[Federal Register Volume 78, Number 158 (Thursday, August 15, 2013)]
[Notices]
[Pages 49750-49752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19873]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0485; FRL-9393-3]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 1-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review RNAi Technology as a Pesticide: Problem Formulation 
for Human Health and Ecological Risk Assessment.

DATES: The meeting will be held on October 29, 2013, from 9 a.m. to 
approximately 6 p.m.
    Comments. The Agency encourages that written comments and requests 
for oral comments be submitted by October 21, 2013. However, written 
comments and requests to make oral comments may be submitted until the 
date of the meeting, but anyone submitting written comments after 
October 21, 2013 should contact the Designated Federal Official (DFO) 
listed under FOR FURTHER INFORMATION CONTACT. For additional 
instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before August 
29, 2013.
    Webcast. This meeting may be webcast. Please refer to the FIFRA 
SAP's Web site, http://www.epa.gov/scipoly/sap for information on how 
to access the webcast. Please note that the webcast is a supplementary 
public process provided only for convenience. If difficulties arise 
resulting in webcasting outages, the meeting will continue as planned.
    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: The meeting will be held at the Environmental Protection 
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments: Submit your comments, identified by docket ID number EPA-
HQ-OPP-2013-0485, 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.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.
    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.
    Nominations, requests to present oral comments, and requests for 
special accommodations. Submit nominations to serve as ad hoc members 
of FIFRA SAP, requests for special seating accommodations, or requests 
to present oral comments to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Sharlene Matten, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (202) 564-0130; fax number: (202) 564-8382; email 
address: [email protected].

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?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific 
questions or organize comments by referencing a Code of Federal 
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information 
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    6. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline 
identified.

 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-2013-0485 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be 
submitted, using the instructions in ADDRESSES, no later than October 
21, 2013, 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 
October 21, 2013 should contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT. Anyone submitting written comments at the meeting 
should bring 25 copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than October 22, 2013 in order to be included on the meeting 
agenda. Requests to present oral comments will be accepted until the 
date of the meeting and, to the extent that time permits, the

[[Page 49751]]

Chair of FIFRA SAP may permit the presentation of oral comments at the 
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 (e.g., overhead 
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP 
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 slides for distribution to the FIFRA SAP 
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and 
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP 
for this meeting. As part of a broader process for developing a pool of 
candidates for each meeting, FIFRA SAP staff routinely solicits the 
stakeholder community for nominations of prospective candidates for 
service as ad hoc members of FIFRA SAP. Any interested person or 
organization may nominate qualified individuals to be considered as 
prospective candidates for a specific meeting. Individuals nominated 
for this meeting should have expertise in one or more of the following 
areas:
     Ecological risk assessment
     Human health risk assessment
     Bioinformatics
     RNAi technology
     Biotechnology
     Plant breeding and genomics
    Nominees should be scientists who have sufficient professional 
qualifications, including training and experience, to be capable of 
providing expert comments on the scientific issues for this meeting. 
Nominees should be identified by name, occupation, position, address, 
and telephone number. Nominations should be provided to the DFO listed 
under FOR FURTHER INFORMATION CONTACT on or before August 29, 2013. The 
Agency will consider all nominations of prospective candidates for this 
meeting that are received on or before this date. However, final 
selection of ad hoc members for this meeting is a discretionary 
function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the 
function of the panel and the expertise needed to address the Agency's 
charge to the panel. No interested scientists shall be ineligible to 
serve by reason of their membership on any other advisory committee to 
a Federal department or agency or their employment by a Federal 
department or agency except the EPA. Other factors considered during 
the selection process include availability of the potential panel 
member to fully participate in the panel's reviews, absence of any 
conflicts of interest or appearance of lack of impartiality, 
independence with respect to the matters under review, and lack of 
bias. Although financial conflicts of interest, the appearance of lack 
of impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on FIFRA SAP. Numerous qualified 
candidates are identified for each panel. Therefore, selection 
decisions involve carefully weighing a number of factors including the 
candidates' areas of expertise and professional qualifications and 
achieving an overall balance of different scientific perspectives on 
the panel. In order to have the collective breadth of experience needed 
to address the Agency's charge for this meeting, the Agency anticipates 
selecting approximately 8-10 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634, 
Executive Branch Financial Disclosure, as supplemented by the EPA in 5 
CFR part 6401. In anticipation of this requirement, prospective 
candidates for service on the FIFRA SAP will be asked to submit 
confidential financial information which shall fully disclose, among 
other financial interests, the candidate's employment, stocks and 
bonds, and where applicable, sources of research support. The EPA will 
evaluate the candidates financial disclosure form to assess whether 
there are financial conflicts of interest, appearance of a lack of 
impartiality or any prior involvement with the development of the 
documents under consideration (including previous scientific peer 
review) before the candidate is considered further for service on FIFRA 
SAP. Those who are selected from the pool of prospective candidates 
will be asked to attend the public meetings and to participate in the 
discussion of key issues and assumptions at these meetings. In 
addition, they will be asked to review and to help finalize the meeting 
minutes. The list of FIFRA SAP members participating at this meeting 
will be posted on the FIFRA SAP Web site at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket or at http://www.regulations.gov.

II. Background

A. Purpose of FIFRA SAP

    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 under FIFRA that operates in accordance with requirements of the 
Federal Advisory Committee Act. 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. FIFRA established a Science 
Review Board consisting of at least 60 scientists who are available to 
the SAP on an ad hoc basis to assist in reviews conducted by the SAP. 
As a peer review mechanism, 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

    The use of RNA Interference (RNAi) gene silencing technology, 
particularly RNAi gene silencing for pesticidal purposes, is a 
relatively recent innovation. Post-transcriptional silencing of gene 
function is a very rapid process where double-stranded RNA (dsRNA) 
directs sequence-specific degradation of an RNA. The EPA is beginning 
to receive applications for regulatory actions on pesticides based on 
RNAi gene silencing technologies. The EPA recognizes the need to better 
understand the scientific issues concerning the assessment of the risks 
to human health and the environment that RNAi technologies may pose 
before any regulatory decisions concerning these products can be made. 
In 1998, the U.S. Environmental Protection Agency developed a 
formalized process for risk assessment. Problem formulation is the 
first step in this process. In problem formulation, available 
information is used to define assessment endpoints and to develop a 
preliminary understanding of potential risks (i.e., develop a risk 
hypothesis and conceptual model) associated with the use of a 
pesticide. Problem formulation also serves as an opportunity to 
identify missing information/uncertainties that may limit the 
assessment and any assumptions that may be made in the absence of such 
data. The EPA is

[[Page 49752]]

seeking the input of the FIFRA SAP on the assessment of pesticide 
products based on RNAi technology, particularly with regard to general 
uncertainties in the current state of knowledge about dsRNAs, including 
the potential fate of dsRNAs genetically-engineered into plants or 
other organisms in the environment and any avenues through which they 
may present risk to human health and/or the environment.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc 
members for this meeting), and the meeting agenda will be available by 
early October. In addition, the Agency may provide additional 
background documents as the materials become available. You may obtain 
electronic copies of these documents, and certain other related 
documents that might be available electronically, at http://www.regulations.gov and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
    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 Web site or may be 
obtained from the OPP Docket or at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 29, 2013.
David J. Dix,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2013-19873 Filed 8-14-13; 8:45 am]
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