Notice2022-14163
Methylene Chloride; Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 5, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and seeking public comment on a draft revision to the risk determination for the methylene chloride risk evaluation issued under TSCA. The draft 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. In this draft revision to the risk determination EPA finds 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 all 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 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of OSHA's chemical-specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being "outdated and inadequate for ensuring protection of worker health," or because the OSHA permissible exposure limit (PEL) alone may be inadequate for ensuring protection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. This revision, when final, would supersede the condition of use-specific no unreasonable risk determinations in the June 2020 methylene chloride risk evaluation (and withdraw the associated order) and would make a revised determination of unreasonable risk for methylene chloride as a whole chemical substance.
Full Text
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[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39824-39830]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14163]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0742 FRL-9946-01-OCSPP]
Methylene Chloride; Draft Revision to Toxic Substances Control
Act (TSCA) Risk Determination; Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and seeking public comment on a draft revision to the
risk determination for the methylene chloride risk evaluation issued
under TSCA. The draft 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. In this draft revision to the
risk determination EPA finds 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 all 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
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. This
revision, when final, would supersede the condition of use-specific no
unreasonable risk determinations in the June 2020 methylene chloride
risk evaluation (and withdraw the associated order) and would make a
revised determination of unreasonable risk for methylene chloride as a
whole chemical substance.
DATES: Comments must be received on or before August 4, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-EPA-HQ-OPPT-2016-0742, using the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Ingrid Feustel, 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:
<a href="/cdn-cgi/l/email-protection#cfa9aababcbbaaa3e1a6a1a8bda6ab8faabfaee1a8a0b9"><span class="__cf_email__" data-cfemail="3d5b58484e4958511354535a4f54597d584d5c135a524b">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#57030414167a1f38233b3e39321732273679303821"><span class="__cf_email__" data-cfemail="6e3a3d2d2f4326011a0207000b2e0b1e0f40090118">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 39825]]
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public in general. This action may,
however, 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 draft
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 non-risk 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 non-risk
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). Further, on
July 14, 2021, the Ninth Circuit granted EPA's motion for voluntary
remand without vacatur, so that EPA may conduct reconsideration
proceedings on the methylene chloride Risk Evaluation--particularly to
reconsider the no unreasonable risk determinations made within.
Neighbors for Environmental Justice et al., v. U.S. Environmental
Protection Agency et al., (9th Cir. No. 20-72091).
C. What action is EPA taking?
EPA is announcing the availability of and seeking public comment on
a draft revision to the risk determination for the risk evaluation for
methylene chloride under TSCA, which was initially published in June
2020 (Ref. 1). EPA is specifically seeking public comment on the draft
revision to the risk determination for the risk evaluation where the
Agency intends to determine that methylene chloride, as a whole
chemical, presents an unreasonable risk of injury to health when
evaluated under its conditions of use. 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 would revise and replace section 5 of
the risk evaluation for methylene chloride where the findings of
unreasonable risk to health were previously made for the individual
conditions of use evaluated. EPA would also withdraw the order issued
previously for six conditions of use previously determined not to
present unreasonable risk.
This revision would be consistent with EPA's plans to revise
specific aspects of the first ten TSCA chemical risk evaluations in
order to ensure that the risk evaluations better align with TSCA's
objective of protecting health and the environment. Under the draft
revision, removing the assumption that workers always appropriately
wear PPE (see Unit II.C.) in making the whole chemical risk
determination for methylene chloride would mean that: five additional
conditions of use in addition to the original 47 would drive the
unreasonable risk determination for methylene chloride; inhalation
risks to workers in addition to the previously identified inhalation
risk to occupational non-users (ONUs) would 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 would 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 for acute effects) (Ref. 2 at pg. 319 provides the risk
estimates, and Table 5-1 in the risk determination (Ref. 1) provides
information related to the unreasonable risk). Overall, 52 conditions
of use out of 53EPA evaluated would 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
risk evaluation (Ref. 2).
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at
[[Page 39826]]
<a href="https://www.epa.gov/dockets/comments.html">https://www.epa.gov/dockets/comments.html</a>.
II. Background
A. Why is EPA re-issuing the risk determination for the methylene
chloride risk evaluation conducted under TSCA?
In 2016, as directed by TSCA section 6(b)(2)(A), EPA chose the
first ten chemical substances to undergo risk evaluations under the
amended TSCA. These chemical substances are asbestos, 1-bromopropane,
carbon tetrachloride, C.I. Pigment Violet 29, HBCD, 1,4-dioxane,
methylene chloride, n-methylpyrrolidone (NMP), perchloroethylene (PCE),
and trichloroethylene (TCE).
From June 2020 to January 2021, EPA published risk evaluations on
the first ten chemical substances, including for methylene chloride in
June 2020. The risk evaluations included individual unreasonable risk
determinations for each condition of use evaluated. EPA issued
determinations that particular conditions of use did not present an
unreasonable risk by order under TSCA section 6(i)(1).
In accordance with Executive Order 13990 (Ref. 3) and other
Administration priorities (Refs. 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). To that end, EPA is reconsidering two key aspects of the risk
determinations for methylene chloride published in June 2020. First,
following a review of specific aspects of the June 2020 methylene
chloride risk evaluation, EPA proposes that making an unreasonable risk
determination for HBCD 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 to HBCD under the statute and implementing
regulations. Second, EPA proposes that the risk determination should be
explicit that it does not rely on assumptions regarding the use of
personal protective equipment (PPE) in making the unreasonable risk
determination under TSCA section 6, even though some facilities might
be using PPE as one means to reduce workers exposures; rather, the use
of PPE would 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, ambient air, and
sediment pathways for methylene chloride not being assessed for human
health exposures or the general population. The goal of the recently-
developed screening approach is to remedy this exclusion and to
identify if there are risks that were unaccounted for in the methylene
chloride risk evaluation. While this analysis is underway, EPA is not
incorporating the screening-level approach into this draft revised
unreasonable risk determination. If the results suggest there is
additional risk, EPA will determine if the risk management approaches
being contemplated for methylene chloride will protect against these
risks or if the risk evaluation will need to be formally supplemented
or revised.
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 the risk evaluations and is
incorporating new policy direction in a surgical manner, while being
mindful of the 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.
The proposed risk evaluation procedural rule was premised on the
whole chemical approach to making an unreasonable risk determination
(Ref. 8). 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.'' (Ref. 8).
The proposed rule, however, was unambiguous on the point that an
unreasonable risk determination would be for the chemical substance as
a whole, even if based on a subset of uses. (See Ref. 8 at pgs. 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 pg. 7480).
The final risk evaluation procedural rule (Ref. 9) stated: ``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.'' (See also 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 in each risk evaluation (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
procedural rule, which stated that EPA will make individual risk
[[Page 39827]]
determinations for all conditions of use identified in the scope. (Ref.
9 at pg. 33744).
In contrast to this portion of the preamble of the final risk
evaluation procedural 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 earlier 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
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. 8 at pg. 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, as
further explained in this notice, EPA proposes that a whole chemical
approach is appropriate for methylene chloride in order to protect
health and the environment. The whole chemical approach is appropriate
for methylene chloride because there are benchmark exceedances for
multiple conditions of use (spanning across most aspects of the
chemical lifecycle--from manufacturing (including import), processing,
commercial and industrial use, consumer use, and disposal) for health
of workers, occupational non-users, consumers, and bystanders, and the
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 amount 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 risk evaluation)
would be based on the existing risk characterization section of the
risk evaluation (section 4 of the risk evaluation) and would not
involve additional technical or scientific analysis. The discussion of
the issues presented in this Federal Register notice and in the
accompanying draft revision to the risk determination would supersede
any conflicting statements in the prior methylene chloride risk
evaluation and the response to comments document (Ref. 10). With
respect to the methylene chloride risk evaluation, EPA intends to
change the risk determination to a whole chemical approach without
considering the use of PPE and does not intend to amend, nor does a
whole chemical approach require amending, the underlying scientific
analysis of the risk evaluation in the risk characterization section of
the risk evaluation. 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).
EPA is announcing the availability of and seeking public comment on
the draft superseding unreasonable risk determination for methylene
chloride, including a description of the risks driving the unreasonable
risk determination under the conditions of use for the chemical
substance as a whole. For purposes of TSCA section 6(i), EPA is making
a draft risk determination on methylene chloride as a whole chemical.
Under the proposed revised approach, the ``whole chemical risk
determination for methylene chloride would supersede the no
unreasonable risk determinations for methylene chloride that were
premised on a condition-of-use-specific approach to determining
unreasonable risk. When finalized, EPA's revised unreasonable risk
determination would also contain an order withdrawing the TSCA section
6(i)(1) order in section 5.4.1 of the June 2020 methylene chloride risk
evaluation. The draft revision to the risk determination would clarify
that EPA does not rely on the assumed use of PPE when making the risk
determination for the whole substance. EPA is requesting comment on
this potential change.
C. What revision does EPA propose 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 all 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 considered reasonably available
information such as public comments indicating that some employers,
particularly in the industrial
[[Page 39828]]
setting, provide PPE to their employees and follow established worker
protection standards (e.g., Occupational Safety and Health
Administration (OSHA) requirements for protection of workers,
specifically the existing OSHA standard for methylene chloride at 29
CFR 1910.1052).
For the June 2020 methylene chloride risk evaluation, 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 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 was unreasonable risk to workers
for 32 of those conditions of use. Overall, EPA determined that 36 of
the 41 occupational COUs present unreasonable risks to workers or
occupational non-users.
EPA is revising the assumption for methylene chloride that workers
always or properly use PPE, although it does not question the
information received regarding the occupational safety practices often
followed by industry respondents, including as part of compliance with
the OSHA methylene chloride standard. Notwithstanding that standard,
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. 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
evaluation 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 or
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 practices 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.
Therefore, EPA proposes to make its 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. 11) or because the OSHA Permissible Exposure Limit
alone may be inadequate to protect worker health, or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements.
In accordance with this approach, EPA is proposing the draft
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
information received from industry respondents about occupational
safety practices in use) would be considered during the risk management
phase as appropriate. This would represent a change from the approach
taken in the 2020 risk evaluation for methylene chloride and EPA
invites comments on this draft change to the methylene chloride risk
determination. 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, when those measures would
address an 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 assumptions that workers always and appropriately wear
PPE in making the whole chemical risk determination for methylene
chloride would add five additional conditions of use to the original 47
conditions of use that would drive EPA's unreasonable risk
determination for methylene chloride as a whole chemical. The five
conditions of use affected by this change are: manufacturing (domestic
manufacture); processing as a reactant; processing: recycling;
industrial and commercial use as laboratory chemical; and disposal.
Additionally, removing
[[Page 39829]]
this assumption would add inhalation risks to workers in addition to
the previously identified inhalation risk to occupational non-users as
driving the unreasonable risk in three conditions of use and would add
risks to workers for acute and chronic non-cancer dermal exposures and
for cancer from inhalation exposures as driving the unreasonable risk
in many conditions of use (Ref. 2 at pg. 319 provides the risk
estimates, and Table 5-1 in the risk determination (Ref. 1) provides
information related to the unreasonable risk).
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 did EPA reach about the risks of methylene chloride
in the 2020 TSCA risk evaluation and what conclusions is EPA proposing
to reach based on the whole chemical approach and not assuming the use
of PPE?
In the 2020 risk evaluation, EPA determined that methylene chloride
presents an unreasonable risk to health under the following conditions
of use:
<bullet> Manufacture (import);
<bullet> Processing into a formulation, mixture, or reaction
product;
<bullet> Repackaging;
<bullet> Industrial and commercial use as solvent for batch vapor
degreasing;
<bullet> Industrial and commercial use as solvent for in-line vapor
degreasing;
<bullet> Industrial and commercial use as solvent for cold
cleaning;
<bullet> and commercial use as a solvent for aerosol spray
degreasers/cleaners;
<bullet> Industrial and commercial use in adhesives, sealants, and
caulks;
<bullet> Industrial and commercial use in paints and coatings;
<bullet> Industrial and commercial use in paint and coating
removers;
<bullet> Industrial and commercial use in adhesive and caulk
removers;
<bullet> Industrial and commercial use as metal aerosol degreasers;
<bullet> Industrial and commercial use in metal non-aerosol
degreasers;
<bullet> Industrial and commercial use in finishing products for
fabric, textiles, and leather;
<bullet> Industrial and commercial use in automotive care products
(functional fluids for air conditioners);
<bullet> Industrial and commercial use in automotive care products
(interior car care);
<bullet> Industrial and commercial use in automotive care products
(degreasers);
<bullet> Industrial and commercial use in apparel and footwear care
products;
<bullet> Industrial and commercial use in spot removers for apparel
and textiles;
<bullet> Industrial and commercial use in liquid lubricants and
greases;
<bullet> Industrial and commercial use in spray lubricants and
greases;
<bullet> Industrial and commercial use in aerosol degreasers and
cleaners;
<bullet> Industrial and commercial use in non-aerosol degreasers
and cleaners;
<bullet> Industrial and commercial use in cold pipe insulations;
<bullet> Industrial and commercial use as solvent that becomes part
of a formulation or mixture;
<bullet> Industrial and commercial use as a processing aid;
<bullet> Industrial and commercial use as propellant and blowing
agent;
<bullet> Industrial and commercial use for electrical equipment,
appliance, and component manufacturing;
<bullet> Industrial and commercial use for plastic and rubber
products manufacturing;
<bullet> Industrial and commercial use for cellulose triacetate
film production;
<bullet> Industrial and commercial use as anti-spatter welding
aerosol;
<bullet> Industrial and commercial use for oil and gas drilling,
extraction, and support activities;
<bullet> Industrial and commercial uses for toys, playgrounds, and
sporting equipments (including novelty articles);
<bullet> Industrial and commercial use for carbon removers, wood
floor cleaners, and brush cleaners;
<bullet> Industrial and commercial use as a lithographic printing
plate cleaner;
<bullet> Consumer use as a solvent in an aerosol cleaner/degreaser;
<bullet> Consumer use in adhesives and sealants;
<bullet> Consumer use in paints and coatings (brush cleaners for
paints and coatings);
<bullet> Consumer use in adhesives/caulk removers;
<bullet> Consumer use in aerosol and non-aerosol metal degreasers;
<bullet> Consumer use in automotive functional fluids (air
conditioners refrigerant, treatment, leak sealer);
<bullet> Consumer use in automotive degreasers (gasket remover,
transmission cleaners, carburetor);
<bullet> Consumer use in aerosol and non-aerosol lubricants and
greases, consumer use in cold pipe insulation;
<bullet> Consumer use in aerosol and non-aerosol lubricants/greases
and aerosol and non-aerosol degreaser/cleaners;
<bullet> Consumer use in cold pipe insulation;
<bullet> Consumer use in crafting glue and cement/concrete;
<bullet> Consumer use in anti-adhesive agent--anti-spatter welding
aerosol; and
<bullet> Consumer use in carbon remover and brush cleaner.
Under the proposed whole chemical approach to the methylene
chloride risk determination, the unreasonable risk from methylene
chloride would continue to be driven by risk from those same condition
of use. In addition, by removing the assumption of PPE use in making
the whole chemical risk determination for methylene chloride, five
conditions of use in addition to the original 47 would drive the draft
unreasonable risk determination:
<bullet> Manufacturing (domestic manufacture);
<bullet> Processing as a reactant;
<bullet> Processing: recycling;
<bullet> Industrial and commercial use as laboratory chemical; and
<bullet> Disposal.
Overall, 52 conditions of use out of the 53 EPA evaluated would
drive the methylene chloride whole chemical unreasonable risk
determination.
III. Revision of the June 2020 Risk Evaluation
A. Why is EPA proposing to revise the risk determination for the
methylene chloride risk evaluation?
EPA is proposing to revise the 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, 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 the draft revision:
(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.
[[Page 39830]]
B. What are the draft revisions?
EPA is releasing a draft revision of the risk determination for the
methylene chloride risk evaluation pursuant to TSCA section 6(b). Under
the draft revised determination, EPA preliminarily concludes that
methylene chloride, as evaluated in the risk evaluation as a whole,
presents an unreasonable risk of injury to health under its conditions
of use. This revision would replace the previous unreasonable risk
determinations made for methylene chloride by individual conditions of
use, supersede the determinations (and withdraw 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 clarify the lack
of reliance on assumed use of PPE as part of the risk determination.
These draft 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 changed except to the extent that statements about PPE assumptions
in section 2.4.1.1 (Consideration of Engineering Controls and PPE) of
the methylene chloride risk evaluation would be superseded. The
discussion of the issues in this notice and in the accompanying draft
revision to the risk determination would supersede any conflicting
statements in the prior executive summary and section 2.4.1.1 from the
methylene chloride risk evaluation and the response to comments
document (Refs. 2 and 10). Additional policy changes to other chemical
risk evaluations, including any consideration of potentially exposed or
susceptible subpopulations and/or inclusion of additional exposure
pathways, are not necessarily reflected in these draft revisions to the
risk determination.
C. Will the draft revised risk determination be peer reviewed?
The risk determination (section 5 in the June 2020 risk evaluation)
was not part of the scope of the peer reviews of the methylene chloride
risk evaluation by the Science Advisory Committee on Chemicals (SACC).
Thus, consistent with that approach, EPA does not intend to conduct
peer review for the draft revised unreasonable risk determination of
the methylene chloride risk evaluation because no technical or
scientific changes will be made to the hazard or exposure assessments
or the risk characterization.
D. What are the next steps for finalizing revisions to the risk
determination?
EPA will review and consider public comment received on the draft
revised risk determination for the methylene chloride risk evaluation
and, after considering those public comments, issue the revised final
methylene chloride risk determination. If finalized as drafted, EPA
would also issue 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. This final revised risk determination would
supersede the June 2020 risk determinations of no unreasonable risk.
Consistent with the statutory requirements of TSCA section 6(a), the
Agency would then propose risk management actions to address the
unreasonable risk determined in the methylene chloride risk evaluation.
IV. 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. Draft Revised Unreasonable Risk Determination for methylene
chloride, Section 5, July 2022.
2. EPA. Risk Evaluation for Methylene Chloride (MC). EPA Document
#740-R1-8010. January 2021. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0107">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0107</a>.
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. <a href="https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations">https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations</a>.
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, July 20, 2017 (FRL-9964-38).
10. EPA. Summary of External Peer Review and Public Comments and
Disposition for Methylene Chloride (MC); Response to Support Risk
Evaluation of Methylene Chloride (MC). EPA Document# EPA-740-R2-
0022. June 2020. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0083">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0083</a>.
11. Occupational Safety and Health Administration. Permissible
Exposure Limits--Annotated Tables. Accessed June 13, 2022. <a href="https://www.osha.gov/annotated-pels">https://www.osha.gov/annotated-pels</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: June 28, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-14163 Filed 7-1-22; 8:45 am]
BILLING CODE 6560-50-P
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