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Environmental Protection Agency (EPA).
This notice announces the peer review of the draft Risk Evaluation for Colour Index (C.I.) Pigment Violet 29 (PV29) and associated documents developed under EPA's existing chemical substance process under the Toxic Substances Control Act (TSCA). The peer review panel deliberations will be conducted during a 4-day, in-person, public meeting of the TSCA Science Advisory Committee on Chemicals (SACC). This in-person meeting will also include a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public for the committee's discussion of information claimed as confidential business information (CBI). Prior to the in-person meeting, there will be a public, 2-hour preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review. During these upcoming meetings, the public is invited to provide oral comments for the peer review on the draft risk evaluation for PV29 and related documents. Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting. The TSCA SACC peer review panel will consider these comments during their discussions.
Meetings: The preparatory virtual meeting will be held on January 8, 2019, from 2 p.m. to approximately 4 p.m. (EST). The 4-day in-person meeting will be held from 1 p.m. (EST) to approximately 5:30 p.m. on January 29, 2019 and from 9 a.m. to approximately 5:30 p.m. on January 30, 31, and February 1, 2019.
Oral comments: Requests to make oral comments during the preparatory virtual meeting should be submitted on or before 12:00 p.m. (EST) on January 4, 2019. In order to be included on the meeting agenda, requests to make oral comments during the in-person 4-day peer review meeting should be submitted on or before January 14, 2019. Otherwise, requests to present oral comments during the in-person 4-day peer review meeting will be accepted until and possibly during the in-person meeting. Direct your requests to make oral comments to the Designated Federal Officer (DFO) listed under FOR FURTHER INFORMATION CONTACT.
For additional instructions, see Unit I.C. and Unit I.D. of the SUPPLEMENTARY INFORMATION.
Written comments: Written comments on the scope and clarity of the draft charge questions for the preparatory virtual meeting should be submitted on or before January 7, 2019. Written comments on the draft risk evaluation that are submitted on or before January 14, 2019 (see 83 FR 57473, November 15, 2018) (FRL-9986-45) will be provided to the peer review panel members before the meeting. You may also submit written comments on the first date of the in-person 4-day peer review meeting by providing 30 copies of your written comments to the DFO at the start of the meeting for the DFO to distribute to the panel members. The TSCA SACC will consider written comments during their discussions.
Special accommodations: 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.
Preparatory Virtual Meeting: The January 8, 2019 preparatory virtual meeting is open to the public and will be conducted via webcast using Adobe Connect and telephone. Registration is required to participate by listening or presenting oral comments 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 January 29 to February 1, 2019 in-person meeting will be announced on the TSCA SACC website (https://www.epa.gov/tsca-peer-review) by mid-December 2018. The January 29 to February 1, 2019 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 for the peer review: Submit your written comments for the peer review, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0604, 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 to present oral comments or for special accommodations, to the DFO listed under FOR FURTHER INFORMATION CONTACT.
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FOR FURTHER INFORMATION CONTACT:
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@example.com.
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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 interested in risk evaluations of chemical substances under the Toxic Substances Control Act (TSCA). Since other entities may also be interested in this risk evaluation, the Agency has not attempted to describe all the specific entities that may be affected by this action.
B. 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 via 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 Start Printed Page 61630comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
C. How may I participate in the preparatory virtual meeting?
1. Register. Registration for the January 8, 2019, preparatory virtual meeting is required. To participate by listening or making oral comments during this meeting please visit https://www.epa.gov/tsca-peer-review to register. Registration online will be confirmed by email that will include the webcast meeting Adobe Connect link and audio teleconference information.
2. Submit written comments. Written comments for the preparatory virtual meeting should be submitted, using the instructions in ADDRESSES and Unit I.B., on or before January 7, 2019. Written comments should focus on the scope and clarity of the draft charge questions and the TSCA SACC will consider those comments during their discussions.
3. Provide oral comments. To provide oral comments at the virtual meeting, please follow the applicable instructions to register on or before 12:00 p.m. (EST) on January 4, 2019. Oral comments to the TSCA SACC panel during the preparatory virtual meeting are limited to approximately 5 minutes due to the time limit of this meeting. Oral comments should focus on the scope and clarity of the draft charge questions and the panel will consider those comments during their discussions.
4. Participate in the virtual meeting. Follow the instructions in Unit I.C.1. to register for the January 8, 2019 preparatory meeting. Your confirmation will include the webcast meeting Adobe Connect link and audio teleconference information.
D. How may I participate in the in-person meeting?
You may participate in the in-person peer review meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPPT-2018-0604 in the subject line on the first page of your request.
1. Provide oral comments for the peer review. The Agency encourages each individual or group wishing to make brief oral comments to the TSCA SACC during the in-person meeting to submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before January 14, 2019, in order to be included on the meeting agenda. Requests to present oral comments for the peer review will be accepted until the date of the in-person meeting and, to the extent that time permits, the Chair of the TSCA SACC may permit the presentation of oral comments at the in-person meeting by interested persons who have not previously requested time.
Requests to make oral comments at the in-person meeting 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 the 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 the comments and presentation for the DFO to distribute to the TSCA SACC at the meeting. The TSCA SACC will consider oral comments during their discussions.
2. Provide written comments. Follow the instructions in ADDRESSES and Unit I.B., to provide written comments on the draft risk evaluation.
3. Attend the meeting. Seating at the meeting will be open and on a first-come basis.
A. Purpose of the TSCA SACC
The Science Advisory Committee on Chemicals (SACC) was established by EPA in 2016 under the authority of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law 114-182, 140 Stat. 448 (2016), and operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2. The SACC supports activities under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., the Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes. The 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 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 SACC currently consists of 26 members. When needed, the committee will be assisted in their reviews by ad hoc participants with specific expertise in the topics under consideration.
B. In-Person Meeting
The focus of the TSCA SACC in-person meeting is to peer review the Agency's draft risk evaluation of C.I. Pigment Violet 29, which was developed under EPA's existing chemical substance process. C.I. Pigment Violet 29 is an organic pigment that has a low solubility, low volatility, is expected to be highly persistent, and has low bioaccumulation potential in fish and other animals. The pigment is utilized as an intermediate to create or adjust the color of other pigments, as well as in commercial paints, coatings, plastics, and rubber products.
Under TSCA, the purpose of the 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. EPA released the draft risk evaluation for C.I. Pigment Violet 29 for public review and comment on November 15, 2018 (83 FR 57473; FRL-9986-45), and is submitting the same materials to the TSCA SACC for peer review.
After the peer review process, EPA will consider reviewer comments and recommendations, and public comments, to finalize the risk evaluation.
Approximately one hour of the TSCA SACC's in-person meeting will be closed to the public for the TSCA SACC to consider and discuss material that has been claimed as CBI and provided to the Committee as background for the draft risk evaluation for PV29. In accordance with FACA section 10(d), and section (c)(4) of the Government in the Sunshine Act, 5 U.S.C. 552b, this approximately one-hour session of the TSCA SACC will be closed to the public to avoid the potential disclosure of CBI, which is protected from disclosure by statute. See the Administrator's determination for a closed meeting available in the docket identified by Docket ID No. EPA-HQ-OPPT-2018-0604 at http://www.regulations.gov.
C. TSCA SACC Documents and Meeting Minutes
EPA's background paper, related supporting materials, and draft charge/questions to the TSCA SACC are available on the TSCA SACC website and in docket. In addition, the Agency will provide additional background documents (e.g., a list of the SACC Members participating in this meeting and the meeting agenda) as those Start Printed Page 61631materials 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 and final report summarizing its recommendations to the Agency no later than 90 days after the meeting. The meeting minutes and final report will be posted on the TSCA SACC website and in the docket.
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Dated: November 21, 2018.
Stanley Barone, Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2018-26084 Filed 11-29-18; 8:45 am]
BILLING CODE 6560-50-P