
[Federal Register: October 27, 2010 (Volume 75, Number 207)]
[Notices]               
[Page 66089-66092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc10-61]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0772; FRL-8848-2]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: There will be a 2-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review scientific issues associated with Insect Resistance 
Management for SmartStaxTM Refuge-in-the-Bag, a Plant-
Incorporated Protectant (PIP) Corn Seed Blend.

DATES: The meeting will be held on December 8-9, 2010, from 9 a.m. to 
approximately 5:30 p.m.
    Comments. The Agency encourages that written comments be submitted 
by November 29, 2010, and requests for oral comments be submitted by 
December 3, 2010. However, written comments and requests to make oral 
comments may be submitted until the date of the meeting, but anyone 
submitting written comments after November 29, 2010, 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 November 
12, 2010.
    Webcast. This meeting may be webcast. Please refer to the FIFRA 
SAP's Web site, http://www.epa.gov/scipoly/

[[Page 66090]]

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 identification 
(ID) number EPA-HQ-OPP-2010-0772, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2010-0772. 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. EPA's policy is that all comments received 
will be included in the docket without change and may be made available 
on-line at http://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through 
regulations.gov or e-mail. The regulations.gov Web site is an 
``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the docket and made available on the Internet. If you submit 
an electronic comment, EPA recommends that you include your name and 
other contact information in the body of your comment and with any disk 
or CD-ROM you submit. If EPA cannot read your comment due to technical 
difficulties and cannot contact you for clarification, EPA may not be 
able to consider your comment. Electronic files should avoid the use of 
special characters, any form of encryption, and be free of any defects 
or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.
    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; e-mail 
address: matten.sharlene@epa.gov.

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), FIFRA, and the Food Quality Protection Act of 
1996 (FQPA). 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. If you have any questions regarding the 
applicability of this action to a particular entity, consult the DFO 
listed under FOR FURTHER INFORMATION CONTACT.

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-2010-0772 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 November 
29, 2010, to provide FIFRA SAP the time necessary to consider and 
review the written comments. Written comments

[[Page 66091]]

are accepted until the date of the meeting, but anyone submitting 
written comments after November 29, 2010, should contact the DFO listed 
under FOR FURTHER INFORMATION CONTACT. Anyone submitting written 
comments at the meeting should bring 30 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 December 3, 2010, 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 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: Corn pest entomology (biology and ecology), population genetics, 
insect resistance to pesticides, simulation modeling.
    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 November 12, 2010. 
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 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 10-12 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634, 
Executive Branch Financial Disclosure, as supplemented by 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. 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://epa.gov/scipoly/sap or may be obtained 
from the OPP Regulatory Public Docket 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, as amended by FQPA, 
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 Agency is currently evaluating the SmartStaxTM 
Refuge-in-the-Bag (RIB) product, a multi-trait plant-incorporated 
protectant (PIP) corn seed blend consisting of a mixture of 95% 
Bacillus thuringiensis (Bt) corn seed and 5% refuge corn seed for 
insect resistance management (IRM) of European corn borer (ECB), other 
lepidopteran corn pests, and corn rootworm. SmartStaxTM RIB 
was developed jointly by the Monsanto Company and Dow AgroSciences, 
LLC. The focus of this FIFRA SAP will be on the SmartStaxTM 
RIB IRM concept for ECB and other lepidopteran corn pests rather than 
on the rootworm. IRM considerations

[[Page 66092]]

associated with a Bt PIP corn seed blend targeting rootworm (a Pioneer 
Hi-Bred International, Inc. product) were previously addressed in the 
February 2009 FIFRA SAP meeting (http://www.epa.gov/scipoly/sap/
meetings/2009/february/232009finalreport.pdf).
    During a February 1998 FIFRA SAP meeting (see http://www.epa.gov/
scipoly/sap/meetings/1998/february/finalfeb.pdf), the Panel concluded 
that seed mixes should not be considered as a viable IRM refuge option 
for ECB and corn earworm in Bt corn. The concern was that ECB larvae 
can move from plant to plant within corn fields (including from refuge 
plants to Bt plants and vice-versa) which could reduce the 
effectiveness of the seed blend at preventing pest resistance. 
Subsequent to the 1998 SAP, new biological data and simulation modeling 
were developed to support the potential use of a seed blend IRM 
strategy in Bt corn. EPA's Office of Pesticide Programs has considered 
these data and has utilized the Office of Research and Development 
(ORD) POPGEN model to evaluate the risk of ECB resistance developing in 
a seed blend environment. The Agency is requesting the FIFRA SAP to 
address scientific issues associated with the SmartStaxTM 
RIB IRM strategy relative to the effectiveness of block refuges 
currently required for lepidopteran pests of Bt corn.

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 
late November 2010. 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 Regulatory Public Docket at http://
www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: October 7, 2010.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-26722 Filed 10-26-10; 8:45 am]
BILLING CODE 6560-50-P

