Draft Toxic Substances Control Act (TSCA) Risk Evaluations and TSCA Science Advisory Committee on Chemicals (SACC) Meetings; Cyclic Aliphatic Bromide Cluster (HBCD) and 1,4-Dioxane; Notice of Availability and Public Meetings, 31315-31317 [2019-14021]
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Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2019–0237 and EPA–HQ–
OPPT–2019–0238; FRL–9995–40]
Draft Toxic Substances Control Act
(TSCA) Risk Evaluations and TSCA
Science Advisory Committee on
Chemicals (SACC) Meetings; Cyclic
Aliphatic Bromide Cluster (HBCD) and
1,4-Dioxane; Notice of Availability and
Public Meetings
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA announces the
availability of documents and dates for
the peer review of the draft risk
evaluations for Cyclic Aliphatic
Bromide Cluster (HBCD) and 1,4Dioxane, and associated documents.
The purpose of the risk evaluations
under the Toxic Substances Control Act
(TSCA) is to determine whether a
chemical substance presents an
unreasonable risk to health or the
environment under the conditions of
use, including an unreasonable risk to a
relevant potentially exposed or
susceptible subpopulation. EPA is also
submitting these same documents to the
TSCA Science Advisory Committee on
Chemicals (SACC) for peer review and
is announcing that there will be a 5-day
in-person meeting of the TSCA SACC to
consider and review these draft risk
evaluations. Preceding the in-person
meeting, there will be a 3-hour
preparatory virtual meeting for the
panel to consider the scope and clarity
of the draft charge questions for the peer
reviews.
DATES:
Meetings: The preparatory virtual
meeting will be held on July 10, 2019,
from 1 p.m. to approximately 4 p.m.
(EDT). The 5-day in-person meeting will
be held on July 29, 2019 from 1:00 p.m.
to 5:30 p.m. (EDT) and July 30, 2019 to
August 2, 2019 from 9:00 a.m. to
approximately 5:30 p.m. (EDT).
Comments: Comments on the draft
risk evaluations must be received on or
before August 30, 2019. Written
comments for and requests to make oral
comments during the TSCA SACC
meeting must be submitted on or before
July 19, 2019 for consideration by the
TSCA SACC. For additional
instructions, see Unit II.A. and Unit II.B.
of the SUPPLEMENTARY INFORMATION.
ADDRESSES:
Webcast: The preparatory virtual
meeting will be conducted via webcast
and telephone. Registration is required
to participate during the preparatory
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SUMMARY:
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virtual meeting. Please visit https://
www.epa.gov/tsca-peer-review website
for additional information including
how to register. The 5-day in-person
meeting may also be webcast. Please
refer to the TSCA SACC website at
https://www.epa.gov/tsca-peer-review
for information on how to access the
webcast. Please note that for the inperson meeting, the webcast is a
supplementary public process provided
only for convenience. If difficulties arise
resulting in webcasting outages, the inperson meeting will continue as
planned.
In-Person Meeting: The 5-day inperson meeting will be held at the
Holiday Inn Rosslyn at Key Bridge,
Rosslyn Ballroom, 1900 North Fort Myer
Drive, Arlington, VA 22209.
Comments. Submit your comments,
identified by the respective docket
identification (ID) numbers for each
chemical (i.e., Cyclic Aliphatic Bromide
Cluster (HBCD) (EPA–HQ–OPPT–2019–
0237) and 1,4-Dioxane (EPA–HQ–
OPPT–2019–0238)), 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: OPPT 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.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
Requests to present oral comments
and requests for special
accommodations. Submit requests for
special accommodations, or requests to
present oral comments (in-person or
over the telephone) to the DFO listed
under FOR FURTHER INFORMATION
CONTACT.
FOR FURTHER INFORMATION CONTACT:
TSCA SACC meetings: Dr. Todd
Peterson, DFO, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–6428; email address:
peterson.todd@epa.gov.
Risk Evaluations: Dr. Stan Barone,
Office of Pollution Prevention and
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Toxics (7403M), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: 202–564–1169;
email address: barone.stan@epa.gov.
Special accommodations for the
SACC meeting: For information on
access or services for individuals with
disabilities, and to request
accommodation of a disability, please
contact the DFO listed under FOR
FURTHER INFORMATION CONTACT at least
10 days prior to the meeting to give EPA
as much time as possible to process
your request.
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
required to conduct testing and risk
evaluations of chemical substances
under the TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be
interested in these risk evaluations, the
EPA has not attempted to describe all
the specific entities that may be affected
by this action.
B. What action is the EPA taking?
EPA is announcing the availability of
and seeking public comment on the
draft Risk Evaluations for Cyclic
Aliphatic Bromide Cluster (HBCD) and
1,4-Dioxane, and associated documents.
EPA is seeking public comment on all
aspects of these draft risk evaluations,
including any conclusions, findings,
determinations, and the submission of
any additional information that might
be relevant to the science underlying the
risk evaluations and the outcome of the
systematic review associated with
HBCD and 1,4-Dioxane. This 60-day
comment period on the draft risk
evaluations satisfies TSCA section
6(b)(4)(H), which requires EPA to
‘‘provide no less than 30 days public
notice and an opportunity for comment
on a draft risk evaluation prior to
publishing a final risk evaluation’’ and
40 CFR 702.49(a), which states that
‘‘EPA will publish a draft risk
evaluation in the Federal Register, open
a docket to facilitate receipt of public
comment, and provide no less than a 60day comment period, during which time
the public may submit comment on
EPA’s draft risk evaluation.’’ In addition
to any new comments on the draft risk
evaluations, the public should resubmit
or clearly identify any previously filed
comments, modified as appropriate, that
are relevant to these risk evaluations
and that the submitter feels have not
been addressed. EPA does not intend to
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respond to comments submitted prior to
the release of these draft risk
evaluations.
EPA is also submitting these same
documents to the TSCA SACC for peer
review and announcing the meetings for
the peer review panel. All comments
submitted to the dockets for
consideration by the TSCA SACC by the
deadline identified in DATES will be
provided to the TSCA SACC peer
review panel, which will have the
opportunity to consider the comments
during its discussions.
C. What is the 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 direct which
chemical substances must undergo
evaluation, the development of criteria
for manufacturer-requested evaluations,
the minimum components of an EPA
risk evaluation, and the timelines for
public comment and completion of the
risk evaluation. The law also requires
that EPA operate in a manner that is
consistent with the best available
science and make decisions based on
the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i).
The statute identifies the minimum
components EPA must include in 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 exposure
for the conditions of use of the chemical
substance, including information on
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,
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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 exposure. 15 U.S.C.
2605(b)(4)(F)(i)-(ii) and (iv)-(v). The 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 last no longer than
three years, with a possible additional
six-month extension. 15 U.S.C.
2605(b)(4)(G). The statute also requires
that the EPA allow for no less than a 30day public comment period on the draft
risk evaluation, prior to publishing a
final risk evaluation. 15 U.S.C.
2605(b)(4)(H).
II. TSCA SACC Meetings
The focus of the public meeting is to
peer review EPA’s draft risk evaluations
of Cyclic Aliphatic Bromide Cluster
(HBCD) and 1,4-Dioxane. After the peer
review process, EPA will consider
reviewer comments and
recommendations and public
comments, in finalization of the risk
evaluations. The draft risk evaluations
contain: Discussion of chemistry and
physical-chemical properties;
characterization of uses/sources;
environmental fate and transport
assessment; engineering release(s) and
occupational exposure assessment;
general population, consumer and
environmental exposure assessment;
human health hazard assessment;
environmental hazard assessment; risk
characterization; risk determination;
and a detailed description of the
systematic review process developed by
the Office of Pollution Prevention and
Toxics to search, screen, and evaluate
scientific literature for use in the risk
evaluation process.
A. How may I participate in the inperson meeting?
You may participate in the 5-day in
person meeting by following the
instructions in this unit. To ensure
proper receipt by EPA, it is imperative
that you identify the corresponding
docket ID numbers for Cyclic Aliphatic
Bromide Cluster (HBCD) (EPA–HQ–
OPPT–2019–0237) and 1,4-Dioxane
(EPA–HQ–OPPT–2019–0238) in the
subject line on the first page of your
request.
1. Written comments. To provide
TSCA SACC the time necessary to
consider and review your comments,
written comments must be submitted by
the date outlined in the DATES section
and using the instructions in ADDRESSES
and Unit II.C.
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2. Oral comments. In order to be
included on the meeting agenda, submit
your request to make brief oral
comments to the TSCA SACC during the
in-person meeting to the DFO listed
under FOR FURTHER INFORMATION
CONTACT on or before the date outlined
in the DATES section. The request should
identify the name of the individual
making the presentation, the
organization (if any) the individual will
represent, and any requirements for
audiovisual equipment. Oral comments
before TSCA SACC during the in-person
meeting are limited to approximately 5
minutes unless prior arrangements have
been made. In addition, each speaker
should bring 30 copies of his or her
comments and presentation for
distribution to TSCA SACC at the
meeting by the DFO.
3. Seating at the meeting. Seating at
the meeting will be open and on a firstcome basis.
B. How may I participate in the
preparatory virtual meeting?
Registration for the July 10, 2019,
preparatory virtual meeting is required.
To participate by listening or making a
comment during this meeting, please
visit: https://www.epa.gov/tsca-peerreview website to register. Registration
online will be confirmed by email that
will include the webcast meeting link
and audio teleconference information.
1. Written comments. Written
comments for consideration during the
preparatory virtual meeting should be
submitted, using the instructions in
ADDRESSES and Unit II.C., on or before
July 9, 2019.
2. Oral comments. Requests to make
brief oral comments to the TSCA SACC
during the preparatory virtual meeting
should be submitted when registering
online or with the DFO listed under FOR
FURTHER INFORMATION CONTACT on or
before noon on July 9, 2019. Oral
comments before TSCA SACC during
the preparatory webcast are limited to
approximately 5 minutes due to the
time constraints of this webcast.
3. Webcast. The preparatory virtual
meeting will be webcast only, and will
be open to the public. Please refer to the
TSCA SACC website at https://
www.epa.gov/tsca-peer-review for
information on how to access the
webcast. Registration is required.
C. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit CBI
information to EPA through
regulations.gov or email. If your
comments contain any information that
you consider to be CBI or otherwise
protected, please contact the DFO listed
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Federal Register / Vol. 84, No. 126 / Monday, July 1, 2019 / Notices
under FOR FURTHER INFORMATION
CONTACT to obtain special instructions
before submitting your comments.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
III. Background
A. What is EPA’s risk evaluation process
for existing chemicals under TSCA?
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The risk evaluation process is the
second step in EPA’s existing chemical
process under TSCA, following
prioritization and before risk
management. As these two chemicals
are part of the first ten chemical
substances undergoing risk evaluation,
the chemical substances that are the
subject of this announcement were
designated for risk evaluation and were
not required to go through prioritization
(81 FR 91927, December 19, 2016)
(FRL–9956–47). The purpose of risk
evaluation is to determine whether a
chemical substance presents an
unreasonable risk 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 non-risk factors, use scientific
information and approaches in a
manner that is consistent with the
requirements in TSCA for the best
available science, and ensure decisions
are based on the weight-of-scientificevidence.
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 will be followed for the first
ten chemical substances undergoing risk
evaluation to the maximum extent
practicable.
B. What is cyclic aliphatic bromide
cluster (HBCD)?
The hexabromocyclodecanes (HBCD
cluster) in the cyclic aliphatic bromide
cluster consists of the following
chemicals: Hexabromocyclododecane;
1,2,5,6,9,10-Hexabromocyclododecane;
and 1,2,5,6-Tetrabromocyclooctane.
HBCD is a flame retardant and is
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primarily used in construction
materials, which may include structural
insulated panels (SIPS). The building
and construction industry uses
expanded polystyrene foam (EPS) and
extruded polystyrene foam (XPS) for
thermal insulation boards and laminates
for sheathing products. HBCD is also
used in replacement parts for vehicles
and in solder paste. Data reported for
the 2016 Chemical Data Reporting
period for HBCD indicate that between
1 and 10 million lb of each chemical
component were manufactured in or
imported into the U.S. in 2015;
however, domestic manufacture of
HBCD has since ceased.
Information about the problem
formulation and scope phases of the risk
evaluation for this chemical is available
at https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/riskevaluation-cyclic-aliphatic-bromidecluster-hbcd.
C. What is 1,4-dioxane?
1,4-Dioxane is used primarily as a
solvent in industrial and commercial
processes, such as in the manufacture of
other chemicals, as a processing aid, a
laboratory chemical reagent, and in
adhesives and sealants. Historically,
90% of 1,4-dioxane production was
used as a stabilizer in chlorinated
solvents such as 1,1,1-trichloroethane
(TCA). The 2016 Chemical Data
Reporting data shows that there were
two manufacturers producing or
importing over 1 million pounds in the
U.S. in 2015.
Information about the problem
formulation and scope phases of the risk
evaluation for this chemical is available
at https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/riskevaluation-14-dioxane.
D. What is the purpose of the TSCA
SACC?
The TSCA SACC was established by
EPA in 2016 and operates in accordance
with the Federal Advisory Committee
Act (FACA), 5 U.S.C Appendix 2 et seq.
The SACC supports activities under
TSCA, the Pollution Prevention Act
(PPA), 42 U.S.C. 13101 et seq., and other
applicable statutes. The TSCA SACC
provides expert independent scientific
advice and recommendations to the EPA
on the scientific and technical aspects of
risk assessments, methodologies, and
pollution prevention measures and
approaches for chemicals regulated
under TSCA.
The TSCA SACC is comprised of
experts in: Toxicology; human health
and environmental risk assessment;
exposure assessment; and related
sciences (e.g., synthetic biology,
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31317
pharmacology, biotechnology,
nanotechnology, biochemistry,
biostatistics, PBPK modeling,
computational toxicology,
epidemiology, environmental fate, and
environmental engineering and
sustainability). The TSCA SACC
currently consists of 24 members. When
needed, the committee will be assisted
in their reviews by ad hoc participants
with specific expertise in the topics
under consideration.
E. TSCA SACC Documents and Meeting
Minutes
EPA’s background paper, related
supporting materials, and draft charge/
questions to TSCA SACC are available
on the TSCA SACC website and in the
dockets for Cyclic Aliphatic Bromide
Cluster (HBCD) (EPA–HQ–OPPT–2019–
0237) and 1,4 Dioxane (EPA–HQ–
OPPT–2019–0238). In addition, the EPA
will provide additional background
documents (e.g., TSCA SACC members
participating in this meeting and the
meeting agenda) as the materials
become available. You may obtain
electronic copies of these documents,
and certain other related documents that
might be available, at https://
www.regulations.gov and the TSCA
SACC website at https://www.epa.gov/
tsca-peer-review.
TSCA SACC will prepare meeting
minutes summarizing its
recommendations to the EPA. The
meeting minutes will be posted on the
TSCA SACC website and in the relevant
dockets.
Authority: 15 U.S.C. 2601 et seq.; 15
U.S.C. 2625 et. seq.; 5 U.S.C Appendix 2 et.
seq.
Dated: June 25, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019–14021 Filed 6–28–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9995–56–OP]
National Environmental Justice
Advisory Council; Notification of
Public Teleconference and Public
Comment
Environmental Protection
Agency (EPA).
ACTION: Notification of public
teleconference meeting.
AGENCY:
Pursuant to the Federal
Advisory Committee Act (FACA), the
U.S. Environmental Protection Agency
(EPA) hereby provides notice that the
SUMMARY:
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Agencies
[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Notices]
[Pages 31315-31317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14021]
[[Page 31315]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0237 and EPA-HQ-OPPT-2019-0238; FRL-9995-40]
Draft Toxic Substances Control Act (TSCA) Risk Evaluations and
TSCA Science Advisory Committee on Chemicals (SACC) Meetings; Cyclic
Aliphatic Bromide Cluster (HBCD) and 1,4-Dioxane; Notice of
Availability and Public Meetings
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA announces the availability of documents and dates for the
peer review of the draft risk evaluations for Cyclic Aliphatic Bromide
Cluster (HBCD) and 1,4-Dioxane, and associated documents. The purpose
of the risk evaluations under the Toxic Substances Control Act (TSCA)
is to determine whether a chemical substance presents an unreasonable
risk to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. EPA is also submitting these same documents
to the TSCA Science Advisory Committee on Chemicals (SACC) for peer
review and is announcing that there will be a 5-day in-person meeting
of the TSCA SACC to consider and review these draft risk evaluations.
Preceding the in-person meeting, there will be a 3-hour preparatory
virtual meeting for the panel to consider the scope and clarity of the
draft charge questions for the peer reviews.
DATES:
Meetings: The preparatory virtual meeting will be held on July 10,
2019, from 1 p.m. to approximately 4 p.m. (EDT). The 5-day in-person
meeting will be held on July 29, 2019 from 1:00 p.m. to 5:30 p.m. (EDT)
and July 30, 2019 to August 2, 2019 from 9:00 a.m. to approximately
5:30 p.m. (EDT).
Comments: Comments on the draft risk evaluations must be received
on or before August 30, 2019. Written comments for and requests to make
oral comments during the TSCA SACC meeting must be submitted on or
before July 19, 2019 for consideration by the TSCA SACC. For additional
instructions, see Unit II.A. and Unit II.B. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES:
Webcast: The preparatory virtual meeting will be conducted via
webcast and telephone. Registration is required to participate during
the preparatory virtual meeting. Please visit https://www.epa.gov/tsca-peer-review website for additional information including how to
register. The 5-day in-person meeting may also be webcast. Please refer
to the TSCA SACC website at https://www.epa.gov/tsca-peer-review for
information on how to access the webcast. Please note that for the in-
person meeting, the webcast is a supplementary public process provided
only for convenience. If difficulties arise resulting in webcasting
outages, the in-person meeting will continue as planned.
In-Person Meeting: The 5-day in-person meeting will be held at the
Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort
Myer Drive, Arlington, VA 22209.
Comments. Submit your comments, identified by the respective docket
identification (ID) numbers for each chemical (i.e., Cyclic Aliphatic
Bromide Cluster (HBCD) (EPA-HQ-OPPT-2019-0237) and 1,4-Dioxane (EPA-HQ-
OPPT-2019-0238)), 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: OPPT 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.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
Requests to present oral comments and requests for special
accommodations. Submit requests for special accommodations, or requests
to present oral comments (in-person or over the telephone) to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
TSCA SACC meetings: Dr. Todd Peterson, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-6428; email address: [email protected].
Risk Evaluations: 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].
Special accommodations for the SACC meeting: For information on
access or services for individuals with disabilities, and to request
accommodation of a disability, please contact the DFO listed under FOR
FURTHER INFORMATION CONTACT at least 10 days prior to the meeting to
give EPA as much time as possible to process your request.
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 required to conduct testing
and risk evaluations of chemical substances under the TSCA, 15 U.S.C.
2601 et seq. Since other entities may also be interested in these risk
evaluations, the EPA has not attempted to describe all the specific
entities that may be affected by this action.
B. What action is the EPA taking?
EPA is announcing the availability of and seeking public comment on
the draft Risk Evaluations for Cyclic Aliphatic Bromide Cluster (HBCD)
and 1,4-Dioxane, and associated documents. EPA is seeking public
comment on all aspects of these draft risk evaluations, including any
conclusions, findings, determinations, and the submission of any
additional information that might be relevant to the science underlying
the risk evaluations and the outcome of the systematic review
associated with HBCD and 1,4-Dioxane. This 60-day comment period on the
draft risk evaluations satisfies TSCA section 6(b)(4)(H), which
requires EPA to ``provide no less than 30 days public notice and an
opportunity for comment on a draft risk evaluation prior to publishing
a final risk evaluation'' and 40 CFR 702.49(a), which states that ``EPA
will publish a draft risk evaluation in the Federal Register, open a
docket to facilitate receipt of public comment, and provide no less
than a 60-day comment period, during which time the public may submit
comment on EPA's draft risk evaluation.'' In addition to any new
comments on the draft risk evaluations, the public should resubmit or
clearly identify any previously filed comments, modified as
appropriate, that are relevant to these risk evaluations and that the
submitter feels have not been addressed. EPA does not intend to
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respond to comments submitted prior to the release of these draft risk
evaluations.
EPA is also submitting these same documents to the TSCA SACC for
peer review and announcing the meetings for the peer review panel. All
comments submitted to the dockets for consideration by the TSCA SACC by
the deadline identified in DATES will be provided to the TSCA SACC peer
review panel, which will have the opportunity to consider the comments
during its discussions.
C. What is the 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 direct which
chemical substances must undergo evaluation, the development of
criteria for manufacturer-requested evaluations, the minimum components
of an EPA risk evaluation, and the timelines for public comment and
completion of the risk evaluation. The law also requires that EPA
operate in a manner that is consistent with the best available science
and make decisions based on the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i).
The statute identifies the minimum components EPA must include in
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 exposure for the conditions of use
of the chemical substance, including information on 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 exposure. 15 U.S.C.
2605(b)(4)(F)(i)-(ii) and (iv)-(v). The 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 last no
longer than three years, with a possible additional six-month
extension. 15 U.S.C. 2605(b)(4)(G). The statute also requires that the
EPA allow for no less than a 30-day public comment period on the draft
risk evaluation, prior to publishing a final risk evaluation. 15 U.S.C.
2605(b)(4)(H).
II. TSCA SACC Meetings
The focus of the public meeting is to peer review EPA's draft risk
evaluations of Cyclic Aliphatic Bromide Cluster (HBCD) and 1,4-Dioxane.
After the peer review process, EPA will consider reviewer comments and
recommendations and public comments, in finalization of the risk
evaluations. The draft risk evaluations contain: Discussion of
chemistry and physical-chemical properties; characterization of uses/
sources; environmental fate and transport assessment; engineering
release(s) and occupational exposure assessment; general population,
consumer and environmental exposure assessment; human health hazard
assessment; environmental hazard assessment; risk characterization;
risk determination; and a detailed description of the systematic review
process developed by the Office of Pollution Prevention and Toxics to
search, screen, and evaluate scientific literature for use in the risk
evaluation process.
A. How may I participate in the in-person meeting?
You may participate in the 5-day in person meeting by following the
instructions in this unit. To ensure proper receipt by EPA, it is
imperative that you identify the corresponding docket ID numbers for
Cyclic Aliphatic Bromide Cluster (HBCD) (EPA-HQ-OPPT-2019-0237) and
1,4-Dioxane (EPA-HQ-OPPT-2019-0238) in the subject line on the first
page of your request.
1. Written comments. To provide TSCA SACC the time necessary to
consider and review your comments, written comments must be submitted
by the date outlined in the DATES section and using the instructions in
ADDRESSES and Unit II.C.
2. Oral comments. In order to be included on the meeting agenda,
submit your request to make brief oral comments to the TSCA SACC during
the in-person meeting to the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before the date outlined in the DATES section. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment. Oral comments before
TSCA SACC during the in-person meeting are limited to approximately 5
minutes unless prior arrangements have been made. In addition, each
speaker should bring 30 copies of his or her comments and presentation
for distribution to TSCA SACC at the meeting by the DFO.
3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
B. How may I participate in the preparatory virtual meeting?
Registration for the July 10, 2019, preparatory virtual meeting is
required. To participate by listening or making a comment during this
meeting, please visit: https://www.epa.gov/tsca-peer-review website to
register. Registration online will be confirmed by email that will
include the webcast meeting link and audio teleconference information.
1. Written comments. Written comments for consideration during the
preparatory virtual meeting should be submitted, using the instructions
in ADDRESSES and Unit II.C., on or before July 9, 2019.
2. Oral comments. Requests to make brief oral comments to the TSCA
SACC during the preparatory virtual meeting should be submitted when
registering online or with the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before noon on July 9, 2019. Oral comments before TSCA
SACC during the preparatory webcast are limited to approximately 5
minutes due to the time constraints of this webcast.
3. Webcast. The preparatory virtual meeting will be webcast only,
and will be open to the public. Please refer to the TSCA SACC website
at https://www.epa.gov/tsca-peer-review for information on how to access
the webcast. Registration is required.
C. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed
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under FOR FURTHER INFORMATION CONTACT to obtain special instructions
before submitting your comments.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
III. Background
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 process under TSCA, following prioritization and before risk
management. As these two chemicals are part of the first ten chemical
substances undergoing risk evaluation, the chemical substances that are
the subject of this announcement were designated for risk evaluation
and were not required to go through prioritization (81 FR 91927,
December 19, 2016) (FRL-9956-47). The purpose of risk evaluation is to
determine whether a chemical substance presents an unreasonable risk 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 non-risk factors, use
scientific information and approaches in a manner that is consistent
with the requirements in TSCA for 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 will be followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
B. What is cyclic aliphatic bromide cluster (HBCD)?
The hexabromocyclodecanes (HBCD cluster) in the cyclic aliphatic
bromide cluster consists of the following chemicals:
Hexabromocyclododecane; 1,2,5,6,9,10-Hexabromocyclododecane; and
1,2,5,6-Tetrabromocyclooctane. HBCD is a flame retardant and is
primarily used in construction materials, which may include structural
insulated panels (SIPS). The building and construction industry uses
expanded polystyrene foam (EPS) and extruded polystyrene foam (XPS) for
thermal insulation boards and laminates for sheathing products. HBCD is
also used in replacement parts for vehicles and in solder paste. Data
reported for the 2016 Chemical Data Reporting period for HBCD indicate
that between 1 and 10 million lb of each chemical component were
manufactured in or imported into the U.S. in 2015; however, domestic
manufacture of HBCD has since ceased.
Information about the problem formulation and scope phases of the
risk evaluation for this chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-cyclic-aliphatic-bromide-cluster-hbcd.
C. What is 1,4-dioxane?
1,4-Dioxane is used primarily as a solvent in industrial and
commercial processes, such as in the manufacture of other chemicals, as
a processing aid, a laboratory chemical reagent, and in adhesives and
sealants. Historically, 90% of 1,4-dioxane production was used as a
stabilizer in chlorinated solvents such as 1,1,1-trichloroethane (TCA).
The 2016 Chemical Data Reporting data shows that there were two
manufacturers producing or importing over 1 million pounds in the U.S.
in 2015.
Information about the problem formulation and scope phases of the
risk evaluation for this chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-14-dioxane.
D. What is the purpose of the TSCA SACC?
The TSCA SACC was established by EPA in 2016 and operates in
accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C
Appendix 2 et seq. The SACC supports activities under TSCA, the
Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other
applicable statutes. The TSCA SACC provides expert independent
scientific advice and recommendations to the EPA on the scientific and
technical aspects of risk assessments, methodologies, and pollution
prevention measures and approaches for chemicals regulated under TSCA.
The TSCA SACC is comprised of experts in: Toxicology; human health
and environmental risk assessment; exposure assessment; and related
sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, PBPK modeling,
computational toxicology, epidemiology, environmental fate, and
environmental engineering and sustainability). The TSCA SACC currently
consists of 24 members. When needed, the committee will be assisted in
their reviews by ad hoc participants with specific expertise in the
topics under consideration.
E. TSCA SACC Documents and Meeting Minutes
EPA's background paper, related supporting materials, and draft
charge/questions to TSCA SACC are available on the TSCA SACC website
and in the dockets for Cyclic Aliphatic Bromide Cluster (HBCD) (EPA-HQ-
OPPT-2019-0237) and 1,4 Dioxane (EPA-HQ-OPPT-2019-0238). In addition,
the EPA will provide additional background documents (e.g., TSCA SACC
members participating in this meeting and the meeting agenda) as the
materials become available. You may obtain electronic copies of these
documents, and certain other related documents that might be available,
at https://www.regulations.gov and the TSCA SACC website at https://www.epa.gov/tsca-peer-review.
TSCA SACC will prepare meeting minutes summarizing its
recommendations to the EPA. The meeting minutes will be posted on the
TSCA SACC website and in the relevant dockets.
Authority: 15 U.S.C. 2601 et seq.; 15 U.S.C. 2625 et. seq.; 5
U.S.C Appendix 2 et. seq.
Dated: June 25, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-14021 Filed 6-28-19; 8:45 am]
BILLING CODE 6560-50-P