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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: May 12, 2004 (Volume 69, Number 92)]
[Notices]
[Page 26379-26382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-41]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0146; FRL-7360-1]
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 product characterization, human health risk,
ecological risk, and insect resistance management (IRM) for Bacillus
thuringiensis (Bt) cotton products.
DATES: The meeting will be held on June 8 to June 10, 2004, from 8:30
a.m. to approximately 5 p.m, eastern daylight time.
Comments: For the deadlines for the submission of requests to
present oral comments and the submission of written comments, see Unit
I.E. 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 May 24, 2004.
Special seating: Requests for special seating arrangements should
be made at least 7 days prior to the meeting.
ADDRESSES: The meeting will be held at the Holiday Inn Arlington, 4610
North Fairfax Drive, Arlington, VA 22203. The telephone number for the
Holiday Inn Arlington is (703) 243-9800.
Comments: Written comments may be submitted electronically
(preferred), through hand delivery/courier, or by mail. Follow the
detailed instructions as provided in Unit I. of the SUPPLEMENTARY
INFORMATION.
Nominations, requests to present oral comments, and special
seating: To submit nominations for ad hoc members of the FIFRA SAP for
this meeting, requests for special seating arrangements, or requests to
present oral comments, notify the Designated Federal Official (DFO)
listed under FOR FURTHER INFORMATION CONTACT. To ensure proper receipt
by EPA, your request must identify docket ID number OPP-2004-0146 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
564-8450; fax number: 202-564-8382; e-mail addresses:
lewis.paul@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. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0146. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
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 as soon as possible, but no later than
late May 2004. 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 FIFRA SAP
Internet Home Page at http://www.epa.gov/scipoly/sap.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed
[[Page 26380]]
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments in hard copy that are mailed or delivered to
the docket will be scanned and placed in EPA's electronic public
docket. Where practical, physical objects will be photographed, and the
photograph will be placed in EPA's electronic public docket along with
a brief description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically (preferred), through hand
delivery/courier, or by mail. To ensure proper receipt by EPA, identify
the appropriate docket ID number in the subject line on the first page
of your comment. Please ensure that your comments are submitted within
the specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. Do not use EPA Dockets or e-mail to submit CBI or
information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0146. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID umber OPP-2004-0146. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you deliver as described in Unit I.C.2 or mail to the address
provided in Unit I.C.3. These electronic submissions will be accepted
in WordPerfect or ASCII file format. Avoid the use of special
characters and any form of encryption.
2. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2004-0146. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
3. By mail. Due to potential delays in EPA's receipt and processing
of mail, respondents are strongly encouraged to submit comments either
electronically or by hand delivery or courier. We cannot guarantee that
comments sent via mail will be received prior to the close of the
comment period. If mailed, please send your comments to: Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID
number OPP-2004-0146.
D. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. Provide specific examples to illustrate your concerns.
5. Make sure to submit your comments by the deadline in this document.
6. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
E. 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 OPP-2004-0146 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, interested persons may be
[[Page 26381]]
permitted by the Chair of FIFRA SAP to present oral comments at the
meeting. Each individual or group wishing to make brief oral comments
to FIFRA SAP is strongly advised to submit their request to the DFO
listed under FOR FURTHER INFORMATION CONTACT no later than noon,
eastern daylight time, June 2, 2004, 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
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 FIFRA SAP at the meeting.
2. Written comments. Although submission of 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 Unit I., no later than noon, eastern daylight time,
June 2, 2004, to provide FIFRA SAP the time necessary to consider and
review the written comments. There is no limit on the extent of written
comments for consideration by FIFRA SAP. Persons wishing to submit
written comments at the meeting should contact the DFO listed under FOR
FURTHER INFORMATION CONTACT and submit 30 copies.
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 and assistance for the hearing
impaired, should contact the DFO at least 7 days prior to the meeting
using the information under FOR FURTHER INFORMATION CONTACT so that
appropriate arrangements can be made.
4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. The FIFRA SAP staff routinely solicit the
stakeholder community for nominations to serve as ad hoc members of the
FIFRA SAP for each meeting. Any interested person or organization may
nominate qualified individuals to serve on the FIFRA SAP for a specific
meeting. No interested person 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). Individuals nominated should have expertise in
one or more of the following areas: Allelgenicity, acute toxicity,
product characterization, molecular characterization, ecological
toxicity, environmental fate, and exposure assessment. 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 May 24, 2004.
The criteria for selecting scientists to serve on the FIFRA SAP
are that these persons be recognized scientists--experts in their
fields; that they be as impartial and objective as possible; that they
represent an array of backgrounds and perspectives (within their
disciplines); have no financial conflict of interest; have not
previously been involved with the scientific peer review of the
issue(s) presented; and that they be available to participate fully in
the review, which will be conducted over a relatively short-time frame.
Nominees will be asked to attend the public meetings and to participate
in the discussion of key issues and assumptions at these meetings.
Finally, they will be asked to review and to help finalize the meeting
minutes.
If a FIFRA SAP nominee is considered to assist in a review by the
FIFRA SAP for a particular session, the nominee is subject to the
provisions of 5 CFR part 2634, Executive Branch Financial Disclosure,
as supplemented by the EPA in 5 CFR part 6401. As such, the FIFRA SAP
nominee is required to submit a Confidential Financial Disclosure Form
for Special Government Employees Serving on Federal Advisory Committees
at the U.S. Environmental Protection Agency (EPA Form 3110-485-02)
which shall fully disclose, among other financial interests, the
nominee's employment, stocks, and bonds, and where applicable, sources
of research support. The EPA will evaluate the nominee's financial
disclosure form to assess that there are no financial conflicts of
interest, the appearance of impartiality and should not have been
involved with the development of the documents under consideration
(including previous scientific peer review) before the nominee is
considered to serve on the FIFRA SAP. The Agency will review all
nominations with final selection of ad hoc members being a
discretionary function of the Agency. Selected FIFRA SAP members will
be hired as a Special Government Employee. FIFRA SAP members
participating at this meeting will be posted on the FIFRA SAP web site
or may be obtained by contacting the PIRIB at the address or telephone
number listed in Unit I. In order to have the collective breadth of
experience needed to address the Agency's charge, the Agency
anticipates greater than 10 ad hoc scientists will be selected for this
meeting.
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)(2) of FIFRA, as well as proposed and final forms of
rulemaking 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 for staggered terms of 4 years, based on
recommendations from 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 product
characterization, human health risk, ecological risk, and IRM for
Bacillus thuringiensis products. Dow AgroSciences has submitted an
application under section 3 of FIFRA, for full commercial use of their
cotton plant-incorporated protectant (PIP), Cry1F/Cry1Ac known as
WideStrike. This application was for a stacked PIP (one that contains
two or more proteins). Since this stacked PIP contains at least one
protein that has never been seen in cotton, it is
[[Page 26382]]
important to thoroughly assess the science. The Panel is asked to
review the following set of scientific issues being considered by the
Agency: Product characterization, human health risk, and ecological
risk for WideStrike cotton composed of (Bacillus thuringiensis var.
aizawai strain PS811 (Cry1F insecticidal protein in cotton and Bacillus
thuringiensis var. strain HD73 Cry1Ac insecticidal crystal protein in
cotton).
In September 2001, the Agency completed a reassessment of the PIP
Cry1Ac produced in cotton, known as BollGard cotton. At that time, the
Agency required the registrant, Monsanto Company, to submit data on
whether alternative host plants for the cotton bollworm assisted in
providing an adequate insect refuge to support an IRM plan allowing 95%
BollGard cotton and a 5% external, unsprayed structured non-Bt cotton
refuge. Data were also required on the use of chemical insecticides
being used on Bt cotton to increase the efficacy of the IRM plan for
cotton bollworm, and cotton bollworm reverse migration and its impact.
Since that time, the Agency has approved a second Bt cotton product
containing both Cry1Ac and Cry2Ab2. These same data requirements were
required for this application. This product, known as BollGard II, was
granted a full commercial use under section 3 of FIFRA on December 23,
2002. In addition, the Agency is now considering a third PIP for
cotton, WideStrike, which contains both Cry1Ac and Cry1F.
This meeting of the FIFRA SAP will also review the scientific
issues being considered by the Agency pertaining to IRM of the PIP
products BollGard, BollGard II, and WideStrike, including assessing the
Agency's review of several specific issues related to cotton bollworm
resistance management: (1) Utilization of alternate hosts as natural
refuge, (2) insecticidal overspray impacts, and (3) north-south reverse
migration. The Panel will be charged with assessing the Agency's
assessment of the aforementioned data submitted to support these
registrations and completing a report on the assessment. The Agency
will use the Panel's recommendations as it considers continuation of
the 5% external, unsprayed refuge option for cotton bollworm.
C. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 60 days after the
meeting. The meeting minutes will be posted on the FIFRA SAP web site
or may be obtained by contacting the PIRIB at the address or telephone
number listed in Unit I.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: May 3, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 04-10550 Filed 5-11-04; 8:45 am]
BILLING CODE 6560-50-S