[Federal Register Volume 67, Number 142 (Wednesday, July 24, 2002)]
[Notices]
[Pages 48461-48463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18725]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0157; FRL-7190--2]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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: 
[email protected].

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: [email protected]. 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

[[Page 48463]]

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,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 02-18725 Filed 7-23-02; 8:45 am]
BILLING CODE 6560-50-S