[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Notices]
[Page 45807-45808]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-82]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0597; FRL-8141-6]
Pesticide Product Registrations; Conditional Approval
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces Agency approval of applications
submitted by Syngenta Seeds, Monsanto Company, Pioneer Hi-Bred
International (A Dupont Company), and Mycogen Seeds (c/o Dow
AgroSciences), to conditionally register the pesticide products
Agrisure\TM\ RW Rootworm-Protected Corn, MON 88017, MON 88017 x MON
810, Herculex Rootworm Insect Protection, and Herculex RW Insect
Protection, containing new active ingredients 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 (7511P), 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:
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. 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 a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0597. Publicly
available docket materials are available either in the electronic
[[Page 45808]]
http://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.
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 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 Biopesticide Regulatory
Action Documents are available at http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm
.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
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 Modified Cry3A protein and the genetic material necessary for
its production (via elements of pZM26) in event MIR604 corn SYN-IR604-
8, Bacillus thuringiensis Cry3Bb1 protein and the genetic material
necessary for its production (Vector ZMIR39) in Event MON 88017 corn
(OECD Unique Identifier: MON-88O17-3), and Bacillus thuringiensis
Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for
their production (plasmid insert PHP 17662) in Event DAS-59122-7 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 Modified Cry3A protein and the genetic material necessary for
its production (via elements of pZM26) in event MIR604 corn SYN-IR604-
8, Bacillus thuringiensis Cry3Bb1 protein and the genetic material
necessary for its production (Vector ZMIR39) in Event MON 88017 corn
(OECD Unique Identifier: MON-88O17-3), and Bacillus thuringiensis
Cry34Ab1 and Cry35Ab1 proteins and the genetic material necessary for
their production (plasmid insert PHP 17662) in Event DAS-59122-7 corn
during the period of conditional registrations will not cause any
unreasonable adverse effect on the environment, and that use of the
pesticides are, 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.
III. Conditional Approval Form
EPA issued a notice, published in the Federal Register of October
27, 2004 (69 FR 62678) (FRL-7370-4), which announced that Syngenta
Seeds, Inc., Field Crops-NAFTA, P.O. Box 12257, 3054 Cornwallis Rd.,
Research Triangle Park, NC 27709-2257, had submitted an application to
conditionally register the pesticide product, Event MIR604 Rootworm-
Protected Corn, Plant-Incorporated Protectant (EPA File Symbol 67979-
L), containing Modified Cry3A protein and the genetic material
necessary for its production (via elements of pZM26) in event MIR604
corn SYN-IR604-8 an active ingredient not included in any previously
registered product. The application was approved on October 3, 2006, as
Agrisure\TM\ RW Rootworm Protected Corn, (EPA Registration Number
67979-5). This product is a plant-incorporated protectant.
EPA also issued a notice, published in the Federal Register of
December 22, 2004 (69 FR 76716) (FRL-7370-5), which announced that
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, had
submitted an application to conditionally register the pesticide
products, MON 88017 and MON 88017 x MON 810, Plant-Incorporated
Protectant EPA File Symbols 524-LLR and 524-LLE), containing [Bacillus
thuringiensis Cry3Bb1 protein and the genetic material necessary for
its production (Vector ZMIR39) in Event MON 88017 corn (OECD Unique
Identifier: MON-88O17-3) an active ingredient not included in any
previously registered product.The applications were approved on
December 13, 2005, as MON 88017, (EPA Registration Number 524-551) and
MON 88017 x MON 810, (EPA Registration Number 524-552). These products
are plant-incorporated protectants.
EPA also issued a notice, published in the Federal Register of
September 1, 2004 (69 FR 53434) (FRL-7370-2), which announced that
Pioneer Hi-Bred International, A Dupont Company, 7250 N.W. 62nd Ave.,
P.O. Box 552, Johnston, IA 50131-0552 and Mycogen Seeds c/o Dow
AgroSciences , had submitted an application to conditionally register
the pesticide products, Pioneer Brand B.t. Cry34/35Ab1 Insect Resistant
Corn Seed and Mycogen Brand B.t. Cry34/35Ab1 Construct 17662 Corn,
Plant-Incorporated Protectants (EPA File Symbols 29964-U and 68467-L),
containing Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins and
the genetic material necessary for their production (plasmid insert PHP
17662) in Event DAS-59122-7 corn an active ingredient not included in
any previously registered product.The applications were approved on
August 31, 2005 , as Herculex Rootworm Insect Protection, (EPA
Registration Number 29964-4) and Herculex RW Insect Protection, (EPA
Registration Number 68467-5). These products are plant-incorporated
protectants.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: August 2, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E7-16049 Filed 8-14-07; 8:45 am]
BILLING CODE 6560-50-S