Flumiclorac pentyl; Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability, 60824-60826 [05-20708]
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Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices
questions, consult the person listed
under FOR FURTHER INFORMATION
CONTACT.
II. What Action is EPA Taking?
This document reopens the public
comment period established in the
Federal Register of August 3, 2005 (70
FR 44632) (FRL–7729–2). In that
document, EPA made available the
human health risk assessment for
ethylene oxide (ETO). ETO is a
fumigant/sterilant used to sterilize
medical or laboratory equipment,
pharmaceuticals, and aseptic packaging,
or to reduce microbial load on
cosmetics, whole and ground spices or
other seasoning materials, and artifacts,
archival material or library objects. The
Agency developed this risk assessment
as part of its public process for making
pesticide reregistration eligibility and
tolerance reassessment decisions.
Through these programs, EPA is
ensuring that pesticides meet current
standards under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA). The Agency received a request
by a stakeholder to extend the comment
period. EPA is hereby reopening the
comment period, which ended on
October 3, 2005; comments must now be
received on or before [insert date 30
days after date of publication in the
Federal Register]. This extension is
being given based on the request to have
additional time to review the extensive
amount of information provided and the
nature of the issues involved.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: October 5, 2005.
Peter Caulkins,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
[FR Doc. 05–20821 Filed 10–18–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0229; FRL 7740–4]
Flumiclorac pentyl; Tolerance
Reassessment Decision for Low Risk
Pesticide; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
availability of EPA’s Tolerance
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Reassessment Decision (TRED) for the
pesticide flumiclorac pentyl, and opens
a public comment period on this
document, related risk assessments, and
other support documents. EPA has
reviewed the low risk pesticide
flumiclorac pentyl 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 must be received on
or before November 18, 2005.
ADDRESSES: Comments, identified by
docket identification (ID) number OPP–
2005–0229 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:
Tawanda Spears, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460–0001;
telephone number: (703) 308–8050; fax
number: (703) 308–8005; e-mail address:
spears.tawanda@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–2005–
0229. 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
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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/.
An electronic version of the public
docket is available through EPA’s
electronic public docket and comment
system, EPA Dockets. You may use EPA
Dockets at https://www.epa.gov/edocket/
to submit or view public comments,
access the index listing of the contents
of the official public docket, and to
access those documents in the public
docket that are available electronically.
Once in the system, select ‘‘search,’’
then key in the appropriate docket ID
number.
Certain types of information will not
be placed in the EPA Dockets.
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
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Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices
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 email 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.
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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–2005–0229. 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 toopp-docket@epa.gov,
Attention: Docket ID Number OPP–
2005–0229. 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–2005–0229.
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–2005–0229. 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
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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 completed its evaluation of the
uses of flumiclorac pentyl, reassessed
five (5) existing tolerances or legal
residue limits, and reached a tolerance
reassessment decision for this low risk
pesticide on August 23, 2005.
Flumiclorac pentyl is a post-emergence
herbicide used on field corn, soybeans
and non-crop areas, such as: industrial
sites, airports, military installations,
roadsides and associated rights-of-way,
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Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices
and other similar areas to control a
selected group of broadleaf weeds,
specifically morning-glory and velvet
leaf. Although there are no labeled
residential homeowner uses, there is
potential risk for non-occupational
exposure from other treated areas, such
as golf courses, athletic fields,
recreational areas, schools, apartment
buildings, etc. The Agency is now
issuing for comment the resulting
Report on Food Quality Protection Act
(FQPA) Tolerance Reassessment
Progress and Risk Management Decision
for flumiclorac pentyl, known as a
TRED, as well as related risk
assessments and technical support
documents.
EPA developed the flumiclorac pentyl
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 flumiclorac pentyl tolerances
included in this notice.
The flumiclorac pentyl TRED presents
the Agency’s tolerance reassessment
conclusions for flumiclorac pentyl
alone; however, section 408(b)(2)(D)(v)
of the FFDCA directs the Agency also to
consider available information on the
cumulative risk from substances sharing
a common mechanism of toxicity.
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
flumiclorac pentyl and any other
substances, and flumiclorac pentyl does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
flumiclorac pentyl has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
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EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
EPA is applying the principles of
public participation to all pesticides
undergoing reregistration and tolerance
reassessment. The Agency’s Pesticide
Tolerance Reassessment and
Reregistration; Public Participation
Process, published in the Federal
Register of May 14, 2004 (69 FR 26819)
(FRL–7357–9), explains that 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 flumiclorac pentyl,
which pose no risk concerns, have low
use, affect few if any stakeholders, and
require no risk mitigation. Once EPA
assesses uses and risks for such low risk
pesticides, the Agency may go directly
to a decision and prepare a document
summarizing its findings, such as the
flumiclorac pentyl TRED.
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. Flumiclorac
pentyl, however, poses no risks that
require mitigation. The Agency
therefore is issuing the flumiclorac
pentyl 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 the
closing date. These comments will
become part of the Agency Docket for
flumiclorac pentyl. Comments received
after the close of the comment period
will be marked ‘‘late.’’ EPA is not
required to consider these late
comments.
EPA will 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
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requiring changes, the decisions
reflected in the TRED will be
implemented as presented. These
decisions may be supplemented by risk
mitigation measures when EPA
considers its cumulative assessment of
pesticides.
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: October 5, 2005.
Peter Caulkins,
Acting Director, Special Review and
Reregistration Division, Office of Pesticide
Programs.
[FR Doc. 05–20708 Filed 10–18–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2004–0182; FRL–7727–6]
Pesticide Product Registrations;
Conditional Approval
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Notice.
SUMMARY: This notice announces
Agency approval of applications
submitted by Monsanto Company, to
conditionally register the pesticide
products, Event MON 863: Corn
Rootworm Protected Corn (ZMIR13L)
and YieldGard Plus containing a new
active ingredient not included in any
previously registered products pursuant
to the provisions of section 3(c)(7)(C) of
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended.
FOR FURTHER INFORMATION CONTACT:
Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8715;e-mail
address:mendelsohn.mike@epa.gov.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Notices]
[Pages 60824-60826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20708]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0229; FRL 7740-4]
Flumiclorac pentyl; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide flumiclorac pentyl, and
opens a public comment period on this document, related risk
assessments, and other support documents. EPA has reviewed the low risk
pesticide flumiclorac pentyl 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 must be received on or before November 18, 2005.
ADDRESSES: Comments, identified by docket identification (ID) number
OPP-2005-0229 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: Tawanda Spears, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001; telephone number: (703) 308-8050; fax
number: (703) 308-8005; e-mail address: spears.tawanda@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-2005-0229. 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/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
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
[[Page 60825]]
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 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-2005-0229. 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 toopp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0229. 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-2005-0229.
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-2005-0229. 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 completed its evaluation of the uses of flumiclorac pentyl,
reassessed five (5) existing tolerances or legal residue limits, and
reached a tolerance reassessment decision for this low risk pesticide
on August 23, 2005. Flumiclorac pentyl is a post-emergence herbicide
used on field corn, soybeans and non-crop areas, such as: industrial
sites, airports, military installations, roadsides and associated
rights-of-way,
[[Page 60826]]
and other similar areas to control a selected group of broadleaf weeds,
specifically morning-glory and velvet leaf. Although there are no
labeled residential homeowner uses, there is potential risk for non-
occupational exposure from other treated areas, such as golf courses,
athletic fields, recreational areas, schools, apartment buildings, etc.
The Agency is now issuing for comment the resulting Report on Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for flumiclorac pentyl, known as a TRED, as well as
related risk assessments and technical support documents.
EPA developed the flumiclorac pentyl 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
flumiclorac pentyl tolerances included in this notice.
The flumiclorac pentyl TRED presents the Agency's tolerance
reassessment conclusions for flumiclorac pentyl alone; however, section
408(b)(2)(D)(v) of the FFDCA directs the Agency also to consider
available information on the cumulative risk from substances sharing a
common mechanism of toxicity. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
flumiclorac pentyl and any other substances, and flumiclorac pentyl
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that flumiclorac pentyl has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
https://www.epa.gov/pesticides/cumulative/.
EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register of May 14,
2004 (69 FR 26819) (FRL-7357-9), explains that 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 flumiclorac
pentyl, which pose no risk concerns, have low use, affect few if any
stakeholders, and require no risk mitigation. Once EPA assesses uses
and risks for such low risk pesticides, the Agency may go directly to a
decision and prepare a document summarizing its findings, such as the
flumiclorac pentyl TRED.
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. Flumiclorac pentyl, however,
poses no risks that require mitigation. The Agency therefore is issuing
the flumiclorac pentyl 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 the closing date.
These comments will become part of the Agency Docket for flumiclorac
pentyl. Comments received after the close of the comment period will be
marked ``late.'' EPA is not required to consider these late comments.
EPA will 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. These decisions
may be supplemented by risk mitigation measures when EPA considers its
cumulative assessment of pesticides.
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: October 5, 2005.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 05-20708 Filed 10-18-05; 8:45 am]
BILLING CODE 6560-50-S
