

[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Notices]               
[Page 43737-43740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au06-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0657; FRL-8083-5]

 
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 
review the evaluation of the resistance risks from using 100% Bollgard 
and Bollgard II cotton as part of a pink bollworm eradication program 
in the state of Arizona.

DATES: The meeting will be held on October 24-26, 2006, from 8:30 a.m. 
to approximately 5 p.m., eastern time.
    Comments: For the deadlines for the submission of requests to 
present oral comments and submission of written comments, see Unit I.C. 
of the SUPPLEMENTARY INFORMATION.
    Nominations: Nominations of scientific experts to serve as ad hoc 
members of the FIFRA SAP for this meeting should be provided on or 
before August 23, 2006.
    Special accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT at least 10 business 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 Holiday Inn Rosslyn Hotel, 
1900 North Fort Myer Dr., Arlington, VA 22209. The telephone number for 
the Holiday Inn Rosslyn Hotel is (703) 807-2000.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0657, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line 

instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P),

[[Page 43738]]

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'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 telephone number is 
(703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0657. EPA's policy is that all comments received will be included 
in the public 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 captured automatically and included as part 
of the comment that is placed in the public 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. 
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 Drive, 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 telephone number is (703) 305-
5805.
    Nominations, requests to present oral comments, and special 
accommodations: See Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Myrta R. Christian, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (202) 564-8498; fax number: (202) 564-8382; e-mail addresses: 
christian.myrta@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 preparing and submitting comments, remember to use these tips:
    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-2006-0657 in the subject line 
on the first page of your request.
    1. Oral comments. Oral comments presented at the meetings should 
not be repetitive of previously submitted oral or written comments. 
Although requests to present oral comments are accepted until the date 
of the meeting (unless otherwise stated), 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. However, each individual or group wishing to make brief 
oral comments to the FIFRA SAP is strongly advised to submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than noon, eastern time, October 17, 2006, in order to be 
included on the meeting agenda. 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.
    2. Written comments. Although written comments are accepted until 
the date of the meeting (unless otherwise stated), the Agency 
encourages that written comments be submitted, using the instructions 
in ADDRESSES, no later than noon, eastern time, October 10, 2006, to 
provide the FIFRA SAP the time necessary to consider and review the 
written comments. It is requested that persons submitting comments 
directly to the docket also notify the DFO listed under FOR FURTHER 
INFORMATION CONTACT. Persons wishing to submit written comments at the 
meeting should bring 30 copies. There is no limit on the extent of 
written

[[Page 43739]]

comments for consideration by the FIFRA SAP.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis. Individuals requiring special accommodations at this 
meeting, including wheelchair access, should contact the DFO at least 
10 business days prior to the meeting using the information under FOR 
FURTHER INFORMATION CONTACT so that appropriate arrangements can be 
made.
    4. Request for nominations of prospective candidates for service 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 solicit 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 the meeting announced in this notice 
should have expertise in one or more of the following areas:
     Familiarity with western cotton production,
     Knowledge of pink bollworm biology,
     Knowledge of insect resistance management for Bt cotton 
(principles and applications),
     Knowledge of pink bollworm eradication programs in western 
cotton,
     Knowledge of population dynamics modeling. Sterile Insect 
Technology (SIT),
     Resistance modeling,
     Knowledge of statics.
    Nominees should be scientists who have sufficient professional 
qualifications, including training and experience, to be capable of 
providing expert comments on the 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 14, 2006. 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 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. Though 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.
    If a prospective candidate for service on the FIFRA SAP is 
considered for participation in a particular session, the candidate is 
subject to the provisions of 5 CFR part 2634, Executive Branch 
Financial Disclosure, as supplemented by EPA in 5 CFR part 6401. As 
such, the FIFRA SAP candidate is required to submit a Confidential 
Financial Disclosure Form for Special Government Employees Serving on 
Federal Advisory Committees at the Environmental Protection Agency (EPA 
Form 3110-48 5-02) 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 
candidate's financial disclosure form to assess that there are no 
financial conflicts of interest, no appearance of lack of impartiality, 
and no 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 or may be obtained by 
contacting the OPP Regulatory Public Docket at the address or telephone 
number listed under ADDRESSES.

II. Background

A. Purpose of the FIFRA SAP

    Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)), 
include a requirement under section 25(d) of FIFRA that notices of 
intent to cancel or reclassify pesticide regulations pursuant to 
section 6(b) of FIFRA, as well as proposed and final forms of 
regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP 
prior to being made public or issued to a registrant. In accordance 
with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to 
comment on the health and environmental impact of such actions. The 
FIFRA SAP also shall make comments, evaluations, and recommendations 
for operating guidelines to improve the effectiveness and quality of 
analyses made by Agency scientists. Members are scientists who have 
sufficient professional qualifications, including training and 
experience, to be capable of providing expert comments as to the impact 
on health and the environment of regulatory actions under sections 6(b) 
and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals 
to serve on the FIFRA SAP from nominations provided by the National 
Institutes of Health and the National Science Foundation.
    Section 104 of FQPA (Public Law 104-170) established the FQPA 
Science Review Board (SRB). These scientists shall be available to the 
FIFRA SAP on an ad hoc basis to assist in reviews conducted by the 
FIFRA SAP.

B. Public Meeting

    The FIFRA SAP will meet to consider and review the evaluation of 
the resistance risks from using 100% Bollgard and Bollgard II cotton as 
part of a pink bollworm eradication program in the state of Arizona. 
The State of Arizona issued two special local need registrations under 
FIFRA section 24(c) in March 2006 permitting the use of 100% 
Bollgard[reg] and Bollgard II[reg] cotton varieties along with sterile 
pink bollworm moths (i.e., sterile insect technology or SIT), 
pheromones, and limited use of chemical insecticides in a sanctioned 
pink bollworm (PBW) eradication program. As a provision of these 
registrations, the State of Arizona agreed to provide the Agency with 
data to support the continued use of the FIFRA 24(c) registrations. 
These data will focus on addressing the uncertainties associated with 
the

[[Page 43740]]

expected effectiveness of the PBW eradication program using sterile 
insect technology, 100% Bollgard and Bollgard II cotton, pheromones, 
and limited insecticide use. The Agency is concerned with the potential 
increased insect resistance that may be posed by the use of 100% 
Bollgard and Bollgard II cotton (i.e., no structured non-Bt cotton 
refuge, very high selection intensity) and whether the SIT can be used 
effectively to manage PBW resistance should it occur during the 4-year 
eradication program. The State of Arizona, in consultation with USDA 
and University experts, devised a plan that replaces the biological 
function served by non-Bt cotton refuges with artificially raised 
sterile pink bollworm moths. The Panel will be asked to comment on the 
Agency's review of the effectiveness of this plan using field level 
systematic monitoring and mapping data in conjunction with modeling 
simulations.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP 
composition (i.e., members and consultants for this meeting), and the 
meeting agenda will be available by the end of September 2006. 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, from the regulations.gov website 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 in approximately 90 days after the 
meeting. The meeting minutes will be posted on the FIFRA SAP website or 
may be obtained by contacting the OPP Regulatory Public Docket at the 
address or telephone number listed under ADDRESSES.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 27, 2006.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-12435 Filed 8-1-06; 8:45 am]

BILLING CODE 6560-50-S
