2017-20430. FIFRA Scientific Advisory Panel; Notice of Public Meeting for the Clarification of Charge Questions on PBPK

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a three-hour meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to review and consider the scope and clarity of the draft charge questions for the October 24-27, 2017 SAP Meeting on physiologically-based pharmacokinetic (PBPK) modeling to address pharmacokinetic differences between and within species.

DATES:

The meeting will be held on October 2, 2017, from approximately 2 p.m. to 5 p.m. (EST). This is an open public meeting that will be conducted via webcast using Adobe Connect and telephone. Registration is required to attend this meeting. Please visit: http://www.epa.gov/​sap to register.

Comments. Written comments on the scope and clarity of the draft charge questions should be submitted by noon on September 27, 2017. FIFRA SAP may not be able to fully consider written comments submitted after noon on September 27, 2017. Requests to make oral comments at the meeting should be submitted on or before noon on September 27, 2017 by registering at http://www.epa.gov/​sap. For additional instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION or contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.

Webcast. This meeting will be webcast only. Please refer to the FIFRA SAP Web site at http://www.epa.gov/​sap for information on how to access the webcast.

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 allow EPA time to process your request.

ADDRESSES:

Meeting: This meeting will be webcast only. Please refer to the following Web site to register and for information on how to access the webcast: http://www.epa.gov/​sap.

Comments. Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0180, 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: OPP 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 for special accommodations. Submit requests for special accommodations to the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Dr. Marquea D. King, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 202-564-3626; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, 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 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.

C. How may I participate in this meeting?

You may participate in this 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-OPP-2017-0180 in the subject line on the first page of your request.

1. Written comments. Written comments should be submitted, using the instructions in ADDRESSES and Unit I.B., on or before noon on September 27, 2017, to provide FIFRA SAP the time necessary to consider and review the written comments. FIFRA SAP may not be able to fully consider written comments submitted after noon on September 27, 2017.

2. Oral comments. Registration is required to attend this meeting. Please visit: http://www.epag.gov/​sap to register. Each individual or group wishing to make brief oral comments to FIFRA SAP may submit their request by registering on or before noon September 27, 2017. Oral comments before FIFRA SAP are limited to approximately 5 minutes due to the time constraints of this webcast.

II. Background

A. Purpose of FIFRA SAP Virtual Meeting on PBPK Charge Questions

FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 pursuant to FIFRA and operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. The FIFRA SAP is assisted in their reviews by ad hoc participation from the Science Review Board (SRB). As a scientific peer review mechanism, FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. The FIFRA SAP strives to reach consensus however, is not required to reach consensus in its recommendations to the Agency.

B. Public Meeting

During the meeting scheduled for October 2, 2017, the FIFRA SAP will review and consider the Charge Questions for the Panel's October 24-27, 2017 Meeting on Physiologically Based Pharmacokinetic (PBPK) Modeling. The SAP will receive a short background briefing including the EPA's history and current position on the use of PBPK modeling. In addition, the panel members will have the opportunity to comment on the scope and clarity of the draft charge questions. Subsequent to this meeting, final charge questions will be provided for the FIFRA SAP's deliberation on the white papers and supplemental information during the in-person meeting to be held on October 24-27, 2017.

C. FIFRA SAP Documents and Meeting Minutes

EPA's background documents, charge questions to the FIFRA SAP, and the meeting agenda will be available before or on September 13, 2017. In addition, the Agency may provide additional background documents as additional materials become available. You may obtain electronic copies of most meeting documents, including FIFRA SAP composition (i.e., members and ad hoc members for this meeting) and the meeting agenda, at http://www.regulations.gov and the FIFRA SAP Web site at http://www.epa.gov/​sap.

FIFRA SAP will prepare meeting minutes approximately 90 calendar days after the meeting. The meeting minutes will be posted on the FIFRA SAP Web site: http://www.epa.gov/​sap and may be accessed in the docket at http://www.regulations.gov.

Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

Dated: September 11, 2017.

Inza Graves,

Acting, Director, Office of Science Coordination and Policy.