[Federal Register Volume 69, Number 201 (Tuesday, October 19, 2004)]
[Notices]
[Pages 61482-61485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23396]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0349; FRL-7684-4]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 1-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review the N-methyl carbamate risk assessment strategies, 
and methodologies for exposure assessment.

DATES: The meeting will be held on December 3, 2004, from 8:30 a.m. to 
approximately 5 p.m., eastern time.
     Comments: 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 October 29, 2004.
     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 Rosslyn at Key 
Bridge, 1900 North Fort Myer Drive, Arlington, VA 22209. The telephone 
number for the Holiday Inn Rosslyn at Key Bridge is (703) 807-2000.
    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 
specialseating: 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-
2004-0349 in the subject line on the first page of your response.

[[Page 61483]]


FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 
number: (202) 564-2045; fax number: (202) 564-8382; e-mail addresses: 
<a href="/cdn-cgi/l/email-protection#80e2e1e9ece5f9aeeaeff3e5f0e8c0e5f0e1aee7eff6"><span class="__cf_email__" data-cfemail="9bf9faf2f7fee2b5f1f4e8feebf3dbfeebfab5fcf4ed">[email protected]</span></a>.

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-2004-0349. 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 <greek-i>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 http://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-November 2004. In addition, the Agency may provide additional 
background documents as the materials become available. You may obtain 
electronic copies of these documents, and certain other related 
documents that might be available electronically, from the FIFRA SAP 
Internet Home Page at http://www.epa.gov/scipoly/sap.
    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 http://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 http://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-2004-0349. The

[[Page 61484]]

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 <a href="/cdn-cgi/l/email-protection#3d524d4d1059525e5658497d584d5c135a524b"><span class="__cf_email__" data-cfemail="d8b7a8a8f5bcb7bbb3bdac98bda8b9f6bfb7ae">[email protected]</span></a>, 
Attention: Docket ID Number OPP-2004-0349. 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 
<greek-i>2, 1801 S. Bell St., Arlington, VA. Attention: Docket ID 
Number OPP-2004-0349. 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-2004-0349.

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-2004-0349 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, November 24, 2004, 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, 35mm 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 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., no later than noon, eastern time, November 19, 
2004, to provide FIFRA SAP the time necessary to consider and review 
the written comments. There is no limit on the extent of written 
comments for consideration by FIFRA SAP. Persons wishing to submit 
written comments at the meeting should contact the DFO listed under FOR 
FURTHER INFORMATION CONTACT and submit 30 copies.
    3. Seating at the meeting. Seating at the meeting will be on a 
first-come basis. Individuals requiring special accommodations at this 
meeting, including wheelchair access 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: Toxicology; 
physiologically-based pharmacokinetic (PBPK) modeling; exposure 
modeling (dietary and residential) including Lifeline, Cares and DEEM/
Calendex; and probabilistic risk assessment. 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 29, 2004. 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

[[Page 61485]]

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 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. EPA will evaluate the candidate's financial 
disclosure form to assess that there are no financial conflicts of 
interest, no appearance of lack of impartiality, and no prior 
involvement with the development of the primary documents under 
consideration 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

     The FIFRA SAP will meet to consider and review the N-methyl 
carbamate cumulative risk assessment (CRA) strategies, and 
methodologies for exposure assessment. The FQPA of 1996 amended the 
laws under which EPA evaluates the safety of pesticide residues in 
food. Section 408(b)(2)(D)(v) and (vi) of the Federal Food, Drug, and 
Cosmetic Act, as amended by FQPA, specifies that when determining the 
safety of a pesticide chemical, EPA shall base its risk assessment on 
aggregate exposure (i.e., total dietary including drinking water, 
residential, and other non-occupational exposure) and available 
information concerning the cumulative effects to human health that may 
result from exposure to pesticides and other substances that have a 
common mechanism of toxicity.
    EPA is currently preparing a CRA for the N-methyl carbamate class 
of pesticides. The specific N-methyl carbamate pesticides which will be 
included in this assessment are the following: Aldicarb; carbaryl; 
carbofuran; formetanate hydrochloride; methiocarb; methomyl; oxamyl; 
pirimicarb; propoxur; and thiodicarb (see Federal Register notice dated 
February 4, 2004 (69 FR 5340) (FRL-7334-4)). As was previously done for 
the CRA for the organophosphorus pesticides, EPA will convene several 
meetings of the FIFRA SAP to review a number of science issues which 
are crucial to the development and completion of the N-methyl carbamate 
CRA.
    The first meeting that is being announced in the Federal Register 
notice will be held on December 3, 2004, and will deal with general 
strategies, and methodologies being considered for use in this CRA and 
discuss some of the overall issues to be covered at a subsequent 
meeting of the SAP scheduled for February 2005.
    A separate Federal Register notice will be issued later announcing 
the February meeting. In addition to general proposed strategies and 
methodologies for the N-methyl carbamate CRA, specific topics to be 
discussed at the December 3, 2004, SAP meeting include, sophisticated 
PBPK modeling, as well as more conventional relative-potency based 
approaches, the interface between the exposure models and the PBPK 
models, and proposals to revise current exposure models to evaluate 
exposure periods of less than 24 hours.

C. FIFRA SAP Meeting Minutes

    The FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency in approximately 60 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: October 12, 2004.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.

[FR Doc. 04-23396 Filed 10-18-04; 8:45 am]
BILLING CODE 6560-50-S


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