regulations. September 

2023. 

10. OSHA. Standard Interpretations: 8-hr 

total weight average (TWA) permissible 

exposure limit (PEL). December 18, 2003. 

https://www.osha.gov/laws-regs/ 

standardinterpretations/2003-12-18-1. 

11. EPA. Trichloroethylene (TCE); Revision 

to the Toxic Substances Control Act 

(TSCA) Risk Determination; Notice of 

Availability. Federal Register (88 FR 

1222, January 9, 2023) (FRL–9945–02– 

OCSPP). 

12. NIOSH. Hierarchy of Controls. Last 

Reviewed January 17, 2023. https://

www.cdc.gov/niosh/topics/hierarchy/. 

13. EPA. Second Existing Chemical Exposure 

Limit (ECEL) (Developmental Toxicity) 

for Occupational Use of 

Trichloroethylene. March 31, 2022. 

14. EPA. Existing Chemical Exposure Limit 

(ECEL) for Occupational Use of 

Trichloroethylene. February 22, 2021. 

15. AFL–CIO v. OSHA, 965 F.2d 962 (11th 

Cir. 1992). 

16. ACGIH. ACGIH TLVs. n.d. https://

www.acgih.org/trichloroethylene/. 

17. NIOSH. NIOSH Pocket Guide to Chemical 

Hazards—Trichloroethylene. Last 

Reviewed October 30, 2019. https://

www.cdc.gov/niosh/npg/npgd0629.html. 

18. NIOSH. Appendix A—NIOSH Potential 

Occupational Carcinogens. Last 

Reviewed October 17, 2018. https://

www.cdc.gov/niosh/npg/ 

nengapdxa.html. 

19. State of California Department of 

Industrial Relations. Table AC–1 

Permissible Exposure Limits For 

Chemical Contaminants. n.d. https://

www.dir.ca.gov/title8/5155table_

ac1.html. 

20. NIOSH. Recommendations for 

Occupational Safety and Health. January 

1992. 

21. Executive Order 13985. Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government. Federal Register (86 FR 

7009, January 20, 2021). 

22. Executive Order 13990. Protecting Public 

Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis. Federal Register (86 FR 7037, 

January 25, 2021). 

23. Executive Order 14008. Tackling the 

Climate Crisis at Home and Abroad. 

Federal Register (86 FR 7619, February 

1, 2021). 

24. EPA. EPA Announces Path Forward for 

TSCA Chemical Risk Evaluations. June 

30, 2021. https://www.epa.gov/ 

newsreleases/epa-announces-pathforward-tsca-chemical-risk-evaluations. 

25. EPA. TSCA Science Advisory Committee 

on Chemicals Meeting Minutes and Final 

Report. March 24–27, 2020. 

26. EPA. Notes from Federalism Consultation 

on Forthcoming Proposed Rulemakings 

for Trichloroethylene, 

Perchloroethylene, and nmethylpyrrolidone under TSCA Section 

6(a). July 22, 2021. 

27. EPA. Notes from Tribal Consultations on 

Forthcoming Proposed Rulemakings for 

Trichloroethylene (TCE) and 

Perchloroethylene (PCE). June 15 and 

July 8, 2021. 

28. W. Heiger-Bernays and G. Nielsen. 

Environmental Justice Consultation 

Comment 1 for TCE and PCE. July 5, 

2021. 

29. S. Rayasam. Environmental Justice 

Consultation Comment 2 for TCE and 

PCE. June 16, 2021. 

30. S. Liu. Environmental Justice 

Consultation Comment 3 for TCE and 

PCE. August 20, 2021. 

31. EPA. Notes from Environmental Justice 

Consultations on Forthcoming Proposed 

Rulemakings for Trichloroethylene (TCE) 

and Perchloroethylene (PCE). July 2021. 

32. Small Business Advocacy Review Panel. 

Final Report of the Small Business 

Advocacy Review Panel on EPA’s 

Planned Proposed Rule for 

Trichloroethylene (TCE). April 4, 2023. 

33. EPA. Initial Regulatory Flexibility 

Analysis (IRFA) for Proposed Regulation 

of Trichloroethylene. 

34. EPA. Public Webinar on 

Trichloroethylene (TCE): Risk Evaluation 

and Risk Management under TSCA 

Section 6. December 15, 2020. 

35. EPA. Stakeholder Meeting List for 

Proposed Rulemaking for 

Trichloroethylene under TSCA Section 

6(a). May 19, 2023. 

36. EPA. 2021 Policy on Children’s Health. 

October 5, 2021. 

37. EPA. Problem Formulation of the Risk 

Evaluation for Trichloroethylene. May 

2018. 

38. EPA. Scope of the Risk Evaluation for 

Trichloroethylene. June 2017. 

39. EPA. Final Scope of the Risk Evaluation 

for 1,2-Dichloroethane. August 2020. 

40. EPA. Asbestos Part 1: Chrysotile 

Asbestos; Regulation of Certain 

Conditions of Use Under Section 6(a) of 

the Toxic Substances Control Act 

(TSCA). April 12, 2022. 

41. EPA. Guidelines for Carcinogen Risk 

Assessment. March 2005. 

42. EPA. Trichloroethylene (TCE); Revision 

to Toxic Substances Control Act (TSCA) 

Risk Determination; Respone to Public 

Comments. December 2022. 

43. NASA. Solid Rocket Motor Nozzles 

Mission Critical Requirement for 

Trichloroethylene. February 1, 2023. 

44. OSHA. Occupational Exposure to 

Methylene Chloride. January 10, 1997. 

45. EPA. Passive Samplers for Investigations 

of Air Quality: Method Description, 

Implementation, and Comparison to 

Alternative Sampling Methods. 

December 2014. 

46. EPA. Second Existing Chemical Exposure 

Limit (ECEL) (Developmental Toxicity) 

for Occupational Use of 

Trichloroethylene; Appendix B. March 

31, 2022. 

47. OSHA. Personal Protective Equipment. 

2023. 

48. ENTEK. ENTEK International LLC, 

Request for Section 6(g) Exemption. July 

14, 2021. 

49. Microporous. Microporous LLC 

(‘‘Microporous’’), Request for Section 

6(g) Exemption. August 10, 2022. 

50. Battery Council International. Letter in 

Support of ENTEK Request for Section 

6(g) Exemption for Battery Separator 

Manufacturing. September 3, 2021. 


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51. The Federal Consortium for Advanced 

Batteries. Executive Summary National 

Blueprint For Lithium Batteries 2021– 

2030. June 2021. 

52. ENTEK. Analysis of Alternatives for the 

use of trichloroethylene as an extraction 

solvent for removal of process oil and 

formation of the porous structure in 

polyethylene based separators used in 

lead-acid batteries. August 2021. 

53. EPA. Assistant Administrator Meeting 

with ENTEK on a TSCA Section 6(g) 

Exemption Request in Risk Management 

for Trichloroethylene (TCE). February 

15, 2022. 

54. ENTEK. Attachment B to July 14, 2021 

Letter From ENTEK EPA. 

55. European Chemical Agency. Adopted 

opinions and previous consultations on 

applications for authorisation. n.d. 

https://echa.europa.eu/applications-forauthorisation-previous-consultations/-/ 

substance-rev/6385/term; https://

echa.europa.eu/applications-forauthorisation-previous-consultations/-/ 

substance-rev/6384/term. 

56. NASA. Known Uses of Trichloroethylene. 

December 14, 2022. 

57. K. Black. The Nuclear Asphalt Content 

Gauge. 1995. https://highways.dot.gov/ 

public-roads/winter-1995/nuclearasphalt-content-gauge. 

58. U.S. Department of State. A Strategic 

Framework for Space Diplomacy. May 

25, 2023. 

59. M. Finckenor. Materials for Spacecraft. 

NASA. 2016. 

60. The Boeing Company. Comments 

Supporting Request for Additional 

Information on Trichloroethylene (TCE); 

Rulemaking Under TSCA Section 6(a). 

May 6, 2022. 

61. The Boeing Company. Comments 

Concerning Trichloroethylene (TCE); 

Regulation of Use in Vapor Degreasing 

Under TSCA Section 6(a). May 19, 2017. 

62. The Boeing Company. Information on 

FAA Certification. December 9, 2022. 

63. 3M. 3M to Exit PFAS Manufacturing by 

the End of 2025. December 20, 2022. 

https://news.3m.com/2022-12-20-3M-toExit-PFAS-Manufacturing-by-the-End-of2025. 

64. Viant. Viant Comments on the November 

2020 TCE Risk Evaluation. November 17, 

2021. 

65. EPA. Meeting Summary—EPA Visit at the 

Integer facility in Minneapolis, MN. 

October 19, 2017. 

66. EPA. National Air Emission Standards for 

Hazardous Air Pollutants: Halogenated 

Solvent Cleaning. May 3, 2007. 

67. PPG. PPG TSCA Section 6(g) Exemption 

Request. June 29, 2023. 

68. EPA. Trichloroethylene (TCE); Regulation 

of Use in Vapor Degreasing Under TSCA 

Section 6(a). Federal Register. (82 FR 

7432, January 19, 2017)(FRL–9950–08). 

69. NIOSH. NIOSH Guide to the Selection 

and Use of Particulate Respirators. 

January 1996. https://www.cdc.gov/ 

niosh/docs/96-101/default.html. 

70. Arkema. Arkema Inc. Comments on Draft 

Toxic Substances Control Act (TSCA) 

Risk Evaluation and TSCA Science 

Advisory Committee on Chemicals 

(SACC) Meetings. April 27, 2020. 

71. EPA. Alternatives Assessment for 

Proposed Regulation of 

Trichloroethylene. 

72. EPA. Meeting with Safechem on Risk 

Management under TSCA Section 6(a) 

for Trichloroethylene. March 23, 2023. 

73. Koura. Production of R–134a. 2017. 

74. National Cleaners Association. National 

Cleaners Association Comments on the 

Phaseout of Trichloroethylene (TCE). 

February 13, 2023. 

75. Axiall. Safety Data Sheet for 

Trichlorethylene. October 26, 2013. 

76. EPA. EPA Response to Letter of Concern 

from Louisiana Department of 

Environmental Quality’s (LDEQ) and the 

Louisiana Department of Health (LDH). 

October 12, 2022. 

77. EPA. Memorandum Trichloroethylene 

(TCE): Fenceline Technical Support— 

Ambient Air Pathway. March 3, 2022. 

78. EPA. Draft TSCA Screening Level 

Approach for Assessing Ambient Air and 

Water Exposures to Fenceline 

Communities. January 2022. 

79. EPA. Memorandum Trichloroethylene: 

Fenceline Technical Support—Water 

Pathway. March 24, 2023. 

80. OMB. Memorandum for Guidance for 

Implementing Title II of the Unfunded 

Mandates Reform Act (UMRA). March 

31, 1995. 

81. CPSC. Statutes. n.d. https://

www.cpsc.gov/Regulations-Laws-- 

Standards/Statutes. 

82. EPA. Supporting Statement for an 

Information Collection Request (ICR) 

Under the Paperwork Reduction Act 

(PRA); Regulation of Trichloroethylene 

under TSCA Section 6(a); Proposed Rule 

(RIN 2070–AK83). EPA ICR No. 2775.01. 

September 2023. 

XI. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Orders 12866: Regulatory 

Planning and Review and 14094: 

Modernizing Regulatory Review 

This action is a ‘‘significant regulatory 

action’’ as defined in Executive Order 

12866 (58 FR 51735, October 4, 1993), 

as amended by Executive Order 14094 

(88 FR 21879, April 11, 2023). 

Accordingly, EPA submitted this action 

to OMB for Executive Order 12866 

review. Documentation of any changes 

made in response to the Executive Order 

12866 review is available in the docket. 

EPA prepared an economic analysis 

(Ref. 3) of the potential costs and 

benefits associated with this action, 

which is available in the docket and is 

summarized in Unit VI.D. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this proposed rule have been 

submitted to OMB under the PRA, 44 

U.S.C. 3501 et seq. The Information 

Collection Request (ICR) document that 

EPA prepared has been assigned EPA 

ICR No. 2775.01 (Ref. 82). You can find 

a copy of the ICR in the docket for this 

rulemaking, and it is briefly 

summarized here. 

There are two primary provisions of 

the proposed rule that may increase 

burden under the PRA. The first is 

downstream notification, which would 

be carried out by updates to the relevant 

SDS and which would be required for 

manufacturers, processors, and 

distributors in commerce of TCE, who 

would provide notice to companies 

downstream upon shipment of TCE 

about the prohibitions. The information 

submitted to downstream companies 

through the SDS would provide 

knowledge and awareness of the 

restrictions to these companies. The 

second primary provision of the 

proposed rule that may increase burden 

under the PRA is WCPP-related 

information generation, recordkeeping, 

and notification requirements 

(including development of exposure 

control plans; exposure level monitoring 

and related recordkeeping; development 

of documentation for a PPE program and 

related recordkeeping; development of 

documentation for a respiratory 

protection program and related 

recordkeeping; development and 

notification to potentially exposed 

persons (employees and others in the 

workplace) about how they can access 

the exposure control plans, exposure 

monitoring records, PPE program 

implementation documentation, and 

respirator program documentation; and 

development of documentation 

demonstrating eligibility for an 

exemption from the proposed 

prohibitions, and related 

recordkeeping). 

Respondents/affected entities: 

Persons that manufacture (including 

import), process, distribute in 

commerce, use, or dispose of TCE or 

products containing TCE. See also Unit 

I.A. 

Respondent’s obligation to respond: 

Mandatory (TSCA section 6(a) and 40 

CFR part 751). 

Estimated number of respondents: 

22,113. 

Frequency of response: On occasion. 

Total estimated burden: 12,197 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $1,702,625 (per 

year), includes $722,586 annualized 

capital or operation and maintenance 

costs. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 


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unless it displays a currently valid OMB 

control number. The OMB control 

numbers for certain EPA regulations in 

40 CFR are listed in 40 CFR part 9 and 

displayed on the form and instructions 

or collection portal, as applicable. 

Submit your comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates, and any suggested methods 

for minimizing respondent burden to 

the EPA using the docket identified at 

the beginning of this proposed rule. EPA 

will respond to ICR-related comments in 

the final rule. You may also send your 

ICR-related comments to OMB’s Office 

of Information and Regulatory Affairs 

using the interface at https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular ICR by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. OMB must receive 

comments no later than November 30, 

2023. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to section 603 of the RFA, 5 

U.S.C. 601 et seq., EPA prepared an 

initial regulatory flexibility analysis 

(IRFA) (Ref. 33) that examines the 

impact of the proposed rule on small 

entities along with regulatory 

alternatives that could minimize that 

impact. The complete IRFA is available 

for review in the docket and is 

summarized here. 

1. Need for the Rule 

Under TSCA section 6(a) (15 U.S.C. 

2605(a)), if EPA determines after a 

TSCA section 6(b) risk evaluation that a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, without consideration 

of costs or other nonrisk factors, 

including an unreasonable risk to a 

PESS identified as relevant to the risk 

evaluation, under the conditions of use, 

EPA must by rule apply one or more 

requirements listed in TSCA section 6(a) 

to the extent necessary so that the 

chemical substance or mixture no longer 

presents such risk. TCE was the subject 

of a risk evaluation under TSCA section 

6(b)(4)(A) that was issued in November 

2020. In addition, in January 2023, EPA 

issued a revised unreasonable risk 

determination 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. 

2. Objectives and Legal Basis 

Under TSCA section 6(a) (15 U.S.C. 

2605(a)), if EPA determines through a 

TSCA section 6(b) risk evaluation that a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, EPA must by rule 

apply one or more requirements listed 

in TSCA section 6(a) to the extent 

necessary so that the chemical 

substance or mixture no longer presents 

such risk. EPA has determined through 

a TSCA section 6(b) risk evaluation that 

TCE presents an unreasonable risk 

under the conditions of use. 

3. Description and Number of Small 

Entities to Which the Rule Will Apply 

The proposed rule potentially affects 

small manufacturers (including 

importers), processors, distributors, 

retailers, users of TCE or of products 

containing TCE, and entities engaging in 

disposal. EPA estimates that the 

proposal would affect approximately 

22,113 overall firms, of which 21,571 

small entities have estimated impacts. 

End users with economic and 

technologically feasible alternatives are 

estimated to only incur costs associated 

with rule familiarization. 

4. Projected Compliance Requirements 

To address the unreasonable risk EPA 

has identified, EPA is proposing to: 

Prohibit the manufacture (including 

import), processing, and distribution in 

commerce of TCE for all uses (including 

all consumer uses), with longer 

timeframes for manufacture and 

processing related to certain uses; 

prohibit the industrial and commercial 

use and distribution in commerce of 

TCE, with longer timeframes for certain 

uses; prohibit the manufacture 

(including import) and processing of 

TCE as an intermediate for the 

manufacture of HFC 134-a, following an 

8.5-year phaseout; 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; prohibit the manufacturing 

(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; 

prohibit the manufacturing (including 

import), processing, distribution in 

commerce, and use of TCE as a 

laboratory chemical (specifically in lab 

use essential for essential laboratory 

activities) following a 50-year TSCA 

section 6(g) exemption; Require strict 

workplace controls, including a TCE 

workplace chemical protection program 

(WCPP), which would include 

requirements for an inhalation exposure 

limit and glove requirements to limit 

dermal exposure to TCE, for conditions 

of use with long term phaseouts or timelimited exemptions under TSCA section 

6(g); prohibit disposal to industrial pretreatment, industrial treatment, or 

publicly owned treatment works 

following a 50-year TSCA section 6(g) 

exemption for cleanup projects; and 

establish recordkeeping and 

downstream notification requirements. 

EPA is proposing to prohibit all 

conditions of use. EPA is proposing 

longer timeframes (with workplace 

controls) for prohibitions on certain 

conditions of use. For the reasons 

described in Unit V., EPA notes that 

long-term implementation of the WCPP 

is not a feasible means of addressing 

unreasonable risk and that prohibition 

of the COUs is ultimately necessary to 

address the unreasonable risk. 

Furthermore, when selecting among 

proposed prohibitions and other 

restrictions that would apply to those 

occupational conditions of use, EPA has 

also factored in considerations relating 

to health effects on PESS, including 

older pregnant women (the group 

identified as most susceptible to fetal 

cardiac defects), further discussed in 

Unit VI.A. EPA is proposing a WCPP for 

several conditions of use of TCE in 

order to address to the extent possible 

the unreasonable risk during the time 

period before a prohibition becomes 

effective. The WCPP would include the 

ECEL, the associated implementation 

requirements, and may include other 

components, such as dermal protection. 

As described in Unit V.A., the TCE 

WCPP would be non-prescriptive, in the 

sense that regulated entities would not 

be required to use specific controls 

prescribed by EPA to achieve the 

exposure concentration limit. Rather, it 

would be a performance-based exposure 

limit that would enable owners or 

operators to determine how to most 

effectively meet the exposure limit 

based on conditions at their workplace. 

A central component of the TCE 

WCPP is the exposure limit. Exposures 

remaining at or below the ECEL would 

address any unreasonable risk of injury 

to health driven by inhalation exposures 

for occupational conditions of use in the 

TSCA 2020 Risk Evaluation. For TCE, 

EPA is proposing an ECEL of 0.0011 

parts per million (ppm) (0.0059 mg/m3) 

for inhalation exposures to TCE as an 8- 

hour TWA. As discussed in Unit 

V.A.2.b.i., EPA acknowledges the 

challenges of complying with the WCPP 

due to suitable personal breathing zone 

monitoring methods to detect TCE air 

concentration levels at the ECEL, and 

requests comment on using OSHA 


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Method 1001 to set an interim exposure 

limit. 

Where elimination, substitution, 

engineering controls, and administrative 

controls are not feasible to reduce the 

air concentration to or below the ECEL 

for all potentially exposed persons, EPA 

is proposing to require implementation 

of a PPE program in alignment with 

OSHA’s General Requirements for 

Personal Protective Equipment at 29 

CFR 1910.132. Consistent with 29 CFR 

1910.132, owners and operators would 

be required to provide PPE, including 

respiratory protection and dermal 

protection selected in accordance with 

the guidelines described in this unit, 

that is of safe design and construction 

for the work to be performed. EPA is 

proposing to require owners and 

operators ensure each potentially 

exposed person who is required by this 

unit to wear PPE to use and maintain 

PPE in a sanitary, reliable, and 

undamaged condition. Owners and 

operators would be required to select 

and provide PPE that properly fits each 

potentially exposed person who is 

required by this unit to use PPE and 

communicate PPE selections to each 

affected person. 

As described further in Unit VI., EPA 

believes that long-term implementation 

of the WCPP for continued use of TCE 

is not a feasible means of addressing 

unreasonable risk such that prohibition 

may ultimately be necessary to address 

the unreasonable risk. 

EPA is not proposing reporting 

requirements beyond downstream 

notification (third-party notifications). 

Regarding recordkeeping requirements, 

three primary provisions of the 

proposed rule relate to recordkeeping. 

The first is recordkeeping of general 

records: all persons who manufacture, 

process, distribute in commerce, or 

engage in industrial or commercial use 

of TCE or TCE-containing products must 

maintain ordinary business records, 

such as invoices and bills-of-lading 

related to compliance with the 

prohibitions, restrictions, and other 

provisions of the regulation. 

The second is recordkeeping related 

to WCPP compliance: under the 

proposed regulatory action, facilities 

complying with the rule through the 

WCPP would be required to develop 

and maintain records associated with 

ECEL exposure monitoring (including 

measurements, compliance with Good 

Laboratory Practice Standards, and 

information regarding monitoring 

equipment); compliance with the ECEL 

or lowest achievable exposure level 

(including the exposure control plan, 

PPE program implementation, and 

workplace information and training); 

PPE compliance (including the exposure 

control plan, PPE program 

implementation, basis for specific PPE 

selection, and workplace information 

and training); and workplace 

participation. This would also include 

recordkeeping related to the exemptions 

proposed under TSCA section 6(g), 

which would provide longer 

compliance dates for entities engaged in 

specific activities with TCE for which 

prohibition in the short term would be 

disruptive to national security or critical 

infrastructure. To maintain eligibility 

for the time-limited exemptions, EPA is 

proposing that owners and operators 

maintain records demonstrating 

compliance with the specific conditions 

of the exemption, including compliance 

with the WCPP by meeting the ECEL to 

the extent possible. To support and 

demonstrate compliance, EPA is 

proposing that each owner or operator 

of a workplace subject to the WCPP 

retain compliance records for five years. 

The third is recordkeeping related to 

the phaseouts for processing TCE in 

manufacture of HFC–134a (for which 

each manufacturer of HFC–134a who 

uses TCE as an intermediate would be 

required to maintain production volume 

records demonstrating compliance with 

setting the baseline and the phaseout) or 

use as a solvent for closed-loop batch 

vapor degreasing for rayon fabric 

scouring (for which each person using 

TCE would be required to maintain 

records demonstrating that the end use 

is for rocket booster nozzle production 

for Federal agencies and their 

contractors and would, within five 

years, be required to maintain records 

that demonstrate that a final pre-launch 

test of rocket booster nozzles was 

completed without using TCE in the 

production of rocket booster nozzles for 

Federal agencies and their contractors). 

a. Classes of Small Entities Subject to 

the Compliance Requirements 

The small entities that would be 

potentially directly regulated by this 

rulemaking are small entities that 

manufacture (including import), 

process, distribute in commerce, use, or 

dispose of TCE, including retailers of 

TCE for end-consumer uses. 

b. Professional Skills Needed To 

Comply 

Entities that would be subject to this 

proposal that manufacture (including 

import), process, or distribute TCE in 

commerce would be required to cease 

under the proposed rule. The entity 

would be required to modify their SDS 

or develop another way to inform their 

customers of the prohibition on 

manufacture, processing, and 

distribution of TCE. They would also be 

required to maintain ordinary business 

records, such as invoices and bills-oflading, that demonstrate compliance 

with the prohibitions, restrictions, and 

other provisions of this proposed 

regulation. These are all routine 

business tasks that do not require 

specialized skills or training. 

Entities that use TCE in any industrial 

and commercial capacity would be 

required to cease under the proposed 

rule, with some timeframes for 

prohibitions longer than others. 

Restriction or prohibition of these uses 

would likely require the 

implementation of an alternative 

chemical or the cessation of use of TCE 

in a process or equipment that may 

require persons with specialized skills, 

such as engineers or other technical 

experts. Instead of developing an 

alternative method themselves, 

commercial users of TCE may choose to 

contract with another entity to do so. 

Entities that would be permitted to 

continue on a time-limited basis until 

prohibition to manufacture, process, 

distribute, or use TCE would be 

required to implement a WCPP and 

would have to attempt to meet the 

provisions of the program to the extent 

possible for continued use of TCE. A 

transition to a WCPP may require 

persons with specialized skills such as 

an engineer or health and safety 

professional. Instead of implementing 

the WCPP to the extent possible, entities 

that use TCE may choose to contract 

with another entity to do so. Records 

would have to be maintained for 

compliance with a WCPP by meeting 

the ECEL to the extent possible. While 

this recording activity itself may not 

require a special skill, the information 

to be measured and recorded may 

require persons with specialized skills 

such as an industrial hygienist. 

5. Relevant Federal Rules 

Because of its health effects, TCE is 

subject to numerous State, Federal, and 

international regulations restricting and 

regulating its use. The following is a 

summary of the regulatory actions 

pertaining to TCE; for a full description 

see appendix A of the 2020 Risk 

Evaluation for TCE and the summary in 

the docket (Ref. 9). 

EPA has published numerous rules 

and Federal Register documents 

pertaining to TCE under its various 

authorities. 

Under a Significant New Use Rule 

(SNUR), (81 FR 20535, April 8, 2016), 

issued under the authority of TSCA 

section 5(a), TCE is subject to 

notifications for manufacture (including 

import) or processing of TCE for use in 


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a consumer product except for use in 

cleaners and solvent degreasers, film 

cleaners, hoof polishes, lubricants, 

mirror edge sealants and pepper spray. 

This SNUR ensures that EPA will have 

the opportunity to review any new 

consumer uses of TCE and, if 

appropriate, take action to prohibit or 

limit those uses. 

The TSCA section 8(a) Chemical Data 

Reporting (CDR) Rule requires 

manufacturers (including importers) to 

give EPA basic exposure-related 

information on the types, quantities and 

uses of chemical substances produced 

domestically and imported into the 

United States. TCE manufacturing 

(including importing), processing, and 

use information is reported under the 

CDR rule (76 FR 50816, August 16, 

2011). 

TCE is a hazardous air pollutant 

under the CAA (42 U.S.C. 7412(b)(1)). 

Under section 112(d), EPA has 

established national emission standards 

for hazardous air pollutants (NESHAPs) 

for a number of source-specific 

categories that emit TCE, including 

synthetic organic chemical 

manufacturing (40 CFR part 63, subparts 

F, G, and H), miscellaneous organic 

chemical manufacturing (40 CFR part 

63, subpart FFFF), and aerospace 

manufacturing and rework facilities (40 

CFR part 63, subpart GG). Under 

sections 112(d) and 112(f), EPA has 

promulgated a number of risk and 

technology review (RTR) NESHAPs, 

including the RTR NESHAP for 

Halogenated Solvent Cleaning (40 CFR 

part 63, subpart T). With this proposed 

rule under TSCA section 6, uses and 

emissions already regulated under these 

NESHAPs would be prohibited, with 

some of these uses identified for a 

longer phaseout timeframe under TSCA 

section 6. 

Under the CAA section 612, EPA’s 

Significant New Alternatives Policy 

(SNAP) program listed TCE as an 

acceptable substitute for methyl 

chloroform and chlorofluorocarbon 

(CFC)-113 in metals, electronics, and 

precision cleaning; as an alternative to 

CFC–11, CFC–113, methyl chloroform, 

and hydrochlorofluorocarbon (HCFC)- 

141b for aerosol solvent use; and as an 

alternative for methyl chloroform for 

use as a carrier solvent in adhesives, 

coatings, and inks (59 FR 13044, March 

18, 1994). TCE was also noted to have 

essentially no ozone depletion potential 

and cited as a volatile organic 

compound (VOC)-exempt solvent and 

acceptable substitute for ozonedepleting substances (72 FR 30142, May 

30, 2007). TCE is also listed under the 

National Volatile Organic Compound 

Emission Standards for Aerosol 

Coatings (40 CFR part 59, subpart E). 

Under the American Innovation and 

Manufacturing Act (AIM Act) that 

directs EPA to phase down the 

production and consumption of HFCs, 

EPA set HFC production and 

consumption baseline levels from which 

reductions will be made (86 FR 55116, 

October 5, 2021). The rule also 

establishes an initial methodology for 

allocating and trading HFC allowances 

for 2022 and 2023. TCE is identified as 

a feedstock chemical for HFC 

production, specifically HFC–134a. 

TCE is designated as a toxic pollutant 

under section 307(a)(1) of the Clean 

Water Act and as such is subject to 

effluent limitations. Also under section 

304, TCE is included in the list of total 

toxic organics (TTO) (40 CFR 413.02(i)). 

In 2015, EPA published updated 

ambient water quality criteria for TCE, 

including recommendations for ‘‘water 

+ organism’’ and ‘‘organism only’’ 

human health criteria for States and 

authorized tribes to consider when 

adopting criteria into their water quality 

standards (80 FR 36986, June 29, 2015). 

TCE is also subject to National Primary 

Drinking Water Regulations (NPDWR) 

under the Safe Drinking Water Act 

(SDWA) with a maximum contaminant 

level goal (MCGL) of zero and an 

enforceable maximum contaminant 

level (MCL) of 0.005 mg/L (40 CFR 

141.50; 40 CFR 141.61). 

Programs within EPA implementing 

other environmental statutes, including, 

but not limited to, the RCRA, the 

Comprehensive Environmental 

Response, Compensation and Liability 

Act, the Safe Drinking Water Act, and 

the CWA, classify TCE as a 

characteristic and listed hazardous 

waste (40 CFR 261.24, 40 CFR 261.31, 

40 CFR 261.33(f)). In 2013, EPA 

modified its hazardous waste 

management regulations to 

conditionally exclude solventcontaminated wipes that have been 

cleaned and reused from the definition 

of solid waste under RCRA and to 

conditionally exclude solventcontaminated wipes that are disposed 

from the definition of hazardous waste 

(78 FR 46448, July 31, 2013). However, 

TCE-contaminated wipes were not 

eligible for this exclusion due to health 

and safety concerns. 

EPA notes that TCE was first 

registered as an antimicrobial and 

conventional chemical in 1985 pursuant 

to the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA). TCE is 

not currently used in pesticides, either 

as an active or inert ingredient. While 

TCE was previously used as an inert, 

EPA removed TCE from its list of inert 

ingredients used in pesticide products 

in 1998 (63 FR 34384, June 24, 1998). 

While TSCA shares equity in the 

regulation of TCE, EPA does not 

anticipate this rulemaking to duplicate 

nor conflict with the aforementioned 

programs’ classifications and associated 

rules. 

In addition to EPA actions, TCE is 

also subject to other Federal regulations. 

Under the OSH Act, OSHA established 

the PEL for TCE at 100 ppm as an 8- 

hour TWA with an acceptable ceiling 

concentration of 200 ppm and an 

acceptable maximum peak above the 

acceptable ceiling concentration for an 

8-hour shift of 300 ppm, maximum 

duration of 5 minutes in any 2 hours (29 

CFR 1910.1000). However, EPA 

recognizes that the existing PEL does 

not eliminate the unreasonable risk 

identified by EPA under TSCA, and 

EPA is therefore proposing prohibitions 

based on the unreasonable risk 

identified following the TSCA 2020 Risk 

Evaluation for TCE, with time-limited 

requirements to meet to the extent 

possible a new, lower exposure limit. 

The implementation of those 

requirements would align with existing 

OSHA requirements where possible. For 

TCE, this approach would eliminate the 

unreasonable risk driven by certain 

conditions of use, reduce burden for 

complying with the regulations, and 

provide the familiarity of a pre-existing 

framework for the regulated community. 

Under the FFDCA, the Food and Drug 

Administration established tolerances 

for residues of TCE resulting from its 

use as a solvent in the manufacture of 

decaffeinated coffee and spice 

oleoresins (21 CFR 173.290). Under the 

Atomic Energy Act, the Department of 

Energy Worker Safety and Health 

Program requires its contractor 

employees to use the 2005 ACGIH TLV 

for TCE, which is 10 ppm (8-hour TWA) 

and 25 ppm Short Term Exposure Limit. 

Under the Federal Hazardous Material 

Transportation Act, the Department of 

Transportation has designated TCE as a 

hazardous material, and there are 

special requirements for marking, 

labeling, and transporting it (49 CFR 

part 171, 49 CFR part 172, 40 CFR 

173.202, and 40 CFR 173.242). 

6. Significant Alternatives to the 

Proposed Rule 

EPA analyzed alternative regulatory 

approaches to identify which would be 

feasible, reduce burden to small 

businesses, and achieve the objective of 

the statute (i.e., applying one or more 

requirements listed in TSCA section 6(a) 

to the extent necessary so that the 

chemical substance or mixture no longer 

presents an unreasonable risk). As 


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described in more detail in Unit V., EPA 

considered several factors, in addition 

to identified unreasonable risk, when 

selecting among possible TSCA section 

6(a) requirements. To the extent 

practicable, EPA factored into its 

decisions: the effects of TCE on health 

and the environment, 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. As part of this analysis, EPA 

considered—in addition to the 

prohibitions described in Unit V.—a 

wide variety of control measures to 

address the unreasonable risk from TCE 

such as a WCPP, weight fractions, a 

certification and limited access 

program, and prescriptive controls. 

EPA’s analysis of these risk management 

approaches is detailed in Unit V.A.3. In 

general, EPA determined that these 

approaches alone would either not be 

able to address the unreasonable risk, 

or, in the case of a weight fraction limit, 

would result in a product containing so 

little TCE that it would have the effect 

of a prohibition. 

Additionally, in this proposed rule 

and the Economic Analysis, EPA has 

examined a primary alternative 

regulatory action. The primary 

alternative regulatory action described 

in this proposed rule and considered by 

EPA combines prohibitions and 

requirements for a WCPP. While in 

some ways it is similar to the proposed 

regulatory action, the primary 

alternative regulatory action described 

in this NPRM differs from the proposed 

regulatory action by providing longer 

timeframes for prohibitions and by 

describing an ECEL based on a different 

health endpoint (i.e., immunotoxicity), 

as part of the WCPP, for the conditions 

of use of TCE that would be permitted 

to continue for longer than 1 year after 

publication of the final rule until the 

prohibition compliance dates. The 

primary alternative regulatory action 

was considered and found to provide 

greater uncertainty in addressing the 

unreasonable risk from TCE under the 

conditions of use, resulting in EPA’s 

proposed action. Estimated costs of the 

primary alternative regulatory action 

can be found in Chapter 7 of the 

Economic Analysis (Ref. 3). 

As indicated by this overview, and 

detailed in Unit VI.A., in the review of 

alternatives, EPA determined that some 

methods either did not effectively 

eliminate the unreasonable risk 

presented by TCE or, for many 

conditions of use, there was a high 

degree of uncertainty regarding whether 

compliance with a comprehensive 

WCPP would be possible to adequately 

protect potentially exposed persons. 

While EPA is soliciting comments about 

all aspects on the alternative regulatory 

actions, which may be incorporated into 

the final rulemaking, EPA has 

considered the primary alternative 

regulatory action and found that the 

proposed action is more suitable for 

addressing the unreasonable risk to the 

extent necessary so that TCE no longer 

presents such risk, while also allowing 

flexibility for regulated entities to 

continue operations under time-limited 

exemptions, as described in more detail 

in Units V.A. and VI.A. 

Regarding timeframes for compliance, 

as described in Units V.A.1., 2., and 3., 

the proposed compliance dates 

incorporate EPA’s consideration of 

sustained awareness of risks resulting 

from TCE exposure as well as precedent 

established by the OSHA standards (62 

FR 1494, January 10, 1997). TSCA 

requires that EPA propose timeframes 

that are ‘‘as soon as practicable’’ under 

TSCA section 6(d)(1)(B) and 6(d)(1)(D). 

EPA has no information indicating that 

the proposed compliance dates are not 

practicable for the activities that would 

be prohibited, or that additional time is 

needed for products affected by the 

proposed restrictions to clear the 

channels of trade. As noted in Unit IX., 

EPA is seeking public comment on 

whether additional time is needed for 

compliance with prohibitions, for 

products to clear the channels of trade, 

or for implementing a WCPP. EPA may 

finalize shorter or longer compliance 

timeframes based on public comment. 

Regarding potential regulatory 

flexibilities for compliance dates and 

timeframes, EPA notes that the 

alternative regulatory action would 

include longer compliance timeframes 

for prohibitions. Given the potential 

severity of impacts from exposure to 

TCE, EPA’s proposed regulatory action 

would include relatively rapid 

compliance timeframes. However, it is 

possible that longer timeframes would 

be needed for entities to come into 

compliance; therefore, the primary 

alternative regulatory action described 

in the proposed rule would include 

longer timeframes for implementation 

than the proposed regulatory action. 

These timeframes are detailed in Unit 

V.B. 

As required by section 609(b) of the 

RFA, the EPA also convened a SBAR 

Panel to obtain advice and 

recommendations from SERs that 

potentially would be subject to the 

rule’s requirements. The SBAR Panel 

evaluated the assembled materials and 

small-entity comments on issues related 

to elements of an IRFA. A copy of the 

full SBAR Panel Report (Ref. 32) is 

available in the rulemaking docket. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain a Federal 

mandate of $100 million or more as 

described in UMRA, 2 U.S.C. 1531– 

1538, and does not significantly or 

uniquely affect small governments. The 

action would affect entities that use 

TCE. It is not expected to affect State, 

local, or Tribal governments because the 

use of TCE by government entities is 

minimal. This action is not expected to 

result in expenditures by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more (when adjusted 

annually for inflation) in any 1 year. 

Accordingly, this action is not subject to 

the requirements of sections 202, 203, or 

205 of UMRA. 

E. Executive Order 13132: Federalism 

EPA has concluded that this action 

has federalism implications as specified 

in Executive Order 13132 (64 FR 43255, 

August 10, 1999), because regulations 

under TSCA section 6(a) may preempt 

State law. As set forth in TSCA section 

18(a)(1)(B), the issuance of rules under 

TSCA section 6(a) to address the 

unreasonable risk presented by a 

chemical substance has the potential to 

trigger preemption of laws, criminal 

penalties, or administrative actions by a 

State or political subdivision of a State 

that are: (1) Applicable to the same 

chemical substance as the rule under 

TSCA section 6(a); and (2) Designed to 

prohibit or otherwise restrict the 

manufacture, processing, or distribution 

in commerce or use of that same 

chemical. TSCA section 18(c)(3) applies 

that preemption only to the ‘‘hazards, 

exposures, risks, and uses or conditions 

of use’’ of such chemical included in the 

final TSCA section 6(a) rule. 

EPA provides the following 

preliminary federalism summary impact 

statement. The Agency consulted with 

State and local officials early in the 

process of developing the proposed 

action to permit them to have 

meaningful and timely input into its 

development. This included background 

presentation on September 9, 2020, and 

a consultation meeting on July 22, 2021. 

EPA invited the following national 

organizations representing State and 

local elected officials to these meetings: 

Association of State Drinking Water 

Administrators, National Association of 

Clean Water Agencies, Western States 

Water Council, National Water 

Resources Association, American Water 

Works Association, Association of 

Metropolitan Water Agencies, 


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Association of Clean Water 

Administrators, Environmental Council 

of the States, National Association of 

Counties, National League of Cities, 

County Executives of America, U.S. 

Conference of Mayors, and National 

Association of Attorneys General. As 

described in Unit III.A.1., during the 

meeting 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 CWA 

and SDWA. A summary of the meeting 

with these organizations, including the 

views that they expressed, is available 

in the docket (Ref. 26). EPA provided an 

opportunity for these organizations to 

provide follow-up comments in writing 

but did not receive any such comments. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000), because it will not have 

substantial direct effects on Tribal 

governments, on the relationship 

between the Federal Government and 

the Indian Tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

Tribes. This rulemaking would not have 

substantial direct effects on Tribal 

government because TCE is not 

manufactured, processed, or distributed 

in commerce by Tribes. TCE is not 

regulated by Tribes, and this rulemaking 

would not impose substantial direct 

compliance costs on Tribal 

governments. Thus, Executive Order 

13175 does not apply to this action. 

Consistent with the EPA Policy on 

Consultation and Coordination with 

Indian Tribes, EPA consulted with 

Tribal officials during the development 

of this action. The Agency held a Tribal 

consultation from May 17, 2021, to 

August 20, 2021, with meetings on June 

15, 2021, and July 8, 2021. Tribal 

officials were given the opportunity to 

meaningfully interact with EPA risk 

managers concerning the current status 

of risk management. During the 

consultation, EPA discussed risk 

management under TSCA section 6(a). 

EPA risk managers briefed Tribal 

officials on the Agency’s risk 

management considerations and Tribal 

officials raised issues and concerns. 

Issues raised by Tribal officials included 

concerns from Tribal members about the 

TCE OSHA exposure limits being 

outdated, Tribal interest in seeing TCE 

phased out and an interest in reducing 

greenhouse gas emissions, and concerns 

that third party disposal may be 

occurring near Tribal lands, with a 

particular interest in protecting workers 

at publicly owned treatment works. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

Executive Order 13045 (62 FR 19885, 

April 23, 1997) directs Federal agencies 

to include an evaluation of the health 

and safety effects of the planned 

regulation on children in Federal health 

and safety standards and explain why 

the regulation is preferable to 

potentially effective and reasonably 

feasible alternatives. While the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children due to 

TCE’s developmental toxicity, this 

action is not subject to Executive Order 

13045 because it is not a significant 

regulatory action under section 3(f)(1) of 

Executive Order 12866. 

However, EPA’s 2021 Policy on 

Children’s Health applies to this action. 

Information on how the Policy was 

applied is presented in Unit III.A.3. In 

addition, this action’s health and risk 

assessments are contained in Units 

III.B.2., VI.A. and B., and the 2020 Risk 

Evaluation for TCE (section 4 in Ref. 1) 

and the Economic Analysis for this 

proposed rulemaking (Ref. 3). 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211 (66 FR 28355, May 22, 2001) 

because it is not likely to have a 

significant adverse effect on the supply, 

distribution or use of energy. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Pursuant to the NTTAA section 12(d), 

15 U.S.C. 272., the Agency has 

determined that this rulemaking 

involves environmental monitoring or 

measurement, specifically for 

occupational inhalation exposures to 

TCE. Consistent with the Agency’s 

Performance Based Measurement 

System (PBMS), the Agency proposes 

not to require the use of specific, 

prescribed analytic methods. Rather, the 

Agency plans to allow the use of any 

method that meets the prescribed 

performance criteria. The PBMS 

approach is intended to be more flexible 

and cost-effective for the regulated 

community; it is also intended to 

encourage innovation in analytical 

technology and improved data quality. 

EPA is not precluding the use of any 

method, whether it constitutes a 

voluntary consensus standard or not, as 

long as it meets the performance criteria 

specified. 

For this rulemaking, the key 

consideration for the PBMS approach is 

the ability to accurately detect and 

measure airborne concentrations of TCE 

at the ECEL and the ECEL action level. 

Some examples of methods which meet 

the criteria are included in appendix B 

of the ECEL memo (Ref. 46). EPA 

recognizes that there may be voluntary 

consensus standards that meet the 

proposed criteria (Ref. 12). EPA request 

comments on whether it should 

incorporate such voluntary consensus 

standards in the rule and seeks 

information in support of such 

comments regarding the availability and 

applicability of voluntary consensus 

standards that may achieve the 

sampling and analytical requirements of 

the rule in lieu of the PBMS approach. 

EPA requests comment on the degree 

to which additional guidance related to 

use of methods might be necessary. 

J. Executive Orders 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations and 14096: 

Revitalizing Our Nation’s Commitment 

to Environmental Justice for All 

EPA believes that the human health or 

environmental conditions that exist 

prior to this action result in or have the 

potential to result in disproportionate 

and adverse human health or 

environmental effects on communities 

with environmental justice concerns. As 

described more fully in the Economic 

Analysis, EPA conducted an analysis to 

characterize the baseline conditions 

faced by communities and workers 

affected by the regulation to identify the 

potential for disproportionate impacts 

on communities with EJ concerns in 

accordance with Executive Order 12898 

(59 FR 7629, February 16, 1994) and 

Executive Order 14096 (88 FR 25251, 

April 26, 2023). The baseline 

characterization suggests that workers in 

affected industries and regions, as well 

as residents of nearby communities, are 

more likely to be people of color than 

the general population in affected states, 

although this varied by use assessed. 

Based on reasonably available 

information, EPA believes that there are 

potential EJ concerns in communities 

surrounding facilities subject to this 

regulation (Ref. 3). 

EPA believes that this action is likely 

to reduce existing disproportionate and 

adverse effects on communities with 


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environmental justice concerns. While 

the regulatory options are anticipated to 

address the unreasonable risk from 

exposure to TCE to the extent necessary 

so that it is no longer unreasonable, EPA 

is not able to quantify the distribution 

of the change in risk for affected 

populations. EPA is also unable to 

quantify the changes in risks for affected 

populations from non-TCE-using 

technologies or practices that firms may 

adopt in response to the regulation to 

determine whether any such changes 

could pose EJ concerns. Data limitations 

that prevent EPA from conducting a 

more comprehensive analysis are 

summarized in the Economic Analysis 

(Ref. 3). 

EPA additionally identified and 

addressed EJ concerns by conducting 

outreach to advocates of communities 

that might be subject to disproportionate 

exposure to TCE. On June 16, 2021, and 

July 6, 2021, EPA held public meetings 

as part of this consultation (Ref. 32). See 

also Unit III.A.1. Following the EJ 

meetings, EPA received five written 

comments, in addition to oral comments 

provided during the consultations. In 

general, commenters supported strong 

regulation of TCE to protect lowerincome communities and workers. 

Commenters supported strong outreach 

to affected communities, encouraged 

EPA to follow the hierarchy of controls, 

favored prohibitions, and noted the 

uncertainty, and, in some cases, 

inadequacy, of PPE. 

The information supporting the 

review under Executive Order 12898 

and Executive Order 14096 is contained 

in Units I.E., II.D., III.A.1., VI.A., and in 

the Economic Analysis (Ref. 3). EPA’s 

presentations and fact sheets for the EJ 

consultations related to this rulemaking, 

are available at https://www.epa.gov/ 

assessing-and-managing-chemicalsunder-tsca/materials-june-and-july2021-environmental-justice. These 

materials and a summary of the 

consultation are also available in the 

public docket for this rulemaking (Ref. 

32). 

List of Subjects in 40 CFR Part 751 

Environmental protection, Chemicals, 

Export notification, Hazardous 

substances, Import certification, 

Reporting and recordkeeping. 

Michael S. Regan, 

Administrator. 

Therefore, for the reasons stated in the 

preamble, EPA proposes to amend 40 

CFR part 751 as follows: 

PART 751—REGULATION OF CERTAIN 

CHEMICAL SUBSTANCES AND 

MIXTURES UNDER SECTION 6 OF THE 

TOXIC SUBSTANCES CONTROL ACT 

■ 1. The authority citation for part 751 

continues to read as follows: 

Authority: 15 U.S.C. 2605, 15 U.S.C. 

2625(l)(4). 

■ 2. Amend § 751.5 by adding in 

alphabetical order definitions for 

‘‘Authorized person’’, ‘‘ECEL’’, 

‘‘Exposure group’’, ‘‘Owner or 

operator’’, ‘‘Potentially exposed 

person’’, ‘‘Regulated area’’, and 

‘‘Retailer’’ to read as follows: 

§ 751.5 Definitions. 

* * * * * 

Authorized person means any person 

specifically authorized by the owner or 

operator to enter, and whose duties 

require the person to enter a regulated 

area. 

* * * * * 

ECEL is an Existing Chemical 

Exposure Limit and means an airborne 

concentration calculated as an eight (8)- 

hour time-weighted average (TWA). 

* * * * * 

Exposure group means a group 

consisting of every person performing 

the same or substantially similar 

operations in each work shift, in each 

job classification, and in each work area 

where exposure to chemical substances 

or mixtures is reasonably likely to 

occur. 

Owner or operator means any person 

who owns, leases, operates, controls, or 

supervises a workplace covered by this 

part. 

* * * * * 

Potentially exposed person means any 

person who may be occupationally 

exposed to a chemical substance or 

mixture in a workplace as a result of a 

condition of use of that chemical 

substance or mixture. 

Regulated area means an area 

established by the regulated entity to 

demarcate areas where airborne 

concentrations of a specific chemical 

substance exceed, or there is a 

reasonable possibility they may exceed, 

the ECEL or the EPA STEL. 

Retailer means a person who 

distributes in commerce or makes 

available a chemical substance or 

mixture to consumer end users, 

including e-commerce internet sales or 

distribution. Any distributor with at 

least one consumer end user customer is 

considered a retailer. A person who 

distributes in commerce or makes 

available a chemical substance or 

mixture solely to commercial or 

industrial end users or solely to 

commercial or industrial businesses is 

not considered a retailer. 

■ 2. Add new subpart D to read as 

follows: 

Subpart D—Trichloroethylene 

Sec. 

751.301 General. 

751.303 Definitions. 

751.305 Prohibitions of manufacturing, 

processing, distribution in commerce, 

use and disposal. 

751.307 Phaseout of trichloroethylene use 

in manufacture of HFC–134a. 

751.309 Phaseout of trichloroethylene use 

in vapor degreasing for booster rocket 

nozzles. 

751.311 Workplace chemical protection 

program. 

751.313 Downstream notification. 

751.315 Recordkeeping requirements. 

751.317 Exemptions. 

§ 751.301 General. 

This subpart establishes prohibitions 

and restrictions on the manufacture 

(including import), processing, 

distribution in commerce, use, and 

disposal of trichloroethylene (TCE) 

(CASRN 79–01–6) to prevent 

unreasonable risk of injury to health in 

accordance with TSCA section 6(a). 

§ 751.303 Definitions. 

The definitions in subpart A of this 

part apply to this subpart unless 

otherwise specified in this section. In 

addition, the following definitions 

apply: 

Distribute in commerce has the same 

meaning as in section 3 of the Act, 

except that the term does not include 

retailers for purposes of §§ 751.313 and 

751.315. 

ECEL action level means a 

concentration of airborne TCE of 

0.00055 parts per million (ppm) 

calculated as an eight (8)-hour timeweighted average (TWA). 

§ 751.305 Prohibitions of manufacturing, 

processing, distribution in commerce, use 

and disposal. 

(a) Applicability. The provisions of 

this section apply to the following: 

(1) Manufacturing (including 

importing); 

(2) Processing; 

(3) All industrial and commercial 

uses; 

(4) All consumer uses; 

(5) Distribution in commerce; and 

(6) Disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works. 

(b) Prohibitions. (1) After [DATE 3 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], all 

persons are prohibited from 

manufacturing (including importing) 


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TCE, except as specified in paragraphs 

(b)(4) through (13) of this section. 

(2) After [DATE 6 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from processing and distributing in 

commerce (including making available) 

TCE, including any TCE-containing 

products, except as specified in 

paragraphs (b)(4) through (13) of this 

section. 

(3) After [DATE 9 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from industrial and commercial use of 

TCE, including any TCE-containing 

products, except as specified in 

paragraphs (b)(4) through (13) of this 

section. 

(4) After [DATE 6 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from manufacturing (including 

importing) TCE for industrial and 

commercial use for batch vapor 

degreasing in open-top and closed-loop 

degreasing equipment, except for the 

use specified in paragraphs (b)(9) and 

(11) of this section. 

(5) After [DATE 9 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from processing TCE for industrial and 

commercial use for batch vapor 

degreasing in open-top and closed-loop 

degreasing equipment, except for the 

use specified in paragraphs (b)(9) and 

(11) of this section. 

(6) After [DATE 1 YEAR AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from the industrial and commercial use 

of TCE for batch vapor degreasing in 

open-top and closed-loop degreasing 

equipment, except for the use specified 

in paragraphs (b)(9) and (11) of this 

section. 

(7) After [DATE 18 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from manufacturing (including 

importing) TCE for processing of TCE as 

a reactant/intermediate and processing 

TCE for the industrial and commercial 

use of TCE as a processing aid for: 

battery separator manufacturing; process 

solvent used in polymer fiber spinning, 

fluoroelastomer manufacture and 

Alcantara manufacture; extraction 

solvent used in caprolactam 

manufacture; precipitant used in betacyclodextrin manufacture, except for 

those uses specified in paragraphs 

(b)(10) and (12) of this section. 

(8) After [DATE 2 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from processing TCE as a reactant/ 

intermediate and from processing TCE 

for the industrial and commercial use of 

TCE as a 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; precipitant used in betacyclodextrin manufacture, except for 

those uses specified in paragraphs 

(b)(10) and (12) of this section. 

(9) After [DATE 5 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER] all persons are prohibited 

from the industrial and commercial use 

of TCE as a solvent in closed-loop batch 

vapor degreasing for rayon fabric 

scouring for end use in producing rocket 

booster nozzles for Federal agencies and 

their contractors, and manufacturing 

(including importing), processing, and 

distribution in commerce of TCE for 

such use, unless such persons obtain 

and maintain the records required by 

§ 751.309 demonstrating that a final prelaunch test was completed using an 

alternative to TCE in the production of 

the rocket booster nozzles. 

(10) After [DATE 8 YEARS AND 6 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], all 

persons are prohibited from 

manufacturing (including import), 

distribution in commerce, and 

processing of TCE as an intermediate for 

manufacturing hydrofluorocarbon 134-a, 

also known as 1,1,1,2-Tetrafluroethane 

(HFC–134a: CAS Number 811–97–2). 

(11) After [DATE 10 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from the industrial and commercial use 

of TCE as a solvent in closed-loop batch 

vapor degreasing for rayon fabric 

scouring for end use in producing rocket 

booster nozzles for Federal agencies and 

their contractors, and manufacturing 

(including importing), processing, and 

distribution in commerce of TCE for 

such use. 

(12) After [DATE 10 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from the industrial and commercial use 

of TCE as a processing aid for battery 

separatory manufacturing, and the 

manufacturing (including importing), 

processing, and distribution in 

commerce of TCE for such use. 

(13) After [DATE 10 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], for 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 

ordnance 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. 

(14) After [DATE 50 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from industrial and commercial uses of 

TCE for the laboratory uses for essential 

laboratory uses described in 

§ 751.317(b)(1), and from the 

manufacturing (including importing), 

processing, and distribution in 

commerce of TCE for such uses. 

(15) After [DATE 9 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons manufacturing 

(including importing), processing, and 

using TCE are prohibited from disposal 

of TCE to industrial pre-treatment, 

industrial treatment, or publicly owned 

treatment works except as specified in 

paragraph (b)(16) of this section. 

(16) After [DATE 50 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works for the 

purposes of cleanup projects of TCEcontaminated water and groundwater as 

described in § 751.317(b)(2). 


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(17) After [DATE 7 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], all persons are prohibited 

from 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 as described in 

§ 751.317(c)(3) and the manufacturing 

(including importing), processing, and 

distribution in commerce of TCE for 

such use. 

§ 751.307 Phaseout of trichloroethylene 

use in manufacture of HFC–134a. 

(a) Baseline. Before [DATE 6 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], each 

manufacturer of HFC–134a who 

processes TCE as an intermediate must 

establish a baseline annual volume of 

TCE processed as an intermediate. 

(1) The manufacturer must use the 

average of any 12 consecutive months in 

the 36 months preceding [DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER] to 

calculate the baseline. 

(2) The manufacturer must retain 

records that demonstrate how the 

baseline annual volume was calculated, 

in accordance with § 751.315(d)(1). 

(b) Phaseout. (1) Beginning [DATE 2 

YEARS AND 6 MONTHS AFTER DATE 

OF PUBLICATION OF THE FINAL 

RULE IN THE FEDERAL REGISTER], 

each manufacturer of HFC–134a who 

processes TCE as an intermediate is not 

permitted to process TCE as an 

intermediate at an annual volume 

greater than 75 percent of the baseline. 

(2) Beginning [DATE 4 YEARS AND 

6 MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], each 

manufacturer of HFC–134a who 

processes TCE as an intermediate is not 

permitted to processes TCE as an 

intermediate at an annual volume 

greater than 50 percent of the baseline. 

(3) Beginning [DATE 6 YEARS AND 

6 MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], each 

manufacturer of HFC–134a who 

processes TCE as an intermediate is not 

permitted to processes TCE as an 

intermediate at an annual volume 

greater than 25 percent of the baseline 

so established. 

(4) Beginning [DATE 8 YEARS AND 

6 MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], each 

manufacturer of HFC–134a who 

processes TCE as an intermediate is 

prohibited from processing TCE as an 

intermediate. 

(c) Workplace chemical protection 

program. All persons using TCE in 

accordance with this section must 

comply with § 751.311. 

§ 751.309 Phaseout of trichloroethylene 

use in vapor degreasing for booster rocket 

nozzles. 

(a) In accordance with § 751.305(b)(9), 

until [DATE 5 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], TCE 

may be manufactured (including 

imported), processed, distributed in 

commerce, and used as a solvent in 

closed-loop batch vapor degreasing for 

rayon fabric scouring for end use in 

rocket booster nozzle production by 

Federal agencies and their contractors. 

(b) From [DATE 5 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER] until [DATE 10 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER], TCE may only be 

manufactured (including imported), 

processed, distributed in commerce, and 

used as a solvent in closed-loop batch 

vapor degreasing for rayon fabric 

scouring, for end use in rocket booster 

nozzle production by Federal agencies 

and their contractors by persons who 

maintain records demonstrating that a 

final pre-launch test of rocket booster 

nozzles without using TCE was 

completed. 

(c) All persons using TCE in 

accordance with this section must 

comply with § 751.311. 

§ 751.311 Workplace chemical protection 

program. 

(a) Applicability. The provisions of 

this section apply to workplaces 

engaged in the following conditions of 

use of TCE that are allowed to 

temporarily continue past one year, in 

accordance with § 751.305(b)(4) through 

(13), § 751.307, and § 751.309: 

(1) Manufacturing (domestic 

manufacture); 

(2) Manufacturing (import); 

(3) Processing as a reactant/ 

intermediate; 

(4) Processing into formulation, 

mixture or reaction product; 

(5) Processing (repackaging); 

(6) Processing (recycling); 

(7) Industrial and commercial use as 

a 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; precipitant used in betacyclodextrin manufacture; 

(8) Industrial and commercial use in 

other miscellaneous industrial and 

commercial uses (laboratory use for 

essential laboratory activities); 

(9) Industrial and commercial use of 

TCE as a solvent in closed-loop batch 

vapor degreasing for rayon fabric 

scouring for end use in rocket booster 

nozzle production by Federal agencies 

and their contractors; 

(10) Disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works for the 

purposes of cleanup projects of TCEcontaminated water and groundwater; 

(11) Industrial and commercial use of 

TCE for DoD naval vessels and their 

systems, and in the maintenance, 

fabrication, and sustainment for and of 

such vessels and systems; 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 ordnance 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; and 

(12) 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. 

(b) Existing chemical exposure limit 

(ECEL). (1) Applicability. The 

provisions of this paragraph (b) apply to 

any workplace engaged in the 

conditions of use listed in paragraphs 

(a)(1) through (9) of this section. 

(2) ECEL. Beginning [DATE 9 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], or 

beginning 4 months after introduction of 

TCE into the workplace if TCE use 

commences after [DATE 6 MONTHS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER], the owner or operator must 

ensure to the extent possible that no 

person is exposed to an airborne 


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concentration of TCE in excess of 1.1 

parts of TCE per billion parts of air 

(0.0011 ppm) as an eight (8)-hour TWA, 

in accordance with the requirements of 

paragraph (c) of this section and, if 

necessary, paragraph (e) of this section: 

(3) Exposure monitoring—(i) General. 

(A) Owners or operators must determine 

each potentially exposed person’s 

exposure by either: 

(1) Taking a personal breathing zone 

air sample of each potentially exposed 

person’s exposure; or 

(2) Taking personal breathing zone air 

samples that are representative of the 8- 

hour TWA of each person whose 

exposure must be monitored. 

(B) Representative 8-hour TWA 

exposures must be determined on the 

basis of one or more full-shift exposure 

of at least one person that represents, 

and does not underestimate, the 

potential exposure of every person in 

each exposure group and that represents 

the highest TCE exposures likely to 

occur under reasonably foreseeable 

conditions of use. 

(C) Exposure samples must be 

analyzed using an appropriate analytical 

method by a laboratory that complies 

with the Good Laboratory Practice 

Standards in 40 CFR part 792. 

(D) Owners or operators must ensure 

that methods used to perform exposure 

monitoring produce results that are 

accurate, to a confidence level of 95 

percent, to within plus or minus 25 

percent for airborne concentrations of 

TCE. 

(ii) Initial monitoring. (A) Each owner 

or operator who has a workplace or 

work operation covered by this section, 

except as provided for in paragraph 

(b)(3)(ii)(B) of this section, must perform 

initial monitoring of potentially exposed 

persons regularly working in areas 

where TCE is present. 

(B) The initial monitoring required in 

paragraph (b)(3)(ii)(A) of this section 

must be completed by [DATE 6 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER] or within 

30 days of introduction of TCE into the 

workplace, whichever is later. Where 

the owner or operator has monitoring 

within five years prior to [DATE 2 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER] and the 

monitoring satisfies all other 

requirements of this section, the owner 

or operator may rely on such earlier 

monitoring results to satisfy the 

requirements of paragraph (b)(3)(ii)(A) 

of this section. 

(iii) Periodic monitoring. The owner 

or operator must establish an exposure 

monitoring program for periodic 

monitoring of exposure to TCE in 

accordance with Table 1 to this 

paragraph (b)(3)(iii). 

TABLE 1 TO PARAGRAPH (b)(3)(iii)—PERIODIC MONITORING REQUIREMENTS

Air concentration condition Periodic monitoring requirement 

If all initial exposure monitoring is below the ECEL action level 

(<0.00055 ppm 8-hour TWA).

Periodic exposure monitoring is required at least once every 5 years. 

If the initial or most recent exposure monitoring indicates that airborne 

exposure is above the ECEL (>0.0011 ppm 8-hour TWA).

Periodic exposure monitoring is required within 3 months of the most 

recent exposure monitoring. 

If the initial or most recent exposure monitoring indicates that airborne 

exposure is at or above the ECEL action level but at or below the 

ECEL (≥0.00055 ppm 8-hour TWA, ≤0.0011 ppm 8-hour TWA).

Periodic exposure monitoring is required within 6 months of the most 

recent exposure monitoring. 

If the two most recent (non-initial) exposure monitoring measurements, 

taken at least seven days apart, indicate that airborne exposure is 

below the ECEL action level (<0.00055 ppm 8-hour TWA).

Periodic exposure monitoring is required within 5 years of the most recent exposure monitoring. 

If the owner or operator engages in a condition of use for which compliance with the WCPP would be required but does not manufacture, 

process, use, or dispose of TCE in that condition of use over the entirety of time since the last required monitoring event.

The owner or operator may forgo its current periodic monitoring event. 

However, documentation of cessation of use of TCE as well as periodic monitoring would be required when the owner or operator resumes any of the conditions of use for which compliance with the 

WCPP is proposed. 

(iv) Additional monitoring. (A) The 

owner or operator must conduct 

additional initial exposure monitoring 

whenever there has been a change in the 

production, process, control equipment, 

personnel or work practices that may 

reasonably be expected to result in new 

or additional exposures above the ECEL 

action level or when the owner or 

operator has any reason to believe that 

new or additional exposures above the 

ECEL action level have occurred. 

(B) Whenever start-ups, shutdown, 

spills, leaks, ruptures, or other 

breakdowns occur that may lead to 

exposure to potentially exposed 

persons, the owner or operator must 

conduct additional initial exposure 

monitoring (using personal breathing 

zone sampling) after the cleanup of the 

spill or repair of the leak, rupture, or 

other breakdown. 

(v) Notification of monitoring results. 

(A) The owner or operator must inform 

persons whose exposures are 

represented by the monitoring of the 

monitoring results within 15 working 

days. 

(B) This notification must include the 

following: 

(1) Exposure monitoring method(s) 

and results; 

(2) Identification and explanation of 

the ECEL and ECEL action level in plain 

language; 

(3) Any corresponding required 

respiratory protection as described in 

paragraph (e) of this section; 

(4) Descriptions of actions taken by 

the regulated entity to reduce exposure 

to or below the ECEL; 

(5) Quantity of TCE in use; 

(6) Location of TCE use; 

(7) Manner of TCE use; 

(8) Identified releases of TCE; and 

(9) Whether the airborne 

concentration of TCE exceeds the ECEL. 

(C) Notice must be provided in plain 

language writing, in a language that the 

person understands, to each potentially 

exposed person or posted in an 

appropriate and accessible location 

outside the regulated area with an 

English-language version and a nonEnglish language version representing 

the language of the largest group of 

workers who do not read English. 

(4) Regulated areas. (i) Beginning 

[DATE 9 MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], 

beginning 4 months after introduction of 

trichloroethylene into the workplace if 

trichloroethylene use commences after 

[DATE 6 MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], owners 

or operators must establish a regulated 


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area wherever any person’s exposure to 

airborne concentrations of TCE exceeds 

or can reasonably be expected to exceed 

the ECEL. 

(ii) The owner or operator must limit 

access to regulated areas to authorized 

persons. 

(iii) The owner or operator must 

demarcate regulated areas from the rest 

of the workplace in a manner that 

adequately establishes and alerts 

persons to the boundaries of the area 

and minimizes the number of 

authorized persons exposed to TCE 

within the regulated area. 

(iv) The owner or operator must 

supply a respirator that complies with 

the requirements of paragraph (e) of this 

section and must ensure that all persons 

within the regulated area are using the 

provided respirators whenever TCE 

exposures may exceed the ECEL. 

(v) An owner or operator who has 

implemented all feasible engineering, 

work practice and administrative 

controls as required in paragraph 

(c)(1)(i) of this section, and who has 

established a regulated area as required 

by paragraph (b)(4)(i) of this section 

where TCE exposure exceeds or can 

reasonably be expected to exceed the 

ECEL only on certain days (for example, 

because of work or process schedule) 

must have persons use respirators in 

that regulated area on those days. 

(vi) The owner or operator must 

ensure that, within a regulated area, 

persons do not engage in non-work 

activities which may increase TCE 

exposure. 

(vii) The owner or operator must 

ensure that while persons are wearing 

respirators in the regulated area, they do 

not engage in activities which interfere 

with respirator seal or performance. 

(c) ECEL control procedures and 

plan—(1) Methods of compliance. The 

owner or operator must institute one or 

a combination of elimination, 

substitution, engineering controls or 

administrative controls to reduce 

exposure to or below the ECEL except 

to the extent that the owner or operator 

can demonstrate that such controls are 

not feasible as an interim measure. 

Wherever the feasible exposure controls, 

including one or a combination of 

elimination, substitution, engineering 

controls or administrative controls, 

which can be instituted are not 

sufficient to reduce exposure at or 

below the ECEL, the owner or operator 

must use them to reduce exposure to the 

lowest levels achievable by these 

controls and must supplement them by 

the use of respiratory protection that 

complies with the requirements of 

paragraph (e) of this section. Where an 

owner or operator cannot demonstrate 

exposure below the ECEL or exposure at 

the lowest achievable level for the 

facility, including through the use of 

engineering controls or work practices, 

and has not demonstrated that it has 

supplemented feasible exposure 

controls with respiratory protection, this 

will constitute a failure to comply with 

the ECEL. The owner or operator must 

maintain the effectiveness of 

engineering controls or administrative 

controls instituted under paragraph 

(d)(1)(i)(A) of this section. The owner or 

operator must not implement a schedule 

of personnel rotation as a means of 

compliance with the ECEL. The owner 

or operator must document their 

exposure control strategy and 

implementation in an exposure control 

plan in accordance with paragraph 

(d)(2) of this section. 

(2) Exposure control plan 

requirements. If any monitoring 

conducted in accordance with 

paragraph (b)(3) of this section shows 

worker exposures at or above the ECEL 

action level in the workplace, the owner 

or operator, within [DATE 12 MONTHS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER], must include and 

document in an exposure control plan 

the following: 

(i) Identification and rationale of 

exposure controls used or not used as a 

time-limited measure in the following 

sequence: elimination of TCE, 

substitution of TCE, engineering 

controls and administrative controls to 

reduce exposures in the workplace to 

either at or below the ECEL or to the 

lowest achievable level of TCE in the 

workplace; 

(ii) The exposure controls selected 

based on feasibility, effectiveness, and 

other relevant considerations; 

(iii) If exposure controls were not 

selected, document the efforts 

identifying why these are not feasible, 

not effective, or otherwise not 

implemented; 

(iv) Actions taken to implement 

exposure controls selected, including 

proper installation, maintenance, 

training or other steps taken; 

(v) Description of any regulated area 

and how it is demarcated, and 

identification of authorized persons; 

and description of when the owner or 

operator expects exposures may be 

likely to exceed the ECEL or lowest 

achievable exposure level; 

(vi) Identification of the lowest 

achievable exposure level and why 

further reductions are not possible; 

(vii) Regular inspections, evaluations, 

and updating of the exposure controls to 

ensure effectiveness and confirmation 

that all persons are implementing them 

as required until the prohibition 

compliance date; 

(viii) Occurrence and duration of any 

start-up, shutdown, or malfunction of 

the facility that causes air 

concentrations to be above the ECEL or 

lowest achievable exposure level and 

subsequent corrective actions taken 

during start-up, shutdown, or 

malfunctions to mitigate exposures to 

TCE; and 

(ix) Availability of the exposure 

control plan and associated records for 

potentially exposed persons. 

(d) Workplace information and 

training. (1) The owner or operator must 

provide information and training for 

each person prior to or at the time of 

initial assignment to a job involving 

potential exposure to TCE. 

(2) The owner or operator must ensure 

that information and training is 

presented in a manner that is 

understandable to each person required 

to be trained. 

(3) The following information and 

training must be provided to all persons 

assigned to a job involving potential 

exposure to TCE: 

(i) The requirements of this section, as 

well as how to access or obtain a copy 

of these requirements in the workplace; 

(ii) The quantity, location, manner of 

use, release, and storage of TCE and the 

specific operations in the workplace 

that could result in exposure to TCE, 

particularly noting where exposures 

may be above the ECEL; 

(iii) Methods and observations that 

may be used to detect the presence or 

release of TCE in the workplace (such as 

monitoring conducted by the owner or 

operator, continuous monitoring 

devices, visual appearance or odor of 

TCE when being released, etc.); 

(iv) The health hazards of TCE in the 

workplace; and 

(v) The principles of safe use and 

handling of TCE and measures 

potentially exposed persons can take to 

protect themselves from TCE, including 

specific procedures the owner or 

operator has implemented to protect 

potentially exposed persons from 

exposure to TCE, such as appropriate 

work practices, emergency procedures, 

and personal protective equipment to be 

used. 

(4) The owner or operator must retrain each potentially exposed person 

annually to ensure that each such 

person maintains the requisite 

understanding of the principles of safe 

use and handling of TCE in the 

workplace. 

(5) Whenever there are workplace 

changes, such as modifications of tasks 

or procedures or the institution of new 

tasks or procedures, which increase 


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exposure, and where those exposures 

exceed or can reasonably be expected to 

exceed the ECEL action level, the owner 

or operator must update the training as 

necessary to ensure that each potentially 

exposed person has the requisite 

proficiency. 

(e) Personal protective equipment 

(PPE)—(1) Applicability. The provisions 

of this paragraph (e) apply to any owner 

or operator that is required to provide 

respiratory protection or dermal 

protection pursuant to paragraphs (c)(1) 

and (d) of this section. 

(2) Selection. PPE, including 

respiratory and dermal protection, that 

is of safe design and construction for the 

work to be performed must be provided, 

used, and maintained in a sanitary, 

reliable, and undamaged condition. 

Owners and operators must select PPE 

that properly fits each affected person 

and communicate PPE selections to 

each affected person. 

(3) Respiratory protection. (i) After 3 

months of receipt of any exposure 

monitoring or within [DATE 9 

MONTHS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], the 

owner or operators must supply a 

respirator, selected in accordance with 

this paragraph, to each person who 

enters a regulated area and must ensure 

that all persons within the regulated 

area are using the provided respirators 

whenever TCE exposures may exceed 

the ECEL. 

(ii) Owners or operators must provide 

respiratory protection in accordance 

with the provisions outlined in 29 CFR 

1910.134(a) through (l) (except 

(d)(1)(iii)) and as specified in this 

paragraph for persons exposed or who 

may be expose to TCE in concentrations 

above the ECEL. For the purpose of this 

paragraph (e), the maximum use 

concentration (MUC) as used in 29 CFR 

1910.134 must be calculated by 

multiplying the assigned protection 

factor (APF) specified for a respirator by 

the ECEL. For the purposes of this 

paragraph (e), provisions in 29 CFR 

1910.134(a) through (l) (except 

(d)(1)(iii)) applying to an ‘‘employee’’ 

also apply equally to potentially 

exposed persons, and provisions 

applying to an ‘‘employer’’ also apply 

equally to owners or operators. 

(iii) Owners or operators must select 

and provide to persons appropriate 

respirators as indicated by the most 

recent monitoring results, as follows: 

(A) If the measured exposure 

concentration is at or below 0.0011 ppm 

(1.1 ppb): no respiratory protection is 

required. 

(B) If the measured exposure 

concentration is above 0.0011 ppm (1.1 

ppb) and less than or equal to 0.0055 

ppm (5.5 ppb) (5 times ECEL): Any 

National Institute for Occupational 

Safety and Health (NIOSH)-certified airpurifying quarter mask respirator (APF 

5). 

(C) If the measured exposure 

concentration is above 0.0055 ppm (5.5 

ppb) and less than or equal to 0.011 

ppm (110 ppb) (10 times ECEL): Any 

NIOSH-certified air-purifying half mask 

or full facepiece respirator equipped 

with NIOSH-approved organic vapor 

cartridges or canisters (APF 10). 

(D) If the measured exposure 

concentration is above 0.011 ppm (11.0 

ppb) and less than or equal to 0.0275 

ppm (27.5 ppb) (25 times ECEL): Any 

NIOSH-certified air-purifying full 

facepiece respirator equipped with 

NIOSH-approved organic vapor 

cartridges or canisters; any NIOSHcertified powered air-purifying 

respirator equipped with NIOSHapproved organic vapor cartridges; or 

any NIOSH-certified continuous flow 

supplied air respirator equipped with a 

hood or helmet (APF 25). 

(E) If the measured exposure 

concentration is above 0.0275 ppm (27.5 

ppb) and less than or equal to 0.055 

ppm (55.0 ppb) (50 times ECEL): Any 

NIOSH-certified air-purifying full 

facepiece respirator equipped with 

NIOSH-approved organic vapor 

cartridges or canisters; or any NIOSHcertified powered air-purifying 

respirator equipped with a tight-fitting 

half facepiece and a NIOSH-approved 

organic vapor cartridges or canisters; 

any NIOSH-certified negative pressure 

(demand mode) supplied-air respirator 

equipped with a full facepiece; any 

NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

tight-fitting half facepiece; any NIOSHcertified supplied air respirator 

equipped with a half facepiece and 

operated in a pressure demand or other 

positive pressure mode; or any NIOSHcertified negative pressure (demand 

mode) self-contained breathing 

apparatus respirator equipped with a 

full facepiece (APF 50). 

(F) If the measured exposure 

concentration is above 0.055 ppm (55.0 

ppb) and less than or equal to 1.1 ppm 

(1,100 ppb) (1,000 times ECEL): Any 

NIOSH-certified powered air-purifying 

respirator equipped with a full facepiece 

and NIOSH-approved organic vapor 

cartridges or canisters; any NIOSHcertified supplied air respirator 

equipped with a full facepiece and 

operated in a continuous flow mode or 

pressure demand or other positive 

pressure mode (APF 1,000). 

(G) If the measured exposure 

concentration is greater than 1.1 ppm 

(1,100 ppb) (1,000 times ECEL) or the 

concentration is unknown: Any NIOSHcertified self-contained breathing 

apparatus equipped with a full 

facepiece and operated in a pressure 

demand or other positive pressure 

mode; or any NIOSH-certified supplied 

air respirator equipped with a full 

facepiece and operated in a pressure 

demand or other positive pressure mode 

in combination with an auxiliary selfcontained breathing apparatus operated 

in a pressure demand or other positive 

pressure mode (APF 10,000). 

(iv) The respiratory protection 

requirements in this paragraph 

represent the minimum respiratory 

protection requirements, such that any 

respirator affording a higher degree of 

protection than the required respirator 

may be used. 

(v) When a person whose job requires 

the use of a respirator cannot use a 

negative-pressure respirator, the owner 

or operator must provide that person 

with a respirator that has less breathing 

resistance than the negative-pressure 

respirator, such as a powered airpurifying respirator or supplied-air 

respirator, when the person is able to 

use it and if it provides the person with 

adequate protection. 

(vi) Owners or operators must 

document the notice to and ability of 

any potentially exposed person to 

access the exposure control plan and 

other associated records. 

(4) Dermal protection. The owner or 

operator must supply and require the 

donning of gloves that are chemically 

resistant to TCE with activity-specific 

training where dermal contact with TCE 

is possible, after application of the 

requirements in paragraph (e) of this 

section, in accordance with the 

hierarchy of controls. 

(5) PPE training. (i) Owners and 

operators must provide PPE training in 

accordance with 29 CFR 1910.132(f) to 

all persons required to use PPE prior to 

or at the time of initial assignment to a 

job involving potential exposure to TCE. 

For the purposes of this paragraph 

(e)(5)(i), provisions in 29 CFR 

1910.132(f) applying to an ‘‘employee’’ 

also apply equally to potentially 

exposed persons, and provisions 

applying to an ‘‘employer’’ also apply 

equally to owners or operators. 

(ii) Owners and operators must retrain 

each potentially exposed person 

required to use PPE annually or 

whenever the owner or operator has 

reason to believe that a previously 

trained person does not have the 

required understanding and skill to 

properly use PPE, or when changes in 

the workplace or in PPE to be used 

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§ 751.313 Downstream notification. 

(a) Beginning on [DATE 2 MONTHS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER], each person who 

manufactures (including imports) TCE 

for any use must, prior to or concurrent 

with the shipment, notify companies to 

whom TCE is shipped, in writing, of the 

restrictions described in this subpart in 

accordance with paragraph (c) of this 

section. 

(b) Beginning on [DATE 6 MONTHS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER], each person who processes 

or distributes in commerce TCE or any 

TCE-containing products for any use 

must, prior to or concurrent with the 

shipment, notify companies to whom 

TCE is shipped, in writing, of the 

restrictions described in this subpart in 

accordance with paragraph (c) of this 

section. 

(c) The notification required under 

paragraphs (a) and (b) of this section 

must occur by inserting the following 

text in section 1(c) and 15 of the Safety 

Data Sheet (SDS) provided with the TCE 

or with any TCE-containing product: 

After [DATE 6 MONTHS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], this chemical/product is 

and can only be distributed in 

commerce or processed for the 

following purposes until the following 

prohibitions take effect: (1) Processing 

as an intermediate; a) for the 

manufacture of HFC–134a until [DATE 

8.5 YEARS AFTER DATE OF 

PUBLICATION OF FINAL RULE IN 

THE FEDERAL REGISTER] and b) for 

all other processing as a reactant/ 

intermediate until [DATE 2 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER]; (2) Industrial and 

commercial use as a solvent for opentop batch vapor degreasing until [DATE 

1 YEAR AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]; (3) 

Industrial and commercial use as a 

solvent for closed-loop batch vapor 

degreasing until [DATE 1 YEAR AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER], except for industrial and 

commercial use as a solvent for closedloop batch vapor degreasing necessary 

for human-rated rocket engine cleaning 

by NASA and its contractors until 

[DATE 7 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER], and 

except 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 until [DATE 10 

YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]; (4) 

Industrial and commercial use as a 

processing aid in: a) battery separator 

manufacturing until [DATE 10 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER] and b) process solvent used 

in polymer fiber spinning, 

fluoroelastomer manufacture and 

Alcantara manufacture; extraction 

solvent used in caprolactam 

manufacture; precipitant used in betacyclodextrin manufacture until [DATE 2 

YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]; (5) 

Industrial and commercial uses for DoD 

naval vessels and their systems, and in 

the maintenance, fabrication, and 

sustainment for and of such vessels and 

systems until [DATE 10 YEARS AFTER 

DATE OF PUBLICATION OF THE 

FINAL RULE IN THE FEDERAL 

REGISTER]; and (6) Industrial and 

commercial use for laboratory use for 

essential laboratory activities until 

[DATE 50 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. 

§ 751.315 Recordkeeping requirements. 

(a) General records. After [DATE 60 

DAYS AFTER DATE OF PUBLICATION 

OF THE FINAL RULE IN THE 

FEDERAL REGISTER], all persons who 

manufacture, process, distribute in 

commerce, or engage in industrial or 

commercial use of TCE or TCEcontaining products must maintain 

ordinary business records, such as 

invoices and bills-of-lading related to 

compliance with the prohibitions, 

restrictions, and other provisions of this 

subpart. 

(b) Workplace chemical protection 

program compliance—(1) ECEL 

exposure monitoring. For each 

monitoring event of TCE, owners or 

operators subject to the ECEL described 

in § 751.311(b) must document the 

following: 

(i) Dates, duration, and results of each 

sample taken; 

(ii) All measurements that may be 

necessary to determine the conditions 

that may affect the monitoring results; 

(iii) Identification of all persons 

represented by the representative 

sampling monitoring, indicating which 

persons were actually monitored; 

(iv) Name, workplace address, work 

shift, job classification, and work area of 

the person monitored; documentation of 

all potentially exposed persons whose 

exposures the monitoring is intended to 

represent if using a representative 

sample; and type of respiratory 

protective device worn by the 

monitored person, if any; 

(v) Use of appropriate sampling and 

analytical methods, such as analytical 

methods already approved by EPA, 

Occupational Safety and Health 

Administration (OSHA) or NIOSH, or 

compliance with an analytical method 

verification procedure; 

(vi) Compliance with the Good 

Laboratory Practice Standards in 

accordance with 40 CFR part 792; and 

(vii) Information regarding air 

monitoring equipment, including: type, 

maintenance, calibrations, performance 

tests, limits of detection, and any 

malfunctions. 

(2) ECEL compliance. Owners or 

operators subject to the ECEL described 

in § 751.311(b) must retain records of: 

(i) Exposure control plan as described 

in § 751.311(d)(2); 

(ii) Facility exposure monitoring 

records; 

(iii) Notifications of exposure 

monitoring results; 

(iv) The name, workplace address, 

work shift, job classification, work area 

and respiratory protection used by each 

potentially exposed person and PPE 

program implementation, as described 

in § 751.311(e), including fit-testing and 

training; and 

(v) Information and training provided 

by the regulated entity to each person 

prior described in paragraph 

§ 751.311(d) and (e). 

(c) Records related to § 751.317 

exemptions. To maintain eligibility for 

an exemption described in § 751.317, 

owners or operators must maintain 

records demonstrating compliance with 

the specific conditions of the 

exemption. 

(d) Records related to §§ 751.307 and 

751.309 phaseouts. (1) Each 

manufacturer of HFC–134a who uses 

TCE as an intermediate must maintain 

records of the annual quantity of TCE 

purchased and processed from the year 

2023 until the termination of all 

processing of TCE as an intermediate. 

(2) Each person using TCE under 

§ 751.309 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, must maintain 

records demonstrating that the end use 

is in rocket booster nozzle production 

for Federal agencies and their 

contractors. 

(3) After [DATE 5 YEARS AFTER 

DATE OF PUBLICATION OF FINAL 

RULE IN THE FEDERAL REGISTER], 


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each person using TCE under § 751.309 

for industrial and commercial use as a 

solvent for closed-loop batch vapor 

degreasing, specifically for rayon fabric 

scouring, must maintain records that 

demonstrate that a final pre-launch test 

of rocket booster nozzles without using 

TCE was completed. 

(e) Minimum record retention periods. 

(1) The records required under 

paragraphs (a) through (c) of this section 

must be retained for at least 5 years from 

the date that such records were 

generated. 

(2) The records required under 

paragraph (d) of this section must be 

retained for at least 5 years after the use 

of TCE has ceased. 

§ 751.317 Exemptions. 

(a) In general. (1) The time-limited 

exemptions established in 

§ 751.305(b)(12) and (13) are established 

in accordance with 15 U.S.C. 2605(g). 

(2) In order to be eligible for the 

exemptions, regulated parties must 

comply with all conditions established 

for such exemptions in accordance with 

15 U.S.C. 2605(g)(4). 

(b) Exemptions under 15 U.S.C. 

2605(g)(1)(A). (1) Laboratory use for 

essential laboratory activities until 

[DATE 50 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. The 

following are specific conditions of the 

exemption for laboratory use at 

§ 751.305(b)(13): 

(i) The industrial and commercial use 

of TCE as a laboratory chemical must 

only be for the following: 

(A) Essential laboratory activities, 

including chemical analysis, chemical 

synthesis, extracting or purifying other 

chemicals, dissolving other substances, 

and research and development for the 

advancement of cleanup activities and 

analytical methods for monitoring 

related to TCE contamination or 

exposure monitoring. 

(B) Federal agencies and their 

contractors conducting research and 

development activities and test and 

evaluation method activities, other than 

those described in paragraph (b)(1)(i)(A) 

of this section, and similar laboratory 

activities, provided the use is essential 

to the agency’s mission. 

(ii) TCE must not be used as a 

laboratory chemical for testing asphalt. 

(iii) The use of TCE as a laboratory 

chemical must be performed on the 

premises of industrial or commercial 

laboratories. 

(iv) The owner or operator of the 

location where such use of TCE occurs, 

and manufacturers (including 

importers) and processors of TCE for 

such use, must comply with the 

Workplace Chemical Protection Program 

provisions in § 751.311. 

(v) The owner or operator of the 

location where such use of TCE occurs 

must comply with the recordkeeping 

requirements in § 751.315. 

(2) Disposal of TCE to industrial pretreatment, industrial treatment, or 

publicly owned treatment works for the 

purposes of cleanup projects of TCEcontaminated water and groundwater 

until [DATE 50 YEARS AFTER DATE 

OF PUBLICATION OF THE FINAL 

RULE IN THE FEDERAL REGISTER]. 

The following are specific conditions of 

the exemption for disposal at 

§ 751.305(b)(15): 

(i) The disposal of TCE to industrial 

pre-treatment, industrial treatment, or 

publicly owned treatment works must 

only be for the purposes of cleanup 

projects of TCE-contaminated water and 

groundwater. The disposal of TCE to 

industrial pre-treatment, industrial 

treatment, or publicly owned treatment 

works is limited to only sites 

undergoing remediation under CERCLA, 

RCRA, or other Federal, state, and local 

government laws, regulations, or 

requirements. 

(ii) The owner or operator of the 

location where workers are handling 

TCE wastewater, and owners or 

operators of facilities where TCE is 

disposed to industrial pre-treatment, 

industrial treatment, or publicly owned 

treatment works, must comply with the 

Workplace Chemical Protection Program 

provisions in § 751.311. 

(iii) The owner or operator of the 

location where such use of TCE occurs 

must comply with the recordkeeping 

requirements in § 751.315. 

(3) Use of TCE or TCE-containing 

products for the specific conditions of 

use identified in paragraph (b)(3)(i) of 

this section in an emergency by the 

National Aeronautics and Space 

Administration (NASA) and its 

contractors operating within the scope 

of their contracted work until [DATE 10 

YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. 

(i) Applicability. The emergency use 

exemption described in this paragraph 

(b)(3) applies to the following specific 

conditions of use as described in 

paragraph (b)(3)(i)(A) of this section. 

(A) Conditions of use subject to this 

exemption—(1) Industrial and 

commercial use as solvent for open-top 

or closed-loop batch vapor degreasing. 

(2) Industrial and commercial use as 

solvent for cold cleaning. 

(3) Industrial and commercial use as 

a solvent for aerosol spray degreaser/ 

cleaner and mold release. 

(4) Industrial and commercial use as 

a lubricant and grease in tap and die 

fluid. 

(5) Industrial and commercial use as 

a lubricant and grease in penetrating 

lubricant. 

(6) Industrial and commercial use as 

an adhesive and sealant in solventbased adhesives and sealants. 

(7) Industrial and commercial as a 

functional fluid in heat exchange fluid. 

(8) Industrial and commercial use in 

corrosion inhibitors and anti-scaling 

agents. 

(9) Industrial and commercial use of 

TCE as a processing aid. 

(B) Emergency use—(1) In general. An 

emergency is a serious and sudden 

situation requiring immediate action, 

within 15 days or less, necessary to 

protect: 

(i) Safety of NASA’s or their 

contractors’ personnel; 

(ii) NASA’s missions; 

(iii) Human health, safety, or property, 

including that of adjacent communities; 

or 

(iv) The environment. 

(2) Duration. Each emergency is a 

separate situation; if use of TCE exceeds 

15 days, then justification must be 

documented. 

(3) Eligibility. To be eligible for the 

exemption, the NASA and its 

contractors must: 

(i) Select TCE because there are no 

technically and economically feasible 

safer alternatives available during the 

emergency. 

(ii) Perform the emergency use of TCE 

at locations controlled by NASA or its 

contractors. 

(ii) Requirements. To be eligible for 

the emergency use exemption described 

in this paragraph (b)(3), the NASA and 

its contractors must comply with the 

following conditions: 

(A) Notification. Within 15 working 

days of the emergency use by NASA and 

its contractors, NASA must provide 

notice to EPA that includes the 

following: 

(1) Identification of the conditions of 

use detailed in paragraph (b)(3)(i)(A) of 

this section that the emergency use fell 

under; 

(2) An explanation for why the 

emergency use met the definition of 

emergency in paragraph (b)(3)(i)(B) of 

this section; and 

(3) An explanation of why TCE was 

selected, including why there were no 

technically and economically feasible 

safer alternatives available in the 

particular emergency. 

(B) Exposure control. The owner or 

operator must comply with the 

Workplace Chemical Protection Program 

provisions in § 751.311, to the extent 


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74794 Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Proposed Rules 

technically feasible in light of the 

particular emergency. 

(C) Recordkeeping. The owner or 

operator of the location where the use 

takes place must comply with the 

recordkeeping requirements in 

§ 751.315. 

(c) Exemptions under 15 U.S.C. 

2605(g)(1)(B)—(1) Lead-acid and lithium 

battery separator manufacturing until 

[DATE 10 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE IN 

THE FEDERAL REGISTER]. The 

following are specific conditions of the 

exemption for use as a processing aid in 

the manufacturing of lead-acid and 

lithium battery separators at 

§ 751.305(b)(12): 

(i) The use of TCE as a processing aid 

for battery separator manufacturing 

must be limited to lead acid or lithium 

battery separator manufacturing. 

(ii) The owner or operator of the 

location where such use occurs, and 

manufacturers (including importers) 

and processors of TCE for such use, 

must comply with the Workplace 

Chemical Protection Program provisions 

in § 751.311. 

(iii) The owner or operator of the 

location where such use of TCE occurs 

must comply with the recordkeeping 

requirements in § 751.315. 

(2) Certain industrial and commercial 

uses of TCE for DoD naval vessels and 

their systems, and in the maintenance, 

fabrication, and sustainment for and of 

such vessels and systems until [DATE 

10 YEARS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE IN 

THE FEDERAL REGISTER]. The 

following are specific conditions of the 

exemption for industrial and 

commercial uses of TCE for DoD naval 

vessel and their systems, and in the 

maintenance, fabrication, and 

sustainment for and of such vessels and 

systems: 

(i) The industrial and commercial use 

of TCE must be limited for DoD naval 

vessels and their systems, and in the 

maintenance, fabrication, and 

sustainment for and of such vessels and 

systems; 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 

ordnance 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. 

(ii) The owner or operator of the 

location where such use occurs, and 

manufacturers (including importers) 

and processors of TCE for such use, 

must comply with the Workplace 

Chemical Protection Program provisions 

in § 751.311. 

(iii) The owner or operator of the 

location where such use of TCE occurs 

must comply with the recordkeeping 

requirements in § 751.315. 

(3) Closed-loop vapor degreasing 

necessary for human-rated rocket 

engine cleaning by NASA and its 

contractors until [DATE 7 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER]. The following are specific 

conditions of the exemption for 

industrial and commercial use of TCE as 

a solvent for closed-loop vapor 

degreasing necessary for human-rated 

rocket engine cleaning by NASA and its 

contractors § 751.305(b)(12): 

(i) The use of TCE in industrial and 

commercial as a solvent for closed-loop 

vapor degreasing is limited to the 

closed-loop vapor degreasing necessary 

for human-rated rocket engine cleaning 

by NASA and its contractors. 

(ii) The owner or operator of the 

location where such use occurs, and 

manufacturers (including importers) 

and processors of TCE for such use, 

must comply with the Workplace 

Chemical Protection Program provisions 

in § 751.311. 

(iii) The owner or operator of the 

location where such use of TCE occurs, 

and manufacturers (including 

importers) and processors of TCE for 

such use, must comply with the 

recordkeeping requirements in 

§ 751.315. 

[FR Doc. 2023–23010 Filed 10–30–23; 8:45 am] 

BILLING CODE 6560–50–P 


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