
[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Notices]               
[Page 75099-75101]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de08-49]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0836; FRL-8392-7]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review a set of scientific issues being considered by the 
Agency pertaining an Evaluation of the Resistance Risks from Using a 
Seed Mix Refuge with Pioneer's Optimum[reg] 
AcreMaxTM 1 Corn Rootworm-Protected Corn.

DATES: The meeting will be held on Monday February 23, 2009 from 1:30 
p.m. to 5 p.m.; and on Wednesday, February 25, 2009 from 8:30 a.m. to 
12 noon (eastern time).
    Comments. The Agency encourages that written comments be submitted 
by February 9, 2009 and requests for oral comments be submitted by 
February 16, 2009. However, written comments and requests to make oral 
comments may be submitted until the date of the meeting, but anyone 
submitting written comments after February 9, 2009 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 the FIFRA SAP for this meeting should be provided on or before 
December 24, 2008.
    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-2008-0836, 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-
2008-0836. 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 website 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 the 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: Joseph E. Bailey, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail 
addresses: bailey.joseph@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.

[[Page 75100]]

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-2008-0836; 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 February 
9, 2008, to provide the 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 
February 9, 2008 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.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to the FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than February 16, 2008, 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 
the 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 the 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 the FIFRA 
SAP for this meeting. As part of a broader process for developing a 
pool of candidates for each meeting, the FIFRA SAP staff routinely 
solicits the stakeholder community for nominations of prospective 
candidates for service as ad hoc members of the 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: Insect population genetics, corn rootworm 
biology and population dynamics, simulation modeling for pest 
resistance in Bt agricultural systems (preferably maize), and 
statistical analysis. 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 December 
24, 2008. 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 the 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 the 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 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 the 
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 website 
at http://epa.gov/scipoly/sap or may be obtained from the OPP 
Regulatory Public Docket at http://www.regulations.gov.

[[Page 75101]]

 II. Background

 A. Purpose of the FIFRA SAP

    The FIFRA SAP serves as the primary scientific peer review 
mechanism of EPA's Office of Prevention, Pesticides and Toxic 
Substances (OPPTS) 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. 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. 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 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 
Scientific Advisory Panel on an ad hoc basis to assist in reviews 
conducted by the Scientific Advisory Panel. As a 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 the 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's Office of Pesticide Programs (OPP) has received an 
application of registration from Pioneer Hi-Bred International, Inc. 
for registration of Optimum[reg] AcreMaxTM 1 
Insect Protection, which is a corn seed blend containing seeds that 
express the Bt toxins Cry34Ab1, Cry35Ab1, and Cry1F in a stack for corn 
rootworm (CRW) and lepidopteran protection mixed with seeds that 
express only Cry1F for lepidopteran protection (i.e. ``refuge in the 
bag'' for CRW). Pioneer proposes to use a seed blend mixture containing 
>= 2% refuge seeds. OPP has reviewed the submitted studies and modeling 
chapter and has identified several areas of uncertainties with respect 
to CRW biology, population genetics, and modeling. EPA is seeking the 
assistance of the FIFRA SAP to address the scientific issues associated 
with the seed mix proposal for CRW resistance management and provide 
the Agency with guidance as to the implications of the uncertainties. 
These areas of uncertainties include:
    1. Mode of action of Cry34/35Ab1 (i.e. toxic or repellent) to 
exposed CRW and implications for a seed mix,
    2. Aspects of corn rootworm pest biology including the effects of 
delayed emergence and uneven sex ratios on random mating and ultimately 
on the rate of resistance evolution in a seed blend environment;
    3. Assumptions about initial resistance gene frequency to Cry34/
35Ab1;
    4. Contributions of tolerance (minor) and resistance (major) genes 
and selection consequences in corn rootworm exposed to Cry34/35Ab1 in a 
seed blend environment;
    5. Mortality for individuals being heterozygous (XY) and 
susceptible (XX) for the tolerance (minor) gene;
    6. The overall simulation model (i.e. is it adequate to evaluate 
the proposed seed mix for Cry34/35Ab1); and
    7. The mechanics of mixing refuge seed with Cry34/35Ab1 seed into a 
single bag and the potential distribution (i.e. random or non-random) 
of refuge plants within planted fields.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to the FIFRA SAP, FIFRA SAP composition i.e., members and ad 
hoc members for this meeting, and the meeting agenda will be available 
by late January, 2009. 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.
    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 or may be 
obtained from the OPP Regulatory Public Docket at http://
www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 2, 2008.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. E8-29114 Filed 12-9-08; 8:45 am]

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