[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described by OSHA as being ``outdated and inadequate for ensuring 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]
BILLING CODE 6560-50-P


