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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: January 25, 2006 (Volume 71, Number 16)]
[Notices]
[Page 4130-4133]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja06-70]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-2006-0035; FRL-7759-7]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review human health and environmental issues associated
with the Event MIR604 Modified Cry3A Protein Bt Corn--Plant
Incorporated Protectant. This product is intended to provide protection
from western, northern, and Mexican corn rootworm larvae.
DATES: The meeting will be held on March 14-15, 2006, from 8:30 a.m. to
approximately 5 p.m., eastern time.
[[Page 4131]]
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 February 6, 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--National
Airport, 2650 Jefferson Davis Hwy., Arlington,VA 22202. The telephone
number for the Holiday Inn--National Airport is (703) 684-7200.
Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0035, by one of the following methods:
? http://www.regulations.gov/. 
Follow the on-line
instructions for submitting comments.
? E-mail: opp-docket@epa.gov.
? Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0035. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0035. 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm.
Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the docket facility 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: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (202) 564-2045; fax number: (202) 564-8382; e-mail addresses:
bailey.joseph@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-2006-0035 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
[[Page 4132]]
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 time, March 7, 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 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, written comments will be accepted
until the date of the meeting (unless otherwise stated), the Agency
encourages that written comments be submitted, using the instructions
under ADDRESSES no later than noon, eastern time, February 28, 2006, to
provide 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
comments for consideration by 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 and assistance for the hearing
impaired, 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 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 FIFRA SAP.
Any interested person or organization may nominate qualified
individuals to be considered as prospective candidates for a specific
meeting. Individuals nominated for this meeting should have expertise
in one or more of the following areas: Corn ecosystem entomology,
protein chemistry, and allergenicity. Nominees should be scientists who
have sufficient professional qualifications, including training and
experience, to be capable of providing expert comments on the
scientific 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 February 6, 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 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 the 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 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 12 ad hoc scientists.
If a prospective candidate for service on 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 U.S. 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 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 PIRIB at the address or telephone number listed under ADDRESSES.
II. Background
A. Purpose of 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 registrations pursuant to
section 6(b)(2) 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, 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 FIFRA SAP for staggered terms of 4 years, based on
recommendations from the National Institutes of Health and the National
Science Foundation.
[[Page 4133]]
Section 104 of FQPA (Public Law 104-170) established the FQPA
Science Review Board (SRB). These scientists shall be available to
FIFRA SAP on an ad hoc basis to assist in reviews conducted by FIFRA
SAP.
B. Public Meeting
The FIFRA SAP will meet to consider and review human health and
environmental issues associated with the Modified Cry3A protein in
corn. Syngenta Seeds has submitted applications for FIFRA section 3
registrations of the plant-incorporated protectant (PIP) Modified Cry3A
(mCry3A) protein and the genetic material necessary for its production
(via elements of pZM26) in Event MIR604 corn SYN-IR604-8. This product
is intended to provide protection from western, northern, and Mexican
corn rootworm larvae.
The data submitted and cited regarding potential health effects for
the mCry3A protein include the characterization of the expressed mCry3A
protein in corn, acute oral toxicity, in vitro digestibility, and amino
acid homology determinations with known toxins and allergens.
The data submitted and cited regarding potential environmental
effects for the mCry3A protein include non-target insects (honey bee,
lady beetle, Carabid, Rove beetle, and Orius), earthworm, Bobwhite
quail, chicken, and trout studies; as well as soil degradation studies.
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 mid-February 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 PIRIB at the address or telephone
number listed under ADDRESSES.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: January 19, 2006.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-930 Filed 1-24-06; 8:45 am]
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