[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 [www.gpo.gov]
[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 https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets/.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: 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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of 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:
Crude Petroleum Extraction (NAICS code 211120).
Support Activities for Oil and Gas Operations (NAICS code
213112).
Nonwoven Fabric Mills (NAICS code 313230).
Wood Window and Door Manufacturing (NAICS code 321911).
Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220).
Commercial Screen Printing (NAICS code 323113).
Petroleum Refineries (NAICS code 324110).
Petroleum Lubricating Oil and Grease Manufacturing (NAICS
code 324191).
Petrochemical Manufacturing (NAICS code 325110).
Industrial Gas Manufacturing (NAICS code 325120).
Other Basic Inorganic Chemical Manufacturing (NAICS code
325180).
All Other Basic Organic Chemical Manufacturing (NAICS code
325199).
Plastics Material and Resin Manufacturing (NAICS code
325211).
Synthetic Rubber Manufacturing (NAICS code 325212).
Paint and Coating Manufacturing (NAICS code 325510).
Adhesive Manufacturing (NAICS code 325520).
Soap and Other Detergent Manufacturing (NAICS code
325611).
Polish and Other Sanitation Good Manufacturing (NAICS code
325612).
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998).
Unlaminated Plastics Film and Sheet (except Packaging)
Manufacturing (NAICS code 326113).
All Other Plastics Product Manufacturing (NAICS code
326199).
Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220).
Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291).
All Other Rubber Product Manufacturing (NAICS code
326299).
[[Page 39653]]
Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110).
Glass Container Manufacturing (NAICS code 327213).
Cement Manufacturing (NAICS code 327310).
Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492).
Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119).
Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215).
Saw Blade and Handtool Manufacturing (NAICS code 332216).
Other Fabricated Wire Product Manufacturing (NAICS code
332618).
Metal Heat Treating (NAICS code 332811).
Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812).
Electroplating, Plating, Polishing, Anodizing, and
Coloring (NAICS code 332813).
Industrial Valve Manufacturing (NAICS code 332911).
Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912).
Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913).
Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919).
Ball and Roller Bearing Manufacturing (NAICS code 332991).
Small Arms Ammunition Manufacturing (NAICS code 332992).
Ammunition (except Small Arms) Manufacturing (NAICS code
332993).
Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994).
Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996).
All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999).
Other Industrial Machinery Manufacturing (NAICS code
333249).
Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415).
Machine Tool Manufacturing (NAICS code 333517).
Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914).
Welding and Soldering Equipment Manufacturing (NAICS code
333992).
Packaging Machinery Manufacturing (NAICS code 333993).
Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994).
Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995).
Fluid Power Pump and Motor Manufacturing (NAICS code
333996).
All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999).
Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513).
Analytical Laboratory Instrument Manufacturing (NAICS code
334516).
Motor Vehicle Body Manufacturing (NAICS code 336211).
Travel Trailer and Camper Manufacturing (NAICS code
336214).
Other Motor Vehicle Parts Manufacturing (NAICS code
336390).
Aircraft Manufacturing (NAICS code 336411).
Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412).
Other Aircraft Parts and Auxiliary Equipment Manufacturing
(NAICS code 336413).
Guided Missile and Space Vehicle Manufacturing (NAICS code
336414).
Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415).
Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419).
Ship Building and Repairing (NAICS code 336611).
Surgical and Medical Instrument Manufacturing (NAICS code
339112).
Jewelry and Silverware Manufacturing (NAICS code 339910).
Sporting and Athletic Goods Manufacturing (NAICS code
339920).
Doll, Toy, and Game Manufacturing (NAICS code 339930).
Office Supplies (except Paper) Manufacturing (NAICS code
339940).
Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991).
Musical Instrument Manufacturing (NAICS code 339992).
Fastener, Button, Needle, and Pin Manufacturing (NAICS
code 339993).
Broom, Brush, and Mop Manufacturing (NAICS code 339994).
Burial Casket Manufacturing (NAICS code 339995).
All Other Miscellaneous Manufacturing (NAICS code 339999).
Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS code 423120).
Home Furnishing Merchant Wholesalers (NAICS code 423220).
Industrial Supplies Merchant Wholesalers (NAICS code
423840).
Service Establishment Equipment and Supplies Merchant
Wholesalers (NAICS code 423850).
Other Miscellaneous Durable Goods Merchant Wholesalers
(NAICS code 423990).
Grain and Field Bean Merchant Wholesalers (NAICS code
424510).
Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690).
Petroleum Bulk Stations and Terminals (NAICS code 424710).
Petroleum and Petroleum Products Merchant Wholesalers
(except Bulk Stations and Terminals) (NAICS code 424720).
New Car Dealers (NAICS code 441110).
Used Car Dealers (NAICS code 441120).
Other Gasoline Stations (NAICS code 447190).
Sporting Goods Stores (NAICS code 451110).
All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS code 453998).
Scheduled Passenger Air Transportation (NAICS code
481111).
Scheduled Freight Air Transportation (NAICS code 481112).
Pipeline Transportation of Natural Gas (NAICS code
486210).
Teleproduction and Other Postproduction Services (NAICS
code 512191).
Other Motion Picture and Video Industries (NAICS code
512199).
Miscellaneous Intermediation (NAICS code 523910).
Other Financial Vehicles (NAICS code 525990).
Lessors of Other Real Estate Property (NAICS code 531190).
Offices of Real Estate Agents and Brokers (NAICS code
531210).
Testing Laboratories (NAICS code 541380).
Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715).
Marketing Research and Public Opinion Polling (NAICS code
541910).
All Other Professional, Scientific, and Technical Services
(NAICS code 541990).
Offices of Other Holding Companies (NAICS code 551112).
Hazardous Waste Treatment and Disposal (NAICS code
562211).
Solid Waste Landfill (NAICS code 562212).
Solid Waste Combustors and Incinerators (NAICS code
562213).
Other Nonhazardous Waste Treatment and Disposal (NAICS
code 562219).
Remediation Services (NAICS code 562910).
Materials Recovery Facilities (NAICS code 562920).
[[Page 39654]]
All Other Miscellaneous Waste Management Services (NAICS
code 562998).
General Automotive Repair (NAICS code 811111).
Automotive Exhaust System Repair (NAICS code 811112).
Automotive Transmission Repair (NAICS code 811113).
Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118).
Automotive Body, Paint, and Interior Repair and
Maintenance (NAICS code 811121).
Automotive Glass Replacement Shops (NAICS code 811122).
Automotive Oil Change and Lubrication Shops (NAICS code
811191).
All Other Automotive Repair and Maintenance (NAICS code
811198).
Consumer Electronics Repair and Maintenance (NAICS code
811211).
Computer and Office Machine Repair and Maintenance (NAICS
code 811212).
Communication Equipment Repair and Maintenance (NAICS code
811213).
Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219).
Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310).
Home and Garden Equipment Repair and Maintenance (NAICS
code 811411).
Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490).
Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320).
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.
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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
[[Page 39660]]
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 https://www.regulations.gov.
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
[[Page 39661]]
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.
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (TSCA section
6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records, or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk
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,
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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
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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
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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:
As a processing aid in pesticide, fertilizer and other
agricultural chemical manufacturing;
In specialty DOD uses (oil analysis and water pipe
repair);
In solvent-based paints and coatings;
As solvent for aerosol spray degreaser/cleaner;
As solvent for cold cleaning;
In other textile processing;
In wood furniture manufacturing;
As a solvent for aerosol lubricants;
In wipe cleaning;
In other spot cleaning and spot removers, including carpet
cleaning;
In automotive care products (e.g., engine degreaser and
brake cleaner);
In non-aerosol cleaner;
In metal (e.g., stainless steel) and stone polishes;
In foundry applications;
In welding;
For mold release;
As a solvent for penetrating lubricants and cutting tool
coolants;
For photographic film;
In inks and ink removal products (based on printing);
In inks and ink removal products (based on photocopying);
and
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:
In cleaners and degreasers (other);
In automotive care products (brake cleaner);
In automotive care products (parts cleaner);
In aerosol cleaner (vandalism mark and stain remover);
In non-aerosol cleaner (e.g., marble and stone polish);
In lubricants and greases (cutting fluid);
In lubricants and greases (lubricants and penetrating
oils);
In adhesives for arts and crafts (including industrial
adhesive, arts and crafts adhesive, gun ammunition sealant);
In adhesives for arts and crafts (livestock grooming
adhesive);
In adhesives for arts and crafts (column adhesive, caulk
and sealant);
In solvent-based paints and coatings (outdoor water shield
(liquid));
In solvent-based paints and coatings (coatings and primers
(aerosol));
In solvent-based paints and coatings (rust primer and
sealant (liquid));
In solvent-based paints and coatings (metallic overglaze);
In metal (e.g., stainless steel) and stone polishes;
In inks and ink removal products;
In welding; and
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:
Industrial and commercial use in dry cleaning and spot
cleaning post-2006 dry cleaning;
Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th generation only dry cleaning; and
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:
Manufacturing (domestic manufacturing);
Manufacturing (import);
Processing as a reactant/intermediate;
Processing into formulation, mixture, or reaction product
in cleaning and degreasing products;
Processing into formulation, mixture, or reaction products
in paint and coating products;
Processing into formulation, mixture, or reaction products
in adhesive and sealant products;
Processing by repackaging;
Industrial and commercial use as solvent for open-top
batch vapor degreasing;
Industrial and commercial use as solvent for closed-loop
batch vapor degreasing;
Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
Industrial and commercial use in maskant for chemical
milling;
Industrial and commercial use in solvent-based adhesives
and sealants; and
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:
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.
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.
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.
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.
If the measured exposure concentration is at or below 0.14
ppm: no respiratory protection is required.
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).
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).
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).
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).
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).
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 activity or malfunction at the workplace
that causes direct dermal exposures to occur and/or glove breakthrough,
and corrective actions to be taken during and immediately following
that activity or malfunction to prevent direct dermal contact to PCE;
and (E) Training in accordance with 29 CFR 1910.132(f), including any
re-training. EPA may require more, less, or different documentation in
the final rule based on consideration of public comments.
e. General WCPP Requirements
i. Exposure Control Plan. EPA proposes to require that owners and
operators document their exposure control strategy and implementation
in an exposure control plan or through adding EPA-required information
to any existing documentation of the facility's safety and health
program developed as part of meeting OSHA requirements or other safety
and health standards. EPA proposes to require that each owner or
operator document in the exposure control plan the following:
(A) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of PCE, substitution of
PCE, engineering controls, and administrative controls to reduce
exposures in the workplace to either at or below the ECEL or to the
lowest level achievable and to prevent or reduce direct dermal contact
with PCE in the workplace;
(B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(D) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(E) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL;
(F) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(G) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or any direct dermal contact with PCE and subsequent
corrective actions taken during start-up, shutdown, or malfunctions to
mitigate exposures to PCE; and
(H) Availability of the exposure control plan and associated
records for potentially exposed persons.
ii. Workplace Information and Training. EPA is also proposing to
require implementation of a training program in alignment with the OSHA
Hazard Communication Standard (29 CFR 1910.1200) and the OSHA General
Industry Standard for Methylene
[[Page 39679]]
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with PCE
exposure, EPA is proposing to require that owners or operators of
workplaces subject to the WCPP institute a training and information
program for potentially exposed persons and assure their participation
in the training and information program.
As part of the training and information program, the owner or
operator would be required to provide information and comprehensive
training in an understandable manner (i.e., plain language) and in
multiple language as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons prior to or
at the time of initial assignment to a job involving potential exposure
to PCE. In alignment with the OSHA Hazard Communication Standard,
owners and operators would be required to provide information and
training to all potentially exposed persons that includes (A) the
requirements of the PCE WCPP and how to access or obtain a copy of the
requirements of the WCPP; (B) the quantity, location, manner of use,
release, and storage of PCE and the specific operations in the
workplace that could result in PCE exposure; (C) principles of safe use
and handling of PCE in the workplace, including specific measures the
owner or operator has implemented to reduce inhalation exposures to at
or below the ECEL or prevent direct dermal contact with PCE, such as
work practices and PPE used; (D) the methods and observations that may
be used to detect the presence or release of PCE in the workplace (such
as monitoring conducted by the owner or operator, continuous monitoring
devices, visual appearance or odor of PCE when being released, etc.);
and (E) the health hazards associated with exposure with PCE.
In addition to providing training at the time of initial assignment
to a job involving potential exposure to PCE, and in alignment with the
OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners
and operators subject to the PCE WCPP would be required to re-train
each potentially exposed person annually to ensure they understand the
principles of safe use and handling of PCE in the workplace. Owners and
operators would also need to update the training as necessary whenever
there are changes in the workplace, such as new tasks or modifications
of tasks; in particular, whenever there are changes in the workplace
that increase exposure to PCE or where potentially exposed persons'
exposure to PCE can reasonably be expected to exceed the action level
or increase the potential for direct dermal contact with PCE. To
support compliance, EPA is proposing that each owner or operator of a
workplace subject to the WCPP would be required to provide to the EPA,
upon request, all available materials related to workplace information
and training.
iii. Workplace Participation. EPA encourages owners or operators to
consult with persons that have potential for exposure on the
development and implementation of exposure control plans and PPE/
respirator programs. EPA is proposing to require owners or operators to
provide potentially exposed persons or their designated representatives
regular access to the exposure control plans, exposure monitoring
records, and PPE program implementation and documentation. To ensure
compliance in workplace participation, EPA is proposing that the owner
or operator document the notice to and ability of any potentially
exposed person that may reasonably be affected by PCE inhalation
exposure or direct dermal contact with PCE to readily access the
exposure control plans, facility exposure monitoring records, PPE
program implementation, or any other information relevant to PCE
exposure in the workplace. EPA is requesting comment on how owners and
operators can engage with potentially exposed persons on the
development and implementation of an exposure control plan and PPE
program.
iv. Recordkeeping. To support and demonstrate compliance, EPA is
proposing that each owner or operator of a workplace subject to WCPP
retain compliance records for five years. EPA is proposing to require
records to include:
(A) the exposure control plan;
(B) PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
(C) information and training provided to each person prior to or at
the time of initial assignment and any re-training.
In addition, EPA is proposing that owners and operators subject to
the WCPP ECEL requirements maintain records to include:
(D) The exposure monitoring records;
(E) Notification of exposure monitoring results; and
(F) To the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the requirements of this section.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA for examination and copying in accordance with EPA
requirements. All records required to be maintained by this unit could
be kept in the most administratively convenient form (electronic or
paper).
v. Compliance timeframes. EPA is proposing to require each owner or
operator of a workplace subject to an ECEL conduct initial baseline
monitoring according to the process outlined in this unit by 6 months
after date of publication of the final rule in the Federal Register or
within 30 days of introduction of PCE into the workplace if PCE use
commences at least 6 months after the date of publication. EPA is
proposing to require each owner or operator ensure that the airborne
concentration of PCE does not exceed the ECEL for all potentially
exposed persons within 9 months after the date of publication of the
final rule in the Federal Register, or beginning 4 months after
introduction of PCE into the workplace if PCE use commences at least 6
months after the date of publication. EPA is also proposing to require
owners and operators demarcate and maintain a regulated area wherever
exposures exceed or can reasonably be expected to exceed the ECEL
beginning 9 months after the date of publication of the final rule in
the Federal Register, or beginning 4 months after introduction of PCE
into the workplace if PCE use commences at least 6 months after the
date of publication. If applicable, EPA is also proposing that each
owner or operator must provide respiratory protection sufficient to
reduce inhalation exposures to below the ECEL to all potentially
exposed persons in the regulated area within 3 months after receipt of
the results of any exposure monitoring that indicates exposures
exceeding the ECEL or, if using monitoring data conducted within five
years prior to the effective date of this rule that satisfies all other
requirements of this section, within 9 months after the date of
publication of the final rule in the Federal Register. Regulated
entities should then proceed accordingly to implement an exposure
control plan within 12 months after date of publication of the final
rule in the Federal Register. EPA requests comment relative to the
ability of owners or operators to conduct initial monitoring within 6
months after date of publication of the final rule in the Federal
Register, and anticipated timelines for any procedural
[[Page 39680]]
adjustments needed to comply with the requirements outlined in this
unit, including establishment of a respiratory protection program and
development of an exposure control plan.
With regard to the compliance timeframe for those occupational
conditions of use which are subject to DDCC requirements, EPA is
proposing to require each owner and operator of a workplace subject to
DDCC establish the process outlined in this unit by 12 months after
publication of the final rule in the Federal Register. EPA requests
comment relative to the ability of owners or operators to implement
such processes within 12 months of publication of the final rule in the
Federal Register, and anticipated timelines for any procedural
adjustments needed to comply with the requirements outlined in this
unit. EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
3. Prescriptive Controls
a. Overview
In contrast to the proposed non-prescriptive requirements of the
ECEL and DDCC where regulated entities would have flexibility to select
controls in accordance with the hierarchy of controls to comply with
the parameters outlined in this unit, EPA may also find it appropriate
in certain circumstances to require specific prescriptive controls for
certain occupational conditions of use. In the 2020 Risk Evaluation for
PCE, EPA identified certain workplace controls that reduce exposures
from PCE adequate to address the unreasonable risk driven by inhalation
exposures from the industrial and commercial use of PCE in laboratory
chemicals. Therefore, EPA is proposing to require specific prescriptive
controls for the industrial and commercial use of PCE in laboratory
chemicals, as described in this unit. This unit describes proposed
requirements for a fume hood and dermal PPE for the industrial and
commercial use of PCE in laboratory chemicals, including additional
requirements proposed for recordkeeping. This unit also describes
compliance timeframes for these proposed requirements.
b. Workplace Requirements for Laboratory Use
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from dermal exposures to PCE
identified for the industrial and commercial use as a laboratory
chemical, EPA is proposing to require dermal PPE in combination with
comprehensive training for tasks particularly related to the use of PCE
in a laboratory setting as specified in this unit for each potentially
exposed person to direct dermal contact with PCE. Additionally, EPA is
proposing to require the use of fume hoods in workplaces engaged in the
laboratory chemical condition of use to codify the assumption of
existing good laboratory practices that EPA relied upon as a key basis
for its evaluation of risk from this condition of use (Ref. 1). Each
owner or operator of a workplace where the industrial and commercial
use of PCE as a laboratory chemical occurs would be responsible for
compliance with the requirements outlined in this unit. EPA's
description for how these requirements would address the unreasonable
risk and the rationale for this regulatory approach is outlined in Unit
III.B.3. and Unit V.A.
EPA is proposing to require dermal PPE, including impermeable
gloves and protective clothing, in combination with comprehensive
training for tasks where there is potential for direct dermal contact
with PCE (see Unit IV.A.2.d.). In selecting and providing appropriate
dermal PPE and providing PPE training, owners and operators would be
required to follow the PPE program and dermal protection requirements
laid out in Unit IV.A.2.d.ii. Unlike DDCC, this proposed provision
would not require owners and operators to use elimination,
substitution, engineering controls, and administrative controls, prior
to relying on PPE, as a means of controlling exposures in accordance
with the hierarchy of controls.
For laboratory fume hoods, EPA is proposing to require each owner
or operator of a workplace engaged in the laboratory chemical condition
of use to ensure fume hoods are in use and functioning properly to
minimize exposures to potentially exposed persons in the area where PCE
is used as a laboratory chemical. EPA suggests owners or operators
refer to OSHA's 29 CFR 1910.1450, appendix A National Research Council
Recommendations Concerning Chemical Hygiene in Laboratory, for
ventilation system characteristics and practices to minimize exposures
to workers in the area. As noted in these non-mandatory
recommendations, which are based on the National Research Council's
2011 edition of ``Prudent Practices in the Laboratory: Handling and
Management of Chemical Hazards,'' recommended practices for laboratory
chemical hoods include, but are not limited to, regularly inspecting
and maintaining the ventilation system, ensuring a negative pressure
differential between the amount of air exhausted from the laboratory
and the amount supplied to the laboratory to prevent uncontrolled
chemical vapors from leaving the laboratory, and preventing laboratory
air from recirculating back into the laboratory (Ref. 47). EPA requests
comment on whether it should incorporate in the rule best practices to
ensure proper and adequate performance of laboratory fume hoods, such
as those identified in OSHA's 29 CFR 1910.1450, Appendix A National
Research Council Recommendations Concerning Chemical Hygiene in
Laboratory.
To support and demonstrate compliance, EPA is proposing that each
owner or operator of a laboratory workplace subject to the requirements
of this unit retain compliance records for five years. EPA is proposing
to require records to include: (A) PPE program implementation and
documentation as outlined in this unit; and (B) Implementation of a
properly functioning fume hood using manufacturer's instructions for
installation, use, and maintenance of the fume hood, including
inspections, tests, development of maintenance procedures, the
establishment of criteria for acceptable test results, and
documentation of test and inspection results. Every five years, the
owner or operator would be required to update these records.
EPA is proposing to require that each owner or operator of a
workplace engaged in the industrial and commercial use of PCE as a
laboratory chemical ensure fume hoods are in use and functioning
properly and dermal PPE is provided to all potentially exposed persons
to direct dermal contact with PCE according to the process outlined in
this unit within 12 months after publication of the final rule. EPA
requests comment relative to the ability of owners or operators to
implement laboratory chemical fume hood and dermal PPE related
requirements within 12 months of publication of the final rule, and
anticipated timelines for any procedural adjustments needed to comply
with the requirements outlined in this unit. EPA may finalize
significantly shorter or longer compliance timeframes based on
consideration of public comments.
4. Other Requirements
a. Recordkeeping
In addition to the recordkeeping requirements for the WCPP and
prescriptive controls outlined in this unit, for conditions of use that
are not otherwise prohibited under this
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proposed regulation, EPA is also proposing that manufacturers,
processors, distributors, and commercial users maintain ordinary
business records, such as invoices and bills-of-lading, that
demonstrate compliance with the prohibitions, restrictions, and other
provisions of this proposed regulation; and to maintain such records
for a period of 5 years from the date the record is generated. EPA is
proposing that this requirement begin at the effective date of the rule
(60 days following publication of the final rule in the Federal
Register). Recordkeeping requirements would ensure that owners or
operators can demonstrate compliance with the regulations if necessary.
EPA may require more, less, or different documentation in the final
rule based on consideration of public comments.
b. Downstream Notification
For conditions of use that are not otherwise prohibited under this
proposed regulation, EPA is proposing that manufacturers (including
importers), processors, and distributors, excluding retailers, of PCE
and PCE-containing products provide downstream notification of the
prohibitions through the Safety Data Sheets (SDS) required by OSHA
under 29 CFR 1910.1200(g) by adding to sections 1(c) and 15 of the SDS
the following language:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be
distributed in commerce to retailers for any use. After [DATE 21
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], this chemical/product is and can only be distributed in
commerce or processed for the following purposes: Processing as a
reactant/intermediate; Processing into formulation, mixture or
reaction product in cleaning and vapor degreasing products;
Processing into formulation, mixture or reaction product in paint
and coating products; Processing into formulation, mixture or
reaction product in adhesive and sealant products; Processing by
repackaging; Recycling; Industrial and commercial use as solvent in
vapor degreasing; Industrial and commercial use in maskant for
chemical milling; Industrial and commercial use as a processing aid
in catalyst regeneration in petrochemical manufacturing; Industrial
and commercial use in laboratory chemicals; Industrial and
commercial use in solvent-based adhesives and sealants; Industrial
and commercial use in dry cleaning in 3rd generation machines until
[DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER]; Industrial and commercial use in dry cleaning and
related spot cleaning until [DATE 10 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER]; and Disposal.
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on PCE under TSCA as
well as provide information to commercial end users about allowable
uses of PCE.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA is proposing
a 2-month period for manufacturers and a 6-month period for processors
and distributers to implement the proposed SDS changes following
publication of the final rule.
EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
5. TSCA Section 6(g) Exemptions
Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if EPA makes one of three findings
required by the statute. TSCA section 6(g)(1)(A) permits such an
exemption if EPA finds that 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. TSCA section 6(g)(1)(B) permits such an exemption if EPA
finds that 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. Finally, TSCA
section 6(g)(1)(C) allows for an exemption if EPA finds that the
specific condition of use of the chemical substance or mixture, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety.
TSCA section 6(g)(2) requires EPA to analyze the need for the
exemption, and to make public the analysis and a statement on how the
analysis was taken into account when proposing an exemption under TSCA
section 6(g). Based on discussions with and information provided by the
National Aeronautics and Space Administration (NASA), EPA has analyzed
the need for an exemption for certain uses of PCE in an emergency in
the furtherance of NASA's mission and is proposing to grant it. This
unit presents the results of that analysis.
Pursuant to TSCA section 6(g)(3), if an exemption is finalized, EPA
may by rule later extend, modify, or eliminate the exemption, on the
basis of reasonably available information and after adequate public
justification, if EPA determines the exemption warrants a change. EPA
will initiate this rulemaking process at the request of any regulated
entity benefiting from such an exemption. The Agency is open to
engagement throughout the duration of any 6(g) exemption, and
emphasizes that to ensure continuity in the event of an extension or
modification, such a request should come at least 2 years prior to the
expiration of an exemption.
a. Analysis of the Need for TSCA Section 6(g)(1)(A) Exemption for
Certain NASA Uses in an Emergency for Which no Technically or
Economically Feasible Safer Alternative is Available
EPA considered a TSCA section 6(g) exemption for emergency use of
PCE in the furtherance of NASA's mission. For certain specific
conditions of use, EPA proposes that use of PCE by NASA and its
contractors in an emergency be exempt from the requirements of this
rule because it is a critical or essential use provided that (1) there
is an emergency; and (2) NASA selected PCE because there are no
technically and economically feasible safer alternatives available
during the emergency.
NASA operates on the leading edge of science seeking innovative
solutions to future problems where even small volumes of an otherwise
prohibited chemical substance could be vital to crew safety and mission
success. During interagency review, NASA expressed concerns that there
will likely be circumstances where a specific, EPA-prohibited condition
of use may be identified by NASA during an emergency as being needed in
order to avoid or reduce situations of harm or immediate danger to
human health, or the environment, or avoid imperiling NASA space
missions. In such cases, it is possible that no technically and
economically feasible safer alternative would be available that meets
the stringent technical performance requirements necessary to remedy
harm or avert danger to human health, the environment, or avoid
imperiling NASA space missions.
An emergency is a serious and sudden situation requiring immediate
action to remedy harm or avert danger to human health, the environment,
or to avoid imperiling NASA space missions. In NASA's case, there may
be instances where the emergency use of PCE for specific conditions of
use is critical or essential to remedying harm or averting danger to
human health, the environment, or avoiding imperiling NASA space
missions. Because of the
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immediate and unpredictable nature of emergencies described in this
unit and of the less forgiving environments NASA operates in that offer
little to no margin for error, it is likely that, at the time of
finalization of this proposal, alternatives to emergency PCE use may
not be available in a timely manner to avoid or reduce harm or
immediate danger (Ref. 48). In this way, these emergencies for
particular conditions of use meet the criteria for an exemption under
TSCA section 6(g)(1)(A), because the emergency use of PCE for listed
conditions of use is critical or essential and no technically and
economically feasible safer alternative will be available in a timely
manner, taking into consideration hazard and exposure.
In support of the TSCA section 6(g)(1)(A) emergency use exemption,
NASA submitted detailed criteria which they must use to screen,
qualify, and implement materials to be used in spacecraft equipment, as
well as historical case studies that outline the loss of life and loss
of assets in the discharge of previous missions. In one of several
examples detailed, the Apollo I command module fire that claimed the
lives of three American astronauts demonstrated the need for careful
testing and continuity of materials (Ref. 48). Moreover, due to NASA's
rigorous safety testing requirements under various environmental
conditions, technically and economically feasible safer alternatives
may not be readily available during emergencies and may require certain
conditions of use of PCE to alleviate the emergency.
In another example, NASA identified a scenario concerning a mission
to the International Space Station (ISS) whereby, during a launch
evolution, the countdown was paused immediately prior to launch (T-2
minutes). NASA engineers identified a clogged filter and supply line as
the primary issue, which required immediate attention (i.e., line
flushing and filter cleaning). In this type of emergency scenario, an
already approved chemical substance rated for space system applications
is necessary to immediately remedy the situation. Although PCE was not
used in this particular incident, if it were needed, in the future to
address such an emergency, then the proposed exemption would allow for
its lawful use--the countdown would resume and the launch would occur.
Conversely, without an exemption under the specific condition of use
(e.g., industrial and commercial use in wipe cleaning), NASA's use of
PCE would be otherwise prohibited, which would put NASA in an untenable
position of having to choose to either violate the law or place the
mission (and potentially the health and safety of its employees
involved in the mission) at risk.
The identification and qualification of compatible materials in the
context of aviation is iterative and involves expansive collaboration
between original equipment manufacturers, federal agencies, and
qualifying institutions. This is equally, if not more so, the case in
the context of human space flight operations undertaken by NASA (Ref.
48). NASA's mission architecture requirements often are developed many
years in advance of an actual launch occurring. As part of mission
planning, space systems are designed, full scale mock-ups are built,
and mission critical hardware is constructed using materials qualified
for spaceflight. Once NASA's mission architecture requirements are
developed, NASA may need to retain emergency access to PCE because its
alternatives may not have yet gone through NASA's rigorous
certification process before their use. Allowing NASA to retain
emergency use of PCE would reduce the chances that this rulemaking will
hinder future space missions for which mission architecture
infrastructure is being developed or is already built. While NASA
considers alternatives to the chemical substances it currently uses in
its space system designs, NASA has not yet identified technically and
economically feasible alternatives to proven chemistries in many
current applications. While EPA acknowledges that the use of PCE in
emergency situations may be necessary in the near term, it is also
EPA's understanding that NASA will continue its work to identify and
qualify alternatives to PCE. Thus, EPA is proposing an exemption
duration of 10 years.
b. Proposed Exemption for Certain Emergency Uses of PCE in the Context
of Human Space Flight
For the reasons discussed in this Unit, EPA is proposing a 10-year
exemption for emergency use of PCE in furtherance of NASA's mission for
the following specific conditions of use: Industrial and commercial use
as solvent for cold cleaning; Industrial and commercial use in wipe
cleaning. EPA is also proposing to include additional requirements as
part of the exemption, pursuant to TSCA section 6(g)(4), including
required notification and controls for exposure, to the extent
feasible: (1) NASA and its contractors must provide notice to the EPA
Administrator of each instance of emergency use within 15 days and; (2)
NASA and its contractors would have to comply with the WCPP described
in Unit IV.A.2 to the extent feasible.
EPA is proposing to require that NASA notify EPA within 15 days of
the emergency use. The notification would include a description of the
specific use of PCE in the context of one of the conditions of use for
which this exemption is being proposed, an explanation of why the use
described qualifies as an emergency, and an explanation with regard to
the lack of availability of technically and economically feasible
alternatives.
EPA expects NASA and its contractors have the ability to implement
a WCPP as described in Unit IV.A.2. for the identified uses in the
context of an emergency, to some extent even if not to the full extent
of WCPP implementation. Therefore, EPA is proposing to require that
during emergency use, NASA must comply with the WCPP to the extent
technically feasible in light of the particular emergency. Under the
proposed exemption, NASA and its contractors would still be subject to
the proposed general recordkeeping requirements discussed in Unit
IV.A.4.
EPA requests comment on this TSCA section 6(g) exemption for
continued emergency use of PCE in the furtherance of NASA's mission as
described in this unit, and whether any additional conditions of use
should be included, in particular for any uses qualified for space
flight for which no technically and economically feasible safer
alternative is available. Additionally, EPA requests comment on what
would constitute sufficient justification of an emergency.
B. Alternative Regulatory Actions
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA
must consider and publish a statement based on reasonably available
information with respect to the reasonably ascertainable economic
consequences of the rule, including consideration of the costs and
benefits and the cost effectiveness of the proposed regulatory action
and one or more primary alternative regulatory actions considered by
the Agency. This unit includes a description of the primary alternative
regulatory action and the second alternative regulatory action
considered by the Agency. An overview of the proposed regulatory action
and two alternative regulatory actions for each condition of use is in
Unit IV.C.
1. Primary Alternative Regulatory Action Considered
The primary alternative regulatory action described in this
document and
[[Page 39683]]
considered by EPA combines prohibitions, requirements for a WCPP, and
prescriptive controls to address the unreasonable risk from PCE driven
by the various conditions of use. While in some ways it is similar to
the proposed regulatory action, the primary alternative regulatory
action described in this document differs from the proposed regulatory
action by providing for a WCPP, including requirements to meet an ECEL
or DDCC, for some conditions of use that would be prohibited under the
proposed regulatory action. The primary alternative regulatory action
also considers prescriptive workplace controls where existing
engineering controls, administrative controls, and PPE may already
address the unreasonable risk for some conditions of use that would be
subject to a WCPP under the proposed regulatory action. The primary
alternative regulatory action additionally includes longer compliance
timeframes for prohibitions and implementation of WCPP and prescriptive
controls, as described in this unit. EPA requests comment on this
primary alternative regulatory action and whether any elements of this
primary alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. EPA is
requesting comment on whether to consider a regulatory alternative that
would subject more conditions of use to a WCPP, instead of prohibition,
than those currently contemplated in the primary alternative regulatory
action. EPA also requests monitoring data and detailed descriptions of
PCE involving activities for these conditions of use to determine
whether these additional conditions of use could comply with the WCPP
such that risks are no longer unreasonable. EPA also requests comment
on any advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
a. Prohibitions
The primary alternative regulatory action considered by EPA would
prohibit the manufacturing, processing, distribution in commerce, and
use for the following industrial and commercial uses, which EPA is also
proposing to prohibit as part of the proposed regulatory action:
industrial and commercial use as solvent for cold cleaning; industrial
and commercial use in other textile processing; industrial and
commercial use in wood furniture manufacturing; industrial and
commercial use as a solvent for aerosol lubricants; industrial and
commercial use in wipe cleaning; industrial and commercial use in other
spot cleaning and spot removers, including carpet cleaning; industrial
and commercial use in automotive care products (e.g., engine degreaser
and brake cleaner); industrial and commercial use in non-aerosol
cleaner; industrial and commercial use in metal (e.g., stainless steel)
and stone polishes; industrial and commercial use in foundry
applications; industrial and commercial use as a solvent for
penetrating lubricants and cutting tool coolants; industrial and
commercial use in welding; industrial and commercial use for mold
release; commercial use for photographic film; commercial use in inks
and ink removal products (based on printing); commercial use in inks
and ink removal products (based on photocopying); and commercial use in
metal mold cleaning, release and protectant products. Additionally, the
primary alternative regulatory action would prohibit the manufacture,
processing, and distribution of PCE for consumer use. As shown in Unit
IV.C., which presents an overview of the proposed regulatory action and
two alternative regulatory actions for each condition of use, the
primary alternative action described in this document would prohibit
fewer occupational conditions of use than the proposed regulatory
action.
Regarding compliance timeframes, the primary alternative regulatory
action would include longer timeframes for implementation of the
prohibitions than the proposed regulatory action. Under the primary
alternative action, the prohibitions would generally take effect 6
months later than in the proposed regulatory action. Under a compliance
timeframe that is 6 months longer than the proposed regulatory action,
the prohibitions for the manufacturing, processing, distribution in
commerce, and use of PCE for certain occupational conditions of use
described in this unit would take effect 18 months for manufacturers,
21 months for processers, 24 months for distributing to retailers, 27
months for all other distributors (including retailers), and 30 months
for industrial and commercial uses after the publication date of the
final rule. With regard to the compliance timeframe for the
manufacturing, processing, and distribution in commerce for consumer
use (other than consumer use of clothing and articles that have been
commercially dry cleaned with PCE), under the primary alternative
regulatory action, prohibitions described in this unit would take
effect in 18 months for manufacturers, 21 months for processors, 24
months for distributing to retailers, and 27 months for all other
distributors (including retailers) after the publication date of the
final rule.
Like the proposed action, the primary alternative regulatory action
would also phaseout the manufacturing, processing, distribution in
commerce, 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.
However, the timeframes for the phaseout differ between the proposed
action and the primary alternative action, described later in this
unit. As described in Unit IV.A.3., a prohibition on these conditions
of use would address the unreasonable risk driven by the following
uses: industrial and commercial use in dry cleaning and spot cleaning
post-2006 dry cleaning; industrial and commercial use in dry cleaning
and spot cleaning 4th/5th generation only dry cleaning; and consumer
use in dry cleaning solvent.
With regards to the prohibition of dry cleaning conditions of use,
under the primary alternative regulatory action, the following phaseout
timeline would take effect after the publication date of the final
rule: prohibition on the use of PCE in dry cleaning machines acquired
12 months after the publication date of the final rule; a prohibition
on the use of PCE in 3rd generation machines 5 years after the
publication date of the final rule; a prohibition on the use of PCE in
dry cleaning and spot cleaning 15 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 15
years after the publication date of the final rule.
b. Workplace Chemical Protection Program (WCPP)
The primary alternative regulatory action described in this
document would require a WCPP, including requirements to meet an ECEL
and DDCC, for the following conditions of use: industrial and
commercial use in laboratory chemicals; processing into formulation,
mixture, or reaction product in other chemical products and
preparations; industrial and commercial use as a processing aid in
pesticide, fertilizer and other agricultural chemical manufacturing;
industrial and commercial use in specialty DOD uses (oil analysis and
water pipe repair); industrial and commercial use in solvent-based
paints and coatings; and industrial and commercial use as
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solvent for aerosol spray degreaser/cleaner. As described in Unit V.A.,
uncertainties regarding (i) the feasibility of implementing workplace
safety control measures in open-systems or when worker activities
require manual application or removal of PCE or PCE-containing
products, (ii) availability of alternatives, or (iii) whether the use
is ongoing or phased out led EPA to propose that most of these
conditions of use be prohibited. EPA does not have sufficient
information to confidently conclude that these conditions of use can
meet requirements of a WCPP for PCE. Therefore, EPA requests comment on
the ways in which PCE may be used in these conditions of use, including
whether activities may take place in a closed system and the degree to
which users of PCE in these sectors could successfully implement an
ECEL, DDCC, and ancillary requirements described in Unit IV.A. For the
industrial and commercial use in laboratory chemicals, EPA is
soliciting comment on non-prescriptive requirements of an ECEL and DDCC
as compared to the prescriptive workplace controls of fume hood and
dermal PPE EPA is proposing in Unit IV.A.3.
As with the compliance timeframes considered as part of the primary
alternative action for prohibition, the primary alternative regulatory
action also includes longer compliance timeframes for implementation of
a PCE WCPP. Under the primary alternative action, the requirements for
the WCPP would take effect 6 months later than in the proposed
regulatory action. Under a compliance timeframe that is 6 months longer
than the proposed regulatory action, the requirements for owners and
operators to conduct initial baseline monitoring would take effect 12
months after the date of publication of the final rule in the Federal
Register. The requirements for each owner or operator to provide
respiratory protection to all potentially exposed persons in the
regulated area would be within 3 months after receipt of the results of
any exposure monitoring or within 15 months after date of publication
of the final rule in the Federal Register. Regulated entities would be
required to implement an exposure control plan within 18 months after
date of publication of the final rule in the Federal Register. EPA
requests comment on any advantages or drawbacks for the timelines
outlined in this unit compared to the timelines identified for the
proposed regulatory action in Unit IV.A.
c. Prescriptive Controls
The primary alternative regulatory action described in this
document would require prescriptive workplace PPE controls for the
following conditions of use (which are all conditions of use for which
EPA is proposing WCPP as part of the proposed regulatory action):
manufacturing (domestic manufacturing); manufacturing (import);
processing as a reactant/intermediate; processing into formulation,
mixture or reaction product in cleaning and degreasing products;
processing into formulation, mixture or reaction products in paint and
coating products; processing into formulation, mixture, or reaction
product in adhesive and sealant products; processing by repackaging;
recycling; industrial and commercial use as a solvent for open-top
batch vapor degreaser; industrial and commercial use as solvent for
closed-loop batch vapor degreasing; industrial and commercial use as
solvent for in-line conveyorized vapor degreasing; industrial and
commercial use as solvent for in-line web cleaner vapor degreaser;
industrial and commercial use in maskant for chemical milling; and
industrial and commercial use as processing aid in catalyst
regeneration in petrochemical manufacturing; and disposal.
Additionally, the primary alternative regulatory action described in
this document would require a concentration limit for the industrial
and commercial use in solvent-based adhesives and sealants.
i. Prescriptive controls--PPE. In the 2020 Risk Evaluation for PCE,
EPA identified gloves that would reduce dermal exposures to PCE. Under
the primary alternative regulatory action, EPA considered requiring
dermal PPE as described in Unit IV.A.2.c. This approach differs from
the proposed regulatory action because it does not require the use of
elimination, substitution, engineering controls and administrative
controls or work practices, in accordance with the hierarchy of
controls, to the extent feasible as a means of controlling dermal
exposures to comply with the DDCC. Rather, this approach would require
dermal PPE and training to prevent direct dermal contact with PCE as
described in Unit IV.A.2.c.iv. EPA is soliciting comment on prescribing
specific dermal PPE, such as gloves, for each condition of use that
should be considered as EPA develops the final regulatory action.
For inhalation exposures in the 2020 Risk Evaluation for PCE, EPA
identified APFs for respirators that would mitigate the unreasonable
risk for the conditions of use. However, as described in Unit V.A., EPA
has uncertainty that the respirator APF identified in the 2020 Risk
Evaluation for PCE for each condition of use is appropriate for the
wide variety of workplaces that may be engaged in each condition of
use, as each workplace has unique characteristics that impact PCE air
concentration levels. For example, EPA expects that some users may
already have existing controls in place that reduce PCE air
concentration levels below the ECEL (Refs. 49, 50), whereas other users
of the same condition of use have different workplace controls that
result in air concentration levels above the ECEL. Under the primary
alternative regulatory action, EPA considered setting minimum
respiratory PPE requirements based on an entity's measured air
concentration and the level of PPE needed to reduce exposures to the
ECEL, as described in Units IV.A.2.d.i. This approach differs from the
proposed regulatory action because it does not require the use of
elimination, substitution, engineering controls and administrative
controls or work practices, in accordance with the hierarchy of
controls, to the extent feasible as a means of controlling inhalation
exposures to comply with the ECEL. Rather, this approach would require
respirators where inhalation exposures exceed the ECEL based on
exposure monitoring. In addition to minimum respiratory PPE
requirements, the primary alternative regulatory action would require
initial monitoring within 12 months after publication of the final rule
and periodic monitoring once every five years to determine the
respiratory protection needed as described in Unit IV.A.2. as well as
establishment of a regulated area as described in Unit IV.A.2.,
establishment of PPE program as described in Unit IV.A.2. and
notification of monitoring results as described in Unit IV.A.2., with
modifications to not require implementation of all feasible exposure
controls according to the hierarchy of controls. EPA is soliciting
comment on prescribing specific respirators or APFs for respirators for
each condition of use that should be considered as EPA develops the
final regulatory action.
EPA understands that many workplaces already have engineering
controls or administrative controls in place that reduce exposures to
PCE, in particular highly standardized and industrialized workplaces or
where PCE is used in a closed system. However, EPA does not have
reasonably available information on engineering controls and
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administrative controls that would mitigate unreasonable risk across a
wide variety of workplaces for most occupational conditions of use. EPA
is requesting comment on specific controls that mitigate the
unreasonable risk from PCE and that could be included as part of a
prescriptive workplace controls requirement, which could be considered
as EPA develops the final regulatory action. Specifically, EPA is
soliciting comment on combinations of specific engineering controls,
administrative controls, and PPE that would reduce inhalation exposures
to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct
dermal contact with PCE for all workplaces where such controls would be
required. Examples of controls and workplace practices include a vapor
recovery system (e.g., carbon adsorption system or condenser), enclosed
transfer liquid lines (with purging mechanisms in place (e.g.,
nitrogen, aqueous), equipment such as portable scrubber units to
minimize vapor, ventilation units that mitigate vapor escape, and
limiting frequency and duration of exposure to PCE. For vapor
degreasing, EPA understands that the European Union and Germany have
established requirements for reducing emissions of volatile organic
compounds, such as the Solvent Emissions Directive and the German 2
BlmSchV standard for use of chlorinated hydrocarbons in surface
cleaning. EPA is soliciting comment on the extent to which such
requirements could reduce inhalation exposures to at or below the ECEL
of 0.14 ppm as an 8-hour TWA.
As with the compliance timeframes considered as part of the primary
alternative action for prohibition and WCPP, the primary alternative
regulatory action includes longer compliance timeframes for
implementation of prescriptive PPE controls. Under the primary
alternative action, the requirements for prescriptive controls would
take effect 6 months later than in the proposed regulatory action.
Under a compliance timeframe that is 6 months longer than the proposed
regulatory action, the requirements for owners and operators to provide
dermal PPE and training would take effect 18 months after the
publication date of the final rule. For respirator selection and
demarcating a regulated area, the requirements for owners and operators
to conduct initial baseline monitoring would take effect 12 months
after the date of publication of the final rule and requirements to
provide a respirator and demarcate a regulated area would take effect
18 months after the publication date of the final rule. EPA is
requesting comment on the compliance timeframe needed to implement
engineering controls, administrative controls, and PPE that reduce
inhalation exposures to at or below the ECEL of 0.14 ppm as an 8-hour
TWA or prevent direct dermal contact with PCE for all regulated
entities.
ii. Prescriptive controls--concentration limit. To reduce exposures
in the workplace and address the unreasonable risk of injury to health
from PCE for the industrial and commercial use in solvent-based
adhesives and sealants, EPA considered setting a concentration limit of
PCE in adhesive and sealant products. The primary alternative
regulatory action described in this document would limit the
concentration of PCE in adhesive and sealant products to 1% by weight.
Any percentage of PCE greater than 1% by weight would be prohibited for
the industrial and commercial use of solvent-based adhesive and
sealants products. Additionally, the primary alternative regulatory
action would prohibit the import, processing, and distribution in
commerce of adhesive and sealant products containing PCE at
concentrations greater than 1% by weight. EPA has uncertainty that a
concentration limit would reduce inhalation exposures such that PCE no
longer presents an unreasonable risk, and therefore did not propose a
concentration limit as the preferred option, as described in this Unit.
In the 2020 Risk Evaluation for PCE, EPA identified adhesive and
sealant products containing PCE at concentrations ranging from as low
as 0.1% PCE by weight to as high as 100% PCE by weight, including
several industrial adhesive products with concentrations of PCE below
1% by weight. In considering a concentration limit as a regulatory
action to address the unreasonable risk from inhalation and dermal
exposures for the industrial and commercial use of solvent-based
adhesives and sealants, EPA reviewed the dermal exposure modeling in
the 2020 Risk Evaluation for PCE and conducted additional analysis of
inhalation exposure data for adhesive products containing PCE below 1%
PCE by weight (Ref. 51). Based on the dermal exposure modeling in the
2020 Risk Evaluation for PCE, EPA determined that limiting the
concentration of PCE in adhesive and sealant products to 1% would
address the unreasonable risk resulting from dermal exposures (Ref.
52). In additional analysis of inhalation exposure data for adhesives
in support of risk management, EPA estimated inhalation exposures to
PCE from adhesives containing PCE at concentrations ranging from 0.1%
to 0.9% using four different approaches. In the analysis, inhalation
exposure estimates for central tendency in all four approaches resulted
in exposures below the ECEL. However, high-end exposure estimates
varied across the four approaches, with two approaches resulting in
high-end exposure estimates below the ECEL and two approaches resulting
in high-end exposure estimates above the ECEL.
The inhalation exposure estimates provided in the additional
inhalation analysis are a result of several key assumptions and
uncertainties, as described in the memo (Ref. 51). EPA therefore has
uncertainties regarding whether a concentration limit of 1% PCE in
adhesives and sealants would address the unreasonable risk resulting
from inhalation exposures in occupational settings. Therefore, EPA is
requesting comment on a combination of the 1% concentration limit for
adhesives and sealants with specific engineering controls,
administrative controls, or respiratory protection that would reduce
inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-
hour TWA. Additionally, EPA is requesting comment on a combination of a
concentration limit with WCPP requirements as described in Unit IV.A.2.
EPA also requests monitoring data, formulations used, and detailed
descriptions of PCE involving activities for the industrial and
commercial use in solvent-based adhesives and sealants to determine
whether a concentration limit would reduce inhalation exposures such
that risks are no longer unreasonable.
As part of the primary alternative regulatory action, the
concentration limit of 1% by weight of PCE for adhesive and sealant
products would only be for products intended for industrial and
commercial use. As described in Unit IV.B.1.a., the primary alternative
regulatory action would prohibit the manufacture, processing, and
distribution of PCE for consumer use, including consumer use in
adhesives for arts and crafts (including industrial adhesive, arts and
crafts adhesive, gun ammunition sealant, livestock grooming adhesive,
column adhesive, caulk and sealant). EPA examined the Consumer Exposure
Model for the 2020 Risk Evaluation for PCE and found that, when
adjusting parameters for product mass and duration of use to the
highest values based on consumer product data in the 2020 Risk
Evaluation for PCE for consumer adhesive conditions of use, limiting
the concentration of PCE to 1% by weight in consumer use of products
[[Page 39686]]
would not eliminate the unreasonable risk from PCE resulting from
inhalation and dermal exposures (Ref. 53).
Regarding compliance timeframes under the primary alternative
action, the prohibitions for the import, processing, distribution in
commerce, and use of adhesive and sealant products containing PCE at
concentrations greater than 1% by weight described in this unit would
take effect 18 months for importers, 21 months for processers, 24
months for distributing to retailers, 27 months for all other
distributors (including retailers), and 30 months for industrial and
commercial uses after the publication date of the final rule.
2. Second Alternative Regulatory Action Considered
The second alternative regulatory action, as with the proposed
regulatory action and the primary alternative regulatory action, is a
combination of prohibition and a WCPP to address the unreasonable risk
from PCE driven by the various conditions of use. While in most ways it
is similar to the proposed regulatory action, the second alternative
regulatory action differs from the proposed regulatory action by
prohibiting some conditions of use that would have requirements for a
WCPP under the proposed regulatory action. Additionally, the second
alternative regulatory action proposes a TSCA section 6(g) time-limited
exemption from prohibition for the industrial and commercial use of PCE
as maskant for chemical milling and the industrial and commercial use
of PCE for vapor degreasing. The second alternative regulatory action
also includes shorter compliance timeframes for prohibitions and a
WCPP, as described in this unit. EPA requests comment on this second
alternative regulatory action and whether any elements of this second
alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. EPA also
requests comment on any advantages or drawbacks for the timelines
outlined in this unit compared to the timelines identified for the
proposed regulatory action in Unit IV.A.
a. Prohibitions
The second alternative action would prohibit more occupational
conditions of use than the proposed regulatory action. In addition to
the conditions of use that EPA is proposing to prohibit in the proposed
regulatory action, the second alternative regulatory action described
in this action would also prohibit the following conditions of use:
processing into formulation, mixture or reaction product in paint and
coating products; processing into formulation, mixture, or reaction
product in cleaning and degreasing products; processing into
formulation, mixture or reaction product in adhesive and sealant
products; industrial and commercial use as solvent for open-top batch
vapor degreasing; industrial and commercial use as solvent for closed-
loop batch vapor degreasing; industrial and commercial use as solvent
for in-line conveyorized vapor degreasing; industrial and commercial
use as solvent for in-line web cleaner vapor degreasing; industrial and
commercial use in solvent-based adhesives and sealants; and industrial
and commercial use in maskants for chemical milling. Additionally, the
second alternative regulatory action would prohibit the manufacture,
processing, and distribution of PCE for consumer use.
Like the proposed action, the second alternative regulatory action
would also prohibit the manufacturing, processing, distribution in
commerce, 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.
However, the timeframes for the phaseout differ between the proposed
action and the second alternative action, described later in this unit.
As described in Unit IV.A.3., a prohibition on these conditions of use
would address the unreasonable risk driven by the following uses:
industrial and commercial use in dry cleaning and spot cleaning post-
2006 dry cleaning; industrial and commercial use in dry cleaning and
spot cleaning 4th/5th generation only dry cleaning; and consumer use in
dry cleaning solvent.
Regarding compliance timeframes, the second alternative regulatory
action would include more stringent timeframes for implementation of
prohibition than the proposed regulatory action. Additionally, EPA
would not stagger the compliance dates for manufacturers, processors,
and distributors. The prohibitions for the manufacturing, processing,
distribution in commerce, and use for certain industrial and commercial
uses described in this unit would take effect 12 months after the
publication date of the final rule. With regard to the compliance
timeframe for the manufacturing, processing, and distribution in
commerce for consumer use, under the second alternative regulatory
action, prohibitions described in this unit would take effect 12 months
after the publication date of the final rule. With regard to
prohibition of dry cleaning conditions of use, under the second
alternative regulatory action, the following would occur: prohibition
on the use of PCE in dry cleaning machines acquired after the effective
date of the final rule; a prohibition on the use of PCE in 3rd
generation machines 6 months after the publication date of the final
rule; a prohibition on the use of PCE in dry cleaning and spot cleaning
5 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 5 years after the publication date of
the final rule.
b. TSCA Section 6(g) Exemptions
Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if EPA makes one of three findings
required by the statute, as outlined in Unit IV.A.5. TSCA section
6(g)(2) requires EPA to analyze the need for the exemption, and to make
public the analysis and a statement on how the analysis was taken into
account when proposing an exemption under TSCA section 6(g). Based on
discussions with and information provided by industry stakeholders,
consultation with the DOD and NASA, and Panel recommendations in the
SBAR Panel Report (Ref. 33), EPA has analyzed the need for three
different exemptions and would grant two if the second alternative
regulatory action described in this document is adopted in the final
rule. This unit presents the results of that analysis.
i. Analysis of the need for a TSCA section 6(g)(1)(B) exemption for
industrial and commercial use of PCE in maskant for chemical milling
essential for national security and critical infrastructure. EPA has
conducted an analysis of the application of this rulemaking to the
industrial and commercial use of PCE in maskant for chemical milling
and found that a TSCA section 6(g) exemption may be warranted if the
second alternative regulatory action considered by EPA is adopted, in
its entirety or in relevant part, in the final rule. Based on
discussions with and information provided by industry stakeholders, EPA
understands that PCE-based maskant is used in commercial and defense
aerospace programs that are essential for national security and
critical infrastructure (Refs. 54, 55). For example, one facility that
comprises 85% of the U.S. market for PCE-based maskant chemical milling
uses PCE in the Boeing fuselage manufacturing program for the 737, 747,
767, and 777
[[Page 39687]]
and also in defense products for the Bell V-280 Valor, Boeing P-8,
Sikorsky CH-53K, Boeing KC-46, and Northrop Grumman B-21. Based on
information submitted by industry, the purpose of maskant in chemical
milling is to remove excess weight of aluminum not required for
structural integrity in commercial and defense products. This process
is performed on aluminum aircraft ``skins,'' which are large metal
sheets or panels. PCE is used at the beginning of the chemical milling
process as a temporary diluent for maskant applied to aircraft skins to
prevent chemical milling of certain areas. After application, the
maskant cover is scribed in specific locations and dry maskant is
pulled or removed, exposing aluminum metal, while the PCE evaporates
and is captured into a recovery system. Information submitted by
stakeholders notes that PCE does not remain on the airplane skins when
the skins are etched nor at any other point after the chemical milling
stage of fabrication.
According to information submitted by industry, PCE-based maskant
is required to meet certain performance requirements that other
alternatives are unable to meet. For example, PCE-based maskant meets
several Boeing Aircraft process specifications such as ``Chemical
Milling Aluminum Alloys'' (BAC 5772), ``Maskant Trimming of Fatigue
Critical Hardware'' (BAC 5986), ``Phosphoric Acid Anodizing of Aluminum
for Structural Bonding'' (BAC 5555), and ``Appearance Control of Clad
Aluminum Exterior Skins'' (Boeing D6-9002). These process
specifications are mandatory for suppliers as part of the quality
system that aircraft production certificate holders are required to
establish under 14 CFR 21.137. Additionally, PCE-based maskant also
meets other industry performance requirements such as Stretch Forming,
Laser Scribe Compatible, and General Parts Protection.
Representatives from the facility that comprises 85% of the U.S.
market for PCE-based maskant chemical milling have described to EPA how
efforts to develop new maskant have been ongoing for over 30 years but
have not yet found a substitute that meets all of the necessary
performance requirements (Ref. 54). PCE-based maskant also allows for
solvent capture and recycling. The same company has recaptured and
recycled more than 95% of the PCE used for more than 29 years, the
remaining PCE being captured using special filters, mats, and non-
recoverable mediums that are disposed of by a company that specializes
in providing environmental services for controlled chemicals (Ref. 55).
As discussed in this unit and in the Alternatives Assessment (Ref.
56), substitute chemicals for maskant for chemical milling may not meet
the performance requirements of maskant needed for chemical milling of
aluminum aircraft skins for commercial and defense purposes and thus
may not be technically feasible as alternatives. Therefore, EPA has
preliminarily determined that if PCE-based maskant were not available,
or if industry cannot meet the requirements of the WCPP in the proposed
regulatory action or of the prescriptive controls considered as the
primary alternative regulatory action, there would be a significant
disruption to national security and critical infrastructure. In
addition, due to availability concerns, EPA has preliminarily
determined that a ban on the manufacture, processing, and distribution
in commerce of PCE-based maskant could also significantly disrupt
national security and critical infrastructure. A prohibition on the use
of PCE for chemical milling of aluminum aircraft skins could affect the
ability to make available new military aircraft on schedule, and
consequently, potentially affect DOD's capability and readiness. Such a
prohibition would also affect the availability of new civilian aircraft
and thus have negative impacts on civilian aviation. Aviation has been
designated by the Department of Homeland Security as a key subsector in
the Transportation Systems Sector, one of 16 designated critical
infrastructure sectors.
Based on the expected significant disruption to national security
and critical infrastructure, a TSCA section 6(g) exemption may be
warranted if the proposed and primary alternative regulatory actions
are not suitable to address the unreasonable risk driven by this
condition of use. Therefore, as part of the second alternative
regulatory action, EPA would grant a 10-year exemption from prohibition
for the industrial and commercial use of PCE as maskant for chemical
milling. EPA believes that the information provided by industry on the
time needed to identify and qualify substitutes supports a 10-year
exemption period. Further, the industry submitter has provided
information demonstrating that engineering controls are already in
place to lower, to the extent possible, exposure concentrations to PCE
and to limit occupational exposures, including supplementing with PPE
during tasks that may result in greater exposure. Based on the
information submitted, EPA understands that existing controls ensure
airborne concentrations of PCE are generally kept below 1 ppm as an 8-
hour TWA (below the existing regulatory and voluntary occupational
exposure limits described in Units II.C.4. and 5.). While EPA
acknowledges that the airborne concentration may exceed the ECEL, the
exemption as part of the second alternative regulatory action would
include the following provisions to ensure that exposures are reduced
to the lowest levels achievable:: the proposed general recordkeeping
requirements discussed in Unit IV.A.4.i., documentation of the
engineering controls and PPE used to reduce potentially exposed
persons' exposure to the extent possible, and records that demonstrate
compliance with the exemption conditions, including the condition that
PCE only be used for chemical milling of aluminum aircraft skins.
EPA requests comments on all aspects of the section 6(g) exemption
from the prohibition on industrial and commercial use of PCE in maskant
for chemical milling as part of the second alternative regulatory
option, including information on the extent to which this industry
could meet the requirements of the proposed WCPP or prescriptive
controls, whether compliance with specific elements of the proposed
WCPP should also be required during the period of the exemption, and
the time period of the exemption pursuant to TSCA section 6(g)(3).
ii. Analysis of the need for a TSCA section 6(g)(1)(B) exemption
for industrial and commercial use of PCE in vapor degreasing essential
for national security and critical infrastructure. EPA has conducted an
analysis of the application of this rulemaking to the industrial and
commercial use of PCE in vapor degreasing and found that a TSCA section
6(g) exemption may be warranted if the second alternative regulatory
action considered by EPA is adopted, in its entirety or in relevant
part, in the final rule. EPA received a request for a section 6(g)
exemption from prohibition for the use of PCE in vapor degreasing of
aerospace parts from a manufacturer of commercial jetliners and
defense, space, and security systems (Refs. 57, 58). The aerospace
parts have commercial, DOD, and NASA uses (Ref. 59); as the requester
describes, they manufacture and procure these parts and have identified
that PCE vapor degreasing is necessary due to technical challenges with
other alternative substitute chemicals or methods.
The requester has spent many years developing, qualifying, and
implementing alternative materials and
[[Page 39688]]
processes to replace PCE vapor degreasing with aqueous cleaning where
technically viable. According to the requester, while the transition to
aqueous cleaning has been successful for many detail parts, there are
technical challenges with alternative substitute chemicals and
processes for the vast majority of complex aerospace machining parts
and actuation systems, such as structural components, gears, and other
parts that make up drive units and control mechanisms. The requester
states that PCE vapor degreasing is the best cleaning method to pre-
clean most complex machining parts and actuation systems because it
does not allow the transfer of contaminates from one part to another.
The requester notes that, for those parts approved for aqueous
cleaning, the parts so cleaned must be carefully segregated to avoid
cross-contamination, which substantially increases the required
processing time.
The requester notes that an adequate transition period for this
technically challenging aerospace use requires substantial investment
and time to develop viable alternatives. The requester is currently in
the process of identifying a replacement solvent that can adequately
clean, cause no harm to parts, and is not an equally toxic material to
PCE. Based on the submitted request, conversion from vapor degreasing
to aqueous cleaning is a capital-intensive investment that the
requester expects would require several years to plan, permit,
construct, and install. Additionally, the requester notes that the
aerospace industry needs to ensure that aerospace parts meet DOD and
other Federal Aviation Administration (FAA) specifications to ensure
safety of flight. For example, in order to replace the chemical with an
alternative, the requester notes that they must identify, test, and
select an alternative that meets technical requirements derived from
FAA mandated standards for a typical part used in a commercial
aircraft, such as specifications for specific gravity (ASTM D 792),
Water Absorption (ASTM D 750), and other test requirements, which may
be a lengthy process (Ref. 60). According to the information submitted,
certification with FAA could take at least nine months for individual
parts of components or up to several years for major subsystems or
complete aircraft (Ref. 60). The requester also notes that while they
do not know the extent that their supply chain has transitioned away
from use of PCE in vapor degreasing, PCE has been used in vapor
degreasing to meet required levels of cleanliness of certain supplied
parts by long-standing design specifications that are incorporated into
contracts of a complex supply chain. The requester also told EPA the
suppliers are not required to inform the requester of the process they
use to clean parts that the supplier provides to the requester, and the
requester therefore may not know which solvent a supplier has selected
for vapor degreasing or what factors were considered when selecting
cleaning systems. According to the requester, material declarations and
auditing processes to validate usage may be burdensome, considering
that a large portion of the requester's supply chain includes small
suppliers. Due to the concerns raised with transitioning to aqueous
cleaning or another new cleaning method, the requester has requested
that EPA exempt use of PCE in vapor degreasing of aerospace parts for
10 years.
As discussed in this unit, information submitted by the requester
indicates that substitute chemicals for vapor degreasing of aerospace
parts may not be technically feasible at this time for meeting the
cleanliness standards of certain parts as required by DOD and FAA
specifications or other specifications included in existing contracts
within the supply chain. According to the requester, more time is
needed for companies to make the capital-intensive transition from PCE
vapor degreasing to aqueous cleaning for those parts that can be
cleaned using the aqueous method. In addition, the requester states
that they are continuing to work towards identifying a replacement
solvent that is able to adequately clean complex machining parts and
actuation systems parts without harming them, and that is not a
regrettable substitution. Therefore, EPA has preliminarily determined
that if the use of PCE for vapor degreasing were not available in the
near term for aerospace parts, or if industry could not meet the
requirements of the WCPP as proposed or of the prescriptive controls
considered as the primary alternative regulatory action, compliance
with such requirements would significantly disrupt national security
and critical infrastructure. In addition, due to availability concerns,
EPA has preliminarily determined that a ban on the manufacture,
processing, and distribution in commerce of PCE for vapor degreasing of
aerospace parts could also significantly disrupt national security and
critical infrastructure. A prohibition on the use of PCE for vapor
degreasing of aerospace parts in the near term could negatively affect
DOD's capability and readiness, which includes the ability to
adequately maintain aircraft. Such a prohibition could also negatively
affect the maintenance of civilian aircraft and potentially have
impacts on the safety of civilian flight.
For the reasons discussed in this unit, EPA would grant a 10-year
exemption from prohibition as part of the second alternative regulatory
action for the industrial and commercial use of PCE in vapor degreasing
for aerospace parts. EPA believes that the information provided by the
requester on the time needed to identify and qualify substitutes
supports a 10-year exemption period. Further, the requester has
provided information demonstrating that engineering controls are in
place to lower, to the extent possible, exposure concentrations and
limit occupational exposures to PCE. The exemption would also include
the following conditions: the proposed general recordkeeping
requirements discussed in Unit IV.A.4.i., documentation of the
engineering controls used to reduce potentially exposed persons'
exposure, and records to demonstrate compliance with the exemption
conditions, including the condition that PCE only be used in vapor
degreasing for aerospace parts where other alternatives present
technical feasibility or cleaning performance challenges to meet DOD
and FAA specifications or other long-standing design specifications
that are included in existing contracts.
EPA requests comments on all aspects of the exemption request and
proposed exemption from the prohibition on use of PCE in vapor
degreasing as part of the second alternative regulatory action,
including information on the extent to which this industry could meet
the requirements of the proposed WCPP or prescriptive controls and
whether compliance with specific elements of the proposed WCPP should
also be required during the period of the exemption. EPA is requesting
comment on whether vapor degreasing of parts and components for non-
aerospace applications should also be exempt from prohibition as part
of the second alternative regulatory action for the industrial and
commercial use of PCE in vapor degreasing.
To facilitate EPA's consideration of exemptions for other sectors,
comments in support of additional exemptions should include detailed
explanations of why and how long exemptions would be needed.
Additionally, EPA is soliciting comment on whether it should specify
the type of vapor degreasing operation, such as closed-loop batch vapor
degreasing, that would
[[Page 39689]]
be exempt from prohibition as part of the second alternative regulatory
action for the industrial and commercial use of PCE in vapor degreasing
for aerospace parts and whether it should consider different exemption
timeframes for different types of vapor degreasing operations.
iii. Analysis of the need for a TSCA section 6(g) exemption for
industrial and commercial use of PCE in dry cleaning. Following Panel
recommendations in the SBAR Panel Report (Ref. 33), EPA has considered
a TSCA section 6(g) exemption for the use of PCE in dry cleaning and
has not found that a TSCA section 6(g) exemption is warranted. As
discussed in Units IV.A.1.c. and V.A.1., based on consideration of the
irreversible health effects associated with PCE exposures, the
uncertainty that this sector can comply with a WCPP and reduce
exposures sufficiently to address the unreasonable risk, and reasonably
available information that indicates that alternatives, such as high
flash point hydrocarbons and wet cleaning, are available, EPA
determined that a prohibition would be the most appropriate way to
eliminate the identified risks that drive the unreasonable risk to
health resulting from the following conditions of use: industrial and
commercial use in dry cleaning and spot cleaning post-2006 dry
cleaning; industrial and commercial use in dry cleaning and spot
cleaning 4th/5th generation only dry cleaning; and consumer use in dry
cleaning solvent (i.e., exposure to clothing or articles recently dry
cleaned with PCE). EPA has uncertainty regarding whether industrial and
commercial dry cleaning and spot cleaning users can comply with the
provisions of the WCPP, including reducing air concentration to below
the ECEL and complying with the WCPP implementation measures such as
periodic monitoring, a PPE program, and developing an exposure control
plan that reduces exposures in a manner aligns with the hierarchy of
controls where PPE is the least preferred option. This uncertainty
includes considerations of worker tasks that may occur in open-systems
or may require manual application or exposure to PCE or PCE-containing
products (e.g., manual stain removal, garment unloading, or
transferring solvent from storage container to machine that EPA
understands are common tasks at dry cleaning facilities) and
difficulties related to respiratory protection, as described in Unit
V.A. Based on reasonably available information, including market
research, existing State actions restricting the use of PCE in dry
cleaning, and engagement with industry, trade associations, and State
and local agencies, EPA has determined that a phaseout period of five
to fifteen years, as is included in the proposed regulatory action and
alternative regulatory actions, are reasonable compliance timeframes to
allow dry cleaners time to transition away from PCE. EPA requests
comments on all aspects of this analysis of a need for an exemption
under TSCA section 6(g), including information on the whether the
specific use may be critical or essential, the availability of
technically and economically feasible safer alternatives, and the time
needed to implement alternatives.
c. Workplace Chemical Protection Program (WCPP)
The second alternative regulatory action considered by EPA would
require a WCPP as described in Unit IV.A. for the following conditions
of use: manufacturing (domestic manufacturing); manufacturing (import);
processing as a reactant/intermediate; processing by repackaging;
recycling; industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing; and disposal. As
with the proposed regulatory action, under the second alternative
regulatory action, recycling and disposal would not be subject to the
WCPP ECEL requirements. As with the compliance timeframes considered as
part of the second alternative regulatory action for prohibition, the
second alternative regulatory action also includes shorter compliance
timeframes for implementation of the PCE WCPP than the proposed
regulatory action. Under the second alternative action, the
requirements for WCPP would take effect 3 months sooner than in the
proposed regulatory action. Under a compliance timeframe that is 3
months shorter than the proposed regulatory action, the requirements
for owners and operators to conduct initial baseline monitoring would
take effect 3 months after the date of publication of the final rule in
the Federal Register. Each owner or operator would be required to
provide respiratory protection to all potentially exposed persons in
the regulated area within 3 months after receipt of the results of any
exposure monitoring or within 6 months after date of publication of the
final rule in the Federal Register. Regulated entities would be
required to implement an exposure control plan within 9 months after
date of publication of the final rule in the Federal Register. EPA
requests comment on any advantages or drawbacks for the timelines
outlined in this unit compared to the timelines identified for the
proposed regulatory action in Unit IV.A.
d. Prescriptive Controls
The second alternative regulatory action considered by EPA would
require fume hood and dermal PPE for the industrial and commercial use
as a laboratory chemical, as described in Unit IV.A.3. As with the
compliance timeframes considered as part of the second alternative
action for prohibition and WCPP, the second alternative regulatory
action also includes shorter compliance timeframes for implementation
of prescriptive controls. Under the second alternative action, the
requirements for prescriptive controls would take effect 3 months
sooner than in the proposed regulatory action. Under a compliance
timeframe that is 3 months shorter than the proposed regulatory action,
requirements that owners and operators provide dermal PPE and a fume
hood would take effect 9 months after the publication date of the final
rule.
C. Overview of conditions of Use and Proposed Regulatory Action and
Alternative Regulatory Actions.
Table 2 is a side-by-side depiction of the proposed regulatory
action with the primary and second alternative actions for each
condition of use identified as driving the unreasonable risk (Ref. 2).
The purpose of this table is to succinctly convey to the public the
major differences between the proposed regulatory action and the
alternative regulatory actions; as such the actions in each column are
truncated and do not reflect all the details of the proposed and
alternative regulatory actions, including differences in timeframes.
The proposed and alternative regulatory actions are described more
fully in Units IV.A. and B.
[[Page 39690]]
Table 2--Overview of Conditions of Use Driving Unreasonable Risk and Proposed Regulatory Action and Alternative
Regulatory Actions
----------------------------------------------------------------------------------------------------------------
Action
Condition of use driving unreasonable --------------------------------------------------------------------------
risk determination Proposed regulatory Primary alternative Second alternative
action action action
----------------------------------------------------------------------------------------------------------------
Industrial and commercial use as a PCE WCPP............... Prescriptive Controls PCE WCPP.
processing aid in catalyst (PPE).
regeneration in petrochemical
manufacturing.
Industrial and commercial use in Prescriptive Controls PCE WCPP............... Prescriptive Controls
laboratory chemicals. (fume hood, dermal (fume hood, dermal
PPE). PPE).
Industrial and commercial use in PCE WCPP............... Prescriptive Controls Prohibit.\1\
paints and coatings in maskants for (PPE).
chemical milling.
Industrial and commercial use as PCE WCPP............... Prescriptive Controls Prohibit.\1\
solvent for open-top batch vapor (PPE).
degreaser.
Industrial and commercial use as PCE WCPP............... Prescriptive Controls Prohibit.\1\
solvent for closed-loop batch vapor (PPE).
degreaser.
Industrial and commercial use as PCE WCPP............... Prescriptive Controls Prohibit.\1\
solvent for in-line conveyorized (PPE).
vapor degreaser.
Industrial and commercial use as PCE WCPP............... Prescriptive Controls Prohibit.\1\.
solvent for in-line web cleaner (PPE).
vapor degreaser.
Industrial and commercial use as a Prohibit............... PCE WCPP............... Prohibit.
processing aid in pesticide,
fertilizer and other agricultural
chemical manufacturing.
Industrial and commercial use in Prohibit............... PCE WCPP............... Prohibit.
specialty DOD uses (oil analysis and
water pipe repair).
Industrial and commercial use in PCE WCPP............... Prescriptive Controls Prohibit.
solvent-based adhesives and sealants. (Concentration limit).
Industrial and commercial use in Prohibit............... PCE WCPP............... Prohibit.
solvent-based paints and coatings.
Industrial and commercial use as Prohibit............... PCE WCPP............... Prohibit.
solvent for aerosol spray degreaser/
cleaner.
Industrial and commercial use in dry Prohibit............... Prohibit............... Prohibit.
cleaning and spot cleaning post-2006
dry cleaning.
Industrial and commercial use in dry Prohibit............... Prohibit............... Prohibit.
cleaning and spot cleaning 4th/5th
gen only dry cleaning.
Industrial and commercial use as Prohibit............... Prohibit............... Prohibit.
solvent for cold cleaning.
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
other textile processing.
Industrial and commercial use in wood Prohibit............... Prohibit............... Prohibit.
furniture manufacturing.
Commercial use for photographic film. Prohibit............... Prohibit............... Prohibit.
Industrial and commercial use as a Prohibit............... Prohibit............... Prohibit.
solvent for aerosol lubricants.
Industrial and commercial use in wipe Prohibit............... Prohibit............... Prohibit.
cleaning.
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
other spot cleaning and spot
removers, including carpet cleaning.
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
automotive care products (e.g.,
engine degreaser and brake cleaner).
Industrial and commercial use in non- Prohibit............... Prohibit............... Prohibit.
aerosol cleaner.
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
metal (e.g., stainless steel) and
stone polishes.
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
foundry applications.
Commercial use in inks and ink Prohibit............... Prohibit............... Prohibit.
removal products (based on printing).
Industrial and commercial use in Prohibit............... Prohibit............... Prohibit.
welding.
Industrial and commercial use for Prohibit............... Prohibit............... Prohibit.
mold release.
Commercial use in inks and ink Prohibit............... Prohibit............... Prohibit.
removal products (based on
photocopying).
Commercial use in metal mold Prohibit............... Prohibit............... Prohibit.
cleaning, release and protectant
products.
Industrial and commercial use as a Prohibit............... Prohibit............... Prohibit.
solvent for penetrating lubricants
and cutting tool coolants.
Consumer use in dry cleaning solvent. Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
Consumer use in automotive care Prohibit \2\........... Prohibi \2\............ Prohibit.\2\
products (parts cleaner).
Consumer use in lubricants and Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
greases (lubricants and penetrating
oils).
Consumer use in adhesives for arts Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and crafts (including industrial
adhesive, arts and crafts adhesive,
gun ammunition sealant).
Consumer use in adhesives for arts Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and crafts (livestock grooming
adhesive).
Consumer use in adhesives for arts Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and crafts (column adhesive, caulk
and sealant).
[[Page 39691]]
Consumer use in solvent-based paints Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and coatings (coatings and primers
(aerosol)).
Consumer use in solvent-based paints Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and coatings (metallic overglaze).
Consumer use in welding.............. Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
Consumer use in metal mold cleaning, Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
release and protectant products.
Consumer use in cleaners and Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
degreasers (other).
Consumer use in automotive care Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
products (brake cleaner).
Consumer use in aerosol cleaner Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
(vandalism mark and stain remover).
Consumer use in non-aerosol cleaner Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
(e.g., marble and stone polish).
Consumer use in lubricants and Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
greases (cutting fluid).
Consumer use in solvent-based paints Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and coatings (outdoor water shield
(liquid)).
Consumer use in solvent-based paints Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
and coatings (rust primer and
sealant (liquid)).
Consumer use in metal (e.g., Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
stainless steel) and stone polishes.
Consumer use in inks and ink removal Prohibit \2\........... Prohibit \2\........... Prohibit.\2\
products.
Manufacturing (domestic PCE WCPP............... Prescriptive Controls PCE WCPP.
manufacturing). (PPE).
Manufacturing (import)............... PCE WCPP............... Prescriptive Controls PCE WCPP.
(PPE).
Processing as a reactant/intermediate PCE WCPP............... Prescriptive Controls PCE WCPP.
(PPE).
Processing into formulation, mixture PCE WCPP............... Prescriptive Controls Prohibit.
or reaction product in paint and (PPE).
coating products.
Processing into formulation, mixture PCE WCPP............... Prescriptive Controls Prohibit.
or reaction product in cleaning and (PPE).
degreasing products.
Processing into formulation, mixture Prohibit............... PCE WCPP............... Prohibit.
or reaction product in other
chemical products and preparations.
Processing into formulation, mixture PCE WCPP............... Prescriptive Controls Prohibit.
or reaction product in adhesive and (PPE).
sealant products.
Repackaging.......................... PCE WCPP............... Prescriptive Controls PCE WCPP.
(PPE).
Recycling............................ PCE WCPP............... Prescriptive Controls PCE WCPP.
(dermal PPE).
Disposal............................. PCE WCPP............... Prescriptive Controls PCE WCPP.
(dermal PPE).
----------------------------------------------------------------------------------------------------------------
\1\ TSCA section 6(g) exemption, including the manufacture (including import), processing, and distribution for
this condition of use.
\2\ Prohibit manufacture (including import), processing, and distribution in commerce for the consumer use.
V. Rationale for the Proposed Regulatory Action and Alternative
Regulatory Actions
This unit describes how the considerations described in Unit
III.B.3. were applied when selecting among the TSCA section 6(a)
requirements to arrive at the proposed and alternative regulatory
actions described in Unit IV.
A. Consideration of Risk Management Requirements Available Under TSCA
Section 6(a)
1. Proposed Regulatory Action
a. Prohibition
EPA considered a prohibition as a regulatory option and is
proposing it for certain occupational conditions of use (Unit IV.A.).
Prohibition is the preferred option for occupational conditions of use
where greater uncertainty exists relative to a sector's ability to
comply with provisions of the proposed PCE WCPP, such as an ECEL or
DDCC. EPA's 8-hour TWA ECEL for PCE is significantly lower than the
OSHA PEL and there is a degree of uncertainty as to whether chemical
users under the conditions of use in some sectors will be able to
comply with such a level and thus whether the unreasonable risk would
be addressed. This uncertainty includes consideration of the
difficulties related to respiratory protection, which are discussed in
more detail in Unit V.A.1.b., and which include how respirators may
present communication problems, vision problems, worker fatigue, and
reduced work efficiency (63 FR 1152, January 8, 1998) as well as
consideration for that fact that not all workers may be able to wear
respirators. Similarly, there is also uncertainty regarding certain
chemical users' ability to prevent direct dermal contact with PCE, in
particular during use in open-systems or when worker activities require
manual application or removal of PCE or a PCE-containing product
through rags, aerosols, spray guns, roll applicators, fingers, hands,
or other materials. Additionally, prohibition is the preferred option
for occupational conditions of use where reasonably available
information suggests minimal ongoing use or when feasible safer
alternatives are reasonably available. The uncertainties related to
whether users under certain conditions of use could comply with the
requirements of a PCE WCPP, combined with the severity of the risks of
PCE, the prevalence of alternative processes and products (Unit V.B),
and in some cases reasonably available information indicating a use is
no longer ongoing (Refs. 56, 3), has led EPA to propose prohibitions
for most industrial and
[[Page 39692]]
commercial uses of PCE, as well as for the upstream manufacturing,
processing, and distribution in commerce for those uses. EPA requests
comment regarding the number of businesses and other entities that
could potentially close as well as associated costs with a prohibition
of PCE for the industrial and commercial conditions of use identified
in Unit IV.A.1.
As outlined in Unit IV.A.1., EPA is proposing to phase out the use
of PCE in dry cleaning and associated spot cleaning at dry cleaning
facilities. While EPA recognizes the exposure reductions and
significant investments in equipment improvements made by dry cleaners,
as described by SERs and summarized in the SBAR Panel Report (Ref. 33),
EPA has determined that the industrial and commercial uses of PCE in
dry cleaning and the consumer use of PCE in dry cleaning drive the
unreasonable risk for PCE, and is proposing that prohibition is the
most appropriate approach to eliminate the unreasonable risk. Following
the Panel recommendations in the SBAR report (Ref. 33), EPA is
providing an assessment on the impact of the rule on the dry cleaning
industry in the Economic Analysis (Ref. 3), summarized here. Based on
consultation with stakeholders, EPA understands that the use of PCE in
dry cleaning is currently declining. Stakeholders, including State and
Local Agencies and trade associations, have noted an overall year-to-
year decline in the use of PCE in dry cleaning and many expect PCE to
phase out naturally or decrease to extremely low numbers as older
machines are retired and alternative solvents are adopted (Ref. 61). As
described more fully in the Economic Analysis, 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 Unit IV.A.1. Additionally, reasonably available information
on the current use of alternatives to PCE in dry cleaning, including
cost, effectiveness, and safety, indicate suitable alternatives are
available (Refs. 61, 62). As described more fully in the Economic
Analysis, EPA expects that multi-solvent or hydrocarbon dry cleaning
machines are likely to be the most common alternatives to PCE dry
cleaning. However, other alternatives, such as wet cleaning, are
available (Refs. 27, 28, 29, 30, 31).
EPA determined prohibition would not be suitable for the remaining
occupational conditions of use, such as processing as a reactant/
intermediate and several types of processing into a formulation,
mixture, or reaction product; and industrial and commercial uses as a
solvent for cleaning and degreasing in vapor degreasers, particularly
for aerospace and defense applications, in maskant for chemical
milling, in solvent-based adhesives and sealants, as a processing aid
in catalyst regeneration in petrochemical manufacturing, and as a
laboratory chemical. EPA made this determination based on compelling
reasons to not prohibit the activity and identification of a different
regulatory action that would address the unreasonable risk. For
example, prohibition may not be suitable for conditions of use that may
complement the Agency's efforts to address climate-damaging HFCs under
the AIM Act, or have national security or other significance for
critical sectors, where EPA identified strict workplace controls could
be implemented for these uses to address the unreasonable risk as
described in Unit V.A.1.b. Additionally, prohibition may not be
suitable for conditions of use where alternative substances to PCE are
more or equally hazardous, in particular for other solvents undergoing
risk evaluation and risk management under TSCA section 6. For example,
for processing as a reactant/intermediate, PCE and trichloroethylene
(TCE) are both used as feedstock in the manufacture of HFC-134a
although they are not drop in substitutes. As another example, PCE,
TCE, 1-bromopropane, methylene chloride, and trans-1,2-dichloroethylene
are solvents used in vapor degreasing and have or are currently
undergoing risk evaluation or risk management under TSCA. In selecting
among the TSCA section 6(a) requirements for the proposed approach for
conditions of use where alternative substances to PCE may include other
solvents undergoing risk evaluation and risk management under TSCA
section 6, EPA considered whether technically and economically feasible
alternatives that benefit health or the environment will be reasonably
available as a substitute.
For these conditions of use, EPA determined restrictions under a
PCE WCPP were more suitable for addressing the unreasonable risk to the
extent necessary so that PCE no longer presents such risk, while also
allowing flexibility for regulated entities to continue operations, as
described in this unit and in Unit IV.A.
Regarding industrial, commercial, and consumer uses of PCE, TSCA
section 6(a)(2) provides EPA with the authority to prohibit or
otherwise restrict the manufacture (including import), processing, or
distribution in commerce of a substance or mixture ``for a particular
use'' to ensure that a chemical substance no longer presents
unreasonable risk. For this rule, EPA proposes that ``for a particular
use'' includes consumer use more broadly, as well as industrial and
commercial use, which encompasses all known, intended, and reasonably
foreseen uses of PCE. Given the severity and ubiquitous nature of the
risks identified in the 2020 Risk Evaluation for PCE for all
industrial, commercial, and consumer uses evaluated, and noting that
those conditions of use evaluated in the Risk Evaluation encompass all
known, intended, and reasonably foreseen uses of PCE, EPA proposes that
prohibiting manufacture (including import), processing, and
distribution in commerce of PCE for most industrial and commercial use
and all consumer use is reasonable and necessary to eliminate the
unreasonable risk of PCE, including by precluding retailers from
selling PCE and PCE-containing products to consumers. EPA believes that
any retailer selling PCE-containing products to consumers would be
selling products for one of the consumer uses EPA evaluated in the 2020
Risk Evaluation for PCE and found to drive the unreasonable risk for
PCE. Other regulatory options that would restrict the manufacture
(including import), processing, and distribution in commerce of PCE for
consumer use, such as setting a concentration limit, would not
adequately address the identified unreasonable risk driven by consumer
use. EPA's proposed requirements to address unreasonable risk to
consumers and bystanders to consumer use are described in Unit IV.A.
A key consideration regarding consumer use is the role of retailers
and other distributors. A retailer, as EPA has defined in 40 CFR
751.103 (and proposes to define in 40 CFR 751.5), is any entity that
makes available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Previously, in the
2019 methylene chloride TSCA section 6(a) risk management rule
addressing consumer use of methylene chloride in paint and coating
removal (40 CFR part 751, subpart B), EPA prohibited retailers from
distributing in commerce paint and coating removers containing
methylene chloride (see 40 CFR 751.105(b) and (c)). To meet the same
goal of protecting consumers from accessing PCE-containing products
that
[[Page 39693]]
could pose unreasonable risk, for a broader range of consumer
conditions of use, EPA considered and is proposing a similar provision
to ensure that retailers will not be able to purchase PCE for sale or
distribution to consumers and will not be able to sell or distribute
PCE to consumers, including making available to consumers products
containing PCE. For these reasons, as described in Unit IV.A., EPA's
proposal to address unreasonable risk from PCE includes prohibition on
the distribution in commerce of PCE to and by retailers.
To support implementation of the proposed prohibitions EPA also
considered, and is proposing, a de minimis level for products
containing PCE to account for impurities that do not drive the
unreasonable risk. EPA conducted an analysis using the methodology in
the 2020 Risk Evaluation for PCE to estimate whether there is a weight
fraction of PCE in industrial/commercial and consumer products below
which the industrial/commercial and consumer uses of those products,
respectively, would not drive the unreasonable risk from PCE. EPA
examined the Consumer Exposure Model for the 2020 Risk Evaluation for
PCE and found that, when adjusting parameters for product mass and
duration of use to the highest values based on consumer product data in
the 2020 Risk Evaluation for PCE, consumer use of products that are
0.124% PCE or less by weight would not drive the unreasonable risk from
PCE (Ref. 53). To identify a concentration limit of PCE in industrial/
commercial products that would not drive the unreasonable risk from
PCE, EPA also conducted an analysis using the Brake Servicing Near-
Field/Far-Field exposure model in the 2020 Risk Evaluation for PCE and
calculated that a PCE concentration of 0.7% in aerosol brake degreasing
products would achieve exposure concentrations at or below the ECEL
based on a near-field 8-hour TWA of 0.145 ppm at the 95th percentile
(Ref. 45). Based on these analyses, EPA is proposing to exclude from
prohibition products containing PCE at less than 0.1% by weight, as
described in Unit IV.A. EPA has identified uncertainties with a
concentration limit of 0.1% addressing the unreasonable risk. For
example, the Brake Services Near-Field/Far-Field exposure model is
based on a scenario for occupational brake cleaning and may less
accurately estimate exposures from other applications where exposures
may be different than those predicted by the model, for example due to
higher PCE application rates or lower ventilation rates. However, a
concentration limit of 0.1% provides a margin of error to account for
the uncertainties associated with the 0.7% concentration limit
identified in the analysis using the Brake Servicing Near-Field/Far-
Field exposure model. EPA is requesting comment on the de minimus
concentration limit of PCE in products or formulations, and provides
more information on consideration of a concentration limit in Unit
V.A.3. Details of the proposed prohibitions are described in more
detail in Unit IV.A.
b. Workplace Chemical Protection Program (WCPP)
One option EPA considered for occupational conditions of use was
establishing requirements for a PCE WCPP, which would include a
combination of requirements to the extent necessary to address
unreasonable risk driven by inhalation and dermal exposures in the
workplace. A PCE WCPP would encompass restrictions on certain
occupational conditions of use and could include provisions for an
ECEL, DDCC, and ancillary requirements to support implementation of
these exposure limits. Due to the low exposure level and stringent
requirements in the PCE WCPP that would be necessary to address the
unreasonable risk from PCE, EPA identified only a relatively small
number of conditions of use where the Agency expected a PCE WCPP could
be successfully implemented.
Existing Chemical Exposure Limit. One requirement considered by EPA
to include in a PCE WCPP to address unreasonable risk driven by
inhalation exposures to PCE for occupational conditions of use was
establishing an ECEL and related implementation measures, such as
exposure monitoring. As described in Unit IV.A., the PCE WCPP would be
non-prescriptive, in the sense that regulated entities would not be
required to use specific controls prescribed by EPA to achieve the
exposure concentration limit. Rather, it would be a performance-based
exposure limit that would enable owners or operators to determine how
to most effectively meet the exposure limit based on conditions at
their workplace, consistent with the hierarchy of controls.
A central component of the PCE WCPP is the exposure limit.
Exposures remaining at or below the ECEL would address any unreasonable
risk of injury to health driven by inhalation exposures for
occupational conditions of use.
In the case of PCE, EPA has calculated the ECEL to be 0.14 parts
per million (ppm) (0.98 mg/m\3\) for inhalation exposures as an 8-hour
TWA in workplace settings, based on the chronic, non-cancer HEC for
neurotoxicity (CNS) (Ref. 10). This is the concentration at which an
adult human, including a member of a susceptible subpopulation, would
be unlikely to suffer adverse effects if exposed for a working
lifetime. The differences between the ECEL and the OSHA PEL are
discussed in more detail in Unit II.C.1.b. EPA chose the chronic non-
cancer neurotoxicity endpoint for PCE as the basis for this exposure
limit because it is the most sensitive of the endpoints identified, and
therefore will be protective of both acute and chronic non-cancer and
chronic cancer inhalation endpoints over the course of a working day
and lifetime.
In deciding whether an ECEL and related required implementation
measures would appropriately address the unreasonable risk driven by
occupational inhalation exposures for specific conditions of use, EPA
considered factors related to work activities that may make it
difficult to comply with an ECEL, particularly at the low air
concentration level EPA has identified. Once EPA identified the
appropriate risk-based inhalation limit to address identified
unreasonable risk, EPA carefully considered the appropriateness of such
an exposure control program for each occupational condition of use of
PCE, in the context of the unreasonable risk. Examples include
conditions of use with work activities that may take place in the
field, making it challenging to establish a regulated area and conduct
monitoring; work activities that may take place in open systems that
require manual contact with the chemical substance; work activities
that may take place in small, enclosed spaces, creating challenges for
implementing engineering controls or using respiratory PPE; work
activities that require a high range of motion or for some other reason
create challenges for the implementation of respiratory PPE; and the
type of PPE that would be needed under the PCE WCPP to meet the ECEL in
the absence of, or in addition to, other feasible exposure controls,
based on analysis in the 2020 Risk Evaluation for PCE describing
expected exposures with and without use of PPE.
EPA also considered the feasibility of exposure reduction
sufficient to address the unreasonable risk, including in facilities
currently complying with the OSHA PEL for PCE or implementing other
recommended OELs such as the ACGIH TLV. While EPA acknowledges the
regulated community's expected familiarity with OSHA PELs generally, as
well as facilities' past and ongoing
[[Page 39694]]
actions to implement the PCE PEL, the value of EPA's exposure limit is
almost three orders of magnitude lower than the OSHA PEL (The
differences between the ECEL and the OSHA PEL are discussed in more
detail in Unit II.C.4; more information on other OELs is in Unit
II.C.5.). This creates a degree of uncertainty as to whether facilities
engaging in most conditions of use could meet the ECEL (and associated
action level) and whether they could do so without relying primarily on
the use of PPE (which is the least preferred option in the hierarchy of
controls), and, therefore, whether exposures could be reduced in a
manner aligned with the hierarchy of controls.
EPA understands that this uncertainty extends to the feasibility of
respirators as well. Although respirators, specifically SCBAs, could
reduce exposures to levels that protect against non-cancer and cancer
risks, not all workers may be able to wear respirators. Individuals
with impaired lung function due to asthma, emphysema, or chronic
obstructive pulmonary disease, for example, may be physically unable to
wear a respirator. OSHA requires that a determination regarding the
ability to use a respirator be made by a physician or other licensed
health-care professional, and annual fit testing is required for tight-
fitting, full-face piece respirators to provide the required
protection. Individuals with facial hair, such as beards or sideburns
that interfere with a proper face-to-respirator seal, cannot wear tight
fitting respirators. In addition, respirators may also present
communication problems, vision problems, worker fatigue, and reduced
work efficiency (63 FR 1152, January 8, 1998). According to OSHA,
``improperly selected respirators may afford no protection at all (for
example, use of a dust mask against airborne vapors), may be so
uncomfortable as to be intolerable to the wearer, or may hinder vision,
communication, hearing, or movement and thus pose a risk to the
wearer's safety or health.'' (63 FR 1189-1190).
Direct dermal contact control requirements. Another requirement
considered by EPA to include in a PCE WCPP to address unreasonable risk
driven by dermal exposures to PCE for occupational conditions of use
was requiring DDCC. DDCC under the PCE WCPP would be a process-based
requirement to prevent direct dermal contact in the workplace by
separating, distancing, physically removing, or isolating potentially
exposed persons from direct handling of PCE or from contact with
equipment or materials on which PCE may exist under routine conditions.
Similar to the ECEL, DDCC is non-prescriptive, in the sense that it
would not require a specific control to prevent direct dermal contact;
rather, it would enable regulated entities to determine how to most
effectively separate, distance, physically remove, or isolate
potentially exposed persons from direct dermal contact with PCE based
on what works best for their workplace, in accordance with the
hierarchy of controls.
In deciding whether DDCC would appropriately address the
unreasonable risk driven by dermal exposures, EPA considered factors
related to work activities that may make it difficult to eliminate
direct dermal contact. Examples include work activities that may take
place in open systems that require manual handling of PCE, such as
application or removal of PCE or a PCE-containing product through rags,
aerosols, spray guns, roll applicators, fingers, hands, or other
materials; or work activities that require a high range of motion or
for some other reason create challenges for the implementation of
dermal PPE.
EPA also considered whether exposures could be reduced in a manner
aligned with the hierarchy of controls and considered the type of PPE
that would be needed under the PCE WCPP DDCC to prevent direct dermal
contact if elimination, substitution, engineering controls, and
administrative controls are not sufficient to prevent direct dermal
contact. The 2020 Risk Evaluation for PCE describes expected exposures
with and without use of PPE; even if chemically resistant gloves are
used in combination with basic workplace training and specific activity
training for tasks where dermal exposure can be expected to occur, EPA
found that dermal exposures would continue to pose risk concerns for
most conditions of use. However, the 2020 Risk Evaluation for PCE
identifies several uncertainties regarding the dermal exposures
modeled. For example, the 2020 Risk Evaluation for PCE does not
consider the frequency, type, and effectiveness of gloves or other
types of PPE used or specific workplaces. In addition, the 2020 Risk
Evaluation for PCE does not specify the specific activity training
beyond procedure for glove removal and disposal.
In consideration of the whole of the 2020 Risk Evaluation for PCE,
including the uncertainties, EPA has preliminarily determined that
preventing direct dermal contact to PCE through DDCC requirements,
including requirements to reduce exposures in a manner aligned with the
hierarchy of controls, workplace specific training, and, if necessary,
dermal PPE which covers any exposed skin (including hands, legs, torso,
and face), and PPE training, as described in Unit IV.A.2., for certain
occupational conditions of use would address the unreasonable risk from
dermal exposure driven by these conditions of use for potentially
exposed persons.
PCE WCPP. Taking into account these considerations, EPA is
proposing that certain conditions of use would be allowed to continue
if regulated entities could ensure exposures remain at or below the
ECEL, direct dermal contact is prevented, and other requirements are
met in the PCE WCPP. In contrast to considerations that would weigh
against the likelihood of a facility within a condition of use to
successfully implement WCPP, there are certain considerations that
indicate a condition of use would likely be able to achieve effective
risk management via WCPP. Based on reasonably available information,
including monitoring data (Refs. 50, 49), process descriptions, and
information related to considerations described previously in this
unit, EPA's confidence that requirements to meet an ECEL and prevent
direct dermal contact can be implemented is highest in highly
standardized and industrialized settings, such as where PCE is used in
a closed system.
For example, one of the conditions of use for which EPA is
proposing a WCPP is processing of PCE as a reactant. A large volume of
PCE is processed for this condition of use, which primarily goes
towards the manufacture of HFC-134a and HFC-125 (Refs. 3, 36).
Inhalation monitoring data submitted by industry suggests that PCE
exposures in some facilities may already be below levels that would be
consistent with the proposed ECEL (Ref. 36). Additionally, the 2020
Risk Evaluation for PCE supports EPA's conclusion that only small
reductions in exposure are needed for WCPP ECEL compliance for
processing of PCE as a reactant. Based on analysis in the 2020 Risk
Evaluation for PCE describing expected exposures with and without use
of PPE, EPA identified respirators of APF 25 as the minimum respiratory
PPE that is sufficient to mitigate the unreasonable risk driven by
inhalation exposures from this condition of use. Also, for dermal
exposures, reasonably available information indicates that controls may
already be in place at some workplaces to prevent or reduce direct
dermal contact with PCE, including enclosed transfer liquid lines with
a nitrogen purging mechanism, closed loop samplers, and impervious
glove liners
[[Page 39695]]
in addition to chemically resistant gloves (Ref. 63).
Another condition of use for which EPA is proposing the WCPP is the
industrial and commercial use of PCE as a processing aid in catalyst
regeneration in petrochemical manufacturing. EPA understands that most
workplaces using PCE in isomerization and catalytic reforming (the two
uses of PCE in catalyst regeneration in petrochemical manufacturing)
already have stringent controls in place that reduce workplace
exposures. As described in public comments and through engagement with
the American Fuel and Petrochemical Manufacturers (AFPM), other
industry trade associations, and individual firms, petroleum refineries
use PCE in continuous, closed processes, where it is completely
consumed (Refs. 64, 66, 63). Stakeholders have described how, upon
delivery by tote or tank truck at refineries, PCE is directly injected
from a tote into a closed processing unit or transferred from a truck
into a storage tank that is directly hooked up for direct injection in
a closed system. Transfer procedures of PCE are performed pursuant to
comprehensive written procedures under strict PPE guidelines including,
when appropriate, respirators. Information submitted by AFPM indicates
that worker exposure is limited to chemical unloading and transfer
procedures, which, for AFPM members, may range from 10 to 35 times per
year per site for a 15-minute tote changeout or two to 12 times per
year per site for a 30- to 60-minute tank truck transfer (Ref. 64).
While EPA understands that the PCE exposure frequency and duration
at petroleum refineries may be less than what was assumed in the risk
evaluation, as described in this unit, EPA does not have any recent air
monitoring data to confirm that PCE exposures are below the proposed
ECEL at petroleum refineries. Based on analysis in the 2020 Risk
Evaluation for PCE describing expected exposures with and without use
of PPE, EPA identified respirators of APF 10 as the minimum respiratory
PPE that would be sufficient to mitigate the unreasonable risk driven
by inhalation exposures from this condition of use. Also, for dermal
exposures, reasonably available information indicates that controls may
already be in place to prevent or reduce direct dermal contact with
PCE, such as using PCE in a closed system to limit exposures and
implementing comprehensive written procedures with added PPE during
transfer procedures.
For both of these conditions of use (processing as a reactant/
intermediate and industrial and commercial use in catalyst regeneration
in petrochemical manufacturing) the 2020 Risk Evaluation for PCE
indicates that only small reductions in exposure would be needed for
WCPP compliance. This suggests that, for these conditions of use, the
reductions in exposure required to achieve a level that would not
result in unreasonable risk may be less than for other conditions of
use. This information together with other considerations previously
described, including monitoring data indicating exposures near or below
the ECEL and other reasonably available information indicating
stringent controls may already be in place, adds to EPA's confidence
that facilities engaging in these two conditions of use could meet the
WCPP requirements.
In addition to EPA's confidence that facilities engaging in these
conditions of use could meet the WCPP requirements and thus address the
unreasonable risk, EPA found compelling reasons to allow continued use
of PCE for these conditions of use because they may complement the
Agency's efforts to address climate-damaging HFCs under the AIM Act or
have national security or other significance for critical sectors. For
processing of PCE as a reactant/intermediate, HFC-134a and HFC-125 are
two of the regulated substances identified in the AIM Act. The AIM Act
authorizes EPA to address listed HFCs in three main ways: phasing down
HFC production and consumption through an allowance allocation program;
facilitating sector-based transitions to next-generation technologies;
and issuing certain regulations for purposes of maximizing reclamation
and minimizing releases of HFCs from equipment and ensuring the safety
of technicians and consumers. EPA anticipates that many entities
currently using HFCs with higher global warming potential will
transition to alternatives with lower global warming potential as
requirements under the AIM Act take effect. HFC-134a and HFC-125, while
being regulated substances subject to the overall phasedown in
production and consumption of regulated substances under the AIM Act,
are likely to be used in blends to facilitate the transition from other
HFCs and HFC blends with higher global warming potential in certain
applications. By allowing for the continued, controlled use of PCE in
the manufacture of HFC-134a and HFC-125, efforts to shift to chemicals
or blends with lower global warming potential would not be impeded by
this rulemaking. Allowing this use to continue, subject to compliance
with the WCPP, would complement industry's ongoing effort to abate the
use of HFCs with higher global warming potential.
For the industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing, information
submitted to the Agency indicates that isomerization and catalytic
reforming processes, which may rely on PCE for catalyst regeneration,
are essential to make gasoline that is compliant with environmental
regulations, such as the EPA Mobile Source Air Toxics regulations (Ref.
64, 65). Isomerization is a process that reduces the amount of benzene
in fuels and catalytic reforming generates hydrogen that is used to
remove sulfur compounds (Ref. 64). The resulting products from
isomerization and catalytic reforming processes at petroleum refineries
are isomerate and reformate, which go into gasoline blends that make up
an estimated 45% of the gasoline pool in the United States (Ref. 64).
Based on information submitted to the Agency, EPA believes that
petroleum refineries can meet the ECEL, and so does not anticipate that
there would be a meaningful impact on the price of gasoline. However,
if petroleum refineries are unable to meet or are not already meeting
WCPP requirements as part of the proposed regulatory action and second
alternative regulatory action or the prescriptive controls as part of
the primary alternative action, EPA understands that this rulemaking
could result in larger impacts to the petroleum refining sector, with
potential impacts that could include an increase in the price of
gasoline. Therefore, EPA is requesting comment on the extent to which
facilities engaged in the industrial and commercial use of PCE as a
processing aid in catalyst regeneration in petrochemical manufacturing
may already meet the requirements in the proposed and alternative
regulatory actions described in Unit IV. to address the unreasonable
risk and is soliciting comment on the impact of such requirements on
petroleum refining, with special attention to the price of gasoline.
For PCE to be available for the downstream industrial and
commercial uses that would continue under a PCE WCPP, it would need to
be manufactured (including imported), processed, and distributed in
commerce. Likewise, as long as PCE remains in use, it must also be
disposed of. Therefore, EPA is proposing requirements to meet a PCE
WCPP for manufacture (including import), certain processing conditions
of use, and disposal, to allow for a continued supply chain for
specified
[[Page 39696]]
conditions of use while ensuring that workers are not subject to
unreasonable risk from PCE as it moves throughout the supply chain. For
recycling and disposal, EPA did not identify human health risk from
inhalation exposure as a driver of unreasonable risk and is therefore
not proposing to require an ECEL under the PCE WCPP for recycling and
disposal activities.
Details of the proposed PCE WCPP, including provisions for the
ECEL, DDCC, and prescriptive controls, ancillary required
implementation measures, requirements for demonstrating compliance and
requirements for distributors, are described in more detail in Unit
IV.A.
c. Prescriptive Controls
Another requirement EPA considered to address unreasonable risk for
occupational conditions of use was requiring specific controls
prescribed by EPA, including engineering controls, administrative
controls, and/or PPE. In the 2020 Risk Evaluation for PCE, EPA
identified that certain workplace controls could reduce exposures. The
prescriptive controls EPA considered (such as respirators and gloves)
are based on information in the 2020 Risk Evaluation for PCE. In
general, prescriptive controls are not preferred as the primary method
of risk management because of uncertainties related to feasibility to
reduce exposures to address the unreasonable risk across all workplaces
engaged in a condition of use and whether the prescriptive controls
will be consistently or properly used. EPA understands that workplaces
have unique processes and equipment in place and that varying levels of
respiratory protection or dermal PPE may be needed for different
workplaces. Additionally, as described in Unit III.A.1. and 2., EPA
received input during required consultations and additional engagement
that options that align with the hierarchy of controls (i.e.,
elimination and substitution of hazards in the workplace) should be
preferred over prescriptive controls.
EPA determined that specific prescriptive controls (i.e., specific
engineering or administrative controls, or PPE) may not be able to
eliminate unreasonable risk for some conditions of use when used in
isolation. In the 2020 Risk Evaluation for PCE, analysis of
occupational exposure scenarios (OES) indicated that many conditions of
use still posed risk concerns even with the application of respirators
with APF 25 or 50 (Ref. 1). Because of the uncertainty regarding the
feasibility of exposure reductions through engineering controls alone,
EPA determined that a PCE WCPP ECEL, which would be accompanied by
monitoring requirements in tandem with the implementation of
engineering controls, administrative controls, and/or PPE as elements
of the program, as appropriate, would more successfully reduce exposure
so that the unreasonable risk is addressed. Additionally, relying
primarily on respirators and gloves to reduce exposures does not
consider other more protective controls in the hierarchy, including
elimination, substitution, engineering controls, and administrative
controls. For occupational conditions of use where compliance with the
PCE WCPP ECEL and DDCC is unlikely to be successful, in most cases
prohibitions (rather than prescribed controls) would be more
appropriate to ensure that PCE does not present unreasonable risk under
the conditions of use.
However, based on the 2020 Risk Evaluation for PCE, EPA considered
the industrial and commercial use in laboratory chemicals as a strong
candidate for prescriptive controls. While inhalation exposures from
the industrial and commercial use of PCE as a laboratory chemical did
not drive the unreasonable risk determination for PCE, EPA's risk
estimates were predicated on its finding that expected safety practices
of using PCE in small amounts under a fume hood reduce the potential
for inhalation exposures in laboratory settings. To codify assumptions
made in the 2020 Risk Evaluation for PCE regarding the use of fume
hoods in laboratory settings, EPA is proposing to require fume hoods in
laboratory settings that use PCE. This proposed requirement would
protect potentially exposed persons in laboratory settings by ensuring
that good laboratory practices that reduce the potential for inhalation
exposures are consistently applied. Additionally, the 2020 Risk
Evaluation for PCE determined that dermal exposures from the industrial
and commercial use of PCE as a laboratory chemical drive the
unreasonable risk determination for PCE, and analysis in the 2020 Risk
Evaluation for PCE indicated that there would still be risk concerns
even if chemically resistant gloves are used in combination with
specific activity training for tasks where dermal exposure can be
expected to occur. However, as described earlier, the 2020 Risk
Evaluation for PCE identifies several uncertainties regarding the use
of the dermal exposures modeled. For example, the 2020 Risk Evaluation
for PCE does not consider the frequency, type, and effectiveness of
gloves or other types of PPE used in laboratory settings. In
consideration of the whole of the 2020 Risk Evaluation for PCE,
including these uncertainties, EPA has preliminarily determined that
preventing direct dermal contact with PCE through dermal PPE which
covers any exposed skin and PPE training for the industrial and
commercial use in laboratory chemicals would address the unreasonable
risk from dermal exposure driven by this condition of use for
potentially exposed persons. EPA is requesting comment on whether
preventing dermal contact with PCE through dermal PPE and training
would adequately address the unreasonable risk from dermal exposures
for the industrial and commercial use in laboratory chemicals.
Additionally, most laboratories are regulated by OSHA under 29 CFR
1910.1450 requirements for occupational exposure to hazardous chemicals
in laboratories, and therefore may be more conducive to the
implementation of engineering controls such as fume hoods to evacuate
vapors and to the proper use and implementation of a dermal PPE program
to adequately reduce overall exposure to PCE. The industrial and
commercial use of PCE as a laboratory chemical would be necessary to
provide for the analysis of monitoring samples required under the ECEL
under this proposed regulation.
For certain occupational conditions of use, prescribed engineering
controls, administrative controls, and PPE were considered as part of
the alternative regulatory action and are described in more detail
later in this unit and in Unit IV.B.
2. Alternative Regulatory Actions
EPA acknowledges that, for some of the occupational conditions of
use that it is proposing to prohibit, there may be some activities or
facilities that could conceivably implement requirements under a PCE
WCPP to ensure that exposure remain below an ECEL and prevent direct
dermal contact with PCE. In some cases, they may be able to undertake
more extensive risk reduction measures than EPA currently anticipates.
Therefore, as a primary alternative regulatory action, described in
Unit IV.B., EPA is considering and requesting comment on a PCE WCPP--
including requirements to ensure exposures remain below an ECEL and
prevent direct dermal contact--for some conditions of use of PCE that
would be prohibited under the proposed regulatory action. For those
conditions of use that would be subject to the PCE WCPP under the
primary alternative regulatory action, but not the proposed
[[Page 39697]]
regulatory action, EPA was not able to identify reasonably available
information such as monitoring data or detailed activity descriptions
to indicate with certainty that relevant regulated entities for these
conditions of use could mitigate identified unreasonable risk through a
PCE WCPP. Due to this uncertainty, EPA is requesting comment on the
primary alternative regulatory action and in particular the likelihood
of successful compliance with a PCE WCPP, as described in Unit IV.A.,
for the conditions of use listed for the primary alternative regulatory
action of PCE WCPP in Unit IV.B.
EPA understands that some of the workplaces engaged in a condition
of use may already have stringent engineering controls, administrative
controls, and PPE in place to reduce inhalation and dermal exposures to
PCE. As part of the alternative regulatory action, EPA considered
prescribed engineering controls, administrative controls, and PPE for
some occupational conditions of use. In contrast to the proposed non-
prescriptive requirements of the WCPP where regulated entities would
have flexibility to select controls in accordance with the hierarchy of
controls to comply, EPA understands that requiring specific
prescriptive controls for certain occupational conditions of use may
provide greater certainty to some facilities that they are addressing
the unreasonable risk. However, as summarized in this unit, EPA has
uncertainty regarding the feasibility of exposure reductions through
specified engineering controls, administrative controls, and/or PPE to
address unreasonable risk across all workplaces engaged in certain
conditions of use. Prescribing specific engineering controls,
administrative controls, or PPE does not consider distinctions in
processes, equipment, or workplace layout in all facilities, which may
result in varying levels and types of controls needed to reduce
inhalation exposures to below the ECEL or to eliminate direct dermal
contact. Additionally, as described in Unit V.A.1.b., there is a degree
of uncertainty regarding applicability of respirators, including their
feasibility and consistency of proper use, especially when exposure
monitoring is not regularly conducted. However, as part of the primary
alternative regulatory action, EPA is considering PPE and soliciting
comment on prescribing specific engineering and administrative controls
for some occupational conditions of use. In the 2020 Risk Evaluation
for PCE, EPA identified PPE that could reduce exposures and is
therefore considering requiring PPE, including respiratory protection
and dermal protection, as part of the primary alternative regulatory
action for those conditions of use where the proposed regulatory action
is a PCE WCPP. Turning to the use of PPE, however, does not consider
other more preferable controls in the hierarchy of controls, including
elimination, substitution, engineering, and administrative controls. As
part of the primary alternative regulatory action, EPA is soliciting
comment on prescribing specific engineering or administrative controls
that would reduce inhalation and dermal exposures enough to address the
unreasonable risk across all workplaces engaged in a condition of use.
While the use of dermal PPE is typical for the use of PCE as a
laboratory chemical, EPA recognizes the potential for there to be other
exposure controls that could prevent direct dermal contact in a
laboratory setting. Therefore, as part of the primary alternative
regulatory action, EPA is considering implementation of DDCC as part of
a PCE WCPP for the industrial and commercial use of PCE as a laboratory
chemical. Similarly, EPA understands there may be exposure controls
other than a fume hood that could reduce inhalation exposures in a
laboratory setting and is therefore considering an ECEL as part of a
PCE WCPP for the industrial and commercial use of PCE as a laboratory
chemical.
EPA also considered proposing a TSCA section 6(g) time-limited
exemption for conditions of use that are critical to national security
and infrastructure. Based on reasonably available information, and as
described earlier in Unit IV.B.2.b, EPA has analyzed the need for an
exemption and has found that a TSCA section 6(g) exemption may be
warranted under the second alternative regulatory action for the
industrial and commercial use in maskant for chemical milling and for
the industrial and commercial use in vapor degreasing if the workplaces
engaged in that condition of use cannot meet the requirements of the
proposed regulatory action (PCE WCPP) or primary alternative regulatory
action (prescriptive controls) such that those conditions of use would
no longer drive the unreasonable risk. A section 6(g) exemption may
mean that the unreasonable risk will not be fully addressed. Note that
EPA's second alternative regulatory action endeavors to ensure that
worker protections are in place to the extent practicable and that EPA
is required to have a time limited requirement for any exemptions
granted under TSCA section 6(g), necessitating revisiting the need and
justification for any exemption beyond the initial timeframe.
Details of the primary alternative regulatory action and second
alternative regulatory action are described in more detail in Unit
IV.B.
3. Risk Management Requirements Considered but not Proposed
Since it is unlikely that all industrial or commercial facilities
with occupational exposures to PCE would be able to implement a WCPP or
prescriptive controls, EPA also examined the extent to which a point-
of-sale self-certification requirement in order to purchase and
subsequently use PCE would further ensure that only facilities able to
implement and comply with a WCPP or prescriptive controls are able to
purchase and use PCE, and self-certify to that. Under a self-
certification requirement, entities would submit a self-certification
to the distributor or retailer each time PCE is purchased. The self-
certification would consist of a statement indicating that the facility
is implementing a WCPP or required prescriptive controls to control
exposures to PCE; the self-certification would be signed and presented
by a person authorized to do so by the facility owner or operator.
Copies of the self-certification would be maintained as records by both
the owner or operator and the distributor or retailer where PCE was
purchased. However, because of the number and types of entities where
users can obtain PCE or PCE-containing products, EPA does not believe
the added requirement and subsequent burden of a point-of-sale self-
certification requirement for the use of PCE would be an effective tool
for preventing facilities that may be unable to comply with the WCPP or
prescriptive controls of this proposed rulemaking from accessing PCE or
PCE-containing products. As such, EPA is not proposing a self-
certification requirement as an additional component of the
requirements for addressing the unreasonable risk of occupational
exposures to PCE. However, EPA is requesting comment on whether to
include a self-certification requirement for purchasing PCE or PCE-
containing products. For example, EPA is interested in learning if, for
distributors and retailers, such a self-certification requirement would
provide greater certainty that any sale of PCE or PCE-containing
products would be for uses that are not prohibited and are to a
facility implementing the WCPP or required prescriptive controls.
[[Page 39698]]
Also, although NIOSH recognizes PCE as an eye irritant (Ref. 67),
EPA is not proposing requirements for eye protection from PCE, because
eye irritation or injury is not a component of the unreasonable risk
EPA has determined is presented by PCE.
In considering prescriptive controls as a regulatory action
described in this unit to address the unreasonable risk driven by dry
cleaning conditions of use, EPA examined monitoring data from New York
State Department of Environmental Conservation (NYSDEC) inspections
reports for the years 2013-2015 submitted in July 2020 during the
public comment period for the draft 2020 Risk Evaluation for PCE.
Previously, EPA rated this information as unacceptable for use in the
final 2020 Risk Evaluation for PCE due to lack of critical metadata on
sample type and sample duration (Refs. 68, 69). However, during risk
management, stakeholders confirmed the missing metadata is short-term
duration area monitoring (Refs. 70, 71). EPA analyzed the data to help
identify how certain controls may show reductions of PCE concentration
in ambient air in air monitoring data and reduce risk from inhalation
exposures for PCE dry cleaning (Ref. 45). The analysis of the data show
that while certain engineering controls such as 4th generation machines
and a vapor barrier room result in lower air concentration of PCE based
on area monitoring results, the overall statistics of the data show
that PCE air concentrations are generally in exceedance of the ECEL of
0.14 ppm as an 8-hour TWA. It should be noted that there are
limitations and uncertainties in using area monitoring data to estimate
worker exposure. Based on the results of this analysis and the
uncertainties of the data, EPA reasoned that prescriptive engineering
controls of requiring 4th generation machines or requiring a vapor
barrier room do not adequately address the unreasonable risk driven by
inhalation exposures to workers from the industrial and commercial uses
of PCE in dry cleaning. An industry stakeholder submitted additional
NYSDEC inspection reports for the years 2018-2019 in November 2021. EPA
considered the NYSDEC 2018-2019 inspection reports in the Economic
Analysis to estimate the age of dry cleaning machines and how much PCE
each machine typically uses in a year (Ref. 3).
In place of other regulatory actions, EPA considered limiting the
weight fraction of PCE in products and formulations to address the
unreasonable risk. As described in Unit V.A.1.a., EPA determined that
the unreasonable risk from PCE would not be driven by use of products
containing PCE at less than 0.1% by weight. Therefore, EPA is proposing
a de minimis level for products containing PCE at levels of less than
0.1% to account for impurities that do not drive the unreasonable
risk., as described in Unit IV.A.1.d. However, for most industrial/
commercial and consumer conditions of use, the concentration limit of
less than 0.1% is so low that it is highly unlikely that PCE would
still serve its functional purpose in the product or formulation. EPA
thus concluded that a weight fraction would essentially function as a
prohibition for most industrial/commercial and consumer conditions of
use. EPA therefore did not propose a weight fraction for industrial/
commercial and consumer conditions of use. For the industrial and
commercial use in solvent-based adhesives and sealants, EPA identified
several products available on the market at concentrations of PCE
between 0.1% and 1% by weight (Ref. 1). As part of the primary
alternative regulatory action, EPA would set a concentration limit of
PCE in adhesive and sealant products for industrial and commercial use
to 1%, as described in Unit IV.B.1.c.
4. Additional Considerations
After considering the different regulatory options under TSCA
section 6(a), alternatives (described in Unit V.B.), compliance dates,
and other requirements under TSCA section 6(c), EPA developed the
proposed regulatory action described in Unit IV.A. to address the
unreasonable risk from PCE to the extent necessary. To ensure
successful implementation of this proposed regulatory action, EPA
considered other requirements to support compliance with the proposed
regulations, such as requiring monitoring and recordkeeping to
demonstrate compliance with the PCE WCPP and downstream notification
regarding the prohibition on manufacturing, processing, distribution in
commerce, and use of PCE, including products containing PCE. These
proposed requirements are described in Unit IV.A.
As required under TSCA section 6(d), any rule under TSCA section
6(a) must specify mandatory compliance dates, which shall be as soon as
practicable with a reasonable transition period, but no later than 5
years after the date of promulgation of the rule (except in the case of
a use exempted under TSCA section 6(g) or for full implementation of
ban or phaseout requirements). These compliance dates are detailed in
Unit IV.A. and IV.B. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.
Following Panel recommendations in the SBAR report, and described in
Unit IV., EPA considered reasonable compliance timeframes in response
to SER input and other appropriate factors, such as the average
projected useful lifespan of dry cleaning machines, capital costs for
new equipment, and ongoing regulations and rulemakings, including the
proposed amendments to the PCE dry cleaning NESHAP (January 5, 2022; 87
FR 421) (Ref. 33). Additionally, following Panel recommendations in the
SBAR report, EPA considered compliance timelines based on the
availability of technically and economically feasible alternatives, as
well as any information provided by other agencies that set
requirements for certification or standards relevant to degreasing,
parts cleaning, or other uses of PCE. Following Panel recommendations
in the SBAR report, EPA is requesting comment on any additional
appropriate factors for identifying reasonable compliance timeframes
and how to weigh the factors for dry cleaning and other industries, as
well as differing compliance or reporting requirements or timetables
that account for the resources available to small entities.
B. Consideration of Alternatives in Deciding Whether To Prohibit or
Substantially Restrict PCE
Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or
restrict in a manner that substantially prevents a specific condition
of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must consider, to
the extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other
restriction takes effect. To that end, in addition to an Economic
Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using
reasonably available information (Ref. 56).
For this assessment, EPA identified and analyzed alternatives to
PCE in products relevant to industrial, commercial, and consumer
conditions of use proposed to be prohibited or restricted, even if such
restrictions are not anticipated to substantially prevent the condition
of use. Based on reasonably available information,
[[Page 39699]]
including information submitted by industry, EPA understands viable
alternatives to PCE may not be available for several conditions of
use--for example, the industrial and commercial use in maskant for
chemical milling and for the industrial and commercial use in vapor
degreasing for certain applications (Refs. 54, 57, 58)--and considered
that information to the extent practicable in the development of the
regulatory options as described in Unit III.B.3. For some conditions of
use, EPA was unable to identify products currently available for sale
that contain PCE. EPA is soliciting comments on whether there are
products in use or available for sale relevant to these conditions of
use that contain PCE at this time, so that EPA can ascertain whether
there are alternatives that benefit human health or the environment as
compared to such use of PCE. These conditions of use are detailed in
the Alternatives Assessment (Ref. 56).
For conditions of use for which products currently containing PCE
were identified, EPA identified several hundred commercially available
alternative products that do not contain PCE, and listed in the
Alternatives Assessment, to the extent practicable, their unique
chemical components, or ingredients. For each of these chemical
components or ingredients, EPA identified whether it functionally
replaced PCE for the product use and screened product ingredients for
human health and environmental hazard, as well as identified
flammability and global warming potential where information was
reasonably available (Ref. 56). EPA then assigned a rating to the human
health and environmental hazards, using a methodology described in the
Alternatives Assessment document. In general, EPA identified products
containing ingredients with a lower hazard screening rating than PCE
for certain endpoints, while some ingredients presented higher hazard
screening ratings than PCE (Ref. 56). These alternative hazard
screening ratings are described in detail in the Alternatives Analysis
grouped under common product use categories (Ref. 56). Additionally,
based on input provided by SERs during the SBAR Panel, EPA understands
that some available alternatives may present problems for certain
users. For example, SERs identified concerns with water-based
alternatives such as potential termite and mold damage to wood in
buildings or water supply limitations due to a drought. SERs also
identified concerns with alcohol-based alternatives that present a fire
risk, and which may require users to acquire certain permits or comply
with restrictions set by State and local agencies, including fire
departments. Information regarding potential problems with available
alternatives as indicated by SERs during the SBAR Panel is outlined in
the SBAR Panel Report (Ref. 33). Following Panel recommendations in the
SBAR report, EPA requests public comment about the feasibility of use
of alternatives to PCE and their availability for conditions of use
that drive the unreasonable risk.
In deciding whether to propose prohibition or other significant
restrictions on a condition of use of PCE and in proposing an
appropriate transition period for any such action, EPA has therefore,
pursuant to TSCA section 6(c)(2)(C), considered, to the extent
practicable, whether technically and economically feasible alternatives
that benefit human health or the environment, compared to the use
proposed to be prohibited or restricted, would be reasonably available
as a substitute when a proposed prohibition or other significant
restriction would become effective. EPA is additionally requesting
comment on the Alternatives Assessment as a whole.
VI. TSCA Section 6(c)(2) Considerations
A. Health Effects of PCE and the Magnitude of Human Exposure to PCE
EPA's analysis of the health effects of PCE and the magnitude of
human exposure to PCE are in the 2020 Risk Evaluation for PCE (Ref. 1).
A summary is presented here.
The 2020 Risk Evaluation for PCE identified potential health
effects of PCE including non-cancer adverse health effects such as
neurotoxicity and central nervous system effects, kidney and liver
effects, immune system toxicity, reproductive toxicity, and
developmental toxicity and cancer hazards from carcinogenicity as well
as genotoxicity.
Among the non-cancer adverse health effects, EPA identified visual
deficits indicative of neurotoxicity as a primary effect of PCE in
humans following acute and chronic inhalation and dermal exposures.
Identified symptoms of neurotoxicity include color confusion, changes
in visual contrast detection, and alteration of visual-spatial
function. Impaired visual and cognitive function and diminished color
discrimination are the most sensitive adverse effects driving the
unreasonable risk of PCE exposure. Additionally, the 2020 Risk
Evaluation for PCE identified that PCE exposure is associated with
several types of cancer, including liver tumors, brain gliomas, kidney
cancer, and testicular cancer. By the criteria presented in EPA's
Guidelines for Carcinogen Risk Assessment (Ref. 41), PCE is
characterized as ``likely to be carcinogenic to humans by all routes of
exposure'' based on conclusive evidence in mice and rats and suggestive
evidence in humans.
Other adverse health effects identified in the 2020 Risk Evaluation
for PCE identified include central nervous system depression, kidney
nephrotoxicity and proximal tubule nuclear enlargement, liver necrosis
and extreme dilation of blood or lymph vessels, reduced sperm quality,
reduced red blood cells and hemoglobin, increased immune cells,
decreased fetal/placental weight, developmental neurotoxicity, and
skeletal effects from chronic exposures (Ref. 1).
Regarding the magnitude of human exposure, one factor EPA considers
for the conditions of use that drive unreasonable risk is the size of
the exposed population which, for PCE, EPA estimates is 67,675 workers
and 22,090 ONUs (Ref. 3). The number of consumers that use the
approximately 115 types of products containing PCE each year is
unknown.
For the conditions of use that drive the unreasonable risk for PCE,
PESS include workers, ONUs, consumer users, and bystanders to consumers
using products containing PCE. Children of workers present at dry
cleaners are also a PESS group exposed to PCE during industrial and
commercial use of PCE in dry cleaning and spot cleaning.
In addition to workers, ONUs, consumers, and bystanders to consumer
use directly exposed to PCE, EPA recognizes there is exposure to the
general population from air and water pathways for PCE. As mentioned in
Unit II.D., EPA has separately conducted a screening approach to assess
whether there may be potential risks to the general population from
these exposure pathways. While the use of this screening approach
indicates that EPA is not able to find that there are no potential
risks to fenceline communities, the screening approach was not designed
to facilitate the making of an unreasonable risk determination for
these communities. This unit summarizes the results of that fenceline
analysis. Although EPA is not making a determination of unreasonable
risk based on the fenceline screening analysis, the proposed regulatory
action described in Unit IV. is expected to reduce the risks identified
in the screening approach.
[[Page 39700]]
As described in Unit II.D., EPA's analysis methodology was
presented to the SACC peer review panel in March 2022, and EPA plans to
consider SACC feedback (including the SACC recommendation to EPA to
consider multiple years of release data to estimate exposures and
associated risks) and make decisions regarding how to assess general
population exposures in upcoming risk evaluations, such as for the 1,4-
dioxane supplement, the forthcoming 20 High Priority Substances, and
manufacturer-requested risk evaluations. For PCE, EPA recognizes that a
key input into the fenceline analysis for the ambient air pathway was
data on releases from the most recent Toxics Release Inventory (TRI)
reporting year and that the use of more than one year of data could
result in different conclusions. Accordingly, in this unit EPA presents
the results of its water pathway fenceline analysis based on PCE
releases to water and its ambient air pathway fenceline analysis based
on PCE releases reported to TRI over a single reporting year as well as
over multiple years (Refs. 72, 73).
EPA's fenceline analysis for the air pathway for PCE indicates that
EPA is not able to conclude that there are no potential risks to
fenceline communities, described further in this unit. Additionally,
based on the fenceline analysis for the ambient air pathway for PCE,
including the strengths, limitations, and uncertainties associated with
the information used to inform the analysis, EPA is unable to determine
with this analysis whether those risks drive the unreasonable risk of
injury to health presented by PCE. Standard cancer benchmarks used by
EPA and other regulatory agencies are an increased cancer risk above
benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 (i.e., 1 x
10-\6\ to 1 x 10-\4\) depending on the
subpopulation exposed (see, e.g., EPA's interpretation set forth in 54
FR 38044 (Sept. 14, 1989) which discusses the use of benchmarks for
purposes of Section 112 of the Clean Air Act (CAA); see also EPA's
interpretation of the upper bound of acceptable risk and the preferred
benchmark described in the Letter of Concern regarding EPA Complaint
Nos. 01R-22-R6, 02R-22-R6, and 04R-22 -R6 see page 3 footnotes 5 and 6
and page 6 (Ref. 74)). In this fenceline analysis for the ambient air
pathway for PCE, estimates of risk to fenceline communities were
calculated using 1 x 10-\6\ as the benchmark for cancer risk
in fenceline communities. While EPA is unable to determine, based on
the screening level fenceline analysis, whether risks to the general
population drive the unreasonable risk, as a matter of risk management
policy EPA considers the range of 1 x 10-\6\ to 1 x
10-\4\ as the appropriate benchmark for increased cancer
risk for the general population, including fenceline communities. It is
preferable to have the air concentration of PCE result in an increased
cancer risk closer to the 1 x 10-\6\ benchmark, with the 1 x
10-\4\ benchmark generally representing the upper bound of
acceptability for estimated excess cancer risk. The benchmark value is
not a bright line, and the Agency considers a number of factors when
determining unreasonable risk, such as the endpoint under
consideration, the reversibility of effect, and exposure-related
considerations (e.g., duration, magnitude, or frequency of exposure, or
population exposed).
In this unit, EPA presents the results of its ambient air pathway
fenceline analysis and the uncertainties associated with the analysis.
EPA also describes how the proposal to prohibit the manufacturing
(include importing), processing, and distribution in commerce of PCE
for most industrial and commercial use and all consumer use, and to
prohibit most industrial and commercial use of PCE, is expected to
reduce the potential risks identified in the screening analysis to any
general population or fenceline communities close to facilities
engaging in PCE use. This unit also describes how EPA believes the
proposed WCPP requirements may reduce exposures to the general
population for facilities identified in the fenceline analysis with
expected exposures to fenceline communities that are associated with
conditions of use EPA is not proposing to prohibit. EPA therefore does
not intend to revisit the air pathway for PCE as part of a supplemental
risk evaluation.
There are some uncertainties associated with the fenceline analysis
for the air pathway for PCE. The TRI dataset used for the single- and
the multi-year fenceline analysis and land use analysis does not
include actual release point locations which can affect the estimated
concentrations at varying distances modeled. To identify the release
location for each facility, EPA used a local-coordinate system based on
latitude/longitude coordinates reported in TRI. The latitude/longitude
coordinates may represent the mailing address location of the office
building associated with a very large facility or some other area of
the facility rather than the actual release location (e.g., a specific
process stack). This discrepancy between the coordinates reported in
TRI and the actual release point could result in an exposure
concentration that does not represent the actual distance where
fenceline communities may be exposed. The fenceline analysis also
evaluated the most ``conservative exposure scenario'' that consists of
a facility that operates year-round (365 days per year, 24 hours per
day, 7 days per week) in a South Coastal meteorologic region and a
rural topography setting (Ref. 73). Therefore, the modeled exposures to
receptors may be overestimated if there are fewer exposure days per
year or hours per day. Additionally, the ambient air fenceline analysis
organizes facilities and associated risks by OES and generally
crosswalks each OES with the associated condition of use of PCE (Ref.
73). For some OES, EPA identified the associated conditions of use to
the category level in the December 2020 Risk Evaluation for PCE but was
unable identify to the conditions of use to the subcategory level due
to limited information on activities and use of PCE reported under TRI.
Therefore, some OES indicating increased cancer risk from ambient air
exposures to PCE in the air fenceline analysis may be associated with
one or more conditions of use of PCE.
EPA's single year fenceline analysis for the ambient air pathway,
based on methods presented to the SACC, evaluated PCE releases reported
to TRI over the 2019 reporting year. This single year fenceline
analysis identified 65 facilities with some indication of releases and
potential exposure with associated cancer risk to receptors within
select distances evaluated from 5 to 1,000 meters from the respective
releasing facility. Separately, following SACC feedback, EPA applied a
slightly modified pre-screening methodology to evaluate 6 years of PCE
release data (2015 through 2020 TRI data as well as the 6-year average
of that data) rather than a single year of data for facilities with
reported releases in TRI. The multi-year fenceline analysis identified
30 facilities with some indication of releases and potential exposures
and associated cancer risk at a distance of 100 meters from the
releasing facility. Based on the multi-year fenceline analysis, 12 of
these 30 facilities either had risks above the benchmark for cancer at
distances farther out to 100 meters when compared to the single year
analysis or are facilities that were not captured in the single-year
analysis (e.g., did not report in 2019 TRI). Although the multi-year
analysis identified several additional facilities with risk estimates
above the benchmark for cancer farther out when
[[Page 39701]]
compared to the single year analysis or that were not captured in the
single-year analysis, the results of overall risk profiles (i.e., OES
and corresponding conditions of use with risk estimates above the
benchmark for cancer at the distances evaluated) for the single year
and multi-year fenceline analyses are the same. While the fenceline
analysis identified facilities with some indication of releases and
potential exposure with associated increased cancer risk that exceeds
the 1 x 10-\6\ benchmark at a distance of 100 meters from
the releasing facility, the analysis did not identify any facilities
exceeding the 1 x 10-\4\ benchmark; the highest risk
estimate is in the 1 x 10-\5\ range (Ref. 73).
EPA conducted a land use analysis to determine if EPA can
reasonably expect an exposure to fenceline communities to occur within
the modeled distances for facilities where there was an indication of
risk in the single year or multi-year fenceline analysis. This review
consisted of a visual analysis using aerial imagery and interpreting
land/use zoning practices around the facility to identify where
residential, industrial/commercial businesses, or other public spaces
are present within those radial distances indicating risk (as opposed
to uninhabited areas), as well as whether the radial distances lie
outside the boundaries of the facility. The land use analysis of the 65
facilities indicating risk in the single-year fenceline analysis
identified 24 facilities with expected exposure to fenceline
communities. The land use analysis of the 12 additional facilities
indicating risk in the multi-year fenceline analysis (i.e., facilities
where risk estimates were above the benchmark for cancer at distances
farther out when compared to the single-year analysis or facilities
that were not captured in the single year analysis) identified 5
additional facilities with expected exposure to fenceline communities.
Overall, the land use analysis identified a total of 29 facilities,
representing eight OES, with expected exposure to fenceline
communities. Those eight OES include: maskant for chemical milling;
incorporation into formulation, mixture, or reaction product;
industrial processing aid; metalworking fluids; other industrial uses--
textile processing; degreasing (batch open-top degreasing; batch
closed-loop degreasing; conveyorized vapor degreasing; web vapor
degreasing; cold cleaning); manufacturing; and processing as a reactant
(Ref. 73).
Under the proposed regulatory action described in Unit IV.A., all
of the conditions of use associated with the metalworking fluids and
other industrial uses--textile processing OES would be prohibited. EPA
is also proposing to prohibit the processing into formulation, mixture
or reaction product for other chemical products and preparations that
may be associated with the facilities for the incorporation into
formulation, mixture or reaction product OES; the industrial and
commercial use as a processing aid in pesticide, fertilizer and other
agricultural chemical manufacturing that may be associated with the
facilities for the processing aid OES; and the industrial and
commercial use as solvent for cold cleaning that may be associated with
the degreasing OES (batch open-top degreasing; batch closed-loop
degreasing; conveyorized vapor degreasing; web vapor degreasing; cold
cleaning). As a result, exposures to any fenceline communities from
these facilities would be addressed under the prohibitions in the
proposed rulemaking.
The remaining facilities with expected exposure to fenceline
communities may be associated with the following conditions of use that
EPA is not proposing to prohibit: manufacturing; processing as a
reactant/intermediate; processing into formulation, mixture or reaction
product for cleaning and degreasing products; processing into
formulation, mixture, or reaction product for paint and coating
products; processing into formulation, mixture, or reaction product for
adhesives and sealants; industrial and commercial use as solvent for
open-top batch vapor degreasing; industrial and commercial use as
solvent for closed-loop batch vapor degreasing; industrial and
commercial use as solvent for in-line conveyorized vapor degreasing;
industrial and commercial use as solvent for in-line web cleaner vapor
degreasing; industrial and commercial use in maskants for chemical
milling; and industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing. For these
conditions of use that may be associated with facilities that indicate
expected exposure to fenceline communities, the proposed rule would
require strict workplace exposure controls via implementation of a WCPP
as described in Unit IV.A.2. Under the proposed WCPP requirements,
facilities would need to monitor PCE air concentrations by taking
personal breathing zone air samples of potentially exposed persons,
which would allow facilities to better understand and manage the total
releases of PCE within the facility and potentially stack and fugitive
emissions. Furthermore, under the WCPP requirements, facilities would
need to evaluate controls to determine how to reduce releases and
exposures to potentially exposed persons in the workplace. EPA
anticipates that this analysis would help facilities to determine the
most effective ways to reduce exposures (including possible engineering
controls or elimination/substitution of PCE) and whether those methods
for exposure reduction impact releases, and therefore may reduce the
overall risk to fenceline communities. EPA requests comment on whether
owners and operators should be required to attest to whether and why
the exposure controls they have selected would not result in increased
air releases of PCE from the workplace, and keep records of that
statement as part of the WCPP exposure control plan.
Under the proposed rule, only 17 conditions of use would continue
(see Unit IV.C. for a summary). For many of these conditions of use,
EPA expects use to decline over time. For example, the manufacturing
and processing into formulation, mixture, or reaction product
conditions of use can reasonably be expected to decline because, while
manufacturing and processing into a formulation, mixture, or reaction
product could continue under a WCPP, downstream distribution and use of
formulations, mixtures, or reaction products other than for vapor
degreasing, chemical milling, adhesives and sealants, petrochemical
manufacturing, and laboratory use would be prohibited. Additionally,
EPA expects the industrial and commercial use of PCE as a reactant in
the generation of HFC-134a and HFC-125 to also 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. HFC-125 and
HFC-134a are two of the regulated substances that are subject to the
AIM Act phasedown.
For all 17 conditions of use that would remain ongoing, the
proposed rule would require strict workplace exposure controls via
implementation of a WCPP or prescriptive workplace controls for
laboratory use, as described in Unit IV.A.1. In the instances where
efforts to reduce exposures in the workplace to levels below the ECEL
could lead to adoption of engineering controls that ventilate more PCE
outside, EPA believes this potential exposure would be limited as a
result of the existing NESHAP for PCE for these conditions of use under
the CAA. Applicable NESHAP include: 40 CFR
[[Page 39702]]
part 63, subpart F, Synthetic Organic Chemical Manufacturing Industry;
40 CFR part 63, subpart DD, Off-Site Waste and Recovery Operations; 40
CFR part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part
63, subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part
63, subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR
part 63, subpart T, Halogenated Solvent Cleaning, which impose emission
standards and work practice requirements reflecting maximum achievable
control technologies and generally available control technologies. The
CAA required residual risk reviews for standards reflecting maximum
achievable control technologies, and technology reviews are required
every 8 years for all NESHAP.
EPA's fenceline analysis for the water pathway for PCE, based on
methods presented to the SACC, did not find risks from drinking water,
incidental oral ingestion of surface water, or incidental dermal
exposure to surface water (Ref. 72). EPA therefore does not intend to
revisit the water pathway for PCE as part of a supplemental risk
evaluation.
B. Environmental Effects of PCE and the Magnitude of Exposure of the
Environment to PCE
EPA's analysis of the environmental effects of PCE and the
magnitude of exposure of the environment to PCE are in the 2020 Risk
Evaluation for PCE (Ref. 1). The unreasonable risk determination for
PCE is based solely on risks to human health; based on the TSCA 2020
Risk Evaluation for PCE, EPA determined that exposures to the
environment did not drive the unreasonable risk. A summary is presented
here.
The manufacturing, processing, use, and disposal of PCE can result
in releases to the environment, including aquatic releases of PCE from
facilities that manufacture, use, or process PCE. Fate, exposure, and
environmental hazard were evaluated in the 2020 Risk Evaluation for PCE
in order to characterize environmental risk of PCE. PCE has low
bioaccumulation potential and moderate potential to accumulate in
wastewater biosolids, soil, or sediment. Releases of PCE to the
environment are likely to volatilize to the atmosphere, where it will
slowly photooxidize. It may migrate to groundwater, where it will
slowly hydrolyze. Additionally, the bioconcentration potential of PCE
is low.
Potential effects of PCE exposure described in the literature for
aquatic life include mortality, developmental deformities,
immobilization, reproductive effects, growth effects, and biomass
effects. EPA concluded that PCE poses a hazard to environmental aquatic
organisms, including aquatic invertebrates, fish, amphibians, and
aquatic plants (algae). For acute exposures, PCE is a hazard to aquatic
invertebrates based on immobilization, to fish based on immobilization
of midge larvae at 7.0 mg/L, to fish based on mortality of rainbow
trout as the most sensitive species with acute toxicity values as low
as 4.8 mg/L, and amphibians based on developmental effects to the wood
frog as the most sensitive species with acute toxicity values as low as
7.8 mg/L. For chronic exposures, PCE is a hazard to aquatic
invertebrates, with a toxicity value of 0.5 mg/L; and a chronic
toxicity value of 0.84 mg/L for fish. PCE is also a hazard for green
algae with a toxicity value of 3.6 mg/L. EPA incorporated modeled
exposure data from the Exposure and Fate Assessment Screening Tool or
E-FAST (Ref. 75), as well as monitored data from the Water Quality
Portal (Ref. 76), to characterize the exposure of PCE to aquatic
species.
In the 2020 Risk Evaluation for PCE, the indicators evaluated for
risk of injury to the environment include immobilization from acute
exposure, growth effects from chronic exposure, and mortality to algae
(Ref. 1). Based on the 2020 Risk Evaluation for PCE, EPA did not
identify risk of injury to the environment that drive the unreasonable
risk determination for PCE.
C. Benefits of PCE for Various Uses
PCE is a solvent used in a variety of industrial, commercial, and
consumer use applications, including as a feedstock in the production
of fluorinated compounds, cleaning and degreasing, adhesives and
sealants, paints and coatings, lubricants and greases, processing aid,
and other uses. The physical and chemical properties of PCE, such as
non-flammability, high volatility, low global warming potential, low
vapor pressure, high chloride density, high boiling point, and high
solvency of oils, waxes, and greases, as well as relatively low cost,
make it a popular and effective solvent for many applications (Refs. 1,
77, 78).
The largest uses of PCE, by production volume, are processing as a
reactant and as a solvent in dry cleaning and vapor degreasing (Ref.
1). Based on the 2020 Risk Evaluation for PCE, nearly 65% of the
production volume of PCE is used as an intermediate in industrial gas
manufacturing and producing fluorinated compounds. The leading
fluorocarbons being produced from PCE are HFC-134a and HFC-125,
although a small amount of PCE may be used in the production of CFC-113
for applications vital to U.S. security exempted under Title VI of the
Clean Air Act Amendments of 1990 (40 CFR part 82), HCFC-123, and HCFC-
124. The second largest use of PCE is as a solvent in dry cleaning
facilities. PCE effectively dissolves fats, greases, waxes and oils,
without harming natural or human-made fibers. However, there appears to
be a trend towards alternatives to PCE in dry cleaning and the demand
for PCE dry cleaning solvents has steadily declined as a result of the
improved efficiency of dry cleaning equipment, increased chemical
recycling and the popularity of wash-and-wear fabrics that eliminate
the need for dry cleaning (Refs. 79, 1). According to the 2020 Risk
Evaluation for PCE, the third largest use of PCE is as a vapor
degreasing solvent. PCE can be used to dissolve many organic compounds,
select inorganic compounds and high-boiling waxes and resins, making it
useful for cleaning contaminated metal parts and other fabricated
materials (Ref. 79). Based on market research, EPA understands that use
of PCE as a vapor degreasing solvent has declined and estimates there
are 88 facilities that use PCE for vapor degreasing nationwide (Ref.
3).
PCE has many other uses, which, based on the 2020 Risk Evaluation
for PCE, collectively constitute about 10% of the production volume
(Ref. 1). In petrochemical manufacturing, PCE is used as a chloriding
agent for reforming and isomerization catalyst process units, which
account for approximately 45% of the gasoline pool in the United States
(Refs. 66, 63). The high chloride density of PCE minimizes the amount
of chemical needed for catalyst regeneration compared to other
chloriding agents and the non-flammability is important for process
considerations. PCE is also used in maskant for chemical milling,
plating, and anodizing processes in the aerospace (military,
commercial, and space) and non-aerospace military industries (Ref. 1),
as well as in a mission-critical elastomer adhesive used in human-rated
rocket motor assembly (including rocket motor subsystem components such
as the rocket motor nozzle assembly) (Ref. 59).
[[Page 39703]]
D. Reasonably Ascertainable Economic Consequences of the Proposed Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
The reasonably ascertainable economic consequences of this proposed
rule include several components, all of which are described in the
Economic Analysis for this proposed rule (Ref. 3). With respect to the
anticipated effects of this proposed rule on the national economy, EPA
considered the number of businesses and workers that would be affected
and the costs and benefits to those businesses and workers and did not
find that there would be an impact on the national economy (Ref. 3).
The economic impact of a regulation on the national economy becomes
measurable only if the economic impact of the regulation reaches 0.25%
to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is
equivalent to a cost of $40 billion to $80 billion. Therefore, because
EPA has estimated that the monetized cost of the proposed rule would
range from $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, EPA
has concluded that this rulemaking is highly unlikely to have any
measurable effect on the national economy (Ref. 3). In addition, EPA
considered the employment impacts of this proposed rule, and found that
the direction of change in employment is uncertain, but EPA expects the
short-term and longer-term employment effects to be small.
There are an estimated 12,202 small entities affected by the
proposed option with a per firm and total estimated cost impact of $850
and $10.4 million, respectively. Of the small businesses potentially
impacted by this proposed rule, over 99% are expected to have impacts
of less than 1% to their firm revenues, 0.1% are expected to have
impacts between 1 and 3% to their firm revenues, and 0.2% are expected
to have impacts greater than 3% to their firm revenues. EPA estimates
that there are currently 6,000 firms currently using PCE dry cleaning
machines, but estimates that only 62 would still be using PCE for dry
cleaning by the end of the proposed 10-year phaseout. As described
further in the Economic Analysis, EPA believes that almost no new PCE
machines have been brought into service in recent years and therefore
most existing dry cleaning machines using PCE are old and will no
longer be in service by the proposed phaseout date. Based on the
estimated revenues per firm presented in Table 3-1 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. EPA requests comment on these estimated impacts to
the dry cleaning industry, including regarding expected closures. In
addition to dry cleaners, additional users of PCE (such as in vapor
degreasing) could be strongly impacted because they may have no
economical alternative to the use of PCE.
With respect to this proposed rule's effect on technological
innovation, EPA expects this rulemaking to spur more innovation than it
will hinder. A prohibition or significant restriction on the
manufacture, processing, and distribution in commerce of PCE for uses
covered in this proposed rule may increase demand for safer chemical
substitutes. This proposed rule is not likely to have significant
effects on the environment because PCE does not present an unreasonable
risk to the environment, though this proposed rule does present the
potential for small reductions in air emissions and soil contamination
associated with improper disposal of products containing PCE. The
effects of this proposed rule on public health are estimated to be
positive, due to the reduced risk of cancer and other non-cancer
endpoints from exposure to PCE.
2. Costs and Benefits of the Proposed Regulatory Action and of the One
or More Primary Alternative Regulatory Actions Considered by the
Administrator
The costs and benefits that can be monetized for this proposed rule
are described at length in in the Economic Analysis (Ref. 3). The
monetized costs for this proposed rule are estimated to range from
$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. The monetized
benefits are estimated to be $10.2 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. Costs do not include
possible additional costs from prohibition of all uses of PCE (except
for petrochemical processing) due to need to switch processes or
chemicals. EPA requests comment on costs that may be incurred by firms
using PCE products to identify suitable alternatives, test them for
their desired applications, learn how to use them safely and
effectively, and implement new processes for using the alternative
products.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary and second alternative regulatory actions are described in
detail in Unit IV.B. The estimated annualized costs of the primary
alternative regulatory action are $14.5 million at a 3% discount rate
and $14.7 million at a 7% discount rate over 20 years (Ref. 3). The
estimated annualized costs of the second alternative regulatory action
are $17.8 million at a 3% discount rate and $19.5 million at a 7%
discount rate over 20 years. The monetized benefits of the primary
alternative action are estimated to be $10.2 to $46.2 million
annualized over 20 years at a 3% discount rate and $4.71 million to
$29.3 million annualized over 20 years at a 7% discount rate (Ref. 3).
The monetized benefits of the second alternative action are estimated
to be $10.2 to $46.4 million annualized over 20 years at a 3% discount
rate and $4.73 million to $29.4 million annualized over 20 years at a
7% discount rate. Costs of the second alternative action do not include
possible additional costs from prohibition of non-petrochemical
processing and chemical milling uses of PCE. These costs for chemical
milling could be significant as there is no alternative to the use of
PCE in chemical milling for many users. For vapor degreasing, as
described in the Economic Analysis, EPA assumes that
[[Page 39704]]
there are alternatives to PCE for all users, although switching to some
of these alternatives may be very expensive due to required
revalidation and possible equipment changes. At least one user has told
EPA that they have no alternative to the use of PCE in closed-loop
vapor degreasing and at least one other user has requested a 10-year
phaseout for the use of PCE in vapor degreasing due to the needs for
revalidation and possible equipment changes throughout the supply chain
(Ref. 3).
This proposal is expected to achieve health benefits for the
American public, some of which can be monetized and others that, while
tangible and significant, cannot be monetized. EPA believes that the
balance of costs and benefits of this proposal cannot be fairly
described without considering the additional, non-monetized benefits of
mitigating the non-cancer adverse effects. These effects may include
neurotoxicity, kidney toxicity, liver toxicity, immunological and
hematological effects, reproductive effects, and developmental effects.
The multitude of adverse effects from PCE exposure can profoundly
impact an individual's quality of life, as discussed in Unit II.A.
(overview), III.B.2. (description of the unreasonable risk), VI.A.
(discussion of the health effects), and the 2020 Risk Evaluation for
PCE. Chronic adverse effects of PCE exposure include both cancer and
the non-cancer effects listed above. Acute effects of PCE exposure
could be experienced for a shorter portion of life but are nevertheless
significant in nature. The incremental improvements in health outcomes
achieved by given reductions in exposure cannot be quantified for non-
cancer health effects associated with PCE exposure, and therefore
cannot be converted into monetized benefits. The qualitative discussion
throughout this rulemaking and in the Economic Analysis highlights the
importance of these non-cancer effects. These effects include
willingness-to-pay to avoid illness, which includes cost of illness and
other personal costs such as pain and suffering. Considering only
monetized benefits underestimates the impacts of PCE adverse outcomes
and therefore underestimates the benefits of this proposed rule.
3. Cost Effectiveness of the Proposed Regulatory Action and of the 1 or
More Primary Alternative Regulatory Actions Considered by the
Administrator
Cost effectiveness is a method of comparing certain actions in
terms of the expense per item of interest or goal. A goal of this
proposed regulatory action is to prevent unreasonable risk resulting
from exposure to PCE. The proposed regulatory action would cost $3.0
million per potential prevented cancer case while the primary
alternative regulatory action would cost $3.1 million (using the 3%
discount rate) and the second alternative regulatory action would cost
$3.8 million to achieve the same goals. At a 7% discount rate, the
proposed regulatory action would cost $3.0 million per potential
prevented cancer case while the primary alternative regulatory action
would cost $3.1 million, and the second alternative regulatory action
would cost $4.2 million to achieve the same goals. While the proposed
regulatory action is lower in cost compared to the other alternative
actions, the difference is small (Ref. 3).
VII. TSCA Section 9 Analysis, Section 14, and Section 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. Section 9(a) describes
additional procedures and requirements to be followed by EPA and the
other Federal agency following submission of any such report. As
discussed in this unit, for this proposed rule, the Administrator
proposes to exercise his discretion not to determine that the
unreasonable risk from PCE under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA.
In addition, TSCA section 9(d) instructs the Administrator to
consult and coordinate TSCA activities with other Federal agencies for
the purpose of achieving the maximum enforcement of TSCA while imposing
the least burdens of duplicative requirements. For this proposed rule,
EPA has and continues to coordinate with appropriate Federal executive
departments and agencies, including OSHA and the Consumer Product
Safety Commission (CPSC), to, among other things, identify their
respective authorities, jurisdictions, and existing laws with regard to
PCE, which are summarized in this unit.
OSHA requires that employers provide safe and healthful working
conditions by setting and enforcing standards and by providing
training, outreach, education and assistance. As described in Unit
II.C., OSHA, in 1971, established a PEL for PCE of 100 ppm of air as an
8-hour TWA with an acceptable ceiling concentration of 200 ppm and an
acceptable maximum peak above the acceptable ceiling concentration for
an eight-hour shift of 300 ppm, maximum duration of 5 minutes in any 3
hours. However, the exposure limits established by OSHA are higher than
the exposure limit that EPA determined would be sufficient to address
the unreasonable risk identified under TSCA from occupational
inhalation exposures associated with certain conditions of use. Gaps
exist between OSHA's authority to set workplace standards under the OSH
Act and EPA's obligations under TSCA section 6 to eliminate
unreasonable risk presented by chemical substances under the conditions
of use. Health standards issued under section 6(b)(5) of the OSH Act
must reduce significant risk only ``to the extent feasible.'' 29 U.S.C.
655(b)(5). To set PELs for chemical exposure, OSHA must first establish
that the new standards are economically and technologically feasible
(79 FR 61384, 61387, Oct. 10, 2014). But under TSCA section 6(a), EPA's
substantive burden is to demonstrate that, as regulated, the chemical
substance no longer presents an unreasonable risk, with unreasonable
risk being determined without consideration of costs or other nonrisk
factors. Thus, if OSHA were to initiate a new action to lower its PEL,
the difference in standards between the OSH Act and TSCA may well
result in the OSHA PEL being set at a higher level than the exposure
limit that EPA determined would be sufficient to address the
unreasonable risk under TSCA.
In addition, OSHA may set exposure limits for workers, but its
authority is limited to the workplace and does not extend to consumer
uses of hazardous chemicals, and thus OSHA cannot address the
unreasonable risk from PCE under all of its conditions of use, which
include consumer uses. OSHA also does not have direct authority over
State and local employees, and it has no authority over the working
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
CPSC, under authority provided to it by Congress in the CPSA,
protects the public from unreasonable risk of injury or death
associated with the use of consumer products. Under the CSPA, CPSC has
the authority to regulate PCE in consumer products, but not in other
sectors such as automobiles, industrial
[[Page 39705]]
and commercial products, or aircraft, for example. Further, a consumer
product safety rule under the CPSA must include a finding that ``the
benefits expected from the rule bear a reasonable relationship to its
costs,'' 15 U.S.C. 2058(f)(3)(E), whereas EPA must apply TSCA risk
management requirements to the extent necessary so that the chemical no
longer presents unreasonable risk and only consider costs and benefits
of the regulatory action to the extent practicable, 15 U.S.C. 2605(a),
(c)(2). Additionally, the 2016 amendments to TSCA reflect Congressional
intent to ``delete the paralyzing `least burdensome' requirement,'' 162
Cong. Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as
originally enacted, which required EPA to use ``the least burdensome
requirements'' that protect ``adequately'' against unreasonable risk,
15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under
the CPSA must impose ``the least burdensome requirement which prevents
or adequately reduces the risk of injury for which the rule is being
promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at
variance with recent revisions to TSCA, affect the availability of
action CPSC may take under the Federal Hazardous Substances Act (FHSA)
relative to action EPA may take under TSCA. 15 U.S.C. 1262.
EPA therefore concludes that TSCA is the only regulatory authority
able to prevent or reduce unreasonable risk of PCE to a sufficient
extent across the range of conditions of use, exposures and populations
of concern. This unreasonable risk can be addressed in a more
coordinated, efficient and effective manner under TSCA than under
different laws implemented by different agencies. Moreover, the
timeframe and any exposure reduction as a result of updating OSHA or
CPSC regulations cannot be estimated, while TSCA requires a much more
accelerated 2-year statutory timeframe for proposing and finalizing
regulatory requirements to address unreasonable risk. Further, there
are key differences between the finding requirements of TSCA and those
of the OSH Act, CPSA, and FHSA. For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk from PCE may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. However, EPA is requesting public comment
on this issue (i.e., the sufficiency of an action taken under a Federal
law not administered by EPA).
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk unless
the Administrator determines in the Administrator's discretion that it
is in the public interest to protect against such risk under TSCA. In
making such a public interest finding, TSCA section 9(b)(2) states:
``the Administrator shall consider, based on information reasonably
available to the Administrator, all relevant aspects of the risk . . .
and a comparison of the estimated costs and efficiencies of the action
to be taken under this title and an action to be taken under such other
law to protect against such risk.''
Although several EPA statutes have been used to limit PCE exposure
(Ref. 6), regulations under those EPA statutes have limitations because
they largely regulate releases to the environment, rather than
occupational or consumer exposures. While these limits on releases to
the environment are protective in the context of their respective
statutory authorities, regulation under TSCA is also appropriate for
occupational and consumer exposures and in some cases can provide
upstream protections that would prevent the need for release
restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)).
The primary exposures and unreasonable risk to consumers,
bystanders, workers, and ONUs would be addressed by EPA's proposed
prohibitions and restrictions under TSCA section 6(a). In contrast, the
timeframe and any exposure reduction as a result of updating
regulations for PCE under the CAA, CWA, or RCRA cannot be estimated,
nor would they address the direct human exposure to consumers,
bystanders, workers, and ONUs from the conditions of use evaluated in
the 2020 Risk Evaluation for PCE. More specifically, none of EPA's
other statutes (e.g., RCRA, CAA, CWA) can address exposures to workers
and ONUs related to the specific activities that result in occupational
exposures, for example those associated with RCRA covered disposal
requirements. EPA therefore concludes that TSCA is the most appropriate
regulatory authority able to prevent or reduce risks of PCE to a
sufficient extent across the range of conditions of use, exposures, and
populations of concern.
For these reasons, the Administrator does not determine that
unreasonable risk from PCE under the conditions of use evaluated in the
2020 TSCA Risk Evaluation for PCE could be eliminated or reduced to a
sufficient extent by actions taken under other Federal laws
administered in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI that may occur
if this rule is finalized as proposed. Under TSCA section 14(b)(4), if
EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a
ban or phase-out of a chemical substance, the protection from
disclosure of any CBI regarding that chemical substance and submitted
pursuant to TSCA will be ``presumed to no longer apply,'' subject to
the limitations identified in TSCA section 14(b)(4)(B)(i) through
(iii). If this rule is finalized as proposed, then pursuant to TSCA
section 14(b)(4)(B)(iii), the presumption against protection from
disclosure would apply only to information about the specific
conditions of use that this rulemaking would prohibit or phase out.
Manufacturers or processors seeking to protect such information would
be able to submit a request for nondisclosure as provided by TSCA
sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure
would need to be submitted within 30 days after receipt of notice from
EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such
notice via the Central Data Exchange or CDX.
D. TSCA Section 26 Considerations
In accordance with TSCA section 26(h), EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science.
As in the case of the unreasonable risk determination, risk management
decisions for this proposed rule, as discussed in Unit III.B.3. and
Unit V., were based on a risk evaluation that was subject to public
comment and independent, expert peer review, and was developed in a
manner consistent with the best available science and based on the
weight of the scientific evidence as required by TSCA sections 26(h)
and (i) and 40 CFR 702.43 and 702.45.
In particular, the ECEL value incorporated into the WCPP and de
[[Page 39706]]
minimis concentration limit are derived from the analysis in the 2020
Risk Evaluation for PCE; they likewise represent decisions based on the
best available science and the weight of the scientific evidence (Refs.
10, 45, 53). The ECEL value of 0.14 ppm as an 8-hour TWA is based on
the chronic non-cancer HEC for neurotoxicity identified in the 2020
Risk Evaluation for PCE, which is the concentration at which an adult
human would be unlikely to suffer adverse effects if exposed for a
working lifetime, including susceptible subpopulations. As discussed in
Unit V.A.1., EPA used models from the 2020 Risk Evaluation for PCE to
derive the proposed de minimis concentration limit, which represents a
level below which EPA would not expect product use to drive
unreasonable risk.
The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decisions have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rulemaking. Additional information on the peer review and
public comment process, such as the peer review plan, the peer review
report, and the Agency's response to comments, can be found in EPA's
risk evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0732).
VIII. Requests for Comment
EPA is requesting public comment on all aspects of this proposal,
including the proposed and alternative regulatory actions and all
individual elements of these, and all supporting analysis.
Additionally, within this proposal, the Agency is soliciting feedback
from the public on specific issues throughout this proposed rule. For
ease of review, this section summarizes those specific requests for
comment.
1. EPA is requesting public comment on all elements of the proposed
regulatory action and the alternative regulatory actions.
2. EPA is requesting public comment regarding the need for
exemptions from the rule (and under what specific circumstances),
including exemptions from the proposed regulatory action (e.g., a WCPP)
and the primary and second alternative regulatory actions, pursuant to
the provisions of TSCA section 6(g).
3. 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.
4. EPA requests comment on whether EPA should promulgate
definitions for the conditions of use covered by 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.
5. 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.''
6. EPA requests comment regarding the number of businesses or other
entities that could potentially close as well as associated costs with
a prohibition of PCE for certain industrial and commercial conditions
of use identified in this unit.
7. EPA requests comment on the proposed compliance dates for
prohibitions of PCE manufacturing, processing, distribution in
commerce, and use and whether additional time is needed, for example,
for products to clear the channels of trade, or for implementing the
use of substitutes; comments should include documentation such as the
specific use of the chemical throughout the supply chain; concrete
steps taken to identify, test, and qualify substitutes for those uses
(including details on the substitutes tested and the specific
certifications that would require updating); and estimates of the time
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply.
8. 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.
9. EPA requests comment on allowing a de minimis level of PCE in
products (i.e., concentrations less than 0.1% by weight) to account for
impurities.
10. 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.
11. EPA is requesting comment on issues around the viability of
current analytical methods and detection limits for occupational
perchloroethylene sampling and/or monitoring methods.
12. 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. EPA is also
soliciting comments regarding use of area sampling instead of personal
breathing zone as a representative sample of exposures.
13. EPA requests comment on the timeframes for periodic monitoring
outlined in Table 1 of this unit.
14. 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.
15. 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.
16. EPA is requesting comment on whether there should be a
requirement to replace cartridges or canisters after a certain number
of hours, such as the requirements found in OSHA's General Industry
Standard for 1,3-Butadiene, or a requirement for a minimum service life
of non-powered air-purifying respirators such as the requirements found
in OSHA's General Industry Standard for Benzene.
17. 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.
18. EPA is requesting comment on how owners and operators can
engage with potentially exposed persons on the development and
implementation of an exposure control plan and PPE program.
[[Page 39707]]
19. EPA requests comment relative to the ability of owners or
operators to conduct initial monitoring within 6 months after date of
publication of the final rule in the Federal Register, and anticipated
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit, including establishment of a
respiratory protection program and development of an exposure control
plan. EPA also requests comment relative to the ability of owners or
operators to implement processes for occupational conditions of use
which are subject to DDCC requirements within 12 months of publication
of the final rule in the Federal Register, and anticipated timelines
for any procedural adjustments needed to comply with the requirements
outlined in this unit.
20. EPA requests comment on whether it should incorporate in the
rule best practices to ensure proper and adequate performance of
laboratory fume hoods, such as those identified in OSHA's 29 CFR
1910.1450, Appendix A National Research Council Recommendations
Concerning Chemical Hygiene in Laboratory. Additionally, EPA requests
comment relative to the ability of owners or operators to implement
laboratory chemical fume hood and dermal PPE related requirements
within 12 months of publication of the final rule, and anticipated
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit.
21. EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
22. EPA requests comment on the primary alternative regulatory
action (a combination of prohibitions, requirements for a WCPP, and
prescriptive controls) and whether any elements of this primary
alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. In particular,
EPA is requesting comment on the likelihood of successful compliance
with a PCE WCPP, as described in Unit IV.A., for the conditions of use
listed for the primary alternative regulatory action of PCE WCPP in
Unit IV.B. Further, EPA is soliciting comment on prescribing specific
engineering or administrative controls that would reduce inhalation and
dermal exposures enough to address the unreasonable risk across all
workplaces engaged in a condition of use. EPA also requests comment on
any advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
23. EPA requests comment on the ways in which PCE may be used in
the conditions of use for which the primary alternative regulatory
action would require a WCPP, including whether activities may take
place in a closed system and the degree to which users of PCE in these
sectors could successfully implement an ECEL, DDCC, and ancillary
requirements described in Unit IV.A. For the industrial and commercial
use in laboratory chemicals, EPA is soliciting comment on non-
prescriptive requirements of an ECEL and DDCC as compared to the
prescriptive workplace controls of fume hood and dermal PPE EPA is
proposing in Unit IV.A.3.
24. Regulated entities would be required to implement an exposure
control plan within 18 months after date of publication of the final
rule in the Federal Register. EPA requests comment on any advantages or
drawbacks for the timelines outlined in this unit compared to the
timelines identified for the proposed regulatory action in Unit IV.A.
25. EPA is soliciting comment on prescribing specific dermal PPE,
such as gloves, for each condition of use that should be considered as
EPA develops the final regulatory action. Additionally, EPA is
soliciting comment on prescribing specific respirators or APFs for
respirators for each condition of use that should be considered as EPA
develops the final regulatory action.
26. EPA is requesting comment on specific controls that mitigate
the unreasonable risk from PCE and that could be included as part of a
prescriptive workplace controls requirement, which could be considered
as EPA develops the final regulatory action. Specifically, EPA is
soliciting comment on combinations of specific engineering controls,
administrative controls, and PPE that would reduce inhalation exposures
to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct
dermal contact with PCE for all workplaces where such controls would be
required. EPA also is soliciting comment on the extent to which such
requirements could reduce inhalation exposures to at or below the ECEL
of 0.014 ppm as an 8-hour TWA. Additionally, EPA is requesting comment
on the compliance timeframe needed to implement engineering controls,
administrative controls, and PPE that reduce inhalation exposures to at
or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal
contact with PCE for all regulated entities.
27. EPA requests comment on a combination of the 1% concentration
limit for adhesives and sealants with specific engineering controls,
administrative controls, or respiratory protection that would reduce
inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-
hour TWA. Additionally, EPA is requesting comment on a combination of a
concentration limit with WCPP requirements. EPA also requests
monitoring data, formulations used, and detailed descriptions of PCE
involving activities for the industrial and commercial use in solvent-
based adhesives and sealants to determine whether a concentration limit
would reduce inhalation exposures such that risks are no longer
unreasonable.
28. EPA requests comment on the second alternative regulatory
action (a combination of prohibition and a WCPP) and whether any
elements of this second alternative regulatory action described in this
unit should be considered as EPA develops the final regulatory action.
EPA also requests comment on any advantages or drawbacks for the
timelines outlined in this unit compared to the timelines identified
for the proposed regulatory action in Unit IV.A.
29. EPA requests comments on all aspects of the section 6(g)
exemption from the prohibition on industrial and commercial use of PCE
in maskant for chemical milling as part of the second alternative
regulatory option, including information on the extent to which the
industry could meet the requirements of the proposed WCPP or
prescriptive controls and whether compliance with specific elements of
the proposed WCPP should also be required during the period of the
exemption.
30. EPA requests comments on all aspects of the exemption request
and proposed exemption from the prohibition on use of PCE in vapor
degreasing as part of the second alternative regulatory action,
including information on the extent to which this industry could meet
the requirements of the proposed WCPP or prescriptive controls and
whether compliance with specific elements of the proposed WCPP should
also be required during the period of the exemption.
31. EPA is requesting comment on whether to consider a regulatory
alternative that would subject more conditions of use to a WCPP,
instead of prohibition, than those currently contemplated in the
primary alternative regulatory action. EPA also requests monitoring
data and detailed descriptions of PCE involving activities for these
conditions of use to determine
[[Page 39708]]
whether these additional conditions of use could comply with the WCPP
such that risks are no longer unreasonable.
32. EPA is requesting comment on whether vapor degreasing of parts
and components for non-aerospace applications should also be exempt
from prohibition as part of the second alternative regulatory action
for the industrial and commercial use of PCE in vapor degreasing. To
facilitate EPA's consideration of exemptions for other sectors,
comments in support of additional exemptions should include detailed
explanations of why and how long exemptions would be needed.
33. EPA is soliciting comment on whether it should specify the type
of vapor degreasing operation, such as closed loop batch vapor
degreasing, that would be exempt from prohibition as part of the second
alternative regulatory action for the industrial and commercial use of
PCE in vapor degreasing for aerospace parts and whether it should
consider different exemption timeframes for different types of vapor
degreasing operations.
34. Each owner or operator would be required to provide respiratory
protection to all potentially exposed persons in the regulated area
within 3 months after receipt of the results of any exposure monitoring
or within 6 months after date of publication of the final rule in the
Federal Register. Regulated entities would be required to implement an
exposure control plan within 9 months after date of publication of the
final rule in the Federal Register. EPA requests comment on any
advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
35. EPA is requesting comment on the de minimis concentration limit
of PCE in products or formulations.
36. EPA is requesting comment on the extent to which facilities
engaged in the industrial and commercial use of PCE as a processing aid
in catalyst regeneration in petrochemical manufacturing may already
meet the requirements in the proposed and alternative regulatory
actions described in Unit IV. to address the unreasonable risk and is
soliciting comment on the impact of such requirements on petroleum
refining, with special attention to the price of gasoline.
37. EPA is requesting comment on whether preventing dermal contact
with PCE through dermal PPE and training would adequately address the
unreasonable risk from dermal exposures for the industrial and
commercial use in laboratory chemicals.
38. EPA is requesting comment on whether to include a self-
certification requirement for purchasing PCE or PCE-containing
products.
39. As part of the primary alternative regulatory action, EPA is
soliciting comment on prescribing specific engineering or
administrative controls that would reduce inhalation and dermal
exposures enough to address the unreasonable risk across all workplaces
engaged in a condition of use.
40. EPA is soliciting comments on whether, for those product types
relevant to industrial, commercial, and consumer conditions of use
proposed to be prohibited or significantly restricted where EPA was
unable to identify products currently available for sale that contain
PCE, there are products in use or available for sale relevant to these
conditions of use that contain PCE at this time, so that EPA can
ascertain whether there are alternatives that benefit human health or
the environment as compared to such use of PCE.
41. EPA is requesting comment on the Alternatives Assessment as a
whole.
42. EPA requests comment on whether owners and operators should be
required to attest to whether and why the exposure controls they have
selected would not result in increased air releases of PCE from the
workplace, and keep records of that statement as part of the WCPP
exposure control plan.
43. EPA is requesting comment on the estimated economic impacts to
the dry cleanining industry, including regarding expected closures.
44. EPA is requesting public comment on an issue raised in its TSCA
section 9(a) Analysis (i.e., the sufficiency of an action taken under a
Federal law not administered by EPA).
45. EPA requests comments on whether it should incorporate in the
rule voluntary consensus standards that meet specified performance
criteria for environmental monitoring or measurement and seeks
information in support of such comments regarding the availability and
applicability of voluntary consensus standards that may achieve the
sampling and analytical requirements of the rule in lieu of the
proposed approach.
46. Following Panel report recommendations (Ref. 33) and in
response to input provided by SERs, EPA is requesting comment on the
following topics as outlined in the SBAR Panel Report:
EPA requests public comment on the extent to which a
regulation under TSCA section 6(a) could minimize requirements, such as
testing and monitoring protocols, recordkeeping, and reporting
requirements, which may exceed those already required under OSHA's
regulations for PCE.
EPA requests comment on the methodology and inputs for the
ECEL value that are directly derived from the peer reviewed analysis in
the December 2020 Risk Evaluation.
EPA requests comment on reasonable compliance timeframes
for small businesses.
EPA requests comment on differing compliance or reporting
requirements or timetables that account for the resources available to
small entities.
EPA requests public comment on specific compliance
timeframes for the laundry industry.
EPA requests comment on any additional appropriate factors
for identifying reasonable compliance timeframes and how to weigh the
factors for dry cleaning and other industries.
EPA requests public comment about the feasibility of
entities complying with and monitoring for a potential ECEL of 0.14
ppm. Specifically, EPA aims to obtain more information on potential
costs that could be incurred using strategies to meet the requirements
of such a standard, such as engineering, administrative, or
prescriptive controls and how feasible it would be for entities to
implement these strategies in their operations.
EPA requests public comment about the feasibility of the
use of alternatives to PCE and their availability for conditions of use
that drive the unreasonable risk.
EPA requests public comment on the consideration for a
TSCA section 6(g) exemption and alternative compliance timeframes for
dry cleaning, including information on whether the specific use may be
critical or essential, why alternatives may not be feasible for this
condition of use, and the ideal time limit for an exemption.
IX. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation for Perchloroethylene. EPA Document #740-R1-
8011. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0058.
[[Page 39709]]
2. EPA. Final Revised Unreasonable Risk Determination for
Perchloroethylene, Section 5. December 2022.
3. EPA. Economic Analysis of the Proposed Regulation of
Perchloroethylene. RIN 2070-AK84. June 2023.
4. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last
Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
5. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16,
2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
6. EPA. Regulatory Actions Pertaining to Perchloroethylene. 2022.
7. OSHA. Standard Interpretations: 8-hr total weight average (TWA)
permissible exposure limit (PEL). Accessed January 13, 2023. https://www.osha.gov/laws-regs/standardinterpretations/1995-10-06-3.
8. NIOSH. Hierarchy of Controls. Page last reviewed: August 11,
2022. https://www.cdc.gov/niosh/topics/hierarchy/.
9. EPA. Perchloroethylene (PCE); Revision to Toxic Substances
Control Act (TSCA) Risk Determination; Notice of Availability.
Federal Register (87 FR 76481, December 14, 2022).
10. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Perchloroethylene. April 15, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0023.
11. Cavalleri et al. Perchloroethylene exposure can induce colour
vision loss. Neuroscience Letters 179: 162-166. August 10, 1994.
12. Echeverria et al. A Behavioral Evaluation of PCE Exposure in
Patients and Dry Cleaners: A Possible Relationship Between Clinical
and Preclinical Effects. JOEM Vol. 37, Number 6, 667-680. June 1995.
13. AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992).
14. ACGIH. Supplement: Perchloroethylene. CAS: 127-18-4. Copyright
1996.
15. EPA. A Review of the Reference Dose and Reference Concentration
Processes. December 2002. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/88824.
16. Cal/OSHA. Hazard Risk Assessment Project for California:
Identification of Chemicals of Concern, Possible Risk Assessment
Methods, and Examples of Health Protective Occupational Air
Concentrations. December 2007. https://www.cdph.ca.gov/Programs/CCDP,HP/DEODC/OHB/HESIS/CDPH%20Document%20Library/riskreport.pdf.
17. NIOSH. Criteria for a Recommended Standard: Occupational
Exposure to Tetrachloroethylene (Perchloroethylene). Page last
reviewed: June 6, 2014. https://www.cdc.gov/niosh/docs/76-185/default.html.
18. NIOSH. NIOSH Pocket Guide to Chemical Hazards:
Tetrachloroethylene. Page last reviewed: October 30, 2019. https://www.cdc.gov/niosh/npg/npgd0599.html.
19. NIOSH. Appendix A--NIOSH Potential Occupational Carcinogens.
https://www.cdc.gov/niosh/npg/nengapdxa.html.
20. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
21. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 20, 2021).
22. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
23. EPA. EPA Announces Path Forward for TSCA Chemical Risk
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
24. SACC. Science Advisory Committee on Chemicals Meeting Minutes
and Final Report No. 2022-01. March 15-17, 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0415-0095.
25. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
Methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
26. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE).
June 15, 2021 and July 8, 2021.
27. Peter Sinsheimer; Green Analytics. Comments on Environmental
Justice Consultation for TSCA PCE Risk Management of Dry Cleaning.
August 20, 2021.
28. Hans Kim; AQUA Wet Clean. Letter re: Environmental Justice
Consultation USEPA TSCA PCE Risk Management. August 20, 2021.
29. W. Heiger-Bernays and G. Nielsen. Comments on Environmental
Justice Consultation #2 for TCE and PCE. July 5, 2021.
30. Martin Arg[uuml]ello; Physicians for Social Responsibility.
USEPA EJ Consultation Meeting Comments on PCE and TCE TSCA
Regulations August 20, 2021.
31. Sa Liu; School of Health Sciences Purdue University. Letter re:
Environmental Justice Consultation on Forthcoming Proposed
Rulemakings under TSCA Section 6(a). August 20, 2021.
32. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and
Perchloroethylene (PCE). June 16 and July 6, 2021.
33. EPA. Final Report of the Small Business Advocacy Review Panel on
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA)
Section 6(a) Perchloroethylene. February 1, 2023.
34. EPA. Initial Regulatory Flexibility Analysis for
Perchloroethylene; Regulation of Perchloroethylene under TSCA Sec.
6(a) Proposed Rule; RIN 2070-AK84. June 2023.
35. EPA. Public Webinar on Perchloroethylene: Risk Evaluation and
Risk Management under TSCA Section 6. January 14, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0002.
36. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Perchloroethylene under TSCA Section 6(a).
37. EPA. 2021 Policy on Children's Health. October 5, 2021.
38. EPA. Problem Formulation of the Risk Evaluation for
Perchloroehtylene (Ethene, 1,1,2,2-Tetrachloro). EPA Document #EPA-
740-R1-7017. May 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0732-0080.
39. EPA. Final Risk Evaluation for Perchloroethylene: Supplemental
File: Releases and Occupational Exposure Assessment. December 2020.
https://www.regulations.gov/document/EPA-HQ-OAR-2005-0155-0565.
40. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane.
EPA Document #EPA-740-R-20-005. August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0427-0048.
41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register (62 FR 1494, January 10, 1997).
43. Tetrachloroethylene Vapor Monitor (OV-80). https://acsbadge.com/product/tetrachloroethylene-vapor-monitor-ov-80/.
44. OSHA. Recommended Practices for Safety and Health Programs.
October 2016. https://www.osha.gov/safety-management.
45. EPA. Perchloroethylene (PCE): Risk Management Support Documents.
November 18, 2022.
46. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
47. National Research Council. Prudent Practices in the Laboratory:
Handling and Management of Chemical Hazards, Updated Version. 2011.
https://www.nationalacademies.org/our-work/prudent-practices-in-the-laboratory-an-update.
48. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016.
49. EPA. Meeting with The Chemours Company on Risk Management under
TSCA Section 6 and Perchloroethylene. February 23, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0008.
50. EPA. Meeting with Honeywell on Risk Management under TSCA
Section 6 and Perchloroethylene (PCE). March 25, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0018.
51. EPA. Perchloroethylene (PCE): Risk Management Support--PCE
Adhesive Use. May 24, 2023.
52. EPA. Risk Management for Perchloroethylene Supplemental File:
Occupational Risk Calculator. CASRN: 127-18-4. December 2021.
[[Page 39710]]
53. EPA. Risk Management for Perchloroethylene Supplemental File:
Consumer Risk Calculator. CASRN: 127-18-4. March 2021.
54. EPA. Meeting with Spirit AeroSystems on Risk Management under
TSCA Section 6 and Perchloroethylene (PCE). March 11, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0013.
55. IAMAW. Letter to EPA from International Association of
Machinists and Aerospace Workers. August 18, 2021.
56. EPA. An Alternatives Assessment for Use of Perchloroethylene RIN
2070-AK84. November 2022.
57. The Boeing Company. Comments Supporting Request for Additional
Information on Perchloroethylene (PCE); Rulemaking Under TSCA
Section 6(a) May 6, 2022.
58. The Boeing Company. Comments Supporting Request for Additional
Information on Perchloroethylene (PCE); Rulemaking Under TSCA
Section 6(a). September 23, 2022.
59. NASA. Known Uses of Perchloroethylene. Updated December 14,
2022.
60. Steve Shestag; The Boeing Company. Information on FAA
Certification. December 9, 2022.
61. EPA. Meeting with State and Local TSCA Coordination Group on
Risk Management under TSCA Section 6 for Perchloroethylene. July 11,
2022.
62. EPA. Meeting with state and local government representatives on
Risk Management under TSCA Section 6 for Perchloroethylene. June 17,
2021.
63. EPA. Meeting with Honeywell UOP on Risk Management under TSCA
Section 6 for Perchloroethylene (PCE) in Petrochemical
Manufacturing. June 9, 2021.
64. AFPM and API. Comment of the American Fuels & Petrochemical
Manufacturers and the American Petroleum Institute on Draft Revision
to Toxic Substances Control Act (TSCA) Risk Determination
Perchloroethylene. August 1, 2022. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0122.
65. AFPM. AFPM Comments on the Notice--``Problem Formulations for
the Risk Evaluations To Be Conducted for the First Chemical
Substances Under the Toxic Substances Control Act, and Application
of Systematic Review in TSCA Risk Evaluations; Extension of Comment
Period; Tetrachloroethylene (also known as perchloroethylene)''.
August 16, 2018. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0108.
66. EPA. Meeting with the American Fuel and Petrochemical
Manufacturers on Risk Management under TSCA Section 6 for
Perchloroethylene. July 29, 2021.
67. NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH)
Publication No. 2005-149. September 2007. https://www.cdc.gov/niosh/npg/default.html.
68. HSIA. Comment letter from the Halogenated Solvents Industry
Alliance, Inc. on the draft perchloroethylene TSCA risk evaluation.
July 6, 2020. https://www.regulations.gov/comment/EPA-HQ-OPPT-2019-0502-0053.
69. EPA. Risk Evaluation for Perchloroethylene (Ethylene, 1,1,2,2-
Tetrachloro) Systematic Review Supplemental File: Data Quality
Evaluation of Environmental Releases and Occupational Exposure.
CASRN: 127-18-4. April 2020.
70. EPA. Meeting with National Cleaners Association on Risk
Management under TSCA Section 6 and Perchloroethylene (PCE). January
28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0006.
71. EPA. Meeting with New York State Department of Environmental
Conservation on Risk Management under TSCA Section 6 for
Perchloroethylene. June 10, 2021.
72. EPA. Perchloroethylene: Fenceline Technical Support--Water
Pathway. October 6, 2022.
73. EPA. Perchloroethylene: Fenceline Technical Support--Air
Pathway. December 8, 2022.
74. OEJECR. EPA Complaint Nos. 01R-22-R6-, 02R-22-R6, and 04R-22-R6.
October 12, 2022.
75. EPA. Exposure and Fate Assessment Screening Tool Version 2014
(E-FAST 2014). Washington, DC: Office of Pollution Prevention and
Toxics. Last updated: February 17, 2022. https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014.
76. National Water Quality Monitoring Council (NWQMC): Water Quality
Portal. 2017. https://www.waterqualitydata.us/.
77. William P.L. Carter. Development of the SAPRC-07 Chemical
Mechanism and Updated Ozone Reactivity Scales. Center for
Environmental Research and Technology, College of Engineering,
University of California. Revised January 27, 2010.
78. World Meteorological Organization. Scientific Assessment of
Ozone Depletion: 2018. Global Ozone Research and Monitoring
Project--Report No. 58. https://ozone.unep.org/sites/default/files/2019-05/SAP-2018-Assessment-report.pdf.
79. ATSDR. Toxicological Profile for Tetrachloroethylene. June 2019.
https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=265&tid=48.
80. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of
Perchloroethylene under TSCA Section 6(a). June 2023.
81. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical
Methods With Related International Voluntary Consensus Standards. J
Occup Environ Hyg. 12(7): D107-15. June 11, 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589148/.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'', as defined
under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4,
1993), as amended by Executive Order 14094 (88 FR 21879, April 11,
2023). Accordingly, EPA submitted this action to OMB for Executive
Order 12866 review. Documentation of any changes made in response to
the Executive Order 12866 review is available in the docket. EPA
prepared an economic analysis (Ref. 3) of the potential costs and
benefits associated with this action, which is also available in the
docket and summarized in Unit VI.D.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted to OMB for review and comment under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 2740.01 (Ref. 80). You can find
a copy of the ICR in the docket for this proposed rule, and it is
briefly summarized here.
There are two primary provisions of the proposed rule that may
increase burden under the PRA. The first is downstream notification,
which would be carried out by updates to the relevant SDS and which
would be required for manufacturers, processors, and distributors in
commerce of PCE, who would provide notice to companies downstream upon
shipment of PCE about the prohibitions. The information submitted to
downstream companies through the SDS would provide knowledge and
awareness of the restrictions to these companies. The second primary
provision of the proposed rule that may increase burden under the PRA
is WCPP-related information generation, recordkeeping, and notification
requirements (including development of exposure control plans; exposure
level monitoring and related recordkeeping; development of
documentation for a PPE program and related recordkeeping; development
of documentation for a respiratory protection program and related
recordkeeping; development and notification to potentially exposed
persons (employees and others in the workplace) about how they can
access the exposure control plans, exposure monitoring records, PPE
program
[[Page 39711]]
implementation documentation, and respirator program documentation; and
development of documentation demonstrating eligibility for an exemption
from the proposed prohibitions, and related recordkeeping).
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce, or dispose of PCE or products containing
PCE. See also Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
Estimated number of respondents: 12,091.
Frequency of response: On occasion.
Total estimated burden: 64,622 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $7,625,325 (per year), includes $2,753,517
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. After display in the Federal
Register when approved, the OMB control numbers for certain EPA
regulations in title 40 of the CFR are listed in 40 CFR part 9 and
displayed on the form and instructions or collection portal, as
applicable.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this proposed rule. You may also send your ICR-
related comments to OMB's Office of Information and Regulatory Affairs
using the interface at https://www.reginfo.gov/public/do/PRAMain. Find
this particular ICR by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. OMB must receive
comments no later than August 15, 2023. EPA will respond to ICR-related
comments in the final rule.
C. Regulatory Flexibility Act (RFA)
As required by section 609(b) of the RFA, EPA convened a SBAR Panel
to obtain advice and recommendations from SERs that potentially would
be subject to the rule's requirements. The SBAR Panel evaluated the
assembled materials and small-entity comments on issues related to
elements of an initial regulatory flexibility analysis (IRFA). A copy
of the full SBAR Panel Report (Ref. 33) is available in the rulemaking
docket.
Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an IRFA (Ref. 34) that examines the impact of the proposed
rule on small entities along with regulatory alternatives that could
minimize that impact. The complete IRFA is available for review in the
docket and is summarized here.
1. Need for the Rule
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other nonrisk factors, including an
unreasonable risk to a PESS identified as relevant to the risk
evaluation, under the conditions of use, EPA must by rule apply one or
more requirements listed in TSCA section 6(a) to the extent necessary
so that the chemical substance or mixture no longer presents such risk.
PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A)
that was issued in December 2020. In addition, in December 2022, EPA
issued a revised unreasonable risk determination 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.
2. Objectives and Legal Basis
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in section 6(a)
to the extent necessary so that the chemical substance or mixture no
longer presents such risk. EPA has determined through a TSCA section
6(b) risk evaluation that PCE presents an unreasonable risk under the
conditions of use.
3. Description and Number of Small Entities to Which the Rule Will
Apply
The proposed rule potentially affects small manufacturers
(including importers), processors, distributors, retailers, users of
PCE or of products containing PCE, and entities engaging in disposal.
EPA estimates that the proposal would affect approximately 12,202 small
entities. Almost half (5,949) of these entities are commercial users of
PCE in dry cleaning applications. Users of products containing PCE,
including adhesives and sealants, aerosol cleaners/degreasers, liquid
cleaners/degreasers, mold cleaners, and other products also account for
about half of the affected small entities. EPA also estimates that 69
small entities use PCE in chemical milling, 88 use PCE in recycling and
disposal, and 30 incorporate PCE into other formulations, mixtures, and
reaction products.
4. Projected Compliance Requirements
To address the unreasonable risk EPA has identified, EPA is
proposing to: prohibit most industrial and commercial uses and the
manufacture (including import), processing and distribution in
commerce, of PCE for those uses; prohibit the manufacture (including
import), processing, and distribution in commerce of PCE for all
consumer use; prohibit the manufacture (including import), processing,
distribution in commerce, and use of PCE in dry cleaning and related
spot cleaning through a 10-year phaseout; require a PCE WCPP, which
would include requirements to meet an inhalation exposure concentration
limit and prevent direct dermal contact, for certain conditions of use
not prohibited; require prescriptive workplace controls for laboratory
use; and establish recordkeeping and downstream notification
requirements. There are an estimated 12,189 small entities affected by
the proposed option with a per firm cost of $715 with a total estimated
cost impact of $8.7 million. This includes $6.7 million for WCPP uses,
$1.9 million for uses that are prohibited, and $0.1 million for lab
uses.
EPA is proposing to prohibit most conditions of use. For most other
conditions of use that drive the unreasonable risk determination for
PCE, EPA proposes to address the unreasonable risk with a PCE WCPP,
which would include a combination of requirements to address
unreasonable risk driven by inhalation and dermal exposures in the
workplace. A PCE WCPP would encompass restrictions on certain
occupational conditions of use and could include provisions for an
ECEL, DDCC, and ancillary requirements to support implementation of
these restrictions. Due to the low exposure level and stringent
requirements in the PCE WCPP that would be necessary to address the
unreasonable risk from PCE, EPA identified only a relatively small
number of conditions of use where the Agency expected a PCE WCPP could
be successfully implemented.
As described in Unit IV.A., the PCE WCPP would be non-prescriptive,
in the sense that regulated entities would not be required to use
specific controls prescribed by EPA to achieve the
[[Page 39712]]
exposure concentration limit. Rather, it would be a performance-based
exposure limit that would enable owners or operators to determine how
to most effectively meet the exposure limit based on conditions at
their workplace.
A central component of the PCE WCPP is the exposure limit.
Exposures remaining at or below the ECEL would address any unreasonable
risk of injury to health driven by inhalation exposures for
occupational conditions of use. EPA's proposed requirements include the
specific exposure limits that would be required to meet the TSCA
section 6(a) standard to apply one or more requirements to the
substance so that it no longer presents unreasonable risk, and also
include ancillary requirements necessary for the ECEL's successful
implementation as part of a WCPP.
EPA is not proposing reporting requirements beyond downstream
notification (third-party notifications). Regarding recordkeeping
requirements, three primary provisions of the proposed rule relate to
recordkeeping. The first is recordkeeping of general records: all
persons who manufacture, process, distribute in commerce, or engage in
industrial or commercial use of PCE or PCE-containing products must
maintain ordinary business records, such as invoices and bills-of-
lading related to compliance with the prohibitions, restrictions, and
other provisions of the regulation.
The second is recordkeeping related to WCPP compliance: under the
proposed regulatory action, facilities complying with the rule through
WCPP would be required to develop and maintain records associated with
ECEL exposure monitoring (including measurements, compliance with Good
Laboratory Practice Standards, and information regarding monitoring
equipment); ECEL compliance (including the exposure control plan, PPE
program implementation, and workplace information and training); DDCC
compliance (including the exposure control plan, PPE program
implementation, basis for specific PPE selection, occurrence and
duration of direct dermal contact with PCE, and workplace information
and training); and workplace participation. To support and demonstrate
compliance, EPA is proposing that each owner or operator of a workplace
subject to the WCPP retain compliance records for five years.
EPA is also proposing to require specific prescriptive controls for
the industrial and commercial use of PCE in laboratory chemicals. To
reduce exposures in the workplace and address the unreasonable risk of
injury to health resulting from dermal exposures to PCE identified for
the industrial and commercial use as a laboratory chemical, EPA is
proposing to require dermal PPE in combination with comprehensive
training for tasks particularly related to the use of PCE in a
laboratory setting for each potentially exposed person to direct dermal
contact with PCE. Additionally, EPA is proposing to require the use of
fume hoods in workplaces engaged in the laboratory chemical condition
of use. To support and demonstrate compliance, EPA is proposing that
each owner or operator of a laboratory workplace subject to the
workplace controls for laboratory use requirements retain compliance
records for five years.
a. Classes of Small Entities Subject to the Compliance Requirements
The small entities that would be potentially directly regulated by
this rulemaking are small entities that manufacture (including import),
process, distribute in commerce, use, or dispose of PCE, including
retailers of PCE for end-consumer uses.
b. Professional Skills Needed To Comply
Entities that would be subject to this proposal that manufacture
(including import), process, or distribute PCE in commerce for consumer
use would be required to cease under the proposed rule. The entity
would be required to modify their SDS or develop another way to inform
their customers of the prohibition on manufacture, processing, and
distribution of PCE for consumer use. They would also be required to
maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate compliance with the prohibitions,
restrictions, and other provisions of this proposed regulation. These
are all routine business tasks that do not require specialized skills
or training.
Entities that use PCE in any industrial and commercial capacity
that is prohibited would be required to cease under the proposed rule.
Restriction or prohibition of these uses will likely require the
implementation of an alternative chemical or the cessation of use of
PCE in a process or equipment that may require persons with specialized
skills, such as engineers or other technical experts. Instead of
developing an alternative method themselves, commercial users of PCE
may choose to contract with another entity to do so.
Entities that would be permitted to continue to manufacture,
process, distribute, use (with the exception for use as a laboratory
chemical), or dispose of PCE would be required to implement a WCPP and
would have to meet the provisions of the program for continued use of
PCE. Entities that would be permitted to continue use of PCE as a
laboratory chemical would be required to implement prescriptive
workplace controls for laboratory use and would have to meet the
provisions of the workplace restrictions for continued use of PCE. A
transition to a WCPP or prescriptive workplace controls for laboratory
use may require persons with specialized skills such as an engineer or
health and safety professional. Instead of implementing the WCPP or
workplace controls for laboratory use themselves, entities that use PCE
may choose to contract with another entity to do so. Records would have
to be maintained for compliance with a WCPP or workplace controls for
laboratory use, as applicable. While this recording activity itself may
not require a special skill, the information to be measured and
recorded may require persons with specialized skills such as an
industrial hygienist.
5. Relevant Federal Rules
Because of its health effects, PCE is subject to numerous state,
Federal, and international regulations restricting and regulating its
use. The following is a summary of the regulatory actions pertaining to
PCE; for a full description see appendix A of the 2020 Risk Evaluation
for PCE and the summary in the docket (Ref. 6).
EPA has issued numerous rules and notices pertaining to PCE under
its various authorities. PCE is a hazardous air pollutant under the CAA
(42 U.S.C. 7412(b)(1)). EPA promulgated NESHAP for a number of source-
specific categories that emit PCE, including dry cleaning (40 CFR part
63, subpart M) and halogenated solvent cleaning (40 CFR part 63,
subpart T).
With this proposed rule under TSCA section 6, certain uses and
emissions already regulated under these NESHAP would be prohibited
while other uses would be subject to a WCPP.
Programs within EPA implementing other environmental statutes,
including, but not limited to, the RCRA, the Comprehensive
Environmental Response, Compensation, and Liability Act, the Safe
Drinking Water Act, and the CWA, classify PCE as a characteristic and
listed hazardous waste (40 CFR 261.24, 40 CFR 261.31, 40 CFR 261.33), a
hazardous substance (40 CFR 302.4), a contaminant subject to National
Primary Drinking Water Regulations (40 CFR 141.61), and a toxic
pollutant (40 CFR 401.15, 40 CFR part 423, appendix A, 40 CFR 131.36)
or the
[[Page 39713]]
program requires reportable criteria of releases into the environment
involving PCE. While TSCA shares equity in the regulation of PCE, EPA
does not anticipate this rulemaking to duplicate nor conflict with the
aforementioned programs' classifications and associated rules.
In addition to EPA actions, PCE is also subject to other Federal
regulations. Under the OSH Act, OSHA established the PEL for PCE at 100
ppm as an 8-hour TWA with an acceptable ceiling concentration of 200
ppm and an acceptable maximum peak above the acceptable ceiling
concentration for an 8-hour shift of 300 ppm, maximum duration of 5
minutes in any 3 hours. However, EPA recognizes that the existing PEL
does not eliminate the unreasonable risk identified by EPA under TSCA,
and EPA is therefore proposing to apply new, lower exposure thresholds,
derived from the TSCA 2020 Risk Evaluation for PCE, while aligning with
existing OSHA requirements where possible. For PCE, this approach would
eliminate the unreasonable risk driven by certain conditions of use,
reduce burden for complying with the regulations, and provide the
familiarity of a pre-existing framework for the regulated community.
Under the FHSA, visual novelty devices containing PCE are regulated
by the CPSC (16 CFR 1500.83(a)(31)). Under the FFDCA, the Food and Drug
Administration regulates PCE in bottled water and set the maximum
permissible level of PCE in bottled water to 0.005 mg/L (21 CFR
165.110). Under the Atomic Energy Act, the Department of Energy Worker
Safety and Health Program requires its contractor employees to use the
2005 ACGIH TLV for PCE, which is 25 ppm (8-hour TWA) and 100 ppm Short
Term Exposure Limit. Under the Federal Hazardous Material
Transportation Act, the Department of Transportation has designated PCE
as a hazardous material, and there are special requirements for
marking, labeling, and transporting it (49 CFR part 171, 49 CFR part
172, 40 CFR 173.202, and 40 CFR 173.242).
6. Significant Alternatives to the Proposed Rule
EPA analyzed alternative regulatory approaches to identify which
would be feasible, reduce burden to small businesses, and achieve the
objective of the statute (i.e., applying one or more requirements
listed in TSCA section 6(a) to the extent necessary so that the
chemical substance or mixture no longer presents an unreasonable risk).
As described in more detail in Unit V., EPA considered several factors,
in addition to identified unreasonable risk, when selecting among
possible TSCA section 6(a) requirements. To the extent practicable, EPA
factored into its decisions: the effects of PCE on health and the
environment, the magnitude of exposure to PCE of human beings and the
environment, the benefits of PCE for various uses, and the reasonably
ascertainable economic consequences of the proposed rule. EPA also
considered input provided by the SERs in selecting among possible TSCA
section 6(a) requirements as part of the proposed regulatory action and
alternative regulatory actions, particularly as it related to dry
cleaners' compliance timeframes. Overall, EPA expects few dry cleaning
facility closures because EPA estimates that only about 60 PCE machines
are expected to be in use at the end of the proposed phaseout period,
based on SER input and given the age of the machines and the declining
trend of use. Additionally, as s part of this analysis, EPA
considered--in addition to prohibition, WCPP, and prescriptive controls
described earlier--a wide variety of control measures to address the
unreasonable risk from PCE such as weight fractions and a point-of-sale
self-certification requirement. EPA's analysis of these risk management
approaches is detailed in Unit V.A.3. In general, EPA determined that
these approaches alone would either not be able to address the
unreasonable risk, or, in the case of a weight fraction limit, would
result in a product containing so little PCE that it would have the
effect of a prohibition.
Weight Fractions: As discussed in Unit V.A.3., EPA considered
limiting the weight fraction of PCE in industrial/commercial and
consumer products and conducted an analysis to estimate to what extent
this would reduce risks from conditions of use that drive the
unreasonable risk for PCE. EPA determined that the unreasonable risk
from PCE would not be driven by use of products containing PCE at less
than 0.1% by weight. Therefore, EPA is proposing a de minimis level for
products containing PCE at levels of less than 0.1% to account for
impurities that do not drive the unreasonable risk., as described in
Unit IV.A.1.d. For most industrial/commercial and consumer conditions
of use, the weight fraction or concentration identified through this
modeling that would address the unreasonable risk through inhalation or
dermal pathways was so low that it was highly unlikely that PCE would
still serve its functional purpose in the formulation. EPA thus
concluded that a weight fraction limit would essentially function as a
prohibition yet with a greater amount of uncertainty regarding
compliance and no increased benefit to users; it was therefore not a
preferred option. For the industrial and commercial use in solvent-
based adhesives and sealants, EPA identified several products available
on the market at concentrations of PCE between 0.1% and 1% by weight in
the 2020 Risk Evaluation for PCE. As part of the primary alternative
regulatory action, EPA would set a concentration limit of PCE in
adhesive and sealant products for industrial and commercial use to 1%,
as described in Unit IV.B.1.c.
Point-of-sale self-certification: As discussed in Unit V.A.3., EPA
also examined the extent to which a point-of-sale self-certification
requirement in order to purchase and subsequently use PCE would further
ensure that only facilities able to implement and comply with a WCPP or
prescriptive controls are able to purchase and use PCE, and self-
certify to that. Under a self-certification requirement, entities would
submit a self-certification to the distributor or retailer each time
PCE is purchased. The self-certification would consist of a statement
indicating that the facility is implementing a WCPP or required
prescriptive controls to control exposures to PCE; the self-
certification would be signed and presented by a person authorized to
do so by the facility owner or operator. Copies of the self-
certification would be maintained as records by both the owner or
operator and the distributor or retailer where PCE was purchased.
However, because of the number and types of entities where users can
obtain PCE or PCE-containing products, EPA does not believe the added
requirement and subsequent burden of a point-of-sale self-certification
requirement for the use of PCE would be an effective tool for
preventing facilities that may be unable to comply with the WCPP or
prescriptive controls of this proposed rulemaking from accessing PCE or
PCE-containing products. As such, EPA is not proposing a self-
certification requirement as an additional component of the
requirements for addressing the unreasonable risk of occupational
exposures to PCE.
Prescriptive controls: As discussed in Unit V.A.1., EPA considered
prescriptive controls (i.e., engineering or administrative controls, or
PPE) and has determined that prescriptive controls may not be able to
eliminate unreasonable risk for some conditions of use when used in
isolation. In the 2020 Risk Evaluation for PCE, analysis of
occupational exposure scenarios (OES) indicated that many conditions of
use
[[Page 39714]]
still posed risk concerns even with the application of respirators with
APF 25 or 50. Because of the uncertainty regarding the feasibility of
exposure reductions through engineering controls alone, EPA determined
that a PCE WCPP ECEL, which would be accompanied by monitoring
requirements in tandem with the implementation of engineering controls,
administrative controls, and/or PPE as elements of the program, as
appropriate, would more successfully reduce exposure so that the
unreasonable risk is addressed. Additionally, relying primarily on
respirators and gloves to reduce exposures does not consider other more
protective controls in the hierarchy, including elimination,
substitution, engineering controls, and administrative controls. For
occupational conditions of use where compliance with the PCE WCPP ECEL
and DDCC is unlikely to be successful, in most cases prohibitions
(rather than prescribed controls) would be more appropriate to ensure
that PCE does not present unreasonable risk under the conditions of
use. EPA is proposing prescriptive workplace controls for laboratory
use to codify assumptions made in the 2020 Risk Evaluation for PCE
regarding the use of fume hoods in laboratory settings and because EPA
has preliminarily determined that chemically resistant gloves in
combination with specific activity training for tasks where dermal
exposure can be expected to occur in laboratory settings would address
the unreasonable risk resulting from dermal exposures. Additionally, as
part of the primary alternative regulatory action, EPA includes certain
prescriptive controls (PPE in combination with monitoring, regulated
area, and training) for conditions of use for which EPA is proposing
WCPP as the regulatory action.
As indicated by this overview, and detailed in Unit V.A, in the
review of alternatives, EPA determined that some methods either did not
effectively eliminate the unreasonable risk presented by PCE or, for
many conditions of use, there was a high degree of uncertainty
regarding whether compliance with a comprehensive WCPP or prescriptive
controls would be possible to adequately protect potentially exposed
persons. The primary alternative regulatory action and second
regulatory action were considered and found to provide greater
uncertainty in addressing the unreasonable risk from PCE under the
conditions of use, resulting in EPA's proposed action. Information on
the costs and benefits of the proposed and alternative regulatory
actions is available in Chapters 7 and 8 of the Economic Analysis
Analysis and analysis on small entity impacts is in Chapter 10 of the
Economic Analysis.
EPA considered its authority under TSCA section 6(g) to grant a
time-limited exemption for conditions of use where compliance with a
requirement would significantly disrupt the national economy, national
security, or infrastructure. As described in Units IV.B.2.b. and
V.A.2., based on reasonably available information, EPA analyzed the
need for an exemption and has found that a TSCA section 6(g) exemption
may be warranted under the second alternative regulatory action for the
industrial and commercial use in maskant for chemical milling and for
the industrial and commercial use in vapor degreasing if the workplaces
engaged in those conditions of use cannot meet the requirements of the
proposed regulatory action (PCE WCPP) or primary alternative regulatory
action (prescriptive controls) such that those conditions of use would
no longer drive the unreasonable risk. A section 6(g) exemption may
mean that the unreasonable risk will not be fully addressed.
As required under TSCA section 6(c)(2)(C) and detailed in Unit
V.B., EPA also considered to the extent practicable whether technically
and economically feasible alternatives that benefit human health or the
environment, compared to the use so proposed to be prohibited or
restricted, will be reasonably available as a substitute when the
proposed prohibition or other restriction takes effect. To that end, in
addition to the Economic Analysis (Ref. 3), EPA conducted an
Alternatives Assessment, using reasonably available information (Ref.
56). For this assessment, EPA identified and analyzed alternatives to
PCE in products relevant to industrial, commercial, and consumer
conditions of use. Based on reasonably available information, including
information submitted by industry, EPA understands viable alternatives
to PCE may not be available for several conditions of use--for example,
the industrial and commercial use in vapor degreasing for certain
applications (Refs. 57, 58)--and considered that information to the
extent practicable in the development of the regulatory options.
Regarding timeframes for compliance, as described in Unit IV.A.1,
2, and 3, the proposed compliance dates incorporate EPA's consideration
of sustained awareness of risks resulting from PCE exposure as well as
precedent established by the OSHA standards (62 FR 1494, January 10,
1997). TSCA requires that EPA propose timeframes that are ``as soon as
practicable'' under TSCA section 6(d)(1)(B) and 6(d)(1)(D). TSCA
section 6(d)(1)(C) also requires that EPA specify mandatory compliance
dates for the start of ban or phase-out requirements ``as soon as
practicable'' but not later than five years after the promulgation date
of a rule. In developing the proposed compliance timeframes, including
for the prohibition and phaseout of PCE in dry cleaning as outlined in
Unit IV.A.1.c., EPA considered reasonably available information. EPA
has no information indicating that the proposed compliance dates are
not practicable for the activities that would be prohibited, or that
additional time is needed for products affected by the proposed
restrictions to clear the channels of trade. As noted earlier, EPA is
seeking public comment on whether additional time is needed for
compliance with prohibitions, for products to clear the channels of
trade, or for implementing a WCPP or prescriptive controls. EPA may
finalize shorter or longer compliance timeframes based on public
comment. Regarding potential regulatory flexibilities for compliance
dates and timeframes, EPA notes that the primary alternative regulatory
action would include longer compliance timeframes for prohibitions.
Given the potential severity of impacts from exposure to PCE, EPA's
proposed regulatory action and second alternative regulatory action
would include relatively rapid compliance timeframes. However, it is
possible that longer timeframes would be needed for entities to come
into compliance; therefore, the primary alternative regulatory action
described in the proposed rule would include longer timeframes for
implementation than the proposed regulatory action. These timeframes
are detailed in Unit IV. Information on the estimated costs of the
shorter and longer timeframes for the dry cleaning phaseout are in
Chapter 7.7.3 of the Economic Analysis.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action would
affect entities that use PCE. It is not expected to affect State,
local, or Tribal governments because the use of PCE by government
entities is minimal. This action is not expected to result in
expenditures by State, local, and Tribal governments, in the
[[Page 39715]]
aggregate, or by the private sector, of $100 million or more (when
adjusted annually for inflation) in any 1 year. Accordingly, this
action is not subject to the requirements of sections 202, 203, or 205
of UMRA.
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulations under TSCA section 6(a) may preempt State law. As
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA
section 6(a) to address the unreasonable risk presented by a chemical
substance has the potential to trigger preemption of laws, criminal
penalties, or administrative actions by a State or political
subdivision of a State that are: (1) Applicable to the same chemical
substance as the rule under TSCA section 6(a); and (2) Designed to
prohibit or otherwise restrict the manufacture, processing, or
distribution in commerce or use of that same chemical. TSCA section
18(c)(3) applies that preemption only to the ``hazards, exposures,
risks, and uses or conditions of use'' of such chemical included in the
final TSCA section 6(a) rule.
EPA provides the following preliminary federalism summary impact
statement. The Agency consulted with State and local officials early in
the process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included
background presentation on September 9, 2020, and a consultation
meeting on July 22, 2021. EPA invited the following national
organizations representing State and local elected officials to these
meetings: American Water Works Association, Association of Clean Water
Administrators, Association of Metropolitan Water Agencies, Association
of State Drinking Water Administrators, Environmental Council of the
States, National Association of Counties, National Conference of State
Legislatures, National Governors Association, National League of
Cities, National Water Resources Association, and United States
Conference of Mayors. During the consultation, stakeholders in
attendance asked about the differences between PCE and TCE, recommended
additional reporting requirements as a risk management tool to address
the unreasonable risk, suggested EPA look into safer alternatives, and
described concerns related to current impacts on drinking water
utilities from PCE (Ref. 25). A summary of the meeting with these
organizations, including the views that they expressed, is available in
the docket (Ref. 25). EPA provided an opportunity for these
organizations to provide follow-up comments in writing but did not
receive any such comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. This rulemaking would not have
substantial direct effects on Tribal governments because PCE is not
manufactured, processed, or distributed in commerce by Tribes. PCE is
not regulated by Tribes, and this rulemaking would not impose
substantial direct compliance costs on Tribal governments. Thus,
Executive Order 13175 does not apply to this action.
Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, EPA consulted with Tribal officials during the
development of this action. The Agency held a Tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15, 2021, and
July 8, 2021. Tribal officials were given the opportunity to
meaningfully interact with EPA risk managers concerning the current
status of risk management. During the consultation, EPA discussed risk
management under TSCA section 6(a), findings from the 2020 Risk
Evaluation for PCE, types of information to inform risk management,
principles for transparency during risk management, and types of
information EPA is seeking from Tribes (Ref. 26). EPA briefed Tribal
officials on the Agency's risk management considerations and encouraged
Tribal officials to provide additional comments after the
teleconferences. Tribal officials raised no related issues or concerns
to EPA during or in follow-up to those meetings (Ref. 26).
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866, and because EPA does not
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children as reflected by the
conclusions of the PCE risk evaluation. This action's health and risk
assessments are contained in Unit III.A.3, III.B.2, VI.A. and B., and
the 2020 Risk Evaluation for PCE and the Economic Analysis for this
proposed rulemaking (Refs. 1 and 3).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not been designated by the Administrator of the Office
of Information and Regulatory Affairs as a significant energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to PCE.
Consistent with the Agency's Performance Based Measurement System
(PBMS), the Agency proposes not to require the use of specific,
prescribed analytic methods. Rather, the Agency plans to allow the use
of any method that meets the prescribed performance criteria. The PBMS
approach is intended to be more flexible and cost-effective for the
regulated community; it is also intended to encourage innovation in
analytical technology and improved data quality. EPA is not precluding
the use of any method, whether it constitutes a voluntary consensus
standard or not, as long as it meets the performance criteria
specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
PCE at the ECEL and the ECEL action level. Some examples of methods
which meet the criteria are included in appendix B of the ECEL memo
(Ref. 10). EPA recognizes that there may be voluntary consensus
standards that meet the proposed criteria (Ref. 81). EPA requests
comments on whether it should incorporate such voluntary consensus
standards in the rule and seeks information in support of such comments
regarding the availability and applicability of voluntary consensus
standards that may achieve the sampling and analytical requirements of
the rule in lieu of the PBMS approach.
[[Page 39716]]
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make EJ part of their mission by identifying and addressing, as
appropriate, disproportionately high and adverse human health or
environmental effects of their programs, policies, and activities on
minority populations (people of color and/or indigenous peoples) and
low-income populations.
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations and/or
indigenous peoples. As described more fully in the Economic Analysis,
EPA conducted an analysis to characterize the baseline conditions faced
by communities and workers affected by the regulation to identify the
potential for disproportionate impacts on minority and low-income
populations. The baseline characterization suggests that workers in
affected industries and regions, as well as residents of nearby
communities, are more likely to be people of color than the general
population in affected states, although this varied by use assessed.
Additionally, based on reasonably available information, the Agency
understands that most dry cleaning workers are members of minority
populations.
EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on people of color, low-income
populations and/or Indigenous peoples. While the regulatory options are
anticipated to address the unreasonable risk from exposure to PCE to
the extent necessary so that it is no longer unreasonable, EPA is not
able to quantify the distribution of the change in risk across affected
workers, communities, or demographic groups. EPA is also unable to
quantify the changes in risks to workers, communities, and demographic
groups from non-PCE-using technologies or practices that firms may
adopt in response to the regulation to determine whether any such
changes could pose EJ concerns. Data limitations that prevent EPA from
conducting a more comprehensive analysis are summarized in the Economic
Analysis (Ref. 3).
EPA additionally identified and addressed EJ concerns by conducting
outreach to advocates of communities that might be subject to
disproportionate exposure to PCE, such as minority populations, low-
income populations and indigenous peoples. On June 16, 2021, and July
6, 2021, EPA held public meetings as part of this consultation (Ref.
32). See also Unit III.A.1. These meetings were held pursuant to and in
compliance with Executive Order 12898 and Executive Order 14008,
entitled ``Tackling the Climate Crisis at Home and Abroad'' (86 FR
7619, February 1, 2021).
Following the EJ meetings, EPA received five written comments, in
addition to oral comments provided during the consultations. In
general, commenters supported strong outreach to affected communities,
encouraged EPA to follow the hierarchy of controls, favored
prohibitions, and noted the uncertainty, and in some cases inadequacy,
of PPE. Commenters also urged the EPA to extend the rulemaking into
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 economic impacts and a financial program to
offset transition costs to local communities.
The information supporting the review under Executive Order 12898
is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic
Analysis (Ref. 3). EPA's presentations and fact sheets for the EJ
consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of
the consultation are also available in the public docket for this
rulemaking (Ref. 32).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 751 as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4)
0
2. Amend Sec. 751.5 by adding in alphabetical order definitions for
``Authorized person'', ``Direct dermal contact'', ``ECEL'', ``Exposure
group'', ``Owner or operator'', ``Potentially exposed person'',
``Regulated area'', and ``Retailer'' to read as follows:
Sec. 751.5 Definitions.
* * * * *
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
* * * * *
Direct dermal contact means direct handling of a chemical substance
or mixture or skin contact with surfaces that may be contaminated with
a chemical substance or mixture.
ECEL is an Existing Chemical Exposure Limit and means an airborne
concentration generally calculated as an eight (8)-hour time-weighted
average (TWA).
* * * * *
Exposure group means a group consisting of every person performing
the same or substantially similar operations in each work shift, in
each job classification, in each work area where exposure to chemical
substances or mixtures is reasonably likely to occur.
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
* * * * *
Potentially exposed person means any person who may be
occupationally exposed to a chemical substance or mixture in a
workplace as a result of a condition of use of that chemical substance
or mixture.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the ECEL or the EPA Short-Term Exposure Limit (STEL).
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or
[[Page 39717]]
distribution. Any distributor with at least one consumer end user
customer is considered a retailer. A person who distributes in commerce
or makes available a chemical substance or mixture solely to commercial
or industrial end users or solely to commercial or industrial
businesses is not considered a retailer.
0
3. Add subpart G to read as follows:
Subpart G--Perchloroethylene
Sec.
751.601 General.
751.603 Definitions.
751.605 Prohibitions of manufacturing, processing, distribution in
commerce, and use.
751.607 Workplace Chemical Protection Program.
751.609 Workplace requirements for laboratory use.
751.611 Downstream notification.
751.613 Recordkeeping requirements.
751.615 Exemptions.
Subpart G--Perchloroethylene
Sec. 751.601 General.
This subpart establishes prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of perchloroethylene (CASRN 127-18-4), also known as
tetrachloroethylene, to prevent unreasonable risk of injury to health
in accordance with TSCA section 6(a).
Sec. 751.603 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec. 751.611 and 751.613.
ECEL action level means a concentration of airborne
perchloroethylene of 0.07 part per million (ppm) calculated as an eight
(8)-hour time-weighted average (TWA).
3rd generation machine means a dry-to-dry machine with a
refrigerated condenser, as those terms are defined in 40 CFR part 63,
subpart M.
4th or 5th generation machine means a dry-to-dry machine with a
carbon adsorber and refrigerated condenser, as those terms are defined
in 40 CFR part 63, subpart M.
Sec. 751.605 Prohibitions of manufacturing, processing, distribution
in commerce, and use.
(a) Applicability. The provisions of this section apply to the
following uses as indicated in each paragraph of this section:
(1) All consumer use, excluding use of clothing and articles that
have been commercially dry cleaned with perchloroethylene.
(2) Processing into formulation, mixture or reaction product in
other chemical products and preparations.
(3) Dry cleaning use, including:
(i) Industrial and commercial use in dry cleaning and related spot
cleaning in 3rd generation machines; and
(ii) Industrial and commercial use in dry cleaning and related spot
cleaning in 4th and 5th generation machines.
(4) All other industrial and commercial use, except for the
following:
(i) Those industrial and commercial uses presented in Sec.
751.607(a);
(ii) Laboratory use as described in Sec. 751.609(a); and
(iii) Any industrial and commercial use of clothing and articles
that have been commercially dry cleaned with perchloroethylene.
(5) Distribution in commerce.
(b) Prohibitions. (1) After [DATE 12 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are
prohibited from manufacturing (including importing) perchloroethylene
for the uses listed in paragraphs (a)(1), (2) and (4) of this section.
(2) After [DATE 15 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
processing perchloroethylene, including any perchloroethylene-
containing products, for the uses listed in paragraphs (a)(1), (2) and
(4) of this section.
(3) After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products,
to retailers for any use, other than commercial dry cleaning or
consumer use of clothing and articles that have been commercially dry
cleaned with perchloroethylene.
(4) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all retailers are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products.
Distribution in commerce by retailers of clothing and articles that
have been commercially dry cleaned with perchloroethylene is not
subject to the prohibitions described in this paragraph.
(5) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products,
for the uses described in paragraphs (a)(1) and (4) of this section.
(6) After [DATE 24 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
industrial or commercial use of perchloroethylene, including any
perchloroethylene-containing products, for the uses listed in paragraph
(a)(4) of this section.
(7) All persons are prohibited from industrial or commercial use of
perchloroethylene in dry cleaning machines acquired after [DATE 6
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER].
(8) After [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER], all persons are prohibited from industrial or
commercial use of perchloroethylene for the use listed in paragraph
(a)(3)(i) of this section.
(9) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the
manufacturing (including importing), processing, distribution in
commerce, or industrial or commercial use of perchloroethylene for dry
cleaning and spot cleaning, including for the use listed in paragraph
(a)(3)(ii) of this section.
(c) De minimis level. Products containing perchloroethylene at
levels less than 0.1 percent by weight are not subject to the
prohibitions described in paragraph (b) of this section.
Sec. 751.607 Workplace chemical protection program.
(a) Applicability. The provisions of this section apply to
workplaces engaged in the following conditions of use of
perchloroethylene, unless otherwise indicated in this section, except
to the extent the conditions of use are prohibited by Sec. 751.605:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing as a reactant/intermediate;
(4) Processing into formulation, mixture or reaction product in
paint and coating products;
[[Page 39718]]
(5) Processing into formulation, mixture or reaction product in
cleaning and degreasing products;
(6) Processing into formulation, mixture or reaction product in
adhesive and sealant products
(7) Repackaging;
(8) Industrial and commercial use as solvent for open-top batch
vapor degreasing;
(9) Industrial and commercial use as solvent for closed-loop batch
vapor degreasing;
(10) Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
(11) Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
(12) Industrial and commercial use in maskant for chemical milling;
(13) Industrial and commercial use in solvent-based adhesives and
sealants;
(14) Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing;
(15) Recycling; and
(16) Disposal.
(b) Existing chemical exposure limit (ECEL)--(1) Applicability. The
provisions of this paragraph (b) apply to any workplace engaged in a
condition of use that is listed in paragraphs (a)(1) through (14) of
this section and not prohibited by Sec. 751.605.
(2) Eight-hour time-weighted average (TWA) ECEL. Beginning [DATE 9
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], or beginning 4 months after introduction of
perchloroethylene into the workplace if perchloroethylene use commences
after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER], the owner or operator must ensure that no person is
exposed to an airborne concentration of perchloroethylene in excess of
0.14 parts of perchloroethylene per million parts of air (0.14 ppm) as
an eight (8)-hour TWA, in accordance with the requirements of paragraph
(d)(1)(i) of this section and, if necessary, paragraph (f) of this
section.
(3) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each person whose exposure must be
monitored.
(B) Representative 8-hour TWA exposures must be determined on the
basis of one or more full-shift exposure of at least one person that
represents, and does not underestimate, the potential exposure of every
person in each exposure group and that represents the highest
perchlorethylene exposures likely to occur under reasonably foreseeable
conditions of use.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice Standards in 40 CFR part 792.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of perchloroethylene.
(E) Owners and operators must re-monitor within 15 working days
after receipt 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.
(ii) Initial monitoring. (A) Each owner or operator who has a
workplace or work operation covered by this section, except as provided
for in paragraph (b)(3)(ii)(B) of this section, must perform initial
monitoring of potentially exposed persons regularly working in areas
where perchloroethylene is present.
(B) The initial monitoring required in paragraph (b)(3)(ii)(A) of
this section must be completed by [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or within 30
days of introduction of perchloroethylene into the workplace, whichever
is later. Where the owner or operator has monitoring within five years
prior to [the effective date of the final rule] and the monitoring
satisfies all other requirements of this section, the owner or operator
may rely on such earlier monitoring results to satisfy the requirements
of paragraph (b)(3)(ii)(A) of this section.
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
perchloroethylene in accordance with table 1 to this paragraph
(b)(3)(iii).
Table 1 to Sec. 751.607(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below 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
is required but does not manufacture, event. However, documentation
process, use, or dispose of of cessation of use of
perchlorethylene in that condition of perchlorethylene is required;
use over the entirety of time since and periodic monitoring would
the last required monitoring event. be required when the owner or
operator resumes the condition
of use.
------------------------------------------------------------------------
(iv) Additional monitoring. (A) The owner or operator must conduct
additional initial exposure monitoring whenever there has been a change
in the production, process, control equipment, personnel or work
practices that may reasonably be expected to result in new or
additional exposures above the ECEL action level or when the owner or
operator has any reason to believe that new or additional exposures
above the ECEL action level have occurred.
(B) Whenever start-ups, shutdown, spills, leaks, ruptures or other
breakdowns occur that may lead to
[[Page 39719]]
exposure to potentially exposed persons, the owner or operator must
conduct additional initial exposure monitoring (using personal
breathing zone sampling) after the cleanup of the spill or repair of
the leak, rupture or other breakdown.
(v) Notification of monitoring results. (A) The owner or operator
must inform persons whose exposures are represented by the monitoring
of the monitoring results within 15 working days.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level in plain language;
(3) Explanation of any corresponding required respiratory
protection as described in paragraph (f) of this section;
(4) Descriptions of actions taken by the regulated entity to reduce
exposure to or below the ECEL;
(5) Quantity of perchloroethylene in use;
(6) Location of perchloroethylene use;
(7) Manner of perchloroethylene use;
(8) Identified releases of perchloroethylene; and
(9) Whether the airborne concentration of perchloroethylene exceeds
the ECEL limit.
(C) Notice must be provided in plain language writing, in a
language that the person understands, to each potentially exposed
person or posted in an appropriate and accessible location outside the
regulated area with an English-language version and a non-English
language version representing the language of the largest group of
workers who do not read English.
(4) Regulated areas. (i) Beginning [DATE 9 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or beginning 4
months after introduction of perchloroethylene into the workplace if
perchloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or
operator must establish and maintain a regulated area wherever any
person's exposure to airborne concentrations of perchloroethylene
exceeds or can reasonably be expected to exceed the ECEL.
(ii) The owner or operator must limit access to regulated areas to
authorized persons.
(iii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the area and minimizes the number
of authorized persons exposed to perchloroethylene within the regulated
area.
(iv) The owner or operator must supply a respirator that complies
with the requirements of paragraph (f) of this section and must ensure
that all persons within the regulated area are using the provided
respirators whenever perchloroethylene exposures may exceed the ECEL.
(v) An owner or operator who has implemented all feasible
engineering, work practice and administrative controls as required in
paragraph (d)(1)(i) of this section, and who has established a
regulated area as required by paragraph (b)(4)(i) of this section where
perchloroethylene exposure can be reliably predicted to exceed the ECEL
only on certain days (for example, because of work or process schedule)
must have persons use respirators in that regulated area on those days.
(vi) The owner or operator must ensure that, within a regulated
area, persons do not engage in non-work activities which may increase
perchloroethylene exposure.
(vii) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities which interfere with respirator seal or performance.
(c) Direct dermal contact controls. (1) The provisions of this
paragraph (c) apply to any workplace engaged in the conditions of use
that are listed in paragraphs (a)(1) through (16) of this section and
are not prohibited by Sec. 751.605.
(2) Owners or operators must ensure that all persons are separated,
distanced, physically removed, or isolated from direct dermal contact
with perchloroethylene in accordance with the requirements of paragraph
(d)(1)(ii) of this section and, if necessary, paragraph (f) of this
section.
(d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) The owner or operator must institute one or a
combination of elimination, substitution, engineering controls or
administrative controls to reduce exposure to or below the ECEL except
to the extent that the owner or operator can demonstrate that such
controls are not feasible.
(B) Wherever the feasible exposure controls, including one or a
combination of elimination, substitution, engineering controls or
administrative controls, which can be instituted are not sufficient to
reduce exposure to or below the ECEL, the owner or operator must use
them to reduce exposure to the lowest levels achievable by these
controls and must supplement them by the use of respiratory protection
that complies with the requirements of paragraph (f) of this section.
Where an owner or operator cannot demonstrate exposure below the ECEL,
including through the use of engineering controls or work practices,
and has not demonstrated that it has supplemented feasible exposure
controls with respiratory protection that complies with the
requirements of paragraph (f) of this section, this will constitute a
failure to comply with the ECEL.
(C) The owner or operator must maintain the effectiveness of
engineering controls and administrative controls instituted under
paragraph (d)(1)(i)(A) of this section.
(D) The owner or operator must not implement a schedule of
personnel rotation as a means of compliance with the ECEL.
(E) The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (d)(2) of this section.
(ii) Direct dermal contact control requirements. (A) The owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with perchloroethylene
except to the extent that the owner or operator can demonstrate that
such controls are not feasible.
(B) Wherever the feasible exposure controls, including one or a
combination of elimination, substitution, engineering controls or
administrative controls, which can be instituted are not sufficient to
prevent direct dermal contact, the owner or operator must use them to
reduce direct dermal contact to the extent achievable by these controls
and must supplement them by the use of dermal personal protective
equipment that complies with the requirements of paragraph (f) of this
section. Where an owner or operator cannot demonstrate direct dermal
contact is prevented, including through the use of engineering controls
or work practices, and has not demonstrated that it has supplemented
feasible exposure controls with dermal personal protective equipment
that complies with the requirements of paragraph (f) of this section,
this will constitute a failure to comply with the direct dermal contact
control requirements.
(C) The owner or operator must maintain the effectiveness of
engineering controls and administrative
[[Page 39720]]
controls instituted under paragraph (d)(1)(ii)(A) of this section.
(D) The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (d)(2) of this section.
(2) Exposure control plan requirements. Beginning [DATE 12 MONTHS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER],
owners and operators must include and document in an exposure control
plan the following:
(i) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of perchloroethylene,
substitution of perchloroethylene, engineering controls and
administrative controls to reduce exposures in the workplace to either
at or below the ECEL or to the lowest level achievable and to prevent
or reduce direct dermal contact with perchloroethylene in the
workplace;
(ii) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(iii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(iv) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(v) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL;
(vi) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(vii) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or any direct dermal contact with perchloroethylene and
subsequent corrective actions taken during start-up, shutdown, or
malfunctions to mitigate exposures to perchloroethylene; and
(viii) Availability of the exposure control plan and associated
records for potentially exposed persons.
(e) Workplace information and training. (1) The owner or operator
must provide information and training for each person prior to or at
the time of initial assignment to a job involving potential exposure to
perchloroethylene.
(2) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(3) The following information and training must be provided to all
persons assigned to a job involving potential exposure to
perchloroethylene:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
perchloroethylene and the specific operations in the workplace that
could result in exposure to perchloroethylene, particularly noting
where exposures may be above the ECEL or where there is potential for
direct dermal contact with perchloroethylene;
(iii) Methods and observations that may be used to detect the
presence or release of perchloroethylene in the workplace (such as
monitoring conducted by the owner or operator, continuous monitoring
devices, visual appearance or odor of perchloroethylene when being
released, etc.);
(iv) The health hazards of perchloroethylene in the workplace; and
(v) The principles of safe use and handling of perchloroethylene
and measures potentially exposed persons can take to protect themselves
from perchloroethylene, including specific procedures the owner or
operator has implemented to protect potentially exposed persons from
exposure to perchloroethylene, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
(4) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of
perchloroethylene in the workplace.
(5) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures,
which increase exposure, and where those exposures exceed or can
reasonably be expected to exceed the ECEL action level or increase
potential for direct dermal contact, the owner or operator must update
the training as necessary to ensure that each potentially exposed
person has the requisite proficiency.
(f) Personal protective equipment (PPE). (1) The provisions of this
paragraph (f) apply to any owner or operator that is required to
provide respiratory protection or dermal protection pursuant to
paragraph (d)(1)(i)(B) or (d)(1)(ii)(B) of this section or Sec.
751.609(b)(2).
(2) PPE, including respiratory and dermal protection, that is of
safe design and construction for the work to be performed must be
provided, used, and maintained in a sanitary, reliable, and undamaged
condition. Owners and operators must select PPE that properly fits each
affected person and communicate PPE selections to each affected person.
(3) Owners and operators must provide PPE training in accordance
with 29 CFR 1910.132(f) to all persons required to use PPE prior to or
at the time of initial assignment to a job involving potential exposure
to perchloroethylene. For the purposes of this paragraph (f)(3),
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(4) Owners and operators must retrain each potentially exposed
person required to use PPE annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use PPE, or when
changes in the workplace or in PPE to be used render the previous
training obsolete.
(5) Respiratory protection. (i) Beginning [DATE 9 MONTHS AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or within 3
months after receipt of any exposure monitoring that indicates
exposures exceeding the ECEL, the owner or operator must supply a
respirator, selected in accordance with this paragraph, to each person
who enters a regulated area and must ensure that all persons within the
regulated area are using the provided respirators whenever
perchloroethylene exposures may exceed the ECEL.
(ii) Owners or operators must provide respiratory protection in
accordance with the provisions outlined in 29 CFR 1910.134(a) through
(l) (except paragraph (d)(1)(iii)) and as specified in this paragraph
for persons exposed or who may be exposed to perchloroethylene in
concentrations above the ECEL. For the purpose of this paragraph (f),
the maximum use concentration (MUC) as used in 29 CFR 1910.134 must be
calculated by multiplying the assigned protection factor (APF)
specified for a respirator by the ECEL. For the purposes of this
paragraph (f)(5)(ii), provisions in 29 CFR 1910.134(a) through (l)
(except paragraph (d)(1)(iii)) applying to an ``employee'' also apply
equally to potentially exposed persons, and
[[Page 39721]]
provisions applying to an ``employer'' also apply equally to owners or
operators.
(iii) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below 0.14 ppm:
no respiratory protection is required.
(B) If the measured exposure concentration is above 0.14 ppm and
less than or equal to 0.7 ppm (5 times ECEL): Any National Institute
for Occupational Safety and Health (NIOSH)-certified air-purifying
quarter mask respirator (APF 5).
(C) If the measured exposure concentration is above 0.7 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).
(D) 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).
(E) 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).
(F) 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).
(G) 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 equipped with a full facepiece and
operated in a pressure demand or other positive pressure mode; or any
NIOSH-certified supplied air respirator equipped with a full facepiece
and operated in a pressure demand or other positive pressure mode in
combination with an auxiliary self-contained breathing apparatus
operated in a pressure demand or other positive pressure mode (APF
10,000).
(iv) The respiratory protection requirements in this paragraph
represent the minimum respiratory protection requirements, such that
any respirator affording a higher degree of protection than the
required respirator may be used.
(v) When a person whose job requires the use of a respirator cannot
use a negative-pressure respirator, the owner or operator must provide
that person with a respirator that has less breathing resistance than
the negative-pressure respirator, such as a powered air-purifying
respirator or supplied-air respirator, when the person is able to use
it and if it provides the person with adequate protection.
(6) Dermal protection. (i) The owner or operator must supply and
require the donning of dermal PPE that separates and provides a barrier
to prevent direct dermal contact with perchloroethylene in the specific
work area where it is selected for use, selected in accordance with
this paragraph (f)(6)(i) and provided in accordance with 29 CFR
1910.132(h), to each person who is reasonably likely to be dermally
exposed in the work area through direct dermal contact with
perchloroethylene. For the purposes of this paragraph (f)(6)(i),
provisions in 29 CFR 1910.132(h) applying to an ``employer'' also
applies equally to owners or operators.
(ii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in
this paragraph to each person who is reasonably likely to be dermally
exposed in the work area through direct dermal contact with
perchloroethylene. For the purposes of this paragraph (f)(6)(ii),
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply
equally to owners or operators.
(iii) Owners or operators must select and provide to persons
appropriate 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. Dermal PPE must include,
but is not limited to, the following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(iv) Demonstration of imperviousness. Owners or operators must
demonstrate that each item of gloves and other clothing selected
provides an impervious barrier to prevent direct dermal contact with
perchloroethylene during normal and expected duration and conditions of
exposure within the work area by evaluating the specifications from the
manufacturer or supplier of the clothing, or of the material used in
construction of the clothing, to establish that the clothing will be
impervious to perchloroethylene alone and in likely combination with
other chemical substances in the work area.
Sec. 751.609 Workplace requirements for laboratory use.
(a) Applicability. The provisions of this section apply to
workplaces engaged in the industrial and commercial use of
perchloroethylene as a laboratory chemical.
(b) Laboratory use requirements. (1) After [DATE 12 MONTHS AFTER
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], owners
or operators must ensure fume hoods are in use and functioning properly
and that specific measures are taken to ensure proper and adequate
performance of such equipment to minimize exposures to persons in the
area when perchloroethylene is used in a laboratory setting.
(2) After [DATE 12 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], owners or operators must ensure that all
persons reasonably likely to be exposed from direct dermal contact to
perchloroethylene in a laboratory setting are provided with dermal
personal protective equipment as outlined in Sec. 751.607(f)(2) and
(6) and training on proper use of PPE as outlined in Sec.
751.607(f)(3) and (4).
Sec. 751.611 Downstream notification.
(a) Beginning on [DATE 2 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], each person who manufactures
(including imports) perchloroethylene for any use must, prior to or
concurrent with the shipment, notify companies to whom
perchloroethylene is shipped, in writing, of the restrictions described
in this subpart in accordance with paragraph (c) of this section.
(b) Beginning on [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], each person who processes or
distributes in commerce perchloroethylene or any perchloroethylene-
containing products for any use must, prior to or concurrent
[[Page 39722]]
with the shipment, notify companies to whom perchloroethylene is
shipped, in writing, of the restrictions described in this subpart in
accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in section 1(c) and
15 of the Safety Data Sheet (SDS) provided with the perchloroethylene
or with any perchloroethylene-containing product:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be
distributed in commerce to retailers for any use. After [DATE 21
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], this chemical/product is and can only be distributed in
commerce or processed for the following purposes: Processing as a
reactant/intermediate; Processing into formulation, mixture or
reaction product in cleaning and vapor degreasing products;
Processing into formulation, mixture or reaction product in paint
and coating products; Processing into formulation, mixture or
reaction product in adhesive and sealant products; Processing by
repackaging; Recycling; Industrial and commercial use as solvent in
vapor degreasing; Industrial and commercial use in maskant for
chemical milling; Industrial and commercial use as a processing aid
in catalyst regeneration in petrochemical manufacturing; Industrial
and commercial use in laboratory chemicals; Industrial and
commercial use in solvent-based adhesives and sealants; Industrial
and commercial use in dry cleaning in 3rd generation machines until
[DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER]; Industrial and commercial use in all dry cleaning
and related spot cleaning until [DATE 10 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER]; and
Disposal.
Sec. 751.613 Recordkeeping requirements.
(a) General records. After [DATE 60 DAYS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons who
manufacture, process, distribute in commerce, or engage in industrial
or commercial use of perchloroethylene or perchloroethylene-containing
products must maintain ordinary business records, such as downstream
notifications, invoices and bills-of-lading related to compliance with
the prohibitions, restrictions, and other provisions of this subpart.
(b) Workplace Chemical Protection Program compliance. (1) ECEL
exposure monitoring. For each monitoring event, owners or operators
subject to the ECEL described in Sec. 751.607(b) must document the
following:
(i) Dates, duration, and results of each sample taken;
(ii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iii) 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
(iv) Use of appropriate sampling and analytical methods, such as
analytical methods already approved by EPA, Occupational Safety and
Health Administration (OSHA) or NIOSH, or compliance with an analytical
method verification procedure;
(v) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792; and
(vi) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.607(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.607(d)(2);
(ii) Facility exposure monitoring records;
(iii) Notifications of exposure monitoring results;
(iv) The name, workplace address, work shift, job classification,
work area and respiratory protection used by each potentially exposed
person and PPE program implementation as described in Sec. 751.607(f),
including fit-testing and training; and
(v) Information and training provided by the regulated entity to
each person prior to or at the time of initial assignment to a job
involving potential exposure to perchloroethylene and any re-training
as required in Sec. 751.607(e).
(3) DDCC compliance. Owners or operators subject to DDCC
requirements described in Sec. 751.607(c) must retain records of:
(i) Exposure control plan as described in Sec. 751.607(d);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.607(f), including:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to directly handle
perchloroethylene or handle equipment or materials on which
perchloroethylene 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
perchloroethylene that occurs during any activity or malfunction at the
workplace that causes direct dermal exposures to occur and/or glove
breakthrough, and corrective actions to be taken during and immediately
following that activity or malfunction to prevent direct dermal contact
to perchloroethylene; and
(E) Training in accordance with Sec. 751.607(f)(3).
(iii) Information and training provided by the regulated entity to
each person prior to or at the time of initial assignment to a job
involving potential direct dermal contact with perchloroethylene and
any re-training as required in Sec. 751.607(e).
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person that may
reasonably be affected by perchloroethylene inhalation exposure or
direct dermal contact to readily access the exposure control plans,
facility exposure monitoring records, PPE program implementation, or
any other information relevant to perchloroethylene exposure in the
workplace.
(c) Workplace requirements for laboratory use compliance. Owners
and operators subject to the laboratory chemical requirements described
in Sec. 751.609 must retain records of:
(1) Dermal protection used by each potentially exposed person and
PPE program implementation, as described in Sec. 751.613(b)(3)(ii);
and
(2) Documentation identifying: implementation of a properly
functioning fume hood using manufacturer's instructions for
installation, use, and maintenance of the fume hood, including
inspections, tests, development of maintenance procedures, the
establishment of criteria for acceptable test results, and
documentation of test and inspection results.
(d) Records related to Sec. 751.615 exemptions. To maintain
eligibility for an exemption described in Sec. 751.615,
[[Page 39723]]
the records maintained by the owners or operators must demonstrate
compliance with the specific conditions of the exemption.
(e) Retention. Owners or operators must retain the records required
under this section for a period of 5 years from the date that such
records were generated.
Sec. 751.615 Exemptions.
(a) In general. (1) As provided in paragraph (b) of this section, a
time-limited exemption from the requirements of Sec. 751.605 is
established in this section in accordance with 15 U.S.C. 2605(g)(1)(A).
(2) In order to be eligible for the exemptions established in this
section, regulated parties must comply with all conditions established
for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Time-limited exemption. Use of perchloroethylene or
perchloroethylene containing products identified in paragraph (b)(1) of
this section in an emergency by the National Aeronautics and Space
Administration and its contractors operating within the scope of their
contracted work until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER].
(1) Applicability. The emergency use exemption described in this
paragraph (b) shall apply to the following specific conditions of use
as described in paragraph (b)(1)(i) of this section.
(i) Conditions of use subject to this exemption. (A) Industrial and
commercial use as solvent for cold cleaning.
(B) Industrial and commercial use in wipe cleaning.
(ii) Emergency use--(A) In general. An emergency is a serious and
sudden situation requiring immediate action, within 15 days or less,
necessary to protect:
(1) Safety of National Aeronautics and Space Administration's or
their contractors' personnel;
(2) National Aeronautics and Space Administration's missions;
(3) Human health, safety, or property, including that of adjacent
communities; or
(4) The environment.
(B) Duration. Each emergency is a separate situation; if use of
perchloroethylene exceeds 15 days, then justification must be
documented.
(C) Eligibility. To be eligible for the exemption, the National
Aeronautics and Space Administration and its contractors must:
(1) Select perchloroethylene because there are no technically and
economically feasible safer alternatives available during the
emergency.
(2) Perform the emergency use of perchloroethylene at locations
controlled by National Aeronautics and Space Administration or its
contractors.
(2) Requirements. To be eligible for the emergency use exemption
described in this paragraph (b), the National Aeronautics and Space
Administration and its contractors must comply with the following
conditions:
(i) Notification. Within 15 working days of the emergency use by
National Aeronautics and Space Administration and its contractors,
National Aeronautics and Space Administration must provide notice to
EPA that includes the following:
(A) Identification of the conditions of use detailed in paragraph
(b)(1)(i) of this section that the emergency use fell under;
(B) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(1)(ii)(A) of this section; and
(C) An explanation of why perchloroethylene was selected, including
why there were no technically and economically feasible safer
alternatives available in the particular emergency.
(ii) Exposure control. The owner or operator must comply with the
Workplace Chemical Protection Program provisions in Sec. 751.607, to
the extent technically feasible in light of the particular emergency.
(iii) Recordkeeping. The owner or operator of the location where
the use takes place must comply with the recordkeeping requirements in
Sec. 751.613.
[FR Doc. 2023-12495 Filed 6-15-23; 8:45 am]
BILLING CODE 6560-50-P