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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[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]
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