[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52766-52773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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the 1970's are described by OSHA as being ``outdated and inadequate for 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 https://www.regulations.gov. 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 https://www.epa.gov/dockets.

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: [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. 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 
https://www.regulations.gov 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 https://www.epa.gov/dockets/commenting-epa-dockets.

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:
     Manufacturing (Domestic Manufacture);
     Manufacturing (Import, including loading/unloading and 
repackaging);
     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 in laboratory chemicals;
     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, and paints and coatings);
     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.
    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

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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. https://www.epa.gov/sites/default/files/2020-10/documents/1_ccl4_risk_evaluation_for_carbon_tetrachloride.pdf. 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. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0064.
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. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
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).

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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. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0499-0062.
12. Occupational Safety and Health Administration. Permissible 
Exposure Limits--Annotated Tables. Accessed June 13, 2022. https://www.osha.gov/annotated-pels.

    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