[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 28284-28346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09184]
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Vol. 88
Wednesday,
No. 85
May 3, 2023
Part V
Environmental Protection Agency
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40 CFR Part 751
Methylene Chloride; Regulation Under the Toxic Substances Control Act
(TSCA); Proposed Rule
Federal Register / Vol. 88 , No. 85 / Wednesday, May 3, 2023 /
Proposed Rules
[[Page 28284]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0465; FRL-8155-02-OCSPP]
RIN 2070-AK70
Methylene Chloride; Regulation Under the Toxic Substances Control
Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
address the unreasonable risk of injury to human health presented by
methylene chloride under its conditions of use as documented in EPA's
June 2020 Risk Evaluation for Methylene Chloride and November 2022
revised risk determination for methylene chloride prepared under the
Toxic Substances Control Act (TSCA). 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. Methylene chloride, also known as dichloromethane, is acutely
lethal, a neurotoxicant, a likely human carcinogen, and presents cancer
and non-cancer risks following chronic exposures as well as acute
risks. Central nervous system depressant effects can result in loss of
consciousness and respiratory depression, resulting in irreversible
coma, hypoxia, and eventual death, including 85 documented fatalities
from 1980 to 2018, a majority of which were occupational fatalities
(see Unit II.A.). Nevertheless, methylene chloride is still a widely
used solvent in a variety of consumer and commercial applications
including adhesives and sealants, automotive products, and paint and
coating removers. To address the identified unreasonable risk, EPA is
proposing to: prohibit the manufacture, processing, and distribution in
commerce of methylene chloride for consumer use; prohibit most
industrial and commercial uses of methylene chloride; require a
workplace chemical protection program (WCPP), which would include a
requirement to meet inhalation exposure concentration limits and
exposure monitoring for certain continued conditions of use of
methylene chloride; require recordkeeping and downstream notification
requirements for several conditions of use of methylene chloride; and
provide certain time-limited exemptions from requirements for uses of
methylene chloride that would otherwise significantly disrupt national
security and critical infrastructure.
DATES: Comments must be received on or before July 3, 2023. Under the
Paperwork Reduction Act, comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before June 2, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0465, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Ingrid Feustel, Existing
Chemicals Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number 202-564-3199; 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 the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of methylene chloride or products
containing 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);
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);
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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);
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 certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 Code
of Federal Regulations (CFR) 12.118 through 12.127; see also 19 CFR
127.28. Those persons must certify that the shipment of the chemical
substance complies with all applicable rules and orders under TSCA. The
EPA policy in support of import certification appears at 40 CFR part
707, subpart B. In addition, any persons who export or intend to export
a chemical substance that is the subject of this proposed rule are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S.
Environmental Protection Agency, hereinafter EPA or ``the Agency,''
determines through a TSCA section 6(b) risk evaluation that a chemical
substance presents an unreasonable risk of injury to health or the
environment, EPA must by rule apply one or more requirements listed in
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 drive EPA's determination
that methylene chloride presents an unreasonable risk is included in
Unit III.B.2. Accordingly, to address the unreasonable risk, EPA is
proposing, 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.A.3.;
(ii) Prohibit most industrial and commercial use of methylene
chloride, as outlined in Unit IV.A.2.;
(iii) Require 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), as outlined in Unit IV.A.1.;
(iv) Require recordkeeping and downstream notification requirements
for manufacturing, processing, and distribution in commerce of
methylene chloride, as outlined in Unit IV.A.4.;
(v) Provide 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, as outlined in Unit IV.A.5.,
with conditions for this exemption to include compliance with the WCPP
described in Unit IV.A.1.; and
(vi) Provide a 10-year time-limited exemption under TSCA section
6(g) for emergency use of methylene chloride in furtherance of 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, as outlined in
Unit IV.A.5., with conditions for this exemption to include compliance
with the WCPP described in Unit IV.A.1.
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)) are subject to this proposal. Condition of
use is defined in TSCA 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.
EPA is requesting public comment on all aspects of this proposal.
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 (2020 Risk Evaluation
for Methylene Chloride) (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. As a result, EPA is proposing to take action to the
extent necessary so that methylene chloride no longer presents such
risk. The unreasonable risk is described in Unit III.B.1. and the
conditions of use that drive the unreasonable risk for methylene
chloride are described in Unit III.B.2.
EPA emphasizes that some of the adverse effects from methylene
chloride exposure can be immediately experienced and only for a short
duration; others, however, can result in sudden death. Other effects
may result in long-term impacts and should likewise be considered
significant. Methylene chloride's hazards are well established.
Fatalities from acute methylene chloride exposures have
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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 proposed rule would 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 and the
revised unreasonable risk determination for methylene chloride in
November 2022.
EPA is not proposing a complete ban on methylene chloride. The
agency recognizes that continued use of methylene chloride in one of
the TSCA conditions of use may complement the agency's efforts to
address climate-damaging hydrofluorocarbons (HFCs) under the American
Innovation and Manufacturing Act of 2020 (AIM Act), thereby supporting
human health and environmental protection under these programs, and
that, for these HFC-related, reactant processing uses, workplace
controls to address unreasonable risk can be implemented. Therefore,
while addressing the unreasonable risk, this rule proposes to allow
methylene chloride's continued use in tandem with additional worker
protections for the production of HFC-32, one of the regulated
substances that are subject to a phasedown under the AIM Act. While
HFC-32 is one of the regulated substances subject to the phasedown in
production and consumption by 85% over the next 15 years, HFC-32 is
likely to be used to facilitate the transition from certain other HFCs
and HFC blends with higher global warming potentials in certain
applications. EPA expects that, by allowing for the continued use of
methylene chloride in the production of HFC-32, this approach would
complement EPA's work under the AIM Act. For many of the conditions of
use for which EPA is proposing workplace controls under a WCPP, data
was submitted during the risk evaluation and Small Business Advocacy
Review (SBAR process that indicates some facilities may already be in
compliance with the proposed methylene chloride Existing Chemical
Exposure Limit (ECEL). Additionally, the requirements in this proposal
would prohibit uses that account for approximately one third of the
total annual production volume of methylene chloride generated (TSCA
and non-TSCA uses), leaving a sufficient supply in circulation to
provide a source for these critical or essential uses for which EPA is
proposing to allow continued use (Unit IV.A.), either under a WCPP or
through a TSCA section 6(g) exemption (Ref. 3).
E. What are the estimated incremental impacts of this Action?
EPA has prepared an Economic Analysis of the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 3). As described in more detail in the Economic
Analysis (Ref. 3) and in Units VI.D. and X.D., EPA's analysis of the
incremental, non-closure-related costs of this proposed rule is
estimated to be $13.2 million annualized over 20 years at a 3% discount
rate and $14.5 million annualized over 20 years at a 7% discount rate.
These costs take compliance with implementation of a WCPP for certain
conditions of use into consideration, which would include an 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 addition
to the monetized costs discussed previously there are unknown economic
impacts of potential firm closures in the furniture refinishing
industry as discussed in the Economic Analysis. Potential average lost
profits range from $14,000 (one firm closing) to $67 million under the
extreme and unlikely assumption of a complete sector shutdown (Ref. 3).
EPA had also received comments following SBAR meetings where submitted
exposure measurements indicated an ability to achieve ECEL levels,
suggesting that a WCPP for certain uses is achievable; this is further
discussed in Unit V.A.1. Unquantified costs exist, including
determining the best substitute for the firm's specific needs and how a
different product may impact a firm's existing workflow (e.g., does a
different adhesive take longer to dry) and how a firm may work through
the hierarchy of controls to comply with a WCPP. Although some costs
cannot be quantified, they are not necessarily less important than the
quantified costs. The most notable unquantified cost is change in labor
and wait times within applications for which methylene chloride use is
more efficient than substitute methods or alternative chemicals for
achieving desired results. Additionally, in the unique case of
furniture refinishing (within the commercial paint and coating removal
condition of use), alternatives to products containing methylene
chloride may not be economically viable and may cause damage to the
substrate, and thus the prohibition of this use could impact the sector
significantly. After publication of the proposed rule for methylene
chloride in paint and coating removal (82 FR 7464, January 19, 2017)
(FRL-9958-57), EPA, in collaboration with the Small Business
Administration's Office of Advocacy, conducted a workshop on furniture
refinishing in Boston, Massachusetts, on September 12, 2017 (82 FR
41256, August 30, 2017) (FRL-9966-83) to address information gaps for
the furniture refinishing sector identified in that proposed rule. The
workshop was well attended by over 100 furniture refinishing experts,
industry professionals, nongovernmental organizations, academic
experts, and State and Federal Government partners (Ref. 4). The
informative discussion among the participants and invited speakers
touched on the commercial and consumer use of methylene chloride in
furniture refinishing, the potential effects that regulation may have
on businesses, alternatives to methylene chloride, health risks
associated with methylene chloride, and labeling of consumer and
commercial products (speaker presentations, transcript notes, and
public comments are available in the docket EPA-HQ-OPPT-2017-0139).
EPA estimates that as many as 5,000 furniture refinishers still use
methylene chloride, a majority of which are small businesses. While the
amount of methylene chloride paint removers used per firm for furniture
refinishing can vary greatly, industry stakeholder information
indicates one 55-gallon drum every two months (Ref. 4). This would
result in an estimated 2.3 million gallons of formulated paint remover
used annually. The amount of methylene chloride included in this
estimate would depend on the percent in formulation used by the
furniture refinishing firms. The impact of a prohibition of methylene
chloride for furniture refinishing could result in the closure of an
unknown number of the 5,000 potentially affected furniture refinishing
firms using methylene chloride in the baseline.
Based on the estimated revenues per firm presented in Table 3-1 of
the Economic Analysis and the 5,000 estimated number of furniture
refinishing firms using methylene chloride (see Table 6-12 in the
Economic Analysis), the total revenue for furniture refinishing firms
using methylene chloride is approximately $1.8 billion. According to
IRS (2013) data, profit in this sector is about 3.8% of sales.
Therefore, closure of affected furniture refinishing firms using
methylene chloride following this
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rulemaking has an upper bound for economic impacts of $1.8 billion in
total revenue, and $67 million in terms of the total profit, under the
assumption that all affected firms fully close. A detailed discussion
of potential economic impacts as a result of varying percentages of
furniture refinishing firms closing is provided in the Economic
Analysis in section 7.11 (Ref. 3).
EPA identified many alternative products for paint and coating
removers, though many may require longer periods of time, replacement
of equipment, or rework of processes in order to work for furniture
refinishing uses. These may not be appropriate alternatives as they
could damage the wood substrate. Mechanical or thermal methods (i.e.,
sanding, media blasting, and heat guns) are also potential alternatives
for this sector, though they likewise they require different processes,
and often require more time (Refs. 3, 4, 5, 6). For furniture
refinishing, as with other commercial uses, the health benefits that
would result from prohibiting this use of methylene chloride, including
deaths avoided, are further discussed in the Economic Analysis (Ref.
3).
The actions proposed in this rule are expected to achieve health
benefits for the American public, some of which can be monetized and
others that, while tangible and significant, cannot be monetized.
Although some benefits cannot be quantified, they are not necessarily
less important than the quantified benefits. The monetized benefits of
this rule are approximately $17.7 million to $18.5 million annualized
over 20 years at a 3% discount rate and $13.4 million to $13.9 million
annualized over 20 years at a 7% discount rate. The monetized benefits
only include potential reductions in risk of liver cancer, lung cancer,
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
Methylene chloride is acutely lethal, a neurotoxicant, and a likely
human carcinogen. This proposed 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 and
unreasonable risk determination, as described in Unit III.B.2.
Methylene chloride is a colorless liquid and a volatile chemical with a
sweet odor resembling chloroform. It is 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 III.B.1., 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. 7), these regulations include
EPA's 2019 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 aggregate production volume of methylene chloride ranged
from 100 million to 500 million pounds between 2016 and 2019 according
to Chemical Data Reporting (CDR) (Ref. 8). 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 hydrofluorocarbons (HFCs) (Ref. 1). This condition of
use is described in Unit III.B.2., with a description of proposed
requirements to address unreasonable risk in Unit III.B.3, and V.1. An
estimated 35% of the annual production volume of methylene chloride is
for pharmaceutical uses, which are not subject to TSCA and would 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 other Federal, State, and
international regulations, is in the docket (Refs. 1, 7).
C. Consideration of Occupational Safety and Health Administration
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA
Risk Management Actions
TSCA requires EPA to evaluate whether 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 by the Administrator, under the conditions of
use. Conditions of use are the circumstances, as determined by the
Administrator, under which a chemical is intended, known, or reasonably
foreseen to be manufactured, processed, distributed in commerce, used,
or disposed of. If EPA determines through risk evaluation that a
chemical substance presents an unreasonable risk, TSCA section 6
requires EPA to issue regulations applying one or more control
requirements to the extent necessary so that the chemical substance no
longer presents such risk. Although EPA must consider, and in some
cases factor-in, to the extent practicable, non-risk factors as part of
TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must
nonetheless still ensure that the selected regulatory requirements
apply ``to the extent necessary so that the chemical substance or
mixture no longer presents [unreasonable] risk.'' 15 U.S.C. 2605(a).
This risk-based requirement is distinguishable from approaches mandated
by other laws, including the Occupational Safety and Health Act (OSH
Act), which includes both significant risk and feasibility (technical
and economic) assessments in its rulemaking.
Congress intended for EPA to consider occupational risks from
chemicals it evaluates under TSCA, among other potential exposures, as
relevant and appropriate. As noted previously, section 6(b) of TSCA
requires EPA to evaluate risks to potentially exposed or susceptible
subpopulations identified as relevant by the Administrator. TSCA
section 3(12)
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defines the term ``potentially exposed or susceptible subpopulation''
as ``a group of individuals within the general population identified by
the Administrator who, due to either greater susceptibility or greater
exposure, may be at greater risk than the general population of adverse
health effects from exposure to a chemical substance or mixture, such
as infants, children, pregnant women, workers, or the elderly.''
The OSH Act similarly requires OSHA to evaluate risk specific to
workers prior to promulgating new or revised standards and requires
OSHA standards to substantially reduce significant risk to the extent
feasible, even if workers are exposed over a full working lifetime. See
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
Thus, the standards for chemical hazards that OSHA promulgates
under the OSH Act share a broadly similar purpose with the standards
that EPA promulgates under TSCA section 6(a). The control measures OSHA
and EPA require to satisfy the objectives of their respective statutes
may also, in many circumstances, overlap or coincide. However, as this
section outlines, there are important differences between EPA's and
OSHA's regulatory approaches and jurisdiction, and EPA considers these
differences when deciding whether and how to account for OSHA
requirements (such as those described in Unit II.B.2.) when evaluating
and addressing potential unreasonable risk to workers so that
compliance requirements are clearly explained to the regulated
community.
1. OSHA Requirements
OSHA's mission is to ensure that employees work in safe and
healthful conditions. The OSH Act establishes requirements that each
employer comply with the General Duty Clause of the Act (29 U.S.C.
654(a)), as well as with occupational safety and health standards
issued under the Act.
a. General Duty Clause of the OSH Act
The General Duty Clause of the OSH Act requires employers to keep
their workplaces free from recognized hazards that are causing or are
likely to cause death or serious physical harm to employees. The
General Duty Clause is cast in general terms, and does not establish
specific requirements like exposure limits, personal protective
equipment (PPE)), or other specific protective measures that EPA could
potentially consider when developing its risk evaluations or risk
management requirements. OSHA, under limited circumstances, has cited
the General Duty Clause for regulating exposure to chemicals. To prove
a violation of the General Duty Clause, OSHA must prove employer or
industry recognition of the hazard, that the hazard was causing or
likely to cause death or serious physical harm, and a feasible method
to eliminate or materially reduce the hazard was available. In rare
situations, OSHA has cited employers for violation of the General Duty
Clause where exposures were below a chemical-specific permissible
exposure limit (PEL). In such situations, OSHA must demonstrate that
the employer had actual knowledge that the PEL was inadequate to
protect its employees from death or serious physical harm. Because of
the heavy evidentiary burden on OSHA to establish violations of the
General Duty Clause, it is not frequently used to cite employers for
employee exposure to chemical hazards.
b. OSHA Standards
OSHA standards are issued pursuant to the OSH Act and are found in
title 29 of the CFR. There are separate standards for general industry,
construction, maritime and agriculture sectors, general standards
applicable to a number of sectors (e.g., OSHA's Respiratory Protection
standard), and a methylene chloride standard. OSHA has numerous
standards that apply to employers who operate chemical manufacturing
and processing facilities, as well as to downstream employers whose
employees may be occupationally exposed to hazardous chemicals.
OSHA sets legally enforceable limits on the airborne concentrations
of hazardous chemicals, referred to as PELs, established for employers
to protect their workers against the health effects of exposure to
hazardous substances (29 CFR parts 1910, Subpart Z; 1915, Subpart Z;
1926, Subparts D and Z). Under section 6(a) of the OSH Act, OSHA was
permitted an initial 2-year window after the passage of the Act to
adopt ``any national consensus standard and any established Federal
standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971 to
establish PELs that were adopted from Federal health standards
originally set by the Department of Labor through the Walsh-Healy Act,
in which approximately 400 occupational exposure limits were selected
based on the American Conference of Governmental Industrial Hygienists
(ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about
25 exposure limits recommended by the American Standards Association
(now called the American National Standards Institute) (ANSI) were
adopted as PELs.
Following the 2-year window provided under section 6(a) of the OSH
Act for adoption of national consensus and existing Federal standards,
OSHA has issued health standards following the requirements in section
6(b) of the Act. OSHA has established approximately 30 PELs under
section 6(b)(5) as part of comprehensive substance-specific standards
that include additional requirements for protective measures such as
use of PPE, establishment of regulated areas, exposure assessment,
hygiene facilities, medical surveillance, and training. These ancillary
provisions in substance-specific OSHA standards further mitigate
residual risk that could be present due to exposure at the PEL.
Though many OSHA PELs have not been updated since they were
established in 1971, the methylene chloride PEL was last updated as
part of the OSHA methylene chloride standard in 1997. In many
instances, scientific evidence has accumulated suggesting that the
current limits of many PELs are not sufficiently protective. On October
10, 2014, OSHA published a Federal Register document in which it
recognized that many of its PELs are outdated and inadequate for
ensuring protection of worker health (79 FR 61384). In addition, health
standards issued under section 6(b)(5) of the OSH Act must reduce
significant risk only to the extent that it is technologically and
economically feasible to do so. OSHA's legal requirement to demonstrate
that its section 6(b)(5) standards are technologically and economically
feasible at the time they are promulgated often precludes OSHA from
imposing exposure control requirements sufficient to ensure that the
chemical substance no longer presents a significant risk to workers.
In sum, the great majority of OSHA's chemical standards are
outdated or do not sufficiently reduce significant risk to workers.
They would, in either case, be unlikely to address unreasonable risk to
workers within the meaning of TSCA, since TSCA section 6(b)
unreasonable risk determinations may account for unreasonable risk to
more sensitive endpoints and working populations than OSHA's risk
evaluations typically contemplate, and EPA is obligated to apply TSCA
section 6(a) risk management requirements to the extent necessary so
that the unreasonable risk is no longer presented.
Because the requirements and application of TSCA and OSHA
regulatory analyses differ, and because
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OSHA's chemical-specific standards are decades old and may include
outdated assumptions regarding the most sensitive end-point and/or the
technological and economic feasibility of the standards, it is
necessary for EPA to conduct risk evaluations and, where it finds
unreasonable risk to workers, develop risk management requirements for
chemical substances that OSHA also regulates, and it is expected that
EPA's findings and requirements may sometimes diverge from OSHA's.
However, it is also appropriate that EPA consider the chemical
standards that OSHA has already developed to limit the compliance
burden to employers by aligning management approaches required by the
agencies, where alignment will adequately address unreasonable risk to
workers. The following section discusses EPA's consideration of OSHA
standards in its risk evaluation and management strategies under TSCA.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
When characterizing the risk during risk evaluation under TSCA, EPA
believes it is appropriate to evaluate the levels of risk present in
scenarios where no mitigation measures are assumed to be in place for
the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It
should be noted that there are some cases where scenarios may reflect
certain mitigation measures, such as in instances where exposure
estimates are based on monitoring data at facilities that have existing
engineering controls in place.) In addition, EPA believes it is
appropriate to also evaluate the levels of risk present in scenarios
considering applicable OSHA requirements (e.g., chemical-specific PELs
and/or chemical-specific standards with PELs and additional ancillary
provisions), as well as scenarios considering industry or sector best
practices for industrial hygiene that are clearly articulated to the
Agency. By characterizing risks using scenarios that reflect different
levels of mitigation, EPA risk evaluations can help inform potential
risk management actions by providing information that could be used
during risk management to tailor risk mitigation appropriately to
address any unreasonable risk identified (see Unit II.C.2.b. and Unit
II.C.3.).
a. Risk Characterization for Unreasonable Risk Determination
When making unreasonable risk determinations as part of TSCA risk
evaluations, EPA cannot assume as a general matter that all workers are
always equipped with and appropriately using sufficient PPE, although
it does not question the public comments received on the 2020 Risk
Evaluation for Methylene Chloride regarding the occupational safety
practices often followed by industry respondents. When characterizing
the risk to human health from occupational exposures during risk
evaluation under TSCA, EPA believes it is appropriate to evaluate the
levels of risk present in baseline scenarios where PPE is not assumed
to be used by workers. This approach of not assuming PPE use by workers
considers the risk to potentially exposed or susceptible subpopulations
(workers and occupational non-users) who may not be covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by a State Plan. Mitigation scenarios included in
the EPA risk evaluation (e.g., scenarios considering use of PPE) likely
represent current practice in many facilities where companies
effectively address worker and bystander safety requirements. However,
the Agency cannot assume that all facilities will have adopted these
practices for the purposes of making the TSCA risk determination.
Therefore, EPA makes its determinations of unreasonable risk based
on scenarios that do not assume compliance with OSHA standards,
including any applicable exposure limits or requirements for use of
respiratory protection or other PPE. Making unreasonable risk
determinations based on such scenarios should not be viewed as an
indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread
noncompliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that unreasonable risk may exist for subpopulations of
workers that may be highly exposed because they are not covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by an OSHA State Plan, or because their employer is
out of compliance with OSHA standards, or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding existing OSHA
requirements.
b. Risk Evaluation To Inform Risk Management Requirements
In addition to the scenarios described previously, EPA risk
evaluations may characterize the levels of risk present in scenarios
considering applicable OSHA requirements (e.g., chemical-specific PELs
and/or chemical-specific health standards with PELs and additional
ancillary provisions) as well as scenarios considering industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency. EPA's evaluation of risk under scenarios
that, for example, incorporate use of engineering or administrative
controls, or PPE, serves to inform its risk management efforts.
Characterizing risks using scenarios that reflect different levels of
mitigation can help inform potential risk management actions by
providing information that could be used during risk management to
tailor risk mitigation to address worker exposures where the Agency has
found unreasonable risk. In particular, as discussed later in this
unit, EPA can use the information developed during its risk evaluation
to determine whether alignment of EPA's risk management requirements
with existing OSHA requirements or industry best practices will
adequately address unreasonable risk as required by TSCA.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
When undertaking risk management actions, EPA: (1) Develops
occupational risk mitigation measures to address any unreasonable risk
identified by EPA, striving for consistency with applicable OSHA
requirements and industry best practices, including appropriate
application of the National Institute for Occupational Safety and
Health (NIOSH) hierarchy of controls (Ref. 9) (hereafter referred to as
``hierarchy of controls''), when those measures would address an
unreasonable risk; and (2) Ensures that EPA requirements apply to all
potentially exposed workers in accordance with TSCA requirements.
Consistent with TSCA section 9(d), EPA consults and coordinates TSCA
activities with OSHA and other relevant Federal agencies for the
purpose of achieving the maximum applicability of TSCA while avoiding
the imposition of duplicative requirements.
Informed by the mitigation scenarios and information gathered
during the risk evaluation and risk management process, the Agency
might propose rules that require risk management practices that may be
already common practice in many or most facilities. Adopting clear,
comprehensive regulatory standards will foster compliance across all
facilities (ensuring a level playing field) and assure protections for
all affected workers, especially in cases where current OSHA standards
may not apply to them or not be sufficient to address the unreasonable
risk.
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4. Methylene Chloride and OSHA Requirements
EPA incorporated the considerations described earlier in this Unit
into the 2020 Risk Evaluation for Methylene Chloride, the November 2022
revised unreasonable risk determination for methylene chloride, and
this rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for
Methylene Chloride, EPA presented risk estimates based on workers'
exposures with and without respiratory protection. EPA determined that
even when respirators are used by workers, most of the conditions of
use evaluated presented an unreasonable risk. Additional considerations
of OSHA standards in the revised unreasonable risk determination are
discussed further in the Federal Register notice announcing that
document (Ref. 19) (87 FR 67901, November 10, 2022). In Units III.B.3.
and V., EPA outlines the importance of considering the hierarchy of
controls when developing risk management actions in general, and
specifically when determining if and how regulated entities may meet a
risk-based exposure limit for methylene chloride. The hierarchy of
controls is a prioritization of exposure control strategies from most
protective and preferred to least protective and preferred techniques.
In order of precedence, they are: elimination of the hazard,
substitution with a less hazardous substance, engineering controls,
administrative controls such as training or exclusion zones with
warning signs, and, finally, use of PPE (Ref. 9). Under the hierarchy
of controls, the use of respirators (and all PPE) should only be
considered after all other measures have been taken to reduce
exposures, and then under the context of the OSHA Respiratory
Protection Standard at 29 CFR 1910.134. As discussed in Units III.A.1.
and V.A.1., EPA's risk management approach would not rely solely or
primarily on the use of respirators to reduce exposures to workers so
that methylene chloride does not present unreasonable risk; instead,
EPA is proposing prohibitions for or affecting most conditions of use
and a WCPP for certain industrial and commercial uses. The WCPP would
require consideration of the hierarchy of controls before use of
respirators and other PPE. The WCPP is discussed in full in Units
IV.A.1. and V.A. As discussed further in Unit V.A.1., for many of the
conditions of use for which EPA is proposing a WCPP, data was submitted
during the risk evaluation and SBAR process that indicates some
facilities may already be in compliance with the proposed methylene
chloride ECEL.
In accordance with the approach described earlier in Unit II.C.3.,
EPA intends for this regulation to be as consistent as possible with
the current OSHA standard for methylene chloride, with additional
requirements as necessary to address the unreasonable risk. Notable
differences between the WCPP and the OSHA standard are the exposure
limits and the action levels. The WCPP would include an Existing
Chemical Exposure Limit (ECEL) of 2 ppm as an 8-hour TWA to address
unreasonable risk for chronic cancer and non-cancer inhalation
endpoints, and acute non-cancer endpoints, as well as an EPA Short Term
Exposure Limit (EPA STEL) of 16 ppm as a 15-minute TWA to address any
peak exposures which may result in additional unreasonable risk from
acute inhalation. A regulated entity must comply with both the 8-hour
TWA ECEL and the 15-minute TWA EPA STEL to completely address the
unreasonable risk. EPA recognizes that for methylene chloride, the ECEL
and EPA STEL would be significantly lower than the OSHA PEL (25 ppm as
an 8-hour TWA) and STEL (125 ppm). In addition to the distinctions in
statutory requirements described in this Unit, EPA has identified
factors contributing to the differences in these levels, outlined here
(Ref. 14).
EPA considers the methylene chloride ECEL to represent the best
available science under TSCA section 26(h), since it was derived from
information in the 2020 Risk Evaluation for Methylene Chloride, which
is the result of a rigorous systematic review process that investigated
the entirety of the reasonably available current literature in order to
identify all relevant adverse health effects. Additionally, by using
the information from the 2020 Risk Evaluation for Methylene Chloride,
the ECEL incorporates advanced modeling and peer-reviewed
methodologies, including accounting for exposures to potentially
exposed or susceptible subpopulations, as required by TSCA.
The ECEL is an 8-hour occupational inhalation exposure limit based
on the point of departure of the endpoint that drives the unreasonable
risk determination (chronic non-cancer liver effects, in the case of
methylene chloride), and takes into consideration the uncertainties
identified in the 2020 Risk Evaluation for Methylene Chloride (Ref.
11). The ECEL represents the concentration at or below which an adult
human, including a member of a potentially exposed or susceptible
subpopulation, would be unlikely to suffer adverse effects if exposed
for a working lifetime. EPA has determined as a matter of risk
management policy that ensuring exposures remain at or below the ECEL
will eliminate- any unreasonable risk of injury to health. In addition
to the ECEL, as part of this rulemaking, EPA is setting an ECEL-action
level, a value half of the ECEL, that would trigger additional
monitoring action to ensure that workers are not exposed to
concentrations above the ECEL.
The OSHA PEL is an 8-hour time-weighted average (TWA) based on an
employee's average airborne exposure in any 8-hour work shift of a 40-
hour work week that shall not be exceeded (Ref. 12). OSHA is required
to promulgate a standard that reduces significant risk to the extent
that it is technologically and economically feasible to do so (81 FR
16285).
For methylene chloride, the ECEL is based on the most sensitive
point of departure (POD) across acute, chronic non-cancer, and cancer
endpoints. As demonstrated in the ECEL memo, chronic liver toxicity is
the basis of the methylene chloride ECEL (Ref. 11). Both inhalation and
oral studies identified liver effects as sensitive non-cancer effects
linked with exposure to methylene chloride in animals. Overall, based
on limited human evidence and strong evidence in multiple animal
species from highly rated studies based on systematic review, the
weight of the scientific evidence supported EPA's finding that non-
cancer liver effects follow methylene chloride exposure.
EPA used liver lesions in rats as indicated by cellular
vacuolization in Nitschke et al., 1988 as the basis of the chronic non-
cancer POD. Study data was run through a physiological-based
pharmacokinetic (PBPK) model to more accurately account for both inter-
species differences and human variability. Internal PBPK-modeled doses
were also benchmark-dose modeled in order to better refine the POD
estimate, resulting in a human equivalent concentration (HEC) of 4.8
ppm based on continuous exposure with a benchmark margin of exposure
(MOE) (equal to the product of all uncertainty factors) of 10. The
resulting ECEL is 2 ppm.
The EPA STEL is based on decreased visual performance identified in
an acute inhalation study on human subjects. Putz et al. (1979) is a
well-conducted study of 12 volunteers that identified decreased visual
peripheral performance after 1.5 hour of exposure to 195 ppm (200 ppm
nominal) (Ref. 13). Because this study used a single concentration, it
is not amenable to dose-response modeling, so EPA used
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the lowest observed adverse effects concentration (LOAEC) of 195 ppm.
Adjusting to a more appropriate exposure duration of 8-hour for
occupational scenarios resulted in a HEC of 80 ppm with benchmark MOE
of 30. The resulting acute exposure limit is 16 ppm, eight times higher
than the overall ECEL.
The OSHA PEL for methylene chloride was adopted in 1971 and updated
in 1997 (62 FR 1494, January 10, 1997). The OSHA PEL is set at 25 ppm,
based on cancer from the same National Toxicology Program (1986) study
cited for cancer effects in the 2020 Methylene Chloride Risk Evaluation
(Ref. 14) (though EPA found this was not the most sensitive POD, and
thus set an ECEL of 2 ppm, based on non-cancer liver effects from
Nitschke et al., 1988 (Refs. 15, 16)).
The OSHA PEL utilized a PBPK model to derive lifetime excess risk
estimates for cancer. The PEL was set at 25 ppm based on estimated
lifetime risk of 2.4 to 3.6 cases per 1000 or 2.4-3.66x10-3
(E-3) at that exposure level. EPA used a benchmark of 1 in
10,000 (10-4) for individuals in industrial and commercial
work environments for purposes of the unreasonable risk determination
for methylene chloride (Ref. 2), and at that cancer risk level EPA
calculates the exposure limit based on cancer to be approximately 42
ppm--almost double the OSHA PEL. OSHA acknowledges that the
10-3 threshold is ``100 to 1000 times higher than the risk
levels generally regarded by other Federal Agencies as on the boundary
between significant and insignificant risk'' and notes that ``even at
the final PELs, the risks to workers clearly remain significant.'' (62
FR 1494, January 10, 1997).The 1997 decision to not derive a PEL lower
than 25 ppm was based on economic and technical analysis, with OSHA
stating, ``because of the lack of documented feasibility data for
potential PELs of less than 25 ppm, OSHA has concluded that there is
not enough information available to support lowering the 8-hour TWA PEL
or STEL further at this time'' (62 FR 1494, January 10, 1997).
As for non-cancer liver effects that are the basis of the ECEL,
OSHA determined that ``chronic exposure to [methylene chloride] caused
toxic effects in rat and mouse liver and cancer in mouse liver. These
studies appear to have been well conducted and the differences in
toxicity observed across studies were likely due to differences in dose
or route of exposure . . . [L]imited evidence supports the hypothesis
that [methylene chloride] causes human hepatotoxicity, based on the
data in the Ott study. The remaining studies and case reports do not
provide clear evidence of a causative role of [methylene chloride] in
hepatotoxicity. The Agency [OSHA] has set the exposure limits based on
cancer and [central nervous system] effects and has not reached final
conclusions on this issue'' (62 FR 1514-1515, January 10, 1997). As
discussed in Units II.D., III.B.A., and VII.D., the ECEL represents the
best available science at time of publication of the 2020 Risk
Evaluation for Methylene Chloride.
D. 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.2.
The 2020 Risk Evaluation for Methylene Chloride identified significant
adverse health effects associated with short- and long-term exposure to
methylene chloride, including central nervous system effects up to and
including death from acute inhalation exposures, non-cancer liver
effects from chronic inhalation, and cancer from chronic inhalation
exposures to methylene chloride, as well as acute central nervous
system effects and chronic non-cancer liver effects from dermal
exposure. A further discussion of the hazards of methylene chloride is
in Unit III.B.1.
2. 2022 Revised Unreasonable Risk Determination
EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the methylene chloride
risk evaluation, to ensure that the risk evaluations upon which risk
management decisions are made better align with TSCA's objective of
protecting health and the environment. For methylene chloride, 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. 17, 18, 19). The revisions consisted
of making the risk determination based on the whole-chemical substance
instead of by individual conditions of use (which resulted in the
revised risk determination superseding the prior ``no unreasonable
risk'' determinations (Ref. 2) the withdrawal of the associated TSCA
section 6(i)(1) ``no unreasonable risk'' order; and clarifying that the
risk determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE (Ref. 2).
In determining whether methylene chloride presents unreasonable
risk under the conditions of use, EPA considered relevant risk-related
factors, including, but not limited to: the effects of the chemical
substance on health (including cancer and non-cancer risks) and human
exposure to the substance under the conditions of use (including
duration, magnitude and frequency of exposure); the effects of the
chemical substance on the environment and environmental exposure under
the conditions of use; the population exposed (including any
potentially exposed or susceptible subpopulations); the severity of
hazard (including the nature of the hazard, the irreversibility of the
hazard); and uncertainties.
[[Page 28292]]
EPA determined that methylene chloride presents an unreasonable
risk of injury to health. The unreasonable risk determination is driven
by risks to workers and occupational non-users (workers who do not
directly handle methylene chloride but perform work in an area where
methylene chloride is present) from occupational exposures (i.e.,
during manufacture, processing, industrial and commercial uses, or
disposal), and to consumers and bystanders from consumer use of
methylene chloride. EPA did not identify risks of injury to the
environment that drive 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., with descriptions to aid chemical
manufacturers, processors, and users in determining how their
particular use or activity would be addressed under the proposed
regulatory provisions.
While the 2020 Risk Evaluation for Methylene Chloride estimated
different risks for occupational non-users and workers, the benchmark
(and thus the ECEL and EPA STEL value) is the same for both
populations. That is, while workers and occupational non-users may have
different exposure patterns, the level of exposure such that risks are
no longer unreasonable is the same for both workers and occupational
non-users. Thus, for the purposes of risk management, the distinction
between worker and occupational non-user is no longer relevant, and
both are encompassed by the definition of a potentially exposed person,
as outlined in Unit IV.A.1.a. EPA additionally emphasizes that the
inclusion of occupational non-users itself does not exceed the scope of
those individuals that are already covered by the OSHA PEL, as the
methylene chloride OSHA standard applies to all employees within a
regulated area, regardless of whether they directly handle methylene
chloride.
3. Fenceline Screening Analysis
The 2020 TSCA Risk Evaluation for Methylene Chloride excluded the
assessment of certain exposure pathways that were or could be regulated
under another EPA-administered statute (see section 1.4.2 of the 2020
Risk Evaluation for Methylene Chloride (Refs. 1, 2)). This resulted in
the surface water, drinking water, and ambient air pathways for
methylene chloride exposure not being assessed for human health risk to
the general population. In June 2021, EPA made a policy announcement on
the path forward for TSCA chemical risk evaluations, indicating that
EPA would, among other things, examine whether the exclusion of certain
exposure pathways from the risk evaluations would lead to a failure to
identify and protect fenceline communities (Refs. 10, 20).
In order to assess the potential for risk to the general population
in proximity to a facility releasing methylene chloride, EPA developed
the TSCA Screening Level Approach for Assessing Ambient Air and Water
Exposures to Fenceline Communities Version 1.0, which was presented to
the SACC in March 2022, with a report issued by the SACC on May 18,
2022 (Ref. 21). This analysis is discussed in Unit VI.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines, in
accordance with TSCA section 6(b)(4)(A), that the manufacture
(including import), processing, distribution in commerce, use, or
disposal of a chemical substance or mixture, or any combination of such
activities, presents an unreasonable risk of injury to health or the
environment, EPA must by rule apply one or more of the following
requirements to the extent necessary so that the chemical substance or
mixture no longer presents such risk.
Prohibit or otherwise restrict the manufacturing
(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)).
As described in Unit III.B., EPA assessed how the TSCA section 6(a)
requirements could be applied to address the unreasonable risk found to
be present in the 2020 Risk Evaluation for Methylene Chloride and the
final revised unreasonable risk determination, so that methylene
chloride no longer presents such unreasonable risk. EPA's proposed
regulatory action and a primary alternative regulatory action are fully
discussed in Unit IV. EPA is requesting public comment on the proposed
regulatory action and primary alternative regulatory action.
Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption for a specific condition of use for which EPA
finds that: (1) The specific condition of use is a critical or
essential use for which no technically and economically feasible safer
alternative is available, taking into consideration hazard and
exposure; (2) Compliance with the requirement would significantly
disrupt the national economy, national security, or critical
infrastructure; or (3) The specific condition of use, as compared to
reasonably available alternatives, provides a substantial benefit to
health, the environment, or public safety. Further, the Administrator
may by rule, extend, modify, or eliminate an exemption if the
Administrator determines, on the basis of reasonably available
information and after adequate public justification, the exemption
warrants extension or modification or is no longer necessary. Based on
reasonably available information, EPA has considered the issue and is
proposing that a TSCA section 6(g) exemption is warranted for certain
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conditions of use, as detailed in Unit IV.A.5. EPA is requesting
comment on the proposed rule's section 6(g) exemption provisions and
rationale.
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
section 6(a) rules, to consider and include a statement of effects
addressing certain factors, including the costs and benefits and the
cost effectiveness of the proposed regulatory action and of the one or
more primary alternative regulatory actions considered by the
Administrator. Also, under TSCA section 6(c)(2), EPA must consider the
effects of the chemical substance or mixture on health or the
environment and the magnitude of the exposure, which can include
impacts to health or the environment in fenceline communities. TSCA
section 6(c)(2) considerations are discussed in Unit VI.
TSCA section 6(c)(2)(C) requires that, in deciding whether to
prohibit or restrict in a manner that substantially prevents a specific
condition of use and in setting an appropriate transition period for
such action, EPA consider, to the extent practicable, whether
technically and economically feasible alternatives that benefit health
or the environment will be reasonably available as a substitute when
the proposed prohibition or restriction takes effect. Unit III.B.4.
includes more information regarding EPA's consideration of
alternatives, and Unit V. provides more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
As described in this Unit, EPA carried out required consultations
as described later in this unit and also considered impacts on
children's environmental health as part of its approach to developing
this TSCA section 6 regulatory action.
1. Consultations
EPA conducted consultations and outreach as part of development of
this proposed regulatory action. The Agency held a federalism
consultation from October 22, 2020, until January 23, 2021, as part of
this rulemaking process and pursuant to Executive Order 13132. This
included a background presentation on September 9, 2020, and a
consultation meeting on October 22, 2020. During the consultation, EPA
met with State and local officials early in the process of developing
the proposed action in order to receive meaningful and timely input
into its development (Ref. 22). During the consultation, participants
and EPA discussed preemption, EPA's authority under TSCA section 6 to
regulate identified unreasonable risk, what activities would be
potentially regulated in the proposed rule, and the relationship
between TSCA and existing statutes--particularly the Clean Water Act
(CWA) and Safe Drinking Water Act (SDWA) (Ref. 22).
Methylene chloride is not manufactured (including imported),
processed, distributed in commerce, or regulated by Tribal governments.
However, EPA consulted with Tribal officials during the development of
this proposed action (Ref. 23). 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 risk managers concerning the current
status of risk management. During the consultation, EPA discussed risk
management under TSCA section 6(a), findings from the 2020 Risk
Evaluation for Methylene Chloride, types of information that would be
helpful to inform risk management, principles for transparency during
the risk management process, and types of information EPA is seeking
from Tribes (Ref. 23). EPA received no written comments as part of this
consultation.
In addition to the formal consultations, EPA also conducted
outreach to advocates for communities that might be subject to
disproportionate exposure to methylene chloride, including
underrepresented communities such as minority populations, low-income
populations, and Indigenous peoples. EPA's Environmental Justice (EJ)
consultation occurred from November 4, 2020, through January 18, 2021.
On November 16 and 19, 2020, EPA held public meetings as part of this
consultation. These meetings were held pursuant to and in compliance
with Executive Orders 12898 and 14008. EPA received three written
comments following the EJ meetings, in addition to oral comments
provided during the consultations (Refs. 24, 25, 26). 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 in regulating methylene chloride, favored
prohibitions, and noted the uncertainties associated with use of PPE
(e.g., in some cases, use of PPE did not provide adequate protection
given the exposure scenario).
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 are in Unit X.C. and in the Initial Regulatory
Flexibility Analysis (Ref. 27); the Panel report is in the docket (Ref.
6).
Units X.C., X.E., X.F., and X.J. provide more information regarding
the consultations.
2. Other Stakeholder Consultations
In addition to the formal consultations described in Unit X., EPA
attended a Small Business Administration (SBA) Office of Advocacy
Environmental Roundtable on September 11, 2020 and held a public
webinar on September 16, 2020. At both events EPA staff provided an
overview of the TSCA risk management process and the findings in the
2020 Risk Evaluation for Methylene Chloride (Ref. 28). Attendees of
these meetings were given an opportunity to voice their concerns
regarding the risk evaluation and risk management.
Furthermore, EPA has engaged in discussions with representatives
from different industries, non-governmental organizations, technical
experts, and users of methylene chloride. A list of external meetings
held during the development of this proposed rule is in the docket
(Ref. 29); meeting materials and summaries are also in the docket. The
purpose of these discussions was to hear from users, academics,
manufacturers, and members of the public health community about
practices related to commercial and consumer uses of methylene
chloride; public health impacts of methylene chloride; the importance
of methylene chloride in the various uses subject to this proposed
rule; frequently used substitute chemicals or alternative methods;
engineering control measures and PPE currently in use or feasibly
adoptable; and other risk-reduction approaches that may have already
been adopted or considered for industrial, commercial or consumer uses.
3. Children's Environmental Health
The Agency's 2021 Policy on Children's Health (Ref. 30) 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
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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).
The 2020 Risk Evaluation for Methylene Chloride evaluated exposures
of infants, toddlers, older children (11 to 15 years and 16 to 20
years), and males and females of reproductive age; while EPA identified
exposures to these populations (as bystanders, consumers, or workers)
as driving the unreasonable risk for methylene chloride, EPA did not
find that the adverse health impacts for these groups 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 (Ref. 1).
More specifically, the 2020 Risk Evaluation for Methylene Chloride
released in June 2020 considered impacts on both children and adults
from occupational and consumer use from inhalation and dermal
exposures, as applicable. For occupational use, the risk evaluation
considered males (>16 years of age) and females of reproductive age
(>16 years of age to less than 50 years of age) for both dermal and
inhalation exposures. For consumer use, EPA evaluated dermal exposures
for children ages 11 to 15 and 16 to 20 years of age, and the
evaluation of bystander exposure from inhalation exposures included
infants, toddlers and older children. While risks to children are not
disproportionate, effects observed in studies include central nervous
system impairment from acute inhalation exposure and liver toxicity
from chronic inhalation exposure. The risks described in this section
would be addressed by the proposed regulatory action described in Unit
IV.
B. Regulatory Assessment of Methylene Chloride
1. Description of Conditions of Use
This Unit describes the TSCA conditions of use that drive the
unreasonable risk for methylene chloride. Condition of use descriptions
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 acknowledges that some of the
terms here may be defined under other statutes; however, the
descriptions in this unit are intended to provide clarity to the
regulated entities who will implement the provisions of this rulemaking
under TSCA section 6(a).
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 Solvent for Batch Vapor Degreasing
This condition of use refers to the process of heating methylene
chloride to its volatilization point and using its vapor to remove
dirt, oils, greases, and other surface contaminants (such as drawing
compounds, cutting fluids, coolants, solder flux, and lubricants) from
metal parts, electronics, or other articles in batch open-top vapor
degreasers or closed-loop vapor degreasing in industrial or commercial
settings.
ii. Industrial and Commercial Use as Solvent for In-line Vapor
Degreasing
This condition of use refers to the process of heating methylene
chloride to its volatilization point and using its vapors to remove
dirt, oils, greases, and other surface contaminants from textiles,
glassware, metal surfaces, and other articles using conveyorized or
continuous-web vapor degreasing machines in industrial or commercial
settings.
iii. Industrial and Commercial Use as Solvent for Cold Cleaning
This condition of use refers to the industrial or commercial use of
methylene chloride as a non-boiling solvent in cold-cleaning to
dissolve oils, greases, and other surface contaminants from textiles,
glassware, metal surfaces, and other articles.
iv. Industrial and Commercial Use as Solvent for Aerosol Spray
Degreaser/Cleaner
This condition of use refers to industrial or commercial use of
methylene chloride in aerosol degreasing as an aerosolized solvent
spray, typically applied from a pressurized can, to remove residual
contaminants from fabricated parts or machinery (including circuit
boards and electronics).
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v. Industrial and Commercial Use in Adhesives, Sealants, and Caulks
This condition of use refers to industrial or commercial use of
methylene chloride in adhesives, sealants, and caulks to promote
bonding between other substances, promote adhesion of surfaces, or
prevent seepage of moisture or air.
vi. Industrial and Commercial Use in Paints and Coatings
This condition of use refers to industrial or commercial use of
methylene chloride in paints or coatings applied to surfaces, usually
to enhance properties such as water repellency, gloss, fade resistance,
ease of application, or foam prevention, etc.
vii. Industrial and Commercial Use in Paint and Coating Removers
This condition of use refers to industrial or commercial use of
methylene chloride or methylene chloride-containing products applied to
surfaces to remove paint, coatings, and other finishes and to clean the
underlying surface, including but not limited to furniture refinishing.
viii. Industrial and Commercial Use in Adhesive and Caulk Removers
This condition of use refers to industrial or commercial use of
methylene chloride in products in industrial or commercial settings
applied to surfaces to unbind substances or remove sealants and to
clean the underlying surface by softening adhesives, caulks, and other
glues so they can be removed.
ix. Industrial and Commercial Use in Metal Aerosol Degreasers
This condition of use refers to the industrial or commercial use of
methylene chloride in aerosol degreasing as an aerosolized solvent
spray, typically applied from a pressurized can, to remove residual
contaminants from fabricated parts, machinery, or other metal
substrate.
x. Industrial and Commercial Use in Metal Non-Aerosol Degreasers
This condition of use refers to the industrial or commercial use of
methylene chloride in liquid degreasing to remove residual contaminants
from fabricated parts, machinery, or other metal substrate.
xi. Industrial and Commercial Use in Finishing Products for Fabric,
Textiles, and Leather
This condition of use refers to industrial or commercial use of
methylene chloride in the finishing of fabrics at fabric or textile
mills, including in products that impart color or other desirable
properties to fabrics or textiles. The methylene chloride may be added
during the manufacturing of the textile or during the finishing, such
as pressing of the fabric.
xii. Industrial and Commercial Use in Automotive Care Products
(Functional Fluids for Air Conditioners)
This condition of use refers to the industrial or commercial use of
methylene chloride for one or more operational properties in a closed
system in products intended for automotive care and includes automotive
air conditioner refrigerant and as a refrigerant with stop leak
sealant.
xiii. Industrial and Commercial Use in Automotive Care Products
(Interior Car Care)
This condition of use refers to the industrial or commercial use of
methylene chloride in cleaning agents used to remove stains from
interior carpets and textiles in automotive vehicles.
xiv. Industrial and Commercial Use in Automotive Care Products
(Degreasers)
This condition of use refers to the industrial or commercial use of
methylene chloride in liquid or aerosol degreasing to remove residual
contaminants from automotive substrates and articles.
xv. Industrial and Commercial Use in Apparel and Footwear Care Products
This condition of use refers to the industrial or commercial use of
methylene chloride in apparel and footwear care products as post-market
waxes, polishes, or other media and applied to footwear, textiles, or
fabrics to impart color or other desirable properties.
xvi. Industrial and Commercial Use in Spot Removers for Apparel and
Textiles
This condition of use refers to the industrial or commercial use of
methylene chloride or methylene chloride-containing products applied
from squeeze bottles, hand-held spray bottles, or spray guns, either
before or after a cleaning cycle on apparel and textiles. After
application, the methylene chloride or product is removed by manually
scraping or flushing away the stain by using a brush, spatula,
pressurized air, or steam.
xvii. Industrial and Commercial Use in Liquid Lubricants and Greases
This condition of use refers to the industrial or commercial use of
methylene chloride in liquids that reduce friction, heat generation,
and wear between surfaces.
xviii. Industrial and Commercial Use in Spray Lubricants and Greases
This condition of use refers to the industrial or commercial use of
methylene chloride in sprays that reduce friction, heat generation, and
wear between surfaces.
xix. Industrial and Commercial Use in Aerosol Degreasers and Cleaners
This condition of use refers to the industrial or commercial use of
methylene chloride in aerosol degreasing as an aerosolized solvent
spray, typically applied from a pressurized can, to remove residual
contaminants from a fabricated part or other substrate.
xx. Industrial and Commercial Use in Non-Aerosol Degreasers and
Cleaners
This condition of use refers to the industrial or commercial use of
methylene chloride in liquid degreasing to remove residual contaminants
(such as oils, greases, and similar materials) from a fabricated part
or other substrate (such as textiles, glassware, products, and other
articles).
xxi. Industrial and Commercial Use in Cold Pipe Insulations
This condition of use refers to the industrial or commercial use of
methylene chloride when typically applied in aerosolized form in
products used in building and construction materials to provide
insulation.
xxii. Industrial and Commercial Use as a Solvent That Becomes Part of a
Formulation or Mixture
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.
xxiii. 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
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function of a substance or article created.
xxiv. Industrial and Commercial Use as Propellant and Blowing Agent
This condition of use refers to the industrial or commercial use of
methylene chloride in the production of polyurethane foam including as
a blowing agent and as a solvent for cleaning equipment.
xxv. 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. In response to a request
for clarification, EPA agrees that use of methylene chloride in a
closed-loop chiller system used to perform FAA-required aviation fuel
testing is considered industrial and commercial use as a laboratory
chemical (Ref. 31). The analogous use of methylene chloride in a
chiller system in the Department of Defense McKinley Climactic
Laboratory would likewise be considered industrial and commercial use
as a laboratory chemical.
xxvi. Industrial and Commercial Use for Electrical Equipment,
Appliance, and Component Manufacturing
This condition of use refers to the industrial or commercial use of
methylene chloride in electrical and electronic products; their
maintenance; their manufacture, such as in the production of printed
circuit boards; and at wholesalers and retail stores.
xxviii. 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.
xxix. Industrial and Commercial Use in Cellulose Triacetate Film
Production
This condition of use refers to the industrial or commercial use of
methylene chloride as a chemical processor for polycarbonate resins and
cellulose triacetate (photographic film).
xxx. Industrial and Commercial Use as Anti-Spatter Welding Aerosol
This condition of use refers to the industrial or commercial use of
methylene chloride in formulations to prevent spatter from adhering to
metal surfaces during welding.
xxxi. Industrial and Commercial Use for Oil and Gas Drilling,
Extraction, and Support Activities
This condition of use refers to the industrial or commercial use of
methylene chloride in the extraction, development, and preparation of
oil, liquid crude petroleum, and gas. Activities may include
exploration for crude petroleum and natural gas, core sampling,
drilling wells, operating separator, emulsion breakers, and distilling
equipment.
xxxii. Industrial and Commercial Use for Toys, Playgrounds, and
Sporting Equipment
This condition of use refers to the industrial or commercial use of
methylene chloride in the manufacture of toys intended for children's
use (and child-dedicated articles), including fabrics, textiles, and
apparel (which may include stuffed toys, blankets, or comfort objects)
as well as plastic articles (hard) (which may include dolls, toy cars,
toy animals, or teething rings).
xxxiii. Industrial and Commercial Use in Lithographic Printing Plate
Cleaner
This condition of use refers to the industrial or commercial use of
methylene chloride in lithographic printing for the cleaning of plates
and rollers.
xxxiv. Industrial and Commercial Use in Carbon Remover, Wood Floor
Cleaner, and Brush Cleaner
This condition of use refers to the industrial or commercial use of
methylene chloride in formulated products to remove carbon and other
dirt and residues from a variety of surfaces including floors and
brushes.
d. Consumer Uses
i. Consumer Use as a Solvent in Aerosol Degreasers/Cleaners
This condition of use refers to consumer use of products containing
methylene chloride as a solvent for cleaning or degreasing in the form
of an aerosol spray degreaser or cleaner. The products are used to
dissolve oils, greases, and similar materials from textiles, glassware,
metal surfaces, and other articles.
ii. Consumer Use in Adhesives and Sealants
This condition of use refers to consumer use of methylene chloride
in single or two-component products used to fasten other materials
together or prevent the passage of liquid or gas.
iii. Consumer Use in Brush Cleaners for Paints and Coatings
This condition of use refers to consumer use of products containing
methylene chloride to clean brushes after using them to apply paints or
coatings.
iv. Consumer Use in Adhesive and Caulk Removers
This condition of use refers to consumer use of products containing
methylene chloride to remove, loosen, or deteriorate any adhesive or
caulk from a substrate, such as floor adhesive removal.
v. Consumer Use in Metal Degreasers
This condition of use refers to consumer use of products containing
methylene chloride for the degreasing of metals, such as coil cleaners
and electronics cleaners.
vi. Consumer Use in Automotive Care Products (Functional Fluids for Air
Conditioners)
This condition of use refers to consumer use of products containing
methylene chloride for automotive care and includes automotive air
conditioner refrigerant and leak sealant.
vii. Consumer Use in Automotive Care Products (Degreasers)
This condition of use refers to consumer use of products containing
methylene chloride for automotive care and includes products for
degreasing automotive parts, such as brakes, carburetors, engines, and
gaskets.
viii. Consumer Use in Lubricants and Greases
This condition of use refers to consumer use of products containing
methylene chloride to reduce friction, heat generation, and wear
between solid surfaces, such as engines and brakes.
ix. Consumer Use in Cold Pipe Insulation
This condition of use refers to consumer use of products containing
methylene chloride used in building and construction materials to
provide insulation.
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x. Consumer Use in Arts, Crafts, and Hobby Materials Glue
This condition of use refers to consumer use of arts, crafts, and
hobby materials, such as glues, containing methylene chloride.
xi. Consumer Use in an Anti-Spatter Welding Aerosol
This condition of use refers to consumer use of products containing
methylene chloride to prevent the spatter of the welding from sticking
to welding material or a nearby surface (for example, workbenches).
xii. Consumer Use in Carbon Removers and Other Brush Cleaners
This condition of use refers to consumer use of products containing
methylene chloride for cleaning applications to remove carbon, inks and
paints, grease, or other foreign matter. The cleaning operations
include carbon removers (for example, to clean appliances, pots, and
pans) and other applications that usually involve the use of a brush
(for example, in lithographic printing cleaners, in taxidermy, and in
wood and floor cleaners).
e. 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.
f. Terminology in This Proposed Rule
For the purposes of this proposed rulemaking, ``occupational
conditions of use'' refers to the TSCA conditions of use described in
Units III.B.1.a, b, c, and e. Although EPA identified both industrial
and commercial uses in the 2020 Risk Evaluation for Methylene Chloride
for purposes of distinguishing scenarios, the Agency clarified then and
clarifies now that EPA interprets the authority Congress gave to the
Agency to ``regulat[e] any manner or method of commercial use'' under
TSCA section 6(a)(5) to reach both industrial and commercial uses.
Additionally, in the 2020 Risk Evaluation for Methylene Chloride,
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)). EPA determined that all
industrial, commercial, and consumer use of methylene chloride
evaluated in the 2020 Risk Evaluation for Methylene Chloride drives the
unreasonable risk of injury to health. As such, for purposes of this
risk management rulemaking, ``consumer use'' refers to all known,
intended, or reasonably foreseen methylene chloride consumer uses.
Likewise, for the purpose of this risk management rulemaking,
``industrial and commercial use'' refers to all known, intended, or
reasonably foreseen methylene chloride industrial and commercial use.
EPA further notes that this proposed rule does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but
are not limited to, any pesticide (as defined by the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured,
processed, or distributed in commerce for use as a pesticide; and any
food, food additive, drug, cosmetic, or device, as defined in section
201 of the Federal Food, Drug, and Cosmetic Act, when manufactured,
processed, or distributed in commerce for use as a food, food additive,
drug, cosmetic or device.
EPA is not proposing to incorporate the descriptions in Units
III.B.1.a through III.B.1.e. into the regulatory text as definitions.
EPA requests comment on whether a definition should be promulgated for
each condition of use of methylene chloride and, if so, whether the
descriptions in this Unit are consistent with the conditions of use
evaluated in the 2020 Risk Evaluation for Methylene Chloride and
whether they provide a sufficient level of detail such that they would
improve the clarity and readability of the regulation if promulgated.
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that methylene chloride presents an unreasonable
risk of injury to human health under the conditions of use based on
acute and chronic non-cancer risks and chronic cancer risks. 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. However, EPA also 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 endpoint for risk management, EPA's action will
also eliminate the unreasonable risks from acute, chronic non-cancer
and cancer endpoints from 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 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.
32). Eighty-five occupational 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; there has been no linear trend
indicating a decrease in fatalities during that time period (Ref. 32).
In some instances, while workers were wearing respirators, the
respirators were inadequate to protect against methylene chloride
inhalation exposure (Ref. 32). Unit VI.A. summarizes the health effects
and the magnitude of the exposures in more detail.
To make the unreasonable risk determination for methylene chloride,
EPA evaluated exposures to workers, occupational non-users, consumer
users, and bystanders using reasonably available monitoring and
modeling data for inhalation and dermal exposures. In addition, EPA
conducted a screening level analysis to assess risks from the air and
water pathways to fenceline communities. A discussion of EPA's analysis
and the expected effects of this rulemaking on fenceline communities is
in Unit VI.A.
For the 2020 Risk Evaluation for Methylene Chloride, EPA considered
potentially exposed or susceptible subpopulations identified as
relevant to the risk evaluation by the Agency. There are several groups
of individuals with greater exposure to methylene chloride relative to
the general population, including: (1) Workers and occupational non-
users, and (2) Consumer users and bystanders to consumer use of
products containing methylene chloride (Ref. 1). EPA also identified
several human subpopulations which may have greater susceptibility than
the general population to the hazards of methylene chloride, including
individuals with
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certain genetic polymorphisms (variant forms of a specific DNA
sequence) that may make them more susceptible to getting cancer from
methylene chloride, and individuals with cardiac disease and other
comorbidities, who may be at increased risk for angina from acute
exposures (Ref. 1). All potentially exposed or susceptible
subpopulations are included in the quantitative and qualitative
analyses described in the 2020 Risk Evaluation for Methylene Chloride
and were considered in the determination of unreasonable risk for
methylene chloride. As discussed in Units II.D. and VI.A., the 2020
Risk Evaluation for Methylene Chloride excluded the air and water
exposure pathways from the published risk evaluations and may have
caused some risks to be unaccounted for in the risk evaluation. EPA
considers receptors exposed to methylene chloride through those
pathways to constitute a subset of the general population and
categorizes them as fenceline communities; they may also be considered
potentially exposed or susceptible subpopulations. See Unit VI.A. for
further discussion on assessing and protecting risk to fenceline
communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to eliminate the
unreasonable risk from methylene chloride. This Unit summarizes the
TSCA section 6 considerations for issuing regulations under TSCA
section 6(a). Unit V. outlines how EPA applied these considerations
specifically to managing the unreasonable risk from 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. To identify and select a regulatory
action, EPA considered the two routes of exposure driving the
unreasonable risk, inhalation and dermal, and the exposed populations.
For occupational conditions of use (see Unit III.B.1.f.), EPA
considered how it could directly regulate manufacturing (including
import), processing, distribution in commerce, industrial and
commercial use, or disposal to address the unreasonable risk. EPA does
not have direct authority to regulate consumer use. Therefore, EPA
considered how it could exercise its authority under TSCA to regulate
the manufacturing (including import), processing, and/or distribution
in commerce of 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) requirements. To the extent
practicable, EPA factored into its decisions: (i) the effects of
methylene chloride on health and the environment, (ii) the magnitude of
exposure to methylene chloride of human beings and the environment,
(iii) the benefits of methylene chloride for various uses, and (iv) the
reasonably ascertainable economic consequences of the rule. In
evaluating the reasonably ascertainable economic consequences of the
rule, EPA considered (1) The likely effect of the rule on the national
economy, small business, technological innovation, the environment, and
public health; (2) The costs and benefits of the proposed regulatory
action and one or more primary alternative regulatory actions
considered; and (3) The cost effectiveness of the proposed regulatory
action and of the one or more primary alternative regulatory actions
considered. TSCA section 6(c)(2)(A) considerations for methylene
chloride are discussed in full in Unit VI., including the statement of
effects of the proposed rule with respect to these considerations.
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 for all or part of this risk management
action to be addressed 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.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit III.B.4.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1)(B) (described
in the proposed and alternative regulatory action in Unit IV.).
To the extent information was reasonably available, EPA considered
pollution prevention strategies and the hierarchy of controls adopted
by OSHA and NIOSH, as discussed in Unit II.C.4., when selecting
regulatory actions, with the goal of identifying risk management
control methods that are permanent, feasible, and effective. EPA also
considered how to address the unreasonable risk while providing
flexibility to the regulated community where appropriate, and took into
account the information presented in the 2020 Risk Evaluation for
Methylene Chloride, as well as input from stakeholders (as described in
Unit III.A.) and anticipated compliance strategies from regulated
entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory action described
in Unit IV. Additional details related to how the requirements in this
Unit were incorporated into development of those actions are in Unit V.
As demonstrated by the number of distinct programs addressed in
this rulemaking and the structure of this proposed rule in addressing
them independently, EPA generally intends the rule's provisions to be
severable from each other. EPA expects to provide additional detail on
severability in the final rule once the Agency has considered public
comments and finalized the regulatory language.
IV. Proposed Regulatory and Alternative Regulatory Actions
This Unit describes the proposed regulatory action by EPA so that
methylene chloride will no longer present an unreasonable risk of
injury to health. In addition, as indicated by TSCA section 6(c)(2)(A),
EPA must consider the costs and benefits and the cost-effectiveness of
the proposed regulatory action and one or more primary alternative
regulatory actions. In the case of methylene chloride, the proposed
regulatory action is described in Unit IV.A. and the alternative
regulatory action considered is described in Unit IV.B. An overview of
the proposed regulatory action and primary alternative regulatory
action for each condition of use is in Unit IV.C.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to: Require a WCPP,
including inhalation exposure concentration limits and related
monitoring, for ten conditions of use, outlined in Unit IV.A.1.;
Prohibit most industrial and commercial use of methylene chloride,
outlined in Unit IV.A.2.; Prohibit the
[[Page 28299]]
manufacture, processing, and distribution in commerce of methylene
chloride for all consumer use (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), outlined in
Unit IV.A.3.; Establish recordkeeping and downstream notification
requirements, outlined in Unit IV.A.4.; and Provide a 10-year, time-
limited exemption under TSCA section 6(g) for paint and coating removal
by civilian aviation from a prohibition that would significantly
disrupt critical infrastructure, as outlined in Unit IV.A.5., with
conditions for this exemption to include compliance with the WCPP
described in Unit IV.A.1.
1. Workplace Chemical Protection Program (WCPP)
a. Overview
As described in Unit I., under TSCA section 6(a), 15 U.S.C.
2605(a), EPA is required to issue a regulation applying one or more of
the TSCA section 6(a) requirements to the extent necessary so that the
unreasonable risk of injury to human health or the environment from a
chemical substance is no longer presented. The TSCA section 6(a)
requirements provide EPA the authority to limit or prohibit a number of
activities, including, but not limited to, restricting or regulating
the manufacture, processing, distribution in commerce, commercial use,
or disposal of the chemical substance. Given this statutory authority,
EPA may find it appropriate in certain circumstances to propose a WCPP
for certain occupational (i.e., industrial and commercial) conditions
of use. 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 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. EPA's intention is to require a comprehensive WCPP
that would 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 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 described in Units III.B.1.a. through
III.B.1.e. and subject to the WCPP is occurring. The term includes any
person who owns, leases, operates, controls, or supervises such a
workplace.
EPA is proposing a 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 or commercial use
for paint and coating removal from safety-critical, corrosion-sensitive
components of aircraft and spacecraft 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 applications by Federal agencies and their
contractors; and disposal (EPA's rationale is provided in Unit V.). EPA
is additionally proposing to require that uses receiving an exemption
under TSCA section 6(g), as outlined in Unit IV.A.5., comply with the
WCPP. EPA is proposing that these requirements take effect 180 days
after publication of the final rule, at which point entities would be
required to conduct initial monitoring (as described in Unit
IV.A.1.c.). Additionally, EPA would require the implementation of any
needed exposure controls based on initial monitoring and development of
an exposure control plan within 1 year of publication of the final rule
(Unit IV.A.1.d.). EPA believes these timeframes are achievable because
they are consistent with the timeframes in OSHA's 1997 standard for
methylene chloride (62 FR 1494, January 10, 1997). EPA is requesting
comment on these proposed implementation timeframes for the WCPP
requirements.
When considering and developing a WCPP that includes an ECEL, EPA
coordinates and consults with other Federal agencies to achieve the
maximum enforcement of TSCA while avoiding imposing duplicative
requirements, consistent with TSCA section 9(d). For methylene
chloride, EPA's streamlined approach for implementing the ECEL would
seek to align with, to the extent possible, certain elements of the
existing OSHA standard for regulating methylene chloride under 29 CFR
1910.1052. The OSHA PEL, action level, STEL, and ancillary requirements
have established a strong precedent for exposure limit threshold
requirements within the regulated community. However, the existing PEL
and STEL do not eliminate the unreasonable risk identified by EPA under
TSCA, and EPA is therefore proposing to apply new, lower, exposure
thresholds, derived from the TSCA 2020 Risk Evaluation for Methylene
Chloride, while aligning with existing requirements wherever possible
(Refs. 1, 11). For methylene chloride, this approach would eliminate
the unreasonable risk driven 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 proposed requirements include specific exposure limits and
ancillary requirements necessary for the ECEL's successful
implementation as part of a WCPP. Taken together, these WCPP
requirements would apply to the extent necessary so that the
unreasonable risk driven by the conditions of use listed earlier in
this Unit would no longer be presented. EPA's proposal would align with
existing requirements from the OSHA methylene chloride standard at 29
CFR 1910.1052 to the extent possible (also summarized in Unit V.A.). As
discussed in Unit II.B.3., because the unreasonable risk driven by
these occupational conditions of use cannot be addressed entirely
through the continued application of the OSHA standard and associated
requirements, EPA is proposing additional requirements for lower
exposure limits, user notification, recordkeeping, periodic monitoring,
and respirator selection criteria as part of the WCPP. EPA acknowledges
that the values of the ECEL, the ECEL action level, and the EPA STEL,
outlined in Unit IV.A.1.b., may mean that some entities that are
[[Page 28300]]
currently in compliance with the OSHA standard will have to increase
the frequency and scope of their compliance activities in order to
achieve compliance with the requirements being proposed in this action,
such as through the implementation of engineering controls to reduce
exposures to the extent feasible, periodic exposure monitoring
frequency (Unit IV.A.1.c.iii.), establishment of regulated areas (Unit
IV.A.1.d.), use of respiratory protection (Unit IV.A.1.e.ii.), and
notification of monitoring results (Unit IV.A.1.f.ii.).
This Unit includes a summary of the WCPP, including a description
of proposed exposure limits including an ECEL, ECEL action level, and
EPA STEL; proposed 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
requirements proposed for recordkeeping, workplace participation, and
notification in accordance with the hierarchy of controls. This Unit
also describes compliance timeframes for these proposed requirements.
b. Existing Chemical Exposure Limit (ECEL), EPA Action Level (AL), and
Short-Term Exposure Limit (STEL)
To reduce exposures in the workplace and address the inhalation
exposures to methylene chloride for occupational conditions of use that
drive to the unreasonable risk of injury to human health, EPA is
proposing 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, as a matter of risk management
policy, that ensuring exposures remain at or below the ECEL will
eliminate the unreasonable risk of injury to health resulting from
acute and chronic inhalation exposures for certain occupational
conditions of use. EPA's description for how the requirements related
to an ECEL would address the unreasonable risk driven by those
occupational conditions of use and the rationale for the regulatory
approach of a WCPP are in Unit V.A.
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, a potentially
exposed person would be protected against the effects described in Unit
III.B.3., including effects resulting from acute exposure (central
nervous system depression), chronic non-cancer effects (liver
toxicity), and cancer. As an example, the incremental individual cancer
risk at the 8-hour ECEL is 5.1 x 10-6, which is lower than
the occupational benchmark for cancer risk of 1 x 10-4 cited
in the 2020 Risk Evaluation for Methylene Chloride and the NIOSH
Chemical Carcinogen Policy (Ref. 33).
EPA is also proposing to establish an ECEL action level at half of
the 8-hour ECEL, or 1 ppm (4 mg/m\3\) as an 8-hour time-weighted
average. The ECEL action level would be a definitive cut-off point
below which certain compliance activities, such as periodic monitoring,
would not be required as described further in this Unit. As explained
by OSHA, an action level provides employers and employees with
confidence that exposure reduction actions could be taken before
inhalation exposure to methylene chloride exceeds the inhalation
exposure limit (Ref. 34). EPA agrees with this reasoning and, like
OSHA, expects the inclusion of an ECEL action level will stimulate
innovation within industry to reduce exposures to methylene chloride to
levels below the action level (Ref. 34). Therefore, EPA has identified
a need for an action level for methylene chloride and is proposing a
level that would be half the 8-hour ECEL, which is in alignment with
the precedented approach established by OSHA (Ref. 34).
In addition to the 8-hour TWA ECEL, EPA is proposing a STEL of 16
ppm (57 mg/m\3\) as a 15-minute TWA. This short-term exposure limit is
based on the non-cancer endpoint of central nervous system depression
resulting from acute exposures. EPA has also determined, as a matter of
risk management policy, that ensuring exposures remain at or below the
EPA STEL will eliminate the unreasonable risk of injury to health
driven by acute inhalation exposures in an occupational setting. EPA is
proposing the EPA STEL 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
time-weighted average. EPA is also proposing the EPA STEL in
consideration of the severe and potentially irreversible hazards of
such short-term exposures, which, as described in Unit II.B.2., can
range from blurred vision to death.
In summary, EPA is proposing 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 identified as 1 ppm as an
8-hour TWA. EPA is also proposing 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 a 15-
minute TWA, or EPA STEL, of 16 ppm. EPA is proposing 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, thus
eliminating the unreasonable risk of injury to human health driven by
those conditions of use. For the identified conditions of use for which
the concentration thresholds are being proposed, EPA expects that the
regulated community has the ability to detect the values for the ECEL,
ECEL action level, and EPA STEL because these limits are above the
detection limits of methylene chloride 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. 11). EPA's
methodology and inputs for the ECEL and EPA STEL values is directly
derived from the peer reviewed analysis in the 2020 Risk Evaluation for
Methylene Chloride, which was also subject to public comment (Ref 13).
As with all aspects of this rulemaking, the public is welcome to
comment on the methodology for the ECEL and EPA STEL values.
As discussed further in Unit V.A.1., for many of the conditions of
use for which EPA is proposing a WCPP, data was submitted during the
risk evaluation and SBAR process that indicates some facilities may
already be in compliance with the proposed methylene chloride ECEL. As
noted previously in this Unit, EPA expects that, if inhalation
exposures for affected occupational conditions of use are kept at or
below the ECEL and EPA STEL, potentially exposed persons reasonably
likely to be exposed in the workplace would be protected from the
unreasonable risk associated with covered occupational conditions of
use. EPA is also proposing to require owners or operators to comply
with additional requirements that would be needed to ensure successful
implementation of the ECEL and EPA STEL.
c. Monitoring Requirements
i. In General
Monitoring requirements are a key component of implementing EPA's
proposed requirements for a WCPP. Initial monitoring for methylene
chloride is critical for establishing a baseline of exposure for
potentially exposed persons; similarly, periodic exposure monitoring
assures continued
[[Page 28301]]
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 proposes to require that owners or operators determine each
potentially exposed person's exposure by taking a personal breathing
zone air sample of each potentially exposed person's exposure, or by
taking personal breathing zone air samples that are representative of
each potentially exposed person's exposure. Owners or operators would
be permitted to consider personal breathing zone air samples to be
representative of each potentially 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. These requirements align
with the approach taken for characterization of employee exposure in
the 1997 OSHA standard for methylene chloride (see 29 CFR
1910.1052(d)(1)(i) and (ii)). EPA also proposes to require that the
owner or operator ensure, for initial and periodic monitoring, that
their methods and metering results used in performance of the exposure
monitoring 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)). EPA acknowledges that new monitoring methods or
technologies may have been developed since 1997 that would allow for
greater accuracy, and thus a smaller range for monitoring results, and
EPA requests comment on the exposure monitoring accuracy requirements
outlined in this Unit. Therefore, while the EPA requirements utilize
the values of the ECEL, ECEL action level, and EPA STEL, the approach
should be familiar to the regulated community. To ensure compliance for
monitoring activities, EPA proposes recordkeeping requirements outlined
in this Unit. EPA acknowledges that the 25% buffer for the 8-hour and
15-minute TWA potentially could allow some exposures above the exposure
limits proposed here. EPA requests comment on these buffers' effects
and any alternatives to account for measurement variance or
uncertainty.
ii. Initial Exposure Monitoring
Under the proposed regulation, each owner or operator of a facility
engaged in one or more of the conditions of use listed earlier in Unit
IV.A.1.a. would be required to perform initial exposure monitoring 180
days after publication of the final rule to determine the extent of
exposure of potentially exposed persons to methylene chloride. Initial
monitoring would 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 monitoring sample would be
required to be taken when and where the operating conditions are best
representative of each potentially exposed person's full-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 include
persons closest to the source of methylene chloride, so that the
monitoring results would be representative of the most highly exposed
persons in the workplace. Additionally, analogous to the OSHA standard,
EPA expects that owners and operators would conduct initial exposure
monitoring representative of all tasks a potentially exposed person
would be expected to do. EPA understands that certain tasks may occur
less frequently or may reflect upset conditions (for example, due to
malfunction). EPA is soliciting comments regarding how owners and
operators could conduct initial exposure monitoring to ensure that it
is representative of all tasks likely to be conducted by potentially
exposed persons.
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 re-establish a monitoring
baseline. Aligning with the existing OSHA standard (29 CFR
1910.1052(d)(2)) to the extent possible, EPA is proposing 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 5 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. The oldest objective data used to demonstrate that
exposures are below the ECEL action level and EPA STEL will indicate
the beginning of the 5-year cycles of recurring initial exposure
monitoring as described in this Unit;
(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, unlike the OSHA
standards in 29 CFR 1910.1052(d)(2) to (d)(3), the owner or operator
must conduct an initial monitoring at least once every 5 years since
its last monitoring. This new initial monitoring would have to 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
[[Page 28302]]
commence one or more conditions of use listed in Unit IV.A.1.a. after
the effective date of the rule, the owner or operator would be required
to perform initial exposure monitoring within 180 days and would be
required to, at a minimum, conduct initial exposure monitoring every 5
years thereafter if methylene chloride is present in the facility. EPA
is soliciting comments regarding the proposed requirement for recurring
5-year initial exposure monitoring.
iii. Periodic Exposure Monitoring
EPA's proposal 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 proposing the
following periodic monitoring for owners or operators. These proposed
requirements are also outlined in Table 1.
If all samples taken during the initial exposure
monitoring reveal: a concentration 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 not be required, except
when additional exposure monitoring (Unit IV.A.1.c.v.) 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 not be required
except when additional monitoring (Unit IV.A.1.c.v.) measurements
require it, but EPA STEL periodic monitoring would be required every 3
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 would be required to be monitored every 6 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 would be required
to be monitored every 6 months and EPA STEL would be required to be
monitored every 3 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 would be required to be
monitored every 3 months.
The owner or operator would be permitted to alter the
periodic exposure monitoring frequency from every 3 months to every 6
months if two consecutive monitoring events taken at least 7 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 periodic exposure monitoring frequency of every 6 months to an
initial exposure monitoring frequency of once every 5 years if two
consecutive monitoring events taken at least 7 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 5-year initial exposure
monitoring must occur.
In addition to the periodic monitoring standards described earlier,
EPA is proposing 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 3-month
interval but does not engage in any of the conditions of use listed in
Unit IV.A.1.a. for which the WCPP is proposed over the entirety of
those 3 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.A.1.a. for which the WCPP is
proposed.
Based on its monitoring results, if the owner or operator
would be required to monitor the ECEL in a 6-month interval but does
not engage in any of the conditions of use listed in Unit IV.A.1.a. for
which the WCPP is proposed over the entirety of those 6 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.A.1.a. for which the WCPP is
proposed.
Initial monitoring would be required to occur at least
once every 5 years if methylene chloride is present. EPA requests
comment on the timeframes for periodic monitoring outlined in this
Unit, particularly whether more frequent monitoring may be possible or
recommended.
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 not required.
level and at or below the EPA STEL.
If the initial exposure monitoring ECEL monitoring not required
concentration is below the ECEL action and EPA STEL monitoring
level and above the EPA STEL. required every 3 months.
If the initial exposure monitoring ECEL monitoring every 6 months.
concentration is at or above the ECEL
action level and at or below the ECEL;
and at or below the EPA STEL.
If the initial exposure monitoring ECEL monitoring every 6 months
concentration is at or above the ECEL and EPA STEL monitoring every
action level and at or below the ECEL; 3 months.
and above the EPA STEL.
If the initial exposure monitoring ECEL monitoring every 3 months
concentration is above the ECEL and and EPA STEL monitoring every
below, at, or above the EPA STEL. 3 months.
Two consecutive monitoring events have Reduce periodic monitoring
taken place 7 days apart that indicate frequency from every 3 months
that potential exposure has decreased to every 6 months.
from above the ECEL to at or below the
ECEL, but at or above the ECEL action
level.
Two consecutive monitoring events have Transition from periodic
taken place 7 days apart that indicate monitoring frequency of every
that potential exposure has decreased 6 months to initial monitoring
to below the ECEL action level and at once every 5 years. The second
or below the EPA STEL. consecutive monitoring event
will delineate the new date
from which the next 5-year
initial exposure monitoring
must occur.
[[Page 28303]]
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 proposed 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 proposed.
Owner or operator engages in any of the The owner or operator may forgo
conditions of use for which WCPP is the upcoming periodic
proposed and is required to monitor monitoring event. However,
the ECEL in a 6-month interval, but documentation of cessation of
does not engage in any of those manufacture, processing, use,
conditions of use for the entirety of or disposal of methylene
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 proposed.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
discussed in Unit IV.A.1.c.v.
iv. Minimum Frequency of Exposure Monitoring
EPA is proposing to require that an initial monitoring event be
conducted at a minimum frequency of every 5 years by owners or
operators using methylene chloride for any condition of use subject to
the WCPP. This in contrast to OSHA's standards in 1910.1052(d)(2) to
(d)(3) whereby employers would otherwise be permitted to discontinue
monitoring indefinitely based on monitoring results. Moreover, EPA is
proposing that monitoring requirements could only be made less frequent
based on the results of the initial exposure monitoring or the periodic
exposure monitoring outlined under Unit IV.A.1.c.iii.
OSHA's standards in 1910.1052(d)(2)(i) through (iii) allow for a
discontinuation of initial monitoring which subsequently precludes the
need for periodic monitoring unless additional monitoring is required
under certain conditions. Given the steep dose response for methylene
chloride that may lead up to and include fatalities as a result of
inhalation exposure, EPA is instead proposing to require that a minimum
initial monitoring frequency be established at 5-year intervals. EPA is
requesting public comments on the proposed conditions for periodic
monitoring for methylene chloride as part of implementation of the WCPP
that differ from OSHA's existing monitoring requirements under 29 CFR
1910.1052.
v. Additional Exposure Monitoring
In addition to initial and periodic monitoring, there are some
additional circumstances that would require a new initial exposure
monitoring. EPA is proposing that the owner or operator complying with
the WCPP would carry out this additional exposure monitoring (analogous
to those requirements outlined in 29 CFR 1910.1052(d)(4)) 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.
d. Exposure Control Plan (ECP)
EPA recommends and encourages the use of pollution prevention as a
means of controlling exposures whenever practicable. Pollution
prevention, also known as source reduction, is any practice that
reduces, eliminates, or prevents pollution at its source (e.g.,
elimination and substitution, as described in the hierarchy of
controls). While the WCPP is intended to be non-prescriptive to allow
more flexibility to regulated entities than requiring specific
prescriptive controls, EPA is proposing to require the use of
elimination and substitution, followed by the use of engineering
controls, administrative controls, and work practices prior to
requiring the use of respirators as a means of controlling inhalation
exposures below EPA's ECEL or STEL, in accordance with the hierarchy of
controls. If an owner or operator chooses to replace methylene chloride
with a substitute, EPA recommends that they carefully review the
available hazard and exposure information on the potential substitutes
to avoid a substitute chemical that might later be found to present
unreasonable risks or be subject to regulation (sometimes referred to
as a ``regrettable substitution''). EPA expects that, for conditions of
use for which EPA is proposing a WCPP, compliance at most workplaces
would be part of an established industrial hygiene program that aligns
with the hierarchy of controls. Workplaces that cannot, in accordance
with that hierarchy, eliminate the source of methylene chloride
emissions or replace methylene chloride with a substitute would be
required to use feasible engineering controls, and subsequently
feasible administrative controls, to implement process changes to
reduce exposures following the hierarchy of controls (Ref. 9). EPA also
expects those owners or operators already implementing the OSHA PEL of
25 ppm as an 8-hour TWA would revise their monitoring program to follow
EPA's ECEL requirements with EPA's lower ECEL of 2 ppm as an 8-hour TWA
and EPA's STEL of 16 ppm as a 15-minute TWA.
Analogous to the OSHA Standard (29 CFR 1910.1052(e)), EPA is
proposing to require 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. This regulated area would
be demarcated using administrative controls, e.g., highly visible
signifiers, in multiple languages as appropriate, placed in conspicuous
areas, and documented through training and recordkeeping. The owner or
operator would be required to restrict access to the regulated area
from any potentially exposed person that lacks proper training or is
otherwise unauthorized to enter.
EPA proposes to require regulated entities use the hierarchy of
controls to the extent feasible and supplement
[[Page 28304]]
further protections using PPE, 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 proposes to require the owner or operator to use
feasible controls (including elimination, substitution, engineering
controls, or administrative controls and work practices) to reduce
methylene chloride concentrations in the workplace to the lowest levels
achievable and, analogous to the requirements under 29 CFR
1910.1052(e)(3), 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 would require 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.
EPA also proposes to require that the owner or operator document
their efforts to use elimination, substitution, engineering controls,
and administrative controls to reduce exposure to or below the ECEL or
EPA STEL in an exposure control plan. In addition, analogous to the
requirements under 29 CFR 1910.1052(f)(2), an owner or operator would
be prohibited from rotating work schedules to comply with the ECEL 8-
hour TWA.
EPA proposes to require 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:
(i) Identification 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;
(ii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(iii) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training, or other steps
taken;
(iv) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
using them accordingly;
(v) Occurrence and duration of any start-up, shutdown, or
malfunction of exposure controls or of facility equipment that causes
air concentrations above the ECEL or EPA STEL and subsequent corrective
actions taken during start-up, shutdown, or malfunctions to mitigate
exposures to methylene chloride; and
(vi) Objective data generated during the previous 5 years, when
used to forgo the initial exposure monitoring, must include: the use of
methylene chloride being evaluated, the source of objective data,
measurement methods, measurement results, and measurement analysis of
the use of methylene chloride, and any other relevant data to the
operations, processes, or person's exposure.
e. 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 proposes to set 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 proposing to require 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 proposing that
the owner or operator comply with 29 CFR 1910.134 for proper use,
maintenance, fit-testing, and training of respirators. EPA recognizes
that there may be limitations in using certain types of PPE or
respirator protection for various work scenarios such as cost, time
burdens, ergonomic and dexterity considerations, climate, size, and
capability.
i. Required Dermal Protection
EPA is proposing to require 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 proposing to require owners and operators
to continue to 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. 35) and in appendix F of the 2020 Risk
Evaluation for Methylene Chloride (Ref. 1). EPA requests comment on the
degree to which additional guidance related to use of gloves might be
necessary. Additionally, EPA requests comment on whether EPA should
specifically incorporate dermal protection into the exposure control
plan and require consideration of the hierarchy of controls for dermal
exposures.
ii. Required Respiratory Protection
EPA is proposing 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 (16ppm); see also the following table (Table 2).
These requirements would 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 proposing to establish 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. While this Unit includes respirator selection requirements for
respirators of Assigned Protection Factor (APF) of 1,000 or greater,
EPA does not anticipate that respirators beyond APF 25 will be widely
or regularly used to address unreasonable risk, particularly when other
controls are put in place. EPA anticipates that owners or operators
would attempt to minimize respirator costs by reducing inhalation
exposures levels so that, if a respirator is needed, a supplied-air
respirator could be used in lieu of a self-contained breathing
apparatus. Under this proposed regulatory option, as with existing OSHA
regulations, air-purifying respirators (in contrast to air-supplied
[[Page 28305]]
respirators) would not be permitted as a means of mitigating methylene
chloride exposure, as they do not provide adequate respiratory
protection against this chemical (Ref. 36). Additionally, EPA
acknowledges in Unit V.A.1. 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).
If the measured exposure concentration is at or below the
ECEL (2 ppm 8-hour TWA) and EPA STEL (16 ppm 15-minute TWA): no
respiratory protection would be required.
If the measured exposure concentration is above 2 ppm and
less than or equal to 50 ppm (25 times the ECEL): the respirator
protection required would be any NIOSH-certified supplied-air
respirator (SAR) or airline respirator in a continuous-flow mode
equipped with a loose-fitting facepiece or helmet/hood (APF 25).
If the measured exposure concentration is above 50 ppm and
less than or equal to 100 ppm (50 times the ECEL): the respirator
protection required would be: (i) Any NIOSH-certified Supplied-Air
Respirator (SAR) or airline respirator in a demand mode equipped with a
full facepiece (APF 50); or (ii) Any NIOSH-certified Self-Contained
Breathing Apparatus (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
respirator protection required would be: (i) Any NIOSH-certified
Supplied-Air 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-certified Supplied-Air Respirator (SAR) or
Airline Respirator in pressure-demand or other positive-pressure mode
equipped with a full facepiece (APF 1,000); or (iii) Any NIOSH-
certified Self-Contained Breathing Apparatus (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 Any NIOSH-certified supplied-air
or equal to 50 ppm (25 times the respirator (SAR) or airline
ECEL). respirator in a continuous-flow
mode equipped with a loose-fitting
facepiece or helmet/hood (APF 25).
Above 50 ppm and less than or Either (i) any NIOSH-certified
equal to 100 ppm (50 times the Supplied-Air Respirator (SAR) or
ECEL). airline respirator in a demand mode
equipped with a full facepiece (APF
50); or (ii) any NIOSH-certified
Self-Contained Breathing Apparatus
(SCBA) in demand-mode equipped with
a full facepiece or helmet/hood
(APF 50).
Unknown concentration or at any One of (i) any NIOSH-certified
value above 100 ppm and up to Supplied-Air Respirator (SAR) or
2,000 ppm (1,000 times the ECEL). Airline Respirator in a continuous-
flow mode equipped with a full
facepiece or certified helmet/hood
(APF 1,000); or (ii) any NIOSH-
certified Supplied-Air Respirator
(SAR) or Airline Respirator in
pressure-demand or other positive-
pressure mode equipped with a full
facepiece (APF 1,000); or (iii) any
NIOSH-certified 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).
------------------------------------------------------------------------
f. Additional Proposed Requirements
i. Workplace Participation
EPA encourages owners and operators to consult with potentially
exposed persons on the development and implementation of exposure
control plans and PPE/respirator programs. EPA is proposing to require
owners and operators to 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 in workplace participation, EPA is proposing that the
owner or operator document the notice to and ability of any potentially
exposed person that may reasonably be affected by 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.
ii. Notification of Monitoring Results
EPA proposes that when a potentially exposed person's exposure to
methylene chloride exceeds the ECEL action level within a regulated
area, the owner or operator would 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,
analogous to those requirements outlined in 29 CFR 1910.1052(l). EPA
proposes 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 (as described in Unit
IV.A.1.d.). 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. 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 refer to a document
available to the potentially exposed persons which states the actions
to be taken to reduce exposures, and to 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). While 15 working days is
consistent with requirements under the OSHA methylene chloride
standard, EPA notes that it may be preferable to require more expedient
notification of monitoring results, and that precedent exists in some
circumstances for faster
[[Page 28306]]
notification timeframes (e.g., OSHA requirements for the construction
sector require a 5-day timeframe). EPA therefore requests comment on
the 15-day timeframe for notification of potentially exposed persons of
monitoring results and the possibility for a shorter timeframe, such as
5 days.
iii. Recordkeeping
For each monitoring event of methylene chloride, OSHA requires
under 29 CFR 1910.1052(m) that the employer record 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 exposed employees' names, work shifts, and job
classifications; and exposure of all the employees represented by
monitoring, indicating which potentially exposed persons were actually
monitored. EPA is requiring that this information is kept by the owner
or operator of record for potentially exposed persons. In addition to
the requirements outlined in 29 CFR 1910.1052(m)(2), EPA is proposing
to require 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 (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
monitoring 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. 11) 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.A.1.c.ii.,
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 proposed in this Unit;
(iv) Compliance with the Good Laboratory Practice Standards at 40
CFR part 792;
(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 proposing that owners and operators must retain
compliance records for 5 years, unless a longer retention time is
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
section (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.
All records required to be maintained by this Unit could be kept in
the most administratively convenient form (electronic or paper). The
owner or operator would be required to document training or re-training
(analogous to 29 CFR 1910.1052(l)(5)) 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. EPA expects that the content of
such training will not exceed what is already required by 29 CFR
1910.1052 section (l) and appendix A. In addition, the owner or
operator would be 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.
g. Compliance Timeframes
With regard to the compliance timeframe for those occupational
conditions of use which are subject to the WCPP, EPA is proposing to
require that owners and operators establish initial exposure monitoring
according to the process outlined in this Unit by [DATE 180 DAYS AFTER
DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]. EPA is
proposing to require 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 by [DATE 270 DAYS AFTER DATE
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], and 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 3
months after receipt of the results of any exposure monitoring or
within 9 months after the date of publication of the final rule in the
Federal Register (for any new facilities, or a facility commencing one
or more conditions of use listed in Unit IV.A.1.a. after the effective
date of the final rule, the timeframe for the requirement for initial
exposure monitoring is described earlier in Unit IV.A.1.c.ii.;
following that, the requirements and timeframes in this Unit would
apply). EPA is also proposing to require owners and operators demarcate
a regulated area within 3 months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL or EPA STEL.
Owners and operators should proceed accordingly to implement an
exposure control plan by [DATE 360 DAYS AFTER DATE OF PUBLICATION OF
FINAL RULE IN THE FEDERAL REGISTER]. EPA requests comment relative to
the ability of owners or operators to conduct initial monitoring by
[DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER], and anticipated timelines for any procedural adjustments
needed to comply with the requirements outlined in this Unit. EPA may
finalize shorter or longer compliance timeframes based on public
comment.
2. Prohibition of Certain Industrial and Commercial Uses
Except for those uses which will continue under the WCPP, EPA is
proposing to prohibit industrial and commercial use of methylene
chloride, including use of methylene chloride in: solvent for batch
vapor degreasing; solvent for in-line vapor degreasing; solvent for
cold cleaning; solvent for aerosol spray degreaser/cleaner; adhesives,
sealants, and caulks; paints and coatings; paint and coating removers
(including furniture refinishers); adhesive and caulk removers; metal
aerosol degreasers; metal non-aerosol degreasers; finishing products
for fabric, textiles and leather; automotive care products (functional
fluids for air conditioners); automotive care products (interior car
care); automotive care products (degreasers); apparel and footwear care
products; spot removers for apparel and textiles; liquid lubricants and
greases; spray lubricants and greases; aerosol
[[Page 28307]]
degreasers and cleaners; non-aerosol degreasers and cleaners; cold pipe
insulations; solvent that becomes part of a formulation or mixture;
processing aid; propellant and blowing agent; electrical equipment,
appliance, and component manufacturing; plastic and rubber products
manufacturing; cellulose triacetate film production; anti-spatter
welding aerosol; oil and gas drilling, extraction, and support
activities; toys, playground and sporting equipment; carbon remover,
wood floor cleaner, and brush cleaner; and lithographic printing plate
cleaner. This does not include manufacturing and processing of
methylene chloride for commercial use or industrial and commercial use
of methylene chloride as a laboratory chemical, for which EPA is
proposing to require compliance with a WCPP for the reasons described
in Unit III.B.3. This rationale is discussed further in Unit V.A.1.
As Discussed in Unit III.B.1.f., the restrictions in this proposed
rule do not apply to any substance that is excluded from the definition
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi).
However, EPA requests comment on the impacts, if any, the proposed
prohibition described in this Unit, or other aspects of this proposal,
may have on the production and availability of any food, food additive,
drug, cosmetic, device, or other substance excluded from the definition
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi).
As discussed in Unit III.B.3., based on consideration of
alternatives, the broad range of work environments and activities, and
the severity of the hazards of methylene chloride, EPA determined that
prohibition is the best way to address the unreasonable risk from
methylene chloride driven by the conditions of use identified in this
Unit. EPA requests comment regarding the number of entities that could
potentially close as well as associated costs with a prohibition of
methylene chloride for certain industrial and commercial conditions of
use identified in this Unit. EPA would also like comment on whether it
should consider a de minimis level of methylene chloride in
formulations for certain continuing industrial and commercial uses to
account for impurities (e.g., 0.1% or 0.5%) when finalizing the
prohibitions described in this Unit, and, if so, what level should be
considered de minimis.
EPA is proposing that the prohibition for uses described in this
section 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). This proposal includes
restrictions 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. When
proposing these compliance dates, EPA considered sustained awareness of
risks, including acute fatalities, resulting from methylene chloride
exposure as well as precedent established by the OSHA standards (62 FR
1494, January 10, 1997). EPA has no information indicating that the
proposed compliance dates are not practicable for the activities that
would be prohibited, or that additional time is needed for products
affected by the proposed restrictions to clear the channels of trade.
However, EPA requests comment on whether additional time is needed, for
example, for products affected by proposed restrictions to clear the
channels of trade. EPA may finalize shorter or longer compliance
timeframes based on public comment.
Additionally, EPA recognizes that there may be instances where an
ongoing use of methylene chloride that has implications for national
security or critical infrastructure as it relates to other Federal
agencies (e.g., DOD, NASA) is identified after the methylene chloride
rule is finalized, but the final rule prohibits that use. For instances
like that, EPA requests comments on an appropriate, predictable process
that could expedite reconsideration for uses that Federal agencies or
their contractors become aware of after the final rule is issued using
the tools available under TSCA, aligning with the requirements of TSCA
section 6(g). One example of an approach could be the establishment by
rulemaking of a Federal agency category of use that would require
implementation of the WCPP and periodic reporting to EPA on details of
the use as well as progress in discontinuing the use or finding a
suitable alternative. To utilize the category of use a Federal agency
would petition EPA, supported by documentation describing the specific
use (including documentation of the specific need, service life of any
relevant equipment, and specific identification of any applicable
regulatory requirements or certifications, as well as the location and
quantity of the chemical being used); the implications of cessation of
this use for national security or critical infrastructure (including
how the specific use would prevent injuries/fatalities or otherwise
provide life-supporting functions); exposure control plan; and, for
Federal agency uses where similar adoption by the commercial sector may
be likely, concrete steps taken to identify, test, and qualify
substitutes for the uses (including details on the substitutes tested
and the specific certifications that would require updating; and
estimates of the time required to identify, test, and qualify
substitutes with supporting documentation). EPA requests comment on
whether these are the appropriate types of information for use in
evaluating this type of category of use, and whether there are other
considerations that should apply. EPA would make a decision on the
petition within 30 days and publish the decision in the Federal
Register shortly after. Additionally, during the year following the
petition, EPA would take public comment on the approved petition and no
later than 180 days after submitting the petition to EPA, the
requesting agency would submit monitoring data indicating compliance
with the WCPP at each relevant location as well as documentation of
efforts to identify or qualify substitutes. In the absence of that
confirmatory data, the utilization of the generic Federal agency
category of use would expire within one year of the date of receipt by
EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking
for those instances where the Federal agency could not demonstrate
compliance with the WCPP. This is just one example of a potential
process. EPA requests comments on a process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued.
3. Prohibition of Manufacturing, Processing, and Distribution of
Methylene Chloride for Consumer Use
In the 2020 Risk Evaluation for Methylene Chloride, EPA evaluated
consumer use of methylene chloride: as a solvent in aerosol spray
degreasers/cleaners; in adhesives and sealants in single component
glues and adhesives and sealants in caulks; in paints and coatings in
brush cleaners and in adhesive/caulk removers; in metal products in
aerosol and non-aerosol degreasers and cleaners; in automotive care
products in functional fluids for air conditioners and in degreasers;
in lubricants and greases in liquid and spray lubricants and greasers
and in aerosol and non-aerosol degreasers and cleaners; in building and
construction
[[Page 28308]]
materials in cold pipe insulation; in arts, crafts, and hobby materials
in crafting glue and cement/concrete; and in other uses such as anti-
spatter welding aerosol and in carbon remover and brush cleaner. All
consumer uses evaluated in the 2020 Risk Evaluation for Methylene
Chloride drive unreasonable risk of injury to health. As such, for
purposes of this risk management rulemaking, ``consumer use'' refers to
all known, intended, or reasonably foreseen methylene chloride consumer
uses. EPA is proposing to prohibit the manufacturing, processing, and
distribution in commerce of methylene chloride for all consumer use.
(The proposed prohibitions would not extend to the use of methylene
chloride in consumer paint and coating removers since that use was not
evaluated in the 2020 Risk Evaluation for Methylene Chloride and
manufacturing, processing, and distribution for that use are already
prohibited. (84 FR 11420 (March 27, 2019)).
As discussed in Unit III.B.3., based on consideration of the
severity of the hazards of methylene chloride in conjunction with the
limited options available to adequately address the identified
unreasonable risk to consumers and bystanders under TSCA section 6(a),
EPA is proposing to address the unreasonable risk from consumer use by
prohibiting the manufacturing (including import), processing, and
distribution in commerce of methylene chloride for consumer use in
order to remove methylene chloride and products containing methylene
chloride from the market, thereby effectively eliminating instances of
consumer use.
Additionally, EPA is proposing to prohibit 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 outlined in Unit IV.A.1.
from being purchased by consumers. A retailer is any person or business
entity that distributes or makes available products to consumers,
including through e-commerce internet sales or distribution. If a
person or business entity distributes or makes available any product to
at least one consumer, then it is considered a retailer (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 would prevent retailers from making these
products available to consumers, which would help address that part of
the unreasonable risk driven by consumer use of methylene chloride
(Ref. 37). EPA promulgated a similar prohibition for retailers in the
2019 final rule addressing unreasonable risk from consumer use of
methylene chloride in Paint and Coating Removal (84 FR 11420, March 27,
2019), and has not received negative feedback from retailers regarding
sales losses. EPA has continued to receive feedback from stakeholders,
including small businesses, on particular strategies they suggest could
be used to ensure that distribution only occurs to commercial entities,
such as requiring a business number (Ref. 6). To that end, EPA would
like comment on whether distributors that are not retailers should be
required to use tax IDs or other verification methods prior to selling
methylene chloride or products containing methylene chloride to ensure
consumers are not purchasing methylene chloride or industrial or
commercial products containing methylene chloride.
Additionally, during litigation on the 2019 final rule petitioners
argued that EPA's definition of ``retailer'' was so broad as to cover
all commercial entities, creating supply chain issues for commercial
users seeking to attain and use the chemical for commercial activities
(Lab. Council for Latin Am. Advancement v. United States Env't Prot.
Agency, 12 F.4th 234 (2d Cir. 2021)). EPA has not found this to be the
case; small businesses that are non-retail distributors exist and even
participated as small entity representatives consulted as part of the
SBAR process for this rulemaking. Nonetheless, EPA is soliciting
comment on whether similar supply chain issues for uses that are
permitted under the WCPP are anticipated.
EPA is proposing that the prohibitions of manufacturing,
processing, and distribution in commerce of methylene chloride for
consumer use described in this section 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. EPA
considered irreversible health effects and risks, such as acute
fatalities, associated with methylene chloride when proposing
compliance dates. EPA has no information indicating these compliance
dates are not practicable for the activities that would be prohibited,
or that additional time is needed for products affected by proposed
restrictions to clear the channels of trade. However, EPA requests
comment on whether additional time is needed, for example, for products
affected by proposed restrictions to clear the channels of trade. EPA
may finalize shorter or longer compliance timeframes based on public
comment. EPA would also like comment on whether it should consider a de
minimis level of methylene chloride in formulations for certain
continuing industrial and commercial uses to account for impurities
(e.g., 0.1% or 0.5%) when finalizing these prohibitions, and, if so,
what level should be considered de minimis.
4. Other Requirements
a. Recordkeeping
For conditions of use that are not otherwise prohibited under this
proposed regulation, EPA is also proposing 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 proposed regulation; and that
they maintain such records for a period of 5 years from the date the
record is generated. EPA notes that this 5-year record retention period
is an increase from the 3-year requirements for records related to
consumer paint and coating removal finalized in the 2019 final rule.
However, the 3-year requirement still applies to records generated
under that rule. EPA is proposing that this requirement begin at the
effective date of the rule (60 days following publication of the final
rule in the Federal Register). Recordkeeping requirements would ensure
that owners or operators can demonstrate compliance with the proposed
regulations if necessary. Note that this requirement would expand those
recordkeeping requirements promulgated in 2019 at 40 CFR 751.109
affecting manufacturers, processors, and distributors of methylene
chloride.
b. Downstream Notification
For conditions of use that are not otherwise prohibited under this
proposed regulation, EPA is proposing that manufacturers (including
importers), processors, and distributors, excluding retailers, of
methylene chloride and methylene chloride-containing products provide
downstream notification of certain prohibitions through Safety Data
Sheets
[[Page 28309]]
(SDSs) by adding to sections 1(c) and 15 of the SDS the following
language:
After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], this chemical/product cannot be distributed
in commerce to retailers. After [DATE 360 DAYS AFTER DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], this chemical/
product is and can only be distributed in commerce or processed 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 acrylic and
polycarbonate in mission-critical military and space applications,
including in the production of specialty batteries for such
applications that is performed by the Department of Defense, the
Department of Homeland Security, or the National Aeronautics and
Space Administration or their contractors at locations controlled by
the agency or the agency's contractor; (7) Industrial or commercial
use for paint and coating removal from safety-critical, corrosion-
sensitive components of aircraft and spacecraft that are owned or
operated by the U.S. Department of Defense, the National Aeronautics
and Space Administration, the U.S. Department of Homeland Security,
and the Federal Aviation Administration that is performed by the
agency or agency contractors at locations controlled by the agency
or the agency's contractor; (8) Industrial or commercial use for
paint and coating removal from safety-critical, corrosion-sensitive
components of other aircraft and spacecraft until [10 years after
date of publication of the final rule in the Federal Register], and
(9) Disposal.
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on methylene chloride
under TSCA as well as 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 751.111(a). As they
become effective, the new amended requirements would supersede those
notification requirements promulgated in 2019.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA is proposing
a 150-day period for manufacturers and a 210-day period for processors
and distributors to implement the proposed SDS changes (following
publication of the final rule).
EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this Unit.
5. TSCA Section 6(g) Exemptions
Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture. TSCA section 6(g)(1)(B) permits
such an exemption if EPA finds that compliance with the requirement, as
applied with respect to the specific condition of use, would
significantly disrupt the national economy, national security, or
critical infrastructure.
TSCA section 6(g)(2) requires EPA to analyze the need for the
exemption, and to make public the analysis and a statement describing
how the analysis was taken into account when proposing an exemption
under TSCA section 6(g). To that end, based on discussions and
information provided by industry stakeholders, EPA has analyzed the
need for different exemptions and is proposing to grant two of them,
with conditions as required under TSCA section 6(g)(4) and described in
Units IV.A.5.a.ii. and IV.A.5.b.ii. This Unit presents the results of
that analysis.
a. Uses of Methylene Chloride for Paint and Coating Removal Essential
for Critical Infrastructure
i. Analysis of the Need for TSCA Section 6(g)(1)(B) Exemption for
Commercial Aviation and Aerospace
EPA has preliminarily determined that a prohibition on the
commercial use of methylene chloride for paint and coating removal from
safety-critical, corrosion-sensitive components of aircraft and
aerospace vehicles for commercial aviation and aerospace would
significantly disrupt the national economy and critical infrastructure.
Aviation has been designated by co-sector agencies DHS and DOT as a key
subsector in the Transportation Systems Sector, one of 16 designated
critical infrastructure sectors. There are no technically feasible
alternatives currently available for methylene chloride used in paint
and coating removal for safety-critical, corrosion-sensitive components
of aircraft and aerospace vehicles. Thus, commercial aviation and
aerospace compliance with the proposed ban on methylene chloride use in
commercial paint and coating removal would significantly disrupt
critical infrastructure.
As explained by a commenter on the 2017 Notice of Proposed
Rulemaking (NPRM), all aircraft have similar safety-critical,
corrosion-sensitive components of the type described by DOD (Ref. 38).
For example, commercial aircraft often contain components, such as
landing gear, that are made from high-strength alloy steels. According
to this commenter, the aerospace industry, like DOD, has made
significant investments in the evaluation of alternative methods and
materials for removing coatings. The commenter states that the industry
has had some success, depending upon the substrate, surface treatment,
and coating system, but investigation continues into both chemical and
non-chemical means. Non-chemical methods, such as plastic beads, were
not suitable in all instances due to concerns about damaging the
substrate. Many alternative chemical strippers were not effective on
all coatings, which caused corrosion concerns in some cases. According
to this commenter, benzyl alcohol is a qualified alternative paint
remover for some paint formulations but cannot be considered a ``drop-
in'' replacement for all applications due to performance concerns.
The concerns expressed by this commenter about corrosion-sensitive
components on aircraft and aerospace equipment echo the concerns over
methylene chloride alternatives expressed by DOD and discussed at
length in the preamble to EPA's 2017 proposal. For example, both the
commenter and DOD stated that currently available substitute chemicals
cannot completely remove certain coatings (Ref. 38). This results in
improperly applied, incompletely adhering replacement coatings, which
may result in corrosion of underlying critical parts. For another
example, according to the commenter and DOD, substitute chemicals are
also incompatible with some underlying metallic, nonmetallic, and
composite materials, resulting in material damage to critical
components, and the potential for an increased risk of catastrophic
failure of safety critical parts. The commenter on the 2017 NPRM also
stated that the process for evaluating and then adopting alternatives
in aviation applications is a multi-year process. According to the
commenter, the materials required to remove coatings on aircraft parts
must be developed by a material formulator to meet technical
performance requirements and must be ``qualified by the Original
Equipment Manufacturer (OEM), and then shown to not cause harm to the
aircraft or negatively affect performance to the FAA prior to
implementation'' (Ref. 38). The commenter stated that this can take
years, with no guarantee of success, so
[[Page 28310]]
a longer timeframe for aviation and aerospace to make the transition is
appropriate. The commenter suggested that 10 years would be a realistic
estimate of the time needed.
More recently, Boeing provided information to EPA indicating that
the company has invested considerable resources over many years to
qualify and implement alternatives to methylene chloride, including a
combination of acid, alkaline, and hydrogen peroxide-activated benzyl
alcohol removers and plastic media blast (Ref. 31). Boeing continues to
evaluate potential alternatives, such as laser ablation, which the
company believes will, if implemented, eliminate hazardous waste,
address ergonomic challenges and save significant time over traditional
paint and coating removal operations. According to Boeing, the company
has identified several paint and coating removal applications with no
feasible alternatives to methylene chloride (Ref. 31). These include:
Large parts or parts with complex geometries that cannot
undergo media blasting or strip tank immersion either due to size
constraints or entrapment concerns, and where hand abrasion is
impractical;
Situations in which selective coating removal is needed,
e.g., the preservation of a conversion coating;
Effective removal of oven-cured paints and coatings;
Localized removal of coatings on overhaul or rework parts
to reveal part markings and serial numbers;
Stripping of parts preceding non-destructive testing,
where other coating removal methods such as media blasting could hide
defects; and
Removal of polyvinyl formal or polyurethane insulating
enamel from copper magnet wire.
While there are alternatives available for many applications, the
public comments on the 2017 NPRM, and the information provided by
Boeing in 2022 demonstrate there are several aviation and aerospace
applications for which there are limited alternatives to methylene
chloride for paint and coating removal, due to concerns about damage to
the substrate, and these limited alternatives take longer to work. EPA
has preliminarily determined that lengthening the time that commercial
aircraft and spacecraft are out of service due to necessary safety
inspections and repairs will have a considerable adverse impact on air
travel and other infrastructure elements such as satellite placement.
Therefore, EPA has preliminarily determined that requiring commercial
aviation and aerospace sectors to comply at this time with the ban on
methylene chloride use in paint and coating removal would cause
significant disruption to critical infrastructure. In addition, EPA has
preliminarily determined that compliance at this time with the proposed
ban on the manufacture, processing, and distribution in commerce of
methylene chloride for commercial paint and coating removal for these
specific commercial aviation and aerospace uses would also result in a
significant disruption to critical infrastructure. EPA's proposed
conditions for this exemption are described in this Unit, including
proposed requirements to comply with the WCPP.
EPA acknowledges that in many cases commercial aviation facilities
may be more sophisticated and industrialized than other commercial
paint and coating removal operations. However, at the time of proposal,
data available to EPA demonstrate that the risks from paint and coating
removal in the aviation sector do not differ significantly from other
commercial paint and coating removal (Ref. 1). As shown in the 2020
Risk Evaluation for Methylene Chloride, high-end and central tendency
estimates for aircraft paint stripping are three orders of magnitude
below the benchmark for acute inhalation risks and four orders of
magnitude below the benchmark for chronic non-cancer inhalation risks
(Ref. 1). Even if use of APF 50 air supplied respirators were assumed,
the risks that remain for both high-end and central tendency would be
an order of magnitude below the benchmark for both endpoints (Ref. 1).
Therefore, while EPA expects that some of these facilities could
successfully follow the requirements of the WCPP, based on qualitative
information provided by stakeholders, this expectation is not
sufficiently supported by monitoring data in the 2020 Risk Evaluation
for Methylene Chloride. As a result, there is significant uncertainty
whether the requirements of the WCPP could be implemented successfully
in this sector for this particular use on a consistent and reliable
basis, in part due to the diversity of facilities in this sector. EPA
understands that generally large commercial aviation facilities could
have industrial hygiene expertise, sophisticated engineering and
administrative controls, and experience with rigorous safety
requirements and methods for ensuring continuous strong safety records
(Ref. 31). However, EPA is concerned about the ability of smaller
aircraft repair shops to implement the WCPP over the long term,
particularly for this condition of use. While EPA recognizes that the
proposed TSCA section 6(g) exemption for commercial aircraft paint and
coating removal could also cover these smaller aircraft repair shops,
the exemption is time-limited and ultimately would result in these
small shops using alternatives to methylene chloride. While Federal
agencies and contractors should be regulated under the WCPP, the Agency
is proposing that commercial use of methylene chloride for a similar
type of paint and coating removal be regulated with a time-limited,
conditional exemption under TSCA section 6(g), due to notable
differences in the two sectors. Specifically, exposure information
assessed by EPA resulted in key differences in risk estimates for paint
and coating removal by civilian aviation and DOD (see discussion in
this Unit and Unit V.A.1.). Additionally, as described in Unit V.A.1.,
Federal and Federal contractor facilities are subject to multiple
levels of oversight as a result of the governmental and public nature
of their activities, while many civilian aviation facilities are not
likely to experience the same level of scrutiny. EPA emphasizes that in
the absence of information, it must still ensure that unreasonable
risks are addressed. Because EPA has found inadequate information to
otherwise determine whether the unreasonable risk would be addressed
when using methylene chloride under a WCPP for commercial use of
methylene chloride for paint and coating removal from safety-critical,
corrosion-sensitive components of aircraft and aerospace vehicles for
commercial aviation and aerospace, EPA has determined that the proposed
exemption under TSCA section 6(g) allowing for time-limited,
conditional use of methylene chloride for this critical use is the
appropriate approach.
EPA recognizes that in some situations, certain facilities may do
both Federal contractor and commercial aviation work and may use
methylene chloride for paint and coating removal from safety-critical,
corrosion-sensitive components on military, Federal, or commercial
aviation. EPA requests comment on whether such co-located activities in
a facility should be subject to the WCPP, rather than the exemption
under TSCA section 6(g). Additionally, EPA seeks additional information
and requests comment on whether it is possible to distinguish between
commercial aviation facilities that would be able to meet the WCPP and
those that would not, including what criteria should be used for such
distinctions (e.g., size of facility, volume
[[Page 28311]]
or type of work performed, record of exposure reduction practices). EPA
also requests comment on the extent to which specific commercial
aviation and aerospace uses or types of facilities could fully comply
with the WCPP to address identified unreasonable risk.
ii. Proposed Exemptions for Uses of Methylene Chloride for Paint and
Coating Removal That Are Essential for Critical Infrastructure
For the reasons discussed in this Unit, EPA is proposing 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. In defining the scope
of the exemption to limit the exemption to commercial aviation and
aerospace, EPA looked to the definitions and provisions of the Federal
Aviation Regulations in title 14 of the CFR. Air carriers and
commercial operators are certificated under 14 CFR part 119. Repair
stations are certificated under 14 CFR part 145. To effectively prevent
significant disruptions to critical infrastructure including commercial
aviation and aerospace, EPA would make this exemption available to
three different groups of commercial entities. In each case, the
exemption would be available only for the use of methylene chloride to
remove paint and coatings from safety-critical, corrosion-sensitive
components of aircraft or aerospace vehicles. The first group would
consist of those facilities that primarily maintain and repair aircraft
used by air carriers and commercial operators. More specifically,
maintenance and repair facilities operated by air carriers and
commercial operators certificated under 14 CFR part 119 would be
eligible for the exemption, as would be repair stations certificated
under 14 CFR part 145, if their primary business is performing
maintenance, preventive maintenance, rebuilding, or alteration of
aircraft operated by air carriers and commercial operators certificated
under 14 CFR part 119. The second group would consist of manufacturers
of aircraft intended for, or capable of being used by, air carriers and
commercial operators certificated under 14 CFR part 119. The third
group would consist of any person manufacturing or repairing
spacecraft, space vehicles, or payloads or similar hardware that is
intended for, or used in, commercial space transportation operations
subject to 14 CFR chapter III.
The conditions for the proposed exemption would be: (1) The use of
methylene chloride for commercial paint or coating removal by
certificated air carriers, commercial operators, or repair stations, or
by manufacturers of aircraft or aerospace vehicles or hardware, would
be limited to the safety-critical, corrosion-sensitive components on
aircraft and aerospace vehicles; (2) The use of methylene chloride for
paint or coating removal would be required to be performed on the
premises of the certificated air carrier or commercial operator or
repair station, or of the manufacturer of aircraft or aerospace
vehicles or hardware; and (3) The certificated air carrier, commercial
operator, repair station, or manufacturer of aircraft or aerospace
vehicles and hardware manufacturer would have to comply with the WCPP
discussed in Unit IV.A.1.
EPA wishes to make clear that the exemption for the commercial
aerospace and aviation industry would only be available for the purpose
of paint and coating removal from components of aircraft and spacecraft
that are corrosion-sensitive and safety critical components, 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. In addition, these components would have to be of the type
that not only require their paint or coatings to be removed for
inspection and maintenance but also would be so negatively affected by
the use of paint and coating removal chemicals or methods other than
methylene chloride that the safety of the system could be compromised.
General paint and coating removal on aircraft and spacecraft would not
be authorized under this exemption. One commenter on the 2017 proposal
suggested that EPA clarify that only the manufacturer of the component
may make this determination. In EPA's view, persons availing themselves
of the exemption 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.
The entities subject to the proposed exemption would nonetheless
still be subject to the proposed general recordkeeping requirements
discussed in Unit IV.A., the WCPP recordkeeping requirements discussed
in Unit IV.A.1.f.iii., and requirements to maintain records that
demonstrate compliance with the exemption conditions, including the
condition that methylene chloride only be used for paint and coating
removal from corrosion-sensitive and safety critical components of an
aircraft or spacecraft. Pursuant to TSCA section 6(g)(3), if this
proposed exemption is finalized, EPA may by rule later extend, modify,
or eliminate the exemption, on the basis of reasonably available
information and after adequate public justification, if EPA determines
the exemption warrants a change. EPA would initiate this rulemaking
process (e.g., proposed rule, final rule) at the request of any
regulated entity benefiting from such an exemption, as appropriate. The
Agency is open to engagement throughout the duration of any TSCA
section 6(g) exemption, and emphasizes that to ensure continuity in the
event of an extension or modification request, such a request should
come at least 2 years prior to the expiration of an exemption.
EPA requests comments on all aspects of the proposed TSCA section
6(g) exemption from the proposed prohibition on use of methylene
chloride in commercial paint and coating removal for paint and coating
removal essential for critical infrastructure by certificated
commercial air carriers, commercial operators, or repair stations, or
by manufacturers of aircraft or aerospace vehicles and hardware, noting
that the proposed exemptions would be limited to the safety-critical,
corrosion-sensitive components on aircraft and aerospace vehicles,
including safety-critical components.
b. Certain Emergency Uses of Methylene Chloride for Which No
Technically and Economically Feasible Safer Alternative Is Available
i. Analysis of the Need for TSCA Section 6(g)(2)(A) Exemption for NASA
Certain Uses in an Emergency
EPA also considered a TSCA section 6(g) exemption for emergency use
of methylene chloride in the furtherance of NASA's mission. Under TSCA
section 6(g)(1)(A), EPA may ``grant an exemption from a requirement of
a . . . rule for a specific condition of use of a chemical substance or
mixture, if the Administrator finds that the specific condition of use
is a critical or essential use for which no technically and
economically feasible safer alternative is
[[Page 28312]]
available, taking into consideration hazard and exposure.'' For certain
specific conditions of use, EPA proposes that use of methylene chloride
by NASA and its contractors in an emergency be exempt from the
requirements of this rule because it is a critical or essential use
provided that (1) there is an emergency; and (2) NASA selected
methylene chloride because there are no technically or economically
feasible safer alternatives available during the emergency.
NASA operates on the leading edge of science seeking innovative
solutions to future problems where even small volumes of an otherwise
prohibited chemical substance could be vital to crew safety and mission
success. During interagency review, NASA expressed concerns that there
will likely be circumstances where a specific, EPA-prohibited condition
of use may be identified by NASA during an emergency as being needed in
order to avoid or reduce situations of harm or immediate danger to
human health, or the environment, or avoid imperiling NASA space
missions. In such cases, it is possible that no technically and
economically feasible safer alternative would be available that meets
the stringent technical performance requirements necessary to remedy
harm or avert danger to human health, the environment, or avoid
imperiling NASA space missions.
An emergency is a serious and sudden situation requiring immediate
action to remedy harm or avert danger to human health, the environment,
or to avoid imperiling NASA space missions. In NASA's case, there may
be instances where the emergency use of methylene chloride for specific
conditions of use is critical or essential to remedying harm or
averting danger to human health, the environment, or avoiding
imperiling NASA space missions. Because of the immediate and
unpredictable nature of emergencies described in this Unit and of the
less forgiving environments NASA operates in that offer little to no
margin for error, it is likely that, at the time of finalization of
this proposal, alternatives to emergency methylene chloride use may not
be available in a timely manner to avoid or reduce harm or immediate
danger (Ref. 39). In this way, these emergencies for particular
conditions of use meet the criteria for an exemption under TSCA section
6(g)(1)(A), because the emergency use of methylene chloride for listed
conditions of use is critical or essential and no technically and
economically feasible safer alternative will be available in a timely
manner, taking into consideration hazard and exposure.
In support of the TSCA section 6(g)(1)(A) emergency use exemption,
NASA submitted detailed criteria which they must use to screen,
qualify, and implement materials to be used in spacecraft equipment, as
well as historical case studies that outline the loss of life and loss
of assets in the discharge of previous missions. In one of several
examples detailed, the Apollo I command module fire that claimed the
lives of three American astronauts demonstrated the need for careful
testing and continuity of materials (Ref. 39). Moreover, due to NASA's
rigorous safety testing requirements under various environmental
conditions, technically and economically feasible safer alternatives
may not be readily available during emergencies and may require certain
conditions of use of methylene chloride to alleviate the emergency.
In another example, NASA identified a scenario concerning a mission
to the International Space Station (ISS) whereby, during a launch
evolution, the countdown was paused immediately prior to launch (T-2
minutes). NASA engineers identified a clogged filter and supply line as
the primary issue, which required immediate attention (i.e., line
flushing and filter cleaning). In this type of emergency scenario, an
already approved chemical substance rated for space system applications
is necessary to immediately remedy the situation. Although methylene
chloride was not used in this particular incident, if it were needed,
in the future to address such an emergency, then the proposed exemption
would allow for its lawful use--the countdown would resume and the
launch would occur. Conversely, without an exemption under the specific
condition of use (e.g., industrial and commercial use in non-aerosol
degreasers and cleaners), NASA's use of methylene chloride would be
otherwise prohibited, which would put NASA in an untenable position of
having to choose to either violate the law or place the mission (and
potentially the health and safety of its employees involved in the
mission) at risk.
As described in Unit IV.A.5.a., the identification and
qualification of compatible materials in the context of aviation is
iterative and involves expansive collaboration between original
equipment manufacturers, Federal agencies, and qualifying institutions.
This is equally, if not more so, the case in the context of human space
flight operations undertaken by NASA (Ref. 39). NASA's mission
architecture requirements often are developed many years in advance of
an actual launch occurring. As part of mission planning, space systems
are designed, full scale mock-ups are built, and mission critical
hardware is constructed using materials qualified for spaceflight. Once
NASA's mission architecture requirements are developed, NASA may need
to retain emergency access to methylene chloride because its
alternatives may not have yet gone through NASA's rigorous
certification process before their use. Allowing NASA to retain
emergency use of methylene chloride would reduce the chances that this
rule will hinder future space missions for which mission architecture
infrastructure is being developed or is already built. While NASA
considers alternatives to the chemical substances it currently uses in
its space system designs, NASA has not yet identified technically and
economically feasible alternatives to proven chemistries in many
current applications. While EPA acknowledges that the use of methylene
chloride in emergency situations may be necessary in the near term, it
is also EPA's understanding that NASA will continue its work to
identify and qualify alternatives to methylene chloride. Thus, as with
the exemption described in Unit IV.A.5.a., EPA is proposing an
exemption duration of 10 years.
ii. Proposed Exemption for Use of Methylene Chloride for Emergency Uses
in the Context of Human Space Flight for Certain Uses
For the reasons discussed in this Unit, EPA is proposing a 10-year
exemption for emergency use of methylene chloride in furtherance of
NASA's mission for the following specific conditions of use: Industrial
and commercial use as solvent for cold cleaning; Industrial and
commercial use 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 solvent that becomes part of a
formulation or mixture. EPA is also proposing to include additional
requirements as part of the exemption, pursuant to TSCA section
6(g)(4), including required notification and controls for exposure, to
the extent feasible: (1) NASA and its contractors must provide notice
to the EPA Administrator of each instance of emergency use within 15
days and; (2) NASA and its contractors would have to comply with the
WCPP described in Unit IV.A.1. to the extent feasible.
[[Page 28313]]
EPA is proposing to require that NASA notify EPA within 15 days of
the emergency use. The notification would include a description of the
specific use of methylene chloride in the context of one of the
conditions of use for which this exemption is being proposed, an
explanation of why the use described qualifies as an emergency, and an
explanation with regard to the lack of availability of technically and
economically feasible alternatives.
As with the exemption described in Unit IV.A.5.a., EPA expects NASA
and its contractors have the ability to implement a WCPP as described
in Unit IV.A.1. for the identified uses in the context of an emergency,
to some extent even if not to the full extent of WCPP implementation.
Therefore, EPA is proposing to require that during emergency use, NASA
must comply with the WCPP to the extent technically feasible in light
of the particular emergency.
Under the proposed exemption, NASA and its contractors would still
be subject to the proposed general recordkeeping requirements discussed
in Unit IV.A.
EPA requests comment on this TSCA section 6(g) exemption for
continued emergency use of methylene chloride in the furtherance of
NASA's mission as described in this Unit, and whether any additional
conditions of use should be included, in particular for any uses
qualified for space flight for which no technically or economically
feasible safer alternative is available. Additionally, EPA requests
comment on what would constitute sufficient justification of an
emergency.
c. Analysis of the Need for a TSCA Section 6(g) Exemption for
Commercial Furniture Refinishing
While EPA in the past has proposed to exclude commercial furniture
refinishing from regulation of the use of methylene chloride in
commercial paint and coating removal, this proposed rule does not
exclude commercial furniture refinishing from the proposed prohibition
on the use of methylene chloride for commercial paint and coating
removal, because EPA has determined that this use drives the
unreasonable risk for methylene chloride, reasonably available
information demonstrates that alternative methods or substitute
chemicals are available to some extent, and, based on reasonably
available information, EPA has not found that a TSCA section 6(g)
exemption is warranted for the use of methylene chloride in commercial
furniture refinishing.
The 2020 Risk Evaluation for Methylene Chloride identified risks
for commercial use of methylene chloride in paint and coating removal,
including furniture refinishing, as a result of acute and chronic non-
cancer exposures that would not be mitigated by an APF 50 respirator.
The 2020 Risk Evaluation for Methylene Chloride identified risks for
commercial use of methylene chloride in paint and coating removal,
including furniture refinishing, as a result of acute and chronic non-
cancer exposures that would not be mitigated by an APF 50 respirator.
EPA identified many alternative products for paint and coating
removers. However, some may require longer periods of time or rework of
equipment and processes in order to work for furniture refinishing
uses, or, though they may be used as paint and coating removers in
other contexts, may not be appropriate alternatives for use on wood
substrates. EPA's consideration of alternatives, including for safety
and flammability, is discussed further in Unit V.B., the Economic
Analysis, and Alternatives Assessment (Ref. 3, Ref. 40). Mechanical or
thermal methods (i.e., sanding, media blasting, or heat guns) are also
potential alternatives for this sector, though likewise they may damage
the substrate, require different processes, and often requires more
time (Refs. 33, 55, 66). While the economic impacts of prohibiting the
commercial use of methylene chloride for furniture refinishing may be
significant for this sector, it is unclear whether this will result in
firm closures, and, if so, how many. Given the magnitude of the risks
resulting from this use, including the documented fatalities (Ref. 32),
the likely inability of this sector to comply with a WCPP (as described
in Unit V.A.), and the availability of some alternatives, EPA
determined that a prohibition would be necessary the identified risks
that drive the unreasonable risk to health, as discussed in Unit V.A.1.
EPA requests comment on all aspects of this preliminary determination
that a TSCA section 6(g) exemption is not warranted for the use of
methylene chloride in furniture refinishing, including information on
the availability of alternatives and the time needed to implement
alternatives. EPA emphasizes that the Agency is seeking input regarding
whether an exemption is needed and welcomes information related to this
condition of use during the public comment period.
B. Primary Alternative Regulatory Action
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA
must consider the costs and benefits and the cost effectiveness of the
proposed regulatory action and one or more primary alternative
regulatory actions considered by the Agency. An overview of the
proposed regulatory action and alternative regulatory action for each
condition of use is in Unit IV.C.
The primary alternative regulatory action described in this notice
combines prohibitions and requirements for a WCPP to address the
unreasonable risk from methylene chloride driven by the various
conditions of use, as well as time-limited exemptions under TSCA
section 6(g) for two uses. While in some ways it is similar to the
proposed regulatory action, the primary alternative regulatory action
described in this notice would allow a WCPP, including requirements to
meet an ECEL and EPA STEL, for several additional conditions of use
than would be allowed under the proposed regulatory action. The
alternative regulatory action additionally would include longer
compliance timeframes for prohibitions and a WCPP, as described in this
Unit.
As in the proposed regulatory action described in Unit IV.A.1.,
EPA's primary alternative regulatory action described in this notice
would include WCPP, including requirements to meet an ECEL and EPA STEL
for: manufacturing: domestic manufacture; manufacturing: import;
processing: as a reactant; processing: incorporation into a
formulation, mixture, or reaction product; processing: repackaging;
processing: recycling; industrial and commercial use as a laboratory
chemical; and disposal.
In addition, the primary alternative regulatory action described in
this notice would require a WCPP for 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.
[[Page 28314]]
EPA believes a WCPP may be a viable alternative to the proposed
prohibition for these additional industrial and commercial conditions
of use because, as discussed in Unit V.A., these conditions of use are
generally industrial in nature; owners or operators are likely
currently complying with the OSHA methylene chloride standard, so they
should be familiar with what is being required to meet the ECEL; and,
as far as the Agency is aware, these conditions of use have not
resulted in any documented fatalities. Because of the industrial nature
of the sectors relevant to these conditions of use, the owner or
operator may have the capability to successfully implement a WCPP to
ensure that the unreasonable risk, as a result of exposure to methylene
chloride, are prevented. However, at the time of proposal, EPA has not
yet received any monitoring data or detailed description of methylene
chloride involving activities for these conditions of use to confirm
that compliance with an ECEL of 2 ppm is possible. Therefore, concerns
about the feasibility of implementing an ECEL for these additional
industrial and commercial conditions of use, as discussed in Unit V.3.,
led EPA to propose that they be prohibited (see Unit IV.A.2.). EPA does
not have sufficient information to confidently conclude that facilities
engaged in these conditions of use could meet the ECEL for methylene
chloride.
Therefore, EPA requests comment on the ways in which methylene
chloride may be used in the conditions of use that would be prohibited
(under the proposed regulatory action) due to concerns about
feasibility of implementing an ECEL, and the degree to which users of
methylene chloride in these sectors could successfully implement the
WCPP, including requirements to meet an ECEL and EPA STEL, described in
Unit IV.A.1. EPA is also requesting comment on whether to consider a
regulatory alternative that would subject more conditions of use to a
WCPP, instead of prohibition, than those currently contemplated in the
primary alternative regulatory action. EPA also requests monitoring
data and detailed descriptions of 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.
Specifically with regards to the condition of use ``Industrial and
commercial use as a processing aid,'' EPA notes that the description of
this condition of use (in Unit III.B.1.c.xxiii.) covers a broad range
of chemical use activities. During the SBAR Panel, one SER provided
process descriptions, diagrams, and monitoring data which indicated
that particular entity may already be able to meet an ECEL of 2 ppm.
This particular entity uses methylene chloride as a heat transfer fluid
in a closed system. Information provided to EPA indicated that
inhalation exposures were frequently below the ECEL and in some cases
below the level of detection, and while dermal exposure were possible,
they could be mitigated through use of PPE (Ref. 6). EPA's 2020 Risk
Evaluation for Methylene Chloride incorporated exposure estimates from
a different type of processing aid application that did not resemble
the SER's use, which is highly specialized and may be considered a sub-
use of the condition of use as a whole. EPA requests comment on the
degree to which other entities using methylene chloride as a processing
aid may otherwise comply with the proposed WCPP requirements for
methylene chloride. In the case that several entities are able to
demonstrate the continued use of methylene chloride without subjecting
workers to unreasonable risk is possible, through a combination of
monitoring data and process description, EPA acknowledges its
willingness to finalize a regulation under which this particular sub-
use of the condition of use, or the condition of use as a whole could
continue under the WCPP.
Additionally, EPA notes that the alternatives analysis did not
specifically identify any alternatives for this condition of use (Ref.
40). This is a limitation of the type of analysis done, which was
specifically based on the use of alternative formulations currently on
the market, and therefore not applicable to most processing uses. EPA
emphasizes that this is not a positive finding that alternatives do not
exist for this condition of use. To that end, EPA requests comment on
the degree to which alternatives may or may not be available for use of
methylene chloride as a heat transfer fluid and in other processing aid
applications.
In the event that EPA is not able to identify any alternatives for
this condition of use, and additional information is not provided that
would allow EPA to determine that the WCPP could address unreasonable
risk driven by this condition of use, EPA will consider finalizing a
prohibition that allows for an appropriate phaseout in accordance with
TSCA section 6(d). Alternatively, in the event that EPA is unable to
identify alternatives for this condition of use, and EPA determines
through new information provided that prohibition of the use would
significantly impact national security or critical infrastructure, EPA
will consider an exemption under TSCA section 6(g).
Under the primary alternative regulatory action, EPA would prohibit
the manufacture, processing, and distribution in commerce of methylene
chloride for all consumer use. Additionally, under the primary
alternative regulatory action described in this notice and considered
by EPA, other than those conditions of use listed earlier for inclusion
under the WCPP, EPA would prohibit the remaining industrial and
commercial uses, including two uses for which EPA is proposing the WCPP
as the regulatory action: industrial or commercial use for paint and
coating removal from safety-critical, corrosion-sensitive components of
aircraft and spacecraft by Federal agencies and their contractors; and
industrial or commercial use as a bonding agent in the production of
specialty batteries for military or space applications by Federal
agencies and their contractors. Recordkeeping and downstream
notification would be required as described in Unit IV.A.4.
For industrial or commercial use for paint and coating removal from
safety-critical, corrosion-sensitive components of aircraft and
spacecraft by Federal agencies and their contractors, and industrial or
commercial use as a bonding agent in the production of specialty
batteries for military or space applications by Federal agencies and
their contractors, the alternative regulatory action would include an
exemption from the prohibition for 10 years under TSCA section 6(g).
For the duration of this exemption, regulated entities would be
required to comply with the WCPP to the extent practicable.
For these two uses, EPA has conducted an analysis of the
application of this rulemaking and found that a TSCA section 6(g)
exemption may be warranted if the primary alternative regulatory action
considered by EPA is adopted, in its entirety or in relevant part, in
the final rule. Based on discussions with and information provided by
industry stakeholders, EPA understands that these two uses of methylene
chloride by DoD, NASA, and other Federal agencies are essential for
national security and critical infrastructure.
As discussed in greater detail in Unit V.B., EPA is aware that
there are specific military uses for which methylene chloride is
essential for paint and coating removal and for which there are no
suitable alternatives currently available. The military readiness of
DOD's warfighting capability is
[[Page 28315]]
paramount to ensuring national security, which includes ensuring the
maintenance and preservation of DOD's warfighting assets. DOD has
identified safety-critical uses of methylene chloride for ensuring
military aviation readiness. These consist of the use of methylene
chloride for the removal of coatings from safety-critical, corrosion-
sensitive military aviation components, such as landing gear, gear
boxes, and turbine engine parts, that not only require their coatings
be removed for inspection and maintenance but also would be so
negatively affected by the use of technically incompatible, substitute
paint removal chemicals or methods that the safe performance of the
aircraft could be compromised.
EPA has evaluated the effect that a prohibition on methylene
chloride for industrial or commercial paint and coating removal could
have on military readiness and preliminarily determines that an
exemption would be warranted under TSCA section 6(g)(1)(B) to avoid the
significant deleterious impacts on national security that compliance
with the proposed prohibition could entail, should the primary
alternative regulatory action be adopted in the final rule in whole or
in part. More specifically, because the available alternatives either
cannot be used on certain substrates, such as high-strength steel or
magnesium, or take an unacceptably long time to work in certain
situations, compliance with the proposed prohibition would result in
important military assets being off-line for significantly longer
inspection and repair periods, which would significantly disrupt
national security.
In addition, as noted by commenters on EPA's 2017 NPRM, there are
other Federal agencies that use safety-critical, corrosion-sensitive
components on aviation and space applications and stated that the
proposed exemption should also apply to those Federal agencies and
their contractors. These commenters asserted that, without an exemption
for NASA, the Department of Homeland Security (DHS), and the Federal
Aviation Administration (FAA), the proposed prohibition on the use of
methylene chloride for industrial or commercial paint and coating
removal could negatively affect national security and critical
infrastructure.
EPA's analysis of the potential impacts on DOD's military readiness
and national security is equally applicable to NASA, DHS, and FAA. As
stated by commenters on EPA's 2017 NPRM (Ref. 46), aircraft and other
assets operated by DHS, NASA, and the FAA also contain safety-critical,
corrosion-sensitive components of the type described by DOD, and
suitable alternatives to methylene chloride are similarly not available
for all applications. Those agencies are also responsible for assets
that are essential to national security or constitute critical
infrastructure and contain safety-critical, corrosion-sensitive
components on which methylene chloride is used for paint and coating
removal. The Coast Guard, one of the five Armed Services of the United
States, is a military branch within DHS. Like the four Armed Services
within DOD, the Coast Guard is also responsible for warfighting assets
that may require the use of methylene chloride for the removal of
coatings from safety-critical, corrosion-sensitive components. The
Coast Guard's military readiness is as important as the military
readiness of the four Armed Services within DOD. Similarly, the
readiness of U.S. Customs and Border Protection aviation for monitoring
and protecting the borders of the United States is an integral part of
national security. As for NASA, the United States Space Priorities
Framework notes that space systems (e.g., flight components of
satellites and space craft) are part of the nation's critical
infrastructure and that the United States has significant national
security interests in space (Ref. 41). The integrity and performance of
our national airspace system, overseen by the FAA, is a matter of both
national security and critical infrastructure. FAA-operated aircraft
ensure the integrity of instrument approaches to airports and airway
procedures that constitute our National Airspace System infrastructure
(Ref. 42). The FAA's Flight Program Operations accomplishes this
through the airborne inspection of space- and ground-based instrument
flight procedures and the validation of electronic signals in space
transmitted from ground navigation systems, evaluating accuracy,
aeronautical data, human factors fly-ability, and obstacle clearance.
As discussed in Unit V.B., substitute chemicals for paint and
coating removal for safety-critical, corrosion-sensitive components are
not technically feasible as they have one or more technical
limitations; are incompatible with underlying materials; and/or do not
support the coating removal requirements of safety inspections, non-
destructive inspection, material assessment, or field repair processes.
Therefore, EPA has preliminarily determined that DHS, NASA, and FAA
compliance with a prohibition on the use of methylene chloride for
industrial or commercial paint and coating removal, which would
preclude use of methylene chloride for removal of paint and coatings
from safety-critical, corrosion-sensitive components of these agencies'
aircraft and other assets, would significantly disrupt national
security and critical infrastructure in the same way that DOD's
compliance with a prohibition would. In addition, due to concerns about
impacts to the availability of methylene chloride for use in removing
paint and coatings from safety-critical, corrosion-sensitive
components, EPA has preliminarily determined that a ban on the
manufacture, processing, and distribution in commerce of methylene
chloride for industrial or commercial paint and coating removal for
these safety-critical, corrosion-sensitive components would also
significantly disrupt national security and critical infrastructure.
For this reason, if the primary alternative regulatory action
considered by EPA is adopted, in its entirety or in relevant part, in
the final rule, an exemption under TSCA section 6(g) would be warranted
to prevent significant disruption of national security and critical
infrastructure.
EPA has also analyzed the need for a TSCA section 6(g) exemption
for use of methylene chloride as a bonding agent in the production of
specialty batteries for use in critical energy storage applications in
military and space exploration settings, including defense applications
such as precision guided weapons, military airframes, satellites, space
launch vehicles, and spacecraft. According to a maker of these
batteries, all major military and space applications, such as aircraft
(F-35, B2), radios, and Mars mission equipment, require these batteries
to function in very harsh conditions, including operation to -40 [deg]C
and storage at -54 [deg]C (Ref. 47). As discussed further in Unit V.B.,
EPA understands that methylene chloride is a superior bonding agent for
this process because of its unique evaporative qualities, and that
availability of technologically and economically feasible alternatives
to methylene chloride is lacking.
As discussed in this Unit, EPA recognizes that military readiness
is paramount to ensuring national security, and that space systems are
part of our critical infrastructure and have impacts on national
security. Therefore, EPA has preliminarily determined that DOD and NASA
compliance with a prohibition on the use of methylene chloride as a
bonding agent in the production of specialty batteries for use in
critical energy storage applications in military and space exploration
settings would significantly disrupt national security and critical
infrastructure,
[[Page 28316]]
should the primary alternative regulatory action be adopted in the
final rule in whole or in part. In addition, due to concerns about
impacts to the availability of methylene chloride for use as a bonding
agent in the production of these specialty batteries, EPA has
preliminarily determined that a prohibition on the manufacture,
processing, and distribution in commerce of methylene chloride for use
as a bonding agent in the production of specialty batteries for use in
critical energy storage applications in military and space exploration
settings would also significantly disrupt national security and
critical infrastructure. For this reason, if the primary alternative
regulatory action considered by EPA is adopted, in its entirety or in
relevant part, in the final rule, an exemption under TSCA section 6(g)
would be warranted to prevent significant disruption of national
security and critical infrastructure.
Given the potential severity of impacts from acute exposures, EPA's
proposed regulatory action would include relatively rapid compliance
timeframes. However, it is possible that longer timeframes would be
needed for entities to come into compliance; therefore, the primary
alternative regulatory action described in this notice would include
longer timeframes for implementation than the proposed regulatory
action. The prohibitions under the primary alternative regulatory
action would take effect in 360 days for manufacturers, 450 days for
processers, 540 days for distributing to retailers, 630 days for all
other distributors and retailers, and 720 days for industrial and
commercial users after publication of the final rule in the Federal
Register (in contrast to 90 days for manufacturers, 180 days for
processers, 270 days for distributing to retailers, 360 days for all
other distributors and retailers, and 450 days for industrial and
commercial users after publication of the final rule in the Federal
Register in the proposed action described in Unit IV.A.). Similarly,
the compliance timeframes for the WCPP under the primary alternative
regulatory action would be extended by 6 months in comparison to the
proposed action described in Unit IV.A: EPA would require that
regulated entities establish initial exposure monitoring according to
the process outlined in Unit IV.A. within 12 months, ensure that the
airborne concentration of methylene chloride does not exceed the ECEL
or EPA STEL within 15 months (and provide respiratory protection if
necessary), and implement an exposure control plan within 18 months.
EPA requests comment on the ability of regulated entities engaged in
the additional conditions of use that would be subject to a WCPP under
the primary alternative regulatory action to conduct initial monitoring
within 12 months, anticipated timelines for any procedural adjustments
needed to comply with the requirements, and the extent to which this
option could result in additional exposure, compared the proposed
regulatory option as described in Unit IV.A. Overall, EPA requests
comment on any advantages or drawbacks for the timelines outlined in
this Unit, compared to the timelines identified for the proposed
regulatory action in Unit IV.A.
As noted earlier in this Unit, for some conditions of use, both the
proposed regulatory action and primary alternative regulatory action
would result in a prohibition. EPA emphasizes that for those conditions
of use, the primary alternative regulatory action includes a different
timeline for implementation of the prohibition, in comparison to the
proposed regulatory action. As discussed in more detail in Unit V.A.,
for those conditions of use, EPA also considered other regulatory
approaches available under TSCA section 6(a). However, EPA found that
none of these other regulatory approaches would address the
unreasonable risk.
Where EPA has determined that a chemical substance presents
unreasonable risk under TSCA section 6(b)(4), EPA must undertake
rulemaking to ``apply one or more of the [TSCA Sec. 6(a)(1) through
(7)] requirements to such substance . . . to the extent necessary so
that the chemical substance . . . no longer presents such risk.'' TSCA
Sec. 6(a). ``In proposing and promulgating [such] a rule,'' EPA must
``consider and publish a statement based on reasonably available
information with respect to . . . the reasonably ascertainable economic
consequences of the rule, including consideration of . . . (II) the
costs and benefits of the proposed . . . regulatory action and of the
[one] or more primary alternative regulatory actions considered by
[EPA]; and (III) the cost effectiveness of the proposed regulatory
action and of the [one] or more primary alternative regulatory actions
considered by [EPA].'' EPA interprets this to mean that Congress
intended this ``primary alternative regulatory action'' to be another
regulatory option under TSCA Sec. 6(a)(1) through (7) that would meet
the requirements of TSCA Sec. 6(a), namely address the unreasonable
risk identified under TSCA section 6(b)(4) ``to the extent necessary so
that the chemical substance . . . no longer presents such risk.'' Here,
the proposed regulatory action is comprised of a mix of proposed
options under TSCA section 6(a), each directed at specific conditions
of use and with specified timeframes for compliance. The primary
alternative regulatory options considered by the Agency would adjust
the overall mix of TSCA section 6(a) requirements, including compliance
timeframes, resulting in a proposed regulatory action that is more
restrictive in some ways and less restrictive in others. For conditions
of use where the only options that would address the unreasonable risk
are prohibition options under TSCA Sec. 6(a)(2), the proposed option
and the primary alternative regulatory option are distinct because
implementing prohibitions on differing timetables under TSCA section
6(d) would result in a different mix of regulatory options with
different costs, benefits, and cost effectiveness than the proposed
regulatory action.
C. Overview of Conditions of Use and Proposed Regulatory Action and
Primary Alternative Regulatory Action
The following Table 3 is a side-by-side depiction of the proposed
regulatory action with the primary alternative regulatory action for
each condition of use. Additionally, timeframes between the proposed
and primary alternative regulatory action differ as outlined in Units
IV.A. and B; those Units also contain additional details such as
exemptions proposed under TSCA section 6(g) and delayed compliance
dates under TSCA section 6(d) for specific applications.
[[Page 28317]]
Table 3--EPA Proposed or Alternative Action by Condition of Use
------------------------------------------------------------------------
Action
--------------------------------------
Condition of use Primary
Proposed alternative
regulatory action action
------------------------------------------------------------------------
Industrial and commercial use as Prohibit.......... Prohibit.
solvent for batch vapor
degreasing.
Industrial and commercial use as Prohibit.......... Prohibit.
solvent for in-line vapor
degreasing.
Industrial and commercial use as Prohibit.......... Prohibit.
solvent for cold cleaning.
Industrial and commercial use as Prohibit.......... Prohibit.
a solvent for aerosol spray
degreaser/cleaner.
Industrial and commercial use in Prohibit.......... Prohibit.
adhesives, sealants and caulks.
Industrial and commercial use in Prohibit.......... Prohibit.
paints and coatings.
Industrial and commercial use in Prohibit.......... Prohibit.
paint and coating removers.
Industrial and commercial use in WCPP.............. Prohibit, with a
paint and coating removers from 10-year time-
safety critical, corrosion- limited
sensitive components of aircraft exemption and
and spacecraft owned or operated interim WCPP.
by DOD, NASA, DHS, FAA.
Industrial and commercial use in Prohibit, with a WCPP.
paint and coating removers from 10-year time-
safety-critical, corrosion- limited exemption
sensitive components of aircraft and interim WCPP.
owned or operated by air
carriers or commercial operators.
Industrial or commercial use as a WCPP.............. Prohibit, with a
bonding agent for acrylic and 10-year time-
polycarbonate in mission- limited
critical military and space exemption and
vehicle applications, including interim WCPP.
in the production of specialty
batteries for such applications.
Industrial and commercial use in Prohibit.......... Prohibit.
adhesive and caulk removers.
Industrial and commercial use in Prohibit.......... Prohibit.
metal aerosol degreasers.
Industrial and commercial use in Prohibit.......... Prohibit.
metal non-aerosol degreasers.
Industrial and commercial use in Prohibit.......... WCPP.
finishing products for fabric,
textiles and leather.
Industrial and commercial use in Prohibit.......... Prohibit.
automotive care products
(functional fluids for air
conditioners).
Industrial and commercial use in Prohibit.......... Prohibit.
automotive care products
(interior car care).
Industrial and commercial use in Prohibit.......... Prohibit.
automotive care products
(degreasers).
Industrial and commercial use in Prohibit.......... Prohibit.
apparel and footwear care
products.
Industrial and commercial use in Prohibit.......... Prohibit.
spot removers for apparel and
textiles.
Industrial and commercial use in Prohibit.......... Prohibit.
liquid lubricants and greases.
Industrial and commercial use in Prohibit.......... Prohibit.
spray lubricants and greases.
Industrial and commercial use in Prohibit.......... Prohibit.
aerosol degreasers and cleaners.
Industrial and commercial use in Prohibit.......... Prohibit.
non-aerosol degreasers and
cleaners.
Industrial and commercial use in Prohibit.......... Prohibit.
cold pipe insulations.
Industrial and commercial use as Prohibit.......... WCPP.
solvent that becomes part of a
formulation or mixture.
Industrial and commercial use as Prohibit.......... WCPP.
a processing aid.
Industrial and commercial use as Prohibit.......... Prohibit.
a propellant and blowing agent.
Industrial and commercial use for Prohibit.......... WCPP.
electrical equipment, appliance,
and component manufacturing.
Industrial and commercial use for Prohibit.......... WCPP.
plastic and rubber products
manufacturing.
Industrial and commercial use in Prohibit.......... WCPP.
cellulose triacetate film
production.
Industrial and commercial use as Prohibit.......... Prohibit.
anti-spatter welding aerosol.
Industrial and commercial use for Prohibit.......... WCPP.
oil and gas drilling,
extraction, and support
activities.
Industrial and commercial use in Prohibit.......... Prohibit.
toys, playground and sporting
equipment.
Industrial and commercial use in Prohibit.......... Prohibit.
carbon remover, wood floor
cleaner, and brush cleaner.
Industrial and commercial use in Prohibit.......... Prohibit.
lithographic printing plate
cleaner.
Consumer use as solvent in Prohibit\1\....... Prohibit.\1\
aerosol degreasers/cleaners.
Consumer use in adhesives and Prohibit \1\...... Prohibit.\1\
sealants.
Consumer use in brush cleaners Prohibit \1\...... Prohibit.\1\
for paints and coatings.
Consumer use in adhesive and Prohibit \1\...... Prohibit.\1\
caulk removers \1\.
Consumer use in metal degreasers. Prohibit \1\...... Prohibit.\1\
Consumer use in automotive care Prohibit \1\...... Prohibit.\1\
products (functional fluids for
air conditioners).
Consumer use in automotive care Prohibit \1\...... Prohibit.\1\
products (degreasers).
Consumer use in lubricants and Prohibit \1\...... Prohibit.\1\
greases.
Consumer use in cold pipe Prohibit \1\...... Prohibit.\1\
insulation.
Consumer use in arts, crafts, and Prohibit \1\...... Prohibit.\1\
hobby materials glue.
Consumer use in an anti-spatter Prohibit \1\...... Prohibit.\1\
welding aerosol.
Consumer use in carbon removers Prohibit \1\...... Prohibit.\1\
and other brush cleaners.
Manufacturing (Domestic WCPP.............. WCPP.
manufacturing).
Manufacturing (Import)........... WCPP.............. WCPP.
Processing: processing as a WCPP.............. WCPP.
reactant.
Processing: incorporation into a WCPP.............. WCPP.
formulation, mixture, or
reaction product.
Processing: repackaging.......... WCPP.............. WCPP.
Processing: recycling............ WCPP.............. WCPP.
Industrial and commercial use as WCPP.............. WCPP.
a laboratory chemical.
Disposal......................... WCPP.............. WCPP.
------------------------------------------------------------------------
\1\ Prohibit manufacture, processing, and distribution in commerce for
the consumer use.
[[Page 28318]]
V. Rationale for the Proposed Regulatory and Primary Alternative
Regulatory Actions
This Unit describes how the considerations described in Unit
III.B.3. were applied when selecting among the TSCA section 6(a)
requirements to arrive at the proposed and primary alternative
regulatory actions described in Unit IV.A. and B.
A. Consideration of Risk Management Requirements Available Under TSCA
Section 6(a)
1. Workplace Chemical Protection Program (WCPP)
One option EPA considered for occupational conditions of use was
establishing a WCPP, which would include an ECEL and related required
implementation measures, such as monitoring. As described in Unit
IV.A.1., the WCPP for methylene chloride would be non-prescriptive, in
the sense that owners and operators would not be required to use
specific equipment or engineering controls prescribed by EPA to achieve
the exposure concentration limit. Rather, a performance-based exposure
limit would enable owners and operators to determine how to most
effectively meet the exposure limits based on conditions at their
workplace, aligned with the hierarchy of controls. However, due to the
low exposure levels and stringent requirements in the WCPP necessary to
address the unreasonable risk from methylene chloride, EPA identified
only a relatively small number of conditions of use where the Agency
expects the WCPP can be successfully implemented.
The central components of the WCPP are the ECEL and EPA STEL. EPA
has determined as a matter of risk management policy that ensuring
exposures remain at or below the ECEL and EPA STEL would eliminate any
unreasonable risk of injury to health driven by inhalation exposures
for occupational conditions of use subject to the WCPP.
In the case of methylene chloride, EPA has calculated the ECEL for
methylene chloride to be 2 ppm (8 mg/m\3\) for inhalation exposures as
an 8-hour TWA in workplace settings, based on the chronic non-cancer
human equivalent concentration for liver toxicity from inhalation
exposures. This is the concentration at which an adult human, including
a member of a susceptible subpopulation, would be unlikely to suffer
adverse effects if exposed for a working lifetime (Ref. 11). EPA chose
the chronic non-cancer liver toxicity endpoint as the basis for this
exposure limit as it is the most sensitive of the endpoints identified,
and therefore will be protective of both acute and chronic cancer
inhalation endpoints over the course of a working day and lifetime.
However, the well-established and severe acute hazard identified
for methylene chloride, from blurred vision to death, can be
experienced in much shorter timeframes. Therefore, EPA determined a
short-term exposure limit, or EPA STEL, of 16 ppm (57 mg/m\3\) as a 15-
minute TWA, based on the non-cancer endpoint of central nervous system
depression resulting from acute exposures, was necessary in order to
ensure the unreasonable risk was fully addressed in occupational
settings (Ref. 11).
Once EPA identified the appropriate risk-based inhalation limits to
address identified unreasonable risk, EPA carefully considered the
appropriateness of such a program for each occupational condition of
use of methylene chloride, in the context of the unreasonable risk.
Particular factors related to work activities that may make it
difficult for certain conditions of use to comply with an ECEL are
worth further discussion. One example includes work activities that may
take place in the field, such as on-site paint removal or the use of
adhesives in construction or renovation, making it challenging to
establish a regulated area and conduct monitoring. In other contexts,
the donning of air-supplied respirators would create challenges for
movement and feasibility of work activities that may take place in
small, enclosed spaces. Similarly, work activities that require a high
range of motion or for some other reason could create challenges for
the implementation of respiratory PPE are not good candidates for a
WCPP, such as use as an anti-spatter welding aerosol, where use of a
welding mask would impede the donning of an air-supplied respirator.
EPA also considered the feasibility of exposure reduction
sufficient to address the unreasonable risk, even in facilities
currently complying with the OSHA methylene chloride standard. While
EPA acknowledges the regulated community's expected familiarity with
OSHA PELs generally, as well as facilities' past and ongoing actions to
implement the methylene chloride PEL and corresponding methods of
compliance in OSHA's methylene chloride standard, EPA's exposure limits
would be a full order of magnitude lower than the OSHA PEL. (The
differences between the ECEL and EPA STEL and the OSHA PEL are
discussed in more detail in Unit II.C.4.) This creates a significant
amount of uncertainty as to the ability of facilities engaging in most
industrial and commercial conditions of use to meet the ECEL and EPA
STEL (and associated action levels) without relying on the use of PPE
(or as discussed previously, if the nature of the activity precludes
use of PPE required to meet such a level), and, therefore, whether
exposures could be reduced in a manner aligned with the hierarchy of
controls, because under that hierarchy PPE is considered a measure of
last resort.
EPA understands that this uncertainty extends to the applicability
of respirators as well. Although respirators, specifically SCBAs, could
reduce exposures to levels that are protective of non-cancer and cancer
risks, not all workers may be able to wear respirators. Individuals
with impaired lung function due to asthma, emphysema, or chronic
obstructive pulmonary disease, for example, may be physically unable to
wear a respirator. OSHA requires that a determination regarding the
ability to use a respirator be made by a physician or other licensed
health-care professional, and annual fit testing is required for tight-
fitting, full-face piece respirators to provide the required
protection. Individuals with facial hair, such as beards or sideburns
that interfere with a proper face-to-respirator seal, cannot wear tight
fitting respirators. In addition, respirators may also present
communication problems, vision problems, worker fatigue, and reduced
work efficiency (63 FR 1152, January 8, 1998). According to OSHA,
``improperly selected respirators may afford no protection at all (for
example, use of a dust mask against airborne vapors), may be so
uncomfortable as to be intolerable to the wearer, or may hinder vision,
communication, hearing, or movement and thus pose a risk to the
wearer's safety or health'' (63 FR 1189 through 1190).
In contrast to considerations that would weigh against the
likelihood of a facility within a condition of use to successfully
implement WCPP, there are certain considerations that indicate a
condition of use is a good fit for effective risk management via WCPP.
Based on reasonably available information, including monitoring data,
and information related to considerations described previously in this
Unit, EPA's confidence that requirements to meet an ECEL and EPA STEL
can be implemented is highest for highly standardized and
industrialized settings, such as where methylene chloride is used in a
closed system.
[[Page 28319]]
For example, one of the conditions of use for which EPA is
proposing to require compliance with the WCPP is processing of
methylene chloride as a reactant. A large volume of methylene chloride
is processed for this condition of use, which almost entirely goes
towards the manufacture of the hydrofluorocarbon HFC-32 (Refs. 3, 44).
Monitoring data and exposure information submitted by industry,
including by small entity representatives as part of the SBAR process,
suggests that methylene chloride exposures in some facilities may
already be below levels that would be consistent with the proposed ECEL
(Refs. 6, 45, 46). Additionally, HFC-32 is one of the regulated
substances identified in the AIM Act. Among other things, the AIM Act
authorizes EPA to address listed HFCs in three main ways: phasing down
HFC production and consumption through an allowance allocation program;
facilitating sector-based transitions to next-generation technologies;
and issuing certain regulations for purposes of maximizing reclamation
and minimizing releases of HFCs and their substitutes from equipment
and ensuring the safety of technicians and consumers. EPA anticipates
that many entities currently using HFCs with higher global warming
potential will transition to alternatives with lower global warming
potential as requirements under the AIM Act take effect. HFC-32, while
being one regulated substance subject to the overall phasedown in
production and consumption of regulated substances under the AIM Act,
is likely to be used to facilitate the transition from other HFCs and
HFC blends with higher global warming potential in certain
applications. By allowing for the continued, controlled use of
methylene chloride in the manufacture of HFC-32, efforts to shift to
chemicals with lower global warming potential would not be impeded by
this rulemaking. Allowing this use to continue, subject to compliance
with the WCPP, would complement industry's ongoing effort to abate the
use of hydrofluorocarbons with higher global warming potential.
An additional strong candidate for WCPP is industrial and
commercial use of methylene chloride as a laboratory chemical.
Laboratory settings are expected to be more conducive to the
implementation of engineering controls such as fume hoods to ventilate
vapors and adequately reduce overall exposure to methylene chloride
consistent with the hierarchy of controls.
For both these conditions of use (processing of methylene chloride
as a reactant and industrial and commercial use as a laboratory
chemical), the 2020 Risk Evaluation for Methylene Chloride indicates
that only small reductions in exposure are needed for WCPP compliance.
Based on analysis in the 2020 Risk Evaluation for Methylene Chloride
describing expected exposures with and without use of PPE, EPA
identified an air-supplied respirator of APF 25 as the minimum
respiratory PPE that is sufficient to mitigate the unreasonable risk
driven by both of these conditions of use (note for OSHA APF 25 is the
minimum allowable respiratory PPE for methylene chloride, as filter and
cartridge respirators are not protective against methylene chloride
vapors). This suggested that, for these conditions of use, the
reductions in exposure required to achieve a level that would not
present unreasonable risk may be less than in other instances, which,
together with other considerations previously described, including
monitoring data indicating exposures near or below the ECEL, adds to
EPA's confidence that facilities engaging in these two conditions of
use could meet the WCPP requirements. Additionally, industrial and
commercial use of methylene chloride as a laboratory chemical is
necessary to provide for the analysis of monitoring samples required to
demonstrate compliance with the WCPP under this proposed regulation.
An additional candidate for the WCPP is paint and coating removal
from safety-critical, corrosion-sensitive components on military and
Federal aviation. Regarding military aviation, as part of interagency
collaboration with the DOD on the NPRM issued in January 2017 (Ref.
47), EPA was made aware that there are specific military uses for which
methylene chloride is essential for paint and coating removal for which
there are no suitable alternatives currently available (see further
discussion in Unit V.B.). These consist of the use of methylene
chloride for the removal of coatings from corrosion-sensitive
components on military aviation, including safety-critical components
made of specialty metallic, nonmetallic, and composite materials. More
specifically, this includes components such as landing gear, gear
boxes, turbine engine parts, and other military aircraft components
composed of metallic materials (specifically high-strength steel,
aluminum, titanium, and magnesium) and composite materials that require
their coatings be removed for inspection and maintenance. Similarly, as
stated by commenters on EPA's 2017 NPRM (Ref. 38), aircraft and other
assets operated by DHS, NASA, and the FAA also contain safety-critical,
corrosion-sensitive components of the type described by DOD, and
suitable alternatives to methylene chloride are similarly not available
for all applications.
As described further in Unit V.B., EPA concluded that under TSCA
section 6(c)(2)(C) that technologically and economically feasible
alternatives that benefit health or the environment would not be
readily available as a substitute for these specific safety-critical
uses on corrosion-sensitive components. However, under TSCA section
6(a), EPA must still address identified risks such that they are no
longer unreasonable. EPA considered the appropriateness of the WCPP for
this subset of activities under industrial or commercial use of
methylene chloride for commercial paint and coating removal, and
emphasizes that this consideration was made very narrowly for the use
of methylene chloride for paint and coating removal for safety-
critical, corrosion-sensitive components, and not for more general use
of methylene chloride in paint and coating removal by Federal agencies
or their contractors, or for aircraft or spacecraft paint and coating
removal more broadly. Rather, EPA's consideration of the
appropriateness of the WCPP takes into account the specifics of the
components from which the coatings are being removed (and thus the lack
of suitable alternatives for this particular subset of uses), and the
relevant paint and coating removal processes. EPA notes that these
activities are expected to take place in highly industrialized
facilities in which regulated areas may already be established, for
compliance with current regulations for methylene chloride or other
chemicals, and that the paint and coating removal work in these
facilities would not take place in small or enclosed spaces (rather,
parts would frequently be removed for coating removal) (Ref. 48).
Additionally, EPA considered whether exposures could feasibly be
reduced sufficiently so that the risks were no longer unreasonable. To
that end, during the risk evaluation for methylene chloride, DOD
submitted additional monitoring data for their particular activities
involving use of methylene chloride for paint and coating removal.
EPA's risk evaluation shows that, in comparison with other uses of
methylene chloride for paint and coating removal, the magnitude of
exposure, and thus the risks, are much lower for DOD's specified use.
More specifically, EPA's risk evaluation found that central tendency
risks for DOD uses of methylene chloride for commercial
[[Page 28320]]
paint and coating removal do not exceed the acute or chronic non-cancer
inhalation benchmarks, and high-end risks for those same endpoints
could be addressed using the minimum allowable PPE for methylene
chloride (Ref. 1). In addition to exposure reductions, EPA also
considered whether other components of the WCPP could be effectively
implemented, including development of exposure reduction plans,
exposure monitoring, administrative controls, and workplace
participation. During the development of this proposed rulemaking,
discussions with DOD confirmed what was suggested by EPA's risk
evaluation--that is, the remaining uses by DOD and other Federal
agencies (e.g., DHS, NASA, and FAA) of methylene chloride for paint and
coating removal for safety-critical, corrosion-sensitive components are
highly industrialized and take place in controlled settings with
numerous protections for workers already in place. In this way, use of
methylene chloride for the removal of coatings from corrosion-sensitive
components on military aviation, including safety-critical components
made of specialty metallic, nonmetallic, and composite materials
resembles other uses of methylene chloride for which the WCPP is being
proposed, such as laboratory use. EPA further expects that Federal and
Federal contractor facilities are subject to multiple levels of
oversight as a result of the governmental and public nature of their
activities, while civilian aviation facilities are not likely to
experience the same level of scrutiny. Federal Government procurement
is also subject to the Federal Acquisition Regulations System in Title
49 of the CFR, which prescribes, among other things, health and
environmental management and oversight requirements for Federal
contracts. For this reason, EPA is proposing a WCPP for this particular
subset of the methylene chloride commercial paint and coating remover
condition of use. EPA requests comment and further information
regarding the Agency's expectations that Federal and Federal contractor
facilities would be subject to a higher level of oversight than non-
Federal or contractor facilities, and that existing or expected
controls would be successful in achieving the requirements of the WCPP.
Similarly, EPA has examined the use of methylene chloride as a
bonding agent for acrylic and polycarbonate in mission-critical
military and space vehicle applications by Federal agencies and their
contractors (Ref. 43) and is proposing WCPP for this subset of the
commercial use of methylene chloride in adhesives condition of use.
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 sealing
the plastic cases of specialty batteries.
A stakeholder that produces lithium and silver oxide zinc batteries
described how they are used in critical energy storage applications in
military and space exploration settings, including defense applications
such as precision guided weapons, military airframes, satellites, space
launch vehicles, and spacecraft. (The stakeholder also described use of
these batteries in medical devices; EPA notes that the TSCA definition
of ``chemical substance'' excludes, under TSCA section 3(2)(B)(vi),
``any food, food additive, drug, cosmetic, or device . . . when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.'' 15 U.S.C. 2602(2)(B)(vi).
To the extent that bonding agents in the production of specialty
batteries for medical applications qualify as a ``device'' as defined
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, those
particular uses that qualify as a ``device'' would be excluded from the
``chemical substance'' definition if ``manufactured, processed, or
distributed in commerce for use as a . . . device,'' and would
therefore not be subject to the rule if finalized). This stakeholder
requested an exemption under TSCA section 6(g) for this use of
methylene chloride. According to the requester, all major military and
space applications, such as aircraft (F-35, B2), radios, and Mars
mission equipment, require these batteries to function in very harsh
conditions, including operation to -40 [deg]C and storage at -54
[deg]C.
Methylene chloride is used as a bonding agent for assembly of the
plastic casings for these specialty batteries. The requester views the
casing as a critical component of the battery because it houses and
protects the cell anodes and cathodes. The requester explains that,
during the solvent bonding process, methylene chloride dissolves the
plastic slightly, allowing the polymers to form a physical bond
comprised of the parent material. This results in a fully bonded
battery casing which acts as a single Unit, rather than individual
pieces integrated with layers of a different material. According to the
requester, methylene chloride is a superior bonding agent for this
process because of its unique evaporative qualities. In the requester's
view, methylene chloride's low evaporation rate results in a higher
degree of polymer bonding and a stronger casing, with less residue to
inhibit the bonding process. The requester is not aware of any
substance other than methylene chloride that would enable the
production of battery casings of sufficient strength and durability for
these specialty batteries. The requester further contends that the
governmental and other entities for whom the requester produces these
batteries prevent the substitution for methylene chloride in their
contract specifications.
EPA's consideration of the lack of availability of technologically
and economically feasible alternatives, pursuant to TSCA section
6(c)(2)(C), was one factor in the proposed determination not to
prohibit manufacture, processing, distribution in commerce, and use of
methylene chloride as a bonding agent for acrylic and polycarbonate in
mission critical military and space vehicle applications, such as in
the production of specialty batteries for use in such applications
(Ref. 48) (discussed further in Unit V.B.). However, under TSCA section
6(a), EPA must still address identified risks such that they are no
longer unreasonable. Based on information provided by NASA and the
vendor, EPA determined that the production of these specialty batteries
necessarily occurs in a highly industrialized and well-controlled
environment, which EPA does not expect to be replicated for most uses
of methylene chloride in general use adhesives. Such a highly
industrialized and well-controlled environment would allow for
establishment of a regulated area and effective monitoring.
Additionally, EPA expects that, for this specific use, facilities would
be able to successfully implement the WCPP, including exposure
reduction to levels below which the unreasonable risk would not be
present due primarily to the small quantities of methylene chloride
used, as well as to the engineering and other controls in place. For
example, in the vendor's process, ``methylene chloride is a component
of the bonding cement that is moved through an entirely closed tubing
system into a vented reservoir and vented enclosure for bonding and
curing'' (Ref. 48). In this way, use of methylene chloride as a bonding
agent in specialty batteries resembles other uses of methylene chloride
for which the WCPP is being proposed such as laboratory use and paint
and coating
[[Page 28321]]
removal by Federal agencies on safety-critical, corrosion-sensitive
aircraft components. For this reason, EPA is proposing a WCPP for this
particular subset of the methylene chloride commercial use in adhesives
condition of use. EPA requests comment and further information
regarding the Agency's expectations that the facilities in which this
use is carried out are industrialized and highly controlled, and that
existing or expected exposure reduction and workplace controls would be
successful in achieving the requirements of the WCPP. EPA also notes
that while the Agency is not aware of any similar use of methylene
chloride as a bonding element for batteries for commercial spaceflight
or other use, it requests comment and information on any such use.
For methylene chloride to be available for processing as a reactant
and industrial and commercial use as a laboratory chemical, it must be
manufactured (including imported), processed, and distributed in
commerce. Likewise, as long as methylene chloride remains in use, it
must also be disposed of. The manufacturing, processing, and disposal
conditions of use for methylene chloride include, to some extent, the
factors described earlier in this Unit favor the successful
implementation of the WCPP (e.g., they do not take place in the field
(i.e., they do not take place outside of a highly controlled
environment) and are highly industrialized). Regulating upstream
manufacturing and processing of methylene chloride is a key component
of the supply-chain approach for risk management of commercial and
consumer use of methylene chloride. Therefore, as discussed in Unit
IV.A.1., EPA is proposing the WCPP for manufacture (including
importing) and processing for certain uses, and disposal to ensure that
workers are not subject to the unreasonable risk from methylene
chloride as it moves throughout the supply chain.
Additionally, for methylene chloride, the strong precedent for
dermal protection set by 29 CFR 1910.1052, in combination with the risk
characterization in the 2020 Risk Evaluation for Methylene Chloride
which indicated chemically resistant gloves, together with activity
specific training are sufficient to address the unreasonable risk, led
EPA to propose a dermal PPE requirement as part of the WCPP (Ref. 1).
As discussed in the Economic Analysis, there is some uncertainty
relative to the burden of recycling and disposal facilities that would
be required to implement a WCPP under this proposed regulation,
particularly in implementing an air monitoring program. For example,
disposal facilities may be receiving methylene chloride intermittently;
however, facilities that currently receive methylene chloride-
containing products or formulations for disposal may not receive
methylene chloride in the future, as restrictions are finalized. As
many of these facilities are small entities, EPA is requesting comment
on what regulatory flexibilities (e.g., extended compliance) may be
afforded to entities that would continue to recycle and dispose of
methylene chloride under the proposed regulation.
2. Prohibition
Because both EPA's 8-hour ECEL and 15-minute EPA STEL are
significantly lower than the OSHA PEL and STEL, there is a high degree
of uncertainty as to whether most industrial and commercial users will
be able to comply with such a level and thus whether the unreasonable
risk would be addressed. As discussed earlier in this Unit, this
uncertainty, combined with the severity of the risks of methylene
chloride and the prevalence of cost-effective alternative processes and
products (Ref. 3), has led EPA to propose prohibitions, rather than
compliance with the WCPP, for most industrial and commercial uses of
methylene chloride, as outlined in Unit IV.A.2.
EPA also considered the potential for methylene chloride use to
increase in particular sectors, such as vapor degreasing applications,
where it has largely been phased out because of the well-established
hazard (Refs. 3, 49). In order to prevent the potential for use of
methylene chloride to increase in a sector that has already moved away
from it, use of methylene chloride in vapor degreasing would be
prohibited under the proposed regulatory and primary alternative
regulatory action. The decline in use of methylene chloride was one of
several considerations that led EPA to propose to prohibit use of
methylene chloride in vapor degreasing.
Regarding industrial, commercial, and consumer uses of methylene
chloride, TSCA section 6(a)(2) provides EPA with the authority to
prohibit or otherwise restrict the manufacture (including import),
processing, or distribution in commerce of a substance or mixture ``for
a particular use'' to ensure that a chemical substance no longer
presents unreasonable risk. For this rule, EPA proposes that ``for a
particular use'' includes consumer use more broadly, as well as
industrial and commercial use, which encompasses the individual
industrial, commercial, and consumer uses evaluated in the 2020 Risk
Evaluation for Methylene Chloride. Given the severity and ubiquitous
nature of the risks identified in the 2020 Risk Evaluation for
Methylene Chloride for all industrial, commercial, and consumer use,
and noting that those conditions of use encompass all known, intended,
and reasonably foreseen use of methylene chloride (other than 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)), EPA proposes that prohibiting manufacture (including
importing), processing, and distribution in commerce of methylene
chloride for most industrial and commercial use and all consumer use is
reasonable and necessary to eliminate the unreasonable risk of
methylene chloride from industrial, commercial, and consumer use,
including by precluding retailers from selling methylene chloride and
methylene chloride-containing products to consumers for unspecified
end-uses. (The proposed prohibitions would not extend to the use of
methylene chloride in consumer paint and coating removers since
manufacturing, processing, and distribution for that use are already
prohibited.) EPA believes that any retailer selling methylene chloride-
containing products to consumers for unspecified end-uses would be
selling products for use by consumers for one of the consumer uses EPA
evaluated in the 2020 Risk Evaluation for Methylene Chloride and found
to drive the unreasonable risk for methylene chloride in the 2022
revised risk determination. EPA's proposed requirements to address
unreasonable risk to consumers and bystanders to consumer use are
described in Unit IV.A.
A key consideration regarding consumer uses is the role of
retailers and other distributors. A retailer is defined in 40 CFR
751.103 as any entity that makes available a chemical substance or
mixture to consumer end users, including through e-commerce internet
sales or distribution, and is not specific to retailers of methylene
chloride. Previously, in the 2019 methylene chloride TSCA section 6(a)
risk management rulemaking addressing consumer use of methylene
chloride in paint and coating removal (Ref. 37), EPA prohibited (see 40
CFR 751.105(c)) retailers from distributing in commerce paint and
coating removers containing methylene chloride, as well as distribution
to retailers under 40 CFR 751.105(b) (Ref. 37). To meet the same
[[Page 28322]]
goal of protecting consumers from accessing methylene chloride-
containing products that could pose unreasonable risk, for a broader
range of consumer use, EPA considered using a similar provision to
ensure that retailers will not be able to purchase methylene chloride
for sale or distribution to consumers, or to make available to
consumers products containing methylene chloride. This provision aims
to help prevent the use of methylene chloride in non-industrial
settings or for off-label uses by consumers. For these reasons, as
described in Unit IV.A.3., EPA's proposal to address unreasonable risk
from methylene chloride includes prohibition on the distribution in
commerce of methylene chloride to and by retailers.
3. Primary Alternative Regulatory Option
EPA acknowledges that for some of the occupational uses that it is
proposing to prohibit, there may be some activities or facilities that
could implement workplace protection requirements necessary to ensure
that exposure remain below the ECEL and EPA STEL. In some cases, they
may be able to undertake more extensive risk reduction measures than
EPA currently anticipates. Therefore, for EPA's primary alternative
regulatory action described in Unit IV.B., EPA is considering and
requesting comment on a WCPP, including requirements to ensure
exposures remain below an ECEL and EPA STEL, for some conditions of use
of methylene chloride in addition to those conditions of use which are
proposed to be subject to a WCPP under the proposed regulatory action
(i.e., those additional uses listed in Unit IV.B.). This includes
conditions of use that have not resulted in documented acute
fatalities, where reasonably available information suggests minimal
ongoing use, where reasonably available information suggests use of
methylene chloride may increase if other solvents are significantly
restricted for that use such as for other solvents undergoing risk
evaluation under TSCA section 6(b), and where the regulated entities
may have fewer challenges implementing requirements to meet an ECEL and
EPA STEL because work activities may occur in sophisticated facilities
or take place in a closed system. The additional conditions of use
which would be subject to WCPP under the primary alternative regulatory
action described in this notice meet all of these criteria. However,
EPA was not able to identify reasonably available information such as
monitoring data or detailed activity descriptions to indicate with
certainty that relevant regulated entities for these conditions of use
could sufficiently mitigate identified unreasonable risk through a
WCPP. Due to this uncertainty, EPA is requesting comment on the ways in
which methylene chloride may be used in the additional conditions of
use that would be subject to a WCPP under the primary alternative
regulatory action, and the degree to which users of methylene chloride
in these sectors could successfully implement the WCPP, including
requirements to meet an ECEL and EPA STEL, as described in Unit
IV.A.1., for the conditions of use listed for the primary alternative
regulatory action in Unit IV.B.
Additionally, As discussed in Unit V.A.1. and 2., EPA acknowledges
that for the occupational uses for which it is proposing the WCPP,
there are varying degrees of uncertainty as to whether industrial and
commercial owners and operators are able implement workplace protection
requirements necessary to ensure that exposures remain below the ECEL
and EPA STEL. For this reason, EPA's alternative regulatory action
would prohibit two uses for which EPA is proposing the WCPP (industrial
or commercial use for paint and coating removal from safety-critical,
corrosion-sensitive components of aircraft and spacecraft by Federal
agencies and their contractors; and industrial or commercial use as a
bonding agent in the production of specialty batteries for military or
space applications by Federal agencies and their contractors). Because
of the importance of these uses for national security and critical
infrastructure, EPA's alternative regulatory action would include a
time-limited exemption under TSCA section 6(g) from the prohibition for
these two uses, for a period of 10 years, during which time the
regulated entity would comply with a WCPP to the extent practicable.
The analyses for these exemptions are in Unit IV.B.
4. Risk Management Requirements Considered but Not Proposed
Since it is unlikely that all facilities with occupational
exposures to methylene chloride would be able to implement a WCPP,
including requirements to meet an ECEL and EPA STEL, EPA also examined
the extent to which a certification and limited access program
restricting methylene chloride use to trained and licensed users could
ensure that only certain workers employed by a facility would be able
to purchase and subsequently use methylene chloride. Under a limited
access program, entities would submit a self-certification to the
distributor at the point of purchasing the products. The self-
certification could consist of a statement indicating that the facility
is implementing a WCPP to control exposures to methylene chloride, as
well as a connection between the purchaser and the facility (e.g., a
current employee). As discussed earlier in this Unit, because of the
severity of acute risks from methylene chloride which could potentially
lead to fatalities, and the high potential for diversion of commercial
products of methylene chloride for non-commercial use, EPA has
significant concerns regarding the appropriateness of a certification
and limited access program for methylene chloride. These concerns are
supported by previous comments received as part of public comments on
the Advance Notice of Proposed Rulemaking for Methylene Chloride
Commercial Paint and Coating Removal: Training, Certification and
Limited Access Program expressing unease in implementing a training,
certification and limited access program for methylene chloride (Ref.
50).
Several commenters on the Advance Notice of Proposed Rulemaking for
Methylene Chloride Commercial Paint and Coating Removal: Training,
Certification and Limited Access Program identified what they believe
would be insufficiencies in training, certification, and limited access
to methylene chloride (Ref. 50). Commenters expressed concerns that
this type of program would not provide enough safeguards and would not
eliminate unreasonable risk to workers. Commenters were skeptical of a
training program's efficacy noting that deaths related to methylene
chloride exposure still occurred with workers who were trained and
wearing PPE (Ref. 50).
Several commenters believed that a training, certification, and
limited access program would not be feasible. A commenter suggested
that an effective training model to examine is the Alaska Hazardous
Paint Certification program, which includes hands-on training and
practice in local exhaust ventilation techniques and equipment and PPE
gloves, clothing, and respirators. In the Alaskan program, a minimum of
16 hours for initial training, with at least 6 hours of hands-on
training as well as 8-hour refresher class every 3 years, are necessary
requirements. Moreover, commenters expressed that a robust training,
certification, and limited access program would include multiple layers
of training and certification and supporting documentation. A commenter
also highlighted that ``small businesses do not have the same resources
for implementing safety
[[Page 28323]]
programs as larger ones, yet they account for a very large percentage
of [methylene chloride] users.'' In light of these comments, EPA
decided to account for uncertainty related to ECEL implementation and
compliance for certain uses by proposing prohibitions on those uses,
rather than proposing a self-certification and limited access program.
Nonetheless, EPA is requesting comment on the inclusion of a
certification, training, and limited access program for any uses that
would be subject to a WCPP, in addition to the requirements outlined in
Unit IV.A.1.
Another option that EPA considered for occupational conditions of
use was requiring specific, prescribed engineering controls,
administrative controls, or PPE to reduce exposures to methylene
chloride in occupational settings. These prescriptive requirements
would be supported by information in the 2020 Risk Evaluation for
Methylene Chloride. As described in Units III.A.1. and 2., EPA received
input during required consultations and additional engagement that
options that align with the hierarchy of controls (i.e., elimination
and substitution of hazards in the workplace), which could be
accomplished through the implementation of a WCPP with a risk-based
exposure limit, should be preferred over prescriptive controls (Refs.
9, 51). Inadequacy of engineering, administrative, and PPE control
measures to lower exposure below the exposure limit would mean that
elimination or substitution would be the only viable methods of
addressing unreasonable risk, creating in effect a de-facto
prohibition. Additionally, prescriptive controls present significant
uncertainties related to their feasibility and consistency of proper
use.
EPA determined that such prescriptive controls (i.e., engineering
or administrative controls, or PPE) may not be able to eliminate
unreasonable risk for some conditions of use when used in isolation. In
the 2020 Risk Evaluation for Methylene Chloride, many conditions of use
still drive the unreasonable risk even with the application of air-
supplied APF 50 respirators (Ref. 1). Additionally, where data were
reasonably available, EPA modeled the change in air rates that would be
needed to eliminate unreasonable risk and found that in some cases it
was not possible to eliminate unreasonable risk with changes in airflow
alone, while in other cases the change in airflow needed would not be
feasible to achieve (Ref. 1). Because of the uncertainty regarding the
feasibility of exposure reductions through prescriptive controls alone,
EPA determined that a WCPP, including requirements to meet an ECEL and
EPA STEL (which would be accompanied by monitoring requirements) in
tandem with the implementation of engineering controls, administrative
controls, and/or PPE as elements of the program, as appropriate, would
more successfully reduce exposure so that the unreasonable risk is
addressed. For occupational conditions of use where compliance with the
WCPP is unlikely to eliminate the unreasonable risk driven by those
conditions of use, prohibitions (rather than prescribed controls) would
be more appropriate to ensure that methylene chloride does not present
unreasonable risk under the conditions of use.
EPA also considered limiting the weight fraction of methylene
chloride in consumer products and conducted an analysis using the
Consumer Exposure Models for the 2020 Risk Evaluation for Methylene
Chloride to estimate whether this would reduce risks from consumer
conditions of use that drive the unreasonable risk for methylene
chloride, such that they no longer drive the unreasonable risk (Ref.
52). For all consumer conditions of use, the weight fraction or
concentration identified through this modeling that would address the
unreasonable risk through inhalation or dermal pathways was so low that
it was highly unlikely that methylene chloride would still serve its
functional purpose in the formulation. EPA thus concluded that a weight
fraction limit would essentially function as a prohibition yet with a
greater amount of uncertainty regarding compliance and no increased
benefit to consumer users; it was therefore not a preferred option for
consumer uses. (Refs. 1, 52).
5. Additional Considerations
After considering the different regulatory options under TSCA
section 6(a), alternatives (described in Unit III.B.4.), compliance
dates, and other requirements under TSCA section 6(c), EPA developed
the proposed regulatory action described in Unit IV.A. to address the
unreasonable risk from methylene chloride. To ensure successful
implementation of this proposed regulatory action, EPA considered other
requirements to support compliance with the proposed regulations, such
as requiring monitoring and recordkeeping to demonstrate compliance
with the WCPP, or downstream notification regarding the prohibition on
manufacturing, processing, and distribution in commerce of methylene
chloride, and products containing methylene chloride, for consumer use.
These proposed requirements are described in Unit IV.A.
Under TSCA section 6(g)(1)(B), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if compliance with the requirement
would significantly disrupt the national economy, national security, or
critical infrastructure. Based on reasonably available information, EPA
has found that a TSCA section 6(g) exemption is warranted for certain
uses. Therefore, EPA is proposing to grant exemptions from the rule
requirements under TSCA section 6(g), as detailed in Unit IV.A.5. Unit
IV.A.5. also provides a description of the request for exemption from
the rule requirements that EPA is not proposing to grant. TSCA section
6(g) assumes a particular use cannot continue such that the risks are
no longer unreasonable. However, EPA notes that information may be
provided during the public comment period indicating this may not be
case. For example, new information may demonstrate compliance with a
WCPP is possible.
As required under TSCA section 6(d), any rule under TSCA section
6(a) must specify mandatory compliance dates, which shall be as soon as
practicable with a reasonable transition period, but no later than 5
years after the date of promulgation of the final rule (except in the
case of a use exempted under TSCA section 6(g)). For ban or phase-out
requirements, EPA must specify mandatory compliance dates for the start
of ban or phase-out requirements, which must be as soon as practicable
but no later than 5 years after the date of promulgation of the final
rule (except in the case of a use exempted under TSCA section 6(g)),
and for full implementation of ban or phase-out requirements, which
must be as soon as practicable. These compliance dates are detailed in
Unit IV.A. and IV.B.
B. Consideration of Alternatives in Deciding Whether To Prohibit or
Substantially Restrict Methylene Chloride
Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or
restrict in a manner that substantially prevents a specific condition
of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must consider, to
the extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use so proposed to be prohibited or restricted,
[[Page 28324]]
will be reasonably available as a substitute when the proposed
prohibition or other restriction takes effect. To that end, in addition
to an Economic Analysis (Ref. 3), EPA conducted an Alternatives
Assessment, using reasonably available information (Ref. 40).
For this assessment, EPA identified and analyzed alternatives to
methylene chloride in products relevant to industrial, commercial, and
consumer conditions of use proposed to be prohibited or restricted,
even if such restrictions are not anticipated to substantially prevent
the condition of use. EPA is aware of the lack of viable alternatives
to methylene chloride for several conditions of use and considered that
information to the extent practicable in the development of the
regulatory options as described in Unit III.B.3.
As an example, EPA's consideration of the lack of viable
alternatives to processing methylene chloride in the manufacture of
HFC-32 taken in context with the risk estimates, monitoring data, and
expected work practices informed EPA's proposed approach of WCPP for
this condition of use. Similarly, when proposing WCPP for industrial or
commercial use of methylene chloride for paint and coating removal from
mission- and safety-critical, corrosion sensitive components of
aircraft and spacecraft by Federal agencies or their contractors, EPA
considered how the safety-critical, corrosion-sensitive components
would be so negatively affected by the use of technically incompatible,
substitute paint removal chemicals or methods that the safe performance
of the aircraft could be compromised. There are no known substitutes
for methylene chloride for this particular use. As discussed in the
preamble to the 2017 NPRM, DOD has actively sought to reduce its use of
methylene chloride in paint and coating removal since 1990. DOD has
replaced most of its usage of methylene chloride for paint and coating
removal with mechanical methods, benzyl alcohol products, other
solvents, and laser ablation. In an effort to reduce the use of all
hazardous air pollutants (HAPs) such as methylene chloride, the Army
has conducted tests to identify and test the effectiveness of HAP-free
paint and coating removers on military high-performance coatings (Ref.
53). In another example, the Air Force in December 2015 significantly
reduced the use of methylene chloride for removing coatings on flight
control parts and is now using substitute chemical products, primarily
those with benzyl alcohol formulations (Ref. 48). Similarly, the Navy
has transitioned substitutes to paint methylene chloride use when
alternatives with equal performance are identified. For DOD, this
evaluation of and transition to safer alternatives is ongoing and
substitutions are approved where technically feasible and commensurate
with performance and mission-readiness requirements.
DOD continues to pursue potential substitutes for methylene
chloride. However, for safety-critical, corrosion-sensitive components
on military aviation, including safety-critical components, DOD has
found that currently available substitute chemicals for paint and
coating removal have one or more technical limitations. These include
the inability to effectively remove specific military high performance
or chemical resistant coatings and incompatibility with underlying
metallic, nonmetallic, and composite materials, resulting in material
damage to critical components. In addition, substitute chemicals or
methods currently available do not support DOD's need for coating
removers that enable critical safety inspection, non-destructive
inspection, material assessment, or field repair processes. For
example, benzyl alcohol has replaced methylene chloride in many DOD
paint and coating removal applications. However, acid benzyl alcohol
formulations, which work more quickly than alkaline formulations,
cannot be used on high-strength steel or magnesium metals because there
is the potential for resulting hydrogen embrittlement (Ref. 54). In
DOD's experience, the alkaline benzyl alcohol formulations require 25
to 50% more time than methylene chloride and are more labor-intensive,
particularly on very thick coatings or polyurethane coatings with
water-based primers (Ref. 54). In addition, the reaction rate for
alkaline benzyl alcohol formulations is very slow when the temperature
is below 65 degrees, so paint and coating removal in cold locations
with this alternative must be performed in a heated area (Ref. 54). As
described earlier in Unit V.A.1., aircraft and other assets operated by
DHS, NASA, and the FAA also contain safety-critical, corrosion-
sensitive components of the type described by DOD, and suitable
alternatives to methylene chloride are similarly not available for all
applications. Substitute chemicals for paint and coating removal for
safety-critical, corrosion-sensitive components are not technically
feasible as they have one or more technical limitations; are
incompatible with underlying materials; and/or do not support the
coating removal requirements of safety inspections, non-destructive
inspection, material assessment, or field repair processes. Therefore,
EPA has evaluated the effect that a significant restriction on the use
of methylene chloride would have for industrial and commercial paint
and coating removal by DOD, DHS, NASA, and FAA and concluded that under
TSCA section 6(c)(2)(C) that technologically and economically feasible
alternatives that benefit health or the environment would not be
readily available as a substitute. Due to the essential nature of this
subset of activities under industrial or commercial use of methylene
chloride as a paint and coating remover, EPA's consideration of the
availability of technologically and economically feasible alternative
was one factor in the proposed determination not to prohibit
manufacture, processing, distribution in commerce, and use of methylene
chloride for paint and coating removal for safety-critical, corrosion
sensitive components.
As an additional example, EPA considered the information provided
regarding a lack of viable alternatives for the use of methylene
chloride in chemical bonding of acrylic and polycarbonate, specifically
for specialty batteries for use in military and space applications. As
described earlier in Unit V.A., EPA received information from a
stakeholder, as part of a request for an exemption under TSCA section
6(g), describing how methylene chloride is uniquely suited as a bonding
agent for these specialty batteries. Upon receipt of the TSCA section
6(g) exemption request summarized in this unit, EPA consulted with
NASA, and NASA provided information on its effort to screen alternative
adhesives for the chemical bonding of acrylic and polycarbonate.
Specifically, NASA identified ten materials and completed screening-
level testing for six of those ten materials as of the publication of
this proposed rule. Results submitted to EPA indicate that none of the
materials tested met the technical requirements for chemical bonding
applications (Ref. 47). While vendors submitting the TSCA section 6(g)
exemption request predicted a timeline of at least one year to find a
replacement for the bonding agent for specialty batteries, NASA noted
that the projected substitution timeline applies only to the vendor's
own battery production process. The total timeline, including
qualification testing for human spaceflight, is a complex, multi-year
process that could only begin after the vendor's substitution was
completed.
[[Page 28325]]
NASA additionally emphasized that losing access to qualified high-
performance substances such as specialty batteries would have immediate
effects for currently ongoing space-flight programs, including the
Artemis Program, with the potential to introduce an unacceptable level
of risk to crew, vehicle, and viability of the program. Qualification
of materials for human spaceflight can take years and significant
resources to accomplish, while potentially impacting program production
schedule and launch manifest.
NASA has emphasized that specific Artemis components have been
designed to work with the identified specialty batteries with
polycarbonate casing bonded using methylene chloride. The safety and
reliability of these batteries has been established in uncrewed Artemis
I test missions, and the next flights will take humans back to the
Moon. A change of battery material would require recertification of
multiple hardware pieces, retesting of crew and vehicle safety, and
disrupt parts production and launch schedules that are already
underway. NASA notes that stockpiling of batteries would not be an
option, as batteries have a 2-year shelf life.
For this use, EPA has concluded under TSCA section 6(c)(2)(C) that
technologically and economically feasible alternatives that benefit
health or the environment would not be readily available as a
substitute. Due to the essential nature of this subset of activities
under industrial or commercial use of methylene chloride as an
adhesive, a paint and coating remover, EPA's consideration of the
availability of technologically and economically feasible alternative
was one factor in the proposed determination not to prohibit
manufacture, processing, distribution in commerce, and use of methylene
chloride as a bonding agent in the production of specialty batteries
for use in military and space applications.
EPA also notes that, for some conditions of use, EPA was unable to
identify products currently available for sale that contain methylene
chloride. EPA is soliciting comments on whether there are actually
products in use or available for sale relevant to these conditions of
use that contain methylene chloride at this time, so that EPA can
ascertain whether there are alternatives that benefit human health or
the environment. These conditions of use are detailed in the
Alternatives Assessment (Ref. 40).
For conditions of use for which products currently containing
methylene chloride were identified, EPA identified several hundred
commercially available alternative products that do not contain
methylene chloride, and listed in the Alternatives Assessment, to the
extent practicable, their unique chemical components, or ingredients.
For each of these chemical components or ingredients, EPA identified
whether it functionally replaced methylene chloride for the product use
and screened product ingredients for human health and environmental
hazard, as well as identified flammability and global warming potential
where information was reasonably available (Ref. 40). EPA then assigned
a rating to the human health and environmental hazards, using a
methodology described in the Alternatives Assessment document. EPA
identified 65 total alternative products in the paint and coating
remover category, of which furniture refinishing is a subcategory (Ref.
48). As described in the Economic Analysis, while not all of these
alternative products may meet the specific use for some furniture
refinishing uses, mechanical or thermal methods may be non-chemical
alternatives to using products containing methylene chloride for paint
and coating removal. EPA did not find barriers to pricing, customer
satisfaction, coating removal performance, or content (specifically
volatile organic compounds, or VOC) that may be caused by restricting
the use of methylene chloride in this product category in general. For
fire safety, the restriction of methylene chloride in this product
category is met by products with very high flash points, or products
with evaporation barriers that restrict vapor generation (Ref. 3).
Therefore, EPA finds that there are technological and economically
feasible alternatives in the marketplace.
In general, EPA identified products containing ingredients with a
lower hazard screening rating than methylene chloride for certain
endpoints, while some ingredients presented higher hazard screening
ratings than methylene chloride (Ref. 40). These alternative hazard
screening ratings are described in detail in the Alternatives
Assessment grouped under common product use categories (Ref. 40). EPA
has therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the
extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other
restriction becomes effective. EPA is additionally requesting comment
on the alternatives analysis as a whole.
VI. 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, 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
[[Page 28326]]
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 drive 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). As mentioned in Unit II.D.,
EPA has separately conducted a screening approach to assess whether
there may be risks to the general population from these exposure
pathways. While the use of this screening approach indicates some level
of risk to fenceline communities, EPA cannot determine, without further
data and quantitative analysis, whether the risk to these communities
would be an unreasonable risk. This Unit summarizes the results of that
fenceline analysis. Although EPA is not making a determination of
unreasonable risk based on the fenceline screening analysis, the
proposed regulatory action described in Unit IV. is expected to reduce
the risks identified in the screening approach.
As described in Unit II.D., EPA's analysis was presented to the
SACC peer review panel in March 2022, and EPA plans to consider SACC
feedback (including the SACC recommendation to EPA to consider multiple
years of release data to estimate exposures and associated risks) and
make decisions regarding how to assess general population exposures in
upcoming risk evaluations, such as for 1,4-dioxane and for the
forthcoming 20 High Priority Substances. For methylene chloride, EPA
recognizes that a key input into the fenceline assessment was data on
releases from the most recent Toxics Release Inventory (TRI) reporting
year and that the use of more than one year of data could result in
different conclusions. Accordingly, in this Unit EPA presents the
results of its analysis of the extent to which including more than one
year of TRI data impacts EPA's conclusions regarding fenceline risks
(Ref. 55).
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.
Additionally, EPA's analysis, as presented to the SACC, identified
14 facilities, representing nine conditions of use, with some
indication of expected exposure and associated cancer risk to receptors
within select distances evaluated from 5 to 100 meters from the
inhalation pathway. Those nine conditions of use are: industrial and
commercial use in non-aerosol degreasers and cleaners; industrial and
commercial use as a solvent for in-line vapor degreasing; industrial
and commercial use as a solvent for cold cleaning; industrial and
commercial use in aerosol spray degreasers and cleaners; industrial and
commercial use in cellulose triacetate film production; industrial and
commercial use in plastic and rubber product manufacturing; processing:
incorporation into a formulation, mixture, or reaction product;
industrial and commercial use as a propellant and blowing agent; and
industrial and commercial use in paint and coating removers. Under the
proposed regulatory action described in Unit IV.A., all of the
conditions of use with an indication of risk from 5 to 100 meters would
be prohibited, with the exception of processing: incorporation into a
formulation, mixture, or reaction product.
Of those 14 facilities with indicated risk, only three had an
indication of risk out to 100 meters from a releasing facility. Those
three facilities represent three total conditions of use: industrial
and commercial use in non-aerosol degreasers and cleaners; industrial
and commercial use for plastic product manufacturing; and industrial
and commercial use as a propellant and blowing agent. Under the
proposed regulatory action described in Unit IV.A., these three
conditions of use, as well as all of the conditions of use with an
indication of risk at 5 to 100 meters would be prohibited, with the
exception of processing: incorporation into a formulation, mixture, or
reaction product.
Following SACC feedback, EPA applied a slightly modified pre-
screening methodology to evaluate 6 years of methylene chloride release
data (2015 through 2020 Toxic Release Inventory data as well as the 6-
year average of that data) for those 14 facilities where there was an
indication of exposure and associated risk via the ambient air pathway.
The multi-year analysis further supported EPA's findings (indications
of exposure and associated risks) from the original analysis for five
of the 14 facilities, representing four conditions of use, which
indicated exposure and associated risk at 100 meters from a releasing
facility. Those four conditions of use are: processing: incorporation
into a formulation, mixture, or reaction product; industrial and
commercial use in non-aerosol degreasers and cleaners; industrial and
commercial use for plastic product manufacturing; and industrial and
commercial use as a propellant and blowing agent. For the additional
nine facilities, the multi-year analysis did not indicate risks at 100
meters. The multi-year analysis incorporated 6 years of TRI data and
found that while the annual releases may vary by as much as a factor of
10, the overall estimated exposure concentrations and associated risk
calculations varied by no more than three times. Additionally, typical
cancer benchmarks used by EPA and other regulatory agencies are an
increased cancer risk above benchmarks ranging from 1 in 1,000,000 to 1
in 10,000 (i.e., 1 x 10-6 to 1 x 10-4), in some
cases depending on the subpopulation exposed. (see, e.g., EPA's
interpretation set forth in 54 FR 38044, September 14, 1989) which
discusses the use of benchmarks for purposes of section 112 of the
Clean Air Act (CAA); see also EPA's interpretation of the upper bound
of acceptable risk and the preferred benchmark described in the Letter
of Concern regarding EPA Complaint Nos. 01R-22-R6, 02R-22-R6, and 04R-
22-R6 see page 3 footnotes 5 and 6 and page 6 (Ref. 56)). In this
fenceline analysis for the ambient air pathway for methylene chloride,
estimates of risk to fenceline communities were calculated using 1 x
10-6 as the benchmark for cancer risk in fenceline
communities. While EPA is unable to determine, based on the screening
level fenceline analysis, whether risks to the general population drive
the unreasonable risk, as a matter of risk management policy EPA
considers the range of 1 x 10-6 to 1 x 10-4 as
the appropriate benchmark
[[Page 28327]]
for increased cancer risk for the general population, including
fenceline communities. It is preferable to have the air concentration
of methylene chloride result in an increased cancer risk closer to the
1 x 10-6 benchmark, with the 1 x 10-4 benchmark
generally representing the upper bound of acceptability for estimated
excess cancer risk. The benchmark value is not a bright line, and the
Agency considers a number of factors when determining unreasonable
risk, such as the endpoint under consideration, the reversibility of
effect, exposure-related considerations (e.g., duration, magnitude, or
frequency of exposure, or population exposed). Under the proposed
regulatory action described in Unit IV.A., all of the conditions of use
with an indication of risk at 100 meters would be prohibited, with the
exception of processing: incorporation into a formulation, mixture, or
reaction product.
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 receptors within the
general population at particular facilities, EPA is unable to formally
determine with this analysis whether those risks drive the unreasonable
risk. However, EPA believes that the prohibitions being proposed for
manufacturing (including importing), processing, and distribution in
commerce for 45 of 53 uses, including all consumer use and most
commercial use, would address the majority of exposures to the general
population. Of the 14 facilities which indicated some risk for
methylene chloride, under the proposed regulatory option, only 3 could
continue to use methylene chloride (all for processing: incorporation
into formulation, mixture, or reaction product), and thus exposures to
the fenceline at the remainder of those facilities would be addressed.
Under the proposed rule, only ten conditions of use would continue,
namely domestic manufacturing (for downstream uses that would continue
under the WCPP); import; processing as a reactant; processing:
incorporation into a formulation, mixture, or reaction product;
processing as repackaging; processing as recycling; industrial and
commercial use as a laboratory chemical; 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. Of those conditions of use, only processing: incorporation
into formulation, mixture, or reaction product has risk indicated at
the fenceline, and based on land use analysis, there do not appear to
be communities currently located at the fencelines (Ref. 57).
Additionally, over time this condition of use can reasonably be
expected to decline because, while processing into a formulation,
mixture, or reaction product would continue under a WCPP, all
downstream distribution and use of formulations, mixtures, or reaction
products (except for laboratory use and any time limited exemptions
that could be established under TSCA section 6(g)) would be prohibited.
For all ten conditions of use that would remain ongoing, the
proposed rule would require exposure controls via implementation of a
WCPP as described in Unit IV.A.1. In the instances where 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 believes this potential exposure would
be limited as a result of the existing National Emission Standards for
Hazardous Air Pollutants (NESHAPs) for methylene chloride for these
conditions of use under the CAA (applicable NESHAPs: 40 CFR part 63
subpart F, Synthetic Organic Chemical Manufacturing Industry; 40 CFR
part 63 subpart DD, Off-Site Waste and Recovery Operations; 40 CFR part
63 subpart VVV, Publicly Owned Treatment Works; and 40 CFR part 63
subpart VVVVVV, the NESHAP for Chemical Manufacturing Area Sources) and
that any exceedances are an enforcement issue. Thus, EPA's proposal to
prohibit manufacture, processing, and distribution in commerce of
methylene chloride for all consumer use and most industrial and
commercial use, and to prohibit 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 drive the
unreasonable risk.
For all conditions of use, the unreasonable risk determination is
not driven by exposures via water for acute and chronic exposures to
methylene chloride for amphibians, fish, and aquatic invertebrates. 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, indicated risk, 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
[[Page 28328]]
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
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 hydrofluorocarbon-32 (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. 8).
D. Reasonably Ascertainable Economic Consequences of the Proposed Rule
1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health.
The reasonably ascertainable economic consequences of this proposed
rule include several components, all of which are described in the
Economic Analysis for this proposed rule (Ref. 3). With respect to the
anticipated effects of this proposed rule on the national economy, EPA
considered the number of businesses and workers that would be affected
and the costs and benefits to those businesses and workers and did not
find that there would be an impact on the national economy (Ref. 3).
The economic impact of a regulation on the national economy becomes
measurable only if the economic impact of the regulation reaches 0.25%
to 0.5% of Gross Domestic Product (GDP) (Ref. 58). 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 $13.2 million annualized over 20
years at a 3% discount rate and $14.5 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 addition, EPA considered the employment impacts of this proposed
rule, and found that the direction of change in employment is
uncertain, but EPA expects the short-term and longer-term employment
effects to be small. To that end, EPA is requesting public comment on
short term and longer-term employment effects from this proposal.
Of the small businesses potentially impacted by this proposed rule,
98% (225,248 firms) are expected to have impacts of less than 1% to
their firm revenues (rounded metric), 0.1% (118 firms) are expected to
have impacts between 1 and 3% to their firm revenues (rounded metric),
and 0.03212.1% (4,905 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 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).
Thus, the estimated total impact of the rule on small businesses ranges
from $11.1 to $73.6 million (see section 7.11 of the Economic
Analysis). Commercial paint and coating removers are one product type
where for which methylene chloride is likely the most effective product
for many applications. In particular, alternatives to methylene
chloride paint and coating removers in commercial furniture refinishing
may not be as cost-effective for this use because they may take more
time to achieve the desired outcome or require alternate processes
affecting operations that present challenges for certain businesses.
The impact of a prohibition of methylene chloride for furniture
refinishing could result in the closure of an unknown number of
affected entities or business lines. As discussed in Unit I.E., closure
of affected furniture refinishing firms using methylene chloride
following this rulemaking has an upper bound for economic impacts of
$1.8 billion in total revenue, and $67 million in terms of the total
profit, under the assumption that all affected firms fully close due to
the restrictions on methylene chloride. A detailed discussion of
potential economic impacts as a result of varying percentages of
furniture refinishing firms closing is provided in the Economic
Analysis in section 7.11 (Ref. 3).
With respect to this proposed 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 proposed rule may increase demand for existing, as well
as development of additional, safer chemical substitutes. This proposed
rule is not likely to have significant effects on the environment
because, as discussed in Unit VI.B., methylene chloride does not
present an unreasonable risk to the environment, though this proposed
rule does present the potential for small reductions in air emissions
and soil contamination associated with improper disposal of products
containing methylene chloride. The effects of this proposed 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.
2. Costs and Benefits of the Proposed Regulatory Action and of the One
or More Primary Alternative Regulatory Actions Considered by the
Administrator
The costs and benefits that can be monetized for this proposed rule
are
[[Page 28329]]
described at length in in the Economic Analysis (Ref. 3). The non-
closure-related costs for this proposed rule are estimated to be $13.2
million annualized over 20 years at a 3% discount rate and $14.5
million annualized over 20 years at a 7% discount rate. The monetized
benefits are estimated to be $17.7 to $18.5 million annualized over 20
years at a 3% discount rate and $13.4 to $13.9 million annualized over
20 years at a 7% discount rate.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary alternative regulatory action is described in detail in Unit
IV.B. The estimated annualized, non-closure-related costs of the
primary alternative regulatory action are $12.4 million at a 3%
discount rate and $13.3 million at a 7% discount rate over 20 years
(Ref. 3). The estimated annualized benefits of this primary alternative
regulatory action are $17.7 to $18.5 million at a 3% discount rate and
$13.4 to $13.9 million at a 7% discount rate over 20 years (Ref. 3).
This proposal is expected to achieve health benefits for the
American public, some of which can be monetized and others that, while
tangible and significant, cannot be monetized. EPA believes that the
balance of costs and benefits of this proposal cannot be fairly
described without considering the additional, non-monetized benefits of
mitigating the non-cancer adverse effects. The multitude of adverse
effects from methylene chloride exposure can profoundly impact an
individual's quality of life, as discussed in Units II.A. (overview),
III.B.2. (description of the unreasonable risk), V.A. (discussion of
the health effects), and the Risk Evaluation. 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 proposed rule. As the proposed option is more restrictive and
therefore more protective than the primary alternative option, the
value of unquantified benefits may be higher for the proposed option.
This implies that the difference between the proposed and primary
alternative options is larger than it appears, in favor of the proposed
option, based on monetized benefits alone.
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. 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-
response, because epidemiological studies lacked controls for co-
exposures, animal studies observed effects mostly at higher methylene
chloride concentrations, and EPA identified no relevant mechanistic
information (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. 59).
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 Proposed 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
proposed regulatory action is to prevent user deaths resulting from
exposure to methylene chloride. The proposed regulatory action would
cost, excluding closure-related costs, $9.9 million per potential
prevented death while the primary alternative regulatory action would
cost, excluding closure-related costs, $9.3 million per potential
prevented death (using the 3% discount rate). While the primary
alternative regulatory action would be lower in cost compared to the
proposed action, the difference is small and both options are
considered to have similar levels of cost effectiveness in decreasing
the potential for death from exposure to methylene chloride (Ref. 3).
See Chapter 9 of the Economic Analysis for greater detail on the cost
effectiveness of the proposed and primary regulatory actions.
4. Requests for Comment on Economic Analysis
As described in the Economic Analysis, two conditions of use,
Processing: Recycling and Disposal, are responsible for the majority
(~60%) of the estimated total $13 million non-closure-related costs of
the rule. Given the prevalence of small entities in this sector, EPA
requests comment on what regulatory flexibilities, within the scope of
TSCA and mitigating unreasonable risk, may be afforded to these
conditions of use to reduce burden of complying with the WCPP.
As described in the Economic Analysis and the Alternatives
Assessment, alternatives for methylene chloride as a processing aid
were not identified. EPA requests information on potential alternative
processing aids to methylene chloride as it relates to the proposed
regulatory option for this COU. The Economic Analysis includes a
qualitative discussion of uncertainty in cost estimates, including
uncertainties related to the cost of reformulating products that
currently contain methylene chloride, which
[[Page 28330]]
could be underestimated, or overestimated. EPA requests comment on
additional aspects of reformulation, including any costs that may be
associated with mitigating countervailing risks of alternative
formulations. Additionally, EPA requests comment on the degree to which
qualities or properties of methylene chloride, beyond those discussed
in the Economic Analysis and summarized in Unit VI.C. may make
methylene chloride a preferable choice when compared to alternatives
with similar costs and effectiveness. EPA also requests comment
regarding information to estimate transition costs to suitable
alternatives, including how often these costs might be incurred or what
the specific costs would be per-user or per-firm when they are
incurred. Similarly, EPA requests comment on how costs and economic
impacts from firm closures may be reduced with longer compliance
timeframes. Finally, EPA requests comment on how better to monetize the
benefits of each alternative in the Economic Analysis and whether EPA
should consider any other categories of benefits.
VII. 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, for this proposed rule, 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.
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 proposed rule, EPA has
coordinated with appropriate Federal executive departments and agencies
including OSHA and the Consumer Product Safety Commission (CPSC) to
identify their respective authorities, jurisdictions, and existing laws
with regard to risk evaluation and risk management of methylene
chloride, which are summarized in this Unit.
As discussed in more detail in Unit II.C., 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. As noted previously,
to set PELs for chemical exposure, OSHA must first establish that the
new standards are economically and technologically feasible (79 FR
61384, 61387, Oct. 10, 2014). When setting the 8-hour TWA PEL for
methylene chloride in 1997, OSHA concluded that ``at the 25 ppm PEL the
residual risk still greatly exceeds any significant risk threshold,''
but set the PEL at that level because it was the lowest level for which
OSHA could document technological and economic feasibility across the
affected industries at that time (62 FR 1494, 1575 January 10, 1997; 63
FR 50172, 50713, September 22, 1998). Thus, if OSHA were to initiate a
new action to lower its PEL, the difference in requirements between the
OSH Act and TSCA could result in the OSHA PEL still being set at a
higher level than the risk-based exposure limit for methylene chloride
determined by EPA to be necessary to address the unreasonable risk
identified under TSCA. However, EPA believes that the feasibility of
technology has advanced over the last 25 years such that for certain
conditions of use, based on monitoring data received during the risk
evaluation and feedback during SBAR, EPA's risk-based level of 2 ppm is
achievable, and indeed, is already being achieved. For most industrial
and commercial conditions of use, EPA has determined it is not feasible
to meet the ECEL and is thus proposing to prohibit those uses. In
addition, OSHA may set exposure limits for workers, but its authority
is limited to the workplace and does not extend to consumer uses of
hazardous chemicals, and thus OSHA cannot address the unreasonable risk
from methylene chloride under all of its conditions of use, which
include consumer uses. OSHA also does not have direct authority over
State and local employees, and it has no authority over the working
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
CPSC, under authority provided to it by Congress in the CPSA,
protects the public from unreasonable risk of injury or death
associated with 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. CPSC issued its methylene chloride
guidance under the FHSA, which does not include the same jurisdictional
exceptions as the CPSA. Recently, CPSC revised its labeling guidance
for methylene chloride under the FHSA to provide more immediate
guidance and clarity to consumers and industry regarding the acute
hazards associated with using methylene chloride-based paint removers
while they remain on the market (83 FR 12254, March 21, 2018). However,
while EPA believes that the updated CPSC labeling guidance, if properly
implemented by industry, would prevent some users from using methylene
chloride paint and coating removal products in an unsafe manner, for
the reasons described in the proposal, it is unlikely to address the
unreasonable risks to consumers under a 9(a) determination by the
Administrator. Furthermore, in a letter to EPA regarding paint and
coating removers, CPSC stated ``because TSCA gives EPA the ability to
reach both occupational and consumer uses, we recognize that EPA may
address risks associated with these chemicals in a more cohesive and
coordinated manner given that CPSC lacks authority to address
occupational hazards.'' (EPA-HQ-OPPT-2016-0231-0154).
Therefore, EPA maintains that TSCA is the appropriate vehicle to
deliver broad protections to consumers who may use formulations that
contain methylene chloride and whose use drives the unreasonable risk
of injury to health from methylene chloride. An action under TSCA also
would be 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 2-year statutory timeframe for proposing and finalizing
requirements to address unreasonable risk. Regulating methylene
chloride's
[[Page 28331]]
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.
Moreover, 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., In a TSCA section 6
risk management rule, following an unreasonable risk determination, EPA
must apply risk management requirements to the extent necessary so that
the chemical no longer presents unreasonable risk and only consider
costs and benefits of the regulatory action to the extent practicable,
15 U.S.C. 2605(a) and (c)(2). By contrast, a consumer product safety
rule under the CPSA must include a finding that ``the benefits expected
from the rule bear a reasonable relationship to its costs.'' 15 U.S.C.
2058(f)(3)(E). Additionally, the 2016 amendments to TSCA reflect
Congressional intent to ``delete the paralyzing `least burdensome'
requirement,'' 162 Cong. Rec. S3517 (June 7, 2016), a reference to TSCA
section 6(a) as originally enacted in 1976, which required EPA to use
``the least burdensome requirements'' that protect ``adequately''
against unreasonable risk, 15 U.S.C. 2605(a) (1976). However, a
consumer product safety rule under the CPSA must impose ``the least
burdensome requirement which prevents or adequately reduces the risk of
injury for which the rule is being promulgated.'' 15 U.S.C.
2058(f)(3)(F) Analogous requirements, also at variance with recent
revisions to TSCA, affect the availability of action CPSC may take
under the FHSA relative to action EPA may take under TSCA. 15 U.S.C.
1262. But EPA's substantive burden under TSCA section 6(a) is to apply
requirements to the extent necessary so that the chemical substance no
longer presents the unreasonable risk that was determined in accordance
with TSCA section 6(b)(4)(A) without consideration of cost or other
non-risk factors.
EPA therefore concludes that TSCA is the most appropriate
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. This
unreasonable risk can be addressed in a more coordinated, efficient,
and effective manner under TSCA than under different laws implemented
by different agencies. Further, there are key differences between the
finding requirements of TSCA and those of the OSH Act, CPSA, and FHSA.
For these reasons, in the Administrator's discretion, the Administrator
has analyzed this issue and does not determine that unreasonable risk
from 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, 7), regulations under those EPA statutes
largely regulate releases to the environment, rather than occupational
or consumer exposures. While these limits on releases to the
environment are protective in the context of their respective statutory
authorities, regulation under TSCA is also appropriate for occupational
and consumer exposures and in some cases can provide upstream
protections that would prevent the need for release restrictions
required by other EPA statutes (e.g., RCRA, CAA, CWA).
The primary exposures and unreasonable risk to consumers,
bystanders, workers, and occupational non-users would be addressed by
EPA's proposed prohibitions and restrictions under TSCA section 6(a).
In contrast, the timeframe and any exposure reduction as a result of
updating regulations for methylene chloride under RCRA, CAA, or CWA
cannot be estimated, nor would they address the direct human exposure
to consumers, bystanders, workers, and occupational non-users from the
conditions of use evaluated in the 2020 Risk Evaluation for Methylene
Chloride. More specifically, none of EPA's other statutes (e.g., RCRA,
CAA, and CWA) can address exposures to workers and occupational non-
users related to the specific activities that result in occupational
exposures associated with disposal activities. EPA therefore concludes
that TSCA is the most appropriate regulatory authority able to prevent
or reduce risks of methylene chloride to a sufficient extent across the
range of conditions of use, exposures, and populations of concern.
For these reasons, the Administrator does not determine that
unreasonable risk from methylene chloride under its conditions of use,
as evaluated in the 2020 Risk Evaluation for Methylene Chloride, 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 confidential
business information that may occur if this rule is finalized as
proposed. 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
confidential business information regarding that chemical substance and
submitted pursuant to TSCA will be ``presumed to no longer apply,''
subject to the limitations identified in TSCA section 14(b)(4)(B)(i)
through (iii). If this rule is finalized as proposed, then pursuant to
TSCA section 14(b)(4)(B)(iii), the presumption against protection from
disclosure would apply only to information about the specific
conditions of use that this rule would prohibit or phase out.
Similarly, if this rule is finalized as proposed, the presumption
against protection from disclosure would not apply to certain uses that
this rule proposes to exempt from the ban or phase-out pursuant to TSCA
section 6(g). Per TSCA section 14(b)(4)(B)(i), the presumption against
protection would not apply to information about these conditions of
use. However, the presumption against protection would apply to
information about conditions of use that are not exempt from the ban or
phase-out, pursuant to TSCA section 6(g). Manufacturers or processors
seeking to protect such information would be able to submit a request
for nondisclosure as provided by TSCA sections 14(b)(4)(C) and
14(g)(1)(E). Any request for nondisclosure would need to be
[[Page 28332]]
submitted within 30 days after receipt of notice from EPA under TSCA
section 14(g)(2)(A). EPA anticipates providing such notice via the
Central Data Exchange (CDX).
D. TSCA Section 26 Considerations
In accordance with TSCA section 26(h), EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science.
As in the case of the unreasonable risk determination, risk management
decisions for this proposed rule, as discussed in Unit III.B.3. and
Unit V., were based on a risk evaluation that was subject to public
comment and independent, expert peer review, and developed in a manner
consistent with the best available science and based on the weight of
the scientific evidence as required by TSCA sections 26(h) and (i) and
40 CFR 702.43 and 702.45. In particular, the ECEL and EPA STEL values
incorporated into the WCPP are derived from the analysis in the 2020
Risk Evaluation for Methylene Chloride; they likewise represent
decisions based on the best available science and the weight of the
scientific evidence (Ref. 11). The ECEL value of 2 ppm as an 8-hour TWA
is based on the chronic non-cancer human equivalent concentration (HEC)
for liver toxicity identified in the 2020 Risk Evaluation for Methylene
Chloride, which is the concentration at which an adult human would be
unlikely to suffer adverse effects if exposed for a working lifetime,
including susceptible subpopulations. The EPA STEL of 16 ppm as a 15-
minute TWA is derived from the non-cancer endpoint of central nervous
system depression resulting from acute exposures that was identified in
the 2020 Risk Evaluation for Methylene Chloride.
The extent to which the various information, procedures, measures,
methods, protocols, methodologies, or models, as applicable, used in
EPA's decisions have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rule. Additional information on the peer review and public
comment process, such as the peer review plan, the peer review report,
and the Agency's response to public comments, can be found at EPA's
risk evaluation docket at EPA-HQ-OPPT-2020-0465.
VIII. Requests for Comment
EPA is requesting public comment on all aspects of this proposal,
including the proposed and primary alternative regulatory actions and
all supporting analysis. Additionally, within this proposal, the Agency
is soliciting feedback from the public on specific issues throughout
this proposed rule. For ease of review, this section summarizes those
specific requests for comment.
1. EPA is requesting public comment on the proposed regulatory
action and primary alternative regulatory action. (Unit III.A.).
2. EPA is requesting comment on the proposed rule's TSCA section
6(g) exemptions' provisions and rationales. (Unit III.A.).
3. Following Panel recommendations in the Panel report (Ref. 6) and
in response to SERs recommendations, EPA is requesting comment on the
following topics as outlined in the SBAR Panel Report:
a. EPA requests comment on the extent to which a regulation under
TSCA section 6(a) could minimize requirements, such as testing and
monitoring protocols, recordkeeping, and reporting requirements, which
may exceed those already required under OSHA's regulations for
methylene chloride.
b. EPA requests comment on the feasibility of complying with and
monitoring for an Existing Chemical Exposure Limit (ECEL) of 2 ppm. In
particular, EPA requests comment on changes that may be needed to meet
such a standard, for example changes related to elimination of
methylene chloride or substitution, engineering controls, process
changes, and monitoring frequency.
c. EPA requests comment on workplace monitoring for implementation
of an ECEL. EPA is soliciting information related to the frequency of
monitoring, initial monitoring, and periodic monitoring for workplace
exposure levels and how a lower exposure level from the OSHA PEL may
impact the frequency of periodic monitoring. Specifically, EPA requests
comment about when this may impact the frequency of periodic monitoring
where initial monitoring shows that employee exposures are above the
level that would initiate requirements for compliance with the ECEL or
an OSHA STEL.
d. EPA requests comment on reasonable compliance timeframes for
small businesses, including timeframes for reformulation of products or
processes containing methylene chloride; implementation of new
engineering or administrative controls; changes to labels, SDSs, and
packaging; implementation of new PPE, including training and monitoring
practices; and supply chain management challenges. EPA also requests
comment on establishing differing compliance or reporting requirements
or timetables that take into account the limited resources available to
small entities.
e. EPA requests comment on the feasibility and availability of
various prescriptive engineering controls to reduce exposure levels,
and information on any technologies or prescriptive control options
used in combination for addressing the unreasonable risk.
f. EPA requests comment on providing an option of either complying
with the ECEL or implementing various administrative and engineering
controls, such as those employed in a closed-loop system, including
information on how a small business can demonstrate that such controls
eliminate the unreasonable risk for that use.
g. EPA requests comment on establishing a certification program for
the use of methylene chloride by the furniture refinishing industry as
well as measures to address the unreasonable risk for commercial use of
methylene chloride in paint and coating removal for furniture
refinishing.
h. EPA requests comment on means by which small businesses can
maintain access to methylene chloride for industrial and commercial
uses including establishing training, certification, and limited access
programs.
i. EPA requests comment on TSCA section 6(g)(1) exemptions for any
MIL-SPEC programs where methylene chloride is specified or required for
a specific end-use application.
j. EPA requests comment on temporary work practices to allow for
limited circumstances, including but not limited to equipment failure
or maintenance activity, where monitoring may not be feasible to comply
with an ECEL.
k. EPA requests comment on the extent to which methylene chloride
may be used in the same facility for TSCA and non-TSCA uses.
4. EPA requests comment on whether a definition should be
promulgated for each condition of use of methylene chloride and, if so,
whether the descriptions in Unit III.B.1.f. are consistent with the
conditions of use evaluated in the 2020 Risk Evaluation for Methylene
Chloride and whether they provide a sufficient level of detail such
that they would improve the clarity and readability of the regulation
if promulgated. (Unit III.B.1.f.).
5. EPA is requesting comment on the proposed implementation
timeframe for the WCPP requirements; EPA proposes that they would take
effect 180 days
[[Page 28333]]
after publication of the final rule, at which point entities would be
required to conduct initial monitoring (as described in Unit IV.A.1.c.)
and develop an exposure control plan within 1 year of publication of
the final rule (Unit IV.A.1.a. and d.). (Unit IV.A.1.a.).
6. EPA acknowledges that new monitoring methods or technologies may
have been developed since 1997 that would allow for greater accuracy,
and thus a smaller range for monitoring results, and EPA requests
comment on the exposure monitoring accuracy requirements. (Unit
IV.A.1.c.i.).
7. EPA acknowledges that the 25% buffer for the 8-hour and 15-
minute TWA potentially could allow some exposures above the exposure
limits proposed here. EPA requests comment on these buffers' effects
and any alternatives to account for measurement variance or
uncertainty. (Unit IV.A.1.c.i.).
8. EPA is soliciting comments regarding how owners and operators
could conduct initial exposure monitoring to ensure that it is
representative of all tasks likely to be conducted by potentially
exposed persons. (Unit IV.A.1.c.ii.).
9. EPA is soliciting comments regarding the proposed requirement
for recurring 5-year initial exposure monitoring. (Unit IV.A.1.c.ii.).
10. EPA requests comment on the timeframes for periodic monitoring
outlined in Unit IV.A.1.c.iii, particularly whether more frequent
monitoring may be possible or recommended. (Unit IV.A.1.c.iii.).
11. EPA is requesting public comments on the proposed conditions
for periodic monitoring for methylene chloride as part of
implementation of the WCPP that differ from OSHA's existing monitoring
requirements under 29 CFR 1910.1052. (Unit IV.A.1.c.iv.).
12. EPA requests comment on the degree to which additional guidance
related to use of gloves might be necessary. Additionally, EPA requests
comment on whether EPA should specifically incorporate dermal
protection into the exposure control plan and require consideration of
the hierarchy of controls for dermal exposures. (Unit IV.A.1.e.i.).
13. EPA requests comment on the 15-day timeframe for notification
of potentially exposed persons of monitoring results and the
possibility for a shorter timeframe, such as 5 days. (Unit
IV.A.1.f.ii.).
14. EPA requests comment relative to the ability of owners or
operators to conduct initial monitoring by 180 days after publication
of the final rule, and anticipated timelines for any procedural
adjustments needed to comply with the requirements outlined in Unit
IV.A.1. (Unit IV.A.1.g.).
15. EPA requests comment on the impacts, if any, the proposed
prohibition described in Unit IV.A.2., or other aspects of this
proposal, may have on the production and availability of any food, food
additive, drug, cosmetic, device, or other substance excluded from the
definition of ``chemical substance'' under TSCA section 3(2)(B)(ii)
through (vi). (Unit IV.A.2.).
16. EPA requests comment regarding the number of entities that
could potentially close as well as associated costs with a prohibition
of methylene chloride for certain industrial and commercial conditions
of use identified in Unit IV.A.2. (Unit IV.A.2.).
17. EPA would like comment on whether it should consider a de
minimis level of methylene chloride in formulations for certain
continuing industrial and commercial uses to account for impurities
(e.g., 0.1% or 0.5%) when finalizing the prohibitions described in Unit
IV.A., and, if so, what level should be considered de minimis (Units
IV.A.2., and IV.A.3.).
18. EPA is proposing that the prohibition of certain industrial and
commercial conditions of use described in Unit IV.A.2 would occur 90
days after the publication date of the final rule for manufacturers,
180 days for processors, 270 days for distributing to retailers, 360
days for all other distributors and retailers, and 450 days for
industrial and commercial uses. EPA requests comment on whether
additional time is needed, for example, for products affected by
proposed restrictions to clear the channels of trade. (Unit IV.A.2.).
19. EPA requests comments on an appropriate, predictable process
that could expedite reconsideration for uses that Federal agencies or
their contractors become aware of after the final rule is issued using
the tools available under TSCA, aligning with the requirements of TSCA
section 6(g). EPA requests comment on the appropriate types of
information for use in evaluating this type of category of use, and
other considerations that should apply. (Unit IV.A.2).
20. EPA would like comment on whether distributors that are not
retailers should be required to use tax IDs or other verification
methods prior to selling methylene chloride or products containing
methylene chloride to ensure consumers are not purchasing methylene
chloride or commercial or industrial products containing methylene
chloride. (Unit IV.A.3.).
21. During litigation (see Lab. Council for Latin Am. Advancement
v. United States Env't Prot. Agency, 12 F.4th 234 (2d Cir. 2021)) on a
previous rulemaking (84 FR 11420, March 27, 2019) petitioners argued
that EPA's definition of ``retailer'' was so broad as to cover all
commercial entities, creating supply chain issues for commercial users
seeking to attain and use the chemical for commercial activities. EPA
has not found this to be the case; small businesses that are non-retail
distributors exist and even participated as small entity
representatives consulted as part of the SBAR process for this
rulemaking. Nonetheless, EPA is soliciting comment on whether similar
supply chain issues for uses that are permitted under the WCPP are
anticipated. (Unit IV.A.3.).
22. EPA is proposing that the prohibition of manufacturing,
processing, and distribution for consumer use described in Unit IV.A.3.
would occur 90 days after the publication date of the final rule 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. EPA requests comment on whether
additional time is needed, for example, for products affected by
proposed restrictions to clear the channels of trade. (Unit IV.A.3.).
23. EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in Unit IV.A.4. (Unit IV.A.4.b.).
24. EPA recognizes that in some situations, certain facilities may
do both Federal contractor and commercial aviation work and may use
methylene chloride for paint and coating removal from safety-critical,
corrosion-sensitive components on military, Federal, or commercial
aviation. EPA requests comment on whether such co-located activities in
a facility should be subject to the WCPP, rather than the exemption
under TSCA section 6(g). Additionally, EPA seeks additional information
and requests comment on whether it is possible to distinguish between
commercial aviation facilities that would be able to meet the WCPP and
those that would not, including what criteria should be used for such
distinctions (e.g., size of facility, volume or type of work performed,
record of exposure reduction practices). EPA also requests comment on
the extent to which specific commercial aviation and aerospace uses or
types of facilities could fully comply with the WCPP to address
identified unreasonable risk. (Unit IV.A.5.a.i.).
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25. EPA requests comments on all aspects of the proposed TSCA
section 6(g) exemption from the proposed prohibition on use of
methylene chloride in commercial paint and coating removal for paint
and coating removal essential for critical infrastructure by
certificated commercial air carriers, commercial operators, or repair
stations, or by manufacturers of aircraft or aerospace vehicles and
hardware, noting that the proposed exemptions would be limited to the
safety-critical, corrosion-sensitive components on aircraft and
aerospace vehicles, including safety-critical components. (Unit
IV.A.5.a.ii.).
26. EPA requests comment on this TSCA section 6(g) exemption for
continued emergency use of methylene chloride in the furtherance of
NASA's mission as described in this unit, and whether any additional
conditions of use should be included, in particular for any uses
qualified for space flight for which no technically or economically
feasible safer alternative is available. Additionally, EPA requests
comment on what would constitute sufficient justification of an
emergency. (Unit IV.A.5.b.ii.).
27. EPA requests comments on all aspects of the preliminary
determination that a TSCA section 6(g) exemption is not warranted for
the use of methylene chloride in furniture refinishing, including
information on the availability of alternatives and the time needed to
implement alternatives. EPA emphasizes that the Agency is seeking input
regarding whether an exemption is needed and welcomes information
related to this condition of use during the public comment period.
(Unit IV.A.5.c.).
28. Primary alternative regulatory action: EPA requests comment on
the ways in which methylene chloride may be used in the additional
conditions of use that would be subject to a WCPP under the primary
alternative regulatory action, and the degree to which users of
methylene chloride in these sectors could successfully implement the
WCPP, including requirements to meet an ECEL and EPA STEL, as described
in Unit IV.A.1., for the conditions of use listed for the primary
alternative regulatory action in Unit IV.B. EPA is also requesting
comment on whether to consider a regulatory alternative that would
subject more conditions of use to a WCPP, instead of prohibition, than
those currently contemplated in the primary alternative regulatory
action. EPA also requests monitoring data and detailed descriptions of
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. (Unit IV.B.).
29. Primary alternative regulatory action: EPA requests comment on
the degree to which entities using methylene chloride as a processing
aid may comply with the proposed WCPP requirements for methylene
chloride. EPA requests comment on the degree to which alternatives may
or may not be available for use of methylene chloride as a heat
transfer fluid and in other processing aid applications. (Unit IV.B.).
30. Primary alternative regulatory action: EPA requests comment on
the ability of regulated entities engaged in the additional conditions
of use that would be subject to a WCPP under the primary alternative
regulatory action to conduct initial monitoring within 12 months,
anticipated timelines for any procedural adjustments needed to comply
with the requirements, and the extent to which this option could result
in additional exposure, compared the proposed regulatory option as
described in Unit IV.A. Overall, EPA requests comment on any advantages
or drawbacks for the timelines outlined in Unit IV.B., compared to the
timelines identified for the proposed regulatory action in Unit IV.A.
(Unit IV.B.)
31. EPA requests comment and further information regarding the
Agency's expectations that Federal and Federal contractor facilities
would be subject to a higher level of oversight than non-Federal or
contractor facilities, and that existing or expected controls would be
successful in achieving the requirements of the WCPP. (Unit V.A.1.).
32. EPA requests comment and further information regarding the
Agency's expectations that the facilities in which use of methylene
chloride as a bonding agent in specialty batteries is carried out are
industrialized and highly controlled, and that existing or expected
exposure reduction and workplace controls would be successful in
achieving the requirements of the WCPP. EPA also notes that while the
Agency is not aware of any similar use of methylene chloride as a
bonding element for batteries for commercial spaceflight or other use,
it requests comment and information on any such use. (Unit V.A.1.).
33. EPA is requesting comment on what regulatory flexibilities may
be afforded to entities that will continue to recycle and dispose of
methylene chloride under the proposed regulation. (Unit V.A.1.).
34. EPA is requesting comment on the inclusion of a certification,
training, and limited access program for any uses that would be subject
to a WCPP, in addition to the requirements outlined in Unit IV.A.1.
(Unit V.A.4.).
35. For some conditions of use, EPA was unable to identify products
currently available for sale that contain methylene chloride. EPA is
soliciting comments on whether there are actually products in use or
available for sale relevant to these conditions of use that contain
methylene chloride at this time, so that EPA can ascertain whether
there are alternatives that benefit human health or the environment.
(Unit V.B.).
36. EPA is requesting comment on the alternatives analysis as a
whole. (Unit V.B.).
37. EPA considered the employment impacts of this proposed rule,
and found that the direction of change in employment is uncertain, but
EPA expects the short-term and longer-term employment effects to be
small. To that end, EPA is requesting public comment on short term and
longer-term employment effects from this proposal. (Unit VI.D.1.).
38. As described in the Economic Analysis, two conditions of use,
Processing: Recycling and Disposal, are responsible for the majority
(~60%) of the estimated total $12 million in non-closure-related costs
of the rule. Given the prevalence of small entities in this sector, EPA
requests comment on what regulatory flexibilities, within the scope of
TSCA and mitigating unreasonable risk, may be afforded to these
conditions of use to reduce burden of complying with the WCPP. (Unit
VI.D.4.).
39. As described in the Economic Analysis and the Alternatives
Analysis, alternatives for methylene chloride as a processing aid were
not identified. EPA requests information on potential alternative
processing aids to methylene chloride as it relates to the proposed
regulatory option for this COU. (Unit VI.D.4.).
40. The Economic Analysis includes a qualitative discussion of
uncertainty in cost estimates, including uncertainties related to the
cost of reformulating products that currently contain methylene
chloride, which could be underestimated, or overestimated. EPA requests
comment on additional aspects of reformulation, including any costs
that may be associated with mitigating countervailing risks of
alternative formulations. (Unit VI.D.4.)
41. EPA requests comment on the degree to which qualities or
properties of methylene chloride, beyond those discussed in the
Economic Analysis and summarized in Unit VI.C., may make methylene
chloride a preferable choice when compared to alternatives with
[[Page 28335]]
similar costs and effectiveness. (Unit VI.D.4.)
42. EPA requests comment regarding information to estimate
transition costs to suitable alternatives, including how often these
costs might be incurred or what the specific costs would be per-user or
per-firm when they are incurred. (Unit VI.D.4.)
43. EPA requests comment on how costs and economic impacts from
firm closures may be reduced with longer compliance timeframe. (Unit
VI.D.4.)
44. EPA requests comment on how better to monetize the benefits of
each alternative in the Economic Analysis and whether EPA should
consider any other categories of benefits. (Unit VI.D.4.)
IX. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation for Methylene Chloride (MC). EPA Document
#740-R1-8010
2. EPA. Final Revised Unreasonable Risk Determination for Methylene
Chloride. November 2022.
3. EPA. Economic Analysis of the Proposed Regulation of Methylene
Chloride. RIN 2070-AK70. August 2022.
4. Public Workshop on Use of Methylene Chloride in Furniture
Refinishing in collaboration with the Small Business Administration
Office of Advocacy. September 12, 2017.
5. EPA Workshop on Furniture Refinishing and Methylene Chloride.
September 12, 2017.
6. 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. October 28, 2021.
7. EPA. Regulatory Actions Pertaining to Methylene Chloride. January
24, 2023.
8. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16,
2022.
9. NIOSH. Hierarchy of Controls. Accessed October 6, 2022
10. EPA. Methylene Chloride; Revision to Toxic Substances Control
Act (TSCA) Risk Determination; Notice of Availability. Federal
Register (87 FR 67901, November 10, 2022
11. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Methylene Chloride. December 10, 2020.
12. OSHA. Standard Interpretations: 8-hr total weight average (TWA)
permissible exposure limit (PEL). Accessed October 6, 2022.
13. Putz et al. A comparative study of the effects of carbon
monoxide and methylene chloride on human performance. J Environ
Pathol Toxicol 2: 97-112. 1979.
14. NTP. NTP Toxicology and Carcinogenesis Studies of
Dichloromethane (Methylene Chloride) (CAS No. 75-09-2) in F344/N
Rats and B6C3F1 Mice (Inhalation Studies). National Toxicology
Program technical report series vol. 306. 1986.
15. K.D. Nitschke; et al. Methylene Chloride: A 2-Year Inhalation
Toxicity and Oncogenicity Study in Rats. Fundam Appl Toxicol 11: 48-
59. 1988.
16. K.D. Nitschke; et al. Methylene Chloride: Two-Generation
Inhalation Reproductive Study in Rats. Fundam Appl Toxicol 11: 60-
67. 1988.
17. 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).
18. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
19. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
20. EPA Press Release. EPA Announces Path Forward for TSCA Chemical
Risk Evaluations. June 2021.
21. SACC. Science Advisory Committee on Chemicals Meeting Minutes
and Final Report No. 2022-01. March 15-17, 2022.
22. 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 22,
2023.
23. 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 Toxics. November
12-17, 2020.
24. Liz Hitchcock; Safer Chemicals Healthy Families. 11/20
Environmental Justice Consultations for 1-Bromopropane and Methylene
Chloride. November 20, 2020.
25. California Communities Against Toxics et al. Comment letter re
TSCA environmental justice consultations. November 13, 2020.
26. Swati Rayasam; Program on Reproductive Health and the
Environment (PRHE). PRHE follow up documents from EJ consultation
meeting. November 30, 2020.
27. EPA. Initial Regulatory Flexibility Analysis for Methylene
Chloride; Regulation of Methylene Chloride under TSCA Sec. 6(a)
Proposed Rule; RIN 2070-AK70. November 22, 2022.
28. EPA. Methylene Chloride: Risk Evaluation and Risk Management
under TSCA Section 6. SBA Small Business Roundtable. September 11,
2020.
29. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Methylene Chloride under TSCA Section 6(a). October 27, 2022.
30. EPA. 2021 Policy on Children's Health. October 5, 2021.
31. Steve Shestag; The Boeing Company. Re: Comments Supporting
Request for Additional Information on Methylene Chloride; Rulemaking
Under TSCA Section 6(a). June 24, 2022.
32. Anh Hoang; Kathleen Fagan; Dawn L. Cannon; et al. Assessment of
Methylene Chloride-Related Fatalities in the United States, 1980-
2018. JAMA Intern Med. 2021.
33. DHHS Centers for Disease Control and Prevention. NIOSH Chemical
Carcinogen Policy. Publication No. 2017-100. July 2017.
34. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register (62 FR 1494, of January 10, 1997).
35. OSHA; NIOSH. Hazard Alert: Methylene Chloride Hazards for
Bathtub Refinishers. January 2013.
36. OSHA. 1910.1052 App A--Substance Safety Data Sheet and Technical
Guidelines for Methylene Chloride. Accessed October 6, 2022.
37. EPA. Final Rule. Methylene Chloride; Regulation of Paint and
Coating Removal for Consumer Use Under TSCA Section 6(a). Federal
Register (84 FR 11420, March 27, 2019
38. Leslie Riegle. Re: Regulation of Certain Uses Under Toxic
Substances Control Act: Methylene Chloride and N-methylpyrrolidone.
Aerospace Industries Association (AIA). May 19, 2017.
39. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016.
40. EPA. An Alternatives Assessment for Use of Methylene Chloride.
August 2022.
41. White House. United States Space Priorities Framework. December
2021.
42. Federal Aviation Administration (FAA). Flight Program
Operations. Last updated: April 13, 2022.
43. Aaron Rice; EaglePicher Technologies. Re: TSCA Section 6(g)
Exemption Request for Use of N-methylpyrrolidone and Methylene
Chloride in Production of Specialized Batteries. June 3, 2022.
44. EPA. Meeting with Arkema and EPA to discuss comments submitted
by Arkema on Trichloroethylene (TCE) and Methylene Chloride.
December 7, 2017.
45. Halogenated Solvents Industry Alliance Inc. (HSIA). Docket No.
EPA-HQ-OPPT-2016-0742. August 16, 2018.
46. 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. Appendix B: Written Comments
Submitted by Small Entity Representatives. October 28, 2021.
47. EPA. Proposed Rule. Methylene Chloride and N-Methylpyrrolidone;
Regulation of Certain Uses Under TSCA Section 6(a). Federal Register
(82 FR 7464, January 19, 2017
48. Kenneth M. Walter and Val C. Sackmann. Material Substitution of
Methylene Chloride (MeCl)/Phenol Paint Stripper. AIHce 2016. May 21-
26, 2016.
[[Page 28336]]
49. EPA. Meeting with Baron-Blakeslee on Risk Management under TSCA
Section 6 for Trichloroethylene, Perchloroethylene, 1-Bromopropane,
and Methylene Chloride. April 1, 2021
50. EPA. ANPRM. Methylene Chloride; Commercial Paint and Coating
Removal Training, Certification and Limited Access Program. Federal
Register (84 FR 11466, March 27, 2019
51. 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. November 16-19, 2020.
52. EPA. Risk Calculator for Consumer Inhalation and Dermal
Exposures. June 2020.
53. John Kelley and Thomas Considine. Performance Evaluation of Hap-
Free Paint Strippers vs. Methylene-Chloride-Based Strippers for
Removing Army Chemical Agent Resistant Coatings (CARC). Army
Research Laboratory. June 2006.
54. Benzyl Alcohol Paint Stripping. Joint Service Pollution
Prevention Opportunity Handbook. May 1, 2016.
55. EPA. Methylene Chloride: Fenceline Technical Support--Water
Pathway. October 19, 2022.
56. OEJECR EPA Complaint Nos. 01R-22-R6-, 02R-22-R6, and 04R-22-R6.
October 12, 2022.
57. EPA. Methylene Chloride: TRI Release Data Sensitivity Analysis.
September 1, 2022.
58. OMB. Guidance for Implementing Title II of [UMRA]. March 31,
1995.
59. Tara M. Cousineau and Alice D. Domar. Psychological Impact of
Infertility. Best Practice & Research Clinical Obstetrics and
Gynaecology, Vol. 21, Issue 2. 2007.
60. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA): Regulation of
Methylene Chloride under TSCA Section 6(a
61. EPA. TSCA Work Plan Chemical Risk Assessment; Methylene
Chloride: Paint Stripping Use. EPA Document #740-R1-4003. August
2014. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-risk-assessment-methylene.
62. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical
Methods with Related International Voluntary Consensus Standards. J
Occup Environ Hyg. 12(7):D107-15. 2015.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory Planning and Review and 13563:
Improving Regulation and Regulatory Review
This action is an economically significant regulatory action that
was submitted to the Office of Management and Budget (OMB) for review
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations during that review have been documented in the docket.
EPA prepared an Economic Analysis of the potential costs and benefits
associated with this action, which is available in the docket and is
summarized in Units I.E. and VI.D. (Ref. 3).
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted to OMB for review and comment under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 2735.01 (Ref. 60). You can find
a copy of the ICR in the docket for this rule, and it is briefly
summarized here.
There are two primary provisions of the proposed rule that may
increase burden under the PRA.
The first is downstream notification, which would be carried out by
updates to the relevant SDS and which would be required for
manufacturers, processors, and distributors in commerce of methylene
chloride, who would provide notice to companies downstream upon
shipment of methylene chloride about the prohibitions. The information
submitted to downstream companies through the SDS would provide
knowledge and awareness of the restrictions to these companies.
The second primary provision of the proposed rule that may increase
burden under the PRA is WCPP-related information generation,
recordkeeping, and notification requirements (including development of
exposure control plans; exposure level monitoring and related
recordkeeping; development of documentation for a PPE program and
related recordkeeping; development of documentation for a respiratory
protection program and related recordkeeping; development and
notification to potentially exposed persons (employees and others in
the workplace) about how they can access the exposure control plans,
exposure monitoring records, PPE program implementation documentation,
and respirator program documentation; and development of documentation
demonstrating eligibility for an exemption from the proposed
prohibitions, and related recordkeeping).
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce, or dispose of 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).
Frequency of response: On occasion.
Estimated number of respondents: 237,929.
Total estimated burden: 129,772 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $10,385,871 (per year), includes $2,809,809
annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. After display in the Federal
Register when approved, the OMB control numbers for EPA regulations in
40 CFR are listed in 40 CFR part 9 and displayed on the form and
instructions or collection portal, as applicable.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this proposed rule. You may also send your ICR-
related comments to OMB's Office of Information and Regulatory Affairs
using the interface at https://www.reginfo.gov/public/do/PRAMain. Find
this particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function. OMB
must receive comments no later than July 3, 2023. EPA will respond to
any ICR-related comments in the final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an initial regulatory flexibility analysis (IRFA) that
examines the impact of the proposed rule on small entities along with
regulatory alternatives that could minimize that impact (Ref. 27). The
complete IRFA is available for review in the docket and is summarized
here.
1. Need for the Rule
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to
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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 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 proposing to take action to the extent
necessary so that methylene chloride no longer presents such risk.
2. Objectives and Legal Basis for the Rule
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. EPA has determined through a TSCA section
6(b) risk evaluation that methylene chloride presents an unreasonable
risk under the conditions of use.
3. Description and Number of Small Entities to Which the Rule Will
Apply
The proposed rule potentially affects small manufacturers
(including importers), processors, distributors, retailers, users of
methylene chloride or of products containing methylene chloride, and
entities engaging in disposal. EPA estimates that the proposed rule
would affect approximately 237,930 firms using methylene chloride, of
which 230,266 are estimated to be small entities. End users with
economic and technologically feasible alternatives available do not
have estimated cost impacts beyond rule familiarization costs.
Alternative products that are drop-in substitutes (i.e., requiring no
changes by the user in how the product is used) are available for most
uses including adhesives, various degreasers, or lubricants and
greases. However, in some cases some effort might be required by firms
using methylene chloride products to identify suitable alternatives,
test them for their desired applications, learn how to use them safely
and effectively, and implement new processes for using the alternative
products. The information to estimate how often these costs might be
incurred or what the specific costs would be per-user or per-firm when
they are incurred is not available. Therefore, EPA is unable to
consider these costs quantitatively in the IRFA or Economic Analysis.
4. Projected Compliance Requirements
To address the unreasonable risk EPA has identified, EPA is
proposing to: (i) Prohibit the manufacture (including import),
processing, and distribution in commerce of methylene chloride for all
consumer use (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); (ii) prohibit most
industrial and commercial uses of methylene chloride; (iii) require a
WCPP for certain industrial and commercial conditions of use, including
inhalation exposure concentration limits; (iv) require recordkeeping
and downstream notification requirements for several conditions of use;
and (v) provide time-limited exemptions under TSCA section 6(g) for
military and civilian aviation from the prohibition addressing the use
of methylene chloride for paint and coating removal to avoid
significant disruptions to national security and critical
infrastructure.
EPA is proposing to prohibit most conditions of use. For other
conditions of use that drive the unreasonable risk determination for
methylene chloride, EPA proposes a WCPP to address the unreasonable
risk. A WCPP would encompass 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. Under a WCPP, owners or operators would have some
flexibility, within the parameters outlined in Unit IV.A.1., regarding
the manner in which they prevent exceedances of the identified exposure
thresholds. Therefore, EPA generally refers to the WCPP approach as a
non-prescriptive approach. In the case of methylene chloride, meeting
the exposure thresholds proposed 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.
EPA's proposed requirements include the specific exposure limits
that would be required to meet the TSCA section 6(a) standard to apply
one or more requirements to the substance so that it no longer presents
unreasonable risk, and also include ancillary requirements necessary
for the ECEL's successful implementation as part of a WCPP.
EPA is not proposing reporting requirements beyond downstream
notification (third-party notifications). Regarding recordkeeping
requirements, three primary provisions of the proposed rule relate to
recordkeeping. The first is recordkeeping for PPE: under the proposed
regulatory action, facilities complying with the rule through WCPP
would be required to develop and maintain records associated with a
dermal and inhalation protection and in accordance with an exposure
control plan. Additionally, under the proposed regulatory action,
facilities complying with the rule through a WCPP would be required to
monitor exposure levels and maintain records of this monitoring. Last,
under the proposed regulatory action, facilities complying with the
rule through a WCPP would be required to notify potentially exposed
persons of monitoring results.
a. 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.
b. Professional Skills Needed To Comply
Entities that would be subject to this proposal that manufacture
(including import), process, or distribute methylene chloride in
commerce for consumer use would be required to cease under the proposed
rule. The entity would be required to modify their Safety Data Sheet or
develop another way 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 under the proposed rule. Restriction or prohibition of these uses
will likely require the implementation of an alternative chemical or
the cessation of use of methylene chloride in a process or equipment
that may require persons
[[Page 28338]]
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 would be permitted to continue to manufacture,
process, distribute, use, or dispose of methylene chloride would be
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 or
health and safety professional. 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 information to be measured and recorded
may require persons with specialized skills such as an industrial
hygienist.
5. Relevant Federal Rules
Because of its health effects, methylene chloride is subject to
numerous State, Federal, and international regulations restricting and
regulating its use. The following is a summary of the regulatory
actions pertaining to methylene chloride; for a full description see
appendix A of the 2020 Risk Evaluation for Methylene Chloride.
EPA has issued numerous rules and notices pertaining to methylene
chloride under its various authorities. Methylene chloride is a
hazardous air pollutant (HAP) under the CAA (42 U.S.C. 7412(b)(1)). EPA
promulgated National Emission Standards for Hazardous Air Pollutants
(NESHAPs) for methylene chloride for several industrial source
categories.
With this proposed rule under TSCA section 6, certain uses
identified under these NESHAPs would be prohibited while other uses
would be subject to a WCPP. Moreover, the proposed rule would allow
methylene chloride's continued use in processing as a reactant for the
manufacture of HFC-32 and subject to compliance as part of a WCPP.
Programs within EPA implementing other environmental statutes,
including, but not limited to, the RCRA, the Comprehensive
Environmental Response, the Compensation, and Liability Act (CERCLA),
the SDWA, and the CWA, classify methylene chloride as a hazardous
waste, a hazardous substance, a volatile organic contaminant, and a
toxic pollutant, respectively. Releases into the environment of
methylene chloride in excess of 1,000 pounds must be reported under
CERCLA (40 CFR 302.4). While TSCA shares equity in the regulation of
methylene chloride, EPA does not anticipate this rule to duplicate nor
conflict with the aforementioned programs' classifications and
associated rules.
In addition to regulations administered by the EPA, methylene
chloride is also subject to regulations by other Federal agencies.
In 2005, the Secretary of Transportation listed methylene chloride
as a hazardous material with regard to transportation that is subject
to regulations prescribing requirements applicable to the shipment and
transportation of listed hazardous materials under the Hazardous
Materials Transportation Act (70 FR 34381, June 14, 2005).
OSHA has a standard for regulating methylene chloride under 29 CFR
1910.1052. The OSHA PEL, action level, STEL, and ancillary requirements
have established a strong precedent for exposure threshold requirements
within the regulated community. However, EPA recognizes that the
existing PEL and STEL do not eliminate the unreasonable risk identified
by EPA under TSCA, and EPA is therefore proposing to apply new, lower
exposure thresholds, derived from the 2020 Risk Evaluation for
Methylene Chloride, while aligning with existing requirements wherever
possible. For methylene chloride, this approach would eliminate the
unreasonable risk driven by certain conditions of use, reduce burden
for complying with the regulations, and provide the familiarity of a
pre-existing framework for the regulated community.
Under the FHSA enforced by CPSC, household products are required to
have hazardous substance labels for products that contain methylene
chloride. In 1987, CPSC issued a decision to require labeling of
household products that contain methylene chloride under the FHSA (52
FR 34698, September 14, 1987). Labels indicated that inhalation of
methylene chloride vapor has caused cancer in certain laboratory
animals, and the labels specified precautions to be taken during use by
consumers. In 2018, in response to a petition, CPSC updated the
labeling policy for paint strippers containing methylene chloride to
include a warning of the acute hazards from inhalation of methylene
chloride vapors in addition to the chronic hazards (83 FR 12254, March
21, 2018, and 83 FR 18219, April 26, 2018). With the proposed
prohibition on the manufacture, processing, and distribution in
commerce of methylene chloride for paint and coating removal under
TSCA, EPA anticipates that CPSC may require labeling for any products
that fall outside of the scope of TSCA and would not present conflict.
In pesticides, methylene chloride was registered as an
antimicrobial pesticide in 1974 pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.).
Methylene chloride was also a pesticide product inert ingredient used
as a solvent and co-solvent, and as a dispersing and wetting agent. In
June 1998, EPA published a Federal Register document that designated
methylene chloride as a List 1 inert ingredient due to its
toxicological and other concerning effects (63 FR 34384, June 24, 1998)
(FRL-5792-3). In 2002, EPA revoked pesticide tolerance exemptions for
methylene chloride as an extraction solvent and as a post-harvest
fumigant for crops established under the Federal Food, Drug, and
Cosmetic Act (FFDCA) (67 FR 16027, April 4, 2002) (FRL-6833-3).
In 1989, the Food and Drug Administration (FDA) banned methylene
chloride as an ingredient in all cosmetic products because of its
animal carcinogenicity and likely hazard to human health under the
FFDCA (54 FR 27328, June 29, 1989). Before 1989, methylene chloride had
been used in aerosol cosmetic products, such as hairspray (Ref. 61).
6. Significant Alternatives to the Proposed Rule
As discussed further in Unit V.A.4. and the IRFA, EPA considered--
in addition to the prohibition and WCPP that are proposed--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. The Agency determined that
some methods either did not effectively address the unreasonable risk
presented by methylene chloride or there was uncertainty in conditions
of use that would be less able to comply with a comprehensive WCPP to
adequately protect potentially exposed persons. The primary alternative
regulatory action was considered and found to provide greater
uncertainty in addressing the unreasonable risk from methylene chloride
under the conditions of use.
As required by the RFA section 609(b), EPA also convened a SBAR
Panel to obtain advice and recommendations from small entity
[[Page 28339]]
representatives that potentially would be subject to the rule's
requirements. The SBAR Panel evaluated the assembled materials and
small-entity comments on issues related to elements of an IRFA. The
panel recommended EPA include certain requests for comment, which can
be found in Unit VIII. (number 3.a through 3.k) and summarized in the
Initial Regulatory Flexibility Assessment (Ref. 27). The full SBAR
Panel Report is in the rulemaking docket (Ref. 6).
D. Unfunded Mandates Reform Act (UMRA)
This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for
State, local and Tribal governments, in the aggregate, or the private
sector in any one year. Accordingly, the EPA has prepared a written
statement required under UMRA section 202. The statement is included in
the docket for this action and briefly summarized here.
EPA estimates the compliance costs of the proposed rule to the
private sector to be approximately to be $13.2 million annualized over
20 years at a 3% discount rate and $14.5 million annualized over 20
years at a 7% discount rate. However, the costs of the rule to the
private sector are difficult to completely quantify. EPA's upper-bound
estimate for the potential economic impact of the proposed rule on
firms subject to the proposed prohibition on the use of methylene
chloride in commercial furniture refinishing involves a worst-case
assumption that all of as many as 5,000 furniture refinishing firms
will fully close due to the proposed prohibition.
As described in more detail in Units I.E. VI.D.2. and Tables 3-1
and 6-12 of the Economic Analysis (Ref. 3), EPA estimates the upper-
bound economic impact of potential closures of affected furniture
refinishing firms using methylene chloride following this rulemaking to
be $1.8 billion in total lost revenue, and $67 million in terms of the
total lost profit, under the assumption that all affected firms fully
close due to the proposed restrictions on methylene chloride. Thus, the
Agency concludes that cost of the rule to the private sector may exceed
the inflation-adjusted UMRA threshold of $100 million in any one year.
Nevertheless, the economic impact of a regulation on the national
economy is generally considered to be measurable only if the economic
impact of the regulation reaches 0.25 percent to 0.5 percent of GDP
(Ref. 58). Given the current GDP of $23.17 trillion, this is equivalent
to a cost of $58 billion to $116 billion. Therefore, EPA has concluded
that this rule is highly unlikely to have any measurable effect on the
national economy. Additional information on EPA's estimates of the
benefits and costs of this action are provided in Units I.E. and
VI.D.2., and in the Economic Analysis for this action (Ref. 3).
Information on the authorizing legislation is provided in Unit I.B.
Information on prior consultations with affected State, local, and
Tribal governments is provided in Unit III.A.1.
This action is not subject to the requirements of UMRA section 203
because it contains no regulatory requirements that might significantly
or uniquely affect small governments.
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. As
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA
section 6(a) to address the unreasonable risks presented by a chemical
substance has the potential to trigger preemption of laws, criminal
penalties, or administrative actions by a State or political
subdivision of a State that are: (1) Applicable to the same chemical
substance as the rule under TSCA section 6(a); and (2) Designed to
prohibit or otherwise restrict the manufacture, processing, or
distribution in commerce or use of that same chemical. TSCA section
18(c)(3) applies that preemption only to the ``hazards, exposures,
risks, and uses or conditions of use'' of such chemical included in the
final TSCA section 6(a) rule.
EPA provides the following preliminary federalism summary impact
statement. The Agency consulted with State and local officials early in
the process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included 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. 22). As discussed in Unit III.A.1., during Federal 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 SDWA. (Ref. 22). 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.
Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, EPA consulted with Tribal officials during the
development of this action. The Agency held a Tribal consultation from
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. 23). 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. 23). EPA received no written comments as part of this
consultation.
[[Page 28340]]
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because 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. Accordingly, this action's health and risk
assessments are contained in Units III.A.3., III.B.2., and V.A., as
well as in the 2020 Risk Evaluation for Methylene Chloride, and the
Economic Analysis for this proposed rulemaking (Refs. 1, 3).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy.
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 proposes not to require the use of
specific, prescribed analytic methods. Rather, the Agency plans to
allow the use of any method that meets the prescribed performance
criteria. The PBMS approach is intended to be more flexible and cost-
effective for the regulated community; it is also intended to encourage
innovation in analytical technology and improved data quality. EPA is
not precluding the use of any method, whether it constitutes a
voluntary consensus standard or not, as long as it meets the
performance criteria specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
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. 11). EPA recognizes that there may be
voluntary consensus standards that meet the proposed criteria (Ref.
62). EPA requests comments on whether it should incorporate such
voluntary consensus standards in the rule and seeks information in
support of such comments regarding the availability and applicability
of voluntary consensus standards that may achieve the sampling and
analytical requirements of the rule in lieu of the PBMS approach.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or Indigenous
peoples) and low-income populations.
EPA believes that the human health and environmental conditions
that exist prior to this action do not result in disproportionate and
adverse effects on people of color, low-income populations, and/or
Indigenous peoples. The documentation for this decision is contained in
the Economic Analysis (Ref. 3), which is in the public docket for this
action. As part of the Economic Analysis for this rulemaking, EPA
conducted an environmental justice analysis using information about the
facilities, workforce, and communities potentially affected by the
regulatory options under current conditions, before the proposed
regulation would goes 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 intent of the analysis was to
characterize the baseline conditions faced by communities and workers
to identify the potential for disproportionate impacts on minority and
low-income populations.
EPA believes that this action is not likely to result in new
disproportionate and adverse effects on people of color, low-income
populations and/or Indigenous peoples. However, while this regulatory
action would apply requirements to the extent necessary so that
methylene chloride no longer presents an unreasonable risk, EPA is not
able to quantify the distribution of the change in risk across affected
workers, communities, or demographic groups due to data limitations
that prevented EPA from conducting a more comprehensive analysis of
such a change.
EPA additionally identified and addressed environmental justice
concerns by conducting outreach to advocates of communities that might
be subject to disproportionate exposure to methylene chloride, such as
minority populations, low-income populations, and Indigenous peoples.
On November 16 and 19, 2020, EPA held public meetings as part of
this consultation. (Ref. 51). See also Unit III.A.1. These meetings
were held pursuant to and in compliance with Executive Order 12898 and
Executive Order 14008, Tackling the Climate Crisis at Home and Abroad
(86 FR 7619, February 1, 2021). EPA received three written comments
following the EJ meetings, in addition to oral comments provided during
the consultations (Refs. 24, 25, 26). 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 Units II.D., III.A.1., and VI.A., and well as in the Economic
Analysis (Ref. 3, 51). EPA's presentations, a summary of EPA's
presentation and public comments made, and fact sheets for the
environmental justice 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.
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
[[Page 28341]]
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.
0
2. Amend Sec. 751.5 by adding in alphabetical order definitions for
``authorized person'', ``ECEL'', ``EPA STEL'', ``owner or operator'',
``potentially exposed person'', ``regulated area'', and ``retailer'' to
read as follows:
Sec. 751.5 Definitions
* * * * *
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
* * * * *
ECEL is an Existing Chemical Exposure Limit, which is an EPA
regulatory limit on workplace exposure to an airborne concentration of
a chemical substance, generally based on an eight (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.
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
* * * * *
Potentially exposed person means any person who may be
occupationally exposed to a chemical substance or mixture in a
workplace as a result of a condition of use of that chemical substance
or mixture.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the ECEL or the EPA 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.
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.
0
4. Amend Sec. 751.103 by adding in alphabetical order a definition for
``ECEL'' to read as follows:
Sec. 751.103 Definitions.
* * * * *
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).
* * * * *
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 in subpart B and add new
Sec. 751.107 in subpart B to read as follows:
Sec. 751.107 Other prohibitions of manufacturing (including import),
processing, distribution in commerce, and use.
(a) Applicability. (1) The provisions of this section apply 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) The provisions of this section apply to all manufacturing
(including import), processing, and distribution in commerce of
methylene chloride for industrial or commercial use, and to all
commercial or industrial use of methylene chloride, other than the
conditions of use addressed under Sec. 751.109(a).
(b) Prohibitions. (1) After [DATE 90 DAYS AFTER DATE OF PUBLICATION
OF FINAL RULE IN THE FEDERAL REGISTER], 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 paragraph (b)(7) of this section.
(2) After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], all persons are prohibited from processing
methylene chloride, including any methylene chloride-containing
products for the uses listed in paragraphs (a)(1) and (2) of this
section except for those uses specified in paragraph (b)(7) of this
section.
(3) After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], all persons are prohibited from distributing in
commerce methylene chloride, including any methylene chloride-
containing products, to retailers for any use.
(4) After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], all retailers are prohibited from distributing
in commerce (including making available) methylene chloride, including
any methylene chloride-containing products, for any use.
(5) After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], 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 paragraph (b)(7) of this section.
(6) After [DATE 450 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], 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 paragraph (b)(7) of this
section.
(7) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN
THE FEDERAL REGISTER], 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 or coating removal
from safety critical, corrosion-sensitive components of aircraft or
spacecraft as described in Sec. 751.115(b)(1) through (3).
Sec. 751.109 [Redesignated as Sec. 751.113]
0
7. Redesignate Sec. 751.109 as new Sec. 751.113 in subpart B and add
new Sec. 751.109 in subpart B to read as follows:
Sec. 751.109 Workplace Chemical Protection Program.
(a) Applicability. The provisions of this section apply to the
following
[[Page 28342]]
conditions of use of methylene chloride, 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 that are owned or operated by the U.S. Department of
Defense, the National Aeronautics and Space Administration, the U.S.
Department of Homeland Security, and the Federal Aviation
Administration that is performed by the agency or the agency's
contractor at locations controlled by the agency or the agency's
contractor.
(9) 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
applications that are performed by the U.S. Department of Defense, the
National Aeronautics and Space Administration, or the U.S. Department
of Homeland Security or their contractors at locations controlled by
the agency or the agency's contractor; and
(10) Disposal;
(b) Relationship to 29 CFR part 1910. For purposes of this section:
(1) Any provisions applying to ``employee'' in 29 CFR 1910.1020, 29
CFR 1910.132, 29 CFR 1910.134, and 29 CFR 1910.1052 also apply equally
to potentially exposed persons; and
(2) Any provisions applying to ``employer'' in 29 CFR 1910.1020, 29
CFR 1910.132, 29 CFR 1910.134, and 29 CFR 1910.1052 also apply equally
to any owner or operator for the regulated area.
(c) Exposure limits. The owner or operator must ensure the
following:
(1) Existing Chemical Exposure Limit (ECEL). 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.
(2) EPA short-term exposure limit (EPA STEL). 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.
(3) Regulated areas. Owners or operators must establish and
maintain regulated areas in accordance with 29 CFR 1910.1052(e)(2),
(4), (5), (6), and (7), within 3 months after receipt of the results of
any monitoring data as outlined in paragraph (d) of this section.
Owners or operators must 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.
(d) Exposure monitoring--(1) In general--(i) Characterization of
exposures. Owners or operators must determine each potentially exposed
person's exposure 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 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.
(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. (i) After [DATE 180 DAYS AFTER DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] each owner or
operator of a workplace where methylene chloride is present must
perform an initial exposure monitoring to determine each potentially
exposed person's exposure, except under the following temporary
conditions:
(A) An owner or operator can provide EPA with objective data
generated during the last 5 years 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
(B) 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.
(ii) An owner or operator must re-conduct an initial exposure
monitoring at least once every 5 years if methylene chloride is present
in the workplace.
(3) Periodic monitoring. Where the initial exposure monitoring
shows exposure at or above the ECEL action level at or above the EPA
STEL, the owner or operator must establish an exposure monitoring
program for periodic monitoring of exposure to methylene chloride in
accordance with table 1 to this paragraph (d)(3).
[[Page 28343]]
Table 1 to Sec. 751.109(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 monitoring
concentration is below the ECEL action not required.
level and at or below the EPA STEL.
If the initial exposure monitoring ECEL monitoring not required,
concentration is below the ECEL action and EPA STEL monitoring
level and above the EPA STEL. required every 3 months.
If the initial exposure monitoring ECEL monitoring every 6 months.
concentration is at or above the ECEL
action level and at or below the ECEL;
and at or below the EPA STEL.
If the initial exposure monitoring ECEL monitoring every 6 months
concentration is at or above the ECEL and EPA STEL monitoring every
action level and at or below the ECEL; 3 months.
and above the EPA STEL.
If the initial exposure monitoring ECEL monitoring every 3 months
concentration is above the ECEL and and EPA STEL monitoring every
below, at, or above the EPA STEL. 3 months.
Two consecutive monitoring events have Reduce ECEL periodic monitoring
taken place 7 days apart that indicate frequency from every 3 months
that potential exposure has decreased to every 6 months.
from above the ECEL to at or below the
ECEL, but at or above the ECEL action
level.
Two consecutive monitoring events have Transition from ECEL periodic
taken place 7 days apart that indicate monitoring frequency from of
that potential exposure has decreased every 6 months to initial
to below the ECEL action level and at monitoring once every 5 years.
or below the EPA STEL. The second consecutive
monitoring event will
delineate the new date from
which the next 5-year initial
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.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
discussed paragraph (d)(4).
(4) Additional monitoring. The owner or operator must conduct an
additional initial exposure monitoring immediately 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.
(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 in plain language;
(C) Explanation of any corresponding required respiratory
protection as described in paragraph (f);
(D) Descriptions of actions taken by the owner or operator to
reduce exposure;
(E) Quantity of methylene chloride in use;
(F) Location of methylene chloride use;
(G) Manner of methylene chloride use;
(H) Identified releases of methylene chloride; and
(I) Whether the airborne concentration of methylene chloride
exceeds the ECEL or the EPA STEL.
(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.
(e) ECEL control procedures and plan--(1) Method of compliance.
After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
FEDERAL REGISTER], the owner or operator must institute and maintain
the effectiveness of engineering controls and work practices 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. Wherever the feasible engineering controls and work practices
which can be instituted are not sufficient to reduce exposures for
potentially exposed person to or below the ECEL or EPA STEL, the owner
or operator must use them to reduce exposure to the lowest levels
achievable by these controls and must supplement them by the use of
respiratory protection that complies with the requirements of paragraph
(f) of this section to reduce exposures to or below the ECEL or EPA
STEL. Wherever engineering controls and work practices are not
feasible, the owner or operator must use respiratory protection that
complies with the requirements of paragraph (f) of this section to
reduce exposures for potentially exposed persons to or below the ECEL
or EPA STEL. Where an owner or operator cannot demonstrate the use of
engineering controls or work practices that result in exposure below
the ECEL or EPA STEL, and has not demonstrated that it has supplemented
the risk of exposure with respiratory protection, this will constitute
a failure to comply with the ECEL. Additionally, the owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(2) Exposure control plan requirements. After [DATE 360 DAYS AFTER
DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], the owner
or operator must include and document in an exposure control plan the
following:
(i) Identification of exposure controls and rationale for using or
not using exposure controls in the following sequence--elimination,
substitution,
[[Page 28344]]
engineering controls, and administrative controls--to reduce exposures
in the workplace to either at or below the ECEL or EPA STEL or to the
lowest level achievable, and the exposure controls selected based on
feasibility, effectiveness, and other relevant considerations;
(ii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(iii) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(iv) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
using them accordingly;
(v) 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; and
(vi) Objective data generated during the previous 5 years, when
used to forgo the initial exposure monitoring, must include: the use of
methylene chloride being evaluated, the source of objective data,
measurement methods, measurement results, and measurement analysis of
the use of methylene chloride, and any other relevant data to the
operations, processes, or person's exposure.
(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 [DATE
270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER] 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 paragraph
(d)(1)(iii)) and as specified in this paragraph 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-certified 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-certified Supplied-Air Respirator (SAR) or airline
respirator in a demand mode equipped with a full facepiece (APF 50); or
(B) Any NIOSH-certified 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-certified Supplied-Air Respirator (SAR) or airline
respirator in a continuous-flow mode equipped with a full facepiece or
certified helmet/hood (APF 1,000); or
(B) Any NIOSH-certified Supplied-Air Respirator (SAR) or airline
respirator in pressure-demand or other positive-pressure mode equipped
with a full facepiece (APF 1,000); or
(C) Any NIOSH-certified 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.
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person to access the
exposure control plan and other associated records.
(g) Dermal protection. (1) 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), 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
8. Revise newly redesignated Sec. 751.111 to read as follows:
Sec. 751.111 Downstream notification.
(a) After August 26, 2019, and before [DATE 150 DAYS AFTER DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for each person who
manufactures (including imports), and before [DATE 210 DAYS AFTER DATE
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for each person
who 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 [DATE 150 DAYS AFTER DATE OF PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], each person who manufactures (including
import) methylene chloride for any use must, prior to or concurrent
with the shipment, notify companies to whom
[[Page 28345]]
methylene chloride is shipped, in writing, of the restrictions
described in this subpart in accordance with paragraph (d) of this
section.
(c) Beginning on [DATE 210 DAYS AFTER DATE OF PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER], 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 August 26, 2019, this chemical/product is not and cannot
be distributed in commerce or processed for consumer paint or
coating removal. After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF
FINAL RULE IN THE FEDERAL REGISTER] this chemical/product cannot be
distributed in commerce to retailers for any use. After [DATE 360
DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER], this chemical/product is and can only be processed or
distributed in commerce 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 acrylic and polycarbonate in mission-critical military and
space vehicle applications, including in the production of specialty
batteries for such applications that are performed by the U.S.
Department of Defense, the National Aeronautics and Space
Administration, or the Department of Homeland Security or their
contractors at locations controlled by the agency or the agency's
contractor; (7) Industrial or commercial use for paint and coating
removal from safety-critical, corrosion-sensitive components of
aircraft and spacecraft that are owned or operated by the U.S.
Department of Defense, the National Aeronautics and Space
Administration, the U.S. Department of Homeland Security, and the
Federal Aviation Administration that is performed by the agency or
the agency's contractor at locations controlled by the agency or the
agency's contractor; (8) Industrial or commercial use for paint and
coating removal from safety critical, corrosion-sensitive components
of other aircraft or spacecraft until [DATE 10 YEARS AFTER DATE OF
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]; and (9)
Disposal.
0
9. 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, 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 monitoring records. Owners or operators are required
to retain monitoring records in accordance with 29 CFR 1910.1052(m)(2)
Additionally, for each monitoring event of methylene chloride required
under this subpart, owners or operators must document the following:
(1) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(2) The identity of 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;
(3) Use of established analytical methods;
(4) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792; and
(5) Information regarding air monitoring equipment including: type,
maintenance, calibrations, performance tests, limits of detection, and
any malfunctions.
(c) Exposure control records. Owners or operators must retain
records of:
(i) Exposure control plan as described in Sec. 751.109(e)(2);
(ii) Regulated areas and authorized personnel;
(iii) Facility exposure monitoring records;
(iv) Notifications of exposure monitoring results;
(v) Personal protective equipment (PPE) and respiratory protection
used by potentially exposed persons and program implementation,
including fit-testing; and
(vi) Information and training provided pursuant to subsection (i)
of this section.
(d) Records related to Sec. 751.115 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.
(e) Minimum record retention period. The records required under
paragraphs (a) through (c) of this section must be retained for at
least 5 years from the date that such records were generated.
0
10. Add Sec. 751.115 to subpart B to read as follows:
Sec. 751.115 Exemptions.
(a) In general. (1) Time-limited exemptions as described in
paragraphs (b)(1) through (3) of this section provided for through
Sec. 751.107(b)(7) are established in this section in accordance with
15 U.S.C. 2605(g)(1)(B).
(2) Time-limited exemptions as described in paragraph (b)(4) of
this section are established in this section in accordance with 15
U.S.C. 2605(g)(1)(A).
(3) In order to be eligible for the exemptions established in this
section, regulated parties must comply with all conditions established
for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Time-limited exemptions. (1) 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 until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL
RULE IN THE FEDERAL REGISTER]. The following are specific conditions of
this exemption:
(i) The paint or coating removal must be performed on the premises
of maintenance or repair facilities operated by air carriers or
commercial operators certificated under 14 CFR part 119 or at repair
stations certificated under 14 CFR part 145, if their primary business
is performing maintenance, preventive maintenance, rebuilding, or
alteration of aircraft operated by air carriers and commercial
operators certificated under 14 CFR part 119.
(ii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the Workplace
Chemical Protection Program provisions in Sec. 751.109.
(iii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the recordkeeping
requirements in Sec. 751.113.
(2) Paint and coating removal from safety-critical, corrosion-
sensitive components of aircraft intended for, or suitable for
operation by, air carriers and commercial operators certificated under
14 CFR part 119 until [DATE 10 YEARS AFTER DATE OF
[[Page 28346]]
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]. The following are
specific conditions of this exemption:
(i) The paint or coating removal must be performed at locations
owned or operated by the manufacturer of the aircraft.
(ii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the Workplace
Chemical Protection Program provisions in Sec. 751.109.
(iii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the recordkeeping
requirements in Sec. 751.113.
(3) Paint and coating removal from safety-critical, corrosion-
sensitive components of spacecraft used in, or intended for use in,
commercial space transportation operations subject to 14 CFR chapter
III, including payloads such as satellites and similar hardware, until
[DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER]. The following are specific conditions of this exemption:
(i) The paint or coating removal must be performed at locations
owned or operated by the manufacturer of the spacecraft or payload or
similar hardware.
(ii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the Workplace
Chemical Protection Program provisions in Sec. 751.109.
(iii) The owner or operator of the location where the paint or
coating removal is being performed must comply with the recordkeeping
requirements in Sec. 751.113.
(4) Use of methylene chloride or methylene chloride-containing
products identified in paragraph (b)(4)(i) of this section in an
emergency by the National Aeronautics and Space Administration and its
contractors operating within the scope of their contracted work until
[DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL
REGISTER].
(i) Applicability. The emergency use exemption described in this
paragraph (b)(4) shall apply to the following specific conditions of
use as described in paragraphs (b)(4)(i)(A)(1) through (7) of this
section.
(A) Conditions of use subject to this exemption:
(1) Industrial and commercial use as solvent for cold cleaning
(2) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner
(3) Industrial and commercial use in adhesives, sealants and caulks
(4) Industrial and commercial use in adhesive and caulk removers
(5) Industrial and commercial use in metal non-aerosol degreasers
(6) Industrial and commercial use in non-aerosol degreasers and
cleaners
(7) Industrial and commercial use as solvent that becomes part of a
formulation or mixture
(B) Emergency use:
(1) In general. An emergency is a serious and sudden situation
requiring immediate action, within 15 days or less, necessary to
protect:
(i) Safety of National Aeronautics and Space Administration's or
their contractors' personnel;
(ii) National Aeronautics and Space Administration's missions;
(iii) Human health, safety, or property, including that of adjacent
communities; or
(iv) The environment.
(2) 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 National Aeronautics and Space Administration or its
contractors.
(ii) Requirements. To be eligible for the emergency use exemption
described in this paragraph (b)(4), National Aeronautics and Space
Administration and its contractors must comply with the following
conditions:
(A) Notification. Within 15 days of the emergency use by National
Aeronautics and Space Administration and its contractors, National
Aeronautics and Space Administration must provide notice to EPA that
includes the following:
(1) Identification of the conditions of use detailed in paragraph
(b)(4)(i)(A) of this section that the emergency use fell under;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(4)(i)(B) 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 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.
[FR Doc. 2023-09184 Filed 5-2-23; 8:45 am]
BILLING CODE 6560-50-P