Proposed Rule2023-23010
Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
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Published
October 31, 2023
Effective
December 15, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 209 (Tuesday, October 31, 2023)</title>
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[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Proposed Rules]
[Pages 74712-74794]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23010]
[[Page 74711]]
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
[[Page 74712]]
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Gabriela Rossner, Existing
Chemicals Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number (202) 565-2426; email
address: <a href="/cdn-cgi/l/email-protection#752136305b21263634351005145b121a03"><span class="__cf_email__" data-cfemail="0a5e494f245e59494b4a6f7a6b246d657c">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#c490978785e98cabb0a8adaaa184a1b4a5eaa3abb2"><span class="__cf_email__" data-cfemail="82d6d1c1c3afcaedf6eeebece7c2e7f2e3ace5edf4">[email protected]</span></a>.
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:
<bullet> Crude Petroleum Extraction (NAICS code 211120);
<bullet> Fossil Fuel Electric Power Generation (NAICS code 221112);
<bullet> Other Electric Power Generation (NAICS code 221118);
<bullet> Broadwoven Fabric Mills (NAICS code 313210);
<bullet> Narrow Fabric Mills and Schiffli Machine Embroidery (NAICS
code 313220);
<bullet> Nonwoven Fabric Mills (NAICS code 313230);
<bullet> Textile and Fabric Finishing Mills (NAICS code 313310);
<bullet> Fabric Coating Mills (NAICS code 313320);
<bullet> Wood Window and Door Manufacturing (NAICS code 321911);
<bullet> Prefabricated Wood Building Manufacturing (NAICS code
321992);
<bullet> Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220);
<bullet> Petroleum Refineries (NAICS code 324110);
<bullet> All Other Petroleum and Coal Products Manufacturing (NAICS
code 324199);
<bullet> Petrochemical Manufacturing (NAICS code 325110);
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
<bullet> Ethyl Alcohol Manufacturing (NAICS code 325193);
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
<bullet> Plastics Material and Resin Manufacturing (NAICS code
325211);
<bullet> Medicinal and Botanical Manufacturing (NAICS code 325411);
<bullet> Pharmaceutical Preparation Manufacturing (NAICS code
325412);
<bullet> Paint and Coating Manufacturing (NAICS code 325510);
<bullet> Adhesive Manufacturing (NAICS code 325520);
<bullet> Polish and Other Sanitation Good Manufacturing (NAICS code
325612);
<bullet> Photographic Film, Paper, Plate and Chemical Manufacturing
(NAICS code 325992);
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
<bullet> Polystyrene Foam Product Manufacturing (NAICS code
326140);
<bullet> Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS code 326150);
<bullet> Tire Manufacturing (except Retreading) (NAICS code
326211);
<bullet> Tire Retreading (NAICS code 326212);
<bullet> Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220);
<bullet> Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291);
<bullet> All Other Rubber Product Manufacturing (NAICS code
326299);
[[Page 74713]]
<bullet> Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110);
<bullet> Gypsum Product Manufacturing (NAICS code 327420);
<bullet> Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
code 331110);
<bullet> Iron and Steel Pipe and Tube Manufacturing from Purchased
Steel (NAICS code 331210);
<bullet> Rolled Steel Shape Manufacturing (NAICS code 331221);
<bullet> Steel Wire Drawing (NAICS code 331222);
<bullet> Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
<bullet> Copper Rolling, Drawing, Extruding, and Alloying (NAICS
code.331420);
<bullet> Nonferrous Metal (except Copper and Aluminum) Rolling,
Drawing and Extruding (NAICS code 331491);
<bullet> Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492);
<bullet> Nonferrous Metal Die-Casting Foundries (NAICS code
331523);
<bullet> Iron and Steel Forging (NAICS code 332111);
<bullet> Nonferrous Forging (NAICS code 332112);
<bullet> Custom Roll Forming (NAICS code 332114);
<bullet> Powder Metallurgy Part Manufacturing (NAICS code 332117);
<bullet> Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119);
<bullet> Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215);
<bullet> Saw Blade and Handtool Manufacturing (NAICS code 332216);
<bullet> Metal Window and Door Manufacturing (NAICS code 332321);
<bullet> Sheet Metal Work Manufacturing (NAICS code 332322);
<bullet> Ornamental and Architectural Metal Work Manufacturing
(NAICS code 332323);
<bullet> Power Boiler and Heat Exchanger Manufacturing (NAICS code
332410);
<bullet> Metal Tank (Heavy Gauge) Manufacturing (NAICS code
332420);
<bullet> Metal Can Manufacturing (NAICS code 332431);
<bullet> Other Metal Container Manufacturing (NAICS code 332439);
<bullet> Hardware Manufacturing (NAICS code 332510);
<bullet> Spring Manufacturing (NAICS code 332613);
<bullet> Other Fabricated Wire Product Manufacturing (NAICS code
332618);
<bullet> Machine Shops (NAICS code 332710);
<bullet> Precision Turned Product Manufacturing (NAICS code
332721);
<bullet> Bolt, Nut, Screw, Rivet and Washer Manufacturing (NAICS
code 332722);
<bullet> Metal Heat Treating (NAICS code 332811);
<bullet> Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812);
<bullet> Electroplating, Plating, Polishing, Anodizing and Coloring
(NAICS code 332813);
<bullet> Industrial Valve Manufacturing (NAICS code 332911);
<bullet> Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912);
<bullet> Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913);
<bullet> Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919);
<bullet> Ball and Roller Bearing Manufacturing (NAICS code 332991);
<bullet> Small Arms Ammunition Manufacturing (NAICS code 332992);
<bullet> Ammunition (except Small Arms) Manufacturing (NAICS code
332993);
<bullet> Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994);
<bullet> Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996);
<bullet> All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999);
<bullet> Farm Machinery and Equipment Manufacturing (NAICS code
333111);
<bullet> Lawn and Garden Tractor and Home Lawn and Garden Equipment
Manufacturing (NAICS code 333112);
<bullet> Construction Machinery Manufacturing (NAICS code 333120);
<bullet> Mining Machinery and Equipment Manufacturing (NAICS code
333131);
<bullet> Oil and Gas Field Machinery and Equipment Manufacturing
(NAICS code 333132);
<bullet> Food Product Machinery Manufacturing (NAICS code 333241);
<bullet> Semiconductor Machinery Manufacturing (NAICS code 333242);
<bullet> Sawmill, Woodworking, and Paper Machinery Manufacturing
(NAICS code 333243);
<bullet> Printing Machinery and Equipment Manufacturing (NAICS code
333244);
<bullet> Other Industrial Machinery Manufacturing (NAICS code
333249);
<bullet> Optical Instrument and Lens Manufacturing (NAICS code
333314);
<bullet> Photographic and Photocopying Equipment Manufacturing
(NAICS code 333316);
<bullet> Other Commercial and Service Industry Machinery
Manufacturing (NAICS code 333318);
<bullet> Industrial and Commercial Fan and Blower and Air
Purification Equipment Manufacturing (NAICS code 333413);
<bullet> Heating Equipment (except Warm Air Furnaces) Manufacturing
(NAICS code 333414);
<bullet> Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415);
<bullet> Industrial Mold Manufacturing (NAICS code 333511);
<bullet> Special Die and Tool, Die Set, Jig and Fixture
Manufacturing (NAICS code 333514);
<bullet> Cutting Tool and Machine Tool Accessory Manufacturing
(NAICS code 333515);
<bullet> Machine Tool Manufacturing (NAICS code 333517);
<bullet> Rolling Mill and Other Metalworking Machinery
Manufacturing (NAICS code 333519);
<bullet> Turbine and Turbine Generator Set Unit Manufacturing
(NAICS code 333611);
<bullet> Speed Changer, Industrial High-Speed Drive and Gear
Manufacturing (NAICS code 333612);
<bullet> Mechanical Power Transmission Equipment Manufacturing
(NAICS code 333613);
<bullet> Other Engine Equipment Manufacturing (NAICS code 333618);
<bullet> Air and Gas Compressor Manufacturing (NAICS code 333912);
<bullet> Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914);
<bullet> Elevator and Moving Stairway Manufacturing (NAICS code
333921);
<bullet> Conveyor and Conveying Equipment Manufacturing (NAICS code
333922);
<bullet> Overhead Traveling Crane, Hoist and Monorail System
Manufacturing (NAICS code 333923);
<bullet> Industrial Truck, Tractor, Trailer and Stacker Machinery
Manufacturing (NAICS code 333924);
<bullet> Power-Driven Hand Tool Manufacturing (NAICS code 333991);
<bullet> Welding and Soldering Equipment Manufacturing (NAICS code
333992);
<bullet> Packaging Machinery Manufacturing (NAICS code 333993);
<bullet> Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994);
<bullet> Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995);
<bullet> Fluid Power Pump and Motor Manufacturing (NAICS code
333996);
<bullet> Scale and Balance Manufacturing (NAICS code 333997);
<bullet> All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999);
<bullet> Audio and Video Equipment Manufacturing (NAICS code
334310);
<bullet> Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing (NAICS code 334416);
<bullet> Electronic Connector Manufacturing (NAICS code 334417);
[[Page 74714]]
<bullet> Printed Circuit Assembly (Electronic Assembly)
Manufacturing (NAICS code 334418);
<bullet> Other Electronic Component Manufacturing (NAICS code
334419);
<bullet> Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS code 334511);
<bullet> Automatic Environmental Control Manufacturing for
Residential, Commercial and Appliance Use (NAICS code 334512);
<bullet> Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513);
<bullet> Instrument Manufacturing for Measuring and Testing
Electricity and Electrical Signals (NAICS code 334515);
<bullet> Electric Lamp Bulb and Part Manufacturing (NAICS code
335110);
<bullet> Residential Electric Lighting Fixture Manufacturing (NAICS
code 335121);
<bullet> Commercial, Industrial and Institutional Electric Lighting
Fixture Manufacturing (NAICS code 335122);
<bullet> Other Lighting Equipment Manufacturing (NAICS code
335129);
<bullet> Major Household Appliance Manufacturing (NAICS code
335220);
<bullet> Power, Distribution and Specialty Transformer
Manufacturing (NAICS code 335311);
<bullet> Motor and Generator Manufacturing (NAICS code 335312);
<bullet> Switchgear and Switchboard Apparatus Manufacturing (NAICS
code 335313);
<bullet> Relay and Industrial Control Manufacturing (NAICS code
335314);
<bullet> Storage Battery Manufacturing (NAICS code 335911);
<bullet> Fiber Optic Cable Manufacturing (NAICS code 335921);
<bullet> Current-Carrying Wiring Device Manufacturing (NAICS code
335931);
<bullet> Carbon and Graphite Product Manufacturing (NAICS code
335991);
<bullet> Automobile Manufacturing (NAICS code 336111);
<bullet> Light Truck and Utility Vehicle Manufacturing (NAICS code
336112);
<bullet> Heavy Duty Truck Manufacturing (NAICS code 336120);
<bullet> Motor Vehicle Body Manufacturing (NAICS code 336211);
<bullet> Truck Trailer Manufacturing (NAICS code 336212);
<bullet> Motor Home Manufacturing (NAICS code 336213);
<bullet> Travel Trailer and Camper Manufacturing (NAICS code
336214);
<bullet> Motor Vehicle Gasoline Engine and Engine Parts
Manufacturing (NAICS code 336310);
<bullet> Motor Vehicle Electrical and Electronic Equipment
Manufacturing (NAICS code 336320);
<bullet> Motor Vehicle Steering and Suspension Components (except
Spring) Manufacturing (NAICS code 336330);
<bullet> Motor Vehicle Brake System Manufacturing (NAICS code
336340);
<bullet> Motor Vehicle Transmission and Power Train Parts
Manufacturing (NAICS code 336350);
<bullet> Motor Vehicle Seating and Interior Trim Manufacturing
(NAICS code 336360);
<bullet> Motor Vehicle Metal Stamping (NAICS code 336370);
<bullet> Other Motor Vehicle Parts Manufacturing (NAICS code
336390);
<bullet> Aircraft Manufacturing (NAICS code 336411);
<bullet> Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412);
<bullet> Other Aircraft Part and Auxiliary Equipment Manufacturing
(NAICS code 336413);
<bullet> Guided Missile and Space Vehicle Manufacturing (NAICS code
336414);
<bullet> Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415);
<bullet> Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419);
<bullet> Railroad Rolling Stock Manufacturing (NAICS code 336510);
<bullet> Ship Building and Repairing (NAICS code 336611);
<bullet> Boat Building (NAICS code 336612);
<bullet> Motorcycle, Bicycle and Parts Manufacturing (NAICS code
336991);
<bullet> Military Armored Vehicle, Tank and Tank Component
Manufacturing (NAICS code 336992);
<bullet> All Other Transportation Equipment Manufacturing (NAICS
code 336999);
<bullet> Wood Kitchen Cabinet and Counter Top Manufacturing (NAICS
code 337110);
<bullet> Upholstered Household Furniture Manufacturing (NAICS code
337121);
<bullet> Nonupholstered Wood Household Furniture Manufacturing
(NAICS code 337122);
<bullet> Metal Household Furniture Manufacturing (NAICS code
337124);
<bullet> Institutional Furniture Manufacturing (NAICS code 337127);
<bullet> Wood Office Furniture Manufacturing (NAICS code 337211);
<bullet> Surgical Appliance and Supplies Manufacturing (NAICS code
339113);
<bullet> Dental Equipment and Supplies Manufacturing (NAICS code
339114);
<bullet> Jewelry and Silverware Manufacturing (NAICS code 339910);
<bullet> Sporting and Athletic Goods Manufacturing (NAICS code
339920);
<bullet> Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991);
<bullet> Fastener, Button, Needle and Pin Manufacturing (NAICS code
339993);
<bullet> All Other Miscellaneous Manufacturing (NAICS code 339999);
<bullet> Metal Service Centers and Other Metal Merchant Wholesalers
(NAICS code 423510);
<bullet> Industrial Supplies Merchant Wholesalers (NAICS code
423510);
<bullet> Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690);
<bullet> Paint, Varnish, and Supplies Merchant Wholesalers (NAICS
code 424950);
<bullet> New Car Dealers (NAICS code 441110);
<bullet> Used Car Dealers (NAICS code 441120);
<bullet> Sporting Goods Stores (NAICS code 451110);
<bullet> Scheduled Passenger Air Transportation (NAICS code
481111);
<bullet> Other Support Activities for Air Transportation (NAICS
code 481111);
<bullet> Other Warehousing and Storage (NAICS code 493190);
<bullet> Motion Picture and Video Production (NAICS code 512110);
<bullet> Other Financial Vehicles (NAICS code 525990);
<bullet> Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715);
<bullet> Research and Development in the Social Sciences and
Humanities (NAICS code 541720);
<bullet> Offices of Other Holding Companies (NAICS code 551112);
<bullet> Carpet and Upholstery Cleaning Services (NAICS code
561740);
<bullet> Hazardous Waste Treatment and Disposal (NAICS code
562211);
<bullet> Solid Waste Landfill (NAICS code 562212);
<bullet> Materials Recovery Facilities (NAICS code 562920);
<bullet> Junior Colleges (NAICS code 611210);
<bullet> Colleges, Universities and Professional Schools (NAICS
code 611310);
<bullet> General Automotive Repair (NAICS code 811111);
<bullet> Automotive Exhaust System Repair (NAICS code 811112);
<bullet> Automotive Transmission Repair (NAICS code 811113);
<bullet> Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118);
<bullet> Automotive Body, Paint and Interior Repair and Maintenance
(NAICS code 811121);
<bullet> Automotive Glass Replacement Shops (NAICS code 811122);
<bullet> Automotive Oil Change and Lubrication Shops (NAICS code
811191);
[[Page 74715]]
<bullet> All Other Automotive Repair and Maintenance (NAICS code
811198);
<bullet> Consumer Electronics Repair and Maintenance (NAICS code
811211);
<bullet> Computer and Office Machine Repair and Maintenance (NAICS
code 811212);
<bullet> Communication Equipment Repair and Maintenance (NAICS code
811213);
<bullet> Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219);
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
<bullet> Home and Garden Equipment Repair and Maintenance (NAICS
code 811411);
<bullet> Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490);
<bullet> Coin-Operated Laundries and Drycleaners (NAICS code
812310);
<bullet> Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320); and
<bullet> 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-
[[Page 74716]]
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
[[Page 74717]]
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
[[Page 74718]]
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
[[Page 74719]]
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
[[Page 74720]]
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
[[Page 74721]]
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-
[[Page 74722]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
[[Page 74723]]
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
[[Page 74724]]
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.
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
<bullet> 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)).
<bullet> 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
[[Page 74725]]
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.
[[Page 74726]]
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.
[[Page 74727]]
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
[[Page 74728]]
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.
[[Page 74729]]
xxii. Consumer Use in Film Cleaner
This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in film cleaner.
xxiii. Consumer Use in Hoof Polish
This condition of use refers to the consumer use of TCE as an
additive to impart or enhance desirable properties of another material,
particularly in hoof polish.
xxiv. Consumer Use in Toner Aid
This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in toner aid.
e. Disposal
This condition of use refers to the process of disposing of
generated waste streams of TCE that are collected either on-site or
transported to a third-party site. This includes the mixing of TCE with
wastewater and the discharge of TCE-contaminated wastewater pursuant to
a NPDES permit, and specifically includes discharge to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
While EPA views the disposal condition of use under TSCA broadly (see,
e.g., EPA's proposed regulation on certain conditions of use of
chrysotile asbestos (Ref. 40), for the purpose of this rulemaking under
TSCA section 6(a), based on the underlying analysis in the 2020 TCE
risk evaluation, EPA's proposed regulations specifically address the
risk to PESS from disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works. EPA recognizes
that this includes activities that may not be considered disposal under
other statutes, such as RCRA and the CWA.
f. Terminology in This Proposed Rule
For purposes of this proposed rulemaking, ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for TCE for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority over ``any manner or method of
commercial use'' under TSCA section 6(a)(5) to reach both.
Additionally, in the 2020 Risk Evaluation for TCE, EPA identified
and assessed all known, intended, and reasonably foreseen industrial,
commercial, and consumer uses of TCE in order to determine whether TCE
as a whole chemical substance presents unreasonable risk to health and
the environment. EPA determined that a substantial amount of the
industrial, commercial, and consumer uses of TCE evaluated in the 2020
Risk Evaluation for TCE present unreasonable risk of injury to health.
As such, for purposes of this risk management rulemaking, ``consumer
use'' refers to all consumer uses including known, intended, and
reasonably foreseen consumer uses for TCE. Likewise, for the purpose of
this risk management rulemaking ``industrial and commercial use''
refers to all industrial and commercial uses, including known,
intended, or reasonably foreseen TCE industrial and commercial use.
EPA is not proposing to incorporate the descriptions of known,
intended, or reasonably foreseen conditions of use in Unit III.B.1.a.
through e. into the regulatory text as definitions because these
conditions of use represent those evaluated in the 2020 Risk Evaluation
for TCE, whereas the regulatory text applies to all consumer and
industrial/commercial uses. EPA requests comment on whether EPA should
promulgate definitions for those conditions of use evaluated in the
2020 Risk Evaluation for TCE, and, if so, whether the descriptions in
this unit are consistent with the conditions of use evaluated in the
2020 Risk Evaluation for TCE and whether they provide a sufficient
level of detail to improve the clarity and readability of the
regulation if EPA were to promulgate a regulation controlling
industrial and commercial conditions of use that pertained only to the
listed industrial and commercial conditions of use evaluated in the
2020 Risk Evaluation for TCE.
EPA further notes that this proposed rule does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but
are not limited to, any pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured,
processed, or distributed in commerce for use as a pesticide; and any
food, food additive, drug, cosmetic, or device, as defined in section
201 of the Federal Food, Drug, and Cosmetic Act (FFDCA), when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic or device.
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that TCE presents an unreasonable risk of injury
to human health under the conditions of use based on acute and chronic
non-cancer risks and chronic cancer risks (Ref. 2). As described in the
TSCA section 6(b) 2020 Risk Evaluation for TCE, EPA identified non-
cancer adverse effects from acute and chronic inhalation and dermal
exposures to TCE, and for cancer from chronic inhalation and dermal
exposures to TCE (Ref. 1). In the TCE risk characterization, the
endpoints identified by EPA as the basis for the unreasonable risk
determination in the Risk Conclusions were immunosuppression effects
for acute inhalation and dermal exposures, and autoimmunity effects for
chronic inhalation and dermal exposures (Ref. 1). Additional risks
associated with other non-cancer adverse effects (e.g., developmental
toxicity, immunosuppression, liver toxicity, kidney toxicity,
neurotoxicity, autoimmunity, and reproductive toxicity) were identified
for acute and chronic inhalation and dermal exposures, as well as
cancer (liver, kidney, and non-Hodgkin lymphoma) for chronic inhalation
and dermal exposures. EPA also concluded, based on EPA's Guidelines for
Carcinogen Risk Assessment (Ref. 41), that TCE is considered to be
carcinogenic by all routes of exposure and calculated cancer risks from
chronic inhalation and dermal exposures (Ref. 1). Unit IV. summarizes
the health effects and the magnitude of the exposures.
To make the unreasonable risk determination for TCE, EPA evaluated
exposures to potentially exposed or susceptible subpopulations
including workers, ONUs, consumer users, and bystanders to consumer use
by using reasonably available monitoring and modeling data for
inhalation and dermal exposures. (Ref. 1). EPA conducted a screening-
level analysis to assess potential risks from the air and water
pathways to fenceline communities. A discussion of EPA's analysis and
the expected effects of this rulemaking on fenceline communities is in
Unit VII.A.
For the 2020 Risk Evaluation for TCE, and as discussed in Unit
II.D.1. and Unit III.A.3., EPA considered PESS. EPA identified the
following groups as PESS: workers and ONUs, including men and women of
reproductive age, adolescents, and biologically susceptible
subpopulations; and consumer users (age 11 and older) and bystanders
(of any age group, including infants, toddlers, children, and elderly),
including biologically susceptible subpopulations. Additionally, older
pregnant women are identified as especially susceptible to cardiac
defects in their developing fetus based on
[[Page 74730]]
epidemiological data (Ref. 1). All PESS are included in the
quantitative and qualitative analyses described in the 2020 Risk
Evaluation for TCE and were considered in the determination of
unreasonable risk for TCE (Ref. 1, 2). As discussed in Unit II.D. and
Unit IV.B., the 2020 Risk Evaluation for TCE excluded the air and water
exposure pathways to the general population from the published risk
evaluations and may have caused some risks to be unaccounted for in the
risk evaluation. EPA considers these groups a subset of the general
population and categorizes them as fenceline communities; they may also
be considered PESS. See Unit VII.A. for further discussion on assessing
and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to address the
unreasonable risk for TCE.
As required, EPA developed a proposed regulatory action and one or
more primary alternative regulatory actions, which are described in
Units V.A. and V.B., respectively. To identify and select a regulatory
action, EPA considered the two routes of exposure driving the
unreasonable risk, inhalation and dermal, and the exposed populations.
For occupational conditions of use (see Unit III.B.1.f.), EPA
considered how it could directly regulate manufacturing (including
import), processing, distribution in commerce, industrial and
commercial use, or disposal to address the unreasonable risk. EPA does
not have direct authority to regulate consumer use. Therefore, EPA
considered how it could exercise its authority under TSCA to regulate
the manufacturing (including import), processing, and/or distribution
in commerce of TCE at different points in the supply chain to eliminate
exposures or restrict the availability of TCE and TCE-containing
products for consumer use in order to address the unreasonable risk.
As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions the effects of TCE on
health, which is described in Unit IV. EPA also factored into its
decisions, to the extent practicable: the effects of TCE on the
environment and the magnitude of exposure to TCE of human beings and
the environment, the benefits of TCE for various uses, and the
reasonably ascertainable economic consequences of the rule. In
evaluating the reasonably ascertainable economic consequences of the
rule, EPA considered: (i) The likely effect of the rule on the national
economy, small business, technological innovation, the environment, and
public health; (ii) The costs and benefits of the proposed regulatory
action and one or more primary alternative regulatory actions
considered; and (iii) The cost effectiveness of the proposed regulatory
action and of the one or more primary alternative regulatory actions
considered. See Unit VII. for further discussion related to TSCA
section 6(c)(2)(A) considerations, including the statement of effects
of the proposed rule with respect to these considerations.
EPA also considered the regulatory authority under TSCA and other,
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and
other EPA-administered statutes, to examine: (1) Whether there are
opportunities for all or part of risk management action on TCE to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or section 9(b); or (2) Whether TSCA section
6(a) regulation could include alignment of requirements and definitions
in and under existing statutes to minimize confusion to the regulated
entities and the general public.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit VI.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory action in Unit V.).
To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy of controls adopted by OSHA and NIOSH, with the goal of
identifying risk management control methods that are permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated entities
where appropriate. EPA considered the information presented in the 2020
Risk Evaluation for TCE, as well as additional input from stakeholders
(as described in Unit III.A.), and anticipated compliance strategies
from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory actions described
in Unit V. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit
VI.
IV. Considerations of Health Effects of TCE
TSCA section 6(a) rules must be promulgated ``in accordance with
subsection (c)(2).'' TSCA section 6(c)(2)(A) requires EPA, in proposing
and promulgating TSCA section 6(a) rules, to ``consider and publish a
statement based on reasonably available information'' with respect to
listed criteria, including the effects and magnitude of exposure to
human health and the environment, the benefits of the chemical
substance for various uses, and the reasonably ascertainable economic
consequences of the rule. Under TSCA section 6(c)(2)(B), EPA must
``factor in, to the extent practicable,'' the considerations under TSCA
section 6(c)(2)(A) when selecting among prohibitions and other
restrictions in TSCA section 6(a) rules. This section discusses the
health effects of TCE. Other TSCA section 6(c)(2) considerations are
discussed further in Unit VII.
EPA's analysis of the health effects of TCE is in the 2020 Risk
Evaluation (Ref. 1). This unit presents a summary of that information
and an explanation of how EPA considered that information in developing
the proposed and alternative regulatory options.
TCE has a large database of human health toxicity data. The 2020
Risk Evaluation for TCE identified several endpoints, such as kidney
toxicity, immunotoxicity, or developmental toxicity, and often a single
endpoint was examined by multiple studies. For acute exposures, EPA
identified non-cancer effects (developmental toxicity and
immunosuppression). For chronic exposures, EPA identified non-cancer
effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity,
reproductive toxicity, and developmental toxicity) as well as cancer
(liver, kidney, and non-Hodgkin lymphoma), with kidney cancer
identified as acting through a mutagenic mode of action (Ref. 1). As
discussed in this unit, the 2020 Risk Evaluation for TCE contains
quantitative risk estimates using several points of departure (PODs),
including both the immunotoxicity endpoints as well as the more
sensitive developmental toxicity endpoints, specifically fetal cardiac
defects, and both demonstrate that TCE presents risk.
Additionally, in developing the 2020 Risk Evaluation for TCE, EPA
analyzed
[[Page 74731]]
the reasonably available information to ascertain whether some human
subpopulations may have greater exposure or greater susceptibility than
the general population to the hazard posed by the chemical substance.
Factors affecting susceptibility examined in the reasonably available
studies on TCE include lifestage, sex, genetic polymorphisms, race/
ethnicity, preexisting health status, lifestyle factors, and nutrition
status. Groups of individuals for which one or several of these factors
apply may be considered PESS (Ref. 1).
A. ECEL Value of 0.0011 ppm Based on Developmental Toxicity (Proposed)
Because TSCA section 6(c)(2)(B) directs EPA to factor in, to the
extent practicable, the health effects of TCE under TSCA section
6(c)(2)(A), TSCA section 6(c) thereby provides EPA with the flexibility
to tailor the regulatory restrictions to account for particular health
effects identified in the underlying risk evaluation. With this
consideration, EPA found that, in some cases, a regulatory option that
could reduce exposures such that they would achieve the benchmark
margin of exposure for the most sensitive non-cancer endpoint
(developmental toxicity) would address any risk for other non-cancer
endpoints. Older pregnant workers and ONUs, who may be especially
susceptible to TCE- induced cardiac defects in their developing fetus,
are classified as a PESS, and the associated POD and risk estimates
were included in the 2020 Risk Evaluation in consideration of PESS
groups. EPA has carefully considered the health effects of TCE on
pregnant workers and ONUs as part of the Agency's development of
proposed requirements that would be applicable to certain occupational
conditions of use of TCE. In order for this rulemaking to appropriately
address risk to all workers and ONUs exposed to TCE through the
occupational conditions of use for which EPA is proposing an ECEL
associated with a WCPP, EPA has factored in consideration of additional
health effects applicable to PESS, including older pregnant workers and
ONUs (the group identified as most susceptible to fetal cardiac
defects) pursuant to TSCA section 6(c)(2), and is proposing an ECEL
value of 0.0011 ppm based on developmental toxicity (Ref. 13).
In the risk characterization section of the 2020 Risk Evaluation
for TCE, EPA acknowledged that fetal cardiac defects are an acute, non-
cancer endpoint of concern for older pregnant women, while also
acknowledging uncertainty surrounding the use of this endpoint to
inform the determination of whether TCE presents unreasonable risk of
injury to health for all affected human populations. In the 2020 Risk
Evaluation for TCE, EPA presented the Agency's findings with respect to
different endpoints and characterized the immunotoxicity endpoints as
the ``best overall'' non-cancer endpoints for use in the risk
conclusions and risk determination. The endpoints were characterized in
this way precisely because of the quantitative uncertainties
surrounding the use of the fetal cardiac defects endpoint and other
considerations. Further, as noted in Unit II.D.1., EPA has received
numerous comments on EPA's 2020 TSCA Risk Evaluation policy choice
regarding endpoint selection that have raised concerns pertaining to
political interference and scientific integrity, among other issues.
Among the non-cancer adverse health effects, the drivers for EPA's
whole chemical unreasonable risk determination for TCE under TSCA were
identified as immunotoxicity, acute immunosuppression, and chronic
autoimmunity from inhalation and dermal exposures (Ref. 2). EPA
received significant feedback on this aspect of the 2020 Risk
Evaluation for TCE, including focused attention on this issue from the
SACC and public commenters reacting to the draft Risk Evaluation for
TCE (Ref. 42). Moreover, based on the discussion included in the peer
review report of the 2020 Risk Evaluation, EPA also concluded that
reasonable scientists would not disallow the use of the fetal cardiac
defects studies, and that therefore other EPA program reliance on the
fetal cardiac defects endpoint is scientifically valid (e.g., IRIS).
The 2020 Risk Evaluation for TCE identified the developmental
toxicity endpoint of fetal cardiac defects, which presents a lower POD
than the immunotoxicity endpoints. The magnitude of the unreasonable
risk from exposures to TCE would have been greater had the Agency
relied upon the developmental toxicity endpoint (Ref. 1). Specifically,
EPA identified the risk of fetal cardiac defects most strongly
associated with offspring of older mothers, and therefore included risk
estimates for fetal cardiac defects that account for susceptible
mothers and their offspring in addition to PESS groups with other
susceptibilities (e.g., diabetes, infection status, drug exposure,
stress, and metabolic sensitivity due to increased enzymatic activity
of cytochrome P450 2E1 (CYP2E1) (Ref. 1).
EPA developed the ECEL for the most sensitive health endpoint
(developmental toxicity) in support of risk management efforts on TCE
under TSCA, to identify that ambient exposures that are kept at or
below the 8-hour ECEL of 0.0011 ppm would protect against risk of
injury to health due to fetal cardiac defects, if those levels can be
achieved. In addition, EPA expects that at the acute non-cancer ECEL of
0.0011 ppm, any potentially exposed person in the workplace would be
protected against other non-cancer effects resulting from occupational
exposures, as well as excess risk of cancer (Ref. 13). EPA expects that
if a facility were able to meet the ECEL (0.0011 ppm) requirement
associated with the WCPP under the proposed regulatory action outlined
in Unit V.A.2., it would protect PESS during the phaseout period before
the full prohibition.
B. ECEL Value of 0.0040 ppm Based on Immunotoxicity (Primary
Alternative)
In other risk management actions under TSCA section 6, EPA has
proposed basing its worker protection requirements, such as an ECEL, on
a single acute or chronic exposure endpoint that provided the basis for
the unreasonable risk determination (Ref. 40). While EPA is proposing a
different basis for the ECEL for the WCPP for TCE (0.0011 ppm) (to
protect a sensitive PESS), EPA recognizes that among the non-cancer
adverse health effects of TCE, the drivers for EPA's whole chemical
unreasonable risk determination for TCE under TSCA were identified as
immunotoxicity, namely acute immunosuppression and chronic autoimmunity
from inhalation and dermal exposures (Ref. 2). For this reason, the
primary alternative regulatory action provided by EPA includes a WCPP
with a different ECEL (0.0040 ppm), based on the endpoint that drives
the unreasonable risk. As described in more detail in Unit V.B.2.,
reducing exposures to or below the ECEL of 0.0040 ppm would address
that component of the unreasonable risk of injury to health from TCE
that is driven by inhalation exposures in an occupational setting
(Refs. 1, 14). If ambient exposures are kept at or below the 8-hour
ECEL of 0.0040 ppm, EPA expects that workers and ONUs would be
protected against not only the chronic non-cancer effects for
autoimmunity described in this unit, but also effects resulting from
acute non-cancer exposure (immunosuppression) and cancer.
As described in Unit V.A.2., for the ECEL value of 0.0011 ppm,
proposed as
[[Page 74732]]
part of the WCPP, EPA requests comment on the use of TSCA section
6(c)(2) to tailor the risk management actions where necessary to
protect PESS. Also, as described in Unit V.B.2., EPA is requesting
comment on the use of the ECEL value of 0.0040 ppm in the WCPP in the
alternative regulatory action. Specifically, EPA is requesting comment
on the selection of the fetal cardiac defects endpoint for the ECEL of
0.0011 ppm in the proposed regulatory action, rather than the
immunotoxicity endpoint on which the unreasonable risk determination is
based, which would result in an ECEL of 0.0040 ppm. EPA is also
requesting comment on additional ways to protect workers and ONUs who
are or may become pregnant.
V. Proposed and Primary Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
TCE will no longer present an unreasonable risk of injury to health. In
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost effectiveness of the proposed
regulatory action and one or more primary alternative regulatory
actions. In the case of TCE, the proposed regulatory action is
described in Unit V.A. and the primary alternative regulatory action
considered is described in Unit V.B. An overview of the proposed
regulatory action and primary alternative regulatory action for each
condition of use is in Unit V.C. The rationale for the proposed and
primary alternative regulatory actions and associated compliance
timeframes are discussed in this unit and in more detail in Unit VI.A.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to: Prohibit all
manufacture (including import), processing, distribution in commerce,
and industrial and commercial use of TCE for all uses (including all
consumer uses), with longer timeframes and workplace controls for
certain processing and industrial and commercial uses (including
proposed phaseouts and TSCA section 6(g) exemptions); prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works with a 50-year TSCA section 6(g)
exemption for cleanup projects; and establish recordkeeping and
downstream notifications requirements. Prohibitions on manufacturing
(including import) and processing, including staggered implementation
timeframes to account for the supply chain, are outlined in Unit
V.A.1.a.; prohibitions on industrial and commercial uses and
distribution in commerce are outlined in Unit V.A.1.b.; and
prohibitions related to consumer uses are outlined in Unit V.A.1.c.
EPA is proposing longer compliance timeframes (with workplace
controls) for prohibitions on certain conditions of use. The timeframe
for a prohibition or phaseout under TSCA section 6(d) must begin as
soon as practicable, but not later than 5 years, with the full
implementation of the prohibition or phase-out requirements occurring
as soon as practicable and providing for a reasonable transition
period. For a TSCA section 6(g) exemption for a specific condition of
use, EPA must establish a time limit as reasonable on a case-by-case
basis as long as the exemption meets the criteria under TSCA section
6(g)(1). First, EPA is proposing to prohibit the manufacturing
(including import) and processing of TCE as an intermediate for the
manufacture of HFC-134a through an 8.5-year phaseout, as outlined in
Unit V.A.1.d. Second, EPA is proposing a 10-year phaseout for the
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production for Federal agencies and their contractors,
conditioned on a final pre-launch test within 5 years of rocket booster
nozzles that have been produced without using TCE, as outlined in Unit
V.A.1.e. Third, EPA is proposing a time-limited exemption for 10 years
under a TSCA section 6(g) exemption related to prohibitions on the
industrial and commercial use of TCE as a processing aid for battery
separator manufacturing, as outlined in Unit V.A.3.b.i. Fourth, EPA is
proposing a time-limited exemption for 10 years under a TSCA section
6(g) exemption related to prohibitions on industrial uses of TCE for
DoD vessel requirements for potting, bonding and sealing compounds, and
bonding and cleaning requirements for naval combat systems, radars,
sensors, equipment, and fabrication and prototyping processes, as
outlined in Unit V.A.3.b.ii. Fifth, EPA is proposing a time-limited
exemption for 50 years under a TSCA section 6(g) exemption related to
prohibitions on the industrial and commercial use of TCE in laboratory
use for essential laboratory activities and some research and
development activities, as outlined in Unit V.A.3.b.iii. Sixth, EPA is
proposing a time-limited exemption for 7 years under a TSCA section
6(g) exemption related to prohibitions on the industrial and commercial
use of TCE as a solvent in closed loop vapor degreasing necessary for
human-rated rocket engine cleaning by NASA and its contractors.
Seventh, EPA is proposing a time-limited exemption for 10 years under a
TSCA section 6(g) exemption for emergency industrial and commercial use
of TCE for specific conditions of use which are critical or essential
in furtherance of NASA's mission and for which no technically and
economically safer alternative is available. Where conditions of use
would be prohibited under timeframes longer than one year, EPA's
proposal aims to align with elements of existing OSHA regulations and
industrial hygiene best practices to the extent possible by
implementing a Workplace Chemical Protection Program (WCPP). The WCPP
includes requirements for an inhalation exposure limit and glove
requirements to limit exposure to TCE until the prohibitions take
effect, as outlined in Unit V.A.2. Lastly, EPA is proposing to prohibit
certain disposal of TCE (specifically, the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works), as outlined in Unit V.A.1.f., with a time limited 50-
year exemption for cleanup projects as outlined in Unit V.A.3.b.iv; and
establish recordkeeping and downstream notification requirements, as
outlined in Unit V.A.4. EPA requests comment on the applicability to
the private sector of proposed regulatory actions pertaining
specifically to Federal agencies, namely industrial uses for DoD vessel
requirements and closed-loop batch vapor degreasing for rayon fabric
scouring for rocket booster nozzle production. EPA requests comment on
the extent to which the private sector would be affected by a
prohibition on these uses.
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce,
Use, and Disposal
a. Prohibitions on Manufacturing (Including Import) and Processing of
TCE
EPA is proposing to prohibit the manufacturing (including import)
and processing of TCE based on the unreasonable risk to workers and
ONUs driven by these conditions of use (Ref. 2). As the manufacture and
processing of TCE presents and unreasonable risk to health in the
United States, the manufacture and processing of TCE for export would
also be prohibited in accordance with TSCA section 12(a)(2).
As discussed in Units III.B.3. and VI.A., based on the Agency's
consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty
[[Page 74733]]
relative to the feasibility of exposure reduction to sufficiently
address the unreasonable risk across the broad range of occupational
environments and activities that occur in manufacturing (including
import) and processing conditions of use, and the irreversible health
effects associated with TCE exposures, EPA has determined that
prohibition is the best way to address the unreasonable risk.
EPA is proposing that the prohibitions on manufacturing (including
import) and processing of TCE would follow a staggered schedule, due to
supply chain considerations. EPA proposes that the compliance dates for
the proposed prohibitions described in this unit, such that the
requirements would come into effect in 90 days (3 months) for
manufacturers and in 180 days (6 months) for processors, with different
timeframes related to specific conditions of use. Specifically, for
processing TCE as a reactant/intermediate, EPA is proposing that the
compliance dates for the proposed prohibitions described in this unit
would come into effect in 1.5 years for manufacturers and 2 years for
processors. There are additional exceptions from the prohibition for
the manufacturing and processing associated with certain processing and
industrial and commercial uses, including those described later in this
unit (for which EPA is proposing longer compliance timeframes,
including phaseouts (see Units V.A.1.b., d., and e.) or time-limited
exemptions under TSCA section 6(g) (see Unit V.A.3.b.)). The rationale
for longer timeframes for certain conditions of use is described in
Unit VI.A.1.
b. Prohibitions on Industrial and Commercial Use and Distribution in
Commerce of TCE
EPA is proposing to prohibit the industrial and commercial use of
TCE, based on the unreasonable risk to workers and ONUs driven by these
conditions of use (Ref. 2). As discussed in Units III.B.3. and VI.A.,
based on consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty relative to the feasibility of exposure reduction to
sufficiently address the unreasonable risk across the broad range of
work environments and activities represented by industrial and
commercial uses of TCE, and the irreversible health effects associated
with TCE exposures, EPA has determined that prohibition is the best way
to address the unreasonable risk. However, in consideration of the
challenges several sectors may encounter in adopting alternatives to
TCE, EPA is proposing longer compliance timeframes for certain uses
under this prohibition.
EPA is proposing compliance dates for the proposed prohibitions
that would come into effect for most industrial and commercial users
270 days after the publication date of the final rule. However, EPA is
proposing longer compliance timeframes under this prohibition for some
industrial and commercial uses and for the associated manufacturing
(including import), processing, and distribution in commerce.
Specifically, for two batch vapor degreasing conditions of use (open-
top and closed-loop), EPA is proposing that the compliance dates for
the proposed prohibitions described in this unit would come into effect
in 180 days for manufacturers, in 270 days (9 months) for processors,
specifically for processing into a formulation and for recycling, and
in 1 year for the industrial and commercial uses of TCE in open-top and
closed-loop batch vapor degreasers (see Unit III.B.1.c.i. and ii. for
descriptions of these conditions of use and Unit VI.A.1. for a
rationale for the slightly longer timeframe). For a sub-set of the
closed-loop batch vapor degreasing condition of use (industrial and
commercial use of TCE as a solvent for closed-loop batch vapor
degreasing for rayon fabric scouring for end use in rocket booster
nozzle production for Federal agencies and their contractors) EPA is
proposing that the compliance dates for the proposed prohibitions
described in this unit would come into effect in five or 10 years for
manufacturers, processors, distributors, and industrial and commercial
users, depending on whether the conditions of the phaseout are met (see
Unit V.A.1.e. for a description of the conditions of this proposed
exemption, and Unit VI.A.1. for the rationale for this timeframe).
Also, EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit would come into effect for
commercial use of TCE as a processing aid in 1.5 years for
manufacturers, in 2 years for processors, and in 2 years for industrial
and commercial use of TCE in: processing aid in process solvent used in
battery manufacture; process solvent used in polymer fiber spinning,
fluoroelastomer manufacture and Alcantara manufacture; extraction
solvent used in caprolactam manufacture; and precipitant used in beta-
cyclodextrin manufacture (see Unit III.B.1.c.xvi. for a description of
this condition of use and Unit V.A.1. for a rationale for the different
timeframe).
To aid with implementation of the compliance dates for the proposed
prohibitions on manufacturing, processing, and industrial and
commercial use of TCE, and ensure that those prohibitions effectively
address the unreasonable risk identified, EPA is also proposing
prohibitions on distribution in commerce of TCE. Generally, for most
conditions of use EPA is proposing that the compliance date for the
proposed prohibition on distributors in commerce of TCE would come into
effect 180 days (6 months) following publication of the final rule. In
instances where EPA is proposing a prohibition on manufacturing and
processing TCE for a particular industrial and commercial use that is
later than 180 days after publication of the final rule, the compliance
date for the proposed prohibition on distribution in commerce would be
the same as the compliance date of the proposed prohibition on
manufacturing and processing TCE.
As noted in Unit III.B.1.f., this proposal does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the
impacts, if any, that a prohibition on the processing of TCE into a
formulation, mixture or reaction product in other chemical products and
preparations, or other aspects of this proposal, may have on the
production and availability of any pesticide or other substance
excluded from the TSCA definition of ``chemical substance.'' EPA also
requests comment on whether it should consider a de minimis level of
TCE in formulations to account for impurities (e.g., 0.1% or 0.5%) when
finalizing the prohibitions described in this unit, and, if so,
information on and rationale for any level that should be considered de
minimis.
When proposing the compliance dates described in this unit as
required under TSCA section 6(d), EPA considered irreversible health
effects associated with TCE exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
However, EPA requests comment on whether additional time is needed, for
example, for products to clear the channels of trade, or for
implementing the use of substitutes; comments should include
documentation such as the specific use of the chemical throughout the
supply chain; concrete steps taken to identify, test, and qualify
substitutes for those uses (including details on the substitutes tested
and the specific
[[Page 74734]]
certifications that would require updating); and estimates of the time
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply. EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
c. Prohibitions of Manufacturing, Processing, and Distribution in
Commerce of TCE for Consumer Use
The consumer uses evaluated in the 2020 Risk Evaluation for TCE
constitute all known, intended, and reasonably foreseen consumer uses
of TCE. As described in this unit, EPA is proposing to prohibit all
manufacturing (including import) and processing of TCE to address the
unreasonable risk to workers and ONUs driven by those conditions of use
(Ref. 2). EPA does not believe any delays are necessary for
prohibitions on manufacture (including import), processing, or
distribution in commerce of TCE for consumer use. EPA notes that not
only did all but one of the 24 consumer uses of TCE evaluated in the
2020 Risk Evaluation for TCE support the unreasonable risk
determination for TCE (Refs. 1, 2), but also the manufacture (including
import) and processing of TCE for consumer uses generally supports
EPA's unreasonable risk determination for workers and ONUs, as further
discussed in Unit V.A. For these reasons, and based on considerations
of the severity of the hazards of TCE, EPA is proposing to prohibit the
manufacturing (including import), processing, and distribution in
commerce of TCE for all uses, which includes all consumer uses.
EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit relevant to consumer uses would
come into effect for manufacturers 90 days (3 months) and for
processors 180 days (6 months) after the publication date of the final
rule in the Federal Register. EPA is also proposing prohibitions on
distribution in commerce of TCE for consumer uses to aid with effective
implementation of the prohibitions on manufacturing and processing, and
to address the unreasonable risk to consumers and bystanders. EPA
proposes that the compliance dates for the proposed prohibition on
distribution in commerce of TCE for consumer use would come into effect
180 days (6 months) after the publication date of the rule in the
Federal Register. EPA considered the risk of irreversible health
effects associated with TCE exposure when proposing these compliance
dates. EPA has no reasonably available information indicating these
proposed compliance dates are not practicable for the activities that
would be prohibited or that additional time is needed for products to
clear the channels of trade. However, EPA requests comment on whether
additional time is needed, for example, for products to clear the
channels of trade, or for implementing the use of substitutes; comments
should include the considerations described in Unit V.A.1.b. EPA may
finalize significantly shorter or longer compliance timeframes based on
consideration of public comments.
EPA also requests comment on whether it should consider a de
minimis level of TCE in formulations to account for impurities (e.g.,
0.1% or 0.5%) when finalizing the prohibitions described in this unit,
and, if so, information on and rationale for any level that should be
considered de minimis.
d. Phaseout of TCE for Processing as an Intermediate for the
Manufacture of HFC-134a.
As described in this unit, EPA is proposing a longer phaseout
timeframe for the manufacturing (including import) and processing of
TCE as an intermediate for the manufacture of HFC-134a (1,1,1,2-
Tetrafluroethane; CAS Number 811-97-2). EPA is proposing an 8.5-year
phaseout subject to the requirements discussed in this unit. All other
processing of TCE as a reactant/intermediate would be subject to the
proposed prohibitions described in Unit V.A.1.b. EPA is proposing to
require a phaseout for processing of TCE as an intermediate for the
manufacture of HFC-134a, which EPA expects would begin at the final
rule's effective date and end 8.5 years after the publication of the
final rule. Associated with this phaseout, EPA would require the
establishment of the TCE WCPP, outlined in Unit V.A.2., within 6 months
after publication of the final rule, as workplace protections during
the period of the phaseout. To set the phaseout volumes, EPA would
require any facility processing TCE as an intermediate to manufacture
HFC-134a in the United States to establish a baseline of the annual
quantity of TCE processed by the facility as a feedstock to manufacture
HFC-134a. EPA is proposing to require that within 6 months after the
publication of the final rule the manufacturer could use the average of
any 12 consecutive months in the 36 months preceding the publication of
the final rule to calculate their baseline, based on records that
demonstrate how the baseline annual volume was calculated. Following
the establishment of a baseline volume, the regulated entity would then
be required to implement a 4-step phaseout process; specifically, the
phaseout would be a 25 percent reduction from the baseline volume every
2 years as follows: (1) 2.5 years after the publication of the final
rule each manufacturer of HFC-134a who processes TCE as an intermediate
would not be permitted to process TCE as an intermediate at an annual
volume greater than 75 percent of the baseline; (2) 4.5 years after the
publication of the final rule each manufacturer of HFC-134a who
processes TCE as an intermediate would not be permitted to process TCE
as an intermediate at an annual volume greater than 50 percent of the
baseline; (3) 6.5 years after the publication of the final rule each
manufacturer of HFC-134a who processes TCE as an intermediate would not
be permitted to process TCE as an intermediate at an annual volume
greater than 25 percent of the baseline; and (4) 8.5 years after the
publication of the final rule each manufacturer of HFC-134a would be
prohibited from processing TCE as an intermediate.
EPA notes that the prohibition for manufacture (including
importing), processing, and distribution in commerce of TCE for this
condition of use would occur after 8.5 years to account for
availability of TCE through the supply chain during the period of the
phaseout of processing of TCE as an intermediate for the manufacture of
HFC-134a. This timeframe would be longer than the prohibitions on
manufacturing and processing TCE described in Unit V.A.1.a.
EPA is also proposing to require regulated entities to keep records
of the annual quantity of TCE purchased and processed from the year
2023 until the termination of all processing of TCE as an intermediate.
EPA requests comment on whether additional recordkeeping requirements
are warranted or additional time would be needed, for example, to begin
the phaseout of processing TCE as an intermediate for the manufacture
of HFC-134a.
EPA notes, per TSCA section 6(c)(2)(C), that although the use of
TCE to produce HFC-134a would be prohibited eventually due to
unreasonable risk, the use of PCE to produce HFC-134a is proposed to
continue in perpetuity under a WCPP (88 FR 39652, July 16, 2023). As
such, the refrigerant would remain available while protecting workers.
[[Page 74735]]
e. Phaseout of TCE in industrial and Commercial Use as a Solvent for
Closed-Loop Batch Vapor Degreasing for Rayon Fabric Scouring for Rocket
Booster Nozzle Production
EPA is proposing a longer phaseout timeframe for industrial and
commercial use as a solvent for closed-loop batch vapor degreasing for
rayon fabric scouring for end use in rocket booster nozzle production
by Federal agencies and their contractors. This is the industrial and
commercial use of TCE in a closed-loop batch vapor degreaser to clean,
or `scour,' rayon fabric to remove sizing (i.e., protective filler or
glaze on textiles), oils, and other contaminants from the rayon fabric
that is used to line the inside of rocket booster nozzles; the
degreasing is essential in preparing the rayon fabric before a
carbonization process ahead of being used in the rocket booster
nozzles. If contaminants are not removed properly from the rayon, the
result could include nozzle failure (Ref. 43). More information on this
use and the rationale for the phaseout are in Unit VI.A.1. For this
sub-set of the vapor degreasing condition of use, when conducted by
Federal agencies and their contractors, EPA is proposing a 10-year
phaseout subject to the requirements discussed in this unit. (All other
industrial and commercial use of TCE as a solvent for vapor degreasing,
including use of TCE in closed-loop batch vapor degreasing of other
parts or materials, would be subject to the proposed prohibitions
described in Unit V.A.1.b.). For the phaseout, EPA is proposing that
within 5 years of the publication date of the final rule the Federal
agency that is the end user of the rayon fabric for rocket booster
nozzle production (e.g., the U.S. Department of Defense (DOD) or the
NASA) would need to conduct a final pre-launch test of rocket boosters
without using TCE; this test is further discussed in Unit VI.A.1.a. By
10 years from the publication date of the final rule, the phaseout
would be complete and industrial and commercial use of TCE as a solvent
for closed-loop batch vapor degreasing, including for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, would be prohibited. As part of this
phaseout, EPA would require a TCE WCPP, described in Unit V.A.2.,
within 6 months after publication of the final rule, as workplace
protections during the period of the phaseout until the full
prohibition takes effect. Additionally, this phaseout would include
recordkeeping requirements beginning 6 months after publication of the
final rule related to the rayon fabric scouring for end use in rocket
booster nozzle production. The entity must have records indicating that
their closed-loop batch vapor degreasing with TCE is for rayon fabric
scouring for end use in rocket booster nozzle production for a Federal
agency or a contractor. Beginning 5 years after the publication of the
final rule, to continue to use TCE for closed-loop batch vapor
degreasing for this specific use, the user must have records from a
Federal agency indicating that a final pre-launch test for the rayon
fabric scouring has been conducted with an alternative chemical or
process.
f. Prohibition of Disposal of TCE to Industrial Pre-Treatment,
Industrial Treatment, or Publicly Owned Treatment Works
Due to the unreasonable risk to workers exposed to TCE while
performing industrial wastewater pre-treatment and treatment, EPA is
proposing to prohibit this mode of disposal of TCE (i.e., generated
wastewater that contains TCE that is collected on site or transported
to a third party site, and includes the mixing of TCE with wastewater
and the discharge of TCE-contaminated wastewater) (description of
disposal for the purposes of this rulemaking is in Unit III.B.2.d.).
TSCA section 6(a) provides EPA the authority to prohibit or otherwise
regulate any manner or method of disposal of a chemical substance by
its manufacturer, processor, or any other person who uses or disposes
of it for commercial purposes. EPA is proposing to prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works. Facilities generating solid waste with
TCE concentrations above the RCRA regulatory level of 0.5 mg/L using
the Toxicity Characteristic Leaching Procedure (see 40 CFR 261.24)
would need to manage TCE separately from wastewater and dispose of TCE
through a different disposal mechanism, due to the prohibition in RCRA
against using dilution as a substitute for appropriate treatment (see
40 CFR 268.3), while following the appropriate RCRA requirements when
handling waste containing TCE. Dilution of hazardous waste (including
by mixing it with wastewater) as a substitution for adequate treatment
is prohibited under RCRA (see 40 CFR 268.3).
EPA is proposing that the compliance date for the proposed
prohibition described in this unit would be 270 days (9 months) after
the publication date of the final rule for manufacturers, processors,
distributors, and industrial and commercial users disposing of TCE to
wastewater. EPA has no information indicating that the proposed
compliance dates would not be practicable for purposes of finding an
alternative disposal method, or that additional time would be needed,
for example, for facilities to transition to an alternative disposal
method. EPA's understanding is that only 1 percent of TCE is disposed
of as wastewater. However, EPA requests comment on whether the 270-day
proposed compliance date is practicable, whether additional time is
needed, for example, for a regulated entity to implement a change to
their disposal processes or to transition to alternative disposal
methods, including what those alternative disposal methods would be,
and their cost and feasibility. EPA is also proposing, as described in
Unit V.A.3., a time-limited exemption for 50 years under TSCA section
6(g) for disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purpose of cleanup
projects of TCE-contaminated groundwater and other wastewater.
2. WCPP for Certain Conditions of Use
a. Overview
As described in Unit III.B.3., EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. The TSCA section 6(a) requirements provide EPA the authority
to limit or restrict a number of activities, alone or in combination,
including the manufacture, processing, distribution in commerce,
commercial use, and disposal of the chemical substance. Given this
authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational conditions
of use (e.g., manufacturing, processing, industrial and commercial
use). However, for the reasons described in Unit VI., including the
challenges of reliably reducing exposure below the ECEL and being able
to monitor at the appropriate action level, EPA's proposed requirement
for the TCE WCPP is that owners or operators ensure that no person is
exposed to TCE in excess of the ECEL as an 8-hr TWA to the extent
possible (supported by documentation further described in Unit
V.A.2.d.i.) rather than (as has been proposed in other rules under TSCA
section 6) a requirement that exposures do not exceed the ECEL. Due to
these
[[Page 74736]]
challenges, as well as the severity of the hazard from TCE, EPA notes
that long-term implementation of the WCPP would not be a feasible means
of addressing TCE unreasonable risk and thus EPA believes that
prohibition of the COUs would ultimately be necessary to address the
unreasonable risk. Furthermore, when selecting among proposed
prohibitions and other restrictions that would apply to those
occupational conditions of use, EPA has also factored in considerations
relating to health effects on PESS, including on older pregnant workers
and ONUs (the group identified as most susceptible to fetal cardiac
defects), further discussed in Units V.A.1. and VI.A. For the time
period before which a prohibition would become effective, for several
conditions of use, EPA is proposing a TCE WCPP to address to the extent
possible the unreasonable risk. The WCPP would include a TCE ECEL of
0.0011 ppm, the associated implementation requirements, and may include
other components, such as dermal protection, as described in this unit.
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, ONUs, employees, independent
contractors, employers, and all other persons in the work area who may
be exposed to TCE under the conditions of use for which a WCPP would
apply. EPA's intention is to require a comprehensive WCPP that would
put additional protections in place to reduce the unreasonable risk
from TCE to potentially exposed persons directly handling the chemical
or in the area where the chemical is being used, until the prohibition
compliance date.
Similarly, the risk evaluation for TCE did not distinguish between
employers, contractors, or other legal entities or businesses that
manufacture, process, distribute in commerce, use, or dispose of TCE.
EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use is occurring and TCE is present. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace.
An ECEL is a risk-based inhalation exposure threshold. The ECEL
would be accompanied by monitoring, training, recordkeeping, and other
requirements so that exposures to TCE are reduced to the extent
possible (as supported by documentation further described in Unit
V.A.2.d.i.). With an ECEL, the WCPP provides the least uncertainty
regarding the protection afforded to workers, requires regulated
entities to consider more protective controls in the hierarchy, and
lessens the burden on workers. Under this proposal, regulated entities
would have some flexibility in the manner in which they implement
modifications, within certain parameters outlined in this unit, or
otherwise aim to prevent exceedances of the ECEL at their facilities.
Therefore, EPA generally refers to the ECEL and ancillary requirements
as a non-prescriptive approach. This unit includes a summary of the
proposed TCE WCPP, including a description of the proposed ECEL of
0.0011 ppm; proposed implementation requirements and an EPA ECEL action
level; proposed monitoring requirements; a description of potential
exposure controls, which consider the hierarchy of controls;
information that may be used to inform respirator selection; proposed
glove requirements; and additional requirements proposed for
recordkeeping, and worker training, participation, and notification.
This unit also describes proposed compliance timeframes for these
proposed requirements.
EPA does not believe that long-term implementation of the WCPP
would be a feasible means of addressing unreasonable risk indefinitely;
thus prohibition of the use of TCE for affected COUs is ultimately
necessary to address the risk so that it is no longer unreasonable, due
to the severity of the hazard, the magnitude of the exposures, and the
challenges of consistently reducing exposures below the low TCE ECEL in
a way that is consistent with the hierarchy of controls, further
described in Unit VI.A.1. However, for the conditions of use which
would continue for longer than a year, as well as during the proposed
TSCA section 6(g) time-limited exemption, EPA is proposing the WCPP to
reduce to the extent possible the unreasonable risk from TCE during the
time period before compliance dates for the proposed prohibition would
come into effect. EPA is not proposing the WCPP for uses that would be
prohibited within 1 year from the effective date of the final rule.
Based on reasonably available information, EPA expects that the ECEL is
likely to be exceeded and that compliance with the WCPP would require
large investments into PPE and engineering controls at facilities. For
this reason, EPA's proposal aims to encourage facilities engaged in
uses that would be prohibited within a year from finalization to focus
their resources on the transition to alternatives to TCE. EPA is
requesting comment on how entities could demonstrate that they are
reducing exposures to the extent possible (including considerations for
technological feasibility) and is also requesting comment on whether
EPA's requirement should be that entities ensure that exposures are
reduced below the ECEL, rather than to the extent possible or lowest
achievable level described further in Unit V.A.2.d.i. Should regulated
entities be able to consistently demonstrate compliance with an ECEL
through effective controls, EPA requests comments regarding replacing
the proposed prohibitions with compliance with the WCPP.
b. Existing Chemical Exposure Limit (ECEL)
i. ECEL and ECEL Action Level
To reduce exposures in the workplace and eliminate the unreasonable
risk of injury to health resulting from inhalation exposures to TCE
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for TCE, EPA is proposing an ECEL of 0.0011 parts per
million (ppm) (0.0059 mg/m\3\) for inhalation exposures to TCE as an 8-
hour TWA. As described in Unit IV.A., this ECEL is based on
developmental toxicity, the most sensitive acute and chronic non-cancer
health endpoint, specifically calculated based on the occupational
acute, non-cancer human equivalent concentration (HEC) for fetal
cardiac defects (Ref. 13). EPA is proposing to establish requirements
for an ECEL as part of the WCPP until the prohibition compliance date
for certain conditions of use that would be permitted to continue for
longer than a year after the effective date of the final rule,
including the conditions of use described in Unit V.A.1.a., as well as
the conditions of use that would be subject to the phaseout described
in Unit V.A.1.d. and the TSCA section 6(g) exemptions described in Unit
V.A.3.
Each owner or operator of a workplace where these conditions of use
occur would be responsible for compliance with the ECEL and the
associated requirements. EPA's description for how the requirements
related to an ECEL would reduce the unreasonable risk resulting from
inhalation exposures and the rationale for this regulatory approach is
outlined in Units III.B.3. and V.A.
In order for this rulemaking to appropriately reduce risk to all
potentially exposed persons that may be exposed to TCE through the
occupational conditions of use for which EPA is proposing compliance
with the WCPP as a protection measure,
[[Page 74737]]
EPA has factored in consideration of additional health effects
applicable to PESS pursuant to TSCA section 6(c)(2), outlined in Unit
VI.A. EPA developed the ECEL for the most sensitive health endpoint
(fetal cardiac defects) in support of risk management efforts on TCE
under TSCA, to identify at what level ambient exposures would protect
against unreasonable risk of injury to health due to fetal cardiac
defects. The level identified is an 8-hour ECEL of 0.0011 ppm, which,
when possible to achieve, is the concentration at which an adult human
would be unlikely to experience the specified adverse effects if
exposed during a working lifetime, including susceptible
subpopulations. In addition, at the acute non-cancer ECEL of 0.0011
ppm, any potentially exposed person in the workplace would be protected
against other non-cancer effects resulting from occupational exposures,
as well as excess risk of cancer (Ref. 13). However, as noted in Unit
IV., EPA does not believe that long-term implementation of the WCPP
with this low ECEL would be a feasible means of addressing unreasonable
risk indefinitely, and EPA is uncertain if the ECEL and associated
action level can be met reliably as discussed further in Unit VI.A.1.
EPA invites comment on the existing practices (e.g., engineering
controls, administrative controls, PPE) involving TCE for the
conditions of use listed in Unit V.A.1.a., Unit V.A.1.d., and Unit
V.A.3., whether activities may take place in closed systems, and the
degree to which users of TCE in these sectors could successfully
implement the WCPP, including an ECEL of 0.0011 ppm for TCE, dermal
protection, and ancillary requirements described in Unit IV.A. EPA
acknowledges that reducing and accurately detecting exposures from the
current OSHA PEL of 100 ppm to the proposed TSCA ECEL of 0.0011 ppm
would be very difficult. EPA also invites comment on the potential to
develop future technologies (e.g., engineering controls, administrative
controls, PPE) involving TCE for the conditions of use listed in Unit
V.A.1.a., Unit V.A.1.d., and Unit V.A.3., that would facilitate
successful implementation of the WCPP, including an ECEL of 0.0011 ppm
for TCE, dermal protection, and ancillary requirements described in
Unit IV.A. EPA is also requesting comment on the feasibility of
controlling worker exposures to TCE at or below the proposed ECEL, and
the accuracy of measurements at this level. This is important for
determining whether there are realistic and effective exposure controls
that can be used by industry for effectively controlling exposures to
levels at or below the ECEL. To the extent time is needed to ensure
methods are available to accurately measure TCE at or below the ECEL,
EPA is requesting comment on whether a phased approach to an ECEL is
desirable; that is, an approach that would establish a timeframe for
meeting the ECEL as well as a shorter timeframe for meeting a
concentration level higher than the ECEL (but lower than the PEL) that
is currently considered achievable. EPA welcomes data or information to
demonstrate that meeting the proposed ECEL over a sustained period of
time would be feasible and measurable.
EPA is also proposing to establish an ECEL action level of 0.00055
ppm as an 8-hour TWA for TCE. Air concentrations at or above the action
level would trigger more frequent periodic monitoring of exposures to
TCE, as described in this unit. EPA is proposing to adopt the action
level approach in implementing the TSCA ECEL, similar to the action
level approach used by OSHA in the implementation of OSHA standards,
although the values differ due to differing statutory authorities. As
explained by OSHA, due to the variable nature of employee exposures,
compliance with an action level provides employers with greater
assurance that their employees will not be exposed to concentrations
above the PELs (Ref. 44). EPA agrees with this reasoning and, like
OSHA, expects the inclusion of an ECEL action level will stimulate
innovation within industry to reduce exposures to levels below the
action level. Therefore, EPA has identified a need for an action level
for TCE and is proposing a level that would be half the 8-hour ECEL,
which is in alignment with the precedented approach established under
most OSHA standards. EPA is soliciting comment regarding an ECEL action
level that is half the ECEL and any associated provisions related to
the ECEL action level when the ECEL is significantly lower than the
OSHA PEL. EPA is also soliciting comment on whether the ECEL action
level should be aligned with OSHA PEL action levels (typically set at
half the limit) due to the fact that PEL accounts for technological
feasibility and the action level is not necessarily designed to be
health protective. Since exposure below the ECEL would be health
protective, EPA seeks comment on whether the action level should be set
at a different value closer to the ECEL that would trigger increased
monitoring to ensure that the ECEL is not exceeded, and whether
technological feasibility should be considered in setting the action
level.
In summary, EPA is proposing that each owner or operator of a
workplace subject to compliance with the TCE WCPP must ensure that no
person is exposed to an airborne concentration of TCE in excess of
0.0011 ppm (0.0059 mg/m3) as an 8-hour TWA (ECEL), with an action level
identified as 0.00055 ppm (0.0029 mg/m3) (ECEL action level) to the
extent possible, as supported by documentation further described in
Unit V.A.2.d.i.). For conditions of use for which the requirements to
comply with the WCPP are being proposed, EPA expects that measurement
of extremely low-ppm levels of TCE may present challenges to the
regulated community. During the development of the TCE ECEL, EPA
conducted a search to identify relevant NIOSH, OSHA, and EPA analytical
methods that may be used to monitor for the presence of TCE in indoor
air. While EPA identified analytical methods that may be used, based on
information from stakeholders, EPA also recognizes that it may be
difficult to operationalize routine use of these methods for detection
at the low levels needed for the TCE ECEL and ECEL action level.
Specifically, these methods may be challenging to use for personal
breathing zone monitoring to detect lower air concentration levels at
the ECEL and ECEL action level based on the developmental toxicity
endpoint for fetal cardiac defects (Ref. 13). However, EPA acknowledges
that in recent years commercial passive air sampling devices have
improved and may be available for use for personal air sampling at
extremely low-ppm levels of TCE (Ref. 45). EPA is requesting comment on
personal air sampling devices that are capable of detecting indoor air
TCE concentrations at or below the ECEL action level of 0.00055 ppm
(0.0029 mg/m3) with the requisite precision and accuracy.
EPA acknowledges that the challenge of suitable personal breathing
zone monitoring methods to detect TCE air concentration levels at the
ECEL of 0.0011 ppm and ECEL action level of 0.00055 ppm could cause
difficulty in determining whether a workplace is in compliance with the
ECEL. EPA is therefore requesting comment on whether to require
compliance with an interim exposure level based on the limit of
detection of established analytical methods. This interim level, unlike
the ECEL, would not necessarily eliminate unreasonable risk, but rather
reduce risk to an extent that corresponds to the air concentration that
current analytical methods can reliably measure to and would be the
exposure
[[Page 74738]]
limit during the period in which TCE is still in use until its eventual
prohibition. EPA requests comment on setting such an interim level for
TCE based on a limit of detection that is the lowest limit of detection
using analytical methods developed by OSHA/NIOSH for personal breathing
zone monitoring. More specifically, EPA requests comment on using OSHA
Method 1001, which has a personal breathing zone limit of detection for
TCE of 18 ppb, or 0.018 ppm, to set an interim exposure limit of 0.036
ppm, with an action level of 0.018 ppm (Ref. 46).
Under this approach, EPA would initially establish an exposure
value that would be technically feasible to detect in the near-term,
with a step down to the ECEL at a later date, until the applicable
prohibition would take effect. This approach would significantly reduce
exposures to TCE from the current OSHA PEL of 100 ppm by establishing
an interim exposure value of 0.036 ppm and action level of 0.018 ppm,
until advancements in technologies reliably support measurement at the
ECEL or below. EPA requests comments that provide supported
recommendations for one or more incremental exposure values and
associated timelines for achieving the incremental exposure levels and
the currently proposed ECEL of 0.0011 ppm, and comments that consider
and provide information on the needed advancements in exposure
monitoring methods, analytical methods, and exposure controls,
including expected timelines for developing these capabilities.
The proposed requirements would be applicable to owners and
operators of workplaces where manufacturing (including import),
processing, and industrial and commercial use of TCE would be permitted
to continue more than 1 year after the publication of the final rule.
The proposed requirements would be applicable from the date of
publication of the final rule until the prohibition compliance date for
those conditions of use. However, the proposed requirements of the WCPP
would not be applicable to owners and operators of workplaces where EPA
is proposing to prohibit manufacturing and processing for certain
industrial and commercial use and consumer uses within 1 year of the
effective date of the final rule. The WCPP would also not be applicable
to owners and operators of workplaces where EPA is proposing to
prohibit distribution in commerce or disposal to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
As described further in Unit VI.A.1., EPA believes that long-term
implementation of the WCPP for continued use of TCE is not a feasible
means of addressing unreasonable risk such that prohibition ultimately
would be necessary to address the unreasonable risk.
ii. Monitoring Requirements
Overview. Monitoring requirements are a key component of
implementing EPA's proposed WCPP. Initial monitoring for TCE would be
critical for establishing a baseline of exposure for potentially
exposed persons and for identifying the lowest achievable exposure
level in a facility; similarly, periodic exposure monitoring would
assure that exposures continue to be reduced to the lowest level
achievable so that unreasonable risk of injury is reduced for
potentially exposed persons in the workplace. Periodic exposure
monitoring frequency could change if certain conditions are met, which
are described in this unit. Additionally, in some cases, a change in
workplace conditions with the potential to impact exposure levels would
warrant additional monitoring, which is also described. To ensure
compliance with monitoring activities, EPA proposes exposure monitoring
recordkeeping requirements outlined in this unit.
Initial exposure monitoring. Under the proposed regulation, each
owner or operator of a workplace where any condition of use subject to
a WCPP is occurring would be required to perform initial exposure
monitoring to determine the extent of exposure of potentially exposed
persons to TCE. Initial monitoring would notify owner or operators of
the magnitude of possible exposures, to their potentially exposed
persons with respect to their unique work conditions and environments.
The results of the initial exposure monitoring would be used to help
determine the lowest achievable level in a facility, the frequency of
future periodic monitoring, whether additional exposure controls are
necessary (such as engineering controls, administrative controls, and/
or respiratory protection), and whether the owner or operator would
need to demarcate a regulated area as described in this unit.
EPA is proposing to require each owner or operator to establish an
initial baseline monitoring sample to determine the magnitude of
exposure for all persons who may be exposed to TCE within 180 days (6
months) after the date of publication of the final rule in the Federal
Register. Where TCE is present in the workplace, each owner or operator
would be required to determine each potentially exposed person's
exposure by either taking a personal breathing zone air sample of each
potentially exposed person or taking personal breathing zone air
samples that are representative of each potentially exposed person's
exposure performing the same or substantially similar operations in
each work shift, in each job classification, and in each work area
(hereinafter identified as an ``exposure group''). Representative 8-
hour TWA exposures must be determined based on one or more samples
representing full-shift exposures for each shift for each person in
each job classification in each work area. Monitoring samples must be
taken when and where the operating conditions are best representative
of each potentially exposed person's full-shift exposures, and also
must represent the highest TCE exposures likely to occur under
reasonably foreseeable conditions of use. EPA expects that owners and
operators would attempt to monitor a baseline for all of the tasks
during the same timeframe; however, EPA understands that certain tasks
occur less frequently, and EPA is soliciting comments regarding the
timing of the initial exposure monitoring so that it would be
representative of all tasks involving TCE where exposures may approach
the ECEL. If the owner or operator chooses a representative sample,
such sampling must include persons that are the closest to the source
of TCE, so that the monitoring results are representative of the most
highly exposed persons in the workplace. EPA is also soliciting
comments regarding use of area source monitoring instead of personal
breathing zone as a representative sample of exposures.
EPA also recognizes that some entities may already have exposure
monitoring data. If the owner or operator has monitoring data conducted
within five years prior to the effective date of the final rule and the
monitoring would satisfy the monitoring requirements described in this
unit, including the requirement that the data represent the highest TCE
exposures likely to occur under reasonably foreseeable conditions of
use, the owner or operator may rely on such earlier monitoring results
for the initial baseline monitoring
[…truncated; see source link]Indexed from Federal Register on October 31, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.