[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Proposed Rules]
[Pages 74712-74794]
[FR Doc No: 2023-23010]

Vol. 88

Tuesday,

No. 209

October 31, 2023

Part III

Environmental Protection Agency

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40 CFR Part 751

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

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

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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.

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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<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of TCE or products containing TCE. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities include:
     Crude Petroleum Extraction (NAICS code 211120);
     Fossil Fuel Electric Power Generation (NAICS code 221112);
     Other Electric Power Generation (NAICS code 221118);
     Broadwoven Fabric Mills (NAICS code 313210);
     Narrow Fabric Mills and Schiffli Machine Embroidery (NAICS
code 313220);
     Nonwoven Fabric Mills (NAICS code 313230);
     Textile and Fabric Finishing Mills (NAICS code 313310);
     Fabric Coating Mills (NAICS code 313320);
     Wood Window and Door Manufacturing (NAICS code 321911);
     Prefabricated Wood Building Manufacturing (NAICS code
321992);
     Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220);
     Petroleum Refineries (NAICS code 324110);
     All Other Petroleum and Coal Products Manufacturing (NAICS
code 324199);
     Petrochemical Manufacturing (NAICS code 325110);
     Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
     Ethyl Alcohol Manufacturing (NAICS code 325193);
     All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
     Plastics Material and Resin Manufacturing (NAICS code
325211);
     Medicinal and Botanical Manufacturing (NAICS code 325411);
     Pharmaceutical Preparation Manufacturing (NAICS code
325412);
     Paint and Coating Manufacturing (NAICS code 325510);
     Adhesive Manufacturing (NAICS code 325520);
     Polish and Other Sanitation Good Manufacturing (NAICS code
325612);
     Photographic Film, Paper, Plate and Chemical Manufacturing
(NAICS code 325992);
     All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
     Polystyrene Foam Product Manufacturing (NAICS code
326140);
     Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS code 326150);
     Tire Manufacturing (except Retreading) (NAICS code
326211);
     Tire Retreading (NAICS code 326212);
     Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220);
     Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291);
     All Other Rubber Product Manufacturing (NAICS code
326299);

     Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110);
     Gypsum Product Manufacturing (NAICS code 327420);
     Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
code 331110);
     Iron and Steel Pipe and Tube Manufacturing from Purchased
Steel (NAICS code 331210);
     Rolled Steel Shape Manufacturing (NAICS code 331221);
     Steel Wire Drawing (NAICS code 331222);
     Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
     Copper Rolling, Drawing, Extruding, and Alloying (NAICS
code.331420);
     Nonferrous Metal (except Copper and Aluminum) Rolling,
Drawing and Extruding (NAICS code 331491);
     Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492);
     Nonferrous Metal Die-Casting Foundries (NAICS code
331523);
     Iron and Steel Forging (NAICS code 332111);
     Nonferrous Forging (NAICS code 332112);
     Custom Roll Forming (NAICS code 332114);
     Powder Metallurgy Part Manufacturing (NAICS code 332117);
     Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119);
     Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215);
     Saw Blade and Handtool Manufacturing (NAICS code 332216);
     Metal Window and Door Manufacturing (NAICS code 332321);
     Sheet Metal Work Manufacturing (NAICS code 332322);
     Ornamental and Architectural Metal Work Manufacturing
(NAICS code 332323);
     Power Boiler and Heat Exchanger Manufacturing (NAICS code
332410);
     Metal Tank (Heavy Gauge) Manufacturing (NAICS code
332420);
     Metal Can Manufacturing (NAICS code 332431);
     Other Metal Container Manufacturing (NAICS code 332439);
     Hardware Manufacturing (NAICS code 332510);
     Spring Manufacturing (NAICS code 332613);
     Other Fabricated Wire Product Manufacturing (NAICS code
332618);
     Machine Shops (NAICS code 332710);
     Precision Turned Product Manufacturing (NAICS code
332721);
     Bolt, Nut, Screw, Rivet and Washer Manufacturing (NAICS
code 332722);
     Metal Heat Treating (NAICS code 332811);
     Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812);
     Electroplating, Plating, Polishing, Anodizing and Coloring
(NAICS code 332813);
     Industrial Valve Manufacturing (NAICS code 332911);
     Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912);
     Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913);
     Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919);
     Ball and Roller Bearing Manufacturing (NAICS code 332991);
     Small Arms Ammunition Manufacturing (NAICS code 332992);
     Ammunition (except Small Arms) Manufacturing (NAICS code
332993);
     Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994);
     Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996);
     All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999);
     Farm Machinery and Equipment Manufacturing (NAICS code
333111);
     Lawn and Garden Tractor and Home Lawn and Garden Equipment
Manufacturing (NAICS code 333112);
     Construction Machinery Manufacturing (NAICS code 333120);
     Mining Machinery and Equipment Manufacturing (NAICS code
333131);
     Oil and Gas Field Machinery and Equipment Manufacturing
(NAICS code 333132);
     Food Product Machinery Manufacturing (NAICS code 333241);
     Semiconductor Machinery Manufacturing (NAICS code 333242);
     Sawmill, Woodworking, and Paper Machinery Manufacturing
(NAICS code 333243);
     Printing Machinery and Equipment Manufacturing (NAICS code
333244);
     Other Industrial Machinery Manufacturing (NAICS code
333249);
     Optical Instrument and Lens Manufacturing (NAICS code
333314);
     Photographic and Photocopying Equipment Manufacturing
(NAICS code 333316);
     Other Commercial and Service Industry Machinery
Manufacturing (NAICS code 333318);
     Industrial and Commercial Fan and Blower and Air
Purification Equipment Manufacturing (NAICS code 333413);
     Heating Equipment (except Warm Air Furnaces) Manufacturing
(NAICS code 333414);
     Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415);
     Industrial Mold Manufacturing (NAICS code 333511);
     Special Die and Tool, Die Set, Jig and Fixture
Manufacturing (NAICS code 333514);
     Cutting Tool and Machine Tool Accessory Manufacturing
(NAICS code 333515);
     Machine Tool Manufacturing (NAICS code 333517);
     Rolling Mill and Other Metalworking Machinery
Manufacturing (NAICS code 333519);
     Turbine and Turbine Generator Set Unit Manufacturing
(NAICS code 333611);
     Speed Changer, Industrial High-Speed Drive and Gear
Manufacturing (NAICS code 333612);
     Mechanical Power Transmission Equipment Manufacturing
(NAICS code 333613);
     Other Engine Equipment Manufacturing (NAICS code 333618);
     Air and Gas Compressor Manufacturing (NAICS code 333912);
     Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914);
     Elevator and Moving Stairway Manufacturing (NAICS code
333921);
     Conveyor and Conveying Equipment Manufacturing (NAICS code
333922);
     Overhead Traveling Crane, Hoist and Monorail System
Manufacturing (NAICS code 333923);
     Industrial Truck, Tractor, Trailer and Stacker Machinery
Manufacturing (NAICS code 333924);
     Power-Driven Hand Tool Manufacturing (NAICS code 333991);
     Welding and Soldering Equipment Manufacturing (NAICS code
333992);
     Packaging Machinery Manufacturing (NAICS code 333993);
     Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994);
     Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995);
     Fluid Power Pump and Motor Manufacturing (NAICS code
333996);
     Scale and Balance Manufacturing (NAICS code 333997);
     All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999);
     Audio and Video Equipment Manufacturing (NAICS code
334310);
     Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing (NAICS code 334416);
     Electronic Connector Manufacturing (NAICS code 334417);

     Printed Circuit Assembly (Electronic Assembly)
Manufacturing (NAICS code 334418);
     Other Electronic Component Manufacturing (NAICS code
334419);
     Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS code 334511);
     Automatic Environmental Control Manufacturing for
Residential, Commercial and Appliance Use (NAICS code 334512);
     Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513);
     Instrument Manufacturing for Measuring and Testing
Electricity and Electrical Signals (NAICS code 334515);
     Electric Lamp Bulb and Part Manufacturing (NAICS code
335110);
     Residential Electric Lighting Fixture Manufacturing (NAICS
code 335121);
     Commercial, Industrial and Institutional Electric Lighting
Fixture Manufacturing (NAICS code 335122);
     Other Lighting Equipment Manufacturing (NAICS code
335129);
     Major Household Appliance Manufacturing (NAICS code
335220);
     Power, Distribution and Specialty Transformer
Manufacturing (NAICS code 335311);
     Motor and Generator Manufacturing (NAICS code 335312);
     Switchgear and Switchboard Apparatus Manufacturing (NAICS
code 335313);
     Relay and Industrial Control Manufacturing (NAICS code
335314);
     Storage Battery Manufacturing (NAICS code 335911);
     Fiber Optic Cable Manufacturing (NAICS code 335921);
     Current-Carrying Wiring Device Manufacturing (NAICS code
335931);
     Carbon and Graphite Product Manufacturing (NAICS code
335991);
     Automobile Manufacturing (NAICS code 336111);
     Light Truck and Utility Vehicle Manufacturing (NAICS code
336112);
     Heavy Duty Truck Manufacturing (NAICS code 336120);
     Motor Vehicle Body Manufacturing (NAICS code 336211);
     Truck Trailer Manufacturing (NAICS code 336212);
     Motor Home Manufacturing (NAICS code 336213);
     Travel Trailer and Camper Manufacturing (NAICS code
336214);
     Motor Vehicle Gasoline Engine and Engine Parts
Manufacturing (NAICS code 336310);
     Motor Vehicle Electrical and Electronic Equipment
Manufacturing (NAICS code 336320);
     Motor Vehicle Steering and Suspension Components (except
Spring) Manufacturing (NAICS code 336330);
     Motor Vehicle Brake System Manufacturing (NAICS code
336340);
     Motor Vehicle Transmission and Power Train Parts
Manufacturing (NAICS code 336350);
     Motor Vehicle Seating and Interior Trim Manufacturing
(NAICS code 336360);
     Motor Vehicle Metal Stamping (NAICS code 336370);
     Other Motor Vehicle Parts Manufacturing (NAICS code
336390);
     Aircraft Manufacturing (NAICS code 336411);
     Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412);
     Other Aircraft Part and Auxiliary Equipment Manufacturing
(NAICS code 336413);
     Guided Missile and Space Vehicle Manufacturing (NAICS code
336414);
     Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415);
     Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419);
     Railroad Rolling Stock Manufacturing (NAICS code 336510);
     Ship Building and Repairing (NAICS code 336611);
     Boat Building (NAICS code 336612);
     Motorcycle, Bicycle and Parts Manufacturing (NAICS code
336991);
     Military Armored Vehicle, Tank and Tank Component
Manufacturing (NAICS code 336992);
     All Other Transportation Equipment Manufacturing (NAICS
code 336999);
     Wood Kitchen Cabinet and Counter Top Manufacturing (NAICS
code 337110);
     Upholstered Household Furniture Manufacturing (NAICS code
337121);
     Nonupholstered Wood Household Furniture Manufacturing
(NAICS code 337122);
     Metal Household Furniture Manufacturing (NAICS code
337124);
     Institutional Furniture Manufacturing (NAICS code 337127);
     Wood Office Furniture Manufacturing (NAICS code 337211);
     Surgical Appliance and Supplies Manufacturing (NAICS code
339113);
     Dental Equipment and Supplies Manufacturing (NAICS code
339114);
     Jewelry and Silverware Manufacturing (NAICS code 339910);
     Sporting and Athletic Goods Manufacturing (NAICS code
339920);
     Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991);
     Fastener, Button, Needle and Pin Manufacturing (NAICS code
339993);
     All Other Miscellaneous Manufacturing (NAICS code 339999);
     Metal Service Centers and Other Metal Merchant Wholesalers
(NAICS code 423510);
     Industrial Supplies Merchant Wholesalers (NAICS code
423510);
     Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690);
     Paint, Varnish, and Supplies Merchant Wholesalers (NAICS
code 424950);
     New Car Dealers (NAICS code 441110);
     Used Car Dealers (NAICS code 441120);
     Sporting Goods Stores (NAICS code 451110);
     Scheduled Passenger Air Transportation (NAICS code
481111);
     Other Support Activities for Air Transportation (NAICS
code 481111);
     Other Warehousing and Storage (NAICS code 493190);
     Motion Picture and Video Production (NAICS code 512110);
     Other Financial Vehicles (NAICS code 525990);
     Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715);
     Research and Development in the Social Sciences and
Humanities (NAICS code 541720);
     Offices of Other Holding Companies (NAICS code 551112);
     Carpet and Upholstery Cleaning Services (NAICS code
561740);
     Hazardous Waste Treatment and Disposal (NAICS code
562211);
     Solid Waste Landfill (NAICS code 562212);
     Materials Recovery Facilities (NAICS code 562920);
     Junior Colleges (NAICS code 611210);
     Colleges, Universities and Professional Schools (NAICS
code 611310);
     General Automotive Repair (NAICS code 811111);
     Automotive Exhaust System Repair (NAICS code 811112);
     Automotive Transmission Repair (NAICS code 811113);
     Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118);
     Automotive Body, Paint and Interior Repair and Maintenance
(NAICS code 811121);
     Automotive Glass Replacement Shops (NAICS code 811122);
     Automotive Oil Change and Lubrication Shops (NAICS code
811191);

     All Other Automotive Repair and Maintenance (NAICS code
811198);
     Consumer Electronics Repair and Maintenance (NAICS code
811211);
     Computer and Office Machine Repair and Maintenance (NAICS
code 811212);
     Communication Equipment Repair and Maintenance (NAICS code
811213);
     Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219);
     Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
     Home and Garden Equipment Repair and Maintenance (NAICS
code 811411);
     Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490);
     Coin-Operated Laundries and Drycleaners (NAICS code
812310);
     Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320); and
     Industrial Launderers (NAICS code 812332).
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127; see also 19 CFR 127.28. Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
    If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.

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

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

C. What action is the Agency taking?

    Pursuant to TSCA section 6(b), EPA determined that TCE presents an
unreasonable risk of injury to health, without consideration of costs
or other nonrisk factors, including an unreasonable risk to potentially
exposed or susceptible subpopulations (PESS) identified as relevant to
the 2020 Risk Evaluation for TCE by EPA, under the conditions of use
(Refs. 1, 2). The term ``conditions of use'' is defined at TSCA section
3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
A detailed description of the conditions of use that EPA evaluated in
reaching its determination that TCE presents an unreasonable risk is
included in Unit III.B.1. EPA notes that all TSCA conditions of use of
TCE are subject to this proposal. Accordingly, to address the
unreasonable risk, EPA is proposing, under TSCA section 6(a), to:
    (i) Prohibit the manufacture (including import), processing, and
distribution in commerce of TCE for all uses (including all consumer
uses (see Unit III.B.1.f)), as described in Unit V.A.1., with longer
compliance timeframes for manufacture and processing related to certain
uses;
    (ii) Prohibit the industrial and commercial use of TCE, as
described in Unit V.A.1., with longer compliance timeframes for certain
uses;
    (iii) Prohibit the manufacture (including import) and processing of
TCE as an intermediate for the manufacturing of hydrofluorocarbon134a
(HFC-134a), following an 8.5-year phaseout, as described in Unit
V.A.1.d.;
    (iv) Prohibit the industrial and commercial use of TCE as a solvent
for closed-loop batch vapor degreasing for rayon fabric scouring for
end use in rocket booster nozzle production by Federal agencies and
their contractors, following a 10-year phaseout, outlined in Unit
V.A.1.e.;
    (iv) For Department of Defense (DoD) naval vessels and their
systems, and in the maintenance, fabrication, and sustainment for and
of such vessels and systems, prohibit the industrial and commercial use
of TCE as potting compounds for naval electronic systems and equipment;
sealing compounds for high and ultra-high vacuum systems; bonding
compounds for materials testing and maintenance of underwater systems
and bonding of nonmetallic materials; and cleaning requirements (which
includes degreasing using wipes, sprays, solvents and vapor degreasing)
for: materials and components required for military ordinance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes, following a 10-year TSCA section 6(g) exemption, outlined in
Unit V.A.3.;
    (v) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of TCE as a processing aid for
battery separator manufacturing, following a 10-year TSCA section 6(g)
exemption, as described in Unit V.A.3.;
    (vi) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of TCE as a laboratory chemical for
essential laboratory activities and some research and development
activities, following a 50-year TSCA section 6(g) exemption, as
described in Unit V. A.3.;
    (vii) Prohibit the manufacture (including import), processing,
distribution in commerce, and industrial and commercial use of TCE as a
solvent in closed loop vapor degreasing necessary for human-rated
rocket engine cleaning by the National Aeronautics and Space
Administration (NASA) and its contractors, following a 7-year TSCA
section 6(g) exemption, as described in Unit V.A.3.;
    (viii) Prohibit the emergency industrial and commercial use of TCE
in furtherance of the NASA mission for specific conditions that are
critical or essential and for which no technically and economically
feasible safer alternative is available, following a 10-year TSCA
section 6(g) exemption, as described in Unit V.A.3.;
    (ix) Require strict workplace controls, including compliance with a
TCE workplace chemical protection program (WCPP), which would include
requirements for an inhalation exposure limit and dermal protection to
limit exposure to TCE, for conditions of use with long term phaseouts
or time-

limited exemptions under TSCA section 6(g), as described in Unit
V.A.2.;
    (x) Prohibit, due to worker risks, the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works, with a 50-year TSCA section 6(g) exemption for cleanup
projects, as described in Unit V.A.3.; and
    (xi) Establish recordkeeping and downstream notification
requirements, as described in Unit V.A.4.
    In addition, EPA is proposing to amend the general provisions of 40
CFR part 751, subpart A, to define the following terms so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751: ``authorized
person,'' ``ECEL,'' ``exposure group,'' ``owner or operator,''
``potentially exposed person,'' ``regulated area,'' and ``retailer.''
    EPA seeks public comment on all aspects of this proposed rule.

D. Why is the Agency taking this action?

    Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' TCE was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in January 2023 (Ref.
2), determining that TCE, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. As a
result, EPA is proposing to take action to the extent necessary so that
TCE no longer presents such risk. The unreasonable risk is described in
Unit III.B.2. and the conditions of use EPA evaluated in reaching its
conclusion that TCE presents unreasonable risk are described in Unit
III.B.1.
    TCE's hazards are well established. EPA's 2020 Risk Evaluation for
TCE considered the hazards associated with exposure to TCE and
determined that TCE presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to TCE. While some of the risks of adverse effects from TCE exposure
are experienced following acute single exposures, other risks are
incurred following long-term repeated exposures. Risk of non-cancer
effects, specifically fetal cardiac defects and autoimmunity following
chronic exposure, are the most sensitive adverse effects. In addition,
risks of other significant adverse outcomes associated with TCE
exposure include: Non-cancer effects (liver toxicity, kidney toxicity,
neurotoxicity, immunosuppression, reproductive toxicity, and
developmental toxicity), as well as cancer effects (liver, kidney, and
non-Hodgkin lymphoma). EPA is proposing requirements so that TCE would
no longer present unreasonable risk to human health.
    While EPA's proposal would ultimately result in a complete ban on
TCE, the Agency recognizes that a phaseout of TCE for some TSCA
conditions of use may be appropriate. The timeframes for the phaseouts
differ across conditions of use and are described in fuller detail in
Unit V.A.1.d. and e. One phaseout is for uses that may impact the
Agency's efforts to address climate-damaging HFCs (and the associated
adverse impacts on human health and the environment) under the American
Innovation and Manufacturing Act of 2020 (AIM Act) (42 U.S.C. 7675).
EPA proposes to implement a longer phaseout in tandem with strict
workplace controls for the manufacturing (including import) and
processing of TCE as an intermediate in the generation of HFC-134a, one
of the regulated substances subject to a phasedown under the AIM Act
(More information on HFC-134a is in Unit V.A.1.). While HFC-134a is one
of the regulated substances subject to AIM Act 85% phasedown in
generation and consumption by 2023, HFC-134a can be mixed with other
substances to make lower global warming potential (GWP) blends that are
likely to be used to facilitate the transition from certain other HFCs
and HFC blends with higher global warming potentials in certain
applications.
    Additionally, the Agency recognizes that some conditions of use may
not have alternatives readily available. As an example, EPA is
proposing a longer phaseout timeframe for industrial and commercial use
as a solvent for closed-loop batch vapor degreasing for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, in addition to the uses of TCE
necessary for DoD vessels. Currently, substitutes and alternative
processes do not meet the technical specifications required to clean
the rayon fabric in order to safely produce rockets.
    Additionally, EPA recognizes that some conditions of use may be
important for national security applications or for other critical
needs. For these reasons, EPA's proposal includes a 10-year exemption
under TSCA section 6(g) for industrial and commercial use of TCE as a
processing aid for battery separator manufacturing in the production of
lead-acid and lithium battery separators, as well as for the
manufacturing, processing, and distribution in commerce of TCE for this
use (See Unit V.A.3.a.i.). EPA recognizes that lead-acid and lithium
battery separators are essential components of batteries that power
vehicles and systems in the U.S. supply chain for multiple critical
infrastructure sectors within the national economy. Further, there are
a number of critical uses required for DoD vessels. EPA is proposing a
10-year exemption under TSCA section 6(g) for DoD vessel requirements
for potting, bonding and sealing compounds, and bonding and cleaning
requirements for naval combat systems, radars, sensors, equipment, and
fabrication and prototyping processes. Additionally, EPA is proposing a
50-year exemption under TSCA section 6(g) for the industrial and
commercial use of TCE in laboratory use for essential laboratory
activities which are particularly critical; for example, laboratory
activities associated with ongoing environmental cleanup projects that
fall under the Superfund program or other similar EPA authorities, in
which it is necessary to use TCE as a laboratory chemical for the
analysis of contaminated soil, air, and water samples (See Unit
V.A.3.a.iii.).
    EPA considered the potential impact of the prohibition of the total
production volume of TCE regulated under TSCA on the availability of
TCE for critical or essential uses, for uses essential to the national
economy, national security, or critical infrastructure, and for uses
for which longer phase-out timeframes are proposed. EPA concluded,
based on information received through stakeholder engagement and
professional judgment, that there would remain a sufficient supply of
TCE in circulation for these uses. EPA requests comment on whether
there would remain a sufficient supply of TCE in circulation to provide
a source for those limited critical or essential uses exempted under
TSCA section 6(g), as described in Unit V. (Ref. 3).

E. What are the estimated incremental impacts of this action?

    EPA has prepared an Economic Analysis of the potential incremental

impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 3). As described in more detail in the Economic
Analysis (Ref. 3) and in Units VII.D. and XI.D., EPA was unable to
quantify all incremental costs of this proposed rule. The quantifiable
cost of the proposed rule is estimated to be $33.1 million annualized
over 20 years at a 3% discount rate and $40.6 million annualized over
20 years at a 7% discount rate. These costs take compliance with
implementation of a WCPP into consideration, which would include an
existing chemical exposure limit (ECEL) of 0.0011 ppm (1.1 ppb; 0.0059
mg/m\3\) for inhalation exposures as an 8-hour time-weighted average
(TWA), applicable personal protective equipment (PPE) requirements, and
reformulation costs of numerous products. There are a number of notable
unquantified costs. These are described in this Unit and more fully in
section 7.11 of the Economic Analysis (Ref. 3).
    Alternative products with similar cost and efficacy are available
for most of the products that are formulated with TCE. However, for
some applications, there may be additional unquantified costs
associated with the alternatives or in cases where alternatives are not
currently available. For instance, in some cases, some effort might be
required by firms using TCE products to identify suitable alternatives,
test them for their desired applications, learn how to use them safely
and effectively, and implement new processes for using the alternative
products. There may also be some safety-critical applications where
alternatives would need to undergo extensive safety reviews and testing
before they could replace the TCE products. The information to estimate
how often these costs might be incurred or what the specific costs
would be per-user or per-firm when they are incurred is not available.
Therefore, EPA is unable to consider these costs quantitatively.
    There also may be some unquantified costs associated with the
implementation of a WCPP. EPA estimated a distribution for air
monitoring results but since these data were not collected in the same
way monitoring data under a WCPP would be collected, these estimated
distributions are uncertain and therefore, the costs of the WCPP are
uncertain. The WCPP costs also assume that when the exposure levels
exceed the ECEL, compliance is achieved by implementing a respirator
PPE program. However, the options require that feasible engineering and
administrative controls are implemented before resorting to PPE use.
These costs would be specific to individual firms, and EPA does not
have sufficient information to estimate these costs.
    The costs of alternative identification, testing, and potential
process changes to battery separator manufacturers could not be
estimated. And, if battery separator manufacturers are unable to
transition to TCE-free production processes within the 10-year
timeframe, there could be battery separator supply chain disruptions.
According to one battery separator manufacturer submitting an exemption
request to EPA, 80% of lead-acid and lithium-ion batteries are built
using battery separators manufactured with TCE. According to the
Battery Council International, the U.S. lead-acid battery industry
provides $13.7 billion in gross domestic product. Both battery
separator manufacturers submitting exemption requests noted that there
was only one domestic battery separator manufacturer that does not use
TCE for each of lead-acid and lithium batteries, and they asserted that
the manufacturers would not have sufficient capacity to meet domestic
battery separator demand on their own and could likely support less
than half of the U.S. battery production need. In addition, they also
noted that the domestic battery separator manufacturer that does not
use TCE for lithium batteries uses a ``dry process'' instead of a ``wet
process'', and the ``dry process'' does not allow for reliable
manufacture of the 9-12 [mu]m separators that are generally used for
electric vehicle applications. However, the magnitude of economic
impacts from a potential supply chain disruption is uncertain,
particularly since EPA could take subsequent regulatory action to
extend, modify, or eliminate the exemption on the basis of reasonably
available information and adequate public justification.
    EPA expects the processing of TCE as an intermediate for the
manufacture of HFC-134a to decline over time, in light of the AIM Act
requirements (Ref. 4). At some point, the domestic manufacture of HFC-
134a may be discontinued. While the timing for this discontinuation is
uncertain, it is unclear whether the proposed rule would hasten the
closure of plants that use TCE to produce HFC-134a. There would be some
unknown cost impacts associated with hastening the closure of these two
plants.
    Costs to both fluoroelastomer producers using TCE and those using
TCE as an intermediate to manufacture hydrochloric acid (HCl) may
include potential supply chain disruptions, which could not be
estimated. It is expected that these facilities would need to adopt
process and/or physical plant changes in order to comply with the
proposed rule. EPA does not have sufficient information to estimate the
costs of the prohibition to these sectors.
    Additionally, EPA is proposing a 10-year phaseout for the
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production by Federal agencies and their contractors,
conditioned on Federal agencies performing within 5 years a final pre-
launch test of rocket booster nozzles that have been produced without
using TCE. EPA does not have information to estimate the cost of such a
test. The disposal of TCE from cleanup projects to industrial pre-
treatment, industrial treatment, or publicly owned treatment work would
be prohibited after the section 6(g) exemption ends, 50 years after the
rule is finalized. Cleanup sites would need to identify and implement
alternative disposal or treatment methods, and would likely also need
to renegotiate RCRA permits or CERCLA agreements to include those
changes. These approaches could be more costly to implement and/or
increase the duration of cleanups allowing any potential environmental
or human health impacts to continue for a longer period of time. The
information to estimate how often these costs might be incurred or what
the specific costs would be per site when they are incurred is not
available. Furthermore, the number of sites affected by this
prohibition is unknown.
    Finally, EPA could not estimate any potential business closures or
off-shoring of businesses that might result from the proposed rule.
Vapor degreasing is one use of TCE where switching to a suitable
alternative may be challenging and where closing or off-shoring may be
a compliance strategy. EPA estimates that 366 facilities still use TCE
in vapor degreasers, a majority of which are small businesses. There is
no standard generally accepted approach for estimating the cost impacts
of a firm closure. Despite information EPA has sought from
stakeholders, including through a Small Business Advocacy Review (SBAR)
Panel, it is still unclear as to the entire impact of a prohibition of
TCE vapor degreasing.
    The actions proposed in this rulemaking are expected to achieve
health benefits for the American public, some of which can be monetized
and others that, while tangible and significant, cannot at present be
monetized. The monetized benefits of this rulemaking are approximately
$18.1 to $21.5 million annualized over 20

years at a 3% discount rate and $8.2 to $10.3 million annualized over
20 years at a 7% discount rate. The monetized benefits only include
liver, kidney, and non-Hodgkin's lymphoma cancers.
    There are a number of non-cancer endpoints associated with exposure
to TCE, including liver toxicity, kidney toxicity, reproductive
effects, neurotoxicity, immunotoxicity effects and fetal cardiac
defects (Ref. 1). There is human evidence for hepatitis accompanying
immune-related generalized skin diseases, jaundice, hepatomegaly,
hepatosplenomegaly, and liver failure in TCE-exposed workers and
changes in the proximal tubules of the kidney following exposure to
TCE, and occupational studies have shown increased levels of kidney
damage (proximal tubules) and end-stage renal disease in TCE-exposed
workers. Evidence exists to associate TCE with reproductive effects.
Most human studies support an association between TCE exposure and
alterations in sperm density and quality, as well as changes in sexual
drive or function and serum endocrine levels. Fewer epidemiological
studies exist linking decreased incidence of fecundability (time-to-
pregnancy) and menstrual cycle disturbances in women with TCE
exposures. Human studies have consistently reported vestibular system-
related symptoms such as headaches, dizziness, and nausea following TCE
exposure. Several newer epidemiological studies have found an
association between TCE exposure and neurodegenerative disorders such
as amyotrophic lateral sclerosis and Parkinson's disease (Ref. 1). EPA
does not have sufficient information to estimate the monetized benefits
of the proposed rule with respect to these non-cancer effects, and
therefore monetized benefits are likely underestimated.
    EPA does estimate that there are 52,595 workers and occupational
non-users (ONUs, or people who do not directly handle the chemical, but
are in close proximity) exposed to TCE and of those, approximately 982
pregnant workers and ONUs annually that may potentially benefit from a
reduced risk of fetal cardiac defects resulting from reduced TCE
exposure. Although EPA has not developed a complete estimate of the
monetized benefits associated with avoiding fetal cardiac defects, as
described in the Economic Analysis (Ref. 3), Arth, Tinker et al. (Ref.
5) estimated a mean annual cost of $41,166 (2013$) (median $14,552) for
each fetal cardiac defects-associated hospitalization. For critical
fetal cardiac defects, mean and median costs were estimated at $79,011
and $29,886 (2013$), respectively for each incidence. In addition to
hospitalization costs, individuals with fetal cardiac defects will
likely incur healthcare costs associated with physician visits and
outpatient care. They are also more likely to require specialized
healthcare such as medications, physical or speech therapy, or
treatment for developmental or behavioral problems (Ref. 6). Additional
social costs may include caregiver burden and mental health services
(Ref. 7), as well as non-market costs such as pain and suffering and
fetal cardiac defect-related mortality. Because these costs are not
accounted for, monetized benefits are likely underestimated. The
severity of specific types of fetal cardiac defects and associated
costs will vary depending on the type of heart defect. EPA requests
comment on information that would allow EPA to quantify the magnitude
of avoided risk of fetal cardiac defects due to reductions in TCE
exposure under the proposed rulemaking.
    Additionally, to the extent that the proposed rule reduces the
amount of TCE in drinking water systems and thereby exposures to
populations using those drinking water sources, there could be
potential health-related benefits related to improved drinking water
quality that EPA was unable to quantify.

II. Background

A. Overview of TCE

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

B. Regulatory Actions Pertaining to TCE

    TCE is subject to numerous Federal laws and regulations in the
United States and is also subject to regulation by some States and
other countries. A summary of EPA regulations pertaining to TCE, as
well as other Federal, State, and international regulations (Ref. 9) is
in the docket and in Appendix A of the 2020 Risk Evaluation for TCE
(Ref. 1).
    C. Consideration of Occupational Safety and Health Administration
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA
Risk Management Actions
    Although EPA must consider and factor in, to the extent
practicable, certain non-risk factors as part of TSCA section 6(a)
rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still
ensure that the selected regulatory requirements apply ``to the extent
necessary so that the chemical substance or mixture no longer presents
[unreasonable] risk.'' This requirement to eliminate unreasonable risk
is distinguishable from approaches mandated by some other laws,
including the Occupational Safety and Health Act (OSH Act), which
includes both significant risk and feasibility (technical and economic)
considerations in the setting of standards.
    Congress intended for EPA to consider occupational risks from
chemicals it evaluates under TSCA, among other potential exposures, as
relevant and appropriate. As noted previously, TSCA section 6(b)
requires EPA to evaluate risks to PESS identified as relevant by the
Administrator. TSCA section 3(12) defines the term ``potentially
exposed or susceptible subpopulation'' as ``a group of individuals
within the general population identified by the Administrator who, due
to either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.''
    The OSH Act similarly requires OSHA to evaluate risk specific to
workers prior to promulgating new or revised standards and requires
OSHA standards to substantially reduce significant risk to the extent
feasible, even if workers are exposed over a full working lifetime. See
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
    Thus, the standards for chemical hazards that OSHA promulgates
under the OSH Act share a broadly similar

purpose with the standards that EPA promulgates under TSCA section
6(a). The control measures OSHA and EPA require to satisfy the
objectives of their respective statutes may also, in many
circumstances, overlap or coincide. However, as this unit outlines,
there are important differences between EPA's and OSHA's regulatory
approaches and jurisdiction, and EPA considers these differences when
deciding whether and how to account for OSHA requirements (Ref. 9) when
evaluating and addressing potential unreasonable risk to workers so
that compliance requirements are clearly explained to the regulated
community.
1. OSHA Requirements
    OSHA's mission is to ensure that employees work in safe and
healthful conditions. The OSH Act establishes requirements that each
employer comply with the General Duty Clause of the Act (29 U.S.C.
654(a)), as well as with occupational safety and health standards
issued under the Act.
a. General Duty Clause of the OSH Act
    The General Duty Clause of the OSH Act requires employers to keep
their workplaces free from recognized hazards that are causing or are
likely to cause death or serious physical harm to employees. The
General Duty Clause is cast in general terms, and does not establish
specific requirements like exposure limits, PPE, or other specific
protective measures that EPA could potentially consider when developing
its risk evaluations or risk management requirements. OSHA, under
limited circumstances, has cited the General Duty Clause for regulating
exposure to chemicals. To prove a violation of the General Duty Clause,
OSHA must prove employer or industry recognition of the hazard, the
hazard was causing or likely to cause death or serious physical harm,
and a feasible method to eliminate or materially reduce the hazard was
available. In rare situations, OSHA has cited employers for violation
of the General Duty Clause where exposures were below a chemical-
specific permissible exposure limit (PEL), a TWA based on an employee's
average airborne exposure in any 8-hour work shift of a 40-hour work
week which shall not be exceeded (Ref. 10). In such situations, OSHA
must demonstrate that the employer had actual knowledge that the PEL
was inadequate to protect its employees from death or serious physical
harm. Because of the heavy evidentiary burden on OSHA to establish
violations of the General Duty Clause, it is not frequently used to
cite employers for employee exposure to chemical hazards.
b. OSHA Standards
    OSHA standards are issued pursuant to the OSH Act and are found in
title 29 of the CFR. There are separate standards for general industry,
laboratories, construction, maritime and agriculture sectors, and
general standards applicable to a number of sectors (e.g., OSHA's
Respiratory Protection standard). OSHA has numerous standards that
apply to employers who operate chemical manufacturing and processing
facilities, as well as to downstream employers whose employees may be
occupationally exposed to hazardous chemicals.
    OSHA sets legally enforceable limits on the airborne concentrations
of hazardous chemicals, referred to as PELs, established for employers
to protect their workers against the health effects of exposure to
hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart
Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act,
OSHA was permitted an initial 2-year window after the passage of the
Act to adopt ``any national consensus standard and any established
Federal standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971
to establish PELs that were adopted from Federal health standards
originally set by the Department of Labor through the Walsh-Healy Act,
in which approximately 400 occupational exposure limits (OELs) were
selected based on the American Conference of Governmental Industrial
Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In
addition, about 25 exposure limits recommended by the American
Standards Association (now called the American National Standards
Institute or ANSI) were adopted as PELs.
    Following the 2-year window provided under section 6(a) of the OSH
Act for adoption of national consensus and existing Federal standards,
OSHA has issued health standards following the requirements in section
6(b) of the Act. OSHA has established approximately 30 PELs under
section 6(b)(5) as part of comprehensive substance-specific standards
that include additional requirements for protective measures such as
use of PPE, establishment of regulated areas, exposure assessment,
hygiene facilities, medical surveillance, and training. These ancillary
provisions in substance-specific OSHA standards further mitigate
residual risk that could be present due to exposure at the PEL.
    Many OSHA PELs have not been updated since they were established in
1971, including the PEL for TCE. In many instances, scientific evidence
has accumulated suggesting that the current limits of many PELs are not
sufficiently protective. On October 10, 2014, OSHA published a Federal
Register document in which it recognized that many of its PELs are
outdated and inadequate for ensuring protection of worker health (79 FR
61384). In addition, health standards issued under section 6(b)(5) of
the OSH Act must reduce significant risk only to the extent that it is
technologically and economically feasible. OSHA's legal requirement to
demonstrate that its section 6(b)(5) standards are technologically and
economically feasible at the time they are promulgated often precludes
OSHA from imposing exposure control requirements sufficient to ensure
that the chemical substance no longer presents a significant risk to
workers. As described in that document, while new advancements or
developments in science and technology from the time a PEL is
promulgated may improve the scientific basis for making findings of
significant risk, technical feasibility or economic feasibility, OSHA
has been unable to update most of the PELs established in 1971 and they
remain at levels at which they were initially adopted (79 FR 61384,
October 10, 2014). One example of how industries have evolved in the
intervening 50 years as to what is technologically and economically
feasible is the halogenated solvent cleaning industry, which, in
response to EPA's National Emission Standards for Hazardous Air
Pollutants (NESHAP) promulgated under section 112 of the 1990 Clean Air
Act Amendments (see National Emissions Standards for Halogenated
Solvent Cleaning, 40 CFR part 63, subpart T), has made equipment
improvements that conserve solvent resources and reduce workplace
exposure.
    In sum, the great majority of OSHA's chemical standards are
outdated or do not sufficiently reduce risk to workers. While it is
possible in some cases that the OSHA standards for some chemicals
reviewed under TSCA will eliminate unreasonable risk, based on EPA's
experience thus far in conducting occupational risk assessments under
TSCA, EPA believes that OSHA chemical standards would in general be
unlikely to address unreasonable risk to workers within the meaning of
TSCA, since TSCA section 6(b) unreasonable risk determinations may
account for unreasonable risk to more sensitive endpoints (derived from
scientific

studies that had not yet been conducted at the time OSHA promulgated
its standards) and working populations than OSHA's risk evaluations
typically contemplate, and EPA is obligated to apply TSCA section 6(a)
risk management requirements to the extent necessary so that the
unreasonable risk is no longer presented.
    Because the requirements and application of TSCA and OSHA
regulatory analyses differ, and because OSHA's chemical-specific
standards are decades old and may include outdated assumptions
regarding the most sensitive end-point and/or the technological and
economic feasibility of the standards, it is necessary for EPA to
conduct risk evaluations and, where it finds unreasonable risk to
workers, develop risk management requirements for chemical substances
that OSHA also regulates, and it is expected that EPA's findings and
requirements may sometimes diverge from OSHA's. However, it is also
appropriate that EPA consider the chemical standards that OSHA has
already developed to limit the compliance burden to employers by
aligning management approaches required by the agencies, where
alignment will adequately address unreasonable risk to workers. Unit
II.C.2. discusses EPA's consideration of OSHA standards in its risk
evaluation and management strategies under TSCA.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
    When characterizing the risk during risk evaluation under TSCA, EPA
believes it is appropriate to evaluate the levels of risk present in
scenarios where no mitigation measures are assumed to be in place for
the purpose of determining unreasonable risk (see Unit II.C.2.a.).
However, the Agency acknowledges that, in some cases, mitigation
measures are already in place. It should be noted that there are some
cases where scenarios may reflect certain mitigation measures, such as
(e.g., in instances where exposure estimates are based on monitoring
data at facilities that have existing engineering controls in place).
For example, the Halogenated Solvent Cleaning NESHAP, first promulgated
in 1994 and last updated in 2007, established standards reflecting the
maximum achievable control technology for major and certain area
sources, standards reflecting generally available control technology
for other area sources, and facility-wide emission limits for certain
halogenated solvent cleaning machines. Consequently, emissions
monitoring from facilities meeting the NESHAP would reflect emissions
reduction resulting from existing engineering controls already in place
to meet the standards.
    In addition, EPA believes it may be appropriate to also evaluate
the levels of risk present in scenarios considering applicable OSHA
requirements as well as scenarios considering industry or sector best
practices for industrial hygiene that are clearly articulated to the
Agency. EPA may evaluate risk under scenarios that consider industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency, when doing so serves to inform its risk
management efforts. Characterizing risks using scenarios that reflect
different levels of mitigation can help inform potential risk
management actions by providing information that could be used during
risk management to tailor risk mitigation appropriately to address any
unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).
a. Risk Characterization for Unreasonable Risk Determination
    When making unreasonable risk determinations as part of TSCA risk
evaluations, EPA cannot assume as a general matter that all workers are
always equipped with and appropriately using sufficient PPE, although
EPA does not question the veracity of public comments received on the
2020 Risk Evaluation for TCE regarding the occupational safety
practices often followed by industry respondents. When characterizing
the risk to human health from occupational exposures during risk
evaluation under TSCA, EPA believes it is appropriate to evaluate the
levels of risk present in scenarios where PPE is not assumed to be used
by workers. This approach of not assuming PPE use by workers considers
the risk to PESS (workers and occupational non-users (ONUs)) who may
not be covered by OSHA standards, such as self-employed individuals and
public sector workers who are not covered by a State Plan. Mitigation
scenarios included in the EPA risk evaluation (e.g., scenarios
considering use of PPE) likely represent current practice in many
facilities where companies effectively address worker and bystander
safety requirements. However, the Agency cannot assume that all
facilities across all uses of the chemical substance will have adopted
these practices for the purposes of making the TSCA risk determination.
    Therefore, EPA makes its determinations of unreasonable risk based
on scenarios that do not assume compliance with OSHA standards,
including any applicable exposure limits or requirements for use of
respiratory protection or other PPE. Making unreasonable risk
determinations based on such scenarios should not be viewed as an
indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread
noncompliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that unreasonable risk may exist for subpopulations of
workers that may be highly exposed because they are not covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by an OSHA State Plan, or because their employer is
out of compliance with OSHA standards, or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding existing OSHA
requirements.
b. Risk Evaluation To Inform Risk Management Requirements
    In addition to the scenarios described previously, EPA risk
evaluations may characterize the levels of risk present in scenarios
considering applicable OSHA requirements (e.g., chemical-specific PELs
and/or chemical-specific health standards with PELs and additional
ancillary provisions) as well as scenarios considering industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency to help inform risk management decisions.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
    When undertaking risk management actions, EPA: (1) Develops
occupational risk mitigation measures to address any unreasonable risk
identified by EPA, striving for compatibility with applicable OSHA
requirements and industry best practices, including appropriate
application of the hierarchy of controls, when those measures would
address an unreasonable risk; and (2) Ensures that EPA requirements
apply to all potentially exposed workers in accordance with TSCA
requirements. Consistent with TSCA section 9(d), EPA consults and
coordinates TSCA activities with OSHA and other relevant Federal
agencies for the purpose of achieving the maximum applicability of TSCA
while avoiding the imposition of duplicative requirements.
    Informed by the mitigation scenarios and information gathered
during the risk evaluation and risk management process, the Agency
might propose rules that require risk management practices that may be
already common practice in many or most facilities. Adopting clear,
broadly applicable regulatory standards will foster compliance across
all

facilities (ensuring a level playing field) and assure protections for
all affected workers, especially in cases where current OSHA standards
may not apply to them or not be sufficient to address the unreasonable
risk.
    For evaluation scenarios which involve OSHA chemical-specific PELs,
EPA's risk evaluation in some cases may illustrate that limiting
exposure to OSHA's PEL would result in acceptable levels of risk under
TSCA under certain conditions of use. In these cases, TSCA risk
management requirements could incorporate and reinforce requirements in
OSHA standards and ensure that risks are addressed, including for
circumstances where OSHA requirements are not applicable (e.g., public
sector workers not covered by an OSHA State plan, and self-employed
workers) by asserting TSCA compliance/enforcement as well. EPA's risk
evaluation may also find unreasonable risk under TSCA associated with
some occupational conditions of use (see Unit III.B.1.f.), even when
the applicable OSHA requirements are being met. In these cases, EPA
would need to develop risk management requirements beyond those
included in OSHA's standards.
4. TCE and OSHA Requirements
    EPA incorporated the considerations described in Unit II.C. into
the 2020 Risk Evaluation for TCE, the January 2023 revised unreasonable
risk determination for TCE, and this rulemaking. Specifically, in the
TSCA 2020 Risk Evaluation for TCE, EPA presented risk estimates based
on workers' exposures with and without respiratory protection. EPA
determined that even when respirators are used by workers, most of the
conditions of use evaluated drove the unreasonable risk. Additional
consideration of OSHA standards in the revised unreasonable risk
determination is discussed further in the Federal Register document
announcing that document (Ref. 11). In Unit III.B.3. and Unit
V.A.2.b.iii., EPA outlines the importance of considering the hierarchy
of controls used by the industrial hygiene community (hereafter
referred to as ``hierarchy of controls'') when developing risk
management actions in general, and specifically when determining if and
how regulated entities may meet a risk-based exposure limit for TCE.
The hierarchy of controls is a prioritization of exposure control
strategies from most preferred to least preferred techniques. The
control strategies include elimination of the hazard, substitution with
a less hazardous substance, engineering controls, administrative
controls such as training or exclusion zones with warning signs, and,
finally, use of PPE (Ref. 12). Under the hierarchy of controls, the use
of respirators and dermal PPE should only be considered after all other
steps have been taken to reduce exposures. As discussed in Units V.A.
and VI.A.1., EPA's risk management approach would not rely solely or
primarily on the use of respirators and dermal PPE to address
unreasonable risk to workers; instead, EPA is proposing prohibitions
for all conditions of use, with a WCPP for certain occupational
conditions of use before the prohibitions are fully implemented. The
WCPP would require consideration of the hierarchy of controls before
use of respirators and other PPE. The WCPP is discussed in full in
Units V.A.2. and VI.A.1.b.
    In accordance with the approach described in Unit II.C.3., EPA
intends for this regulation to be as compatible as possible with the
existing OSHA standards, with additional requirements as necessary to
address the unreasonable risk. One notable difference between the WCPP
and the OSHA standards are the exposure limits. The WCPP would include
an ECEL of either 0.0011 ppm (1.1 ppb) or 0.0040 ppm (4.0 ppb) as an 8-
hour TWA; exposures at or below each ECEL would not result in
unreasonable risk for chronic cancer and non-cancer and acute non-
cancer inhalation endpoints (See Unit IV.A. for further discussion
about an ECEL of 0.0011 ppm and Unit IV.B. for further discussion about
an ECEL of 0.0040 ppm. Refer to Unit VI.A. for discussion about why EPA
is considering two TCE ECELs and EPA's related request for public
comment). EPA recognizes that for TCE, either ECEL would be
significantly lower than the OSHA PEL (100 ppm as an 8-hour TWA). In
addition to the distinctions in statutory requirements described in
this unit, EPA has identified several factors contributing to the
differences in these levels, outlined here.
    The TSCA ECEL value for TCE is a lower value than the OSHA PEL (and
other existing OELs, discussed in Unit II.C.5.) for many reasons,
including that the PEL, established in 1971, may not fully capture
either the complete database of studies considered in the 2020 Risk
Evaluation for TCE or more recent advances in modeling and scientific
interpretation of toxicological data applied in the calculation of the
TCE ECEL. The proposed numeric ECEL values considered for incorporation
into the WCPP are derived from the analysis in the 2020 Risk Evaluation
for TCE, which EPA considers to represent the best available science
under TSCA section 26(h) because it was subject to peer review and is
the result of a systematic review process that considered reasonably
available information in order to identify relevant adverse health
effects. Additionally, by using the information from the 2020 Risk
Evaluation for TCE, the ECEL incorporates advanced modeling and peer-
reviewed methodologies, and accounts for exposures to potentially
exposed and susceptible subpopulations, as required by TSCA.
    For TCE, the EPA ECEL is an 8-hour occupational inhalation exposure
limit, and it takes into consideration the uncertainties identified in
the 2020 Risk Evaluation for TCE. For TCE, EPA derived two distinct
ECEL values.
    The ECEL of 0.0011 ppm is based on the most sensitive overall human
health endpoint of developmental toxicity, specifically, fetal cardiac
defects based on rat data from Johnson et al., 2003 (Refs. 1, 13). It
represents the concentration at which an individual, including a member
of a PESS, especially older pregnant workers and ONUs (the group
identified as most susceptible to cardiac defects in their developing
fetus based on epidemiological data), would be unlikely to suffer
adverse effects if exposed for a single 8-hr workday. This value is
also protective of health effects that could present following chronic
or lifetime exposures under typical occupational exposure scenarios.
The ECEL of 0.0011 ppm incorporates a benchmark margin of exposure of
10 to account for inter- and intra-species toxicodynamic variability.
In addition to the ECEL, as part of this rulemaking, EPA is proposing
an ECEL action level, which is a value equal to half of the ECEL, that
would trigger additional monitoring to ensure that workers are not
exposed to concentrations above the ECEL. Exposure monitoring and
establishing a baseline of TCE exposure for potentially exposed
persons, as well as identifying the lowest achievable exposure level in
a facility, is further discussed in Unit V.A.2.
    The ECEL of 0.0040 ppm is based on chronic autoimmunity,
representing the most protective exposure limit from the best overall
acute and chronic non-cancer endpoints under TSCA of immunosuppression
and autoimmunity, respectively (Refs. 14, 46, 1). The ECEL of 0.0040
ppm is based on elevated anti-double stranded DNA (anti-dsDNA) and
single-stranded DNA (ssDNA) antibodies following chronic exposure based
on mouse data from Keil et al, 2009 (Ref. 1). The ECEL based on
autoimmunity was derived from the PBPK model-adjusted assumptions of 8-

hour daily exposure and elevated respiratory rate for workers, and it
incorporates a benchmark MOE of 30 to account for inter- and intra-
species toxicodynamic variability as well as the absence of a no-effect
level in the study (Ref. 1).
    The OSHA PEL for TCE of 100 ppm as an 8-hour TWA was established in
1971. OSHA is required to promulgate a standard that reduces
significant risk to the extent that it is technologically and
economically feasible to do so (81 FR 16285) at the time of
promulgation. As part of a 1989 air contaminants standard for 428 toxic
substances, OSHA lowered the PEL to 50 ppm based on a quantitative
cancer risk assessment and technological feasibility analysis (See 54
FR 2332, 2432(1989)). This rulemaking was later vacated by court order,
which held that OSHA failed to establish that: (1) the existing PELs
presented a significant risk of material health impairment; (2) the new
standards eliminated or substantially lessened the risk; and (3) the
new PELs were economically or technologically feasible (Ref. 15). As a
result, the PEL for TCE reverted to the original PEL of 100 ppm. The
basis of the 100 ppm PEL is unclear; however, most original PELs were
based on acute health effects only observable at higher concentrations
and did not take into account more sensitive repeated dose studies,
including the studies used to inform the TCE ECEL, that were not
available at the time the PEL was established (see, e.g., 79 FR 61383,
61388). As discussed in Units II.D., III.B., and VIII.D., the TSCA
ECELs for the TCE WCPP are based on the 2020 Risk Evaluation for TCE
and represent the best available science. As described in Unit II.C.1.,
in a 2014 request for information OSHA described how, while new
developments in science and technology from the time the PEL for TCE
was established in 1971 may improve the scientific basis for making
findings of significant risk, technical feasibility, or economic
feasibility that is required under section 6(b)(5) of the OSH Act, OSHA
has been unable to update the PEL for TCE and it remains at the level
that was originally adopted in 1971 (79 FR 61383, October 10, 2014).
5. TCE and Other Occupational Exposure Limits
    EPA is aware of other OELs for TCE, including the ACGIH TLV, the
California Division of Occupational Safety and Health (Cal/OSHA) PEL,
and the National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL).
    The 8-hour TWA TLV currently recommended by the ACGIH is 10 ppm,
based on a most recent update in 2007. This TLV is based on central
nervous system (CNS) effects occurring at 100 ppm and above (Ref. 16).
Kidney toxicity, cancer, and developmental toxicity were also indicated
at high doses. Overall, the 10 ppm TLV does not seem to be directly
derived from any particular endpoint and can be considered only a semi-
quantitative estimate. The TLV report did not cite either the immune
study used as the basis of EPA's alternative ECEL of 0.0040 ppm (Keil
et al., 2009), nor did it cite Johnson et al., 2003, which is the basis
of EPA's proposed ECEL of 0.0011 ppm. Notably, the most recent TLV
report was released prior to publication of Keil et al., 2009, and the
TLV was not directly derived from any particular endpoint or hazard
value. Among other cited studies that are discussed in the 2020 Risk
Evaluation, the TLV report only discusses LOAELs and did not apply
benchmark dose modeling, PBPK modeling, or any uncertainty factors that
would have contributed to a reduced exposure limit. The report does
identify TCE as a suspected human carcinogen and discusses
epidemiological evidence for several cancers, but there is no
consideration of low-dose linear extrapolation that would have resulted
in a substantially lower TLV.
    The current NIOSH REL is based on the ``lowest feasible level''
standard applied to carcinogens, labeled as ``Ca (potential
occupational carcinogen), minimize exposure concentrations'' (Ref. 17),
as well as a 2 ppm 60-minute ceiling REL value when used as an
anesthetic agent and a 25 ppm 10-hour TWA REL for other exposures. As
described in NIOSH's Appendix A, the non-quantitative value applied to
carcinogens is based on the lowest feasible concentration (Ref. 18).
The 25 ppm TWA was based on concerns for CNS effects at higher doses
and a review of industrial hygiene reports supporting the feasibility
of a 25-ppm limit. Notably, this ceiling limit is from 1990, over a
decade before publication of any of the key studies EPA used for risk
determination or ECEL derivation.
    The 2007 Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and
equivalent to the NIOSH REL TWA (Ref. 19). According to Cal/OSHA, the
origin of the Cal/OSHA PEL is not clear but is assumed to be based on
the NIOSH REL threshold value, which cited CNS effects and liver cancer
in animals (Ref. 20).

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

    In December 2016, EPA selected TCE as one of the first 10 chemicals
for risk evaluation under TSCA section 6 (15 U.S.C. 2605) (81 FR 91927,
December 19, 2016) (FRL-9956-47). EPA published the scope of the TCE
risk evaluation (82 FR 31592, July 7, 2017) (FRL-9963-57), and, after
receiving public comments, published the problem formulation in June
2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In February 2020, EPA
published a draft risk evaluation (85 FR 11079, February 26, 2020)
(FRL-10005-52), and after public comment and peer review by the Science
Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk
Evaluation for TCE in November 2020 in accordance with TSCA section
6(b) (85 FR 75010, November 24, 2020) (FRL-10016-91). EPA subsequently
issued a draft revised TSCA unreasonable risk determination for TCE (87
FR 40520, July 7, 2022) (FRL-9945-01-OCSPP) and after public notice and
receipt of comments, published a final revised Unreasonable Risk
Determination for TCE in January 2023 (88 FR 1222, January 9, 2023)
(FRL-9945-02-OCSPP). The 2020 Risk Evaluation for TCE and supplemental
materials are in docket EPA-HQ-OPPT-2019-0500, with the January 2023
final revised unreasonable risk determination and additional materials
supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0737,
on https://www.regulations.gov.
1. 2020 Risk Evaluation
    In the 2020 Risk Evaluation for TCE, EPA evaluated risks associated
with 54 conditions of use within the following categories: manufacture
(including import), processing, distribution in commerce, industrial
and commercial use, consumer use, and disposal (Ref. 1). Descriptions
of these conditions of use are in Unit III.B.1.
    The 2020 Risk Evaluation for TCE identified significant adverse
health effects associated with short- and long-term exposure to TCE,
including non-cancer effects (immunosuppression and developmental
toxicity) from acute inhalation exposures and dermal exposures, and
non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity,
autoimmunity, reproductive toxicity, and developmental toxicity) and
cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic
inhalation exposures to TCE. A further discussion of the hazards of TCE
is in Unit III.B.2.
    In the 2020 Risk Evaluation for TCE, EPA documented its
unreasonable risk

policy determination for TCE and based it on the immunotoxicity
endpoint rather than the most sensitive endpoint (developmental
toxicity). The 2020 Risk Evaluation for TCE included a robust
scientific description of the developmental toxicity endpoint,
specifically fetal cardiac defects, and the analysis in the risk
evaluation supporting the developmental toxicity endpoint noted that
this endpoint presents lower PODs (Ref. 1). EPA identified the risk of
fetal cardiac defects most strongly associated with offspring of older
mothers, and therefore included risk estimates for fetal cardiac
defects that account for susceptible mothers and their offspring in
addition to PESS groups with other susceptibilities (e.g., diabetes,
infection status, drug exposure, stress, and metabolic sensitivity due
to increased enzymatic activity of cytochrome P450 2E1 (CYP2E1)) (Ref.
1). EPA recognizes that there are differing views about the
appropriateness of EPA's policy decision in 2020 to use the
immunotoxicity endpoint as the basis for EPA's unreasonable risk
determination. EPA also notes that the endpoint selected as the basis
for the TSCA section 6 unreasonable risk determination in the risk
evaluation that is the basis for this proposed rule should not
necessarily be construed as appropriate for or consistent with the
basis for other Agency assessments such as the Integrated Risk
Information System (IRIS) assessment for TCE or for actions taken by
other agency programs. Further, EPA has received numerous comments on
EPA's 2020 TSCA Risk Evaluation policy choice regarding endpoint
selection that have raised concerns pertaining to political
interference and scientific integrity, among other issues. In
recognition of this history, EPA is therefore requesting comment on the
use of the more sensitive developmental toxicity endpoint to inform TCE
risk management decisions. In particular, EPA notes that this proposed
rule for regulating the unreasonable risk of TCE demonstrates that both
the immunotoxicity and developmental toxicity endpoints support the
proposed prohibitions, discussed in detail in Unit IV.
2. Revised Unreasonable Risk Determination
    EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the 2020 Risk Evaluation
for TCE, to ensure that the risk evaluations upon which risk management
decisions are made better align with TSCA's objective of protecting
human health and the environment. For TCE, EPA revised the original
unreasonable risk determination based on the 2020 Risk Evaluation for
TCE and issued a final revised unreasonable risk determination in
January 2023 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for TCE pursuant to TSCA section 6(b) and Executive
Order 13990, (entitled ``Protecting Public Health and the Environment
and Restoring Science to Tackle the Climate Crisis'') and other
Administration priorities (Refs. 21, 22, 23). The revisions consisted
of making the risk determination for the whole chemical substance
rather than for individual conditions of use (which resulted in the
revised risk determination superseding the prior ``no unreasonable
risk'' determinations and withdrawing the associated TSCA section
6(i)(1) ``no unreasonable risk'' order); and clarifying that the risk
determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE. (Ref. 2).
    In determining whether TCE presents unreasonable risk under the
conditions of use, EPA considered relevant risk-related factors,
including, but not limited to: the effects of the chemical substance on
health (including cancer and non-cancer risks) and human exposure to
the substance under the conditions of use (including duration,
magnitude, and frequency of exposure); the effects of the chemical
substance on the environment and environmental exposure under the
conditions of use; the population exposed (including any PESS); the
severity of hazard (including the nature of the hazard, the
irreversibility of the hazard); and uncertainties.
    EPA determined that TCE presents an unreasonable risk of injury to
health. The unreasonable risk determination, based on immunotoxicity
and cancer, is driven by risks to workers and ONUs (workers who do not
directly handle the chemical but perform work in an area where the
chemical is present) due to occupational exposures to TCE (i.e., during
manufacture, processing, industrial and commercial uses, and disposal);
and to consumers and bystanders associated with consumer uses of TCE
due to exposures from consumer use of TCE and TCE-containing products.
Though the revised unreasonable risk determination was based on cancer
and the best overall non-cancer endpoints for use in risk evaluation
under TSCA (immunosuppression effects for acute inhalation and dermal
exposures, and autoimmunity effects for chronic inhalation and dermal
exposures), consistent with the 2020 Risk Evaluation for TCE, the
Agency is proposing to base the risk management requirements for the
WCPP on a more sensitive endpoint to account for particular health
effects identified in the underlying 2020 Risk Evaluation for TCE
relevant to PESS, as discussed in Unit IV.A. and V.A.2.
    EPA did not identify unreasonable risk of injury to the environment
for TCE. The TCE conditions of use that EPA evaluated and whose risk
support EPA's determination that the chemical substance poses
unreasonable risk to health, are listed in the unreasonable risk
determination (Ref. 2) and also in Unit III.B.
3. Fenceline Screening Analysis
    The 2020 Risk Evaluation for TCE excluded the assessment of certain
exposure pathways that were or could be regulated under another EPA-
administered statute (see section 1.4.2 of the November 2020 Risk
Evaluation for TCE (Ref. 1). This resulted in the surface water,
drinking water, and ambient air pathways for TCE exposure not being
assessed for human health risk to the general population. In June 2021,
EPA made a policy announcement on the path forward for TSCA chemical
risk evaluations, indicating that EPA would, among other things,
examine whether the exclusion of certain exposure pathways from the
risk evaluations could lead to a failure to adequately protect
fenceline communities (Ref. 24). EPA then conducted a screening
analysis to identify whether there may be risks to people living near
the fenceline of facilities releasing TCE.
    In order to assess whether there are no risks of concern or whether
there may be risks of concern to the general population in proximity to
a facility releasing TCE, EPA developed the TSCA Screening Level
Approach for Assessing Ambient Air and Water Exposures to Fenceline
Communities Version 1.0, which was presented to the SACC in March 2022,
with a report issued by the SACC on May 18, 2022 (Ref. 25). This
screening level approach, which EPA believes is very effective in
accurately assessing where fenceline exposures are of no concern is
discussed in Unit VII.A.

III. Regulatory Approach

A. Background

    Under TSCA section 6(a), if the Administrator determines, through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance

or mixture, or any combination of such activities, presents an
unreasonable risk of injury to health or the environment, EPA must by
rule apply one or more of the following requirements to the extent
necessary so that the chemical substance or mixture no longer presents
such risk.
     Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (TSCA section
6(a)(1)).
     Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
     Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
     Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
     Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
     Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
     Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
     Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
    As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk, so
that TCE no longer presents such unreasonable risk. EPA's proposed
regulatory action and a primary alternative regulatory action are
described in Unit V. EPA is requesting public comment on all elements
of the proposed regulatory action and the alternative regulatory action
and is providing notice that based on consideration of comments and any
new information submitted to EPA during the comment period on this
proposed rule, EPA may in the final rule modify elements of the
proposed regulatory action. The public should understand that public
comments could result in changes to elements of the proposed and
alternative regulatory actions when this rulemaking is finalized. For
example, elements such as timeframes for phase out could be lengthened
or shortened, ECELs could be modified, or the WCPP could have
conditions added or eliminated.
    Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption from a requirement of a TSCA section 6(a) rule
for a specific condition of use if EPA finds that: (1) The specific
condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; (2) Compliance with the
requirement, as applied with respect to the specific condition of use,
would significantly disrupt the national economy, national security, or
critical infrastructure; or (3) The specific condition of use, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety. Based on
reasonably available information, EPA has analyzed the need for an
exemption and has found that TSCA section 6(g) exemptions are warranted
for certain conditions of use, as detailed in Unit V.A.3. EPA is
requesting public comment regarding the need for exemptions from the
rule (and under what specific circumstances), including exemptions from
the proposed regulatory action and the primary alternative regulatory
action, pursuant to the provisions of TSCA section 6(g).
    TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
TSCA section 6(a) rules, to consider and include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. A
description of all TSCA section 6 requirements considered in developing
this proposed regulatory action is in Unit III.B.3., and Unit VI.B.
includes more information regarding EPA's consideration of exemptions
and alternatives. TSCA section 6(c)(2)(C) requires that, in deciding
whether to prohibit or restrict in a manner that substantially prevents
a specific condition of use and in setting an appropriate transition
period for such action, EPA consider, to the extent practicable,
whether technically and economically feasible alternatives that benefit
health or the environment will be reasonably available as substitutes
when the proposed prohibition or restriction takes effect. Unit VI.B.
includes more information regarding EPA's consideration of
alternatives, and Units IV. and VII. provide more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
    EPA carried out required consultations as described in this unit
and also considered impacts on children's environmental health as part
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
    EPA conducted consultations and outreach in developing this
proposed regulatory action. The Agency held a federalism consultation
from July 22, 2021, until October 22, 2021, as part of this rulemaking
process and pursuant to Executive Order 13132. This included a
background presentation on September 9, 2021, and a consultation
meeting on July 22, 2021. During the consultation, EPA met with State
and local officials early in the process of developing the proposed
action in order to receive meaningful and timely input into its
development (Ref. 26). During the consultation, participants and EPA
discussed preemption; the authority given under TSCA section 6 to
regulate identified unreasonable risk; which activities would be
potentially regulated in the proposed rule; TSCA reporting
requirements; key local constituencies; and the relationship between
TSCA and existing statutes, particularly the Clean Water Act (CWA) and
the Safe Drinking Water Act (SDWA) (Ref. 26).
    TCE is not manufactured (including imported), processed,
distributed in commerce, or regulated by Tribal governments. However,
EPA consulted with Tribal officials during the development of this
proposed action (Ref. 27). The Agency held a Tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8,
2021. Tribal officials were given the opportunity to meaningfully
interact with EPA risk managers concerning the current status of risk
management. During the consultation, participants and EPA discussed
concerns from Tribal members about the TCE OSHA exposure limit being
outdated, Tribal interest in seeing TCE

banned, and concerns that third party disposal may be occurring near
Tribal lands, with a particular interest in protecting workers at
publicly owned treatment works (Ref. 27). EPA received no written
comments as part of this consultation.
    In addition to the formal consultations, EPA also conducted
outreach to advocates of communities that might be subject to
disproportionate risk from the exposures to TCE, such as communities
with environmental justice concerns. EPA's Environmental Justice (EJ)
consultation occurred from June 3, 2021, through August 20, 2021. On
June 16 and July 6, 2021, EPA held public meetings as part of this
consultation. These meetings were held pursuant to Executive Orders
12898 and 14008. EPA received three written comments following the EJ
meetings, in addition to oral comments provided during the consultation
(Refs. 28, 29, 30). In general, commenters supported strong regulation
of TCE to protect lower-income communities and workers, strong outreach
to affected communities, encouraged EPA to follow the National
Institute for Occupational Safety and Health (NIOSH) hierarchy of
controls, favored prohibitions, and noted the uncertainty, and, in some
cases, inadequacy, of personal protective equipment (Ref. 31).
    As required by section 609(b) of the Regulatory Flexibility Act
(RFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to
obtain advice and recommendations from small entity representatives
(SERs) that potentially would be subject to this proposed rule's
requirements (Ref. 32). EPA met with SERs before and during Panel
proceedings, on October 28, 2022, and January 31, 2023. Panel
recommendations are in Unit XI.C. and in the Initial Regulatory
Flexibility Analysis (Ref. 33), the Panel report is in the docket (Ref.
32).
    Units XI.C., XI.E., XI.F., and XI.J. provide more information
regarding the consultations.
2. Other Stakeholder Engagement
    In addition to the formal consultations described in Unit XI., EPA
held a webinar on December 15, 2020, providing an overview of the TSCA
risk management process and the risk evaluation findings for TCE. EPA
also presented on the risk evaluation and risk management under TSCA
for TCE at a Small Business Administration small business roundtable on
December 18, 2020. At both events EPA staff provided an overview of the
TSCA risk management process and the findings in the 2020 Risk
Evaluation for TCE (Ref. 34). Attendees of these meetings were given an
opportunity to voice their concerns regarding the risk evaluation and
risk management.
    Furthermore, EPA engaged in discussions with representatives from
different industries, non-governmental organizations, technical experts
and users of TCE. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 35); meeting
materials and summaries are also in the docket. The purpose of these
discussions was to create awareness and educate stakeholders and
regulated entities on the provisions for risk management required under
TSCA section 6(a); explain the risk evaluation findings; obtain input
from manufacturers, processors, distributors, users, academics,
advisory councils, and members of the public health community about
uses of TCE; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to TCE under the
conditions of use; understand the importance of TCE in the various uses
subject to this proposed rule; compile knowledge about critical uses,
substitute chemicals or alternative methods; identify various standards
and performance specifications; and generate potential risk reduction
strategies. EPA has met with, or otherwise communicated with, a variety
of companies, trade associations and non-governmental public interest
organizations to discuss the topics outlined in this paragraph; a list
of external meetings held during the development of this proposed rule
is in the docket (Ref. 35).
3. Children's Environmental Health
    The EPA 2021 Policy on Children's Health (Ref. 36) requires EPA to
protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
early childhood and through adolescence until 21 years of age) and
lifelong health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk
evaluations ``to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' Infants, children, and
pregnant women are listed as examples of subpopulations based on
lifestage that may be considered relevant ``potentially exposed or
susceptible subpopulations'' in the TSCA section 3(12) definition of
that term. In addition, TSCA section 6(a) requires EPA to apply one or
more risk management requirements under TSCA section 6(a) so that TCE
no longer presents an unreasonable risk (including unreasonable risk to
PESS). Furthermore, TSCA 6(c)(2)(B) requires EPA to ``factor in, to the
extent practicable,'' the considerations under TSCA section 6(c)(2)(A)
when selecting among prohibitions and other restrictions in TSCA
section 6(a) rules, including taking into consideration the magnitude
of exposure to human health, as further discussed in Unit IV.
    The 2020 Risk Evaluation for TCE evaluated the hazards of TCE to
all lifestages. Evidence of developmental hazards were observed for
increased resorptions, fetal cardiac defects and decreased rearing
activity (i.e., neurotoxicity). These effects occur in the offspring
exposed either in utero or postnatally, with older pregnant women
identified as especially susceptible to cardiac defects in their
developing fetus based on epidemiological data. Adverse health effects
to reproduction following TCE exposure include decreased normal sperm
morphology and hyperzoospermia along with delayed onset of birth. The
most sensitive non-cancer hazard identified for non-reproductive or
developmental effects is autoimmunity following chronic exposure to
TCE.
    The 2020 Risk Evaluation for TCE considered impacts on both
children and adults from occupational and consumer use from inhalation
and dermal exposures, as applicable. The 2020 Risk Evaluation for TCE
identified consumers and bystanders associated with use of TCE-
containing consumer products as potentially exposed and susceptible
subpopulations due to greater exposure. Consumer users are considered
to include adults as well as children as young as 11. Bystanders in the
home exposed via inhalation are considered to include any age group
from infant (including breast-fed infants) to adult (including
elderly), including pregnant women and individuals of reproductive age.
Younger lifestages are likely exposed to higher internal dose
concentrations of TCE than adults due to relative physiological
differences in body weight, breathing rate, and other parameters. A
further discussion on the magnitude of health effects and EPA's
consideration of these health effects in this proposed rule is in Unit
IV.

B. Regulatory Assessment of TCE

1. Description of Conditions of Use
    This unit describes the TSCA conditions of use whose risk EPA
evaluated and considered in making its unreasonable risk determination
for the chemical substance TCE. Condition of use descriptions were
obtained from EPA sources such as CDR use codes, the 2020 Risk
Evaluation for TCE and related documents, as well as the Organisation
for Economic Co-operation and Development harmonized use codes and
stakeholder engagements. For additional description of the conditions
of use, including process descriptions and worker activities considered
in the risk evaluation, see the Problem Formulation of the 2020 Risk
Evaluation for TCE, the 2020 Risk Evaluation for TCE, and supplemental
files (Refs. 37, 1, 38). EPA acknowledges that some of the terms used
in this unit may also be defined under other statutes; however, the
descriptions here are intended to provide clarity to the regulated
entities who would be subject to the provisions of this proposed rule
under TSCA section 6(a).
a. Manufacturing
i. Domestic Manufacture
    This condition of use refers to the making or producing of a
chemical substance within the United States (including manufacturing
for export), or the extraction of a component chemical substance from a
previously existing chemical substance or a complex combination of
substances. This description does not apply to TCE production as a
byproduct, including during the manufacture of 1,2-dichloroethane,
which EPA intends to consider in the risk evaluation for 1,2-
dichloroethane (Ref. 39).
ii. Import
    This condition of use refers to the act of causing a chemical
substance or mixture to arrive within the customs territory of the
United States.
b. Processing
i. Processing as a Reactant/Intermediate
    This condition of use refers to processing TCE in chemical
reactions for the manufacturing of another chemical substance or
product, notably including but not limited to 1,1,1,2-
tetrafluoroethane, an HFC also known as HFC-134a, which is used as a
refrigerant and in fluorocarbon blends for refrigerants. This condition
of use includes reuse of byproduct or residual TCE as a reactant.
ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction
Product
    This condition of use refers to when TCE is added to a product (or
product mixture) prior to further distribution of the product; such
products include but are not limited to solvents (for cleaning or
degreasing), adhesives and sealant chemicals, and solvents that become
part of a product formulation or mixture (e.g., lubricants and greases,
paints and coatings, other uses).
iii. Processing: Incorporation Into Articles
    This condition of use refers to when a chemical substance becomes
an integral component of an article distributed for industrial,
commercial, or consumer use.
iv. Processing: Repackaging
    This condition of use refers to the preparation of a chemical
substance for distribution in commerce in a different form, state, or
quantity. This includes but is not limited to transferring the chemical
from a bulk container into smaller containers.
v. Processing: Recycling
    This condition of use refers to the process of managing used
solvents that are collected, either on-site or transported to a third-
party site, for commercial purpose other than disposal. Spent solvents
can be restored via solvent reclamation/recycling. The recovery process
may involve an initial vapor recovery or mechanical separation step
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and Commercial Use as Solvent for Open-Top Batch Vapor
Degreasing
    This condition of use refers to the process of heating TCE to its
volatilization point and using its vapor to remove dirt, oils, greases,
and other surface contaminants (such as drawing compounds, cutting
fluids, coolants, solder flux, and lubricants) from metal parts,
electronics, or other articles in batch open-top vapor degreasers
(OTVDs).
ii. Industrial and Commercial Use as Solvent for Closed-Loop Batch
Vapor Degreasing
    This condition of use refers to the process of heating TCE to its
volatilization point and using its vapor to remove dirt, oils, greases,
and other surface contaminants (such as drawing compounds, cutting
fluids, coolants, solder flux, and lubricants) from metal parts,
electronics, or other articles in batch closed-loop vapor degreasers.
iii. Industrial and Commercial Use as Solvent for In-Line Conveyorized
Vapor Degreasing
    This condition of use refers to the process of heating TCE to its
volatilization point and using its vapors to remove dirt, oils,
greases, and other surface contaminants from textiles, glassware, metal
surfaces, and other articles using in-line conveyorized degreasing
machines.
iv. Industrial and Commercial Use as Solvent for In-Line Web Cleaner
Vapor Degreasing
    This condition of use refers to the process of heating TCE to its
volatilization point and using its vapors to remove dirt, oils,
greases, and other surface contaminants from textiles, glassware, metal
surfaces, and other articles using in-line web cleaning degreasing
machines.
v. Industrial and Commercial Use as Solvent for Cold Cleaning
    This condition of use refers to the industrial and commercial use
of TCE as a non-boiling solvent in cold cleaning to dissolve oils,
greases and other surface contaminants from textiles, glassware, metal
surfaces, and other articles.
vi. Industrial and Commercial Use as a Solvent for Aerosol Spray
Degreaser/Cleaner and Mold Release
    This condition of use refers to industrial and commercial use of
TCE in aerosol degreasing as an aerosolized solvent spray, typically
applied from a pressurized can, to remove residual contaminants from
fabricated parts or machinery (including circuit boards and
electronics). This description also applies to the use of TCE in
products to remove dirt, grease, stains, spots, and foreign matter,
including but not limited to release agent residues, from molds and
casting surfaces.
vii. Industrial and Commercial Use as a Lubricant and Grease in Tap and
Die Fluid
    This condition of use refers to industrial and commercial use of
TCE in products such as, but not limited to, metalworking, cutting, and
tapping fluid to reduce friction, heat generation and wear, to assist
in metal shaping, and to protect the part being shaped from oxidation.
This description does not apply to use of TCE in products intended as
penetrating lubricant, which are described in a different condition of
use.

viii. Industrial and Commercial Use as a Lubricant and Grease in
Penetrating Lubricant
    This condition of use refers to the industrial and commercial use
of TCE in products as a lubricant and grease in penetrating lubricant,
to reduce friction, heat generation and wear between surfaces. This
description does not apply to use of TCE in products intended as
metalworking, cutting and tapping fluids, which are described in a
different condition of use.
ix. Industrial and Commercial Use as an Adhesive and Sealant in
Solvent-Based Adhesives and Sealants; Tire Repair Cement/Sealer; Mirror
Edge Sealant
    This condition of use refers to industrial and commercial use of
TCE in adhesive and sealant products to promote bonding between other
substances, promote adhesion of surfaces, or prevent seepage of
moisture or air.
x. Industrial and Commercial Use as a Functional Fluid in Heat Exchange
Fluid
    This condition of use refers to the industrial and commercial use
of TCE as a functional fluid in heat exchange fluid used to transmit or
to remove heat from another material in a closed system.
xi. Industrial and Commercial Use in Paints and Coatings as a Diluent
in Solvent-Based Paints and Coating
    This condition of use refers to industrial and commercial use of
TCE in paints and coatings that are applied to surfaces to enhance
properties such as, but not limited to, water repellency, gloss, fade
resistance, ease of application, or foam prevention.
xii. Industrial and Commercial Use in Cleaning and Furniture Care
Products in Carpet Cleaner and Wipe Cleaning
    This condition of use refers to the industrial and commercial use
of TCE in products to remove dirt, grease, stains, spots, and foreign
matter from furniture and furnishings, including but not limited to
carpets and rugs. This description also applies to use of TCE in
degreasing and cleaning products to remove dirt, grease, stains, spots,
and foreign matter from furniture and furnishings or to cleanse,
sanitize, bleach, scour, polish, protect, or improve the appearance of
surfaces through wipe cleaning. This description does not apply to the
use of TCE as a spot remover for laundry and dishwashing, which is
described in a different condition of use.
xiii. Industrial and Commercial Use in Laundry and Dishwashing Products
in Spot Remover
    This condition of use refers to industrial and commercial use of
TCE as a solvent in products for cleaning in laundry and dishwashing
applications to remove dirt, grease, stains, spots, and foreign matter
from garments and dishware.
xiv. Industrial and Commercial Use in Arts, Crafts, and Hobby Materials
in Fixatives and Finishing Spray Coatings
    This condition of use refers to the industrial and commercial use
of TCE in aerosol products, such as, but not limited to, fixatives,
shellacs, or other spray applied coatings intended to cover or hold
other arts and crafts materials to a surface.
xv. Industrial and Commercial Use in Corrosion Inhibitors and Anti-
Scaling Agents
    This condition of use refers to the industrial and commercial use
of TCE in corrosion inhibitors and anti-scaling agents as a chemical
substance used to prevent or retard corrosion or the formation of
scale. As a corrosion inhibitor, TCE is used to prevent or retard
corrosion on metallic materials. As an anti-scaling agent, TCE is added
to products to prevent the build-up of inorganic oxide deposits.
xvi. Industrial and Commercial Use in Processing Aids in Process
Solvent Used in Battery Manufacture; Process Solvent Used in Polymer
Fabric Spinning, Fluoroelastomer Manufacture and Alcantara Manufacture;
Extraction Solvent Used in Caprolactam Manufacture; Precipitant Used in
Beta-Cyclodextrin Manufacture
    This condition of use refers to industrial and commercial use of
TCE as a processing aid. A process solvent is a chemical substance used
to improve the processing characteristics or the operation of process
equipment when added to a process or to a substance or mixture to be
processed. The chemical substance is not intended to become a part of
the reaction product nor has function in the reaction product.
xvii. Industrial and Commercial Use as Ink, Toner, and Colorant
Products in Toner Aid
    This condition of use refers to the industrial and commercial use
of TCE in ink, toner, and colorant products in toner aid as chemical
substance used for writing, printing, creating an image on paper and
other substrates, or applied to substrates to change their color or
hide images. This includes but is not limited to pigmented liquids,
toners or powders contained in cartridges, bottles, or other dispensers
used in printers and copy machines. This category includes printing
inks for commercial applications.
xviii. Industrial and Commercial Use in Automotive Care Products in
Brake and Parts Cleaner
    This condition of use refers to the industrial and commercial use
of TCE in products to remove dirt, grease, stains, and foreign matter
from interior and exterior vehicle surfaces. This description includes
but is not limited to use of products for motorized vehicle maintenance
and their parts.
xix. Industrial and Commercial Use in Apparel and Footwear Care
Products in Shoe Polish
    This condition of use refers to the industrial or commercial use of
TCE in apparel and footwear care products as post-market waxes,
polishes, or other mediums and applied to footwear, textiles, or
fabrics to impart color or other desirable properties.
xx. Industrial and Commercial Use in Hoof Polish, Gun Scrubber, Pepper
Spray, Other Miscellaneous Industrial and Commercial Uses
    This condition of use refers to the industrial and commercial use
of TCE in which it is expected to act similar to a cleaning solvent
used to remove dirt or other contaminants from substrates. This
description also refers to other miscellaneous products which contain
TCE as an additive to impart or enhance desirable properties of another
material (e.g., adhesive, sealant, propellant). Additionally, this
condition of use refers to the industrial and commercial use of TCE,
often in small quantities, in a laboratory for chemical analysis (e.g.,
to test hot mix asphalt binder content, as a reference standard, etc.),
chemical synthesis, extracting and purifying other chemicals,
dissolving other substances, and similar activities.
d. Consumer Use
i. Consumer Use as a Solvent in Brake and Parts Cleaner
    This condition of use refers to the consumer use of TCE in products
to remove dirt, grease, stains, and foreign matter from interior and
exterior vehicle surfaces, particularly in brake cleaner and parts
cleaner.
ii. Consumer Use as a Solvent in Aerosol Electronic Degreaser/Cleaner
    This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used

to remove dirt, grease, stains, spots, and foreign matter through a
process that uses an aerosolized solvent spray, typically applied from
a pressurized can, to remove residual contaminants from electronics.
iii. Consumer Use as a Solvent in Liquid Electronic Degreaser/Cleaner
    This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses a
liquid solvent to remove residual contaminants from electronics.
iv. Consumer Use as a Solvent in Aerosol Spray Degreaser/Cleaner
    This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses
an aerosolized solvent spray, typically applied from a pressurized can,
to remove residual contaminants from metals and other fabricated
materials not described elsewhere in this unit.
v. Consumer Use as a Solvent in Liquid Degreaser/Cleaner
    This condition of use refers to the consumer use of TCE as a
solvent in liquid degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter from metals and other
fabricated materials not described elsewhere.
vi. Consumer Use as a Solvent in Aerosol Gun Scrubber
    This condition of use refers to the consumer use of TCE as a
solvent in aerosol products in which it is expected to act similar to a
cleaning solvent used to remove residue, dirt, grease, or other
contaminants, in particular but not limited to gun scrubber.
vii. Consumer Use as a Solvent in Liquid Gun Scrubber
    This condition of use refers to the consumer use of TCE as a
solvent in liquid products in which it is expected to act similar to a
cleaning solvent used to remove residue, dirt, grease, or other
contaminant, in particular but not limited to gun scrubber.
viii. Consumer Use as a Solvent in Mold Release
    This condition of use refers to the consumer use of TCE in mold
release products to create barriers to prevent certain materials from
adhering to each other, and assist in the removal of dirt, grease,
oils, and other contaminants from metal molds.
ix. Consumer Use as a Solvent in Aerosol Tire Cleaner
    This condition of use refers to the consumer use of TCE as an
additive in aerosol products to impart or enhance desirable properties
of another material, particularly in use as tire cleaner.
x. Consumer Use as a Solvent in Liquid Tire Cleaner
    This condition of use refers to the consumer use of TCE as an
additive in liquid products to impart or enhance desirable properties
of another material, particularly in use as tire cleaner.
xi. Consumer Use as a Lubricant and Grease in Tap and Die Fluid
    This condition of use refers to the consumer use of TCE in products
to reduce friction, heat generation and wear between solid surfaces,
particularly in tap and die fluid.
xii. Consumer Use as a Lubricant and Grease in Penetrating Lubricant
    This condition of use refers to the consumer use of TCE in products
to reduce friction, heat generation and wear between solid surfaces,
particularly in penetrating lubricant.
xiii. Consumer Use as an Adhesive and Sealant in Solvent-Based Adhesive
and Sealants
    This condition of use refers to the consumer use of TCE as a
solvent in single or two component products used to fasten other
materials together or prevent the passage of liquid or gas. This
description does not apply to products for mirror edge sealant or tire
repair, which are described in different conditions of use.
xiv. Consumer Use as an Adhesive and Sealant in Mirror Edge Sealant
    This condition of use refers to the consumer use of TCE in single
or two component products used to fasten other materials together or
prevent the passage of liquid or gas, particularly in mirror edge
sealant.
xv. Consumer Use as an Adhesive and Sealant in Tire Repair Cement/
Sealer
    This condition of use refers to the consumer use of TCE in single
or two component products used to fasten other materials together or
prevent the passage of liquid or gas, particularly in cement or sealant
for tire repair.
xvi. Consumer Use as a Cleaning and Furniture Care Product in Carpet
Cleaner
    This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products used to remove dirt,
grease, stains, spots, foreign matter, and residual contaminants,
particularly in carpet cleaner.
xvii. Consumer Use as a Cleaning and Furniture Care Product in Aerosol
Spot Remover
    This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses
an aerosolized solvent spray, typically applied from a pressurized can,
to remove residual contaminants, particularly in aerosol spot remover.
xviii. Consumer Use as a Cleaning and Furniture Care Product in Liquid
Spot Remover
    This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products in the form of a solid
or liquid cleaner, used to remove dirt, grease, stains, spots, foreign
matter, and residual contaminants, particularly in liquid spot remover.
xix. Consumer Use in Arts, Crafts, and Hobby Materials in Fixative and
Finishing Spray Coatings
    This condition of use refers to the consumer use of TCE in arts,
crafts, and hobby products that uses an aerosolized solvent spray,
typically applied from a pressurized can, intended to cover or hold
other arts and crafts materials to a surface, particularly in fixative
and finishing spray coatings.
xx. Consumer Use in Apparel and Footwear Products in Shoe Polish
    This condition of use refers to the consumer use of TCE in apparel
and footwear care products as post-market waxes, polishes, or other
mediums and applied to footwear, textiles, or fabrics to impart color
or other desirable properties.
xxi. Consumer Use in Fabric Spray
    This condition of use refers to the consumer use of TCE in aerosol
products, typically applied from a pressurized can, as an additive to
enhance desirable properties of another material, particularly in
fabric spray and as an anti-fray spray.

xxii. Consumer Use in Film Cleaner
    This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in film cleaner.
xxiii. Consumer Use in Hoof Polish
    This condition of use refers to the consumer use of TCE as an
additive to impart or enhance desirable properties of another material,
particularly in hoof polish.
xxiv. Consumer Use in Toner Aid
    This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in toner aid.
e. Disposal
    This condition of use refers to the process of disposing of
generated waste streams of TCE that are collected either on-site or
transported to a third-party site. This includes the mixing of TCE with
wastewater and the discharge of TCE-contaminated wastewater pursuant to
a NPDES permit, and specifically includes discharge to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
While EPA views the disposal condition of use under TSCA broadly (see,
e.g., EPA's proposed regulation on certain conditions of use of
chrysotile asbestos (Ref. 40), for the purpose of this rulemaking under
TSCA section 6(a), based on the underlying analysis in the 2020 TCE
risk evaluation, EPA's proposed regulations specifically address the
risk to PESS from disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works. EPA recognizes
that this includes activities that may not be considered disposal under
other statutes, such as RCRA and the CWA.
f. Terminology in This Proposed Rule
    For purposes of this proposed rulemaking, ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for TCE for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority over ``any manner or method of
commercial use'' under TSCA section 6(a)(5) to reach both.
    Additionally, in the 2020 Risk Evaluation for TCE, EPA identified
and assessed all known, intended, and reasonably foreseen industrial,
commercial, and consumer uses of TCE in order to determine whether TCE
as a whole chemical substance presents unreasonable risk to health and
the environment. EPA determined that a substantial amount of the
industrial, commercial, and consumer uses of TCE evaluated in the 2020
Risk Evaluation for TCE present unreasonable risk of injury to health.
As such, for purposes of this risk management rulemaking, ``consumer
use'' refers to all consumer uses including known, intended, and
reasonably foreseen consumer uses for TCE. Likewise, for the purpose of
this risk management rulemaking ``industrial and commercial use''
refers to all industrial and commercial uses, including known,
intended, or reasonably foreseen TCE industrial and commercial use.
    EPA is not proposing to incorporate the descriptions of known,
intended, or reasonably foreseen conditions of use in Unit III.B.1.a.
through e. into the regulatory text as definitions because these
conditions of use represent those evaluated in the 2020 Risk Evaluation
for TCE, whereas the regulatory text applies to all consumer and
industrial/commercial uses. EPA requests comment on whether EPA should
promulgate definitions for those conditions of use evaluated in the
2020 Risk Evaluation for TCE, and, if so, whether the descriptions in
this unit are consistent with the conditions of use evaluated in the
2020 Risk Evaluation for TCE and whether they provide a sufficient
level of detail to improve the clarity and readability of the
regulation if EPA were to promulgate a regulation controlling
industrial and commercial conditions of use that pertained only to the
listed industrial and commercial conditions of use evaluated in the
2020 Risk Evaluation for TCE.
    EPA further notes that this proposed rule does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but
are not limited to, any pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured,
processed, or distributed in commerce for use as a pesticide; and any
food, food additive, drug, cosmetic, or device, as defined in section
201 of the Federal Food, Drug, and Cosmetic Act (FFDCA), when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic or device.
2. Description of Unreasonable Risk Under the Conditions of Use
    EPA has determined that TCE presents an unreasonable risk of injury
to human health under the conditions of use based on acute and chronic
non-cancer risks and chronic cancer risks (Ref. 2). As described in the
TSCA section 6(b) 2020 Risk Evaluation for TCE, EPA identified non-
cancer adverse effects from acute and chronic inhalation and dermal
exposures to TCE, and for cancer from chronic inhalation and dermal
exposures to TCE (Ref. 1). In the TCE risk characterization, the
endpoints identified by EPA as the basis for the unreasonable risk
determination in the Risk Conclusions were immunosuppression effects
for acute inhalation and dermal exposures, and autoimmunity effects for
chronic inhalation and dermal exposures (Ref. 1). Additional risks
associated with other non-cancer adverse effects (e.g., developmental
toxicity, immunosuppression, liver toxicity, kidney toxicity,
neurotoxicity, autoimmunity, and reproductive toxicity) were identified