Document ID: EPA-HQ-OPP-2007-0597-0001
Agency: epa
Document Type: Notice
Title: Pesticide Product Registrations; Conditional Approval
Posted Date: 2007-08-15T04:00Z

[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