[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]



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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]
 BILLING CODE 6560-50-P