

[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 athttp://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]

BILLING CODE 6560-50-S
