2019-07418. FIFRA Scientific Advisory Panel; Notice of Public Meetings

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 4-day, in-person public meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), augmented with additional experts to provide independent scientific advice to the EPA on proposed guidelines for Efficacy Testing of Topically Applied Pesticides Used Against Certain Ectoparasitic Pests on Pets. Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review.

DATES:

Meeting: The 4-day in-person public meeting will be held June 11 to 14, 2019, from 9:00 a.m. to approximately 5:00 p.m. (EDT). The date, time, and registration instructions for the preparatory virtual public meeting will be announced on the FIFRA SAP website (http://www.epa.gov/​sap) by late-April. You may also subscribe to the following listserv for alerts when notices regarding this and other SAP-related activities are published: https://public.govdelivery.com/​accounts/​USAEPAOPPT/​subscriber/​new?​topic_​id=​USAEPAOPPT_​101.

Comments: The Agency encourages written comments and requests for oral comments be submitted on or before May 17, 2019. However, written comments and requests to make oral comments may be submitted until the date of the in-person meeting, but anyone submitting such comments and requests after May 17, 2019, should contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C. and Unit I.D. of the SUPPLEMENTARY INFORMATION.

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.

ADDRESSES:

 

In-Person Meeting: This public meeting will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA 22202. This meeting may also be viewed via webcast. Please refer to the FIFRA SAP website at https://www.epa.gov/​sap for information on how to access the webcasts. Please note that this 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.

Webcast: The preparatory virtual meeting is open to the public and will be conducted via webcast using Adobe Connect and telephone. Registration is required to participate during the preparatory virtual meeting. Please refer to the FIFRA SAP website at https://www.epa.gov/​sap for additional information including how to register.

Requests to present oral comments and requests for special accommodations. Submit such requests to the DFO listed under FOR FURTHER INFORMATION CONTACT.

Comments. Submit your comments, identified as docket identification (ID) number EPA-HQ-OPP-2019-0161, 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 that 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.

FOR FURTHER INFORMATION CONTACT:

Dr. Suhair Shallal, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-2057; 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 be of interest to persons who are or may be required to conduct testing of chemical substances regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested in this guidance, 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 the website regulations.gov or by 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 Tips for Effective Comments at http://www.epa.gov/​dockets/​comments.html.

C. 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 docket ID number EPA-HQ-OPP-2019-0161 in the subject line on the first page of your request.

1. Written comments. The Agency encourages written comments be submitted, using the instructions in ADDRESSES and Unit I.B., on or before May 17, 2019, to provide FIFRA SAP the time necessary to consider and review the written comments. Written comments are accepted until the date of the meeting, but anyone submitting written comments after May 17, 2019, should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone submitting written comments at the meeting should bring 30 copies for distribution to the FIFRA SAP by the DFO.

2. Oral comments. The Agency encourages each individual or group wishing to make brief oral comments to the FIFRA SAP during the in-person meeting to submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before May 17, 2019, in order to be included on the meeting agenda. Requests to present oral comments will be accepted until the date of the in-person meeting and, to the extent that time permits, the Chair of the FIFRA SAP may permit the presentation of oral comments at the in-person meeting by interested persons who have not previously requested time. 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 the FIFRA SAP during the in-person meeting are limited to approximately 5 minutes unless arrangements have been made prior to May 17, 2019. In addition, each speaker should bring 30 copies of his or her comments and presentation for distribution to the FIFRA SAP during the meeting by the DFO.

3. Seating at the meeting. Seating at the meeting will be open and on a first-come basis.

D. How may I participate in the preparatory virtual meeting?

Registration for the preparatory virtual meeting is required. To participate by listening or making a comment during this meeting, please visit: https://www.epa.gov/​sap to register. Registration online will be confirmed by email that will include the webcast meeting Adobe Connect link and audio teleconference information.

1. Written comments. Written comments for the preparatory virtual meeting should be submitted, using the instructions in ADDRESSES and Unit I.B., on or before May 17, 2019.

2. Oral comments. Registration is required to participate in the preparatory virtual meeting. Please visit the FIFRA SAP website at: https://www.epa.gov/​sap to register online. Each individual or group wishing to make brief oral comments to the FIFRA SAP during the preparatory virtual meeting should submit their request when registering online or with the DFO listed under FOR FURTHER INFORMATION CONTACT on or before noon May 17, 2019. Oral comments before the FIFRA SAP during the preparatory webcast are limited to approximately 5 minutes due to the time constraints of this webcast.

3. Webcast. The preparatory meeting will be webcast only. Please refer to the FIFRA SAP website at https://www.epa.gov/​sap for information on how to access the webcast. Registration is required.

II. Background

A. Purpose of the FIFRA SAP

The FIFRA SAP serves as one of the primary scientific peer review mechanisms of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. The FIFRA SAP is a federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). The 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 (NIH) and the National Science Foundation (NSF). FIFRA established a Science Review Board (SRB) consisting of at least 60 scientists who are available to FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. As a scientific peer review mechanism, the FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.

B. Public Meeting

EPA-registered pesticide products are an important part of pest management programs to control invertebrate pests of public health importance including fleas, ticks, mosquitoes, and biting flies that can vector diseases to pets and humans. The Agency has multiple guidelines intended to assist in the development of appropriate protocols to test product efficacy. EPA Product Performance Test Guideline OPPTS 810.3300 Treatments to Control Pests of Humans and Pets published in March 1998. To increase clarity and consistency in efficacy testing and to include current scientific standards, the Agency is revising this product performance guideline.

The proposed guideline applies to products in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies. This guideline does not apply to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other Agency guidelines. In addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline also includes testing methods for evaluating efficacy under simulated environmental conditions. The Agency is seeking advice and recommendations from the SAP on scientific issues associated with the proposed revised EPA guideline. The Agency believes the current draft guideline represents the state of the science with regard to efficacy testing for these products. EPA is committed to reducing the use of animals in testing (https://www.regulations.gov/​document?​D=​EPA-HQ-OPP-2016-0093-0003). However, at this time no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes and biting flies. As part of the SAP, EPA is soliciting comment from the panel on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.

C. FIFRA SAP Documents and Meeting Minutes

The EPA's background paper, the supporting materials, and draft charge/questions to the FIFRA SAP will be available by mid-April 2019. In addition, a list of candidates under consideration as prospective ad hoc panelists for this meeting will be available for a 15-day public comment period by early to mid-April 2019. The Agency will provide additional background documents (e.g., 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 in docket EPA-HQ-OPP-2019-0161 and on the FIFRA SAP website at https://www.epa.gov/​sap.

The FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP website at https://www.epa.gov/​sap or may be obtained from the OPP Docket at http://www.regulations.gov.

Authority: 5 U.S.C Appendix 2 et seq.; 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

Dated: April 9, 2019.

Hayley Hughes,

Director, Office of Science Coordination and Policy.