March 21, 2011

Document Processing Desk Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501

Attn: Dr. Sheryl Reilly

Subject: Application for an Experimental Use Permit to Test Combined Trait Cotton T304-40 x GHB119 x COT102 x COT67B, and the Combined Trait Cotton Necessary for their Production, Along with T304-40, GHB119, COT102, COT67B (EPA File Symbol 264-EUP-X)

Dear Dr. Reilly,

Please find enclosed five copies (inc luding two courtesy copies) of the Application for an Experimental Use Permit to Test Combined Trait Cotton T304-40 x GHB119 x COT102 x COT67B, and the Combined Trai t Cotton Necessary for their Production, Along with T304-40, GHB119, COT102, COT67B (EPA File Symbol 264-EUP-X) and three copies of the confidential business info rmation (CBI) deleted version of the same application.

Bayer CropScience has used c onventional cotton breeding techniques to develop the combined trait product T304-40 x GHB119 x CO T102 x COT67B that confers insect resistance to lepidopteran pe sts of cotton. The single even ts of the combination each contribute specific benefits to the combined event product. Event T304-40 produces the Bacillus thuringiensis subsp Berliner Cry1Ab protein that is e ffective in controlling lepidopteran larvae such as the cotton bollworm (CBW) and tobacco budworm (TBW). Event GHB119 produces the Bacillus thuringiensis subsp dakota Cry2Ae protein that is effective in controlling cotton pests such as CBW, TBW and fall armyworm (FAW). COT67B also produces the Bacillus thuringiensis Cry1Ab protein (referred to as fulllength FLCry1Ab in the application). Both T304-40 and GHB119 contain the bar gene which expresses the PAT (phosphinothricin ac etyltransferase) protein which confers tolerance to glufosinate-amm onium herbicides. Both even ts are currently under review as part of the submissions for T304-40 x GHB119 at FDA, USDA APHIS and EPA. COT67B was reviewed as part of COT102 x COT67B product which was registered by EPA (67979-9) in June, 2008. COT67B has co mpleted the FDA consultation (February, 2009) process and USDA APHIS deregula tion is pending. COT102 produces theVip3Aa protein from Bacillus thuringiensis which also affords protection from lepidopteran cotton pests. COT102 was revi ewed as part of the COT102 x COT67B product which was registered by EPA (June, 2008) and has completed FDA consultation (July, 2005) and was deregulated by USDA APHIS (July, 2005).

The safety of the Cry1Ab (Cry1Ab and FL Cry1Ab) and Vip3Aa proteins has been demonstrated and they are exempt from the requirement of a tolerance ((§174.510, §174.501). The safety of the Cry2Ae protei n has been reviewed and a temporary exemption from the requirement of a tole rance (§ 174.530) has been granted through December 31, 2011.

An application for an EUP to test th e combined trait cotton T304-40 x GHB119 x COT102 x COT67B, along with the indivi dual traits, T304-40, GHB119, COT67B, COT102, and the sub-combinations is enclosed with this letter. Approval to plant 24420 lbs cotton seed (0.55 lbs a.i.) on 2035 acres in 12 states and the co mmonwealth of Puerto Rico is requested. These tr ials will provide information from breeding and introgression studies, yield trials, herbicide tolerance trials , insect efficacy trials, insect resistance management trials, and regulatory studies.

Bayer CropScience requests that the propos ed EUP be granted from October 1, 2011 through June 1, 2013.

A list of participants who will supervise the experimental work is included in a

confidential attachment to th e administrative volu me. A list of cooperators involved in the EUP program and counties where the trials will be planted will be provided to the Agency well in advance of planting.

A letter from Syngenta Biotechnology Inc. gr anting permission to Bayer CropScience to

cite certain submissions/data is also enclosed.

The documents accompanying this application ar e listed below. Each document has been classified for its confidentiality (A, B or C) as defined by the Agency. A CD-ROM containing the fully releasable (“A”) docum ents in .pdf format is also provided.

Copies of the letter for fee remittance and the check for the amount of $86,823 (EPA PRIA fee code: B740) are en closed with this letter.

Should you require any additional information, please feel free to contact me by phone at (919) 549-2599 or e-mail at isabelle.coats@bayer.com.

Regards,

Isabelle Coats U.S. Registration ManagerContents of the Submission

Vol.

Number/Classification Contents MRID

A Cover Letter (This letter) w/ Enclosure: Complimentary copies of the PRIA

letter for fee remittance and Check # 3200041335 in the amount of $86,823 for PRIA Fee B740

Volume 1 Administrative Volume

A Transmittal Document entitled “Application for an Experimental Use Permit 264-EUP-X

A Transmittal Document entitled “Application for an Experimental Use Permit 264-EUP-X (CBI deleted)

A Application for Pesticide, EPA Form 8570-1

, dated March 21, 2011

A Certification with Respect to Data Citation, EPA

Form 8570-34 , dated March 21, 2011

C Confidential Statement of Formula, T304-40 x GHB119 x COT102 x COT67B (Cotton producing the Cry1Ab, Cry2Ae, Vip3Aa, and FLCry1Ab insecticidal proteins from Bacillus thuringiensis

, and marker substances) (dated March 21, 2011) (2 Pages)

C Confidential Statement of Formula for T304-40 x GHB119 (Cotton producing the Cry1Ab and Cry2Ae insecticidal proteins from Bacillus thuringiensis (Bt) and marker substance) (dated September 25, 2009) (3 Pages)

C Confidential Statement of Formula for T304-40 (Cotton producing the Cry1Ab insecticidal protein

from Bacillus thuringiensis (Bt) and marker substance) (dated September 25, 2009)(4 Pages)

C Confidential Statement of Formula for GHB119 (Cotton producing the Cry2Ae insecticidal protein

from Bacillus thuringiensis (Bt) and marker substance) (dated September 25, 2009) (4 pages)

C List of Participants

C Data Matrix for T304-40 x GHB119 x COT102 x COT67B, EPA Form 8570-4 , (Agency Copy) (1 page)

A Data Matrix for T304-40 x GHB119 x COT102 x COT67B, EPA Form 8570-4 , (Public Copy) (1 page)

Volume 2

B Cry1Ab, Cry2Ae, PAT/ bar , FLCry1Ab, Vip3Aa,

APH4 levels in selected tissues of the combined trait product T304-40 x GHB119 x COT102 x COT67B (BCS- GHØØ4-7 x BCS- GHØØ5-8 x SYN-IR1Ø2-7 x SYN-IRØ67-1)