Notice2022-13805
Cyclic Aliphatic Bromide Cluster (HBCD); Revision to the Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability
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
June 29, 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 Cyclic Aliphatic Bromide Cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). The revision to the HBCD 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 HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment 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 HBCD). This revision supersedes the condition of use-specific no unreasonable risk determinations in the September 2020 HBCD risk evaluation and withdraws the associated order included in section 5.4.1 of the September 2020 HBCD risk evaluation.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 124 (Wednesday, June 29, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38747-38757]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13805]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0237; FRL-9283-03-OCSPP]
Cyclic Aliphatic Bromide Cluster (HBCD); Revision to the Toxic
Substances Control Act (TSCA) Risk Determination; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final revision to the risk determination for the
Cyclic Aliphatic Bromide Cluster (HBCD) risk evaluation issued under
the Toxic Substances Control Act (TSCA). The revision to the HBCD 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 HBCD, as
a whole chemical substance, presents an unreasonable risk of injury to
health and the environment 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
HBCD). This revision supersedes the condition of use-specific no
unreasonable risk determinations in the September 2020 HBCD risk
evaluation and withdraws the associated order included in section 5.4.1
of the September 2020 HBCD risk evaluation.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0237, 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) in the 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
[[Page 38748]]
Public Reading Room is (202) 566-1744, and the telephone number for the
OPPT Docket is (202) 566-0280. Please review the visitor instructions
and additional information about the docket available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Alie Muneer, Office of Pollution
Prevention and Toxics (7404T), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-6369; email address: <a href="/cdn-cgi/l/email-protection#ff928a919a9a8dd19e93969abf9a8f9ed1989089"><span class="__cf_email__" data-cfemail="472a322922223569262b2e220722372669202831">[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#d084839391fd98bfa4bcb9beb590b5a0b1feb7bfa6"><span class="__cf_email__" data-cfemail="7420273735593c1b00181d1a11341104155a131b02">[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 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 HBCD, including HBCD 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). 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 the final revision to the
risk determination for the HBCD risk evaluation issued under TSCA that
published in September 2020. In December 2021, EPA sought public
comment on the draft revisions (86 FR 74082, December 29. 2021 (FRL-
9283-01-OCSPP)) and reopened the comment period for an additional 15
days (87 FR 9047, February 17, 2022 (FRL-9283-02-OCSPP)). EPA
appreciates the public comments received on the draft revision to the
HBCD risk determination. After review of these comments and
consideration of the specific circumstances of 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. Accordingly, EPA is revising and replacing 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. EPA is also withdrawing
the previously-issued TSCA section 6(i)(l) order for six conditions of
use previously determined not to present unreasonable risk that was
included in section 5.4.1 of the September 2020 HBCD risk evaluation.
This final revision to the HBCD 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.
The six conditions of use identified in the 2020 HBCD risk evaluation
as presenting unreasonable risk still drive the unreasonable risk
determination for HBCD. By removing the assumption that all workers
always and appropriately wear PPE (See Unit II.C.), four of the six
conditions of use driving the unreasonable risk to the environment in
the 2020 HBCD risk evaluation now also drive unreasonable risk based on
health risks to workers, an identified potentially exposed or
susceptible subpopulation (PESS). The four conditions of use affected
by this change are: Manufacturing (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
drive the HBCD whole chemical unreasonable risk determination due to
risks identified for both health and the environment. The full list of
the conditions of use evaluated for the HBCD TSCA risk evaluation is in
Table 1-8 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>.
[[Page 38749]]
II. Background
A. Why is EPA re-issuing the risk determination for the HBCD risk
evaluation conducted under TSCA?
In accordance with Executive Order 13990 (Ref. 1) and other
Administration priorities (Refs. 2, 3, and 4), EPA reviewed the risk
evaluations for the first ten chemical substances, including HBCD, 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>). Following a review of specific
aspects of the September 2020 HBCD risk evaluation and after
considering comments received on a draft revised risk determination for
HBCD, EPA has determined that making 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, is the most appropriate approach to
HBCD under the statute and implementing regulations. Second, EPA's
final risk determination is explicit insofar as 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 as a means of addressing
unreasonable risk will be considered during risk management, as
appropriate.
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.
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.
As explained in the Federal Register document announcing the
availability of the draft revised risk determination for HBCD (86 FR
74082, December 29, 2021 (FRL-9283-01-OCSPP), the proposed Risk
Evaluation Procedural Rule (Ref. 5) 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. 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. Ref. 5 at 7480.
The final Risk Evaluation Procedural Rule stated (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 ``which stated that
EPA will make individual risk determinations for all conditions of use
identified in the scope. (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 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
``[e]xplains 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
[[Page 38750]]
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. EPA believes this is a reasonable approach under
TSCA and the Agency's implementing regulations.
With regard to the specific circumstances of HBCD, EPA has
determined that a whole chemical approach is appropriate for HBCD in
order to protect health and the environment. The whole chemical
approach is appropriate for HBCD because there are benchmark
exceedances for multiple conditions of use (spanning across most
aspects of the chemical lifecycle-from manufacturing (import),
processing, commercial use, and disposal) for both health and the
environment, HBCD is persistent, bioaccumulative and toxic substance,
and the health effects associated with HBCD exposures are irreversible.
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 HBCD, EPA has
concluded 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)
follow the issuance of a draft revision to the TSCA HBCD unreasonable
risk determination (86 FR 74082, December 29, 2021) and the receipt of
public comment. A response to comments document is also being issued
with this final revised unreasonable risk determination for HBCD. The
revisions to the unreasonable risk determination are based on the
existing risk characterization section of the risk evaluation (Section
4 of the risk evaluation) 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 HBCD supersede any conflicting statements in the
prior HBCD risk evaluation and the earlier response to comments
document (Ref. 9). 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 HBCD as a whole chemical. Under the revised approach,
the ``whole chemical'' risk determination for HBCD supersedes the no
unreasonable risk determinations for HBCD 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 September 2020 HBCD risk evaluation.
C. What revision is EPA now making final 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 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.,
Occupational Safety and Health Administration (OSHA) requirements for
protection of workers).
For the September 2020 HBCD risk evaluation, EPA assumed that
workers used PPE for six of the twelve conditions of use:
<bullet> Manufacturing--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
EPA is revising the assumption for HBCD 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. 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. 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.
Consistent with this approach, the September 2020 HBCD 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,
[[Page 38751]]
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 best sector practices that address the unreasonable risk are
required for all potentially exposed and susceptible subpopulations of
workers (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 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 is making a determination of unreasonable risk for
HBCD 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 is finalizing the revision to
the HBCD 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 2020 risk
evaluation for HBCD. 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.
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> Manufacturing--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).
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 TSCA Chemical Data Reporting threshold may have 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
XPS and EPS 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 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 HBCD presents an unreasonable risk to health
and the environment under the conditions of use. EPA's unreasonable
risk determination for HBCD is driven by risks associated with the
following conditions of use, considered singularly or in combination
with other exposures:
<bullet> Manufacturing--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
[[Page 38752]]
scenario for the ``Commercial/Consumer Use: Building/Construction
Materials (Installation)'' condition of use, risks were quantified
separately, and consumer use was not found to drive the HBCD
unreasonable risk.
III. Summary of Public Comments
EPA received a total of 25 public comments on the December 29,
2021, draft revised risk determination for HBCD during the initial and
extended comment period from December 29, 2021 to March 4, 2022.
Commenters included trade organizations, trade unions, industry
stakeholders, environmental groups, a Tribal organization, and non-
governmental and 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. 7).
A. General Comments in Support of and Opposed to the Revised Risk
Determination
Several commenters supported the HBCD revised unreasonable risk
determination because the whole chemical approach better aligns with
the goals of TSCA and the 2016 Lautenberg amendments. In addition,
commenters noted that by removing the assumption that workers always
and appropriately wear PPE, EPA can better protect workers and
potentially exposed and sensitive subpopulations (PESS). Those
commenters who opposed the revised risk determination indicated
concerns with unwarranted impacts relating to expected risk management
regulatory decisions, including on articles and associated supply
chains.
EPA Response: EPA appreciates the support for the revised
unreasonable risk determination. With respect to impacts relating to
expected risk management regulation of HBCD, EPA will propose a
regulatory action with requirements under TSCA section 6(a) to the
extent necessary so that HBCD no longer presents unreasonable risk. The
proposed risk management rule will be subject to public comments, and
EPA will consider such public comments and any additional reasonably
available information before finalizing the rulemaking, including
information related to potential impacts to supply chains and HBCD-
containing articles.
B. General Legal Issues
A commentor indicated that EPA should use its authority under TSCA
to research and collect additional occupational exposure data, while
other commentors indicated that the revised unreasonable risk
determination does not comply with TSCA section 26 scientific
requirements and should be updated to reflect EPA's 2021 Draft
Systematic Review protocol.
The second major topic of legal concern raised was whether EPA can
revise the HBCD risk determination prior to undertaking a notice and
comment rulemaking to revise the final Risk Evaluation Rule (Procedures
for Chemical Risk Evaluation Under the Amended Toxic Substances Control
Act (82 FR 33726, July 20, 2017). In the view of commenters, the final
Risk Evaluation Rule, allows EPA to assess risk and promulgate rules
that would apply only to the conditions of use that present
unreasonable risk. Several commenters took issue with EPA's new
interpretation of the final Risk Evaluation Rule, stating that the rule
lacks the ambiguity necessary to permit a court to grant Auer deference
to the EPA's regulatory interpretation. In other words, the commenters
claim the final Risk Evaluation Rule unequivocally requires EPA to make
determinations for each condition of use and those conditions of use
which do not present unreasonable risk would not be subject to risk
management. Commenters indicated that EPA should not be permitted Auer
deference with respect to its regulatory interpretation but rather must
engage in a separate rulemaking with notice and comment to revise that
regulation before engaging in the whole chemical approach to risk
determination.
A third point raised was by a commenter that indicated that EPA did
not fix existing legal flaws in the final risk evaluation, since EPA
did not evaluate risk to all relevant subpopulations, including Alaska
Indigenous Peoples, firefighters, and infants.
EPA Response: EPA identified and reviewed occupational exposure
information through the systematic review process and from public
commenters to inform the HBCD risk evaluation. EPA considers that
information relied on in the risk evaluation, as reflected in the
hazard and exposure assessments and risk characterization in the
September 2020 risk evaluation, to be sufficient on occupational
exposure to make the unreasonable risk determination and inform risk
management. While EPA is undertaking efforts to refine its 2018
approach to systematic review, the draft protocol is not yet final. EPA
expects to apply that protocol, when final, prospectively and not
retroactively; retroactive application would lead to further delays in
completing the risk evaluations for the first ten substances and
associated risk management activities, contrary to Congressional
intent. Thus, EPA maintains that the 2020 HBCD risk evaluation meets
TSCA section 26(h) requirements. EPA welcomes any additional
information from stakeholders during the development of the HBCD risk
management rule; however, EPA expects to be able to complete a proposed
and final risk management rule without additional information regarding
occupational exposures to HBCD.
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). As
to the final Risk Evaluation Rule, EPA acknowledges a lack of
specificity in the statute and inconsistency in the regulations with
respect to the presentation of risk determinations in TSCA section 6
risk evaluations. 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, and the Agency's interpretation is entitled to Auer
deference when using the multifactor test set forth in Kisor (See Ref.
7). As such, notice and comment rulemaking is not necessary before
revising the HBCD risk determination.
As a general matter, EPA must apply one or more requirements in
TSCA section 6(a) to the extent necessary to address the unreasonable
risk determined to be presented through a TSCA section 6(b) risk
evaluation. 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 options related to manufacture,
processing, distribution in commerce, commercial use, and disposal in
order to address the unreasonable risk. For instance, EPA may regulate
upstream activities (e.g., processing, distribution in commerce) in
order to address downstream activities driving unreasonable risk (e.g.,
consumer use) even if the upstream activities do not themselves drive
the unreasonable risk.
As explained in Ref. 9, EPA incorporated aggregate exposures
covering all potential exposure routes
[[Page 38753]]
for the general population and consumers in the final risk evaluation
and the revised unreasonable risk determination. In addition, infants
and subsistence fishers are identified as potentially exposed or
susceptible subpopulations (PESS) and risks are reflected in the final
risk evaluation. Finally, EPA explained how exposures to firefighters
were considered and acknowledges that firefighter exposure to HBCD is
an uncertainty in the risk evaluation (see Section 2.4.1.15.5 of the
Risk Evaluation).
C. Revisions to the Risk Determination--Whole Chemical Approach vs.
Individual Conditions of Use
As mentioned previously, several commenters supported the whole
chemical approach on the basis that TSCA requires EPA to identify the
full risk posed by a chemical substance. One commenter believes TSCA
requires whole chemical determinations of unreasonable risk to satisfy
the mandate to integrate and assess available information on hazards
and exposures from the condition of use, especially in cases of
potentially exposed or susceptible subpopulations, multiple routes of
exposure, and combined risk to exposed populations across the
chemical's conditions of use and life-cycle stages. Others questioned
whether EPA had the authority to change the risk determination to a
whole chemical approach and whether this change was appropriate for
HBCD. Some commenters opposed the whole chemical approach because the
scope of the risk evaluation was based on conditions of use. In
addition, some commenters indicated that EPA does not provide support
for a whole chemical unreasonable risk determination given that certain
conditions of use pose no unreasonable risk and a whole chemical
approach would lump together uses that do not present unreasonable risk
with those that do. Furthermore, the commenter noted that EPA has not
explained why a majority of conditions of use should trigger a whole
chemical unreasonable risk determination, EPA has not provided criteria
for when to take a whole chemical approach, and manufacturers will no
longer have incentives to request risk evaluations. In addition, some
commenters requested that EPA review the whole chemical approach in the
context of the risk management rules, how this approach would affect
risk management, the need to clarify the intended practical and legal
implications of this new approach, and how the implementation of the
whole chemical approach is consistent with the best available science
and the weight of the scientific evidence.
EPA Response: The whole chemical approach is appropriate for HBCD
because there are benchmark exceedances for multiple conditions of use
(spanning across most aspects of the chemical lifecycle-from
manufacturing (import), processing, commercial use, and disposal) for
both health and the environment, HBCD is a persistent, bioaccumulative
and toxic substance, and the health effects associated with HBCD
exposures are irreversible. 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 that the whole chemical presents an unreasonable risk.
The revised unreasonable risk determination for HBCD reflects EPA's
objective of conducting a technically sound, manageable evaluation to
determine whether the chemical substance--not just individual uses or
activities--presents an unreasonable risk.
Responding to comments about conditions of use which previously
were found to not present unreasonable risk for HBCD, in the final
revised risk determination, EPA identifies the conditions of use that
drive the unreasonable risk of HBCD. Consistent with the statutory
requirements of TSCA section 6(a), EPA will propose risk management
regulatory actions to the extent necessary so that HBCD no longer
presents an unreasonable risk. Therefore, it is expected that EPA's
risk management action likely will focus 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. For example, EPA may regulate upstream
activities (e.g., processing, distribution in commerce) in order to
address downstream activities driving unreasonable risk (e.g., consumer
use) even if the upstream activities are do not drive the unreasonable
risk. The public will have an opportunity to provide comments and any
additional information during the comment period for the proposed risk
management rule. In the case of manufacturer-request risk evaluation
(MRRE), EPA has the ability to add conditions of use to the MRRE and it
is possible that only some conditions of use will drive the
unreasonable risk. EPA is mindful of this reality and intends to
continue to be transparent during the risk evaluation and when making
an unreasonable risk determination for the chemical substance as a
whole to articulate which conditions of use drive the unreasonable risk
and which do not. Also, EPA will continue to carry out analysis of the
conditions of use within the scope of the risk evaluation and conduct
risk management rulemaking to address any identified unreasonable risk.
EPA considers the risk characterization, including hazard and
exposure to HBCD, included in the September 2020 risk evaluation to
account for reasonably available information for HBCD, and does not
intend to amend the underlying scientific analysis 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).
D. Revisions to the Risk Determination--Assumptions of Use of Personal
Protective Equipment (PPE)
Some commenters supported EPA's decision to no longer rely on the
assumption that workers always and properly use PPE when evaluating
exposures in a risk evaluation. In their view, EPA needs to evaluate
industry practices and EPA cannot assume that OSHA regulations will
effectively require that workers always and appropriately use PPE. A
commenter noted that the assumption of the use of PPE is not
sufficiently supported by the practical realities of many workplaces. A
commentor indicated that industry best practices are not relevant in
determining whether regulations are needed to protect workers, and
voluntary efforts can disappear in an instant, in a workplace or across
a whole industry, and that regulation is thus needed to protect
employees. Other commenters expressed opposition to EPA's intention not
to assume PPE is always and properly used when conducting risk
evaluations. For example, several commenters stated that EPA's decision
not to assume the use of PPE is inconsistent with the definition of
conditions of use under TSCA and contravenes TSCA's explicit
requirement under TSCA section 26(k)
[[Page 38754]]
to take into consideration information relating to a chemical substance
or mixture, including hazard and exposure information, under the
conditions of use, that is reasonably available to the Administrator.
Some commentors stated that EPA's proposed approach would artificially
increase the calculated human health risk for particular uses of a
chemical and create a false and misleading perception of worker risk. A
couple of commentors suggested that EPA continue the approach of
presenting both scenarios--HBCD use with and without PPE--to provide
the appropriate bounding scenarios for HBCD risk exposures in the
workplace. Another commentor added that it would also be appropriate
for EPA to review and revise its modeling assumptions to ensure they
reflect the state-of-the-art facilities and current industry practices.
A commenter indicated that the discussion regarding industrial hygiene
was imprecise and it is not clear if EPA intents to make unreasonable
risk determinations from a baseline scenario that does not assume
compliance with OSHA standards or the entire industrial hygiene
hierarchy of controls. Several commentors encouraged EPA to coordinate
and engage with OSHA. Finally, there were several comments regarding
EPA's use of the OSHA particulates not otherwise regulated (PNOR)
permissible exposure limit (PEL) to HBCD as an exposure limit reference
to workers engaged in demolition and disposal of XPS and EPS foam
insulation. A commenter provided specific examples of the controls that
are utilized on jobsites to comply with OSHA requirements and minimize
worker exposure to dust and other particulate matter.
EPA Response: EPA believes it is appropriate to evaluate the levels
of risk present in scenarios considering applicable OSHA requirements
as well as scenarios considering industry or sector best practices for
industrial hygiene because such evaluation can help inform potential
risk management actions (i.e., by informing EPA's assessment of the
feasibility and efficacy of different risk management options).
However, EPA cannot reasonably assume that all facilities will have
adopted these practices. Therefore, EPA is making 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.
This 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 because their employer is out of
compliance with OSHA standards, or because EPA finds unreasonable risk
for purposes of TSCA notwithstanding existing OSHA requirements. In
accordance with TSCA section 26(k), EPA considers reasonably available
information, including information on occupational controls and PPE
usage, when conducting TSCA section 6 risk evaluations and risk
management rules.
Under TSCA section 6(a), EPA must apply one or more risk management
requirements to the extent necessary so that a chemical substance no
longer presents unreasonable risk. Those requirements may include
restrictions on the manufacture, processing, distribution in commerce,
commercial use, or disposal of a chemical substance. Because the
requirements and application of TSCA and OSHA regulatory analyses
differ, it is appropriate that EPA conduct risk evaluations and, where
it finds unreasonable risk to workers, develop risk management
requirements for chemical substances that OSHA also regulates, and it
is expected that EPA's findings and requirements may sometimes diverge
from OSHA's. However, it is also appropriate that EPA consider the
standards that OSHA has already developed, so as to limit the
compliance burden to employers by aligning management approaches
required by the agencies, where alignment will adequately address
unreasonable risk to workers. 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 already be common practice in many or most facilities, including
those mentioned by the commenters regarding controls used in demolition
and disposal of XPS and EPS foam insulation. 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.
The revised unreasonable risk determination for HBCD is based on
the underlying risk assessments and risk characterization, in which EPA
evaluated worker risk with and without PPE, and which were peer-
reviewed by the Science Advisory Committee on Chemicals (SACC). EPA
considers the risk characterization, including hazard and exposure to
HBCD, included in the September 2020 risk evaluation to account for
reasonably available information for HBCD, including reasonably
available information regarding state-of-the-art facilities and current
industry practices. Section 4.5.1 and Table 4-27 of the final risk
evaluation summarizes the peer reviewed risk estimates without PPE and
informed the revised unreasonable risk determination.
As previously addressed by the Agency in Ref. 9, the OSHA PNOR PEL
model was used in the absence of relevant data for the Demolition and
Disposal of XPS and EPS Foam Insulation in Residential, Public, and
Commercial Buildings, and Other Structures.
E. Conditions of Use That Drive the Unreasonable Risk Determination
A commenter expressed concern that in the 2020 Risk Evaluation EPA
concluded that the consumer/commercial use of HBCD in articles does not
pose an unreasonable risk, but by taking a whole chemical approach,
EPA's action may foster public perception that these COUs present an
unreasonable risk. Another commenter said that EPA should use a
Significant New Use Rule (SNUR) to confirm cessation of current use and
prevent new uses of HBCD without review and assent by the EPA. One
commenter said that data on the recycling of old EPS building
insulation indicates that it is not being recycled in a manner that
would result in a finding of unreasonable risk; and another commenter
suggested that EPA isolate materials containing HBCD and direct them to
proper disposal. A commenter further indicated that the finding of
demolition of EPS insulation to present an unreasonable risk is based
on inaccurate assumptions and provided similar information to comments
received during the risk evaluation. Another commenter cautioned
against EPA imposing additional duplicative requirements or regulatory
burdens, such as existing stormwater controls. In a similar vein, a
commenter said that the models used to support the unreasonable risk
determination for demolition of buildings with HBCD era EPS over-
estimated the amount of
[[Page 38755]]
HBCD; conversely, another commenter stated that EPA ignored the risk
caused by the disposal of HBCD, particularly the vast quantities of
insulation sent to landfills and incinerators, which resulted in an
underestimation of the risk HBCD.
EPA Response: Consistent with the statutory requirements of TSCA
section 6(a), EPA will propose risk management requirements to the
extent necessary so that HBCD no longer presents an unreasonable risk.
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 options related to manufacture, processing,
distribution in commerce, commercial use, and disposal in order to
address the unreasonable risk. EPA's authority under TSCA section 6(a)
is not affected by the change to a whole chemical risk determination
for HBCD. Processing: Incorporation into Articles is one of the
conditions of use that drives the HBCD unreasonable risk and will be
subject to risk management action. EPA will undertake a separate public
notice and comment period as part of the TSCA section 6(a) risk
management rulemaking for HBCD, and will consider such public comments
and any additional information before finalizing the rulemaking. EPA
acknowledges the commenter's suggestions related to storm water control
requirements and risk management of HBCD, and encourages the commenter
to submit specific comments along these lines during the future public
comment period for the HBCD risk management rule.
EPA appreciates the suggestion to promulgate a SNUR to confirm
cessation of current uses and prevent new uses of HBCD from commencing
without notification to and review by the Agency; however, given
international commitments and anticipated impacts of TSCA section 6(a)
risk management rulemaking for HBCD, it is unlikely that past practices
or new uses of HBCD would be initiated.
With respect to the specific comments regarding recycling and
disposal, EPA originally presented the underlying scientific analysis
in the draft risk evaluation released in July 2019 (84 FR 31315, July
1, 2019 (FRL-9995-40)). The comment period lasted 60 days from July 1,
2019. Based on public comments and peer review comments received, EPA
revised and issued the risk evaluation in September 2020 (85 FR 60456,
September 25, 2020 (FRL-10014-87)). Since changing the risk
determination to a whole chemical approach does not impact the
underlying data and analysis presented in the risk characterization of
the risk evaluation, information provided by the commentors that was
not provided during the draft risk evaluation and not considered in the
risk characterization, will be considered during risk management.
F. Other Comments
Commenters indicated that the risk characterization did not
adequately quantify HBCD's potential harm to children, tribal risk for
Alaska native and arctic indigenous pregnant women and children,
firefighters, disposal, legacy uses, fenceline communities. A commenter
indicated that even a full ban on HBCD cannot be considered to be
protective of risks from legacy use and associated disposal.
Other comments stated that if EPA did not reassess the conditions
of use that do not present unreasonable risk, there is no basis for
withdrawal of the associated orders. Others stated that there would be
regulatory issues regardless because EPA has yet to finalize an amended
risk management rule and resolve potential preemption concerns.
A commenter noted that, due to the highly regulated nature of HBCD
on the international level, the chemical has been phased out of new
production or manufacture of new replacement parts and additional
regulation would be duplicative. One commenter stated that as legacy
replacement parts are phased out of the automobile sector, HBCD will be
cleared from trade channels and pose very little risk to workers and
the general population.
A commenter suggested that EPA conducts another peer-review on the
risk characterization section of the risk determination so that the
lack of PPE use in the future can be thoroughly reviewed and assessed.
Another commenter said that the Federal Register Notice does not
clearly identify the chemicals in HBCD which could cause future
regulatory confusion when applying the whole chemical risk
determination.
EPA Response: As previously explained in Ref. 9, EPA incorporated
aggregate exposures covering all potential exposure routes for the
general population and consumers in the final risk evaluation and now
in the revised unreasonable risk determination. In addition, infants
and subsistence fishers are identified as potentially exposed or
susceptible subpopulations (PESS) and risks are reflected in the final
risk evaluation. Finally, EPA explained how exposures to firefighters
were considered and acknowledges that firefighter exposure to HBCD is
an uncertainty in the risk evaluation (see Section 2.4.1.15.5 of the
Risk Evaluation). Fenceline communities living near disposal sites were
included in the final risk evaluation as part of EPA's assessment of
potential exposure routes for the general population. EPA added
conditions of use for the activities it had initially excluded as
legacy uses and associated disposals in the risk evaluation for HBCD.
Exposure to HBCD from use, reuse, recycling, or disposal of
discontinued products and articles is not excluded from the final risk
evaluation.
Because EPA is finding that HBCD, as a whole chemical substance,
presents unreasonable risk under the conditions of use, EPA is also
withdrawing the TSCA section 6(i)(1) no unreasonable risk order issued
in Section 5.4.1 of the 2020 HBCD risk evaluation. TSCA section
18(c)(3) defines the scope of federal preemption with respect to any
final rule EPA issues under TSCA section 6(a). That provision provides
that federal preemption of statutes, criminal penalties, and
administrative actions applies to the hazards, exposures, risks, and
uses or conditions of use of such chemical substances included in any
final action the Administrator takes pursuant to TSCA section 6(a)] EPA
reads this to mean that states are preempted from imposing requirements
through statutes, criminal penalties, and administrative actions
relating to any hazards, exposures, risks, and uses or conditions of
use evaluated in the final risk evaluation and informing the
unreasonable risk determination that EPA addresses in the TSCA section
6(a) rulemaking. For example, federal preemption applies even if EPA
does not regulate in that final rule a particular COU, but that COU was
evaluated in the final risk evaluation.
There is no change in the underlying scientific analysis of the
September 2020 risk evaluation with regard to COUs that may relate to
replacement parts. The revised risk determination identifies COUs that
drive unreasonable risk from HBCD, which may include COUs that relate
to replacement parts or articles. Under TSCA section 6(c)(2)(D), the
consideration of replacement parts will take place during the risk
management rulemaking stage, based on the risk evaluation findings. EPA
acknowledges the comment about duplicative regulation of HBCD, and
encourages the commenter to submit specific comments along these lines
during the future public comment period for the HBCD risk management
rule.
[[Page 38756]]
The revised unreasonable risk determination for HBCD is based on
the underlying risk assessments and risk characterization, in which EPA
evaluated worker risk with and without PPE, and which were peer-
reviewed by the SACC. No changes have been made to the peer reviewed
risk assessments or risk characterization as a result of revisions to
the risk determination for HBCD, and therefore EPA does not plan to
conduct another round of peer review.
The Executive Summary in the final risk evaluation states that HBCD
is often characterized as a mixture of mainly three diastereomers,
which differ only in the spatial disposition of the atoms:
Hexabromocyclododecane (CASRN 25637-99-4), 1,2,5,6,9,10-
hexabromocyclododecane (CASRN 3194-55-6); and, 1,2,5,6-
tetrabromocyclooctane (CASRN 3194-57-8). The revised unreasonable risk
determination for HBCD applies to the cyclic aliphatic bromide cluster
(HBCD) that includes all three chemicals. Any future proposed and final
rule to address the unreasonable risk presented by HBCD will be for the
HBCD cluster: Hexabromocyclododecane (CASRN 25637-99-4), 1,2,5,6,9,10-
hexabromocyclododecane (CASRN 3194-55-6); and, 1,2,5,6-
tetrabromocyclooctane (CASRN 3194-57-8).
IV. Revision of the September 2020 Risk Evaluation
A. Why is EPA proposing to revise the risk determination for the HBCD
risk evaluation?
EPA is finalizing the revised 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 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 HBCD risk evaluation, this includes: (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 revisions?
EPA is now finalizing the revised risk determination for the HBCD
Risk Evaluation pursuant to TSCA section 6(b). Under the revised
determination, EPA concludes that HBCD, as evaluated in the risk
evaluation as a whole, presents an unreasonable risk of injury to
health and environment under its conditions of use. This revision
replaces the previous unreasonable risk determinations made for HBCD 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. 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 from the HBCD
risk evaluation and the response to comments document (Ref. 9).
In response to public comments, EPA is changing the name of the
condition of use previously named Import to now be named
Manufacturing--Import to clarify that manufacture also includes import,
as defined by TSCA section 3(9). The revised unreasonable risk
determination for HBCD also 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 2020 HBCD risk evaluation.
C. Will the revised risk determination be peer reviewed?
The risk determination (Section 5 of the Risk Evaluation) was not
part of the scope of the Science Advisory Committee on Chemicals (SACC)
peer review of the HBCD risk evaluation. Thus, consistent with that
approach, EPA did not conduct peer review of the final revised
unreasonable risk determination for the HBCD 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 2020
HBCD risk evaluation. This final revised risk determination supersedes
the condition of use-specific no unreasonable risk determinations in
the September 2020 HBCD risk evaluation. The order contained in section
5.5 of the revised risk determination (Ref. 8) withdraws the TSCA
section 6(i)(1) order contained in section 5.4.1 of the September 2020
risk evaluation for HBCD. Consistent with the statutory requirements of
section 6(a), the Agency will propose risk management actions to
address the unreasonable risk determined in the HBCD 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. 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).
2. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register (86 FR 7009, January 25, 2021).
3. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. 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).
7. EPA. Response to Public Comments to the revised Unreasonable Risk
Determination for Cyclic Aliphatic Bromide Cluster (HBCD). June
2022.
8. EPA. Unreasonable Risk Determination for Cyclic Aliphatic Bromide
Cluster (HBCD). June 2022.
9. EPA. Summary of External Peer Review and Public Comments and
Disposition for Cyclic Aliphatic Bromide Cluster (HBCD), September
2020. Available at: <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0237-0069">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0237-0069</a>.
Authority: 15 U.S.C. 2601 et seq.
[[Page 38757]]
Dated: June 23, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-13805 Filed 6-28-22; 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 June 29, 2022.
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.