[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74082-74088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28231]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0237; FRL-9283-01-OCSPP]


Cyclic Aliphatic Bromide Cluster (HBCD); Draft Revision to Toxic 
Substances Control Act (TSCA) Risk Determination; Notice of 
Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and requesting public comment on a draft revision to 
the risk determination for the Cyclic Aliphatic Bromide Cluster (HBCD) 
risk evaluation issued under TSCA. The draft revision to the HBCD risk 
determination was developed following a review of the first ten risk 
evaluations issued under TSCA that was done in accordance with 
Executive Orders and other Administration priorities, including those 
on environmental justice, scientific integrity, and regulatory review, 
and this draft revision reflects the announced policy changes to ensure 
the public is protected from unreasonable risks from chemicals in a way 
that is supported by science and the law. Specifically, in this draft 
revision to the risk determination EPA finds that HBCD, as a whole 
chemical substance, presents an unreasonable risk of injury to health 
and the environment when evaluated under its conditions of use. This 
draft revision supersedes the condition of use-specific no unreasonable 
risk determinations in the September 2020 HBCD risk evaluation (and 
withdraw the associated order) and makes a revised determination of 
unreasonable risk for HBCD as a whole chemical substance. In addition, 
this draft revised risk determination does not reflect an assumption 
that workers always appropriately wear personal protective equipment 
(PPE).

DATES: Comments must be received on or before February 14, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0237, using the Federal eRulemaking Portal 
at https://www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Sarah Cox, Office of Pollution Prevention and Toxics (7404T), 
Environmental

[[Page 74083]]

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-3961; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those involved in the manufacture, 
processing, distribution, use, disposal, and/or the assessment of risks 
involving chemical substances and mixtures. You may be potentially 
affected by this action if you manufacture (defined under TSCA to 
include import), process (including recycling), distribute in commerce, 
use or dispose of HBCD, including HBCD in products. Since other 
entities may also be interested in this draft revision to the risk 
determination, the EPA has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant to the risk evaluation by the Administrator, 
under the conditions of use. 15 U.S.C. 2605(b)(4)(A). TSCA sections 
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements 
applicable to this process, including provisions that provide 
instruction on chemical substances that must undergo evaluation, the 
minimum components of a TSCA risk evaluation, and the timelines for 
public comment and completion of the risk evaluation. TSCA also 
requires that EPA operate in a manner that is consistent with the best 
available science, make decisions based on the weight of the scientific 
evidence and consider reasonably available information. 15 U.S.C. 
2625(h), (i), and (k).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) Integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other non-risk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    EPA has inherent authority to reconsider previous decisions and to 
revise, replace, or repeal a decision to the to the extent permitted by 
law and supported by reasoned explanation. FCC v. Fox Television 
Stations, Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. 
Ass'n v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). 
Further, on August 10, 2021, the Ninth Circuit granted EPA's motion for 
voluntary remand without vacatur, so that EPA may conduct 
reconsideration proceedings on the HBCD Risk Evaluation-particularly to 
reconsider the no unreasonable risk determinations made within. Alaska 
Community Action on Toxics at al., v. U.S. Environmental Protection 
Agency et al., (9th Cir. No. 20-73099).

C. What action is EPA taking?

    EPA is announcing the availability of and seeking public comment on 
a draft revision to the risk determination for the risk evaluation for 
HBCD under TSCA, published in September 2020. EPA is specifically 
seeking public comment on the draft revision to the risk determination 
for the risk evaluation where the Agency intends to determine if HBCD, 
as a whole chemical substance, presents an unreasonable risk of injury 
to health and the environment when evaluated under its conditions of 
use. This whole chemical approach to determining unreasonable risk to 
health is permissible under EPA's statutory obligations under TSCA 
section 6(b)(4) and the implementing regulations and would revise and 
replace section 5 of the 2020 risk evaluation for HBCD where the 
findings of unreasonable risk to health and the environment were 
previously made for the individual conditions of use evaluated.
    This revision would be consistent with EPA's plans to revise 
specific aspects of the first ten TSCA chemical risk evaluations in 
order to ensure that the risk evaluations better align with TSCA's 
objective of protecting health and the environment. Under the proposed 
changes, the same six conditions of use would continue to drive the 
unreasonable risk determination for HBCD. However, the impact of 
removing the assumption of PPE use by workers would cause four of the 
six conditions of use that drive the unreasonable risk determination 
based on only risks to the environment to also drive unreasonable risk 
based on health risks to workers. The four conditions of use affected 
by this proposed change are: Import; Processing: Incorporation into 
formulation, mixture, or reaction products; Processing: Incorporation 
into articles; and Processing: Recycling (of XPS and EPS foam, resin, 
panels containing HBCD). Overall, six conditions of use would drive the 
HBCD whole chemical unreasonable risk determination due to risks 
identified for both the environment and health. The full list of the 
conditions of use evaluated for the HBCD TSCA risk evaluation is in 
Table 8-1 of the risk evaluation available here 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.

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your

[[Page 74084]]

comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. Why is EPA re-issuing the risk determination for the HBCD risk 
evaluation conducted under TSCA?

    In 2016, as directed by TSCA section 6(b)(2)(A), EPA chose the 
first ten chemical substances to undergo risk evaluations under the 
amended TSCA. These chemical substances are asbestos, 1-bromopropane, 
carbon tetrachloride, C.I. Pigment Violet 29, HBCD, 1,4-dioxane, 
methylene chloride, n-methylpyrrolidone (NMP), perchloroethylene (PCE), 
and trichloroethylene (TCE).
    From June 2020 to January 2021, EPA published risk evaluations on 
the first ten chemical substances, including for HBCD in September 
2020. The risk evaluations included individual unreasonable risk 
determinations for each condition of use evaluated. The determinations 
that particular conditions of use did not present an unreasonable risk 
were issued by order under TSCA section 6(i)(1).
    In accordance with Executive Order 13990 (Ref. 2) and other 
Administration priorities (Refs. 1, 3, and 4), EPA reviewed the risk 
evaluations for the first ten chemical substances to ensure that they 
meet the requirements of TSCA, including conducting decision-making in 
a manner that is consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment 
available here https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations. To that end, EPA is 
reconsidering two key aspects of the risk determinations for HBCD 
published in September 2020. First, EPA proposes that the appropriate 
approach to these determinations under the statute and implementing 
regulations is to make an unreasonable risk determination for HBCD as a 
whole chemical substance, rather than making unreasonable risk 
determinations separately on each individual condition of use evaluated 
in the risk evaluation. Second, EPA proposes that the risk 
determination should be explicit that it does not rely on assumptions 
regarding the use of personal protective equipment (PPE) in making the 
unreasonable risk determination under TSCA section 6; rather, the use 
of PPE would be considered during risk management.
    This action pertains only to the risk determination for HBCD. While 
EPA intends to consider and may take additional similar actions on 
other of the first ten chemicals, EPA is taking a chemical-specific 
approach to reviewing these risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of 
Congressional direction on the need to complete risk evaluations and 
move toward any associated risk management activities in accordance 
with statutory deadlines. To the extent the Agency deems appropriate, 
additional actions may follow that are specific to each of the other 
chemical substances for which EPA has issued completed risk evaluations 
under TSCA section 6.

B. What is a whole chemical view of the unreasonable risk determination 
for the HBCD risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations. EPA acknowledges a lack of specificity in the 
statute and inconsistency in the regulations with respect to the 
presentation of risk determinations in TSCA risk evaluations.
    The proposed Risk Evaluation Rule (Ref. 5), was premised on the 
whole chemical approach to making unreasonable risk determinations. EPA 
acknowledged a lack of specificity in whether the statute compelled 
EPA's risk evaluations to address all conditions of use of a chemical 
substance or whether EPA had discretion to evaluate some subset of 
conditions of use (i.e., to scope out some manufacturing, processing, 
distribution in commerce, use, or disposal activities). The proposed 
rule, however, was unambiguous on the point that unreasonable risk 
determinations would be for the chemical substance as a whole, even if 
based on a subset of uses. See Ref. 5 at 7565-66 (TSCA section 
6(b)(4)(A) specifies that a risk evaluation must determine whether `a 
chemical substance' presents an unreasonable risk of injury to health 
or the environment `under the conditions of use.' The evaluation is on 
the chemical substance--not individual conditions of use--and it must 
be based on `the conditions of use.' In this context, EPA believes the 
word `the' is best interpreted as calling for evaluation that considers 
all conditions of use.). In proposed regulatory text, EPA proposed to 
``determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under the conditions of use 
as identified in the final scope document . . .'' Ref. 5 at 7480.
    As stated in the final Risk Evaluation Rule (82 FR 33726, July 20, 
2017) (FRL-9964-38) (Ref. 6): As part of the risk evaluation, EPA will 
determine whether the chemical substance presents an unreasonable risk 
of injury to health or the environment under each condition of uses 
[sic] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents (40 CFR 702.47). 
For the unreasonable risk determinations in the first ten risk 
evaluations, EPA applied this provision by making individual risk 
determinations for each condition of use evaluated as part of each risk 
evaluation document (i.e., the condition-of-use-specific approach to 
risk determinations). That approach was based on one particular passage 
in the preamble to the final Risk Evaluation Rule: The final step of a 
risk evaluation is for EPA to determine whether the chemical substance, 
under the conditions of use, presents an unreasonable risk of injury to 
health or the environment. EPA will make individual risk determinations 
for all uses identified in the scope. This part of the regulation is 
slightly amended from the proposed rule, to clarify that the risk 
determination is part of the risk evaluation, as well as to account for 
the revised approach to that [sic] ensures each condition of use 
covered by the risk evaluation receives a risk determination. (Ref. 6 
at 33744).
    In contrast to this portion of the preamble of the final Risk 
Evaluation Rule, the regulatory text itself and other statements in the 
preamble reference a risk determination for the chemical substance 
under its conditions of use, rather than separate risk determinations 
for each of the conditions of use of a chemical substance. In the key 
regulatory provision excerpted previously from 40 CFR 702.47, the text 
explains that, [a]s part of the risk evaluation, EPA will determine 
whether the chemical substance presents an unreasonable risk of injury 
to health or the environment under each condition of uses [sic] within 
the scope of the risk evaluation, either in a single decision

[[Page 74085]]

document or in multiple decision documents (emphasis added). Other 
language reiterates this perspective. For example, 40 CFR 702.31(a) 
states that the purpose of the rule is to establish the EPA process for 
conducting a risk evaluation to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment as 
required under TSCA section 6(b)(4)(B). Likewise, there are recurring 
references to whether the chemical substance presents an unreasonable 
risk in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which 
states: [t]he extent to which EPA will refine its evaluations for one 
or more condition of use in any risk evaluation will vary as necessary 
to determine whether a chemical substance presents an unreasonable risk 
of injury to health or the environment. Notwithstanding the one 
preambular statement about condition-of-use-specific risk 
determinations, the preamble to the final rule also contains support 
for a risk determination on the chemical substance as a whole. In 
discussing the identification of the conditions of use of a chemical 
substance, the preamble notes that this task inevitably involves the 
exercise of discretion on EPA's part, and, as EPA interprets the 
statute, the Agency is to exercise that discretion consistent with the 
objective of conducting a technically sound, manageable evaluation to 
determine whether a chemical substance--not just individual uses or 
activities--presents an unreasonable risk. (Ref. 6 at 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue whole-chemical 
risk determinations. Either approach is permissible under the 
regulation. A panel of the Ninth Circuit Court of Appeals also 
recognized the ambiguity of the regulation on this point. Safer 
Chemicals v. EPA, 943 F.3d 397, 413 (9th Cir. 2019) (holding a 
challenge about ``use-by-use risk evaluations [was] not justiciable 
because it is not clear, due to the ambiguous text of the Risk 
Evaluation Rule, whether the Agency will actually conduct risk 
evaluations in the manner Petitioners fear''). EPA plans to consider 
the appropriate approach for each chemical substance risk evaluation on 
a case-by-case basis, taking into account considerations relevant to 
the specific chemical substance in light of the Agency's obligations 
under TSCA. The Agency expects that this case-by-case approach will 
provide greater flexibility in the Agency's ability to evaluate and 
manage unreasonable risk from individual chemical substances. For 
instance, circumstances in which an unreasonable risk determination is 
primarily driven by a single condition of use that does not impact or 
intersect with other evaluated uses (such as for example, a single 
consumer use of a substance out of a wide range of other manufacturing, 
processing and consumer uses evaluated) may warrant different treatment 
than circumstances in which the majority of the chemical substance's 
conditions of use contribute to unreasonable risk, and the Agency might 
adopt different approaches to the risk determinations in those 
particular instances. EPA anticipates that this flexibility will better 
serve TSCA's objectives by helping ensure that EPA is best positioned 
to present, and initiate risk management to address, chemical-specific 
unreasonable risk determinations. EPA believes this is a reasonable 
approach under TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of HBCD, as further 
explained in this document, EPA proposes that a whole chemical approach 
better aligns with TSCA's objective of protecting health and the 
environment. For HBCD, EPA favors the whole chemical approach based in 
part on the benchmark exceedances for multiple conditions of use 
(spanning across most aspects of the chemical lifecycle--from 
manufacturing (import), processing, commercial and consumer use, and 
disposal) for both health and the environment and considering the 
physical-chemical properties of HBCD as a persistent, bioaccumulative 
and toxic substance, and the irreversible health effects associated 
with HBCD exposures. Since the chemical-specific properties cut across 
the conditions of use within the scope of the risk evaluation, the 
Agency's risk findings and conclusions encompass the majority of those 
conditions of use, and the Agency is better positioned to achieve its 
TSCA objectives for HBCD when issuing a whole chemical determination 
for HBCD, EPA concludes that the Agency's risk determination for HBCD 
is better characterized as a whole chemical risk determination rather 
than condition-of-use-specific risk determinations.
    As explained later in this document, the revisions to the 
unreasonable risk determination (section 5 of the risk evaluation) 
would be based on the existing risk characterization section of the 
risk evaluation (section 4 of the risk evaluation) and would not 
involve additional technical or scientific analysis. The discussion of 
the issues in this Federal Register Notice and in the accompanying 
draft revision to the risk determination would supersede any 
conflicting statements in the prior HBCD risk evaluation and the 
response to comments document (Summary of External Peer Review and 
Public Comments and Disposition for HBCD). With respect to the HBCD 
risk evaluation, EPA intends to change the risk determination to a 
whole chemical approach and does not intend to amend, nor does a whole 
chemical approach require amending, the underlying scientific analysis 
of the risk evaluation in the risk characterization section of the risk 
evaluation. EPA also views the peer reviewed hazard and exposure 
assessments and associated risk characterization as robust and 
upholding the standards of best available science and weight of the 
scientific evidence per TSCA sections 26(h) and (i).
    EPA is announcing the availability of and soliciting public comment 
on the draft superseding unreasonable risk determination for HBCD, 
including a list of the condition-of-use-specific risks driving the 
unreasonable risk determination for the chemical substance as a whole. 
For purposes of TSCA section 6(i), EPA is making a risk determination 
on HBCD as a whole chemical. Under the revised approach, EPA is 
proposing to supersede the no unreasonable risk determinations (and 
withdraw the associated order) for HBCD that were premised on a 
condition-of-use-specific approach to determining unreasonable risk.

C. What revision does EPA propose about the use of PPE for the HBCD 
risk evaluation?

    In the risk evaluations for the first ten chemical substances, as 
part of the unreasonable risk determination, EPA assumed for several 
conditions of use that all workers were provided and always used PPE in 
a manner that achieves the stated assigned protection factor (APF) for 
respiratory protection, or protection factor (PF) for dermal 
protection. In support of this assumption, EPA used reasonably 
available information such as public comments indicating that some 
employers, particularly in the industrial setting, provide PPE to their 
employees and follow established worker protection standards (e.g., 
Occupational Safety and Health Administration (OSHA) requirements for 
protection of workers).
    For the September 2020 HBCD risk evaluation, EPA assumed that 
workers

[[Page 74086]]

used PPE for six of the twelve conditions of use:
     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
    When characterizing the risk to human health from occupational 
exposures during risk evaluation under TSCA, EPA believes it is 
appropriate to evaluate the levels of risk present in baseline 
scenarios where no mitigation measures are assumed to be in place. This 
approach considers the risk to potentially exposed or susceptible 
subpopulations of workers who may not be covered by OSHA standards, 
such as self-employed individuals and public sector workers who are not 
covered by a State Plan. In addition, EPA believes it is appropriate to 
evaluate the levels of risk present in scenarios considering applicable 
OSHA requirements (e.g., chemical-specific permissible exposure limits 
(PELs) and/or chemical-specific PELs with additional substance-specific 
standards) as well as scenarios considering industry or sector best 
practices for industrial hygiene that are clearly articulated to the 
Agency. It should be noted that, in some cases, baseline conditions may 
reflect certain mitigation measures, such as engineering controls, in 
instances where exposure estimates are based on monitoring data at 
facilities that have engineering controls in place. Consistent with 
this approach, the September 2020 HBCD risk evaluation characterized 
risk to workers both with and without the use of PPE.
    When undertaking unreasonable risk determinations as part of TSCA 
risk evaluations, however, EPA does not believe it is appropriate to 
assume as a general matter that an applicable OSHA requirement or 
industry practice is sufficient to address the risk, applicable to all 
potentially exposed workers, or consistently and always properly 
applied. Mitigation scenarios included in the EPA risk evaluation 
(e.g., scenarios considering use of various PPE) likely represent what 
is happening already in some facilities. However, the Agency cannot 
assume that all facilities have adopted these practices for the 
purposes of making the TSCA risk determination. Additionally, as 
previously noted, self-employed individuals and public sector workers 
who are not covered by a State Plan are not covered by OSHA 
requirements. By characterizing risks using scenarios that reflect 
different levels of mitigation, EPA risk evaluations can help inform 
potential risk management actions by providing information that could 
be used during risk management to tailor risk mitigation appropriately 
to address any unreasonable risk identified.
    Therefore, going forward, EPA intends to make its determination of 
unreasonable risk from a baseline scenario that does not assume 
compliance with OSHA standards, including any applicable exposure 
limits or requirements for use of respiratory protection or other PPE. 
Making unreasonable risk determinations based on the baseline scenario 
should not be viewed as an indication that EPA believes there are no 
occupational safety protections in place at any location, or that there 
is widespread non-compliance with applicable OSHA standards. Rather, it 
reflects EPA's recognition that unreasonable risk may exist for 
subpopulations of workers that may be highly exposed because they are 
not covered by OSHA standards, such as self-employed individuals and 
public sector workers who are not covered by a State Plan, or because 
their employer is out of compliance with OSHA standards, or because EPA 
finds unreasonable risk for purposes of TSCA notwithstanding OSHA 
requirements.
    In accordance with this approach, EPA proposes that the draft 
revision to the HBCD risk determination not rely on assumptions 
regarding the occupational use of PPE in making the unreasonable risk 
determination under TSCA section 6; rather, the use of PPE would be 
considered during risk management. This would represent a change from 
the approach taken in the 2020 risk evaluation for HBCD and EPA invites 
comments on this proposed change to the HBCD risk determination. As a 
general matter, when undertaking risk management actions, EPA intends 
to strive for consistency with applicable OSHA requirements and 
industry best practices, including appropriate application of the 
hierarchy of controls, when those measures would address an 
unreasonable risk; ensure the EPA requirements apply to all potentially 
exposed workers; and develop occupational risk mitigation measures to 
address any unreasonable risks identified by EPA. Consistent with TSCA 
section 9(d), EPA will consult and coordinate TSCA activities with OSHA 
and other relevant Federal agencies for the purpose of achieving the 
maximum applicability of TSCA while avoiding the imposition of 
duplicative requirements. Informed by the mitigation scenarios and 
information gathered during the risk evaluation and risk management 
process, the Agency might propose rules that require risk management 
practices that may be already common practice in many or most 
facilities. Adopting clear, comprehensive regulatory standards will 
foster compliance across all facilities (ensuring a level playing 
field) and assure protections for all affected workers, especially in 
cases where current OSHA standards may not apply or be sufficient to 
address the unreasonable risk.
    By removing the assumption of PPE use in making the whole chemical 
risk determination for HBCD the same six conditions of use would 
continue to drive the proposed unreasonable risk determination. 
However, the impact of removing the assumption of PPE use would cause 
four of the six conditions of use that drive the unreasonable risk 
determination based on only risks to the environment to also drive 
unreasonable risk based on health risks to workers. The four conditions 
of use affected by this change are:
     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).
    The draft revision to the risk determination would clarify that EPA 
does not rely on the assumed use of PPE when making the risk 
determination for the whole substance. EPA is requesting comment on 
this potential change.

D. What is HBCD?

    HBCD is a white odorless non-volatile solid that is used as a flame 
retardant and wetting agent. Domestic manufacture of HBCD ceased in 
2017 and was therefore not considered as a condition of use for the 
risk evaluation. U.S. manufacturers have indicated complete replacement 
of HBCD in their product lines and that depletion of stockpiles and 
cessation of export was completed in 2017 based on communications with 
manufacturers. HBCD has also not been imported by any major importers 
since 2017; however, it is reasonably foreseen that small imports under 
the Chemical Data Reporting threshold may have

[[Page 74087]]

continued from countries that were not parties to the Stockholm 
Convention ban. About 95% of HBCD was historically used in insulation 
boards, primarily in construction materials, which may include 
structural insulated panels (SIPS). The category ``Building/
Construction Materials'' includes products containing HBCD as a flame 
retardant primarily in XPS and EPS rigid foam insulation products that 
are used for the construction of residential, public, commercial, or 
other structures. HBCD is added to EPS and XPS foam in the form of a 
resin. EPS foam prevents freezing, provides a stable fill material, and 
creates high-strength composites in construction applications. XPS foam 
board is used mainly for roofing applications and architectural 
molding. Minor uses of HBCD include replacement car parts (polystyrene 
headliners and solder) and solder paste for electronics (circuit 
boards). Historically, HBCD was also manufactured (including import) 
and processed for additional articles that may still exist, including 
adhesives, coatings, sealants, textiles, and electronics.

E. What conclusions did EPA reach about the risks of HBCD in the TSCA 
risk evaluation based on the whole chemical approach and not assuming 
the use of PPE?

    EPA determined that HBCD presents an unreasonable risk to health 
and the environment and the unreasonable risk is driven by risks 
associated with the following conditions of use, considered singularly 
or in combination with other exposures:
     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 scenario, risks were quantified separately, and consumer 
use was not found to contribute to unreasonable risk (Executive Summary 
of the Risk Evaluation).

III. Revision of the September 2020 Risk Evaluation

A. Why is EPA proposing to revise the risk determination for the HBCD 
risk evaluation?

    EPA is proposing to revise the risk determination for the HBCD risk 
evaluation pursuant to TSCA section 6(b) and consistent with Executive 
Order 13990, (Ref 2) and other Administration priorities (Refs. 1, 3, 
and 4). EPA plans to consider revising specific aspects of the first 
ten TSCA existing chemical risk evaluations in order to ensure that the 
risk evaluations better align with TSCA's objective of protecting 
health and the environment. For the HBCD risk evaluation, this includes 
the proposed revisions: (1) Making the risk determination in this 
instance based on the whole chemical approach instead of by individual 
conditions of use and (2) emphasizing that EPA does not rely on the 
assumed use of PPE when making the risk determination.

B. What are the draft revisions?

    EPA is releasing a draft revision of the risk determination for the 
HBCD Risk Evaluation pursuant to TSCA section 6(b). Under the revised 
determination, EPA proposes to conclude that HBCD, as evaluated in the 
risk evaluation as a whole, presents an unreasonable risk of injury to 
health and environment when evaluated under its conditions of use. This 
revision would replace the previous unreasonable risk determinations 
made for HBCD by individual conditions of use, supersede the 
determinations (and withdraw the associated order) of no unreasonable 
risk for the conditions of use identified in the no unreasonable risk 
order, and clarify the lack of reliance on assumed use of PPE as part 
of the risk determination.
    These draft revisions do not alter any of the underlying technical 
or scientific information that informs the risk characterization, and 
as such the hazard, exposure, and risk characterization sections are 
not changed. The discussion of the issues in this Notice and in the 
accompanying draft revision to the risk determination would supersede 
any conflicting statements in the prior executive summary from the HBCD 
risk evaluation and the response to comments document (Summary of 
External Peer Review and Public Comments and Disposition for HBCD). 
Additional policy changes to other chemical risk evaluations, including 
any proposed consideration of potentially exposed and susceptible 
subpopulations and/or inclusion of additional exposure pathways, are 
not necessarily reflected in these draft revisions to the risk 
determination.

C. Will the draft revised risk determination be peer reviewed?

    The risk determination (Section 5 of this Risk Evaluation) was not 
part of the scope of the Science Advisory Committee on Chemicals (SACC) 
peer reviews of the first ten priority chemicals. Thus, consistent with 
that approach, EPA does not intend to conduct peer review for the draft 
revised unreasonable risk determination for the HBCD risk evaluation 
because no technical or scientific changes will be made to the hazard 
or exposure assessments or the risk characterization.

D. What are the next steps for finalizing revisions to the risk 
determination?

    EPA will review and consider public comment received on the draft 
revised risk determination for the HBCD risk evaluation and, after 
considering those public comments, issue the revised final HBCD risk 
determination. If finalized as proposed, EPA would also issue a new 
order to withdraw the TSCA Section 6(i)(1) no unreasonable risk order 
issued in Section 5.4.1 of the 2020 HBCD risk evaluation. This final 
revised risk determination would supersede the September 2020 risk 
determinations of no unreasonable risk. Consistent with the statutory 
requirements of section 6(a), the Agency would then propose risk 
management actions to address the unreasonable risk determined in the 
HBCD risk evaluation.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.
    1. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register (86 FR 7009, January 25, 2021).
    2. Executive Order 13990. Protecting Public Health and the 
Environment and Restoring Science to Tackle the Climate Crisis. Federal 
Register (86 FR 7037, January 25, 2021).
    3. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad.

[[Page 74088]]

Federal Register (86 FR 7619, February 1, 2021).
    4. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register (86 FR 8845, February 10, 2021).
    5. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation 
Under the Amended Toxic Substances Control Act. Federal Register (82 FR 
7562, January 19, 2017) (FRL-9957-75).
    6. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register (82 FR 
33726, July 20, 2017) (FRL-9964-38).
    Authority: 15 U.S.C. 2601 et seq.

Michael S. Regan,
Administrator.
[FR Doc. 2021-28231 Filed 12-28-21; 8:45 am]
BILLING CODE 6560-50-P