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Bt corn for rootworm comment period open until 8-27 (Aug. 7, 2002 -- CropChoice news) -- The FR notice below announces EPA's intention to hold a three-day public
Scientific Advisory Panel meeting August 27-29 to obtain advice from
scientists on issues related to Monsanto's request to register Bt corn
engineered to protect against corn rootworm (CRW). EPA has prepared several
documents assessing the risks of the CRW Bt corn. Those papers, which are
available at the EPA SAP website
http://www.epa.gov/scipoly/sap/index.htm#August will be central to the SAP
deliberations.
This meeting is likely to be the public's last opportunity to comment on
Monsanto's request to register this Bt corn. EPA will accept comments from
the public until August 29.
In late May, 2002, UCS, along with Environmental Defense, submitted comments
to EPA on Monsanto's CRW Bt corn application. Those comments are available at
http://www.biotech-info.net/Cry3Bb-5-02final.pdf.
[Federal Register: July 24, 2002 (Volume 67, Number 142)]
ENVIRONMENTAL PROTECTION AGENCY
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: There will be a meeting of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) Scientific Advisory Panel (FIFRA SAP) to
consider and review corn rootworm plant-incorporated protectant insect
resistance management and non-target insect issues.
DATES: The meeting will be held on August 27-29, 2002, from 8:30 a.m.
to 5 p.m, eastern standard time.
For dates on requests to present oral comments, submission of
written comments, or requests for special seating arrangements, see
Unit I.C. of the SUPPLEMENTARY INFORMATION.
For requests for nominations to serve as Ad-Hoc members of the
FIFRA SAP for this meeting, see Unit II.C. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES: The meeting will be held at Sheraton Crystal City Hotel,
1800 Jefferson Davis Hwy., Arlington, VA. The telephone number for the
Sheraton Crystal City Hotel is (703) 486-1111.
Requests to present oral comments, submission of written comments,
or requests for special seating arrangements may be submitted by mail,
electronically, or in person. Please follow the detailed instructions
for each method as provided in Unit I. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your request must
identify docket ID number OPP-2002-0157 in the subject line on the
first page of your response.
Send nominations to serve Ad-Hoc members of the FIFRA SAP for this
meeting to 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-2002-0157 in the subject
line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Paul Lewis, DFO, Office of Science
Coordination and Policy (7202M), 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:
[[Page 48462]]
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 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 Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at: http://www.epa.gov/fedrgstr/.
A meeting agenda relevant to this meeting is now available. EPA's
position paper, questions to FIFRA SAP, and FIFRA SAP composition
(i.e., members and consultants) will be available as soon as possible,
but no later than early August. 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.
2. In person. The Agency has established an official record for
this meeting under docket ID number OPP-2002-0157. The official record
consists of the documents specifically referenced in this notice, any
public comments received during an applicable comment period, and other
material information, including any information claimed as Confidential
Business Information (CBI). This official record includes the documents
that are physically located in the docket, as well as the documents
that are referenced in those documents.
The public version of the official record, which includes printed,
paper versions of any electronic comments that may be submitted during
an applicable comment period, is available for inspection in the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
C. How May I Participate in this Meeting?
You may submit requests to present oral comments, written
comments, or requests for special seating arrangements through the
mail, in person, or electronically. Do not submit any information in
your request that is considered CBI. To ensure proper receipt by EPA,
it is imperative that you identify docket ID number OPP-2002-0157 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 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 standard time, August 22, 2002, 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, the speaker should bring to the meeting 30 copies of the oral
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 no later than
noon, eastern standard time, August 22, 2002, 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, should contact the DFO at least 5
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT so that appropriate arrangements can be
made.
4. Submission of requests and written comments--a. By mail. Submit
your request or written comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Pennsylvania Ave., NW., Washington, DC 20460.
b. In person or by courier. Deliver your request or written
comments to: Public Information and Records Integrity Branch (PIRIB),
Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The
PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
c. Electronically. You may submit your request or written comments
electronically by e-mail to: opp-docket@epa.gov. Do not submit any
information electronically that you consider to be CBI. Use WordPerfect
9.0 or ASCII file format and avoid the use of special characters and
any form of encryption. Be sure to identify by docket ID number OPP-
2002-0157. You may also file a request online at many Federal
Depository Libraries.
II. Background
A. Purpose of the FIFRA Scientific Advisory Panel
Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d)),
include a requirement under section 25(d) that notices of intent to
cancel or reclassify pesticide regulations pursuant to section 6(b)(2),
as well as proposed and final forms of rulemaking pursuant to section
25(a), be submitted to a Scientific Advisory Panel (SAP) prior to being
made public or issued to a registrant. In accordance with FIFRA section
25(d), the SAP is to have an opportunity to comment on the health and
environmental impact of such actions. The Panel 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 Panel for staggered terms of 4 years, based on recommendations from
the National Institute of Health and the National Science Foundation.
Section 104 of the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170 established the FQPA Science Review Board (SRB).
These scientists shall be available to the SAP on an ad hoc basis to
assist in reviews conducted by the Panel.
B. Purpose of the Meeting
The FIFRA SAP will meet to consider and review corn rootworm
plant-incorporated protectant insect resistance management and non-
target insect issues. Monsanto Company has requested a registration for
the plant-incorporated protectant Bacillus thuringiensis Cry3Bb1
protein and the genetic material (ZMIR13L) necessary for its production
in corn. The Cry3Bb1 protein is intended to control corn rootworms
(CRW, Diabrotica spp.), a coleopteran pest of corn. This registration
application is limited to event MON 863 corn and descendant lines and
varieties. Studies were submitted to support registration of the
transformation event MON 863. CRW, a primary pest of corn in the United
States, feeds on corn roots as larvae leading to a reduction in the
plant's ability to absorb water and nutrients from soil and lodging. In
areas where CRW is a pest (e.g., Corn Belt), significant financial
losses are realized from a decrease in production and the cost of
chemical insecticides used to control this insect pest. Significant
acres of corn are treated annually to control CRW with organophosphate,
carbamate and pyrethroid insecticides.
Monsanto has conducted experiments using Cry3Bb1 corn for the last
3 years (2000-2002) under Experimental Use Permits. This has allowed
for data to be developed to support the company's application for a
commercial registration under FIFRA. EPA has conducted a risk
assessment based on the data submitted. The Agency is seeking the FIFRA
SAP's review on their assessment of the non-target arthropod studies
and the Bt degradation in soil studies.
In addition, Monsanto has submitted an insect resistance
management plan (IRM) intended to be used for a 3-year interim period
while further scientific studies are conducted to refine the plan based
on actual commercial field experience. EPA has cooperated with
researchers working with corn rootworm in its evaluation of the
Monsanto proposed IRM plan. The Agency will also be seeking the advice
of the FIFRA SAP regarding their assessment of the IRM plan. The
guidance provided by the FIFRA SAP along with comments provided by the
public will be considered by the Agency in making its decision on the
application for registration for products containing Cry3Bb1.
C. Request for Nominations to Serve as Ad-Hoc Members of the FIFRA
Scientific Advisory Panel 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: Insect biology, insect resistance management, and
non-target effects. 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 by August 5, 2002.
The criteria for selecting scientists to serve on the Panel 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 Panel nominee is considered to assist in a review by the 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 Panel nominee is required
to submit a Confidential Financial Disclosure Report 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 formal conflicts of interest before the nominee is
considered to serve on the Panel. Selected Panel members will be hired
as a Special Government Employee. The Agency will review all
nominations; a decision on Panel members for the meeting will be posted
on the FIFRA SAP web site or may be obtained by contacting the Public
Information and Records Integrity Branch at the address or telephone
number listed in Unit I. of the SUPPLEMENTARY INFORMATION.
D. FIFRA SAP Meeting Minutes
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 60 days. The minutes
will be posted on the FIFRA SAP web site or may be obtained by
contacting the Public Information and Records Integrity Branch at the
address or telephone number listed in Unit I. of the SUPPLEMENTARY
INFORMATION.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: July 17, 2002.
Sherell A. Sterling | |
