[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 28284-28346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09184]



[[Page 28283]]

Vol. 88

Wednesday,

No. 85

May 3, 2023

Part V





Environmental Protection Agency





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40 CFR Part 751





Methylene Chloride; Regulation Under the Toxic Substances Control Act 
(TSCA); Proposed Rule

  Federal Register / Vol. 88 , No. 85 / Wednesday, May 3, 2023 / 
Proposed Rules  

[[Page 28284]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0465; FRL-8155-02-OCSPP]
RIN 2070-AK70


Methylene Chloride; Regulation Under the Toxic Substances Control 
Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to 
address the unreasonable risk of injury to human health presented by 
methylene chloride under its conditions of use as documented in EPA's 
June 2020 Risk Evaluation for Methylene Chloride and November 2022 
revised risk determination for methylene chloride prepared under the 
Toxic Substances Control Act (TSCA). TSCA requires that EPA address by 
rule any unreasonable risk of injury to health or the environment 
identified in a TSCA risk evaluation and apply requirements to the 
extent necessary so that the chemical no longer presents unreasonable 
risk. Methylene chloride, also known as dichloromethane, is acutely 
lethal, a neurotoxicant, a likely human carcinogen, and presents cancer 
and non-cancer risks following chronic exposures as well as acute 
risks. Central nervous system depressant effects can result in loss of 
consciousness and respiratory depression, resulting in irreversible 
coma, hypoxia, and eventual death, including 85 documented fatalities 
from 1980 to 2018, a majority of which were occupational fatalities 
(see Unit II.A.). Nevertheless, methylene chloride is still a widely 
used solvent in a variety of consumer and commercial applications 
including adhesives and sealants, automotive products, and paint and 
coating removers. To address the identified unreasonable risk, EPA is 
proposing to: prohibit the manufacture, processing, and distribution in 
commerce of methylene chloride for consumer use; prohibit most 
industrial and commercial uses of methylene chloride; require a 
workplace chemical protection program (WCPP), which would include a 
requirement to meet inhalation exposure concentration limits and 
exposure monitoring for certain continued conditions of use of 
methylene chloride; require recordkeeping and downstream notification 
requirements for several conditions of use of methylene chloride; and 
provide certain time-limited exemptions from requirements for uses of 
methylene chloride that would otherwise significantly disrupt national 
security and critical infrastructure.

DATES: Comments must be received on or before July 3, 2023. Under the 
Paperwork Reduction Act, comments on the information collection 
provisions are best assured of consideration if the Office of 
Management and Budget (OMB) receives a copy of your comments on or 
before June 2, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0465, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Ingrid Feustel, Existing 
Chemicals Risk Management Division, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number 202-564-3199; email 
address: [email protected];
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by the proposed action if you 
manufacture (defined under TSCA to include import), process, distribute 
in commerce, use, or dispose of methylene chloride or products 
containing methylene chloride. The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
include:

 Other Chemical and Allied Products Merchant Wholesalers (NAICS 
code 424690);
 Crude Petroleum Extraction (NAICS code 211120);
 All Other Basic Organic Chemical Manufacturing (NAICS code 
325199);
 Other Chemical and Allied Products Merchant Wholesalers (NAICS 
code 424690);
 Petroleum Bulk Stations and Terminals (NAICS code 424710);
 Other Basic Inorganic Chemical Manufacturing (NAICS code 
325180);
 Testing Laboratories (NAICS code 541380);
 Hazardous Waste Treatment and Disposal (NAICS code 562211);
 Solid Waste Combustors and Incinerators (NAICS code 562213);
 Materials Recovery Facilities (NAICS code 562920);
 Paint and Coating Manufacturing (NAICS code 325510);
 Air and Gas Compressor Manufacturing (NAICS code 333912);
 Gasket, Packing, and Sealing Device Manufacturing (NAICS code 
339991);
 Residential Remodelers (NAICS code 236118);
 Commercial and Institutional Building Construction (NAICS code 
236220);
 Plumbing, Heating, and Air-Conditioning Contractors (NAICS 
code 238220);
 Painting and Wall Covering Contractors (NAICS code 238320);
 All Other Miscellaneous Manufacturing (NAICS code 339999);
 Automotive Parts and Accessories Stores (NAICS code 441310);
 All Other Miscellaneous Store Retailers (except Tobacco 
Stores) (NAICS code 453998);
 Other Support Activities for Air Transportation (NAICS code 
488190);
 All Other Automotive Repair and Maintenance (NAICS code 
811198);
 Commercial and Industrial Machinery and Equipment (except 
Automotive and Electronic) Repair and Maintenance (NAICS code 811310);
 Footwear and Leather Goods Repair (NAICS code 811430);
 Adhesive Manufacturing (NAICS code 325520);
 All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS code 325998);
 Audio and Video Equipment Manufacturing (NAICS code 334310);
 Reupholstery and Furniture Repair (NAICS code 811420);
 All Other Rubber Product Manufacturing (NAICS code 326299);
 All Other Miscellaneous Textile Product Mills (NAICS code 
314999);
 All Other Miscellaneous Fabricated Metal Product Manufacturing 
(NAICS code 332999);
 Oil and Gas Field Machinery and Equipment Manufacturing (NAICS 
code 333132);

[[Page 28285]]

 Bare Printed Circuit Board Manufacturing (NAICS code 334412);
 Other Electronic Component Manufacturing (NAICS code 334419);
 All Other Miscellaneous Electrical Equipment and Component 
Manufacturing (NAICS code 335999);
 Printing Machinery and Equipment Manufacturing (NAICS code 
333244);
 Petroleum Refineries (NAICS code 324110);
 Petroleum Lubricating Oil and Grease Manufacturing (NAICS code 
324191);
 Painting and Wall Covering Contractors (NAICS code 238320);
 Welding and Soldering Equipment Manufacturing (NAICS code 
333992);
 New Car Dealers (NAICS code 441110);
 Used Car Dealers (NAICS code 441120);
 Drycleaning and Laundry Services (except Coin-Operated) (NAICS 
code 812320); and
 Doll, Toy, and Game Manufacturing (NAICS code 339930).

    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final TSCA section 6(a) 
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements and the corresponding regulations at 19 Code 
of Federal Regulations (CFR) 12.118 through 12.127; see also 19 CFR 
127.28. Those persons must certify that the shipment of the chemical 
substance complies with all applicable rules and orders under TSCA. The 
EPA policy in support of import certification appears at 40 CFR part 
707, subpart B. In addition, any persons who export or intend to export 
a chemical substance that is the subject of this proposed rule are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.
    If you have any questions regarding the applicability of this 
proposed action to a particular entity, consult the technical 
information contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the U.S. 
Environmental Protection Agency, hereinafter EPA or ``the Agency,'' 
determines through a TSCA section 6(b) risk evaluation that a chemical 
substance presents an unreasonable risk of injury to health or the 
environment, EPA must by rule apply one or more requirements listed in 
section 6(a) to the extent necessary so that the chemical substance or 
mixture no longer presents such risk.

C. What action is the Agency taking?

    Pursuant to TSCA section 6(b), EPA determined that methylene 
chloride presents an unreasonable risk of injury to health, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to potentially exposed or susceptible subpopulations 
identified as relevant to the 2020 Risk Evaluation for Methylene 
Chloride by EPA, under the conditions of use (Refs. 1, 2). A detailed 
description of the conditions of use that drive EPA's determination 
that methylene chloride presents an unreasonable risk is included in 
Unit III.B.2. Accordingly, to address the unreasonable risk, EPA is 
proposing, under TSCA section 6(a) to:
    (i) Prohibit the manufacture, processing, and distribution of 
methylene chloride for all consumer use, as outlined in Unit IV.A.3.;
    (ii) Prohibit most industrial and commercial use of methylene 
chloride, as outlined in Unit IV.A.2.;
    (iii) Require a WCPP, including inhalation exposure concentration 
limits and related workplace exposure monitoring and exposure controls, 
for ten conditions of use of methylene chloride (including manufacture; 
processing as a reactant; laboratory use; industrial or commercial use 
in aerospace and military paint and coating removal from safety-
critical, corrosion-sensitive components by Federal agencies and their 
contractors; industrial or commercial use as a bonding agent for 
acrylic and polycarbonate in mission-critical military and space 
vehicle applications, including in the production of specialty 
batteries for such by Federal agencies and their contractors; and 
disposal), as outlined in Unit IV.A.1.;
    (iv) Require recordkeeping and downstream notification requirements 
for manufacturing, processing, and distribution in commerce of 
methylene chloride, as outlined in Unit IV.A.4.;
    (v) Provide a 10-year time-limited exemption under TSCA section 
6(g) for civilian aviation from the prohibition addressing the use of 
methylene chloride for paint and coating removal to avoid significant 
disruptions to critical infrastructure, as outlined in Unit IV.A.5., 
with conditions for this exemption to include compliance with the WCPP 
described in Unit IV.A.1.; and
    (vi) Provide a 10-year time-limited exemption under TSCA section 
6(g) for emergency use of methylene chloride in furtherance of National 
Aeronautics and Space Administration's mission for specific conditions 
which are critical or essential and for which no technically and 
economically feasible safer alternative is available, as outlined in 
Unit IV.A.5., with conditions for this exemption to include compliance 
with the WCPP described in Unit IV.A.1.
    EPA notes that all TSCA conditions of use of methylene chloride 
(other than the use of methylene chloride in consumer paint and coating 
removers, which was subject to separate action under TSCA section 6 (84 
FR 11420, March 27, 2019)) are subject to this proposal. Condition of 
use is defined in TSCA to mean the circumstances under which a chemical 
substance is intended, known, or reasonably foreseen to be 
manufactured, processed, distributed in commerce, used, or disposed of. 
EPA is requesting public comment on all aspects of this proposal.

D. Why is the Agency taking this action?

    Under TSCA section 6(a), ``[i]f the Administrator determines in 
accordance with subsection (b)(4)(A) that the manufacture, processing, 
distribution in commerce, use or disposal of a chemical substance or 
mixture, or that any combination of such activities, presents an 
unreasonable risk of injury to health or the environment, the 
Administrator shall by rule. . . apply one or more of the [section 
6(a)] requirements to such substance or mixture to the extent necessary 
so that the chemical substance no longer presents such risk.'' 
Methylene chloride was the subject of a risk evaluation under TSCA 
section 6(b)(4)(A) that was issued in June 2020 (2020 Risk Evaluation 
for Methylene Chloride) (Ref. 1). In addition, EPA issued a revised 
unreasonable risk determination for methylene chloride in November 2022 
(Ref. 2) determining that methylene chloride, as a whole chemical 
substance, presents an unreasonable risk of injury to health under the 
conditions of use. As a result, EPA is proposing to take action to the 
extent necessary so that methylene chloride no longer presents such 
risk. The unreasonable risk is described in Unit III.B.1. and the 
conditions of use that drive the unreasonable risk for methylene 
chloride are described in Unit III.B.2.
    EPA emphasizes that some of the adverse effects from methylene 
chloride exposure can be immediately experienced and only for a short 
duration; others, however, can result in sudden death. Other effects 
may result in long-term impacts and should likewise be considered 
significant. Methylene chloride's hazards are well established. 
Fatalities from acute methylene chloride exposures have

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been documented and pose a serious public health threat; these 
fatalities led the agency to prohibit the manufacture, processing, and 
distribution of methylene chloride for use in consumer paint and 
coating removers in 2019 (84 FR 11420, March 27, 2019) (FRL-9989-29). 
This proposed rule would eliminate the unreasonable risk to human 
health from the remaining conditions of use of methylene chloride, as 
identified in the 2020 Risk Evaluation for Methylene Chloride and the 
revised unreasonable risk determination for methylene chloride in 
November 2022.
    EPA is not proposing a complete ban on methylene chloride. The 
agency recognizes that continued use of methylene chloride in one of 
the TSCA conditions of use may complement the agency's efforts to 
address climate-damaging hydrofluorocarbons (HFCs) under the American 
Innovation and Manufacturing Act of 2020 (AIM Act), thereby supporting 
human health and environmental protection under these programs, and 
that, for these HFC-related, reactant processing uses, workplace 
controls to address unreasonable risk can be implemented. Therefore, 
while addressing the unreasonable risk, this rule proposes to allow 
methylene chloride's continued use in tandem with additional worker 
protections for the production of HFC-32, one of the regulated 
substances that are subject to a phasedown under the AIM Act. While 
HFC-32 is one of the regulated substances subject to the phasedown in 
production and consumption by 85% over the next 15 years, HFC-32 is 
likely to be used to facilitate the transition from certain other HFCs 
and HFC blends with higher global warming potentials in certain 
applications. EPA expects that, by allowing for the continued use of 
methylene chloride in the production of HFC-32, this approach would 
complement EPA's work under the AIM Act. For many of the conditions of 
use for which EPA is proposing workplace controls under a WCPP, data 
was submitted during the risk evaluation and Small Business Advocacy 
Review (SBAR process that indicates some facilities may already be in 
compliance with the proposed methylene chloride Existing Chemical 
Exposure Limit (ECEL). Additionally, the requirements in this proposal 
would prohibit uses that account for approximately one third of the 
total annual production volume of methylene chloride generated (TSCA 
and non-TSCA uses), leaving a sufficient supply in circulation to 
provide a source for these critical or essential uses for which EPA is 
proposing to allow continued use (Unit IV.A.), either under a WCPP or 
through a TSCA section 6(g) exemption (Ref. 3).

E. What are the estimated incremental impacts of this Action?

    EPA has prepared an Economic Analysis of the potential incremental 
impacts associated with this rulemaking that can be found in the 
rulemaking docket (Ref. 3). As described in more detail in the Economic 
Analysis (Ref. 3) and in Units VI.D. and X.D., EPA's analysis of the 
incremental, non-closure-related costs of this proposed rule is 
estimated to be $13.2 million annualized over 20 years at a 3% discount 
rate and $14.5 million annualized over 20 years at a 7% discount rate. 
These costs take compliance with implementation of a WCPP for certain 
conditions of use into consideration, which would include an ECEL of 2 
ppm (8 mg/m\3\) for inhalation exposures as an 8-hour time-weighted 
average (TWA), applicable personal protective equipment (PPE) 
requirements, and reformulation costs of numerous products. In addition 
to the monetized costs discussed previously there are unknown economic 
impacts of potential firm closures in the furniture refinishing 
industry as discussed in the Economic Analysis. Potential average lost 
profits range from $14,000 (one firm closing) to $67 million under the 
extreme and unlikely assumption of a complete sector shutdown (Ref. 3). 
EPA had also received comments following SBAR meetings where submitted 
exposure measurements indicated an ability to achieve ECEL levels, 
suggesting that a WCPP for certain uses is achievable; this is further 
discussed in Unit V.A.1. Unquantified costs exist, including 
determining the best substitute for the firm's specific needs and how a 
different product may impact a firm's existing workflow (e.g., does a 
different adhesive take longer to dry) and how a firm may work through 
the hierarchy of controls to comply with a WCPP. Although some costs 
cannot be quantified, they are not necessarily less important than the 
quantified costs. The most notable unquantified cost is change in labor 
and wait times within applications for which methylene chloride use is 
more efficient than substitute methods or alternative chemicals for 
achieving desired results. Additionally, in the unique case of 
furniture refinishing (within the commercial paint and coating removal 
condition of use), alternatives to products containing methylene 
chloride may not be economically viable and may cause damage to the 
substrate, and thus the prohibition of this use could impact the sector 
significantly. After publication of the proposed rule for methylene 
chloride in paint and coating removal (82 FR 7464, January 19, 2017) 
(FRL-9958-57), EPA, in collaboration with the Small Business 
Administration's Office of Advocacy, conducted a workshop on furniture 
refinishing in Boston, Massachusetts, on September 12, 2017 (82 FR 
41256, August 30, 2017) (FRL-9966-83) to address information gaps for 
the furniture refinishing sector identified in that proposed rule. The 
workshop was well attended by over 100 furniture refinishing experts, 
industry professionals, nongovernmental organizations, academic 
experts, and State and Federal Government partners (Ref. 4). The 
informative discussion among the participants and invited speakers 
touched on the commercial and consumer use of methylene chloride in 
furniture refinishing, the potential effects that regulation may have 
on businesses, alternatives to methylene chloride, health risks 
associated with methylene chloride, and labeling of consumer and 
commercial products (speaker presentations, transcript notes, and 
public comments are available in the docket EPA-HQ-OPPT-2017-0139).
    EPA estimates that as many as 5,000 furniture refinishers still use 
methylene chloride, a majority of which are small businesses. While the 
amount of methylene chloride paint removers used per firm for furniture 
refinishing can vary greatly, industry stakeholder information 
indicates one 55-gallon drum every two months (Ref. 4). This would 
result in an estimated 2.3 million gallons of formulated paint remover 
used annually. The amount of methylene chloride included in this 
estimate would depend on the percent in formulation used by the 
furniture refinishing firms. The impact of a prohibition of methylene 
chloride for furniture refinishing could result in the closure of an 
unknown number of the 5,000 potentially affected furniture refinishing 
firms using methylene chloride in the baseline.
    Based on the estimated revenues per firm presented in Table 3-1 of 
the Economic Analysis and the 5,000 estimated number of furniture 
refinishing firms using methylene chloride (see Table 6-12 in the 
Economic Analysis), the total revenue for furniture refinishing firms 
using methylene chloride is approximately $1.8 billion. According to 
IRS (2013) data, profit in this sector is about 3.8% of sales. 
Therefore, closure of affected furniture refinishing firms using 
methylene chloride following this

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rulemaking has an upper bound for economic impacts of $1.8 billion in 
total revenue, and $67 million in terms of the total profit, under the 
assumption that all affected firms fully close. A detailed discussion 
of potential economic impacts as a result of varying percentages of 
furniture refinishing firms closing is provided in the Economic 
Analysis in section 7.11 (Ref. 3).
    EPA identified many alternative products for paint and coating 
removers, though many may require longer periods of time, replacement 
of equipment, or rework of processes in order to work for furniture 
refinishing uses. These may not be appropriate alternatives as they 
could damage the wood substrate. Mechanical or thermal methods (i.e., 
sanding, media blasting, and heat guns) are also potential alternatives 
for this sector, though they likewise they require different processes, 
and often require more time (Refs. 3, 4, 5, 6). For furniture 
refinishing, as with other commercial uses, the health benefits that 
would result from prohibiting this use of methylene chloride, including 
deaths avoided, are further discussed in the Economic Analysis (Ref. 
3).
    The actions proposed in this rule are expected to achieve health 
benefits for the American public, some of which can be monetized and 
others that, while tangible and significant, cannot be monetized. 
Although some benefits cannot be quantified, they are not necessarily 
less important than the quantified benefits. The monetized benefits of 
this rule are approximately $17.7 million to $18.5 million annualized 
over 20 years at a 3% discount rate and $13.4 million to $13.9 million 
annualized over 20 years at a 7% discount rate. The monetized benefits 
only include potential reductions in risk of liver cancer, lung cancer, 
and potential deaths avoided from acute methylene chloride exposure. 
Non-monetized benefits include potential reductions in central nervous 
system depressant effects; these effects include loss of consciousness 
and respiratory depression that may result in irreversible coma and 
hypoxia. Risks from acute exposures to methylene chloride can lead to 
workplace accidents and are precursors to the more severe central 
nervous system effects (up to and including death). Other non-monetized 
benefits include reductions in liver disease (including vacuolization, 
necrosis, hemosiderosis and hepatocellular degeneration), immune system 
compromise, and irritation and burns (Ref. 3).

II. Background

A. Overview of Methylene Chloride

    Methylene chloride is acutely lethal, a neurotoxicant, and a likely 
human carcinogen. This proposed rule is specifically intended to 
address the unreasonable risk of injury to health that EPA has 
identified in the 2020 Risk Evaluation for Methylene Chloride and 
unreasonable risk determination, as described in Unit III.B.2. 
Methylene chloride is a colorless liquid and a volatile chemical with a 
sweet odor resembling chloroform. It is produced in and imported into 
the United States. Methylene chloride is manufactured, processed, 
distributed in commerce, used, and disposed of as part of many 
industrial, commercial, and consumer conditions of use. As outlined in 
Unit III.B.1., methylene chloride is a widely used solvent in a variety 
of consumer and commercial applications including adhesives and 
sealants, automotive products, and paint and coating removers. Some 
evidence suggests that in recent years, use of methylene chloride has 
been declining in certain sectors (Ref. 3), particularly for consumer 
products, as the hazards of methylene chloride are well known, and 
certain uses are highly regulated. As further described in Unit II.B. 
and in the regulatory appendix (Ref. 7), these regulations include 
EPA's 2019 rule addressing unreasonable risk to consumers from 
methylene chloride use in consumer paint and coating removal by 
prohibiting manufacturing, processing, and distribution in commerce of 
methylene chloride for consumer use in paint and coating removal (84 FR 
11420, March 27, 2019) (FRL-9989-29).
    The total aggregate production volume of methylene chloride ranged 
from 100 million to 500 million pounds between 2016 and 2019 according 
to Chemical Data Reporting (CDR) (Ref. 8). One notable high-volume use 
accounting for approximately one-fifth of all methylene chloride annual 
production volume is processing as a reactant, which includes the 
manufacture of hydrofluorocarbons (HFCs) (Ref. 1). This condition of 
use is described in Unit III.B.2., with a description of proposed 
requirements to address unreasonable risk in Unit III.B.3, and V.1. An 
estimated 35% of the annual production volume of methylene chloride is 
for pharmaceutical uses, which are not subject to TSCA and would not be 
regulated by this rule (15 U.S.C. 2602(2)(B)(vi); 21 U.S.C. 321(g)(1)).

B. Regulatory Actions Pertaining to Methylene Chloride

    Because of its adverse health effects, methylene chloride is 
subject to numerous State, Federal, and international regulations 
restricting and regulating its use. A summary of EPA regulations 
pertaining to methylene chloride, as well other Federal, State, and 
international regulations, is in the docket (Refs. 1, 7).

C. Consideration of Occupational Safety and Health Administration 
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA 
Risk Management Actions

    TSCA requires EPA to evaluate whether a chemical substance presents 
an unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant by the Administrator, under the conditions of 
use. Conditions of use are the circumstances, as determined by the 
Administrator, under which a chemical is intended, known, or reasonably 
foreseen to be manufactured, processed, distributed in commerce, used, 
or disposed of. If EPA determines through risk evaluation that a 
chemical substance presents an unreasonable risk, TSCA section 6 
requires EPA to issue regulations applying one or more control 
requirements to the extent necessary so that the chemical substance no 
longer presents such risk. Although EPA must consider, and in some 
cases factor-in, to the extent practicable, non-risk factors as part of 
TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must 
nonetheless still ensure that the selected regulatory requirements 
apply ``to the extent necessary so that the chemical substance or 
mixture no longer presents [unreasonable] risk.'' 15 U.S.C. 2605(a). 
This risk-based requirement is distinguishable from approaches mandated 
by other laws, including the Occupational Safety and Health Act (OSH 
Act), which includes both significant risk and feasibility (technical 
and economic) assessments in its rulemaking.
    Congress intended for EPA to consider occupational risks from 
chemicals it evaluates under TSCA, among other potential exposures, as 
relevant and appropriate. As noted previously, section 6(b) of TSCA 
requires EPA to evaluate risks to potentially exposed or susceptible 
subpopulations identified as relevant by the Administrator. TSCA 
section 3(12)

[[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

[[Page 28289]]

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.

[[Page 28290]]

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

[[Page 28291]]

the lowest observed adverse effects concentration (LOAEC) of 195 ppm. 
Adjusting to a more appropriate exposure duration of 8-hour for 
occupational scenarios resulted in a HEC of 80 ppm with benchmark MOE 
of 30. The resulting acute exposure limit is 16 ppm, eight times higher 
than the overall ECEL.
    The OSHA PEL for methylene chloride was adopted in 1971 and updated 
in 1997 (62 FR 1494, January 10, 1997). The OSHA PEL is set at 25 ppm, 
based on cancer from the same National Toxicology Program (1986) study 
cited for cancer effects in the 2020 Methylene Chloride Risk Evaluation 
(Ref. 14) (though EPA found this was not the most sensitive POD, and 
thus set an ECEL of 2 ppm, based on non-cancer liver effects from 
Nitschke et al., 1988 (Refs. 15, 16)).
    The OSHA PEL utilized a PBPK model to derive lifetime excess risk 
estimates for cancer. The PEL was set at 25 ppm based on estimated 
lifetime risk of 2.4 to 3.6 cases per 1000 or 2.4-3.66x10-3 
(E-3) at that exposure level. EPA used a benchmark of 1 in 
10,000 (10-4) for individuals in industrial and commercial 
work environments for purposes of the unreasonable risk determination 
for methylene chloride (Ref. 2), and at that cancer risk level EPA 
calculates the exposure limit based on cancer to be approximately 42 
ppm--almost double the OSHA PEL. OSHA acknowledges that the 
10-3 threshold is ``100 to 1000 times higher than the risk 
levels generally regarded by other Federal Agencies as on the boundary 
between significant and insignificant risk'' and notes that ``even at 
the final PELs, the risks to workers clearly remain significant.'' (62 
FR 1494, January 10, 1997).The 1997 decision to not derive a PEL lower 
than 25 ppm was based on economic and technical analysis, with OSHA 
stating, ``because of the lack of documented feasibility data for 
potential PELs of less than 25 ppm, OSHA has concluded that there is 
not enough information available to support lowering the 8-hour TWA PEL 
or STEL further at this time'' (62 FR 1494, January 10, 1997).
    As for non-cancer liver effects that are the basis of the ECEL, 
OSHA determined that ``chronic exposure to [methylene chloride] caused 
toxic effects in rat and mouse liver and cancer in mouse liver. These 
studies appear to have been well conducted and the differences in 
toxicity observed across studies were likely due to differences in dose 
or route of exposure . . . [L]imited evidence supports the hypothesis 
that [methylene chloride] causes human hepatotoxicity, based on the 
data in the Ott study. The remaining studies and case reports do not 
provide clear evidence of a causative role of [methylene chloride] in 
hepatotoxicity. The Agency [OSHA] has set the exposure limits based on 
cancer and [central nervous system] effects and has not reached final 
conclusions on this issue'' (62 FR 1514-1515, January 10, 1997). As 
discussed in Units II.D., III.B.A., and VII.D., the ECEL represents the 
best available science at time of publication of the 2020 Risk 
Evaluation for Methylene Chloride.

D. Summary of EPA's Risk Evaluation Activities on Methylene Chloride

    In July 2017, EPA published the scope of the methylene chloride 
risk evaluation (82 FR 31592, July 7, 2017) (FRL-9963-57), and, after 
receiving public comments, published the problem formulation in June 
2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In October 2019, EPA 
published a draft risk evaluation (84 FR 57866, October 29, 2019) (FRL-
9999-69), and, after public comment and peer review by the Science 
Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk 
Evaluation for Methylene Chloride in June 2020 in accordance with TSCA 
section 6(b) (85 FR 37942, June 24, 2020) (FRL-10011-16). EPA 
subsequently issued a draft revised TSCA risk determination for 
methylene chloride (87 FR 39824, July 5, 2022) (9946-01-OCSPP), and, 
after public notice and receipt of comments, published a Revised Risk 
Determination for Methylene Chloride in November 2022 (Ref. 2). The 
2020 Risk Evaluation for Methylene Chloride and supplemental materials 
are in docket EPA-HQ-OPPT-2019-0437, and the November 2022 revised 
unreasonable risk determination and additional materials supporting the 
risk evaluation process are in docket EPA-HQ-OPPT-2016-0742, on https://www.regulations.gov.
1. 2020 Risk Evaluation
    In the 2020 Risk Evaluation for Methylene Chloride, EPA evaluated 
risks associated with 53 conditions of use within the following 
categories: manufacture (including import), processing, distribution in 
commerce, industrial and commercial use, consumer use, and disposal 
(Ref. 1). Descriptions of these conditions of use are in Unit III.B.2. 
The 2020 Risk Evaluation for Methylene Chloride identified significant 
adverse health effects associated with short- and long-term exposure to 
methylene chloride, including central nervous system effects up to and 
including death from acute inhalation exposures, non-cancer liver 
effects from chronic inhalation, and cancer from chronic inhalation 
exposures to methylene chloride, as well as acute central nervous 
system effects and chronic non-cancer liver effects from dermal 
exposure. A further discussion of the hazards of methylene chloride is 
in Unit III.B.1.
2. 2022 Revised Unreasonable Risk Determination
    EPA has been revisiting specific aspects of its first ten TSCA 
existing chemical risk evaluations, including the methylene chloride 
risk evaluation, to ensure that the risk evaluations upon which risk 
management decisions are made better align with TSCA's objective of 
protecting health and the environment. For methylene chloride, EPA 
revised the original unreasonable risk determination based on the 2020 
Risk Evaluation for Methylene Chloride and issued a final revised 
unreasonable risk determination in November 2022 (Ref. 2). EPA revised 
the risk determination for the 2020 Risk Evaluation for Methylene 
Chloride pursuant to TSCA section 6(b) and consistent with Executive 
Order 13990, (``Protecting Public Health and the Environment and 
Restoring Science to Tackle the Climate Crisis'') and other 
Administration priorities (Refs. 17, 18, 19). The revisions consisted 
of making the risk determination based on the whole-chemical substance 
instead of by individual conditions of use (which resulted in the 
revised risk determination superseding the prior ``no unreasonable 
risk'' determinations (Ref. 2) the withdrawal of the associated TSCA 
section 6(i)(1) ``no unreasonable risk'' order; and clarifying that the 
risk determination does not reflect an assumption that all workers are 
always provided and appropriately wear PPE (Ref. 2).
    In determining whether methylene chloride presents unreasonable 
risk under the conditions of use, EPA considered relevant risk-related 
factors, including, but not limited to: the effects of the chemical 
substance on health (including cancer and non-cancer risks) and human 
exposure to the substance under the conditions of use (including 
duration, magnitude and frequency of exposure); the effects of the 
chemical substance on the environment and environmental exposure under 
the conditions of use; the population exposed (including any 
potentially exposed or susceptible subpopulations); the severity of 
hazard (including the nature of the hazard, the irreversibility of the 
hazard); and uncertainties.

[[Page 28292]]

    EPA determined that methylene chloride presents an unreasonable 
risk of injury to health. The unreasonable risk determination is driven 
by risks to workers and occupational non-users (workers who do not 
directly handle methylene chloride but perform work in an area where 
methylene chloride is present) from occupational exposures (i.e., 
during manufacture, processing, industrial and commercial uses, or 
disposal), and to consumers and bystanders from consumer use of 
methylene chloride. EPA did not identify risks of injury to the 
environment that drive the unreasonable risk determination for 
methylene chloride. The methylene chloride conditions of use that drive 
EPA's determination that the chemical substance poses unreasonable risk 
to health are listed in the unreasonable risk determination (Ref. 2) 
and also in Unit III.B.2., with descriptions to aid chemical 
manufacturers, processors, and users in determining how their 
particular use or activity would be addressed under the proposed 
regulatory provisions.
    While the 2020 Risk Evaluation for Methylene Chloride estimated 
different risks for occupational non-users and workers, the benchmark 
(and thus the ECEL and EPA STEL value) is the same for both 
populations. That is, while workers and occupational non-users may have 
different exposure patterns, the level of exposure such that risks are 
no longer unreasonable is the same for both workers and occupational 
non-users. Thus, for the purposes of risk management, the distinction 
between worker and occupational non-user is no longer relevant, and 
both are encompassed by the definition of a potentially exposed person, 
as outlined in Unit IV.A.1.a. EPA additionally emphasizes that the 
inclusion of occupational non-users itself does not exceed the scope of 
those individuals that are already covered by the OSHA PEL, as the 
methylene chloride OSHA standard applies to all employees within a 
regulated area, regardless of whether they directly handle methylene 
chloride.
3. Fenceline Screening Analysis
    The 2020 TSCA Risk Evaluation for Methylene Chloride excluded the 
assessment of certain exposure pathways that were or could be regulated 
under another EPA-administered statute (see section 1.4.2 of the 2020 
Risk Evaluation for Methylene Chloride (Refs. 1, 2)). This resulted in 
the surface water, drinking water, and ambient air pathways for 
methylene chloride exposure not being assessed for human health risk to 
the general population. In June 2021, EPA made a policy announcement on 
the path forward for TSCA chemical risk evaluations, indicating that 
EPA would, among other things, examine whether the exclusion of certain 
exposure pathways from the risk evaluations would lead to a failure to 
identify and protect fenceline communities (Refs. 10, 20).
    In order to assess the potential for risk to the general population 
in proximity to a facility releasing methylene chloride, EPA developed 
the TSCA Screening Level Approach for Assessing Ambient Air and Water 
Exposures to Fenceline Communities Version 1.0, which was presented to 
the SACC in March 2022, with a report issued by the SACC on May 18, 
2022 (Ref. 21). This analysis is discussed in Unit VI.A.

III. Regulatory Approach

A. Background

    Under TSCA section 6(a), if the Administrator determines, in 
accordance with TSCA section 6(b)(4)(A), that the manufacture 
(including import), processing, distribution in commerce, use, or 
disposal of a chemical substance or mixture, or any combination of such 
activities, presents an unreasonable risk of injury to health or the 
environment, EPA must by rule apply one or more of the following 
requirements to the extent necessary so that the chemical substance or 
mixture no longer presents such risk.
     Prohibit or otherwise restrict the manufacturing 
(including import), processing, or distribution in commerce of the 
substance or mixture, or limit the amount of such substance or mixture 
which may be manufactured, processed, or distributed in commerce 
(section 6(a)(1)).
     Prohibit or otherwise restrict the manufacturing, 
processing, or distribution in commerce of the substance or mixture for 
a particular use or above a specific concentration for a particular use 
(section 6(a)(2)).
     Limit the amount of the substance or mixture which may be 
manufactured, processed, or distributed in commerce for a particular 
use or above a specific concentration for a particular use specified 
(section 6(a)(2)).
     Require clear and adequate minimum warning and 
instructions with respect to the substance or mixture's use, 
distribution in commerce, or disposal, or any combination of those 
activities, to be marked on or accompanying the substance or mixture 
(section 6(a)(3)).
     Require manufacturers and processors of the substance or 
mixture to make and retain certain records or conduct certain 
monitoring or testing (section 6(a)(4)).
     Prohibit or otherwise regulate any manner or method of 
commercial use of the substance or mixture (section 6(a)(5)).
     Prohibit or otherwise regulate any manner or method of 
disposal of the substance or mixture, or any article containing such 
substance or mixture, by its manufacturer or processor or by any person 
who uses or disposes of it for commercial purposes (section 6(a)(6)).
     Direct manufacturers or processors of the substance or 
mixture to give notice of the unreasonable risk determination to 
distributors, certain other persons, and the public, and to replace or 
repurchase the substance or mixture (section 6(a)(7)).
    As described in Unit III.B., EPA assessed how the TSCA section 6(a) 
requirements could be applied to address the unreasonable risk found to 
be present in the 2020 Risk Evaluation for Methylene Chloride and the 
final revised unreasonable risk determination, so that methylene 
chloride no longer presents such unreasonable risk. EPA's proposed 
regulatory action and a primary alternative regulatory action are fully 
discussed in Unit IV. EPA is requesting public comment on the proposed 
regulatory action and primary alternative regulatory action.
    Under the authority of TSCA section 6(g), EPA may consider granting 
a time-limited exemption for a specific condition of use for which EPA 
finds that: (1) The specific condition of use is a critical or 
essential use for which no technically and economically feasible safer 
alternative is available, taking into consideration hazard and 
exposure; (2) Compliance with the requirement would significantly 
disrupt the national economy, national security, or critical 
infrastructure; or (3) The specific condition of use, as compared to 
reasonably available alternatives, provides a substantial benefit to 
health, the environment, or public safety. Further, the Administrator 
may by rule, extend, modify, or eliminate an exemption if the 
Administrator determines, on the basis of reasonably available 
information and after adequate public justification, the exemption 
warrants extension or modification or is no longer necessary. Based on 
reasonably available information, EPA has considered the issue and is 
proposing that a TSCA section 6(g) exemption is warranted for certain

[[Page 28293]]

conditions of use, as detailed in Unit IV.A.5. EPA is requesting 
comment on the proposed rule's section 6(g) exemption provisions and 
rationale.
    TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating 
section 6(a) rules, to consider and include a statement of effects 
addressing certain factors, including the costs and benefits and the 
cost effectiveness of the proposed regulatory action and of the one or 
more primary alternative regulatory actions considered by the 
Administrator. Also, under TSCA section 6(c)(2), EPA must consider the 
effects of the chemical substance or mixture on health or the 
environment and the magnitude of the exposure, which can include 
impacts to health or the environment in fenceline communities. TSCA 
section 6(c)(2) considerations are discussed in Unit VI.
    TSCA section 6(c)(2)(C) requires that, in deciding whether to 
prohibit or restrict in a manner that substantially prevents a specific 
condition of use and in setting an appropriate transition period for 
such action, EPA consider, to the extent practicable, whether 
technically and economically feasible alternatives that benefit health 
or the environment will be reasonably available as a substitute when 
the proposed prohibition or restriction takes effect. Unit III.B.4. 
includes more information regarding EPA's consideration of 
alternatives, and Unit V. provides more information on EPA's 
considerations more broadly under TSCA section 6(c)(2).
    As described in this Unit, EPA carried out required consultations 
as described later in this unit and also considered impacts on 
children's environmental health as part of its approach to developing 
this TSCA section 6 regulatory action.
1. Consultations
    EPA conducted consultations and outreach as part of development of 
this proposed regulatory action. The Agency held a federalism 
consultation from October 22, 2020, until January 23, 2021, as part of 
this rulemaking process and pursuant to Executive Order 13132. This 
included a background presentation on September 9, 2020, and a 
consultation meeting on October 22, 2020. During the consultation, EPA 
met with State and local officials early in the process of developing 
the proposed action in order to receive meaningful and timely input 
into its development (Ref. 22). During the consultation, participants 
and EPA discussed preemption, EPA's authority under TSCA section 6 to 
regulate identified unreasonable risk, what activities would be 
potentially regulated in the proposed rule, and the relationship 
between TSCA and existing statutes--particularly the Clean Water Act 
(CWA) and Safe Drinking Water Act (SDWA) (Ref. 22).
    Methylene chloride is not manufactured (including imported), 
processed, distributed in commerce, or regulated by Tribal governments. 
However, EPA consulted with Tribal officials during the development of 
this proposed action (Ref. 23). The Agency held a Tribal consultation 
from October 7, 2020, to January 8, 2021, with meetings on November 12 
and 13, 2020. Tribal officials were given the opportunity to 
meaningfully interact with EPA risk managers concerning the current 
status of risk management. During the consultation, EPA discussed risk 
management under TSCA section 6(a), findings from the 2020 Risk 
Evaluation for Methylene Chloride, types of information that would be 
helpful to inform risk management, principles for transparency during 
the risk management process, and types of information EPA is seeking 
from Tribes (Ref. 23). EPA received no written comments as part of this 
consultation.
    In addition to the formal consultations, EPA also conducted 
outreach to advocates for communities that might be subject to 
disproportionate exposure to methylene chloride, including 
underrepresented communities such as minority populations, low-income 
populations, and Indigenous peoples. EPA's Environmental Justice (EJ) 
consultation occurred from November 4, 2020, through January 18, 2021. 
On November 16 and 19, 2020, EPA held public meetings as part of this 
consultation. These meetings were held pursuant to and in compliance 
with Executive Orders 12898 and 14008. EPA received three written 
comments following the EJ meetings, in addition to oral comments 
provided during the consultations (Refs. 24, 25, 26). In general, 
commenters supported strong regulation of methylene chloride to protect 
lower-income communities and workers. Commenters supported strong 
outreach to affected communities, encouraged EPA to follow the 
hierarchy of controls in regulating methylene chloride, favored 
prohibitions, and noted the uncertainties associated with use of PPE 
(e.g., in some cases, use of PPE did not provide adequate protection 
given the exposure scenario).
    As required by section 609(b) of the Regulatory Flexibility Act 
(RFA), EPA convened a SBAR Panel to obtain advice and recommendations 
from Small Entity Representatives (SERs) that potentially would be 
subject to the rule's requirements. EPA met with SERs before and during 
Panel proceedings, on November 4, 2020, and January 28, 2021. Panel 
recommendations are in Unit X.C. and in the Initial Regulatory 
Flexibility Analysis (Ref. 27); the Panel report is in the docket (Ref. 
6).
    Units X.C., X.E., X.F., and X.J. provide more information regarding 
the consultations.
2. Other Stakeholder Consultations
    In addition to the formal consultations described in Unit X., EPA 
attended a Small Business Administration (SBA) Office of Advocacy 
Environmental Roundtable on September 11, 2020 and held a public 
webinar on September 16, 2020. At both events EPA staff provided an 
overview of the TSCA risk management process and the findings in the 
2020 Risk Evaluation for Methylene Chloride (Ref. 28). Attendees of 
these meetings were given an opportunity to voice their concerns 
regarding the risk evaluation and risk management.
    Furthermore, EPA has engaged in discussions with representatives 
from different industries, non-governmental organizations, technical 
experts, and users of methylene chloride. A list of external meetings 
held during the development of this proposed rule is in the docket 
(Ref. 29); meeting materials and summaries are also in the docket. The 
purpose of these discussions was to hear from users, academics, 
manufacturers, and members of the public health community about 
practices related to commercial and consumer uses of methylene 
chloride; public health impacts of methylene chloride; the importance 
of methylene chloride in the various uses subject to this proposed 
rule; frequently used substitute chemicals or alternative methods; 
engineering control measures and PPE currently in use or feasibly 
adoptable; and other risk-reduction approaches that may have already 
been adopted or considered for industrial, commercial or consumer uses.
3. Children's Environmental Health
    The Agency's 2021 Policy on Children's Health (Ref. 30) requires 
EPA to protect children from environmental exposures by consistently 
and explicitly considering early life exposures (from conception, 
infancy, and early childhood and through adolescence until 21 years of 
age) and lifelong health in all human health decisions through 
identifying and integrating children's health data and information when 
conducting risk assessments. TSCA section 6(b)(4)(A) also requires EPA 
to

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conduct risk evaluations ``to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment . 
. . including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant to the risk evaluation 
by the Administrator, under the conditions of use.'' In addition, TSCA 
section 6(a) requires EPA to apply one or more risk management 
requirements so that methylene chloride no longer presents an 
unreasonable risk (which includes unreasonable risk to any relevant 
potentially exposed or susceptible subpopulations).
    The 2020 Risk Evaluation for Methylene Chloride evaluated exposures 
of infants, toddlers, older children (11 to 15 years and 16 to 20 
years), and males and females of reproductive age; while EPA identified 
exposures to these populations (as bystanders, consumers, or workers) 
as driving the unreasonable risk for methylene chloride, EPA did not 
find that the adverse health impacts for these groups was 
disproportionate in comparison to other populations. While there is 
some evidence of an association between methylene chloride and 
developmental neurological effects, the literature contains 
methodological limitations in human studies and concentration 
limitations in animal studies, and thus reproductive/development 
effects were not carried forward to dose-response (Ref. 1).
    More specifically, the 2020 Risk Evaluation for Methylene Chloride 
released in June 2020 considered impacts on both children and adults 
from occupational and consumer use from inhalation and dermal 
exposures, as applicable. For occupational use, the risk evaluation 
considered males (>16 years of age) and females of reproductive age 
(>16 years of age to less than 50 years of age) for both dermal and 
inhalation exposures. For consumer use, EPA evaluated dermal exposures 
for children ages 11 to 15 and 16 to 20 years of age, and the 
evaluation of bystander exposure from inhalation exposures included 
infants, toddlers and older children. While risks to children are not 
disproportionate, effects observed in studies include central nervous 
system impairment from acute inhalation exposure and liver toxicity 
from chronic inhalation exposure. The risks described in this section 
would be addressed by the proposed regulatory action described in Unit 
IV.

B. Regulatory Assessment of Methylene Chloride

1. Description of Conditions of Use
    This Unit describes the TSCA conditions of use that drive the 
unreasonable risk for methylene chloride. Condition of use descriptions 
were obtained from EPA sources such as CDR use codes, the 2020 Risk 
Evaluation for Methylene Chloride and related documents, as well as the 
Organisation for Economic Co-operation and Development harmonized use 
codes, and stakeholder engagements. EPA acknowledges that some of the 
terms here may be defined under other statutes; however, the 
descriptions in this unit are intended to provide clarity to the 
regulated entities who will implement the provisions of this rulemaking 
under TSCA section 6(a).
a. Manufacturing (Includes Import)
i. Domestic Manufacturing
    This condition of use refers to manufacturing, or producing, a 
chemical substance within the United States (including manufacturing 
for export). Manufacture includes the extraction of a component 
chemical substance from a previously existing chemical substance or 
complex combination of chemical substances.
ii. Import
    This condition of use refers to the act of causing a chemical 
substance or mixture to arrive within the customs territory of the 
United States.
b. Processing
i. Processing as a Reactant
    This condition of use refers to processing methylene chloride in 
chemical reactions for the manufacturing of another chemical substance 
or product, e.g., difluoromethane, also known as HFC-32, which is used 
in fluorocarbon blends for refrigerants, and bis-2,2-dinitropropyl-
acetal/formal.
ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction 
Product
    This condition of use refers to when methylene chloride is added to 
a product (or product mixture) prior to further distribution of the 
product.
iii. Processing: Repackaging
    This condition of use refers to the preparation of methylene 
chloride for distribution in commerce in a different form, state, or 
quantity. This includes transferring the chemical from a bulk container 
into smaller containers.
iv. Processing: Recycling
    This condition of use refers to the process of treating generated 
waste streams(i.e., which would otherwise be disposed of as waste) that 
are collected, either on-site or transported to a third-party site, for 
commercial purpose. Waste solvents can be restored to a condition that 
permits reuse via solvent reclamation/recycling. The recovery process 
may involve an initial vapor recovery or mechanical separation step 
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Uses
i. Industrial and Commercial Use as Solvent for Batch Vapor Degreasing
    This condition of use refers to the process of heating methylene 
chloride to its volatilization point and using its vapor to remove 
dirt, oils, greases, and other surface contaminants (such as drawing 
compounds, cutting fluids, coolants, solder flux, and lubricants) from 
metal parts, electronics, or other articles in batch open-top vapor 
degreasers or closed-loop vapor degreasing in industrial or commercial 
settings.
ii. Industrial and Commercial Use as Solvent for In-line Vapor 
Degreasing
    This condition of use refers to the process of heating methylene 
chloride to its volatilization point and using its vapors to remove 
dirt, oils, greases, and other surface contaminants from textiles, 
glassware, metal surfaces, and other articles using conveyorized or 
continuous-web vapor degreasing machines in industrial or commercial 
settings.
iii. Industrial and Commercial Use as Solvent for Cold Cleaning
    This condition of use refers to the industrial or commercial use of 
methylene chloride as a non-boiling solvent in cold-cleaning to 
dissolve oils, greases, and other surface contaminants from textiles, 
glassware, metal surfaces, and other articles.
iv. Industrial and Commercial Use as Solvent for Aerosol Spray 
Degreaser/Cleaner
    This condition of use refers to industrial or commercial use of 
methylene chloride in aerosol degreasing as an aerosolized solvent 
spray, typically applied from a pressurized can, to remove residual 
contaminants from fabricated parts or machinery (including circuit 
boards and electronics).

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v. Industrial and Commercial Use in Adhesives, Sealants, and Caulks
    This condition of use refers to industrial or commercial use of 
methylene chloride in adhesives, sealants, and caulks to promote 
bonding between other substances, promote adhesion of surfaces, or 
prevent seepage of moisture or air.
vi. Industrial and Commercial Use in Paints and Coatings
    This condition of use refers to industrial or commercial use of 
methylene chloride in paints or coatings applied to surfaces, usually 
to enhance properties such as water repellency, gloss, fade resistance, 
ease of application, or foam prevention, etc.
vii. Industrial and Commercial Use in Paint and Coating Removers
    This condition of use refers to industrial or commercial use of 
methylene chloride or methylene chloride-containing products applied to 
surfaces to remove paint, coatings, and other finishes and to clean the 
underlying surface, including but not limited to furniture refinishing.
viii. Industrial and Commercial Use in Adhesive and Caulk Removers
    This condition of use refers to industrial or commercial use of 
methylene chloride in products in industrial or commercial settings 
applied to surfaces to unbind substances or remove sealants and to 
clean the underlying surface by softening adhesives, caulks, and other 
glues so they can be removed.
ix. Industrial and Commercial Use in Metal Aerosol Degreasers
    This condition of use refers to the industrial or commercial use of 
methylene chloride in aerosol degreasing as an aerosolized solvent 
spray, typically applied from a pressurized can, to remove residual 
contaminants from fabricated parts, machinery, or other metal 
substrate.
x. Industrial and Commercial Use in Metal Non-Aerosol Degreasers
    This condition of use refers to the industrial or commercial use of 
methylene chloride in liquid degreasing to remove residual contaminants 
from fabricated parts, machinery, or other metal substrate.
xi. Industrial and Commercial Use in Finishing Products for Fabric, 
Textiles, and Leather
    This condition of use refers to industrial or commercial use of 
methylene chloride in the finishing of fabrics at fabric or textile 
mills, including in products that impart color or other desirable 
properties to fabrics or textiles. The methylene chloride may be added 
during the manufacturing of the textile or during the finishing, such 
as pressing of the fabric.
xii. Industrial and Commercial Use in Automotive Care Products 
(Functional Fluids for Air Conditioners)
    This condition of use refers to the industrial or commercial use of 
methylene chloride for one or more operational properties in a closed 
system in products intended for automotive care and includes automotive 
air conditioner refrigerant and as a refrigerant with stop leak 
sealant.
xiii. Industrial and Commercial Use in Automotive Care Products 
(Interior Car Care)
    This condition of use refers to the industrial or commercial use of 
methylene chloride in cleaning agents used to remove stains from 
interior carpets and textiles in automotive vehicles.
xiv. Industrial and Commercial Use in Automotive Care Products 
(Degreasers)
    This condition of use refers to the industrial or commercial use of 
methylene chloride in liquid or aerosol degreasing to remove residual 
contaminants from automotive substrates and articles.
xv. Industrial and Commercial Use in Apparel and Footwear Care Products
    This condition of use refers to the industrial or commercial use of 
methylene chloride in apparel and footwear care products as post-market 
waxes, polishes, or other media and applied to footwear, textiles, or 
fabrics to impart color or other desirable properties.
xvi. Industrial and Commercial Use in Spot Removers for Apparel and 
Textiles
    This condition of use refers to the industrial or commercial use of 
methylene chloride or methylene chloride-containing products applied 
from squeeze bottles, hand-held spray bottles, or spray guns, either 
before or after a cleaning cycle on apparel and textiles. After 
application, the methylene chloride or product is removed by manually 
scraping or flushing away the stain by using a brush, spatula, 
pressurized air, or steam.
xvii. Industrial and Commercial Use in Liquid Lubricants and Greases
    This condition of use refers to the industrial or commercial use of 
methylene chloride in liquids that reduce friction, heat generation, 
and wear between surfaces.
xviii. Industrial and Commercial Use in Spray Lubricants and Greases
    This condition of use refers to the industrial or commercial use of 
methylene chloride in sprays that reduce friction, heat generation, and 
wear between surfaces.
xix. Industrial and Commercial Use in Aerosol Degreasers and Cleaners
    This condition of use refers to the industrial or commercial use of 
methylene chloride in aerosol degreasing as an aerosolized solvent 
spray, typically applied from a pressurized can, to remove residual 
contaminants from a fabricated part or other substrate.
xx. Industrial and Commercial Use in Non-Aerosol Degreasers and 
Cleaners
    This condition of use refers to the industrial or commercial use of 
methylene chloride in liquid degreasing to remove residual contaminants 
(such as oils, greases, and similar materials) from a fabricated part 
or other substrate (such as textiles, glassware, products, and other 
articles).
xxi. Industrial and Commercial Use in Cold Pipe Insulations
    This condition of use refers to the industrial or commercial use of 
methylene chloride when typically applied in aerosolized form in 
products used in building and construction materials to provide 
insulation.
xxii. Industrial and Commercial Use as a Solvent That Becomes Part of a 
Formulation or Mixture
    This condition of use refers to industrial or commercial use of 
methylene chloride added to a product (or product mixture) in an 
industrial or commercial setting.
xxiii. Industrial and Commercial Use as a Processing Aid
    This condition of use refers to the industrial or commercial use of 
methylene chloride to improve the processing characteristics or the 
operation of process equipment or to alter or buffer the pH of the 
substance or mixture, when added to a process or to a substance or 
mixture to be processed. Processing agents do not become a part of the 
reaction product and are not intended to affect the

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function of a substance or article created.
xxiv. Industrial and Commercial Use as Propellant and Blowing Agent
    This condition of use refers to the industrial or commercial use of 
methylene chloride in the production of polyurethane foam including as 
a blowing agent and as a solvent for cleaning equipment.
xxv. Industrial and Commercial Use as a Laboratory Chemical
    This condition of use refers to the industrial or commercial use of 
methylene chloride in a laboratory process or in specialized laboratory 
equipment for instrument calibration/maintenance chemical analysis, 
chemical synthesis, extracting and purifying other chemicals, 
dissolving other substances, executing research, development, test and 
evaluation methods, and similar activities. In response to a request 
for clarification, EPA agrees that use of methylene chloride in a 
closed-loop chiller system used to perform FAA-required aviation fuel 
testing is considered industrial and commercial use as a laboratory 
chemical (Ref. 31). The analogous use of methylene chloride in a 
chiller system in the Department of Defense McKinley Climactic 
Laboratory would likewise be considered industrial and commercial use 
as a laboratory chemical.
xxvi. Industrial and Commercial Use for Electrical Equipment, 
Appliance, and Component Manufacturing
    This condition of use refers to the industrial or commercial use of 
methylene chloride in electrical and electronic products; their 
maintenance; their manufacture, such as in the production of printed 
circuit boards; and at wholesalers and retail stores.
xxviii. Industrial and Commercial Use for Plastic and Rubber Products 
Manufacturing
    This condition of use refers to the industrial or commercial use of 
methylene chloride in the manufacture and processing of plastic and 
rubber products, including in interfacial polymerization for 
polycarbonate plastic manufacturing.
xxix. Industrial and Commercial Use in Cellulose Triacetate Film 
Production
    This condition of use refers to the industrial or commercial use of 
methylene chloride as a chemical processor for polycarbonate resins and 
cellulose triacetate (photographic film).
xxx. Industrial and Commercial Use as Anti-Spatter Welding Aerosol
    This condition of use refers to the industrial or commercial use of 
methylene chloride in formulations to prevent spatter from adhering to 
metal surfaces during welding.
xxxi. Industrial and Commercial Use for Oil and Gas Drilling, 
Extraction, and Support Activities
    This condition of use refers to the industrial or commercial use of 
methylene chloride in the extraction, development, and preparation of 
oil, liquid crude petroleum, and gas. Activities may include 
exploration for crude petroleum and natural gas, core sampling, 
drilling wells, operating separator, emulsion breakers, and distilling 
equipment.
xxxii. Industrial and Commercial Use for Toys, Playgrounds, and 
Sporting Equipment
    This condition of use refers to the industrial or commercial use of 
methylene chloride in the manufacture of toys intended for children's 
use (and child-dedicated articles), including fabrics, textiles, and 
apparel (which may include stuffed toys, blankets, or comfort objects) 
as well as plastic articles (hard) (which may include dolls, toy cars, 
toy animals, or teething rings).
xxxiii. Industrial and Commercial Use in Lithographic Printing Plate 
Cleaner
    This condition of use refers to the industrial or commercial use of 
methylene chloride in lithographic printing for the cleaning of plates 
and rollers.
xxxiv. Industrial and Commercial Use in Carbon Remover, Wood Floor 
Cleaner, and Brush Cleaner
    This condition of use refers to the industrial or commercial use of 
methylene chloride in formulated products to remove carbon and other 
dirt and residues from a variety of surfaces including floors and 
brushes.
d. Consumer Uses
i. Consumer Use as a Solvent in Aerosol Degreasers/Cleaners
    This condition of use refers to consumer use of products containing 
methylene chloride as a solvent for cleaning or degreasing in the form 
of an aerosol spray degreaser or cleaner. The products are used to 
dissolve oils, greases, and similar materials from textiles, glassware, 
metal surfaces, and other articles.
ii. Consumer Use in Adhesives and Sealants
    This condition of use refers to consumer use of methylene chloride 
in single or two-component products used to fasten other materials 
together or prevent the passage of liquid or gas.
iii. Consumer Use in Brush Cleaners for Paints and Coatings
    This condition of use refers to consumer use of products containing 
methylene chloride to clean brushes after using them to apply paints or 
coatings.
iv. Consumer Use in Adhesive and Caulk Removers
    This condition of use refers to consumer use of products containing 
methylene chloride to remove, loosen, or deteriorate any adhesive or 
caulk from a substrate, such as floor adhesive removal.
v. Consumer Use in Metal Degreasers
    This condition of use refers to consumer use of products containing 
methylene chloride for the degreasing of metals, such as coil cleaners 
and electronics cleaners.
vi. Consumer Use in Automotive Care Products (Functional Fluids for Air 
Conditioners)
    This condition of use refers to consumer use of products containing 
methylene chloride for automotive care and includes automotive air 
conditioner refrigerant and leak sealant.
vii. Consumer Use in Automotive Care Products (Degreasers)
    This condition of use refers to consumer use of products containing 
methylene chloride for automotive care and includes products for 
degreasing automotive parts, such as brakes, carburetors, engines, and 
gaskets.
viii. Consumer Use in Lubricants and Greases
    This condition of use refers to consumer use of products containing 
methylene chloride to reduce friction, heat generation, and wear 
between solid surfaces, such as engines and brakes.
ix. Consumer Use in Cold Pipe Insulation
    This condition of use refers to consumer use of products containing 
methylene chloride used in building and construction materials to 
provide insulation.

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x. Consumer Use in Arts, Crafts, and Hobby Materials Glue
    This condition of use refers to consumer use of arts, crafts, and 
hobby materials, such as glues, containing methylene chloride.
xi. Consumer Use in an Anti-Spatter Welding Aerosol
    This condition of use refers to consumer use of products containing 
methylene chloride to prevent the spatter of the welding from sticking 
to welding material or a nearby surface (for example, workbenches).
xii. Consumer Use in Carbon Removers and Other Brush Cleaners
    This condition of use refers to consumer use of products containing 
methylene chloride for cleaning applications to remove carbon, inks and 
paints, grease, or other foreign matter. The cleaning operations 
include carbon removers (for example, to clean appliances, pots, and 
pans) and other applications that usually involve the use of a brush 
(for example, in lithographic printing cleaners, in taxidermy, and in 
wood and floor cleaners).
e. Disposal
    This condition of use refers to the process of disposing generated 
waste streams of methylene chloride that are collected either on-site 
or transported to a third-party site for disposal.
f. Terminology in This Proposed Rule
    For the purposes of this proposed rulemaking, ``occupational 
conditions of use'' refers to the TSCA conditions of use described in 
Units III.B.1.a, b, c, and e. Although EPA identified both industrial 
and commercial uses in the 2020 Risk Evaluation for Methylene Chloride 
for purposes of distinguishing scenarios, the Agency clarified then and 
clarifies now that EPA interprets the authority Congress gave to the 
Agency to ``regulat[e] any manner or method of commercial use'' under 
TSCA section 6(a)(5) to reach both industrial and commercial uses.
    Additionally, in the 2020 Risk Evaluation for Methylene Chloride, 
EPA identified and assessed all known, intended, and reasonably 
foreseen industrial, commercial, and consumer uses of methylene 
chloride (other than the use of methylene chloride in consumer paint 
and coating removers, which was subject to separate action under TSCA 
section 6 (84 FR 11420, March 27, 2019)). EPA determined that all 
industrial, commercial, and consumer use of methylene chloride 
evaluated in the 2020 Risk Evaluation for Methylene Chloride drives the 
unreasonable risk of injury to health. As such, for purposes of this 
risk management rulemaking, ``consumer use'' refers to all known, 
intended, or reasonably foreseen methylene chloride consumer uses. 
Likewise, for the purpose of this risk management rulemaking, 
``industrial and commercial use'' refers to all known, intended, or 
reasonably foreseen methylene chloride industrial and commercial use.
    EPA further notes that this proposed rule does not apply to any 
substance excluded from the definition of ``chemical substance'' under 
TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but 
are not limited to, any pesticide (as defined by the Federal 
Insecticide, Fungicide, and Rodenticide Act) when manufactured, 
processed, or distributed in commerce for use as a pesticide; and any 
food, food additive, drug, cosmetic, or device, as defined in section 
201 of the Federal Food, Drug, and Cosmetic Act, when manufactured, 
processed, or distributed in commerce for use as a food, food additive, 
drug, cosmetic or device.
    EPA is not proposing to incorporate the descriptions in Units 
III.B.1.a through III.B.1.e. into the regulatory text as definitions. 
EPA requests comment on whether a definition should be promulgated for 
each condition of use of methylene chloride and, if so, whether the 
descriptions in this Unit are consistent with the conditions of use 
evaluated in the 2020 Risk Evaluation for Methylene Chloride and 
whether they provide a sufficient level of detail such that they would 
improve the clarity and readability of the regulation if promulgated.
2. Description of Unreasonable Risk Under the Conditions of Use
    EPA has determined that methylene chloride presents an unreasonable 
risk of injury to human health under the conditions of use based on 
acute and chronic non-cancer risks and chronic cancer risks. As 
described in the TSCA section 6(b) 2020 Risk Evaluation for Methylene 
Chloride, EPA identified non-cancer adverse effects from both acute and 
chronic inhalation and dermal exposures to methylene chloride, and 
cancer from chronic inhalation and dermal exposures to methylene 
chloride (Ref. 1). EPA identified neurotoxicity effects (central 
nervous system) as the most sensitive endpoint of the non-cancer 
adverse effects from acute inhalation and dermal exposures, and liver 
effects as the most sensitive endpoint of the non-cancer adverse 
effects from chronic inhalation and dermal exposures for all conditions 
of use. However, EPA also identified additional risks associated with 
other adverse effects (e.g., other nervous system effects, immune 
system effects, reproductive and developmental effects, and irritation/
burns) resulting from acute and chronic exposures. By targeting the 
sensitive chronic liver endpoint for risk management, EPA's action will 
also eliminate the unreasonable risks from acute, chronic non-cancer 
and cancer endpoints from methylene chloride. EPA also recognizes the 
severity of the risks from acute inhalation exposures to methylene 
chloride, because relatively small increases in acute exposure can lead 
to extreme adverse effects associated with central nervous system 
suppression, including coma and death. Occupational fatalities linked 
to methylene chloride have been recorded as recently as June 2020 (Ref. 
32). Eighty-five occupational fatalities between 1980 and 2018 have 
been documented from methylene chloride in paint and coating removal or 
adhesive and sealant use, and when methylene chloride is being used as 
a cleaning or degreasing solvent; there has been no linear trend 
indicating a decrease in fatalities during that time period (Ref. 32). 
In some instances, while workers were wearing respirators, the 
respirators were inadequate to protect against methylene chloride 
inhalation exposure (Ref. 32). Unit VI.A. summarizes the health effects 
and the magnitude of the exposures in more detail.
    To make the unreasonable risk determination for methylene chloride, 
EPA evaluated exposures to workers, occupational non-users, consumer 
users, and bystanders using reasonably available monitoring and 
modeling data for inhalation and dermal exposures. In addition, EPA 
conducted a screening level analysis to assess risks from the air and 
water pathways to fenceline communities. A discussion of EPA's analysis 
and the expected effects of this rulemaking on fenceline communities is 
in Unit VI.A.
    For the 2020 Risk Evaluation for Methylene Chloride, EPA considered 
potentially exposed or susceptible subpopulations identified as 
relevant to the risk evaluation by the Agency. There are several groups 
of individuals with greater exposure to methylene chloride relative to 
the general population, including: (1) Workers and occupational non-
users, and (2) Consumer users and bystanders to consumer use of 
products containing methylene chloride (Ref. 1). EPA also identified 
several human subpopulations which may have greater susceptibility than 
the general population to the hazards of methylene chloride, including 
individuals with

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certain genetic polymorphisms (variant forms of a specific DNA 
sequence) that may make them more susceptible to getting cancer from 
methylene chloride, and individuals with cardiac disease and other 
comorbidities, who may be at increased risk for angina from acute 
exposures (Ref. 1). All potentially exposed or susceptible 
subpopulations are included in the quantitative and qualitative 
analyses described in the 2020 Risk Evaluation for Methylene Chloride 
and were considered in the determination of unreasonable risk for 
methylene chloride. As discussed in Units II.D. and VI.A., the 2020 
Risk Evaluation for Methylene Chloride excluded the air and water 
exposure pathways from the published risk evaluations and may have 
caused some risks to be unaccounted for in the risk evaluation. EPA 
considers receptors exposed to methylene chloride through those 
pathways to constitute a subset of the general population and 
categorizes them as fenceline communities; they may also be considered 
potentially exposed or susceptible subpopulations. See Unit VI.A. for 
further discussion on assessing and protecting risk to fenceline 
communities.
3. Description of TSCA Section 6 Requirements for Risk Management
    EPA examined the TSCA section 6(a) requirements (listed in Unit 
III.A.) to identify which ones have the potential to eliminate the 
unreasonable risk from methylene chloride. This Unit summarizes the 
TSCA section 6 considerations for issuing regulations under TSCA 
section 6(a). Unit V. outlines how EPA applied these considerations 
specifically to managing the unreasonable risk from methylene chloride.
    As required, EPA developed a proposed regulatory action and one 
primary alternative regulatory action, which are described in Units 
IV.A. and IV.B., respectively. To identify and select a regulatory 
action, EPA considered the two routes of exposure driving the 
unreasonable risk, inhalation and dermal, and the exposed populations. 
For occupational conditions of use (see Unit III.B.1.f.), EPA 
considered how it could directly regulate manufacturing (including 
import), processing, distribution in commerce, industrial and 
commercial use, or disposal to address the unreasonable risk. EPA does 
not have direct authority to regulate consumer use. Therefore, EPA 
considered how it could exercise its authority under TSCA to regulate 
the manufacturing (including import), processing, and/or distribution 
in commerce of methylene chloride at different levels in the supply 
chain to eliminate exposures or restrict the availability of methylene 
chloride and methylene chloride-containing products for consumer use in 
order to address the unreasonable risk.
    As required by TSCA section 6(c)(2), EPA considered several 
factors, in addition to identified unreasonable risk, when selecting 
among possible TSCA section 6(a) requirements. To the extent 
practicable, EPA factored into its decisions: (i) the effects of 
methylene chloride on health and the environment, (ii) the magnitude of 
exposure to methylene chloride of human beings and the environment, 
(iii) the benefits of methylene chloride for various uses, and (iv) the 
reasonably ascertainable economic consequences of the rule. In 
evaluating the reasonably ascertainable economic consequences of the 
rule, EPA considered (1) The likely effect of the rule on the national 
economy, small business, technological innovation, the environment, and 
public health; (2) The costs and benefits of the proposed regulatory 
action and one or more primary alternative regulatory actions 
considered; and (3) The cost effectiveness of the proposed regulatory 
action and of the one or more primary alternative regulatory actions 
considered. TSCA section 6(c)(2)(A) considerations for methylene 
chloride are discussed in full in Unit VI., including the statement of 
effects of the proposed rule with respect to these considerations.
    EPA also considered regulatory authorities under statutes 
administered by other agencies such as the OSH Act, the Consumer 
Product Safety Act (CPSA), and the Federal Hazardous Substances Act 
(FHSA), as well as other EPA-administered statutes, to examine (1) 
Whether there are opportunities for all or part of this risk management 
action to be addressed under other statutes, such that a referral may 
be warranted under TSCA section 9(a) or 9(b); or (2) Whether TSCA 
section 6(a) regulation could include alignment of requirements and 
definitions in and under existing statutes and regulations to minimize 
confusion to the regulated entities and the general public.
    In addition, EPA followed other TSCA requirements such as 
considering the availability of alternatives when contemplating 
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as 
outlined in Unit III.B.4.), and setting proposed compliance dates in 
accordance with the requirements in TSCA section 6(d)(1)(B) (described 
in the proposed and alternative regulatory action in Unit IV.).
    To the extent information was reasonably available, EPA considered 
pollution prevention strategies and the hierarchy of controls adopted 
by OSHA and NIOSH, as discussed in Unit II.C.4., when selecting 
regulatory actions, with the goal of identifying risk management 
control methods that are permanent, feasible, and effective. EPA also 
considered how to address the unreasonable risk while providing 
flexibility to the regulated community where appropriate, and took into 
account the information presented in the 2020 Risk Evaluation for 
Methylene Chloride, as well as input from stakeholders (as described in 
Unit III.A.) and anticipated compliance strategies from regulated 
entities.
    Taken together, these considerations led EPA to the proposed 
regulatory action and primary alternative regulatory action described 
in Unit IV. Additional details related to how the requirements in this 
Unit were incorporated into development of those actions are in Unit V.
    As demonstrated by the number of distinct programs addressed in 
this rulemaking and the structure of this proposed rule in addressing 
them independently, EPA generally intends the rule's provisions to be 
severable from each other. EPA expects to provide additional detail on 
severability in the final rule once the Agency has considered public 
comments and finalized the regulatory language.

IV. Proposed Regulatory and Alternative Regulatory Actions

    This Unit describes the proposed regulatory action by EPA so that 
methylene chloride will no longer present an unreasonable risk of 
injury to health. In addition, as indicated by TSCA section 6(c)(2)(A), 
EPA must consider the costs and benefits and the cost-effectiveness of 
the proposed regulatory action and one or more primary alternative 
regulatory actions. In the case of methylene chloride, the proposed 
regulatory action is described in Unit IV.A. and the alternative 
regulatory action considered is described in Unit IV.B. An overview of 
the proposed regulatory action and primary alternative regulatory 
action for each condition of use is in Unit IV.C.

A. Proposed Regulatory Action

    EPA is proposing under TSCA section 6(a) to: Require a WCPP, 
including inhalation exposure concentration limits and related 
monitoring, for ten conditions of use, outlined in Unit IV.A.1.; 
Prohibit most industrial and commercial use of methylene chloride, 
outlined in Unit IV.A.2.; Prohibit the

[[Page 28299]]

manufacture, processing, and distribution in commerce of methylene 
chloride for all consumer use (other than the use of methylene chloride 
in consumer paint and coating removers, which was subject to separate 
action under TSCA section 6 (84 FR 11420, March 27, 2019), outlined in 
Unit IV.A.3.; Establish recordkeeping and downstream notification 
requirements, outlined in Unit IV.A.4.; and Provide a 10-year, time-
limited exemption under TSCA section 6(g) for paint and coating removal 
by civilian aviation from a prohibition that would significantly 
disrupt critical infrastructure, as outlined in Unit IV.A.5., with 
conditions for this exemption to include compliance with the WCPP 
described in Unit IV.A.1.
1. Workplace Chemical Protection Program (WCPP)
a. Overview
    As described in Unit I., under TSCA section 6(a), 15 U.S.C. 
2605(a), EPA is required to issue a regulation applying one or more of 
the TSCA section 6(a) requirements to the extent necessary so that the 
unreasonable risk of injury to human health or the environment from a 
chemical substance is no longer presented. The TSCA section 6(a) 
requirements provide EPA the authority to limit or prohibit a number of 
activities, including, but not limited to, restricting or regulating 
the manufacture, processing, distribution in commerce, commercial use, 
or disposal of the chemical substance. Given this statutory authority, 
EPA may find it appropriate in certain circumstances to propose a WCPP 
for certain occupational (i.e., industrial and commercial) conditions 
of use. A WCPP encompasses inhalation exposure thresholds, includes 
monitoring and recordkeeping requirements to verify that those 
thresholds are not exceeded, and may include other components, such as 
dermal protection, to ensure that the chemical substance no longer 
presents unreasonable risk. Under a WCPP, owners or operators have some 
flexibility, within the parameters outlined in this Unit, regarding how 
they prevent exceedances of the identified EPA exposure limit 
thresholds. In the case of methylene chloride, meeting the EPA exposure 
limit thresholds for certain occupational conditions of use would 
address the unreasonable risk to potentially exposed persons from 
inhalation exposure.
    EPA uses the term ``potentially exposed person'' in this Unit and 
in the regulatory text to include workers, occupational non-users, 
employees, independent contractors, employers, and all other persons in 
the work area where methylene chloride is present and who may be 
exposed to methylene chloride under the conditions of use for which a 
WCPP would apply. EPA's intention is to require a comprehensive WCPP 
that would address the unreasonable risk from methylene chloride to 
workers directly handling the chemical or in the area where the 
chemical is being used. Similarly, the 2020 Risk Evaluation for 
Methylene Chloride did not distinguish between employers, contractors, 
or other legal entities or businesses that manufacture, process, 
distribute in commerce, use, or dispose of methylene chloride. For this 
reason, EPA uses the term ``owner or operator'' to describe the entity 
responsible for implementing the WCPP in any workplace where an 
applicable condition of use described in Units III.B.1.a. through 
III.B.1.e. and subject to the WCPP is occurring. The term includes any 
person who owns, leases, operates, controls, or supervises such a 
workplace.
    EPA is proposing a WCPP for the following conditions of use: 
domestic manufacturing; import; processing as a reactant; processing 
for incorporation into a formulation, mixture, or reaction product; 
processing in repackaging; processing in recycling; industrial and 
commercial use as a laboratory chemical; industrial or commercial use 
for paint and coating removal from safety-critical, corrosion-sensitive 
components of aircraft and spacecraft by Federal agencies and their 
contractors; industrial or commercial use as a bonding agent for 
acrylic and polycarbonate in mission-critical military and space 
vehicle applications, including in the production of specialty 
batteries for such applications by Federal agencies and their 
contractors; and disposal (EPA's rationale is provided in Unit V.). EPA 
is additionally proposing to require that uses receiving an exemption 
under TSCA section 6(g), as outlined in Unit IV.A.5., comply with the 
WCPP. EPA is proposing that these requirements take effect 180 days 
after publication of the final rule, at which point entities would be 
required to conduct initial monitoring (as described in Unit 
IV.A.1.c.). Additionally, EPA would require the implementation of any 
needed exposure controls based on initial monitoring and development of 
an exposure control plan within 1 year of publication of the final rule 
(Unit IV.A.1.d.). EPA believes these timeframes are achievable because 
they are consistent with the timeframes in OSHA's 1997 standard for 
methylene chloride (62 FR 1494, January 10, 1997). EPA is requesting 
comment on these proposed implementation timeframes for the WCPP 
requirements.
    When considering and developing a WCPP that includes an ECEL, EPA 
coordinates and consults with other Federal agencies to achieve the 
maximum enforcement of TSCA while avoiding imposing duplicative 
requirements, consistent with TSCA section 9(d). For methylene 
chloride, EPA's streamlined approach for implementing the ECEL would 
seek to align with, to the extent possible, certain elements of the 
existing OSHA standard for regulating methylene chloride under 29 CFR 
1910.1052. The OSHA PEL, action level, STEL, and ancillary requirements 
have established a strong precedent for exposure limit threshold 
requirements within the regulated community. However, the existing PEL 
and STEL do not eliminate the unreasonable risk identified by EPA under 
TSCA, and EPA is therefore proposing to apply new, lower, exposure 
thresholds, derived from the TSCA 2020 Risk Evaluation for Methylene 
Chloride, while aligning with existing requirements wherever possible 
(Refs. 1, 11). For methylene chloride, this approach would eliminate 
the unreasonable risk driven by the conditions of use subject to the 
WCPP, enable continued industry use where appropriate, and provide the 
familiarity of a pre-existing framework for the regulated community.
    EPA's proposed requirements include specific exposure limits and 
ancillary requirements necessary for the ECEL's successful 
implementation as part of a WCPP. Taken together, these WCPP 
requirements would apply to the extent necessary so that the 
unreasonable risk driven by the conditions of use listed earlier in 
this Unit would no longer be presented. EPA's proposal would align with 
existing requirements from the OSHA methylene chloride standard at 29 
CFR 1910.1052 to the extent possible (also summarized in Unit V.A.). As 
discussed in Unit II.B.3., because the unreasonable risk driven by 
these occupational conditions of use cannot be addressed entirely 
through the continued application of the OSHA standard and associated 
requirements, EPA is proposing additional requirements for lower 
exposure limits, user notification, recordkeeping, periodic monitoring, 
and respirator selection criteria as part of the WCPP. EPA acknowledges 
that the values of the ECEL, the ECEL action level, and the EPA STEL, 
outlined in Unit IV.A.1.b., may mean that some entities that are

[[Page 28300]]

currently in compliance with the OSHA standard will have to increase 
the frequency and scope of their compliance activities in order to 
achieve compliance with the requirements being proposed in this action, 
such as through the implementation of engineering controls to reduce 
exposures to the extent feasible, periodic exposure monitoring 
frequency (Unit IV.A.1.c.iii.), establishment of regulated areas (Unit 
IV.A.1.d.), use of respiratory protection (Unit IV.A.1.e.ii.), and 
notification of monitoring results (Unit IV.A.1.f.ii.).
    This Unit includes a summary of the WCPP, including a description 
of proposed exposure limits including an ECEL, ECEL action level, and 
EPA STEL; proposed implementation requirements including monitoring 
requirements; a description of potential exposure controls, including 
engineering controls, administrative controls, and PPE as it relates to 
dermal protections and respirator selection; and additional 
requirements proposed for recordkeeping, workplace participation, and 
notification in accordance with the hierarchy of controls. This Unit 
also describes compliance timeframes for these proposed requirements.
b. Existing Chemical Exposure Limit (ECEL), EPA Action Level (AL), and 
Short-Term Exposure Limit (STEL)
    To reduce exposures in the workplace and address the inhalation 
exposures to methylene chloride for occupational conditions of use that 
drive to the unreasonable risk of injury to human health, EPA is 
proposing an ECEL under TSCA section 6(a) of 2 ppm (8 mg/m\3\) as an 8-
hour TWA based on the chronic non-cancer human equivalent concentration 
for liver toxicity. EPA has determined, as a matter of risk management 
policy, that ensuring exposures remain at or below the ECEL will 
eliminate the unreasonable risk of injury to health resulting from 
acute and chronic inhalation exposures for certain occupational 
conditions of use. EPA's description for how the requirements related 
to an ECEL would address the unreasonable risk driven by those 
occupational conditions of use and the rationale for the regulatory 
approach of a WCPP are in Unit V.A.
    If ambient exposures are kept at or below the 8-hour TWA ECEL of 2 
ppm and at or below the 15-minute TWA EPA STEL of 16 ppm, a potentially 
exposed person would be protected against the effects described in Unit 
III.B.3., including effects resulting from acute exposure (central 
nervous system depression), chronic non-cancer effects (liver 
toxicity), and cancer. As an example, the incremental individual cancer 
risk at the 8-hour ECEL is 5.1 x 10-6, which is lower than 
the occupational benchmark for cancer risk of 1 x 10-4 cited 
in the 2020 Risk Evaluation for Methylene Chloride and the NIOSH 
Chemical Carcinogen Policy (Ref. 33).
    EPA is also proposing to establish an ECEL action level at half of 
the 8-hour ECEL, or 1 ppm (4 mg/m\3\) as an 8-hour time-weighted 
average. The ECEL action level would be a definitive cut-off point 
below which certain compliance activities, such as periodic monitoring, 
would not be required as described further in this Unit. As explained 
by OSHA, an action level provides employers and employees with 
confidence that exposure reduction actions could be taken before 
inhalation exposure to methylene chloride exceeds the inhalation 
exposure limit (Ref. 34). EPA agrees with this reasoning and, like 
OSHA, expects the inclusion of an ECEL action level will stimulate 
innovation within industry to reduce exposures to methylene chloride to 
levels below the action level (Ref. 34). Therefore, EPA has identified 
a need for an action level for methylene chloride and is proposing a 
level that would be half the 8-hour ECEL, which is in alignment with 
the precedented approach established by OSHA (Ref. 34).
    In addition to the 8-hour TWA ECEL, EPA is proposing a STEL of 16 
ppm (57 mg/m\3\) as a 15-minute TWA. This short-term exposure limit is 
based on the non-cancer endpoint of central nervous system depression 
resulting from acute exposures. EPA has also determined, as a matter of 
risk management policy, that ensuring exposures remain at or below the 
EPA STEL will eliminate the unreasonable risk of injury to health 
driven by acute inhalation exposures in an occupational setting. EPA is 
proposing the EPA STEL for the protection of potentially exposed 
persons to methylene chloride for shorter durations and at higher 
concentrations that fall outside the parameters of the ECEL 8-hour 
time-weighted average. EPA is also proposing the EPA STEL in 
consideration of the severe and potentially irreversible hazards of 
such short-term exposures, which, as described in Unit II.B.2., can 
range from blurred vision to death.
    In summary, EPA is proposing that owners or operators must ensure 
the airborne concentration of methylene chloride within the personal 
breathing zone of potentially exposed persons remains at or below 2 ppm 
as an 8-hour TWA ECEL, with an action level identified as 1 ppm as an 
8-hour TWA. EPA is also proposing that owners or operators must ensure 
the airborne concentration of methylene chloride within the personal 
breathing zone of potentially exposed persons remains at or below a 15-
minute TWA, or EPA STEL, of 16 ppm. EPA is proposing the ECEL and EPA 
STEL for certain occupational conditions of use to ensure that no 
person is exposed to inhalation of methylene chloride in excess of 
these concentrations resulting from those conditions of use, thus 
eliminating the unreasonable risk of injury to human health driven by 
those conditions of use. For the identified conditions of use for which 
the concentration thresholds are being proposed, EPA expects that the 
regulated community has the ability to detect the values for the ECEL, 
ECEL action level, and EPA STEL because these limits are above the 
detection limits of methylene chloride monitoring devices that are 
widely available in commerce, currently in use, and approved by OSHA 
and NIOSH, which generally range from 0.2 to 0.4 ppm (Ref. 11). EPA's 
methodology and inputs for the ECEL and EPA STEL values is directly 
derived from the peer reviewed analysis in the 2020 Risk Evaluation for 
Methylene Chloride, which was also subject to public comment (Ref 13). 
As with all aspects of this rulemaking, the public is welcome to 
comment on the methodology for the ECEL and EPA STEL values.
    As discussed further in Unit V.A.1., for many of the conditions of 
use for which EPA is proposing a WCPP, data was submitted during the 
risk evaluation and SBAR process that indicates some facilities may 
already be in compliance with the proposed methylene chloride ECEL. As 
noted previously in this Unit, EPA expects that, if inhalation 
exposures for affected occupational conditions of use are kept at or 
below the ECEL and EPA STEL, potentially exposed persons reasonably 
likely to be exposed in the workplace would be protected from the 
unreasonable risk associated with covered occupational conditions of 
use. EPA is also proposing to require owners or operators to comply 
with additional requirements that would be needed to ensure successful 
implementation of the ECEL and EPA STEL.
c. Monitoring Requirements
i. In General
    Monitoring requirements are a key component of implementing EPA's 
proposed requirements for a WCPP. Initial monitoring for methylene 
chloride is critical for establishing a baseline of exposure for 
potentially exposed persons; similarly, periodic exposure monitoring 
assures continued

[[Page 28301]]

compliance over time so that potentially exposed persons are not 
exposed to levels that would result in an unreasonable risk of injury 
to health. Exposure monitoring could be suspended if certain conditions 
described in this Unit are met. Also, in some cases, a change in 
workplace conditions with the potential to impact exposure levels would 
warrant additional monitoring, which is also described.
    EPA proposes to require that owners or operators determine each 
potentially exposed person's exposure by taking a personal breathing 
zone air sample of each potentially exposed person's exposure, or by 
taking personal breathing zone air samples that are representative of 
each potentially exposed person's exposure. Owners or operators would 
be permitted to consider personal breathing zone air samples to be 
representative of each potentially exposed person's exposure when one 
or more samples are taken for at least one potentially exposed person 
in each job classification in a work area during every work shift, and 
the person sampled is expected to have the highest methylene chloride 
exposure; or when one or more samples are taken which indicate the 
highest likely 15-minute exposures during such operations for at least 
one potentially exposed person in each job classification in the work 
area during every work shift, and the person sampled is expected to 
have the highest methylene chloride exposure. Personal breathing zone 
air samples taken during one work shift may be used to represent 
potentially exposed person exposures on other work shifts where the 
owner or operator can document that the tasks performed and conditions 
in the workplace are similar across shifts. These requirements align 
with the approach taken for characterization of employee exposure in 
the 1997 OSHA standard for methylene chloride (see 29 CFR 
1910.1052(d)(1)(i) and (ii)). EPA also proposes to require that the 
owner or operator ensure, for initial and periodic monitoring, that 
their methods and metering results used in performance of the exposure 
monitoring are accurate to a confidence level of 95% and are within 
(plus or minus) 25% of airborne concentrations of methylene chloride 
above the 8-hour TWA ECEL or the 15-minute TWA EPA STEL, or within 
(plus or minus) 35% for airborne concentrations of methylene chloride 
at or above the ECEL action level but at or below the 8-hour TWA ECEL. 
These requirements, including the 35%, would align with the approach 
taken in the 1997 OSHA standard for methylene chloride (see 29 CFR 
1910.1052(d)(1)(iii)). EPA acknowledges that new monitoring methods or 
technologies may have been developed since 1997 that would allow for 
greater accuracy, and thus a smaller range for monitoring results, and 
EPA requests comment on the exposure monitoring accuracy requirements 
outlined in this Unit. Therefore, while the EPA requirements utilize 
the values of the ECEL, ECEL action level, and EPA STEL, the approach 
should be familiar to the regulated community. To ensure compliance for 
monitoring activities, EPA proposes recordkeeping requirements outlined 
in this Unit. EPA acknowledges that the 25% buffer for the 8-hour and 
15-minute TWA potentially could allow some exposures above the exposure 
limits proposed here. EPA requests comment on these buffers' effects 
and any alternatives to account for measurement variance or 
uncertainty.
ii. Initial Exposure Monitoring
    Under the proposed regulation, each owner or operator of a facility 
engaged in one or more of the conditions of use listed earlier in Unit 
IV.A.1.a. would be required to perform initial exposure monitoring 180 
days after publication of the final rule to determine the extent of 
exposure of potentially exposed persons to methylene chloride. Initial 
monitoring would notify owners and operators of the magnitude of 
possible exposures to potentially exposed persons with respect to their 
work conditions and environments. Based on the magnitude of possible 
exposures in the initial exposure monitoring, the owner or operator may 
need to increase or decrease the frequency of future periodic 
monitoring, adopt new exposure controls (such as engineering controls, 
administrative controls, and/or a respiratory protection program), or 
to continue or discontinue certain compliance activities such as 
periodic monitoring. In addition, the monitoring sample would be 
required to be taken when and where the operating conditions are best 
representative of each potentially exposed person's full-shift 
exposures. If the owner or operator chooses to use a sample that is 
representative of potentially exposed persons' full shift exposures 
(rather than monitor every individual), such sampling should include 
persons closest to the source of methylene chloride, so that the 
monitoring results would be representative of the most highly exposed 
persons in the workplace. Additionally, analogous to the OSHA standard, 
EPA expects that owners and operators would conduct initial exposure 
monitoring representative of all tasks a potentially exposed person 
would be expected to do. EPA understands that certain tasks may occur 
less frequently or may reflect upset conditions (for example, due to 
malfunction). EPA is soliciting comments regarding how owners and 
operators could conduct initial exposure monitoring to ensure that it 
is representative of all tasks likely to be conducted by potentially 
exposed persons.
    EPA also recognizes that the values for the ECEL action level and 
EPA STEL may mean that some owners or operators currently in compliance 
with the OSHA standard would have to re-establish a monitoring 
baseline. Aligning with the existing OSHA standard (29 CFR 
1910.1052(d)(2)) to the extent possible, EPA is proposing that an owner 
or operator may temporarily forgo initial exposure monitoring if:
    (i) An owner or operator could provide EPA with objective data 
generated during the last 5 years demonstrating that methylene chloride 
cannot be released in the workplace in airborne concentrations at or 
above the ECEL action level (1-ppm 8-hour TWA) and above the EPA STEL 
(16 ppm 15-minute TWA) and that the data represent the highest 
methylene chloride exposures likely to occur under reasonably 
foreseeable conditions of manufacturing, processing, use, or disposal, 
as applicable, including handling of methylene chloride during those 
activities. The oldest objective data used to demonstrate that 
exposures are below the ECEL action level and EPA STEL will indicate 
the beginning of the 5-year cycles of recurring initial exposure 
monitoring as described in this Unit;
    (ii) Where potentially exposed persons are exposed to methylene 
chloride for fewer than 30 days per year and the owner or operator has 
measurements by direct-metering devices that give immediate results and 
provide sufficient information regarding potentially exposed persons' 
exposures to determine and implement the control measures that are 
necessary to reduce exposures to below the ECEL action level and EPA 
STEL.
    As described in more detail later in this Unit, unlike the OSHA 
standards in 29 CFR 1910.1052(d)(2) to (d)(3), the owner or operator 
must conduct an initial monitoring at least once every 5 years since 
its last monitoring. This new initial monitoring would have to be 
representative of all the potentially exposed persons in the workplace 
and the tasks that they are expected to do. Additionally, if a facility 
were to

[[Page 28302]]

commence one or more conditions of use listed in Unit IV.A.1.a. after 
the effective date of the rule, the owner or operator would be required 
to perform initial exposure monitoring within 180 days and would be 
required to, at a minimum, conduct initial exposure monitoring every 5 
years thereafter if methylene chloride is present in the facility. EPA 
is soliciting comments regarding the proposed requirement for recurring 
5-year initial exposure monitoring.
iii. Periodic Exposure Monitoring
    EPA's proposal is aligned with elements of the existing OSHA 
standard (29 CFR 1910.1052(d)(3)) to the extent possible. Based on the 
results from the initial exposure monitoring, EPA is proposing the 
following periodic monitoring for owners or operators. These proposed 
requirements are also outlined in Table 1.
     If all samples taken during the initial exposure 
monitoring reveal: a concentration below the ECEL action level (1 ppm 
8-hour TWA) and at or below the EPA STEL (16 ppm 15-minute TWA), the 
ECEL and EPA STEL periodic monitoring would not be required, except 
when additional exposure monitoring (Unit IV.A.1.c.v.) measurements 
require it.
     If the initial exposure monitoring concentration is: below 
the ECEL action level (1 ppm 8-hour TWA) and above the EPA STEL (16 ppm 
15-minute TWA), the ECEL periodic monitoring would not be required 
except when additional monitoring (Unit IV.A.1.c.v.) measurements 
require it, but EPA STEL periodic monitoring would be required every 3 
months.
     If the initial exposure monitoring concentration is: at or 
above the ECEL action level (1 ppm 8-hour TWA) and at or below the ECEL 
(2 ppm 8-hour TWA), and at or below the EPA STEL (16 ppm 15-minute 
TWA), the ECEL would be required to be monitored every 6 months.
     If the initial exposure monitoring concentration is: at or 
above the ECEL action level (1 ppm 8-hour TWA) and at or below the ECEL 
(2 ppm 8-hour TWA), and above the EPA STEL, the ECEL would be required 
to be monitored every 6 months and EPA STEL would be required to be 
monitored every 3 months.
     If the initial exposure monitoring concentration is: above 
the ECEL (2 ppm 8-hour TWA) and below, at, or above the EPA STEL (16 
ppm 15-minute TWA), the ECEL and EPA STEL would be required to be 
monitored every 3 months.
     The owner or operator would be permitted to alter the 
periodic exposure monitoring frequency from every 3 months to every 6 
months if two consecutive monitoring events taken at least 7 days apart 
indicate that the potential exposure has decreased to or below the 
ECEL, but at or above the ECEL action level.
     The owner or operator would be permitted to transition 
from the periodic exposure monitoring frequency of every 6 months to an 
initial exposure monitoring frequency of once every 5 years if two 
consecutive monitoring events taken at least 7 days apart indicate that 
the potential exposure has decreased below the ECEL action level and at 
or below the EPA STEL. The second consecutive monitoring event would 
delineate the new date from which the next 5-year initial exposure 
monitoring must occur.
    In addition to the periodic monitoring standards described earlier, 
EPA is proposing two additional provisions:
     Based on its monitoring results, if the owner or operator 
would be required to monitor either the ECEL or EPA STEL in a 3-month 
interval but does not engage in any of the conditions of use listed in 
Unit IV.A.1.a. for which the WCPP is proposed over the entirety of 
those 3 months, the owner or operator would be permitted to forgo the 
upcoming periodic monitoring event. However, documentation of cessation 
of use of methylene chloride would be required, and initial monitoring 
would be required when the owner or operator resumes or starts any of 
the conditions of use listed in Unit IV.A.1.a. for which the WCPP is 
proposed.
     Based on its monitoring results, if the owner or operator 
would be required to monitor the ECEL in a 6-month interval but does 
not engage in any of the conditions of use listed in Unit IV.A.1.a. for 
which the WCPP is proposed over the entirety of those 6 months, the 
owner or operator would be permitted to forgo the upcoming periodic 
monitoring event. However, documentation of cessation of use of 
methylene chloride would be required, and initial monitoring would be 
required when the owner or operator resumes or starts any of the 
conditions of use listed in Unit IV.A.1.a. for which the WCPP is 
proposed.
     Initial monitoring would be required to occur at least 
once every 5 years if methylene chloride is present. EPA requests 
comment on the timeframes for periodic monitoring outlined in this 
Unit, particularly whether more frequent monitoring may be possible or 
recommended.

   Table 1--Periodic Monitoring Requirements Based on Initial Exposure
                           Monitoring Results
------------------------------------------------------------------------
      Air concentration condition        Periodic monitoring requirement
------------------------------------------------------------------------
If the initial exposure monitoring       ECEL and EPA STEL periodic
 concentration is below the ECEL action   monitoring not required.
 level and at or below the EPA STEL.
If the initial exposure monitoring       ECEL monitoring not required
 concentration is below the ECEL action   and EPA STEL monitoring
 level and above the EPA STEL.            required every 3 months.
If the initial exposure monitoring       ECEL monitoring every 6 months.
 concentration is at or above the ECEL
 action level and at or below the ECEL;
 and at or below the EPA STEL.
If the initial exposure monitoring       ECEL monitoring every 6 months
 concentration is at or above the ECEL    and EPA STEL monitoring every
 action level and at or below the ECEL;   3 months.
 and above the EPA STEL.
If the initial exposure monitoring       ECEL monitoring every 3 months
 concentration is above the ECEL and      and EPA STEL monitoring every
 below, at, or above the EPA STEL.        3 months.
Two consecutive monitoring events have   Reduce periodic monitoring
 taken place 7 days apart that indicate   frequency from every 3 months
 that potential exposure has decreased    to every 6 months.
 from above the ECEL to at or below the
 ECEL, but at or above the ECEL action
 level.
Two consecutive monitoring events have   Transition from periodic
 taken place 7 days apart that indicate   monitoring frequency of every
 that potential exposure has decreased    6 months to initial monitoring
 to below the ECEL action level and at    once every 5 years. The second
 or below the EPA STEL.                   consecutive monitoring event
                                          will delineate the new date
                                          from which the next 5-year
                                          initial exposure monitoring
                                          must occur.

[[Page 28303]]

 
If the owner or operator engages in any  The owner or operator may forgo
 of the conditions of use for which       the upcoming periodic
 WCPP is proposed and is required to      monitoring event. However,
 monitor either the ECEL or EPA STEL in   documentation of cessation of
 a 3-month interval, but does not         manufacture, processing, use,
 engage in any of those conditions of     or disposal of methylene
 use for the entirety of the 3-month      chloride must be maintained,
 interval.                                and initial monitoring would
                                          be required when the owner or
                                          operator resumes or starts any
                                          of the conditions of use for
                                          which the WCPP is proposed.
Owner or operator engages in any of the  The owner or operator may forgo
 conditions of use for which WCPP is      the upcoming periodic
 proposed and is required to monitor      monitoring event. However,
 the ECEL in a 6-month interval, but      documentation of cessation of
 does not engage in any of those          manufacture, processing, use,
 conditions of use for the entirety of    or disposal of methylene
 the 6-month interval.                    chloride must be maintained,
                                          and initial monitoring would
                                          be required when the owner or
                                          operator resumes or starts any
                                          of the conditions of use for
                                          which the WCPP is proposed.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
  discussed in Unit IV.A.1.c.v.

iv. Minimum Frequency of Exposure Monitoring
    EPA is proposing to require that an initial monitoring event be 
conducted at a minimum frequency of every 5 years by owners or 
operators using methylene chloride for any condition of use subject to 
the WCPP. This in contrast to OSHA's standards in 1910.1052(d)(2) to 
(d)(3) whereby employers would otherwise be permitted to discontinue 
monitoring indefinitely based on monitoring results. Moreover, EPA is 
proposing that monitoring requirements could only be made less frequent 
based on the results of the initial exposure monitoring or the periodic 
exposure monitoring outlined under Unit IV.A.1.c.iii.
    OSHA's standards in 1910.1052(d)(2)(i) through (iii) allow for a 
discontinuation of initial monitoring which subsequently precludes the 
need for periodic monitoring unless additional monitoring is required 
under certain conditions. Given the steep dose response for methylene 
chloride that may lead up to and include fatalities as a result of 
inhalation exposure, EPA is instead proposing to require that a minimum 
initial monitoring frequency be established at 5-year intervals. EPA is 
requesting public comments on the proposed conditions for periodic 
monitoring for methylene chloride as part of implementation of the WCPP 
that differ from OSHA's existing monitoring requirements under 29 CFR 
1910.1052.
v. Additional Exposure Monitoring
    In addition to initial and periodic monitoring, there are some 
additional circumstances that would require a new initial exposure 
monitoring. EPA is proposing that the owner or operator complying with 
the WCPP would carry out this additional exposure monitoring (analogous 
to those requirements outlined in 29 CFR 1910.1052(d)(4)) after any 
change that may reasonably be expected to introduce additional sources 
of exposure, or result in a change in exposure levels, to methylene 
chloride. Examples include changes in the production, production 
volume, use rate, process, control equipment, or work practices that 
may reasonably be anticipated to cause additional sources of exposure 
or result in increased exposure levels to methylene chloride; and 
start-up, shutdown, or malfunction of the facility or facility 
equipment that may reasonably be anticipated to cause additional 
sources of exposure or result in increased exposure levels to methylene 
chloride. This additional exposure monitoring event may result in 
increased frequency of periodic monitoring. The required additional 
exposure monitoring should not delay implementation of any necessary 
cleanup or other remedial action to reduce the exposures to potentially 
exposed persons.
d. Exposure Control Plan (ECP)
    EPA recommends and encourages the use of pollution prevention as a 
means of controlling exposures whenever practicable. Pollution 
prevention, also known as source reduction, is any practice that 
reduces, eliminates, or prevents pollution at its source (e.g., 
elimination and substitution, as described in the hierarchy of 
controls). While the WCPP is intended to be non-prescriptive to allow 
more flexibility to regulated entities than requiring specific 
prescriptive controls, EPA is proposing to require the use of 
elimination and substitution, followed by the use of engineering 
controls, administrative controls, and work practices prior to 
requiring the use of respirators as a means of controlling inhalation 
exposures below EPA's ECEL or STEL, in accordance with the hierarchy of 
controls. If an owner or operator chooses to replace methylene chloride 
with a substitute, EPA recommends that they carefully review the 
available hazard and exposure information on the potential substitutes 
to avoid a substitute chemical that might later be found to present 
unreasonable risks or be subject to regulation (sometimes referred to 
as a ``regrettable substitution''). EPA expects that, for conditions of 
use for which EPA is proposing a WCPP, compliance at most workplaces 
would be part of an established industrial hygiene program that aligns 
with the hierarchy of controls. Workplaces that cannot, in accordance 
with that hierarchy, eliminate the source of methylene chloride 
emissions or replace methylene chloride with a substitute would be 
required to use feasible engineering controls, and subsequently 
feasible administrative controls, to implement process changes to 
reduce exposures following the hierarchy of controls (Ref. 9). EPA also 
expects those owners or operators already implementing the OSHA PEL of 
25 ppm as an 8-hour TWA would revise their monitoring program to follow 
EPA's ECEL requirements with EPA's lower ECEL of 2 ppm as an 8-hour TWA 
and EPA's STEL of 16 ppm as a 15-minute TWA.
    Analogous to the OSHA Standard (29 CFR 1910.1052(e)), EPA is 
proposing to require that the owner or operator demarcate any area 
where airborne concentrations of methylene chloride are reasonably 
expected to exceed the ECEL or the EPA STEL. This regulated area would 
be demarcated using administrative controls, e.g., highly visible 
signifiers, in multiple languages as appropriate, placed in conspicuous 
areas, and documented through training and recordkeeping. The owner or 
operator would be required to restrict access to the regulated area 
from any potentially exposed person that lacks proper training or is 
otherwise unauthorized to enter.
    EPA proposes to require regulated entities use the hierarchy of 
controls to the extent feasible and supplement

[[Page 28304]]

further protections using PPE, including respirators for potentially 
exposed persons at risk of inhalation exposure above the ECEL or EPA 
STEL. If efforts of elimination, substitution, engineering controls, 
and administrative controls are not sufficient to reduce exposures to 
or below the ECEL or EPA STEL for all potentially exposed persons in 
the workplace, EPA proposes to require the owner or operator to use 
feasible controls (including elimination, substitution, engineering 
controls, or administrative controls and work practices) to reduce 
methylene chloride concentrations in the workplace to the lowest levels 
achievable and, analogous to the requirements under 29 CFR 
1910.1052(e)(3), supplement these controls with respiratory protection 
and PPE as needed to achieve the ECEL before potentially exposed 
persons enter a regulated area. In such cases, EPA would require that 
the owner or operator provide potentially exposed persons reasonably 
likely to be exposed to methylene chloride by inhalation to 
concentrations above the ECEL or EPA STEL with respirators affording 
sufficient protection against inhalation risk and appropriate training 
on the proper use of such respirators, to ensure that their exposures 
do not exceed the ECEL or EPA STEL, as described in this Unit.
    EPA also proposes to require that the owner or operator document 
their efforts to use elimination, substitution, engineering controls, 
and administrative controls to reduce exposure to or below the ECEL or 
EPA STEL in an exposure control plan. In addition, analogous to the 
requirements under 29 CFR 1910.1052(f)(2), an owner or operator would 
be prohibited from rotating work schedules to comply with the ECEL 8-
hour TWA.
    EPA proposes to require that the owner or operator include and 
document in the exposure control plan or through any existing 
documentation of the facility's safety and health program developed as 
part of meeting OSHA requirements or other safety and health standards 
the following:
    (i) Identification of available exposure controls and rationale for 
using or not using available exposure controls in the following 
sequence (i.e., elimination and substitution, then engineering controls 
and administrative controls) to reduce exposures in the workplace to 
either at or below the ECEL or to the lowest level achievable, and the 
exposure controls selected based on feasibility, effectiveness, and 
other relevant considerations;
    (ii) If exposure controls were not selected, document the efforts 
identifying why these are not feasible, not effective, or otherwise not 
implemented;
    (iii) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training, or other steps 
taken;
    (iv) Regular inspections, evaluations, and updating of the exposure 
controls to ensure effectiveness and confirmation that all persons are 
using them accordingly;
    (v) Occurrence and duration of any start-up, shutdown, or 
malfunction of exposure controls or of facility equipment that causes 
air concentrations above the ECEL or EPA STEL and subsequent corrective 
actions taken during start-up, shutdown, or malfunctions to mitigate 
exposures to methylene chloride; and
    (vi) Objective data generated during the previous 5 years, when 
used to forgo the initial exposure monitoring, must include: the use of 
methylene chloride being evaluated, the source of objective data, 
measurement methods, measurement results, and measurement analysis of 
the use of methylene chloride, and any other relevant data to the 
operations, processes, or person's exposure.
e. Personal Protective Equipment (PPE)
    Where elimination, substitution, engineering, and administrative 
controls are not feasible or sufficiently protective to reduce the air 
concentration to or below the ECEL, or if inhalation exposure above the 
ECEL is still reasonably likely, EPA proposes to set minimum 
respiratory PPE requirements based on an owner or operator's measured 
air concentration for one or more potentially exposed persons and the 
level of PPE needed to reduce exposure to or below the ECEL. In those 
circumstances, EPA is proposing to require that the owner or operator 
also comply with OSHA's General Requirements for PPE standard at 29 CFR 
1910.132 for application of a PPE program. EPA is also proposing that 
the owner or operator comply with 29 CFR 1910.134 for proper use, 
maintenance, fit-testing, and training of respirators. EPA recognizes 
that there may be limitations in using certain types of PPE or 
respirator protection for various work scenarios such as cost, time 
burdens, ergonomic and dexterity considerations, climate, size, and 
capability.
i. Required Dermal Protection
    EPA is proposing to require provision and use of chemically 
resistant gloves in combination with specific activity training (e.g., 
glove selection (type, material), expected duration of glove 
effectiveness, actions to take when glove integrity is compromised, 
storage requirements, procedure for glove removal and disposal, 
chemical hazards) for tasks where dermal exposure can be expected to 
occur. Additionally, EPA is proposing to require owners and operators 
to continue to comply with relevant sections of the methylene chloride 
OSHA standard to minimize and protect potentially exposed persons from 
dermal exposure, including 29 CFR 1910.1052(h) and (i). Additional 
information related to choosing appropriate gloves can be found in the 
NIOSH Hazard Alert (Ref. 35) and in appendix F of the 2020 Risk 
Evaluation for Methylene Chloride (Ref. 1). EPA requests comment on the 
degree to which additional guidance related to use of gloves might be 
necessary. Additionally, EPA requests comment on whether EPA should 
specifically incorporate dermal protection into the exposure control 
plan and require consideration of the hierarchy of controls for dermal 
exposures.
ii. Required Respiratory Protection
    EPA is proposing the following requirements for respiratory 
protection, based on the exposure monitoring concentrations measured as 
an 8-hour TWA that exceeds the ECEL (2 ppm) or 15-minute TWA that 
exceeds the EPA STEL (16ppm); see also the following table (Table 2). 
These requirements would apply after all other feasible controls are 
exhausted or proven ineffective to control inhalation exposure 
(including elimination, substitution, engineering controls, and 
administrative controls in accordance with the hierarchy of controls). 
EPA is proposing to establish minimum respiratory protection 
requirements, such that any respirator affording the same or a higher 
degree of protection than the following proposed requirements may be 
used. While this Unit includes respirator selection requirements for 
respirators of Assigned Protection Factor (APF) of 1,000 or greater, 
EPA does not anticipate that respirators beyond APF 25 will be widely 
or regularly used to address unreasonable risk, particularly when other 
controls are put in place. EPA anticipates that owners or operators 
would attempt to minimize respirator costs by reducing inhalation 
exposures levels so that, if a respirator is needed, a supplied-air 
respirator could be used in lieu of a self-contained breathing 
apparatus. Under this proposed regulatory option, as with existing OSHA 
regulations, air-purifying respirators (in contrast to air-supplied

[[Page 28305]]

respirators) would not be permitted as a means of mitigating methylene 
chloride exposure, as they do not provide adequate respiratory 
protection against this chemical (Ref. 36). Additionally, EPA 
acknowledges in Unit V.A.1. that there may be respirator limitations 
dependent upon the nature of the activity in which methylene chloride 
is used (e.g., a decreased range of motion or access to a small space 
could hinder PPE use).
     If the measured exposure concentration is at or below the 
ECEL (2 ppm 8-hour TWA) and EPA STEL (16 ppm 15-minute TWA): no 
respiratory protection would be required.
     If the measured exposure concentration is above 2 ppm and 
less than or equal to 50 ppm (25 times the ECEL): the respirator 
protection required would be any NIOSH-certified supplied-air 
respirator (SAR) or airline respirator in a continuous-flow mode 
equipped with a loose-fitting facepiece or helmet/hood (APF 25).
     If the measured exposure concentration is above 50 ppm and 
less than or equal to 100 ppm (50 times the ECEL): the respirator 
protection required would be: (i) Any NIOSH-certified Supplied-Air 
Respirator (SAR) or airline respirator in a demand mode equipped with a 
full facepiece (APF 50); or (ii) Any NIOSH-certified Self-Contained 
Breathing Apparatus (SCBA) in demand-mode equipped with a full 
facepiece or helmet/hood (APF 50).
     If the measured exposure concentration is unknown or at 
any value above 100 ppm and up to 2,000 ppm (1,000 times the ECEL): the 
respirator protection required would be: (i) Any NIOSH-certified 
Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-
flow mode equipped with a full facepiece or certified helmet/hood (APF 
1,000); or (ii) Any NIOSH-certified Supplied-Air Respirator (SAR) or 
Airline Respirator in pressure-demand or other positive-pressure mode 
equipped with a full facepiece (APF 1,000); or (iii) Any NIOSH-
certified Self-Contained Breathing Apparatus (SCBA) in a pressure-
demand or other positive-pressure mode equipped with a full facepiece 
or certified helmet/hood (APF 1,000+).

       Table 2--Respiratory Protection Conditions and Requirements
------------------------------------------------------------------------
                                         Minimum required respirator
      Concentration condition                    protection
------------------------------------------------------------------------
At or below the ECEL and EPA STEL.  No respirator required.
Above ECEL (2 ppm) and less than    Any NIOSH-certified supplied-air
 or equal to 50 ppm (25 times the    respirator (SAR) or airline
 ECEL).                              respirator in a continuous-flow
                                     mode equipped with a loose-fitting
                                     facepiece or helmet/hood (APF 25).
Above 50 ppm and less than or       Either (i) any NIOSH-certified
 equal to 100 ppm (50 times the      Supplied-Air Respirator (SAR) or
 ECEL).                              airline respirator in a demand mode
                                     equipped with a full facepiece (APF
                                     50); or (ii) any NIOSH-certified
                                     Self-Contained Breathing Apparatus
                                     (SCBA) in demand-mode equipped with
                                     a full facepiece or helmet/hood
                                     (APF 50).
Unknown concentration or at any     One of (i) any NIOSH-certified
 value above 100 ppm and up to       Supplied-Air Respirator (SAR) or
 2,000 ppm (1,000 times the ECEL).   Airline Respirator in a continuous-
                                     flow mode equipped with a full
                                     facepiece or certified helmet/hood
                                     (APF 1,000); or (ii) any NIOSH-
                                     certified Supplied-Air Respirator
                                     (SAR) or Airline Respirator in
                                     pressure-demand or other positive-
                                     pressure mode equipped with a full
                                     facepiece (APF 1,000); or (iii) any
                                     NIOSH-certified Self-Contained
                                     Breathing Apparatus (SCBA) in a
                                     pressure-demand or other positive-
                                     pressure mode equipped with a full
                                     facepiece or certified helmet/hood
                                     (APF 10,000).
------------------------------------------------------------------------

f. Additional Proposed Requirements
i. Workplace Participation
    EPA encourages owners and operators to consult with potentially 
exposed persons on the development and implementation of exposure 
control plans and PPE/respirator programs. EPA is proposing to require 
owners and operators to provide potentially exposed persons regular 
access to the exposure control plans, exposure monitoring records, PPE 
program implementation, and respirator program implementation (such as 
fit-testing and other requirements) described in 29 CFR 1910.134(l). To 
ensure compliance in workplace participation, EPA is proposing that the 
owner or operator document the notice to and ability of any potentially 
exposed person that may reasonably be affected by methylene chloride 
inhalation exposure to readily access the exposure control plans, 
facility exposure monitoring records, PPE program implementation, or 
any other information relevant to methylene chloride inhalation 
exposure in the workplace.
ii. Notification of Monitoring Results
    EPA proposes that when a potentially exposed person's exposure to 
methylene chloride exceeds the ECEL action level within a regulated 
area, the owner or operator would be required to inform each 
potentially exposed person of the quantity, location, manner of use, 
release, and storage of methylene chloride and the specific operations 
in the workplace that could result in exposure to methylene chloride, 
particularly noting where exposures may be above the ECEL or EPA STEL, 
analogous to those requirements outlined in 29 CFR 1910.1052(l). EPA 
proposes that the owner or operator must, within 15 working days after 
receipt of the results of any exposure monitoring, notify each 
potentially exposed person whose exposure is represented by that 
monitoring in writing, either individually to each potentially exposed 
person or by posting the information in an appropriate and accessible 
location, such as public spaces or common areas, for potentially 
exposed persons outside of the regulated area (as described in Unit 
IV.A.1.d.). The notice would be required to identify the ECEL, ECEL 
action level, and EPA STEL and what they mean in plain language, the 
exposure monitoring results, and any corresponding respiratory 
protection required. The notice would also be required to include a 
description of the actions taken by the owner or operator to reduce 
inhalation exposures to or below the ECEL, or refer to a document 
available to the potentially exposed persons which states the actions 
to be taken to reduce exposures, and to be posted in multiple languages 
if necessary (e.g., notice must be in a language that the potentially 
exposed person understands, including a non-English language version 
representing the language of the largest group of workers who cannot 
readily comprehend or read English). While 15 working days is 
consistent with requirements under the OSHA methylene chloride 
standard, EPA notes that it may be preferable to require more expedient 
notification of monitoring results, and that precedent exists in some 
circumstances for faster

[[Page 28306]]

notification timeframes (e.g., OSHA requirements for the construction 
sector require a 5-day timeframe). EPA therefore requests comment on 
the 15-day timeframe for notification of potentially exposed persons of 
monitoring results and the possibility for a shorter timeframe, such as 
5 days.
iii. Recordkeeping
    For each monitoring event of methylene chloride, OSHA requires 
under 29 CFR 1910.1052(m) that the employer record information 
including, but not limited to, dates; operations involving exposure; 
sampling and analytical methods; the number of samples; durations, and 
results of each sample taken; the type of respirator and PPE worn (if 
any); the exposed employees' names, work shifts, and job 
classifications; and exposure of all the employees represented by 
monitoring, indicating which potentially exposed persons were actually 
monitored. EPA is requiring that this information is kept by the owner 
or operator of record for potentially exposed persons. In addition to 
the requirements outlined in 29 CFR 1910.1052(m)(2), EPA is proposing 
to require documentation of the following whenever monitoring for the 
WCPP is required under TSCA section 6(a):
    (i) All measurements that may be necessary to determine the 
conditions (e.g., work site temperatures, humidity, ventilation rates, 
monitoring equipment type and calibration dates) that may affect the 
monitoring results;
    (ii) All other potentially exposed persons whose exposure 
monitoring was not measured but whose exposure is intended to be 
represented by the area or representative sampling monitoring;
    (iii) Use of established analytical methods such as those outlined 
in appendix A of the ECEL memo (Ref. 11) with a limit of detection 
below the ECEL action level and accuracy of monitoring within 25% for 
the ECEL and 35% for the EPA STEL, as discussed in Unit IV.A.1.c.ii., 
so that the owner or operator may identify when the implementation of 
additional exposure controls is necessary, determine the monitoring 
frequency according to the requirements described in this Unit, and 
properly identify and provide persons exposed to methylene chloride 
with the required respiratory equipment and PPE proposed in this Unit;
    (iv) Compliance with the Good Laboratory Practice Standards at 40 
CFR part 792;
    (v) Information regarding air monitoring equipment, including: 
type, maintenance, calibrations, performance tests, limits of 
detection, and any malfunctions.
    For owners and operators to demonstrate compliance with the WCPP 
provisions, EPA is proposing that owners and operators must retain 
compliance records for 5 years, unless a longer retention time is 
required under 29 CFR 1910.1020, or other applicable regulations. EPA 
is requiring the owner or operator to retain records of:
     Exposure control plan;
     Regulated areas and authorized personnel;
     Facility exposure monitoring records;
     Notifications of exposure monitoring results;
     PPE and respiratory protection used and program 
implementation; and
     Information and training required under 29 CFR 1910.1052 
section (l) and appendix A, provided by the owner or operator to each 
potentially exposed person prior to or at the time of initial 
assignment to a job involving potential exposure to methylene chloride.
    All records required to be maintained by this Unit could be kept in 
the most administratively convenient form (electronic or paper). The 
owner or operator would be required to document training or re-training 
(analogous to 29 CFR 1910.1052(l)(5)) of any potentially exposed person 
as necessary to ensure that, in the event of monitoring results that 
indicate exposure or possible exposures above the ECEL action level or 
the EPA STEL, the potentially exposed person has demonstrated 
understanding of how to safely use and handle methylene chloride and 
how to appropriately use required PPE. EPA expects that the content of 
such training will not exceed what is already required by 29 CFR 
1910.1052 section (l) and appendix A. In addition, the owner or 
operator would be required to update the training and requisite 
documentation when there is reasonable expectation that exposure may 
exceed the ECEL action level due to change in tasks or procedures.
g. Compliance Timeframes
    With regard to the compliance timeframe for those occupational 
conditions of use which are subject to the WCPP, EPA is proposing to 
require that owners and operators establish initial exposure monitoring 
according to the process outlined in this Unit by [DATE 180 DAYS AFTER 
DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]. EPA is 
proposing to require each owner or operator ensure that the airborne 
concentration of methylene chloride does not exceed the ECEL or EPA 
STEL for all potentially exposed persons by [DATE 270 DAYS AFTER DATE 
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], and if 
applicable, each owner or operator must provide respiratory protection 
sufficient to reduce inhalation exposures to below the ECEL or EPA STEL 
to all potentially exposed persons in the regulated area within 3 
months after receipt of the results of any exposure monitoring or 
within 9 months after the date of publication of the final rule in the 
Federal Register (for any new facilities, or a facility commencing one 
or more conditions of use listed in Unit IV.A.1.a. after the effective 
date of the final rule, the timeframe for the requirement for initial 
exposure monitoring is described earlier in Unit IV.A.1.c.ii.; 
following that, the requirements and timeframes in this Unit would 
apply). EPA is also proposing to require owners and operators demarcate 
a regulated area within 3 months after receipt of any exposure 
monitoring that indicates exposures exceeding the ECEL or EPA STEL. 
Owners and operators should proceed accordingly to implement an 
exposure control plan by [DATE 360 DAYS AFTER DATE OF PUBLICATION OF 
FINAL RULE IN THE FEDERAL REGISTER]. EPA requests comment relative to 
the ability of owners or operators to conduct initial monitoring by 
[DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL 
REGISTER], and anticipated timelines for any procedural adjustments 
needed to comply with the requirements outlined in this Unit. EPA may 
finalize shorter or longer compliance timeframes based on public 
comment.
2. Prohibition of Certain Industrial and Commercial Uses
    Except for those uses which will continue under the WCPP, EPA is 
proposing to prohibit industrial and commercial use of methylene 
chloride, including use of methylene chloride in: solvent for batch 
vapor degreasing; solvent for in-line vapor degreasing; solvent for 
cold cleaning; solvent for aerosol spray degreaser/cleaner; adhesives, 
sealants, and caulks; paints and coatings; paint and coating removers 
(including furniture refinishers); adhesive and caulk removers; metal 
aerosol degreasers; metal non-aerosol degreasers; finishing products 
for fabric, textiles and leather; automotive care products (functional 
fluids for air conditioners); automotive care products (interior car 
care); automotive care products (degreasers); apparel and footwear care 
products; spot removers for apparel and textiles; liquid lubricants and 
greases; spray lubricants and greases; aerosol

[[Page 28307]]

degreasers and cleaners; non-aerosol degreasers and cleaners; cold pipe 
insulations; solvent that becomes part of a formulation or mixture; 
processing aid; propellant and blowing agent; electrical equipment, 
appliance, and component manufacturing; plastic and rubber products 
manufacturing; cellulose triacetate film production; anti-spatter 
welding aerosol; oil and gas drilling, extraction, and support 
activities; toys, playground and sporting equipment; carbon remover, 
wood floor cleaner, and brush cleaner; and lithographic printing plate 
cleaner. This does not include manufacturing and processing of 
methylene chloride for commercial use or industrial and commercial use 
of methylene chloride as a laboratory chemical, for which EPA is 
proposing to require compliance with a WCPP for the reasons described 
in Unit III.B.3. This rationale is discussed further in Unit V.A.1.
    As Discussed in Unit III.B.1.f., the restrictions in this proposed 
rule do not apply to any substance that is excluded from the definition 
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi). 
However, EPA requests comment on the impacts, if any, the proposed 
prohibition described in this Unit, or other aspects of this proposal, 
may have on the production and availability of any food, food additive, 
drug, cosmetic, device, or other substance excluded from the definition 
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi).
    As discussed in Unit III.B.3., based on consideration of 
alternatives, the broad range of work environments and activities, and 
the severity of the hazards of methylene chloride, EPA determined that 
prohibition is the best way to address the unreasonable risk from 
methylene chloride driven by the conditions of use identified in this 
Unit. EPA requests comment regarding the number of entities that could 
potentially close as well as associated costs with a prohibition of 
methylene chloride for certain industrial and commercial conditions of 
use identified in this Unit. EPA would also like comment on whether it 
should consider a de minimis level of methylene chloride in 
formulations for certain continuing industrial and commercial uses to 
account for impurities (e.g., 0.1% or 0.5%) when finalizing the 
prohibitions described in this Unit, and, if so, what level should be 
considered de minimis.
    EPA is proposing that the prohibition for uses described in this 
section would become effective following prohibitions relevant to these 
uses in stages of the supply chain before the industrial and commercial 
use (e.g., manufacturing and processing). This proposal includes 
restrictions in a staggered schedule for each stage of the supply chain 
and would come into effect in 90 days for manufacturers, 180 days for 
processors, 270 days for distributors to retailers, 360 days for all 
other distributors and retailers, and 450 days for industrial and 
commercial uses after the publication date of the final rule. When 
proposing these compliance dates, EPA considered sustained awareness of 
risks, including acute fatalities, resulting from methylene chloride 
exposure as well as precedent established by the OSHA standards (62 FR 
1494, January 10, 1997). EPA has no information indicating that the 
proposed compliance dates are not practicable for the activities that 
would be prohibited, or that additional time is needed for products 
affected by the proposed restrictions to clear the channels of trade. 
However, EPA requests comment on whether additional time is needed, for 
example, for products affected by proposed restrictions to clear the 
channels of trade. EPA may finalize shorter or longer compliance 
timeframes based on public comment.
    Additionally, EPA recognizes that there may be instances where an 
ongoing use of methylene chloride that has implications for national 
security or critical infrastructure as it relates to other Federal 
agencies (e.g., DOD, NASA) is identified after the methylene chloride 
rule is finalized, but the final rule prohibits that use. For instances 
like that, EPA requests comments on an appropriate, predictable process 
that could expedite reconsideration for uses that Federal agencies or 
their contractors become aware of after the final rule is issued using 
the tools available under TSCA, aligning with the requirements of TSCA 
section 6(g). One example of an approach could be the establishment by 
rulemaking of a Federal agency category of use that would require 
implementation of the WCPP and periodic reporting to EPA on details of 
the use as well as progress in discontinuing the use or finding a 
suitable alternative. To utilize the category of use a Federal agency 
would petition EPA, supported by documentation describing the specific 
use (including documentation of the specific need, service life of any 
relevant equipment, and specific identification of any applicable 
regulatory requirements or certifications, as well as the location and 
quantity of the chemical being used); the implications of cessation of 
this use for national security or critical infrastructure (including 
how the specific use would prevent injuries/fatalities or otherwise 
provide life-supporting functions); exposure control plan; and, for 
Federal agency uses where similar adoption by the commercial sector may 
be likely, concrete steps taken to identify, test, and qualify 
substitutes for the uses (including details on the substitutes tested 
and the specific certifications that would require updating; and 
estimates of the time required to identify, test, and qualify 
substitutes with supporting documentation). EPA requests comment on 
whether these are the appropriate types of information for use in 
evaluating this type of category of use, and whether there are other 
considerations that should apply. EPA would make a decision on the 
petition within 30 days and publish the decision in the Federal 
Register shortly after. Additionally, during the year following the 
petition, EPA would take public comment on the approved petition and no 
later than 180 days after submitting the petition to EPA, the 
requesting agency would submit monitoring data indicating compliance 
with the WCPP at each relevant location as well as documentation of 
efforts to identify or qualify substitutes. In the absence of that 
confirmatory data, the utilization of the generic Federal agency 
category of use would expire within one year of the date of receipt by 
EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking 
for those instances where the Federal agency could not demonstrate 
compliance with the WCPP. This is just one example of a potential 
process. EPA requests comments on a process that could expedite 
reconsideration for uses that Federal agencies or their contractors 
become aware of after the final rule is issued.
3. Prohibition of Manufacturing, Processing, and Distribution of 
Methylene Chloride for Consumer Use
    In the 2020 Risk Evaluation for Methylene Chloride, EPA evaluated 
consumer use of methylene chloride: as a solvent in aerosol spray 
degreasers/cleaners; in adhesives and sealants in single component 
glues and adhesives and sealants in caulks; in paints and coatings in 
brush cleaners and in adhesive/caulk removers; in metal products in 
aerosol and non-aerosol degreasers and cleaners; in automotive care 
products in functional fluids for air conditioners and in degreasers; 
in lubricants and greases in liquid and spray lubricants and greasers 
and in aerosol and non-aerosol degreasers and cleaners; in building and 
construction

[[Page 28308]]

materials in cold pipe insulation; in arts, crafts, and hobby materials 
in crafting glue and cement/concrete; and in other uses such as anti-
spatter welding aerosol and in carbon remover and brush cleaner. All 
consumer uses evaluated in the 2020 Risk Evaluation for Methylene 
Chloride drive unreasonable risk of injury to health. As such, for 
purposes of this risk management rulemaking, ``consumer use'' refers to 
all known, intended, or reasonably foreseen methylene chloride consumer 
uses. EPA is proposing to prohibit the manufacturing, processing, and 
distribution in commerce of methylene chloride for all consumer use. 
(The proposed prohibitions would not extend to the use of methylene 
chloride in consumer paint and coating removers since that use was not 
evaluated in the 2020 Risk Evaluation for Methylene Chloride and 
manufacturing, processing, and distribution for that use are already 
prohibited. (84 FR 11420 (March 27, 2019)).
    As discussed in Unit III.B.3., based on consideration of the 
severity of the hazards of methylene chloride in conjunction with the 
limited options available to adequately address the identified 
unreasonable risk to consumers and bystanders under TSCA section 6(a), 
EPA is proposing to address the unreasonable risk from consumer use by 
prohibiting the manufacturing (including import), processing, and 
distribution in commerce of methylene chloride for consumer use in 
order to remove methylene chloride and products containing methylene 
chloride from the market, thereby effectively eliminating instances of 
consumer use.
    Additionally, EPA is proposing to prohibit retailers from 
distributing in commerce methylene chloride and all methylene chloride-
containing products, in order to prevent products intended for 
industrial and commercial use under the WCPP outlined in Unit IV.A.1. 
from being purchased by consumers. A retailer is any person or business 
entity that distributes or makes available products to consumers, 
including through e-commerce internet sales or distribution. If a 
person or business entity distributes or makes available any product to 
at least one consumer, then it is considered a retailer (40 CFR 
751.103). For a distributor not to be considered a retailer, the 
distributor must distribute or make available products solely to 
commercial or industrial end-users or businesses. Prohibiting 
manufacturers (including importers), processors, and distributors from 
distributing methylene chloride, or any products containing methylene 
chloride, to retailers would prevent retailers from making these 
products available to consumers, which would help address that part of 
the unreasonable risk driven by consumer use of methylene chloride 
(Ref. 37). EPA promulgated a similar prohibition for retailers in the 
2019 final rule addressing unreasonable risk from consumer use of 
methylene chloride in Paint and Coating Removal (84 FR 11420, March 27, 
2019), and has not received negative feedback from retailers regarding 
sales losses. EPA has continued to receive feedback from stakeholders, 
including small businesses, on particular strategies they suggest could 
be used to ensure that distribution only occurs to commercial entities, 
such as requiring a business number (Ref. 6). To that end, EPA would 
like comment on whether distributors that are not retailers should be 
required to use tax IDs or other verification methods prior to selling 
methylene chloride or products containing methylene chloride to ensure 
consumers are not purchasing methylene chloride or industrial or 
commercial products containing methylene chloride.
    Additionally, during litigation on the 2019 final rule petitioners 
argued that EPA's definition of ``retailer'' was so broad as to cover 
all commercial entities, creating supply chain issues for commercial 
users seeking to attain and use the chemical for commercial activities 
(Lab. Council for Latin Am. Advancement v. United States Env't Prot. 
Agency, 12 F.4th 234 (2d Cir. 2021)). EPA has not found this to be the 
case; small businesses that are non-retail distributors exist and even 
participated as small entity representatives consulted as part of the 
SBAR process for this rulemaking. Nonetheless, EPA is soliciting 
comment on whether similar supply chain issues for uses that are 
permitted under the WCPP are anticipated.
    EPA is proposing that the prohibitions of manufacturing, 
processing, and distribution in commerce of methylene chloride for 
consumer use described in this section would occur in 90 days for 
manufacturers, 180 days for processers, 270 days for distributing to 
retailers, and 360 days for all other distributors and retailers after 
the publication date of the final rule in the Federal Register. EPA 
considered irreversible health effects and risks, such as acute 
fatalities, associated with methylene chloride when proposing 
compliance dates. EPA has no information indicating these compliance 
dates are not practicable for the activities that would be prohibited, 
or that additional time is needed for products affected by proposed 
restrictions to clear the channels of trade. However, EPA requests 
comment on whether additional time is needed, for example, for products 
affected by proposed restrictions to clear the channels of trade. EPA 
may finalize shorter or longer compliance timeframes based on public 
comment. EPA would also like comment on whether it should consider a de 
minimis level of methylene chloride in formulations for certain 
continuing industrial and commercial uses to account for impurities 
(e.g., 0.1% or 0.5%) when finalizing these prohibitions, and, if so, 
what level should be considered de minimis.
4. Other Requirements
a. Recordkeeping
    For conditions of use that are not otherwise prohibited under this 
proposed regulation, EPA is also proposing that manufacturers, 
processors, and distributors maintain ordinary business records, such 
as invoices and bills-of-lading, that demonstrate compliance with 
restrictions and other provisions of this proposed regulation; and that 
they maintain such records for a period of 5 years from the date the 
record is generated. EPA notes that this 5-year record retention period 
is an increase from the 3-year requirements for records related to 
consumer paint and coating removal finalized in the 2019 final rule. 
However, the 3-year requirement still applies to records generated 
under that rule. EPA is proposing that this requirement begin at the 
effective date of the rule (60 days following publication of the final 
rule in the Federal Register). Recordkeeping requirements would ensure 
that owners or operators can demonstrate compliance with the proposed 
regulations if necessary. Note that this requirement would expand those 
recordkeeping requirements promulgated in 2019 at 40 CFR 751.109 
affecting manufacturers, processors, and distributors of methylene 
chloride.
b. Downstream Notification
    For conditions of use that are not otherwise prohibited under this 
proposed regulation, EPA is proposing that manufacturers (including 
importers), processors, and distributors, excluding retailers, of 
methylene chloride and methylene chloride-containing products provide 
downstream notification of certain prohibitions through Safety Data 
Sheets

[[Page 28309]]

(SDSs) by adding to sections 1(c) and 15 of the SDS the following 
language:

    After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], this chemical/product cannot be distributed 
in commerce to retailers. After [DATE 360 DAYS AFTER DATE OF 
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], this chemical/
product is and can only be distributed in commerce or processed for 
the following purposes: (1) Processing as a reactant; (2) Processing 
for incorporation into a formulation, mixture, or reaction product; 
(3) Processing for repackaging; (4) Processing for recycling; (5) 
Industrial or commercial use as a laboratory chemical; (6) 
Industrial or commercial use as a bonding agent for acrylic and 
polycarbonate in mission-critical military and space applications, 
including in the production of specialty batteries for such 
applications that is performed by the Department of Defense, the 
Department of Homeland Security, or the National Aeronautics and 
Space Administration or their contractors at locations controlled by 
the agency or the agency's contractor; (7) Industrial or commercial 
use for paint and coating removal from safety-critical, corrosion-
sensitive components of aircraft and spacecraft that are owned or 
operated by the U.S. Department of Defense, the National Aeronautics 
and Space Administration, the U.S. Department of Homeland Security, 
and the Federal Aviation Administration that is performed by the 
agency or agency contractors at locations controlled by the agency 
or the agency's contractor; (8) Industrial or commercial use for 
paint and coating removal from safety-critical, corrosion-sensitive 
components of other aircraft and spacecraft until [10 years after 
date of publication of the final rule in the Federal Register], and 
(9) Disposal.

    The intention of downstream notification is to spread awareness 
throughout the supply chain of the restrictions on methylene chloride 
under TSCA as well as provide information to commercial end users about 
allowable uses of methylene chloride. Note that this requirement would 
amend and add to the downstream notification requirements promulgated 
in 2019 at 40 CFR 751.107 for paint and coating removers for consumer 
use, and additionally redesignate that section as 751.111(a). As they 
become effective, the new amended requirements would supersede those 
notification requirements promulgated in 2019.
    To provide adequate time to update the SDS and ensure that all 
products in the supply chain include the revised SDS, EPA is proposing 
a 150-day period for manufacturers and a 210-day period for processors 
and distributors to implement the proposed SDS changes (following 
publication of the final rule).
    EPA requests comments on the appropriateness of identified 
compliance timeframes for recordkeeping and downstream notification 
requirements described in this Unit.
5. TSCA Section 6(g) Exemptions
    Under TSCA section 6(g)(1), EPA may grant an exemption from a 
requirement of a TSCA section 6(a) rule for a specific condition of use 
of a chemical substance or mixture. TSCA section 6(g)(1)(B) permits 
such an exemption if EPA finds that compliance with the requirement, as 
applied with respect to the specific condition of use, would 
significantly disrupt the national economy, national security, or 
critical infrastructure.
    TSCA section 6(g)(2) requires EPA to analyze the need for the 
exemption, and to make public the analysis and a statement describing 
how the analysis was taken into account when proposing an exemption 
under TSCA section 6(g). To that end, based on discussions and 
information provided by industry stakeholders, EPA has analyzed the 
need for different exemptions and is proposing to grant two of them, 
with conditions as required under TSCA section 6(g)(4) and described in 
Units IV.A.5.a.ii. and IV.A.5.b.ii. This Unit presents the results of 
that analysis.
a. Uses of Methylene Chloride for Paint and Coating Removal Essential 
for Critical Infrastructure
i. Analysis of the Need for TSCA Section 6(g)(1)(B) Exemption for 
Commercial Aviation and Aerospace
    EPA has preliminarily determined that a prohibition on the 
commercial use of methylene chloride for paint and coating removal from 
safety-critical, corrosion-sensitive components of aircraft and 
aerospace vehicles for commercial aviation and aerospace would 
significantly disrupt the national economy and critical infrastructure. 
Aviation has been designated by co-sector agencies DHS and DOT as a key 
subsector in the Transportation Systems Sector, one of 16 designated 
critical infrastructure sectors. There are no technically feasible 
alternatives currently available for methylene chloride used in paint 
and coating removal for safety-critical, corrosion-sensitive components 
of aircraft and aerospace vehicles. Thus, commercial aviation and 
aerospace compliance with the proposed ban on methylene chloride use in 
commercial paint and coating removal would significantly disrupt 
critical infrastructure.
    As explained by a commenter on the 2017 Notice of Proposed 
Rulemaking (NPRM), all aircraft have similar safety-critical, 
corrosion-sensitive components of the type described by DOD (Ref. 38). 
For example, commercial aircraft often contain components, such as 
landing gear, that are made from high-strength alloy steels. According 
to this commenter, the aerospace industry, like DOD, has made 
significant investments in the evaluation of alternative methods and 
materials for removing coatings. The commenter states that the industry 
has had some success, depending upon the substrate, surface treatment, 
and coating system, but investigation continues into both chemical and 
non-chemical means. Non-chemical methods, such as plastic beads, were 
not suitable in all instances due to concerns about damaging the 
substrate. Many alternative chemical strippers were not effective on 
all coatings, which caused corrosion concerns in some cases. According 
to this commenter, benzyl alcohol is a qualified alternative paint 
remover for some paint formulations but cannot be considered a ``drop-
in'' replacement for all applications due to performance concerns.
    The concerns expressed by this commenter about corrosion-sensitive 
components on aircraft and aerospace equipment echo the concerns over 
methylene chloride alternatives expressed by DOD and discussed at 
length in the preamble to EPA's 2017 proposal. For example, both the 
commenter and DOD stated that currently available substitute chemicals 
cannot completely remove certain coatings (Ref. 38). This results in 
improperly applied, incompletely adhering replacement coatings, which 
may result in corrosion of underlying critical parts. For another 
example, according to the commenter and DOD, substitute chemicals are 
also incompatible with some underlying metallic, nonmetallic, and 
composite materials, resulting in material damage to critical 
components, and the potential for an increased risk of catastrophic 
failure of safety critical parts. The commenter on the 2017 NPRM also 
stated that the process for evaluating and then adopting alternatives 
in aviation applications is a multi-year process. According to the 
commenter, the materials required to remove coatings on aircraft parts 
must be developed by a material formulator to meet technical 
performance requirements and must be ``qualified by the Original 
Equipment Manufacturer (OEM), and then shown to not cause harm to the 
aircraft or negatively affect performance to the FAA prior to 
implementation'' (Ref. 38). The commenter stated that this can take 
years, with no guarantee of success, so

[[Page 28310]]

a longer timeframe for aviation and aerospace to make the transition is 
appropriate. The commenter suggested that 10 years would be a realistic 
estimate of the time needed.
    More recently, Boeing provided information to EPA indicating that 
the company has invested considerable resources over many years to 
qualify and implement alternatives to methylene chloride, including a 
combination of acid, alkaline, and hydrogen peroxide-activated benzyl 
alcohol removers and plastic media blast (Ref. 31). Boeing continues to 
evaluate potential alternatives, such as laser ablation, which the 
company believes will, if implemented, eliminate hazardous waste, 
address ergonomic challenges and save significant time over traditional 
paint and coating removal operations. According to Boeing, the company 
has identified several paint and coating removal applications with no 
feasible alternatives to methylene chloride (Ref. 31). These include:
     Large parts or parts with complex geometries that cannot 
undergo media blasting or strip tank immersion either due to size 
constraints or entrapment concerns, and where hand abrasion is 
impractical;
     Situations in which selective coating removal is needed, 
e.g., the preservation of a conversion coating;
     Effective removal of oven-cured paints and coatings;
     Localized removal of coatings on overhaul or rework parts 
to reveal part markings and serial numbers;
     Stripping of parts preceding non-destructive testing, 
where other coating removal methods such as media blasting could hide 
defects; and
     Removal of polyvinyl formal or polyurethane insulating 
enamel from copper magnet wire.
    While there are alternatives available for many applications, the 
public comments on the 2017 NPRM, and the information provided by 
Boeing in 2022 demonstrate there are several aviation and aerospace 
applications for which there are limited alternatives to methylene 
chloride for paint and coating removal, due to concerns about damage to 
the substrate, and these limited alternatives take longer to work. EPA 
has preliminarily determined that lengthening the time that commercial 
aircraft and spacecraft are out of service due to necessary safety 
inspections and repairs will have a considerable adverse impact on air 
travel and other infrastructure elements such as satellite placement. 
Therefore, EPA has preliminarily determined that requiring commercial 
aviation and aerospace sectors to comply at this time with the ban on 
methylene chloride use in paint and coating removal would cause 
significant disruption to critical infrastructure. In addition, EPA has 
preliminarily determined that compliance at this time with the proposed 
ban on the manufacture, processing, and distribution in commerce of 
methylene chloride for commercial paint and coating removal for these 
specific commercial aviation and aerospace uses would also result in a 
significant disruption to critical infrastructure. EPA's proposed 
conditions for this exemption are described in this Unit, including 
proposed requirements to comply with the WCPP.
    EPA acknowledges that in many cases commercial aviation facilities 
may be more sophisticated and industrialized than other commercial 
paint and coating removal operations. However, at the time of proposal, 
data available to EPA demonstrate that the risks from paint and coating 
removal in the aviation sector do not differ significantly from other 
commercial paint and coating removal (Ref. 1). As shown in the 2020 
Risk Evaluation for Methylene Chloride, high-end and central tendency 
estimates for aircraft paint stripping are three orders of magnitude 
below the benchmark for acute inhalation risks and four orders of 
magnitude below the benchmark for chronic non-cancer inhalation risks 
(Ref. 1). Even if use of APF 50 air supplied respirators were assumed, 
the risks that remain for both high-end and central tendency would be 
an order of magnitude below the benchmark for both endpoints (Ref. 1). 
Therefore, while EPA expects that some of these facilities could 
successfully follow the requirements of the WCPP, based on qualitative 
information provided by stakeholders, this expectation is not 
sufficiently supported by monitoring data in the 2020 Risk Evaluation 
for Methylene Chloride. As a result, there is significant uncertainty 
whether the requirements of the WCPP could be implemented successfully 
in this sector for this particular use on a consistent and reliable 
basis, in part due to the diversity of facilities in this sector. EPA 
understands that generally large commercial aviation facilities could 
have industrial hygiene expertise, sophisticated engineering and 
administrative controls, and experience with rigorous safety 
requirements and methods for ensuring continuous strong safety records 
(Ref. 31). However, EPA is concerned about the ability of smaller 
aircraft repair shops to implement the WCPP over the long term, 
particularly for this condition of use. While EPA recognizes that the 
proposed TSCA section 6(g) exemption for commercial aircraft paint and 
coating removal could also cover these smaller aircraft repair shops, 
the exemption is time-limited and ultimately would result in these 
small shops using alternatives to methylene chloride. While Federal 
agencies and contractors should be regulated under the WCPP, the Agency 
is proposing that commercial use of methylene chloride for a similar 
type of paint and coating removal be regulated with a time-limited, 
conditional exemption under TSCA section 6(g), due to notable 
differences in the two sectors. Specifically, exposure information 
assessed by EPA resulted in key differences in risk estimates for paint 
and coating removal by civilian aviation and DOD (see discussion in 
this Unit and Unit V.A.1.). Additionally, as described in Unit V.A.1., 
Federal and Federal contractor facilities are subject to multiple 
levels of oversight as a result of the governmental and public nature 
of their activities, while many civilian aviation facilities are not 
likely to experience the same level of scrutiny. EPA emphasizes that in 
the absence of information, it must still ensure that unreasonable 
risks are addressed. Because EPA has found inadequate information to 
otherwise determine whether the unreasonable risk would be addressed 
when using methylene chloride under a WCPP for commercial use of 
methylene chloride for paint and coating removal from safety-critical, 
corrosion-sensitive components of aircraft and aerospace vehicles for 
commercial aviation and aerospace, EPA has determined that the proposed 
exemption under TSCA section 6(g) allowing for time-limited, 
conditional use of methylene chloride for this critical use is the 
appropriate approach.
    EPA recognizes that in some situations, certain facilities may do 
both Federal contractor and commercial aviation work and may use 
methylene chloride for paint and coating removal from safety-critical, 
corrosion-sensitive components on military, Federal, or commercial 
aviation. EPA requests comment on whether such co-located activities in 
a facility should be subject to the WCPP, rather than the exemption 
under TSCA section 6(g). Additionally, EPA seeks additional information 
and requests comment on whether it is possible to distinguish between 
commercial aviation facilities that would be able to meet the WCPP and 
those that would not, including what criteria should be used for such 
distinctions (e.g., size of facility, volume

[[Page 28311]]

or type of work performed, record of exposure reduction practices). EPA 
also requests comment on the extent to which specific commercial 
aviation and aerospace uses or types of facilities could fully comply 
with the WCPP to address identified unreasonable risk.
ii. Proposed Exemptions for Uses of Methylene Chloride for Paint and 
Coating Removal That Are Essential for Critical Infrastructure
    For the reasons discussed in this Unit, EPA is proposing to provide 
a 10-year exemption for commercial aviation and commercial aerospace 
applications from the proposed prohibition on the use of methylene 
chloride in commercial paint and coating removal. In defining the scope 
of the exemption to limit the exemption to commercial aviation and 
aerospace, EPA looked to the definitions and provisions of the Federal 
Aviation Regulations in title 14 of the CFR. Air carriers and 
commercial operators are certificated under 14 CFR part 119. Repair 
stations are certificated under 14 CFR part 145. To effectively prevent 
significant disruptions to critical infrastructure including commercial 
aviation and aerospace, EPA would make this exemption available to 
three different groups of commercial entities. In each case, the 
exemption would be available only for the use of methylene chloride to 
remove paint and coatings from safety-critical, corrosion-sensitive 
components of aircraft or aerospace vehicles. The first group would 
consist of those facilities that primarily maintain and repair aircraft 
used by air carriers and commercial operators. More specifically, 
maintenance and repair facilities operated by air carriers and 
commercial operators certificated under 14 CFR part 119 would be 
eligible for the exemption, as would be repair stations certificated 
under 14 CFR part 145, if their primary business is performing 
maintenance, preventive maintenance, rebuilding, or alteration of 
aircraft operated by air carriers and commercial operators certificated 
under 14 CFR part 119. The second group would consist of manufacturers 
of aircraft intended for, or capable of being used by, air carriers and 
commercial operators certificated under 14 CFR part 119. The third 
group would consist of any person manufacturing or repairing 
spacecraft, space vehicles, or payloads or similar hardware that is 
intended for, or used in, commercial space transportation operations 
subject to 14 CFR chapter III.
    The conditions for the proposed exemption would be: (1) The use of 
methylene chloride for commercial paint or coating removal by 
certificated air carriers, commercial operators, or repair stations, or 
by manufacturers of aircraft or aerospace vehicles or hardware, would 
be limited to the safety-critical, corrosion-sensitive components on 
aircraft and aerospace vehicles; (2) The use of methylene chloride for 
paint or coating removal would be required to be performed on the 
premises of the certificated air carrier or commercial operator or 
repair station, or of the manufacturer of aircraft or aerospace 
vehicles or hardware; and (3) The certificated air carrier, commercial 
operator, repair station, or manufacturer of aircraft or aerospace 
vehicles and hardware manufacturer would have to comply with the WCPP 
discussed in Unit IV.A.1.
    EPA wishes to make clear that the exemption for the commercial 
aerospace and aviation industry would only be available for the purpose 
of paint and coating removal from components of aircraft and spacecraft 
that are corrosion-sensitive and safety critical components, such as 
landing gear, gear boxes, turbine engine parts, and other aircraft and 
spacecraft and components composed of metallic materials (specifically 
high-strength steel, aluminum, titanium, and magnesium) and composite 
materials. In addition, these components would have to be of the type 
that not only require their paint or coatings to be removed for 
inspection and maintenance but also would be so negatively affected by 
the use of paint and coating removal chemicals or methods other than 
methylene chloride that the safety of the system could be compromised. 
General paint and coating removal on aircraft and spacecraft would not 
be authorized under this exemption. One commenter on the 2017 proposal 
suggested that EPA clarify that only the manufacturer of the component 
may make this determination. In EPA's view, persons availing themselves 
of the exemption would need to have a reasonable basis to conclude that 
the components on which methylene chloride is used are corrosion-
sensitive and safety critical components within the meaning of the 
definition. EPA believes such persons could rely, in part, on 
information supplied by the manufacturer of the component. A 
determination of whether a particular component of an aircraft or 
spacecraft is a safety-critical corrosion-sensitive component would be 
a fact-specific determination that takes into account the substrate and 
character of the component, the effects of methylene chloride paint or 
coating remover on the component, and other relevant factors.
    The entities subject to the proposed exemption would nonetheless 
still be subject to the proposed general recordkeeping requirements 
discussed in Unit IV.A., the WCPP recordkeeping requirements discussed 
in Unit IV.A.1.f.iii., and requirements to maintain records that 
demonstrate compliance with the exemption conditions, including the 
condition that methylene chloride only be used for paint and coating 
removal from corrosion-sensitive and safety critical components of an 
aircraft or spacecraft. Pursuant to TSCA section 6(g)(3), if this 
proposed exemption is finalized, EPA may by rule later extend, modify, 
or eliminate the exemption, on the basis of reasonably available 
information and after adequate public justification, if EPA determines 
the exemption warrants a change. EPA would initiate this rulemaking 
process (e.g., proposed rule, final rule) at the request of any 
regulated entity benefiting from such an exemption, as appropriate. The 
Agency is open to engagement throughout the duration of any TSCA 
section 6(g) exemption, and emphasizes that to ensure continuity in the 
event of an extension or modification request, such a request should 
come at least 2 years prior to the expiration of an exemption.
    EPA requests comments on all aspects of the proposed TSCA section 
6(g) exemption from the proposed prohibition on use of methylene 
chloride in commercial paint and coating removal for paint and coating 
removal essential for critical infrastructure by certificated 
commercial air carriers, commercial operators, or repair stations, or 
by manufacturers of aircraft or aerospace vehicles and hardware, noting 
that the proposed exemptions would be limited to the safety-critical, 
corrosion-sensitive components on aircraft and aerospace vehicles, 
including safety-critical components.
b. Certain Emergency Uses of Methylene Chloride for Which No 
Technically and Economically Feasible Safer Alternative Is Available
i. Analysis of the Need for TSCA Section 6(g)(2)(A) Exemption for NASA 
Certain Uses in an Emergency
    EPA also considered a TSCA section 6(g) exemption for emergency use 
of methylene chloride in the furtherance of NASA's mission. Under TSCA 
section 6(g)(1)(A), EPA may ``grant an exemption from a requirement of 
a . . . rule for a specific condition of use of a chemical substance or 
mixture, if the Administrator finds that the specific condition of use 
is a critical or essential use for which no technically and 
economically feasible safer alternative is

[[Page 28312]]

available, taking into consideration hazard and exposure.'' For certain 
specific conditions of use, EPA proposes that use of methylene chloride 
by NASA and its contractors in an emergency be exempt from the 
requirements of this rule because it is a critical or essential use 
provided that (1) there is an emergency; and (2) NASA selected 
methylene chloride because there are no technically or economically 
feasible safer alternatives available during the emergency.
    NASA operates on the leading edge of science seeking innovative 
solutions to future problems where even small volumes of an otherwise 
prohibited chemical substance could be vital to crew safety and mission 
success. During interagency review, NASA expressed concerns that there 
will likely be circumstances where a specific, EPA-prohibited condition 
of use may be identified by NASA during an emergency as being needed in 
order to avoid or reduce situations of harm or immediate danger to 
human health, or the environment, or avoid imperiling NASA space 
missions. In such cases, it is possible that no technically and 
economically feasible safer alternative would be available that meets 
the stringent technical performance requirements necessary to remedy 
harm or avert danger to human health, the environment, or avoid 
imperiling NASA space missions.
    An emergency is a serious and sudden situation requiring immediate 
action to remedy harm or avert danger to human health, the environment, 
or to avoid imperiling NASA space missions. In NASA's case, there may 
be instances where the emergency use of methylene chloride for specific 
conditions of use is critical or essential to remedying harm or 
averting danger to human health, the environment, or avoiding 
imperiling NASA space missions. Because of the immediate and 
unpredictable nature of emergencies described in this Unit and of the 
less forgiving environments NASA operates in that offer little to no 
margin for error, it is likely that, at the time of finalization of 
this proposal, alternatives to emergency methylene chloride use may not 
be available in a timely manner to avoid or reduce harm or immediate 
danger (Ref. 39). In this way, these emergencies for particular 
conditions of use meet the criteria for an exemption under TSCA section 
6(g)(1)(A), because the emergency use of methylene chloride for listed 
conditions of use is critical or essential and no technically and 
economically feasible safer alternative will be available in a timely 
manner, taking into consideration hazard and exposure.
    In support of the TSCA section 6(g)(1)(A) emergency use exemption, 
NASA submitted detailed criteria which they must use to screen, 
qualify, and implement materials to be used in spacecraft equipment, as 
well as historical case studies that outline the loss of life and loss 
of assets in the discharge of previous missions. In one of several 
examples detailed, the Apollo I command module fire that claimed the 
lives of three American astronauts demonstrated the need for careful 
testing and continuity of materials (Ref. 39). Moreover, due to NASA's 
rigorous safety testing requirements under various environmental 
conditions, technically and economically feasible safer alternatives 
may not be readily available during emergencies and may require certain 
conditions of use of methylene chloride to alleviate the emergency.
    In another example, NASA identified a scenario concerning a mission 
to the International Space Station (ISS) whereby, during a launch 
evolution, the countdown was paused immediately prior to launch (T-2 
minutes). NASA engineers identified a clogged filter and supply line as 
the primary issue, which required immediate attention (i.e., line 
flushing and filter cleaning). In this type of emergency scenario, an 
already approved chemical substance rated for space system applications 
is necessary to immediately remedy the situation. Although methylene 
chloride was not used in this particular incident, if it were needed, 
in the future to address such an emergency, then the proposed exemption 
would allow for its lawful use--the countdown would resume and the 
launch would occur. Conversely, without an exemption under the specific 
condition of use (e.g., industrial and commercial use in non-aerosol 
degreasers and cleaners), NASA's use of methylene chloride would be 
otherwise prohibited, which would put NASA in an untenable position of 
having to choose to either violate the law or place the mission (and 
potentially the health and safety of its employees involved in the 
mission) at risk.
    As described in Unit IV.A.5.a., the identification and 
qualification of compatible materials in the context of aviation is 
iterative and involves expansive collaboration between original 
equipment manufacturers, Federal agencies, and qualifying institutions. 
This is equally, if not more so, the case in the context of human space 
flight operations undertaken by NASA (Ref. 39). NASA's mission 
architecture requirements often are developed many years in advance of 
an actual launch occurring. As part of mission planning, space systems 
are designed, full scale mock-ups are built, and mission critical 
hardware is constructed using materials qualified for spaceflight. Once 
NASA's mission architecture requirements are developed, NASA may need 
to retain emergency access to methylene chloride because its 
alternatives may not have yet gone through NASA's rigorous 
certification process before their use. Allowing NASA to retain 
emergency use of methylene chloride would reduce the chances that this 
rule will hinder future space missions for which mission architecture 
infrastructure is being developed or is already built. While NASA 
considers alternatives to the chemical substances it currently uses in 
its space system designs, NASA has not yet identified technically and 
economically feasible alternatives to proven chemistries in many 
current applications. While EPA acknowledges that the use of methylene 
chloride in emergency situations may be necessary in the near term, it 
is also EPA's understanding that NASA will continue its work to 
identify and qualify alternatives to methylene chloride. Thus, as with 
the exemption described in Unit IV.A.5.a., EPA is proposing an 
exemption duration of 10 years.
ii. Proposed Exemption for Use of Methylene Chloride for Emergency Uses 
in the Context of Human Space Flight for Certain Uses
    For the reasons discussed in this Unit, EPA is proposing a 10-year 
exemption for emergency use of methylene chloride in furtherance of 
NASA's mission for the following specific conditions of use: Industrial 
and commercial use as solvent for cold cleaning; Industrial and 
commercial use as a solvent for aerosol spray degreaser/cleaner; 
Industrial and commercial use in adhesives, sealants and caulks; 
Industrial and commercial use in adhesive and caulk removers; 
Industrial and commercial use in metal non-aerosol degreasers; 
Industrial and commercial use in non-aerosol degreasers and cleaners; 
and Industrial and commercial use as solvent that becomes part of a 
formulation or mixture. EPA is also proposing to include additional 
requirements as part of the exemption, pursuant to TSCA section 
6(g)(4), including required notification and controls for exposure, to 
the extent feasible: (1) NASA and its contractors must provide notice 
to the EPA Administrator of each instance of emergency use within 15 
days and; (2) NASA and its contractors would have to comply with the 
WCPP described in Unit IV.A.1. to the extent feasible.

[[Page 28313]]

    EPA is proposing to require that NASA notify EPA within 15 days of 
the emergency use. The notification would include a description of the 
specific use of methylene chloride in the context of one of the 
conditions of use for which this exemption is being proposed, an 
explanation of why the use described qualifies as an emergency, and an 
explanation with regard to the lack of availability of technically and 
economically feasible alternatives.
    As with the exemption described in Unit IV.A.5.a., EPA expects NASA 
and its contractors have the ability to implement a WCPP as described 
in Unit IV.A.1. for the identified uses in the context of an emergency, 
to some extent even if not to the full extent of WCPP implementation. 
Therefore, EPA is proposing to require that during emergency use, NASA 
must comply with the WCPP to the extent technically feasible in light 
of the particular emergency.
    Under the proposed exemption, NASA and its contractors would still 
be subject to the proposed general recordkeeping requirements discussed 
in Unit IV.A.
    EPA requests comment on this TSCA section 6(g) exemption for 
continued emergency use of methylene chloride in the furtherance of 
NASA's mission as described in this Unit, and whether any additional 
conditions of use should be included, in particular for any uses 
qualified for space flight for which no technically or economically 
feasible safer alternative is available. Additionally, EPA requests 
comment on what would constitute sufficient justification of an 
emergency.
c. Analysis of the Need for a TSCA Section 6(g) Exemption for 
Commercial Furniture Refinishing
    While EPA in the past has proposed to exclude commercial furniture 
refinishing from regulation of the use of methylene chloride in 
commercial paint and coating removal, this proposed rule does not 
exclude commercial furniture refinishing from the proposed prohibition 
on the use of methylene chloride for commercial paint and coating 
removal, because EPA has determined that this use drives the 
unreasonable risk for methylene chloride, reasonably available 
information demonstrates that alternative methods or substitute 
chemicals are available to some extent, and, based on reasonably 
available information, EPA has not found that a TSCA section 6(g) 
exemption is warranted for the use of methylene chloride in commercial 
furniture refinishing.
    The 2020 Risk Evaluation for Methylene Chloride identified risks 
for commercial use of methylene chloride in paint and coating removal, 
including furniture refinishing, as a result of acute and chronic non-
cancer exposures that would not be mitigated by an APF 50 respirator. 
The 2020 Risk Evaluation for Methylene Chloride identified risks for 
commercial use of methylene chloride in paint and coating removal, 
including furniture refinishing, as a result of acute and chronic non-
cancer exposures that would not be mitigated by an APF 50 respirator. 
EPA identified many alternative products for paint and coating 
removers. However, some may require longer periods of time or rework of 
equipment and processes in order to work for furniture refinishing 
uses, or, though they may be used as paint and coating removers in 
other contexts, may not be appropriate alternatives for use on wood 
substrates. EPA's consideration of alternatives, including for safety 
and flammability, is discussed further in Unit V.B., the Economic 
Analysis, and Alternatives Assessment (Ref. 3, Ref. 40). Mechanical or 
thermal methods (i.e., sanding, media blasting, or heat guns) are also 
potential alternatives for this sector, though likewise they may damage 
the substrate, require different processes, and often requires more 
time (Refs. 33, 55, 66). While the economic impacts of prohibiting the 
commercial use of methylene chloride for furniture refinishing may be 
significant for this sector, it is unclear whether this will result in 
firm closures, and, if so, how many. Given the magnitude of the risks 
resulting from this use, including the documented fatalities (Ref. 32), 
the likely inability of this sector to comply with a WCPP (as described 
in Unit V.A.), and the availability of some alternatives, EPA 
determined that a prohibition would be necessary the identified risks 
that drive the unreasonable risk to health, as discussed in Unit V.A.1. 
EPA requests comment on all aspects of this preliminary determination 
that a TSCA section 6(g) exemption is not warranted for the use of 
methylene chloride in furniture refinishing, including information on 
the availability of alternatives and the time needed to implement 
alternatives. EPA emphasizes that the Agency is seeking input regarding 
whether an exemption is needed and welcomes information related to this 
condition of use during the public comment period.

B. Primary Alternative Regulatory Action

    As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA 
must consider the costs and benefits and the cost effectiveness of the 
proposed regulatory action and one or more primary alternative 
regulatory actions considered by the Agency. An overview of the 
proposed regulatory action and alternative regulatory action for each 
condition of use is in Unit IV.C.
    The primary alternative regulatory action described in this notice 
combines prohibitions and requirements for a WCPP to address the 
unreasonable risk from methylene chloride driven by the various 
conditions of use, as well as time-limited exemptions under TSCA 
section 6(g) for two uses. While in some ways it is similar to the 
proposed regulatory action, the primary alternative regulatory action 
described in this notice would allow a WCPP, including requirements to 
meet an ECEL and EPA STEL, for several additional conditions of use 
than would be allowed under the proposed regulatory action. The 
alternative regulatory action additionally would include longer 
compliance timeframes for prohibitions and a WCPP, as described in this 
Unit.
    As in the proposed regulatory action described in Unit IV.A.1., 
EPA's primary alternative regulatory action described in this notice 
would include WCPP, including requirements to meet an ECEL and EPA STEL 
for: manufacturing: domestic manufacture; manufacturing: import; 
processing: as a reactant; processing: incorporation into a 
formulation, mixture, or reaction product; processing: repackaging; 
processing: recycling; industrial and commercial use as a laboratory 
chemical; and disposal.
    In addition, the primary alternative regulatory action described in 
this notice would require a WCPP for additional industrial and 
commercial conditions of use: industrial and commercial use in 
finishing products for fabric, textiles, and leather; industrial and 
commercial use as solvent that becomes part of a formulation or 
mixture; industrial and commercial use as a processing aid; industrial 
and commercial use for electrical equipment, appliance, and component 
manufacturing; industrial and commercial use for plastic and rubber 
products manufacturing; industrial and commercial use in cellulose 
triacetate film production; industrial and commercial use for oil and 
gas drilling, extraction, and support activities; and industrial and 
commercial use in paint or coating removal from safety-critical, 
corrosion-sensitive components of aircraft owned or operated by air 
carriers or commercial operators certificated under 14 CFR part 119.

[[Page 28314]]

    EPA believes a WCPP may be a viable alternative to the proposed 
prohibition for these additional industrial and commercial conditions 
of use because, as discussed in Unit V.A., these conditions of use are 
generally industrial in nature; owners or operators are likely 
currently complying with the OSHA methylene chloride standard, so they 
should be familiar with what is being required to meet the ECEL; and, 
as far as the Agency is aware, these conditions of use have not 
resulted in any documented fatalities. Because of the industrial nature 
of the sectors relevant to these conditions of use, the owner or 
operator may have the capability to successfully implement a WCPP to 
ensure that the unreasonable risk, as a result of exposure to methylene 
chloride, are prevented. However, at the time of proposal, EPA has not 
yet received any monitoring data or detailed description of methylene 
chloride involving activities for these conditions of use to confirm 
that compliance with an ECEL of 2 ppm is possible. Therefore, concerns 
about the feasibility of implementing an ECEL for these additional 
industrial and commercial conditions of use, as discussed in Unit V.3., 
led EPA to propose that they be prohibited (see Unit IV.A.2.). EPA does 
not have sufficient information to confidently conclude that facilities 
engaged in these conditions of use could meet the ECEL for methylene 
chloride.
    Therefore, EPA requests comment on the ways in which methylene 
chloride may be used in the conditions of use that would be prohibited 
(under the proposed regulatory action) due to concerns about 
feasibility of implementing an ECEL, and the degree to which users of 
methylene chloride in these sectors could successfully implement the 
WCPP, including requirements to meet an ECEL and EPA STEL, described in 
Unit IV.A.1. EPA is also requesting comment on whether to consider a 
regulatory alternative that would subject more conditions of use to a 
WCPP, instead of prohibition, than those currently contemplated in the 
primary alternative regulatory action. EPA also requests monitoring 
data and detailed descriptions of methylene chloride involving 
activities for these conditions of use to determine whether these 
additional conditions of use could comply with the WCPP such that risks 
are no longer unreasonable.
    Specifically with regards to the condition of use ``Industrial and 
commercial use as a processing aid,'' EPA notes that the description of 
this condition of use (in Unit III.B.1.c.xxiii.) covers a broad range 
of chemical use activities. During the SBAR Panel, one SER provided 
process descriptions, diagrams, and monitoring data which indicated 
that particular entity may already be able to meet an ECEL of 2 ppm. 
This particular entity uses methylene chloride as a heat transfer fluid 
in a closed system. Information provided to EPA indicated that 
inhalation exposures were frequently below the ECEL and in some cases 
below the level of detection, and while dermal exposure were possible, 
they could be mitigated through use of PPE (Ref. 6). EPA's 2020 Risk 
Evaluation for Methylene Chloride incorporated exposure estimates from 
a different type of processing aid application that did not resemble 
the SER's use, which is highly specialized and may be considered a sub-
use of the condition of use as a whole. EPA requests comment on the 
degree to which other entities using methylene chloride as a processing 
aid may otherwise comply with the proposed WCPP requirements for 
methylene chloride. In the case that several entities are able to 
demonstrate the continued use of methylene chloride without subjecting 
workers to unreasonable risk is possible, through a combination of 
monitoring data and process description, EPA acknowledges its 
willingness to finalize a regulation under which this particular sub-
use of the condition of use, or the condition of use as a whole could 
continue under the WCPP.
    Additionally, EPA notes that the alternatives analysis did not 
specifically identify any alternatives for this condition of use (Ref. 
40). This is a limitation of the type of analysis done, which was 
specifically based on the use of alternative formulations currently on 
the market, and therefore not applicable to most processing uses. EPA 
emphasizes that this is not a positive finding that alternatives do not 
exist for this condition of use. To that end, EPA requests comment on 
the degree to which alternatives may or may not be available for use of 
methylene chloride as a heat transfer fluid and in other processing aid 
applications.
    In the event that EPA is not able to identify any alternatives for 
this condition of use, and additional information is not provided that 
would allow EPA to determine that the WCPP could address unreasonable 
risk driven by this condition of use, EPA will consider finalizing a 
prohibition that allows for an appropriate phaseout in accordance with 
TSCA section 6(d). Alternatively, in the event that EPA is unable to 
identify alternatives for this condition of use, and EPA determines 
through new information provided that prohibition of the use would 
significantly impact national security or critical infrastructure, EPA 
will consider an exemption under TSCA section 6(g).
    Under the primary alternative regulatory action, EPA would prohibit 
the manufacture, processing, and distribution in commerce of methylene 
chloride for all consumer use. Additionally, under the primary 
alternative regulatory action described in this notice and considered 
by EPA, other than those conditions of use listed earlier for inclusion 
under the WCPP, EPA would prohibit the remaining industrial and 
commercial uses, including two uses for which EPA is proposing the WCPP 
as the regulatory action: industrial or commercial use for paint and 
coating removal from safety-critical, corrosion-sensitive components of 
aircraft and spacecraft by Federal agencies and their contractors; and 
industrial or commercial use as a bonding agent in the production of 
specialty batteries for military or space applications by Federal 
agencies and their contractors. Recordkeeping and downstream 
notification would be required as described in Unit IV.A.4.
    For industrial or commercial use for paint and coating removal from 
safety-critical, corrosion-sensitive components of aircraft and 
spacecraft by Federal agencies and their contractors, and industrial or 
commercial use as a bonding agent in the production of specialty 
batteries for military or space applications by Federal agencies and 
their contractors, the alternative regulatory action would include an 
exemption from the prohibition for 10 years under TSCA section 6(g). 
For the duration of this exemption, regulated entities would be 
required to comply with the WCPP to the extent practicable.
    For these two uses, EPA has conducted an analysis of the 
application of this rulemaking and found that a TSCA section 6(g) 
exemption may be warranted if the primary alternative regulatory action 
considered by EPA is adopted, in its entirety or in relevant part, in 
the final rule. Based on discussions with and information provided by 
industry stakeholders, EPA understands that these two uses of methylene 
chloride by DoD, NASA, and other Federal agencies are essential for 
national security and critical infrastructure.
    As discussed in greater detail in Unit V.B., EPA is aware that 
there are specific military uses for which methylene chloride is 
essential for paint and coating removal and for which there are no 
suitable alternatives currently available. The military readiness of 
DOD's warfighting capability is

[[Page 28315]]

paramount to ensuring national security, which includes ensuring the 
maintenance and preservation of DOD's warfighting assets. DOD has 
identified safety-critical uses of methylene chloride for ensuring 
military aviation readiness. These consist of the use of methylene 
chloride for the removal of coatings from safety-critical, corrosion-
sensitive military aviation components, such as landing gear, gear 
boxes, and turbine engine parts, that not only require their coatings 
be removed for inspection and maintenance but also would be so 
negatively affected by the use of technically incompatible, substitute 
paint removal chemicals or methods that the safe performance of the 
aircraft could be compromised.
    EPA has evaluated the effect that a prohibition on methylene 
chloride for industrial or commercial paint and coating removal could 
have on military readiness and preliminarily determines that an 
exemption would be warranted under TSCA section 6(g)(1)(B) to avoid the 
significant deleterious impacts on national security that compliance 
with the proposed prohibition could entail, should the primary 
alternative regulatory action be adopted in the final rule in whole or 
in part. More specifically, because the available alternatives either 
cannot be used on certain substrates, such as high-strength steel or 
magnesium, or take an unacceptably long time to work in certain 
situations, compliance with the proposed prohibition would result in 
important military assets being off-line for significantly longer 
inspection and repair periods, which would significantly disrupt 
national security.
    In addition, as noted by commenters on EPA's 2017 NPRM, there are 
other Federal agencies that use safety-critical, corrosion-sensitive 
components on aviation and space applications and stated that the 
proposed exemption should also apply to those Federal agencies and 
their contractors. These commenters asserted that, without an exemption 
for NASA, the Department of Homeland Security (DHS), and the Federal 
Aviation Administration (FAA), the proposed prohibition on the use of 
methylene chloride for industrial or commercial paint and coating 
removal could negatively affect national security and critical 
infrastructure.
    EPA's analysis of the potential impacts on DOD's military readiness 
and national security is equally applicable to NASA, DHS, and FAA. As 
stated by commenters on EPA's 2017 NPRM (Ref. 46), aircraft and other 
assets operated by DHS, NASA, and the FAA also contain safety-critical, 
corrosion-sensitive components of the type described by DOD, and 
suitable alternatives to methylene chloride are similarly not available 
for all applications. Those agencies are also responsible for assets 
that are essential to national security or constitute critical 
infrastructure and contain safety-critical, corrosion-sensitive 
components on which methylene chloride is used for paint and coating 
removal. The Coast Guard, one of the five Armed Services of the United 
States, is a military branch within DHS. Like the four Armed Services 
within DOD, the Coast Guard is also responsible for warfighting assets 
that may require the use of methylene chloride for the removal of 
coatings from safety-critical, corrosion-sensitive components. The 
Coast Guard's military readiness is as important as the military 
readiness of the four Armed Services within DOD. Similarly, the 
readiness of U.S. Customs and Border Protection aviation for monitoring 
and protecting the borders of the United States is an integral part of 
national security. As for NASA, the United States Space Priorities 
Framework notes that space systems (e.g., flight components of 
satellites and space craft) are part of the nation's critical 
infrastructure and that the United States has significant national 
security interests in space (Ref. 41). The integrity and performance of 
our national airspace system, overseen by the FAA, is a matter of both 
national security and critical infrastructure. FAA-operated aircraft 
ensure the integrity of instrument approaches to airports and airway 
procedures that constitute our National Airspace System infrastructure 
(Ref. 42). The FAA's Flight Program Operations accomplishes this 
through the airborne inspection of space- and ground-based instrument 
flight procedures and the validation of electronic signals in space 
transmitted from ground navigation systems, evaluating accuracy, 
aeronautical data, human factors fly-ability, and obstacle clearance.
    As discussed in Unit V.B., substitute chemicals for paint and 
coating removal for safety-critical, corrosion-sensitive components are 
not technically feasible as they have one or more technical 
limitations; are incompatible with underlying materials; and/or do not 
support the coating removal requirements of safety inspections, non-
destructive inspection, material assessment, or field repair processes. 
Therefore, EPA has preliminarily determined that DHS, NASA, and FAA 
compliance with a prohibition on the use of methylene chloride for 
industrial or commercial paint and coating removal, which would 
preclude use of methylene chloride for removal of paint and coatings 
from safety-critical, corrosion-sensitive components of these agencies' 
aircraft and other assets, would significantly disrupt national 
security and critical infrastructure in the same way that DOD's 
compliance with a prohibition would. In addition, due to concerns about 
impacts to the availability of methylene chloride for use in removing 
paint and coatings from safety-critical, corrosion-sensitive 
components, EPA has preliminarily determined that a ban on the 
manufacture, processing, and distribution in commerce of methylene 
chloride for industrial or commercial paint and coating removal for 
these safety-critical, corrosion-sensitive components would also 
significantly disrupt national security and critical infrastructure. 
For this reason, if the primary alternative regulatory action 
considered by EPA is adopted, in its entirety or in relevant part, in 
the final rule, an exemption under TSCA section 6(g) would be warranted 
to prevent significant disruption of national security and critical 
infrastructure.
    EPA has also analyzed the need for a TSCA section 6(g) exemption 
for use of methylene chloride as a bonding agent in the production of 
specialty batteries for use in critical energy storage applications in 
military and space exploration settings, including defense applications 
such as precision guided weapons, military airframes, satellites, space 
launch vehicles, and spacecraft. According to a maker of these 
batteries, all major military and space applications, such as aircraft 
(F-35, B2), radios, and Mars mission equipment, require these batteries 
to function in very harsh conditions, including operation to -40 [deg]C 
and storage at -54 [deg]C (Ref. 47). As discussed further in Unit V.B., 
EPA understands that methylene chloride is a superior bonding agent for 
this process because of its unique evaporative qualities, and that 
availability of technologically and economically feasible alternatives 
to methylene chloride is lacking.
    As discussed in this Unit, EPA recognizes that military readiness 
is paramount to ensuring national security, and that space systems are 
part of our critical infrastructure and have impacts on national 
security. Therefore, EPA has preliminarily determined that DOD and NASA 
compliance with a prohibition on the use of methylene chloride as a 
bonding agent in the production of specialty batteries for use in 
critical energy storage applications in military and space exploration 
settings would significantly disrupt national security and critical 
infrastructure,

[[Page 28316]]

should the primary alternative regulatory action be adopted in the 
final rule in whole or in part. In addition, due to concerns about 
impacts to the availability of methylene chloride for use as a bonding 
agent in the production of these specialty batteries, EPA has 
preliminarily determined that a prohibition on the manufacture, 
processing, and distribution in commerce of methylene chloride for use 
as a bonding agent in the production of specialty batteries for use in 
critical energy storage applications in military and space exploration 
settings would also significantly disrupt national security and 
critical infrastructure. For this reason, if the primary alternative 
regulatory action considered by EPA is adopted, in its entirety or in 
relevant part, in the final rule, an exemption under TSCA section 6(g) 
would be warranted to prevent significant disruption of national 
security and critical infrastructure.
    Given the potential severity of impacts from acute exposures, EPA's 
proposed regulatory action would include relatively rapid compliance 
timeframes. However, it is possible that longer timeframes would be 
needed for entities to come into compliance; therefore, the primary 
alternative regulatory action described in this notice would include 
longer timeframes for implementation than the proposed regulatory 
action. The prohibitions under the primary alternative regulatory 
action would take effect in 360 days for manufacturers, 450 days for 
processers, 540 days for distributing to retailers, 630 days for all 
other distributors and retailers, and 720 days for industrial and 
commercial users after publication of the final rule in the Federal 
Register (in contrast to 90 days for manufacturers, 180 days for 
processers, 270 days for distributing to retailers, 360 days for all 
other distributors and retailers, and 450 days for industrial and 
commercial users after publication of the final rule in the Federal 
Register in the proposed action described in Unit IV.A.). Similarly, 
the compliance timeframes for the WCPP under the primary alternative 
regulatory action would be extended by 6 months in comparison to the 
proposed action described in Unit IV.A: EPA would require that 
regulated entities establish initial exposure monitoring according to 
the process outlined in Unit IV.A. within 12 months, ensure that the 
airborne concentration of methylene chloride does not exceed the ECEL 
or EPA STEL within 15 months (and provide respiratory protection if 
necessary), and implement an exposure control plan within 18 months. 
EPA requests comment on the ability of regulated entities engaged in 
the additional conditions of use that would be subject to a WCPP under 
the primary alternative regulatory action to conduct initial monitoring 
within 12 months, anticipated timelines for any procedural adjustments 
needed to comply with the requirements, and the extent to which this 
option could result in additional exposure, compared the proposed 
regulatory option as described in Unit IV.A. Overall, EPA requests 
comment on any advantages or drawbacks for the timelines outlined in 
this Unit, compared to the timelines identified for the proposed 
regulatory action in Unit IV.A.
    As noted earlier in this Unit, for some conditions of use, both the 
proposed regulatory action and primary alternative regulatory action 
would result in a prohibition. EPA emphasizes that for those conditions 
of use, the primary alternative regulatory action includes a different 
timeline for implementation of the prohibition, in comparison to the 
proposed regulatory action. As discussed in more detail in Unit V.A., 
for those conditions of use, EPA also considered other regulatory 
approaches available under TSCA section 6(a). However, EPA found that 
none of these other regulatory approaches would address the 
unreasonable risk.
    Where EPA has determined that a chemical substance presents 
unreasonable risk under TSCA section 6(b)(4), EPA must undertake 
rulemaking to ``apply one or more of the [TSCA Sec.  6(a)(1) through 
(7)] requirements to such substance . . . to the extent necessary so 
that the chemical substance . . . no longer presents such risk.'' TSCA 
Sec.  6(a). ``In proposing and promulgating [such] a rule,'' EPA must 
``consider and publish a statement based on reasonably available 
information with respect to . . . the reasonably ascertainable economic 
consequences of the rule, including consideration of . . . (II) the 
costs and benefits of the proposed . . . regulatory action and of the 
[one] or more primary alternative regulatory actions considered by 
[EPA]; and (III) the cost effectiveness of the proposed regulatory 
action and of the [one] or more primary alternative regulatory actions 
considered by [EPA].'' EPA interprets this to mean that Congress 
intended this ``primary alternative regulatory action'' to be another 
regulatory option under TSCA Sec.  6(a)(1) through (7) that would meet 
the requirements of TSCA Sec.  6(a), namely address the unreasonable 
risk identified under TSCA section 6(b)(4) ``to the extent necessary so 
that the chemical substance . . . no longer presents such risk.'' Here, 
the proposed regulatory action is comprised of a mix of proposed 
options under TSCA section 6(a), each directed at specific conditions 
of use and with specified timeframes for compliance. The primary 
alternative regulatory options considered by the Agency would adjust 
the overall mix of TSCA section 6(a) requirements, including compliance 
timeframes, resulting in a proposed regulatory action that is more 
restrictive in some ways and less restrictive in others. For conditions 
of use where the only options that would address the unreasonable risk 
are prohibition options under TSCA Sec.  6(a)(2), the proposed option 
and the primary alternative regulatory option are distinct because 
implementing prohibitions on differing timetables under TSCA section 
6(d) would result in a different mix of regulatory options with 
different costs, benefits, and cost effectiveness than the proposed 
regulatory action.

C. Overview of Conditions of Use and Proposed Regulatory Action and 
Primary Alternative Regulatory Action

    The following Table 3 is a side-by-side depiction of the proposed 
regulatory action with the primary alternative regulatory action for 
each condition of use. Additionally, timeframes between the proposed 
and primary alternative regulatory action differ as outlined in Units 
IV.A. and B; those Units also contain additional details such as 
exemptions proposed under TSCA section 6(g) and delayed compliance 
dates under TSCA section 6(d) for specific applications.

[[Page 28317]]



     Table 3--EPA Proposed or Alternative Action by Condition of Use
------------------------------------------------------------------------
                                                   Action
                                  --------------------------------------
         Condition of use                                   Primary
                                        Proposed          alternative
                                    regulatory action        action
------------------------------------------------------------------------
Industrial and commercial use as   Prohibit..........  Prohibit.
 solvent for batch vapor
 degreasing.
Industrial and commercial use as   Prohibit..........  Prohibit.
 solvent for in-line vapor
 degreasing.
Industrial and commercial use as   Prohibit..........  Prohibit.
 solvent for cold cleaning.
Industrial and commercial use as   Prohibit..........  Prohibit.
 a solvent for aerosol spray
 degreaser/cleaner.
Industrial and commercial use in   Prohibit..........  Prohibit.
 adhesives, sealants and caulks.
Industrial and commercial use in   Prohibit..........  Prohibit.
 paints and coatings.
Industrial and commercial use in   Prohibit..........  Prohibit.
 paint and coating removers.
Industrial and commercial use in   WCPP..............  Prohibit, with a
 paint and coating removers from                        10-year time-
 safety critical, corrosion-                            limited
 sensitive components of aircraft                       exemption and
 and spacecraft owned or operated                       interim WCPP.
 by DOD, NASA, DHS, FAA.
Industrial and commercial use in   Prohibit, with a    WCPP.
 paint and coating removers from    10-year time-
 safety-critical, corrosion-        limited exemption
 sensitive components of aircraft   and interim WCPP.
 owned or operated by air
 carriers or commercial operators.
Industrial or commercial use as a  WCPP..............  Prohibit, with a
 bonding agent for acrylic and                          10-year time-
 polycarbonate in mission-                              limited
 critical military and space                            exemption and
 vehicle applications, including                        interim WCPP.
 in the production of specialty
 batteries for such applications.
Industrial and commercial use in   Prohibit..........  Prohibit.
 adhesive and caulk removers.
Industrial and commercial use in   Prohibit..........  Prohibit.
 metal aerosol degreasers.
Industrial and commercial use in   Prohibit..........  Prohibit.
 metal non-aerosol degreasers.
Industrial and commercial use in   Prohibit..........  WCPP.
 finishing products for fabric,
 textiles and leather.
Industrial and commercial use in   Prohibit..........  Prohibit.
 automotive care products
 (functional fluids for air
 conditioners).
Industrial and commercial use in   Prohibit..........  Prohibit.
 automotive care products
 (interior car care).
Industrial and commercial use in   Prohibit..........  Prohibit.
 automotive care products
 (degreasers).
Industrial and commercial use in   Prohibit..........  Prohibit.
 apparel and footwear care
 products.
Industrial and commercial use in   Prohibit..........  Prohibit.
 spot removers for apparel and
 textiles.
Industrial and commercial use in   Prohibit..........  Prohibit.
 liquid lubricants and greases.
Industrial and commercial use in   Prohibit..........  Prohibit.
 spray lubricants and greases.
Industrial and commercial use in   Prohibit..........  Prohibit.
 aerosol degreasers and cleaners.
Industrial and commercial use in   Prohibit..........  Prohibit.
 non-aerosol degreasers and
 cleaners.
Industrial and commercial use in   Prohibit..........  Prohibit.
 cold pipe insulations.
Industrial and commercial use as   Prohibit..........  WCPP.
 solvent that becomes part of a
 formulation or mixture.
Industrial and commercial use as   Prohibit..........  WCPP.
 a processing aid.
Industrial and commercial use as   Prohibit..........  Prohibit.
 a propellant and blowing agent.
Industrial and commercial use for  Prohibit..........  WCPP.
 electrical equipment, appliance,
 and component manufacturing.
Industrial and commercial use for  Prohibit..........  WCPP.
 plastic and rubber products
 manufacturing.
Industrial and commercial use in   Prohibit..........  WCPP.
 cellulose triacetate film
 production.
Industrial and commercial use as   Prohibit..........  Prohibit.
 anti-spatter welding aerosol.
Industrial and commercial use for  Prohibit..........  WCPP.
 oil and gas drilling,
 extraction, and support
 activities.
Industrial and commercial use in   Prohibit..........  Prohibit.
 toys, playground and sporting
 equipment.
Industrial and commercial use in   Prohibit..........  Prohibit.
 carbon remover, wood floor
 cleaner, and brush cleaner.
Industrial and commercial use in   Prohibit..........  Prohibit.
 lithographic printing plate
 cleaner.
Consumer use as solvent in         Prohibit\1\.......  Prohibit.\1\
 aerosol degreasers/cleaners.
Consumer use in adhesives and      Prohibit \1\......  Prohibit.\1\
 sealants.
Consumer use in brush cleaners     Prohibit \1\......  Prohibit.\1\
 for paints and coatings.
Consumer use in adhesive and       Prohibit \1\......  Prohibit.\1\
 caulk removers \1\.
Consumer use in metal degreasers.  Prohibit \1\......  Prohibit.\1\
Consumer use in automotive care    Prohibit \1\......  Prohibit.\1\
 products (functional fluids for
 air conditioners).
Consumer use in automotive care    Prohibit \1\......  Prohibit.\1\
 products (degreasers).
Consumer use in lubricants and     Prohibit \1\......  Prohibit.\1\
 greases.
Consumer use in cold pipe          Prohibit \1\......  Prohibit.\1\
 insulation.
Consumer use in arts, crafts, and  Prohibit \1\......  Prohibit.\1\
 hobby materials glue.
Consumer use in an anti-spatter    Prohibit \1\......  Prohibit.\1\
 welding aerosol.
Consumer use in carbon removers    Prohibit \1\......  Prohibit.\1\
 and other brush cleaners.
Manufacturing (Domestic            WCPP..............  WCPP.
 manufacturing).
Manufacturing (Import)...........  WCPP..............  WCPP.
Processing: processing as a        WCPP..............  WCPP.
 reactant.
Processing: incorporation into a   WCPP..............  WCPP.
 formulation, mixture, or
 reaction product.
Processing: repackaging..........  WCPP..............  WCPP.
Processing: recycling............  WCPP..............  WCPP.
Industrial and commercial use as   WCPP..............  WCPP.
 a laboratory chemical.
Disposal.........................  WCPP..............  WCPP.
------------------------------------------------------------------------
\1\ Prohibit manufacture, processing, and distribution in commerce for
  the consumer use.


[[Page 28318]]

V. Rationale for the Proposed Regulatory and Primary Alternative 
Regulatory Actions

    This Unit describes how the considerations described in Unit 
III.B.3. were applied when selecting among the TSCA section 6(a) 
requirements to arrive at the proposed and primary alternative 
regulatory actions described in Unit IV.A. and B.

A. Consideration of Risk Management Requirements Available Under TSCA 
Section 6(a)

1. Workplace Chemical Protection Program (WCPP)
    One option EPA considered for occupational conditions of use was 
establishing a WCPP, which would include an ECEL and related required 
implementation measures, such as monitoring. As described in Unit 
IV.A.1., the WCPP for methylene chloride would be non-prescriptive, in 
the sense that owners and operators would not be required to use 
specific equipment or engineering controls prescribed by EPA to achieve 
the exposure concentration limit. Rather, a performance-based exposure 
limit would enable owners and operators to determine how to most 
effectively meet the exposure limits based on conditions at their 
workplace, aligned with the hierarchy of controls. However, due to the 
low exposure levels and stringent requirements in the WCPP necessary to 
address the unreasonable risk from methylene chloride, EPA identified 
only a relatively small number of conditions of use where the Agency 
expects the WCPP can be successfully implemented.
    The central components of the WCPP are the ECEL and EPA STEL. EPA 
has determined as a matter of risk management policy that ensuring 
exposures remain at or below the ECEL and EPA STEL would eliminate any 
unreasonable risk of injury to health driven by inhalation exposures 
for occupational conditions of use subject to the WCPP.
    In the case of methylene chloride, EPA has calculated the ECEL for 
methylene chloride to be 2 ppm (8 mg/m\3\) for inhalation exposures as 
an 8-hour TWA in workplace settings, based on the chronic non-cancer 
human equivalent concentration for liver toxicity from inhalation 
exposures. This is the concentration at which an adult human, including 
a member of a susceptible subpopulation, would be unlikely to suffer 
adverse effects if exposed for a working lifetime (Ref. 11). EPA chose 
the chronic non-cancer liver toxicity endpoint as the basis for this 
exposure limit as it is the most sensitive of the endpoints identified, 
and therefore will be protective of both acute and chronic cancer 
inhalation endpoints over the course of a working day and lifetime.
    However, the well-established and severe acute hazard identified 
for methylene chloride, from blurred vision to death, can be 
experienced in much shorter timeframes. Therefore, EPA determined a 
short-term exposure limit, or EPA STEL, of 16 ppm (57 mg/m\3\) as a 15-
minute TWA, based on the non-cancer endpoint of central nervous system 
depression resulting from acute exposures, was necessary in order to 
ensure the unreasonable risk was fully addressed in occupational 
settings (Ref. 11).
    Once EPA identified the appropriate risk-based inhalation limits to 
address identified unreasonable risk, EPA carefully considered the 
appropriateness of such a program for each occupational condition of 
use of methylene chloride, in the context of the unreasonable risk.
    Particular factors related to work activities that may make it 
difficult for certain conditions of use to comply with an ECEL are 
worth further discussion. One example includes work activities that may 
take place in the field, such as on-site paint removal or the use of 
adhesives in construction or renovation, making it challenging to 
establish a regulated area and conduct monitoring. In other contexts, 
the donning of air-supplied respirators would create challenges for 
movement and feasibility of work activities that may take place in 
small, enclosed spaces. Similarly, work activities that require a high 
range of motion or for some other reason could create challenges for 
the implementation of respiratory PPE are not good candidates for a 
WCPP, such as use as an anti-spatter welding aerosol, where use of a 
welding mask would impede the donning of an air-supplied respirator.
    EPA also considered the feasibility of exposure reduction 
sufficient to address the unreasonable risk, even in facilities 
currently complying with the OSHA methylene chloride standard. While 
EPA acknowledges the regulated community's expected familiarity with 
OSHA PELs generally, as well as facilities' past and ongoing actions to 
implement the methylene chloride PEL and corresponding methods of 
compliance in OSHA's methylene chloride standard, EPA's exposure limits 
would be a full order of magnitude lower than the OSHA PEL. (The 
differences between the ECEL and EPA STEL and the OSHA PEL are 
discussed in more detail in Unit II.C.4.) This creates a significant 
amount of uncertainty as to the ability of facilities engaging in most 
industrial and commercial conditions of use to meet the ECEL and EPA 
STEL (and associated action levels) without relying on the use of PPE 
(or as discussed previously, if the nature of the activity precludes 
use of PPE required to meet such a level), and, therefore, whether 
exposures could be reduced in a manner aligned with the hierarchy of 
controls, because under that hierarchy PPE is considered a measure of 
last resort.
    EPA understands that this uncertainty extends to the applicability 
of respirators as well. Although respirators, specifically SCBAs, could 
reduce exposures to levels that are protective of non-cancer and cancer 
risks, not all workers may be able to wear respirators. Individuals 
with impaired lung function due to asthma, emphysema, or chronic 
obstructive pulmonary disease, for example, may be physically unable to 
wear a respirator. OSHA requires that a determination regarding the 
ability to use a respirator be made by a physician or other licensed 
health-care professional, and annual fit testing is required for tight-
fitting, full-face piece respirators to provide the required 
protection. Individuals with facial hair, such as beards or sideburns 
that interfere with a proper face-to-respirator seal, cannot wear tight 
fitting respirators. In addition, respirators may also present 
communication problems, vision problems, worker fatigue, and reduced 
work efficiency (63 FR 1152, January 8, 1998). According to OSHA, 
``improperly selected respirators may afford no protection at all (for 
example, use of a dust mask against airborne vapors), may be so 
uncomfortable as to be intolerable to the wearer, or may hinder vision, 
communication, hearing, or movement and thus pose a risk to the 
wearer's safety or health'' (63 FR 1189 through 1190).
    In contrast to considerations that would weigh against the 
likelihood of a facility within a condition of use to successfully 
implement WCPP, there are certain considerations that indicate a 
condition of use is a good fit for effective risk management via WCPP. 
Based on reasonably available information, including monitoring data, 
and information related to considerations described previously in this 
Unit, EPA's confidence that requirements to meet an ECEL and EPA STEL 
can be implemented is highest for highly standardized and 
industrialized settings, such as where methylene chloride is used in a 
closed system.

[[Page 28319]]

    For example, one of the conditions of use for which EPA is 
proposing to require compliance with the WCPP is processing of 
methylene chloride as a reactant. A large volume of methylene chloride 
is processed for this condition of use, which almost entirely goes 
towards the manufacture of the hydrofluorocarbon HFC-32 (Refs. 3, 44). 
Monitoring data and exposure information submitted by industry, 
including by small entity representatives as part of the SBAR process, 
suggests that methylene chloride exposures in some facilities may 
already be below levels that would be consistent with the proposed ECEL 
(Refs. 6, 45, 46). Additionally, HFC-32 is one of the regulated 
substances identified in the AIM Act. Among other things, the AIM Act 
authorizes EPA to address listed HFCs in three main ways: phasing down 
HFC production and consumption through an allowance allocation program; 
facilitating sector-based transitions to next-generation technologies; 
and issuing certain regulations for purposes of maximizing reclamation 
and minimizing releases of HFCs and their substitutes from equipment 
and ensuring the safety of technicians and consumers. EPA anticipates 
that many entities currently using HFCs with higher global warming 
potential will transition to alternatives with lower global warming 
potential as requirements under the AIM Act take effect. HFC-32, while 
being one regulated substance subject to the overall phasedown in 
production and consumption of regulated substances under the AIM Act, 
is likely to be used to facilitate the transition from other HFCs and 
HFC blends with higher global warming potential in certain 
applications. By allowing for the continued, controlled use of 
methylene chloride in the manufacture of HFC-32, efforts to shift to 
chemicals with lower global warming potential would not be impeded by 
this rulemaking. Allowing this use to continue, subject to compliance 
with the WCPP, would complement industry's ongoing effort to abate the 
use of hydrofluorocarbons with higher global warming potential.
    An additional strong candidate for WCPP is industrial and 
commercial use of methylene chloride as a laboratory chemical. 
Laboratory settings are expected to be more conducive to the 
implementation of engineering controls such as fume hoods to ventilate 
vapors and adequately reduce overall exposure to methylene chloride 
consistent with the hierarchy of controls.
    For both these conditions of use (processing of methylene chloride 
as a reactant and industrial and commercial use as a laboratory 
chemical), the 2020 Risk Evaluation for Methylene Chloride indicates 
that only small reductions in exposure are needed for WCPP compliance. 
Based on analysis in the 2020 Risk Evaluation for Methylene Chloride 
describing expected exposures with and without use of PPE, EPA 
identified an air-supplied respirator of APF 25 as the minimum 
respiratory PPE that is sufficient to mitigate the unreasonable risk 
driven by both of these conditions of use (note for OSHA APF 25 is the 
minimum allowable respiratory PPE for methylene chloride, as filter and 
cartridge respirators are not protective against methylene chloride 
vapors). This suggested that, for these conditions of use, the 
reductions in exposure required to achieve a level that would not 
present unreasonable risk may be less than in other instances, which, 
together with other considerations previously described, including 
monitoring data indicating exposures near or below the ECEL, adds to 
EPA's confidence that facilities engaging in these two conditions of 
use could meet the WCPP requirements. Additionally, industrial and 
commercial use of methylene chloride as a laboratory chemical is 
necessary to provide for the analysis of monitoring samples required to 
demonstrate compliance with the WCPP under this proposed regulation.
    An additional candidate for the WCPP is paint and coating removal 
from safety-critical, corrosion-sensitive components on military and 
Federal aviation. Regarding military aviation, as part of interagency 
collaboration with the DOD on the NPRM issued in January 2017 (Ref. 
47), EPA was made aware that there are specific military uses for which 
methylene chloride is essential for paint and coating removal for which 
there are no suitable alternatives currently available (see further 
discussion in Unit V.B.). These consist of the use of methylene 
chloride for the removal of coatings from corrosion-sensitive 
components on military aviation, including safety-critical components 
made of specialty metallic, nonmetallic, and composite materials. More 
specifically, this includes components such as landing gear, gear 
boxes, turbine engine parts, and other military aircraft components 
composed of metallic materials (specifically high-strength steel, 
aluminum, titanium, and magnesium) and composite materials that require 
their coatings be removed for inspection and maintenance. Similarly, as 
stated by commenters on EPA's 2017 NPRM (Ref. 38), aircraft and other 
assets operated by DHS, NASA, and the FAA also contain safety-critical, 
corrosion-sensitive components of the type described by DOD, and 
suitable alternatives to methylene chloride are similarly not available 
for all applications.
    As described further in Unit V.B., EPA concluded that under TSCA 
section 6(c)(2)(C) that technologically and economically feasible 
alternatives that benefit health or the environment would not be 
readily available as a substitute for these specific safety-critical 
uses on corrosion-sensitive components. However, under TSCA section 
6(a), EPA must still address identified risks such that they are no 
longer unreasonable. EPA considered the appropriateness of the WCPP for 
this subset of activities under industrial or commercial use of 
methylene chloride for commercial paint and coating removal, and 
emphasizes that this consideration was made very narrowly for the use 
of methylene chloride for paint and coating removal for safety-
critical, corrosion-sensitive components, and not for more general use 
of methylene chloride in paint and coating removal by Federal agencies 
or their contractors, or for aircraft or spacecraft paint and coating 
removal more broadly. Rather, EPA's consideration of the 
appropriateness of the WCPP takes into account the specifics of the 
components from which the coatings are being removed (and thus the lack 
of suitable alternatives for this particular subset of uses), and the 
relevant paint and coating removal processes. EPA notes that these 
activities are expected to take place in highly industrialized 
facilities in which regulated areas may already be established, for 
compliance with current regulations for methylene chloride or other 
chemicals, and that the paint and coating removal work in these 
facilities would not take place in small or enclosed spaces (rather, 
parts would frequently be removed for coating removal) (Ref. 48). 
Additionally, EPA considered whether exposures could feasibly be 
reduced sufficiently so that the risks were no longer unreasonable. To 
that end, during the risk evaluation for methylene chloride, DOD 
submitted additional monitoring data for their particular activities 
involving use of methylene chloride for paint and coating removal. 
EPA's risk evaluation shows that, in comparison with other uses of 
methylene chloride for paint and coating removal, the magnitude of 
exposure, and thus the risks, are much lower for DOD's specified use. 
More specifically, EPA's risk evaluation found that central tendency 
risks for DOD uses of methylene chloride for commercial

[[Page 28320]]

paint and coating removal do not exceed the acute or chronic non-cancer 
inhalation benchmarks, and high-end risks for those same endpoints 
could be addressed using the minimum allowable PPE for methylene 
chloride (Ref. 1). In addition to exposure reductions, EPA also 
considered whether other components of the WCPP could be effectively 
implemented, including development of exposure reduction plans, 
exposure monitoring, administrative controls, and workplace 
participation. During the development of this proposed rulemaking, 
discussions with DOD confirmed what was suggested by EPA's risk 
evaluation--that is, the remaining uses by DOD and other Federal 
agencies (e.g., DHS, NASA, and FAA) of methylene chloride for paint and 
coating removal for safety-critical, corrosion-sensitive components are 
highly industrialized and take place in controlled settings with 
numerous protections for workers already in place. In this way, use of 
methylene chloride for the removal of coatings from corrosion-sensitive 
components on military aviation, including safety-critical components 
made of specialty metallic, nonmetallic, and composite materials 
resembles other uses of methylene chloride for which the WCPP is being 
proposed, such as laboratory use. EPA further expects that Federal and 
Federal contractor facilities are subject to multiple levels of 
oversight as a result of the governmental and public nature of their 
activities, while civilian aviation facilities are not likely to 
experience the same level of scrutiny. Federal Government procurement 
is also subject to the Federal Acquisition Regulations System in Title 
49 of the CFR, which prescribes, among other things, health and 
environmental management and oversight requirements for Federal 
contracts. For this reason, EPA is proposing a WCPP for this particular 
subset of the methylene chloride commercial paint and coating remover 
condition of use. EPA requests comment and further information 
regarding the Agency's expectations that Federal and Federal contractor 
facilities would be subject to a higher level of oversight than non-
Federal or contractor facilities, and that existing or expected 
controls would be successful in achieving the requirements of the WCPP.
    Similarly, EPA has examined the use of methylene chloride as a 
bonding agent for acrylic and polycarbonate in mission-critical 
military and space vehicle applications by Federal agencies and their 
contractors (Ref. 43) and is proposing WCPP for this subset of the 
commercial use of methylene chloride in adhesives condition of use. 
Mission-critical applications potentially include fabrication of 
fixtures and enclosures for scientific research; production of 
optically clear articles such as space vehicle windows, space suit 
helmet components, or elements of extraterrestrial habitats; or sealing 
the plastic cases of specialty batteries.
    A stakeholder that produces lithium and silver oxide zinc batteries 
described how they are used in critical energy storage applications in 
military and space exploration settings, including defense applications 
such as precision guided weapons, military airframes, satellites, space 
launch vehicles, and spacecraft. (The stakeholder also described use of 
these batteries in medical devices; EPA notes that the TSCA definition 
of ``chemical substance'' excludes, under TSCA section 3(2)(B)(vi), 
``any food, food additive, drug, cosmetic, or device . . . when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.'' 15 U.S.C. 2602(2)(B)(vi). 
To the extent that bonding agents in the production of specialty 
batteries for medical applications qualify as a ``device'' as defined 
in section 201(h) of the Federal Food, Drug, and Cosmetic Act, those 
particular uses that qualify as a ``device'' would be excluded from the 
``chemical substance'' definition if ``manufactured, processed, or 
distributed in commerce for use as a . . . device,'' and would 
therefore not be subject to the rule if finalized). This stakeholder 
requested an exemption under TSCA section 6(g) for this use of 
methylene chloride. According to the requester, all major military and 
space applications, such as aircraft (F-35, B2), radios, and Mars 
mission equipment, require these batteries to function in very harsh 
conditions, including operation to -40 [deg]C and storage at -54 
[deg]C.
    Methylene chloride is used as a bonding agent for assembly of the 
plastic casings for these specialty batteries. The requester views the 
casing as a critical component of the battery because it houses and 
protects the cell anodes and cathodes. The requester explains that, 
during the solvent bonding process, methylene chloride dissolves the 
plastic slightly, allowing the polymers to form a physical bond 
comprised of the parent material. This results in a fully bonded 
battery casing which acts as a single Unit, rather than individual 
pieces integrated with layers of a different material. According to the 
requester, methylene chloride is a superior bonding agent for this 
process because of its unique evaporative qualities. In the requester's 
view, methylene chloride's low evaporation rate results in a higher 
degree of polymer bonding and a stronger casing, with less residue to 
inhibit the bonding process. The requester is not aware of any 
substance other than methylene chloride that would enable the 
production of battery casings of sufficient strength and durability for 
these specialty batteries. The requester further contends that the 
governmental and other entities for whom the requester produces these 
batteries prevent the substitution for methylene chloride in their 
contract specifications.
    EPA's consideration of the lack of availability of technologically 
and economically feasible alternatives, pursuant to TSCA section 
6(c)(2)(C), was one factor in the proposed determination not to 
prohibit manufacture, processing, distribution in commerce, and use of 
methylene chloride as a bonding agent for acrylic and polycarbonate in 
mission critical military and space vehicle applications, such as in 
the production of specialty batteries for use in such applications 
(Ref. 48) (discussed further in Unit V.B.). However, under TSCA section 
6(a), EPA must still address identified risks such that they are no 
longer unreasonable. Based on information provided by NASA and the 
vendor, EPA determined that the production of these specialty batteries 
necessarily occurs in a highly industrialized and well-controlled 
environment, which EPA does not expect to be replicated for most uses 
of methylene chloride in general use adhesives. Such a highly 
industrialized and well-controlled environment would allow for 
establishment of a regulated area and effective monitoring. 
Additionally, EPA expects that, for this specific use, facilities would 
be able to successfully implement the WCPP, including exposure 
reduction to levels below which the unreasonable risk would not be 
present due primarily to the small quantities of methylene chloride 
used, as well as to the engineering and other controls in place. For 
example, in the vendor's process, ``methylene chloride is a component 
of the bonding cement that is moved through an entirely closed tubing 
system into a vented reservoir and vented enclosure for bonding and 
curing'' (Ref. 48). In this way, use of methylene chloride as a bonding 
agent in specialty batteries resembles other uses of methylene chloride 
for which the WCPP is being proposed such as laboratory use and paint 
and coating

[[Page 28321]]

removal by Federal agencies on safety-critical, corrosion-sensitive 
aircraft components. For this reason, EPA is proposing a WCPP for this 
particular subset of the methylene chloride commercial use in adhesives 
condition of use. EPA requests comment and further information 
regarding the Agency's expectations that the facilities in which this 
use is carried out are industrialized and highly controlled, and that 
existing or expected exposure reduction and workplace controls would be 
successful in achieving the requirements of the WCPP. EPA also notes 
that while the Agency is not aware of any similar use of methylene 
chloride as a bonding element for batteries for commercial spaceflight 
or other use, it requests comment and information on any such use.
    For methylene chloride to be available for processing as a reactant 
and industrial and commercial use as a laboratory chemical, it must be 
manufactured (including imported), processed, and distributed in 
commerce. Likewise, as long as methylene chloride remains in use, it 
must also be disposed of. The manufacturing, processing, and disposal 
conditions of use for methylene chloride include, to some extent, the 
factors described earlier in this Unit favor the successful 
implementation of the WCPP (e.g., they do not take place in the field 
(i.e., they do not take place outside of a highly controlled 
environment) and are highly industrialized). Regulating upstream 
manufacturing and processing of methylene chloride is a key component 
of the supply-chain approach for risk management of commercial and 
consumer use of methylene chloride. Therefore, as discussed in Unit 
IV.A.1., EPA is proposing the WCPP for manufacture (including 
importing) and processing for certain uses, and disposal to ensure that 
workers are not subject to the unreasonable risk from methylene 
chloride as it moves throughout the supply chain.
    Additionally, for methylene chloride, the strong precedent for 
dermal protection set by 29 CFR 1910.1052, in combination with the risk 
characterization in the 2020 Risk Evaluation for Methylene Chloride 
which indicated chemically resistant gloves, together with activity 
specific training are sufficient to address the unreasonable risk, led 
EPA to propose a dermal PPE requirement as part of the WCPP (Ref. 1).
    As discussed in the Economic Analysis, there is some uncertainty 
relative to the burden of recycling and disposal facilities that would 
be required to implement a WCPP under this proposed regulation, 
particularly in implementing an air monitoring program. For example, 
disposal facilities may be receiving methylene chloride intermittently; 
however, facilities that currently receive methylene chloride-
containing products or formulations for disposal may not receive 
methylene chloride in the future, as restrictions are finalized. As 
many of these facilities are small entities, EPA is requesting comment 
on what regulatory flexibilities (e.g., extended compliance) may be 
afforded to entities that would continue to recycle and dispose of 
methylene chloride under the proposed regulation.
2. Prohibition
    Because both EPA's 8-hour ECEL and 15-minute EPA STEL are 
significantly lower than the OSHA PEL and STEL, there is a high degree 
of uncertainty as to whether most industrial and commercial users will 
be able to comply with such a level and thus whether the unreasonable 
risk would be addressed. As discussed earlier in this Unit, this 
uncertainty, combined with the severity of the risks of methylene 
chloride and the prevalence of cost-effective alternative processes and 
products (Ref. 3), has led EPA to propose prohibitions, rather than 
compliance with the WCPP, for most industrial and commercial uses of 
methylene chloride, as outlined in Unit IV.A.2.
    EPA also considered the potential for methylene chloride use to 
increase in particular sectors, such as vapor degreasing applications, 
where it has largely been phased out because of the well-established 
hazard (Refs. 3, 49). In order to prevent the potential for use of 
methylene chloride to increase in a sector that has already moved away 
from it, use of methylene chloride in vapor degreasing would be 
prohibited under the proposed regulatory and primary alternative 
regulatory action. The decline in use of methylene chloride was one of 
several considerations that led EPA to propose to prohibit use of 
methylene chloride in vapor degreasing.
    Regarding industrial, commercial, and consumer uses of methylene 
chloride, TSCA section 6(a)(2) provides EPA with the authority to 
prohibit or otherwise restrict the manufacture (including import), 
processing, or distribution in commerce of a substance or mixture ``for 
a particular use'' to ensure that a chemical substance no longer 
presents unreasonable risk. For this rule, EPA proposes that ``for a 
particular use'' includes consumer use more broadly, as well as 
industrial and commercial use, which encompasses the individual 
industrial, commercial, and consumer uses evaluated in the 2020 Risk 
Evaluation for Methylene Chloride. Given the severity and ubiquitous 
nature of the risks identified in the 2020 Risk Evaluation for 
Methylene Chloride for all industrial, commercial, and consumer use, 
and noting that those conditions of use encompass all known, intended, 
and reasonably foreseen use of methylene chloride (other than use of 
methylene chloride in consumer paint and coating removers, which was 
subject to separate action under TSCA section 6 (84 FR 11420, March 27, 
2019)), EPA proposes that prohibiting manufacture (including 
importing), processing, and distribution in commerce of methylene 
chloride for most industrial and commercial use and all consumer use is 
reasonable and necessary to eliminate the unreasonable risk of 
methylene chloride from industrial, commercial, and consumer use, 
including by precluding retailers from selling methylene chloride and 
methylene chloride-containing products to consumers for unspecified 
end-uses. (The proposed prohibitions would not extend to the use of 
methylene chloride in consumer paint and coating removers since 
manufacturing, processing, and distribution for that use are already 
prohibited.) EPA believes that any retailer selling methylene chloride-
containing products to consumers for unspecified end-uses would be 
selling products for use by consumers for one of the consumer uses EPA 
evaluated in the 2020 Risk Evaluation for Methylene Chloride and found 
to drive the unreasonable risk for methylene chloride in the 2022 
revised risk determination. EPA's proposed requirements to address 
unreasonable risk to consumers and bystanders to consumer use are 
described in Unit IV.A.
    A key consideration regarding consumer uses is the role of 
retailers and other distributors. A retailer is defined in 40 CFR 
751.103 as any entity that makes available a chemical substance or 
mixture to consumer end users, including through e-commerce internet 
sales or distribution, and is not specific to retailers of methylene 
chloride. Previously, in the 2019 methylene chloride TSCA section 6(a) 
risk management rulemaking addressing consumer use of methylene 
chloride in paint and coating removal (Ref. 37), EPA prohibited (see 40 
CFR 751.105(c)) retailers from distributing in commerce paint and 
coating removers containing methylene chloride, as well as distribution 
to retailers under 40 CFR 751.105(b) (Ref. 37). To meet the same

[[Page 28322]]

goal of protecting consumers from accessing methylene chloride-
containing products that could pose unreasonable risk, for a broader 
range of consumer use, EPA considered using a similar provision to 
ensure that retailers will not be able to purchase methylene chloride 
for sale or distribution to consumers, or to make available to 
consumers products containing methylene chloride. This provision aims 
to help prevent the use of methylene chloride in non-industrial 
settings or for off-label uses by consumers. For these reasons, as 
described in Unit IV.A.3., EPA's proposal to address unreasonable risk 
from methylene chloride includes prohibition on the distribution in 
commerce of methylene chloride to and by retailers.
3. Primary Alternative Regulatory Option
    EPA acknowledges that for some of the occupational uses that it is 
proposing to prohibit, there may be some activities or facilities that 
could implement workplace protection requirements necessary to ensure 
that exposure remain below the ECEL and EPA STEL. In some cases, they 
may be able to undertake more extensive risk reduction measures than 
EPA currently anticipates. Therefore, for EPA's primary alternative 
regulatory action described in Unit IV.B., EPA is considering and 
requesting comment on a WCPP, including requirements to ensure 
exposures remain below an ECEL and EPA STEL, for some conditions of use 
of methylene chloride in addition to those conditions of use which are 
proposed to be subject to a WCPP under the proposed regulatory action 
(i.e., those additional uses listed in Unit IV.B.). This includes 
conditions of use that have not resulted in documented acute 
fatalities, where reasonably available information suggests minimal 
ongoing use, where reasonably available information suggests use of 
methylene chloride may increase if other solvents are significantly 
restricted for that use such as for other solvents undergoing risk 
evaluation under TSCA section 6(b), and where the regulated entities 
may have fewer challenges implementing requirements to meet an ECEL and 
EPA STEL because work activities may occur in sophisticated facilities 
or take place in a closed system. The additional conditions of use 
which would be subject to WCPP under the primary alternative regulatory 
action described in this notice meet all of these criteria. However, 
EPA was not able to identify reasonably available information such as 
monitoring data or detailed activity descriptions to indicate with 
certainty that relevant regulated entities for these conditions of use 
could sufficiently mitigate identified unreasonable risk through a 
WCPP. Due to this uncertainty, EPA is requesting comment on the ways in 
which methylene chloride may be used in the additional conditions of 
use that would be subject to a WCPP under the primary alternative 
regulatory action, and the degree to which users of methylene chloride 
in these sectors could successfully implement the WCPP, including 
requirements to meet an ECEL and EPA STEL, as described in Unit 
IV.A.1., for the conditions of use listed for the primary alternative 
regulatory action in Unit IV.B.
    Additionally, As discussed in Unit V.A.1. and 2., EPA acknowledges 
that for the occupational uses for which it is proposing the WCPP, 
there are varying degrees of uncertainty as to whether industrial and 
commercial owners and operators are able implement workplace protection 
requirements necessary to ensure that exposures remain below the ECEL 
and EPA STEL. For this reason, EPA's alternative regulatory action 
would prohibit two uses for which EPA is proposing the WCPP (industrial 
or commercial use for paint and coating removal from safety-critical, 
corrosion-sensitive components of aircraft and spacecraft by Federal 
agencies and their contractors; and industrial or commercial use as a 
bonding agent in the production of specialty batteries for military or 
space applications by Federal agencies and their contractors). Because 
of the importance of these uses for national security and critical 
infrastructure, EPA's alternative regulatory action would include a 
time-limited exemption under TSCA section 6(g) from the prohibition for 
these two uses, for a period of 10 years, during which time the 
regulated entity would comply with a WCPP to the extent practicable. 
The analyses for these exemptions are in Unit IV.B.
4. Risk Management Requirements Considered but Not Proposed
    Since it is unlikely that all facilities with occupational 
exposures to methylene chloride would be able to implement a WCPP, 
including requirements to meet an ECEL and EPA STEL, EPA also examined 
the extent to which a certification and limited access program 
restricting methylene chloride use to trained and licensed users could 
ensure that only certain workers employed by a facility would be able 
to purchase and subsequently use methylene chloride. Under a limited 
access program, entities would submit a self-certification to the 
distributor at the point of purchasing the products. The self-
certification could consist of a statement indicating that the facility 
is implementing a WCPP to control exposures to methylene chloride, as 
well as a connection between the purchaser and the facility (e.g., a 
current employee). As discussed earlier in this Unit, because of the 
severity of acute risks from methylene chloride which could potentially 
lead to fatalities, and the high potential for diversion of commercial 
products of methylene chloride for non-commercial use, EPA has 
significant concerns regarding the appropriateness of a certification 
and limited access program for methylene chloride. These concerns are 
supported by previous comments received as part of public comments on 
the Advance Notice of Proposed Rulemaking for Methylene Chloride 
Commercial Paint and Coating Removal: Training, Certification and 
Limited Access Program expressing unease in implementing a training, 
certification and limited access program for methylene chloride (Ref. 
50).
    Several commenters on the Advance Notice of Proposed Rulemaking for 
Methylene Chloride Commercial Paint and Coating Removal: Training, 
Certification and Limited Access Program identified what they believe 
would be insufficiencies in training, certification, and limited access 
to methylene chloride (Ref. 50). Commenters expressed concerns that 
this type of program would not provide enough safeguards and would not 
eliminate unreasonable risk to workers. Commenters were skeptical of a 
training program's efficacy noting that deaths related to methylene 
chloride exposure still occurred with workers who were trained and 
wearing PPE (Ref. 50).
    Several commenters believed that a training, certification, and 
limited access program would not be feasible. A commenter suggested 
that an effective training model to examine is the Alaska Hazardous 
Paint Certification program, which includes hands-on training and 
practice in local exhaust ventilation techniques and equipment and PPE 
gloves, clothing, and respirators. In the Alaskan program, a minimum of 
16 hours for initial training, with at least 6 hours of hands-on 
training as well as 8-hour refresher class every 3 years, are necessary 
requirements. Moreover, commenters expressed that a robust training, 
certification, and limited access program would include multiple layers 
of training and certification and supporting documentation. A commenter 
also highlighted that ``small businesses do not have the same resources 
for implementing safety

[[Page 28323]]

programs as larger ones, yet they account for a very large percentage 
of [methylene chloride] users.'' In light of these comments, EPA 
decided to account for uncertainty related to ECEL implementation and 
compliance for certain uses by proposing prohibitions on those uses, 
rather than proposing a self-certification and limited access program. 
Nonetheless, EPA is requesting comment on the inclusion of a 
certification, training, and limited access program for any uses that 
would be subject to a WCPP, in addition to the requirements outlined in 
Unit IV.A.1.
    Another option that EPA considered for occupational conditions of 
use was requiring specific, prescribed engineering controls, 
administrative controls, or PPE to reduce exposures to methylene 
chloride in occupational settings. These prescriptive requirements 
would be supported by information in the 2020 Risk Evaluation for 
Methylene Chloride. As described in Units III.A.1. and 2., EPA received 
input during required consultations and additional engagement that 
options that align with the hierarchy of controls (i.e., elimination 
and substitution of hazards in the workplace), which could be 
accomplished through the implementation of a WCPP with a risk-based 
exposure limit, should be preferred over prescriptive controls (Refs. 
9, 51). Inadequacy of engineering, administrative, and PPE control 
measures to lower exposure below the exposure limit would mean that 
elimination or substitution would be the only viable methods of 
addressing unreasonable risk, creating in effect a de-facto 
prohibition. Additionally, prescriptive controls present significant 
uncertainties related to their feasibility and consistency of proper 
use.
    EPA determined that such prescriptive controls (i.e., engineering 
or administrative controls, or PPE) may not be able to eliminate 
unreasonable risk for some conditions of use when used in isolation. In 
the 2020 Risk Evaluation for Methylene Chloride, many conditions of use 
still drive the unreasonable risk even with the application of air-
supplied APF 50 respirators (Ref. 1). Additionally, where data were 
reasonably available, EPA modeled the change in air rates that would be 
needed to eliminate unreasonable risk and found that in some cases it 
was not possible to eliminate unreasonable risk with changes in airflow 
alone, while in other cases the change in airflow needed would not be 
feasible to achieve (Ref. 1). Because of the uncertainty regarding the 
feasibility of exposure reductions through prescriptive controls alone, 
EPA determined that a WCPP, including requirements to meet an ECEL and 
EPA STEL (which would be accompanied by monitoring requirements) in 
tandem with the implementation of engineering controls, administrative 
controls, and/or PPE as elements of the program, as appropriate, would 
more successfully reduce exposure so that the unreasonable risk is 
addressed. For occupational conditions of use where compliance with the 
WCPP is unlikely to eliminate the unreasonable risk driven by those 
conditions of use, prohibitions (rather than prescribed controls) would 
be more appropriate to ensure that methylene chloride does not present 
unreasonable risk under the conditions of use.
    EPA also considered limiting the weight fraction of methylene 
chloride in consumer products and conducted an analysis using the 
Consumer Exposure Models for the 2020 Risk Evaluation for Methylene 
Chloride to estimate whether this would reduce risks from consumer 
conditions of use that drive the unreasonable risk for methylene 
chloride, such that they no longer drive the unreasonable risk (Ref. 
52). For all consumer conditions of use, the weight fraction or 
concentration identified through this modeling that would address the 
unreasonable risk through inhalation or dermal pathways was so low that 
it was highly unlikely that methylene chloride would still serve its 
functional purpose in the formulation. EPA thus concluded that a weight 
fraction limit would essentially function as a prohibition yet with a 
greater amount of uncertainty regarding compliance and no increased 
benefit to consumer users; it was therefore not a preferred option for 
consumer uses. (Refs. 1, 52).
5. Additional Considerations
    After considering the different regulatory options under TSCA 
section 6(a), alternatives (described in Unit III.B.4.), compliance 
dates, and other requirements under TSCA section 6(c), EPA developed 
the proposed regulatory action described in Unit IV.A. to address the 
unreasonable risk from methylene chloride. To ensure successful 
implementation of this proposed regulatory action, EPA considered other 
requirements to support compliance with the proposed regulations, such 
as requiring monitoring and recordkeeping to demonstrate compliance 
with the WCPP, or downstream notification regarding the prohibition on 
manufacturing, processing, and distribution in commerce of methylene 
chloride, and products containing methylene chloride, for consumer use. 
These proposed requirements are described in Unit IV.A.
    Under TSCA section 6(g)(1)(B), EPA may grant an exemption from a 
requirement of a TSCA section 6(a) rule for a specific condition of use 
of a chemical substance or mixture if compliance with the requirement 
would significantly disrupt the national economy, national security, or 
critical infrastructure. Based on reasonably available information, EPA 
has found that a TSCA section 6(g) exemption is warranted for certain 
uses. Therefore, EPA is proposing to grant exemptions from the rule 
requirements under TSCA section 6(g), as detailed in Unit IV.A.5. Unit 
IV.A.5. also provides a description of the request for exemption from 
the rule requirements that EPA is not proposing to grant. TSCA section 
6(g) assumes a particular use cannot continue such that the risks are 
no longer unreasonable. However, EPA notes that information may be 
provided during the public comment period indicating this may not be 
case. For example, new information may demonstrate compliance with a 
WCPP is possible.
    As required under TSCA section 6(d), any rule under TSCA section 
6(a) must specify mandatory compliance dates, which shall be as soon as 
practicable with a reasonable transition period, but no later than 5 
years after the date of promulgation of the final rule (except in the 
case of a use exempted under TSCA section 6(g)). For ban or phase-out 
requirements, EPA must specify mandatory compliance dates for the start 
of ban or phase-out requirements, which must be as soon as practicable 
but no later than 5 years after the date of promulgation of the final 
rule (except in the case of a use exempted under TSCA section 6(g)), 
and for full implementation of ban or phase-out requirements, which 
must be as soon as practicable. These compliance dates are detailed in 
Unit IV.A. and IV.B.

B. Consideration of Alternatives in Deciding Whether To Prohibit or 
Substantially Restrict Methylene Chloride

    Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or 
restrict in a manner that substantially prevents a specific condition 
of use of a chemical substance or mixture, and in setting an 
appropriate transition period for such action, EPA must consider, to 
the extent practicable, whether technically and economically feasible 
alternatives that benefit human health or the environment, compared to 
the use so proposed to be prohibited or restricted,

[[Page 28324]]

will be reasonably available as a substitute when the proposed 
prohibition or other restriction takes effect. To that end, in addition 
to an Economic Analysis (Ref. 3), EPA conducted an Alternatives 
Assessment, using reasonably available information (Ref. 40).
    For this assessment, EPA identified and analyzed alternatives to 
methylene chloride in products relevant to industrial, commercial, and 
consumer conditions of use proposed to be prohibited or restricted, 
even if such restrictions are not anticipated to substantially prevent 
the condition of use. EPA is aware of the lack of viable alternatives 
to methylene chloride for several conditions of use and considered that 
information to the extent practicable in the development of the 
regulatory options as described in Unit III.B.3.
    As an example, EPA's consideration of the lack of viable 
alternatives to processing methylene chloride in the manufacture of 
HFC-32 taken in context with the risk estimates, monitoring data, and 
expected work practices informed EPA's proposed approach of WCPP for 
this condition of use. Similarly, when proposing WCPP for industrial or 
commercial use of methylene chloride for paint and coating removal from 
mission- and safety-critical, corrosion sensitive components of 
aircraft and spacecraft by Federal agencies or their contractors, EPA 
considered how the safety-critical, corrosion-sensitive components 
would be so negatively affected by the use of technically incompatible, 
substitute paint removal chemicals or methods that the safe performance 
of the aircraft could be compromised. There are no known substitutes 
for methylene chloride for this particular use. As discussed in the 
preamble to the 2017 NPRM, DOD has actively sought to reduce its use of 
methylene chloride in paint and coating removal since 1990. DOD has 
replaced most of its usage of methylene chloride for paint and coating 
removal with mechanical methods, benzyl alcohol products, other 
solvents, and laser ablation. In an effort to reduce the use of all 
hazardous air pollutants (HAPs) such as methylene chloride, the Army 
has conducted tests to identify and test the effectiveness of HAP-free 
paint and coating removers on military high-performance coatings (Ref. 
53). In another example, the Air Force in December 2015 significantly 
reduced the use of methylene chloride for removing coatings on flight 
control parts and is now using substitute chemical products, primarily 
those with benzyl alcohol formulations (Ref. 48). Similarly, the Navy 
has transitioned substitutes to paint methylene chloride use when 
alternatives with equal performance are identified. For DOD, this 
evaluation of and transition to safer alternatives is ongoing and 
substitutions are approved where technically feasible and commensurate 
with performance and mission-readiness requirements.
    DOD continues to pursue potential substitutes for methylene 
chloride. However, for safety-critical, corrosion-sensitive components 
on military aviation, including safety-critical components, DOD has 
found that currently available substitute chemicals for paint and 
coating removal have one or more technical limitations. These include 
the inability to effectively remove specific military high performance 
or chemical resistant coatings and incompatibility with underlying 
metallic, nonmetallic, and composite materials, resulting in material 
damage to critical components. In addition, substitute chemicals or 
methods currently available do not support DOD's need for coating 
removers that enable critical safety inspection, non-destructive 
inspection, material assessment, or field repair processes. For 
example, benzyl alcohol has replaced methylene chloride in many DOD 
paint and coating removal applications. However, acid benzyl alcohol 
formulations, which work more quickly than alkaline formulations, 
cannot be used on high-strength steel or magnesium metals because there 
is the potential for resulting hydrogen embrittlement (Ref. 54). In 
DOD's experience, the alkaline benzyl alcohol formulations require 25 
to 50% more time than methylene chloride and are more labor-intensive, 
particularly on very thick coatings or polyurethane coatings with 
water-based primers (Ref. 54). In addition, the reaction rate for 
alkaline benzyl alcohol formulations is very slow when the temperature 
is below 65 degrees, so paint and coating removal in cold locations 
with this alternative must be performed in a heated area (Ref. 54). As 
described earlier in Unit V.A.1., aircraft and other assets operated by 
DHS, NASA, and the FAA also contain safety-critical, corrosion-
sensitive components of the type described by DOD, and suitable 
alternatives to methylene chloride are similarly not available for all 
applications. Substitute chemicals for paint and coating removal for 
safety-critical, corrosion-sensitive components are not technically 
feasible as they have one or more technical limitations; are 
incompatible with underlying materials; and/or do not support the 
coating removal requirements of safety inspections, non-destructive 
inspection, material assessment, or field repair processes. Therefore, 
EPA has evaluated the effect that a significant restriction on the use 
of methylene chloride would have for industrial and commercial paint 
and coating removal by DOD, DHS, NASA, and FAA and concluded that under 
TSCA section 6(c)(2)(C) that technologically and economically feasible 
alternatives that benefit health or the environment would not be 
readily available as a substitute. Due to the essential nature of this 
subset of activities under industrial or commercial use of methylene 
chloride as a paint and coating remover, EPA's consideration of the 
availability of technologically and economically feasible alternative 
was one factor in the proposed determination not to prohibit 
manufacture, processing, distribution in commerce, and use of methylene 
chloride for paint and coating removal for safety-critical, corrosion 
sensitive components.
    As an additional example, EPA considered the information provided 
regarding a lack of viable alternatives for the use of methylene 
chloride in chemical bonding of acrylic and polycarbonate, specifically 
for specialty batteries for use in military and space applications. As 
described earlier in Unit V.A., EPA received information from a 
stakeholder, as part of a request for an exemption under TSCA section 
6(g), describing how methylene chloride is uniquely suited as a bonding 
agent for these specialty batteries. Upon receipt of the TSCA section 
6(g) exemption request summarized in this unit, EPA consulted with 
NASA, and NASA provided information on its effort to screen alternative 
adhesives for the chemical bonding of acrylic and polycarbonate. 
Specifically, NASA identified ten materials and completed screening-
level testing for six of those ten materials as of the publication of 
this proposed rule. Results submitted to EPA indicate that none of the 
materials tested met the technical requirements for chemical bonding 
applications (Ref. 47). While vendors submitting the TSCA section 6(g) 
exemption request predicted a timeline of at least one year to find a 
replacement for the bonding agent for specialty batteries, NASA noted 
that the projected substitution timeline applies only to the vendor's 
own battery production process. The total timeline, including 
qualification testing for human spaceflight, is a complex, multi-year 
process that could only begin after the vendor's substitution was 
completed.

[[Page 28325]]

    NASA additionally emphasized that losing access to qualified high-
performance substances such as specialty batteries would have immediate 
effects for currently ongoing space-flight programs, including the 
Artemis Program, with the potential to introduce an unacceptable level 
of risk to crew, vehicle, and viability of the program. Qualification 
of materials for human spaceflight can take years and significant 
resources to accomplish, while potentially impacting program production 
schedule and launch manifest.
    NASA has emphasized that specific Artemis components have been 
designed to work with the identified specialty batteries with 
polycarbonate casing bonded using methylene chloride. The safety and 
reliability of these batteries has been established in uncrewed Artemis 
I test missions, and the next flights will take humans back to the 
Moon. A change of battery material would require recertification of 
multiple hardware pieces, retesting of crew and vehicle safety, and 
disrupt parts production and launch schedules that are already 
underway. NASA notes that stockpiling of batteries would not be an 
option, as batteries have a 2-year shelf life.
    For this use, EPA has concluded under TSCA section 6(c)(2)(C) that 
technologically and economically feasible alternatives that benefit 
health or the environment would not be readily available as a 
substitute. Due to the essential nature of this subset of activities 
under industrial or commercial use of methylene chloride as an 
adhesive, a paint and coating remover, EPA's consideration of the 
availability of technologically and economically feasible alternative 
was one factor in the proposed determination not to prohibit 
manufacture, processing, distribution in commerce, and use of methylene 
chloride as a bonding agent in the production of specialty batteries 
for use in military and space applications.
    EPA also notes that, for some conditions of use, EPA was unable to 
identify products currently available for sale that contain methylene 
chloride. EPA is soliciting comments on whether there are actually 
products in use or available for sale relevant to these conditions of 
use that contain methylene chloride at this time, so that EPA can 
ascertain whether there are alternatives that benefit human health or 
the environment. These conditions of use are detailed in the 
Alternatives Assessment (Ref. 40).
    For conditions of use for which products currently containing 
methylene chloride were identified, EPA identified several hundred 
commercially available alternative products that do not contain 
methylene chloride, and listed in the Alternatives Assessment, to the 
extent practicable, their unique chemical components, or ingredients. 
For each of these chemical components or ingredients, EPA identified 
whether it functionally replaced methylene chloride for the product use 
and screened product ingredients for human health and environmental 
hazard, as well as identified flammability and global warming potential 
where information was reasonably available (Ref. 40). EPA then assigned 
a rating to the human health and environmental hazards, using a 
methodology described in the Alternatives Assessment document. EPA 
identified 65 total alternative products in the paint and coating 
remover category, of which furniture refinishing is a subcategory (Ref. 
48). As described in the Economic Analysis, while not all of these 
alternative products may meet the specific use for some furniture 
refinishing uses, mechanical or thermal methods may be non-chemical 
alternatives to using products containing methylene chloride for paint 
and coating removal. EPA did not find barriers to pricing, customer 
satisfaction, coating removal performance, or content (specifically 
volatile organic compounds, or VOC) that may be caused by restricting 
the use of methylene chloride in this product category in general. For 
fire safety, the restriction of methylene chloride in this product 
category is met by products with very high flash points, or products 
with evaporation barriers that restrict vapor generation (Ref. 3). 
Therefore, EPA finds that there are technological and economically 
feasible alternatives in the marketplace.
    In general, EPA identified products containing ingredients with a 
lower hazard screening rating than methylene chloride for certain 
endpoints, while some ingredients presented higher hazard screening 
ratings than methylene chloride (Ref. 40). These alternative hazard 
screening ratings are described in detail in the Alternatives 
Assessment grouped under common product use categories (Ref. 40). EPA 
has therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the 
extent practicable, whether technically and economically feasible 
alternatives that benefit human health or the environment, compared to 
the use proposed to be prohibited or restricted, will be reasonably 
available as a substitute when the proposed prohibition or other 
restriction becomes effective. EPA is additionally requesting comment 
on the alternatives analysis as a whole.

VI. TSCA Section 6(c)(2) Considerations

A. Health Effects of Methylene Chloride and the Magnitude of Human 
Exposure to Methylene Chloride

    EPA's analysis of the health effects of methylene chloride is in 
the 2020 Risk Evaluation for Methylene Chloride (Ref. 1). A summary is 
presented here.
    The 2020 Risk Evaluation for Methylene Chloride identified six non-
cancer adverse health effects: effects from acute/short-term exposure, 
liver effects, immune system effects, nervous system effects, 
reproductive/developmental effects, and irritation/burns (Ref. 1). The 
2020 Risk Evaluation for Methylene Chloride also identified cancer 
hazards from carcinogenicity as well as genotoxicity, particularly for 
liver and lung tumors (Ref. 1).
    Among the non-cancer adverse health effects, the 2020 Risk 
Evaluation for Methylene Chloride identified neurotoxicity indicative 
of central nervous system depression as a primary effect of methylene 
chloride in humans following acute inhalation exposures (Ref. 1). 
Identified central nervous system depressive symptoms include 
drowsiness, confusion, headache, dizziness, and neurobehavioral 
deficits when performing various tasks. Central nervous system 
depressant effects can result in loss of consciousness and respiratory 
depression, possibly resulting in irreversible coma, hypoxia, and 
eventual death (Ref. 1).
    Additionally, the 2020 Risk Evaluation for Methylene Chloride 
identified the liver as a sensitive target organ for inhalation 
exposure (Ref. 1). For human health risks to workers and consumers, EPA 
identified cancer and non-cancer human health risks. Risks from acute 
exposures include central nervous system risks such as central nervous 
system depression and a decrease in peripheral vision, each of which 
can lead to workplace accidents and are precursors to more severe 
central nervous system effects such as incapacitation, loss of 
consciousness, coma, and death. For chronic exposures, EPA identified 
risks of non-cancer liver effects as well as liver and lung tumors 
(Ref. 1).
    The 2020 Risk Evaluation for Methylene Chloride also identified 
several irritation hazards from methylene chloride exposure. Following 
exposures to methylene chloride vapors, irritation has been observed in 
the respiratory tract and eyes. Direct contact with liquid methylene 
chloride on the

[[Page 28326]]

skin has caused chemical burns in workers and gastrointestinal 
irritation in individuals who accidentally ingested methylene chloride 
(Ref. 1).
    Regarding the magnitude of human exposure, one factor EPA considers 
for the conditions of use that drive unreasonable risk is the size of 
the exposed population, which, for methylene chloride, EPA estimates is 
785,000 workers, 135,000 occupational non-users, and 15 million 
consumers (Ref. 1).
    In addition to these estimates of numbers of workers, occupational 
non-users, consumers, and bystanders to consumer use directly exposed 
to methylene chloride, EPA recognizes there is exposure to the general 
population from air and water pathways for methylene chloride. (While 
bystanders are individuals in proximity to a consumer use of methylene 
chloride, fenceline communities are a subset of the general population 
who may be living in proximity to a facility where methylene chloride 
is being used in an occupational setting). As mentioned in Unit II.D., 
EPA has separately conducted a screening approach to assess whether 
there may be risks to the general population from these exposure 
pathways. While the use of this screening approach indicates some level 
of risk to fenceline communities, EPA cannot determine, without further 
data and quantitative analysis, whether the risk to these communities 
would be an unreasonable risk. This Unit summarizes the results of that 
fenceline analysis. Although EPA is not making a determination of 
unreasonable risk based on the fenceline screening analysis, the 
proposed regulatory action described in Unit IV. is expected to reduce 
the risks identified in the screening approach.
    As described in Unit II.D., EPA's analysis was presented to the 
SACC peer review panel in March 2022, and EPA plans to consider SACC 
feedback (including the SACC recommendation to EPA to consider multiple 
years of release data to estimate exposures and associated risks) and 
make decisions regarding how to assess general population exposures in 
upcoming risk evaluations, such as for 1,4-dioxane and for the 
forthcoming 20 High Priority Substances. For methylene chloride, EPA 
recognizes that a key input into the fenceline assessment was data on 
releases from the most recent Toxics Release Inventory (TRI) reporting 
year and that the use of more than one year of data could result in 
different conclusions. Accordingly, in this Unit EPA presents the 
results of its analysis of the extent to which including more than one 
year of TRI data impacts EPA's conclusions regarding fenceline risks 
(Ref. 55).
    EPA's fenceline analysis for the water pathway for methylene 
chloride, based on methods presented to the SACC, did not find risks 
from incidental oral and dermal exposure to surface water, and while 
EPA found one facility which indicated acute risk from drinking water, 
additional assessment of this location identified that there are no 
source drinking water intakes for public drinking water systems in 
proximity to the facility estimated to have risk, thereby making risks 
to the general population through the drinking water pathway unlikely.
    Additionally, EPA's analysis, as presented to the SACC, identified 
14 facilities, representing nine conditions of use, with some 
indication of expected exposure and associated cancer risk to receptors 
within select distances evaluated from 5 to 100 meters from the 
inhalation pathway. Those nine conditions of use are: industrial and 
commercial use in non-aerosol degreasers and cleaners; industrial and 
commercial use as a solvent for in-line vapor degreasing; industrial 
and commercial use as a solvent for cold cleaning; industrial and 
commercial use in aerosol spray degreasers and cleaners; industrial and 
commercial use in cellulose triacetate film production; industrial and 
commercial use in plastic and rubber product manufacturing; processing: 
incorporation into a formulation, mixture, or reaction product; 
industrial and commercial use as a propellant and blowing agent; and 
industrial and commercial use in paint and coating removers. Under the 
proposed regulatory action described in Unit IV.A., all of the 
conditions of use with an indication of risk from 5 to 100 meters would 
be prohibited, with the exception of processing: incorporation into a 
formulation, mixture, or reaction product.
    Of those 14 facilities with indicated risk, only three had an 
indication of risk out to 100 meters from a releasing facility. Those 
three facilities represent three total conditions of use: industrial 
and commercial use in non-aerosol degreasers and cleaners; industrial 
and commercial use for plastic product manufacturing; and industrial 
and commercial use as a propellant and blowing agent. Under the 
proposed regulatory action described in Unit IV.A., these three 
conditions of use, as well as all of the conditions of use with an 
indication of risk at 5 to 100 meters would be prohibited, with the 
exception of processing: incorporation into a formulation, mixture, or 
reaction product.
    Following SACC feedback, EPA applied a slightly modified pre-
screening methodology to evaluate 6 years of methylene chloride release 
data (2015 through 2020 Toxic Release Inventory data as well as the 6-
year average of that data) for those 14 facilities where there was an 
indication of exposure and associated risk via the ambient air pathway. 
The multi-year analysis further supported EPA's findings (indications 
of exposure and associated risks) from the original analysis for five 
of the 14 facilities, representing four conditions of use, which 
indicated exposure and associated risk at 100 meters from a releasing 
facility. Those four conditions of use are: processing: incorporation 
into a formulation, mixture, or reaction product; industrial and 
commercial use in non-aerosol degreasers and cleaners; industrial and 
commercial use for plastic product manufacturing; and industrial and 
commercial use as a propellant and blowing agent. For the additional 
nine facilities, the multi-year analysis did not indicate risks at 100 
meters. The multi-year analysis incorporated 6 years of TRI data and 
found that while the annual releases may vary by as much as a factor of 
10, the overall estimated exposure concentrations and associated risk 
calculations varied by no more than three times. Additionally, typical 
cancer benchmarks used by EPA and other regulatory agencies are an 
increased cancer risk above benchmarks ranging from 1 in 1,000,000 to 1 
in 10,000 (i.e., 1 x 10-6 to 1 x 10-4), in some 
cases depending on the subpopulation exposed. (see, e.g., EPA's 
interpretation set forth in 54 FR 38044, September 14, 1989) which 
discusses the use of benchmarks for purposes of section 112 of the 
Clean Air Act (CAA); see also EPA's interpretation of the upper bound 
of acceptable risk and the preferred benchmark described in the Letter 
of Concern regarding EPA Complaint Nos. 01R-22-R6, 02R-22-R6, and 04R-
22-R6 see page 3 footnotes 5 and 6 and page 6 (Ref. 56)). In this 
fenceline analysis for the ambient air pathway for methylene chloride, 
estimates of risk to fenceline communities were calculated using 1 x 
10-6 as the benchmark for cancer risk in fenceline 
communities. While EPA is unable to determine, based on the screening 
level fenceline analysis, whether risks to the general population drive 
the unreasonable risk, as a matter of risk management policy EPA 
considers the range of 1 x 10-6 to 1 x 10-4 as 
the appropriate benchmark

[[Page 28327]]

for increased cancer risk for the general population, including 
fenceline communities. It is preferable to have the air concentration 
of methylene chloride result in an increased cancer risk closer to the 
1 x 10-6 benchmark, with the 1 x 10-4 benchmark 
generally representing the upper bound of acceptability for estimated 
excess cancer risk. The benchmark value is not a bright line, and the 
Agency considers a number of factors when determining unreasonable 
risk, such as the endpoint under consideration, the reversibility of 
effect, exposure-related considerations (e.g., duration, magnitude, or 
frequency of exposure, or population exposed). Under the proposed 
regulatory action described in Unit IV.A., all of the conditions of use 
with an indication of risk at 100 meters would be prohibited, with the 
exception of processing: incorporation into a formulation, mixture, or 
reaction product.
    Although the initial analysis presented to SACC and the multi-year 
analysis conducted in response to SACC feedback for methylene chloride 
indicated exposure and associated risks to select receptors within the 
general population at particular facilities, EPA is unable to formally 
determine with this analysis whether those risks drive the unreasonable 
risk. However, EPA believes that the prohibitions being proposed for 
manufacturing (including importing), processing, and distribution in 
commerce for 45 of 53 uses, including all consumer use and most 
commercial use, would address the majority of exposures to the general 
population. Of the 14 facilities which indicated some risk for 
methylene chloride, under the proposed regulatory option, only 3 could 
continue to use methylene chloride (all for processing: incorporation 
into formulation, mixture, or reaction product), and thus exposures to 
the fenceline at the remainder of those facilities would be addressed.
    Under the proposed rule, only ten conditions of use would continue, 
namely domestic manufacturing (for downstream uses that would continue 
under the WCPP); import; processing as a reactant; processing: 
incorporation into a formulation, mixture, or reaction product; 
processing as repackaging; processing as recycling; industrial and 
commercial use as a laboratory chemical; industrial or commercial use 
in aerospace and military paint and coating removal from safety-
critical, corrosion-sensitive components by Federal agencies and their 
contractors, industrial or commercial use as a bonding agent for 
acrylic and polycarbonate in mission-critical military and space 
vehicle applications, including in the production of specialty 
batteries for such by Federal agencies and their contractors, and 
disposal. Of those conditions of use, only processing: incorporation 
into formulation, mixture, or reaction product has risk indicated at 
the fenceline, and based on land use analysis, there do not appear to 
be communities currently located at the fencelines (Ref. 57). 
Additionally, over time this condition of use can reasonably be 
expected to decline because, while processing into a formulation, 
mixture, or reaction product would continue under a WCPP, all 
downstream distribution and use of formulations, mixtures, or reaction 
products (except for laboratory use and any time limited exemptions 
that could be established under TSCA section 6(g)) would be prohibited.
    For all ten conditions of use that would remain ongoing, the 
proposed rule would require exposure controls via implementation of a 
WCPP as described in Unit IV.A.1. In the instances where efforts to 
reduce exposures in the workplace to levels below the ECEL and EPA STEL 
could lead to adoption of engineering controls that ventilate more 
methylene chloride outside, EPA believes this potential exposure would 
be limited as a result of the existing National Emission Standards for 
Hazardous Air Pollutants (NESHAPs) for methylene chloride for these 
conditions of use under the CAA (applicable NESHAPs: 40 CFR part 63 
subpart F, Synthetic Organic Chemical Manufacturing Industry; 40 CFR 
part 63 subpart DD, Off-Site Waste and Recovery Operations; 40 CFR part 
63 subpart VVV, Publicly Owned Treatment Works; and 40 CFR part 63 
subpart VVVVVV, the NESHAP for Chemical Manufacturing Area Sources) and 
that any exceedances are an enforcement issue. Thus, EPA's proposal to 
prohibit manufacture, processing, and distribution in commerce of 
methylene chloride for all consumer use and most industrial and 
commercial use, and to prohibit most industrial and commercial use of 
methylene chloride, is expected to largely address the risks identified 
in the screening analysis to any general population or fenceline 
communities close to facilities engaging in methylene chloride use. EPA 
therefore does not intend to revisit the air pathway for methylene 
chloride as part of a supplemental risk evaluation.

B. Environmental Effects of Methylene Chloride and the Magnitude of 
Environmental Exposure to Methylene Chloride

    EPA's analysis of the environmental effects of and the magnitude of 
exposure of the environment to methylene chloride is in the 2020 Risk 
Evaluation for Methylene Chloride (Ref. 1). The unreasonable risk 
determination for methylene chloride is based solely on risks to human 
health; based on the 2020 Risk Evaluation for Methylene Chloride, EPA 
determined that exposures to the environment did not drive the 
unreasonable risk.
    For all conditions of use, the unreasonable risk determination is 
not driven by exposures via water for acute and chronic exposures to 
methylene chloride for amphibians, fish, and aquatic invertebrates. To 
characterize aquatic organisms' exposure to methylene chloride, modeled 
data were used to represent surface water concentrations near 
facilities actively releasing methylene chloride to surface water, and 
monitored concentrations were used to represent ambient water 
concentrations of methylene chloride. EPA considered the biological 
relevance of the species to determine the concentrations of concern for 
the location of surface water concentration data to produce risk 
quotients, as well as frequency and duration of the exposure. While 
some site-specific risk quotients, calculated from modeled release data 
from facilities conducting recycling, disposal, and wastewater 
treatment plant activities, indicated risk, uncertainties in the 
analysis were considered. These uncertainties include limitations in 
data, since monitoring data were not available near facilities where 
methylene chloride is released, and data incorporated from the Toxics 
Release Inventory, which does not include release data for facilities 
with fewer than ten employees. As an additional uncertainty, the model 
does not consider chemical fate or hydrologic transport properties and 
may not consider dilution in static water bodies. Additional analysis 
indicated that model outputs, rather than monitoring estimates, may 
best represent concentrations found at the point of discharge from the 
facilities (Ref. 1).
    The toxicity of methylene chloride to sediment-dwelling 
invertebrates is similar to its toxicity to aquatic invertebrates. 
Methylene chloride is most likely present in the pore waters and not 
absorbed to the sediment organic matter because methylene chloride has 
low partitioning to organic matter. The concentrations in sediment

[[Page 28328]]

pore water are similar to or less than the concentrations in the 
overlying water, and concentrations in the deeper part of sediment are 
lower than the concentrations in the overlying water. Therefore, the 
risk estimates, based on the highest ambient surface water 
concentration, do not support an unreasonable risk determination to 
sediment-dwelling organisms from acute or chronic exposures. There is 
uncertainty due to the lack of ecotoxicity studies specifically for 
sediment-dwelling organisms and limited sediment monitoring data (Ref. 
1).
    Based on its physical-chemical properties, methylene chloride does 
not partition to or accumulate in soil. Therefore, the physical 
chemical properties of methylene chloride do not support an 
unreasonable risk determination to terrestrial organisms.

C. Benefits of Methylene Chloride for Various Uses

    Methylene chloride is a solvent used in a variety of industrial, 
commercial, and consumer use applications, including adhesives, 
pharmaceuticals, metal cleaning, chemical processing, and feedstock in 
the production of refrigerant hydrofluorocarbon-32 (HFC-32) (82 FR 
7467). Specifically, methylene chloride use in commercial paint and 
coating removal provides benefits for some users because it is readily 
available and works quickly and effectively on nearly all coatings 
without damaging most substrates. For a variety of additional uses 
(e.g., adhesives, adhesive removers, cold pipe insulation, welding 
anti-spatter spray) methylene chloride is relatively inexpensive, 
highly effective, evaporates quickly, and is not flammable, making it a 
popular and effective solvent for many years. As of 2016, the leading 
applications for methylene chloride are as a solvent in the production 
of pharmaceuticals and polymers and paint removers, although recent 
regulations and voluntary industry actions are expected to decrease the 
chemical's use in the paint remover sector (40 CFR part 751, subpart 
B). The total aggregate production volume ranged from 100 to 500 
million pounds between 2016 and 2019 according to CDR (Ref. 8).

D. Reasonably Ascertainable Economic Consequences of the Proposed Rule

1. Likely Effect of the Rule on the National Economy, Small Business, 
Technological Innovation, the Environment, and Public Health.
    The reasonably ascertainable economic consequences of this proposed 
rule include several components, all of which are described in the 
Economic Analysis for this proposed rule (Ref. 3). With respect to the 
anticipated effects of this proposed rule on the national economy, EPA 
considered the number of businesses and workers that would be affected 
and the costs and benefits to those businesses and workers and did not 
find that there would be an impact on the national economy (Ref. 3). 
The economic impact of a regulation on the national economy becomes 
measurable only if the economic impact of the regulation reaches 0.25% 
to 0.5% of Gross Domestic Product (GDP) (Ref. 58). Given the current 
GDP, this is equivalent to a cost of $40 billion to $80 billion. 
Therefore, because EPA has estimated that the non-closure-related cost 
of the proposed rule would range from $13.2 million annualized over 20 
years at a 3% discount rate and $14.5 million annualized over 20 years 
at a 7% discount rate, EPA has concluded that this rule is highly 
unlikely to have any measurable effect on the national economy (Ref. 
3). In addition, EPA considered the employment impacts of this proposed 
rule, and found that the direction of change in employment is 
uncertain, but EPA expects the short-term and longer-term employment 
effects to be small. To that end, EPA is requesting public comment on 
short term and longer-term employment effects from this proposal.
    Of the small businesses potentially impacted by this proposed rule, 
98% (225,248 firms) are expected to have impacts of less than 1% to 
their firm revenues (rounded metric), 0.1% (118 firms) are expected to 
have impacts between 1 and 3% to their firm revenues (rounded metric), 
and 0.03212.1% (4,905 firms) are expected to have impacts greater than 
3% to their firm revenues (rounded metric). Excluding end-users, total 
estimated impacts on small businesses are $9.3 million (annualized 
using a 7 percent discount rate). End users with economic and 
technologically feasible alternatives available do not have economic 
impacts that are estimated beyond rule familiarization costs ($1.8 
million in total costs, annualized using a 7 percent discount rate). 
Thus, the estimated total impact of the rule on small businesses ranges 
from $11.1 to $73.6 million (see section 7.11 of the Economic 
Analysis). Commercial paint and coating removers are one product type 
where for which methylene chloride is likely the most effective product 
for many applications. In particular, alternatives to methylene 
chloride paint and coating removers in commercial furniture refinishing 
may not be as cost-effective for this use because they may take more 
time to achieve the desired outcome or require alternate processes 
affecting operations that present challenges for certain businesses. 
The impact of a prohibition of methylene chloride for furniture 
refinishing could result in the closure of an unknown number of 
affected entities or business lines. As discussed in Unit I.E., closure 
of affected furniture refinishing firms using methylene chloride 
following this rulemaking has an upper bound for economic impacts of 
$1.8 billion in total revenue, and $67 million in terms of the total 
profit, under the assumption that all affected firms fully close due to 
the restrictions on methylene chloride. A detailed discussion of 
potential economic impacts as a result of varying percentages of 
furniture refinishing firms closing is provided in the Economic 
Analysis in section 7.11 (Ref. 3).
    With respect to this proposed rule's effect on technological 
innovation, EPA expects this rule to spur more innovation than it will 
hinder. A prohibition or significant restriction on the manufacture, 
processing, and distribution in commerce of methylene chloride for uses 
covered in this proposed rule may increase demand for existing, as well 
as development of additional, safer chemical substitutes. This proposed 
rule is not likely to have significant effects on the environment 
because, as discussed in Unit VI.B., methylene chloride does not 
present an unreasonable risk to the environment, though this proposed 
rule does present the potential for small reductions in air emissions 
and soil contamination associated with improper disposal of products 
containing methylene chloride. The effects of this proposed rule on 
public health are estimated to be positive, due to the potential 
prevention of deaths from acute exposure and reduced risk of cancer 
from chronic exposure to methylene chloride.
2. Costs and Benefits of the Proposed Regulatory Action and of the One 
or More Primary Alternative Regulatory Actions Considered by the 
Administrator
    The costs and benefits that can be monetized for this proposed rule 
are

[[Page 28329]]

described at length in in the Economic Analysis (Ref. 3). The non-
closure-related costs for this proposed rule are estimated to be $13.2 
million annualized over 20 years at a 3% discount rate and $14.5 
million annualized over 20 years at a 7% discount rate. The monetized 
benefits are estimated to be $17.7 to $18.5 million annualized over 20 
years at a 3% discount rate and $13.4 to $13.9 million annualized over 
20 years at a 7% discount rate.
    EPA considered the estimated costs to regulated entities as well as 
the cost to administer and enforce alternative regulatory actions. The 
primary alternative regulatory action is described in detail in Unit 
IV.B. The estimated annualized, non-closure-related costs of the 
primary alternative regulatory action are $12.4 million at a 3% 
discount rate and $13.3 million at a 7% discount rate over 20 years 
(Ref. 3). The estimated annualized benefits of this primary alternative 
regulatory action are $17.7 to $18.5 million at a 3% discount rate and 
$13.4 to $13.9 million at a 7% discount rate over 20 years (Ref. 3).
    This proposal is expected to achieve health benefits for the 
American public, some of which can be monetized and others that, while 
tangible and significant, cannot be monetized. EPA believes that the 
balance of costs and benefits of this proposal cannot be fairly 
described without considering the additional, non-monetized benefits of 
mitigating the non-cancer adverse effects. The multitude of adverse 
effects from methylene chloride exposure can profoundly impact an 
individual's quality of life, as discussed in Units II.A. (overview), 
III.B.2. (description of the unreasonable risk), V.A. (discussion of 
the health effects), and the Risk Evaluation. Some of the adverse 
effects can be immediately experienced and can result in sudden death; 
others can have impacts that are experienced for a shorter portion of 
life but are nevertheless significant in nature. The incremental 
improvements in health outcomes achieved by given reductions in 
exposure cannot be quantified for non-cancer health effects associated 
with methylene chloride exposure, and therefore cannot be converted 
into monetized benefits. The qualitative discussion throughout this 
rulemaking and in the Economic Analysis highlights the importance of 
these non-cancer effects, which are not able to be monetized in the way 
that EPA is able to for cancer and death. These effects include not 
only cost of illness but also personal costs such as emotional and 
mental stress that are hard to measure appropriately. Considering only 
monetized benefits significantly underestimates the impacts of 
methylene chloride adverse outcomes and underestimates the benefits of 
this proposed rule. As the proposed option is more restrictive and 
therefore more protective than the primary alternative option, the 
value of unquantified benefits may be higher for the proposed option. 
This implies that the difference between the proposed and primary 
alternative options is larger than it appears, in favor of the proposed 
option, based on monetized benefits alone.
    The 2020 Risk Evaluation for Methylene Chloride identified two non-
cancer health effects in reviewed scientific literature relevant to 
children, namely reproductive and developmental hazards. The 2020 Risk 
Evaluation for Methylene Chloride summarizes human health hazards 
identified in the review of scientific literature, including studies 
investigating methylene chloride exposure and reproductive and 
developmental effects as well as developmental neurotoxicity. Some 
epidemiological studies identified effects that include reduced 
fertility, spontaneous abortions, oral cleft defects, heart defects, 
and autism spectrum disorder (ASD). For ASD, due to methodological 
reasons including confounding by other chemicals and lack of temporal 
specificity, the 2020 Risk Evaluation for Methylene Chloride did not 
advance this hazard to a dose response calculation. Additionally, EPA 
did not carry reproductive/developmental effects forward for dose-
response, because epidemiological studies lacked controls for co-
exposures, animal studies observed effects mostly at higher methylene 
chloride concentrations, and EPA identified no relevant mechanistic 
information (Ref. 1). Nonetheless, additional health benefits may be 
achieved by reducing the incidence of reproductive effects for workers 
in commercial facilities or companies that use methylene chloride for 
the commercial uses proposed to be regulated (Ref. 3).
    EPA was unable to estimate either the precise reduction in 
individual risk of these reproductive and developmental effects from 
reducing exposure to methylene chloride or the total number of cases 
avoided can be estimated due to a lack of necessary data. Nevertheless, 
reproductive hazards such as reduced fertility are important 
considerations. These health effects are serious and can have impacts 
throughout a lifetime; for example, infertility and fertility treatment 
can have deleterious social and psychological consequences such as 
mental distress (Ref. 59).
    The potential impacts of these effects include monetary impacts 
from associated healthcare costs such as fertility treatments, as well 
as complications from fertility treatments (e.g., higher multiple birth 
rates), mental stress and emotional suffering, which cannot be 
quantified or monetized but should not be ignored.
3. Cost Effectiveness of the Proposed Regulatory Action and of One or 
More Primary Alternative Regulatory Actions Considered by the 
Administrator
    Cost effectiveness is a method of comparing certain actions in 
terms of the expense per item of interest or goal. A goal of this 
proposed regulatory action is to prevent user deaths resulting from 
exposure to methylene chloride. The proposed regulatory action would 
cost, excluding closure-related costs, $9.9 million per potential 
prevented death while the primary alternative regulatory action would 
cost, excluding closure-related costs, $9.3 million per potential 
prevented death (using the 3% discount rate). While the primary 
alternative regulatory action would be lower in cost compared to the 
proposed action, the difference is small and both options are 
considered to have similar levels of cost effectiveness in decreasing 
the potential for death from exposure to methylene chloride (Ref. 3). 
See Chapter 9 of the Economic Analysis for greater detail on the cost 
effectiveness of the proposed and primary regulatory actions.
4. Requests for Comment on Economic Analysis
    As described in the Economic Analysis, two conditions of use, 
Processing: Recycling and Disposal, are responsible for the majority 
(~60%) of the estimated total $13 million non-closure-related costs of 
the rule. Given the prevalence of small entities in this sector, EPA 
requests comment on what regulatory flexibilities, within the scope of 
TSCA and mitigating unreasonable risk, may be afforded to these 
conditions of use to reduce burden of complying with the WCPP.
    As described in the Economic Analysis and the Alternatives 
Assessment, alternatives for methylene chloride as a processing aid 
were not identified. EPA requests information on potential alternative 
processing aids to methylene chloride as it relates to the proposed 
regulatory option for this COU. The Economic Analysis includes a 
qualitative discussion of uncertainty in cost estimates, including 
uncertainties related to the cost of reformulating products that 
currently contain methylene chloride, which

[[Page 28330]]

could be underestimated, or overestimated. EPA requests comment on 
additional aspects of reformulation, including any costs that may be 
associated with mitigating countervailing risks of alternative 
formulations. Additionally, EPA requests comment on the degree to which 
qualities or properties of methylene chloride, beyond those discussed 
in the Economic Analysis and summarized in Unit VI.C. may make 
methylene chloride a preferable choice when compared to alternatives 
with similar costs and effectiveness. EPA also requests comment 
regarding information to estimate transition costs to suitable 
alternatives, including how often these costs might be incurred or what 
the specific costs would be per-user or per-firm when they are 
incurred. Similarly, EPA requests comment on how costs and economic 
impacts from firm closures may be reduced with longer compliance 
timeframes. Finally, EPA requests comment on how better to monetize the 
benefits of each alternative in the Economic Analysis and whether EPA 
should consider any other categories of benefits.

VII. TSCA Section 9 Analysis and Section 14 and 26 Considerations

A. TSCA Section 9(a) Analysis

    TSCA section 9(a) provides that, if the Administrator determines, 
in the Administrator's discretion, that an unreasonable risk may be 
prevented or reduced to a sufficient extent by an action taken under a 
Federal law not administered by EPA, the Administrator must submit a 
report to the agency administering that other law that describes the 
risk and the activities that present such risk. TSCA section 9(a) 
describes additional procedures and requirements to be followed by EPA 
and the other Federal agency after submission of the report. As 
discussed in this Unit, for this proposed rule, the Administrator does 
not determine that unreasonable risk from methylene chloride under the 
conditions of use may be prevented or reduced to a sufficient extent by 
an action taken under a Federal law not administered by EPA.
    TSCA section 9(d) instructs the Administrator to consult and 
coordinate TSCA activities with other Federal agencies for the purpose 
of achieving the maximum enforcement of TSCA while imposing the least 
burden of duplicative requirements. For this proposed rule, EPA has 
coordinated with appropriate Federal executive departments and agencies 
including OSHA and the Consumer Product Safety Commission (CPSC) to 
identify their respective authorities, jurisdictions, and existing laws 
with regard to risk evaluation and risk management of methylene 
chloride, which are summarized in this Unit.
    As discussed in more detail in Unit II.C., OSHA requires that 
employers provide safe and healthful working conditions by setting and 
enforcing standards and by providing training, outreach, education, and 
assistance. OSHA has established health standards for methylene 
chloride covering employers in General Industry, Shipyards, and 
Construction (29 CFR 1910.1052(a)). Gaps exist between OSHA's authority 
to set workplace standards under the OSH Act and EPA's obligations 
under TSCA section 6 to eliminate unreasonable risk presented by 
chemical substances under the conditions of use. As noted previously, 
to set PELs for chemical exposure, OSHA must first establish that the 
new standards are economically and technologically feasible (79 FR 
61384, 61387, Oct. 10, 2014). When setting the 8-hour TWA PEL for 
methylene chloride in 1997, OSHA concluded that ``at the 25 ppm PEL the 
residual risk still greatly exceeds any significant risk threshold,'' 
but set the PEL at that level because it was the lowest level for which 
OSHA could document technological and economic feasibility across the 
affected industries at that time (62 FR 1494, 1575 January 10, 1997; 63 
FR 50172, 50713, September 22, 1998). Thus, if OSHA were to initiate a 
new action to lower its PEL, the difference in requirements between the 
OSH Act and TSCA could result in the OSHA PEL still being set at a 
higher level than the risk-based exposure limit for methylene chloride 
determined by EPA to be necessary to address the unreasonable risk 
identified under TSCA. However, EPA believes that the feasibility of 
technology has advanced over the last 25 years such that for certain 
conditions of use, based on monitoring data received during the risk 
evaluation and feedback during SBAR, EPA's risk-based level of 2 ppm is 
achievable, and indeed, is already being achieved. For most industrial 
and commercial conditions of use, EPA has determined it is not feasible 
to meet the ECEL and is thus proposing to prohibit those uses. In 
addition, OSHA may set exposure limits for workers, but its authority 
is limited to the workplace and does not extend to consumer uses of 
hazardous chemicals, and thus OSHA cannot address the unreasonable risk 
from methylene chloride under all of its conditions of use, which 
include consumer uses. OSHA also does not have direct authority over 
State and local employees, and it has no authority over the working 
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
    CPSC, under authority provided to it by Congress in the CPSA, 
protects the public from unreasonable risk of injury or death 
associated with consumer products. Under the CPSA, CPSC has the 
authority to regulate methylene chloride in consumer products, but not 
in other sectors such as automobiles, some industrial and commercial 
products, or aircraft for example. CPSC issued its methylene chloride 
guidance under the FHSA, which does not include the same jurisdictional 
exceptions as the CPSA. Recently, CPSC revised its labeling guidance 
for methylene chloride under the FHSA to provide more immediate 
guidance and clarity to consumers and industry regarding the acute 
hazards associated with using methylene chloride-based paint removers 
while they remain on the market (83 FR 12254, March 21, 2018). However, 
while EPA believes that the updated CPSC labeling guidance, if properly 
implemented by industry, would prevent some users from using methylene 
chloride paint and coating removal products in an unsafe manner, for 
the reasons described in the proposal, it is unlikely to address the 
unreasonable risks to consumers under a 9(a) determination by the 
Administrator. Furthermore, in a letter to EPA regarding paint and 
coating removers, CPSC stated ``because TSCA gives EPA the ability to 
reach both occupational and consumer uses, we recognize that EPA may 
address risks associated with these chemicals in a more cohesive and 
coordinated manner given that CPSC lacks authority to address 
occupational hazards.'' (EPA-HQ-OPPT-2016-0231-0154).
    Therefore, EPA maintains that TSCA is the appropriate vehicle to 
deliver broad protections to consumers who may use formulations that 
contain methylene chloride and whose use drives the unreasonable risk 
of injury to health from methylene chloride. An action under TSCA also 
would be able to address occupational unreasonable risk and would reach 
entities that are not subject to OSHA. The timeframe and any exposure 
reduction as a result of updating OSHA or CPSC regulations for 
methylene chloride cannot be estimated, while TSCA imposes a much more 
accelerated 2-year statutory timeframe for proposing and finalizing 
requirements to address unreasonable risk. Regulating methylene 
chloride's

[[Page 28331]]

unreasonable risk utilizing TSCA authority will also avoid the 
situation where a patchwork of regulations amongst several Agencies 
using multiple laws and differing legal standards would occur and is 
therefore a more efficient and effective means of addressing the 
unreasonable risk of methylene chloride.
    Moreover, the 2016 amendments to TSCA altered both the manner of 
identifying unreasonable risk and EPA's authority to address 
unreasonable risk, such that risk management is increasingly distinct 
from provisions of the CPSA, FHSA, or, OSH Act., In a TSCA section 6 
risk management rule, following an unreasonable risk determination, EPA 
must apply risk management requirements to the extent necessary so that 
the chemical no longer presents unreasonable risk and only consider 
costs and benefits of the regulatory action to the extent practicable, 
15 U.S.C. 2605(a) and (c)(2). By contrast, a consumer product safety 
rule under the CPSA must include a finding that ``the benefits expected 
from the rule bear a reasonable relationship to its costs.'' 15 U.S.C. 
2058(f)(3)(E). Additionally, the 2016 amendments to TSCA reflect 
Congressional intent to ``delete the paralyzing `least burdensome' 
requirement,'' 162 Cong. Rec. S3517 (June 7, 2016), a reference to TSCA 
section 6(a) as originally enacted in 1976, which required EPA to use 
``the least burdensome requirements'' that protect ``adequately'' 
against unreasonable risk, 15 U.S.C. 2605(a) (1976). However, a 
consumer product safety rule under the CPSA must impose ``the least 
burdensome requirement which prevents or adequately reduces the risk of 
injury for which the rule is being promulgated.'' 15 U.S.C. 
2058(f)(3)(F) Analogous requirements, also at variance with recent 
revisions to TSCA, affect the availability of action CPSC may take 
under the FHSA relative to action EPA may take under TSCA. 15 U.S.C. 
1262. But EPA's substantive burden under TSCA section 6(a) is to apply 
requirements to the extent necessary so that the chemical substance no 
longer presents the unreasonable risk that was determined in accordance 
with TSCA section 6(b)(4)(A) without consideration of cost or other 
non-risk factors.
    EPA therefore concludes that TSCA is the most appropriate 
regulatory authority able to prevent or reduce unreasonable risk of 
methylene chloride to a sufficient extent across the range of 
conditions of use, exposures, and populations of concern. This 
unreasonable risk can be addressed in a more coordinated, efficient, 
and effective manner under TSCA than under different laws implemented 
by different agencies. Further, there are key differences between the 
finding requirements of TSCA and those of the OSH Act, CPSA, and FHSA. 
For these reasons, in the Administrator's discretion, the Administrator 
has analyzed this issue and does not determine that unreasonable risk 
from methylene chloride may be prevented or reduced to a sufficient 
extent by an action taken under a Federal law not administered by EPA.

B. TSCA Section 9(b) Analysis

    If EPA determines that actions under other Federal laws 
administered in whole or in part by EPA could eliminate or sufficiently 
reduce a risk to health or the environment, TSCA section 9(b) instructs 
EPA to use these other authorities to protect against that risk unless 
the Administrator determines in the Administrator's ``discretion that 
it is in the public interest to protect against such risk'' under TSCA. 
In making such a public interest finding, TSCA section 9(b)(2) states: 
``the Administrator shall consider, based on information reasonably 
available to the Administrator, all relevant aspects of the risk . . . 
and a comparison of the estimated costs and efficiencies of the action 
to be taken under this title and an action to be taken under such other 
law to protect against such risk.''
    Although several EPA statutes have been used to limit methylene 
chloride exposure (Refs. 3, 7), regulations under those EPA statutes 
largely regulate releases to the environment, rather than occupational 
or consumer exposures. While these limits on releases to the 
environment are protective in the context of their respective statutory 
authorities, regulation under TSCA is also appropriate for occupational 
and consumer exposures and in some cases can provide upstream 
protections that would prevent the need for release restrictions 
required by other EPA statutes (e.g., RCRA, CAA, CWA).
    The primary exposures and unreasonable risk to consumers, 
bystanders, workers, and occupational non-users would be addressed by 
EPA's proposed prohibitions and restrictions under TSCA section 6(a). 
In contrast, the timeframe and any exposure reduction as a result of 
updating regulations for methylene chloride under RCRA, CAA, or CWA 
cannot be estimated, nor would they address the direct human exposure 
to consumers, bystanders, workers, and occupational non-users from the 
conditions of use evaluated in the 2020 Risk Evaluation for Methylene 
Chloride. More specifically, none of EPA's other statutes (e.g., RCRA, 
CAA, and CWA) can address exposures to workers and occupational non-
users related to the specific activities that result in occupational 
exposures associated with disposal activities. EPA therefore concludes 
that TSCA is the most appropriate regulatory authority able to prevent 
or reduce risks of methylene chloride to a sufficient extent across the 
range of conditions of use, exposures, and populations of concern.
    For these reasons, the Administrator does not determine that 
unreasonable risk from methylene chloride under its conditions of use, 
as evaluated in the 2020 Risk Evaluation for Methylene Chloride, could 
be eliminated or reduced to a sufficient extent by actions taken under 
other Federal laws administered in whole or in part by EPA.

C. TSCA Section 14 Requirements

    EPA is also providing notice to manufacturers, processors, and 
other interested parties about potential impacts to confidential 
business information that may occur if this rule is finalized as 
proposed. Under TSCA sections 14(a) and 14(b)(4), if EPA promulgates a 
rule pursuant to TSCA section 6(a) that establishes a ban or phase-out 
of a chemical substance, the protection from disclosure of any 
confidential business information regarding that chemical substance and 
submitted pursuant to TSCA will be ``presumed to no longer apply,'' 
subject to the limitations identified in TSCA section 14(b)(4)(B)(i) 
through (iii). If this rule is finalized as proposed, then pursuant to 
TSCA section 14(b)(4)(B)(iii), the presumption against protection from 
disclosure would apply only to information about the specific 
conditions of use that this rule would prohibit or phase out. 
Similarly, if this rule is finalized as proposed, the presumption 
against protection from disclosure would not apply to certain uses that 
this rule proposes to exempt from the ban or phase-out pursuant to TSCA 
section 6(g). Per TSCA section 14(b)(4)(B)(i), the presumption against 
protection would not apply to information about these conditions of 
use. However, the presumption against protection would apply to 
information about conditions of use that are not exempt from the ban or 
phase-out, pursuant to TSCA section 6(g). Manufacturers or processors 
seeking to protect such information would be able to submit a request 
for nondisclosure as provided by TSCA sections 14(b)(4)(C) and 
14(g)(1)(E). Any request for nondisclosure would need to be

[[Page 28332]]

submitted within 30 days after receipt of notice from EPA under TSCA 
section 14(g)(2)(A). EPA anticipates providing such notice via the 
Central Data Exchange (CDX).

D. TSCA Section 26 Considerations

    In accordance with TSCA section 26(h), EPA has used scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, and models consistent with the best available science. 
As in the case of the unreasonable risk determination, risk management 
decisions for this proposed rule, as discussed in Unit III.B.3. and 
Unit V., were based on a risk evaluation that was subject to public 
comment and independent, expert peer review, and developed in a manner 
consistent with the best available science and based on the weight of 
the scientific evidence as required by TSCA sections 26(h) and (i) and 
40 CFR 702.43 and 702.45. In particular, the ECEL and EPA STEL values 
incorporated into the WCPP are derived from the analysis in the 2020 
Risk Evaluation for Methylene Chloride; they likewise represent 
decisions based on the best available science and the weight of the 
scientific evidence (Ref. 11). The ECEL value of 2 ppm as an 8-hour TWA 
is based on the chronic non-cancer human equivalent concentration (HEC) 
for liver toxicity identified in the 2020 Risk Evaluation for Methylene 
Chloride, which is the concentration at which an adult human would be 
unlikely to suffer adverse effects if exposed for a working lifetime, 
including susceptible subpopulations. The EPA STEL of 16 ppm as a 15-
minute TWA is derived from the non-cancer endpoint of central nervous 
system depression resulting from acute exposures that was identified in 
the 2020 Risk Evaluation for Methylene Chloride.
    The extent to which the various information, procedures, measures, 
methods, protocols, methodologies, or models, as applicable, used in 
EPA's decisions have been subject to independent verification or peer 
review is adequate to justify their use, collectively, in the record 
for this rule. Additional information on the peer review and public 
comment process, such as the peer review plan, the peer review report, 
and the Agency's response to public comments, can be found at EPA's 
risk evaluation docket at EPA-HQ-OPPT-2020-0465.

VIII. Requests for Comment

    EPA is requesting public comment on all aspects of this proposal, 
including the proposed and primary alternative regulatory actions and 
all supporting analysis. Additionally, within this proposal, the Agency 
is soliciting feedback from the public on specific issues throughout 
this proposed rule. For ease of review, this section summarizes those 
specific requests for comment.
    1. EPA is requesting public comment on the proposed regulatory 
action and primary alternative regulatory action. (Unit III.A.).
    2. EPA is requesting comment on the proposed rule's TSCA section 
6(g) exemptions' provisions and rationales. (Unit III.A.).
    3. Following Panel recommendations in the Panel report (Ref. 6) and 
in response to SERs recommendations, EPA is requesting comment on the 
following topics as outlined in the SBAR Panel Report:
    a. EPA requests comment on the extent to which a regulation under 
TSCA section 6(a) could minimize requirements, such as testing and 
monitoring protocols, recordkeeping, and reporting requirements, which 
may exceed those already required under OSHA's regulations for 
methylene chloride.
    b. EPA requests comment on the feasibility of complying with and 
monitoring for an Existing Chemical Exposure Limit (ECEL) of 2 ppm. In 
particular, EPA requests comment on changes that may be needed to meet 
such a standard, for example changes related to elimination of 
methylene chloride or substitution, engineering controls, process 
changes, and monitoring frequency.
    c. EPA requests comment on workplace monitoring for implementation 
of an ECEL. EPA is soliciting information related to the frequency of 
monitoring, initial monitoring, and periodic monitoring for workplace 
exposure levels and how a lower exposure level from the OSHA PEL may 
impact the frequency of periodic monitoring. Specifically, EPA requests 
comment about when this may impact the frequency of periodic monitoring 
where initial monitoring shows that employee exposures are above the 
level that would initiate requirements for compliance with the ECEL or 
an OSHA STEL.
    d. EPA requests comment on reasonable compliance timeframes for 
small businesses, including timeframes for reformulation of products or 
processes containing methylene chloride; implementation of new 
engineering or administrative controls; changes to labels, SDSs, and 
packaging; implementation of new PPE, including training and monitoring 
practices; and supply chain management challenges. EPA also requests 
comment on establishing differing compliance or reporting requirements 
or timetables that take into account the limited resources available to 
small entities.
    e. EPA requests comment on the feasibility and availability of 
various prescriptive engineering controls to reduce exposure levels, 
and information on any technologies or prescriptive control options 
used in combination for addressing the unreasonable risk.
    f. EPA requests comment on providing an option of either complying 
with the ECEL or implementing various administrative and engineering 
controls, such as those employed in a closed-loop system, including 
information on how a small business can demonstrate that such controls 
eliminate the unreasonable risk for that use.
    g. EPA requests comment on establishing a certification program for 
the use of methylene chloride by the furniture refinishing industry as 
well as measures to address the unreasonable risk for commercial use of 
methylene chloride in paint and coating removal for furniture 
refinishing.
    h. EPA requests comment on means by which small businesses can 
maintain access to methylene chloride for industrial and commercial 
uses including establishing training, certification, and limited access 
programs.
    i. EPA requests comment on TSCA section 6(g)(1) exemptions for any 
MIL-SPEC programs where methylene chloride is specified or required for 
a specific end-use application.
    j. EPA requests comment on temporary work practices to allow for 
limited circumstances, including but not limited to equipment failure 
or maintenance activity, where monitoring may not be feasible to comply 
with an ECEL.
    k. EPA requests comment on the extent to which methylene chloride 
may be used in the same facility for TSCA and non-TSCA uses.
    4. EPA requests comment on whether a definition should be 
promulgated for each condition of use of methylene chloride and, if so, 
whether the descriptions in Unit III.B.1.f. are consistent with the 
conditions of use evaluated in the 2020 Risk Evaluation for Methylene 
Chloride and whether they provide a sufficient level of detail such 
that they would improve the clarity and readability of the regulation 
if promulgated. (Unit III.B.1.f.).
    5. EPA is requesting comment on the proposed implementation 
timeframe for the WCPP requirements; EPA proposes that they would take 
effect 180 days

[[Page 28333]]

after publication of the final rule, at which point entities would be 
required to conduct initial monitoring (as described in Unit IV.A.1.c.) 
and develop an exposure control plan within 1 year of publication of 
the final rule (Unit IV.A.1.a. and d.). (Unit IV.A.1.a.).
    6. EPA acknowledges that new monitoring methods or technologies may 
have been developed since 1997 that would allow for greater accuracy, 
and thus a smaller range for monitoring results, and EPA requests 
comment on the exposure monitoring accuracy requirements. (Unit 
IV.A.1.c.i.).
    7. EPA acknowledges that the 25% buffer for the 8-hour and 15-
minute TWA potentially could allow some exposures above the exposure 
limits proposed here. EPA requests comment on these buffers' effects 
and any alternatives to account for measurement variance or 
uncertainty. (Unit IV.A.1.c.i.).
    8. EPA is soliciting comments regarding how owners and operators 
could conduct initial exposure monitoring to ensure that it is 
representative of all tasks likely to be conducted by potentially 
exposed persons. (Unit IV.A.1.c.ii.).
    9. EPA is soliciting comments regarding the proposed requirement 
for recurring 5-year initial exposure monitoring. (Unit IV.A.1.c.ii.).
    10. EPA requests comment on the timeframes for periodic monitoring 
outlined in Unit IV.A.1.c.iii, particularly whether more frequent 
monitoring may be possible or recommended. (Unit IV.A.1.c.iii.).
    11. EPA is requesting public comments on the proposed conditions 
for periodic monitoring for methylene chloride as part of 
implementation of the WCPP that differ from OSHA's existing monitoring 
requirements under 29 CFR 1910.1052. (Unit IV.A.1.c.iv.).
    12. EPA requests comment on the degree to which additional guidance 
related to use of gloves might be necessary. Additionally, EPA requests 
comment on whether EPA should specifically incorporate dermal 
protection into the exposure control plan and require consideration of 
the hierarchy of controls for dermal exposures. (Unit IV.A.1.e.i.).
    13. EPA requests comment on the 15-day timeframe for notification 
of potentially exposed persons of monitoring results and the 
possibility for a shorter timeframe, such as 5 days. (Unit 
IV.A.1.f.ii.).
    14. EPA requests comment relative to the ability of owners or 
operators to conduct initial monitoring by 180 days after publication 
of the final rule, and anticipated timelines for any procedural 
adjustments needed to comply with the requirements outlined in Unit 
IV.A.1. (Unit IV.A.1.g.).
    15. EPA requests comment on the impacts, if any, the proposed 
prohibition described in Unit IV.A.2., or other aspects of this 
proposal, may have on the production and availability of any food, food 
additive, drug, cosmetic, device, or other substance excluded from the 
definition of ``chemical substance'' under TSCA section 3(2)(B)(ii) 
through (vi). (Unit IV.A.2.).
    16. EPA requests comment regarding the number of entities that 
could potentially close as well as associated costs with a prohibition 
of methylene chloride for certain industrial and commercial conditions 
of use identified in Unit IV.A.2. (Unit IV.A.2.).
    17. EPA would like comment on whether it should consider a de 
minimis level of methylene chloride in formulations for certain 
continuing industrial and commercial uses to account for impurities 
(e.g., 0.1% or 0.5%) when finalizing the prohibitions described in Unit 
IV.A., and, if so, what level should be considered de minimis (Units 
IV.A.2., and IV.A.3.).
    18. EPA is proposing that the prohibition of certain industrial and 
commercial conditions of use described in Unit IV.A.2 would occur 90 
days after the publication date of the final rule for manufacturers, 
180 days for processors, 270 days for distributing to retailers, 360 
days for all other distributors and retailers, and 450 days for 
industrial and commercial uses. EPA requests comment on whether 
additional time is needed, for example, for products affected by 
proposed restrictions to clear the channels of trade. (Unit IV.A.2.).
    19. EPA requests comments on an appropriate, predictable process 
that could expedite reconsideration for uses that Federal agencies or 
their contractors become aware of after the final rule is issued using 
the tools available under TSCA, aligning with the requirements of TSCA 
section 6(g). EPA requests comment on the appropriate types of 
information for use in evaluating this type of category of use, and 
other considerations that should apply. (Unit IV.A.2).
    20. EPA would like comment on whether distributors that are not 
retailers should be required to use tax IDs or other verification 
methods prior to selling methylene chloride or products containing 
methylene chloride to ensure consumers are not purchasing methylene 
chloride or commercial or industrial products containing methylene 
chloride. (Unit IV.A.3.).
    21. During litigation (see Lab. Council for Latin Am. Advancement 
v. United States Env't Prot. Agency, 12 F.4th 234 (2d Cir. 2021)) on a 
previous rulemaking (84 FR 11420, March 27, 2019) petitioners argued 
that EPA's definition of ``retailer'' was so broad as to cover all 
commercial entities, creating supply chain issues for commercial users 
seeking to attain and use the chemical for commercial activities. EPA 
has not found this to be the case; small businesses that are non-retail 
distributors exist and even participated as small entity 
representatives consulted as part of the SBAR process for this 
rulemaking. Nonetheless, EPA is soliciting comment on whether similar 
supply chain issues for uses that are permitted under the WCPP are 
anticipated. (Unit IV.A.3.).
    22. EPA is proposing that the prohibition of manufacturing, 
processing, and distribution for consumer use described in Unit IV.A.3. 
would occur 90 days after the publication date of the final rule for 
manufacturers, 180 days for processers, 270 days for distributing to 
retailers, and 360 days for all other distributors and retailers after 
the publication date of the final rule. EPA requests comment on whether 
additional time is needed, for example, for products affected by 
proposed restrictions to clear the channels of trade. (Unit IV.A.3.).
    23. EPA requests comments on the appropriateness of identified 
compliance timeframes for recordkeeping and downstream notification 
requirements described in Unit IV.A.4. (Unit IV.A.4.b.).
    24. EPA recognizes that in some situations, certain facilities may 
do both Federal contractor and commercial aviation work and may use 
methylene chloride for paint and coating removal from safety-critical, 
corrosion-sensitive components on military, Federal, or commercial 
aviation. EPA requests comment on whether such co-located activities in 
a facility should be subject to the WCPP, rather than the exemption 
under TSCA section 6(g). Additionally, EPA seeks additional information 
and requests comment on whether it is possible to distinguish between 
commercial aviation facilities that would be able to meet the WCPP and 
those that would not, including what criteria should be used for such 
distinctions (e.g., size of facility, volume or type of work performed, 
record of exposure reduction practices). EPA also requests comment on 
the extent to which specific commercial aviation and aerospace uses or 
types of facilities could fully comply with the WCPP to address 
identified unreasonable risk. (Unit IV.A.5.a.i.).

[[Page 28334]]

    25. EPA requests comments on all aspects of the proposed TSCA 
section 6(g) exemption from the proposed prohibition on use of 
methylene chloride in commercial paint and coating removal for paint 
and coating removal essential for critical infrastructure by 
certificated commercial air carriers, commercial operators, or repair 
stations, or by manufacturers of aircraft or aerospace vehicles and 
hardware, noting that the proposed exemptions would be limited to the 
safety-critical, corrosion-sensitive components on aircraft and 
aerospace vehicles, including safety-critical components. (Unit 
IV.A.5.a.ii.).
    26. EPA requests comment on this TSCA section 6(g) exemption for 
continued emergency use of methylene chloride in the furtherance of 
NASA's mission as described in this unit, and whether any additional 
conditions of use should be included, in particular for any uses 
qualified for space flight for which no technically or economically 
feasible safer alternative is available. Additionally, EPA requests 
comment on what would constitute sufficient justification of an 
emergency. (Unit IV.A.5.b.ii.).
    27. EPA requests comments on all aspects of the preliminary 
determination that a TSCA section 6(g) exemption is not warranted for 
the use of methylene chloride in furniture refinishing, including 
information on the availability of alternatives and the time needed to 
implement alternatives. EPA emphasizes that the Agency is seeking input 
regarding whether an exemption is needed and welcomes information 
related to this condition of use during the public comment period. 
(Unit IV.A.5.c.).
    28. Primary alternative regulatory action: EPA requests comment on 
the ways in which methylene chloride may be used in the additional 
conditions of use that would be subject to a WCPP under the primary 
alternative regulatory action, and the degree to which users of 
methylene chloride in these sectors could successfully implement the 
WCPP, including requirements to meet an ECEL and EPA STEL, as described 
in Unit IV.A.1., for the conditions of use listed for the primary 
alternative regulatory action in Unit IV.B. EPA is also requesting 
comment on whether to consider a regulatory alternative that would 
subject more conditions of use to a WCPP, instead of prohibition, than 
those currently contemplated in the primary alternative regulatory 
action. EPA also requests monitoring data and detailed descriptions of 
methylene chloride involving activities for these conditions of use to 
determine whether these additional conditions of use could comply with 
the WCPP such that risks are no longer unreasonable. (Unit IV.B.).
    29. Primary alternative regulatory action: EPA requests comment on 
the degree to which entities using methylene chloride as a processing 
aid may comply with the proposed WCPP requirements for methylene 
chloride. EPA requests comment on the degree to which alternatives may 
or may not be available for use of methylene chloride as a heat 
transfer fluid and in other processing aid applications. (Unit IV.B.).
    30. Primary alternative regulatory action: EPA requests comment on 
the ability of regulated entities engaged in the additional conditions 
of use that would be subject to a WCPP under the primary alternative 
regulatory action to conduct initial monitoring within 12 months, 
anticipated timelines for any procedural adjustments needed to comply 
with the requirements, and the extent to which this option could result 
in additional exposure, compared the proposed regulatory option as 
described in Unit IV.A. Overall, EPA requests comment on any advantages 
or drawbacks for the timelines outlined in Unit IV.B., compared to the 
timelines identified for the proposed regulatory action in Unit IV.A. 
(Unit IV.B.)
    31. EPA requests comment and further information regarding the 
Agency's expectations that Federal and Federal contractor facilities 
would be subject to a higher level of oversight than non-Federal or 
contractor facilities, and that existing or expected controls would be 
successful in achieving the requirements of the WCPP. (Unit V.A.1.).
    32. EPA requests comment and further information regarding the 
Agency's expectations that the facilities in which use of methylene 
chloride as a bonding agent in specialty batteries is carried out are 
industrialized and highly controlled, and that existing or expected 
exposure reduction and workplace controls would be successful in 
achieving the requirements of the WCPP. EPA also notes that while the 
Agency is not aware of any similar use of methylene chloride as a 
bonding element for batteries for commercial spaceflight or other use, 
it requests comment and information on any such use. (Unit V.A.1.).
    33. EPA is requesting comment on what regulatory flexibilities may 
be afforded to entities that will continue to recycle and dispose of 
methylene chloride under the proposed regulation. (Unit V.A.1.).
    34. EPA is requesting comment on the inclusion of a certification, 
training, and limited access program for any uses that would be subject 
to a WCPP, in addition to the requirements outlined in Unit IV.A.1. 
(Unit V.A.4.).
    35. For some conditions of use, EPA was unable to identify products 
currently available for sale that contain methylene chloride. EPA is 
soliciting comments on whether there are actually products in use or 
available for sale relevant to these conditions of use that contain 
methylene chloride at this time, so that EPA can ascertain whether 
there are alternatives that benefit human health or the environment. 
(Unit V.B.).
    36. EPA is requesting comment on the alternatives analysis as a 
whole. (Unit V.B.).
    37. EPA considered the employment impacts of this proposed rule, 
and found that the direction of change in employment is uncertain, but 
EPA expects the short-term and longer-term employment effects to be 
small. To that end, EPA is requesting public comment on short term and 
longer-term employment effects from this proposal. (Unit VI.D.1.).
    38. As described in the Economic Analysis, two conditions of use, 
Processing: Recycling and Disposal, are responsible for the majority 
(~60%) of the estimated total $12 million in non-closure-related costs 
of the rule. Given the prevalence of small entities in this sector, EPA 
requests comment on what regulatory flexibilities, within the scope of 
TSCA and mitigating unreasonable risk, may be afforded to these 
conditions of use to reduce burden of complying with the WCPP. (Unit 
VI.D.4.).
    39. As described in the Economic Analysis and the Alternatives 
Analysis, alternatives for methylene chloride as a processing aid were 
not identified. EPA requests information on potential alternative 
processing aids to methylene chloride as it relates to the proposed 
regulatory option for this COU. (Unit VI.D.4.).
    40. The Economic Analysis includes a qualitative discussion of 
uncertainty in cost estimates, including uncertainties related to the 
cost of reformulating products that currently contain methylene 
chloride, which could be underestimated, or overestimated. EPA requests 
comment on additional aspects of reformulation, including any costs 
that may be associated with mitigating countervailing risks of 
alternative formulations. (Unit VI.D.4.)
    41. EPA requests comment on the degree to which qualities or 
properties of methylene chloride, beyond those discussed in the 
Economic Analysis and summarized in Unit VI.C., may make methylene 
chloride a preferable choice when compared to alternatives with

[[Page 28335]]

similar costs and effectiveness. (Unit VI.D.4.)
    42. EPA requests comment regarding information to estimate 
transition costs to suitable alternatives, including how often these 
costs might be incurred or what the specific costs would be per-user or 
per-firm when they are incurred. (Unit VI.D.4.)
    43. EPA requests comment on how costs and economic impacts from 
firm closures may be reduced with longer compliance timeframe. (Unit 
VI.D.4.)
    44. EPA requests comment on how better to monetize the benefits of 
each alternative in the Economic Analysis and whether EPA should 
consider any other categories of benefits. (Unit VI.D.4.)

IX. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not itself physically located in the 
docket. For assistance in locating these other documents, please 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Risk Evaluation for Methylene Chloride (MC). EPA Document 
#740-R1-8010
2. EPA. Final Revised Unreasonable Risk Determination for Methylene 
Chloride. November 2022.
3. EPA. Economic Analysis of the Proposed Regulation of Methylene 
Chloride. RIN 2070-AK70. August 2022.
4. Public Workshop on Use of Methylene Chloride in Furniture 
Refinishing in collaboration with the Small Business Administration 
Office of Advocacy. September 12, 2017.
5. EPA Workshop on Furniture Refinishing and Methylene Chloride. 
September 12, 2017.
6. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA) 
Section 6(a) Methylene Chloride. October 28, 2021.
7. EPA. Regulatory Actions Pertaining to Methylene Chloride. January 
24, 2023.
8. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16, 
2022.
9. NIOSH. Hierarchy of Controls. Accessed October 6, 2022
10. EPA. Methylene Chloride; Revision to Toxic Substances Control 
Act (TSCA) Risk Determination; Notice of Availability. Federal 
Register (87 FR 67901, November 10, 2022
11. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational 
Use of Methylene Chloride. December 10, 2020.
12. OSHA. Standard Interpretations: 8-hr total weight average (TWA) 
permissible exposure limit (PEL). Accessed October 6, 2022.
13. Putz et al. A comparative study of the effects of carbon 
monoxide and methylene chloride on human performance. J Environ 
Pathol Toxicol 2: 97-112. 1979.
14. NTP. NTP Toxicology and Carcinogenesis Studies of 
Dichloromethane (Methylene Chloride) (CAS No. 75-09-2) in F344/N 
Rats and B6C3F1 Mice (Inhalation Studies). National Toxicology 
Program technical report series vol. 306. 1986.
15. K.D. Nitschke; et al. Methylene Chloride: A 2-Year Inhalation 
Toxicity and Oncogenicity Study in Rats. Fundam Appl Toxicol 11: 48-
59. 1988.
16. K.D. Nitschke; et al. Methylene Chloride: Two-Generation 
Inhalation Reproductive Study in Rats. Fundam Appl Toxicol 11: 60-
67. 1988.
17. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. 
Federal Register (86 FR 7037, January 25, 2021).
18. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 25, 2021).
19. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register (86 FR 7619, February 1, 2021).
20. EPA Press Release. EPA Announces Path Forward for TSCA Chemical 
Risk Evaluations. June 2021.
21. SACC. Science Advisory Committee on Chemicals Meeting Minutes 
and Final Report No. 2022-01. March 15-17, 2022.
22. EPA. Notes from Federalism Consultation on Forthcoming Proposed 
Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA 
Section 6(a). Office of Pollution Prevention and Toxics. October 22, 
2023.
23. EPA. Notes from Tribal Consultations on Forthcoming Proposed 
Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA 
Section 6(a). Office of Pollution Prevention and Toxics. November 
12-17, 2020.
24. Liz Hitchcock; Safer Chemicals Healthy Families. 11/20 
Environmental Justice Consultations for 1-Bromopropane and Methylene 
Chloride. November 20, 2020.
25. California Communities Against Toxics et al. Comment letter re 
TSCA environmental justice consultations. November 13, 2020.
26. Swati Rayasam; Program on Reproductive Health and the 
Environment (PRHE). PRHE follow up documents from EJ consultation 
meeting. November 30, 2020.
27. EPA. Initial Regulatory Flexibility Analysis for Methylene 
Chloride; Regulation of Methylene Chloride under TSCA Sec.  6(a) 
Proposed Rule; RIN 2070-AK70. November 22, 2022.
28. EPA. Methylene Chloride: Risk Evaluation and Risk Management 
under TSCA Section 6. SBA Small Business Roundtable. September 11, 
2020.
29. EPA. Stakeholder Meeting List for Proposed Rulemaking for 
Methylene Chloride under TSCA Section 6(a). October 27, 2022.
30. EPA. 2021 Policy on Children's Health. October 5, 2021.
31. Steve Shestag; The Boeing Company. Re: Comments Supporting 
Request for Additional Information on Methylene Chloride; Rulemaking 
Under TSCA Section 6(a). June 24, 2022.
32. Anh Hoang; Kathleen Fagan; Dawn L. Cannon; et al. Assessment of 
Methylene Chloride-Related Fatalities in the United States, 1980-
2018. JAMA Intern Med. 2021.
33. DHHS Centers for Disease Control and Prevention. NIOSH Chemical 
Carcinogen Policy. Publication No. 2017-100. July 2017.
34. OSHA. Final Rule. Occupational Exposure to Methylene Chloride. 
Federal Register (62 FR 1494, of January 10, 1997).
35. OSHA; NIOSH. Hazard Alert: Methylene Chloride Hazards for 
Bathtub Refinishers. January 2013.
36. OSHA. 1910.1052 App A--Substance Safety Data Sheet and Technical 
Guidelines for Methylene Chloride. Accessed October 6, 2022.
37. EPA. Final Rule. Methylene Chloride; Regulation of Paint and 
Coating Removal for Consumer Use Under TSCA Section 6(a). Federal 
Register (84 FR 11420, March 27, 2019
38. Leslie Riegle. Re: Regulation of Certain Uses Under Toxic 
Substances Control Act: Methylene Chloride and N-methylpyrrolidone. 
Aerospace Industries Association (AIA). May 19, 2017.
39. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016.
40. EPA. An Alternatives Assessment for Use of Methylene Chloride. 
August 2022.
41. White House. United States Space Priorities Framework. December 
2021.
42. Federal Aviation Administration (FAA). Flight Program 
Operations. Last updated: April 13, 2022.
43. Aaron Rice; EaglePicher Technologies. Re: TSCA Section 6(g) 
Exemption Request for Use of N-methylpyrrolidone and Methylene 
Chloride in Production of Specialized Batteries. June 3, 2022.
44. EPA. Meeting with Arkema and EPA to discuss comments submitted 
by Arkema on Trichloroethylene (TCE) and Methylene Chloride. 
December 7, 2017.
45. Halogenated Solvents Industry Alliance Inc. (HSIA). Docket No. 
EPA-HQ-OPPT-2016-0742. August 16, 2018.
46. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA) 
Section 6(a) Methylene Chloride. Appendix B: Written Comments 
Submitted by Small Entity Representatives. October 28, 2021.
47. EPA. Proposed Rule. Methylene Chloride and N-Methylpyrrolidone; 
Regulation of Certain Uses Under TSCA Section 6(a). Federal Register 
(82 FR 7464, January 19, 2017
48. Kenneth M. Walter and Val C. Sackmann. Material Substitution of 
Methylene Chloride (MeCl)/Phenol Paint Stripper. AIHce 2016. May 21-
26, 2016.

[[Page 28336]]

49. EPA. Meeting with Baron-Blakeslee on Risk Management under TSCA 
Section 6 for Trichloroethylene, Perchloroethylene, 1-Bromopropane, 
and Methylene Chloride. April 1, 2021
50. EPA. ANPRM. Methylene Chloride; Commercial Paint and Coating 
Removal Training, Certification and Limited Access Program. Federal 
Register (84 FR 11466, March 27, 2019
51. EPA. Notes from Environmental Justice Consultations on 
Forthcoming Proposed Rulemakings for Methylene Chloride and 1-
Bromopropane under TSCA Section 6(a). Office of Pollution Prevention 
and Toxics. November 16-19, 2020.
52. EPA. Risk Calculator for Consumer Inhalation and Dermal 
Exposures. June 2020.
53. John Kelley and Thomas Considine. Performance Evaluation of Hap-
Free Paint Strippers vs. Methylene-Chloride-Based Strippers for 
Removing Army Chemical Agent Resistant Coatings (CARC). Army 
Research Laboratory. June 2006.
54. Benzyl Alcohol Paint Stripping. Joint Service Pollution 
Prevention Opportunity Handbook. May 1, 2016.
55. EPA. Methylene Chloride: Fenceline Technical Support--Water 
Pathway. October 19, 2022.
56. OEJECR EPA Complaint Nos. 01R-22-R6-, 02R-22-R6, and 04R-22-R6. 
October 12, 2022.
57. EPA. Methylene Chloride: TRI Release Data Sensitivity Analysis. 
September 1, 2022.
58. OMB. Guidance for Implementing Title II of [UMRA]. March 31, 
1995.
59. Tara M. Cousineau and Alice D. Domar. Psychological Impact of 
Infertility. Best Practice & Research Clinical Obstetrics and 
Gynaecology, Vol. 21, Issue 2. 2007.
60. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA): Regulation of 
Methylene Chloride under TSCA Section 6(a
61. EPA. TSCA Work Plan Chemical Risk Assessment; Methylene 
Chloride: Paint Stripping Use. EPA Document #740-R1-4003. August 
2014. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-risk-assessment-methylene.
62. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical 
Methods with Related International Voluntary Consensus Standards. J 
Occup Environ Hyg. 12(7):D107-15. 2015.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 13563: 
Improving Regulation and Regulatory Review

    This action is an economically significant regulatory action that 
was submitted to the Office of Management and Budget (OMB) for review 
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 
(76 FR 3821, January 21, 2011). Any changes made in response to OMB 
recommendations during that review have been documented in the docket. 
EPA prepared an Economic Analysis of the potential costs and benefits 
associated with this action, which is available in the docket and is 
summarized in Units I.E. and VI.D. (Ref. 3).

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted to OMB for review and comment under the PRA, 44 U.S.C. 
3501 et seq. The Information Collection Request (ICR) document that EPA 
prepared has been assigned EPA ICR No. 2735.01 (Ref. 60). You can find 
a copy of the ICR in the docket for this rule, and it is briefly 
summarized here.
    There are two primary provisions of the proposed rule that may 
increase burden under the PRA.
    The first is downstream notification, which would be carried out by 
updates to the relevant SDS and which would be required for 
manufacturers, processors, and distributors in commerce of methylene 
chloride, who would provide notice to companies downstream upon 
shipment of methylene chloride about the prohibitions. The information 
submitted to downstream companies through the SDS would provide 
knowledge and awareness of the restrictions to these companies.
    The second primary provision of the proposed rule that may increase 
burden under the PRA is WCPP-related information generation, 
recordkeeping, and notification requirements (including development of 
exposure control plans; exposure level monitoring and related 
recordkeeping; development of documentation for a PPE program and 
related recordkeeping; development of documentation for a respiratory 
protection program and related recordkeeping; development and 
notification to potentially exposed persons (employees and others in 
the workplace) about how they can access the exposure control plans, 
exposure monitoring records, PPE program implementation documentation, 
and respirator program documentation; and development of documentation 
demonstrating eligibility for an exemption from the proposed 
prohibitions, and related recordkeeping).
    Respondents/affected entities: Persons that manufacture, process, 
use, distribute in commerce, or dispose of methylene chloride or 
products containing methylene chloride. See also Unit I.A.
    Respondent's obligation to respond: Mandatory (TSCA section 6(a) 
and 40 CFR part 751).
    Frequency of response: On occasion.
    Estimated number of respondents: 237,929.
    Total estimated burden: 129,772 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $10,385,871 (per year), includes $2,809,809 
annualized capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. After display in the Federal 
Register when approved, the OMB control numbers for EPA regulations in 
40 CFR are listed in 40 CFR part 9 and displayed on the form and 
instructions or collection portal, as applicable.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden to the EPA using the docket identified 
at the beginning of this proposed rule. You may also send your ICR-
related comments to OMB's Office of Information and Regulatory Affairs 
using the interface at https://www.reginfo.gov/public/do/PRAMain. Find 
this particular information collection by selecting ``Currently under 
Review--Open for Public Comments'' or by using the search function. OMB 
must receive comments no later than July 3, 2023. EPA will respond to 
any ICR-related comments in the final rule.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA 
prepared an initial regulatory flexibility analysis (IRFA) that 
examines the impact of the proposed rule on small entities along with 
regulatory alternatives that could minimize that impact (Ref. 27). The 
complete IRFA is available for review in the docket and is summarized 
here.
1. Need for the Rule
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines 
after a TSCA section 6(b) risk evaluation that a chemical substance 
presents an unreasonable risk of injury to health or the environment, 
without consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant to

[[Page 28337]]

the risk evaluation, under the conditions of use, EPA must by rule 
apply one or more requirements listed in TSCA section 6(a) to the 
extent necessary so that the chemical substance or mixture no longer 
presents such risk. Methylene chloride was the subject of a risk 
evaluation under TSCA section 6(b)(4)(A) that was issued in June 2020. 
In addition, in 2022, EPA issued a revised unreasonable risk 
determination that methylene chloride as a whole chemical substance 
presents an unreasonable risk of injury to health under the conditions 
of use. As a result, EPA is proposing to take action to the extent 
necessary so that methylene chloride no longer presents such risk.
2. Objectives and Legal Basis for the Rule
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines 
through a TSCA section 6(b) risk evaluation that a chemical substance 
presents an unreasonable risk of injury to health or the environment, 
EPA must by rule apply one or more requirements listed in TSCA section 
6(a) to the extent necessary so that the chemical substance or mixture 
no longer presents such risk. EPA has determined through a TSCA section 
6(b) risk evaluation that methylene chloride presents an unreasonable 
risk under the conditions of use.
3. Description and Number of Small Entities to Which the Rule Will 
Apply
    The proposed rule potentially affects small manufacturers 
(including importers), processors, distributors, retailers, users of 
methylene chloride or of products containing methylene chloride, and 
entities engaging in disposal. EPA estimates that the proposed rule 
would affect approximately 237,930 firms using methylene chloride, of 
which 230,266 are estimated to be small entities. End users with 
economic and technologically feasible alternatives available do not 
have estimated cost impacts beyond rule familiarization costs. 
Alternative products that are drop-in substitutes (i.e., requiring no 
changes by the user in how the product is used) are available for most 
uses including adhesives, various degreasers, or lubricants and 
greases. However, in some cases some effort might be required by firms 
using methylene chloride products to identify suitable alternatives, 
test them for their desired applications, learn how to use them safely 
and effectively, and implement new processes for using the alternative 
products. The information to estimate how often these costs might be 
incurred or what the specific costs would be per-user or per-firm when 
they are incurred is not available. Therefore, EPA is unable to 
consider these costs quantitatively in the IRFA or Economic Analysis.
4. Projected Compliance Requirements
    To address the unreasonable risk EPA has identified, EPA is 
proposing to: (i) Prohibit the manufacture (including import), 
processing, and distribution in commerce of methylene chloride for all 
consumer use (other than the use of methylene chloride in consumer 
paint and coating removers, which was subject to separate action under 
TSCA section 6 (84 FR 11420, March 27, 2019); (ii) prohibit most 
industrial and commercial uses of methylene chloride; (iii) require a 
WCPP for certain industrial and commercial conditions of use, including 
inhalation exposure concentration limits; (iv) require recordkeeping 
and downstream notification requirements for several conditions of use; 
and (v) provide time-limited exemptions under TSCA section 6(g) for 
military and civilian aviation from the prohibition addressing the use 
of methylene chloride for paint and coating removal to avoid 
significant disruptions to national security and critical 
infrastructure.
    EPA is proposing to prohibit most conditions of use. For other 
conditions of use that drive the unreasonable risk determination for 
methylene chloride, EPA proposes a WCPP to address the unreasonable 
risk. A WCPP would encompass inhalation exposure thresholds, includes 
monitoring and recordkeeping requirements to verify that those 
thresholds are not exceeded, and other components, such as dermal 
protection, to ensure that the chemical substance no longer presents 
unreasonable risk. Under a WCPP, owners or operators would have some 
flexibility, within the parameters outlined in Unit IV.A.1., regarding 
the manner in which they prevent exceedances of the identified exposure 
thresholds. Therefore, EPA generally refers to the WCPP approach as a 
non-prescriptive approach. In the case of methylene chloride, meeting 
the exposure thresholds proposed by EPA for certain occupational 
conditions of use would address unreasonable risk driven by inhalation 
exposure from those conditions of use for potentially exposed persons.
    EPA's proposed requirements include the specific exposure limits 
that would be required to meet the TSCA section 6(a) standard to apply 
one or more requirements to the substance so that it no longer presents 
unreasonable risk, and also include ancillary requirements necessary 
for the ECEL's successful implementation as part of a WCPP.
    EPA is not proposing reporting requirements beyond downstream 
notification (third-party notifications). Regarding recordkeeping 
requirements, three primary provisions of the proposed rule relate to 
recordkeeping. The first is recordkeeping for PPE: under the proposed 
regulatory action, facilities complying with the rule through WCPP 
would be required to develop and maintain records associated with a 
dermal and inhalation protection and in accordance with an exposure 
control plan. Additionally, under the proposed regulatory action, 
facilities complying with the rule through a WCPP would be required to 
monitor exposure levels and maintain records of this monitoring. Last, 
under the proposed regulatory action, facilities complying with the 
rule through a WCPP would be required to notify potentially exposed 
persons of monitoring results.
a. Classes of Small Entities Subject to the Compliance Requirements
    The small entities that would be potentially directly regulated by 
this rule are small businesses that manufacture (including import), 
process, distribute in commerce, use, or dispose of methylene chloride, 
including retailers of methylene chloride for end-consumer uses.
b. Professional Skills Needed To Comply
    Entities that would be subject to this proposal that manufacture 
(including import), process, or distribute methylene chloride in 
commerce for consumer use would be required to cease under the proposed 
rule. The entity would be required to modify their Safety Data Sheet or 
develop another way to inform their customers of the prohibition on 
manufacture, processing, and distribution of methylene chloride for 
consumer use. They would also be required to keep records of how much 
methylene chloride they sold, and to whom, and maintain a copy of the 
method they use for notifying their customers. None of these activities 
require any special skills.
    Entities that use methylene chloride in any of the industrial and 
commercial conditions of use that are prohibited would be required to 
cease under the proposed rule. Restriction or prohibition of these uses 
will likely require the implementation of an alternative chemical or 
the cessation of use of methylene chloride in a process or equipment 
that may require persons

[[Page 28338]]

with specialized skills, such as engineers or other technical experts. 
Instead of developing an alternative method themselves, commercial 
users of methylene chloride may choose to contract with another entity 
to do so.
    Entities that would be permitted to continue to manufacture, 
process, distribute, use, or dispose of methylene chloride would be 
required to implement a WCPP and would have to meet the provisions of 
the program for continued use of methylene chloride. Adaption to a WCPP 
may require persons with specialized skills such as an engineer or 
health and safety professional. Instead of implementing the WCPP 
themselves, entities that use methylene chloride may choose to contract 
with another entity to do so. Records would have to be maintained for 
compliance with a WCPP. While this recording activity itself may not 
require a special skill, the information to be measured and recorded 
may require persons with specialized skills such as an industrial 
hygienist.
5. Relevant Federal Rules
    Because of its health effects, methylene chloride is subject to 
numerous State, Federal, and international regulations restricting and 
regulating its use. The following is a summary of the regulatory 
actions pertaining to methylene chloride; for a full description see 
appendix A of the 2020 Risk Evaluation for Methylene Chloride.
    EPA has issued numerous rules and notices pertaining to methylene 
chloride under its various authorities. Methylene chloride is a 
hazardous air pollutant (HAP) under the CAA (42 U.S.C. 7412(b)(1)). EPA 
promulgated National Emission Standards for Hazardous Air Pollutants 
(NESHAPs) for methylene chloride for several industrial source 
categories.
    With this proposed rule under TSCA section 6, certain uses 
identified under these NESHAPs would be prohibited while other uses 
would be subject to a WCPP. Moreover, the proposed rule would allow 
methylene chloride's continued use in processing as a reactant for the 
manufacture of HFC-32 and subject to compliance as part of a WCPP.
    Programs within EPA implementing other environmental statutes, 
including, but not limited to, the RCRA, the Comprehensive 
Environmental Response, the Compensation, and Liability Act (CERCLA), 
the SDWA, and the CWA, classify methylene chloride as a hazardous 
waste, a hazardous substance, a volatile organic contaminant, and a 
toxic pollutant, respectively. Releases into the environment of 
methylene chloride in excess of 1,000 pounds must be reported under 
CERCLA (40 CFR 302.4). While TSCA shares equity in the regulation of 
methylene chloride, EPA does not anticipate this rule to duplicate nor 
conflict with the aforementioned programs' classifications and 
associated rules.
    In addition to regulations administered by the EPA, methylene 
chloride is also subject to regulations by other Federal agencies.
    In 2005, the Secretary of Transportation listed methylene chloride 
as a hazardous material with regard to transportation that is subject 
to regulations prescribing requirements applicable to the shipment and 
transportation of listed hazardous materials under the Hazardous 
Materials Transportation Act (70 FR 34381, June 14, 2005).
    OSHA has a standard for regulating methylene chloride under 29 CFR 
1910.1052. The OSHA PEL, action level, STEL, and ancillary requirements 
have established a strong precedent for exposure threshold requirements 
within the regulated community. However, EPA recognizes that the 
existing PEL and STEL do not eliminate the unreasonable risk identified 
by EPA under TSCA, and EPA is therefore proposing to apply new, lower 
exposure thresholds, derived from the 2020 Risk Evaluation for 
Methylene Chloride, while aligning with existing requirements wherever 
possible. For methylene chloride, this approach would eliminate the 
unreasonable risk driven by certain conditions of use, reduce burden 
for complying with the regulations, and provide the familiarity of a 
pre-existing framework for the regulated community.
    Under the FHSA enforced by CPSC, household products are required to 
have hazardous substance labels for products that contain methylene 
chloride. In 1987, CPSC issued a decision to require labeling of 
household products that contain methylene chloride under the FHSA (52 
FR 34698, September 14, 1987). Labels indicated that inhalation of 
methylene chloride vapor has caused cancer in certain laboratory 
animals, and the labels specified precautions to be taken during use by 
consumers. In 2018, in response to a petition, CPSC updated the 
labeling policy for paint strippers containing methylene chloride to 
include a warning of the acute hazards from inhalation of methylene 
chloride vapors in addition to the chronic hazards (83 FR 12254, March 
21, 2018, and 83 FR 18219, April 26, 2018). With the proposed 
prohibition on the manufacture, processing, and distribution in 
commerce of methylene chloride for paint and coating removal under 
TSCA, EPA anticipates that CPSC may require labeling for any products 
that fall outside of the scope of TSCA and would not present conflict.
    In pesticides, methylene chloride was registered as an 
antimicrobial pesticide in 1974 pursuant to the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.). 
Methylene chloride was also a pesticide product inert ingredient used 
as a solvent and co-solvent, and as a dispersing and wetting agent. In 
June 1998, EPA published a Federal Register document that designated 
methylene chloride as a List 1 inert ingredient due to its 
toxicological and other concerning effects (63 FR 34384, June 24, 1998) 
(FRL-5792-3). In 2002, EPA revoked pesticide tolerance exemptions for 
methylene chloride as an extraction solvent and as a post-harvest 
fumigant for crops established under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) (67 FR 16027, April 4, 2002) (FRL-6833-3).
    In 1989, the Food and Drug Administration (FDA) banned methylene 
chloride as an ingredient in all cosmetic products because of its 
animal carcinogenicity and likely hazard to human health under the 
FFDCA (54 FR 27328, June 29, 1989). Before 1989, methylene chloride had 
been used in aerosol cosmetic products, such as hairspray (Ref. 61).
6. Significant Alternatives to the Proposed Rule
    As discussed further in Unit V.A.4. and the IRFA, EPA considered--
in addition to the prohibition and WCPP that are proposed--a wide 
variety of control measures to address the unreasonable risk from 
methylene chloride such as weight fractions, prescriptive controls, and 
a certification and limited access program. The Agency determined that 
some methods either did not effectively address the unreasonable risk 
presented by methylene chloride or there was uncertainty in conditions 
of use that would be less able to comply with a comprehensive WCPP to 
adequately protect potentially exposed persons. The primary alternative 
regulatory action was considered and found to provide greater 
uncertainty in addressing the unreasonable risk from methylene chloride 
under the conditions of use.
    As required by the RFA section 609(b), EPA also convened a SBAR 
Panel to obtain advice and recommendations from small entity

[[Page 28339]]

representatives that potentially would be subject to the rule's 
requirements. The SBAR Panel evaluated the assembled materials and 
small-entity comments on issues related to elements of an IRFA. The 
panel recommended EPA include certain requests for comment, which can 
be found in Unit VIII. (number 3.a through 3.k) and summarized in the 
Initial Regulatory Flexibility Assessment (Ref. 27). The full SBAR 
Panel Report is in the rulemaking docket (Ref. 6).

D. Unfunded Mandates Reform Act (UMRA)

    This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for 
State, local and Tribal governments, in the aggregate, or the private 
sector in any one year. Accordingly, the EPA has prepared a written 
statement required under UMRA section 202. The statement is included in 
the docket for this action and briefly summarized here.
    EPA estimates the compliance costs of the proposed rule to the 
private sector to be approximately to be $13.2 million annualized over 
20 years at a 3% discount rate and $14.5 million annualized over 20 
years at a 7% discount rate. However, the costs of the rule to the 
private sector are difficult to completely quantify. EPA's upper-bound 
estimate for the potential economic impact of the proposed rule on 
firms subject to the proposed prohibition on the use of methylene 
chloride in commercial furniture refinishing involves a worst-case 
assumption that all of as many as 5,000 furniture refinishing firms 
will fully close due to the proposed prohibition.
    As described in more detail in Units I.E. VI.D.2. and Tables 3-1 
and 6-12 of the Economic Analysis (Ref. 3), EPA estimates the upper-
bound economic impact of potential closures of affected furniture 
refinishing firms using methylene chloride following this rulemaking to 
be $1.8 billion in total lost revenue, and $67 million in terms of the 
total lost profit, under the assumption that all affected firms fully 
close due to the proposed restrictions on methylene chloride. Thus, the 
Agency concludes that cost of the rule to the private sector may exceed 
the inflation-adjusted UMRA threshold of $100 million in any one year.
    Nevertheless, the economic impact of a regulation on the national 
economy is generally considered to be measurable only if the economic 
impact of the regulation reaches 0.25 percent to 0.5 percent of GDP 
(Ref. 58). Given the current GDP of $23.17 trillion, this is equivalent 
to a cost of $58 billion to $116 billion. Therefore, EPA has concluded 
that this rule is highly unlikely to have any measurable effect on the 
national economy. Additional information on EPA's estimates of the 
benefits and costs of this action are provided in Units I.E. and 
VI.D.2., and in the Economic Analysis for this action (Ref. 3). 
Information on the authorizing legislation is provided in Unit I.B. 
Information on prior consultations with affected State, local, and 
Tribal governments is provided in Unit III.A.1.
    This action is not subject to the requirements of UMRA section 203 
because it contains no regulatory requirements that might significantly 
or uniquely affect small governments.

E. Executive Order 13132: Federalism

    EPA has concluded that this action has federalism implications, as 
specified in Executive Order 13132 (64 FR 43255, August 10, 1999), 
because regulation under TSCA section 6(a) may preempt State law. As 
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA 
section 6(a) to address the unreasonable risks presented by a chemical 
substance has the potential to trigger preemption of laws, criminal 
penalties, or administrative actions by a State or political 
subdivision of a State that are: (1) Applicable to the same chemical 
substance as the rule under TSCA section 6(a); and (2) Designed to 
prohibit or otherwise restrict the manufacture, processing, or 
distribution in commerce or use of that same chemical. TSCA section 
18(c)(3) applies that preemption only to the ``hazards, exposures, 
risks, and uses or conditions of use'' of such chemical included in the 
final TSCA section 6(a) rule.
    EPA provides the following preliminary federalism summary impact 
statement. The Agency consulted with State and local officials early in 
the process of developing the proposed action to permit them to have 
meaningful and timely input into its development. This included a 
consultation meeting on October 22, 2020, and a background presentation 
on September 9, 2020. EPA invited the following national organizations 
representing State and local elected officials to these meetings: 
Association of State Drinking Water Administrators, National 
Association of Clean Water Agencies, Western States Water Council, 
National Water Resources Association, American Water Works Association, 
Association of Metropolitan Water Agencies, Association of Clean Water 
Administrators, Environmental Council of the States, National 
Association of Counties, National League of Cities, County Executives 
of America, U.S. Conference of Mayors, and National Association of 
Attorneys General. A summary of the meeting with these organizations, 
including the views that they expressed, is available in the docket 
(Ref. 22). As discussed in Unit III.A.1., during Federal consultation 
meetings EPA provided information on TSCA section 6 regulations and 
participants discussed preemption as well as the relationship between 
TSCA and existing statutes such as the CWA and SDWA. (Ref. 22). EPA 
provided an opportunity for these organizations to provide follow-up 
comments in writing but did not receive any such comments.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will 
not have substantial direct effects on Tribal governments, on the 
relationship between the Federal Government and the Indian Tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. Methylene chloride is not manufactured, 
processed, or distributed in commerce by Tribes and, therefore, this 
rulemaking would not impose substantial direct compliance costs on 
Tribal governments. Thus, Executive Order 13175 does not apply to this 
action.
    Consistent with the EPA Policy on Consultation and Coordination 
with Indian Tribes, EPA consulted with Tribal officials during the 
development of this action. The Agency held a Tribal consultation from 
October 7, 2020, to January 8, 2021, with meetings on November 12 and 
13, 2020. Tribal officials were given the opportunity to meaningfully 
interact with EPA concerning the current status of risk management. 
During the consultation, EPA discussed risk management under TSCA 
section 6(a), findings from the 2020 Risk Evaluation for Methylene 
Chloride, types of information to inform risk management, principles 
for transparency during risk management, and types of information EPA 
sought from Tribal officials (Ref. 23). EPA briefed Tribal officials on 
the Agency's risk management considerations and Tribal officials raised 
no related issues or concerns to EPA during or in follow-up to those 
meetings (Ref. 23). EPA received no written comments as part of this 
consultation.

[[Page 28340]]

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because EPA does not believe the environmental health 
or safety risks addressed by this action present a disproportionate 
risk to children as reflected by the conclusions of the methylene 
chloride risk evaluation. Accordingly, this action's health and risk 
assessments are contained in Units III.A.3., III.B.2., and V.A., as 
well as in the 2020 Risk Evaluation for Methylene Chloride, and the 
Economic Analysis for this proposed rulemaking (Refs. 1, 3).

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' under Executive 
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to 
have a significant adverse effect on the supply, distribution or use of 
energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has 
determined that this rulemaking involves environmental monitoring or 
measurement, specifically for occupational inhalation exposures to 
methylene chloride. Consistent with the Agency's Performance Based 
Measurement System (PBMS), EPA proposes not to require the use of 
specific, prescribed analytic methods. Rather, the Agency plans to 
allow the use of any method that meets the prescribed performance 
criteria. The PBMS approach is intended to be more flexible and cost-
effective for the regulated community; it is also intended to encourage 
innovation in analytical technology and improved data quality. EPA is 
not precluding the use of any method, whether it constitutes a 
voluntary consensus standard or not, as long as it meets the 
performance criteria specified.
    For this rulemaking, the key consideration for the PBMS approach is 
the ability to accurately detect and measure airborne concentrations of 
methylene chloride at the ECEL, the ECEL action level, and the EPA 
STEL. Some examples of methods which meet the criteria are included in 
appendix A of the ECEL memo (Ref. 11). EPA recognizes that there may be 
voluntary consensus standards that meet the proposed criteria (Ref. 
62). EPA requests comments on whether it should incorporate such 
voluntary consensus standards in the rule and seeks information in 
support of such comments regarding the availability and applicability 
of voluntary consensus standards that may achieve the sampling and 
analytical requirements of the rule in lieu of the PBMS approach.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
Federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or Indigenous 
peoples) and low-income populations.
    EPA believes that the human health and environmental conditions 
that exist prior to this action do not result in disproportionate and 
adverse effects on people of color, low-income populations, and/or 
Indigenous peoples. The documentation for this decision is contained in 
the Economic Analysis (Ref. 3), which is in the public docket for this 
action. As part of the Economic Analysis for this rulemaking, EPA 
conducted an environmental justice analysis using information about the 
facilities, workforce, and communities potentially affected by the 
regulatory options under current conditions, before the proposed 
regulation would goes into effect. The analysis drew on publicly 
available data provided by EPA, U.S. Census Bureau, and Centers for 
Disease Control and Prevention (CDC), including data from TRI, EPA 
Enforcement and Compliance History Online (ECHO), National Air Toxics 
Assessment (NATA), the American Community Survey, and the Behavioral 
Risk Factor Surveillance System. The intent of the analysis was to 
characterize the baseline conditions faced by communities and workers 
to identify the potential for disproportionate impacts on minority and 
low-income populations.
    EPA believes that this action is not likely to result in new 
disproportionate and adverse effects on people of color, low-income 
populations and/or Indigenous peoples. However, while this regulatory 
action would apply requirements to the extent necessary so that 
methylene chloride no longer presents an unreasonable risk, EPA is not 
able to quantify the distribution of the change in risk across affected 
workers, communities, or demographic groups due to data limitations 
that prevented EPA from conducting a more comprehensive analysis of 
such a change.
    EPA additionally identified and addressed environmental justice 
concerns by conducting outreach to advocates of communities that might 
be subject to disproportionate exposure to methylene chloride, such as 
minority populations, low-income populations, and Indigenous peoples.
    On November 16 and 19, 2020, EPA held public meetings as part of 
this consultation. (Ref. 51). See also Unit III.A.1. These meetings 
were held pursuant to and in compliance with Executive Order 12898 and 
Executive Order 14008, Tackling the Climate Crisis at Home and Abroad 
(86 FR 7619, February 1, 2021). EPA received three written comments 
following the EJ meetings, in addition to oral comments provided during 
the consultations (Refs. 24, 25, 26). In general, commenters supported 
strong regulation of methylene chloride to protect lower-income 
communities and workers. Commenters supported strong outreach to 
affected communities, encouraged EPA to follow the hierarchy of 
controls, favored prohibitions, and noted the uncertainty of use--and 
in some cases inadequacy--of PPE.
    The information supporting this Executive Order review is contained 
in Units II.D., III.A.1., and VI.A., and well as in the Economic 
Analysis (Ref. 3, 51). EPA's presentations, a summary of EPA's 
presentation and public comments made, and fact sheets for the 
environmental justice consultations related to this rulemaking are 
available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/environmental-justice-consultations-methylene-chloride. 
These materials are also available in the public docket for this 
rulemaking.

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export notification, Hazardous 
substances, Import certification, Reporting and recordkeeping.

Michael S. Regan,
Administrator.

    Therefore, for the reasons stated in the preamble, EPA proposes to 
amend 40 CFR chapter I as follows:

[[Page 28341]]

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority: 15 U.S.C. 2605.

0
2. Amend Sec.  751.5 by adding in alphabetical order definitions for 
``authorized person'', ``ECEL'', ``EPA STEL'', ``owner or operator'', 
``potentially exposed person'', ``regulated area'', and ``retailer'' to 
read as follows:


Sec.  751.5  Definitions

* * * * *
    Authorized person means any person specifically authorized by the 
owner or operator to enter, and whose duties require the person to 
enter, a regulated area.
* * * * *
    ECEL is an Existing Chemical Exposure Limit, which is an EPA 
regulatory limit on workplace exposure to an airborne concentration of 
a chemical substance, generally based on an eight (8)-hour time-
weighted average (TWA).
* * * * *
    EPA STEL is a Short-Term Exposure Limit, which is an EPA regulatory 
limit on workplace exposure to an airborne concentration of a chemical 
substance, based on an exposure of less than eight hours.
    Owner or operator means any person who owns, leases, operates, 
controls, or supervises a workplace covered by this part.
* * * * *
    Potentially exposed person means any person who may be 
occupationally exposed to a chemical substance or mixture in a 
workplace as a result of a condition of use of that chemical substance 
or mixture.
    Regulated area means an area established by the regulated entity to 
demarcate areas where airborne concentrations of a specific chemical 
substance exceed, or there is a reasonable possibility they may exceed, 
the ECEL or the EPA STEL.
    Retailer means a person who distributes in commerce or makes 
available a chemical substance or mixture to consumer end users, 
including e-commerce internet sales or distribution. Any distributor 
with at least one consumer end user customer is considered a retailer. 
A person who distributes in commerce or makes available a chemical 
substance or mixture solely to commercial or industrial end users or 
solely to commercial or industrial businesses is not considered a 
retailer.
0
3. Revise Sec.  751.101 to read as follows:


Sec.  751.101  General.

    This subpart sets certain restrictions on the manufacture 
(including import), processing, distribution in commerce, use, and 
disposal of methylene chloride (CASRN 75-09-2) to prevent unreasonable 
risks of injury to health.
0
4. Amend Sec.  751.103 by adding in alphabetical order a definition for 
``ECEL'' to read as follows:


Sec.  751.103  Definitions.

* * * * *
    ECEL action level means a concentration of airborne methylene 
chloride of 1 part per million (1 ppm) calculated as an 8-hour time 
weighted average (TWA).
* * * * *
0
5. Amend Sec.  751.105 by revising the section heading to read as 
follows:


Sec.  751.105  Prohibition of manufacturing (including import), 
processing, and distribution in commerce related to consumer paint and 
coating removal.

* * * * *


Sec.  751.107  [Redesignated as Sec.  751.111]

0
6. Redesignate Sec.  751.107 as Sec.  751.111 in subpart B and add new 
Sec.  751.107 in subpart B to read as follows:


Sec.  751.107  Other prohibitions of manufacturing (including import), 
processing, distribution in commerce, and use.

    (a) Applicability. (1) The provisions of this section apply to all 
manufacturing (including import)),), processing, and distribution in 
commerce of methylene chloride for consumer use other than for the 
paint and coating removal use addressed under Sec.  751.105.
    (2) The provisions of this section apply to all manufacturing 
(including import), processing, and distribution in commerce of 
methylene chloride for industrial or commercial use, and to all 
commercial or industrial use of methylene chloride, other than the 
conditions of use addressed under Sec.  751.109(a).
    (b) Prohibitions. (1) After [DATE 90 DAYS AFTER DATE OF PUBLICATION 
OF FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from 
manufacturing (including import) methylene chloride, for the uses 
listed in paragraphs (a)(1) and (2) of this section except for those 
uses specified in paragraph (b)(7) of this section.
    (2) After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all persons are prohibited from processing 
methylene chloride, including any methylene chloride-containing 
products for the uses listed in paragraphs (a)(1) and (2) of this 
section except for those uses specified in paragraph (b)(7) of this 
section.
    (3) After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all persons are prohibited from distributing in 
commerce methylene chloride, including any methylene chloride-
containing products, to retailers for any use.
    (4) After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all retailers are prohibited from distributing 
in commerce (including making available) methylene chloride, including 
any methylene chloride-containing products, for any use.
    (5) After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all persons are prohibited from distributing in 
commerce (including making available) methylene chloride, including any 
methylene chloride-containing products for any use described in 
paragraphs (a)(1) and (2) of this section except for those uses 
specified in paragraph (b)(7) of this section.
    (6) After [DATE 450 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all persons are prohibited from industrial or 
commercial use of methylene chloride, including any methylene chloride 
containing products for the uses listed in paragraph (a)(2) of this 
section except for those uses specified in paragraph (b)(7) of this 
section.
    (7) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN 
THE FEDERAL REGISTER], all persons are prohibited from manufacturing 
(including import), processing, distribution in commerce, or use of 
methylene chloride, including any methylene chloride containing 
products, for industrial or commercial use for paint or coating removal 
from safety critical, corrosion-sensitive components of aircraft or 
spacecraft as described in Sec.  751.115(b)(1) through (3).


Sec.  751.109  [Redesignated as Sec.  751.113]

0
7. Redesignate Sec.  751.109 as new Sec.  751.113 in subpart B and add 
new Sec.  751.109 in subpart B to read as follows:


Sec.  751.109  Workplace Chemical Protection Program.

    (a) Applicability. The provisions of this section apply to the 
following

[[Page 28342]]

conditions of use of methylene chloride, except to the extent the 
conditions of use are prohibited by Sec. Sec.  751.105 and 751.107:
    (1) Manufacturing (domestic manufacture);
    (2) Manufacturing (import);
    (3) Processing: as a reactant;
    (4) Processing: incorporation into a formulation, mixture, or 
reaction product;
    (5) Processing: repackaging;
    (6) Processing: recycling;
    (7) Industrial and commercial use as a laboratory chemical;
    (8) Industrial or commercial use for paint and coating removal from 
safety-critical, corrosion-sensitive components of aircraft and 
spacecraft that are owned or operated by the U.S. Department of 
Defense, the National Aeronautics and Space Administration, the U.S. 
Department of Homeland Security, and the Federal Aviation 
Administration that is performed by the agency or the agency's 
contractor at locations controlled by the agency or the agency's 
contractor.
    (9) Industrial or commercial use as a bonding agent for acrylic and 
polycarbonate in mission-critical military and space vehicle 
applications, including in the production of specialty batteries for 
applications that are performed by the U.S. Department of Defense, the 
National Aeronautics and Space Administration, or the U.S. Department 
of Homeland Security or their contractors at locations controlled by 
the agency or the agency's contractor; and
    (10) Disposal;
    (b) Relationship to 29 CFR part 1910. For purposes of this section:
    (1) Any provisions applying to ``employee'' in 29 CFR 1910.1020, 29 
CFR 1910.132, 29 CFR 1910.134, and 29 CFR 1910.1052 also apply equally 
to potentially exposed persons; and
    (2) Any provisions applying to ``employer'' in 29 CFR 1910.1020, 29 
CFR 1910.132, 29 CFR 1910.134, and 29 CFR 1910.1052 also apply equally 
to any owner or operator for the regulated area.
    (c) Exposure limits. The owner or operator must ensure the 
following:
    (1) Existing Chemical Exposure Limit (ECEL). No person is exposed 
to an airborne concentration of methylene chloride in excess of 2 parts 
of methylene chloride per million parts of air (2 ppm) as an 8-hour 
TWA.
    (2) EPA short-term exposure limit (EPA STEL). No person is exposed 
to an airborne concentration of methylene chloride in excess of 16 
parts of methylene chloride per million parts of air (16 ppm) as 
determined over a sampling period of 15 minutes.
    (3) Regulated areas. Owners or operators must establish and 
maintain regulated areas in accordance with 29 CFR 1910.1052(e)(2), 
(4), (5), (6), and (7), within 3 months after receipt of the results of 
any monitoring data as outlined in paragraph (d) of this section. 
Owners or operators must establish a regulated area wherever a 
potentially exposed person's exposure to airborne concentrations of 
methylene chloride exceeds or can reasonably be expected to exceed 
either the ECEL or EPA STEL.
    (d) Exposure monitoring--(1) In general--(i) Characterization of 
exposures. Owners or operators must determine each potentially exposed 
person's exposure by either:
    (A) Taking a personal breathing zone air sample of each potentially 
exposed person's exposure; or
    (B) Taking personal breathing zone air samples that are 
representative of each potentially exposed person's exposure.
    (ii) Representative samples. Owners or operators are permitted to 
consider personal breathing zone air samples to be representative of 
each potentially exposed person's exposure when they are taken as 
follows:
    (A) ECEL. The owner or operator has taken one or more personal 
breathing zone air samples for at least one potentially exposed person 
in each job classification in a work area during every work shift, and 
the person sampled is expected to have the highest methylene chloride 
exposure.
    (B) EPA STEL. The owner or operator has taken one or more personal 
breathing zone air samples which indicate the highest likely 15-minute 
exposures during such operations for at least one potentially exposed 
person in each job classification in the work area during every work 
shift, and the person sampled is expected to have the highest methylene 
chloride exposure.
    (C) Exception. Personal breathing zone air samples taken during one 
work shift may be used to represent potentially exposed person 
exposures on other work shifts where the owner or operator can document 
that the tasks performed and conditions in the workplace are similar 
across shifts.
    (iii) Accuracy of monitoring. Owners or operators must ensure that 
the methods used to perform exposure monitoring produce results that 
are accurate to a confidence level of 95%, and are:
    (A) Within plus or minus 25% for airborne concentrations of 
methylene chloride above the ECEL or the EPA STEL; or
    (B) Within plus or minus 35% for airborne concentrations of 
methylene chloride at or above the ECEL action level but at or below 
the ECEL.
    (iv) Currency of monitoring data. Owners or operators are not 
permitted to rely on monitoring data that is more than 5 years old to 
demonstrate compliance with initial or periodic monitoring requirements 
for either the ECEL or the EPA STEL.
    (2) Initial monitoring. (i) After [DATE 180 DAYS AFTER DATE OF 
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] each owner or 
operator of a workplace where methylene chloride is present must 
perform an initial exposure monitoring to determine each potentially 
exposed person's exposure, except under the following temporary 
conditions:
    (A) An owner or operator can provide EPA with objective data 
generated during the last 5 years that demonstrates to EPA that 
methylene chloride cannot be released in the workplace in airborne 
concentrations at or above the ECEL action level (1-ppm 8-hour TWA) or 
above the EPA STEL (16 ppm 15-minute TWA) and that the data represents 
the highest methylene chloride exposures likely to occur under 
conditions of use described in paragraph (a) of this section; or
    (B) Where potentially exposed persons are exposed to methylene 
chloride for fewer than 30 days per year, and the owner or operator has 
measurements by direct-metering devices which give immediate results 
and which provide sufficient information regarding exposures to 
determine and implement the control measures that are necessary to 
reduce exposures to below the ECEL action level and EPA STEL.
    (ii) An owner or operator must re-conduct an initial exposure 
monitoring at least once every 5 years if methylene chloride is present 
in the workplace.
    (3) Periodic monitoring. Where the initial exposure monitoring 
shows exposure at or above the ECEL action level at or above the EPA 
STEL, the owner or operator must establish an exposure monitoring 
program for periodic monitoring of exposure to methylene chloride in 
accordance with table 1 to this paragraph (d)(3).

[[Page 28343]]



 Table 1 to Sec.   751.109(d)(3)--Periodic Monitoring Requirements Based
                 on Initial Exposure Monitoring Results
------------------------------------------------------------------------
  Air concentration condition observed
   during initial exposure monitoring    Periodic monitoring requirement
------------------------------------------------------------------------
If the initial exposure monitoring       ECEL and EPA STEL monitoring
 concentration is below the ECEL action   not required.
 level and at or below the EPA STEL.
If the initial exposure monitoring       ECEL monitoring not required,
 concentration is below the ECEL action   and EPA STEL monitoring
 level and above the EPA STEL.            required every 3 months.
If the initial exposure monitoring       ECEL monitoring every 6 months.
 concentration is at or above the ECEL
 action level and at or below the ECEL;
 and at or below the EPA STEL.
If the initial exposure monitoring       ECEL monitoring every 6 months
 concentration is at or above the ECEL    and EPA STEL monitoring every
 action level and at or below the ECEL;   3 months.
 and above the EPA STEL.
If the initial exposure monitoring       ECEL monitoring every 3 months
 concentration is above the ECEL and      and EPA STEL monitoring every
 below, at, or above the EPA STEL.        3 months.
Two consecutive monitoring events have   Reduce ECEL periodic monitoring
 taken place 7 days apart that indicate   frequency from every 3 months
 that potential exposure has decreased    to every 6 months.
 from above the ECEL to at or below the
 ECEL, but at or above the ECEL action
 level.
Two consecutive monitoring events have   Transition from ECEL periodic
 taken place 7 days apart that indicate   monitoring frequency from of
 that potential exposure has decreased    every 6 months to initial
 to below the ECEL action level and at    monitoring once every 5 years.
 or below the EPA STEL.                   The second consecutive
                                          monitoring event will
                                          delineate the new date from
                                          which the next 5-year initial
                                          exposure monitoring must
                                          occur.
If the owner or operator engages in any  The owner or operator may forgo
 conditions of use described in           the upcoming periodic
 paragraph (a) of this section and is     monitoring event. However,
 required to monitor either the ECEL or   documentation of cessation of
 EPA STEL in a 3-month interval, but      use of methylene chloride must
 does not engage in any of those uses     be maintained, and initial
 for the entirety of the 3-month          monitoring is required when
 interval.                                the owner or operator resumes
                                          or starts any of the
                                          conditions of use described in
                                          paragraph (a) of this section.
Owner or operator engages in any         The owner or operator may forgo
 conditions of use described in           the upcoming periodic
 paragraph (a) of this section and is     monitoring event. However,
 required to monitor the ECEL in a 6-     documentation of cessation of
 month interval, but does not engage in   the condition(s) of use must
 any of those uses for the entirety of    be maintained until periodic
 the 6-month interval..                   monitoring resumes, and
                                          initial monitoring is required
                                          when the owner or operator
                                          resumes or starts any of the
                                          conditions of use described in
                                          paragraph (a) of this section.
------------------------------------------------------------------------
Note: Additional scenarios in which monitoring may be required are
  discussed paragraph (d)(4).

    (4) Additional monitoring. The owner or operator must conduct an 
additional initial exposure monitoring immediately after any change 
that may reasonably be expected to introduce additional sources of 
exposure to methylene chloride, or otherwise result in increased 
exposure to methylene chloride compared to the most recent monitoring 
event.
    (5) Notification of monitoring results. (i) The owner or operator 
must inform potentially exposed persons of monitoring results within 15 
working days.
    (ii) This notification must include the following:
    (A) Exposure monitoring results;
    (B) Identification and explanation of the ECEL, ECEL Action Level, 
and EPA STEL in plain language;
    (C) Explanation of any corresponding required respiratory 
protection as described in paragraph (f);
    (D) Descriptions of actions taken by the owner or operator to 
reduce exposure;
    (E) Quantity of methylene chloride in use;
    (F) Location of methylene chloride use;
    (G) Manner of methylene chloride use;
    (H) Identified releases of methylene chloride; and
    (I) Whether the airborne concentration of methylene chloride 
exceeds the ECEL or the EPA STEL.
    (iii) Notice must be provided in plain language writing, in a 
language that the person understands, to each potentially exposed 
person or posted in an appropriate and accessible location outside the 
regulated area with an English-language version and a non-English 
language version representing the language of the largest group of 
workers who do not read English.
    (e) ECEL control procedures and plan--(1) Method of compliance. 
After [DATE 360 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE 
FEDERAL REGISTER], the owner or operator must institute and maintain 
the effectiveness of engineering controls and work practices to reduce 
exposure to or below the ECEL and EPA STEL except to the extent that 
the owner or operator can demonstrate that such controls are not 
feasible. Wherever the feasible engineering controls and work practices 
which can be instituted are not sufficient to reduce exposures for 
potentially exposed person to or below the ECEL or EPA STEL, the owner 
or operator must use them to reduce exposure to the lowest levels 
achievable by these controls and must supplement them by the use of 
respiratory protection that complies with the requirements of paragraph 
(f) of this section to reduce exposures to or below the ECEL or EPA 
STEL. Wherever engineering controls and work practices are not 
feasible, the owner or operator must use respiratory protection that 
complies with the requirements of paragraph (f) of this section to 
reduce exposures for potentially exposed persons to or below the ECEL 
or EPA STEL. Where an owner or operator cannot demonstrate the use of 
engineering controls or work practices that result in exposure below 
the ECEL or EPA STEL, and has not demonstrated that it has supplemented 
the risk of exposure with respiratory protection, this will constitute 
a failure to comply with the ECEL. Additionally, the owner or operator 
must not implement a schedule of personnel rotation as a means of 
compliance with the ECEL.
    (2) Exposure control plan requirements. After [DATE 360 DAYS AFTER 
DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER], the owner 
or operator must include and document in an exposure control plan the 
following:
    (i) Identification of exposure controls and rationale for using or 
not using exposure controls in the following sequence--elimination, 
substitution,

[[Page 28344]]

engineering controls, and administrative controls--to reduce exposures 
in the workplace to either at or below the ECEL or EPA STEL or to the 
lowest level achievable, and the exposure controls selected based on 
feasibility, effectiveness, and other relevant considerations;
    (ii) If exposure controls were not selected, document the efforts 
identifying why these are not feasible, not effective, or otherwise not 
implemented;
    (iii) Actions taken to implement exposure controls selected, 
including proper installation, maintenance, training or other steps 
taken;
    (iv) Regular inspections, evaluations, and updating of the exposure 
controls to ensure effectiveness and confirmation that all persons are 
using them accordingly;
    (v) Occurrence and duration of any start-up, shutdown, or 
malfunction of exposure controls or of facility equipment that causes 
air concentrations to be above the ECEL or EPA STEL and subsequent 
corrective actions taken during start-up, shutdown, or malfunctions to 
mitigate exposures to methylene chloride; and
    (vi) Objective data generated during the previous 5 years, when 
used to forgo the initial exposure monitoring, must include: the use of 
methylene chloride being evaluated, the source of objective data, 
measurement methods, measurement results, and measurement analysis of 
the use of methylene chloride, and any other relevant data to the 
operations, processes, or person's exposure.
    (3) Respirator requirements. The owner or operator must supply a 
respirator, selected in accordance with paragraph (f) of this section, 
to each potentially exposed person who enters a regulated area and must 
ensure each potentially exposed person uses that respirator whenever 
methylene chloride exposures may exceed the ECEL or EPA STEL.
    (f) Respiratory protection--(1) Respirator conditions. After [DATE 
270 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL 
REGISTER] or within 3 months after receipt of the results of any 
exposure monitoring as described in paragraph (d) of this section, 
owners or operators must provide respiratory protection to all 
potentially exposed persons in the regulated area as outlined in 
paragraph (c)(3) of this section, and according to the provisions 
outlined in 29 CFR 1910.134(a) through (l) (except paragraph 
(d)(1)(iii)) and as specified in this paragraph for potentially exposed 
persons exposed to methylene chloride in concentrations above the ECEL 
or the EPA STEL. For the purpose of this paragraph (f), the maximum use 
concentration (MUC) as used in 29 CFR 1910.134 must be calculated by 
multiplying the assigned protection factor (APF) specified for a 
respirator by the ECEL or EPA STEL.
    (2) Respirator selection criteria. The type of respiratory 
protection that regulated entities must select and provide to 
potentially exposed persons in accordance with 29 CFR 
1910.1052(g)(3)(i), is directly related to the monitoring results, as 
follows:
    (i) If the measured exposure concentration is at or below the ECEL 
or EPA STEL: no respiratory protection is required.
    (ii) If the measured exposure concentration is above 2 ppm and less 
than or equal to 50 ppm: the respirator protection required is any 
NIOSH-certified supplied-air respirator (SAR) or airline respirator in 
a continuous-flow mode equipped with a loose-fitting facepiece or 
helmet/hood (APF 25).
    (iii) If the measured exposure concentration is above 50 ppm and 
less than or equal to 100 ppm the respirator protection required is:
    (A) Any NIOSH-certified Supplied-Air Respirator (SAR) or airline 
respirator in a demand mode equipped with a full facepiece (APF 50); or
    (B) Any NIOSH-certified Self-Contained Breathing Apparatus (SCBA) 
in demand-mode equipped with a full facepiece or helmet/hood (APF 50).
    (iv) If the measured exposure concentration is unknown or at any 
value above 100 ppm and up to 2,000 ppm the respirator protection 
required is:
    (A) Any NIOSH-certified Supplied-Air Respirator (SAR) or airline 
respirator in a continuous-flow mode equipped with a full facepiece or 
certified helmet/hood (APF 1,000); or
    (B) Any NIOSH-certified Supplied-Air Respirator (SAR) or airline 
respirator in pressure-demand or other positive-pressure mode equipped 
with a full facepiece (APF 1,000); or
    (C) Any NIOSH-certified Self-Contained Breathing Apparatus (SCBA) 
in a pressure-demand or other positive-pressure mode equipped with a 
full facepiece or certified helmet/hood (APF 10,000).
    (3) Minimal respiratory protection. Requirements outlined in 
paragraph (e)(2) of this section represent the minimum respiratory 
protection requirements, such that any respirator affording a higher 
degree of protection than the required respirator may be used.
    (4) Workplace participation. Owners or operators must document the 
notice to and ability of any potentially exposed person to access the 
exposure control plan and other associated records.
    (g) Dermal protection. (1) Owners or operators must require the 
donning of gloves that are chemically resistant to methylene chloride 
with activity-specific training where dermal contact with methylene 
chloride is possible, after application of the requirements in 
paragraph (e), in accordance with the NIOSH hierarchy of controls.
    (2) Owners or operators must minimize and protect potentially 
exposed persons from dermal exposure in accordance with 29 CFR 
1910.1052(h) and (i).
    (h) Training. Owners or operators must provide training in 
accordance with 29 CFR 1910.1052(l)(1) through (6) to potentially 
exposed persons prior to or at the time of initial assignment to a job 
involving potential exposure to methylene chloride. In addition, if 
respiratory protection or PPE must be worn within a regulated area, 
owners or operators must provide training in accordance with 29 CFR 
1910.132(f) to potentially exposed persons within that regulated area.
0
8. Revise newly redesignated Sec.  751.111 to read as follows:


Sec.  751.111  Downstream notification.

    (a) After August 26, 2019, and before [DATE 150 DAYS AFTER DATE OF 
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for each person who 
manufactures (including imports), and before [DATE 210 DAYS AFTER DATE 
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER] for each person 
who processes or distributes in commerce, methylene chloride for any 
use must, prior to or concurrent with the shipment, notify companies to 
whom methylene chloride is shipped, in writing, of the restrictions 
described in Sec.  751.105. Notification must occur by inserting the 
following text in section 1(c) and section 15 of the SDS provided with 
the methylene chloride or with any methylene chloride containing 
product:

    This chemical/product is not and cannot be distributed in 
commerce (as defined in TSCA section 3(5)) or processed (as defined 
in TSCA section 3(13)) for consumer paint or coating removal.

    (b) Beginning on [DATE 150 DAYS AFTER DATE OF PUBLICATION OF FINAL 
RULE IN THE FEDERAL REGISTER], each person who manufactures (including 
import) methylene chloride for any use must, prior to or concurrent 
with the shipment, notify companies to whom

[[Page 28345]]

methylene chloride is shipped, in writing, of the restrictions 
described in this subpart in accordance with paragraph (d) of this 
section.
    (c) Beginning on [DATE 210 DAYS AFTER DATE OF PUBLICATION OF FINAL 
RULE IN THE FEDERAL REGISTER], each person who processes or distributes 
in commerce methylene chloride or methylene chloride-containing 
products for any use must, prior to or concurrent with the shipment, 
notify companies to whom methylene chloride is shipped, in writing, of 
the restrictions described in this subpart in accordance with paragraph 
(d) of this section.
    (d) The notification required under paragraphs (b) and (c) of this 
section must occur by inserting the following text in section 1(c) and 
section 15 of the SDS provided with the methylene chloride or with any 
methylene chloride containing product:

    After August 26, 2019, this chemical/product is not and cannot 
be distributed in commerce or processed for consumer paint or 
coating removal. After [DATE 270 DAYS AFTER DATE OF PUBLICATION OF 
FINAL RULE IN THE FEDERAL REGISTER] this chemical/product cannot be 
distributed in commerce to retailers for any use. After [DATE 360 
DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL 
REGISTER], this chemical/product is and can only be processed or 
distributed in commerce for the following purposes: (1) Processing 
as a reactant; (2) Processing for incorporation into a formulation, 
mixture, or reaction product; (3) Processing for repackaging; (4) 
Processing for recycling; (5) Industrial or commercial use as a 
laboratory chemical; (6) Industrial or commercial use as a bonding 
agent for acrylic and polycarbonate in mission-critical military and 
space vehicle applications, including in the production of specialty 
batteries for such applications that are performed by the U.S. 
Department of Defense, the National Aeronautics and Space 
Administration, or the Department of Homeland Security or their 
contractors at locations controlled by the agency or the agency's 
contractor; (7) Industrial or commercial use for paint and coating 
removal from safety-critical, corrosion-sensitive components of 
aircraft and spacecraft that are owned or operated by the U.S. 
Department of Defense, the National Aeronautics and Space 
Administration, the U.S. Department of Homeland Security, and the 
Federal Aviation Administration that is performed by the agency or 
the agency's contractor at locations controlled by the agency or the 
agency's contractor; (8) Industrial or commercial use for paint and 
coating removal from safety critical, corrosion-sensitive components 
of other aircraft or spacecraft until [DATE 10 YEARS AFTER DATE OF 
PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]; and (9) 
Disposal.

0
9. Revise newly redesignated Sec.  751.113 to read as follows:


Sec.  751.113  Recordkeeping Requirements.

    (a) General records. Each person who manufactures (including 
imports), processes, or distributes in commerce any methylene chloride 
after August 26, 2019, must retain in one location at the headquarters 
of the company, or at the facility for which the records were 
generated, documentation showing:
    (1) The name, address, contact, and telephone number of companies 
to whom methylene chloride was shipped;
    (2) A copy of the notification provided under Sec.  751.111; and
    (3) The amount of methylene chloride shipped.
    (b) Exposure monitoring records. Owners or operators are required 
to retain monitoring records in accordance with 29 CFR 1910.1052(m)(2) 
Additionally, for each monitoring event of methylene chloride required 
under this subpart, owners or operators must document the following:
    (1) All measurements that may be necessary to determine the 
conditions that may affect the monitoring results;
    (2) The identity of all other potentially exposed persons whose 
exposure was not measured but whose exposure is intended to be 
represented by the area or representative sampling monitoring;
    (3) Use of established analytical methods;
    (4) Compliance with the Good Laboratory Practice Standards in 
accordance with 40 CFR part 792; and
    (5) Information regarding air monitoring equipment including: type, 
maintenance, calibrations, performance tests, limits of detection, and 
any malfunctions.
    (c) Exposure control records. Owners or operators must retain 
records of:
    (i) Exposure control plan as described in Sec.  751.109(e)(2);
    (ii) Regulated areas and authorized personnel;
    (iii) Facility exposure monitoring records;
    (iv) Notifications of exposure monitoring results;
    (v) Personal protective equipment (PPE) and respiratory protection 
used by potentially exposed persons and program implementation, 
including fit-testing; and
    (vi) Information and training provided pursuant to subsection (i) 
of this section.
    (d) Records related to Sec.  751.115 exemptions. To maintain 
eligibility for an exemption described in Sec.  751.115, the records 
maintained by the owners or operators must demonstrate compliance with 
the specific conditions of the exemption.
    (e) Minimum record retention period. The records required under 
paragraphs (a) through (c) of this section must be retained for at 
least 5 years from the date that such records were generated.
0
10. Add Sec.  751.115 to subpart B to read as follows:


Sec.  751.115  Exemptions.

    (a) In general. (1) Time-limited exemptions as described in 
paragraphs (b)(1) through (3) of this section provided for through 
Sec.  751.107(b)(7) are established in this section in accordance with 
15 U.S.C. 2605(g)(1)(B).
    (2) Time-limited exemptions as described in paragraph (b)(4) of 
this section are established in this section in accordance with 15 
U.S.C. 2605(g)(1)(A).
    (3) In order to be eligible for the exemptions established in this 
section, regulated parties must comply with all conditions established 
for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
    (b) Time-limited exemptions. (1) Paint or coating removal from 
safety-critical, corrosion-sensitive components of aircraft owned or 
operated by air carriers or commercial operators certificated under 14 
CFR part 119 until [DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL 
RULE IN THE FEDERAL REGISTER]. The following are specific conditions of 
this exemption:
    (i) The paint or coating removal must be performed on the premises 
of maintenance or repair facilities operated by air carriers or 
commercial operators certificated under 14 CFR part 119 or at repair 
stations certificated under 14 CFR part 145, if their primary business 
is performing maintenance, preventive maintenance, rebuilding, or 
alteration of aircraft operated by air carriers and commercial 
operators certificated under 14 CFR part 119.
    (ii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the Workplace 
Chemical Protection Program provisions in Sec.  751.109.
    (iii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the recordkeeping 
requirements in Sec.  751.113.
    (2) Paint and coating removal from safety-critical, corrosion-
sensitive components of aircraft intended for, or suitable for 
operation by, air carriers and commercial operators certificated under 
14 CFR part 119 until [DATE 10 YEARS AFTER DATE OF

[[Page 28346]]

PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER]. The following are 
specific conditions of this exemption:
    (i) The paint or coating removal must be performed at locations 
owned or operated by the manufacturer of the aircraft.
    (ii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the Workplace 
Chemical Protection Program provisions in Sec.  751.109.
    (iii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the recordkeeping 
requirements in Sec.  751.113.
    (3) Paint and coating removal from safety-critical, corrosion-
sensitive components of spacecraft used in, or intended for use in, 
commercial space transportation operations subject to 14 CFR chapter 
III, including payloads such as satellites and similar hardware, until 
[DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL 
REGISTER]. The following are specific conditions of this exemption:
    (i) The paint or coating removal must be performed at locations 
owned or operated by the manufacturer of the spacecraft or payload or 
similar hardware.
    (ii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the Workplace 
Chemical Protection Program provisions in Sec.  751.109.
    (iii) The owner or operator of the location where the paint or 
coating removal is being performed must comply with the recordkeeping 
requirements in Sec.  751.113.
    (4) Use of methylene chloride or methylene chloride-containing 
products identified in paragraph (b)(4)(i) of this section in an 
emergency by the National Aeronautics and Space Administration and its 
contractors operating within the scope of their contracted work until 
[DATE 10 YEARS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE FEDERAL 
REGISTER].
    (i) Applicability. The emergency use exemption described in this 
paragraph (b)(4) shall apply to the following specific conditions of 
use as described in paragraphs (b)(4)(i)(A)(1) through (7) of this 
section.
    (A) Conditions of use subject to this exemption:
    (1) Industrial and commercial use as solvent for cold cleaning
    (2) Industrial and commercial use as a solvent for aerosol spray 
degreaser/cleaner
    (3) Industrial and commercial use in adhesives, sealants and caulks
    (4) Industrial and commercial use in adhesive and caulk removers
    (5) Industrial and commercial use in metal non-aerosol degreasers
    (6) Industrial and commercial use in non-aerosol degreasers and 
cleaners
    (7) Industrial and commercial use as solvent that becomes part of a 
formulation or mixture
    (B) Emergency use:
    (1) In general. An emergency is a serious and sudden situation 
requiring immediate action, within 15 days or less, necessary to 
protect:
    (i) Safety of National Aeronautics and Space Administration's or 
their contractors' personnel;
    (ii) National Aeronautics and Space Administration's missions;
    (iii) Human health, safety, or property, including that of adjacent 
communities; or
    (iv) The environment.
    (2) Duration. Each emergency is a separate situation; if use of 
methylene chloride exceeds 15 days, then justification must be 
documented.
    (3) Eligibility. To be eligible for the exemption, the National 
Aeronautics and Space Administration and its contractors must:
    (i) Select methylene chloride because there are no technically and 
economically feasible safer alternatives available during the 
emergency.
    (ii) Perform the emergency use of methylene chloride at locations 
controlled by National Aeronautics and Space Administration or its 
contractors.
    (ii) Requirements. To be eligible for the emergency use exemption 
described in this paragraph (b)(4), National Aeronautics and Space 
Administration and its contractors must comply with the following 
conditions:
    (A) Notification. Within 15 days of the emergency use by National 
Aeronautics and Space Administration and its contractors, National 
Aeronautics and Space Administration must provide notice to EPA that 
includes the following:
    (1) Identification of the conditions of use detailed in paragraph 
(b)(4)(i)(A) of this section that the emergency use fell under;
    (2) An explanation for why the emergency use met the definition of 
emergency in paragraph (b)(4)(i)(B) of this section; and
    (3) An explanation of why methylene chloride was selected, 
including why there were no technically and economically feasible safer 
alternatives available in the particular emergency.
    (B) Exposure. The owner or operator must comply with the Workplace 
Chemical Protection Program provisions in Sec.  751.109, to the extent 
technically feasible in light of the particular emergency.
    (C) Recordkeeping. The owner or operator of the location where the 
use takes place must comply with the recordkeeping requirements in 
Sec.  751.113.

[FR Doc. 2023-09184 Filed 5-2-23; 8:45 am]
BILLING CODE 6560-50-P