Rule2024-30117
Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 18, 2024
Effective
January 17, 2025
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 243 (Wednesday, December 18, 2024)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30117]
[[Page 103559]]
Vol. 89
Wednesday,
No. 243
December 18, 2024
Part IX
Environmental Protection Agency
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#a2d2c1c78cd6d1c1c3e2c7d2c38cc5cdd4"><span class="__cf_email__" data-cfemail="0676656328727565674663766728616970">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620-1103; telephone number: (202) 554-
1404; email address: <a href="/cdn-cgi/l/email-protection#b2e6e1f1f39ffaddc6dedbdcd7f2d7c2d39cd5ddc4"><span class="__cf_email__" data-cfemail="13474050523e5b7c677f7a7d76537663723d747c65">[email protected]</span></a>.
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:
<bullet> Crude Petroleum Extraction (NAICS code 211120).
<bullet> Support Activities for Oil and Gas Operations (NAICS code
213112).
<bullet> Nonwoven Fabric Mills (NAICS code 313230).
<bullet> Wood Window and Door Manufacturing (NAICS code 321911).
<bullet> Paper Bag and Coated and Treated Paper Manufacturing (NAICS
code 322220).
<bullet> Commercial Screen Printing (NAICS code 323113).
<bullet> Petroleum Refineries (NAICS code 324110).
<bullet> Petroleum Lubricating Oil and Grease Manufacturing (NAICS code
324191).
<bullet> Petrochemical Manufacturing (NAICS code 325110).
<bullet> Industrial Gas Manufacturing (NAICS code 325120).
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180).
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199).
<bullet> Plastics Material and Resin Manufacturing (NAICS code 325211).
<bullet> Synthetic Rubber Manufacturing (NAICS code 325212).
<bullet> Paint and Coating Manufacturing (NAICS code 325510).
<bullet> Adhesive Manufacturing (NAICS code 325520).
<bullet> Soap and Other Detergent Manufacturing (NAICS code 325611).
<bullet> Polish and Other Sanitation Good Manufacturing (NAICS code
325612).
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998).
<bullet> Unlaminated Plastics Film and Sheet (except Packaging)
Manufacturing (NAICS code 326113).
<bullet> All Other Plastics Product Manufacturing (NAICS code 326199).
<bullet> Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220).
<bullet> Rubber Product Manufacturing for Mechanical Use (NAICS code
326291).
<bullet> All Other Rubber Product Manufacturing (NAICS code 326299).
<bullet> Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS
code 327110).
<bullet> Glass Container Manufacturing (NAICS code 327213).
<bullet> Cement Manufacturing (NAICS code 327310).
<bullet> Secondary Smelting, Refining, and Alloying of Nonferrous Metal
(except Copper and Aluminum) (NAICS code 331492).
<bullet> Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119).
<bullet> Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except
Precious) Manufacturing (NAICS code 332215).
<bullet> Saw Blade and Handtool Manufacturing (NAICS code 332216).
<bullet> Other Fabricated Wire Product Manufacturing (NAICS code
332618).
<bullet> Metal Heat Treating (NAICS code 332811).
<bullet> Metal Coating, Engraving (except Jewelry and Silverware), and
Allied Services to Manufacturers (NAICS code 332812).
<bullet> Electroplating, Plating, Polishing, Anodizing, and Coloring
(NAICS code 332813).
<bullet> Industrial Valve Manufacturing (NAICS code 332911).
<bullet> Fluid Power Valve and Hose Fitting Manufacturing (NAICS code
332912).
<bullet> Plumbing Fixture Fitting and Trim Manufacturing (NAICS code
332913).
<bullet> Other Metal Valve and Pipe Fitting Manufacturing (NAICS code
332919).
<bullet> Ball and Roller Bearing Manufacturing (NAICS code 332991).
<bullet> Small Arms Ammunition Manufacturing (NAICS code 332992).
<bullet> Ammunition (except Small Arms) Manufacturing (NAICS code
332993).
<bullet> Small Arms, Ordnance, and Ordnance Accessories Manufacturing
(NAICS code 332994).
<bullet> Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996).
<bullet> All Other Miscellaneous Fabricated Metal Product Manufacturing
(NAICS code 332999).
<bullet> Other Industrial Machinery Manufacturing (NAICS code 333249).
[[Page 103561]]
<bullet> Air-Conditioning and Warm Air Heating Equipment and Commercial
and Industrial Refrigeration Equipment Manufacturing (NAICS code
333415).
<bullet> Machine Tool Manufacturing (NAICS code 333517).
<bullet> Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914).
<bullet> Welding and Soldering Equipment Manufacturing (NAICS code
333992).
<bullet> Packaging Machinery Manufacturing (NAICS code 333993).
<bullet> Industrial Process Furnace and Oven Manufacturing (NAICS code
333994).
<bullet> Fluid Power Cylinder and Actuator Manufacturing (NAICS code
333995).
<bullet> Fluid Power Pump and Motor Manufacturing (NAICS code 333996).
<bullet> All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333999).
<bullet> Instruments and Related Products Manufacturing for Measuring,
Displaying, and Controlling Industrial Process Variables (NAICS code
334513).
<bullet> Analytical Laboratory Instrument Manufacturing (NAICS code
334516).
<bullet> Motor Vehicle Body Manufacturing (NAICS code 336211).
<bullet> Travel Trailer and Camper Manufacturing (NAICS code 336214).
<bullet> Other Motor Vehicle Parts Manufacturing (NAICS code 336390).
<bullet> Aircraft Manufacturing (NAICS code 336411).
<bullet> Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412).
<bullet> Other Aircraft Parts and Auxiliary Equipment Manufacturing
(NAICS code 336413).
<bullet> Guided Missile and Space Vehicle Manufacturing (NAICS code
336414).
<bullet> Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415).
<bullet> Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419).
<bullet> Ship Building and Repairing (NAICS code 336611).
<bullet> Surgical and Medical Instrument Manufacturing (NAICS code
339112).
<bullet> Jewelry and Silverware Manufacturing (NAICS code 339910).
<bullet> Sporting and Athletic Goods Manufacturing (NAICS code 339920).
<bullet> Doll, Toy, and Game Manufacturing (NAICS code 339930).
<bullet> Office Supplies (except Paper) Manufacturing (NAICS code
339940).
<bullet> Gasket, Packing, and Sealing Device Manufacturing (NAICS code
339991).
<bullet> Musical Instrument Manufacturing (NAICS code 339992).
<bullet> Fastener, Button, Needle, and Pin Manufacturing (NAICS code
339993).
<bullet> Broom, Brush, and Mop Manufacturing (NAICS code 339994).
<bullet> Burial Casket Manufacturing (NAICS code 339995).
<bullet> All Other Miscellaneous Manufacturing (NAICS code 339999).
<bullet> Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS code 423120).
<bullet> Home Furnishing Merchant Wholesalers (NAICS code 423220).
<bullet> Industrial Supplies Merchant Wholesalers (NAICS code 423840).
<bullet> Service Establishment Equipment and Supplies Merchant
Wholesalers (NAICS code 423850).
<bullet> Other Miscellaneous Durable Goods Merchant Wholesalers (NAICS
code 423990).
<bullet> Grain and Field Bean Merchant Wholesalers (NAICS code 424510).
<bullet> Other Chemical and Allied Products Merchant Wholesalers (NAICS
code 424690).
<bullet> Petroleum Bulk Stations and Terminals (NAICS code 424710).
<bullet> Petroleum and Petroleum Products Merchant Wholesalers (except
Bulk Stations and Terminals) (NAICS code 424720).
<bullet> New Car Dealers (NAICS code 441110).
<bullet> Used Car Dealers (NAICS code 441120).
<bullet> Other Gasoline Stations (NAICS code 447190).
<bullet> Sporting Goods Stores (NAICS code 451110).
<bullet> All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS code 453998).
<bullet> Scheduled Passenger Air Transportation (NAICS code 481111).
<bullet> Scheduled Freight Air Transportation (NAICS code 481112).
<bullet> Pipeline Transportation of Natural Gas (NAICS code 486210).
<bullet> Teleproduction and Other Postproduction Services (NAICS code
512191).
<bullet> Other Motion Picture and Video Industries (NAICS code 512199).
<bullet> Miscellaneous Intermediation (NAICS code 523910).
<bullet> Other Financial Vehicles (NAICS code 525990).
<bullet> Lessors of Other Real Estate Property (NAICS code 531190).
<bullet> Offices of Real Estate Agents and Brokers (NAICS code 531210).
<bullet> Testing Laboratories (NAICS code 541380).
<bullet> Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715).
<bullet> Marketing Research and Public Opinion Polling (NAICS code
541910).
<bullet> All Other Professional, Scientific, and Technical Services
(NAICS code 541990).
<bullet> Offices of Other Holding Companies (NAICS code 551112).
<bullet> Hazardous Waste Treatment and Disposal (NAICS code 562211).
<bullet> Solid Waste Landfill (NAICS code 562212).
<bullet> Solid Waste Combustors and Incinerators (NAICS code 562213).
<bullet> Other Nonhazardous Waste Treatment and Disposal (NAICS code
562219).
<bullet> Remediation Services (NAICS code 562910).
<bullet> Materials Recovery Facilities (NAICS code 562920).
<bullet> All Other Miscellaneous Waste Management Services (NAICS code
562998).
<bullet> General Automotive Repair (NAICS code 811111).
<bullet> Automotive Exhaust System Repair (NAICS code 811112).
<bullet> Automotive Transmission Repair (NAICS code 811113).
<bullet> Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118).
<bullet> Automotive Body, Paint, and Interior Repair and Maintenance
(NAICS code 811121).
<bullet> Automotive Glass Replacement Shops (NAICS code 811122).
<bullet> Automotive Oil Change and Lubrication Shops (NAICS code
811191).
<bullet> All Other Automotive Repair and Maintenance (NAICS code
811198).
<bullet> Consumer Electronics Repair and Maintenance (NAICS code
811211).
<bullet> Computer and Office Machine Repair and Maintenance (NAICS code
811212).
<bullet> Communication Equipment Repair and Maintenance (NAICS code
811213).
<bullet> Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811219).
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310).
<bullet> Home and Garden Equipment Repair and Maintenance (NAICS code
811411).
<bullet> Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490).
<bullet> Drycleaning and Laundry Services (except Coin-Operated) (NAICS
code 812320).
<bullet> Industrial Launderers (NAICS code 812332).
[[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 (<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>). 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:
<bullet> 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)).
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(section 6(a)(2)).
<bullet> Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(section 6(a)(2)).
<bullet> Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(section 6(a)(3)).
<bullet> Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (section 6(a)(4)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (section 6(a)(5)).
<bullet> Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (section 6(a)(6)).
<bullet> Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (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:
<bullet> Prohibition of most industrial and commercial uses and the
manufacture (including import), processing, and distribution in
commerce, of PCE for those uses;
<bullet> Prohibition of the manufacture (including import),
processing, and distribution in commerce of PCE for all consumer use;
<bullet> 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;
<bullet> 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;
<bullet> Requirements for prescriptive workplace controls for
laboratory use;
<bullet> Establishments of recordkeeping and downstream
notification requirements; and
<bullet> 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:
<bullet> 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;
<bullet> 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
<bullet> 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:
<bullet> Initial exposure monitoring be conducted within 12 months
of publication of the final rule;
<bullet> 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
<bullet> 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:
<bullet> Dates, duration, and results of each sample taken.
<bullet> The quantity, location(s) and manner of PCE use at the
time of each monitoring event.
<bullet> 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.
<bullet> Name, workplace address, work shift, job classification,
work area, and type of respiratory protection (if any) of each
monitored person.
<bullet> Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample.
<bullet> Use of appropriate sampling and analytical methods.
<bullet> 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.
<bullet> Information regarding air monitoring equipment, including:
Type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
<bullet> 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.
<bullet> 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.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is above the ECEL (>0.14 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within three
months of the most recent exposure monitoring.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (>=0.10 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.
<bullet> If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owners or operators must repeat such monitoring within 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.
<bullet> 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
[…truncated; see source link]Indexed from Federal Register on December 18, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.