Document ID: EPA-HQ-OPP-2010-0699-0001
Agency: epa
Document Type: Notice
Title: Product Cancellation Order for Certain Pesticide Registrations: Corn Event MON 863 and MON 863 x MON 810
Posted Date: 2010-08-25T04:00Z

[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]               
[Page 52329-52330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au10-62]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0699; FRL-8842-8]

 
Corn Event MON 863 and MON 863 x MON 810; Product Cancellation 
Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations of 
certain products containing the pesticides, Bacillus thuringiensis 
Cry3Bb1 protein and the genetic material necessary for its production 
(vector PV-ZMIR13L) in MON 863 corn (Organization for Economic 
Cooperation and Development (OECD) Unique Identifier: MON-
[Oslash][Oslash]863-5) and/or Bacillus thuringiensis Cry1Ab protein and 
the genetic material necessary for its production (vector PV-ZMCT01) in 
MON 810 corn (OECD Unique Identifier: MON-[Oslash][Oslash]81[Oslash]-
6), pursuant to section 3 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended. This cancellation order will 
follow the September 30, 2010, expiration of two conditional, time-
limited registrations that are listed in Table 1 of Unit II. These are 
the last products containing Bacillus thuringiensis Cry3Bb1 protein and 
the genetic material necessary for its production (vector PV-ZMIR13L) 
in MON 863 corn (OECD Unique Identifier: MON-[Oslash][Oslash]863-5), 
but are not the last products containing Bacillus thuringiensis Cry1Ab 
protein and the genetic material necessary for its production (vector 
PV-ZMCT01) in MON 810 corn (OECD Unique Identifier: MON-
[Oslash][Oslash]81[Oslash]-6), registered for use in the United States. 
Any distribution, sale, or use of the products subject to this 
cancellation order is permitted only in accordance with the terms of 
this order, including any existing stocks provisions.

DATES: The cancellations are effective September 30, 2010.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; fax 
number: (703) 305-0118; e-mail address: kausch.jeannine@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders including environmental, human 
health, and agricultural advocates; the chemical industry; pesticide 
users; and members of the public interested in the sale, distribution, 
or use of pesticides. Since others also may be interested, the Agency 
has not attempted to describe all the specific entities that may be 
affected by this action. 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-2010-0699. Publicly available 
docket materials are available either in the electronic docket at 
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.

II. What Action is the Agency Taking?

    This notice announces the expiration of products registered under 
FIFRA section 3. Furthermore, this notice serves as a cancellation 
order and provides terms governing the distribution, sale, and use of 
existing stocks of the affected products. These registrations are 
listed in sequence by registration number in Table 1 of this unit.

[[Page 52330]]

                    Table 1.--Product Cancellations and Registrant of the Cancelled Products
----------------------------------------------------------------------------------------------------------------
                                                                                             Company Name and
       EPA Registration Number               Product Name          EPA Company Number            Address
----------------------------------------------------------------------------------------------------------------
524-528                                Corn Event MON 863       524                      Monsanto Company, 800
                                                                                          North Lindbergh Blvd.,
                                                                                          St. Louis, MO 63167
----------------------------------------------------------------------------------------------------------------
524-545                                MON 863 x MON 810        524                      Monsanto Company, 800
                                                                                          North Lindbergh Blvd.,
                                                                                          St. Louis, MO 63167
----------------------------------------------------------------------------------------------------------------

III. Cancellation Order

    The Agency considers the expiration of a conditional, time-limited 
registration to be a cancellation under FIFRA section 3. This notice, 
therefore, serves as a cancellation order issued under FIFRA section 3 
for the product registrations identified in Table 1 of Unit II. Under 
this order, and consistent with the expiration date referenced in the 
SUMMARY, the product registrations identified in Table 1 of Unit II. 
are hereby cancelled effective September 30, 2010. After September 30, 
2010, all sales of Corn Event MON 863 and MON 863 x MON 810 seed are 
prohibited, except as described in Unit IV. regarding existing stocks. 
Any distribution, sale, or use of the products identified in Table 1 of 
Unit II. in a manner inconsistent with this order, including the 
Provisions for Disposition of Existing Stocks set forth in Unit IV., 
will be considered a violation of FIFRA section 12(a)(2)(K) and/or 
section 12(a)(1)(A).

IV. Provisions for Disposition of Existing Stocks

    Under FIFRA section 6(a)(1), EPA may permit the continued sale and 
use of existing stocks of a pesticide whose registration has been 
cancelled. For purposes of this order, ``existing stocks'' is defined, 
pursuant to EPA's existing stocks policy published in the Federal 
Register issued on June 26, 1991 (56 FR 29362), as those stocks of 
registered pesticide products which are currently in the United States 
and which were packaged, labeled, and released for shipment (defined 
under 40 CFR 152.3) prior to the effective date of the cancellation 
action. The effective date of these cancellations is September 30, 
2010. Pursuant to section 6(a)(1) of FIFRA, this cancellation order 
that is the subject of this notice includes the following existing 
stock provisions:
    1. Prior to seed shipment through July 1, 2011, Monsanto Company 
(Monsanto) and persons licensed by Monsanto to produce, use, or 
distribute MON 863-containing seed may apply seed treatment to, and 
test for germination in order to comply with Federal and State laws, 
that seed which has been sold to growers for planting by July 1, 2011.
    2. Monsanto and persons licensed by Monsanto to produce, use, or 
distribute MON 863-containing seed may sell or distribute existing 
stocks of Corn Event MON 863 and MON 863 x MON 810 seed through July 1, 
2011, for planting by July 1, 2011.
    3. Existing stocks of Corn Event MON 863 and MON 863 x MON 810 seed 
can only be planted by July 1, 2011, for the production of a corn crop.
    4. An adequate amount of refuge seed must be commercially available 
to growers to ensure the planting of appropriate corn rootworm and corn 
borer refuges that are consistent with the previously existing terms 
and conditions of the Corn Event MON 863 and MON 863 x MON 810 
registrations.
    5. Monsanto Insect Resistant Management (IRM)/Grower Guides will 
contain IRM compliance and refuge requirements that are consistent with 
IRM/Grower Guides required under the previously existing terms and 
conditions of the Corn Event MON 863 and MON 863 x MON 810 
registrations.
    6. Any remaining inventory of Corn Event MON 863 and MON 863 x MON 
810 seed that has not been sold, distributed, or used by July 1, 2011, 
will be handled in accordance with legal and regulatory requirements 
(non-treated seed can be sold as grain, and treated seed must be 
disposed of properly).
    7. Monsanto shall report the following to the Agency:
    a. Insect Resistance Management compliance communication and 
assessment will be reported via the Agricultural Biotechnology 
Stewardship Technical Committee (ABSTC) Compliance Assurance Program 
(CAP) in January 2011 for any 2010 planting and in January 2012 for any 
2011 planting.
    b. Monsanto will submit a Grower Point of Sale (GPOS) Report to EPA 
in January 2011 for any 2010 sales and in January 2012 for any 2011 
sales.
    c. Monsanto will submit a Pesticide Use Report to EPA by December 
15, 2010, and by December 15, 2011.
    d. For the Cry3Bb1 and/or Cry1Ab proteins expressed in Corn Event 
MON 863 and MON 863 x MON 810, Monsanto will submit results of 
monitoring and investigations of damage reports in August 2011 for any 
2010 planting and in August 2012 for any 2011 planting.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 19, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

[FR Doc. 2010-21137 Filed 8-24-10; 8:45 am]
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