risk of injury to health driven by inhalation exposures for
occupational conditions of use. In the case of TCE, EPA has calculated
the ECEL to be 0.0011 parts per million (ppm) (0.0059 mg/m\3\) for
inhalation exposures as an 8-hour TWA in workplace settings, based on
the most sensitive acute non-cancer occupational HEC for fetal cardiac
defects (Ref. 13). The differences between the ECEL and the OSHA PEL
are discussed in more detail in Unit II.C.1.b. EPA chose the acute non-
cancer developmental toxicity endpoint for TCE as the basis for the
exposure limit for the proposed regulatory action as it is the most
sensitive endpoint and, therefore, would be protective of both acute
and chronic non-cancer as well as cancer inhalation endpoints over the
course of a working day and lifetime, including for potentially exposed
or susceptible subpopulations (additional explanation is in Unit
VI.A.). However, as discussed in Unit V.A.2., EPA expects that
detection of and adherence to extremely low-ppm levels of TCE may
present challenges to the regulated community (Ref. 45), and so EPA is
proposing the WCPP until the prohibition compliance date. EPA
emphasizes the time limited nature of this WCPP, due to the likely need
for reliance on air-supplied respirators of APF 1,000 or 10,000 that
would be needed to address the unreasonable risk, even when engineering
and administrative controls are put into place. More details are
provided later in this unit.
    iii. Dermal protection. As part of the WCPP, EPA is proposing to
require use and provision of chemically resistant gloves by potentially
exposed persons in combination with specific activity training (e.g.,
appropriate procedures for glove removal, replacement, and disposal)
for tasks where dermal exposure can be expected to occur. However, EPA
understands these tasks are expected to occur for conditions of use,
such as processing TCE as a reactant, where closed system processes are
already in place to minimize exposure to TCE. EPA is not proposing to
require owners or operators to document consideration of the hierarchy
of controls for dermal exposures to TCE because EPA intends to prohibit
all uses of TCE, EPA is proposing relatively rapid compliance dates for
the prohibitions for most uses of TCE, and dermal PPE programs are
somewhat more straightforward to implement than respiratory PPE
programs. In proposing dermal requirements, EPA took into consideration
the volatile nature of TCE because the dermal absorption of TCE depends
on the type and duration of exposure. For the conditions of use that
would be subject to the WCPP, EPA also considered the unique, closed
system processes of each use which aid to reduce dermal exposure.
    iv. WCPP considerations. EPA is proposing a WCPP for several
conditions of use of TCE to reduce the unreasonable risk to the extent
possible during the time period before a prohibition becomes effective,
described in Unit V.A.2.
    In deciding whether an ECEL and related required measures would
appropriately reduce the unreasonable risk driven by occupational
inhalation exposures, EPA considered factors related to work activities
that may make it difficult to comply with an ECEL, particularly at the
low air concentration level EPA has identified. Once EPA identified the
appropriate risk-based inhalation limit to reduce identified
unreasonable risk, EPA carefully considered the appropriateness of such
an exposure control program for each occupational condition of use of
TCE, in the context of the unreasonable risk. Examples include
conditions of use with work activities that may take place in the
field, making it challenging to establish a regulated area and conduct
monitoring; work activities that may take place in open systems that
require manual contact with the chemical substance; work activities
that may take place in small, enclosed spaces, creating challenges for
implementing engineering controls or using respiratory PPE; work
activities that require a high range of motion or for some other reason
create challenges for the implementation of respiratory PPE; and the
type of PPE that would be needed under the TCE WCPP to meet the ECEL in
the absence of, or in addition to, other feasible exposure controls,
based on analysis in the 2020 Risk Evaluation for TCE describing
expected exposures with and without use of PPE.
    EPA also considered the feasibility of exposure reduction
sufficient to reduce the unreasonable risk, including in facilities
currently complying with the OSHA PEL for TCE or implementing other
recommended OELs such as the ACGIH TLV. While EPA acknowledges the
regulated community's expected familiarity with OSHA PELs generally, as
well as facilities' past and ongoing actions to implement the TCE PEL,
the value of EPA's exposure limit is almost five orders of magnitude
lower than the OSHA PEL. (The differences between the ECEL and the OSHA
PEL are discussed in more detail in Unit II.C.4.) This creates a
significant degree of uncertainty as to whether facilities engaging in
most conditions of use could implement engineering or administrative
controls to reduce exposures in a manner aligned with the hierarchy of
controls to meet the ECEL (and associated action level) and whether
they could do so without relying primarily on the use of PPE (which is
the least preferred option in the hierarchy of controls) to supplement
exposure reduction efforts.
    EPA understands that this uncertainty extends to the feasibility of
respirators as a long-term risk management practice as well, since the
complexity and burden of wearing respirators increases with increasing
APF. Although respirators, specifically SCBAs (APF 10,000), could
reduce exposures to levels that protect against non-cancer and cancer
risks, not all workers may be able to wear respirators. Individuals
with impaired lung function due to asthma, emphysema, or chronic
obstructive pulmonary disease, for

example, may be physically unable to wear a respirator. OSHA requires
that a determination regarding the ability to use a respirator be made
by a physician or other licensed health-care professional, and annual
fit testing is required for tight-fitting, full-face piece respirators
to provide the required protection. Individuals with facial hair, such
as beards or sideburns that interfere with a proper face-to-respirator
seal, cannot wear tight fitting respirators. In addition, respirators
may also present communication problems, vision problems, worker
fatigue, and reduced work efficiency (63 FR 1152, January 8, 1998).
According to OSHA, ``improperly selected respirators may afford no
protection at all (for example, use of a dust mask against airborne
vapors), may be so uncomfortable as to be intolerable to the wearer, or
may hinder vision, communication, hearing, or movement and thus pose a
risk to the wearer's safety or health.'' (63 FR 1189 through 1190).
Furthermore, depending on the air concentrations and proximity to the
regulated area, other employees in the area may also need to wear
respiratory PPE. EPA understands, based on reasonably available
information, that occupational exposures tend to fluctuate depending on
the task being performed and the frequency of the task, which could
create challenges for reliably effective implementation of respiratory
PPE (Refs. 70, 72, 35).
    EPA reviewed reasonably available information, including monitoring
data, and information related to considerations described previously in
this unit. EPA expects attempts to implement the WCPP to include
increased monitoring and that industry would likely need to exclusively
rely on PPE when aiming to reach the ECEL, including the use of high
APF respirators, such as fit-tested, air-supplied respirators of APF
1,000 or APF 10,000. Given the high APF of respirators that are likely
needed to reach the ECEL, EPA recognizes that this equipment and its
programmatic maintenance could be highly burdensome. EPA believes this
could create implementation challenges and is not a long-term,
sustainable use of the WCPP. The WCPP would be in place for a
relatively short period of time (less than 10 years for the vast
majority of production value) until the eventual prohibition, because
of the likely need for such extensive PPE. The ultimate goal for TCE is
prohibition given the difficulty of maintaining a WCPP long term.
    One of the conditions of use for which EPA is proposing a WCPP
until the prohibition goes into effect is processing TCE as a reactant/
intermediate. The majority of the annual production volume of TCE
processed as an intermediate under this condition of use goes almost
entirely toward the manufacture of one HFC, HFC-134a (Refs. 3, 70, 73).
Monitoring information submitted by facilities processing TCE as an
intermediate to manufacture HFC-134a suggests that TCE is largely
confined to the process reactors, which require infrequent loading and
unloading activities taking place approximately 20 times per year and
resulting in low-ppm TCE exposure levels (Ref. 70). The information
submitted also highlights that TCE is consumed and transformed during
the reaction process (Ref. 70). Additionally, HFC-134a is one of the
regulated substances that are subject to a phasedown under the AIM Act,
and as discussed in Unit I.D., EPA understands that HFC-134a has a
lower GWP compared to other refrigerants, which will likely continue to
be used to facilitate the transition from certain other HFCs pursuant
to the phasedown under the AIM Act. Providing a longer phaseout under
TSCA for processing TCE as an intermediate for the manufacture of HFC-
134a, while subject to a WCPP, is consistent with the agency's efforts
to address climate-damaging HFCs, such as HFC-134a, under the AIM Act.
EPA is seeking comment on the actions that manufacturers who process
TCE for the production of HFC-134a would take as a result of this
proposed phaseout and whether this would motivate a decision to cease
manufacture earlier than they would otherwise under the AIM Act phase-
down. For the remaining volume of TCE processed as a reactant/
intermediate for chemical synthesis other than manufacturing HFC-134a,
additional time may be necessary to reconfigure or otherwise adjust the
physical plant to accommodate an alternative manufacturing process, so
a WCPP is also associated with the prohibition of other processing as a
reactant/intermediate uses; however, the phaseout does not apply to the
other uses for which EPA is proposing a more immediate prohibition
discussed in Unit V.A.
    Additionally, EPA considered other industrial and commercial uses
as candidates for a WCPP. Similar to the processing of TCE as a
reactant/intermediate, unique, closed-system processes exist for the
industrial and commercial use as: processing aid in process solvent
used in battery manufacture; a process solvent used in polymer fiber
spinning, fluoroelastomer manufacture and Alcantara manufacture; an
extraction solvent used in caprolactam manufacture; and a precipitant
used in beta-cyclodextrin manufacture. Where TCE is used as a
processing aid, TCE is consumed or captured and reused in the process.
Monitoring data suggests low-ppm TCE exposure levels but may involve
daily worker tasks. EPA understands that some of the industrial and
commercial uses of TCE as a processing aid occur outside of the U.S.,
or may no longer be ongoing in the U.S. However, EPA received and
reviewed substantive information from the battery separator
manufacturing industry, specifically for lead-acid and lithium-ion
battery separator manufacturing processes, along with a request for a
TSCA section 6(g) exemption under this TSCA rulemaking. EPA agrees that
battery separator manufacturing is critical to the national economy and
national security; therefore, EPA is proposing to grant a 10-year
exemption from the prohibition for the industrial and commercial use of
TCE as a processing aid for battery separator manufacturing. For this
exemption EPA is proposing to impose the WCPP requirements as a
condition for the TSCA section 6(g) exemption. All other industrial and
commercial processing aid uses (e.g., process solvent used in polymer
fabric spinning, fluoroelastomer manufacture, etc.) must comply with
the more stringent prohibition detailed in Unit V.A.
    Furthermore, EPA considered industrial and commercial uses of TCE
as an essential laboratory chemical as necessary to continue following
the WCPP requirements, during the period of the TSCA section 6(g) time-
limited exemption described in Unit V.A. Industrial and commercial use
as a laboratory chemical is necessary to provide for the analysis of
monitoring samples required to implement the ECEL requirements under
the WCPP as part of this proposed regulation, as well as for essential
chemical analysis, including for ongoing cleanup projects that fall
under the Superfund program or other EPA jurisdictions, described in
Unit V.A.3. Furthermore, EPA expects laboratory settings to be more
conducive to the implementation of engineering controls such as fume
hoods to ventilate vapors and reduce overall exposure to TCE in
alignment with the hierarchy of controls.
    Lastly, for TCE to be available for the downstream uses described
in this unit, it must be manufactured (including imported), processed,
and distributed in commerce. Therefore, as discussed in Unit V.A., EPA
is proposing the WCPP

for manufacturing (including importing) and processing for certain
industrial and commercial uses, to allow a continuous supply chain for
the specified conditions of use expected to continue 1 year after the
final rule is published until the prohibition compliance dates.
2. Primary Alternative Regulatory Action
    EPA acknowledges that, for some conditions of use that it is
proposing to prohibit, there may be some activities or facilities that
need longer compliance timeframes in order to appropriately transition.
Therefore, the primary alternative regulatory action accounts for
additional time under a prohibition to provide the flexibility for
facilities to comply, for example, to account for issues in the supply
chain, such as the availability of alternatives to reformulate
products. In selecting among the TSCA section 6(a) requirements for the
primary alternative regulatory action for use of TCE-containing
products, EPA considered risk-related factors, including but not
limited to, the population exposed and the severity of the hazard of
TCE and, separately, of other alternative solvents, which are
undergoing risk evaluation and risk management under TSCA section 6,
such as PCE (as part of a separate rulemaking under RIN 2070-AK84). For
example, there may be instances where PCE and TCE may be desired
because they are non-flammable solvents used as cleaning agents for
energized electrical equipment (e.g., circuit boards). In these
instances, additional time may be needed to identify an alternative
chemical or process to avoid flammability concerns.
    EPA also considered a TSCA section 6(g) time-limited exemption for
additional conditions of use that are critical or essential, or where a
prohibition could have significant impacts on the national economy,
national security, and infrastructure As described in Unit V.B.3.a.ii.,
EPA requests comments on a TSCA section 6(g) exemption, and based on
the information received may find that an exemption may be warranted
under the primary alternative regulatory action for the industrial and
commercial use of TCE in batch vapor degreasing for critical aerospace
or medical device applications, if the workplaces engaged in that
condition of use cannot meet the requirements of the proposed
regulatory action.
    Similar to the proposed regulatory action, the primary alternative
regulatory action would include a WCPP for several conditions of use of
TCE to reduce to the extent possible the unreasonable risk during the
time period before a prohibition becomes effective, including as a
condition to the TSCA section 6(g) exemption, per TSCA section 6(g)(4).
For the implementation of the TCE WCPP, EPA considered providing
additional time under the primary alternative regulatory action for the
WCPP requirements given the difference in order of magnitude for the
exposure limit under TSCA compared to levels required by OSHA or other
recommended guidelines. These provisions would include, for instance,
identifying appropriate monitoring methods to comply with an TSCA
exposure limit that is five orders of magnitude lower than the OSHA PEL
(i.e., 0.0040 ppm vs. 100 ppm, respectively), as well as providing for
respiratory protection corresponding to a higher assigned protection
factor than required by OSHA, further described in Unit II.C.
    Further, the WCPP under the primary alternative regulatory action
would include an ECEL of 0.0040 ppm to address inhalation exposures to
TCE in occupational settings that is based on the immunotoxicity
endpoint. EPA believes that this ECEL would be less protective than the
ECEL of 0.0011 ppm based on the developmental toxicity endpoint, that
EPA would require under the proposed regulatory action. (A summary of
EPA's risk evaluation activities under TSCA is provided in Unit II.D.,
and the health effects of TCE, including the difference in the two
human health endpoints as the basis for the two different ECELs, are
discussed in Unit VI.A.) EPA considered the extremely low-ppm values of
both ECELs and acknowledges the uncertainties regarding the ability of
traditional industrial hygiene methods to meet the limit of detection
associated with either ECEL action level, and the feasibility of
combining existing engineering and administrative controls to reduce
the exposure of TCE to extremely low-ppm levels before relying on PPE.
Therefore, EPA does not consider long-term implementation of the WCPP a
feasible means of addressing unreasonable risk indefinitely; as such,
prohibition of the affected conditions of use is ultimately necessary
to address the unreasonable risk under both the proposed and primary
alternative regulatory actions.
    The primary alternative regulatory action is described in more
detail in Unit V.B.
3. Risk Management Requirements Considered But Not Proposed
    EPA considered but is not proposing to regulate the weight fraction
of TCE in products for industrial and commercial or consumer use
because TCE is the main constituent (e.g., cleaning component) of the
majority of TCE-containing product formulations and EPA understands
that decreasing the concentration of TCE decreases the efficacy of the
product (Refs. 74, 75).
    EPA also examined the extent to which a self-certification and
limited-access program restricting TCE use to trained and licensed
users could ensure that only certain workers employed by a facility
would be able to purchase and subsequently use TCE. Under a limited
access program such as a point-of-sale self-certification, entities
would submit a self-certification to the distributor at the point of
purchasing the products. The self-certification could consist of a
statement indicating that the facility is implementing the required
workplace safety measures to control exposures to TCE. However, a
point-of-sale self-certification is not a viable option for this
proposed rulemaking. Given the eventual full prohibition of TCE and the
significant investments users may have to make toward establishing a
WCPP, EPA does not believe it would be practicable to add an additional
burden of implementing a limited access program. Therefore, EPA is not
proposing a self-certification and limited access program as part of
this rulemaking. EPA requests comment on the effectiveness of a limited
access program, such as a point-of-sale self-certification or other
administrative controls, to address the unreasonable risk of TCE, in
particular for facilities with occupational exposures to TCE that may
not be able to meet the WCPP requirements of this proposed rulemaking.
    Another option that EPA considered was requiring prescribed
engineering controls, administrative controls, or personal protective
equipment to reduce exposures to TCE in occupational settings.
Prescriptive requirements would be supported by information in the 2020
Risk Evaluation for TCE. However, as described in Unit III.A.1. and 2.,
EPA received input during required consultations and additional
stakeholder engagement that regulatory options that align with the
hierarchy of controls (i.e., elimination and substitution of hazards in
the workplace) should be preferred over prescriptive controls (which
alternatively could be accomplished through the implementation of a
WCPP with a risk-based exposure limit) (Refs. 12, 31). Inadequacy of
engineering, administrative, and personal protective equipment control
measures to lower exposure below the exposure limit

would mean that elimination or substitution would be the only viable
methods of addressing unreasonable risk. Additionally, the WCPP
approach EPA is considering under the proposed action is a more
flexible approach as prescriptive controls present significant
uncertainties related to their feasibility, given the site-specific
operations and variable configurations, and need for consistency of
proper use.
    EPA determined that such controls (i.e., engineering or
administrative controls, or PPE) may not be able to eliminate
unreasonable risk for some conditions of use when used in isolation. In
the 2020 Risk Evaluation for TCE, many conditions of use still drive
unreasonable risk even with the application of air-supplied APF 50
respirators (Ref. 1). Reasonably available data indicated additional
uncertainty regarding the feasibility of exposure reductions through
engineering controls alone, considering the unique closed-system
processes already in place (Refs. 70, 48). For occupational conditions
of use, prohibitions (rather than prescribed controls) would be more
appropriate to ensure the elimination of unreasonable risk of TCE.
Nevertheless, EPA determined that a WCPP, including requirements for an
ECEL (which would be accompanied by monitoring requirements) in tandem
with the implementation of engineering controls, administrative
controls, and/or PPE, as appropriate, would be necessary for reducing
exposures to TCE prior to the proposed prohibition compliance dates.
4. Additional Considerations
    After considering the different regulatory options under TSCA
section 6(a), alternatives (described in Unit V.B.), compliance dates,
and other requirements under TSCA section 6(c), EPA developed the
proposed regulatory action described in Unit V.A. to address the
unreasonable risk from TCE so that it is no longer unreasonable. To
ensure successful implementation of this proposed regulatory action,
EPA considered other requirements to support compliance with the
proposed regulations, such as requiring monitoring and recordkeeping to
demonstrate compliance with a WCPP and downstream notification
regarding the prohibition on manufacturing (including import),
processing, and distribution in commerce of TCE, and products
containing TCE, for industrial and commercial use as well as consumer
uses. These proposed requirements are described in Unit V.A.
    As required under TSCA section 6(d), any rule under TSCA section
6(a) must specify mandatory compliance dates, which shall be as soon as
practicable with a reasonable transition period, but no later than 5
years after the date of promulgation of the rule (except in the case of
a use exempted under TSCA section 6(g) or for full implementation of
ban or phaseout requirements). These compliance dates are detailed in
Units V.A. and V.B. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.

B. Consideration of Alternatives in Deciding Whether To Prohibit or
Substantially Restrict TCE

    Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or
restrict in a manner that substantially prevents a specific condition
of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must consider, to
the extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other
restriction takes effect. To that end, in addition to an Economic
Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using
reasonably available information (Ref. 71).
    For this assessment, EPA identified and analyzed alternatives to
TCE in products relevant to industrial, commercial, and consumer
conditions of use proposed to be prohibited or restricted. Based on
reasonably available information, including information submitted by
industry, EPA understands viable alternatives to TCE may not be
available for several conditions of use, for example, processing TCE as
an intermediate for the manufacture of HFC-134a, and considered that
information to the extent practicable in the development of the
regulatory options as described in Unit III.B.3. For some conditions of
use, EPA was unable to identify products currently available for sale
that contain TCE. EPA is soliciting comments on whether there are
products in use or available for sale relevant to these conditions of
use that contain TCE at this time, so that EPA can ascertain whether
there are alternatives that benefit human health or the environment as
compared to such use of TCE. These conditions of use are detailed in
the Alternatives Assessment (Ref. 71).
    For conditions of use for which products currently containing TCE
were identified, EPA identified several hundred commercially available
alternative products that do not contain TCE, and listed in the
Alternatives Assessment, to the extent practicable, their unique
chemical components, or ingredients. For each of these chemical
components or ingredients, EPA identified whether it functionally
replaced TCE for the product use and screened product ingredients for
human health and environmental hazard, as well as identified
flammability and global warming potential where information was
reasonably available (Ref. 71). EPA then assigned a rating to the human
health and environmental hazards, using a methodology described in the
Alternatives Assessment document. In general, EPA identified products
containing ingredients with a lower hazard screening rating than TCE
for certain endpoints, while some ingredients presented higher hazard
screening ratings than TCE (Ref. 71). These alternative hazard
screening ratings are described in detail in the Alternatives
Assessment grouped under common product use categories (Ref. 71).
    Discussion of alternatives to TCE was discussed during the SBAR
Panel process outreach meetings. EPA's consideration of alternatives
was informed by the information provided by SERs, which included known
problems and risks with several available alternatives, such as
flammability, toxicity, and water limitations due to drought.
Specifically, SERs discussed how some chlorinated solvents are
currently undergoing TSCA risk evaluations, while other alternatives
may be labeled as severe fire hazards by the National Fire Protection
Association. SERs also mentioned that in the automotive and aerospace
industries, alternative solvent degreasers may have their own hazard
profile, which can include flammability, lower boiling temperatures,
and toxicity (Ref. 32). SERs expressed concern for future regulation of
chemicals undergoing risk evaluation, and also described the challenges
of alternative processes, such as aqueous methods. Specifically, SERs
described how in certain regions it is difficult to justify
installation of these systems due to limited space or water
availability. One SER provided an account about one of their customers,
who had an aqueous cleaning system installed and was unable to source
the required amount of water to run it. EPA notes the concerns
expressed by SERs regarding availability of feasible alternatives that
could be subject to market forces that may impact availability of
alternatives (e.g., certain fluorinated chemicals) or potentially be

subject to future EPA regulations. EPA notes that SERs described how
available alternatives for lubricants in spray applications are mostly
fluorinated organic compounds; although non-fluorinated options may
exist, the SERs expressed concern for future potential regulatory
activity. A trade organization SER highlighted that some fluorinated
alternatives to TCE are under increased regulatory scrutiny, especially
at state levels, because they may be subject to state PFAS laws based
on their chemical structure and properties (Ref. 32). These discussions
with SERs informed the Panel recommendations.
    EPA has considered input from SERs and other stakeholders regarding
alternatives to TCE, as well as the information used for the
Alternatives Assessment. In deciding whether to propose prohibition or
other significant restrictions on a condition of use of TCE and in
proposing an appropriate transition period for any such action, EPA has
therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the
extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use proposed to be prohibited or restricted, would be reasonably
available as a substitute when a proposed prohibition or other
significant restriction would become effective. EPA is additionally
requesting comment on the Alternatives Assessment as a whole.

VII. TSCA Section 6(c)(2) Considerations: Magnitude of Human Exposure,
Environmental Effects of TCE, Benefits of TCE for Various Uses, and
Reasonably Ascertainable Economic Consequences

    As described in Unit IV., 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. EPA's
consideration of the health effects of TCE is in Unit IV.; EPA's
consideration of the remaining considerations under TSCA section
6(c)(2) are in this unit.

A. Magnitude of Human Exposure to TCE

    TSCA section 6(c)(2)(B) directs EPA to factor in, to the extent
practicable, the magnitude of human exposure to TCE under TSCA section
6(c)(2)(A). EPA's analysis of the magnitude of human exposure to TCE
are in the 2020 Risk Evaluation for TCE (Ref. 1). A summary is
presented here.
    Regarding the magnitude of human exposure, one factor EPA considers
for the conditions of use that drive unreasonable risk is the size of
the exposed population which, for TCE, EPA estimates is 43,675 workers,
8,920 ONUs, and 20,600 consumers (Ref. 3).
    For the conditions of use that drive the unreasonable risk for TCE,
PESS include workers and occupational non-users (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.
    In addition to workers, ONUs, consumers, and bystanders to consumer
use directly exposed to TCE, EPA recognizes there is exposure to the
general population from air and water pathways for TCE. As mentioned in
Unit II.D., EPA has separately conducted a screening approach to assess
whether there may be potential risks to the general population from
these exposure pathways. The screening approach was developed in order
to allow EPA to determine--with confidence--situations which present no
unreasonable risk to fenceline communities or where further
investigation would be needed to develop a more-refined estimate of
risk. The fenceline technical support memos for the ambient air pathway
and the water pathway provide the Agency with a quantitative assessment
of exposure. For TCE, the results from applying this screening approach
did not allow EPA to rule out unreasonable risk to fenceline
communities. This unit summarizes the results of that fenceline
analysis. Although EPA is not making a determination of unreasonable
risk based on the fenceline screening analysis, the proposed regulatory
action described in Unit V.--which would ultimately prohibit all
conditions of use of TCE is expected to eliminate the risks identified
in the screening approach.
    As described in Unit II.D., EPA's analysis methodology was
presented to the SACC peer review panel in March 2022, and EPA
considered SACC feedback (including the SACC recommendation to EPA to
consider multiple years of release data to estimate exposures and
associated risks) when applying the fenceline analysis to TCE. EPA also
plans to consider SACC feedback and make decisions regarding how to
build upon the screening approach so that EPA can more accurately
assess and quantify general population exposures in upcoming risk
evaluations, such as for the 1,4-dioxane supplement, the forthcoming 20
High Priority Substances, and manufacturer-requested risk evaluations.
For TCE, EPA is including a multi-year assessment of the ambient air
pathway in light of peer review comments on the initial methodology.
    EPA interpreted risk estimates in relation to the benchmark values
corresponding to each hazard value. In the case of acute and chronic
exposures to drinking water, as well as incidental oral and incidental
dermal exposures in ambient waters, potential for noncancer risk was
identified by those risk estimates below the benchmark MOE for acute
and chronic non-cancer immunotoxicity and developmental endpoints.
While cancer risks were not assessed for incidental oral or dermal
exposure pathways, cancer risks were assessed for inhalation exposures.
For cancer, potential for risk was identified by those risk estimates
above the benchmark. For the air pathway, EPA's analysis identified
risk estimates that did not exceed the benchmarks for at least two non-
cancer endpoints (developmental and immunotoxicity), and risk estimates
above the benchmark for cancer. Estimates of cancer risk to fenceline
communities were calculated and compared to 1 x 10-6 as a
benchmark value for cancer risk in fenceline communities. Cancer
benchmarks used by EPA and other regulatory agencies in interpreting
the significance of cancer risks range from 1 in 1,000,000 to 1 in
10,000 (i.e., 1 x 10-6 to 1 x 10-4) depending on
the subpopulation exposed (see, e.g., EPA's interpretation set forth in
the Federal Register of September 14, 1989 (54 FR 38044) which
discusses the use of benchmarks for purposes of assessing exposures to
individuals living in the vicinity of air emissions sources under
section 112 of the Clean Air Act (CAA); see also EPA's interpretation
of the upper bound of acceptable risk and the preferred benchmark
described in the Letter of Concern regarding EPA Complaint Nos. 01R-22-
R6, 02R-22-R6, and 04R-22-R6 (Ref. 76, see page 3

footnotes 5 and 6, and page 6)). While EPA is unable to formally
determine, based on the screening level fenceline analysis, whether
risks to the general population drive the unreasonable risk, as a
matter of risk management policy EPA considers the range of 1 in
1,000,000 to 1 in 10,000 (i.e., 1 x 10-6 to 1 x
10-4) as the appropriate values for interpreting the
significance of increased cancer risk for the general population,
including fenceline communities. It is preferable to have the air or
water concentrations of TCE result in an increased cancer risk closer
to the 1 in 1,000,000 (1 x 10-6) value, with the 1 in 10,000
(1 x 10-4) value generally representing the upper bound of
acceptability for estimated excess cancer risk. Benchmark values help
inform decisions regarding the significance of risk, and the Agency
considers a number of other factors when determining whether risks are
significant, such as the endpoint under consideration, the
reversibility of effect, and exposure-related considerations (e.g.,
duration, magnitude, or frequency of exposure, or population exposed).
    In this unit, EPA presents the results of its ambient air and water
pathways fenceline analysis and the uncertainties associated with the
analysis. Overall, EPA's fenceline analysis for the air and water
pathways for TCE did not allow EPA to rule out unreasonable risk to
fenceline communities with confidence. Additionally, based on the
fenceline analysis for the ambient air and water pathways for TCE,
including the strengths, limitations, and uncertainties associated with
the information used to inform the analysis, EPA is unable to determine
with this analysis whether those risks drive the unreasonable risk of
injury to health presented by TCE. EPA also describes how the proposal
to prohibit the manufacturing (include importing), processing, and
distribution in commerce of TCE for all uses of TCE (including all
consumer use) is expected to eliminate the potential risks identified
in the screening analysis to any general population or fenceline
communities close to facilities engaging in TCE use. This unit also
describes how EPA believes the proposed WCPP requirements may reduce
exposures to the general population for facilities identified in the
fenceline analysis with expected exposures to fenceline communities
that are associated with conditions of use for which EPA is proposing
longer compliance timeframes (including under a TSCA section 6(g) time-
limited exemption). EPA therefore does not intend to revisit the air or
water pathways for TCE as part of a supplemental risk evaluation.
1. Ambient Air Pathway Analysis
    The ambient air fenceline analysis was divided into three
components: (1) A single-year ambient air analysis, (2) A multi-year
ambient air analysis, and (3) A land use analysis. EPA conducted an
ambient air analysis for a single year and multiple years to assess
where estimates exceeded the one in a million risk estimates for non-
cancer and cancer risk for real and generic, or modeled, facilities at
multiple distances. After doing an initial screen (the single year
ambient air screening analysis) that did not rule out unreasonable
risk, EPA conducted additional analyses (the multi-year ambient air
analysis) from which it derived risk estimates that, with a small
number of exceptions, are within the cancer benchmarks used by EPA and
other regulatory agencies of 1 in 10,000 to 1 in 1,000,000. The single
year ambient air screening analysis and the multi-year ambient air
analysis allow EPA to mathematically calculate a cancer risk in
fenceline communities. The Agency then conducted a land use analysis as
part of both the single-year and multi-year analyses to determine if
EPA could reasonably expect an exposure to fenceline communities to
occur within the modeled distances for facilities where there was an
indication of risk. This review consisted of a visual analysis using
aerial imagery and interpreting land/use zoning practices around each
facility to identify where residential, industrial/commercial
businesses, or other public spaces are present within those radial
distances indicating risk (as opposed to uninhabited areas), as well as
whether the radial distances lie outside the boundaries of the
facility.
    There are some uncertainties associated with the fenceline analysis
for the air pathway for TCE. The TRI dataset used for the single- and
the multi-year fenceline analysis and land use analysis does not
include actual release point locations, which can affect the estimated
concentrations at varying distances modeled. To identify the release
location for each facility, EPA used a local-coordinate system based on
latitude/longitude coordinates reported in TRI. The latitude/longitude
coordinates may represent the mailing address location of the office
building associated with a very large facility or some other area of
the facility rather than the actual release location (e.g., a specific
process stack). This discrepancy between the coordinates reported in
TRI and the actual release point could result in an exposure
concentration that does not represent the actual distance where
fenceline communities may be exposed. The fenceline analysis also
evaluated the most ``conservative exposure scenario'' that consists of
a facility that operates year-round (365 days per year, 24 hours per
day, 7 days per week) in a South Coastal meteorologic region and a
rural topography setting (Ref. 77). Therefore, the modeled exposures to
people who live in fenceline communities may be overestimated if there
are fewer exposure days per year or hours per day.
    Additionally, the ambient air fenceline analysis (as well as the
water pathway analysis, described in Unit VII.A.2.) organizes
facilities and associated risks by OES and generally crosswalks each
OES with the associated condition of use of TCE (Ref. 77). For some
OES, EPA identified the associated conditions of use to the category
level in the November 2020 Risk Evaluation for TCE, but, for the air
pathway, was unable to identify the conditions of use to the
subcategory level due to limited information on activities and use of
TCE reported under TRI. Therefore, some OES indicating increased risk
from ambient air exposures to TCE in the air fenceline analysis may be
associated with one or more conditions of use of TCE.
    EPA's analysis included inhalation hazard values for cancer and
non-cancer risk (acute and chronic immunological and developmental
endpoints). Because risk estimates did not exceed the benchmarks for
any risks of non-cancer effects, the results presented focus on cancer
risks. EPA's single year fenceline analysis for the ambient air
pathway, based on methods presented to the SACC, evaluated TCE releases
reported to TRI over the 2019 reporting year. This single-year
fenceline analysis identified risk estimates exceeding one in a million
for cancer risk for 99 of the 133 facilities (including generic, or
modeled, facilities) at multiple distances, representing 13 OES. While
the analysis identified facilities with some indication of releases and
potential exposure with associated increased cancer risk that exceeds
one in a million at a distance of 100 meters or more from the releasing
facility, the analysis did not identify any facilities exceeding 1 in
10,000; the highest risk estimate is in the 1 in 100,000 range.
Separately, following SACC feedback, EPA applied a slightly modified
pre-screening methodology to evaluate 6 years of TCE release data (2015
through 2020 TRI data as well as the 6-year average of that data)
rather than a single year of data for facilities with reported releases
in TRI. Although the multi-year analysis

identified several additional facilities with risk estimates above one
in a million for cancer farther out when compared to the single year
analysis or that were not captured in the single-year analysis, the
results of the overall risk profiles (i.e., OES and corresponding
conditions of use with risk estimates above one in a million for cancer
at the distances evaluated) indicated a higher risk profile than the
single year analysis: the multi-year analysis identified 217 facilities
and found risk estimates above one in a million for cancer in 133 of
those facilities at a distance of 100 meters from the releasing
facility. Based on the multi-year analysis, 58 of these 133 facilities
either had risks above one in a million for cancer at distances farther
out than 100 meters when compared to the single year analysis or are
facilities that were not captured in the single-year analysis (e.g.,
did not report in 2019 TRI). The analysis did not identify any
facilities exceeding 1 in 10,000 at a distance greater than 100 meters;
the highest risk estimate is in the 1 in 100,000 range (Ref. 77).
    EPA conducted a land use analysis to determine if EPA can
reasonably expect an exposure to fenceline communities to occur within
the modeled distances for facilities where there was an indication of
risk in the single year or multi-year fenceline analysis. This review
consisted of a visual analysis using aerial imagery and interpreting
land/use zoning practices around the facility to identify where
residential, industrial/commercial businesses, or other public spaces
are present within those radial distances indicating risk (as opposed
to uninhabited areas), as well as whether the radial distances lie
outside the boundaries of the facility. The land use analysis of the 85
facilities with risk indicating risk in the single-year fenceline
analysis identified 69 facilities with expected exposure to fenceline
communities. The land use analysis of the 58 facilities indicating risk
in the multi-year fenceline analysis (i.e., facilities where risk
estimates were above one in a million for cancer at distances farther
out when compared to the single-year analysis or facilities that were
not captured in the single year analysis) identified a total of 55
facilities with expected exposure to fenceline communities. Those
facilities represent 10 OES and include: degreasing (batch open-top
degreasing; batch closed-loop degreasing; conveyorized vapor
degreasing; web vapor degreasing; cold cleaning); formulation of
aerosol and non-aerosol products; industrial processing aid;
manufacturing; metalworking fluids; other industrial uses; process
solvent recycling and worker handling of wastes; processing as a
reactant; recycling and disposal; and repackaging (Ref. 77).
    Under the proposed regulatory action described in Unit V.A., each
of the conditions of use that indicate risk relative to the one in a
million cancer risk estimate would ultimately be prohibited, many of
them within one year. As a result, exposures to any fenceline
communities from these facilities would be eliminated under the
prohibitions in this proposed rulemaking. The risks to fenceline
communities from exposure further strengthens the impetus for EPA's
prohibition of TCE.
    EPA recognizes that there are some facilities for which risks are
indicated that may exceed the one in a million risk estimate and with
expected exposure to fenceline communities that may be associated with
the following conditions of use that EPA is proposing to prohibit under
longer compliance timeframes: degreasing (batch open-top degreasing;
batch closed-loop degreasing; conveyorized vapor degreasing; web vapor
degreasing; cold cleaning); industrial processing aid; manufacturing;
and processing as a reactant. For processing as a reactant, EPA notes
that while the analysis identified facilities with some indication of
releases and potential exposure with associated increased cancer risk
that exceeds one in a million at a distance of 100 meters from the
releasing facility, the analysis did not identify any facilities
exceeding 1 in 10,000; the highest risk estimate is in the 1 in 100,000
range. For this and other conditions of use that may be associated with
facilities that indicate risks with expected exposure to fenceline
communities, the proposed rule would require strict workplace exposure
controls via implementation of a WCPP as described in Unit V.A.2.,
until the prohibition compliance date. Under the proposed WCPP
requirements, facilities would need to monitor indoor TCE air
concentrations, which would allow facilities to better understand and
manage the total releases of TCE. Furthermore, under the WCPP
requirements, facilities would need to evaluate controls to determine
how to reduce releases and exposures to potentially exposed persons in
the workplace. EPA anticipates that this analysis would help facilities
to determine the most effective ways to reduce exposures (including
possible engineering controls or elimination/substitution of TCE) and
whether those methods for exposure reduction impact releases, and
therefore may reduce the overall risk to fenceline communities from
facilities permitted to use TCE under a longer compliance timeframe
until the prohibition compliance date. As further detailed in Unit
V.A.2.b.iii., EPA is also 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. EPA is also
soliciting comment on the frequency and nature of air monitoring EPA
should consider including as requirements in the final rule.
    In the instances where efforts to reduce exposures in the workplace
to levels below the ECEL could lead to adoption of engineering controls
that ventilate more TCE outside, EPA believes this potential exposure
would be limited as a result of the existing NESHAP for TCE for these
conditions of use under the CAA. Applicable NESHAP include: 40 CFR part
63, subpart F, Synthetic Organic Chemical Manufacturing Industry; 40
CFR part 63, subpart DD, Off-Site Waste and Recovery Operations; 40 CFR
part 63, subpart VVV, Publicly Owned Treatment Works; 40 CFR part 63,
subpart VVVVVV, Chemical Manufacturing Area Sources; 40 CFR part 63,
subpart GG, Aerospace Manufacturing and Rework Facilities; 40 CFR part
63, subpart T, Halogenated Solvent Cleaning, which impose emission
standards and work practice requirements reflecting maximum achievable
control technology and generally available control technology. The CAA
required residual risk reviews for standards reflecting maximum
achievable control technology, and technology reviews are required
every 8 years for all NESHAP.
2. Water Pathway Analysis
    The methods used to assess the water pathways (i.e., drinking water
or incidental dermal or oral exposure in ambient waters) for TCE are
consistent

with the methods described in the 2022 Fenceline report that underwent
peer review (Ref. 78). Briefly, EPA assessed exposure via drinking
water, incidental oral ingestion, and incidental dermal contact based
on modeled stream and water body concentrations, using information
described and documented in the November 2020 TCE Risk Evaluation (Ref.
1). This included the amount of chemical released to wastewater, the
release days per year (with a high end of 250 to 365 days per year, and
a low end of 20 days per year), the percent removal from wastewater
treatment, and site-specific stream flow or dilution factors.
    There are some uncertainties associated with the fenceline analysis
for the water pathway for TCE. For the ambient water pathway, exposures
were evaluated based on modeled stream and water body concentrations
using E-FAST 2014, which is subject to a number of uncertainties. For
example, stream flow data available in the E-FAST 2014 at the time of
this analysis were 15 to 30 years old and therefore may not represent
current conditions at a particular location. Additionally, E-FAST 2014
estimates waterbody surface water concentrations at the point of
release without considering certain post-release environmental fate of
degradation processes, which may lead to higher predicted surface water
concentrations. Similarly, estimated drinking water exposures are based
on assumptions that an individual is exposed to potential waterbody
concentrations at the point of release without any potential for
transport, dilution, or treatment and therefore represent higher-end
estimates of possible drinking water exposures (Ref. 79). An additional
uncertainty relates to the crosswalk of a given facility to a
particular OES and then condition of use; as described in Unit
VII.A.2., due to limited information on activities and use of TCE in
the data sources available, there is uncertainty if the facilities
associated with a specific OES were correctly cross-walked to the
appropriate condition of use, or whether some OESs indicating increased
risk from water exposures to TCE should be associated with more than
one condition of use.
    EPA's screening level analysis for the water pathway for TCE, based
on methods presented to the SACC, found potential risks from several
OES from exposure to drinking water, incidental dermal or incidental
oral exposure in ambient waters. The estimated exposure values for the
screening level assessed water pathway resulted in estimated acute
noncancer, chronic noncancer, or cancer risk for relative to their
respective benchmark values for various evaluated OESs (Ref. 79).
    The drinking water analysis modeled a total of 101 releases across
all OES for the 20-day release scenario, and modeled a total of 103
releases for the maximum days of release scenario. For the drinking
water exposure, risks relative to the benchmark for the acute non-
cancer developmental endpoint for both the 20-day and maximum days of
release scenarios for at least one facility in each of the following
OES: Manufacturing; Processing as a Reactant; Degreasing; Repackaging;
Process Solvent Recycling; Adhesives, Sealants, Paints and Coatings;
Industrial Processing Aid, and Other Industrial Uses. For drinking
water exposures, at least one facility indicated an increased cancer
risk at or above 1 in 1,000,0000 (but less than 1 in 100,000) for both
the 20-day and maximum days of release scenarios for the Degreasing and
Repackaging OES. EPA did not identify source water drinking water
intakes for public drinking water systems within 10 miles downstream of
facilities with known locations discharging to identifiable
waterbodies. No risks relative to acute or chronic exposures for the
immune endpoint or for chronic exposures for the developmental endpoint
benchmarks were identified for any OES for drinking water exposures;
for the immune endpoint, estimated margins of exposure were at least 4-
fold higher than benchmarks.
    For the incidental oral exposure in ambient water, a total of 113
releases were modeled across all OES for the 20-day release scenario,
and a total of 115 releases were modeled across all OES for the maximum
days of release scenario. Risks relative to the benchmark were
identified for at least one facility for the acute non-cancer
developmental endpoint under the 20-day scenarios for Processing as a
Reactant; Degreasing; Repackaging; Process Solvent Recycling;
Adhesives, Sealants, Paints, and Coatings; and Other Industrial Uses
OESs were identified for the 20-days of release scenario. For the
maximum days of release scenario, risks relative to the benchmark for
the acute developmental endpoint were identified for: Processing as a
Reactant and Degreasing. For the immune endpoint, no risks were
identified relative to the acute exposures benchmark. For chronic
scenarios, risk was identified relative to the benchmarks for both the
immune and developmental endpoints for the 20-day and maximum days of
release scenarios. Specifically, at least one facility in the
Degreasing OES was identified as showing risk relative to both
endpoints for the maximum risk scenarios for both types of releases
(20-day and maximum), and at least one facility in the Processing as a
Reactant OES was identified as showing risk relative to the
developmental endpoint for both the 20-day and maximum release
scenarios.
    Similarly, for the incidental dermal exposure in ambient waters
pathway, a total of 113 releases were modeled across all OES for the
20-day release scenario, and a total of 115 releases were modeled
across all OES for the maximum days of release scenario. For both
incidental oral and incidental dermal exposures, EPA did not assess
cancer risk because repeated exposures are not expected to continue
across a lifetime. For acute scenarios, risk was identified for at
least one facility relative to both the immune and developmental
endpoints for the 20-day and maximum release scenarios. For 20-day
release scenarios, the immune endpoint had identified risk relative to
the benchmark for at least one facility in the Degreasing OES, while
the developmental endpoint had identified risk relative to the
benchmark for the at least one facility in the following OES:
Processing as a Reactant; Degreasing; Repackaging; Process Solvent
Recycling; Adhesives, Sealants, Paints, and Coatings; Industrial
Processing Aid; and Other Industrial Uses. For the maximum days of
release scenarios, risk relative to the developmental endpoint was
identified for at least one facility in the Processing as a Reactant
and the Degreasing OES. For chronic scenarios, risk was identified
relative to both the immune and developmental endpoint benchmarks for
at least one facility for both the 20-day and maximum days of release
scenarios. For 20-day release scenarios, the Processing as a Reactant
and Degreasing OES had risks identified relative to the immune and
developmental endpoint benchmarks; for the maximum days release
scenarios, the Processing as a Reactant and Degreasing OES had risks
identified relative to the immune and developmental endpoint
benchmarks.
    Overall, for the analysis of the water pathway, EPA identified
potential risks that exceed the benchmark for non-cancer endpoints from
several facilities, representing benchmark exceedances between 1 and 10
OES, depending on whether the drinking water, incidental oral, or
incidental dermal exposures are considered. In each case for the
screening level analysis, risks were identified only for the maximum
risk scenarios (or facilities with the highest reported results), and
for a relatively

small number of facilities. In instances where a facility may be
engaging in a condition of use with a longer phase-out, EPA notes that
in no instances did EPA identify drinking water intakes within 10 miles
of a discharging facility, and emphasizes that the scenarios analyzed
include significant uncertainties and assumptions within the high-end
risk estimates due to reliance on the highest-reported results from
several facilities (Ref. 79). Regarding cancer risks, while the
analysis identified facilities with some indication of releases and
potential drinking water exposure with associated increased cancer risk
that exceeds more than 1 in 1,000,000, the analysis did not identify
any facilities exceeding more than 1 in 10,000; the highest potential
risk estimate is in the 1 in 100,000 range (Ref. 79).
    Under the proposed regulatory action described in Unit V.A., all
conditions of use would ultimately be prohibited and so any potential
risk indicated by this screening analysis would be eliminated. In
particular, under the proposed regulatory action the disposal of TCE to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works would be prohibited. The risks to fenceline communities
from exposure through water further strengthen the impetus for EPA's
prohibition of TCE. EPA therefore does not intend to revisit the water
pathway for TCE as part of a supplemental risk evaluation.

B. Environmental Effects of TCE and the Magnitude of Exposure of the
Environment to TCE

    EPA's analysis of the environmental effects of TCE and the
magnitude of exposure of the environment to TCE are in the 2020 Risk
Evaluation for TCE (Ref. 1). The unreasonable risk determination for
TCE is based solely on risks to human health (Ref. 2); based on the
TSCA 2020 Risk Evaluation for TCE, EPA determined that exposures to the
environment did not drive the unreasonable risk. A summary is presented
here.
    For all conditions of use, amphibian, fish, and aquatic
invertebrate acute and chronic exposures to TCE do not drive the
unreasonable risk. To characterize the exposure to TCE by aquatic
organisms, EPA assessed environmental exposures derived from predicted
and measured concentrations of TCE in surface water in the U.S.
Specifically, the aquatic exposures associated with the industrial and
commercial conditions of use were predicted through modeling, and the
aquatic exposure assessment also includes an analysis of collected
measured surface water concentrations from monitoring data. EPA
considered the biological relevance of the species to determine the
concentrations of concern for the location of surface water
concentration data to produce risk quotients, as well as frequency and
duration of the exposure. EPA determined that the evaluation does not
support an unreasonable risk determination to aquatic organisms.
    The toxicity of TCE to sediment-dwelling invertebrates is similar
to the toxicity to aquatic invertebrates. TCE is expected to remain in
aqueous phases and not adsorb to sediment due to its water solubility
and low partitioning to organic matter. TCE has relatively low
partitioning to organic matter and biodegrades slowly, so TCE
concentrations in sediment pore water are expected to be similar to the
concentrations in the overlying water or lower in the deeper part of
sediment where anaerobic condition prevails. Thus, the TCE detected in
sediments is likely from the pore water. Therefore, for sediment-
dwelling organisms, the risk estimates, based on the highest ambient
surface water concentration, do not support an unreasonable risk
determination to sediment-dwelling organisms from acute or chronic
exposures.
    For terrestrial organisms, TCE exposure is expected to be low since
physical-chemical properties do not support an exposure pathway through
water and soil pathways to these organisms. Therefore, for terrestrial
organisms, the risk estimates, based on the EPA 2003 Guidance for
Ecological Soil Screening Levels, do not support an unreasonable risk
determination from acute or chronic exposures.

C. Benefits of TCE for Various Uses

    TCE has a wide range of uses, including as an intermediate during
the manufacture of refrigerants, specifically HFC-134a, and is also
used as a solvent, frequently in cleaning and degreasing (including
spot cleaning, vapor degreasing, cold cleaning, and aerosol
degreasing). A variety of consumer and commercial products use TCE as
adhesives and sealants, in paints and coatings, and in other
miscellaneous products. TCE is subject to Federal and State regulations
and reporting requirements.
    The largest uses of TCE, by production volume, are for processing
as a reactant/intermediate as well as aerosol and vapor degreasing
uses. Based on the 2020 Risk Evaluation for TCE, over 84% of the
production volume of TCE is processed as a reactant/intermediate, the
majority of the volume is for TCE processed as an intermediate in the
production of HFC-134a, a refrigerant widely used in a broad range of
applications. The second largest use of TCE is in industrial and
commercial uses for aerosol and vapor degreasing. TCE is a relatively
inexpensive solvent useful for cleaning contaminated metal parts and
other fabricated materials (Ref. 3).
    TCE has many other uses, which, based on the 2020 Risk Evaluation
for TCE, collectively constitute about 1% of the production volume
(Ref. 1). In battery separator manufacturing, TCE is used as an
extraction solvent to produce the desired porosity in lead-acid and
lithium battery separators, which are essential to power vehicles and
systems in the U.S. supply chain.

D. Reasonably Ascertainable Economic Consequences of the Proposed Rule

1. Likely Effect of the Rule on the National Economy, Small Business,
Technological Innovation, the Environment, and Public Health
    The reasonably ascertainable economic consequences of this proposed
rule include several components, all of which are described in the
Economic Analysis for this proposed rule (Ref. 3). With respect to the
anticipated effects of this proposed rule on the national economy, EPA
considered the number of businesses and workers that would be affected
and the costs and benefits to those businesses and workers and did not
find that there would be an impact on the national economy (Ref. 3).
The economic impact of a regulation on the national economy becomes
measurable only if the economic impact of the regulation reaches 0.25%
to 0.5% of Gross Domestic Product (GDP) (Ref. 80). Given the current
(real) GDP [of $60.4 trillion (2022)], this is equivalent to a cost of
$151 billion to $302 billion. Therefore, because EPA has estimated that
the monetized cost of the proposed rule would range from $33.1 million
annualized over 20 years at a 3% discount rate and $40.6 million
annualized over 20 years at a 7% discount rate, EPA has concluded that
this action is highly unlikely to have any measurable effect on the
national economy (Ref. 3). EPA does not have data to quantify
employment impacts of the proposed rule, and large employment impacts
are not expected. Instead, workers currently using TCE are expected to
continue employment while shifting away from TCE use and towards
alternatives. However, EPA acknowledges that transitional employment
impacts may be

experienced by some workers at facilities that opt to close or shift
operations abroad instead of complying with requirements at the
facilities currently using TCE. EPA considered the employment impacts
of this proposed rule, and found that the direction of change in
employment is uncertain, but EPA expects the short-term and longer-term
employment effects to be small.
    Of the small businesses potentially impacted by this proposed rule,
99.1% are expected to have impacts of less than 1% to their firm
revenues, 0.5% are expected to have impacts between 1 and 3% to their
firm revenues, and 0.4% are expected to have impacts greater than 3% to
their firm revenues. The largest segment of businesses that would be
affected by this regulation are commercial users of liquid and aerosol
degreasers. Costs of alternatives were found to be both higher and
lower than products containing TCE. For most product types,
alternatives with similar efficacy are available with costs that both
lower and higher than TCE products. However, there may be some
applications where TCE is more effective, reducing labor time and wait
time, and or where extensive safety testing might be required. EPA was
unable to quantify these costs.
    With respect to this proposed rule's effect on technological
innovation, EPA expects this action to spur more innovation than it
will hinder. A prohibition or significant restriction on the
manufacture, processing, and distribution in commerce of TCE for uses
covered in this proposed rule may increase demand for safer chemical
substitutes. This proposed rule is not likely to have significant
effects on the environment because TCE does not present an unreasonable
risk to the environment, though this proposed rule does present the
potential for small reductions in air emissions and soil contamination
associated with improper disposal of products containing TCE. The
effects of this proposed rule on public health are estimated to be
positive, due to the reduced risk of cancer and other non-cancer
endpoints from exposure to TCE.
2. Costs and Benefits of the Proposed Regulatory Action and of the One
or More Primary Alternative Regulatory Actions Considered by the
Administrator
    The costs and benefits that can be monetized for this proposed rule
are described at length in in the Economic Analysis (Ref. 3). The
monetized costs for this proposed rule are estimated to range from
$33.1 million annualized over 20 years at a 3% discount rate and $40.6
million annualized over 20 years at a 7% discount rate. The monetized
benefits are estimated to range from $18.1 to $21.5 million annualized
over 20 years at a 3% discount rate and $8.2 to $10.3 million
annualized over 20 years at a 7% discount rate.
    EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary alternative regulatory action is described in detail in Unit
V.B. The estimated annualized costs of the alternative regulatory
action are $34.4 million at a 3% discount rate and $41.2 million at a
7% discount rate over 20 years (Ref. 3). The monetized benefits of this
alternative regulatory action are estimated to range from $18.1 to
$21.5 million annualized over 20 years at a 3% discount rate and $8.2
to $10.3 million annualized over 20 years at a 7% discount rate over 20
years (Ref. 3).
    This proposal is expected to achieve health benefits for the
American public, some of which can be monetized and others that, while
tangible and significant, cannot be monetized. EPA believes that the
balance of costs and benefits of this proposal cannot be fairly
described without considering the additional, non-monetized benefits of
mitigating the non-cancer adverse effects. These effects may include
neurotoxicity, kidney toxicity, liver toxicity, immunological and
hematological effects, reproductive effects, and developmental effects.
The multitude of adverse effects from TCE exposure can profoundly
impact an individual's quality of life, as discussed in Unit II.A.
(overview), Unit III.B.2. (description of the unreasonable risk), Unit
V.A. (discussion of the health effects), and the 2020 Risk Evaluation
for TCE. Chronic adverse effects of TCE exposure include both cancer
and the non-cancer effects listed in this paragraph. Acute effects of
TCE exposure could be experienced for a shorter portion of life but are
nevertheless significant in nature. The incremental improvements in
health outcomes achieved by given reductions in exposure cannot be
quantified for non-cancer health effects associated with TCE exposure,
and therefore cannot be converted into monetized benefits. The
qualitative discussion throughout this rulemaking and in the Economic
Analysis highlights the importance of these non-cancer effects. These
effects include willingness-to-pay to avoid illness, which includes
cost of illness and other personal costs such as pain and suffering.
Considering only monetized benefits underestimates the impacts of TCE
adverse outcomes and therefore underestimates the benefits of this
proposed rule.
3. Cost Effectiveness of the Proposed Regulatory Action and of the 1 or
More Primary Alternative Regulatory Actions Considered by the
Administrator
    Cost effectiveness is a method of comparing certain actions in
terms of the expense per item of interest or goal. A goal of this
proposed regulatory action is to achieve the risk reduction standard in
a [more] cost-effective manner, with estimated [lower] costs and
[higher] net benefits, than other considered alternative regulatory
actions (Ref. 3). The proposed regulatory action would cost $6.8-7.7
million per potential prevented cancer case while the primary
alternative regulatory action would cost $7.1-8.0 million (using the 3%
discount rate) to achieve the same goals. While the primary alternative
regulatory action is lower in cost compared to the proposed regulatory
action, the difference is small (Ref. 3).

VIII. TSCA Section 9 Analysis, Section 14, and Section 26
Considerations

A. TSCA Section 9(a) Analysis

    TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency following submission of any such report.
As discussed in this unit, for this proposed rule, the Administrator
proposes to exercise his discretion not to determine that the
unreasonable risk from TCE under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA.
    In addition, TSCA section 9(d) instructs the Administrator to
consult and coordinate TSCA activities with other Federal agencies for
the purpose of achieving the maximum enforcement of TSCA while imposing
the least burdens of duplicative requirements. For this proposed rule,
EPA has and continues to coordinate with appropriate Federal executive
departments and agencies including OSHA and the Consumer Product Safety
Commission (CPSC), to, among other things, identify their respective

authorities, jurisdictions, and existing laws with regard to TCE, which
are summarized in this unit.
    OSHA requires that employers provide safe and healthful working
conditions by setting and enforcing standards and by providing
training, outreach, education and assistance. As described in Unit
II.C., OSHA, in 1971, established a PEL for TCE of 100 ppm of air as an
8-hour TWA with an acceptable ceiling concentration of 200 ppm and an
acceptable maximum peak above the acceptable ceiling concentration for
an eight-hour shift of 300 ppm, maximum duration of 5 minutes in any 2
hours. However, the exposure limits established by OSHA are higher than
the exposure limit that EPA determined would be sufficient to address
the unreasonable risk identified under TSCA from occupational
inhalation exposures associated with certain conditions of use. Gaps
exist between OSHA's authority to set workplace standards under the OSH
Act and EPA's obligations under TSCA section 6 to eliminate
unreasonable risk presented by chemical substances under the conditions
of use. Health standards issued under section 6(b)(5) of the OSH Act
must reduce significant risk only ``to the extent feasible.'' 29 U.S.C.
655(b)(5). To set PELs for chemical exposure, OSHA must first establish
that the new standards are economically and technologically feasible
(79 FR 61384 and 61387, Oct. 10, 2014). But under TSCA section 6(a),
EPA's substantive burden is to demonstrate that, as regulated, the
chemical substance no longer presents an unreasonable risk, with
unreasonable risk being determined without consideration of costs or
other nonrisk factors. Thus, if OSHA were to initiate a new action to
lower its PEL, the difference in standards between the OSH Act and TSCA
may well result in the OSHA PEL being set at a higher level than the
exposure limit that EPA determined would be sufficient to address the
unreasonable risk under TSCA.
    In addition, OSHA may set exposure limits for workers, but its
authority is limited to the workplace and does not extend to consumer
uses of hazardous chemicals, and thus OSHA cannot address the
unreasonable risk from TCE under all of its conditions of use, which
include consumer uses. OSHA also does not have direct authority over
State and local employees, and it has no authority over the working
conditions of State and local employees in States that have no OSHA-
approved State Plan under 29 U.S.C. 667.
    CPSC, under authority provided to it by Congress in the CPSA,
protects the public from unreasonable risk of injury or death
associated with the use of consumer products. Under the CSPA, CPSC has
the authority to regulate TCE in consumer products, but not in other
sectors such as automobiles, industrial and commercial products, or
aircraft for example (Ref. 81). Further, a consumer product safety rule
under the CPSA must include a finding that ``the benefits expected from
the rule bear a reasonable relationship to its costs,'' 15 U.S.C.
2058(f)(3)(E), whereas EPA must apply TSCA risk management requirements
to the extent necessary so that the chemical no longer presents
unreasonable risk and only consider costs and benefits of the
regulatory action to the extent practicable, 15 U.S.C. 2605(a), (c)(2).
Additionally, the 2016 amendments to TSCA reflect Congressional intent
to ``delete the paralyzing `least burdensome' requirement,'' 162 Cong.
Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as
originally enacted, which required EPA to use ``the least burdensome
requirements'' that protect ``adequately'' against unreasonable risk,
15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under
the CPSA must impose ``the least burdensome requirement which prevents
or adequately reduces the risk of injury for which the rule is being
promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at
variance with recent revisions to TSCA, affect the availability of
action CPSC may take under the Federal Hazardous Substances Act (FHSA)
relative to action EPA may take under TSCA. 15 U.S.C. 1262.
    EPA therefore concludes that TSCA is the only regulatory authority
able to prevent or reduce unreasonable risk of TCE to a sufficient
extent across the range of conditions of use, exposures, and
populations of concern. This unreasonable risk can be addressed in a
more coordinated, efficient, and effective manner under TSCA than under
different laws implemented by different agencies. Moreover, the
timeframe and any exposure reduction as a result of updating OSHA or
CPSC regulations cannot be estimated, while TSCA requires a much more
accelerated 2-year statutory timeframe for proposing and finalizing
regulatory requirements to address unreasonable risk. Further, there
are key differences between the finding requirements of TSCA and those
of the OSH Act, CPSA, and FHSA. For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk from TCE may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. However, EPA is requesting public comment
on this issue (i.e., the sufficiency of an action taken under a Federal
law not administered by EPA).

B. TSCA Section 9(b) Analysis

    If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk unless
the Administrator determines in the Administrator's discretion that it
is in the public interest to protect against such risk under TSCA. In
making such a public interest finding, TSCA section 9(b)(2) states:
``the Administrator shall consider, based on information reasonably
available to the Administrator, all relevant aspects of the risk . . .
and a comparison of the estimated costs and efficiencies of the action
to be taken under this title and an action to be taken under such other
law to protect against such risk.''
    Although several EPA statutes have been used to limit TCE exposure
(Ref. 9), regulations under those EPA statutes have limitations because
they largely regulate releases to the environment, rather than
occupational or consumer exposures. While these limits on releases to
the environment are protective in the context of their respective
statutory authorities, regulation under TSCA is also appropriate for
occupational and consumer exposures and in some cases can provide
upstream protections that would prevent the need for release
restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)).
    The primary exposures and unreasonable risk to consumers,
bystanders, workers, and ONUs would be addressed by EPA's proposed
prohibitions and restrictions under TSCA section 6(a). In contrast, the
timeframe and any exposure reduction as a result of updating
regulations for TCE under the CAA, CWA, or RCRA cannot be estimated,
nor would they address the direct human exposure to consumers,
bystanders, workers, and ONUs from the conditions of use evaluated in
the 2020 Risk Evaluation for TCE. More specifically, none of EPA's
other statutes (e.g., RCRA, CAA, CWA) can address exposures to workers
and ONUs related to the specific

activities that result in occupational exposures, for example those
associated with RCRA covered disposal requirements, such as in 40 CFR
261.24 and 40 CFR 268.3. EPA therefore concludes that TSCA is the most
appropriate regulatory authority able to prevent or reduce risks of TCE
to a sufficient extent across the range of conditions of use,
exposures, and populations of concern.
    For these reasons, the Administrator does not determine that
unreasonable risk from TCE under the conditions of use evaluated in the
2020 TSCA Risk Evaluation for TCE, could be eliminated or reduced to a
sufficient extent by actions taken under other Federal laws
administered in whole or in part by EPA.

C. TSCA Section 14 Requirements

    EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI that may occur
if this rulemaking is finalized as proposed. Under TSCA section
14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that
establishes a ban or phase-out of a chemical substance, the protection
from disclosure of any CBI regarding that chemical substance and
submitted pursuant to TSCA will be ``presumed to no longer apply,''
subject to the limitations identified in TSCA section 14(b)(4)(B)(i)
through (iii). If this rulemaking is finalized as proposed, then
pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against
protection from disclosure would apply only to information about the
specific conditions of use that this rulemaking would prohibit or phase
out. Manufacturers or processors seeking to protect such information
would be able to submit a request for nondisclosure as provided by TSCA
sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure
would need to be submitted within 30 days after receipt of notice from
EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such
notice via the Central Data Exchange or CDX.

D. TSCA Section 26 Considerations

    In accordance with TSCA section 26(h), EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science.
As in the case of the unreasonable risk determination, risk management
decisions for this proposed rule, as discussed in Unit III.B.3. and
Unit V., were based on a risk evaluation, that was subject to public
comment and independent, expert peer review, and was developed in a
manner consistent with the best available science and based on the
weight of the scientific evidence as required by TSCA sections 26(h)
and (i) and 40 CFR 702.43 and 702.45.
    In particular, the ECEL values considered for the WCPP are derived
from the analysis in the 2020 Risk Evaluation for TCE. The proposed
ECEL value of 0.0011 ppm as an 8-hour TWA 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). This is the concentration at which an adult human would be
unlikely to experience the specified adverse effects if exposed for a
working lifetime, including susceptible subpopulations. Similarly, the
ECEL identified under the primary alternative regulatory option, based
on a different health endpoint, immunotoxicity, is derived from the
analysis in the 2020 Risk Evaluation for TCE. This ECEL is 0.0040 ppm
as an 8-hour TWA which is based on the chronic non-cancer occupational
HEC for autoimmunity (Ref. 14). As discussed in Unit VI.A., 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). Therefore, reducing exposures
remaining above the ECEL of 0.0040 ppm would reduce the contribution to
the unreasonable risk of injury to health driven by inhalation
exposures in an occupational setting for those conditions of use
identified as presenting unreasonable risk in the 2020 Risk Evaluation
for TCE under TSCA (Ref. 1, 14).
    The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decisions have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rulemaking. Additional information on the peer review and
public comment process, such as the peer review plan, the peer review
report, and the Agency's response to comments, can be found in EPA's
risk evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0737).

IX. Requests for Comment

    EPA is requesting public comment on all aspects of this proposal,
including the proposed and primary alternative regulatory actions and
all individual elements of these, and all supporting analysis.
Additionally, within this proposal, the Agency is soliciting feedback
from the public on specific issues throughout this proposed rule. For
ease of review, this unit summarizes those specific requests for
comment.
    1. EPA is requesting public comment on all elements of the proposed
regulatory action and the primary alternative regulatory action.
    2. EPA is requesting public comment regarding the need for
exemptions from the rule (and under what specific circumstances),
including exemptions from the proposed regulatory action and the
primary alternative regulatory action, pursuant to the provisions of
TSCA section 6(g).
    3. EPA requests comment on information that would allow EPA to
quantify the magnitude of avoided risk of fetal cardiac defects due to
reductions in TCE exposure under the proposed rulemaking.
    4. EPA requests comment on whether EPA should promulgate
definitions for each condition of use evaluated in the 2020 Risk
Evaluation for TCE, and, if so, whether the descriptions in Unit
III.B.1. are consistent with the conditions of use evaluated in the
2020 Risk Evaluation for TCE and whether they provide a sufficient
level of detail to improve the clarity and readability of the
regulation.
    5. EPA requests comment on the proposed compliance dates for
prohibitions of TCE manufacturing, processing, distribution in
commerce, and use and 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.
    6. 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.''
    7. EPA 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 Units V.A.1.b. and
c., and, if so, information on and rationale for any level that should
be considered de minimis.
    8. 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.
    9. EPA is seeking comment on the actions that manufacturers who
process TCE for the production of HFC-134a would take as a result of
the proposed phaseout in Unit V.A.1.d, and whether this would motivate
a decision to cease manufacture earlier than they would otherwise under
the AIM Act phase-down.
    10. 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 and what
those alternative disposal methods would be, and their cost and
feasibility.
    11. 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.
    12. 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.
    13. EPA is requesting comment on the use of the ECEL value of
0.0040 ppm in the WCPP in the alternative regulatory action.
    14. 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, as further detailed in Unit IV.A.
    15. EPA is requesting comment on personal air sampling devices that
are capable of detecting indoor air TCE concentrations at or below the
proposed ECEL action level of 0.00055 ppm (0.0029 mg/m\3\) with the
requisite precision and accuracy.
    16. EPA is requesting 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, as described further in Unit V.A.2.b.i.
    17. EPA requests comments regarding replacing the proposed
prohibitions with compliance with the WCPP, in the instance that
regulated entities are able to consistently demonstrate compliance with
an ECEL through effective controls.
    18. EPA requests 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.
    19. EPA requests comment on the feasibility of controlling worker
exposures to TCE at or below the proposed ECEL, and the accuracy of
detections measurements at this level.
    20. EPA requests 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.
    21. 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.
    22. 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 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.
    23. 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 the OSHA PEL action level (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..
    24. EPA requests 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.
    25. 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. EPA is also
soliciting comments regarding use of area source monitoring instead of
personal breathing zone as a representative sample of exposures.
    26. EPA requests comment on the timeframes for periodic monitoring
outlined in Table 1 of Unit V.A.2.
    27. 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.

    28. EPA is 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).
    29. 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, 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.
    30. EPA is requesting comment on whether the timeframe to provide
PPE to exposed workers 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, as discussed in
Unit V.A.2.
    31. 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.
    32. 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.
    33. 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
Unit V.A.2., including establishment of a respiratory protection
program and development of an exposure plan.
    34. 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.
    35. EPA also 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 Unit V.A.2.
    36. EPA requests comment on whether 10 years is an appropriate
timeframe for the 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).
    37. EPA requests comment on whether 50 years is an appropriate
timeframe for the TSCA section 6(g) exemption for the industrial and
commercial use of TCE as a laboratory chemical (specifically in lab use
essential for essential laboratory activities), Specifically, EPA
requests comment on the anticipated duration of TCE cleanup projects,
and whether there will be projects that continue and require the use of
TCE as a laboratory chemical for the analysis of contaminated soil,
air, and water samples past 50 years.
    38. EPA requests comment on the TSCA section 6(g) exemption for
continued emergency use of TCE in the furtherance of NASA's mission as
described in Unit V.A.3.iii.a.vi, and whether any additional conditions
of use should be included, in particular for any uses qualified for
space flight for which no technically or economically feasible safer
alternative is available. Additionally, EPA requests comment on what
would constitute sufficient justification of an emergency.
    39. EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in Unit V.A.2.
    40. EPA requests comment on the primary alternative regulatory
action and whether any elements of this primary alternative regulatory
action described in Unit IV.B. should be considered as EPA develops the
final regulatory action. EPA also requests comment on the
practicability of the timeframes under the primary alternative
regulatory action outlined in Unit V.B. compared to the timeframes
identified for the proposed regulatory action in Unit V.A.
    41. EPA requests comment on the practicability of the timeframes
outlined for the phaseout of processing TCE as an intermediate for HFC-
134a manufacture in Unit V.B. compared to the timeframes identified for
the proposed regulatory action in Unit V.A., including consideration of
the need for manufacturing (including import), and distribution in
commerce to continue during the period of the phaseout.
    42. 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 for
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.
    43. EPA requests comment on whether the three-year alternative
timeline would be practicable or whether additional time is needed, for
example, for a regulated entity to implement a change to their
wastewater collection, treatment, or disposal processes or
infrastructure, and what those alternative disposal methods may be.
    44. EPA requests comment on the ability of regulated entities to
conduct initial monitoring within 12 months, anticipated timeframes for
any procedural adjustments needed to comply with the requirements, and
the extent to which this option could result in additional exposure,
compared to the proposed regulatory option as described in Unit V.A.
    45. EPA requests comment on the practicability of the timeframes
outlined in this unit, when compared to the timeframes identified for
the proposed regulatory action in Unit V.A. EPA requests comment on
whether any elements of the primary alternative regulatory action
described in this unit should be considered as EPA develops the final
regulatory action, e.g., whether EPA should consider the timeframes for
implementation of a WCPP presented in this primary alternative
regulatory action and the ECEL value presented in the proposed
regulatory action.
    46. EPA requests comment on the existing practices (e.g.,
engineering controls, administrative controls, PPE) involving TCE use
in these conditions of use, as to whether activities may take place in
closed systems and the degree to which users of TCE in these sectors
could successfully implement an ECEL of 0.0011 ppm or an ECEL of 0.0040
ppm as an 8-hour TWA, dermal protection, and ancillary requirements
described in Units V.A.2. and V.B.2.
    47. EPA requests comment on the extent to which the use of TCE for
vapor

degreasing of narrow tubing is a critical use for which no technically
and economically feasible safer alternative is available.
    48. EPA therefore requests comment on the Agency's consideration of
an exemption from the prohibition on disposal of TCE by industrial pre-
treatment, industrial treatment, or publicly owned treatment works for
cleanup projects undertaken under the authority of CERCLA, RCRA, or
other federal, state, or local government environmental laws,
regulations, or requirements.
    49. EPA requests comment on whether 50 years is a reasonable
timeframe for a TSCA section 6(g)(1)(A) exemption for the cleanup of
TCE-contaminated water and groundwater sites. Specifically, EPA
requests comment on the anticipated duration of TCE cleanup projects,
and whether there will be projects that may continue and require the
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works beyond 25 years.
    50. EPA requests comment on whether industry anticipates increased
releases of TCE to outdoor air associated with the implementation of
the WCPP. 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.
EPA is also soliciting comment on the frequency and nature of air
monitoring EPA should consider including as requirements in the final
rule.
    51. EPA requests comments on all aspects of the TSCA section 6(g)
exemptions described in Units V.A.3. and V.B.3., including whether
compliance with the WCPP should also be required during the period of
the exemption.
    52. EPA is soliciting comment on if the exemption for laboratory
use of TCE as described in Unit V.A.3.a.iii should include lab use of
TCE for research and development purposes for objectives broader than
cleanup activities or exposure monitoring, such as research into TCE
alternatives, whether these broader objectives should be limited to
federal agencies and their contractors or expanded to include others,
and whether a shorter time period, such as 10 years, should be imposed
on these broader research and development activities.
    53. EPA is soliciting comment on whether it should specify the type
of batch vapor degreasing operation, such as open-top or closed loop
batch vapor degreasing, that would be exempt from prohibition as part
of the primary alternative regulatory action for the industrial and
commercial use of TCE in batch vapor degreasing for essential aerospace
parts and narrow tubing used in medical devices and whether EPA should
consider different exemption timeframes for different types of vapor
degreasing operations.
    54. EPA requests comments on subsections of conditions of use,
which by nature of their infrequent occurrence, could meet the ECEL
without having their employees wear high APF levels of PPE on a daily
basis.
    55. EPA requests public comment on the rationale for proposing
prohibitions as the preferred risk management approach. In addition,
EPA requests comment regarding the number of businesses and other
entities that could potentially close as well as associated costs with
a prohibition of TCE for the industrial and commercial conditions of
use identified in Unit V.A.1.
    56. EPA requests comment on the effectiveness of a limited access
program, such as a point-of-sale self-certification or other
administrative controls, to address the unreasonable risk of TCE, in
particular for facilities with occupational exposures to TCE that may
not be able to meet the WCPP requirements of this proposed rulemaking.
    57. EPA is soliciting comments on whether there are products in use
or available for sale relevant to these conditions of use that contain
TCE at this time, so that EPA can ascertain whether there are
alternatives that benefit human health or the environment as compared
to such use of TCE.
    58. EPA is requesting comment on the Alternatives Assessment as a
whole.
    59. EPA is requesting public comment on an issue raised in its TSCA
section 9(a) Analysis described in Unit VIII.A., (i.e., the sufficiency
of an action taken under a Federal law not administered by EPA).
    60. Following Panel report recommendations (Ref. 32) and in
response to input provided by SERs, EPA is requesting comment on the
following topics as outlined in the SBAR Panel Report:
     EPA requests public comment on the extent to which a
regulation under TSCA section 6(a) could minimize requirements, such as
testing and monitoring protocols, recordkeeping, and reporting
requirements, which may exceed those already required under OSHA's
regulations for TCE.
     EPA requests public comment on reasonable compliance
timeframes for small businesses, specifically on whether and how to
provide longer compliance timeframes for transitioning to alternatives
for uses requiring reformulation and cleaning processes for cleaning
parts for national defense or cleaning medical devices.
     EPA requests public comment on differing compliance or
reporting requirements or timetables that account for the resources
available to small entities.
     EPA requests public comment on any additional appropriate
factors for identifying reasonable compliance timeframes and how to
weigh the factors for vapor degreasing and other industries.
     EPA requests public comment the feasibility of entities
complying with and monitoring for a potential ECEL of either 0.0011 ppm
or 0.0040 ppm, specifically regarding potential costs that could be
incurred using strategies to meet the requirements of such a standard,
such as engineering, administrative, or prescriptive controls and how
feasible it would be for entities to implement these strategies in
their operations.
     EPA requests public comment on the feasibility of use of
alternatives to TCE and their availability for conditions of use that
drive the unreasonable risk.
     EPA requests public comment on a training and
certification program for a commercial user to obtain a TCE-containing
product from a retailer, such as industrial supply stores or online
retailers.
     EPA requests public comment on a de minimis level in the
case of an impurity or trace amounts of TCE in products.
     EPA requests public comment on whether to allow the use of
TCE by entities that could, based on demonstrated ability through
monitoring data, meet the ECEL under a workplace chemical protection
program.
     EPA requests public comment on how the rulemaking should
consider TCE alternatives in light of ongoing regulatory scrutiny.
     EPA requests public comment on whether chemicals
undergoing risk evaluation would be likely to be

considered as viable alternatives and, if so, in which circumstances.
     EPA requests public comment on potential challenges
associated with monitoring TCE below 0.0011 ppm and 0.0040 ppm.
     EPA requests public comment on whether the use of TCE in a
closed-loop vapor degreasing system, when combined with requirements of
a potential workplace chemical protection program, could meet the ECELs
for TCE.

X. References

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

1. EPA. Risk Evaluation for Trichloroethylene. EPA Document
#740R18008. November 2020.
2. EPA. Final Revised Unreasonable Risk Determination for
Trichloroethylene, Section 5. December 2022.
3. EPA. Economic Analysis of the Proposed Regulation of
Trichloroethylene. 2023.
4. EPA. Phasedown of Hydrofluorocarbons: Establishing the Allowance
Allocation and Trading Program Under the American Innovation and
Manufacturing Act; Final Rule. October 5, 2021.
5. A. Tinker et al. Inpatient Hospitalization Costs Associated with
Birth Defects Among Persons of All Ages--United States, 2013. MMWR.
Morbidity and mortality weekly report vol. 66,2 41-46. January 20,
2017.
6. M. Chen et al. Children with Heart Conditions and Their Special
Health Care Needs--United States, 2016. MMWR. Morbidity and
mortality weekly report vol. 67,38 1045-1049. 28. Sept. 28, 2018.
7. N. McClung et al. Financial burdens and mental health needs in
families of children with congenital heart disease. Congenital heart
disease 13.4 (2018): 554-562. April 6, 2018.
8. EPA. ChemView: Trichloroethylene (TCE), 79-01-6. Last updated on
June 2, 2023. https://chemview.epa.gov/chemview/?tf=0&ch=79-01-6&su=256737574985&as=31098∾=115166378999&ma=4-11-1981377-4_16848473-4_16848474-4_49007566&gs=&tds=0&tdl=10&tas1=1&tas2=asc&tas3=undefined&tss=&modal=detail&modalId=100616&modalSrc=2-5-10-1-6378999-4-11-1981377.
9. EPA. Summary of EPA Regulations Pertaining to Trichloroethylene
(TCE); and Other Federal, State, and International Regulations.
September 2023.
10. OSHA. Standard Interpretations: 8-hr total weight average (TWA)
permissible exposure limit (PEL). December 18, 2003. https://www.osha.gov/laws-regs/standardinterpretations/2003-12-18-1.
11. EPA. Trichloroethylene (TCE); Revision to the Toxic Substances
Control Act (TSCA) Risk Determination; Notice of Availability.
Federal Register (88 FR 1222, January 9, 2023) (FRL-9945-02-OCSPP).
12. NIOSH. Hierarchy of Controls. Last Reviewed January 17, 2023.
https://www.cdc.gov/niosh/topics/hierarchy/.
13. EPA. Second Existing Chemical Exposure Limit (ECEL)
(Developmental Toxicity) for Occupational Use of Trichloroethylene.
March 31, 2022.
14. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Trichloroethylene. February 22, 2021.
15. AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992).
16. ACGIH. ACGIH TLVs. n.d. https://www.acgih.org/trichloroethylene/.
17. NIOSH. NIOSH Pocket Guide to Chemical Hazards--
Trichloroethylene. Last Reviewed October 30, 2019. https://www.cdc.gov/niosh/npg/npgd0629.html.
18. NIOSH. Appendix A--NIOSH Potential Occupational Carcinogens.
Last Reviewed October 17, 2018. https://www.cdc.gov/niosh/npg/nengapdxa.html.
19. State of California Department of Industrial Relations. Table
AC-1 Permissible Exposure Limits For Chemical Contaminants. n.d.
https://www.dir.ca.gov/title8/5155table_ac1.html.
20. NIOSH. Recommendations for Occupational Safety and Health.
January 1992.
21. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 20, 2021).
22. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
23. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
24. EPA. EPA Announces Path Forward for TSCA Chemical Risk
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
25. EPA. TSCA Science Advisory Committee on Chemicals Meeting
Minutes and Final Report. March 24-27, 2020.
26. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
27. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE).
June 15 and July 8, 2021.
28. W. Heiger-Bernays and G. Nielsen. Environmental Justice
Consultation Comment 1 for TCE and PCE. July 5, 2021.
29. S. Rayasam. Environmental Justice Consultation Comment 2 for TCE
and PCE. June 16, 2021.
30. S. Liu. Environmental Justice Consultation Comment 3 for TCE and
PCE. August 20, 2021.
31. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and
Perchloroethylene (PCE). July 2021.
32. Small Business Advocacy Review Panel. Final Report of the Small
Business Advocacy Review Panel on EPA's Planned Proposed Rule for
Trichloroethylene (TCE). April 4, 2023.
33. EPA. Initial Regulatory Flexibility Analysis (IRFA) for Proposed
Regulation of Trichloroethylene.
34. EPA. Public Webinar on Trichloroethylene (TCE): Risk Evaluation
and Risk Management under TSCA Section 6. December 15, 2020.
35. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Trichloroethylene under TSCA Section 6(a). May 19, 2023.
36. EPA. 2021 Policy on Children's Health. October 5, 2021.
37. EPA. Problem Formulation of the Risk Evaluation for
Trichloroethylene. May 2018.
38. EPA. Scope of the Risk Evaluation for Trichloroethylene. June
2017.
39. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane.
August 2020.
40. EPA. Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain
Conditions of Use Under Section 6(a) of the Toxic Substances Control
Act (TSCA). April 12, 2022.
41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
42. EPA. Trichloroethylene (TCE); Revision to Toxic Substances
Control Act (TSCA) Risk Determination; Respone to Public Comments.
December 2022.
43. NASA. Solid Rocket Motor Nozzles Mission Critical Requirement
for Trichloroethylene. February 1, 2023.
44. OSHA. Occupational Exposure to Methylene Chloride. January 10,
1997.
45. EPA. Passive Samplers for Investigations of Air Quality: Method
Description, Implementation, and Comparison to Alternative Sampling
Methods. December 2014.
46. EPA. Second Existing Chemical Exposure Limit (ECEL)
(Developmental Toxicity) for Occupational Use of Trichloroethylene;
Appendix B. March 31, 2022.
47. OSHA. Personal Protective Equipment. 2023.
48. ENTEK. ENTEK International LLC, Request for Section 6(g)
Exemption. July 14, 2021.
49. Microporous. Microporous LLC (``Microporous''), Request for
Section 6(g) Exemption. August 10, 2022.
50. Battery Council International. Letter in Support of ENTEK
Request for Section 6(g) Exemption for Battery Separator
Manufacturing. September 3, 2021.

51. The Federal Consortium for Advanced Batteries. Executive Summary
National Blueprint For Lithium Batteries 2021-2030. June 2021.
52. ENTEK. Analysis of Alternatives for the use of trichloroethylene
as an extraction solvent for removal of process oil and formation of
the porous structure in polyethylene based separators used in lead-
acid batteries. August 2021.
53. EPA. Assistant Administrator Meeting with ENTEK on a TSCA
Section 6(g) Exemption Request in Risk Management for
Trichloroethylene (TCE). February 15, 2022.
54. ENTEK. Attachment B to July 14, 2021 Letter From ENTEK EPA.
55. European Chemical Agency. Adopted opinions and previous
consultations on applications for authorisation. n.d. https://echa.europa.eu/applications-for-authorisation-previous-consultations/-/substance-rev/6385/term; https://echa.europa.eu/applications-for-authorisation-previous-consultations/-/substance-rev/6384/term.
56. NASA. Known Uses of Trichloroethylene. December 14, 2022.
57. K. Black. The Nuclear Asphalt Content Gauge. 1995. https://highways.dot.gov/public-roads/winter-1995/nuclear-asphalt-content-gauge.
58. U.S. Department of State. A Strategic Framework for Space
Diplomacy. May 25, 2023.
59. M. Finckenor. Materials for Spacecraft. NASA. 2016.
60. The Boeing Company. Comments Supporting Request for Additional
Information on Trichloroethylene (TCE); Rulemaking Under TSCA
Section 6(a). May 6, 2022.
61. The Boeing Company. Comments Concerning Trichloroethylene (TCE);
Regulation of Use in Vapor Degreasing Under TSCA Section 6(a). May
19, 2017.
62. The Boeing Company. Information on FAA Certification. December
9, 2022.
63. 3M. 3M to Exit PFAS Manufacturing by the End of 2025. December
20, 2022. https://news.3m.com/2022-12-20-3M-to-Exit-PFAS-Manufacturing-by-the-End-of-2025.
64. Viant. Viant Comments on the November 2020 TCE Risk Evaluation.
November 17, 2021.
65. EPA. Meeting Summary--EPA Visit at the Integer facility in
Minneapolis, MN. October 19, 2017.
66. EPA. National Air Emission Standards for Hazardous Air
Pollutants: Halogenated Solvent Cleaning. May 3, 2007.
67. PPG. PPG TSCA Section 6(g) Exemption Request. June 29, 2023.
68. EPA. Trichloroethylene (TCE); Regulation of Use in Vapor
Degreasing Under TSCA Section 6(a). Federal Register. (82 FR 7432,
January 19, 2017)(FRL-9950-08).
69. NIOSH. NIOSH Guide to the Selection and Use of Particulate
Respirators. January 1996. https://www.cdc.gov/niosh/docs/96-101/default.html.
70. Arkema. Arkema Inc. Comments on Draft Toxic Substances Control
Act (TSCA) Risk Evaluation and TSCA Science Advisory Committee on
Chemicals (SACC) Meetings. April 27, 2020.
71. EPA. Alternatives Assessment for Proposed Regulation of
Trichloroethylene.
72. EPA. Meeting with Safechem on Risk Management under TSCA Section
6(a) for Trichloroethylene. March 23, 2023.
73. Koura. Production of R-134a. 2017.
74. National Cleaners Association. National Cleaners Association
Comments on the Phaseout of Trichloroethylene (TCE). February 13,
2023.
75. Axiall. Safety Data Sheet for Trichlorethylene. October 26,
2013.
76. EPA. EPA Response to Letter of Concern from Louisiana Department
of Environmental Quality's (LDEQ) and the Louisiana Department of
Health (LDH). October 12, 2022.
77. EPA. Memorandum Trichloroethylene (TCE): Fenceline Technical
Support--Ambient Air Pathway. March 3, 2022.
78. EPA. Draft TSCA Screening Level Approach for Assessing Ambient
Air and Water Exposures to Fenceline Communities. January 2022.
79. EPA. Memorandum Trichloroethylene: Fenceline Technical Support--
Water Pathway. March 24, 2023.
80. OMB. Memorandum for Guidance for Implementing Title II of the
Unfunded Mandates Reform Act (UMRA). March 31, 1995.
81. CPSC. Statutes. n.d. https://www.cpsc.gov/Regulations-Laws--Standards/Statutes.
82. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of
Trichloroethylene under TSCA Section 6(a); Proposed Rule (RIN 2070-
AK83). EPA ICR No. 2775.01. September 2023.

XI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review

    This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to OMB for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. EPA prepared an economic
analysis (Ref. 3) of the potential costs and benefits associated with
this action, which is available in the docket and is summarized in Unit
VI.D.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted to OMB under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared has
been assigned EPA ICR No. 2775.01 (Ref. 82). You can find a copy of the
ICR in the docket for this rulemaking, and it is briefly summarized
here.
    There are two primary provisions of the proposed rule that may
increase burden under the PRA. The first is downstream notification,
which would be carried out by updates to the relevant SDS and which
would be required for manufacturers, processors, and distributors in
commerce of TCE, who would provide notice to companies downstream upon
shipment of TCE about the prohibitions. The information submitted to
downstream companies through the SDS would provide knowledge and
awareness of the restrictions to these companies. The second primary
provision of the proposed rule that may increase burden under the PRA
is WCPP-related information generation, recordkeeping, and notification
requirements (including development of exposure control plans; exposure
level monitoring and related recordkeeping; development of
documentation for a PPE program and related recordkeeping; development
of documentation for a respiratory protection program and related
recordkeeping; development and notification to potentially exposed
persons (employees and others in the workplace) about how they can
access the exposure control plans, exposure monitoring records, PPE
program implementation documentation, and respirator program
documentation; and development of documentation demonstrating
eligibility for an exemption from the proposed prohibitions, and
related recordkeeping).
    Respondents/affected entities: Persons that manufacture (including
import), process, distribute in commerce, use, or dispose of TCE or
products containing TCE. See also Unit I.A.
    Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
    Estimated number of respondents: 22,113.
    Frequency of response: On occasion.
    Total estimated burden: 12,197 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,702,625 (per year), includes $722,586
annualized capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information

unless it displays a currently valid OMB control number. The OMB
control numbers for certain EPA regulations in 40 CFR are listed in 40
CFR part 9 and displayed on the form and instructions or collection
portal, as applicable.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this proposed rule. EPA will respond to ICR-related
comments in the final rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at https://www.reginfo.gov/public/do/PRAMain. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. OMB must receive comments
no later than November 30, 2023.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an initial regulatory flexibility analysis (IRFA) (Ref. 33)
that examines the impact of the proposed rule on small entities along
with regulatory alternatives that could minimize that impact. The
complete IRFA is available for review in the docket and is summarized
here.
1. Need for the Rule
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other nonrisk factors, including an
unreasonable risk to a PESS identified as relevant to the risk
evaluation, under the conditions of use, EPA must by rule apply one or
more requirements listed in TSCA section 6(a) to the extent necessary