[Federal Register: October 19, 2005 (Volume 70, Number 201)]
[Notices]
[Page 60826-60828]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc05-73]
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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: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 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