[Federal Register Volume 69, Number 92 (Wednesday, May 12, 2004)]
[Notices]
[Pages 26379-26382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10550]


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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: 
[email protected].

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.epa.gov/edocket/ 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

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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 [email protected], 
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

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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