[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.
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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: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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 http://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 http://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 http://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]
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