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 (including 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 Trait 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 information (CBI) deleted version of the same 

application. 

Bayer CropScience has used conventional cotton breeding techniques to develop the 

combined trait product T304-40 x GHB119 x COT102 x COT67B that confers insect 

resistance to lepidopteran pests of cotton. The single events 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 effective 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 acetyltransferase) protein which confers 

tolerance to glufosinate-ammonium herbicides. Both events 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 completed the FDA consultation (February, 

2009) process and USDA APHIS deregulation is pending. COT102 produces the 
Vip3Aa protein from Bacillus thuringiensis which also affords protection from 

lepidopteran cotton pests. COT102 was reviewed 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 FLCry1Ab) 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 protein has been reviewed and a temporary 

exemption from the requirement of a tolerance (§ 174.530) has been granted through 

December 31, 2011. 

An application for an EUP to test the combined trait cotton T304-40 x GHB119 x 

COT102 x COT67B, along with the individual 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 commonwealth of Puerto 

Rico is requested. These trials 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 proposed 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 the administrative volume. 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. granting permission to Bayer CropScience to 

cite certain submissions/data is also enclosed. 

The documents accompanying this application are 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”) documents 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 enclosed 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 Manager 
Contents 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)