[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Notices]
[Pages 43265-43270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15516]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2016-0741; FRL-9944-01-OCSPP]
1-Bromopropane (1-BP); Draft Revision to Toxic Substances Control
Act (TSCA) Risk Determination; Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and seeking public comment on a draft revision to the
risk determination for the 1-bromopropane (1-BP) risk evaluation issued
under TSCA. The draft revision to the 1-BP risk determination reflects
the announced policy changes to ensure the public is protected from
unreasonable risks from chemicals in a way that is supported by science
and the law. In this draft revision to the risk determination EPA finds
that 1-BP, as a whole chemical substance, presents an unreasonable risk
of injury to health when evaluated under its conditions of use. In
addition, this revised risk determination does not reflect an
assumption that all workers always appropriately wear personal
protective equipment (PPE). EPA understands that there could be
occupational safety protections in place at workplace locations;
however, not assuming use of PPE reflects EPA's recognition that
unreasonable risk may exist for subpopulations of workers that may be
highly exposed because they are not covered by OSHA standards, or their
employers are out of compliance with OSHA standards, or because OSHA
has not issued a permissible exposure limit (PEL) (as is the case for
1-BP). This revision, when final, would supersede the condition of use-
specific no unreasonable risk determinations in the August 2020 1-BP
risk evaluation (and withdraw the associated order) and would make a
revised determination of unreasonable risk for 1-BP as a whole chemical
substance.
DATES: Comments must be received on or before August 19, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-EPA-HQ-OPPT-2016-0741, using the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Amy Shuman, Office of Pollution
Prevention and Toxics (7404M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-2978; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, use, disposal, and/or the assessment of risks
involving chemical substances and mixtures. You may be potentially
affected by this action if you manufacture (defined under TSCA to
include import), process (including recycling), distribute in commerce,
use or dispose of 1-BP, including 1-BP in products. Since other
entities may also be interested in this draft revision to the risk
determination, EPA has not attempted to describe all the specific
entities that may be affected by this action.
B. What is EPA's authority for taking this action?
TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
(PESS) identified as relevant to the risk evaluation by the
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A).
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and
minimum requirements applicable to this process, including provisions
that provide instruction on chemical substances that must undergo
evaluation, the minimum components of a TSCA risk evaluation, and the
timelines for public comment and completion of the risk evaluation.
TSCA also requires that EPA operate in a manner that is consistent with
the best available science, make decisions based on the weight of the
scientific evidence, and consider reasonably available information. 15
U.S.C. 2625(h), (i), and (k).
The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other non-risk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
EPA has inherent authority to reconsider previous decisions and to
revise, replace, or repeal a decision to the extent permitted by law
and supported by reasoned explanation. FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to
such authority, EPA is reconsidering the risk determinations in the
August 2020 1-BP Risk Evaluation.
C. What action is EPA taking?
EPA is announcing the availability of and seeking public comment on
a draft revision to the risk determination for the risk evaluation for
1-BP under TSCA, which was initially published in August 2020 (Ref. 1).
EPA is specifically seeking public comment on the draft revision to
[[Page 43266]]
the risk determination for the risk evaluation where the Agency intends
to determine that 1-BP, as a whole chemical, presents an unreasonable
risk of injury to health when evaluated under its conditions of use.
The Agency's risk determination for 1-BP is better characterized as a
whole chemical risk determination rather than condition-of-use-specific
risk determinations. Accordingly, EPA would revise and replace section
5 of the risk evaluation for 1-BP where the findings of unreasonable
risk to health were previously made for the individual conditions of
use evaluated. EPA would also withdraw the order issued previously for
nine conditions of use previously determined not to present
unreasonable risk.
This revision would be consistent with EPA's plans to revise
specific aspects of the first ten TSCA chemical risk evaluations in
order to ensure that the risk evaluations better align with TSCA's
objective of protecting health and the environment. Under the draft
revision removing the assumptions that all workers always and
appropriately use PPE (see Unit II.C.) in making the whole chemical
risk determination for 1-BP would mean that: seven conditions of use in
addition to the original 16 would drive the unreasonable risk
determination for 1-BP; additional risks of cancer from dermal
exposures would also drive the unreasonable risk to workers in six
conditions of use; additional risks for acute and chronic non-cancer
effects from inhalation exposures would also drive the unreasonable
risk to workers in two conditions of use; and additional risks for
acute and chronic non-cancer effects and cancer from inhalation and
dermal exposures to workers would also drive the unreasonable risk in
one conditions of use (where previously this condition of use was
identified as presenting unreasonable risk only to ONUs). Overall, 23
conditions of use out of the 25 EPA evaluated drive the 1-BP whole
chemical unreasonable risk determination due to risks identified for
human health. The full list of the conditions of use evaluated for the
1-BP TSCA risk evaluation is in Table 4-58 and 4-59 of the risk
evaluation (Ref. 2).
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. Why is EPA re-issuing the risk determination for the 1-BP risk
evaluation conducted under TSCA?
In 2016, as directed by TSCA section 6(b)(2)(A), EPA chose the
first ten chemical substances to undergo risk evaluations under the
amended TSCA. These chemical substances are asbestos, 1-BP, carbon
tetrachloride, C.I. Pigment Violet (PV 29), cyclic aliphatic bromide
cluster (HBCD), 1,4-dioxane, methylene chloride, n-methylpyrrolidone
(NMP), perchloroethylene (PCE), and trichloroethylene (TCE).
From June 2020 to January 2021, EPA published risk evaluations on
the first ten chemical substances, including for 1-BP in August 2020.
The risk evaluations included individual unreasonable risk
determinations for each condition of use evaluated. EPA issued
determinations that particular conditions of use did not present an
unreasonable risk by order under TSCA section 6(i)(1).
In accordance with Executive Order 13990 (Ref. 3) and other
Administration priorities (Refs. 4, 5, and 6), EPA reviewed the risk
evaluations for the first ten chemical substances, including 1-BP, to
ensure that they meet the requirements of TSCA, including conducting
decision making in a manner that is consistent with the best available
science.
As a result of this review, EPA announced plans to revise specific
aspects of the first ten risk evaluations in order to ensure that the
risk evaluations appropriately identify unreasonable risks and thereby
help ensure the protection of human health and the environment (Ref.
7). To that end, EPA is reconsidering two key aspects of the risk
determinations for 1-BP published in August 2020. First, following a
review of specific aspects of the August 2020 1-BP risk evaluation, EPA
proposes that making an unreasonable risk determination for 1-BP as a
whole chemical substance, rather than making unreasonable risk
determinations separately on each individual condition of use evaluated
in the risk evaluation, is the most appropriate approach to 1-BP under
the statute and implementing regulations. Second, EPA proposes that the
risk determination should be explicit that it does not rely on
assumptions regarding the use of personal protective equipment (PPE) in
making the unreasonable risk determination under TSCA section 6, even
though some facilities might be using PPE as one means to reduce
workers exposures; rather, the use of PPE would be considered during
risk management as appropriate.
Separately EPA is conducting a screening approach to assess
potential risks from pathways excluded from evaluation for several of
the first 10 chemicals, including this chemical. For 1-BP, the air
exposure pathway was not fully assessed in the final risk evaluation
(see section 1.4.2 of the August 2020 1-BP risk evaluation). The goal
of the recently-developed screening approach is to remedy this
exclusion and to identify if there are risks that were unaccounted for
in the 1-BP risk evaluation. While this analysis is underway, EPA is
not incorporating the screening-level approach into this draft revised
unreasonable risk determination. If the results suggest there is
additional risk, EPA will determine if the risk management approaches
being contemplated for 1-BP will protect against these risks or if the
risk evaluation will need to be formally supplemented or revised.
This action pertains only to the risk determination for 1-BP. While
EPA intends to consider and may take additional similar actions on
other of the first ten chemicals, EPA is taking a chemical-specific
approach to reviewing the risk evaluations and is incorporating new
policy direction in a surgical manner, while being mindful of the
Congressional direction on the need to complete risk evaluations and
move toward any associated risk management activities in accordance
with statutory deadlines.
B. What is a whole chemical view of the unreasonable risk determination
for the 1-BP 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
[[Page 43267]]
comprehensive for the chemical substance after considering the
conditions of use, referred to as a whole-chemical determination; or
multiple determinations, each of which is specific to a condition of
use, referred to as condition-of-use-specific determinations.
The proposed risk evaluation procedural rule was premised on the
whole chemical approach to making an unreasonable risk determination
(Ref. 8). In that proposed rule, EPA acknowledged a lack of specificity
in statutory text that might lead to different views about whether the
statute compelled EPA's risk evaluations to address all conditions of
use of a chemical substance or whether EPA had discretion to evaluate
some subset of conditions of use (i.e., to scope out some
manufacturing, processing, distribution in commerce, use, or disposal
activities), but also stated that ``EPA believes the word `the' (in
TSCA section 6(b)(4)(A)) is best interpreted as calling for evaluation
that considers all conditions of use.'' (Ref. 8).
The proposed rule, however, was unambiguous on the point that an
unreasonable risk determination would be for the chemical substance as
a whole, even if based on a subset of uses. (See Ref. 8 at pgs. 7565-
66: ``TSCA section 6(b)(4)(A) specifies that a risk evaluation must
determine whether `a chemical substance' presents an unreasonable risk
of injury to health or the environment `under the conditions of use.'
The evaluation is on the chemical substance--not individual conditions
of use--and it must be based on `the conditions of use.' In this
context, EPA believes the word `the' is best interpreted as calling for
evaluation that considers all conditions of use.''). In the proposed
regulatory text, EPA proposed to determine whether the chemical
substance presents an unreasonable risk of injury to health or the
environment under the conditions of use. (Ref. 8 at pg. 7480).
The final risk evaluation procedural rule stated (82 FR 33726, July
20, 2017) (FRL-9964-38) (Ref. 9): ``As part of the risk evaluation, EPA
will determine whether the chemical substance presents an unreasonable
risk of injury to health or the environment under each condition of
uses [sic] within the scope of the risk evaluation, either in a single
decision document or in multiple decision documents.'' (See also 40 CFR
702.47). For the unreasonable risk determinations in the first ten risk
evaluations, EPA applied this provision by making individual risk
determinations for each condition of use evaluated in each risk
evaluation (i.e., the condition-of-use-specific approach to risk
determinations). That approach was based on one particular passage in
the preamble to the final risk evaluation procedural rule, which stated
that EPA will make individual risk determinations for all conditions of
use identified in the scope (Ref. 9 at pg. 33744).
In contrast to this portion of the preamble of the final risk
evaluation procedural rule, the regulatory text itself and other
statements in the preamble reference a risk determination for the
chemical substance under its conditions of use, rather than separate
risk determinations for each of the conditions of use of a chemical
substance. In the key regulatory provision excerpted earlier from 40
CFR 702.47, the text explains that, ``[a]s part of the risk evaluation,
EPA will determine whether the chemical substance presents an
unreasonable risk of injury to health or the environment under each
condition of uses [sic] within the scope of the risk evaluation, either
in a single decision document or in multiple decision documents'' (Ref.
9, emphasis added). Other language reiterates this perspective. For
example, 40 CFR 702.31(a) states that the purpose of the rule is to
establish the EPA process for conducting a risk evaluation to determine
whether a chemical substance presents an unreasonable risk of injury to
health or the environment as required under TSCA section 6(b)(4)(B).
Likewise, there are recurring references to whether the chemical
substance presents an unreasonable risk in 40 CFR 702.41(a). See, for
example, 40 CFR 702.41(a)(6), which explains that the extent to which
EPA will refine its evaluations for one or more condition of use in any
risk evaluation will vary as necessary to determine whether a chemical
substance presents an unreasonable risk. Notwithstanding the one
preambular statement about condition-of-use-specific risk
determinations, the preamble to the final rule also contains support
for a risk determination on the chemical substance as a whole. In
discussing the identification of the conditions of use of a chemical
substance, the preamble notes that this task inevitably involves the
exercise of discretion on EPA's part, and, ``as EPA interprets the
statute, the Agency is to exercise that discretion consistent with the
objective of conducting a technically sound, manageable evaluation to
determine whether a chemical substance--not just individual uses or
activities--presents an unreasonable risk.'' (Ref. 8 at pg. 33729).
Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk
evaluation regulation to also allow the Agency to issue whole-chemical
risk determinations. Either approach is permissible under the
regulation. A panel of the Ninth Circuit Court of Appeals also
recognized the ambiguity of the regulation on this point. Safer
Chemicals v. EPA, 943 F.3d 397, 413 (9th Cir. 2019) (holding a
challenge about ``use-by-use risk evaluations [was] not justiciable
because it is not clear, due to the ambiguous text of the Risk
Evaluation Rule, whether the Agency will actually conduct risk
evaluations in the manner Petitioners fear'').
EPA plans to consider the appropriate approach for each chemical
substance risk evaluation on a case-by-case basis, taking into account
considerations relevant to the specific chemical substance in light of
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's
ability to evaluate and manage unreasonable risk from individual
chemical substances. EPA believes this is a reasonable approach under
TSCA and the Agency's implementing regulations.
With regard to the specific circumstances of 1-BP, as further
explained in this notice, EPA proposes that a whole chemical approach
is appropriate for 1-BP in order to protect human health and the
environment. The whole chemical approach is appropriate for 1-BP
because there are benchmark exceedances for multiple conditions of use
(spanning across most aspects of the chemical lifecycle--from
manufacturing (including import), processing, commercial and industrial
use, consumer use, and disposal) for health of workers, occupational
non-users, consumers, and bystanders and the irreversible health
effects (specifically developmental toxicity and cancer) associated
with 1-BP 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 1-BP that the whole chemical presents an unreasonable
risk.
As explained later in this document, the revisions to the
unreasonable risk determination (section 5 of the risk evaluation)
would be based on the existing risk characterization section of the
risk evaluation (section 4 of the risk evaluation) and would not
involve
[[Page 43268]]
additional technical or scientific analysis. The discussion of the
issues presented in this Federal Register notice and in the
accompanying draft revision to the risk determination would supersede
any conflicting statements in the prior 1-BP risk evaluation and the
response to comments document (Ref. 10). With respect to the 1-BP risk
evaluation, EPA intends to change the risk determination to a whole
chemical approach without considering the use of PPE and does not
intend to amend, nor does a whole chemical approach require amending,
the underlying scientific analysis of the risk evaluation in the risk
characterization section of the risk evaluation. EPA views the peer
reviewed hazard and exposure assessments and associated risk
characterization as robust and upholding the standards of best
available science and weight of the scientific evidence per TSCA
sections 26(h) and (i).
EPA is announcing the availability of and seeking public comment on
the draft superseding unreasonable risk determination for 1-BP,
including a description of the risks driving the unreasonable risk
determination under the condition of use for the chemical substance as
a whole. For purposes of TSCA section 6(i), EPA is making a draft risk
determination on 1-BP as a whole chemical. Under the proposed revised
approach, the ``whole chemical'' risk determination for 1-BP would
supersede the no unreasonable risk determinations for 1-BP that were
premised on a condition-of-use-specific approach to determining
unreasonable risk. When finalized, EPA's revised unreasonable risk
determination would also contain an order withdrawing the TSCA section
6(i)(1) order in section 5.4.1 of the August 2020 1-BP risk evaluation.
C. What revision does EPA propose about the use of PPE for the 1-BP
risk evaluation?
In the risk evaluations for the first ten chemical substances, as
part of the unreasonable risk determination, EPA assumed for several
conditions of use that all workers were provided and always used PPE in
a manner that achieves the stated assigned protection factor (APF) for
respiratory protection, or used impervious gloves for dermal
protection. In support of this assumption, EPA considered reasonably
available information such as public comments indicating that some
employers, particularly in the industrial setting, provide PPE to their
employees and follow established worker protection standards (e.g.,
Occupational Safety and Health Administration (OSHA) requirements for
protection of workers).
For the August 2020 1-BP risk evaluation, EPA assumed based on
reasonably available information that workers use PPE--specifically,
respirators with an APF of 10 or 50, or gloves with a protection factor
(PF) of 5--for 15 of 16 occupational conditions of use. However, in the
August 2020 1-BP risk evaluation, EPA determined that there is
unreasonable risk for nine of these occupational conditions of use even
with this assumed PPE use.
EPA is revising the assumption for 1-BP that workers always or
properly use PPE, although it does not question the public comments
received regarding the occupational safety practices often followed by
industry respondents. When characterizing the risk to human health from
occupational exposures during risk evaluation under TSCA, EPA believes
it is appropriate to evaluate the levels of risk present in baseline
scenarios where PPE is not assumed to be used by workers. This approach
of not assuming PPE use by workers considers the risk to potentially
exposed or susceptible subpopulations (workers and occupational non-
users) who may not be covered by OSHA standards, such as self-employed
individuals and public sector workers who are not covered by a State
Plan. It should be noted that, in some cases, baseline conditions may
reflect certain mitigation measures, such as engineering controls, in
instances where exposure estimates are based on monitoring data at
facilities that have engineering controls in place.
In addition, EPA believes it is appropriate to evaluate the levels
of risk present in scenarios considering applicable OSHA requirements
(e.g., chemical-specific permissible exposure limits (PELs) and/or
chemical-specific PELs with additional substance-specific standards) as
well as scenarios considering industry or sector best practices for
industrial hygiene that are clearly articulated to the Agency.
Consistent with this approach, the August 2020 1-BP risk evaluation
characterized risk to workers both with and without the use of PPE. By
characterizing risks using scenarios that reflect different levels of
mitigation, EPA risk evaluations can help inform potential risk
management actions by providing information that could be used during
risk management to tailor risk mitigation appropriately to address any
unreasonable risk identified, or to ensure that applicable OSHA
requirements or industry or sector best practices that address the
unreasonable risk are required for all potentially exposed or
susceptible subpopulations (including self-employed individuals and
public sector workers who are not covered by an OSHA State Plan).
When undertaking unreasonable risk determinations as part of TSCA
risk evaluations, however, EPA does not believe it is appropriate to
assume as a general matter that an applicable OSHA requirement or
industry practices related to PPE use is consistently and always
properly applied. Mitigation scenarios included in the EPA risk
evaluation (e.g., scenarios considering use of various PPE) likely
represent what is happening already in some facilities. However, the
Agency cannot assume that all facilities have adopted these practices
for the purposes of making the TSCA risk determination.
Therefore, EPA proposes to make a determination of unreasonable
risk for 1-BP 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. EPA
understands that there could be occupational safety protections in
place at workplace locations; however, not assuming use of PPE reflects
EPA's recognition that unreasonable risk may exist for subpopulations
of workers that may be highly exposed because they are not covered by
OSHA standards, 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 OSHA has not
issued a permissible exposure limit (PEL) (as is the case for 1-BP,
noting that many of OSHA's chemical-specific permissible exposure
limits largely adopted in the 1970's are described by OSHA as being
``outdated and inadequate for ensuring protection of worker health''
(Ref. 11), or because EPA finds unreasonable risk for purposes of TSCA
notwithstanding OSHA requirements.
In accordance with this approach, EPA is proposing the draft
revision to the 1-BP risk determination without relying on assumptions
regarding the occupational use of PPE in making the unreasonable risk
determination under TSCA section 6; rather, information on the use of
PPE as a means of mitigating risk (including information received from
industry respondents about
[[Page 43269]]
occupational safety practices in use) would be considered during the
risk management phase as appropriate. This would represent a change
from the approach taken in the 2020 risk evaluation for 1-BP and EPA
invites comments on this draft change to the 1-BP risk determination.
As a general matter, when undertaking risk management actions, EPA
intends to strive for consistency with applicable OSHA requirements and
industry best practices, including appropriate application of the
hierarchy of controls, when those measures would address an identified
unreasonable risk, including unreasonable risk to potentially exposed
or susceptible subpopulations. Consistent with TSCA section 9(d), EPA
will consult and coordinate TSCA activities with OSHA and other
relevant Federal agencies for the purpose of achieving the maximum
applicability of TSCA while avoiding the imposition of duplicative
requirements. Informed by the mitigation scenarios and information
gathered during the risk evaluation and risk management process, the
Agency might propose rules that require risk management practices that
may be already common practice in many or most facilities. Adopting
clear, comprehensive regulatory standards will foster compliance across
all facilities (ensuring a level playing field) and assure protections
for all affected workers, especially in cases where current OSHA
standards may not apply or be sufficient to address the unreasonable
risk.
Removing the assumption that workers always and appropriately use
PPE in making the whole chemical risk determination for 1-BP would add
seven conditions of use to the original 16 conditions of use that drive
the unreasonable risk. The seven conditions of use affected by this
change are: manufacturing (domestic manufacturing); manufacturing
(import); processing: as a reactant; processing: incorporation into
articles; processing: repackaging; processing: recycling; and disposal.
Additionally, removing this assumption would add: additional risks of
cancer from dermal exposures as driving the unreasonable risk to
workers in six conditions of use; additional risks for acute and
chronic non-cancer effects from inhalation exposures as driving the
unreasonable risk to workers in two conditions of use; and additional
risks for acute and chronic non-cancer effects and cancer from
inhalation and dermal exposures to workers as driving the unreasonable
risk in one conditions of use (where previously this condition of use
was identified as presenting unreasonable risk only to ONUs) (Ref. 1).
The draft revision to the risk determination would clarify that EPA
does not rely on the assumed use of PPE when making the risk
determination for the whole substance. EPA is requesting comment on
this potential change.
D. What is 1-BP?
1-BP is a colorless liquid with a sweet odor. It is a brominated
hydrocarbon that is slightly soluble in water. 1-BP is a volatile
organic compound that exhibits high volatility, a low boiling point,
low flammability and no explosivity. 1-BP is produced and imported in
the United States and has a wide range of uses, including as a solvent
in degreasing operations, spray adhesives and dry cleaning; as a
reactant in the manufacturing of other chemical substances; and in
laboratory uses. There are also a variety of consumer and commercial
products that contain 1-BP, such as aerosol degreasers, spot cleaners,
stain removers, and insulation for building and construction materials.
The total aggregate production volume reported for 1-BP under the
Chemical Data Reporting rule ranged from 15.4 million to 25.8 million
pounds between 2012 and 2015.
E. What conclusions did EPA reach about the risks of 1-BP in the 2020
TSCA risk evaluation and what conclusions is EPA proposing to reach
based on the whole chemical approach and not assuming the use of PPE?
In the 2020 risk evaluation, EPA determined that 1-BP presents an
unreasonable risk to health under the following conditions of use:
Processing for incorporation into formulation, mixture or
reaction product
Industrial and commercial use as solvent for cleaning and
degreasing in vapor degreaser (batch vapor degreaser--open-top, inline
vapor degreaser)
Industrial and commercial use as solvent for cleaning and
degreasing in vapor degreaser (batch vapor degreaser--closed-loop)
Industrial and commercial use as solvent for cleaning and
degreasing in cold cleaners
Industrial and commercial use as solvent in aerosol spray
degreaser/cleaner
Industrial and commercial use in adhesives and sealants
Industrial and commercial use in dry cleaning solvents,
spot cleaners and stain removers
Industrial and commercial use in liquid cleaners (e.g.,
coin and scissor cleaner) and liquid spray/aerosol cleaners
Other industrial and commercial uses: arts, crafts, hobby
materials (adhesives accelerant); automotive care products (engine
degrease, brake cleaner, refrigerant flush); anti-adhesive agents (mold
cleaning and release product); electronic and electronic products and
metal products; functional fluids (close/open-systems)--refrigerant/
cutting oils; asphalt extraction; laboratory chemicals; and temperature
indicator--coatings
Consumer use as solvent in aerosol spray degreasers/
cleaners
Consumer use in spot cleaners and stain removers
Consumer use in liquid cleaners (e.g., coin and scissor
cleaners)
Consumer use in liquid spray/aerosol cleaners
Consumer use in arts, crafts, hobby materials (adhesive
accelerant)
Consumer use in automotive care products (refrigerant
flush)
Consumer use in anti-adhesives agents (mold cleaning and
release product)
Under the proposed whole chemical approach to the 1-BP risk
determination, the unreasonable risk from 1-BP would continue to be
driven by risk from those same conditions of use. In addition, by
removing the assumption that workers always and appropriately wear PPE
(see Unit II.C.) in making the whole chemical risk determination for 1-
BP, seven conditions of use in addition to the original 16 would drive
the draft unreasonable risk determination:
Manufacture (domestic manufacturing)
Manufacture (import)
Processing as a reactant
Processing for incorporation into articles
Processing by repackaging
Recycling
Disposal
Overall, 23 conditions of use out of the 25 EPA evaluated would
drive the 1-BP whole chemical unreasonable risk determination.
III. Revision of the August 2020 Risk Evaluation
A. Why is EPA proposing to revise the risk determination for the 1-BP
risk evaluation?
EPA is proposing to revise the risk determination for the 1-BP 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
[[Page 43270]]
(Refs. 3, 4, and 6). EPA is revising specific aspects of the first ten
TSCA existing chemical risk evaluations in order to ensure that the
risk evaluations better align with TSCA's objective of protecting
health and the environment. For the 1-BP risk evaluation, this includes
the draft revision: (1) making the risk determination in this instance
based on the whole chemical substance instead of by individual
conditions of use and (2) emphasizing that EPA does not rely on the
assumed use of PPE when making the risk determination.
B. What are the draft revisions?
EPA is releasing a draft revision of the risk determination for the
1-BP risk evaluation pursuant to TSCA section 6(b). Under the revised
determination, EPA preliminarily concludes that 1-BP, as evaluated in
the risk evaluation as a whole, presents an unreasonable risk of injury
to health under its conditions of use. This revision would replace the
previous unreasonable risk determinations made for 1-BP by individual
conditions of use, supersede the determinations (and withdraw the
associated order) of no unreasonable risk for the conditions of use
identified the TSCA section 6(i)(1) no unreasonable risk order, and
clarify the lack of reliance on assumed use of PPE as part of the risk
determination.
These draft revisions do not alter any of the underlying technical
or scientific information that informs the risk characterization, and
as such the hazard, exposure, and risk characterization sections are
not changed except to the extent that statements about PPE assumptions
in section 2.3.1.3 (Consideration of Engineering Controls and PPE) and
section 4.2.2 (Occupational Inhalation Exposure Summary and PPE Use
Determinations by OES) of the 1-BP risk evaluation would be superseded.
The discussion of the issues in this notice and in the accompanying
draft revision to the risk determination would supersede any
conflicting statements in the prior executive summary and sections
2.3.1.3 and 4.2.2 from the 1-BP risk evaluation and the response to
comments document (Refs. 2 and 10). Additional policy changes to other
chemical risk evaluations, including any consideration of potentially
exposed and susceptible subpopulations and/or inclusion of additional
exposure pathways, are not necessarily reflected in these draft
revisions to the risk determination.
C. Will the draft revised risk determination be peer reviewed?
The risk determination (section 5 in the August 2020 risk
evaluation) was not part of the scope of the peer reviews of the 1-BP
risk evaluation by the Science Advisory Committee on Chemicals (SACC).
Thus, consistent with that approach, EPA does not intend to conduct
peer review of the draft revised unreasonable risk determination for
the 1-BP risk evaluation because no technical or scientific changes
will be made to the hazard or exposure assessments or the risk
characterization.
D. What are the next steps for finalizing revisions to the risk
determination?
EPA will review and consider public comment received on the draft
revised risk determination for the 1-BP risk evaluation and, after
considering those public comments, issue the revised final 1-BP risk
determination. If finalized as drafted, EPA would also issue a new
order to withdraw the TSCA section 6(i)(1) no unreasonable risk order
issued in Section 5.4.1 of the 2020 1-BP risk evaluation. This final
revised risk determination would supersede the August 2020 risk
determinations of no unreasonable risk. Consistent with the statutory
requirements of TSCA section 6(a), the Agency would then propose risk
management actions to address the unreasonable risk determined in the
1-BP risk evaluation.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA Draft Revised Unreasonable Risk Determination for 1-
Bromopropane, Section 5, July 2022.
2. EPA Risk Evaluation for 1-Bromopropane. EPA Document #740-R1-
8013. August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0235-0085
3. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register. 86 FR 7037, January 25, 2021.
4. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register. 86 FR 7009, January 25, 2021.
5. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
6. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register. 86 FR 8845, February 10, 2021.
7. EPA Press Release. EPA Announces Path Forward for TSCA Chemical
Risk Evaluations. June 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register. 82 FR
7562, January 19, 2017 (FRL-9957-75).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under
the Amended Toxic Substances Control Act. Federal Register. 82 FR
33726, July 20, 2017 (FRL-9964-38).
10. EPA. Summary of External Peer Review and Public Comments and
Disposition for 1-Bromopropane (1-BP). August 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0235-0066.
11. Occupational Safety and Health Administration. Permissible
Exposure Limits--Annotated Tables. Accessed June 13, 2022. https://www.osha.gov/annotated-pels.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 14, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-15516 Filed 7-19-22; 8:45 am]
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