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Fluridone. September 29, 2004. Tolerance Reassessment Decision (TRED) documents for Low Risk Pesticide; Notice of Availability. Federal Register.
Docket identification (ID) number OPP-2004-0235
TRED documents available for public comment Aug 17, 2004 Human Health Risk Assessment for Fluridone TRED.
35 pages
From:
Timothy C. Dole, CIH, Industrial Hygienist
Christine Olinger, Chemist
Paul Chin, Ph.D., Toxicologist
Reregistration Branch 1
Health Effects Division (7509C)PC Code 112900.
DP Barcode D306456.Aug 12 , 2004 Fluridone Acute and Chronic Dietary Exposure Assessments for the
Reregistration Eligibility Decision8 pages
REVIEWER:
Christine L. Olinger, Chemist
Reregistration Branch I
Health Effects Division (7509C)PC Code: 112900
DP Barcode: D299947April 1, 2004 7 pages
From:
Ibrahim Abdel-Saheb, Ph.D., Agronomist
Peer Reviewed By:
James Breithaupt, Agronomist
Approved By:
Tom Bailey, Ph.D., Branch Chief,
Environmental Risk Branch, Environmental Fate and Effects Division (7507C)PC Code: 112900
DP Barcode: D300012Aug 30, 2004 FLURIDONE: Toxicology Chapter for RED and Updating Executive Summaries for 11 Studies
39 pages
From:
Paul Chin, Ph.D.
Reregistration Branch I
Health Effects Division 7509CPC CODE: 112900
DP
BARCODE: D291522TXR#: 0052046
Sept 20, 2004 6 pages
Submitted by
Debbie Edwards, Ph.D.
Director
Special Review and Reregistration DivisionContact for futher information:
Wilhelmena LivingstonUS EPA OPPT (7508C)
http://www.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-29/p21585.htm[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Notices]
[Page 58161-58164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-59]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0235; FRL-7680-5]
Fluridone; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide fluridone, and opens a
public comment period on this decision, related risk assessments, and
other support documents. EPA has reviewed the low risk pesticide
fluridone through a modified, streamlined version of the public
participation process that the Agency uses to involve the public in
developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.
DATES: Comments, identified by docket identification (ID) number OPP-2004-
[[Page 58162]]
0235, must be received on or before October 29, 2004
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Wilhelmena Livingston, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8025; fax
number: (703) 308-8041; e-mail address: livingston.wilhelmena@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0235. 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 http://www.epa.gov/fedrgstr/.
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 the 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 on 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 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, by mail, or through hand
delivery/courier. 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. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. 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-2004-0235. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or
[[Page 58163]]
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-2004-0235. 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 mail to the mailing address identified in Unit I.C.2. 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 mail. 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-2004-0235.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2004-0235. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. 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 any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful, if you provided the name, date, and Federal
Register citation related to your comments.II. Background
A. What Action is the Agency Taking?
EPA has reassessed the uses of fluridone, reassessed 50 existing
tolerances or legal residue limits, and reached a tolerance
reassessment decision for this low risk pesticide. The Agency is
issuing for comment the resulting report on Food Quality Protection Act
(FQPA) Tolerance Reassessment Progress and Risk Management Decision for
fluridone known as a TRED, as well as related risk assessments and
technical support documents.Fluridone is a systemic herbicide that is used to manage aquatic
weeds in ponds and lakes. It is particularly useful for the control of
hydrilla in the southern states and eurasian milfoil in the northern
states. It inhibits carotene syntheses which causes the loss of
chlorophyll. It is typically applied to the whole water body because it
requires a contact time of 45-days to be effective. Fluridone is not
applied to crops or livestock, but treated water may be used to
irrigate food and feed crops or fed to livestock. The Agency determined
that the dietary, drinking water, and recreational swimmer risks are
not of concern and no risk mitigation is required.EPA developed the fluridone TRED through a modified, streamlined
version of its public process for making tolerance reassessment and
reregistration eligibility decisions. Through these programs, the
Agency is ensuring that pesticides meet current standards under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when the FQPA was enacted, to ensure that these existing
pesticide residue limits for food and feed commodities meet the safety
standard established by the new law. Tolerances are considered
reassessed once the safety finding has been made or a revocation
occurs. EPA has reviewed and made the requisite safety finding for the
fluridone tolerances included in this notice.EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. In
conducting these programs, the Agency is tailoring its public
participation process to be commensurate with the level of risk, extent
of use, complexity of issues, and degree of public concern associated
with each pesticide. EPA can expeditiously reach decisions for
pesticides like fluridone, which pose no risk concerns, and require no
risk mitigation. Once EPA assesses uses and risks for such pesticides,
the Agency may go directly to a decision and prepare a document
summarizing its findings.The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. Fluridone, however, poses no
risks that require mitigation. The Agency, therefore, is issuing the
Fluridone TRED, its risk assessments, and related support documents
simultaneously for public comment. The comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the TRED. All comments should be submitted
using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must
be received by EPA on or before
[[Page 58164]]
the closing date. These comments will become part of the Agency docket
for fluridone. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and electronic EDOCKET. If any comment significantly affects the
document, EPA also, will publish an amendment to the TRED in the
Federal Register. In the absence of substantive comments requiring
changes, the decisions reflected in the TRED will be implemented as
presented.
B. What is the Agency's Authority for Taking this Action?
Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: September 20, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 04-21585 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S