[Federal Register Volume 89, Number 90 (Wednesday, May 8, 2024)]
[Rules and Regulations]
[Pages 39254-39302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09606]
[[Page 39253]]
Vol. 89
Wednesday,
No. 90
May 8, 2024
Part V
Environmental Protection Agency
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40 CFR Part 751
Methylene Chloride; Regulation Under the Toxic Substances Control Act
(TSCA); Final Rule
Federal Register / Vol. 89 , No. 90 / Wednesday, May 8, 2024 / Rules
and Regulations
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0465; FRL-8155-01-OCSPP]
RIN 2070-AK70
Methylene Chloride; Regulation Under the Toxic Substances Control
Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
finalizing a rule to address the unreasonable risk of injury to health
presented by methylene chloride 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 and death 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 an
industrial and commercial use of the chemical is being prohibited,
provide a time-limited exemption for a critical or essential use of
methylene chloride for which no technically and economically feasible
safer alternative is available, and protect workers from the
unreasonable risk of methylene chloride while on the job.
DATES: This final rule is effective on July 8, 2024.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OPPT-2020-0465. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available
electronically through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Ingrid Feustel, 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) 564-3199; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this rule if you manufacture
(defined under TSCA to include import), process, distribute in
commerce, use, or dispose of methylene chloride or products containing
methylene chloride. 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 methylene chloride are subject to any
provisions regulating manufacture of methylene chloride. The following
list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Potentially
affected entities include:
Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690);
Crude Petroleum Extraction (NAICS code 211120);
All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690);
Petroleum Bulk Stations and Terminals (NAICS code 424710);
Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
Testing Laboratories (NAICS code 541380);
Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology (NAICS code
541715);
Hazardous Waste Treatment and Disposal (NAICS code
562211);
Solid Waste Combustors and Incinerators (NAICS code
562213);
Materials Recovery Facilities (NAICS code 562920);
Paint and Coating Manufacturing (NAICS code 325510);
Air and Gas Compressor Manufacturing (NAICS code 333912);
Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991);
Residential Remodelers (NAICS code 236118);
Commercial and Institutional Building Construction (NAICS
code 236220);
Plumbing, Heating, and Air-Conditioning Contractors (NAICS
code 238220);
Painting and Wall Covering Contractors (NAICS code
238320);
All Other Miscellaneous Manufacturing (NAICS code 339999);
Automotive Parts and Accessories Stores (NAICS code
441310);
All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS code 453998);
Other Support Activities for Air Transportation (NAICS
code 488190);
All Other Automotive Repair and Maintenance (NAICS code
811198);
Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
Footwear and Leather Goods Repair (NAICS code 811430);
Adhesive Manufacturing (NAICS code 325520);
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
Audio and Video Equipment Manufacturing (NAICS code
334310);
Reupholstery and Furniture Repair (NAICS code 811420);
All Other Rubber Product Manufacturing (NAICS code
326299);
All Other Miscellaneous Textile Product Mills (NAICS code
314999);
All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999);
Oil and Gas Field Machinery and Equipment Manufacturing
(NAICS code 333132);
Bare Printed Circuit Board Manufacturing (NAICS code
334412);
Other Electronic Component Manufacturing (NAICS code
334419);
All Other Miscellaneous Electrical Equipment and Component
Manufacturing (NAICS code 335999);
Printing Machinery and Equipment Manufacturing (NAICS code
333244);
Petroleum Refineries (NAICS code 324110);
Petroleum Lubricating Oil and Grease Manufacturing (NAICS
code 324191);
Painting and Wall Covering Contractors (NAICS code
238320);
Welding and Soldering Equipment Manufacturing (NAICS code
333992);
New Car Dealers (NAICS code 441110);
Used Car Dealers (NAICS code 441120);
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Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320); and
Doll, Toy, and Game Manufacturing (NAICS code 339930).
This action may also affect certain entities through pre-existing
import, including import certification, and export notification rules
under TSCA. 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
also subject to TSCA section 13 import certification requirements and
the corresponding regulations at 19 CFR 12.118 through 12.127; see also
19 CFR 127.28. Those persons must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA. The EPA policy in support of import certification appears at 40
CFR part 707, subpart B. In addition, any persons who export or intend
to export a chemical substance that is the subject of this 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 methylene chloride 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 EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in 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 methylene
chloride presents an unreasonable risk of injury to health, without
consideration of costs or other non-risk factors, including an
unreasonable risk to potentially exposed or susceptible subpopulations
identified as relevant to the 2020 Risk Evaluation for Methylene
Chloride by EPA, under the conditions of use (Refs. 1, 2). A detailed
description of the conditions of use that contribute to EPA's
determination that methylene chloride presents an unreasonable risk is
in Unit II.C.4. Accordingly, to address the unreasonable risk, EPA is
issuing this final rule under TSCA section 6(a) to:
(i) Prohibit the manufacture, processing, and distribution of
methylene chloride for all consumer use, as outlined in Unit IV.C.;
(ii) Prohibit most industrial and commercial use of methylene
chloride and delay prohibition for two conditions of use, as outlined
in Unit IV.C.;
(iii) Require a workplace chemical protection program (WCPP),
including inhalation exposure concentration limits and related
workplace exposure monitoring and exposure controls, for 13 conditions
of use of methylene chloride (including manufacture; processing;
several industrial and commercial uses such as laboratory use; and
disposal), as outlined in Unit IV.B.;
(iv) Identify a de minimis threshold for products containing
methylene chloride for the prohibitions and restrictions on methylene
chloride, as outlined in Unit IV.A.;
(v) Require recordkeeping and downstream notification requirements
for manufacturing, processing, and distribution in commerce of
methylene chloride, as outlined in Unit IV.E.; and
(vi) Provide a 10-year time-limited exemption under TSCA section
6(g) for emergency use of methylene chloride in furtherance of the
National Aeronautics and Space Administration's mission for specific
conditions which are critical or essential and for which no technically
and economically feasible safer alternative is available, taking into
consideration hazard and exposure, as outlined in Unit IV.F., with
conditions for this exemption to include compliance with the WCPP
described in Unit IV.B.
EPA notes that all TSCA conditions of use of methylene chloride
(other than the use of methylene chloride in consumer paint and coating
removers, which was subject to separate action under TSCA section 6 (84
FR 11420, March 27, 2019) (FRL-9989-29) are subject to this final rule.
Condition 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 provisions of 40 CFR part
751, subpart A, to define ``Article,'' ``Authorized person,'' ``Owner
or operator,'' ``Potentially exposed person,'' ``Product,'' ``Regulated
area,'' and ``Retailer'' so that these definitions may be commonly
applied to this and other rules under TSCA section 6 that would be
codified under 40 CFR part 751.
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 no longer presents such risk.''
Methylene chloride was the subject of a risk evaluation under TSCA
section 6(b)(4)(A) that was issued in June 2020 (Ref. 1). In addition,
EPA issued a revised unreasonable risk determination for methylene
chloride in November 2022 (Ref. 2) determining that methylene chloride,
as a whole chemical substance, presents an unreasonable risk of injury
to health under the conditions of use. On May 3, 2023, EPA issued a
proposed rule (88 FR 28284) (FRL-8155-02-OCSPP) under TSCA section 6(a)
to regulate methylene chloride, so that it no longer presents
unreasonable risk. The Agency received public comment on the proposal.
With this action, EPA is finalizing with modifications the May 2023
proposed rule so that methylene chloride no longer presents an
unreasonable risk. The conditions of use that contribute to the
unreasonable risk from methylene chloride are described in Unit
III.B.1. of the proposed rule (88 FR 28284) (FRL-8155-02-OCSPP).
EPA emphasizes that some of the adverse effects from methylene
chloride exposure, including sudden death, can be both immediately
experienced and after only a short duration (Ref. 1). Other effects may
result in long-term human health impacts which are also considered
significant, including liver effects and cancer. Fatalities from acute
methylene chloride exposures have been documented and pose a serious
public health threat; these fatalities led the agency to prohibit the
manufacture, processing, and distribution of methylene chloride for use
in consumer paint and coating removers in 2019 (84 FR 11420, March 27,
2019) (FRL-9989-29). This final rule will eliminate the unreasonable
risk to human health from the remaining conditions of use of methylene
chloride, as identified in the 2020 Risk Evaluation for Methylene
Chloride (Ref. 1) and the Revised Unreasonable Risk Determination for
Methylene Chloride in November 2022 (Ref. 2).
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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
methylene chloride. While addressing the unreasonable risk, this final
rule allows methylene chloride's limited and controlled continued use
in tandem with additional worker protections for several purposes,
including the production of hydrofluorocarbon-32 (HFC-32), one of the
regulated substances that are subject to a phasedown under the American
Innovation and Manufacturing (AIM) Act of 2020. 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, Small Business Advocacy Review (SBAR) Panel process, the
comment period following publication of the proposed rule, or during
stakeholder outreach, and are available in the corresponding public
dockets (EPA-HQ-OPPT-2020-0465; EPA-HQ-OPPT-2019-0437; EPA-HQ-OPPT-
2016-0742).
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), EPA's analysis of the incremental, non-closure-
related costs of this rule is estimated to be $37.0 million annualized
over 20 years at a 3% discount rate and $39.5 million annualized over
20 years at a 7% discount rate. In response to the updated Circular A-4
published in November 2023, the incremental, non-closure related costs
of this rule at a 2% discount rate ($36.4 million annualized over 20
years) is provided in appendix D of the Economic Analysis (Ref. 3).
These costs take compliance with implementation of a WCPP for certain
conditions of use into consideration, which would include an Existing
Chemical Exposure Limit (ECEL) of 2 ppm (8 mg/m\3\) for inhalation
exposures as an 8-hour time-weighted average (TWA), applicable personal
protective equipment (PPE) requirements, and reformulation costs of
numerous products.
In alignment with the goals of President Biden's Cancer Moonshot,
the rule will protect people from cancer and other adverse health
effects of methylene chloride by prohibiting most uses of methylene
chloride 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. Although
some benefits cannot be quantified, they are not necessarily less
important than the quantified benefits. The incremental improvements in
health outcomes achieved by given reductions in exposure cannot be
quantified for non-cancer health effects associated with methylene
chloride exposure, and therefore cannot be converted into monetized
benefits.
The monetized benefits of this rule are approximately $24.8 million
to $25.1 million annualized over 20 years at a 3% discount rate and
$19.8 million to $20.0 million annualized over 20 years at a 7%
discount rate. In response to the updated Circular A-4 published in
November 2023, the incremental benefits at a 2% discount rate ($27.1 to
$27.5 million annualized over 20 years) are provided in appendix D of
the Economic Analysis (Ref. 3). The monetized benefits only include
potential reductions in risk of liver cancer and lung cancer associated
with chronic exposures, and potential deaths avoided from acute
methylene chloride exposure. Non-monetized benefits include potential
reductions in central nervous system depressant effects; these effects
include loss of consciousness and respiratory depression that may
result in irreversible coma and hypoxia. Risks from acute exposures to
methylene chloride can lead to workplace accidents and are precursors
to the more severe central nervous system effects (up to and including
death). Other non-monetized benefits include reductions in liver
disease (including vacuolization, necrosis, hemosiderosis and
hepatocellular degeneration), immune system compromise, and irritation
and burns (Ref. 3).
II. Background
A. Overview of Methylene Chloride
As described in more detail in the May 2023 proposed rule (88 FR
28284, May 3, 2023) (FRL-8155-02-OCSPP), methylene chloride is acutely
lethal, a neurotoxicant, and a carcinogen. This final rule is
specifically intended to address the unreasonable risk of injury to
health that EPA has identified in the 2020 Risk Evaluation for
methylene chloride (Ref. 1) and 2022 Revised Unreasonable Risk
Determination (Ref. 2), as described in Unit II.C.3. Methylene chloride
is a colorless liquid and a volatile chemical with a sweet odor
resembling chloroform. It is both produced in and imported into the
United States. Methylene chloride is manufactured, processed,
distributed in commerce, used, and disposed of as part of many
industrial, commercial, and consumer conditions of use. As outlined in
Unit II.C.4., methylene chloride is a widely used solvent in a variety
of consumer and commercial applications including adhesives and
sealants, automotive products, and paint and coating removers. Some
evidence suggests that in recent years, use of methylene chloride has
been declining in certain sectors (Ref. 3), particularly for consumer
products, as the hazards of methylene chloride are well known, and
certain uses are highly regulated. As further described in Unit II.B.
and in the regulatory appendix (Ref. 5), these regulations include
EPA's 2019 final rule addressing unreasonable risk to consumers from
methylene chloride use in consumer paint and coating removal by
prohibiting manufacturing, processing, and distribution in commerce of
methylene chloride for consumer use in paint and coating removal (84 FR
11420, March 27, 2019) (FRL-9989-29).
The total annual aggregate production volume of methylene chloride
was between 100 million to 500 million pounds between 2016 and 2019
according to Chemical Data Reporting (CDR) (Ref. 6). One notable high-
volume use accounting for approximately one-fifth of all methylene
chloride annual production volume is processing as a reactant, which
includes the manufacture of HFCs (Ref. 1). This condition of use is
described in Unit II.B.1. of the proposed rule, with a description of
final requirements to address unreasonable risk in Units II.D.1. and
IV. An estimated 35% of the annual production volume of methylene
chloride is for pharmaceutical uses, which are not subject to TSCA and
will not be regulated by this rule (15 U.S.C. 2602(2)(B)(vi); 21 U.S.C.
321(g)(1)).
B. Regulatory Actions Pertaining to Methylene Chloride
Because of its adverse health effects, methylene chloride is
subject to numerous State, Federal, and international regulations
restricting and regulating its use. A summary of EPA regulations
pertaining to methylene chloride, as well as other Federal, State, and
international regulations, is in the docket (Refs. 1, 5).
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As described in more detail in EPA's proposed rule (88 FR 28284,
May 3, 2023) (FRL-8155-02-OCSPP), and the Response to Public Comments
document (Ref. 7), EPA considered the adequacy of the current standard
for methylene chloride from the Occupational Safety and Health
Administration (OSHA) (29 CFR 1910.1052) 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 standards that EPA
promulgates under TSCA section 6(a). The control measures OSHA and EPA
require to satisfy the objectives of their respective statutes may
also, in many circumstances, overlap or coincide. However, 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.
Additional considerations of OSHA standards in the revised unreasonable
risk determination are discussed further in the 2022 Revised
Unreasonable Risk Determination for Methylene Chloride, published in
the Federal Register of November 10, 2022 (87 FR 67901) (Ref. 2).
EPA intends for this regulation to be as consistent as possible
with the current OSHA standard for methylene chloride, with additional
requirements as necessary to address the unreasonable risk. 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 Methylene Chloride
In July 2017, EPA published the scope of the methylene chloride
risk evaluation (82 FR 31592, July 7, 2017) (FRL-9963-57), and, after
receiving public comments, published the problem formulation in June
2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In October 2019, EPA
published a draft risk evaluation (84 FR 57866, October 29, 2019) (FRL-
9999-69), and, after public comment and peer review by the Science
Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk
Evaluation for Methylene Chloride in June 2020 in accordance with TSCA
section 6(b) (85 FR 37942, June 24, 2020) (FRL-10011-16). EPA
subsequently issued a draft revised TSCA risk determination for
methylene chloride (87 FR 39824, July 5, 2022) (9946-01-OCSPP), and,
after public notice and receipt of comments, published a Revised Risk
Determination for Methylene Chloride in November 2022 (Ref. 2). The
2020 Risk Evaluation for Methylene Chloride and supplemental materials
are in docket EPA-HQ-OPPT-2019-0437, and the November 2022 revised
unreasonable risk determination and additional materials supporting the
risk evaluation process are in docket EPA-HQ-OPPT-2016-0742, on https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for Methylene Chloride, EPA evaluated
risks associated with 53 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 proposed rule. The 2020 Risk Evaluation for Methylene Chloride
identified significant adverse health effects associated with short-
and long-term exposure to methylene chloride. A further discussion of
the hazards of methylene chloride is in Unit III.B.1. of the proposed
rule (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP).
2. 2022 Revised Unreasonable Risk Determination
As described in more detail in EPA's proposed rule (88 FR 28284,
May 3, 2023) (FRL-8155-02-OCSPP), EPA revised the original unreasonable
risk determination based on the 2020 Risk Evaluation for Methylene
Chloride and issued a final revised unreasonable risk determination in
November 2022 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for Methylene Chloride pursuant to TSCA section 6(b)
and consistent with Executive Order 13990, (``Protecting Public Health
and the Environment and Restoring Science to Tackle the Climate
Crisis'') and other Administration priorities (Refs. 8, 9, 10). The
revisions consisted of making the risk determination based on the
whole-chemical substance instead of making risk determinations 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 methylene chloride presents an unreasonable
risk of injury to health, and did not identify risks of injury to the
environment that contribute to the unreasonable risk determination for
methylene chloride. The methylene chloride conditions of use that drive
EPA's determination that the chemical substance poses unreasonable risk
to health are listed in the unreasonable risk determination (Ref. 2)
and also in Unit III.B.2. of the 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 methylene chloride 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 EPA's proposed rule (88 FR 28284, May 3, 2023) (FRL-
8155-02-OCSPP) and as described in the TSCA section 6(b) 2020 Risk
Evaluation for Methylene Chloride, EPA identified non-cancer adverse
effects from both acute and chronic inhalation and dermal exposures to
methylene chloride, and cancer from chronic inhalation and dermal
exposures to methylene chloride (Ref. 1). EPA identified neurotoxicity
effects (central nervous system) as the most sensitive endpoint of the
non-cancer adverse effects from acute inhalation and dermal exposures,
and liver effects as the most sensitive endpoint of the non-cancer
adverse effects from chronic inhalation and dermal exposures for all
conditions of use. EPA identified additional risks associated with
other adverse effects (e.g., other nervous system effects, immune
system effects, reproductive and developmental effects, and irritation/
burns) resulting from acute and chronic exposures. By targeting the
sensitive chronic liver 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 methylene chloride. EPA
also recognizes the severity of the risks from acute inhalation
exposures to methylene chloride, because relatively small increases in
acute exposure can lead to extreme adverse effects
[[Page 39258]]
associated with central nervous system suppression, including coma and
death. Occupational fatalities linked to methylene chloride have been
recorded as recently as June 2020 (Ref. 11) and, most recently by OSHA,
in March 2021 and July 2023 (Ref. 12). Eighty-five (85) fatalities
between 1980 and 2018 have been documented from methylene chloride in
paint and coating removal or adhesive and sealant use, and when
methylene chloride is being used as a cleaning or degreasing solvent,
74 of which were in occupational settings; there has been no linear
trend indicating a decrease in fatalities during that time period (Ref.
11). In some instances, while trained workers were wearing respirators,
the respirators were inadequate to protect against methylene chloride
inhalation exposure (Ref. 11).
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 Methylene Chloride (Ref. 1) and were
considered in the determination of unreasonable risk for methylene
chloride.
4. Conditions of Use Subject to This Regulatory Action
Conditions of use is defined in TSCA section 3(4) to mean the
circumstances under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of. Conditions of use descriptions are
provided in Unit III.B.1. of the proposed rule (88 FR 28284, May 3,
2023) (FRL-8155-02-OCSPP) and were obtained from EPA sources such as
CDR use codes, the 2020 Risk Evaluation for Methylene Chloride and
related documents, as well as the Organisation for Economic Co-
operation and Development harmonized use codes, and stakeholder
engagements. EPA did not receive public comments identifying
inaccuracies or necessitating changes to those descriptions; however,
EPA received some comments requesting clarification for particular
uses, which can be found in the response to comments document (Ref. 7).
Additionally, to assist with implementation and compliance with the
final rule, in Unit IV.B.1., EPA has provided a description of the
conditions of use that are subject to the WCPP.
As in the 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 proposed rule.
Although EPA identified both industrial and commercial uses in the 2020
Risk Evaluation for Methylene Chloride (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 manner or method of commercial use'' under TSCA
section 6(a)(5) to reach both industrial and commercial uses.
Additionally, as described in the proposed rule (88 FR 28284, May
3, 2023) (FRL-8155-02-OCSPP), in the 2020 Risk Evaluation for Methylene
Chloride (Ref. 1), EPA identified and assessed all known, intended, and
reasonably foreseen industrial, commercial, and consumer uses of
methylene chloride (other than the use of methylene chloride in
consumer paint and coating removers, which was subject to separate
action under TSCA section 6 (84 FR 11420, March 27, 2019) (FRL-9989-
29). EPA determined that all industrial, commercial, and consumer use
of methylene chloride evaluated in the 2020 Risk Evaluation for
Methylene Chloride 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 methylene
chloride consumer uses. Likewise, for the purpose of this risk
management rule, ``industrial and commercial use'' refers to all known,
intended, or reasonably foreseen methylene chloride industrial and
commercial use.
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)(i) 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 Methylene Chloride
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 or in combination:
Prohibit or otherwise restrict the manufacturing
(including import), processing, or distribution in commerce of the
substance or mixture, or limit the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce
(section 6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(section 6(a)(2)).
Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (section 6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (section 6(a)(7)).
In the 2023 proposed rule for methylene chloride under TSCA section
6(a) (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP), EPA analyzed how
[[Page 39259]]
the TSCA section 6(a) requirements could be applied to address the
unreasonable risk from methylene chloride so that it no longer presents
such risk. Unit II.D.1., summarizes the TSCA section 6 considerations
for issuing regulations under TSCA section 6(a). Unit V. outlines how
EPA applied these considerations while managing the unreasonable risk
from methylene chloride.
As required, EPA developed a proposed regulatory action and one
primary alternative regulatory action, which are described in Units
IV.A. and IV.B., respectively, of the 2023 proposed rule for methylene
chloride (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP). 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
methylene chloride at different levels in the supply chain to eliminate
exposures or restrict the availability of methylene chloride and
methylene chloride-containing products for consumer use in order to
address the unreasonable risk.
As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) regulatory requirements for the
proposed rule. EPA's considerations regarding TSCA section 6(c)(2) and
section 6(c)(2)(A) for methylene chloride are discussed in full in Unit
VI. of the proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-
OCSPP), including the statement of effects with respect to these
considerations. After review of the public comments received, EPA has
revised its statement of effects considerations in Unit V. of this
final rule.
As described in more detail in EPA's proposed rule (88 FR 28284,
May 3, 2023) (FRL-8155-02-OCSPP), EPA also considered regulatory
authorities under statutes administered by other agencies such as the
OSH Act, the Consumer Product Safety Act (CPSA), and the Federal
Hazardous Substances Act (FHSA), as well as other EPA-administered
statutes, to examine 1) Whether there are opportunities to address
unreasonable risk under other statutes, such that a referral may be
warranted under TSCA section 9(a) or 9(b); or 2) Whether TSCA section
6(a) regulation could include alignment of requirements and definitions
in and under existing statutes and regulations to minimize confusion to
the regulated entities and the general public.
Additionally, as described in more detail in EPA's proposed rule in
Unit V.B. (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP), EPA
considered the availability of alternatives when finalizing a
prohibition or a substantial restriction (TSCA section 6(c)(2)(C))
(Ref. 13), and in setting final compliance dates in accordance with the
requirements in TSCA section 6(d)(1)(B)).
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 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 Methylene Chloride (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 primary alternative action described in this
unit. Additional details related to how the requirements in this unit
were incorporated into development of the proposed rule and primary
alternative action are in Unit V. of the proposed rule.
2. Consultations and Other Engagement
a. Consultations
EPA conducted consultations and outreach as part of development of
the May 2023 proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-
OCSPP). The Agency held a federalism consultation from October 22,
2020, until January 23, 2021, as part of the rulemaking process and
pursuant to Executive Order 13132. (Ref. 14).
EPA also consulted with tribal officials during the development of
the May 2023 proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-
OCSPP) (Ref. 15). The Agency held a tribal consultation from October 7,
2020, to January 8, 2021, with meetings on November 12 and 13, 2020.
(Ref. 15). EPA received no written comments as part of this
consultation.
EPA's Environmental Justice (EJ) consultation occurred from
November 4, 2020, through January 18, 2021. On November 16 through 19,
2020, EPA held public meetings as part of this consultation. These
meetings were held pursuant to Executive Orders 12898 and 14008. EPA
received three written comments following the EJ meetings, in addition
to oral comments provided during the consultations (Refs. 16, 17,18).
The proposed rule presents a brief summary of the comments in Unit
III.A.1. of that document (88 FR 28284, May 3, 2023) (FRL-8155-02-
OCSPP).
As required by section 609(b) of the Regulatory Flexibility Act
(RFA), EPA convened a 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 November 4, 2020, and January 28, 2021. Panel
recommendations were addressed in Unit X.C. of the proposed rule and in
the Initial Regulatory Flexibility Analysis (IRFA) (Ref. 19); the Panel
report is in the docket (Ref. 20). EPA has also prepared a Final
Regulatory Flexibility Analysis (FRFA) (Ref. 21).
The May 2023 proposed rule presents more information regarding the
consultations in Units III.A.1., X.C., X.E., X.F. and X.J. of that
document (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP).
b. Other Stakeholder Consultations
For development of the proposed rule, in addition to the formal
consultations described in Unit X. of the proposed rule, EPA provided
an overview of the TSCA risk management process and the findings in the
2020 Risk Evaluation for Methylene Chloride (Refs. 22, 23) during a
Small Business Administration (SBA) Office of Advocacy Environmental
Roundtable on September 11, 2020, and in a public webinar on September
16, 2020. Attendees of these meetings were given an opportunity to
voice their concerns regarding the risk evaluation and risk management.
Furthermore, during development of the proposed rule, EPA engaged
in discussions with representatives from different industries, non-
governmental organizations, technical experts, organized labor, and
users of methylene chloride. A list of external meetings held during
the development of the May 2023 proposed rule is in the docket (Ref.
[[Page 39260]]
24); meeting materials and summaries are also in the docket. A summary
of the topics discussed during the meetings is in Unit III.A.2. of the
proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP).
c. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 25) requires
EPA to protect children from environmental exposures by consistently
and explicitly considering early life exposures (from conception,
infancy, and 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 so that methylene chloride no longer presents an
unreasonable risk (which includes unreasonable risk to any relevant
potentially exposed or susceptible subpopulations). Information on how
the 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 the 2020 Risk Evaluation for Methylene Chloride, and the
Economic Analysis for this rule (Refs. 1, 3).
3. Proposed Regulatory Action
EPA's proposed rule under TSCA section 6(a) to address the
unreasonable risk presented by methylene chloride under its conditions
of use (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP) included the
following:
(i) Prohibition of the manufacture, processing, and distribution of
methylene chloride for all consumer use;
(ii) Prohibition of most industrial and commercial use of methylene
chloride;
(iii) Requirements for a WCPP, including inhalation exposure
concentration limits and related workplace exposure monitoring and
exposure controls, for ten conditions of use of methylene chloride
(including manufacture; processing as a reactant; laboratory use;
industrial or commercial use in aerospace and military paint and
coating removal from safety-critical, corrosion-sensitive components by
Federal agencies and their contractors; industrial or commercial use as
a bonding agent for acrylic and polycarbonate in mission-critical
military and space vehicle applications, including in the production of
specialty batteries for such by Federal agencies and their contractors;
and disposal);
(iv) Requirements for recordkeeping and downstream notification
requirements for manufacturing, processing, and distribution in
commerce of methylene chloride;
(v) A 10-year time-limited exemption under TSCA section 6(g) for
civilian aviation from the prohibition addressing the use of methylene
chloride for paint and coating removal to avoid significant disruptions
to critical infrastructure, with conditions for this exemption to
include compliance with the WCPP; and
(vi) A 10-year time-limited exemption under TSCA section 6(g) for
emergency use of methylene chloride in furtherance of the National
Aeronautics and Space Administration's mission for specific conditions
which are critical or essential and for which no technically and
economically feasible safer alternative is available, with conditions
for this exemption to include compliance with the WCPP.
EPA notes that all TSCA conditions of use of methylene chloride
(other than the use of methylene chloride in consumer paint and coating
removers, which was subject to separate action under TSCA section 6 (84
FR 11420, March 27, 2019) (FRL-9989-29) were subject to the May 2023
proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP) and are
subject to this final rule.
The proposed rule included timeframes for implementation. The
prohibitions EPA proposed would take effect in phases, beginning at the
top of the supply chain, and coming into full effect after 450 days, as
described in Units IV.A.2. and 3. of the proposal. Likewise, for the
WCPP, EPA proposed timeframes for phases of compliance, beginning with
monitoring at 180 days and full implementation after 360 days, as
described in Unit IV.A.1. of the proposed rule.
Under TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA is
mandated to consider and propose an alternative regulatory action. This
was included in the proposed rule in Unit IV.B. (88 FR 28284, May 3,
2023) (FRL-8155-02-OCSPP). Similar to the proposed regulatory action,
it combined prohibitions and requirements for a WCPP to address the
unreasonable risk from methylene chloride under its conditions of use,
as well as time-limited exemptions under TSCA section 6(g) for two
uses. More specifically, the alternative regulatory action would allow
for the WCPP, including requirements to meet an ECEL and EPA Short-Term
Exposure Limit (STEL), for several additional conditions of use than
would have been allowed under the proposed regulatory action. The
alternative regulatory action additionally included longer compliance
timeframes for prohibitions and a WCPP.
The alternative regulatory action considered would have allowed a
WCPP for the following additional industrial and commercial conditions
of use: industrial and commercial use in finishing products for fabric,
textiles, and leather; industrial and commercial use as solvent that
becomes part of a formulation or mixture; industrial and commercial use
as a processing aid; industrial and commercial use for electrical
equipment, appliance, and component manufacturing; industrial and
commercial use for plastic and rubber products manufacturing;
industrial and commercial use in cellulose triacetate film production;
industrial and commercial use for oil and gas drilling, extraction, and
support activities; and industrial and commercial use in paint or
coating removal from safety-critical, corrosion-sensitive components of
aircraft owned or operated by air carriers or commercial operators
certificated under 14 CFR part 119. At the time of publication of the
proposed rule for methylene chloride, EPA believed a WCPP had the
potential to be a viable alternative to the proposed prohibition for
these additional industrial and commercial conditions of use because
these were generally industrial in nature; owners or operators were
likely currently complying with the OSHA methylene chloride standard;
and, as far as the Agency was aware, these conditions of use had not
resulted in any documented fatalities. However, at the time of
proposal, EPA did not have reasonably available information that could
confirm that compliance with an ECEL of 2 ppm was possible (e.g.,
monitoring data or detailed description of activities involving
methylene chloride for these conditions of use). Therefore, EPA
preliminarily proposed that these conditions of use be prohibited.
The alternative regulatory action also included longer timeframes
for implementation of both the prohibitions and WCPP. Those timeframes
are described in Unit IV.B. of the proposed rule, respectively (88 FR
28284, May 3, 2023) (FRL-8155-02-OCSPP).
[[Page 39261]]
For a comprehensive overview of the alternative regulatory action,
refer to Unit IV.B. of the proposed rule, with the rationale for the
primary alternative regulatory action provided in Unit V.B. of the
proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP).
4. Public Comments Received
EPA requested comment on all aspects of the proposed rule (88 FR
28284, May 3, 2023) (FRL-8155-02-OCSPP) which published on May 3, 2023.
The comment period closed on July 3, 2023. EPA received almost 40,000
public comments, with a vast majority received from individuals
participating in mass mailer campaigns organized by non-governmental
organizations. The public comments also include approximately 200
unique comments from industry stakeholders, trade associations,
environmental groups, unions, non-governmental health advocacy
organizations, academics, State and local governments, 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. 7). 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 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 methylene chloride. 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 (EPA-HQ-OPPT-2020-0465) (Ref. 24).
After review of the public comments received from the proposed rule
(88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP) for methylene chloride,
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 (Ref. 7). 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
This unit summarizes the main changes from the proposed rule to the
final rule, based on the consideration of the public comments.
A. Changes to Conditions of Use Allowed To Continue Under WCPP
EPA's primary alternative regulatory action described in the
proposed rule included several conditions of use under the WCPP, rather
than prohibition. As described in Units III.A.1. through 5., EPA's
final rule allows three additional conditions of use under the WCPP
(Units III.A.1. through III.A.3.) and broadens the scope of two
conditions of use allowed to continue under the WCPP, when compared to
the proposed rule. The rationale for these changes is described in this
unit and EPA notes that in the event that sensitive information
relating to national security or critical infrastructure is submitted
to EPA, the Agency will protect such information in accordance with
applicable authorities. EPA's final rule also clarifies that this rule
permits manufacturing and processing in compliance with the WCPP for
export. More information is provided in Unit IV.A. regarding export.
EPA emphasizes that implementation of the WCPP can fully address
the unreasonable risk from methylene chloride for the conditions of use
allowed to continue, and that these changes do not significantly impact
the production volume of methylene chloride expected to remain in
commerce when compared to the proposed regulatory action. Taken
together, the conditions of use described in Units III.A.1. through 5.
account for less than an estimated 2% of the total production volume of
methylene chloride.
1. Industrial and Commercial Use of Methylene Chloride as a Processing
Aid
EPA is finalizing a WCPP for industrial and commercial use of
methylene chloride as a processing aid, as included in the primary
alternative regulatory action of EPA's proposal (88 FR 28284, May 3,
2023) (FRL-8155-02-OCSPP). While EPA proposed to prohibit industrial
and commercial use of methylene chloride as a processing aid, this was
due to insufficient information at the time of proposal to determine
that the sector as a whole could comply with a WCPP. During the Small
Business Advocacy Review Panel, EPA received data from a small business
using methylene chloride as a processing aid, specifically as a heat
transfer fluid, indicating they were able to meet an ECEL of 2 ppm.
Initial data indicated that the occupational exposure scenario
(cellulose triacetate film manufacturing) used to assess this condition
of use in the 2020 Risk Evaluation of methylene chloride (Ref. 1) may
not have been representative of the overall types of exposures expected
for this condition of use. In the proposed rule, EPA specifically
requested comment on the degree to which other entities using methylene
chloride as a processing aid could comply with the proposed WCPP
requirements for methylene chloride. Numerous commenters provided EPA
with process descriptions, diagrams, and monitoring data, summarized in
this unit and in the Response to Comments document, such that EPA is
now confident that, in general, entities engaged in this condition of
use can meet the requirements of the methylene chloride WCPP (Ref.7).
Numerous commenters submitted information for use of methylene
chloride as a processing aid, including as a heat transfer fluid and in
the production of separators for lithium-ion batteries, as well as
other processing aid uses (Refs. 26, 27, 28, 29, 30, 31, 32, 33, 34,
35, 36). Many of the same commenters also submitted process
descriptions indicating that this use of methylene chloride takes place
in a closed system with little or no personnel interaction (Refs. 26,
27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37). Some commenters provided
EPA with standard operating procedures and describe in detail the use
of respiratory protection (including PPE, as well as other exposure
controls), including during instances of infrequent maintenance or
repair (Refs. 27, 31, 34, 36). Methylene chloride is often cycled
continuously through the enclosed process or, in some cases, recovered
through a distillation process and reused with high efficiency (Refs.
30, 34). Some companies indicated that they are in compliance with the
existing OSHA standard, and though the WCPP requires lower exposure
limits, the WCPP processes such as routine monitoring are similar and
indicate likely success with regards to WCPP compliance (Refs. 26, 27,
28, 29, 30, 31, 35, 36). Of these companies, some supplied monitoring
data that showed compliance levels below the existing OSHA safety
standard and demonstrated the ability to measure at or near EPA's
proposed methylene chloride WCPP 8-hr TWA of 2 ppm, indicating an
ability to comply with the EPA level, and further indicating that the
initial exposure data provided by small entity representatives (SERs)
during EPA's SBAR process is more appropriately representative for this
condition of use than the more general occupational exposure scenario
used by EPA in the 2020 Risk Evaluation for
[[Page 39262]]
Methylene Chloride (Refs. 26, 27, 34, 36, 37, 38). Additionally,
commenters noted that the National Emission Standard for Hazardous Air
Pollutants (NESHAP) for Organic Hazardous Pollutants for Equipment
Leaks at 40 CFR part 63, subpart H requires a robust leak detection and
repair program (Ref. 31).
Use of methylene chloride in the manufacture of separators for
lithium-ion batteries for electric vehicles also falls under use as a
processing aid. Based on information reasonably available to the Agency
at this time, methylene chloride is not currently used in the United
States to manufacture lithium-ion battery separators, with some
companies choosing to use trichloroethylene (TCE) in the production of
battery separators instead (Refs. 39, 40, 41). During the comment
period, at least five commenters described their plans to construct
manufacturing plants for lithium-ion battery separators, specifically
for electric vehicles, that would use methylene chloride as a
processing aid (Refs. 42, 43, 44, 45, 46). Commenters described how
this would strengthen critical supply chains by revitalizing domestic
manufacturing and research and development in accordance with Executive
Order on America's Supply Chains (E.O. 14017) (86 FR 11849, March 1,
2021). Commenters provided details about the process of using methylene
chloride in the manufacture of battery separators. Methylene chloride
is used in the wet manufacturing method of high-quality battery
separators (Refs. 42, 45, 46). In wet manufacturing, polyethylene is
treated to form a porous, monolayer film (Refs. 42, 46). This film is
then treated with low molecular weight oil, stretched, and exposed to a
high-performance solvent to form a uniform microporous structure while
recovering and reusing oils in the manufacturing process (Refs. 42,
46). Methylene chloride works quickly at high temperatures, and is also
desirable because of its low water solubility, and compatibility with
manufacturing equipment (Refs. 42, 46).
Based on the information provided by commenters and other
information reasonably available to the Agency, EPA understands that
separators are fundamental components in batteries that provide the
necessary separation between the internal anode and cathode components
that make batteries work, and that restrictions on the production of
battery separators could critically impact the United States battery
manufacturing supply chain and impede the expansion of domestic battery
production capacity (Refs. 40, 41, 42, 43, 44, 45, 46, 47). EPA
understands that battery separator manufacturing processes are highly-
engineered, specialty products designed precisely to meet stringent
technical specifications that are essential in powering vehicles and
systems in the United States' supply chain for multiple critical
infrastructure sectors.
A commenter who intends to use methylene chloride in a closed
system for battery separator manufacturing submitted monitoring
information indicating exposure at or near the ECEL of 2 ppm (Ref. 42).
Commenters indicate residual methylene chloride is often treated and
recovered as part of this closed process (Refs. 42, 43, 46). EPA agrees
that unreasonable risk from methylene chloride when used as a
processing aid in the manufacture of lithium-ion battery separators,
like other processing aid uses, can be addressed under the WCPP.
Importantly, because companies have not yet begun production, they can
build their plants with the WCPP requirements in mind (Refs. 42, 46).
On October 24, 2023, as part of a proposed regulation to address
the unreasonable risk from TCE under the conditions of use, EPA
proposed a 10-year time-limited TSCA section 6(g) exemption for the use
of TCE in battery separator manufacturing (88 FR 74712, October 31,
2023). The period of the proposed exemption in the TCE proposed rule
would provide sufficient time to transition from TCE to alternatives,
such as methylene chloride. As noted by the commenters, methylene
chloride is currently used overseas to manufacture high quality
lithium-ion battery separators for electric vehicles (Ref. 42). EPA
notes that while the use of methylene chloride in battery separator
manufacturing appears to be analogous to use of TCE for the same
function, based on reasonably available information, current
applications result in different end-use battery products (e.g.,
lithium-ion battery separators manufactured with methylene chloride and
lead acid batteries and lithium battery separators manufactured with
TCE). EPA believes in some cases methylene chloride may soon be a
technologically feasible safer alternative to the industrial use of TCE
as a processing aid in battery separator manufacturing.
Based on information provided by commenters related to processes,
current exposure information and exposure mitigation practices, and
monitoring data, EPA has determined the unreasonable risk from
methylene chloride when used as a processing aid (including as a heat
transfer fluid and in battery separator manufacture) could be addressed
with a WCPP.
2. Industrial and Commercial Use of Methylene Chloride in Plastic and
Rubber Products Manufacturing, Including Polycarbonate Manufacturing
EPA's primary alternative regulatory action described in the
proposed rule included several conditions of use under the WCPP, rather
than prohibition. EPA is finalizing a WCPP for industrial and
commercial use of methylene chloride in plastic and rubber products
manufacturing, including in interfacial polymerization for
polycarbonate plastic manufacturing, as included in the primary
alternative regulatory action of EPA's proposal (88 FR 28284, May 3,
2023) (FRL-8155-02-OCSPP). While EPA proposed to prohibit industrial
and commercial use of methylene chloride in plastic and rubber products
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 methylene chloride
activities for this use to confirm that compliance with an ECEL of 2
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.
Commenters submitted monitoring data for industrial and commercial
use of methylene chloride in plastic and rubber products manufacturing,
which aided EPA with a determination of whether users could comply with
the WCPP. The data provided showed that some companies are close to or
already meeting the proposed ECEL without additional measures being
necessary (Refs. 26, 35, 36).
A commenter also submitted detailed descriptions of methylene
chloride-related activities including for unloading, handling, and
recycling; sample collection; PPE procedures and itemized requirements;
and safety procedures (Ref. 36). The commenter submitted an OSHA
Compliance Plan; training materials for OSHA requirements, PPE, and
hazard recognition; and an Exposure Assessment Program guideline as
well (Ref. 36). Furthermore, the commenter provided details regarding
its interfacial polycarbonate production process using methylene
chloride, which is controlled by an automatic distributed control
system. As described by the commenter in their comment (and confirmed
in a follow-up meeting), workers using the
[[Page 39263]]
system are in an isolated control room that is in a separate location
from the reaction system (Refs. 36, 48). Another commenter stated that
their closed reactor system adheres to recognized and generally
accepted good engineering practices as referenced in OSHA's Process
Safety Management Standard at 29 CFR 1910.119. The commenter also
explained that the methylene chloride used within the reactor system is
recycled within the processing equipment (Ref. 26).
One commenter explained that PPE, including a full chemical-
resistant suit, supplied-air respirators, rubber boots, and chemical
gloves are used where manual operations such as unloading, sampling and
maintenance activities occur (Ref. 36). During the SBAR process, one
SER explained that the methylene chloride is added into the reaction
system directly from tank trailers with hard pipes and flange fittings,
and the product is also packed under vacuum in a scrubber system to
reduce employee exposures, creating little opportunity for exposures
(Ref. 20). Another commenter stated that direct interactions, such as
with sampling, are performed inside glove-box containment systems where
methylene chloride is used within an enclosure and the user interacts
with the sample via a viewing glass and isolation gloves affixed to the
enclosure, similar to those used in laboratory settings and in
industrial sandblasters (Refs. 26, 35).
The information submitted to EPA as part of the comment period
regarding this condition of use, supported by subsequent discussions,
demonstrate the users' ability to comply with the WCPP. For this
reason, EPA has determined that the unreasonable risk from methylene
chloride when used in plastic and rubber products manufacturing
(including in polycarbonate manufacture) could be addressed with a
WCPP.
3. Industrial and Commercial Use of Methylene Chloride in Paint and
Coating Removal From Safety Critical, Corrosion Sensitive Components of
Aircraft and Spacecraft
In the proposed rule, EPA proposed that industrial or commercial
use of methylene chloride for paint and coating removal from safety-
critical, corrosion-sensitive components of aircraft owned or operated
by Federal agencies and their contractors could continue under the
WCPP, and that other commercial use of methylene chloride for paint and
coating removal would be prohibited. EPA also proposed to provide a 10-
year exemption for commercial aviation and commercial aerospace
applications from the proposed prohibition on the use of methylene
chloride in commercial paint and coating removal. Under the primary
alternative regulatory action, EPA included the WCPP for industrial and
commercial use in paint or coating removal from safety-critical,
corrosion-sensitive components of aircraft owned or operated by air
carriers or commercial operators certificated under 14 CFR part 119.
After consideration of public comments, EPA has determined to eliminate
the distinction between defense-related and commercial aircraft, and
allow under the WCPP the continued commercial use of methylene chloride
in paint and coating removal from safety critical, corrosion sensitive
components of aircraft and spacecraft.
Several commenters argued for the removal of the distinction
between defense-related, or Federal agencies, and commercial aircraft
in the proposed rule (Refs. 49, 50, 51). As described by commenters,
critical, corrosion-sensitive components are present and necessary for
the function of all aircraft and spacecraft irrespective of the
customer (Refs. 49, 50), and both defense-related and commercial
aviation or aerospace currently continue to use methylene chloride for
coating removal on these components. Commenters noted that both Federal
and commercial sectors use the same repair and maintenance practices,
maintenance facilities, and environmental health and safety practices,
and that a typical repair or maintenance scenario is that certain parts
are taken off the aircraft and sent to a facility owned and operated by
the part/component manufacturer (Refs. 50, 51, 52). These commenters
contend that the same standard of hazard and exposure control would
therefore be ongoing for both the commercial and the Federal
applications, and both would be likely to be equally equipped to comply
with a WCPP. Both commercial and defense sectors share the same supply
chain, and it is likely that any alternative developed by formulators
will be evaluated by both commercial and defense sectors and, if found
to be a suitable alternative, would be implemented under a similar
timeframe (Ref. 49). For this reason, EPA has determined that the
unreasonable risk from methylene chloride when used in paint and
coating removal from safety critical, corrosion sensitive components of
aircraft and spacecraft could be addressed with a WCPP.
EPA emphasizes that only a narrowly defined subset of commercial
use of methylene chloride for paint and coating removal is allowed to
continue under the WCPP, due to the heavily industrialized and highly
specialized exposure control systems EPA believes to be in place for
both Federal and commercial aviation and aerospace coating removal from
corrosion-sensitive safety-critical parts, such as landing gear, gear
boxes, turbine engine parts, and other aircraft and spacecraft and
components composed of metallic materials (specifically high-strength
steel, aluminum, titanium, and magnesium) and composite materials.
General paint and coating removal on aircraft and spacecraft with
methylene chloride is prohibited. In EPA's view, persons availing
themselves of the WCPP would need to have a reasonable basis to
conclude that the components on which methylene chloride is used are
corrosion-sensitive and safety critical components within the meaning
of the definition. EPA believes such persons could rely, in part, on
information supplied by the manufacturer of the component. A
determination of whether a particular component of an aircraft or
spacecraft is a safety-critical corrosion-sensitive component would be
a fact-specific determination that takes into account the substrate and
character of the component, the effects of methylene chloride paint or
coating remover on the component, and other relevant factors.
4. Industrial and Commercial Use of Methylene Chloride as a Solvent
That Becomes Part of a Formulation or Mixture and the Solvent Will Be
Reclaimed
EPA's primary alternative regulatory action described in the
proposed rule included several conditions of use under the WCPP, rather
than prohibition. EPA is finalizing a WCPP for a sub use of industrial
and commercial use of methylene chloride as a solvent that becomes part
of a formulation or mixture, as included in the primary alternative
regulatory action of EPA's proposal, namely, where that formulation or
mixture will be used inside a manufacturing process, and the solvent
(methylene chloride) will be reclaimed (88 FR 28284, May 3, 2023) (FRL-
8155-02-OCSPP). While EPA proposed to prohibit industrial and
commercial use of methylene chloride as a solvent that becomes part of
a formulation or mixture, this was due to insufficient information at
the time of proposal to determine that the use as a whole could comply
with a WCPP. EPA included this condition of use under the WCPP in the
primary alternative regulatory action, and requested comment on
additional information that could increase the Agency's certainty
[[Page 39264]]
that entities engaged in this use could comply with a WCPP.
EPA received numerous comments describing uses of methylene
chloride in industrial processes which take place in mostly enclosed
systems, such as use of methylene chloride as a processing aid (see
Unit III.A.1.) and in plastic product manufacturing (see Unit
III.A.2.). Likewise, commenters describe some uses of methylene
chloride as a solvent which becomes part of a formulation or mixture
where that mixture is used in a manufacturing process and the solvent
is reclaimed.
Two commenters describe a process in which methylene chloride is
used to dissolve a polycarbonate coating, and then the mixture is run
over a surface where the coating is deposited and the solvent is
reclaimed (Refs. 53, 54, 55). Another commenter describes the use of
methylene chloride in plastic manufacturing processes as a solvent
(Ref. 56). As with the other commercial uses, commenters described
scenarios where methylene chloride is used in a closed system, and
identified that the primary points of exposure in these processes are
the periodic and relatively infrequent loading of methylene chloride.
As described by commenters, the system is enclosed and the methylene
chloride is recovered; the processes are highly industrial and often
remotely performed. One company was able to supply monitoring data that
indicated exposure levels nearly meeting the proposed ECEL (Ref. 54).
In this way, these commenters' uses of methylene chloride are
similar to processing methylene chloride as a reactant, industrial and
commercial use of methylene chloride as a processing aid, and
industrial and commercial use of methylene chloride in plastic product
manufacturing. Namely, when the commercial use of methylene chloride as
a solvent that becomes part of a formulation or mixture results in that
formulation or mixture used inside a manufacturing process, the
methylene chloride is used functionally in the manufacturing process,
frequently in a closed system, and is reclaimed, such that it is not
present in the final manufacturing product. Identification of this
narrowly described use of methylene chloride within a condition of use,
together with information provided by commenters on their specific
processes, led EPA to determine that unreasonable risk from methylene
chloride when used as a solvent that becomes part of a formulation or
mixture, where that formulation will be used in a manufacturing process
and the solvent (methylene chloride) will be reclaimed, could be
addressed with a WCPP.
5. Industrial and Commercial Use of Methylene Chloride as a Bonding
Agent for Solvent Welding
In the proposed rule, EPA proposed that industrial and commercial
use of methylene chloride as a bonding agent for acrylic and
polycarbonate in mission-critical military and space vehicle
applications be allowed to continue under the WCPP. EPA included within
this condition of use the use of methylene chloride in the production
of specialty batteries, and identified the WCPP as an appropriate means
for addressing the unreasonable risk after a specialty battery
manufacturer submitted information on its use of methylene chloride in
chemical welding of acrylic and polycarbonate (Ref. 57). This
application of methylene chloride, unlike adhesives used to bind two
distinct substrates together, dissolves plastic surfaces including, but
not limited to, acrylic or polycarbonate and fuses the substrates into
one continuous unit with increased strength, durability, and seal
integrity (Refs. 58, 59). Mission-critical applications potentially
include fabrication of fixtures and enclosures for scientific research;
production of optically clear articles such as space vehicle windows,
space suit helmet components, or elements of extraterrestrial habitats;
or hermetically sealing the plastic cases of specialty batteries.
Following publication of the 2023 proposed rule, EPA received
additional public comments describing other applications of methylene
chloride used in a similar fashion; however, these applications were
not in mission-critical military and space vehicle applications, or in
the production of specialty batteries for such applications (Refs. 58,
60, 61).
Bonding agents used to chemically weld acrylics or polycarbonates
with methylene chloride do not have a technically or economically
feasible safer alternative available. This application is uniquely
different from adhesives which do have technically or economically
feasible safer alternatives available. Commenters that described their
use of methylene chloride indicated that they require low quantities of
methylene chloride for its effect and stated that they are currently in
compliance with the OSHA methylene chloride standard at 29 CFR
1910.1052 (Refs. 59, 60). Based on the information received, and the
similarities across multiple uses of methylene chloride as a bonding
agent--but not as an adhesive--EPA believes that the WCPP will address
the unreasonable risk for use of methylene chloride as a bonding agent
in general, and is therefore expanding its initial scope of this
allowed use under the WCPP from mission-critical military and space
vehicle applications to general industry.
B. Delayed Compliance Dates for Prohibitions
1. Commercial Use of Methylene Chloride in Refinishing for Wooden
Furniture, Decorative Pieces, and Architectural Fixtures of Artistic,
Cultural or Historic Value
EPA proposed to prohibit the commercial use of methylene chloride
for paint and coating removal, including for all commercial furniture
refinishing. While EPA proposed to exclude commercial furniture
refinishing from the regulation of the use of methylene chloride in
commercial paint and coating removal in 2017, the 2023 proposed rule
did not exclude commercial furniture refinishing from the proposed
prohibition on the use of methylene chloride for commercial paint and
coating removal, because EPA determined that this use contributes to
the unreasonable risk presented by methylene chloride.
EPA's proposed rule included an analysis for an exemption under
TSCA section 6(g) for industrial and commercial use of methylene
chloride as a paint and coating remover in furniture refinishing, and
preliminarily determined that an exemption was not warranted. EPA
solicited comment on its analysis, including information on the
availability of alternatives, the time needed to implement
alternatives, and other information related to this condition of use.
After reviewing comments and conducting additional outreach, EPA found,
as in the proposed rule, that a broad exemption for commercial use of
methylene chloride in paint and coating removal for all types of
furniture refinishing uses under TSCA section 6(g)(1)(A) is not
warranted because the use of methylene chloride for all types of
furniture refinishing is not a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure.
However, EPA acknowledges that for particular circumstances, such
as removing coatings from wooden furniture and other items that are of
artistic, historic or cultural significance, there is no technically or
economically feasible safer alternative to methylene chloride currently
available. Therefore,
[[Page 39265]]
to provide a reasonable and appropriate transition period in the final
rule (consistent with TSCA sections 6(c)(2)(C) and 6(d)(1)(E)), EPA is
delaying compliance with the prohibition for commercial users engaged
in those activities, with certain interim requirements to reduce worker
exposures.
As discussed in this unit, while in some cases alternatives are
available for commercial use of methylene chloride in refinishing
wooden furniture, decorative pieces, and architectural fixtures, this
is not the case for wooden pieces that are of artistic, cultural or
historic value. These pieces tend to have increased value because of
their age; their association to significant cultural figures,
buildings, or events; or due to a combination of these factors.
Additionally, they may contain complex geometries, such as hand-carved,
ornate embellishments and grooves or other intricate patterns. The
aesthetic and structural integrity of these pieces contributes to their
value, function, or both, and therefore must be preserved during the
refinishing process. In other words, to the extent that alternative
methods or formulations may be able to remove a coating, if they affect
the underlying substrate's appearance, structural integrity, or
functionality, those are not feasible alternatives for wooden pieces
that are of artistic, cultural, or historic value. In the absence of
such viable alternatives, cultural items such as religious articles of
virtu, musical instruments, and ceremonial utensils would be degraded
or rendered non-functional. In some cases, these wood pieces may be
original, priceless, or irreplaceable and cannot be remade by simply
commissioning an artisan to craft a replacement. Examples of these
types of artistic, cultural, or historic pieces include but are not
limited to: Library furniture and architectural woodwork at Harvard
University (Ref. 62); the Reredos at St. Paul's School (Ref. 62); the
John F. Kennedy (JFK) Podium at the JFK Library (Ref. 62); and the
Arlington Cemetery Old Guard Caisson (Ref. 63).
Based on information provided to EPA, these types of wooden pieces
would be aesthetically or structurally compromised by alternative
refinishing techniques or chemicals other than methylene chloride (Ref.
64). Alternatives, both chemical and mechanical, can damage the
underlying substrate; present flammability hazards; and take much
longer to work such that they are prohibitively expensive. This section
provides additional details from commenters and other sources on each
of these three qualities, which led EPA to determine there are no
technically or economically feasible, safer alternatives for use of
methylene chloride to refinish wooden pieces of artistic, cultural, or
historic value.
At the time of proposal, EPA identified many alternative products
to methylene chloride for paint and coating removal, and noted that
some may require adjustments to equipment and processes for furniture
refinishing or longer periods of time, or may not be appropriate
alternatives for use on wood substrates (88 FR 28313). In public
comments, commenters emphasized that these alternatives present their
own risks, and that they are more likely to be used in paint and
coating removal where the integrity and aesthetics of the substrate may
be less critical to the refinished product. Commenters emphasized that
for the highly complex geometries which may be common in wooden
furniture, decorative pieces, and architectural fixtures of artistic,
cultural, or historic value, methylene chloride-containing paint and
coating removers are the only products that can remove coatings without
damaging the underlying wood (Refs. 62, 65, 66). Similar issues arise
when utilizing mechanical or thermal methods, because--while they may
be useful for some types of paint and coating removal--they may damage
the underlying structure, take so long to work that they are
prohibitively expensive, and cannot reach into the grooves of complex
geometries (i.e., sanding, media blasting, or heat guns) (Refs. 20, 66,
67, 68, 69).
There are significant challenges to replacing methylene-chloride
based paint and coating removers in furniture refinishing; these
challenges are exacerbated with wood compositions of artistic,
cultural, or historic value, since the integrity or character of the
piece would be compromised by alternatives to methylene chloride.
Methylene chloride-based formulations are the paint removers of choice
for furniture refinishers in part because they are not flammable (Ref.
20). Based on the public comments received, EPA also understands that
an abrupt prohibition on use of methylene chloride in this sector could
push furniture refinishers to adopt less safe alternatives, notably
substances that are flammable. Currently, based on information
available to EPA and provided in public comments, some alternative
paint and coating removal formulations are flammable (Ref. 3). EPA's
alternatives analysis identified 47 chemicals in paint and coating
remover formulations with reasonably available hazard information; of
those, 33 are flammable to varying degrees (Ref. 13). EPA notes concern
from commenters about the strong likelihood of regrettable
substitutions in instances where combustible materials and flammable
liquids may be used in tandem and result in a combined Class-A and
Class-B fire, as defined by OSHA in 29 CFR 1910.155 (Refs. 62, 66, 70,
71), in workshops where environmental conditions are likely to contain
fine, combustible particulates in larger quantities such as saw dust or
wood shavings.
Additionally, based on information provided by commenters,
currently available alternative paint and coating removers used in
furniture refinishing can take significantly longer for the desired
effect and may require multiple applications and scraping to carefully
remove the coating, adding additional time and labor to the process
(Refs. 66, 70). Multiple applications and manual removal of coatings
from artistic, cultural, or historic pieces--particularly those with
irregular or intricate shapes--increases the likelihood of damaging the
underlying wood substrate and presents increasing labor and cost
challenges for this practice. Additionally, an abrupt prohibition of
methylene chloride use resulting in additional time and labor would
result in a price increase in this sector; as EPA noted in the proposed
rule, this may result in significant financial challenges in a sector
where profit margins are already narrow at about 3.8% of sales (Ref.
67). Due to the added time, labor, and cost that an alternative would
pose, commenters contend that the likelihood of this sector remaining
viable would be minimal and, as commenters describe, may result in
immediate furniture disposal to landfills that would have otherwise
been recycled through refinishing (Refs. 64, 66). As discussed earlier
in this unit, commenters have noted that that while alternative
chemicals or substitute methods could be used where the integrity and
aesthetics of the substrate may be less critical to the refinished
product, they also emphasized that methylene chloride is uniquely
suitable for removing coatings and refinishing complex pieces made of
wood that cannot be replaced if damaged, due to its artistic, cultural,
or historic value.
While EPA believes that in many instances, furniture refinishing
can be successfully accomplished with alternatives to methylene
chloride, in consideration of public comments, EPA has determined that
there is no technically or economically feasible alternative that
benefits health for
[[Page 39266]]
commercial use of methylene chloride in paint and coating removal for
the refinishing of wooden compositions of artistic, cultural, or
historic value, since the integrity or character of the piece would be
compromised by alternatives to methylene chloride. Therefore, to
provide a reasonable and appropriate transition period, EPA's final
rule will delay, until five years after the publication of this final
rule, compliance with prohibitions for commercial use of methylene
chloride for refinishing wooden pieces which are of artistic, cultural,
or historic value, with interim requirements for exposure controls,
based on best practices described by furniture refinishers.
Commenters provided information on engineering and exposure
controls, allowing EPA to identify how risks could be reduced before
prohibitions went into effect, even if the unreasonable risk could not
be completely addressed. Based on information received, entities
engaged in the use of methylene chloride for commercial furniture
refinishing have a number of options for engineering and administrative
controls to reduce exposure; some commenters noted that exposures may
currently be under the OSHA action level of 12.5 ppm (Ref. 72). Types
of controls that facilitate low levels of exposure include engineering
controls with linear airflow, such as some spray booths typically used
for painting, but which can also be used for paint and coating removal
(Ref. 73). Other examples include custom engineering controls where
fans bring in fresh exterior air, while an additional ventilation
system pulls methylene chloride vapors down and away from the user's
personal breathing zone (Refs. 64, 72). Because methylene chloride
vapors are heavier than air and naturally flow downward, the intake
that removes methylene chloride vapors is intentionally positioned
below the working station, and in some instances incorporated into the
refinishing equipment, such as at the base of a flow-over tray, to draw
the volatilized methylene chloride vapors down and away from the user
quickly (Ref. 72). Additionally, as commenters noted, it is common
practice for refinishing shops to conduct their refinishing activities
in batches, so that, for example, methylene chloride is only present in
the workplace once a week or month, rather than every day (Refs. 64,
66).
EPA recognizes the challenges of developing and transitioning to
technologically and economically feasible alternative paint and coating
removers for some applications. However, while some furniture
refinishing businesses have successfully implemented custom engineering
controls for their operations, EPA remains concerned about the
feasibility of long-term WCPP compliance for many businesses in this
sector. Custom ventilation systems, as well as equipment and training
for the use of supplied-air respiratory protection are burdensome to
procure and implement, but would be necessary to ensure protection of
human health from this use. Because of the magnitude of exposure for
this application, which is primarily conducted in flow over trays and
dip tanks, air supplied respirators--and associated monitoring--would
likely be a key part of reaching an ECEL of 2 ppm, adding additional
expense. While EPA expects a majority of commercial users of methylene
chloride to be familiar with the OSHA standard, and therefore familiar
with many of the requirements of a successful WCPP, in the furniture
refinishing sector many workshops are run by self-employed artisans,
who would not be subject to OSHA regulations. EPA has encountered
furniture refinishers who were using cartridge respirators, despite the
fact that, as specified in the OSHA methylene chloride standard at 29
CFR 1910.1052, only supplied air respirators are effective against
methylene chloride, since cartridges are quickly eroded by methylene
chloride vapors. Since 1985, at least seven deaths have been attributed
to use of methylene chloride for paint stripping in the Reupholstery
and Furniture Repair Sector (Ref. 11). While EPA acknowledges the
commitment of furniture refinishers that aim to protect workers while
providing a high-quality service, EPA remains concerned that WCPP
implementation could present significant and widespread difficulties in
this sector, resulting in high non-compliance rates that would
undermine the health-protectiveness of the rule and leave unreasonable
risks of injury to health unmitigated. In the preamble to the proposed
rule, EPA sought public comments regarding the commercial use of
methylene chloride in furniture refinishing, as well as detailed
information as part of any comments requesting that EPA consider a
regulatory alternative that would subject more conditions of use to the
WCPP, instead of prohibition. EPA requested that these comments provide
``monitoring data and detailed descriptions of methylene chloride
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'' (88 FR 28284, May 3, 2023) (FRL-
8155-02-OCSPP). For commercial use of methylene chloride in furniture
refinishing, EPA did not receive this information and the information
provided by commenters did not provide EPA with adequate information to
establish that furniture refinishers could successfully comply with the
WCPP, or that could serve as roadmap for how furniture refinishers
might adapt their processes to reduce exposures such that the risks
were no longer unreasonable (EPA-HQ-OPPT-2020-0465-0228, -0233, -0285).
For example, commenters did not provide monitoring data for this
condition of use, or detailed estimates of the quantity of methylene
chloride used. Information that would have helped EPA to evaluate
whether commercial use of methylene chloride in furniture refinishing
could continue under the WCPP would have included: monitoring
information indicating compliance with the OSHA Permissible Exposure
Limit (PEL) or a lower threshold such as the EPA ECEL, potential
process changes that could mitigate exposure to methylene chloride,
typical administrative and engineering controls, and other
occupational, environmental, safety, or health practices that are
currently implemented. EPA notes that other industries, such as those
engaged in the industrial and commercial use of methylene chloride as a
processing aid and industrial and commercial use of methylene chloride
in plastic product manufacturing, were able to provide such data during
the comment period. Additionally, while commenters did emphasize the
importance of methylene chloride in furniture refinishing, they did not
provide specific information regarding EPA's solicitation on comments
``on how costs and economic impacts from firm closure may be reduced
with longer compliance timeframes.''
As described in the proposed rule (88 FR 28284, May 3, 2023) (FRL-
8155-02-OCSPP), EPA identified the commercial use of methylene chloride
in furniture refinishing as contributing to the unreasonable risk and,
despite extensive stakeholder engagement (described in Units III.B.1.
and V.A.4. of the proposed rule) (88 FR 28284, May 3, 2023) (FRL-8155-
02-OCSPP), could not conclude that work practices could be modified to
such an extent that exposures could be reduced sufficiently to address
the unreasonable risk. Based on stakeholder interest in continuing this
use of methylene chloride, EPA solicited comments in the proposed rule
[[Page 39267]]
specifically to increase the information available to EPA to inform for
this final rule, whether the use could move to the WCPP rather than
prohibition. While EPA appreciates the public comments provided, they
did not supply the information necessary.
However, in recognition of the challenging and particular
circumstances faced by furniture refinishers engaged in restoring and
removing coatings from wooden pieces of artistic, cultural, or historic
value, and to address the unreasonable risk from methylene chloride
contributed by this condition of use, EPA is finalizing a delayed
compliance date of five years for the use of methylene chloride in a
subset of furniture refinishing for these specialty wood pieces where
workshops can meet a minimum standard of exposure control.
In order to participate in the delayed compliance with the
prohibition, owners/operators must meet a minimum standard of exposure
control. That includes: (1) use of a regulated area; (2) use of local
exhaust ventilation, both bringing air in from outside of the workspace
where methylene chloride is being used and pulling methylene chloride
vapors away from the potentially exposed persons; and (3) use of any
NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or airline
respirator in a demand mode equipped with a full facepiece (Assigned
Protection Factor (APF) 50) or any NIOSH Approved[supreg] Self-
Contained Breathing Apparatus (SCBA) in demand-mode equipped with a
full facepiece or helmet/hood (APF 50) or the appropriate respirator
based on initial monitoring as outlined in Unit IV.B.4.b. or 40 CFR
751.109(d) of the regulatory text. EPA expects that within five years,
either new alternatives to methylene chloride for paint and coating
removal for refinishing wooden pieces of artistic, cultural, or
historic value will be identified and put into use, similar to how
alternatives to methylene chloride for consumer paint and coating
removal were developed and marketed quickly in advance of EPA's 2019
prohibitions, or facilities will be able to refine processes and
workshop equipment to incorporate alternative methods for chemical
paint and coating removal. EPA emphasizes that the Agency would also
continue to be willing to review data on exposures to methylene
chloride in furniture refinishing, and in particular any data
indicating that furniture refinishers could meet the ECEL of 2 ppm over
an 8-hr TWA, the EPA STEL of 16 ppm as a 15-minute TWA, or otherwise
consistently comply with the WCPP, and could revise this final rule
accordingly if such data were provided.
2. Industrial and Commercial Use of Methylene Chloride in Adhesives and
Sealants
EPA proposed to prohibit the industrial and commercial use of
methylene chloride in adhesives, sealants, and caulks; paints and
coatings; paints and coating removers for non-corrosion sensitive
parts; and lubricants. TSCA section 6(d) requires EPA to specify
mandatory compliance dates for all requirements of a TSCA section 6(a)
rule. The mandatory compliance dates must be ``as soon as practicable''
and ``provide for a reasonable transition period.'' Except for full
implementation of a ban or phase-out of a chemical substance, the
mandatory compliance date for a requirement in a TSCA section 6(a)
rule, including the start of ban or phase-out requirements, must be no
later than five years after the date of promulgation of the final rule.
EPA proposed that the prohibitions on commercial use of methylene
chloride--in adhesives, sealants, and caulks as well as nearly all
other commercial uses--take effect 450 days after publication of the
final rule in the Federal Register. In public comments, regulated
entities in the aerospace sector described anticipated challenges with
the proposed timeframe for the prohibitions, and requested a 10-year
delayed compliance date for their uses of methylene chloride within
these conditions of use (Refs. 49, 51, 52). While EPA partially agrees
with some aspects of the rationale provided by commenters, EPA
maintains that technically and economically feasible alternatives to
methylene chloride are currently available for a majority of these
applications, and formulations containing methylene chloride are not
uniquely specified to industry or military standards for paints and
coatings; paints and coating removers for non-corrosion sensitive
parts; and lubricants. Therefore, the prohibition timeframes in this
final rule, which take full effect after two years as described in Unit
III.E., should be sufficient for regulated entities to identify and
implement alternatives for paints and coatings; paints and coating
removers for non-corrosion sensitive parts; and lubricants.
Two additional commenters requested that EPA consider delayed
compliance for use of methylene chloride in adhesives and sealants in
the aerospace and defense sectors; one commenter provided rationale in
support of a delayed compliance date of five years (Refs. 50, 61). The
commenter described how certain methylene chloride adhesives and
sealants used in turbine engines and aircraft systems do not currently
have methylene chloride-free alternatives identified, including
applications such as: use in bonding critical turbine engine hardware,
use as a jointing compound in engine parts, adhesive to bond
capacitors, transformers, components, military printed circuit (PC)
boards and subassemblies, and gasket sealant in aerospace systems (Ref.
50). The commenter estimated that properly qualifying these products
may take as long as five years and requested delayed compliance (Ref.
50). EPA agrees that five years is a reasonable compliance timeframe
for the identification and qualification of methylene chloride-free
alternatives to both industry and Federal standards for these uses, and
is therefore finalizing delayed compliance of five years before
prohibition for industrial and commercial use of methylene chloride in
adhesives and sealants when that adhesive or sealant is used in
aircraft, space vehicle, or turbine applications for structural and
safety critical non-structural applications.
In contrast to the delayed compliance with the prohibition for a
subset of furniture refinishers as described in Unit III.B.1., EPA is
not requiring interim controls during the period of delayed compliance
for this subset of adhesive and sealant users. This is because for
industrial and commercial use of methylene chloride in adhesives and
sealants when that adhesive or sealant is used in aircraft, space
vehicles, or turbine applications for structural and safety critical
non-structural applications, EPA does not have the same concerns for
magnitude of risk that could result in occupational fatalities from
acute exposures as EPA has for furniture refinishing. In other words,
while unreasonable risk as a result of either acute or chronic
exposures exists for industrial and commercial use of methylene
chloride in adhesives and sealants when that adhesive or sealant is
used in aircraft, space vehicles, or turbine applications for
structural and safety critical non-structural applications, the
magnitude of those risks in comparison to the benchmark, as well as
information about existing controls in this sector, did not lead EPA to
determine that prescribing minimum interim controls for the duration of
the phaseout was necessary for this use. This is in contrast to
commercial use of methylene chloride in furniture refinishing, for
which EPA has concerns for fatalities due to acute
[[Page 39268]]
exposures, as a result of the magnitude of risk for that condition of
use. For these adhesive and sealant applications, the volume of
adhesive used, the percent formulation of methylene chloride, as well
as the proportion of industrial (as opposed to commercial) workspaces,
is much less compared to the furniture refinishing sector, which is
reflected by the risk characterization driving the unreasonable risk
determination for both furniture refinishing and adhesive and sealant
conditions of use (Ref. 1). While interim exposure controls are not
required by EPA during the delayed prohibition for this use, EPA
expects that owners or operators will continue to comply with OSHA's
methylene chloride standard under 29 CFR 1910.1052 until either a
successful transition to an alternative has been achieved, or the
delayed prohibition timeframe has been exhausted, whichever is sooner.
C. De Minimis Threshold
In the proposed rule, EPA requested comment on whether the Agency
should consider a de minimis threshold of methylene chloride in
formulations when finalizing prohibitions, and, if so, what threshold
should be considered de minimis. EPA received numerous comments in
support of the inclusion of a de minimis threshold (Refs. 30, 37, 49,
51, 52, 55, 56, 65, 74, 75, 76, 77, 787, 79). Of those, a majority of
commenters agreed with the EPA suggestion of using 0.1% by weight as
the de minimis threshold for the applicability of prohibitions and
restrictions on methylene chloride; in some cases, commenters noted
that this threshold would be consistent with the requirements under the
OSHA Hazard communication standard at 29 CFR 1910.1200 (Refs. 30, 31,
37, 38, 49, 51, 53, 55, 65, 74, 75, 78, 79, 80).
The OSHA Hazard communication standard at 29 CFR 1910.1200 defines
``health hazard,'' and provides criteria for determining whether a
chemical is classified as a health hazard in Appendix A to 29 CFR
1910.1200--Health Hazard Criteria. 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 methylene chloride, is
classified as a carcinogen (Ref. 81). Other EPA programs, such as the
Toxics Release Inventory (TRI) program, have adopted a de minimis
threshold of 0.1% for chemicals which are defined as carcinogens or as
a potential carcinogen under the National Toxicology Program,
International Agency for Research on Cancer, or OSHA (see 40 CFR
372.38(a)).
Some commenters, rather than suggesting a particular de minimis
threshold, suggested EPA identify a de minimis that is risk protective
(Refs. 82, 83). For methylene chloride, due to the type and quantity of
reasonably available information, EPA conducted an analysis using input
parameters and exposure scenarios from the 2020 Risk Evaluation for
Methylene Chloride to confirm that methylene chloride, when present at
a threshold of 0.1% by weight, does not contribute to unreasonable risk
under the conditions of use (Ref. 84). EPA's final rule includes a de
minimis threshold of 0.1%. The adoption of a de minimis threshold in
this final rule means that products in which methylene chloride is
present below 0.1% by weight are not subject to the restrictions
outlined in this rulemaking.
D. 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 requirements that
initial exposure monitoring be conducted within 180 days of publication
of the final rule in the Federal Register, that each owner or operator
ensure that the airborne concentration of methylene chloride does not
exceed the ECEL or EPA STEL for all potentially exposed persons within
270 days of publication of the final rule in the Federal Register, and
that owners and operators implement an exposure control plan within 360
days of publication of the final rule in the Federal Register. In the
primary alternative regulatory action described in the proposed rule,
EPA described longer timeframes: initial exposure monitoring under the
WCPP within 360 days; that each owner or operator ensure that the
airborne concentration of methylene chloride does not exceed the ECEL
or EPA STEL for all potentially exposed persons within 450 days of
publication of the final rule in the Federal Register, and that owners
and operators implement an exposure control plan within 540 days of
publication of the final rule in the Federal Register.
After considering comments regarding timeframes needed for
implementing the WCPP, EPA has determined that the timeframes in the
alternative regulatory action would ensure that the regulated community
has adequate time to assess, formulate, procure, and implement the
required chemical safety program for methylene chloride.
EPA's proposed rule included an analysis of the alternative
regulatory action and preliminarily determined that the proposed
timeframes for compliance with the WCPP were appropriate. For the
proposed regulatory action compliance timeframe, EPA adopted timeframes
similar to those previously promulgated by OSHA in the 1997 update to
the methylene chloride standard at 29 CFR 1910.1052. However, public
comments indicated that OSHA's compliance timeframes are not
universally appropriate, especially when considering that the proposed
ECEL and EPA STEL are an order of magnitude lower than the current OSHA
PEL and would require additional time to execute properly, in some
instances requiring the adoption of new methods (see section 5.1.2 in
the Response to Comments document (Ref. 7) for a full discussion of
methylene chloride monitoring methods and the PEL). Commenters also
stated an additional concern that the proposed timeframes would be
insufficient to document the novel efforts required under the WCPP to
document the use of the hierarchy of controls (Ref. 55, 70).
Other commenters highlighted additional challenges with the
proposed timeframes. For example, one commenter anticipated an
increasing need for professional services from industrial hygienists,
engineers, or others in order to implement and maintain the WCPP as
proposed (Ref. 19). To this end, a commenter stated that the proposed
regulation could put an unintended strain on the safety industry and
laboratories required to analyze monitoring samples due to the sudden
increase in demand for such services (Ref. 85). The commenter expressed
concern that the increased demand for safety professional services may
result in lowered standards and practices (Ref. 85). Other commenters
added that facilities would need to determine if a corporate exposure
assessment strategy would need to be reassessed for the proposed ECEL
and EPA STEL (Refs. 55, 70). Moreover, because the current OSHA
standard contains criteria for the discontinuation of air monitoring
for methylene chloride, it is likely that some entities have not
monitored for inhalation exposures for an extended period of time. For
situations such as this, a corporate exposure assessment strategy or
similar mechanism would necessitate the procurement of professional
services, adding logistical demand for these specialized services.
In consideration of the challenges of initiating the WCPP, even for
facilities with industrial hygiene programs in place, and given the
difference in the occupational exposure limits between
[[Page 39269]]
the OSHA PEL and the EPA ECEL that may spur an increase in the need for
monitoring or other exposure control assessment infrastructure, EPA
determined that a longer compliance deadline of 12 months, as provided
in the primary alternative regulatory action described in the proposal,
would be an appropriate timeframe to conduct initial monitoring, which
likely would require regulated entities to contract new services or
realign current industrial hygiene professionals toward WCPP
compliance. Adopting this timeframe from the alternative approach
(providing 12 months 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 additional time for a comprehensive exposure
evaluation, increasing the likelihood of successful implementation of
the WCPP.
As noted by commenters, the proposed 180-day compliance timeframe
would not provide a sufficient amount of time to identify similar
exposure groups and facilitate effective initial exposure monitoring,
and as a result, this raised concern regarding the successful
implementation of the WCPP for regulated entities. When EPA initially
proposed compliance timeframes for the WCPP, beginning with initial
monitoring at 180 days and requiring full implementation of the WCPP
for methylene chloride by 360 days, EPA pursued similar approaches to
OSHA's 1997 revision of the methylene chloride standard in an effort to
swiftly address unreasonable risk to workers. While EPA expected some
processes to be streamlined given the familiarity of its proposed
regulatory structure, information submitted to EPA stated that delayed
compliance is necessary to identify staffing needs, to properly
evaluate facilities for exposures using the ECEL and EPA STEL, and to
fully implement the WCPP (Refs. 55, 70). Furthermore, in addition to
the possible service professionals identified by EPA in the IRFA (Ref.
19), commenters noted that an expanded scope of individuals would be
required to implement a WCPP, including operations managers, process
engineers, and process safety management engineers (Refs. 19, 55, 70).
Information was also provided to EPA during the comment period
detailing evaluation steps that would be required to assess a facility
and fully implement a WCPP, specifically to perform appropriate initial
monitoring. The steps noted by commenters included development of an
exposure assessment strategy (which requires the identification of
stakeholders), the development of methods to gather information, the
use of similar exposure groups, the determination of analytical
methods, and the training for proper execution of monitoring, including
the assessment strategy and exposure characterization (Refs. 55, 70).
Another commenter provided information on its process for establishing
monitoring to the EPA exposure level, which substantiated the steps
identified by the trade associations. This stakeholder was already in
the process of refining its monitoring approach for its unique
exposures. The stakeholder claimed that additional time is warranted
for targeted exposure evaluations that would be most representative of
tasks performed in its facilities (Ref. 48). Given the precedent of
existing OSHA methylene chloride standards, EPA recognizes that much of
the infrastructure and methods needed for monitoring may already be in
place; however, EPA also acknowledges concerns expressed by commenters
that adequate time would be needed to monitor to EPA's lower exposure
levels (Refs. 55, 70). After consideration of comments and outreach
conducted following publication of the 2023 proposed rule, due to the
increased scope of exposure evaluation processes and required
personnel, EPA determined that a delayed compliance date of 360 days to
conduct initial monitoring and 540 days to fully implement the WCPP as
described in the proposed primary alternative regulatory action is
necessary, and is finalizing such a timeframe in this rule.
Although stakeholders commented that a minimum of 720 days to 1,080
days would be necessary to fully implement the WCPP (Refs. 55, 58, 70),
EPA considers that suggested change to the proposed timeframe to be
excessively lengthy for methylene chloride and would not be in
compliance with the TSCA section 6(d) requirement that implementation
dates be as soon as practicable (Refs. 55, 58, 70). EPA recognizes that
certain provisions in the Final Rule are new and diverge from existing
OSHA regulatory requirements for methylene chloride, and that
additional time is warranted to fulfill those requirements. This could
include, but is not limited to, the need to formulate an exposure
sampling strategy, consult with specialized service providers, contract
with specialty service providers or sampling laboratories, purchase PPE
and respirators, procure capital for facility retrofitting, train
workers on new types of PPE and administrative procedures, calibrate
equipment, or design and install new engineering controls (Refs. 35,
55, 70). Based on comments, outreach, reasonably available information,
and long-established OSHA standards for methylene chloride, 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 monitoring to new, lower EPA
exposure thresholds. Therefore, EPA determined that, as outlined in the
proposed primary alternative regulatory action, providing additional
time for the initial monitoring step with staggered requirements
following in three-month increments will be sufficient for much of the
regulated community and provide significant benefit towards the
successful implementation of the WCPP. Specifically, for the private
sector, EPA is finalizing the proposed primary alternative regulatory
timeframes for WCPP implementation, including 360 days for initial
monitoring, 450 days to ensure that no person is exposed to an airborne
concentration of methylene chloride that exceeds the ECEL or EPA STEL,
and 540 days to implement an exposure control plan.
However, EPA remains concerned about the ability of certain
departments and agencies of the Federal Government, as well as Federal
contractors acting for or on behalf of the Federal Government, to
comply with these timeframes. The importance of methylene chloride to
mission-critical Department of Defense and National Aeronautics and
Space Administration (NASA) operations and overall military readiness
is discussed in Units III.A.5. and III.B.1., as well as throughout the
proposed rule. While, for example, 29 CFR part 1960 sets forth
procedures and guidelines for ensuring that Federal workers are
protected in comparable ways to their private sector 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
an additional year for agencies of the Federal Government and their
contractors, when acting for or on behalf
[[Page 39270]]
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 methylene chloride that exceeds the
ECEL or EPA STEL, and 1,095 days to implement an exposure control plan.
2. Changes to Prohibition Timeframes
For occupational conditions of use subject to a prohibition, EPA
proposed that prohibitions would become effective in a staggered
schedule for each stage of the supply chain and would come into effect
in 90 days for manufacturers, 180 days for processors, 270 days for
distributors to retailers, 360 days for all other distributors and
retailers, and 450 days for industrial and commercial uses after the
publication date of the final rule in the Federal Register. For
consumer uses, EPA proposed that the prohibitions of manufacturing,
processing, and distribution in commerce of methylene chloride for
consumer use would occur in 90 days for manufacturers, 180 days for
processers, 270 days for distributing to retailers, and 360 days for
all other distributors and retailers after the publication date of the
final rule in the Federal Register. The EPA proposed primary
alternative regulatory action included longer timeframes, which begin
at 360 days for manufacturing, 450 days for processors, 630 days for
all other distributors and retailers, and 720 days for industrial and
commercial users.
Several commenters raised concerns on the timeframe for complying
with prohibitions from the proposed regulatory action, stating that it
does not allow sufficient time to identify, research, test, qualify,
and implement alternative substances or processes (Refs. 75, 83, 86,
87). A commenter also noted that adopting use of alternatives would
involve making engineering changes to allow for the manufacturing,
processing, and use of alternatives (Ref. 87). Another commenter
highlighted the general challenges in implementing shifts to
alternative chemicals or formulations for industries with multi-tiered
supply chains (Ref. 83). EPA acknowledges and agrees that there likely
will be circumstances in which chemical alternatives may not be an
exact, drop-in replacement for conditions of use, or in which new,
additional, or modifications to existing engineering equipment could be
required, and that 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) may require a transitioning
process. This point was expanded upon by a commenter who stated that
the identification, testing, and implementation of alternatives would
not only affect the commercial users of methylene chloride, but would
also impact their distributors and customers downstream (Ref. 86). Due
to these and other concerns, some commenters supported the proposed
alternative timeframe for prohibition, which would provide additional
time that commenters described as necessary for seeking alternatives,
successfully implementing their use, and mitigating supply chain
impacts (Refs. 50, 60, 70, 83). After reviewing all of the comments,
EPA is modifying the proposed prohibition compliance timeframe for
industrial and commercial uses to lengthen it in this final rule, to
allow for successful implementation of the prohibitions, as outlined in
the proposed alternative regulatory action. This extension will also
provide additional time for industry 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 Unit IV.C.
Regarding consumer use of methylene chloride, while many commenters
that provided input emphasized the need for a longer prohibition
compliance timeframe for manufacturers, formulators, or distributors of
these products, other commenters believed EPA should maintain or
expedite the timeline for prohibitions related to consumer use (Refs.
88, 89). Commenters emphasized the severity of the hazards posed by
methylene chloride (including to consumer users and bystanders to
consumer use), particularly the acute hazards which can include death.
Commenters cited the available alternatives for consumer uses, which
EPA also noted in the proposed rule (Ref. 13). EPA has not found that
transitions to alternatives to methylene chloride for consumer use
involve the same considerations or the need for extended timeframes as
for commercial use. Therefore, EPA is finalizing the prohibition
implementation timeframe from the proposed regulatory action for
retailer restrictions to expeditiously restrict access by consumers,
while allowing additional transition time for the commercial sector.
EPA is finalizing this with the proposed alternative action timeframes
for manufacture, processing, use, and all other distribution (i.e.,
non-retailer) for industrial and commercial use, while finalizing the
proposed timeframes for distribution to and by retailers for consumers.
As described in the proposal, and in Unit IV.C., a retailer is any
person or business entity that distributes or makes available products
to consumers, including through e-commerce internet sales or
distribution.
EPA acknowledges that the final approach potentially allows for
manufacturing and processing of methylene chloride and methylene
chloride-containing products for three to six months beyond when they
could be distributed to or by retailers. EPA took this approach to
expeditiously remove methylene chloride-containing products from the
consumer market. While EPA acknowledges that, in some cases, upstream
manufacturers and processors may lack awareness of the downstream uses
of their products, in the case of methylene chloride, manufacturers and
processers should be aware of restrictions downstream (distributing to
and by retailers) that would make them unable to distribute products
that end up on the consumer market, as a result of the 2019 rulemaking
prohibiting methylene chloride in paint and coating removers for
consumer use because that regulation required manufacturers of
methylene chloride, regardless of downstream uses, to revise their SDS
effective August 26, 2019 (84 FR 11420, March 27, 2019) (FRL-9989-29).
EPA intends to conduct outreach with the regulated community and
particularly manufacturers of methylene chloride, who have been
actively engaged throughout the rulemaking and risk evaluation process,
to address this issue.
With a combination of proposed timeframes and primary alternative
timeframes presented in the proposed rule, the prohibitions under this
finalized regulatory action will take effect in 270 days for
distributing to retailers, 360 days for retailers distributing more
broadly, 360 days for manufacturers, 450 days for processors, 630 days
for all other distributors and 720 days for industrial and commercial
users following this publication of the final rule in the Federal
Register. EPA is also finalizing downstream notification requirements
in accordance with these changes; details of these changes are outlined
in Unit IV.D.2.
E. Changes to WCPP Requirements: Exposure Monitoring Requirements
As part of the WCPP, EPA proposed to require that owners or
operators meet certain documentation requirements for
[[Page 39271]]
each instance of monitoring of methylene chloride, 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. Commenters stated that it is atypical, for industrial hygiene
purposes, to use this standard for air sampling of methylene chloride
(Refs. 65, 70, 75, 78). According to the commenters, it is common
practice within the industrial hygiene community to have analyses
performed by American Industrial Hygiene Association (AIHA) accredited
labs (Refs. 65, 78). A commenter further reasoned that because labs in
the United States are usually certified by ISO/IEC 17025 Testing and
Calibration Laboratories, a standard that differs from the proposed
GLP, they recommended that provisions of monitoring results and
recordkeeping in the final rule be allowed from any accredited
laboratory, without regard to a specific type (Ref. 65).
EPA agrees with the commenter that the WCPP for methylene chloride
is incompletely served by solely relying on the GLP standard initially
put forth in the 2023 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. 70, 85),
EPA is inclined to broaden 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. Therefore, EPA is finalizing a
provision that expands monitoring results and associated recordkeeping
requirements to any accredited lab including GLP, AIHA (AIHA Laboratory
Accreditation Programs (LAP), LLC Policy Module 2A/B/E of Revision
17.3), or other analogous industry-recognized program.
Another commenter noted that EPA omitted a provision from the OSHA
methylene chloride standard that they stated is important for air
monitoring and protections to potentially exposed persons. More
specifically, the commenter referred to 29 CFR 1910.1052(b) where OSHA
defines employee exposure to mean that airborne concentration of
methylene chloride that either occurs, or would occur, in the absence
of respiratory protection (Ref. 90). 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 methylene chloride 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 methylene chloride, thus
empowering owners or operators to appropriately consider the hierarchy
of controls.
F. Other Changes
EPA is also adding a definition of ``article'' and a definition of
``product'' to the definitions that EPA proposed to add to 40 CFR part
751, subpart A. In order to provide additional clarity on the de
minimis provision in this final rule, as well as the provisions
relating to the refinishing of wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural, or historic value, EPA is
incorporating into subpart A the definitions of ``article'' and
``product'' that already exist in 40 CFR part 751, subpart E. The
article definition is consistent with other article definitions in
regulations under TSCA. The product definition makes it clear that when
EPA uses the term ``product'' in this regulation, EPA is not referring
to articles. These definitions are consistent with the usage of these
terms in previously promulgated TSCA regulations, including the 2021
regulation on 2,4,6-tris(tert-butyl)phenol (86 FR 866, January 6, 2021
(FRL-10018-90), which incorporated the same definitions into 40 CFR
part 751, subpart B, and the 2019 regulation prohibiting the
manufacture, processing, and distribution of methylene chloride for use
in consumer paint and coating removers (84 FR 11420, March 27, 2019)
(FRL-9989-29), which does not refer to articles, but uses the term
``product'' to refer to methylene chloride and mixtures containing
methylene chloride. EPA is also promulgating the proposed definitions
of ``ECEL'' and ``EPA STEL'' in 40 CFR 751.103 rather than in subpart A
to allow EPA the flexibility to tailor the definitions to address
unique circumstances with future chemicals. Lastly, EPA has revised its
proposed description of industrial and commercial use as a laboratory
chemical condition of use to provide additional clarity as suggested by
a commenter (Ref. 77). The revised description appears in Unit
IV.B.1.c.iv.
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 methylene chloride 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.C., this final rule prohibits commercial use of paint and
coating removal products that contain methylene chloride and are used
in furniture refinishing (though a subset of this use has a delayed
compliance date, as described in Unit III.B.1.), and also adhesives and
sealants that contain methylene chloride (also with a subset of this
use having a delayed compliance date as described in Unit III.B.2.). To
the extent that a court were to find that EPA lacked substantial
evidence to support its prohibition of paint and coating removal
products used in furniture refinishing 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 adhesives and
sealants unless the specific issue also applies to the particular facts
associated with adhesives and sealants. This is reflected in the
structure of the rule, which describes the specific prohibitions
separately by compliance date.
As another example, for commercial use of methylene chloride in
paint and coating removal products used in furniture refinishing and
industrial and commercial use of methylene chloride as a laboratory
chemical, EPA took
[[Page 39272]]
different risk management approaches--prohibition for paint and coating
removal products used in furniture refinishing (though a subset of this
use has a delayed compliance date, as described in Unit III.B.1.) and
application of the WCPP for the industrial and commercial use of
methylene chloride as a laboratory chemical. To the extent that a court
were to find a legal issue with EPA's approach to the WCPP, impacting
industrial and commercial use of methylene chloride as a laboratory
chemical, it would have no bearing on EPA's decision to prohibit paint
and coating removal products used in furniture refinishing, 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.
In some circumstances, EPA also intends certain portions of the
WCPP to be severable from the rest of the WCPP. For example, EPA
intends the methods of compliance with the ECEL and EPA STEL described
in paragraph (e)(1) to function somewhat independently. The provisions
in paragraph (e)(1)(i) through (iii) are generally applicable to all
impacted owners or operators. However, paragraph (e)(1)(iv) is
specifically applicable to a scenario where the Department of Defense,
based on ongoing or planned military construction that requires
Congressional authorization and appropriation prior to start of
construction, may need additional time to comply with the requirements
of paragraph (e)(1)(i). Since the Department of Defense is also covered
by the more general provision in paragraph (e)(1)(i), if a court were
to find a legal issue with EPA's decision to provide the independently
functioning paragraph (e)(1)(iv) to provide the Department of Defense
with additional time in a particular circumstance, it would not have
any bearing on EPA's broader regulatory approach reflected in paragraph
(e)(1)(i) through (iii) to strike that provision.
EPA also intends all TSCA section 6(a) risk management elements in
this rule to be severable from 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).
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 will initiate a notice of proposed rulemaking for public comment on
this topic and will add this to the Spring 2024 Regulatory Agenda.
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 methylene chloride 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 methylene chloride even if being manufactured, processed, or
distributed in commerce solely for export from the United States
because EPA has determined that methylene chloride presents an
unreasonable risk to health within the United States. A commenter
expressed concern that distribution for export would be prohibited
under the 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 (Ref. 91).
Because distribution in commerce did not contribute to EPA's
unreasonable risk determination for methylene chloride, and because
this final rule permits manufacturing and processing for various uses
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.C., EPA's final rule is adopting a de
minimis threshold of 0.1% to account for impurities and the unintended
presence of methylene chloride. In other words, the provisions of this
rulemaking only apply when methylene chloride 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.
7).
B. Workplace Chemical Protection Program (WCPP)
1. Applicability
EPA is finalizing the WCPP for the conditions of use for which it
was proposed, as well as for additional conditions of use for which
either prohibition was proposed, or for which the WCPP was proposed
only for a sub-set of uses within the condition of use. EPA has not
removed from the WCPP any conditions of use proposed to be included.
EPA's descriptions of changes from the 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 proposed rule (88 FR
28284, May 3, 2023) (FRL-8155-02-OCSPP). EPA is additionally requiring
that uses receiving an exemption under TSCA section 6(g), as outlined
in Unit IV.E., comply with the WCPP.
[[Page 39273]]
EPA is finalizing the WCPP for the following conditions of use:
domestic manufacturing; import; processing as a reactant; processing
for incorporation into a formulation, mixture, or reaction product;
processing in repackaging; processing in recycling; industrial and
commercial use as a laboratory chemical; industrial and commercial use
as a paint and coating remover from safety critical, corrosion-
sensitive components of aircraft and spacecraft; industrial or
commercial use as a bonding agent for solvent welding; industrial and
commercial use as a processing aid; industrial and commercial use for
plastic and rubber products manufacturing; industrial and commercial
use as a solvent that becomes part of a formulation or mixture, where
that formulation or mixture will be used inside a manufacturing
process, and the solvent (methylene chloride) will be reclaimed; and
disposal. This unit provides a description of the uses subject to the
WCPP in order to assist with compliance.
a. Manufacturing (Includes Import)
i. Domestic Manufacturing
This condition of use refers to manufacturing, or producing, a
chemical substance within the United States (including manufacturing
for export). Manufacture includes the extraction of a component
chemical substance from a previously existing chemical substance or
complex combination of chemical substances.
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
This condition of use refers to processing methylene chloride in
chemical reactions for the manufacturing of another chemical substance
or product, e.g., difluoromethane, also known as HFC-32, which is used
in fluorocarbon blends for refrigerants, and bis-2,2-dinitropropyl-
acetal/formal.
ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction
Product
This condition of use refers to when methylene chloride is added to
a product (or product mixture) prior to further distribution of the
product.
iii. Processing: Repackaging
This condition of use refers to the preparation of methylene
chloride for distribution in commerce in a different form, state, or
quantity. This includes transferring the chemical from a bulk container
into smaller containers.
iv. Processing: 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 on-site 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.
c. Industrial and Commercial Uses
i. Industrial and Commercial Use as a Solvent That Becomes Part of a
Formulation or Mixture, Where That Formulation or Mixture Will Be Used
Inside a Manufacturing Process, and the Solvent (Methylene Chloride)
Will Be Reclaimed
This condition of use refers to industrial or commercial use of
methylene chloride added to a product (or product mixture) in an
industrial or commercial setting for use inside a closed-loop
manufacturing process, where the solvent will be reclaimed and reused.
ii. Industrial and Commercial Use as a Processing Aid
This condition of use refers to the industrial or commercial use of
methylene chloride 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. Processing agents do not become a part of the
reaction product and are not intended to affect the function of a
substance or article created. For methylene chloride, the use as a
processing aid condition of use also encompasses use of methylene
chloride as a heat transfer fluid, and use in the manufacture of
battery separators. Use of methylene chloride as a processing aid also
refers to use of methylene chloride in blending powder for flashtube
and ignition booster pellets and as a de-sensitizer for nitroglycerine
shipment. Additionally, the use of methylene chloride in a closed-loop
chiller system that supports performance of FAA-required aviation fuel
testing, these are considered under the condition of use industrial and
commercial use as a processing aid. The analogous use of methylene
chloride in a chiller system in the Department of Defense McKinley
Climatic Laboratory would likewise be considered industrial and
commercial use as a processing aid. (EPA notes that these chiller uses
were identified under ``Industrial and commercial use as a laboratory
chemical'' under the proposed rule. However, EPA has determined they
are more accurately categorized under the condition of use ``industrial
and commercial use as a processing aid,'' as with other heat transfer
fluid uses).
iii. Industrial and Commercial Use as a Laboratory Chemical
This condition of use refers to the industrial or commercial use of
methylene chloride in a laboratory process or in specialized laboratory
equipment for instrument calibration/maintenance chemical analysis,
chemical synthesis, extracting and purifying other chemicals,
dissolving other substances, executing research, development, test and
evaluation methods, and similar activities, such as use as a solvent,
reagent, analytical standard, or other experimental use. For the
purposes of this rulemaking, EPA emphasizes that industrial and
commercial use of methylene chloride as a laboratory chemical applies
to research, government, and academic institutions, as well as to
industrial and commercial laboratories. Laboratory use of methylene
chloride includes Department of Defense sampling, examining, and
testing of solid propellants, detail specifications of nitrocellulose,
and laboratory analysis for TNT conformity with TNT acidity
requirements.
iv. Industrial and Commercial Use for Plastic and Rubber Products
Manufacturing
This condition of use refers to the industrial or commercial use of
methylene chloride in the manufacture and processing of plastic and
rubber products, including in interfacial polymerization for
polycarbonate plastic manufacturing.
v. Industrial and Commercial Use as a Paint and Coating Remover From
Safety Critical, Corrosion-Sensitive Components of Aircraft and
Spacecraft
This condition of use refers to the industrial or commercial use of
methylene chloride or methylene chloride-containing products applied to
corrosion-sensitive surfaces to remove paint, coatings, and other
finishes and
[[Page 39274]]
to clean the underlying surface in safety critical components of
aircraft and spacecraft.
vi. Industrial or Commercial Use as a Bonding Agent for Solvent Welding
This condition of use refers to the industrial or commercial use of
methylene chloride or a solvent blend including methylene chloride to
chemically bond polymer substrates including, but not limited to,
acrylic or polycarbonate, creating an airtight, waterproof, and in some
cases seamless joint.
d. Disposal
This condition of use refers to the process of disposing generated
waste streams of methylene chloride that are collected either on-site
or transported to a third-party site for disposal.
2. Overview
A WCPP encompasses inhalation exposure thresholds, includes
monitoring and recordkeeping requirements to verify that those
thresholds are not exceeded, and may include other components, such as
dermal protection, 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. In the case of methylene chloride, meeting the EPA exposure
limit thresholds for certain occupational conditions of use would
address the unreasonable risk to potentially exposed persons from
inhalation exposure.
EPA is finalizing these requirements to begin taking effect on May
5, 2025 for the private sector and on November 9, 2026 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, at which point entities would be required to conduct
initial monitoring (as described in Unit IV.B.4.b.). Additionally, EPA
requires that each owner or operator ensure that the airborne
concentration of methylene chloride does not exceed the ECEL or EPA
STEL for all potentially exposed persons no later than August 1, 2025
for the private sector, or no later than February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government. Implementation of any needed exposure controls based on
initial monitoring and development of an exposure control plan would be
required no later than October 30, 2025, for the private sector, or May
10, 2027 for Federal agencies and Federal contractors acting for or on
behalf of the Federal Government (as described in Unit III.D.1.).
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where methylene chloride is present and who may be
exposed to methylene chloride under the conditions of use for which a
WCPP would apply. One important reason to define a potentially exposed
person for the purposes of a WCPP as any person who may be exposed in
the workplace is to emphasize the broad scope of exposures which must
be categorized when implementing a WCPP. EPA notes that this definition
is intended to apply only in the context of risk management, and
specifically in the context of a WCPP (e.g., workers directly using the
chemical, workers in the vicinity of the use, students in a laboratory
setting). The term is not intended as a replacement for the term
Potentially Exposed or Susceptible Subpopulation as defined by TSCA
section 3(12). EPA additionally recognizes that other individuals or
communities may be exposed to methylene chloride as consumers, members
of fenceline communities, or members of the general population, which
is separate and apart from those potentially exposed for the purposes
of the regulatory requirements of the WCPP. In those instances, where
regulatory requirements address exposures unrelated to a WCPP EPA would
use distinct terminology to refer to those other populations. EPA
requires a comprehensive WCPP to address the unreasonable risk from
methylene chloride to workers directly handling the chemical or in the
area where the chemical is being used. Similarly, the 2020 Risk
Evaluation for Methylene Chloride (Ref. 1) did not distinguish between
employers, contractors, or other legal entities or businesses that
manufacture, process, distribute in commerce, use, or dispose of
methylene chloride. For this reason, EPA uses the term ``owner or
operator'' to describe the entity responsible for implementing the WCPP
in any workplace where an applicable condition of use identified in the
following paragraph and subject to the WCPP is occurring. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace. While owners or operators remain responsible for
ensuring compliance with the WCPP requirements in the workplace, they
may contract with others to provide training or implement a respiratory
protection program, for example.
EPA emphasizes that this approach is essential for addressing the
unreasonable risk presented by methylene chloride, including to
individuals who may not be covered by OSHA requirements, such as
university students, 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, section 113 of the Clean Air Act (CAA), 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. 92). The 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 methylene
chloride condition of use is ongoing and where implementation of the
WCPP 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
[[Page 39275]]
with, the WCPP requirements in practice.
EPA's implementation of the ECEL as part of a WCPP aligns with, to
the extent possible, certain elements of the existing OSHA standard for
regulating methylene chloride under 29 CFR 1910.1052. However, EPA is
finalizing new, lower exposure thresholds, derived from the TSCA 2020
Risk Evaluation for Methylene Chloride, while aligning with existing
requirements wherever possible (Refs. 1, 93). For methylene chloride,
this final rule will eliminate the unreasonable risk from methylene
chloride 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 methylene chloride under
the conditions of use listed earlier in this unit would no longer be
presented.
This unit includes a summary of the WCPP, including a description
of the finalized exposure limits including an ECEL, ECEL action level,
and EPA STEL; implementation requirements including monitoring
requirements; a description of potential exposure controls, including
engineering controls, administrative controls, and PPE as it relates to
dermal protections and respirator selection; and additional finalized
requirements for recordkeeping, workplace participation, and
notification in accordance with the hierarchy of controls. This unit
also describes compliance timeframes revised from the 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), EPA Action Level, Short-
Term Exposure Limit (STEL)
EPA is finalizing as proposed an ECEL under TSCA section 6(a) of 2
ppm (8 mg/m\3\) as an 8-hour TWA based on the chronic non-cancer human
equivalent concentration for liver toxicity. EPA has determined that
ensuring exposures remain at or below the 8-hour TWA ECEL of 2 ppm will
eliminate the unreasonable risk of injury to health resulting from
acute and chronic inhalation exposures for certain occupational
conditions of use of methylene chloride (Ref. 93).
If ambient exposures are kept at or below the 8-hour TWA ECEL of 2
ppm and at or below the 15-minute TWA EPA STEL of 16 ppm also finalized
in this unit, a potentially exposed person will be protected against
the effects described in this unit, including effects resulting from
acute exposure (central nervous system depression), chronic non-cancer
effects (liver toxicity), and cancer. Using the TWA concept, as long as
the 8-hr TWA or 15-min EPA STEL are not exceeded, airborne
concentrations could temporarily exceed the ECEL.
EPA is finalizing as proposed an ECEL action level at half of the
8-hour ECEL, or 1 ppm (4 mg/m\3\) as an 8-hour TWA. Below the ECEL
action level, certain compliance activities, such as periodic
monitoring, would be required once every five years as described
further in this unit. In this way, EPA's WCPP for methylene chloride
aligns with the familiar framework that is in place in 29 CFR 1910.1052
and many other occupational settings where the action level is half the
relevant occupational exposure level. OSHA explained that its decision
to set the action level at one-half the PEL was based on its successful
experience using this fraction as the action level in many standards
(e.g., arsenic, ethylene oxide, vinyl chloride and benzene); for most
workplaces, the agency found that variability in employee exposures is
normally such that an action level set at one-half the TWA PEL is
appropriate (Ref. 94).
In addition to the 8-hour TWA ECEL, EPA is finalizing as proposed a
STEL of 16 ppm (57 mg/m3) as a 15-minute TWA. This STEL is based on the
non-cancer endpoint of central nervous system depression resulting from
acute exposures. EPA has also determined that ensuring exposures remain
at or below the EPA STEL will eliminate the unreasonable risk of injury
to health from methylene chloride due to acute inhalation exposures in
an occupational setting. EPA is finalizing the EPA STEL as a 15-minute
TWA for the protection of potentially exposed persons to methylene
chloride for shorter durations and at higher concentrations that fall
outside the parameters of the ECEL 8-hour TWA.
In summary, EPA is finalizing as proposed that owners or operators
must ensure the airborne concentration of methylene chloride within the
personal breathing zone of potentially exposed persons remains at or
below 2 ppm as an 8-hour TWA ECEL, with an action level finalized as 1
ppm as an 8-hour TWA. OSHA defines the personal breathing zone 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. 95).
EPA is finalizing as proposed that owners or operators must also ensure
the airborne concentration of methylene chloride within the personal
breathing zone of potentially exposed persons remains at or below a 15-
minute TWA, or EPA STEL, of 16 ppm. EPA is finalizing the ECEL and EPA
STEL for certain occupational conditions of use to ensure that no
person is exposed to inhalation of methylene chloride 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, ECEL action level, and EPA
STEL because of viable detection limits and analytical methods of
methylene chloride for monitoring devices that are widely available in
commerce, currently in use, and approved by OSHA and NIOSH, which
generally range from 0.2 to 0.4 ppm (Ref. 93). EPA also recognizes that
analytical methods for monitoring are available from OSHA and NIOSH
that are capable of detecting the exposure limits with a higher degree
of accuracy (Refs. 96, 97).
4. Monitoring Requirements
a. In General
Initial monitoring for methylene chloride 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 this
unit 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 as proposed its requirement that owners or
operators determine each potentially exposed person's exposure by
taking a personal breathing zone air sample, or by taking personal
breathing zone air samples that are representative of each potentially
exposed person's exposure. Owners or operators will be permitted to
consider personal breathing zone air samples to be representative of
each potentially
[[Page 39276]]
exposed person's exposure when one or more samples are taken for at
least one potentially exposed person in each job classification in a
work area during every work shift, and the person sampled is expected
to have the highest methylene chloride exposure; or when one or more
samples are taken which indicate the highest likely 15-minute exposures
during such operations for at least one potentially exposed person in
each job classification in the work area during every work shift, and
the person sampled is expected to have the highest methylene chloride
exposure. 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 methylene chloride without taking respiratory
protections into account as sampling is being performed. These final
requirements align with the approach taken for characterization of
employee exposure in the 1997 OSHA standard for methylene chloride (see
29 CFR 1910.1052(b), (d)(1)(i) and (ii)). EPA is also finalizing
requirements that the owner or operator ensure, for initial and
periodic monitoring, that their exposure monitoring methods are
accurate to a confidence level of 95% and are within (plus or minus)
25% of airborne concentrations of methylene chloride above the 8-hour
TWA ECEL or the 15-minute TWA EPA STEL, or within (plus or minus) 35%
for airborne concentrations of methylene chloride at or above the ECEL
action level but at or below the 8-hour TWA ECEL. These requirements,
including the 35%, would align with the approach taken in the 1997 OSHA
standard for methylene chloride (see 29 CFR 1910.1052(d)(1)(iii)).
Though EPA is finalizing the accuracy range as proposed, EPA recognizes
that more recent monitoring methods and technologies currently exist
and allow for greater accuracy, and thus a narrower accuracy range for
monitoring results such as the NIOSH 3900 method and the OSHA 1025
method (Refs. 96, 97). 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.
b. Initial Exposure Monitoring
Under the final regulation, each owner or operator of a facility in
the private sector that is engaged in one or more of the conditions of
use listed earlier in Unit IV.B.1. will be required to perform initial
exposure monitoring within 360 days after publication of the final rule
to determine the extent of exposure of potentially exposed persons to
methylene chloride. In consideration of public comments, EPA has
changed the timeframe for completion of initial monitoring from 180
days after publication of the final rule to 360 days after publication
of the final rule in the Federal Register. As discussed in Unit
III.D.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, adopt new exposure controls (such as engineering controls,
administrative controls, and/or a respiratory protection program), or
to continue or discontinue certain compliance activities such as
periodic monitoring. 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 of the most highly exposed persons in the workplace.
Additionally, EPA expects that owners and operators will conduct
initial exposure monitoring representative to determine the extent of
methylene chloride exposure for potentially exposed persons. EPA
understands that certain tasks may occur less frequently or may reflect
upset conditions (for example, due to malfunction).
EPA also recognizes that the values for the ECEL action level and
EPA STEL may mean that some owners or operators currently in compliance
with the OSHA standard would have to establish a new monitoring
baseline for EPA's Final Rule for methylene chloride. Aligning with the
existing OSHA standard (29 CFR 1910.1052(d)(2)) to the extent possible,
EPA is finalizing as proposed that an owner or operator may temporarily
forgo initial exposure monitoring if:
(i) An owner or operator could provide EPA with objective data
generated during the last five years demonstrating that methylene
chloride cannot be released in the workplace in airborne concentrations
at or above the ECEL action level (1-ppm 8-hour TWA) and above the EPA
STEL (16 ppm 15-minute TWA), and that the data represent the highest
methylene chloride exposures likely to occur under reasonably
foreseeable conditions of manufacturing, processing, use, or disposal,
as applicable, including handling of methylene chloride during those
activities. Owners or operators who rely on objective data must
maintain records including the use of methylene chloride evaluated, the
source of the objective data, the measurement methods, measurement
results, and measurement analysis of the use of methylene chloride, and
any other data relevant to the operations, processes, or person's
exposure. The oldest objective data used to demonstrate that exposures
are below the ECEL action level and EPA STEL will indicate the
beginning of the five-year cycles of recurring exposure monitoring as
described in Unit IV.B.4.b.;
(ii) Where potentially exposed persons are exposed to methylene
chloride for fewer than 30 days per year and the owner or operator has
measurements by direct-metering devices that give immediate results and
provide sufficient information regarding potentially exposed persons'
exposures to determine and implement the control measures that are
necessary to reduce exposures to below the ECEL action level and EPA
STEL.
As described in more detail later in this unit, 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. Additionally, if a facility
were to commence one or more conditions of use listed in Unit IV.B.1.
after May 5, 2025, the owner or operator must perform an initial
exposure monitoring within 30 days of commencing the condition(s) of
use and would be required to conduct periodic monitoring in accordance
with table 1 in Unit IV.B.4.c. For facilities that commence one or more
conditions of use listed in Unit IV.B.1. after May 5, 2025, the owner
or operator must ensure that the airborne concentration of methylene
chloride does not exceed the
[[Page 39277]]
ECEL or EPA STEL for all potentially exposed persons within 90 days of
the initial exposure monitoring.
c. Periodic Exposure Monitoring
EPA's final rule is aligned with elements of the existing OSHA
standard (29 CFR 1910.1052(d)(3)) to the extent possible. Based on the
results from the initial exposure monitoring, EPA is finalizing as
proposed the following periodic monitoring for owners or operators.
These finalized requirements are also outlined in table 1.
If the initial exposure monitoring is below the ECEL
action level (1 ppm 8-hour TWA) and at or below the EPA STEL (16 ppm
15-minute TWA), the ECEL and EPA STEL periodic monitoring would be
required once every five years, except when additional exposure
monitoring (Unit IV.B.4.e.) measurements require it.
If the initial exposure monitoring concentration is below
the ECEL action level (1 ppm 8-hour TWA) and above the EPA STEL (16 ppm
15-minute TWA), the ECEL periodic monitoring would be required once
every five years or when additional monitoring (Unit IV.B.4.e.)
measurements require it, but EPA STEL periodic monitoring would be
required every three months.
If the initial exposure monitoring concentration is at or
above the ECEL action level (1 ppm 8-hour TWA) and at or below the ECEL
(2 ppm 8-hour TWA), and at or below the EPA STEL (16 ppm 15-minute
TWA), the ECEL periodic monitoring would be required every six months.
If the initial exposure monitoring concentration is at or
above the ECEL action level (1 ppm 8-hour TWA) and at or below the ECEL
(2 ppm 8-hour TWA), and above the EPA STEL, the ECEL periodic
monitoring would be required every six months and EPA STEL periodic
monitoring would be required every three months.
If the initial exposure monitoring concentration is: Above
the ECEL (2 ppm 8-hour TWA) and below, at, or above the EPA STEL (16
ppm 15-minute TWA), the ECEL and EPA STEL periodic monitoring would be
required every three months.
The owner or operator would be permitted to transition the
ECEL periodic exposure monitoring frequency from every three months to
every six months if two consecutive monitoring events taken at least
seven days apart indicate that the potential exposure has decreased to
or below the ECEL, but at or above the ECEL action level.
The owner or operator would be permitted to transition
from the ECEL periodic exposure monitoring frequency from every six
months to once every five years if two consecutive monitoring events
taken at least seven days apart indicate that the potential exposure
has decreased below the ECEL action level and at or below the EPA STEL.
The second consecutive monitoring event would delineate the new date
from which the next five-year periodic exposure monitoring must occur.
In addition to the periodic monitoring standards described earlier,
EPA is finalizing two additional provisions:
Based on its monitoring results, if the owner or operator
would be required to monitor either the ECEL or EPA STEL in a three-
month interval but does not engage in any of the conditions of use
listed in Unit IV.B.1. for which the WCPP is finalized over the
entirety of those three months, the owner or operator would be
permitted to forgo the upcoming periodic monitoring event. However,
documentation of cessation of use of methylene chloride would be
required, and initial monitoring would be required when the owner or
operator resumes or starts any of the conditions of use listed in Unit
IV.B.1. for which the WCPP is finalized.
Based on its monitoring results, if the owner or operator
would be required to monitor the ECEL in a six-month interval but does
not engage in any of the conditions of use listed in Unit IV.B.1. for
which the WCPP is finalized over the entirety of those six months, the
owner or operator would be permitted to forgo the upcoming periodic
monitoring event. However, documentation of cessation of use of
methylene chloride would be required, and initial monitoring would be
required when the owner or operator resumes or starts any of the
conditions of use listed in Unit IV.B.1. for which the WCPP is
finalized.
Periodic monitoring would be required to occur at least
once every five years if methylene chloride is present.
Table 1--Periodic Monitoring Requirements Based on Initial Exposure
Monitoring Results
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If the initial exposure monitoring ECEL and EPA STEL periodic
concentration is below the ECEL action monitoring at least once every
level and at or below the EPA STEL. 5 years.
If the initial exposure monitoring ECEL periodic monitoring at
concentration is below the ECEL action least once every 5 years, and
level and above the EPA STEL. EPA STEL periodic monitoring
required every 3 months.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months.
action level and at or below the ECEL;
and at or below the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months and EPA STEL periodic
action level and at or below the ECEL; monitoring every 3 months.
and above the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is above the ECEL and 3 months and EPA STEL periodic
below, at, or above the EPA STEL. monitoring every 3 months.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency from
indicate that potential exposure has every 3 months to every 6
decreased from above the ECEL to at or months.
below the ECEL, but at or above the
ECEL action level.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency every 6
indicate that potential exposure has months to once every 5 years.
decreased to below the ECEL action The second consecutive
level and at or below the EPA STEL. monitoring event will
delineate the new date from
which the next 5-year periodic
exposure monitoring must
occur.
If the owner or operator engages in any The owner or operator may forgo
of the conditions of use for which the upcoming periodic
WCPP is finalized and is required to monitoring event. However,
monitor either the ECEL or EPA STEL in documentation of cessation of
a 3-month interval, but does not manufacture, processing, use,
engage in any of those conditions of or disposal of methylene
use for the entirety of the 3-month chloride must be maintained,
interval. and initial monitoring would
be required when the owner or
operator resumes or starts any
of the conditions of use for
which the WCPP is finalized.
[[Page 39278]]
If the owner or operator engages in any The owner or operator may forgo
of the conditions of use for which the upcoming periodic
WCPP is finalized and is required to monitoring event. However,
monitor the ECEL in a 6-month documentation of cessation of
interval, but does not engage in any manufacture, processing, use,
of those conditions of use for the or disposal of methylene
entirety of the 6-month interval. chloride must be maintained,
and initial monitoring would
be required when the owner or
operator resumes or starts any
of the conditions of use for
which the WCPP is finalized.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
discussed in Unit IV.B.4.e.
d. Minimum Frequency of Exposure Monitoring
EPA is finalizing the proposed requirement that a monitoring event
be conducted at a minimum frequency of every five years by owners or
operators using methylene chloride for any condition of use subject to
the WCPP. To better reflect the periodic nature of such monitoring, the
final rule describes it as a periodic monitoring requirement, rather
than a requirement to re-conduct initial exposure monitoring every five
years, as it was described in the proposed rule. EPA emphasizes that
this monitoring must represent all potentially exposed persons in the
workplace. Moreover, EPA is finalizing that monitoring requirements can
only be made less frequent based on the results of the initial exposure
monitoring or the periodic exposure monitoring outlined under Units
IV.B.4.b. and IV.B.4.c., respectively.
e. Additional Exposure Monitoring
EPA is finalizing the requirement that the owner or operator
complying with the WCPP must carry out an additional exposure
monitoring after any change that may reasonably be expected to
introduce additional sources of exposure, or result in a change in
exposure levels, to methylene chloride. Examples include changes in the
production, production volume, use rate, process, control equipment, or
work practices that may reasonably be anticipated to cause additional
sources of exposure or result in increased exposure levels to methylene
chloride; and start-up, shutdown, or malfunction of the facility or
facility equipment that may reasonably be anticipated to cause
additional sources of exposure or result in increased exposure levels
to methylene chloride. This additional exposure monitoring event may
result in increased frequency of periodic monitoring. The required
additional exposure monitoring should not delay implementation of any
necessary cleanup or other remedial action to reduce the exposures to
potentially exposed persons.
5. Exposure Control Plan
EPA is finalizing its requirement that entities implementing the
WCPP use elimination and substitution, followed by the use of
engineering controls, administrative controls, and work practices prior
to requiring the use of PPE (i.e., respirators) as a means of
controlling inhalation exposures below EPA's ECEL or STEL, in
accordance with the hierarchy of controls (Ref. 98). If an owner or
operator chooses to replace methylene chloride 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 unreasonable risks 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.
EPA is finalizing its requirement that the owner or operator
demarcate any area where airborne concentrations of methylene chloride
are reasonably expected to exceed the ECEL or the EPA STEL. In response
to comments requesting more clarity regarding how regulated areas must
be demarcated, EPA has incorporated the language from the analogous
OSHA requirement 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 methylene chloride within the regulated area. This
can be accomplished using administrative controls, e.g., highly visible
signifiers, in multiple languages as appropriate (e.g., when
potentially exposed persons who are primarily Spanish-speaking are
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.
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 or EPA STEL. If efforts of
elimination, substitution, engineering controls, and administrative
controls are not sufficient to reduce exposures to or below the ECEL or
EPA STEL for all potentially exposed persons in the workplace, EPA
requires that the owner or operator use feasible controls to reduce
methylene chloride concentrations in the workplace to the lowest levels
achievable and supplement these controls with respiratory protection
and PPE as needed to achieve the ECEL before potentially exposed
persons enter a regulated area. In such cases, EPA requires that the
owner or operator provide potentially exposed persons reasonably likely
to be exposed to methylene chloride by inhalation to concentrations
above the ECEL or EPA STEL with respirators affording sufficient
protection against inhalation risk and appropriate training on the
proper use of such respirators, to ensure that their exposures do not
exceed the ECEL or EPA STEL, as described in this unit. As part of the
training requirement, the owner or operator is required to provide
information and comprehensive training in an understandable manner
(i.e., plain language), considering factors such as the skills required
to perform the work activity and the existing skill level of the staff
performing the work, and in multiple languages as appropriate (e.g.,
based on languages spoken by potentially exposed persons) to
potentially exposed persons. This training must be provided prior to or
at the time of initial assignment to a job involving potential exposure
to methylene chloride. Furthermore, EPA also requires that the owner or
operator
[[Page 39279]]
document their efforts in using elimination, substitution, engineering
controls, and administrative controls to reduce exposure to or below
the ECEL or EPA STEL in an exposure control plan.
EPA is finalizing its requirement that the owner or operator
include and document in the exposure control plan or through any
existing documentation of the facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards, the following:
Identification in the exposure control plan of available
exposure controls and rationale for using or not using available
exposure controls in the following sequence (i.e., elimination and
substitution, then engineering controls and administrative controls) to
reduce exposures in the workplace to either at or below the ECEL or to
the lowest level achievable, and the exposure controls selected based
on feasibility, effectiveness, and other relevant considerations;
For the exposure controls not selected, document the
efforts identifying why these are not feasible, not effective, or
otherwise not implemented;
A description of actions the owner or operator must take
to implement exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other steps taken;
A description of regulated areas, how they are demarcated,
and persons authorized to enter the regulated areas;
A description of activities conducted by the owner or
operator to review and update the exposure control plan to ensure
effectiveness of the exposure controls, identify any necessary updates
to the exposure controls, and confirm that all persons are properly
implementing the exposure controls; and
An explanation of the procedures for responding to any
change that may reasonably be expected to introduce additional sources
of exposure to methylene chloride, or otherwise result in increased
exposure to methylene chloride, including procedures for implementing
corrective actions to mitigate exposure to methylene chloride.
Under this final rule, owners or operators are prohibited from
using rotating work schedules to comply with the ECEL 8-hour TWA.
Owners or operators must maintain the effectiveness of any engineering
controls, administrative controls, or work practices instituted as part
of the exposure control plan. They must also review and update the
exposure control plan as necessary, but at least every five years, to
reflect any significant changes in the status of the owner or
operator's approach to compliance with the exposure control
requirements. EPA intends that the exposure control plan identify the
available exposure controls and, for the exposure controls not
selected, document the efforts identifying why these are not feasible,
not effective, or otherwise not implemented. For entities for which
significant amounts of time are needed to verify suitability of
alternatives or procure funds or authorization for additional
engineering controls, for example, EPA expects that as those controls
become available the exposure control plan would be updated
accordingly. EPA requires that the exposure control plan be revisited
under certain conditions (and at least every five years) and encourages
updates as more sophisticated controls are available.
This final rule requires owners or operators to make the exposure
control plan and associated records available to potentially exposed
persons, at a reasonable time, place, and manner, within 15 working
days of receiving a request. Owners or operators must also provide
notice of the availability of the plan and associated records to
potentially exposed persons.
6. Personal Protective Equipment (PPE)
Where elimination, substitution, engineering, and administrative
controls are not feasible or sufficiently protective to reduce the air
concentration to or below the ECEL, or if inhalation exposure above the
ECEL is still reasonably likely, EPA is finalizing its minimum
respiratory PPE requirements based on an owner or operator's measured
air concentration for one or more potentially exposed persons and the
level of PPE needed to reduce exposure to or below the ECEL. In those
circumstances, EPA is finalizing its requirement that the owner or
operator also comply with OSHA's General Requirements for PPE standard
at 29 CFR 1910.132 for application of a PPE program. EPA is also
requiring that the owner or operator comply with 29 CFR 1910.134 for
proper use, maintenance, fit-testing, and training of respirators.
a. Required Dermal Protection
EPA is finalizing the provision and use of chemically resistant
gloves in combination with specific activity training (e.g., glove
selection (type, material), expected duration of glove effectiveness,
actions to take when glove integrity is compromised, storage
requirements, procedure for glove removal and disposal, chemical
hazards) for tasks where dermal exposure can be expected to occur.
Additionally, EPA is requiring that owners and operators comply with
relevant sections of the methylene chloride OSHA standard to minimize
and protect potentially exposed persons from dermal exposure, including
29 CFR 1910.1052(h) and (i). Additional information related to choosing
appropriate gloves can be found in the NIOSH Hazard Alert (Ref. 99) and
in appendix F of the 2020 Risk Evaluation for Methylene Chloride (Ref.
1).
b. Required Respiratory Protection
EPA is finalizing the following requirements for respiratory
protection, based on the exposure monitoring concentrations measured as
an 8-hour TWA that exceeds the ECEL (2 ppm) or 15-minute TWA that
exceeds the EPA STEL (16 ppm); see also the following table (table 2).
These requirements apply after all other feasible controls are
exhausted or proven ineffective to control inhalation exposure
(including elimination, substitution, engineering controls, and
administrative controls in accordance with the hierarchy of controls).
EPA is finalizing its minimum respiratory protection requirements, such
that any respirator affording the same or a higher degree of protection
than the following proposed requirements may be used. Under this final
regulatory action, air-purifying respirators (in contrast to air-
supplied respirators) are not permitted as a means of mitigating
methylene chloride exposure, as they do not provide adequate
respiratory protection against this chemical (Ref. 100). Additionally,
EPA acknowledges that there may be respirator limitations dependent
upon the nature of the activity in which methylene chloride is used
(e.g., a decreased range of motion or access to a small space could
hinder PPE use). Nevertheless, owners and operators must provide
respirators that are protective of the measured exposure concentration
after all other feasible controls are considered.
If the measured exposure concentration is at or below the
ECEL (2 ppm 8-hour TWA) and EPA STEL (16 ppm 15-minute TWA):
Respiratory protection is not required.
If the measured exposure concentration is above 2 ppm and
less than or equal to 50 ppm (25 times the ECEL): The required
respirator protection is any NIOSH Approved[supreg] SAR or airline
respirator in a continuous-flow mode equipped with a
[[Page 39280]]
loose-fitting facepiece or helmet/hood (APF 25).
If the measured exposure concentration is above 50 ppm and
less than or equal to 100 ppm (50 times the ECEL): The required
respirator protection is: (i) Any NIOSH Approved[supreg] SAR or airline
respirator in a demand mode equipped with a full facepiece (APF 50); or
(ii) Any NIOSH Approved[supreg] SCBA in demand-mode equipped with a
full facepiece or helmet/hood (APF 50).
If the measured exposure concentration is unknown or at
any value above 100 ppm and up to 2,000 ppm (1,000 times the ECEL): The
required respirator protection is: (i) Any NIOSH Approved[supreg] SAR
or Airline Respirator in a continuous-flow mode equipped with a full
facepiece or certified helmet/hood (APF 1,000)); or (ii) Any NIOSH
Approved[supreg] SAR or Airline Respirator in pressure-demand or other
positive-pressure mode equipped with a full facepiece and an auxiliary
self-contained air supply (APF 1,000)); or (iii) Any NIOSH
Approved[supreg] SCBA in a pressure-demand or other positive-pressure
mode equipped with a full facepiece or certified helmet/hood (APF
1,000+).
Table 2--Respiratory Protection Conditions and Requirements
------------------------------------------------------------------------
Minimum required respirator
Concentration condition protection
------------------------------------------------------------------------
At or below the ECEL and EPA STEL...... No respirator required.
Above ECEL (2 ppm) and less than or Any NIOSH Approved[supreg]
equal to 50 ppm (25 times the ECEL). supplied-air respirator (SAR)
or airline respirator in a
continuous-flow mode equipped
with a loose-fitting facepiece
or helmet/hood (APF 25).
Above 50 ppm and less than or equal to Either (i) any NIOSH
100 ppm (50 times the ECEL). Approved[supreg] Supplied-Air
Respirator (SAR) or airline
respirator in a demand mode
equipped with a full facepiece
(APF 50); or (ii) any NIOSH
Approved[supreg] Self-
Contained Breathing Apparatus
(SCBA) in demand-mode equipped
with a full facepiece or
helmet/hood (APF 50).
Unknown concentration or at any value One of (i) any NIOSH
above 100 ppm and up to 2,000 ppm Approved[supreg] Supplied-Air
(1,000 times the ECEL). Respirator (SAR) or Airline
Respirator in a continuous-
flow mode equipped with a full
facepiece or certified helmet/
hood (APF 1,000); or (ii) any
NIOSH Approved[supreg]
Supplied-Air Respirator (SAR)
or Airline Respirator in
pressure-demand or other
positive-pressure mode
equipped with a full facepiece
and an auxiliary self-
contained air supply (APF
1,000); or (iii) any NIOSH
Approved[supreg] Self-
Contained Breathing Apparatus
(SCBA) in a pressure-demand or
other positive-pressure mode
equipped with a full facepiece
or certified helmet/hood (APF
10,000).
------------------------------------------------------------------------
7. Additional Finalized Requirements
a. Workplace Participation
EPA encourages owners and operators to consult with potentially
exposed persons and on the development and implementation of exposure
control plans and PPE/respirator programs. EPA is finalizing its
requirement that owners and operators provide potentially exposed
persons regular access to the exposure control plans, exposure
monitoring records, PPE program implementation, and respirator program
implementation (such as fit-testing and other requirements) described
in 29 CFR 1910.134(l). To ensure compliance with workplace
participation, EPA is finalizing its requirement that the owner or
operator document the notice to and ability of any potentially exposed
person that may reasonably be affected by methylene chloride inhalation
exposure to readily access the exposure control plans, facility
exposure monitoring records, PPE program implementation, or any other
information relevant to methylene chloride inhalation exposure in the
workplace.
b. Notification of Monitoring Results
EPA is finalizing the requirement that when a potentially exposed
person's exposure to methylene chloride exceeds the ECEL action level
within a regulated area, the owner or operator will be required to
inform each potentially exposed person of the quantity, location,
manner of use, release, and storage of methylene chloride and the
specific operations in the workplace that could result in exposure to
methylene chloride, particularly noting where exposures may be above
the ECEL or EPA STEL. EPA further requires 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 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 ECEL, ECEL
action level, and EPA STEL and what they mean in plain language, the
exposure monitoring results, and any corresponding respiratory
protection required. If the ECEL or STEL is exceeded, the notice would
also be required to include a description of the actions taken by the
owner or operator to reduce inhalation exposures to or below the ECEL
or EPA STEL which states the actions to be taken to reduce exposures.
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).
c. Recordkeeping
For each monitoring event of methylene chloride, EPA is requiring
that the owner or operator record, similar to OSHA under 29 CFR
1910.1052(m), information including but not limited to, dates;
operations involving exposure; sampling and analytical methods; the
number of samples; durations, and results of each sample taken; the
type of respirator and PPE worn (if any); the potentially exposed
persons' names, work shifts, and job classifications; and exposure of
all the potentially exposed persons represented by monitoring,
indicating which potentially exposed persons were actually monitored.
EPA further requires documentation of the following whenever monitoring
for the WCPP is required under TSCA section 6(a):
(i) All measurements that may be necessary to determine the
conditions
[[Page 39281]]
(e.g., work site temperatures, humidity, ventilation rates, monitoring
equipment type and calibration dates) that may affect the monitoring
results;
(ii) All other potentially exposed persons whose exposure was not
measured but whose exposure is intended to be represented by the area
or representative sampling monitoring;
(iii) Use of established analytical methods such as those outlined
in appendix A of the ECEL memo (Ref. 93) with a limit of detection
below the ECEL action level and accuracy of monitoring within 25% for
the ECEL and 35% for the EPA STEL, as discussed in Unit IV.B.4.a., so
that the owner or operator may identify when the implementation of
additional exposure controls is necessary, determine the monitoring
frequency according to the requirements described in this unit, and
properly identify and provide persons exposed to methylene chloride
with the required respiratory equipment and PPE in this unit;
(iv) Compliance with the GLP Standards at 40 CFR part 792 or any
accredited lab including AIHA (e.g., AIHA LAP, LLC Policy Module 2A/B/E
of Revision 17.3), or other analogous industry-recognized program;
(v) Information regarding air monitoring equipment, including:
Type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
For owners and operators to demonstrate compliance with the WCPP
provisions, EPA is requiring that owners and operators must retain
compliance records for five years (although this requirement does not
supplant any longer recordkeeping retention time periods such as those
required under 29 CFR 1910.1020, or other applicable regulations). EPA
is requiring the owner or operator to retain records of:
Exposure control plan;
Regulated areas and authorized personnel;
Facility exposure monitoring records;
Notifications of exposure monitoring results;
PPE and respiratory protection used and program
implementation; and
Information and training required under 29 CFR
1910.1052(l) and appendix A, provided by the owner or operator to each
potentially exposed person prior to or at the time of initial
assignment to a job involving potential exposure to methylene chloride.
EPA emphasizes that all records required to be maintained can be
kept in the most administratively convenient form; electronic record
form or paper form. The owner or operator is required to document
training or re-training of any potentially exposed person as necessary
to ensure that, in the event of monitoring results that indicate
exposure or possible exposures above the ECEL action level or the EPA
STEL, the potentially exposed person has demonstrated understanding of
how to safely use and handle methylene chloride and how to
appropriately use required PPE. In addition, the owner or operator is
required to update the training and requisite documentation when there
is reasonable expectation that exposure may exceed the ECEL action
level due to change in tasks or procedures.
8. Compliance Timeframes
With regard to the compliance timeframe for those occupational
conditions of use which are subject to the WCPP, EPA is not finalizing
the timeframes proposed. Rather, as discussed in Unit III.D.1., based
on consideration of public comments, EPA is finalizing the timeframes
considered in the primary alternative action for the private sector and
is providing Federal agencies and Federal contractors acting for or on
behalf of the Federal Government additional time to comply with each of
the provisions of the WCPP. Specifically, EPA is finalizing its
requirement that owners and operators in the private sector establish
initial exposure monitoring according to the process outlined in this
unit within 360 days after date of publication of the final rule in the
Federal Register, while Federal agencies and Federal contractors acting
for or on behalf of the Federal Government must conduct initial
exposure monitoring within 915 days after the date of publication. EPA
is also finalizing its requirement that each owner or operator in the
private sector ensure that the airborne concentration of methylene
chloride does not exceed the ECEL or EPA STEL for all potentially
exposed persons within 450 days after the date of publication of the
final rule in the Federal Register, while Federal agencies and Federal
contractors acting for or on behalf of the Federal Government must
comply with the ECEL and the EPA STEL within 1,005 days after the date
of publication. If applicable, each owner or operator must provide
respiratory protection sufficient to reduce inhalation exposures to
below the ECEL or EPA STEL to all potentially exposed persons in the
regulated area within three months after receipt of the results of any
exposure monitoring. For the private sector, this will be within 15
months after the date of publication of the final rule in the Federal
Register. For Federal agencies and Federal contractors acting for or on
behalf of the Federal Government, this will be within 33 months after
the date of publication. For any new facilities, or any facility
commencing one or more conditions of use listed in Unit IV.B.1. after
May 5, 2025, the timeframe for the requirement for initial exposure
monitoring is described earlier in Unit IV.B.4.b.; following that, the
requirements and timeframes for periodic monitoring in Unit IV.B.4.c.
would apply and owners and operators must ensure that no person is
exposed to an airborne concentration of methylene chloride that exceeds
the ECEL or EPA STEL within 90 days following the initial exposure
monitoring). EPA is also finalizing the requirement that owners and
operators demarcate a regulated area within three months after receipt
of any exposure monitoring that indicates exposures exceeding the ECEL
or EPA STEL. Owners and operators in the private sector shall proceed
accordingly to implement an exposure control plan, including
institution of feasible exposure controls other than PPE, within 540
days after date of publication of the final rule in the Federal
Register, while Federal agencies and Federal contractors acting for or
on behalf of the Federal Government must implement an exposure control
plan within 1095 days after the date of publication.
C. Prohibition of Manufacture, Processing, Distribution, and Commercial
Use of Methylene Chloride
In general, EPA is finalizing the prohibitions as proposed, with
some modifications, including for compliance timeframes to provide for
reasonable transitions, based on consideration of the public comments,
as described in Unit III. The rule prohibits manufacture, processing,
distribution, and all industrial and commercial use of methylene
chloride and methylene chloride containing products, except for those
uses which will continue under the WCPP, as identified in Unit IV.B.1.
After consideration of public comments, EPA is finalizing timeframes
longer than proposed for prohibition of manufacture, processing,
distribution, and commercial use of methylene chloride broadly, as well
as for particular uses such as commercial use of methylene chloride in
adhesives and sealants in aircraft, space vehicles, and turbine
applications; and commercial use of methylene chloride in paint and
coating removal for the refinishing of wooden pieces of artistic,
cultural, or historic value. The rationale for these changes from the
proposed rule is in Unit III.B. and Unit III.D.2.
[[Page 39282]]
As discussed in Unit IV.A. and in the Response to Comments, the
prohibitions do not apply to any substance that is excluded from the
definition of ``chemical substance'' under TSCA section 3(2)(B)(ii)
through (vi) (Ref. 7).
The final regulation will impose prohibitions in a staggered
timeframe, beginning at the top of the supply chain, as proposed. As
discussed in Unit III.D.2., in response to comments received, EPA is
finalizing longer timeframes than proposed for prohibition of
manufacturing, processing, distributing, or commercial use of methylene
chloride, but finalizing as proposed for distribution to and by
retailers, in order to expeditiously remove exposures to consumers. EPA
is finalizing timeframes for prohibitions according to the following
staggered timeframe:
Within 270 days of publication of the final rule in the
Federal Register for prohibitions on distributing to retailers;
Within 360 days of publication of the final rule in the
Federal Register for prohibitions on distribution by retailers;
Within 360 days of publication of the final rule in the
Federal Register for prohibitions on manufacturing;
Within 450 days of publication of the final rule in the
Federal Register for prohibitions on processors;
Within 630 days of publication of the final rule in the
Federal Register for prohibitions on all distributors other than
retailers; and
Within 720 days of publication of the final rule in the
Federal Register for prohibitions on most industrial and commercial use
after the publication date of the final rule in the Federal Register.
(Timeframes for prohibitions on distribution of methylene chloride
and methylene-chloride containing products to retailers are provided in
Unit IV.D., in relation to consumer use).
Additionally, for two conditions of use, EPA is finalizing
prohibitions that would take effect in five years. Those two conditions
of use are commercial use of methylene chloride in adhesives and
sealants in aircraft, space vehicle, and turbine applications for
structural and safety critical non-structural applications, and for
commercial use of methylene chloride in refinishing wood pieces of
artistic, cultural, or historic value (which also includes interim
requirements for minimum exposure controls). While EPA had proposed
that these prohibitions begin to be implemented within 90 days for
manufacturers, 180 days for processors, 270 days for distributors to
retailers, 360 days for all other distributors and retailers, and 450
days for industrial and commercial uses after the publication date of
the final rule, EPA is modifying the timeframes proposed based on the
information received in public comment.
EPA is delaying compliance with the prohibition for a subset of the
industrial and commercial use of methylene chloride in adhesives and
sealants, namely when that adhesive or sealant is used in aircraft,
space vehicle, or turbine applications for structural and safety
critical non-structural applications. As described in Unit III.B.2.,
this use of methylene chloride includes applications such as use in
bonding critical turbine engine hardware, use as a joining compound in
engine parts, and adhesive to bond capacitors, transformers,
components, military PC boards and subassemblies, and gasket sealants
in aerospace systems. Based on information received in public comments,
EPA is finalizing delayed compliance of five years before prohibition
for industrial or commercial use of methylene chloride for adhesives
and sealants in aircraft, space vehicle, and turbine applications for
structural and safety critical non-structural applications.
Regarding commercial use of methylene chloride for paint and
coating removal for wood furniture, decorative pieces, and
architectural fixtures of artistic, cultural, or historic value, as
discussed in Unit III.B.1., EPA is modifying the compliance dates
proposed for prohibitions and is finalizing a compliance date of five
years before prohibitions only for the narrowly described commercial
use of methylene chloride in this unit: For refinishing wood pieces of
artistic, cultural, or historic value, as discussed in Unit III.B.1.
During the interim period before prohibition, owners or operators
must not only restrict refinishing using methylene chloride only to
wooden furniture, decorative pieces, and architectural fixtures of
artistic, cultural or historic value, but also must meet a minimum
standard of exposure control. That includes: (1) Use of a regulated
area; (2) use of local exhaust ventilation, both bringing air in from
outside of the workspace where methylene chloride is being used and
pulling methylene chloride vapors away from the potentially exposed
person; and (3) use of any NIOSH Approved[supreg] SAR or airline
respirator in a demand mode equipped with a full facepiece (APF 50) or
any NIOSH Approved[supreg] SCBA in demand-mode equipped with a full
facepiece or helmet/hood (APF 50) or the appropriate respirator based
on initial monitoring as outlined in Unit IV.B.4.b. and in the
regulatory text under 40 CFR 751.109(d).
The owner or operator shall document each instance of refinishing
wooden furniture, decorative pieces, and architectural fixtures of
artistic, cultural or historic value. The documentation shall make
record of the date of the refinishing activity, a description of the
piece that was refinished and an explanation of its artistic, cultural,
or historic value, the owner of the refinished piece, and the methylene
chloride product used. EPA generally expects this information to be
part of normal business records.
D. Prohibition of Manufacture, Processing, and Distribution in Commerce
for Consumer Use of Methylene Chloride
The final rule prohibits the manufacture, processing, and
distribution in commerce of methylene chloride and methylene chloride
containing products for all consumer use. EPA is finalizing as proposed
the prohibition on retailers from distributing in commerce methylene
chloride and all methylene chloride-containing products, in order to
prevent products intended for industrial and commercial use under the
WCPP from being purchased by consumers. EPA is finalizing that the
prohibition on distribution in commerce of methylene chloride within
270 days for distributing to retailers, and 360 days for retailers
distributing in commerce after the publication date of the final rule
in the Federal Register.
A retailer is any person or business entity that distributes or
makes available products to consumers, including through e-commerce
internet sales or distribution. If a person or business entity
distributes or makes available any product to at least one consumer,
then it is considered a retailer (40 CFR 751.103). For a distributor
not to be considered a retailer, the distributor must distribute or
make available products solely to commercial or industrial end-users or
businesses. Prohibiting manufacturers (including importers),
processors, and distributors from distributing methylene chloride, or
any products containing methylene chloride, to retailers prevents
retailers from making these products available to consumers, which
addresses that part of the unreasonable risk from methylene chloride
contributed by consumer use. EPA first promulgated this definition,
with this rationale, in the earlier rule to regulate methylene chloride
in consumer paint and coating removers (84 FR 11420, March 27, 2019)
(FRL-
[[Page 39283]]
9989-29) and is finalizing as proposed for this regulation as well.
E. Other Requirements
1. Recordkeeping
For conditions of use that are not otherwise prohibited under this
final rule, EPA is finalizing as proposed the requirement that
manufacturers, processors, and distributors maintain ordinary business
records, such as invoices and bills-of-lading, that demonstrate
compliance with restrictions and other provisions of this final
regulation; and that they maintain such records for a period of five
years from the date the record is generated. This requirement begins at
the effective date of the rule (60 days following publication of the
final rule in the Federal Register). Recordkeeping requirements ensure
that owners or operators can demonstrate compliance with the proposed
regulations if necessary. Note that this requirement expands those
recordkeeping requirements promulgated in 2019 at 40 CFR 751.109
affecting manufacturers, processors, and distributors of methylene
chloride.
2. Downstream Notification
For conditions of use that are not otherwise prohibited under this
final regulation, EPA is finalizing as proposed the requirements that
manufacturers (including importers), processors, and distributors,
excluding retailers, of methylene chloride and methylene chloride-
containing products provide downstream notification of certain
prohibitions through Safety Data Sheets (SDSs) by adding to sections
1(c) and 15 of the SDS the following language:
After February 3, 2025, this chemical substance (as defined in
TSCA section 3(2))/product cannot be distributed in commerce to
retailers. After January 28, 2026, this chemical substance (as
defined in TSCA section 3(2))/product is and can only be distributed
in commerce or processed with a concentration of methylene chloride
equal to or greater than 0.1% by weight for the following purposes:
(1) Processing as a reactant; (2) Processing for incorporation into
a formulation, mixture, or reaction product; (3) Processing for
repackaging; (4) Processing for recycling; (5) Industrial or
commercial use as a laboratory chemical; (6) Industrial or
commercial use as a bonding agent for solvent welding; (7)
Industrial and commercial use as a paint and coating remover from
safety critical, corrosion-sensitive components of aircraft and
spacecraft; (8) Industrial and commercial use as a processing aid;
(9) Industrial and commercial use for plastic and rubber products
manufacturing; (10) Industrial and commercial use as a solvent that
becomes part of a formulation or mixture, where that formulation or
mixture will be used inside a manufacturing process, and the solvent
(methylene chloride) will be reclaimed; (11) Industrial and
commercial use in the refinishing for wooden furniture, decorative
pieces, and architectural fixtures of artistic, cultural or historic
value until May 8, 2029; (12) Industrial and commercial use in
adhesives and sealants in aircraft, space vehicle, and turbine
applications for structural and safety critical non-structural
applications until May 8, 2029; (13) Disposal; and (14) Export.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA's final rule
requires manufacturers revise their SDS within 150 days of publication
and processors and distributors revise their SDS within 210 days of
publication of the final rule.
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on methylene chloride
under TSCA and to provide information to commercial end-users about
allowable uses of methylene chloride. Note that this requirement would
amend and add to the downstream notification requirements promulgated
in 2019 at 40 CFR 751.107 for paint and coating removers for consumer
use and additionally redesignate that section as 40 CFR 751.111. As
they become effective, the new amended requirements will supersede
those notification requirements promulgated in 2019.
F. TSCA Section 6(g) Exemptions
EPA is finalizing as proposed a 10-year exemption for emergency use
of methylene chloride in furtherance of the National Aeronautics and
Space Administration (NASA)'s mission for the following specific
conditions of use: Industrial and commercial use as a solvent for cold
cleaning; Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner; Industrial and commercial use in adhesives, sealants
and caulks; Industrial and commercial use in adhesive and caulk
removers; Industrial and commercial use in metal non-aerosol
degreasers; Industrial and commercial use in non-aerosol degreasers and
cleaners; and Industrial and commercial use as a solvent that becomes
part of a formulation or mixture. The exemption includes additional
requirements, pursuant to TSCA section 6(g)(4), including required
notification and controls for exposure, to the extent feasible: (1)
NASA and its contractors must provide notice to the EPA Assistant
Administrators of both the Office of Enforcement and Compliance
Assurance and the Office of Chemical Safety and Pollution Prevention of
each instance of emergency use within 15 working days and; (2) NASA and
its contractors would have to comply with the WCPP described in Unit
IV.B. to the extent feasible.
Specifically, this regulation requires NASA and its contractors to
notify the EPA Assistant Administrators of both the Office of
Enforcement and Compliance Assurance and the Office of Chemical Safety
and Pollution Prevention within 15 days of the emergency use. The
notification must include a description of the specific use of
methylene chloride in the context of one of the conditions of use for
which this exemption is being finalized, an explanation of why the use
described qualifies as an emergency, and an explanation with regard to
the lack of availability of technically and economically feasible
alternatives.
EPA expects NASA and its contractors have the ability to implement
a WCPP as described in Unit IV.B. for the identified uses in the
context of an emergency, to some extent even if not to the full extent
of WCPP implementation. Therefore, NASA and its contractors must comply
with the WCPP to the extent technically feasible in light of the
particular emergency.
NASA and its contractors would still be subject to the general
recordkeeping requirements discussed in Unit IV.B.7.c.
V. TSCA Section 6(c)(2) Considerations
A. Health Effects of Methylene Chloride and the Magnitude of Human
Exposure to Methylene Chloride
EPA's analysis of the health effects of methylene chloride is in
the 2020 Risk Evaluation for Methylene Chloride (Ref. 1). A summary is
presented here.
The 2020 Risk Evaluation for Methylene Chloride identified six non-
cancer adverse health effects: Effects from acute/short-term exposure,
liver effects, immune system effects, nervous system effects,
reproductive/developmental effects, and irritation/burns (Ref. 1). The
2020 Risk Evaluation for Methylene Chloride also identified cancer
hazards from carcinogenicity as well as genotoxicity, particularly for
liver and lung tumors (Ref. 1).
Among the non-cancer adverse health effects, the 2020 Risk
Evaluation for Methylene Chloride identified neurotoxicity indicative
of central nervous system depression as a primary effect of methylene
chloride in humans following acute inhalation exposures (Ref. 1).
Identified central nervous system depressive symptoms include
drowsiness, confusion, headache,
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dizziness, and neurobehavioral deficits when performing various tasks.
Central nervous system depressant effects can result in loss of
consciousness and respiratory depression, possibly resulting in
irreversible coma, hypoxia, and eventual death (Ref. 1).
Additionally, the 2020 Risk Evaluation for Methylene Chloride
identified the liver as a sensitive target organ for inhalation
exposure (Ref. 1). For human health risks to workers and consumers, EPA
identified cancer and non-cancer human health risks. Risks from acute
exposures include central nervous system risks such as central nervous
system depression and a decrease in peripheral vision, each of which
can lead to workplace accidents and are precursors to more severe
central nervous system effects such as incapacitation, loss of
consciousness, coma, and death. For chronic exposures, EPA identified
risks of non-cancer liver effects as well as liver and lung tumors
(Ref. 1).
The 2020 Risk Evaluation for Methylene Chloride also identified
several irritation hazards from methylene chloride exposure. Following
exposures to methylene chloride vapors, irritation has been observed in
the respiratory tract and eyes. Direct contact with liquid methylene
chloride on the skin has caused chemical burns in workers and
gastrointestinal irritation in individuals who accidentally ingested
methylene chloride (Ref. 1).
Regarding the magnitude of human exposure, one factor EPA considers
for the conditions of use that contribute to the unreasonable risk is
the size of the exposed population, which, for methylene chloride, EPA
estimates is 785,000 workers, 135,000 occupational non-users, and 15
million consumers (Ref. 1).
In addition to these estimates of numbers of workers, occupational
non-users, consumers, and bystanders to consumer use directly exposed
to methylene chloride, EPA recognizes there is exposure to the general
population from air and water pathways for methylene chloride. (While
bystanders are individuals in proximity to a consumer use of methylene
chloride, fenceline communities are a subset of the general population
who may be living in proximity to a facility where methylene chloride
is being used in an occupational setting). EPA separately conducted a
screening approach to assess whether there may be risks to the general
population from these exposure pathways. This analysis is summarized in
full in the proposed rule, which includes information on the SACC peer
review (88 FR 28284, May 3, 2023) (FRL-8155-02-OCSPP). This unit
addresses those areas where some risk was indicated at the fenceline,
and the use will be continuing under the rule.
EPA's analysis was presented to the SACC peer review panel in March
2022, and EPA is including SACC recommendations, as appropriate, in
assessing general population exposures in upcoming risk evaluations.
EPA's fenceline analysis for the water pathway for methylene
chloride, based on methods presented to the SACC, did not find risks
from incidental oral and dermal exposure to surface water, and while
EPA found one facility which indicated acute risk from drinking water,
additional assessment of this location identified that there are no
source drinking water intakes for public drinking water systems in
proximity to the facility estimated to have risk, thereby making risks
to the general population through the drinking water pathway unlikely.
Although the initial analysis presented to SACC and the multi-year
analysis conducted in response to SACC feedback for methylene chloride
indicated exposure and associated risks to select populations within
the general population living or working near particular facilities
from the ambient air pathway, EPA is unable to formally determine with
this screening methodology whether those risks contribute to the
unreasonable risk, because the screening methodology was not developed
for that purpose. However, EPA believes that the prohibitions being
finalized for manufacturing (including importing), processing, and
distribution in commerce for all consumer use and most commercial use
would address the majority of exposures to the general population,
including fenceline communities. Of the 14 facilities which indicated
some risk for methylene chloride, under the final regulation, only six
will continue to use methylene chloride (three facilities for
processing: Incorporation into formulation, mixture, or reaction
product, two facilities for plastic and rubber product manufacturing,
and one facility for paint and coating remover), and thus exposures at
the fenceline at the remainder of those facilities would be addressed.
Of those six facilities, the multi-year analysis indicated
potential risk at 100 meters for only three facilities representing two
conditions of use--two for plastic and rubber product manufacturing and
one for processing: Incorporation into a formulation, mixture, or
reaction process. Anticipated use trends for these three conditions of
use are discussed in this unit.
EPA anticipates processing into a formulation, mixture, or reaction
product to decline because, while processing into a formulation,
mixture, or reaction product will continue under a WCPP, all downstream
distribution and use of formulations, mixtures, or reaction products
will be prohibited except those handful of uses which will continue
under the WCPP, a majority of which require the application of neat
methylene chloride, rather than a formulated product. Additionally, the
facility with identified risk at the fenceline for processing:
Incorporation into formulation, mixture, or reaction product does not
appear to have communities currently located at the fenceline based on
land use analysis (Ref. 101). For use of methylene chloride in plastic
and rubber product manufacturing, EPA does not have reason to believe
the use of methylene chloride will increase, nor that there will be
significant increase in fenceline exposures in this sector, which is
heavily regulated by the CAA (Ref. 102).
For both processing: Incorporation into a formulation, mixture, or
reaction product and plastic and rubber product manufacturing, the
final rule would require exposure controls via implementation of a WCPP
as described in Unit IV.B. While it is plausible that efforts to reduce
exposures in the workplace to levels below the ECEL and EPA STEL could
lead to adoption of engineering controls that ventilate more methylene
chloride outside, EPA determined this outcome is unlikely, particularly
for plastic and rubber product manufacturing. This is because, as
discussed in Unit III.A.2., monitoring data submitted during the
comment period indicates current exposure levels are already very near
or below the ECEL so the addition of engineering controls that could,
in theory, ventilate more methylene chloride outside is not expected to
occur. Additionally, in a scenario where venting methylene chloride out
of the work area and into the outside air, this potential exposure
would be required to be limited as a result of the numerous existing
NESHAPs for methylene chloride for these conditions of use under the
CAA (applicable NESHAPs: 40 CFR part 63, subparts F, G, H, and I; 40
CFR part 63, subpart DD; 40 CFR part 63, subpart YY (79 FR 60898,
October 8 2014); 40 CFR part 63, subpart VVV; and 40 CFR part 63
subpart VVVVVV, and any exceedances would be an enforcement issue.
Thus, prohibition of manufacture, processing, and distribution in
commerce of methylene chloride for all
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consumer use and most industrial and commercial use, and prohibition of
most industrial and commercial use of methylene chloride, is expected
to largely address the risks identified in the screening analysis to
any general population or fenceline communities close to facilities
engaging in methylene chloride use. EPA therefore does not intend to
revisit the air pathway for methylene chloride as part of a
supplemental risk evaluation.
B. Environmental Effects of Methylene Chloride and the Magnitude of
Environmental Exposure to Methylene Chloride
EPA's analysis of the environmental effects of and the magnitude of
exposure of the environment to methylene chloride is in the 2020 Risk
Evaluation for Methylene Chloride (Ref. 1). The unreasonable risk
determination for methylene chloride is based solely on risks to human
health; based on the 2020 Risk Evaluation for Methylene Chloride, EPA
determined that exposures to the environment did not contribute to the
unreasonable risk.
For all conditions of use, exposures via water for acute and
chronic exposures to methylene chloride for amphibians, fish, and
aquatic invertebrates do not contribute to the unreasonable risk. To
characterize aquatic organisms' exposure to methylene chloride, modeled
data were used to represent surface water concentrations near
facilities actively releasing methylene chloride to surface water, and
monitored concentrations were used to represent ambient water
concentrations of methylene chloride. EPA considered the biological
relevance of the species to determine the concentrations of concern for
the location of surface water concentration data to produce risk
quotients, as well as frequency and duration of the exposure. While
some site-specific risk quotients, calculated from modeled release data
from facilities conducting recycling, disposal, and wastewater
treatment plant activities, exceeded risk benchmarks, uncertainties in
the analysis were considered. These uncertainties include limitations
in data, since monitoring data were not available near facilities where
methylene chloride is released, and data incorporated from the Toxics
Release Inventory, which does not include release data for facilities
with fewer than ten employees. As an additional uncertainty, the model
does not consider chemical fate or hydrologic transport properties and
may not consider dilution in static water bodies. Additional analysis
indicated that model outputs, rather than monitoring estimates, may
best represent concentrations found at the point of discharge from the
facilities (Ref. 1).
The toxicity of methylene chloride to sediment-dwelling
invertebrates is similar to its toxicity to aquatic invertebrates.
Methylene chloride is most likely present in the pore waters and not
absorbed to the sediment organic matter because methylene chloride has
low partitioning to organic matter. The concentrations in sediment pore
water are similar to or less than the concentrations in the overlying
water, and concentrations in the deeper part of sediment are lower than
the concentrations in the overlying water. Therefore, the risk
estimates, based on the highest ambient surface water concentration, do
not support an unreasonable risk determination to sediment-dwelling
organisms from acute or chronic exposures. There is uncertainty due to
the lack of ecotoxicity studies specifically for sediment-dwelling
organisms and limited sediment monitoring data (Ref. 1).
Based on its physical-chemical properties, methylene chloride does
not partition to or accumulate in soil. Therefore, the physical
chemical properties of methylene chloride do not support an
unreasonable risk determination to terrestrial organisms.
C. Benefits of Methylene Chloride for Various Uses
As described in the proposed rule, methylene chloride is a solvent
used in a variety of industrial, commercial, and consumer use
applications, including adhesives, pharmaceuticals, metal cleaning,
chemical processing, and feedstock in the production of refrigerant
HFC-32 (82 FR 7467). Specifically, methylene chloride use in commercial
paint and coating removal provides benefits for some users because it
is readily available and works quickly and effectively on nearly all
coatings without damaging most substrates. For a variety of additional
uses (e.g., adhesives, adhesive removers, cold pipe insulation, welding
anti-spatter spray) methylene chloride is relatively inexpensive,
highly effective, evaporates quickly, and is not flammable, making it a
popular and effective solvent for many years. As of 2016, the leading
applications for methylene chloride are as a solvent in the production
of pharmaceuticals and polymers and paint removers, although recent
regulations and voluntary industry actions are expected to decrease the
chemical's use in the paint remover sector (40 CFR part 751, subpart
B). The total aggregate production volume ranged from 100 to 500
million pounds between 2016 and 2019 according to CDR (Ref. 6).
D. Reasonably Ascertainable Economic Consequences of the Final Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
The reasonably ascertainable economic consequences of this final
rule include several components, all of which are described in the
Economic Analysis (Ref. 3). With respect to the anticipated effects of
this final rule on the national economy, EPA considered the number of
businesses and workers that would be affected and the costs and
benefits to those businesses and workers and did not find that there
would be an impact on the national economy (Ref. 3). The economic
impact of a regulation on the national economy becomes measurable only
if the economic impact of the regulation reaches 0.25% to 0.5% of Gross
Domestic Product (GDP) (Ref. 103). Given the current GDP, this is
equivalent to a cost of $40 billion to $80 billion. Therefore, because
EPA has estimated that the non-closure-related cost of the proposed
rule would range from $37.0 million annualized over 20 years at a 3%
discount rate and $39.5 million annualized over 20 years at a 7%
discount rate, EPA has concluded that this rule is highly unlikely to
have any measurable effect on the national economy (Ref. 3). In
response to the updated Circular A-4 published in November 2023, the
incremental, non-closure related costs of this rule at a 2% discount
rate ($36.4 million annualized over 20 years) is provided in appendix D
of the Economic Analysis (Ref. 3). In addition, EPA considered the
employment impacts of this final rule, and found that the direction of
change in employment is uncertain, but EPA expects the short-term and
longer-term employment effects to be small.
Of the small businesses potentially impacted by this final rule,
99% (229,635 firms) are expected to have impacts of less than 1% to
their firm revenues (rounded metric), 1% (1,668 firms) are expected to
have impacts between 1 and 3% to their firm revenues (rounded metric),
and 0.5% (1,148 firms) are expected to have impacts greater than 3% to
their firm revenues (rounded metric). Excluding end-users, total
estimated impacts on small businesses are $9.3 million (annualized
using a 7 percent discount rate). End users with economic and
technologically feasible alternatives
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available do not have economic impacts that are estimated beyond rule
familiarization costs ($1.8 million in total costs, annualized using a
7 percent discount rate).
With respect to this rule's effect on technological innovation, EPA
expects this rule to spur more innovation than it will hinder. A
prohibition or significant restriction on the manufacture, processing,
and distribution in commerce of methylene chloride for uses covered in
this final rule may increase demand for existing, as well as
development of additional, safer chemical substitutes. In specifying
delayed compliance with a restriction, EPA must specify a date as soon
as practicable, and that period may be necessary to develop and
implement alternatives to a restricted chemical. For example, the 5-
year delayed compliance with the prohibition for certain furniture
refinishers allows extra time for the continued development and
implementation of alternative paint and coating removers to be
developed and tested in the marketplace. Outreach with processors
indicated some were working on paint and coating removers to fill the
void from methylene chloride products in the event of a prohibition in
commercial industries (e.g. EPA-HQ-OPPT-2020-0465-0181). This rule is
not likely to have significant effects on the environment because, as
discussed in Unit II.C.3., methylene chloride does not present an
unreasonable risk to the environment, though this rule does present the
potential for small reductions in air emissions and soil contamination
associated with improper disposal of products containing methylene
chloride. The effects of this rule on public health are estimated to be
positive, due to the potential prevention of deaths from acute exposure
and reduced risk of cancer from chronic exposure to methylene chloride,
as well as other reduced risks from other effects which, while tangible
and significant, cannot be monetized, as described in Unit V.D.2.
2. Costs and Benefits of the Regulatory Action and of the One or More
Primary Alternative Regulatory Actions Considered by the Administrator
The costs and benefits that can be monetized for this rulemaking
are described at length in in the Economic Analysis (Ref. 3). The non-
closure-related costs for this final rule are estimated to be $37.0
million annualized over 20 years at a 3% discount rate and $39.5
million annualized over 20 years at a 7% discount rate. The monetized
benefits are estimated to be $24.8 to $25.1 million annualized over 20
years at a 3% discount rate and $19.8 to $20.0 million annualized over
20 years at a 7% discount rate. In response to the updated Circular A-4
published in November 2023, the incremental, non-closure related costs
of this rule at a 2% discount rate ($36.4 million annualized over 20
years) and benefits ($27.1 to $27.5 million annualized over 20 years)
are provided in appendix D of the Economic Analysis (Ref. 3).
Due to unique circumstances in furniture refinishing, and, in
particular, commercial use of methylene chloride in refinishing for
wooden furniture, decorative pieces, and architectural fixtures of
artistic, cultural or historic value (as discussed in detail in Unit
III.B.1.), a prohibition of methylene chloride in this industry may
result in firm closures for the sector as a whole. It is possible to
estimate that profits for the 4,899 furniture refinishing firms that
use methylene chloride are approximately $63 million using the average
estimated revenues per firm for NAICS 811420, Reupholstery and
Furniture Repair ($338,525 is average revenue) and an IRS (2013)
estimate for profit in this sector of 3.8% of sales. Profit is related
to, but not the same as producer surplus. Producer surplus is generally
larger than profit since producer surplus is the difference between
total revenue and marginal cost and profit is the difference between
total revenue and total cost. Total revenue for the 4,899 furniture
refinishing firms that use methylene chloride is estimated to be $1.7
billion. Total revenue provides a measure of overall economic activity
for these firms, but does not directly relate to the potential loss of
producer and consumer surplus (i.e., social cost) from potential
closures or price increases in the furniture refinishing industry (Ref.
3). In addition, due to the uncertainty of the number and type of
closures, EPA is unable to include these potential impacts in the
monetized cost estimates for this action.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions.
Estimated costs for regulatory alternatives can be found in the
Economic Analysis for this final rule (Ref. 3).
This final rule is expected to achieve health benefits for the
American public, some of which can be monetized and others that, while
tangible and significant, cannot be monetized due to lack of dose-
response data, as discussed in Unit I.E. At a discount rate of 2
percent over 20 years the monetized net benefits range from ($9.3M) to
($9.0) million (Ref. 3). EPA believes that the balance of costs and
benefits of this final rule cannot be fairly described without
considering the additional, non-monetized benefits of mitigating the
non-cancer adverse effects. The multitude of adverse effects from
methylene chloride exposure can profoundly impact an individual's
quality of life, as discussed in the proposed rule in Units II.A.
(overview), III.B.2. (description of the unreasonable risk), V.A.
(discussion of the health effects), and in the Risk Evaluation (85 FR
37942). Some of the adverse effects can be immediately experienced and
can result in sudden death; others can have impacts that are
experienced for a shorter portion of life but are nevertheless
significant in nature. The incremental improvements in health outcomes
achieved by given reductions in exposure cannot be quantified for non-
cancer health effects associated with methylene chloride exposure, and
therefore cannot be converted into monetized benefits. The qualitative
discussion throughout this rulemaking and in the Economic Analysis
highlights the importance of these non-cancer effects, which are not
able to be monetized in the way that EPA is able to for cancer and
death. These effects include not only cost of illness but also personal
costs such as emotional and mental stress that are hard to measure
appropriately. Considering only monetized benefits significantly
underestimates the impacts of methylene chloride adverse outcomes and
underestimates the benefits of this final rule.
The 2020 Risk Evaluation for Methylene Chloride identified two non-
cancer health effects in reviewed scientific literature relevant to
children, namely reproductive and developmental hazards (Ref. 1). The
2020 Risk Evaluation for Methylene Chloride summarizes human health
hazards identified in the review of scientific literature, including
studies investigating methylene chloride exposure and reproductive and
developmental effects as well as developmental neurotoxicity. Some
epidemiological studies identified effects that include reduced
fertility, spontaneous abortions, oral cleft defects, heart defects,
and autism spectrum disorder (ASD). For ASD, due to methodological
reasons including confounding by other chemicals and lack of temporal
specificity, the 2020 Risk Evaluation for Methylene Chloride did not
advance this hazard to a dose response calculation. Additionally, EPA
did not carry reproductive/developmental effects forward for dose-
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response, because epidemiological studies lacked controls for co-
exposures and animal studies observed effects mostly at higher
methylene chloride concentrations. EPA also did not identify relevant
mechanistic information, which informed this decision (Ref. 1).
Nonetheless, additional health benefits may be achieved by reducing the
incidence of reproductive effects for workers in commercial facilities
or companies that use methylene chloride for the commercial uses
proposed to be regulated (Ref. 3).
EPA was unable to estimate either the precise reduction in
individual risk of these reproductive and developmental effects from
reducing exposure to methylene chloride or the total number of cases
avoided can be estimated due to a lack of necessary data. Nevertheless,
reproductive hazards such as reduced fertility are important
considerations. These health effects are serious and can have impacts
throughout a lifetime; for example, infertility and fertility treatment
can have deleterious social and psychological consequences such as
mental distress (Ref. 104).
The potential impacts of these effects include monetary impacts
from associated healthcare costs such as fertility treatments, as well
as complications from fertility treatments (e.g., higher multiple birth
rates), mental stress and emotional suffering, which cannot be
quantified or monetized but should not be ignored.
3. Cost Effectiveness of the Regulatory Action and of One or More
Primary Alternative Regulatory Actions Considered by the Administrator
Cost effectiveness is a method of comparing certain actions in
terms of the expense per item of interest or goal. A goal of this
regulatory action is to prevent user deaths resulting from exposure to
methylene chloride. While preventing potential deaths due to methylene
chloride exposure is not the only benefit of this regulatory action, it
was the goal selected to use for the cost effectiveness calculations.
The final rule regulatory option costs $27 million per potential
prevented death while the alternative option costs $151 million per
potential prevented death (using the 3 percent discount rate),
indicating that the final rule option is more cost effective compared
to the alternative option (Ref. 3). The primary difference between the
final and alternative option is that the alternative includes
prohibitions on some uses which fall under WCPP in the final rule, most
notably the use of methylene chloride as a processing aid. EPA received
multiple public comments providing detailed cost information on the
impacts of a prohibition of methylene chloride for this condition of
use. This information was incorporated into the cost estimates for the
alternative option (Ref. 3).
VI. TSCA Section 9 Analysis and Section 14 and 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency after submission of the report. As
discussed in this Unit, the Administrator does not determine that
unreasonable risk from methylene chloride under the conditions of use
may be prevented or reduced to a sufficient extent by an action taken
under a Federal law not administered by EPA. EPA's section 9(a)
analysis can be found in full in Unit VII.A. of the proposed rule, and
responses to comments on that 9(a) analysis can be found in the
Response to Comments, section 8.5.1 (Ref. 7).
TSCA section 9(d) instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. For this rulemaking, EPA has
coordinated with appropriate Federal executive departments and agencies
including but not limited to OSHA, CPSC, and NIOSH to, among other
things, identify their respective authorities, jurisdictions, and
existing laws with regard to the risk evaluation and risk management of
methylene chloride.
As discussed in more detail in the proposed rule, OSHA requires
that employers provide safe and healthful working conditions by setting
and enforcing standards and by providing training, outreach, education,
and assistance. OSHA has established health standards for methylene
chloride covering employers in General Industry, Shipyards, and
Construction (29 CFR 1910.1052(a)). Gaps exist between OSHA's authority
to set workplace standards under the OSH Act and EPA's obligations
under TSCA section 6 to eliminate unreasonable risk presented by
chemical substances under the conditions of use. OSHA lacks direct
jurisdiction over state and local government workers, and does not
cover self-employed workers, military personnel, and uniquely military
equipment, systems, and operations, and workers whose occupational
safety and health hazards are regulated by another Federal agency (for
example, the Mine Safety and Health Administration, the Department of
Energy, or the Coast Guard) (Ref. 105). The U.S. Consumer Product
Safety Commission (CPSC), under authority provided to it by Congress in
the CPSA, protects the public from unreasonable risk of injury or death
associated with consumer products. Under the CPSA, CPSC has the
authority to regulate methylene chloride in consumer products, but not
in other sectors such as automobiles, some industrial and commercial
products, or aircraft, for example.
Therefore, EPA maintains that TSCA is the only vehicle to deliver
broad protections to consumers who may use formulations that contain
methylene chloride and whose use contributes to the unreasonable risk
of injury to health from methylene chloride. An action under TSCA is
also able to address occupational unreasonable risk and would reach
entities that are not subject to OSHA. The timeframe and any exposure
reduction as a result of updating OSHA or CPSC regulations for
methylene chloride cannot be estimated, while TSCA imposes a much more
accelerated two-year statutory timeframe for proposing and finalizing
requirements to address unreasonable risk. Regulating methylene
chloride's unreasonable risk utilizing TSCA authority will also avoid
the situation where a patchwork of regulations amongst several Agencies
using multiple laws and differing legal standards would occur and is
therefore a more efficient and effective means of addressing the
unreasonable risk of methylene chloride. Finally, as discussed in
greater detail in the proposed rule, the 2016 amendments to TSCA
altered both the manner of identifying unreasonable risk and EPA's
authority to address unreasonable risk, such that risk management is
increasingly distinct from provisions of the CPSA, FHSA, or OSH Act.
EPA therefore concludes that TSCA is the only regulatory authority
able to prevent or reduce unreasonable risk of methylene chloride to a
sufficient extent across the range of conditions of use, exposures, and
populations of concern. For this reason, in the Administrator's
discretion, the Administrator has
[[Page 39288]]
analyzed this issue and does not determine that unreasonable risk from
methylene chloride may be prevented or reduced to a sufficient extent
by an action taken under a Federal law not administered by EPA.
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk
``unless the Administrator determines, in the Administrator's
discretion, that it is in the public interest to protect against such
risk'' under TSCA. In making such a public interest finding, TSCA
section 9(b)(2) states ``the Administrator shall consider, based on
information reasonably available to the Administrator, all relevant
aspects of the risk . . . and a comparison of the estimated costs and
efficiencies of the action to be taken under this title and an action
to be taken under such other law to protect against such risk.''
Although several EPA statutes have been used to limit methylene
chloride exposure (Refs. 3,5), regulations under those EPA statutes
largely regulate releases to the environment, rather than occupational
or consumer exposures. While these limits on releases to the
environment are protective in the context of their respective statutory
authorities, regulation under TSCA is also appropriate for occupational
and consumer exposures and in some cases can provide upstream
protections that would prevent the need for release restrictions
required by other EPA statutes (e.g., Resource Conservation and
Recovery Act (RCRA), CAA, CWA). Updating regulations under other EPA
statutes would not be sufficient to address the unreasonable risks from
methylene chloride to workers, occupational non-users, consumers, and
bystanders who are exposed under its conditions of use. EPA's section
9(b) analysis can be found in full in Unit VII.B. of the proposed rule,
and responses to comments on that 9(b) analysis can be found in the
Response to Comments, section 8.5.2 (Ref. 7).
For these reasons, the Administrator does not determine that
unreasonable risk from methylene chloride under its conditions of use,
as evaluated in the 2020 Risk Evaluation for Methylene Chloride (Ref.
1), could be eliminated or reduced to a sufficient extent by actions
taken under other Federal laws administered in whole or in part by EPA.
C. TSCA Section 14 Requirements
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI. Under TSCA
sections 14(a) and 14(b)(4), if EPA promulgates a rule pursuant to TSCA
section 6(a) that establishes a ban or phase-out of a chemical
substance, the protection from disclosure of any CBI regarding that
chemical substance and submitted pursuant to TSCA will be ``presumed to
no longer apply,'' subject to the limitations identified in TSCA
section 14(b)(4)(B)(i) through (iii). Pursuant to TSCA section
14(b)(4)(B)(iii), the presumption against protection from disclosure
will apply only to information about the specific conditions of use
that this rule prohibits or phases out. Per TSCA section
14(b)(4)(B)(i), the presumption against protection will not apply to
information about certain emergency uses that this rule exempts from a
ban or phase-out pursuant to TSCA section 6(g). Manufacturers or
processors seeking to protect such information may submit a request for
nondisclosure as provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E).
Any request for nondisclosure must be submitted within 30 days after
receipt of notice from EPA under TSCA section 14(g)(2)(A) stating EPA
will not protect the information from disclosure. EPA anticipates
providing such notice via the Central Data Exchange (CDX).
D. TSCA Section 26 Considerations
As explained in the proposed rule, EPA fulfilled TSCA section 26(h)
by using scientific information, technical procedures, measures,
methods, protocols, methodologies, and models consistent with the best
available science. Comments received on the proposed rule about whether
EPA adequately assessed reasonably available information under TSCA
section 26 on the risk evaluation, and responses to those comments, can
be found in section 8.5.3 of the Response to Comments document (Ref.
7).
VII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation for Methylene Chloride (MC). EPA Document
#740-R1-8010. June 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0107.
2. EPA. Final Revised Unreasonable Risk Determination for Methylene
Chloride, Section 5. 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0742-0120.
3. EPA. Economic Analysis of the Final Regulation of Methylene
Chloride Under TSCA Section 6(a) (RIN 2070-AK70). April 2024.
4. President Joseph R. Biden. The White House. The President and
First Lady's Cancer Moonshot: Ending Cancer As We Know It. Accessed
February 26, 2024. https://www.whitehouse.gov/cancermoonshot/.
5. EPA. Regulatory Actions Pertaining to Methylene Chloride.
February 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0115.
6. EPA. Access CDR Data: 2016 CDR Data. Last Updated on May 2020.
https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
7. EPA. Methylene Chloride; Methylene Chloride; Regulation Under the
Toxic Substances Control Act (TSCA); Response to Public Comments.
RIN 2070-AK70. April 2024.
8. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register. 86 FR 7009, January 25, 2021.
9. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register. 86 FR 7037, January 25, 2021.
10. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
11. Hoang, Ahn, Fagan, Kathleen, Cannon, Dawn L., et al. Assessment
of Methylene Chloride-Related Fatalities in the United States, 1980-
2018. JAMA Internal Medicine. American Medical Association. Chicago,
Illinois. 181(6): 797-805. April 19, 2021.
12. OSHA. Accident Search Results. Keyword: Methylene Chloride.
Accessed February 28, 2024.
13. EPA. An Alternatives Assessment for Use of Methylene Chloride.
November 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0082.
14. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA
Section 6(a). Office of Pollution Prevention and Toxics. October
2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0094.
15. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA
Section 6(a). Office of Pollution Prevention and
[[Page 39289]]
Toxics. October 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0123.
16. Liz Hitchcock; Safer Chemicals Healthy Families. 11/20
Environmental Justice Consultations for 1-Bromopropane and Methylene
Chloride. November 20, 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0088.
17. California Communities Against Toxics et al. Comment letter re
TSCA environmental justice consultations. November 13, 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0088.
18. Swati Rayasam; Program on Reproductive Health and the
Environment (PRHE). PRHE follow up documents from EJ consultation
meeting. November 30, 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0465-0088.
19. EPA. Initial Regulatory Flexibility Analysis for Methylene
Chloride; Regulation of Methylene Chloride under TSCA Section 6(a)
Proposed Rule; RIN 2070-AK70. November 22, 2022.
20. EPA. Final Report of the Small Business Advocacy Review Panel on
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA)
Section 6(a) Methylene Chloride. RIN 2070-AK70. October 28, 2021.
21. EPA. Final Regulatory Flexibility Analysis (FRFA) for Methylene
Chloride; Regulation of Methylene Chloride under TSCA Section 6(a)
Proposed Rule. RIN 2070-AK70. April 2024.
22. EPA. Methylene Chloride: Risk Evaluation and Risk Management
under TSCA Section 6. SBA Small Business Roundtable. September 11,
2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0471-0010.
23. EPA. Public Webinar on Methylene Chloride; Risk Evaluation and
Risk Management under TSCA Section 6. 2020.
24. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Methylene Chloride under TSCA Section 6(a).
25. EPA. 2021 Policy on Children's Health. October 5, 2021.
26. Chris Banach. VanDeMark Chemical Inc. Comment EPA-HQ-OPPT-2020-
0465-0193. June 30, 2023.
27. Stephanie N Daigle. Celanese Corporation Comment EPA-HQ-OPPT-
2020-0465-0217. June 30, 2023.
28. Leigh Bausinger. Faegre Drinker Biddle & Reath LLP Comment EPA-
HQ-OPPT-2020-0465-0218. June 30, 2023.
29. Karen Ethier. ThermoFisher Comment EPA-HQ-OPPT-2020-0465-0213.
July 6, 2023.
30. Lee French. DuPont de Nemours, Inc. Comment EPA-HQ-OPPT-2020-
0465-0224. June 30, 2023.
31. Danielle Jones. Chemours Company Comment EPA-HQ-OPPT-2020-0465-
0242. July 3, 2023.
32. Wanda Copeland Smith. Halocarbon Comment EPA-HQ-OPPT-2020-0465-
0252. July 3, 2023.
33. EMD Electronics. EMD Electronics Comment EPA-HQ-OPPT-2020-0465-
0269. July 3, 2023.
34. Michael Boucher. LANXESS Corporation Comment EPA-HQ-OPPT-2020-
0465-0278. July 3, 2023.
35. SABIC Innovative Plastics. SABIC Innovative Plastics US LLC
Comment EPA-HQ-OPPT-2020-0465-0367. July 3, 2023.
36. Haakan Jonsson. Covestro LLC Comment EPA-HQ-OPPT-2020-0465-0377.
June 29, 2023.
37. Genevieve Strand. Society of Chemical Manufacturers & Affiliates
(SOCMA) Comment EPA-HQ-OPPT-2020-0465-0250. July 3, 2023.
38. Major L. Clark, III. Small Business Administration Comment EPA-
HQ-OPPT-2020-0465-0235. July 3, 2023.
39. EPA. Economic Analysis of the Proposed Regulation of
Trichloroethylene. October 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0642-0178.
40. Kim Medford. ENTEK Manufacturing Comment EPA-HQ-OPPT-2020-0642-
0230. July 14, 2021.
41. John Reeves. Microporous LLC (``Microporous''), Request for
Section 6(g) Exemption. August 10, 2022.
42. SKIET. Sk ie Technology Co. Ltd. (SKIET) Comment EPA-HQ-OPPT-
2020-0465-0226. June 30, 2023.
43. Ohio EPA. Ohio Environmental Protection Agency Comment EPA-HQ-
OPPT-2020-0465-0261. July 3, 2023.
44. Yonhjik Kim. SK On Co. Ltd. Comment EPA-HQ-OPPT-2020-0465-0223.
July 6, 2023.
45. Chad Schumann. Polypore International, LP Comment EPA-HQ-OPPT-
2020-0465-0251. June 30, 2023.
46. Dong Woo Kim. W-Scope Chungju Plant Co. Ltd (WCP) Comment EPA-
HQ-OPPT-2020-0465-0275. July 4, 2023.
47. Federal Consortium for Advanced Batteries (FCAB). National
Blueprint for Lithium Batteries 2021-2030. June 2021.
48. EPA. Covestro LLC Meeting Memo. August 22, 2023.
49. Remy Nathan. Aerospace Industries Association (AIA) Comment EPA-
HQ-OPPT-2020-0465-0168. June 30, 2023.
50. Andy Barsala. GE Aerospace Comment EPA-HQ-OPPT-2020-0465-0234.
July 3, 2023.
51. Steve Shestag. The Boeing Company Comment EPA-HQ-OPPT-2020-0465-
0253. July 3, 2023.
52. Judah Prero. Chemical Users Coalition (CUC) Comment EPA-HQ-OPPT-
2020-0465-0241. July 3, 2023.
53. Carrie McMichael. Solvay Specialty Polymers USA, LLC Comment
EPA-HQ-OPPT-2020-0465-0215. June 30, 2023.
54. Information Technology Industry. Information Technology Industry
Council (ITI) Comment EPA-HQ-OPPT-2020-0465-0254. July 3, 2023.
55. Paul DeLeo. American Chemistry Council (ACC) Comment EPA-HQ-
OPPT-2020-0465-0281. July 3, 2023.
56. Giorgio Zanchi. 3V Sigma USA Comment EPA-HQ-OPPT-2020-0465-0225.
June 30, 2023.
57. Aaron Rice; EaglePicher Technologies, LLC. Re: TSCA Section 6(g)
Exemption Request for Use of N-methylpyrrolidone and Methylene
Chloride in Production of Specialized Batteries. June 3, 2022.
58. James Lee. Ohio Manufacturers' Association (OMA) Comment EPA-HQ-
OPPT-2020-0465-0185. May 30, 2023.
59. EaglePicher. EaglePicher Technologies, LLC Comment EPA-HQ-OPPT-
2020-0465-0214. June 30, 2023.
60. A. Richard Szembrot. Eastman Kodak Company Comment EPA-HQ-OPPT-
2020-0465-0236. July 3, 2023.
61. Michael G. Anderson. Lockheed Martin Corporation Comment EPA-HQ-
OPPT-2020-0465-0244. July 3, 2023.
62. Master Finishing and Restoration. Master Finishing and
Restoration Inc. Comment EPA-HQ-OPPT-2020-0465-0233. July 6, 2023.
63. Restorations Unlimited. Restorations Unlimited. Accessed 11/13/
2023. https://restorationsunlimited.com/gallery.
64. EPA. Restorations Unlimited Meeting Memo. July 27, 2023.
65. Steve Bennett. Household & Commercial Products Association
(HCPA) Comment EPA-HQ-OPPT-2020-0465-0257. July 3, 2023.
66. Benco Sales. Benco Sales Inc. Comment EPA-HQ-OPPT-2020-0465-
0228. July 6, 2023.
67. EPA. Economic Analysis of the Proposed Regulation of Methylene
Chloride. RIN 2070-AK70. August 2022.
68. EPA. Public Workshop on Use of Methylene Chloride in Furniture
Refinishing in collaboration with the Small Business Administration
Office of Advocacy. September 12, 2017. https://www.regulations.gov/document/EPA-HQ-OPPT-2017-0139-0006.
69. Charles Paint Research. Charles Paint Research Inc. Comment EPA-
HQ-OPPT-2020-0465-0194. June 30, 2023.
70. Halogenated Solvent Industry Alliance. Halogenated Solvent
Industry Alliance, Inc. (HSIA) Comment EPA-HQ-OPPT-2020-0465-0285.
May 3, 2023.
71. OSHA. OSHA 1910.155. Access 10/27/23. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.155.
72. EPA. Master Finishing and Restoration, Inc. Meeting Memo. August
8, 2023.
73. EPA. Benco Sales, Inc. Meeting Memo. August 3, 2023.
74. Michael Kennedy. American Petroleum Institute (API) Comment EPA-
HQ-OPPT-2020-0465-0198. June 29, 2023.
75. LeaAnne Forest. American Chemistry Council Comment EPA-HQ-OPPT-
2020-0465-0268. July 3, 2023.
76. Martin J. Durbin. U.S. Chamber of Commerce Comment EPA-HQ-OPPT-
2020-0465-0279. July 3, 2023.
77. Melanie Barrett. Millipore Sigma Comment EPA-HQ-OPPT-2020-0465-
0212. June 30, 2023.
78. 3M. 3M Company Comment EPA-HQ-OPPT-2020-0465-0222. June 30,
2023.
79. Mike LaFore. Dow Chemical Comment EPA-HQ-OPPT-2020-0465-0245.
July 3, 2023.
80. Jennifer C. Gibson. National Association of Chemical
Distributors (NACD) Comment EPA-HQ-OPPT-2020-0465-0188. June 21,
2023.
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81. OSHA. 29 CFR 1910.1200--Appendix A. Accessed 10/27/2023. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200AppA.
82. Mark Ames. American Industrial Hygiene Association (AIHA)
Comment EPA-HQ-OPPT-2020-0465-0187. June 20, 2023.
83. Catherine Palin. Alliance for Automotive Innovation Comment EPA-
HQ-OPPT-2020-0465-0248. July 3, 2023.
84. EPA. Additional Worker and Consumer Risk Analyses in Support of
the 2023 Proposed Regulation of Methylene Chloride under TSCA
Section 6(a). August 14, 2023.
85. Kenji Saito. American College of Occupational and Environmental
Medicine (ACOEM) Comment EPA-HQ-OPPT-2020-0465-0237. July 3, 2023.
86. James Lee. Hach Company Comment EPA-HQ-OPPT-2020-0465-0200. June
29, 2023.
87. William E. Allmond, IV. The Adhesives and Sealants Council, Inc.
Comment EPA-HQ-OPPT-2020-0465-0229. June 30, 2023.
88. Environmental Defense Fund. Environmental Defense Fund (EDF)
Comment EPA-HQ-OPPT-2020-0465-0270. July 3, 2023.
89. EarthJustice et al. EarthJustice et al. Comment EPA-HQ-OPPT-
2020-0465-0262. July 3, 2023.
90. AFL-CIO. American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO) Comment EPA-HQ-OPPT-2020-0465-0219. June 30,
2023.
91. Jean Warshaw. Jean Warshaw Comment EPA-HQ-OPPT-2020-0465-0266.
July 3, 2023.
92. OSHA. OSHA 1999 Multi-Employer Citation Policy. Accessed 10/27/
2023. https://www.osha.gov/enforcement/directives/cpl-02-00-124.
93. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Methylene Chloride. December 10, 2020.
94. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register. 62 FR 1494, January 10, 1997.
95. OSHA. OSHA Technical Manual (OTM) Section II: Chapter 1.
Personal Sampling for Air Contaminants. Last updated on September
14, 2023. https://www.osha.gov/otm/section-2-health-hazards/chapter-1.
96. OSHA. OSHA Method 1025, Methylene Chloride. January 5, 2024.
97. NIOSH. NIOSH Manual of Analytical Methods (NMAM), Fifth Edition.
Volatile Organic Compounds, C1 to C10, Canister Method: METHOD 3900,
Issue 1. August 30, 2018.
98. NIOSH. Hierarchy of Controls. Accessed October 6, 2022. https://www.cdc.gov/niosh/topics/hierarchy/.
99. OSHA; NIOSH. Hazard Alert: Methylene Chloride Hazards for
Bathtub Refinishers. January 2013. https://www.osha.gov/sites/default/files/publications/methylene_chloride_hazard_alert.pdf.
100. OSHA. 1910.1052 App A--Substance Safety Data Sheet and
Technical Guidelines for Methylene Chloride. Accessed October 6,
2022. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1052AppA.
101. EPA. Methylene Chloride: TRI Release Data Sensitivity Analysis.
September 1, 2022.
102. Texas Commission of Environmental Quality. Covestro LLC Comment
EPA-HQ-OPPT-2020-0465-0377 Attachment 4: NSR (State) Permit. May 24,
2022.
103. OMB. Guidance for Implementing Title II of [UMRA]. March 31,
1995.
104. Cousineau, Tara M., Domar, Alice, D. Psychological Impact of
Infertility. Best Practice & Research Clinical Obstetrics &
Gynaecology. Harvard Medical School. Waltham, Massachusetts. 21(2):
293-308. April 2007.
105. U.S. Department of Labor--Occupational Safety and Health
Administration (OSHA). Letter to James J. Jones from David Michaels,
Ph.D., MPH. EPA-HQ-OPPT-2016-0231-0153. March 31, 2016.
106. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA): Regulation of
Methylene Chloride under TSCA Section 6(a) (RIN 2070-AK70). OMB
Control No. 2070-0229. April 2024.
107. OSHA. Industry Profile for an OSHA Standard Results:
Establishment Size: All Sizes: Standard: 19101052 Methylene
Chloride. Accessed February 22, 2024.
108. OSHA. Accident Report Detail. Accident Summary Nr: 157996.015--
Employee Is Killed By Overexposure to Methylene Chloride. Accessed
February 22, 2024.
109. Ashley, Kevin. Harmonization of NIOSH Sampling and Analytical
Methods with Related International Voluntary Consensus Standards.
Journal of Occupational and Environmental Hygiene. Taylor and Fracis
Group. London, England. 12(7): 107-15. 2015.
110. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Methylene Chloride and 1-
Bromopropane under TSCA Section 6(a). Office of Pollution Prevention
and Toxics.
VIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined under
section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4,
1993), as amended by Executive Order 14094 (88 FR 21879, April 11,
2023). Accordingly, EPA submitted this action to the Office of
Management and Budget (OMB) for Executive Order 12866 review.
Documentation of any changes made in response to Executive Order 12866
review is available in the docket. EPA prepared an analysis of the
potential costs and benefits associated with this action. This analysis
(Ref. 3), is available in the docket and summarized in Unit I.E.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2735.02 and OMB Control No. 2070-0229 (Ref.
106). You can find a copy of the ICR in the docket for this rule, and
it is briefly summarized here. The information collection requirements
are not enforceable until OMB approves them.
There are three primary provisions of the final rule that are
expected to increase burden under the PRA.
The first is downstream notification, which will be carried out by
updates to the relevant SDS and which is required for manufacturers,
processors, and distributors in commerce of methylene chloride, who
will provide notice to companies downstream upon shipment of methylene
chloride about the prohibitions. The information submitted to
downstream companies through the SDS will provide knowledge and
awareness of the restrictions to these companies.
The second primary provision of the rule that is expected to
increase burden under the PRA is WCPP-related information generation,
recordkeeping, and notification requirements (including development of
exposure control plans; exposure level monitoring and related
recordkeeping; development of documentation for a PPE program and
related recordkeeping; development of documentation for a respiratory
protection program and related recordkeeping; development and
notification to potentially exposed persons (employees and others in
the workplace) about how they can access the exposure control plans,
exposure monitoring records, PPE program implementation documentation,
and respirator program documentation; and related recordkeeping).
The third primary provision of the rule that is expected to
increase burden under the PRA is recordkeeping for interim requirements
for commercial use of methylene chloride for refinishing wood pieces of
artistic, historic or cultural significance (including documentation of
details related to the refinishing activity and records demonstrating
compliance with the exposure reduction controls).
[[Page 39291]]
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce, or dispose of methylene chloride or
products containing methylene chloride. See also Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
Estimated number of respondents: 237,969.
Frequency of response: On occasion.
Total estimated burden: 149,090 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $16,563,299 (per year), includes $4,451,405
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the EPA
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and publish a technical amendment to 40 CFR part 9 to display
the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to sections 603 and 609(b) of the RFA, 5 U.S.C. 601 et
seq., EPA prepared an IRFA for the proposed rule and convened a SBAR
Panel to obtain advice and recommendations from SER that potentially
would be subject to the rule's requirements. Summaries of the IRFA and
Panel recommendations are presented in the proposed rule (88 FR 28284,
May 3, 2023) (FRL-8155-02-OCSPP).
As required by section 604 of the RFA, EPA prepared a FRFA for this
action (Ref.21). The FRFA addresses the issues raised by public
comments on the IRFA for the proposed rule. The complete FRFA is
available for review in the docket and is summarized here.
1. Statement of Need and Rule Objectives
Under section 6(a) of TSCA (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation, under the conditions of
use, EPA must by rule apply one or more requirements listed in TSCA
section 6(a) to the extent necessary so that the chemical substance or
mixture no longer presents such risk. Methylene chloride was the
subject of a risk evaluation under TSCA section 6(b)(4)(A) that was
issued in June 2020. In addition, in November 2022, EPA issued a
revised unreasonable risk determination that methylene chloride as a
whole chemical substance presents an unreasonable risk of injury to
health under the conditions of use. As a result, EPA is taking action
to the extent necessary so that methylene chloride no longer presents
such risk.
EPA developed this final rule after considering EPA's unreasonable
risk determination for methylene chloride, information provided in
public comments on the proposed rule, findings from and comments on the
SBAR panel, other required consultations, and additional public
outreach. For more information on the proposed rule, SBAR panel, and
outreach efforts for this action, see the docket for this rulemaking
(Docket ID Number EPA-HQ-OPPT-2020-0465).
To address the identified unreasonable risk, this rule: (1)
Prohibits the manufacture, processing, and distribution in commerce of
methylene chloride for consumer use; (2) prohibits most industrial and
commercial uses of methylene chloride using the alternative timeframes
from the proposed rule; (3) delays prohibition timeframes for two
conditions of use of methylene chloride (including as a paint remover
in furniture refinishing) to allow for reasonable transitions to
alternatives; (4) requires a WCPP to be implemented within the
alternative timeframes from the proposed rule for several occupational
conditions of use, including three conditions of use for which the WCPP
was not proposed; (5) removes the proposed distinction between Federal
and commercial use of methylene chloride for two conditions of use
under the WCPP; (6) allows for a de minimis threshold of methylene
chloride in for products to account for impurities and non-intentional
presence; (7) requires recordkeeping and downstream notification
requirements for several conditions of use of methylene chloride; and
(8) provides certain time-limited exemptions from requirements for uses
of methylene chloride which are critical that have no technically
feasible, safer alternative available.
2. Significant Issues Raised by the Public Comments in Response to the
IRFA and EPA Response
An industry trade organization commented that the proposed rule
``discriminates'' against small businesses by providing them no
opportunity to use methylene chloride under the proposed WCPP. The
commenter also stated that the proposed rule contravenes the RFA by
failing to discuss comments provided by small businesses. The commenter
also faulted EPA for not discussing feedback received from small
businesses regarding substitution costs prior to the proposed rule.
EPA Response: EPA's primary responsibility under TSCA is to address
unreasonable risks presented by the chemical substance under the
conditions of use, irrespective of the size of the business. Entities
of any size under the conditions of use for which EPA is finalizing the
WCPP, phaseouts, or time-limited exemptions may continue to process or
use methylene chloride under the restrictions and requirements of the
rule; EPA is not prohibiting or limiting participation due to firm
size. Regarding the RFA, as required by the RFA, EPA convened a SBAR
Panel, solicited input from SERs, used that feedback to generate Panel
recommendations, incorporated those recommendations into the proposed
rule, and published an IRFA and FRFA. EPA also identified the impacts
of this rulemaking on small businesses (Ref. 19) and sought to identify
flexibilities that could be provided. For the Economic Analysis, to the
extent possible, EPA included specific and detailed substitution costs;
however, most information the Agency received was not detailed enough
to be incorporated.
3. SBA Office of Advocacy Comments and EPA Response
SBA Office of Advocacy provided comments on the proposed rule (EPA-
HQ-OPPT-2020-0465). The comments below reflect a portion of the
comments received by the SBA Office of Advocacy during the comment
period. For the full list of comments and responses, see section 3 of
the FRFA (Ref. 21).
Comment: SBA Office of Advocacy requested that EPA accept
additional data after the close of the public comment period.
EPA Response: The Agency is working to finalize rules consistent
with statutory timeframes under TSCA section 6(c)(1), which are to
propose a risk management rulemaking within one year of a final risk
evaluation for the
[[Page 39292]]
chemical substance, and to finalize the rulemaking within two years of
the final risk evaluation. Should a late submission contain data that
could be used to inform a future rulemaking, EPA may consider such
information at that time.
Comment: SBA Office of Advocacy stated that, while EPA refers to
uncertainty as to capacity for ECEL compliance as justification for
proposed bans of methylene chloride, TSCA does not specify any level of
certainty or compliance capability. TSCA simply requires that the
unreasonable risk be addressed only to the extent necessary. SBA Office
of Advocacy further stated that, by issuing the ECEL, EPA has
identified the threshold at which the unreasonable risk is considered
addressed, so if a user can comply with the ECEL, as proposed by EPA,
there should be no unreasonable risk present. In the commenter's view,
speculating about compliance capability goes beyond the scope of the
statute.
EPA Response: EPA disagrees with the interpretation that TSCA
requires EPA to ignore available information related to the ability of
workplaces to successfully implement the WCPP for methylene chloride.
The fact that there continue to be occupational deaths and nonfatal
incidents related to methylene chloride exposure, as well as ongoing
non-trivial levels of noncompliance with the OSHA Methylene Chloride
Standard (Ref. 11), indicate that compliance with regulatory controls
on workplace exposures to methylene chloride, including the WCPP,
cannot be assumed. Moreover, if EPA were to regulate all workplaces via
implementation of the WCPP, EPA believes that it would present
significant and widespread implementation difficulties across multiple
industry sectors, leading to high non-compliance rates that would
undermine the health-protectiveness of the rule. EPA is aware that
there remain ongoing non-trivial levels of noncompliance with the
existing OSHA Methylene Chloride Standard. For example, between October
2022 through September 2023, OSHA issued 44 citations and conducted 14
inspections on their methylene chloride standard, spanning 11
industries including furniture manufacturing and automotive repair. In
addition, OSHA has documented a fatality from methylene chloride as
recently as July 2023 (Ref. 11, 12, 107, 108). Given this background,
EPA does not believe it is reasonable to assume that entities with
ongoing difficulty implementing the WCPP will cease use of methylene
chloride because they are unable to comply with the WCPP. Rather, EPA
expects that those entities would instead continue attempting (albeit
unsuccessfully) to implement such protections, leaving the unreasonable
risk unmitigated. Accordingly, EPA's rule would fail to ensure that
methylene chloride no longer presents an unreasonable risk to health,
as required by TSCA section 6(a). Conversely, where EPA has information
demonstrating that companies can meet the WCPP reliably, there is a
record basis upon which EPA can determine that the condition of use can
continue under the WCPP without contributing to the unreasonable risk
posed by methylene chloride. EPA notes that all industry sectors had
numerous opportunities to provide the agency with monitoring or other
data to indicate the ability for effective exposure reduction for their
uses, but, in some cases, none were provided.
Comment: SBA Office of Advocacy asserted that EPA's proposal
exceeds the statutory directive because it would prohibit the use of
methylene chloride as a processing aid even for a business that
provided data indicating that worker inhalation exposures were
frequently below the ECEL or even the level of detection. SBA Office of
Advocacy also argued that EPA's consideration in the alternative
regulatory action of allowing the WCPP-controlled use of methylene
chloride as a processing aid and for other uses indicates that such an
option would address unreasonable risks.
EPA Response: In the proposed rule, EPA signaled its willingness to
reconsider the proposed prohibition on the commercial use of methylene
chloride as a processing aid should EPA receive adequate supporting
information during the public comment period. As a result of the
information provided by the business referenced by SBA Office of
Advocacy, and additional information received during the comment
period, the final rule permits the commercial use of methylene chloride
as a processing aid to continue under the WCPP.
Comment: SBA Office of Advocacy stated that the proposed ECEL
Action Level is too low and cannot be measured in real time on-site.
SBA Office of Advocacy stated that the ECEL Action Level should be
adjusted to account for the practical limitations faced by small
businesses and ensure the ECEL Action Level is both feasible and
accurately measurable in real-time.
EPA Response: EPA notes that while real-time monitoring is not
required for rule compliance, EPA understands the practical benefits of
real-time occupational exposure monitoring. EPA notes that in the
response to comments, multiple stakeholders acknowledged the viability
of real-time detection for methylene chloride at 1 ppm. EPA
acknowledges that some portable monitoring devices may not be able to
reliably detect the action level in real-time. In conditions that may
ideally benefit real-time monitoring measurements or expedited results,
stationary monitoring devices such as mass spectrometers, as noted by
another commenter, may be helpful. EPA may not always set the action
level for a given chemical at one half the assigned ECEL value. In some
situations, EPA may adjust the action level in a risk management rule
as part of the WCPP.
4. Estimate of the Number of Small Entities to Which the Final Rule
Applies
This final rule potentially affects small manufacturers (including
importers), processors, distributors, retailers, users of methylene
chloride or of products containing methylene chloride, and entities
engaging in disposal. EPA estimates that the final rule would affect
approximately 237,969 firms using methylene chloride, of which 232,451
small entities (based on SBA definitions published in March 2023) have
estimated impacts. End users with economic and technologically feasible
alternatives available do not have estimated cost impacts beyond rule
familiarization costs except for vapor degreasing and furniture
refinishing. For a full description of the estimated number of small
entities affected by this rule, see the FRFA (Ref. 21).
5. Projected Reporting, Recordkeeping and Other Compliance Requirements
of the Final Rule
a. Compliance Requirements
EPA is prohibiting most conditions of use of methylene chloride. As
described in the final rule, EPA is prohibiting all manufacturing
(including import), processing, and distribution in commerce of
methylene chloride for consumer use. After the publication date of the
final rule in the Federal Register, prohibitions on manufacturing,
processing, and distribution in commerce of methylene chloride for
consumer use will occur in 360 days for manufacturers, 450 days for
processers, 270 days for distributing to retailers, and 360 days for
all other distributors and retailers.
EPA is also prohibiting manufacturing (including import),
processing, distribution in commerce of methylene chloride for
commercial use, and all commercial use of methylene chloride
[[Page 39293]]
other than those conditions of use for which EPA is finalizing a WCPP
or providing a time-limited exemption under TSCA section 6(g). The
prohibitions for these commercial uses would become effective following
prohibitions relevant to these uses in stages of the supply chain
before the industrial and commercial use (e.g., manufacturing and
processing). The restrictions follow a staggered schedule for each
stage of the supply chain. Prohibitions come into effect in 360 days
for manufacturers, 450 days for processors, 270 days for distributing
to retailers, 630 days for all other distributors and retailers, and
720 days for industrial and commercial uses after the publication date
of the final rule.
EPA is finalizing a prohibition compliance date delayed by five
years after the publication date of the final rule for commercial use
of methylene chloride in furniture refinishing for wood pieces of
artistic, cultural, or historic value where workshops can meet a
minimum standard of exposure control. Additionally, EPA is finalizing a
delayed prohibition compliance date of five years for industrial and
commercial use in adhesives and sealants in aircraft, space vehicle,
and turbine applications for structural and safety critical non-
structural applications after the publication date of the final rule.
For other conditions of use that contribute to the unreasonable
risk from methylene chloride, EPA is finalizing a WCPP to address the
unreasonable risk as outlined in Unit IV.
A WCPP encompasses inhalation exposure thresholds, includes
monitoring and recordkeeping requirements to verify that those
thresholds are not exceeded, and other components, such as dermal
protection, to ensure that the chemical substance no longer presents
unreasonable risk. In the case of methylene chloride, meeting the
exposure thresholds finalized by EPA for certain occupational
conditions of use would address unreasonable risk driven by inhalation
exposure from those conditions of use for potentially exposed persons.
b. Classes of Small Entities Subject to the Compliance Requirements
The small entities that would be potentially directly regulated by
this rule are small businesses that manufacture (including import),
process, distribute in commerce, use, or dispose of methylene chloride,
including retailers of methylene chloride for end-consumer uses.
c. Professional Skills Needed To Comply
Entities subject to this rule that manufacture (including import),
process, or distribute methylene chloride in commerce for consumer use
would be required to cease such activity. The entity would be required
to modify their Safety Data Sheet to inform their customers of the
prohibition on manufacture, processing, and distribution of methylene
chloride for consumer use. They would also be required to keep records
of how much methylene chloride they sold, and to whom, and maintain a
copy of the method they use for notifying their customers. None of
these activities require any special skills.
Entities that use methylene chloride in any of the industrial and
commercial conditions of use that are prohibited would be required to
cease those activities. Restriction or prohibition of these uses will
likely require the implementation of an alternative chemical or the
cessation of use of methylene chloride in a process or equipment that
may require persons with specialized skills, such as engineers or other
technical experts. Instead of developing an alternative method
themselves, commercial users of methylene chloride may choose to
contract with another entity to do so.
Entities that are permitted to continue to manufacture, process,
distribute in commerce, use, or dispose of methylene chloride are
required to implement a WCPP and would have to meet the provisions of
the program for continued use of methylene chloride. Adaption to a WCPP
may require persons with specialized skills such as an engineer,
chemist, health and safety professional, or laboratory technicians to
process monitoring samples. Instead of implementing the WCPP
themselves, entities that use methylene chloride may choose to contract
with another entity to do so. Records would have to be maintained for
compliance with a WCPP. While this recording activity itself may not
require a special skill, the airborne concentrations to be measured and
recorded may require persons with specialized skills such as an
industrial hygienist or laboratory technician. Additionally,
potentially exposed persons reasonably likely to be exposed to
methylene chloride by inhalation to concentrations above the ECEL or
EPA STEL are required to be trained for the proper use of respirators.
While this does not necessarily entail a specialized skill, it does
require specialized training for those handling methylene chloride
within regulated areas and includes activity-specific training for
proper PPE use such as gloves. EPA's respirator provision, in alignment
with OSHA under 29 CFR 1910.134(c)(1)(ii), also requires medical
qualification to employ the use of respirators. While this is also not
a specialized skill, it is a specialized pre-qualifier for use of
respirators.
Refinishers of wood pieces of artistic, cultural, or historic value
using methylene chloride may need to exercise use of additional
exposure controls such as engineering, administrative, and PPE/
respirators. Establishing adequate controls for this use may require
knowledgeable persons with specialized skills or equipment such as an
engineer or a health and safety professional. Instead of developing the
required exposure mitigation methods themselves to demonstrate
compliance, commercial users of methylene chloride for this use may
choose to contract with another entity to do so.
6. Steps Taken To Minimize Economic Impact to Small Entities
a. SBAR Panel
As required by section 609(b) of the RFA, as amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA), EPA conducted
outreach to small entities and convened a SBAR Panel on November 4,
2020, to obtain advice and recommendations of representatives of the
small entities that potentially would be subject to the rule's
requirements. The Panel solicited input on all aspects of these
proposed regulations. Thirteen potentially impacted small entities
served as small-entity representatives (SERs) to the Panel,
representing a broad range of small entities from diverse geographic
locations. The Panel Report was signed on October 28, 2021.
Consistent with the RFA/SBREFA requirements, the Panel evaluated
the assembled materials and small-entity comments on issues related to
elements of the regulatory flexibility analysis. It is important to
note that the Panel's findings and discussion were based on the
information available at the time the final report was prepared. For
the full list of Panel recommendations, see section 8.A. of the FRFA
(Ref.21).
EPA detailed the SBAR Panel's request for comment on these specific
topics in the IRFA and proposed rule (88 FR 28284, May 3, 2023) (FRL-
8155-02-OCSPP) and solicited comment from the public. During the
comment period, the public provided comment on some of these areas.
Those comments and others received on the proposed rule and EPA's
responses are in the
[[Page 39294]]
Response to Comments document in the docket (Ref. 7).
b. Alternatives Considered
To identify the regulatory approach that would address the
unreasonable risk from methylene chloride, EPA analyzed alternative
regulatory approaches to identify which would be feasible, reduce
burden to small businesses, and achieve the objective of the statute
(i.e., applying one or more requirements list in TSCA section 6(a) to
the extent necessary so that the chemical substance or mixture no
longer presents an unreasonable risk). As described in more detail in
Unit V. of the proposed rule (88 FR 28284, May 3, 2023) (FRL-8155-02-
OCSPP), and Unit II.D. of the final rule, EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions: the effects of methylene
chloride on health and the environment, the magnitude of exposure to
methylene chloride of human beings and the environment, the benefits of
methylene chloride for various uses, and the reasonably ascertainable
economic consequences of the rule. As part of this analysis, EPA
considered a wide variety of control measures to address the
unreasonable risk from methylene chloride such as weight fractions,
prescriptive controls, and a certification and limited access program.
EPA's consideration of these alternative control measures is described
in detail in the IRFA for the proposed rule, and throughout Unit V.A.4.
of the proposed rule.
Based on consideration of public comments received on the proposed
rule, EPA has made some changes from the proposed rule to the final
rule. These changes include the finalization of additional conditions
of use under the WCPP, rather than prohibition, and changes to
timeframes for compliance for the WCPP and for prohibitions. Additional
changes to the rule based on consideration of public comments are
detailed in Unit III of the final rule and include identification of a
de minimis threshold of methylene chloride in formulations, and
modifications to provisions of the WCPP (including to exposure
monitoring requirements). For additional information and rationale
towards alternative actions, see Unit III.D. of this final rule and
section 8.B. of the FRFA (Ref. 21).
In addition, EPA is preparing a Small Entity Compliance Guide to
help small entities comply with this rule. EPA expects that this guide
will be made available on the EPA website prior to the effective date
of this final rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action will
affect entities that use methylene chloride. It is not expected to
affect State, local, or Tribal governments because the use of use of
methylene chloride by government entities is minimal. This action is
not expected to result in expenditures by State, local, and Tribal
governments, in the aggregate, or by the private sector, of $100
million or more (when adjusted annually for inflation) in any 1 year.
Accordingly, this action is not subject to the requirements of sections
202, 203, or 205 of UMRA.
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation under TSCA section 6(a) may preempt state law. EPA
provides the following federalism summary impact statement. The Agency
consulted with state and local officials early in the process of
developing the proposed action to permit them to have meaningful and
timely input into its development. This included a consultation meeting
on October 22, 2020, and a background presentation on September 9,
2020. EPA invited the following national organizations representing
State and local elected officials to these meetings: Association of
State Drinking Water Administrators, National Association of Clean
Water Agencies, Western States Water Council, National Water Resources
Association, American Water Works Association, Association of
Metropolitan Water Agencies, Association of Clean Water Administrators,
Environmental Council of the States, National Association of Counties,
National League of Cities, County Executives of America, U.S.
Conference of Mayors, and National Association of Attorneys General. A
summary of the meeting with these organizations, including the views
that they expressed, is available in the docket (Ref. 14). As discussed
in Unit VIII.E. and in the proposed rule, during Federalism
consultation meetings EPA provided information on TSCA section 6
regulations and participants discussed preemption as well as the
relationship between TSCA and existing statutes such as the CWA and
Safe Drinking Water Act (SDWA) (Ref. 14). EPA provided an opportunity
for these organizations to provide follow-up comments in writing but
did not receive any such comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Methylene chloride is not manufactured,
processed, or distributed in commerce by Tribes and, therefore, this
rulemaking would not impose substantial direct compliance costs on
Tribal governments. Thus, Executive Order 13175 does not apply to this
action.
Notwithstanding the lack of Tribal implications as specified by
Executive Order 13175, EPA consulted with Tribal officials during the
development of this action, consistent with the EPA Policy on
Consultation and Coordination with Indian Tribes, which EPA applies
more broadly than Executive Order 13175.
The Agency held a Tribal consultation from October 7, 2020, to
January 8, 2021, with meetings on November 12 and 13, 2020. Tribal
officials were given the opportunity to meaningfully interact with EPA
concerning the current status of risk management. During the
consultation, EPA discussed risk management under TSCA section 6(a),
findings from the 2020 Risk Evaluation for Methylene Chloride, types of
information to inform risk management, principles for transparency
during risk management, and types of information EPA sought from Tribal
officials (Ref. 15). EPA briefed Tribal officials on the Agency's risk
management considerations and Tribal officials raised no related issues
or concerns to EPA during or in follow-up to those meetings (Ref. 15).
EPA received no written comments as part of this consultation.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of the health and safety effects of
the planned regulation on children in Federal health and safety
standards and explain why the regulation is preferable to
[[Page 39295]]
potentially effective and reasonably feasible alternatives. This action
is not subject to Executive Order 13045 because EPA does not believe
the environmental health or safety risks addressed by this action
present a disproportionate risk to children as reflected by the
conclusions of the methylene chloride risk evaluation (Ref. 1). EPA did
not find that the adverse health impacts for children and for men and
women of reproductive age was disproportionate in comparison to other
populations. While there is some evidence of an association between
methylene chloride and developmental neurological effects, the
literature contains methodological limitations in human studies and
concentration limitations in animal studies, and thus reproductive/
development effects were not carried forward to dose-response. However,
EPA's Policy on Children's health applies to this action. Information
on how the Policy was applied is available under ``Children's
Environmental Health'' in Unit II.D.2.c.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not been designated by the Administrator of the Office
of Information and Regulatory Affairs as a significant energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to
methylene chloride. Consistent with the Agency's Performance Based
Measurement System (PBMS), EPA has decided not require the use of
specific, prescribed analytic methods. Rather, the Agency will allow
the use of any method that meets the prescribed performance criteria.
The PBMS approach is intended to be more flexible and cost-effective
for the regulated community; it is also intended to encourage
innovation in analytical technology and improved data quality. EPA is
not precluding the use of any method, whether it constitutes a
voluntary consensus standard or not, as long as it meets the
performance criteria specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
methylene chloride at the ECEL, the ECEL action level, and the EPA
STEL. Some examples of methods which meet the criteria are included in
appendix A of the ECEL memo (Ref. 93). EPA recognizes that there may be
voluntary consensus standards that meet the criteria (Ref. 109).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that the human health and environmental conditions
that exist prior to this action do not result in or have the potential
to result in disproportionate and adverse human health or environmental
effects on communities with environmental justice concerns in
accordance with Executive Order 12898 (59 FR 7629, February 16, 1994)
and Executive Order 14096 (88 FR 25251, April 26, 2023). As described
more fully in the Economic Analysis for this rulemaking (Ref. 3), EPA
conducted an analysis to characterize the baseline conditions faced by
communities and workers affected by the regulation to identify the
potential for disproportionate impacts on communities with EJ concerns
using information about the facilities, workforce, and communities
potentially affected by the regulatory options under current
conditions, before the regulation would go into effect. The analysis
drew on publicly available data provided by EPA, U.S. Census Bureau,
and Centers for Disease Control and Prevention (CDC), including data
from TRI, EPA Enforcement and Compliance History Online (ECHO),
National Air Toxics Assessment (NATA), the American Community Survey,
and the Behavioral Risk Factor Surveillance System. The baseline
characterization suggests that workers in affected industries and
regions, as well as residents of nearby communities, are not more
likely to be people of color than the general population in affected
states, although this varied by use assessed.
Based on reasonably available information, EPA believes that there
are not potential EJ concerns in communities surrounding facilities
subject to this regulation (Ref. 3). Therefore, EPA believes that this
action is likely to not result in new disproportionate and adverse
effects on communities with EJ concerns. This regulatory action would
apply requirements to the extent necessary so that methylene chloride
no longer presents an unreasonable risk. While this regulatory action
will address unreasonable risks from methylene chloride under the
conditions of use as required by TSCA section 6(a), EPA is not able to
quantify the distribution of the change in risk for affected
populations due to data limitations that prevented EPA from conducting
a more comprehensive analysis of such a change.
EPA additionally identified and addressed potential EJ concerns by
conducting outreach to advocates of communities that might be subject
to disproportionate exposure to methylene chloride.
On November 16 and 19, 2020, EPA held public meetings as part of
this consultation. (Ref. 110). See also Unit II.D. These meetings were
held pursuant to Executive Order 12898 and Executive Order 14008,
Tackling the Climate Crisis at Home and Abroad (86 FR 7619, February 1,
2021). EPA received three written comments following the EJ meetings,
in addition to oral comments provided during the consultations (Refs.
16, 17, 18). In general, commenters supported strong regulation of
methylene chloride to protect lower-income communities and workers.
Commenters supported strong outreach to affected communities,
encouraged EPA to follow the hierarchy of controls, favored
prohibitions, and noted the uncertainty of use--and in some cases
inadequacy--of PPE.
The information supporting this Executive order review is contained
in Unit II.D., as well as in the Economic Analysis (Refs. 3, 110).
EPA's presentations, a summary of EPA's presentation and public
comments made, and fact sheets for the EJ consultations related to this
rulemaking are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/environmental-justice-consultations-methylene-chloride. These materials are also available in the public docket for
this rulemaking.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action meets the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
[[Page 39296]]
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended to read as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.5 by adding in alphabetical order the definitions
for ``Article'', ``Authorized person'', ``Owner or operator'',
``Potentially exposed person'', ``Product'', ``Regulated area'', and
``Retailer'' to read as follows:
Sec. 751.5 Definitions.
* * * * *
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture;
(2) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use; and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical
substances, mixtures, or articles; except that fluids and particles are
not considered articles regardless of shape or design.
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
* * * * *
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
* * * * *
Potentially exposed person means any person who may be exposed to a
chemical substance or mixture in a workplace as a result of a condition
of use of that chemical substance or mixture.
Product means the chemical substance, a mixture containing the
chemical substance, or any object that contains the chemical substance
or mixture containing the chemical substance that is not an article.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the applicable Existing Chemical Exposure Limit (ECEL) or the EPA Short
Term Exposure Limit (EPA STEL).
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Any distributor
with at least one consumer end user customer is considered a retailer.
A person who distributes in commerce or makes available a chemical
substance or mixture solely to commercial or industrial end users or
solely to commercial or industrial businesses is not considered a
retailer.
0
3. Revise Sec. 751.101 to read as follows:
Sec. 751.101 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of methylene chloride (CASRN 75-09-2) to prevent
unreasonable risks of injury to health.
(b) De minimis threshold. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to products containing methylene chloride at thresholds less than 0.1
percent by weight. This provision does not apply to Sec. 751.105.
0
4. Amend Sec. 751.103 by:
0
a. Revising the definition of ``Distribution in commerce''; and
0
b. Adding in alphabetical order definitions for ``ECEL'', ``ECEL action
level'', and ``EPA STEL''.
The revision and additions read as follows:
Sec. 751.103 Definitions.
* * * * *
Distribution in commerce has the same meaning as in section 3 of
the Act, except that the term does not include retailers for purposes
of Sec. Sec. 751.111 and 751.113.
ECEL is an Existing Chemical Exposure Limit, and means an airborne
concentration calculated as an eight (8)-hour time-weighted average
(TWA).
ECEL action level means a concentration of airborne methylene
chloride of 1 part per million (1 ppm) calculated as an 8-hour time
weighted average (TWA).
EPA STEL is a Short Term Exposure Limit, which is an EPA regulatory
limit on workplace exposure to an airborne concentration of a chemical
substance, based on an exposure of less than eight hours.
* * * * *
0
5. Amend Sec. 751.105 by revising the section heading to read as
follows:
Sec. 751.105 Prohibition of manufacturing (including import),
processing, and distribution in commerce related to consumer paint and
coating removal.
Sec. 751.107 [Redesignated as Sec. 751.111]
0
6. Redesignate Sec. 751.107 as Sec. 751.111.
0
7. Add new Sec. 751.107 to read as follows:
Sec. 751.107 Other prohibitions of manufacturing (including import),
processing, distribution in commerce, and use.
(a) Applicability. (1) This section applies to all manufacturing
(including import), processing, and distribution in commerce of
methylene chloride for consumer use other than for the paint and
coating removal use addressed under Sec. 751.105.
(2) This section applies to:
(i) All manufacturing (including import), processing, and
distribution in commerce of methylene chloride for industrial or
commercial use, other than for the conditions of use addressed under
Sec. 751.109(a); and
(ii) All commercial or industrial use of methylene chloride, other
than the conditions of use addressed under Sec. 751.109(a).
(3) This section does not apply to manufacturing, processing, or
distribution in commerce of methylene chloride solely for export that
meets the conditions described in TSCA section 12(a)(1)(A) and (B).
(b) Prohibitions. (1) After February 3, 2025, all persons are
prohibited from distributing in commerce (including making available)
methylene chloride, including any methylene chloride-containing
products, to retailers for any use.
(2) After May 5, 2025, all retailers are prohibited from
distributing in commerce (including making available) methylene
chloride, including any methylene chloride-containing products, for any
use.
(3) After May 5, 2025, all persons are prohibited from
manufacturing (including import) methylene chloride, for the uses
listed in paragraphs (a)(1) and (2) of this section except for those
uses specified in paragraphs (b)(7) through (9) of this section.
(4) After August 1, 2025, all persons are prohibited from
processing methylene chloride, including any methylene chloride-
containing products, for the uses listed in
[[Page 39297]]
paragraphs (a)(1) and (2) of this section except for those uses
specified in paragraphs (b)(7) through (9) of this section.
(5) After January 28, 2026, all persons are prohibited from
distributing in commerce (including making available) methylene
chloride, including any methylene chloride-containing products, for any
use described in paragraphs (a)(1) and (2) of this section except for
those uses specified in paragraphs (b)(7) through (9) of this section.
(6) After April 28, 2026, all persons are prohibited from
industrial or commercial use of methylene chloride, including any
methylene chloride containing products, for the uses listed in
paragraph (a)(2) of this section except for those uses specified in
paragraphs (b)(7) through (9) of this section.
(7) After May 8, 2034, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of methylene chloride, including any methylene chloride
containing products, for industrial or commercial use in an emergency
by the National Aeronautics and Space Administration or its contractors
as described in Sec. 751.115(b).
(8) After May 8, 2029, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of methylene chloride, including any methylene chloride
containing products, for industrial or commercial use for paint and
coating removal for refinishing of wooden furniture, decorative pieces
and architectural fixtures of artistic, cultural, or historic
significance, with interim requirements as described in Sec. 751.117.
(9) After May 8, 2029, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of methylene chloride, including any methylene chloride-
containing products, for industrial or commercial use for adhesives and
sealants in aircraft, space vehicle, and turbine applications for
structural and safety critical non-structural applications.
Sec. 751.109 [Redesignated as Sec. 751.113]
0
8. Redesignate Sec. 751.109 as Sec. 751.113.
0
9. Add new Sec. 751.109 to read as follows:
Sec. 751.109 Workplace Chemical Protection Program.
(a) Applicability. The provisions of this section apply to the
following conditions of use of methylene chloride, including
manufacturing and processing for export, except to the extent the
conditions of use are prohibited by Sec. Sec. 751.105 and 751.107:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing: as a reactant;
(4) Processing: incorporation into a formulation, mixture, or
reaction product;
(5) Processing: repackaging;
(6) Processing: recycling;
(7) Industrial and commercial use as a laboratory chemical;
(8) Industrial or commercial use for paint and coating removal from
safety-critical, corrosion-sensitive components of aircraft and
spacecraft;
(9) Industrial or commercial use as a bonding agent for solvent
welding;
(10) Industrial and commercial use as a processing aid;
(11) Industrial and commercial use for plastic and rubber products
manufacturing;
(12) Industrial and commercial use as a solvent that becomes part
of a formulation or mixture, where that formulation or mixture will be
used inside a manufacturing process, and the solvent (methylene
chloride) will be reclaimed; and
(13) Disposal.
(b) Relationship to other regulations. For purposes of this
section:
(1) Any provisions applying to ``employee'' in 29 CFR 1910.132,
1910.134, and 1910.1052 also apply equally to potentially exposed
persons; and
(2) Any provisions applying to ``employer'' in 29 CFR 1910.132,
1910.134, and 1910.1052 also apply equally to any owner or operator for
the regulated area.
(c) Exposure limits--(1) ECEL. The owner or operator must ensure
that no person is exposed to an airborne concentration of methylene
chloride in excess of 2 parts of methylene chloride per million parts
of air (2 ppm) as an 8-hour TWA after February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, August 1, 2025 for other owners and operators, or beginning
4 months after introduction of methylene chloride into the workplace if
methylene chloride use commences after May 5, 2025, consistent with
paragraphs (d) through (f) of this section.
(2) EPA STEL. The owner or operator must ensure that no person is
exposed to an airborne concentration of methylene chloride in excess of
16 parts of methylene chloride per million parts of air (16 ppm) as
determined over a sampling period of 15 minutes after February 8, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal Government, August 1, 2025 for other owners and operators,
or beginning 4 months after introduction of methylene chloride into the
workplace if methylene chloride use commences after May 5, 2025,
consistent with paragraphs (d) through (f) of this section.
(3) Regulated areas. The owner or operator must:
(i) Establish and maintain regulated areas in accordance with 29
CFR 1910.1052(e)(2) and (4) through (7) by February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, August 1, 2025 for other owners and operators, or within 3
months after receipt of the results of any monitoring data consistent
with paragraph (d) of this section.
(ii) Establish a regulated area wherever a potentially exposed
person's exposure to airborne concentrations of methylene chloride
exceeds or can reasonably be expected to exceed either the ECEL or EPA
STEL.
(iii) 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 methylene chloride within the regulated
area.
(iv) Restrict access to the regulated area by any potentially
exposed person who lacks proper training, personal protective
equipment, or is otherwise unauthorized to enter.
(d) Exposure monitoring--(1) In general--(i) Characterization of
exposures. Owners or operators must determine each potentially exposed
person's exposure, without regard to respiratory protection, by either:
(A) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(B) Taking personal breathing zone air samples that are
representative of each potentially exposed person's exposure.
(ii) Representative samples. Owners or operators are permitted to
consider personal breathing zone air samples to be representative of
each potentially exposed person's exposure, without regard to
respiratory protection, when they are taken as follows:
(A) ECEL. The owner or operator has taken one or more personal
breathing zone air samples for at least one potentially exposed person
in each job classification in a work area during every work shift, and
the person sampled is expected to have the highest methylene chloride
exposure.
[[Page 39298]]
(B) EPA STEL. The owner or operator has taken one or more personal
breathing zone air samples which indicate the highest likely 15-minute
exposures during such operations for at least one potentially exposed
person in each job classification in the work area during every work
shift, and the person sampled is expected to have the highest methylene
chloride exposure.
(C) Exception. 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.
(iii) Accuracy of monitoring. Owners or operators must ensure that
the methods used to perform exposure monitoring produce results that
are accurate to a confidence level of 95%, and are:
(A) Within plus or minus 25% for airborne concentrations of
methylene chloride above the ECEL or the EPA STEL; or
(B) Within plus or minus 35% for airborne concentrations of
methylene chloride at or above the ECEL action level but at or below
the ECEL.
(iv) Currency of monitoring data. Owners or operators are not
permitted to rely on monitoring data that is more than 5 years old to
demonstrate compliance with initial or periodic monitoring requirements
for either the ECEL or the EPA STEL.
(2) Initial monitoring. By November 9, 2026 for Federal agencies
and Federal contractors acting for or on behalf of the Federal
Government, by May 5, 2025 for other owners and operators, or within 30
days of introduction of methylene chloride into the workplace,
whichever is later, each owner or operator covered by this section must
perform an initial exposure monitoring to determine each potentially
exposed person's exposure, unless:
(i) An owner or operator has objective data generated within the
last 5 years prior to May 8, 2024 that demonstrates to EPA that
methylene chloride cannot be released in the workplace in airborne
concentrations at or above the ECEL action level (1-ppm 8-hour TWA) or
above the EPA STEL (16 ppm 15-minute TWA) and that the data represents
the highest methylene chloride exposures likely to occur under
conditions of use described in paragraph (a) of this section; or
(ii) Where potentially exposed persons are exposed to methylene
chloride for fewer than 30 days per year, and the owner or operator has
measurements by direct-metering devices which give immediate results
and which provide sufficient information regarding exposures to
determine and implement the control measures that are necessary to
reduce exposures to below the ECEL action level and EPA STEL.
(3) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
methylene chloride in accordance with table 1.
Table 1 to Paragraph (d)(3)--Periodic Monitoring Requirements Based on
Initial Exposure Monitoring Results
------------------------------------------------------------------------
Air concentration condition observed
during initial exposure monitoring Periodic monitoring requirement
------------------------------------------------------------------------
If the initial exposure monitoring ECEL and EPA STEL periodic
concentration is below the ECEL action monitoring at least once in
level and at or below the EPA STEL. every 5 years.
If the initial exposure monitoring ECEL periodic required at least
concentration is below the ECEL action once every 5 years, and EPA
level and above the EPA STEL. STEL periodic monitoring
required every 3 months.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months.
action level and at or below the ECEL;
and at or below the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months and EPA STEL periodic
action level and at or below the ECEL; monitoring every 3 months.
and above the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is above the ECEL and 3 months and EPA STEL periodic
below, at, or above the EPA STEL. monitoring every 3 months.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency from
indicate that potential exposure has every 3 months to every 6
decreased from above the ECEL to at or months.
below the ECEL, but at or above the
ECEL action level.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency from
indicate that potential exposure has every 6 months to once every 5
decreased to below the ECEL action years. The second consecutive
level and at or below the EPA STEL. monitoring event will
delineate the new date from
which the next 5-year periodic
exposure monitoring must
occur.
If the owner or operator engages in any The owner or operator may forgo
conditions of use described in the upcoming periodic
paragraph (a) of this section and is monitoring event. However,
required to monitor either the ECEL or documentation of cessation of
EPA STEL in a 3-month interval, but use of methylene chloride must
does not engage in any of those uses be maintained, and initial
for the entirety of the 3-month monitoring is required when
interval. the owner or operator resumes
or starts any of the
conditions of use described in
paragraph (a) of this section.
Owner or operator engages in any The owner or operator may forgo
conditions of use described in the upcoming periodic
paragraph (a) of this section and is monitoring event. However,
required to monitor the ECEL in a 6- documentation of cessation of
month interval, but does not engage in the condition(s) of use must
any of those uses for the entirety of be maintained until periodic
the 6-month interval. monitoring resumes, and
initial monitoring is required
when the owner or operator
resumes or starts any of the
conditions of use described in
paragraph (a) of this section.
------------------------------------------------------------------------
(4) Additional monitoring. The owner or operator must conduct the
exposure monitoring required by paragraph (d)(2) of this section within
30 days after any change that may reasonably be expected to introduce
additional sources of exposure to methylene chloride, or otherwise
result in increased exposure to methylene chloride compared to the most
recent monitoring event. Examples of situations that may require
additional monitoring include changes in
[[Page 39299]]
production, process, control equipment, or work practices, or a leak,
rupture, or other breakdown.
(5) Notification of monitoring results. (i) The owner or operator
must inform potentially exposed persons of monitoring results within 15
working days.
(ii) This notification must include the following:
(A) Exposure monitoring results;
(B) Identification and explanation of the ECEL, ECEL Action Level,
and EPA STEL;
(C) Whether the airborne concentration of methylene chloride
exceeds the ECEL action level, ECEL or the EPA STEL;
(D) If the ECEL or EPA STEL is exceeded, descriptions of actions
taken by the owner or operator to reduce exposure in accordance with
paragraph (e)(1)((i) of this section;
(E) Explanation of any required respiratory protection provided in
accordance with as paragraphs (e)(1)(ii) and (f) of this section;
(F) Quantity of methylene chloride in use at the time of
monitoring;
(G) Location of methylene chloride use at the time of monitoring;
(H) Manner of methylene chloride use at the time of monitoring; and
(I) Identified releases of methylene chloride.
(iii) Notice must be provided in plain language writing, in a
language that the person understands, to each potentially exposed
person or posted in an appropriate and accessible location outside the
regulated area with an English-language version and a non-English
language version representing the language of the largest group of
workers who do not read English.
(6) Observation of monitoring. (i) The owner or operator must
provide affected potentially exposed persons an opportunity to observe
exposure monitoring conducted in accordance with this paragraph (d)
that is representative of the potentially exposed person's exposure.
(ii) The owner or operator must ensure that potentially exposed
persons are provided with personal protective equipment appropriate for
the observation of monitoring.
(e) ECEL control procedures and plan--(1) Methods of compliance.
(i) By May 10, 2027 for Federal agencies and Federal contractors acting
for or on behalf of the Federal Government, or by October 30, 2025 for
other owners and operators, the owner or operator must institute one or
a combination of elimination, substitution, engineering controls, work
practices, or administrative controls to reduce exposure to or below
the ECEL and EPA STEL except to the extent that the owner or operator
can demonstrate that such controls are not feasible.
(ii) If the feasible controls, required by paragraph (e)(1)(i) of
this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL or EPA STEL, then the
owner or operator must use such controls to reduce exposure to the
lowest levels achievable by these controls and must supplement those
controls with the use of respiratory protection that complies with the
requirements of paragraph (f) of this section to reduce exposures to or
below the ECEL or EPA STEL.
(iii) Where an owner or operator cannot demonstrate exposure below
the ECEL, including through the use of all feasible engineering
controls, work practices, or administrative controls as described in
paragraph (e)(1)(i) of this section, and, has not demonstrated that it
has appropriately supplemented with respiratory protection that
complies with the requirements of paragraphs (e)(1)(ii) and (f) of this
section, this will constitute a failure to comply with the ECEL.
(iv) For the Department of Defense and Federal contractors acting
for or on behalf of the Department of Defense, in the event that
ongoing or planned construction is necessary to implement the feasible
controls required by paragraph (e)(1)(i) of this section such that no
one is exposed above the ECEL or EPA STEL, the deadlines in paragraph
(e)(1)(i) of this section are extended to May 7, 2029. Ongoing or
planned construction efforts to address exposures above the ECEL and
EPA STEL must be documented in the exposure control plan required by
paragraph (e)(2) of this section.
(2) Exposure control plan. By May 10, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal Government,
or by October 30, 2025 for other owners and operators, the owner or
operator must develop and implement an exposure control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraph (e)(1)(i) of this section, in the following sequence--
elimination, substitution, engineering controls, and work practices and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement the exposure controls selected, including proper
installation, regular inspections, maintenance, training, or other
actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) A description of activities conducted by the owner or operator
to review and update the exposure control plan to ensure effectiveness
of the exposure controls, identify any necessary updates to the
exposure controls, and confirm that all persons are properly
implementing the exposure controls; and
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to methylene chloride, or otherwise result in increased
exposure to methylene chloride, including procedures for implementing
corrective actions to mitigate exposure to methylene chloride.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls, instituted under paragraph (e) of this section.
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (c) through (e) of this section.
(iii) Availability of exposure control plan. (A) Owners or
operators must make the exposure control plan and associated records,
including exposure monitoring, respiratory protection program
implementation, and dermal protection program implementation records,
available to potentially exposed persons.
(B) Owners or operators must notify potentially exposed persons of
the availability of the plan and associated records within 30 days of
the date that the exposure control plan is completed and at least
annually thereafter. The notification must be provided in accordance
with the requirements of paragraph (d)(5)(iii) of this section.
(C) Upon request by the potentially exposed person, the owner or
operator must provide the specified records at a reasonable time,
place, and manner. If the owner or operator is unable to provide the
requested records within 15
[[Page 39300]]
days, the owner or operator must, within those 15 days, inform the
potentially exposed person requesting the record(s) of the reason for
the delay and the earliest date when the record can be made available.
(3) Respirator requirements. The owner or operator must supply a
respirator, selected in accordance with paragraph (f) of this section,
to each potentially exposed person who enters a regulated area and must
ensure each potentially exposed person uses that respirator whenever
methylene chloride exposures may exceed the ECEL or EPA STEL.
(f) Respiratory protection--(1) Respirator conditions. After
February 8, 2027 for Federal agencies and Federal contractors acting
for or on behalf of the Federal Government, after August 1, 2025 for
other owners and operators, or within 3 months after receipt of the
results of any exposure monitoring as described in paragraph (d) of
this section, owners or operators must provide respiratory protection
to all potentially exposed persons in the regulated area as outlined in
paragraph (c)(3) of this section, and according to the provisions
outlined in 29 CFR 1910.134(a) through (l) (except 29 CFR
1910.134(d)(1)(iii)) and as specified in this paragraph (f) for
potentially exposed persons exposed to methylene chloride in
concentrations above the ECEL or the EPA STEL. For the purpose of this
paragraph (f), the maximum use concentration (MUC) as used in 29 CFR
1910.134 must be calculated by multiplying the assigned protection
factor (APF) specified for a respirator by the ECEL or EPA STEL.
(2) Respirator selection criteria. The type of respiratory
protection that regulated entities must select and provide to
potentially exposed persons in accordance with 29 CFR
1910.1052(g)(3)(i), is directly related to the monitoring results, as
follows:
(i) If the measured exposure concentration is at or below the ECEL
or EPA STEL: no respiratory protection is required.
(ii) If the measured exposure concentration is above 2 ppm and less
than or equal to 50 ppm: the respirator protection required is any
NIOSH Approved[supreg] supplied-air respirator (SAR) or airline
respirator in a continuous-flow mode equipped with a loose-fitting
facepiece or helmet/hood (APF 25).
(iii) If the measured exposure concentration is above 50 ppm and
less than or equal to 100 ppm the respirator protection required is:
(A) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a demand mode equipped with a full facepiece (APF
50); or
(B) Any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in demand-mode equipped with a full facepiece or helmet/hood
(APF 50).
(iv) If the measured exposure concentration is unknown or at any
value above 100 ppm and up to 2,000 ppm the respirator protection
required is:
(A) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a continuous-flow mode equipped with a full
facepiece or certified helmet/hood that has been tested to demonstrate
performance at a level of a protection of APF 1,000 or greater. (APF
1,000); or
(B) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in pressure-demand or other positive-pressure mode
equipped with a full facepiece and an auxiliary self-contained air
supply (APF 1,000); or
(C) Any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in a pressure-demand or other positive-pressure mode equipped
with a full facepiece or certified helmet/hood (APF 10,000).
(3) Minimal respiratory protection. Requirements outlined in
paragraph (e)(2) of this section represent the minimum respiratory
protection requirements, such that any respirator affording a higher
degree of protection than the required respirator may be used.
(g) Dermal protection. (1) After February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, or after August 1, 2025 for other owners and operators,
owners or operators must require the donning of gloves that are
chemically resistant to methylene chloride with activity-specific
training where dermal contact with methylene chloride is possible,
after application of the requirements in paragraph (e) of this section,
in accordance with the NIOSH hierarchy of controls.
(2) Owners or operators must minimize and protect potentially
exposed persons from dermal exposure in accordance with 29 CFR
1910.1052(h) and (i).
(h) Training. Owners or operators must provide training in
accordance with 29 CFR 1910.1052(l)(1) through (6) to potentially
exposed persons prior to or at the time of initial assignment to a job
involving potential exposure to methylene chloride. In addition, if
respiratory protection or PPE must be worn within a regulated area,
owners or operators must provide training in accordance with 29 CFR
1910.132(f) to potentially exposed persons within that regulated area.
0
10. Revise newly redesignated Sec. 751.111 to read as follows:
Sec. 751.111 Downstream notification.
(a) After August 26, 2019, and before October 7, 2024, each person
who manufactures (including imports), and before December 4, 2024
processes or distributes in commerce methylene chloride for any use
must, prior to or concurrent with the shipment, notify companies to
whom methylene chloride is shipped, in writing, of the restrictions
described in Sec. 751.105. Notification must occur by inserting the
following text in section 1(c) and section 15 of the SDS provided with
the methylene chloride or with any methylene chloride-containing
product:
This chemical/product is not and cannot be distributed in
commerce (as defined in TSCA section 3(5)) or processed (as defined
in TSCA section 3(13)) for consumer paint or coating removal.
(b) Beginning on October 7, 2024, each person who manufactures
(including import) methylene chloride for any use must, prior to or
concurrent with the shipment, notify companies to whom methylene
chloride is shipped, in writing, of the restrictions described in this
subpart in accordance with paragraph (d) of this section.
(c) Beginning on December 4, 2024, each person who processes or
distributes in commerce methylene chloride or methylene chloride-
containing products for any use must, prior to or concurrent with the
shipment, notify companies to whom methylene chloride is shipped, in
writing, of the restrictions described in this subpart in accordance
with paragraph (d) of this section.
(d) The notification required under paragraphs (b) and (c) of this
section must occur by inserting the following text in section 1(c) and
section 15 of the SDS provided with the methylene chloride or with any
methylene chloride-containing product:
After February 3, 2025, this chemical substance (as defined in
TSCA section 3(2))/product cannot be distributed in commerce to
retailers. After January 28, 2026, this chemical substance (as
defined in TSCA section 3(2))/product is and can only be distributed
in commerce or processed with a concentration of methylene chloride
equal to or greater than 0.1% by weight for the following purposes:
(1) Processing as a reactant; (2) Processing for incorporation into
a formulation, mixture, or reaction product; (3) Processing for
repackaging; (4) Processing for recycling; (5) Industrial or
commercial use as a laboratory chemical; (6) Industrial or
commercial use as a bonding agent for solvent welding; (7)
Industrial and
[[Page 39301]]
commercial use as a paint and coating remover from safety critical,
corrosion-sensitive components of aircraft and spacecraft; (8)
Industrial and commercial use as a processing aid; (9) Industrial
and commercial use for plastic and rubber products manufacturing;
(10) Industrial and commercial use as a solvent that becomes part of
a formulation or mixture, where that formulation or mixture will be
used inside a manufacturing process, and the solvent (methylene
chloride) will be reclaimed; (11) Industrial and commercial use in
the refinishing for wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural or historic value until
May 8, 2029; (12) Industrial and commercial use in adhesives and
sealants in aircraft, space vehicle, and turbine applications for
structural and safety critical non-structural applications until May
8, 2029; (13) Disposal; and (14) Export.
0
11. Revise newly redesignated Sec. 751.113 to read as follows:
Sec. 751.113 Recordkeeping requirements.
(a) General records. Each person who manufactures (including
imports), processes, or distributes in commerce any methylene chloride
after August 26, 2019, must retain in one location at the headquarters
of the company, or at the facility for which the records were generated
beginning July 8, 2024, documentation showing:
(1) The name, address, contact, and telephone number of companies
to whom methylene chloride was shipped;
(2) A copy of the notification provided under Sec. 751.111; and
(3) The amount of methylene chloride shipped.
(b) Exposure control records. Owners or operators must retain
records of:
(1) The exposure control plan as described in Sec. 751.109(e)(2);
(2) Implementation of the exposure control plan described in Sec.
751.109(e)(2), including:
(i) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness; and
(ii) Confirmation that all persons are properly implementing the
exposure controls.
(3) Personal protective equipment (PPE) and respiratory protection
used by potentially exposed persons and program implementation,
including fit-testing, pursuant to Sec. 751.109(f) and (g);
(4) Information and training provided pursuant to Sec. 751.109(h);
and
(5) Occurrence and duration of any start-up, shutdown, or
malfunction of exposure controls or of facility equipment that causes
air concentrations to be above the ECEL or EPA STEL and subsequent
corrective actions taken during start-up, shutdown, or malfunctions to
mitigate exposures to methylene chloride.
(c) Objective data. Objective data generated during the previous 5
years, when used to forgo the initial exposure monitoring, must
include:
(1) The use of methylene chloride being evaluated;
(2) The source of objective data;
(3) The measurement methods, measurement results, and measurement
analysis of the use of methylene chloride; and
(4) Any other relevant data to the operations, processes, or
person's exposure.
(d) Exposure monitoring records. (1) Owners or operators are
required to retain monitoring records that include, at minimum, the
information described at 29 CFR 1910.1052(m)(2)(ii)(A) through (F). For
the purposes of this paragraph (d)(1), cross-referenced provisions in
29 CFR 1910.1052(m)(2)(ii) applying to an ``employee'' apply equally to
potentially exposed persons and cross-referenced provisions applying to
an ``employer'' also apply equally to owners or operators.
(2) For each monitoring event of methylene chloride required under
this subpart, owners or operators must also document the following:
(i) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(ii) The identity of all other potentially exposed persons whose
exposure was not measured and whose exposure is intended to be
represented by the area or representative sampling monitoring;
(iii) Use of established analytical methods;
(iv) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792 or use of a laboratory accredited by
the AIHA or another industry-recognized program; and
(v) Information regarding air monitoring equipment including: Type,
maintenance, calibrations, performance tests, limits of detection, and
any malfunctions.
(3) Owners or operators must maintain copies of exposure monitoring
notifications provided pursuant to Sec. 751.109(d)(5).
(e) Availability of exposure control plans. Owners or operators
must document the notice to and ability of any potentially exposed
persons to access the exposure control plan and other associated
records in accordance with Sec. 751.109(e)(2)(iii).
(f) Records related to exemptions. To maintain eligibility for an
exemption described in Sec. 751.115, the records maintained by the
owners or operators must demonstrate compliance with the specific
conditions of the exemption.
(g) Records related to the refinishing of wooden furniture,
decorative pieces, and architectural fixtures. (1) Owners and operators
of workplaces engaged in the industrial or commercial use of methylene
chloride for the refinishing of wooden furniture, decorative pieces,
and architectural fixtures of artistic, cultural, or historic value
must document each instance of refinishing such pieces.
(2) The documentation required by paragraph (g)(1) of this section
must include:
(i) The date of the refinishing activity;
(ii) A description of the wooden piece that was refinished and an
explanation of its artistic, cultural, or historic value;
(iii) The name of the owner of the refinished wooden piece;
(iv) The name of the individual(s) that refinished the wooden
piece;
(v) A description of the methylene chloride product used and the
quantity of the product used to perform the refinishing; and
(vi) Records demonstrating compliance with the requirements of
Sec. 751.117.
(h) Minimum record retention period. The records required under
this section must be retained for at least 5 years from the date that
such records were generated.
0
12. Add Sec. 751.115 to read as follows:
Sec. 751.115 Exemptions.
(a) In general. (1) Time-limited exemptions described in this
section are established in accordance with 15 U.S.C. 2605(g)(1).
(2) To be eligible for the exemptions established in this section,
regulated parties must comply with all conditions promulgated in this
section for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Exemption for emergency use by the National Aeronautics and
Space Administration. Under 15 U.S.C. 2605(g)(1)(A), the use of
methylene chloride or methylene chloride-containing products in an
emergency by the National Aeronautics and Space Administration and its
contractors operating within the scope of their contracted work for the
conditions of use identified in paragraph (b)(1) of this section is
exempt from the requirements of Sec. 751.107(b)(3) through (6) until
May 8, 2034.
(1) Applicability. This exemption shall apply to the following
specific conditions of use:
(i) Industrial and commercial use as solvent for cold cleaning;
[[Page 39302]]
(ii) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner;
(iii) Industrial and commercial use in adhesives, sealants, and
caulks;
(iv) Industrial and commercial use in adhesive and caulk removers;
(v) Industrial and commercial use in metal non-aerosol degreasers;
(vi) Industrial and commercial use in non-aerosol degreasers and
cleaners; and
(vii) Industrial and commercial use as solvent that becomes part of
a formulation or mixture.
(2) Emergency use. (i) In general. An emergency is a serious and
sudden situation requiring immediate action, within 15 days or less,
necessary to protect:
(A) Safety of the National Aeronautics and Space Administration's
or their contractors' personnel;
(B) The National Aeronautics and Space Administration's missions;
(C) Human health, safety, or property, including that of adjacent
communities; or
(D) The environment.
(ii) Duration. Each emergency is a separate situation; if use of
methylene chloride exceeds 15 days, then justification must be
documented.
(3) Eligibility. To be eligible for the exemption, the National
Aeronautics and Space Administration and its contractors must:
(i) Select methylene chloride because there are no technically and
economically feasible safer alternatives available during the
emergency.
(ii) Perform the emergency use of methylene chloride at locations
controlled by the National Aeronautics and Space Administration or its
contractors.
(iii) Comply with the following conditions:
(A) Notification. Within 15 working days of the emergency use by
the National Aeronautics and Space Administration or its contractors,
the National Aeronautics and Space Administration and its contractors
must provide notice to the EPA Assistant Administrators of both the
Office of Enforcement and Compliance Assurance and the Office of
Chemical Safety and Pollution Prevention that includes the following:
(1) Identification of the condition of use detailed in paragraph
(b)(1) of this section to which the emergency use applies;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(2)(i) of this section; and
(3) An explanation of why methylene chloride was selected,
including why there were no technically and economically feasible safer
alternatives available in the particular emergency.
(B) Exposure. The owner or operator must comply with and document
such compliance efforts under the Workplace Chemical Protection Program
provisions in Sec. 751.109, to the extent technically feasible in
light of the particular emergency.
(C) Recordkeeping. The owner or operator of the location where the
use takes place must comply with the recordkeeping requirements in
Sec. 751.113.
0
13. Add Sec. 751.117 to read as follows:
Sec. 751.117 Interim requirements for paint and coating removal for
the refinishing of wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural, or historic value.
Beginning July 8, 2024, and notwithstanding the timeframes
identified in Sec. 751.109, all persons using methylene chloride,
including any methylene chloride containing products, for industrial
and commercial use for the refinishing of wooden furniture, decorative
pieces and architectural fixtures of artistic, cultural, or historic
value must:
(a) Establish a regulated area in accordance with Sec.
751.109(c)(3);
(b) Use local exhaust ventilation, both bringing air in from
outside and pulling methylene chloride vapors away from the potentially
exposed person; and
(c) Provide minimum respiratory protection:
(1) Use any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a demand mode equipped with a full facepiece (APF
50) or any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in demand-mode equipped with a full facepiece or helmet/hood
(APF 50); or
(2) Use the appropriate respirator based on initial monitoring as
identified in Sec. 751.109(f)(2).
(d) Comply with the recordkeeping requirements in Sec. 751.113(g).
[FR Doc. 2024-09606 Filed 5-7-24; 8:45 am]
BILLING CODE 6560-50-P