Notice2021-28231
Cyclic Aliphatic Bromide Cluster (HBCD); Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2021
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and requesting public comment on a draft revision to the risk determination for the Cyclic Aliphatic Bromide Cluster (HBCD) risk evaluation issued under TSCA. The draft revision to the HBCD risk determination was developed following a review of the first ten risk evaluations issued under TSCA that was done in accordance with Executive Orders and other Administration priorities, including those on environmental justice, scientific integrity, and regulatory review, and this draft revision 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. Specifically, in this draft revision to the risk determination EPA finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use. This draft revision supersedes the condition of use-specific no unreasonable risk determinations in the September 2020 HBCD risk evaluation (and withdraw the associated order) and makes a revised determination of unreasonable risk for HBCD as a whole chemical substance. In addition, this draft revised risk determination does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE).
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 247 (Wednesday, December 29, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74082-74088]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28231]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0237; FRL-9283-01-OCSPP]
Cyclic Aliphatic Bromide Cluster (HBCD); Draft Revision to Toxic
Substances Control Act (TSCA) Risk Determination; Notice of
Availability and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and requesting public comment on a draft revision to
the risk determination for the Cyclic Aliphatic Bromide Cluster (HBCD)
risk evaluation issued under TSCA. The draft revision to the HBCD risk
determination was developed following a review of the first ten risk
evaluations issued under TSCA that was done in accordance with
Executive Orders and other Administration priorities, including those
on environmental justice, scientific integrity, and regulatory review,
and this draft revision 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. Specifically, in this draft
revision to the risk determination EPA finds that HBCD, as a whole
chemical substance, presents an unreasonable risk of injury to health
and the environment when evaluated under its conditions of use. This
draft revision supersedes the condition of use-specific no unreasonable
risk determinations in the September 2020 HBCD risk evaluation (and
withdraw the associated order) and makes a revised determination of
unreasonable risk for HBCD as a whole chemical substance. In addition,
this draft revised risk determination does not reflect an assumption
that workers always appropriately wear personal protective equipment
(PPE).
DATES: Comments must be received on or before February 14, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0237, using the Federal eRulemaking Portal
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 or 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>.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Sarah Cox, Office of Pollution Prevention and Toxics (7404T),
Environmental
[[Page 74083]]
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-3961; email address:
<a href="/cdn-cgi/l/email-protection#63200c1b4d300211020b230613024d040c15"><span class="__cf_email__" data-cfemail="3a79554214695b485b527a5f4a5b145d554c">[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#70242333315d381f041c191e15301500115e171f06"><span class="__cf_email__" data-cfemail="82d6d1c1c3afcaedf6eeebece7c2e7f2e3ace5edf4">[email protected]</span></a>.
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 HBCD, including HBCD in products. Since other
entities may also be interested in this draft revision to the risk
determination, the 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
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 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).
Further, on August 10, 2021, the Ninth Circuit granted EPA's motion for
voluntary remand without vacatur, so that EPA may conduct
reconsideration proceedings on the HBCD Risk Evaluation-particularly to
reconsider the no unreasonable risk determinations made within. Alaska
Community Action on Toxics at al., v. U.S. Environmental Protection
Agency et al., (9th Cir. No. 20-73099).
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
HBCD under TSCA, published in September 2020. EPA is specifically
seeking public comment on the draft revision to the risk determination
for the risk evaluation where the Agency intends to determine if HBCD,
as a whole chemical substance, presents an unreasonable risk of injury
to health and the environment when evaluated under its conditions of
use. This whole chemical approach to determining unreasonable risk to
health is permissible under EPA's statutory obligations under TSCA
section 6(b)(4) and the implementing regulations and would revise and
replace section 5 of the 2020 risk evaluation for HBCD where the
findings of unreasonable risk to health and the environment were
previously made for the individual conditions of use evaluated.
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 proposed
changes, the same six conditions of use would continue to drive the
unreasonable risk determination for HBCD. However, the impact of
removing the assumption of PPE use by workers would cause four of the
six conditions of use that drive the unreasonable risk determination
based on only risks to the environment to also drive unreasonable risk
based on health risks to workers. The four conditions of use affected
by this proposed change are: Import; Processing: Incorporation into
formulation, mixture, or reaction products; Processing: Incorporation
into articles; and Processing: Recycling (of XPS and EPS foam, resin,
panels containing HBCD). Overall, six conditions of use would drive the
HBCD whole chemical unreasonable risk determination due to risks
identified for both the environment and health. The full list of the
conditions of use evaluated for the HBCD TSCA risk evaluation is in
Table 8-1 of the risk evaluation available here <a href="https://www.epa.gov/sites/default/files/2020-09/documents/1._risk_evaluation_for_cyclic_aliphatic_bromide_cluster_hbcd_casrn25637-99-4_casrn_3194-5_casrn_3194-57-8.pdf">https://www.epa.gov/sites/default/files/2020-09/documents/1._risk_evaluation_for_cyclic_aliphatic_bromide_cluster_hbcd_casrn25637-99-4_casrn_3194-5_casrn_3194-57-8.pdf</a>.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> 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
[[Page 74084]]
comments, see the commenting tips at <a href="http://www.epa.gov/dockets/comments.html">http://www.epa.gov/dockets/comments.html</a>.
II. Background
A. Why is EPA re-issuing the risk determination for the HBCD 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-bromopropane,
carbon tetrachloride, C.I. Pigment Violet 29, 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 HBCD in September
2020. The risk evaluations included individual unreasonable risk
determinations for each condition of use evaluated. The determinations
that particular conditions of use did not present an unreasonable risk
were issued by order under TSCA section 6(i)(1).
In accordance with Executive Order 13990 (Ref. 2) and other
Administration priorities (Refs. 1, 3, and 4), EPA reviewed the risk
evaluations for the first ten chemical substances 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
available here <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>. To that end, EPA is
reconsidering two key aspects of the risk determinations for HBCD
published in September 2020. First, EPA proposes that the appropriate
approach to these determinations under the statute and implementing
regulations is to make an unreasonable risk determination for HBCD as a
whole chemical substance, rather than making unreasonable risk
determinations separately on each individual condition of use evaluated
in the risk evaluation. 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; rather, the use
of PPE would be considered during risk management.
This action pertains only to the risk determination for HBCD. 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. To the extent the Agency deems appropriate,
additional actions may follow that are specific to each of the other
chemical substances for which EPA has issued completed risk evaluations
under TSCA section 6.
B. What is a whole chemical view of the unreasonable risk determination
for the HBCD 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. EPA acknowledges a lack of specificity in the
statute and inconsistency in the regulations with respect to the
presentation of risk determinations in TSCA risk evaluations.
The proposed Risk Evaluation Rule (Ref. 5), was premised on the
whole chemical approach to making unreasonable risk determinations. EPA
acknowledged a lack of specificity in 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). 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. 5 at 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 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
as identified in the final scope document . . .'' Ref. 5 at 7480.
As stated in the final Risk Evaluation Rule (82 FR 33726, July 20,
2017) (FRL-9964-38) (Ref. 6): 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: The final step of a
risk evaluation is for EPA to determine whether the chemical substance,
under the conditions of use, presents an unreasonable risk of injury to
health or the environment. EPA will make individual risk determinations
for all uses identified in the scope. This part of the regulation is
slightly amended from the proposed rule, to clarify that the risk
determination is part of the risk evaluation, as well as to account for
the revised approach to that [sic] ensures each condition of use
covered by the risk evaluation receives a risk determination. (Ref. 6
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
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
[[Page 74085]]
document or in multiple decision documents (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
states: [t]he 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
of injury to health or the environment. 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. 6 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. For
instance, circumstances in which an unreasonable risk determination is
primarily driven by a single condition of use that does not impact or
intersect with other evaluated uses (such as for example, a single
consumer use of a substance out of a wide range of other manufacturing,
processing and consumer uses evaluated) may warrant different treatment
than circumstances in which the majority of the chemical substance's
conditions of use contribute to unreasonable risk, and the Agency might
adopt different approaches to the risk determinations in those
particular instances. EPA anticipates that this flexibility will better
serve TSCA's objectives by helping ensure that EPA is best positioned
to present, and initiate risk management to address, chemical-specific
unreasonable risk determinations. EPA believes this is a reasonable
approach under TSCA and the Agency's implementing regulations.
With regard to the specific circumstances of HBCD, as further
explained in this document, EPA proposes that a whole chemical approach
better aligns with TSCA's objective of protecting health and the
environment. For HBCD, EPA favors the whole chemical approach based in
part on the benchmark exceedances for multiple conditions of use
(spanning across most aspects of the chemical lifecycle--from
manufacturing (import), processing, commercial and consumer use, and
disposal) for both health and the environment and considering the
physical-chemical properties of HBCD as a persistent, bioaccumulative
and toxic substance, and the irreversible health effects associated
with HBCD exposures. Since the chemical-specific properties cut across
the conditions of use within the scope of the risk evaluation, the
Agency's risk findings and conclusions encompass the majority of those
conditions of use, and the Agency is better positioned to achieve its
TSCA objectives for HBCD when issuing a whole chemical determination
for HBCD, EPA concludes that the Agency's risk determination for HBCD
is better characterized as a whole chemical risk determination rather
than condition-of-use-specific risk determinations.
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 additional technical or scientific analysis. The discussion of
the issues in this Federal Register Notice and in the accompanying
draft revision to the risk determination would supersede any
conflicting statements in the prior HBCD risk evaluation and the
response to comments document (Summary of External Peer Review and
Public Comments and Disposition for HBCD). With respect to the HBCD
risk evaluation, EPA intends to change the risk determination to a
whole chemical approach 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 also 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 soliciting public comment
on the draft superseding unreasonable risk determination for HBCD,
including a list of the condition-of-use-specific risks driving the
unreasonable risk determination for the chemical substance as a whole.
For purposes of TSCA section 6(i), EPA is making a risk determination
on HBCD as a whole chemical. Under the revised approach, EPA is
proposing to supersede the no unreasonable risk determinations (and
withdraw the associated order) for HBCD that were premised on a
condition-of-use-specific approach to determining unreasonable risk.
C. What revision does EPA propose about the use of PPE for the HBCD
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 protection factor (PF) 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.,
Occupational Safety and Health Administration (OSHA) requirements for
protection of workers).
For the September 2020 HBCD risk evaluation, EPA assumed that
workers
[[Page 74086]]
used PPE for six of the twelve conditions of use:
<bullet> Import;
<bullet> Processing: Incorporating into formulation, mixture, or
reaction products;
<bullet> Processing: Incorporation into article;
<bullet> Processing: Recycling (of XPS and EPS foam, resin, panels
containing HBCD);
<bullet> Processing: Recycling (of electronics waste containing
high impact polystyrene (HIPS) that contains HBCD); and
<bullet> Commercial/Consumer Use: Other--Formulated Products and
Articles
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 no mitigation measures are assumed to be in place. This
approach 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. 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. 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. Consistent with
this approach, the September 2020 HBCD risk evaluation characterized
risk to workers both with and without the use of PPE.
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 is sufficient to address the risk, applicable to all
potentially exposed workers, or 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. Additionally, as
previously noted, self-employed individuals and public sector workers
who are not covered by a State Plan are not covered by OSHA
requirements. 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.
Therefore, going forward, EPA intends to make its determination of
unreasonable risk 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 EPA
finds unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements.
In accordance with this approach, EPA proposes that the draft
revision to the HBCD risk determination not rely on assumptions
regarding the occupational use of PPE in making the unreasonable risk
determination under TSCA section 6; rather, the use of PPE would be
considered during risk management. This would represent a change from
the approach taken in the 2020 risk evaluation for HBCD and EPA invites
comments on this proposed change to the HBCD 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
unreasonable risk; ensure the EPA requirements apply to all potentially
exposed workers; and develop occupational risk mitigation measures to
address any unreasonable risks identified by EPA. 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.
By removing the assumption of PPE use in making the whole chemical
risk determination for HBCD the same six conditions of use would
continue to drive the proposed unreasonable risk determination.
However, the impact of removing the assumption of PPE use would cause
four of the six conditions of use that drive the unreasonable risk
determination based on only risks to the environment to also drive
unreasonable risk based on health risks to workers. The four conditions
of use affected by this change are:
<bullet> Import;
<bullet> Processing: Incorporation into formulation, mixture, or
reaction products;
<bullet> Processing: Incorporation into article; and
<bullet> Processing: Recycling (of XPS and EPS foam, resin, panels
containing HBCD).
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 HBCD?
HBCD is a white odorless non-volatile solid that is used as a flame
retardant and wetting agent. Domestic manufacture of HBCD ceased in
2017 and was therefore not considered as a condition of use for the
risk evaluation. U.S. manufacturers have indicated complete replacement
of HBCD in their product lines and that depletion of stockpiles and
cessation of export was completed in 2017 based on communications with
manufacturers. HBCD has also not been imported by any major importers
since 2017; however, it is reasonably foreseen that small imports under
the Chemical Data Reporting threshold may have
[[Page 74087]]
continued from countries that were not parties to the Stockholm
Convention ban. About 95% of HBCD was historically used in insulation
boards, primarily in construction materials, which may include
structural insulated panels (SIPS). The category ``Building/
Construction Materials'' includes products containing HBCD as a flame
retardant primarily in XPS and EPS rigid foam insulation products that
are used for the construction of residential, public, commercial, or
other structures. HBCD is added to EPS and XPS foam in the form of a
resin. EPS foam prevents freezing, provides a stable fill material, and
creates high-strength composites in construction applications. XPS foam
board is used mainly for roofing applications and architectural
molding. Minor uses of HBCD include replacement car parts (polystyrene
headliners and solder) and solder paste for electronics (circuit
boards). Historically, HBCD was also manufactured (including import)
and processed for additional articles that may still exist, including
adhesives, coatings, sealants, textiles, and electronics.
E. What conclusions did EPA reach about the risks of HBCD in the TSCA
risk evaluation based on the whole chemical approach and not assuming
the use of PPE?
EPA determined that HBCD presents an unreasonable risk to health
and the environment and the unreasonable risk is driven by risks
associated with the following conditions of use, considered singularly
or in combination with other exposures:
<bullet> Import;
<bullet> Processing: Incorporation into a Formulation, Mixture, or
Reaction Products;
<bullet> Processing: Incorporation into Article;
<bullet> Processing: Recycling (of XPS and EPS foam, resin, and
panels containing HBCD);
<bullet> Commercial/Consumer Use: Building/Construction Materials
(Installation); and
<bullet> Disposal (Demolition).
Note: While commercial and consumer use was assessed as part of the
same exposure scenario, risks were quantified separately, and consumer
use was not found to contribute to unreasonable risk (Executive Summary
of the Risk Evaluation).
III. Revision of the September 2020 Risk Evaluation
A. Why is EPA proposing to revise the risk determination for the HBCD
risk evaluation?
EPA is proposing to revise the risk determination for the HBCD risk
evaluation pursuant to TSCA section 6(b) and consistent with Executive
Order 13990, (Ref 2) and other Administration priorities (Refs. 1, 3,
and 4). EPA plans to consider 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 HBCD risk evaluation, this includes
the proposed revisions: (1) Making the risk determination in this
instance based on the whole chemical approach 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
HBCD Risk Evaluation pursuant to TSCA section 6(b). Under the revised
determination, EPA proposes to conclude that HBCD, as evaluated in the
risk evaluation as a whole, presents an unreasonable risk of injury to
health and environment when evaluated under its conditions of use. This
revision would replace the previous unreasonable risk determinations
made for HBCD by individual conditions of use, supersede the
determinations (and withdraw the associated order) of no unreasonable
risk for the conditions of use identified in the 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. 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 from the HBCD
risk evaluation and the response to comments document (Summary of
External Peer Review and Public Comments and Disposition for HBCD).
Additional policy changes to other chemical risk evaluations, including
any proposed 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 of this Risk Evaluation) was not
part of the scope of the Science Advisory Committee on Chemicals (SACC)
peer reviews of the first ten priority chemicals. Thus, consistent with
that approach, EPA does not intend to conduct peer review for the draft
revised unreasonable risk determination for the HBCD 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 HBCD risk evaluation and, after
considering those public comments, issue the revised final HBCD risk
determination. If finalized as proposed, 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 HBCD risk evaluation. This final
revised risk determination would supersede the September 2020 risk
determinations of no unreasonable risk. Consistent with the statutory
requirements of section 6(a), the Agency would then propose risk
management actions to address the unreasonable risk determined in the
HBCD 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. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
2. 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).
3. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad.
[[Page 74088]]
Federal Register (86 FR 7619, February 1, 2021).
4. Presidential Memorandum. Memorandum on Restoring Trust in
Government Through Scientific Integrity and Evidence-Based
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
5. 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).
6. 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).
Authority: 15 U.S.C. 2601 et seq.
Michael S. Regan,
Administrator.
[FR Doc. 2021-28231 Filed 12-28-21; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 29, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.