Document ID: EPA-HQ-OPPT-2016-0737-0126
Agency: epa
Document Type: Notice
Title: Risk Evaluations for Chemical Substances: Trichloroethylene (TCE); Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment
Posted Date: 2022-07-07T04:00Z

[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40520-40526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14478]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0737; FRL-9945-01-OCSPP]

Trichloroethylene (TCE); Draft Revision to Toxic Substances 
Control Act (TSCA) Risk Determination; Notice of Availability and 
Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and seeking public comment on a draft revision to the 
risk determination for the trichloroethylene (TCE) risk evaluation 
issued under TSCA. The draft revision to the TCE 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 TCE, as a whole chemical substance, presents an 
unreasonable risk of injury to health when evaluated under its 
conditions of use. In addition, this revised risk determination does 
not reflect an assumption that all workers always appropriately wear 
personal protective equipment (PPE). EPA understands that there could 
be occupational safety protections in place at workplace locations; 
however, not assuming use of PPE reflects EPA's recognition that 
unreasonable risk may exist for subpopulations of workers that may be 
highly exposed because they are not covered by OSHA standards, or their 
employers are out of compliance with OSHA standards, or because many of 
OSHA's chemical-specific permissible exposure limits largely adopted in 
the 1970's are described by OSHA as being ``outdated and inadequate for 
ensuring protection of worker health.'' This revision, when final, 
would supersede the condition of use-specific no unreasonable risk 
determinations in the November 2020 TCE risk evaluation (and withdraw 
the associated order) and would make a revised determination of 
unreasonable risk for TCE as a whole chemical substance.

DATES: Comments must be received on or before August 8, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA--EPA-HQ-OPPT-2016-0737, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit

[[Page 40521]]

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: 
Katelan McNamara, Office of Pollution Prevention and Toxics (7404M), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4361; 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 TCE, including TCE in products. Since other entities 
may also be interested in this draft revision to the risk 
determination, EPA has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
(PESS) identified as relevant to the risk evaluation by the 
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A). 
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and 
minimum requirements applicable to this process, including provisions 
that provide instruction on chemical substances that must undergo 
evaluation, the minimum components of a TSCA risk evaluation, and the 
timelines for public comment and completion of the risk evaluation. 
TSCA also requires that EPA operate in a manner that is consistent with 
the best available science, make decisions based on the weight of the 
scientific evidence, and consider reasonably available information. 15 
U.S.C. 2625(h), (i), and (k).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other non-risk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    EPA has inherent authority to reconsider previous decisions and to 
revise, replace, or repeal a decision to the extent permitted by law 
and supported by reasoned explanation. FCC v. Fox Television Stations, 
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. 
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to 
such authority, EPA is reconsidering the risk determinations in the 
November 2020 TCE Risk Evaluation.

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 
TCE under TSCA, which was initially published in November 2020 (Ref. 
1). EPA is specifically seeking public comment on the draft revision to 
the risk determination for the risk evaluation where the agency intends 
to determine that TCE, 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 TCE 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 TCE 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 would be consistent with EPA's plans to revise 
specific aspects of the first ten TSCA chemical risk evaluations in 
order to ensure that the risk evaluations better align with TSCA's 
objective of protecting health and the environment. Under the draft 
revision, the same 52 conditions of use would continue to drive the 
unreasonable risk determination for TCE. Removing the assumptions that 
workers always and appropriately wear PPE (see Unit II.C.) when making 
the whole chemical risk determination for TCE would not alter the 
conditions of use that drive the unreasonable risk determination for 
TCE, though additional risks for acute non-cancer and cancer effects 
from inhalation and dermal exposures would also drive the unreasonable 
risk in many of those conditions of use (where previously those 
conditions of use were identified as presenting unreasonable risk for 
chronic non-cancer effects and cancer). Overall, 52 conditions of use 
out of 54 EPA evaluated would drive the TCE whole chemical unreasonable 
risk determination due to risks identified for human health. The full 
list of the conditions of use evaluated for the TCE TSCA risk 
evaluation is in Tables 4-59 and 4-60 of the risk evaluation (Ref. 2).

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
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

[[Page 40522]]

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 http://www.epa.gov/dockets/comments.html.

II. Background

A. Why is EPA re-issuing the risk determination for the TCE 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 (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 TCE in November 2020. 
The risk evaluations included individual unreasonable risk 
determinations for each condition of use evaluated. EPA issued 
determinations that particular conditions of use did not present an 
unreasonable risk by order under TSCA section 6(i)(1).
    In accordance with Executive Order 13990 (Ref. 3) and other 
Administration priorities (Refs. 4, 5, and 6), EPA reviewed the risk 
evaluations for the first ten chemical substances, including TCE, to 
ensure that they meet the requirements of TSCA, including conducting 
decision making in a manner that is consistent with the best available 
science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment (Ref. 
7). To that end, EPA is reconsidering two key aspects of the risk 
determinations for TCE published in November 2020. First, following a 
review of specific aspects of the November 2020 TCE risk evaluation, 
EPA proposes that making an unreasonable risk determination for TCE 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 TCE under 
the statute and implementing regulations. Second, EPA proposes that the 
risk determination should be explicit that it does not rely on 
assumptions regarding the use of personal protective equipment (PPE) in 
making the unreasonable risk determination under TSCA section 6, even 
though some facilities might be using PPE as one means to reduce 
workers exposures; rather, the use of PPE would be considered during 
risk management as appropriate.
    Separately, EPA is conducting a screening approach to assess 
potential risks from the air and water pathways for several of the 
first 10 chemicals, including this chemical. For TCE the exposure 
pathways that were or could be regulated under another EPA administered 
statute were excluded from the final risk evaluation (see section 1.4.2 
of the November 2020 TCE risk evaluation). This resulted in the ambient 
air and ambient water pathways for TCE 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 TCE 
risk evaluation. While this analysis is underway, EPA is not 
incorporating the screening-level approach into this draft revised 
unreasonable risk determination. If the results suggest there is 
additional risk, EPA will determine if the risk management approaches 
being contemplated for TCE 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 TCE. While 
EPA intends to consider and may take additional similar actions on 
other of the first ten chemicals, EPA is taking a chemical-specific 
approach to reviewing the risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of the 
Congressional direction on the need to complete risk evaluations and 
move toward any associated risk management activities in accordance 
with statutory deadlines.

B. What is a whole chemical view of the unreasonable risk determination 
for the TCE risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
    The proposed risk evaluation procedural rule was premised on the 
whole chemical approach to making an unreasonable risk determination 
(Ref. 8). In that proposed rule, EPA acknowledged a lack of specificity 
in statutory text that might lead to different views about whether the 
statute compelled EPA's risk evaluations to address all conditions of 
use of a chemical substance or whether EPA had discretion to evaluate 
some subset of conditions of use (i.e., to scope out some 
manufacturing, processing, distribution in commerce, use, or disposal 
activities), but also stated that ``EPA believes the word `the' (in 
TSCA section 6(b)(4)(A)) is best interpreted as calling for evaluation 
that considers all conditions of use.'' (Ref. 8).
    The proposed rule, however, was unambiguous on the point that an 
unreasonable risk determination would be for the chemical substance as 
a whole, even if based on a subset of uses. (See Ref. 8 at pgs. 7565-
66: ``TSCA section 6(b)(4)(A) specifies that a risk evaluation must 
determine whether `a chemical substance' presents an unreasonable risk 
of injury to health or the environment `under the conditions of use.' 
The evaluation is on the chemical substance--not individual conditions 
of use--and it must be based on `the conditions of use.' In this 
context, EPA believes the word `the' is best interpreted as calling for 
evaluation that considers all conditions of use.''). In the proposed 
regulatory text, EPA proposed to determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use (Ref. 8 at pg. 7480).
    The final risk evaluation procedural rule 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.'' (See also 40 CFR 
702.47). For the unreasonable risk determinations in the first ten risk 
evaluations, EPA applied this provision by making individual risk 
determinations for each condition of use evaluated in each risk 
evaluation (i.e., the condition-of-use-specific approach to risk 
determinations). That approach was based on one particular passage in 
the preamble to the final risk evaluation

[[Page 40523]]

procedural rule, which stated that EPA will make individual risk 
determinations for all conditions of use identified in the scope. (Ref. 
9 at pg. 33744).
    In contrast to this portion of the preamble of the final risk 
evaluation procedural rule, the regulatory text itself and other 
statements in the preamble reference a risk determination for the 
chemical substance under its conditions of use, rather than separate 
risk determinations for each of the conditions of use of a chemical 
substance. In the key regulatory provision excerpted earlier from 40 
CFR 702.47, the text explains that, ``[a]s part of the risk evaluation, 
EPA will determine whether the chemical substance presents an 
unreasonable risk of injury to health or the environment under each 
condition of uses [sic] within the scope of the risk evaluation, either 
in a single decision document or in multiple decision documents'' (Ref. 
9, emphasis added). Other language reiterates this perspective. For 
example, 40 CFR 702.31(a) states that the purpose of the rule is to 
establish the EPA process for conducting a risk evaluation to determine 
whether a chemical substance presents an unreasonable risk of injury to 
health or the environment as required under TSCA section 6(b)(4)(B). 
Likewise, there are recurring references to whether the chemical 
substance presents an unreasonable risk in 40 CFR 702.41(a). See, for 
example, 40 CFR 702.41(a)(6), which explains that the extent to which 
EPA will refine its evaluations for one or more condition of use in any 
risk evaluation will vary as necessary to determine whether a chemical 
substance presents an unreasonable risk. Notwithstanding the one 
preambular statement about condition-of-use-specific risk 
determinations, the preamble to the final rule also contains support 
for a risk determination on the chemical substance as a whole. In 
discussing the identification of the conditions of use of a chemical 
substance, the preamble notes that this task inevitably involves the 
exercise of discretion on EPA's part, and ``as EPA interprets the 
statute, the Agency is to exercise that discretion consistent with the 
objective of conducting a technically sound, manageable evaluation to 
determine whether a chemical substance--not just individual uses or 
activities--presents an unreasonable risk.'' (Ref. 8 at pg. 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue whole-chemical 
risk determinations. Either approach is permissible under the 
regulation. A panel of the Ninth Circuit Court of Appeals also 
recognized the ambiguity of the regulation on this point. Safer 
Chemicals v. EPA, 943 F.3d 397, 413 (9th Cir. 2019) (holding a 
challenge about ``use-by-use risk evaluations [was] not justiciable 
because it is not clear, due to the ambiguous text of the Risk 
Evaluation Rule, whether the Agency will actually conduct risk 
evaluations in the manner Petitioners fear'').
    EPA plans to consider the appropriate approach for each chemical 
substance risk evaluation on a case-by-case basis, taking into account 
considerations relevant to the specific chemical substance in light of 
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's 
ability to evaluate and manage unreasonable risk from individual 
chemical substances. EPA believes this is a reasonable approach under 
TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of TCE, as further 
explained in this notice, EPA proposes that a whole chemical approach 
is appropriate for TCE in order to protect health and the environment. 
The whole chemical approach is appropriate for TCE because there are 
benchmark exceedances for multiple conditions of use (spanning across 
most aspects of the chemical lifecycle--from manufacturing (including 
import), processing, commercial and industrial use, consumer use, and 
disposal) for health of workers, occupational non-users, consumers, and 
bystanders associated with TCE 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 TCE that the whole chemical presents 
an unreasonable risk.
    As explained later in this document, the revisions to the 
unreasonable risk determination (section 5 of the risk evaluation) 
would be based on the existing risk characterization section of the 
risk evaluation (section 4 of the risk evaluation) and would not 
involve additional technical or scientific analysis. The discussion of 
the issues presented in this Federal Register notice and in the 
accompanying draft revision to the risk determination would supersede 
any conflicting statements in the prior TCE risk evaluation and the 
response to comments document (Ref. 10). With respect to the TCE risk 
evaluation, EPA intends to change the risk determination to a whole 
chemical approach without considering the use of PPE and does not 
intend to amend, nor does a whole chemical approach require amending, 
the underlying scientific analysis of the risk evaluation in the risk 
characterization section of the risk evaluation. EPA views the peer 
reviewed hazard and exposure assessments and associated risk 
characterization as robust and upholding the standards of best 
available science and weight of the scientific evidence per TSCA 
sections 26(h) and (i).
    EPA is announcing the availability of and seeking public comment on 
the draft superseding unreasonable risk determination for TCE, 
including a description of the risks driving the unreasonable risk 
determination under the conditions of use for the chemical substance as 
a whole. For purposes of TSCA section 6(i), EPA is making a draft risk 
determination on TCE as a whole chemical. Under the proposed revised 
approach, the ``whole chemical'' risk determination for TCE would 
supersede the no unreasonable risk determinations for TCE 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 November 2020 TCE risk 
evaluation.

C. What revision does EPA propose about the use of PPE for the TCE 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., 
Occupational Safety and Health Administration (OSHA) requirements for 
protection of workers).
    For the November 2020 TCE risk evaluation, EPA assumed that workers 
used PPE for 21 occupational conditions of use. However, in the 
November 2020 TCE risk evaluation, EPA determined that there is 
unreasonable risk to

[[Page 40524]]

workers for all these COUs even with this assumed PPE use.
    EPA is revising the assumption for TCE 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. 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. 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 November 2020 TCE 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 TCE from a baseline scenario that does not assume compliance 
with OSHA standards, including any applicable exposure limits or 
requirements for use of respiratory protection or other PPE. Making 
unreasonable risk determinations based on the baseline scenario should 
not be viewed as an indication that EPA believes there are no 
occupational safety protections in place at any location, or that there 
is widespread non-compliance with applicable OSHA standards. Rather, it 
reflects EPA's recognition that unreasonable risk may exist for 
subpopulations of workers that may be highly exposed because they are 
not covered by OSHA standards, such as self-employed individuals and 
public sector workers who are not covered by a State Plan, or because 
their employer is out of compliance with OSHA standards, or because 
many of OSHA's chemical-specific permissible exposure limits largely 
adopted in the 1970's are described by OSHA as being ``outdated and 
inadequate for ensuring protection of worker health'' (Ref. 11), or 
because EPA finds unreasonable risk for purposes of TSCA 
notwithstanding OSHA requirements.
    In accordance with this approach, EPA is proposing the draft 
revision to the TCE risk determination without relying on assumptions 
regarding the occupational use of PPE in making the unreasonable risk 
determination under TSCA section 6; rather, information on the use of 
PPE as a means of mitigating risk (including information received from 
industry respondents about occupational safety practices in use) would 
be considered during the risk management phase as appropriate. This 
would represent a change from the approach taken in the 2020 risk 
evaluation for TCE and EPA invites comments on this draft change to the 
TCE risk determination. As a general matter, when undertaking risk 
management actions, EPA intends to strive for consistency with 
applicable OSHA requirements and industry best practices, including 
appropriate application of the hierarchy of controls, when those 
measures would address an identified unreasonable risk, including 
unreasonable risk to potentially exposed or susceptible subpopulations. 
Consistent with TSCA section 9(d), EPA will consult and coordinate TSCA 
activities with OSHA and other relevant Federal agencies for the 
purpose of achieving the maximum applicability of TSCA while avoiding 
the imposition of duplicative requirements. Informed by the mitigation 
scenarios and information gathered during the risk evaluation and risk 
management process, the Agency might propose rules that require risk 
management practices that may be already common practice in many or 
most facilities. Adopting clear, comprehensive regulatory standards 
will foster compliance across all facilities (ensuring a level playing 
field) and assure protections for all affected workers, especially in 
cases where current OSHA standards may not apply or be sufficient to 
address the unreasonable risk.
    Removing the assumption that all workers always and appropriately 
wear PPE in making the whole chemical risk determination for TCE would 
not result in additional conditions of use to the original 52 
conditions of use that drive the unreasonable risk, though EPA would 
identify additional risks for acute non-cancer and cancer effects from 
inhalation and dermal exposures as driving the unreasonable risk within 
many of those conditions of use (where previously those conditions of 
use were identified as presenting unreasonable risk only for chronic 
non-cancer effects and cancer due to assumed use of PPE). 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 TCE?

    TCE is a colorless liquid with a pleasant, sweet odor resembling 
that of chloroform. It is considered a volatile organic compound and 
has a wide range of uses in consumer and commercial products and in 
industry. An estimated 84% of TCE's annual production volume is used as 
an intermediate in the manufacture of the hydrofluorocarbon, HFC-134a, 
an alternative to the refrigerant chlorofluorocarbon, CFC-12. Another 
15% of TCE production volume is used as a degreasing solvent, leaving 
approximately 2% for other uses. The total aggregate production volume

[[Page 40525]]

decreased from 220.5 to 171.9 million pounds between 2012 and 2015.

E. What conclusions did EPA reach about the risks of TCE in the 2020 
TSCA risk evaluation and what conclusions is EPA proposing to reach 
based on the whole chemical approach and not assuming the use of PPE?

    In the 2020 risk evaluation, EPA determined that TCE presents an 
unreasonable risk to health under the following conditions of use:
     Manufacturing: domestic manufacture;
     Manufacturing: import;
     Processing: processing as a reactant/intermediate;
     Processing: incorporation into a formulation, mixture or 
reaction product;
     Processing: incorporation into articles;
     Processing: repackaging;
     Processing: recycling;
     Industrial and commercial use as a solvent for open-top 
batch vapor degreasing;
     Industrial and commercial use as a solvent for closed-loop 
batch vapor degreasing;
     Industrial and commercial use as a solvent for in-line 
conveyorized vapor degreasing;
     Industrial and commercial use as a solvent for in-line web 
cleaner vapor degreasing;
     Industrial and commercial use as a solvent for cold 
cleaning;
     Industrial and commercial use as a solvent for aerosol 
spray degreaser/cleaner and mold release;
     Industrial and commercial use as a lubricant and grease in 
tap and die fluid;
     Industrial and commercial use as a lubricant and grease in 
penetrating lubricant;
     Industrial and commercial use as an adhesive and sealant 
in solvent-based adhesives and sealants; tire repair cement/sealer; 
mirror edge sealant;
     Industrial and commercial use as a functional fluid in 
heat exchange fluid;
     Industrial and commercial use in paints and coatings as a 
diluent in solvent-based paints and coatings;
     Industrial and commercial use in cleaning and furniture 
care products in carpet cleaner and wipe cleaning;
     Industrial and commercial use in laundry and dishwashing 
products in spot remover;
     Industrial and commercial use in arts, crafts, and hobby 
materials in fixatives and finishing spray coatings;
     Industrial and commercial use in corrosion inhibitors and 
anti-scaling agents;
     Industrial and commercial use in processing aids in 
process solvent used in battery manufacture; process solvent used in 
polymer fabric spinning, fluoroelastomer manufacture and Alcantara 
manufacture; extraction solvent used in caprolactam manufacture; 
precipitant used in beta-cyclodextrin manufacture;
     Industrial and commercial use as ink, toner and colorant 
products in toner aid;
     Industrial and commercial use in automotive care products 
in brake parts cleaner;
     Industrial and commercial use in apparel and footwear care 
products in shoe polish;
     Industrial and commercial use in hoof polish; gun 
scrubber; pepper spray; other miscellaneous industrial and commercial 
uses;
     Consumer use as a solvent in brake and parts cleaner;
     Consumer use as a solvent in aerosol electronic degreaser/
cleaner;
     Consumer use as a solvent in liquid electronic degreaser/
cleaner;
     Consumer use as a solvent in aerosol spray degreaser/
cleaner;
     Consumer use as a solvent in liquid degreaser/cleaner;
     Consumer use as a solvent in aerosol gun scrubber;
     Consumer use as a solvent in liquid gun scrubber;
     Consumer use as a solvent in mold release;
     Consumer use as a solvent in aerosol tire cleaner;
     Consumer use as a solvent in liquid tire cleaner;
     Consumer use as a lubricant and grease in tap and die 
fluid;
     Consumer use as a lubricant and grease in penetrating 
lubricant;
     Consumer use as an adhesive and sealant in solvent-based 
adhesives and sealants;
     Consumer use as an adhesive and sealant in mirror edge 
sealant;
     Consumer use as an adhesive and sealant in tire repair 
cement/sealer;
     Consumer use as a cleaning and furniture care product in 
carpet cleaner;
     Consumer use as a cleaning and furniture care product in 
aerosol spot remover;
     Consumer use as a cleaning and furniture case product in 
liquid spot remover;
     Consumer use in arts, crafts, and hobby materials in 
fixative and finishing spray coatings;
     Consumer use in apparel and footwear products in shoe 
polish;
     Consumer use in fabric spray;
     Consumer use in film cleaner;
     Consumer use in hoof polish;
     Consumer use in toner aid; and
     Disposal.
    Under the proposed whole chemical approach to the TCE risk 
determination, the unreasonable risk from TCE would continue to be 
driven by risk from those same conditions of use. In addition, by 
removing the assumption of PPE use in making the whole chemical risk 
determination for TCE, there are no additional conditions of use that 
would drive the draft unreasonable risk determination. The same 52 COUs 
out of the 54 EPA evaluated would continue to drive EPA's unreasonable 
risk determination, though additional risks for acute non-cancer and 
cancer effects from inhalation and dermal exposures would drive the 
unreasonable risk within many of those conditions of use (where 
previously those conditions of use were identified as presenting 
unreasonable risk only for chronic non-cancer effects and cancer due to 
assumed use of PPE). Overall, 52 conditions of use out of the 54 EPA 
evaluated would drive the TCE whole chemical unreasonable risk 
determination.

III. Revision of the November 2020 Risk Evaluation

A. Why is EPA proposing to revise the risk determination for the TCE 
risk evaluation?

    EPA is proposing to revise the risk determination for the TCE risk 
evaluation pursuant to TSCA section 6(b) and consistent with Executive 
Order 13990, (``Protecting Public Health and the Environment and 
Restoring Science to Tackle the Climate Crisis'') and other 
Administration priorities (Refs. 3, 4, and 6). EPA is revising specific 
aspects of the first ten TSCA existing chemical risk evaluations in 
order to ensure that the risk evaluations better align with TSCA's 
objective of protecting health and the environment. For the TCE 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?

    EPA is releasing a draft revision of the risk determination for the 
TCE risk evaluation pursuant to TSCA section 6(b). Under the revised 
determination, EPA preliminarily concludes that TCE, 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

[[Page 40526]]

previous unreasonable risk determinations made for TCE by individual 
conditions of use, supersede the determinations (and withdraw the 
associated order) of no unreasonable risk for the conditions of use 
identified in the TSCA section 6(i)(1) no unreasonable risk order, and 
clarify the lack of reliance on assumed use of PPE as part of the risk 
determination.
    These draft revisions do not alter any of the underlying technical 
or scientific information that informs the risk characterization, and 
as such the hazard, exposure, and risk characterization sections are 
not changed except to the extent that statements about PPE assumptions 
in sections 2.3.1.2.5 (Dermal Exposure Modeling) and section 4.2.2 
(Risk Estimation for Occupational Exposures), Table 4-9 (Inhalation 
Exposure Data Summary and PPE Use Determination), of the TCE risk 
evaluation would be superseded. The discussion of the issues in this 
notice and in the accompanying draft revision to the risk determination 
would supersede any conflicting statements in the prior executive 
summary and sections 2.3.1.2.5 and 4.2.2 from the TCE risk evaluation 
and the response to comments document (Refs. 2 and 10). Additional 
policy changes to other chemical risk evaluations, including any 
consideration of potentially exposed or susceptible subpopulations and/
or inclusion of additional exposure pathways, are not necessarily 
reflected in these draft revisions to the risk determination.

C. Will the draft revised risk determination be peer reviewed?

    The risk determination (section 5 in the November 2020 risk 
evaluation) was not part of the scope of the peer reviews of the TCE 
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 TCE 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 TCE risk evaluation and, after 
considering those public comments, issue the revised final TCE 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 TCE risk evaluation. This final 
revised risk determination would supersede the November 2020 risk 
determinations of no unreasonable risk. Consistent with the statutory 
requirements of TSCA section 6(a), the Agency would then propose risk 
management actions to address the unreasonable risk determined in the 
TCE risk evaluation.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA Draft Revised Unreasonable Risk Determination for TCE, 
Section 5, July 2022.
2. EPA Risk Evaluation for Trichloroethylene. EPA Document #740-R-
18-008. November 2020. https://www.epa.gov/sites/default/files/2020-11/documents/1._risk_evaluation_for_trichloroethylene_tce_casrn_79-01-6.pdf.
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/newsreleases/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, July 20, 2017 (FRL-9964-38).
10. EPA. Summary of External Peer Review and Public Comments and 
Disposition for Trichloroethylene (TCE). November 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0500-0114.
11. 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: July 1, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-14478 Filed 7-6-22; 8:45 am]
BILLING CODE 6560-50-P