for acute and chronic inhalation and dermal exposures, as well as
cancer (liver, kidney, and non-Hodgkin lymphoma) for chronic inhalation
and dermal exposures. EPA also concluded, based on EPA's Guidelines for
Carcinogen Risk Assessment (Ref. 41), that TCE is considered to be
carcinogenic by all routes of exposure and calculated cancer risks from
chronic inhalation and dermal exposures (Ref. 1). Unit IV. summarizes
the health effects and the magnitude of the exposures.
    To make the unreasonable risk determination for TCE, EPA evaluated
exposures to potentially exposed or susceptible subpopulations
including workers, ONUs, consumer users, and bystanders to consumer use
by using reasonably available monitoring and modeling data for
inhalation and dermal exposures. (Ref. 1). EPA conducted a screening-
level analysis to assess potential risks from the air and water
pathways to fenceline communities. A discussion of EPA's analysis and
the expected effects of this rulemaking on fenceline communities is in
Unit VII.A.
    For the 2020 Risk Evaluation for TCE, and as discussed in Unit
II.D.1. and Unit III.A.3., EPA considered PESS. EPA identified the
following groups as PESS: workers and ONUs, including men and women of
reproductive age, adolescents, and biologically susceptible
subpopulations; and consumer users (age 11 and older) and bystanders
(of any age group, including infants, toddlers, children, and elderly),
including biologically susceptible subpopulations. Additionally, older
pregnant women are identified as especially susceptible to cardiac
defects in their developing fetus based on

epidemiological data (Ref. 1). All PESS are included in the
quantitative and qualitative analyses described in the 2020 Risk
Evaluation for TCE and were considered in the determination of
unreasonable risk for TCE (Ref. 1, 2). As discussed in Unit II.D. and
Unit IV.B., the 2020 Risk Evaluation for TCE excluded the air and water
exposure pathways to the general population from the published risk
evaluations and may have caused some risks to be unaccounted for in the
risk evaluation. EPA considers these groups a subset of the general
population and categorizes them as fenceline communities; they may also
be considered PESS. See Unit VII.A. for further discussion on assessing
and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
    EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to address the
unreasonable risk for TCE.
    As required, EPA developed a proposed regulatory action and one or
more primary alternative regulatory actions, which are described in
Units V.A. and V.B., respectively. To identify and select a regulatory
action, EPA considered the two routes of exposure driving the
unreasonable risk, inhalation and dermal, and the exposed populations.
For occupational conditions of use (see Unit III.B.1.f.), EPA
considered how it could directly regulate manufacturing (including
import), processing, distribution in commerce, industrial and
commercial use, or disposal to address the unreasonable risk. EPA does
not have direct authority to regulate consumer use. Therefore, EPA
considered how it could exercise its authority under TSCA to regulate
the manufacturing (including import), processing, and/or distribution
in commerce of TCE at different points in the supply chain to eliminate
exposures or restrict the availability of TCE and TCE-containing
products for consumer use in order to address the unreasonable risk.
    As required by TSCA section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions the effects of TCE on
health, which is described in Unit IV. EPA also factored into its
decisions, to the extent practicable: the effects of TCE on the
environment and the magnitude of exposure to TCE of human beings and
the environment, the benefits of TCE for various uses, and the
reasonably ascertainable economic consequences of the rule. In
evaluating the reasonably ascertainable economic consequences of the
rule, EPA considered: (i) The likely effect of the rule on the national
economy, small business, technological innovation, the environment, and
public health; (ii) The costs and benefits of the proposed regulatory
action and one or more primary alternative regulatory actions
considered; and (iii) The cost effectiveness of the proposed regulatory
action and of the one or more primary alternative regulatory actions
considered. See Unit VII. for further discussion related to TSCA
section 6(c)(2)(A) considerations, including the statement of effects
of the proposed rule with respect to these considerations.
    EPA also considered the regulatory authority under TSCA and other,
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and
other EPA-administered statutes, to examine: (1) Whether there are
opportunities for all or part of risk management action on TCE to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or section 9(b); or (2) Whether TSCA section
6(a) regulation could include alignment of requirements and definitions
in and under existing statutes to minimize confusion to the regulated
entities and the general public.
    In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit VI.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory action in Unit V.).
    To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy of controls adopted by OSHA and NIOSH, with the goal of
identifying risk management control methods that are permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated entities
where appropriate. EPA considered the information presented in the 2020
Risk Evaluation for TCE, as well as additional input from stakeholders
(as described in Unit III.A.), and anticipated compliance strategies
from regulated entities.
    Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory actions described
in Unit V. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit
VI.

IV. Considerations of Health Effects of TCE

    TSCA section 6(a) rules must be promulgated ``in accordance with
subsection (c)(2).'' TSCA section 6(c)(2)(A) requires EPA, in proposing
and promulgating TSCA section 6(a) rules, to ``consider and publish a
statement based on reasonably available information'' with respect to
listed criteria, including the effects and magnitude of exposure to
human health and the environment, the benefits of the chemical
substance for various uses, and the reasonably ascertainable economic
consequences of the rule. Under TSCA section 6(c)(2)(B), EPA must
``factor in, to the extent practicable,'' the considerations under TSCA
section 6(c)(2)(A) when selecting among prohibitions and other
restrictions in TSCA section 6(a) rules. This section discusses the
health effects of TCE. Other TSCA section 6(c)(2) considerations are
discussed further in Unit VII.
    EPA's analysis of the health effects of TCE is in the 2020 Risk
Evaluation (Ref. 1). This unit presents a summary of that information
and an explanation of how EPA considered that information in developing
the proposed and alternative regulatory options.
    TCE has a large database of human health toxicity data. The 2020
Risk Evaluation for TCE identified several endpoints, such as kidney
toxicity, immunotoxicity, or developmental toxicity, and often a single
endpoint was examined by multiple studies. For acute exposures, EPA
identified non-cancer effects (developmental toxicity and
immunosuppression). For chronic exposures, EPA identified non-cancer
effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity,
reproductive toxicity, and developmental toxicity) as well as cancer
(liver, kidney, and non-Hodgkin lymphoma), with kidney cancer
identified as acting through a mutagenic mode of action (Ref. 1). As
discussed in this unit, the 2020 Risk Evaluation for TCE contains
quantitative risk estimates using several points of departure (PODs),
including both the immunotoxicity endpoints as well as the more
sensitive developmental toxicity endpoints, specifically fetal cardiac
defects, and both demonstrate that TCE presents risk.
    Additionally, in developing the 2020 Risk Evaluation for TCE, EPA
analyzed

the reasonably available information to ascertain whether some human
subpopulations may have greater exposure or greater susceptibility than
the general population to the hazard posed by the chemical substance.
Factors affecting susceptibility examined in the reasonably available
studies on TCE include lifestage, sex, genetic polymorphisms, race/
ethnicity, preexisting health status, lifestyle factors, and nutrition
status. Groups of individuals for which one or several of these factors
apply may be considered PESS (Ref. 1).

A. ECEL Value of 0.0011 ppm Based on Developmental Toxicity (Proposed)

    Because TSCA section 6(c)(2)(B) directs EPA to factor in, to the
extent practicable, the health effects of TCE under TSCA section
6(c)(2)(A), TSCA section 6(c) thereby provides EPA with the flexibility
to tailor the regulatory restrictions to account for particular health
effects identified in the underlying risk evaluation. With this
consideration, EPA found that, in some cases, a regulatory option that
could reduce exposures such that they would achieve the benchmark
margin of exposure for the most sensitive non-cancer endpoint
(developmental toxicity) would address any risk for other non-cancer
endpoints. Older pregnant workers and ONUs, who may be especially
susceptible to TCE- induced cardiac defects in their developing fetus,
are classified as a PESS, and the associated POD and risk estimates
were included in the 2020 Risk Evaluation in consideration of PESS
groups. EPA has carefully considered the health effects of TCE on
pregnant workers and ONUs as part of the Agency's development of
proposed requirements that would be applicable to certain occupational
conditions of use of TCE. In order for this rulemaking to appropriately
address risk to all workers and ONUs exposed to TCE through the
occupational conditions of use for which EPA is proposing an ECEL
associated with a WCPP, EPA has factored in consideration of additional
health effects applicable to PESS, including older pregnant workers and
ONUs (the group identified as most susceptible to fetal cardiac
defects) pursuant to TSCA section 6(c)(2), and is proposing an ECEL
value of 0.0011 ppm based on developmental toxicity (Ref. 13).
    In the risk characterization section of the 2020 Risk Evaluation
for TCE, EPA acknowledged that fetal cardiac defects are an acute, non-
cancer endpoint of concern for older pregnant women, while also
acknowledging uncertainty surrounding the use of this endpoint to
inform the determination of whether TCE presents unreasonable risk of
injury to health for all affected human populations. In the 2020 Risk
Evaluation for TCE, EPA presented the Agency's findings with respect to
different endpoints and characterized the immunotoxicity endpoints as
the ``best overall'' non-cancer endpoints for use in the risk
conclusions and risk determination. The endpoints were characterized in
this way precisely because of the quantitative uncertainties
surrounding the use of the fetal cardiac defects endpoint and other
considerations. Further, as noted in Unit II.D.1., EPA has received
numerous comments on EPA's 2020 TSCA Risk Evaluation policy choice
regarding endpoint selection that have raised concerns pertaining to
political interference and scientific integrity, among other issues.
Among the non-cancer adverse health effects, the drivers for EPA's
whole chemical unreasonable risk determination for TCE under TSCA were
identified as immunotoxicity, acute immunosuppression, and chronic
autoimmunity from inhalation and dermal exposures (Ref. 2). EPA
received significant feedback on this aspect of the 2020 Risk
Evaluation for TCE, including focused attention on this issue from the
SACC and public commenters reacting to the draft Risk Evaluation for
TCE (Ref. 42). Moreover, based on the discussion included in the peer
review report of the 2020 Risk Evaluation, EPA also concluded that
reasonable scientists would not disallow the use of the fetal cardiac
defects studies, and that therefore other EPA program reliance on the
fetal cardiac defects endpoint is scientifically valid (e.g., IRIS).
    The 2020 Risk Evaluation for TCE identified the developmental
toxicity endpoint of fetal cardiac defects, which presents a lower POD
than the immunotoxicity endpoints. The magnitude of the unreasonable
risk from exposures to TCE would have been greater had the Agency
relied upon the developmental toxicity endpoint (Ref. 1). Specifically,
EPA identified the risk of fetal cardiac defects most strongly
associated with offspring of older mothers, and therefore included risk
estimates for fetal cardiac defects that account for susceptible
mothers and their offspring in addition to PESS groups with other
susceptibilities (e.g., diabetes, infection status, drug exposure,
stress, and metabolic sensitivity due to increased enzymatic activity
of cytochrome P450 2E1 (CYP2E1) (Ref. 1).
    EPA developed the ECEL for the most sensitive health endpoint
(developmental toxicity) in support of risk management efforts on TCE
under TSCA, to identify that ambient exposures that are kept at or
below the 8-hour ECEL of 0.0011 ppm would protect against risk of
injury to health due to fetal cardiac defects, if those levels can be
achieved. In addition, EPA expects that at the acute non-cancer ECEL of
0.0011 ppm, any potentially exposed person in the workplace would be
protected against other non-cancer effects resulting from occupational
exposures, as well as excess risk of cancer (Ref. 13). EPA expects that
if a facility were able to meet the ECEL (0.0011 ppm) requirement
associated with the WCPP under the proposed regulatory action outlined
in Unit V.A.2., it would protect PESS during the phaseout period before
the full prohibition.

B. ECEL Value of 0.0040 ppm Based on Immunotoxicity (Primary
Alternative)

    In other risk management actions under TSCA section 6, EPA has
proposed basing its worker protection requirements, such as an ECEL, on
a single acute or chronic exposure endpoint that provided the basis for
the unreasonable risk determination (Ref. 40). While EPA is proposing a
different basis for the ECEL for the WCPP for TCE (0.0011 ppm) (to
protect a sensitive PESS), EPA recognizes that among the non-cancer
adverse health effects of TCE, the drivers for EPA's whole chemical
unreasonable risk determination for TCE under TSCA were identified as
immunotoxicity, namely acute immunosuppression and chronic autoimmunity
from inhalation and dermal exposures (Ref. 2). For this reason, the
primary alternative regulatory action provided by EPA includes a WCPP
with a different ECEL (0.0040 ppm), based on the endpoint that drives
the unreasonable risk. As described in more detail in Unit V.B.2.,
reducing exposures to or below the ECEL of 0.0040 ppm would address
that component of the unreasonable risk of injury to health from TCE
that is driven by inhalation exposures in an occupational setting
(Refs. 1, 14). If ambient exposures are kept at or below the 8-hour
ECEL of 0.0040 ppm, EPA expects that workers and ONUs would be
protected against not only the chronic non-cancer effects for
autoimmunity described in this unit, but also effects resulting from
acute non-cancer exposure (immunosuppression) and cancer.
    As described in Unit V.A.2., for the ECEL value of 0.0011 ppm,
proposed as

part of the WCPP, EPA requests comment on the use of TSCA section
6(c)(2) to tailor the risk management actions where necessary to
protect PESS. Also, as described in Unit V.B.2., EPA is requesting
comment on the use of the ECEL value of 0.0040 ppm in the WCPP in the
alternative regulatory action. Specifically, EPA is requesting comment
on the selection of the fetal cardiac defects endpoint for the ECEL of
0.0011 ppm in the proposed regulatory action, rather than the
immunotoxicity endpoint on which the unreasonable risk determination is
based, which would result in an ECEL of 0.0040 ppm. EPA is also
requesting comment on additional ways to protect workers and ONUs who
are or may become pregnant.

V. Proposed and Primary Alternative Regulatory Actions

    This unit describes the proposed regulatory action by EPA so that
TCE will no longer present an unreasonable risk of injury to health. In
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost effectiveness of the proposed
regulatory action and one or more primary alternative regulatory
actions. In the case of TCE, the proposed regulatory action is
described in Unit V.A. and the primary alternative regulatory action
considered is described in Unit V.B. An overview of the proposed
regulatory action and primary alternative regulatory action for each
condition of use is in Unit V.C. The rationale for the proposed and
primary alternative regulatory actions and associated compliance
timeframes are discussed in this unit and in more detail in Unit VI.A.

A. Proposed Regulatory Action

    EPA is proposing under TSCA section 6(a) to: Prohibit all
manufacture (including import), processing, distribution in commerce,
and industrial and commercial use of TCE for all uses (including all
consumer uses), with longer timeframes and workplace controls for
certain processing and industrial and commercial uses (including
proposed phaseouts and TSCA section 6(g) exemptions); prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works with a 50-year TSCA section 6(g)
exemption for cleanup projects; and establish recordkeeping and
downstream notifications requirements. Prohibitions on manufacturing
(including import) and processing, including staggered implementation
timeframes to account for the supply chain, are outlined in Unit
V.A.1.a.; prohibitions on industrial and commercial uses and
distribution in commerce are outlined in Unit V.A.1.b.; and
prohibitions related to consumer uses are outlined in Unit V.A.1.c.
    EPA is proposing longer compliance timeframes (with workplace
controls) for prohibitions on certain conditions of use. The timeframe
for a prohibition or phaseout under TSCA section 6(d) must begin as
soon as practicable, but not later than 5 years, with the full
implementation of the prohibition or phase-out requirements occurring
as soon as practicable and providing for a reasonable transition
period. For a TSCA section 6(g) exemption for a specific condition of
use, EPA must establish a time limit as reasonable on a case-by-case
basis as long as the exemption meets the criteria under TSCA section
6(g)(1). First, EPA is proposing to prohibit the manufacturing
(including import) and processing of TCE as an intermediate for the
manufacture of HFC-134a through an 8.5-year phaseout, as outlined in
Unit V.A.1.d. Second, EPA is proposing a 10-year phaseout for the
industrial and commercial use of TCE as a solvent for closed-loop batch
vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production for Federal agencies and their contractors,
conditioned on a final pre-launch test within 5 years of rocket booster
nozzles that have been produced without using TCE, as outlined in Unit
V.A.1.e. Third, EPA is proposing a time-limited exemption for 10 years
under a TSCA section 6(g) exemption related to prohibitions on the
industrial and commercial use of TCE as a processing aid for battery
separator manufacturing, as outlined in Unit V.A.3.b.i. Fourth, EPA is
proposing a time-limited exemption for 10 years under a TSCA section
6(g) exemption related to prohibitions on industrial uses of TCE for
DoD vessel requirements for potting, bonding and sealing compounds, and
bonding and cleaning requirements for naval combat systems, radars,
sensors, equipment, and fabrication and prototyping processes, as
outlined in Unit V.A.3.b.ii. Fifth, EPA is proposing a time-limited
exemption for 50 years under a TSCA section 6(g) exemption related to
prohibitions on the industrial and commercial use of TCE in laboratory
use for essential laboratory activities and some research and
development activities, as outlined in Unit V.A.3.b.iii. Sixth, EPA is
proposing a time-limited exemption for 7 years under a TSCA section
6(g) exemption related to prohibitions on the industrial and commercial
use of TCE as a solvent in closed loop vapor degreasing necessary for
human-rated rocket engine cleaning by NASA and its contractors.
Seventh, EPA is proposing a time-limited exemption for 10 years under a
TSCA section 6(g) exemption for emergency industrial and commercial use
of TCE for specific conditions of use which are critical or essential
in furtherance of NASA's mission and for which no technically and
economically safer alternative is available. Where conditions of use
would be prohibited under timeframes longer than one year, EPA's
proposal aims to align with elements of existing OSHA regulations and
industrial hygiene best practices to the extent possible by
implementing a Workplace Chemical Protection Program (WCPP). The WCPP
includes requirements for an inhalation exposure limit and glove
requirements to limit exposure to TCE until the prohibitions take
effect, as outlined in Unit V.A.2. Lastly, EPA is proposing to prohibit
certain disposal of TCE (specifically, the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works), as outlined in Unit V.A.1.f., with a time limited 50-
year exemption for cleanup projects as outlined in Unit V.A.3.b.iv; and
establish recordkeeping and downstream notification requirements, as
outlined in Unit V.A.4. EPA requests comment on the applicability to
the private sector of proposed regulatory actions pertaining
specifically to Federal agencies, namely industrial uses for DoD vessel
requirements and closed-loop batch vapor degreasing for rayon fabric
scouring for rocket booster nozzle production. EPA requests comment on
the extent to which the private sector would be affected by a
prohibition on these uses.
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce,
Use, and Disposal
a. Prohibitions on Manufacturing (Including Import) and Processing of
TCE
    EPA is proposing to prohibit the manufacturing (including import)
and processing of TCE based on the unreasonable risk to workers and
ONUs driven by these conditions of use (Ref. 2). As the manufacture and
processing of TCE presents and unreasonable risk to health in the
United States, the manufacture and processing of TCE for export would
also be prohibited in accordance with TSCA section 12(a)(2).
    As discussed in Units III.B.3. and VI.A., based on the Agency's
consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty

relative to the feasibility of exposure reduction to sufficiently
address the unreasonable risk across the broad range of occupational
environments and activities that occur in manufacturing (including
import) and processing conditions of use, and the irreversible health
effects associated with TCE exposures, EPA has determined that
prohibition is the best way to address the unreasonable risk.
    EPA is proposing that the prohibitions on manufacturing (including
import) and processing of TCE would follow a staggered schedule, due to
supply chain considerations. EPA proposes that the compliance dates for
the proposed prohibitions described in this unit, such that the
requirements would come into effect in 90 days (3 months) for
manufacturers and in 180 days (6 months) for processors, with different
timeframes related to specific conditions of use. Specifically, for
processing TCE as a reactant/intermediate, EPA is proposing that the
compliance dates for the proposed prohibitions described in this unit
would come into effect in 1.5 years for manufacturers and 2 years for
processors. There are additional exceptions from the prohibition for
the manufacturing and processing associated with certain processing and
industrial and commercial uses, including those described later in this
unit (for which EPA is proposing longer compliance timeframes,
including phaseouts (see Units V.A.1.b., d., and e.) or time-limited
exemptions under TSCA section 6(g) (see Unit V.A.3.b.)). The rationale
for longer timeframes for certain conditions of use is described in
Unit VI.A.1.
b. Prohibitions on Industrial and Commercial Use and Distribution in
Commerce of TCE
    EPA is proposing to prohibit the industrial and commercial use of
TCE, based on the unreasonable risk to workers and ONUs driven by these
conditions of use (Ref. 2). As discussed in Units III.B.3. and VI.A.,
based on consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty relative to the feasibility of exposure reduction to
sufficiently address the unreasonable risk across the broad range of
work environments and activities represented by industrial and
commercial uses of TCE, and the irreversible health effects associated
with TCE exposures, EPA has determined that prohibition is the best way
to address the unreasonable risk. However, in consideration of the
challenges several sectors may encounter in adopting alternatives to
TCE, EPA is proposing longer compliance timeframes for certain uses
under this prohibition.
    EPA is proposing compliance dates for the proposed prohibitions
that would come into effect for most industrial and commercial users
270 days after the publication date of the final rule. However, EPA is
proposing longer compliance timeframes under this prohibition for some
industrial and commercial uses and for the associated manufacturing
(including import), processing, and distribution in commerce.
Specifically, for two batch vapor degreasing conditions of use (open-
top and closed-loop), EPA is proposing that the compliance dates for
the proposed prohibitions described in this unit would come into effect
in 180 days for manufacturers, in 270 days (9 months) for processors,
specifically for processing into a formulation and for recycling, and
in 1 year for the industrial and commercial uses of TCE in open-top and
closed-loop batch vapor degreasers (see Unit III.B.1.c.i. and ii. for
descriptions of these conditions of use and Unit VI.A.1. for a
rationale for the slightly longer timeframe). For a sub-set of the
closed-loop batch vapor degreasing condition of use (industrial and
commercial use of TCE as a solvent for closed-loop batch vapor
degreasing for rayon fabric scouring for end use in rocket booster
nozzle production for Federal agencies and their contractors) EPA is
proposing that the compliance dates for the proposed prohibitions
described in this unit would come into effect in five or 10 years for
manufacturers, processors, distributors, and industrial and commercial
users, depending on whether the conditions of the phaseout are met (see
Unit V.A.1.e. for a description of the conditions of this proposed
exemption, and Unit VI.A.1. for the rationale for this timeframe).
Also, EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit would come into effect for
commercial use of TCE as a processing aid in 1.5 years for
manufacturers, in 2 years for processors, and in 2 years for industrial
and commercial use of TCE in: processing aid in process solvent used in
battery manufacture; process solvent used in polymer fiber spinning,
fluoroelastomer manufacture and Alcantara manufacture; extraction
solvent used in caprolactam manufacture; and precipitant used in beta-
cyclodextrin manufacture (see Unit III.B.1.c.xvi. for a description of
this condition of use and Unit V.A.1. for a rationale for the different
timeframe).
    To aid with implementation of the compliance dates for the proposed
prohibitions on manufacturing, processing, and industrial and
commercial use of TCE, and ensure that those prohibitions effectively
address the unreasonable risk identified, EPA is also proposing
prohibitions on distribution in commerce of TCE. Generally, for most
conditions of use EPA is proposing that the compliance date for the
proposed prohibition on distributors in commerce of TCE would come into
effect 180 days (6 months) following publication of the final rule. In
instances where EPA is proposing a prohibition on manufacturing and
processing TCE for a particular industrial and commercial use that is
later than 180 days after publication of the final rule, the compliance
date for the proposed prohibition on distribution in commerce would be
the same as the compliance date of the proposed prohibition on
manufacturing and processing TCE.
    As noted in Unit III.B.1.f., this proposal does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA section 3(2)(B)(ii) through (vi). EPA requests comment on the
impacts, if any, that a prohibition on the processing of TCE into a
formulation, mixture or reaction product in other chemical products and
preparations, or other aspects of this proposal, may have on the
production and availability of any pesticide or other substance
excluded from the TSCA definition of ``chemical substance.'' EPA also
requests comment on whether it should consider a de minimis level of
TCE in formulations to account for impurities (e.g., 0.1% or 0.5%) when
finalizing the prohibitions described in this unit, and, if so,
information on and rationale for any level that should be considered de
minimis.
    When proposing the compliance dates described in this unit as
required under TSCA section 6(d), EPA considered irreversible health
effects associated with TCE exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
However, EPA requests comment on whether additional time is needed, for
example, for products to clear the channels of trade, or for
implementing the use of substitutes; comments should include
documentation such as the specific use of the chemical throughout the
supply chain; concrete steps taken to identify, test, and qualify
substitutes for those uses (including details on the substitutes tested
and the specific

certifications that would require updating); and estimates of the time
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply. EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
c. Prohibitions of Manufacturing, Processing, and Distribution in
Commerce of TCE for Consumer Use
    The consumer uses evaluated in the 2020 Risk Evaluation for TCE
constitute all known, intended, and reasonably foreseen consumer uses
of TCE. As described in this unit, EPA is proposing to prohibit all
manufacturing (including import) and processing of TCE to address the
unreasonable risk to workers and ONUs driven by those conditions of use
(Ref. 2). EPA does not believe any delays are necessary for
prohibitions on manufacture (including import), processing, or
distribution in commerce of TCE for consumer use. EPA notes that not
only did all but one of the 24 consumer uses of TCE evaluated in the
2020 Risk Evaluation for TCE support the unreasonable risk
determination for TCE (Refs. 1, 2), but also the manufacture (including
import) and processing of TCE for consumer uses generally supports
EPA's unreasonable risk determination for workers and ONUs, as further
discussed in Unit V.A. For these reasons, and based on considerations
of the severity of the hazards of TCE, EPA is proposing to prohibit the
manufacturing (including import), processing, and distribution in
commerce of TCE for all uses, which includes all consumer uses.
    EPA is proposing that the compliance dates for the proposed
prohibitions described in this unit relevant to consumer uses would
come into effect for manufacturers 90 days (3 months) and for
processors 180 days (6 months) after the publication date of the final
rule in the Federal Register. EPA is also proposing prohibitions on
distribution in commerce of TCE for consumer uses to aid with effective
implementation of the prohibitions on manufacturing and processing, and
to address the unreasonable risk to consumers and bystanders. EPA
proposes that the compliance dates for the proposed prohibition on
distribution in commerce of TCE for consumer use would come into effect
180 days (6 months) after the publication date of the rule in the
Federal Register. EPA considered the risk of irreversible health
effects associated with TCE exposure when proposing these compliance
dates. EPA has no reasonably available information indicating these
proposed compliance dates are not practicable for the activities that
would be prohibited or that additional time is needed for products to
clear the channels of trade. However, EPA requests comment on whether
additional time is needed, for example, for products to clear the
channels of trade, or for implementing the use of substitutes; comments
should include the considerations described in Unit V.A.1.b. EPA may
finalize significantly shorter or longer compliance timeframes based on
consideration of public comments.
    EPA also requests comment on whether it should consider a de
minimis level of TCE in formulations to account for impurities (e.g.,
0.1% or 0.5%) when finalizing the prohibitions described in this unit,
and, if so, information on and rationale for any level that should be
considered de minimis.
d. Phaseout of TCE for Processing as an Intermediate for the
Manufacture of HFC-134a.
    As described in this unit, EPA is proposing a longer phaseout
timeframe for the manufacturing (including import) and processing of
TCE as an intermediate for the manufacture of HFC-134a (1,1,1,2-
Tetrafluroethane; CAS Number 811-97-2). EPA is proposing an 8.5-year
phaseout subject to the requirements discussed in this unit. All other
processing of TCE as a reactant/intermediate would be subject to the
proposed prohibitions described in Unit V.A.1.b. EPA is proposing to
require a phaseout for processing of TCE as an intermediate for the
manufacture of HFC-134a, which EPA expects would begin at the final
rule's effective date and end 8.5 years after the publication of the
final rule. Associated with this phaseout, EPA would require the
establishment of the TCE WCPP, outlined in Unit V.A.2., within 6 months
after publication of the final rule, as workplace protections during
the period of the phaseout. To set the phaseout volumes, EPA would
require any facility processing TCE as an intermediate to manufacture
HFC-134a in the United States to establish a baseline of the annual
quantity of TCE processed by the facility as a feedstock to manufacture
HFC-134a. EPA is proposing to require that within 6 months after the
publication of the final rule the manufacturer could use the average of
any 12 consecutive months in the 36 months preceding the publication of
the final rule to calculate their baseline, based on records that
demonstrate how the baseline annual volume was calculated. Following
the establishment of a baseline volume, the regulated entity would then
be required to implement a 4-step phaseout process; specifically, the
phaseout would be a 25 percent reduction from the baseline volume every
2 years as follows: (1) 2.5 years after the publication of the final
rule each manufacturer of HFC-134a who processes TCE as an intermediate
would not be permitted to process TCE as an intermediate at an annual
volume greater than 75 percent of the baseline; (2) 4.5 years after the
publication of the final rule each manufacturer of HFC-134a who
processes TCE as an intermediate would not be permitted to process TCE
as an intermediate at an annual volume greater than 50 percent of the
baseline; (3) 6.5 years after the publication of the final rule each
manufacturer of HFC-134a who processes TCE as an intermediate would not
be permitted to process TCE as an intermediate at an annual volume
greater than 25 percent of the baseline; and (4) 8.5 years after the
publication of the final rule each manufacturer of HFC-134a would be
prohibited from processing TCE as an intermediate.
    EPA notes that the prohibition for manufacture (including
importing), processing, and distribution in commerce of TCE for this
condition of use would occur after 8.5 years to account for
availability of TCE through the supply chain during the period of the
phaseout of processing of TCE as an intermediate for the manufacture of
HFC-134a. This timeframe would be longer than the prohibitions on
manufacturing and processing TCE described in Unit V.A.1.a.
    EPA is also proposing to require regulated entities to keep records
of the annual quantity of TCE purchased and processed from the year
2023 until the termination of all processing of TCE as an intermediate.
EPA requests comment on whether additional recordkeeping requirements
are warranted or additional time would be needed, for example, to begin
the phaseout of processing TCE as an intermediate for the manufacture
of HFC-134a.
    EPA notes, per TSCA section 6(c)(2)(C), that although the use of
TCE to produce HFC-134a would be prohibited eventually due to
unreasonable risk, the use of PCE to produce HFC-134a is proposed to
continue in perpetuity under a WCPP (88 FR 39652, July 16, 2023). As
such, the refrigerant would remain available while protecting workers.

e. Phaseout of TCE in industrial and Commercial Use as a Solvent for
Closed-Loop Batch Vapor Degreasing for Rayon Fabric Scouring for Rocket
Booster Nozzle Production
    EPA is proposing a longer phaseout timeframe for industrial and
commercial use as a solvent for closed-loop batch vapor degreasing for
rayon fabric scouring for end use in rocket booster nozzle production
by Federal agencies and their contractors. This is the industrial and
commercial use of TCE in a closed-loop batch vapor degreaser to clean,
or `scour,' rayon fabric to remove sizing (i.e., protective filler or
glaze on textiles), oils, and other contaminants from the rayon fabric
that is used to line the inside of rocket booster nozzles; the
degreasing is essential in preparing the rayon fabric before a
carbonization process ahead of being used in the rocket booster
nozzles. If contaminants are not removed properly from the rayon, the
result could include nozzle failure (Ref. 43). More information on this
use and the rationale for the phaseout are in Unit VI.A.1. For this
sub-set of the vapor degreasing condition of use, when conducted by
Federal agencies and their contractors, EPA is proposing a 10-year
phaseout subject to the requirements discussed in this unit. (All other
industrial and commercial use of TCE as a solvent for vapor degreasing,
including use of TCE in closed-loop batch vapor degreasing of other
parts or materials, would be subject to the proposed prohibitions
described in Unit V.A.1.b.). For the phaseout, EPA is proposing that
within 5 years of the publication date of the final rule the Federal
agency that is the end user of the rayon fabric for rocket booster
nozzle production (e.g., the U.S. Department of Defense (DOD) or the
NASA) would need to conduct a final pre-launch test of rocket boosters
without using TCE; this test is further discussed in Unit VI.A.1.a. By
10 years from the publication date of the final rule, the phaseout
would be complete and industrial and commercial use of TCE as a solvent
for closed-loop batch vapor degreasing, including for rayon fabric
scouring for end use in rocket booster nozzle production by Federal
agencies and their contractors, would be prohibited. As part of this
phaseout, EPA would require a TCE WCPP, described in Unit V.A.2.,
within 6 months after publication of the final rule, as workplace
protections during the period of the phaseout until the full
prohibition takes effect. Additionally, this phaseout would include
recordkeeping requirements beginning 6 months after publication of the
final rule related to the rayon fabric scouring for end use in rocket
booster nozzle production. The entity must have records indicating that
their closed-loop batch vapor degreasing with TCE is for rayon fabric
scouring for end use in rocket booster nozzle production for a Federal
agency or a contractor. Beginning 5 years after the publication of the
final rule, to continue to use TCE for closed-loop batch vapor
degreasing for this specific use, the user must have records from a
Federal agency indicating that a final pre-launch test for the rayon
fabric scouring has been conducted with an alternative chemical or
process.
f. Prohibition of Disposal of TCE to Industrial Pre-Treatment,
Industrial Treatment, or Publicly Owned Treatment Works
    Due to the unreasonable risk to workers exposed to TCE while
performing industrial wastewater pre-treatment and treatment, EPA is
proposing to prohibit this mode of disposal of TCE (i.e., generated
wastewater that contains TCE that is collected on site or transported
to a third party site, and includes the mixing of TCE with wastewater
and the discharge of TCE-contaminated wastewater) (description of
disposal for the purposes of this rulemaking is in Unit III.B.2.d.).
TSCA section 6(a) provides EPA the authority to prohibit or otherwise
regulate any manner or method of disposal of a chemical substance by
its manufacturer, processor, or any other person who uses or disposes
of it for commercial purposes. EPA is proposing to prohibit the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works. Facilities generating solid waste with
TCE concentrations above the RCRA regulatory level of 0.5 mg/L using
the Toxicity Characteristic Leaching Procedure (see 40 CFR 261.24)
would need to manage TCE separately from wastewater and dispose of TCE
through a different disposal mechanism, due to the prohibition in RCRA
against using dilution as a substitute for appropriate treatment (see
40 CFR 268.3), while following the appropriate RCRA requirements when
handling waste containing TCE. Dilution of hazardous waste (including
by mixing it with wastewater) as a substitution for adequate treatment
is prohibited under RCRA (see 40 CFR 268.3).
    EPA is proposing that the compliance date for the proposed
prohibition described in this unit would be 270 days (9 months) after
the publication date of the final rule for manufacturers, processors,
distributors, and industrial and commercial users disposing of TCE to
wastewater. EPA has no information indicating that the proposed
compliance dates would not be practicable for purposes of finding an
alternative disposal method, or that additional time would be needed,
for example, for facilities to transition to an alternative disposal
method. EPA's understanding is that only 1 percent of TCE is disposed
of as wastewater. However, EPA requests comment on whether the 270-day
proposed compliance date is practicable, whether additional time is
needed, for example, for a regulated entity to implement a change to
their disposal processes or to transition to alternative disposal
methods, including what those alternative disposal methods would be,
and their cost and feasibility. EPA is also proposing, as described in
Unit V.A.3., a time-limited exemption for 50 years under TSCA section
6(g) for disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purpose of cleanup
projects of TCE-contaminated groundwater and other wastewater.
2. WCPP for Certain Conditions of Use
a. Overview
    As described in Unit III.B.3., EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. The TSCA section 6(a) requirements provide EPA the authority
to limit or restrict a number of activities, alone or in combination,
including the manufacture, processing, distribution in commerce,
commercial use, and disposal of the chemical substance. Given this
authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational conditions
of use (e.g., manufacturing, processing, industrial and commercial
use). However, for the reasons described in Unit VI., including the
challenges of reliably reducing exposure below the ECEL and being able
to monitor at the appropriate action level, EPA's proposed requirement
for the TCE WCPP is that owners or operators ensure that no person is
exposed to TCE in excess of the ECEL as an 8-hr TWA to the extent
possible (supported by documentation further described in Unit
V.A.2.d.i.) rather than (as has been proposed in other rules under TSCA
section 6) a requirement that exposures do not exceed the ECEL. Due to
these

challenges, as well as the severity of the hazard from TCE, EPA notes
that long-term implementation of the WCPP would not be a feasible means
of addressing TCE unreasonable risk and thus EPA believes that
prohibition of the COUs would ultimately be necessary to address the
unreasonable risk. Furthermore, when selecting among proposed
prohibitions and other restrictions that would apply to those
occupational conditions of use, EPA has also factored in considerations
relating to health effects on PESS, including on older pregnant workers
and ONUs (the group identified as most susceptible to fetal cardiac
defects), further discussed in Units V.A.1. and VI.A. For the time
period before which a prohibition would become effective, for several
conditions of use, EPA is proposing a TCE WCPP to address to the extent
possible the unreasonable risk. The WCPP would include a TCE ECEL of
0.0011 ppm, the associated implementation requirements, and may include
other components, such as dermal protection, as described in this unit.
    EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, ONUs, employees, independent
contractors, employers, and all other persons in the work area who may
be exposed to TCE under the conditions of use for which a WCPP would
apply. EPA's intention is to require a comprehensive WCPP that would
put additional protections in place to reduce the unreasonable risk
from TCE to potentially exposed persons directly handling the chemical
or in the area where the chemical is being used, until the prohibition
compliance date.
    Similarly, the risk evaluation for TCE did not distinguish between
employers, contractors, or other legal entities or businesses that
manufacture, process, distribute in commerce, use, or dispose of TCE.
EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use is occurring and TCE is present. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace.
    An ECEL is a risk-based inhalation exposure threshold. The ECEL
would be accompanied by monitoring, training, recordkeeping, and other
requirements so that exposures to TCE are reduced to the extent
possible (as supported by documentation further described in Unit
V.A.2.d.i.). With an ECEL, the WCPP provides the least uncertainty
regarding the protection afforded to workers, requires regulated
entities to consider more protective controls in the hierarchy, and
lessens the burden on workers. Under this proposal, regulated entities
would have some flexibility in the manner in which they implement
modifications, within certain parameters outlined in this unit, or
otherwise aim to prevent exceedances of the ECEL at their facilities.
Therefore, EPA generally refers to the ECEL and ancillary requirements
as a non-prescriptive approach. This unit includes a summary of the
proposed TCE WCPP, including a description of the proposed ECEL of
0.0011 ppm; proposed implementation requirements and an EPA ECEL action
level; proposed monitoring requirements; a description of potential
exposure controls, which consider the hierarchy of controls;
information that may be used to inform respirator selection; proposed
glove requirements; and additional requirements proposed for
recordkeeping, and worker training, participation, and notification.
This unit also describes proposed compliance timeframes for these
proposed requirements.
    EPA does not believe that long-term implementation of the WCPP
would be a feasible means of addressing unreasonable risk indefinitely;
thus prohibition of the use of TCE for affected COUs is ultimately
necessary to address the risk so that it is no longer unreasonable, due
to the severity of the hazard, the magnitude of the exposures, and the
challenges of consistently reducing exposures below the low TCE ECEL in
a way that is consistent with the hierarchy of controls, further
described in Unit VI.A.1. However, for the conditions of use which
would continue for longer than a year, as well as during the proposed
TSCA section 6(g) time-limited exemption, EPA is proposing the WCPP to
reduce to the extent possible the unreasonable risk from TCE during the
time period before compliance dates for the proposed prohibition would
come into effect. EPA is not proposing the WCPP for uses that would be
prohibited within 1 year from the effective date of the final rule.
Based on reasonably available information, EPA expects that the ECEL is
likely to be exceeded and that compliance with the WCPP would require
large investments into PPE and engineering controls at facilities. For
this reason, EPA's proposal aims to encourage facilities engaged in
uses that would be prohibited within a year from finalization to focus
their resources on the transition to alternatives to TCE. EPA is
requesting comment on how entities could demonstrate that they are
reducing exposures to the extent possible (including considerations for
technological feasibility) and is also requesting comment on whether
EPA's requirement should be that entities ensure that exposures are
reduced below the ECEL, rather than to the extent possible or lowest
achievable level described further in Unit V.A.2.d.i. Should regulated
entities be able to consistently demonstrate compliance with an ECEL
through effective controls, EPA requests comments regarding replacing
the proposed prohibitions with compliance with the WCPP.
b. Existing Chemical Exposure Limit (ECEL)
i. ECEL and ECEL Action Level
    To reduce exposures in the workplace and eliminate the unreasonable
risk of injury to health resulting from inhalation exposures to TCE
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for TCE, EPA is proposing an ECEL of 0.0011 parts per
million (ppm) (0.0059 mg/m\3\) for inhalation exposures to TCE as an 8-
hour TWA. As described in Unit IV.A., this ECEL is based on
developmental toxicity, the most sensitive acute and chronic non-cancer
health endpoint, specifically calculated based on the occupational
acute, non-cancer human equivalent concentration (HEC) for fetal
cardiac defects (Ref. 13). EPA is proposing to establish requirements
for an ECEL as part of the WCPP until the prohibition compliance date
for certain conditions of use that would be permitted to continue for
longer than a year after the effective date of the final rule,
including the conditions of use described in Unit V.A.1.a., as well as
the conditions of use that would be subject to the phaseout described
in Unit V.A.1.d. and the TSCA section 6(g) exemptions described in Unit
V.A.3.
    Each owner or operator of a workplace where these conditions of use
occur would be responsible for compliance with the ECEL and the
associated requirements. EPA's description for how the requirements
related to an ECEL would reduce the unreasonable risk resulting from
inhalation exposures and the rationale for this regulatory approach is
outlined in Units III.B.3. and V.A.
    In order for this rulemaking to appropriately reduce risk to all
potentially exposed persons that may be exposed to TCE through the
occupational conditions of use for which EPA is proposing compliance
with the WCPP as a protection measure,

EPA has factored in consideration of additional health effects
applicable to PESS pursuant to TSCA section 6(c)(2), outlined in Unit
VI.A. EPA developed the ECEL for the most sensitive health endpoint
(fetal cardiac defects) in support of risk management efforts on TCE
under TSCA, to identify at what level ambient exposures would protect
against unreasonable risk of injury to health due to fetal cardiac
defects. The level identified is an 8-hour ECEL of 0.0011 ppm, which,
when possible to achieve, is the concentration at which an adult human
would be unlikely to experience the specified adverse effects if
exposed during a working lifetime, including susceptible
subpopulations. In addition, at the acute non-cancer ECEL of 0.0011
ppm, any potentially exposed person in the workplace would be protected
against other non-cancer effects resulting from occupational exposures,
as well as excess risk of cancer (Ref. 13). However, as noted in Unit
IV., EPA does not believe that long-term implementation of the WCPP
with this low ECEL would be a feasible means of addressing unreasonable
risk indefinitely, and EPA is uncertain if the ECEL and associated
action level can be met reliably as discussed further in Unit VI.A.1.
    EPA invites comment on the existing practices (e.g., engineering
controls, administrative controls, PPE) involving TCE for the
conditions of use listed in Unit V.A.1.a., Unit V.A.1.d., and Unit
V.A.3., whether activities may take place in closed systems, and the
degree to which users of TCE in these sectors could successfully
implement the WCPP, including an ECEL of 0.0011 ppm for TCE, dermal
protection, and ancillary requirements described in Unit IV.A. EPA
acknowledges that reducing and accurately detecting exposures from the
current OSHA PEL of 100 ppm to the proposed TSCA ECEL of 0.0011 ppm
would be very difficult. EPA also invites comment on the potential to
develop future technologies (e.g., engineering controls, administrative
controls, PPE) involving TCE for the conditions of use listed in Unit
V.A.1.a., Unit V.A.1.d., and Unit V.A.3., that would facilitate
successful implementation of the WCPP, including an ECEL of 0.0011 ppm
for TCE, dermal protection, and ancillary requirements described in
Unit IV.A. EPA is also requesting comment on the feasibility of
controlling worker exposures to TCE at or below the proposed ECEL, and
the accuracy of measurements at this level. This is important for
determining whether there are realistic and effective exposure controls
that can be used by industry for effectively controlling exposures to
levels at or below the ECEL. To the extent time is needed to ensure
methods are available to accurately measure TCE at or below the ECEL,
EPA is requesting comment on whether a phased approach to an ECEL is
desirable; that is, an approach that would establish a timeframe for
meeting the ECEL as well as a shorter timeframe for meeting a
concentration level higher than the ECEL (but lower than the PEL) that
is currently considered achievable. EPA welcomes data or information to
demonstrate that meeting the proposed ECEL over a sustained period of
time would be feasible and measurable.
    EPA is also proposing to establish an ECEL action level of 0.00055
ppm as an 8-hour TWA for TCE. Air concentrations at or above the action
level would trigger more frequent periodic monitoring of exposures to
TCE, as described in this unit. EPA is proposing to adopt the action
level approach in implementing the TSCA ECEL, similar to the action
level approach used by OSHA in the implementation of OSHA standards,
although the values differ due to differing statutory authorities. As
explained by OSHA, due to the variable nature of employee exposures,
compliance with an action level provides employers with greater
assurance that their employees will not be exposed to concentrations
above the PELs (Ref. 44). EPA agrees with this reasoning and, like
OSHA, expects the inclusion of an ECEL action level will stimulate
innovation within industry to reduce exposures to levels below the
action level. Therefore, EPA has identified a need for an action level
for TCE and is proposing a level that would be half the 8-hour ECEL,
which is in alignment with the precedented approach established under
most OSHA standards. EPA is soliciting comment regarding an ECEL action
level that is half the ECEL and any associated provisions related to
the ECEL action level when the ECEL is significantly lower than the
OSHA PEL. EPA is also soliciting comment on whether the ECEL action
level should be aligned with OSHA PEL action levels (typically set at
half the limit) due to the fact that PEL accounts for technological
feasibility and the action level is not necessarily designed to be
health protective. Since exposure below the ECEL would be health
protective, EPA seeks comment on whether the action level should be set
at a different value closer to the ECEL that would trigger increased
monitoring to ensure that the ECEL is not exceeded, and whether
technological feasibility should be considered in setting the action
level.
    In summary, EPA is proposing that each owner or operator of a
workplace subject to compliance with the TCE WCPP must ensure that no
person is exposed to an airborne concentration of TCE in excess of
0.0011 ppm (0.0059 mg/m3) as an 8-hour TWA (ECEL), with an action level
identified as 0.00055 ppm (0.0029 mg/m3) (ECEL action level) to the
extent possible, as supported by documentation further described in
Unit V.A.2.d.i.). For conditions of use for which the requirements to
comply with the WCPP are being proposed, EPA expects that measurement
of extremely low-ppm levels of TCE may present challenges to the
regulated community. During the development of the TCE ECEL, EPA
conducted a search to identify relevant NIOSH, OSHA, and EPA analytical
methods that may be used to monitor for the presence of TCE in indoor
air. While EPA identified analytical methods that may be used, based on
information from stakeholders, EPA also recognizes that it may be
difficult to operationalize routine use of these methods for detection
at the low levels needed for the TCE ECEL and ECEL action level.
Specifically, these methods may be challenging to use for personal
breathing zone monitoring to detect lower air concentration levels at
the ECEL and ECEL action level based on the developmental toxicity
endpoint for fetal cardiac defects (Ref. 13). However, EPA acknowledges
that in recent years commercial passive air sampling devices have
improved and may be available for use for personal air sampling at
extremely low-ppm levels of TCE (Ref. 45). EPA is requesting comment on
personal air sampling devices that are capable of detecting indoor air
TCE concentrations at or below the ECEL action level of 0.00055 ppm
(0.0029 mg/m3) with the requisite precision and accuracy.
    EPA acknowledges that the challenge of suitable personal breathing
zone monitoring methods to detect TCE air concentration levels at the
ECEL of 0.0011 ppm and ECEL action level of 0.00055 ppm could cause
difficulty in determining whether a workplace is in compliance with the
ECEL. EPA is therefore requesting comment on whether to require
compliance with an interim exposure level based on the limit of
detection of established analytical methods. This interim level, unlike
the ECEL, would not necessarily eliminate unreasonable risk, but rather
reduce risk to an extent that corresponds to the air concentration that
current analytical methods can reliably measure to and would be the
exposure

limit during the period in which TCE is still in use until its eventual
prohibition. EPA requests comment on setting such an interim level for
TCE based on a limit of detection that is the lowest limit of detection
using analytical methods developed by OSHA/NIOSH for personal breathing
zone monitoring. More specifically, EPA requests comment on using OSHA
Method 1001, which has a personal breathing zone limit of detection for
TCE of 18 ppb, or 0.018 ppm, to set an interim exposure limit of 0.036
ppm, with an action level of 0.018 ppm (Ref. 46).
    Under this approach, EPA would initially establish an exposure
value that would be technically feasible to detect in the near-term,
with a step down to the ECEL at a later date, until the applicable
prohibition would take effect. This approach would significantly reduce
exposures to TCE from the current OSHA PEL of 100 ppm by establishing
an interim exposure value of 0.036 ppm and action level of 0.018 ppm,
until advancements in technologies reliably support measurement at the
ECEL or below. EPA requests comments that provide supported
recommendations for one or more incremental exposure values and
associated timelines for achieving the incremental exposure levels and
the currently proposed ECEL of 0.0011 ppm, and comments that consider
and provide information on the needed advancements in exposure
monitoring methods, analytical methods, and exposure controls,
including expected timelines for developing these capabilities.
    The proposed requirements would be applicable to owners and
operators of workplaces where manufacturing (including import),
processing, and industrial and commercial use of TCE would be permitted
to continue more than 1 year after the publication of the final rule.
The proposed requirements would be applicable from the date of
publication of the final rule until the prohibition compliance date for
those conditions of use. However, the proposed requirements of the WCPP
would not be applicable to owners and operators of workplaces where EPA
is proposing to prohibit manufacturing and processing for certain
industrial and commercial use and consumer uses within 1 year of the
effective date of the final rule. The WCPP would also not be applicable
to owners and operators of workplaces where EPA is proposing to
prohibit distribution in commerce or disposal to industrial pre-
treatment, industrial treatment, or publicly owned treatment works.
    As described further in Unit VI.A.1., EPA believes that long-term
implementation of the WCPP for continued use of TCE is not a feasible
means of addressing unreasonable risk such that prohibition ultimately
would be necessary to address the unreasonable risk.
ii. Monitoring Requirements
    Overview. Monitoring requirements are a key component of
implementing EPA's proposed WCPP. Initial monitoring for TCE would be
critical for establishing a baseline of exposure for potentially
exposed persons and for identifying the lowest achievable exposure
level in a facility; similarly, periodic exposure monitoring would
assure that exposures continue to be reduced to the lowest level
achievable so that unreasonable risk of injury is reduced for
potentially exposed persons in the workplace. Periodic exposure
monitoring frequency could change if certain conditions are met, which
are described in this unit. Additionally, in some cases, a change in
workplace conditions with the potential to impact exposure levels would
warrant additional monitoring, which is also described. To ensure
compliance with monitoring activities, EPA proposes exposure monitoring
recordkeeping requirements outlined in this unit.
    Initial exposure monitoring. Under the proposed regulation, each
owner or operator of a workplace where any condition of use subject to
a WCPP is occurring would be required to perform initial exposure
monitoring to determine the extent of exposure of potentially exposed
persons to TCE. Initial monitoring would notify owner or operators of
the magnitude of possible exposures, to their potentially exposed
persons with respect to their unique work conditions and environments.
The results of the initial exposure monitoring would be used to help
determine the lowest achievable level in a facility, the frequency of
future periodic monitoring, whether additional exposure controls are
necessary (such as engineering controls, administrative controls, and/
or respiratory protection), and whether the owner or operator would
need to demarcate a regulated area as described in this unit.
    EPA is proposing to require each owner or operator to establish an
initial baseline monitoring sample to determine the magnitude of
exposure for all persons who may be exposed to TCE within 180 days (6
months) after the date of publication of the final rule in the Federal
Register. Where TCE is present in the workplace, each owner or operator
would be required to determine each potentially exposed person's
exposure by either taking a personal breathing zone air sample of each
potentially exposed person or taking personal breathing zone air
samples that are representative of each potentially exposed person's
exposure performing the same or substantially similar operations in
each work shift, in each job classification, and in each work area
(hereinafter identified as an ``exposure group''). Representative 8-
hour TWA exposures must be determined based on one or more samples
representing full-shift exposures for each shift for each person in
each job classification in each work area. Monitoring samples must be
taken when and where the operating conditions are best representative
of each potentially exposed person's full-shift exposures, and also
must represent the highest TCE exposures likely to occur under
reasonably foreseeable conditions of use. EPA expects that owners and
operators would attempt to monitor a baseline for all of the tasks
during the same timeframe; however, EPA understands that certain tasks
occur less frequently, and EPA is soliciting comments regarding the
timing of the initial exposure monitoring so that it would be
representative of all tasks involving TCE where exposures may approach
the ECEL. If the owner or operator chooses a representative sample,
such sampling must include persons that are the closest to the source
of TCE, so that the monitoring results are representative of the most
highly exposed persons in the workplace. EPA is also soliciting
comments regarding use of area source monitoring instead of personal
breathing zone as a representative sample of exposures.
    EPA also recognizes that some entities may already have exposure
monitoring data. If the owner or operator has monitoring data conducted
within five years prior to the effective date of the final rule and the
monitoring would satisfy the monitoring requirements described in this
unit, including the requirement that the data represent the highest TCE
exposures likely to occur under reasonably foreseeable conditions of
use, the owner or operator may rely on such earlier monitoring results
for the initial baseline monitoring sample.
    EPA proposes to require each owner or operator to perform exposure
monitoring to identify the lowest achievable exposure level in relation
to the ECEL value, and ensure to the extent possible (supported by
documentation further described in Unit V.A.2.d.i) that no person is
exposed to an airborne concentration of TCE in exceedance of

the ECEL. EPA requests comment on how owners and operators should
identify the lowest achievable exposure level, what documentation would
be needed to support that further reductions are not possible, and
whether EPA should provide a definition of meeting the ECEL to the
extent possible. Additionally, EPA requests comment on whether current
monitoring methods (Ref. 13) are able to detect airborne concentrations
at the ECEL and action level values. EPA expects that detection and
adherence to extremely low-ppm levels of TCE may present challenges to
some in the regulated community; therefore, EPA is also requesting
comment on whether EPA should propose specific requirements following
results indicating non-detectable concentrations of TCE (non-detects),
or a requirement that a specific monitoring method be used.
    Periodic exposure monitoring. EPA is proposing to require each
owner or operator to conduct, for those exposure groups that exceed the
following airborne concentration levels, the following periodic
monitoring:
     If all samples taken during the initial exposure
monitoring reveal a concentration below the ECEL action level (0.00055
ppm 8-hour TWA), the owner or operator must repeat the periodic
exposure monitoring at least once every five years.
     If the initial or most recent exposure monitoring
indicates that airborne exposure is above the ECEL (0.0011 ppm 8-hour
TWA), the owner or operator must repeat the periodic exposure
monitoring within 3 months of the most recent exposure monitoring.
     If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (0.00055 ppm 8-
hour TWA) but at or below the ECEL (0.0011 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within 6
months of the most recent exposure monitoring.
     If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owners or operators must repeat such monitoring within 6 months of the
most recent monitoring until two consecutive monitoring measurements
taken at least seven days apart, are below the ECEL action level
(0.00055 ppm 8-hour TWA), at which time the owner or operator must
repeat the periodic exposure monitoring at least once every 5 years.
    Additionally, in instances where an owner or operator does not
manufacture, process, distribute, or use TCE for a condition of use for
which the WCPP is proposed over the entirety of time since the last
required periodic monitoring event, EPA is proposing that the owner or
operator would be permitted to forgo the next periodic monitoring
event. However, documentation of cessation of use of TCE would be
required and periodic monitoring would be required to resume should the
owner or operator restart any of the conditions of use listed in Unit
V.A.2. for which the WCPP is proposed as a workplace protection
measure.
    The proposed periodic monitoring requirements are also outlined in
Table 1. EPA requests comment on the timeframes for periodic monitoring
outlined in this unit. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments. EPA
requests comment on the ability for a facility to perform the proposed
periodic monitoring requirements, specifically whether monitoring
methods can detect the ECEL action level and ECEL value.

                Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
      Air concentration condition        Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is    Periodic exposure monitoring is
 below the ECEL action level (<0.00055    required at least once every 5
 ppm 8-hour TWA).                         years.
If the initial or most recent exposure   Periodic exposure monitoring is
 monitoring indicates that airborne       required within 3 months of
 exposure is above the ECEL (>0.0011      the most recent exposure
 ppm 8-hour TWA).                         monitoring.
If the initial or most recent exposure   Periodic exposure monitoring is
 monitoring indicates that airborne       required within 6 months of
 exposure is at or above the ECEL         the most recent exposure
 action level but at or below the ECEL    monitoring.
 (>=0.55 ppb 8-hour TWA, <=0.0011 ppm 8-
 hour TWA).
If the two most recent (non-initial)     Periodic exposure monitoring is
 exposure monitoring measurements,        required within 5 years of the
 taken at least seven days apart within   most recent exposure
 a 6-month period, indicate that          monitoring.
 airborne exposure is below the ECEL
 action level (<0.00055 ppm 8-hour TWA).
If the owner or operator engages in a    The owner or operator may forgo
 condition of use for which compliance    its current periodic
 with the WCPP would be required but      monitoring event. However,
 does not manufacture, process, use, or   documentation of cessation of
 dispose of TCE in that condition of      use of TCE as well as periodic
 use over the entirety of time since      monitoring would be required
 the last required monitoring event.      when the owner or operator
                                          resumes or starts any of the
                                          conditions of use for which
                                          compliance with the WCPP is
                                          proposed.
------------------------------------------------------------------------

    Additional exposure monitoring. In addition to the initial and
periodic exposure monitoring, EPA is proposing that each owner or
operator conduct additional exposure monitoring whenever a change in
the production, process, control equipment, personnel, or work
practices that may reasonably be expected to result in new or
additional exposures at or above the ECEL action level, or when the
owner or operator has any reason to believe that new or additional
exposures at or above the ECEL action level have occurred. In the event
of start-up, shutdown, spills, leaks, ruptures or other breakdowns that
may lead to employee exposure, EPA is proposing that each owner or
operator must conduct additional initial exposure monitoring to
potentially exposed persons (using personal breathing zone sampling)
after the cleanup of the spill or repair of the leak, rupture or other
breakdown. An additional exposure monitoring event may result in an
increased frequency of periodic monitoring. For example, if the initial
monitoring results from a workplace are above the ECEL action level,
but below the ECEL, periodic monitoring is required every 6 months. If
additional monitoring is performed because increased exposures are
suspected, and the results are above the ECEL, subsequent periodic
monitoring would have to be performed every 3 months. The required
additional exposure monitoring should not delay implementation of any
necessary cleanup or other remedial action to reduce the exposures to
persons in the workplace.

    Other monitoring requirements. For each monitoring event, EPA is
proposing to require owners or operators ensure that their methods be
accurate, to a confidence level of 95 percent, to within plus or minus
25 percent for airborne concentrations of TCE. Also, EPA is proposing
to require use of appropriate sampling and analytical methods used to
determine TCE exposure, including as relevant: (A) Use of an analytical
method already approved by EPA, OSHA or NIOSH, or another analytical
method that has been demonstrated to meet the proposed accuracy
requirement at an appropriate limit of detection for the ECEL and ECEL
action level; (B) Compliance with the Good Laboratory Practice
Standards at 40 CFR part 792. Additionally, EPA is proposing to require
owners and operators to re-monitor within 15 working days after receipt
of the results of any exposure monitoring when results indicate non-
detect or air monitoring equipment malfunction, unless an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist reviews the monitoring results and determines re-monitoring
is not necessary.
    EPA is also proposing to require that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
    (A) Dates, duration, and results of each sample taken;
    (B) All measurements that may be necessary to determine the
conditions (e.g., work site temperatures, humidity, ventilation rates,
monitoring equipment type and calibration dates) that may affect the
monitoring results;
    (C) Name, workplace address, work shift, job classification, and
work area of the person monitored; documentation of all potentially
exposed persons whose exposures the monitoring is intended to represent
if using a representative sample; and type of respiratory protective
device worn by the monitored person, if any;
    (D) Use of appropriate sampling and analytical methods, such as
analytical methods already approved by EPA, OSHA or NIOSH, or
compliance with an analytical method verification procedure;
    (E) Compliance with the Good Laboratory Practice Standards at 40
CFR part 792; and
    (F) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
iii. Incorporation of the Hierarchy of Controls
    EPA is proposing to require owners or operators to implement the
WCPP in accordance with the hierarchy of controls and encourages the
use of pollution prevention to control exposures whenever practicable.
Pollution prevention, also known as source reduction, is any practice
that reduces, eliminates, or prevents pollution at its source (e.g.,
elimination and substitution). Similarly, the hierarchy of controls
includes, in order of preference, elimination, substitution,
engineering controls, and administrative controls, prior to relying on
PPE as a means of controlling exposures (Ref. 12). EPA is proposing to
require owners or operators to reduce inhalation exposures below the
ECEL in accordance with the hierarchy of controls to the extent
possible as supported by documentation further described in Unit
V.A.2.d.i.). EPA expects that, for conditions of use for which EPA is
proposing a WCPP as a protection measure, compliance at most workplaces
would be part of an existing industrial hygiene program. Workplaces
would have to institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
reduce exposures to the extent feasible (Ref. 12). If an owner or
operator chooses to replace TCE with a substitute, EPA recommends that
they carefully review the available hazard and exposure information on
the potential substitutes to avoid a regrettable substitution.
    If an effort to identify and implement feasible exposure controls,
in accordance with the hierarchy of controls, such as elimination,
substitution, engineering controls, and administrative controls is
found not to be sufficient to reduce exposures to or below the ECEL for
all persons in the workplace, EPA proposes to require each owner or
operator to use such controls to reduce TCE concentrations in the
workplace to the lowest levels achievable and, only after levels cannot
be further reduced, supplement these controls using respiratory
protection before persons are permitted to enter a regulated area, as
described in this unit. In such cases, EPA would require that the owner
or operator provide those persons exposed or who may be exposed to TCE
by inhalation above the ECEL with respirators so that exposures can be
reduced to the extent possible (supported by documentation further
described in Unit V.A.2.d.i.). EPA also proposes to require that each
owner or operator document their evaluation of elimination,
substitution, engineering and administrative exposure control
strategies and, if applicable, the reasons why they found these
strategies infeasible to control exposures below the ECEL, in an
exposure control plan as described in this unit. In addition, a
regulated entity would be prohibited from rotating work schedules of
potentially exposed persons to comply with the ECEL 8-hour TWA. EPA may
require more, less, or different documentation regarding exposure
control strategies in the final rule based on consideration of public
comments. The Agency understands that certain engineering controls can
reduce exposures to people inside the workplace but may lead to
increased ventilation of TCE outside of the workplace, thereby
potentially increasing risks of adverse health effects from exposures
to TCE in ambient air to people in fenceline communities. EPA expects
that processing and commercial use of TCE for the conditions of use for
which the WCPP would apply will decrease ahead of the prohibition
compliance dates (Ref. 3) and therefore expects that any risks to
fenceline communities would also decrease. More information on EPA's
analysis of ambient air and water pathways is in Unit VII.A. To
understand more fully the potential impacts to fenceline communities of
requirements to reduce workplace exposure to TCE, EPA is requesting
comment on whether industry anticipates increased releases of TCE to
outdoor air associated with the implementation of the WCPP. In order to
avoid unintended increases in exposures to people from TCE emissions to
ambient air, EPA requests comment on whether owners and operators
should be required to attest in their exposure control plan that
engineering controls selected do not increase emissions of TCE to
ambient air outside of the workplace and document in their exposure
control plan whether additional equipment was installed to capture
emissions of TCE to ambient air. EPA requests comment on how such a
requirement could impact the availability, feasibility, or cost of
engineering controls as a means to reduce workplace exposures to or
below the proposed ECEL.
iv. Regulated Area
    Based on the exposure monitoring, EPA is proposing to require that
owners or operators of workplaces subject to a WCPP as a protection
measure demarcate any area where airborne concentrations of TCE exceed
or are reasonably expected to exceed the ECEL. Regulated areas would be

demarcated using administrative controls, such as warning signs or
highly visible signifiers, in multiple languages as appropriate (e.g.,
based on languages spoken by potentially exposed persons), placed in
conspicuous areas, and documented through training and recordkeeping.
The owner or operator would be required to restrict access to the
regulated area from anyone who is not an authorized user, which
includes any potentially exposed person that lacks proper training, is
not wearing required PPE as described in this unit or is otherwise
unauthorized to enter. EPA is proposing to require owners and operators
demarcate a regulated area, beginning 9 months after the date of
publication of the final rule, or within 3 months after receipt of any
exposure monitoring that indicates exposures exceeding the ECEL. EPA is
soliciting comment on requiring warning signs to demarcate regulated
areas, such as the requirements found in OSHA's General Industry
Standard for Beryllium (29 CFR 1910.1024(m)(2)). EPA is also requesting
comment on whether the owner or operator should be required to permit
designated representatives of employees and other workers to enter
regulated areas to observe exposure monitoring similar to typical OSHA
Standard requirements, e.g., 29 CFR 1910.1024(d)(7).
v. Notification of Monitoring Results
    EPA proposes that the owner or operator must, within 15 working
days after receipt of the results of any exposure monitoring, notify
each person whose exposure is represented by that monitoring in
writing, either individually to each potentially exposed person or by
posting the information in an appropriate and accessible location, such
as public spaces or common areas, outside the regulated area. This
notice must include the exposure monitoring results, identification and
explanation of the ECEL and ECEL action level in plain language,
identification of the lowest achievable exposure level, if applicable,
any corresponding required respiratory protection, if applicable, the
quantity, location, manner of TCE use and identified releases of TCE
that could result in exposure to TCE, and whether the airborne
concentration of TCE exceeds the ECEL. The notice must also include a
description of actions taken by the owner or operator to reduce
inhalation exposures to or below the ECEL, if applicable, or refer to a
document available to the potentially exposed persons which states the
actions to be taken to reduce exposures. The notice would be required
to be posted in multiple languages if necessary (e.g., notice must be
in a language that the potentially exposed person understands,
including a non-English language version representing the language of
the largest group of workers who cannot readily comprehend or read
English).
c. Personal Protective Equipment (PPE) Program
    Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL for all potentially exposed persons,
EPA is proposing to require implementation of a PPE program in
alignment with OSHA's General Requirements for Personal Protective
Equipment at 29 CFR 1910.132. Consistent with 29 CFR 1910.132, owners
and operators would be required to provide PPE, including respiratory
protection and dermal protection selected in accordance with the
guidelines described in this unit, that is of safe design and
construction for the work to be performed. EPA is proposing to require
owners and operators ensure each potentially exposed person who is
required by this unit to wear PPE to use and maintain PPE in a
sanitary, reliable, and undamaged condition. Owners and operators would
be required to select and provide PPE that properly fits each
potentially exposed person who is required by this unit to use PPE and
communicate PPE selections to each affected person.
    As part of the PPE program, EPA is also proposing that owners and
operators must comply with OSHA's general PPE training requirements at
29 CFR 1910.132(f) for application of a PPE training program, including
providing training on proper use of PPE (e.g., when and where PPE is
necessary, proper application, wear, and removal of PPE, maintenance,
useful life, and disposal of PPE). EPA is proposing that owners and
operators would provide PPE training to each potentially exposed person
who is required by this unit to wear PPE prior to or at the time of
initial assignment to a job involving potential exposure to TCE. Owners
and operators would also have to re-train each affected person at least
once annually or whenever the owner or operator has reason to believe
that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in the PPE to be used render the previous training
obsolete.
    This unit includes a description of the PPE Program, including
proposed PPE as it relates to respiratory protection, proposed PPE as
it relates to dermal protection, and other proposed requirements such
as additional training for respirators and recordkeeping to support
implementation of a PPE program.
i. Respiratory Protection
    Where elimination, substitution, engineering and administrative
controls are not feasible to reduce the air concentration to or below
the ECEL, EPA proposes to set minimum respiratory PPE requirements
based on an entity's most recent measured air concentration and the
level of PPE that EPA determined would be needed to reduce exposure to
the ECEL. In those circumstances, EPA is proposing to require a
respiratory protection PPE program with worksite-specific procedures
and elements for required respirator use. The respiratory protection
PPE program proposed by EPA would be based on the most recent exposure
monitoring concentration measured as an 8-hour TWA and would be
administered by a suitably trained program administrator. EPA is also
proposing to require each owner or operator select respiratory
protection in accordance with the guidelines described in this unit and
29 CFR 1910.134(a) through (l), except (d)(1)(iii), for proper
respirator use, maintenance, fit-testing, medical evaluation, and
training. EPA is not proposing to cross reference 29 CFR
1910.134(d)(1)(iii) because the WCPP contains requirements for
identifying TCE respiratory hazards in the workplace.
    Required Respiratory Protection. EPA is proposing to require each
owner or operator supply a respirator, selected in accordance with this
unit, to each person who enters a regulated area within 3 months after
the receipt of any exposure monitoring that indicates exposures
exceeding the ECEL and thereafter must ensure that all persons within
the regulated area are using the provided respirators whenever TCE
exposures exceed or can reasonably be expected to exceed the ECEL.
Given the risks associated with TCE exposure above the ECEL, prompt
compliance with the respiratory protection requirements is important,
but EPA expects that most owners or operators will need some time after
the exposure monitoring results are received to acquire the correct
respirators and establish a respiratory protection program, including
training, fit-testing, and medical evaluations. While EPA believes that
3 months should be sufficient for this purpose, EPA is seeking comment
on whether this timeframe should be shorter (e.g.,

within two weeks after the receipt of any exposure monitoring that
indicates exposure exceeding the ECEL), given the severity of the
effect. EPA is also proposing that owners or operators who would be
required to administer a respiratory protection program must supply a
respirator selected in accordance with 29 CFR 1910.134(d)(1) (except
(d)(1)(iii)). Additionally, EPA is proposing that the owner or operator
must ensure that all filters, cartridges, and canisters used in the
workplace are labeled and color coded with the NIOSH approval label and
that the label is not removed and remains legible. 29 CFR
1910.134(d)(3)(iii), which EPA is proposing to cross-reference,
requires either the use of respirators with an end-of-life service
indicator certified by NIOSH for the contaminant, in this case TCE, or
implementation of a change schedule for canisters and cartridges that
ensures that they are changed before the end of their service life. EPA
is requesting comment on whether there should be a requirement to
replace cartridges or canisters after a certain number of hours, such
as the requirements found in OSHA's General Industry Standard for 1,3-
Butadiene (29 CFR 1910.1051(h)), or a requirement for a minimum service
life of non-powered air-purifying respirators such as the requirements
found in OSHA's General Industry Standard for Benzene (29 CFR
1910.1028(g)(3)(D)).
    EPA is proposing the following requirements for respiratory
protection, based on the exposure monitoring concentrations measured as
an 8-hour TWA that exceed the ECEL (0.0011 ppm). EPA is proposing to
establish minimum respiratory protection requirements, such that any
respirator affording a higher degree of protection than the following
proposed requirements may be used. This unit includes respirator
selection requirements for respirators of assigned protection factors
(APFs) of 1,000 or greater.
     If the measured exposure concentration is at or below
0.0011 ppm (1.1 ppb): no respiratory protection is required.
     If the measured exposure concentration is above 0.0011 ppm
(1.1 ppb) and less than or equal to 0.0055 ppm (5.5 ppb) (5 times
ECEL): Any NIOSH-certified air-purifying quarter mask respirator (APF
5).
     If the measured exposure concentration is above 0. 0055
ppm (5.5 ppb) and less than or equal to 0.011 ppm (11.0 ppb) (10 times
ECEL): Any NIOSH-certified air-purifying half mask or full facepiece
respirator equipped with NIOSH-approved organic vapor cartridges or
canisters; or any negative pressure (demand mode) supplied air
respirator equipped with a half mask (APF 10).
     If the measured exposure concentration is above 0.0011 ppm
(1.1 ppb) and less than or equal to 0.0275 ppm (27.5 ppb) (25 times
ECEL): Any NIOSH-certified air-purifying full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters; any
NIOSH-certified powered air-purifying respirator equipped with NIOSH-
approved organic vapor cartridges; or any NIOSH-certified continuous
flow supplied air respirator equipped with a hood or helmet (APF 25).
     If the measured exposure concentration is above 0.0275 ppm
(27.5 ppb and less than or equal to 0.055 ppm (55.0 ppb) (50 times
ECEL): Any NIOSH-certified air-purifying full facepiece respirator
equipped with NIOSH-approved organic vapor cartridges or canisters; any
NIOSH-certified powered air-purifying respirator equipped with a tight-
fitting half facepiece and NIOSH-approved organic vapor cartridges or
canisters; any NIOSH-certified negative pressure (demand mode)
supplied-air respirator equipped with a full facepiece; any NIOSH-
certified continuous flow supplied-air respirator equipped with a
tight-fitting half facepiece; any NIOSH-certified pressure-demand or
other positive pressure mode supplied-air respirator equipped with a
tight-fitting half facepiece; or any NIOSH-certified negative pressure
(demand mode) self-contained breathing apparatus respirator equipped
with a full facepiece (APF 50).
     If the measured exposure concentration is above 0.055 ppm
(55.0 ppb) and less than or equal to 1.1 ppm (1,100 ppb) (1,000 times
ECEL): Any NIOSH-certified powered air-purifying respirator equipped
with a full facepiece and NIOSH-approved organic vapor cartridges or
canisters; or any NIOSH-certified supplied air respirator equipped with
a full facepiece and operated in a continuous flow mode or pressure
demand or other positive pressure mode (APF 1,000).
     If the measured exposure concentration is greater than 1.1
ppm (1,100 ppb) (1,000 times ECEL) or the concentration is unknown: Any
NIOSH-certified self-contained breathing apparatus (SCBA) equipped with
a full facepiece and operated in a pressure demand or other positive
pressure mode; or any NIOSH-certified supplied air respirator equipped
with a full facepiece and operated in a pressure demand or other
positive pressure mode in combination with an auxiliary SCBA operated
in a pressure demand or other positive pressure mode (APF 10,000).
    EPA proposes to require that owners and operators document
respiratory protection used and PPE program implementation. EPA
proposes to require that owners and operators document in the exposure
control plan or other documentation of the facility's safety and health
program information relevant to respiratory program, including records
on the name, workplace address, work shift, job classification, work
area, and type of respirator worn (if any) by each potentially exposed
person, maintenance, and fit-testing, as described in 29 CFR
1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29
CFR 1910.134(k).
ii. Dermal Protection
    EPA is proposing to require use and provision of chemically
resistant gloves by potentially exposed persons in combination with
specific activity training (e.g., glove selection (type, material),
expected duration of glove effectiveness, actions to take when glove
integrity is compromised, storage requirements, procedure for glove
removal and disposal, chemical hazards) for tasks where dermal exposure
can be expected to occur. EPA is proposing that owners and operators
must also consider other glove factors, such as compatibility of
multiple chemicals used simultaneously while wearing TCE-resistant
gloves or with glove liners, permeation, degree of dexterity required
to perform a task, and temperature, as identified in the Hand
Protection section of OSHA's Personal Protection Equipment Guidance
(Ref. 47), when selecting appropriate PPE. Furthermore, owners and
operators can select gloves that have been tested in accordance with
the American Society for Testing Material (ASTM) F739 ``Standard Test
Method for Permeation of Liquids and Gases through Protective Clothing
Materials under Conditions of Continuous Contact.'' EPA requests
comment on the degree to which additional guidance related to use of
gloves might be necessary. Additionally, EPA requests comment on
whether EPA should incorporate additional dermal protection
requirements into the exposure control plan or require consideration of
the hierarchy of controls for dermal exposures.
d. General WCPP Requirements
i. Exposure Control Plan
    EPA proposes to require that owners and operators document their
exposure control strategy and implementation in

an exposure control plan or through adding EPA-required information to
any existing documentation of the facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards. EPA proposes to require that each owner or operator
document in the exposure control plan the following:
    (A) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of TCE, substitution of
TCE, engineering controls, and administrative controls to reduce
exposures in the workplace to either at or below the ECEL or to the
lowest level achievable for TCE in the workplace;
    (B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
    (C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
    (D) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
    (E) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL or
lowest achievable exposure level;
    (F) Identification of the lowest achievable exposure level and why
further reductions are not possible;
    (G) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
    (H) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or lowest achievable exposure level and subsequent corrective
actions taken during start-up, shutdown, or malfunctions to mitigate
exposures to TCE; and
    (I) Availability of the exposure control plan and associated
records for potentially exposed persons.
ii. Workplace Information and Training
    EPA is also proposing to require implementation of a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with TCE
exposure, EPA is proposing to require that owners or operators of
workplaces subject to the WCPP institute a training and information
program for potentially exposed persons and assure their participation
in the training and information program.
    As part of the training and information program, the owner or
operator would be required to provide information and comprehensive
training in an understandable manner (i.e., plain language) and in
multiple language as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons prior to or
at the time of initial assignment to a job involving potential exposure
to TCE. In alignment with the OSHA Hazard Communication Standard,
owners and operators would be required to provide information and
training to all potentially exposed persons that includes (A) the
requirements of the TCE WCPP and how to access or obtain a copy of the
requirements of the WCPP; (B) the quantity, location, manner of use,
release, and storage of TCE and the specific operations in the
workplace that could result in TCE exposure; (C) principles of safe use
and handling of TCE in the workplace, including specific measures the
owner or operator has implemented to reduce inhalation exposures or
prevent dermal contact with TCE, such as work practices and PPE used;
(D) the methods and observations that may be used to detect the
presence or release of TCE in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of TCE when being released, etc.); and (E)
the health hazards associated with exposure to TCE.
    In addition to providing training at the time of initial assignment
to a job involving potential exposure to TCE, and in alignment with the
OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners
and operators subject to the TCE WCPP would be required to re-train
each potentially exposed person annually to ensure they understand the
principles of safe use and handling of TCE in the workplace. Owners and
operators would also need to update the training as necessary whenever
there are changes in the workplace, such as new tasks or modifications
of tasks, in particular, whenever there are changes in the workplace
that increase exposure to TCE or where potentially exposed persons'
exposure to TCE can reasonably be expected to exceed the action level.
To support compliance, EPA is proposing that each owner or operator of
a workplace subject to the WCPP would be required to provide to the
EPA, upon request, all available materials related to workplace
information and training.
iii. Workplace Participation
    EPA encourages owners or operators to consult with persons that
have potential for exposure on the development and implementation of
exposure control plans and PPE/respirator programs. EPA is proposing to
require owners or operators to provide potentially exposed persons or
their designated representatives regular access to the exposure control
plans, exposure monitoring records, and PPE program implementation and
documentation. To ensure compliance in workplace participation, EPA is
proposing that the owner or operator document the notice to and ability
of any potentially exposed person that may reasonably be affected by
TCE inhalation exposure or dermal contact with TCE to readily access
the exposure control plans, facility exposure monitoring records, PPE
program implementation, or any other information relevant to TCE
inhalation or dermal exposure in the workplace. EPA is requesting
comment on how owners and operators can engage with potentially exposed
persons on the development and implementation of an exposure control
plan and PPE program.
iv. Recordkeeping
    To support and demonstrate compliance, EPA is proposing that each
owner or operator of a workplace subject to WCPP retain compliance
records for five years. EPA is proposing to require records to include:
    (A) the exposure control plan;
    (B) PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
    (C) information and training provided to each person prior to or at
the time of initial assignment and any re-training.
    In addition, EPA is proposing that owners and operators subject to
the WCPP requirements maintain records to include:
    (D) The exposure monitoring records;
    (E) Notification of exposure monitoring results; and
    (F) To the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the proposed WCPP requirements.
    The owners and operators, upon request by EPA, would be required to
make all records that are maintained as

described in this unit available to EPA for examination and copying in
accordance with EPA requirements. All records required to be maintained
by this unit could be kept in the most administratively convenient form
(electronic or paper).
v. Compliance Timeframes
    EPA is proposing to require each owner or operator of a workplace
subject to an ECEL conduct initial baseline monitoring according to the
process outlined in this unit by 6 months after date of publication of
the final rule in the Federal Register. EPA is proposing to require
each owner or operator ensure that the airborne concentration of TCE
does not exceed the ECEL or lowest achievable exposure level for all
potentially exposed persons within 9 months after the date of
publication of the final rule in the Federal Register, and if
applicable, each owner or operator must provide respiratory protection
sufficient to reduce inhalation exposures to below the ECEL to all
potentially exposed persons in the regulated area within 3 months after
receipt of the results of any exposure monitoring that indicates
exposures exceeding the ECEL or, if using monitoring data conducted
within five years prior to the effective date of the final rule that
satisfies all other requirements of the proposed WCPP, within 9 months
after the date of publication of the final rule in the Federal
Register. EPA is also proposing to require owners and operators
demarcate a regulated area within 3 months after receipt of any
exposure monitoring that indicates exposures exceeding the ECEL.
Regulated entities should then proceed accordingly to implement an
exposure control plan within 12 months after date of publication of the
final rule in the Federal Register. EPA requests comment relative to
the ability of owners or operators to conduct initial monitoring within
6 months after date of publication of the final rule in the Federal
Register, and anticipated timeframes for any procedural adjustments
(i.e., use of new technologies for personal breathing zone monitoring
at extremely low-ppm levels of TCE) needed to comply with the
requirements outlined in this unit, including establishment of a
respiratory protection program and development of an exposure control
plan.
    EPA understands that the regulated community may have difficulty
measuring at or below the ECEL consistently over an entire work shift.
Therefore, EPA is requesting comment regarding the amount of time, if
any, it would take the regulated community to develop a method to
measure at or below the ECEL over an entire work shift. EPA is
interested in what levels of detection are possible based on existing
monitoring methods, justification for the timeframe of the specific
steps needed to develop a more sensitive monitoring method, and any
additional detailed information related to establishing a monitoring
program to reliably measure TCE at or below the ECEL.
    With regard to the compliance timeframe for those occupational
conditions of use which are subject to dermal protection requirements,
EPA is proposing to require each owner or operator of a workplace
subject to dermal protection requirements to establish dermal
protection outlined in this unit by 6 months after publication of the
final rule in the Federal Register. EPA requests comment relative to
the ability of owners or operators to implement dermal protection
within 6 months of publication of the final rule in the Federal
Register, and anticipated timeframes for any procedural adjustments
needed to comply with the requirements outlined in this unit. EPA may
finalize shorter or longer compliance timeframes based on consideration
of public comments.
3. TSCA Section 6(g) Exemptions
    Under TSCA section 6(g)(1), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if the Agency makes one of three
findings. TSCA section 6(g)(1)(A) permits such an exemption if the
specific condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available.
Under TSCA section 6(g)(1)(B), EPA must find that compliance with the
requirement would significantly disrupt the national economy, national
security, or critical infrastructure to provide an exemption. Finally,
TSCA section 6(g)(1)(C) allows for an exemption based on an EPA finding
that the specific condition of use of the chemical substance or
mixture, as compared to reasonably available alternatives, provides a
substantial benefit to health, the environment, or public safety. Based
on discussions and information provided by industry stakeholders and
consultation with DOD and NASA, EPA has analyzed the need for several
different exemptions and is proposing to grant six. This unit presents
the results of that analysis.
    Pursuant to TSCA section 6(g)(3), if an exemption is finalized, EPA
may by rule later extend, modify, or eliminate the exemption, on the
basis of reasonably available information and after adequate public
justification, if EPA determines the exemption warrants a change. EPA
will initiate this rulemaking process at the request of any regulated
entity benefiting from such an exemption. The Agency is open to
engagement throughout the duration of any TSCA section 6(g) exemption
and emphasizes that, to ensure continuity in the event of an extension
or modification, such a request should come at least two years prior to
the expiration of an exemption.
a. Analysis of the Need for TSCA Section 6(g)(1) Exemptions for Uses of
TCE That Are Critical or Essential
i. Analysis of the Need for a TSCA Section 6(G)(1)(B) Exemption for
Industrial and Commercial Use of TCE as a Processing Aid for Battery
Separator Manufacturing (Lead-Acid And Lithium Battery Separators)
    As part of industry stakeholder engagement and interagency
consultation with other Federal agencies following publication of the
2020 Risk Evaluation for TCE (Ref. 35 stakeholder meeting list), EPA
was made aware that some U.S. battery separator manufacturers continue
to rely on TCE to manufacture specialty separator materials of lead-
acid and lithium batteries (Refs. 48, 49). In the 2020 Risk Evaluation
for TCE, EPA evaluated the industrial and commercial use of TCE as a
processing aid for battery separator manufacturing. EPA understands
that the manufacture of battery separators takes place separately from
overall battery manufacture, that both lead-acid and lithium batteries
require separators for operation, and that the lead-acid and lithium
battery separator manufacturing processes are highly engineered
specialty products manufactured with precision to stringent technical
specifications essential to power vehicles and systems in the U.S.
supply chain for multiple critical infrastructure sectors within the
national economy.
    EPA understands that separators are fundamental components in
batteries that provide the necessary separation between the internal
anode and cathode components that make batteries work, and that a
restriction on TCE use for the production of battery separators would
critically impact the U.S. battery manufacturing supply chain and
impede the expansion of domestic battery production capacity (Refs. 50,
51). Industry stakeholders as well as other Federal agencies have
discussed with EPA the potential adverse implications of banning or
severely restricting use of TCE for battery separator production, as it
would

disrupt the supply chain and leave the U.S. reliant on foreign
suppliers to the extent that they are available to support the national
economy, national security, and critical infrastructure (Refs. 48, 49).
EPA agrees these assertions have merit. Lead-acid and lithium batteries
are essential to serve critical infrastructure such as transportation
systems, security systems, as well as to energize the national defense
base (e.g., nuclear submarine batteries). Two companies requested that
EPA provide exemptions under TSCA section 6(g) to allow for the
continued use of TCE in the manufacture of battery separators, noting
their significant concern about potential prohibitions under TSCA on
the use of TCE. Both companies emphasized the need for the continued
use of TCE in the manufacture of battery separators to strengthen
critical supply chains by revitalizing domestic manufacturing and
research and development in accordance with Executive Order 14017 (86
FR 11849, March 1, 2021). Additionally, the companies noted that a
potential ban on TCE would be contrary to the Administration's national
security priorities, which are to reduce supply chain risks by building
a robust domestic renewable power sector, transitioning to a clean
energy-based economy, growing a mature and competitive high-capacity
battery industry, and leading global innovation and production in
advanced technology products through a strong domestic manufacturing
base.
    One company requested a TSCA section 6(g) exemption for the use of
TCE and described the specific use of TCE as an ``extraction solvent''
during the separator manufacturing process for both lead-acid and
lithium battery separators (Ref. 48). The company makes lead-acid and
lithium battery separators from naphthenic process oil during the
extrusion process in order to form a thin sheet or film for each
separator. During the extrusion process, a precise amount of process
oil must be removed from the separator, which requires the use of a
solvent (i.e., TCE) to rapidly extract the process oil and leave behind
the desired porosity to allow ion flow in each finished battery. The
finished separators must contain a specific percentage of residual
process oil that ranges between 15% to 20% for lead-acid battery
separators (for oxidation resistance in the finished battery) and less
than 1% for lithium separators. Once the solvent has removed the
precise amount of oil from each separator, the solvent must be
evaporated/removed from the separator, and post-evaporation, the
separator must have the specific porosity and wettability to provide
low electrical (ionic) resistance (i.e., enabling ion transport) within
a battery. For these established separator manufacturing processes, TCE
is a high-performance process solvent that provides a unique
combination of chemical properties (e.g., non-flammability, rapid
extrusion of process oil, compatibility with process equipment, etc.),
which facilitate the controlled removal of process oil in both lead-
acid and lithium separator production processes. The company also
detailed that there is no other chemical alternative that is suitable
or available to replace TCE in its lead-acid or lithium separator
processes.
    A second company requested a TSCA section 6(g) exemption for the
use of TCE as a necessary solvent for the manufacture of lead-acid
battery separators and indicated that prohibiting the use of TCE would
harm the U.S. manufacturing, energy, transportation, and defense
sectors (Ref. 49). The company describes its use of TCE as specific to
the manufacture of polyethylene plate separators used by others in
commercial wet cell batteries. Their lead-acid battery separators are
made of silica, process oil, and PE resin, a unique polymer that is
extruded into a sheet form using the process oil. After the sheet is
formed, an oil-extraction process employs TCE to extract the process
oil, which reduces the oil content within the sheet to 20-25%, and,
once the solvent has removed the precise amount of oil from the lead-
acid separator, the solvent is evaporated/removed from the separator to
yield the required porosity to allow ion flow in the finished battery.
Finally, the extracted oil and 99.7% of TCE are captured and reused in
the extraction process. The company notes that its lead-acid battery
separators are essential in gasoline and electric-powered commercial
vehicles, emergency response and military vehicles, marine engines,
nuclear power providers, as well as other business sectors. The company
further reiterates the unique chemical properties that are essential to
facilitate the controlled removal of process oil while allowing the
company to recover and recycle previously-used TCE efficiently for
reuse in the battery separator production process in a manner that they
describe as minimizing worker exposure, while resulting in a product
with the characteristics required by battery producers. The company has
provided details to EPA on its sophisticated engineering process that
follows the hierarchy of controls to minimize worker exposure. This
includes a separate enclosed structure under negative pressure as a
work area for TCE processing; limiting the time personnel are allowed
to enter spaces where they could be potentially exposed to 15 minutes
at a time; work area ventilation and filtration using carbon beds; and
PPE including either a half-face or full-face air purifying respirator
for any entry into the work area, as well as chemical-resistant gloves,
chemical-resistant aprons, goggles, and face shields (Ref. 49, 53).
    Both companies that requested a time-limited exemption for use of
TCE for battery separator production in the U.S. have demonstrated to
EPA the facility-specific research, development, and implementation of
sophisticated control measures to minimize TCE exposures, while also
searching for reasonably available alternative solvents and processes
(Refs. 48, 49).
    According to the requesters, there are several properties that make
TCE uniquely suitable for use in the manufacture of battery separators.
First, TCE is non-flammable. According to one requester, the only other
solvent that is currently in use in this application is hexane, which
is explosive and highly flammable, presenting a safety risk. Other key
properties described by the requesters include TCE's rapid extraction
of process oil, its compatibility with the metallurgy of the process
equipment, the ease by which TCE is distilled from the process oil for
recovery and reuse, and its vapor pressure that both allows for
evaporation and permits condensation from the atmosphere using cooling
coils. One requester evaluated more than a dozen potential
alternatives, including hexane, other chlorinated solvents such as
methylene chloride and perchloroethylene, 1-bromopropane, acetone,
alcohols, siloxanes, and water. Some were eliminated as not being
compatible with the process, such as water, which is not miscible with
the process oil, so it cannot be used to extract the oil. Others were
found to be much less effective than TCE at extracting process oils,
while some were not as easy to recover and reuse. Even the more
promising solvents, such as perchloroethylene, were not drop-in
replacements and would, according to the requester, require expensive
equipment modifications and a multi-year customer approval process.
Based on requester submissions and EPA's general understanding of the
battery separator manufacturing process, EPA believes that there are no
feasible

alternatives to TCE available at present (Refs. 48, 49, 52).
    One company requested a fixed exemption period of 25 years due to
the critical nature of TCE use, current lack of any safer
technologically or economically feasible alternative, and to avoid
grave disruption to the U.S. economy, critical infrastructure, and
defense base (Ref. 54). The company further explained that a
restriction on TCE without sufficient time to identify, develop, and
test a technically and economically feasible alternative (should such
an alternative be identified and become available) would pose
significant cost and safety concerns for the automobile and other
critical infrastructure industries. The requester further explained
that battery manufacturer customers and end users require compliance
with strict performance testing, and, in addition, if a technically
feasible alternative does become available, it will take multiple years
to retrofit and obtain approvals required for the technical, economic
and commercial feasibility of the separators. The company offered to
provide EPA periodic reports every five years on its efforts to
identify and assess feasible alternatives; in this way, EPA would
receive ongoing alternatives analyses to ensure forward progress, while
the company would obtain the regulatory certainty needed to maintain
sustainable production for its customers (Ref. 48).
    Similarly, the second company requested a 25-year exemption from
restrictions on this use of TCE, with an additional request that EPA
consider future extensions for additional time, in order to allow its
use of TCE until a safer, feasible alternative is available (Ref. 49).
The company justified the lengthy exemption request by explaining its
ongoing search for alternatives since 2014, and its estimates that,
while it will be another five years before a suitable alternative is
identified, the period for trial use, customer vetting and approval and
construction of a new manufacturing plant is expected to last at least
20 years. In addition, the second requester also offered to submit to
EPA periodic reports every five years to detail their efforts to
identify and assess feasible alternatives.
    Based on the information provided to EPA, EPA proposes that
compliance at this time with a prohibition for this specific condition
of use would significantly disrupt national security and critical
infrastructure. EPA agrees that the use of lead-acid batteries and
lithium battery separators is crucial to each of these sectors at this
time. These batteries are essential for critical infrastructure such as
transportation and security systems, as well as for energizing the
national defense base (e.g., nuclear submarine batteries). Furthermore,
EPA agrees that compliance with the prohibition would disrupt national
security priorities of reducing supply chain risks by building a robust
domestic renewable power sector and transitioning to a clean energy-
based economy.
    Despite the request for a 25-year exemption from two separate
companies, EPA is proposing a 10-year time-limited TSCA section 6(g)
exemption. EPA believes that a 10-year exemption from the prohibition
on TCE as a processing aid, specific to lead-acid and lithium battery
separator manufacturing, is reasonable because it would be sufficient
to provide EPA with an updated analysis of any technically feasible
alternative, the supply chain of the U.S. battery industry, as well as
global innovation and production in high-technology products. Under
TSCA section 6(g), EPA can consider revisiting or extending time-
limited exemptions by rulemaking until a safer, feasible alternative
becomes available, provided EPA receives an updated analysis of the
specific use. EPA considered the emphasis in TSCA section 6(d) that
compliance dates be as soon as practicable, and that TSCA section 6(g)
requires that any exemptions be well-justified. EPA also took into
consideration the regulatory scheme under the European Chemicals Agency
for this use of TCE for battery separator manufacturing, and the
periodic reporting cycle established in the European Union and United
Kingdom. In the EU and UK, authorizations are chemical- and facility-
specific and for a duration of either 7 or 12 years. Under the current
EU and UK authorizations, in which a panel reviewed the scientific and
economic implications of the specific TCE use, each battery separator
manufacturing company was approved for a 7-year authorization period
(with a 2023 expiration date); both companies have applied for a
renewal for an additional 12 years after 2023 (Ref. 55). Noting that
this industry has been able to provide updated applications for
authorization to the EU and UK in a renewal cycle that has been shorter
than 10 years, the two companies' interest in providing periodic
updates to EPA, and the fast pace of battery technology development,
EPA proposes that 10 years is sufficient for this time-limited
exemption, and that this timeframe would also align with the EU and UK
approaches. EPA requests comment on whether 10 years is an appropriate
timeframe for the proposed TSCA section 6(g) exemption for industrial
and commercial use of TCE as a processing aid for battery separator
manufacturing (lead-acid and lithium battery separators).
ii. Analysis of the Need for a TSCA Section 6(g)(1)(B) Exemption for
TCE Use for DoD Naval Vessels
    During the analysis for this rulemaking of the use of TCE, EPA has
identified that it is necessary to allow for the continued use of TCE
for industrial uses for DoD naval vessel requirements for potting,
bonding and sealing compounds, bonding and cleaning requirements for
naval combat systems, radars, sensors, equipment, and fabrication and
prototyping processes.
    These naval vessel-related COUs cover the platform itself and/or
specific systems, equipment, or processes. The use of TCE for
industrial uses on DoD naval vessels is critical and essential, and a
prohibition for this specific condition of use would significantly
disrupt national security and critical infrastructure. An exemption for
DoD uses for naval vessels would enable the continued use of TCE for
the COUs described which relate to vessels and their systems, and which
enable maintenance, fabrication and sustainment and thus the operation
of naval vessels and equipment.
    DoD has been unable to identify suitable alternatives for TCE for