Document ID: EPA-HQ-OPPT-2016-0742-0145
Agency: epa
Document Type: Notice
Title: Methylene Chloride; Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability
Posted Date: 2022-11-10T05:00Z

[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67901-67907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24533]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0742; FRL-9946-02-OCSPP]

Methylene Chloride; Revision to Toxic Substances Control Act 
(TSCA) Risk Determination; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final revision to the risk determination for the 
methylene chloride risk evaluation issued under the Toxic Substances 
Control Act (TSCA). The revision to the methylene chloride risk 
determination reflects the announced policy changes to ensure the 
public is protected from unreasonable risks from chemicals in a way 
that is supported by science and the law. EPA determined that methylene 
chloride, as a whole chemical substance, presents an unreasonable risk 
of injury to health when evaluated under its conditions of use. In 
addition, this revised risk determination does not reflect an 
assumption that workers always appropriately wear personal protective 
equipment (PPE). EPA understands that there could be occupational 
safety protections in place at workplace locations; however, not 
assuming use of PPE reflects EPA's recognition that unreasonable risk 
may exist for subpopulations of workers that may be highly exposed 
because they are not covered by Occupational Safety and Health 
Administration (OSHA) standards, or their employers are out of 
compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are 
described by OSHA as being ``outdated and inadequate for ensuring 
protection of worker health,'' or because the OSHA permissible exposure 
limit (PEL) alone may be inadequate for ensuring protection of worker 
health, or because EPA finds unreasonable risk for purposes of TSCA 
notwithstanding OSHA requirements. This revision supersedes the 
condition of use-specific no unreasonable risk determinations in the 
June 2020 Methylene Chloride Risk Evaluation and withdraws the 
associated TSCA order included in the June 2020 Methylene Chloride Risk 
Evaluation.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0742, is available online 
at https://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Additional instructions on 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, Office of 
Pollution Prevention and Toxics (7404M), 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: 

[[Page 67902]]

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to those involved in the manufacture, processing, 
distribution, use, disposal, and/or the assessment of risks involving 
chemical substances and mixtures. You may be potentially affected by 
this action if you manufacture (defined under TSCA to include import), 
process (including recycling), distribute in commerce, use or dispose 
of methylene chloride, including methylene chloride in products. Since 
other entities may also be interested in this revision to the risk 
determination, EPA has not attempted to describe all the specific 
entities that may be affected by this action.

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

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other nonrisk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
(PESS) identified as relevant to the risk evaluation by the 
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A). 
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and 
minimum requirements applicable to this process, including provisions 
that provide instruction on chemical substances that must undergo 
evaluation, the minimum components of a TSCA risk evaluation, and the 
timelines for public comment and completion of the risk evaluation. 
TSCA also requires that EPA operate in a manner that is consistent with 
the best available science, make decisions based on the weight of the 
scientific evidence, and consider reasonably available information. 15 
U.S.C. 2625(h), (i), and (k).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    EPA has inherent authority to reconsider previous decisions and to 
revise, replace, or repeal a decision to the extent permitted by law 
and supported by reasoned explanation. FCC v. Fox Television Stations, 
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. 
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983).

C. What action is EPA taking?

    EPA is announcing the availability of the final revision to the 
risk determination for the methylene chloride risk evaluation issued 
under TSCA that published in June 2020 (Ref. 1). In July 2022, EPA 
sought public comment on the draft revisions (87 FR 39824, July 5, 
2022). EPA appreciates the public comments received on the draft 
revision to the methylene chloride risk determination. After review of 
these comments and consideration of the specific circumstances of 
methylene chloride, EPA concludes that the Agency's risk determination 
for methylene chloride is better characterized as a whole chemical risk 
determination rather than condition-of-use-specific risk 
determinations. Accordingly, EPA is revising and replacing Section 5 of 
the June 2020 Methylene Chloride Risk Evaluation (Ref. 2) where the 
findings of unreasonable risk to health were previously made for the 
individual conditions of use evaluated. EPA is also withdrawing the 
previously issued TSCA section 6(i)(l) order for six conditions of use 
previously determined not to present unreasonable risk which was 
included in Section 5.4.1 of the June 2020 Methylene Chloride Risk 
Evaluation (Ref. 2).
    This final revision to the methylene chloride risk determination is 
consistent with EPA's plans to revise specific aspects of the first ten 
TSCA chemical risk evaluations to ensure that the risk evaluations 
better align with TSCA's objective of protecting health and the 
environment. As a result of this revision, removing the assumption that 
workers always and appropriately wear PPE (see Unit II.C.) means that: 
five additional conditions of use in addition to the original 47 drive 
the unreasonable risk determination for methylene chloride; inhalation 
risk to workers in addition to the previously identified inhalation 
risk to occupational non-users (ONUs) drive the unreasonable risk in 
three conditions of use; and additional risk to workers for acute and 
chronic non-cancer dermal exposures and for cancer from inhalation 
exposures also drive the unreasonable risk in many of those 52 
conditions of use (where previously those conditions of use were 
identified as presenting unreasonable risk only for chronic non-cancer 
effects and/or acute effects). However, EPA is not making condition-of-
use-specific risk determinations for those conditions of use, and for 
purposes of TSCA section 6(i), EPA is not issuing a final order under 
TSCA section 6(i)(1) and does not consider the revised risk 
determination to constitute a final agency action at this point in 
time. Overall, 52 conditions of use out of 53 EPA evaluated drive the 
methylene chloride whole chemical unreasonable risk determination due 
to risks identified for human health. The full list of the conditions 
of use evaluated for the methylene chloride TSCA risk evaluation is in 
Tables 4-2 and 4-3 of the June 2020 Methylene Chloride Risk Evaluation 
(Ref. 2).

II. Background

A. Why is EPA re-issuing the risk determination for the methylene 
chloride risk evaluation conducted under TSCA?

    In accordance with Executive Order 13990 (``Protecting Public 
Health and the Environment and Restoring Science to Tackle the Climate 
Crisis'') and other Administration priorities (Refs. 3, 4, 5, and 6), 
EPA reviewed the risk evaluations for the first ten chemical 
substances, including methylene chloride, to ensure that they meet the 
requirements of TSCA, including conducting decision-making in a manner 
that is consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment (Ref. 
7). Following a review of specific aspects of the June 2020 Methylene 
Chloride Risk Evaluation (Ref. 2) and after considering

[[Page 67903]]

comments received on a draft revised risk determination for methylene 
chloride, EPA has determined that making an unreasonable risk 
determination for methylene chloride as a whole chemical substance, 
rather than making unreasonable risk determinations separately on each 
individual condition of use evaluated in the risk evaluation, is the 
most appropriate approach for methylene chloride under the statute and 
implementing regulations. In addition, EPA's final risk determination 
is explicit insofar as it does not rely on assumptions regarding the 
use of PPE in making the unreasonable risk determination under TSCA 
section 6, even though some facilities might be using PPE as one means 
to reduce worker exposures; rather, the use of PPE as a means of 
addressing unreasonable risk will be considered during risk management, 
as appropriate.
    Separately, EPA is conducting a screening approach to assess 
potential risks from the air and water pathways for several of the 
first 10 chemicals, including this chemical. For methylene chloride the 
exposure pathways that were or could be regulated under another EPA 
administered statute were excluded from the final risk evaluation (see 
section 1.4.2 of the June 2020 Methylene Chloride Risk Evaluation). 
This resulted in the surface water, drinking water and ambient air 
pathways for methylene chloride not being assessed. The goal of the 
recently-developed screening approach is to remedy this exclusion and 
to identify if there may be risks that were unaccounted for in the 
methylene chloride risk evaluation.
    The screening-level approach has gone through public comment and 
independent external peer review through the SACC. The Agency received 
the final peer review report on May 18, 2022, and has reviewed public 
comments and SACC comments. EPA expects to describe its views regarding 
the chemical-specific application of this screening-level approach in 
the forthcoming proposed rule under TSCA section 6(a) for methylene 
chloride.
    This action pertains only to the risk determination for methylene 
chloride. While EPA intends to consider and may take additional similar 
actions on other of the first ten chemicals, EPA is taking a chemical-
specific approach to reviewing these risk evaluations and is 
incorporating new policy direction in a surgical manner, while being 
mindful of Congressional direction on the need to complete risk 
evaluations and move toward any associated risk management activities 
in accordance with statutory deadlines.

B. What is a whole chemical view of the unreasonable risk determination 
for the methylene chloride risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
    As explained in the Federal Register document announcing the 
availability of the draft revised risk determination for methylene 
chloride (87 FR 39824, July 5, 2022 (FRL-9946-01-OCSPP)), the proposed 
Risk Evaluation Procedural Rule (Ref. 8) was premised on the whole 
chemical approach to making unreasonable risk determinations. In that 
proposed rule, EPA acknowledged a lack of specificity in statutory text 
that might lead to different views about whether the statute compelled 
EPA's risk evaluations to address all conditions of use of a chemical 
substance or whether EPA had discretion to evaluate some subset of 
conditions of use (i.e., to scope out some manufacturing, processing, 
distribution in commerce, use, or disposal activities), but also stated 
that ``EPA believes the word `the' [in TSCA section 6(b)(4)(A)] is best 
interpreted as calling for evaluation that considers all conditions of 
use.'' The proposed rule, however, was unambiguous on the point that 
unreasonable risk determinations would be for the chemical substance as 
a whole, even if based on a subset of uses. See Ref. 8 at pages 7565-66 
(``TSCA section 6(b)(4)(A) specifies that a risk evaluation must 
determine whether `a chemical substance' presents an unreasonable risk 
of injury to health or the environment `under the conditions of use.' 
The evaluation is on the chemical substance--not individual conditions 
of use--and it must be based on `the conditions of use.' In this 
context, EPA believes the word `the' is best interpreted as calling for 
evaluation that considers all conditions of use.''). In the proposed 
regulatory text, EPA proposed to determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use. (Ref. 8 at 7480.)
    The final Risk Evaluation Procedural Rule stated (82 FR 33726, July 
20, 2017 (FRL-9964-38)) (Ref. 9): ``As part of the risk evaluation, EPA 
will determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under each condition of 
uses [sic] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents'' (40 CFR 702.47). 
For the unreasonable risk determinations in the first ten risk 
evaluations, EPA applied this provision by making individual risk 
determinations for each condition of use evaluated as part of each risk 
evaluation document (i.e., the condition-of-use-specific approach to 
risk determinations). That approach was based on one particular passage 
in the preamble to the final Risk Evaluation Rule which stated that EPA 
will make individual risk determinations for all conditions of use 
identified in the scope. (Ref. 9 at 33744).
    In contrast to this portion of the preamble of the final Risk 
Evaluation Rule, the regulatory text itself and other statements in the 
preamble reference a risk determination for the chemical substance 
under its conditions of use, rather than separate risk determinations 
for each of the conditions of use of a chemical substance. In the key 
regulatory provision excerpted previously from 40 CFR 702.47, the text 
explains that ``[a]s part of the risk evaluation, EPA will determine 
whether the chemical substance presents an unreasonable risk of injury 
to health or the environment under each condition of uses [sic] within 
the scope of the risk evaluation, either in a single decision document 
or in multiple decision documents'' (Ref. 9, emphasis added). Other 
language reiterates this perspective. For example, 40 CFR 702.31(a) 
states that the purpose of the rule is to establish the EPA process for 
conducting a risk evaluation to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment as 
required under TSCA section 6(b)(4)(B). Likewise, there are recurring 
references to whether the chemical substance presents an unreasonable 
risk in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which 
explains that the extent to which EPA will refine its evaluations for 
one or more condition of use in any risk evaluation will vary as 
necessary to determine whether a chemical substance presents an 
unreasonable risk. Notwithstanding the one preambular statement about 
condition-of-use-specific risk

[[Page 67904]]

determinations, the preamble to the final rule also contains support 
for a risk determination on the chemical substance as a whole. In 
discussing the identification of the conditions of use of a chemical 
substance, the preamble notes that this task inevitably involves the 
exercise of discretion on EPA's part, and ``as EPA interprets the 
statute, the Agency is to exercise that discretion consistent with the 
objective of conducting a technically sound, manageable evaluation to 
determine whether a chemical substance--not just individual uses or 
activities--presents an unreasonable risk'' (Ref. 9 at 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue whole-chemical 
risk determinations. Either approach is permissible under the 
regulation. A panel of the Ninth Circuit Court of Appeals also 
recognized the ambiguity of the regulation on this point. Safer 
Chemicals v. EPA, 943 F.3d. 397, 413 (9th Cir. 2019) (holding a 
challenge about ``use-by-use risk evaluations [was] not justiciable 
because it is not clear, due to the ambiguous text of the Risk 
Evaluation Rule, whether the Agency will actually conduct risk 
evaluations in the manner Petitioners fear'').
    EPA plans to consider the appropriate approach for each chemical 
substance risk evaluation on a case-by-case basis, taking into account 
considerations relevant to the specific chemical substance in light of 
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's 
ability to evaluate and manage unreasonable risk from individual 
chemical substances. EPA believes this is a reasonable approach under 
TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of methylene chloride, 
EPA has determined that a whole chemical approach is appropriate for 
methylene chloride in order to protect health. The whole chemical 
approach is appropriate for methylene chloride because there are 
benchmark exceedances for a substantial number of conditions of use 
(spanning across most aspects of the chemical lifecycle-from 
manufacturing (including import), processing, industrial and commercial 
use, consumer use, and disposal) for workers, occupational non-users, 
consumers, and bystanders and irreversible health effects (specifically 
cancer, coma, hypoxia, and death) associated with methylene chloride 
exposures. Because these chemical-specific properties cut across the 
conditions of use within the scope of the risk evaluation, a 
substantial number of the conditions of use drive the unreasonable 
risk; therefore, it is appropriate for the Agency to make a 
determination for methylene chloride that the whole chemical presents 
an unreasonable risk.
    As explained later in this document, the revisions to the 
unreasonable risk determination (Section 5 of the June 2020 Methylene 
Chloride Risk Evaluation (Ref. 2)) follow the issuance of a draft 
revision to the TSCA methylene chloride unreasonable risk determination 
(87 FR 39824, July 5, 2022) and the receipt of public comment. A 
response to comments document is also being issued with the final 
revised unreasonable risk determination for methylene chloride (Ref. 
10). The revisions to the unreasonable risk determination are based on 
the existing risk characterization section of the June 2020 Methylene 
Chloride Risk Evaluation (Ref. 2) (Section 4) and do not involve 
additional technical or scientific analysis. The discussion of the 
issues in this Federal Register document and in the accompanying final 
revised risk determination for methylene chloride supersede any 
conflicting statements in the June 2020 Methylene Chloride Risk 
Evaluation (Ref. 2) and the earlier response to comments document (Ref. 
11). EPA views the peer reviewed hazard and exposure assessments and 
associated risk characterization as robust and upholding the standards 
of best available science and weight of the scientific evidence per 
TSCA sections 26(h) and (i).
    For purposes of TSCA section 6(i), EPA is making a risk 
determination on methylene chloride as a whole chemical. Under the 
revised approach, the ``whole chemical'' risk determination for 
methylene chloride supersedes the no unreasonable risk determinations 
for methylene chloride that were premised on a condition-of-use-
specific approach to determining unreasonable risk and also contains an 
order withdrawing the TSCA section 6(i)(1) order in Section 5.4.1 of 
the June 2020 Methylene Chloride Risk Evaluation (Ref. 2).

C. What revision is EPA now making final about the use of PPE for the 
methylene chloride risk evaluation?

    In the risk evaluations for the first ten chemical substances, as 
part of the unreasonable risk determination, EPA assumed for several 
conditions of use that workers were provided and always used PPE in a 
manner that achieves the stated assigned protection factor (APF) for 
respiratory protection, or used impervious gloves for dermal 
protection. In support of this assumption, EPA used reasonably 
available information such as public comments indicating that some 
employers, particularly in the industrial setting, provide PPE to their 
employees and follow established worker protection standards (e.g., 
OSHA requirements for protection of workers).
    For the June 2020 Methylene Chloride Risk Evaluation (Ref. 2), EPA 
assumed, based on reasonably available information, including public 
comment and safety data sheets for methylene chloride, that workers use 
PPE--specifically respirators with an APF ranging from 25 to 50--for 26 
occupational conditions of use and gloves with PF 10 or 20 for 39 
occupational conditions of use. However, in the June 2020 Methylene 
Chloride Risk Evaluation, EPA determined that there is unreasonable 
risk to workers for 32 of those conditions of use.
    EPA is revising the assumption for methylene chloride that workers 
always and properly use PPE, although it does not question the public 
comments received 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 of workers 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. It should be 
noted that, in some cases, baseline conditions may reflect certain 
mitigation measures, such as engineering controls, in instances where 
exposure estimates are based on monitoring data at facilities that have 
engineering controls in place.
    In addition, EPA believes it is appropriate to evaluate the levels 
of risk present in scenarios considering applicable OSHA requirements 
(e.g., chemical-specific permissible exposure limits (PELs) and/or 
chemical-specific PELs with additional substance-specific standards), 
as well as scenarios considering industry or sector best practices for 
industrial hygiene that are clearly articulated to the Agency. 
Consistent with this approach, the June 2020 Methylene Chloride Risk

[[Page 67905]]

Evaluation (Ref. 2) characterized risk to workers both with and without 
the use of PPE. 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, or to ensure that 
applicable OSHA requirements or industry or sector best practices that 
address the unreasonable risk are required for all potentially exposed 
and susceptible subpopulations (including self-employed individuals and 
public sector workers who are not covered by an OSHA State Plan).
    When undertaking unreasonable risk determinations as part of TSCA 
risk evaluations, however, EPA does not believe it is appropriate to 
assume as a general matter that an applicable OSHA requirement or 
industry practice related to PPE use is consistently and always 
properly applied. Mitigation scenarios included in the EPA risk 
evaluation (e.g., scenarios considering use of various PPE) likely 
represent what is happening already in some facilities. However, the 
Agency cannot assume that all facilities have adopted these practices 
for the purposes of making the TSCA risk determination (Ref. 12).
    Therefore, EPA is making a determination of unreasonable risk for 
methylene chloride from a baseline scenario that does 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 the baseline scenario 
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 non-compliance 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 a State Plan, or because 
their employer is out of compliance with OSHA standards, or because 
many of OSHA's chemical-specific permissible exposure limits largely 
adopted in the 1970's are described by OSHA as being ``outdated and 
inadequate for ensuring protection of worker health,'' (Ref. 13) or 
because the OSHA Permissible Exposure Limit alone may be inadequate to 
protect human health, or because EPA finds unreasonable risk for 
purposes of TSCA notwithstanding OSHA requirements.
    In accordance with this approach, EPA is finalizing the revision to 
the methylene chloride risk determination without relying on 
assumptions regarding the occupational use of PPE in making the 
unreasonable risk determination under TSCA section 6; rather, 
information on the use of PPE as a means of mitigating risk (including 
public comments received from industry respondents about occupational 
safety practices in use) will be considered during the risk management 
phase, as appropriate. This represents a change from the approach taken 
in the June 2020 Methylene Chloride Risk Evaluation (Ref. 2). As a 
general matter, when undertaking risk management actions, EPA intends 
to strive for consistency with applicable OSHA requirements and 
industry best practices, including appropriate application of the 
hierarchy of controls, to the extent that applying those measures would 
address the identified unreasonable risk, including unreasonable risk 
to potentially exposed or susceptible subpopulations. Consistent with 
TSCA section 9(d), EPA will consult and coordinate 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 or be sufficient to 
address the unreasonable risk.
    Removing the assumption that workers always and appropriately wear 
PPE in making the whole chemical risk determination for methylene 
chloride means that: five conditions of use in addition to the original 
47 conditions of use drive the unreasonable risk for methylene 
chloride; an additional route of exposure (i.e., inhalation) is also 
identified as driving the unreasonable risk to workers in three 
conditions of use in addition to the previously identified inhalation 
risk to occupational non-users; and additional risks to workers for 
acute and chronic non-cancer dermal exposures and for cancer from 
inhalation exposures also drive the unreasonable risk in many of those 
52 conditions of use (where previously those conditions of use were 
identified as presenting unreasonable risk only for chronic non-cancer 
effects and/or acute effects). The finalized revision to the methylene 
chloride risk determination clarifies that EPA does not rely on the 
assumed use of PPE when making the risk determination for the whole 
substance.

D. What is methylene chloride?

    Methylene chloride, which is also called dichloromethane, is a 
volatile chemical that is produced and imported into the United States, 
with use estimated at over 260 million pounds per year. It is a solvent 
used in a variety of industries and applications, such as adhesives, 
paint and coating products, metal cleaning, chemical processing, and 
aerosols. In addition, it is used as a propellent, processing aid, or 
functional fluid in the manufacturing of other chemicals. A variety of 
consumer and commercial products use methylene chloride as a solvent 
including sealants, automotive products, and paint and coating 
removers. Methylene chloride is subject to federal and state 
regulations and reporting requirements.

E. What conclusions is EPA finalizing today in the revised TSCA risk 
evaluation based on the whole chemical approach and not assuming the 
use of PPE?

    EPA determined that methylene chloride presents an unreasonable 
risk to health under the conditions of use. EPA's unreasonable risk 
determination for methylene chloride as a chemical substance is driven 
by risks associated with the following conditions of use, considered 
singularly or in combination with other exposures:
     Manufacturing--Domestic manufacture;
     Manufacturing--Import;
     Processing into a formulation, mixture, or reaction 
product;
     Processing as a reactant;
     Processing: recycling;
     Repackaging;
     Industrial and commercial use as solvent for batch vapor 
degreasing;
     Industrial and commercial use as solvent for in-line vapor 
degreasing;
     Industrial and commercial use as solvent for cold 
cleaning; and commercial use as a solvent for aerosol spray degreasers/
cleaners;
     Industrial and commercial use in adhesives, sealants, and 
caulks;
     Industrial and commercial use in paints and coatings;
     Industrial and commercial use in paint and coating 
removers;

[[Page 67906]]

     Industrial and commercial use in adhesive and caulk 
removers;
     Industrial and commercial use as metal aerosol degreasers;
     Industrial and commercial use in metal non-aerosol 
degreasers;
     Industrial and commercial use in finishing products for 
fabric, textiles, and leather;
     Industrial and commercial use in automotive care products 
(functional fluids for air conditioners);
     Industrial and commercial use in automotive care products 
(interior car care);
     Industrial and commercial use in automotive care products 
(degreasers);
     Industrial and commercial use in apparel and footwear care 
products;
     Industrial and commercial use in spot removers for apparel 
and textiles;
     Industrial and commercial use in liquid lubricants and 
greases;
     Industrial and commercial use in spray lubricants and 
greases;
     Industrial and commercial use in aerosol degreasers and 
cleaners;
     Industrial and commercial use in non-aerosol degreasers 
and cleaners;
     Industrial and commercial use in cold pipe insulations;
     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 as propellant and blowing 
agent;
     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 for cellulose triacetate 
film production;
     Industrial and commercial use as anti-spatter welding 
aerosol;
     Industrial and commercial use for oil and gas drilling, 
extraction, and support activities;
     Industrial and commercial uses for toys, playgrounds, and 
sporting equipments (including novelty articles);
     Industrial and commercial use for carbon removers, wood 
floor cleaners, and brush cleaners;
     Industrial and commercial use as a lithographic printing 
plate cleaner;
     Industrial and commercial use as a laboratory chemical;
     Consumer use as a solvent in an aerosol cleaner/degreaser;
     Consumer use in adhesives and sealants;
     Consumer use in paints and coatings (brush cleaners for 
paints and coatings);
     Consumer use in adhesives/caulk removers;
     Consumer use in aerosol and non- aerosol metal degreasers;
     Consumer use in automotive functional fluids (air 
conditioners refrigerant, treatment, leak sealer);
     Consumer use in automotive degreasers (gasket remover, 
transmission cleaners, carburetor);
     Consumer use in aerosol and non-aerosol lubricants and 
greases, consumer use in cold pipe insulation;
     Consumer use in aerosol and non-aerosol lubricants/greases 
and aerosol and non-aerosol degreaser/cleaners;
     Consumer use in cold pipe insulation;
     Consumer use in crafting glue and cement/concrete;
     Consumer use in anti-adhesive agent--anti-spatter welding 
aerosol;
     Consumer use in carbon remover and brush cleaner; and
     Disposal.
    The following condition of use does not drive EPA's unreasonable 
risk determination for methylene chloride:
     Distribution in commerce.
    EPA is not making a condition of use-specific risk determination 
for this condition of use, is not issuing a final order under TSCA 
section 6(i)(1) for this condition of use, and does not consider the 
revised risk determination for methylene chloride to constitute a final 
agency action at this point in time.
    Consistent with the statutory requirements of TSCA section 6(a), 
EPA will propose a risk management regulatory action to the extent 
necessary so that methylene chloride no longer presents an unreasonable 
risk. EPA expects to focus its risk management action on the conditions 
of use that drive the unreasonable risk. However, it should be noted 
that, under TSCA section 6(a), EPA is not limited to regulating the 
specific activities found to drive unreasonable risk and may select 
from among a suite of risk management requirements in section 6(a) 
related to manufacture (including import), processing, distribution in 
commerce, commercial use, and disposal as part of its regulatory 
options to address the unreasonable risk. As a general example, EPA may 
regulate upstream activities (e.g., processing, distribution in 
commerce) to address downstream activities (e.g., consumer uses) 
driving unreasonable risk, even if the upstream activities do not drive 
the unreasonable risk.

III. Summary of Public Comments

    EPA received a total of 20 public comments on the July 5, 2022, 
draft revised risk determination for methylene chloride during the 
comment period that ended August 4, 2022, of which 19 were unique and 
responsive to the request for comments. Commenters included trade 
organizations, industry stakeholders, environmental groups, and non-
governmental health advocacy organizations. A separate document that 
summarizes all comments submitted and EPA's responses to those comments 
has been prepared and is available in the docket for this notice (Ref. 
10).

IV. Revision of the June 2020 Methylene Chloride Risk Evaluation

A. Why is EPA revising the risk determination for the methylene 
chloride risk evaluation?

    EPA is finalizing the revised risk determination for the methylene 
chloride risk evaluation 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. 3, 4, 5, and 6). EPA is revising 
specific aspects of the first ten TSCA existing chemical risk 
evaluations in order to ensure that the risk evaluations better align 
with TSCA's objective of protecting health and the environment. For the 
methylene chloride risk evaluation, this includes: (1) Making the risk 
determination in this instance based on the whole chemical substance 
instead of by individual conditions of use and (2) Emphasizing that EPA 
does not rely on the assumed use of PPE when making the risk 
determination.

B. What are the revisions?

    EPA is now finalizing the revised risk determination for the June 
2020 Methylene Chloride Risk Evaluation (Ref. 2) pursuant to TSCA 
section 6(b). Under the revised determination (Ref. 1), EPA concludes 
that methylene chloride, as evaluated in the risk evaluation as a 
whole, presents an unreasonable risk of injury to health when evaluated 
under its conditions of use. This revision replaces the previous 
unreasonable risk determinations made for methylene chloride by 
individual conditions of use, supersedes the determinations (and 
withdraws the associated order) of no unreasonable risk for the 
conditions of use identified in the TSCA section 6(i)(1) no 
unreasonable risk order, and clarifies the lack of reliance on assumed 
use of PPE as part of the risk determination.
    These revisions do not alter any of the underlying technical or 
scientific information that informs the risk characterization, and as 
such the hazard, exposure, and risk characterization sections are not

[[Page 67907]]

changed, except to statements about PPE assumptions in Section 2.4.1.1 
(Consideration of Engineering Controls and PPE). The discussion of the 
issues in this Notice and in the accompanying final revision to the 
risk determination supersede any conflicting statements in the prior 
executive summary, and Section 2.4.1.1 from the June 2020 Methylene 
Chloride Risk Evaluation (Ref. 2) and the response to comments document 
(Ref. 11).
    The revised unreasonable risk determination for methylene chloride 
includes additional explanation of how the risk evaluation 
characterizes the applicable OSHA requirements, or industry or sector 
best practices, and also clarifies that no additional analysis was 
done, and the risk determination is based on the risk characterization 
(Section 4) of the June 2020 Methylene Chloride Risk Evaluation (Ref. 
2).

C. Will the revised risk determination be peer reviewed?

    The risk determination (Section 5 of the June 2020 Methylene 
Chloride Risk Evaluation (Ref. 2)) was not part of the scope of the 
Science Advisory Committee on Chemicals (SACC) peer review of the 
methylene chloride risk evaluation. Thus, consistent with that 
approach, EPA did not conduct peer review of the final revised 
unreasonable risk determination for the methylene chloride risk 
evaluation because no technical or scientific changes were made to the 
hazard or exposure assessments or the risk characterization.

V. Order Withdrawing Previous Order Regarding Unreasonable Risk 
Determinations for Certain Conditions of Use

    EPA is also issuing a new order to withdraw the TSCA Section 
6(i)(1) no unreasonable risk order issued in Section 5.4.1 of the 2020 
methylene chloride Risk Evaluation (Ref. 2). This final revised risk 
determination supersedes the condition of use-specific no unreasonable 
risk determinations in the June 2020 Methylene Chloride Risk Evaluation 
(Ref. 2). The order contained in Section 5.5 of the revised risk 
determination (Ref. 1) withdraws the TSCA section 6(i)(1) order 
contained in Section 5.4.1 of the June 2020 Methylene Chloride Risk 
Evaluation (Ref. 2). Consistent with the statutory requirements of 
section 6(a), the Agency will propose risk management action to address 
the unreasonable risk determined in the methylene chloride risk 
evaluation.

VI. 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 physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Unreasonable Risk Determination for Methylene Chloride. 
October 2022.
2. EPA. Risk Evaluation for Methylene Chloride. June 2020. EPA 
Document #740-R1-8010. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0107.
3. 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).
4. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 25, 2021).
5. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register (86 FR 7619, February 1, 2021).
6. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
7. EPA. Press Release: EPA Announces Path Forward for TSCA Chemical 
Risk Evaluations. June 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register (82 FR 
7562, January 19, 2017) (FRL-9957-75).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register (82 FR 
33726, 33744, July 20, 2017).
10. EPA. Response to Public Comments to the Revised Unreasonable 
Risk Determination; Methylene Chloride (MC). October 2022.
11. EPA. Summary of External Peer Review and Public Comments and 
Disposition for Methylene Chloride (MC). June 2020. Available at: 
https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0083.
12. Occupational Safety and Health Administration (OSHA). Top 10 
Most Frequently Cited Standards for Fiscal Year 2021 (Oct. 1, 2020, 
to Sept. 30, 2021). Accessed October 13, 2022. https://www.osha.gov/top10citedstandards
13. OSHA. Permissible Exposure Limits--Annotated Tables. Accessed 
June 13, 2022. https://www.osha.gov/annotated-pels.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 4, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-24533 Filed 11-9-22; 8:45 am]
BILLING CODE 6560-50-P