Pesticide Product Registrations; Conditional Approvals, 35805-35807 [2010-15207]
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Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
0.05 ppm. Contact: Laura Nollen, (703)
305–7390, e-mail address:
nollen.laura@epa.gov.
2. PP 9F7622. (EPA–HQ–OPP–2010–
0287). Valent U.S.A. Company, 1600
Riviera Ave., Suite 200, Walnut Creek,
CA 94596–8025, proposes to amend the
tolerance in 40 CFR 180.617 by
decreasing the established tolerance for
residues of the fungicide metconazole,
5-[(4-chlorophenyl)methyl]-2,2dimethyl-1-(1H-1,2,4-triazol-1ylmethyl)cyclopentanol, measured as
the sum of cis- and trans- isomers, in or
on nut, tree (crop group 14) from 0.04
ppm to 0.02 ppm. Independently
validated analytical methods have been
submitted for analyzing parent
metconazole residues with appropriate
sensitivity for all canola crop and
processed commodities for which a
tolerance is being requested. Contact:
Tracy Keigwin, (703) 305–6605, e-mail
address: keigwin.tracy@epa.gov.
3. PP 9F7678. (EPA–HQ–OPP–2010–
0268). Bayer CropScience LLC, 2 T. W.
Alexander Drive, Research Triangle
Park, NC 27709, proposes to amend the
40 CFR 180.324 by revising tolerances
for residues of the herbicide,
bromoxynil including its metabolites
and degradates. Compliance with the
tolerance levels specified is to be
determined by measuring residues of
bromoxynil (3,5-dibromo-4hydroxybenzonitrile), in or on sorghum,
grain at 0.2 ppm; grass, hay at 5.0 ppm;
and grass, forage at 18 ppm. Since
bromoxynil already has tolerances on
sorghum and grass commodities
adequate analytical methods are in
place to support the desired uses.
Contact: Bethany Benbow, (703) 347–
8072, e-mail address:
benbow.bethany@epa.gov.
4. PP 9F7680. (EPA–HQ–OPP–2010–
0266). Bayer CropScience LLC, 2 T. W.
Alexander Drive, Research Triangle
Park, NC 27709, proposes to increase
the tolerances in 40 CFR 180.631 for
residues of the herbicide, pyrasulfotole
including its metabolites and
degradates. Compliance with the
tolerance levels specified is to be
determined by measuring residues of
pyrasulfotole (AE0317309) (5-hydroxy1,3-dimethyl-1H-pyrazol-4-yl)[2(methylsulfonyl)-4(trifluoromethyl)phenyl]-methanone
and its metabolite (5-Hydroxy-3-methyl1H-pyrazol-4-yl-[2-(methylsulfonyl)-4(trifluoromethyl)phenyl] methanone,
calculated as the stoichiometric
equivalent of pyrasulfotole, in or on
cattle, goat, hog, sheep, horse, meat at
0.04 ppm; cattle, goat, hog, sheep, horse,
fat at 0.04 ppm; cattle, goat, hog, sheep,
horse, meat byproducts, except liver at
2 ppm; and cattle, goat, hog, sheep,
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horse, liver at 8 ppm. The analytical
method is an LC/MS/MS method which
quantifies pyrasulfotole and its
metabolite (5-Hydroxy-3-methyl-1Hpyrazol-4-yl)[2-(methylsulfonyl)-4(trifluoromethyl) phenyl]methanone
with an LOQ of 0.01 mg/kg.
Pyrasulfotole and its metabolite are
solvent extracted, hydrolyzed to
released conjugated residues and
purified by C18 solid phase extraction.
Residues are quantified by LC/MS/MS
using isotopically labeled internal
standards. Validation of the
methodology for the determination of
pyrasulfotole and its metabolite
demonstrated that it could accurately
determine residues at the LOQ of 0.01
ppm in all appropriate matrices.
Pyrasulfotole and its metabolite are
stable for at least 11 months for the
above matrices. Contact: Bethany
Benbow, (703) 347–8072, e-mail
address: benbow.bethany@epa.gov.
New Tolerance Exemptions
1. PP 0E7701. (EPA–HQ–OPP–2008–
0095). Ag-Chem Consulting, 12208
Quinque Lane, Clifton, VA 21024, on
behalf of LG Life Science, 910 Sylvan
Ave., Englewood Cliffs, NJ 07632,
proposes to establish an exemption from
the requirement of a tolerance for
residues of polyoxyethylene mono
(tristyrylphenyl)ether (CAS No. 99734–
09–5) applied to postharvest crops
under 40 CFR 180.910 when used as a
pesticide inert ingredient as a surfactant
with a maximum of 10.0% by weight in
pesticide formulations applied to food
areas and food contact surfaces in food
service and food handling
establishments. The petitioner believes
no analytical method is needed because
requirements for an analytical method
are not applicable to a request to
establish an exemption from the
requirement of a tolerance. Contact:
Karen Samek, (703) 347–8825, e–mail
address: samek.karen@epa.gov.
2. PP 9E7660. (EPA–HQ–OPP–2010–
0429). BASF Corporation, 100 Campus
Dr., Florham Park, NJ 07932, proposes
to establish an exemption from the
requirement of a tolerance for residues
of Acetic acid ethenyl, polymer with
oxirane (CAS No. 25820–49–9) when
used as a pesticide inert ingredient as a
surfactant in pesticide formulations
without limitation. The petitioner
believes no analytical method is needed
because requirements for an analytical
method are not applicable to a request
to establish an exemption from the
requirement of a tolerance. Contact:
Deirdre Sunderland, (703) 603–0851, e–
mail address:
sunderland.deirdre@epa.gov.
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35805
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 15, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. 2010–15034 Filed 6–22–10; 8:45 am]
BILLING CODE S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0208; FRL–8831–5]
Pesticide Product Registrations;
Conditional Approvals
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This notice announces the
Agency’s issuance, pursuant to the
provisions of section 3(c)(7)(C) of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), of conditional
registrations for the pesticide products,
MON 89034 and MON 89034 x MON
88017, containing active ingredients
that were not in any registered pesticide
products at the time of their respective
submissions.
FOR FURTHER INFORMATION CONTACT:
Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8077; e-mail address:
cerrelli.susanne@epa.gov.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\23JNN1.SGM
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35806
Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Notices
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. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
mstockstill on DSKH9S0YB1PROD with NOTICES
B. How Can I Get Copies of this
Document and Other Related
Information?
EPA has established a docket for this
action under docket identification (ID)
number EPA–HQ–OPP–2007–0208.
Publicly available docket materials are
available either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
Pursuant to section 3(c)(2) of FIFRA,
a copy of the approved labels, the list
of data references, and data or other
scientific information used to support
these registrations, except for material
specifically protected by section 10 of
FIFRA, are also available for public
inspection. 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.
Electronic versions of the fact sheets
and Biopesticides Registration Action
Documents are available at https://
www.epa.gov/oppbppd1/biopesticides/
pips/pip_list.htm.
II. Description of New Active
Ingredients
EPA received applications from
Monsanto Company, 800 North
Lindbergh Boulevard, St. Louis, MO
63167, to register pesticide products
(EPA File Symbols 524–LTL and 524–
LTA) containing the active ingredients,
Bacillus thuringiensis Cry1A.105 and
Cry2Ab2 proteins and the genetic
material necessary for their production
(vector PV-ZMIR245) in event MON
89034 corn (Office of Economic
Cooperation and Development (OECD))
Unique Identifier: MON–89034–3). At
the time of submission of the
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applications for registration, these active
ingredients were not contained in any
pesticide products registered with the
Agency.
III. Regulatory Conclusions
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 applications were approved on
June 10, 2008 for MON 89034 (EPA
Registration Number 524–575) and
MON 89034 x MON 88017 (EPA
Registration Number 524–576), both for
use on corn. The Agency approved the
applications after considering data on
risks associated with the proposed use
of the Bacillus thuringiensis Cry1A.105
and Cry2Ab2 proteins and the genetic
material necessary for their production
(vector PV-ZMIR245) in event MON
89034 corn (OECD Unique Identifier:
MON–89034–3), and information on
social, economic, and environmental
benefits to be derived from such use.
Specifically, the Agency has considered
the nature of the plant-incorporated
protectants and their 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
the Bacillus thuringiensis Cry1A.105
and Cry2Ab2 proteins and the genetic
material necessary for their production
(vector PV-ZMIR 245) in event MON
89034 corn (OECD Unique Identifier:
MON–89034–3) during the period of
conditional registration will not cause
any unreasonable adverse effect on the
environment, and that use of the
pesticides 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.
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IV. Missing Data and Conditions for
Submission
A. MON 89034
The following data/information must
be submitted to the Agency to support
the registration of MON 89034:
1. Insect Resistance Management:
Simulation modeling, which addresses
the cross-resistance of Cry1A.105,
Cry1Fa, and Cry1Ac in the cottongrowing landscape and how such crossresistance may impact the durability of
MON 89034, must be submitted by
April 1, 2009 (protocol due by August
1, 2008).
2. Insect Resistance Management: A
copy of the MON 89034 grower
agreement and associated stewardship
documents must be submitted within 90
days of the date of registration.
3. Insect Resistance Management: A
written description of a system, which
assures that growers will sign grower
agreements and persons purchasing
MON 89034 will annually affirm that
they are contractually bound to comply
with the requirements of the insect
resistance management program, must
be submitted by August 1, 2008.
4. Insect Resistance Management: A
description of the compliance assurance
program for MON 89034 must be
submitted within 90 days of the date of
registration.
5. Insect Resistance Management:
Annual reports, which focus specifically
on annual sales, grower agreements,
grower education, compliance assurance
program activities, and compliance
survey results for MON 89034, must be
submitted by January 31st of each year,
beginning in 2010.
6. Insect Resistance Management: An
annual report, summarizing insect
resistance monitoring results for MON
89034, must be submitted by August
31st of each year, beginning in 2010.
B. MON 89034 x MON 88017
The following data/information must
be submitted to the Agency to support
the registration of MON 89034 x MON
88017:
1. Insect Resistance Management: A
copy of the MON 89034 x MON 88017
grower agreement and associated
stewardship documents must be
submitted within 90 days of the date of
registration.
2. Insect Resistance Management: A
written description of a system, which
assures that growers will sign grower
agreements and persons purchasing
MON 89034 x MON 88017 will annually
affirm that they are contractually bound
to comply with the requirements of the
insect resistance management program,
must be submitted by August 1, 2008.
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3. Insect Resistance Management: A
description of the compliance assurance
program for MON 89034 x MON 88017
must be submitted within 90 days of the
date of registration.
4. Insect Resistance Management: A
revised Cry3Bb1 monitoring plan,
incorporating MON 89034 x MON
88017, must be submitted within 90
days of the date of registration.
5. Insect Resistance Management: For
the Cry3Bb1 portion of the product, a
discriminating or diagnostic dose assay
must be developed, validated, and
submitted by January 31, 2010.
6. Insect Resistance Management: For
the Cry3Bb1 portion of the product,
rootworm damage guidelines must be
finalized and submitted by January 31,
2010.
7. Insect Resistance Management:
Annual reports, which focus specifically
on annual sales, grower agreements,
grower education, compliance assurance
program activities, and compliance
survey results for MON 89034 x MON
88017 must be submitted by January
31st of each year, beginning in 2010.
8. Insect Resistance Management: An
annual report, summarizing insect
resistance monitoring results for MON
89034 x MON 88017, must be submitted
by August 31st of each year, beginning
in 2010.
4. Insect Resistance Management:
Baseline susceptibility studies and/or a
discriminating concentration assay for
the Cry1A.105 protein againstEuropean
corn borer, southwestern corn borer,
and corn earworm and for the Cry2Ab2
protein against southwestern corn borer
and corn earworm must be submitted by
April 1, 2009.
5. Insect Resistance Management: To
support sweet corn uses, baseline
susceptibility studies must be
conducted on fall armyworm
populations collected from sweet corngrowing areas and submitted by April 1,
2010.
V. Response to Comments
EPA published a notice of receipt in
the Federal Register of July 25, 2007 (72
FR 40876) (FRL–8129–7), which
announced that Monsanto Company had
submitted applications to register
pesticide products containing the new
active ingredients, Bacillus
thuringiensis Cry1A.105 and Cry2Ab2
proteins and the genetic material
necessary for their production (vector
PV-ZMIR245) in event MON 89034 corn
(OECD Unique Identifier: MON–89034–
3), for use on corn. Eight comments
were received in response to the notice
of receipt. One comment opposed
granting Monsanto Company rights to
produce, sell, or manufacture pesticide
C. MON 89034 and MON 89034 x MON
products containing the aforementioned
88017
active ingredients, but no scientific
The following data/information must
basis was provided to support this
be submitted to the Agency to support
position. In general, the other seven
the registrations of both MON 89034
comments expressed support for the
and MON 89034 x MON 88017:
applications from Monsanto Company.
1. Residue Analytical Method (Plants): Ultimately, none of the eight comments
An independent laboratory validation of affected the Agency’s review or
the analytical method for the detection
consideration of the applications, or the
of Cry2Ab2 and/or Cry1A.105 must be
conclusions the Agency arrived at as a
submitted by April 1, 2009.
result of such review and consideration.
2. Aquatic Invertebrate Acute Toxicity Pursuant to its authority under FIFRA,
Testing (Freshwater Daphnids): A 7 - to
the Agency conducted a rigorous and
14–day Daphnia study must be
comprehensive assessment of the new
performed (as per the 885 Office of
active ingredients, along with their
Chemical Safety and Pollution
associated pesticide products, and
Prevention (OCSPP) Harmonized
concluded that use of the pesticides
Guidelines)) and submitted by April 1,
during the conditional registration
2009. Alternatively, a dietary study of
period will not cause unreasonable
the effects on an aquatic invertebrate,
adverse effects to human health or the
representing the functional group of a
environment and that use of the
leaf shredder in headwater streams, can pesticides is in the public interest.
be performed and submitted in lieu of
List of Subjects
the Daphnia study.
3. Insect Resistance Management:
Environmental protection, Chemicals,
Additional information on crossPests and pesticides.
resistance of Cry1A.105, Cry1Fa, and
Dated: June 15, 2010.
Cry1Ac (preferably including binding
W. Michael McDavit,
site models and use of resistant
Acting Director, Biopesticides and Pollution
colonies) for the target pests and how
Prevention Division, Office of Pesticide
such cross-resistance may impact the
Programs.
durability of MON 89034 must be
[FR Doc. 2010–15207 Filed 6–22–10; 8:45 am]
submitted by April 1, 2009 (protocol
due by August 1, 2008).
BILLING CODE 6560–50–S
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35807
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2009–0639; FRL–8829–3]
2-(Hydroxymethyl)-2-nitro-1,3propanediol (Tris Nitro); Notice of
Receipt of Request to Voluntarily
Amend Registrations to Terminate
Certain Uses
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: In accordance with section
6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), as amended, EPA is issuing a
notice of receipt of a request by the
registrant to voluntarily amend its
2(hydroxymethyl)-2-nitro-1,3propanediol (tris nitro) product
registrations to terminate or delete one
or more uses. The request would delete
2(hydroxymethyl)-2-nitro-1,3propanediol (tris nitro) use in or on
metalworking fluids; latex paints; resin/
latex/polymer emulsions; specialty
industrial products; livestock and
poultry premises; paints, emulsions and
thickener solutions; use as a
preservative for packaged emulsions,
solutions, or suspensions such as
detergents and polishes containing
water; use in pulp and paper-mill
process water systems. The request
would not terminate the last
2(hydroxymethyl)-2-nitro-1,3propanediol (tris nitro) products
registered for use in the United States.
EPA intends to grant this request at the
close of the comment period for this
announcement unless the Agency
receives substantive comments within
the comment period that would merit its
further review of the request, or unless
the registrant withdraws its request. If
this request is granted, any sale,
distribution, or use of products listed in
this notice will be permitted after the
uses are deleted only if such sale,
distribution, or use is consistent with
the terms as described in the final order.
DATES: Comments must be received on
or before July 23, 2010.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2009–0639, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
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]]>Agencies
[Federal Register Volume 75, Number 120 (Wednesday, June 23, 2010)]
[Notices]
[Pages 35805-35807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15207]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0208; FRL-8831-5]
Pesticide Product Registrations; Conditional Approvals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the Agency's issuance, pursuant to the
provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), of conditional registrations for the
pesticide products, MON 89034 and MON 89034 x MON 88017, containing
active ingredients that were not in any registered pesticide products
at the time of their respective submissions.
FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8077; e-mail
address: cerrelli.susanne@epa.gov.
SUPPLEMENTARY INFORMATION:
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
[[Page 35806]]
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. 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?
EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0208. Publicly available
docket materials are available either in the electronic docket at
https://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
Pursuant to section 3(c)(2) of FIFRA, a copy of the approved
labels, the list of data references, and data or other scientific
information used to support these registrations, except for material
specifically protected by section 10 of FIFRA, are also available for
public inspection. 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.
Electronic versions of the fact sheets and Biopesticides
Registration Action Documents are available at https://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm.
II. Description of New Active Ingredients
EPA received applications from Monsanto Company, 800 North
Lindbergh Boulevard, St. Louis, MO 63167, to register pesticide
products (EPA File Symbols 524-LTL and 524-LTA) containing the active
ingredients, Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and
the genetic material necessary for their production (vector PV-ZMIR245)
in event MON 89034 corn (Office of Economic Cooperation and Development
(OECD)) Unique Identifier: MON-89034-3). At the time of submission of
the applications for registration, these active ingredients were not
contained in any pesticide products registered with the Agency.
III. Regulatory Conclusions
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 applications were approved on June 10, 2008 for MON 89034 (EPA
Registration Number 524-575) and MON 89034 x MON 88017 (EPA
Registration Number 524-576), both for use on corn. The Agency approved
the applications after considering data on risks associated with the
proposed use of the Bacillus thuringiensis Cry1A.105 and Cry2Ab2
proteins and the genetic material necessary for their production
(vector PV-ZMIR245) in event MON 89034 corn (OECD Unique Identifier:
MON-89034-3), and information on social, economic, and environmental
benefits to be derived from such use. Specifically, the Agency has
considered the nature of the plant-incorporated protectants and their
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 the
Bacillus thuringiensis Cry1A.105 and Cry2Ab2 proteins and the genetic
material necessary for their production (vector PV-ZMIR 245) in event
MON 89034 corn (OECD Unique Identifier: MON-89034-3) during the period
of conditional registration will not cause any unreasonable adverse
effect on the environment, and that use of the pesticides 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.
IV. Missing Data and Conditions for Submission
A. MON 89034
The following data/information must be submitted to the Agency to
support the registration of MON 89034:
1. Insect Resistance Management: Simulation modeling, which
addresses the cross-resistance of Cry1A.105, Cry1Fa, and Cry1Ac in the
cotton-growing landscape and how such cross-resistance may impact the
durability of MON 89034, must be submitted by April 1, 2009 (protocol
due by August 1, 2008).
2. Insect Resistance Management: A copy of the MON 89034 grower
agreement and associated stewardship documents must be submitted within
90 days of the date of registration.
3. Insect Resistance Management: A written description of a system,
which assures that growers will sign grower agreements and persons
purchasing MON 89034 will annually affirm that they are contractually
bound to comply with the requirements of the insect resistance
management program, must be submitted by August 1, 2008.
4. Insect Resistance Management: A description of the compliance
assurance program for MON 89034 must be submitted within 90 days of the
date of registration.
5. Insect Resistance Management: Annual reports, which focus
specifically on annual sales, grower agreements, grower education,
compliance assurance program activities, and compliance survey results
for MON 89034, must be submitted by January 31st of each year,
beginning in 2010.
6. Insect Resistance Management: An annual report, summarizing
insect resistance monitoring results for MON 89034, must be submitted
by August 31st of each year, beginning in 2010.
B. MON 89034 x MON 88017
The following data/information must be submitted to the Agency to
support the registration of MON 89034 x MON 88017:
1. Insect Resistance Management: A copy of the MON 89034 x MON
88017 grower agreement and associated stewardship documents must be
submitted within 90 days of the date of registration.
2. Insect Resistance Management: A written description of a system,
which assures that growers will sign grower agreements and persons
purchasing MON 89034 x MON 88017 will annually affirm that they are
contractually bound to comply with the requirements of the insect
resistance management program, must be submitted by August 1, 2008.
[[Page 35807]]
3. Insect Resistance Management: A description of the compliance
assurance program for MON 89034 x MON 88017 must be submitted within 90
days of the date of registration.
4. Insect Resistance Management: A revised Cry3Bb1 monitoring plan,
incorporating MON 89034 x MON 88017, must be submitted within 90 days
of the date of registration.
5. Insect Resistance Management: For the Cry3Bb1 portion of the
product, a discriminating or diagnostic dose assay must be developed,
validated, and submitted by January 31, 2010.
6. Insect Resistance Management: For the Cry3Bb1 portion of the
product, rootworm damage guidelines must be finalized and submitted by
January 31, 2010.
7. Insect Resistance Management: Annual reports, which focus
specifically on annual sales, grower agreements, grower education,
compliance assurance program activities, and compliance survey results
for MON 89034 x MON 88017 must be submitted by January 31st of each
year, beginning in 2010.
8. Insect Resistance Management: An annual report, summarizing
insect resistance monitoring results for MON 89034 x MON 88017, must be
submitted by August 31st of each year, beginning in 2010.
C. MON 89034 and MON 89034 x MON 88017
The following data/information must be submitted to the Agency to
support the registrations of both MON 89034 and MON 89034 x MON 88017:
1. Residue Analytical Method (Plants): An independent laboratory
validation of the analytical method for the detection of Cry2Ab2 and/or
Cry1A.105 must be submitted by April 1, 2009.
2. Aquatic Invertebrate Acute Toxicity Testing (Freshwater
Daphnids): A 7 - to 14-day Daphnia study must be performed (as per the
885 Office of Chemical Safety and Pollution Prevention (OCSPP)
Harmonized Guidelines)) and submitted by April 1, 2009. Alternatively,
a dietary study of the effects on an aquatic invertebrate, representing
the functional group of a leaf shredder in headwater streams, can be
performed and submitted in lieu of the Daphnia study.
3. Insect Resistance Management: Additional information on cross-
resistance of Cry1A.105, Cry1Fa, and Cry1Ac (preferably including
binding site models and use of resistant colonies) for the target pests
and how such cross-resistance may impact the durability of MON 89034
must be submitted by April 1, 2009 (protocol due by August 1, 2008).
4. Insect Resistance Management: Baseline susceptibility studies
and/or a discriminating concentration assay for the Cry1A.105 protein
againstEuropean corn borer, southwestern corn borer, and corn earworm
and for the Cry2Ab2 protein against southwestern corn borer and corn
earworm must be submitted by April 1, 2009.
5. Insect Resistance Management: To support sweet corn uses,
baseline susceptibility studies must be conducted on fall armyworm
populations collected from sweet corn-growing areas and submitted by
April 1, 2010.
V. Response to Comments
EPA published a notice of receipt in the Federal Register of July
25, 2007 (72 FR 40876) (FRL-8129-7), which announced that Monsanto
Company had submitted applications to register pesticide products
containing the new active ingredients, Bacillus thuringiensis Cry1A.105
and Cry2Ab2 proteins and the genetic material necessary for their
production (vector PV-ZMIR245) in event MON 89034 corn (OECD Unique
Identifier: MON-89034-3), for use on corn. Eight comments were received
in response to the notice of receipt. One comment opposed granting
Monsanto Company rights to produce, sell, or manufacture pesticide
products containing the aforementioned active ingredients, but no
scientific basis was provided to support this position. In general, the
other seven comments expressed support for the applications from
Monsanto Company. Ultimately, none of the eight comments affected the
Agency's review or consideration of the applications, or the
conclusions the Agency arrived at as a result of such review and
consideration. Pursuant to its authority under FIFRA, the Agency
conducted a rigorous and comprehensive assessment of the new active
ingredients, along with their associated pesticide products, and
concluded that use of the pesticides during the conditional
registration period will not cause unreasonable adverse effects to
human health or the environment and that use of the pesticides is in
the public interest.
List of Subjects
Environmental protection, Chemicals, Pests and pesticides.
Dated: June 15, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2010-15207 Filed 6-22-10; 8:45 am]
BILLING CODE 6560-50-S
