`[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).

[[Page 103562]]

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.

1. EPA. Risk Evaluation for Perchloroethylene. Document ID No. EPA-
HQ-OPPT-2020-0720-0035. EPA Publication No. 740-R1-8011. December 
2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0058.
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.
4. President Biden. The President and First Lady's Cancer Moonshot: 
Ending Cancer As We Know It. Accessed February 26, 2024. https://www.whitehouse.gov/cancermoonshot/.
5. EPA. Access Chemical Data Reporting Data: 2016 CDR Data (Updated 
May 2020). Document ID No. EPA-HQ-OPPT-2020-0720-0037. Last Updated 
on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
6. EPA. Access Chemical Data Reporting Data: 2020 CDR Data (up-to-
date as of April 2022). Document ID No. EPA-HQ-OPPT-2020-0720-0038. 
Last Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
7. EPA. Regulatory Actions Pertaining to Perchloroethylene. Document 
ID No. EPA-HQ-OPPT-2020-0720-0039. 2022.
8. EPA. Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA); Response to Public Comments. December 
2024.
9. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register. 86 FR 7009, January 20, 2021.
10. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register. 86 FR 7037, January 25, 2021.
11. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
12. EPA. An Alternatives Assessment for Use of Perchloroethylene. 
Document ID No. EPA-HQ-OPPT-2020-0720-0104. RIN 2070-AK84. November 
2022.
13. EPA. Notes from Federalism Consultation on Forthcoming Proposed 
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
Methylpyrrolidone under TSCA Section 6(a). Document ID No. EPA-HQ-
OPPT-2020-0720-0058. July 22, 2021.
14. EPA. Notes from Tribal Consultations on Forthcoming Proposed 
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE). 
Document ID No. EPA-HQ-OPPT-2020-0720-0059. June 15, 2021 and July 
8, 2021.
15. Peter Sinsheimer; Green Analytics. Comments on Environmental 
Justice Consultation for TSCA PCE Risk Management of Dry Cleaning. 
Document ID No. EPA-HQ-OPPT-2020-0720-0060. August 20, 2021.
16. Hans Kim; AQUA Wet Clean. Letter re: Environmental Justice 
Consultation USEPA TSCA PCE Risk Management. Document ID No. EPA-HQ-
OPPT-2020-0720-0061. August 20, 2021.
17. W. Heiger-Bernays and G. Nielsen. Comments on Environmental 
Justice Consultation #2 for TCE and PCE. Document ID No. EPA-HQ-
OPPT-2020-0720-0062. July 5, 2021.
18. Martin Arg[uuml]ello; Physicians for Social Responsibility. 
USEPA EJ Consultation Meeting Comments on PCE and TCE TSCA 
Regulations. Document ID No. EPA-HQ-OPPT-2020-0720-0063. August 20, 
2021.
19. Sa Liu; School of Health Sciences Purdue University. Letter re: 
Environmental Justice Consultation on Forthcoming Proposed 
Rulemakings under TSCA Section 6(a). Document ID No. EPA-HQ-OPPT-
2020-0720-0064. August 20, 2021.
20. EPA. Initial Regulatory Flexibility Analysis for 
Perchloroethylene; Regulation of Perchloroethylene under TSCA Sec.  
6(a) Proposed Rule; RIN 2070-AK84. Document ID No. EPA-HQ-OPPT-2020-
0720-0126. February 2023.
21. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA) 
Section 6(a) Perchloroethylene. Document ID No. EPA-HQ-OPPT-2020-
0720-0066. February 1, 2023.
22. EPA. Final Regulatory Flexibility Analysis (FRFA) for 
Perchloroethylene; Regulation under the Toxic Substances Control Act 
(TSCA). December 2024.
23. EPA. Public Webinar on Perchloroethylene: Risk Evaluation and 
Risk Management under TSCA Section 6. Document ID No. EPA-HQ-OPPT-
2020-0720-0002. January 14, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0002.
24. EPA. Small Business Administration Small Business Environmental 
Roundtable: Risk Evaluation and Risk Management under TSCA Section 6 
for Perchloroethylene. Document ID No. EPA-HQ-OPPT-2020-0720-0004. 
January 15, 2021.
25. EPA. Stakeholder Meeting List for Proposed Rulemaking for 
Perchloroethylene under TSCA Section 6(a). Document ID No. EPA-HQ-
OPPT-2020-0720-0067.
26. EPA. 2021 Policy on Children's Health. Document ID No. EPA-HQ-
OPPT-2020-0720-0068. October 5, 2021.
27. EPA. Public Webinar on Perchloroethylene (PCE) Proposed 
Rulemaking under TSCA Section 6. July 19, 2023.
28. EPA. Stakeholder Meeting List for Proposed and Final Rulemaking 
for Perchloroethylene under TSCA Section 6(a).
29. EPA. Economic Analysis of the Proposed Regulation of 
Perchloroethylene. Document ID No. EPA-HQ-OPPT-2020-0720-0125. 
February 2023.
30. BFK Solutions LLC. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0255. 
August 14, 2023.
31. The Boeing Company. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
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.: 
EPA-HQ-OPPT-2019-0502; EPA-HQ-OPPT-2016-0732; EPA-HQ-OPPT-2020-0720. 
July 15, 2024.
37. Dow Chemical. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0284. 
August 15, 2023.
38. EPA. Meeting with Dow Chemical on Risk Management under TSCA 
Section 6 and Perchloroethylene (PCE). September 26, 2023.
39. The Campus Safety Health and Environmental Management 
Association (CSHEMA). Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0248. 
August 10, 2023.
40. Christopher Kolodziej. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0256. 
August 15, 2023.
41. Purdue University. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0241. July 
21, 2023.
42. Kristi Ohr. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0213. June 
21, 2023.
43. ANSI. ANSI/ASSP Z9.5-2022; Laboratory Ventilation. https://webstore.ansi.org/standards/asse/ansiasspz92022?source=blog&_gl=1*194rqnj*_gcl_au*MjA3NzY5MzI1MS4xNzExMDMzMDEz.
44. ANSI. ANSI/ASHRAE 62.1-2022; Ventilation and Acceptable Indoor 
Air Quality. https://webstore.ansi.org/standards/ashrae/ansiashrae622022.
45. CRC Industries. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0267. 
August 15, 2023.
46. Household and Commercial Products Association. Comments on the 
Proposed Rulemaking for Perchloroethylene (PCE); Regulation Under 
the Toxic Substances Control Act (TSCA). Document ID No. EPA-HQ-
OPPT-2020-0720-0268. August 15, 2023.
47. US Chamber of Commerce. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0279. 
August 15, 2023.
48. American Petroleum Institute. Comments on the Proposed 
Rulemaking for Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-
0720-0282. August 15, 2023.
49. Halogenated Solvents Industry Alliance. Comments on the Proposed 
Rulemaking for Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-
0720-0291. August 15, 2023.
50. National Steering Committee of the State Small Business 
Environmental Assistance Programs. Comments on the Proposed 
Rulemaking for Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-
0720-0265. August 15, 2023.
51. National Fire Protection Association (NFPA). NFPA 70E Standard 
for Electrical Safety in the Workplace. https://www.nfpa.org/codes-and-standards/nfpa-70e-standard-development/70e.
52. EPA. Meeting with CRC Industries on Risk Management under TSCA 
Section 6 and Perchloroethylene (PCE). October 10, 2023.
53. The Chemours Company. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0273. 
August 15, 2023.
54. Honeywell. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0254. 
August 14, 2023.
55. 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-2020-0720-0288. 
August 15, 2023.
56. American Fuel & Petrochemical Manufacturers. Comments on the 
Proposed Rulemaking for Perchloroethylene (PCE); Regulation Under 
the Toxic Substances Control Act (TSCA). Document ID No. EPA-HQ-
OPPT-2020-0720-0277. August 15, 2023.
57. Semiconductor Industry Association. Comments on the Proposed 
Rulemaking for Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-
0720-0271. August 15, 2021.
58. NABTU AFL-CIO, and USW. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0264. 
August 15, 2023.
59. et al. SAFECHEM. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0257. 
August 15, 2023.
60. NIOSH. NIOSH Manual of Analytical Methods (NMAM), 5th Edition, 
Section 2 (February 2020). https://www.cdc.gov/niosh/nmam/pdfs/nmam_5thed_ebook.pdf.
61. Alliance for Automotive Innovation. Comments on the Proposed 
Rulemaking for Perchloroethylene (PCE); Regulation Under the Toxic 
Substances Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-
0720-0274. August 15, 2023.
62. MilliporeSigma. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0247. 
August 10, 2023.
63. National Association of Chemical Distributors (NACD). Comments 
on the Proposed Rulemaking for Perchloroethylene (PCE); Regulation 
Under the Toxic Substances Control Act (TSCA). Document ID No. EPA-
HQ-OPPT-2020-0720-0237. July 17, 2023.
64. AIHA. Comments on the Proposed Rulemaking for Perchloroethylene 
(PCE); Regulation Under the Toxic Substances Control Act (TSCA). 
Document ID No. EPA-HQ-OPPT-2020-0720-0240. July 19, 2023.
65. Earthjustice et al. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0289. 
August 15, 2023.
66. Environmental Defense Fund. Comments on the Proposed Rulemaking 
for Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0280. 
August 15, 2023.
67. EPA. Perchloroethylene (PCE): Risk Management Support Documents. 
Document ID No. EPA-HQ-OPPT-2020-0720-0076. November 18, 2022.
68. Jean Warshaw. Comments on the Proposed Rulemaking for 
Perchloroethylene (PCE); Regulation Under the Toxic Substances 
Control Act (TSCA). Document ID No. EPA-HQ-OPPT-2020-0720-0285. 
August 15, 2023.
69. OSHA. OSHA 1999 Multi-Employer Citation Policy. Accessed 10/27/
2023. https://www.osha.gov/enforcement/directives/cpl-02-00-124.
70. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane. 
Document ID No.

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EPA-HQ-OPPT-2020-0720-0071. EPA Publication No. EPA-740-R-20-005. 
August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0427-0048.
71. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational 
Use of Perchloroethylene. Document ID No. EPA-HQ-OPPT-2020-0720-
0043. April 15, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0023.
72. OSHA. Final Rule. Occupational Exposure to Methylene Chloride. 
Document ID No. EPA-HQ-OPPT-2020-0720-0073. Federal Register. 62 FR 
1494, January 10, 1997.
73. OSHA. OSHA Technical Manual (OTM) Section II: Chapter 1. 
Personal Sampling for Air Contaminants. Last updated on September 
14, 2023. https://www.osha.gov/otm/section-2-health-hazards/chapter-1.
74. OSHA. Letter from OSHA. June 5, 2024.
75. NIOSH. Letter from NIOSH. June 28, 2024.
76. NIOSH. Hierarchy of Controls. Document ID No. EPA-HQ-OPPT-2020-
0720-0042. Page last reviewed: August 11, 2022. https://www.cdc.gov/niosh/topics/hierarchy/.
77. OSHA. Personal Protective Equipment. Document ID No. EPA-HQ-
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`