[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Proposed Rules]
[Pages 74712-74794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23010]
[[Page 74711]]
Vol. 88
Tuesday,
No. 209
October 31, 2023
Part III
Environmental Protection Agency
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40 CFR Part 751
Trichloroethylene (TCE); Regulation Under the Toxic Substances Control
Act (TSCA); Proposed Rule
Federal Register / Vol. 88 , No. 209 / Tuesday, October 31, 2023 /
Proposed Rules
[[Page 74712]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0642; FRL-8317-01-OCSPP]
RIN 2070-AK83
Trichloroethylene (TCE); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
address the unreasonable risk of injury to human health presented by
trichloroethylene (TCE) under its conditions of use as documented in
EPA's November 2020 Risk Evaluation for TCE and January 2023 revised
risk determination for TCE pursuant to the Toxic Substances Control Act
(TSCA). TCE is widely used as a solvent in a variety of industrial,
commercial and consumer applications including for hydrofluorocarbon
(HFC) production, vapor and aerosol degreasing, and in lubricants,
greases, adhesives, and sealants. TSCA requires that when EPA
determines a chemical substance presents unreasonable risk that EPA
address by rule the unreasonable risk of injury to health or the
environment and apply requirements to the extent necessary so the
chemical no longer presents unreasonable risk. EPA determined that TCE
presents an unreasonable risk of injury to health due to the
significant adverse health effects associated with exposure to TCE,
including non-cancer effects (liver toxicity, kidney toxicity,
neurotoxicity, immunotoxicity, reproductive toxicity, and developmental
toxicity) as well as cancer (liver, kidney, and non-Hodgkin lymphoma)
from chronic inhalation and dermal exposures to TCE. TCE is a
neurotoxicant and is carcinogenic to humans by all routes of exposure.
The most sensitive adverse effects of TCE exposure are non-cancer
effects (developmental toxicity and immunosuppression) for acute
exposures and developmental toxicity and autoimmunity for chronic
exposures. To address the identified unreasonable risk, EPA is
proposing to: prohibit all manufacture (including import), processing,
and distribution in commerce of TCE and industrial and commercial use
of TCE for all uses, with longer compliance timeframes and workplace
controls for certain processing and industrial and commercial uses
(including proposed phaseouts and time-limited exemptions); prohibit
the disposal of TCE to industrial pre-treatment, industrial treatment,
or publicly owned treatment works, with a time-limited exemption for
cleanup projects; and establish recordkeeping and downstream
notification requirements.
DATES: Comments must be received on or before December 15, 2023. Under
the Paperwork Reduction Act (PRA), comments on the information
collection provisions are best assured of consideration if the Office
of Management and Budget (OMB) receives a copy of your comments on or
before November 30, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0465, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Gabriela Rossner, Existing
Chemicals Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number (202) 565-2426; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of TCE or products containing TCE. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities include:
Crude Petroleum Extraction (NAICS code 211120);
Fossil Fuel Electric Power Generation (NAICS code 221112);
Other Electric Power Generation (NAICS code 221118);
Broadwoven Fabric Mills (NAICS code 313210);
Narrow Fabric Mills and Schiffli Machine Embroidery (NAICS
code 313220);
Nonwoven Fabric Mills (NAICS code 313230);
Textile and Fabric Finishing Mills (NAICS code 313310);
Fabric Coating Mills (NAICS code 313320);
Wood Window and Door Manufacturing (NAICS code 321911);
Prefabricated Wood Building Manufacturing (NAICS code
321992);
Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220);
Petroleum Refineries (NAICS code 324110);
All Other Petroleum and Coal Products Manufacturing (NAICS
code 324199);
Petrochemical Manufacturing (NAICS code 325110);
Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
Ethyl Alcohol Manufacturing (NAICS code 325193);
All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
Plastics Material and Resin Manufacturing (NAICS code
325211);
Medicinal and Botanical Manufacturing (NAICS code 325411);
Pharmaceutical Preparation Manufacturing (NAICS code
325412);
Paint and Coating Manufacturing (NAICS code 325510);
Adhesive Manufacturing (NAICS code 325520);
Polish and Other Sanitation Good Manufacturing (NAICS code
325612);
Photographic Film, Paper, Plate and Chemical Manufacturing
(NAICS code 325992);
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
Polystyrene Foam Product Manufacturing (NAICS code
326140);
Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS code 326150);
Tire Manufacturing (except Retreading) (NAICS code
326211);
Tire Retreading (NAICS code 326212);
Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220);
Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291);
All Other Rubber Product Manufacturing (NAICS code
326299);
[[Page 74713]]
Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110);
Gypsum Product Manufacturing (NAICS code 327420);
Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
code 331110);
Iron and Steel Pipe and Tube Manufacturing from Purchased
Steel (NAICS code 331210);
Rolled Steel Shape Manufacturing (NAICS code 331221);
Steel Wire Drawing (NAICS code 331222);
Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410);
Copper Rolling, Drawing, Extruding, and Alloying (NAICS
code.331420);
Nonferrous Metal (except Copper and Aluminum) Rolling,
Drawing and Extruding (NAICS code 331491);
Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492);
Nonferrous Metal Die-Casting Foundries (NAICS code
331523);
Iron and Steel Forging (NAICS code 332111);
Nonferrous Forging (NAICS code 332112);
Custom Roll Forming (NAICS code 332114);
Powder Metallurgy Part Manufacturing (NAICS code 332117);
Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119);
Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215);
Saw Blade and Handtool Manufacturing (NAICS code 332216);
Metal Window and Door Manufacturing (NAICS code 332321);
Sheet Metal Work Manufacturing (NAICS code 332322);
Ornamental and Architectural Metal Work Manufacturing
(NAICS code 332323);
Power Boiler and Heat Exchanger Manufacturing (NAICS code
332410);
Metal Tank (Heavy Gauge) Manufacturing (NAICS code
332420);
Metal Can Manufacturing (NAICS code 332431);
Other Metal Container Manufacturing (NAICS code 332439);
Hardware Manufacturing (NAICS code 332510);
Spring Manufacturing (NAICS code 332613);
Other Fabricated Wire Product Manufacturing (NAICS code
332618);
Machine Shops (NAICS code 332710);
Precision Turned Product Manufacturing (NAICS code
332721);
Bolt, Nut, Screw, Rivet and Washer Manufacturing (NAICS
code 332722);
Metal Heat Treating (NAICS code 332811);
Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812);
Electroplating, Plating, Polishing, Anodizing and Coloring
(NAICS code 332813);
Industrial Valve Manufacturing (NAICS code 332911);
Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912);
Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913);
Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919);
Ball and Roller Bearing Manufacturing (NAICS code 332991);
Small Arms Ammunition Manufacturing (NAICS code 332992);
Ammunition (except Small Arms) Manufacturing (NAICS code
332993);
Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994);
Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996);
All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999);
Farm Machinery and Equipment Manufacturing (NAICS code
333111);
Lawn and Garden Tractor and Home Lawn and Garden Equipment
Manufacturing (NAICS code 333112);
Construction Machinery Manufacturing (NAICS code 333120);
Mining Machinery and Equipment Manufacturing (NAICS code
333131);
Oil and Gas Field Machinery and Equipment Manufacturing
(NAICS code 333132);
Food Product Machinery Manufacturing (NAICS code 333241);
Semiconductor Machinery Manufacturing (NAICS code 333242);
Sawmill, Woodworking, and Paper Machinery Manufacturing
(NAICS code 333243);
Printing Machinery and Equipment Manufacturing (NAICS code
333244);
Other Industrial Machinery Manufacturing (NAICS code
333249);
Optical Instrument and Lens Manufacturing (NAICS code
333314);
Photographic and Photocopying Equipment Manufacturing
(NAICS code 333316);
Other Commercial and Service Industry Machinery
Manufacturing (NAICS code 333318);
Industrial and Commercial Fan and Blower and Air
Purification Equipment Manufacturing (NAICS code 333413);
Heating Equipment (except Warm Air Furnaces) Manufacturing
(NAICS code 333414);
Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415);
Industrial Mold Manufacturing (NAICS code 333511);
Special Die and Tool, Die Set, Jig and Fixture
Manufacturing (NAICS code 333514);
Cutting Tool and Machine Tool Accessory Manufacturing
(NAICS code 333515);
Machine Tool Manufacturing (NAICS code 333517);
Rolling Mill and Other Metalworking Machinery
Manufacturing (NAICS code 333519);
Turbine and Turbine Generator Set Unit Manufacturing
(NAICS code 333611);
Speed Changer, Industrial High-Speed Drive and Gear
Manufacturing (NAICS code 333612);
Mechanical Power Transmission Equipment Manufacturing
(NAICS code 333613);
Other Engine Equipment Manufacturing (NAICS code 333618);
Air and Gas Compressor Manufacturing (NAICS code 333912);
Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914);
Elevator and Moving Stairway Manufacturing (NAICS code
333921);
Conveyor and Conveying Equipment Manufacturing (NAICS code
333922);
Overhead Traveling Crane, Hoist and Monorail System
Manufacturing (NAICS code 333923);
Industrial Truck, Tractor, Trailer and Stacker Machinery
Manufacturing (NAICS code 333924);
Power-Driven Hand Tool Manufacturing (NAICS code 333991);
Welding and Soldering Equipment Manufacturing (NAICS code
333992);
Packaging Machinery Manufacturing (NAICS code 333993);
Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994);
Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995);
Fluid Power Pump and Motor Manufacturing (NAICS code
333996);
Scale and Balance Manufacturing (NAICS code 333997);
All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999);
Audio and Video Equipment Manufacturing (NAICS code
334310);
Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing (NAICS code 334416);
Electronic Connector Manufacturing (NAICS code 334417);
[[Page 74714]]
Printed Circuit Assembly (Electronic Assembly)
Manufacturing (NAICS code 334418);
Other Electronic Component Manufacturing (NAICS code
334419);
Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS code 334511);
Automatic Environmental Control Manufacturing for
Residential, Commercial and Appliance Use (NAICS code 334512);
Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513);
Instrument Manufacturing for Measuring and Testing
Electricity and Electrical Signals (NAICS code 334515);
Electric Lamp Bulb and Part Manufacturing (NAICS code
335110);
Residential Electric Lighting Fixture Manufacturing (NAICS
code 335121);
Commercial, Industrial and Institutional Electric Lighting
Fixture Manufacturing (NAICS code 335122);
Other Lighting Equipment Manufacturing (NAICS code
335129);
Major Household Appliance Manufacturing (NAICS code
335220);
Power, Distribution and Specialty Transformer
Manufacturing (NAICS code 335311);
Motor and Generator Manufacturing (NAICS code 335312);
Switchgear and Switchboard Apparatus Manufacturing (NAICS
code 335313);
Relay and Industrial Control Manufacturing (NAICS code
335314);
Storage Battery Manufacturing (NAICS code 335911);
Fiber Optic Cable Manufacturing (NAICS code 335921);
Current-Carrying Wiring Device Manufacturing (NAICS code
335931);
Carbon and Graphite Product Manufacturing (NAICS code
335991);
Automobile Manufacturing (NAICS code 336111);
Light Truck and Utility Vehicle Manufacturing (NAICS code
336112);
Heavy Duty Truck Manufacturing (NAICS code 336120);
Motor Vehicle Body Manufacturing (NAICS code 336211);
Truck Trailer Manufacturing (NAICS code 336212);
Motor Home Manufacturing (NAICS code 336213);
Travel Trailer and Camper Manufacturing (NAICS code
336214);
Motor Vehicle Gasoline Engine and Engine Parts
Manufacturing (NAICS code 336310);
Motor Vehicle Electrical and Electronic Equipment
Manufacturing (NAICS code 336320);
Motor Vehicle Steering and Suspension Components (except
Spring) Manufacturing (NAICS code 336330);
Motor Vehicle Brake System Manufacturing (NAICS code
336340);
Motor Vehicle Transmission and Power Train Parts
Manufacturing (NAICS code 336350);
Motor Vehicle Seating and Interior Trim Manufacturing
(NAICS code 336360);
Motor Vehicle Metal Stamping (NAICS code 336370);
Other Motor Vehicle Parts Manufacturing (NAICS code
336390);
Aircraft Manufacturing (NAICS code 336411);
Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412);
Other Aircraft Part and Auxiliary Equipment Manufacturing
(NAICS code 336413);
Guided Missile and Space Vehicle Manufacturing (NAICS code
336414);
Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415);
Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419);
Railroad Rolling Stock Manufacturing (NAICS code 336510);
Ship Building and Repairing (NAICS code 336611);
Boat Building (NAICS code 336612);
Motorcycle, Bicycle and Parts Manufacturing (NAICS code
336991);
Military Armored Vehicle, Tank and Tank Component
Manufacturing (NAICS code 336992);
All Other Transportation Equipment Manufacturing (NAICS
code 336999);
Wood Kitchen Cabinet and Counter Top Manufacturing (NAICS
code 337110);
Upholstered Household Furniture Manufacturing (NAICS code
337121);
Nonupholstered Wood Household Furniture Manufacturing
(NAICS code 337122);
Metal Household Furniture Manufacturing (NAICS code
337124);
Institutional Furniture Manufacturing (NAICS code 337127);
Wood Office Furniture Manufacturing (NAICS code 337211);
Surgical Appliance and Supplies Manufacturing (NAICS code
339113);
Dental Equipment and Supplies Manufacturing (NAICS code
339114);
Jewelry and Silverware Manufacturing (NAICS code 339910);
Sporting and Athletic Goods Manufacturing (NAICS code
339920);
Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991);
Fastener, Button, Needle and Pin Manufacturing (NAICS code
339993);
All Other Miscellaneous Manufacturing (NAICS code 339999);
Metal Service Centers and Other Metal Merchant Wholesalers
(NAICS code 423510);
Industrial Supplies Merchant Wholesalers (NAICS code
423510);
Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690);
Paint, Varnish, and Supplies Merchant Wholesalers (NAICS
code 424950);
New Car Dealers (NAICS code 441110);
Used Car Dealers (NAICS code 441120);
Sporting Goods Stores (NAICS code 451110);
Scheduled Passenger Air Transportation (NAICS code
481111);
Other Support Activities for Air Transportation (NAICS
code 481111);
Other Warehousing and Storage (NAICS code 493190);
Motion Picture and Video Production (NAICS code 512110);
Other Financial Vehicles (NAICS code 525990);
Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715);
Research and Development in the Social Sciences and
Humanities (NAICS code 541720);
Offices of Other Holding Companies (NAICS code 551112);
Carpet and Upholstery Cleaning Services (NAICS code
561740);
Hazardous Waste Treatment and Disposal (NAICS code
562211);
Solid Waste Landfill (NAICS code 562212);
Materials Recovery Facilities (NAICS code 562920);
Junior Colleges (NAICS code 611210);
Colleges, Universities and Professional Schools (NAICS
code 611310);
General Automotive Repair (NAICS code 811111);
Automotive Exhaust System Repair (NAICS code 811112);
Automotive Transmission Repair (NAICS code 811113);
Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118);
Automotive Body, Paint and Interior Repair and Maintenance
(NAICS code 811121);
Automotive Glass Replacement Shops (NAICS code 811122);
Automotive Oil Change and Lubrication Shops (NAICS code
811191);
[[Page 74715]]
All Other Automotive Repair and Maintenance (NAICS code
811198);
Consumer Electronics Repair and Maintenance (NAICS code
811211);
Computer and Office Machine Repair and Maintenance (NAICS
code 811212);
Communication Equipment Repair and Maintenance (NAICS code
811213);
Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219);
Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
Home and Garden Equipment Repair and Maintenance (NAICS
code 811411);
Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490);
Coin-Operated Laundries and Drycleaners (NAICS code
812310);
Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320); and
Industrial Launderers (NAICS code 812332).
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127; see also 19 CFR 127.28. Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that TCE presents an
unreasonable risk of injury to health, without consideration of costs
or other nonrisk factors, including an unreasonable risk to potentially
exposed or susceptible subpopulations (PESS) identified as relevant to
the 2020 Risk Evaluation for TCE by EPA, under the conditions of use
(Refs. 1, 2). The term ``conditions of use'' is defined at TSCA section
3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
A detailed description of the conditions of use that EPA evaluated in
reaching its determination that TCE presents an unreasonable risk is
included in Unit III.B.1. EPA notes that all TSCA conditions of use of
TCE are subject to this proposal. Accordingly, to address the
unreasonable risk, EPA is proposing, under TSCA section 6(a), to:
(i) Prohibit the manufacture (including import), processing, and
distribution in commerce of TCE for all uses (including all consumer
uses (see Unit III.B.1.f)), as described in Unit V.A.1., with longer
compliance timeframes for manufacture and processing related to certain
uses;
(ii) Prohibit the industrial and commercial use of TCE, as
described in Unit V.A.1., with longer compliance timeframes for certain
uses;
(iii) Prohibit the manufacture (including import) and processing of
TCE as an intermediate for the manufacturing of hydrofluorocarbon134a
(HFC-134a), following an 8.5-year phaseout, as described in Unit
V.A.1.d.;
(iv) Prohibit the industrial and commercial use of TCE as a solvent
for closed-loop batch vapor degreasing for rayon fabric scouring for
end use in rocket booster nozzle production by Federal agencies and
their contractors, following a 10-year phaseout, outlined in Unit
V.A.1.e.;
(iv) For Department of Defense (DoD) naval vessels and their
systems, and in the maintenance, fabrication, and sustainment for and
of such vessels and systems, prohibit the industrial and commercial use
of TCE as potting compounds for naval electronic systems and equipment;
sealing compounds for high and ultra-high vacuum systems; bonding
compounds for materials testing and maintenance of underwater systems
and bonding of nonmetallic materials; and cleaning requirements (which
includes degreasing using wipes, sprays, solvents and vapor degreasing)
for: materials and components required for military ordinance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes, following a 10-year TSCA section 6(g) exemption, outlined in
Unit V.A.3.;
(v) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of TCE as a processing aid for
battery separator manufacturing, following a 10-year TSCA section 6(g)
exemption, as described in Unit V.A.3.;
(vi) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of TCE as a laboratory chemical for
essential laboratory activities and some research and development
activities, following a 50-year TSCA section 6(g) exemption, as
described in Unit V. A.3.;
(vii) Prohibit the manufacture (including import), processing,
distribution in commerce, and industrial and commercial use of TCE as a
solvent in closed loop vapor degreasing necessary for human-rated
rocket engine cleaning by the National Aeronautics and Space
Administration (NASA) and its contractors, following a 7-year TSCA
section 6(g) exemption, as described in Unit V.A.3.;
(viii) Prohibit the emergency industrial and commercial use of TCE
in furtherance of the NASA mission for specific conditions that are
critical or essential and for which no technically and economically
feasible safer alternative is available, following a 10-year TSCA
section 6(g) exemption, as described in Unit V.A.3.;
(ix) Require strict workplace controls, including compliance with a
TCE workplace chemical protection program (WCPP), which would include
requirements for an inhalation exposure limit and dermal protection to
limit exposure to TCE, for conditions of use with long term phaseouts
or time-
[[Page 74716]]
limited exemptions under TSCA section 6(g), as described in Unit
V.A.2.;
(x) Prohibit, due to worker risks, the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works, with a 50-year TSCA section 6(g) exemption for cleanup
projects, as described in Unit V.A.3.; and
(xi) Establish recordkeeping and downstream notification
requirements, as described in Unit V.A.4.
In addition, EPA is proposing to amend the general provisions of 40
CFR part 751, subpart A, to define the following terms so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751: ``authorized
person,'' ``ECEL,'' ``exposure group,'' ``owner or operator,''
``potentially exposed person,'' ``regulated area,'' and ``retailer.''
EPA seeks public comment on all aspects of this proposed rule.
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' TCE was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in November 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in January 2023 (Ref.
2), determining that TCE, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. As a
result, EPA is proposing to take action to the extent necessary so that
TCE no longer presents such risk. The unreasonable risk is described in
Unit III.B.2. and the conditions of use EPA evaluated in reaching its
conclusion that TCE presents unreasonable risk are described in Unit
III.B.1.
TCE's hazards are well established. EPA's 2020 Risk Evaluation for
TCE considered the hazards associated with exposure to TCE and
determined that TCE presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to TCE. While some of the risks of adverse effects from TCE exposure
are experienced following acute single exposures, other risks are
incurred following long-term repeated exposures. Risk of non-cancer
effects, specifically fetal cardiac defects and autoimmunity following
chronic exposure, are the most sensitive adverse effects. In addition,
risks of other significant adverse outcomes associated with TCE
exposure include: Non-cancer effects (liver toxicity, kidney toxicity,
neurotoxicity, immunosuppression, reproductive toxicity, and
developmental toxicity), as well as cancer effects (liver, kidney, and
non-Hodgkin lymphoma). EPA is proposing requirements so that TCE would
no longer present unreasonable risk to human health.
While EPA's proposal would ultimately result in a complete ban on
TCE, the Agency recognizes that a phaseout of TCE for some TSCA
conditions of use may be appropriate. The timeframes for the phaseouts
differ across conditions of use and are described in fuller detail in
Unit V.A.1.d. and e. One phaseout is for uses that may impact the
Agency's efforts to address climate-damaging HFCs (and the associated
adverse impacts on human health and the environment) under the American
Innovation and Manufacturing Act of 2020 (AIM Act) (42 U.S.C. 7675).
EPA proposes to implement a longer phaseout in tandem with strict
workplace controls for the manufacturing (including import) and
processing of TCE as an intermediate in the generation of HFC-134a, one
of the regulated substances subject to a phasedown under the AIM Act
(More information on HFC-134a is in Unit V.A.1.). While HFC-134a is one
of the regulated substances subject to AIM Act 85% phasedown in
generation and consumption by 2023, HFC-134a can be mixed with other
substances to make lower global warming potential (GWP) blends that are
likely to be used to facilitate the transition from certain other HFCs
and HFC blends with higher global warming potentials in certain
applications.
Additionally, the Agency recognizes that some conditions of use may
not have alternatives readily available. As an example, EPA is
proposing a longer phaseout timeframe for industrial and commercial use
as a solvent for closed-loop batch vapor degreasing for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, in addition to the uses of TCE
necessary for DoD vessels. Currently, substitutes and alternative
processes do not meet the technical specifications required to clean
the rayon fabric in order to safely produce rockets.
Additionally, EPA recognizes that some conditions of use may be
important for national security applications or for other critical
needs. For these reasons, EPA's proposal includes a 10-year exemption
under TSCA section 6(g) for industrial and commercial use of TCE as a
processing aid for battery separator manufacturing in the production of
lead-acid and lithium battery separators, as well as for the
manufacturing, processing, and distribution in commerce of TCE for this
use (See Unit V.A.3.a.i.). EPA recognizes that lead-acid and lithium
battery separators are essential components of batteries that power
vehicles and systems in the U.S. supply chain for multiple critical
infrastructure sectors within the national economy. Further, there are
a number of critical uses required for DoD vessels. EPA is proposing a
10-year exemption under TSCA section 6(g) for DoD vessel requirements
for potting, bonding and sealing compounds, and bonding and cleaning
requirements for naval combat systems, radars, sensors, equipment, and
fabrication and prototyping processes. Additionally, EPA is proposing a
50-year exemption under TSCA section 6(g) for the industrial and
commercial use of TCE in laboratory use for essential laboratory
activities which are particularly critical; for example, laboratory
activities associated with ongoing environmental cleanup projects that
fall under the Superfund program or other similar EPA authorities, in
which it is necessary to use TCE as a laboratory chemical for the
analysis of contaminated soil, air, and water samples (See Unit
V.A.3.a.iii.).
EPA considered the potential impact of the prohibition of the total
production volume of TCE regulated under TSCA on the availability of
TCE for critical or essential uses, for uses essential to the national
economy, national security, or critical infrastructure, and for uses
for which longer phase-out timeframes are proposed. EPA concluded,
based on information received through stakeholder engagement and
professional judgment, that there would remain a sufficient supply of
TCE in circulation for these uses. EPA requests comment on whether
there would remain a sufficient supply of TCE in circulation to provide
a source for those limited critical or essential uses exempted under
TSCA section 6(g), as described in Unit V. (Ref. 3).
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis of the potential incremental
[[Page 74717]]
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 3). As described in more detail in the Economic
Analysis (Ref. 3) and in Units VII.D. and XI.D., EPA was unable to
quantify all incremental costs of this proposed rule. The quantifiable
cost of the proposed rule is estimated to be $33.1 million annualized
over 20 years at a 3% discount rate and $40.6 million annualized over
20 years at a 7% discount rate. These costs take compliance with
implementation of a WCPP into consideration, which would include an
existing chemical exposure limit (ECEL) of 0.0011 ppm (1.1 ppb; 0.0059
mg/m\3\) for inhalation exposures as an 8-hour time-weighted average
(TWA), applicable personal protective equipment (PPE) requirements, and
reformulation costs of numerous products. There are a number of notable
unquantified costs. These are described in this Unit and more fully in
section 7.11 of the Economic Analysis (Ref. 3).
Alternative products with similar cost and efficacy are available
for most of the products that are formulated with TCE. However, for
some applications, there may be additional unquantified costs
associated with the alternatives or in cases where alternatives are not
currently available. For instance, in some cases, some effort might be
required by firms using TCE products to identify suitable alternatives,
test them for their desired applications, learn how to use them safely
and effectively, and implement new processes for using the alternative
products. There may also be some safety-critical applications where
alternatives would need to undergo extensive safety reviews and testing
before they could replace the TCE products. The information to estimate
how often these costs might be incurred or what the specific costs
would be per-user or per-firm when they are incurred is not available.
Therefore, EPA is unable to consider these costs quantitatively.
There also may be some unquantified costs associated with the
implementation of a WCPP. EPA estimated a distribution for air
monitoring results but since these data were not collected in the same
way monitoring data under a WCPP would be collected, these estimated
distributions are uncertain and therefore, the costs of the WCPP are
uncertain. The WCPP costs also assume that when the exposure levels
exceed the ECEL, compliance is achieved by implementing a respirator
PPE program. However, the options require that feasible engineering and
administrative controls are implemented before resorting to PPE use.
These costs would be specific to individual firms, and EPA does not
have sufficient information to estimate these costs.
The costs of alternative identification, testing, and potential
process changes to battery separator manufacturers could not be
estimated. And, if battery separator manufacturers are unable to
transition to TCE-free production processes within the 10-year
timeframe, there could be battery separator supply chain disruptions.
According to one battery separator manufacturer submitting an exemption
request to EPA, 80% of lead-acid and lithium-ion batteries are built
using battery separators manufactured with TCE. According to the
Battery Council International, the U.S. lead-acid battery industry
provides $13.7 billion in gross domestic product. Both battery
separator manufacturers submitting exemption requests noted that there
was only one domestic battery separator manufacturer that does not use
TCE for each of lead-acid and lithium batteries, and they asserted that
the manufacturers would not have sufficient capacity to meet domestic
battery separator demand on their own and could likely support less
than half of the U.S. battery production need. In addition, they also
noted that the domestic battery separator manufacturer that does not
use TCE for lithium batteries uses a ``dry process'' instead of a ``wet
process'', and the ``dry process'' does not allow for reliable
manufacture of the 9-12 [mu]m separators that are generally used for
electric vehicle applications. However, the magnitude of economic
impacts from a potential supply chain disruption is uncertain,
particularly since EPA could take subsequent regulatory action to
extend, modify, or eliminate the exemption on the basis of reasonably
available information and adequate public justification.
EPA expects the processing of TCE as an intermediate for the
manufacture of HFC-134a to decline over time, in light of the AIM Act
requirements (Ref. 4). At some point, the domestic manufacture of HFC-
134a may be discontinued. While the timing for this discontinuation is
uncertain, it is unclear whether the proposed rule would hasten the
closure of plants that use TCE to produce HFC-134a. There would be some
unknown cost impacts associated with hastening the closure of these two
plants.
Costs to both fluoroelastomer producers using TCE and those using
TCE as an intermediate to manufacture hydrochloric acid (HCl) may
include potential supply chain disruptions, which could not be
estimated. It is expected that these facilities would need to adopt
process and/or physical plant changes in order to comply with the
proposed rule. EPA does not have sufficient information to estimate the
costs of the prohibition to these sectors.
Additionally, EPA is proposing a 10-year phaseout for the
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production by Federal agencies and their contractors,
conditioned on Federal agencies performing within 5 years a final pre-
launch test of rocket booster nozzles that have been produced without
using TCE. EPA does not have information to estimate the cost of such a
test. The disposal of TCE from cleanup projects to industrial pre-
treatment, industrial treatment, or publicly owned treatment work would
be prohibited after the section 6(g) exemption ends, 50 years after the
rule is finalized. Cleanup sites would need to identify and implement
alternative disposal or treatment methods, and would likely also need
to renegotiate RCRA permits or CERCLA agreements to include those
changes. These approaches could be more costly to implement and/or
increase the duration of cleanups allowing any potential environmental
or human health impacts to continue for a longer period of time. The
information to estimate how often these costs might be incurred or what
the specific costs would be per site when they are incurred is not
available. Furthermore, the number of sites affected by this
prohibition is unknown.
Finally, EPA could not estimate any potential business closures or
off-shoring of businesses that might result from the proposed rule.
Vapor degreasing is one use of TCE where switching to a suitable
alternative may be challenging and where closing or off-shoring may be
a compliance strategy. EPA estimates that 366 facilities still use TCE
in vapor degreasers, a majority of which are small businesses. There is
no standard generally accepted approach for estimating the cost impacts
of a firm closure. Despite information EPA has sought from
stakeholders, including through a Small Business Advocacy Review (SBAR)
Panel, it is still unclear as to the entire impact of a prohibition of
TCE vapor degreasing.
The actions proposed in this rulemaking are expected to achieve
health benefits for the American public, some of which can be monetized
and others that, while tangible and significant, cannot at present be
monetized. The monetized benefits of this rulemaking are approximately
$18.1 to $21.5 million annualized over 20
[[Page 74718]]
years at a 3% discount rate and $8.2 to $10.3 million annualized over
20 years at a 7% discount rate. The monetized benefits only include
liver, kidney, and non-Hodgkin's lymphoma cancers.
There are a number of non-cancer endpoints associated with exposure
to TCE, including liver toxicity, kidney toxicity, reproductive
effects, neurotoxicity, immunotoxicity effects and fetal cardiac
defects (Ref. 1). There is human evidence for hepatitis accompanying
immune-related generalized skin diseases, jaundice, hepatomegaly,
hepatosplenomegaly, and liver failure in TCE-exposed workers and
changes in the proximal tubules of the kidney following exposure to
TCE, and occupational studies have shown increased levels of kidney
damage (proximal tubules) and end-stage renal disease in TCE-exposed
workers. Evidence exists to associate TCE with reproductive effects.
Most human studies support an association between TCE exposure and
alterations in sperm density and quality, as well as changes in sexual
drive or function and serum endocrine levels. Fewer epidemiological
studies exist linking decreased incidence of fecundability (time-to-
pregnancy) and menstrual cycle disturbances in women with TCE
exposures. Human studies have consistently reported vestibular system-
related symptoms such as headaches, dizziness, and nausea following TCE
exposure. Several newer epidemiological studies have found an
association between TCE exposure and neurodegenerative disorders such
as amyotrophic lateral sclerosis and Parkinson's disease (Ref. 1). EPA
does not have sufficient information to estimate the monetized benefits
of the proposed rule with respect to these non-cancer effects, and
therefore monetized benefits are likely underestimated.
EPA does estimate that there are 52,595 workers and occupational
non-users (ONUs, or people who do not directly handle the chemical, but
are in close proximity) exposed to TCE and of those, approximately 982
pregnant workers and ONUs annually that may potentially benefit from a
reduced risk of fetal cardiac defects resulting from reduced TCE
exposure. Although EPA has not developed a complete estimate of the
monetized benefits associated with avoiding fetal cardiac defects, as
described in the Economic Analysis (Ref. 3), Arth, Tinker et al. (Ref.
5) estimated a mean annual cost of $41,166 (2013$) (median $14,552) for
each fetal cardiac defects-associated hospitalization. For critical
fetal cardiac defects, mean and median costs were estimated at $79,011
and $29,886 (2013$), respectively for each incidence. In addition to
hospitalization costs, individuals with fetal cardiac defects will
likely incur healthcare costs associated with physician visits and
outpatient care. They are also more likely to require specialized
healthcare such as medications, physical or speech therapy, or
treatment for developmental or behavioral problems (Ref. 6). Additional
social costs may include caregiver burden and mental health services
(Ref. 7), as well as non-market costs such as pain and suffering and
fetal cardiac defect-related mortality. Because these costs are not
accounted for, monetized benefits are likely underestimated. The
severity of specific types of fetal cardiac defects and associated
costs will vary depending on the type of heart defect. EPA requests
comment on information that would allow EPA to quantify the magnitude
of avoided risk of fetal cardiac defects due to reductions in TCE
exposure under the proposed rulemaking.
Additionally, to the extent that the proposed rule reduces the
amount of TCE in drinking water systems and thereby exposures to
populations using those drinking water sources, there could be
potential health-related benefits related to improved drinking water
quality that EPA was unable to quantify.
II. Background
A. Overview of TCE
This proposed rule applies to TCE (CASRN 79-01-6) and is intended
to address the unreasonable risk of injury to health that EPA has
identified for TCE. TCE is a volatile organic compound (VOC) used in
industry as well as in commercial and consumer products. The total
aggregate annual production volume ranged from 100 to 250 million
pounds between 2016 and 2019 according to CDR (Ref. 8). The majority of
TCE is processed as an intermediate during the manufacture of
refrigerants, specifically HFC-134a, which accounts for about 83.6% of
TCE's annual production volume (Ref. 1). TCE is also used as a solvent,
frequently in cleaning and degreasing (including spot cleaning, vapor
degreasing, cold cleaning, and aerosol degreasing), which accounts for
another 14.7% of TCE production volume, leaving approximately 1.7% for
other uses. As outlined in Unit III.B.1., TCE is used as a solvent in a
variety of commercial and consumer applications including lubricants,
adhesives and sealants, paints and coatings, and other miscellaneous
products.
B. Regulatory Actions Pertaining to TCE
TCE is subject to numerous Federal laws and regulations in the
United States and is also subject to regulation by some States and
other countries. A summary of EPA regulations pertaining to TCE, as
well as other Federal, State, and international regulations (Ref. 9) is
in the docket and in Appendix A of the 2020 Risk Evaluation for TCE
(Ref. 1).
C. Consideration of Occupational Safety and Health Administration
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA
Risk Management Actions
Although EPA must consider and factor in, to the extent
practicable, certain non-risk factors as part of TSCA section 6(a)
rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still
ensure that the selected regulatory requirements apply ``to the extent
necessary so that the chemical substance or mixture no longer presents
[unreasonable] risk.'' This requirement to eliminate unreasonable risk
is distinguishable from approaches mandated by some other laws,
including the Occupational Safety and Health Act (OSH Act), which
includes both significant risk and feasibility (technical and economic)
considerations in the setting of standards.
Congress intended for EPA to consider occupational risks from
chemicals it evaluates under TSCA, among other potential exposures, as
relevant and appropriate. As noted previously, TSCA section 6(b)
requires EPA to evaluate risks to PESS identified as relevant by the
Administrator. TSCA section 3(12) defines the term ``potentially
exposed or susceptible subpopulation'' as ``a group of individuals
within the general population identified by the Administrator who, due
to either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.''
The OSH Act similarly requires OSHA to evaluate risk specific to
workers prior to promulgating new or revised standards and requires
OSHA standards to substantially reduce significant risk to the extent
feasible, even if workers are exposed over a full working lifetime. See
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
Thus, the standards for chemical hazards that OSHA promulgates
under the OSH Act share a broadly similar
[[Page 74719]]
purpose with the standards that EPA promulgates under TSCA section
6(a). The control measures OSHA and EPA require to satisfy the
objectives of their respective statutes may also, in many
circumstances, overlap or coincide. However, as this unit outlines,
there are important differences between EPA's and OSHA's regulatory
approaches and jurisdiction, and EPA considers these differences when
deciding whether and how to account for OSHA requirements (Ref. 9) when
evaluating and addressing potential unreasonable risk to workers so
that compliance requirements are clearly explained to the regulated
community.
1. OSHA Requirements
OSHA's mission is to ensure that employees work in safe and
healthful conditions. The OSH Act establishes requirements that each
employer comply with the General Duty Clause of the Act (29 U.S.C.
654(a)), as well as with occupational safety and health standards
issued under the Act.
a. General Duty Clause of the OSH Act
The General Duty Clause of the OSH Act requires employers to keep
their workplaces free from recognized hazards that are causing or are
likely to cause death or serious physical harm to employees. The
General Duty Clause is cast in general terms, and does not establish
specific requirements like exposure limits, PPE, or other specific
protective measures that EPA could potentially consider when developing
its risk evaluations or risk management requirements. OSHA, under
limited circumstances, has cited the General Duty Clause for regulating
exposure to chemicals. To prove a violation of the General Duty Clause,
OSHA must prove employer or industry recognition of the hazard, the
hazard was causing or likely to cause death or serious physical harm,
and a feasible method to eliminate or materially reduce the hazard was
available. In rare situations, OSHA has cited employers for violation
of the General Duty Clause where exposures were below a chemical-
specific permissible exposure limit (PEL), a TWA based on an employee's
average airborne exposure in any 8-hour work shift of a 40-hour work
week which shall not be exceeded (Ref. 10). In such situations, OSHA
must demonstrate that the employer had actual knowledge that the PEL
was inadequate to protect its employees from death or serious physical
harm. Because of the heavy evidentiary burden on OSHA to establish
violations of the General Duty Clause, it is not frequently used to
cite employers for employee exposure to chemical hazards.
b. OSHA Standards
OSHA standards are issued pursuant to the OSH Act and are found in
title 29 of the CFR. There are separate standards for general industry,
laboratories, construction, maritime and agriculture sectors, and
general standards applicable to a number of sectors (e.g., OSHA's
Respiratory Protection standard). OSHA has numerous standards that
apply to employers who operate chemical manufacturing and processing
facilities, as well as to downstream employers whose employees may be
occupationally exposed to hazardous chemicals.
OSHA sets legally enforceable limits on the airborne concentrations
of hazardous chemicals, referred to as PELs, established for employers
to protect their workers against the health effects of exposure to
hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart
Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act,
OSHA was permitted an initial 2-year window after the passage of the
Act to adopt ``any national consensus standard and any established
Federal standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971
to establish PELs that were adopted from Federal health standards
originally set by the Department of Labor through the Walsh-Healy Act,
in which approximately 400 occupational exposure limits (OELs) were
selected based on the American Conference of Governmental Industrial
Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In
addition, about 25 exposure limits recommended by the American
Standards Association (now called the American National Standards
Institute or ANSI) were adopted as PELs.
Following the 2-year window provided under section 6(a) of the OSH
Act for adoption of national consensus and existing Federal standards,
OSHA has issued health standards following the requirements in section
6(b) of the Act. OSHA has established approximately 30 PELs under
section 6(b)(5) as part of comprehensive substance-specific standards
that include additional requirements for protective measures such as
use of PPE, establishment of regulated areas, exposure assessment,
hygiene facilities, medical surveillance, and training. These ancillary
provisions in substance-specific OSHA standards further mitigate
residual risk that could be present due to exposure at the PEL.
Many OSHA PELs have not been updated since they were established in
1971, including the PEL for TCE. In many instances, scientific evidence
has accumulated suggesting that the current limits of many PELs are not
sufficiently protective. On October 10, 2014, OSHA published a Federal
Register document in which it recognized that many of its PELs are
outdated and inadequate for ensuring protection of worker health (79 FR
61384). In addition, health standards issued under section 6(b)(5) of
the OSH Act must reduce significant risk only to the extent that it is
technologically and economically feasible. OSHA's legal requirement to
demonstrate that its section 6(b)(5) standards are technologically and
economically feasible at the time they are promulgated often precludes
OSHA from imposing exposure control requirements sufficient to ensure
that the chemical substance no longer presents a significant risk to
workers. As described in that document, while new advancements or
developments in science and technology from the time a PEL is
promulgated may improve the scientific basis for making findings of
significant risk, technical feasibility or economic feasibility, OSHA
has been unable to update most of the PELs established in 1971 and they
remain at levels at which they were initially adopted (79 FR 61384,
October 10, 2014). One example of how industries have evolved in the
intervening 50 years as to what is technologically and economically
feasible is the halogenated solvent cleaning industry, which, in
response to EPA's National Emission Standards for Hazardous Air
Pollutants (NESHAP) promulgated under section 112 of the 1990 Clean Air
Act Amendments (see National Emissions Standards for Halogenated
Solvent Cleaning, 40 CFR part 63, subpart T), has made equipment
improvements that conserve solvent resources and reduce workplace
exposure.
In sum, the great majority of OSHA's chemical standards are
outdated or do not sufficiently reduce risk to workers. While it is
possible in some cases that the OSHA standards for some chemicals
reviewed under TSCA will eliminate unreasonable risk, based on EPA's
experience thus far in conducting occupational risk assessments under
TSCA, EPA believes that OSHA chemical standards would in general be
unlikely to address unreasonable risk to workers within the meaning of
TSCA, since TSCA section 6(b) unreasonable risk determinations may
account for unreasonable risk to more sensitive endpoints (derived from
scientific
[[Page 74720]]
studies that had not yet been conducted at the time OSHA promulgated
its standards) and working populations than OSHA's risk evaluations
typically contemplate, and EPA is obligated to apply TSCA section 6(a)
risk management requirements to the extent necessary so that the
unreasonable risk is no longer presented.
Because the requirements and application of TSCA and OSHA
regulatory analyses differ, and because OSHA's chemical-specific
standards are decades old and may include outdated assumptions
regarding the most sensitive end-point and/or the technological and
economic feasibility of the standards, it is necessary for EPA to
conduct risk evaluations and, where it finds unreasonable risk to
workers, develop risk management requirements for chemical substances
that OSHA also regulates, and it is expected that EPA's findings and
requirements may sometimes diverge from OSHA's. However, it is also
appropriate that EPA consider the chemical standards that OSHA has
already developed to limit the compliance burden to employers by
aligning management approaches required by the agencies, where
alignment will adequately address unreasonable risk to workers. Unit
II.C.2. discusses EPA's consideration of OSHA standards in its risk
evaluation and management strategies under TSCA.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
When characterizing the risk during risk evaluation under TSCA, EPA
believes it is appropriate to evaluate the levels of risk present in
scenarios where no mitigation measures are assumed to be in place for
the purpose of determining unreasonable risk (see Unit II.C.2.a.).
However, the Agency acknowledges that, in some cases, mitigation
measures are already in place. It should be noted that there are some
cases where scenarios may reflect certain mitigation measures, such as
(e.g., in instances where exposure estimates are based on monitoring
data at facilities that have existing engineering controls in place).
For example, the Halogenated Solvent Cleaning NESHAP, first promulgated
in 1994 and last updated in 2007, established standards reflecting the
maximum achievable control technology for major and certain area
sources, standards reflecting generally available control technology
for other area sources, and facility-wide emission limits for certain
halogenated solvent cleaning machines. Consequently, emissions
monitoring from facilities meeting the NESHAP would reflect emissions
reduction resulting from existing engineering controls already in place
to meet the standards.
In addition, EPA believes it may be appropriate to also evaluate
the levels of risk present in scenarios considering applicable OSHA
requirements as well as scenarios considering industry or sector best
practices for industrial hygiene that are clearly articulated to the
Agency. EPA may evaluate risk under scenarios that consider industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency, when doing so serves to inform its risk
management efforts. Characterizing risks using scenarios that reflect
different levels of mitigation can help inform potential risk
management actions by providing information that could be used during
risk management to tailor risk mitigation appropriately to address any
unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).
a. Risk Characterization for Unreasonable Risk Determination
When making unreasonable risk determinations as part of TSCA risk
evaluations, EPA cannot assume as a general matter that all workers are
always equipped with and appropriately using sufficient PPE, although
EPA does not question the veracity of public comments received on the
2020 Risk Evaluation for TCE regarding the occupational safety
practices often followed by industry respondents. When characterizing
the risk to human health from occupational exposures during risk
evaluation under TSCA, EPA believes it is appropriate to evaluate the
levels of risk present in scenarios where PPE is not assumed to be used
by workers. This approach of not assuming PPE use by workers considers
the risk to PESS (workers and occupational non-users (ONUs)) who may
not be covered by OSHA standards, such as self-employed individuals and
public sector workers who are not covered by a State Plan. Mitigation
scenarios included in the EPA risk evaluation (e.g., scenarios
considering use of PPE) likely represent current practice in many
facilities where companies effectively address worker and bystander
safety requirements. However, the Agency cannot assume that all
facilities across all uses of the chemical substance will have adopted
these practices for the purposes of making the TSCA risk determination.
Therefore, EPA makes its determinations of unreasonable risk based
on scenarios that do not assume compliance with OSHA standards,
including any applicable exposure limits or requirements for use of
respiratory protection or other PPE. Making unreasonable risk
determinations based on such scenarios should not be viewed as an
indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread
noncompliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that unreasonable risk may exist for subpopulations of
workers that may be highly exposed because they are not covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by an OSHA State Plan, or because their employer is
out of compliance with OSHA standards, or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding existing OSHA
requirements.
b. Risk Evaluation To Inform Risk Management Requirements
In addition to the scenarios described previously, EPA risk
evaluations may characterize the levels of risk present in scenarios
considering applicable OSHA requirements (e.g., chemical-specific PELs
and/or chemical-specific health standards with PELs and additional
ancillary provisions) as well as scenarios considering industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency to help inform risk management decisions.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
When undertaking risk management actions, EPA: (1) Develops
occupational risk mitigation measures to address any unreasonable risk
identified by EPA, striving for compatibility with applicable OSHA
requirements and industry best practices, including appropriate
application of the hierarchy of controls, when those measures would
address an unreasonable risk; and (2) Ensures that EPA requirements
apply to all potentially exposed workers in accordance with TSCA
requirements. Consistent with TSCA section 9(d), EPA consults and
coordinates TSCA activities with OSHA and other relevant Federal
agencies for the purpose of achieving the maximum applicability of TSCA
while avoiding the imposition of duplicative requirements.
Informed by the mitigation scenarios and information gathered
during the risk evaluation and risk management process, the Agency
might propose rules that require risk management practices that may be
already common practice in many or most facilities. Adopting clear,
broadly applicable regulatory standards will foster compliance across
all
[[Page 74721]]
facilities (ensuring a level playing field) and assure protections for
all affected workers, especially in cases where current OSHA standards
may not apply to them or not be sufficient to address the unreasonable
risk.
For evaluation scenarios which involve OSHA chemical-specific PELs,
EPA's risk evaluation in some cases may illustrate that limiting
exposure to OSHA's PEL would result in acceptable levels of risk under
TSCA under certain conditions of use. In these cases, TSCA risk
management requirements could incorporate and reinforce requirements in
OSHA standards and ensure that risks are addressed, including for
circumstances where OSHA requirements are not applicable (e.g., public
sector workers not covered by an OSHA State plan, and self-employed
workers) by asserting TSCA compliance/enforcement as well. EPA's risk
evaluation may also find unreasonable risk under TSCA associated with
some occupational conditions of use (see Unit III.B.1.f.), even when
the applicable OSHA requirements are being met. In these cases, EPA
would need to develop risk management requirements beyond those
included in OSHA's standards.
4. TCE and OSHA Requirements
EPA incorporated the considerations described in Unit II.C. into
the 2020 Risk Evaluation for TCE, the January 2023 revised unreasonable
risk determination for TCE, and this rulemaking. Specifically, in the
TSCA 2020 Risk Evaluation for TCE, EPA presented risk estimates based
on workers' exposures with and without respiratory protection. EPA
determined that even when respirators are used by workers, most of the
conditions of use evaluated drove the unreasonable risk. Additional
consideration of OSHA standards in the revised unreasonable risk
determination is discussed further in the Federal Register document
announcing that document (Ref. 11). In Unit III.B.3. and Unit
V.A.2.b.iii., EPA outlines the importance of considering the hierarchy
of controls used by the industrial hygiene community (hereafter
referred to as ``hierarchy of controls'') when developing risk
management actions in general, and specifically when determining if and
how regulated entities may meet a risk-based exposure limit for TCE.
The hierarchy of controls is a prioritization of exposure control
strategies from most preferred to least preferred techniques. The
control strategies include elimination of the hazard, substitution with
a less hazardous substance, engineering controls, administrative
controls such as training or exclusion zones with warning signs, and,
finally, use of PPE (Ref. 12). Under the hierarchy of controls, the use
of respirators and dermal PPE should only be considered after all other
steps have been taken to reduce exposures. As discussed in Units V.A.
and VI.A.1., EPA's risk management approach would not rely solely or
primarily on the use of respirators and dermal PPE to address
unreasonable risk to workers; instead, EPA is proposing prohibitions
for all conditions of use, with a WCPP for certain occupational
conditions of use before the prohibitions are fully implemented. The
WCPP would require consideration of the hierarchy of controls before
use of respirators and other PPE. The WCPP is discussed in full in
Units V.A.2. and VI.A.1.b.
In accordance with the approach described in Unit II.C.3., EPA
intends for this regulation to be as compatible as possible with the
existing OSHA standards, with additional requirements as necessary to
address the unreasonable risk. One notable difference between the WCPP
and the OSHA standards are the exposure limits. The WCPP would include
an ECEL of either 0.0011 ppm (1.1 ppb) or 0.0040 ppm (4.0 ppb) as an 8-
hour TWA; exposures at or below each ECEL would not result in
unreasonable risk for chronic cancer and non-cancer and acute non-
cancer inhalation endpoints (See Unit IV.A. for further discussion
about an ECEL of 0.0011 ppm and Unit IV.B. for further discussion about
an ECEL of 0.0040 ppm. Refer to Unit VI.A. for discussion about why EPA
is considering two TCE ECELs and EPA's related request for public
comment). EPA recognizes that for TCE, either ECEL would be
significantly lower than the OSHA PEL (100 ppm as an 8-hour TWA). In
addition to the distinctions in statutory requirements described in
this unit, EPA has identified several factors contributing to the
differences in these levels, outlined here.
The TSCA ECEL value for TCE is a lower value than the OSHA PEL (and
other existing OELs, discussed in Unit II.C.5.) for many reasons,
including that the PEL, established in 1971, may not fully capture
either the complete database of studies considered in the 2020 Risk
Evaluation for TCE or more recent advances in modeling and scientific
interpretation of toxicological data applied in the calculation of the
TCE ECEL. The proposed numeric ECEL values considered for incorporation
into the WCPP are derived from the analysis in the 2020 Risk Evaluation
for TCE, which EPA considers to represent the best available science
under TSCA section 26(h) because it was subject to peer review and is
the result of a systematic review process that considered reasonably
available information in order to identify relevant adverse health
effects. Additionally, by using the information from the 2020 Risk
Evaluation for TCE, the ECEL incorporates advanced modeling and peer-
reviewed methodologies, and accounts for exposures to potentially
exposed and susceptible subpopulations, as required by TSCA.
For TCE, the EPA ECEL is an 8-hour occupational inhalation exposure
limit, and it takes into consideration the uncertainties identified in
the 2020 Risk Evaluation for TCE. For TCE, EPA derived two distinct
ECEL values.
The ECEL of 0.0011 ppm is based on the most sensitive overall human
health endpoint of developmental toxicity, specifically, fetal cardiac
defects based on rat data from Johnson et al., 2003 (Refs. 1, 13). It
represents the concentration at which an individual, including a member
of a PESS, especially older pregnant workers and ONUs (the group
identified as most susceptible to cardiac defects in their developing
fetus based on epidemiological data), would be unlikely to suffer
adverse effects if exposed for a single 8-hr workday. This value is
also protective of health effects that could present following chronic
or lifetime exposures under typical occupational exposure scenarios.
The ECEL of 0.0011 ppm incorporates a benchmark margin of exposure of
10 to account for inter- and intra-species toxicodynamic variability.
In addition to the ECEL, as part of this rulemaking, EPA is proposing
an ECEL action level, which is a value equal to half of the ECEL, that
would trigger additional monitoring to ensure that workers are not
exposed to concentrations above the ECEL. Exposure monitoring and
establishing a baseline of TCE exposure for potentially exposed
persons, as well as identifying the lowest achievable exposure level in
a facility, is further discussed in Unit V.A.2.
The ECEL of 0.0040 ppm is based on chronic autoimmunity,
representing the most protective exposure limit from the best overall
acute and chronic non-cancer endpoints under TSCA of immunosuppression
and autoimmunity, respectively (Refs. 14, 46, 1). The ECEL of 0.0040
ppm is based on elevated anti-double stranded DNA (anti-dsDNA) and
single-stranded DNA (ssDNA) antibodies following chronic exposure based
on mouse data from Keil et al, 2009 (Ref. 1). The ECEL based on
autoimmunity was derived from the PBPK model-adjusted assumptions of 8-
[[Page 74722]]
hour daily exposure and elevated respiratory rate for workers, and it
incorporates a benchmark MOE of 30 to account for inter- and intra-
species toxicodynamic variability as well as the absence of a no-effect
level in the study (Ref. 1).
The OSHA PEL for TCE of 100 ppm as an 8-hour TWA was established in
1971. OSHA is required to promulgate a standard that reduces
significant risk to the extent that it is technologically and
economically feasible to do so (81 FR 16285) at the time of
promulgation. As part of a 1989 air contaminants standard for 428 toxic
substances, OSHA lowered the PEL to 50 ppm based on a quantitative
cancer risk assessment and technological feasibility analysis (See 54
FR 2332, 2432(1989)). This rulemaking was later vacated by court order,
which held that OSHA failed to establish that: (1) the existing PELs
presented a significant risk of material health impairment; (2) the new
standards eliminated or substantially lessened the risk; and (3) the
new PELs were economically or technologically feasible (Ref. 15). As a
result, the PEL for TCE reverted to the original PEL of 100 ppm. The
basis of the 100 ppm PEL is unclear; however, most original PELs were
based on acute health effects only observable at higher concentrations
and did not take into account more sensitive repeated dose studies,
including the studies used to inform the TCE ECEL, that were not
available at the time the PEL was established (see, e.g., 79 FR 61383,
61388). As discussed in Units II.D., III.B., and VIII.D., the TSCA
ECELs for the TCE WCPP are based on the 2020 Risk Evaluation for TCE
and represent the best available science. As described in Unit II.C.1.,
in a 2014 request for information OSHA described how, while new
developments in science and technology from the time the PEL for TCE
was established in 1971 may improve the scientific basis for making
findings of significant risk, technical feasibility, or economic
feasibility that is required under section 6(b)(5) of the OSH Act, OSHA
has been unable to update the PEL for TCE and it remains at the level
that was originally adopted in 1971 (79 FR 61383, October 10, 2014).
5. TCE and Other Occupational Exposure Limits
EPA is aware of other OELs for TCE, including the ACGIH TLV, the
California Division of Occupational Safety and Health (Cal/OSHA) PEL,
and the National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL).
The 8-hour TWA TLV currently recommended by the ACGIH is 10 ppm,
based on a most recent update in 2007. This TLV is based on central
nervous system (CNS) effects occurring at 100 ppm and above (Ref. 16).
Kidney toxicity, cancer, and developmental toxicity were also indicated
at high doses. Overall, the 10 ppm TLV does not seem to be directly
derived from any particular endpoint and can be considered only a semi-
quantitative estimate. The TLV report did not cite either the immune
study used as the basis of EPA's alternative ECEL of 0.0040 ppm (Keil
et al., 2009), nor did it cite Johnson et al., 2003, which is the basis
of EPA's proposed ECEL of 0.0011 ppm. Notably, the most recent TLV
report was released prior to publication of Keil et al., 2009, and the
TLV was not directly derived from any particular endpoint or hazard
value. Among other cited studies that are discussed in the 2020 Risk
Evaluation, the TLV report only discusses LOAELs and did not apply
benchmark dose modeling, PBPK modeling, or any uncertainty factors that
would have contributed to a reduced exposure limit. The report does
identify TCE as a suspected human carcinogen and discusses
epidemiological evidence for several cancers, but there is no
consideration of low-dose linear extrapolation that would have resulted
in a substantially lower TLV.
The current NIOSH REL is based on the ``lowest feasible level''
standard applied to carcinogens, labeled as ``Ca (potential
occupational carcinogen), minimize exposure concentrations'' (Ref. 17),
as well as a 2 ppm 60-minute ceiling REL value when used as an
anesthetic agent and a 25 ppm 10-hour TWA REL for other exposures. As
described in NIOSH's Appendix A, the non-quantitative value applied to
carcinogens is based on the lowest feasible concentration (Ref. 18).
The 25 ppm TWA was based on concerns for CNS effects at higher doses
and a review of industrial hygiene reports supporting the feasibility
of a 25-ppm limit. Notably, this ceiling limit is from 1990, over a
decade before publication of any of the key studies EPA used for risk
determination or ECEL derivation.
The 2007 Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and
equivalent to the NIOSH REL TWA (Ref. 19). According to Cal/OSHA, the
origin of the Cal/OSHA PEL is not clear but is assumed to be based on
the NIOSH REL threshold value, which cited CNS effects and liver cancer
in animals (Ref. 20).
D. Summary of EPA's Risk Evaluation Activities on TCE
In December 2016, EPA selected TCE as one of the first 10 chemicals
for risk evaluation under TSCA section 6 (15 U.S.C. 2605) (81 FR 91927,
December 19, 2016) (FRL-9956-47). EPA published the scope of the TCE
risk evaluation (82 FR 31592, July 7, 2017) (FRL-9963-57), and, after
receiving public comments, published the problem formulation in June
2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In February 2020, EPA
published a draft risk evaluation (85 FR 11079, February 26, 2020)
(FRL-10005-52), and after public comment and peer review by the Science
Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk
Evaluation for TCE in November 2020 in accordance with TSCA section
6(b) (85 FR 75010, November 24, 2020) (FRL-10016-91). EPA subsequently
issued a draft revised TSCA unreasonable risk determination for TCE (87
FR 40520, July 7, 2022) (FRL-9945-01-OCSPP) and after public notice and
receipt of comments, published a final revised Unreasonable Risk
Determination for TCE in January 2023 (88 FR 1222, January 9, 2023)
(FRL-9945-02-OCSPP). The 2020 Risk Evaluation for TCE and supplemental
materials are in docket EPA-HQ-OPPT-2019-0500, with the January 2023
final revised unreasonable risk determination and additional materials
supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0737,
on https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for TCE, EPA evaluated risks associated
with 54 conditions of use within the following categories: manufacture
(including import), processing, distribution in commerce, industrial
and commercial use, consumer use, and disposal (Ref. 1). Descriptions
of these conditions of use are in Unit III.B.1.
The 2020 Risk Evaluation for TCE identified significant adverse
health effects associated with short- and long-term exposure to TCE,
including non-cancer effects (immunosuppression and developmental
toxicity) from acute inhalation exposures and dermal exposures, and
non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity,
autoimmunity, reproductive toxicity, and developmental toxicity) and
cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic
inhalation exposures to TCE. A further discussion of the hazards of TCE
is in Unit III.B.2.
In the 2020 Risk Evaluation for TCE, EPA documented its
unreasonable risk
[[Page 74723]]
policy determination for TCE and based it on the immunotoxicity
endpoint rather than the most sensitive endpoint (developmental
toxicity). The 2020 Risk Evaluation for TCE included a robust
scientific description of the developmental toxicity endpoint,
specifically fetal cardiac defects, and the analysis in the risk
evaluation supporting the developmental toxicity endpoint noted that
this endpoint presents lower PODs (Ref. 1). EPA identified the risk of
fetal cardiac defects most strongly associated with offspring of older
mothers, and therefore included risk estimates for fetal cardiac
defects that account for susceptible mothers and their offspring in
addition to PESS groups with other susceptibilities (e.g., diabetes,
infection status, drug exposure, stress, and metabolic sensitivity due
to increased enzymatic activity of cytochrome P450 2E1 (CYP2E1)) (Ref.
1). EPA recognizes that there are differing views about the
appropriateness of EPA's policy decision in 2020 to use the
immunotoxicity endpoint as the basis for EPA's unreasonable risk
determination. EPA also notes that the endpoint selected as the basis
for the TSCA section 6 unreasonable risk determination in the risk
evaluation that is the basis for this proposed rule should not
necessarily be construed as appropriate for or consistent with the
basis for other Agency assessments such as the Integrated Risk
Information System (IRIS) assessment for TCE or for actions taken by
other agency programs. Further, EPA has received numerous comments on
EPA's 2020 TSCA Risk Evaluation policy choice regarding endpoint
selection that have raised concerns pertaining to political
interference and scientific integrity, among other issues. In
recognition of this history, EPA is therefore requesting comment on the
use of the more sensitive developmental toxicity endpoint to inform TCE
risk management decisions. In particular, EPA notes that this proposed
rule for regulating the unreasonable risk of TCE demonstrates that both
the immunotoxicity and developmental toxicity endpoints support the
proposed prohibitions, discussed in detail in Unit IV.
2. Revised Unreasonable Risk Determination
EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the 2020 Risk Evaluation
for TCE, to ensure that the risk evaluations upon which risk management
decisions are made better align with TSCA's objective of protecting
human health and the environment. For TCE, EPA revised the original
unreasonable risk determination based on the 2020 Risk Evaluation for
TCE and issued a final revised unreasonable risk determination in
January 2023 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for TCE pursuant to TSCA section 6(b) and Executive
Order 13990, (entitled ``Protecting Public Health and the Environment
and Restoring Science to Tackle the Climate Crisis'') and other
Administration priorities (Refs. 21, 22, 23). The revisions consisted
of making the risk determination for the whole chemical substance
rather than for individual conditions of use (which resulted in the
revised risk determination superseding the prior ``no unreasonable
risk'' determinations and withdrawing the associated TSCA section
6(i)(1) ``no unreasonable risk'' order); and clarifying that the risk
determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE. (Ref. 2).
In determining whether TCE presents unreasonable risk under the
conditions of use, EPA considered relevant risk-related factors,
including, but not limited to: the effects of the chemical substance on
health (including cancer and non-cancer risks) and human exposure to
the substance under the conditions of use (including duration,
magnitude, and frequency of exposure); the effects of the chemical
substance on the environment and environmental exposure under the
conditions of use; the population exposed (including any PESS); the
severity of hazard (including the nature of the hazard, the
irreversibility of the hazard); and uncertainties.
EPA determined that TCE presents an unreasonable risk of injury to
health. The unreasonable risk determination, based on immunotoxicity
and cancer, is driven by risks to workers and ONUs (workers who do not
directly handle the chemical but perform work in an area where the
chemical is present) due to occupational exposures to TCE (i.e., during
manufacture, processing, industrial and commercial uses, and disposal);
and to consumers and bystanders associated with consumer uses of TCE
due to exposures from consumer use of TCE and TCE-containing products.
Though the revised unreasonable risk determination was based on cancer
and the best overall non-cancer endpoints for use in risk evaluation
under TSCA (immunosuppression effects for acute inhalation and dermal
exposures, and autoimmunity effects for chronic inhalation and dermal
exposures), consistent with the 2020 Risk Evaluation for TCE, the
Agency is proposing to base the risk management requirements for the
WCPP on a more sensitive endpoint to account for particular health
effects identified in the underlying 2020 Risk Evaluation for TCE
relevant to PESS, as discussed in Unit IV.A. and V.A.2.
EPA did not identify unreasonable risk of injury to the environment
for TCE. The TCE conditions of use that EPA evaluated and whose risk
support EPA's determination that the chemical substance poses
unreasonable risk to health, are listed in the unreasonable risk
determination (Ref. 2) and also in Unit III.B.
3. Fenceline Screening Analysis
The 2020 Risk Evaluation for TCE excluded the assessment of certain
exposure pathways that were or could be regulated under another EPA-
administered statute (see section 1.4.2 of the November 2020 Risk
Evaluation for TCE (Ref. 1). This resulted in the surface water,
drinking water, and ambient air pathways for TCE exposure not being
assessed for human health risk to the general population. In June 2021,
EPA made a policy announcement on the path forward for TSCA chemical
risk evaluations, indicating that EPA would, among other things,
examine whether the exclusion of certain exposure pathways from the
risk evaluations could lead to a failure to adequately protect
fenceline communities (Ref. 24). EPA then conducted a screening
analysis to identify whether there may be risks to people living near
the fenceline of facilities releasing TCE.
In order to assess whether there are no risks of concern or whether
there may be risks of concern to the general population in proximity to
a facility releasing TCE, EPA developed the TSCA Screening Level
Approach for Assessing Ambient Air and Water Exposures to Fenceline
Communities Version 1.0, which was presented to the SACC in March 2022,
with a report issued by the SACC on May 18, 2022 (Ref. 25). This
screening level approach, which EPA believes is very effective in
accurately assessing where fenceline exposures are of no concern is
discussed in Unit VII.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines, through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance
[[Page 74724]]
or mixture, or any combination of such activities, presents an
unreasonable risk of injury to health or the environment, EPA must by
rule apply one or more of the following requirements to the extent
necessary so that the chemical substance or mixture no longer presents
such risk.
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (TSCA section
6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk, so
that TCE no longer presents such unreasonable risk. EPA's proposed
regulatory action and a primary alternative regulatory action are
described in Unit V. EPA is requesting public comment on all elements
of the proposed regulatory action and the alternative regulatory action
and is providing notice that based on consideration of comments and any
new information submitted to EPA during the comment period on this
proposed rule, EPA may in the final rule modify elements of the
proposed regulatory action. The public should understand that public
comments could result in changes to elements of the proposed and
alternative regulatory actions when this rulemaking is finalized. For
example, elements such as timeframes for phase out could be lengthened
or shortened, ECELs could be modified, or the WCPP could have
conditions added or eliminated.
Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption from a requirement of a TSCA section 6(a) rule
for a specific condition of use if EPA finds that: (1) The specific
condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; (2) Compliance with the
requirement, as applied with respect to the specific condition of use,
would significantly disrupt the national economy, national security, or
critical infrastructure; or (3) The specific condition of use, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety. Based on
reasonably available information, EPA has analyzed the need for an
exemption and has found that TSCA section 6(g) exemptions are warranted
for certain conditions of use, as detailed in Unit V.A.3. EPA is
requesting public comment regarding the need for exemptions from the
rule (and under what specific circumstances), including exemptions from
the proposed regulatory action and the primary alternative regulatory
action, pursuant to the provisions of TSCA section 6(g).
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
TSCA section 6(a) rules, to consider and include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. A
description of all TSCA section 6 requirements considered in developing
this proposed regulatory action is in Unit III.B.3., and Unit VI.B.
includes more information regarding EPA's consideration of exemptions
and alternatives. TSCA section 6(c)(2)(C) requires that, in deciding
whether to prohibit or restrict in a manner that substantially prevents
a specific condition of use and in setting an appropriate transition
period for such action, EPA consider, to the extent practicable,
whether technically and economically feasible alternatives that benefit
health or the environment will be reasonably available as substitutes
when the proposed prohibition or restriction takes effect. Unit VI.B.
includes more information regarding EPA's consideration of
alternatives, and Units IV. and VII. provide more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
EPA carried out required consultations as described in this unit
and also considered impacts on children's environmental health as part
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
EPA conducted consultations and outreach in developing this
proposed regulatory action. The Agency held a federalism consultation
from July 22, 2021, until October 22, 2021, as part of this rulemaking
process and pursuant to Executive Order 13132. This included a
background presentation on September 9, 2021, and a consultation
meeting on July 22, 2021. During the consultation, EPA met with State
and local officials early in the process of developing the proposed
action in order to receive meaningful and timely input into its
development (Ref. 26). During the consultation, participants and EPA
discussed preemption; the authority given under TSCA section 6 to
regulate identified unreasonable risk; which activities would be
potentially regulated in the proposed rule; TSCA reporting
requirements; key local constituencies; and the relationship between
TSCA and existing statutes, particularly the Clean Water Act (CWA) and
the Safe Drinking Water Act (SDWA) (Ref. 26).
TCE is not manufactured (including imported), processed,
distributed in commerce, or regulated by Tribal governments. However,
EPA consulted with Tribal officials during the development of this
proposed action (Ref. 27). The Agency held a Tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15 and July 8,
2021. Tribal officials were given the opportunity to meaningfully
interact with EPA risk managers concerning the current status of risk
management. During the consultation, participants and EPA discussed
concerns from Tribal members about the TCE OSHA exposure limit being
outdated, Tribal interest in seeing TCE
[[Page 74725]]
banned, and concerns that third party disposal may be occurring near
Tribal lands, with a particular interest in protecting workers at
publicly owned treatment works (Ref. 27). EPA received no written
comments as part of this consultation.
In addition to the formal consultations, EPA also conducted
outreach to advocates of communities that might be subject to
disproportionate risk from the exposures to TCE, such as communities
with environmental justice concerns. EPA's Environmental Justice (EJ)
consultation occurred from June 3, 2021, through August 20, 2021. On
June 16 and July 6, 2021, EPA held public meetings as part of this
consultation. These meetings were held pursuant to Executive Orders
12898 and 14008. EPA received three written comments following the EJ
meetings, in addition to oral comments provided during the consultation
(Refs. 28, 29, 30). In general, commenters supported strong regulation
of TCE to protect lower-income communities and workers, strong outreach
to affected communities, encouraged EPA to follow the National
Institute for Occupational Safety and Health (NIOSH) hierarchy of
controls, favored prohibitions, and noted the uncertainty, and, in some
cases, inadequacy, of personal protective equipment (Ref. 31).
As required by section 609(b) of the Regulatory Flexibility Act
(RFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to
obtain advice and recommendations from small entity representatives
(SERs) that potentially would be subject to this proposed rule's
requirements (Ref. 32). EPA met with SERs before and during Panel
proceedings, on October 28, 2022, and January 31, 2023. Panel
recommendations are in Unit XI.C. and in the Initial Regulatory
Flexibility Analysis (Ref. 33), the Panel report is in the docket (Ref.
32).
Units XI.C., XI.E., XI.F., and XI.J. provide more information
regarding the consultations.
2. Other Stakeholder Engagement
In addition to the formal consultations described in Unit XI., EPA
held a webinar on December 15, 2020, providing an overview of the TSCA
risk management process and the risk evaluation findings for TCE. EPA
also presented on the risk evaluation and risk management under TSCA
for TCE at a Small Business Administration small business roundtable on
December 18, 2020. At both events EPA staff provided an overview of the
TSCA risk management process and the findings in the 2020 Risk
Evaluation for TCE (Ref. 34). Attendees of these meetings were given an
opportunity to voice their concerns regarding the risk evaluation and
risk management.
Furthermore, EPA engaged in discussions with representatives from
different industries, non-governmental organizations, technical experts
and users of TCE. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 35); meeting
materials and summaries are also in the docket. The purpose of these
discussions was to create awareness and educate stakeholders and
regulated entities on the provisions for risk management required under
TSCA section 6(a); explain the risk evaluation findings; obtain input
from manufacturers, processors, distributors, users, academics,
advisory councils, and members of the public health community about
uses of TCE; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to TCE under the
conditions of use; understand the importance of TCE in the various uses
subject to this proposed rule; compile knowledge about critical uses,
substitute chemicals or alternative methods; identify various standards
and performance specifications; and generate potential risk reduction
strategies. EPA has met with, or otherwise communicated with, a variety
of companies, trade associations and non-governmental public interest
organizations to discuss the topics outlined in this paragraph; a list
of external meetings held during the development of this proposed rule
is in the docket (Ref. 35).
3. Children's Environmental Health
The EPA 2021 Policy on Children's Health (Ref. 36) requires EPA to
protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
early childhood and through adolescence until 21 years of age) and
lifelong health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk
evaluations ``to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' Infants, children, and
pregnant women are listed as examples of subpopulations based on
lifestage that may be considered relevant ``potentially exposed or
susceptible subpopulations'' in the TSCA section 3(12) definition of
that term. In addition, TSCA section 6(a) requires EPA to apply one or
more risk management requirements under TSCA section 6(a) so that TCE
no longer presents an unreasonable risk (including unreasonable risk to
PESS). Furthermore, TSCA 6(c)(2)(B) requires EPA to ``factor in, to the
extent practicable,'' the considerations under TSCA section 6(c)(2)(A)
when selecting among prohibitions and other restrictions in TSCA
section 6(a) rules, including taking into consideration the magnitude
of exposure to human health, as further discussed in Unit IV.
The 2020 Risk Evaluation for TCE evaluated the hazards of TCE to
all lifestages. Evidence of developmental hazards were observed for
increased resorptions, fetal cardiac defects and decreased rearing
activity (i.e., neurotoxicity). These effects occur in the offspring
exposed either in utero or postnatally, with older pregnant women
identified as especially susceptible to cardiac defects in their
developing fetus based on epidemiological data. Adverse health effects
to reproduction following TCE exposure include decreased normal sperm
morphology and hyperzoospermia along with delayed onset of birth. The
most sensitive non-cancer hazard identified for non-reproductive or
developmental effects is autoimmunity following chronic exposure to
TCE.
The 2020 Risk Evaluation for TCE considered impacts on both
children and adults from occupational and consumer use from inhalation
and dermal exposures, as applicable. The 2020 Risk Evaluation for TCE
identified consumers and bystanders associated with use of TCE-
containing consumer products as potentially exposed and susceptible
subpopulations due to greater exposure. Consumer users are considered
to include adults as well as children as young as 11. Bystanders in the
home exposed via inhalation are considered to include any age group
from infant (including breast-fed infants) to adult (including
elderly), including pregnant women and individuals of reproductive age.
Younger lifestages are likely exposed to higher internal dose
concentrations of TCE than adults due to relative physiological
differences in body weight, breathing rate, and other parameters. A
further discussion on the magnitude of health effects and EPA's
consideration of these health effects in this proposed rule is in Unit
IV.
[[Page 74726]]
B. Regulatory Assessment of TCE
1. Description of Conditions of Use
This unit describes the TSCA conditions of use whose risk EPA
evaluated and considered in making its unreasonable risk determination
for the chemical substance TCE. Condition of use descriptions were
obtained from EPA sources such as CDR use codes, the 2020 Risk
Evaluation for TCE and related documents, as well as the Organisation
for Economic Co-operation and Development harmonized use codes and
stakeholder engagements. For additional description of the conditions
of use, including process descriptions and worker activities considered
in the risk evaluation, see the Problem Formulation of the 2020 Risk
Evaluation for TCE, the 2020 Risk Evaluation for TCE, and supplemental
files (Refs. 37, 1, 38). EPA acknowledges that some of the terms used
in this unit may also be defined under other statutes; however, the
descriptions here are intended to provide clarity to the regulated
entities who would be subject to the provisions of this proposed rule
under TSCA section 6(a).
a. Manufacturing
i. Domestic Manufacture
This condition of use refers to the making or producing of a
chemical substance within the United States (including manufacturing
for export), or the extraction of a component chemical substance from a
previously existing chemical substance or a complex combination of
substances. This description does not apply to TCE production as a
byproduct, including during the manufacture of 1,2-dichloroethane,
which EPA intends to consider in the risk evaluation for 1,2-
dichloroethane (Ref. 39).
ii. Import
This condition of use refers to the act of causing a chemical
substance or mixture to arrive within the customs territory of the
United States.
b. Processing
i. Processing as a Reactant/Intermediate
This condition of use refers to processing TCE in chemical
reactions for the manufacturing of another chemical substance or
product, notably including but not limited to 1,1,1,2-
tetrafluoroethane, an HFC also known as HFC-134a, which is used as a
refrigerant and in fluorocarbon blends for refrigerants. This condition
of use includes reuse of byproduct or residual TCE as a reactant.
ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction
Product
This condition of use refers to when TCE is added to a product (or
product mixture) prior to further distribution of the product; such
products include but are not limited to solvents (for cleaning or
degreasing), adhesives and sealant chemicals, and solvents that become
part of a product formulation or mixture (e.g., lubricants and greases,
paints and coatings, other uses).
iii. Processing: Incorporation Into Articles
This condition of use refers to when a chemical substance becomes
an integral component of an article distributed for industrial,
commercial, or consumer use.
iv. Processing: Repackaging
This condition of use refers to the preparation of a chemical
substance for distribution in commerce in a different form, state, or
quantity. This includes but is not limited to transferring the chemical
from a bulk container into smaller containers.
v. Processing: Recycling
This condition of use refers to the process of managing used
solvents that are collected, either on-site or transported to a third-
party site, for commercial purpose other than disposal. Spent solvents
can be restored via solvent reclamation/recycling. The recovery process
may involve an initial vapor recovery or mechanical separation step
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and Commercial Use as Solvent for Open-Top Batch Vapor
Degreasing
This condition of use refers to the process of heating TCE to its
volatilization point and using its vapor to remove dirt, oils, greases,
and other surface contaminants (such as drawing compounds, cutting
fluids, coolants, solder flux, and lubricants) from metal parts,
electronics, or other articles in batch open-top vapor degreasers
(OTVDs).
ii. Industrial and Commercial Use as Solvent for Closed-Loop Batch
Vapor Degreasing
This condition of use refers to the process of heating TCE to its
volatilization point and using its vapor to remove dirt, oils, greases,
and other surface contaminants (such as drawing compounds, cutting
fluids, coolants, solder flux, and lubricants) from metal parts,
electronics, or other articles in batch closed-loop vapor degreasers.
iii. Industrial and Commercial Use as Solvent for In-Line Conveyorized
Vapor Degreasing
This condition of use refers to the process of heating TCE to its
volatilization point and using its vapors to remove dirt, oils,
greases, and other surface contaminants from textiles, glassware, metal
surfaces, and other articles using in-line conveyorized degreasing
machines.
iv. Industrial and Commercial Use as Solvent for In-Line Web Cleaner
Vapor Degreasing
This condition of use refers to the process of heating TCE to its
volatilization point and using its vapors to remove dirt, oils,
greases, and other surface contaminants from textiles, glassware, metal
surfaces, and other articles using in-line web cleaning degreasing
machines.
v. Industrial and Commercial Use as Solvent for Cold Cleaning
This condition of use refers to the industrial and commercial use
of TCE as a non-boiling solvent in cold cleaning to dissolve oils,
greases and other surface contaminants from textiles, glassware, metal
surfaces, and other articles.
vi. Industrial and Commercial Use as a Solvent for Aerosol Spray
Degreaser/Cleaner and Mold Release
This condition of use refers to industrial and commercial use of
TCE in aerosol degreasing as an aerosolized solvent spray, typically
applied from a pressurized can, to remove residual contaminants from
fabricated parts or machinery (including circuit boards and
electronics). This description also applies to the use of TCE in
products to remove dirt, grease, stains, spots, and foreign matter,
including but not limited to release agent residues, from molds and
casting surfaces.
vii. Industrial and Commercial Use as a Lubricant and Grease in Tap and
Die Fluid
This condition of use refers to industrial and commercial use of
TCE in products such as, but not limited to, metalworking, cutting, and
tapping fluid to reduce friction, heat generation and wear, to assist
in metal shaping, and to protect the part being shaped from oxidation.
This description does not apply to use of TCE in products intended as
penetrating lubricant, which are described in a different condition of
use.
[[Page 74727]]
viii. Industrial and Commercial Use as a Lubricant and Grease in
Penetrating Lubricant
This condition of use refers to the industrial and commercial use
of TCE in products as a lubricant and grease in penetrating lubricant,
to reduce friction, heat generation and wear between surfaces. This
description does not apply to use of TCE in products intended as
metalworking, cutting and tapping fluids, which are described in a
different condition of use.
ix. Industrial and Commercial Use as an Adhesive and Sealant in
Solvent-Based Adhesives and Sealants; Tire Repair Cement/Sealer; Mirror
Edge Sealant
This condition of use refers to industrial and commercial use of
TCE in adhesive and sealant products to promote bonding between other
substances, promote adhesion of surfaces, or prevent seepage of
moisture or air.
x. Industrial and Commercial Use as a Functional Fluid in Heat Exchange
Fluid
This condition of use refers to the industrial and commercial use
of TCE as a functional fluid in heat exchange fluid used to transmit or
to remove heat from another material in a closed system.
xi. Industrial and Commercial Use in Paints and Coatings as a Diluent
in Solvent-Based Paints and Coating
This condition of use refers to industrial and commercial use of
TCE in paints and coatings that are applied to surfaces to enhance
properties such as, but not limited to, water repellency, gloss, fade
resistance, ease of application, or foam prevention.
xii. Industrial and Commercial Use in Cleaning and Furniture Care
Products in Carpet Cleaner and Wipe Cleaning
This condition of use refers to the industrial and commercial use
of TCE in products to remove dirt, grease, stains, spots, and foreign
matter from furniture and furnishings, including but not limited to
carpets and rugs. This description also applies to use of TCE in
degreasing and cleaning products to remove dirt, grease, stains, spots,
and foreign matter from furniture and furnishings or to cleanse,
sanitize, bleach, scour, polish, protect, or improve the appearance of
surfaces through wipe cleaning. This description does not apply to the
use of TCE as a spot remover for laundry and dishwashing, which is
described in a different condition of use.
xiii. Industrial and Commercial Use in Laundry and Dishwashing Products
in Spot Remover
This condition of use refers to industrial and commercial use of
TCE as a solvent in products for cleaning in laundry and dishwashing
applications to remove dirt, grease, stains, spots, and foreign matter
from garments and dishware.
xiv. Industrial and Commercial Use in Arts, Crafts, and Hobby Materials
in Fixatives and Finishing Spray Coatings
This condition of use refers to the industrial and commercial use
of TCE in aerosol products, such as, but not limited to, fixatives,
shellacs, or other spray applied coatings intended to cover or hold
other arts and crafts materials to a surface.
xv. Industrial and Commercial Use in Corrosion Inhibitors and Anti-
Scaling Agents
This condition of use refers to the industrial and commercial use
of TCE in corrosion inhibitors and anti-scaling agents as a chemical
substance used to prevent or retard corrosion or the formation of
scale. As a corrosion inhibitor, TCE is used to prevent or retard
corrosion on metallic materials. As an anti-scaling agent, TCE is added
to products to prevent the build-up of inorganic oxide deposits.
xvi. Industrial and Commercial Use in Processing Aids in Process
Solvent Used in Battery Manufacture; Process Solvent Used in Polymer
Fabric Spinning, Fluoroelastomer Manufacture and Alcantara Manufacture;
Extraction Solvent Used in Caprolactam Manufacture; Precipitant Used in
Beta-Cyclodextrin Manufacture
This condition of use refers to industrial and commercial use of
TCE as a processing aid. A process solvent is a chemical substance used
to improve the processing characteristics or the operation of process
equipment when added to a process or to a substance or mixture to be
processed. The chemical substance is not intended to become a part of
the reaction product nor has function in the reaction product.
xvii. Industrial and Commercial Use as Ink, Toner, and Colorant
Products in Toner Aid
This condition of use refers to the industrial and commercial use
of TCE in ink, toner, and colorant products in toner aid as chemical
substance used for writing, printing, creating an image on paper and
other substrates, or applied to substrates to change their color or
hide images. This includes but is not limited to pigmented liquids,
toners or powders contained in cartridges, bottles, or other dispensers
used in printers and copy machines. This category includes printing
inks for commercial applications.
xviii. Industrial and Commercial Use in Automotive Care Products in
Brake and Parts Cleaner
This condition of use refers to the industrial and commercial use
of TCE in products to remove dirt, grease, stains, and foreign matter
from interior and exterior vehicle surfaces. This description includes
but is not limited to use of products for motorized vehicle maintenance
and their parts.
xix. Industrial and Commercial Use in Apparel and Footwear Care
Products in Shoe Polish
This condition of use refers to the industrial or commercial use of
TCE in apparel and footwear care products as post-market waxes,
polishes, or other mediums and applied to footwear, textiles, or
fabrics to impart color or other desirable properties.
xx. Industrial and Commercial Use in Hoof Polish, Gun Scrubber, Pepper
Spray, Other Miscellaneous Industrial and Commercial Uses
This condition of use refers to the industrial and commercial use
of TCE in which it is expected to act similar to a cleaning solvent
used to remove dirt or other contaminants from substrates. This
description also refers to other miscellaneous products which contain
TCE as an additive to impart or enhance desirable properties of another
material (e.g., adhesive, sealant, propellant). Additionally, this
condition of use refers to the industrial and commercial use of TCE,
often in small quantities, in a laboratory for chemical analysis (e.g.,
to test hot mix asphalt binder content, as a reference standard, etc.),
chemical synthesis, extracting and purifying other chemicals,
dissolving other substances, and similar activities.
d. Consumer Use
i. Consumer Use as a Solvent in Brake and Parts Cleaner
This condition of use refers to the consumer use of TCE in products
to remove dirt, grease, stains, and foreign matter from interior and
exterior vehicle surfaces, particularly in brake cleaner and parts
cleaner.
ii. Consumer Use as a Solvent in Aerosol Electronic Degreaser/Cleaner
This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used
[[Page 74728]]
to remove dirt, grease, stains, spots, and foreign matter through a
process that uses an aerosolized solvent spray, typically applied from
a pressurized can, to remove residual contaminants from electronics.
iii. Consumer Use as a Solvent in Liquid Electronic Degreaser/Cleaner
This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses a
liquid solvent to remove residual contaminants from electronics.
iv. Consumer Use as a Solvent in Aerosol Spray Degreaser/Cleaner
This condition of use refers to the consumer use of TCE as a
solvent in degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses
an aerosolized solvent spray, typically applied from a pressurized can,
to remove residual contaminants from metals and other fabricated
materials not described elsewhere in this unit.
v. Consumer Use as a Solvent in Liquid Degreaser/Cleaner
This condition of use refers to the consumer use of TCE as a
solvent in liquid degreasing and cleaning products used to remove dirt,
grease, stains, spots, and foreign matter from metals and other
fabricated materials not described elsewhere.
vi. Consumer Use as a Solvent in Aerosol Gun Scrubber
This condition of use refers to the consumer use of TCE as a
solvent in aerosol products in which it is expected to act similar to a
cleaning solvent used to remove residue, dirt, grease, or other
contaminants, in particular but not limited to gun scrubber.
vii. Consumer Use as a Solvent in Liquid Gun Scrubber
This condition of use refers to the consumer use of TCE as a
solvent in liquid products in which it is expected to act similar to a
cleaning solvent used to remove residue, dirt, grease, or other
contaminant, in particular but not limited to gun scrubber.
viii. Consumer Use as a Solvent in Mold Release
This condition of use refers to the consumer use of TCE in mold
release products to create barriers to prevent certain materials from
adhering to each other, and assist in the removal of dirt, grease,
oils, and other contaminants from metal molds.
ix. Consumer Use as a Solvent in Aerosol Tire Cleaner
This condition of use refers to the consumer use of TCE as an
additive in aerosol products to impart or enhance desirable properties
of another material, particularly in use as tire cleaner.
x. Consumer Use as a Solvent in Liquid Tire Cleaner
This condition of use refers to the consumer use of TCE as an
additive in liquid products to impart or enhance desirable properties
of another material, particularly in use as tire cleaner.
xi. Consumer Use as a Lubricant and Grease in Tap and Die Fluid
This condition of use refers to the consumer use of TCE in products
to reduce friction, heat generation and wear between solid surfaces,
particularly in tap and die fluid.
xii. Consumer Use as a Lubricant and Grease in Penetrating Lubricant
This condition of use refers to the consumer use of TCE in products
to reduce friction, heat generation and wear between solid surfaces,
particularly in penetrating lubricant.
xiii. Consumer Use as an Adhesive and Sealant in Solvent-Based Adhesive
and Sealants
This condition of use refers to the consumer use of TCE as a
solvent in single or two component products used to fasten other
materials together or prevent the passage of liquid or gas. This
description does not apply to products for mirror edge sealant or tire
repair, which are described in different conditions of use.
xiv. Consumer Use as an Adhesive and Sealant in Mirror Edge Sealant
This condition of use refers to the consumer use of TCE in single
or two component products used to fasten other materials together or
prevent the passage of liquid or gas, particularly in mirror edge
sealant.
xv. Consumer Use as an Adhesive and Sealant in Tire Repair Cement/
Sealer
This condition of use refers to the consumer use of TCE in single
or two component products used to fasten other materials together or
prevent the passage of liquid or gas, particularly in cement or sealant
for tire repair.
xvi. Consumer Use as a Cleaning and Furniture Care Product in Carpet
Cleaner
This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products used to remove dirt,
grease, stains, spots, foreign matter, and residual contaminants,
particularly in carpet cleaner.
xvii. Consumer Use as a Cleaning and Furniture Care Product in Aerosol
Spot Remover
This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products used to remove dirt,
grease, stains, spots, and foreign matter through a process that uses
an aerosolized solvent spray, typically applied from a pressurized can,
to remove residual contaminants, particularly in aerosol spot remover.
xviii. Consumer Use as a Cleaning and Furniture Care Product in Liquid
Spot Remover
This condition of use refers to the consumer use of TCE as a
solvent in cleaning and furniture care products in the form of a solid
or liquid cleaner, used to remove dirt, grease, stains, spots, foreign
matter, and residual contaminants, particularly in liquid spot remover.
xix. Consumer Use in Arts, Crafts, and Hobby Materials in Fixative and
Finishing Spray Coatings
This condition of use refers to the consumer use of TCE in arts,
crafts, and hobby products that uses an aerosolized solvent spray,
typically applied from a pressurized can, intended to cover or hold
other arts and crafts materials to a surface, particularly in fixative
and finishing spray coatings.
xx. Consumer Use in Apparel and Footwear Products in Shoe Polish
This condition of use refers to the consumer use of TCE in apparel
and footwear care products as post-market waxes, polishes, or other
mediums and applied to footwear, textiles, or fabrics to impart color
or other desirable properties.
xxi. Consumer Use in Fabric Spray
This condition of use refers to the consumer use of TCE in aerosol
products, typically applied from a pressurized can, as an additive to
enhance desirable properties of another material, particularly in
fabric spray and as an anti-fray spray.
[[Page 74729]]
xxii. Consumer Use in Film Cleaner
This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in film cleaner.
xxiii. Consumer Use in Hoof Polish
This condition of use refers to the consumer use of TCE as an
additive to impart or enhance desirable properties of another material,
particularly in hoof polish.
xxiv. Consumer Use in Toner Aid
This condition of use refers to the consumer use of TCE in products
as an additive to impart or enhance the desirable properties of another
material, particularly in toner aid.
e. Disposal
This condition of use refers to the process of disposing of
generated waste streams of TCE that are collected either on-site or
transported to a third-party site. This includes the mixing of TCE with
wastewater and the discharge of TCE-contaminated wastewater pursuant to
a NPDES permit, and specifically includes discharge to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
While EPA views the disposal condition of use under TSCA broadly (see,
e.g., EPA's proposed regulation on certain conditions of use of
chrysotile asbestos (Ref. 40), for the purpose of this rulemaking under
TSCA section 6(a), based on the underlying analysis in the 2020 TCE
risk evaluation, EPA's proposed regulations specifically address the
risk to PESS from disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works. EPA recognizes
that this includes activities that may not be considered disposal under
other statutes, such as RCRA and the CWA.
f. Terminology in This Proposed Rule
For purposes of this proposed rulemaking, ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for TCE for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority over ``any manner or method of
commercial use'' under TSCA section 6(a)(5) to reach both.
Additionally, in the 2020 Risk Evaluation for TCE, EPA identified
and assessed all known, intended, and reasonably foreseen industrial,
commercial, and consumer uses of TCE in order to determine whether TCE
as a whole chemical substance presents unreasonable risk to health and
the environment. EPA determined that a substantial amount of the
industrial, commercial, and consumer uses of TCE evaluated in the 2020
Risk Evaluation for TCE present unreasonable risk of injury to health.
As such, for purposes of this risk management rulemaking, ``consumer
use'' refers to all consumer uses including known, intended, and
reasonably foreseen consumer uses for TCE. Likewise, for the purpose of
this risk management rulemaking ``industrial and commercial use''
refers to all industrial and commercial uses, including known,
intended, or reasonably foreseen TCE industrial and commercial use.
EPA is not proposing to incorporate the descriptions of known,
intended, or reasonably foreseen conditions of use in Unit III.B.1.a.
through e. into the regulatory text as definitions because these
conditions of use represent those evaluated in the 2020 Risk Evaluation
for TCE, whereas the regulatory text applies to all consumer and
industrial/commercial uses. EPA requests comment on whether EPA should
promulgate definitions for those conditions of use evaluated in the
2020 Risk Evaluation for TCE, and, if so, whether the descriptions in
this unit are consistent with the conditions of use evaluated in the
2020 Risk Evaluation for TCE and whether they provide a sufficient
level of detail to improve the clarity and readability of the
regulation if EPA were to promulgate a regulation controlling
industrial and commercial conditions of use that pertained only to the
listed industrial and commercial conditions of use evaluated in the
2020 Risk Evaluation for TCE.
EPA further notes that this proposed rule does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but
are not limited to, any pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured,
processed, or distributed in commerce for use as a pesticide; and any
food, food additive, drug, cosmetic, or device, as defined in section
201 of the Federal Food, Drug, and Cosmetic Act (FFDCA), when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic or device.
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that TCE presents an unreasonable risk of injury
to human health under the conditions of use based on acute and chronic
non-cancer risks and chronic cancer risks (Ref. 2). As described in the
TSCA section 6(b) 2020 Risk Evaluation for TCE, EPA identified non-
cancer adverse effects from acute and chronic inhalation and dermal
exposures to TCE, and for cancer from chronic inhalation and dermal
exposures to TCE (Ref. 1). In the TCE risk characterization, the
endpoints identified by EPA as the basis for the unreasonable risk
determination in the Risk Conclusions were immunosuppression effects
for acute inhalation and dermal exposures, and autoimmunity effects for
chronic inhalation and dermal exposures (Ref. 1). Additional risks
associated with other non-cancer adverse effects (e.g., developmental
toxicity, immunosuppression, liver toxicity, kidney toxicity,
neurotoxicity, autoimmunity, and reproductive toxicity) were identified
for acute and chronic inhalation and dermal exposures, as well as
cancer (liver, kidney, and non-Hodgkin lymphoma) for chronic inhalation
and dermal exposures. EPA also concluded, based on EPA's Guidelines for
Carcinogen Risk Assessment (Ref. 41), that TCE is considered to be
carcinogenic by all routes of exposure and calculated cancer risks from
chronic inhalation and dermal exposures (Ref. 1). Unit IV. summarizes
the health effects and the magnitude of the exposures.
To make the unreasonable risk determination for TCE, EPA evaluated
exposures to potentially exposed or susceptible subpopulations
including workers, ONUs, consumer users, and bystanders to consumer use
by using reasonably available monitoring and modeling data for
inhalation and dermal exposures. (Ref. 1). EPA conducted a screening-
level analysis to assess potential risks from the air and water
pathways to fenceline communities. A discussion of EPA's analysis and
the expected effects of this rulemaking on fenceline communities is in
Unit VII.A.
For the 2020 Risk Evaluation for TCE, and as discussed in Unit
II.D.1. and Unit III.A.3., EPA considered PESS. EPA identified the
following groups as PESS: workers and ONUs, including men and women of
reproductive age, adolescents, and biologically susceptible
subpopulations; and consumer users (age 11 and older) and bystanders
(of any age group, including infants, toddlers, children, and elderly),
including biologically susceptible subpopulations. Additionally, older
pregnant women are identified as especially susceptible to cardiac
defects in their developing fetus based on
[[Page 74730]]
epidemiological data (Ref. 1). All PESS are included in the
quantitative and qualitative analyses described in the 2020 Risk
Evaluation for TCE and were considered in the determination of
unreasonable risk for TCE (Ref. 1, 2). As discussed in Unit II.D. and
Unit IV.B., the 2020 Risk Evaluation for TCE excluded the air and water
exposure pathways to the general population from the published risk
evaluations and may have caused some risks to be unaccounted for in the
risk evaluation. EPA considers these groups a subset of the general
population and categorizes them as fenceline communities; they may also
be considered PESS. See Unit VII.A. for further discussion on assessing
and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to address the
unreasonable risk for TCE.
As required, EPA developed a proposed regulatory action and one or
more primary alternative regulatory actions, which are described in
Units V.A. and V.B., respectively. To identify and select a regulatory
action, EPA considered the two routes of exposure driving the
unreasonable risk, inhalation and dermal, and the exposed populations.
For occupational conditions of use (see Unit III.B.1.f.), EPA
considered how it could directly regulate manufacturing (including
import), processing, distribution in commerce, industrial and
commercial use, or disposal to address the unreasonable risk. EPA does
not have direct authority to regulate consumer use. Therefore, EPA
considered how it could exercise its authority under TSCA to regulate
the manufacturing (including import), processing, and/or distribution
in commerce of TCE at different points in the supply chain to eliminate
exposures or restrict the availability of TCE and TCE-containing
products for consumer use in order to address the unreasonable risk.
As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions the effects of TCE on
health, which is described in Unit IV. EPA also factored into its
decisions, to the extent practicable: the effects of TCE on the
environment and the magnitude of exposure to TCE of human beings and
the environment, the benefits of TCE for various uses, and the
reasonably ascertainable economic consequences of the rule. In
evaluating the reasonably ascertainable economic consequences of the
rule, EPA considered: (i) The likely effect of the rule on the national
economy, small business, technological innovation, the environment, and
public health; (ii) The costs and benefits of the proposed regulatory
action and one or more primary alternative regulatory actions
considered; and (iii) The cost effectiveness of the proposed regulatory
action and of the one or more primary alternative regulatory actions
considered. See Unit VII. for further discussion related to TSCA
section 6(c)(2)(A) considerations, including the statement of effects
of the proposed rule with respect to these considerations.
EPA also considered the regulatory authority under TSCA and other,
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and
other EPA-administered statutes, to examine: (1) Whether there are
opportunities for all or part of risk management action on TCE to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or section 9(b); or (2) Whether TSCA section
6(a) regulation could include alignment of requirements and definitions
in and under existing statutes to minimize confusion to the regulated
entities and the general public.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit VI.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory action in Unit V.).
To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy of controls adopted by OSHA and NIOSH, with the goal of
identifying risk management control methods that are permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated entities
where appropriate. EPA considered the information presented in the 2020
Risk Evaluation for TCE, as well as additional input from stakeholders
(as described in Unit III.A.), and anticipated compliance strategies
from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory actions described
in Unit V. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit
VI.
IV. Considerations of Health Effects of TCE
TSCA section 6(a) rules must be promulgated ``in accordance with
subsection (c)(2).'' TSCA section 6(c)(2)(A) requires EPA, in proposing
and promulgating TSCA section 6(a) rules, to ``consider and publish a
statement based on reasonably available information'' with respect to
listed criteria, including the effects and magnitude of exposure to
human health and the environment, the benefits of the chemical
substance for various uses, and the reasonably ascertainable economic
consequences of the rule. Under TSCA section 6(c)(2)(B), EPA must
``factor in, to the extent practicable,'' the considerations under TSCA
section 6(c)(2)(A) when selecting among prohibitions and other
restrictions in TSCA section 6(a) rules. This section discusses the
health effects of TCE. Other TSCA section 6(c)(2) considerations are
discussed further in Unit VII.
EPA's analysis of the health effects of TCE is in the 2020 Risk
Evaluation (Ref. 1). This unit presents a summary of that information
and an explanation of how EPA considered that information in developing
the proposed and alternative regulatory options.
TCE has a large database of human health toxicity data. The 2020
Risk Evaluation for TCE identified several endpoints, such as kidney
toxicity, immunotoxicity, or developmental toxicity, and often a single
endpoint was examined by multiple studies. For acute exposures, EPA
identified non-cancer effects (developmental toxicity and
immunosuppression). For chronic exposures, EPA identified non-cancer
effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity,
reproductive toxicity, and developmental toxicity) as well as cancer
(liver, kidney, and non-Hodgkin lymphoma), with kidney cancer
identified as acting through a mutagenic mode of action (Ref. 1). As
discussed in this unit, the 2020 Risk Evaluation for TCE contains
quantitative risk estimates using several points of departure (PODs),
including both the immunotoxicity endpoints as well as the more
sensitive developmental toxicity endpoints, specifically fetal cardiac
defects, and both demonstrate that TCE presents risk.
Additionally, in developing the 2020 Risk Evaluation for TCE, EPA
analyzed
[[Page 74731]]
the reasonably available information to ascertain whether some human
subpopulations may have greater exposure or greater susceptibility than
the general population to the hazard posed by the chemical substance.
Factors affecting susceptibility examined in the reasonably available
studies on TCE include lifestage, sex, genetic polymorphisms, race/
ethnicity, preexisting health status, lifestyle factors, and nutrition
status. Groups of individuals for which one or several of these factors
apply may be considered PESS (Ref. 1).
A. ECEL Value of 0.0011 ppm Based on Developmental Toxicity (Proposed)
Because TSCA section 6(c)(2)(B) directs EPA to factor in, to the
extent practicable, the health effects of TCE under TSCA section
6(c)(2)(A), TSCA section 6(c) thereby provides EPA with the flexibility
to tailor the regulatory restrictions to account for particular health
effects identified in the underlying risk evaluation. With this
consideration, EPA found that, in some cases, a regulatory option that
could reduce exposures such that they would achieve the benchmark
margin of exposure for the most sensitive non-cancer endpoint
(developmental toxicity) would address any risk for other non-cancer
endpoints. Older pregnant workers and ONUs, who may be especially
susceptible to TCE- induced cardiac defects in their developing fetus,
are classified as a PESS, and the associated POD and risk estimates
were included in the 2020 Risk Evaluation in consideration of PESS
groups. EPA has carefully considered the health effects of TCE on
pregnant workers and ONUs as part of the Agency's development of
proposed requirements that would be applicable to certain occupational
conditions of use of TCE. In order for this rulemaking to appropriately
address risk to all workers and ONUs exposed to TCE through the
occupational conditions of use for which EPA is proposing an ECEL
associated with a WCPP, EPA has factored in consideration of additional
health effects applicable to PESS, including older pregnant workers and
ONUs (the group identified as most susceptible to fetal cardiac
defects) pursuant to TSCA section 6(c)(2), and is proposing an ECEL
value of 0.0011 ppm based on developmental toxicity (Ref. 13).
In the risk characterization section of the 2020 Risk Evaluation
for TCE, EPA acknowledged that fetal cardiac defects are an acute, non-
cancer endpoint of concern for older pregnant women, while also
acknowledging uncertainty surrounding the use of this endpoint to
inform the determination of whether TCE presents unreasonable risk of
injury to health for all affected human populations. In the 2020 Risk
Evaluation for TCE, EPA presented the Agency's findings with respect to
different endpoints and characterized the immunotoxicity endpoints as
the ``best overall'' non-cancer endpoints for use in the risk
conclusions and risk determination. The endpoints were characterized in
this way precisely because of the quantitative uncertainties
surrounding the use of the fetal cardiac defects endpoint and other
considerations. Further, as noted in Unit II.D.1., EPA has received
numerous comments on EPA's 2020 TSCA Risk Evaluation policy choice
regarding endpoint selection that have raised concerns pertaining to
political interference and scientific integrity, among other issues.
Among the non-cancer adverse health effects, the drivers for EPA's
whole chemical unreasonable risk determination for TCE under TSCA were
identified as immunotoxicity, acute immunosuppression, and chronic
autoimmunity from inhalation and dermal exposures (Ref. 2). EPA
received significant feedback on this aspect of the 2020 Risk
Evaluation for TCE, including focused attention on this issue from the
SACC and public commenters reacting to the draft Risk Evaluation for
TCE (Ref. 42). Moreover, based on the discussion included in the peer
review report of the 2020 Risk Evaluation, EPA also concluded that
reasonable scientists would not disallow the use of the fetal cardiac
defects studies, and that therefore other EPA program reliance on the
fetal cardiac defects endpoint is scientifically valid (e.g., IRIS).
The 2020 Risk Evaluation for TCE identified the developmental
toxicity endpoint of fetal cardiac defects, which presents a lower POD
than the immunotoxicity endpoints. The magnitude of the unreasonable
risk from exposures to TCE would have been greater had the Agency
relied upon the developmental toxicity endpoint (Ref. 1). Specifically,
EPA identified the risk of fetal cardiac defects most strongly
associated with offspring of older mothers, and therefore included risk
estimates for fetal cardiac defects that account for susceptible
mothers and their offspring in addition to PESS groups with other
susceptibilities (e.g., diabetes, infection status, drug exposure,
stress, and metabolic sensitivity due to increased enzymatic activity
of cytochrome P450 2E1 (CYP2E1) (Ref. 1).
EPA developed the ECEL for the most sensitive health endpoint
(developmental toxicity) in support of risk management efforts on TCE
under TSCA, to identify that ambient exposures that are kept at or
below the 8-hour ECEL of 0.0011 ppm would protect against risk of
injury to health due to fetal cardiac defects, if those levels can be
achieved. In addition, EPA expects that at the acute non-cancer ECEL of
0.0011 ppm, any potentially exposed person in the workplace would be
protected against other non-cancer effects resulting from occupational
exposures, as well as excess risk of cancer (Ref. 13). EPA expects that
if a facility were able to meet the ECEL (0.0011 ppm) requirement
associated with the WCPP under the proposed regulatory action outlined
in Unit V.A.2., it would protect PESS during the phaseout period before
the full prohibition.
B. ECEL Value of 0.0040 ppm Based on Immunotoxicity (Primary
Alternative)
In other risk management actions under TSCA section 6, EPA has
proposed basing its worker protection requirements, such as an ECEL, on
a single acute or chronic exposure endpoint that provided the basis for
the unreasonable risk determination (Ref. 40). While EPA is proposing a
different basis for the ECEL for the WCPP for TCE (0.0011 ppm) (to
protect a sensitive PESS), EPA recognizes that among the non-cancer
adverse health effects of TCE, the drivers for EPA's whole chemical
unreasonable risk determination for TCE under TSCA were identified as
immunotoxicity, namely acute immunosuppression and chronic autoimmunity
from inhalation and dermal exposures (Ref. 2). For this reason, the
primary alternative regulatory action provided by EPA includes a WCPP
with a different ECEL (0.0040 ppm), based on the endpoint that drives
the unreasonable risk. As described in more detail in Unit V.B.2.,
reducing exposures to or below the ECEL of 0.0040 ppm would address
that component of the unreasonable risk of injury to health from TCE
that is driven by inhalation exposures in an occupational setting
(Refs. 1, 14). If ambient exposures are kept at or below the 8-hour
ECEL of 0.0040 ppm, EPA expects that workers and ONUs would be
protected against not only the chronic non-cancer effects for
autoimmunity described in this unit, but also effects resulting from
acute non-cancer exposure (immunosuppression) and cancer.
As described in Unit V.A.2., for the ECEL value of 0.0011 ppm,
proposed as
[[Page 74732]]
part of the WCPP, EPA requests comment on the use of TSCA section
6(c)(2) to tailor the risk management actions where necessary to
protect PESS. Also, as described in Unit V.B.2., EPA is requesting
comment on the use of the ECEL value of 0.0040 ppm in the WCPP in the
alternative regulatory action. Specifically, EPA is requesting comment
on the selection of the fetal cardiac defects endpoint for the ECEL of
0.0011 ppm in the proposed regulatory action, rather than the
immunotoxicity endpoint on which the unreasonable risk determination is
based, which would result in an ECEL of 0.0040 ppm. EPA is also
requesting comment on additional ways to protect workers and ONUs who
are or may become pregnant.
V. Proposed and Primary Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
TCE will no longer present an unreasonable risk of injury to health. In
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost effectiveness of the proposed
regulatory action and one or more primary alternative regulatory
actions. In the case of TCE, the proposed regulatory action is
described in Unit V.A. and the primary alternative regulatory action
considered is described in Unit V.B. An overview of the proposed
regulatory action and primary alternative regulatory action for each
condition of use is in Unit V.C. The rationale for the proposed and
primary alternative regulatory actions and associated compliance
timeframes are discussed in this unit and in more detail in Unit VI.A.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to: Prohibit all
manufacture (including import), processing, distribution in commerce,
and industrial and commercial use of TCE for all uses (including all
consumer uses), with longer timeframes and workplace controls for
certain processing and industrial and commercial uses (including
proposed phaseouts and TSCA section 6(g) exemptions); prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works with a 50-year TSCA section 6(g)
exemption for cleanup projects; and establish recordkeeping and
downstream notifications requirements. Prohibitions on manufacturing
(including import) and processing, including staggered implementation
timeframes to account for the supply chain, are outlined in Unit
V.A.1.a.; prohibitions on industrial and commercial uses and
distribution in commerce are outlined in Unit V.A.1.b.; and
prohibitions related to consumer uses are outlined in Unit V.A.1.c.
EPA is proposing longer compliance timeframes (with workplace
controls) for prohibitions on certain conditions of use. The timeframe
for a prohibition or phaseout under TSCA section 6(d) must begin as
soon as practicable, but not later than 5 years, with the full
implementation of the prohibition or phase-out requirements occurring
as soon as practicable and providing for a reasonable transition
period. For a TSCA section 6(g) exemption for a specific condition of
use, EPA must establish a time limit as reasonable on a case-by-case
basis as long as the exemption meets the criteria under TSCA section
6(g)(1). First, EPA is proposing to prohibit the manufacturing
(including import) and processing of TCE as an intermediate for the
manufacture of HFC-134a through an 8.5-year phaseout, as outlined in
Unit V.A.1.d. Second, EPA is proposing a 10-year phaseout for the
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production for Federal agencies and their contractors,
conditioned on a final pre-launch test within 5 years of rocket booster
nozzles that have been produced without using TCE, as outlined in Unit
V.A.1.e. Third, EPA is proposing a time-limited exemption for 10 years
under a TSCA section 6(g) exemption related to prohibitions on the
industrial and commercial use of TCE as a processing aid for battery
separator manufacturing, as outlined in Unit V.A.3.b.i. Fourth, EPA is
proposing a time-limited exemption for 10 years under a TSCA section
6(g) exemption related to prohibitions on industrial uses of TCE for
DoD vessel requirements for potting, bonding and sealing compounds, and
bonding and cleaning requirements for naval combat systems, radars,
sensors, equipment, and fabrication and prototyping processes, as
outlined in Unit V.A.3.b.ii. Fifth, EPA is proposing a time-limited
exemption for 50 years under a TSCA section 6(g) exemption related to
prohibitions on the industrial and commercial use of TCE in laboratory
use for essential laboratory activities and some research and
development activities, as outlined in Unit V.A.3.b.iii. Sixth, EPA is
proposing a time-limited exemption for 7 years under a TSCA section
6(g) exemption related to prohibitions on the industrial and commercial
use of TCE as a solvent in closed loop vapor degreasing necessary for
human-rated rocket engine cleaning by NASA and its contractors.
Seventh, EPA is proposing a time-limited exemption for 10 years under a
TSCA section 6(g) exemption for emergency industrial and commercial use
of TCE for specific conditions of use which are critical or essential
in furtherance of NASA's mission and for which no technically and
economically safer alternative is available. Where conditions of use
would be prohibited under timeframes longer than one year, EPA's
proposal aims to align with elements of existing OSHA regulations and
industrial hygiene best practices to the extent possible by
implementing a Workplace Chemical Protection Program (WCPP). The WCPP
includes requirements for an inhalation exposure limit and glove
requirements to limit exposure to TCE until the prohibitions take
effect, as outlined in Unit V.A.2. Lastly, EPA is proposing to prohibit
certain disposal of TCE (specifically, the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works), as outlined in Unit V.A.1.f., with a time limited 50-
year exemption for cleanup projects as outlined in Unit V.A.3.b.iv; and
establish recordkeeping and downstream notification requirements, as
outlined in Unit V.A.4. EPA requests comment on the applicability to
the private sector of proposed regulatory actions pertaining
specifically to Federal agencies, namely industrial uses for DoD vessel
requirements and closed-loop batch vapor degreasing for rayon fabric
scouring for rocket booster nozzle production. EPA requests comment on
the extent to which the private sector would be affected by a
prohibition on these uses.
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce,
Use, and Disposal
a. Prohibitions on Manufacturing (Including Import) and Processing of
TCE
EPA is proposing to prohibit the manufacturing (including import)
and processing of TCE based on the unreasonable risk to workers and
ONUs driven by these conditions of use (Ref. 2). As the manufacture and
processing of TCE presents and unreasonable risk to health in the
United States, the manufacture and processing of TCE for export would
also be prohibited in accordance with TSCA section 12(a)(2).
As discussed in Units III.B.3. and VI.A., based on the Agency's
consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty
[[Page 74733]]
relative to the feasibility of exposure reduction to sufficiently
address the unreasonable risk across the broad range of occupational
environments and activities that occur in manufacturing (including
import) and processing conditions of use, and the irreversible health
effects associated with TCE exposures, EPA has determined that
prohibition is the best way to address the unreasonable risk.
EPA is proposing that the prohibitions on manufacturing (including
import) and processing of TCE would follow a staggered schedule, due to
supply chain considerations. EPA proposes that the compliance dates for
the proposed prohibitions described in this unit, such that the
requirements would come into effect in 90 days (3 months) for
manufacturers and in 180 days (6 months) for processors, with different
timeframes related to specific conditions of use. Specifically, for
processing TCE as a reactant/intermediate, EPA is proposing that the
compliance dates for the proposed prohibitions described in this unit
would come into effect in 1.5 years for manufacturers and 2 years for
processors. There are additional exceptions from the prohibition for
the manufacturing and processing associated with certain processing and
industrial and commercial uses, including those described later in this
unit (for which EPA is proposing longer compliance timeframes,
including phaseouts (see Units V.A.1.b., d., and e.) or time-limited
exemptions under TSCA section 6(g) (see Unit V.A.3.b.)). The rationale
for longer timeframes for certain conditions of use is described in
Unit VI.A.1.
b. Prohibitions on Industrial and Commercial Use and Distribution in
Commerce of TCE
EPA is proposing to prohibit the industrial and commercial use of
TCE, based on the unreasonable risk to workers and ONUs driven by these
conditions of use (Ref. 2). As discussed in Units III.B.3. and VI.A.,
based on consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty relative to the feasibility of exposure reduction to
sufficiently address the unreasonable risk across the broad range of
work environments and activities represented by industrial and
commercial uses of TCE, and the irreversible health effects associated
with TCE exposures, EPA has determined that prohibition is the best way
to address the unreasonable risk. However, in consideration of the
challenges several sectors may encounter in adopting alternatives to
TCE, EPA is proposing longer compliance timeframes for certain uses
under this prohibition.
EPA is proposing compliance dates for the proposed prohibitions
that would come into effect for most industrial and commercial users
270 days after the publication date of the final rule. However, EPA is
proposing longer compliance timeframes under this prohibition for some
industrial and commercial uses and for the associated manufacturing
(including import), processing, and distribution in commerce.
Specifically, for two batch vapor degreasing conditions of use (open-
top and closed-loop), EPA is proposing that the compliance dates for
the proposed prohibitions described in this unit would come into effect
in 180 days for manufacturers, in 270 days (9 months) for processors,
specifically for processing into a formulation and for recycling, and
in 1 year for the industrial and commercial uses of TCE in open-top and
closed-loop batch vapor degreasers (see Unit III.B.1.c.i. and ii. for
descriptions of these conditions of use and Unit VI.A.1. for a
rationale for the slightly longer timeframe). For a sub-set of the
closed-loop batch vapor degreasing condition of use (industrial and
commercial use of TCE as a solvent for closed-loop batch vapor
degreasing for rayon fabric scouring for end use in rocket booster
nozzle production for Federal agencies and their contractors) EPA is
proposing that the compliance dates for the proposed prohibitions
described in this unit would come into effect in five or 10 years for
manufacturers, processors, distributors, and industrial and commercial
users, depending on whether the conditions of the phaseout are met (see
Unit V.A.1.e. for a description of the conditions of this proposed
exemption, and Unit VI.A.1. for the rationale for this timeframe).
Also, EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit would come into effect for
commercial use of TCE as a processing aid in 1.5 years for
manufacturers, in 2 years for processors, and in 2 years for industrial
and commercial use of TCE in: processing aid in process solvent used in
battery manufacture; process solvent used in polymer fiber spinning,
fluoroelastomer manufacture and Alcantara manufacture; extraction
solvent used in caprolactam manufacture; and precipitant used in beta-
cyclodextrin manufacture (see Unit III.B.1.c.xvi. for a description of
this condition of use and Unit V.A.1. for a rationale for the different
timeframe).
To aid with implementation of the compliance dates for the proposed
prohibitions on manufacturing, processing, and industrial and
commercial use of TCE, and ensure that those prohibitions effectively
address the unreasonable risk identified, EPA is also proposing
prohibitions on distribution in commerce of TCE. Generally, for most
conditions of use EPA is proposing that the compliance date for the
proposed prohibition on distributors in commerce of TCE would come into
effect 180 days (6 months) following publication of the final rule. In
instances where EPA is proposing a prohibition on manufacturing and
processing TCE for a particular industrial and commercial use that is
later than 180 days after publication of the final rule, the compliance
date for the proposed prohibition on distribution in commerce would be
the same as the compliance date of the proposed prohibition on
manufacturing and processing TCE.
As noted in Unit III.B.1.f., this proposal does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the
impacts, if any, that a prohibition on the processing of TCE into a
formulation, mixture or reaction product in other chemical products and
preparations, or other aspects of this proposal, may have on the
production and availability of any pesticide or other substance
excluded from the TSCA definition of ``chemical substance.'' EPA also
requests comment on whether it should consider a de minimis level of
TCE in formulations to account for impurities (e.g., 0.1% or 0.5%) when
finalizing the prohibitions described in this unit, and, if so,
information on and rationale for any level that should be considered de
minimis.
When proposing the compliance dates described in this unit as
required under TSCA section 6(d), EPA considered irreversible health
effects associated with TCE exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
However, EPA requests comment on whether additional time is needed, for
example, for products to clear the channels of trade, or for
implementing the use of substitutes; comments should include
documentation such as the specific use of the chemical throughout the
supply chain; concrete steps taken to identify, test, and qualify
substitutes for those uses (including details on the substitutes tested
and the specific
[[Page 74734]]
certifications that would require updating); and estimates of the time
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply. EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
c. Prohibitions of Manufacturing, Processing, and Distribution in
Commerce of TCE for Consumer Use
The consumer uses evaluated in the 2020 Risk Evaluation for TCE
constitute all known, intended, and reasonably foreseen consumer uses
of TCE. As described in this unit, EPA is proposing to prohibit all
manufacturing (including import) and processing of TCE to address the
unreasonable risk to workers and ONUs driven by those conditions of use
(Ref. 2). EPA does not believe any delays are necessary for
prohibitions on manufacture (including import), processing, or
distribution in commerce of TCE for consumer use. EPA notes that not
only did all but one of the 24 consumer uses of TCE evaluated in the
2020 Risk Evaluation for TCE support the unreasonable risk
determination for TCE (Refs. 1, 2), but also the manufacture (including
import) and processing of TCE for consumer uses generally supports
EPA's unreasonable risk determination for workers and ONUs, as further
discussed in Unit V.A. For these reasons, and based on considerations
of the severity of the hazards of TCE, EPA is proposing to prohibit the
manufacturing (including import), processing, and distribution in
commerce of TCE for all uses, which includes all consumer uses.
EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit relevant to consumer uses would
come into effect for manufacturers 90 days (3 months) and for
processors 180 days (6 months) after the publication date of the final
rule in the Federal Register. EPA is also proposing prohibitions on
distribution in commerce of TCE for consumer uses to aid with effective
implementation of the prohibitions on manufacturing and processing, and
to address the unreasonable risk to consumers and bystanders. EPA
proposes that the compliance dates for the proposed prohibition on
distribution in commerce of TCE for consumer use would come into effect
180 days (6 months) after the publication date of the rule in the
Federal Register. EPA considered the risk of irreversible health
effects associated with TCE exposure when proposing these compliance
dates. EPA has no reasonably available information indicating these
proposed compliance dates are not practicable for the activities that
would be prohibited or that additional time is needed for products to
clear the channels of trade. However, EPA requests comment on whether
additional time is needed, for example, for products to clear the
channels of trade, or for implementing the use of substitutes; comments
should include the considerations described in Unit V.A.1.b. EPA may
finalize significantly shorter or longer compliance timeframes based on
consideration of public comments.
EPA also requests comment on whether it should consider a de
minimis level of TCE in formulations to account for impurities (e.g.,
0.1% or 0.5%) when finalizing the prohibitions described in this unit,
and, if so, information on and rationale for any level that should be
considered de minimis.
d. Phaseout of TCE for Processing as an Intermediate for the
Manufacture of HFC-134a.
As described in this unit, EPA is proposing a longer phaseout
timeframe for the manufacturing (including import) and processing of
TCE as an intermediate for the manufacture of HFC-134a (1,1,1,2-
Tetrafluroethane; CAS Number 811-97-2). EPA is proposing an 8.5-year
phaseout subject to the requirements discussed in this unit. All other
processing of TCE as a reactant/intermediate would be subject to the
proposed prohibitions described in Unit V.A.1.b. EPA is proposing to
require a phaseout for processing of TCE as an intermediate for the
manufacture of HFC-134a, which EPA expects would begin at the final
rule's effective date and end 8.5 years after the publication of the
final rule. Associated with this phaseout, EPA would require the
establishment of the TCE WCPP, outlined in Unit V.A.2., within 6 months
after publication of the final rule, as workplace protections during
the period of the phaseout. To set the phaseout volumes, EPA would
require any facility processing TCE as an intermediate to manufacture
HFC-134a in the United States to establish a baseline of the annual
quantity of TCE processed by the facility as a feedstock to manufacture
HFC-134a. EPA is proposing to require that within 6 months after the
publication of the final rule the manufacturer could use the average of
any 12 consecutive months in the 36 months preceding the publication of
the final rule to calculate their baseline, based on records that
demonstrate how the baseline annual volume was calculated. Following
the establishment of a baseline volume, the regulated entity would then
be required to implement a 4-step phaseout process; specifically, the
phaseout would be a 25 percent reduction from the baseline volume every
2 years as follows: (1) 2.5 years after the publication of the final
rule each manufacturer of HFC-134a who processes TCE as an intermediate
would not be permitted to process TCE as an intermediate at an annual
volume greater than 75 percent of the baseline; (2) 4.5 years after the
publication of the final rule each manufacturer of HFC-134a who
processes TCE as an intermediate would not be permitted to process TCE
as an intermediate at an annual volume greater than 50 percent of the
baseline; (3) 6.5 years after the publication of the final rule each
manufacturer of HFC-134a who processes TCE as an intermediate would not
be permitted to process TCE as an intermediate at an annual volume
greater than 25 percent of the baseline; and (4) 8.5 years after the
publication of the final rule each manufacturer of HFC-134a would be
prohibited from processing TCE as an intermediate.
EPA notes that the prohibition for manufacture (including
importing), processing, and distribution in commerce of TCE for this
condition of use would occur after 8.5 years to account for
availability of TCE through the supply chain during the period of the
phaseout of processing of TCE as an intermediate for the manufacture of
HFC-134a. This timeframe would be longer than the prohibitions on
manufacturing and processing TCE described in Unit V.A.1.a.
EPA is also proposing to require regulated entities to keep records
of the annual quantity of TCE purchased and processed from the year
2023 until the termination of all processing of TCE as an intermediate.
EPA requests comment on whether additional recordkeeping requirements
are warranted or additional time would be needed, for example, to begin
the phaseout of processing TCE as an intermediate for the manufacture
of HFC-134a.
EPA notes, per TSCA section 6(c)(2)(C), that although the use of
TCE to produce HFC-134a would be prohibited eventually due to
unreasonable risk, the use of PCE to produce HFC-134a is proposed to
continue in perpetuity under a WCPP (88 FR 39652, July 16, 2023). As
such, the refrigerant would remain available while protecting workers.
[[Page 74735]]
e. Phaseout of TCE in industrial and Commercial Use as a Solvent for
Closed-Loop Batch Vapor Degreasing for Rayon Fabric Scouring for Rocket
Booster Nozzle Production
EPA is proposing a longer phaseout timeframe for industrial and
commercial use as a solvent for closed-loop batch vapor degreasing for
rayon fabric scouring for end use in rocket booster nozzle production
by Federal agencies and their contractors. This is the industrial and
commercial use of TCE in a closed-loop batch vapor degreaser to clean,
or `scour,' rayon fabric to remove sizing (i.e., protective filler or
glaze on textiles), oils, and other contaminants from the rayon fabric
that is used to line the inside of rocket booster nozzles; the
degreasing is essential in preparing the rayon fabric before a
carbonization process ahead of being used in the rocket booster
nozzles. If contaminants are not removed properly from the rayon, the
result could include nozzle failure (Ref. 43). More information on this
use and the rationale for the phaseout are in Unit VI.A.1. For this
sub-set of the vapor degreasing condition of use, when conducted by
Federal agencies and their contractors, EPA is proposing a 10-year
phaseout subject to the requirements discussed in this unit. (All other
industrial and commercial use of TCE as a solvent for vapor degreasing,
including use of TCE in closed-loop batch vapor degreasing of other
parts or materials, would be subject to the proposed prohibitions
described in Unit V.A.1.b.). For the phaseout, EPA is proposing that
within 5 years of the publication date of the final rule the Federal
agency that is the end user of the rayon fabric for rocket booster
nozzle production (e.g., the U.S. Department of Defense (DOD) or the
NASA) would need to conduct a final pre-launch test of rocket boosters
without using TCE; this test is further discussed in Unit VI.A.1.a. By
10 years from the publication date of the final rule, the phaseout
would be complete and industrial and commercial use of TCE as a solvent
for closed-loop batch vapor degreasing, including for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, would be prohibited. As part of this
phaseout, EPA would require a TCE WCPP, described in Unit V.A.2.,
within 6 months after publication of the final rule, as workplace
protections during the period of the phaseout until the full
prohibition takes effect. Additionally, this phaseout would include
recordkeeping requirements beginning 6 months after publication of the
final rule related to the rayon fabric scouring for end use in rocket
booster nozzle production. The entity must have records indicating that
their closed-loop batch vapor degreasing with TCE is for rayon fabric
scouring for end use in rocket booster nozzle production for a Federal
agency or a contractor. Beginning 5 years after the publication of the
final rule, to continue to use TCE for closed-loop batch vapor
degreasing for this specific use, the user must have records from a
Federal agency indicating that a final pre-launch test for the rayon
fabric scouring has been conducted with an alternative chemical or
process.
f. Prohibition of Disposal of TCE to Industrial Pre-Treatment,
Industrial Treatment, or Publicly Owned Treatment Works
Due to the unreasonable risk to workers exposed to TCE while
performing industrial wastewater pre-treatment and treatment, EPA is
proposing to prohibit this mode of disposal of TCE (i.e., generated
wastewater that contains TCE that is collected on site or transported
to a third party site, and includes the mixing of TCE with wastewater
and the discharge of TCE-contaminated wastewater) (description of
disposal for the purposes of this rulemaking is in Unit III.B.2.d.).
TSCA section 6(a) provides EPA the authority to prohibit or otherwise
regulate any manner or method of disposal of a chemical substance by
its manufacturer, processor, or any other person who uses or disposes
of it for commercial purposes. EPA is proposing to prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works. Facilities generating solid waste with
TCE concentrations above the RCRA regulatory level of 0.5 mg/L using
the Toxicity Characteristic Leaching Procedure (see 40 CFR 261.24)
would need to manage TCE separately from wastewater and dispose of TCE
through a different disposal mechanism, due to the prohibition in RCRA
against using dilution as a substitute for appropriate treatment (see
40 CFR 268.3), while following the appropriate RCRA requirements when
handling waste containing TCE. Dilution of hazardous waste (including
by mixing it with wastewater) as a substitution for adequate treatment
is prohibited under RCRA (see 40 CFR 268.3).
EPA is proposing that the compliance date for the proposed
prohibition described in this unit would be 270 days (9 months) after
the publication date of the final rule for manufacturers, processors,
distributors, and industrial and commercial users disposing of TCE to
wastewater. EPA has no information indicating that the proposed
compliance dates would not be practicable for purposes of finding an
alternative disposal method, or that additional time would be needed,
for example, for facilities to transition to an alternative disposal
method. EPA's understanding is that only 1 percent of TCE is disposed
of as wastewater. However, EPA requests comment on whether the 270-day
proposed compliance date is practicable, whether additional time is
needed, for example, for a regulated entity to implement a change to
their disposal processes or to transition to alternative disposal
methods, including what those alternative disposal methods would be,
and their cost and feasibility. EPA is also proposing, as described in
Unit V.A.3., a time-limited exemption for 50 years under TSCA section
6(g) for disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purpose of cleanup
projects of TCE-contaminated groundwater and other wastewater.
2. WCPP for Certain Conditions of Use
a. Overview
As described in Unit III.B.3., EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. The TSCA section 6(a) requirements provide EPA the authority
to limit or restrict a number of activities, alone or in combination,
including the manufacture, processing, distribution in commerce,
commercial use, and disposal of the chemical substance. Given this
authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational conditions
of use (e.g., manufacturing, processing, industrial and commercial
use). However, for the reasons described in Unit VI., including the
challenges of reliably reducing exposure below the ECEL and being able
to monitor at the appropriate action level, EPA's proposed requirement
for the TCE WCPP is that owners or operators ensure that no person is
exposed to TCE in excess of the ECEL as an 8-hr TWA to the extent
possible (supported by documentation further described in Unit
V.A.2.d.i.) rather than (as has been proposed in other rules under TSCA
section 6) a requirement that exposures do not exceed the ECEL. Due to
these
[[Page 74736]]
challenges, as well as the severity of the hazard from TCE, EPA notes
that long-term implementation of the WCPP would not be a feasible means
of addressing TCE unreasonable risk and thus EPA believes that
prohibition of the COUs would ultimately be necessary to address the
unreasonable risk. Furthermore, when selecting among proposed
prohibitions and other restrictions that would apply to those
occupational conditions of use, EPA has also factored in considerations
relating to health effects on PESS, including on older pregnant workers
and ONUs (the group identified as most susceptible to fetal cardiac
defects), further discussed in Units V.A.1. and VI.A. For the time
period before which a prohibition would become effective, for several
conditions of use, EPA is proposing a TCE WCPP to address to the extent
possible the unreasonable risk. The WCPP would include a TCE ECEL of
0.0011 ppm, the associated implementation requirements, and may include
other components, such as dermal protection, as described in this unit.
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, ONUs, employees, independent
contractors, employers, and all other persons in the work area who may
be exposed to TCE under the conditions of use for which a WCPP would
apply. EPA's intention is to require a comprehensive WCPP that would
put additional protections in place to reduce the unreasonable risk
from TCE to potentially exposed persons directly handling the chemical
or in the area where the chemical is being used, until the prohibition
compliance date.
Similarly, the risk evaluation for TCE did not distinguish between
employers, contractors, or other legal entities or businesses that
manufacture, process, distribute in commerce, use, or dispose of TCE.
EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use is occurring and TCE is present. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace.
An ECEL is a risk-based inhalation exposure threshold. The ECEL
would be accompanied by monitoring, training, recordkeeping, and other
requirements so that exposures to TCE are reduced to the extent
possible (as supported by documentation further described in Unit
V.A.2.d.i.). With an ECEL, the WCPP provides the least uncertainty
regarding the protection afforded to workers, requires regulated
entities to consider more protective controls in the hierarchy, and
lessens the burden on workers. Under this proposal, regulated entities
would have some flexibility in the manner in which they implement
modifications, within certain parameters outlined in this unit, or
otherwise aim to prevent exceedances of the ECEL at their facilities.
Therefore, EPA generally refers to the ECEL and ancillary requirements
as a non-prescriptive approach. This unit includes a summary of the
proposed TCE WCPP, including a description of the proposed ECEL of
0.0011 ppm; proposed implementation requirements and an EPA ECEL action
level; proposed monitoring requirements; a description of potential
exposure controls, which consider the hierarchy of controls;
information that may be used to inform respirator selection; proposed
glove requirements; and additional requirements proposed for
recordkeeping, and worker training, participation, and notification.
This unit also describes proposed compliance timeframes for these
proposed requirements.
EPA does not believe that long-term implementation of the WCPP
would be a feasible means of addressing unreasonable risk indefinitely;
thus prohibition of the use of TCE for affected COUs is ultimately
necessary to address the risk so that it is no longer unreasonable, due
to the severity of the hazard, the magnitude of the exposures, and the
challenges of consistently reducing exposures below the low TCE ECEL in
a way that is consistent with the hierarchy of controls, further
described in Unit VI.A.1. However, for the conditions of use which
would continue for longer than a year, as well as during the proposed
TSCA section 6(g) time-limited exemption, EPA is proposing the WCPP to
reduce to the extent possible the unreasonable risk from TCE during the
time period before compliance dates for the proposed prohibition would
come into effect. EPA is not proposing the WCPP for uses that would be
prohibited within 1 year from the effective date of the final rule.
Based on reasonably available information, EPA expects that the ECEL is
likely to be exceeded and that compliance with the WCPP would require
large investments into PPE and engineering controls at facilities. For
this reason, EPA's proposal aims to encourage facilities engaged in
uses that would be prohibited within a year from finalization to focus
their resources on the transition to alternatives to TCE. EPA is
requesting comment on how entities could demonstrate that they are
reducing exposures to the extent possible (including considerations for
technological feasibility) and is also requesting comment on whether
EPA's requirement should be that entities ensure that exposures are
reduced below the ECEL, rather than to the extent possible or lowest
achievable level described further in Unit V.A.2.d.i. Should regulated
entities be able to consistently demonstrate compliance with an ECEL
through effective controls, EPA requests comments regarding replacing
the proposed prohibitions with compliance with the WCPP.
b. Existing Chemical Exposure Limit (ECEL)
i. ECEL and ECEL Action Level
To reduce exposures in the workplace and eliminate the unreasonable
risk of injury to health resulting from inhalation exposures to TCE
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for TCE, EPA is proposing an ECEL of 0.0011 parts per
million (ppm) (0.0059 mg/m\3\) for inhalation exposures to TCE as an 8-
hour TWA. As described in Unit IV.A., this ECEL is based on
developmental toxicity, the most sensitive acute and chronic non-cancer
health endpoint, specifically calculated based on the occupational
acute, non-cancer human equivalent concentration (HEC) for fetal
cardiac defects (Ref. 13). EPA is proposing to establish requirements
for an ECEL as part of the WCPP until the prohibition compliance date
for certain conditions of use that would be permitted to continue for
longer than a year after the effective date of the final rule,
including the conditions of use described in Unit V.A.1.a., as well as
the conditions of use that would be subject to the phaseout described
in Unit V.A.1.d. and the TSCA section 6(g) exemptions described in Unit
V.A.3.
Each owner or operator of a workplace where these conditions of use
occur would be responsible for compliance with the ECEL and the
associated requirements. EPA's description for how the requirements
related to an ECEL would reduce the unreasonable risk resulting from
inhalation exposures and the rationale for this regulatory approach is
outlined in Units III.B.3. and V.A.
In order for this rulemaking to appropriately reduce risk to all
potentially exposed persons that may be exposed to TCE through the
occupational conditions of use for which EPA is proposing compliance
with the WCPP as a protection measure,
[[Page 74737]]
EPA has factored in consideration of additional health effects
applicable to PESS pursuant to TSCA section 6(c)(2), outlined in Unit
VI.A. EPA developed the ECEL for the most sensitive health endpoint
(fetal cardiac defects) in support of risk management efforts on TCE
under TSCA, to identify at what level ambient exposures would protect
against unreasonable risk of injury to health due to fetal cardiac
defects. The level identified is an 8-hour ECEL of 0.0011 ppm, which,
when possible to achieve, is the concentration at which an adult human
would be unlikely to experience the specified adverse effects if
exposed during a working lifetime, including susceptible
subpopulations. In addition, at the acute non-cancer ECEL of 0.0011
ppm, any potentially exposed person in the workplace would be protected
against other non-cancer effects resulting from occupational exposures,
as well as excess risk of cancer (Ref. 13). However, as noted in Unit
IV., EPA does not believe that long-term implementation of the WCPP
with this low ECEL would be a feasible means of addressing unreasonable
risk indefinitely, and EPA is uncertain if the ECEL and associated
action level can be met reliably as discussed further in Unit VI.A.1.
EPA invites comment on the existing practices (e.g., engineering
controls, administrative controls, PPE) involving TCE for the
conditions of use listed in Unit V.A.1.a., Unit V.A.1.d., and Unit
V.A.3., whether activities may take place in closed systems, and the
degree to which users of TCE in these sectors could successfully
implement the WCPP, including an ECEL of 0.0011 ppm for TCE, dermal
protection, and ancillary requirements described in Unit IV.A. EPA
acknowledges that reducing and accurately detecting exposures from the
current OSHA PEL of 100 ppm to the proposed TSCA ECEL of 0.0011 ppm
would be very difficult. EPA also invites comment on the potential to
develop future technologies (e.g., engineering controls, administrative
controls, PPE) involving TCE for the conditions of use listed in Unit
V.A.1.a., Unit V.A.1.d., and Unit V.A.3., that would facilitate
successful implementation of the WCPP, including an ECEL of 0.0011 ppm
for TCE, dermal protection, and ancillary requirements described in
Unit IV.A. EPA is also requesting comment on the feasibility of
controlling worker exposures to TCE at or below the proposed ECEL, and
the accuracy of measurements at this level. This is important for
determining whether there are realistic and effective exposure controls
that can be used by industry for effectively controlling exposures to
levels at or below the ECEL. To the extent time is needed to ensure
methods are available to accurately measure TCE at or below the ECEL,
EPA is requesting comment on whether a phased approach to an ECEL is
desirable; that is, an approach that would establish a timeframe for
meeting the ECEL as well as a shorter timeframe for meeting a
concentration level higher than the ECEL (but lower than the PEL) that
is currently considered achievable. EPA welcomes data or information to
demonstrate that meeting the proposed ECEL over a sustained period of
time would be feasible and measurable.
EPA is also proposing to establish an ECEL action level of 0.00055
ppm as an 8-hour TWA for TCE. Air concentrations at or above the action
level would trigger more frequent periodic monitoring of exposures to
TCE, as described in this unit. EPA is proposing to adopt the action
level approach in implementing the TSCA ECEL, similar to the action
level approach used by OSHA in the implementation of OSHA standards,
although the values differ due to differing statutory authorities. As
explained by OSHA, due to the variable nature of employee exposures,
compliance with an action level provides employers with greater
assurance that their employees will not be exposed to concentrations
above the PELs (Ref. 44). EPA agrees with this reasoning and, like
OSHA, expects the inclusion of an ECEL action level will stimulate
innovation within industry to reduce exposures to levels below the
action level. Therefore, EPA has identified a need for an action level
for TCE and is proposing a level that would be half the 8-hour ECEL,
which is in alignment with the precedented approach established under
most OSHA standards. EPA is soliciting comment regarding an ECEL action
level that is half the ECEL and any associated provisions related to
the ECEL action level when the ECEL is significantly lower than the
OSHA PEL. EPA is also soliciting comment on whether the ECEL action
level should be aligned with OSHA PEL action levels (typically set at
half the limit) due to the fact that PEL accounts for technological
feasibility and the action level is not necessarily designed to be
health protective. Since exposure below the ECEL would be health
protective, EPA seeks comment on whether the action level should be set
at a different value closer to the ECEL that would trigger increased
monitoring to ensure that the ECEL is not exceeded, and whether
technological feasibility should be considered in setting the action
level.
In summary, EPA is proposing that each owner or operator of a
workplace subject to compliance with the TCE WCPP must ensure that no
person is exposed to an airborne concentration of TCE in excess of
0.0011 ppm (0.0059 mg/m3) as an 8-hour TWA (ECEL), with an action level
identified as 0.00055 ppm (0.0029 mg/m3) (ECEL action level) to the
extent possible, as supported by documentation further described in
Unit V.A.2.d.i.). For conditions of use for which the requirements to
comply with the WCPP are being proposed, EPA expects that measurement
of extremely low-ppm levels of TCE may present challenges to the
regulated community. During the development of the TCE ECEL, EPA
conducted a search to identify relevant NIOSH, OSHA, and EPA analytical
methods that may be used to monitor for the presence of TCE in indoor
air. While EPA identified analytical methods that may be used, based on
information from stakeholders, EPA also recognizes that it may be
difficult to operationalize routine use of these methods for detection
at the low levels needed for the TCE ECEL and ECEL action level.
Specifically, these methods may be challenging to use for personal
breathing zone monitoring to detect lower air concentration levels at
the ECEL and ECEL action level based on the developmental toxicity
endpoint for fetal cardiac defects (Ref. 13). However, EPA acknowledges
that in recent years commercial passive air sampling devices have
improved and may be available for use for personal air sampling at
extremely low-ppm levels of TCE (Ref. 45). EPA is requesting comment on
personal air sampling devices that are capable of detecting indoor air
TCE concentrations at or below the ECEL action level of 0.00055 ppm
(0.0029 mg/m3) with the requisite precision and accuracy.
EPA acknowledges that the challenge of suitable personal breathing
zone monitoring methods to detect TCE air concentration levels at the
ECEL of 0.0011 ppm and ECEL action level of 0.00055 ppm could cause
difficulty in determining whether a workplace is in compliance with the
ECEL. EPA is therefore requesting comment on whether to require
compliance with an interim exposure level based on the limit of
detection of established analytical methods. This interim level, unlike
the ECEL, would not necessarily eliminate unreasonable risk, but rather
reduce risk to an extent that corresponds to the air concentration that
current analytical methods can reliably measure to and would be the
exposure
[[Page 74738]]
limit during the period in which TCE is still in use until its eventual
prohibition. EPA requests comment on setting such an interim level for
TCE based on a limit of detection that is the lowest limit of detection
using analytical methods developed by OSHA/NIOSH for personal breathing
zone monitoring. More specifically, EPA requests comment on using OSHA
Method 1001, which has a personal breathing zone limit of detection for
TCE of 18 ppb, or 0.018 ppm, to set an interim exposure limit of 0.036
ppm, with an action level of 0.018 ppm (Ref. 46).
Under this approach, EPA would initially establish an exposure
value that would be technically feasible to detect in the near-term,
with a step down to the ECEL at a later date, until the applicable
prohibition would take effect. This approach would significantly reduce
exposures to TCE from the current OSHA PEL of 100 ppm by establishing
an interim exposure value of 0.036 ppm and action level of 0.018 ppm,
until advancements in technologies reliably support measurement at the
ECEL or below. EPA requests comments that provide supported
recommendations for one or more incremental exposure values and
associated timelines for achieving the incremental exposure levels and
the currently proposed ECEL of 0.0011 ppm, and comments that consider
and provide information on the needed advancements in exposure
monitoring methods, analytical methods, and exposure controls,
including expected timelines for developing these capabilities.
The proposed requirements would be applicable to owners and
operators of workplaces where manufacturing (including import),
processing, and industrial and commercial use of TCE would be permitted
to continue more than 1 year after the publication of the final rule.
The proposed requirements would be applicable from the date of
publication of the final rule until the prohibition compliance date for
those conditions of use. However, the proposed requirements of the WCPP
would not be applicable to owners and operators of workplaces where EPA
is proposing to prohibit manufacturing and processing for certain
industrial and commercial use and consumer uses within 1 year of the
effective date of the final rule. The WCPP would also not be applicable
to owners and operators of workplaces where EPA is proposing to
prohibit distribution in commerce or disposal to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
As described further in Unit VI.A.1., EPA believes that long-term
implementation of the WCPP for continued use of TCE is not a feasible
means of addressing unreasonable risk such that prohibition ultimately
would be necessary to address the unreasonable risk.
ii. Monitoring Requirements
Overview. Monitoring requirements are a key component of
implementing EPA's proposed WCPP. Initial monitoring for TCE would be
critical for establishing a baseline of exposure for potentially
exposed persons and for identifying the lowest achievable exposure
level in a facility; similarly, periodic exposure monitoring would
assure that exposures continue to be reduced to the lowest level
achievable so that unreasonable risk of injury is reduced for
potentially exposed persons in the workplace. Periodic exposure
monitoring frequency could change if certain conditions are met, which
are described in this unit. Additionally, in some cases, a change in
workplace conditions with the potential to impact exposure levels would
warrant additional monitoring, which is also described. To ensure
compliance with monitoring activities, EPA proposes exposure monitoring
recordkeeping requirements outlined in this unit.
Initial exposure monitoring. Under the proposed regulation, each
owner or operator of a workplace where any condition of use subject to
a WCPP is occurring would be required to perform initial exposure
monitoring to determine the extent of exposure of potentially exposed
persons to TCE. Initial monitoring would notify owner or operators of
the magnitude of possible exposures, to their potentially exposed
persons with respect to their unique work conditions and environments.
The results of the initial exposure monitoring would be used to help
determine the lowest achievable level in a facility, the frequency of
future periodic monitoring, whether additional exposure controls are
necessary (such as engineering controls, administrative controls, and/
or respiratory protection), and whether the owner or operator would
need to demarcate a regulated area as described in this unit.
EPA is proposing to require each owner or operator to establish an
initial baseline monitoring sample to determine the magnitude of
exposure for all persons who may be exposed to TCE within 180 days (6
months) after the date of publication of the final rule in the Federal
Register. Where TCE is present in the workplace, each owner or operator
would be required to determine each potentially exposed person's
exposure by either taking a personal breathing zone air sample of each
potentially exposed person or taking personal breathing zone air
samples that are representative of each potentially exposed person's
exposure performing the same or substantially similar operations in
each work shift, in each job classification, and in each work area
(hereinafter identified as an ``exposure group''). Representative 8-
hour TWA exposures must be determined based on one or more samples
representing full-shift exposures for each shift for each person in
each job classification in each work area. Monitoring samples must be
taken when and where the operating conditions are best representative
of each potentially exposed person's full-shift exposures, and also
must represent the highest TCE exposures likely to occur under
reasonably foreseeable conditions of use. EPA expects that owners and
operators would attempt to monitor a baseline for all of the tasks
during the same timeframe; however, EPA understands that certain tasks
occur less frequently, and EPA is soliciting comments regarding the
timing of the initial exposure monitoring so that it would be
representative of all tasks involving TCE where exposures may approach
the ECEL. If the owner or operator chooses a representative sample,
such sampling must include persons that are the closest to the source
of TCE, so that the monitoring results are representative of the most
highly exposed persons in the workplace. EPA is also soliciting
comments regarding use of area source monitoring instead of personal
breathing zone as a representative sample of exposures.
EPA also recognizes that some entities may already have exposure
monitoring data. If the owner or operator has monitoring data conducted
within five years prior to the effective date of the final rule and the
monitoring would satisfy the monitoring requirements described in this
unit, including the requirement that the data represent the highest TCE
exposures likely to occur under reasonably foreseeable conditions of
use, the owner or operator may rely on such earlier monitoring results
for the initial baseline monitoring sample.
EPA proposes to require each owner or operator to perform exposure
monitoring to identify the lowest achievable exposure level in relation
to the ECEL value, and ensure to the extent possible (supported by
documentation further described in Unit V.A.2.d.i) that no person is
exposed to an airborne concentration of TCE in exceedance of
[[Page 74739]]
the ECEL. EPA requests comment on how owners and operators should
identify the lowest achievable exposure level, what documentation would
be needed to support that further reductions are not possible, and
whether EPA should provide a definition of meeting the ECEL to the
extent possible. Additionally, EPA requests comment on whether current
monitoring methods (Ref. 13) are able to detect airborne concentrations
at the ECEL and action level values. EPA expects that detection and
adherence to extremely low-ppm levels of TCE may present challenges to
some in the regulated community; therefore, EPA is also requesting
comment on whether EPA should propose specific requirements following
results indicating non-detectable concentrations of TCE (non-detects),
or a requirement that a specific monitoring method be used.
Periodic exposure monitoring. EPA is proposing to require each
owner or operator to conduct, for those exposure groups that exceed the
following airborne concentration levels, the following periodic
monitoring:
If all samples taken during the initial exposure
monitoring reveal a concentration below the ECEL action level (0.00055
ppm 8-hour TWA), the owner or operator must repeat the periodic
exposure monitoring at least once every five years.
If the initial or most recent exposure monitoring
indicates that airborne exposure is above the ECEL (0.0011 ppm 8-hour
TWA), the owner or operator must repeat the periodic exposure
monitoring within 3 months of the most recent exposure monitoring.
If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (0.00055 ppm 8-
hour TWA) but at or below the ECEL (0.0011 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within 6
months of the most recent exposure monitoring.
If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owners or operators must repeat such monitoring within 6 months of the
most recent monitoring until two consecutive monitoring measurements
taken at least seven days apart, are below the ECEL action level
(0.00055 ppm 8-hour TWA), at which time the owner or operator must
repeat the periodic exposure monitoring at least once every 5 years.
Additionally, in instances where an owner or operator does not
manufacture, process, distribute, or use TCE for a condition of use for
which the WCPP is proposed over the entirety of time since the last
required periodic monitoring event, EPA is proposing that the owner or
operator would be permitted to forgo the next periodic monitoring
event. However, documentation of cessation of use of TCE would be
required and periodic monitoring would be required to resume should the
owner or operator restart any of the conditions of use listed in Unit
V.A.2. for which the WCPP is proposed as a workplace protection
measure.
The proposed periodic monitoring requirements are also outlined in
Table 1. EPA requests comment on the timeframes for periodic monitoring
outlined in this unit. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments. EPA
requests comment on the ability for a facility to perform the proposed
periodic monitoring requirements, specifically whether monitoring
methods can detect the ECEL action level and ECEL value.
Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below the ECEL action level (<0.00055 required at least once every 5
ppm 8-hour TWA). years.
If the initial or most recent exposure Periodic exposure monitoring is
monitoring indicates that airborne required within 3 months of
exposure is above the ECEL (>0.0011 the most recent exposure
ppm 8-hour TWA). monitoring.
If the initial or most recent exposure Periodic exposure monitoring is
monitoring indicates that airborne required within 6 months of
exposure is at or above the ECEL the most recent exposure
action level but at or below the ECEL monitoring.
(>=0.55 ppb 8-hour TWA, <=0.0011 ppm 8-
hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within 5 years of the
taken at least seven days apart within most recent exposure
a 6-month period, indicate that monitoring.
airborne exposure is below the ECEL
action level (<0.00055 ppm 8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which compliance its current periodic
with the WCPP would be required but monitoring event. However,
does not manufacture, process, use, or documentation of cessation of
dispose of TCE in that condition of use of TCE as well as periodic
use over the entirety of time since monitoring would be required
the last required monitoring event. when the owner or operator
resumes or starts any of the
conditions of use for which
compliance with the WCPP is
proposed.
------------------------------------------------------------------------
Additional exposure monitoring. In addition to the initial and
periodic exposure monitoring, EPA is proposing that each owner or
operator conduct additional exposure monitoring whenever a change in
the production, process, control equipment, personnel, or work
practices that may reasonably be expected to result in new or
additional exposures at or above the ECEL action level, or when the
owner or operator has any reason to believe that new or additional
exposures at or above the ECEL action level have occurred. In the event
of start-up, shutdown, spills, leaks, ruptures or other breakdowns that
may lead to employee exposure, EPA is proposing that each owner or
operator must conduct additional initial exposure monitoring to
potentially exposed persons (using personal breathing zone sampling)
after the cleanup of the spill or repair of the leak, rupture or other
breakdown. An additional exposure monitoring event may result in an
increased frequency of periodic monitoring. For example, if the initial
monitoring results from a workplace are above the ECEL action level,
but below the ECEL, periodic monitoring is required every 6 months. If
additional monitoring is performed because increased exposures are
suspected, and the results are above the ECEL, subsequent periodic
monitoring would have to be performed every 3 months. The required
additional exposure monitoring should not delay implementation of any
necessary cleanup or other remedial action to reduce the exposures to
persons in the workplace.
[[Page 74740]]
Other monitoring requirements. For each monitoring event, EPA is
proposing to require owners or operators ensure that their methods be
accurate, to a confidence level of 95 percent, to within plus or minus
25 percent for airborne concentrations of TCE. Also, EPA is proposing
to require use of appropriate sampling and analytical methods used to
determine TCE exposure, including as relevant: (A) Use of an analytical
method already approved by EPA, OSHA or NIOSH, or another analytical
method that has been demonstrated to meet the proposed accuracy
requirement at an appropriate limit of detection for the ECEL and ECEL
action level; (B) Compliance with the Good Laboratory Practice
Standards at 40 CFR part 792. Additionally, EPA is proposing to require
owners and operators to re-monitor within 15 working days after receipt
of the results of any exposure monitoring when results indicate non-
detect or air monitoring equipment malfunction, unless an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist reviews the monitoring results and determines re-monitoring
is not necessary.
EPA is also proposing to require that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
(A) Dates, duration, and results of each sample taken;
(B) All measurements that may be necessary to determine the
conditions (e.g., work site temperatures, humidity, ventilation rates,
monitoring equipment type and calibration dates) that may affect the
monitoring results;
(C) Name, workplace address, work shift, job classification, and
work area of the person monitored; documentation of all potentially
exposed persons whose exposures the monitoring is intended to represent
if using a representative sample; and type of respiratory protective
device worn by the monitored person, if any;
(D) Use of appropriate sampling and analytical methods, such as
analytical methods already approved by EPA, OSHA or NIOSH, or
compliance with an analytical method verification procedure;
(E) Compliance with the Good Laboratory Practice Standards at 40
CFR part 792; and
(F) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
iii. Incorporation of the Hierarchy of Controls
EPA is proposing to require owners or operators to implement the
WCPP in accordance with the hierarchy of controls and encourages the
use of pollution prevention to control exposures whenever practicable.
Pollution prevention, also known as source reduction, is any practice
that reduces, eliminates, or prevents pollution at its source (e.g.,
elimination and substitution). Similarly, the hierarchy of controls
includes, in order of preference, elimination, substitution,
engineering controls, and administrative controls, prior to relying on
PPE as a means of controlling exposures (Ref. 12). EPA is proposing to
require owners or operators to reduce inhalation exposures below the
ECEL in accordance with the hierarchy of controls to the extent
possible as supported by documentation further described in Unit
V.A.2.d.i.). EPA expects that, for conditions of use for which EPA is
proposing a WCPP as a protection measure, compliance at most workplaces
would be part of an existing industrial hygiene program. Workplaces
would have to institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
reduce exposures to the extent feasible (Ref. 12). If an owner or
operator chooses to replace TCE with a substitute, EPA recommends that
they carefully review the available hazard and exposure information on
the potential substitutes to avoid a regrettable substitution.
If an effort to identify and implement feasible exposure controls,
in accordance with the hierarchy of controls, such as elimination,
substitution, engineering controls, and administrative controls is
found not to be sufficient to reduce exposures to or below the ECEL for
all persons in the workplace, EPA proposes to require each owner or
operator to use such controls to reduce TCE concentrations in the
workplace to the lowest levels achievable and, only after levels cannot
be further reduced, supplement these controls using respiratory
protection before persons are permitted to enter a regulated area, as
described in this unit. In such cases, EPA would require that the owner
or operator provide those persons exposed or who may be exposed to TCE
by inhalation above the ECEL with respirators so that exposures can be
reduced to the extent possible (supported by documentation further
described in Unit V.A.2.d.i.). EPA also proposes to require that each
owner or operator document their evaluation of elimination,
substitution, engineering and administrative exposure control
strategies and, if applicable, the reasons why they found these
strategies infeasible to control exposures below the ECEL, in an
exposure control plan as described in this unit. In addition, a
regulated entity would be prohibited from rotating work schedules of
potentially exposed persons to comply with the ECEL 8-hour TWA. EPA may
require more, less, or different documentation regarding exposure
control strategies in the final rule based on consideration of public
comments. The Agency understands that certain engineering controls can
reduce exposures to people inside the workplace but may lead to
increased ventilation of TCE outside of the workplace, thereby
potentially increasing risks of adverse health effects from exposures
to TCE in ambient air to people in fenceline communities. EPA expects
that processing and commercial use of TCE for the conditions of use for
which the WCPP would apply will decrease ahead of the prohibition
compliance dates (Ref. 3) and therefore expects that any risks to
fenceline communities would also decrease. More information on EPA's
analysis of ambient air and water pathways is in Unit VII.A. To
understand more fully the potential impacts to fenceline communities of
requirements to reduce workplace exposure to TCE, EPA is requesting
comment on whether industry anticipates increased releases of TCE to
outdoor air associated with the implementation of the WCPP. In order to
avoid unintended increases in exposures to people from TCE emissions to
ambient air, EPA requests comment on whether owners and operators
should be required to attest in their exposure control plan that
engineering controls selected do not increase emissions of TCE to
ambient air outside of the workplace and document in their exposure
control plan whether additional equipment was installed to capture
emissions of TCE to ambient air. EPA requests comment on how such a
requirement could impact the availability, feasibility, or cost of
engineering controls as a means to reduce workplace exposures to or
below the proposed ECEL.
iv. Regulated Area
Based on the exposure monitoring, EPA is proposing to require that
owners or operators of workplaces subject to a WCPP as a protection
measure demarcate any area where airborne concentrations of TCE exceed
or are reasonably expected to exceed the ECEL. Regulated areas would be
[[Page 74741]]
demarcated using administrative controls, such as warning signs or
highly visible signifiers, in multiple languages as appropriate (e.g.,
based on languages spoken by potentially exposed persons), placed in
conspicuous areas, and documented through training and recordkeeping.
The owner or operator would be required to restrict access to the
regulated area from anyone who is not an authorized user, which
includes any potentially exposed person that lacks proper training, is
not wearing required PPE as described in this unit or is otherwise
unauthorized to enter. EPA is proposing to require owners and operators
demarcate a regulated area, beginning 9 months after the date of
publication of the final rule, or within 3 months after receipt of any
exposure monitoring that indicates exposures exceeding the ECEL. EPA is
soliciting comment on requiring warning signs to demarcate regulated
areas, such as the requirements found in OSHA's General Industry
Standard for Beryllium (29 CFR 1910.1024(m)(2)). EPA is also requesting
comment on whether the owner or operator should be required to permit
designated representatives of employees and other workers to enter
regulated areas to observe exposure monitoring similar to typical OSHA
Standard requirements, e.g., 29 CFR 1910.1024(d)(7).
v. Notification of Monitoring Results
EPA proposes that the owner or operator must, within 15 working
days after receipt of the results of any exposure monitoring, notify
each person whose exposure is represented by that monitoring in
writing, either individually to each potentially exposed person or by
posting the information in an appropriate and accessible location, such
as public spaces or common areas, outside the regulated area. This
notice must include the exposure monitoring results, identification and
explanation of the ECEL and ECEL action level in plain language,
identification of the lowest achievable exposure level, if applicable,
any corresponding required respiratory protection, if applicable, the
quantity, location, manner of TCE use and identified releases of TCE
that could result in exposure to TCE, and whether the airborne
concentration of TCE exceeds the ECEL. The notice must also include a
description of actions taken by the owner or operator to reduce
inhalation exposures to or below the ECEL, if applicable, or refer to a
document available to the potentially exposed persons which states the
actions to be taken to reduce exposures. The notice would be required
to be posted in multiple languages if necessary (e.g., notice must be
in a language that the potentially exposed person understands,
including a non-English language version representing the language of
the largest group of workers who cannot readily comprehend or read
English).
c. Personal Protective Equipment (PPE) Program
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL for all potentially exposed persons,
EPA is proposing to require implementation of a PPE program in
alignment with OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132. Consistent with 29 CFR 1910.132, owners
and operators would be required to provide PPE, including respiratory
protection and dermal protection selected in accordance with the
guidelines described in this unit, that is of safe design and
construction for the work to be performed. EPA is proposing to require
owners and operators ensure each potentially exposed person who is
required by this unit to wear PPE to use and maintain PPE in a
sanitary, reliable, and undamaged condition. Owners and operators would
be required to select and provide PPE that properly fits each
potentially exposed person who is required by this unit to use PPE and
communicate PPE selections to each affected person.
As part of the PPE program, EPA is also proposing that owners and
operators must comply with OSHA's general PPE training requirements at
29 CFR 1910.132(f) for application of a PPE training program, including
providing training on proper use of PPE (e.g., when and where PPE is
necessary, proper application, wear, and removal of PPE, maintenance,
useful life, and disposal of PPE). EPA is proposing that owners and
operators would provide PPE training to each potentially exposed person
who is required by this unit to wear PPE prior to or at the time of
initial assignment to a job involving potential exposure to TCE. Owners
and operators would also have to re-train each affected person at least
once annually or whenever the owner or operator has reason to believe
that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in the PPE to be used render the previous training
obsolete.
This unit includes a description of the PPE Program, including
proposed PPE as it relates to respiratory protection, proposed PPE as
it relates to dermal protection, and other proposed requirements such
as additional training for respirators and recordkeeping to support
implementation of a PPE program.
i. Respiratory Protection
Where elimination, substitution, engineering and administrative
controls are not feasible to reduce the air concentration to or below
the ECEL, EPA proposes to set minimum respiratory PPE requirements
based on an entity's most recent measured air concentration and the
level of PPE that EPA determined would be needed to reduce exposure to
the ECEL. In those circumstances, EPA is proposing to require a
respiratory protection PPE program with worksite-specific procedures
and elements for required respirator use. The respiratory protection
PPE program proposed by EPA would be based on the most recent exposure
monitoring concentration measured as an 8-hour TWA and would be
administered by a suitably trained program administrator. EPA is also
proposing to require each owner or operator select respiratory
protection in accordance with the guidelines described in this unit and
29 CFR 1910.134(a) through (l), except (d)(1)(iii), for proper
respirator use, maintenance, fit-testing, medical evaluation, and
training. EPA is not proposing to cross reference 29 CFR
1910.134(d)(1)(iii) because the WCPP contains requirements for
identifying TCE respiratory hazards in the workplace.
Required Respiratory Protection. EPA is proposing to require each
owner or operator supply a respirator, selected in accordance with this
unit, to each person who enters a regulated area within 3 months after
the receipt of any exposure monitoring that indicates exposures
exceeding the ECEL and thereafter must ensure that all persons within
the regulated area are using the provided respirators whenever TCE
exposures exceed or can reasonably be expected to exceed the ECEL.
Given the risks associated with TCE exposure above the ECEL, prompt
compliance with the respiratory protection requirements is important,
but EPA expects that most owners or operators will need some time after
the exposure monitoring results are received to acquire the correct
respirators and establish a respiratory protection program, including
training, fit-testing, and medical evaluations. While EPA believes that
3 months should be sufficient for this purpose, EPA is seeking comment
on whether this timeframe should be shorter (e.g.,
[[Page 74742]]
within two weeks after the receipt of any exposure monitoring that
indicates exposure exceeding the ECEL), given the severity of the
effect. EPA is also proposing that owners or operators who would be
required to administer a respiratory protection program must supply a
respirator selected in accordance with 29 CFR 1910.134(d)(1) (except
(d)(1)(iii)). Additionally, EPA is proposing that the owner or operator
must ensure that all filters, cartridges, and canisters used in the
workplace are labeled and color coded with the NIOSH approval label and
that the label is not removed and remains legible. 29 CFR
1910.134(d)(3)(iii), which EPA is proposing to cross-reference,
requires either the use of respirators with an end-of-life service
indicator certified by NIOSH for the contaminant, in this case TCE, or
implementation of a change schedule for canisters and cartridges that
ensures that they are changed before the end of their service life. EPA
is requesting comment on whether there should be a requirement to
replace cartridges or canisters after a certain number of hours, such
as the requirements found in OSHA's General Industry Standard for 1,3-
Butadiene (29 CFR 1910.1051(h)), or a requirement for a minimum service
life of non-powered air-purifying respirators such as the requirements
found in OSHA's General Industry Standard for Benzene (29 CFR
1910.1028(g)(3)(D)).
EPA is proposing the following requirements for respiratory
protection, based on the exposure monitoring concentrations measured as
an 8-hour TWA that exceed the ECEL (0.0011 ppm). EPA is proposing to
establish minimum respiratory protection requirements, such that any
respirator affording a higher degree of protection than the following
proposed requirements may be used. This unit includes respirator
selection requirements for respirators of assigned protection factors
(APFs) of 1,000 or greater.
If the measured exposure concentration is at or below
0.0011 ppm (1.1 ppb): no respiratory protection is required.
If the measured exposure concentration is above 0.0011 ppm
(1.1 ppb) and less than or equal to 0.0055 ppm (5.5 ppb) (5 times
ECEL): Any NIOSH-certified air-purifying quarter mask respirator (APF
5).
If the measured exposure concentration is above 0. 0055
ppm (5.5 ppb) and less than or equal to 0.011 ppm (11.0 ppb) (10 times
ECEL): Any NIOSH-certified air-purifying half mask or full facepiece
respirator equipped with NIOSH-approved organic vapor cartridges or
canisters; or any negative pressure (demand mode) supplied air
respirator equipped with a half mask (APF 10).
If the measured exposure concentration is above 0.0011 ppm
(1.1 ppb) and less than or equal to 0.0275 ppm (27.5 ppb) (25 times
ECEL): Any NIOSH-certified air-purifying full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters; any
NIOSH-certified powered air-purifying respirator equipped with NIOSH-
approved organic vapor cartridges; or any NIOSH-certified continuous
flow supplied air respirator equipped with a hood or helmet (APF 25).
If the measured exposure concentration is above 0.0275 ppm
(27.5 ppb and less than or equal to 0.055 ppm (55.0 ppb) (50 times
ECEL): Any NIOSH-certified air-purifying full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters; any
NIOSH-certified powered air-purifying respirator equipped with a tight-
fitting half facepiece and NIOSH-approved organic vapor cartridges or
canisters; any NIOSH-certified negative pressure (demand mode)
supplied-air respirator equipped with a full facepiece; any NIOSH-
certified continuous flow supplied-air respirator equipped with a
tight-fitting half facepiece; any NIOSH-certified pressure-demand or
other positive pressure mode supplied-air respirator equipped with a
tight-fitting half facepiece; or any NIOSH-certified negative pressure
(demand mode) self-contained breathing apparatus respirator equipped
with a full facepiece (APF 50).
If the measured exposure concentration is above 0.055 ppm
(55.0 ppb) and less than or equal to 1.1 ppm (1,100 ppb) (1,000 times
ECEL): Any NIOSH-certified powered air-purifying respirator equipped
with a full facepiece and NIOSH-approved organic vapor cartridges or
canisters; or any NIOSH-certified supplied air respirator equipped with
a full facepiece and operated in a continuous flow mode or pressure
demand or other positive pressure mode (APF 1,000).
If the measured exposure concentration is greater than 1.1
ppm (1,100 ppb) (1,000 times ECEL) or the concentration is unknown: Any
NIOSH-certified self-contained breathing apparatus (SCBA) equipped with
a full facepiece and operated in a pressure demand or other positive
pressure mode; or any NIOSH-certified supplied air respirator equipped
with a full facepiece and operated in a pressure demand or other
positive pressure mode in combination with an auxiliary SCBA operated
in a pressure demand or other positive pressure mode (APF 10,000).
EPA proposes to require that owners and operators document
respiratory protection used and PPE program implementation. EPA
proposes to require that owners and operators document in the exposure
control plan or other documentation of the facility's safety and health
program information relevant to respiratory program, including records
on the name, workplace address, work shift, job classification, work
area, and type of respirator worn (if any) by each potentially exposed
person, maintenance, and fit-testing, as described in 29 CFR
1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29
CFR 1910.134(k).
ii. Dermal Protection
EPA is proposing to require use and provision of chemically
resistant gloves by potentially exposed persons in combination with
specific activity training (e.g., glove selection (type, material),
expected duration of glove effectiveness, actions to take when glove
integrity is compromised, storage requirements, procedure for glove
removal and disposal, chemical hazards) for tasks where dermal exposure
can be expected to occur. EPA is proposing that owners and operators
must also consider other glove factors, such as compatibility of
multiple chemicals used simultaneously while wearing TCE-resistant
gloves or with glove liners, permeation, degree of dexterity required
to perform a task, and temperature, as identified in the Hand
Protection section of OSHA's Personal Protection Equipment Guidance
(Ref. 47), when selecting appropriate PPE. Furthermore, owners and
operators can select gloves that have been tested in accordance with
the American Society for Testing Material (ASTM) F739 ``Standard Test
Method for Permeation of Liquids and Gases through Protective Clothing
Materials under Conditions of Continuous Contact.'' EPA requests
comment on the degree to which additional guidance related to use of
gloves might be necessary. Additionally, EPA requests comment on
whether EPA should incorporate additional dermal protection
requirements into the exposure control plan or require consideration of
the hierarchy of controls for dermal exposures.
d. General WCPP Requirements
i. Exposure Control Plan
EPA proposes to require that owners and operators document their
exposure control strategy and implementation in
[[Page 74743]]
an exposure control plan or through adding EPA-required information to
any existing documentation of the facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards. EPA proposes to require that each owner or operator
document in the exposure control plan the following:
(A) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of TCE, substitution of
TCE, engineering controls, and administrative controls to reduce
exposures in the workplace to either at or below the ECEL or to the
lowest level achievable for TCE in the workplace;
(B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(D) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(E) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL or
lowest achievable exposure level;
(F) Identification of the lowest achievable exposure level and why
further reductions are not possible;
(G) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(H) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or lowest achievable exposure level and subsequent corrective
actions taken during start-up, shutdown, or malfunctions to mitigate
exposures to TCE; and
(I) Availability of the exposure control plan and associated
records for potentially exposed persons.
ii. Workplace Information and Training
EPA is also proposing to require implementation of a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with TCE
exposure, EPA is proposing to require that owners or operators of
workplaces subject to the WCPP institute a training and information
program for potentially exposed persons and assure their participation
in the training and information program.
As part of the training and information program, the owner or
operator would be required to provide information and comprehensive
training in an understandable manner (i.e., plain language) and in
multiple language as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons prior to or
at the time of initial assignment to a job involving potential exposure
to TCE. In alignment with the OSHA Hazard Communication Standard,
owners and operators would be required to provide information and
training to all potentially exposed persons that includes (A) the
requirements of the TCE WCPP and how to access or obtain a copy of the
requirements of the WCPP; (B) the quantity, location, manner of use,
release, and storage of TCE and the specific operations in the
workplace that could result in TCE exposure; (C) principles of safe use
and handling of TCE in the workplace, including specific measures the
owner or operator has implemented to reduce inhalation exposures or
prevent dermal contact with TCE, such as work practices and PPE used;
(D) the methods and observations that may be used to detect the
presence or release of TCE in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of TCE when being released, etc.); and (E)
the health hazards associated with exposure to TCE.
In addition to providing training at the time of initial assignment
to a job involving potential exposure to TCE, and in alignment with the
OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners
and operators subject to the TCE WCPP would be required to re-train
each potentially exposed person annually to ensure they understand the
principles of safe use and handling of TCE in the workplace. Owners and
operators would also need to update the training as necessary whenever
there are changes in the workplace, such as new tasks or modifications
of tasks, in particular, whenever there are changes in the workplace
that increase exposure to TCE or where potentially exposed persons'
exposure to TCE can reasonably be expected to exceed the action level.
To support compliance, EPA is proposing that each owner or operator of
a workplace subject to the WCPP would be required to provide to the
EPA, upon request, all available materials related to workplace
information and training.
iii. Workplace Participation
EPA encourages owners or operators to consult with persons that
have potential for exposure on the development and implementation of
exposure control plans and PPE/respirator programs. EPA is proposing to
require owners or operators to provide potentially exposed persons or
their designated representatives regular access to the exposure control
plans, exposure monitoring records, and PPE program implementation and
documentation. To ensure compliance in workplace participation, EPA is
proposing that the owner or operator document the notice to and ability
of any potentially exposed person that may reasonably be affected by
TCE inhalation exposure or dermal contact with TCE to readily access
the exposure control plans, facility exposure monitoring records, PPE
program implementation, or any other information relevant to TCE
inhalation or dermal exposure in the workplace. EPA is requesting
comment on how owners and operators can engage with potentially exposed
persons on the development and implementation of an exposure control
plan and PPE program.
iv. Recordkeeping
To support and demonstrate compliance, EPA is proposing that each
owner or operator of a workplace subject to WCPP retain compliance
records for five years. EPA is proposing to require records to include:
(A) the exposure control plan;
(B) PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
(C) information and training provided to each person prior to or at
the time of initial assignment and any re-training.
In addition, EPA is proposing that owners and operators subject to
the WCPP requirements maintain records to include:
(D) The exposure monitoring records;
(E) Notification of exposure monitoring results; and
(F) To the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the proposed WCPP requirements.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as
[[Page 74744]]
described in this unit available to EPA for examination and copying in
accordance with EPA requirements. All records required to be maintained
by this unit could be kept in the most administratively convenient form
(electronic or paper).
v. Compliance Timeframes
EPA is proposing to require each owner or operator of a workplace
subject to an ECEL conduct initial baseline monitoring according to the
process outlined in this unit by 6 months after date of publication of
the final rule in the Federal Register. EPA is proposing to require
each owner or operator ensure that the airborne concentration of TCE
does not exceed the ECEL or lowest achievable exposure level for all
potentially exposed persons within 9 months after the date of
publication of the final rule in the Federal Register, and if
applicable, each owner or operator must provide respiratory protection
sufficient to reduce inhalation exposures to below the ECEL to all
potentially exposed persons in the regulated area within 3 months after
receipt of the results of any exposure monitoring that indicates
exposures exceeding the ECEL or, if using monitoring data conducted
within five years prior to the effective date of the final rule that
satisfies all other requirements of the proposed WCPP, within 9 months
after the date of publication of the final rule in the Federal
Register. EPA is also proposing to require owners and operators
demarcate a regulated area within 3 months after receipt of any
exposure monitoring that indicates exposures exceeding the ECEL.
Regulated entities should then proceed accordingly to implement an
exposure control plan within 12 months after date of publication of the
final rule in the Federal Register. EPA requests comment relative to
the ability of owners or operators to conduct initial monitoring within
6 months after date of publication of the final rule in the Federal
Register, and anticipated timeframes for any procedural adjustments
(i.e., use of new technologies for personal breathing zone monitoring
at extremely low-ppm levels of TCE) needed to comply with the
requirements outlined in this unit, including establishment of a
respiratory protection program and development of an exposure control
plan.
EPA understands that the regulated community may have difficulty
measuring at or below the ECEL consistently over an entire work shift.
Therefore, EPA is requesting comment regarding the amount of time, if
any, it would take the regulated community to develop a method to
measure at or below the ECEL over an entire work shift. EPA is
interested in what levels of detection are possible based on existing
monitoring methods, justification for the timeframe of the specific
steps needed to develop a more sensitive monitoring method, and any
additional detailed information related to establishing a monitoring
program to reliably measure TCE at or below the ECEL.
With regard to the compliance timeframe for those occupational
conditions of use which are subject to dermal protection requirements,
EPA is proposing to require each owner or operator of a workplace
subject to dermal protection requirements to establish dermal
protection outlined in this unit by 6 months after publication of the
final rule in the Federal Register. EPA requests comment relative to
the ability of owners or operators to implement dermal protection
within 6 months of publication of the final rule in the Federal
Register, and anticipated timeframes for any procedural adjustments
needed to comply with the requirements outlined in this unit. EPA may
finalize shorter or longer compliance timeframes based on consideration
of public comments.
3. TSCA Section 6(g) Exemptions
Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if the Agency makes one of three
findings. TSCA section 6(g)(1)(A) permits such an exemption if the
specific condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available.
Under TSCA section 6(g)(1)(B), EPA must find that compliance with the
requirement would significantly disrupt the national economy, national
security, or critical infrastructure to provide an exemption. Finally,
TSCA section 6(g)(1)(C) allows for an exemption based on an EPA finding
that the specific condition of use of the chemical substance or
mixture, as compared to reasonably available alternatives, provides a
substantial benefit to health, the environment, or public safety. Based
on discussions and information provided by industry stakeholders and
consultation with DOD and NASA, EPA has analyzed the need for several
different exemptions and is proposing to grant six. This unit presents
the results of that analysis.
Pursuant to TSCA section 6(g)(3), if an exemption is finalized, EPA
may by rule later extend, modify, or eliminate the exemption, on the
basis of reasonably available information and after adequate public
justification, if EPA determines the exemption warrants a change. EPA
will initiate this rulemaking process at the request of any regulated
entity benefiting from such an exemption. The Agency is open to
engagement throughout the duration of any TSCA section 6(g) exemption
and emphasizes that, to ensure continuity in the event of an extension
or modification, such a request should come at least two years prior to
the expiration of an exemption.
a. Analysis of the Need for TSCA Section 6(g)(1) Exemptions for Uses of
TCE That Are Critical or Essential
i. Analysis of the Need for a TSCA Section 6(G)(1)(B) Exemption for
Industrial and Commercial Use of TCE as a Processing Aid for Battery
Separator Manufacturing (Lead-Acid And Lithium Battery Separators)
As part of industry stakeholder engagement and interagency
consultation with other Federal agencies following publication of the
2020 Risk Evaluation for TCE (Ref. 35 stakeholder meeting list), EPA
was made aware that some U.S. battery separator manufacturers continue
to rely on TCE to manufacture specialty separator materials of lead-
acid and lithium batteries (Refs. 48, 49). In the 2020 Risk Evaluation
for TCE, EPA evaluated the industrial and commercial use of TCE as a
processing aid for battery separator manufacturing. EPA understands
that the manufacture of battery separators takes place separately from
overall battery manufacture, that both lead-acid and lithium batteries
require separators for operation, and that the lead-acid and lithium
battery separator manufacturing processes are highly engineered
specialty products manufactured with precision to stringent technical
specifications essential to power vehicles and systems in the U.S.
supply chain for multiple critical infrastructure sectors within the
national economy.
EPA understands that separators are fundamental components in
batteries that provide the necessary separation between the internal
anode and cathode components that make batteries work, and that a
restriction on TCE use for the production of battery separators would
critically impact the U.S. battery manufacturing supply chain and
impede the expansion of domestic battery production capacity (Refs. 50,
51). Industry stakeholders as well as other Federal agencies have
discussed with EPA the potential adverse implications of banning or
severely restricting use of TCE for battery separator production, as it
would
[[Page 74745]]
disrupt the supply chain and leave the U.S. reliant on foreign
suppliers to the extent that they are available to support the national
economy, national security, and critical infrastructure (Refs. 48, 49).
EPA agrees these assertions have merit. Lead-acid and lithium batteries
are essential to serve critical infrastructure such as transportation
systems, security systems, as well as to energize the national defense
base (e.g., nuclear submarine batteries). Two companies requested that
EPA provide exemptions under TSCA section 6(g) to allow for the
continued use of TCE in the manufacture of battery separators, noting
their significant concern about potential prohibitions under TSCA on
the use of TCE. Both companies emphasized the need for the continued
use of TCE in the manufacture of battery separators to strengthen
critical supply chains by revitalizing domestic manufacturing and
research and development in accordance with Executive Order 14017 (86
FR 11849, March 1, 2021). Additionally, the companies noted that a
potential ban on TCE would be contrary to the Administration's national
security priorities, which are to reduce supply chain risks by building
a robust domestic renewable power sector, transitioning to a clean
energy-based economy, growing a mature and competitive high-capacity
battery industry, and leading global innovation and production in
advanced technology products through a strong domestic manufacturing
base.
One company requested a TSCA section 6(g) exemption for the use of
TCE and described the specific use of TCE as an ``extraction solvent''
during the separator manufacturing process for both lead-acid and
lithium battery separators (Ref. 48). The company makes lead-acid and
lithium battery separators from naphthenic process oil during the
extrusion process in order to form a thin sheet or film for each
separator. During the extrusion process, a precise amount of process
oil must be removed from the separator, which requires the use of a
solvent (i.e., TCE) to rapidly extract the process oil and leave behind
the desired porosity to allow ion flow in each finished battery. The
finished separators must contain a specific percentage of residual
process oil that ranges between 15% to 20% for lead-acid battery
separators (for oxidation resistance in the finished battery) and less
than 1% for lithium separators. Once the solvent has removed the
precise amount of oil from each separator, the solvent must be
evaporated/removed from the separator, and post-evaporation, the
separator must have the specific porosity and wettability to provide
low electrical (ionic) resistance (i.e., enabling ion transport) within
a battery. For these established separator manufacturing processes, TCE
is a high-performance process solvent that provides a unique
combination of chemical properties (e.g., non-flammability, rapid
extrusion of process oil, compatibility with process equipment, etc.),
which facilitate the controlled removal of process oil in both lead-
acid and lithium separator production processes. The company also
detailed that there is no other chemical alternative that is suitable
or available to replace TCE in its lead-acid or lithium separator
processes.
A second company requested a TSCA section 6(g) exemption for the
use of TCE as a necessary solvent for the manufacture of lead-acid
battery separators and indicated that prohibiting the use of TCE would
harm the U.S. manufacturing, energy, transportation, and defense
sectors (Ref. 49). The company describes its use of TCE as specific to
the manufacture of polyethylene plate separators used by others in
commercial wet cell batteries. Their lead-acid battery separators are
made of silica, process oil, and PE resin, a unique polymer that is
extruded into a sheet form using the process oil. After the sheet is
formed, an oil-extraction process employs TCE to extract the process
oil, which reduces the oil content within the sheet to 20-25%, and,
once the solvent has removed the precise amount of oil from the lead-
acid separator, the solvent is evaporated/removed from the separator to
yield the required porosity to allow ion flow in the finished battery.
Finally, the extracted oil and 99.7% of TCE are captured and reused in
the extraction process. The company notes that its lead-acid battery
separators are essential in gasoline and electric-powered commercial
vehicles, emergency response and military vehicles, marine engines,
nuclear power providers, as well as other business sectors. The company
further reiterates the unique chemical properties that are essential to
facilitate the controlled removal of process oil while allowing the
company to recover and recycle previously-used TCE efficiently for
reuse in the battery separator production process in a manner that they
describe as minimizing worker exposure, while resulting in a product
with the characteristics required by battery producers. The company has
provided details to EPA on its sophisticated engineering process that
follows the hierarchy of controls to minimize worker exposure. This
includes a separate enclosed structure under negative pressure as a
work area for TCE processing; limiting the time personnel are allowed
to enter spaces where they could be potentially exposed to 15 minutes
at a time; work area ventilation and filtration using carbon beds; and
PPE including either a half-face or full-face air purifying respirator
for any entry into the work area, as well as chemical-resistant gloves,
chemical-resistant aprons, goggles, and face shields (Ref. 49, 53).
Both companies that requested a time-limited exemption for use of
TCE for battery separator production in the U.S. have demonstrated to
EPA the facility-specific research, development, and implementation of
sophisticated control measures to minimize TCE exposures, while also
searching for reasonably available alternative solvents and processes
(Refs. 48, 49).
According to the requesters, there are several properties that make
TCE uniquely suitable for use in the manufacture of battery separators.
First, TCE is non-flammable. According to one requester, the only other
solvent that is currently in use in this application is hexane, which
is explosive and highly flammable, presenting a safety risk. Other key
properties described by the requesters include TCE's rapid extraction
of process oil, its compatibility with the metallurgy of the process
equipment, the ease by which TCE is distilled from the process oil for
recovery and reuse, and its vapor pressure that both allows for
evaporation and permits condensation from the atmosphere using cooling
coils. One requester evaluated more than a dozen potential
alternatives, including hexane, other chlorinated solvents such as
methylene chloride and perchloroethylene, 1-bromopropane, acetone,
alcohols, siloxanes, and water. Some were eliminated as not being
compatible with the process, such as water, which is not miscible with
the process oil, so it cannot be used to extract the oil. Others were
found to be much less effective than TCE at extracting process oils,
while some were not as easy to recover and reuse. Even the more
promising solvents, such as perchloroethylene, were not drop-in
replacements and would, according to the requester, require expensive
equipment modifications and a multi-year customer approval process.
Based on requester submissions and EPA's general understanding of the
battery separator manufacturing process, EPA believes that there are no
feasible
[[Page 74746]]
alternatives to TCE available at present (Refs. 48, 49, 52).
One company requested a fixed exemption period of 25 years due to
the critical nature of TCE use, current lack of any safer
technologically or economically feasible alternative, and to avoid
grave disruption to the U.S. economy, critical infrastructure, and
defense base (Ref. 54). The company further explained that a
restriction on TCE without sufficient time to identify, develop, and
test a technically and economically feasible alternative (should such
an alternative be identified and become available) would pose
significant cost and safety concerns for the automobile and other
critical infrastructure industries. The requester further explained
that battery manufacturer customers and end users require compliance
with strict performance testing, and, in addition, if a technically
feasible alternative does become available, it will take multiple years
to retrofit and obtain approvals required for the technical, economic
and commercial feasibility of the separators. The company offered to
provide EPA periodic reports every five years on its efforts to
identify and assess feasible alternatives; in this way, EPA would
receive ongoing alternatives analyses to ensure forward progress, while
the company would obtain the regulatory certainty needed to maintain
sustainable production for its customers (Ref. 48).
Similarly, the second company requested a 25-year exemption from
restrictions on this use of TCE, with an additional request that EPA
consider future extensions for additional time, in order to allow its
use of TCE until a safer, feasible alternative is available (Ref. 49).
The company justified the lengthy exemption request by explaining its
ongoing search for alternatives since 2014, and its estimates that,
while it will be another five years before a suitable alternative is
identified, the period for trial use, customer vetting and approval and
construction of a new manufacturing plant is expected to last at least
20 years. In addition, the second requester also offered to submit to
EPA periodic reports every five years to detail their efforts to
identify and assess feasible alternatives.
Based on the information provided to EPA, EPA proposes that
compliance at this time with a prohibition for this specific condition
of use would significantly disrupt national security and critical
infrastructure. EPA agrees that the use of lead-acid batteries and
lithium battery separators is crucial to each of these sectors at this
time. These batteries are essential for critical infrastructure such as
transportation and security systems, as well as for energizing the
national defense base (e.g., nuclear submarine batteries). Furthermore,
EPA agrees that compliance with the prohibition would disrupt national
security priorities of reducing supply chain risks by building a robust
domestic renewable power sector and transitioning to a clean energy-
based economy.
Despite the request for a 25-year exemption from two separate
companies, EPA is proposing a 10-year time-limited TSCA section 6(g)
exemption. EPA believes that a 10-year exemption from the prohibition
on TCE as a processing aid, specific to lead-acid and lithium battery
separator manufacturing, is reasonable because it would be sufficient
to provide EPA with an updated analysis of any technically feasible
alternative, the supply chain of the U.S. battery industry, as well as
global innovation and production in high-technology products. Under
TSCA section 6(g), EPA can consider revisiting or extending time-
limited exemptions by rulemaking until a safer, feasible alternative
becomes available, provided EPA receives an updated analysis of the
specific use. EPA considered the emphasis in TSCA section 6(d) that
compliance dates be as soon as practicable, and that TSCA section 6(g)
requires that any exemptions be well-justified. EPA also took into
consideration the regulatory scheme under the European Chemicals Agency
for this use of TCE for battery separator manufacturing, and the
periodic reporting cycle established in the European Union and United
Kingdom. In the EU and UK, authorizations are chemical- and facility-
specific and for a duration of either 7 or 12 years. Under the current
EU and UK authorizations, in which a panel reviewed the scientific and
economic implications of the specific TCE use, each battery separator
manufacturing company was approved for a 7-year authorization period
(with a 2023 expiration date); both companies have applied for a
renewal for an additional 12 years after 2023 (Ref. 55). Noting that
this industry has been able to provide updated applications for
authorization to the EU and UK in a renewal cycle that has been shorter
than 10 years, the two companies' interest in providing periodic
updates to EPA, and the fast pace of battery technology development,
EPA proposes that 10 years is sufficient for this time-limited
exemption, and that this timeframe would also align with the EU and UK
approaches. EPA requests comment on whether 10 years is an appropriate
timeframe for the proposed TSCA section 6(g) exemption for industrial
and commercial use of TCE as a processing aid for battery separator
manufacturing (lead-acid and lithium battery separators).
ii. Analysis of the Need for a TSCA Section 6(g)(1)(B) Exemption for
TCE Use for DoD Naval Vessels
During the analysis for this rulemaking of the use of TCE, EPA has
identified that it is necessary to allow for the continued use of TCE
for industrial uses for DoD naval vessel requirements for potting,
bonding and sealing compounds, bonding and cleaning requirements for
naval combat systems, radars, sensors, equipment, and fabrication and
prototyping processes.
These naval vessel-related COUs cover the platform itself and/or
specific systems, equipment, or processes. The use of TCE for
industrial uses on DoD naval vessels is critical and essential, and a
prohibition for this specific condition of use would significantly
disrupt national security and critical infrastructure. An exemption for
DoD uses for naval vessels would enable the continued use of TCE for
the COUs described which relate to vessels and their systems, and which
enable maintenance, fabrication and sustainment and thus the operation
of naval vessels and equipment.
DoD has been unable to identify suitable alternatives for TCE for
these uses. Based on information received from DoD, a 10-year timeframe
for this exemption would prevent disruption of national security and
allow critical infrastructure priorities to be met.
iii. Analysis of the Need for TSCA Section 6(g)(1)(A) Exemption of TCE
for Laboratory Use That for Essential Laboratory Activities
During the analysis for this rulemaking of the uses of TCE, EPA
agrees that it is necessary to allow the continued use of TCE for
laboratory use for essential laboratory activities (this use is within
the condition of use ``Industrial and commercial use of TCE in hoof
polish; gun scrubber; pepper spray; and other miscellaneous industrial
and commercial uses,'' described in Unit III.B.1.c.xx.). Under
essential laboratory activities, EPA includes chemical analysis,
chemical synthesis, extracting and purifying other chemicals, or
dissolving other substances. Additionally, EPA includes as an essential
laboratory activity research and development for new technologies
related to monitoring and remediation for cleanup activities
[[Page 74747]]
related to TCE contamination and for new analytical methods for
exposure monitoring (e.g., for the ECEL).
Under TSCA section 6(g)(1)(A), EPA determined that TCE use as a
laboratory chemical for essential laboratory activities is a critical
and essential use with no technically and economically available
substitutes. The use of TCE in laboratory use for essential laboratory
activities is critical for ongoing Federal, state, and local government
cleanup projects, in which it is necessary to use TCE as a laboratory
chemical for the analysis of TCE-contaminated soil, air, and water
samples. In these projects which are specific to TCE, the continued use
of TCE in laboratory settings for chemical analysis when applied to
cleanup and exposure monitoring is critical to efforts to improve
health, the environment, and public safety and is without a technically
available substitute. Additionally, industrial laboratory analysis is
essential in monitoring for the presence of TCE for the adequate
reduction of overall exposure to TCE in alignment with the hierarchy of
controls. In order to accurately conduct exposure monitoring of TCE to
implement the WCPP for the uses with longer timeframes, industrial and
commercial use of TCE as a laboratory chemical to provide for the
chemical analysis of samples is critical and essential and without a
technical alternative. A 50-year timeframe for the continued use of TCE
for uses in a laboratory for chemical analysis would allow a sufficient
time for TCE remediation to occur at most identified clean-up sites, as
well as sites not yet identified. EPA also proposes to include in this
exemption the use by NASA of TCE in essential laboratory activities as
a laboratory reagent, calibration standard, and for dissolving other
substances (Ref. 56). Following interagency consultation with NASA, EPA
understands NASA's critical use of TCE in laboratories to include
sample preparation and equipment calibration related to the search for
chlorinated hydrocarbons on Mars, calibration of gas mixture used in
identification of contaminants in breathing air in human-rated space
and aerospace systems, and preparation of quality assurance samples for
groundwater analysis. EPA is also aware of an additional critical use
of TCE in laboratories by NASA to dissolve substances, such as for wax
removal from infrared sensors. The wax is applied to protect the
sensors during the development of infrared detectors incorporated into
specialty instruments. TCE is used to remove the wax, and, unlike other
solvents, has not been found to damage other delicate components of the
infrared sensors.
As an example of this use, EPA notes that the devices that require
this kind of wax removal are built in the Detector Development Lab,
which is an International Standards Organization 5 cleanroom dedicated
to fabrication of detectors (including infra-red). The lab utilizes
semiconductor like processes to create these devices in silicon wafers
or similar substrates, through build up or removal of layers toward
meeting NASA missions. Detectors and devices are built in the lab that
are not typically found in industry yet are needed to meet NASA
requirements. The devices built tend to be unique, one-of-a-kind
devices created using equally unique and highly specialized processes.
One of these processes uses TCE. Part of device fabrication requires
building up or removing material from both sides of the wafer. To do
so, while protecting one side, a sacrificial substrate is commonly
adhered to the silicon substrate using a wax material as glue. In many
cases, when the process is complete, the wax is dissolved away to
remove the sacrificial substrate. Common waxes that achieve this
process are readily dissolved in a polar solvent such as acetone. The
build-up or removal of material is done in a manner to create very
specific patterns with each layer. These patterns are transferred to
the substrate using a polymer material called photoresist. Once the
pattern transfer is complete the photoresist is removed using acetone
or other means.
In the case of creating certain types of infra-red detectors, there
is a need to embed a photoresist pattern within the wax layer when
gluing a sacrificial substrate to the silicon wafer. The requirement is
that the patterned resist remain intact after dissolving the wax. Using
solvents such as acetone would simultaneously dissolve the resist
pattern or in the case of some solvents deform or weaken the
photoresist beyond rendering it unusable. TCE is the only product
identified that can perform this process. Specifically, TCE is able to
dissolve the wax layer and leave the patterned resist layer
uncompromised. The use of TCE is solely for dissolving material and is
always used in an exhausted hood in the laboratory. Each hood is
inspected yearly by an on-site Industrial Hygiene Office to ensure
proper airflow and operation. The hood has a local alarm for airflow
that is tested daily for operation. The clean room has vertical laminar
air flow, pushing air into the exhausted hoods as air is pulled by the
exhaust fans. The room is maintained at a positive pressure of 0.08
inches on water column. For added exposure reduction, the laboratory is
equipped with a separate emergency exhaust fan which, if activated,
creates a negative pressure in the laboratory. All potentially exposed
persons are provided a full set of PPE that includes apron with arm
guards, face shield, safety glasses, standard issue nitrile gloves and
chemical gloves rated for chlorinated solvents.
The process consists of the following steps: First, the wafer is
soaked in 200-2000 mL of TCE (volume dependent on wafer size). When the
wax is fully dissolved, the wafer is transferred to a second (fresh)
TCE container of 200-2000mL and soaked for several minutes. Then, the
effluent is rinsed with de-ionized water and the waste TCE is captured
in waste containers for disposal by an on-site Environmental Group.
This process is conducted over the span of approximately one week and
is required an average of 3 times per year. When the process is
complete all chemicals are disposed of or stored in screw capped
bottles within an exhausted enclosure. Based on the information
available to EPA, EPA is including the use of TCE in laboratories by
NASA to dissolve substances as part of the proposed exemption for use
of TCE in laboratories for essential laboratory activities. In
addition, based on the information provided by NASA and other Federal
agencies, EPA has considered and is including in this proposal an
exemption for additional research and development activities and test
and evaluation method activities, and similar laboratory activities,
conducted by Federal agencies and their contractors, provided the use
is essential to the agency's mission. As described more fully in Unit
V.A.3.a.vi., for example, NASA's mission requires that it operate at
the cutting edge of science, in environments that are hostile to life,
especially human life. While NASA is skilled at addressing problems
presented by these environments, EPA is concerned that the proposed
limits on this laboratory use exemption in general would negatively
affect NASA's ability to respond to issues that arise in spaceflight,
particularly human spaceflight. Similarly, EPA believes that the DoD's
unique mission requires additional flexibilities for research and
development in order to maintain military readiness at all times.
It should be noted that the use of TCE in laboratory settings for
testing asphalt would not be included in this TSCA section 6(g)
exemption because it is not critical nor essential, and because
alternative testing methods exist,
[[Page 74748]]
including the Nuclear Asphalt Content Gauge and the Ignition Method
(Ref. 57). EPA requests comment on whether 50 years is a reasonable
timeframe for the TSCA section 6(g) exemption for the industrial and
commercial use of TCE in laboratory use essential for chemical
analysis. Specifically, EPA requests comment on the anticipated
duration of TCE cleanup projects, and whether there will be projects
that continue and require the use of TCE as a laboratory chemical for
the analysis of contaminated soil, air, and water samples past 50
years. Additionally, EPA requests comment on if the exemption for
laboratory use of TCE should include research and development purposes
for objectives broader than cleanup activities or exposure monitoring,
such research into TCE alternatives, whether these broader objectives
should be limited to Federal agencies and their contractors or expanded
to include others, and whether a shorter time period, such as 10 years,
should be imposed on these broader research and development activities.
iv. Analysis of the Need for a TSCA Section 6(g)(1)(A) Exemption for
Disposal of TCE to Industrial Pre-Treatment, Industrial Treatment, or
Publicly Owned Treatment Works for the Purposes of Cleanup Projects of
TCE-Contaminated Groundwater and Other Wastewater
EPA has conducted an analysis of the application of this rulemaking
and found that the disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works for the
purposes of cleanup projects of TCE-contaminated groundwater and other
wastewater should be permitted to continue for some period of time to
avoid adverse impacts on these important remediation projects.
TCE is a contaminant of concern in a significant number of cleanup
sites that are managed under the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA), also known as Superfund
sites, as well as under the Resource Conservation and Recovery Act
(RCRA) and state programs authorized under RCRA. The remediation of
these sites, including the removal and treatment of TCE-contaminated
groundwater, is critical to EPA's mission to protect human health and
the environment. The disposal of wastewater that contains TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works is an important method used in these cleanup efforts.
In EPA's analysis of this rulemaking, EPA determined that at many
contaminated sites, TCE-contaminated wastewater is pumped out of the
ground and either sent to offsite industrial treatment or publicly
owned treatment works. EPA acknowledges that the cleanup of these sites
is vital work in which the disposal of TCE is a critical or essential
use for which no technically and economically feasible safer
alternative is available that must continue under CERCLA, RCRA,
authorized state programs, and/or orders or permits issued under those
authorities. Taking into consideration hazards and exposure, a
prohibition on disposal without this exemption could result in
prolonged exposure to TCE-contaminated groundwater for affected
communities. EPA is concerned that eliminating a common disposal method
for TCE-contaminated groundwater would be a significant burden on these
cleanups and would likely slow the pace of remediation at the numerous
sites where TCE-contaminated groundwater is a problem. EPA also
understands that there are other sites where TCE-contaminated
groundwater is being addressed under the authority of other federal
environmental laws or state and local government authorities, including
at sites that are currently implementing remedies selected through
relevant statutory and regulatory processes, and the impact of a
prohibition on an important disposal method is expected to be similar.
EPA therefore is proposing a 50-year exemption from the prohibition on
disposal of TCE by industrial pre-treatment, industrial treatment, or
publicly owned treatment works for cleanup projects undertaken under
the authority of CERCLA, RCRA, or other federal, state, or local
government environmental laws, regulations, or requirements.
A 50-year timeframe for the continued disposal of TCE to industrial
pre-treatment, industrial treatment, or publicly owned treatment works
for the purposes of federal, state, and local government cleanup
projects would allow a sufficient time for TCE remediation to occur at
most sites. Additionally, the 50-year timeframe aligns with the
proposed 50-year time-limited TSCA section 6(g)(1)(A) exemption for
industrial and commercial use of TCE as a laboratory chemical in
essential laboratory activities, which is also intended to support
cleanup operations through allowing for the analysis of samples. EPA
requests comment on whether 50 years is a reasonable timeframe for a
TSCA section 6(g)(1)(A) exemption for the cleanup of TCE-contaminated
water and groundwater sites. Specifically, EPA requests comment on the
anticipated duration of TCE cleanup projects, and whether there will be
projects that may continue and require the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works beyond 50 years.
v. Analysis of the Need for a TSCA Section 6(g)(1)(B) Exemption for
Industrial and Commercial Use of TCE as a Solvent in Closed Loop Vapor
Degreasing Necessary for Human-Rated Rocket Engine Cleaning by NASA and
Its Contractors
EPA has conducted an analysis of the application of this rulemaking
to the industrial and commercial use of TCE as a solvent in closed-loop
vapor degreasing necessary for human-rated rocket engine cleaning by
NASA and its contractors and proposes to find that a TSCA section 6(g)
exemption is warranted. Under TSCA section 6(g)(1)(B), EPA proposes to
determine that a prohibition at this time on the manufacture,
processing, and distribution in commerce of TCE as a solvent for
closed-loop vapor degreasing for human-rated rocket engine cleaning by
NASA and its contractors would significantly disrupt national security
and critical infrastructure.
The United States Space Priorities Framework notes that space
systems (e.g., flight components of satellites and space craft) are
part of the nation's critical infrastructure and that the United States
has significant national security interests in space (Ref. 58). NASA
operates on the leading edge of science seeking innovative solutions to
future problems in environments that offer little to no margin for
error. Identification and qualification of compatible materials in the
context of the less forgiving environments in which NASA operates is an
iterative, collaborative process between original equipment
manufacturers and NASA, especially in the case of human space flight
operations (Ref. 59). NASA's mission architecture requirements often
are developed many years in advance of an actual launch occurring. As
part of mission planning, space systems are designed, full scale mock-
ups are built, and mission critical hardware is constructed using
materials qualified for spaceflight. According to NASA, for Artemis
Program applications, in particular, losing access to a qualified high-
performance substance like TCE in a short period of time has the
potential to introduce an unacceptable level of
[[Page 74749]]
risk to crew, vehicle, and mission viability (Ref. 43).
As described by NASA, their use of TCE in closed-loop vapor
degreasing involves cleaning small diameter parts, such as rocket
engine nozzle coolant tubes, and removing the fluids used for
manufacturing. Substitutes for TCE and alternative processes do not
meet the technical specifications required to clean certain complex
aerospace parts, namely small diameter parts. Specifically, these small
diameter parts cannot be cleaned with other solvents due to the
likelihood of entrapment issues (i.e., a solvent carried out of a
degreaser that adheres to or is entrapped in the part being removed)
(Ref. 60). As discussed in Unit V.B.3.a.i., similar concerns have been
expressed by a manufacturer of commercial jetliners and defense, space,
and security systems, although the manufacturer states that potential
alternatives have been identified for nearly all applications. Given
that the small diameter parts identified by NASA are for human-rated
space flight, there is a rigorous safety standard that must be met, and
according to NASA, TCE is the only solvent currently qualified for
degreasing these specific parts. The engines and devices in which these
parts are used include Space Shuttle engines or hardware being reused;
others are designed to leverage proven Space Shuttle technology and
require use of certain fluids, such as TCE, that have been qualified
for human space flight.
EPA notes that this proposed exemption of use of TCE as a solvent
in closed loop vapor degreasing necessary for human-rated rocket engine
cleaning by NASA and its contractors differs from the exemption for TCE
in vapor degreasing for essential aerospace parts and components,
described in the primary alternative regulatory action. As a principal
matter, this proposed exemption is limited only to NASA and its
contractors due to the critical infrastructure and national security
needs of human-rated spaceflight rocket engines. In contrast, the
alternative is much broader and covers all aerospace entities,
including commercial aviation. This proposed exemption also differs
from the alternative regulatory action in that the exemption is limited
to use of TCE only in closed-loop vapor degreasing, while the
alternative regulatory action would provide an exemption under TSCA
section 6(g) for 7 years before prohibition for all vapor degreasing
with TCE (e.g., open top, in-line conveyorized, in-line web cleaner,
and other types of vapor degreasing in addition to closed loop). Vapor
degreasing as an industry has some of the higher exposures of TCE to
workers and ONUs and this industry would have to make significant
changes in order to comply to the extent possible with a WCPP until
prohibition. However, of the types of vapor degreasing processes,
closed-loop vapor degreasing has the lowest exposures to TCE for
workers and ONUs, and as such, facilities with a closed-loop process
are best situated to comply with an interim WCPP and to the extent
possible, meet the ECEL until prohibition. Further, EPA believes that
the facilities involved in this particular application of vapor
degreasing for human-rated rocket engine cleaning by NASA or their
contractors already have sophisticated industrial hygiene plans in
place. EPA notes that a prohibition on vapor degreasing with TCE for
all uses was proposed in 2017 (Ref. 67). While that proposal was
withdrawn pending the completion of a risk evaluation for TCE under
amended TSCA, which evaluated all conditions of use including vapor
degreasing, EPA expects that since the 2017 proposal, certain
stakeholders have made significant progress in identifying and adopting
substitutes for vapor degreasing with TCE in anticipation of potential
restrictions on TCE under amended TSCA. For instance, EPA is aware that
many users have transitioned to a substitute for TCE in vapor
degreasing where possible or are planning for technologically feasible
adjustments (Refs. 32, 43. 60). EPA requests comment on whether 7 years
is an appropriate timeframe for the proposed TSCA section 6(g)
exemption for industrial and commercial use of TCE in closed loop vapor
degreasing necessary for human-rated rocket engine cleaning by NASA and
its contractors.
vi. Analysis of the Need for TSCA Section 6(g)(1)(A) Exemption for
Certain NASA Uses in an Emergency for Which No Technically or
Economically Feasible Safer Alternative is Available
EPA considered a TSCA section 6(g) exemption for emergency use of
TCE in the furtherance of NASA's mission. For certain specific
conditions of use, EPA proposes that use of TCE by NASA and its
contractors in an emergency be exempt from the requirements of this
rule because it is a critical or essential use provided that (1) there
is an emergency; and (2) NASA selected TCE because there are no
technically or economically feasible safer alternatives available
during the emergency.
NASA operates on the leading edge of science seeking innovative
solutions to future problems where even small volumes of an otherwise
prohibited chemical substance could be vital to crew safety and mission
success. During interagency review, NASA expressed concerns that there
will likely be circumstances where a specific, EPA-prohibited condition
of use may be identified by NASA during an emergency as being needed in
order to avoid or reduce situations of harm or immediate danger to
human health, or the environment, or avoid imperiling NASA space
missions. In such cases, it is possible that no technically and
economically feasible safer alternative would be available that meets
the stringent technical performance requirements necessary to remedy
harm or avert danger to human health, the environment, or avoid
imperiling NASA space missions.
An emergency is a serious and sudden situation requiring immediate
action to remedy harm or avert danger to human health, the environment,
or to avoid imperiling NASA space missions. In NASA's case, there may
be instances where the emergency use of TCE for specific conditions of
use is critical or essential to remedying harm or averting danger to
human health, the environment, or avoiding imperiling NASA space
missions. Because of the immediate and unpredictable nature of
emergencies described in this unit and of the less forgiving
environments NASA operates in that offer little to no margin for error,
it is likely that, at the time of finalization of this proposal,
alternatives to emergency TCE use may not be available in a timely
manner to avoid or reduce harm or immediate danger (Ref. 59). In this
way, these emergencies for particular conditions of use meet the
criteria for an exemption under TSCA section 6(g)(1)(A), because the
emergency use of TCE for listed conditions of use is critical or
essential and no technically and economically feasible safer
alternative will be available in a timely manner, taking into
consideration hazard and exposure.
In support of the TSCA section 6(g)(1)(A) emergency use exemption,
NASA submitted detailed criteria which they must use to screen,
qualify, and implement materials to be used in spacecraft equipment, as
well as historical case studies that outline the loss of life and loss
of assets in the discharge of previous missions. In one of several
examples detailed, the Apollo I command module fire that claimed the
lives of three American astronauts demonstrated the need for careful
testing and continuity of materials (Ref. 59). Moreover, due to NASA's
rigorous safety testing requirements under various environmental
conditions, technically and economically feasible
[[Page 74750]]
safer alternatives may not be readily available during emergencies and
may require certain conditions of use of TCE to alleviate the
emergency.
In another example, NASA identified a scenario concerning a mission
to the International Space Station (ISS) whereby, during a launch
evolution, the countdown was paused immediately prior to launch (T-2
minutes). NASA engineers identified a clogged filter and supply line as
the primary issue, which required immediate attention (i.e., line
flushing and filter cleaning). In this type of emergency scenario, an
already approved chemical substance rated for space system applications
is necessary to immediately remedy the situation. Although TCE was not
used in this particular incident, if it were needed in the future to
address such an emergency, then the proposed exemption would allow for
its lawful use--the countdown would resume and the launch would occur.
Conversely, without an exemption under the specific condition of use
(e.g., industrial and commercial use in cold cleaning), NASA's use of
TCE would be otherwise prohibited, which would put NASA in an untenable
position of having to choose to either violate the law or place the
mission (and potentially the health and safety of its employees
involved in the mission) at risk.
The identification and qualification of compatible materials in the
context of aviation is iterative and involves expansive collaboration
between original equipment manufacturers, federal agencies, and
qualifying institutions. This is equally, if not more so, the case in
the context of human space flight operations undertaken by NASA (Ref.
59). NASA's mission architecture requirements often are developed many
years in advance of an actual launch occurring. As part of mission
planning, space systems are designed, full scale mock-ups are built,
and mission critical hardware is constructed using materials qualified
for spaceflight. Once NASA's mission architecture requirements are
developed, NASA may need to retain emergency access to TCE because its
alternatives may not have yet gone through NASA's rigorous
certification process before their use. Allowing NASA to retain
emergency use of TCE would reduce the chances that this rule will
hinder future space missions for which mission architecture
infrastructure is being developed or is already built. While NASA
considers alternatives to the chemical substances it currently uses in
its space system designs, NASA has not yet identified technically and
economically feasible alternatives to proven chemistries in many
current applications. While EPA acknowledges that the use of TCE in
emergency situations may be necessary in the near term, it is also
EPA's understanding that NASA will continue its work to identify and
qualify alternatives to TCE. Thus, EPA is proposing an exemption
duration of 10 years.
b. Proposed TSCA Section 6(g) Exemptions
i. Proposed 10-Year Exemption for Industrial and Commercial Use of TCE
as a Processing Aid for Battery Separator Manufacturing (Lead-Acid and
Lithium Battery Separators)
For the reasons discussed in this unit, EPA is proposing a 10-year
exemption from the prohibition on the industrial and commercial use of
TCE as a processing aid, specific to battery separator manufacturing.
The proposed conditions for the exemption are: (1) The use of TCE would
be limited to use as a processing aid for battery separator
manufacturing to supply the essential battery components to continue to
support the national economy, national security, and critical
infrastructure; (2) This specific industrial and commercial use of TCE
as a processing aid would be required to be conducted at industrial
facilities already using TCE to manufacture the lithium ion or lead
acid separators; and (3) Owners or operators of facilities where TCE is
used as a processing aid for battery separator manufacturing and
entities that manufacture (including import) TCE as a processing aid
would be required to comply with the WCPP requirements described in
Unit V.A.2. until the expiration of the exemption and the prohibition
compliance date.
ii. Proposed 10-Year Exemption for TCE for Industrial Uses for DoD
Naval Vessel Requirements
For reasons discussed in this unit, EPA is proposing a 10-year
exemption from the prohibition on industrial and commercial use of TCE
for the industrial and commercial use of TCE as potting compounds for
naval electronic systems and equipment; sealing compounds for high and
ultra high vacuum systems; bonding compounds for materials testing and
maintenance of underwater systems and bonding of nonmetallic materials;
and cleaning requirements (which includes degreasing using wipes,
sprays, solvents, and vapor degreasing) for: materials and components
required for military ordinance testing; temporary resin repairs in
vessel spaces where welding is not authorized; ensuring polyurethane
adhesion for electronic systems and equipment repair and installation
of elastomeric materials; various naval combat systems, radars,
sensors, equipment; fabrication and prototyping processes to remove
coolant and other residue from machine parts; machined part
fabrications for naval systems; installation of topside rubber tile
material aboard vessels; and vapor degreasing required for substrate
surface preparation prior to electroplating processes. The proposed
conditions for the exemption are: (1) The use of TCE would be limited
to use only for DoD naval vessels and their systems, and in the
maintenance, fabrication, and sustainment for and of such vessels and
systems; and (2) Owners or operators of facilities where TCE is used
for DoD naval vessels and entities that manufacture (including import)
or process TCE for use in DoD naval vessels would be required to comply
with the WCPP requirements described in Unit V.A.2. until the
expiration of the exemption and the prohibition compliance date.
iii. Proposed 50-Year Exemption for TCE Laboratory Use for Essential
Laboratory Activities
For the reasons discussed in this unit, EPA is proposing a 50-year
exemption from the prohibition on industrial and commercial use of TCE,
for other miscellaneous industrial and commercial use of TCE in
laboratory use for essential laboratory activities, excluding the
testing of asphalt, as previously discussed. The proposed conditions
for the exemption are: (1) The use of TCE would be limited to use in an
industrial or commercial laboratory for essential laboratory
activities, including chemical analysis, chemical synthesis, extracting
and purifying other chemicals, dissolving other substances, and
research and development for the advancement of cleanup activities and
analytical methods for monitoring related to TCE contamination or
exposure monitoring, with the exclusion of laboratory testing for
asphalt; (2) Federal agencies and their contractors would be permitted
to conduct research and development activities and test and evaluation
method activities, and similar laboratory activities, provided the use
is essential to the agency's mission; and (3) Owners or operators of
facilities where TCE is used in laboratory settings and entities that
manufacture (including import) or process TCE for use as a laboratory
chemical would be required to comply with the WCPP requirements
described in Unit V.A.2. until the expiration of the
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exemption and the prohibition compliance date.
iv. Proposed 50-Year Exemption for Disposal of TCE to Industrial Pre-
Treatment, Industrial Treatment, or Publicly Owned Treatment Works for
the Purposes of Cleanup Projects of TCE-Contaminated Groundwater and
Other Wastewater
For the reasons discussed in this Unit, EPA is proposing a 50-year
exemption from the prohibition on disposal of TCE to industrial pre-
treatment, industrial treatment, or publicly owned treatment works for
the purposes of cleanup projects of TCE-contaminated groundwater and
other wastewater. The proposed conditions for the exemption are: (1)
The disposal of TCE to industrial pre-treatment, industrial treatment,
or publicly owned treatment works would only be permitted for the
purposes of cleanup projects of TCE-contaminated water and groundwater
at sites undergoing remediation under CERCLA, RCRA, or other Federal,
state, and local government laws, regulations or requirements; and (2)
Owners and operators of the locations where workers are handling TCE
wastewater, and owners and operators of facilities where TCE is
disposed to industrial pre-treatment, industrial treatment, or publicly
owned treatment works, would be required to comply with the WCPP
requirements described in Unit V.A.2. and the recordkeeping
requirements described in Unit V.A.4. until the expiration of the
exemption and the prohibition compliance date.
v. Proposed 7-Year Exemption for Industrial and Commercial Use of TCE
as a Solvent in Closed-Loop Vapor Degreasing Necessary for Human-Rated
Rocket Engine Cleaning by NASA and Its Contractors
For the reasons discussed in this unit, EPA is proposing a 7-year
exemption from the prohibition on the industrial and commercial use of
TCE as a solvent in closed-loop vapor degreasing necessary for human-
rated rocket engine cleaning by NASA and its contractors, and the
manufacture (including import), processing, and distribution in
commerce of TCE for this use. The proposed conditions for the exemption
are: (1) The use of TCE would be limited to closed-loop vapor
degreasing necessary for human-rated rocket engine cleaning by NASA and
its contractors; and (2) Owners or operators of facilities where TCE is
used in closed-loop vapor degreasing necessary for human-rated rocket
engine cleaning by NASA and its contractors, and entities that
manufacture (including import) or process TCE for such use, would be
required to comply with the WCPP requirements described in Unit V.A.2.
until the expiration of the exemption and the prohibition compliance
date.
vi. Proposed Exemption for Uses of TCE for Emergency Uses in the
Context of Human Space Flight for Certain Uses
For the reasons discussed in this Unit, EPA is proposing a 10-year
exemption for emergency use of TCE in furtherance of NASA's mission for
the following specific conditions of use:
(1) Industrial and commercial use as solvent for open-top or
closed-loop batch vapor degreasing;
(2) Industrial and commercial use as a solvent for cold cleaning;
(3) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner and mold release;
(4) Industrial and commercial use as a lubricant and grease in tap
and die fluid;
(5) Industrial and commercial use as a lubricant and grease in
penetrating lubricant;
(6) Industrial and commercial use as an adhesive and sealant in
solvent-based adhesives and sealants;
(7) Industrial and commercial as a functional fluid in heat
exchange fluid;
(8) Industrial and commercial use in corrosion inhibitors and anti-
scaling agents; and
(9) Industrial and commercial use of TCE as a processing aid.
EPA is also proposing to include additional requirements as part of
the exemption, pursuant to TSCA section 6(g)(4), including required
notification and controls for exposure, to the extent feasible: (1)
NASA and its contractors must provide notice to the EPA Administrator
of each instance of emergency use within 15 days; and (2) NASA and its
contractors would have to comply with the ECEL.
EPA is proposing to require that NASA notify EPA within 15 days of
the emergency use. The notification would include a description of the
specific use of TCE in the context of one of the conditions of use for
which this exemption is being proposed, an explanation of why the use
described qualifies as an emergency, and an explanation with regard to
the lack of availability of technically and economically feasible
alternatives.
EPA expects NASA and its contractors have the ability to implement
a WCPP as described in Unit V.A.2. for the identified uses in the
context of an emergency, to some extent even if not to the full extent
of WCPP implementation. Therefore, EPA is proposing to require that
during emergency use, NASA must comply with the ECEL to the extent
technically feasible in light of the particular emergency.
Under the proposed exemption, NASA and its contractors would still
be subject to the proposed general recordkeeping requirements discussed
in Unit V.A.
EPA requests comment on this TSCA section 6(g) exemption for
continued emergency use of TCE in the furtherance of NASA's mission as
described in this Unit, and whether any additional conditions of use
should be included, in particular for any uses qualified for space
flight for which no technically or economically feasible safer
alternative is available. Additionally, EPA requests comment on what
would constitute sufficient justification of an emergency.
4. Other Requirements
a. Recordkeeping
In addition to the recordkeeping requirements for the WCPP outlined
in this unit, for conditions of use that would not otherwise be
prohibited one year after the effective date of this proposed
regulation, EPA is also proposing that manufacturers, processors,
distributors, and commercial users maintain ordinary business records,
such as invoices and bills-of-lading, that demonstrate compliance with
the prohibitions, restrictions, and other provisions of this proposed
regulation; and to maintain such records for a period of 5 years from
the date the record is generated. EPA is proposing that this compliance
date would begin at the effective date of the rule (60 days following
publication of the final rule in the Federal Register). Recordkeeping
requirements would ensure that owners or operators can demonstrate
compliance with the regulations if necessary. EPA may require more,
less, or different documentation in the final rule based on
consideration of public comments.
b. Downstream Notification
For conditions of use that are not otherwise prohibited under this
proposed regulation, EPA is proposing that manufacturers (including
importers), processors, and distributors, excluding retailers, of TCE
and TCE-containing products provide downstream notification of the
prohibitions through the Safety Data Sheets (SDS) required by OSHA
under 29 CFR 191.1200(g) by adding to sections 1(c) and 15 of the SDS
the following language:
After [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE
[[Page 74752]]
FINAL RULE IN THE FEDERAL REGISTER], this chemical/product is and can
only be domestically manufactured, imported, processed, or distributed
in commerce for the following purposes until the following prohibitions
take effect: (1) Processing as an intermediate (a) for the manufacture
of HFC-134a until [DATE 8.5 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER] and (b) for all other processing as
a reactant/intermediate until [DATE 2 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER]; (2) Industrial and
commercial use as a solvent for open-top batch vapor degreasing until
[DATE 1 YEAR AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER]; (3) Industrial and commercial use as a solvent for closed-
loop batch vapor degreasing until [DATE 1 YEAR AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], except for
industrial and commercial use as a solvent for closed-loop batch vapor
degreasing necessary for human-rated rocket engine cleaning by NASA and
its contractors until [DATE 7 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], and except for industrial and
commercial use as a solvent for closed-loop batch vapor degreasing for
rayon fabric scouring for end use in rocket booster nozzle production
by Federal agencies and their contractors until [DATE 10 YEARS AFTER
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; (4)
Industrial and commercial use in processing aid a) for battery
separator manufacturing until [DATE 10 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER] and b) in process solvent
used in polymer fiber spinning, fluoroelastomer manufacture and
Alcantara manufacture; in extraction solvent used in caprolactam
manufacture; and in precipitant used in beta-cyclodextrin manufacture
until [DATE 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER]; (5) Industrial and commercial uses for DoD naval
vessels and their systems, and in the maintenance, fabrication, and
sustainment for and of such vessels and systems until [DATE 10 YEARS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER];
and (6) Industrial and commercial use for laboratory use for essential
laboratory activities until [DATE 50 YEARS AFTER DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER].
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on use of TCE under
TSCA as well as provide information to commercial end users about
allowable uses of TCE until the prohibition compliance dates.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA is proposing
a two-month period for manufacturers and a six-month period for
processors and distributers to implement the proposed SDS changes
following publication of the final rule.
EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
B. Primary Alternative Regulatory Action
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA
must consider and publish a statement based on reasonably available
information with respect to the reasonably ascertainable economic
consequences of the rule, including consideration of the costs and
benefits and the cost effectiveness of the proposed regulatory action
and one or more primary alternative regulatory actions considered by
the Agency. This unit includes a description of the primary alternative
regulatory action considered by the Agency. An overview of the proposed
regulatory action and primary alternative regulatory actions for each
condition of use is in Unit V.C.
The primary alternative regulatory action described in this notice
of proposed rulemaking (NPRM) and considered by EPA combines
prohibitions and requirements for a WCPP. While in some ways it is
similar to the proposed regulatory action, the primary alternative
regulatory action described in this NPRM differs from the proposed
regulatory action by providing longer timeframes for prohibitions, and
by describing an ECEL based on a different health endpoint (i.e.,
immunotoxicity), as part of the WCPP that would be required for the
conditions of use of TCE that would be permitted to continue for longer
than one year after publication of the final rule until the prohibition
compliance dates. As described in Unit IV.B., this ECEL is based on the
endpoint used for EPA's unreasonable risk determination for TCE under
TSCA, (i.e., immunotoxicity (Ref. 2), rather than the most sensitive
health endpoint (developmental toxicity), which is the basis for the
ECEL for the WCPP under the proposed regulatory action (the rationale
for these differences is described in Unit VI.A.1.a.). EPA requests
comment on this primary alternative regulatory action and whether any
elements of this primary alternative regulatory action described in
this unit should be considered as EPA develops the final regulatory
action. For example, EPA could finalize a rule that includes the longer
timeframes for prohibitions that are included in this primary
alternative regulatory action and the ECEL based on the fetal cardiac
defects endpoint (0.0011 ppm) that is included in the proposed
regulatory action. EPA also requests comment on the practicability of
the timeframes outlined in this unit compared to the timeframes
identified for the proposed regulatory action in Unit V.A.
1. Prohibitions
The primary alternative regulatory action considered by EPA would
prohibit the manufacture (including import) and processing of TCE for
all uses; prohibit the distribution in commerce and industrial and
commercial use of TCE, as well as prohibitions on the disposal of TCE
to industrial pre-treatment, industrial treatment, or publicly owned
treatment works. The primary alternative regulatory action includes
longer compliance timeframes for all prohibitions.
Under the primary alternative action, the prohibitions would follow
a staggered schedule and would generally take effect three months later
than in the proposed regulatory action. Under a compliance timeframe
that would be three months longer than the proposed regulatory action,
the prohibitions for the manufacturing (including import) and
processing would come into effect in 180 days (6 months) for
manufacturers and 270 days (9 months) for processors, except for the
manufacturing and processing associated with certain processing and
industrial and commercial uses described later in this unit, due to
supply chain considerations. Associated with this prohibition, EPA
would prohibit the manufacturing (including import) and processing for
all uses, including for all consumer uses, under the primary
alternative regulatory action.
[[Page 74753]]
The prohibition compliance dates for most industrial and commercial
users would be one year after the publication of the final rule under
the primary alternative regulatory action. However, under the primary
alternative regulatory action, there would be longer timeframes for the
prohibition of some industrial and commercial uses and for the
associated manufacturing (including import) and processing. For all
manufacturing (including import), processing, and industrial and
commercial use of TCE that would continue more than one year after the
publication of the final rule, the WCPP would be in effect until the
respective prohibition compliance dates or, if applicable, expiration
of the TSCA section 6(g) exemption. The WCPP under the primary
alternative would include an ECEL of 0.004 ppm, as described in Units
IV.B. and V.B.2. Furthermore, to aid with the implementation of the
prohibitions under the primary alternative regulatory action, the
prohibitions on distribution in commerce of TCE would take effect
concurrent with the compliance date for the prohibition on the
manufacture and processing TCE for a particular condition of use.
For the two conditions of use that encompass industrial and
commercial batch vapor degreasing (i.e., open-top and closed-loop),
prohibitions under the primary alternative regulatory action described
in this unit would take effect in 24 months for manufacturers, in 27
months for processors, and in 30 months for the industrial and
commercial users of TCE used as a solvent for open-top and closed-loop
batch vapor degreasing after the publication date of the final rule
(with the exception of industrial and commercial use of TCE as a
solvent for closed-loop batch vapor degreasing for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, which is described in Unit V.B.3.).
For certain processing and industrial and commercial conditions of
use, the prohibitions under the primary alternative regulatory action
described in this unit would take effect in two and a half years after
the publication date of the final rule for manufacturers and in three
years after the publication date of the final rule for processors for
two conditions of use: (1) Processing as a reactant/intermediate, and
(2) Industrial and commercial use as a processing aid in: process
solvent used in battery manufacture; process solvent used in polymer
fiber spinning, fluoroelastomer manufacture and Alcantara manufacture;
extraction solvent used in caprolactam manufacture; and precipitant
used in beta-cyclodextrin manufacture. Additionally, a TSCA section
6(g) exemption would be part of the primary alternative regulatory
action for the industrial and commercial use of TCE as a processing aid
(specifically for battery separator manufacture) and industrial and
commercial use of TCE as a solvent for closed-loop batch vapor
degreasing for rayon fabric scouring for end use in rocket booster
nozzle production by Federal agencies and their contractors (see Unit
V.B.3.).
Furthermore, compliance dates for prohibition would vary for
processing TCE as an intermediate (specifically for HFC-134a
manufacture), which would be subject to a longer phaseout, and for the
prohibition of processing TCE as a reactant/intermediate. Under the
primary alternative regulatory action, the manufacturing (including
import) and processing of TCE as an intermediate for the manufacture of
HFC-134a would be prohibited. Under the primary alternative regulatory
action, there would be a nine-and-a-half-year phaseout (with an extra
year to start compliance compared to the eight-and-a-half-year phaseout
for the proposed regulatory action) following the requirements
discussed in this unit. Under the primary alternative regulatory
action, the prohibition would start one year later than under the
proposed regulatory action, and thus the compliance timeframe would be
one year longer than under the proposed regulatory action described in
Unit V.A.1.b. Under the primary alternative regulatory action, a
phaseout on processing of TCE as an intermediate for the manufacture of
HFC-134a would begin at the final rule's effective date and end nine
years and six months after the publication of the final rule. Within 18
months after the publication of the final rule, any facility using TCE
as a feedstock to manufacture HFC-134a in the United States would
establish a baseline within 12 months after the publication of the
final rule of the annual quantity of TCE processed by the facility as a
feedstock to manufacture HFC-134a. While this is similar to the
proposed regulatory action, the timeframes allowed for establishment of
the baseline would be longer under the primary alternative regulatory
action. The manufacturer would use the average of any 12 consecutive
months in the preceding 36 months to calculate the baseline and would
have records that demonstrate how the baseline annual volume was
calculated. Following the establishment of a baseline volume, under the
alternative regulatory action, following a similar four-step phaseout
process described in Unit V.A., the following compliance dates would
take effect after the publication of the final rule: (1) In three years
and six months each manufacturer of HFC-134a who uses TCE as an
intermediate would not be permitted to process TCE as an intermediate
at an annual volume greater than 75 percent of the baseline so
established; (2) In five years and six months each manufacturer of HFC-
134a who uses TCE as an intermediate would not be permitted to process
TCE as an intermediate at an annual volume greater than 50 percent of
the baseline so established; (3) In seven years and six months each
manufacturer of HFC-134a who uses TCE as an intermediate would not be
permitted to process TCE as an intermediate at an annual volume greater
than 25 percent of the baseline so established; and (4) In nine years
and six months each manufacturer of HFC-134a would be prohibited from
using TCE as an intermediate. Additionally, manufacturing (including
import) for this condition of use and distribution in commerce for this
condition of use would follow a corresponding longer phaseout timeframe
to account for the availability of TCE through the supply chain during
the period of the phaseout of processing TCE as an intermediate for the
manufacture of HFC-134a. Under the primary alternative regulatory
action, regulated entities would keep records of the annual quantity of
TCE purchased and processed from the year 2024 until the termination of
all processing of TCE as an intermediate.
EPA requests comment on the practicability of the timeframes
outlined in this unit compared to the timeframes identified for the
proposed regulatory action in Unit V.A.1.c., including consideration of
the need for manufacturing (including import), and distribution in
commerce to continue during the period of the phaseout.
Furthermore, with regard to the prohibition of the disposal of TCE
to industrial pre-treatment, industrial treatment, or publicly owned
treatment works, under the primary alternative regulatory action, the
prohibition would start three months later than under the proposed
regulatory action, and thus the compliance timeframe would be two years
and three months longer than under the proposed regulatory action
described in Unit V.A.4. (description of disposal for the purposes of
this rulemaking is provided in Unit III.B.2.d.). Under the primary
alternative regulatory action, the prohibition described in this unit
would take effect in three years for domestic manufacturers,
processors, and
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industrial and commercial users disposing of TCE to wastewater,
including disposing of TCE-containing wastewater to industrial pre-
treatment, industrial treatment, or publicly owned treatment works. EPA
recognizes there may be challenges in identifying and implementing an
alternative disposal process separate from disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works. EPA requests comment on whether the three-year
alternative timeline would be practicable or whether additional time is
needed, for example, for a regulated entity to implement a change to
their wastewater collection, treatment, or disposal processes or
infrastructure, and what those alternative disposal methods may be.
2. Workplace Chemical Protection Program for Certain Conditions of Use
As in the proposed regulatory action described in Unit V.A.1.,
EPA's primary alternative regulatory action would include a WCPP as a
requirement, which would encompass an ECEL as well as dermal
requirements to reduce inhalation and dermal exposures to TCE. However,
the WCPP under the primary alternative regulatory action would include
an ECEL based on a different health endpoint, immunotoxicity, as
further discussed in this unit. The WCPP would be in place until the
prohibition compliance date for those conditions of use of TCE that
would continue for longer than one year after publication of the final
rule, which would be: manufacturing (including import); processing: as
a reactant/intermediate; incorporation into formulation, mixture or
reaction product; repackaging; recycling; industrial and commercial
use: as a solvent for open-top batch vapor degreasing; industrial and
commercial use as a solvent for closed-loop batch vapor degreasing; and
industrial and commercial use as a processing aid in process solvent
used in battery manufacture; process solvent used in polymer fiber
spinning, fluoroelastomer manufacture and Alcantara manufacture;
extraction solvent used in caprolactam manufacture; and precipitant
used in beta-cyclodextrin manufacture.
As discussed in Unit V.A.2., and for the reasons described in Unit
V., EPA does not believe that long-term implementation of the WCPP
would be a feasible means of addressing unreasonable risk indefinitely
and that prohibition of the affected COUs would ultimately be necessary
to eliminate the unreasonable risk. Under the primary alternative
regulatory action, the WCPP for several conditions of use of TCE would
reduce to the extent possible the unreasonable risk during the time
period before a prohibition would become effective.
For the primary alternative regulatory action, the WCPP would
encompass an ECEL based on immunotoxicity, following the associated
implementation requirements discussed in Unit V.A.2., in addition to
longer timeframes described in this unit. EPA's primary alternative
regulatory action includes an ECEL of 0.0040 ppm (0.021 mg/m3) as an
eight-hour TWA, which is based on the chronic non-cancer occupational
HEC for autoimmunity (Ref. 14). As discussed in Unit VI.A., among the
adverse health effects, the drivers for EPA's revised unreasonable risk
determination for TCE under TSCA were identified as cancer,
immunotoxicity, acute immunosuppression and chronic autoimmunity from
inhalation and dermal exposures (Ref. 2). Therefore, reducing the
remaining exposures to or below the ECEL of 0.0040 ppm would address
the unreasonable risk of injury to health from TCE that is driven by
inhalation exposures in an occupational setting (Refs. 1, 14). If
ambient exposures are kept at or below the eight-hour ECEL of 0.0040
ppm, EPA expects that workers and ONUs would be protected against not
only the chronic non-cancer effects for autoimmunity described in Unit
III.B.2., but also effects resulting from acute non-cancer exposure
(immunosuppression) and cancer. Associated with the ECEL of 0.0040 ppm,
under the alternative regulatory action, EPA would establish an ECEL
action level at half of the eight-hour ECEL, or 0.002 ppm as an eight-
hour time-weighted average.
EPA believes that longer timeframes may facilitate compliance;
therefore, the primary alternative regulatory action would provide
longer timeframes for implementation of a WCPP than the proposed
regulatory action. With a compliance timeframe that would be six months
later than in the proposed regulatory action, the compliance timeframe
for the WCPP under the primary alternative regulatory action would be
extended as follows: regulated entities would establish initial
exposure monitoring according to the process outlined in Unit V.A.2.ii.
within 12 months (in contrast to six months in the proposed regulatory
action described in Unit V.A.2.ii.) and proceed accordingly, based on
the outcome of the initial monitoring. EPA requests comment on the
ability of regulated entities to conduct initial monitoring within 12
months, anticipated timeframes for any procedural adjustments needed to
comply with the requirements, and the extent to which this option could
result in additional exposure, compared to the proposed regulatory
option as described in Unit V.A. Overall, EPA requests comment on the
practicability of the timeframes outlined in this unit, when compared
to the timeframes identified for the proposed regulatory action in Unit
V.A. EPA requests comment on whether any elements of the primary
alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action, e.g., whether
EPA should consider the timeframes for implementation of a WCPP
presented in this primary alternative regulatory action and the ECEL
value presented in the proposed regulatory action.
EPA does not have sufficient information as to whether the
conditions of use that would continue for longer than one year under
the primary alternative regulatory action listed in this unit could
meet requirements of a WCPP for TCE, including an ECEL of 0.0040 ppm
for TCE. Therefore, EPA requests comment on the existing practices
(e.g., engineering controls, administrative controls, PPE) involving
TCE use in these conditions of use, as to whether activities may take
place in closed systems and the degree to which users of TCE in these
sectors could successfully implement an ECEL of 0.0040 ppm, dermal
protection, and ancillary requirements, described in Unit V.A.2., until
the prohibitions would become effective, including for the
manufacturing, processing, and distribution in commerce that account
for the supply chain.
3. TSCA Section 6(g) Exemptions
Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for uses that are critical or
essential. Based on discussions with and information provided by
industry stakeholders and consultation with other Federal agencies, EPA
has analyzed the need for two different exemptions, described in the
proposed regulatory action discussed in Units I.A.3.a. and b., and
would grant both with a longer time limit if the primary alternative
regulatory action described in this NPRM is adopted in the final rule.
Furthermore, under the primary alternative regulatory action, EPA has
analyzed the need for additional exemptions for essential uses of open-
top and closed-loop batch vapor degreasing for aerospace use (including
[[Page 74755]]
for rayon fabric scouring for rocket booster nozzle production) as well
as narrow tubing used in medical devices, and EPA would provide the
additional exemptions if the primary alternative regulatory action
described in this NPRM is adopted in the final rule. (EPA notes that
the use of TCE for vapor degreasing narrow tubing used in medical
devices is not excluded by TSCA section (3)(2)(B)(vi) because TCE is
not intended to become part of the medical device that incorporates the
narrow tubing). This unit presents the results of the analysis for the
requested exemption for industrial and commercial use of TCE in vapor
degreasing, as well as the time limits indicated under the primary
alternative regulatory action.
a. Primary Alternative Analysis of the Need for TSCA Section 6(g)(1)
Exemptions for Uses of TCE That Are Critical or Essential
i. Analysis of the Need for a TSCA Section 6(g)(1)(B) Exemption for
Industrial and Commercial Use of TCE in Vapor Degreasing for Essential
Aerospace Parts and Components
EPA has conducted an analysis of the application of this rulemaking
to the industrial and commercial use of TCE in vapor degreasing and
found that a TSCA section 6(g) exemption may be warranted for certain
aerospace parts and components if the primary alternative regulatory
action considered by EPA is adopted, in its entirety or in relevant
part, in the final rule.
EPA received a request for a TSCA section 6(g) exemption from
prohibition for the use of TCE in vapor degreasing of aerospace parts
from a manufacturer of commercial jetliners and defense, space, and
security systems (Refs. 60 and 61). As the requester describes, they
manufacture and procure these parts and have identified that TCE vapor
degreasing is necessary due to technical challenges with other
substitute chemicals or alternative methods.
The requester has spent many years developing, qualifying, and
implementing alternative materials and processes to replace TCE vapor
degreasing with aqueous cleaning where technically viable. According to
the requester, while the transition to aqueous cleaning has been
successful for many detail parts (e.g., stringers, spars, seat tracks,
brackets, etc.), substitutes and alternative processes do not meet the
technical specifications required to clean certain complex aerospace
parts, specifically, gaseous oxygen tubing systems, non-oxygen tubing,
as well as honeycomb core and rotorcraft mechanical systems. The
requester notes the ongoing research and development activities over
the years for the TCE vapor degreasing uses without viable
alternatives, and highlights that a potential replacement technology
has been identified for vapor degreasing oxygen and non-oxygen tubing
systems. However, for the honeycomb core and rotorcraft mechanical
systems parts, the requestor explains the continued challenge to
identify a replacement solvent due to entrapment issues (i.e., a
solvent carried out of a degreaser that adheres to or is entrapped in
the part being removed) and processing concerns.
The requester notes that an adequate transition period for this
technically challenging aerospace use requires substantial investment
and time to develop viable alternatives. The requester is currently in
the process of identifying a replacement solvent that can adequately
clean, cause no harm to parts, and is not an equally toxic material to
TCE. Based on the submitted request, conversion from vapor degreasing
to aqueous cleaning is a capital-intensive investment that the
requester expects would require several years to plan, permit,
construct, and install. Additionally, the requester notes that the
aerospace industry needs to ensure that aerospace parts meet DOD and
other Federal Aviation Administration (FAA) specifications to ensure
safety of flight. For example, in order to replace the chemical with an
alternative, the requester notes that they must identify, test, and
select an alternative that meets technical requirements derived from
FAA mandated standards for a typical part used in a commercial
aircraft, such as specifications for specific gravity (ASTM D 792),
Water Absorption (ASTM D 750), and other test requirements, which may
be a lengthy process (Ref. 62). According to the information submitted,
certification with FAA could take at least nine months for individual
parts of components or up to several years for major subsystems or
complete aircraft (Ref. 62). The requester also notes that while they
do not know the extent that their supply chain has transitioned away
from use of TCE in vapor degreasing, TCE has been used in vapor
degreasing to meet required levels of cleanliness of certain supplied
parts by long-standing design specifications that are incorporated into
contracts of a complex supply chain. The requester also told EPA the
suppliers are not required to inform the requester of the process they
use to clean parts that the supplier provides to the requester, and the
requester therefore may not know which solvent a supplier has selected
for vapor degreasing or what factors were considered when selecting
cleaning systems. According to the requester, material declarations and
auditing processes to validate usage may be burdensome, considering
that a large portion of the requester's supply chain includes small
suppliers. Due to the concerns raised with transitioning to aqueous
cleaning or another new cleaning method, the requester has requested
that EPA exempt use of TCE in vapor degreasing of aerospace parts for
10 years.
As discussed in this unit, substitute chemicals for vapor
degreasing of aerospace parts may not be available at this time for
meeting the cleanliness standards of certain parts as required by DOD
and FAA specifications or other specifications included in existing
contracts within the supply chain such that significant disruption to
national security and critical infrastructure would occur without a
longer timeframe for transition to an alternative. More time is needed
for companies to make the capital-intensive transition from TCE vapor
degreasing to aqueous cleaning for those parts that can be cleaned
using the aqueous method. In addition, the requester states that they
are continuing to work towards identifying a replacement solvent that
is able to adequately clean complex machining parts and actuation
systems parts without harming them and that is not a regrettable
substitution. Therefore, EPA has preliminarily determined that if the
use of TCE for vapor degreasing were not available in the near term for
aerospace parts, or if industry could not meet the requirements of the
prohibition considered as the proposed regulatory action, compliance
with such requirement could significantly disrupt national security and
critical infrastructure. In addition, due to availability concerns, EPA
has preliminarily determined that a ban on the manufacture, processing,
and distribution in commerce of TCE for vapor degreasing of aerospace
parts could also significantly disrupt national security and critical
infrastructure. A prohibition on the use of TCE for vapor degreasing of
aerospace parts could negatively affect DOD's capability and readiness,
which includes the ability to adequately maintain aircraft. Such a
prohibition could also negatively affect the maintenance of civilian
aircraft and potentially have impacts on the safety of civilian flight.
Similarly, EPA is aware of a highly specific use of vapor
degreasing for
[[Page 74756]]
aerospace components as part of production of booster rocket nozzles
for national security or critical infrastructure uses (Ref. 43). In the
production of booster rocket nozzles, TCE is used in vapor degreasing
as a solvent in rayon fabric scouring, an intensive cleaning process to
remove contaminants. Cleaning is a critical step of this process; if
contaminants are not sufficiently removed in the scouring stage, the
fabric will be degraded during the chemical reaction that occurs during
carbonization which could result in failure of the nozzle during a
launch and catastrophic effects for the rockets.
A Federal agency involved in this use, specifically NASA, has
attempted at length to identify an alternative to TCE in vapor
degreasing; while NASA had preliminarily identified an alternative
solvent, the manufacturer of the substitute chemical announced they
would be voluntarily ceasing production (Ref. 63), making this
alternative solvent no longer viable. NASA has restarted the
identification and qualification of a non-TCE cleaning method. While
aqueous cleaning has been explored as an alternative method of rayon
fabric scouring, it is not a viable alternative as the rayon fiber is
hydrophilic and water can cause damage to the fiber itself, impacting
its ablation performance (Ref. 43). Currently, substitutes and
alternative processes do not meet the technical specifications required
to clean the rayon fabric in order to safely produce and launch rockets
that are important for national security or critical infrastructure.
NASA has provided to EPA an estimated timeline for the identification
and replacement of TCE in the vapor degreasing of this component. The
replacement of TCE involves intense testing as it is part of
spaceflight, notably a new process would have to undergo various rounds
of testing culminating in a full-scale static motor test using a
booster nozzle manufactured with an alternative cleaning solvent. For
NASA specifically, the first opportunity to conduct a full-scale static
motor test with a booster nozzle produced using a non-TCE alternative
would be 2027; before that is planned to occur, NASA has launches
planned with eight booster rockets, which cannot proceed unless all
components are safely produced. Therefore, EPA has preliminarily
determined that if TCE was not available for this sub-use of closed-
loop batch vapor degreasing for this aerospace component, there would
be a significant, disruptive impact on national security and critical
infrastructure. In addition, due to availability concerns, EPA has
preliminarily determined that a ban on the manufacture, processing, and
distribution in commerce of TCE for vapor degreasing of aerospace parts
could also significantly disrupt national security and critical
infrastructure.
ii. Analysis of the Need for a TSCA Section 6(g)(1)(A) Exemption for
Industrial and Commercial Use of TCE in Closed-Loop and Open-Top Batch
Vapor Degreasing for Narrow Tubing Used in Medical Devices
EPA also finds that a TSCA section 6(g)(1)(A) exemption may be
warranted for vapor degreasing of narrow metal tubing used in medical
devices if the primary alternative regulatory action considered by EPA
is adopted in the final rule. According to a manufacturer of metal
tubing for medical devices (Ref. 64), TCE is the only solvent that they
have found that effectively removes all lubricants from their tubing
products, allowing them to meet the stringent cleanliness standards for
medical devices.
Information provided to EPA from the tubing manufacturer indicates
that their tubing products consist of over 20 different alloys
processed with more than 25 different lubricants, for use primarily in
the medical industry. The tubing is incorporated into devices used in
the body for diagnostic and surgical procedures as well as permanent
implants for orthopedic and cardiovascular applications. The tubing
produced by the manufacturer ranges in diameter from 0.005'' to
0.625'', and both the inner and outer diameters of the tubing must be
degreased at various points in the manufacturing process (Ref. 64).
According to this manufacturer, the use of specialty lubricants in
the drawing and annealing processes create unique degreasing demands
for narrow tube manufacturers and TCE has historically been the
industry standard for effective removal of these lubricants.
Cleanliness is paramount, as even the slightest degreasing failure may
cause corrosion, which could result in a critical failure of an
implantable medical device. Alternative solvents such as methylene
chloride or 1-bromopropane are not feasible alternatives for a variety
of reasons, including that they do not always achieve the required
cleanliness standards, could result in a facility exceeding emission
caps under the Clean Air Act, and are also in the process of being
regulated by EPA under TSCA. Other alternative chemicals have been
explored by the manufacturer, such as parachlorobenzotrifluoride, which
is not a hazardous air pollutant under the Clean Air Act. While
promising, this solvent could not remove some of the manufacturer's
lubricants and specialty coatings, thus not meeting the customer's
cleanliness standard. This alternative is also flammable, which would
require additional equipment design and infrastructure to use safely.
The information provided by this manufacturer of tubing for use in
medical devices regarding TCE vapor degreasing is consistent with the
information provided by the aerospace industry regarding challenges
with finding a replacement for TCE in vapor degreasing of tubing. It is
also consistent with information provided to EPA during the public
comment period for EPA's 2017 proposal on TCE in vapor degreasing (82
FR 7432, January 19, 2017). A commenter on that proposal indicated that
aqueous cleaners did not effectively remove most of the materials in
their lubrication system, so effective lubricants and coating systems
would need to be developed that are compatible with aqueous cleaners
(Ref. 65). Experiments with other lubricants were not successful, the
commenter found that lubricants that could be effectively aqueous
degreased were less effective at lubricating, requiring more drawing
steps as well as more cleaning steps. Further, according to this
commenter, aqueous cleaning requires large, heated water tanks and hot
air drying chambers, increasing energy use and industrial effluent
volumes.
In addition, EPA did not impose additional Clean Air Act emission
reductions on aerospace manufacturing and maintenance facilities or on
facilities manufacturing narrow tubing in 2007, recognizing the unique
nature of the vapor degreasing done by these industries. In the 2007
final rule, EPA found that the level of control called for by the 1994
National Emission Standard for Halogenated Solvent Cleaning for
aerospace manufacturing and maintenance and narrow tube manufacturing
facilities reduced hazardous air pollutant emissions to levels that
presented an acceptable level of risk, protected public health with an
ample margin of safety, and prevented any adverse environmental effects
(Ref. 66). As noted in the 2007 final rule, the finding regarding an
``ample margin of safety'' was based on a consideration of the
additional costs of further control as represented by compliance with
emissions limits adapted for these industry sectors, considering
availability of technology, costs and time to comply with further
controls.
[[Page 74757]]
EPA further notes that the term ``narrow tube'' as used in the 2007
final rule was tubing with a portion of the outside diameter being a
quarter of an inch or less, which is different from the diameters
provided by the narrow tube manufacturer (Ref. 64).
EPA acknowledges the importance of properly cleaned narrow tubing
used in medical devices. The failure of a medical device used in a
medical or surgical procedure, or implanted in the body, can have
immediate and significant negative impacts on human health. Further, a
complete prohibition on the use of TCE for vapor degreasing in the near
term could result in shortages of narrow tubing for use in such medical
devices, which would also have significant negative impacts on human
health. Therefore, EPA requests comment on the extent to which the use
of TCE for vapor degreasing of narrow tubing is a critical use for
which no technically and economically feasible safer alternative is
available. In addition, due to availability concerns, a ban on the
manufacture, processing, and distribution in commerce of TCE for vapor
degreasing of narrow tubing used in medical devices could significantly
disrupt a critical use for which no technically and economically
feasible safer alternative is available.
iii. Analysis of the Need for a TSCA Section 6(g)(1)(A) Exemption for
Industrial and Commercial Use of TCE as a Processing Aid for Specialty
Polymeric Microporous Sheet Materials
EPA has conducted an analysis of the application of this rulemaking
to the industrial and commercial use of TCE as a processing aid and
preliminarily found that a TSCA section 6(g)(1)(A) exemption may be
warranted for certain industrial and commercial purposes if the primary
alternative regulatory action considered by EPA is adopted, in its
entirety or in relevant part, in the final rule. As part of industry
stakeholder engagement, EPA was made aware that at least one U.S.
materials manufacturer relies on TCE to manufacture a specialty
microporous sheet material. This company has requested an exemption
under TSCA section 6(g) for the continued use of TCE for this purpose
(Ref. 67).
As the requestor describes, specialty polymeric microporous sheet
materials are fundamental components in the production of critical or
essential products. EPA preliminarily agrees that certain applications
of these specialty polymeric microporous sheet materials are critical
and essential uses for which no technically and economically feasible
safer alternative is available. This exemption on processing TCE would
be limited to processing for applications of the specialty polymeric
microporous sheet materials that are critical and essential,
specifically; driver's licenses and identification cards of U.S. states
and territories; passports (including U.S. passports and e-passports);
labels for chemical drums, complex filtration elements and cartridges
(such as for oil/water and bilge water separations); and for use in
membranes in energy recovery ventilators. Any application of the
specialty polymeric microporous sheet materials for uses not listed
above would not be covered under this exemption.
EPA believes that these uses would preliminarily also qualify for
an exemption under TSCA section 6(g)(1)(B). These critical and
essential products are also important for the national economy,
national security, and critical infrastructure and EPA preliminarily
agrees that compliance with the prohibition within the timeframes
proposed would be disruptive. The proper identification of individuals
is important for maintaining national security and critical
infrastructure. Systems such as travel, healthcare, and law are all
reliant on identification. Further, the proper labeling of chemicals is
important for protecting critical infrastructure. Similarly, complex
filtration elements and cartridges (such as for oil/water and bilge
water separations) and membranes in energy recovery ventilation are
essential for the operations of critical infrastructure.
Each of these products includes the use of TCE in their
development. The requester described the specific use of TCE as a
``process solvent'' during the manufacturing of a ``unique polymeric
microporous sheet material'' (Ref. 67). The company makes the
microporous sheet material using process oil (white mineral oil) during
the extrusion process in order to form a thin plastic sheet containing
55-60% process oil by weight. The process oil is then removed from the
plastic sheet, which requires the use of a solvent (i.e., TCE) to
rapidly extract the process oil and leave behind the desired
microporosity for the material. The requestor describes how specific
microporosity is important for performance of the material. Once the
solvent has removed the oil from the sheet, the solvent must be
evaporated to remove it from the sheet; post-evaporation, the separator
must leave behind the desired microporosity crucial to the performance
of the material. Finally, the extracted oil and much of the TCE is
captured and reused in the extraction process. TCE that is not captured
and reused is released from a discharge stack; the requestor describes
that the air released contains no more than 10 ppm of TCE.
The requestor describes this manufacturing process as well-
established and reliant on TCE as a high-performance process solvent
that provides a unique combination of chemical properties (e.g., non-
flammability, rapid extrusion of process oil, compatibility with
process equipment, etc.). The requestor describes how this unique
combination of properties facilitate the controlled removal of process
oil in the production of the specialty polymeric microporous sheet
material, resulting in the specific microporosity important for the
performance of the material.
The requester has provided some details to EPA on its efforts to
reduce worker exposure to TCE. The exposure mitigation program includes
a separate area under negative pressure for TCE processing and use of
PPE as necessary to comply with the OSHA PEL for TCE (Refs. 67, 10).
While EPA's proposed ECEL is much lower than the OSHA PEL, EPA expects
the requester to make appropriate changes to its worker exposure
mitigation program to comply with the WCPP and attempt to meet the ECEL
to the extent possible for the duration of this exemption.
According to the requester, there are several properties that make
TCE uniquely suitable for use in the manufacture of the specialty
microporous sheet material. The key properties described by the
requester include TCE's rapid extraction of process oil, the ease by
which TCE is distilled from the process oil for recovery and reuse, and
its vapor pressure, which both allows for evaporation and permits
condensation from the atmosphere. TCE is also non-flammable. The
requester evaluated more than a dozen potential alternatives that could
be compatible with their process for manufacturing specialty polymeric
microporous sheet materials, including hexane, trans-1,2-
dichloroethylene, perchloroethylene, and 1-bromopropane. Many of these
substitutes were found to be less effective than TCE at extracting
process oils, while some were not as easily recovered and reused. Even
the more promising solvents, such as perchloroethylene, were not drop-
in replacements and would, according to the requester, require
expensive equipment modifications and a multi-year approval process.
Many of the potential substitute chemicals would need to be blended
with an HFC that is
[[Page 74758]]
being phased out, or the chemical itself is being phased out due to
concern over PFAS or due to high Global Warming Potential. In addition
to these challenges, the requestor describes how any blend would be a
challenging substitute because the different chemicals in the blend
evaporate at different rates and could become flammable during this
process. The requester emphasized that it is using modeling to seek out
potential alternatives, but that further study is required and that
there is no other chemical alternative that is suitable or available to
replace TCE in this process. Based on the requester's submission and
EPA's general understanding of the manufacturing process for the
specialty microporous sheet material, EPA believes that there are no
feasible alternatives to TCE available at present.
While the requester did not describe a time limit for the
exemption, EPA has identified a 15-year time-limited TSCA section 6(g)
exemption under the alternative regulatory action. EPA believes that a
15-year exemption from the prohibition on the industrial and commercial
use of TCE as a processing aid, specific to the manufacturing of
specialty microporous sheet materials, would be reasonable because it
would be sufficient to provide EPA with an updated analysis of any
technically feasible alternative, the supply chain of the U.S.
materials industry, as well as global innovation and production in
high-technology products. Under TSCA section 6(g), EPA can consider
revisiting or extending time-limited exemptions by rulemaking until a
safer, feasible alternative becomes available. EPA requests comment on
whether 15 years is an appropriate timeframe for the proposed TSCA
section 6(g) exemption for industrial and commercial use of TCE as a
processing aid for specialty polymeric microporous sheet materials.
b. Primary Alternative Exemptions for Uses of TCE That Are Critical or
Essential
i. Primary Alternative 15-Year Exemption for Industrial and Commercial
Use as a Processing Aid for Battery Separator Manufacturing (Lead-Acid
and Lithium Battery Separators)
As part of the primary alternative regulatory action, based on the
analysis in Unit V.A.3.a.i., EPA would grant a 15-year exemption from
the prohibition on TCE for the industrial and commercial use as a
processing aid for battery separator manufacturing. The primary
alternative regulatory action differs from the proposed regulatory
action in that it extends the compliance date for the exemption by five
years, allowing a longer timeframe for stakeholders to continue the use
until its prohibition, in recognition of the challenge to transition to
an alternative chemical or process, further discussed in Unit V.B. The
conditions for the exemption under the primary alternative regulatory
action would be: (1) The use of TCE would be limited to use as a
processing aid for battery separator manufacturing to supply the
essential battery components to continue to support the national
economy, national security, and critical infrastructure; (2) this
specific industrial and commercial use of TCE as a processing aid must
be conducted at industrial facilities already using TCE to supply the
lithium ion or lead acid battery components; and (3) Industry
stakeholders who use TCE as a processing aid for battery separator
manufacturing and entities that manufacture (including import),
process, and distribute in commerce TCE to be available as a processing
aid must comply with the WCPP requirements described in Unit V.B.2.,
including meeting the ECEL to the extent possible until the prohibition
compliance date.
ii. Primary Alternative 30-Year Exemption for Industrial and Commercial
Use of TCE in Laboratory Use for Essential Laboratory Activities
As part of the primary alternative regulatory action, based on the
analysis discussed in Unit V.A.3.a.iii., there would be a 30-year
exemption from the prohibition on TCE in other miscellaneous industrial
and commercial use of TCE in laboratory use for essential laboratory
activities. The primary alternative regulatory action differs from the
proposed regulatory action in that it shortens the compliance date by
20 years. The conditions for the primary alternative proposed exemption
are: (1) The use of TCE is limited to uses in an industrial or
commercial laboratory for essential laboratory activities, including
chemical analysis, chemical synthesis, extracting and purifying other
chemicals, dissolving other substances, with the exclusion of
laboratory testing for asphalt; and (2) Stakeholders who use TCE in
laboratory settings and stakeholders who manufacture (including
import), process, and distribute in commerce TCE to be available as a
laboratory chemical must comply with the WCPP requirements described in
Unit V.B.2., including meeting the ECEL to the extent possible until
the prohibition compliance date.
iii. Primary Alternative Seven-Year Exemption for Industrial and
Commercial Use of TCE in Batch Vapor Degreasing for Essential Aerospace
Parts and Components and Narrow Tubing Used in Medical Devices
For the reasons discussed in this unit, EPA would grant a seven-
year exemption from the prohibition as part of the primary alternative
regulatory action for the industrial and commercial use of TCE in batch
vapor degreasing for essential aerospace parts and components and
narrow tubing used in medical devices. While one requester suggested
that an appropriate length of time for an exemption would be 10 years,
and another did not specify, EPA notes that a prohibition on vapor
degreasing with TCE for all uses was proposed in 2017 (Ref. 68). While
that proposal was withdrawn pending the completion of a risk evaluation
for TCE under amended TSCA, which included the evaluation of the vapor
degreasing conditions of use, EPA expects that certain stakeholders
have made significant progress on substitutes since then in
anticipation of similar restrictions on TCE under amended TSCA. For
instance, EPA is aware that many users have transitioned to a
substitute for TCE where possible or are planning for technologically
feasible adjustments (Refs. 32, 43).
The conditions for the exemption would be: (1) TCE could only be
used for batch vapor degreasing of aerospace parts or components
(including rayon fabric) where other alternatives present technical
feasibility or cleaning performance challenges to meet specifications
from other Federal agencies or other long-standing design
specifications that are included in existing contracts, or for batch
vapor degreasing of narrow tubing used in medical devices; and (2)
Industry stakeholders who use TCE for batch vapor degreasing of
aerospace parts or components or narrow tubing used in medical devices
and entities that manufacture (including import), process, and
distribute in commerce TCE to be available for TCE vapor degreasing
would comply with the WCPP requirements described in Unit V.B.2. to the
extent possible until the prohibition compliance date. EPA requests
comments on all aspects of the exemption request and the exemption in
the primary alternative regulatory action from the prohibition on use
of TCE in batch vapor degreasing, including whether compliance with the
WCPP should also be required during the period of the exemption.
Additionally, EPA is soliciting comment on whether
[[Page 74759]]
it should specify the type of batch vapor degreasing operation, such as
open-top or closed loop batch vapor degreasing, that would be exempt
from prohibition as part of the primary alternative regulatory action
for the industrial and commercial use of TCE in batch vapor degreasing
for essential aerospace parts and components and narrow tubing for
medical devices. EPA also requests comment whether it should consider
different exemption timeframes for different types of vapor degreasing
operations.
iv. Primary Alternative 15-Year TSCA Section 6(G)(1)(A) Exemption for
Industrial and Commercial Use of TCE as a Processing Aid for Specialty
Polymeric Microporous Sheet Materials
As part of the primary alternative regulatory action, based on the
analysis in Unit V.A.3.c., EPA would grant a 15-year exemption from the
prohibition on TCE for the industrial and commercial use as a
processing aid for specialty polymeric microporous sheet material
manufacturing. Under the primary alternative regulatory action, in
accordance with TSCA section 6(g)(4), the conditions for the exemption
that EPA believes are necessary to protect health and the environment
would be: (1) The use of TCE would be limited to use as a processing
aid for the manufacturing of specialty polymeric microporous sheet
materials; and (2) Stakeholders who use TCE as a processing aid for the
manufacturing of specialty polymeric microporous sheet materials and
entities that manufacture (including import), process, and distribute
in commerce TCE to be available as a processing aid must comply with
the WCPP requirements described in Unit V.B.2., including meeting the
ECEL to the extent possible until the prohibition compliance date. EPA
requests comments on all aspects of the exemption in the primary
alternative regulatory action from the prohibition on industrial and
commercial use of TCE as a processing aid, specific to the
manufacturing of specialty microporous sheet materials, including
whether compliance with the WCPP should also be required during the
period of the exemption. EPA also requests comment on whether 15 years
would be an appropriate timeframe for a TSCA section 6(g)(1)(A)
exemption for this use.
C. Overview of Conditions of Use and Proposed Regulatory Action and
Primary Alternative Regulatory Action
Table 2 is a side-by-side depiction of the proposed regulatory
action with the primary alternative action for each condition of use
identified as driving the unreasonable risk (Ref. 2). The purpose of
this table is to succinctly convey to the public the major differences
between the proposed regulatory action and the primary alternative
regulatory action; as such the actions in each column are truncated and
do not necessarily reflect all the details of the proposed and
alternative regulatory action, including differences in timeframes. EPA
notes that ``prohibit + WCPP'' listed in the table indicates that a
condition of use would be prohibited, but in the time before the
prohibition goes into effect, there would be a WCPP. For the proposed
action, the WCPP would include an ECEL of 0.0011 ppm based on the fetal
cardiac defects endpoint so that the developing fetus is best protected
(see Unit V.A.), especially for the sensitive PESS group of older
pregnant workers and ONUs (the group identified as most susceptible to
fetal cardiac defects), while under the primary alternative regulatory
action, the WCPP would include an ECEL of 0.0040 ppm based on the
immunotoxicity endpoint (see Unit V.B.). The rationale for these
differences is detailed in Unit VI.A.1.
The proposed and alternative regulatory actions are described more
fully in Units V.A. and B.
Table 2--Overview of Proposed Regulatory Action and Alternative
Regulatory Action by Conditions of Use
------------------------------------------------------------------------
Action
-------------------------------------------
Condition of use Proposed regulatory Primary alternative
action \1\ action
------------------------------------------------------------------------
Manufacturing: domestic Prohibit + WCPP Prohibit + WCPP
manufacture. includes an ECEL of includes an ECEL of
0.0011 ppm for 0.0040 ppm for
inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
Manufacturing: import....... Prohibit + WCPP Prohibit + WCPP
includes an ECEL of includes an ECEL of
0.0011 ppm for 0.0040 ppm for
inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
Processing: processing as a Prohibit; includes a Prohibit; includes a
reactant/intermediate. phaseout of TCE for phaseout of TCE for
processing as an processing as an
intermediate for intermediate for
the manufacture of the manufacture of
HFC-134a + WCPP HFC-134a + WCPP
includes an ECEL of includes an ECEL of
0.0011 ppm for 0.0040 ppm for
inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
Processing: incorporation Prohibit + WCPP Prohibit + WCPP
into a formulation, includes an ECEL of includes an ECEL of
mixture, or reaction 0.0011 ppm for 0.0040 ppm for
product. inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
Processing: incorporation Prohibit............ Prohibit.
into articles.
Processing: repackaging..... Prohibit + WCPP Prohibit + WCPP
includes an ECEL of includes an ECEL of
0.0011 ppm for 0.0040 ppm for
inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
Processing: recycling....... Prohibit + WCPP Prohibit + WCPP
includes an ECEL of includes an ECEL of
0.0011 ppm for 0.0040 ppm for
inhalation inhalation
exposures to TCE as exposures to TCE as
an eight-hour TWA an eight-hour TWA
based on based on
developmental immunotoxicity.
toxicity.
[[Page 74760]]
Industrial and commercial Prohibit............ Prohibit; includes a
use as a solvent for open- TSCA section 6(g)
top batch vapor degreasing. exemption for the
industrial and
commercial use as
solvent for open-
top batch vapor
degreasing for
essential aerospace
use + WCPP includes
an ECEL of 0.0040
ppm for inhalation
exposures to TCE as
an eight-hour TWA
based on
immunotoxicity.
Industrial and commercial Prohibit; includes a Prohibit; includes a
use as a solvent for closed- phaseout of TCE for TSCA section 6(g)
loop batch vapor degreasing. industrial and exemption for the
commercial use as a industrial and
solvent for closed commercial use as
loop batch vapor solvent for closed-
degreasing for loop batch vapor
rayon fabric degreasing for
scouring for end essential aerospace
use rocket booster use and medical
nozzle production tubing + WCPP
by Federal Agencies includes an ECEL of
and their 0.0040 ppm for
contractors and a inhalation
TSCA section 6(g) exposures to TCE as
exemption for an eight-hour TWA
industrial and based on
commercial use as a immunotoxicity.
solvent for closed
loop batch vapor
degreasing
necessary for human-
rated rocket engine
cleaning by NASA
and its
contractors+ WCPP
for one sub-use
includes an ECEL of
0.0011 ppm for
inhalation
exposures to TCE as
an eight-hour TWA
based on
developmental
toxicity.
Industrial and commercial Prohibit............ Prohibit.
use as a solvent for in-
line conveyorized vapor
degreasing.
Industrial and commercial Prohibit............ Prohibit.
use as a solvent for in-
line web cleaner vapor
degreasing.
Industrial and commercial Prohibit............ Prohibit.
use as a solvent for cold
cleaning.
Industrial and commercial Prohibit............ Prohibit.
use as a solvent for
aerosol spray degreaser/
cleaner and mold release.
Industrial and commercial Prohibit............ Prohibit.
use as a lubricant and
grease in tap and die fluid.
Industrial and commercial Prohibit............ Prohibit.
use as a lubricant and
grease in penetrating
lubricant.
Industrial and commercial Prohibit............ Prohibit.
use as an adhesive and
sealant in solvent-based
adhesives and sealants;
tire repair cement/sealer;
mirror edge sealant.
Industrial and commercial Prohibit............ Prohibit.
use as a functional fluid
in heat exchange fluid.
Industrial and commercial Prohibit............ Prohibit.
use in paints and coatings
as a diluent in solvent-
based paints and coatings.
Industrial and commercial Prohibit............ Prohibit.
use in cleaning and
furniture care products in
carpet cleaner and wipe
cleaning.
Industrial and commercial Prohibit............ Prohibit.
use in laundry and
dishwashing products in
spot remover.
Industrial and commercial Prohibit............ Prohibit.
use in arts, crafts, and
hobby materials in
fixatives and finishing
spray coatings.
Industrial and commercial Prohibit............ Prohibit.
use in corrosion inhibitors
and anti-scaling agents.
Industrial and commercial Prohibit; includes a Prohibit; includes
use as a processing aid for TSCA section 6(g) TSCA section 6(g)
battery separator exemption for the exemptions for the
manufacturing and for the industrial and industrial and
manufacturing of specialty commercial use as a commercial use as a
polymeric microporous sheet processing aid for processing aid for
materials; process solvent battery separator battery separator
used in polymer fabric manufacturing + manufacturing and
spinning, fluoroelastomer WCPP includes an for the
manufacture and Alcantara ECEL of 0.0011 ppm manufacturing of
manufacture; extraction for inhalation specialty polymeric
solvent used in caprolactam exposures to TCE as microporous sheet
manufacture; precipitant an eight-hour TWA materials + WCPP
used in beta-cyclodextrin based on includes an ECEL of
manufacture. developmental 0.0040 ppm for
toxicity. inhalation
exposures to TCE as
an eight-hour TWA
based on
immunotoxicity.
Industrial and commercial Prohibit............ Prohibit.
use as ink, toner and
colorant products in toner
aid.
Industrial and commercial Prohibit............ Prohibit.
use in automotive care
products in brake parts
cleaner.
[[Page 74761]]
Industrial and commercial Prohibit............ Prohibit.
use in apparel and footwear
care products in shoe
polish.
Industrial and commercial Prohibit; includes a Prohibit; includes a
use in hoof polish; gun TSCA section 6(g) TSCA section 6(g)
scrubber; pepper spray; exemption for the exemption for the
other miscellaneous industrial and industrial and
industrial and commercial commercial use as a commercial use as a
uses. laboratory chemical laboratory chemical
for essential for essential
laboratory laboratory
activities and some activities + WCPP
research and includes an ECEL of
development 0.0040 ppm for
activities + WCPP inhalation
includes an ECEL of exposures to TCE as
0.0011 ppm for an eight-hour TWA
inhalation based on
exposures to TCE as immunotoxicity.
an eight-hour TWA
based on
developmental
toxicity.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
brake and parts cleaners.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
aerosol electronic
degreaser/cleaner.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
liquid electronic degreaser/
cleaner.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
aerosol spray degreaser/
cleaner.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
liquid degreaser/cleaner.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
aerosol gun scrubber.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
liquid gun scrubber.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
mold release.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
aerosol tire cleaner.
Consumer use as a solvent in Prohibit \2\........ Prohibit.\2\
liquid tire cleaner.
Consumer use as a lubricant Prohibit \2\........ Prohibit.\2\
and grease in tap and die
fluid.
Consumer use as a lubricant Prohibit \2\........ Prohibit.\2\
and grease in penetrating
lubricant.
Consumer use as an adhesive Prohibit \2\........ Prohibit.\2\
and sealant in solvent-
based adhesives and
sealants.
Consumer use as an adhesive Prohibit \2\........ Prohibit.\2\
and sealant in mirror edge
sealant.
Consumer use as an adhesive Prohibit \2\........ Prohibit.\2\
and sealant in tire repair
cement/sealer.
Consumer use as a cleaning Prohibit \2\........ Prohibit.\2\
and furniture care product
in carpet cleaner.
Consumer use as a cleaning Prohibit \2\........ Prohibit.\2\
and furniture care product
in aerosol spot remover.
Consumer use as a cleaning Prohibit \2\........ Prohibit.\2\
and furniture care product
in liquid spot remover.
Consumer use in arts, Prohibit \2\........ Prohibit.\2\
crafts, and hobby materials
in fixative and finishing
spray coatings.
Consumer use in apparel and Prohibit \2\........ Prohibit.\2\
footwear products in shoe
polish.
Consumer use in fabric spray Prohibit \2\........ Prohibit.\2\
Consumer use in film cleaner Prohibit \2\........ Prohibit.\2\
Consumer use in hoof polish. Prohibit \2\........ Prohibit.\2\
Consumer use in toner aid... Prohibit \2\........ Prohibit.\2\
Disposal to industrial pre- Prohibit the Prohibit.
treatment, industrial disposal of TCE to
treatment, or publicly industrial pre-
owned treatment works. treatment,
industrial
treatment, or
publicly owned
treatment works;
with a TSCA section
6(g) exemption for
the disposal of TCE
from cleanup
projects.
------------------------------------------------------------------------
\1\ Does not include exemptions under TSCA section 6(g); for certain
industrial and commercial uses of TCE for DoD naval vessels and their
systems, and in the maintenance, fabrication, and sustainment for and
of such vessels and systems + WCPP, which includes an ECEL of 0.0011
ppm for inhalation exposures to TCE as an eight-hour TWA based on
developmental toxicity; or for the emergency industrial and commercial
use of TCE in furtherance of the NASA mission for specific conditions
that are critical or essential and for which no technically and
economically feasible safer alternative is available + WCPP, which
includes an ECEL of 0.0011 ppm for inhalation exposures to TCE as an
eight-hour TWA based on developmental toxicity.
\2\ Prohibit manufacture, processing, and distribution in commerce for
the consumer use.
[[Page 74762]]
VI. Rationale for the Proposed Regulatory Action and Primary
Alternative Regulatory Action
This unit describes how the considerations described in Unit
III.B.3. were applied when selecting among the TSCA section 6(a)
requirements to arrive at the proposed and primary alternative
regulatory actions described in Unit V.
A. Consideration of Risk Management Requirements Available Under TSCA
Section 6(a)
1. Proposed Regulatory Action
a. Prohibition
EPA considered a prohibition as a regulatory option and is
proposing it for all manufacturing (including import), processing,
distribution in commerce, use, and certain types of disposal of TCE
(Unit V.A.). EPA proposes that prohibition is necessary to address the
unreasonable risk for all occupational conditions of use after taking
into consideration other combinations of controls such as a non-
prescriptive WCPP or prescriptive controls (i.e., engineering controls,
administrative controls, and PPE). As described in Unit V.A., EPA's
bases for the need for this regulatory approach are similar to those
for the Agency's determination of unreasonable risk, and include
severity of the hazard, exposed populations, magnitude of risk, and
uncertainties (Ref. 2). Throughout this proposed rule, EPA has
described the severity of the hazard of TCE (including immunotoxicity,
developmental, and cancer risks), based on the 2020 Risk Evaluation for
TCE, as well as the populations exposed to the 52 conditions of use
that drive the unreasonable risk, which include numerous workers, ONUs,
consumers, and bystanders, including PESS such as workers of
reproductive age (in particular, older pregnant women).
The significance of the magnitude of exposures for TCE is
highlighted when considering the margins of exposure (MOEs, or the
health point of departure for an endpoint divided by the exposure
concentration) in the risk evaluation that estimate non-cancer risk for
acute and chronic exposure. Estimated MOEs are compared to a benchmark,
described in more detail in the risk evaluation, as part of the
unreasonable risk determination (Refs. 1, 2). An MOE lower than the
benchmark supports a determination of unreasonable risk of injury to
health, based on noncancer effects. As an example, for commercial use
of TCE in open top vapor degreasing, the chronic MOE for fetal cardiac
defects is 0.0006, which is several orders of magnitude lower than then
benchmark of 10. Even with engineering controls, the only way to reduce
exposures more than 1,000-fold would be PPE with an APF of 10,000 (Ref.
1). This level of APF would require workers to constantly wear a full-
face self-contained breathing apparatus (SCBA) in pressure demand mode
or other positive pressure mode, which is considered unsustainable for
the long-term and the least preferred approach to worker protection in
the hierarchy of controls. There are many documented limitations to
successful implementation of respirators with an APF of 10,000,
including difficulties in fit and use rendering them ineffective in
actual application, preventing the assurance of consistent and reliable
protection, regardless of the assigned capabilities of the respirator
(Refs. 69, 70) (63 FR 1152, January 8, 1998). EPA requests comments on
subsections of conditions of use, which by nature of their infrequent
occurrence, could meet the ECEL without having their employees wear
high APF levels of PPE on a daily basis. Given that the magnitude of
risk from TCE is so high, and that the extremely high level of PPE
would be an ineffective long-term way of addressing that risk along
with information provided by stakeholders, including during
consultations (Refs. 70, 31), EPA has significant uncertainty that any
measures short of prohibition would be sufficient to address the
unreasonable risk. Therefore, EPA proposes that prohibition is the
preferred option to ultimately address unreasonable risk. EPA believes
that the extremely low ppm level of the ECEL, while fully addressing
unreasonable risk, will be infeasible for industry to reliably meet due
to the need for a combination of engineering, administrative controls,
and full-face, self-contained, air-supplied respirators. As such, the
only way to protect human health consistently, reliably, and
continually from unreasonable risk would be to prohibit TCE.
Ultimately, a prohibition would result in elimination of
unreasonable risk from TCE, rather than allowing TCE use to continue in
perpetuity, which would necessitate burdensome requirements to achieve
exposure reductions to implement a technically challenging long-term
program to meet a very low exposure limit. Recognizing that longer
compliance timeframes and TSCA section 6(g) time-limited exemptions
would nevertheless be necessary for certain critical uses to continue
for a period of time as, described previously in Units V.A.1.d.,
V.A.1.e., and V.A.1.f., it is necessary to protect workers, including
PESS, such as older pregnant workers and ONUs (the group identified as
most susceptible to fetal cardiac defects). Therefore, as described in
Unit IV., EPA is proposing the WCPP ECEL of 0.0011 ppm, based on the
fetal cardiac defects endpoint, so that the developing fetus is best
protected. EPA's primary alternative regulatory option bases the WCPP
ECEL for TCE on the immunotoxicity endpoint. Because it would not be as
protective for the subset of PESS that include older pregnant workers
and ONUs as specific under TSCA section 6(b), the ECEL based on
immunotoxicity was not put forth as the proposed ECEL. In other words,
under the immunotoxicity ECEL of 0.0040 ppm, workers and ONUs would be
protected from immunosuppression resulting from an acute (eight-hour)
exposure, and from an excess risk of cancer resulting from lifetime
exposure, as well as other adverse health effects such as reproductive
toxicity, liver toxicity, kidney toxicity, and neurotoxicity. When the
ECEL of 0.0011 ppm based on fetal cardiac defects is used, EPA expects
that a fetus would be protected from the effects of maternal exposure
by workers and ONUs, in addition to the protections noted previously.
Given this gap in protectiveness, the immunotoxicity ECEL of 0.0040 ppm
is being considered as the alternative regulatory option rather than
the proposed approach. As noted in Unit V.A.2., EPA has significant
uncertainty about the extent to which some members of the regulated
community could measure or reliably meet either the ECEL of 0.0011 ppm
(in the proposed WCPP) or the ECEL of 0.0040 ppm (in the primary
alternative regulatory action), which contributes to EPA's proposal
that prohibition is the best long-term risk management option for TCE.
EPA understands that additional time may be necessary for certain
processing and industrial and commercial conditions of use to achieve a
full prohibition, including the need for upstream manufacturing,
processing, and distribution in commerce for those uses to continue to
ensure availability for the supply chain. In particular, EPA recognizes
that processing TCE as a reactant/intermediate often takes place in
unique closed-systems, and facilities processing TCE may need
additional time to transition to adjust the physical plant design to
accommodate an alternative manufacturing process or chemical substance
and avoid significantly disrupting the supply
[[Page 74763]]
chain. For example, EPA understands that the manufacturing (including
import) and processing of TCE as an intermediate for the manufacture of
HFC-134a is expected to phase down (absent a TSCA prohibition) over
time as users move to more climate-friendly alternatives under the
requirements of the AIM Act. In this instance, EPA is proposing
requirements as part of a WCPP to reduce the worker exposures to TCE
until the prohibition compliance date. In addition, EPA recognizes that
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production by Federal agencies and their contractors is
a highly specific use with a uniquely long qualification process for
alternatives. In the production of booster rocket nozzles, TCE is used
in vapor degreasing as a solvent in rayon fabric sourcing, an intensive
cleaning process to remove contaminants. This rayon fabric is then
carbonized as part of an ablative process in the nozzle production and
used to line the inside of the nozzles on booster rockets (Ref. 43).
Cleaning is a critical step of this process; if contaminants are not
sufficiently removed in the scouring stage, the fabric will be degraded
during the chemical reaction that occurs during carbonization, which
could result in failure of the nozzle during a launch and catastrophic
effects for the rockets.
For this use, NASA has presented information to EPA on the
necessity of additional time to transition to an alternative, given
that 8 rocket launches are planned using booster sets with a component
produced with TCE (Ref. 43). These launches could not occur if
prohibition occurred on a shorter timeframe. In particular, given the
end use of the components in human-rated spaceflight, EPA recognizes
that NASA must conduct an array of tests to qualify an alternative
solvent to TCE, including a variety of booster rocket function tests
culminating in a full-scale static motor test. Even if an alternative
were identified and qualified through a successful testing cycle,
additional time would be needed for updates to workflows and production
of new booster nozzles (Ref. 43). As such, EPA has provided additional
time for the industrial and commercial use as a solvent for closed-loop
batch vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production by Federal agencies and their contractors.
EPA recognizes that other Federal agencies may also rely on rayon
fabric scouring for their rocket booster nozzle production and so
proposes that the phaseout for this sub-set of the industrial and
commercial use of TCE as a solvent in closed-loop batch vapor
degreasing apply to Federal agencies generally and their contractors.
As a condition for the phaseout, EPA has specified that a final pre-
launch test of rocket booster nozzles without using TCE must be
conducted within 5 years, with a full prohibition in 10 years on the
use of TCE in scouring rayon fabric for end use in nozzles in rocket
boosters. For this phaseout period, EPA is proposing requirements as
part of a WCPP to reduce the worker exposures to TCE until the
prohibition compliance date, and Unit V.A.2. explains that the
establishment of a WCPP is intended to allow more flexibility to
regulated entities than requiring specific prescriptive controls.
Similarly, EPA is proposing the WCPP to reduce to the extent possible
the unreasonable risk until the prohibition compliance date for certain
conditions of use that would be permitted to continue for longer than a
year after publication of the final rule, as discussed in Unit V.A.
Additionally, prohibition is the preferred option for occupational
conditions of use where reasonably available information suggests
minimal ongoing use or when feasible safer alternatives are reasonably
available. As described in this unit, EPA is highly uncertain as to
whether users could comply with the requirements of a TCE WCPP, and EPA
is also concerned with the severity of the risks of TCE. EPA notes the
prevalence of alternative processes and products (Unit VI.B.). In some
cases, reasonably available information indicating a use is no longer
ongoing (Refs. 71, 3), has led EPA to propose more immediate
prohibitions for most industrial and commercial uses of TCE, including
the upstream manufacturing, processing, and distribution in commerce
for those uses. EPA requests public comment on the rationale for
proposing prohibitions as the preferred risk management approach. In
addition, EPA requests comment regarding the number of businesses and
other entities that could potentially close as well as associated costs
with a prohibition of TCE for the industrial and commercial conditions
of use identified in Unit V.A.1.
TSCA section 6(a)(2) provides EPA with the authority to prohibit or
otherwise restrict the manufacture (including import), processing, or
distribution in commerce of a substance or mixture ``for a particular
use'' to ensure that a chemical substance no longer presents
unreasonable risk. For this rulemaking, EPA proposes that ``for a
particular use'' include consumer use, which encompasses all known,
intended, and reasonably foreseen consumer uses for TCE (Ref. 1). Given
the severity and ubiquitous nature of the risks identified in the 2020
Risk Evaluation for TCE for processing of TCE into formulation as well
as for all but one consumer use (pepper spray) and, noting that those
conditions of use encompass all known, intended, and reasonably
foreseen consumer use, EPA proposes that prohibiting manufacture
(including importing), processing, and distribution in commerce of TCE
for consumer use is reasonable and necessary to address the
unreasonable risk from TCE driven by manufacturing (including
importing) and processing TCE into formulation (the upstream conditions
of use for products intended for consumer use), and that this proposed
approach will also address the unreasonable risk to consumers and
bystanders. Furthermore, amongst the broad prohibition of TCE, EPA
considered and acknowledges the likely future unavailability of TCE for
the consumer use of pepper spray, and EPA expects the prohibition on
industrial and commercial use of TCE in pepper spray, as well as the
upstream prohibition on manufacturing, processing, and distribution of
TCE for commercial or consumer uses, would result in no TCE-containing
pepper spray being produced for consumer use (Ref. 71).
Details of the proposed prohibitions are described in more detail
in Unit V.A.
b. Workplace Chemical Protection Program (WCPP)
i. Overall. Prohibition is the preferred option for all
occupational COUs, because significant uncertainty exists relative to
any sector's ability to comply with a notably low exposure limit for
TCE, particularly given the magnitude of exposure for many conditions
of use (see Unit V.A.1.). A more immediate prohibition is the preferred
option for occupational conditions of use where greater uncertainty
exists relative to a sector's ability to comply with provisions of a
WCPP, in particular a very low ECEL, as well as additional requirements
that would support implementation of these restrictions (described in
Unit V.A.2.). The 8-hour TWA ECEL of 0.0011 ppm for TCE that EPA is
proposing, based on the developmental toxicity endpoint, is
significantly lower than the OSHA PEL of 100 ppm, and there is a high
degree of uncertainty as to whether users under the conditions of use
in any sector would be able to comply with such a level and, thus,
whether the
[[Page 74764]]
unreasonable risk would be addressed. However, to address, to the
extent possible, the unreasonable risk during the time period before a
prohibition would become effective, EPA is proposing a WCPP until the
prohibition compliance date. The WCPP would include a combination of
restrictions to reduce the unreasonable risk from TCE driven by
inhalation and dermal exposures in the workplace until the prohibition
compliance date and is proposed only for certain conditions of use. EPA
requests public comment related to the ability of regulated entities to
meet the ECEL of 0.0011 ppm, and whether EPA should prescribe mandatory
restrictions and PPE levels.
ii. Existing Chemical Exposure Limit. One requirement considered by
EPA to include in a TCE WCPP to reduce the unreasonable risk driven by
inhalation exposures to TCE for occupational conditions of use was
establishing an ECEL and related implementation measures, such as
exposure monitoring, until the prohibition compliance date. As
described in Unit V.A., the TCE WCPP would be non-prescriptive, in the
sense that regulated entities would not be required to use specific
controls prescribed by EPA to achieve the exposure concentration limit.
Rather, it would be a performance-based exposure limit that would
enable owners or operators to determine how to most effectively put
measures in place to reduce the exposure to TCE based on conditions at
their workplace, consistent with the hierarchy of controls.
A central component of the TCE WCPP is the exposure limit.
Exposures remaining at or below the ECEL would address any unreasonable
risk of injury to health driven by inhalation exposures for
occupational conditions of use. In the case of TCE, EPA has calculated
the ECEL to be 0.0011 parts per million (ppm) (0.0059 mg/m\3\) for
inhalation exposures as an 8-hour TWA in workplace settings, based on
the most sensitive acute non-cancer occupational HEC for fetal cardiac
defects (Ref. 13). The differences between the ECEL and the OSHA PEL
are discussed in more detail in Unit II.C.1.b. EPA chose the acute non-
cancer developmental toxicity endpoint for TCE as the basis for the
exposure limit for the proposed regulatory action as it is the most
sensitive endpoint and, therefore, would be protective of both acute
and chronic non-cancer as well as cancer inhalation endpoints over the
course of a working day and lifetime, including for potentially exposed
or susceptible subpopulations (additional explanation is in Unit
VI.A.). However, as discussed in Unit V.A.2., EPA expects that
detection of and adherence to extremely low-ppm levels of TCE may
present challenges to the regulated community (Ref. 45), and so EPA is
proposing the WCPP until the prohibition compliance date. EPA
emphasizes the time limited nature of this WCPP, due to the likely need
for reliance on air-supplied respirators of APF 1,000 or 10,000 that
would be needed to address the unreasonable risk, even when engineering
and administrative controls are put into place. More details are
provided later in this unit.
iii. Dermal protection. As part of the WCPP, EPA is proposing to
require use and provision of chemically resistant gloves by potentially
exposed persons in combination with specific activity training (e.g.,
appropriate procedures for glove removal, replacement, and disposal)
for tasks where dermal exposure can be expected to occur. However, EPA
understands these tasks are expected to occur for conditions of use,
such as processing TCE as a reactant, where closed system processes are
already in place to minimize exposure to TCE. EPA is not proposing to
require owners or operators to document consideration of the hierarchy
of controls for dermal exposures to TCE because EPA intends to prohibit
all uses of TCE, EPA is proposing relatively rapid compliance dates for
the prohibitions for most uses of TCE, and dermal PPE programs are
somewhat more straightforward to implement than respiratory PPE
programs. In proposing dermal requirements, EPA took into consideration
the volatile nature of TCE because the dermal absorption of TCE depends
on the type and duration of exposure. For the conditions of use that
would be subject to the WCPP, EPA also considered the unique, closed
system processes of each use which aid to reduce dermal exposure.
iv. WCPP considerations. EPA is proposing a WCPP for several
conditions of use of TCE to reduce the unreasonable risk to the extent
possible during the time period before a prohibition becomes effective,
described in Unit V.A.2.
In deciding whether an ECEL and related required measures would
appropriately reduce the unreasonable risk driven by occupational
inhalation exposures, EPA considered factors related to work activities
that may make it difficult to comply with an ECEL, particularly at the
low air concentration level EPA has identified. Once EPA identified the
appropriate risk-based inhalation limit to reduce identified
unreasonable risk, EPA carefully considered the appropriateness of such
an exposure control program for each occupational condition of use of
TCE, in the context of the unreasonable risk. Examples include
conditions of use with work activities that may take place in the
field, making it challenging to establish a regulated area and conduct
monitoring; work activities that may take place in open systems that
require manual contact with the chemical substance; work activities
that may take place in small, enclosed spaces, creating challenges for
implementing engineering controls or using respiratory PPE; work
activities that require a high range of motion or for some other reason
create challenges for the implementation of respiratory PPE; and the
type of PPE that would be needed under the TCE WCPP to meet the ECEL in
the absence of, or in addition to, other feasible exposure controls,
based on analysis in the 2020 Risk Evaluation for TCE describing
expected exposures with and without use of PPE.
EPA also considered the feasibility of exposure reduction
sufficient to reduce the unreasonable risk, including in facilities
currently complying with the OSHA PEL for TCE or implementing other
recommended OELs such as the ACGIH TLV. While EPA acknowledges the
regulated community's expected familiarity with OSHA PELs generally, as
well as facilities' past and ongoing actions to implement the TCE PEL,
the value of EPA's exposure limit is almost five orders of magnitude
lower than the OSHA PEL. (The differences between the ECEL and the OSHA
PEL are discussed in more detail in Unit II.C.4.) This creates a
significant degree of uncertainty as to whether facilities engaging in
most conditions of use could implement engineering or administrative
controls to reduce exposures in a manner aligned with the hierarchy of
controls to meet the ECEL (and associated action level) and whether
they could do so without relying primarily on the use of PPE (which is
the least preferred option in the hierarchy of controls) to supplement
exposure reduction efforts.
EPA understands that this uncertainty extends to the feasibility of
respirators as a long-term risk management practice as well, since the
complexity and burden of wearing respirators increases with increasing
APF. Although respirators, specifically SCBAs (APF 10,000), could
reduce exposures to levels that protect against non-cancer and cancer
risks, not all workers may be able to wear respirators. Individuals
with impaired lung function due to asthma, emphysema, or chronic
obstructive pulmonary disease, for
[[Page 74765]]
example, may be physically unable to wear a respirator. OSHA requires
that a determination regarding the ability to use a respirator be made
by a physician or other licensed health-care professional, and annual
fit testing is required for tight-fitting, full-face piece respirators
to provide the required protection. Individuals with facial hair, such
as beards or sideburns that interfere with a proper face-to-respirator
seal, cannot wear tight fitting respirators. In addition, respirators
may also present communication problems, vision problems, worker
fatigue, and reduced work efficiency (63 FR 1152, January 8, 1998).
According to OSHA, ``improperly selected respirators may afford no
protection at all (for example, use of a dust mask against airborne
vapors), may be so uncomfortable as to be intolerable to the wearer, or
may hinder vision, communication, hearing, or movement and thus pose a
risk to the wearer's safety or health.'' (63 FR 1189 through 1190).
Furthermore, depending on the air concentrations and proximity to the
regulated area, other employees in the area may also need to wear
respiratory PPE. EPA understands, based on reasonably available
information, that occupational exposures tend to fluctuate depending on
the task being performed and the frequency of the task, which could
create challenges for reliably effective implementation of respiratory
PPE (Refs. 70, 72, 35).
EPA reviewed reasonably available information, including monitoring
data, and information related to considerations described previously in
this unit. EPA expects attempts to implement the WCPP to include
increased monitoring and that industry would likely need to exclusively
rely on PPE when aiming to reach the ECEL, including the use of high
APF respirators, such as fit-tested, air-supplied respirators of APF
1,000 or APF 10,000. Given the high APF of respirators that are likely
needed to reach the ECEL, EPA recognizes that this equipment and its
programmatic maintenance could be highly burdensome. EPA believes this
could create implementation challenges and is not a long-term,
sustainable use of the WCPP. The WCPP would be in place for a
relatively short period of time (less than 10 years for the vast
majority of production value) until the eventual prohibition, because
of the likely need for such extensive PPE. The ultimate goal for TCE is
prohibition given the difficulty of maintaining a WCPP long term.
One of the conditions of use for which EPA is proposing a WCPP
until the prohibition goes into effect is processing TCE as a reactant/
intermediate. The majority of the annual production volume of TCE
processed as an intermediate under this condition of use goes almost
entirely toward the manufacture of one HFC, HFC-134a (Refs. 3, 70, 73).
Monitoring information submitted by facilities processing TCE as an
intermediate to manufacture HFC-134a suggests that TCE is largely
confined to the process reactors, which require infrequent loading and
unloading activities taking place approximately 20 times per year and
resulting in low-ppm TCE exposure levels (Ref. 70). The information
submitted also highlights that TCE is consumed and transformed during
the reaction process (Ref. 70). Additionally, HFC-134a is one of the
regulated substances that are subject to a phasedown under the AIM Act,
and as discussed in Unit I.D., EPA understands that HFC-134a has a
lower GWP compared to other refrigerants, which will likely continue to
be used to facilitate the transition from certain other HFCs pursuant
to the phasedown under the AIM Act. Providing a longer phaseout under
TSCA for processing TCE as an intermediate for the manufacture of HFC-
134a, while subject to a WCPP, is consistent with the agency's efforts
to address climate-damaging HFCs, such as HFC-134a, under the AIM Act.
EPA is seeking comment on the actions that manufacturers who process
TCE for the production of HFC-134a would take as a result of this
proposed phaseout and whether this would motivate a decision to cease
manufacture earlier than they would otherwise under the AIM Act phase-
down. For the remaining volume of TCE processed as a reactant/
intermediate for chemical synthesis other than manufacturing HFC-134a,
additional time may be necessary to reconfigure or otherwise adjust the
physical plant to accommodate an alternative manufacturing process, so
a WCPP is also associated with the prohibition of other processing as a
reactant/intermediate uses; however, the phaseout does not apply to the
other uses for which EPA is proposing a more immediate prohibition
discussed in Unit V.A.
Additionally, EPA considered other industrial and commercial uses
as candidates for a WCPP. Similar to the processing of TCE as a
reactant/intermediate, unique, closed-system processes exist for the
industrial and commercial use as: processing aid in process solvent
used in battery manufacture; a process solvent used in polymer fiber
spinning, fluoroelastomer manufacture and Alcantara manufacture; an
extraction solvent used in caprolactam manufacture; and a precipitant
used in beta-cyclodextrin manufacture. Where TCE is used as a
processing aid, TCE is consumed or captured and reused in the process.
Monitoring data suggests low-ppm TCE exposure levels but may involve
daily worker tasks. EPA understands that some of the industrial and
commercial uses of TCE as a processing aid occur outside of the U.S.,
or may no longer be ongoing in the U.S. However, EPA received and
reviewed substantive information from the battery separator
manufacturing industry, specifically for lead-acid and lithium-ion
battery separator manufacturing processes, along with a request for a
TSCA section 6(g) exemption under this TSCA rulemaking. EPA agrees that
battery separator manufacturing is critical to the national economy and
national security; therefore, EPA is proposing to grant a 10-year
exemption from the prohibition for the industrial and commercial use of
TCE as a processing aid for battery separator manufacturing. For this
exemption EPA is proposing to impose the WCPP requirements as a
condition for the TSCA section 6(g) exemption. All other industrial and
commercial processing aid uses (e.g., process solvent used in polymer
fabric spinning, fluoroelastomer manufacture, etc.) must comply with
the more stringent prohibition detailed in Unit V.A.
Furthermore, EPA considered industrial and commercial uses of TCE
as an essential laboratory chemical as necessary to continue following
the WCPP requirements, during the period of the TSCA section 6(g) time-
limited exemption described in Unit V.A. Industrial and commercial use
as a laboratory chemical is necessary to provide for the analysis of
monitoring samples required to implement the ECEL requirements under
the WCPP as part of this proposed regulation, as well as for essential
chemical analysis, including for ongoing cleanup projects that fall
under the Superfund program or other EPA jurisdictions, described in
Unit V.A.3. Furthermore, EPA expects laboratory settings to be more
conducive to the implementation of engineering controls such as fume
hoods to ventilate vapors and reduce overall exposure to TCE in
alignment with the hierarchy of controls.
Lastly, for TCE to be available for the downstream uses described
in this unit, it must be manufactured (including imported), processed,
and distributed in commerce. Therefore, as discussed in Unit V.A., EPA
is proposing the WCPP
[[Page 74766]]
for manufacturing (including importing) and processing for certain
industrial and commercial uses, to allow a continuous supply chain for
the specified conditions of use expected to continue 1 year after the
final rule is published until the prohibition compliance dates.
2. Primary Alternative Regulatory Action
EPA acknowledges that, for some conditions of use that it is
proposing to prohibit, there may be some activities or facilities that
need longer compliance timeframes in order to appropriately transition.
Therefore, the primary alternative regulatory action accounts for
additional time under a prohibition to provide the flexibility for
facilities to comply, for example, to account for issues in the supply
chain, such as the availability of alternatives to reformulate
products. In selecting among the TSCA section 6(a) requirements for the
primary alternative regulatory action for use of TCE-containing
products, EPA considered risk-related factors, including but not
limited to, the population exposed and the severity of the hazard of
TCE and, separately, of other alternative solvents, which are
undergoing risk evaluation and risk management under TSCA section 6,
such as PCE (as part of a separate rulemaking under RIN 2070-AK84). For
example, there may be instances where PCE and TCE may be desired
because they are non-flammable solvents used as cleaning agents for
energized electrical equipment (e.g., circuit boards). In these
instances, additional time may be needed to identify an alternative
chemical or process to avoid flammability concerns.
EPA also considered a TSCA section 6(g) time-limited exemption for
additional conditions of use that are critical or essential, or where a
prohibition could have significant impacts on the national economy,
national security, and infrastructure As described in Unit V.B.3.a.ii.,
EPA requests comments on a TSCA section 6(g) exemption, and based on
the information received may find that an exemption may be warranted
under the primary alternative regulatory action for the industrial and
commercial use of TCE in batch vapor degreasing for critical aerospace
or medical device applications, if the workplaces engaged in that
condition of use cannot meet the requirements of the proposed
regulatory action.
Similar to the proposed regulatory action, the primary alternative
regulatory action would include a WCPP for several conditions of use of
TCE to reduce to the extent possible the unreasonable risk during the
time period before a prohibition becomes effective, including as a
condition to the TSCA section 6(g) exemption, per TSCA section 6(g)(4).
For the implementation of the TCE WCPP, EPA considered providing
additional time under the primary alternative regulatory action for the
WCPP requirements given the difference in order of magnitude for the
exposure limit under TSCA compared to levels required by OSHA or other
recommended guidelines. These provisions would include, for instance,
identifying appropriate monitoring methods to comply with an TSCA
exposure limit that is five orders of magnitude lower than the OSHA PEL
(i.e., 0.0040 ppm vs. 100 ppm, respectively), as well as providing for
respiratory protection corresponding to a higher assigned protection
factor than required by OSHA, further described in Unit II.C.
Further, the WCPP under the primary alternative regulatory action
would include an ECEL of 0.0040 ppm to address inhalation exposures to
TCE in occupational settings that is based on the immunotoxicity
endpoint. EPA believes that this ECEL would be less protective than the
ECEL of 0.0011 ppm based on the developmental toxicity endpoint, that
EPA would require under the proposed regulatory action. (A summary of
EPA's risk evaluation activities under TSCA is provided in Unit II.D.,
and the health effects of TCE, including the difference in the two
human health endpoints as the basis for the two different ECELs, are
discussed in Unit VI.A.) EPA considered the extremely low-ppm values of
both ECELs and acknowledges the uncertainties regarding the ability of
traditional industrial hygiene methods to meet the limit of detection
associated with either ECEL action level, and the feasibility of
combining existing engineering and administrative controls to reduce
the exposure of TCE to extremely low-ppm levels before relying on PPE.
Therefore, EPA does not consider long-term implementation of the WCPP a
feasible means of addressing unreasonable risk indefinitely; as such,
prohibition of the affected conditions of use is ultimately necessary
to address the unreasonable risk under both the proposed and primary
alternative regulatory actions.
The primary alternative regulatory action is described in more
detail in Unit V.B.
3. Risk Management Requirements Considered But Not Proposed
EPA considered but is not proposing to regulate the weight fraction
of TCE in products for industrial and commercial or consumer use
because TCE is the main constituent (e.g., cleaning component) of the
majority of TCE-containing product formulations and EPA understands
that decreasing the concentration of TCE decreases the efficacy of the
product (Refs. 74, 75).
EPA also examined the extent to which a self-certification and
limited-access program restricting TCE use to trained and licensed
users could ensure that only certain workers employed by a facility
would be able to purchase and subsequently use TCE. Under a limited
access program such as a point-of-sale self-certification, entities
would submit a self-certification to the distributor at the point of
purchasing the products. The self-certification could consist of a
statement indicating that the facility is implementing the required
workplace safety measures to control exposures to TCE. However, a
point-of-sale self-certification is not a viable option for this
proposed rulemaking. Given the eventual full prohibition of TCE and the
significant investments users may have to make toward establishing a
WCPP, EPA does not believe it would be practicable to add an additional
burden of implementing a limited access program. Therefore, EPA is not
proposing a self-certification and limited access program as part of
this rulemaking. EPA requests comment on the effectiveness of a limited
access program, such as a point-of-sale self-certification or other
administrative controls, to address the unreasonable risk of TCE, in
particular for facilities with occupational exposures to TCE that may
not be able to meet the WCPP requirements of this proposed rulemaking.
Another option that EPA considered was requiring prescribed
engineering controls, administrative controls, or personal protective
equipment to reduce exposures to TCE in occupational settings.
Prescriptive requirements would be supported by information in the 2020
Risk Evaluation for TCE. However, as described in Unit III.A.1. and 2.,
EPA received input during required consultations and additional
stakeholder engagement that regulatory options that align with the
hierarchy of controls (i.e., elimination and substitution of hazards in
the workplace) should be preferred over prescriptive controls (which
alternatively could be accomplished through the implementation of a
WCPP with a risk-based exposure limit) (Refs. 12, 31). Inadequacy of
engineering, administrative, and personal protective equipment control
measures to lower exposure below the exposure limit
[[Page 74767]]
would mean that elimination or substitution would be the only viable
methods of addressing unreasonable risk. Additionally, the WCPP
approach EPA is considering under the proposed action is a more
flexible approach as prescriptive controls present significant
uncertainties related to their feasibility, given the site-specific
operations and variable configurations, and need for consistency of
proper use.
EPA determined that such controls (i.e., engineering or
administrative controls, or PPE) may not be able to eliminate
unreasonable risk for some conditions of use when used in isolation. In
the 2020 Risk Evaluation for TCE, many conditions of use still drive
unreasonable risk even with the application of air-supplied APF 50
respirators (Ref. 1). Reasonably available data indicated additional
uncertainty regarding the feasibility of exposure reductions through
engineering controls alone, considering the unique closed-system
processes already in place (Refs. 70, 48). For occupational conditions
of use, prohibitions (rather than prescribed controls) would be more
appropriate to ensure the elimination of unreasonable risk of TCE.
Nevertheless, EPA determined that a WCPP, including requirements for an
ECEL (which would be accompanied by monitoring requirements) in tandem
with the implementation of engineering controls, administrative
controls, and/or PPE, as appropriate, would be necessary for reducing
exposures to TCE prior to the proposed prohibition compliance dates.
4. Additional Considerations
After considering the different regulatory options under TSCA
section 6(a), alternatives (described in Unit V.B.), compliance dates,
and other requirements under TSCA section 6(c), EPA developed the
proposed regulatory action described in Unit V.A. to address the
unreasonable risk from TCE so that it is no longer unreasonable. To
ensure successful implementation of this proposed regulatory action,
EPA considered other requirements to support compliance with the
proposed regulations, such as requiring monitoring and recordkeeping to
demonstrate compliance with a WCPP and downstream notification
regarding the prohibition on manufacturing (including import),
processing, and distribution in commerce of TCE, and products
containing TCE, for industrial and commercial use as well as consumer
uses. These proposed requirements are described in Unit V.A.
As required under TSCA section 6(d), any rule under TSCA section
6(a) must specify mandatory compliance dates, which shall be as soon as
practicable with a reasonable transition period, but no later than 5
years after the date of promulgation of the rule (except in the case of
a use exempted under TSCA section 6(g) or for full implementation of
ban or phaseout requirements). These compliance dates are detailed in
Units V.A. and V.B. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.
B. Consideration of Alternatives in Deciding Whether To Prohibit or
Substantially Restrict TCE
Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or
restrict in a manner that substantially prevents a specific condition
of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must consider, to
the extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other
restriction takes effect. To that end, in addition to an Economic
Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using
reasonably available information (Ref. 71).
For this assessment, EPA identified and analyzed alternatives to
TCE in products relevant to industrial, commercial, and consumer
conditions of use proposed to be prohibited or restricted. Based on
reasonably available information, including information submitted by
industry, EPA understands viable alternatives to TCE may not be
available for several conditions of use, for example, processing TCE as
an intermediate for the manufacture of HFC-134a, and considered that
information to the extent practicable in the development of the
regulatory options as described in Unit III.B.3. For some conditions of
use, EPA was unable to identify products currently available for sale
that contain TCE. EPA is soliciting comments on whether there are
products in use or available for sale relevant to these conditions of
use that contain TCE at this time, so that EPA can ascertain whether
there are alternatives that benefit human health or the environment as
compared to such use of TCE. These conditions of use are detailed in
the Alternatives Assessment (Ref. 71).
For conditions of use for which products currently containing TCE
were identified, EPA identified several hundred commercially available
alternative products that do not contain TCE, and listed in the
Alternatives Assessment, to the extent practicable, their unique
chemical components, or ingredients. For each of these chemical
components or ingredients, EPA identified whether it functionally
replaced TCE for the product use and screened product ingredients for
human health and environmental hazard, as well as identified
flammability and global warming potential where information was
reasonably available (Ref. 71). EPA then assigned a rating to the human
health and environmental hazards, using a methodology described in the
Alternatives Assessment document. In general, EPA identified products
containing ingredients with a lower hazard screening rating than TCE
for certain endpoints, while some ingredients presented higher hazard
screening ratings than TCE (Ref. 71). These alternative hazard
screening ratings are described in detail in the Alternatives
Assessment grouped under common product use categories (Ref. 71).
Discussion of alternatives to TCE was discussed during the SBAR
Panel process outreach meetings. EPA's consideration of alternatives
was informed by the information provided by SERs, which included known
problems and risks with several available alternatives, such as
flammability, toxicity, and water limitations due to drought.
Specifically, SERs discussed how some chlorinated solvents are
currently undergoing TSCA risk evaluations, while other alternatives
may be labeled as severe fire hazards by the National Fire Protection
Association. SERs also mentioned that in the automotive and aerospace
industries, alternative solvent degreasers may have their own hazard
profile, which can include flammability, lower boiling temperatures,
and toxicity (Ref. 32). SERs expressed concern for future regulation of
chemicals undergoing risk evaluation, and also described the challenges
of alternative processes, such as aqueous methods. Specifically, SERs
described how in certain regions it is difficult to justify
installation of these systems due to limited space or water
availability. One SER provided an account about one of their customers,
who had an aqueous cleaning system installed and was unable to source
the required amount of water to run it. EPA notes the concerns
expressed by SERs regarding availability of feasible alternatives that
could be subject to market forces that may impact availability of
alternatives (e.g., certain fluorinated chemicals) or potentially be
[[Page 74768]]
subject to future EPA regulations. EPA notes that SERs described how
available alternatives for lubricants in spray applications are mostly
fluorinated organic compounds; although non-fluorinated options may
exist, the SERs expressed concern for future potential regulatory
activity. A trade organization SER highlighted that some fluorinated
alternatives to TCE are under increased regulatory scrutiny, especially
at state levels, because they may be subject to state PFAS laws based
on their chemical structure and properties (Ref. 32). These discussions
with SERs informed the Panel recommendations.
EPA has considered input from SERs and other stakeholders regarding
alternatives to TCE, as well as the information used for the
Alternatives Assessment. In deciding whether to propose prohibition or
other significant restrictions on a condition of use of TCE and in
proposing an appropriate transition period for any such action, EPA has
therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the
extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use proposed to be prohibited or restricted, would be reasonably
available as a substitute when a proposed prohibition or other
significant restriction would become effective. EPA is additionally
requesting comment on the Alternatives Assessment as a whole.
VII. TSCA Section 6(c)(2) Considerations: Magnitude of Human Exposure,
Environmental Effects of TCE, Benefits of TCE for Various Uses, and
Reasonably Ascertainable Economic Consequences
As described in Unit IV., TSCA section 6(a) rules must be
promulgated ``in accordance with subsection (c)(2).'' TSCA section
6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section
6(a) rules, to ``consider and publish a statement based on reasonably
available information'' with respect to listed criteria, including the
effects and magnitude of exposure to human health and the environment,
the benefits of the chemical substance for various uses, and the
reasonably ascertainable economic consequences of the rule. Under TSCA
section 6(c)(2)(B), EPA must ``factor in, to the extent practicable,''
the considerations under TSCA section 6(c)(2)(A) when selecting among
prohibitions and other restrictions in TSCA section 6(a) rules. EPA's
consideration of the health effects of TCE is in Unit IV.; EPA's
consideration of the remaining considerations under TSCA section
6(c)(2) are in this unit.
A. Magnitude of Human Exposure to TCE
TSCA section 6(c)(2)(B) directs EPA to factor in, to the extent
practicable, the magnitude of human exposure to TCE under TSCA section
6(c)(2)(A). EPA's analysis of the magnitude of human exposure to TCE
are in the 2020 Risk Evaluation for TCE (Ref. 1). A summary is
presented here.
Regarding the magnitude of human exposure, one factor EPA considers
for the conditions of use that drive unreasonable risk is the size of
the exposed population which, for TCE, EPA estimates is 43,675 workers,
8,920 ONUs, and 20,600 consumers (Ref. 3).
For the conditions of use that drive the unreasonable risk for TCE,
PESS include workers and occupational non-users (ONUs), including men
and women of reproductive age, adolescents, and biologically
susceptible subpopulations; and consumer users (age 11 and older) and
bystanders (of any age group, including infants, toddlers, children,
and elderly), including biologically susceptible subpopulations.
In addition to workers, ONUs, consumers, and bystanders to consumer
use directly exposed to TCE, EPA recognizes there is exposure to the
general population from air and water pathways for TCE. As mentioned in
Unit II.D., EPA has separately conducted a screening approach to assess
whether there may be potential risks to the general population from
these exposure pathways. The screening approach was developed in order
to allow EPA to determine--with confidence--situations which present no
unreasonable risk to fenceline communities or where further
investigation would be needed to develop a more-refined estimate of
risk. The fenceline technical support memos for the ambient air pathway
and the water pathway provide the Agency with a quantitative assessment
of exposure. For TCE, the results from applying this screening approach
did not allow EPA to rule out unreasonable risk to fenceline
communities. This unit summarizes the results of that fenceline
analysis. Although EPA is not making a determination of unreasonable
risk based on the fenceline screening analysis, the proposed regulatory
action described in Unit V.--which would ultimately prohibit all
conditions of use of TCE is expected to eliminate the risks identified
in the screening approach.
As described in Unit II.D., EPA's analysis methodology was
presented to the SACC peer review panel in March 2022, and EPA
considered SACC feedback (including the SACC recommendation to EPA to
consider multiple years of release data to estimate exposures and
associated risks) when applying the fenceline analysis to TCE. EPA also
plans to consider SACC feedback and make decisions regarding how to
build upon the screening approach so that EPA can more accurately
assess and quantify general population exposures in upcoming risk
evaluations, such as for the 1,4-dioxane supplement, the forthcoming 20
High Priority Substances, and manufacturer-requested risk evaluations.
For TCE, EPA is including a multi-year assessment of the ambient air
pathway in light of peer review comments on the initial methodology.
EPA interpreted risk estimates in relation to the benchmark values
corresponding to each hazard value. In the case of acute and chronic
exposures to drinking water, as well as incidental oral and incidental
dermal exposures in ambient waters, potential for noncancer risk was
identified by those risk estimates below the benchmark MOE for acute
and chronic non-cancer immunotoxicity and developmental endpoints.
While cancer risks were not assessed for incidental oral or dermal
exposure pathways, cancer risks were assessed for inhalation exposures.
For cancer, potential for risk was identified by those risk estimates
above the benchmark. For the air pathway, EPA's analysis identified
risk estimates that did not exceed the benchmarks for at least two non-
cancer endpoints (developmental and immunotoxicity), and risk estimates
above the benchmark for cancer. Estimates of cancer risk to fenceline
communities were calculated and compared to 1 x 10-6 as a
benchmark value for cancer risk in fenceline communities. Cancer
benchmarks used by EPA and other regulatory agencies in interpreting
the significance of cancer risks range from 1 in 1,000,000 to 1 in
10,000 (i.e., 1 x 10-6 to 1 x 10-4) depending on
the subpopulation exposed (see, e.g., EPA's interpretation set forth in
the Federal Register of September 14, 1989 (54 FR 38044) which
discusses the use of benchmarks for purposes of assessing exposures to
individuals living in the vicinity of air emissions sources under
section 112 of the Clean Air Act (CAA); see also EPA's interpretation
of the upper bound of acceptable risk and the preferred benchmark
described in the Letter of Concern regarding EPA Complaint Nos. 01R-22-
R6, 02R-22-R6, and 04R-22-R6 (Ref. 76, see page 3
[[Page 74769]]
footnotes 5 and 6, and page 6)). While EPA is unable to formally
determine, based on the screening level fenceline analysis, whether
risks to the general population drive the unreasonable risk, as a
matter of risk management policy EPA considers the range of 1 in
1,000,000 to 1 in 10,000 (i.e., 1 x 10-6 to 1 x
10-4) as the appropriate values for interpreting the
significance of increased cancer risk for the general population,
including fenceline communities. It is preferable to have the air or
water concentrations of TCE result in an increased cancer risk closer
to the 1 in 1,000,000 (1 x 10-6) value, with the 1 in 10,000
(1 x 10-4) value generally representing the upper bound of
acceptability for estimated excess cancer risk. Benchmark values help
inform decisions regarding the significance of risk, and the Agency
considers a number of other factors when determining whether risks are
significant, such as the endpoint under consideration, the
reversibility of effect, and exposure-related considerations (e.g.,
duration, magnitude, or frequency of exposure, or population exposed).
In this unit, EPA presents the results of its ambient air and water
pathways fenceline analysis and the uncertainties associated with the
analysis. Overall, EPA's fenceline analysis for the air and water
pathways for TCE did not allow EPA to rule out unreasonable risk to
fenceline communities with confidence. Additionally, based on the
fenceline analysis for the ambient air and water pathways for TCE,
including the strengths, limitations, and uncertainties associated with
the information used to inform the analysis, EPA is unable to determine
with this analysis whether those risks drive the unreasonable risk of
injury to health presented by TCE. EPA also describes how the proposal
to prohibit the manufacturing (include importing), processing, and
distribution in commerce of TCE for all uses of TCE (including all
consumer use) is expected to eliminate the potential risks identified
in the screening analysis to any general population or fenceline
communities close to facilities engaging in TCE use. This unit also
describes how EPA believes the proposed WCPP requirements may reduce
exposures to the general population for facilities identified in the
fenceline analysis with expected exposures to fenceline communities
that are associated with conditions of use for which EPA is proposing
longer compliance timeframes (including under a TSCA section 6(g) time-
limited exemption). EPA therefore does not intend to revisit the air or
water pathways for TCE as part of a supplemental risk evaluation.
1. Ambient Air Pathway Analysis
The ambient air fenceline analysis was divided into three
components: (1) A single-year ambient air analysis, (2) A multi-year
ambient air analysis, and (3) A land use analysis. EPA conducted an
ambient air analysis for a single year and multiple years to assess
where estimates exceeded the one in a million risk estimates for non-
cancer and cancer risk for real and generic, or modeled, facilities at
multiple distances. After doing an initial screen (the single year
ambient air screening analysis) that did not rule out unreasonable
risk, EPA conducted additional analyses (the multi-year ambient air
analysis) from which it derived risk estimates that, with a small
number of exceptions, are within the cancer benchmarks used by EPA and
other regulatory agencies of 1 in 10,000 to 1 in 1,000,000. The single
year ambient air screening analysis and the multi-year ambient air
analysis allow EPA to mathematically calculate a cancer risk in
fenceline communities. The Agency then conducted a land use analysis as
part of both the single-year and multi-year analyses to determine if
EPA could reasonably expect an exposure to fenceline communities to
occur within the modeled distances for facilities where there was an
indication of risk. This review consisted of a visual analysis using
aerial imagery and interpreting land/use zoning practices around each
facility to identify where residential, industrial/commercial
businesses, or other public spaces are present within those radial
distances indicating risk (as opposed to uninhabited areas), as well as
whether the radial distances lie outside the boundaries of the
facility.
There are some uncertainties associated with the fenceline analysis
for the air pathway for TCE. The TRI dataset used for the single- and
the multi-year fenceline analysis and land use analysis does not
include actual release point locations, which can affect the estimated
concentrations at varying distances modeled. To identify the release
location for each facility, EPA used a local-coordinate system based on
latitude/longitude coordinates reported in TRI. The latitude/longitude
coordinates may represent the mailing address location of the office
building associated with a very large facility or some other area of
the facility rather than the actual release location (e.g., a specific
process stack). This discrepancy between the coordinates reported in
TRI and the actual release point could result in an exposure
concentration that does not represent the actual distance where
fenceline communities may be exposed. The fenceline analysis also
evaluated the most ``conservative exposure scenario'' that consists of
a facility that operates year-round (365 days per year, 24 hours per
day, 7 days per week) in a South Coastal meteorologic region and a
rural topography setting (Ref. 77). Therefore, the modeled exposures to
people who live in fenceline communities may be overestimated if there
are fewer exposure days per year or hours per day.
Additionally, the ambient air fenceline analysis (as well as the
water pathway analysis, described in Unit VII.A.2.) organizes
facilities and associated risks by OES and generally crosswalks each
OES with the associated condition of use of TCE (Ref. 77). For some
OES, EPA identified the associated conditions of use to the category
level in the November 2020 Risk Evaluation for TCE, but, for the air
pathway, was unable to identify the conditions of use to the
subcategory level due to limited information on activities and use of
TCE reported under TRI. Therefore, some OES indicating increased risk
from ambient air exposures to TCE in the air fenceline analysis may be
associated with one or more conditions of use of TCE.
EPA's analysis included inhalation hazard values for cancer and
non-cancer risk (acute and chronic immunological and developmental
endpoints). Because risk estimates did not exceed the benchmarks for
any risks of non-cancer effects, the results presented focus on cancer
risks. EPA's single year fenceline analysis for the ambient air
pathway, based on methods presented to the SACC, evaluated TCE releases
reported to TRI over the 2019 reporting year. This single-year
fenceline analysis identified risk estimates exceeding one in a million
for cancer risk for 99 of the 133 facilities (including generic, or
modeled, facilities) at multiple distances, representing 13 OES. While
the analysis identified facilities with some indication of releases and
potential exposure with associated increased cancer risk that exceeds
one in a million at a distance of 100 meters or more from the releasing
facility, the analysis did not identify any facilities exceeding 1 in
10,000; the highest risk estimate is in the 1 in 100,000 range.
Separately, following SACC feedback, EPA applied a slightly modified
pre-screening methodology to evaluate 6 years of TCE release data (2015
through 2020 TRI data as well as the 6-year average of that data)
rather than a single year of data for facilities with reported releases
in TRI. Although the multi-year analysis
[[Page 74770]]
identified several additional facilities with risk estimates above one
in a million for cancer farther out when compared to the single year
analysis or that were not captured in the single-year analysis, the
results of the overall risk profiles (i.e., OES and corresponding
conditions of use with risk estimates above one in a million for cancer
at the distances evaluated) indicated a higher risk profile than the
single year analysis: the multi-year analysis identified 217 facilities
and found risk estimates above one in a million for cancer in 133 of
those facilities at a distance of 100 meters from the releasing
facility. Based on the multi-year analysis, 58 of these 133 facilities
either had risks above one in a million for cancer at distances farther
out than 100 meters when compared to the single year analysis or are
facilities that were not captured in the single-year analysis (e.g.,
did not report in 2019 TRI). The analysis did not identify any
facilities exceeding 1 in 10,000 at a distance greater than 100 meters;
the highest risk estimate is in the 1 in 100,000 range (Ref. 77).
EPA conducted a land use analysis to determine if EPA can
reasonably expect an exposure to fenceline communities to occur within
the modeled distances for facilities where there was an indication of
risk in the single year or multi-year fenceline analysis. This review
consisted of a visual analysis using aerial imagery and interpreting
land/use zoning practices around the facility to identify where
residential, industrial/commercial businesses, or other public spaces
are present within those radial distances indicating risk (as opposed
to uninhabited areas), as well as whether the radial distances lie
outside the boundaries of the facility. The land use analysis of the 85
facilities with risk indicating risk in the single-year fenceline
analysis identified 69 facilities with expected exposure to fenceline
communities. The land use analysis of the 58 facilities indicating risk
in the multi-year fenceline analysis (i.e., facilities where risk
estimates were above one in a million for cancer at distances farther
out when compared to the single-year analysis or facilities that were
not captured in the single year analysis) identified a total of 55
facilities with expected exposure to fenceline communities. Those
facilities represent 10 OES and include: degreasing (batch open-top
degreasing; batch closed-loop degreasing; conveyorized vapor
degreasing; web vapor degreasing; cold cleaning); formulation of
aerosol and non-aerosol products; industrial processing aid;
manufacturing; metalworking fluids; other industrial uses; process
solvent recycling and worker handling of wastes; processing as a
reactant; recycling and disposal; and repackaging (Ref. 77).
Under the proposed regulatory action described in Unit V.A., each
of the conditions of use that indicate risk relative to the one in a
million cancer risk estimate would ultimately be prohibited, many of
them within one year. As a result, exposures to any fenceline
communities from these facilities would be eliminated under the
prohibitions in this proposed rulemaking. The risks to fenceline
communities from exposure further strengthens the impetus for EPA's
prohibition of TCE.
EPA recognizes that there are some facilities for which risks are
indicated that may exceed the one in a million risk estimate and with
expected exposure to fenceline communities that may be associated with
the following conditions of use that EPA is proposing to prohibit under
longer compliance timeframes: degreasing (batch open-top degreasing;
batch closed-loop degreasing; conveyorized vapor degreasing; web vapor
degreasing; cold cleaning); industrial processing aid; manufacturing;
and processing as a reactant. For processing as a reactant, EPA notes
that while the analysis identified facilities with some indication of
releases and potential exposure with associated increased cancer risk
that exceeds one in a million at a distance of 100 meters from the
releasing facility, the analysis did not identify any facilities
exceeding 1 in 10,000; the highest risk estimate is in the 1 in 100,000
range. For this and other conditions of use that may be associated with
facilities that indicate risks with expected exposure to fenceline
communities, the proposed rule would require strict workplace exposure
controls via implementation of a WCPP as described in Unit V.A.2.,
until the prohibition compliance date. Under the proposed WCPP
requirements, facilities would need to monitor indoor TCE air
concentrations, which would allow facilities to better understand and
manage the total releases of TCE. Furthermore, under the WCPP
requirements, facilities would need to evaluate controls to determine
how to reduce releases and exposures to potentially exposed persons in
the workplace. EPA anticipates that this analysis would help facilities
to determine the most effective ways to reduce exposures (including
possible engineering controls or elimination/substitution of TCE) and
whether those methods for exposure reduction impact releases, and
therefore may reduce the overall risk to fenceline communities from
facilities permitted to use TCE under a longer compliance timeframe
until the prohibition compliance date. As further detailed in Unit
V.A.2.b.iii., EPA is also requesting comment on whether industry
anticipates increased releases of TCE to outdoor air associated with
the implementation of the WCPP. In order to avoid unintended increases
in exposures to people from TCE emissions to ambient air, EPA requests
comment on whether owners and operators should be required to attest in
their exposure control plan that engineering controls selected do not
increase emissions of TCE to ambient air outside of the workplace and
document in their exposure control plan whether additional equipment
was installed to capture emissions of TCE to ambient air. EPA requests
comment on how such a requirement could impact the availability,
feasibility, or cost of engineering controls as a means to reduce
workplace exposures to or below the proposed ECEL. EPA is also
soliciting comment on the frequency and nature of air monitoring EPA
should consider including as requirements in the final rule.
In the instances where efforts to reduce exposures in the workplace
to levels below the ECEL could lead to adoption of engineering controls
that ventilate more TCE outside, EPA believes this potential exposure
would be limited as a result of the existing NESHAP for TCE for these
conditions of use under the CAA. Applicable NESHAP include: 40 CFR part
63, subpart F, Synthetic Organic Chemical Manufacturing Industry; 40
CFR part 63, subpart DD, Off-Site Waste and Recovery Operations; 40 CFR
part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part 63,
subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part 63,
subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR part
63, subpart T, Halogenated Solvent Cleaning, which impose emission
standards and work practice requirements reflecting maximum achievable
control technology and generally available control technology. The CAA
required residual risk reviews for standards reflecting maximum
achievable control technology, and technology reviews are required
every 8 years for all NESHAP.
2. Water Pathway Analysis
The methods used to assess the water pathways (i.e., drinking water
or incidental dermal or oral exposure in ambient waters) for TCE are
consistent
[[Page 74771]]
with the methods described in the 2022 Fenceline report that underwent
peer review (Ref. 78). Briefly, EPA assessed exposure via drinking
water, incidental oral ingestion, and incidental dermal contact based
on modeled stream and water body concentrations, using information
described and documented in the November 2020 TCE Risk Evaluation (Ref.
1). This included the amount of chemical released to wastewater, the
release days per year (with a high end of 250 to 365 days per year, and
a low end of 20 days per year), the percent removal from wastewater
treatment, and site-specific stream flow or dilution factors.
There are some uncertainties associated with the fenceline analysis
for the water pathway for TCE. For the ambient water pathway, exposures
were evaluated based on modeled stream and water body concentrations
using E-FAST 2014, which is subject to a number of uncertainties. For
example, stream flow data available in the E-FAST 2014 at the time of
this analysis were 15 to 30 years old and therefore may not represent
current conditions at a particular location. Additionally, E-FAST 2014
estimates waterbody surface water concentrations at the point of
release without considering certain post-release environmental fate of
degradation processes, which may lead to higher predicted surface water
concentrations. Similarly, estimated drinking water exposures are based
on assumptions that an individual is exposed to potential waterbody
concentrations at the point of release without any potential for
transport, dilution, or treatment and therefore represent higher-end
estimates of possible drinking water exposures (Ref. 79). An additional
uncertainty relates to the crosswalk of a given facility to a
particular OES and then condition of use; as described in Unit
VII.A.2., due to limited information on activities and use of TCE in
the data sources available, there is uncertainty if the facilities
associated with a specific OES were correctly cross-walked to the
appropriate condition of use, or whether some OESs indicating increased
risk from water exposures to TCE should be associated with more than
one condition of use.
EPA's screening level analysis for the water pathway for TCE, based
on methods presented to the SACC, found potential risks from several
OES from exposure to drinking water, incidental dermal or incidental
oral exposure in ambient waters. The estimated exposure values for the
screening level assessed water pathway resulted in estimated acute
noncancer, chronic noncancer, or cancer risk for relative to their
respective benchmark values for various evaluated OESs (Ref. 79).
The drinking water analysis modeled a total of 101 releases across
all OES for the 20-day release scenario, and modeled a total of 103
releases for the maximum days of release scenario. For the drinking
water exposure, risks relative to the benchmark for the acute non-
cancer developmental endpoint for both the 20-day and maximum days of
release scenarios for at least one facility in each of the following
OES: Manufacturing; Processing as a Reactant; Degreasing; Repackaging;
Process Solvent Recycling; Adhesives, Sealants, Paints and Coatings;
Industrial Processing Aid, and Other Industrial Uses. For drinking
water exposures, at least one facility indicated an increased cancer
risk at or above 1 in 1,000,0000 (but less than 1 in 100,000) for both
the 20-day and maximum days of release scenarios for the Degreasing and
Repackaging OES. EPA did not identify source water drinking water
intakes for public drinking water systems within 10 miles downstream of
facilities with known locations discharging to identifiable
waterbodies. No risks relative to acute or chronic exposures for the
immune endpoint or for chronic exposures for the developmental endpoint
benchmarks were identified for any OES for drinking water exposures;
for the immune endpoint, estimated margins of exposure were at least 4-
fold higher than benchmarks.
For the incidental oral exposure in ambient water, a total of 113
releases were modeled across all OES for the 20-day release scenario,
and a total of 115 releases were modeled across all OES for the maximum
days of release scenario. Risks relative to the benchmark were
identified for at least one facility for the acute non-cancer
developmental endpoint under the 20-day scenarios for Processing as a
Reactant; Degreasing; Repackaging; Process Solvent Recycling;
Adhesives, Sealants, Paints, and Coatings; and Other Industrial Uses
OESs were identified for the 20-days of release scenario. For the
maximum days of release scenario, risks relative to the benchmark for
the acute developmental endpoint were identified for: Processing as a
Reactant and Degreasing. For the immune endpoint, no risks were
identified relative to the acute exposures benchmark. For chronic
scenarios, risk was identified relative to the benchmarks for both the
immune and developmental endpoints for the 20-day and maximum days of
release scenarios. Specifically, at least one facility in the
Degreasing OES was identified as showing risk relative to both
endpoints for the maximum risk scenarios for both types of releases
(20-day and maximum), and at least one facility in the Processing as a
Reactant OES was identified as showing risk relative to the
developmental endpoint for both the 20-day and maximum release
scenarios.
Similarly, for the incidental dermal exposure in ambient waters
pathway, a total of 113 releases were modeled across all OES for the
20-day release scenario, and a total of 115 releases were modeled
across all OES for the maximum days of release scenario. For both
incidental oral and incidental dermal exposures, EPA did not assess
cancer risk because repeated exposures are not expected to continue
across a lifetime. For acute scenarios, risk was identified for at
least one facility relative to both the immune and developmental
endpoints for the 20-day and maximum release scenarios. For 20-day
release scenarios, the immune endpoint had identified risk relative to
the benchmark for at least one facility in the Degreasing OES, while
the developmental endpoint had identified risk relative to the
benchmark for the at least one facility in the following OES:
Processing as a Reactant; Degreasing; Repackaging; Process Solvent
Recycling; Adhesives, Sealants, Paints, and Coatings; Industrial
Processing Aid; and Other Industrial Uses. For the maximum days of
release scenarios, risk relative to the developmental endpoint was
identified for at least one facility in the Processing as a Reactant
and the Degreasing OES. For chronic scenarios, risk was identified
relative to both the immune and developmental endpoint benchmarks for
at least one facility for both the 20-day and maximum days of release
scenarios. For 20-day release scenarios, the Processing as a Reactant
and Degreasing OES had risks identified relative to the immune and
developmental endpoint benchmarks; for the maximum days release
scenarios, the Processing as a Reactant and Degreasing OES had risks
identified relative to the immune and developmental endpoint
benchmarks.
Overall, for the analysis of the water pathway, EPA identified
potential risks that exceed the benchmark for non-cancer endpoints from
several facilities, representing benchmark exceedances between 1 and 10
OES, depending on whether the drinking water, incidental oral, or
incidental dermal exposures are considered. In each case for the
screening level analysis, risks were identified only for the maximum
risk scenarios (or facilities with the highest reported results), and
for a relatively
[[Page 74772]]
small number of facilities. In instances where a facility may be
engaging in a condition of use with a longer phase-out, EPA notes that
in no instances did EPA identify drinking water intakes within 10 miles
of a discharging facility, and emphasizes that the scenarios analyzed
include significant uncertainties and assumptions within the high-end
risk estimates due to reliance on the highest-reported results from
several facilities (Ref. 79). Regarding cancer risks, while the
analysis identified facilities with some indication of releases and
potential drinking water exposure with associated increased cancer risk
that exceeds more than 1 in 1,000,000, the analysis did not identify
any facilities exceeding more than 1 in 10,000; the highest potential
risk estimate is in the 1 in 100,000 range (Ref. 79).
Under the proposed regulatory action described in Unit V.A., all
conditions of use would ultimately be prohibited and so any potential
risk indicated by this screening analysis would be eliminated. In
particular, under the proposed regulatory action the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works would be prohibited. The risks to fenceline communities
from exposure through water further strengthen the impetus for EPA's
prohibition of TCE. EPA therefore does not intend to revisit the water
pathway for TCE as part of a supplemental risk evaluation.
B. Environmental Effects of TCE and the Magnitude of Exposure of the
Environment to TCE
EPA's analysis of the environmental effects of TCE and the
magnitude of exposure of the environment to TCE are in the 2020 Risk
Evaluation for TCE (Ref. 1). The unreasonable risk determination for
TCE is based solely on risks to human health (Ref. 2); based on the
TSCA 2020 Risk Evaluation for TCE, EPA determined that exposures to the
environment did not drive the unreasonable risk. A summary is presented
here.
For all conditions of use, amphibian, fish, and aquatic
invertebrate acute and chronic exposures to TCE do not drive the
unreasonable risk. To characterize the exposure to TCE by aquatic
organisms, EPA assessed environmental exposures derived from predicted
and measured concentrations of TCE in surface water in the U.S.
Specifically, the aquatic exposures associated with the industrial and
commercial conditions of use were predicted through modeling, and the
aquatic exposure assessment also includes an analysis of collected
measured surface water concentrations from monitoring data. EPA
considered the biological relevance of the species to determine the
concentrations of concern for the location of surface water
concentration data to produce risk quotients, as well as frequency and
duration of the exposure. EPA determined that the evaluation does not
support an unreasonable risk determination to aquatic organisms.
The toxicity of TCE to sediment-dwelling invertebrates is similar
to the toxicity to aquatic invertebrates. TCE is expected to remain in
aqueous phases and not adsorb to sediment due to its water solubility
and low partitioning to organic matter. TCE has relatively low
partitioning to organic matter and biodegrades slowly, so TCE
concentrations in sediment pore water are expected to be similar to the
concentrations in the overlying water or lower in the deeper part of
sediment where anaerobic condition prevails. Thus, the TCE detected in
sediments is likely from the pore water. Therefore, for sediment-
dwelling organisms, the risk estimates, based on the highest ambient
surface water concentration, do not support an unreasonable risk
determination to sediment-dwelling organisms from acute or chronic
exposures.
For terrestrial organisms, TCE exposure is expected to be low since
physical-chemical properties do not support an exposure pathway through
water and soil pathways to these organisms. Therefore, for terrestrial
organisms, the risk estimates, based on the EPA 2003 Guidance for
Ecological Soil Screening Levels, do not support an unreasonable risk
determination from acute or chronic exposures.
C. Benefits of TCE for Various Uses
TCE has a wide range of uses, including as an intermediate during
the manufacture of refrigerants, specifically HFC-134a, and is also
used as a solvent, frequently in cleaning and degreasing (including
spot cleaning, vapor degreasing, cold cleaning, and aerosol
degreasing). A variety of consumer and commercial products use TCE as
adhesives and sealants, in paints and coatings, and in other
miscellaneous products. TCE is subject to Federal and State regulations
and reporting requirements.
The largest uses of TCE, by production volume, are for processing
as a reactant/intermediate as well as aerosol and vapor degreasing
uses. Based on the 2020 Risk Evaluation for TCE, over 84% of the
production volume of TCE is processed as a reactant/intermediate, the
majority of the volume is for TCE processed as an intermediate in the
production of HFC-134a, a refrigerant widely used in a broad range of
applications. The second largest use of TCE is in industrial and
commercial uses for aerosol and vapor degreasing. TCE is a relatively
inexpensive solvent useful for cleaning contaminated metal parts and
other fabricated materials (Ref. 3).
TCE has many other uses, which, based on the 2020 Risk Evaluation
for TCE, collectively constitute about 1% of the production volume
(Ref. 1). In battery separator manufacturing, TCE is used as an
extraction solvent to produce the desired porosity in lead-acid and
lithium battery separators, which are essential to power vehicles and
systems in the U.S. supply chain.
D. Reasonably Ascertainable Economic Consequences of the Proposed Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
The reasonably ascertainable economic consequences of this proposed
rule include several components, all of which are described in the
Economic Analysis for this proposed rule (Ref. 3). With respect to the
anticipated effects of this proposed rule on the national economy, EPA
considered the number of businesses and workers that would be affected
and the costs and benefits to those businesses and workers and did not
find that there would be an impact on the national economy (Ref. 3).
The economic impact of a regulation on the national economy becomes
measurable only if the economic impact of the regulation reaches 0.25%
to 0.5% of Gross Domestic Product (GDP) (Ref. 80). Given the current
(real) GDP [of $60.4 trillion (2022)], this is equivalent to a cost of
$151 billion to $302 billion. Therefore, because EPA has estimated that
the monetized cost of the proposed rule would range from $33.1 million
annualized over 20 years at a 3% discount rate and $40.6 million
annualized over 20 years at a 7% discount rate, EPA has concluded that
this action is highly unlikely to have any measurable effect on the
national economy (Ref. 3). EPA does not have data to quantify
employment impacts of the proposed rule, and large employment impacts
are not expected. Instead, workers currently using TCE are expected to
continue employment while shifting away from TCE use and towards
alternatives. However, EPA acknowledges that transitional employment
impacts may be
[[Page 74773]]
experienced by some workers at facilities that opt to close or shift
operations abroad instead of complying with requirements at the
facilities currently using TCE. EPA considered the employment impacts
of this proposed rule, and found that the direction of change in
employment is uncertain, but EPA expects the short-term and longer-term
employment effects to be small.
Of the small businesses potentially impacted by this proposed rule,
99.1% are expected to have impacts of less than 1% to their firm
revenues, 0.5% are expected to have impacts between 1 and 3% to their
firm revenues, and 0.4% are expected to have impacts greater than 3% to
their firm revenues. The largest segment of businesses that would be
affected by this regulation are commercial users of liquid and aerosol
degreasers. Costs of alternatives were found to be both higher and
lower than products containing TCE. For most product types,
alternatives with similar efficacy are available with costs that both
lower and higher than TCE products. However, there may be some
applications where TCE is more effective, reducing labor time and wait
time, and or where extensive safety testing might be required. EPA was
unable to quantify these costs.
With respect to this proposed rule's effect on technological
innovation, EPA expects this action to spur more innovation than it
will hinder. A prohibition or significant restriction on the
manufacture, processing, and distribution in commerce of TCE for uses
covered in this proposed rule may increase demand for safer chemical
substitutes. This proposed rule is not likely to have significant
effects on the environment because TCE does not present an unreasonable
risk to the environment, though this proposed rule does present the
potential for small reductions in air emissions and soil contamination
associated with improper disposal of products containing TCE. The
effects of this proposed rule on public health are estimated to be
positive, due to the reduced risk of cancer and other non-cancer
endpoints from exposure to TCE.
2. Costs and Benefits of the Proposed Regulatory Action and of the One
or More Primary Alternative Regulatory Actions Considered by the
Administrator
The costs and benefits that can be monetized for this proposed rule
are described at length in in the Economic Analysis (Ref. 3). The
monetized costs for this proposed rule are estimated to range from
$33.1 million annualized over 20 years at a 3% discount rate and $40.6
million annualized over 20 years at a 7% discount rate. The monetized
benefits are estimated to range from $18.1 to $21.5 million annualized
over 20 years at a 3% discount rate and $8.2 to $10.3 million
annualized over 20 years at a 7% discount rate.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary alternative regulatory action is described in detail in Unit
V.B. The estimated annualized costs of the alternative regulatory
action are $34.4 million at a 3% discount rate and $41.2 million at a
7% discount rate over 20 years (Ref. 3). The monetized benefits of this
alternative regulatory action are estimated to range from $18.1 to
$21.5 million annualized over 20 years at a 3% discount rate and $8.2
to $10.3 million annualized over 20 years at a 7% discount rate over 20
years (Ref. 3).
This proposal is expected to achieve health benefits for the
American public, some of which can be monetized and others that, while
tangible and significant, cannot be monetized. EPA believes that the
balance of costs and benefits of this proposal cannot be fairly
described without considering the additional, non-monetized benefits of
mitigating the non-cancer adverse effects. These effects may include
neurotoxicity, kidney toxicity, liver toxicity, immunological and
hematological effects, reproductive effects, and developmental effects.
The multitude of adverse effects from TCE exposure can profoundly
impact an individual's quality of life, as discussed in Unit II.A.
(overview), Unit III.B.2. (description of the unreasonable risk), Unit
V.A. (discussion of the health effects), and the 2020 Risk Evaluation
for TCE. Chronic adverse effects of TCE exposure include both cancer
and the non-cancer effects listed in this paragraph. Acute effects of
TCE exposure could be experienced for a shorter portion of life but are
nevertheless significant in nature. The incremental improvements in
health outcomes achieved by given reductions in exposure cannot be
quantified for non-cancer health effects associated with TCE exposure,
and therefore cannot be converted into monetized benefits. The
qualitative discussion throughout this rulemaking and in the Economic
Analysis highlights the importance of these non-cancer effects. These
effects include willingness-to-pay to avoid illness, which includes
cost of illness and other personal costs such as pain and suffering.
Considering only monetized benefits underestimates the impacts of TCE
adverse outcomes and therefore underestimates the benefits of this
proposed rule.
3. Cost Effectiveness of the Proposed Regulatory Action and of the 1 or
More Primary Alternative Regulatory Actions Considered by the
Administrator
Cost effectiveness is a method of comparing certain actions in
terms of the expense per item of interest or goal. A goal of this
proposed regulatory action is to achieve the risk reduction standard in
a [more] cost-effective manner, with estimated [lower] costs and
[higher] net benefits, than other considered alternative regulatory
actions (Ref. 3). The proposed regulatory action would cost $6.8-7.7
million per potential prevented cancer case while the primary
alternative regulatory action would cost $7.1-8.0 million (using the 3%
discount rate) to achieve the same goals. While the primary alternative
regulatory action is lower in cost compared to the proposed regulatory
action, the difference is small (Ref. 3).
VIII. TSCA Section 9 Analysis, Section 14, and Section 26
Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency following submission of any such report.
As discussed in this unit, for this proposed rule, the Administrator
proposes to exercise his discretion not to determine that the
unreasonable risk from TCE under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA.
In addition, TSCA section 9(d) instructs the Administrator to
consult and coordinate TSCA activities with other Federal agencies for
the purpose of achieving the maximum enforcement of TSCA while imposing
the least burdens of duplicative requirements. For this proposed rule,
EPA has and continues to coordinate with appropriate Federal executive
departments and agencies including OSHA and the Consumer Product Safety
Commission (CPSC), to, among other things, identify their respective
[[Page 74774]]
authorities, jurisdictions, and existing laws with regard to TCE, which
are summarized in this unit.
OSHA requires that employers provide safe and healthful working
conditions by setting and enforcing standards and by providing
training, outreach, education and assistance. As described in Unit
II.C., OSHA, in 1971, established a PEL for TCE of 100 ppm of air as an
8-hour TWA with an acceptable ceiling concentration of 200 ppm and an
acceptable maximum peak above the acceptable ceiling concentration for
an eight-hour shift of 300 ppm, maximum duration of 5 minutes in any 2
hours. However, the exposure limits established by OSHA are higher than
the exposure limit that EPA determined would be sufficient to address
the unreasonable risk identified under TSCA from occupational
inhalation exposures associated with certain conditions of use. Gaps
exist between OSHA's authority to set workplace standards under the OSH
Act and EPA's obligations under TSCA section 6 to eliminate
unreasonable risk presented by chemical substances under the conditions
of use. Health standards issued under section 6(b)(5) of the OSH Act
must reduce significant risk only ``to the extent feasible.'' 29 U.S.C.
655(b)(5). To set PELs for chemical exposure, OSHA must first establish
that the new standards are economically and technologically feasible
(79 FR 61384 and 61387, Oct. 10, 2014). But under TSCA section 6(a),
EPA's substantive burden is to demonstrate that, as regulated, the
chemical substance no longer presents an unreasonable risk, with
unreasonable risk being determined without consideration of costs or
other nonrisk factors. Thus, if OSHA were to initiate a new action to
lower its PEL, the difference in standards between the OSH Act and TSCA
may well result in the OSHA PEL being set at a higher level than the
exposure limit that EPA determined would be sufficient to address the
unreasonable risk under TSCA.
In addition, OSHA may set exposure limits for workers, but its
authority is limited to the workplace and does not extend to consumer
uses of hazardous chemicals, and thus OSHA cannot address the
unreasonable risk from TCE under all of its conditions of use, which
include consumer uses. OSHA also does not have direct authority over
State and local employees, and it has no authority over the working
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
CPSC, under authority provided to it by Congress in the CPSA,
protects the public from unreasonable risk of injury or death
associated with the use of consumer products. Under the CSPA, CPSC has
the authority to regulate TCE in consumer products, but not in other
sectors such as automobiles, industrial and commercial products, or
aircraft for example (Ref. 81). Further, a consumer product safety rule
under the CPSA must include a finding that ``the benefits expected from
the rule bear a reasonable relationship to its costs,'' 15 U.S.C.
2058(f)(3)(E), whereas EPA must apply TSCA risk management requirements
to the extent necessary so that the chemical no longer presents
unreasonable risk and only consider costs and benefits of the
regulatory action to the extent practicable, 15 U.S.C. 2605(a), (c)(2).
Additionally, the 2016 amendments to TSCA reflect Congressional intent
to ``delete the paralyzing `least burdensome' requirement,'' 162 Cong.
Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as
originally enacted, which required EPA to use ``the least burdensome
requirements'' that protect ``adequately'' against unreasonable risk,
15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under
the CPSA must impose ``the least burdensome requirement which prevents
or adequately reduces the risk of injury for which the rule is being
promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at
variance with recent revisions to TSCA, affect the availability of
action CPSC may take under the Federal Hazardous Substances Act (FHSA)
relative to action EPA may take under TSCA. 15 U.S.C. 1262.
EPA therefore concludes that TSCA is the only regulatory authority
able to prevent or reduce unreasonable risk of TCE to a sufficient
extent across the range of conditions of use, exposures, and
populations of concern. This unreasonable risk can be addressed in a
more coordinated, efficient, and effective manner under TSCA than under
different laws implemented by different agencies. Moreover, the
timeframe and any exposure reduction as a result of updating OSHA or
CPSC regulations cannot be estimated, while TSCA requires a much more
accelerated 2-year statutory timeframe for proposing and finalizing
regulatory requirements to address unreasonable risk. Further, there
are key differences between the finding requirements of TSCA and those
of the OSH Act, CPSA, and FHSA. For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk from TCE may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. However, EPA is requesting public comment
on this issue (i.e., the sufficiency of an action taken under a Federal
law not administered by EPA).
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk unless
the Administrator determines in the Administrator's discretion that it
is in the public interest to protect against such risk under TSCA. In
making such a public interest finding, TSCA section 9(b)(2) states:
``the Administrator shall consider, based on information reasonably
available to the Administrator, all relevant aspects of the risk . . .
and a comparison of the estimated costs and efficiencies of the action
to be taken under this title and an action to be taken under such other
law to protect against such risk.''
Although several EPA statutes have been used to limit TCE exposure
(Ref. 9), regulations under those EPA statutes have limitations because
they largely regulate releases to the environment, rather than
occupational or consumer exposures. While these limits on releases to
the environment are protective in the context of their respective
statutory authorities, regulation under TSCA is also appropriate for
occupational and consumer exposures and in some cases can provide
upstream protections that would prevent the need for release
restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)).
The primary exposures and unreasonable risk to consumers,
bystanders, workers, and ONUs would be addressed by EPA's proposed
prohibitions and restrictions under TSCA section 6(a). In contrast, the
timeframe and any exposure reduction as a result of updating
regulations for TCE under the CAA, CWA, or RCRA cannot be estimated,
nor would they address the direct human exposure to consumers,
bystanders, workers, and ONUs from the conditions of use evaluated in
the 2020 Risk Evaluation for TCE. More specifically, none of EPA's
other statutes (e.g., RCRA, CAA, CWA) can address exposures to workers
and ONUs related to the specific
[[Page 74775]]
activities that result in occupational exposures, for example those
associated with RCRA covered disposal requirements, such as in 40 CFR
261.24 and 40 CFR 268.3. EPA therefore concludes that TSCA is the most
appropriate regulatory authority able to prevent or reduce risks of TCE
to a sufficient extent across the range of conditions of use,
exposures, and populations of concern.
For these reasons, the Administrator does not determine that
unreasonable risk from TCE under the conditions of use evaluated in the
2020 TSCA Risk Evaluation for TCE, could be eliminated or reduced to a
sufficient extent by actions taken under other Federal laws
administered in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI that may occur
if this rulemaking is finalized as proposed. Under TSCA section
14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that
establishes a ban or phase-out of a chemical substance, the protection
from disclosure of any CBI regarding that chemical substance and
submitted pursuant to TSCA will be ``presumed to no longer apply,''
subject to the limitations identified in TSCA section 14(b)(4)(B)(i)
through (iii). If this rulemaking is finalized as proposed, then
pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against
protection from disclosure would apply only to information about the
specific conditions of use that this rulemaking would prohibit or phase
out. Manufacturers or processors seeking to protect such information
would be able to submit a request for nondisclosure as provided by TSCA
sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure
would need to be submitted within 30 days after receipt of notice from
EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such
notice via the Central Data Exchange or CDX.
D. TSCA Section 26 Considerations
In accordance with TSCA section 26(h), EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science.
As in the case of the unreasonable risk determination, risk management
decisions for this proposed rule, as discussed in Unit III.B.3. and
Unit V., were based on a risk evaluation, that was subject to public
comment and independent, expert peer review, and was developed in a
manner consistent with the best available science and based on the
weight of the scientific evidence as required by TSCA sections 26(h)
and (i) and 40 CFR 702.43 and 702.45.
In particular, the ECEL values considered for the WCPP are derived
from the analysis in the 2020 Risk Evaluation for TCE. The proposed
ECEL value of 0.0011 ppm as an 8-hour TWA is based on developmental
toxicity, the most sensitive acute and chronic non-cancer health
endpoint, specifically calculated based on the occupational acute, non-
cancer human equivalent concentration (HEC) for fetal cardiac defects
(Ref. 13). This is the concentration at which an adult human would be
unlikely to experience the specified adverse effects if exposed for a
working lifetime, including susceptible subpopulations. Similarly, the
ECEL identified under the primary alternative regulatory option, based
on a different health endpoint, immunotoxicity, is derived from the
analysis in the 2020 Risk Evaluation for TCE. This ECEL is 0.0040 ppm
as an 8-hour TWA which is based on the chronic non-cancer occupational
HEC for autoimmunity (Ref. 14). As discussed in Unit VI.A., among the
non-cancer adverse health effects, the drivers for EPA's whole chemical
unreasonable risk determination for TCE under TSCA were identified as
immunotoxicity, acute immunosuppression, and chronic autoimmunity, from
inhalation and dermal exposures (Ref. 2). Therefore, reducing exposures
remaining above the ECEL of 0.0040 ppm would reduce the contribution to
the unreasonable risk of injury to health driven by inhalation
exposures in an occupational setting for those conditions of use
identified as presenting unreasonable risk in the 2020 Risk Evaluation
for TCE under TSCA (Ref. 1, 14).
The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decisions have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rulemaking. Additional information on the peer review and
public comment process, such as the peer review plan, the peer review
report, and the Agency's response to comments, can be found in EPA's
risk evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0737).
IX. Requests for Comment
EPA is requesting public comment on all aspects of this proposal,
including the proposed and primary alternative regulatory actions and
all individual elements of these, and all supporting analysis.
Additionally, within this proposal, the Agency is soliciting feedback
from the public on specific issues throughout this proposed rule. For
ease of review, this unit summarizes those specific requests for
comment.
1. EPA is requesting public comment on all elements of the proposed
regulatory action and the primary alternative regulatory action.
2. EPA is requesting public comment regarding the need for
exemptions from the rule (and under what specific circumstances),
including exemptions from the proposed regulatory action and the
primary alternative regulatory action, pursuant to the provisions of
TSCA section 6(g).
3. EPA requests comment on information that would allow EPA to
quantify the magnitude of avoided risk of fetal cardiac defects due to
reductions in TCE exposure under the proposed rulemaking.
4. EPA requests comment on whether EPA should promulgate
definitions for each condition of use evaluated in the 2020 Risk
Evaluation for TCE, and, if so, whether the descriptions in Unit
III.B.1. are consistent with the conditions of use evaluated in the
2020 Risk Evaluation for TCE and whether they provide a sufficient
level of detail to improve the clarity and readability of the
regulation.
5. EPA requests comment on the proposed compliance dates for
prohibitions of TCE manufacturing, processing, distribution in
commerce, and use and whether additional time is needed, for example,
for products to clear the channels of trade, or for implementing the
use of substitutes; comments should include documentation such as the
specific use of the chemical throughout the supply chain; concrete
steps taken to identify, test, and qualify substitutes for those uses
(including details on the substitutes tested and the specific
certifications that would require updating); and estimates of the time
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply.
6. As noted in Unit III.B.1.f., this proposal does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the
impacts, if any, that a prohibition on the processing
[[Page 74776]]
of TCE into a formulation, mixture or reaction product in other
chemical products and preparations, or other aspects of this proposal,
may have on the production and availability of any pesticide or other
substance excluded from the TSCA definition of ``chemical substance.''
7. EPA requests comment on whether it should consider a de minimis
level of TCE in formulations to account for impurities (e.g., 0.1% or
0.5%) when finalizing the prohibitions described in Units V.A.1.b. and
c., and, if so, information on and rationale for any level that should
be considered de minimis.
8. EPA requests comment on whether additional recordkeeping
requirements are warranted or additional time would be needed, for
example, to begin the phaseout of processing TCE as an intermediate for
the manufacture of HFC-134a.
9. EPA is seeking comment on the actions that manufacturers who
process TCE for the production of HFC-134a would take as a result of
the proposed phaseout in Unit V.A.1.d, and whether this would motivate
a decision to cease manufacture earlier than they would otherwise under
the AIM Act phase-down.
10. EPA requests comment on whether the 270-day proposed compliance
date is practicable, whether additional time is needed, for example,
for a regulated entity to implement a change to their disposal
processes or to transition to alternative disposal methods and what
those alternative disposal methods would be, and their cost and
feasibility.
11. EPA is requesting comment on how entities could demonstrate
that they are reducing exposures to the extent possible (including
considerations for technological feasibility) and is also requesting
comment on whether EPA's requirement should be that entities ensure
that exposures are reduced below the ECEL, rather than to the extent
possible or lowest achievable level.
12. For the ECEL value of 0.0011 ppm, proposed as part of the WCPP,
EPA requests comment on the use of TSCA section 6(c)(2) to tailor the
risk management actions where necessary to protect PESS.
13. EPA is requesting comment on the use of the ECEL value of
0.0040 ppm in the WCPP in the alternative regulatory action.
14. EPA is requesting comment on the selection of the fetal cardiac
defects endpoint for the ECEL of 0.0011 ppm in the proposed regulatory
action, rather than the immunotoxicity endpoint on which the
unreasonable risk determination is based, which would result in an ECEL
of 0.0040 ppm, as further detailed in Unit IV.A.
15. EPA is requesting comment on personal air sampling devices that
are capable of detecting indoor air TCE concentrations at or below the
proposed ECEL action level of 0.00055 ppm (0.0029 mg/m\3\) with the
requisite precision and accuracy.
16. EPA is requesting comment on using OSHA Method 1001, which has
a personal breathing zone limit of detection for TCE of 18 ppb, or
0.018 ppm, to set an interim exposure limit of 0.036 ppm, with an
action level of 0.018 ppm, as described further in Unit V.A.2.b.i.
17. EPA requests comments regarding replacing the proposed
prohibitions with compliance with the WCPP, in the instance that
regulated entities are able to consistently demonstrate compliance with
an ECEL through effective controls.
18. EPA requests comment on the potential to develop future
technologies (e.g., engineering controls, administrative controls, PPE)
involving TCE for the conditions of use listed in Unit V.A.1.a., Unit
V.A.1.d., and Unit V.A.3 that would facilitate successful
implementation of the WCPP, including an ECEL of 0.0011 ppm for TCE,
dermal protection, and ancillary requirements described in Unit IV.A.
19. EPA requests comment on the feasibility of controlling worker
exposures to TCE at or below the proposed ECEL, and the accuracy of
detections measurements at this level.
20. EPA requests comment on whether a phased approach to an ECEL is
desirable; that is, an approach that would establish a timeframe for
meeting the ECEL as well as a shorter timeframe for meeting a
concentration level higher than the ECEL (but lower than the PEL) that
is currently considered achievable. EPA welcomes data or information to
demonstrate that meeting the proposed ECEL over a sustained period of
time would be feasible and measurable.
21. EPA requests comments that provide supported recommendations
for one or more incremental exposure values and associated timelines
for achieving the incremental exposure levels and the currently
proposed ECEL of 0.0011 ppm, and comments that consider and provide
information on the needed advancements in exposure monitoring methods,
analytical methods, and exposure controls, including expected timelines
for developing these capabilities.
22. EPA requests comment on how owners and operators should
identify the lowest achievable exposure level, what documentation would
be needed to support that further reductions are not possible, and
whether EPA should provide a definition of meeting the ECEL to the
extent possible. Additionally, EPA requests comment on whether current
monitoring methods are able to detect airborne concentrations at the
ECEL and action level values. EPA expects that detection and adherence
to extremely low-ppm levels of TCE may present challenges to some in
the regulated community; therefore, EPA is also requesting comment on
whether EPA should propose specific requirements following results
indicating non-detectable concentrations of TCE (non-detects), or a
requirement that a specific monitoring method be used.
23. EPA is soliciting comment regarding an ECEL action level that
is half the ECEL and any associated provisions related to the ECEL
action level when the ECEL is significantly lower than the OSHA PEL.
EPA is also soliciting comment on whether the ECEL action level should
be aligned with the OSHA PEL action level (typically set at half the
limit), due to the fact that PEL accounts for technological feasibility
and the action level is not necessarily designed to be health
protective. Since exposure below the ECEL would be health protective,
EPA seeks comment on whether the action level should be set at a
different value closer to the ECEL that would trigger increased
monitoring to ensure that the ECEL is not exceeded, and whether
technological feasibility should be considered in setting the action
level..
24. EPA requests comment on whether the action level should be set
at a different value closer to the ECEL that would trigger increased
monitoring to ensure that the ECEL is not exceeded, and whether
technological feasibility should be considered in setting the action
level.
25. EPA is soliciting comments regarding the timing of the initial
exposure monitoring so that it would be representative of all tasks
involving TCE where exposures may approach the ECEL. EPA is also
soliciting comments regarding use of area source monitoring instead of
personal breathing zone as a representative sample of exposures.
26. EPA requests comment on the timeframes for periodic monitoring
outlined in Table 1 of Unit V.A.2.
27. EPA is soliciting comment on requiring warning signs to
demarcate regulated areas, such as the requirements found in OSHA's
General Industry Standard for Beryllium.
[[Page 74777]]
28. EPA is requesting comment on whether the owner or operator
should be required to permit designated representatives of employees
and other workers to enter regulated areas to observe exposure
monitoring similar to typical OSHA Standard requirements, e.g., 29 CFR
1910.1024(d)(7).
29. EPA is requesting comment on whether there should be a
requirement to replace cartridges or canisters after a certain number
of hours, such as the requirements found in OSHA's General Industry
Standard for 1,3-Butadiene, or a requirement for a minimum service life
of non-powered air-purifying respirators such as the requirements found
in OSHA's General Industry Standard for Benzene.
30. EPA is requesting comment on whether the timeframe to provide
PPE to exposed workers should be shorter (e.g., within two weeks after
the receipt of any exposure monitoring that indicates exposure
exceeding the ECEL), given the severity of the effect, as discussed in
Unit V.A.2.
31. EPA requests comment on the degree to which additional guidance
related to use of gloves might be necessary. Additionally, EPA requests
comment on whether EPA should incorporate additional dermal protection
requirements into the exposure control plan or require consideration of
the hierarchy of controls for dermal exposures.
32. EPA is requesting comment on how owners and operators can
engage with potentially exposed persons on the development and
implementation of an exposure control plan and PPE program.
33. EPA requests comment relative to the ability of owners or
operators to conduct initial monitoring within 6 months after date of
publication of the final rule in the Federal Register, and anticipated
timeframes for any procedural adjustments (i.e., use of new
technologies for personal breathing zone monitoring at extremely low-
ppm levels of TCE) needed to comply with the requirements outlined in
Unit V.A.2., including establishment of a respiratory protection
program and development of an exposure plan.
34. EPA is requesting comment regarding the amount of time, if any,
it would take the regulated community to develop a method to measure at
or below the ECEL over an entire work shift. EPA is interested in what
levels of detection are possible based on existing monitoring methods,
justification for the timeframe of the specific steps needed to develop
a more sensitive monitoring method, and any additional detailed
information related to establishing a monitoring program to reliably
measure TCE at or below the ECEL.
35. EPA also requests comment relative to the ability of owners or
operators to implement dermal protection within 6 months of publication
of the final rule in the Federal Register, and anticipated timeframes
for any procedural adjustments needed to comply with the requirements
outlined in Unit V.A.2.
36. EPA requests comment on whether 10 years is an appropriate
timeframe for the TSCA section 6(g) exemption for industrial and
commercial use of TCE as a processing aid for battery separator
manufacturing (lead-acid and lithium battery separators).
37. EPA requests comment on whether 50 years is an appropriate
timeframe for the TSCA section 6(g) exemption for the industrial and
commercial use of TCE as a laboratory chemical (specifically in lab use
essential for essential laboratory activities), Specifically, EPA
requests comment on the anticipated duration of TCE cleanup projects,
and whether there will be projects that continue and require the use of
TCE as a laboratory chemical for the analysis of contaminated soil,
air, and water samples past 50 years.
38. EPA requests comment on the TSCA section 6(g) exemption for
continued emergency use of TCE in the furtherance of NASA's mission as
described in Unit V.A.3.iii.a.vi, and whether any additional conditions
of use should be included, in particular for any uses qualified for
space flight for which no technically or economically feasible safer
alternative is available. Additionally, EPA requests comment on what
would constitute sufficient justification of an emergency.
39. EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in Unit V.A.2.
40. EPA requests comment on the primary alternative regulatory
action and whether any elements of this primary alternative regulatory
action described in Unit IV.B. should be considered as EPA develops the
final regulatory action. EPA also requests comment on the
practicability of the timeframes under the primary alternative
regulatory action outlined in Unit V.B. compared to the timeframes
identified for the proposed regulatory action in Unit V.A.
41. EPA requests comment on the practicability of the timeframes
outlined for the phaseout of processing TCE as an intermediate for HFC-
134a manufacture in Unit V.B. compared to the timeframes identified for
the proposed regulatory action in Unit V.A., including consideration of
the need for manufacturing (including import), and distribution in
commerce to continue during the period of the phaseout.
42. EPA requests comment on the applicability to the private sector
of proposed regulatory actions pertaining specifically to Federal
agencies, namely industrial uses for DoD vessel requirements and for
closed-loop batch vapor degreasing for rayon fabric scouring for rocket
booster nozzle production. EPA requests comment on the extent to which
the private sector would be affected by a prohibition on these uses.
43. EPA requests comment on whether the three-year alternative
timeline would be practicable or whether additional time is needed, for
example, for a regulated entity to implement a change to their
wastewater collection, treatment, or disposal processes or
infrastructure, and what those alternative disposal methods may be.
44. EPA requests comment on the ability of regulated entities to
conduct initial monitoring within 12 months, anticipated timeframes for
any procedural adjustments needed to comply with the requirements, and
the extent to which this option could result in additional exposure,
compared to the proposed regulatory option as described in Unit V.A.
45. EPA requests comment on the practicability of the timeframes
outlined in this unit, when compared to the timeframes identified for
the proposed regulatory action in Unit V.A. EPA requests comment on
whether any elements of the primary alternative regulatory action
described in this unit should be considered as EPA develops the final
regulatory action, e.g., whether EPA should consider the timeframes for
implementation of a WCPP presented in this primary alternative
regulatory action and the ECEL value presented in the proposed
regulatory action.
46. EPA requests comment on the existing practices (e.g.,
engineering controls, administrative controls, PPE) involving TCE use
in these conditions of use, as to whether activities may take place in
closed systems and the degree to which users of TCE in these sectors
could successfully implement an ECEL of 0.0011 ppm or an ECEL of 0.0040
ppm as an 8-hour TWA, dermal protection, and ancillary requirements
described in Units V.A.2. and V.B.2.
47. EPA requests comment on the extent to which the use of TCE for
vapor
[[Page 74778]]
degreasing of narrow tubing is a critical use for which no technically
and economically feasible safer alternative is available.
48. EPA therefore requests comment on the Agency's consideration of
an exemption from the prohibition on disposal of TCE by industrial pre-
treatment, industrial treatment, or publicly owned treatment works for
cleanup projects undertaken under the authority of CERCLA, RCRA, or
other federal, state, or local government environmental laws,
regulations, or requirements.
49. EPA requests comment on whether 50 years is a reasonable
timeframe for a TSCA section 6(g)(1)(A) exemption for the cleanup of
TCE-contaminated water and groundwater sites. Specifically, EPA
requests comment on the anticipated duration of TCE cleanup projects,
and whether there will be projects that may continue and require the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works beyond 25 years.
50. EPA requests comment on whether industry anticipates increased
releases of TCE to outdoor air associated with the implementation of
the WCPP. EPA requests comment on whether owners and operators should
be required to attest in their exposure control plan that engineering
controls selected do not increase emissions of TCE to ambient air
outside of the workplace and document in their exposure control plan
whether additional equipment was installed to capture emissions of TCE
to ambient air. EPA requests comment on how such a requirement could
impact the availability, feasibility, or cost of engineering controls
as a means to reduce workplace exposures to or below the proposed ECEL.
EPA is also soliciting comment on the frequency and nature of air
monitoring EPA should consider including as requirements in the final
rule.
51. EPA requests comments on all aspects of the TSCA section 6(g)
exemptions described in Units V.A.3. and V.B.3., including whether
compliance with the WCPP should also be required during the period of
the exemption.
52. EPA is soliciting comment on if the exemption for laboratory
use of TCE as described in Unit V.A.3.a.iii should include lab use of
TCE for research and development purposes for objectives broader than
cleanup activities or exposure monitoring, such as research into TCE
alternatives, whether these broader objectives should be limited to
federal agencies and their contractors or expanded to include others,
and whether a shorter time period, such as 10 years, should be imposed
on these broader research and development activities.
53. EPA is soliciting comment on whether it should specify the type
of batch vapor degreasing operation, such as open-top or closed loop
batch vapor degreasing, that would be exempt from prohibition as part
of the primary alternative regulatory action for the industrial and
commercial use of TCE in batch vapor degreasing for essential aerospace
parts and narrow tubing used in medical devices and whether EPA should
consider different exemption timeframes for different types of vapor
degreasing operations.
54. EPA requests comments on subsections of conditions of use,
which by nature of their infrequent occurrence, could meet the ECEL
without having their employees wear high APF levels of PPE on a daily
basis.
55. EPA requests public comment on the rationale for proposing
prohibitions as the preferred risk management approach. In addition,
EPA requests comment regarding the number of businesses and other
entities that could potentially close as well as associated costs with
a prohibition of TCE for the industrial and commercial conditions of
use identified in Unit V.A.1.
56. EPA requests comment on the effectiveness of a limited access
program, such as a point-of-sale self-certification or other
administrative controls, to address the unreasonable risk of TCE, in
particular for facilities with occupational exposures to TCE that may
not be able to meet the WCPP requirements of this proposed rulemaking.
57. EPA is soliciting comments on whether there are products in use
or available for sale relevant to these conditions of use that contain
TCE at this time, so that EPA can ascertain whether there are
alternatives that benefit human health or the environment as compared
to such use of TCE.
58. EPA is requesting comment on the Alternatives Assessment as a
whole.
59. EPA is requesting public comment on an issue raised in its TSCA
section 9(a) Analysis described in Unit VIII.A., (i.e., the sufficiency
of an action taken under a Federal law not administered by EPA).
60. Following Panel report recommendations (Ref. 32) and in
response to input provided by SERs, EPA is requesting comment on the
following topics as outlined in the SBAR Panel Report:
EPA requests public comment on the extent to which a
regulation under TSCA section 6(a) could minimize requirements, such as
testing and monitoring protocols, recordkeeping, and reporting
requirements, which may exceed those already required under OSHA's
regulations for TCE.
EPA requests public comment on reasonable compliance
timeframes for small businesses, specifically on whether and how to
provide longer compliance timeframes for transitioning to alternatives
for uses requiring reformulation and cleaning processes for cleaning
parts for national defense or cleaning medical devices.
EPA requests public comment on differing compliance or
reporting requirements or timetables that account for the resources
available to small entities.
EPA requests public comment on any additional appropriate
factors for identifying reasonable compliance timeframes and how to
weigh the factors for vapor degreasing and other industries.
EPA requests public comment the feasibility of entities
complying with and monitoring for a potential ECEL of either 0.0011 ppm
or 0.0040 ppm, specifically regarding potential costs that could be
incurred using strategies to meet the requirements of such a standard,
such as engineering, administrative, or prescriptive controls and how
feasible it would be for entities to implement these strategies in
their operations.
EPA requests public comment on the feasibility of use of
alternatives to TCE and their availability for conditions of use that
drive the unreasonable risk.
EPA requests public comment on a training and
certification program for a commercial user to obtain a TCE-containing
product from a retailer, such as industrial supply stores or online
retailers.
EPA requests public comment on a de minimis level in the
case of an impurity or trace amounts of TCE in products.
EPA requests public comment on whether to allow the use of
TCE by entities that could, based on demonstrated ability through
monitoring data, meet the ECEL under a workplace chemical protection
program.
EPA requests public comment on how the rulemaking should
consider TCE alternatives in light of ongoing regulatory scrutiny.
EPA requests public comment on whether chemicals
undergoing risk evaluation would be likely to be
[[Page 74779]]
considered as viable alternatives and, if so, in which circumstances.
EPA requests public comment on potential challenges
associated with monitoring TCE below 0.0011 ppm and 0.0040 ppm.
EPA requests public comment on whether the use of TCE in a
closed-loop vapor degreasing system, when combined with requirements of
a potential workplace chemical protection program, could meet the ECELs
for TCE.
X. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation for Trichloroethylene. EPA Document
#740R18008. November 2020.
2. EPA. Final Revised Unreasonable Risk Determination for
Trichloroethylene, Section 5. December 2022.
3. EPA. Economic Analysis of the Proposed Regulation of
Trichloroethylene. 2023.
4. EPA. Phasedown of Hydrofluorocarbons: Establishing the Allowance
Allocation and Trading Program Under the American Innovation and
Manufacturing Act; Final Rule. October 5, 2021.
5. A. Tinker et al. Inpatient Hospitalization Costs Associated with
Birth Defects Among Persons of All Ages--United States, 2013. MMWR.
Morbidity and mortality weekly report vol. 66,2 41-46. January 20,
2017.
6. M. Chen et al. Children with Heart Conditions and Their Special
Health Care Needs--United States, 2016. MMWR. Morbidity and
mortality weekly report vol. 67,38 1045-1049. 28. Sept. 28, 2018.
7. N. McClung et al. Financial burdens and mental health needs in
families of children with congenital heart disease. Congenital heart
disease 13.4 (2018): 554-562. April 6, 2018.
8. EPA. ChemView: Trichloroethylene (TCE), 79-01-6. Last updated on
June 2, 2023. https://chemview.epa.gov/chemview/?tf=0&ch=79-01-6&su=256737574985&as=31098&ac=115166378999&ma=4-11-1981377-4_16848473-4_16848474-4_49007566&gs=&tds=0&tdl=10&tas1=1&tas2=asc&tas3=undefined&tss=&modal=detail&modalId=100616&modalSrc=2-5-10-1-6378999-4-11-1981377.
9. EPA. Summary of EPA Regulations Pertaining to Trichloroethylene
(TCE); and Other Federal, State, and International Regulations.
September 2023.
10. OSHA. Standard Interpretations: 8-hr total weight average (TWA)
permissible exposure limit (PEL). December 18, 2003. https://www.osha.gov/laws-regs/standardinterpretations/2003-12-18-1.
11. EPA. Trichloroethylene (TCE); Revision to the Toxic Substances
Control Act (TSCA) Risk Determination; Notice of Availability.
Federal Register (88 FR 1222, January 9, 2023) (FRL-9945-02-OCSPP).
12. NIOSH. Hierarchy of Controls. Last Reviewed January 17, 2023.
https://www.cdc.gov/niosh/topics/hierarchy/.
13. EPA. Second Existing Chemical Exposure Limit (ECEL)
(Developmental Toxicity) for Occupational Use of Trichloroethylene.
March 31, 2022.
14. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Trichloroethylene. February 22, 2021.
15. AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992).
16. ACGIH. ACGIH TLVs. n.d. https://www.acgih.org/trichloroethylene/.
17. NIOSH. NIOSH Pocket Guide to Chemical Hazards--
Trichloroethylene. Last Reviewed October 30, 2019. https://www.cdc.gov/niosh/npg/npgd0629.html.
18. NIOSH. Appendix A--NIOSH Potential Occupational Carcinogens.
Last Reviewed October 17, 2018. https://www.cdc.gov/niosh/npg/nengapdxa.html.
19. State of California Department of Industrial Relations. Table
AC-1 Permissible Exposure Limits For Chemical Contaminants. n.d.
https://www.dir.ca.gov/title8/5155table_ac1.html.
20. NIOSH. Recommendations for Occupational Safety and Health.
January 1992.
21. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 20, 2021).
22. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
23. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
24. EPA. EPA Announces Path Forward for TSCA Chemical Risk
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
25. EPA. TSCA Science Advisory Committee on Chemicals Meeting
Minutes and Final Report. March 24-27, 2020.
26. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
27. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE).
June 15 and July 8, 2021.
28. W. Heiger-Bernays and G. Nielsen. Environmental Justice
Consultation Comment 1 for TCE and PCE. July 5, 2021.
29. S. Rayasam. Environmental Justice Consultation Comment 2 for TCE
and PCE. June 16, 2021.
30. S. Liu. Environmental Justice Consultation Comment 3 for TCE and
PCE. August 20, 2021.
31. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and
Perchloroethylene (PCE). July 2021.
32. Small Business Advocacy Review Panel. Final Report of the Small
Business Advocacy Review Panel on EPA's Planned Proposed Rule for
Trichloroethylene (TCE). April 4, 2023.
33. EPA. Initial Regulatory Flexibility Analysis (IRFA) for Proposed
Regulation of Trichloroethylene.
34. EPA. Public Webinar on Trichloroethylene (TCE): Risk Evaluation
and Risk Management under TSCA Section 6. December 15, 2020.
35. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Trichloroethylene under TSCA Section 6(a). May 19, 2023.
36. EPA. 2021 Policy on Children's Health. October 5, 2021.
37. EPA. Problem Formulation of the Risk Evaluation for
Trichloroethylene. May 2018.
38. EPA. Scope of the Risk Evaluation for Trichloroethylene. June
2017.
39. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane.
August 2020.
40. EPA. Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain
Conditions of Use Under Section 6(a) of the Toxic Substances Control
Act (TSCA). April 12, 2022.
41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
42. EPA. Trichloroethylene (TCE); Revision to Toxic Substances
Control Act (TSCA) Risk Determination; Respone to Public Comments.
December 2022.
43. NASA. Solid Rocket Motor Nozzles Mission Critical Requirement
for Trichloroethylene. February 1, 2023.
44. OSHA. Occupational Exposure to Methylene Chloride. January 10,
1997.
45. EPA. Passive Samplers for Investigations of Air Quality: Method
Description, Implementation, and Comparison to Alternative Sampling
Methods. December 2014.
46. EPA. Second Existing Chemical Exposure Limit (ECEL)
(Developmental Toxicity) for Occupational Use of Trichloroethylene;
Appendix B. March 31, 2022.
47. OSHA. Personal Protective Equipment. 2023.
48. ENTEK. ENTEK International LLC, Request for Section 6(g)
Exemption. July 14, 2021.
49. Microporous. Microporous LLC (``Microporous''), Request for
Section 6(g) Exemption. August 10, 2022.
50. Battery Council International. Letter in Support of ENTEK
Request for Section 6(g) Exemption for Battery Separator
Manufacturing. September 3, 2021.
[[Page 74780]]
51. The Federal Consortium for Advanced Batteries. Executive Summary
National Blueprint For Lithium Batteries 2021-2030. June 2021.
52. ENTEK. Analysis of Alternatives for the use of trichloroethylene
as an extraction solvent for removal of process oil and formation of
the porous structure in polyethylene based separators used in lead-
acid batteries. August 2021.
53. EPA. Assistant Administrator Meeting with ENTEK on a TSCA
Section 6(g) Exemption Request in Risk Management for
Trichloroethylene (TCE). February 15, 2022.
54. ENTEK. Attachment B to July 14, 2021 Letter From ENTEK EPA.
55. European Chemical Agency. Adopted opinions and previous
consultations on applications for authorisation. n.d. https://echa.europa.eu/applications-for-authorisation-previous-consultations/-/substance-rev/6385/term; https://echa.europa.eu/applications-for-authorisation-previous-consultations/-/substance-rev/6384/term.
56. NASA. Known Uses of Trichloroethylene. December 14, 2022.
57. K. Black. The Nuclear Asphalt Content Gauge. 1995. https://highways.dot.gov/public-roads/winter-1995/nuclear-asphalt-content-gauge.
58. U.S. Department of State. A Strategic Framework for Space
Diplomacy. May 25, 2023.
59. M. Finckenor. Materials for Spacecraft. NASA. 2016.
60. The Boeing Company. Comments Supporting Request for Additional
Information on Trichloroethylene (TCE); Rulemaking Under TSCA
Section 6(a). May 6, 2022.
61. The Boeing Company. Comments Concerning Trichloroethylene (TCE);
Regulation of Use in Vapor Degreasing Under TSCA Section 6(a). May
19, 2017.
62. The Boeing Company. Information on FAA Certification. December
9, 2022.
63. 3M. 3M to Exit PFAS Manufacturing by the End of 2025. December
20, 2022. https://news.3m.com/2022-12-20-3M-to-Exit-PFAS-Manufacturing-by-the-End-of-2025.
64. Viant. Viant Comments on the November 2020 TCE Risk Evaluation.
November 17, 2021.
65. EPA. Meeting Summary--EPA Visit at the Integer facility in
Minneapolis, MN. October 19, 2017.
66. EPA. National Air Emission Standards for Hazardous Air
Pollutants: Halogenated Solvent Cleaning. May 3, 2007.
67. PPG. PPG TSCA Section 6(g) Exemption Request. June 29, 2023.
68. EPA. Trichloroethylene (TCE); Regulation of Use in Vapor
Degreasing Under TSCA Section 6(a). Federal Register. (82 FR 7432,
January 19, 2017)(FRL-9950-08).
69. NIOSH. NIOSH Guide to the Selection and Use of Particulate
Respirators. January 1996. https://www.cdc.gov/niosh/docs/96-101/default.html.
70. Arkema. Arkema Inc. Comments on Draft Toxic Substances Control
Act (TSCA) Risk Evaluation and TSCA Science Advisory Committee on
Chemicals (SACC) Meetings. April 27, 2020.
71. EPA. Alternatives Assessment for Proposed Regulation of
Trichloroethylene.
72. EPA. Meeting with Safechem on Risk Management under TSCA Section
6(a) for Trichloroethylene. March 23, 2023.
73. Koura. Production of R-134a. 2017.
74. National Cleaners Association. National Cleaners Association
Comments on the Phaseout of Trichloroethylene (TCE). February 13,
2023.
75. Axiall. Safety Data Sheet for Trichlorethylene. October 26,
2013.
76. EPA. EPA Response to Letter of Concern from Louisiana Department
of Environmental Quality's (LDEQ) and the Louisiana Department of
Health (LDH). October 12, 2022.
77. EPA. Memorandum Trichloroethylene (TCE): Fenceline Technical
Support--Ambient Air Pathway. March 3, 2022.
78. EPA. Draft TSCA Screening Level Approach for Assessing Ambient
Air and Water Exposures to Fenceline Communities. January 2022.
79. EPA. Memorandum Trichloroethylene: Fenceline Technical Support--
Water Pathway. March 24, 2023.
80. OMB. Memorandum for Guidance for Implementing Title II of the
Unfunded Mandates Reform Act (UMRA). March 31, 1995.
81. CPSC. Statutes. n.d. https://www.cpsc.gov/Regulations-Laws--Standards/Statutes.
82. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of
Trichloroethylene under TSCA Section 6(a); Proposed Rule (RIN 2070-
AK83). EPA ICR No. 2775.01. September 2023.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to OMB for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. EPA prepared an economic
analysis (Ref. 3) of the potential costs and benefits associated with
this action, which is available in the docket and is summarized in Unit
VI.D.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted to OMB under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2775.01 (Ref. 82). You can find a copy of the
ICR in the docket for this rulemaking, and it is briefly summarized
here.
There are two primary provisions of the proposed rule that may
increase burden under the PRA. The first is downstream notification,
which would be carried out by updates to the relevant SDS and which
would be required for manufacturers, processors, and distributors in
commerce of TCE, who would provide notice to companies downstream upon
shipment of TCE about the prohibitions. The information submitted to
downstream companies through the SDS would provide knowledge and
awareness of the restrictions to these companies. The second primary
provision of the proposed rule that may increase burden under the PRA
is WCPP-related information generation, recordkeeping, and notification
requirements (including development of exposure control plans; exposure
level monitoring and related recordkeeping; development of
documentation for a PPE program and related recordkeeping; development
of documentation for a respiratory protection program and related
recordkeeping; development and notification to potentially exposed
persons (employees and others in the workplace) about how they can
access the exposure control plans, exposure monitoring records, PPE
program implementation documentation, and respirator program
documentation; and development of documentation demonstrating
eligibility for an exemption from the proposed prohibitions, and
related recordkeeping).
Respondents/affected entities: Persons that manufacture (including
import), process, distribute in commerce, use, or dispose of TCE or
products containing TCE. See also Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
Estimated number of respondents: 22,113.
Frequency of response: On occasion.
Total estimated burden: 12,197 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $1,702,625 (per year), includes $722,586
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information
[[Page 74781]]
unless it displays a currently valid OMB control number. The OMB
control numbers for certain EPA regulations in 40 CFR are listed in 40
CFR part 9 and displayed on the form and instructions or collection
portal, as applicable.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this proposed rule. EPA will respond to ICR-related
comments in the final rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at https://www.reginfo.gov/public/do/PRAMain. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. OMB must receive comments
no later than November 30, 2023.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an initial regulatory flexibility analysis (IRFA) (Ref. 33)
that examines the impact of the proposed rule on small entities along
with regulatory alternatives that could minimize that impact. The
complete IRFA is available for review in the docket and is summarized
here.
1. Need for the Rule
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other nonrisk factors, including an
unreasonable risk to a PESS identified as relevant to the risk
evaluation, under the conditions of use, EPA must by rule apply one or
more requirements listed in TSCA section 6(a) to the extent necessary
so that the chemical substance or mixture no longer presents such risk.
TCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A)
that was issued in November 2020. In addition, in January 2023, EPA
issued a revised unreasonable risk determination that TCE as a whole
chemical substance presents an unreasonable risk of injury to health
under the conditions of use. As a result, EPA is proposing to take
action to the extent necessary so that TCE no longer presents such
risk.
2. Objectives and Legal Basis
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk. EPA has determined through a TSCA section
6(b) risk evaluation that TCE presents an unreasonable risk under the
conditions of use.
3. Description and Number of Small Entities to Which the Rule Will
Apply
The proposed rule potentially affects small manufacturers
(including importers), processors, distributors, retailers, users of
TCE or of products containing TCE, and entities engaging in disposal.
EPA estimates that the proposal would affect approximately 22,113
overall firms, of which 21,571 small entities have estimated impacts.
End users with economic and technologically feasible alternatives are
estimated to only incur costs associated with rule familiarization.
4. Projected Compliance Requirements
To address the unreasonable risk EPA has identified, EPA is
proposing to: Prohibit the manufacture (including import), processing,
and distribution in commerce of TCE for all uses (including all
consumer uses), with longer timeframes for manufacture and processing
related to certain uses; prohibit the industrial and commercial use and
distribution in commerce of TCE, with longer timeframes for certain
uses; prohibit the manufacture (including import) and processing of TCE
as an intermediate for the manufacture of HFC 134-a, following an 8.5-
year phaseout; prohibit the industrial and commercial use of TCE as a
solvent for closed-loop batch vapor degreasing for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, following a 10-year phaseout; prohibit
the manufacturing (including import), processing, distribution in
commerce, and use of TCE as a processing aid for battery separator
manufacturing following a 10-year TSCA section 6(g) exemption; prohibit
the manufacturing (including import), processing, distribution in
commerce, and use of TCE as a laboratory chemical (specifically in lab
use essential for essential laboratory activities) following a 50-year
TSCA section 6(g) exemption; Require strict workplace controls,
including a TCE workplace chemical protection program (WCPP), which
would include requirements for an inhalation exposure limit and glove
requirements to limit dermal exposure to TCE, for conditions of use
with long term phaseouts or time-limited exemptions under TSCA section
6(g); prohibit disposal to industrial pre-treatment, industrial
treatment, or publicly owned treatment works following a 50-year TSCA
section 6(g) exemption for cleanup projects; and establish
recordkeeping and downstream notification requirements.
EPA is proposing to prohibit all conditions of use. EPA is
proposing longer timeframes (with workplace controls) for prohibitions
on certain conditions of use. For the reasons described in Unit V., EPA
notes that long-term implementation of the WCPP is not a feasible means
of addressing unreasonable risk and that prohibition of the COUs is
ultimately necessary to address the unreasonable risk. Furthermore,
when selecting among proposed prohibitions and other restrictions that
would apply to those occupational conditions of use, EPA has also
factored in considerations relating to health effects on PESS,
including older pregnant women (the group identified as most
susceptible to fetal cardiac defects), further discussed in Unit VI.A.
EPA is proposing a WCPP for several conditions of use of TCE in order
to address to the extent possible the unreasonable risk during the time
period before a prohibition becomes effective. The WCPP would include
the ECEL, the associated implementation requirements, and may include
other components, such as dermal protection.
As described in Unit V.A., the TCE WCPP would be non-prescriptive,
in the sense that regulated entities would not be required to use
specific controls prescribed by EPA to achieve the exposure
concentration limit. Rather, it would be a performance-based exposure
limit that would enable owners or operators to determine how to most
effectively meet the exposure limit based on conditions at their
workplace.
A central component of the TCE WCPP is the exposure limit.
Exposures remaining at or below the ECEL would address any unreasonable
risk of injury to health driven by inhalation exposures for
occupational conditions of use in the TSCA 2020 Risk Evaluation. For
TCE, EPA is proposing an ECEL of 0.0011 parts per million (ppm) (0.0059
mg/m\3\) for inhalation exposures to TCE as an 8-hour TWA. As discussed
in Unit V.A.2.b.i., EPA acknowledges the challenges of complying with
the WCPP due to suitable personal breathing zone monitoring methods to
detect TCE air concentration levels at the ECEL, and requests comment
on using OSHA
[[Page 74782]]
Method 1001 to set an interim exposure limit.
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL for all potentially exposed persons,
EPA is proposing to require implementation of a PPE program in
alignment with OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132. Consistent with 29 CFR 1910.132, owners
and operators would be required to provide PPE, including respiratory
protection and dermal protection selected in accordance with the
guidelines described in this unit, that is of safe design and
construction for the work to be performed. EPA is proposing to require
owners and operators ensure each potentially exposed person who is
required by this unit to wear PPE to use and maintain PPE in a
sanitary, reliable, and undamaged condition. Owners and operators would
be required to select and provide PPE that properly fits each
potentially exposed person who is required by this unit to use PPE and
communicate PPE selections to each affected person.
As described further in Unit VI., EPA believes that long-term
implementation of the WCPP for continued use of TCE is not a feasible
means of addressing unreasonable risk such that prohibition may
ultimately be necessary to address the unreasonable risk.
EPA is not proposing reporting requirements beyond downstream
notification (third-party notifications). Regarding recordkeeping
requirements, three primary provisions of the proposed rule relate to
recordkeeping. The first is recordkeeping of general records: all
persons who manufacture, process, distribute in commerce, or engage in
industrial or commercial use of TCE or TCE-containing products must
maintain ordinary business records, such as invoices and bills-of-
lading related to compliance with the prohibitions, restrictions, and
other provisions of the regulation.
The second is recordkeeping related to WCPP compliance: under the
proposed regulatory action, facilities complying with the rule through
the WCPP would be required to develop and maintain records associated
with ECEL exposure monitoring (including measurements, compliance with
Good Laboratory Practice Standards, and information regarding
monitoring equipment); compliance with the ECEL or lowest achievable
exposure level (including the exposure control plan, PPE program
implementation, and workplace information and training); PPE compliance
(including the exposure control plan, PPE program implementation, basis
for specific PPE selection, and workplace information and training);
and workplace participation. This would also include recordkeeping
related to the exemptions proposed under TSCA section 6(g), which would
provide longer compliance dates for entities engaged in specific
activities with TCE for which prohibition in the short term would be
disruptive to national security or critical infrastructure. To maintain
eligibility for the time-limited exemptions, EPA is proposing that
owners and operators maintain records demonstrating compliance with the
specific conditions of the exemption, including compliance with the
WCPP by meeting the ECEL to the extent possible. To support and
demonstrate compliance, EPA is proposing that each owner or operator of
a workplace subject to the WCPP retain compliance records for five
years.
The third is recordkeeping related to the phaseouts for processing
TCE in manufacture of HFC-134a (for which each manufacturer of HFC-134a
who uses TCE as an intermediate would be required to maintain
production volume records demonstrating compliance with setting the
baseline and the phaseout) or use as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring (for which each person using
TCE would be required to maintain records demonstrating that the end
use is for rocket booster nozzle production for Federal agencies and
their contractors and would, within five years, be required to maintain
records that demonstrate that a final pre-launch test of rocket booster
nozzles was completed without using TCE in the production of rocket
booster nozzles for Federal agencies and their contractors).
a. Classes of Small Entities Subject to the Compliance Requirements
The small entities that would be potentially directly regulated by
this rulemaking are small entities that manufacture (including import),
process, distribute in commerce, use, or dispose of TCE, including
retailers of TCE for end-consumer uses.
b. Professional Skills Needed To Comply
Entities that would be subject to this proposal that manufacture
(including import), process, or distribute TCE in commerce would be
required to cease under the proposed rule. The entity would be required
to modify their SDS or develop another way to inform their customers of
the prohibition on manufacture, processing, and distribution of TCE.
They would also be required to maintain ordinary business records, such
as invoices and bills-of-lading, that demonstrate compliance with the
prohibitions, restrictions, and other provisions of this proposed
regulation. These are all routine business tasks that do not require
specialized skills or training.
Entities that use TCE in any industrial and commercial capacity
would be required to cease under the proposed rule, with some
timeframes for prohibitions longer than others. Restriction or
prohibition of these uses would likely require the implementation of an
alternative chemical or the cessation of use of TCE in a process or
equipment that may require persons with specialized skills, such as
engineers or other technical experts. Instead of developing an
alternative method themselves, commercial users of TCE may choose to
contract with another entity to do so.
Entities that would be permitted to continue on a time-limited
basis until prohibition to manufacture, process, distribute, or use TCE
would be required to implement a WCPP and would have to attempt to meet
the provisions of the program to the extent possible for continued use
of TCE. A transition to a WCPP may require persons with specialized
skills such as an engineer or health and safety professional. Instead
of implementing the WCPP to the extent possible, entities that use TCE
may choose to contract with another entity to do so. Records would have
to be maintained for compliance with a WCPP by meeting the ECEL to the
extent possible. While this recording activity itself may not require a
special skill, the information to be measured and recorded may require
persons with specialized skills such as an industrial hygienist.
5. Relevant Federal Rules
Because of its health effects, TCE is subject to numerous State,
Federal, and international regulations restricting and regulating its
use. The following is a summary of the regulatory actions pertaining to
TCE; for a full description see appendix A of the 2020 Risk Evaluation
for TCE and the summary in the docket (Ref. 9).
EPA has published numerous rules and Federal Register documents
pertaining to TCE under its various authorities.
Under a Significant New Use Rule (SNUR), (81 FR 20535, April 8,
2016), issued under the authority of TSCA section 5(a), TCE is subject
to notifications for manufacture (including import) or processing of
TCE for use in
[[Page 74783]]
a consumer product except for use in cleaners and solvent degreasers,
film cleaners, hoof polishes, lubricants, mirror edge sealants and
pepper spray. This SNUR ensures that EPA will have the opportunity to
review any new consumer uses of TCE and, if appropriate, take action to
prohibit or limit those uses.
The TSCA section 8(a) Chemical Data Reporting (CDR) Rule requires
manufacturers (including importers) to give EPA basic exposure-related
information on the types, quantities and uses of chemical substances
produced domestically and imported into the United States. TCE
manufacturing (including importing), processing, and use information is
reported under the CDR rule (76 FR 50816, August 16, 2011).
TCE is a hazardous air pollutant under the CAA (42 U.S.C.
7412(b)(1)). Under section 112(d), EPA has established national
emission standards for hazardous air pollutants (NESHAPs) for a number
of source-specific categories that emit TCE, including synthetic
organic chemical manufacturing (40 CFR part 63, subparts F, G, and H),
miscellaneous organic chemical manufacturing (40 CFR part 63, subpart
FFFF), and aerospace manufacturing and rework facilities (40 CFR part
63, subpart GG). Under sections 112(d) and 112(f), EPA has promulgated
a number of risk and technology review (RTR) NESHAPs, including the RTR
NESHAP for Halogenated Solvent Cleaning (40 CFR part 63, subpart T).
With this proposed rule under TSCA section 6, uses and emissions
already regulated under these NESHAPs would be prohibited, with some of
these uses identified for a longer phaseout timeframe under TSCA
section 6.
Under the CAA section 612, EPA's Significant New Alternatives
Policy (SNAP) program listed TCE as an acceptable substitute for methyl
chloroform and chlorofluorocarbon (CFC)-113 in metals, electronics, and
precision cleaning; as an alternative to CFC-11, CFC-113, methyl
chloroform, and hydrochlorofluorocarbon (HCFC)-141b for aerosol solvent
use; and as an alternative for methyl chloroform for use as a carrier
solvent in adhesives, coatings, and inks (59 FR 13044, March 18, 1994).
TCE was also noted to have essentially no ozone depletion potential and
cited as a volatile organic compound (VOC)-exempt solvent and
acceptable substitute for ozone-depleting substances (72 FR 30142, May
30, 2007). TCE is also listed under the National Volatile Organic
Compound Emission Standards for Aerosol Coatings (40 CFR part 59,
subpart E). Under the American Innovation and Manufacturing Act (AIM
Act) that directs EPA to phase down the production and consumption of
HFCs, EPA set HFC production and consumption baseline levels from which
reductions will be made (86 FR 55116, October 5, 2021). The rule also
establishes an initial methodology for allocating and trading HFC
allowances for 2022 and 2023. TCE is identified as a feedstock chemical
for HFC production, specifically HFC-134a.
TCE is designated as a toxic pollutant under section 307(a)(1) of
the Clean Water Act and as such is subject to effluent limitations.
Also under section 304, TCE is included in the list of total toxic
organics (TTO) (40 CFR 413.02(i)). In 2015, EPA published updated
ambient water quality criteria for TCE, including recommendations for
``water + organism'' and ``organism only'' human health criteria for
States and authorized tribes to consider when adopting criteria into
their water quality standards (80 FR 36986, June 29, 2015). TCE is also
subject to National Primary Drinking Water Regulations (NPDWR) under
the Safe Drinking Water Act (SDWA) with a maximum contaminant level
goal (MCGL) of zero and an enforceable maximum contaminant level (MCL)
of 0.005 mg/L (40 CFR 141.50; 40 CFR 141.61).
Programs within EPA implementing other environmental statutes,
including, but not limited to, the RCRA, the Comprehensive
Environmental Response, Compensation and Liability Act, the Safe
Drinking Water Act, and the CWA, classify TCE as a characteristic and
listed hazardous waste (40 CFR 261.24, 40 CFR 261.31, 40 CFR
261.33(f)). In 2013, EPA modified its hazardous waste management
regulations to conditionally exclude solvent-contaminated wipes that
have been cleaned and reused from the definition of solid waste under
RCRA and to conditionally exclude solvent-contaminated wipes that are
disposed from the definition of hazardous waste (78 FR 46448, July 31,
2013). However, TCE-contaminated wipes were not eligible for this
exclusion due to health and safety concerns.
EPA notes that TCE was first registered as an antimicrobial and
conventional chemical in 1985 pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). TCE is not currently used in
pesticides, either as an active or inert ingredient. While TCE was
previously used as an inert, EPA removed TCE from its list of inert
ingredients used in pesticide products in 1998 (63 FR 34384, June 24,
1998).
While TSCA shares equity in the regulation of TCE, EPA does not
anticipate this rulemaking to duplicate nor conflict with the
aforementioned programs' classifications and associated rules.
In addition to EPA actions, TCE is also subject to other Federal
regulations. Under the OSH Act, OSHA established the PEL for TCE at 100
ppm as an 8-hour TWA with an acceptable ceiling concentration of 200
ppm and an acceptable maximum peak above the acceptable ceiling
concentration for an 8-hour shift of 300 ppm, maximum duration of 5
minutes in any 2 hours (29 CFR 1910.1000). However, EPA recognizes that
the existing PEL does not eliminate the unreasonable risk identified by
EPA under TSCA, and EPA is therefore proposing prohibitions based on
the unreasonable risk identified following the TSCA 2020 Risk
Evaluation for TCE, with time-limited requirements to meet to the
extent possible a new, lower exposure limit. The implementation of
those requirements would align with existing OSHA requirements where
possible. For TCE, this approach would eliminate the unreasonable risk
driven by certain conditions of use, reduce burden for complying with
the regulations, and provide the familiarity of a pre-existing
framework for the regulated community.
Under the FFDCA, the Food and Drug Administration established
tolerances for residues of TCE resulting from its use as a solvent in
the manufacture of decaffeinated coffee and spice oleoresins (21 CFR
173.290). Under the Atomic Energy Act, the Department of Energy Worker
Safety and Health Program requires its contractor employees to use the
2005 ACGIH TLV for TCE, which is 10 ppm (8-hour TWA) and 25 ppm Short
Term Exposure Limit. Under the Federal Hazardous Material
Transportation Act, the Department of Transportation has designated TCE
as a hazardous material, and there are special requirements for
marking, labeling, and transporting it (49 CFR part 171, 49 CFR part
172, 40 CFR 173.202, and 40 CFR 173.242).
6. Significant Alternatives to the Proposed Rule
EPA analyzed alternative regulatory approaches to identify which
would be feasible, reduce burden to small businesses, and achieve the
objective of the statute (i.e., applying one or more requirements
listed in TSCA section 6(a) to the extent necessary so that the
chemical substance or mixture no longer presents an unreasonable risk).
As
[[Page 74784]]
described in more detail in Unit V., EPA considered several factors, in
addition to identified unreasonable risk, when selecting among possible
TSCA section 6(a) requirements. To the extent practicable, EPA factored
into its decisions: the effects of TCE on health and the environment,
the magnitude of exposure to TCE of human beings and the environment,
the benefits of TCE for various uses, and the reasonably ascertainable
economic consequences of the rule. As part of this analysis, EPA
considered--in addition to the prohibitions described in Unit V.--a
wide variety of control measures to address the unreasonable risk from
TCE such as a WCPP, weight fractions, a certification and limited
access program, and prescriptive controls. EPA's analysis of these risk
management approaches is detailed in Unit V.A.3. In general, EPA
determined that these approaches alone would either not be able to
address the unreasonable risk, or, in the case of a weight fraction
limit, would result in a product containing so little TCE that it would
have the effect of a prohibition.
Additionally, in this proposed rule and the Economic Analysis, EPA
has examined a primary alternative regulatory action. The primary
alternative regulatory action described in this proposed rule and
considered by EPA combines prohibitions and requirements for a WCPP.
While in some ways it is similar to the proposed regulatory action, the
primary alternative regulatory action described in this NPRM differs
from the proposed regulatory action by providing longer timeframes for
prohibitions and by describing an ECEL based on a different health
endpoint (i.e., immunotoxicity), as part of the WCPP, for the
conditions of use of TCE that would be permitted to continue for longer
than 1 year after publication of the final rule until the prohibition
compliance dates. The primary alternative regulatory action was
considered and found to provide greater uncertainty in addressing the
unreasonable risk from TCE under the conditions of use, resulting in
EPA's proposed action. Estimated costs of the primary alternative
regulatory action can be found in Chapter 7 of the Economic Analysis
(Ref. 3).
As indicated by this overview, and detailed in Unit VI.A., in the
review of alternatives, EPA determined that some methods either did not
effectively eliminate the unreasonable risk presented by TCE or, for
many conditions of use, there was a high degree of uncertainty
regarding whether compliance with a comprehensive WCPP would be
possible to adequately protect potentially exposed persons. While EPA
is soliciting comments about all aspects on the alternative regulatory
actions, which may be incorporated into the final rulemaking, EPA has
considered the primary alternative regulatory action and found that the
proposed action is more suitable for addressing the unreasonable risk
to the extent necessary so that TCE no longer presents such risk, while
also allowing flexibility for regulated entities to continue operations
under time-limited exemptions, as described in more detail in Units
V.A. and VI.A.
Regarding timeframes for compliance, as described in Units V.A.1.,
2., and 3., the proposed compliance dates incorporate EPA's
consideration of sustained awareness of risks resulting from TCE
exposure as well as precedent established by the OSHA standards (62 FR
1494, January 10, 1997). TSCA requires that EPA propose timeframes that
are ``as soon as practicable'' under TSCA section 6(d)(1)(B) and
6(d)(1)(D). EPA has no information indicating that the proposed
compliance dates are not practicable for the activities that would be
prohibited, or that additional time is needed for products affected by
the proposed restrictions to clear the channels of trade. As noted in
Unit IX., EPA is seeking public comment on whether additional time is
needed for compliance with prohibitions, for products to clear the
channels of trade, or for implementing a WCPP. EPA may finalize shorter
or longer compliance timeframes based on public comment. Regarding
potential regulatory flexibilities for compliance dates and timeframes,
EPA notes that the alternative regulatory action would include longer
compliance timeframes for prohibitions. Given the potential severity of
impacts from exposure to TCE, EPA's proposed regulatory action would
include relatively rapid compliance timeframes. However, it is possible
that longer timeframes would be needed for entities to come into
compliance; therefore, the primary alternative regulatory action
described in the proposed rule would include longer timeframes for
implementation than the proposed regulatory action. These timeframes
are detailed in Unit V.B.
As required by section 609(b) of the RFA, the EPA also convened a
SBAR Panel to obtain advice and recommendations from SERs that
potentially would be subject to the rule's requirements. The SBAR Panel
evaluated the assembled materials and small-entity comments on issues
related to elements of an IRFA. A copy of the full SBAR Panel Report
(Ref. 32) is available in the rulemaking docket.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain a Federal mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action would
affect entities that use TCE. It is not expected to affect State,
local, or Tribal governments because the use of TCE by government
entities is minimal. This action is not expected to result in
expenditures by State, local, and Tribal governments, in the aggregate,
or by the private sector, of $100 million or more (when adjusted
annually for inflation) in any 1 year. Accordingly, this action is not
subject to the requirements of sections 202, 203, or 205 of UMRA.
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulations under TSCA section 6(a) may preempt State law. As
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA
section 6(a) to address the unreasonable risk presented by a chemical
substance has the potential to trigger preemption of laws, criminal
penalties, or administrative actions by a State or political
subdivision of a State that are: (1) Applicable to the same chemical
substance as the rule under TSCA section 6(a); and (2) Designed to
prohibit or otherwise restrict the manufacture, processing, or
distribution in commerce or use of that same chemical. TSCA section
18(c)(3) applies that preemption only to the ``hazards, exposures,
risks, and uses or conditions of use'' of such chemical included in the
final TSCA section 6(a) rule.
EPA provides the following preliminary federalism summary impact
statement. The Agency consulted with State and local officials early in
the process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included
background presentation on September 9, 2020, and a consultation
meeting on July 22, 2021. EPA invited the following national
organizations representing State and local elected officials to these
meetings: Association of State Drinking Water Administrators, National
Association of Clean Water Agencies, Western States Water Council,
National Water Resources Association, American Water Works Association,
Association of Metropolitan Water Agencies,
[[Page 74785]]
Association of Clean Water Administrators, Environmental Council of the
States, National Association of Counties, National League of Cities,
County Executives of America, U.S. Conference of Mayors, and National
Association of Attorneys General. As described in Unit III.A.1., during
the meeting participants and EPA discussed preemption; the authority
given under TSCA section 6 to regulate identified unreasonable risk;
which activities would be potentially regulated in the proposed rule;
TSCA reporting requirements; key local constituencies; and the
relationship between TSCA and existing statutes, particularly the CWA
and SDWA. A summary of the meeting with these organizations, including
the views that they expressed, is available in the docket (Ref. 26).
EPA provided an opportunity for these organizations to provide follow-
up comments in writing but did not receive any such comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. This rulemaking would not have
substantial direct effects on Tribal government because TCE is not
manufactured, processed, or distributed in commerce by Tribes. TCE is
not regulated by Tribes, and this rulemaking would not impose
substantial direct compliance costs on Tribal governments. Thus,
Executive Order 13175 does not apply to this action.
Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, EPA consulted with Tribal officials during the
development of this action. The Agency held a Tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15, 2021, and
July 8, 2021. Tribal officials were given the opportunity to
meaningfully interact with EPA risk managers concerning the current
status of risk management. During the consultation, EPA discussed risk
management under TSCA section 6(a). EPA risk managers briefed Tribal
officials on the Agency's risk management considerations and Tribal
officials raised issues and concerns. Issues raised by Tribal officials
included concerns from Tribal members about the TCE OSHA exposure
limits being outdated, Tribal interest in seeing TCE phased out and an
interest in reducing greenhouse gas emissions, and concerns that third
party disposal may be occurring near Tribal lands, with a particular
interest in protecting workers at publicly owned treatment works.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. While the environmental
health or safety risks addressed by this action present a
disproportionate risk to children due to TCE's developmental toxicity,
this action is not subject to Executive Order 13045 because it is not a
significant regulatory action under section 3(f)(1) of Executive Order
12866.
However, EPA's 2021 Policy on Children's Health applies to this
action. Information on how the Policy was applied is presented in Unit
III.A.3. In addition, this action's health and risk assessments are
contained in Units III.B.2., VI.A. and B., and the 2020 Risk Evaluation
for TCE (section 4 in Ref. 1) and the Economic Analysis for this
proposed rulemaking (Ref. 3).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy.
I. National Technology Transfer and Advancement Act (NTTAA)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to TCE.
Consistent with the Agency's Performance Based Measurement System
(PBMS), the Agency proposes not to require the use of specific,
prescribed analytic methods. Rather, the Agency plans to allow the use
of any method that meets the prescribed performance criteria. The PBMS
approach is intended to be more flexible and cost-effective for the
regulated community; it is also intended to encourage innovation in
analytical technology and improved data quality. EPA is not precluding
the use of any method, whether it constitutes a voluntary consensus
standard or not, as long as it meets the performance criteria
specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
TCE at the ECEL and the ECEL action level. Some examples of methods
which meet the criteria are included in appendix B of the ECEL memo
(Ref. 46). EPA recognizes that there may be voluntary consensus
standards that meet the proposed criteria (Ref. 12). EPA request
comments on whether it should incorporate such voluntary consensus
standards in the rule and seeks information in support of such comments
regarding the availability and applicability of voluntary consensus
standards that may achieve the sampling and analytical requirements of
the rule in lieu of the PBMS approach.
EPA requests comment on the degree to which additional guidance
related to use of methods might be necessary.
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionate and adverse human health or environmental effects on
communities with environmental justice concerns. As described more
fully in the Economic Analysis, EPA conducted an analysis to
characterize the baseline conditions faced by communities and workers
affected by the regulation to identify the potential for
disproportionate impacts on communities with EJ concerns in accordance
with Executive Order 12898 (59 FR 7629, February 16, 1994) and
Executive Order 14096 (88 FR 25251, April 26, 2023). The baseline
characterization suggests that workers in affected industries and
regions, as well as residents of nearby communities, are more likely to
be people of color than the general population in affected states,
although this varied by use assessed. Based on reasonably available
information, EPA believes that there are potential EJ concerns in
communities surrounding facilities subject to this regulation (Ref. 3).
EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on communities with
[[Page 74786]]
environmental justice concerns. While the regulatory options are
anticipated to address the unreasonable risk from exposure to TCE to
the extent necessary so that it is no longer unreasonable, EPA is not
able to quantify the distribution of the change in risk for affected
populations. EPA is also unable to quantify the changes in risks for
affected populations from non-TCE-using technologies or practices that
firms may adopt in response to the regulation to determine whether any
such changes could pose EJ concerns. Data limitations that prevent EPA
from conducting a more comprehensive analysis are summarized in the
Economic Analysis (Ref. 3).
EPA additionally identified and addressed EJ concerns by conducting
outreach to advocates of communities that might be subject to
disproportionate exposure to TCE. On June 16, 2021, and July 6, 2021,
EPA held public meetings as part of this consultation (Ref. 32). See
also Unit III.A.1. Following the EJ meetings, EPA received five written
comments, in addition to oral comments provided during the
consultations. In general, commenters supported strong regulation of
TCE to protect lower-income communities and workers. Commenters
supported strong outreach to affected communities, encouraged EPA to
follow the hierarchy of controls, favored prohibitions, and noted the
uncertainty, and, in some cases, inadequacy, of PPE.
The information supporting the review under Executive Order 12898
and Executive Order 14096 is contained in Units I.E., II.D., III.A.1.,
VI.A., and in the Economic Analysis (Ref. 3). EPA's presentations and
fact sheets for the EJ consultations related to this rulemaking, are
available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These
materials and a summary of the consultation are also available in the
public docket for this rulemaking (Ref. 32).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 751 as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.5 by adding in alphabetical order definitions for
``Authorized person'', ``ECEL'', ``Exposure group'', ``Owner or
operator'', ``Potentially exposed person'', ``Regulated area'', and
``Retailer'' to read as follows:
Sec. 751.5 Definitions.
* * * * *
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter a regulated area.
* * * * *
ECEL is an Existing Chemical Exposure Limit and means an airborne
concentration calculated as an eight (8)-hour time-weighted average
(TWA).
* * * * *
Exposure group means a group consisting of every person performing
the same or substantially similar operations in each work shift, in
each job classification, and in each work area where exposure to
chemical substances or mixtures is reasonably likely to occur.
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
* * * * *
Potentially exposed person means any person who may be
occupationally exposed to a chemical substance or mixture in a
workplace as a result of a condition of use of that chemical substance
or mixture.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the ECEL or the EPA STEL.
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Any distributor
with at least one consumer end user customer is considered a retailer.
A person who distributes in commerce or makes available a chemical
substance or mixture solely to commercial or industrial end users or
solely to commercial or industrial businesses is not considered a
retailer.
0
2. Add new subpart D to read as follows:
Subpart D--Trichloroethylene
Sec.
751.301 General.
751.303 Definitions.
751.305 Prohibitions of manufacturing, processing, distribution in
commerce, use and disposal.
751.307 Phaseout of trichloroethylene use in manufacture of HFC-
134a.
751.309 Phaseout of trichloroethylene use in vapor degreasing for
booster rocket nozzles.
751.311 Workplace chemical protection program.
751.313 Downstream notification.
751.315 Recordkeeping requirements.
751.317 Exemptions.
Sec. 751.301 General.
This subpart establishes prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of trichloroethylene (TCE) (CASRN 79-01-6) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
Sec. 751.303 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec. 751.313 and 751.315.
ECEL action level means a concentration of airborne TCE of 0.00055
parts per million (ppm) calculated as an eight (8)-hour time-weighted
average (TWA).
Sec. 751.305 Prohibitions of manufacturing, processing, distribution
in commerce, use and disposal.
(a) Applicability. The provisions of this section apply to the
following:
(1) Manufacturing (including importing);
(2) Processing;
(3) All industrial and commercial uses;
(4) All consumer uses;
(5) Distribution in commerce; and
(6) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works.
(b) Prohibitions. (1) After [DATE 3 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are
prohibited from manufacturing (including importing)
[[Page 74787]]
TCE, except as specified in paragraphs (b)(4) through (13) of this
section.
(2) After [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
processing and distributing in commerce (including making available)
TCE, including any TCE-containing products, except as specified in
paragraphs (b)(4) through (13) of this section.
(3) After [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
industrial and commercial use of TCE, including any TCE-containing
products, except as specified in paragraphs (b)(4) through (13) of this
section.
(4) After [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
manufacturing (including importing) TCE for industrial and commercial
use for batch vapor degreasing in open-top and closed-loop degreasing
equipment, except for the use specified in paragraphs (b)(9) and (11)
of this section.
(5) After [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
processing TCE for industrial and commercial use for batch vapor
degreasing in open-top and closed-loop degreasing equipment, except for
the use specified in paragraphs (b)(9) and (11) of this section.
(6) After [DATE 1 YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER], all persons are prohibited from the
industrial and commercial use of TCE for batch vapor degreasing in
open-top and closed-loop degreasing equipment, except for the use
specified in paragraphs (b)(9) and (11) of this section.
(7) After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
manufacturing (including importing) TCE for processing of TCE as a
reactant/intermediate and processing TCE for the industrial and
commercial use of TCE as a processing aid for: battery separator
manufacturing; process solvent used in polymer fiber spinning,
fluoroelastomer manufacture and Alcantara manufacture; extraction
solvent used in caprolactam manufacture; precipitant used in beta-
cyclodextrin manufacture, except for those uses specified in paragraphs
(b)(10) and (12) of this section.
(8) After [DATE 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER], all persons are prohibited from processing
TCE as a reactant/intermediate and from processing TCE for the
industrial and commercial use of TCE as a processing aid in: process
solvent used in battery manufacture; process solvent used in polymer
fiber spinning, fluoroelastomer manufacture and Alcantara manufacture;
extraction solvent used in caprolactam manufacture; precipitant used in
beta-cyclodextrin manufacture, except for those uses specified in
paragraphs (b)(10) and (12) of this section.
(9) After [DATE 5 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER] all persons are prohibited from the industrial
and commercial use of TCE as a solvent in closed-loop batch vapor
degreasing for rayon fabric scouring for end use in producing rocket
booster nozzles for Federal agencies and their contractors, and
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use, unless such persons obtain and maintain
the records required by Sec. 751.309 demonstrating that a final pre-
launch test was completed using an alternative to TCE in the production
of the rocket booster nozzles.
(10) After [DATE 8 YEARS AND 6 MONTHS AFTER DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited
from manufacturing (including import), distribution in commerce, and
processing of TCE as an intermediate for manufacturing
hydrofluorocarbon 134-a, also known as 1,1,1,2-Tetrafluroethane (HFC-
134a: CAS Number 811-97-2).
(11) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop batch
vapor degreasing for rayon fabric scouring for end use in producing
rocket booster nozzles for Federal agencies and their contractors, and
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use.
(12) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the
industrial and commercial use of TCE as a processing aid for battery
separatory manufacturing, and the manufacturing (including importing),
processing, and distribution in commerce of TCE for such use.
(13) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], for DoD naval vessels and their systems,
and in the maintenance, fabrication, and sustainment for and of such
vessels and systems, prohibit the industrial and commercial use of TCE
as potting compounds for naval electronic systems and equipment;
sealing compounds for high and ultra high vacuum systems; bonding
compounds for materials testing and maintenance of underwater systems
and bonding of nonmetallic materials; and cleaning requirements (which
includes degreasing using wipes, sprays, solvents and vapor degreasing)
for: materials and components required for military ordnance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes.
(14) After [DATE 50 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
industrial and commercial uses of TCE for the laboratory uses for
essential laboratory uses described in Sec. 751.317(b)(1), and from
the manufacturing (including importing), processing, and distribution
in commerce of TCE for such uses.
(15) After [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons manufacturing (including
importing), processing, and using TCE are prohibited from disposal of
TCE to industrial pre-treatment, industrial treatment, or publicly
owned treatment works except as specified in paragraph (b)(16) of this
section.
(16) After [DATE 50 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from disposal
of TCE to industrial pre-treatment, industrial treatment, or publicly
owned treatment works for the purposes of cleanup projects of TCE-
contaminated water and groundwater as described in Sec. 751.317(b)(2).
[[Page 74788]]
(17) After [DATE 7 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop vapor
degreasing necessary for human-rated rocket engine cleaning by NASA and
its contractors as described in Sec. 751.317(c)(3) and the
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use.
Sec. 751.307 Phaseout of trichloroethylene use in manufacture of HFC-
134a.
(a) Baseline. Before [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER], each manufacturer of HFC-134a
who processes TCE as an intermediate must establish a baseline annual
volume of TCE processed as an intermediate.
(1) The manufacturer must use the average of any 12 consecutive
months in the 36 months preceding [DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] to calculate the baseline.
(2) The manufacturer must retain records that demonstrate how the
baseline annual volume was calculated, in accordance with Sec.
751.315(d)(1).
(b) Phaseout. (1) Beginning [DATE 2 YEARS AND 6 MONTHS AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], each
manufacturer of HFC-134a who processes TCE as an intermediate is not
permitted to process TCE as an intermediate at an annual volume greater
than 75 percent of the baseline.
(2) Beginning [DATE 4 YEARS AND 6 MONTHS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], each manufacturer of HFC-
134a who processes TCE as an intermediate is not permitted to processes
TCE as an intermediate at an annual volume greater than 50 percent of
the baseline.
(3) Beginning [DATE 6 YEARS AND 6 MONTHS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], each manufacturer of HFC-
134a who processes TCE as an intermediate is not permitted to processes
TCE as an intermediate at an annual volume greater than 25 percent of
the baseline so established.
(4) Beginning [DATE 8 YEARS AND 6 MONTHS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], each manufacturer of HFC-
134a who processes TCE as an intermediate is prohibited from processing
TCE as an intermediate.
(c) Workplace chemical protection program. All persons using TCE in
accordance with this section must comply with Sec. 751.311.
Sec. 751.309 Phaseout of trichloroethylene use in vapor degreasing
for booster rocket nozzles.
(a) In accordance with Sec. 751.305(b)(9), until [DATE 5 YEARS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER],
TCE may be manufactured (including imported), processed, distributed in
commerce, and used as a solvent in closed-loop batch vapor degreasing
for rayon fabric scouring for end use in rocket booster nozzle
production by Federal agencies and their contractors.
(b) From [DATE 5 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER] until [DATE 10 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], TCE may only be
manufactured (including imported), processed, distributed in commerce,
and used as a solvent in closed-loop batch vapor degreasing for rayon
fabric scouring, for end use in rocket booster nozzle production by
Federal agencies and their contractors by persons who maintain records
demonstrating that a final pre-launch test of rocket booster nozzles
without using TCE was completed.
(c) All persons using TCE in accordance with this section must
comply with Sec. 751.311.
Sec. 751.311 Workplace chemical protection program.
(a) Applicability. The provisions of this section apply to
workplaces engaged in the following conditions of use of TCE that are
allowed to temporarily continue past one year, in accordance with Sec.
751.305(b)(4) through (13), Sec. 751.307, and Sec. 751.309:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing as a reactant/intermediate;
(4) Processing into formulation, mixture or reaction product;
(5) Processing (repackaging);
(6) Processing (recycling);
(7) Industrial and commercial use as a processing aid in process
solvent used in battery manufacture; process solvent used in polymer
fiber spinning, fluoroelastomer manufacture and Alcantara manufacture;
extraction solvent used in caprolactam manufacture; precipitant used in
beta-cyclodextrin manufacture;
(8) Industrial and commercial use in other miscellaneous industrial
and commercial uses (laboratory use for essential laboratory
activities);
(9) Industrial and commercial use of TCE as a solvent in closed-
loop batch vapor degreasing for rayon fabric scouring for end use in
rocket booster nozzle production by Federal agencies and their
contractors;
(10) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purposes of
cleanup projects of TCE-contaminated water and groundwater;
(11) Industrial and commercial use of TCE for DoD naval vessels and
their systems, and in the maintenance, fabrication, and sustainment for
and of such vessels and systems; as potting compounds for naval
electronic systems and equipment; sealing compounds for high and ultra
high vacuum systems; bonding compounds for materials testing and
maintenance of underwater systems and bonding of nonmetallic materials;
and cleaning requirements (which includes degreasing using wipes,
sprays, solvents and vapor degreasing) for: materials and components
required for military ordnance testing; temporary resin repairs in
vessel spaces where welding is not authorized; ensuring polyurethane
adhesion for electronic systems and equipment repair and installation
of elastomeric materials; various naval combat systems, radars,
sensors, equipment; fabrication and prototyping processes to remove
coolant and other residue from machine parts; machined part
fabrications for naval systems; installation of topside rubber tile
material aboard vessels; and vapor degreasing required for substrate
surface preparation prior to electroplating processes; and
(12) Industrial and commercial use of TCE as a solvent in closed-
loop vapor degreasing necessary for human-rated rocket engine cleaning
by NASA and its contractors.
(b) Existing chemical exposure limit (ECEL). (1) Applicability. The
provisions of this paragraph (b) apply to any workplace engaged in the
conditions of use listed in paragraphs (a)(1) through (9) of this
section.
(2) ECEL. Beginning [DATE 9 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], or beginning 4 months after
introduction of TCE into the workplace if TCE use commences after [DATE
6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], the owner or operator must ensure to the extent possible
that no person is exposed to an airborne
[[Page 74789]]
concentration of TCE in excess of 1.1 parts of TCE per billion parts of
air (0.0011 ppm) as an eight (8)-hour TWA, in accordance with the
requirements of paragraph (c) of this section and, if necessary,
paragraph (e) of this section:
(3) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each person whose exposure must be
monitored.
(B) Representative 8-hour TWA exposures must be determined on the
basis of one or more full-shift exposure of at least one person that
represents, and does not underestimate, the potential exposure of every
person in each exposure group and that represents the highest TCE
exposures likely to occur under reasonably foreseeable conditions of
use.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice Standards in 40 CFR part 792.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of TCE.
(ii) Initial monitoring. (A) Each owner or operator who has a
workplace or work operation covered by this section, except as provided
for in paragraph (b)(3)(ii)(B) of this section, must perform initial
monitoring of potentially exposed persons regularly working in areas
where TCE is present.
(B) The initial monitoring required in paragraph (b)(3)(ii)(A) of
this section must be completed by [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or within 30
days of introduction of TCE into the workplace, whichever is later.
Where the owner or operator has monitoring within five years prior to
[DATE 2 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER] and the monitoring satisfies all other requirements
of this section, the owner or operator may rely on such earlier
monitoring results to satisfy the requirements of paragraph
(b)(3)(ii)(A) of this section.
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to TCE
in accordance with Table 1 to this paragraph (b)(3)(iii).
Table 1 to Paragraph (b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below the ECEL action level (<0.00055 required at least once every 5
ppm 8-hour TWA). years.
If the initial or most recent exposure Periodic exposure monitoring is
monitoring indicates that airborne required within 3 months of
exposure is above the ECEL (>0.0011 the most recent exposure
ppm 8-hour TWA). monitoring.
If the initial or most recent exposure Periodic exposure monitoring is
monitoring indicates that airborne required within 6 months of
exposure is at or above the ECEL the most recent exposure
action level but at or below the ECEL monitoring.
(>=0.00055 ppm 8-hour TWA, <=0.0011
ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within 5 years of the
taken at least seven days apart, most recent exposure
indicate that airborne exposure is monitoring.
below the ECEL action level (<0.00055
ppm 8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which compliance its current periodic
with the WCPP would be required but monitoring event. However,
does not manufacture, process, use, or documentation of cessation of
dispose of TCE in that condition of use of TCE as well as periodic
use over the entirety of time since monitoring would be required
the last required monitoring event. when the owner or operator
resumes any of the conditions
of use for which compliance
with the WCPP is proposed.
------------------------------------------------------------------------
(iv) Additional monitoring. (A) The owner or operator must conduct
additional initial exposure monitoring whenever there has been a change
in the production, process, control equipment, personnel or work
practices that may reasonably be expected to result in new or
additional exposures above the ECEL action level or when the owner or
operator has any reason to believe that new or additional exposures
above the ECEL action level have occurred.
(B) Whenever start-ups, shutdown, spills, leaks, ruptures, or other
breakdowns occur that may lead to exposure to potentially exposed
persons, the owner or operator must conduct additional initial exposure
monitoring (using personal breathing zone sampling) after the cleanup
of the spill or repair of the leak, rupture, or other breakdown.
(v) Notification of monitoring results. (A) The owner or operator
must inform persons whose exposures are represented by the monitoring
of the monitoring results within 15 working days.
(B) This notification must include the following:
(1) Exposure monitoring method(s) and results;
(2) Identification and explanation of the ECEL and ECEL action
level in plain language;
(3) Any corresponding required respiratory protection as described
in paragraph (e) of this section;
(4) Descriptions of actions taken by the regulated entity to reduce
exposure to or below the ECEL;
(5) Quantity of TCE in use;
(6) Location of TCE use;
(7) Manner of TCE use;
(8) Identified releases of TCE; and
(9) Whether the airborne concentration of TCE exceeds the ECEL.
(C) Notice must be provided in plain language writing, in a
language that the person understands, to each potentially exposed
person or posted in an appropriate and accessible location outside the
regulated area with an English-language version and a non-English
language version representing the language of the largest group of
workers who do not read English.
(4) Regulated areas. (i) Beginning [DATE 9 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], beginning 4
months after introduction of trichloroethylene into the workplace if
trichloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners or
operators must establish a regulated
[[Page 74790]]
area wherever any person's exposure to airborne concentrations of TCE
exceeds or can reasonably be expected to exceed the ECEL.
(ii) The owner or operator must limit access to regulated areas to
authorized persons.
(iii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the area and minimizes the number
of authorized persons exposed to TCE within the regulated area.
(iv) The owner or operator must supply a respirator that complies
with the requirements of paragraph (e) of this section and must ensure
that all persons within the regulated area are using the provided
respirators whenever TCE exposures may exceed the ECEL.
(v) An owner or operator who has implemented all feasible
engineering, work practice and administrative controls as required in
paragraph (c)(1)(i) of this section, and who has established a
regulated area as required by paragraph (b)(4)(i) of this section where
TCE exposure exceeds or can reasonably be expected to exceed the ECEL
only on certain days (for example, because of work or process schedule)
must have persons use respirators in that regulated area on those days.
(vi) The owner or operator must ensure that, within a regulated
area, persons do not engage in non-work activities which may increase
TCE exposure.
(vii) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities which interfere with respirator seal or performance.
(c) ECEL control procedures and plan--(1) Methods of compliance.
The owner or operator must institute one or a combination of
elimination, substitution, engineering controls or administrative
controls to reduce exposure to or below the ECEL except to the extent
that the owner or operator can demonstrate that such controls are not
feasible as an interim measure. Wherever the feasible exposure
controls, including one or a combination of elimination, substitution,
engineering controls or administrative controls, which can be
instituted are not sufficient to reduce exposure at or below the ECEL,
the owner or operator must use them to reduce exposure to the lowest
levels achievable by these controls and must supplement them by the use
of respiratory protection that complies with the requirements of
paragraph (e) of this section. Where an owner or operator cannot
demonstrate exposure below the ECEL or exposure at the lowest
achievable level for the facility, including through the use of
engineering controls or work practices, and has not demonstrated that
it has supplemented feasible exposure controls with respiratory
protection, this will constitute a failure to comply with the ECEL. The
owner or operator must maintain the effectiveness of engineering
controls or administrative controls instituted under paragraph
(d)(1)(i)(A) of this section. The owner or operator must not implement
a schedule of personnel rotation as a means of compliance with the
ECEL. The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (d)(2) of this section.
(2) Exposure control plan requirements. If any monitoring conducted
in accordance with paragraph (b)(3) of this section shows worker
exposures at or above the ECEL action level in the workplace, the owner
or operator, within [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], must include and document in an
exposure control plan the following:
(i) Identification and rationale of exposure controls used or not
used as a time-limited measure in the following sequence: elimination
of TCE, substitution of TCE, engineering controls and administrative
controls to reduce exposures in the workplace to either at or below the
ECEL or to the lowest achievable level of TCE in the workplace;
(ii) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(iii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(iv) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(v) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL or
lowest achievable exposure level;
(vi) Identification of the lowest achievable exposure level and why
further reductions are not possible;
(vii) Regular inspections, evaluations, and updating of the
exposure controls to ensure effectiveness and confirmation that all
persons are implementing them as required until the prohibition
compliance date;
(viii) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or lowest achievable exposure level and subsequent corrective
actions taken during start-up, shutdown, or malfunctions to mitigate
exposures to TCE; and
(ix) Availability of the exposure control plan and associated
records for potentially exposed persons.
(d) Workplace information and training. (1) The owner or operator
must provide information and training for each person prior to or at
the time of initial assignment to a job involving potential exposure to
TCE.
(2) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(3) The following information and training must be provided to all
persons assigned to a job involving potential exposure to TCE:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
TCE and the specific operations in the workplace that could result in
exposure to TCE, particularly noting where exposures may be above the
ECEL;
(iii) Methods and observations that may be used to detect the
presence or release of TCE in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of TCE when being released, etc.);
(iv) The health hazards of TCE in the workplace; and
(v) The principles of safe use and handling of TCE and measures
potentially exposed persons can take to protect themselves from TCE,
including specific procedures the owner or operator has implemented to
protect potentially exposed persons from exposure to TCE, such as
appropriate work practices, emergency procedures, and personal
protective equipment to be used.
(4) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of TCE in the
workplace.
(5) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures,
which increase
[[Page 74791]]
exposure, and where those exposures exceed or can reasonably be
expected to exceed the ECEL action level, the owner or operator must
update the training as necessary to ensure that each potentially
exposed person has the requisite proficiency.
(e) Personal protective equipment (PPE)--(1) Applicability. The
provisions of this paragraph (e) apply to any owner or operator that is
required to provide respiratory protection or dermal protection
pursuant to paragraphs (c)(1) and (d) of this section.
(2) Selection. PPE, including respiratory and dermal protection,
that is of safe design and construction for the work to be performed
must be provided, used, and maintained in a sanitary, reliable, and
undamaged condition. Owners and operators must select PPE that properly
fits each affected person and communicate PPE selections to each
affected person.
(3) Respiratory protection. (i) After 3 months of receipt of any
exposure monitoring or within [DATE 9 MONTHS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or operators must
supply a respirator, selected in accordance with this paragraph, to
each person who enters a regulated area and must ensure that all
persons within the regulated area are using the provided respirators
whenever TCE exposures may exceed the ECEL.
(ii) Owners or operators must provide respiratory protection in
accordance with the provisions outlined in 29 CFR 1910.134(a) through
(l) (except (d)(1)(iii)) and as specified in this paragraph for persons
exposed or who may be expose to TCE in concentrations above the ECEL.
For the purpose of this paragraph (e), the maximum use concentration
(MUC) as used in 29 CFR 1910.134 must be calculated by multiplying the
assigned protection factor (APF) specified for a respirator by the
ECEL. For the purposes of this paragraph (e), provisions in 29 CFR
1910.134(a) through (l) (except (d)(1)(iii)) applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(iii) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results, as follows:
(A) If the measured exposure concentration is at or below 0.0011
ppm (1.1 ppb): no respiratory protection is required.
(B) If the measured exposure concentration is above 0.0011 ppm (1.1
ppb) and less than or equal to 0.0055 ppm (5.5 ppb) (5 times ECEL): Any
National Institute for Occupational Safety and Health (NIOSH)-certified
air-purifying quarter mask respirator (APF 5).
(C) If the measured exposure concentration is above 0.0055 ppm (5.5
ppb) and less than or equal to 0.011 ppm (110 ppb) (10 times ECEL): Any
NIOSH-certified air-purifying half mask or full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters (APF
10).
(D) If the measured exposure concentration is above 0.011 ppm (11.0
ppb) and less than or equal to 0.0275 ppm (27.5 ppb) (25 times ECEL):
Any NIOSH-certified air-purifying full facepiece respirator equipped
with NIOSH-approved organic vapor cartridges or canisters; any NIOSH-
certified powered air-purifying respirator equipped with NIOSH-approved
organic vapor cartridges; or any NIOSH-certified continuous flow
supplied air respirator equipped with a hood or helmet (APF 25).
(E) If the measured exposure concentration is above 0.0275 ppm
(27.5 ppb) and less than or equal to 0.055 ppm (55.0 ppb) (50 times
ECEL): Any NIOSH-certified air-purifying full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters; or
any NIOSH-certified powered air-purifying respirator equipped with a
tight-fitting half facepiece and a NIOSH-approved organic vapor
cartridges or canisters; any NIOSH-certified negative pressure (demand
mode) supplied-air respirator equipped with a full facepiece; any
NIOSH-certified continuous flow supplied-air respirator equipped with a
tight-fitting half facepiece; any NIOSH-certified supplied air
respirator equipped with a half facepiece and operated in a pressure
demand or other positive pressure mode; or any NIOSH-certified negative
pressure (demand mode) self-contained breathing apparatus respirator
equipped with a full facepiece (APF 50).
(F) If the measured exposure concentration is above 0.055 ppm (55.0
ppb) and less than or equal to 1.1 ppm (1,100 ppb) (1,000 times ECEL):
Any NIOSH-certified powered air-purifying respirator equipped with a
full facepiece and NIOSH-approved organic vapor cartridges or
canisters; any NIOSH-certified supplied air respirator equipped with a
full facepiece and operated in a continuous flow mode or pressure
demand or other positive pressure mode (APF 1,000).
(G) If the measured exposure concentration is greater than 1.1 ppm
(1,100 ppb) (1,000 times ECEL) or the concentration is unknown: Any
NIOSH-certified self-contained breathing apparatus equipped with a full
facepiece and operated in a pressure demand or other positive pressure
mode; or any NIOSH-certified supplied air respirator equipped with a
full facepiece and operated in a pressure demand or other positive
pressure mode in combination with an auxiliary self-contained breathing
apparatus operated in a pressure demand or other positive pressure mode
(APF 10,000).
(iv) The respiratory protection requirements in this paragraph
represent the minimum respiratory protection requirements, such that
any respirator affording a higher degree of protection than the
required respirator may be used.
(v) When a person whose job requires the use of a respirator cannot
use a negative-pressure respirator, the owner or operator must provide
that person with a respirator that has less breathing resistance than
the negative-pressure respirator, such as a powered air-purifying
respirator or supplied-air respirator, when the person is able to use
it and if it provides the person with adequate protection.
(vi) Owners or operators must document the notice to and ability of
any potentially exposed person to access the exposure control plan and
other associated records.
(4) Dermal protection. The owner or operator must supply and
require the donning of gloves that are chemically resistant to TCE with
activity-specific training where dermal contact with TCE is possible,
after application of the requirements in paragraph (e) of this section,
in accordance with the hierarchy of controls.
(5) PPE training. (i) Owners and operators must provide PPE
training in accordance with 29 CFR 1910.132(f) to all persons required
to use PPE prior to or at the time of initial assignment to a job
involving potential exposure to TCE. For the purposes of this paragraph
(e)(5)(i), provisions in 29 CFR 1910.132(f) applying to an ``employee''
also apply equally to potentially exposed persons, and provisions
applying to an ``employer'' also apply equally to owners or operators.
(ii) Owners and operators must retrain each potentially exposed
person required to use PPE annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use PPE, or when
changes in the workplace or in PPE to be used render the previous
training obsolete.
[[Page 74792]]
Sec. 751.313 Downstream notification.
(a) Beginning on [DATE 2 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], each person who manufactures
(including imports) TCE for any use must, prior to or concurrent with
the shipment, notify companies to whom TCE is shipped, in writing, of
the restrictions described in this subpart in accordance with paragraph
(c) of this section.
(b) Beginning on [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], each person who processes or
distributes in commerce TCE or any TCE-containing products for any use
must, prior to or concurrent with the shipment, notify companies to
whom TCE is shipped, in writing, of the restrictions described in this
subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in section 1(c) and
15 of the Safety Data Sheet (SDS) provided with the TCE or with any
TCE-containing product:
After [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN
THE FEDERAL REGISTER], this chemical/product is and can only be
distributed in commerce or processed for the following purposes until
the following prohibitions take effect: (1) Processing as an
intermediate; a) for the manufacture of HFC-134a until [DATE 8.5 YEARS
AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] and b)
for all other processing as a reactant/intermediate until [DATE 2 YEARS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER];
(2) Industrial and commercial use as a solvent for open-top batch vapor
degreasing until [DATE 1 YEAR AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER]; (3) Industrial and commercial use as a
solvent for closed-loop batch vapor degreasing until [DATE 1 YEAR AFTER
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], except
for industrial and commercial use as a solvent for closed-loop batch
vapor degreasing necessary for human-rated rocket engine cleaning by
NASA and its contractors until [DATE 7 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], and except for industrial
and commercial use as a solvent for closed-loop batch vapor degreasing
for rayon fabric scouring for end use in rocket booster nozzle
production by Federal agencies and their contractors until [DATE 10
YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER]; (4) Industrial and commercial use as a processing aid in: a)
battery separator manufacturing until [DATE 10 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] and b) process
solvent used in polymer fiber spinning, fluoroelastomer manufacture and
Alcantara manufacture; extraction solvent used in caprolactam
manufacture; precipitant used in beta-cyclodextrin manufacture until
[DATE 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER]; (5) Industrial and commercial uses for DoD naval
vessels and their systems, and in the maintenance, fabrication, and
sustainment for and of such vessels and systems until [DATE 10 YEARS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER];
and (6) Industrial and commercial use for laboratory use for essential
laboratory activities until [DATE 50 YEARS AFTER DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER].
Sec. 751.315 Recordkeeping requirements.
(a) General records. After [DATE 60 DAYS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons who
manufacture, process, distribute in commerce, or engage in industrial
or commercial use of TCE or TCE-containing products must maintain
ordinary business records, such as invoices and bills-of-lading related
to compliance with the prohibitions, restrictions, and other provisions
of this subpart.
(b) Workplace chemical protection program compliance--(1) ECEL
exposure monitoring. For each monitoring event of TCE, owners or
operators subject to the ECEL described in Sec. 751.311(b) must
document the following:
(i) Dates, duration, and results of each sample taken;
(ii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iii) Identification of all persons represented by the
representative sampling monitoring, indicating which persons were
actually monitored;
(iv) Name, workplace address, work shift, job classification, and
work area of the person monitored; documentation of all potentially
exposed persons whose exposures the monitoring is intended to represent
if using a representative sample; and type of respiratory protective
device worn by the monitored person, if any;
(v) Use of appropriate sampling and analytical methods, such as
analytical methods already approved by EPA, Occupational Safety and
Health Administration (OSHA) or NIOSH, or compliance with an analytical
method verification procedure;
(vi) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792; and
(vii) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.311(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.311(d)(2);
(ii) Facility exposure monitoring records;
(iii) Notifications of exposure monitoring results;
(iv) The name, workplace address, work shift, job classification,
work area and respiratory protection used by each potentially exposed
person and PPE program implementation, as described in Sec.
751.311(e), including fit-testing and training; and
(v) Information and training provided by the regulated entity to
each person prior described in paragraph Sec. 751.311(d) and (e).
(c) Records related to Sec. 751.317 exemptions. To maintain
eligibility for an exemption described in Sec. 751.317, owners or
operators must maintain records demonstrating compliance with the
specific conditions of the exemption.
(d) Records related to Sec. Sec. 751.307 and 751.309 phaseouts.
(1) Each manufacturer of HFC-134a who uses TCE as an intermediate must
maintain records of the annual quantity of TCE purchased and processed
from the year 2023 until the termination of all processing of TCE as an
intermediate.
(2) Each person using TCE under Sec. 751.309 for industrial and
commercial use as a solvent for closed-loop batch vapor degreasing for
rayon fabric scouring for end use in rocket booster nozzle production
by Federal agencies and their contractors, must maintain records
demonstrating that the end use is in rocket booster nozzle production
for Federal agencies and their contractors.
(3) After [DATE 5 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER],
[[Page 74793]]
each person using TCE under Sec. 751.309 for industrial and commercial
use as a solvent for closed-loop batch vapor degreasing, specifically
for rayon fabric scouring, must maintain records that demonstrate that
a final pre-launch test of rocket booster nozzles without using TCE was
completed.
(e) Minimum record retention periods. (1) The records required
under paragraphs (a) through (c) of this section must be retained for
at least 5 years from the date that such records were generated.
(2) The records required under paragraph (d) of this section must
be retained for at least 5 years after the use of TCE has ceased.
Sec. 751.317 Exemptions.
(a) In general. (1) The time-limited exemptions established in
Sec. 751.305(b)(12) and (13) are established in accordance with 15
U.S.C. 2605(g).
(2) In order to be eligible for the exemptions, regulated parties
must comply with all conditions established for such exemptions in
accordance with 15 U.S.C. 2605(g)(4).
(b) Exemptions under 15 U.S.C. 2605(g)(1)(A). (1) Laboratory use
for essential laboratory activities until [DATE 50 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]. The following
are specific conditions of the exemption for laboratory use at Sec.
751.305(b)(13):
(i) The industrial and commercial use of TCE as a laboratory
chemical must only be for the following:
(A) Essential laboratory activities, including chemical analysis,
chemical synthesis, extracting or purifying other chemicals, dissolving
other substances, and research and development for the advancement of
cleanup activities and analytical methods for monitoring related to TCE
contamination or exposure monitoring.
(B) Federal agencies and their contractors conducting research and
development activities and test and evaluation method activities, other
than those described in paragraph (b)(1)(i)(A) of this section, and
similar laboratory activities, provided the use is essential to the
agency's mission.
(ii) TCE must not be used as a laboratory chemical for testing
asphalt.
(iii) The use of TCE as a laboratory chemical must be performed on
the premises of industrial or commercial laboratories.
(iv) The owner or operator of the location where such use of TCE
occurs, and manufacturers (including importers) and processors of TCE
for such use, must comply with the Workplace Chemical Protection
Program provisions in Sec. 751.311.
(v) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec.
751.315.
(2) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purposes of
cleanup projects of TCE-contaminated water and groundwater until [DATE
50 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER]. The following are specific conditions of the exemption for
disposal at Sec. 751.305(b)(15):
(i) The disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works must only be for the
purposes of cleanup projects of TCE-contaminated water and groundwater.
The disposal of TCE to industrial pre-treatment, industrial treatment,
or publicly owned treatment works is limited to only sites undergoing
remediation under CERCLA, RCRA, or other Federal, state, and local
government laws, regulations, or requirements.
(ii) The owner or operator of the location where workers are
handling TCE wastewater, and owners or operators of facilities where
TCE is disposed to industrial pre-treatment, industrial treatment, or
publicly owned treatment works, must comply with the Workplace Chemical
Protection Program provisions in Sec. 751.311.
(iii) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec.
751.315.
(3) Use of TCE or TCE-containing products for the specific
conditions of use identified in paragraph (b)(3)(i) of this section in
an emergency by the National Aeronautics and Space Administration
(NASA) and its contractors operating within the scope of their
contracted work until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER].
(i) Applicability. The emergency use exemption described in this
paragraph (b)(3) applies to the following specific conditions of use as
described in paragraph (b)(3)(i)(A) of this section.
(A) Conditions of use subject to this exemption--(1) Industrial and
commercial use as solvent for open-top or closed-loop batch vapor
degreasing.
(2) Industrial and commercial use as solvent for cold cleaning.
(3) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner and mold release.
(4) Industrial and commercial use as a lubricant and grease in tap
and die fluid.
(5) Industrial and commercial use as a lubricant and grease in
penetrating lubricant.
(6) Industrial and commercial use as an adhesive and sealant in
solvent-based adhesives and sealants.
(7) Industrial and commercial as a functional fluid in heat
exchange fluid.
(8) Industrial and commercial use in corrosion inhibitors and anti-
scaling agents.
(9) Industrial and commercial use of TCE as a processing aid.
(B) Emergency use--(1) In general. An emergency is a serious and
sudden situation requiring immediate action, within 15 days or less,
necessary to protect:
(i) Safety of NASA's or their contractors' personnel;
(ii) NASA's missions;
(iii) Human health, safety, or property, including that of adjacent
communities; or
(iv) The environment.
(2) Duration. Each emergency is a separate situation; if use of TCE
exceeds 15 days, then justification must be documented.
(3) Eligibility. To be eligible for the exemption, the NASA and its
contractors must:
(i) Select TCE because there are no technically and economically
feasible safer alternatives available during the emergency.
(ii) Perform the emergency use of TCE at locations controlled by
NASA or its contractors.
(ii) Requirements. To be eligible for the emergency use exemption
described in this paragraph (b)(3), the NASA and its contractors must
comply with the following conditions:
(A) Notification. Within 15 working days of the emergency use by
NASA and its contractors, NASA must provide notice to EPA that includes
the following:
(1) Identification of the conditions of use detailed in paragraph
(b)(3)(i)(A) of this section that the emergency use fell under;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(3)(i)(B) of this section; and
(3) An explanation of why TCE was selected, including why there
were no technically and economically feasible safer alternatives
available in the particular emergency.
(B) Exposure control. The owner or operator must comply with the
Workplace Chemical Protection Program provisions in Sec. 751.311, to
the extent
[[Page 74794]]
technically feasible in light of the particular emergency.
(C) Recordkeeping. The owner or operator of the location where the
use takes place must comply with the recordkeeping requirements in
Sec. 751.315.
(c) Exemptions under 15 U.S.C. 2605(g)(1)(B)--(1) Lead-acid and
lithium battery separator manufacturing until [DATE 10 YEARS AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]. The
following are specific conditions of the exemption for use as a
processing aid in the manufacturing of lead-acid and lithium battery
separators at Sec. 751.305(b)(12):
(i) The use of TCE as a processing aid for battery separator
manufacturing must be limited to lead acid or lithium battery separator
manufacturing.
(ii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.311.
(iii) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec.
751.315.
(2) Certain industrial and commercial uses of TCE for DoD naval
vessels and their systems, and in the maintenance, fabrication, and
sustainment for and of such vessels and systems until [DATE 10 YEARS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].
The following are specific conditions of the exemption for industrial
and commercial uses of TCE for DoD naval vessel and their systems, and
in the maintenance, fabrication, and sustainment for and of such
vessels and systems:
(i) The industrial and commercial use of TCE must be limited for
DoD naval vessels and their systems, and in the maintenance,
fabrication, and sustainment for and of such vessels and systems; as
potting compounds for naval electronic systems and equipment; sealing
compounds for high and ultra high vacuum systems; bonding compounds for
materials testing and maintenance of underwater systems and bonding of
nonmetallic materials; and cleaning requirements (which includes
degreasing using wipes, sprays, solvents and vapor degreasing) for:
materials and components required for military ordnance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes.
(ii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.311.
(iii) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec.
751.315.
(3) Closed-loop vapor degreasing necessary for human-rated rocket
engine cleaning by NASA and its contractors until [DATE 7 YEARS AFTER
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]. The
following are specific conditions of the exemption for industrial and
commercial use of TCE as a solvent for closed-loop vapor degreasing
necessary for human-rated rocket engine cleaning by NASA and its
contractors Sec. 751.305(b)(12):
(i) The use of TCE in industrial and commercial as a solvent for
closed-loop vapor degreasing is limited to the closed-loop vapor
degreasing necessary for human-rated rocket engine cleaning by NASA and
its contractors.
(ii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.311.
(iii) The owner or operator of the location where such use of TCE
occurs, and manufacturers (including importers) and processors of TCE
for such use, must comply with the recordkeeping requirements in Sec.
751.315.
[FR Doc. 2023-23010 Filed 10-30-23; 8:45 am]
BILLING CODE 6560-50-P