Notice2022-18535
Carbon Tetrachloride; Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment
Primary source
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Published
August 29, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and requesting public comment on a draft revision to the risk determination for the carbon tetrachloride risk evaluation issued under the Toxic Substances Control Act (TSCA). The draft revision to the carbon tetrachloride 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 carbon tetrachloride, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. In addition, this draft 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 the standards set by the Occupational Safety and Health Administration (OSHA), 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of OSHA's chemical-specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being "outdated and inadequate for ensuring protection of worker health." This revision, when final, would supersede the condition of use-specific no unreasonable risk determinations in the 2020 Carbon Tetrachloride Risk Evaluation (and withdraw the associated order) and would make a revised determination of unreasonable risk for carbon tetrachloride as a whole chemical substance.
Full Text
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52766-52773]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18535]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0733; FRL-9948-01-OCSPP]
Carbon Tetrachloride; 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 requesting public comment on a draft revision to
the risk determination for the carbon tetrachloride risk evaluation
issued under the Toxic Substances Control Act (TSCA). The draft
revision to the carbon tetrachloride 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 carbon tetrachloride, as a whole chemical substance, presents an
unreasonable risk of injury to health when evaluated under its
conditions of use. In addition, this draft revised risk determination
does not reflect an assumption that all workers always appropriately
wear personal protective equipment (PPE). EPA understands that there
could be
[[Page 52767]]
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 the standards set by the
Occupational Safety and Health Administration (OSHA), 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.'' This revision, when final,
would supersede the condition of use-specific no unreasonable risk
determinations in the 2020 Carbon Tetrachloride Risk Evaluation (and
withdraw the associated order) and would make a revised determination
of unreasonable risk for carbon tetrachloride as a whole chemical
substance.
DATES: Comments must be received on or before September 28, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0733, 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: Claudia Menasche, Office of
Pollution Prevention and Toxics (7404T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-3391; email address: <a href="/cdn-cgi/l/email-protection#92fff7fcf3e1f1faf7bcf1fef3e7f6fbf3d2f7e2f3bcf5fde4"><span class="__cf_email__" data-cfemail="7b161e151a0818131e5518171a0e1f121a3b1e0b1a551c140d">[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#1d494e5e5c30557269717473785d786d7c337a726b"><span class="__cf_email__" data-cfemail="51050212107c193e253d383f34113421307f363e27">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
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 carbon tetrachloride. 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 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). Pursuant to
such authority, EPA is reconsidering the risk determinations in the
2020 Carbon Tetrachloride Risk Evaluation (Ref. 1).
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
carbon tetrachloride under TSCA (Ref. 2). 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 carbon
tetrachloride, 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 carbon tetrachloride 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 carbon
tetrachloride 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 2 conditions of use
previously determined not to present unreasonable risk.
This revision to section 5 (Ref. 2) would be 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. Under the
draft revision, the same 13 conditions of use identified in the 2020
Carbon Tetrachloride Risk Evaluation (Ref. 1) as presenting
unreasonable risk would continue to drive the unreasonable risk
determination for carbon tetrachloride. Removing the assumption that
workers always and appropriately wear PPE (see Unit II.C.) when making
the whole chemical risk determination for carbon tetrachloride would
not alter the conditions of use
[[Page 52768]]
that drive the unreasonable risk determination for carbon
tetrachloride. However, without the assumed use of PPE, inhalation
exposures to workers would now also drive the unreasonable risk and
dermal exposures would also drive the unreasonable risk due to non-
cancer effects (specifically liver toxicity). In addition, the 2020
Carbon Tetrachloride Risk Evaluation (Ref. 1) contained a typographical
error in the acute dermal point of departure (POD). This error was
corrected in an errata made available to the public in the docket in
July 2022 and the changes to the risk estimates for acute dermal
exposures are reflected in the draft revision to the risk determination
(Ref. 3). The corrections do not alter the conditions of use that drive
the unreasonable risk determination for carbon tetrachloride. Overall,
13 conditions of use out of 15 EPA evaluated would drive the carbon
tetrachloride whole chemical unreasonable risk determination due to
risks identified for human health. The full list of the conditions of
use evaluated for the carbon tetrachloride TSCA risk evaluation is in
Table 1-4 of the 2020 Carbon Tetrachloride Risk Evaluation (Ref. 1).
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="https://www.regulations.gov">https://www.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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. Why is EPA re-issuing the risk determination for the carbon
tetrachloride 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 (PV 29), cyclic aliphatic
bromide cluster (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 carbon tetrachloride
in 2020 (Ref. 1). 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. 4) and other
Administration priorities (Refs. 5, 6, and 7), EPA reviewed the risk
evaluations for the first ten chemical substances, including carbon
tetrachloride, 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.
8). To that end, EPA is reconsidering two key aspects of the risk
determinations for carbon tetrachloride. First, following a review of
specific aspects of the 2020 Carbon Tetrachloride Risk Evaluation (Ref.
1), EPA proposes that making an unreasonable risk determination for
carbon tetrachloride 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 carbon tetrachloride 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 worker 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 carbon tetrachloride
the exposure pathways that were or could be regulated under another EPA
administered statute were excluded from the 2020 Carbon Tetrachloride
Risk Evaluation (see section 1.4.3. in Ref. 1). This resulted in the
ambient air and ambient/drinking water pathways for carbon
tetrachloride not being assessed. 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 2020 Carbon Tetrachloride
Risk Evaluation (Ref. 1). 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 carbon tetrachloride 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 carbon
tetrachloride. 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 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 carbon tetrachloride 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. 9). 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
[[Page 52769]]
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. 9).
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. 9 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. 9 at pg. 7480).
The final risk evaluation procedural rule (Ref. 10) 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 as part of 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 determinations for all conditions of use identified in the scope.
(Ref. 10 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 above 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. 10,
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. 10 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 carbon tetrachloride,
EPA proposes that a whole chemical approach is appropriate for carbon
tetrachloride in order to protect health. The whole chemical approach
is appropriate for carbon tetrachloride 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, and disposal) for
health of workers and occupational non-users and the health effects
associated with carbon tetrachloride exposures are irreversible
(specifically cancer and liver toxicity). 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
would drive the unreasonable risk; therefore, it is appropriate for the
Agency to make a determination for carbon tetrachloride 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 document and in the accompanying draft
revision to the risk determination for carbon tetrachloride supersede
any conflicting statements in the prior carbon tetrachloride risk
evaluation (Ref. 1) and the related response to comments document (Ref.
11). With respect to the carbon tetrachloride 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
[[Page 52770]]
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 carbon
tetrachloride, including a description of the risks driving the
unreasonable risk determination under the conditions of use for the
chemical substance as a whole (Ref. 2). For purposes of TSCA section
6(i), EPA is making a draft risk determination on carbon tetrachloride
as a whole chemical. Under the proposed revised approach, the ``whole
chemical'' risk determination for carbon tetrachloride would supersede
the no unreasonable risk determinations (and withdraw the associated
order) for carbon tetrachloride 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 2020 Carbon Tetrachloride Risk Evaluation (Ref. 1).
C. What revision does EPA propose about the use of PPE for the carbon
tetrachloride 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 setting, provide PPE to their
employees and follow established worker protection standards (e.g.,
OSHA requirements for protection of workers).
For the 2020 Carbon Tetrachloride Risk Evaluation (Ref. 1), EPA
assumed that workers use PPE, specifically respirators with an APF
ranging from 10 to 50 for 12 conditions of use, and gloves with a PF of
20 for 13 conditions of use. However, in the 2020 Carbon Tetrachloride
Risk Evaluation (Ref. 1), EPA determined that there is unreasonable
risk to these workers even with this assumed PPE use.
EPA is revising the assumption for carbon tetrachloride that
workers always or 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 (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.
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. 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. Consistent with this approach,
the 2020 Carbon Tetrachloride 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 a determination of unreasonable
risk for carbon tetrachloride 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. 12), 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 carbon tetrachloride 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) would be considered during the risk management
phase as appropriate. This would represent a change from the approach
taken in the 2020 Carbon Tetrachloride Risk Evaluation and EPA invites
comments on this draft change to the carbon tetrachloride 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 the identified unreasonable risk, including
[[Page 52771]]
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 carbon
tetrachloride would not result in additional conditions of use to the
original 13 conditions of use that drive the unreasonable risk for
carbon tetrachloride as a whole chemical. However, the impact of
removing the assumption of PPE use would cause inhalation exposures to
workers to also drive the unreasonable risk and dermal exposures would
also drive the unreasonable risk due to non-cancer effects
(specifically liver toxicity, including risk associated with acute
dermal exposures identified after the July 2022 corrections to the risk
estimates (Ref. 3)). 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.
D. What is carbon tetrachloride?
Carbon tetrachloride is a high production volume solvent.
Currently, the vast majority of carbon tetrachloride is used as a
feedstock in the production of hydrochlorofluorocarbons (HCFCs),
hydrofluorocarbons (HFCs) and hydrofluoroolefins (HFOs). EPA has
identified information on the regulated use of carbon tetrachloride as
a process agent in the manufacturing of petrochemicals-derived and
agricultural products and other chlorinated compounds such as
chlorinated paraffins, chlorinated rubber and others that may be used
downstream in the formulation of solvents for degreasing and cleaning,
adhesives, sealants, paints, coatings, rubber, cement and asphalt
formulations. The use of carbon tetrachloride for non-feedstock uses
(i.e., process agent, laboratory chemical) is regulated in accordance
with the Montreal Protocol. The Consumer Product Safety Commission
(CPSC) banned the use of carbon tetrachloride in consumer products
(excluding unavoidable residues not exceeding 10 ppm atmospheric
concentration) in 1970. As a result of CPSC's ban, EPA does not
consider the use of carbon tetrachloride-containing consumer products
produced before 1970 to be known, intended, or reasonably foreseen.
While carbon tetrachloride is used in the manufacturing of other
chlorinated compounds that may be subsequently added to commercially
available products, EPA expects that consumer use of such products
would present only negligible exposure to carbon tetrachloride given
the high volatility of carbon tetrachloride and the extent of reaction
and efficacy of the separation/purification process for purifying final
products. As discussed in section 1.4.2.3, EPA had sufficient basis to
conclude during problem formulation that industrial, commercial, and
consumer uses of carbon tetrachloride in commercially available aerosol
and non-aerosol adhesives and sealants, paints and coatings, and
cleaning and degreasing solvent products would present only de minimis
exposures or otherwise insignificant risks and did not warrant further
evaluation or inclusion in the risk evaluation. Therefore, EPA did not
evaluate hazards or exposures to consumers or bystanders in this risk
evaluation, and there is no unreasonable risk determination for these
populations.
E. What conclusions did EPA reach about the risks of carbon
tetrachloride 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 Carbon Tetrachloride Risk Evaluation (Ref. 1), EPA
determined that carbon tetrachloride presents an unreasonable risk to
health under the following conditions of use:
<bullet> Manufacturing (Domestic Manufacture);
<bullet> Manufacturing (Import, including loading/unloading and
repackaging);
<bullet> Processing: As a reactant in the production of
hydrochlorofluorocarbon, hydrofluorocarbon, hydrofluoroolefin, and
perchloroethylene;
<bullet> Processing: Incorporation into formulation, mixtures or
reaction products (petrochemicals-derived manufacturing; agricultural
products manufacturing; other basic organic and inorganic chemical
manufacturing);
<bullet> Processing: Repackaging for use in laboratory chemicals;
<bullet> Processing: Recycling;
<bullet> Industrial/commercial use as an industrial processing aid
in the manufacture of petrochemicals-derived products and agricultural
products;
<bullet> Industrial/commercial use in the manufacture of other
basic chemicals (including chlorinated compounds used in solvents,
adhesives, asphalt, and paints and coatings);
<bullet> Industrial/commercial use in metal recovery;
<bullet> Industrial/commercial use as an additive;
<bullet> Industrial/commercial use in specialty uses by the
Department of Defense;
<bullet> Industrial/commercial use as a laboratory chemical; and
<bullet> Disposal.
Under the proposed whole chemical approach to the carbon
tetrachloride risk determination, the unreasonable risk from carbon
tetrachloride would continue to be driven by those same conditions of
use (COUs). In addition, by removing the assumption of PPE use in
making the whole chemical risk determination for carbon tetrachloride,
there are no additional conditions of use that would drive the draft
unreasonable risk determination. The same 13 out of the 15 COUs that
EPA evaluated would continue to drive EPA's unreasonable risk
determination, though inhalation exposures to workers would now also
drive the unreasonable risk and dermal exposures would also drive the
unreasonable risk due to non-cancer effects (specifically liver
toxicity), where previously those COUs were identified as presenting
unreasonable risk only from cancer effects from dermal exposures and
cancer and non-cancer effects, for some COUs, to occupational non-users
from inhalation exposures. Overall, 13 out of the 15 COUs that EPA
evaluated would drive the carbon tetrachloride whole chemical
unreasonable risk determination.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose risk management regulatory action to the extent
necessary so that carbon tetrachloride no longer presents an
unreasonable risk. Therefore, it is expected that EPA's risk management
action likely will focus 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
[[Page 52772]]
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. Revision of the 2020 Risk Evaluation
A. Why is EPA proposing to revise the risk determination for the carbon
tetrachloride risk evaluation?
EPA is proposing to revise the risk determination for the carbon
tetrachloride 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. 4, 5, 6, and 7). 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
carbon tetrachloride 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.
B. What are the draft revisions?
Under the revised determination, EPA preliminarily concludes that
carbon tetrachloride, 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 carbon tetrachloride 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 by these revisions. The draft revision to the unreasonable
risk determination considers the corrections to the risk estimates for
acute dermal exposures placed in the docket for the carbon
tetrachloride risk evaluation in July 2022; that errata memorandum
corrected a typographical error in the acute dermal point of departure
(POD) and the risk estimates based on that POD in the 2020 Risk
Evaluation (Ref. 3).
The discussion of the issues in this document and in the
accompanying draft revision to the risk determination would supersede
any conflicting statements in the prior executive summary from the 2020
Carbon Tetrachloride Risk Evaluation and the response to comments
document (Refs. 1 and 11). 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 of the 2020 Carbon Tetrachloride
Risk Evaluation, Ref. 1) was not part of the scope of the peer reviews
of the carbon tetrachloride risk evaluation by the Science Advisory
Committee on Chemicals (SACC). Thus, consistent with that approach, EPA
does not intend to conduct peer review of the draft revised
unreasonable risk determination for the carbon tetrachloride 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 carbon tetrachloride risk evaluation
and, after considering those public comments, issue the revised final
carbon tetrachloride 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 Carbon
Tetrachloride Risk Evaluation (Ref. 1). The final revised risk
determination would supersede the risk determinations of no
unreasonable risk in the 2020 Carbon Tetrachloride Risk Evaluation.
Consistent with the statutory requirements of TSCA section 6(a), the
Agency would then propose risk management actions to address the
unreasonable risk determination in the final revised carbon
tetrachloride risk evaluation.
V. 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. Risk Evaluation for Carbon Tetrachloride (Methane,
Tetrachloro-); CASRN: 56-23-5. EPA Document #740-R1-8014. October
2020. <a href="https://www.epa.gov/sites/default/files/2020-10/documents/1_ccl4_risk_evaluation_for_carbon_tetrachloride.pdf">https://www.epa.gov/sites/default/files/2020-10/documents/1_ccl4_risk_evaluation_for_carbon_tetrachloride.pdf</a>. As announced in
the Federal Register. 85 FR 70147, November 4, 2020 (FRL-10015-51).
2. EPA. Draft Revised Unreasonable Risk Determination for Carbon
Tetrachloride, section 5. July 2022.
3. EPA. Correction of Dermal Acute Hazard and risk Values in the
Final Risk Evaluation for Carbon Tetrachloride. Memorandum. July 27,
2022. Document ID No. EPA-HQ-OPPT-2019-0499-0064. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064</a>.
4. 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.
5. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register. 86 FR 7009, January 25, 2021.
6. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
7. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register. 86 FR 8845, February 10, 2021.
8. 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>.
9. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register. 82 FR
7562, January 18, 2017 (FRL-9957-75).
10. 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).
[[Page 52773]]
11. EPA. Summary of External Peer Review and Public Comments and
Disposition for Carbon Tetrachloride (Methane, Tetrachloro-).
Document ID No. EPA-HQ-OPPT-2019-0499-0062. November 2020. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0062">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0062</a>.
12. 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: August 19, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-18535 Filed 8-26-22; 8:45 am]
BILLING CODE 6560-50-P
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