[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Notices]
[Pages 39830-39833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17222]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0235; FRL-9997-25]


1-Bromopropane (1-BP); Draft Toxic Substances Control Act (TSCA) 
Risk Evaluation and TSCA Science Advisory Committee on Chemicals (SACC) 
Meetings; Notice of Availability and Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of documents and dates for 
the peer review of the draft risk evaluation for 1-Bromopropane (1-BP). 
The purpose of the risk evaluations under the Toxic Substances Control 
Act (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. 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 3-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: 
    Comments: Comments on the draft risk evaluation must be received on 
or before October 11, 2019. Please submit comments on the draft risk 
evaluation by August 30, 2019 to allow the SACC time to review and 
consider them before the peer review meeting. Comments received after 
August 30, 2019 will still be provided to the SACC for their 
consideration. For additional instructions, see Unit II.A. and Unit 
II.B. of the SUPPLEMENTARY INFORMATION.
    Meetings: The preparatory virtual meeting will be held on August 
21, 2019, from 1 p.m. to approximately 4 p.m. (EDT). The 3-day in-
person meeting will be held on September 10-12, 2019 from 9:00 a.m. to 
approximately 5:30 p.m. (EDT).

ADDRESSES: Virtual Meeting: The preparatory virtual meeting will be 
conducted via webcast and telephone. Registration is open to the public 
and 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.
    In-Person Meeting: The location of the in-person meeting will be 
announced on the TSCA SACC website at http://www.epa.gov/TSCA-Peer-Review. The 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.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0235, by one of the following methods:

[[Page 39831]]

     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) during the 
webcast and/or the public portion of the peer review meeting to the 
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION 
CONTACT by the deadline identified in the DATES section. Comments 
received after the date set in the DATES section and prior to the end 
of the oral public comment period during the meeting for each chemical 
will still be provided to the SACC for their consideration.

FOR FURTHER INFORMATION CONTACT: TSCA SACC meetings: Tamue Gibson, DFO, 
Office of Science Coordination and Policy (7201M), Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-7642; email address: 
gibson.tamue@epa.gov.
    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: 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 evaluation for 1-Bromopropane (1-BP). EPA is seeking 
public comment on all aspects of the draft risk evaluation, including 
any conclusions, findings, and determinations, and the submission of 
any additional information that might be relevant to the science 
underlying the risk evaluation and the outcome of the systematic review 
associated with the chemical. 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 evaluation, the public should resubmit or clearly identify 
any previously filed comments, modified as appropriate, that are 
relevant to the draft risk evaluation and that the submitter feels have 
not been addressed. EPA does not intend to respond to comments 
submitted prior to the release of the draft risk evaluation unless they 
are clearly identified in comments on the draft risk evaluation.
    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 the DATES section 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). 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 last no 
longer than three years, with a possible additional six-month 
extension. 15 U.S.C.

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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 
evaluation of 1-BP. After the peer review process, EPA will consider 
peer reviewer comments and recommendations and public comments, in 
finalizing the risk evaluation. The draft risk evaluation contains: 
discussion of chemistry and physical-chemical properties; 
characterization of conditions of use; environmental fate and transport 
assessment; human health exposures; 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 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 number for 1-
BP (EPA-HQ-OPPT-2019-0235) 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 set in the DATES section and using the instructions in the 
ADDRESSES section and Unit II.C. Comments received after the date set 
in the DATES section and prior to the end of the oral public comment 
period during the meeting for each chemical will still be provided to 
the SACC for their consideration.
    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 by the DFO to the TSCA SACC at the meeting.
    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 August 21, 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 August 20, 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 August 20, 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 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 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 this chemical is part 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 risk evaluation 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 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 1-Bromopropane?

    1-Bromopropane (1-BP) is primarily used as a solvent cleaner in 
vapor and immersion degreasing operations to clean optics, electronics 
and metals, and it has also been reported to be used as a solvent 
vehicle in industries using spray adhesives such as those used in foam 
cushion manufacturing. Information from the 2016 Chemical Data 
Reporting (CDR) for 1-BP indicates the reported production volume is 
25.9 million lbs/year (manufacture and import).
    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-1-bromopropane-1-bp.

C. 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

[[Page 39833]]

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.

D. 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 docket established for the specific chemical. 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 docket.

    Authority: 15 U.S.C. 2601 et seq.; 5 U.S.C. Appendix 2 et seq.

    Dated: August 5, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-17222 Filed 8-9-19; 8:45 am]
 BILLING CODE 6560-50-P


