Environmental Protection Agency (EPA).
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-ØØ863-5) 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-ØØ81Ø-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-ØØ863-5), 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-ØØ81Ø-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.
The cancellations are effective September 30, 2010.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start Printed Page 52330
|EPA Registration Number||Product Name||EPA Company Number||Company Name and 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.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
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]
BILLING CODE 6560-50-S