Rule2024-29274
Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 17, 2024
Effective
January 16, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is finalizing a rule to address the unreasonable risk of injury to health presented by trichloroethylene (TCE) under its conditions of use. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk. EPA's final rule will, among other things, prevent serious illness associated with uncontrolled exposures to the chemical by preventing consumer access to the chemical, restricting the industrial and commercial use of the chemical while also allowing for a reasonable transition period with interim worker protections in place where an industrial and commercial use of the chemical is being prohibited, and provide time-limited exemptions for critical or essential uses of TCE for which no technically and economically feasible safer alternatives are available.
Full Text
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<title>Federal Register, Volume 89 Issue 242 (Tuesday, December 17, 2024)</title>
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[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Rules and Regulations]
[Pages 102568-102635]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29274]
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Vol. 89
Tuesday,
No. 242
December 17, 2024
Part VIII
Environmental Protection Agency
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40 CFR Part 751
Trichloroethylene (TCE); Regulation Under the Toxic Substances Control
Act (TSCA); Final Rule
Federal Register / Vol. 89 , No. 242 / Tuesday, December 17, 2024 /
Rules and Regulations
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0642; FRL-8317-02-OCSPP]
RIN 2070-AK83
Trichloroethylene (TCE); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing a rule to address the unreasonable risk of injury to health
presented by trichloroethylene (TCE) under its conditions of use. TSCA
requires that EPA address by rule any unreasonable risk of injury to
health or the environment identified in a TSCA risk evaluation and
apply requirements to the extent necessary so that the chemical no
longer presents unreasonable risk. EPA's final rule will, among other
things, prevent serious illness associated with uncontrolled exposures
to the chemical by preventing consumer access to the chemical,
restricting the industrial and commercial use of the chemical while
also allowing for a reasonable transition period with interim worker
protections in place where an industrial and commercial use of the
chemical is being prohibited, and provide time-limited exemptions for
critical or essential uses of TCE for which no technically and
economically feasible safer alternatives are available.
DATES: This final rule is effective on January 16, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0642, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: 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#207463650e74736361604550410e474f56"><span class="__cf_email__" data-cfemail="1e4a5d5b304a4d5d5f5e7b6e7f30797168">[email protected]</span></a>.
For general information: 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#92c6c1d1d3bfdafde6fefbfcf7d2f7e2f3bcf5fde4"><span class="__cf_email__" data-cfemail="91c5c2d2d0bcd9fee5fdf8fff4d1f4e1f0bff6fee7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, distribute
in commerce, use, or dispose of TCE or products containing TCE. TSCA
section 3(9) defines the term ``manufacture'' to mean ``to import into
the customs territory of the United States (as defined in general note
2 of the Harmonized Tariff Schedule of the United States), produce, or
manufacture.'' Therefore, unless expressly stated otherwise, importers
of TCE are subject to any provisions regulating manufacture of TCE (see
also Unit I.A.2.). 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);
<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);
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<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);
<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);
[[Page 102570]]
<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);
<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).
2. Applicability to Importers and Exporters
This action may also affect certain entities subject to import
certification and export notification requirements under TSCA (<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>). Persons who import any
chemical substance in bulk form, as part of a mixture, or as
[[Page 102571]]
part of an article (if required by rule) are subject to 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(i)). Those persons must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA (see 19 CFR 12.121). 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 final 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. Any person who exports or intends to export
TCE must comply with the export notification requirements in 40 CFR
part 707, subpart D.
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the Agency
determines through a TSCA section 6(b) risk evaluation that a chemical
substance presents an unreasonable risk of injury to health or the
environment, EPA must by rule apply one or more requirements listed in
TSCA section 6(a) to the extent necessary so that the chemical
substance or mixture no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined in 2023 that TCE
presents an unreasonable risk of injury to health, without
consideration of costs or other non-risk factors, including an
unreasonable risk to potentially exposed or susceptible subpopulations
(PESS) identified by EPA as relevant to the 2020 Risk Evaluation for
TCE under the conditions of use (Refs. 1, 2). A description of the
conditions of use that contribute to EPA's determination that TCE
presents an unreasonable risk is in III.B.1. of the proposed rule (88
FR 74712, October 31, 2023 (FRL-8317-01-OCSPP), with a summary in Unit
II.C.4 of this final rule. Accordingly, to address the unreasonable
risk, EPA is issuing this final rule to:
(i) Prohibit the manufacture (including import), processing, and
distribution in commerce of TCE for all uses (including all consumer
uses (see Unit IV.B.2.)), as described in Unit IV.B., with longer
compliance timeframes for manufacture, processing, and distribution in
commerce related to certain industrial and commercial uses;
(ii) Prohibit the industrial and commercial use of TCE, as
described in Unit IV.B.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 hydrofluorocarbon 134a
(HFC-134a), following an 8.5-year phase-out, as described in Unit
IV.B.3.;
(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 phase-out, outlined in Unit
IV.B.4.;
(v) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of TCE as a laboratory chemical for
asphalt testing and recovery, following a 10-year phase-out, outlined
in Unit IV.B.5.;
(vi) Prohibit the manufacture (including import), processing,
distribution in commerce, and industrial and commercial use of TCE as a
solvent in batch vapor degreasing for essential aerospace parts and
components and narrow tubing used in medical devices, following a 7-
year TSCA section 6(g) exemption, outlined in Unit IV.G.1.;
(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 rocket engine
cleaning by Federal agencies and their contractors, following a 7-year
TSCA section 6(g) exemption, outlined in Unit IV.G.2.;
(viii) For vessels of the Armed Forces 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 agents to satisfy cleaning
requirements (which includes degreasing using wipes, sprays, solvents
and vapor degreasing) for: materials and components required for
military ordnance testing; temporary resin repairs in vessel spaces
where welding is not authorized; ensuring polyurethane adhesion for
electronic systems and equipment repair and installation of elastomeric
materials; various naval combat systems, radars, sensors, equipment;
fabrication and prototyping processes to remove coolant and other
residue from machine parts; machined part fabrications for naval
systems; installation of topside rubber tile material aboard vessels;
and vapor degreasing required for substrate surface preparation prior
to electroplating processes, following a 10-year TSCA section 6(g)
exemption, outlined in Unit IV.G.3.;
(ix) Prohibit the emergency industrial and commercial use of TCE in
furtherance of the NASA mission for specific conditions which 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, outlined in Unit IV.G.4.;
(x) Prohibit the manufacture (including import), processing,
distribution in commerce, disposal, and use of TCE as a processing aid
for manufacturing battery separators for lead acid batteries, following
a 20-year TSCA section 6(g) exemption, as described in Unit IV.G.5.;
(xi) Prohibit the manufacture (including import), processing,
distribution in commerce, disposal, and use of TCE as a processing aid
for manufacturing specialty polymeric microporous sheet materials
following a 15-year TSCA section 6(g) exemption, as described in Unit
IV.G.6.;
(xii) 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 IV.G.7.;
(xiii) Require strict workplace controls to limit exposure to TCE,
including compliance with a TCE workplace chemical protection program
(WCPP), which would include requirements for an interim existing
chemical exposure limit (ECEL) revised from the proposed rule, as well
as dermal protection, for conditions of use with long term phase-outs
or time-limited exemptions under TSCA section 6(g), as described in
Unit IV.C., or prescriptive workplace controls, as described in Unit
IV.D.;
(xiv) Prohibit the disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works, through a
phaseout allowing for longer timeframes for disposal necessary for
certain industrial and commercial uses as described in Unit IV.B.6.,
along with a 50-year TSCA section 6(g)
[[Page 102572]]
exemption for disposal for cleanup projects before prohibition, as
described in Unit IV.G.8., and interim requirements for wastewater
worker protection, as described in Unit IV.E.; and
(xv) Establish recordkeeping and downstream notification
requirements, as described in Unit IV.F.
EPA notes that all TSCA conditions of use of TCE are subject to
this final rule. ``Conditions of use'' is defined in TSCA section 3(4)
to mean the circumstances, as determined by EPA, under which a chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
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 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 for TCE 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. On
October 31, 2023, EPA issued a proposed rule (88 FR 74712) (FRL-8317-
01-OCSPP) under TSCA section 6(a) to regulate TCE so that it no longer
presents unreasonable risk (hereinafter ``2023 TCE proposed rule'').
The Agency received public comment on the proposed rule, and with this
action, EPA is finalizing the 2023 TCE proposed rule with modifications
so that TCE no longer presents an unreasonable risk. The conditions of
use that contribute to the unreasonable risk from TCE are described in
Unit III.B.1. of the 2023 TCE proposed rule.
EPA emphasizes that while some of the adverse effects from TCE
exposure are experienced following acute single exposures, other risks
are incurred following long-term repeated exposures. Risks of non-
cancer effects, specifically fetal cardiac defects and autoimmunity,
are the most sensitive adverse effects following exposure. 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 (liver, kidney, and non-
Hodgkin's lymphoma). This final rule will eliminate the unreasonable
risk to human health from TCE, as identified in the 2020 Risk
Evaluation for TCE (Ref. 1) and the 2023 Revised Unreasonable Risk
Determination for TCE (Ref. 2).
While EPA's rule will result in a ban of TCE, the timeframes for
the phase-outs differ across conditions of use and are described in
fuller detail in Unit IV.B. One phase-out 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 is implementing a longer phase-out 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. of the 2023 TCE proposed
rule.
Additionally, the Agency recognizes that alternatives to TCE may
not be readily available for some important conditions of use. As an
example, EPA is finalizing a longer phase-out timeframe for 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. Currently,
substitutes and alternative processes do not meet the technical
specifications required to clean the rayon fabric in order to safely
produce rockets. Similarly, EPA is finalizing a longer phase-out for
the industrial and commercial use of TCE in laboratory use for asphalt
testing and recovery, based on information provided by state
departments of transportation and regulated entities regarding the
timeframes needed for revising state certifications that currently
include this use of TCE for, among other activities, enabling the
recycling of asphalt.
Additionally, EPA recognizes that some conditions of use may be
important for national security applications or for other critical
needs. For these reasons, this final rule includes a 15-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 battery separators, as well as for the manufacturing,
processing, and distribution in commerce of TCE for this use. EPA
recognizes that 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 finalizing 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 finalizing a 50-year exemption under TSCA section
6(g) for the industrial and commercial use of TCE for critical
laboratory activities; 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.
EPA proposed and is finalizing a requirement to comply with a WCPP,
which includes monitoring, adherence to industrial hygiene best
practices, and requirements to meet an interim ECEL as a condition for
most of the conditions of use for which a phase-out or time-limited
exemption was provided. For the remaining conditions of use for which a
phase-out or time-limited exemption was provided, EPA is requiring
prescriptive worker controls. For many of the conditions of use for
which EPA is finalizing longer phase-outs or time-limited exemptions
under the WCPP, data were submitted to support many commenters'
position that a higher interim ECEL than the limit proposed is
necessary for successful implementation of worker protections before
those conditions of use are prohibited. These comments were submitted
to inform the risk evaluation, Small Business Advocacy Review (SBAR)
Panel process, the comment period following publication of the 2023 TCE
proposed rule, or during stakeholder outreach, and are available in the
corresponding public dockets (EPA-HQ-OPPT-2020-0642; EPA-HQ-OPPT-2019-
0500; EPA-HQ-OPPT-2016-0737, respectively).
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis of the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking
[[Page 102573]]
docket (Ref. 3). As described in more detail in the Economic Analysis
(Ref. 3), EPA was unable to quantify all incremental costs of this
rule. The quantifiable cost of the rule is estimated to be $64.1
million annualized over 20 years at a 2% discount rate, $71.3 million
annualized at 3%, and $102.4 million annualized at a 7% discount rate.
These costs take into consideration costs of compliance with
implementation of an interim WCPP for certain conditions of use, based
on an interim ECEL of 0.2 ppm (1.07 mg/m\3\) for inhalation exposures
as an 8-hour time-weighted average (TWA), costs for transitioning to
alternatives, where possible, and reformulation costs of numerous
products. Estimated costs for the interim WCPP include costs for
monitoring and applicable personal protective equipment (PPE). There
are a number of notable unquantified costs. These are described in this
Unit and more fully in section 7.12 of the Economic Analysis.
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 including costs to develop
alternatives where they 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, such as energized electrical
equipment cleaners and adhesives and sealants specifically for
aerospace 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 used available air monitoring data as
well as modelled data to estimate a distribution of exposure
concentrations, 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 compliance with
the WCPP are uncertain. The WCPP costs also assume that when the
exposure levels exceed the interim ECEL, compliance is achieved by
implementing a respirator PPE program. However, and consistent with the
hierarchy of controls, the final rule requires implementation of
feasible engineering and administrative controls before using PPE to
reduce exposure to or below the interim ECEL. 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 could not be estimated for battery separator
manufacturers, synthetic paper processors, and fluoroelastomer
producers. It is expected that these facilities would need to adopt
process and/or physical plant changes in order to comply with the rule.
EPA does not have sufficient information to estimate the costs of the
prohibition to these sectors.
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 this rule will hasten the closure of
plants that use TCE to produce HFC-134a. There could be some unknown
cost impacts associated with hastening the closure of these two plants.
EPA is finalizing a 10-year phase-out 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 prohibition of TCE used in vapor degreasing for narrow tubing
for aerospace and medical devices is expected to require testing and
certification of alternative solvents and/or processes to meet strict
safety and performance requirements. These costs will be specific to a
facility's design, selected alternative, and end use of the product.
EPA does not have information to estimate the costs associated with
meeting these safety and performance requirements.
The disposal of TCE from cleanup projects to industrial pre-
treatment, industrial treatment, or publicly owned treatment works is
prohibited after the TSCA section 6(g) exemption ends, 50 years after
the rule is finalized. If cleanup is not finished by the end of this
time period and the TSCA section 6(g) exemption has not been extended,
cleanup sites will need to identify and implement alternative disposal
or treatment methods and will likely also need to renegotiate Resource
Conservation and Recovery Act (RCRA) permits or Comprehensive
Environmental Response, Compensation, and Liability Act (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.
During the timeframe of the exemptions, this rule requires owners
and operators of cleanup sites with TCE exposures to potentially
exposed persons (e.g., workers or others in the workplace, such as
persons directly handling the chemical or in the area where the
chemical is being used) as well as publicly owned treatment works
(POTWs) receiving TCE wastes from cleanup sites, battery separator
manufacturers, and specialty polymeric microporous sheet material
manufacturers to comply with the Occupational Safety and Health
Administration's (OSHA's) Hazardous Waste Operations and Emergency
Response (HAZWOPER) requirements modified to incorporate the interim
ECEL (for cleanup sites) and WCPP requirements modified to include a
water screening method (for POTWs). EPA does not have sufficient
information to estimate the number of sites and workers that may need
to meet the requirements to protect potentially exposed persons and
could not estimate the costs for those protections. In addition, the
economic analysis does not estimate costs regarding disposal of TCE or
TCE-containing products after the effective date prohibiting the
industrial and commercial use and disposal of TCE to industrial pre-
treatment, industrial treatment, or publicly owned treatment works. The
final rule includes a staggered compliance timeline throughout the
supply chain to allow for much of the TCE to be used before disposal is
necessary. However, some unused product may need to be disposed of as
hazardous waste. Since there is no reliable way of estimating the
volume of this waste, the additional disposal costs are not quantified
in this economic
[[Page 102574]]
analysis. Finally, EPA could not estimate any potential business
closures or off-shoring of businesses that might result from the 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
and commenters, including through a SBAR Panel, it is not clear whether
or how many firms might choose closure as a compliance strategy, nor
what the costs might be.
Following the mandate of TSCA to address unreasonable risk to
health as well as in alignment with the goals of President Biden's
Cancer Moonshot, the rule will protect people from cancer and other
significant adverse health effects of TCE by prohibiting the
manufacture (including import), processing, and distribution in
commerce of TCE for all uses while allowing for a longer reasonable
transition period or time-limited exemptions for certain uses (Ref. 5).
The actions in this final rule are expected to achieve health benefits
for the American public, some of which can be monetized and others
that, while tangible and significant, cannot be monetized due to data
and methodology limitations. The monetized benefits of this rule are
approximately $22.9 million to $ 23.2 million annualized over 20 years
at a 2% discount rate, $18.2 million to $18.3 million annualized over
20 years at 3%, and $8.7 million to $ 8.9 million annualized over 20
years at a 7% discount rate. These monetized benefits only include
potential reductions in risk of liver, kidney, and non-Hodgkin's
lymphoma cancers associated with reducing chronic TCE exposure.
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 rule with respect to these noncancer effects, and therefore
monetized benefits are likely underestimated.
EPA does estimate that there 67,869 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 1,162
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.
6) 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. 7). Additional
social costs may include caregiver burden and mental health services
(Ref. 8), 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.
Additionally, to the extent that the 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
As described in more detail in the 2023 TCE proposed rule, TCE is
an immunotoxicant and developmental toxicant and is carcinogenic to
humans by all routes of exposure. This final rule is specifically
intended to address the unreasonable risk of injury to health that EPA
has identified in the 2020 Risk Evaluation for TCE (Ref. 1) and 2023
Revised Unreasonable Risk Determination (Ref. 2), as described in Unit
II.D. of the 2023 TCE proposed rule. 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 the most recent
(2020) Chemical Data Reporting (CDR) data (Ref. 9). 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. Other uses account for approximately
1.7% of TCE production volume. TCE is used as a solvent in a variety of
commercial and consumer applications including in lubricants, adhesives
and sealants, paints and coatings, and other miscellaneous products.
B. Regulatory Actions Pertaining to TCE
Because of its significant adverse health effects, TCE is subject
to numerous State, Federal, and international regulations restricting
and regulating its use. A summary of EPA regulations pertaining to TCE,
as well as other Federal, State, and international regulations, is in
the docket (Ref. 10).
As described in more detail in the 2023 TCE proposed rule and in
the Response to Public Comments document (Ref. 11), EPA considered the
adequacy of the current regulation of TCE by OSHA for protection of
workers. EPA notes that the standards for chemical hazards that OSHA
promulgates under the Occupational Safety and Health (OSH) Act share a
[[Page 102575]]
broadly similar purpose with the worker protection-related 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, 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 when
evaluating and addressing potential unreasonable risk to workers so
that compliance requirements are clearly explained to the regulated
community. TSCA risk evaluations are subject to statutory science
standards, an explicit requirement to consider risks to potentially
exposed or susceptible subpopulations, and a prohibition on considering
costs and other non-risk factors when determining whether a chemical
presents an unreasonable risk that warrants regulatory actions--all
requirements that do not apply to development of OSHA regulations. As
such, EPA may find unreasonable risk for purposes of TSCA
notwithstanding OSHA requirements. 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. While it is possible
in some cases that the OSHA standards for some chemicals reviewed under
TSCA will eliminate unreasonable risk, based on EPA's experience thus
far in conducting occupational risk assessments under TSCA, EPA
believes that OSHA chemical standards would in general be unlikely to
address unreasonable risk to workers within the meaning of TSCA, since
TSCA section 6(b) unreasonable risk determinations may account for
unreasonable risk to more sensitive endpoints and working populations
than OSHA's risk evaluations typically contemplate and EPA is obligated
to apply TSCA section 6(a) risk management requirements to the extent
necessary so that the unreasonable risk is no longer presented. Because
the requirements and application of TSCA and OSHA regulatory analyses
differ, 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. Additional considerations of OSHA standards in the revised
unreasonable risk determination are discussed further in the 2023
Revised Unreasonable Risk Determination for TCE (88 FR 1222, January 9,
2023 (FRL-9945-02-OCSPP)).
C. Summary of EPA's Risk Evaluation Activities on TCE
In July 2017, 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 risk determination for TCE (87 FR 40520, July 7, 2022
(FRL-9945-01-OCSPP)), and, after public notice and comment, published a
Revised 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 ID No. EPA-HQ-OPPT-2019-0500, and
the January 2023 Revised Unreasonable Risk Determination for TCE and
additional materials supporting the risk evaluation process are in
Docket ID No. EPA-HQ-OPPT-2016-0737. Both dockets can be accessed
online through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. 2020 Risk Evaluation for TCE
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. of the 2023 TCE
proposed rule. The 2020 Risk Evaluation for TCE identified significant
adverse health effects associated with short- and long-term exposure to
TCE. A further discussion of the hazards of TCE is presented in Unit
III.B.2. of the 2023 TCE proposed rule.
2. 2023 Revised Unreasonable Risk Determination for TCE
As described in more detail in EPA's 2023 TCE proposed rule, 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 consistent with Executive Order 13990 (``Protecting
Public Health and the Environment and Restoring Science to Tackle the
Climate Crisis'') and other Administration priorities. The revisions
consisted of making the risk determination based on the whole chemical
substance instead of making risk determinations for each individual
condition of use, which resulted in the revised risk determination
superseding the prior ``no unreasonable risk'' determinations for
specific conditions of use (Ref. 2), the withdrawal of the associated
TSCA section 6(i)(1) ``no unreasonable risk'' order, and clarification
that the risk determination does not reflect an assumption that all
workers are always provided and appropriately wear PPE (Ref. 2).
EPA determined that TCE presents an unreasonable risk of injury to
health and did not identify risks of injury to the environment that
contribute to the unreasonable risk determination for TCE. The TCE
conditions of use that contribute to EPA's determination that the
chemical substance poses unreasonable risk to health are listed in the
unreasonable risk determination (Ref. 2) and the 2023 TCE proposed
rule, with descriptions to aid chemical manufacturers, processors, and
users in determining how their particular use or activity would be
addressed under the final regulatory action.
3. Description of Unreasonable Risk
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 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
[[Page 102576]]
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. EPA also concluded, based on EPA's Guidelines for Carcinogen
Risk Assessment (Ref. 12), that TCE is carcinogenic by all routes of
exposure, and identified cancer risk (liver, kidney, and non-Hodgkin
lymphoma) from chronic inhalation and dermal exposures (Ref. 2). Unit
VII. of the 2023 TCE proposed rule summarizes the health effects and
the magnitude of the exposures.
To make the unreasonable risk determination for TCE, EPA evaluated
exposures to PESS 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. of the 2023 TCE proposed rule.
For the 2020 Risk Evaluation for TCE, and as discussed in Unit
II.D.1. and Unit III.A.3. of the 2023 TCE proposed rule, 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 and
bystanders (of any age group, including infants, toddlers, children,
and elderly), including biologically susceptible subpopulations.
Additionally, older pregnant women are identified as especially
susceptible to cardiac defects in their developing fetus based on
epidemiological data (Ref. 1). All PESS are included in the
quantitative and qualitative analyses described in the 2020 Risk
Evaluation for TCE and were considered in the determination of
unreasonable risk for TCE (Refs. 1, 2).
4. Conditions of Use Subject to This Regulatory Action
As noted in Unit I.C. of this final rule, the term ``conditions of
use'' is defined in TSCA section 3(4). Condition of use descriptions
are provided in Unit III.B.1. of the 2023 TCE proposed rule and 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. EPA did not receive public comments
identifying inaccuracies or necessitating changes to those
descriptions; however, EPA received some comments requesting
clarification for particular uses, which can be found in the Response
to Comments document (Ref. 11). Additionally, to assist with
implementation and compliance with the final rule, in Units IV.C.1.,
IV.D.1., and IV.E.1. of this final rule, EPA has provided a description
of the conditions of use that are subject to the WCPP or other
workplace controls during phaseout or time-limited exemption before
prohibition.
For the purposes of this final rule, ``occupational conditions of
use'' refers to the TSCA conditions of use other than consumer use as
described in Units III.B.1.a., b., c., and e. of the 2023 TCE proposed
rule. Although EPA identified both industrial and commercial uses in
the 2020 Risk Evaluation for TCE (Ref. 1) for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority Congress gave to the Agency to
``regulat[e] any manner or method of commercial use'' under TSCA
section 6(a)(5) to reach both industrial and commercial uses.
Additionally, as described in the 2023 TCE proposed rule and in the
2020 Risk Evaluation for TCE (Ref. 1), EPA identified and assessed all
known, intended, and reasonably foreseen industrial, commercial, and
consumer uses of TCE. EPA determined that all industrial, commercial,
and consumer uses of TCE evaluated in the 2020 Risk Evaluation for TCE
contribute to the unreasonable risk of injury to health. As such, for
purposes of this risk management rule, ``consumer use'' refers to all
known, intended, or reasonably foreseen TCE consumer uses. Likewise,
for the purpose of this risk management rule, ``industrial and
commercial use'' refers to all known, intended, or reasonably foreseen
TCE industrial and commercial uses.
EPA further notes that this rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(i) 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, when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic or device.
D. EPA's 2023 Proposed Rule for TCE
1. Description of TSCA Section 6(a) Requirements
Under TSCA section 6(a), if the Administrator determines through a
TSCA section 6(b) risk evaluation that a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an
unreasonable risk to a PESS identified as relevant to the Agency's risk
evaluation, under the conditions of use, EPA must by rule apply one or
more of the section 6(a) requirements to the extent necessary so that
the chemical substance no longer presents such risk.
The TSCA section 6(a) requirements can include one or more of the
following actions alone or in combination:
<bullet> Prohibit or otherwise restrict the manufacturing
(including import), 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
(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
(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
(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
(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 (section 6(a)(4)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (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,
[[Page 102577]]
by its manufacturer or processor or by any person who uses or disposes
of it for commercial purposes (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 (section 6(a)(7)).
In the 2023 TCE proposed rule, EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk
from TCE so that it no longer presents such risk. This unit summarizes
the TSCA section 6 considerations for issuing regulations under TSCA
section 6(a), and Unit IV. outlines how EPA applied these
considerations while managing the unreasonable risk from TCE.
As required, EPA developed a proposed regulatory action and one
primary alternative regulatory action, which are described in Units
V.A. and V.B. of the 2023 TCE the proposed rule, 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, 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 also
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 levels 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) regulatory requirements for the
proposed rule. EPA's considerations regarding TSCA section 6(c)(2) for
TCE are discussed in full in Unit VII. of the 2023 TCE proposed rule,
including the statement of effects with respect to the section
6(c)(2)(A) considerations.
As described in more detail in the 2023 TCE proposed rule, EPA also
considered regulatory authorities under statutes administered by other
agencies such as the Occupational Safety and Health (OSH) Act, the
Consumer Product Safety Act (CPSA), and the Federal Hazardous
Substances Act (FHSA), as well as other EPA-administered statutes, to
examine (1) Whether there are opportunities to address unreasonable
risk under other statutes, such that a referral may be warranted under
TSCA section 9(a) or 9(b); or (2) Whether TSCA section 6(a) regulation
could include alignment of requirements and definitions in and under
existing statutes and regulations to minimize confusion to the
regulated entities and the general public.
Additionally, as described in more detail in EPA's 2023 TCE
proposed rule in Unit VI.B, EPA considered the availability of
alternatives when finalizing a prohibition or a substantial restriction
(TSCA section 6(c)(2)(C)), and in setting final compliance dates in
accordance with the requirements in TSCA section 6(d)(1).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and the National Institute for Occupational Safety and Health
(NIOSH) when developing its proposed rule, with the goal of identifying
risk management control methods that would be permanent, feasible, and
effective. EPA also considered how to address the unreasonable risk
while providing flexibility to the regulated community where
appropriate and took into account the information presented in the 2020
Risk Evaluation for TCE (Ref. 1), input from stakeholders, insight
received during consultations, and anticipated compliance strategies
from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative action described in this
Unit. Additional details related to how the requirements in this Unit
were incorporated into development of the proposed rule and primary
alternative action are in Unit VI. of the 2023 TCE proposed rule.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and outreach as part of development of
the 2023 TCE proposed rule. The Agency held a federalism consultation
from July 22, 2021, until October 22, 2021, as part of the rulemaking
process and pursuant to Executive Order 13132 (Ref. 13).
EPA also consulted with tribal officials during the development of
the 2023 TCE proposed rule. The Agency held a tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8,
2021 (Ref. 14). EPA received no written comments as part of this
consultation.
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 consultations (Refs. 15, 16, 17, 18). A
brief summary of the comments is in Unit III.A.1 of the 2023 TCE
proposed rule.
As required by section 609(b) of the Regulatory Flexibility Act
(RFA), EPA convened a SBAR Panel to obtain advice and recommendations
from Small Entity Representatives (SERs) that potentially would be
subject to the rule's requirements. EPA met with SERs before and during
Panel proceedings, on October 28, 2022, and January 31, 2023. Panel
recommendations were presented in the SBAR Panel report (Ref. 19) and
were addressed in Unit XI.C. of the 2023 TCE proposed rule and in the
Initial Regulatory Flexibility Analysis (IRFA) (Ref. 20). EPA has also
prepared a Final Regulatory Flexibility Analysis (FRFA) (Ref. 21).
More information about these consultations is presented in Units
III.A.1., XI.C., XI.E., XI.F., and XI.J. of the 2023 TCE proposed rule.
b. Other Stakeholder Consultations
For development of the proposed rule, in addition to the formal
consultations described in Unit XI. of the 2023 TCE proposed rule, EPA
provided an overview of the TSCA risk management process and the risk
evaluation findings for TCE on December 15, 2020 (Ref. 22). EPA also
presented on the TSCA risk management process and the findings in the
2020 Risk Evaluation for TCE at a Small Business Administration (SBA)
Office of Advocacy Environmental Roundtable on December 18, 2020 (Ref.
19). Attendees of these meetings were given an opportunity to voice
their concerns regarding the risk evaluation and risk management.
Furthermore, during development of the proposed rule, EPA engaged
in discussions with representatives from different industries, non-
governmental organizations, technical experts, organized labor, and
users of TCE. A list of external meetings held during the development
of the 2023 TCE proposed rule is in the docket (Ref. 23); meeting
materials and summaries are also in the docket. See Unit III.A.2. of
the 2023 TCE proposed rule for a summary of the topics discussed during
the meetings.
c. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 24) requires
EPA
[[Page 102578]]
to protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
and 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 PESS identified as relevant to the
risk evaluation by the Administrator, under the conditions of use.'' In
addition, TSCA section 6(a) requires EPA to apply one or more risk
management requirements so that TCE no longer presents an unreasonable
risk (which includes unreasonable risk to any relevant PESS).
Information about the health and risk assessments supporting this
action and how the Policy was applied is presented in Unit II.C.,
II.D., and IV.A. of the 2023 TCE proposed rule, as well as in the 2020
Risk Evaluation for TCE, and the Economic Analysis for this rule (Refs.
25, 1, 3).
3. Proposed Regulatory Action
EPA's 2023 TCE proposed rule under TSCA section 6(a) to address the
unreasonable risk presented by TCE under its conditions of use included
the following:
(i) Prohibition of the manufacture (including import), processing,
and distribution in commerce of TCE for all uses (including all
consumer uses), with longer compliance timeframes for manufacture and
processing related to certain uses;
(ii) Prohibition of the industrial and commercial use of TCE, with
longer compliance timeframes for certain uses;
(iii) Prohibition of the manufacture (including import) and
processing of TCE as an intermediate for the manufacturing of HFC-134a,
following an 8.5-year phase-out;
(iv) Prohibition of 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 phase-out;
(v) For vessels of the Armed Forces and their systems, and in the
maintenance, fabrication, and sustainment for and of such vessels and
systems, prohibition of 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 agents to satisfy 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;
(vi) Prohibition of 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;
(vii) Prohibition of 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;
(viii) Prohibition of 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 NASA and its contractors,
following a 7-year TSCA section 6(g) exemption;
(ix) Prohibition of the emergency industrial and commercial use of
TCE in furtherance of the NASA mission for specific conditions which
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;
(x) Requirements for strict workplace controls, including
compliance with a TCE 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 phase-outs or time-limited
exemptions under TSCA section 6(g);
(xi) Prohibition of, 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; and
(xii) Requirements for recordkeeping and downstream notification.
EPA notes that all TSCA conditions of use of TCE were subject to
the 2023 TCE proposed rule and are subject to this final rule.
The proposed rule included timeframes for implementation. The
prohibitions EPA proposed would take effect in phases, beginning at the
top of the supply chain, and coming into full effect, for most
conditions of use, after 90 days for manufacturers, in 180 days for
processors, and in 270 days for most industrial and commercial users,
with different timeframes related to specific conditions of use.
Specifically, for processing TCE as a reactant/intermediate, EPA
proposed that the compliance dates for the proposed prohibitions would
come into effect in 1.5 years for manufacturers and 2 years for
processors EPA proposed additional exceptions from the prohibition for
the manufacturing and processing associated with certain processing and
industrial and commercial uses, including phase-outs (see Units
V.A.1.b., d., and e., of the 2023 TCE proposed rule or time-limited
exemptions under TSCA section 6(g) (see Unit V.A.3.b. of the 2023 TCE
proposed rule). Likewise, for the WCPP that would be required for
several conditions of use before prohibitions went into effect, EPA
proposed timeframes for phases of compliance, beginning with monitoring
at 180 days and full implementation after 1 year, as described in Unit
V.A.1. of the 2023 TCE proposed rule.
As required under TSCA section 6(c)(2)(A)(iv)(II) through (III),
EPA presented its consideration of an alternative regulatory action in
the Unit V.B. of the 2023 TCE proposed rule. Similar to the proposed
regulatory action, the alternative regulatory action combined
prohibitions with requirements for a WCPP for certain conditions of use
before they would be prohibited, to address the unreasonable risk from
TCE under its conditions of use. The primary alternative regulatory
action described in the proposed rule differed from the proposed
regulatory action by providing longer timeframes for prohibitions, and
by describing an ECEL based on a different health endpoint (i.e.,
immunotoxicity), as part of the WCPP that would be required for the
conditions of use of TCE that would be permitted to continue for longer
than one year after publication of the final rule until the prohibition
compliance dates. The ECEL for the WCPP under the
[[Page 102579]]
proposed rule's primary alternative regulatory action was based on the
endpoint used for EPA's unreasonable risk determination for TCE under
TSCA (i.e., immunotoxicity (Ref. 2)). In contrast, the ECEL for the
WCPP under the proposed regulatory action was based on the most
sensitive health endpoint (developmental toxicity). The rationale for
these differences is discussed in Unit V.A, of this rule and Unit
VI.A.1.a. of the 2023 TCE proposed rule.
For a comprehensive overview of the alternative regulatory action,
refer to Unit V.B. of the 2023 TCE proposed rule, with the rationale
for the primary alternative regulatory action provided in Unit VI.B. of
the 2023 TCE proposed rule.
4. Public Comments Received
EPA requested comment on all aspects of the 2023 TCE proposed rule.
During the public comment period, EPA held a webinar on November 14,
2023, providing an overview of the proposed rule and TSCA section 6;
during the webinar, members of the public had the opportunity to share
their perspectives (Ref. 26). The comment period closed on December 15,
2023. EPA received almost 30,000 public comments, with a vast majority
received from individuals participating in mass mailer campaigns
organized by non-governmental organizations. The public comments also
include approximately 200 unique comments from industry stakeholders,
trade associations, environmental groups, unions, non-governmental
health advocacy organizations, academics, State and local governments,
and members of the regulated community. A summary of the comments, as
well as EPA's responses, is in the docket for this rulemaking (Ref.
11). Additionally, Unit III. contains summaries of public comments that
informed EPA's regulatory approach in this final rule.
After the close of the public comment period for the proposed rule,
EPA held meetings with stakeholders to receive clarifying information
on their comments, including affected industry and interested groups,
related to the use of TCE. Topics of these meetings included exposure
controls, process descriptions, monitoring data, and specific
conditions of use. EPA received data as part of and following these
stakeholder meetings and has made the information available to the
public in the rulemaking docket (EPA-HQ-OPPT-2020-0642) (Ref. 27).
After review of the public comments received from the 2023 TCE
proposed rule, EPA revised certain preliminary considerations that
impacted the length of time-limited exemptions from prohibition under
TSCA section 6(g) and key provisions of the WCPP (including
identification of a new, interim ECEL), among other changes. Similarly,
based on public comments received, EPA modified for this final rule
several proposed compliance timeframes, with details provided in Unit
III. of this final rule.
III. Changes From the Proposed Rule
This unit summarizes the main changes from the 2023 TCE proposed
rule to the final rule, based on the consideration of the public
comments.
A. Changes to the WCPP
As part of the conditions for exemptions under TSCA section 6(g) or
phase-outs for several conditions of use before prohibition, EPA
proposed to require owners or operators to comply with a WCPP to reduce
exposures and risks to potentially exposed persons. Numerous commenters
expressed concern regarding the requirements of the WCPP. While EPA is
finalizing as proposed many aspects of the WCPP, the final rule
includes several significant changes, based on consideration of public
comments. The details of and rationale for these changes are described
in this Unit and EPA notes that in the event that sensitive information
relating to national security or critical infrastructure is submitted
to EPA, the Agency will protect such information in accordance with
applicable authorities.
1. Interim Occupational Exposure Limit
EPA proposed requirements to comply with the TCE WCPP for all
conditions of use that would continue for one year or more before
prohibition, as an interim measure to reduce exposures to TCE in the
workplace. As part of the TCE WCPP, EPA proposed that each owner or
operator of a workplace subject to the TCE WCPP ensure that no person
is exposed to airborne concentrations above the occupational exposure
limit to the extent possible. EPA proposed an existing chemical
exposure limit, or ECEL, of 0.0011 ppm as an 8-hour TWA. In proposing
to set this risk-based exposure limit, EPA described in Unit IV.A. of
the 2023 TCE proposed rule how the 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 for fetal cardiac defects (Ref.
28).
EPA also described in Unit V.A.2. of the 2023 TCE proposed rule how
a WCPP provides regulated entities with some flexibility in the manner
in which they implement modifications, within certain parameters, or
otherwise aim to prevent exceedances of inhalation exposure limits at
their facilities. EPA proposed or finalized a WCPP for several
conditions of use for other chemicals regulated under TSCA section 6,
such as methylene chloride (89 FR 39254, May 8, 2024 (FRL-8155-01-
OCSPP)), perchloroethylene (PCE) (88 FR 39652, June 16, 2023 (FRL-8329-
02-OCSPP)), and carbon tetrachloride (88 FR 49180, July 28, 2023) (FRL-
8206-01-OCSPP)). The proposed TCE WCPP differed from those other
proposals in two key ways. First, EPA intended for the TCE WCPP to be
in place only as an interim measure before prohibitions take effect
(rather than continuing in perpetuity, as was the case in the other
proposed rules cited previously). Second, for the reasons described in
Unit VI. of the 2023 TCE proposed rule, the proposed rule, 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 was that owners or operators ensure that
no person is exposed to TCE in excess of the ECEL of 0.0011 ppm as an
8-hr TWA to the extent possible 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 challenges in reducing exposure, as well
as the severity of the hazard from TCE, EPA emphasizes that, even with
the proposed ECELs, EPA cannot ensure that TCE does not present
unreasonable risk to workers and, therefore, it is not a substitute for
a ban as a long-term risk management solution. Thus, prohibition of all
conditions of use ultimately is necessary to address the unreasonable
risk.
In the 2023 TCE proposed rule, EPA requested comment on the
proposed ECEL (including the feasibility of the limit, the associated
action level of 0.00055 ppm as an 8-hr TWA, monitoring methods, and
whether a phased approach is desirable). EPA also requested comment on
the ECEL described in the alternative regulatory action (0.004 ppm as
an 8-hr TWA, based on the immunotoxicity endpoint).
Numerous commenters expressed concern that EPA proposed that
compliance with the WCPP would be measured by reaching and documenting
the lowest exposure level that could be achieved, instead of a
requirement to meet an exposure limit (Refs. 29, 30,
[[Page 102580]]
and 31). Additional commenters stated it would not be technically
feasible to meet the proposed ECEL (Refs. 32, 33), despite what they
described as robust implementation of engineering and administrative
controls (Refs. 34, 35). These and other commenters described how they
are not aware of any additional feasible engineering or administrative
controls that would enable them to avoid, under the TCE WCPP, having
employees wear supplied-air respirators at all times (Refs. 34, 35, 36,
37). Commenters expressed several concerns with requiring employees to
wear supplied-air respirators at all times (Refs. 34, 35). Industry
commenters requested a higher interim occupational exposure limit that
would not require an unworkably burdensome level of PPE; commenters
provided numerous suggestions for alternate ECEL values such as 0.36
ppm, 5 ppm, or 6 ppm, each expressed as 8-hr TWAs (Refs. 38, 39, 40,
41). Commenters offered these alternate occupational exposure limits
based on either their current monitoring or on regulatory values set in
other countries, to reduce reliance on extensive respiratory PPE.
Commenters noted that setting an ECEL at the level proposed level or at
the alternative regulatory action ECEL would require potentially
exposed persons across all industries to use high levels of respiratory
protection that EPA acknowledges can represent an occupational hazard
on its own. EPA recognizes the challenges of respiratory PPE. As
detailed in the proposed rule in Unit VI.A.1.b., and in OSHA's 1998
final rule to update its respiratory protection standard, which cited
communication problems, vision problems, worker fatigue, and reduced
work efficiency among such challenges. (63 FR 1152, January 8, 1998).
As OSHA explained, ``improperly selected respirators may afford no
protection at all (for example, use of a dust mask against airborne
vapors), may be so uncomfortable as to be intolerable to the wearer, or
may hinder vision, communication, hearing, or movement and thus pose a
risk to the wearer's safety or health.'' (63 FR 1189 through 1190).
In addition to describing anticipated challenges in meeting the
proposed or the alternative regulatory action ECEL, commenters also
described the challenges they would expect in attempting to monitor
indoor air TCE concentrations at or below the ECEL and ECEL action
level of 0.00055 ppm or the alternative ECEL and alternative ECEL
action level of 0.0002 ppm. Specifically, several commenters emphasized
that laboratories would need to transition from typical methods that
use sorbent tubes and sample media solvent desorption (OSHA Method
1001) to a more sensitive method that may involve a completely
different approach, such as a relevant EPA Compendium Method, and that
these may still not be sufficient due to a level of detection of
volatile organic compounds above 0.5 parts per billion by volume
(ppbv), which is above the proposed ECEL action level (Refs. 38, 39,
42). The commenters also discussed the EPA TO-17 Method, which uses a
sorbent tube/thermal desorption/gas chromatographic-based monitoring
method for VOCs, but emphasized the use of thermal desorption is not
common across the industry (Refs. 38, 39). EPA agrees that while
available monitoring and analytical methods for TCE are possible in the
low parts-per-billion range, typical occupational sampling methods such
as OSHA method 1001 (i.e., personal breathing zone monitoring) used in
industrial hygiene generally allow detection in the 10 to 100 ppb range
(or 0.010 ppm to 0.100 ppm) (Ref. 38). Widespread adoption of
monitoring and sampling methods that could meet a TCE ECEL in the low
parts-per-billion range would be difficult, expensive, and take at
least several years. Public commenters specifically requested the
option to be able to use methods common in occupational sampling, both
for familiarity and from a commercial lab capacity perspective, and
pointed out the proposed ECEL would not provide that ability (Ref. 38).
Additionally, setting a regulatory occupational exposure limit at
0.0011 ppm would be incompatible with the NIOSH-recommended best
practice of monitoring to a fraction (specifically 10%) of the
occupational exposure limit in order to quantify results, because
0.0011ppm is significantly lower than the detection limits of available
monitoring and analytical methods for TCE.
One commenter, a union, stated that setting an ECEL at a level that
cannot be measured would render the rule unenforceable and would
therefore be meaningless for employees continuing to work with TCE
during the phase-out period (Ref. 29). Another commenter, an industry
trade organization, asserted that lowering exposures ``to the extent
possible'' is unenforceable (Ref. 43). Based on the significant
feasibility challenges described by commenters; the need for a robust,
implementable, and enforceable WCPP for conditions of use that would
continue for more than a year before prohibition; EPA's strong interest
in rapidly putting into place the TCE WCPP and resulting exposure
reductions; and the forthcoming future prohibitions that will take
effect on these conditions of use, EPA is finalizing an interim ECEL of
0.2 ppm as an 8-hr TWA with an associated interim ECEL action level of
0.1 ppm as an 8-hr TWA. This occupational exposure level is achievable
to meet, can be reliably and consistently monitored, and will provide
an interim level of protection for conditions of use with longer
timeframes until prohibition.
Several commenters supported the risk-based exposure limit that was
proposed, and stated that, in their view, it is supported by sound
scientific evidence (Refs. 31, 44, 29, 45). The proposed ECEL is based
on data presented in the risk evaluation, which is the best available
science. EPA emphasizes that modifying the final TCE WCPP to include an
interim ECEL does not diminish the scientific rationale for the risk-
based exposure limit that EPA proposed. EPA's justification for
identification of the ECEL that would address unreasonable risk as
0.0011 ppm as an 8-hr TWA is described in detail in the notice of
proposed rulemaking and highlighted section 5 of the Response to
Comments document (Ref. 11). EPA also emphasizes that this interim ECEL
is specific to TSCA and incorporates different considerations than
limits or levels set for TCE exposures in other contexts or inhalation
exposures that are regulated under other authorities, such as RCRA.
EPA's action to finalize an interim ECEL for TCE under TSCA is based on
feasibility considerations during ongoing occupational use of TCE
beyond one year. Specifically, the interim ECEL takes into account
significant challenges potentially exposed persons would experience
from extensive respiratory PPE use in an occupational setting.
EPA is finalizing an interim ECEL of 0.2 ppm as an 8-hr TWA. This
interim ECEL takes into account considerations raised by the
commenters, such as feasibility of implementation in several critical
or essential industries, Specifically, EPA expects that the various
industries subject to the interim ECEL can meet the interim ECEL with
exposure controls that are feasible for owners and operators to
implement for potentially exposed persons over a full shift, using
engineering controls and, in some instances, respiratory PPE. While
certain supplied air respirators could be used to reduce exposures
below the proposed exposure limit, these respirators are burdensome and
EPA is
[[Page 102581]]
not confident that they could be effectively and consistently
implemented on an ongoing basis in a way that fully addresses the
unreasonable risk. EPA views extremely high levels of PPE (e.g.,
assigned protection factor (APF) 10,000) as unable to consistently and
over a long timeframe address occupational risk. As noted earlier,
setting an ECEL at the level proposed would require potentially exposed
persons across all industries to use high levels of respiratory
protection, such as APF 10,000 supplied air respirators, that EPA
acknowledges could represent an occupational hazard on its own due to
communication problems, vision problems, worker fatigue, and reduced
work efficiency. The interim ECEL allows for more robust use of the
hierarchy of controls.
The interim ECEL was also developed with consideration for risk
reduction and health protectiveness. EPA estimates that the 0.2 ppm
interim ECEL would reduce estimated baseline chronic workplace exposure
by 97% (Ref. 28). The reduction in the baseline excess cancer risk is
estimated to be proportional to the reduction in exposure. Acute health
effects would also be reduced to the extent that they are proportional
to exposure reduction. For example, based on EPA's TSCA TCE risk
evaluation, the 0.2 ppm interim ECEL is protective of the acute
immunotoxicity endpoint.
Lastly, the interim ECEL allows for occupational monitoring
methodologies based on validated active, passive, and direct-read
instrumentation. There are several available active sampling methods
(e.g., OSHA 1001, OSHA 5000) that are fully validated methods that
readily allow for compliance with the interim ECEL value of 0.2 ppm for
all affected industries. As described elsewhere in this preamble, this
rule is also finalizing an interim ECEL action level that serves as a
trigger for certain compliance activities (e.g., periodic monitoring).
Therefore, it is important for regulated entities to be able to
reliably and accurately measure both the interim action level and the
interim ECEL value. The interim ECEL also enables use of the NIOSH 1003
(active sampling) method as well as field portable instruments that use
the NIOSH 3701 method for occupational monitoring. While real-time
monitoring with a digital measure device is not required for rule
compliance, EPA understands the practical benefits of field portable
and/or real-time occupational exposure monitoring. In the near term,
the interim ECEL and the associated interim action level aids with
implementation of the WCPP from the perspective of monitoring
methodology and availability. Setting the interim ECEL at a value of
0.2 ppm allows for the immediate implementation of the WCPP, as
monitoring methods are currently available and widely recognized and
used. A lower value interim ECEL would pose technical challenges (i.e.,
achievable with only a subset of monitoring methods) and be less
feasible.
EPA emphasizes that the regulatory limit adopted in this final rule
(0.2 ppm as an 8-hr TWA) will be a significant reduction from the
current regulatory occupational exposure limit (i.e., 500 times lower
than the current OSHA PEL of 100 ppm as an 8-hr TWA) as well as more
than 50 times lower than the voluntary standard frequently cited by
commenters (10 ppm as an 8-hr TWA). EPA expects that regulated entities
may need to make significant, but feasible, changes from current
practice by adopting the WCPP to reduce inhalation exposures
sufficiently and provide risk reduction to potentially exposed persons.
EPA also recognizes that the interim ECEL of 0.2 ppm as an 8-hr TWA
does not fully address the unreasonable risk from TCE, hence, the term
``interim.'' Potentially exposed persons may continue to be at risk for
the developmental and immunotoxicity effects that provide the basis for
EPA's ultimate prohibition. Given the risk profile for TCE, EPA is
addressing the unreasonable risk through prohibition, and acknowledging
the critical or essential nature of several conditions of use affected
by providing reasonable timeframes and time-limited exemptions for a
TCE prohibition. A WCPP including the interim ECEL will be required as
an interim measure for each of the conditions of use listed in Unit
IV.C.
The requirement to meet an interim ECEL for the conditions of use
for which EPA is finalizing exemptions under TSCA section 6(g) is
supported by TSCA section 6(g)(4), which states that ``the
Administrator may impose conditions that are necessary to protect
health and environment while achieving the purposes of the exemption.''
EPA has determined the interim ECEL of 0.2 ppm is a condition that, as
explained in this Unit, allows for implementation and monitoring
feasibility, thus achieving the purposes of the exemption, while
providing health protectiveness for potentially exposed persons during
the duration of the TSCA section 6(g) exemptions. As a condition of the
exemption, it protects health by reducing exposure and thus risk
significantly: as stated previously, the interim ECEL will reduce
estimated baseline chronic workplace exposure by 97%.
For the conditions of use that continue for more than one year
subject to the interim ECEL but for which there is no TSCA section 6(g)
exemption, EPA also finds that the interim ECEL of 0.2 ppm and interim
action level of 0.1 ppm are necessary to reduce the risk during the
TSCA section 6(d) timeframe for those conditions of use. Throughout the
proposed rule and this final rule, EPA has emphasized the high risk
posed by TCE. Due to this risk, the proposed health protective air
exposure concentration (proposed ECEL) was so low that facilities would
encounter significant difficulty mitigating occupational exposures to
this level. Based on information in the 2020 Risk Evaluation (Ref. 1)
and on the extensive public comments, facilities would need to augment
their existing controls with unreasonably extensive use of burdensome
PPE. EPA determined reliance on extreme respiratory protection measures
is unlikely to mitigate the occupational risk of TCE, a view
corroborated by commenters. In particular, commenters noted that air
supplied respirators would present health and safety concerns for
workers due to their weight, bulk, impairment of hearing and vision,
and interference with use of other safety equipment (Refs. 34, 46, 29).
Respiratory protection is considered a last resort because respirators
cannot be worn by all persons, are not suitable for all situations, and
due to worker discomfort and fatigue, cannot be worn for long periods
of time. In addition, as discussed in this Unit, compliance with the
WCPP would be challenging; while specialized monitoring and analytical
methods are available for TCE in the low parts-per-billion range,
typical methods allow for detection in the 10 to 100 ppb (0.01 to 0.1
ppm) range. As a result, EPA determined that any measures short of
prohibition are insufficient to address the unreasonable risk from TCE.
2. Worker Protection Measures for Workers Disposing of TCE in
Wastewater to Industrial Pre-Treatment, Industrial Treatment, or
Publicly Owned Treatment Works
EPA proposed requirements to comply with the TCE WCPP for all
conditions of use that would continue for one year or more before
prohibition, as an interim measure to reduce exposures to TCE in the
workplace. As discussed in Unit III.A.1, numerous commenters stated it
would not be technically feasible to monitor to or
[[Page 102582]]
meet the proposed ECEL. Commenters emphasized that for wastewater
disposal, unlike a typical workplace where a WCPP could apply, work at
a cleanup site happens so intermittently that a regular monitoring
program would be extremely difficult to develop, requiring owners and
operators to implement sampling every time they were in the field.
Additionally, the WCPP requires additional monitoring to occur after a
change in workplace conditions as a commenter pointed out, which could
create a requirement for constant monitoring because cleanup sites are
dynamic systems (Ref. 43). In particular regarding the feasibility of
compliance with the WCPP, commenters associated with wastewater
disposal described that even with the maximum available engineering
controls, workers would have to rely on PPE of APF 10,000 to meet the
proposed ECEL at cleanup sites (Ref. 47).
As stated in Unit III.A.1, EPA recognizes the challenges of high
levels of respiratory protection which include, as described by OSHA,
communication problems, vision problems, worker fatigue, and reduced
work efficiency. Commenters involved in wastewater cleanup operations
were among those who submitted public comments in favor of an interim
exposure level that could be reliably measured using current analytical
methods (Ref. 33). Additionally, these commenters emphasized that
existing RCRA permits require HAZWOPER training for all employees who
are exposed or potentially exposed to hazardous substances at cleanup
sites. The HAZWOPER standard is a set of established policies,
practices, and procedures found in 29 CFR 1910.120. This standard is
designed to protect workers who may be exposed to hazardous substances
resulting from uncontrolled releases such as natural disasters,
equipment malfunctions, or other emergencies (Ref. 48). Operations that
fall within the scope of the HAZWOPER standard include cleanup
operations required by a government body and corrective actions
involving hazardous waste and sites covered by RCRA. Commenters also
provided information to EPA on the variety of remediation methods used
for TCE contaminated water and groundwater, noting a difference between
ex situ treatment systems that remove TCE-contaminated groundwater from
the ground, and in situ treatment systems that remediate the
groundwater in its place (Ref. 35). A commenter requested that the
HAZWOPER standard, currently implemented at thousands of clean-up
sites, should continue to be used instead of EPA's proposed WCPP (Ref.
45). Cleanup sites are dynamic systems that often involve multiple
chemical contaminants, and EPA agrees with commenters that the
structure and procedures under the HAZWOPER standard are best suited
for the unique worker protection scenarios at cleanup sites. However,
OSHA's PEL for TCE is 100 ppm as an 8-hour time-weighted average. See
29 CFR 1910.1000, Table Z-2. As discussed in the proposed rule, the
OSHA PEL has not been changed since the 1970s (Ref. 49).
For the purposes of the TSCA section 6(g) exemption from
prohibition for 50 years for disposal of TCE to industrial pre-
treatment, industrial treatment, or publicly owned treatment works for
the purposes of facilitating cleanup projects of TCE-contaminated water
and groundwater, based on public comments and coordination across
Federal programs, EPA has determined it is appropriate that owners and
operators of cleanup sites where potentially exposed persons are
involved in the disposal of TCE-contaminated water or groundwater for
the purposes of cleanup projects of TCE-contaminated water and
groundwater, including industrial pre-treatment and industrial
treatment activities, must ensure that potentially exposed persons
involved with the activity of removing the contaminated water or
groundwater from the location where it was found and treating the
removed contaminated water or groundwater on site continue to comply
with HAZWOPER requirements but with exposures for potentially exposed
persons limited to the interim ECEL for TCE (0.2 ppm as an 8-hr TWA,
for reasons discussed in Unit III.A.1.). Specifically, EPA has
determined that at cleanup sites, the TCE interim ECEL would apply to
any potentially exposed person involved in the disposal of TCE-
contaminated water or groundwater to industrial treatment, industrial
pre-treatment, or POTWs. A potentially exposed person most likely
includes a person who is involved with the activity of removing TCE-
contaminated water or groundwater from the location where it was found
and the on-site treatment of the TCE-contaminated water or groundwater.
EPA generally considers workers in and around those locations to be
potentially exposed persons as that term is defined is 40 CFR 751.5.
For example, EPA's requirements would apply to protect workers
conducting remediation through pump and treat systems or workers
sampling groundwater in conjunction with extraction or treatment (e.g.,
remediation or cleanup) activities. EPA considers treatment activities
that are performed at the cleanup site on TCE-contaminated wastewater
that has been removed from the subsurface, surface water impoundments,
or aquifers, and that are recognized as industrial treatment,
industrial pretreatment, or discharge to a POTW to be covered under the
provisions described in this unit. To further clarify, the workplace
protections for this exemption are not intended to cover potentially
exposed persons who may be exposed to TCE from other contaminated
media. Additionally, the workplace protections for this exemption are
not intended to cover potentially exposed persons who are sampling
groundwater to monitor the presence of a plume, but specifically only
those sampling wastewater at the site of extraction and active
treatment activities. EPA also notes that while the cross-referenced
OSHA regulations do not require the establishment of regulated areas,
the OSHA regulations do suggest excluding non-essential persons during
certain operations as a feasible work practice control.
For cleanup sites involved in the disposal of TCE-contaminated
water or groundwater to industrial treatment, industrial pre-treatment,
or POTWs, rather than implementing the monitoring, notification, and
exposure control plan requirements of the WCPP, in light of the special
circumstances of these sites, and the likely presence of multiple
contaminants, EPA is requiring compliance with the current requirements
in 29 CFR 1910.120 (HAZWOPER) except that for those provisions in 29
CFR 1910.120 that reference a PEL, owners and operators will instead
comply with the TSCA interim ECEL. EPA's requirement for cleanup sites
to meet specific existing OSHA health and safety requirements in 29 CFR
1910.120 combined with EPA's interim ECEL differs from the requirements
for the WCPP that will be in effect in other workplaces. EPA emphasizes
that this standard is only for cleanup sites involved in the disposal
of TCE contaminated groundwater and wastewater from cleanup sites under
the applicable condition of use and that no other remedial actions at
cleanup sites will be covered or affected. More specifically, EPA notes
that this rule only includes within its scope remediation methods that
would be considered industrial wastewater pretreatment, industrial
wastewater treatment or discharge to a POTW. As such, a remediation
method would need to be considered one of these three types of disposal
to fall within this condition
[[Page 102583]]
of use under TSCA, and if not would not be subject to the prohibition
or other requirements of the rule.
Similarly, some commenters asked EPA to clarify what responsibility
the receiver of waste, specifically POTWs, would have regarding
compliance with the WCPP and highlighted the challenges of the WCPP in
the context of POTWs, some of which may be outdoors and thus unable to
demarcate a regulated area in a straightforward way (Refs. 35, 45). EPA
emphasizes that disposal of TCE-containing wastewater to and from POTWs
is within the disposal condition of use. As exposures to TCE are likely
to continue in POTWs for the duration of the exemption for TCE disposal
under TSCA section 6(g) for industrial pre-treatment, industrial
treatment, or POTWs for the purposes of cleanup projects of TCE-
contaminated water and groundwater, and as EPA is interested in
reducing to the extent possible exposures to TCE during the time period
of this exemption, EPA proposed the WCPP as an appropriate measure.
However, under the proposal, the ECEL was so low that, as one commenter
stated, ``receivers of groundwater from cleanup sites would be forced
to assume that TCE is present, since it is not currently possible to
measure down to the ECEL'' (Ref. 45).
Even with a new interim ECEL, based on the public comments and
information reasonably available to the agency, EPA recognizes that
POTWs have more experience in water monitoring. As an example,
commenters described that TCE is measured in wastewater at POTWs as
water concentrations, not ambient air levels. Commenters described
regular water monitoring schedules of the concentration of TCE in
wastewater at the POTWs to which they disposed (Refs. 36, 50, and 51).
For this reason, in the final rule, POTW's must comply with either
solely the WCPP, or a water monitoring structure already more familiar
and implementable for POTWs as the initial screening before the WCPP in
the interim until prohibition.
To ease monitoring implementation, EPA has determined that POTWs
that can reasonably expect TCE to be present, because of existing
industrial users discharging into the POTW, will be able to determine
the need to comply with the WCPP by conducting an initial screening of
their wastewater. This approach follows EPA's 1992 ``Guidance to
Protect POTW Workers from Toxic and Reactive Gases and Vapors'' (Ref.
52) which sets wastewater screening levels for toxic chemicals using
Henry's Law constants to translate toxicity-based air exposure
concentrations to wastewater concentrations. This monitoring approach
also is consistent with water screenings described by several public
commenters (Refs. 36, 50, 51). The methodology assumes that wastewater
and air are in equilibrium, e.g., that the system is closed and water
agitation is negligible; that temperature is defined and constant; and
that other constituents in the wastewater do not affect a chemical's
volatilization to air.
The water screening requirement that EPA is finalizing follows the
methodology in the 1992 guidance, using the Henry's Law constant for
TCE (378 (mg/m\3\)/(mg/L) at 25 [deg]C) to calculate a screening level
for TCE in wastewater, 0.00284 mg/L, that corresponds to the interim
ECEL (0.2 ppm). This screening level is a level specific to TSCA, to
regulate unreasonable risk to workers performing wastewater disposal
that are exposed to TCE. This differs from maximum contaminant levels
(MCLs) which regulate public water systems under a different federal
statute and do not address exposures to TCE through wastewater. While
the screening level is lower than the current enforceable MCL for TCE
(0.005 mg/L), the values are within a factor of 2. EPA believes that
the conservative assumptions used to derive 0.00284 mg/L are
appropriate here because this is a screening approach, and the TCE
occupational exposure profile of wastewater workers may be variable.
If the concentration of TCE in wastewater received by a POTW is
less than or equal to the screening level, the POTW can assume that the
concentration of TCE in air that results from TCE volatilization from
wastewater is equal to or less than the interim ECEL. If a POTW's water
screening detects TCE in wastewater at a concentration greater than
0.00284 mg/L of TCE, then the WCPP is required. More information is in
Unit IV.E.
3. Exposure Monitoring Requirements
As part of the WCPP, EPA proposed to require that owners or
operators meet certain documentation requirements for each instance of
monitoring of TCE, including compliance with the Good Laboratory
Practice (GLP) Standards in accordance with 40 CFR part 792.
Numerous commenters expressed concern regarding the requirement
that the WCPP include compliance with the GLP Standards at 40 CFR part
792. Commenters stated that it is atypical to use this standard for air
sampling of TCE for industrial hygiene purposes (Refs. 39, 38).
According to the commenters, it is common practice within the
industrial hygiene community to have analyses performed by American
Industrial Hygiene Association (AIHA) accredited labs (Refs. 38, 39). A
commenter further reasoned that because labs in the United States are
certified by International Organization for Standards (ISO) and the
International Electrochemical Commission (IEC) standard 17025 (Testing
and Calibration Laboratories), a standard that differs from the
proposed GLP, they recommended that provisions of monitoring results
and recordkeeping in the final rule be allowed from any accredited
laboratory, without regard to a specific type (Refs. 38, 39).
EPA agrees with the commenters that the WCPP for TCE is
incompletely served by solely relying on the GLP standard as proposed.
EPA has considered laboratory capacity concerns raised by some
commenters (i.e., that potential increases in demand for professional
safety services and sampling laboratories may strain the broader
availability of laboratory service and result in sampling limitations
(Refs. 38, 39), and agrees that sufficient infrastructure must be in
place to ensure that the regulated community can successfully implement
the WCPP while TCE use is ongoing. For the final rule, EPA is requiring
that exposure samples be analyzed using an appropriate analytical
method by a laboratory that complies with the GLP Standards in 40 CFR
part 792 or that otherwise maintains a relevant third-party laboratory
accreditation (e.g., under the AIHA Laboratory Accreditation Programs,
LLC Policy Module 2A/B/E of Revision 17.3) or other analogous industry-
recognized programs. The laboratory must also retain related records.
Another commenter noted that EPA's proposal did not make clear that
``personal breathing zone'' air samples to monitor occupational
exposures are to be taken without regard to respirator use. More
specifically, the commenter pointed to the importance of EPA being
explicit that occupational monitoring only occurs in the absence of
respiratory protection (Ref. 29). EPA agrees with the commenter that
exposure monitoring should be conducted to reflect ambient occupational
conditions (i.e., without respiratory protection) to best inform
engineering control options and respiratory protection considerations
for potentially exposed persons. Therefore, the final rule now
explicitly states that occupational air sampling is required to measure
ambient concentrations for TCE without taking respiratory protection
into account when air sampling is performed. This will ensure the
highest degree of protection to potentially
[[Page 102584]]
exposed persons by requiring measurement of ambient air concentrations
of TCE, thus empowering owners or operators to appropriately consider
the hierarchy of controls.
Additionally, as part of the WCPP, EPA proposed to require owners
and operators to re-monitor within 15 working days after receipt of any
exposure monitoring if results indicated non-detect or air monitoring
equipment malfunction, unless an Environmental Professional, as defined
at 40 CFR 312.10, or a Certified Industrial Hygienist reviews the
monitoring results and determines re-monitoring is not necessary. EPA
received several comments disagreeing with the proposed requirement to
review non-detect air monitoring samples. The commenters stated that
the requirement is inconsistent with OSHA rules, is an unnecessary step
that adds no value to reduce risk to workers, and could be costly,
especially for smaller companies (Refs. 53, 54, 55, 47, 56, 57, 58).
One commenter suggested that EPA incorporate a six-sample rolling
average as the statistical evaluation would incorporate ongoing
validation of exposure levels for a particular task and thus remove any
need for resampling based on a non-detect result.
EPA disagrees with commenters that expressed the opinion that re-
evaluating non-detect results adds no value and is inappropriate. A
sampling result that is non-detectable does not necessarily imply
negligible occupational exposure to the chemical. A non-detect result
is indicative that the chemical was not detected by the particular
sampling and analytical procedures used at the time of sampling.
Multiple factors can contribute to a non-detect result. For example,
the chemical may simply not be present in appreciable quantities. An
alternative possibility is that the chemical is present at a level
below the limit of detection for the particular sampling and analytical
method used. Depending on the chemical and ambient conditions,
interference from another chemical during occupational sampling
sometimes results in an incorrect reporting of non-detectable levels.
This interference may or may not be known by the owner or operator at
the time of sampling, or by the laboratory at the time of analysis. It
is also possible that the owner's or operator's sampling technique or
the laboratory's analytical procedure was not particularly effective,
or that the chosen sampling and analytical method was not very
efficient or precise for the particular chemical of interest.
Therefore, re-evaluating non-detectable sampling results is often
appropriate and desirable. In each of the examples described in this
paragraph, a nondetectable sampling result, along with supporting
documentation about the sampling and analytical method used to get that
result, is a meaningful part of the potentially exposed person's
exposure record required under the WCPP. Monitoring results from
malfunctioning air monitoring equipment are not valid monitoring and
require resampling consistent with Sec. 751.315(b)(3)(i)(A) through
(D).
The provisions proposed for the WCPP did not require re-monitoring
in all cases. Re-monitoring may not be necessary based on a
professional evaluation by an Environmental Professional as defined at
40 CFR 312.10 or a Certified Industrial Hygienist. The final rule
provides flexibility in the event of a non-detect by allowing owners or
operators to either re-monitor or seek a determination from a qualified
professional that re-monitoring is not necessary. From an owner and
operator's perspective, a non-detect sampling result--when effective
sampling and analysis procedures are used--is valuable because it
suggests effective implementation of exposure controls. Potentially
exposed persons may also use these records in discussions with owners
and operators, in collective bargaining situations, or in compliance
assistance inquiries to EPA or other federal agencies. Exposure
monitoring results may also improve overall workplace health and reduce
owner and operator liability through effective detection, treatment,
and prevention of occupational disease or illness. All of these
scenarios are valuable for owners and operators, potentially exposed
persons, and for effective mitigation of occupational exposures. In
consideration of these factors, EPA has removed the air monitoring
equipment malfunction from the monitoring activities that do not
require resampling based on professional evaluation by an Environmental
Professional or Certified Industrial Hygienist. While professional
discretion may be warranted in determining whether re-monitoring is
needed following results that indicate non-detect, EPA has determined
this discretion is not appropriate in the event of air monitoring
equipment malfunction, which warrants re-monitoring. This is due to the
importance of air monitoring in ensuring that the requirements of the
WCPP are met, and the importance of the WCPP in reducing risks from
exposures to TCE in the workplace. Monitoring results from
malfunctioning air monitoring equipment are not valid monitoring.
Additionally, while statistical methods may be useful in
establishing and analyzing an occupational monitoring program, EPA
determined that information presented in support of amending the
evaluation of re-monitoring to rely on six sample rolling average of
exposure measurements in place of the proposal is not persuasive, as
discussed in detail in section 5.5.3 of the Response to Comments
document (Ref. 11). Occupational monitoring (and associated
recordkeeping) is a topic on which EPA may develop guidance as part of
final rule implementation efforts.
Therefore, based on consideration of public comment, EPA is
finalizing as proposed with slight modification the requirement to re-
monitor within 15 working days after receipt of any exposure monitoring
if results indicated non-detect, unless an Environmental Professional,
as defined at 40 CFR 312.10, or a Certified Industrial Hygienist
reviews the monitoring results and determines re-monitoring is not
necessary. EPA has modified the re-monitoring recordkeeping requirement
to clarify what would suffice as justification for when re-monitoring
is not necessary, and has therefore updated the recordkeeping
requirements associated with the WCPP exposure records required under
40 CFR 751.319(b)(1). EPA has also removed air monitoring equipment
malfunction from the monitoring activities that do not require
resampling if determined unnecessary by an Environmental Professional
or Certified Industrial Hygienist.
EPA proposed to require under the WCPP that each owner or operator
conduct additional exposure monitoring whenever a change in the
production, process, control equipment, personnel, or work practices
may reasonably be expected to result in new or additional exposures at
or above the ECEL action level, or when the owner or operator has any
reason to believe that new or additional exposures at or above the ECEL
action level occurred. In the event of start-up, shutdown, spills,
leaks, ruptures, or other breakdowns that may lead to employee
exposure, EPA proposed to require that each owner or operator conduct
additional initial exposure monitoring to potentially exposed persons
(using personal breathing zone sampling) after the cleanup of the spill
or repair of the leak, rupture, or other breakdown. EPA is finalizing
that requirement, with a compliance timeframe requiring that this type
of additional exposure monitoring must be conducted within
[[Page 102585]]
30 days (see Unit IV.C.4.d.), which is a change from the proposed rule,
in which a timeframe was not specified.
4. Designated Representatives
As part of the WCPP, EPA proposed to require that owners and
operators (i.e., any person who owns, leases, operates, controls, or
supervises a workplace covered by the rule) provide potentially exposed
persons or their designated representatives regular access to the
exposure control plans, exposure monitoring records, and PPE program
implementation and documentation. Additionally, EPA proposed to require
that owners or operators document the notice to and ability of any
potentially exposed person who may reasonably be affected by TCE
exposure to readily access the exposure control plans, facility
exposure monitoring records, PPE program implementation, or any other
information relevant to TCE inhalation exposure in the workplace.
EPA solicited and received public comments on the role of
designated representatives in the WCPP. One commenter, a group of labor
unions, urged EPA to incorporate requirements similar to OSHA's access
standard at 29 CFR 1910.1020 (entitled, ``Access to employee exposure
and medical records'') to ensure that exposure information is promptly
and fully shared with both potentially exposed persons and their
designated representatives (Ref. 29). The commenter also suggested that
EPA include a requirement that employers provide employees and their
designated representatives an opportunity to observe monitoring events.
The commenter observed that workers and their designated
representatives have a critical role to play in ensuring effective
control of toxic substances and further noted that, often, unions are
the organizations with expertise in understanding occupational exposure
information.
EPA recognizes the importance of having the ability for potentially
exposed persons and their designated representative(s), such as labor
union representatives, to observe exposure monitoring and have prompt
access to exposure records. EPA additionally recognizes that, in some
instances, individual workers may be hesitant to ask owners or
operators for information relating to their chemical exposure or may be
less familiar with discipline-specific industrial hygiene practices.
EPA determined that it is appropriate in this final rule to revise, to
some extent, the requirements regarding designated representatives
included in the proposed rule, consistent with existing OSHA precedent
in certain 29 CFR part 1910, subpart Z regulations, to allow designated
representatives the ability to observe occupational exposure monitoring
and have access to exposure monitoring records. The WCPP provisions of
the final rule include a requirement that owners and operators provide
potentially exposed persons or their designated representatives an
opportunity to observe any exposure monitoring that is designed to
characterize their exposures and is conducted under the WCPP. With
respect to facilities classified in the interest of national security,
only persons authorized to have access to such facilities must be
allowed to observe exposure monitoring.
The final rule also requires that designated representatives have
access to relevant exposure records, similar to provisions in certain
OSHA regulations under 29 CFR part 1910, subpart Z, such as 29 CFR
1910.1020. EPA is requiring owners and operators to notify potentially
exposed persons and their designated representatives of the
availability of the exposure control plan and associated records of
exposure monitoring and PPE program implementation within 30 days of
the date that the exposure control plan is completed and at least
annually thereafter.
EPA's definition of ``designated representative'' in 40 CFR 751.5
was established in the recently promulgated final rule under TSCA
section 6(a) that addresses the unreasonable risk presented by PCE (RIN
2070-AK84). This term means any individual or organization to whom a
potentially exposed person gives explicit, written authorization to
exercise a right of access. A recognized or certified collective
bargaining agent must be treated automatically as a designated
representative without regard to written authorization, analogous to
OSHA requirements set forth in 29 CFR 1910.1200. Additionally, with
respect to Federal Government employees, EPA, like OSHA at 29 CFR
1960.2(e), will interpret these designated representative requirements
consistent with the Federal Service Labor Management Relations Statute
(5 U.S.C. 71), or collective bargaining or other labor-management
arrangements that cover the affected employees.
Should a request be initiated for such records by the potentially
exposed person or their designated representative(s), the owner or
operator will be required to provide the specified records at a
reasonable time, place, and manner, analogous to OSHA requirements set
forth at 29 CFR 1910.1020(e)(1)(i). If the owner or operator is unable
to provide the requested records within 15 working days, the owner or
operator must, within those 15 days, inform the potentially exposed
person or designated representative(s) requesting the record of the
reason for the delay and the earliest date when the record can be made
available. Additionally, in the event that a designated representative
is observing exposure monitoring, the owner or operator must ensure
that designated representatives are provided with PPE appropriate for
the observation of monitoring. Finally, this rule requires owners or
operators to provide notice to potentially exposed persons and their
designated representatives of exposure monitoring results and of the
availability of the exposure control plan and associated records. For
purposes of this requirement, the owner or operator is only required to
provide notice to those designated representatives that the owner or
operator is aware of, such as representatives designated in writing or
a recognized collective bargaining agent for the owner or operator's
own employees.
5. Changes to WCPP Timeframes for Federal Agencies
EPA understands that certain departments and agencies of the
Federal government, as well as Federal contractors acting for or on
behalf of the Federal government, need additional time to comply with
these timeframes. For example, complying with these timeframes could
impact the ability of NASA or the Department of Defense to continue to
engage in vapor degreasing necessary for rockets key to national
security and critical infrastructure. While, for example, 29 CFR part
1960 sets forth procedures and guidelines for ensuring that Federal
workers are protected in comparable ways to their non-Federal
counterparts, EPA believes that compliance with this final rule will
require increased and different preparations on the part of Federal
agencies. For example, Federal agencies must follow procurement
requirements, which will likely result in increased compliance
timelines. In addition, these requirements will require support in the
Federal budget, which, for some agencies, is a multi-year process.
Therefore, EPA is providing additional time for agencies of the Federal
government and their contractors, when acting for or on behalf of the
Federal government, to comply with the WCPP, including 915 days for
initial monitoring, 1,005 days to ensure that no
[[Page 102586]]
person is exposed to an airborne concentration of TCE that exceeds the
interim ECEL, and 1,095 days to implement an exposure control plan.
B. Modifications to the TSCA Section 6(g) Exemptions
1. Industrial and Commercial Use of TCE as a Processing Aid in Battery
Separator Manufacturing
EPA proposed a 10-year exemption from prohibition under TSCA
section 6(g)(1)(B) for the industrial and commercial use of TCE as a
processing aid in battery separator manufacturing, for lead acid and
lithium batteries. EPA is finalizing with modifications a time-limited
exemption from prohibition for this specific condition of use of TCE.
These modifications, based on information provided in public comments,
include: (1) narrowing the exemption to apply only to use of TCE as a
processing aid in manufacturing separators for lead acid batteries; (2)
extending the time period of the exemption for lead acid batteries from
ten to 20 years; and (3) allowing the disposal of wastewater containing
TCE following lead acid and lithium battery separator manufacture under
a separate TSCA section 6(d) phase-out for disposal of TCE to
industrial pre-treatment, industrial treatment, or POTWs (see Unit
III.C.4.). Separate from the modified 6(g) exemption, EPA is finalizing
a 5-year phase-out under TSCA section 6(d) for use of TCE in
manufacturing separators for lithium batteries.
As described in the proposed rule, based on information provided by
commenters and other information reasonably available to the agency,
EPA understands that separators are fundamental components in batteries
that provide the necessary separation between the internal anode and
cathode components that make batteries work, and that restrictions on
the production of battery separators could critically impact the United
States battery manufacturing supply chain and impede the expansion of
domestic battery production capacity. EPA understands that battery
separator manufacturing processes are highly engineered, and that the
separators are specialty products designed precisely to meet stringent
technical specifications that are essential in powering vehicles and
systems in the United States' supply chain for multiple critical
infrastructure sectors.
Based on information provided in public comments regarding
specifications around the final battery separator product, such as the
required thickness of the separator itself and the feasibility of
substitute chemicals for TCE, EPA determined that battery separators
for lead acid and lithium batteries should be treated separately. Thus,
EPA is distinguishing between the industrial and commercial use of TCE
as a processing aid in battery separator manufacture for each type of
battery (lead acid or lithium (also referred to in comments as lithium-
ion batteries)) and providing different exemption or phase-out
timeframes for each type of battery separator manufacturing. More
details are in this Unit.
a. Lithium Battery Separator Manufacturing
EPA is finalizing a prohibition on the manufacture (including
import), processing, distribution in commerce, and industrial and
commercial use of TCE as a processing aid for lithium battery separator
manufacturing, which will come into effect 5 years after the
publication date of this rule. In response to EPA's proposal to
establish a 10-year TSCA section 6(g) exemption for the use of TCE in
battery separatory manufacturing, EPA received substantiative public
comments that described feasible alternatives to TCE in the manufacture
of lithium battery separators, as well as information on why the two
types of battery separator manufacturing should be treated as distinct.
One company uses TCE in the manufacture of lithium battery
separators (Ref. 46). In their public comment, the company described
how they could transition out of TCE within 5 years and retracted its
request for an exemption under TSCA section 6(g) for lithium battery
separators (Ref. 46). EPA is unaware of any other domestic manufacturer
that uses TCE to produce lithium battery separators. In public comments
on a separate rulemaking for methylene chloride under TSCA section 6,
at least five commenters described their plans to construct
manufacturing plants for lithium-ion battery separators, specifically
for electric vehicles, that would use methylene chloride as a
processing aid (Refs. 59, 60, 61, 62, 63, 64), rather than TCE. (The
final rule under TSCA section 6(a) to address the unreasonable risk for
the use of methylene chloride as a processing aid to continue with the
implementation of a WCPP (40 CFR 751.109) (89 FR 39254, May 8, 2024
(FRL-8155-01-OCSPP)).
TSCA section 6(d) requires the Agency to establish compliance
deadlines that are as soon as practicable. TSCA section 6(g) requires
that any exemptions be adequately justified. For the final rule, the
exemption under TSCA section 6(g) applies only to lead acid battery
separator manufacturing, and the Agency is prohibiting manufacture,
processing, and commercial use of TCE for the manufacture of lithium
battery separators after the five years specified under TSCA section
6(d). During the time before prohibition, manufacturers and processors
of TCE for use in the manufacture of lithium battery separators and the
users of TCE in the manufacture of lithium battery separators are
required to comply with the WCPP, as described in Units III.A., and
IV.C.
b. Lead Acid Battery Separator Manufacturing
EPA is finalizing a 20-year TSCA section 6(g) exemption from
prohibition for the manufacture (including import), processing,
distribution in commerce, and industrial and commercial use of TCE as a
processing aid for lead acid battery separator manufacturing. While EPA
proposed a 10-year section 6(g) exemption for the use of TCE in battery
separator manufacturing, in the primary alternative regulatory action
in the proposed rule EPA presented a 15-year exemption from the
prohibition on TCE for the industrial and commercial use of TCE as a
processing aid for battery separator manufacturing. EPA received
substantiative information in follow up meetings based on public
comments that 20 years would be the minimum timeframe needed to
transition to an alternative for manufacturing separators for lead-acid
batteries (Refs. 34, 39, 64, 65). While EPA received comments that more
than 20 years may be needed, for the reasons described in this Unit,
EPA is finalizing the exemption for use of TCE in manufacture of lead
acid battery separators at 20 years.
EPA emphasizes that alternatives to TCE in lithium battery
separator manufacturing are not expected to be feasible substitutes for
TCE in lead-acid battery manufacturing due to differences in the
processes for each separator type. This is primarily due to the
difference in thickness of the battery separators: lithium battery
separators are typically only 9 to 10 microns thick, while lead-acid
battery separators range from 6 to 50 times thicker than lithium
battery separators. Given the chemistry of the alternative solvent
reacting with the mineral oil and metal sheets that constitute the
process of manufacturing a battery separator, it would therefore
require between 225 to 625 times longer to physically extract lead acid
separators compared to lithium separators using an alternative solvent.
TCE is about 50% to 80% (depending
[[Page 102587]]
on temperature) more effective at extracting process oil during the
battery separator manufacturing process than the alternative product
used in the manufacturer's new lithium separator process (Ref. 64).
Overall, while alternatives to TCE are suitable for lithium battery
separator manufacturing and may be feasibly substituted in domestic
manufacturing within five years, these alternatives are not feasible
for lead acid battery separator manufacturing.
Numerous commenters submitted information on the use of TCE as a
processing aid in lead-acid battery manufacturing. Industry commenters
and trade associations involved in battery manufacture agreed that EPA
correctly categorized battery separator manufacturing as critical and
essential. In public comments, battery separator manufacturers
described the need for the exemption to be extended to 25 years, citing
the lack of a currently identified alternative and once identified, the
time necessary for testing and recertification for any alternatives to
TCE. As described by commenters, the steps for such a process include:
identifying and/or developing an alternative chemical as a processing
aid, sample trials, battery testing, second level battery testing,
changing battery separator production lines, and testing and production
approval processes from battery end users (e.g., automobile
manufacturers). This step-wise process is consistent with EPA's
understanding of developing and implementing alternatives for other
chemicals and uses. In follow-up conversations with battery separator
manufactures, EPA gained further clarity that timeframes could be
expedited somewhat, and on an expedited timeline would take 20 years
(Ref. 64). Because TSCA section 6(g) requires that any exemptions be
adequately-justified, in consideration of public input, and that the
period of the exemption is reasonable, EPA is lengthening the proposed
TSCA section 6(g) exemption from the prohibition for manufacture
(including import), processing, distribution in commerce, and use of
TCE in manufacturing separators for lead acid batteries from 10 years
to 20 years (i.e., to December 18, 2044.). EPA encourages manufacturers
of battery separators to identify early in their substitution efforts
if any further time would be needed.
2. Industrial and Commercial Use of TCE as a Processing Aid for
Specialty Polymeric Microporous Sheet Materials
EPA is finalizing a 15-year TSCA section 6(g) exemption from
prohibition for the manufacture (including import), processing,
distribution in commerce, and industrial and commercial use of TCE as a
processing aid for specialty polymeric microporous sheet materials.
While EPA proposed to prohibit industrial and commercial use of TCE as
a processing aid for specialty polymeric microporous sheet materials,
EPA's primary alternative regulatory action described a 15-year TSCA
section 6(g)(1)(A) exemption from prohibition for this use. EPA
received substantiative information in public comments to support
finalizing this exemption, as well as support for 15 years as the
appropriate timeframe for this exemption (Ref. 40).
As noted in the initial exemption request and in the public
comments submitted to EPA, specialty polymeric microporous sheet
materials are fundamental components in the production of critical or
essential products such as drivers' licenses, passports, and chemical
drum labels (Refs. 66, 40). EPA agrees that TCE is a critical and
essential component in the manufacturing process for these products.
EPA also agrees that certain applications of these specialty polymeric
microporous sheet materials are critical and essential uses for which
no technically and economically feasible safer alternative is
available. In public comments, the manufacturer of specialty polymeric
microporous sheet materials disagreed with EPA's proposal to restrict
the end uses of the specialty polymeric microporous sheet materials to
critical and essential products, stating that all end products of the
material use the same production line. EPA is finalizing with
modifications a time-limited exemption from prohibition for this
specific condition of use of TCE. These modifications, based on
information provided in public comments, include: (1) modifying the
exemption from the proposal to allow for this exempted use of TCE as a
processing aid to apply broadly to any end product; (2) allowing the
disposal of wastewater containing TCE associated with manufacture of
specialty polymeric microporous sheet materials under a separate TSCA
section 6(d) phase-out for disposal of TCE to industrial pre-treatment,
industrial treatment, or POTWs (see Unit III.C.4.); and (3), in an
effort to minimize worker exposure during the period of the exemption,
EPA is requiring that the industrial and commercial use of TCE as a
processing aid in the manufacture of specialty polymeric microporous
sheet materials can only continue at existing facilities already using
TCE to manufacture specialty polymeric microporous sheet materials. EPA
expects that development of any new facilities for the manufacture of
specialty polymeric microporous sheet materials could innovate new
processes that do not include use of TCE.
3. Industrial and Commercial Use of TCE in Batch Vapor Degreasing for
Essential Aerospace Parts and Components and Narrow Tubing Used in
Medical Devices
EPA is finalizing the proposed primary alternative 7-year TSCA
section 6(g)(1)(B) exemption from prohibition for industrial and
commercial use of TCE in batch vapor degreasing for essential aerospace
parts and components and 7-year TSCA section 6(g)(1)(A) exemption from
prohibition for industrial and commercial use of TCE in batch vapor
degreasing for narrow tubing used in medical devices. EPA received
substantiative information in public comments to support the need for
these exemptions. Based on the information received, EPA determined it
is necessary to finalize these exemptions.
Numerous commenters urged EPA to finalize the alternative
exemptions, citing strict safety and performance standards that TCE is
currently used to meet and a recertification process that would take a
longer timeframe than the 1 year that was proposed (Refs. 36, 43, 32,
56, 67, 43, 32, 56). Given that under this condition of use TCE is used
to clean parts for highly specialized end uses in the aerospace and
medical fields, commenters stressed that a significant length of time
would be needed for safety recertification of an alternative. These
commenters also described how all currently known potentially effective
drop-in substitutes to TCE for this highly specialized use are also
chemicals currently being evaluated or regulated by EPA under TSCA,
and, as such, they do not view these substitutes as viable long-term
alternatives to TCE. In many cases, according to commenters, the
transition to a TCE substitute would require the transformation or
complete replacement of complex equipment. One manufacturer indicated
in their public comments that they had identified an alternative that
could meet the cleanliness required for their end products; however,
using this substitute chemical solvent would also require changing to a
different machine type (i.e., to vacuum vapor degreasers). According to
that commenter, it would take seven years to install vacuum degreasers,
implement the necessary infrastructure upgrades, obtain permits, notify
customers, and validate existing
[[Page 102588]]
contracts (Ref. 36). EPA agrees that the significant amount of
infrastructure and equipment changes needed to transition out of TCE
for this specific vapor degreasing condition of use support finalizing
a longer timeline until prohibition.
Regarding section 6(g) criteria, commenters agreed with EPA's
characterization of TCE as being essential to meet unique cleanliness
demands for narrow tubing used in medical devices as well as for
aerospace parts. A public commenter noted the intensity of these safety
concerns particularly in medical tubing, noting that in implanted
devices ``manufacturing residues may `pose an inflammatory or
autoimmune trigger risk' that can lead to death'' (Ref. 36). For these
reasons, EPA is finalizing a time-limited exemption under TSCA section
6(g)(1)(A) for seven years for the industrial and commercial use of TCE
in batch vapor degreasing for narrow tubing used in medical devices,
and a time-limited exemption under TSCA section 6(g)(1)(B) for seven
years for the industrial and commercial use of TCE in batch vapor
degreasing for essential aerospace parts.
4. Industrial and Commercial Use in Closed-Loop Batch Vapor Degreasing
Necessary for Rocket Engine Cleaning by Federal Agencies and Their
Contractors
EPA proposed a 7-year TSCA section 6(g)(1)(B) exemption from the
prohibition on the industrial and commercial use of TCE as a solvent in
closed-loop vapor degreasing necessary for human-rated rocket engine
cleaning by NASA and its contractors, and the manufacture (including
import), processing, and distribution in commerce of TCE for this use.
EPA is finalizing with modifications the time-limited exemption from
prohibition for this specific condition of use of TCE. EPA received
information that this exemption should include all Federal agencies,
rather than just NASA, due to Federal agencies having similar critical
infrastructure and national security needs of rocket engines. Due to
the commonality of the United States' rocket engine industrial base,
other Federal agencies like NASA use TCE in the same condition of use
to support their rocket engine cleaning. EPA has made this change and
is finalizing a time-limited exemption under TSCA section 6(g)(1)(B)
for industrial and commercial use of TCE as a solvent in closed-loop
batch vapor degreasing necessary for rocket engine cleaning by Federal
agencies and their contractors.
C. Changes to Compliance Dates for Prohibitions Under TSCA Section 6(d)
EPA proposed a compliance timeframe of 1 year for the prohibitions
on industrial and commercial use of TCE and requested public comments
on the appropriateness of this timeline for specific conditions of use.
This unit describes modifications EPA made to proposed timeframes for
prohibitions under TSCA section 6(d) for the two conditions of use for
which EPA is finalizing different timeframes for prohibition. (Changes
to timeframes for proposed TSCA section 6(g) exemptions or
modifications of a section 6(g) exemption to a section 6(d) timeframe
are described in Unit III.B.). Given that the part of the rule
affecting the most significant volume of TCE is unchanged between
proposal and final, the overall impact of these changes is expected to
be minor.
1. Industrial and Commercial Use of TCE in Energized Electrical Cleaner
As described in this Unit, EPA is finalizing a prohibition in three
years for the industrial and commercial use of TCE in energized
electrical cleaner rather than the prohibition within 1 year as
proposed for this condition of use. EPA notes that energized electrical
cleaner is a sub-use of the industrial and commercial use of TCE as
solvent for aerosol spray degreaser/cleaner. During the timeframe
before prohibition, EPA is finalizing requirements to comply with
either specific prescriptive controls or the WCPP for the industrial
and commercial use of TCE in energized electrical cleaner, which is a
sub-use of the industrial and commercial use of TCE as solvent for
aerosol spray degreaser/cleaner, as described in Unit IV.D.1.
In the proposed rule, EPA solicited comment on whether some
activities would need longer compliance timeframes in order to
appropriately transition, and specifically mentioned uses such as
energized electrical cleaning, where TCE may be desired due to its low
flammability. EPA also requested comment on the feasibility and
appropriateness of the WCPP. EPA subsequently received several comments
expressing concern over the proposed prohibition on TCE in energized
electrical cleaner (Refs. 51, 68). In addition to describing the need
for additional time to transition to alternatives to TCE in energized
electrical cleaner, commenters described the work practices and context
that support the potential for exposure reduction to TCE through
workplace controls, including, but not limited to, the WCPP. For
example, one commenter described how energized electrical cleaners are
typically used only by professionals for specialized uses in which
strict workplace controls already exist (Ref. 51). As another example,
in a separate rulemaking under TSCA section 6 for PCE (RIN 2070-AK84),
one commenter described work practices and controls for use of
energized electrical cleaners, stating that facilities that require
cleaning of energized equipment rely on skilled technicians or other
professional users who typically have education and training that may
include two years at lineman school, time as an apprentice, licensing
or certifications, and continuing education (Ref. 69). The commenter
also stated that OSHA General Industry and Construction standards
include requirements specific to electrical work under 29 CFR part
1926, subparts E, K, and V. Commenters differed on whether the WCPP or
other workplace controls would be most suitable. Several commenters
stated that the WCPP would be impractical for use of TCE in energized
electrical cleaner because trained technicians often travel to
different facilities to conduct work, including facilities that may not
otherwise use a chemical for which the WCPP is required, and suggested
that instead of a WCPP, a training and certification program would be
sufficient to address the unreasonable risk (Refs. 51, 68).
Based on the information submitted to EPA as part of the comment
period regarding this condition of use, supported by subsequent
discussions for clarification, and in consideration of existing best
practices and regulations for work in electrical spaces as well as the
need for additional time to certify and transition to substitutes, EPA
is finalizing a prohibition on the use of TCE in energized electrical
cleaner after December 18, 2027. In addition, EPA has determined that
either the WCPP or specific prescriptive controls specified in the
final rule, including dermal PPE and respiratory protection, are
necessary and appropriate for reducing exposures to potentially exposed
persons until the prohibition takes effect.
EPA notes the importance of existing OSHA regulations designed to
protect workers exposed to dangers such as electric shock,
electrocution, fires, and explosions. Specifically, in addition to the
requirements for electrical work under OSHA General Industry and
Construction standards at 29 CFR part 1926, subparts E, K, and V that
one commenter mentioned in their public comment, OSHA regulates
electrical work under Occupational Safety and
[[Page 102589]]
Health standards at 29 CFR part 1910. For example, OSHA requires
safety-related work practices on electrical equipment under the
Electrical Standard at 29 CFR part 1910, subpart S (29 CFR 1910.301 to
1910.399), which was significantly updated in 2007 (72 FR 7136,
February 14, 2007). OSHA also sets forth requirements for the operation
and maintenance of electrical power generation, control,
transformation, transmission, and distribution lines and equipment
under the Electric Power Generation, Transmission, and Distribution
standard at 29 CFR 1910.269, which was significantly updated in 2014
(79 FR 20316, April 11, 2014). Additionally, OSHA regulates electrical
protective equipment under the Electrical Protective Equipment standard
at 29 CFR part 1910, subpart I (29 CFR 1910.137), which was
significantly updated in 2014 (79 FR 20316, April 11, 2014). Other
standards and best practices apply to electrical safety in the
workplace, for example the National Fire Protection Association (NFPA)
70E Standard for Electrical Safety in the Workplace (Ref. 70).
As discussed in the proposed rule, given the risk profile of TCE,
EPA determined that it is necessary to require worker protection
measures such as the WCPP for those conditions of use that will
continue beyond 1 year. In view of the relatively short timeframe for
transitioning to an alternative, combined with the specialized nature
of this use of TCE and the existing OSHA regulations and other best
practices for performing work on energized equipment, EPA recognizes
that the WCPP may not be the best approach to addressing occupational
exposures in the interim. EPA understands that trained technicians
performing this activity often travel to different facilities to
conduct their work, including facilities that may not otherwise use
TCE. EPA also determined that owners and operators who perform this
kind of work should focus their efforts on transitioning to
alternatives, rather than setting up comprehensive exposure control
plans and programs. EPA is therefore providing an alternative to the
WCPP in the form of prescriptive controls, including respiratory and
dermal protection to protect workers in the interim. Considering all of
these factors, as well as the workplace requirements for energized
electrical cleaner in the final regulation of PCE under TSCA section 6
(RIN 2070-AK84) and the burdens associated with higher APF respirators,
EPA has determined that the use of respirators with an APF of 50 or
greater and impermeable gloves will minimize the exposure to the
potentially exposed persons engaged in this use of TCE during the
interim period before the prohibition takes effect, as further
described in Unit IV.D. In addition, requiring PPE similar to that
required by the PCE regulation is expected to ease the transition to
PCE, which is a possible replacement for TCE in these products. The
upstream manufacturing and processing of TCE for the use in energized
electrical cleaner will be subject to the WCPP as described in Unit
IV.C. until the use is prohibited.
EPA emphasizes that other industrial and commercial use of TCE as a
solvent for aerosol spray degreasers/cleaners is prohibited in the
final rule, consistent with the proposal for that condition of use.
2. Industrial and Commercial Use in Adhesives and Sealants for
Aerospace Applications
EPA is finalizing a prohibition in five years for the industrial
and commercial use of TCE in adhesives and sealants for aerospace
applications. EPA proposed a compliance timeframe of 1 year for the
prohibitions on industrial and commercial use, and in public comments
requested feedback on the appropriateness of this timeline for specific
applications. EPA received public comments highlighting that the
industrial and commercial use of TCE in adhesives and sealants
specifically for aerospace applications has safety implications and
involves longer recertification timelines (Ref. 56). EPA's rationale
for the short timeframe until prohibition for this condition of use was
based on the understanding that alternative formulations or products
exist that do not contain TCE. During the public comment period, EPA
received public comments highlighting the safety considerations for
industrial and commercial use of TCE in adhesives and sealants
specifically for aerospace applications and longer recertification
timelines. A public commenter stated that TCE is still critically
necessary in adhesives and sealants; particularly in aircraft pneumatic
deicing boots; in solvent bonding of plastic components, including on
Oxygen Container Assemblies for Passenger Service Unit products used in
aircraft; and as an adhesive or sealant for flight-critical equipment
on new and existing aircraft, both commercial and military (Ref. 56).
Regarding compliance timeframes, this commenter requested that
adhesives and sealants for aerospace be allowed to continue in
perpetuity under a WCPP. EPA has determined that prohibition of this
use is necessary to address the unreasonable risk. EPA did consider the
information raised by this commenter in determining an appropriate
timeframe for the prohibition on use of TCE in adhesives and sealants
for aerospace applications. Specifically, the commenter provided
information that for uses in the aerospace and defense sector, changes
in response to a prohibition on TCE would be a multiyear process that
requires redesign and recertification that a product meets performance
standards such as customers' technical requirements, UL and
Conformit[eacute] Europ[eacute]enne (CE) marking requirements, military
specifications, and specifications from other government agencies such
as the Federal Aviation Administration and NASA (Ref. 56).
EPA recognizes that the recertification process for uses in
aerospace applications is lengthy and agrees that one year is not a
sufficient timeframe. In identifying a reasonable timeframe, EPA
considered public comments on the proposed rulemaking and follow-up
clarifying conversations with commenters, as well as information
submitted during the public comment period on EPA's proposed rule under
TSCA section 6 for methylene chloride (88 FR 28284, May 3, 2023 (FRL-
8155-02-OCSPP)) regarding anticipated timeframes to recertify adhesives
and sealants used in the aerospace field. As such, EPA has determined
that a 5-year timeframe until prohibition for the industrial and
commercial use of TCE in adhesives and sealants for aerospace
applications is appropriate and will be sufficient to allow for a
reasonable transition from TCE. During this time, EPA is requiring
compliance with the WCPP, as detailed in Unit IV.C. The issuance of
this final rule does not preclude these users from presenting
additional information to EPA on their redesign and recertification
progress in the future.
3. Industrial and Commercial Use of TCE in Laboratory Use for Asphalt
Testing and Recovery
EPA is finalizing a phase-out of ten years for the industrial and
commercial use of TCE in laboratory use for asphalt testing and
recovery, with a prohibition on use of TCE in manual centrifuge
processes at 5 years. In the proposed rule, EPA proposed to prohibit
the laboratory use of TCE (which falls within the condition of use
``Industrial and commercial use of TCE in hoof polish; gun scrubber;
pepper spray; and other miscellaneous industrial and commercial uses'')
within 1 year. EPA proposed a TSCA section 6(g)(1)(A) exemption from
prohibition for the
[[Page 102590]]
industrial and commercial use of TCE in laboratory use for essential
laboratory activities that are critical (e.g., occupational sampling
and monitoring, the support of environmental cleanup activities, wax
removal from NASA infrared sensors, and equipment calibration related
to the search for chlorinated hydrocarbons on Mars; for a full list of
critical activities see Unit V.A.3.a.iii. of the 2023 TCE proposed
rule). In the 2023 TCE proposed rule, EPA specifically noted that the
use of TCE in laboratory settings for testing asphalt would not be
included in the TSCA section 6(g) exemption due to information
available to EPA that indicated it was not critical nor essential, and
because alternative testing methods exist, including the Nuclear
Asphalt Content Gauge and the Ignition Method.
During the public comment period, EPA received numerous comments
providing new information on the importance of TCE in asphalt testing
and recovery as a laboratory use, and the challenges of using a
substitute that had appeared theoretically feasible. Many commenters,
including several state departments of transportation, emphasized to
EPA that 23 state specifications require TCE to be used for solvent
extraction for asphalt testing accuracy (Refs. 55, 57, 58, 71, 72, 73,
74, 75, 76, 77). Commenters described how this use of TCE is critical
or essential; specifically, numerous commenters emphasized that in the
current landscape for asphalt testing and recycling, TCE is widely used
at this time because it can be easily recovered and the asphalt test
sample can then be reused rather than discarded. Further, as commenters
described, using TCE in laboratory testing allows departments of
transportation to recycle asphalt paving and shingles into new asphalt
by determining how much asphalt binder is present. The ability to
determine the amount of remaining asphalt binder has resulted in,
according to commenters, asphalt being one of the most recycled
materials. The Nuclear Asphalt Content Gauge that EPA had identified as
an alternative in the proposed rule does not allow for asphalt
recycling, as it destroys the asphalt sample during the test which
makes it impossible to test the asphalt binder as well.
In consideration of public comments, EPA has determined that a
prohibition after 1 year is not reasonable. States are currently
invested heavily in extraction equipment that uses TCE and EPA agrees
with commenters who stated that transitioning from TCE would take years
and incur significant costs as a result of equipment changes.
Commenters expressed an interest in ceasing their use of TCE and
requested between 5 years and 20 years until prohibition of this use of
TCE in order to facilitate a transition away from TCE. In determining a
reasonable timeframe for a phase-out, EPA considered significant
information provided in public comments about the potential
alternatives to TCE in laboratory asphalt testing that would allow for
testing as well as recovery. While alternatives have already been
identified, fully implementing use of those substitutes would require
the complete retrofit of existing laboratory equipment. Additionally,
numerous state departments of transportation standards would need to be
updated, which would take time.
EPA does not view the 50-year timeframe proposed (and finalized)
for the exemption for laboratory use of TCE for essential laboratory
uses as appropriate for use of TCE in asphalt testing and recovery, so
is not finalizing the laboratory asphalt testing and recovery use as
part of the TSCA section 6(g) exemption for essential laboratory
activities. Based on public comments and discussions with the U.S.
Department of Transportation, EPA has determined that 10 years is a
reasonable timeframe until the prohibition on TCE use in laboratory use
for asphalt testing and recovery and is finalizing an extended phase-
out of ten years for the industrial and commercial use of TCE in
laboratory use for asphalt testing and recovery. Associated with this
phase-out, EPA will require the establishment of the TCE WCPP, outlined
in Unit IV.C. within 180 days after publication of the final rule, as
workplace protections during the period of the phase-out. Additionally,
EPA has identified asphalt testing and recovery conducted through
manual centrifuge methods as specific activities that would be
prohibited within five years as part of the phase-out, due to the
higher level of worker exposure from this activity and information
received from commenters about automated alternatives.
In public comments, numerous users of TCE for asphalt testing and
recovery provided information to EPA regarding technological advances
in this sector--namely the transition from manual centrifuge methods of
testing to automated machines (Refs. 71, 72, 57). Many laboratories
have invested in automated extraction machines. These machines are
expensive and currently are calibrated to be chemical-specific, with
TCE-calibrated machines unable to use a different or replacement
solvent, such as PCE (Refs. 71, 72, 55). EPA's identification of a 10-
year timeframe for prohibition is partly based on the time it would
take to replace or retrofit the current laboratory practices with non-
TCE automatic extraction machines.
Based on public comments, EPA understands that the industry favors
automated extraction machines due to the extremely high worker
exposures inherent with manual centrifuge processes. Commenters
describe manual centrifuge processes as resulting in worker exposure to
TCE for the entire task duration, with constant handling of the solvent
by stirring, repouring, straining, and vaporizing it at times (Ref.
71). EPA agrees with commenters on the high risk of asphalt testing and
recovery using TCE in manual methods. As such, as part of the phase-
out, any lab use of TCE for asphalt testing or recovery which uses
manual centrifuge processes is prohibited in 5 years. Between 5 and 10
years, labs must either use TCE in automated machines only, or use
alternative solvents in automated machines or manual centrifuge
processes (such as methylene chloride or PCE, for which EPA has
finalized provisions requiring chemical specific WCPPs). Therefore, EPA
is finalizing an extended phase-out of ten years for the industrial and
commercial use of TCE in laboratory use for asphalt testing and
recovery, with a prohibition on use of TCE in manual centrifuge
processes at 5 years, rather than the prohibition within 1 year as
proposed for all other industrial and commercial uses without extended
phase-outs or exemptions.
4. Disposal of TCE to Industrial Pre-Treatment, Industrial Treatment,
and POTWs
For disposal of TCE to industrial pre-treatment, industrial
treatment, and POTWs, EPA is finalizing a phase-out over 20 years. In
the proposed rule, EPA proposed to prohibit the disposal of TCE to
industrial pre-treatment, industrial treatment, and POTWs in 1 year
after the rule finalization. In the proposal, EPA requested comment on
whether the prohibition timeframes and compliance dates were
appropriate. In public comments, EPA received substantive information
from several industrial and commercial users of TCE as a processing aid
that wastewater disposal should continue on a timeframe to facilitate
those uses.
Commenters manufacturing battery separators provided details on why
the industrial and commercial use of TCE in battery separator
manufacturing necessitates the disposal of wastewater containing TCE
(Refs. 46, 34). As described by commenters, in battery separator
manufacturing, TCE enters the
[[Page 102591]]
wastewater stream following contact between cooling tower blowdown,
processes involving TCE, and water generated from the plant's steam
distillation process, which is a key process step in battery separator
manufacture. Water used in these processes becomes wastewater
containing TCE. These manufacturers perform on-site treatment of this
wastewater through air stripping and carbon absorption. The pre-treated
water is then either recycled and reused in the process or discharged
to a POTW. Wastewater discharges by battery separator manufacturers are
regulated under existing wastewater discharge permits and have limits
for volatile organic compounds such as TCE. EPA agrees with commenters
assertions that TCE wastewater is inherently leftover as part of the
process and agrees that no other form of disposal is acceptable. Given
that the generation of wastewater containing TCE cannot be avoided as
it results from an intrinsic component of battery separator
manufacture, and EPA's determination that use of TCE in battery
separator manufacture is either a critical and essential function for
which there is no technically or economically feasible safer
alternative (in the case of lead acid batteries) or for which five
years before prohibition is as soon as practicable (in the case of
lithium batteries), EPA is modifying the associated timelines for the
prohibition on disposal for these uses, with worker protections, to
continue disposal of wastewater containing TCE that is a necessary part
of this process.
Based on public comments, EPA also finds that disposal of
wastewater is a necessary part of the use of TCE as a processing aid in
the manufacture of specialty polymeric microporous sheet materials.
Like the battery separator manufacturers, comments submitted from the
specialty polymeric microporous sheet materials manufacturer explained
that TCE enters the facility wastewater that is generated in cooling
tower blowdown water and subsequently discharged to a POTW (Ref. 40).
Wastewater discharges are regulated under existing wastewater discharge
permits and have limits for volatile organic compounds such as TCE.
Given the determination of the critical and essential need for the
longer timeframes for this industrial and commercial use, EPA is
modifying the TSCA section 6(d) phaseout for disposal of TCE for this
use to allow disposal of wastewater containing TCE that is a necessary
part of this process.
As such, the disposal of TCE to industrial pre-treatment,
industrial treatment, and POTWs is prohibited with the following phase-
out structure. For the majority of industrial and commercial uses, such
disposal is prohibited at one year. For industrial and commercial users
of TCE as a processing aid in lithium battery separator manufacturing,
such disposal is prohibited at 5 years. For industrial and commercial
users of TCE as a processing aid in specialty polymeric microporous
sheet materials manufacturing, such disposal is prohibited after 15
years. For industrial and commercial users of TCE as a processing aid
in lead-acid battery separator manufacturing, such disposal is
prohibited after 20 years. Industrial and commercial users who are
allowed to continue disposing of TCE to wastewater for more than one
year must follow the WCPP provisions as laid out in Unit IV.C, and
POTWs receiving wastewater must follow the wastewater worker protection
provisions discussed in Unit IV.E.3.
5. Industrial and Commercial Use of TCE for Batch Vapor Degreasing for
Land-Based DoD Defense Systems by Federal Agencies and Their
Contractors
EPA is finalizing a prohibition in five years for the industrial
and commercial use of TCE in batch vapor degreasing for land-based DoD
defense systems by Federal agencies and their contractors. EPA proposed
a compliance timeframe of one year for the prohibitions on industrial
and commercial use of TCE in vapor degreasing. EPA received information
indicating that this use needs to continue for a longer period of time
due to the national security implications of the end products, and the
need for a reasonable transition period for that use that is as soon as
practicable but longer than the one year proposed. TCE vapor degreasing
is necessary due to technical challenges with other substitute
chemicals or alternative methods. The cleanliness standards of certain
parts as required by DOD specifications or other specifications
included in existing contracts within the supply chain currently
require TCE. A reasonable transition period for this technically
challenging use requires substantial investment and time to develop
viable alternatives, because conversion from vapor degreasing to other
methods of cleaning is a capital-intensive investment that would
require several years to plan, permit, construct, and install. TCE has
been used in vapor degreasing to meet required levels of cleanliness of
certain supplied parts by long-standing design specifications that are
incorporated into contracts of a complex supply chain. As such, the
industrial and commercial use of TCE for batch vapor degreasing for
land-based DoD defense systems is prohibited after 5 years, rather than
at 1 year with vapor degreasing for other purposes.
D. Other Changes
1. Regulatory Threshold
In the 2023 TCE proposed rule, EPA requested comment on whether the
Agency should consider a de minimis threshold of TCE in formulations
when finalizing prohibitions, and, if so, what threshold should be
considered. EPA received comments in support of the inclusion of a de
minimis threshold, as well as comments opposing such a threshold. Of
the supportive commenters, many agreed with the EPA request for comment
on using 0.1% by weight as the threshold for the applicability of
prohibitions and restrictions on TCE (Refs. 53, 78, 51), which EPA is
referring to in this final rule as a regulatory threshold. Commenters
provided a variety of reasons in support of a regulatory threshold,
such as the difficulty of proving the absence of a chemical (Refs. 38,
79) and the importance of providing for very small amounts of a
chemical that cannot be reasonably eliminated (Ref. 37). Commenters
observed that TCE is unintentionally manufactured as a byproduct in
small amounts in the manufacture of chlorinated organics and noted that
this cannot be prevented in the production process (Ref. 39). In some
cases, commenters noted that a 0.1% threshold would be consistent with
the requirements under the OSHA Hazard Communication Standard at 29 CFR
1910.1200 (Refs. 78, 51). One of these commenters observed that,
because levels below 0.1% are not required to be reported on Safety
Data Sheets (SDSs) under the OSHA Standard, there is likely to be a
lack of awareness of products that contain TCE below this level.
To aid the regulated community with implementing the prohibitions
on TCE and to account for TCE as a byproduct or impurity in products,
EPA is establishing a regulatory threshold of 0.1% for TCE, indicating
that TCE at concentrations less than 0.1% by weight are not subject to
the prohibitions and restrictions outlined in this rulemaking. EPA
views the regulatory threshold as an appropriate policy approach
necessary to aid in the rule implementation and to clarify which
products are subject to the final rule. As defined in 40 CFR 751.5,
``product'' means ``the chemical substance, a mixture containing the
chemical
[[Page 102592]]
substance, or any object that contains the chemical substance or
mixture containing the chemical substance that is not an article.''
This 0.1% regulatory threshold for TCE is in alignment with
Appendix A of 29 CFR 1910.1200 Health Hazard Criteria developed by
OSHA; OSHA described this threshold in the 2012 modifications to the
hazard communication standard: ``When data on the mixture as a whole
are not available, the mixture is considered to present the same health
hazards as any ingredients present at a concentration of 1% or greater,
or, in the case of carcinogens, concentrations of 0.1% or greater. The
current HCS [hazard communication standard] also recognizes that risk
may remain at concentrations below these cut-offs, and where there is
evidence that that is the case, the mixtures are considered hazardous
under the standard.'' (89 FR 44144, May 20, 2024). Under 29 CFR
1910.1200, a health hazard is defined as ``a chemical which is
classified as posing one of the following hazardous effects: acute
toxicity (any route of exposure); skin corrosion or irritation; serious
eye damage or eye irritation; respiratory or skin sensitization; germ
cell mutagenicity; carcinogenicity; reproductive toxicity; specific
target organ toxicity (single or repeated exposure); or aspiration
hazard.'' The criteria for determining whether a chemical is classified
as a health hazard are detailed in Appendix A to 29 CFR 1910.1200--
Health Hazard Criteria. Appendix A.6.3.1 and A.7.3.1.1 of 29 CFR
1910.1200 indicate that a mixture must be classified as a carcinogen or
a reproductive toxicant, respectively, if it includes greater than or
equal to 0.1% of a substance that, like TCE, is classified as a
carcinogen or a reproductive toxicant. Other EPA programs, such as the
Toxics Release Inventory (TRI) program, have adopted the OSHA threshold
of 0.1% for chemicals which are defined as carcinogens or as a
potential carcinogen under the National Toxicology Program,
International Agency for Research on Cancer, or OSHA (see 40 CFR
372.38(a)).
EPA is finalizing a regulatory threshold of 0.1% so that products
containing TCE at concentrations less than 0.1% by weight are not
subject to the prohibitions and restrictions of this final rule. EPA is
finalizing this threshold for many of the reasons stated by commenters,
such as the difficulty of proving the absence of a chemical (and the
resulting uncertainty in various supply chains), the fact that the
manufacture of chlorinated organics results in the unintentional
manufacture of small amounts of TCE (and other chlorinated compounds)
as a byproduct that becomes an impurity that is not feasible to remove,
and the fact that it would be consistent with the OSHA Hazard
Communication Standard and other programs to which industry has already
calibrated its processes. EPA believes that adopting a regulatory
threshold of 0.1% for TCE, which is a carcinogen and a reproductive
toxicant, will increase regulatory certainty and ease implementation of
the eventual prohibition of this chemical. This regulatory threshold is
well below the concentration used for any products that contributed to
the unreasonable risk. By prohibiting TCE concentrations of 0.1% or
greater in products, EPA prevents any functional uses of TCE, which
generally rely on a higher concentration of the chemical in order to
make use of TCE's chemical properties. The manufacture (including
import), processing, and distribution in commerce of products that
contain TCE at concentrations equal to or above the regulatory
threshold of 0.1% are still subject to the prohibitions and
restrictions of this final rule, regardless of the concentration of TCE
in the end product.
2. Processing of TCE Manufactured as a Byproduct
In the 2023 TCE proposed rule, EPA noted that TCE that is
manufactured as a byproduct (such as during the manufacture of other
chemicals, e.g., 1,2-dichloroethane (1,2-DCA)) is not considered to be
within the condition of use of TCE manufacturing. EPA has not changed
this determination. However, in the 2023 TCE proposed rule, EPA did
consider processing (including reuse) of TCE that was manufactured as a
byproduct to be under the processing as a reactant/intermediate
condition of use of TCE. Specifically, in Unit III.B.1.b.i. of the 2023
TCE proposed rule (``processing as a reactant/intermediate''), EPA
noted that ``this condition of use includes reuse of byproduct or
residual TCE as a reactant.'' EPA received numerous public comments on
how the proposed rule addressed TCE as a byproduct that was then
processed, with several commenters providing detailed information on
how TCE is unintentionally manufactured as a byproduct during complex
chemical processing streams and then processed and re-processed within
those streams alongside other, similar chemicals (Refs. 42, 80, 39, 81,
and 56). For clarity, EPA is using the terms reuse, recycling, and re-
processing within this section as specifically used by commenters to
refer to actions that occur under the larger condition of use of
``processing.'' One commenter pointed out that without excluding from
the prohibitions any subsequent processing of TCE manufactured as a
byproduct, chemical facilities would experience significant disruptions
when trying to isolate and remove the TCE that was unintentionally
manufactured, and that would otherwise be processed and consumed (Ref.
43). This commenter also emphasized the anticipated negative waste and
upstream production impacts from a prohibition on the reuse of TCE
manufactured as a byproduct, and highlighted how TCE is produced in the
1,2-DCA manufacturing process and how it is processed and recycled in
the reactor manufacturing process for PCE and carbon tetrachloride
(CTC). This commenter highlighted that if TCE byproduct processing was
prohibited, this would significantly increase the quantity of hazardous
waste disposed of and increase the use of virgin raw material in
chemical manufacturing (Ref. 43). The commenter also provided a
description of controls in place at chlorinated organic facilities to
mitigate risk associated with TCE byproduct creation and recycling as
well as citations to communications with EPA regarding these processes
(Ref. 43).
As described in more detail in the Response to Comments document
(Ref. 11), EPA agrees with commenters that TCE manufactured as a
byproduct should logically be able to be processed, including recycled,
during or concurrent with the processing of the intended manufactured
chemical substance(s) so long as the TCE is processed in a site-
limited, physically enclosed system within the same reaction process.
EPA also recognizes the significant risks to workplace safety if all
facilities manufacturing TCE as a byproduct had to distill, remove, and
destroy all traces of TCE before further chemical processing could
commence. For this reason, EPA is excluding from this rule the
processing of TCE as a byproduct when that byproduct TCE is processed
within a site-limited, physically enclosed system that is part of the
same overall manufacturing process from which the byproduct substance
was generated. In this rule, EPA is incorporating the definition of
``site-limited'' in 40 CFR 711.3 and also aligning with the description
of site-limited, physically enclosed systems in 40 CFR 711.10(d)(1),
which identifies activities for which reporting on certain byproducts
is not required under the CDR Rule.
In proposing the CDR definition, EPA described enclosed systems for
the purposes of CDR as system of
[[Page 102593]]
equipment directly connected to the production process that is
designed, constructed, and operated in a manner which prevents
emissions, or the release of any chemical substance into the facility
or environment during the production process. (84 FR 17692, April 25,
2019) (FRL-9982-16). Such emissions, including fugitive emissions,
could lead to exposures to workers, the public, or the environment. For
an enclosed system, exposure and release could only occur due to loss
of integrity or failure of the manufacturing process equipment or
control systems. To meet the EPA enclosed system scenario, any
equipment that the byproduct is present in at any point during the
process sequence, such as tanks, reaction vessels, reactors, processing
units (e.g., a drum filter), and/or connecting lines, must: (1) Be of
high structural integrity and contained on all sides, (2) pose no
foreseeable potential for escape of constituents to the facility or
environment during normal use, and (3) be connected directly by
pipeline or similarly enclosed device to a production process. Also,
any transfers or holding steps occurring in this system must be
necessary to the recycle process and must take place within physically
enclosed equipment that meet the enclosed system scenario. For example,
hard piping or completely sealed (i.e., welded) equipment would meet
these criteria if connected directly to other enclosed equipment,
preventing potential releases including fugitive emissions.
EPA is finalizing an exclusion from this rule for TCE manufactured
and then processed as a byproduct in a site-limited, physically
enclosed system that is part of the same overall manufacturing process
from which the byproduct TCE was generated. EPA plans to interpret the
exclusion for processing byproduct TCE in this rule in a similar way as
the exemption for certain byproducts from CDR.
EPA recognizes the concerns that other commenters raised regarding
potential risks from TCE manufactured as a byproduct; several
commenters stated that rather than expand exclusions for TCE
manufactured as a byproduct, EPA should evaluate all aspects of
manufacture of a chemical substance and that byproducts could pose a
risk to fenceline communities (Refs. 44, 30). As described in the
proposed rule, EPA is including the evaluation of TCE manufactured as a
byproduct during the manufacture of 1,2-DCA in the risk evaluation for
1,2-DCA. Additionally, unless it is for the purposes of disposal (see
Unit IV.C.1.d.), TCE that exits the site-limited, physically enclosed
systems in which it was manufactured by removal from the system, by
relocation, or by conclusion of the manufacturing process is subject to
the restrictions, prohibitions, and other provisions of this final
rule. EPA notes that for the manufacturing of two chemicals, PCE and
CTC, which may produce TCE as a byproduct within site-limited,
physically enclosed systems, EPA is requiring a WCPP for PCE or CTC,
which would provide a level of protection from TCE for potentially
exposed persons while addressing the unreasonable risk from PCE or CTC.
EPA received additional information from a chemical manufacturer
(Ref. 82) that manufactures TCE as a byproduct during other processes
and then sends the TCE offsite for RCRA hazardous waste disposal. EPA
notes that in the Risk Evaluation for TCE, EPA explained that it had
tailored the scope of the risk evaluation to exclude the disposal
pathway of TCE, except for limited disposal of TCE-containing
wastewater discussed in Unit IV.B.6. Thus, the disposal of TCE and the
processing and distribution in commerce for such disposal is out of
scope for this rule unless otherwise specified. EPA understands that
some facilities, such as those that produce substances critical to the
battery supply chain, may manufacture TCE as a byproduct and that TCE
is not further processed onsite but rather is disposed of offsite. Such
activity is not covered by this rule.
3. Industrial and Commercial Use of TCE as a Solvent for Closed-Loop
Batch Vapor Degreasing for Rayon Fabric Scouring for Rocket Booster
Nozzle Production for Federal Agencies and Their Contractors
In the 2023 TCE proposed rule, EPA included several longer
timeframes for TCE uses specifically to foster and support Federal
Agencies' missions related to national security and critical
infrastructure. EPA received public comment on one of these conditions
of use and provisions that relate to compliance. The comment relates to
the phase-out 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 proposed 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 NASA) would need to conduct a
final pre-launch test of rocket boosters without using TCE. By 10 years
from the publication date of the final rule, the phase-out would be
complete and industrial and commercial use of TCE as a solvent for
closed-loop batch vapor degreasing would be prohibited. A commenter
brought to EPA's attention that although EPA proposed to require the
testing of an alternative process, the proposed regulation did not
include a requirement to switch to an alternative once a suitable one
was fully validated (Ref. 44). As the commenter noted, such a
requirement is necessary to prompt users to discover and implement
effective and safer alternatives to TCE. EPA agrees, as the intention
of this phase-out and the 5-year testing requirement is to incentivize
TCE users to transition away as fast as practicable. Based on this
public comment, EPA has modified the regulatory text to require use of
the tested alternative if it proves to be an adequate substitute.
4. Definitions
EPA proposed to add definitions for ``Authorized person,''
``ECEL,'' ``Exposure group,'' ``Owner or operator,'' ``Potentially
exposed person,'' ``Regulated area,'' and ``Retailer'' to 40 CFR part
751, subpart A. The final rule under TSCA section 6 to address the
unreasonable risk presented by methylene chloride (89 FR 39254, May 8,
2024 (FRL-8155-01-OCSPP)) added the definitions for ``Authorized
person,'' ``Owner or operator,'' ``Potentially exposed person,''
``Regulated area,'' and ``Retailer'' to subpart A. The final rule under
TSCA section 6 to address the unreasonable risk presented by PCE (RIN
2070-AK84) added the definition for ``Exposure group'' and ``ECEL'' to
subpart A.
In this final rule, EPA is adding a definition for ``interim ECEL''
to subpart D to incorporate the interim ECEL value discussed in Unit
III.A.1. and to make it clear that the interim ECEL is only applicable
during the phaseout and TSCA section 6(g) exemption periods. EPA has
also revised the proposed subpart D definition of ``ECEL action level''
to refer to an ``interim ECEL action level'' and to incorporate the
interim ECEL action level value described in Unit III.A.1.
Lastly, to provide additional clarity, EPA has revised its proposed
descriptions in the preamble of industrial and commercial use of TCE as
solvent for open-top or closed-loop batch vapor degreasing for
essential aerospace parts and for narrow tubing for medical devices.
The revised descriptions appear in Unit IV.B.1.
[[Page 102594]]
IV. Provisions of the Final Rule
EPA intends that each provision of this rulemaking be severable. In
the event of litigation staying, remanding, or invalidating EPA's risk
management approach for one or more conditions of use in this rule, EPA
intends to preserve the risk management approaches in the rule for all
other conditions of use to the fullest extent possible. The Agency
evaluated the risk management options in TSCA section 6(a)(1) through
(7) for each condition of use and generally EPA's regulation of one
condition of use to address its contribution to the unreasonable risk
from TCE functions independently from EPA's regulation of other
conditions of use, which may have different characteristics leading to
EPA's risk management decisions. Further, the Agency crafted this rule
so that different risk management approaches are reflected in different
provisions or elements of the rule that are capable of operating
independently. Accordingly, the Agency has organized the rule so that
if any provision or element of this rule is determined by judicial
review or operation of law to be invalid, that partial invalidation
will not render the remainder of this rule invalid.
There are many permutations of this. For example, as discussed in
Unit IV.B., this final rule prohibits industrial and commercial use of
adhesives and sealants that contain TCE (with subsets of this use with
a delayed compliance date as described in Unit IV.B.2. or an exemption
as described in Unit IV.G.). This final rule also prohibits all
consumer uses of TCE as discussed in Unit IV.B.1. To the extent that a
court were to find that EPA lacked substantial evidence to support its
prohibition of adhesives and sealants or otherwise found legal issues
with EPA's approach to that condition of use, it would have no bearing
on other similarly situated conditions of use, such as those involving
consumer use of TCE, unless the specific issue also applies to the
particular facts associated with consumer use. This is reflected in the
structure of the rule, which describes the specific prohibitions
separately by compliance date. EPA also intends all TSCA section 6(a)
risk management elements in this rule to be severable from each TSCA
section 6(g) exemption. EPA has the authority to promulgate TSCA
section 6(g) exemptions ``as part of a rule promulgated under [TSCA
section 6(a)].'' However, EPA's risk management decisions under TSCA
sections 6(a) and 6(c) are independent from EPA's consideration of
whether it is appropriate, based on the factors in TSCA section 6(g),
to exempt specific conditions of use from the requirements of the TSCA
section 6(a) risk management elements in the rule. In other words, EPA
first decides whether and how to regulate each condition of use, per
TSCA sections 6(a) through (c), and only then determines whether an
exemption under TSCA section 6(g) is appropriate. Accordingly, the
underlying TSCA section 6(a) risk management elements would not be
impacted if a TSCA section 6(g) exemption is determined by judicial
review or operation of law to be invalid. Rather, the exempted
condition of use would become subject to the underlying TSCA section
6(a) risk management element(s).
EPA also notes that there are multiple avenues to ask EPA to
revisit issues in this TSCA section 6(a) rulemaking, both before and
after the mandatory compliance dates are set consistent with TSCA
section 6(d). EPA has the authority under TSCA section 6(g) to consider
whether an exemption is appropriate and, consistent with TSCA section
6(g)(1), may propose such exemptions independently from this
rulemaking. Additionally, any person could petition EPA to request that
EPA issue or amend a rule under TSCA section 6.
A. Applicability
This final rule sets prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
commercial use, and dispo
[…truncated; see source link]Indexed from Federal Register on December 17, 2024.
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