FIFRA Scientific Advisory Panel; Notice of Public Meeting, 21746-21749 [05-8377]

Download as PDF 21746 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices launch full text Web sites containing all required service information for 1996 and later model years. In order to assess the effectiveness of the web site provisions of the regulations, EPA believes that input from independent technicians must be of primary consideration. As part of our broader efforts to evaluate the OEM web sites, EPA is initiating a process to gather feedback directly from the technician community on their experiences with the web sites and to communicate those findings directly to the OEMs and the service industry as a whole. EPA staff will use this data in conjunction with other internal analyses to assess the effectiveness of the service information web sites that are required by the regulations. In addition, this information will be used by the Agency to determine if manufacturer guidance or changes to the regulations are needed. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9. The EPA would like to solicit comments to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Burden Statement: Participation in the audit requires the availability of desk top or lap top computers in the maintenance facility or shop. In addition, internet access is needed in the facility in order to access the information on individual automobile manufacturer Web sites. It is anticipated that a vast majority of vehicle repair facilities have already made these capital investments for the day to day operations of their businesses and that no additional costs will be incurred by technicians who participate in the audit. In addition, the automobile VerDate jul<14>2003 20:11 Apr 26, 2005 Jkt 205001 manufacturers have agreed to arrange for free access to all their Web sites for participants for the 3–4 month duration of the audit. Therefore, participants will not incur any additional charges or fees as a result of participating in the audit. EPA otherwise anticipates approximately 250 technicians to and that they will spend approximately 1–2 hours per week over a 12-week time period to electronically complete and return short audit questionnaires. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Dated: April 18, 2005. Karl Simon, Acting Director, Office of Transportation and Air Quality. [FR Doc. 05–8439 Filed 4–26–05; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY Nominations: Nominations of scientific experts to serve as ad hoc members of the FIFRA SAP for this meeting should be provided on or before May 9, 2005. Special seating: Requests for special seating arrangements should be made at least 5 business days prior to the meeting. ADDRESSES: The meeting will be held at the Holiday Inn-National Airport, 2650 Jefferson Davis Highway, Arlington,VA 22202. The telephone number for the Holiday Inn-National Airport is (703) 684–7200. Comments: Written comments may be submitted electronically (preferred), through hand delivery/courier, or by mail. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. Nominations, requests to present oral comments, and special seating: To submit nominations for ad hoc members 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 ID number OPP–2005–0102 in the subject line on the first page of your request. 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 address:bailey.joseph@epa.gov. SUPPLEMENTARY INFORMATION: [OPP–2005–0102; FRL–7710–7] I. General Information FIFRA Scientific Advisory Panel; Notice of Public Meeting 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. Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 carbamate dietary exposure assessment incorporating cholinesterase recovery into CARES–compatible modules. The meeting will be held on June 14-15, 2005, from 8:30 a.m. to approximately 5 p.m., eastern time. Comments: For the deadlines for the submission of requests to present oral comments and the submission of written comments, see Unit I.E. of the SUPPLEMENTARY INFORMATION. DATES: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices under docket ID number OPP–2005– 0102. 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 consultants for this meeting), and the meeting agenda will be available as soon as possible, but no later than mid-to late May 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 EPA Dockets. 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 VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 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 email address or other contact information in the body of your PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 21747 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–2005–0102. 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– 2005–0102. 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 South Bell St., Arlington, VA, Attention: Docket ID E:\FR\FM\27APN1.SGM 27APN1 21748 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices Number OPP–2005–0102. 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–2005–0102. 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–2005–0102 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 VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 no later than noon, eastern time, June 7, 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 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 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, May 31, 2005, to provide FIFRA SAP the time necessary to consider and review the written comments. The DFO listed under FOR FURTHER INFORMATION CONTACT should be notified that comments have been submitted to the docket or a courtesy copy of the comments should be provided to the DFO. 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 5 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 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: cholinesterase inhibition and recovery, pharmacokinetics/pharmocodynamics, statistics, exposure modeling. Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the FURTHER INFORMATION CONTACT PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 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 May 9, 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 10 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 EPA (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 E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices 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 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, 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 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 Acute dietary exposure to pesticides is currently assessed using probabilistic VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 models (DEEM–FCID, LifeLine, CARES) that combine the entire distributions of consumption and residue data. These models perform exposure assessments using total daily 24 hour consumption amounts. It is known, however, that the acute toxic effects of certain classes of chemicals are rapidly reversible. In the case of cholinesterase inhibition by carbamates, reversibility occurs within minutes to hours. Thus, the effect of exposure to carbamates should be assessed using consumption data that refer to single eating occasions, or shorter periods of time (less than 24 hours) to reflect the toxicology profiles of these compounds. The FIFRA Scientific Advisory Panel (February 1999) concurred with the validity of using the time-dependent recovery of acetylcholinesterase to assess risks from repeated exposures to aldicarb. Recent advances in modeling have provided the capability to conduct exposure modeling in periods less than 24 hours. Two modules, designed for compatibility with the CARES model maintained by the International Life Sciences Institute, will be presented. The first module, referred to as the Dietary Minute Module (DMM) allocates daily consumption amount for an individual by minute of a day as recorded in the CSFII database. A user determined elapsed time interval is then applied that reflects the reversibility of cholinesterase activity for the carbamate of interest based on pharmacodynamic or toxicological studies. The time entered defines discrete eating occasions for an individual’s day. Each discrete eating occasion ends when a period of consumption is followed by an elapsed time interval in which no consumption of carbamate residues has occurred. A distribution of exposure for all individuals’ discrete eating occasions within a day for all days and individuals in the population of interest is then created. The second module, referred to as the Cholinesterase Activity Module (CAM), is a refinement of the DMM. It incorporates the time course for reversibility of exposure to an acetylcholinesterase inhibitor, rather than assuming a fixed elapsed time period. Time dependent changes in exposure are determined from corresponding changes in acetylcholinesterase activity. A more realistic estimate of exposure can then be calculated from a summation of residual activity from all eating events. C. FIFRA SAP Meeting Minutes The FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency in approximately 90 days after the PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 21749 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: April 19, 2005. Clifford J. Gabriel, Director, Office of Science Coordination and Policy. [FR Doc. 05–8377 Filed 4–26–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [OPP–2005–0101; FRL–7712–9] Pesticide Program Dialogue Committee and Consumer Pesticide Label Improvement Work Group; Notice of Public Meetings Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: Pursuant to the Federal Advisory Committee Act, EPA gives notice of a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 11, and 12, 2005. A draft agenda has been developed and is posted on EPA’s web site. Agenda topics will include: Environmental Indicators and Results; Worker Safety Activities; Endangered Species; a report from PPDC’s Registration Review Work Group and the PRIA (Pesticide Registration Improvement Act) Process Improvements Work Group; program updates on Registration, Reregistration/ Tolerance Reassessment, Fumigants, Human Studies, Mosquito Labeling, Spray Drift, Globally Harmonized System of Classification and Labeling of Chemicals (GHS), and Data Requirements for Registration (40 CFR part 158). The PPDC Consumer Pesticide Label Improvement Work Group will meet on May 12, 2005. An agenda for this meeting has been developed and is posted on EPA’s website. DATES: The PPDC meeting will be held on Wednesday, May 11, 2005 from 9 a.m. to 5 p.m., and on Thursday, May 12, 2005, from 9 a.m. to 1 p.m. The PPDC Consumer Pesticide Label Improvement Work Group will meet on Thursday, May 12, 2005, from 1 p.m. to 5 p.m. ADDRESSES: Both meetings will be held at the National Press Club, 529 14th St., E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21746-21749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8377]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0102; FRL-7710-7]


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 carbamate dietary exposure assessment incorporating 
cholinesterase recovery into CARES-compatible modules.

DATES: The meeting will be held on June 14-15, 2005, from 8:30 a.m. to 
approximately 5 p.m., eastern time.
     Comments: For the deadlines for the submission of requests to 
present oral comments and the submission of written comments, see Unit 
I.E. 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 May 9, 2005.
     Special seating: Requests for special seating arrangements should 
be made at least 5 business days prior to the meeting.

ADDRESSES: The meeting will be held at the Holiday Inn-National 
Airport, 2650 Jefferson Davis Highway, Arlington,VA 22202. The 
telephone number for the Holiday Inn-National Airport is (703) 684-
7200.
     Comments: Written comments may be submitted electronically 
(preferred), through hand delivery/courier, or by mail. Follow the 
detailed instructions as provided in Unit I. of the SUPPLEMENTARY 
INFORMATION.
     Nominations, requests to present oral comments, and special 
seating: To submit nominations for ad hoc members 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 ID number OPP-2005-0102 in 
the subject line on the first page of your request.

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 
address: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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action

[[Page 21747]]

under docket ID number OPP-2005-0102. 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 consultants for this meeting), and the 
meeting agenda will be available as soon as possible, but no later than 
mid-to late May 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 EPA Dockets. 
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-2005-0102. 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-2005-0102. 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 South Bell St., Arlington, VA, Attention: Docket ID

[[Page 21748]]

Number OPP-2005-0102. 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-2005-0102.

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-2005-0102 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 time, June 7, 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 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 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, May 31, 2005, to 
provide FIFRA SAP the time necessary to consider and review the written 
comments. The DFO listed under FOR FURTHER INFORMATION CONTACT should 
be notified that comments have been submitted to the docket or a 
courtesy copy of the comments should be provided to the DFO. 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 5 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 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: cholinesterase inhibition and 
recovery, pharmacokinetics/pharmocodynamics, statistics, exposure 
modeling. 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 May 9, 
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 10 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 EPA (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

[[Page 21749]]

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 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, 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 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

    Acute dietary exposure to pesticides is currently assessed using 
probabilistic models (DEEM-FCID, LifeLine, CARES) that combine the 
entire distributions of consumption and residue data. These models 
perform exposure assessments using total daily 24 hour consumption 
amounts. It is known, however, that the acute toxic effects of certain 
classes of chemicals are rapidly reversible. In the case of 
cholinesterase inhibition by carbamates, reversibility occurs within 
minutes to hours. Thus, the effect of exposure to carbamates should be 
assessed using consumption data that refer to single eating occasions, 
or shorter periods of time (less than 24 hours) to reflect the 
toxicology profiles of these compounds. The FIFRA Scientific Advisory 
Panel (February 1999) concurred with the validity of using the time-
dependent recovery of acetylcholinesterase to assess risks from 
repeated exposures to aldicarb.
    Recent advances in modeling have provided the capability to conduct 
exposure modeling in periods less than 24 hours. Two modules, designed 
for compatibility with the CARES model maintained by the International 
Life Sciences Institute, will be presented. The first module, referred 
to as the Dietary Minute Module (DMM) allocates daily consumption 
amount for an individual by minute of a day as recorded in the CSFII 
database. A user determined elapsed time interval is then applied that 
reflects the reversibility of cholinesterase activity for the carbamate 
of interest based on pharmacodynamic or toxicological studies. The time 
entered defines discrete eating occasions for an individual's day. Each 
discrete eating occasion ends when a period of consumption is followed 
by an elapsed time interval in which no consumption of carbamate 
residues has occurred. A distribution of exposure for all individuals' 
discrete eating occasions within a day for all days and individuals in 
the population of interest is then created. The second module, referred 
to as the Cholinesterase Activity Module (CAM), is a refinement of the 
DMM. It incorporates the time course for reversibility of exposure to 
an acetylcholinesterase inhibitor, rather than assuming a fixed elapsed 
time period. Time dependent changes in exposure are determined from 
corresponding changes in acetylcholinesterase activity. A more 
realistic estimate of exposure can then be calculated from a summation 
of residual activity from all eating events.

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: April 19, 2005.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.

[FR Doc. 05-8377 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S
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