[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Notices]
[Pages 79303-79309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28041]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0733; FRL-9948-02-OCSPP]
Carbon Tetrachloride; Revision to Toxic Substances Control Act
(TSCA) Risk Determination; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final revision to the risk determination for the
carbon tetrachloride risk evaluation issued under the Toxic Substances
Control Act (TSCA). The 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. EPA determined 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 revised risk determination does not reflect an
assumption that workers always appropriately wear personal protective
equipment (PPE). EPA understands that there could be adequate
occupational safety protections in place at certain workplace
locations; however, not assuming use of PPE reflects EPA's recognition
that unreasonable risk may exist for subpopulations of workers that may
be highly exposed because they are not covered by Occupational Safety
and Health Administration (OSHA) standards, or their employers are out
of compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are
described by OSHA as being ``outdated and inadequate for ensuring
protection of worker health,'' or because EPA finds unreasonable risk
for purposes of TSCA notwithstanding OSHA requirements. This revision
supersedes the condition of use-specific no unreasonable risk
determinations in the November 2020 Carbon Tetrachloride Risk
Evaluation and withdraws the associated TSCA order included in the
November 2020 Carbon Tetrachloride Risk Evaluation.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0733, is available online
at https://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
[[Page 79304]]
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Claudia Menasche, Office of
Pollution Prevention and Toxics (7404M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-3391; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to those involved in the manufacture, processing,
distribution, use, disposal, and/or the assessment of risks involving
chemical substances and mixtures. You may be potentially affected by
this action if you manufacture (defined under TSCA to include import),
process (including recycling), distribute in commerce, use or dispose
of carbon tetrachloride. Since other entities may also be interested in
this revision to the risk determination, EPA has not attempted to
describe all the specific entities that may be affected by this action.
B. What is EPA's authority for taking this action?
TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
(PESS) identified as relevant to the risk evaluation by the
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A).
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and
minimum requirements applicable to this process, including provisions
that provide instruction on chemical substances that must undergo
evaluation, the minimum components of a TSCA risk evaluation, and the
timelines for public comment and completion of the risk evaluation.
TSCA also requires that EPA operate in a manner that is consistent with
the best available science, make decisions based on the weight of the
scientific evidence, and consider reasonably available information. 15
U.S.C. 2625(h), (i), and (k).
The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
EPA has inherent authority to reconsider previous decisions and to
revise, replace, or repeal a decision to the extent permitted by law
and supported by reasoned explanation. FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to
such authority, EPA has reconsidered and is now finalizing a revised
risk determination for CTC.
C. What action is EPA taking?
EPA is announcing the availability of the final revision to the
risk determination for the carbon tetrachloride risk evaluation issued
under TSCA that published in November 2020 (Ref. 1). In August 2022,
EPA sought public comment on the draft revisions (87 FR 52766, August
29, 2022). EPA appreciates the public comments received on the draft
revision to the carbon tetrachloride risk determination. After review
of these comments and consideration of the specific circumstances of
carbon tetrachloride, EPA concludes that 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 is revising and replacing Section
5 of the November 2020 Carbon Tetrachloride Risk Evaluation (Ref. 2)
where the findings of unreasonable risk to health were previously made
for the individual conditions of use evaluated. EPA is also withdrawing
the previously issued TSCA section 6(i)(l) order for two conditions of
use previously determined not to present unreasonable risk which was
included in Section 5.4.1 of the November 2020 Carbon Tetrachloride
Risk Evaluation (Ref. 2).
This final revision to the carbon tetrachloride risk determination
is consistent with EPA's plans to revise specific aspects of the first
ten TSCA chemical risk evaluations to ensure that the risk evaluations
better align with TSCA's objective of protecting health and the
environment. As a result of this revision, removing the assumption that
workers always and appropriately wear PPE (see Unit II.C.) would not
alter the conditions of use that drive the unreasonable risk
determination for carbon tetrachloride. However, without the assumed
use of PPE, inhalation exposures to workers now also drive the
unreasonable risk and, in addition to there being risks of cancer
effects from dermal exposures, risks of non-cancer effects
(specifically liver toxicity) from dermal exposures are now also
driving the unreasonable risk. In addition, the November 2020 Carbon
Tetrachloride Risk Evaluation contained a typographical error in the
acute dermal point of departure (POD). This error was corrected in a
memorandum made available to the public in the docket July 2022 and the
changes to the risk estimates for acute dermal exposures are reflected
in the revision to the risk determination (Ref. 14). The corrections do
not alter the conditions of use that drive the unreasonable risk
determination for carbon tetrachloride. EPA is not making condition-of-
use-specific risk determinations for those conditions of use, and for
purposes of TSCA section 6(i), EPA is not issuing a final order under
TSCA section 6(i)(1) for the conditions of use that do not drive the
unreasonable risk and does not consider the revised risk determination
to constitute a final agency action at this point in time. Overall, 13
conditions of use out of 15 EPA evaluated 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 November 2020 Carbon Tetrachloride Risk Evaluation
(Ref. 2).
[[Page 79305]]
II. Background
A. Why is EPA re-issuing the risk determination for the carbon
tetrachloride risk evaluation conducted under TSCA?
In accordance with Executive Order 13990 (``Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis'') and other Administration priorities (Refs. 3, 4, 5, and 6),
EPA reviewed the risk evaluations for the first ten chemical
substances, including 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.
7). Following a review of specific aspects of the November 2020 Carbon
Tetrachloride Risk Evaluation (Ref. 2) and after considering comments
received on a draft revised risk determination for carbon
tetrachloride, EPA has determined 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 for carbon tetrachloride under the statute
and implementing regulations. In addition, EPA's final risk
determination is explicit insofar as it does not rely on assumptions
regarding the use of PPE in making the unreasonable risk determination
under TSCA section 6, even though some facilities might be using PPE as
one means to reduce worker exposures; rather, the use of PPE as a means
of addressing unreasonable risk will be considered during risk
management, as appropriate.
Separately, EPA is conducting a screening approach to assess 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 final risk evaluation (see section 1.4.3 of the
November 2020 Carbon Tetrachloride Risk Evaluation). 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 determine if
there may be risks that were unaccounted for in the carbon
tetrachloride risk evaluation.
The screening-level approach has gone through public comment and
independent external peer review through the SACC. The Agency received
the final peer review report on May 18, 2022, and has reviewed public
comments and SACC comments. EPA expects to describe its findings
regarding the chemical-specific application of this screening-level
approach in the forthcoming proposed rule under TSCA section 6(a) for
carbon tetrachloride.
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 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.
As explained in the Federal Register document announcing the
availability of the draft revised risk determination for carbon
tetrachloride (87 FR 52766, August 29, 2022 (FRL-9948-01-OCSPP)), the
proposed Risk Evaluation Procedural Rule (Ref. 8) was premised on the
whole chemical approach to making unreasonable risk determinations. In
that proposed rule, EPA acknowledged a lack of specificity in statutory
text that might lead to different views about whether the statute
compelled EPA's risk evaluations to address all conditions of use of a
chemical substance or whether EPA had discretion to evaluate some
subset of conditions of use (i.e., to scope out some manufacturing,
processing, distribution in commerce, use, or disposal activities), but
also stated that ``EPA believes the word `the' [in TSCA section
6(b)(4)(A)] is best interpreted as calling for evaluation that
considers all conditions of use.'' The proposed rule, however, was
unambiguous on the point that unreasonable risk determinations would be
for the chemical substance as a whole, even if based on a subset of
uses. See Ref. 8 at pages 7565-66 (``TSCA section 6(b)(4)(A) specifies
that a risk evaluation must determine whether `a chemical substance'
presents an unreasonable risk of injury to health or the environment
`under the conditions of use.' The evaluation is on the chemical
substance--not individual conditions of use--and it must be based on
`the conditions of use.' In this context, EPA believes the word `the'
is best interpreted as calling for evaluation that considers all
conditions of use.''). In the proposed regulatory text, EPA proposed to
determine whether the chemical substance presents an unreasonable risk
of injury to health or the environment under the conditions of use.
(Ref. 8 at 7480.)
The final Risk Evaluation Procedural Rule stated (82 FR 33726, July
20, 2017 (FRL-9964-38)) (Ref. 9): ``As part of the risk evaluation, EPA
will determine whether the chemical substance presents an unreasonable
risk of injury to health or the environment under each condition of
uses [sic] within the scope of the risk evaluation, either in a single
decision document or in multiple decision documents'' (40 CFR 702.47).
For the unreasonable risk determinations in the first ten risk
evaluations, EPA applied this provision by making individual risk
determinations for each condition of use evaluated as part of each risk
evaluation document (i.e., the condition-of-use-specific approach to
risk determinations). That approach was based on one particular passage
in the preamble to the final Risk Evaluation Rule which stated that EPA
will make individual risk determinations for all conditions of use
identified in the scope. (Ref. 9 at 33744).
In contrast to this portion of the preamble of the final Risk
Evaluation Rule, the regulatory text itself and other statements in the
preamble reference a risk determination for the chemical substance
under its conditions of use, rather than separate risk determinations
for each of the conditions of use of a chemical substance. In the key
regulatory provision excerpted previously from 40 CFR 702.47, the text
explains that ``[a]s part of the risk evaluation, EPA will determine
whether the chemical substance presents an
[[Page 79306]]
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. 9 at 33729).
Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk
evaluation regulation to also allow the Agency to issue whole-chemical
risk determinations. Either approach is permissible under the
regulation. A panel of the Ninth Circuit Court of Appeals also
recognized the ambiguity of the regulation on this point. Safer
Chemicals v. EPA, 943 F.3d. 397, 413 (9th Cir. 2019) (holding a
challenge about ``use-by-use risk evaluations [was] not justiciable
because it is not clear, due to the ambiguous text of the Risk
Evaluation Rule, whether the Agency will actually conduct risk
evaluations in the manner Petitioners fear'').
EPA plans to consider the appropriate approach for each chemical
substance risk evaluation on a case-by-case basis, taking into account
considerations relevant to the specific chemical substance in light of
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's
ability to evaluate and manage unreasonable risk from individual
chemical substances. EPA believes this is a reasonable approach under
TSCA and the Agency's implementing regulations.
With regard to the specific circumstances of carbon tetrachloride,
EPA has determined 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 a substantial number of conditions of use
(spanning across most aspects of the chemical lifecycle-from
manufacturing (including import), processing, industrial and commercial
use, and disposal) for workers and occupational non-users and risk of
severe health effects (specifically cancer and liver toxicity)
associated with carbon tetrachloride 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 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 November 2020 Carbon
Tetrachloride Risk Evaluation (Ref. 2)) follow the issuance of a draft
revision to the TSCA carbon tetrachloride unreasonable risk
determination (87 FR 52766, August 29, 2022) and the receipt of public
comment. A response to comments document is also being issued with the
final revised unreasonable risk determination for carbon tetrachloride
(Ref. 10). The revisions to the unreasonable risk determination are
based on the existing risk characterization section of the November
2020 Carbon Tetrachloride Risk Evaluation (Ref. 2) (Section 4) and do
not involve additional technical or scientific analysis. The discussion
of the issues in this Federal Register document and in the accompanying
final revised risk determination for carbon tetrachloride supersede any
conflicting statements in the November 2020 Carbon Tetrachloride Risk
Evaluation (Ref. 2) and the earlier response to comments document (Ref.
11). EPA views the peer reviewed hazard and exposure assessments and
associated risk characterization as robust and upholding the standards
of best available science and weight of the scientific evidence per
TSCA sections 26(h) and (i).
For purposes of TSCA section 6(i), EPA is making a risk
determination on carbon tetrachloride as a whole chemical. Under the
revised approach, the ``whole chemical'' risk determination for carbon
tetrachloride supersedes the no unreasonable risk determinations for
carbon tetrachloride that were premised on a condition-of-use-specific
approach to determining unreasonable risk and also contains an order
withdrawing the TSCA section 6(i)(1) order in Section 5.4.1 of the
November 2020 Carbon Tetrachloride Risk Evaluation (Ref. 2).
C. What revision is EPA now making final 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 workers were provided and always used PPE in a
manner that achieves the stated assigned protection factor (APF) for
respiratory protection, or used impervious gloves for dermal
protection. In support of this assumption, EPA used reasonably
available information such as public comments indicating that some
employers, particularly in the industrial setting, provide PPE to their
employees and follow established worker protection standards (e.g.,
OSHA requirements for protection of workers).
For the November 2020 Carbon Tetrachloride Risk Evaluation (Ref.
2), EPA assumed, based on reasonably available information 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. In the November 2020 Carbon Tetrachloride Risk Evaluation, 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 and properly use PPE. However, this does not mean that
EPA questions the veracity of public comments which describe
occupational safety practices often followed by industry. EPA believes
it is appropriate when conducting risk evaluations under TSCA to
evaluate the levels of risk present in baseline scenarios where PPE is
not assumed to be used by workers. This approach of not assuming PPE
use by workers considers the risk to potentially exposed or susceptible
subpopulations of workers who may not
[[Page 79307]]
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 November 2020 Carbon Tetrachloride
Risk Evaluation (Ref. 2) characterized risk to workers both with and
without the use of PPE. By characterizing risks using scenarios that
reflect different levels of mitigation, EPA risk evaluations can help
inform potential risk management actions by providing information that
could be used during risk management to tailor risk mitigation
appropriately to address any unreasonable risk identified, or to ensure
that applicable OSHA requirements or industry or sector best practices
that address the unreasonable risk are required for all potentially
exposed and susceptible subpopulations (including self-employed
individuals and public sector workers who are not covered by an OSHA
State Plan).
When undertaking unreasonable risk determinations as part of TSCA
risk evaluations, however, EPA does not believe it is appropriate to
assume as a general matter that an applicable OSHA requirement or
industry practice related to PPE use is consistently and always
properly applied. Mitigation scenarios included in the EPA risk
evaluation (e.g., scenarios considering use of various PPE) likely
represent what is happening already in some facilities. However, the
Agency cannot assume that all facilities have adopted these practices
for the purposes of making the TSCA risk determination (Ref. 12).
Therefore, EPA is making a determination of unreasonable risk for
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. 13), or
because EPA finds unreasonable risk for purposes of TSCA
notwithstanding OSHA requirements.
In accordance with this approach, EPA is finalizing the revision to
the 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) will be considered during the risk management
phase, as appropriate. This represents a change from the approach taken
in the November 2020 Carbon Tetrachloride Risk Evaluation (Ref. 2). As
a general matter, when undertaking risk management actions, EPA intends
to strive for consistency with applicable OSHA requirements and
industry best practices, including appropriate application of the
hierarchy of controls, to the extent that applying those measures would
address the identified unreasonable risk, including unreasonable risk
to potentially exposed or susceptible subpopulations. Consistent with
TSCA section 9(d), EPA will consult and coordinate TSCA activities with
OSHA and other relevant Federal agencies for the purpose of achieving
the maximum applicability of TSCA while avoiding the imposition of
duplicative requirements. Informed by the mitigation scenarios and
information gathered during the risk evaluation and risk management
process, the Agency might propose rules that require risk management
practices that may be already common practice in many or most
facilities. Adopting clear, comprehensive regulatory standards will
foster compliance across all facilities (ensuring a level playing
field) and assure protections for all affected workers, especially in
cases where current OSHA standards may not apply or be sufficient to
address the unreasonable risk.
Removing the assumption that workers always and appropriately wear
PPE in making the whole chemical risk determination for carbon
tetrachloride does 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 causes inhalation exposures to
workers to also drive the unreasonable risk and, in addition to there
being risks of cancer effects from dermal exposures, risks of non-
cancer effects (specifically liver toxicity, including risk associated
with acute dermal exposures identified after the July 2022 corrections
to the risk estimates (Ref. 14)) from dermal exposures are now also
driving the unreasonable risk. The finalized revision to the carbon
tetrachloride risk determination clarifies that EPA does not rely on
the assumed use of PPE when making the risk determination for the whole
substance; rather, the use of PPE as a means of addressing unreasonable
risk will be considered during risk management as appropriate.
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, adhesives, asphalt, paints
and coatings, and elimination of nitrogen trichloride in the production
of chlorine and caustic soda. The use of carbon tetrachloride for non-
feedstock uses (i.e., process agent, laboratory chemical) is regulated
in accordance with the Montreal Protocol.
E. What conclusions is EPA finalizing today in the revised TSCA risk
evaluation based on the whole chemical approach and not assuming the
use of PPE?
EPA determined that carbon tetrachloride presents an unreasonable
risk to health under the conditions of use. EPA's unreasonable risk
[[Page 79308]]
determination for carbon tetrachloride as a chemical substance is
driven by risks associated with the following conditions of use,
considered singularly or in combination with other exposures:
Manufacturing (Domestic Manufacture);
Manufacturing (Import);
Processing as a reactant in the production of
hydrochlorofluorocarbon, hydrofluorocarbon, hydrofluoroolefin, and
perchloroethylene;
Processing: Incorporation into formulation, mixtures or
reaction products (petrochemicals-derived manufacturing; agricultural
products manufacturing; other basic organic and inorganic chemical
manufacturing);
Processing: Repackaging for use as a laboratory chemical;
Processing: Recycling;
Industrial/commercial use as an industrial processing aid
in the manufacture of petrochemicals-derived products and agricultural
products;
Industrial/commercial use in the manufacture of other
basic chemicals (including chlorinated compounds used in solvents,
adhesives, asphalt, paints and coatings, and elimination of nitrogen
trichloride in the production of chlorine and caustic soda);
Industrial/commercial use in metal recovery;
Industrial/commercial use as an additive;
Industrial/commercial use in specialty uses by the
Department of Defense;
Industrial/commercial use as a laboratory chemical; and
Disposal.
EPA notes that the names of some of these conditions of use have
been slightly modified from the draft revised risk determination for
clarity and consistency with Table 1-4 of the November 2020 Carbon
Tetrachloride Risk Evaluation. The following conditions of use do not
drive EPA's unreasonable risk determination for carbon tetrachloride:
Processing as a reactant/intermediate in reactive ion
etching; and
Distribution in commerce.
EPA is not making condition of use-specific risk determinations for
these conditions of use, is not issuing a final order under TSCA
section 6(i)(1) for these conditions of use and does not consider the
revised risk determination for carbon tetrachloride to constitute a
final agency action at this point in time.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose a risk management regulatory action to the extent
necessary so that carbon tetrachloride no longer presents an
unreasonable risk. EPA expects to focus its risk management action on
the conditions of use that drive the unreasonable risk. However, it
should be noted that, under TSCA section 6(a), EPA is not limited to
regulating the specific activities found to drive unreasonable risk and
may select from among a suite of risk management requirements in
section 6(a) related to manufacture (including import), processing,
distribution in commerce, commercial use, and disposal as part of its
regulatory options to address the unreasonable risk. As a general
example, EPA may regulate upstream activities (e.g., processing,
distribution in commerce) to address downstream activities (e.g.,
commercial uses) driving unreasonable risk, even if the upstream
activities do not drive the unreasonable risk.
III. Summary of Public Comments
EPA received a total of 12 public comments on the August 29, 2022,
draft revised risk determination for carbon tetrachloride during the
comment period that ended September 28, 2022. Commenters included trade
organizations, industry stakeholders, environmental groups, and non-
governmental health advocacy organizations. A separate document that
summarizes all comments submitted and EPA's responses to those comments
has been prepared and is available in the docket for this notice (Ref.
10).
IV. Revision of the November 2020 Carbon Tetrachloride Risk Evaluation
A. Why is EPA revising the risk determination for the carbon
tetrachloride risk evaluation?
EPA is finalizing the revised 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. 3, 4, 5, and 6). EPA is
revising specific aspects of the first ten TSCA existing chemical risk
evaluations in order to ensure that the risk evaluations better align
with TSCA's objective of protecting health and the environment. For the
carbon tetrachloride risk evaluation, this includes: (1) Making the
risk determination in this instance based on the whole chemical
substance instead of by individual conditions of use and (2)
Emphasizing that EPA does not rely on the assumed use of PPE when
making the risk determination.
B. What are the revisions?
EPA is now finalizing the revised risk determination for the
November 2020 Carbon Tetrachloride Risk Evaluation (Ref. 2) pursuant to
TSCA section 6(b). Under the revised determination (Ref. 1), EPA
concludes that carbon tetrachloride, as evaluated in the risk
evaluation as a whole, presents an unreasonable risk of injury to
health when evaluated under its conditions of use. This revision
replaces the previous unreasonable risk determinations made for carbon
tetrachloride by individual conditions of use, supersedes the
determinations (and withdraws the associated order) of no unreasonable
risk for the conditions of use identified in the TSCA section 6(i)(1)
no unreasonable risk order, and clarifies the lack of reliance on
assumed use of PPE as part of the risk determination.
These revisions do not alter any of the underlying technical or
scientific information that informs the risk characterization, and as
such the hazard, exposure, and risk characterization sections are not
changed. The 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 memorandum corrected a typographical error in the acute
dermal point of departure (POD) and the risk estimates based on that
POD in the November 2020 Carbon Tetrachloride Risk Evaluation (Ref.
14). The discussion of the issues in this Notice and in the
accompanying final revision to the risk determination supersede any
conflicting statements in the prior executive summary from the November
2020 Carbon Tetrachloride Risk Evaluation (Ref. 2) and the response to
comments document (Ref. 11).
The revised unreasonable risk determination for carbon
tetrachloride includes additional explanation of how the risk
evaluation characterizes the applicable OSHA requirements, or industry
or sector best practices, and also clarifies that no additional
analysis was done, and the risk determination is based on the risk
characterization (Section 4) of the November 2020 Carbon Tetrachloride
Risk Evaluation (Ref. 2) and reflects the memorandum correcting risk
estimates for acute dermal exposures (Ref. 14).
C. Will the revised risk determination be peer reviewed?
The risk determination (Section 5 of the November 2020 Carbon
Tetrachloride Risk Evaluation (Ref. 2))
[[Page 79309]]
was not part of the scope of the Science Advisory Committee on
Chemicals (SACC) peer review of the carbon tetrachloride risk
evaluation. Thus, consistent with that approach, EPA did not conduct
peer review of the final revised unreasonable risk determination for
the carbon tetrachloride risk evaluation because no technical or
scientific changes were made to the hazard or exposure assessments or
the risk characterization.
V. Order Withdrawing Previous Order Regarding Unreasonable Risk
Determinations for Certain Conditions of Use
EPA is also issuing a new order to withdraw the TSCA Section
6(i)(1) no unreasonable risk order issued in Section 5.4.1 of the
November 2020 Carbon Tetrachloride Risk Evaluation (Ref. 2). This final
revised risk determination supersedes the condition of use-specific no
unreasonable risk determinations in the November 2020 Carbon
Tetrachloride Risk Evaluation (Ref. 2). The order contained in Section
5.5 of the revised risk determination (Ref. 1) withdraws the TSCA
section 6(i)(1) order contained in Section 5.4.1 of the November 2020
Carbon Tetrachloride Risk Evaluation (Ref. 2). Consistent with the
statutory requirements of section 6(a), the Agency will propose risk
management action to address the unreasonable risk determined in the
carbon tetrachloride risk evaluation.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Unreasonable Risk Determination for Carbon Tetrachloride.
December 2022.
2. EPA. Risk Evaluation for Carbon Tetrachloride. November 2020. EPA
Document No. EPA-740-R1-8014. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0047.
3. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
4. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
5. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
6. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
7. EPA. Press Release; EPA Announces Path Forward for TSCA Chemical
Risk Evaluations. June 2021. https://www.epa.gov//epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
7562, January 19, 2017) (FRL-9957-75).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
33726, 33744, July 20, 2017).
10. EPA. Response to Public Comments to the Revised Unreasonable
Risk Determination; Carbon Tetrachloride. December 2022.
11. EPA. Summary of External Peer Review and Public Comments and
Disposition for Carbon Tetrachloride. October 2020. Available at:
https://www.regulations.gov//HQ-OPPT-2019-0499-0062.
12. Occupational Safety and Health Administration (OSHA). Top 10
Most Frequently Cited Standards for Fiscal Year 2021 (Oct. 1, 2020,
to Sept. 30, 2021). Accessed October 13, 2022. https://www.osha.gov/citedstandards.
13. OSHA. Permissible Exposure Limits--Annotated Tables. Accessed
June 13, 2022. https://www.osha.gov/pels.
14. EPA. Correction of Dermal Acute Hazard and Risk Values in the
Final Risk Evaluation for Carbon Tetrachloride. Memorandum. July 27,
2022. Docket EPA-HQ-OPPT-2019-0499-0064. https://www.regulations.gov//EPA-HQ-OPPT-2019-0499-0064.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 20, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-28041 Filed 12-23-22; 8:45 am]
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