Document ID: EPA-HQ-OPPT-2019-0237-0122
Agency: epa
Document Type: Notice
Title: Cyclic Aliphatic Bromide Cluster (HBCD); Revision to the Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability
Posted Date: 2022-06-29T04:00Z

[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38747-38757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13805]

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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.

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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 https://www.regulations.gov 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 https://www.epa.gov/dockets.

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general 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 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.

[[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 https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations). 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:
     Manufacturing--Import;
     Processing: Incorporating into formulation, mixture, or 
reaction products;
     Processing: Incorporation into article;
     Processing: Recycling (of XPS and EPS foam, resin, panels 
containing HBCD);
     Processing: Recycling (of electronics waste containing 
high impact polystyrene (HIPS) that contains HBCD); and
     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:
     Manufacturing--Import;
     Processing: Incorporation into formulation, mixture, or 
reaction products;
     Processing: Incorporation into article; and
     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:
     Manufacturing--Import;
     Processing: Incorporation into a Formulation, Mixture, or 
Reaction Products;
     Processing: Incorporation into Article;
     Processing: Recycling (of XPS and EPS foam, resin, and 
panels containing HBCD);
     Commercial/Consumer Use: Building/Construction Materials 
(Installation); and
     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: https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0237-0069.

    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