Pesticide Product Registrations; Conditional Approval, 60826-60828 [05-20905]
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60826
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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Jkt 208001
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:
E:\FR\FM\19OCN1.SGM
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Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II. of this notice. 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 identification (ID) number
OPP–2004–0182. 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.
In accordance with section 3(c)(2) of
FIFRA, a copy of the approved label, the
list of data references, the data and other
scientific information used to support
registration, except for material
specifically protected by section 10 of
FIFRA, are available for public
VerDate Aug<31>2005
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Jkt 208001
inspection in the Public Information
and Records Integrity Branch,
Information Resources and Services
Division (7502C), Office of Pesticide
Programs, Environmental Protection
Agency, Rm. 119, Crystal Mall #2,
Arlington, VA (703) 305–5805. Requests
for data must be made in accordance
with the provisions of the Freedom of
Information Act and must be addressed
to the Freedom of Information Office
(A–101), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. Such
requests should: Identify the product
name and registration number and
specify the data or information desired.
A paper copy of the fact sheet, which
provides more detail on this
registration, may be obtained from the
National Technical Information Service
(NTIS), 5285 Port Royal Rd.,
Springfield, VA 22161.
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.
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. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
Electronic versions of the MON 863
Fact Sheet and Biopesticide Regulatory
Action Document, as well as the
YieldGard Plus Fact Sheet are available
at https://www.epa.gov/bioopesticides/.
II. Did EPA Conditionally Approve the
Application?
A conditional registration may be
granted under section 3(c)(7)(C) of
FIFRA for a new active ingredient where
certain data are lacking, on condition
that such data are received by the end
of the conditional registration period
and do not meet or exceed the risk
criteria set forth in 40 CFR 154.7; that
use of the pesticide during the
conditional registration period will not
cause unreasonable adverse effects; and
that use of the pesticide is in the public
interest.
The Agency has considered the
available data on the risks associated
with the proposed use of Bacillus
thuringiensis Cry3Bb1 protein and the
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60827
genetic material necessary for its
production (Vector ZMIR13L) in event
MON 863 corn, and information on
social, economic, and environmental
benefits to be derived from such use.
Specifically, the Agency has considered
the nature and its pattern of use,
application methods and rates, and level
and extent of potential exposure. Based
on these reviews, the Agency was able
to make basic health and safety
determinations which show that use of
Bacillus thuringiensis Cry3Bb1 protein
and the genetic material necessary for
its production Vector ZMIR13L in Event
MON 863 corn during the period of
conditional registration will not cause
any unreasonable adverse effect on the
environment, and that use of the
pesticide is, in the public interest.
Consistent with section 3(c)(7)(C) of
FIFRA, the Agency has determined that
these conditional registrations are in the
public interest. Use of the pesticides are
of significance to the user community,
and appropriate labeling, use directions,
and other measures have been taken to
ensure that use of the pesticides will not
result in unreasonable adverse effects to
man and the environment.
The Agency has considered the
available data on the risks associated
with the proposed use of YieldGard Plus
Bacillus thuringiensis Cry3Bb1 protein
and the genetic material necessary for
its production (Vector ZMIR13L) in
Event MON 863 corn stacked with
Bacillus thuringiensis Cry1A(b) delta
endotoxin and the genetic material
necessary for its production in corn via
conventional breeding, and information
on social, economic, and environmental
benefits to be derived from such use.
Based on these reviews, the Agency
was able to make basic environmental,
health, and safety determinations which
show that use of YieldGard Plus
[Bacillus thuringiensis Cry3Bb1 protein
and the genetic material necessary for
its production (Vector ZMIR13L) in
Event MON 863 corn stacked with
Bacillus thuringiensis Cry1A(b) delta
endotoxin and the genetic material
necessary for its production in corn via
conventional breeding], consistent with
the terms and conditions of registration
during the period of conditional
registration, will not significantly
increase the risk of unreasonable
adverse effect on the environment.
The YieldGard Plus product is
conditionally registered in accordance
with FIFRA section 3(c)(7)(B). If the
conditions are not complied with the
registration will be subject to
cancellation in accordance with FIFRA
section 6(e).
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60828
Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices
III. Conditionally Approved
Registrations
EPA issued a notice, published in the
Federal Register of March 13, 2002 (67
FR 11333) (FRL–6827–3), which
announced that Monsanto Company,
800 N. Lindberg Blvd., St. Louis, MO
63167, had submitted an application to
conditionally register the pesticide
product, Event MON 863: Corn
Rootworm Protected Corn (ZMIR13L), a
plant-incorporated protectant (EPA File
Symbol 524-LEI), containing Bacillus
thuringiensis Cry3Bb1 protein and the
genetic material necessary for its
production (Vector ZMIR13L) in corn,
an active ingredient not included in any
previously registered product.
The application was conditionally
approved on February 24, 2003 for the
product listed below:
1. Event MON 863: Corn Rootworm
Protected Corn (ZMIR13L) (EPA
Registration Number 524–528) for use as
a plant-incorporated protectant in corn.
EPA issued a notice, published in the
Federal Register of April 2, 2003 (68 FR
16036) (FRL–7286–1), which announced
that Monsanto Company, 800 N.
Lindberg Blvd., St. Louis, MO 63167,
had submitted an application to
conditionally register the pesticide
product, YieldGard Plus Corn, a plantincorporated protectant (EPA File
Symbol 524-LUL), containing Bacillus
thuringiensis Cry3Bb1 protein and the
genetic material necessary for its
production (Vector ZMIR13L) in corn
and Bacillus thuringiensis CryBacillus
thuringiensis Cry1A(b) delta endotoxin
and the genetic material necessary for
its production in corn via conventional
breeding. The stacking of Bacillus
thuringiensis Cry3Bb1 protein and the
genetic material necessary for its
production (Vector ZMIR13L) in corn
andBacillus thuringiensis Cry1A(b) delta
endotoxin and the genetic material
necessary for its production in corn via
conventional breeding resulted in a
pesticide product involving a changed
use pattern for its active ingredients
pursuant to the provision of section
3(c)(4) of FIFRA.
The application was conditionally
approved on October 25, 2003 for the
product listed below:
2. YieldGard Plus Corn (EPA
Registration Number 524–545) for use as
a plant-incorporated protectant in corn.
List of Subjects
Environmental protection, Chemicals,
Pesticides and pests.
VerDate Aug<31>2005
14:50 Oct 18, 2005
Jkt 208001
Dated: October 11, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. 05–20905 Filed 10–18–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPPT–2005–0053; FRL–7741–9]
Certain New Chemicals; Receipt and
Status Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: Section 5 of the Toxic
Substances Control Act (TSCA) requires
any person who intends to manufacture
(defined by statute to include import) a
new chemical (i.e., a chemical not on
the TSCA Inventory) to notify EPA and
comply with the statutory provisions
pertaining to the manufacture of new
chemicals. Under sections 5(d)(2) and
5(d)(3) of TSCA, EPA is required to
publish a notice of receipt of a
premanufacture notice (PMN) or an
application for a test marketing
exemption (TME), and to publish
periodic status reports on the chemicals
under review and the receipt of notices
of commencement to manufacture those
chemicals. This status report, which
covers the period from September 12,
2005 to September 23, 2005, consists of
the PMNs pending or expired, and the
notices of commencement to
manufacture a new chemical that the
Agency has received under TSCA
section 5 during this time period.
DATES: Comments identified by the
docket ID number OPPT–2004–0053
and the specific PMN number or TME
number, must be received on or before
November 18, 2005.
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:
Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division,
Office of Pollution Prevention and
Toxics (7408M), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
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Sfmt 4703
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. As such, the Agency has not
attempted to describe the specific
entities that this action may apply to.
Although others may be affected, this
action applies directly to the submitter
of the premanufacture notices addressed
in the 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 identification (ID) number
OPPT–2004–0053. 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
EPA Docket Center, Rm. B102-Reading
Room, EPA West, 1301 Constitution
Ave., NW., Washington, DC. The EPA
Docket Center is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The EPA
Docket Center Reading Room telephone
number is (202) 566–1744 and the
telephone number for the OPPT Docket,
which is located in EPA Docket Center,
is (202) 566–0280.
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.
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. 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.
E:\FR\FM\19OCN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Notices]
[Pages 60826-60828]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20905]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0182; FRL-7727-6]
Pesticide Product Registrations; Conditional Approval
AGENCY: Environmental Protection Agency (EPA).
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:
[[Page 60827]]
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. of this
notice. 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 identification (ID) number OPP-2004-0182. 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.
In accordance with section 3(c)(2) of FIFRA, a copy of the approved
label, the list of data references, the data and other scientific
information used to support registration, except for material
specifically protected by section 10 of FIFRA, are available for public
inspection in the Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal
Mall 2, Arlington, VA (703) 305-5805. Requests for data must
be made in accordance with the provisions of the Freedom of Information
Act and must be addressed to the Freedom of Information Office (A-101),
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Such requests
should: Identify the product name and registration number and specify
the data or information desired.
A paper copy of the fact sheet, which provides more detail on this
registration, may be obtained from the National Technical Information
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.
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. 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. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Electronic versions of the MON 863 Fact Sheet and Biopesticide
Regulatory Action Document, as well as the YieldGard Plus Fact Sheet
are available at https://www.epa.gov/bioopesticides/.
II. Did EPA Conditionally Approve the Application?
A conditional registration may be granted under section 3(c)(7)(C)
of FIFRA for a new active ingredient where certain data are lacking, on
condition that such data are received by the end of the conditional
registration period and do not meet or exceed the risk criteria set
forth in 40 CFR 154.7; that use of the pesticide during the conditional
registration period will not cause unreasonable adverse effects; and
that use of the pesticide is in the public interest.
The Agency has considered the available data on the risks
associated with the proposed use of Bacillus thuringiensis Cry3Bb1
protein and the genetic material necessary for its production (Vector
ZMIR13L) in event MON 863 corn, and information on social, economic,
and environmental benefits to be derived from such use. Specifically,
the Agency has considered the nature and its pattern of use,
application methods and rates, and level and extent of potential
exposure. Based on these reviews, the Agency was able to make basic
health and safety determinations which show that use of Bacillus
thuringiensis Cry3Bb1 protein and the genetic material necessary for
its production Vector ZMIR13L in Event MON 863 corn during the period
of conditional registration will not cause any unreasonable adverse
effect on the environment, and that use of the pesticide is, in the
public interest.
Consistent with section 3(c)(7)(C) of FIFRA, the Agency has
determined that these conditional registrations are in the public
interest. Use of the pesticides are of significance to the user
community, and appropriate labeling, use directions, and other measures
have been taken to ensure that use of the pesticides will not result in
unreasonable adverse effects to man and the environment.
The Agency has considered the available data on the risks
associated with the proposed use of YieldGard Plus Bacillus
thuringiensis Cry3Bb1 protein and the genetic material necessary for
its production (Vector ZMIR13L) in Event MON 863 corn stacked with
Bacillus thuringiensis Cry1A(b) delta endotoxin and the genetic
material necessary for its production in corn via conventional
breeding, and information on social, economic, and environmental
benefits to be derived from such use.
Based on these reviews, the Agency was able to make basic
environmental, health, and safety determinations which show that use of
YieldGard Plus [Bacillus thuringiensis Cry3Bb1 protein and the genetic
material necessary for its production (Vector ZMIR13L) in Event MON 863
corn stacked with Bacillus thuringiensis Cry1A(b) delta endotoxin and
the genetic material necessary for its production in corn via
conventional breeding], consistent with the terms and conditions of
registration during the period of conditional registration, will not
significantly increase the risk of unreasonable adverse effect on the
environment.
The YieldGard Plus product is conditionally registered in
accordance with FIFRA section 3(c)(7)(B). If the conditions are not
complied with the registration will be subject to cancellation in
accordance with FIFRA section 6(e).
[[Page 60828]]
III. Conditionally Approved Registrations
EPA issued a notice, published in the Federal Register of March 13,
2002 (67 FR 11333) (FRL-6827-3), which announced that Monsanto Company,
800 N. Lindberg Blvd., St. Louis, MO 63167, had submitted an
application to conditionally register the pesticide product, Event MON
863: Corn Rootworm Protected Corn (ZMIR13L), a plant-incorporated
protectant (EPA File Symbol 524-LEI), containing Bacillus thuringiensis
Cry3Bb1 protein and the genetic material necessary for its production
(Vector ZMIR13L) in corn, an active ingredient not included in any
previously registered product.
The application was conditionally approved on February 24, 2003 for
the product listed below:
1. Event MON 863: Corn Rootworm Protected Corn (ZMIR13L) (EPA
Registration Number 524-528) for use as a plant-incorporated protectant
in corn.
EPA issued a notice, published in the Federal Register of April 2,
2003 (68 FR 16036) (FRL-7286-1), which announced that Monsanto Company,
800 N. Lindberg Blvd., St. Louis, MO 63167, had submitted an
application to conditionally register the pesticide product, YieldGard
Plus Corn, a plant-incorporated protectant (EPA File Symbol 524-LUL),
containing Bacillus thuringiensis Cry3Bb1 protein and the genetic
material necessary for its production (Vector ZMIR13L) in corn and
Bacillus thuringiensis CryBacillus thuringiensis Cry1A(b) delta
endotoxin and the genetic material necessary for its production in corn
via conventional breeding. The stacking of Bacillus thuringiensis
Cry3Bb1 protein and the genetic material necessary for its production
(Vector ZMIR13L) in corn andBacillus thuringiensis Cry1A(b) delta
endotoxin and the genetic material necessary for its production in corn
via conventional breeding resulted in a pesticide product involving a
changed use pattern for its active ingredients pursuant to the
provision of section 3(c)(4) of FIFRA.
The application was conditionally approved on October 25, 2003 for
the product listed below:
2. YieldGard Plus Corn (EPA Registration Number 524-545) for use as
a plant-incorporated protectant in corn.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: October 11, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 05-20905 Filed 10-18-05; 8:45 am]
BILLING CODE 6560-50-S
