[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Notices]
[Pages 60826-60828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20905]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0182; FRL-7727-6]


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 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:[email protected].

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 http://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 http://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 http://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