Proposed Rule2023-09184
Methylene Chloride; Regulation Under the Toxic Substances Control Act (TSCA)
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Published
May 3, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#e6ab83928e9f8a838883a58e8a89948f8283b2b5a5a7a6839687c8818990"><span class="__cf_email__" data-cfemail="236e46574b5a4f464d46604b4f4c514a474677706062634653420d444c55">[email protected]</span></a>;
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#51050212107c193e253d383f34113421307f363e27"><span class="__cf_email__" data-cfemail="2f7b7c6c6e0267405b4346414a6f4a5f4e01484059">[email protected]</span></a>.
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:
<bullet> Other Chemical and Allied Products Merchant Wholesalers (NAICS
code 424690);
<bullet> Crude Petroleum Extraction (NAICS code 211120);
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199);
<bullet> Other Chemical and Allied Products Merchant Wholesalers (NAICS
code 424690);
<bullet> Petroleum Bulk Stations and Terminals (NAICS code 424710);
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180);
<bullet> Testing Laboratories (NAICS code 541380);
<bullet> Hazardous Waste Treatment and Disposal (NAICS code 562211);
<bullet> Solid Waste Combustors and Incinerators (NAICS code 562213);
<bullet> Materials Recovery Facilities (NAICS code 562920);
<bullet> Paint and Coating Manufacturing (NAICS code 325510);
<bullet> Air and Gas Compressor Manufacturing (NAICS code 333912);
<bullet> Gasket, Packing, and Sealing Device Manufacturing (NAICS code
339991);
<bullet> Residential Remodelers (NAICS code 236118);
<bullet> Commercial and Institutional Building Construction (NAICS code
236220);
<bullet> Plumbing, Heating, and Air-Conditioning Contractors (NAICS
code 238220);
<bullet> Painting and Wall Covering Contractors (NAICS code 238320);
<bullet> All Other Miscellaneous Manufacturing (NAICS code 339999);
<bullet> Automotive Parts and Accessories Stores (NAICS code 441310);
<bullet> All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS code 453998);
<bullet> Other Support Activities for Air Transportation (NAICS code
488190);
<bullet> All Other Automotive Repair and Maintenance (NAICS code
811198);
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
<bullet> Footwear and Leather Goods Repair (NAICS code 811430);
<bullet> Adhesive Manufacturing (NAICS code 325520);
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998);
<bullet> Audio and Video Equipment Manufacturing (NAICS code 334310);
<bullet> Reupholstery and Furniture Repair (NAICS code 811420);
<bullet> All Other Rubber Product Manufacturing (NAICS code 326299);
<bullet> All Other Miscellaneous Textile Product Mills (NAICS code
314999);
<bullet> All Other Miscellaneous Fabricated Metal Product Manufacturing
(NAICS code 332999);
<bullet> Oil and Gas Field Machinery and Equipment Manufacturing (NAICS
code 333132);
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<bullet> Bare Printed Circuit Board Manufacturing (NAICS code 334412);
<bullet> Other Electronic Component Manufacturing (NAICS code 334419);
<bullet> All Other Miscellaneous Electrical Equipment and Component
Manufacturing (NAICS code 335999);
<bullet> Printing Machinery and Equipment Manufacturing (NAICS code
333244);
<bullet> Petroleum Refineries (NAICS code 324110);
<bullet> Petroleum Lubricating Oil and Grease Manufacturing (NAICS code
324191);
<bullet> Painting and Wall Covering Contractors (NAICS code 238320);
<bullet> Welding and Soldering Equipment Manufacturing (NAICS code
333992);
<bullet> New Car Dealers (NAICS code 441110);
<bullet> Used Car Dealers (NAICS code 441120);
<bullet> Drycleaning and Laundry Services (except Coin-Operated) (NAICS
code 812320); and
<bullet> 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
[[Page 28286]]
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
[[Page 28287]]
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)
[[Page 28288]]
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<SUP>-3</SUP>
(E<SUP>-3</SUP>) at that exposure level. EPA used a benchmark of 1 in
10,000 (10<SUP>-4</SUP>) 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<SUP>-3</SUP> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Prohibit or otherwise restrict the manufacturing
(including import), processing, or distribution in commerce of the
substance or mixture, or limit the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce
(section 6(a)(1)).
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(section 6(a)(2)).
<bullet> Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(section 6(a)(2)).
<bullet> Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(section 6(a)(3)).
<bullet> Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (section 6(a)(4)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (section 6(a)(5)).
<bullet> Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (section 6(a)(6)).
<bullet> Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (section 6(a)(7)).
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
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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<SUP>-6</SUP>, which is lower than
the occupational benchmark for cancer risk of 1 x 10<SUP>-4</SUP> 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
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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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> 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.
<bullet> 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).
<bullet> 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).
<bullet> 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:
<bullet> Exposure control plan;
<bullet> Regulated areas and authorized personnel;
<bullet> Facility exposure monitoring records;
<bullet> Notifications of exposure monitoring results;
<bullet> PPE and respiratory protection used and program
implementation; and
<bullet> 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:
<bullet> 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;
<bullet> Situations in which selective coating removal is needed,
e.g., the preservation of a conversion coating;
<bullet> Effective removal of oven-cured paints and coatings;
<bullet> Localized removal of coatings on overhaul or rework parts
to reveal part markings and serial numbers;
<bullet> Stripping of parts preceding non-destructive testing,
where other coating removal methods such as media blasting could hide
defects; and
<bullet> 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]]
[…truncated; see source link]Indexed from Federal Register on May 3, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.