[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Rules and Regulations]
[Pages 103560-103616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30117]
[[Page 103559]]
Vol. 89
Wednesday,
No. 243
December 18, 2024
Part IX
Environmental Protection Agency
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40 CFR Part 751
Perchloroethylene (PCE); Regulation Under the Toxic Substances Control
Act (TSCA); Final Rule
Federal Register / Vol. 89 , No. 243 / Wednesday, December 18, 2024 /
Rules and Regulations
[[Page 103560]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0720; FRL-8329-01-OCSPP]
RIN 2070-AK84
Perchloroethylene (PCE); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing a rule to address the unreasonable risk of injury to health
presented by perchloroethylene (PCE) under its conditions of use. TSCA
requires that EPA address by rule any unreasonable risk of injury to
health or the environment identified in a TSCA risk evaluation and
apply requirements to the extent necessary so that the chemical no
longer presents unreasonable risk. EPA's final rule will, among other
things, prevent serious illness associated with uncontrolled exposures
to the chemical by preventing consumer access to the chemical,
restricting the industrial and commercial use of the chemical while
also allowing for a reasonable transition period where the industrial
and commercial use of the chemical is being prohibited, providing a
time-limited exemption for a critical or essential use of PCE for which
no technically and economically feasible safer alternative is
available, and protecting workers from the unreasonable risk of PCE
while on the job.
DATES: This final rule is effective on January 17, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0720, is available online
at https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Kelly Summers, Existing Chemicals Risk
Management Division (7405M), 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: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620-1103; telephone number: (202) 554-
1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
1. General Applicability
You may be affected by this rule if you manufacture, process,
distribute in commerce, use, or dispose of PCE or products containing
PCE. TSCA section 3(9) defines the term ``manufacture'' to mean ``to
import into the customs territory of the United States (as defined in
general note 2 of the Harmonized Tariff Schedule of the United States),
produce, or manufacture.'' Therefore, unless expressly stated
otherwise, importers of PCE are subject to provisions regulating
manufacture of 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 might apply 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).
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).
[[Page 103561]]
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).
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).
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2. Applicability to Importers and Exporters.
This action may also affect certain entities subject to import
certification and export notification requirements under TSCA (https://www.epa.gov/tsca-import-export-requirements). Persons who import any
chemical substance in bulk form, as part of a mixture, or as part of an
article (if required by rule) are subject to TSCA section 13 (15 U.S.C.
2612) import certification requirements and the corresponding
regulations at 19 CFR 12.118 through 12.127 (see also 19 CFR
127.28(i)). Those persons must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA (see 19 CFR 12.121). The EPA policy in support of import
certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this final rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D. Any person who exports or intends to export
PCE must comply with the export notification requirements in 40 CFR
part 707, subpart D.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the Agency
determines through a TSCA section 6(b) risk evaluation that a chemical
substance presents an unreasonable risk of injury to health or the
environment, EPA must by rule apply one or more requirements listed in
TSCA section 6(a) to the extent necessary so that the chemical
substance or mixture no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined 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). A description of the conditions of use that contribute
to EPA's determination that PCE presents an unreasonable risk is in
Unit III.B.1. of the 2023 PCE proposed rule, with a summary in Unit
II.C.4. of this final rule. Accordingly, to address the unreasonable
risk, EPA is finalizing a rule 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.D.1.;
(ii) Prohibit the manufacture (including import), processing, and
distribution in commerce of PCE for all consumer use, outlined in Unit
IV.D.2.;
(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.D.3.;
(iv) Require a Workplace Chemical Protection Program (WCPP),
including an inhalation exposure concentration limit, direct dermal
contact controls, and related workplace exposure controls, for many
occupational conditions of use of PCE not prohibited, outlined in Unit
IV.B.;
(v) Require prescriptive workplace controls for use of PCE in
laboratories and energized electrical cleaners, outlined in Unit IV.C.;
(vi) Establish recordkeeping and downstream notification
requirements, outlined in Unit IV.E.;
(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 (NASA) 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.F.; and
(viii) Identify a regulatory threshold for products containing PCE
for the prohibitions and restrictions on PCE, as outlined in Unit IV.A.
EPA notes that all TSCA conditions of use of PCE are subject to
this final rule. ``Conditions of use'' is defined in TSCA section 3(4)
to mean the circumstances, as determined by EPA, under which a chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of.
In addition, EPA is amending the general provision of 40 CFR part
751, subpart A, to define ``Designated representative,'' ``Direct
dermal contact,'' ``ECEL,'' and ``Exposure group'' 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.
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. On June 16, 2023, EPA issued a
proposed rule (88 FR 39652) (FRL-8329-02-OCSPP)) under TSCA section
6(a) to regulate PCE, so that it no longer presents unreasonable risk
(hereinafter ``2023 PCE proposed rule''). The Agency received public
comment on the proposal. With this action, EPA is finalizing with
modifications the 2023 PCE proposed rule as described in this final
rule. The conditions of use that contribute to the unreasonable risk
from PCE are described in Unit III.B.1. of the 2023 PCE proposed rule.
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
rule is neurotoxicity from chronic exposure. It was selected 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. 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,
[[Page 103563]]
reproductive toxicity, developmental toxicity, and cancer. For this
action, 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 final rule will 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.
Although EPA is prohibiting many conditions of use of the chemical
where it cannot be used without continuing to present unreasonable risk
as described in Unit IV., EPA is not finalizing 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 final rule allows 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
15-year phasedown under the AIM Act. 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 away from 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. It 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 United States gasoline
pool. Therefore, this final rule allows 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 finalizing 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
(called the existing chemical exposure limit (ECEL)) in this rulemaking
or to prevent direct dermal contact with PCE. For many of the
conditions of use for which EPA is finalizing workplace controls under
a WCPP, data to support the industry's position that certain uses could
meet the exposure limit and ancillary requirements of an effective WCPP
in addressing unreasonable risk were submitted during the risk
evaluation, the Small Business Advocacy Review (SBAR) Panel process,
the comment period following publication of the 2023 PCE proposed rule,
or stakeholder outreach, and are available in the corresponding public
dockets (Docket ID Nos. EPA-HQ-OPPT-2020-0720; EPA-HQ-OPPT-2019-0502;
EPA-HQ-OPPT-2016-0732).
Accordingly, EPA is finalizing workplace controls to address the
unreasonable risk and allow continued manufacture (including import),
processing for conditions of use that are not prohibited, repackaging,
recycling, and disposal of PCE as well as continued use of PCE for
processing as a reactant/intermediate, certain uses in vapor degreasing
and cold cleaning, use as a maskant for chemical milling, use in
adhesives and sealants, use as a processing aid, use as energized
electrical cleaner, and use as a laboratory chemical, which comprise
more than an estimated 80% of the current production volume of PCE. EPA
is finalizing a prohibition or phaseout for most conditions of use of
PCE, including use in dry cleaning and spot cleaning, general 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 are not prohibited, EPA generally
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. The rationale for the final regulatory action, including the
TSCA section 6 requirements considered in developing the regulatory
action, is described in Units II.D. and III.
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 V.D. and VIII.C., EPA was unable to
quantify all incremental costs of this final rule. The quantifiable
cost of the final rule is estimated to be $43.43 million annualized
over 20 years at a 2% discount rate. These costs take compliance with
implementation of a WCPP into consideration, which would include
meeting an 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 Economic Analysis notes various unquantified costs and
uncertainty in the cost estimates (Sec. 7.14). The condition of use
with the most expensive and uncertain compliance costs is the
commercial use of PCE in energized electrical cleaning, which EPA
estimates would result in about $20 million out of $43 million of
estimated compliance costs. These estimates are based on assumptions
regarding how much PCE is used for energized electrical cleaning and
the types of locations of that use. Almost all of these compliance cost
estimates are from respirator requirements for the use of PCE in
energized electrical cleaning in confined spaces, which would require
expensive respirators. Because there is no consensus industry estimate
for what fraction of PCE use in energized electrical cleaning is in
confined spaces, as described in Unit III.A.2.e., EPA estimated 5% of
energized electrical cleaning use of PCE was in confined spaces.
In addition, EPA estimates that 6,000 dry cleaners still use PCE, a
majority of which are small businesses. 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 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 7-11 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 are generalizable to
other states; industry has informed
[[Page 103564]]
the Agency that very few PCE machines have been purchased in recent
years. See sections 7.7 and 11 of the Economic Analysis for additional
detail on EPA's analysis, including uncertainties associated with
estimating the economic impact.
In alignment with the goals of President Biden's Cancer Moonshot,
the rule will protect people from cancer and other adverse health
effects of PCE by prohibiting most uses of PCE while ensuring essential
uses can safely continue (Ref. 4). The actions in this final rule are
expected to achieve health benefits for the American public, some of
which can be monetized and others that, while tangible and significant,
cannot be monetized. The monetized benefits of this rule are
approximately $32.6 million to $84.6 million annualized over 20 years
at a 2% 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
associated with PCE exposure in human studies include visual deficits,
impaired cognition, and neurodevelopmental outcomes from prenatal and
early childhood exposure to PCE such as increased affinity of engaging
in drug, alcohol, and tobacco use as a teen or adult (Ref. 1).
Reductions in PCE exposure therefore may also be associated with
additional important, but currently unmonetized, benefits.
Additionally, the Agency expects that the dry cleaning phaseout
will decrease significant adverse health risks for affected populations
that may own, operate, or work at dry cleaning facilities, as well as
children of workers present at dry cleaners. 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). For the public's
understanding, this document notes that based on reasonably available
information, a significant number of members of minority populations
may own or work at dry cleaning facilities.
II. Background
A. Overview of Perchloroethylene (PCE)
As described in more detail in the 2023 PCE proposed rule, PCE is a
neurotoxicant and considered ``likely to be carcinogenic in humans''.
This final 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 II.C. 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 Unit II.C.4., 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 United States decreased from 388 million pounds to around
324 million pounds between 2012 and 2015 (Ref. 5). The total aggregate
annual production volume ranged from 250 to 500 million pounds between
2016 and 2019 according to CDR (Ref. 6).
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 as other Federal, State, and
international regulations, is in the docket (Refs. 1, 7).
As described in more detail in Unit II.C. of 2023 PCE proposed
rule, and the Response to Public Comments document (Ref. 8), EPA
considered the adequacy of the current occupational safety and health
standards from the Occupational Safety and Health Administration (OSHA)
(29 CFR part 1910) for protection of workers. EPA notes that the
standards for chemical hazards that OSHA promulgates under the
Occupational Safety and Health (OSH) Act share a broadly similar
purpose with the worker protection-related regulations that EPA
promulgates under TSCA section 6(a). The control measures OSHA and EPA
require to satisfy the objectives of their respective statutes may
also, in many circumstances, overlap or coincide. However, there are
important differences between EPA's and OSHA's regulatory approaches
and jurisdiction, and EPA considers these differences when deciding
whether and how to account for OSHA requirements when evaluating and
addressing potential unreasonable risk to workers so that compliance
requirements are clearly explained to the regulated community. TSCA
risk evaluations are subject to statutory science standards, an
explicit requirement to consider risks to potentially exposed or
susceptible subpopulations, and a prohibition on considering costs and
other non-risk factors when determining whether a chemical presents an
unreasonable risk that warrants regulatory actions--all requirements
that do not apply to development of OSHA regulations. As such, EPA may
find unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements. In addition, health standards issued under section
6(b)(5) of the OSH Act must reduce significant risk only to the extent
that it is technologically and economically feasible. OSHA's legal
requirement to demonstrate that its section 6(b)(5) standards are
technologically and economically feasible at the time they are
promulgated often precludes OSHA from imposing exposure control
requirements sufficient to ensure that the chemical substance no longer
presents a significant risk to workers. While it is possible in some
cases that the OSHA standards for some chemicals reviewed under TSCA
will eliminate unreasonable risk, based on EPA's experience thus far in
conducting occupational risk assessments under TSCA, EPA believes that
OSHA chemical standards would in general be unlikely to address
unreasonable risk to workers within the meaning of TSCA, since TSCA
section 6(b) unreasonable risk determinations may account for
unreasonable risk to more sensitive endpoints and working populations
than OSHA's risk evaluations typically contemplate and EPA is obligated
to apply TSCA section 6(a) risk management requirements to the extent
necessary so that the unreasonable risk is no longer presented. Because
the requirements and application of TSCA and OSHA regulatory analyses
differ, it is necessary for EPA to conduct risk evaluations and, where
it finds unreasonable risk to workers, develop risk management
requirements for chemical substances that OSHA also regulates, and it
is expected that EPA's findings and requirements may sometimes diverge
from OSHA's. Additional considerations of OSHA standards in the revised
unreasonable risk determination are discussed further in the 2022
Revised Unreasonable Risk
[[Page 103565]]
Determination for PCE, published in the Federal Register of December
14, 2022 (87 FR 76481 (FRL-9942-02-OCSPP)).
EPA intends for this regulation to be as consistent as possible
with OSHA regulations for toxic and hazardous substances, with
additional requirements as necessary to address the unreasonable risk
identified under TSCA. 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 enforcement of TSCA
while imposing the least burdens of duplicative requirements.
C. Summary of EPA's Risk Evaluation Activities on PCE
EPA published the scope of the PCE risk evaluation in July 2017 (82
FR 31592 (FRL-9963-57)), and, after receiving public comments,
published the problem formulation on June 11, 2018 (83 FR 26998 (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 Evaluation for 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
Risk Determination for PCE in December 2022 (87 FR 76481, December 14,
2022 (FRL-9942-01-OCSPP)). The 2020 Risk Evaluation for PCE and
supplemental materials are in Docket ID No. EPA-HQ-OPPT-2019-0502, and
the December 2022 revised unreasonable risk determination and
additional materials supporting the risk evaluation process in Docket
ID No. EPA-HQ-OPPT-2016-0732.
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 (Ref. 1). Descriptions
of these conditions of use are in Unit III.B.1. of the 2023 PCE
proposed rule. The 2020 Risk Evaluation for PCE identified significant
adverse health effects associated with short- and long-term exposure to
PCE. A further discussion of the hazards of PCE is in Unit III.B.2. of
the 2023 PCE proposed rule.
2. 2022 Revised Unreasonable Risk Determination
As described in more detail in the 2023 PCE proposed rule, 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 (titled
``Protecting Public Health and the Environment and Restoring Science to
Tackle the Climate Crisis'') and other Administration priorities (Refs.
9, 10, and 11). The revisions consisted of making the risk
determination based on the whole-chemical substance instead of making
the risk determination for each individual condition of use, which
resulted in the revised risk determination superseding the prior ``no
unreasonable risk'' determinations for specific conditions of use (Ref.
2), the withdrawal of the associated TSCA section 6(i)(1) ``no
unreasonable risk'' order, and clarification that the risk
determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE (Ref. 2).
EPA determined that PCE presents an unreasonable risk of injury to
health, and EPA did not identify risks of injury to the environment
that contribute to the unreasonable risk determination for PCE. The PCE
conditions of use that contribute to EPA's determination that the
chemical substance poses unreasonable risk to health are listed in the
unreasonable risk determination (Ref. 2) and also in Unit III.B.1. of
the 2023 PCE proposed rule, with descriptions to aid chemical
manufacturers, processors, and users in determining how their
particular use or activity would be addressed under the final
regulatory action.
3. Description of Unreasonable Risk
EPA has determined that PCE presents an unreasonable risk of injury
to health under the conditions of use, based on acute and chronic non-
cancer risks and chronic cancer risks. As described in more detail in
the 2023 PCE proposed rule and as described in the TSCA section 6(b)
2020 Risk Evaluation for PCE, EPA identified non-cancer effects from
both 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). Other adverse effects associated with
exposure to PCE include kidney and liver effects, immune system
toxicity, and developmental toxicity. By targeting the sensitive
chronic neurotoxicity effects endpoint for risk management, EPA's final
rule will also prevent the unreasonable risks from acute, chronic non-
cancer and cancer endpoints associated with inhalation and dermal
exposure to PCE.
EPA considered potentially exposed or susceptible subpopulations
identified as relevant to the risk evaluation by the Agency, which are
included in the quantitative and qualitative analyses described in the
2020 Risk Evaluation for PCE (Ref. 1) and were considered in the
determination of unreasonable risk for PCE.
4. Conditions of Use Subject to This Regulatory Action
As noted in Unit I.C. ``conditions of use'' is defined in TSCA
section 3(4). Condition of use descriptions for PCE are provided in
Unit III.B.1. of the 2023 PCE proposed rule and were obtained from EPA
sources such as CDR codes, the 2020 Risk Evaluation for PCE and related
documents, as well as the Organisation for Economic Co-operation and
Development (OECD) harmonized use codes, and stakeholder engagements.
EPA received public comments requesting minor clarifications of the
descriptions for some industrial and commercial uses, and EPA has
clarified those descriptions in Unit IV. A description of the minor
changes can be found in the response to comments document and in Unit
III.D. (Ref. 8). To assist with the implementation and compliance with
the final rule, in Unit IV., EPA has provided a description of the
conditions of use subject to the WCPP and to prescriptive controls.
As in the 2023 PCE proposed rule, for the purposes of this final
rule, ``occupational conditions of use'' refers to the TSCA conditions
of use described in Units III.B.1.a., b., c., and e. of the 2023 PCE
proposed rule. Although EPA identified both industrial and commercial
uses in the 2020 Risk Evaluation for PCE (Ref. 1) for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority Congress gave to the Agency to
``regulat[e] any
[[Page 103566]]
manner or method of commercial use'' under TSCA section 6(a)(5) to
reach both industrial and commercial uses. Additionally, as described
in the 2023 PCE proposed rule, in the 2020 Risk Evaluation for PCE
(Ref. 1), EPA identified and assessed all known, intended, and
reasonably foreseen industrial, commercial, and consumer uses of PCE.
EPA determined that all industrial, commercial, and consumer uses of
PCE evaluated in the 2020 Risk Evaluation for PCE contribute to the
unreasonable risk of injury to health. As such, for purposes of this
risk management rule, ``consumer use'' refers to all known, intended,
or reasonably foreseen PCE consumer uses. Likewise, for the purpose of
this risk management rule, ``industrial and commercial use'' refers to
all known, intended, or reasonably foreseen PCE industrial and
commercial uses.
EPA further notes that this rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(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, when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic or device.
D. EPA's Proposed Rule Under TSCA Section 6(a) for PCE
1. Description of TSCA Section 6(a) Requirements
Under TSCA section 6(a), if the Administrator determines through a
TSCA section 6(b) risk evaluation that a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the Agency's risk evaluation, under the
conditions of use, EPA must by rule apply one or more of the section
6(a) requirements to the extent necessary so that the chemical
substance no longer presents such risk.
The TSCA section 6(a) requirements can include one or more of the
following actions alone in or combination:
Prohibit or otherwise restrict the manufacturing
(including import), processing, or distribution in commerce of the
substance or mixture, or limit the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce
(section 6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(section 6(a)(2)).
Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (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 (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 (section 6(a)(7)).
In the 2023 PCE proposed rule under TSCA section 6(a), EPA analyzed
how the TSCA section 6(a) requirements could be applied to address the
unreasonable risk from PCE so that it no longer presents such risk.
Unit II.D.1. of this final rule summarizes the TSCA section 6
considerations for issuing regulations under TSCA section 6(a). Unit V.
of the 2023 PCE proposed rule outlines how EPA applied these
considerations specifically to managing the unreasonable risk from PCE.
As required, EPA developed a proposed regulatory action and
alternative regulatory actions, which are described in Units IV.A. and
IV.B., respectively, of the 2023 PCE proposed rule. To identify and
select a regulatory action, EPA considered the two routes of exposure
driving the unreasonable risk, inhalation and dermal, and the exposed
populations. For occupational conditions of use, EPA considered how it
could directly regulate manufacturing (including import), processing,
distribution in commerce, industrial and commercial use, or disposal to
address the unreasonable risk. EPA also considered how it could
exercise its authority under TSCA to regulate the manufacturing
(including import), processing, and/or distribution in commerce of PCE
at different levels 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 the identified unreasonable risk, when
selecting among possible TSCA section 6(a) regulatory requirements for
the 2023 PCE proposed rule. EPA's considerations regarding TSCA section
6(c)(2)(A) for PCE are discussed in full in Unit VI. of the 2023 PCE
proposed rule, including the statement of effects with respect to these
considerations. After review of public comments received, EPA has
revised its statement of effects considerations in Unit V. of this
final rule.
Additionally, as described in more detail in the 2023 PCE proposed
rule, EPA considered the availability of alternatives when finalizing a
prohibition or a substantial restriction (TSCA section 6(c)(2)(C))
(Ref. 12), and in setting final compliance dates in accordance with the
requirements in TSCA section 6(d)(1).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and the National Institute for Occupational Safety and Health
(NIOSH) when developing its 2023 PCE proposed rule, with the goal of
identifying risk management control methods that would be permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated
community where appropriate and took into account the information
presented in the 2020 Risk Evaluation for PCE (Ref. 1), input from
stakeholders, insight received during consultations, and anticipated
compliance strategies from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and alternative actions described in Unit II.D.3.
Additional details related to how the requirements described in
[[Page 103567]]
this Unit II.D.1. were incorporated into development of the 2023 PCE
proposed rule and alternative actions are in Unit V. of the 2023 PCE
proposed rule.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and outreach as part of the development
of the 2023 PCE proposed rule. The Agency held a federalism
consultation from July 22, 2021, to October 22, 2021, as part of the
rulemaking process and pursuant to Executive Order 13132 (Ref. 13).
EPA also consulted with Tribal officials during the development of
the 2023 PCE proposed rule (Ref. 14). The Agency held a Tribal
consultation from May 17, 2021, to August 20, 2021, with meetings on
June 15 and July 8, 2021 (Ref. 14). EPA received no written comments as
part of this consultation.
EPA's Environmental Justice (EJ) consultation occurred from June 3,
2021, to 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 Executive Orders 12898 and 14008. EPA received five written
comments following the EJ meetings, in addition to oral comments
provided during the consultation (Refs. 15, 16, 17, 18, 19). The 2023
PCE proposed rule presents a brief summary of the comments in Unit
III.A.1. of the 2023 PCE proposed rule.
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 the rule's requirements.
EPA met with SERs before and during Panel proceedings, on September 26,
2022, and November 10, 2022. Panel recommendations were addressed in
Unit X.C. of the 2023 PCE proposed rule and in the Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 20); the Panel report is in the
docket (Ref. 21). EPA has also prepared a Final Regulatory Flexibility
Analysis (FRFA) (Ref. 22).
The Agency presents more information regarding the consultations in
Units X.C., X.E., X.F., and X.J. of the 2023 PCE proposed rule.
b. Other Stakeholder Consultations
For development of the 2023 PCE proposed rule, in addition to the
formal consultations described in Unit X. of the 2023 PCE proposed
rule, EPA held a webinar on January 14, 2021, providing an overview of
the TSCA risk management process and the risk evaluation findings for
PCE (Ref. 23). EPA also presented on the TSCA risk management process
and the findings in the 2020 Risk Evaluation for PCE (Ref. 24) at a
Small Business Administration (SBA) Office of Advocacy Environmental
Roundtable on January 15, 2021. Attendees of these meetings were given
an opportunity to voice their concerns regarding the risk evaluation
and risk management.
Furthermore, during development of the 2023 PCE proposed rule, EPA
engaged in discussions with representatives from different industries,
non-governmental organizations, organized labor, technical experts, and
users of PCE. A list of external meetings held during the development
of the 2023 PCE proposed rule is available in the docket (Ref. 25);
meeting materials and summaries are also available in the docket. A
summary of the topics discussed during these meetings is in Unit
III.A.2. of the 2023 PCE proposed rule.
c. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 26) 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.'' 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 (which includes unreasonable risk to any relevant potentially
exposed or susceptible subpopulations). Information on how the 2021
Policy was applied and on the health and risk assessments supporting
this action is available under Units II.C., II.D., and V.A., as well as
in Unit III.A.3. of the 2023 PCE proposed rule, the 2020 Risk
Evaluation for PCE (Ref. 1), and the Economic Analysis (Ref. 3).
3. Proposed Regulatory Action
EPA's 2023 PCE proposed rule under TSCA section 6(a) to address the
unreasonable risk presented by PCE under its conditions of use included
the following:
Prohibition of most industrial and commercial uses and the
manufacture (including import), processing, and distribution in
commerce, of PCE for those uses;
Prohibition of the manufacture (including import),
processing, and distribution in commerce of PCE for all consumer use;
Prohibition of the manufacture (including import),
processing, distribution in commerce, and commercial use of PCE in dry
cleaning and spot cleaning through a 10-year phaseout;
Requirements for 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 the 16 occupational conditions of use not prohibited;
Requirements for prescriptive workplace controls for
laboratory use;
Establishments of recordkeeping and downstream
notification requirements; and
A 10-year time-limited exemption under TSCA section 6(g)
for certain emergency uses of PCE in furtherance of NASA's mission, for
specific conditions of use which are critical or essential and for
which no technically and economically feasible safer alternative is
available.
EPA notes that all TSCA conditions of use of PCE were subject to
the 2023 PCE proposed rule and are subject to this final rule.
The 2023 PCE proposed rule included proposed timeframes for
implementation. The prohibitions EPA proposed for most conditions of
use would take effect in phases, beginning at the top of the supply
chain, and coming into full effect after 24 months, as described in
Units IV.A.1.a. and IV.A.1.b. of the 2023 PCE proposed rule. The
phaseout period for dry cleaning that EPA proposed would take full
effect after 10 years, as described in Unit IV.A.1.c. of the 2023 PCE
proposed rule. Likewise, for the WCPP, EPA proposed timeframes for
phases of compliance, beginning with monitoring at six months and full
implementation after 12 months, as described in Unit IV.A.2. of the
2023 PCE proposed rule. EPA also proposed a compliance timeframe of 12
months for prescriptive controls for laboratory use.
Under TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA is
mandated to consider one or more alternative regulatory actions. These
were included in the 2023 PCE proposed rule in Unit
[[Page 103568]]
IV.B. Similar to the proposed regulatory action, both the primary and
second alternative regulatory actions combined prohibitions,
requirements for a WCPP, and prescriptive controls to address the
unreasonable risk from PCE under its conditions of use.
The primary alternative regulatory action combined prohibitions, a
WCPP, and prescriptive controls to address the unreasonable risk from
PCE driven by its conditions of use. At the time of publication of the
2023 PCE proposed rule, uncertainties regarding 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, availability of alternatives, or whether the use
is ongoing or phased out for most of these conditions of use led EPA to
propose prohibition. At the time of proposal, EPA did not have
reasonably available information to confidently conclude that these
conditions of use could meet requirements of a WCPP. The alternative
regulatory action also considered and included WCPP for laboratory use
to seek input on requiring the non-prescriptive WCPP instead of the
prescriptive workplace controls included in the proposed regulatory
action. The primary alternative regulatory action also considered
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. Additionally, the primary alternative
regulatory action included requirements for a concentration limit for
PCE in industrial and commercial use in solvent-based adhesives and
sealants.
The primary alternative regulatory action also included longer
timeframes for prohibitions and implementation of WCPP and prescriptive
controls. Those timeframes were described in Unit IV.B. of the 2023 PCE
proposed rule.
The second alternative regulatory action combined prohibitions,
requirements for a WCPP, prescriptive controls, and two time-limited
exemptions to address the unreasonable risk from PCE driven by its
conditions of use. This second alternative regulatory action included
prohibitions on some conditions of use that would have requirements for
a WCPP under the proposed regulatory action.
The second alternative regulatory action also included shorter
compliance timeframes for prohibition and a WCPP. Additionally, this
second alternative regulatory action did not include staggered
prohibition compliance dates for manufacturers, processors, and
distributors. The secondary alternative regulatory action compliance
timeframes are described in Unit IV.B. of the 2023 PCE proposed rule.
For a comprehensive overview of the alternative regulatory actions,
refer to Unit IV.B. of the 2023 PCE proposed rule, with the rationale
for the alternative regulatory actions provided in Unit V.A.2. of the
2023 PCE proposed rule.
4. Public Comments Received
EPA requested comment on all aspects of the 2023 PCE proposed rule,
and during the public comment period, EPA held a webinar on July 19,
2023, providing an overview of the 2023 PCE proposed rule and TSCA
section 6; during the webinar, members of the public had the
opportunity to share their perspectives (Ref. 27). The comment period
closed on August 15, 2023. EPA received 749 public comments, with a
majority received from individuals participating in mass mailer
campaigns organized by non-governmental organizations. The public
comments also include approximately 89 unique comments from industry
stakeholders, trade associations, environmental groups, unions,
academic institutions, a State government agency, a Federal Government
agency, and members of the regulated community. A summary of the
comments as well as EPA's responses is in the docket for this
rulemaking (Ref. 8). Additionally, Unit III. contains summaries of
public comments that informed EPA's regulatory approach in this final
rule.
After the close of the public comment period for the 2023 PCE
proposed rule, EPA held meetings with stakeholders to receive
clarifying information on their comments, including affected industry
and interested groups, related to the use of PCE. Topics of these
meetings included exposure controls, process descriptions, monitoring
data, and specific conditions of use. EPA received data as part of and
following these stakeholder meetings and has made the information
available to the public in the rulemaking docket (Docket ID No. EPA-HQ-
OPPT-2020-0720) (Ref. 28).
After review of the public comments received on the 2023 PCE
proposed rule, EPA revised certain preliminary considerations that
impacted which conditions of use were proposed by EPA to be prohibited
or that could continue under the WCPP or prescriptive controls (Ref.
8). Similarly, based on public comments received, EPA modified for this
final rule several proposed compliance timeframes, with details in Unit
III.
III. Changes From the Proposed Rule Based on Public Comment
Unit III. summarizes the main changes from the 2023 PCE proposed
rule to this final rule, based on the consideration of the public
comments.
A. Changes to the Risk Management Approach for Certain Conditions of
Use
As described in Units III.A.1. and 2., when compared to the 2023
PCE proposed rule, EPA's final rule prohibits two additional conditions
of use (Unit III.A.1.), allows three additional conditions of use under
the WCPP (Units III.A.2.a. through c.), broadens the types of
prescriptive controls required for one condition of use (Unit
III.A.2.d.), and allows one additional condition of use to continue
under specific prescriptive controls or the WCPP (Unit III.A.2.e.).
The rationale for these changes is described in this unit. EPA
emphasizes that implementation of the WCPP or prescriptive controls can
fully address the unreasonable risk from PCE for the conditions of use
allowed to continue, and that these changes do not significantly impact
the production volume of PCE expected to remain in commerce when
compared to the proposed regulatory action. Taken together, the
conditions of use described in Unit III.A.1. and 2. account for less
than an estimated 5% of the total production volume of PCE.
1. Additional Conditions of Use Subject to Prohibition: Industrial and
Commercial Uses of PCE as a Solvent for In-Line Vapor Degreasing
EPA is finalizing a prohibition for the industrial and commercial
use of PCE as a solvent for in-line conveyorized vapor degreasing and
for in-line web cleaner vapor degreasing, which were considered for
prohibition in the second alternative regulatory action of the 2023 PCE
proposed rule. As described in section 6 of the Economic Analysis for
the 2023 PCE proposed rule (Ref. 29), EPA estimated that approximately
two conveyorized vapor degreasers and no web vapor degreasers use PCE.
One public commenter, a critical cleaning consultant, stated they no
longer encounter in-line conveyorized or in-line web vapor degreasers
using PCE (Ref. 30). Additionally, commenters identified alternative
types of degreaser technologies, such as open-top batch vapor
degreasers, closed-loop batch vapor degreasers, and airless batch vapor
degreasers, that clean effectively and for which monitoring data and
[[Page 103569]]
detailed process descriptions of PCE activities for these types of
degreasers confirm that compliance with an ECEL of 0.14 ppm as an 8-hr
TWA is possible (Refs. 30, 31). As described in Unit V.A.1. of the 2023
PCE proposed rule, prohibition is the preferred risk management option
for occupational conditions of use where reasonably available
information suggest minimal ongoing use or when feasible safer
alternatives are reasonably available. Based on information provided by
commenters and other information reasonably available to the Agency
indicating that the use of PCE in in-line conveyorized and in-line web
vapor degreasing is no longer ongoing, and availability of
technologically feasible alternative vapor degreasing technology, EPA
has determined that the unreasonable risk from PCE when used in both
types of in-line vapor degreasers is best addressed with a prohibition.
2. Additional Conditions of Use Subject to Restrictions: WCPP and
Prescriptive Controls
a. Processing PCE Into Formulation, Mixture, or Reaction Product in
Other Chemical Products and Preparations
EPA is finalizing a WCPP for processing PCE into formulation,
mixture, or reaction product in other chemical products and
preparations, as included in the primary alternative regulatory action
of EPA's proposal (88 FR 39652, June 16, 2023)(FRL-8329-02-OCSPP)).
While EPA proposed to prohibit processing PCE into formulation, mixture
or reaction product in other chemical products and preparations, this
was because EPA proposed to prohibit the downstream industrial,
commercial, and consumer uses associated with other chemical products
and preparations. EPA included this condition of use under the WCPP in
the primary alternative regulatory action.
EPA received several comments regarding processing PCE into
formulation, mixture, or reaction product. One commenter stated that
there appeared to be a disconnect between the proposed prohibitions on
processing PCE versus prohibitions on distribution and/or use of PCE
and requested that EPA clarify the prohibitions throughout all steps in
the supply chain for each particular condition of use (Ref. 32). For
example, the commenter stated that EPA proposed that PCE may be
processed into a formulation, mixture, or reaction product in paint and
coating mixtures but also proposed to prohibit the manufacturing,
processing, distribution in commerce, and use of PCE in solvent-based
paints and coatings. The commenter also stated that EPA proposed that
PCE could be used for industrial and commercial use in maskants for
chemical milling but did not explicitly permit the manufacturing or
processing of PCE for use in maskants. Another commenter expressed
opposition to EPA's proposed prohibition on processing of PCE for other
chemical products and preparations, and stated that the proposed
prohibition appeared to be based on an overly broad assumption that
exposures to PCE in this condition of use correspond to aerosol packing
(Ref. 33).
In Unit III.B.1.b.iv. of the 2023 PCE proposed rule, EPA described
how the condition of use of processing PCE into formulation, mixture,
or reaction products in paint and coating products refers to when PCE
is added to a paint or coating product for further distribution,
including when PCE is incorporated into coating products such as
maskant (88 FR 39652, June 16, 2023)(FRL-8329-02-OCSPP)). However, to
avoid confusion regarding which processing into formulation, mixture,
or reaction product condition of use of PCE is associated with each
downstream industrial and commercial condition of use of PCE, and, in
particular, confusion regarding which products may fall under the
category of ``other chemical products and preparations,'' EPA is
finalizing WCPP for all PCE processing into formulation, mixture, or
reaction products, including in other chemical products and
preparations, to make clear that all processing of PCE into
formulation, mixture, or reaction product conditions of use, including
in cleaning and degreasing products, in adhesive and sealant products,
and in paint and coating products that are not prohibited by virtue of
the downstream use being prohibited, are subject to the WCPP. As in the
2023 PCE proposed rule, all manufacturing, processing, and distribution
in commerce of PCE for any downstream industrial, commercial, or
consumer condition of use that is prohibited under the final rule would
also be prohibited. In response to a comment requesting clarity
regarding prohibitions throughout all steps of the value chain for each
condition of use, EPA clarifies that the final rule includes
prohibitions (staggered by lifecycle stage) for the manufacture,
processing, distribution in commerce, and for all consumer, industrial
and commercial use of PCE and PCE-containing products, except for those
industrial and commercial uses which will continue under the WCPP or
prescriptive controls, or are otherwise not prohibited. Therefore, in
this final rule, WCPP applies to processing PCE for uses that are not
prohibited.
b. Industrial and Commercial Use of PCE as a Processing Aid
EPA is finalizing a WCPP for industrial and commercial use of PCE
as a processing aid in pesticide, fertilizer, and other agricultural
manufacturing, as included in the primary alternative regulatory action
of the 2023 PCE proposal rule. While EPA proposed to prohibit the
industrial and commercial use of PCE as a processing aid in pesticide,
fertilizer, and other agricultural manufacturing, this was due to
insufficient information at the time of proposal to determine that
compliance with the WCPP would be possible. For example, at the time of
proposal, EPA was not aware of any monitoring data or detailed
description of PCE activities for this use to confirm that compliance
with an ECEL of 0.14 ppm as an 8-hr TWA would be possible. EPA
requested comment on the ability of facilities in this sector to
successfully implement the WCPP for this particular use because of the
industrial nature of the use.
EPA received a few comments regarding the industrial and commercial
use as a processing aid in pesticide, fertilizer, and other
agricultural manufacturing. Two commenters disagreed with EPA's
proposal to prohibit PCE use as a processing aid in the manufacture of
agricultural chemicals and stated that it is unclear what information
EPA relied on to conclude that this use could not meet the WCPP
requirements (Refs. 33, 34). One commenter stated that this use of PCE
is critical to the manufacture of certain agricultural products and
described how they limit PCE exposure and manage production risks
through strong product stewardship and industrial hygiene practices.
Following a meeting to receive clarifying information on their comment,
one commenter submitted information on worker activities and safety
measures in place that provide worker protection for this use (Ref.
35). As described in the submitted information, activities associated
with potential exposure to PCE include transfer, sample, and
maintenance, where control measures such as purging lines/vessels prior
to opening, closed sampling box, and PPE reduce exposures. Based on the
information received, EPA believes such control measures that indicate
the ability to comply with the WCPP requirements may be implementable
for all those using PCE as a processing aid
[[Page 103570]]
in pesticide, fertilizer, and other agricultural chemical
manufacturing.
Additionally, information submitted to EPA indicates that PCE may
be used as a processing aid in industrial sectors other than
petrochemical manufacturing and pesticide, fertilizer, and other
agricultural chemical manufacturing (Refs. 33, 36). The 2020 Risk
Evaluation assessed occupational exposures for ``processing aids,
specific to petroleum production--catalyst regeneration in
petrochemical manufacturing'' and ``processing aids, not otherwise
listed--pesticide, fertilizer and other agricultural chemical
manufacturing'' under the industrial processing aid Occupational
Exposure Scenario (Ref. 1). While other specific processing aid uses of
PCE were not identified in the 2020 Risk Evaluation, EPA expects the
exposure assessment, including the worker activities, to be consistent
across all processing aid type uses. For example, as assessed in the
risk evaluation, worker activities that may result in exposure for use
as a processing aid include unloading PCE into process equipment and
maintenance. Similar to control measures that reduce the potential for
exposure and indicate the ability to comply with the WCPP for use as a
processing aid in the pesticide, fertilizer, and other agricultural
chemical manufacturing sector, EPA has determined that control measures
such as use occuring in a highly specialized closed system with minimal
exposure to PCE during infrequent worker activity limit the potential
for exposure and indicate the ability to comply with the WCPP for use
as a processing aid in other industrial sectors. Therefore, EPA
believes the WCPP requirements are practicable and implementable for
all processing aid uses which occur at sophisticated industrial sites.
EPA's determination is based on reasonably available information
included in submissions to EPA related to process descriptions, worker
activities, and exposure mitigation practices for use of PCE as an
industrial processing aid in sectors other than petrochemical
manufacturing and pesticide, fertilizer, and agricultural chemical
manufacturing (Refs. 1, 36).
The information submitted to EPA as part of the comment period
regarding the industrial and commercial use of PCE as a processing aid
in sectors other than petrochemical manufacturing (including industrial
and commercial use as a processing aid in pesticide, fertilizer and
agricultural chemical manufacturing) and supported by subsequent
discussions, demonstrated the users' ability to comply with the WCPP.
For this reason, EPA has determined that the unreasonable risk from PCE
when used as a processing aid, even in sectors other than petrochemical
manufacturing and pesticide, fertilizer, and agricultural chemical
manufacturing, could be addressed with a WCPP. Therefore, in this final
rule, EPA is finalizing a WCPP for all industrial and commercial use of
PCE as a processing aid in sectors other than petrochemical
manufacturing and a WCPP for industrial and commercial use of PCE as a
processing aid in catalyst regeneration in petrochemical manufacturing.
c. Industrial and Commercial Use of PCE as Solvent for Cold Cleaning of
Tanker Vessels
EPA is finalizing a WCPP for industrial and commercial use of PCE
as solvent for cold cleaning of tanker vessels, which is a sub-use of
the industrial and commercial use of PCE as solvent for cold cleaning,
which EPA proposed to prohibit in the proposal (88 FR 39652, June 16,
2023) (FRL-8329-02-OCSPP)). While EPA proposed to prohibit industrial
and commercial use of PCE as solvent for cold cleaning, this was due to
insufficient information at the time of proposal to determine that
compliance with the WCPP would be possible and EPA believed
alternatives were reasonably available. EPA requested comment on
whether to consider a regulatory alternative that would subject more
conditions of use of PCE to a WCPP, instead of a prohibition, than
those contemplated in the primary alternative regulatory action. EPA
also requested 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 received one comment regarding the industrial and commercial
use of PCE in cold cleaning of tanker vessels. The commenter requested
that EPA not prohibit this use because entities utilize PCE and other
solvents, such as methylene chloride, ortho-dichlorobenzene,
monochlorobenzene, and toluene, to clean tanks safely and effectively,
when water and detergents are not compatible with the cargo material
(Ref. 37). The commenter suggested that EPA establish the WCPP to
maintain this use. Following a September 26, 2023, meeting with an
industry user to receive clarifying information on their comment, the
commenter submitted information on worker activities and safety
measures in place that provide worker protection for this use (Ref.
38). As described in the submitted information, tank cleaning with a
solvent is typically infrequent (about every two years) and worker
exposure occurs during sampling and connecting or disconnecting of
hoses to or from the ship manifold or waste truck, activities during
which control measures are in place. Based on the information submitted
regarding this condition of use, and supported by subsequent
discussions, EPA believes such controls and safety measures may be
implementable industry wide.
EPA received two comments regarding industrial and commercial use
of PCE in cold cleaning generally. One commenter stated that the
empirical and modeled exposure data for cold cleaning in the risk
evaluation are very similar to that for degreasing, but EPA proposed to
allow continued use of PCE under the WCPP in vapor degreasing and not
cold cleaning (Ref. 33). Another commenter associated with the
aerospace and defense sector urged EPA to permit ongoing use under the
WCPP for PCE as a cold, immersion cleaner (Ref. 32). However, for all
cold cleaning other than cold cleaning of tanker vessels, EPA does not
have any reasonably available information, including monitoring or
detailed process description, that supports the ability to comply with
a WCPP such that the risks are no longer unreasonable. EPA does not
have any reasonably available information that indicates the exposure
frequency, worker activities, and safety measures associated with cold
cleaning of tanker vessels, as described by the commenter, are
applicable to other cold cleaning operations, which may vary in
equipment design or worker activities (Ref. 37, 38).
The information submitted to EPA during the comment period
regarding the industrial and commercial use of PCE as a solvent for
cold cleaning of tanker vessels, supported by subsequent discussions,
demonstrated the users' ability to comply with the WCPP. For this
reason, EPA has determined that the unreasonable risk from PCE when
used in cold cleaning of tanker vessels could be addressed with a WCPP.
EPA is finalizing a prohibition for all other cold cleaning
applications of PCE.
d. Industrial and Commercial Use of PCE as a Laboratory Chemical
In general, EPA is finalizing the prescriptive control requirements
for the industrial and commercial use of PCE as a laboratory chemical
as proposed, with some modifications, based on consideration of public
comments. As described in the 2023 PCE proposed rule, to address the
unreasonable risk of injury to health resulting from dermal
[[Page 103571]]
exposures to PCE for the industrial and commercial use as a laboratory
chemical, EPA proposed to require dermal PPE in combination with
comprehensive training for tasks related to the use of PCE in a
laboratory setting for each potentially exposed person in direct dermal
contact with PCE. EPA also proposed to require the use of fume hoods 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). EPA requested comment relative to the
ability of owners and operators to implement laboratory chemical fume
hood and dermal PPE-related requirements within 12 months of
publication of the final rule. Under the primary alternative regulatory
action, EPA included the WCPP for laboratory use of PCE and solicited
comment on non-prescriptive requirements to meet an ECEL and Direct
Dermal Contact Control (DDCC) as compared to the prescriptive workplace
controls of using a fume hood and dermal PPE.
EPA received several comments regarding the industrial and
commercial use of PCE as a laboratory chemical. Several commenters
stated that the proposed regulation would result in confusion and
duplication with the OSHA standard for occupational exposure to
hazardous chemicals in laboratories under 29 CFR 1910.1450 that is
already in effect (Refs. 39, 40, 41). The commenters urged EPA to more
closely align its requirements for laboratory use of PCE with OSHA's
laboratory standard to reduce the compliance burden. Some commenters
expressed support for the use of fume hoods and other engineering
controls over the WCPP and suggested that EPA include flexibility for
engineering controls beyond a fume hood for consistency with the OSHA
laboratory standard (Refs. 40, 42). The commenters stated that while
fume hoods are considered best practice and are commonly used to reduce
exposure in laboratories, some experiment designs utilizing PCE may not
be able to be accommodated within a fume hood. Commenters described
other alternative controls that can be designed and implemented to
reduce exposure, such as glove boxes, exhausted enclosures, air-free
solvent purification systems, and fume extractors. One commenter
described other laboratory standards, including the American National
Standards Institute (ANSI)/American Society of Safety Professionals
(ASSP) Z9.5 Laboratory Ventilation standard and the ANSI/American
Society of Heating, Refrigerating and Air-Conditioning Engineers
(ASHRAE) 62.1 Ventilation and Acceptable Indoor Air Quality standard,
that laboratories adhere to in addition to OSHA's laboratory standard
that they state meet or exceed the worker protections under EPA's
proposed WCPP and prescriptive controls (Refs. 41, 43, 44).
Based on information provided by commenters related to exposure
mitigation controls to comply with the OSHA laboratory standard and
best management practices available to laboratories, EPA has determined
that requiring laboratory ventilation devices such as fume hoods or
glove boxes would better align with the OSHA laboratory standard and
existing good laboratory practices. As described in Unit V.A.1. of the
2023 PCE proposed rule, EPA proposed to require fume hoods in
laboratory settings to codify assumptions made in the 2020 Risk
Evaluation for PCE, where EPA's risk estimates and determination that
inhalation exposures from the industrial and commercial use of PCE as a
laboratory chemical did not contribute to the unreasonable risk were
predicated on its findings that expected safety practices of using PCE
in small amounts under a fume hood reduce the potential for inhalation
exposures. For the industrial and commercial use of PCE as a laboratory
chemical, EPA concurs with the commenters that indicated EPA's
requirements should align more closely with the OSHA laboratory
standard wherever possible to prevent confusion. The requirement in
this final rule that laboratory ventilation devices, such as fume hoods
or glove boxes, 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 PCE is used
in a laboratory setting aligns with existing requirements from 29 CFR
1910.1450(e)(3)(iii).
As detailed in Unit IV.C. of this final rule, EPA is finalizing as
proposed the requirements for dermal PPE in combination with
comprehensive training for tasks related to the use of PCE in a
laboratory setting. EPA believes these requirements align with OSHA's
laboratory standard and OSHA's General Requirements for Personal
Protective Equipment at 29 CFR 1910.132 to the extent possible while
still addressing the unreasonable risk of injury to health resulting
from dermal exposures to PCE identified for the industrial and
commercial use as a laboratory chemical.
e. Industrial and Commercial Use of PCE as Energized Electrical Cleaner
EPA is finalizing requirements to comply with either specific
prescriptive controls or the WCPP for the industrial and commercial use
of PCE as energized electrical cleaner, which is a sub-use of the
industrial and commercial use of PCE as solvent for aerosol spray
degreaser/cleaner, as described in Unit III.B.1.c.vi. of the 2023 PCE
proposed rule. In the proposal, EPA proposed to prohibit the industrial
and commercial use of PCE as solvent for aerosol spray degreaser/
cleaner because the Agency was not able to identify reasonably
available information such as monitoring data or detailed activity
descriptions to indicate with certainty that relevant regulated
entities could mitigate the identified unreasonable risk through a
WCPP. EPA considered requiring a WCPP for this condition of use under
the primary alternative regulatory action because of uncertainties
regarding the availability of alternatives for all aerosol spray
degreasing/cleaning applications, including for energized electrical
cleaning. EPA requested comment on the ways PCE may be used, including
the likelihood of successful compliance with the WCPP for this
condition of use. EPA also requested 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. Additionally, EPA requested
comment on whether to include a self-certification requirement for
purchasing PCE or PCE-containing products.
EPA received several comments expressing concern over the proposed
prohibition on energized electrical cleaning (Refs. 45, 46, 33, 47, 48,
49). Several commenters stated that safer alternatives are not
available because alternative products not containing PCE likely
present a flammability safety issue (Refs. 45, 48, 47, 50). A commenter
also stated that some cleaning in the electrical utility industry is
conducted underground in confined spaces where respiratory protection
is used and a non-flammable product, such as those containing PCE, is
needed to control a potential fire hazard (Ref. 45). In addition to
describing the need for PCE in energized electrical cleaning,
commenters described the work practices and context that support the
potential for exposure reduction to PCE through workplace controls,
rather than prohibition. As an example, one commenter described work
practices
[[Page 103572]]
and controls for energized electrical cleaning, stating that facilities
that require cleaning of energized equipment rely on skilled
technicians or other professional users who typically have education
and training that may include two years at lineman school, time as an
apprentice, licensing or certifications, and continuing education (Ref.
45).
Additionally, the commenter stated that OSHA General Industry and
Construction standards include requirements specific to electrical work
under 29 CFR part 1926, subparts E, K, and V. Commenters also described
State-level regulations that exclude energized electrical cleaners from
prohibitions on the manufacture and sale of PCE-containing general
purpose degreasing products, electrical cleaners, and electronic
cleaners (Refs. 45, 49). Another commenter stated that EPA should not
prohibit energized electrical cleaning because petroleum refineries
safely use energized electrical cleaners on a regular basis (Ref. 48).
While many commenters advocated for continued use of PCE for this
condition of use, they differed in whether the WCPP or other workplace
controls would be most suitable. Some commenters stated that the WCPP
would be impractical for energized electrical cleaning because trained
technicians often travel to different facilities to conduct work,
including facilities that may not otherwise use PCE, and suggested that
instead of a WCPP, a training and certification program would be
sufficient to address the unreasonable risk (Refs. 45). Other
commenters suggested PCE use for cleaning of energized electrical
equipment should be exempt from the rule under a TSCA section 6(g)
exemption (Refs. 45, 46, 33, 47).
Based on the information submitted to EPA as part of the comment
period regarding this condition of use, supported by subsequent
discussions, and in consideration of existing best practices and
regulations for work in electrical spaces as well as the lack of
reasonably available technically and economically feasible alternatives
to PCE that also do not present a potential flammability concern for
energized electrical cleaning, EPA has determined that the unreasonable
risk from PCE when used as energized electrical cleaner could be
addressed with a combination of labeling, self-certification, and
either the WCPP or specific prescriptive controls, including dermal PPE
and respiratory protection. EPA notes the importance of existing OSHA
regulations designed to protect workers exposed to dangers such as
electric shock, electrocution, fires, and explosions. Specifically, in
addition to the requirements for electrical work under OSHA General
Industry and Construction standards at 29 CFR part 1926, subparts E, K,
and V that one commenter mentioned in their public comment, OSHA
regulates electrical work under Occupational Safety and Health
standards at 29 CFR part 1910. For example, OSHA requires safety-
related work practices on electrical equipment under the Electrical
Standard at 29 CFR part 1910, subpart S (29 CFR 1910.301 to 1910.399),
which was significantly updated in 2007. OSHA also sets forth
requirements for the operation and maintenance of electrical power
generation, control, transformation, transmission, and distribution
lines and equipment under the Electric Power Generation, Transmission,
and Distribution Standard at 29 CFR part 1910, subpart R (29 CFR
1910.269), last amended in 2015. Additionally, OSHA regulates
electrical protective equipment under the Electrical Protective
Equipment Standard at 29 CFR part 1910, subpart I (29 CFR 1910.137),
which was significantly updated in 2014. Other standards and best
practices apply to electrical safety in the workplace, for example the
National Fire Protection Association 70E Standard for Electrical Safety
in the Workplace (Ref. 51).
Under the Electrical Standard at 29 CFR 1910.333 and the Electric
Power Generation, Transmission, and Distribution Standard at 29 CFR
1910.269, OSHA requires employers to establish minimum approach
distances from exposed energized parts, depending on the voltage, that
persons must maintain unless they are a qualified employee that meets
certain requirements under 29 CFR 1910.269(l)(3)(iii)(A) through (C) or
29 CFR 1910.333(c)(3)(ii)(A) through (C). In instances where persons
need to clean or degrease energized equipment in an area that is not
considered a confined space, as defined in 29 CFR 1910.146(b), or an
enclosed space (such as a manhole or vault) as described in 29 CFR
1910.269(e), for example housekeeping overhead lines, but are not
permitted to approach or take conductive objects closer to the exposed
energized part than the employer's established minimum approach
distance, persons may be able to use tools, such as a hotstick with an
aerosol spray can holder adapter or other live-line tools to clean the
energized equipment (Ref. 52). In such instances where persons are
maintaining the established minimum approach distance while conducting
energized electrical cleaning in an area that is not confined or
enclosed, EPA believes the potential for inhalation exposures is
minimal.
As noted earlier, EPA has determined that the unreasonable risk
from PCE when used as energized electrical cleaner could be addressed
with a combination of labeling, self-certification, and either (i)
specific prescriptive controls, including dermal PPE and respiratory
protection, or (ii) the WCPP. EPA's finalized requirements for
industrial and commercial use of PCE as energized electrical cleaner
are described in Unit IV.C.2. Other industrial and commercial use as a
solvent for aerosol spray degreasers/cleaners is prohibited in the
final rule, consistent with the proposal for that condition of use.
EPA's workplace requirements to address the unreasonable risk for PCE
as an energized electrical cleaner are consistent to the extent
possible with existing regulations and best practices for work in
electrical spaces such as OSHA's Electrical Standard at 29 CFR part
1910, subpart S and the Electric Power Generation, Transmission, and
Distribution Standard at 29 CFR part 1910, subpart R.
In this final rule, EPA is also adding a definition of ``energized
electrical cleaner'' to 40 CFR 751.603, consistent with the definition
promulgated in States such as California (Title 17, California Code of
Regulations, Article 2, section 94508), New York (6 CRR-NY III A 235),
Maine (06 ME Code Rules Sec. 096-152), Rhode Island (250-RICR-120-05-
31), Connecticut (section 22a-174-40), Delaware (7 Del. Admin. Code
Sec. 1141-1.0), Washington, DC (20 DCMR, Chapter 7, section 718),
Maryland (COMAR 26.11.32), New Jersey (New Jersey Administrative Code
5:23-6.1), Indiana (Standards for Consumer and Commercial Products
(CCP)--VOC Rule 326 IAC 8-15), Illinois (Administrative Cod Title 35,
Sec. 223.265), and Massachusetts (310 CMR 7.25).
B. Changes to Timeframes
1. Changes to the WCPP Timeframe
For the conditions of use for which EPA proposed the WCPP, EPA
proposed several compliance timeframes, including the following
requirements:
Initial exposure monitoring must be conducted within six
months of publication of the final rule or within 30 days of
introduction of PCE into the workplace if PCE use commences at least
six months after the date of publication;
Each owner or operator ensure that exposure to PCE does
not exceed the ECEL as an 8-hour TWA for all
[[Page 103573]]
potentially exposed persons within nine months of publication of the
final rule; and
Owners and operators implement an exposure control plan
within 12 months of publication of the final rule.
In the primary alternative regulatory action described in the 2023
PCE proposed rule, EPA described slightly longer timeframes that
included the following:
Initial exposure monitoring be conducted within 12 months
of publication of the final rule;
Each owner or operator ensures that the exposure to PCE
does not exceed the ECEL as an 8-hour TWA for all potentially exposed
persons within 15 months of publication of the final rule; and
Owners and operators implement an exposure control plan
within 18 months of publication of the final rule.
EPA requested comment regarding the ability of owners or operators
to comply with the various provisions of the WCPP, including initial
exposure monitoring, within the compliance timelines included in the
proposal, and anticipated timelines for any procedural adjustments
needed to comply with the establishment of a respiratory protection
program and development of an exposure control plan. EPA further
requested comment on any advantages or drawbacks associated with the
longer timeframes outlined in the primary alternative regulatory
action, and noted that the Agency may finalize significantly shorter or
longer compliance timeframes based on consideration of public comments.
EPA also requested comment regarding issues around the viability of
current analytical methods and detection limits for occupational PCE
sampling and/or monitoring methods.
Public comments highlighted challenges with the proposed timeframes
and suggested longer timeframes for initial exposure monitoring. For
example, some commenters stated that the proposed 6-month timeframe
within which to conduct initial exposure monitoring may not be possible
because PCE use may be infrequent and occur only periodically or
annually, such as in maintenance exercises or in batch manufacturing
operations (Refs. 53, 54, 32). One commenter expressed concern that
requirements to comply with a new exposure limit would stress
industrial hygiene consultants and laboratories that analyze the
samples, and urged EPA to ensure that there would be adequate time for
consultant firms and laboratories to establish sufficient capacity
(Ref. 55). Some commenters described how entities need more time than
what was proposed to assess exposures to various products and processes
and noted that the complexity of the WCPP provisions would require
taking multiple measurements for the presence of PCE in various
operations across multiple facilities, which will be challenging to
layer on top of the employer's OSHA compliance practices (Refs. 32, 47,
54). Other commenters stated the proposed 6-month timeframe for initial
monitoring would be untenable and suggested that the deadline be
extended to 12 months (Refs. 31, 33, 56, 49). Two commenters reasoned
that at least 12 months would be necessary to revalidate methods and
determine whether revision to corporate exposure assessment strategy
would be necessary to address the new ECEL (Refs. 33, 49). Commenters
stated that a corporate exposure assessment strategy or similar
mechanism would necessitate the procurement of professional services,
adding logistical demand for these specialized services. The commenters
also noted that monitoring at the proposed ECEL and action level would
likely require laboratory analysis (rather than direct measurement)
that will delay the availability of results and make meeting a 6-month
timeframe challenging.
In consideration of public comments and the challenges of
initiating the WCPP, even for facilities with industrial hygiene
programs in place, and the difference in the occupational exposure
limits between the OSHA permissible exposure limit (PEL) and the EPA
ECEL and the challenges associated with monitoring to new, lower EPA
exposure thresholds that may spur an increase in the need for
monitoring or other exposure control assessment infrastructure, EPA has
determined that a longer compliance deadline of 360 days, as provided
in the primary alternative regulatory action described in the proposal,
is as soon as practicable to conduct initial monitoring for PCE, which
likely would require regulated entities to contract new services or
realign current industrial hygiene professionals towards WCPP
compliance. Adopting this timeframe from the primary alternative
approach (providing 360 days for initial monitoring) is intended to:
(1) prevent professional safety service sectors from being overwhelmed
by new EPA requirements; (2) provide time to procure the necessary
services while ensuring the preservation of safety quality, standards,
and practices; and (3) provide sufficient time for a comprehensive
exposure evaluation, increasing the likelihood of successful
implementation of the WCPP. Following initial monitoring, EPA is
finalizing the requirement that each owner or operator supply a
respirator to each person who enters a regulated area within three
months after the receipt of any exposure monitoring that indicates
exposures exceeding the ECEL. Therefore, the requirements for each
owner or operator to ensure that exposures to PCE do not exceed the
ECEL as an 8-hour TWA for all potentially exposed persons, including by
providing respiratory protection, take effect 450 days after
publication of the final rule. Given the full WCPP requirements
(including the exposure control plan) are required after owners or
operators are required to ensure that no person is exposed to an
airborne concentration that exceeds the TWA ECEL, EPA acknowledges that
compliance with the ECEL may include temporary PPE use (e.g.,
respiratory protection) until comprehensive engineering and
administrative controls are fully implemented. As described in the 2023
PCE proposed rule, EPA believes that three months after receipt of
exposure monitoring results is as soon as practicable, while also
providing a reasonable transition period for entities to evaluate
exposure monitoring results, acquire the correct respiratory
protection, and establish the PPE program, including training, fit-
testing, and medical evaluation. Additionally, for clarity in
regulatory requirements and reduced burden in implementation, EPA is
finalizing a compliance date for preventing direct dermal contact,
including by use of dermal PPE, that is 450 days after publication of
the final rule, so that this compliance timeframe is consistent with
timeframe to ensure inhalation exposures do not exceed the ECEL. EPA
believes that 450 days is as soon as practicable and provides a
reasonable transition period for regulated entities to evaluate
potential for direct dermal contact with PCE, establish a PPE program,
acquire the appropriate dermal PPE, and conduct the required training.
EPA also received public comment regarding the compliance timeframe
for full implementation of the WCPP, including detailing the evaluation
steps that would be required to assess a facility and develop,
document, and implement an exposure control plan. To allow time for
orderly transitions and training to comply with an ECEL (0.14 ppm (8-hr
TWA)) that is significantly lower than the OSHA PEL of 100 ppm (8-hr
TWA) and the American Conference of Governmental Industrial Hygienists
(ACGIH) threshold limit
[[Page 103574]]
value (TLV) of 25 ppm (8-hr TWA) for PCE, some commenters suggested
that EPA adopt a graduated implementation approach for ECEL
implementation by first requiring entities that already meet the OSHA
PEL to comply with the ACGIH TLV within two years from the effective
date of the final rule and then permitting those facilities meeting the
ACGIH standard two years to transition to the ECEL (Refs. 57, 54). Two
commenters expressed concern that the proposed timeframes would be
insufficient for owners or operators to document their efforts to
implement the hierarchy of controls as required under the WCPP, and
recommended that the time required to develop the exposure control plan
be extended to two years from completion of initial monitoring, for a
total of 24 to 36 months from the effective date of the final rule, to
provide adequate time for entities to evaluate and implement
appropriate compliance approaches that are the least burdensome and
most effective for workers (Refs. 49, 33).
Based on comments, outreach, reasonably available information,
existing OSHA standards, and industry best practices, EPA maintains
that the majority of the exposure reduction and worker safety
infrastructure needed for compliance is currently in place, but
recognizes the fundamental challenge of building a new exposure control
strategy around the new, lower EPA exposure limit. Additionally, based
on consideration of public comment and given that OSHA has not
promulgated a detailed standard specific to PCE, EPA has determined
that a longer compliance timeframe of 900 days for development and
implementation of an exposure control plan is as soon as practicable to
ensure that the regulated community has adequate time to evaluate
monitoring data, assess and develop an exposure strategy, procure
appropriate control technology and PPE, and implement the required
chemical safety program for PCE.
Therefore, EPA is finalizing the compliance timeframes for the WCPP
provisions as follows: (1) The requirements for each owner or operator
to conduct initial baseline monitoring must be met within 360 days of
the publication date for this final rule or within 30 days of
introduction of PCE into the workplace, whichever is later; (2) The
requirements for each owner or operator to ensure that exposure to PCE
does not exceed the ECEL as an 8-hour TWA for all potentially exposed
persons, including by providing respiratory protection to all
potentially exposed persons in the regulated area must be met within
450 days of the publication date for this final rule or within three
months after receipt of the results of any exposure monitoring that
indicates an exceedance of the ECEL; (3) The requirements that each
owner or operator ensure all persons are separated, distanced,
physically removed, or isolated from direct dermal contact with PCE,
including by providing dermal PPE, must be met within 450 days of the
publication date of this final rule; and (4) The requirements for
development and implementation of an exposure control plan must be met
within 900 days of the publication date of this final rule. EPA is also
finalizing as proposed, with a slight modification, the requirement
that owners and operators institute a training and information program
for potentially exposed persons and assure their participation in the
training and information program, and that this requirement be met
within 450 days of the publication date of this final rule (see Unit
IV.B.7.a.).
However, EPA understands that understands that certain departments
and agencies of the Federal government, as well as Federal contractors
acting for or on behalf of the Federal government, need additional time
to comply with these timeframes. For example, complying with these
timeframes could impact the ability of the Department of Defense to
continue to engage in vapor degreasing. While, for example, 29 CFR part
1960 sets forth procedures and guidelines for ensuring that Federal
workers are protected in comparable ways to their non-Federal
counterparts, EPA believes that compliance with this final rule will
require increased and different preparations on the part of Federal
agencies. For example, Federal agencies must follow procurement
requirements which will likely result in increased compliance
timelines. In addition, these requirements will require support in the
Federal budget, which, for some agencies, is a multi-year process.
Therefore, EPA is providing additional time for agencies of the Federal
government and their contractors, when acting for or on behalf of the
Federal government, to comply with the WCPP, including 915 days for
initial monitoring, 1,005 days to ensure that no person is exposed to
an airborne concentration of PCE that exceeds the ECEL, and 1,095 days
to implement an exposure control plan.
2. Changes to Prohibition Timeframes
For most occupational conditions of use that EPA proposed to
prohibit, EPA proposed that prohibitions would become effective in a
staggered schedule for each stage of the supply chain and would come
into effect after the publication of this final rule: In 12 months for
manufacturers, 15 months for processors, 18 months for distributors to
retailers, 21 months for all other distributors (including retailers),
and 24 months for industrial and commercial users. For consumer uses,
EPA proposed that the prohibitions of manufacturing, processing, and
distribution in commerce of PCE for consumer use would take effect
after the publication of this final rule: In 12 months for
manufacturers, 15 months for processors, 18 months for distributing to
retailers, and 21 months for all other distributors and retailers.
EPA's primary alternative regulatory action, discussed in the 2023 PCE
proposed rule, included slightly longer timeframes, which begin after
the publication of this final rule: In 18 months for manufacturers, 21
months for processors, 24 months for distributing to retailers, 27
months for all other distributors (including retailers), and 30 months
for industrial and commercial uses. EPA requested comment regarding the
proposed and alternative compliance dates for prohibitions and whether
additional time is needed.
Several commenters raised concerns about the timeframe for
complying with prohibitions from the proposed regulatory action,
stating that EPA should consider longer timeframes for prohibition to
avoid disruptions to the supply chain for continuing uses, help
minimize disposal of products left on retail shelves, and provide
sufficient time to identify, research, test, qualify, and implement
cost-effective alternative substances or processes (Refs. 32, 50, 33).
One commenter expressed concern that the proposed compliance timeframes
would cause certain products containing PCE to leave the market,
potentially cutting off PCE supply for continuing critical uses and
creating a risk of obsolescence for essential equipment that is reliant
on PCE.
Some commenters expressed that there may be circumstances in which
a chemical alternative is not an exact, drop-in replacement for certain
conditions of use, or in which new, additional, or modifications to
existing engineering equipment could be necessary (Refs. 33, 50, 45).
These commenters further expressed concerns regarding coordination with
suppliers or customers across the supply chain (including with
certifying entities in circumstances where a formulation change may
require recertifying a product to meet performance standards, for
example) that may require a
[[Page 103575]]
transitioning process. Due to these and other concerns, some commenters
supported longer timeframes for prohibition than what was proposed,
which would provide additional time that commenters described as
necessary for seeking alternatives, successfully implementing their
use, and mitigating supply chain impacts (Refs. 33, 50, 45). One
commenter stated that the proposed 24-month prohibition is
significantly shorter than for other EPA programs, such as EPA's
National Emission Standards for Hazardous Air Pollutants (NESHAP) which
typically provide 36 months for compliance, and suggested that EPA
extend the deadlines to 12 months for manufacturing, 21 months for
processing, 24 months for distribution to retailers, and 30 months for
retail distribution (Ref. 50). Other commenters recommended that EPA
double the proposed prohibition timeframes for manufacturers and
processors, suggested longer timeframes, and suggested that EPA extend
the sell-through period of products already in commerce by six months
(Refs. 45, 46, 33).
After reviewing all of the comments, in this final rule EPA is
modifying the proposed prohibition compliance timeframes for most uses
to lengthen them to the prohibition compliance timeframes included in
the primary alternative regulatory action, which will allow for
successful implementation of the prohibitions in a manner that is as
soon as practicable while providing for a reasonable transition period.
This extension will also provide additional time for regulated entities
to consult with their upstream suppliers and downstream customers and
to make necessary adjustments, thereby mitigating immediate concerns
for operational continuity for conditions of use identified in Units
IV.B. and C. The timeframes for prohibition EPA is finalizing are
described in detail in Unit IV.D.
EPA is finalizing as proposed the prohibition on the manufacturing,
processing, distribution in commerce, and industrial and commercial use
of PCE for dry cleaning and spot cleaning through a 10-year phaseout,
as outlined in Unit IV.D.3.
C. Changes to WCPP Requirements
1. Exposure Monitoring Requirements
As part of the WCPP, EPA proposed to require owners or operators to
meet certain documentation requirements for each monitoring event of
PCE, including compliance with the Good Laboratory Practice (GLP)
Standards in accordance with 40 CFR part 792.
Numerous commenters expressed concern regarding the requirement
that the WCPP include compliance with the GLP Standards at 40 CFR part
792 (Refs. 46, 54, 53, 56, 48, 55, 49). Commenters stated that it is
atypical, for industrial hygiene purposes, to use this standard for air
sampling of PCE (Refs. 33, 55, 49). According to the commenters, it is
common practice within the industrial hygiene community to have
analyses performed by American Industrial Hygiene Association (AIHA)
accredited laboratories (Ref. 49). Some commenters recommended that
provisions of monitoring results and recordkeeping in the final rule be
allowed from any accredited laboratory, without regard to a specific
type, or allowing any number of approved monitoring methods, especially
AIHA accredited laboratories (Refs. 56, 46). Commenters also suggested
applying the policy described in typical TSCA section 5(e) orders that
establish a New Chemical Exposure Limit under the TSCA New Chemicals
Program, which state that compliance with TSCA GLP Standards is not
required where exposure monitoring samples are analyzed by a laboratory
accredited by either: (A) the AIHA Industrial Hygiene Laboratory
Accreditation Program; or (B) another comparable program approved in
advance in writing by EPA (Refs. 33, 55, 49). Another commenter
reasoned the GLP Standards were not intended for air monitoring in a
workplace when compliance with such standards would mean that real-time
assessments could not be made, as air samples would need to be
processed and analyzed in a laboratory (Ref. 53).
EPA agrees with the commenter that the WCPP is incompletely served
by solely relying on the GLP Standard initially put forth in the 2023
PCE proposed rule. Given the concern from commenters regarding
potential increases in demand for professional safety services and
sampling laboratories having a negative impact due to anticipated
industry strain and sampling limitations (Refs. 33, 55, 49), EPA has
broadened the scope of laboratory accreditation accordingly. EPA has
considered this laboratory capacity issue, in addition to other
revisions for finalization in this rule, so that the additional
infrastructure is in place for the regulated community to successfully
implement the WCPP. For the final rule, EPA is requiring that exposure
samples be analyzed using an appropriate analytical method, and related
records retained, by a laboratory that complies with the GLP Standards
in 40 CFR part 792 or that otherwise maintains a relevant third-party
laboratory accreditation (e.g., under the AIHA Laboratory Accreditation
Programs, LLC Policy Module 2A/B/E of Revision 17.3), or other
analogous industry-recognized programs.
Another commenter stated that EPA's proposal did not make clear
that ``personal breathing zone'' air samples to monitor exposures are
to be taken without regard to respirator use. The commenter noted that
OSHA requires exposure monitoring to be conducted without regard to
respirator use (citing as an example OSHA's definition of ``employee
exposure'' at 29 CFR 1910.1052(b)) and asserted that this important
element of OSHA's monitoring program was omitted from EPA's proposal
(Ref. 58). EPA agrees with the commenter that exposure monitoring
should be conducted without regard to respiratory protection to inform
engineering control options and respiratory protection considerations.
Therefore, EPA is finalizing this rule to explicitly state that air
sampling is required to measure ambient concentrations for PCE without
taking respiratory protections into account when being performed. This
will ensure the highest degree of protection to potentially exposed
persons by logging accurate ambient air concentrations of PCE, thus
empowering owners or operators to appropriately consider the hierarchy
of controls.
As part of the WCPP, EPA also proposed to establish an ECEL action
level of 0.07 ppm as an 8-hour TWA for PCE. As described in Unit
IV.A.2.b. of the 2023 PCE proposed rule, air concentrations at or above
the action level would trigger more frequent periodic monitoring of
exposures to PCE, consistent with the action level approach utilized by
OSHA in the implementation of OSHA standards, although the values
differ due to differing statutory authorities. EPA proposed an action
level that would be half the 8-hour ECEL, which is in alignment with
the precedented approach established under most OSHA standards. EPA
solicited comment regarding an ECEL action level that is half the ECEL
and any associated provisions related to the ECEL action level when the
ECEL is significantly lower than the OSHA PEL. EPA also requested
comment on viability of current analytical methods and detection limits
for PCE sampling.
EPA received several comments regarding an action level that is
half the ECEL and the viability of detecting to the action level with
existing analytical methods. One commenter supported the establishment
of an action level that is
[[Page 103576]]
one-half the ECEL as this stratified approach will impose appropriate
controls based on the particulars of each workplace (Ref. 58). Other
commenters expressed concern regarding the proposed ECEL action level,
stating that the action level should not be included in the regulation
because of challenges to reliably measure to the proposed value and
suggesting EPA consider best practice for industrial hygiene exposure
assessment published by the AIHA (Refs. 33, 57). Commenters warned that
implementing a monitoring methodology for the proposed ECEL would not
be seamless because existing monitoring methods are not adequate. As an
example, commenters stated that the NIOSH 1003 method, as currently
validated, will not achieve the limit of detection required for
evaluating to the proposed ECEL or action limit (Refs. 33, 49).
Commenters stated that passive sampling methods cannot measure to below
the ECEL, and thus entities would need to rely on active sampling with
a pump with samples sent out to laboratories for analysis (Refs. 45,
47). Another commenter asserts that the proposed ECEL action level of
0.07 ppm is not detectable and stated that the best way to ensure
reliable and comparable results is to use a digital measuring device,
which can currently detect concentrations up to 10 ppm and are in
development to detect concentrations as low as 0.1 ppm, which is the
lowest on the global market (Ref. 59). Additionally, other commenters
stated that NIOSH recommends a detection limit of 10% of the
occupational exposure limit (Refs. 33, 49, 60).
EPA acknowledges the challenges of occupational personal breathing
zone monitoring to levels consistent with the ECEL action level and
ECEL. As noted earlier, EPA intends for the WCPP to align with, to the
extent possible, certain elements of the existing OSHA standards for
regulating toxic and hazardous substances under 29 CFR part 1910,
subpart Z and is therefore finalizing an action level different from
the proposed 0.07 ppm ECEL action level to support a trigger for more
frequent periodic monitoring. In consideration of public comment,
reasonably available information, and outreach, EPA has determined that
revising the ECEL action level to 0.10 ppm as an 8-hr TWA for PCE is
appropriate given the limits of detection and limits of quantification
for existing monitoring methods. EPA notes that while real-time
monitoring with a digital measuring device is not required for rule
compliance, EPA understands the practical benefits of real-time
occupational exposure monitoring. EPA also notes that the reliable
limits of quantification for available analytical methods (e.g., NIOSH
1003 and OSHA 5000) are below the ECEL action level of 0.10 ppm.
Additionally, as part of the WCPP, EPA proposed to require owners
and operators to re-monitor within 15 working days after receipt of any
exposure monitoring if results indicated non-detect or air monitoring
equipment malfunction, unless an Environmental Professional as defined
at 40 CFR 312.10 or a Certified Industrial Hygienist reviews the
monitoring results and determines re-monitoring is not necessary. EPA
received several comments disagreeing with the proposed requirement to
review non-detect air monitoring samples. The commenters stated that
the requirement is inconsistent with OSHA rules, is an unnecessary step
that adds no value to reduce risk to workers, and could be costly,
especially for smaller companies (Refs. 56, 32, 57, 33, 47, 48, 49).
One commenter suggested that EPA incorporate a six-sample rolling
average, as the statistical evaluation would incorporate ongoing
validation of exposure levels for a particular task and thus remove any
need for resampling based on a non-detect result.
EPA disagrees with commenters that expressed the opinion that re-
evaluating a non-detect result adds no value and is inappropriate.
While in some cases a non-detect result may accurately indicate that
the chemical is not present and that air concentrations are below the
ECEL action level, in other cases it may not necessarily imply
negligible occupational exposure to the chemical. For example,
interference from another chemical during sampling may result in an
incorrect result of non-detect. This interference may not be recognized
at the time of sampling or analysis. Owners and/or operators also may
not be using sampling techniques or analytical procedures that are
effective or appropriate for the particular chemical of interest. In
each of these cases, non-detect results, along with supporting
documentation about the sampling and analytical methods used to get
those results, is a meaningful part of the potentially exposed person's
exposure record required under the WCPP. The WCPP in the 2023 PCE
proposed rule and in this final rule does not require re-monitoring in
all cases. Re-monitoring may be necessary based on a professional
evaluation by an Environmental Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist. This flexibility allows owners or
operators options in terms of revisiting occupational sampling in the
event of a non-detect result, or evaluation by a qualified
professional.
From an owner/operator's perspective, a non-detect sampling result
when effective sampling and analysis procedures are used is valuable in
that it suggests effective implementation of exposure controls.
Potentially exposed persons may also use these records in discussions
with owner/operators, in collective bargaining situations, or in
compliance assistance inquiries to EPA or other federal agencies.
Exposure monitoring results may also improve overall workplace health
and reducing owner/operator liability in the effective detection,
treatment, and prevention of occupational disease or illness. All of
the above scenarios are valuable for owner/operators, potentially
exposed persons, and for effective mitigation of occupational
exposures. In consideration of these factors, EPA has removed the air
monitoring equipment malfunction from the monitoring activities that do
not require resampling based on professional evaluation by an
Environmental Professional or Certified Industrial Hygienist. While
professional discretion may be warranted in determining whether re-
monitoring is needed following results that indicate non-detect, EPA
has determined this is not appropriate in the event of air monitoring
equipment malfunction. This is due to the importance of air monitoring
in ensuring that the requirements of the WCPP are met, and the
importance of the WCPP in reducing risks from exposures to PCE in the
workplace. Monitoring results from malfunctioning air monitoring
equipment are not valid monitoring and therefore not sufficient to meet
the monitoring requirements under the WCPP.
Additionally, while statistical methods may be useful in
establishing and analyzing an occupational monitoring program, EPA is
not persuaded by information commenters presented in support of relying
on a six-sample rolling average of exposure measurements in place of
the proposed requirement to evaluate re-monitoring. See section 5.5.3
of the Response to Comments document for a more detailed response (Ref.
8). EPA may consider developing additional guidance regarding
occupational monitoring in the future. Therefore, after consideration
of public comment, EPA is finalizing the requirement to re-monitor
within 15 working days after receipt of any exposure monitoring if
results indicated non-detect, unless an
[[Page 103577]]
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. However, EPA agrees with comments that
raised concern that the 2023 PCE proposed rule lacked clarity on what
would suffice for justification that re-monitoring is not necessary,
and has therefore updated the recordkeeping requirements associated
with the WCPP exposures records required under 40 CFR 751.615(b)(1) to
require documentation of the determination by the Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist to be maintained as a record. Occupational monitoring (and
associated recordkeeping) is an area that EPA may develop guidance as
part of final rule implementation efforts.
In the 2023 PCE proposed rule, EPA proposed to require under the
WCPP that each owner or operator conduct additional exposure monitoring
whenever a change in the production, process, control equipment,
personnel, or work practices may reasonably be expected to result in
new or additional exposures at or above the ECEL action level, or when
the owner or operator has any reason to believe that new or additional
exposures at or above the ECEL action level occurred. In the event of
start-ups, shutdowns, spills, leaks, ruptures or other breakdowns that
may lead to employee exposure, EPA proposed to require that each owner
or operator conduct additional initial exposure monitoring to
potentially exposed persons (using personal breathing zone sampling)
after the cleanup of the spill or repair of the leak, rupture or other
breakdown. EPA is finalizing the requirement to conduct this additional
exposure monitoring, with a compliance timeframe requiring that this
monitoring be conducted within 30 days after the relevant change or
conclusion of the event and/or cleanup (see Unit IV.B.3.b.iii.), which
is a clarification of the proposal, in which a timeframe was not
specified.
As part of the WCPP exposure monitoring, EPA proposed to require
owners or operators to determine each potentially exposed person's
exposure by either taking a personal breathing zone air sample of each
potentially exposed person's exposure or by taking personal breathing
zone air samples that are representative of each potentially exposed
person's exposure group, which EPA proposed to mean 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. EPA received a comment that suggested EPA revise the proposed
definition of ``exposure group'' to more closely align with the similar
exposure group approach used by industrial hygienists to refer to a
group of workers who have common risks and similar exposure profiles
(Ref. 56). EPA agrees that the definition of ``exposure group'' should
align with standard practice for occupational safety and industrial
hygiene and is therefore finalizing the definition of ``exposure
group'' in 40 CFR 751.5 to mean a group of potentially exposed persons
with a similar exposure profile to a chemical substance or mixture
based on the substantial similarity of tasks performed, the manner in
which the tasks are performed, and the materials and processes with
which they work.
2. Designated Representative and Workplace Participation
As part of the WCPP in Unit IV.A.2.e.iii. of the 2023 PCE proposed
rule, EPA proposed to require that owners or operators (i.e., any
person who owns, leases, operates, controls, or supervises a workplace
covered by the rule) provide potentially exposed persons or their
designated representatives regular access to the exposure control
plans, exposure monitoring records, and PPE program implementation and
documentation. Additionally, EPA proposed to require that owners or
operators document the notice to and ability of any potentially exposed
person that may reasonably be affected by PCE inhalation or dermal
exposure to readily access the exposure controls plans, facility
exposure monitoring records, PPE program implementation, or any other
information relevant to PCE inhalation exposure in the workplace. EPA
also requested comment on how owners and operators could engage with
potentially exposed persons on the development and implementation of an
exposure control plan and PPE program. Additional details of EPA's
worker participation proposal can be found in Unit IV.A.2.e. of the
2023 PCE proposed rule.
EPA received public comment on the role of designated
representatives in the WCPP. One commenter, a group of labor unions,
urged EPA to incorporate requirements similar to OSHA's access standard
at 29 CFR 1910.1020 (titled, ``Access to employee exposure and medical
records'') in EPA's proposed requirements at 40 CFR 751.613 to ensure
that exposure information is promptly and fully shared with both
potentially exposed persons and their designated representatives (Ref.
58). The commenter pointed out that while the preamble to the 2023 PCE
proposed rule stated that EPA was proposing to provide designated
representatives regular access to specified information, the proposed
regulatory text at 40 CFR 751.613(b)(4) did not do so. The commenter
also suggested that EPA include a requirement that employers provide
employees or their designated representatives an opportunity to observe
monitoring events. The commenter observed that workers and their
designated representatives have a critical role to play in ensuring
effective control of toxic substances and further noted that, often,
unions are the organizations with expertise in understanding
occupational exposure information. The commenter also urged EPA to
require that owners and operators consult with workers and their
designated representatives in developing and implementing their plans.
Following review of the comments received, EPA recognizes the
importance of having the ability for potentially exposed persons and
their designated representative(s), such as labor union
representatives, to observe exposure monitoring and have prompt access
to exposure records. EPA additionally recognizes that, in some
instances, individual workers may be hesitant to ask owners or
operators for information relating to their chemical exposure or may be
less familiar with discipline-specific industrial hygiene practices.
EPA determined that it is appropriate in this final rule to revise to
some extent the requirements regarding designated representatives
included in the proposal, consistent with existing OSHA precedent in
certain 29 CFR part 1910, subpart Z regulations, to allow designated
representatives the ability to observe occupational exposure monitoring
and have access to exposure monitoring records. In EPA's final rule,
the WCPP includes a requirement that owners and operators provide
potentially exposed persons or their designated representatives an
opportunity to observe any exposure monitoring that is designed to
characterize their exposures and is conducted under the WCPP. With
respect to facilities classified in the interest of national security,
only persons authorized to have access to such facilities will be
allowed to observe exposure monitoring.
EPA is also finalizing a requirement that designated
representatives have access to relevant exposure records, similar to
provisions in certain OSHA
[[Page 103578]]
regulations under 29 CFR part 1910, subpart Z, such as 29 CFR 1910.1200
and 29 CFR 1910.1020. EPA is requiring owners and operators to notify
potentially exposed persons and their designated representatives of the
availability of the exposure control plan and associated records of
exposure monitoring and PPE program implementation within 30 days of
the date that the exposure control plan is completed and at least
annually thereafter. EPA is also requiring, consistent with the
proposed requirement for notification of exposure monitoring results,
that the notice of the availability of the exposure control plan and
associated records be provided in plain language writing to each
potentially exposed person in a language that the person understands 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. While EPA encourages owners or operators to
consult with persons that have potential for exposure and their
designated representatives on the development and implementation of the
exposure control plan, EPA has determined that it is not necessary to
include this as a requirement in the final rule because OSHA does not
typically require consultations with designated representatives.
However, EPA believes that the notification of the exposure control
plan and associated records may help facilitate participation from
potentially exposed persons and their designated representatives in the
implementation and further development of that plan.
In this final rule, EPA is defining ``designated representative''
in 40 CFR 751.5 to mean any individual or organization to whom a
potentially exposed person gives explicit, written authorization to
exercise a right of access. A recognized or certified collective
bargaining agent must be treated automatically as a designated
representative without regard to written authorization. Additionally,
with respect to federal employees, EPA, like OSHA at 29 CFR 1960.2(e),
will interpret these designated representative requirements consistent
with the Federal Service Labor Management Relations Statute (5 U.S.C.
71), or collective bargaining or other labor-management arrangements
that cover the affected employees.
Should a request be initiated for such records by the potentially
exposed person or their designated representative(s), the owner or
operator will be required to provide the specified records at a
reasonable time, place, and manner, analogous to provisions outlined in
OSHA's 29 CFR 1910.1020(e)(1)(i). If the owner or operator is unable to
provide the requested records within 15 working days, the owner or
operator must, within those 15 working days, inform the potentially
exposed person or designated representative(s) requesting the record of
the reason for the delay and the earliest date when the record can be
made available. Additionally, in the event that a designated
representative is observing exposure monitoring, the owner or operator
must ensure that designated representatives are provided with PPE
appropriate for the observation of monitoring. Finally, this rule
requires owners or operators to provide notice to potentially exposed
persons and their designated representatives of exposure monitoring
results and of the availability of the exposure control plan and
associated records. For purposes of this requirement, the owner or
operator is only required to provide notice to those designated
representatives that the owner or operator is aware of, such as
representatives designated in writing or a recognized collective
bargaining agent for the owner or operator's own employees.
3. Other Changes to the WCPP
As part of the WCPP in the 2023 PCE proposed rule, EPA proposed
various requirements for owners or operators to provide PPE, including
respiratory protection and dermal protection, to potentially exposed
persons and to establish a PPE program. For greater clarity in this
final rule, EPA has revised the PPE requirements with respect to the
cross-references to the relevant OSHA regulations. While the language
appears different than the requirements included in the 2023 PCE
proposed rule, it remains EPA's intention that owners and operators
implement PPE programs that are consistent with OSHA requirements. The
PPE requirements as part of the WCPP in this final rule are described
in Unit IV.B.6.
D. Other Changes
EPA is slightly modifying the provisions related to the de minimis
regulatory threshold in the 2023 PCE proposed rule, where EPA proposed
that products containing PCE at concentrations less than 0.1% by weight
are not subject to the prohibitions. EPA requested comment on the de
minimis concentration limit of PCE in products or formulations and
received numerous comments in support of the inclusion of a de minimis
regulatory threshold (Refs. 48, 32, 46, 33, 61, 56, 47, 55, 62, 53, 54,
31, 63). One commenter urged EPA to make clear that the proposed de
minimis exemption applies to all the provisions in the 2023 PCE
proposed rule, and not just the prohibitions (Ref. 54). Some commenters
expressed opposition to the de minimis level identified because they
state EPA has not shown that a de minimis concentration is protective
of workers (Refs. 64, 65, 66). EPA's approach for a de minimis
concentration of 0.1% for PCE is consistent with OSHA's Hazard
Communication Standard, as urged by several commenters who asserted
that consistency with the existing hazard communication framework is
important to avoid companies being out of compliance with EPA's
regulations without their knowledge, or having to engage in impractical
and burdensome changes to hazard communication programs that are not
necessary to protect against unreasonable risk (Ref. 33, 47, 48, 55).
OSHA recently reaffirmed its approach of 0.1% threshold for carcinogens
with its 2024 modification of its Hazard Communication Standard (89 FR
44144, May 20, 2024). The OSHA Hazard Communication standard, at 29 CFR
1910.1200, which requires employers to communicate to employees and
downstream employers about the hazards of chemicals employees are
exposed to, including through safety data sheets, defines ``health
hazard'' as ``a chemical which is classified as posing one of the
following hazardous effects: acute toxicity (any route of exposure);
skin corrosion or irritation; serious eye damage or eye irritation;
respiratory or skin sensitization; germ cell mutagenicity;
carcinogenicity; reproductive toxicity; specific target organ toxicity
(single or repeated exposure); or aspiration hazard'' (29 CFR
1910.1200(c)). The criteria for determining whether a chemical is
classified as a health hazard are detailed in Appendix A to 29 CFR
1910.1200--Health Hazard Criteria. Section A.6.3.1 of Appendix A of 29
CFR 1910.1200 indicates that a substance is considered a health hazard
if it includes greater than 0.1% of a substance that, like PCE, is
classified as a carcinogen. OSHA's Hazard Communication Standard is
intended to be consistent with the United Nations Globally Harmonized
System of Classification and Labelling of Chemicals (29 CFR
1910.1200(a)(1); 89 FR 44144, May 20, 2024). Other EPA programs, such
as the Toxics Release Inventory (TRI) program, have adopted a de
minimis threshold of 0.1% for
[[Page 103579]]
chemicals which are defined as carcinogens or as a potential carcinogen
under the National Toxicology Program, International Agency for
Research on Cancer, or OSHA, with limited exceptions not relevant to
PCE (see 40 CFR 372.38(a)).
In consideration of public comment and the implementability of the
PCE rule, as well as the analysis described in Unit V.A. of the 2023
PCE proposed rule, EPA is finalizing as proposed a de minimis threshold
of 0.1%, which EPA is referring to in this final rule as a regulatory
threshold, so that products containing PCE at concentrations less than
0.1% by weight are not subject to the prohibitions of this final rule,
and is also adding clarification that products below the regulatory
threshold are not subject to other restrictions of this final rule.
While EPA conducted analysis regarding residual amounts of PCE in
products (described in Unit V.A.1. of the 2023 PCE proposed rule),
which confirmed that the use of the 0.1% value for carcinogens was an
appropriate cut off, consistent with the OSHA's Hazard Communication
Standard. EPA generally expects to align with the OSHA's Hazard
Communication Standard approach regarding threshold amounts of
chemicals going forward, with some exceptions as warranted by chemical-
specific considerations (Ref. 67). EPA is confident that adopting a
regulatory threshold of 0.1% for chemicals which are defined as
carcinogens or as a potential carcinogen will increase regulatory
certainty and enhance compliance. The manufacturing (including import),
processing, and distribution in commerce of products that contain PCE
at concentrations equal to or above the regulatory threshold of 0.1%
are still subject to the prohibitions and restrictions of this final
rule, regardless of the concentration of PCE in the end product.
As an additional change, EPA has revised its proposed description
of industrial and commercial use of PCE as a laboratory chemical to
provide additional clarity as suggested by a commenter (Ref. 62). The
revised description for industrial and commercial use as a laboratory
chemical appears in Unit IV.C.1. Similarly, for greater clarity and in
response to comment that suggested EPA include terminology for
``airless degreasers'' in the final rule, EPA has revised its proposed
description of industrial and commercial use as solvent for closed-loop
batch vapor degreasing by clarifying that this use includes use of
airless degreasers (Ref. 30). EPA has also revised the proposed
description for industrial and commercial use of PCE in maskant for
chemical milling to provide additional clarity as recommended by a
commenter (Ref. 31). Additionally, in response to a comment that EPA
should ensure that uses of PCE required for environmental, health, and
safety permit compliance, such as performance testing requirements in
the NESHAP for hazardous waste combustors (HWCs) (40 CFR part 63,
subpart EEE), are permitted to continue and are not inadvertently
prohibited, EPA has revised its proposed description of disposal (Ref.
55). For purposes of this final rule, disposal includes the use of PCE
to comply with requirements for HWC facilities under the Clean Air Act
(CAA) and the Resource Conservation and Recovery Act (RCRA) (40 CFR
parts 260 and 270), including use of PCE as a representative principal
organic hazardous constituent (POHC) in destruction and removal
efficiency (DRE) tests required under 40 CFR 63.1216-63.1221 and for
chlorine feedrate operating conditions during comprehensive and
confirmatory performance tests required under 40 CFR 63.1207(g)(1) and
40 CFR 63.1207(g)(2). The revised descriptions for industrial and
commercial use as solvent for batch vapor degreasing, industrial and
commercial use in maskant for chemical milling, and for disposal appear
in Unit IV.B.1.
Additionally, in this final rule, EPA is not finalizing as proposed
to amend the general provision of 40 CFR part 751, subpart A, to define
``authorized person,'' ``owner or operator,'' ``potentially exposed
person,'' ``regulated area,'' and ``retailer,'' because those
definitions are finalized in the TSCA section 6 final rule for
methylene chloride (89 FR 39254, May 8, 2024) (FRL-8155-01-OCSPP) 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. In
response to one commenter that suggested EPA describe ``distribution in
commerce'' in the preamble, EPA is finalizing the definition for
``distribute in commerce'' in Sec. 751.603 so that it has the same
meaning as in section 3 of the Act, except that the term does not
include retailers for purposes of Sec. Sec. 751.613 and 751.615 (Ref.
33).
IV. Provisions of the Final Rule
EPA intends that each provision of this rulemaking be severable. In
the event of litigation staying, remanding, or invalidating EPA's risk
management approach for one or more conditions of use in this rule, EPA
intends to preserve the risk management approaches in the rule for all
other conditions of use to the fullest extent possible. The Agency
evaluated the risk management options in TSCA section 6(a)(1) through
(7) for each condition of use and generally EPA's regulation of one
condition of use to address its contribution to the unreasonable risk
from PCE functions independently from EPA's regulation of other
conditions of use, which may have different characteristics leading to
EPA's risk management decisions. Further, the Agency crafted this rule
so that different risk management approaches are reflected in different
provisions or elements of the rule that are capable of operating
independently. Accordingly, the Agency has organized the rule so that
if any provision or element of this rule is determined by judicial
review or operation of law to be invalid, that partial invalidation
will not render the remainder of this rule invalid.
There are many permutations of this. For example, as discussed in
Unit IV.D., this final rule prohibits the industrial and commercial use
of PCE in dry cleaning and spot cleaning, and also the industrial and
commercial use of PCE in general aerosol degreasing/cleaning products
that contain PCE (although a subset of this use is permitted to
continue under specific prescriptive controls or the WCPP as described
in Unit III.A.3.b.). For use of PCE in general aerosol degreasing/
cleaning products as well as dry cleaning, EPA's risk management
approach is prohibition. To the extent that a court were to find that
EPA lacked substantial evidence to support its prohibition of general
aerosol degreasing/cleaning or otherwise found legal issues with EPA's
approach to that condition of use, it would have no bearing on other
similarly situated conditions of use such as dry cleaning unless the
specific issue also applies to the particular facts associated with dry
cleaning. This is reflected in the structure of the rule, which
describes these specific prohibitions separately by compliance date.
As another example, for industrial and commercial use of PCE as a
processing aid in catalyst regeneration in petrochemical manufacturing
and industrial and commercial use of PCE in automotive care products
(e.g., engine degreaser and brake cleaner), EPA took different risk
management approaches--application of the WCPP for the industrial and
commercial use of PCE as a processing aid in catalyst regeneration in
petrochemical manufacturing and prohibition for industrial and
commercial use in automotive care products. To the extent that a court
were to find a legal issue with EPA's
[[Page 103580]]
approach to the WCPP, impacting industrial and commercial use as a
processing aid in catalyst regeneration in petrochemical manufacturing,
it would have no bearing on EPA's decision to prohibit the industrial
and commercial use in automotive care products, and vice versa. This is
reflected in the structure of the rule, which organizes the
prohibitions and the WCPP into different sections of the regulation.
EPA also intends all TSCA section 6(a) risk management elements in
this rule to be severable from each regulatory exclusion from those
requirements, including each TSCA section 6(g) exemption. EPA has the
authority to promulgate TSCA section 6(g) exemptions ``as part of a
rule promulgated under [TSCA section 6(a)].'' However, EPA's risk
management decisions under TSCA sections 6(a) and 6(c) are independent
from EPA's consideration of whether it is appropriate, based on the
factors in TSCA section 6(g), to exempt specific conditions of use from
the requirements of the TSCA section 6(a) risk management elements in
the rule. In other words, EPA first decides whether and how to regulate
each condition of use, per TSCA sections 6(a) through (c), and only
then determines whether an exemption under TSCA section 6(g) is
appropriate. Accordingly, the underlying TSCA section 6(a) risk
management elements would not be impacted if a TSCA section 6(g)
exemption is determined by judicial review or operation of law to be
invalid. Rather, the exempted condition of use would become subject to
the underlying TSCA section 6(a) risk management element(s). Similarly,
to the extent a court were to find a legal issue with the regulatory
threshold established in the rule, the underlying risk management
requirements would not be impacted. Rather, the excluded products would
become subject to the underlying TSCA section 6(a) risk management
requirements applicable to the condition of use. EPA further notes that
the specific examples of severability described in this Unit are not
intended to be exhaustive, but rather illustrative of a wide variety of
scenarios that reflect EPA's overarching intent that each provision of
this rulemaking be severable.
To that end, EPA acknowledges that after the issuance of this rule,
Federal agencies, their contractors, and other related entities may
become aware of important information which indicates a particular use,
that would otherwise be prohibited, could meet the criteria of section
6(g) or the requirements of a WCPP. EPA also notes that there are
multiple avenues to ask EPA to revisit issues in this TSCA section 6(a)
rulemaking, both before and after the mandatory compliance dates are
set consistent with TSCA section 6(d). EPA has the authority under TSCA
section 6(g) to consider whether a time limited exemption is
appropriate and consistent with TSCA section 6(g)(1), could
expeditiously promulgate such exemptions independently from this
rulemaking, including consideration of emergency or interim rulemaking.
EPA has initiated a notice of proposed rulemaking for public comment on
this topic, included in the Spring 2024 Regulatory Agenda (RIN 2070-
AL17). Additionally, any person could petition EPA to request that EPA
issue or amend a rule under TSCA section 6.
A. Applicability
This final rule sets prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal of PCE to prevent unreasonable risk of
injury to health in accordance with TSCA section 6(a), 15 U.S.C.
2605(a).
Additionally, pursuant to TSCA section 12(a)(2), this rule applies
to PCE even if being manufactured, processed, or distributed in
commerce solely for export from the United States because EPA has
determined that PCE presents an unreasonable risk to health within the
United States. Several commenters expressed concern that an unclear
statement in the 2023 PCE proposed rule preamble, and a proposed
regulatory requirement for downstream notification of permissible
purposes for distribution in commerce, appeared to indicate that
manufacture, processing, and distribution for export would be
prohibited under the 2023 PCE proposed rule if the intended use in the
destination country is prohibited in the United States, even if it is
permissible under other risk mitigation rules in the destination
country (Refs. 47, 33, 55, 49, 68). This was not EPA's intent. Because
distribution in commerce did not contribute to EPA's unreasonable risk
determination for PCE, and because this final rule permits
manufacturing and processing, including recycling, for various uses to
continue under the WCPP, EPA intends this final rule to permit
manufacturing and processing in compliance with the WCPP for export, as
well as distribution in commerce for export, without regard for the
intended use in the destination country. EPA has clarified the
regulatory text accordingly.
As discussed in Unit III.D., EPA is finalizing a regulatory
threshold of 0.1% to account for impurities and the unintended presence
of PCE (in the 2023 proposed rule, this was referred to as a de minimis
threshold). In other words, the provisions of this rulemaking only
apply when PCE is present in a formulation at 0.1% or greater.
Additionally, the provisions of this final rule only apply to chemical
substances as defined under TSCA section 3. Notably, TSCA section 3(2)
excludes from the definition of chemical substance ``any food, food
additive, drug, cosmetic, or device (as such terms are defined in
Section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
321]) when manufactured, processed, or distributed in commerce for use
as a food, food additive, drug, cosmetic, or device'' and ``any
pesticide (as defined in the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136 et seq.]) when manufactured, processed,
or distributed in commerce for use as a pesticide.'' Additional details
regarding TSCA statutory authorities can be found in section 2 of the
response to comments document (Ref. 8).
EPA uses the term ``potentially exposed person'' in Unit IV. and in
the regulatory text to include workers, occupational non-users,
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 or specific prescriptive
controls would apply. (EPA notes that this definition is intended to
apply to occupational workspaces as part of implementation of the WCPP
and other restrictions, and recognizes that other individuals or
communities may be exposed to PCE as consumers, members of fenceline
communities, or members of the general population.) For certain
conditions of use, EPA requires a comprehensive WCPP or specific
prescriptive controls to address the unreasonable risk from PCE to
workers directly handling the chemical or in the area where the
chemical is being used. Similarly, the 2020 Risk Evaluation for PCE
(Ref. 1) did not distinguish between employers, contractors, or other
legal entities or businesses that manufacture, process, distribute in
commerce, use, or dispose of PCE. For this reason, EPA uses the term
``owner or operator'' to describe the entity responsible for
implementing the WCPP or specified prescriptive controls in any
workplace where an applicable condition of use is identified in Unit
IV. and subject to the WCPP or prescriptive controls is occurring. The
term includes any person who owns, leases, operates, controls, or
supervises such a workplace. While
[[Page 103581]]
owners or operators remain responsible for ensuring compliance with the
WCPP or prescriptive controls requirements in the workplace, they may
contract with others to provide training or implement a respiratory
protection program, for example. EPA is also clarifying its intent that
for the provisions in this rule, any requirement for an owner or
operator, or an owner and operator, is a requirement for any individual
that is either an owner or an operator.
EPA emphasizes that this approach is essential for addressing the
unreasonable risk presented by PCE, including to individuals who may
not be covered by OSHA requirements, such as volunteers, self-employed
persons, and state and local government workers who are not covered by
a state plan. EPA uses the term ``owner or operator'' in TSCA programs
because the term is used in other EPA programs to describe persons with
responsibilities for implementing statutory and regulatory requirements
at particular locations. See, for example, CAA section 113, 42 U.S.C.
7412, which defines ``owner or operator'' as a person who owns, leases,
operates, controls, or supervises a stationary source. There is a
similar definition in section 306 of the Clean Water Act (CWA), 33
U.S.C. 1316. EPA understands that the use of this term may result in
multiple persons' bearing responsibility for complying with provisions
of this final rule, including the WCPP. However, this is also the case
for workplaces regulated by OSHA, including those regulated under
OSHA's general industry standards at 29 CFR part 1910. OSHA's 1999
Multi-Employer Citation Policy explains which employers should be cited
for a hazard that violates an OSHA standard (Ref. 69). The OSHA Policy
describes four different roles that employers may fill at a workplace
and describes who should be cited for a violation based on factors such
as whether the employer created the hazard, had the ability to prevent
or correct the hazard, and knew or should have known about the hazard.
More than one employer may be cited for the same hazard. This final
rule will have similar results, in that more than one owner or operator
may be responsible for compliance.
The OSHA multi-employer citation policy is an example of a guidance
governing situations where more than one regulated entity is present.
EPA has received several requests for clarification of the
applicability of the term ``owner or operator'' to sites where more
than one entity owns, leases, or controls a workplace where a PCE
condition of use is ongoing and where implementation of the WCPP or
prescriptive controls is required. EPA understands that there are a
wide variety of situations where these questions could arise, and plans
to issue guidance consistent with TSCA authorities that explains how
EPA will approach the issue of responsibility for implementation of,
and compliance with, the WCPP requirements in practice.
B. Workplace Chemical Protection Program (WCPP)
1. Applicability
EPA is finalizing the WCPP for most of the conditions of use for
which it was proposed, as well as for additional conditions of use for
which prohibition was proposed. EPA has removed from the WCPP two
conditions of use proposed to be included, as described in Unit
III.A.1. EPA's descriptions of changes from the 2023 PCE proposed rule
are in Unit III. and EPA's rationale for why the WCPP addresses the
unreasonable risk for certain conditions of use is in Unit V. of the
2023 PCE proposed rule. EPA is additionally requiring that uses
receiving an exemption under TSCA section 6(g), as outlined in Unit
IV.F., comply with the WCPP to the extent feasible.
EPA is finalizing the WCPP for the following conditions of use
where manufacture and processing are not otherwise prohibited: domestic
manufacturing; import; processing as a reactant/intermediate;
processing into formulation, mixture, or reaction product; processing
by repackaging; recycling; 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 in maskant for chemical milling; industrial and
commercial use in solvent-based adhesives and sealants; industrial and
commercial use as a processing aid in catalyst regeneration in
petrochemical manufacturing; industrial and commercial use as a
processing aid in sectors other than petrochemical manufacturing;
industrial and commercial use for cold cleaning of tanker vessels; and
disposal. This Unit provides a description of the uses subject to the
WCPP to assist with compliance.
a. Manufacturing (Includes 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. For purposes of this rule, 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. 70).
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 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 processed as a reactant in the production of HFCs,
hydrochlorofluorocarbons, and chlorofluorocarbons. 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
This condition of use refers to when PCE is added or incorporated
into a product (or product mixture) prior to further distribution of
the product, including in cleaning and degreasing products, adhesive
and sealant products, paint and coating products, and other chemical
products and preparations.
iii. Processing by Repackaging
This condition of use refers to the preparation of PCE for
distribution in commerce in a different form, state, or quantity. This
includes transferring the chemical from a bulk container into smaller
containers.
iv. Recycling
This condition of use refers to the process of treating generated
waste streams (i.e., which would otherwise be disposed of as waste)
that are collected, either onsite or transported to a third-party site,
for commercial purpose. Waste solvents can be restored to a condition
that permits reuse via solvent reclamation/recycling. The recovery
process may involve an initial vapor recovery or mechanical separation
step followed by distillation, purification, and final packaging.
[[Page 103582]]
c. Industrial and Commercial Uses
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 systems.
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 or airless vapor degreasing
systems.
iii. 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. This condition of use
includes use of peelable maskant to act as temporary protection during
transportation.
iv. 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.
v. 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.
vi. Industrial and Commercial Use as a Processing Aid in Sectors Other
Than Petrochemical Manufacturing
This condition of use refers to the industrial and commercial use
of PCE outside of petrochemical manufacturing to improve the processing
characteristics or the operation of process equipment or to alter or
buffer the pH of the substance or mixture, when added to a process or
to a substance or mixture to be processed. For example, PCE is used in
pesticide, fertilizer and other agricultural manufacturing 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 not intended to remain in or
become part of the product or product mixture or affect the function of
a substance or article created.
vii. Industrial and Commercial Use as Solvent for Cold Cleaning of
Tanker Vessels
This condition of use refers to the industrial and commercial use
of PCE as a non-boiling solvent in cold cleaning to remove dirt, oils,
greases, and other surface contaminants from tanker vessels.
d. Disposal
This condition of use refers to the process of disposing waste
streams of PCE that are collected either onsite or and transported to a
third-party site for treatment or their final disposition, such as
waste incineration or landfilling. This condition of use includes the
use of PCE to comply with requirements for HWC facilities under the CAA
(40 CFR part 63, subpart EEE) and RCRA (40 CFR parts 260 and 270),
including as a representative POHC in DRE tests required under 40 CFR
63.1216-63.1221 and for chlorine feedrate operating conditions during
comprehensive and confirmatory performance tests required under 40 CFR
63.1207(g)(1) and 40 CFR 63.1207(g)(2).
2. Overview
The WCPP for PCE encompasses an inhalation exposure limit and
action level, DDCC, 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 have some
flexibility, within the parameters outlined in this unit, regarding how
they prevent exceedances of the identified EPA exposure limit
thresholds or prevent direct dermal contact. In the case of PCE,
meeting the EPA exposure limit threshold and implementing the DDCC
requirements for certain occupational conditions of use would address
the unreasonable risk to potentially exposed persons from inhalation
and dermal exposure.
EPA is finalizing the WCPP requirements to start to take effect by
December 15, 2025 for non-Federal owners or operators, or by June 21,
2027 for Federal agencies and Federal contractors acting for or on
behalf of the Federal government, or within 30 days of introduction of
PCE into the workplace, whichever is later, at which point entities
would be required to complete initial monitoring (as described in Unit
IV.B.3.b.). Additionally, EPA requires that each owner or operator
ensure that no person is exposed to an airborne concentration of PCE
that exceeds the ECEL as an 8-hour TWA, including by providing
respirators to potentially exposed persons in the regulated area, no
later than March 13, 2026 for non-Federal owners or operators, or no
later than September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or
beginning four months after introduction of PCE into the workplace,
whichever is later. EPA also requires each owner or operator to ensure
all persons are separated, distanced, physically removed, or isolated
from direct dermal contact with PCE, including by providing dermal PPE,
by March 13, 2026 for non-Federal owners or operators, or no later than
September 20, 2027 for Federal agencies and Federal contractors acting
for or on behalf of the Federal government. EPA also requires
implementation of any needed exposure controls based on initial
monitoring and development of an exposure control plan, which requires
consideration and documented application of the hierarchy of controls,
no later than June 7, 2027 for non-Federal owners or operators, or
December 20, 2027 for Federal agencies and Federal contractors acting
for or on behalf of the Federal government (as described in Unit
IV.B.5).
EPA's implementation of the requirement to meet an ECEL as part of
a WCPP aligns with, to the extent possible, certain elements of the
existing OSHA standards for regulating toxic and hazardous substances
under 29 CFR part 1910, subpart Z. However, EPA is finalizing as
proposed a new, lower occupational exposure limit, derived from the
TSCA 2020 Risk Evaluation for PCE (Refs. 1, 71). For PCE, this final
rule
[[Page 103583]]
will eliminate the unreasonable risk from PCE contributed to by the
conditions of use subject to the WCPP, enable continued industry use
where appropriate, and provide the familiarity of a pre-existing
framework for the regulated community.
EPA's requirements include specific exposure limits and ancillary
requirements necessary for successful implementation of an ECEL as part
of a WCPP. Taken together, these WCPP requirements apply to the extent
necessary so that the unreasonable risk from PCE under the conditions
of use listed earlier in this Unit would no longer be presented.
Unit IV. includes a summary of the WCPP, including a description of
the finalized exposure limits including an ECEL and ECEL action level;
implementation requirements including monitoring requirements; a
description of potential exposure controls in accordance with the
hierarchy of controls, including engineering controls, administrative
controls, and PPE as it relates to respirator selection; and additional
finalized requirements for recordkeeping and workplace participation.
Additionally, Unit IV. describes DDCC requirements for PCE, including
potential exposure controls, which consider the hierarchy of controls;
PPE as it relates to dermal protection; and additional requirements
finalized for recordkeeping. Unit IV. also describes compliance
timeframes revised from the 2023 PCE proposed rule, changes by EPA to
certain provisions of the WCPP based on public comments, and addition
of new provisions in the WCPP based on public comments used to inform
this final rule.
3. Existing Chemical Exposure Limit (ECEL)
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 requiring an ECEL and ancillary
requirements for all of the conditions of use identified in Unit
IV.B.1. except recycling and disposal. As described in Unit V.A.1.b. of
the 2023 PCE proposed rule, for recycling and disposal, EPA did not
identify human health risk from inhalation exposure as contributing to
the unreasonable risk of PCE and is therefore not requiring an ECEL and
related implementation measures identified in Unit IV. for recycling
and disposal activities.
a. ECEL and ECEL Action Level (AL)
EPA is finalizing as proposed an ECEL under TSCA section 6(a) of
0.14 ppm (0.98 mg/m3) as an 8-hour TWA based on the chronic non-cancer
human equivalent concentration for neurotoxicity. EPA has determined
that ensuring exposures remain at or below the 8-hour TWA ECEL of 0.14
ppm will eliminate the unreasonable risk of injury to health resulting
from acute and chronic inhalation exposures for certain occupational
conditions of use of PCE (Ref. 71). If ambient exposures are kept at or
below the 8-hour TWA ECEL of 0.14 ppm, a potentially exposed person
will be protected against the effects described in Unit IV., including
effects resulting from acute exposure, chronic non-cancer effects, and
cancer. EPA is finalizing requirements that each owner or operator
ensure that exposure to PCE does not exceed the ECEL as an 8-hour TWA
for all potentially exposed persons within 450 days after publication
of the final rule or beginning four months after introduction of PCE
into the workplace, whichever is later.
EPA is finalizing an ECEL action level at 0.10 ppm as an 8-hour
TWA, which is a modification from the ECEL action level EPA proposed,
as described in Unit III.C.1. Below the ECEL action level, certain
compliance activities, such as periodic monitoring, would be required
less frequently, as described further in this Unit. In this way, EPA's
WCPP for PCE is consistent with the familiar framework that is in place
in OSHA standards for regulating toxic and hazardous substances under
29 CFR part 1910, subpart Z that establish an action level, although
the values differ due to differing statutory authority. As explained by
OSHA, the action level provides employers and employees with greater
assurance that their employees will not be exposed to concentrations
above the PELs (Ref. 72).
In summary, EPA is finalizing with slight modification that owners
or operators must ensure the airborne concentration of PCE within the
personal breathing zone of potentially exposed persons remains at or
below 0.14 ppm as an 8-hour TWA ECEL, with an action level finalized as
0.10 ppm as an 8-hour TWA. For purposes of this rulemaking, the
personal breathing zone is consistent with how OSHA defines it as a
hemispheric area forward of the shoulders within a six-to-nine-inch
radius of a worker's nose and mouth and requires that exposure
monitoring air samples be collected from within this space (Ref. 73).
EPA is finalizing the ECEL for certain occupational conditions of use
to ensure that no person is exposed to inhalation of PCE in excess of
these concentrations resulting from those conditions of use. For the
identified conditions of use for which the concentration thresholds are
being finalized, EPA recognizes that the regulated community has the
ability to detect the values for the ECEL and ECEL action level because
of viable detection limits and analytical methods of PCE for monitoring
devices that are available in commerce, currently in use, and approved
by EPA, NIOSH, and OSHA, which can range from <=0.5 parts per billion
(ppb) to 9 ppm (Ref. 71). Based on the ECEL and ECEL action level
established in this final rule, EPA confirmed there are adequate
sampling methods available for personal breathing zone monitoring for
PCE based on consultation with NIOSH and OSHA (Refs. 74, 75). While
sampling methods may have some limitations, EPA notes that new and
alternative methods may be developed as long as they are consistent
with the performance criteria in the final PCE rule (accurate to a
confidence level of 95% and are within (plus or minus) 25% of airborne
concentrations of PCE above the 8-hour TWA ECEL). Multiple existing
methods are available. OSHA, NIOSH, and EPA have available sampling
methods (both active and passive) with sufficient limits of
quantification to support WCPP implementation.
b. Monitoring Requirements
i. Exposure Sampling
Initial monitoring for PCE is critical for establishing a baseline
of exposure for potentially exposed persons; similarly, periodic
exposure monitoring assures continued compliance over time so that
potentially exposed persons are not exposed to levels that would result
in an unreasonable risk of injury to health. Exposure monitoring could
be suspended if certain conditions described in Unit IV. are met. Also,
in some cases, a change in workplace conditions with the potential to
impact exposure levels would warrant additional monitoring, which is
also described.
EPA is finalizing with modifications from proposal its requirement
that owners or operators determine each potentially exposed person's
exposure by either taking a personal breathing zone air sample of each
potentially exposed person's exposure or by taking personal breathing
zone air samples that are representative of each potentially exposed
person with a similar exposure profile to a chemical substance or
mixture based on the substantial
[[Page 103584]]
similarity of tasks performed, the manner in which the tasks are
performed, and the materials and processes with which they work
(hereinafter identified as an ``exposure group''). Personal breathing
zone air samples are representative of the 8-hour TWA of all
potentially exposed persons in an exposure group if the samples are of
the full shift-exposure of at least one person who represents the
highest potential PCE exposures in that exposure group. In addition,
the initial monitoring will be required when and where the operating
conditions are best representative of each potentially exposed person's
work-shift exposures. Personal breathing zone air samples taken during
one work shift may be used to represent potentially exposed person
exposures on other work shifts where the owner or operator can document
that the tasks performed and conditions in the workplace are similar
across shifts. Additionally, air sampling is required to measure
ambient concentrations for PCE without taking respiratory protections
into account as sampling is being performed. For purposes of exposure
monitoring requirements, owners and operators are only required to
monitor potentially exposed persons that are expected to be present in
the workplace.
EPA is also finalizing requirements that the owner or operator
ensure that their exposure monitoring methods are accurate to a
confidence level of 95% and are within (plus or minus) 25% of airborne
concentrations of PCE above the 8-hour TWA ECEL. To ensure compliance
for monitoring activities, EPA is finalizing recordkeeping requirements
and will require that owners or operators document their choice of
monitoring method outlined in this Unit. As described in Unit III.C.1.,
EPA is finalizing the requirement that owners or operators meet certain
documentation requirements for each monitoring event of PCE, including
compliance with GLP Standards in accordance with 40 CFR part 792 or use
of a laboratory accredited by the AIHA (e.g., AIHA LAP, LLC Policy
Module 2A/B/E of Revision 17.3), or other analogous industry-recognized
program. Additionally, as described in Unit III.C.1., EPA is finalizing
the requirement that owners or operators must re-monitor within 15
working days after receipt of any exposure monitoring when results
indicate non-detect, unless an Environmental Professional as defined at
40 CFR 312.10 or a Certified Industrial Hygienist reviews the
monitoring results and determines re-monitoring is not necessary.
EPA is also finalizing the requirement that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
Dates, duration, and results of each sample taken.
The quantity, location(s) and manner of PCE use at the
time of each monitoring event.
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.
Name, workplace address, work shift, job classification,
work area, and type of respiratory protection (if any) of each
monitored person.
Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample.
Use of appropriate sampling and analytical methods.
Compliance with GLP Standards in accordance with 40 CFR
part 792 or use of a laboratory accredited by AIHA (e.g., AIHA LAP, LLC
Policy Module 2A/B/E of Revision 17.3), or another analogous industry-
recognized program.
Information regarding air monitoring equipment, including:
Type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
Notification of exposure monitoring results to each person
whose exposures are monitored or who is part of a monitored exposure
group.
ii. Initial Exposure Monitoring
Under the final regulation, each non-Federal owner or operator of a
facility that is engaged in one or more of the conditions of use listed
in Unit IV.B.1., except recycling and disposal, will be required to
perform initial exposure monitoring within 360 days of the publication
of this final rule or within 30 days of introduction of PCE into the
workplace, whichever is later, to determine the extent of exposure of
potentially exposed persons to PCE. As discussed in Unit III.B.1., EPA
is providing additional time for Federal agencies and Federal
contractors acting for or on behalf of the Federal government to comply
with the provisions of the WCPP, so they will be required to conduct
initial monitoring within 915 days after publication. Initial
monitoring will notify owners and operators of the magnitude of
possible exposures to potentially exposed persons with respect to their
work conditions and environments. Based on the magnitude of possible
exposures in the initial exposure monitoring, the owner or operator may
need to increase or decrease the frequency of future periodic
monitoring or adopt new exposure controls (such as engineering
controls, administrative controls, and/or a respiratory protection
program). In addition, the initial monitoring will be required when and
where the operating conditions are best representative of each
potentially exposed person's work-shift exposures. If the owner or
operator chooses to use a sample that is representative of potentially
exposed persons' full shift exposures (rather than monitor every
individual), such sampling should be representative (i.e., taken from
the breathing zone of potentially exposed persons and reflect duration
appropriate exposure) of the most highly exposed persons in the
workplace. Additionally, EPA expects that owners and operators will
conduct initial exposure monitoring representative of all tasks that a
potentially exposed person will be expected to do. EPA understands that
certain tasks may occur less frequently or may reflect accidental
exposure (for example, due to malfunction).
EPA also recognizes that some entities may already have objective
exposure monitoring data. If the owner or operator has monitoring data
conducted within five years prior to 60 days following publication of
the final rule in the Federal Register and the monitoring satisfies all
other requirements in Unit IV., 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.
Prior monitoring data cannot be used where there has been a change in
work conditions or practices that is expected to result in new or
additional exposures.
As described in more detail later in Unit IV., the owner or
operator must conduct periodic monitoring at least once every five
years since its last monitoring. This periodic monitoring must be
representative of all the potentially exposed persons in the workplace
and the tasks that they are expected to do.
iii. Periodic Exposure Monitoring
EPA is finalizing as proposed the following periodic monitoring for
owners or operators. These finalized requirements are also outlined in
table 1.
If samples taken during the initial exposure monitoring
reveal a
[[Page 103585]]
concentration below the ECEL action level (<0.10 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 must repeat the periodic exposure monitoring within three
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 (>=0.10 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 six
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 six months of
the most recent monitoring until two consecutive monitoring
measurements, taken at least seven days apart, are below the ECEL
action level (<0.10 ppm 8-hour TWA), at which time the owner or
operator must repeat the periodic exposure monitoring at least once
every five years.
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 required over the entirety of time since the last
required periodic monitoring event, EPA is requiring 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 when the
owner or operator restart any of the conditions of use listed in Unit
IV.B.1., except recycling and disposal.
Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
the ECEL action level (<0.10 ppm 8- required at least once every
hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (>0.14 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.10 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 five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.10 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 PCE in of cessation of use of PCE is
that condition of use over the required and periodic
entirety of time since the last monitoring is required when
required monitoring event. the owner or operator resumes
the condition of use.
------------------------------------------------------------------------
Table Note: Additional scenarios in which monitoring may be required are
discussed in Unit IV.B.3.b.iv.
iv. Additional Exposure Monitoring
EPA is finalizing that each owner or operator conduct additional
exposure monitoring within 30 days after 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 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, for example if an owner
or operator receives information from potentially exposed person(s)
suggesting that such new or additional exposures may have occurred. In
the event of start-up or shutdown, or spills, leaks, ruptures, or other
breakdowns or unexpected releases that may lead to exposure to
potentially exposed persons, EPA is finalizing that each owner or
operator must conduct exposure monitoring of potentially exposed
persons (using personal breathing zone sampling) within 30 days after
the conclusion of the start-up or shutdown and/or 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 six 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 three 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.
c. Regulated Area
EPA is finalizing its requirement that the owner or operator
demarcate any area where airborne concentrations of PCE exceed, or are
reasonably expected to exceed, the ECEL. To provide more clarity
regarding how regulated areas must be demarcated, EPA has incorporated
the language analogous to OSHA's regulated area requirements under the
standards for toxic and hazardous substances (29 CFR part 1910, subpart
Z) into this final rule. Owners and operators must demarcate regulated
areas from the rest of the workplace in any manner that adequately
establishes and alerts potentially exposed persons to the boundaries of
the area and minimizes the number of authorized persons exposed to PCE
within the regulated area. This can be accomplished using
administrative controls (e.g., highly visible signifiers) in multiple
languages as appropriate (e.g., whenever potentially exposed persons
who are primarily Spanish-speaking are likely to be present, owners and
operators should post additional highly visible signifiers in Spanish),
placed in conspicuous areas. The owner or operator is required to
restrict access to the regulated area from any potentially exposed
person that lacks proper training or is otherwise unauthorized to
enter.
d. Notification of Monitoring Results
EPA is finalizing the requirement that the owner or operator must,
within 15 working days after receipt of the results of any exposure
monitoring, notify each potentially exposed person whose exposure is
represented by that monitoring and their designated
[[Page 103586]]
representatives in writing, either individually to each potentially
exposed person or by posting the information in an appropriate and
accessible location, such as public spaces or common areas, for
potentially exposed persons outside of the regulated area. The notice
would be required to identify the exposure monitoring results, the ECEL
and ECEL action level and what they mean in plain language, statement
of whether the monitored airborne concentration of PCE exceeds the ECEL
and the ECEL action level, and any corresponding respiratory protection
required. If the ECEL is exceeded, the notice must also include a
description of the actions taken by the owner or operator to reduce
inhalation exposures to or below the ECEL. The notice must also include
the quantity, location, manner of PCE use, and identified releases of
PCE that could result in exposure to PCE at the time of monitoring. The
notice must 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).
4. Direct Dermal Contact Control (DDCC)
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from dermal exposures to PCE
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for PCE, EPA is finalizing largely as proposed, with
modification to the compliance timeframe as described in Unit III.B.,
the DDCC requirements for all of the conditions of use identified in
Unit IV.B.1. EPA is finalizing requirements that owners or operators
must 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) within 450 days after publication
of the final rule. For purposes of this rulemaking, 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 industrial conditions of use.
EPA has determined that preventing direct dermal contact will eliminate
the unreasonable risk of injury to health resulting from dermal
exposures for certain occupational conditions of use of PCE. See 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 in Units III.B.3. and V.A. of the 2023 PCE
proposed rule.
5. Exposure Control Plan
EPA is finalizing its requirement that owners or operators
implementing the WCPP use feasible exposure controls, including one or
a combination of elimination, substitution, engineering controls, and
administrative controls, prior to requiring the use of PPE (i.e.,
respirators or gloves) as a means of controlling exposures below EPA's
ECEL and/or prevent direct dermal contact with PCE for all potentially
exposed persons, in accordance with the hierarchy of controls (Ref.
76). If an owner or operator chooses to replace PCE with a substitute,
EPA recommends careful review of the available hazard and exposure
information on the potential substitutes to avoid a substitute chemical
that might later be found to present an unreasonable risk of injury to
health or the environment or be subject to regulation (sometimes
referred to as a ``regrettable substitution''). EPA expects that, for
conditions of use for which EPA is finalizing a WCPP, compliance at
most workplaces would be part of an established industrial hygiene
program that aligns with the hierarchy of controls.
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 is finalizing the requirement that regulated entities use the
hierarchy of controls, instituting one or a combination of controls to
the extent feasible, and supplement such protections using PPE, where
necessary, including respirators for potentially exposed persons at
risk of inhalation exposure above the ECEL and dermal PPE for persons
potentially exposed through direct dermal contact to PCE. If efforts of
elimination, substitution, engineering controls, and administrative
controls are not sufficient to reduce exposures to or below the ECEL or
prevent direct dermal contact for all potentially exposed persons in
the workplace, EPA requires that the owner or operator use feasible
controls to reduce PCE concentrations in the workplace to the lowest
levels achievable and supplement these controls with respiratory
protection and dermal PPE as needed to achieve the ECEL or prevent
direct dermal contact. In such cases, EPA requires that the owner or
operator provide potentially exposed persons reasonably likely to be
exposed to PCE by inhalation to concentrations above the ECEL with
respirators affording sufficient protection against inhalation risk and
appropriate training on the proper use of such respirators, to ensure
that their exposures do not exceed the ECEL as described in Unit IV.
EPA also requires that the owner or operator provides potentially
exposed persons reasonably likely to be exposed to PCE by direct dermal
contact with dermal protection affording sufficient protection against
dermal risk and appropriate training on the proper use of dermal
protection, as described in Unit IV. As part of the training
requirement, the owner or operator is required to provide information
and comprehensive training in an understandable manner (i.e., plain
language), considering factors such as the skills required to perform
the work activity and the existing skill level of the staff performing
the work, and in multiple languages as appropriate (e.g., based on
languages spoken by potentially exposed persons) to potentially exposed
persons. This training must be provided prior to or at the time of
initial assignment to a job involving potential exposure to PCE.
Furthermore, EPA also requires that the owner or operator document
their efforts in using elimination, substitution, engineering controls,
and administrative controls to reduce exposure to or below the ECEL in
an exposure control plan.
EPA is finalizing its requirement that the owner or operator
include and
[[Page 103587]]
document in the exposure control plan or through any existing
documentation of the facility's safety and health program developed as
part of meeting OSHA requirements or other safety and health standards,
the following:
Identification in the exposure control plan of available
exposure controls that were considered and rationale for using or not
using available exposure controls in the following sequence (i.e.,
elimination and substitution, then 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;
For each exposure control considered, exposure controls
selected based on feasibility, effectiveness, and other relevant
considerations;
A description of actions the owner or operator must take
to implement exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other steps taken;
A description of regulated areas, how they are demarcated,
and persons authorized to enter the regulated areas;
A description of activities conducted by the owner or
operator to review and update the exposure control plan to ensure
effectiveness of the exposure controls, identify any necessary updates
to the exposure controls, and confirm that all persons are properly
implementing the exposure controls; and
An explanation of the procedures for responding to any
change that may reasonably be expected to introduce additional sources
of exposure to PCE, or otherwise result in increased exposure to PCE,
including procedures for implementing corrective actions to mitigate
exposure to PCE.
Under this final rule, owners or operators are prohibited from
using rotating work schedules to comply with the ECEL 8-hour TWA, in
alignment with certain elements of existing OSHA's standards for toxic
and hazardous substances under 29 CFR part 1910, subpart Z. Owners or
operators must maintain the effectiveness of any engineering controls
and administrative controls instituted as part of the exposure control
plan. They must also review and update the exposure control plan as
necessary, but at least every five years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with the exposure control requirements. EPA intends that the exposure
control plan identify the available exposure controls and, for the
exposure controls not selected, document the efforts identifying why
these are not feasible, not effective, or otherwise not implemented.
For entities for which significant amounts of time are needed to verify
suitability of alternatives or procure funds or authorization for
additional engineering controls, for example, EPA expects that as those
controls become available the exposure control plan would be updated
accordingly. EPA requires that the exposure control plan be revisited
under certain conditions (and at least every five years) and encourages
updates as more sophisticated controls are available.
This final rule requires owners or operators to make the exposure
control plan and associated records, including ECEL exposure monitoring
records, ECEL compliance records, DDCC compliance records, and
workplace participation records, available to potentially exposed
persons and their designated representatives. Owners or operators must
notify potentially exposed persons and their designated representatives
of the availability of the exposure control plan and associated records
within 30 days of the date that the exposure control plan is completed
and at least annually thereafter. The notice of the availability of the
plan and associated records must be provided in plain language writing
to each potentially exposed person in a language that the person
understands or posted in an appropriate and accessible location outside
the regulated area with an English-language version and a non-English
version representing the language of the largest group of workers who
do not read English. This final rule also requires the owner or
operator to provide the exposure control plan and associated records at
a reasonable time, place, and manner to a potentially exposed person or
their designated representative upon request. As explained in Unit
III.C.2., if the owner or operator is unable to provide the specified
records within 15 working days, the owner or operator must inform the
potentially exposed person or designated representative requesting the
record within 15 working days that reason for the delay and the
earliest date when the record can be made available.
6. Personal Protective Equipment (PPE)
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 finalizing as
proposed with slight modifications to improve clarity or for greater
consistency with OSHA's regulations to require owners and operators to
provide PPE, including respiratory protection and dermal protection
selected in accordance with the guidelines described in this unit, and
to implement a PPE program. Unit IV. includes a description of the PPE
Program, including required PPE as it relates to respiratory
protection, required PPE as it relates to dermal protection, and other
requirements such as additional training for respirators and
recordkeeping to support implementation of a PPE program.
a. Respiratory Protection
Where elimination, substitution, engineering, and administrative
controls are not feasible or sufficiently protective to reduce the air
concentration to or below the ECEL, or if inhalation exposure above the
ECEL is still reasonably likely, EPA is finalizing, with slight
modification from the proposal, minimum respiratory PPE requirements
based on an owner or operator's most recent measured air concentration
for one or more potentially exposed persons and the level of PPE needed
to reduce exposure to or below the ECEL. In those circumstances, EPA is
finalizing requirements for a respiratory protection PPE program with
worksite-specific procedures and elements for required respirator use.
Owners or operators must develop and administer a written respiratory
protection program in accordance with OSHA's Respiratory Protection
Standard under 29 CFR 1910.134(c)(1), (c)(3), and (c)(4). EPA is
finalizing requirements that owners and operators provide training to
all persons required to use respiratory protection consistent with 29
CFR 1910.134(k) prior to or at the time of initial assignment to a job
involving potential exposure to PCE. Owners and operators must retrain
all persons required to use PPE at least 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.
EPA is finalizing requirements that each owner or operator supply a
respirator, selected in accordance with requirements described in Unit
IV., to each person who enters a regulated area within 450 days after
publication of the final rule, or within three months after the receipt
of any exposure monitoring that indicates exposures exceeding the ECEL,
and thereafter must ensure that
[[Page 103588]]
all persons within the regulated area are using the provided
respirators whenever PCE exposures exceed or can reasonably be expected
to exceed the ECEL.
EPA is also finalizing requirements that owners or operators who
are required to administer a respiratory protection PPE program must
supply a respirator selected based on a medical evaluation consistent
with the requirements of 29 CFR 1910.134(e). If a potentially exposed
person cannot use a negative-pressure respirator, then the owner or
operator must provide that person with an alternative respirator. The
alternative respirator must have less breathing resistance than the
negative-pressure respirator and provide equivalent or greater
protection. If the person is unable to use an alternative respirator,
then the person must not be permitted to enter the regulated area.
Additionally, EPA is requiring owners and operators to select
respiratory protection that properly fits each affected person and
communicate respirator selections to each affected person in accordance
with the requirements of 29 CFR 1910.134(f). Consistent with
requirements of 29 CFR 1910.134(g) through (j), EPA is requiring owners
and operators to provide, ensure use of, and maintain (in a sanitary,
reliable, and undamaged condition), respiratory protection that is of
safe design and construction. EPA is also requiring owners and
operators to provide training to all persons required to use
respiratory protection consistent with the requirements of 29 CFR
1910.134(k).
EPA is finalizing the requirements to establish minimum respiratory
protection requirements, such that any respirator affording a higher
degree of protection than the following requirements may be used. EPA
is finalizing the following requirements for respiratory protection,
based on the most recent exposure monitoring concentrations results
measured as an 8-hour TWA that exceed the ECEL (0.14 ppm):
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 1.4 ppm (10 times ECEL): Any NIOSH
Approved[supreg] air-purifying half mask respirator equipped with
organic vapor cartridges or canisters; or any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator operated in demand
mode equipped with a half mask; or any NIOSH Approved[supreg] Self-
Contained Breathing Apparatus (SCBA) in a demand mode equipped with a
half mask [Assigned Protection Factor (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
Approved[supreg] Powered Air-Purifying Respirator (PAPR) equipped with
a loose-fitting facepiece or hood/helmet equipped with organic vapor
cartridges or canisters; or any NIOSH Approved[supreg] SAR or Airline
Respirator in a continuous-flow mode equipped with a loose-fitting
facepiece or helmet/hood [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
Approved[supreg] air-purifying full facepiece respirator equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg] PAPR
with a half mask equipped with organic vapor cartridges or canisters;
any NIOSH Approved[supreg] SAR or Airline Respirator in a continuous
flow mode equipped with a half mask; any NIOSH Approved[supreg] SAR or
Airline Respirator operated in a pressure-demand or other positive-
pressure mode with a half mask; or any NIOSH Approved[supreg] SCBA in
demand-mode equipped with a full facepiece or helmet/hood [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
Approved[supreg] PAPR equipped with a full facepiece equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg] SAR
or Airline Respirator in a continuous-flow mode equipped with full
facepiece; any NIOSH Approved[supreg] SAR or Airline Respirator in
pressure-demand or other positive-pressure mode equipped with a full
facepiece and an auxiliary self-contained air supply; or any NIOSH
Approved[supreg] SAR or Airline Respirator in a continuous-flow mode
equipped with a helmet/hood and has been tested to demonstrate
performance at a level of a protection of APF 1,000 or greater. [APF
1,000].
If the measured exposure concentration is greater than 140
ppm (1,000+ times ECEL): Any SCBA in a pressure-demand or other
positive-pressure mode equipped with a full facepiece or helmet/hood
[APF 10,000].
If the exposure concentration is unknown: Any NIOSH
Approved[supreg] combination supplied air respirator equipped with a
full facepiece and operated in pressure demand or other positive
pressure mode with an auxiliary self-contained air supply; or any NIOSH
Approved[supreg] SCBA operated in pressure demand or other positive
pressure mode and equipped with a full facepiece or helmet/hood [APF
1000+].
Additionally, EPA is finalizing requirements that owners or
operators select and provide respirators in accordance with the
requirements of 29 CFR 1910.134(d)(1)(iv) and with consideration of
workplace and user factors that affect respirator performance and
reliability.
EPA is requiring 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. Consistent with 29 CFR
1910.134(d)(3)(iii), EPA is requiring 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 also requiring owners and
operators to ensure that respirators are used in compliance with the
terms of the respirator's NIOSH certification.
EPA is finalizing requirements that owners and operators must
conduct regular evaluations of the workplace, including consultations
with potentially exposed persons using respiratory protection,
consistent with the requirements of 29 CFR 1910.134(l), to ensure that
the provisions of the written respiratory protection program described
in this Unit are being effectively implemented.
EPA is finalizing the requirement that owners and operators
document respiratory protection used and PPE program implementation.
EPA is finalizing requirements that owners and operators document in
the exposure control plan or other documentation of the facility's
safety and health program information relevant to the 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, fit-testing, and training
as described in this unit.
b. Dermal Protection
As described in Unit III.B.1., EPA is finalizing requirements that
each owner or operator supply dermal PPE that separates and provides a
barrier to prevent direct dermal contact with PCE, selected in
accordance with requirements described in this Unit, to each person who
is reasonably likely to be dermally exposed in the work area through
direct dermal contact, to be effective within 450 days of the
publication of this final rule. Where elimination, substitution,
engineering
[[Page 103589]]
controls, and administrative controls are not feasible or sufficient to
fully prevent direct dermal contact with PCE, EPA is finalizing
requirements that appropriate dermal PPE be provided by owners and
operators to, and be worn by, persons potentially exposed to direct
dermal contact with PCE. EPA is requiring owners and operators to
provide dermal PPE that is of safe design and construction for the work
to be performed. EPA is also requiring owners and operators ensure each
potentially exposed person who is required to wear PPE to use and
maintain PPE in a sanitary, reliable, and undamaged condition.
Additionally, EPA is requiring owners and operators to select and
provide PPE that properly fits each potentially exposed person who is
required to use PPE and communicate PPE selections to each affected
person.
In choosing appropriate dermal PPE, EPA is requiring owners and
operators 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 or individually
prepared third party testing 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 times. EPA is also requiring that owners and operators
demonstrate 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. In
alignment with the OSHA Hand Protection PPE Standard (29 CFR 1910.138),
EPA is requiring owners and operators 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. EPA is also requiring owners and operators 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. Further information
related to choosing appropriate PPE can be found in the summary of
suitable gloves for PCE memo (Ref. 67).
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 finalizing as proposed 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 impervious during expected durations of use and conditions of
exposure. EPA is finalizing requirements 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. 77). EPA is also finalizing requirements that
replacement PPE must be provided immediately 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 finalizing as proposed requirements 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.
Additionally, as part of the PPE program, EPA is also finalizing as
proposed 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 dermal
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 finalizing that owners and operators provide PPE training to all
persons required to use dermal PPE prior to or at the time of initial
assignment to a job involving potential exposure to PCE. Owners and
operators 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.
EPA is also finalizing as proposed requirements that owners and
operators retain records of dermal PPE used and program implementation.
EPA is requiring 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:
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
be present and the type of PPE selected to be worn by each of these
persons;
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);
Appropriately sized PPE and training on proper
application, wear, and removal of PPE, and proper care/disposal of PPE;
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
Training described in this unit.
7. Additional Finalized Requirements
a. Workplace Information and Training
EPA is also finalizing its requirements to implement a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with PCE
exposure, EPA is finalizing as proposed with slight modification 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 within 450 days after publication of the final rule. For
purposes of workplace information and training, owners and operators
are only required to train potentially exposed persons that are
expected to be present in the workplace or to directly handle PCE or
handle equipment or materials on which PCE may be present.
[[Page 103590]]
As part of the training and information program, the owner or
operator is required to provide information and comprehensive training
in an understandable manner (i.e., plain language) and in multiple
languages 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. Owners and operators are required to provide information and
training, as referenced in the OSHA Hazard Communication Standard, to
all potentially exposed persons that includes:
The requirements of the PCE WCPP and how to access or
obtain a copy of the requirements of the WCPP, including but not
limited to the exposure control plan, monitoring requirements, and PPE
program;
The quantity, location, manner of use, release, and
storage of PCE and the specific operations in the workplace that could
results in PCE exposure, particularly noting where each regulated area
is located;
Principles of safe use and handling of PCE in the
workplace, including specific measures the owner or operator has
implemented to reduce inhalation exposure at or below the ECEL or
prevent dermal contact with PCE, such as work practices and PPE used;
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
The acute and chronic health hazards of PCE as detailed on
relevant Safety Data Sheets (SDSs).
In addition to providing training at the time of initial assignment
to a job involving potential exposure to PCE, owners and operators
subject to the PCE WCPP are 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. EPA is finalizing its
requirements that owners and 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 finalizing as proposed 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.
b. Workplace Participation
EPA encourages owners and operators to consult with potentially
exposed persons and their designated representatives on the development
and implementation of exposure control plans and PPE/respirator
programs. EPA is finalizing the requirement that owners and operators
provide potentially exposed persons and their designated
representatives regular access to the exposure control plans, exposure
monitoring records, and PPE program implementation. To ensure
compliance with workplace participation, EPA is finalizing its
requirement that the owner or operator document the notice to and
ability of any potentially exposed person that may reasonably be
affected by PCE exposure 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.
c. Recordkeeping
For owners and operators to demonstrate compliance with the WCPP
provisions, EPA is requiring that owners and operators must retain
compliance records for five years (although this requirement does not
supplant any longer recordkeeping retention time periods such as those
required under 29 CFR 1910. 1020 or other applicable regulations). EPA
is requiring the owner or operator to retain records of:
Exposure control plan;
PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
Information and training provided to each person prior to
or at the time of initial assignment and any retraining.
In addition, EPA is finalizing as proposed requirements that owners
and operators subject to the WCPP ECEL requirements maintain records to
include:
Regulated areas and authorized personnel;
The exposure monitoring records;
Notification of exposure monitoring results; and
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, are required to make
all records that are maintained as described in Unit IV. available to
EPA for examination and copying in accordance with EPA requirements.
EPA emphasizes that all records required to be maintained can be kept
in the most administratively convenient form such as electronic record
form or paper form.
8. Compliance Timeframes
With regard to the compliance timeframe for those occupational
conditions of use which are subject to the WCPP, EPA is not finalizing
the timeframes proposed. Rather, as discussed in Unit III.B.1, based on
consideration of public comments and reasonably available information,
EPA is finalizing longer timeframes for non-Federal owners or
operators, and is providing Federal agencies and Federal contractors
acting for or on behalf of the Federal government additional time to
comply with each of the provisions of the WCPP. Specifically, EPA is
finalizing its requirement that non-Federal owners and operators
perform initial exposure monitoring according to the process outlined
in Unit IV. within 360 days after publication of the final rule in the
Federal Register, or within 30 days of introduction of PCE into the
workplace, whichever is later. Federal agencies and Federal contractors
acting for or on behalf of the Federal government must conduct initial
exposure monitoring within 915 days after the date of publication, or
within 30 days of introduction of PCE into the workplace, whichever is
later. EPA is also finalizing its requirement that each non-Federal
owner or operator ensure that exposure to PCE does not exceed the ECEL
as an 8-hour TWA for all potentially exposed persons within 450 days
after publication of the final rule, while Federal agencies and Federal
contractors acting for or on behalf of the Federal government must
comply with the ECEL within 1005 days after the date of publication. If
applicable, each owner or operator must provide respiratory protection
sufficient to reduce inhalation exposures to below the ECEL to all
potentially exposed persons in the regulated area within three months
after receipt of the results of any exposure monitoring that indicates
an exceedance of the ECEL. For non-Federal owners or operators, this
will be within 450 days after publication of the final rule in the
Federal Register. For Federal agencies and Federal contractors acting
for or on behalf of the Federal government, this will be within 1005
after the date publication. EPA is also finalizing the requirement that
owners and operators demarcate a regulated area within three months
after receipt of any exposure
[[Page 103591]]
monitoring that indicates exposures exceeding the ECEL. Additionally,
EPA is finalizing requirements that each non-Federal owner or operator
ensure all persons are separated, distanced, physically removed, or
isolated from direct dermal contact with PCE, including by providing
dermal PPE within 450 days after publication of the final rule, while
Federal agencies and Federal contractors acting for or on behalf of the
Federal government must comply with dermal controls no later than 1005
days after publication of the final rule. Non-Federal owners or and
operators shall proceed accordingly to implement an exposure control
plan, including institution of feasible exposure controls other than
PPE, within 900 days of the publication of this final rule, while
Federal agencies and Federal contractors acting for or on behalf of the
Federal government must implement an exposure control plan within 1095
days after the date of publication.
C. Prescriptive Controls
In contrast to the non-prescriptive requirements of the WCPP,
including DDCC, where regulated entities would have flexibility to
select controls in accordance with the hierarchy of controls to comply
with the parameters outlined in Unit IV.B., EPA has found it
appropriate in certain circumstances to require specific prescriptive
controls for certain occupational conditions of use. In general, EPA is
finalizing the prescriptive controls as proposed, with some
modifications, for the industrial and commercial use of PCE as a
laboratory chemical, as described in Unit III.A.2.d. Additionally, EPA
is finalizing prescriptive controls for the industrial and commercial
use in energized electrical cleaning. The rationale for these changes
from the 2023 PCE proposed rule, after consideration of public
comments, is in Unit III.A.2.e. This unit provides a description of the
conditions of use subject to specific prescriptive controls, the
specific prescriptive control requirements, and the compliance
timeframes for the requirements.
1. Workplace Requirements for Laboratory Use
a. Applicability
The industrial and commercial use of PCE as a laboratory chemical
refers to the industrial or 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, such as use as a solvent,
reagent, analytical standard, or other experimental use.
EPA recognizes that potentially exposed persons in a laboratory
setting may include students, researchers, visiting scholars, or others
whose job classifications may vary, such as depending on the academic
period in university laboratories. The requirements described in Unit
IV. apply to all potentially exposed persons in all laboratory
settings, including academic and research laboratories, regardless of
job classification.
b. Workplace Requirements
To 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 requiring dermal PPE, including
impermeable gloves and protective clothing, 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 with direct dermal contact to PCE in the work area
through direct handling of the substance or from contact with surfaces
that may be contaminated with PCE. For dermal PPE, EPA is requiring
that each owner or operator comply with the requirements outlined in
Units IV.B.6.b. for selection of dermal PPE and training for all
potentially exposed persons. EPA's description for how the requirements
for the industrial and commercial use as a laboratory chemical address
the unreasonable risk resulting from dermal exposures under the
conditions of use and the rationale for this regulatory approach is
outlined in Unit V. of the 2023 PCE proposed rule.
In addition, EPA is requiring the use of laboratory ventilation
devices, such as fume hoods, glove boxes, air handling units, exhaust
fans, biological safety devices, airflow controls, and other local
exhaust devices, in workplace laboratory settings for the industrial
and commercial use of PCE as a laboratory chemical, to codify existing
good laboratory practices. EPA is requiring each owner or operator of a
workplace laboratory setting, to ensure laboratory ventilation devices
are in use and functioning properly to minimize exposures to 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, for
National Research Council recommendations concerning laboratory
chemical hood ventilation system characteristics and practices and to
ANSI's and ASSP's Z9.5-2022 for recommendations on additional
laboratory ventilation controls to minimize exposures to potentially
exposed persons in the work area.
c. Recordkeeping
To support and demonstrate compliance, EPA is requiring that each
owner or operator of a laboratory workplace subject to the requirements
of this unit retain compliance records for five years. In alignment
with 29 CFR 1910.1450(e)(3)(ii) and (iii) and 29 CFR 1910.132(d)(2),
EPA is requiring that owners and operators must retain records of:
Dermal protection used by each potentially exposed person
and PPE program implementation as outlined in this unit;
Criteria that the owner or operator will use to determine
and implement control measures to reduce potentially exposed persons'
exposure to PCE including laboratory ventilation devices as outlined in
this unit; and
Implementation of properly functioning laboratory
ventilation devices using manufacturer's instructions for installation,
use, and maintenance of the systems, 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 must re-assess and update
these records.
d. Compliance Timeframes
With regards to the compliance timeframe, EPA is requiring that
each owner or operator of a workplace engaged in the industrial and
commercial of PCE as a laboratory chemical ensure laboratory
ventilation devices are in use and functioning properly and that dermal
PPE is provided to all potentially exposed persons with direct dermal
contact with PCE within 360 days after publication of the final rule.
2. Workplace Requirements for Energized Electrical Cleaner
To address the unreasonable risk of injury to health resulting from
inhalation and dermal exposures to PCE identified for the industrial
and commercial use as an energized electrical cleaner, which is a sub-
use of the industrial and commercial use as an aerosol spray degreaser/
cleaner, and in consideration of the lack of reasonably available
technically and economically
[[Page 103592]]
feasible alternatives to PCE for energized electrical cleaning, EPA is
requiring (i) specific prescriptive controls outlined in this Unit,
including dermal PPE and respiratory protection, or (ii) implementation
of the WCPP outlined in Unit IV.B. EPA is also requiring labels and
self-certification. As described in Unit III.A.2.e., EPA's workplace
requirements to address the unreasonable risk for industrial and
commercial use as an energized electrical cleaner are consistent to the
extent possible with existing regulations and best practices for work
in electrical spaces. EPA acknowledges the existing OSHA requirements
for electrical protective equipment under 29 CFR 1910.137 and does not
believe the requirements in this rule interfere with a potentially
exposed person's ability to safely use electrical protective equipment,
such as rubber insulating gloves and rubber insulating sleeves, as
required under OSHA.
a. Applicability
The industrial and commercial use of PCE as an energized electrical
cleaner refers to the use of PCE in a product that meets both of the
following criteria: (1) the product is labeled to clean and/or degrease
electrical equipment, where cleaning and/or degreasing is accomplished
when electrical current exists, or when there is a residual electrical
potential from a component, such as a capacitor; and; (2) the product
label clearly displays the statements: ``Energized Equipment use only.
Not to be used for motorized vehicle maintenance, or their parts.''
b. Workplace Requirements for Energized Electrical Cleaner
EPA is requiring that owners or operators must either implement (i)
specific prescriptive controls that provide dermal PPE and respiratory
protection, or (ii) implement the WCPP for industrial and commercial
use as energized electrical cleaner. Owners and operators must maintain
a statement regarding whether the business is complying with the
specified prescriptive controls or with the WCPP.
i. Prescriptive Controls
A. Dermal protection. To address the unreasonable risk of injury to
health resulting from dermal exposures to PCE identified for the
industrial and commercial use as an energized electrical cleaner, EPA
is requiring dermal PPE, including impermeable gloves and protective
clothing, in combination with comprehensive training for each
potentially exposed person with direct dermal contact to PCE in the
work area through direct handling of the substance or from contact with
surfaces that may be contaminated with PCE. For dermal PPE, EPA is
requiring that each owner or operator comply with the requirements
outlined in Unit IV.B.6.b. for selection of dermal PPE and training for
all potentially exposed persons.
B. Respiratory protection. Based on the 2020 Risk Evaluation for
PCE, EPA determined that the use of respirators with an APF of 50 could
control PCE air concentrations to levels that address the unreasonable
risk from inhalation exposure based on high-end exposures for the
industrial and commercial use in aerosol spray degreaser/cleaner.
Therefore, EPA is requiring use of specific respiratory protection, in
combination with comprehensive training, for use of an energized
electrical cleaner containing PCE in confined spaces, as defined in 29
CFR 1910.146(b), or in an enclosed space (such as a manhole or vault),
as described in 29 CFR 1910.269(c). Specifically, EPA is requiring
owners or operators to provide to potentially exposed persons, and
potentially exposed persons to use, the following: any NIOSH
Approved[supreg] air-purifying full facepiece respirator equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg]
Powered Air-Purifying Respirator (PAPR) with a half mask equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator in a continuous
flow mode equipped with a half mask; any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or
any NIOSH Approved[supreg] SCBA in demand-mode equipped with a full
facepiece or helmet/hood [APF 50]; or any respirator affording a higher
degree of protection. In providing the specified respirators and
training to potentially exposed persons, EPA is requiring owners or
operators to administer a PPE program with procedures and elements for
required respirator use as outlined in Unit IV.B.6.a. for proper
respirator use, maintenance, fit-testing, medical evaluation, and
training. EPA is requiring 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.
For energized electrical cleaning in spaces that are not enclosed
or confined, EPA is requiring use of respiratory protection described
in Unit IV. if the potentially exposed person is permitted to approach
exposed energized parts closer than the employer's established minimum
approach distance by meeting the requirements of 29 CFR
1910.269(l)(3)(iii)(A) through (C) or 29 CFR 1910.333(c)(3)(ii)(A)
through (C), or if there is no established minimum approach distance.
ii. WCPP
EPA understands that there may be instances where a performance-
based standard is more appropriate to address the unreasonable risk for
the industrial and commercial use of PCE as an energized electrical
cleaner, instead of the specific prescriptive dermal and respiratory
protection requirements described in Unit IV.C.2.b.i. For example, the
WCPP may be preferred by owners or operators that regularly use PCE to
clean energized electrical equipment onsite at their facility or by
owners or operators that are implementing the WCPP at their facility
for another condition of use of PCE. In these instances, EPA is
requiring owners or operators to comply with the WCPP requirements,
including the ECEL, direct dermal contact controls, and ancillary
provisions, outlined in Univ IV.B. Owners and operators who choose to
follow the WCPP as an alternative to the specific prescriptive controls
must also document and maintain a statement that they are electing to
comply with the WCPP.
c. Labeling Requirements for Energized Electrical Cleaner
To prevent the use of an energized electrical cleaner containing
PCE for unintended applications, such as automotive maintenance or
electrical cleaner, EPA is requiring that all manufacturers (including
importers), processors, and distributors in commerce of energized
electrical cleaner containing PCE provide a label securely attached to
each product. Label information is required to be clearly displayed in
an easily readable font size, and containing the following text: ``This
product contains perchloroethylene (PCE) (CASRN 127-18-4), a chemical
determined by the Environmental Protection Agency to present
unreasonable risk of injury to health under the Toxic Substances
Control Act (TSCA), based on neurotoxicity and other adverse health
effects. The use of PCE is restricted under 40 CFR part 751, subpart G.
This product is for Energized Equipment use only. Not to be used for
motorized vehicle maintenance, or their parts.''
[[Page 103593]]
d. Self-Certification for Energized Electrical Cleaner
To ensure safe and appropriate use of PCE as an energized electric
cleaner and to prevent use of an energized electrical cleaner
containing PCE for unintended applications, EPA is requiring a point-
of-sale self-certification requirement in order to purchase and
subsequently use PCE as an energized electrical cleaner. Under this
self-certification requirement, EPA is requiring owners or operators,
or persons specifically authorized by the owner or operator to purchase
energized electrical cleaner, to submit a self-certification to the
distributor each time energized electrical cleaner containing PCE is
purchased. The self-certification consists of a statement indicating
the owner or operator is implementing the prescriptive controls
described in Unit IV. or the WCPP described in Unit IV.B. at their
business. The self-certification must be signed and presented by a
person authorized to do so by the owner or operator of the business
entity. EPA is requiring that copies of the self-certification be
maintained as records by both the owner or operator and the distributor
where PCE was purchased.
Owners or operators who wish to continue or begin purchasing
energized electrical cleaners containing PCE must self-certify that the
business is implementing and complying with all aspects of the
workplace controls (specified respiratory and dermal PPE or the WCPP)
described in Unit IV., with the self-certification statement set forth
in 40 CFR 751.611(d)(1). This self-certification statement includes,
among other information, that the business entity has complied with the
rule's requirements and understands the significant penalties for
noncompliance with these requirements.
The self-certification statement must be signed and dated by the
owner or operator, including a name, title, email address, and phone
number for the owner or operator who is self-certifying. The self-
certification statement must also list the name and address of the
business entity that is being certified and indicate if this is the
business entity's first purchase of energized electrical cleaner
containing PCE, after publication of the final rule. The self-
certification statement would be valid for one year, unless the
business entity has changed processes or there is an indication that
exposures to PCE have changed.
To ensure distributors are only selling PCE to owners or operators,
or to persons specifically authorized by the owner or operator to
purchase energized electrical cleaners, of business entities able to
implement and comply with the workplace requirements for energized
electrical cleaner, EPA is requiring owners or operators who self-
certify to provide a copy of the business entity's current self-
certification statement to the distributor from whom energized
electrical cleaner containing PCE is being purchased, for every
purchase of PCE. EPA is also requiring the distributors to collect,
maintain, and retain a copy of the self-certification statement. EPA is
also requiring distributors to keep records, such as invoices, that
indicate the name of the purchaser and business entity, date of sale,
and quantity of PCE purchased. Distributors of PCE as an energized
electrical cleaner may only distribute to those companies that provide
the correct self-certification statement for purchasing. EPA realizes
that some companies may not engage in or use energized electrical
cleaners containing PCE at the time this rule is finalized. Owners or
operators that may wish to purchase energized electrical cleaners
containing PCE after the publication of the final rule are required to
submit the self-certification statement to the distributor from whom
PCE was initially purchased in order to purchase PCE, certifying that
the business for which PCE is being purchased will implement and comply
with the workplace requirements for industrial and commercial use as an
energized electrical cleaner. EPA is also requiring that sellers and
distributors review the self-certification statement to ensure it is
appropriately completed to include the business entity's information,
as outlined in Unit IV. Distributors of PCE for use in energized
electrical cleaners must have a complete and valid self-certification
statement in accordance with this section for each sale of PCE for such
use. EPA is requiring that the distributors and owners or operators
maintain and retain the self-certification statement and related
invoices in the most administratively convenient form (electronic or
paper) and retain the statement and supporting documentation for five
years.
e. Recordkeeping
To support and demonstrate compliance, EPA is requiring that each
owner or operator subject to the requirements of this Unit retain
compliance records for five years. EPA is requiring that owners and
operators must retain records of:
The self-certification statement and related invoices,
including: (A) the written statement required in Unit IV.C.2.d.; (B)
printed name and signature, job classification, email address, and
phone number of the owner or operator who is self-certifying; (C) date
of self-certification; and (D) name and address of business entity; and
Statement regarding whether the owner or operator is
complying with the prescriptive dermal and respiratory protection
requirements or with the WCPP.
Additionally, for owners or operators that elect to comply with the
prescriptive dermal and respiratory protection requirements outlined in
Unit IV.C.2.b.i., EPA is requiring that owners and operators must
retain records of:
Dermal protection used by each potentially exposed person
and program implementation;
Respiratory protection used by each potentially exposed
person and program implementation;
For owners or operators that elect to comply with the WCPP instead
of the prescriptive dermal and respiratory protection outlined in Unit
IV.C.2.b.i., owners and operators must retain the records described in
Unit IV.B.7.c.
EPA is also requiring sellers and distributors of energized
electrical cleaner containing PCE to retain the following:
Invoices that include: (A) name of purchaser; (B) date of
sale; and (C) quantity of PCE or PCE containing products sold; and
Self-certification statement for each purchase of PCE; and
Copies of the labels required in Unit IV.C.2.c.
f. Compliance Timeframes
With regards to the compliance timeframe, EPA is requiring that
each owner or operator of a business entity engaged in the industrial
and commercial use of PCE as an energized electrical cleaner either:
(1) Implement the specific prescriptive controls of dermal and
respiratory protection for energized electrical cleaner described in
this unit within 450 days of the publication of this final rule or (2)
implement the WCPP in accordance with the compliance timeframes
described in Unit IV.B.8., which includes requiring owners and
operators to establish initial monitoring within 360 days of the
publication of this final rule and providing PPE within 450 days of the
publication of this final rule. Additionally, EPA is requiring that the
labeling requirement take effect 450 days after publication of this
final rule for manufacturers (including importers), processors, and
distributors of energized electrical cleaner containing PCE. EPA
[[Page 103594]]
is also requiring the self-certification requirements take effect 450
days after publication of this final rule for owners or operators and
distributors.
D. Prohibition of Manufacture, Processing, Distribution, and Use of PCE
1. Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution in Commerce of PCE for
Those Uses
In general, EPA is finalizing the prohibitions as proposed, with
some modifications, including for compliance timeframes to provide for
reasonable transitions, based on consideration of the public comments.
The rule prohibits the manufacture, processing, distribution in
commerce, and use of PCE for all industrial and commercial use, except
for those industrial and commercial uses which would continue under the
WCPP (as identified in Unit IV.A.2.), laboratory use (as identified in
Unit IV.A.3.) and use as an energized electrical cleaner (as identified
in Unit IV.A.3). Based on comments, EPA is finalizing timeframes longer
than proposed for prohibitions of manufacture, processing,
distribution, and most industrial and commercial use of PCE broadly.
The rationale for these changes from the 2023 PCE proposed rule is in
Unit III.B.2. EPA is also finalizing as proposed the phaseout
timeframes for the industrial and commercial use of PCE in dry cleaning
and related spot cleaning as described in Unit IV.D.3.
As discussed in Unit II.C.4., the prohibitions do not apply to any
substance that is excluded from the definition of ``chemical
substance'' under TSCA section 3(2)(B)(ii) through (vi) (Ref. 8).
The final regulation will impose prohibitions in a staggered
timeframe, beginning at the top of the supply chain, as proposed. As
discussed in Unit III.B.2., in response to comments received, EPA is
finalizing timeframes for prohibitions according to the following
staggered timeframe:
Within 540 days of publication of this final rule for
prohibitions on manufacturers;
Within 630 days of publication of this final rule for
prohibitions on processors;
Within 720 days of publication of this final rule for
prohibitions on distributing to retailers;
Within 810 days of publication of this final rule for
prohibitions on all other distributors (including retailers); and
Within 900 days of publication of this final rule for
prohibitions on industrial and commercial users.
Additionally, EPA had proposed a WCPP for the industrial and
commercial use of PCE for in-line conveyorized and web vapor
degreasing. After receiving public comments that clarified that these
uses are no longer ongoing, EPA is finalizing the prohibition of these
uses.
2. Prohibition of Manufacturing, Processing and Distribution in
Commerce of PCE for Consumer Use
The final rule prohibits the manufacture, processing, and
distribution in commerce of PCE and PCE-containing products for all
consumer use. As discussed in the 2023 PCE proposed rule and in this
final rule, ``consumer use'' refers to all known, intended, or
reasonably foreseen PCE consumer uses.
EPA is also finalizing the proposed prohibitions on distributing in
commerce to retailers, and on retailers from distributing in commerce,
PCE and all PCE-containing products for any use (with the exception of
dry cleaning, which is subject to a separate phaseout described in Unit
IV.D.3), in order to prevent products intended for industrial and
commercial use under the WCPP or prescriptive controls from being
purchased by consumers. The prohibitions described in this unit will
take effect in the following timeframes:
Within 540 days of publication of this final rule for
prohibitions on manufacturers;
Within 630 days of publication of this final rule for
prohibitions on processors, within 720 days of publication of this
final rule for prohibitions on distributing to retailers; and
Within 810 days of publication of this final rule for
prohibitions on all other distributors (including retailers).
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 (40 CFR 751.5). For a distributor not
to be considered a retailer, the distributor must distribute or make
available products 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 prevents retailers from making these
products available to consumers, which helps address that part of the
unreasonable risk from PCE contributed by consumer use.
3. Prohibition and Phaseout of PCE in Dry Cleaning
EPA is finalizing as proposed the prohibition on the manufacturing,
processing, distribution of 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. A prohibition on the
manufacturing, processing, distribution in commerce, and industrial and
commercial use of PCE in dry cleaning and spot cleaning addresses the
unreasonable risk for the following conditions of use as described in
Unit III.B.1 of the 2023 PCE proposed rule:
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.
Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th generation 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.
Consumer use in dry cleaning solvent (i.e., exposure to
clothing or articles recently dry cleaned with PCE). This condition of
use refers to consumer
[[Page 103595]]
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.
EPA is finalizing a phaseout period following the publication of
the final rule. The phaseout starts with a prohibition on the
industrial or commercial use of PCE in any dry cleaning machine
acquired 180 days or later after publication of the final rule,
followed by a prohibition on the industrial or commercial use of PCE in
3rd generation machines 3 years after publication of the final rule.
Full implementation of the phaseout will be achieved with a prohibition
on the industrial or commercial use of PCE in all dry cleaning and spot
cleaning, including in 4th and 5th generation machines, 10 years after
publication 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 publication of the final rule. 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 United States
market (Ref. 21). 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. 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. EPA
believes that the 180-day and 3-year compliance dates for the start of
the phaseout, and the 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 five 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).
E. Other Requirements
1. Recordkeeping
For conditions of use that are not otherwise prohibited under this
final rule, EPA is finalizing as proposed the requirement 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. This
requirement begins 60 days following publication of the final rule in
the Federal Register. For enforcement purposes, EPA will have access to
such businesses records plus additional records required under 40 CFR
751.615. Recordkeeping requirements would ensure that owners or
operators can demonstrate compliance with the regulations if necessary.
2. Downstream Notification
For conditions of use that are not otherwise prohibited or are
subject to delayed prohibition compliance timeframes under this final
regulation, EPA is finalizing as proposed, with slight modification,
the requirements that manufacturers (including importers), processors,
and distributors, excluding retailers, of PCE and PCE-containing
products provide downstream notification of the prohibitions through
the SDSs by adding to sections 1(c) and 15 of the SDS the language set
forth in 40 CFR 751.613(c). This notification spreads awareness
throughout the supply chain that PCE and PCE-containing products can
only be distributed in commerce or processed with a concentration of
PCE equal to or greater than 0.1% by weight for uses that are not
prohibited and for dry cleaning until the prohibition dates come into
effect.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA's final rule
requires manufacturers to revise their SDS within two months of rule
publication and processors and distributors to revise their SDS within
six months of rule publication. EPA did not receive public comments
asserting that these compliance dates for updating the SDS were
impracticable, and is therefore finalizing the compliance dates as
proposed. The intention of downstream notification is to spread
awareness throughout the supply chain of the restrictions on PCE under
TSCA and to provide information to commercial end-users about allowable
uses of PCE.
F. TSCA Section 6(g) Exemptions
EPA is finalizing with minor clarifications the proposed 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; and Industrial and commercial use in wipe
cleaning. The exemption includes conditions, pursuant to TSCA section
6(g)(4), including required notification and controls for exposure, to
the extent feasible. Specifically, this regulation requires the
following: (1) NASA and its contractors must provide notice to the EPA
Assistant Administrators of both the Office of Enforcement and
Compliance Assurance and the Office of Chemical Safety and Pollution
Prevention of each instance of emergency use within 15 days; and (2)
NASA and its contractors must comply with the WCPP described in Unit
IV.B to the extent feasible. The notification must 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 finalized, 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 safer alternatives. EPA notes that in the event
that sensitive information clearly marked as such relating to national
security or critical infrastructure is submitted to EPA at any point
during the TSCA section 6 process, the Agency will protect such
information in accordance with applicable authorities.
EPA expects NASA and its contractors have the ability to implement
a WCPP as described in Unit IV.B. for the identified uses in the
context of an emergency, to some extent even if not to the full extent
of WCPP implementation. Therefore, NASA must comply with the WCPP to
the extent technically feasible in light of the particular emergency.
NASA and its contractors would still be subject to the general
recordkeeping requirements discussed in Unit IV.E.1.
[[Page 103596]]
V. 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 and the
2022 revised unreasonable risk determination for PCE (Refs. 1, 2). A
summary is presented in Unit V.
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. Prenatal and early childhood
exposure to PCE has also been linked to statistically significant
increased risk of engaging in risky behaviors. 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. 78), 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 259,609 workers
and 31,449 occupational non-users (ONUs) (Ref. 3). The number of
consumers that use the approximately 115 types of products containing
PCE each year is unknown. See section 6.1.9 of the Economic Analysis
and section 8.4.1 of the response to comment document for additional
detail, including a description of changes made from the 2023 PCE
proposed rule to EPA's estimates in response to public comment (Refs.
3, 8).
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 these estimates of numbers of workers, occupational
non-users, 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. (While bystanders are individuals in
proximity to a consumer use of PCE, fenceline communities are a subset
of the general population who may be living in proximity to a facility
where PCE is being used in an occupational setting). EPA separately
conducted a screening approach to assess whether there may be potential
risks to the general population from these exposure pathways. This
analysis is summarized in full in the 2023 PCE proposed rule, which
includes information on the SACC peer review. This unit addresses those
areas where some risk was indicated at the fenceline, and the condition
of use will be continuing under the rule.
EPA's analysis methodology was presented to the SACC peer review
panel in March 2022, and EPA is including SACC recommendations, as
appropriate, in assessing general population exposures in upcoming risk
evaluations. 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. 79). EPA therefore
does not intend to revisit or conduct an analysis of the water pathway
for PCE as part of a supplemental risk evaluation.
EPA's analysis for the air pathway for PCE using methodology
presented to SACC and the multi-year analysis conducted in response
indicated potential exposure and associated risks to select populations
within the general population at particular facilities (Ref. 80). As
described in Unit VI.A. of the 2023 PCE proposed rule, 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.
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 screening analysis
whether those risks drive the unreasonable risk of injury to health
presented by PCE. Although EPA did not make a determination of
unreasonable risk based on the fenceline screening analysis, this final
regulatory action is expected to reduce the risks identified in the
screening approach. Additionally, while the fenceline screening
analysis identified facilities with some indication of releases and
potential exposures with associated increased cancer risk that exceeds
the 1 x 10-6 benchmark, the analysis did not identify any
facilities exceeding the 1 x 10-4 benchmark; the highest
risk estimate identified is in the 1 x 10-5 range (Ref. 80).
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). For example, when setting standards under CAA section
112(f)(2), EPA uses a two-step process, with ``an analytical first step
to determine an `acceptable risk' that considers all health
information, including risk estimation uncertainty, and includes a
presumptive limit on maximum individual risk (MIR) of approximately 1-
in-10 thousand'' (Ref. 81, referencing the interpretation set forth in
the 1989 final National Emission Standards for Benzene rule (54 FR
38044 Sept. 14, 1989)).
EPA believes that the prohibitions being finalized for
manufacturing (including importing), processing, and distribution in
commerce for all consumer use and most commercial use would reduce
exposures to the general population, including fenceline communities.
Of the 29 facilities which indicated potential exposure and associated
increased cancer risk to fenceline communities, under the final
regulation, 20 may be associated with conditions of use that EPA is not
prohibiting, and thus exposures at the fenceline at the remaining 9
facilities would be addressed.
Under the final rule, only 16 conditions of use will continue (see
[[Page 103597]]
Units IV.B. and IV.C. for a summary). For many of these conditions of
use, EPA expects use and associated production volume of PCE to decline
over time. For example, the manufacturing and processing: incorporation
into a formulation, mixture, or reaction product conditions of use can
reasonably be expected to decline. While EPA is permitting the
continued manufacturing and processing of PCE subject to the WCPP, the
downstream distribution and use of formulations, mixtures, or reaction
products for most conditions of use would be prohibited. Exceptions
include the distribution and use of products for conditions of use that
EPA is not prohibiting in this final regulation, including certain
degreasing applications (e.g., vapor degreasing, cold cleaning, and
energized electrical cleaning), chemical milling, adhesives and
sealants, processing aid, and laboratory use. Additionally, EPA expects
the processing 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. HFC-125 and HFC-134a are two of the regulated substances
that are subject to the AIM Act phasedown.
For the conditions of use that are not prohibited, this final rule
requires exposure controls via implementation of a WCPP or prescriptive
controls as described in Units IV.B. and IV.C. While it is possible
that 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 predicts that this potential exposure would be limited
as a result of the existing NESHAP that cover PCE for these conditions
of use under the CAA. Applicable NESHAPs include: 40 CFR part 63,
subpart F, Synthetic Organic Chemical Manufacturing Industry; 40 CFR
part 63, subpart DD, Off-Site Waste and Recovery Operations; 40 CFR
part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part 63,
subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part 63,
subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR part
63, subpart T, Halogenated Solvent Cleaning, and any exceedances would
be an enforcement issue. The CAA establishes a two-phase process for
the EPA's development, review, and potential revision of NESHAP that
impose emission standards and work practice requirements on subject
categories of sources of hazardous air pollutants. First, the EPA sets
technology-based or performance-based standards reflecting the maximum
achievable control technology (MACT) for major sources (CAA section
112(d)(2)-(3)) and generally available control technology (GACT) for
area or non-major sources (CAA section 112(d)(5)). In the second phase,
eight years after adoption of the first phase standards, the EPA
performs a residual risk review of major source MACT standards to
ensure that they provide an ample margin of safety to protect public
health (CAA section 112(f)(2)), and a technology review of all NESHAP
to account for developments in practices, processes and control
technologies (CAA section 112(d)(6)). The CAA only requires the EPA to
conduct the residual risk review one time for each MACT standard,
although the EPA has discretion to conduct additional risk reviews
where warranted. The technology review, instead, is a recurring duty,
and the EPA must perform it no less often than every eight years.
Thus, the prohibitions and restrictions on PCE in this final rule,
combined with the expected decline in production volume for PCE and the
CAA requirements described above, are expected to sufficiently address
the emissions of PCE, and thus the resulting risks identified in the
screening analysis to any general population or fenceline communities
close to facilities engaging in PCE use. EPA therefore does not intend
to revisit or conduct an analysis of the air pathway for PCE as part of
a supplemental risk evaluation.
B. Environmental Effects of PCE and the Magnitude of Environmental
Exposure 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 and the 2022 revised unreasonable risk determination
for PCE (Refs. 1, 2). 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 in Unit V.
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
(Ref. 82), as well as monitored data from the Water Quality Portal
(Ref. 83), 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
As described in the 2023 PCE proposed rule, 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
[[Page 103598]]
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, 84).
D. Reasonably Ascertainable Economic Consequences of the Final 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 final
rule include several components, all of which are described in the
Economic Analysis (Ref. 3). With respect to the anticipated effects of
this final 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 final rule would be $43.4
million annualized over 20 years at a 2% discount rate, EPA has
concluded that this rule is highly unlikely to have any measurable
effect on the national economy (Ref. 3). In addition, EPA considered
the employment impacts of this final 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 154,683 small entities affected by the final
rule with a per firm and total estimated cost impact of $177 and $27.4
million, respectively. Of the small businesses potentially impacted by
this final rule, almost 100% (154,671 out of 154,683) are expected to
have impacts of less than 1% to their firm revenues, 8 (0.00005%) are
expected to have impacts between 1 and 3% to their firm revenues, and 5
(0.00003%) are expected to have impacts greater than 3% to their firm
revenues. Most of these small entities (94%) are users of PCE in
aerosol degreasing with an estimated 119,523 small entities using PCE
in energized electrical cleaning and an estimated 26,050 small entities
using PCE in other aerosol spray cleaning/degreasing uses like brake
cleaning.
EPA estimates that there are 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 maintains 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 phaseout date.
In addition to dry cleaners, other users of PCE (such as in vapor
degreasing and use as maskant in chemical milling) could be strongly
impacted because they may have no economical alternative to the use of
PCE.
With respect to this rule's effect on technological innovation, EPA
expects this rule 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 final rule
may increase demand for safer chemical substitutes. This rule is not
likely to have significant effects on the environment because PCE does
not present an unreasonable risk to the environment, though this 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 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 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 rule are
described at length in the Economic Analysis (Ref. 3). The monetized
costs for this final rule are estimated to be $43.4 million annualized
over 20 years at a 2% discount rate. The monetized benefits are
estimated to be $32.6 to $84.6 million annualized over 20 years at a 2%
discount rate.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce an alternative regulatory action.
The alternative regulatory action is described in detail in Unit IV.B
of the 2023 PCE proposed rule. The estimated annualized cost of the
alternative regulatory action is $62.1 million at a 2% discount rate
over 20 years (Ref. 3). The monetized benefits of the alternative
action are estimated to be $32.5 to $84.4 million annualized over 20
years at a 2% discount rate (Ref. 3).
This final rule 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 Units II.A.
(overview), III.B.2. (description of the unreasonable risk), V.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 previously. 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 2023 PCE proposed
rule.
3. Cost Effectiveness of the Regulatory Action and of One 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
regulatory action is to prevent unreasonable risk resulting from
exposure to PCE. The regulatory action would cost $3.1 million per
potential prevented cancer case while the primary alternative
regulatory action would cost $4.4 million (using the 2% discount rate)
(Ref. 3).
VI. TSCA Section 9 Analysis and Section 14 and 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
[[Page 103599]]
reduced to a sufficient extent by an action taken under a Federal law
not administered by EPA, the Administrator must submit a report to the
agency administering that other law that describes the risk and the
activities that present such risk. TSCA section 9(a) describes
additional procedures and requirements to be followed by EPA and the
other Federal agency after submission of the report. As discussed in
Unit VI., the Administrator does not determine that 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. EPA's section 9(a) analysis can be found in full
in Unit VII.A. of the 2023 PCE proposed rule, and responses to comments
on that 9(a) analysis can be found in the Response to Comments, section
9.1 (Ref. 8).
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
burden of duplicative requirements. For this rulemaking, EPA has
coordinated with appropriate Federal executive departments and agencies
including but not limited to OSHA and the Consumer Product Safety
Commission (CPSC), to, among other things, identify their respective
authorities, jurisdictions, and existing laws with regard to risk
evaluation and risk management of PCE.
As discussed in more detail in the 2023 PCE proposed rule, OSHA
requires that employers provide safe and healthful working conditions
by setting and enforcing standards and by providing training, outreach,
education, and assistance. 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. The U.S. CPSC, under authority
provided to it by Congress in the Consumer Product Safety Act (CPSA),
protects the public from unreasonable risk of injury or death
associated with consumer products. Under the CPSA, CPSC has the
authority to regulate PCE in consumer products, but not in other
sectors such as automobiles, some industrial and commercial products,
or aircraft for example.
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. An action under TSCA is also able to address
occupational unreasonable risk and would reach entities that are not
subject to OSHA. Moreover, the timeframe and any exposure reduction as
a result of updating OSHA or CPSC regulations for PCE cannot be
estimated, while TSCA imposes a much more accelerated two-year
statutory timeframe for proposing and finalizing requirements to
address unreasonable risk. Regulating PCE's unreasonable risk utilizing
TSCA authority will also avoid the situation where a patchwork of
regulations amongst several Agencies using multiple laws and differing
legal standards would occur and is therefore a more efficient and
effective means of addressing the unreasonable risk of PCE. Finally, as
discussed in greater detail in the 2023 PCE proposed rule, the 2016
amendments to TSCA altered both the manner of identifying unreasonable
risk and EPA's authority to address unreasonable risk, such that risk
management is increasingly distinct from provisions of the CPSA,
Federal Hazardous Substances Act (FHSA), or OSH Act (88 FR 39652) (FRL-
8329-01-OCSPP)). 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.
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
(Refs. 3, 5), regulations under those EPA statutes 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., RCRA, CAA, CWA). Updating regulations under other EPA
statutes would not be sufficient to address the unreasonable risk of
injury to the health of workers, occupational non-users, consumers, and
bystanders who are exposed to PCE under its conditions of use. EPA's
section 9(b) analysis can be found in full in Unit VII.B. of the 2023
PCE proposed rule, and responses to comments on that 9(b) analysis can
be found in the Response to Comments, section 9.2 (Ref. 8).
For these reasons, the Administrator does not determine that
unreasonable risk from PCE under its conditions of use, as evaluated in
the 2020 Risk Evaluation for PCE (Ref. 1), 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. Under TSCA
sections 14(a) and 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). Pursuant to TSCA section
14(b)(4)(B)(iii), the presumption against protection from disclosure
will apply only to information about the specific conditions of use
that this rule prohibits or phases out. Per TSCA section
14(b)(4)(B)(i), the presumption against protection will not apply to
information about certain emergency uses that this rule exempts from a
ban or phase-out
[[Page 103600]]
pursuant to TSCA section 6(g). Manufacturers or processors seeking to
protect such information may submit a request for nondisclosure as
provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for
nondisclosure must be submitted within 30 days after receipt of notice
from EPA under TSCA section 14(g)(2)(A) stating EPA will not protect
the information from disclosure. EPA anticipates providing such notice
via the Central Data Exchange (CDX).
D. TSCA Section 26 Considerations
As explained in the 2023 PCE proposed rule, EPA fulfilled TSCA
section 26(h) by using scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science. Comments received on the 2023 PCE proposed
rule about whether EPA adequately assessed reasonably available
information under TSCA section 26 on the risk evaluation, and responses
to those comments, can be found in Section 9.3 of the Response to
Comments document (Ref. 8).
VII. 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.
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2. EPA. Perchloroethylene. Unreasonable Risk Determination. Document
ID No. EPA-HQ-OPPT-2020-0720-0036. December 2022.
3. EPA. Economic Analysis of the Final Regulation of
Perchloroethylene Under TSCA Section 6(a). RIN 2070-AK84. December
2024.
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Last Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
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Justice Consultation for TSCA PCE Risk Management of Dry Cleaning.
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Consultation USEPA TSCA PCE Risk Management. Document ID No. EPA-HQ-
OPPT-2020-0720-0061. August 20, 2021.
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19. Sa Liu; School of Health Sciences Purdue University. Letter re:
Environmental Justice Consultation on Forthcoming Proposed
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2020-0720-0064. August 20, 2021.
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0720-0126. February 2023.
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0720-0066. February 1, 2023.
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2020-0720-0002. January 14, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0002.
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January 15, 2021.
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February 2023.
30. BFK Solutions LLC. Comments on the Proposed Rulemaking for
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August 14, 2023.
31. The Boeing Company. Comments on the Proposed Rulemaking for
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Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0278.
August 15, 2023.
32. Chemical Users Coalition. Comments on the Proposed Rulemaking
for Perchloroethylene (PCE); Regulation Under the Toxic Substances
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0260.
August 15, 2023.
33. American Chemistry Council. Comments on the Proposed Rulemaking
for Perchloroethylene (PCE); Regulation Under the Toxic Substances
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0275.
August 15, 2023.
[[Page 103601]]
34. Corteva Agriscience. Comments on the Proposed Rulemaking for
Perchloroethylene (PCE); Regulation Under the Toxic Substances
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0276.
August 15, 2023.
35. EPA. Meeting with Corteva Agriscience on Risk Management under
TSCA Section 6 and Perchloroethylene (PCE). September 28, 2023.
36. Written Comments to OPPT on PCE Risk Management. Docket ID Nos.:
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37. Dow Chemical. Comments on the Proposed Rulemaking for
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August 15, 2023.
38. EPA. Meeting with Dow Chemical on Risk Management under TSCA
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39. The Campus Safety Health and Environmental Management
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August 10, 2023.
40. Christopher Kolodziej. Comments on the Proposed Rulemaking for
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August 15, 2023.
41. Purdue University. Comments on the Proposed Rulemaking for
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42. Kristi Ohr. Comments on the Proposed Rulemaking for
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43. ANSI. ANSI/ASSP Z9.5-2022; Laboratory Ventilation. https://webstore.ansi.org/standards/asse/ansiasspz92022?source=blog&_gl=1*194rqnj*_gcl_au*MjA3NzY5MzI1MS4xNzExMDMzMDEz.
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45. CRC Industries. Comments on the Proposed Rulemaking for
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46. Household and Commercial Products Association. Comments on the
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47. US Chamber of Commerce. Comments on the Proposed Rulemaking for
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48. American Petroleum Institute. Comments on the Proposed
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49. Halogenated Solvents Industry Alliance. Comments on the Proposed
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50. National Steering Committee of the State Small Business
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51. National Fire Protection Association (NFPA). NFPA 70E Standard
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OPPT-2020-0720-0077. 2004. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
78. EPA. Guidelines for Carcinogen Risk Assessment. Document ID No.
EPA-HQ-OPPT-2020-0720-0072. March 2005. https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
79. EPA. Perchloroethylene: Fenceline Technical Support--Water
Pathway. Document ID No. EPA-HQ-OPPT-2020-0720-0091. October 6,
2022.
80. EPA. Perchloroethylene: Fenceline Technical Support--Air
Pathway. Document ID No. EPA-HQ-OPPT-2020-0720-0092. December 8,
2022.
81. EPA. Final Rule. National Emission Standards for Hazardous Air
Pollutants: Carbon Black Production and Cyanide Chemicals
Manufacturing Residual Risk and Technology Reviews, and Carbon Black
Production Area Source Technology Review. Federal Register. 86 FR
66096, November 19, 2021 (FRL-7523-03-OAR).
82. EPA. Exposure and Fate Assessment Screening Tool Version 2014
(E-FAST 2014). Document ID No. EPA-HQ-OPPT-2020-0720-0094.
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.
83. National Water Quality Monitoring Council (NWQMC): Water Quality
Portal. Document ID No. EPA-HQ-OPPT-2020-0720-0095. 2017. https://www.waterqualitydata.us/.
84. 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.
85. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of
Perchloroethylene under TSCA Section 6(a). (Final Rule; RIN 2070-
AK84). EPA ICR No. 2740.02 and OMB Control No. 2070-0233. December
2024.
86. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical
Methods With Related International Voluntary Consensus Standards.
Document ID No. EPA-HQ-OPPT-2020-0720-0101. J Occup Environ Hyg.
12(7): D107-15. June 11, 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589148/.
87. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and
Perchloroethylene (PCE). June 16 and July 6, 2021.
VIII. 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 the Office of
Management and Budget (OMB) for Executive Order 12866 review.
Documentation of any changes made in response to Executive Order 12866
review is available in the docket. EPA prepared an analysis of the
potential costs and benefits associated with this action. This analysis
(Ref. 3) is available in the docket and summarized in Unit I.E.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule will be
submitted to OMB for approval 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. 2740.02, and OMB Control No. 2070-0233 (Ref.
85).) The ICR is available in the docket and is briefly summarized
here. The information collection requirements are not enforceable until
OMB approves them.
There are four primary provisions of the final 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
will be required for manufacturers, processors, and distributors in
commerce of PCE, who will provide notice to companies downstream upon
shipment of PCE about the prohibitions. The information submitted to
downstream companies through the SDS will provide knowledge and
awareness of the restrictions to these companies. The second primary
provision of the rule that may increase burden under the PRA is WCPP-
related information generation, recordkeeping, and notification
requirements (including development of exposure control plans; exposure
level monitoring and related recordkeeping; development of
documentation for a PPE program and related recordkeeping; development
of documentation for a respiratory protection program and related
recordkeeping; development and notification to potentially exposed
persons (employees and others in the workplace) about how they can
access the exposure control plans, exposure monitoring records, PPE
program implementation documentation, and respirator program
documentation; and development of documentation demonstrating
eligibility for an exemption from the proposed prohibitions, and
related recordkeeping). The third primary provision of the rule that is
expected to increase burden under the PRA is information generation
related to workplace requirements for laboratory use-related
information and generation, (including development of documentation for
a PPE program, related recordkeeping, and development of documentation
demonstrating implementation of a properly functioning ventilated
laboratory safety device). The fourth primary provision of the rule
that is expected to increase burden under the PRA is information
generation related to energized electrical cleaning, including self-
certification, recordkeeping, and notification requirements (including
development and documentation of those requirements under the specific
prescriptive controls or WCPP and related recordkeeping; development of
documentation of a self-certification statement and related
recordkeeping; notification of self-certification; and labeling).
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).
[[Page 103603]]
Estimated number of respondents: 157,760.
Frequency of response: On occasion.
Total estimated burden: 432,203 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $34,515,086 (per year), includes $2,922,680
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. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 and 609(b) of the RFA, 5 U.S.C. 601 et
seq., EPA prepared an IRFA for the 2023 PCE proposed rule and convened
a SBAR Panel to obtain advice and recommendations from SER that
potentially would be subject to the rule's requirements. Summaries of
the IRFA and Panel recommendations are presented in the 2023 PCE
proposed rule (88 FR 39652, June 16, 2023) (FRL-8329-02-OCSPP).
As required by section 604 of the RFA, EPA prepared a FRFA for this
action (Ref. 22). The FRFA addresses issues raised by public comments
on the IRFA for the 2023 PCE proposed rule. The complete FRFA is
available for review in the docket and is summarized here.
1. Statement of Need and Rule Objectives
Under section of TSCA 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 non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
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 taking action to the extent necessary so that PCE no
longer presents such risk.
EPA developed this final rule after considering EPA's unreasonable
risk determination for PCE, information provided in public comments on
the 2023 PCE proposed rule, findings from and comments on the SBAR
panel, other required consultations, and additional public outreach.
For more information on the 2023 PCE proposed rule, SBAR panel, and
outreach efforts for this action, see the docket for this rulemaking
(EPA-HQ-OPPT-2020-0720).
To address the identified unreasonable risk, this rule (1)
prohibits most industrial and commercial uses and the manufacture
(including import), processing and distribution in commerce, of PCE for
those uses; (2) prohibits the manufacture (including import),
processing, and distribution in commerce of PCE for all consumer use;
(3) prohibits the manufacture (including import), processing,
distribution in commerce, and use of PCE in dry cleaning and related
spot cleaning through a 10-year phaseout; (4) requires a WCPP,
including an inhalation exposure concentration limit, direct dermal
contact controls, and related workplace exposure controls for many
occupational conditions of use of PCE not prohibited; (5) require
prescriptive workplace controls for laboratory use and energized
electrical cleaner; (6) establish recordkeeping and downstream
notification requirements; (7) provides certain time-limited exemptions
from requirements for uses of PCE which are critical that have no
technically feasible, safer alternative available; and (8) identifies a
regulatory threshold for products containing PCE for the prohibitions
and restrictions on PCE.
2. Significant Issues Raised by the Public Comments in Response to the
IRFA and EPA Response
A summary of significant issues raised by comments about the IRFA
(Ref. 20) and EPA's response is in the Response to Comments document
(Ref. 8) in section 11.3.
3. SBA Office of Advocacy Comments and EPA Response
SBA Office of Advocacy provided comments on the 2023 PCE proposed
rule (EPA-HQ-OPPT-2020-0720). A summary of these comments and EPA's
response is in the Response to Comments document (Ref. 8) in sections
5.1.3, 5.3.2, 5.3.3, 5.8.2, 7.1, and 8.4.3.
4. Estimate of the Number of Small Entities to Which the Final Rule
Applies
The final 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 rule would affect approximately 157,760 firms using
PCE, of which 154,683 small entities (based on SBA definitions in March
2023) have estimated impacts. EPA estimates that most small entities
that use PCE use it in aerosol spray degreasing and cleaning; 119,523
in energized electrical cleaning and 26,050 in other aerosol spray
cleaning/degreasing (include brake cleaners). An estimated 5,949 of
these entities are commercial users of PCE in dry cleaning
applications. Users of products containing PCE, including adhesives and
sealants, liquid cleaners/degreasers, mold cleaners, and other products
also account for some of the affected small entities. EPA also
estimates that 69 small entities use PCE in chemical milling, 87 use
PCE in recycling and disposal, and 25 incorporate PCE into other
formulations, mixtures, and reaction products. For a full description
of the estimated number of small entities affected by this rule, see
the FRFA (Ref. 22).
5. Projected Reporting, Recordkeeping and Other Compliance Requirements
of the Final Rule
a. Compliance Requirements
EPA is prohibiting most conditions of use of PCE. As described in
the final rule, EPA is prohibiting all manufacturing (including
import), processing, and distribution in commerce of PCE for consumer
use. After the publication of the final rule, prohibitions on
manufacturing, processing, and distribution in commerce of PCE for
consumer use will occur in 540 days for manufacturers, 630 days for
processers, 720 days for distributing to retailers, and 810 days for
all other distributors and retailers.
EPA is also prohibiting most industrial and commercial uses and the
manufacture (including import), processing and distribution in commerce
of PCE for those uses. The prohibitions for these commercial uses will
become effective following prohibitions relevant to these uses in
stages of the supply chain before the industrial and commercial use
(e.g., manufacturing and processing). The restrictions follow a
staggered schedule
[[Page 103604]]
for each stage of the supply chain. After the publication of the final
rule, prohibitions come into effect in 540 days for manufacturers, 630
days for processers, 720 days for distributing to retailers, 810 days
for all other distributors and retailers, and 900 days for industrial
and commercial use.
EPA is finalizing a prohibition compliance date for commercial use
of PCE in any dry cleaning machine acquired 180 days or later after the
publication of this final rule, followed by a prohibition on the use of
PCE in 3rd generation machines 3 years after the publication of this
final rule. Full implementation of the phaseout will 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 of this 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 of this final rule.
For most other conditions of use that contribute to the
unreasonable risk from PCE, EPA is finalizing a WCPP to address the
unreasonable risk as outlined in Unit IV.B. The WCPP includes a
combination of requirements to address unreasonable risk driven by
inhalation and dermal exposures in the workplace. The PCE WCPP
encompasses restrictions on certain occupational conditions of use and
includes 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 WCPP that is necessary to
address the unreasonable risk from PCE, EPA identified certain
conditions of use where the Agency expects a WCPP can be successfully
implemented.
As described in Unit IV.B., the WCPP is non-prescriptive, in the
sense that regulated entities are not required to use specific controls
prescribed by EPA to achieve the exposure concentration limit. Rather,
it is a performance-based exposure limit that enables owners or
operators to determine how to most effectively meet the exposure limit
based on conditions at their workplace.
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 requirements include the
specific exposure limits that are 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 also finalizing a requirement for specific prescriptive
controls for the industrial and commercial use of PCE in laboratory
chemicals and specific prescriptive controls for energized electrical
cleaner as outlined in Unit IV.C. For laboratory use, EPA is requiring
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 requiring the use of laboratory ventilation
devices in workplaces engaged in the laboratory chemical condition of
use. To support and demonstrate compliance, EPA is finalizing that each
owner or operator of a laboratory workplace subject to the workplace
controls for laboratory use requirements retain compliance records for
five years. For energized electrical cleaner, EPA is requiring
labeling, self-certification, and either the WCPP or prescriptive
controls that include respiratory and dermal PPE in combination with
comprehensive training for tasks.
EPA is not requiring reporting requirements beyond downstream
notification or labeling (third-party notifications). Regarding
recordkeeping requirements, three primary provisions of the final 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 final rule, facilities complying with the
rule through the WCPP are required to develop and maintain records
associated with ECEL exposure monitoring (including measurements,
compliance with GLP Standards or use of a laboratory accredited by the
AIHA or another industry-recognized program 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. The third is
recordkeeping for business entities complying with the prescriptive
controls for laboratory use or for energized electrical cleaning. To
support and demonstrate compliance, EPA is finalizing that each owner
or operator of a workplace subject to the WCPP or specific prescriptive
controls retain compliance records for five years.
b. 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.
c. Professional Skills Needed To Comply
Entities subject to this rule that manufacture (including import),
process, or distribute PCE in commerce for consumer use would be
required to cease such activity. The entity would be required to modify
their SDS 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 final rule. None of these
activities require any special skills.
Entities that use PCE in any industrial and commercial capacity
that is prohibited would be required to cease that activity.
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 are permitted to continue to manufacture, process,
distribute, use (with the exception for use as a laboratory chemical or
use in energized electrical cleaning), or dispose of PCE are 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 or in energized electrical
cleaning are required to implement prescriptive workplace controls for
those uses and would have to meet the provisions of the workplace
restrictions for continued use of PCE. Adaption to
[[Page 103605]]
a WCPP or prescriptive workplace controls may require persons with
specialized skills such as an engineer, chemist, health and safety
professional, or laboratory technicians to process monitoring samples.
Instead of implementing the WCPP or workplace controls 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, 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 or laboratory technician. Additionally,
potentially exposed persons reasonably likely to be exposed to PCE by
inhalation to concentrations above the ECEL are required to be trained
for the proper use of respirators. Potentially exposed persons
reasonably likely to have direct dermal contact to PCE are required to
be trained for proper use of dermal protection. While this does not
necessarily entail a specialized skill, it does require specialized
training for those handling PCE within regulated areas and includes
activity-specific training for proper PPE use.
6. Steps Taken To Minimize Economic Impact to Small Entities
a. Small Business Advocacy Review Panel
As required by section 609(b) of the RFA, as amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA), EPA conducted
outreach to small entities and convened a SBAR Panel on October 27,
2022, to obtain advice and recommendations of representatives of the
small entities that potentially would be subject to the rule's
requirements. The Panel solicited input on all aspects of these
proposed regulations. Ten potentially impacted small entities served as
small-entity representatives (SERs) to the Panel, representing a broad
range of small entities from diverse geographic locations. The Panel
Report was signed on February 1, 2023.
Consistent with the RFA/SBREFA requirements, the Panel evaluated
the assembled materials and small-entity comments on issues related to
elements of the regulatory flexibility analysis. It is important to
note that the Panel's findings and discussion were based on the
information available at the time the final report was prepared. For
the full list of Panel recommendations, see section 7.A. of the FRFA
(Ref. 22).
EPA detailed the SBAR Panel's request for comment on these specific
topics in the IRFA and 2023 PCE proposed rule and solicited comment
from the public. During the comment period, the public provided comment
on some of these areas. Those comments and others received on the 2023
PCE proposed rule and EPA's responses are in the Response to Comments
document in the docket (Ref. 8).
b. Alternatives Considered
To identify the regulatory approach that would address the
unreasonable risk from PCE, 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 list 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. of the
2023 PCE proposed rule, and Unit II.D. of the final rule, 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 rule. As
part of this analysis, EPA considered a wide variety of control
measures to address the unreasonable risk from PCE such as weight
fractions, prescriptive controls, and a certification and limited
access program. EPA's consideration of these alternative control
measures is described in detail in the IRFA for the 2023 PCE proposed
rule, and throughout Unit V.A. of the 2023 PCE proposed rule.
Based on consideration of public comments received on the 2023 PCE
proposed rule, EPA has made some changes from the 2023 PCE proposed
rule to the final rule. These changes include the finalization of
additional conditions of use under the WCPP or prescriptive controls
rather than prohibition, prohibition of additional conditions of use
rather than the WCPP, and changes to compliance timeframes for
prohibition and the WCPP. Additional changes to the rule based on
consideration of public comments are detailed Unit III. of the final
rule and include modifications to provisions of the WCPP. For
additional information and rationale towards alternative actions, see
Unit III.D. of this final rule and section 7.B. of the FRFA (Ref. 22).
In addition, EPA is preparing a Small Entity Compliance Guide to
help small entities comply with this rule. EPA expects that this guide
will be made available on the EPA website prior to the effective date
of this final rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(adjusted annually for inflation) or more (in 1995 dollars) as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The action will 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.
The costs involved in this action are estimated not to exceed $183
million in 2023$ ($100 million in 1995$ adjusted for inflation using
the GDP implicit price deflator) or more in any one year.
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. EPA
provides the following 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. A summary of the meeting with these
organizations, including the views that they expressed, is available in
the docket (Ref. 13). 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,
[[Page 103606]]
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. PCE is not
manufactured, processed, or distributed in commerce by Tribes, and
therefore, this rulemaking would not impose substantial direct
compliance costs on Tribal governments.
Notwithstanding the lack of Tribal implications as specified by
Executive Order 13175, EPA consulted with Tribal officials during the
development of this action, consistent with the EPA Policy on
Consultation and Coordination with Indian Tribes, which EPA applies
more broadly than Executive Order 13175.
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
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 sought from Tribes (Ref. 14).
EPA briefed Tribal officials on the Agency's risk management
considerations and Tribal officials raised no related issues or
concerns to EPA during or in follow-up to those meetings (Ref. 14). EPA
received no written comments as part of this consultation.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in federal health and safety
standards and explain why the regulation is preferable to potentially
effective and reasonably feasible alternatives. This action is not
subject to Executive Order 13045 (62 FR 19885, April 23, 1997) 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. EPA did not find that
the adverse health impacts for children and for men and women of
reproductive age was disproportionate in comparison to other
populations. EPA's Policy on Children's Health applies to this action.
Information on how the Policy was applied and on the action's health
and risk assessments are contained in Units III.A.3. and B.2., VI.A.
and B., and the 2020 Risk Evaluation for PCE (Ref. 1) and the Economic
Analysis for the 2023 PCE proposed rule (Ref. 3).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy 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), EPA will not 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. 71). EPA recognizes that there may be voluntary consensus
standards that meet the criteria (Ref. 86).
J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionate and adverse human health or environmental effects on
communities with environmental justice concerns in accordance with
Executive Order 12898 (59 FR 7629, February 16, 1994) and Executive
Order 14096 (88 FR 25251, April 26, 2023). As described more fully in
the Economic Analysis for this rulemaking (Ref. 3), EPA conducted an
analysis to characterize the baseline conditions faced by communities
and workers affected by the regulation to identify the potential for
disproportionate impacts on communities with environmental justice
concerns using information about the facilities, workforce, and
communities potentially affected by the regulatory options under
current conditions, before the regulation would go into effect. The
analysis drew on publicly available data provided by EPA, U.S. Census
Bureau, and Centers for Disease Control and Prevention, including data
from TRI, EPA Enforcement and Compliance History Online, National Air
Toxics Assessment, the American Community Survey, and the Behavioral
Risk Factor Surveillance System. 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 effect on communities with environmental
justice concerns. This regulatory action would apply requirements to
the extent necessary so that PCE no longer presents an unreasonable
risk, EPA is not able to quantify the distribution of the change in
risk across affected populations due to data limitations that prevented
EPA from conducting a more comprehensive analysis of such a change.
EPA additionally identified and addressed environmental justice
concerns by conducting outreach to communities with environmental
justice concerns. For example, on June 16 and July 6, 2021, EPA held
public meetings as part of this consultation (Ref. 87). These meetings
were held pursuant to and in compliance with Executive Order 12898 and
Executive Order 14008, Tackling the Climate Crisis at Home and Abroad
(86 FR 7619, February 1, 2021). EPA received five written comments
following the EJ meetings, in addition to oral comments provided during
the consultations. In general, commenters
[[Page 103607]]
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
and Executive Order 14096 is contained in Units I.E., II.D., III.A.1.,
VI.A., and in the Economic Analysis (Ref. 3). EPA's presentations, a
summary of EPA's presentation and public comments made, 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.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
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 amends 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
``Designated representative,'' ``Direct dermal contact,'' ``ECEL,'' and
``Exposure group'' to read as follows:
Sec. 751.5 Definitions.
* * * * *
Designated representative means any individual or organization to
whom a potentially exposed person gives written authorization to
exercise a right of access. A recognized or certified collective
bargaining agent must be treated automatically as a designated
representative without regard to written authorization.
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 calculated as an eight (8)-hour time-weighted average
(TWA).
* * * * *
Exposure group means a group of potentially exposed persons with a
similar exposure profile to a chemical substance or mixture based on
the substantial similarity of tasks performed, the manner in which the
tasks are performed, and the materials and processes with which they
work.
* * * * *
0
3. Amend part 751 by adding Subpart G to read as follows:
Subpart G--Perchloroethylene (PCE)
Sec.
751.601 General.
751.603 Definitions.
751.605 Prohibitions of manufacturing, processing, distribution in
commerce, and use.
751.607 Workplace Chemical Protection Program (WCPP).
751.609 Workplace requirements for laboratory use.
751.611 Workplace requirements for energized electrical cleaner.
751.613 Downstream notification.
751.615 Recordkeeping requirements.
751.617 Exemptions.
Sec. 751.601 General.
(a) Applicability. This Subpart establishes prohibitions and
restrictions on the manufacture (including import), processing,
distribution in commerce, use, and disposal of perchloroethylene (CASRN
127-18-4) (PCE), also known as tetrachloroethylene, to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Regulatory threshold. Unless otherwise specified in this
Subpart, the prohibitions and restrictions of this Subpart do not apply
to products containing PCE at thresholds less than 0.1 percent by
weight.
(c) Owner and operator requirements. Any requirement for an owner
or operator, or an owner and operator, is a requirement for any
individual that is either an owner or an operator.
Sec. 751.603 Definitions.
The definitions in Subpart A of part 751 apply to this Subpart
unless otherwise specified in this section. In addition, the following
definitions apply to this Subpart:
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.
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. 751.613 and 751.615.
ECEL has the same meaning as in Sec. 751.5 and, for PCE, is an
airborne concentration of PCE of 0.14 part per million (ppm).
ECEL action level means a concentration of airborne PCE of 0.10
part per million (ppm) calculated as an eight (8)-hour time-weighted
average (TWA).
Energized electrical cleaner means a product that meets both of the
following criteria: (1) the product is labeled to clean and/or degrease
electrical equipment, where cleaning and/or degreasing is accomplished
when electrical current exists, or when there is a residual electrical
potential from a component, such as a capacitor; and (2) the product
label clearly displays the statements: ``Energized Equipment use only.
Not to be used for motorized vehicle maintenance, or their parts.''
Sec. 751.605 Prohibitions of manufacturing, processing, distribution
in commerce, and use.
(a) Applicability. (1) The provisions of this section apply as
indicated in paragraph (b) of this section to all manufacturing
(including import), processing, and distribution in commerce of PCE for
consumer use.
(2) The provisions of this section apply as indicated in paragraph
(b) of this section to:
(i) All manufacturing (including import), processing, and
distribution in commerce of PCE for industrial and commercial use,
other than for the
[[Page 103608]]
industrial and commercial uses addressed under Sec. Sec. 751.607(a),
751.609(a), and 751.611(a), or covered by paragraph (a)(3) of this
section; and
(ii) All industrial and commercial use of PCE, other than the
industrial and commercial uses addressed under Sec. Sec. 751.607(a),
751.609(a), and 751.611(a), or covered by paragraph (a)(3) of this
section.
(3) The provisions of this section apply as indicated in paragraph
(b) of this section to all manufacturing (including import),
processing, distribution in commerce, and industrial and commercial use
of PCE in dry cleaning and related spot cleaning, 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) This section does not apply to the distribution in commerce or
use of clothing and articles that have been commercially dry cleaned
with PCE.
(5) This section does not apply to manufacturing, processing, or
distribution in commerce of PCE solely for export that meets the
conditions described in TSCA section 12(a)(1)(A) and (B).
(b) Prohibitions. (1) After June 11, 2026, all persons are
prohibited from manufacturing (including importing) PCE for the uses
listed in paragraphs (a)(1) and (a)(2)(ii) of this section.
(2) After September 9, 2026, all persons are prohibited from
processing PCE, including any PCE-containing products, for the uses
listed in paragraphs (a)(1) and (a)(2)(ii) of this section.
(3) After December 8, 2026, all persons are prohibited from
distributing in commerce (including making available) PCE, including
any PCE-containing products, to retailers for any use other than
commercial dry cleaning.
(4) After March 8, 2027, all retailers are prohibited from
distributing in commerce (including making available) PCE, including
any PCE-containing products.
(5) After March 8, 2027, all persons are prohibited from
distributing in commerce (including making available) PCE, including
any PCE-containing products, for the uses described in paragraphs
(a)(1) and (a)(2)(ii) of this section.
(6) After June 7, 2027, all persons are prohibited from industrial
or commercial use of PCE, including any PCE-containing products, for
the uses listed in paragraph (a)(2)(ii) of this section.
(7) All persons are prohibited from industrial or commercial use of
PCE in dry cleaning machines acquired after June 16, 2025.
(8) After December 20, 2027, all persons are prohibited from
industrial or commercial use of PCE for the use listed in paragraph
(a)(3)(i) of this section.
(9) After December 19, 2034, all persons are prohibited from the
manufacturing (including importing), processing, distribution in
commerce, or industrial or commercial use of PCE for dry cleaning and
spot cleaning, including for the use listed in paragraph (a)(3)(ii) of
this section.
(10) After December 19, 2034, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of PCE, including any PCE containing products, for industrial or
commercial use in an emergency by the National Aeronautics and Space
Administration or its contractors as described in Sec. 751.117(b).
Sec. 751.607 Workplace Chemical Protection Program (WCPP).
(a) Applicability. The provisions of this section apply to the
following conditions of use of PCE, including manufacturing and
processing for export, 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;
(5) Repackaging;
(6) Industrial and commercial use as solvent for open-top batch
vapor degreasing;
(7) Industrial and commercial use as solvent for closed-loop batch
vapor degreasing
(8) Industrial and commercial use in maskant for chemical milling;
(9) Industrial and commercial use in solvent-based adhesives and
sealants;
(10) Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing;
(11) Industrial and commercial use as a processing aid in sectors
other than petrochemical manufacturing;
(12) Industrial and commercial use for cold cleaning of tanker
vessels;
(13) Recycling; and
(14) 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 paragraph (a)(1) through (12) of
this section and not prohibited by Sec. 751.605.
(2) Eight-hour time-weighted average (TWA) ECEL. Beginning
September 20, 2027 for Federal agencies and Federal contractors acting
for or on behalf of the Federal government, March 13, 2026 for non-
Federal owners and operators, or beginning four months after
introduction of PCE into the workplace if PCE use commences after
December 15, 2025, the owner or operator must ensure that no person is
exposed to an airborne concentration of PCE in excess of the ECEL,
consistent 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, without regard to respiratory protection, 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 exposure group.
(B) Personal breathing zone air samples are representative of the
8-hour TWA of all potentially exposed persons in an exposure group if
the samples are of at least one person's full-shift exposure who
represents the highest potential PCE exposures in that exposure group.
Personal breathing zone air samples taken during one work shift may be
used to represent potentially exposed person exposures on other work
shifts where the owner or operator can document that the tasks
performed and conditions in the workplace are similar across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice (GLP) Standards in 40 CFR part 792 or a laboratory
accredited by the American Industrial Hygiene Association (AIHA) or
another industry-recognized program.
(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 PCE.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect, unless an Environmental Professional as defined at 40 CFR
312.10 or a Certified Industrial Hygienist reviews the
[[Page 103609]]
monitoring results and determines re-monitoring is not necessary.
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
by December 15, 2025 for non-Federal owners and operators, or within 30
days of introduction of PCE into the workplace, whichever is later,
each owner or operator covered by this section must perform initial
monitoring of potentially exposed persons. Where the owner or operator
has monitoring results from monitoring conducted within five years
prior to February 18, 2025 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 this
paragraph.
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to PCE
in accordance with table 1.
Table 1 to Sec. 751.607(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
ECEL action level (<0.10 ppm 8-hour required at least once every
TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (>0.14 ppm 8-hour TWA). of the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (>=0.10 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 five years of
taken at least seven days apart within the most recent exposure
a 6 month period, indicate exposure is monitoring.
below the ECEL action level (<0.10 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 PCE in of cessation of use of PCE is
that condition of use over the required; and periodic
entirety of time since the last monitoring is required when
required monitoring event. the owner or operator resumes
the condition of use.
------------------------------------------------------------------------
(iv) Additional monitoring. (A) The owner or operator must conduct
the exposure monitoring required by paragraph (b)(3)(ii) of this
section within 30 days after 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. Prior monitoring data cannot be used to meet this
requirement.
(B) Whenever start-ups or shutdowns, or spills, leaks, ruptures or
other breakdowns or unexpected releases occur that may lead to exposure
to potentially exposed persons, the owner or operator must conduct the
exposure monitoring required by paragraph (b)(3)(ii) of this section
within 30 days after the conclusion of the start-up or shutdown and/or
the cleanup of the spill or repair of the leak, rupture or other
breakdown. Prior monitoring data cannot be used to meet this
requirement.
(v) Observation of monitoring. (A) Owners and operators must
provide potentially exposed persons or their designated representatives
an opportunity to observe any monitoring of occupational exposure to
PCE that is conducted under this section and designed to characterize
their exposure.
(B) When monitoring observation requires entry into a regulated
area, the owner or operator must provide the observers with the
required PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group and their designated representatives of any
monitoring results within 15 working days of receipt of those
monitoring results.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level;
(3) Statement of whether the monitored airborne concentration of
PCE exceeds the ECEL action level or ECEL;
(4) If the ECEL is exceeded, descriptions of any exposure controls
implemented by the owner or operator to reduce exposures to or below
the ECEL, as required by paragraph (d)(1) of this section;
(5) Explanation of any respiratory protection provided in
accordance with paragraphs (b)(4)(iv), (d)(1)(i), and (f) of this
section;
(6) Quantity of PCE in use at the time of monitoring;
(7) Location of PCE use at the time of monitoring;
(8) Manner of PCE use at the time of monitoring; and
(9) Identified releases of PCE.
(C) Notice must be written in plain language and either provided to
each potentially exposed person and their designated representatives
individually in a language that the person understands, 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) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government and by March 13, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of PCE exceed or can reasonably be expected to exceed,
the ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. 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 PCE within the
regulated area.
(iv) Provisions of respirators. (A) The owner or operator must
ensure that each
[[Page 103610]]
person who enters a regulated area is supplied with a respirator
selected in accordance with paragraph (f) of this section and must
ensure that all persons within the regulated area are using the
provided respirators whenever PCE exposures may exceed the ECEL.
(B) An owner or operator who has implemented all feasible 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 PCE 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.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase PCE exposure.
(B) 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 performance.
(c) DDCC. Beginning September 20, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government
and beginning March 13, 2026 for non-Federal owners and operators,
owners or operators must ensure that all persons are separated,
distanced, physically removed, or isolated from direct dermal contact
with PCE consistent 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) By December 20, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 7, 2027 for non-Federal owners and operators, 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,
in accordance with the hierarchy of controls.
(B) If the feasible controls required under paragraph (d)(1)(i)(A)
of this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL, then the owner or
operator must use such controls to reduce exposure to the lowest levels
achievable by these controls and must supplement those controls with
the use of respiratory protection that complies with the requirements
of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate exposure to PCE
has been reduced to or below the ECEL through the use of controls
required under paragraphs (d)(1)(i)(A) and (B) of this section, and has
not demonstrated that it has appropriately supplemented with
respiratory protection that complies with the requirements of paragraph
(f) of this section, this will constitute a failure to comply with the
ECEL.
(ii) DDCC requirements. (A) By December 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 7, 2027 for non-Federal owners and operators,
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 PCE
except to the extent that the owner or operator can demonstrate that
such controls are not feasible.
(B) If the feasible controls required under paragraph (d)(1)(ii)(A)
of this section that can be instituted do not prevent direct dermal
contact, then the owner or operator must use such controls to reduce
direct dermal contact to the extent achievable by these controls and
must supplement those controls with the use of dermal protection that
complies with the requirements of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate direct dermal
contact to PCE is prevented through the use of controls required under
paragraphs (d)(1)(ii)(A) and (B) of this section, and has not
demonstrated that it has appropriately supplemented with dermal
protection 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.
(2) Exposure control plan. By December 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 7, 2027 for non-Federal owners and operators,
each owner and operator must establish and implement an exposure
control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraphs (d)(1)(i)(A) and (d)(1)(ii)(A) of this section, in the
following sequence: elimination, substitution, engineering controls and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement exposure controls selected, including proper installation,
regular inspections, maintenance, training or other actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls; and
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to PCE, or otherwise result in increased exposure to PCE,
including procedures for implementing corrective actions to mitigate
exposure to PCE.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls instituted under this paragraph (d).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) through (d) of this section.
(iii) Availability of exposure control plan. (A) Owners or
operators must make the exposure control plan and associated records,
including ECEL exposure monitoring records, ECEL compliance records,
DDCC compliance records, and workplace participation records described
in Sec. 751.615(b), available to potentially exposed persons and their
designated representatives.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated
[[Page 103611]]
records must be provided in plain language writing to each potentially
exposed person in a language that the person understands 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.
(D) Upon request by the potentially exposed person or their
designated representative(s), the owner or operator must provide the
specified records at a reasonable time, place, and manner. If the owner
or operator is unable to provide the requested records within 15
working days, the owner or operator must, within those 15 working days,
inform the potentially exposed person or designated representative(s)
requesting the record(s) of the reason for the delay and the earliest
date when the record will be made available.
(e) Workplace information and training. (1) By March 13, 2026, the
owner or operator must institute a training program and ensure that
persons potentially exposed to PCE participate in the program according
to the requirements of this paragraph (e).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of a potential exposure to
PCE.
(3) 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.
(4) The following information and training must be provided to all
persons potentially exposed to PCE:
(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
PCE and the specific operations in the workplace that could result in
exposure to PCE, particularly noting where each regulated area is
located;
(iii) 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);
(iv) The acute and chronic health hazards of PCE as detailed on
relevant Safety Data Sheets; and
(v) The principles of safe use and handling of PCE and measures
potentially exposed persons can take to protect themselves from PCE,
including specific procedures the owner or operator has implemented to
protect potentially exposed persons from exposure to PCE, such as
appropriate work practices, emergency procedures, and personal
protective equipment to be used.
(5) 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 PCE in the
workplace.
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where such exposure exceeds 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
and ensure that each potentially exposed person is re-trained.
(f) Personal protective equipment (PPE)--(1) Protection. The
provisions of paragraph (f) apply to any owner or operator that is
required to provide respiratory protection pursuant to paragraphs
(b)(4)(iv) or (d)(1)(i)(B) of this section or Sec. 751.611(b), or
dermal protection pursuant to paragraphs (c) or (d)(1)(ii)(B) of this
section, Sec. 751.609(b)(2), or Sec. 751.611(b).
(2) Respiratory protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, by March 13, 2026 for non-Federal owners and operators, or
within three months after receipt of any exposure monitoring that
indicates exposures exceeding the ECEL, if an owner or operator is
required to provide respiratory protection pursuant to paragraph (f)(1)
of this section, the owner or operator must ensure that each
potentially exposed person is provided with a respirator according to
the requirements of this section.
(ii) For purposes of this paragraph (f)(2), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are
defined in 29 CFR 1910.134(b) have the meaning assigned to them in that
paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
March 13, 2026 for non-Federal owners and operators, or within three
months after receipt of any exposure monitoring that indicates
exposures exceeding the ECEL, if an owner or operator is required to
provide respiratory protection pursuant to paragraph (f)(1) of this
section, the owner or operator must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection
required by paragraph (f)(2)(i) of this section based on a medical
evaluation consistent with the requirements of 29 CFR 1910.134(e). If a
potentially exposed person cannot use a negative-pressure respirator
that would otherwise be required by paragraph (f)(1) of this section,
then the owner or operator must provide that person with an alternative
respirator. The alternative respirator must have less breathing
resistance than the negative-pressure respirator and provide equivalent
or greater protection. If the person is unable to use an alternative
respirator, then the person must not be permitted to enter the
regulated area.
(v) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator
selections to each affected person consistent with the requirements of
29 CFR 1910.134(f),1910.134 App A.
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j),1910.134 App. B-1 to B-2.
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to PCE, owners and operators must provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k), 1910.134 App. D.
(viii) Owners and operators must retrain all persons required to
use PPE at least 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.
(ix) 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 1.4 ppm (10 times ECEL): Any National Institute
for Occupational Safety and Health
[[Page 103612]]
(NIOSH) Approved[supreg] air-purifying half mask respirator equipped
with organic vapor cartridges or canisters; or any NIOSH
Approved[supreg] Supplied-Air Respirator (SAR) or Airline Respirator
operated in demand mode equipped with a half mask; or any NIOSH
Approved[supreg] Self-Contained Breathing Apparatus (SCBA) in a demand
mode equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 1.4 ppm and
less than or equal to 3.5 ppm (25 times ECEL): Any NIOSH
Approved[supreg] Powered Air-Purifying Respirator (PAPR) equipped with
a loose-fitting facepiece or hood/helmet equipped with organic vapor
cartridges or canisters; or any NIOSH Approved[supreg] SAR or Airline
Respirator in a continuous-flow mode equipped with a loose-fitting
facepiece or helmet/hood [APF 25].
(D) If the measured exposure concentration is above 3.5 ppm and
less than or equal to 7.0 ppm (50 times ECEL): Any NIOSH
Approved[supreg] air-purifying full facepiece respirator equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg] PAPR
with a half mask equipped with organic vapor cartridges or canisters;
any NIOSH Approved[supreg] SAR or Airline Respirator in a continuous
flow mode equipped with a half mask; any NIOSH Approved[supreg] SAR or
Airline Respirator operated in a pressure-demand or other positive-
pressure mode with a half mask; or any NIOSH Approved[supreg] SCBA in
demand-mode equipped with a full facepiece or helmet/hood [APF 50].
(E) If the measured exposure concentration is above 7.0 ppm and
less than or equal to 140 ppm (1,000 times ECEL): Any NIOSH
Approved[supreg] PAPR equipped with a full facepiece equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg] SAR
or Airline Respirator in a continuous-flow mode equipped with full
facepiece; any NIOSH Approved[supreg] SAR or Airline Respirator in
pressure-demand or other positive-pressure mode equipped with a full
facepiece and an auxiliary self-contained air supply; or any NIOSH
Approved[supreg] SAR or Airline Respirator in a continuous-flow mode
equipped with a helmet or hood and that has been tested to demonstrated
performance at a level of a protection of APF 1,000 or greater [APF
1000].
(F) If the measured exposure concentration is greater than 140 ppm
(1,000+ times ECEL): Any NIOSH Approved[supreg] Self-Contained
Breathing Apparatus (SCBA) in a pressure-demand or other positive-
pressure mode equipped with a full facepiece or helmet/hood [APF
10,000].
(G) If the exposure concentration is unknown: Any NIOSH
Approved[supreg] combination supplied air respirator equipped with a
full facepiece and operated in pressure demand or other positive
pressure mode with an auxiliary self-contained air supply; or any NIOSH
Approved[supreg] SCBA operated in pressure demand or other positive
pressure mode and equipped with a full facepiece or hood/helmet [APF
1000+].
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(2) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select respirators that have an end-of-service-life indicator
(ESLI) that is NIOSH Approved[supreg] for PCE; or
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The
written respiratory protection program required by paragraph
(f)(2)(iii) of this section must include a description of the
information and data relied upon, the basis for reliance on the
information and data, and the basis for the canister and cartridge
change schedule.
(xii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29
CFR 1910.134(l), to ensure that the provisions of the written
respiratory protection program required under paragraph (f)(2)(iii) of
this section are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph
(f)(2) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(3) Dermal protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by March 13, 2026 for non-Federal owners and operators,
if an owner or operator is required to provide dermal protection
pursuant to paragraph (f)(1) of this section, the owner or operators
must ensure that each potentially exposed person is provided with
dermal PPE according to the requirements of this section.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with PCE in the specific work area where it is selected
for use, selected in accordance with this paragraph (f)(3) 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 PCE. For the purposes of this paragraph (f)(3)(ii),
provisions in 29 CFR 1910.132(h) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(iii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in
this paragraph (f)(3) to each person who is reasonably likely to be
dermally exposed in the work area through direct dermal contact with
PCE. For the purposes of this paragraph (f)(3)(iii), provisions in 29
CFR 1910.133(b) applying to an ``employer'' also apply equally to
owners or operators.
(iv) 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. Replacement PPE must be
provided immediately 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. Dermal PPE must include, but is not limited to,
the following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier or by individually prepared third-party
testing.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(v) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with PCE during normal and expected duration and
conditions of exposure within the work area by evaluating the
specifications from the manufacturer or supplier or individually
prepared third-party testing of the dermal PPE or of the material used
in construction of the dermal PPE, to establish that the dermal PPE
will be impervious to PCE alone
[[Page 103613]]
and in likely combination with other chemical substances in the work
area.
(vi) Dermal PPE 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.
(vii) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to PCE. For the purposes of this paragraph (f)(3)(vii),
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.
(viii) Owners and operators must retrain each person required to
use dermal protection at least 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 dermal
protection, or when changes in the workplace or in dermal protection to
be used render the previous training obsolete.
Sec. 751.609 Workplace requirements for laboratory use
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of PCE as a laboratory chemical.
(b) Laboratory use requirements. (1) After December 15, 2025,
owners or operators must ensure laboratory ventilation devices such as
fume hoods or glove boxes 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 potentially exposed persons
in the area when PCE is used in a laboratory setting.
(2) After December 15, 2025, owners or operators must ensure that
all persons reasonably likely to be exposed from direct dermal contact
to PCE in a laboratory setting are provided with dermal personal
protective equipment and training on proper use of PPE in a manner
consistent with Sec. 751.607(f)(3), except that the date listed in
paragraph (f)(3)(i) does not apply.
Sec. 751.611 Workplace requirements for energized electrical cleaner.
(a) Applicability. The provisions of this section apply as
indicated in paragraphs (b) through (d) of this section to:
(1) All manufacturing (including importing), processing, and
distribution in commerce of PCE for industrial and commercial use as
energized electrical cleaner, and
(2) Industrial and commercial use of PCE as energized electrical
cleaner.
(b) Energized electrical cleaner requirements. The provisions of
this paragraph (b) apply to any workplace engaged in the condition of
use listed in paragraph (a)(2).
(1) PPE. (i) The provisions of this paragraph (b)(1) apply after
March 13, 2026.
(ii) Owners or operators must ensure that all potentially exposed
persons using PCE, including any PCE containing products, are provided
with dermal PPE and training on proper use of PPE in accordance with
Sec. 751.607(f)(3).
(iii) If any of the criteria in paragraphs (b)(1)(iii)(A) or (B)
are met, then owners or operators must ensure that all persons using
PCE, including any PCE containing products, are provided with
respiratory PPE and training on proper use of PPE in accordance with
Sec. 751.607(f)(2), except that instead of selecting appropriate
respirators based on monitoring results pursuant to paragraph
(f)(2)(ix), owners or operators must select from and provide the
following types of respirators: any NIOSH Approved[supreg] air-
purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] PAPR with a half
mask equipped with organic vapor cartridges or canisters; any NIOSH
Approved[supreg] SAR or Airline Respirator in a continuous flow mode
equipped with a half mask; any NIOSH Approved[supreg] SAR or Airline
Respirator operated in a pressure-demand or other positive-pressure
mode with a half mask; any NIOSH Approved[supreg] SCBA in demand-mode
equipped with a full facepiece or helmet/hood [APF 50]; or any
respirator affording a higher degree of protection.
(A) The potentially exposed person is in a confined space, as
defined in 29 CFR 1910.146(b), or in an enclosed space, as described in
29 CFR 1910.269(e); or
(B) The potentially exposed person approaches the exposed energized
equipment closer than the employer's established minimum approach
distance required under 29 CFR 1910.269(l)(3) or when there is no
established minimum approach distance.
(2) Alternative to PPE requirements. (i) As an alternative to the
requirements in paragraph (b)(1) of this section, the owner or operator
may choose to follow the WCPP provisions in Sec. 751.607.
(ii) Owners or operators who choose to follow the WCPP as an
alternative to the requirements in paragraph (b)(1) of this section
must:
(A) Document and maintain a statement that they are electing to
comply with the WCPP.
(B) Comply with the WCPP provisions in Sec. 751.607 and document
compliance in accordance with Sec. 751.615(b).
(c) Label. After March 13, 2026, all manufacturers (including
importers), processors and distributors in commerce of PCE or PCE-
containing products for industrial and commercial use as energized
electrical cleaner must provide a label securely attached to each
product. Label information must be prominently displayed and in an
easily readable font size, with the sentences: ``This product contains
perchloroethylene (PCE) (CASRN 127-18-4), a chemical determined by the
Environmental Protection Agency to present unreasonable risk of injury
to health under the Toxic Substances Control Act (TSCA), based on
neurotoxicity and other adverse health effects. The use of PCE is
restricted under 40 CFR part 751, subpart G. This product is for
Energized Equipment use only. Not to be used for motorized vehicle
maintenance, or their parts.''
(d) Self-certification. After March 13, 2026, the owner or operator
of the business entity purchasing and using PCE, including any PCE
containing products, for the industrial and commercial use as energized
electrical cleaner must self-certify that use is in compliance with
requirements of paragraph (b) of this section with the following
written statement.
(1) The self-certification must include the following written
statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. This
energized electrical cleaner will be used for energized equipment
use only. This business entity has implemented and complies with the
EPA requirements for the use of energized electrical cleaner that
contains perchloroethylene under 40 CFR 751.611 and only trained and
qualified persons will handle the energized electrical cleaner.
Based on my inquiry of the person or persons who manages this
business entity and/or those persons directly responsible for
implementing the EPA requirements for energized electrical cleaner
that contains perchloroethylene, and to the best of my knowledge and
belief, this business entity is in compliance with the EPA
requirements for energized electrical cleaner. I am aware that there
are significant penalties, including the possibility of civil
penalties for failing to comply with these requirements and criminal
fines and imprisonment, for knowingly
[[Page 103614]]
failing to comply with these requirements. I understand that this
certification shall serve as a certification that this business
entity will properly implement and comply with the EPA requirements
for energized electrical cleaner consistent with the applicable
regulatory timelines.
(2) The self-certification must also include the following:
(i) Printed name and signature, job classification, title, email
address, and phone number of the owner or operator who is self-
certifying.
(ii) Date of self-certification.
(iii) Name and address of the business entity.
(iv) Indication of whether this is the business entity's first
purchase of PCE, including PCE containing products, after publication
of the final rule.
(3) Owners or operators or persons specifically authorized by the
owner or operator to purchase energized electrical cleaner must provide
a copy of the self-certification statement for each business entity to
the distributor from whom PCE, including PCE containing products, is
being purchased, for every purchase.
(4) Distributors of PCE, including PCE containing products, must
review the self-certification statement to ensure it is appropriately
completed to include the owner or operator's and the business entity's
information required by this section.
(5) Distributors of PCE, including PCE containing products, must
have a complete and valid self-certification statement in accordance
with this section for each sale of PCE, including PCE containing
products, for use in energized electrical cleaning.
Sec. 751.613 Downstream notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) PCE for any use must, prior to or concurrent with
the shipment, notify companies to whom PCE is shipped, in writing, of
the restrictions described in this Subpart in accordance with paragraph
(c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce PCE or any PCE-containing products for any use
must, prior to or concurrent with the shipment, notify companies to
whom PCE 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 PCE or with any
PCE-containing product:
After December 8, 2026 this chemical substance (as defined in
TSCA section 3(2))/product cannot be distributed in commerce to
retailers for any use. After March 8, 2027, this chemical substance
(as defined in TSCA section 3(2))/product is and can only be
distributed in commerce or processed with a concentration of PCE
equal to or greater than 0.1% by weight for the following purposes:
(1) Processing as a reactant/intermediate; (2) Processing into
formulation, mixture or reaction product; (3) Processing by
repackaging; (4) Recycling; (5) Industrial and commercial use as
solvent in open-top batch vapor degreasing; (6) Industrial and
commercial use as solvent in closed-loop batch vapor degreasing; (7)
Industrial and commercial use in maskant for chemical milling; (8)
Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing; (9) Industrial and
commercial use as a processing aid in sectors other than
petrochemical manufacturing; (10) Industrial and commercial use as
solvent for cold cleaning of tanker vessels; (11) Industrial and
commercial use as energized electrical cleaner; (12) Industrial and
commercial use in laboratory chemicals; (13) Industrial and
commercial use in solvent-based adhesives and sealants; (14)
Industrial and commercial use in dry cleaning in 3rd generation
machines until December 20, 2027; (15) Industrial and commercial use
in all dry cleaning and related spot cleaning until December 19,
2034; (16) Export; and (17) Disposal.
Sec. 751.615 Recordkeeping requirements.
(a) General records. After February 18, 2025, all persons who
manufacture (including import), process, distribute in commerce, or
engage in industrial or commercial use of PCE or PCE-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 G.
(b) WCPP compliance--(1) ECEL exposure monitoring. For each
monitoring event, owners or operators subject to the ECEL described in
Sec. 751.607(b) must document and retain records of the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of PCE use at the time of
each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.607(b)(3)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.607(b)(3)(i)(D);
(vii) Compliance with the GLP Standards in 40 CFR part 792, or use
of a laboratory accredited by the AIHA or another industry-recognized
program, as required by Sec. 751.607(b)(3)(i)(C); and
(viii) Information regarding air monitoring equipment, including:
Type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions;
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.607(b)(3)(v).
(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) Implementation of the exposure control plan as described in
Sec. 751.607(d)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes an exceedance of the ECEL and
any subsequent corrective actions taken by the owner or operator during
the start-up, shutdown, or malfunctions to mitigate exposures to PCE.
(iii) Respiratory protection used by each potentially exposed
person and PPE program implementation as described in Sec.
751.607(f)(2) including:
(A) The name, workplace address, work shift, job classification,
work area of each potentially exposed person, and the type of
respiratory protection provided to each potentially exposed person;
(B) The basis for the specific respiratory protection selection in
accordance with Sec. 751.607(f)(2); and
(C) Fit testing and training in accordance with Sec.
751.607(f)(2).
(iv) Information and training provided 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)(2);
(ii) Dermal protection used by each potentially exposed person and
PPE
[[Page 103615]]
program implementation as described in Sec. 751.607(f)(3), 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 be 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 Sec. 751.607(f)(3).
(iii) Information and training provided 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 PCE inhalation exposure or direct dermal
contact and their designated representatives to readily access the
exposure control plans, facility exposure monitoring records, PPE
program implementation records, or any other information relevant to
PCE 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. 751.615(b)(3)(ii);
(2) Documentation identifying: Criteria that the owner or operator
will use to determine and implement control measures to reduce
potentially exposed persons' exposure to PCE including laboratory
ventilation devices;
(3) Documentation identifying: Implementation of properly
functioning laboratory ventilation devices using manufacturer's
instructions for installation, use, and maintenance of the devices
including inspections, tests, development of maintenance procedures,
the establishment of criteria for acceptable test results, and
documentation of test and inspection results; and
(d) Workplace requirements for energized electrical cleaner. (1)
Owners and operators subject to the energized electrical cleaner
requirements described in Sec. 751.611 must retain records of:
(i) Statement regarding whether the owner or operator is complying
with the prescriptive PPE requirements described in Sec. 751.611(b)(1)
or with the WCPP described in Sec. 751.611(b)(2).
(ii) Dermal and respiratory protection used by each potentially
exposed person and program implementation as described in Sec.
751.611(b)(1) or WCPP records described in Sec. 751.615(b).
(iii) Labels used as described in Sec. 751.611(c).
(iv) Self-certification statements provided as described in Sec.
751.611(d)(1)-(3).
(2) Distributors of PCE, including PCE containing products, for use
in energized electrical cleaning must retain sale records, including:
(i) Name of purchaser;
(ii) Date of sale;
(iii) Quantity of PCE or PCE containing products sold;
(iv) Self-certification statement for each purchase of PCE; and
(v) Copies of labels required in Sec. 751.611(c).
(e) Records related to exemptions. To maintain eligibility for an
exemption described in Sec. 751.617, the records maintained by the
owners or operators must demonstrate compliance with the specific
conditions of the exemption.
(f) 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. 751.617 Exemptions.
(a) General applicability. (1) Time-limited exemptions described in
this section are established in accordance with 15 U.S.C. 2605(g)(1).
(2) To be eligible for the exemptions established in this section,
regulated parties must comply with all conditions promulgated in this
section for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Time-limited exemption for emergency use by the National
Aeronautics and Space Administration. Under 15 U.S.C. 2605(g)(1)(A),
use of PCE or PCE containing products for the conditions of use
identified in paragraph (b)(1) of this section in an emergency by the
National Aeronautics and Space Administration (NASA) and its
contractors operating within the scope of their contracted work is
exempt from the requirements of Sec. 751.605 until December 19, 2034.
(1) Applicability. This exemption shall apply to the following
specific conditions of use:
(i) Industrial and commercial use as solvent for cold cleaning; and
(ii) Industrial and commercial use in wipe cleaning.
(2) Emergency use. (i) An emergency is a serious and sudden
situation requiring immediate action, within 15 days or less, necessary
to protect:
(A) Safety of NASA's or their contractors' personnel;
(B) NASA's missions;
(C) Human health, safety, or property, including that of adjacent
communities; or
(D) The environment.
(ii) Each emergency is a separate situation; if use of PCE exceeds
15 days, then justification must be documented.
(3) Eligibility. To be eligible for the exemption, NASA and its
contractors must:
(i) Select PCE because there are no technically and economically
feasible safer alternatives available during the emergency.
(ii) Perform the emergency use of PCE at locations controlled by
NASA or its contractors.
(iii) Comply with the following conditions:
(A) Within 15 working days of the emergency use by NASA or its
contractors, NASA and its contractors must provide notice to the EPA
Assistant Administrators of both the Office of Enforcement and
Compliance Assurance and the Office of Chemical Safety and Pollution
Prevention that includes the following:
(1) Identification of the conditions of use detailed in paragraph
(b)(1) of this section that the emergency use fell under;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(2)(i) of this section; and
(3) An explanation of why PCE was selected, including why there
were no technically and economically feasible safer alternatives
available in the particular emergency.
(iv) The owner or operator must comply with and document such
compliance efforts under the WCPP provisions in Sec. 751.607, to the
extent technically feasible in light of the particular emergency.
(v) The owner or operator of the location where the use takes place
must
[[Page 103616]]
comply with the recordkeeping requirements in Sec. 751.615.
[FR Doc. 2024-30117 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P