Proposed Rule2023-12495
Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is proposing to address the unreasonable risk of injury to human health presented by perchloroethylene (PCE) under its conditions of use as documented in EPA's December 2020 Risk Evaluation for PCE and December 2022 revised risk determination for PCE prepared under the Toxic Substances Control Act (TSCA). PCE is a widely used solvent in a variety of occupational and consumer applications including fluorinated compound production, petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. PCE, also known as perc and tetrachloroethylene, is a neurotoxicant and a likely human carcinogen. Neurotoxicity, in particular impaired visual and cognitive function and diminished color discrimination, are the most sensitive adverse effects driving the unreasonable risk of PCE, and other adverse effects associated with exposure include central nervous system depression, kidney and liver effects, immune system toxicity, developmental toxicity, and cancer. To address the identified unreasonable risk, EPA is proposing to prohibit most industrial and commercial uses of PCE; the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; and, the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 10- year phaseout. For certain conditions of use that would not be subject to a prohibition, EPA is also proposing to require a PCE workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. EPA is also proposing to require prescriptive workplace controls for laboratory use, and to establish recordkeeping and downstream notification requirements. Additionally, EPA proposes to provide certain time-limited exemptions from requirements for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available.
Full Text
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<title>Federal Register, Volume 88 Issue 116 (Friday, June 16, 2023)</title>
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[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Proposed Rules]
[Pages 39652-39723]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12495]
[[Page 39651]]
Vol. 88
Friday,
No. 116
June 16, 2023
Part IV
Environmental Protection Agency
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40 CFR Part 751
Perchloroethylene (PCE); Regulation under the Toxic Substances Control
Act (TSCA); Proposed Rule
Federal Register / Vol. 88 , No. 116 / Friday, June 16, 2023 /
Proposed Rules
[[Page 39652]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0720; FRL-8329-02-OCSPP]
RIN 2070-AK84
Perchloroethylene (PCE); 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
perchloroethylene (PCE) under its conditions of use as documented in
EPA's December 2020 Risk Evaluation for PCE and December 2022 revised
risk determination for PCE prepared under the Toxic Substances Control
Act (TSCA). PCE is a widely used solvent in a variety of occupational
and consumer applications including fluorinated compound production,
petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA
determined that PCE presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to PCE, including neurotoxicity effects from acute and chronic
inhalation exposures and dermal exposures, and cancer from chronic
inhalation exposures to PCE. TSCA requires that EPA address by rule any
unreasonable risk of injury to health or the environment identified in
a TSCA risk evaluation and apply requirements to the extent necessary
so the chemical no longer presents unreasonable risk. PCE, also known
as perc and tetrachloroethylene, is a neurotoxicant and a likely human
carcinogen. Neurotoxicity, in particular impaired visual and cognitive
function and diminished color discrimination, are the most sensitive
adverse effects driving the unreasonable risk of PCE, and other adverse
effects associated with exposure include central nervous system
depression, kidney and liver effects, immune system toxicity,
developmental toxicity, and cancer. To address the identified
unreasonable risk, EPA is proposing to prohibit most industrial and
commercial uses of PCE; the manufacture (including import), processing,
and distribution in commerce of PCE for the prohibited industrial and
commercial uses; the manufacture (including import), processing, and
distribution in commerce of PCE for all consumer use; and, the
manufacture (including import), processing, distribution in commerce,
and use of PCE in dry cleaning and related spot cleaning through a 10-
year phaseout. For certain conditions of use that would not be subject
to a prohibition, EPA is also proposing to require a PCE workplace
chemical protection program that includes requirements to meet an
inhalation exposure concentration limit and prevent direct dermal
contact. EPA is also proposing to require prescriptive workplace
controls for laboratory use, and to establish recordkeeping and
downstream notification requirements. Additionally, EPA proposes to
provide certain time-limited exemptions from requirements for certain
critical or essential emergency uses of PCE for which no technically
and economically feasible safer alternative is available.
DATES: Comments must be received on or before August 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 July 17, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0720, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets/">https://www.epa.gov/dockets/</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kelly Summers, 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) 564-2201; email
address: <a href="/cdn-cgi/l/email-protection#c2928187ec9691818382a7b2a3eca5adb4"><span class="__cf_email__" data-cfemail="1d4d5e5833494e5e5c5d786d7c337a726b">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#80d4d3c3c1adc8eff4ece9eee5c0e5f0e1aee7eff6"><span class="__cf_email__" data-cfemail="dd898e9e9cf095b2a9b1b4b3b89db8adbcf3bab2ab">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of PCE or products containing PCE. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities include:
<bullet> Crude Petroleum Extraction (NAICS code 211120).
<bullet> Support Activities for Oil and Gas Operations (NAICS code
213112).
<bullet> Nonwoven Fabric Mills (NAICS code 313230).
<bullet> Wood Window and Door Manufacturing (NAICS code 321911).
<bullet> Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220).
<bullet> Commercial Screen Printing (NAICS code 323113).
<bullet> Petroleum Refineries (NAICS code 324110).
<bullet> Petroleum Lubricating Oil and Grease Manufacturing (NAICS
code 324191).
<bullet> Petrochemical Manufacturing (NAICS code 325110).
<bullet> Industrial Gas Manufacturing (NAICS code 325120).
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180).
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199).
<bullet> Plastics Material and Resin Manufacturing (NAICS code
325211).
<bullet> Synthetic Rubber Manufacturing (NAICS code 325212).
<bullet> Paint and Coating Manufacturing (NAICS code 325510).
<bullet> Adhesive Manufacturing (NAICS code 325520).
<bullet> Soap and Other Detergent Manufacturing (NAICS code
325611).
<bullet> Polish and Other Sanitation Good Manufacturing (NAICS code
325612).
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998).
<bullet> Unlaminated Plastics Film and Sheet (except Packaging)
Manufacturing (NAICS code 326113).
<bullet> All Other Plastics Product Manufacturing (NAICS code
326199).
<bullet> Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220).
<bullet> Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291).
<bullet> All Other Rubber Product Manufacturing (NAICS code
326299).
[[Page 39653]]
<bullet> Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110).
<bullet> Glass Container Manufacturing (NAICS code 327213).
<bullet> Cement Manufacturing (NAICS code 327310).
<bullet> Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492).
<bullet> Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119).
<bullet> Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215).
<bullet> Saw Blade and Handtool Manufacturing (NAICS code 332216).
<bullet> Other Fabricated Wire Product Manufacturing (NAICS code
332618).
<bullet> Metal Heat Treating (NAICS code 332811).
<bullet> Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812).
<bullet> Electroplating, Plating, Polishing, Anodizing, and
Coloring (NAICS code 332813).
<bullet> Industrial Valve Manufacturing (NAICS code 332911).
<bullet> Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912).
<bullet> Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913).
<bullet> Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919).
<bullet> Ball and Roller Bearing Manufacturing (NAICS code 332991).
<bullet> Small Arms Ammunition Manufacturing (NAICS code 332992).
<bullet> Ammunition (except Small Arms) Manufacturing (NAICS code
332993).
<bullet> Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994).
<bullet> Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996).
<bullet> All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999).
<bullet> Other Industrial Machinery Manufacturing (NAICS code
333249).
<bullet> Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415).
<bullet> Machine Tool Manufacturing (NAICS code 333517).
<bullet> Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914).
<bullet> Welding and Soldering Equipment Manufacturing (NAICS code
333992).
<bullet> Packaging Machinery Manufacturing (NAICS code 333993).
<bullet> Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994).
<bullet> Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995).
<bullet> Fluid Power Pump and Motor Manufacturing (NAICS code
333996).
<bullet> All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999).
<bullet> Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513).
<bullet> Analytical Laboratory Instrument Manufacturing (NAICS code
334516).
<bullet> Motor Vehicle Body Manufacturing (NAICS code 336211).
<bullet> Travel Trailer and Camper Manufacturing (NAICS code
336214).
<bullet> Other Motor Vehicle Parts Manufacturing (NAICS code
336390).
<bullet> Aircraft Manufacturing (NAICS code 336411).
<bullet> Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412).
<bullet> Other Aircraft Parts and Auxiliary Equipment Manufacturing
(NAICS code 336413).
<bullet> Guided Missile and Space Vehicle Manufacturing (NAICS code
336414).
<bullet> Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415).
<bullet> Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419).
<bullet> Ship Building and Repairing (NAICS code 336611).
<bullet> Surgical and Medical Instrument Manufacturing (NAICS code
339112).
<bullet> Jewelry and Silverware Manufacturing (NAICS code 339910).
<bullet> Sporting and Athletic Goods Manufacturing (NAICS code
339920).
<bullet> Doll, Toy, and Game Manufacturing (NAICS code 339930).
<bullet> Office Supplies (except Paper) Manufacturing (NAICS code
339940).
<bullet> Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991).
<bullet> Musical Instrument Manufacturing (NAICS code 339992).
<bullet> Fastener, Button, Needle, and Pin Manufacturing (NAICS
code 339993).
<bullet> Broom, Brush, and Mop Manufacturing (NAICS code 339994).
<bullet> Burial Casket Manufacturing (NAICS code 339995).
<bullet> All Other Miscellaneous Manufacturing (NAICS code 339999).
<bullet> Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS code 423120).
<bullet> Home Furnishing Merchant Wholesalers (NAICS code 423220).
<bullet> Industrial Supplies Merchant Wholesalers (NAICS code
423840).
<bullet> Service Establishment Equipment and Supplies Merchant
Wholesalers (NAICS code 423850).
<bullet> Other Miscellaneous Durable Goods Merchant Wholesalers
(NAICS code 423990).
<bullet> Grain and Field Bean Merchant Wholesalers (NAICS code
424510).
<bullet> Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690).
<bullet> Petroleum Bulk Stations and Terminals (NAICS code 424710).
<bullet> Petroleum and Petroleum Products Merchant Wholesalers
(except Bulk Stations and Terminals) (NAICS code 424720).
<bullet> New Car Dealers (NAICS code 441110).
<bullet> Used Car Dealers (NAICS code 441120).
<bullet> Other Gasoline Stations (NAICS code 447190).
<bullet> Sporting Goods Stores (NAICS code 451110).
<bullet> All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS code 453998).
<bullet> Scheduled Passenger Air Transportation (NAICS code
481111).
<bullet> Scheduled Freight Air Transportation (NAICS code 481112).
<bullet> Pipeline Transportation of Natural Gas (NAICS code
486210).
<bullet> Teleproduction and Other Postproduction Services (NAICS
code 512191).
<bullet> Other Motion Picture and Video Industries (NAICS code
512199).
<bullet> Miscellaneous Intermediation (NAICS code 523910).
<bullet> Other Financial Vehicles (NAICS code 525990).
<bullet> Lessors of Other Real Estate Property (NAICS code 531190).
<bullet> Offices of Real Estate Agents and Brokers (NAICS code
531210).
<bullet> Testing Laboratories (NAICS code 541380).
<bullet> Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715).
<bullet> Marketing Research and Public Opinion Polling (NAICS code
541910).
<bullet> All Other Professional, Scientific, and Technical Services
(NAICS code 541990).
<bullet> Offices of Other Holding Companies (NAICS code 551112).
<bullet> Hazardous Waste Treatment and Disposal (NAICS code
562211).
<bullet> Solid Waste Landfill (NAICS code 562212).
<bullet> Solid Waste Combustors and Incinerators (NAICS code
562213).
<bullet> Other Nonhazardous Waste Treatment and Disposal (NAICS
code 562219).
<bullet> Remediation Services (NAICS code 562910).
<bullet> Materials Recovery Facilities (NAICS code 562920).
[[Page 39654]]
<bullet> All Other Miscellaneous Waste Management Services (NAICS
code 562998).
<bullet> General Automotive Repair (NAICS code 811111).
<bullet> Automotive Exhaust System Repair (NAICS code 811112).
<bullet> Automotive Transmission Repair (NAICS code 811113).
<bullet> Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118).
<bullet> Automotive Body, Paint, and Interior Repair and
Maintenance (NAICS code 811121).
<bullet> Automotive Glass Replacement Shops (NAICS code 811122).
<bullet> Automotive Oil Change and Lubrication Shops (NAICS code
811191).
<bullet> All Other Automotive Repair and Maintenance (NAICS code
811198).
<bullet> Consumer Electronics Repair and Maintenance (NAICS code
811211).
<bullet> Computer and Office Machine Repair and Maintenance (NAICS
code 811212).
<bullet> Communication Equipment Repair and Maintenance (NAICS code
811213).
<bullet> Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219).
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310).
<bullet> Home and Garden Equipment Repair and Maintenance (NAICS
code 811411).
<bullet> Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490).
<bullet> Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320).
<bullet> Industrial Launderers (NAICS code 812332).
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127; see also 19 CFR 127.28. Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S.
Environmental Protection Agency hereinafter EPA or ``the Agency,''
determines through a TSCA section 6(b) risk evaluation that a chemical
substance presents an unreasonable risk of injury to health or the
environment, EPA must by rule apply one or more requirements listed in
TSCA section 6(a) to the extent necessary so that the chemical
substance or mixture no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that PCE 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 PCE by EPA, under the conditions of use
(Refs. 1 and 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 drive EPA's
determination that PCE presents an unreasonable risk is included in
Unit III.B.1. EPA notes that all TSCA conditions of use of PCE are
subject to this proposal. Accordingly, to address the unreasonable
risk, EPA is proposing, under TSCA section 6(a), to:
(i) Prohibit most industrial and commercial uses and the
manufacture (including import), processing, and distribution in
commerce, of PCE for those uses, outlined in Unit IV.A.1.;
(ii) Prohibit the manufacture (including import), processing, and
distribution in commerce of PCE for all consumer use, outlined in Unit
IV.A.1.;
(iii) Prohibit the manufacture (including import), processing,
distribution in commerce, and commercial use of PCE in dry cleaning and
spot cleaning through a 10-year phaseout, outlined in Unit IV.A.1.;
(iv) Require strict workplace controls, including a PCE Workplace
Chemical Protection Program (WCPP), which would include requirements to
meet an inhalation exposure concentration limit and prevent direct
dermal contact with PCE, for the 16 occupational conditions of use not
prohibited, outlined in Unit IV.A.2.;
(v) Require prescriptive workplace controls for laboratory use,
outlined in Unit IV.A.3.; and
(vi) Establish recordkeeping and downstream notification
requirements, outlined in Unit IV.A.4.
(vii) Provide a 10-year time limited exemption under TSCA section
6(g) for certain emergency uses of PCE in furtherance of National
Aeronautics and Space Administration's mission, for specific conditions
of use which are critical or essential and for which no technically and
economically feasible safer alternative is available, outlined in Unit
IV.A.5.
In addition, EPA is proposing to amend the general provision of 40
CFR part 751, subpart A, to define ``authorized person,'' ``direct
dermal contact,'' ``ECEL,'' ``exposure group,'' ``owner or operator,''
``potentially exposed person,'' ``regulated area,'' and ``retailer'' 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. 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.'' PCE was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in December 2020 (2020 Risk Evaluation for
PCE) (Ref. 1). In addition, EPA issued a revised unreasonable risk
determination in December 2022 (Ref. 2), determining that PCE, 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 PCE no longer presents such
risk. The unreasonable risk is described in Unit III.B.2. and the
conditions of use that drive the unreasonable risk for PCE are
described in Unit III.B.1.
[[Page 39655]]
PCE's hazards are well established. EPA's 2020 Risk Evaluation for
PCE considered the hazards associated with exposure to PCE and
determined that PCE presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to PCE. While some of the risks of adverse effects from PCE exposure
are associated with acute single exposures, other risks are associated
with long-term repeated exposures. The most sensitive health effect
driving the unreasonable risk of PCE and selected as the basis for this
proposed rule is neurotoxicity, based on the best available science and
weight of scientific evidence and in consideration of the severity of
the hazards, magnitude of exposure, population exposed, and
uncertainties in the December 2020 Risk Evaluation for PCE and December
2022 revised risk determination for PCE. The most sensitive endpoint is
dependent on both the point of departure (POD) and the associated total
uncertainty factor. For PCE, impaired visual and cognitive function and
diminished color discrimination following chronic exposures represent
the most sensitive endpoint indicating neurotoxicity, based on
epidemiological data reported in two studies that identified lowest
observed adverse effect levels for color confusion and impaired pattern
recognition and reaction time in pattern memory. Other significant
adverse outcomes include kidney and liver effects, immune system
toxicity, reproductive toxicity, developmental toxicity, and cancer.
For this proposed rulemaking, EPA has determined that protecting
against the most sensitive endpoint would also address the risk for
other acute, chronic non-cancer, and cancer endpoints. This proposed
rule would eliminate the unreasonable risk to human health from the
TSCA conditions of use of PCE, as identified in the 2020 Risk
Evaluation for PCE and the revised unreasonable risk determination for
PCE in December 2022.
EPA is not proposing a complete ban on PCE. The Agency has
considered the benefits of PCE for various uses as required under TSCA
section 6(c)(2)(A) and (B) and recognizes that continued use of PCE for
some TSCA conditions of use may provide benefits that complement the
Agency's efforts to address climate-damaging hydrofluorocarbons (HFCs)
under the American Innovation and Manufacturing Act of 2020 (AIM Act)
(42 U.S.C. 7675), supporting human health and environmental protection
under these programs, and that for these uses, strict workplace
controls to address the unreasonable risk can be implemented.
Therefore, this rule proposes to allow PCE's continued use in tandem
with strict workplace controls for the generation of HFC-125 and HFC-
134a, two of the regulated substances that are subject to a phasedown
under the AIM Act. While HFC-125 and HFC-134a are two of the regulated
substances subject to the phasedown in production and consumption by
85% over the next 15 years, HFCs-134a and -125 can be mixed with other
substances to make lower global warming potential 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
be important for national security applications or for other critical
needs. For example, PCE is a critical diluent (to modify the
consistency or other properties in a formulation) for maskant applied
to military and commercial aircraft skin panels that prevents chemical
milling or industrial etching of certain areas and is also used in
petrochemical manufacturing as a processing aid in catalyst
regeneration for reformate and isomerate (these are gasoline blending
stocks) that make up an estimated 45% of the U.S. gasoline pool.
Therefore, this rule proposes to allow certain continued uses of PCE
provided that sufficient worker protections are in place to address the
unreasonable risk for certain occupational conditions of use. For the
conditions of use for which EPA is proposing strict workplace controls
under a WCPP, EPA expects that many workplaces already have stringent
controls in place that reduce exposures to PCE; for some workplaces,
EPA understands that these existing controls may already reduce
exposures enough to meet the inhalation exposure concentration limit
proposed in this rulemaking or to prevent direct dermal contact with
PCE.
Accordingly, EPA is proposing strict workplace controls to address
the unreasonable risk and allow continued use of PCE for several
conditions of use, including for processing as a reactant/intermediate,
use in vapor degreasing, use as a maskant for chemical milling, use in
adhesives and sealants, use as a processing aid in catalyst
regeneration in petrochemical manufacturing, and use as a laboratory
chemical, which comprise more than an estimated 80% of the current
production volume of PCE. EPA is proposing to ban or phaseout most
conditions of use of PCE, including use in dry cleaning and spot
cleaning, aerosol degreasing, paints and coatings, aerosol lubricants,
and wipe cleaning, comprising less than an estimated 20% of the current
production volume of PCE. Of the conditions of use that would not be
prohibited, EPA expects the production volume for those conditions of
use to decline over time. For example, EPA expects the industrial and
commercial use of PCE as a reactant in the generation of HFC-134a and
HFC-125 to decline over time, in light of the AIM Act requirements to
phase down production and consumption of listed HFCs by 85% over the
next 15 years. Unit IV.A. describes EPA's proposed regulatory action
and Unit IV.B. describes the alternative regulatory actions as required
under TSCA section 6(c)(2)(A). The rationale for the proposed
regulatory action and alternative regulatory actions, including the
TSCA section 6 requirements considered in developing the regulatory
actions, is described in Units III.B.3. and V.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis of the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 3). As described in more detail in the Economic
Analysis (Ref. 3) and in Units VI.D. and X.D., EPA was unable to
quantify all incremental costs of this proposed rule. The quantifiable
cost of the proposed rule is estimated to be $14.0 million annualized
over 20 years at a 3% discount rate and $14.3 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 0.14 ppm (0.98 mg/m\3\) for
inhalation exposures as an 8-hour time-weighted average (TWA), dermal
controls to prevent direct dermal contact, applicable personal
protective equipment (PPE) requirements, and reformulation costs of
numerous products. The most notable unquantified costs include possible
costs from prohibition of use of PCE as a processing aid outside of the
petrochemical industry; EPA's analysis was unable to quantify these
costs, as described more fully in section 7.11 in the Economic Analysis
(Ref. 3). The economic impact on users of PCE for chemical milling and
vapor degreasing is also unclear because there are no clear
alternatives to PCE; these users might have to use PPE to meet the
requirements of a WCPP for PCE.
[[Page 39656]]
Chemical milling using PCE is most prominent in the aerospace industry.
Vapor degreasing is used in several advanced manufacturing industries,
including aerospace, automotive, energy, medical devices, and others
(Ref. 3).
In addition, EPA estimates that 6,000 dry cleaners still use PCE, a
majority of which are small businesses. Nevertheless, despite
information EPA has sought from stakeholders, it is still unclear as to
the impact of a prohibition of PCE for dry cleaning through a gradual
phaseout; EPA has not been able to estimate the number of dry cleaning
facility closures that may be associated with this phaseout. More
information on the challenges of estimating these impacts, in part due
to the age of relevant machines in use, is in the Economic Analysis
(Ref. 3). Overall, EPA expects few closures because EPA estimates that
only about 60 PCE machines are expected to be in use at the end of the
proposed phaseout period given the age of the machines and the
declining trend of use; this is detailed in section 7.7 of the Economic
Analysis. Table 7-10 in that section details the age of the PCE dry
cleaning machines in New York State, for which EPA has data. EPA
believes that the data is generalizable to other states; industry has
informed the Agency that very few PCE machines have been purchased in
recent years. Based on the estimated revenues per firm presented in
Table 31 of the Economic Analysis and the 6,000 estimated number of dry
cleaning firms using PCE as dry cleaning solvent (see section 6.1.5 (A)
of the Economic Analysis), the total revenue for dry cleaning firms
using PCE as dry cleaning solvent is approximately $3.1 billion.
According to IRS (2013) data, profit in this sector is about 4.8% of
sales, implying that total profit of firms using PCE as dry cleaning
solvent is about $148 million. However, EPA has proposed a 10-year
phaseout of PCE in dry cleaning and estimates that only about 60 PCE
dry cleaning machines would remain at the end of the phaseout (see
section 7.7.3. of the Economic Analysis). This suggests that the
proposed option would only affect about $31 million of the industry's
total revenue and about $1.5 million of the industry's profit. Many of
these firms would likely choose to purchase non-PCE machines or become
drop shops (do dry cleaning at another site) rather than close. A
detailed sensitivity analysis of varying assumptions on ages of PCE dry
cleaning machines and PCE dry cleaning machine life is provided in
section 11 of the Economic Analysis.
The actions proposed in this rule are expected to achieve health
benefits for the American public, some of which can be monetized and
others that, while tangible and significant, cannot be monetized. The
monetized benefits of this proposed rule are approximately $10.2
million to $46.3 million annualized over 20 years at a 3% discount rate
and $4.72 million to $29.4 million annualized over 20 years at a 7%
discount rate. The monetized benefits include potential reductions in
risk of liver, kidney, brain, and testicular cancer. Non-monetized
benefits include risk reduction of neurotoxicity, kidney toxicity,
liver effects, immune/hematological effects, reproductive effects, and
developmental effects (Ref. 3). Neurotoxic effects of PCE in human
studies include visual deficits, impaired cognition, and decreased math
scores. Also, prenatal and early childhood exposure to PCE in drinking
water are associated with increases in drug, alcohol, and tobacco use
(Ref. 1). Reductions in PCE exposure are therefore likely to be
associated with large dollar-valued, but currently unmonetized,
benefits.
Additionally, the Agency expects that the proposed dry cleaning
phaseout will decrease health risks for affected populations that may
own/operate or work at dry cleaning facilities. As described in more
detail in the Economic Analysis, the Agency analyzed the demographic
characteristics of several populations that would be impacted by this
rulemaking, including for dry cleaning (Ref. 3). Based on reasonably
available information, the Agency understands that a significant number
of members of minority populations may own or work at dry cleaning
facilities.
II. Background
A. Overview of Perchloroethylene
This proposed rule applies to PCE (CASRN 127-18-4) and is
specifically intended to address the unreasonable risk of injury to
health EPA has identified in the 2020 Risk Evaluation for PCE and the
2022 revised unreasonable risk determination, as described in Unit
III.B.2. PCE is a colorless volatile liquid with a mildly sweet odor
that is produced in and imported into the United States. PCE is
manufactured, processed, distributed, used, and disposed of as part of
many industrial, commercial, and consumer conditions of use.
As outlined in further detail in Unit III.B.1., PCE is used for the
production of fluorinated compounds, as a solvent for dry cleaning and
vapor degreasing; in catalyst regeneration in petrochemical
manufacturing; and in a variety of commercial and consumer applications
such as adhesives, paints and coatings, aerosol degreasers, brake
cleaners, aerosol lubricants, sealants, stone polish, stainless steel
polish and wipe cleaners. According to data submitted for the EPA's
2016 Chemical Data Reporting rule (CDR), the total aggregate annual
production volume of PCE in the U.S. decreased from 388 million pounds
to around 324 million pounds between 2012 and 2015 (Ref. 4). The total
aggregate annual production volume ranged from 250 to 500 million
pounds between 2016 and 2019 according to CDR (Ref. 5).
B. Regulatory Actions Pertaining to PCE
Because of its adverse health effects, PCE 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 PCE, as well other Federal, state, and
international regulations (Ref. 6) is in the docket and in Appendix A
of the 2020 Risk Evaluation for PCE (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 nonrisk 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.'' 15 U.S.C. 2605(a). 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
[[Page 39657]]
susceptibility or greater exposure, may be at greater risk than the
general population of adverse health effects from exposure to a
chemical substance or mixture, such as infants, children, pregnant
women, workers, or the elderly.''
The OSH Act similarly requires OSHA to evaluate risk specific to
workers prior to promulgating new or revised standards and requires
OSHA standards to substantially reduce significant risk to the extent
feasible, even if workers are exposed over a full working lifetime. See
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
Thus, the standards for chemical hazards that OSHA promulgates
under the OSH Act share a broadly similar purpose with the standards
that EPA promulgates under TSCA section 6(a). The control measures OSHA
and EPA require to satisfy the objectives of their respective statutes
may also, in many circumstances, overlap or coincide. However, as this
section 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. 6) 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, that
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. 7). 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 PCE. 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 notice, 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 frozen 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
[[Page 39658]]
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 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 many of OSHA's chemical-
specific standards are based on outdated information regarding the
technological and economic feasibility of the standards and the risks
associated with exposure, 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. The following unit 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.). (It
should be noted that there are some cases where scenarios may reflect
certain mitigation measures, such as 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
it does not question the veracity of public comments received on the
2020 Risk Evaluation for PCE 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 in order to inform its
risk management efforts (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 consistency with applicable OSHA
requirements and industry best practices, including appropriate
application of the hierarchy of controls (Ref. 8), 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.
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Consistent with TSCA section 9(d), EPA consults and coordinates TSCA
activities with OSHA and other relevant Federal agencies for the
purpose of achieving the maximum applicability of TSCA while avoiding
the imposition of duplicative requirements.
Informed by the mitigation scenarios and information gathered
during the risk evaluation and risk management process, the Agency
might propose rules that require risk management practices that may be
already common practice in many or most facilities. Adopting clear,
broadly applicable regulatory standards will foster compliance across
all facilities (ensuring a level playing field) and assure protections
for all affected workers, especially in cases where current OSHA
standards may not apply to them or not be sufficient to address the
unreasonable risk.
For evaluation scenarios which involve OSHA chemical-specific PELs,
EPA's risk evaluation in some cases may illustrate that limiting
exposure to OSHA's PEL would result in acceptable levels of risk under
TSCA under certain conditions of use. In these cases, TSCA risk
management requirements could incorporate and reinforce requirements in
OSHA standards and ensure that risks are addressed, including for
circumstances where OSHA requirements are not applicable (e.g., public
sector workers not covered by an OSHA State plan, and self-employed
workers) by asserting TSCA compliance/enforcement as well. EPA's risk
evaluation may also find unreasonable risk under TSCA associated with
some occupational conditions of use, 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. PCE and OSHA Requirements
EPA incorporated the considerations described earlier in this unit
in the 2020 Risk Evaluation for PCE, the December 2022 revised
unreasonable risk determination for PCE, and this rulemaking.
Specifically, in the TSCA 2020 Risk Evaluation for PCE, 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 presented an
unreasonable risk. Additional consideration of OSHA standards in the
revised unreasonable risk determination is discussed further in the
Federal Register notice announcing that document (Ref. 9). In Units
III.B.3. and Unit V., EPA outlines the importance of considering the
hierarchy of controls utilized 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
PCE. The hierarchy of controls is a prioritization of exposure control
strategies from most protective and preferred to least protective and
preferred techniques. In order of precedence, they are: 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. 8). Under the
hierarchy of controls the use of respirators (and all PPE) should only
be considered after all other measures have been taken to reduce
exposures. As discussed in Units IV.A. and V.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 most conditions of use and a
WCPP for certain occupational conditions of use. 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 IV.A.2. and
V.A.1.b.
In accordance with the approach described earlier in Unit II.C.3.,
EPA intends for this regulation to be as consistent 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 0.14 ppm as an 8-hour TWA to address unreasonable
risk for chronic cancer and non-cancer and acute non-cancer inhalation
endpoints. EPA recognizes that for PCE, the 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 PCE is a lower value than the OSHA PEL (and
other existing OELs, discussed in Unit II.C.5.) for many reasons,
including the age of the data and studies the values are based on and
that the values may not fully capture either the complete database of
studies considered in the 2020 Risk Evaluation for PCE or more recent
advances in modeling and scientific interpretation of toxicological
data applied in the calculation of the PCE ECEL. EPA considers the PCE
ECEL to represent the best available science under TSCA section 26(h)
because it was derived from information in the 2020 Risk Evaluation for
PCE, which was subject to peer review, and which is the result of a
systematic review process that investigated the reasonably available
information in order to identify relevant adverse health effects.
Additionally, by using the information from the 2020 Risk Evaluation
for PCE, the ECEL incorporates advanced modeling and peer-reviewed
methodologies, and accounts for exposures to potentially exposed and
susceptible subpopulations, as required by TSCA.
For PCE, the EPA ECEL is an 8-hour occupational inhalation exposure
limit based on chronic non-cancer neurotoxicity effects, and takes into
consideration the uncertainties identified in the 2020 Risk Evaluation
for PCE (Ref. 10). The ECEL represents the concentration at which an
adult human, including a member of a PESS, would be unlikely to suffer
adverse effects if exposed for a working lifetime. EPA has determined
as a matter of risk management policy that ensuring exposures remain at
or below the ECEL will eliminate any unreasonable risk of injury to
health from occupational inhalation exposures. In addition to the ECEL,
as part of this rulemaking EPA is proposing an ECEL action level, a
value half of the ECEL, that would trigger additional monitoring to
ensure that workers are not exposed to concentrations above the ECEL.
For PCE, the ECEL of 0.14 ppm is based on the most sensitive point
of departure across acute, chronic non-cancer, and cancer endpoints.
Neurotoxicity based on visual and cognitive deficits following chronic
exposure was the basis of the PCE ECEL based on epidemiological data
from Cavalleri et al., 1994 and Echeverria et al., 1995 (Refs. 10, 1,
11, 12). The ECEL incorporates a benchmark margin of exposure of 100 to
account for human variability and the absence of a no-effect level in
the studies.
The OSHA PEL for PCE 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). A 1989 update to 25 ppm
based on a quantitative cancer risk assessment and technological
feasibility analysis was later vacated by court order, reverting to the
original PEL of 100 ppm (Ref. 13); (See also 54 FR 2332, 2686, 2688
(1989)). The basis of the 100
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ppm PEL is unclear, however most original PELs were based on acute
health effects only observable at higher concentrations as more
sensitive chronic studies, including the chronic exposure studies used
to inform the PCE ECEL, 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 VII.D., the TSCA ECEL represents the best available
science at time of publication of the 2020 Risk Evaluation for PCE. As
described earlier, in a 2014 request for information OSHA described
how, while new developments in science and technology from the time the
PEL for PCE 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 PCE and it remains
frozen at the level that was originally adopted in 1971 (79 FR 61383,
October 10, 2014).
5. PCE and Other Occupational Exposure Limits
EPA is aware of other OELs for PCE, 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 recommended by the ACGIH is 25 ppm. This TLV is
based on ``discomfort and subjective complaints'' occurring at 100 ppm
and above (Ref. 14). Neurological effects such as dizziness, headache,
sleepiness, and incoordination were also indicated at 100 ppm and
above. The TLV appears to use a four-fold ``margin of safety''
consistent with other TLV reports but lower than what would be
recommended by EPA guidance (Ref. 15), which would support a downward
adjustment of 30x-100x. The TLV report acknowledges that the liver
effects were observed at as low as 9 ppm in mice after only 30 days of
continuous exposure, however ACGIH determined that the exposure pattern
was not representative of occupational scenarios. Additionally,
quantitative risks from cancer were not considered because PCE was
classified as only an animal carcinogen. Notably, the TLV report did
not cite either epidemiological study used as the basis of the EPA
ECEL, despite them being published 1-2 years prior to the 1996 TLV
update.
The Cal/OSHA PEL is 25 ppm, lower than the OSHA PEL and equivalent
to the ACGIH TLV. The 25 ppm value is also equivalent to the vacated
1989 OSHA PEL, which was based on a quantitative cancer risk assessment
and technological feasibility analysis. Despite the Cal/OSHA PEL being
equivalent to the vacated 1989 OSHA PEL based on cancer, Cal/OSHA did
not perform a quantitative cancer risk assessment and the PEL is
primarily based on non-cancer central nervous systems (CNS) effects
(Ref. 16).
In 1976, the NIOSH REL for PCE was 50 ppm as a TWA for up to a 10-
hour workday, 40-hour workweek (Ref. 17). This REL was considered
protective of neurological effects as well as eye and respiratory tract
irritation. The current REL for PCE is ``Ca (potential occupational
carcinogen) minimize workplace exposure concentrations'' (Ref. 18). As
described in NIOSH's Appendix A, this non-quantitative value is based
on the lowest feasible concentration (Ref. 19).
D. Summary of EPA's Risk Evaluation Activities on PCE
In December 2016, EPA selected PCE as one of the first 10 chemicals
for risk evaluation under TSCA section 6 (15 U.S.C. 2605). EPA
published the scope of the PCE risk evaluation in June 2017 (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 May 2020, EPA published a draft risk
evaluation(85 FR 26464, May 4, 2020) (FRL-10008-63), and after public
comment and peer review by the Science Advisory Committee on Chemicals
(SACC), EPA issued the 2020 Risk Evaluationfor PCE in December 2020 in
accordance with TSCA section 6(b) (85 FR 82474, December 18, 2020)
(FRL-10017-44). EPA subsequently issued a draft revised TSCA
unreasonable risk determination for PCE (87 FR 39085, June 30, 2022)
(FRL-9942-01-OCSPP), and after public notice and receipt of comments,
published a revised Unreasonable Risk Determination for PCE (87 FR
76481, December 14, 2022) (FRL-9942-01-OCSPP). The 2020 Risk Evaluation
for PCE and supplemental materials are in docket EPA-HQ-OPPT-2019-0502,
with the December 2022 revised unreasonable risk determination and
additional materials supporting the risk evaluation process in docket
EPA-HQ-OPPT-2016-0732, on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for PCE, EPA evaluated risks associated
with 61 conditions of use within the following categories: manufacture
(including import), processing, distribution in commerce, industrial
and commercial use, consumer use, and disposal. Descriptions of these
conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for PCE
identified significant adverse health effects associated with exposure
to PCE, including neurotoxicity effects from acute and chronic
inhalation exposures and dermal exposures, and cancer from chronic
inhalation exposures to PCE. A further discussion of the hazards of PCE
is in Unit III.B.2.
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 PCE, 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 PCE, EPA revised the original
unreasonable risk determination based on the 2020 Risk Evaluation for
PCE and issued a final revised unreasonable risk determination in
December 2022 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for PCE pursuant to TSCA section 6(b) and consistent
with Executive Order 13990 (entitled ``Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis'') and
other Administration priorities (Refs. 20, 21, and 22). The revisions
consisted of making the risk determination based on the whole chemical
substance instead of by 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 PCE 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
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irreversibility of the hazard); and uncertainties.
EPA determined that PCE presents an unreasonable risk of injury to
health. The unreasonable risk determination 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 PCE (i.e., during manufacture, processing,
industrial and commercial uses, or disposal); to children of employees
at dry cleaning facilities due to PCE exposures at those facilities;
and to consumers and bystanders associated with consumer uses of PCE
due to exposures from consumer use of PCE and PCE-containing products.
EPA did not identify risks of injury to the environment that drive the
unreasonable risk determination for PCE. The PCE conditions of use that
drive 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.1., with descriptions to
aid chemical manufacturers, processors, and users in determining how
their particular use or activity would be addressed under the proposed
regulatory provisions.
While the 2020 Risk Evaluation for PCE estimated different risks
for occupational non-users and workers, the benchmark (and thus the
ECEL value) is the same for both populations. That is, while workers
and occupational non-users may have different exposure patterns, the
level of exposure such that risks are no longer unreasonable is the
same for both workers and occupational non-users. Thus, for the
purposes of risk management, the distinction between worker and
occupational non-user is no longer relevant, and both are encompassed
by the definition of a potentially exposed person, as outlined in Unit
IV.A.2.a.
3. Fenceline Screening Analysis
The 2020 Risk Evaluation for PCE 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 December 2020 Risk
Evaluation for PCE) (Refs. 1, 2). This resulted in the surface water,
drinking water, and ambient air pathways for PCE 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 would lead to a failure to identify and protect
fenceline communities (Refs. 9, 23). EPA then conducted a screening
analysis to identify whether there may be potential risks to people
living near the fenceline of facilities releasing PCE.
In order to assess the potential risk to the general population in
proximity to a facility releasing PCE, 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. 24).
This analysis is discussed in Unit VI.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or any combination of such activities,
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more of the following requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (TSCA section
6(a)(1)).
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
<bullet> Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
<bullet> Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
<bullet> Require manufacturers and processors of the substance or
mixture to make and retain certain records, or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
<bullet> Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
<bullet> Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk
found to be present in the 2020 Risk Evaluation for PCE and the final
revised unreasonable risk determination, so that PCE no longer presents
such unreasonable risk. EPA's proposed regulatory action and two
alternative regulatory actions are described in Unit IV. EPA is
requesting public comment on all elements of the proposed regulatory
action and the alternative regulatory actions 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 timelines 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
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the need for an exemption and is proposing that a TSCA section 6(g)
exemption is warranted for certain conditions of use, as detailed in
Unit IV.A.5. EPA is requesting comment on the proposed rule's section
6(g) exemption provisions and rationale. In addition, EPA has found
that two TSCA section 6(g) exemptions may be warranted if the second
alternative regulatory action considered by EPA is adopted in the final
rule. Therefore, the public should assume that if EPA were to
promulgate the second alternative to the proposed regulatory action,
EPA would at the same time grant an exemption from the rule
requirements for two conditions of use under TSCA section 6(g). Unit
IV.B.2.b. includes information regarding EPA's second alternative
action that includes exemptions under TSCA section 6(g). 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 (e.g., a WCPP) and the primary and
second alternative regulatory actions, 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 V.
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 V.B.
includes more information regarding EPA's consideration of
alternatives, and Unit VI. provides 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, 2020, 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. 25). During the consultation, participants and EPA
discussed additional reporting requirements as a risk management tool
to address the unreasonable risk, EPA's consideration of safer
alternatives, and potential impacts to drinking water utilities (Ref.
25).
PCE 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. 26). 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, EPA discussed risk management
under TSCA section 6(a), findings from the 2020 Risk Evaluation for
PCE, types of information that would be helpful to inform risk
management, principles for transparency during the risk management
process, and types of information EPA is seeking from Tribes (Ref. 26).
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 PCE, such as minority
populations, low-income populations, and indigenous peoples. EPA's
Environmental Justice (EJ) consultation occurred from June 3, 2021,
through August 20, 2021. On June 16, 2021, and July 6, 2021, EPA held
public meetings as part of this consultation. These meetings were held
pursuant to and in compliance with Executive Orders 12898 and 14008.
EPA received five written comments following the EJ meetings, in
addition to oral comments provided during the consultation (Refs. 27,
28, 29, 30, 31). In general, commenters supported strong outreach to
affected communities, encouraged EPA to follow the hierarchy of
controls utilized by the industrial hygiene community, favored
prohibitions, and noted the uncertainty, and in some cases inadequacy,
of PPE. Commenters also urged EPA to address in this rulemaking ongoing
releases from hazardous waste and disposal sites, in particular vapor
intrusion of PCE from contaminated groundwater, soil, and indoor air.
Additionally, commenters expressed concern that the adverse health
impacts of PCE dry cleaning fall disproportionately to owners and
employees of minority owned small businesses, noted the viability of
professional wet cleaning as an alternative to PCE dry cleaning, and
urged EPA to consider adverse economic impacts of the regulation and
establishing a financial program to offset transition costs to local
communities (Ref. 32).
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. 33). EPA met with SERs before and during Panel
proceedings, on September 26, 2022, and November 10, 2022. Panel
recommendations are in Unit X.C. and in the Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 34), the Panel report is in the
docket (Ref. 33). EPA requests comment on all elements of the IRFA,
and, in particular, the flexibilities that EPA has identified following
input from the SERs during the SBAR process. Additional requests for
comment based on Panel recommendations are in Unit VIII.
Units X.C., X.E., X.F., and X.J. provide more information regarding
the consultations.
2. Other Stakeholder Engagement
In addition to the formal consultations described in Unit X., EPA
held a webinar on January 14, 2021, providing an overview of the TSCA
risk management process and the risk evaluation findings for PCE. EPA
also presented on the risk evaluation and risk management under TSCA
for PCE at a Small Business Administration (SBA) Office of Advocacy
Environmental roundtable on January 15, 2021. At both events, EPA staff
provided an overview of the TSCA risk management process and the
findings in the 2020 Risk Evaluation for PCE (Ref. 35). Attendees of
these meetings were given an opportunity to voice their concerns
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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 PCE. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 36); 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 PCE; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to PCE under the
conditions of use; understand the importance of PCE 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 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. 36).
3. Children's Environmental Health
The EPA 2021 Policy on Children's Health (Ref. 37) 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 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 PCE no longer
presents an unreasonable risk (including unreasonable risk to PESS).
The 2020 Risk Evaluation for PCE evaluated the hazards of PCE to
toddlers and older children (11-15 years and 16-20 years) and did not
find disproportionate adverse health impacts to these groups (Ref. 1).
Evidence of hazards to infants and males and females of reproductive
age was found for reproductive and developmental toxicity. The
reproductive and developmental health effects of concern related to
exposures to PCE are reduced sperm quality, spontaneous abortion, and
decreased fetal/placental weight. The most sensitive non-cancer hazard
driving the unreasonable risk for PCE is neurotoxicity (CNS effects).
Early lifestage development of the nervous system can be a sensitive
period, however the studies on PCE do not provide sufficient evidence
of greater sensitivity to neurotoxicity in early lifestages than later
lifestages, such as during adulthood. While the literature contains
methodological limitations in human studies, animal studies were
considered adequate to represent reproductive and development effects
in the 2020 Risk Evaluation for PCE.
The 2020 Risk Evaluation for PCE released in December 2020
considered impacts on both children and adults from occupational and
consumer use from inhalation and dermal exposures, as applicable. For
occupational use, the risk evaluation considered males (>16 years of
age) and females of reproductive age (>16 years of age to less than 50
years of age) for both dermal and inhalation exposures. Additionally,
because many dry cleaners are family owned and operated, the risk
evaluation assumed children of employees may spend the full workday at
dry cleaning facilities, in particular those too young to be in school,
during which time they may be exposed to similar air concentration
levels as ONUs. The risk evaluation considered inhalation exposures to
children of employees present at dry cleaners by evaluating central
nervous system effects for the most sensitive lifestage: infants less
than one year old. Children of employees present at dry cleaners would
be exposed to higher PCE concentrations than children who live or
attend daycare or school above or adjacent to dry cleaners, and EPA
therefore expects that risks to those populations are covered by
evaluation of children within dry cleaning facilities. For consumer
use, EPA evaluated dermal exposures for children ages 11 to 15 and 16
to 20 years of age and adults >20 years of age, and the evaluation of
bystander exposure from inhalation exposures includes infants, toddlers
and older children. While risks to children are not disproportionate,
effects observed in studies include central nervous system effects from
acute inhalation exposure.
B. Regulatory Assessment of PCE
1. Description of Conditions of Use
This unit describes the TSCA conditions of use that drive EPA's
unreasonable risk determination for the chemical substance PCE.
Condition of use descriptions were obtained from EPA sources such as
CDR use codes, the 2020 Risk Evaluation for PCE 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 PCE, the 2020 Risk
Evaluation for PCE, and supplemental files (Refs. 38, 1, 39). EPA
acknowledges that some of the terms in this unit may be defined under
other statutes, however the descriptions here are intended to provide
clarity to the regulated entities who will implement the provisions of
this rulemaking under TSCA section 6(a).
a. Manufacturing (Including Import)
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
PCE 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. 40).
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 PCE in chemical reactions for the manufacturing of
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another chemical substance or product. Through processing as a reactant
or intermediate, PCE serves as a feedstock in the production of another
chemical product via a chemical reaction in which PCE is completely
consumed. For example, PCE is used as a reactant in the production of
HFCs, hydrochlorofluorocarbons (HCFCs), and chlorofluorocarbons (CFCs).
This condition of use includes reuse of PCE, including PCE originally
generated as a byproduct or residual PCE as a reactant.
ii. Processing into formulation, mixture or reaction product in
cleaning and degreasing products. This condition of use refers to when
PCE is added to a cleaning or degreasing product (or product mixture)
prior to further distribution of the product. For example, formulators
may mix PCE at varying concentrations with other additives to formulate
cleaning or degreasing products that are used to remove dirt and
dissolve oils, greases, and similar materials from textiles, glassware,
metal surfaces, furniture, furnishings, and other articles, or to
cleanse, sanitize, bleach, scour, polish, protect, or improve the
appearance of surfaces.
iii. Processing into formulation, mixture or reaction product in
adhesive and sealant products. This condition of use refers to when PCE
is added to an adhesive or sealant product (or product mixture) prior
to further distribution of the product. For example, formulators may
mix PCE at varying concentrations with other additives to formulate
products that promote bonding between other substances, promote
adhesion of surfaces, or prevent seepage of moisture or air.
iv. Processing into formulation, mixture or reaction product in
paint and coating products. This condition of use refers to when PCE is
added to a paint or coating product (or product mixture) prior to
further distribution of the product. For example, formulators may mix
PCE at varying concentrations with other additives to formulate paint
and coating products that are applied to surfaces to enhance properties
such as water repellency, gloss, fade resistance, ease of application,
or foam prevention. Additionally, PCE is incorporated into coating
products, such as maskant, that protect a substrate during exposure to
a chemical process such as chemical milling, plating, and anodizing.
v. Processing into formulation, mixture or reaction product in
other chemical products and preparations. This condition of use refers
to when PCE is added to other chemical products (or product mixtures)
or preparations prior to further distribution of the product. For
example, formulators may mix PCE at varying concentrations with other
additives to formulate inks, toners, colorants, photographic supplies,
lubricants, greases, mold releases, and other products.
vi. Processing by repackaging. This condition of use refers to the
preparation of a chemical substance or mixture for distribution in
commerce in a different form, state, or quantity. This includes
transferring of PCE from a bulk container into smaller containers.
vii. Recycling. This condition of use refers to processing waste
streams of PCE at a third-party site for the purpose of recovering
materials or otherwise preparing the waste for reuse instead of
disposal. Waste 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 industrial and
commercial use of PCE as a solvent for cleaning and degreasing through
the process of heating PCE to its volatilization point and using its
vapors to remove dirt, oils, greases, and other surface contaminants
from metal and other parts using batch open-top vapor degreaser
machines.
ii. Industrial and commercial use as solvent for closed-loop batch
vapor degreasing. This condition of use refers to the industrial and
commercial use of PCE as a solvent for cleaning and degreasing through
the process of heating PCE to its volatilization point and using its
vapors to remove dirt, oils, greases, and other surface contaminants
from metal and other parts using batch closed-loop degreaser machines.
iii. Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing. This condition of use refers to the
industrial and commercial use of PCE as a solvent for cleaning and
degreasing through the process of heating PCE to its volatilization
point and using its vapors to remove dirt, oils, greases, and other
surface contaminants from metal and other parts using in-line
conveyorized vapor degreaser machines.
iv. Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing. This condition of use refers to the
industrial and commercial use of PCE as a solvent for cleaning and
degreasing through a process of heating PCE to its volatilization point
and using its vapors to remove dirt, oils, greases, and other surface
contaminants from metal and other parts using web vapor degreaser
machines.
v. Industrial and commercial use as solvent for cold cleaning. This
condition of use refers to the industrial and commercial use of PCE as
a non-boiling solvent in cold cleaning machines, including simple spray
sinks and dip tanks, to remove dirt, oils, greases, and other surface
contaminants from metal and other parts.
vi. Industrial and commercial use as solvent for aerosol spray
degreaser/cleaner. This condition of use refers to the industrial and
commercial use of PCE as a solvent in degreasing and cleaning products
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,
metals, and other fabricated materials. This description includes use
of PCE in products for energized electrical cleaning for equipment with
an electrical current running through it, such as electric motors,
armatures, relays, electric panel, generators, and other equipment.
This description does not apply to use of PCE in products intended for
automotive care, welding, or mold cleaning, which are described in
different conditions of use.
vii. Industrial and commercial use as a solvent for aerosol
lubricants. This condition of use refers to the industrial and
commercial use of PCE in aerosolized products to reduce friction, heat
generation and wear between solid surfaces.
viii. Industrial and commercial use as a solvent for penetrating
lubricants and cutting tool coolants. This condition of use refers to
the industrial and commercial use of PCE in liquid products such as
metalworking, cutting, and tapping fluids, including penetrating
lubricants and cutting tool coolants, to reduce friction, heat
generation and wear between solid surfaces.
ix. Industrial and commercial use in solvent-based adhesives and
sealants. This condition of use refers to the industrial and commercial
use of PCE as a solvent 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 in solvent-based paints and
coatings. This condition of use refers to the industrial and commercial
use of PCE as a solvent in paint and coating, including maskant, that
is applied to surfaces to enhance properties such as water repellence,
increased gloss, improved fade
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resistance, ease of application, and foam prevention. This description
does not apply to the use of PCE in maskant for chemical milling, which
is described in a different condition of use
xi. Industrial and commercial use in maskant for chemical milling.
This condition of use refers to the industrial and commercial use of
PCE as a solvent in maskants or elastomer-based coatings that are used
to protect a substrate during exposure to a chemical process, such as
chemical milling, plating and anodizing.
xii. Industrial and commercial use as a processing aid in
pesticide, fertilizer and other agricultural chemical manufacturing.
This condition of use refers to the industrial and commercial use of
PCE to improve the processing characteristics or the operation of
process equipment or to alter or buffer the pH of the substance of
mixture during the production of non-pesticidal products used to
increase the productivity and quality of plant, animal and forestry
crops produced on a commercial scale. Processing aids are added to a
reaction mixture to aid in the manufacture or synthesis or another
chemical substance but are not intended to remain in or become part of
the product or product mixture or affect the function of a substance or
article created.
xiii. Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing. This condition of use
refers to the industrial and commercial use of PCE to improve
processing characteristics or the operation of process equipment during
the production of oil, gas, and other similar products. For example,
PCE is used in both reforming and isomerization processes at
refineries. In the reforming process, PCE is added directly to a
regenerator in a Continuous Catalytic Regeneration reforming unit, and
in the isomerization process, PCE is added to the hydrocarbon feed. In
both processes, PCE provides chlorine ions to regenerate the catalysts
and is consumed in the process.
xiv. Industrial and commercial use in wipe cleaning. This condition
of use refers to the industrial and commercial use of PCE in non-
aerosol 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.
xv. Industrial and commercial use in other spot cleaning and spot
removers, including carpet cleaning. This condition of use refers to
the industrial and commercial use of PCE in products to remove dirt,
grease, stains, spots, and foreign matter from furniture and furnishes,
including carpets and rugs. This description does not apply to the use
of PCE as a spot cleaner at dry cleaning facilities, which is described
under other conditions of use.
xvi. Industrial and commercial use in mold release. This condition
of use refers to the industrial and commercial use of PCE in products
to remove dirt, grease, stains, spots, and foreign matter, including
release agent residues, from molds and casting surfaces.
xvii. Industrial and commercial use in dry cleaning and spot
cleaning post-2006 dry cleaning. This condition of use refers to
industrial and commercial use of PCE in products for spot cleaning and
as a solvent in degreasing and cleaning applications to remove dirt,
grease, stains, spots, and foreign matter from garments at dry cleaning
facilities that use PCE dry cleaning machines after the promulgation of
the 2006 PCE NESHAP for Dry Cleaning Facilities (40 CFR part 63,
subpart M). This includes dry cleaning facilities using third
generation (dry-to-dry, non-vented machines with refrigerated
condensers), fourth generation (dry-to-dry, non-vented machines with
both refrigerated condensers and carbon adsorbers as secondary vapor
controls), or fifth generation (dry-to-dry, non-vented machines with
secondary vapor controls, a monitor inside the machine drum, and an
interlocking system to ensure the concentration is below approximately
300 ppm before the loading door can be opened) PCE dry cleaning
machines.
xviii. Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th gen only dry cleaning. This condition of use refers to
industrial and commercial use of PCE in products for spot cleaning and
as a solvent in degreasing and cleaning applications to remove dirt,
grease, stains, spots, and foreign matter from garments at dry cleaning
facilities that use fourth generation or fifth generation PCE machines.
In addition to use as a solvent in dry cleaning equipment, PCE is found
in products to spot clean garments to remove stains or spots before and
after dry cleaning treatment.
xix. Industrial and commercial use in automotive care products
(e.g., engine degreaser and brake cleaner). This condition of use
refers to the industrial and commercial use of PCE in aerosolized
products to remove dirt, grease, stains, and foreign matter from
interior and exterior vehicle surfaces. This description includes use
of products for motorized vehicle maintenance and their parts, but does
not include energized electrical cleaners, which is covered by the
industrial and commercial use as a solvent for aerosol spray degreaser/
cleaner. Additionally, this description does not include use of non-
aerosolized products intended for automotive care, which are covered by
different conditions of use.
xx. Industrial and commercial use in non-aerosol cleaner. This
condition of use refers to the industrial and commercial use of PCE in
non-aerosol products to remove dirt, grease, stains, and foreign matter
from furniture, furnishings, interior or exterior vehicles, and other
materials, or to clean, sanitize, bleach scour, polish, or improve the
appearance of surfaces in all other applications not specified
elsewhere in this section.
xxi. Industrial and commercial use in metal (e.g., stainless steel)
and stone polishes. This condition of use refers to the industrial and
commercial use of PCE in non-aerosolized products for metal (e.g.,
stainless steel) and stone polishing applications, including stone and
marble cleaner and wax.
xxii. Industrial and commercial use in laboratory chemicals. This
condition of use refers to the industrial and commercial use of PCE,
often in small quantities, in a laboratory process or in specialized
laboratory equipment for instrument calibration/maintenance chemical
analysis, chemical synthesis, extracting and purifying other chemicals,
dissolving other substances, executing research, development, test and
evaluation methods, and similar activities.
xxiii. Industrial and commercial use in welding. This condition of
use refers to the industrial and commercial use of PCE in welding
applications. For example, PCE can be found in aerosolized products
that cast or join materials, promote the fusing of minerals, and
prevent oxide formation, including products that reduce welding spatter
or prevent the spatter from sticking to surfaces.
xxiv. Industrial and commercial use in other textile processing.
This condition of use refers to the industrial and commercial use of
PCE in processing textile products not described elsewhere. For
example, PCE is used as a scourer and for sizing and finishing of
cloth.
xxv. Industrial and commercial use in wood furniture manufacturing.
This condition of use refers to the industrial and commercial use of
PCE in the manufacture of wood furniture or wood furniture components
(including household furniture, wood office furniture, wood containers
and pallets,
[[Page 39666]]
and all other wood products) not described elsewhere.
xxvi. Industrial and commercial use in foundry applications. This
condition of use refers to the industrial and commercial use of PCE in
metal foundry, smelting, and metallurgical applications not described
elsewhere, such as soldering/desoldering, at nonferrous metal foundries
(except die-casting), nonferrous metal diecasting foundries, aluminum
foundries, and iron foundries.
xxvii. Industrial and commercial use in specialty Department of
Defense uses (oil analysis and water pipe repair). During the risk
evaluation, the Department of Defense (DOD) provided monitoring data
for PCE in various uses, including for oil analysis and water pipe
repair. This condition of use refers to the industrial and commercial
use of PCE in specialty DOD uses in oil analysis and water pipe repair.
After the risk evaluation was published, DOD determined there is no
current data to indicate that PCE is required for these specialty uses.
xxviii. Commercial use in inks and ink removal products (based on
printing). This condition of use refers to the commercial use of PCE in
ink and ink removal products used in printing for writing, printing, or
creating an image on paper and other substrates, applied to substrates
to change their color or hide images, or to remove dirt and other
contaminants from substrates such as cleaning machines or printing
plates, at print shops.
xxix. Commercial use in inks and ink removal products (based on
photocopying). This condition of use refers to the commercial use of
PCE in ink and ink removal products used in photocopying for writing,
printing, creating an image on paper and other substrates, applied to
substrates to change their color or hide images, or to remove dirt and
other contaminants from substrates such as cleaning machines or
printing plates.
xxx. Commercial use in photographic film. This condition of use
refers to the commercial use of PCE in photographic supplies, film,
photoprocessing chemicals, and photographic paper. For example, PCE is
used as a liquid-gate fluid to help protect scratching of optical
negatives during filming.
xxxi. Commercial use in metal mold cleaning, release and protectant
products. This condition of use refers to the commercial use of PCE in
mold release products to create barriers to prevent certain materials
from adhering to each other. This description does not apply to the use
of PCE in mold cleaning products that remove residual coatings from
mold release, which is described under a different condition of use.
d. Consumer Use
i. Consumer use in cleaners and degreasers (other). This condition
of use refers to the consumer use of PCE as a solvent in degreasing and
cleaning products use 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, metals, and other fabricated materials
not described elsewhere in this section.
ii. Consumer use in dry cleaning solvent. This condition of use
refers to consumer exposure to PCE used to remove dirt, grease, stains,
spots, and foreign matter from garments via dry cleaning, in particular
the transportation, storage, and wear of articles that were dry cleaned
with PCE. For example, garments that are dry cleaned at facilities that
use PCE as a dry cleaning solvent have residual concentrations of PCE
remaining in the article after a dry cleaning event.
iii. Consumer use in automotive care products (brake cleaner). This
condition of use refers to the consumer use of PCE in aerosolized
products to remove dirt, grease, stains, and foreign matter from
interior and exterior vehicle surfaces, including brake cleaner.
iv. Consumer use in automotive care products (parts cleaner). This
condition of use refers to the consumer use of PCE in non-aerosolized
products that are to remove dirt, grease, stains, and foreign matter
from interior and exterior vehicle surfaces, including parts cleaner.
v. Consumer use in aerosol cleaner (vandalism mark and stain
remover). This condition of use refers to the consumer use of PCE in
aerosolized products for cleaning and furniture care, including
vandalism mark and stain remover.
vi. Consumer use in non-aerosol cleaner (e.g., marble and stone
polish). This condition of use refers to the consumer use of PCE in
non-aerosolized products for cleaning and furniture care, typically in
the form of a solid or liquid cleaner not described elsewhere in this
section, including liquid marble and stone polish.
vii. Consumer use in lubricants and greases (cutting fluid). This
condition of use refers to the consumer use of PCE in non-aerosolized
products to reduce friction, heat generation and wear between solid
surfaces, including cutting fluid.
viii. Consumer use in lubricants and greases (lubricants and
penetrating oils). This condition of use refers to the consumer use of
PCE in aerosolized products to reduce friction, heat generation and
wear between solid surfaces, including lubricant and penetrating oils.
ix. Consumer use in adhesives for arts and crafts (including
industrial adhesive, arts and crafts adhesive, gun ammunition sealant).
This condition of use refers to the consumer use of PCE as an adhesive
in arts, crafts, and hobby products to promote bonding between other
substances, promote adhesion of surfaces, or prevent seepage of
moisture or air, in particular industrial adhesive, adhesive for arts
and crafts, and gun ammunition sealant. For example, PCE may be used in
gun ammunition sealant products to ensure no moisture gets into
ammunition casings.
x. Consumer use in adhesives for arts and crafts (livestock
grooming adhesive). This condition of use refers to the consumer use of
PCE in livestock grooming adhesive spray.
xi. Consumer use in adhesives for arts and crafts (column adhesive,
caulk and sealant). This condition of use refers to the consumer use of
PCE for column adhesive, caulk and sealant.
xii. Consumer use in solvent-based paints and coatings (outdoor
water shield (liquid)). This condition of use refers to the consumer
use of PCE in solvent-based non-aerosol paint and coating products to
enhance properties such as water repellence, increased gloss, improved
fade resistance, ease of application, or foam prevention, in particular
the use in outdoor water shield sealants and coatings.
xiii. Consumer use in solvent-based paints and coatings (coating
and primers (aerosol)). This condition of use refers to the consumer
use of PCE in solvent-based paint and coating aerosol products to
enhance properties such as water repellence, increased gloss, improved
fade resistance, ease of application, or foam prevention, in particular
the use in aerosolized coating and primers.
xiv. Consumer use in solvent-based paints and coatings (rust primer
and sealant (liquid)). This condition of use refers to the consumer use
of PCE in solvent-based paint and coating liquid products to enhance
properties such as water repellence, increased gloss, improved fade
resistance, ease of application, or foam prevention, in particular the
use in liquid rust primer and sealant.
xv. Consumer use in solvent-based paints and coatings (metallic
overglaze). This condition of use refers to the consumer use of PCE in
solvent-based paint and coating products to enhance
[[Page 39667]]
properties such as water repellence, increased gloss, improved fade
resistance, ease of application, or foam prevention, in particular the
use in solvent based metallic overglaze for ceramics.
xvi. Consumer use in metal (e.g., stainless steel) and stone
polishes. This condition of use refers to the consumer use of PCE in
liquid wax-based products for metal (e.g., stainless steel) and stone
polishing.
xvii. Consumer use in inks and ink removal products. This condition
of use refers to the consumer use of PCE in ink and ink removal
products for writing, printing, creating an image on paper and other
substrates, applied to substrates to change their color or hide images,
or to remove dirt and other contaminants from substrates.
xviii. Consumer use in welding. This condition of use refers to the
consumer use of PCE in products that cast or join materials, promote
the fusing of minerals, or prevent oxide formation, including products
that reduce welding spatter or prevent the spatter from sticking to
surfaces.
xix. Consumer use in metal mold cleaning, release and protectant
products. This condition of use refers to the consumer use of PCE in
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, machinery, electrical and
electronic equipment, pins, and mechanical equipment.
e. Disposal
This condition of use refers to the process of disposing generated
waste streams of PCE that are collected and transported to a third-
party site for their final disposition, such as waste incineration or
landfilling.
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 PCE for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority Congress gave to the Agency to
``regulat[e] any manner or method of commercial use'' under TSCA
section 6(a)(5) to reach both industrial and commercial uses.
Additionally, in the 2020 Risk Evaluation for the chemical
substance PCE, EPA identified and assessed all known, intended, and
reasonably foreseen industrial, commercial, and consumer uses of PCE in
order to determine whether PCE as a whole chemical substance presents
unreasonable risks to health and the environment. EPA determined that
all industrial, commercial, and consumer uses of PCE evaluated in the
2020 Risk Evaluation for PCE drive the EPA determination that PCE
presents 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 of PCE. 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
PCE 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 PCE whereas the regulatory text applies to all TSCA 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 PCE that would not be prohibited, and, if so,
whether the descriptions in this unit are consistent with the
conditions of use evaluated in the 2020 Risk Evaluation for PCE 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 that contains a list of the industrial and commercial
conditions of use evaluated in the 2020 Risk Evaluation for PCE.
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 PCE 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 PCE, EPA identified non-
cancer adverse effects from acute and chronic inhalation and dermal
exposures to PCE, and cancer from chronic inhalation and dermal
exposures to PCE (Ref. 1). EPA identified neurotoxicity as the most
robust and sensitive endpoint for non-cancer adverse effects from acute
inhalation and dermal exposures and as the most robust and sensitive
endpoint for non-cancer adverse effects from chronic inhalation and
dermal exposures for all conditions of use (Ref. 1). Additional risks
associated with other adverse effects (e.g., kidney, liver, immune
system, and developmental toxicity) were identified for acute and
chronic exposures. EPA also concluded, based on EPA's Guidelines for
Carcinogen Risk Assessment (Ref. 41), that PCE is likely to be
carcinogenic to humans by all routes of exposure and calculated cancer
risks from chronic inhalation and dermal exposures. Unit VI.A.
summarizes the health effects and the magnitude of exposures (Ref. 1).
To make the unreasonable risk determination for PCE, EPA evaluated
exposures to workers, ONUs, children of workers at dry cleaners,
consumer users, and bystanders to consumer use using reasonably
available monitoring and modeling data for inhalation and dermal
exposures (Ref. 2). 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 VI.A.
For the 2020 Risk Evaluation for PCE, EPA considered PESS. EPA
identified the following groups as PESS: workers, ONUs, children of
workers at dry cleaners, consumers, bystanders, developing fetuses (and
by extension, women of childbearing age), and those with certain pre-
existing health conditions, higher body fat content, or particular
genetic polymorphisms (Ref. 1). All PESS are included in the
quantitative and qualitative analyses described in the risk evaluation,
and were considered in the determination of unreasonable risk for PCE.
As discussed in Unit II.D. and Unit VI.A., the 2020 Risk Evaluation for
PCE excluded the air and water exposure pathways to the general
population from the published
[[Page 39668]]
risk evaluations and may have caused some risks to be unaccounted for
in the risk evaluation. EPA considers these receptors a subset of the
general population and categorizes them as fenceline communities; they
may also be considered PESS. See Unit VI.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 eliminate the
unreasonable risk for PCE. This Unit summarizes the TSCA section 6
considerations for issuing regulations under TSCA section 6(a). Unit V.
outlines how EPA applied these considerations specifically to managing
the unreasonable risk from PCE.
As required, EPA developed a proposed regulatory action and one or
more primary alternative regulatory actions, which are described in
Units IV.A. and IV.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 PCE at different points in the supply chain to eliminate
exposures or restrict the availability of PCE and PCE-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: (i) The effects of PCE on
health and the environment; (ii) The magnitude of exposure to PCE of
human beings and the environment; (iii) The benefits of PCE for various
uses; and (iv) 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 VI. 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 PCE to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a)
regulation could include alignment of requirements and definitions in
and under existing statutes 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 V.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory actions in Unit IV.).
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 PCE, 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 IV. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit V.
As demonstrated by the number of distinct programs addressed in
this rulemaking and the structure of this proposed rule in addressing
them independently, EPA generally intends the rule's provisions to be
severable from each other. EPA expects to provide additional detail on
severability in the final rule once the Agency has considered public
comments and finalized the regulatory language.
IV. Proposed and Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
PCE 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 PCE, the proposed regulatory action is
described in Unit IV.A. and the two alternative regulatory actions
considered are described in Unit IV.B. An overview of the proposed
regulatory action and two alternative regulatory actions for each
condition of use is in Unit IV.C. The rationale for the proposed and
alternative regulatory actions and associated compliance timeframes are
discussed in this unit and in more detail in Unit V.A.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to: Prohibit most
industrial and commercial uses and the manufacture (including import),
processing, and distribution in commerce of PCE for those uses,
outlined in Unit IV.A.1.a.; Prohibit the manufacture (including
import), processing, and distribution in commerce of PCE for all
consumer use, outlined in Unit IV.A.1.b.; Prohibit the manufacture
(including import), processing, distribution in commerce, and
commercial use of PCE in dry cleaning and spot cleaning through a 10-
year phaseout, outlined in Unit IV.A.1.c.; Require strict workplace
controls, including a PCE WCPP, which would include requirements to
meet an inhalation exposure concentration limit and prevent direct
dermal contact with PCE, for 16 occupational conditions of use not
prohibited, outlined in Unit IV.A.2.; Require prescriptive workplace
controls for laboratory use, outlined in Unit IV.A.3.; Establish
recordkeeping and downstream notification requirements, outlined in
Unit IV.A.4; and Provide a 10-year time limited exemption under TSCA
section 6(g) for certain critical or essential emergency uses of PCE
for which no technically and economically feasible safer alternative is
available, outlined in Unit IV.A.5. As the manufacture and processing
of PCE presents an unreasonable risk to health in the
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United States, the manufacture and processing of PCE for export would
also be prohibited or restricted in accordance with TSCA section
12(a)(2).
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce,
and Use
a. Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution in Commerce of PCE for
Those Uses
EPA is proposing to prohibit the manufacturing, processing,
distribution in commerce, and use of PCE for industrial and commercial
uses, except for those uses which would continue under the WCPP (as
described in Unit IV.A.2.), and laboratory use (as described in Unit
IV.A.3.). The proposed prohibitions under TSCA would not apply to any
use of PCE that is excluded from TSCA's definition of ``chemical
substance'' under TSCA section 3(2)(B)(ii) through (vi). This proposed
prohibition would include a prohibition on the manufacturing,
processing, distribution in commerce, and use of PCE for the following
industrial and commercial uses:
<bullet> As a processing aid in pesticide, fertilizer and other
agricultural chemical manufacturing;
<bullet> In specialty DOD uses (oil analysis and water pipe
repair);
<bullet> In solvent-based paints and coatings;
<bullet> As solvent for aerosol spray degreaser/cleaner;
<bullet> As solvent for cold cleaning;
<bullet> In other textile processing;
<bullet> In wood furniture manufacturing;
<bullet> As a solvent for aerosol lubricants;
<bullet> In wipe cleaning;
<bullet> In other spot cleaning and spot removers, including carpet
cleaning;
<bullet> In automotive care products (e.g., engine degreaser and
brake cleaner);
<bullet> In non-aerosol cleaner;
<bullet> In metal (e.g., stainless steel) and stone polishes;
<bullet> In foundry applications;
<bullet> In welding;
<bullet> For mold release;
<bullet> As a solvent for penetrating lubricants and cutting tool
coolants;
<bullet> For photographic film;
<bullet> In inks and ink removal products (based on printing);
<bullet> In inks and ink removal products (based on photocopying);
and
<bullet> In metal mold cleaning, release and protectant products.
EPA is also proposing to prohibit the following condition of use,
which is the upstream processing condition of use for some of the
prohibited industrial and commercial uses: processing into formulation,
mixture or reaction product in other chemical products and
preparations. EPA is also proposing to phase out the use of PCE at
industrial and commercial dry cleaning facilities as described in Unit
IV.A.1.c.
EPA has considered the sensitive nature of the DOD applications for
which EPA received monitoring data for the 2020 Risk Evaluation for
PCE, including for the industrial and commercial use in specialty DOD
uses (oil analysis and water pipe repair). The Agency understands that
DOD has no current data that indicate PCE is required for these
specialty uses and EPA has not identified any other entities using PCE
in this way. Because there are no known entities engaged in this
condition of use, EPA believes a prohibition is reasonable and would
prevent any future entities from engaging in this use. EPA is therefore
proposing to prohibit the manufacturing, processing, distribution in
commerce, and use of PCE for the industrial and commercial use in
specialty DOD uses (oil analysis and water pipe repair).
As discussed in Units III.B.3. and V.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, and the irreversible health effects associated with PCE
exposures, EPA has determined that prohibition is the best way to
address the unreasonable risk from PCE driven in part by the conditions
of use identified in this unit. 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, a prohibition on the
processing of PCE 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 is proposing to stagger the compliance dates for the proposed
prohibitions described in this unit, such that the requirements would
come into effect in 12 months for manufacturers, 15 months for
processers, 18 months for distributing to retailers, 21 months for all
other distributors (including retailers), and 24 months for industrial
and commercial users after the publication date of the final rule. When
proposing these compliance dates as required under TSCA section 6(d),
EPA considered irreversible health effects and risks associated with
PCE 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 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.
Additionally, EPA recognizes that there may be instances where an
ongoing use of PCE that has implications for national security or
critical infrastructure as it relates to other Federal agencies (e.g.,
DOD, NASA) is identified after the PCE rule is finalized, but the final
rule prohibits that use. For instances like that, EPA requests comments
on an appropriate, predictable, process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued using the tools
available under TSCA, aligning with the requirements of section 6(g).
One example of an approach could be the establishment by rulemaking of
a Federal agency category of use that would require implementation of
the WCPP and periodic reporting to EPA on details of the use as well as
progress in discontinuing the use or finding a suitable alternative. To
utilize the category of use a Federal agency would petition EPA,
supported by documentation describing the specific use (including
documentation of the specific need, service life of any relevant
equipment, and specific identification of any applicable regulatory
requirements or
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certifications, as well as the location and quantity of the chemical
being used); the implications of cessation of this use for national
security or critical infrastructure (including how the specific use
would prevent injuries/fatalities or otherwise provide life-supporting
functions); exposure control plan; and, for Federal agency uses where
similar adoption by the commercial sector may be likely, concrete steps
taken to identify, test, and qualify substitutes for the 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 requests comment on whether these are the
appropriate types of information for use in evaluating this type of
category of use, and whether there are other considerations that should
apply. EPA would make a decision on the petition within 30 days and
publish the decision in the Federal Register shortly after.
Additionally, during the year following the petition, EPA would take
public comment on the approved petition and no later than 180 days
after submitting the petition to EPA, the requesting agency would
submit monitoring data indicating compliance with the WCPP at each
relevant location as well as documentation of efforts to identify or
qualify substitutes. In the absence of that confirmatory data, the
utilization of the generic Federal agency category of use would expire
within one year of the date of receipt by EPA of the petition. EPA
could undertake a section 6(g) rulemaking for those instances where the
Federal agency could not demonstrate compliance with the WCPP. This is
just one example of a potential process. EPA requests comments on a
process that could expedite reconsideration for uses that Federal
agencies or their contractors become aware of after the final rule is
issued.
b. Prohibition of Manufacturing, Processing and Distribution in
Commerce of PCE for Consumer Use
In the 2020 Risk Evaluation for PCE, EPA evaluated consumer use of
PCE:
<bullet> In cleaners and degreasers (other);
<bullet> In automotive care products (brake cleaner);
<bullet> In automotive care products (parts cleaner);
<bullet> In aerosol cleaner (vandalism mark and stain remover);
<bullet> In non-aerosol cleaner (e.g., marble and stone polish);
<bullet> In lubricants and greases (cutting fluid);
<bullet> In lubricants and greases (lubricants and penetrating
oils);
<bullet> In adhesives for arts and crafts (including industrial
adhesive, arts and crafts adhesive, gun ammunition sealant);
<bullet> In adhesives for arts and crafts (livestock grooming
adhesive);
<bullet> In adhesives for arts and crafts (column adhesive, caulk
and sealant);
<bullet> In solvent-based paints and coatings (outdoor water shield
(liquid));
<bullet> In solvent-based paints and coatings (coatings and primers
(aerosol));
<bullet> In solvent-based paints and coatings (rust primer and
sealant (liquid));
<bullet> In solvent-based paints and coatings (metallic overglaze);
<bullet> In metal (e.g., stainless steel) and stone polishes;
<bullet> In inks and ink removal products;
<bullet> In welding; and
<bullet> In metal mold cleaning, release and protectant products.
The consumer uses evaluated in the 2020 Risk Evaluation for PCE
constitute all known, intended, and reasonably foreseen consumer uses
of PCE. EPA determined that all of these consumer uses drive
unreasonable risk of injury to health. As such, for purposes of this
risk management rulemaking, ``consumer use'' refers to all consumer
uses, including all known, intended, and reasonably foreseen consumer
uses of PCE. EPA is proposing to prohibit the manufacturing,
processing, and distribution in commerce of PCE for all consumer use.
EPA is proposing to phase out consumer use in dry cleaning solvent
(i.e., exposure to clothing or articles recently dry cleaned with PCE
as described in Unit III.B.1.d.ii.) by phasing out the use of PCE at
industrial and commercial dry cleaning facilities as described in Unit
IV.A.1.c.; thus, consumer use of clothing and articles that have been
commercially dry cleaned with PCE would not be subject to the
prohibitions and compliance timeframes described in this unit.
As discussed in Units III.B.3. and V.A., based on consideration of
the severity of the hazards of PCE in conjunction with the limited
options available to adequately address the identified unreasonable
risk to consumers and bystanders under TSCA section 6(a), EPA is
proposing to address the unreasonable risk from consumer use by
prohibiting the manufacturing (including import), processing, and
distribution in commerce of PCE for consumer use in order to remove PCE
and products containing PCE from the market, thereby effectively
eliminating instances of consumer use.
Additionally, EPA is proposing to prohibit retailers from
distributing in commerce PCE, including any PCE-containing products, in
order to prevent products intended for industrial and commercial use
under the WCPP outlined in Unit IV.A.2. from being purchased by
consumers. A retailer is any person or business entity that distributes
or makes available products to consumers, including through e-commerce
internet sales or distribution. If a person or business entity
distributes or makes available any product to at least one consumer,
then it is considered a retailer (as EPA proposes to define that term
in 40 CFR 751.5). For a distributor not to be considered a retailer,
the distributor must distribute or make available chemical substances
solely to commercial or industrial end-users or businesses. Prohibiting
manufacturers (including importers), processors, and distributors from
distributing PCE, or any products containing PCE, to retailers would
prevent retailers from making these products available to consumers,
which would help address that part of the unreasonable risk driven by
consumer use of PCE.
EPA is proposing that the prohibition described in this unit would
take effect in 12 months for manufacturers, 15 months for processers,
18 months for distributing to retailers, and 21 months for all other
distributors (including retailers) after the publication date of the
final rule in the Federal Register. EPA considered irreversible health
effects and risks associated with PCE exposure when proposing
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. EPA may finalize significantly shorter
or longer compliance timeframes based on consideration of public
comments.
c. Prohibition and Phaseout of PCE in Dry Cleaning
EPA is proposing to prohibit the manufacturing, processing,
distribution in commerce, and industrial and commercial use of PCE for
dry cleaning and spot cleaning, including in 3rd generation (dry-to-dry
machines with refrigerated condenser) and 4th/5th generation (dry-to-
dry machines with refrigerated condenser and carbon adsorber process
controls) machines.
[[Page 39671]]
As discussed in Units III.B.3. and V.A., based on a 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, and the irreversible health effects associated with PCE
exposures, EPA has determined that prohibition is the best way to
address the unreasonable risk. A prohibition on the manufacturing,
processing, distribution in commerce, and industrial and commercial use
of PCE in dry cleaning and spot cleaning would address the unreasonable
risk for the following conditions of use evaluated in the 2020 Risk
Evaluation and described further in Unit III.B.1:
<bullet> Industrial and commercial use in dry cleaning and spot
cleaning post-2006 dry cleaning;
<bullet> Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th generation only dry cleaning; and
<bullet> Consumer use in dry cleaning solvent (i.e., exposure to
clothing or articles recently dry cleaned with PCE).
EPA recognizes that the transition to an alternative dry cleaning
process or solvent could require significant time and investment from
dry cleaning facilities; therefore, EPA is proposing a phaseout period
to take place following the publication date of the final rule. The
phaseout would start with a prohibition on the use of PCE in any dry
cleaning machine acquired 6 months or later after the publication date
of the rule, followed by a prohibition on the use of PCE in 3rd
generation machines 3 years after the publication date of the rule.
Full implementation of the phaseout would be achieved with a
prohibition on the use of PCE in all dry cleaning and spot cleaning,
including in 4th and 5th generation machines, 10 years after the
publication date of the final rule and a prohibition on the
manufacturing, processing, and distribution in commerce of PCE for use
in dry cleaning solvent 10 years after the publication date of the
final rule. When proposing these compliance dates, EPA considered
reasonably available information, including market research, existing
State actions restricting the use of PCE in dry cleaning (Title 17,
California Code of Regulations 39109 and 93110; Minnesota HF 91; 6
NYCRR Part 232), and engagement with industry, trade associations, and
State and local agencies. Based on this reasonably available
information, EPA understands that the use of PCE in dry cleaning is
currently declining and that very few PCE machines are being produced
or sold in the U.S. market (Ref. 33). As described more fully in the
Economic Analysis (Ref. 3), EPA assumes dry cleaning machines are
retired 15 to 25 years after the manufactured date. Therefore, EPA
assumes most dry cleaning machines manufactured and installed before
2005, such as for 3rd generation machines, would be beyond their
projected useful life by the proposed phaseout dates outlined in this
Unit. A 3-year phaseout of the use of PCE in 3rd generation dry
cleaning machines takes into consideration the age of existing 3rd
generation dry cleaning machines as well as public comments submitted
on the proposed amendments to the PCE Dry Cleaning NESHAP (December 27,
2021, 86 FR 73207) recommending a 3- to 5-year compliance timeframe at
minimum to account for supply issues related to those machines. A 10-
year phaseout of the use of PCE in dry cleaning and spot cleaning takes
into account that, while the average projected useful lifespan of dry
cleaning machines is 15 to 25 years, the purchase of new PCE dry
cleaning machines has been in decline. As described more fully in the
Economic Analysis, EPA estimates that 6,000 dry cleaners still use PCE
and estimates that about 60 machines are expected to still be in use at
the end of the 10-year phaseout period given the declining trend of use
and age of machines. EPA believes that the proposed 6-month and 3-year
compliance dates for the start of the phaseout, and the proposed 10-
year compliance date for full implementation of the phaseout, are
consistent with requirements in TSCA section 6(d)(1)(C) and (D),
respectively, to specify mandatory compliance dates for the start of
phaseout requirements that are as soon as practicable but not later
than 5 years after the date of promulgation of the rule, and to specify
mandatory compliance dates for full implementation of phaseout
requirements that are as soon as practicable. EPA also believes that
these compliance dates provide for a reasonable transition period,
consistent with TSCA section 6(d)(1)(E). EPA has no reasonably
available information indicating that the proposed compliance dates are
not practicable for the activities that would be prohibited. However,
EPA requests comment on the amount of time needed, for example, for dry
cleaners to transition to an alternative process or solvent. EPA also
requests comment regarding the number of entities that could
potentially close as well as associated costs with a 10-year phaseout
of PCE for use in dry cleaning as identified in this unit. EPA may
finalize significantly shorter or longer compliance timeframes based on
consideration of public comments.
d. De Minimis Level
To aid the regulated community with implementing the prohibitions,
and to account for de minimis levels of PCE as an impurity in products,
EPA is proposing that products containing PCE at concentrations less
than 0.1% by weight are not subject to the prohibitions described in
this unit. EPA has determined that the prohibitions are only necessary
for products containing PCE at levels equal to or greater than 0.1% by
weight in order to eliminate the unreasonable risk of injury resulting
from inhalation and dermal exposures from PCE-containing products
during occupational and consumer conditions of use. EPA's description
for how allowing for a concentration of PCE up to 0.1% would address
the unreasonable risk associated with PCE-containing products and
rationale for this regulatory approach are in Unit V.A. EPA requests
comment on allowing this de minimis level of PCE in products to account
for impurities.
2. Workplace Chemical Protection Program (WCPP)
a. Overview
As described in Unit III.B.3., under TSCA section 6(a), 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 (i.e.,
manufacturing, processing, industrial and commercial use, and disposal)
conditions of use. A WCPP for PCE would encompass the inhalation
exposure limit and action level, Direct Dermal Contact Control (DDCC)
requirements, and the associated implementation requirements described
in this unit to ensure that the chemical substance no longer presents
unreasonable risk. Under a WCPP, owners or operators would have some
flexibility, within the parameters outlined in this unit, regarding how
they prevent exceedances of the
[[Page 39672]]
identified EPA exposure limit thresholds or prevent direct dermal
contact. In the case of PCE, meeting the EPA exposure limits and
implementing the DDCC requirements for certain occupational conditions
of use would address unreasonable risk to potentially exposed persons
from inhalation and dermal exposure.
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 where PCE
is present and who may be exposed to PCE under the conditions of use
for which a WCPP would apply. EPA's intention is to require a
comprehensive WCPP that would address the unreasonable risk from PCE to
potentially exposed persons directly handling the chemical or in the
area where the chemical is being used.
Similarly, the 2020 risk evaluation for PCE did not distinguish
between employers, contractors, or other legal entities or businesses
that manufacture, process, distribute in commerce, use, or dispose of
PCE. 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 PCE 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 to help ensure that the threshold is not exceeded. With an
ECEL, regulated entities have some flexibility, within certain
parameters outlined in this unit, for preventing exceedances of the
identified exposure threshold. Therefore, EPA generally refers to the
ECEL and ancillary requirements as a non-prescriptive approach. In the
case of PCE, the exposure threshold identified by EPA for certain
occupational conditions of use would mitigate unreasonable risk from
inhalation exposure driven by those conditions of use for potentially
exposed persons.
DDCC requirements are process-based approaches to prevent direct
dermal contact with PCE and associated implementation requirements
described in this unit to ensure that the chemical substance no longer
presents unreasonable risk from dermal exposure. As with the ECEL, DDCC
requirements allow regulated entities some flexibility within certain
parameters outlined in this unit for preventing direct dermal contact
with PCE. In the case of PCE, EPA has preliminarily determined that
preventing direct dermal contact through DDCC requirements for certain
conditions of use would mitigate unreasonable risk from dermal exposure
driven by those conditions of use for potentially exposed persons.
This unit includes a summary of the proposed PCE WCPP, including a
description of the ECEL; 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;
and additional requirements proposed for recordkeeping, and worker
training, participation, and notification. This unit also describes
proposed DDCC requirements for PCE, including potential exposure
controls, which consider the hierarchy of controls; proposed PPE as it
relates to dermal protection; and additional requirements proposed for
recordkeeping. This unit also describes compliance timeframes for these
proposed requirements.
b. Existing Chemical Exposure Limit (ECEL)
i. ECEL and ECEL action level. To reduce exposures in the workplace
and address the unreasonable risk of injury to health resulting from
inhalation exposures to PCE identified under the occupational
conditions of use in the TSCA 2020 Risk Evaluation for PCE, EPA is
proposing an ECEL of 0.14 parts per million (ppm) (0.98 mg/m3) for
inhalation exposures to PCE as an 8-hour TWA. This ECEL is based on the
occupational chronic, non-cancer human equivalent concentration (HEC)
for neurotoxicity (Ref. 10). EPA has determined, as a matter of risk
management policy, that ensuring exposures remain at or below the ECEL
would eliminate the contribution to the unreasonable risk of injury to
health for PCE resulting from inhalation exposures in an occupational
setting. EPA is proposing to establish requirements to meet an ECEL as
part of the WCPP for:
<bullet> Manufacturing (domestic manufacturing);
<bullet> Manufacturing (import);
<bullet> Processing as a reactant/intermediate;
<bullet> Processing into formulation, mixture, or reaction product
in cleaning and degreasing products;
<bullet> Processing into formulation, mixture, or reaction products
in paint and coating products;
<bullet> Processing into formulation, mixture, or reaction products
in adhesive and sealant products;
<bullet> Processing by repackaging;
<bullet> Industrial and commercial use as solvent for open-top
batch vapor degreasing;
<bullet> Industrial and commercial use as solvent for closed-loop
batch vapor degreasing;
<bullet> Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
<bullet> Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
<bullet> Industrial and commercial use in maskant for chemical
milling;
<bullet> Industrial and commercial use in solvent-based adhesives
and sealants; and
<bullet> Industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing.
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 address the unreasonable risk resulting from
inhalation exposures and the rationale for this regulatory approach are
outlined in Units III.B.3. and V.A.
If ambient exposures are kept at or below the 8-hour ECEL of 0.14
ppm, EPA expects that a potentially exposed person in the workplace
would be protected against non-cancer effects resulting from
occupational exposures, as well as excess risk of cancer (Ref. 10).
EPA is also proposing to establish an ECEL action level of 0.07 ppm
as an 8-hour TWA for PCE. Air concentrations at or above the action
level would trigger more frequent periodic monitoring of exposures to
PCE, as described in this unit. EPA is proposing to adopt the action
level approach in implementing the TSCA ECEL, consistent with the
action level approach utilized 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. 42). 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
[[Page 39673]]
PCE 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.
In summary, EPA is proposing that each owner or operator of a
workplace subject to the ECEL must ensure that no person is exposed to
airborne concentration of PCE in excess of 0.14 ppm (0.98 mg/m3) as an
8-hour TWA (ECEL), with an action level identified as 0.07 ppm (0.47
mg/m3) (ECEL action level). For conditions of use for which the
requirements to meet an ECEL are being proposed, EPA expects that the
regulated community can detect the ECEL and ECEL action level as they
are above the threshold of PCE air sampling analytical methods that are
widely available in commerce, currently in use, and approved by OSHA
and NIOSH, which can range from <=0.5 parts per billion (ppb) to 9 ppm
(Ref. 10). The Agency has also identified personal breathing zone air
sampling devices with a minimum limit of quantitation and level of
detection below the ECEL action level (Ref. 43). EPA is requesting
comment on issues around the viability of current analytical methods
and detection limits for occupational perchloroethylene sampling and/or
monitoring methods. EPA's methodology and inputs for the ECEL value are
directly derived from the peer reviewed analysis in the December 2020
Risk Evaluation, which was also subject to public comment. As with all
aspects of this rulemaking, the public is welcome to comment on the
methodology for the ECEL value.
EPA expects that many workplaces already have stringent controls in
place that reduce exposures to PCE; for some workplaces, EPA
understands that these existing controls may already reduce PCE air
concentration levels to near or below the ECEL. As discussed further in
Unit V.A.1., for some conditions of use for which EPA is proposing the
ECEL, data were submitted during the risk evaluation that indicate
inhalation exposures may already be near or below the ECEL for some
facilities, indicating that such facilities may already be in
compliance with the proposed ECEL. As noted previously in this unit,
EPA expects that, if inhalation exposures for affected occupational
conditions of use are kept at or below the ECEL, potentially exposed
persons reasonably likely to be exposed in the workplace would be
protected from the unreasonable risk. EPA is also proposing to require
owners or operators to comply with additional requirements under the
WCPP that would be needed to ensure successful implementation of the
ECEL.
ii. Monitoring requirements. Overview. Monitoring requirements are
a key component of implementing EPA's proposed WCPP. Initial monitoring
for PCE is critical for establishing a baseline of exposure for
potentially exposed persons; similarly, periodic exposure monitoring
assures continued compliance so that potentially exposed persons in the
workplace are not exposed to levels that would result in an
unreasonable risk of injury. 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 listed
earlier in this unit is occurring would be required to perform initial
exposure monitoring to determine the extent of exposure of potentially
exposed persons to PCE. 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
determine 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 PCE within 6 months
after the date of publication of the final rule in the Federal Register
or within 30 days of introduction of PCE into the workplace, whichever
is later. Where PCE 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. 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 PCE 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 PCE, 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 sampling 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 satisfies all other requirements of this section, including
the requirement that the data represents the highest PCE 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.
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:
<bullet> If all samples taken during the initial exposure
monitoring reveal a concentration below the ECEL action level (<0.07
ppm 8-hour TWA), the owner or operator must repeat the periodic
exposure monitoring at least once every five years.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA), the owner
or operator
[[Page 39674]]
must repeat the periodic exposure monitoring within 3 months of the
most recent exposure monitoring.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (>=0.07 ppm 8-
hour TWA) but at or below the ECEL (<=0.14 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within 6
months of the most recent exposure monitoring.
<bullet> 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 (<0.07
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, use, or dispose of PCE 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 PCE 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
IV.A.2. for which the WCPP is proposed.
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.
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. required at least once every
(<0.07 ppm 8-hour TWA)................. five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within 3 months of
above the ECEL (>0.14 ppm 8-hour TWA). the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within 6 months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.07 ppm 8-hour monitoring.
TWA, <=0.14 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 exposure is monitoring.
below the ECEL action level (<0.07 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic monitoring
would be required but does not event. However, documentation
manufacture, process, use, or dispose of cessation of use of PCE is
of PCE in that condition of use over required and periodic
the entirety of time since the last monitoring would be required
required monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
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 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.
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 PCE. Also, EPA is proposing
to require use of appropriate sampling and analytical methods used to
determine PCE 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 level 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.
[[Page 39675]]
(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.
(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. 8). EPA is proposing to
require owners or operators to reduce inhalation exposures below the
ECEL in accordance with the hierarchy of controls. EPA expects that,
for conditions of use for which EPA is proposing a WCPP, compliance at
most workplaces would be part of an existing industrial hygiene
program. Workplaces that cannot feasibly eliminate the source of PCE
emissions or replace PCE with a substitute would have to use
engineering and/or administrative controls to implement process changes
to reduce exposures to the extent feasible, following the hierarchy of
controls (Ref. 8). If an owner or operator chooses to replace PCE with
a substitute, EPA recommends that they carefully review the available
hazard and exposure information on the potential substitutes to avoid a
substitute chemical that might later be found to present unreasonable
risks or be subject to regulation (sometimes referred to as a
``regrettable substitution'').
If an effort to identify and implement feasible exposure controls
such as elimination, substitution, engineering controls, and
administrative controls are not 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 PCE
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 PCE by inhalation above the ECEL with respirators
sufficient to ensure that their exposures do not exceed the ECEL, as
described in this unit. 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.
iv. Regulated area. Based on the exposure monitoring, EPA is
proposing to require that owners or operators of workplaces subject to
a WCPP demarcate any area where airborne concentrations of PCE exceed
or are reasonably expected to exceed the ECEL. Regulated areas would be
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 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)).
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 accessible to all persons whose
exposure is represented by the monitoring, 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, any corresponding required
respiratory protection, if applicable, the quantity, location, manner
of PCE use and identified releases of PCE that could result in exposure
to PCE, and whether the airborne concentration of PCE exceeds the ECEL
limit. 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, and 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. Direct Dermal Contact Control Requirements
i. Direct dermal contact. DDCC requirements are a process-based set
of provisions to address unreasonable risk driven by dermal exposure by
preventing direct dermal contact in the workplace. In order to address
the unreasonable risk driven by dermal exposure to PCE, DDCC
requirements would include controls to separate, distance, physically
remove, or isolate all person(s) from direct handling of PCE or from
skin contact with surfaces that may be contaminated with PCE (i.e.,
equipment or materials on which PCE may be present) under routine
conditions in the workplace (hereafter referred to as direct dermal
contact). For purposes of DDCC requirements, direct dermal contact with
PCE does not include vapor exposures through the skin, although EPA
recommends and encourages owners and operators to implement control
measures to prevent or reduce dermal exposures to airborne PCE vapors.
The 2020 Risk Evaluation for PCE identified that unreasonable risk to
workers is also driven by the dermal exposure, specifically from direct
skin contact with PCE; risk exceeding the benchmark was identified even
when considering use of chemically resistant gloves in most commercial
and
[[Page 39676]]
industrial conditions of use. EPA's description for how the
requirements related to DDCC would address the unreasonable risk
resulting from dermal exposures and the rationale for this regulatory
approach is outlined in Units III.B.3. and V.A.
Similar to the ECEL, under DDCC requirements, EPA is proposing to
require owners and operators implement dermal exposure controls in
accordance with the hierarchy of controls. EPA also recommends and
encourages the use of pollution prevention as a means of controlling
exposures whenever practicable. In addition to the conditions of use
for which EPA is proposing to require a WCPP ECEL, EPA is also
proposing WCPP DDCC requirements for the following conditions of use:
recycling and disposal.
Within certain parameters outlined in this unit, DDCC requirements
are non-prescriptive to allow more flexibility to owners and operators
to choose their controls to prevent direct dermal contact when compared
with prescriptive requirements for specific controls. Each owner or
operator of a workplace engaging in a condition of use for which DDCC
requirements are proposed would be responsible for compliance with the
DDCC requirements and recordkeeping.
As discussed briefly in Unit IV.A.1. and further in Unit V.A.1.,
EPA expects that many workplaces already have stringent controls in
place that reduce dermal exposures to PCE; for some workplaces, EPA
understands that these existing controls may already prevent or reduce
direct dermal contact with PCE.
ii. Incorporation of the hierarchy of controls. As with the
requirements to meet an ECEL, EPA is proposing to require owners or
operators to implement DDCC requirements in accordance with the
hierarchy of controls and encourages the use of pollution prevention to
control exposures whenever practicable. EPA recognizes that some owners
or operators may have industrial hygiene practices already preventing
direct dermal contact with PCE in the workplace. For workplaces that
cannot feasibly eliminate the source of PCE dermal exposure or replace
PCE with a substitute, workplaces would have to use engineering and/or
administrative controls to implement process changes to prevent direct
dermal contact with PCE to the extent feasible. If an owner or operator
chooses to replace PCE 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 such as
elimination, substitution, engineering controls and administrative
controls is not sufficient to prevent direct dermal contact with PCE
for potentially exposed persons in the workplace, EPA proposes to
require each owner and operator to reduce potential for direct dermal
contact with PCE in the workplace by these controls and to supplement
these controls using PPE.
Examples of engineering controls that may prevent or reduce the
potential for direct dermal contact include automation, physical
barriers between contaminated and clean work areas, enclosed transfer
liquid lines (with purging mechanisms in place (e.g., nitrogen,
aqueous) for operations such as product changes or cleaning), and
design of tools (e.g., a closed-loop container system providing
contact-free connection for unloading fresh and collecting spent
solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples
of administrative controls that may prevent or reduce the potential for
direct dermal contact include adjusting work practices (i.e.,
implementing policies and procedures) such as providing safe working
distances from areas where direct handling of PCE may occur.
EPA requests comment on available methods to measure the
effectiveness of engineering and administrative controls in preventing
or reducing the potential for direct dermal contact to PCE. EPA is also
requesting comment on available monitoring methods, such as charcoal
patch testing, as feasible or effective methods to measure potential
direct dermal contact with PCE.
EPA proposes to require that owners and operators document their
implementation efforts and compliance with DDCC requirements in an
exposure control plan or through any existing documentation of the
facility's ``Safety and Health Program'' that may already be developed
as part of meeting OSHA requirements or other safety and health
standards (Ref. 44), as described in Unit IV.A.2.e.
d. 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 and/or prevent direct dermal contact
with PCE 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 PCE. 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
[[Page 39677]]
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 PCE 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 PCE
exposures exceed or can reasonably be expected to exceed the ECEL.
Given the risks associated with PCE 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. EPA believes that 3
months should be sufficient for this purpose. 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 PCE, 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 (0.14 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. While this unit includes respirator
selection requirements for respirators of assigned protection factors
(APFs) of 1,000 or greater, EPA does not anticipate that respirators
beyond APF 25 will be widely or regularly used to address unreasonable
risk, particularly when other controls are put in place.
<bullet> If the measured exposure concentration is at or below 0.14
ppm: no respiratory protection is required.
<bullet> If the measured exposure concentration is above 0.14 ppm
and less than or equal to 0.7 ppm (5 times ECEL): Any NIOSH-certified
air-purifying quarter mask respirator (APF 5).
<bullet> If the measured exposure concentration is above 0.7 ppm
and less than or equal to 1.4 ppm (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).
<bullet> If the measured exposure concentration is above 1.4 ppm
and less than or equal to 3.5 ppm (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).
<bullet> If the measured exposure concentration is above 3.5 ppm
and less than or equal to 7.0 ppm (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 facepiece and a
NIOSH-approved organic vapor cartridge (APF 50).
<bullet> If the measured exposure concentration is above 7.0 ppm
and less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH-
certified supplied air respirator equipped with a half mask or full
facepiece and operated in a pressure demand or other positive pressure
mode (APF 1,000).
<bullet> If the measured exposure concentration is greater than 140
ppm (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. Where elimination, substitution, engineering
controls, and administrative controls are not feasible or sufficient to
fully prevent direct dermal contact with PCE, EPA is proposing to
require that appropriate dermal PPE be provided by owners and operators
to, and be worn by, persons potentially exposed to direct dermal
contact with PCE. To accomplish this, EPA is proposing owners and
operators follow the dermal PPE requirements for PPE selection laid out
in this unit.
Required Dermal Protection. In choosing appropriate dermal PPE,
owners and operators would be required to select gloves, clothing, and
protective gear (which covers any exposed dermal area of arms, legs,
torso, and face) based on specifications from the manufacturer or
supplier that demonstrate an impervious barrier to PCE during expected
durations of use and normal conditions of exposure within the
workplace, accounting for potential chemical permeation or breakthrough
[[Page 39678]]
times. In alignment with the OSHA Hand Protection PPE Standard (29 CFR
1910.138), owners and operators would be required to select dermal PPE
based on an evaluation of the performance characteristics of the PPE
relative to the task(s) to be performed, conditions present, and the
duration of use. Further information related to choosing appropriate
PPE can be found in the summary of suitable gloves for PCE memo (Ref.
45).
For example, owners and operators can select gloves that have been
tested in accordance with the American Society for Testing and
Materials (ASTM) F739 ``Standard Test Method for Permeation of Liquids
and Gases through Protective Clothing Materials under Conditions of
Continuous Contact.'' EPA is proposing that PPE be provided for use for
a time period only to the extent and no longer than the time period for
which testing has demonstrated that the PPE will be impermeable during
expected durations of use and conditions of exposure. EPA is proposing
to require that owners and operators also consider other factors when
selecting appropriate PPE, including effectiveness of glove type when
preventing exposures from PCE alone and in likely combination with
other chemical substances used in the work area or when used with glove
liners, permeation, degree of dexterity required to perform task, and
temperature, as identified in the Hand Protection section of OSHA's
Personal Protective Equipment Guidance (Ref. 46).
EPA is proposing that owners and operators would be required to
establish, either through manufacturer or supplier-provided
documentation or individually prepared 3rd party testing that the
selected PPE will be impervious for the expected duration and
conditions of exposure, such as using the format specified in ASTM
F1194-99(2010) ``Standard Guide for Documenting the Results of Chemical
Permeation Testing of Materials Used in Protective Clothing
Materials,'' reporting cumulative permeation rate as a function of
time, or equivalent manufacturer- or supplier- provided testing. Owners
and operators would also be required to consider likely combinations of
chemical substances to which the clothing may be exposed in the work
area when selecting the appropriate PPE such that the PPE will prevent
direct dermal contact to PCE. EPA is proposing that PPE must be
immediately provided and replaced if any person is dermally exposed to
PCE longer than the breakthrough time period for which testing has
demonstrated that the PPE will be impermeable or if there is a chemical
permeation or breakage of the PPE.
Additionally, EPA is proposing to require that owners and operators
subject to this rule comply with provisions of 29 CFR 1910.133(b) for
requirements on selection and use of eye and face protection. EPA is
soliciting comments on the requirements proposed for appropriate PPE
selection, the effectiveness of PPE in preventing direct dermal contact
with PCE in the workplace, and general absorption and permeation
effects to PPE from direct dermal exposure. In addition, EPA
understands that some workplaces rinse and reuse PPE after minimal use
and is therefore soliciting comments on the impact on effectiveness of
rinsing and reusing certain types of PPE, either gloves or protective
clothing and gear. EPA also requests comment on the degree to which
additional guidance related to use of PPE might be appropriate.
EPA is also proposing that owners and operators retain records of
dermal PPE used and 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 any dermal PPE program, as applicable,
including: (A) The name, workplace address, work shift, job
classification, and work area of each person reasonably likely to
directly handle PCE or handle equipment or materials on which PCE may
present and the type of PPE selected to be worn by each of these
persons; (B) The basis for specific PPE selection (e.g., demonstration
based on permeation testing or manufacturer specifications that each
item of PPE selected provides an impervious barrier to prevent exposure
during expected duration and conditions of exposure, including the
likely combinations of chemical substances to which the PPE may be
exposed in the work area); (C) Appropriately sized PPE and training on
proper application, wear, and removal of PPE, and proper care/disposal
of PPE; (D) Occurrence and duration of any direct dermal contact with
PCE that occurs during any
[…truncated; see source link]Indexed from Federal Register on June 16, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.