Cyclic Aliphatic Bromide Cluster (HBCD); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability, 60456-60458 [2020-21133]
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Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Notices
[FRL–10015–06–OA]
Notice of Meeting of the EPA
Children’s Health Protection Advisory
Committee (CHPAC)
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Pursuant to the provisions of
the Federal Advisory Committee Act,
notice is hereby given that the next
meeting of the Children’s Health
Protection Advisory Committee
(CHPAC) will be held virtually October
22, 2020. The CHPAC advises the
Environmental Protection Agency (EPA)
on science, regulations and other issues
relating to children’s environmental
health.
DATES: October 22, 2020 from 2 p.m. to
5 p.m.
ADDRESSES: The meeting will take place
virtually. If you want to listen to the
meeting or provide comments, please
email louie.nica@epa.gov for further
details.
FOR FURTHER INFORMATION CONTACT: Nica
Louie, Office of Children’s Health
Protection, U.S. EPA, MC 1107T, 1200
Pennsylvania Avenue NW, Washington,
DC 20460, (202) 564–7633 or
louie.nica@epa.gov.
SUPPLEMENTARY INFORMATION: The
meetings of the CHPAC are open to the
public. An agenda will be posted to
https://www.epa.gov/children/
childrens-health-protection-advisorycommittee-chpac.
Access and Accommodations: For
information on access or services for
individuals with disabilities, please
contact Nica Louie at 202–564–7633 or
louie.nica@epa.gov.
SUMMARY:
Dated: September 16, 2019.
Nica Mostaghim,
Environmental Health Scientist.
[FR Doc. 2020–21143 Filed 9–24–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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[EPA–HQ–OPPT–2019–0237; FRL–10014–
87]
Cyclic Aliphatic Bromide Cluster
(HBCD); Final Toxic Substances
Control Act (TSCA) Risk Evaluation;
Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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The Environmental Protection
Agency (EPA) is announcing the
availability of the final Toxic
Substances Control Act (TSCA) risk
evaluation of Cyclic Aliphatic Bromide
Cluster (HBCD). The purpose of
conducting risk evaluations under
TSCA is to determine whether a
chemical substance presents an
unreasonable risk of injury to health or
the environment under the conditions of
use, including an unreasonable risk to a
relevant potentially exposed or
susceptible subpopulation, without
consideration of costs or other nonrisk
factors. EPA has determined that
specific conditions of use of HBCD
present an unreasonable risk of injury to
health or the environment. For those
conditions of use for which EPA has
found an unreasonable risk, EPA must
take regulatory action to address that
unreasonable risk through risk
management measures enumerated in
TSCA. EPA has also determined that
specific conditions of use do not present
unreasonable risk of injury to health or
the environment. For those conditions
of use for which EPA has found no
unreasonable risk to health or the
environment, the Agency’s
determination is a final Agency action
and is issued via order in the 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),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
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 Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Public Reading
Room is closed to visitors with limited
exceptions. The EPA/DC staff continue
to provide remote customer service via
email, phone, and webform. 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: Dr. Stan
Barone, Office of Pollution Prevention
and Toxics (7403M), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
SUMMARY:
ENVIRONMENTAL PROTECTION
AGENCY
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telephone number: (202) 564–1169;
email address: barone.stan@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public
in general. This action may be of
interest to persons who are or may be
interested in risk evaluations of
chemical substances under TSCA, 15
U.S.C. 2601 et seq. Since other entities
may also be interested in this final risk
evaluation, 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 nonrisk 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). TSCA section 6(i) directs that a
determination of ‘‘no unreasonable risk’’
shall be issued by order and considered
to be a final Agency action, while a
determination of ‘‘unreasonable risk’’ is
not considered to be a final Agency
action. 15 U.S.C. 2605(i).
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
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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)–(ii) and (iv)–(v).
Each risk evaluation must not consider
costs or other nonrisk factors. 15 U.S.C.
2605(b)(4)(F)(iii).
The statute requires that the risk
evaluation process be completed within
a specified timeframe and provide an
opportunity for public comment on a
draft risk evaluation prior to publishing
a final risk evaluation. 15 U.S.C.
2605(b)(4).
Subsection 5.4.1 of the final risk
evaluation for HBCD constitutes the
order required under TSCA section
6(i)(1), and the ‘‘no unreasonable risk’’
determinations in that subsection are
considered to be a final Agency action
effective on the date of issuance of the
order. In conducting risk evaluations,
‘‘EPA will determine whether the
chemical substance presents an
unreasonable risk of injury to health or
the environment under each condition
of use within the scope of the risk
evaluation. . .’’ 40 CFR 702.47. Under
EPA’s implementing regulations, ‘‘[a]
determination by EPA that the chemical
substance, under one or more of the
conditions of use within the scope of
the risk evaluation, does not present an
unreasonable risk of injury to health or
the environment will be issued by order
and considered to be a final Agency
action, effective on the date of issuance
of the order.’’ 40 CFR 702.49(d). For
purposes of TSCA section 19(a)(1)(A),
the date of issuance of the section 6(i)(1)
order for HBCD shall be at 1:00 p.m.
Eastern time (standard or daylight, as
appropriate) on the date that is two
weeks after the date when this notice is
published in the Federal Register,
which is in accordance with 40 CFR
23.5.
C. What action is EPA taking?
EPA is announcing the availability of
the risk evaluation of the chemical
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substance identified in Unit II. In this
risk evaluation EPA has made
unreasonable risk determinations on
some of the conditions of use within the
scope of the risk evaluation for this
chemical. For those conditions of use
for which EPA has found an
unreasonable risk of injury to health or
the environment, EPA must take
regulatory action to address those risks
through risk management measures
enumerated in 15 U.S.C. 2605(a).
EPA also is announcing the
availability of the information required
to be provided publicly with each risk
evaluation, which is available online at
https://www.regulations.gov in the
dockets identified. 40 CFR 702.51.
Specifically, EPA has provided:
• The scope document and problem
formulation (in Docket ID No. EPA–HQ–
OPPT–2016–0735);
• Draft risk evaluation, and final risk
evaluation (in Docket ID No. EPA–HQ–
OPPT–2019–0237);
• All notices, determinations,
findings, consent agreements, and
orders (in Docket ID No. EPA–HQ–
OPPT–2019–0237);
• Any information required to be
provided to the Agency under 15 U.S.C.
2603 (in Docket ID No. EPA–HQ–OPPT–
2016–0735 and Docket ID No. EPA–HQ–
OPPT–2019–0237);
• A nontechnical summary of the risk
evaluation (in Docket ID No. EPA–HQ–
OPPT–2019–0237);
• A list of the studies, with the results
of the studies, considered in carrying
out each risk evaluation (Risk
Evaluation for Cyclic Aliphatic Bromide
Cluster (HBCD Cluster) in Docket ID No.
EPA–HQ–OPPT–2019–0237);
• The final peer review report,
including the response to peer review
and public comments received during
peer review (in Docket ID No. EPA–HQ–
OPPT–2019–0237); and
• Response to public comments
received on the draft scope and the draft
risk evaluation (in Docket ID No. EPA–
HQ–OPPT–2019–0237).
II. TSCA Risk Evaluation
A. What is EPA’s risk evaluation process
for existing chemicals under TSCA?
The risk evaluation process is the
second step in EPA’s existing chemical
review process under TSCA, following
prioritization and before risk
management. As this chemical is one of
the first ten chemical substances
undergoing risk evaluation, the
chemical substance was not required to
go through prioritization (81 FR 91927,
December 19, 2016) (FRL–9956–47). The
purpose of conducting risk evaluations
is to determine whether a chemical
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substance presents an unreasonable risk
of injury to health or the environment
under the conditions of use, including
an unreasonable risk to a relevant
potentially exposed or susceptible
subpopulation. As part of this process,
EPA must evaluate both hazard and
exposure, not consider costs or other
nonrisk factors, use reasonably available
information and approaches in a
manner that is consistent with the
requirements in TSCA for the use of the
best available science, and ensure
decisions are based on the weight of
scientific evidence.
The specific risk evaluation process
that EPA has established by rule to
implement the statutory process is set
out in 40 CFR part 702 and summarized
on EPA’s website at https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluationsexisting-chemicals-under-tsca. As
explained in the preamble to EPA’s final
rule on procedures for risk evaluation
(82 FR 33726, July 20, 2017) (FRL–
9964–38), the specific regulatory
process set out in 40 CFR part 702,
subpart B is being followed for the first
ten chemical substances undergoing risk
evaluation to the maximum extent
practicable.
Prior to the publication of this final
risk evaluation, a draft risk evaluation
was subject to peer review and public
comment. EPA reviewed the report from
the peer review committee and public
comments and has amended the risk
evaluation in response to these
comments as appropriate. The public
comments, peer review report, and
EPA’s response to comments is in
Docket ID No. EPA–HQ–OPPT–2019–
0237. Prior to the publication of the
draft risk evaluation, EPA made
available the scope and problem
formulation, and solicited public input
on uses and exposure. EPA’s documents
and the public comments are in Docket
ID No. EPA–HQ–OPPT–2016–0735.
Additionally, information about the
scope, problem formulation, and draft
risk evaluation phases of the TSCA risk
evaluation for this chemical is at https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluationcyclic-aliphatic-bromide-cluster-hbcd.
B. What is Cyclic Aliphatic Bromide
Cluster (HBCD Cluster)?
The cyclic aliphatic bromide cluster
chemicals, including
hexabromocyclododecane (HBCD), are
flame retardants. Other uses include use
as a component of solder and use in
automobile replacement parts. EPA has
not identified reasonably available
information to suggest that HBCD is
currently domestically manufactured in
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Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Notices
EIS No. 20200193, Final, BR, CA,
Truckee Canal Extraordinary
Maintenance, Review Period Ends:
10/26/2020, Contact: Laurie Nicholas
775–884–8360.
EIS No. 20200194, Final, NNSA, SC,
Plutonium Pit Production at the
Savannah River Site in South
Carolina, Review Period Ends: 10/26/
2020, Contact: Ms. Jennifer Nelson
803–557–6372.
any quantity. Companies have the
ability to import the chemical in low
volumes below the CDR reporting
threshold.
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020–21133 Filed 9–24–20; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[ER–FRL–9053–1]
khammond on DSKJM1Z7X2PROD with NOTICES
Environmental Impact Statements;
Notice of Availability
Responsible Agency: Office of Federal
Activities, General Information 202–
564–5632 or https://www.epa.gov/nepa.
Weekly receipt of Environmental Impact
Statements (EIS)
Filed September 14, 2020 10 a.m. EST
Through September 21, 2020 10 a.m.
EST
Pursuant to 40 CFR 1506.9.
Notice: Section 309(a) of the Clean Air
Act requires that EPA make public its
comments on EISs issued by other
Federal agencies. EPA’s comment letters
on EISs are available at: https://
cdxnodengn.epa.gov/cdx-enepa-public/
action/eis/search.
EIS No. 20200188, Draft Supplement,
USFS, WV, Mountain Valley Pipeline
and Equitrans Expansion Project Draft
Supplemental Environmental Impact
Statement, Comment Period Ends: 11/
09/2020, Contact: Ken Arney 888–
603–0261.
EIS No. 20200189, Draft, USAF, GA,
Moody Air Force Base Comprehensive
Airspace Initiative, Comment Period
Ends: 11/24/2020, Contact: Lorence
Busker 229–257–2396.
EIS No. 20200190, Draft, USAF, TX, B–
21 Main Operating Base (MOB 1)
Beddown at Dyess AFB, Texas or
Ellsworth AFB South Dakota,
Comment Period Ends: 11/09/2020,
Contact: Julianne Turko 210–925–
3777.
EIS No. 20200191, Final, USFS, AK,
Rulemaking for Alaska Roadless
Areas, Review Period Ends: 10/26/
2020, Contact: Ken Tu 303–275–5156.
EIS No. 20200192, Final Supplement,
FDOT, FHWA, FL, Tampa Interstate
Study, Contact: Luis D. Lopez Rivera
407–867–6420. Pursuant to U.S.C.
139(n)(2), FHWA has issued a single
document that consists of a final
supplemental environmental impact
statement and record of decision.
Therefore, the 30-day wait/review
period under NEPA does not apply to
this action.
VerDate Sep<11>2014
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Amended Notice
EIS No. 20200168, Draft, FAA, CA, Bob
Hope Hollywood Burbank Airport
Replacement Passenger Terminal
Project, Comment Period Ends: 10/27/
2020, Contact: Edvige B. Mbakoup
424–405–7283. Revision to FR Notice
Published 8/21/2020; Extending the
Comment Period from 10/5/2020 to
10/27/2020.
EIS No. 20200182, Final, USFS, AZ,
WITHDRAWN—Fossil Creek Wild
and Scenic River Comprehensive
River Management Plan, Contact:
Mike Dechter 928–527–3416. Revision
to FR Notice Published 09/18/2020;
Officially Withdrawn per request of
the submitting agency.
Dated: September 21, 2020.
Cindy S. Barger,
Director, NEPA Compliance Division, Office
of Federal Activities.
[FR Doc. 2020–21174 Filed 9–24–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2020–0390; FRL–10014–21]
Ortho-Phthalaldehyde; Receipt of
Application for Emergency Exemption,
Solicitation of Public Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA has received a specific
exemption request from the National
Aeronautics and Space Administration
(NASA) to use the pesticide orthophthalaldehyde (OPA, CAS No. 643–79–
8) to treat the coolant fluid of the
internal active thermal control system of
the International Space Station to
control aerobic/microaerophilic bacteria
in the aqueous coolant. The applicant
proposes the use of a new chemical
which has not been registered by EPA.
Therefore, in accordance with the Code
of Federal Regulations (CFR), EPA is
soliciting public comment before
making the decision whether to grant
the exemption.
DATES: Comments must be received on
or before October 13, 2020.
SUMMARY:
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Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0390, by
one of the following methods:
• Federal eRulemaking Portal: 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.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION: In
accordance with the regulations at 40
CFR 166.24(a)(1), EPA is soliciting
public comment before making the
decision whether to grant the
exemption.
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are a pesticide
manufacturer (North American
Industrial Classification System
(NAICS) (Code 32532) or involved with
the International Space Station. This
listing is not intended to be exhaustive,
but rather provides a guide to help
readers determine whether this
document applies to them. Other types
of entities not listed could also be
affected.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
www.regulations.gov or email. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
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]]>Agencies
[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60456-60458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21133]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0237; FRL-10014-87]
Cyclic Aliphatic Bromide Cluster (HBCD); Final Toxic Substances
Control Act (TSCA) Risk Evaluation; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of Cyclic Aliphatic Bromide Cluster (HBCD). The purpose of
conducting risk evaluations under TSCA is to determine whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use, including an unreasonable
risk to a relevant potentially exposed or susceptible subpopulation,
without consideration of costs or other nonrisk factors. EPA has
determined that specific conditions of use of HBCD present an
unreasonable risk of injury to health or the environment. For those
conditions of use for which EPA has found an unreasonable risk, EPA
must take regulatory action to address that unreasonable risk through
risk management measures enumerated in TSCA. EPA has also determined
that specific conditions of use do not present unreasonable risk of
injury to health or the environment. For those conditions of use for
which EPA has found no unreasonable risk to health or the environment,
the Agency's determination is a final Agency action and is issued via
order in the 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), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. 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 Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room is closed to visitors
with limited exceptions. The EPA/DC staff continue to provide remote
customer service via email, phone, and webform. 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: Dr.
Stan Barone, Office of Pollution Prevention and Toxics (7403M),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-1169; 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. General Information
A. Does this action apply to me?
This action is directed to the public in general. This action may
be of interest to persons who are or may be interested in risk
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be interested in this final risk
evaluation, 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 nonrisk 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). TSCA section 6(i) directs that a determination
of ``no unreasonable risk'' shall be issued by order and considered to
be a final Agency action, while a determination of ``unreasonable
risk'' is not considered to be a final Agency action. 15 U.S.C.
2605(i).
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
[[Page 60457]]
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)-(ii) and (iv)-(v). Each risk evaluation must not
consider costs or other nonrisk factors. 15 U.S.C. 2605(b)(4)(F)(iii).
The statute requires that the risk evaluation process be completed
within a specified timeframe and provide an opportunity for public
comment on a draft risk evaluation prior to publishing a final risk
evaluation. 15 U.S.C. 2605(b)(4).
Subsection 5.4.1 of the final risk evaluation for HBCD constitutes
the order required under TSCA section 6(i)(1), and the ``no
unreasonable risk'' determinations in that subsection are considered to
be a final Agency action effective on the date of issuance of the
order. In conducting risk evaluations, ``EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of use within the scope of the
risk evaluation. . .'' 40 CFR 702.47. Under EPA's implementing
regulations, ``[a] determination by EPA that the chemical substance,
under one or more of the conditions of use within the scope of the risk
evaluation, does not present an unreasonable risk of injury to health
or the environment will be issued by order and considered to be a final
Agency action, effective on the date of issuance of the order.'' 40 CFR
702.49(d). For purposes of TSCA section 19(a)(1)(A), the date of
issuance of the section 6(i)(1) order for HBCD shall be at 1:00 p.m.
Eastern time (standard or daylight, as appropriate) on the date that is
two weeks after the date when this notice is published in the Federal
Register, which is in accordance with 40 CFR 23.5.
C. What action is EPA taking?
EPA is announcing the availability of the risk evaluation of the
chemical substance identified in Unit II. In this risk evaluation EPA
has made unreasonable risk determinations on some of the conditions of
use within the scope of the risk evaluation for this chemical. For
those conditions of use for which EPA has found an unreasonable risk of
injury to health or the environment, EPA must take regulatory action to
address those risks through risk management measures enumerated in 15
U.S.C. 2605(a).
EPA also is announcing the availability of the information required
to be provided publicly with each risk evaluation, which is available
online at https://www.regulations.gov in the dockets identified. 40 CFR
702.51. Specifically, EPA has provided:
The scope document and problem formulation (in Docket ID
No. EPA-HQ-OPPT-2016-0735);
Draft risk evaluation, and final risk evaluation (in
Docket ID No. EPA-HQ-OPPT-2019-0237);
All notices, determinations, findings, consent agreements,
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0237);
Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0735 and Docket
ID No. EPA-HQ-OPPT-2019-0237);
A nontechnical summary of the risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2019-0237);
A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for
Cyclic Aliphatic Bromide Cluster (HBCD Cluster) in Docket ID No. EPA-
HQ-OPPT-2019-0237);
The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
ID No. EPA-HQ-OPPT-2019-0237); and
Response to public comments received on the draft scope
and the draft risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0237).
II. TSCA Risk Evaluation
A. What is EPA's risk evaluation process for existing chemicals under
TSCA?
The risk evaluation process is the second step in EPA's existing
chemical review process under TSCA, following prioritization and before
risk management. As this chemical is one of the first ten chemical
substances undergoing risk evaluation, the chemical substance was not
required to go through prioritization (81 FR 91927, December 19, 2016)
(FRL-9956-47). The purpose of conducting risk evaluations is to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, not consider costs or other nonrisk factors,
use reasonably available information and approaches in a manner that is
consistent with the requirements in TSCA for the use of the best
available science, and ensure decisions are based on the weight of
scientific evidence.
The specific risk evaluation process that EPA has established by
rule to implement the statutory process is set out in 40 CFR part 702
and summarized on EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B is being followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
Prior to the publication of this final risk evaluation, a draft
risk evaluation was subject to peer review and public comment. EPA
reviewed the report from the peer review committee and public comments
and has amended the risk evaluation in response to these comments as
appropriate. The public comments, peer review report, and EPA's
response to comments is in Docket ID No. EPA-HQ-OPPT-2019-0237. Prior
to the publication of the draft risk evaluation, EPA made available the
scope and problem formulation, and solicited public input on uses and
exposure. EPA's documents and the public comments are in Docket ID No.
EPA-HQ-OPPT-2016-0735. Additionally, information about the scope,
problem formulation, and draft risk evaluation phases of the TSCA risk
evaluation for this chemical is at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-cyclic-aliphatic-bromide-cluster-hbcd.
B. What is Cyclic Aliphatic Bromide Cluster (HBCD Cluster)?
The cyclic aliphatic bromide cluster chemicals, including
hexabromocyclododecane (HBCD), are flame retardants. Other uses include
use as a component of solder and use in automobile replacement parts.
EPA has not identified reasonably available information to suggest that
HBCD is currently domestically manufactured in
[[Page 60458]]
any quantity. Companies have the ability to import the chemical in low
volumes below the CDR reporting threshold.
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-21133 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P
