$14.0 million annualized over 20 years at a 3% discount rate and $14.3
million annualized over 20 years at a 7% discount rate. The monetized
benefits are estimated to be $10.2 to $46.3 million annualized over 20
years at a 3% discount rate and $4.72 million to $29.4 million
annualized over 20 years at a 7% discount rate. Costs do not include
possible additional costs from prohibition of all uses of PCE (except
for petrochemical processing) due to need to switch processes or
chemicals. EPA requests comment on costs that may be incurred by firms
using PCE products to identify suitable alternatives, test them for
their desired applications, learn how to use them safely and
effectively, and implement new processes for using the alternative
products.
    EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary and second alternative regulatory actions are described in
detail in Unit IV.B. The estimated annualized costs of the primary
alternative regulatory action are $14.5 million at a 3% discount rate
and $14.7 million at a 7% discount rate over 20 years (Ref. 3). The
estimated annualized costs of the second alternative regulatory action
are $17.8 million at a 3% discount rate and $19.5 million at a 7%
discount rate over 20 years. The monetized benefits of the primary
alternative action are estimated to be $10.2 to $46.2 million
annualized over 20 years at a 3% discount rate and $4.71 million to
$29.3 million annualized over 20 years at a 7% discount rate (Ref. 3).
The monetized benefits of the second alternative action are estimated
to be $10.2 to $46.4 million annualized over 20 years at a 3% discount
rate and $4.73 million to $29.4 million annualized over 20 years at a
7% discount rate. Costs of the second alternative action do not include
possible additional costs from prohibition of non-petrochemical
processing and chemical milling uses of PCE. These costs for chemical
milling could be significant as there is no alternative to the use of
PCE in chemical milling for many users. For vapor degreasing, as
described in the Economic Analysis, EPA assumes that

there are alternatives to PCE for all users, although switching to some
of these alternatives may be very expensive due to required
revalidation and possible equipment changes. At least one user has told
EPA that they have no alternative to the use of PCE in closed-loop
vapor degreasing and at least one other user has requested a 10-year
phaseout for the use of PCE in vapor degreasing due to the needs for
revalidation and possible equipment changes throughout the supply chain
(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 PCE exposure can profoundly
impact an individual's quality of life, as discussed in Unit II.A.
(overview), III.B.2. (description of the unreasonable risk), VI.A.
(discussion of the health effects), and the 2020 Risk Evaluation for
PCE. Chronic adverse effects of PCE exposure include both cancer and
the non-cancer effects listed above. Acute effects of PCE 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 PCE 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 PCE 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 prevent unreasonable risk resulting
from exposure to PCE. The proposed regulatory action would cost $3.0
million per potential prevented cancer case while the primary
alternative regulatory action would cost $3.1 million (using the 3%
discount rate) and the second alternative regulatory action would cost
$3.8 million to achieve the same goals. At a 7% discount rate, the
proposed regulatory action would cost $3.0 million per potential
prevented cancer case while the primary alternative regulatory action
would cost $3.1 million, and the second alternative regulatory action
would cost $4.2 million to achieve the same goals. While the proposed
regulatory action is lower in cost compared to the other alternative
actions, the difference is small (Ref. 3).

VII. 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. 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 PCE 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
PCE, 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 PCE 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 3
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, 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 PCE 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 PCE in consumer products, but not in other
sectors such as automobiles, industrial

and commercial products, or aircraft, for example. 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 PCE 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 PCE 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 PCE exposure
(Ref. 6), 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 PCE 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 PCE. 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. EPA therefore concludes that TSCA is the most appropriate
regulatory authority able to prevent or reduce risks of PCE 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 PCE under the conditions of use evaluated in the
2020 TSCA Risk Evaluation for PCE 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 rule 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 rule 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 value incorporated into the WCPP and de

minimis concentration limit are derived from the analysis in the 2020
Risk Evaluation for PCE; they likewise represent decisions based on the
best available science and the weight of the scientific evidence (Refs.
10, 45, 53). The ECEL value of 0.14 ppm as an 8-hour TWA is based on
the chronic non-cancer HEC for neurotoxicity identified in the 2020
Risk Evaluation for PCE, which is the concentration at which an adult
human would be unlikely to suffer adverse effects if exposed for a
working lifetime, including susceptible subpopulations. As discussed in
Unit V.A.1., EPA used models from the 2020 Risk Evaluation for PCE to
derive the proposed de minimis concentration limit, which represents a
level below which EPA would not expect product use to drive
unreasonable risk.
    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-2016-0732).

VIII. Requests for Comment

    EPA is requesting public comment on all aspects of this proposal,
including the proposed and 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 section summarizes those specific requests for
comment.
    1. EPA is requesting public comment on all elements of the proposed
regulatory action and the alternative regulatory actions.
    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 (e.g., a WCPP)
and the primary and second alternative regulatory actions, pursuant to
the provisions of TSCA section 6(g).
    3. EPA requests comment on all elements of the IRFA, and, in
particular, the flexibilities that EPA has identified following input
from the SERs during the SBAR process.
    4. EPA requests comment on whether EPA should promulgate
definitions for the conditions of use covered by the 2020 Risk
Evaluation for PCE that would not be prohibited, and, if so, whether
the descriptions in this unit are consistent with the conditions of use
evaluated in the 2020 Risk Evaluation for PCE and whether they provide
a sufficient level of detail to improve the clarity and readability of
the regulation.
    5. EPA requests comment on the impacts, if any, a prohibition on
the processing of PCE 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.''
    6. EPA requests comment regarding the number of businesses or other
entities that could potentially close as well as associated costs with
a prohibition of PCE for certain industrial and commercial conditions
of use identified in this unit.
    7. EPA requests comment on the proposed compliance dates for
prohibitions of PCE 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.
    8. EPA requests comment on the amount of time needed, for example,
for dry cleaners to transition to an alternative process or solvent.
EPA also requests comment regarding the number of entities that could
potentially close as well as associated costs with a 10-year phaseout
of PCE for use in dry cleaning as identified in this unit.
    9. EPA requests comment on allowing a de minimis level of PCE in
products (i.e., concentrations less than 0.1% by weight) to account for
impurities.
    10. 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.
    11. EPA is requesting comment on issues around the viability of
current analytical methods and detection limits for occupational
perchloroethylene sampling and/or monitoring methods.
    12. EPA is soliciting comments regarding the timing of the initial
exposure monitoring so that it would be representative of all tasks
involving PCE where exposures may approach the ECEL. EPA is also
soliciting comments regarding use of area sampling instead of personal
breathing zone as a representative sample of exposures.
    13. EPA requests comment on the timeframes for periodic monitoring
outlined in Table 1 of this unit.
    14. 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.
    15. EPA requests comment on available methods to measure the
effectiveness of engineering and administrative controls in preventing
or reducing the potential for direct dermal contact to PCE. EPA is also
requesting comment on available monitoring methods, such as charcoal
patch testing, as feasible or effective methods to measure potential
direct dermal contact with PCE.
    16. 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.
    17. EPA is soliciting comments on the requirements proposed for
appropriate PPE selection, the effectiveness of PPE in preventing
direct dermal contact with PCE in the workplace, and general absorption
and permeation effects to PPE from direct dermal exposure. In addition,
EPA understands that some workplaces rinse and reuse PPE after minimal
use and is therefore soliciting comments on the impact on effectiveness
of rinsing and reusing certain types of PPE, either gloves or
protective clothing and gear. EPA also requests comment on the degree
to which additional guidance related to use of PPE might be
appropriate.
    18. 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.

    19. 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
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit, including establishment of a
respiratory protection program and development of an exposure control
plan. EPA also requests comment relative to the ability of owners or
operators to implement processes for occupational conditions of use
which are subject to DDCC requirements within 12 months of publication
of the final rule in the Federal Register, and anticipated timelines
for any procedural adjustments needed to comply with the requirements
outlined in this unit.
    20. EPA requests comment on whether it should incorporate in the
rule best practices to ensure proper and adequate performance of
laboratory fume hoods, such as those identified in OSHA's 29 CFR
1910.1450, Appendix A National Research Council Recommendations
Concerning Chemical Hygiene in Laboratory. Additionally, EPA requests
comment relative to the ability of owners or operators to implement
laboratory chemical fume hood and dermal PPE related requirements
within 12 months of publication of the final rule, and anticipated
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit.
    21. EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
    22. EPA requests comment on the primary alternative regulatory
action (a combination of prohibitions, requirements for a WCPP, and
prescriptive controls) and whether any elements of this primary
alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. In particular,
EPA is requesting comment on the likelihood of successful compliance
with a PCE WCPP, as described in Unit IV.A., for the conditions of use
listed for the primary alternative regulatory action of PCE WCPP in
Unit IV.B. Further, EPA is soliciting comment on prescribing specific
engineering or administrative controls that would reduce inhalation and
dermal exposures enough to address the unreasonable risk across all
workplaces engaged in a condition of use. EPA also requests comment on
any advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
    23. EPA requests comment on the ways in which PCE may be used in
the conditions of use for which the primary alternative regulatory
action would require a WCPP, including whether activities may take
place in a closed system and the degree to which users of PCE in these
sectors could successfully implement an ECEL, DDCC, and ancillary
requirements described in Unit IV.A. For the industrial and commercial
use in laboratory chemicals, EPA is soliciting comment on non-
prescriptive requirements of an ECEL and DDCC as compared to the
prescriptive workplace controls of fume hood and dermal PPE EPA is
proposing in Unit IV.A.3.
    24. Regulated entities would be required to implement an exposure
control plan within 18 months after date of publication of the final
rule in the Federal Register. EPA requests comment on any advantages or
drawbacks for the timelines outlined in this unit compared to the
timelines identified for the proposed regulatory action in Unit IV.A.
    25. EPA is soliciting comment on prescribing specific dermal PPE,
such as gloves, for each condition of use that should be considered as
EPA develops the final regulatory action. Additionally, EPA is
soliciting comment on prescribing specific respirators or APFs for
respirators for each condition of use that should be considered as EPA
develops the final regulatory action.
    26. EPA is requesting comment on specific controls that mitigate
the unreasonable risk from PCE and that could be included as part of a
prescriptive workplace controls requirement, which could be considered
as EPA develops the final regulatory action. Specifically, EPA is
soliciting comment on combinations of specific engineering controls,
administrative controls, and PPE that would reduce inhalation exposures
to at or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct
dermal contact with PCE for all workplaces where such controls would be
required. EPA also is soliciting comment on the extent to which such
requirements could reduce inhalation exposures to at or below the ECEL
of 0.014 ppm as an 8-hour TWA. Additionally, EPA is requesting comment
on the compliance timeframe needed to implement engineering controls,
administrative controls, and PPE that reduce inhalation exposures to at
or below the ECEL of 0.14 ppm as an 8-hour TWA or prevent direct dermal
contact with PCE for all regulated entities.
    27. EPA requests comment on a combination of the 1% concentration
limit for adhesives and sealants with specific engineering controls,
administrative controls, or respiratory protection that would reduce
inhalation exposures to PCE at or below the ECEL of 0.14 ppm as an 8-
hour TWA. Additionally, EPA is requesting comment on a combination of a
concentration limit with WCPP requirements. EPA also requests
monitoring data, formulations used, and detailed descriptions of PCE
involving activities for the industrial and commercial use in solvent-
based adhesives and sealants to determine whether a concentration limit
would reduce inhalation exposures such that risks are no longer
unreasonable.
    28. EPA requests comment on the second alternative regulatory
action (a combination of prohibition and a WCPP) and whether any
elements of this second alternative regulatory action described in this
unit should be considered as EPA develops the final regulatory action.
EPA also requests comment on any advantages or drawbacks for the
timelines outlined in this unit compared to the timelines identified
for the proposed regulatory action in Unit IV.A.
    29. EPA requests comments on all aspects of the section 6(g)
exemption from the prohibition on industrial and commercial use of PCE
in maskant for chemical milling as part of the second alternative
regulatory option, including information on the extent to which the
industry could meet the requirements of the proposed WCPP or
prescriptive controls and whether compliance with specific elements of
the proposed WCPP should also be required during the period of the
exemption.
    30. EPA requests comments on all aspects of the exemption request
and proposed exemption from the prohibition on use of PCE in vapor
degreasing as part of the second alternative regulatory action,
including information on the extent to which this industry could meet
the requirements of the proposed WCPP or prescriptive controls and
whether compliance with specific elements of the proposed WCPP should
also be required during the period of the exemption.
    31. EPA is requesting comment on whether to consider a regulatory
alternative that would subject more conditions of use to a WCPP,
instead of prohibition, than those currently contemplated in the
primary alternative regulatory action. EPA also requests monitoring
data and detailed descriptions of PCE involving activities for these
conditions of use to determine

whether these additional conditions of use could comply with the WCPP
such that risks are no longer unreasonable.
    32. EPA is requesting comment on whether vapor degreasing of parts
and components for non-aerospace applications should also be exempt
from prohibition as part of the second alternative regulatory action
for the industrial and commercial use of PCE in vapor degreasing. To
facilitate EPA's consideration of exemptions for other sectors,
comments in support of additional exemptions should include detailed
explanations of why and how long exemptions would be needed.
    33. EPA is soliciting comment on whether it should specify the type
of vapor degreasing operation, such as closed loop batch vapor
degreasing, that would be exempt from prohibition as part of the second
alternative regulatory action for the industrial and commercial use of
PCE in vapor degreasing for aerospace parts and whether it should
consider different exemption timeframes for different types of vapor
degreasing operations.
    34. Each owner or operator would be required to provide respiratory
protection to all potentially exposed persons in the regulated area
within 3 months after receipt of the results of any exposure monitoring
or within 6 months after date of publication of the final rule in the
Federal Register. Regulated entities would be required to implement an
exposure control plan within 9 months after date of publication of the
final rule in the Federal Register. EPA requests comment on any
advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
    35. EPA is requesting comment on the de minimis concentration limit
of PCE in products or formulations.
    36. EPA is requesting comment on the extent to which facilities
engaged in the industrial and commercial use of PCE as a processing aid
in catalyst regeneration in petrochemical manufacturing may already
meet the requirements in the proposed and alternative regulatory
actions described in Unit IV. to address the unreasonable risk and is
soliciting comment on the impact of such requirements on petroleum
refining, with special attention to the price of gasoline.
    37. EPA is requesting comment on whether preventing dermal contact
with PCE through dermal PPE and training would adequately address the
unreasonable risk from dermal exposures for the industrial and
commercial use in laboratory chemicals.
    38. EPA is requesting comment on whether to include a self-
certification requirement for purchasing PCE or PCE-containing
products.
    39. As part of the primary alternative regulatory action, EPA is
soliciting comment on prescribing specific engineering or
administrative controls that would reduce inhalation and dermal
exposures enough to address the unreasonable risk across all workplaces
engaged in a condition of use.
    40. EPA is soliciting comments on whether, for those product types
relevant to industrial, commercial, and consumer conditions of use
proposed to be prohibited or significantly restricted where EPA was
unable to identify products currently available for sale that contain
PCE, there are products in use or available for sale relevant to these
conditions of use that contain PCE 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 PCE.
    41. EPA is requesting comment on the Alternatives Assessment as a
whole.
    42. EPA requests comment on whether owners and operators should be
required to attest to whether and why the exposure controls they have
selected would not result in increased air releases of PCE from the
workplace, and keep records of that statement as part of the WCPP
exposure control plan.
    43. EPA is requesting comment on the estimated economic impacts to
the dry cleanining industry, including regarding expected closures.
    44. EPA is requesting public comment on an issue raised in its TSCA
section 9(a) Analysis (i.e., the sufficiency of an action taken under a
Federal law not administered by EPA).
    45. EPA requests comments on whether it should incorporate in the
rule voluntary consensus standards that meet specified performance
criteria for environmental monitoring or measurement and seeks
information in support of such comments regarding the availability and
applicability of voluntary consensus standards that may achieve the
sampling and analytical requirements of the rule in lieu of the
proposed approach.
    46. Following Panel report recommendations (Ref. 33) 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 PCE.
     EPA requests comment on the methodology and inputs for the
ECEL value that are directly derived from the peer reviewed analysis in
the December 2020 Risk Evaluation.
     EPA requests comment on reasonable compliance timeframes
for small businesses.
     EPA requests comment on differing compliance or reporting
requirements or timetables that account for the resources available to
small entities.
     EPA requests public comment on specific compliance
timeframes for the laundry industry.
     EPA requests comment on any additional appropriate factors
for identifying reasonable compliance timeframes and how to weigh the
factors for dry cleaning and other industries.
     EPA requests public comment about the feasibility of
entities complying with and monitoring for a potential ECEL of 0.14
ppm. Specifically, EPA aims to obtain more information on 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 about the feasibility of the
use of alternatives to PCE and their availability for conditions of use
that drive the unreasonable risk.
     EPA requests public comment on the consideration for a
TSCA section 6(g) exemption and alternative compliance timeframes for
dry cleaning, including information on whether the specific use may be
critical or essential, why alternatives may not be feasible for this
condition of use, and the ideal time limit for an exemption.

IX. 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 Perchloroethylene. EPA Document #740-R1-
8011. December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0058.

2. EPA. Final Revised Unreasonable Risk Determination for
Perchloroethylene, Section 5. December 2022.
3. EPA. Economic Analysis of the Proposed Regulation of
Perchloroethylene. RIN 2070-AK84. June 2023.
4. EPA. Access CDR Data: 2016 CDR Data (updated May 2020). Last
Updated on May 16, 2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data#2016.
5. EPA. Access CDR Data: 2020 CDR Data. Last Updated on May 16,
2022. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
6. EPA. Regulatory Actions Pertaining to Perchloroethylene. 2022.
7. OSHA. Standard Interpretations: 8-hr total weight average (TWA)
permissible exposure limit (PEL). Accessed January 13, 2023. https://www.osha.gov/laws-regs/standardinterpretations/1995-10-06-3.
8. NIOSH. Hierarchy of Controls. Page last reviewed: August 11,
2022. https://www.cdc.gov/niosh/topics/hierarchy/.
9. EPA. Perchloroethylene (PCE); Revision to Toxic Substances
Control Act (TSCA) Risk Determination; Notice of Availability.
Federal Register (87 FR 76481, December 14, 2022).
10. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational
Use of Perchloroethylene. April 15, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0023.
11. Cavalleri et al. Perchloroethylene exposure can induce colour
vision loss. Neuroscience Letters 179: 162-166. August 10, 1994.
12. Echeverria et al. A Behavioral Evaluation of PCE Exposure in
Patients and Dry Cleaners: A Possible Relationship Between Clinical
and Preclinical Effects. JOEM Vol. 37, Number 6, 667-680. June 1995.
13. AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992).
14. ACGIH. Supplement: Perchloroethylene. CAS: 127-18-4. Copyright
1996.
15. EPA. A Review of the Reference Dose and Reference Concentration
Processes. December 2002. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/88824.
16. Cal/OSHA. Hazard Risk Assessment Project for California:
Identification of Chemicals of Concern, Possible Risk Assessment
Methods, and Examples of Health Protective Occupational Air
Concentrations. December 2007. https://www.cdph.ca.gov/Programs/CCDP,HP/DEODC/OHB/HESIS/CDPH%20Document%20Library/riskreport.pdf.
17. NIOSH. Criteria for a Recommended Standard: Occupational
Exposure to Tetrachloroethylene (Perchloroethylene). Page last
reviewed: June 6, 2014. https://www.cdc.gov/niosh/docs/76-185/default.html.
18. NIOSH. NIOSH Pocket Guide to Chemical Hazards:
Tetrachloroethylene. Page last reviewed: October 30, 2019. https://www.cdc.gov/niosh/npg/npgd0599.html.
19. NIOSH. Appendix A--NIOSH Potential Occupational Carcinogens.
https://www.cdc.gov/niosh/npg/nengapdxa.html.
20. 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).
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 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
23. 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.
24. SACC. Science Advisory Committee on Chemicals Meeting Minutes
and Final Report No. 2022-01. March 15-17, 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0415-0095.
25. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
Methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
26. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for Trichloroethylene (TCE) and Perchloroethylene (PCE).
June 15, 2021 and July 8, 2021.
27. Peter Sinsheimer; Green Analytics. Comments on Environmental
Justice Consultation for TSCA PCE Risk Management of Dry Cleaning.
August 20, 2021.
28. Hans Kim; AQUA Wet Clean. Letter re: Environmental Justice
Consultation USEPA TSCA PCE Risk Management. August 20, 2021.
29. W. Heiger-Bernays and G. Nielsen. Comments on Environmental
Justice Consultation #2 for TCE and PCE. July 5, 2021.
30. Martin Arg[uuml]ello; Physicians for Social Responsibility.
USEPA EJ Consultation Meeting Comments on PCE and TCE TSCA
Regulations August 20, 2021.
31. Sa Liu; School of Health Sciences Purdue University. Letter re:
Environmental Justice Consultation on Forthcoming Proposed
Rulemakings under TSCA Section 6(a). August 20, 2021.
32. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for Trichloroethylene (TCE) and
Perchloroethylene (PCE). June 16 and July 6, 2021.
33. EPA. Final Report of the Small Business Advocacy Review Panel on
EPA's Planned Proposed Rule Toxic Substances Control Act (TSCA)
Section 6(a) Perchloroethylene. February 1, 2023.
34. EPA. Initial Regulatory Flexibility Analysis for
Perchloroethylene; Regulation of Perchloroethylene under TSCA Sec.
6(a) Proposed Rule; RIN 2070-AK84. June 2023.
35. EPA. Public Webinar on Perchloroethylene: Risk Evaluation and
Risk Management under TSCA Section 6. January 14, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0002.
36. EPA. Stakeholder Meeting List for Proposed Rulemaking for
Perchloroethylene under TSCA Section 6(a).
37. EPA. 2021 Policy on Children's Health. October 5, 2021.
38. EPA. Problem Formulation of the Risk Evaluation for
Perchloroehtylene (Ethene, 1,1,2,2-Tetrachloro). EPA Document #EPA-
740-R1-7017. May 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0732-0080.
39. EPA. Final Risk Evaluation for Perchloroethylene: Supplemental
File: Releases and Occupational Exposure Assessment. December 2020.
https://www.regulations.gov/document/EPA-HQ-OAR-2005-0155-0565.
40. EPA. Final Scope of the Risk Evaluation for 1,2-Dichloroethane.
EPA Document #EPA-740-R-20-005. August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0427-0048.
41. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.
42. OSHA. Final Rule. Occupational Exposure to Methylene Chloride.
Federal Register (62 FR 1494, January 10, 1997).
43. Tetrachloroethylene Vapor Monitor (OV-80). https://acsbadge.com/product/tetrachloroethylene-vapor-monitor-ov-80/.
44. OSHA. Recommended Practices for Safety and Health Programs.
October 2016. https://www.osha.gov/safety-management.
45. EPA. Perchloroethylene (PCE): Risk Management Support Documents.
November 18, 2022.
46. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
47. National Research Council. Prudent Practices in the Laboratory:
Handling and Management of Chemical Hazards, Updated Version. 2011.
https://www.nationalacademies.org/our-work/prudent-practices-in-the-laboratory-an-update.
48. Miria M. Finckenor; NASA. Materials for Spacecraft. 2016.
49. EPA. Meeting with The Chemours Company on Risk Management under
TSCA Section 6 and Perchloroethylene. February 23, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0008.
50. EPA. Meeting with Honeywell on Risk Management under TSCA
Section 6 and Perchloroethylene (PCE). March 25, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0018.
51. EPA. Perchloroethylene (PCE): Risk Management Support--PCE
Adhesive Use. May 24, 2023.
52. EPA. Risk Management for Perchloroethylene Supplemental File:
Occupational Risk Calculator. CASRN: 127-18-4. December 2021.

53. EPA. Risk Management for Perchloroethylene Supplemental File:
Consumer Risk Calculator. CASRN: 127-18-4. March 2021.
54. EPA. Meeting with Spirit AeroSystems on Risk Management under
TSCA Section 6 and Perchloroethylene (PCE). March 11, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0013.
55. IAMAW. Letter to EPA from International Association of
Machinists and Aerospace Workers. August 18, 2021.
56. EPA. An Alternatives Assessment for Use of Perchloroethylene RIN
2070-AK84. November 2022.
57. The Boeing Company. Comments Supporting Request for Additional
Information on Perchloroethylene (PCE); Rulemaking Under TSCA
Section 6(a) May 6, 2022.
58. The Boeing Company. Comments Supporting Request for Additional
Information on Perchloroethylene (PCE); Rulemaking Under TSCA
Section 6(a). September 23, 2022.
59. NASA. Known Uses of Perchloroethylene. Updated December 14,
2022.
60. Steve Shestag; The Boeing Company. Information on FAA
Certification. December 9, 2022.
61. EPA. Meeting with State and Local TSCA Coordination Group on
Risk Management under TSCA Section 6 for Perchloroethylene. July 11,
2022.
62. EPA. Meeting with state and local government representatives on
Risk Management under TSCA Section 6 for Perchloroethylene. June 17,
2021.
63. EPA. Meeting with Honeywell UOP on Risk Management under TSCA
Section 6 for Perchloroethylene (PCE) in Petrochemical
Manufacturing. June 9, 2021.
64. AFPM and API. Comment of the American Fuels & Petrochemical
Manufacturers and the American Petroleum Institute on Draft Revision
to Toxic Substances Control Act (TSCA) Risk Determination
Perchloroethylene. August 1, 2022. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0122.
65. AFPM. AFPM Comments on the Notice--``Problem Formulations for
the Risk Evaluations To Be Conducted for the First Chemical
Substances Under the Toxic Substances Control Act, and Application
of Systematic Review in TSCA Risk Evaluations; Extension of Comment
Period; Tetrachloroethylene (also known as perchloroethylene)''.
August 16, 2018. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0732-0108.
66. EPA. Meeting with the American Fuel and Petrochemical
Manufacturers on Risk Management under TSCA Section 6 for
Perchloroethylene. July 29, 2021.
67. NIOSH. NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH)
Publication No. 2005-149. September 2007. https://www.cdc.gov/niosh/npg/default.html.
68. HSIA. Comment letter from the Halogenated Solvents Industry
Alliance, Inc. on the draft perchloroethylene TSCA risk evaluation.
July 6, 2020. https://www.regulations.gov/comment/EPA-HQ-OPPT-2019-0502-0053.
69. EPA. Risk Evaluation for Perchloroethylene (Ethylene, 1,1,2,2-
Tetrachloro) Systematic Review Supplemental File: Data Quality
Evaluation of Environmental Releases and Occupational Exposure.
CASRN: 127-18-4. April 2020.
70. EPA. Meeting with National Cleaners Association on Risk
Management under TSCA Section 6 and Perchloroethylene (PCE). January
28, 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0006.
71. EPA. Meeting with New York State Department of Environmental
Conservation on Risk Management under TSCA Section 6 for
Perchloroethylene. June 10, 2021.
72. EPA. Perchloroethylene: Fenceline Technical Support--Water
Pathway. October 6, 2022.
73. EPA. Perchloroethylene: Fenceline Technical Support--Air
Pathway. December 8, 2022.
74. OEJECR. EPA Complaint Nos. 01R-22-R6-, 02R-22-R6, and 04R-22-R6.
October 12, 2022.
75. EPA. Exposure and Fate Assessment Screening Tool Version 2014
(E-FAST 2014). Washington, DC: Office of Pollution Prevention and
Toxics. Last updated: February 17, 2022. https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014.
76. National Water Quality Monitoring Council (NWQMC): Water Quality
Portal. 2017. https://www.waterqualitydata.us/.
77. William P.L. Carter. Development of the SAPRC-07 Chemical
Mechanism and Updated Ozone Reactivity Scales. Center for
Environmental Research and Technology, College of Engineering,
University of California. Revised January 27, 2010.
78. World Meteorological Organization. Scientific Assessment of
Ozone Depletion: 2018. Global Ozone Research and Monitoring
Project--Report No. 58. https://ozone.unep.org/sites/default/files/2019-05/SAP-2018-Assessment-report.pdf.
79. ATSDR. Toxicological Profile for Tetrachloroethylene. June 2019.
https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=265&tid=48.
80. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of
Perchloroethylene under TSCA Section 6(a). June 2023.
81. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical
Methods With Related International Voluntary Consensus Standards. J
Occup Environ Hyg. 12(7): D107-15. June 11, 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589148/.

X. 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 Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review

    This action is a ``significant regulatory action'', as defined
under section 3(f)(1) of 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 also available in the
docket and summarized in Unit VI.D.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted to OMB for review and comment 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. 2740.01 (Ref. 80). You can find
a copy of the ICR in the docket for this proposed rule, 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 PCE, who would provide notice to companies downstream upon
shipment of PCE 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, process,
use, distribute in commerce, or dispose of PCE or products containing
PCE. See also Unit I.A.
    Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
    Estimated number of respondents: 12,091.
    Frequency of response: On occasion.
    Total estimated burden: 64,622 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $7,625,325 (per year), includes $2,753,517
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. After display in the Federal
Register when approved, the OMB control numbers for certain EPA
regulations in title 40 of the 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. 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 August 15, 2023. EPA will respond to ICR-related
comments in the final rule.

C. Regulatory Flexibility Act (RFA)

    As required by section 609(b) of the RFA, EPA convened a SBAR Panel
to obtain advice and recommendations from SERs that potentially would
be subject to the rule's requirements. The SBAR Panel evaluated the
assembled materials and small-entity comments on issues related to
elements of an initial regulatory flexibility analysis (IRFA). A copy
of the full SBAR Panel Report (Ref. 33) is available in the rulemaking
docket.
    Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an IRFA (Ref. 34) 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
so that the chemical substance or mixture no longer presents such risk.
PCE was the subject of a risk evaluation under TSCA section 6(b)(4)(A)
that was issued in December 2020. In addition, in December 2022, EPA
issued a revised unreasonable risk determination that PCE as a whole
chemical substance presents an unreasonable risk of injury to health
under the conditions of use. As a result, EPA is proposing to take
action to the extent necessary so that PCE no longer presents such
risk.
2. Objectives and Legal Basis
    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in section 6(a)
to the extent necessary so that the chemical substance or mixture no
longer presents such risk. EPA has determined through a TSCA section
6(b) risk evaluation that PCE presents an unreasonable risk under the
conditions of use.
3. Description and Number of Small Entities to Which the Rule Will
Apply
    The proposed rule potentially affects small manufacturers
(including importers), processors, distributors, retailers, users of
PCE or of products containing PCE, and entities engaging in disposal.
EPA estimates that the proposal would affect approximately 12,202 small
entities. Almost half (5,949) of these entities are commercial users of
PCE in dry cleaning applications. Users of products containing PCE,
including adhesives and sealants, aerosol cleaners/degreasers, liquid
cleaners/degreasers, mold cleaners, and other products also account for
about half of the affected small entities. EPA also estimates that 69
small entities use PCE in chemical milling, 88 use PCE in recycling and
disposal, and 30 incorporate PCE into other formulations, mixtures, and
reaction products.
4. Projected Compliance Requirements
    To address the unreasonable risk EPA has identified, EPA is
proposing to: prohibit most industrial and commercial uses and the
manufacture (including import), processing and distribution in
commerce, of PCE for those uses; prohibit the manufacture (including
import), processing, and distribution in commerce of PCE for all
consumer use; prohibit the manufacture (including import), processing,
distribution in commerce, and use of PCE in dry cleaning and related
spot cleaning through a 10-year phaseout; require a PCE WCPP, which
would include requirements to meet an inhalation exposure concentration
limit and prevent direct dermal contact, for certain conditions of use
not prohibited; require prescriptive workplace controls for laboratory
use; and establish recordkeeping and downstream notification
requirements. There are an estimated 12,189 small entities affected by
the proposed option with a per firm cost of $715 with a total estimated
cost impact of $8.7 million. This includes $6.7 million for WCPP uses,
$1.9 million for uses that are prohibited, and $0.1 million for lab
uses.
    EPA is proposing to prohibit most conditions of use. For most other
conditions of use that drive the unreasonable risk determination for
PCE, EPA proposes to address the unreasonable risk with a PCE WCPP,
which would include a combination of requirements to address
unreasonable risk driven by inhalation and dermal exposures in the
workplace. A PCE WCPP would encompass restrictions on certain
occupational conditions of use and could include provisions for an
ECEL, DDCC, and ancillary requirements to support implementation of
these restrictions. Due to the low exposure level and stringent
requirements in the PCE WCPP that would be necessary to address the
unreasonable risk from PCE, EPA identified only a relatively small
number of conditions of use where the Agency expected a PCE WCPP could
be successfully implemented.
    As described in Unit IV.A., the PCE WCPP would be non-prescriptive,
in the sense that regulated entities would not be required to use
specific controls prescribed by EPA to achieve the

exposure concentration limit. Rather, it would be a performance-based
exposure limit that would enable owners or operators to determine how
to most effectively meet the exposure limit based on conditions at
their workplace.
    A central component of the PCE WCPP is the exposure limit.
Exposures remaining at or below the ECEL would address any unreasonable
risk of injury to health driven by inhalation exposures for
occupational conditions of use. EPA's proposed requirements include the
specific exposure limits that would be required to meet the TSCA
section 6(a) standard to apply one or more requirements to the
substance so that it no longer presents unreasonable risk, and also
include ancillary requirements necessary for the ECEL's successful
implementation as part of a WCPP.
    EPA is not proposing reporting requirements beyond downstream
notification (third-party notifications). Regarding recordkeeping
requirements, three primary provisions of the proposed rule relate to
recordkeeping. The first is recordkeeping of general records: all
persons who manufacture, process, distribute in commerce, or engage in
industrial or commercial use of PCE or PCE-containing products must
maintain ordinary business records, such as invoices and bills-of-
lading related to compliance with the prohibitions, restrictions, and
other provisions of the regulation.
    The second is recordkeeping related to WCPP compliance: under the
proposed regulatory action, facilities complying with the rule through
WCPP would be required to develop and maintain records associated with
ECEL exposure monitoring (including measurements, compliance with Good
Laboratory Practice Standards, and information regarding monitoring
equipment); ECEL compliance (including the exposure control plan, PPE
program implementation, and workplace information and training); DDCC
compliance (including the exposure control plan, PPE program
implementation, basis for specific PPE selection, occurrence and
duration of direct dermal contact with PCE, and workplace information
and training); and workplace participation. To support and demonstrate
compliance, EPA is proposing that each owner or operator of a workplace
subject to the WCPP retain compliance records for five years.
    EPA is also proposing to require specific prescriptive controls for
the industrial and commercial use of PCE in laboratory chemicals. To
reduce exposures in the workplace and address the unreasonable risk of
injury to health resulting from dermal exposures to PCE identified for
the industrial and commercial use as a laboratory chemical, EPA is
proposing to require dermal PPE in combination with comprehensive
training for tasks particularly related to the use of PCE in a
laboratory setting for each potentially exposed person to direct dermal
contact with PCE. Additionally, EPA is proposing to require the use of
fume hoods in workplaces engaged in the laboratory chemical condition
of use. To support and demonstrate compliance, EPA is proposing that
each owner or operator of a laboratory workplace subject to the
workplace controls for laboratory use requirements retain compliance
records for five years.
a. Classes of Small Entities Subject to the Compliance Requirements
    The small entities that would be potentially directly regulated by
this rulemaking are small entities that manufacture (including import),
process, distribute in commerce, use, or dispose of PCE, including
retailers of PCE for end-consumer uses.
b. Professional Skills Needed To Comply
    Entities that would be subject to this proposal that manufacture
(including import), process, or distribute PCE in commerce for consumer
use would be required to cease under the proposed rule. The entity
would be required to modify their SDS or develop another way to inform
their customers of the prohibition on manufacture, processing, and
distribution of PCE for consumer use. They would also be required to
maintain ordinary business records, such as invoices and bills-of-
lading, that demonstrate compliance with the prohibitions,
restrictions, and other provisions of this proposed regulation. These
are all routine business tasks that do not require specialized skills
or training.
    Entities that use PCE in any industrial and commercial capacity
that is prohibited would be required to cease under the proposed rule.
Restriction or prohibition of these uses will likely require the
implementation of an alternative chemical or the cessation of use of
PCE in a process or equipment that may require persons with specialized
skills, such as engineers or other technical experts. Instead of
developing an alternative method themselves, commercial users of PCE
may choose to contract with another entity to do so.
    Entities that would be permitted to continue to manufacture,
process, distribute, use (with the exception for use as a laboratory
chemical), or dispose of PCE would be required to implement a WCPP and
would have to meet the provisions of the program for continued use of
PCE. Entities that would be permitted to continue use of PCE as a
laboratory chemical would be required to implement prescriptive
workplace controls for laboratory use and would have to meet the
provisions of the workplace restrictions for continued use of PCE. A
transition to a WCPP or prescriptive workplace controls for laboratory
use may require persons with specialized skills such as an engineer or
health and safety professional. Instead of implementing the WCPP or
workplace controls for laboratory use themselves, entities that use PCE
may choose to contract with another entity to do so. Records would have
to be maintained for compliance with a WCPP or workplace controls for
laboratory use, as applicable. While this recording activity itself may
not require a special skill, the information to be measured and
recorded may require persons with specialized skills such as an
industrial hygienist.
5. Relevant Federal Rules
    Because of its health effects, PCE is subject to numerous state,
Federal, and international regulations restricting and regulating its
use. The following is a summary of the regulatory actions pertaining to
PCE; for a full description see appendix A of the 2020 Risk Evaluation
for PCE and the summary in the docket (Ref. 6).
    EPA has issued numerous rules and notices pertaining to PCE under
its various authorities. PCE is a hazardous air pollutant under the CAA
(42 U.S.C. 7412(b)(1)). EPA promulgated NESHAP for a number of source-
specific categories that emit PCE, including dry cleaning (40 CFR part
63, subpart M) and halogenated solvent cleaning (40 CFR part 63,
subpart T).
    With this proposed rule under TSCA section 6, certain uses and
emissions already regulated under these NESHAP would be prohibited
while other uses would be subject to a WCPP.
    Programs within EPA implementing other environmental statutes,
including, but not limited to, the RCRA, the Comprehensive
Environmental Response, Compensation, and Liability Act, the Safe
Drinking Water Act, and the CWA, classify PCE as a characteristic and
listed hazardous waste (40 CFR 261.24, 40 CFR 261.31, 40 CFR 261.33), a
hazardous substance (40 CFR 302.4), a contaminant subject to National
Primary Drinking Water Regulations (40 CFR 141.61), and a toxic
pollutant (40 CFR 401.15, 40 CFR part 423, appendix A, 40 CFR 131.36)
or the

program requires reportable criteria of releases into the environment
involving PCE. While TSCA shares equity in the regulation of PCE, EPA
does not anticipate this rulemaking to duplicate nor conflict with the
aforementioned programs' classifications and associated rules.
    In addition to EPA actions, PCE is also subject to other Federal
regulations. Under the OSH Act, OSHA established the PEL for PCE at 100
ppm 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 8-hour shift of 300 ppm, maximum duration of 5
minutes in any 3 hours. However, EPA recognizes that the existing PEL
does not eliminate the unreasonable risk identified by EPA under TSCA,
and EPA is therefore proposing to apply new, lower exposure thresholds,
derived from the TSCA 2020 Risk Evaluation for PCE, while aligning with
existing OSHA requirements where possible. For PCE, this approach would
eliminate the unreasonable risk driven by certain conditions of use,
reduce burden for complying with the regulations, and provide the
familiarity of a pre-existing framework for the regulated community.
    Under the FHSA, visual novelty devices containing PCE are regulated
by the CPSC (16 CFR 1500.83(a)(31)). Under the FFDCA, the Food and Drug
Administration regulates PCE in bottled water and set the maximum
permissible level of PCE in bottled water to 0.005 mg/L (21 CFR
165.110). Under the Atomic Energy Act, the Department of Energy Worker
Safety and Health Program requires its contractor employees to use the
2005 ACGIH TLV for PCE, which is 25 ppm (8-hour TWA) and 100 ppm Short
Term Exposure Limit. Under the Federal Hazardous Material
Transportation Act, the Department of Transportation has designated PCE
as a hazardous material, and there are special requirements for
marking, labeling, and transporting it (49 CFR part 171, 49 CFR part
172, 40 CFR 173.202, and 40 CFR 173.242).
6. Significant Alternatives to the Proposed Rule
    EPA analyzed alternative regulatory approaches to identify which
would be feasible, reduce burden to small businesses, and achieve the
objective of the statute (i.e., applying one or more requirements
listed in TSCA section 6(a) to the extent necessary so that the
chemical substance or mixture no longer presents an unreasonable risk).
As described in more detail in Unit V., EPA considered several factors,
in addition to identified unreasonable risk, when selecting among
possible TSCA section 6(a) requirements. To the extent practicable, EPA
factored into its decisions: the effects of PCE on health and the
environment, the magnitude of exposure to PCE of human beings and the
environment, the benefits of PCE for various uses, and the reasonably
ascertainable economic consequences of the proposed rule. EPA also
considered input provided by the SERs in selecting among possible TSCA
section 6(a) requirements as part of the proposed regulatory action and
alternative regulatory actions, particularly as it related to dry
cleaners' compliance timeframes. Overall, EPA expects few dry cleaning
facility closures because EPA estimates that only about 60 PCE machines
are expected to be in use at the end of the proposed phaseout period,
based on SER input and given the age of the machines and the declining
trend of use. Additionally, as s part of this analysis, EPA
considered--in addition to prohibition, WCPP, and prescriptive controls
described earlier--a wide variety of control measures to address the
unreasonable risk from PCE such as weight fractions and a point-of-sale
self-certification requirement. EPA's analysis of these risk management
approaches is detailed in Unit V.A.3. In general, EPA determined that
these approaches alone would either not be able to address the
unreasonable risk, or, in the case of a weight fraction limit, would
result in a product containing so little PCE that it would have the
effect of a prohibition.
    Weight Fractions: As discussed in Unit V.A.3., EPA considered
limiting the weight fraction of PCE in industrial/commercial and
consumer products and conducted an analysis to estimate to what extent
this would reduce risks from conditions of use that drive the
unreasonable risk for PCE. EPA determined that the unreasonable risk
from PCE would not be driven by use of products containing PCE at less
than 0.1% by weight. Therefore, EPA is proposing a de minimis level for
products containing PCE at levels of less than 0.1% to account for
impurities that do not drive the unreasonable risk., as described in
Unit IV.A.1.d. For most industrial/commercial and consumer conditions
of use, the weight fraction or concentration identified through this
modeling that would address the unreasonable risk through inhalation or
dermal pathways was so low that it was highly unlikely that PCE would
still serve its functional purpose in the formulation. EPA thus
concluded that a weight fraction limit would essentially function as a
prohibition yet with a greater amount of uncertainty regarding
compliance and no increased benefit to users; it was therefore not a
preferred option. For the industrial and commercial use in solvent-
based adhesives and sealants, EPA identified several products available
on the market at concentrations of PCE between 0.1% and 1% by weight in
the 2020 Risk Evaluation for PCE. As part of the primary alternative
regulatory action, EPA would set a concentration limit of PCE in
adhesive and sealant products for industrial and commercial use to 1%,
as described in Unit IV.B.1.c.
    Point-of-sale self-certification: As discussed in Unit V.A.3., EPA
also examined the extent to which a point-of-sale self-certification
requirement in order to purchase and subsequently use PCE would further
ensure that only facilities able to implement and comply with a WCPP or
prescriptive controls are able to purchase and use PCE, and self-
certify to that. Under a self-certification requirement, entities would
submit a self-certification to the distributor or retailer each time
PCE is purchased. The self-certification would consist of a statement
indicating that the facility is implementing a WCPP or required
prescriptive controls to control exposures to PCE; the self-
certification would be signed and presented by a person authorized to
do so by the facility owner or operator. Copies of the self-
certification would be maintained as records by both the owner or
operator and the distributor or retailer where PCE was purchased.
However, because of the number and types of entities where users can
obtain PCE or PCE-containing products, EPA does not believe the added
requirement and subsequent burden of a point-of-sale self-certification
requirement for the use of PCE would be an effective tool for
preventing facilities that may be unable to comply with the WCPP or
prescriptive controls of this proposed rulemaking from accessing PCE or
PCE-containing products. As such, EPA is not proposing a self-
certification requirement as an additional component of the
requirements for addressing the unreasonable risk of occupational
exposures to PCE.
    Prescriptive controls: As discussed in Unit V.A.1., EPA considered
prescriptive controls (i.e., engineering or administrative controls, or
PPE) and has determined that prescriptive controls may not be able to
eliminate unreasonable risk for some conditions of use when used in
isolation. In the 2020 Risk Evaluation for PCE, analysis of
occupational exposure scenarios (OES) indicated that many conditions of
use

still posed risk concerns even with the application of respirators with
APF 25 or 50. Because of the uncertainty regarding the feasibility of
exposure reductions through engineering controls alone, EPA determined
that a PCE WCPP ECEL, which would be accompanied by monitoring
requirements in tandem with the implementation of engineering controls,
administrative controls, and/or PPE as elements of the program, as
appropriate, would more successfully reduce exposure so that the
unreasonable risk is addressed. Additionally, relying primarily on
respirators and gloves to reduce exposures does not consider other more
protective controls in the hierarchy, including elimination,
substitution, engineering controls, and administrative controls. For
occupational conditions of use where compliance with the PCE WCPP ECEL
and DDCC is unlikely to be successful, in most cases prohibitions
(rather than prescribed controls) would be more appropriate to ensure
that PCE does not present unreasonable risk under the conditions of
use. EPA is proposing prescriptive workplace controls for laboratory
use to codify assumptions made in the 2020 Risk Evaluation for PCE
regarding the use of fume hoods in laboratory settings and because EPA
has preliminarily determined that chemically resistant gloves in
combination with specific activity training for tasks where dermal
exposure can be expected to occur in laboratory settings would address
the unreasonable risk resulting from dermal exposures. Additionally, as
part of the primary alternative regulatory action, EPA includes certain
prescriptive controls (PPE in combination with monitoring, regulated
area, and training) for conditions of use for which EPA is proposing
WCPP as the regulatory action.
    As indicated by this overview, and detailed in Unit V.A, in the
review of alternatives, EPA determined that some methods either did not
effectively eliminate the unreasonable risk presented by PCE or, for
many conditions of use, there was a high degree of uncertainty
regarding whether compliance with a comprehensive WCPP or prescriptive
controls would be possible to adequately protect potentially exposed
persons. The primary alternative regulatory action and second
regulatory action were considered and found to provide greater
uncertainty in addressing the unreasonable risk from PCE under the
conditions of use, resulting in EPA's proposed action. Information on
the costs and benefits of the proposed and alternative regulatory
actions is available in Chapters 7 and 8 of the Economic Analysis
Analysis and analysis on small entity impacts is in Chapter 10 of the
Economic Analysis.
    EPA considered its authority under TSCA section 6(g) to grant a
time-limited exemption for conditions of use where compliance with a
requirement would significantly disrupt the national economy, national
security, or infrastructure. As described in Units IV.B.2.b. and
V.A.2., based on reasonably available information, EPA analyzed the
need for an exemption and has found that a TSCA section 6(g) exemption
may be warranted under the second alternative regulatory action for the
industrial and commercial use in maskant for chemical milling and for
the industrial and commercial use in vapor degreasing if the workplaces
engaged in those conditions of use cannot meet the requirements of the
proposed regulatory action (PCE WCPP) or primary alternative regulatory
action (prescriptive controls) such that those conditions of use would
no longer drive the unreasonable risk. A section 6(g) exemption may
mean that the unreasonable risk will not be fully addressed.
    As required under TSCA section 6(c)(2)(C) and detailed in Unit
V.B., EPA also considered 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 the Economic Analysis (Ref. 3), EPA conducted an
Alternatives Assessment, using reasonably available information (Ref.
56). For this assessment, EPA identified and analyzed alternatives to
PCE in products relevant to industrial, commercial, and consumer
conditions of use. Based on reasonably available information, including
information submitted by industry, EPA understands viable alternatives
to PCE may not be available for several conditions of use--for example,
the industrial and commercial use in vapor degreasing for certain
applications (Refs. 57, 58)--and considered that information to the
extent practicable in the development of the regulatory options.
    Regarding timeframes for compliance, as described in Unit IV.A.1,
2, and 3, the proposed compliance dates incorporate EPA's consideration
of sustained awareness of risks resulting from PCE exposure as well as
precedent established by the OSHA standards (62 FR 1494, January 10,
1997). TSCA requires that EPA propose timeframes that are ``as soon as
practicable'' under TSCA section 6(d)(1)(B) and 6(d)(1)(D). TSCA
section 6(d)(1)(C) also requires that EPA specify mandatory compliance
dates for the start of ban or phase-out requirements ``as soon as
practicable'' but not later than five years after the promulgation date
of a rule. In developing the proposed compliance timeframes, including
for the prohibition and phaseout of PCE in dry cleaning as outlined in
Unit IV.A.1.c., EPA considered reasonably available information. EPA
has no information indicating that the proposed compliance dates are
not practicable for the activities that would be prohibited, or that
additional time is needed for products affected by the proposed
restrictions to clear the channels of trade. As noted earlier, EPA is
seeking public comment on whether additional time is needed for
compliance with prohibitions, for products to clear the channels of
trade, or for implementing a WCPP or prescriptive controls. EPA may
finalize shorter or longer compliance timeframes based on public
comment. Regarding potential regulatory flexibilities for compliance
dates and timeframes, EPA notes that the primary alternative regulatory
action would include longer compliance timeframes for prohibitions.
Given the potential severity of impacts from exposure to PCE, EPA's
proposed regulatory action and second alternative regulatory action
would include relatively rapid compliance timeframes. However, it is
possible that longer timeframes would be needed for entities to come
into compliance; therefore, the primary alternative regulatory action
described in the proposed rule would include longer timeframes for
implementation than the proposed regulatory action. These timeframes
are detailed in Unit IV. Information on the estimated costs of the
shorter and longer timeframes for the dry cleaning phaseout are in
Chapter 7.7.3 of the Economic Analysis.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action would
affect entities that use PCE. It is not expected to affect State,
local, or Tribal governments because the use of PCE by government
entities is minimal. This action is not expected to result in
expenditures by State, local, and Tribal governments, in the

aggregate, or by the private sector, of $100 million or more (when
adjusted annually for inflation) in any 1 year. Accordingly, this
action is not subject to the requirements of sections 202, 203, or 205
of UMRA.

E. Executive Order 13132: Federalism

    EPA has concluded that this action has federalism implications as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulations under TSCA section 6(a) may preempt State law. As
set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA
section 6(a) to address the unreasonable risk presented by a chemical
substance has the potential to trigger preemption of laws, criminal
penalties, or administrative actions by a State or political
subdivision of a State that are: (1) Applicable to the same chemical
substance as the rule under TSCA section 6(a); and (2) Designed to
prohibit or otherwise restrict the manufacture, processing, or
distribution in commerce or use of that same chemical. TSCA section
18(c)(3) applies that preemption only to the ``hazards, exposures,
risks, and uses or conditions of use'' of such chemical included in the
final TSCA section 6(a) rule.
    EPA provides the following preliminary federalism summary impact
statement. The Agency consulted with State and local officials early in
the process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included
background presentation on September 9, 2020, and a consultation
meeting on July 22, 2021. EPA invited the following national
organizations representing State and local elected officials to these
meetings: American Water Works Association, Association of Clean Water
Administrators, Association of Metropolitan Water Agencies, Association
of State Drinking Water Administrators, Environmental Council of the
States, National Association of Counties, National Conference of State
Legislatures, National Governors Association, National League of
Cities, National Water Resources Association, and United States
Conference of Mayors. During the consultation, stakeholders in
attendance asked about the differences between PCE and TCE, recommended
additional reporting requirements as a risk management tool to address
the unreasonable risk, suggested EPA look into safer alternatives, and
described concerns related to current impacts on drinking water
utilities from PCE (Ref. 25). A summary of the meeting with these
organizations, including the views that they expressed, is available in
the docket (Ref. 25). EPA provided an opportunity for these
organizations to provide follow-up comments in writing but did not
receive any such comments.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. This rulemaking would not have
substantial direct effects on Tribal governments because PCE is not
manufactured, processed, or distributed in commerce by Tribes. PCE is
not regulated by Tribes, and this rulemaking would not impose
substantial direct compliance costs on Tribal governments. Thus,
Executive Order 13175 does not apply to this action.
    Consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, EPA consulted with Tribal officials during the
development of this action. The Agency held a Tribal consultation from
May 17, 2021, to August 20, 2021, with meetings on June 15, 2021, and
July 8, 2021. Tribal officials were given the opportunity to
meaningfully interact with EPA risk managers concerning the current
status of risk management. During the consultation, EPA discussed risk
management under TSCA section 6(a), findings from the 2020 Risk
Evaluation for PCE, types of information to inform risk management,
principles for transparency during risk management, and types of
information EPA is seeking from Tribes (Ref. 26). EPA briefed Tribal
officials on the Agency's risk management considerations and encouraged
Tribal officials to provide additional comments after the
teleconferences. Tribal officials raised no related issues or concerns
to EPA during or in follow-up to those meetings (Ref. 26).

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866, and because EPA does not
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children as reflected by the
conclusions of the PCE risk evaluation. This action's health and risk
assessments are contained in Unit III.A.3, III.B.2, VI.A. and B., and
the 2020 Risk Evaluation for PCE and the Economic Analysis for this
proposed rulemaking (Refs. 1 and 3).

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not been designated by the Administrator of the Office
of Information and Regulatory Affairs as a significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

    Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for occupational inhalation exposures to PCE.
Consistent with the Agency's Performance Based Measurement System
(PBMS), the Agency proposes not to require the use of specific,
prescribed analytic methods. Rather, the Agency plans to allow the use
of any method that meets the prescribed performance criteria. The PBMS
approach is intended to be more flexible and cost-effective for the
regulated community; it is also intended to encourage innovation in
analytical technology and improved data quality. EPA is not precluding
the use of any method, whether it constitutes a voluntary consensus
standard or not, as long as it meets the performance criteria
specified.
    For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately detect and measure airborne concentrations of
PCE at the ECEL and the ECEL action level. Some examples of methods
which meet the criteria are included in appendix B of the ECEL memo
(Ref. 10). EPA recognizes that there may be voluntary consensus
standards that meet the proposed criteria (Ref. 81). EPA requests
comments on whether it should incorporate such voluntary consensus
standards in the rule and seeks information in support of such comments
regarding the availability and applicability of voluntary consensus
standards that may achieve the sampling and analytical requirements of
the rule in lieu of the PBMS approach.

J. Executive Orders 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make EJ part of their mission by identifying and addressing, as
appropriate, disproportionately high and adverse human health or
environmental effects of their programs, policies, and activities on
minority populations (people of color and/or indigenous peoples) and
low-income populations.
    EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations and/or
indigenous peoples. As described more fully in the Economic Analysis,
EPA conducted an analysis to characterize the baseline conditions faced
by communities and workers affected by the regulation to identify the
potential for disproportionate impacts on minority and low-income
populations. The baseline characterization suggests that workers in
affected industries and regions, as well as residents of nearby
communities, are more likely to be people of color than the general
population in affected states, although this varied by use assessed.
Additionally, based on reasonably available information, the Agency
understands that most dry cleaning workers are members of minority
populations.
    EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on people of color, low-income
populations and/or Indigenous peoples. While the regulatory options are
anticipated to address the unreasonable risk from exposure to PCE to
the extent necessary so that it is no longer unreasonable, EPA is not
able to quantify the distribution of the change in risk across affected
workers, communities, or demographic groups. EPA is also unable to
quantify the changes in risks to workers, communities, and demographic
groups from non-PCE-using technologies or practices that firms may
adopt in response to the regulation to determine whether any such
changes could pose EJ concerns. Data limitations that prevent EPA from
conducting a more comprehensive analysis are summarized in the Economic
Analysis (Ref. 3).
    EPA additionally identified and addressed EJ concerns by conducting
outreach to advocates of communities that might be subject to
disproportionate exposure to PCE, such as minority populations, low-
income populations and indigenous peoples. On June 16, 2021, and July
6, 2021, EPA held public meetings as part of this consultation (Ref.
32). See also Unit III.A.1. These meetings were held pursuant to and in
compliance with Executive Order 12898 and Executive Order 14008,
entitled ``Tackling the Climate Crisis at Home and Abroad'' (86 FR
7619, February 1, 2021).
    Following the EJ meetings, EPA received five written comments, in
addition to oral comments provided during the consultations. In
general, commenters supported strong outreach to affected communities,
encouraged EPA to follow the hierarchy of controls, favored
prohibitions, and noted the uncertainty, and in some cases inadequacy,
of PPE. Commenters also urged the EPA to extend the rulemaking into
ongoing releases from hazardous waste and disposal sites, in particular
vapor intrusion of PCE from contaminated groundwater, soil, and indoor
air. Additionally, commenters expressed concern that the adverse health
impacts of PCE dry cleaning fall disproportionately to owners and
employees of minority owned small businesses, noted the viability of
professional wet cleaning as an alternative to PCE dry cleaning, and
urged EPA to consider economic impacts and a financial program to
offset transition costs to local communities.
    The information supporting the review under Executive Order 12898
is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic
Analysis (Ref. 3). EPA's presentations and fact sheets for the EJ
consultations related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of
the consultation are also available in the public docket for this
rulemaking (Ref. 32).

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping.

Michael S. Regan,
Administrator.

    Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 751 as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4)

0
2. Amend Sec.  751.5 by adding in alphabetical order definitions for
``Authorized person'', ``Direct dermal contact'', ``ECEL'', ``Exposure
group'', ``Owner or operator'', ``Potentially exposed person'',
``Regulated area'', and ``Retailer'' to read as follows:

Sec.  751.5  Definitions.

* * * * *
    Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
* * * * *
    Direct dermal contact means direct handling of a chemical substance
or mixture or skin contact with surfaces that may be contaminated with
a chemical substance or mixture.
    ECEL is an Existing Chemical Exposure Limit and means an airborne
concentration generally calculated as an eight (8)-hour time-weighted
average (TWA).
* * * * *
    Exposure group means a group consisting of every person performing
the same or substantially similar operations in each work shift, in
each job classification, in each work area where exposure to chemical
substances or mixtures is reasonably likely to occur.
    Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
* * * * *
    Potentially exposed person means any person who may be
occupationally exposed to a chemical substance or mixture in a
workplace as a result of a condition of use of that chemical substance
or mixture.
    Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the ECEL or the EPA Short-Term Exposure Limit (STEL).
    Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or

distribution. Any distributor with at least one consumer end user
customer is considered a retailer. A person who distributes in commerce
or makes available a chemical substance or mixture solely to commercial
or industrial end users or solely to commercial or industrial
businesses is not considered a retailer.
0
3. Add subpart G to read as follows:
Subpart G--Perchloroethylene
Sec.
751.601 General.
751.603 Definitions.
751.605 Prohibitions of manufacturing, processing, distribution in
commerce, and use.
751.607 Workplace Chemical Protection Program.
751.609 Workplace requirements for laboratory use.
751.611 Downstream notification.
751.613 Recordkeeping requirements.
751.615 Exemptions.

Subpart G--Perchloroethylene

Sec.  751.601  General.

    This subpart establishes prohibitions and restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of perchloroethylene (CASRN 127-18-4), also known as
tetrachloroethylene, to prevent unreasonable risk of injury to health
in accordance with TSCA section 6(a).

Sec.  751.603  Definitions.

    The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
    Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec.  751.611 and 751.613.
    ECEL action level means a concentration of airborne
perchloroethylene of 0.07 part per million (ppm) calculated as an eight
(8)-hour time-weighted average (TWA).
    3rd generation machine means a dry-to-dry machine with a
refrigerated condenser, as those terms are defined in 40 CFR part 63,
subpart M.
    4th or 5th generation machine means a dry-to-dry machine with a
carbon adsorber and refrigerated condenser, as those terms are defined
in 40 CFR part 63, subpart M.

Sec.  751.605  Prohibitions of manufacturing, processing, distribution
in commerce, and use.

    (a) Applicability. The provisions of this section apply to the
following uses as indicated in each paragraph of this section:
    (1) All consumer use, excluding use of clothing and articles that
have been commercially dry cleaned with perchloroethylene.
    (2) Processing into formulation, mixture or reaction product in
other chemical products and preparations.
    (3) Dry cleaning use, including:
    (i) Industrial and commercial use in dry cleaning and related spot
cleaning in 3rd generation machines; and
    (ii) Industrial and commercial use in dry cleaning and related spot
cleaning in 4th and 5th generation machines.
    (4) All other industrial and commercial use, except for the
following:
    (i) Those industrial and commercial uses presented in Sec.
751.607(a);
    (ii) Laboratory use as described in Sec.  751.609(a); and
    (iii) Any industrial and commercial use of clothing and articles
that have been commercially dry cleaned with perchloroethylene.
    (5) Distribution in commerce.
    (b) Prohibitions. (1) After [DATE 12 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are
prohibited from manufacturing (including importing) perchloroethylene
for the uses listed in paragraphs (a)(1), (2) and (4) of this section.
    (2) After [DATE 15 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
processing perchloroethylene, including any perchloroethylene-
containing products, for the uses listed in paragraphs (a)(1), (2) and
(4) of this section.
    (3) After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products,
to retailers for any use, other than commercial dry cleaning or
consumer use of clothing and articles that have been commercially dry
cleaned with perchloroethylene.
    (4) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all retailers are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products.
Distribution in commerce by retailers of clothing and articles that
have been commercially dry cleaned with perchloroethylene is not
subject to the prohibitions described in this paragraph.
    (5) After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available)
perchloroethylene, including any perchloroethylene-containing products,
for the uses described in paragraphs (a)(1) and (4) of this section.
    (6) After [DATE 24 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from
industrial or commercial use of perchloroethylene, including any
perchloroethylene-containing products, for the uses listed in paragraph
(a)(4) of this section.
    (7) All persons are prohibited from industrial or commercial use of
perchloroethylene in dry cleaning machines acquired after [DATE 6
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER].
    (8) After [DATE 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE
IN THE FEDERAL REGISTER], all persons are prohibited from industrial or
commercial use of perchloroethylene for the use listed in paragraph
(a)(3)(i) of this section.
    (9) After [DATE 10 YEARS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], all persons are prohibited from the
manufacturing (including importing), processing, distribution in
commerce, or industrial or commercial use of perchloroethylene for dry
cleaning and spot cleaning, including for the use listed in paragraph
(a)(3)(ii) of this section.
    (c) De minimis level. Products containing perchloroethylene at
levels less than 0.1 percent by weight are not subject to the
prohibitions described in paragraph (b) of this section.

Sec.  751.607  Workplace chemical protection program.

    (a) Applicability. The provisions of this section apply to
workplaces engaged in the following conditions of use of
perchloroethylene, unless otherwise indicated in this section, except
to the extent the conditions of use are prohibited by Sec.  751.605:
    (1) Manufacturing (domestic manufacture);
    (2) Manufacturing (import);
    (3) Processing as a reactant/intermediate;
    (4) Processing into formulation, mixture or reaction product in
paint and coating products;

    (5) Processing into formulation, mixture or reaction product in
cleaning and degreasing products;
    (6) Processing into formulation, mixture or reaction product in
adhesive and sealant products
    (7) Repackaging;
    (8) Industrial and commercial use as solvent for open-top batch
vapor degreasing;
    (9) Industrial and commercial use as solvent for closed-loop batch
vapor degreasing;
    (10) Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
    (11) Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
    (12) Industrial and commercial use in maskant for chemical milling;
    (13) Industrial and commercial use in solvent-based adhesives and
sealants;
    (14) Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing;
    (15) Recycling; and
    (16) Disposal.
    (b) Existing chemical exposure limit (ECEL)--(1) Applicability. The
provisions of this paragraph (b) apply to any workplace engaged in a
condition of use that is listed in paragraphs (a)(1) through (14) of
this section and not prohibited by Sec.  751.605.
    (2) Eight-hour time-weighted average (TWA) ECEL. Beginning [DATE 9
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], or beginning 4 months after introduction of
perchloroethylene into the workplace if perchloroethylene use commences
after [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER], the owner or operator must ensure that no person is
exposed to an airborne concentration of perchloroethylene in excess of
0.14 parts of perchloroethylene per million parts of air (0.14 ppm) as
an eight (8)-hour TWA, in accordance with the requirements of paragraph
(d)(1)(i) of this section and, if necessary, paragraph (f) of this
section.
    (3) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure by either:
    (1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
    (2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each person whose exposure must be
monitored.
    (B) Representative 8-hour TWA exposures must be determined on the
basis of one or more full-shift exposure of at least one person that
represents, and does not underestimate, the potential exposure of every
person in each exposure group and that represents the highest
perchlorethylene exposures likely to occur under reasonably foreseeable
conditions of use.
    (C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good
Laboratory Practice Standards in 40 CFR part 792.
    (D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of perchloroethylene.
    (E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect or air monitoring equipment malfunction, unless an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist reviews the monitoring results and determines re-monitoring
is not necessary.
    (ii) Initial monitoring. (A) Each owner or operator who has a
workplace or work operation covered by this section, except as provided
for in paragraph (b)(3)(ii)(B) of this section, must perform initial
monitoring of potentially exposed persons regularly working in areas
where perchloroethylene is present.
    (B) The initial monitoring required in paragraph (b)(3)(ii)(A) of
this section must be completed by [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or within 30
days of introduction of perchloroethylene into the workplace, whichever
is later. Where the owner or operator has monitoring within five years
prior to [the effective date of the final rule] and the monitoring
satisfies all other requirements of this section, the owner or operator
may rely on such earlier monitoring results to satisfy the requirements
of paragraph (b)(3)(ii)(A) of this section.
    (iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
perchloroethylene in accordance with table 1 to this paragraph
(b)(3)(iii).

 Table 1 to Sec.   751.607(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
      Air concentration condition        Periodic monitoring requirement
------------------------------------------------------------------------
If all initial exposure monitoring is    Periodic exposure monitoring is
 below ECEL action level.                 required at least once every
(<0.07 ppm 8-hour TWA).................   five years.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is      required within 3 months of
 above the ECEL (>0.14 ppm 8-hour TWA).   the most recent exposure
                                          monitoring.
If the most recent exposure monitoring   Periodic exposure monitoring is
 indicates that airborne exposure is at   required within 6 months of
 or above the ECEL action level but at    the most recent exposure
 or below the ECEL (>=0.07 ppm 8-hour     monitoring.
 TWA, <=0.14 ppm 8-hour TWA).
If the two most recent (non-initial)     Periodic exposure monitoring is
 exposure monitoring measurements,        required within 5 years of the
 taken at least seven days apart within   most recent exposure
 a 6 month period, indicate exposure is   monitoring.
 below the ECEL action level (<0.07 ppm
 8-hour TWA).
If the owner or operator engages in a    The owner or operator may forgo
 condition of use for which WCPP ECEL     the next periodic monitoring
 is required but does not manufacture,    event. However, documentation
 process, use, or dispose of              of cessation of use of
 perchlorethylene in that condition of    perchlorethylene is required;
 use over the entirety of time since      and periodic monitoring would
 the last required monitoring event.      be required when the owner or
                                          operator resumes the condition
                                          of use.
------------------------------------------------------------------------

    (iv) Additional monitoring. (A) The owner or operator must conduct
additional initial exposure monitoring whenever there has been a change
in the production, process, control equipment, personnel or work
practices that may reasonably be expected to result in new or
additional exposures above the ECEL action level or when the owner or
operator has any reason to believe that new or additional exposures
above the ECEL action level have occurred.
    (B) Whenever start-ups, shutdown, spills, leaks, ruptures or other
breakdowns occur that may lead to

exposure to potentially exposed persons, the owner or operator must
conduct additional initial exposure monitoring (using personal
breathing zone sampling) after the cleanup of the spill or repair of
the leak, rupture or other breakdown.
    (v) Notification of monitoring results. (A) The owner or operator
must inform persons whose exposures are represented by the monitoring
of the monitoring results within 15 working days.
    (B) This notification must include the following:
    (1) Exposure monitoring results;
    (2) Identification and explanation of the ECEL and ECEL action
level in plain language;
    (3) Explanation of any corresponding required respiratory
protection as described in paragraph (f) of this section;
    (4) Descriptions of actions taken by the regulated entity to reduce
exposure to or below the ECEL;
    (5) Quantity of perchloroethylene in use;
    (6) Location of perchloroethylene use;
    (7) Manner of perchloroethylene use;
    (8) Identified releases of perchloroethylene; and
    (9) Whether the airborne concentration of perchloroethylene exceeds
the ECEL limit.
    (C) Notice must be provided in plain language writing, in a
language that the person understands, to each potentially exposed
person or posted in an appropriate and accessible location outside the
regulated area with an English-language version and a non-English
language version representing the language of the largest group of
workers who do not read English.
    (4) Regulated areas. (i) Beginning [DATE 9 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or beginning 4
months after introduction of perchloroethylene into the workplace if
perchloroethylene use commences after [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], the owner or
operator must establish and maintain a regulated area wherever any
person's exposure to airborne concentrations of perchloroethylene
exceeds or can reasonably be expected to exceed the ECEL.
    (ii) The owner or operator must limit access to regulated areas to
authorized persons.
    (iii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the area and minimizes the number
of authorized persons exposed to perchloroethylene within the regulated
area.
    (iv) The owner or operator must supply a respirator that complies
with the requirements of paragraph (f) of this section and must ensure
that all persons within the regulated area are using the provided
respirators whenever perchloroethylene exposures may exceed the ECEL.
    (v) An owner or operator who has implemented all feasible
engineering, work practice and administrative controls as required in
paragraph (d)(1)(i) of this section, and who has established a
regulated area as required by paragraph (b)(4)(i) of this section where
perchloroethylene exposure can be reliably predicted to exceed the ECEL
only on certain days (for example, because of work or process schedule)
must have persons use respirators in that regulated area on those days.
    (vi) The owner or operator must ensure that, within a regulated
area, persons do not engage in non-work activities which may increase
perchloroethylene exposure.
    (vii) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities which interfere with respirator seal or performance.
    (c) Direct dermal contact controls. (1) The provisions of this
paragraph (c) apply to any workplace engaged in the conditions of use
that are listed in paragraphs (a)(1) through (16) of this section and
are not prohibited by Sec.  751.605.
    (2) Owners or operators must ensure that all persons are separated,
distanced, physically removed, or isolated from direct dermal contact
with perchloroethylene in accordance with the requirements of paragraph
(d)(1)(ii) of this section and, if necessary, paragraph (f) of this
section.
    (d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) The owner or operator must institute one or a
combination of elimination, substitution, engineering controls or
administrative controls to reduce exposure to or below the ECEL except
to the extent that the owner or operator can demonstrate that such
controls are not feasible.
    (B) Wherever the feasible exposure controls, including one or a
combination of elimination, substitution, engineering controls or
administrative controls, which can be instituted are not sufficient to
reduce exposure to or below the ECEL, the owner or operator must use
them to reduce exposure to the lowest levels achievable by these
controls and must supplement them by the use of respiratory protection
that complies with the requirements of paragraph (f) of this section.
Where an owner or operator cannot demonstrate exposure below the ECEL,
including through the use of engineering controls or work practices,
and has not demonstrated that it has supplemented feasible exposure
controls with respiratory protection that complies with the
requirements of paragraph (f) of this section, this will constitute a
failure to comply with the ECEL.
    (C) The owner or operator must maintain the effectiveness of
engineering controls and administrative controls instituted under
paragraph (d)(1)(i)(A) of this section.
    (D) The owner or operator must not implement a schedule of
personnel rotation as a means of compliance with the ECEL.
    (E) The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (d)(2) of this section.
    (ii) Direct dermal contact control requirements. (A) The owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with perchloroethylene
except to the extent that the owner or operator can demonstrate that
such controls are not feasible.
    (B) Wherever the feasible exposure controls, including one or a
combination of elimination, substitution, engineering controls or
administrative controls, which can be instituted are not sufficient to
prevent direct dermal contact, the owner or operator must use them to
reduce direct dermal contact to the extent achievable by these controls
and must supplement them by the use of dermal personal protective
equipment that complies with the requirements of paragraph (f) of this
section. Where an owner or operator cannot demonstrate direct dermal
contact is prevented, including through the use of engineering controls
or work practices, and has not demonstrated that it has supplemented
feasible exposure controls with dermal personal protective equipment
that complies with the requirements of paragraph (f) of this section,
this will constitute a failure to comply with the direct dermal contact
control requirements.
    (C) The owner or operator must maintain the effectiveness of
engineering controls and administrative

controls instituted under paragraph (d)(1)(ii)(A) of this section.
    (D) The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (d)(2) of this section.
    (2) Exposure control plan requirements. Beginning [DATE 12 MONTHS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER],
owners and operators must include and document in an exposure control
plan the following:
    (i) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of perchloroethylene,
substitution of perchloroethylene, engineering controls and
administrative controls to reduce exposures in the workplace to either
at or below the ECEL or to the lowest level achievable and to prevent
or reduce direct dermal contact with perchloroethylene in the
workplace;
    (ii) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
    (iii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
    (iv) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
    (v) Description of any regulated area and how it is demarcated, and
identification of authorized persons; and description of when the owner
or operator expects exposures may be likely to exceed the ECEL;
    (vi) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
    (vii) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes air concentrations to be above
the ECEL or any direct dermal contact with perchloroethylene and
subsequent corrective actions taken during start-up, shutdown, or
malfunctions to mitigate exposures to perchloroethylene; and
    (viii) Availability of the exposure control plan and associated
records for potentially exposed persons.
    (e) Workplace information and training. (1) The owner or operator
must provide information and training for each person prior to or at
the time of initial assignment to a job involving potential exposure to
perchloroethylene.
    (2) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
    (3) The following information and training must be provided to all
persons assigned to a job involving potential exposure to
perchloroethylene:
    (i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
    (ii) The quantity, location, manner of use, release, and storage of
perchloroethylene and the specific operations in the workplace that
could result in exposure to perchloroethylene, particularly noting
where exposures may be above the ECEL or where there is potential for
direct dermal contact with perchloroethylene;
    (iii) Methods and observations that may be used to detect the
presence or release of perchloroethylene in the workplace (such as
monitoring conducted by the owner or operator, continuous monitoring
devices, visual appearance or odor of perchloroethylene when being
released, etc.);
    (iv) The health hazards of perchloroethylene in the workplace; and
    (v) The principles of safe use and handling of perchloroethylene
and measures potentially exposed persons can take to protect themselves
from perchloroethylene, including specific procedures the owner or
operator has implemented to protect potentially exposed persons from
exposure to perchloroethylene, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
    (4) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of
perchloroethylene in the workplace.
    (5) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures,
which increase exposure, and where those exposures exceed or can
reasonably be expected to exceed the ECEL action level or increase
potential for direct dermal contact, the owner or operator must update
the training as necessary to ensure that each potentially exposed
person has the requisite proficiency.
    (f) Personal protective equipment (PPE). (1) The provisions of this
paragraph (f) apply to any owner or operator that is required to
provide respiratory protection or dermal protection pursuant to
paragraph (d)(1)(i)(B) or (d)(1)(ii)(B) of this section or Sec.
751.609(b)(2).
    (2) PPE, including respiratory and dermal protection, that is of
safe design and construction for the work to be performed must be
provided, used, and maintained in a sanitary, reliable, and undamaged
condition. Owners and operators must select PPE that properly fits each
affected person and communicate PPE selections to each affected person.
    (3) Owners and operators must provide PPE training in accordance
with 29 CFR 1910.132(f) to all persons required to use PPE prior to or
at the time of initial assignment to a job involving potential exposure
to perchloroethylene. For the purposes of this paragraph (f)(3),
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
    (4) Owners and operators must retrain each potentially exposed
person required to use PPE annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use PPE, or when
changes in the workplace or in PPE to be used render the previous
training obsolete.
    (5) Respiratory protection. (i) Beginning [DATE 9 MONTHS AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], or within 3
months after receipt of any exposure monitoring that indicates
exposures exceeding the ECEL, the owner or operator must supply a
respirator, selected in accordance with this paragraph, to each person
who enters a regulated area and must ensure that all persons within the
regulated area are using the provided respirators whenever
perchloroethylene exposures may exceed the ECEL.
    (ii) Owners or operators must provide respiratory protection in
accordance with the provisions outlined in 29 CFR 1910.134(a) through
(l) (except paragraph (d)(1)(iii)) and as specified in this paragraph
for persons exposed or who may be exposed to perchloroethylene in
concentrations above the ECEL. For the purpose of this paragraph (f),
the maximum use concentration (MUC) as used in 29 CFR 1910.134 must be
calculated by multiplying the assigned protection factor (APF)
specified for a respirator by the ECEL. For the purposes of this
paragraph (f)(5)(ii), provisions in 29 CFR 1910.134(a) through (l)
(except paragraph (d)(1)(iii)) applying to an ``employee'' also apply
equally to potentially exposed persons, and

provisions applying to an ``employer'' also apply equally to owners or
operators.
    (iii) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
    (A) If the measured exposure concentration is at or below 0.14 ppm:
no respiratory protection is required.
    (B) If the measured exposure concentration is above 0.14 ppm and
less than or equal to 0.7 ppm (5 times ECEL): Any National Institute
for Occupational Safety and Health (NIOSH)-certified air-purifying
quarter mask respirator (APF 5).
    (C) If the measured exposure concentration is above 0.7 ppm and
less than or equal to 1.4 ppm (10 times ECEL): Any NIOSH-certified air-