FIFRA Scientific Advisory Panel; Notice of Public Meeting, 55836-55839 [05-19129]

Download as PDF 55836 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices EIS No. 20050387, Draft EIS, FHW, TN, Interstate 69 Segment of Independent Utility #8, Construction from TN–385 (Paul Barrett Parkway) in Millington, TN to I–155/US51 in Dyersburg, TN, Funding, Shelby, Tipton, Lauderdale and Dyer Counties, TN, Comment Period Ends: 11/07/2005, Contact: Walter Boyd 615–781–5774. EIS No. 20050388, Draft EIS, FRC, WA, Lewis River Hydroelectric Projects, Relicensing the Swift No. 1 (FERC No. 2111–018), Swift No. 2 (FERC No. 2213–011), Yale (FERC No. 2071– 013), Merwin (FERC No. 935–053) Project, Application for Relicense, North Fork Lewis River, Cowlitz, Clark and Shamania Counties, WA, Comment Period Ends: 11/23/2005, Contact: Jon Cofrancesco 202–502– 8951. EIS No. 20050389, Draft EIS, FHW, CO, US Highway 160, Transportation Improvements from Junction US 160/ 550 Durango—East to Bayfield, U.S. Army COE Section 404 Permit, La Plata County, CO, Comment Period Ends: 11/07/2005, Contact: Joseph Duran 720–963–3006. Amended Notices EIS No. 20050369, Final EIS, FHW, MD, MD–32 Planning Study, Transportation Improvements from MD–108 to Interstate 70, Funding, Howard County, MD, Wait Period Ends: 10/11/2005, Contact: Caryn Brookman 410–962–4440. Revision to FR Notice Published on 9/9/2005. Correction to Comment Due Date from 10/24/05 to 10/11/2005 and to the Title. Dated: September 20, 2005. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. 05–19052 Filed 9–22–05; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [OPP–2005–0249; FRL–7735–1] FIFRA Scientific Advisory Panel; Notice of Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: I. General Information SUMMARY: There will be a meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review plant-incorporated protectants based on virus coat protein genes: science issues associated with a review of proposed rules. VerDate Aug<31>2005 15:21 Sep 22, 2005 Jkt 205001 The meeting will be held from December 6–7, 2005, from 8:30 a.m. to 5:00 p.m, eastern time. 1. Comments: For the deadlines for submission of requests to present oral comments and submission of written comments, see Unit I.E. of the SUPPLEMENTARY INFORMATION. 2. Nominations: Nominations of scientific experts to serve as ad hoc members of the FIFRA SAP for this meeting should be provided on or before October 5, 2005. 3. Special accommodations: For information on access or services for individuals with disabilities, and to request accommodation of a disability, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT, preferably at least 12 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 Hotel, 2650 Jefferson Davis Highway, Arlington, VA 22202. The telephone number for the Holiday Inn-National Airport is (703) 684–7200. 1. Comments: Written comments may be submitted electronically (preferred), or through hand delivery/courier, or by mail. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. 2. Nominations, requests to present oral comments, and special seating: To submit nominations for ad hoc member 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 identification (ID) number OPP–2005– 0249 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: lewis.paul@epa.gov. SUPPLEMENTARY INFORMATION: DATES: 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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 ID number OPP–2005– 0249. 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, 1801 S. Bell St., 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 https://www.epa.gov/fedrgstr/. EPA’s position paper, charge/ questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad-hoc members for this meeting) and the meeting agenda will be available as soon as possible, but no later than mid November 2005. 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 https:// 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 https://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 the EPA Dockets. E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 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 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 VerDate Aug<31>2005 15:21 Sep 22, 2005 Jkt 205001 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 https://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–2005–0249. 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 opp-docket@epa.gov, Attention: Docket ID Number OPP– 2005–0249. 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. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 55837 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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP–2005–0249. 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–2005–0249. 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–2005–0249 in the subject line on the first page of your request. E:\FR\FM\23SEN1.SGM 23SEN1 55838 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 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 the FIFRA SAP is strongly advised to submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon, eastern time, November 30, 2005, 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 presented before the 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 the FIFRA SAP members 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.C., no later than noon, eastern time, November 30, 2005, to provide the FIFRA SAP members 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. There is no limit on the extent of written comments for consideration by the 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. For information on access or services for individuals with disabilities, please contact Paul Lewis at (202) 564–8450 or lewis.paul@epa.gov). To request accommodation of a disability, please contact Paul Lewis, preferably at least 12 days prior to the meeting, to give EPA as much time as possible to process your request. 4. Request for nominations to serve as ad hoc members of the FIFRA SAP for this meeting. As part of a broader process for developing a pool of candidates for each meeting, the FIFRA VerDate Aug<31>2005 15:21 Sep 22, 2005 Jkt 205001 SAP staff routinely solicit the stakeholder community for nominations of prospective candidates for service as ad hoc members of the 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: risk assessment of virus-resistant transgenic plants, plant virology, plant virus recombination, gene flow/weed issues, posttranscriptional gene silencing and human/non-target exposure to novel proteins. 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 October 5, 2005. 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 the 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 the 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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 the 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 the 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 candidates 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 the 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 web site or may be obtained by contacting the PIRIB at the address or telephone number listed in Unit I. 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 E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 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. potential for non-target impacts, and the potential environmental consequences associated with gene flow and recombination. B. Public Meeting The FIFRA SAP will meet to consider and review plant-incorporated protectants based on virus coat protein genes: science issues associated with a review of proposed rules. A plantincorporated protectant (PIP) is a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. The term includes both active and inert ingredients. PIPs are regulated as pesticides by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because they meet the FIFRA definition of a pesticide, being intended for preventing, destroying, repelling, or mitigating a pest. Residues of PVCP-PIPs in or on food are also subject to FFDCA section 408 because PIPs meet the FFDCA definition of a pesticide chemical. PIPs may occur naturally or be introduced into plants by conventional breeding or genetic engineering. PVCPPIPs are PIPs in which inserted genetic material is derived from a plant virus sequence that encodes a plant virus coat protein. Plant virus coat proteins encapsidate the viral nucleic acid and are known to have a role in nearly every stage of viral infection including replication, movement throughout an infected plant, and transport from plant to plant. Incorporation of plant virus coat protein gene sequences into plant genomes has been found to confer resistance to the virus from which it was derived and often to related viruses. EPA is seeking the assistance of the FIFRA SAP in evaluating several issues associated with the review of proposed rules that would exempt certain PVCPPIPs from regulation under FFDCA and/ or FIFRA. These issues include the potential human health effects from exposure to residues of PVCP-PIPs, the Dated: September 19, 2005. Clifford J. Gabriel, Director, Office of Science Coordination and Policy. [FR Doc. 05–19129 Filed 9–22–05; 8:45 am] VerDate Aug<31>2005 15:21 Sep 22, 2005 Jkt 205001 C. FIFRA SAP Meeting Minutes 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 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. BILLING CODE 6560–50–S [OPP–2004–0348; FRL–7733–5] Malathion; Revised Risk Assessments, Notice of Availability, and Solicitation of Risk Reduction Options Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: This notice announces the availability of EPA’s revised human health risk assessment and as well as the start of a 60-day comment period ecological risk assessment for the organophosphate pesticide malathion. A revised human health assessment on malathion was conducted to incorporate toxicity data which EPA received after 2000. Since no additional ecological data on malathion has been received after 2000, EPA’s ecological risk characterization has remained unchanged. This notice also solicits information or data from stakeholders and interested parties to help refine the malathion risk assessment, and encourages parties to suggest risk management ideas or proposals to address the potential risks which have been identified. EPA is developing an Interim Reregistration Eligibility Decision (IRED) for malathion through the full, 6-Phase public participation process, which in this case includes reissuing the revised risk assessment for an additional Phase 5 public comment period. The Agency uses this process to involve the public in developing Frm 00025 Fmt 4703 pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards. DATES: Comments must be received on or before November 22, 2005. ADDRESSES: Comments, identified by identificaiton (ID) number OPP–2004– 0348, may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Tom Moriarty, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 305– 5035; fax number: (703) 308–8005; email address: moriarty.thomas@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information ENVIRONMENTAL PROTECTION AGENCY PO 00000 55839 Sfmt 4703 A. Does this Action Apply to Me? This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may 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 person 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 ID number OPP–2004– 0348. 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, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55836-55839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19129]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0249; FRL-7735-1]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  There will be a meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review plant-incorporated protectants based on virus coat 
protein genes: science issues associated with a review of proposed 
rules.

DATES:  The meeting will be held from December 6-7, 2005, from 8:30 
a.m. to 5:00 p.m, eastern time.
    1. Comments: For the deadlines for submission of requests to 
present oral comments and submission of written comments, see Unit I.E. 
of the SUPPLEMENTARY INFORMATION.
    2. Nominations: Nominations of scientific experts to serve as ad 
hoc members of the FIFRA SAP for this meeting should be provided on or 
before October 5, 2005.
    3. Special accommodations: For information on access or services 
for individuals with disabilities, and to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT, preferably at least 12 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 Hotel, 2650 Jefferson Davis Highway, Arlington, VA 22202. The 
telephone number for the Holiday Inn-National Airport is (703) 684-
7200.
    1. Comments: Written comments may be submitted electronically 
(preferred), or through hand delivery/courier, or by mail. Follow the 
detailed instructions as provided in Unit I. of the SUPPLEMENTARY 
INFORMATION.
    2. Nominations, requests to present oral comments, and special 
seating: To submit nominations for ad hoc member 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 identification (ID) number 
OPP-2005-0249 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: 
lewis.paul@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. 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 ID number OPP-2005-0249. 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, 1801 S. Bell St., 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 https://www.epa.gov/fedrgstr/.
    EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP 
composition (i.e., members and ad-hoc members for this meeting) and the 
meeting agenda will be available as soon as possible, but no later than 
mid November 2005. 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 https://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 https://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 the EPA Dockets.

[[Page 55837]]

 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 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 https://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-2005-0249. 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 opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2005-0249. 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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0249. 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-2005-0249.

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-2005-0249 in the subject line on the 
first page of your request.

[[Page 55838]]

    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 the FIFRA SAP is strongly 
advised to submit their request to the DFO listed under FOR FURTHER 
INFORMATION CONTACT no later than noon, eastern time, November 30, 
2005, 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 presented before the 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 the FIFRA SAP 
members 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.C., no later than noon, eastern time, November 
30, 2005, to provide the FIFRA SAP members 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. There is no limit on the extent 
of written comments for consideration by the 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. For information on access or services for individuals 
with disabilities, please contact Paul Lewis at (202) 564-8450 or 
lewis.paul@epa.gov). To request accommodation of a disability, please 
contact Paul Lewis, preferably at least 12 days prior to the meeting, 
to give EPA as much time as possible to process your request.
    4. Request for nominations to serve as ad hoc members of the 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 the 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: risk assessment of virus-resistant 
transgenic plants, plant virology, plant virus recombination, gene 
flow/weed issues, post-transcriptional gene silencing and human/non-
target exposure to novel proteins. 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 October 5, 2005. 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 the 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 the 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 the 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 the 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 candidates 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 the 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 web site or may be obtained by 
contacting the PIRIB at the address or telephone number listed in Unit 
I.

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

[[Page 55839]]

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 plant-incorporated 
protectants based on virus coat protein genes: science issues 
associated with a review of proposed rules. A plant-incorporated 
protectant (PIP) is a pesticidal substance that is intended to be 
produced and used in a living plant, or in the produce thereof, and the 
genetic material necessary for production of such a pesticidal 
substance. The term includes both active and inert ingredients. PIPs 
are regulated as pesticides by EPA under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) because they meet the FIFRA 
definition of a pesticide, being intended for preventing, destroying, 
repelling, or mitigating a pest. Residues of PVCP-PIPs in or on food 
are also subject to FFDCA section 408 because PIPs meet the FFDCA 
definition of a pesticide chemical.
    PIPs may occur naturally or be introduced into plants by 
conventional breeding or genetic engineering. PVCP-PIPs are PIPs in 
which inserted genetic material is derived from a plant virus sequence 
that encodes a plant virus coat protein. Plant virus coat proteins 
encapsidate the viral nucleic acid and are known to have a role in 
nearly every stage of viral infection including replication, movement 
throughout an infected plant, and transport from plant to plant. 
Incorporation of plant virus coat protein gene sequences into plant 
genomes has been found to confer resistance to the virus from which it 
was derived and often to related viruses.
    EPA is seeking the assistance of the FIFRA SAP in evaluating 
several issues associated with the review of proposed rules that would 
exempt certain PVCP-PIPs from regulation under FFDCA and/or FIFRA. 
These issues include the potential human health effects from exposure 
to residues of PVCP-PIPs, the potential for non-target impacts, and the 
potential environmental consequences associated with gene flow and 
recombination.

C. FIFRA SAP Meeting Minutes

    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 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: September 19, 2005.
 Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-19129 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S
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