Notice2022-27129
Perchloroethylene (PCE); Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability
Primary source
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Published
December 14, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of the final revision to the risk determination for the perchloroethylene (PCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). The revision to the PCE risk determination reflects the announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. In addition, this revised risk determination does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE). EPA understands that there could be adequate occupational safety protections in place at certain workplace locations; however, not assuming use of PPE reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or their employers are out of compliance with OSHA standards, or because many of OSHA's chemical- specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being "outdated and inadequate for ensuring protection of worker health," or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. This revision supersedes the condition of use-specific no unreasonable risk determinations in the December 2020 PCE Risk Evaluation and withdraws the associated TSCA order included in the December 2020 PCE Risk Evaluation.
Full Text
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[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76481-76487]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27129]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0732; FRL-9942-02-OCSPP]
Perchloroethylene (PCE); Revision to Toxic Substances Control Act
(TSCA) Risk Determination; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final revision to the risk determination for the
perchloroethylene (PCE) risk evaluation issued under the Toxic
Substances Control Act (TSCA). The revision to the PCE risk
determination reflects the announced policy changes to ensure the
public is protected from unreasonable risks from chemicals in a way
that is supported by science and the law. EPA determined that PCE, as a
whole chemical substance, presents an unreasonable risk of injury to
health when evaluated under its conditions of use. In addition, this
revised risk determination does not reflect an assumption that workers
always appropriately wear personal protective equipment (PPE). EPA
understands that there could be adequate occupational safety
protections in place at certain workplace locations; however, not
assuming use of PPE reflects EPA's recognition that unreasonable risk
may exist for subpopulations of workers that may be highly exposed
because they are not covered by Occupational Safety and Health
Administration (OSHA) standards, or their employers are out of
compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are
described by OSHA as being ``outdated and inadequate for ensuring
protection of worker health,'' or because EPA finds unreasonable risk
for purposes of TSCA notwithstanding OSHA requirements. This revision
supersedes the condition of use-specific no unreasonable risk
determinations in the December 2020
[[Page 76482]]
PCE Risk Evaluation and withdraws the associated TSCA order included in
the December 2020 PCE Risk Evaluation.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0732, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kelly Summers, Office of Pollution Prevention and Toxics (7404T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-2201; email address:
<a href="/cdn-cgi/l/email-protection#d1a2a4bcbcb4a3a2ffbab4bdbda891b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="1a696f77777f686934717f7676635a7f6a7b347d756c">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#01555242402c496e756d686f64416471602f666e77"><span class="__cf_email__" data-cfemail="590d0a1a187411362d3530373c193c2938773e362f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to those involved in the manufacture, processing,
distribution, use, disposal, and/or the assessment of risks involving
chemical substances and mixtures. You may be potentially affected by
this action if you manufacture (defined under TSCA to include import),
process (including recycling), distribute in commerce, use or dispose
of PCE, including PCE in products. Since other entities may also be
interested in this revision to the risk determination, EPA has not
attempted to describe all the specific entities that may be affected by
this action.
B. What is EPA's authority for taking this action?
TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
(PESS) identified as relevant to the risk evaluation by the
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A).
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and
minimum requirements applicable to this process, including provisions
that provide instruction on chemical substances that must undergo
evaluation, the minimum components of a TSCA risk evaluation, and the
timelines for public comment and completion of the risk evaluation.
TSCA also requires that EPA operate in a manner that is consistent with
the best available science, make decisions based on the weight of the
scientific evidence, and consider reasonably available information. 15
U.S.C. 2625(h), (i), and (k).
The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
EPA has inherent authority to reconsider previous decisions and to
revise, replace, or repeal a decision to the extent permitted by law
and supported by reasoned explanation. FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to
such authority, EPA has reconsidered and is now finalizing a revised
risk determination for PCE.
C. What action is EPA taking?
EPA is announcing the availability of the final revision to the
risk determination for the PCE risk evaluation issued under TSCA that
published in December 2020 (Ref. 1). In June 2022, EPA sought public
comment on the draft revisions (87 FR 39085, June 30, 2022). EPA
appreciates the public comments received on the draft revision to the
PCE risk determination. After review of these comments and
consideration of the specific circumstances of PCE, EPA concludes that
the Agency's risk determination for PCE is better characterized as a
whole chemical risk determination rather than condition-of-use-specific
risk determinations. Accordingly, EPA is revising and replacing section
5 of the December 2020 PCE Risk Evaluation (Ref. 2) where the findings
of unreasonable risk to health were previously made for the individual
conditions of use evaluated. EPA is also withdrawing the previously
issued TSCA section 6(i)(l) order for two conditions of use previously
determined not to present unreasonable risk which was included in
section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2).
This final revision to the PCE risk determination is consistent
with EPA's plans to revise specific aspects of the first ten TSCA
chemical risk evaluations to ensure that the risk evaluations better
align with TSCA's objective of protecting health and the environment.
As a result of this revision, removing the assumption that workers
always and appropriately wear PPE (see Unit II.C.) means that: one
condition of use in addition to the original 59 conditions of use
drives the unreasonable risk for PCE; an additional route of exposure
(i.e., inhalation) is also identified as driving the unreasonable risk
to workers in many of those 59 conditions of use; and additional risks
for acute non-cancer effects and cancer from inhalation and dermal
exposures also drive the unreasonable risk in many of those 59
conditions of use (where previously those conditions of use were
identified as presenting unreasonable risk only for chronic non-cancer
effects or for chronic non-cancer effects and cancer). However, EPA is
not making condition-of-use-specific risk determinations for those
conditions of use, and for purposes of TSCA section 6(i), EPA is not
issuing a final order under TSCA section 6(i)(1) for the condition of
use that does not drive the unreasonable risk and does not consider the
revised risk determination to constitute a final agency action at this
[[Page 76483]]
point in time. Overall, 60 conditions of use out of 61 EPA evaluated
drive the PCE whole chemical unreasonable risk determination due to
risks identified for human health. The full list of the conditions of
use evaluated for the PCE TSCA risk evaluation is in Table 1-4 of the
December 2020 PCE Risk Evaluation (Ref. 2).
II. Background
A. Why is EPA re-issuing the risk determination for the PCE risk
evaluation conducted under TSCA?
In accordance with Executive Order 13990 (``Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis'') and other Administration priorities (Refs. 3, 4, 5, and 6),
EPA reviewed the risk evaluations for the first ten chemical
substances, including PCE, to ensure that they meet the requirements of
TSCA, including conducting decision-making in a manner that is
consistent with the best available science.
As a result of this review, EPA announced plans to revise specific
aspects of the first ten risk evaluations in order to ensure that the
risk evaluations appropriately identify unreasonable risks and thereby
help ensure the protection of human health and the environment (Ref.
7). Following a review of specific aspects of the December 2020 PCE
Risk Evaluation (Ref. 2) and after considering comments received on a
draft revised risk determination for PCE, EPA has determined that
making an unreasonable risk determination for PCE as a whole chemical
substance, rather than making unreasonable risk determinations
separately on each individual condition of use evaluated in the risk
evaluation, is the most appropriate approach for PCE under the statute
and implementing regulations. In addition, EPA's final risk
determination is explicit insofar as it does not rely on assumptions
regarding the use of PPE in making the unreasonable risk determination
under TSCA section 6, even though some facilities might be using PPE as
one means to reduce worker exposures; rather, the use of PPE as a means
of addressing unreasonable risk will be considered during risk
management, as appropriate.
Separately, EPA is conducting a screening approach to assess risks
from the air and water pathways for several of the first 10 chemicals,
including this chemical. For PCE the exposure pathways that were or
could be regulated under another EPA administered statute were excluded
from the final risk evaluation (see section 1.4.2 of the December 2020
PCE Risk Evaluation). This resulted in the ambient air and ambient
water pathways for PCE not being assessed. The goal of the recently-
developed screening approach is to remedy this exclusion and to
determine if there may be risks that were unaccounted for in the PCE
risk evaluation.
The screening-level approach has gone through public comment and
independent external peer review through the SACC. The Agency received
the final peer review report on May 18, 2022, and has reviewed public
comments and SACC comments. EPA expects to describe its findings
regarding the chemical-specific application of this screening-level
approach in the forthcoming proposed rule under TSCA section 6(a) for
PCE.
This action pertains only to the risk determination for PCE. While
EPA intends to consider and may take additional similar actions on
other of the first ten chemicals, EPA is taking a chemical-specific
approach to reviewing these risk evaluations and is incorporating new
policy direction in a surgical manner, while being mindful of
Congressional direction on the need to complete risk evaluations and
move toward any associated risk management activities in accordance
with statutory deadlines.
B. What is a whole chemical view of the unreasonable risk determination
for the PCE risk evaluation?
TSCA section 6 repeatedly refers to determining whether a chemical
substance presents unreasonable risk under its conditions of use.
Stakeholders have disagreed over whether a chemical substance should
receive: A single determination that is comprehensive for the chemical
substance after considering the conditions of use, referred to as a
whole-chemical determination; or multiple determinations, each of which
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
As explained in the Federal Register document announcing the
availability of the draft revised risk determination for PCE (87 FR
39085, June 30, 2022 (FRL-9942-01-OCSPP)), the proposed Risk Evaluation
Procedural Rule (Ref. 8) was premised on the whole chemical approach to
making unreasonable risk determinations. In that proposed rule, EPA
acknowledged a lack of specificity in statutory text that might lead to
different views about whether the statute compelled EPA's risk
evaluations to address all conditions of use of a chemical substance or
whether EPA had discretion to evaluate some subset of conditions of use
(i.e., to scope out some manufacturing, processing, distribution in
commerce, use, or disposal activities), but also stated that ``EPA
believes the word `the' [in TSCA section 6(b)(4)(A)] is best
interpreted as calling for evaluation that considers all conditions of
use.'' The proposed rule, however, was unambiguous on the point that
unreasonable risk determinations would be for the chemical substance as
a whole, even if based on a subset of uses. See Ref. 8 at pages 7565-66
(``TSCA section 6(b)(4)(A) specifies that a risk evaluation must
determine whether `a chemical substance' presents an unreasonable risk
of injury to health or the environment `under the conditions of use.'
The evaluation is on the chemical substance--not individual conditions
of use--and it must be based on `the conditions of use.' In this
context, EPA believes the word `the' is best interpreted as calling for
evaluation that considers all conditions of use.''). In the proposed
regulatory text, EPA proposed to determine whether the chemical
substance presents an unreasonable risk of injury to health or the
environment under the conditions of use. (Ref. 8 at 7480.)
The final Risk Evaluation Procedural Rule stated (82 FR 33726, July
20, 2017 (FRL-9964-38)) (Ref. 9): ``As part of the risk evaluation, EPA
will determine whether the chemical substance presents an unreasonable
risk of injury to health or the environment under each condition of
uses [sic] within the scope of the risk evaluation, either in a single
decision document or in multiple decision documents'' (40 CFR 702.47).
For the unreasonable risk determinations in the first ten risk
evaluations, EPA applied this provision by making individual risk
determinations for each condition of use evaluated as part of each risk
evaluation document (i.e., the condition-of-use-specific approach to
risk determinations). That approach was based on one particular passage
in the preamble to the final Risk Evaluation Rule which stated that EPA
will make individual risk determinations for all conditions of use
identified in the scope. (Ref. 9 at 33744).
In contrast to this portion of the preamble of the final Risk
Evaluation Rule, the regulatory text itself and other statements in the
preamble reference a risk determination for the chemical substance
under its conditions of use, rather than separate risk determinations
for each of the conditions of use of a chemical substance. In the key
regulatory provision excerpted previously from 40 CFR 702.47, the text
[[Page 76484]]
explains that ``[a]s part of the risk evaluation, EPA will determine
whether the chemical substance presents an unreasonable risk of injury
to health or the environment under each condition of uses [sic] within
the scope of the risk evaluation, either in a single decision document
or in multiple decision documents'' (Ref. 9, emphasis added). Other
language reiterates this perspective. For example, 40 CFR 702.31(a)
states that the purpose of the rule is to establish the EPA process for
conducting a risk evaluation to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment as
required under TSCA section 6(b)(4)(B). Likewise, there are recurring
references to whether the chemical substance presents an unreasonable
risk in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which
explains that the extent to which EPA will refine its evaluations for
one or more condition of use in any risk evaluation will vary as
necessary to determine whether a chemical substance presents an
unreasonable risk. Notwithstanding the one preambular statement about
condition-of-use-specific risk determinations, the preamble to the
final rule also contains support for a risk determination on the
chemical substance as a whole. In discussing the identification of the
conditions of use of a chemical substance, the preamble notes that this
task inevitably involves the exercise of discretion on EPA's part, and
``as EPA interprets the statute, the Agency is to exercise that
discretion consistent with the objective of conducting a technically
sound, manageable evaluation to determine whether a chemical
substance--not just individual uses or activities--presents an
unreasonable risk'' (Ref. 9 at 33729).
Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk
evaluation regulation to also allow the Agency to issue whole-chemical
risk determinations. Either approach is permissible under the
regulation. A panel of the Ninth Circuit Court of Appeals also
recognized the ambiguity of the regulation on this point. Safer
Chemicals v. EPA, 943 F.3d. 397, 413 (9th Cir. 2019) (holding a
challenge about ``use-by-use risk evaluations [was] not justiciable
because it is not clear, due to the ambiguous text of the Risk
Evaluation Rule, whether the Agency will actually conduct risk
evaluations in the manner Petitioners fear'').
EPA plans to consider the appropriate approach for each chemical
substance risk evaluation on a case-by-case basis, taking into account
considerations relevant to the specific chemical substance in light of
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's
ability to evaluate and manage unreasonable risk from individual
chemical substances. EPA believes this is a reasonable approach under
TSCA and the Agency's implementing regulations.
With regard to the specific circumstances of PCE, EPA has
determined that a whole chemical approach is appropriate for PCE in
order to protect health and the environment. The whole chemical
approach is appropriate for PCE because there are benchmark exceedances
for a substantial number of conditions of use (spanning across most
aspects of the chemical lifecycle--from manufacturing (including
import), processing, industrial and commercial use, consumer use, and
disposal) for workers, occupational non-users, consumers, and
bystanders and risk of irreversible health effects (specifically
neurotoxicity and cancer) associated with PCE exposures. Because these
chemical-specific properties cut across the conditions of use within
the scope of the risk evaluation, a substantial amount of the
conditions of use drive the unreasonable risk; therefore, it is
appropriate for the Agency to make a determination for PCE that the
whole chemical presents an unreasonable risk.
As explained later in this document, the revisions to the
unreasonable risk determination (section 5 of the December 2020 PCE
Risk Evaluation (Ref. 2)) follow the issuance of a draft revision to
the TSCA PCE unreasonable risk determination (87 FR 39085, June 30,
2022) and the receipt of public comment. A response to comments
document is also being issued with the final revised unreasonable risk
determination for PCE (Ref. 10). The revisions to the unreasonable risk
determination are based on the existing risk characterization section
of the December 2020 PCE Risk Evaluation (Ref. 2) (section 4) and do
not involve additional technical or scientific analysis. The discussion
of the issues in this Federal Register document and in the accompanying
final revised risk determination for PCE supersede any conflicting
statements in the December 2020 PCE Risk Evaluation (Ref. 2) and the
earlier response to comments document (Ref. 11). EPA views the peer
reviewed hazard and exposure assessments and associated risk
characterization as robust and upholding the standards of best
available science and weight of the scientific evidence per TSCA
sections 26(h) and (i).
For purposes of TSCA section 6(i), EPA is making a risk
determination on PCE as a whole chemical. Under the revised approach,
the ``whole chemical'' risk determination for PCE supersedes the no
unreasonable risk determinations for PCE that were premised on a
condition-of-use-specific approach to determining unreasonable risk and
also contains an order withdrawing the TSCA section 6(i)(1) order in
section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2).
C. What revision is EPA now making final about the use of PPE for the
PCE risk evaluation?
In the risk evaluations for the first ten chemical substances, as
part of the unreasonable risk determination, EPA assumed for several
conditions of use that workers were provided and always used PPE in a
manner that achieves the stated assigned protection factor (APF) for
respiratory protection, or used impervious gloves for dermal
protection. In support of this assumption, EPA used reasonably
available information such as public comments indicating that some
employers, particularly in the industrial setting, provide PPE to their
employees and follow established worker protection standards (e.g.,
OSHA requirements for protection of workers).
For the December 2020 PCE Risk Evaluation (Ref. 2), EPA assumed,
based on reasonably available information that workers use PPE--
specifically, respirators with an APF ranging from 25 to 50 and gloves
with PF 10 or 20--for 26 occupational conditions of use. In the
December 2020 PCE Risk Evaluation, EPA determined that there is
unreasonable risk for 25 of those occupational conditions of use.
EPA is revising the assumption for PCE that workers always and
properly use PPE. However, this does not mean that EPA questions the
veracity of public comments which describe occupational safety
practices often followed by industry. EPA believes it is appropriate
when conducting risk evaluations under TSCA to evaluate the levels of
risk present in baseline scenarios where PPE is not assumed to be used
by workers. This approach of not assuming PPE use by workers considers
the risk to potentially exposed or susceptible subpopulations of
workers who may not be covered by OSHA standards, such as self-employed
individuals and public sector workers who are not covered by a State
Plan. It should be noted that, in some cases,
[[Page 76485]]
baseline conditions may reflect certain mitigation measures, such as
engineering controls, in instances where exposure estimates are based
on monitoring data at facilities that have engineering controls in
place.
In addition, EPA believes it is appropriate to evaluate the levels
of risk present in scenarios considering applicable OSHA requirements
(e.g., chemical-specific permissible exposure limits (PELs) and/or
chemical-specific PELs with additional substance-specific standards),
as well as scenarios considering industry or sector best practices for
industrial hygiene that are clearly articulated to the Agency.
Consistent with this approach, the December 2020 PCE Risk Evaluation
(Ref. 2) characterized risk to workers both with and without the use of
PPE. By characterizing risks using scenarios that reflect different
levels of mitigation, EPA risk evaluations can help inform potential
risk management actions by providing information that could be used
during risk management to tailor risk mitigation appropriately to
address any unreasonable risk identified, or to ensure that applicable
OSHA requirements or industry or sector best practices that address the
unreasonable risk are required for all potentially exposed and
susceptible subpopulations (including self-employed individuals and
public sector workers who are not covered by an OSHA State Plan).
When undertaking unreasonable risk determinations as part of TSCA
risk evaluations, however, EPA does not believe it is appropriate to
assume as a general matter that an applicable OSHA requirement or
industry practice related to PPE use is consistently and always
properly applied. Mitigation scenarios included in the EPA risk
evaluation (e.g., scenarios considering use of various PPE) likely
represent what is happening already in some facilities. However, the
Agency cannot assume that all facilities have adopted these practices
for the purposes of making the TSCA risk determination (Ref. 12).
Therefore, EPA is making a determination of unreasonable risk for
PCE from a baseline scenario that does not assume compliance with OSHA
standards, including any applicable exposure limits or requirements for
use of respiratory protection or other PPE. Making unreasonable risk
determinations based on the baseline scenario should not be viewed as
an indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread non-
compliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that unreasonable risk may exist for subpopulations of
workers that may be highly exposed because they are not covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by a State Plan, or because their employer is out
of compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are
described by OSHA as being ``outdated and inadequate for ensuring
protection of worker health,'' (Ref. 13), or because EPA finds
unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements.
In accordance with this approach, EPA is finalizing the revision to
the PCE risk determination without relying on assumptions regarding the
occupational use of PPE in making the unreasonable risk determination
under TSCA section 6; rather, information on the use of PPE as a means
of mitigating risk (including public comments received from industry
respondents about occupational safety practices in use) will be
considered during the risk management phase, as appropriate. This
represents a change from the approach taken in the December 2020 PCE
Risk Evaluation (Ref. 2). As a general matter, when undertaking risk
management actions, EPA intends to strive for consistency with
applicable OSHA requirements and industry best practices, including
appropriate application of the hierarchy of controls, to the extent
that applying those measures would address the identified unreasonable
risk, including unreasonable risk to potentially exposed or susceptible
subpopulations. Consistent with TSCA section 9(d), EPA will consult and
coordinate TSCA activities with OSHA and other relevant Federal
agencies for the purpose of achieving the maximum applicability of TSCA
while avoiding the imposition of duplicative requirements. Informed by
the mitigation scenarios and information gathered during the risk
evaluation and risk management process, the Agency might propose rules
that require risk management practices that may be already common
practice in many or most facilities. Adopting clear, comprehensive
regulatory standards will foster compliance across all facilities
(ensuring a level playing field) and assure protections for all
affected workers, especially in cases where current OSHA standards may
not apply or be sufficient to address the unreasonable risk.
Removing the assumption that workers always and appropriately wear
PPE in making the whole chemical risk determination for PCE means that:
one condition of use in addition to the original 59 conditions of use
drives the unreasonable risk for PCE; an additional route of exposure
(i.e., inhalation) is also identified as driving the unreasonable risk
to workers in many of those 59 conditions of use; and additional risks
for acute non-cancer effects and cancer from inhalation and dermal
exposures also drive the unreasonable risk in many of those 59
conditions of use (where previously those conditions of use were
identified as presenting unreasonable risk only for chronic non-cancer
effects or for chronic non-cancer effects and cancer). The finalized
revision to the PCE risk determination clarifies that EPA does not rely
on the assumed use of PPE when making the risk determination for the
whole substance; rather, the use of PPE as a means of addressing
unreasonable risk will be considered during risk management, as
appropriate.
D. What is PCE?
PCE is a colorless liquid and a volatile organic compound that is
manufactured (including imported), processed, distributed, used, and
disposed of as part of industrial, commercial, and consumer conditions
of use. PCE has a wide range of uses, including production of
fluorinated compounds and as a solvent in dry cleaning and vapor
degreasing. A variety of consumer and commercial products use PCE, such
as adhesives (arts and crafts, as well as light repairs), aerosol
degreasers, brake cleaners, aerosol lubricants, sealants, stone polish,
stainless steel polish, and wipe cleaners. The total aggregate
production volume reported for PCE under the Chemical Data Reporting
rule ranged from 324 million to 388 million pounds between 2012 and
2015.
E. What conclusions is EPA finalizing today in the revised TSCA risk
evaluation based on the whole chemical approach and not assuming the
use of PPE?
EPA determined that PCE presents an unreasonable risk to health
under the conditions of use. EPA's unreasonable risk determination for
PCE as a chemical substance is driven by risks associated with the
following conditions of use, considered singularly or in combination
with other exposures:
<bullet> Manufacturing (domestic manufacture);
<bullet> Manufacturing (import);
<bullet> Processing as a reactant/intermediate;
<bullet> Processing into formulation, mixture or reaction product
for cleaning and degreasing products;
[[Page 76486]]
<bullet> Processing into formulation, mixture or reaction product
for adhesive and sealant products;
<bullet> Processing into formulation, mixture or reaction product
for paint and coating products;
<bullet> Processing into formulation, mixture or reaction product
for other chemical products and preparations;
<bullet> Processing by repackaging;
<bullet> Recycling;
<bullet> Industrial and commercial use as solvent for open-top
batch vapor degreasing;
<bullet> Industrial and commercial use as solvent for closed-loop
batch vapor degreasing;
<bullet> Industrial and commercial use as solvent for in-line
conveyorized vapor degreasing;
<bullet> Industrial and commercial use as solvent for in-line web
cleaner vapor degreasing;
<bullet> Industrial and commercial use as solvent for cold
cleaning;
<bullet> Industrial and commercial use as solvent for aerosol spray
degreaser/cleaner;
<bullet> Industrial and commercial use as a solvent for aerosol
lubricants;
<bullet> Industrial and commercial use as a solvent for penetrating
lubricants and cutting tool coolants;
<bullet> Industrial and commercial use in solvent-based adhesives
and sealants;
<bullet> Industrial and commercial use in solvent-based paints and
coatings;
<bullet> Industrial and commercial use in maskants for chemical
milling;
<bullet> Industrial and commercial use as a processing aid in
pesticide, fertilizer and other agricultural chemical manufacturing;
<bullet> Industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing;
<bullet> Industrial and commercial use in wipe cleaning;
<bullet> Industrial and commercial use in other spot cleaning and
spot removers, including carpet cleaning;
<bullet> Industrial and commercial use in mold release;
<bullet> Industrial and commercial use in dry cleaning and spot
cleaning post-2006 dry cleaning;
<bullet> Industrial and commercial use in dry cleaning and spot
cleaning 4th/5th gen only dry cleaning;
<bullet> Industrial and commercial use in automotive care products
(e.g., engine degreaser and brake cleaner);
<bullet> Industrial and commercial use in non-aerosol cleaner;
<bullet> Industrial and commercial use in metal (e.g., stainless
steel) and stone polishes;
<bullet> Industrial and commercial use in laboratory chemicals;
<bullet> Industrial and commercial use in welding;
<bullet> Industrial and commercial use in other textile processing;
<bullet> Industrial and commercial use in wood furniture
manufacturing;
<bullet> Industrial and commercial use in foundry applications;
<bullet> Industrial and commercial use in specialty Department of
Defense uses (oil analysis and water pipe repair);
<bullet> Commercial use in inks and ink removal products (based on
printing);
<bullet> Commercial use in inks and ink removal products (based on
photocopying);
<bullet> Commercial use for photographic film;
<bullet> Commercial use in mold cleaning, release and protectant
products;
<bullet> Consumer use in cleaners and degreasers (other);
<bullet> Consumer use as a dry cleaning solvent;
<bullet> Consumer use in automotive care products (brake cleaner);
<bullet> Consumer use in automotive care products (parts cleaner);
<bullet> Consumer use in aerosol cleaner (vandalism mark and stain
remover);
<bullet> Consumer use in non-aerosol cleaner (e.g., marble and
stone polish);
<bullet> Consumer use in lubricants and greases (cutting fluid);
<bullet> Consumer use in lubricants and greases (lubricants and
penetrating oils);
<bullet> Consumer use in adhesives for arts and crafts (including
industrial adhesive, arts and crafts adhesive, gun ammunition sealant);
<bullet> Consumer use in adhesives for arts and crafts (livestock
grooming adhesive);
<bullet> Consumer use in adhesives for arts and crafts (column
adhesive, caulk and sealant);
<bullet> Consumer use in solvent-based paints and coatings (outdoor
water shield (liquid));
<bullet> Consumer use in solvent-based paints and coatings
(coatings and primers (aerosol));
<bullet> Consumer use in solvent-based paints and coatings (rust
primer and sealant (liquid));
<bullet> Consumer use in solvent-based paints and coatings
(metallic overglaze);
<bullet> Consumer use in metal (e.g., stainless steel) and stone
polishes;
<bullet> Consumer use in inks and ink removal products;
<bullet> Consumer use in welding;
<bullet> Consumer use in mold cleaning, release and protectant
products; and
<bullet> Disposal.
The following condition of use does not drive EPA's unreasonable
risk determination for PCE:
<bullet> Distribution in commerce.
EPA is not making a condition of use-specific risk determination
for this condition of use, is not issuing a final order under TSCA
section 6(i)(1) for this condition of use and does not consider the
revised risk determination for PCE to constitute a final agency action
at this point in time.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose a risk management regulatory action to the extent
necessary so that PCE no longer presents an unreasonable risk. EPA
expects to focus its risk management action on the conditions of use
that drive the unreasonable risk. However, it should be noted that,
under TSCA section 6(a), EPA is not limited to regulating the specific
activities found to drive unreasonable risk and may select from among a
suite of risk management requirements in section 6(a) related to
manufacture (including import), processing, distribution in commerce,
commercial use, and disposal as part of its regulatory options to
address the unreasonable risk. As a general example, EPA may regulate
upstream activities (e.g., processing, distribution in commerce) to
address downstream activities (e.g., consumer uses) driving
unreasonable risk, even if the upstream activities do not drive the
unreasonable risk.
III. Summary of Public Comments
EPA received a total of 20 unique public comments on the June 30,
2022, draft revised risk determination for PCE during the comment
period that ended August 1, 2022. Commenters included trade
organizations, industry stakeholders, environmental groups, and non-
governmental health advocacy organizations. A separate document that
summarizes all comments submitted and EPA's responses to those comments
has been prepared and is available in the docket for this notice (Ref.
10).
IV. Revision of the December 2020 PCE Risk Evaluation
A. Why is EPA revising the risk determination for the PCE risk
evaluation?
EPA is finalizing the revised risk determination for the PCE risk
evaluation pursuant to TSCA section 6(b) and consistent with Executive
Order 13990, (``Protecting Public Health and the Environment and
Restoring Science to Tackle the Climate Crisis'') and other
Administration priorities (Refs. 3, 4, 5, and 6). EPA is revising
specific aspects of the first ten TSCA existing chemical risk
evaluations in order to ensure that the risk evaluations
[[Page 76487]]
better align with TSCA's objective of protecting health and the
environment. For the PCE risk evaluation, this includes: (1) Making the
risk determination in this instance based on the whole chemical
substance instead of by individual conditions of use and (2)
Emphasizing that EPA does not rely on the assumed use of PPE when
making the risk determination.
B. What are the revisions?
EPA is now finalizing the revised risk determination for the
December 2020 PCE Risk Evaluation (Ref. 2) pursuant to TSCA section
6(b). Under the revised determination (Ref. 1), EPA concludes that PCE,
as evaluated in the risk evaluation as a whole, presents an
unreasonable risk of injury to health when evaluated under its
conditions of use. This revision replaces the previous unreasonable
risk determinations made for PCE by individual conditions of use,
supersedes the determinations (and withdraws the associated order) of
no unreasonable risk for the conditions of use identified in the TSCA
section 6(i)(1) no unreasonable risk order, and clarifies the lack of
reliance on assumed use of PPE as part of the risk determination.
These revisions do not alter any of the underlying technical or
scientific information that informs the risk characterization, and as
such the hazard, exposure, and risk characterization sections are not
changed, except to statements about PPE assumptions in section 2.4.1.4
(Consideration of Engineering Controls and PPE) and section 4.2.2.2
(Occupational Inhalation Exposure Summary and PPE Use Determinations by
OES). The discussion of the issues in this Notice and in the
accompanying final revision to the risk determination supersede any
conflicting statements in the prior executive summary, section 2.4.1.4
and section 4.2.2.2 from the December 2020 PCE Risk Evaluation (Ref.
2), and the response to comments document (Ref. 11).
The revised unreasonable risk determination for PCE includes
additional explanation of how the risk evaluation characterizes the
applicable OSHA requirements, or industry or sector best practices, and
also clarifies that no additional analysis was done, and the risk
determination is based on the risk characterization (section 4) of the
December 2020 PCE Risk Evaluation (Ref. 2).
C. Will the revised risk determination be peer reviewed?
The risk determination (section 5 of the December 2020 PCE Risk
Evaluation (Ref. 2)) was not part of the scope of the Science Advisory
Committee on Chemicals (SACC) peer review of the PCE risk evaluation.
Thus, consistent with that approach, EPA did not conduct peer review of
the final revised unreasonable risk determination for the PCE risk
evaluation because no technical or scientific changes were made to the
hazard or exposure assessments or the risk characterization.
V. Order Withdrawing Previous Order Regarding Unreasonable Risk
Determinations for Certain Conditions of Use
EPA is also issuing a new order to withdraw the TSCA section
6(i)(1) no unreasonable risk order issued in section 5.4.1 of the
December 2020 PCE Risk Evaluation (Ref. 2). This final revised risk
determination supersedes the condition of use-specific no unreasonable
risk determinations in the December 2020 PCE Risk Evaluation (Ref. 2).
The order contained in section 5.5 of the revised risk determination
(Ref. 1) withdraws the TSCA section 6(i)(1) order contained in section
5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2). Consistent
with the statutory requirements of section 6(a), the Agency will
propose risk management action to address the unreasonable risk
determined in the PCE risk evaluation.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Unreasonable Risk Determination for Perchloroethylene (PCE).
December 2022.
2. EPA. Risk Evaluation for Perchloroethylene. December 2020. EPA
Document #740-R1-8011. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0057">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0057</a>.
3. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021).
4. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
5. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register (86 FR 7619, February 1, 2021).
6. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
7. EPA. Press Release; EPA Announces Path Forward for TSCA Chemical
Risk Evaluations. June 2021. <a href="https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations">https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations</a>.
8. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
7562, January 19, 2017) (FRL-9957-75).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register (82 FR
33726, 33744, July 20, 2017).
10. EPA. Response to Public Comments to the Revised Unreasonable
Risk Determination; Perchloroethylene (PCE). December 2022.
11. EPA. Summary of External Peer Review and Public Comments and
Disposition for Perchloroethylene (PCE). December 2020. Available
at: <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0059">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0502-0059</a>.
12. Occupational Safety and Health Administration (OSHA). Top 10
Most Frequently Cited Standards for Fiscal Year 2021 (Oct. 1, 2020,
to Sept. 30, 2021). Accessed October 13, 2022. <a href="https://www.osha.gov/top10citedstandards">https://www.osha.gov/top10citedstandards</a>.
13. OSHA. Permissible Exposure Limits--Annotated Tables. Accessed
June 13, 2022. <a href="https://www.osha.gov/annotated-pels">https://www.osha.gov/annotated-pels</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 9, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-27129 Filed 12-13-22; 8:45 am]
BILLING CODE 6560-50-P
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