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FIFRA Scientific Advisory Panel; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 24, 2004 (Volume 69, Number 57)]
[Notices]
[Page 13826-13829]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr04-47]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0071; FRL-7347-8]
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 a model comparison: Dietary and aggregate exposure
in Calendex, CARES, and Lifeline.
DATES: The meeting will be held on April 29 and 30, 2004, 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 April 5, 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
[[Page 13827]]
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 DFO listed under FOR FURTHER
INFORMATION CONTACT. To ensure proper receipt by EPA, your request must
identify docket ID number OPP-2004-0071 in the subject line on the
first page of your response.
FOR FURTHER INFORMATION CONTACT: Myrta Christian, Designated Federal
Official (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: christian.myrta@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 identification (ID) number OPP-2004-0071. 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,
1921 Jefferson Davis Hwy., 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
early April 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.regulations.gov/ 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
[[Page 13828]]
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-2004-0071. 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-2004-0071. 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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2004-0071. 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-2004-0071.
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-2004-0071 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, April 22, 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, 35 mm projector, and 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., no later than noon, eastern time, April 15, 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, 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 to serve as ad hoc members of the FIFRA
SAP for this meeting. The FIFRA SAP staff routinely solicit the
stakeholder community for nominations to serve as ad hoc members of the
FIFRA SAP for each meeting. Any interested person or organization may
nominate qualified individuals to serve on the FIFRA SAP for a specific
meeting. No interested person 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). Individuals nominated should have expertise in
one or more of the following areas: Dietary exposure assessment,
aggregate exposure models, and uncertainty analysis. Nominees should be
scientists who have sufficient professional qualifications, including
training and experience, to be capable of providing expert comments on
the 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 April 5, 2004.
The criteria for selecting scientists to serve on the FIFRA SAP are
that these persons be recognized scientists--experts in their fields;
that they be as impartial and objective as possible; that they
represent an array of backgrounds and perspectives (within their
disciplines); have no financial conflict of interest; have not
previously been involved with the scientific peer review of the
issue(s) presented; and that they be available to participate fully in the
[[Page 13829]]
review, which will be conducted over a relatively short-time frame.
Nominees will be asked to attend the public meetings and to participate
in the discussion of key issues and assumptions at these meetings.
Finally, they will be asked to review and to help finalize the meeting
minutes.
If a FIFRA SAP nominee is considered to assist in a review by the
FIFRA SAP for a particular session, the nominee is subject to the
provisions of 5 CFR part 2634, Executive Branch Financial Disclosure,
as supplemented by EPA in 5 CFR part 6401. As such, the FIFRA SAP
nominee 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
nominee's employment, stocks, and bonds, and where applicable, sources
of research support. EPA will evaluate the nominee's financial
disclosure form to assess that there are no formal conflicts of
interest before the nominee is considered to serve on the FIFRA SAP.
Selected FIFRA SAP members will be hired as a Special Government
Employee. The Agency will review all nominations. 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
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 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 a model comparison:
Dietary and aggregate exposure in Calendex, CARES, and Lifeline. A
major requirement of the FQPA is that exposures to pesticides across
various pathways and routes (e.g., oral exposure through food and
water, dermal exposure through turf uses) be appropriately combined
such that an ``aggregate'' exposure assessment can be performed. Over
the last several years, OPP has sponsored several presentations to the
FIFRA Scientific Advisory Panel of three major pesticide exposure
models which have this aggregation capability: Dietary Exposure
Evaluation Model (DEEM)/Calendex, CARES, and Lifeline. These models all
permit a time-based integration of both residential and dietary (food
and water) exposures to pesticides. This is performed probabilistically
such that aggregation (or combining) of residues across multiple routes
is accounted for in an appropriate and realistic manner.
Past SAP sessions have involved presentations of these three models
on separate occasions and resulted in valuable feedback and
suggestions. The models have been significantly upgraded and improved,
in part, as a result of these SAP comments. The purpose of this 2-day
session is to present the three models jointly and compare exposure
estimates and results generated by each of the three models using a
common dataset for a hypothetical chemical. Pathways which will be
considered are ingestion through food, ingestion through water, and
dermal exposure through lawn treatments. In contrast to previous SAPs
where the model developers were invited to make their presentations to
the SAP, this SAP presentation will demonstrate the results of EPA's
own model runs. A comparison/contrast regarding the methods by which
the models consider and use the data will be considered. Resulting
model outputs will be presented and discussed. The main focus of the
presentation will be comparison of dietary exposures (food + water) as
estimated by each of the three models, but a comparison of exposure
through all three exposure routes considered jointly (food, water, and
residential lawn use) in an an aggregate assessment will also be
presented.
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: March 17, 2004.
Joseph J. Merenda Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 04-6570 Filed 3-23-04; 8:45 am]
BILLING CODE 6560-50-S