Dennis P. Ward, Ph.D. Syngenta Biotechnology, Inc.

Tel. 1.919.226.7382 3054 E. Cornwallis Road

Fax 1.919.226.7462 P.O. Box 12257 dennis.ward@syngenta.com Research Triangle Park

North Carolina 27709 USA

5307

- EPA

- 12 

### March 31 , 2011

U.S. Environmental Protection Agency Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) Room S4900, One Potomac Yard 2777 Crystal Drive Arlington, VA 22202

Attn: Sheryl K. Reilly, Ph.D., Chief Biopesticides and Pollution Prevention Division

Subject: A pplication for registration of 5307 Corn, a manufacturing

- use product containing an the eCry3.1Ab protein plant

- in corporated protectant

Dear Dr. Reilly:

P lease find enclosed Syngenta’s application for registration of a manufacturing

- use product, 5307

Corn that contains the Bacillus thuringiensis

- derived insecticidal protein, eCry3.1Ab. Corn lines containing this eCry3.1Ab are protected from root feeding damage caused by corn rootworms ( Diabrotica sp.). An experimental use permit ( 67979

- EUP

- 8 ) has been issued for field testing of

5307 Corn and a temporary exemption from the requirement of a tolerance has been established for eCry3.1Ab re sidues in corn (40 CFR §174.532).

The proposed PRIA category for this action is B8 0 0 and the fee has been paid. A copy of Syngenta’s check is attached as Certification of Payment. This application is accompanied by a petition to co n vert the temporary tol e rance exemption for eCry3.1Ab in corn to nonexpiring status.

Please note t hat Syngenta is simultaneously applying for registrations of two end

- use products containing the 5307 Corn transformatio n event in breeding combination with other registered plant

- incorporated protectants

. 1. Bt11xMIR604xTC1507x5307 Corn

2. Bt11xMIR162xMIR604xTC1507x5307 Corn These applications should be assigned to PRIA category B880. These three applications should be

linked for PRIA fee and timelin e purposes.

Included in this submission are the following materials:

- Certification of paymentDr. S. Reilly March 31, 2011 Page

- 2

-

5307

- EPA

- 12 

### - Administrative volume containing Forms 8570

- 1, 8570

- 4, 8570

- 35, 8570

- 35, applicat ion summary, and draft labeling

- 41 data volumes (three copies of each)

If you require further information, please contact me directly

. Thank you.

Sincerely,

Dennis P. Ward, Ph.D.

S eeds Regulatory, U.S. Lead

cc: M ike Mendelsohn / EPA / OPP / BPPDPage 1 of 57 

### Title

Application for Manufacturing

- Use Registration of 5307 Corn (SYN

- Ø 53 Ø 7

- 1 )

ADMINISTRATIVE MATERIALS

Author

D ennis P. Ward, Ph.D.

Date

March 31, 2011

Submitter

Syngenta Seeds , Inc.

– Field Crops

- NAFTA

P.O. Box 12257

3054 E. Cornwallis Road Research Triangle Park, NC 27709

Submitter Reference No.

5307

- EP A

- 12

Volume 1 of 425307

- EPA

- 12 Page 2 of 57 

### S tatement of Data Confidentiality Claim

A claim of confidentiality is being made for information in this application on the basis of its falling within the scope of FIFRA § 10(d)(1) (C). The i nformation claimed confidential has

been removed to a confidential A ppendix and is cited by cross referenc e number in the body

of this volume.

Syngenta submits this material to the United States Environmental Protection Agency (EPA) specifically under provisions contained in FIFRA as amended, and consents to use and disclosure of this material by EPA accordin g to FIFRA. In submitting this material to EPA according to method and format requirements contained in P esticide R egistration No tice 86

- 5 and 40 CFR §158.33, Syngenta do es not waive any protection of rights involving this material that would have been claimed by the company if this material had not been

submitted to the EPA.

Company: Syngenta Seeds , Inc.

– Field Crops

- NAFTA

Submitter : Dennis P. Ward , Ph.D.

Seeds R egulatory , U.S. Lead

Date: March 31, 20115307

- EPA

- 12 Page 3 of 57 

### T able of C ontents

Page No.

Statement of Data Confidentiality Claim

................................ ................................ ............. 2

Transmittal Document

................................ ................................ ................................ ......... 4

Section I. Administrative Materials

................................ ................................ .................... 9

A. Form 8570

- 1

– Application for Pesticide Registration

................................ ................ 9

B. Form 8570

- 4

– Confidential Statement of Formula

................................ ................... 11

C. Form 8570

- 34

– Certification with Respect to Citation of Data

................................ 12

D. Form 8570

- 35

– Data Matrix

................................ ................................ ..................... 13

Section II. Summary of the Application

................................ ................................ ........... 41

A. Introduction

................................ ................................ ................................ ............... 41

B. Nature of Registration Being Requested

................................ ................................ .... 41

C. Justification for the Registration

................................ ................................ ................ 41

D. S ummary of Data Supporting Registration of 5307 Corn

................................ ......... 43

Section III. Product Identity

................................ ................................ ............................... 46

Section IV. Product Label

................................ ................................ ................................ .. 46

Sectio n V. Satisfaction of Registration Data Requirements

................................ .............. 52

A. Product Analysis/Characterization Data Requirements

................................ ............. 52

B. Residue Data Requirements

................................ ................................ ....................... 52

C. Toxicology Data Requirements

................................ ................................ ................. 53

D. Nontarget Organism Data Requirements

................................ ................................ ... 55

E. Environmental Expression Data Requirements

................................ ......................... 56

F. Undocumented Data Requirements

................................ ................................ ............ 56

Section VI. Certification Relating to Child

- Resitant Packaging

................................ ....... 57
Section VII. Request for Classification

................................ ................................ ............ 57
Section VIII. Statement Concerning Tolerances

................................ ............................... 57

Section IX. Fees

................................ ................................ ................................ ................ 57
Section X. Insect Resistance Management

................................ ................................ ........ 575307

- EPA

- 12 Page 4 of 57 

### Transmittal Document

Submitter

Syngenta Seeds, Inc.

– Field Crops

- NAFTA

P.O. Box 12257

3054 E. Cornwallis Road Research Triangle Park, NC 27709

Regulatory Action in Support of Which This Document is Submitted

Application for Manufacturing

- Use Registration of a Plant

- I ncorporated Protectant

Pursuant to FIF RA §3 ( c ) (5) : Bacillus thuringiensis eCry3.1Ab Protein Encoded by Vector pSYN12274 in 5307 C orn

( OECD Unique Identifier: SYN

- Ø 53 Ø 7

- 1 )

File Symbol 67979

-

__

Transmittal Date

March 31, 2011

Submitter Reference No.

5307

- E P A

- 125307

- EPA

- 12 Page 5 of 57 

### List of Accompanying Volumes

V ol

. C ategory 1 

### V olume /S tudy Title MRID

1 A Ward, D. (2010 ). Application for manufacturing

- use registration of 5307 C orn (SYN

- Ø53Ø 7

- 1)

. Reference

No. 5307

- E P A

- 1 2

Product Analysis / Characterization Data

2 B d e Framond (2011). Molecular characterization of event 5307 maize in support of the EU P application. Amended report N o. 1. SSB

- 164

- 08 A1 (Replaces MRID 47734702)

3 B Nelson, A. (2008). Characterization of phosphomannose

isomerase test substance PMI

- 0105 and certificate of analysis. Report No. SSB

- 025

- 07

4 B Nelson, A. (2009). Comparison of phosphomannose isomerase produced in e vent 5307

- derived maize plants and phosphomannose isomerase produced in recombinant

Escheric hia coli . Report No. SSB

- 003

- 09

5 B New, S. (2010). Event 5307 maize: Copy number functional element Southern blot analysis. Report No.

SSB

- 189

- 10 A1

6 B New, S. (2010). Event 5307 maize: Genetic stability analysis. Report No. SSB

- 184

- 10 A1

7 B New, S. (2010). Event 5307 maize: Genome to insert junction analysis for translated open reading frames with a

minimum size of 30 amino acids: Assessment of amino acid sequence similarity to known or putative toxins. Report No. SSB

- 187

- 10

8 B New, S. (2010). Event 5307 maize: Genome to insert junction analysis for translated open reading frames with a

minimum size of 30 amino acids: Assessment of amino acid sequence to known or putative allergens. Report No.

SSB

- 188

- 10

Residue Data

9 B Banach, R. (2010). Validation of the ELISA method for quantitative detection of eCry3.1Ab protein in maize grain, broiler diets, and rat diets. Report No. SSB

- 001

- 10

A1

10 B Bednarcik, M. (2011 ). Quantification of eCry3.1Ab and phosphomannose isomerase in maize tissu es derived from

transformation e vent 5307. Report No. SSB

- 016

- 09 A2

11 B de Fontes, J. (2010). Determination of extract dilution factors and extraction efficiencies for ELISA analysis of transgenic proteins in matrices derived f rom, or including,
maize events 3272, Bt11, MIR162, MIR604 and GA21. Amended report No. 1. Report No. SSB

- 009

- 09 A15307

- EPA

- 12 Page 6 of 57 

### List of Accompanying Volumes (cont.)

V ol. C ategory 1 

### V olume/ S tudy T itle MRID

12 B de Fontes, J. (2010). Modified method for determining the extraction efficiency of transgenic proteins in matrices derived from, or including, maize events 3272, Bt11, MIR162, MIR604 and GA21. Supplement to final Report

No. SSB

- 009

- 09

- A1. Report No. SSB

- 2 20

- 10

13 B d e Fontes, J. (2010). Transfer of a validated ELISA method for quantitative detection of PMI protein. Amended report No. 1. Report No. SSB

- 021

- 09 A1

14 B d e Fontes, J. (2010). Validation of the ELISA method for quantitative detection of PMI protein in grain, sweet corn kernel, broiler diets, and rat diets. Amended report No. 1. Report No. SSB

- 037

- 09 A1

15 B Murray, J. (2008). Validation of the ELISA met hod for quantitative detection of eCry3.1Ab. Report No. SSB

020

- 08

16 B Murray, J. (2009). Validation of a quantitative ELISA method for indication of eCry3.1Ab protein stability and qualification of the eCry3.1Ab positive control for use in the eCry3. 1Ab quantitative ELISA method. Report No.

SSB

- 004

- 09

17 B Nelson, A. (2010). Effect of temperature on the bioactivity of eCry3.1Ab protein as contained in test

substance ECRY3.1AB

- 0208. Report No. SSB

- 014

- 09 A1

18 B Schwartz, B. (2010). Validation of an ELISA method for quantification of eCry3.1Ab protein in maize kernel. Report No. TK0051524

Toxicology Data

19 B Harper, B. (2011). eCry3.1Ab (Entrez database accession number ADC30135): Assessment of amino acid sequence similarity to known or putative allergens. Report No.

SSB

- 112

- 11

20 B Harper, B. (2011). eCry3.1Ab (Entrez database accession number ADC30135): Assessment of amino acid sequence similarity to known or putative toxins. Report No. SSB

165

- 11

21 B Harper, B. (2011). Phosphomannose isomerase (Entrez database accession number AAA24109): Assessment of

amino ac id sequence similarity to known or putative allergens. Report No. SSB

- 102

- 11

22 B Harper, B. (2011). Phosphomannose isomerase (Entrez database accession number AAA24109): Assessment of amino acid sequence similarity to known or putative toxins. Report No. SSB

- 145

- 115307

- EPA

- 12 Page 7 of 57 

### List of Accompanying Volumes (cont.)

V ol

. C ategory 1 

### V olume /S tudy Title MRID

23 B Seastrum, L. (2010). In vitro digestibility of eCry3.1Ab protein as contained in test substance ECRY3.1AB

- 0208 under simulated mammalian intestinal conditions. Report

No. SSB

- 015

- 09 A1

24 B Song, S. (2010). In vitro digestibility of eCry3.1Ab protein under simulated mammalian gastric conditions. Report No. TK0028111

25 B S ong, S . (2010). E ffect of buffer ionic strength on the in

vitro digestibility of e C ry3.1 A b protein under simulated mammalian gastric conditions

. R eport N o. SSB

- 234

- 10

26 B S ong, S . (2010). A comprehensive overview of the

assessment of the in vitro digestibility of e C ry3.1 A b protein under simulated mammalian gastric conditions

. Report No. SSB

- 260

- 10

Nontarget Organism and Environmental Expression Data

27 B Nelson, A. (2010). The env ironmental fate and effects of

e Cry3.1Ab in event 5307 maize: Estimated environmental concentrations, margins of exposure in non

- target organism studies, and US endangered species assessment. Report No. SSB

- 235

- 10

28 B Br ake, J. (2010). Evaluation of e vent 5307 transgenic maize grain in a broiler chicken feeding study. Report No.

SSB

- 211

- 10

29 B Champon, R. and M. Bednarcik (2010). Quantification of eCry3.1Ab and p hosphomannose i somerase in b roiler

c hicken d iets p repared with 5307 m aize g rain . Report No.

TKRS0000138

30 B Hubbard, P. and J. Beavers (2009). eCry3.1Ab

– An acute oral toxicity study with the northern bobwhite. Report No.

528

- 308

31 B McCormac, A. (2010). eCry3.1Ab protein

– A laboratory bioassay of the effects on the earthworm Eisenia fetida in an artificial soil substrate. Report No. SYN

- 09

- 5

32 B Patnaude, M. (2009). eCry3.1Ab protein

– Channel catfish ( Ictalurus punctatus ) feeding study with fish food

prepar ed from grain derived from event 5307 maize. Report No. 1781.6734

33 B Patnaude, M. (2010). eCry3.1Ab and event 5307

– Laboratory study to determine the effects on the predatory

beetle Coleomegilla maculata . Report No. 1781.6728

- A1 (replaces MRID 47753904)5307

- EPA

- 12 Page 8 of 57 

### List of Accompanying Volumes (cont.)

V ol

. C ategory 1 

### V olume /S tudy Title MRID

34 B Picard, C. (2010). eCry3.1Ab protein

– Gammarid ( Gammarus fasciatus ) feeding study with leaf material from event 5307 maize. Report No. 1781.6745

35 B Rentschler, S. (2010). eCry3.1Ab protein

– Assessment of the effects on brood development of the honeybee ( Apis mellifera L.) in a feeding test. Report No. S10

- 00019

36 B Seastrum, L. (2010). Laboratory soil degradation of eCry3.1Ab. Report No. SSB

- 0 07

- 10

37 B Spincer, D. (2009). eCry3.1Ab protein

– A laboratory bioassay of the effects on the rove beetle, Aleochara

bilineata (Coleoptera: Staphylinidae). Report No. SYN

09

- 4

38 B Vinall, S. (2009). eCry3.1Ab protein

– A laboratory bioassay of the effects on the predatory bug, Orius laevigatus (Hemiptera: Anthocoridae). Report No. SYN

09

- 2

39 B Vinall, S. (2010). eCry3.1Ab protein

– A semi

- field bioassay of the effects of oral exposure on brood development of the honeybee, Apis mellifera (Hymenoptera: Apidae). Report No. SYN

- 09

- 1

40 B Vinall, S. (2010). eCry3.1Ab protein

– A laboratory bioassay of the effects on larvae of the ground

- dwelling
beetle, Poecilus cupreus (Coleoptera: Carabidae). Report

No. SYN

- 09

- 3

Other Data

41 C Walters et al. (2010). Lepidopteran

- active variable

- region sequence imparts coleopteran activity in eCry3.1Ab, and engineered Bacillus thuringiensis hybrid insecticidal protein. Appl. Environ. Microbiol. 7 (10): 3082

- 3088.

42 B Vlachos, D. and D. Ward (2011). Public interest assessment supporting US EPA registration of 5307 C o rn and the breeding stacks Bt11 xMIR604xTC1507x5307 and

Bt11xMIR162xMIR604xTC1507x5307 C orn. Report No.

SSB

- 201

- 10

1

– Categorization code for placement of documents in the Public Docket



### Company Official: March 31, 2011 Dennis P. Ward, Ph.D. Date Seeds Regulatory, U.S. Lead

Company Name: Syngenta Seeds, Inc.

– Field Crops

- NAFTA

Company Contact: Dennis P. Ward / Tel. 919.226.73825307

- EPA

- 12 Page 9 of 57 

### Section I. Administrative Materials

A. Form 8 5 7 0

- 1

– Application for Pesticide Registration

(next page)5307

- EPA

- 12 Page 10 of 57 Please read instructions on reverse before completing form

. Form Approved. OMB No. 2070

- 0060

United States 

### Environmental Protection Agency
Washington, DC 20460



#  Registration

Amendment

Other OPP Identifier Number



### Application for Pesticide

– Section I

1. Company/Product Number 

### 67979

- 2. EPA Product Manager 

### Sheryl Reilly 3. Proposed Classification

4. Company/Product (Name) 

### 5307 Corn PM # 

### 92 None Restricted

5. Name and Address of Applicant (Include ZIP Code) 

### Syngenta S eeds, Inc.

- Field Crops

- NAFTA P.O. Box 12257, 3054 East Cornwallis Road Research Triangle Park, NC 27709

Check if this is a new address 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(B)(i), my product is similar or identical in composition and labeling to:

EPA Reg. No.

____________________________________

Product Name ____________________________________



### Section

– II

Amendment

– Explain below.

Resubmission in response to Agency letter dated

Notification

– Explain below. Final printed labels in response to Agency letter dated

“Me Too” Application.

Other

– Explain below.

Explanation: Use additional page(s) if necessary. (For Section I and Section II.) 

### Application for manufacturing

- use registration of 5307 Corn containing a new plant

- incorporated protectant, eCry3.1Ab protein, that protect s corn root s from feeding damage caused by Diabrotica species

.

PRIA category: B8 00 ($ 231,525 ) ; fee has been paid


### Section

– III

1. Material This Product Will Be Packaged In:

Child

- Resistant Packaging

Yes*

No Unit Packaging

Yes

No Water Soluble Packaging

Yes

No 2. Type of Container

Metal

Plastic

Glass

*** Certification must**

**be submitted** If “Yes”

Unit Packaging wgt. No. per

Container If “Yes”

Package wgt. No. per

Container Paper w/ polyurethane liner

Other ( Specify )

________________

3. Location of Net Contents Information

Label Container 4. Size(s) Retail Container 5. Locatio n of Label Directions

On Label

On Labeling accompanying product

6. Manner in Which Label is Affixed to Product Lithograph

Paper glued

Stenciled Other:



### Section

– IV

1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.)

Name 

### Dennis P. Ward , Ph.D. Title 

### Seeds Regulatory, U.S. Lead Telephone No. (Include Area Code) 

### 919.226.7382

Certification

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law. 6. Date Application

Received

2. Signature 3. Title 

### Seeds Regulatory, U.S. Lead 

### ( Stamped)

4. Typed Name 

### Dennis P. Ward , Ph.D. 5. Date 

### March 31, 2011

EPA Form 8570

- 1 (Rev. 8

- 94) Previous editions are obsolete.5307

- EPA

- 12 Page 11 of 57 

### B. Form 8570

- 4

– Confidential Statement of Formula

Confidential Statement of Formula for 5307 Corn:

{CBI Cross Reference Number 1}5307

- EPA

- 12 Page 12 of 57 

### C. Form 8 5 7 0

- 34

– Certification with Respect to Citation of Data

Form Approved OMB No. 2070

- 0060



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue

, N . W. WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration and 0.25 hours per response for reregistration and special review activities, including time for reading the ins tructions and completing the necessary forms. Send comments regarding burden estimate or any other aspect of this collection of information, including su ggestions for reducing the burden to Director, OPPE Information Management Division (2137), U.S. Environmental Prote ction Agency, 401 M Street, S.W., Washington DC, 20460. Do not send the completed form to this address. 

### Certification with Respect to Citation of Data

Applicant’s/Registrant’s Name, Address, and Telephone Number:
Syngenta Seeds, Inc.,

- Field Crops

– NAFTA

P.O. Box 12257, Research Tr iangle Park, NC 27709 (919) 226

- 7382 EPA Registration Number / File Symbol:

67979

-

Active Ingredient(s) and/or representative test compound(s):
Bacillus thuringiensis eCry3.1Ab protein encoded by vector p SYN12274 Date:

March 31, 2011

General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158:
Terrestrial field crop Product Name:

5307 Corn

NOTE: If your product is a 100% repackaging of another purchased EPA

- registered product labeled for all the same uses on your label, you do not need to submit this form. You must submit the Formulator’s Exemption Statement (EPA Form 8570

- 27).

I am responding to a Data

- Call

- in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only)

I am using the cite

- all method of support, and have included with this form a list of companies sent offers of compensation (the Data Matrix Form should be used for this purpose). I am using the selective method of su pport (or cite

- all option under the selective method), and have included with this form a completed list of data requirements (the Data Matrix form must be used).

SECTION II: GENERAL OFFER TO PAY

[Required if using the cite

- all method or when using the cite

- all option under the selective method to satisfy one or more data requirements]

I hereby offer and agree to pay compensation, to othe r persons, with regard to the approval of this application, to the extent required by FIFRA.

SECTION III: CERTIFICATION

I certify that this application for registration, this form for reregistration, or this Data

- Call

- In response is supported by all data submitted or cited in the application for registration, the form for registration, or the Data

- Call

- In response. In addition, if the cite

- all option or cite

- all option under the selective method is indicated in Section 1, this application is s upported by all data in the Agency’s files that (1) concern the properties or effects of this product or an identical or substantially similar product, one or more of the ingredients in this product; and (2) is a type of data that would be required to be s ubmitted under the data requirements in effect on the date of approval of this application if the application sought the initial regis tration of a product of identical or similar composition and uses.

I certify that for each exclusive use study c ited in support of this registration or reregistration, that I am the original data submitter or that I have

o bt ained the written permission of the original data submitter to cite that study.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibil ity for compensation have expired for the study; (d) the study is in the public literature; (e) I have notified in writing the compan y that submitted the study and have offered (i) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3( c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study.

I certify that in all instances where an offer of compensation is required, copies of all offers t o pay compensation and evidence of their delivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request . Should I fail to produce such evidence to the Agency upon request, I unders tand that the Agency may initiate action to deny, cancel

, or suspend the registration of my product in conformity with FIFRA.

I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I ack nowledge that any knowingly false of misleading statement may be punishable by fine or imprisonment of both under the applicable law.

Signature Date

March 31, 2011 Typed or Printed Name and Title

Dennis P. Ward

Seeds Regulatory, U.S. Lead

EPA Form 8570

- 34 (9

- 97) Electronic and Paper Versions available. Submit only Paper version.5307

- EPA

- 12 Page 13 of 57 

### D. Form 8 5 7 0

- 35

– Data Matrix

Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registr ation activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the nec essary forms. Send comments regarding the burden estimate or any other aspect of this collecti on of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U .S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date: March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 1 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note



### Data Supporting eCry3.1Ab and 5307 Corn

Jones, W. (2009). Application for an experimental use permit for Event 5307 Corn. Reference No. 5307

- EPA

- 3 477347

- 00 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.2100

885.3000 Jones, W. (2009). Characterization and safety of eCry3.1Ab protein and corn plants derived from Event

5307. Reference No. 5307

- EPA

- EUP 477347

- 01 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.1200

885.2100 De Framond , A. (2009). Molecular characterization of Event 5307 maize in support of the EUP application. Report No. SSB

- 164

- 08 477347

- 02 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.1100

885.1300

885.1400

885.2000

885.2200 Nelson, A. (2009). Comparison of eCry3.1Ab protein produced in Event 5307

- derived maize plants and eCry3.1Ab protein produced in recombinant Escherichia

coli . Report No. SSB

- 002

- 09 477347

- 03 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 1 7, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 14 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 2 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.1100 Nelson, A. (2008). Characterization of test substance

ECRY3.1AB

- 0208 and certificate of analysis. Report No.

SSB

- 010

- 08 477347

- 04 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.2100 Mims, G. (2008). Bioactivity of test substance

ECRY3.1AB

- 0208. Report No. SSB

- 014

- 08 477347

- 05 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.2000

885.2500 Bednarcik, M. and C. Kramer (2009). Evaluation of transgenic protein levels in multiple generations of plants derived from transformation Event 5307 maize. Report

No. SSB

- 011

- 08 477347

- 07 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.3000

885.3050 Harper, B. (2009). eCry3.1Ab: Assessment of amino acid sequence homology with known toxins. Report No.

SSB

- 123

- 09 477347

- 09 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.3400 Harper, B. (2009). eCry3.1Ab: Assessment of amino acid sequence homology with known or putative allergens. Report No. SSB

- 103

- 09 477347

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

S eeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 15 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 3 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.3000

885.3050 Seastrum, L. (2009). In vitro digestibility of eCry3.1Ab protein as contained in test substance ECRY3.1AB

- 0208 and in 5307 maize under simulated mammalian gastric conditions. Report No. SSB

- 024

- 08 477347

- 11 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.4000 Raybould, A. (2009). Environmental safety assessment of field trials of 5307 maize and breeding stacks combining 5307 with Bt11, DAS

- 59122

- 7, MIR162, MIR604 and

TC1507 maize. 477347

- 14 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.2300 Murray, J. and W. Jones (2009). Kit for eCry3.1Ab testing in leaf, seed and bulk grain corn. 477347

- 17 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

N/A Haney, L. et al. (2008). Efficacy of 5307 maize hybrids against western corn rootworm in the field. Report No.

SSB

- 505

- 08 477347

- 18 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

N/A Haney, L. et al. (2009). 2008 efficacy of a 5307 maize hybrid against western corn rootworm in the field. Report

No. SSB

- 139

- 09 477347

- 19 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

S eeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 16 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 4 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.3000

885.3050

885.4150 Korgaonkar, C. (2009). ECRY3.1AB

- 0208: Single

- dose oral (gavage) toxicity study in mice with 14

- day observation period. Report No. WIL

- 639031 477539

- 01 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.2300 Murray, J. (2008). Validation of a quantitative eCry3.1Ab ELISA for analysis of maize leaf, root, kernel, and pollen extracts. Report No. SSB

- 021

- 08 477539

- 02 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.4380 Vinall, S. (2008). Laboratory bioassay to determine the oral toxicity of pollen of Event 5307 maize to adults of the honeybee, Apis mellifera . Report No. SYN

- 08

- 42 477539

- 03 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.4340 Patnaude, M. (2009). eCry3.1Ab and Event 5307

- 07MG005417 pollen: laboratory study to determine the effects of eCry3.1Ab and Event 5307

- 07MG005417 pollen on the predatory beetle Coleomegilla maculata

. Report No. 1781.6728 477539

- 04 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

885.3000

885.3050 Graser, G. et al. (2010). Supplemental information for study SSB

- 024

- 08: In vitro digestibility of eCry3.1Ab protein as contained in test substance ECRY3.1AB

- 0208 and in 5307 maize under simulated mammalian gastric conditions (MRID 477347

- 11). Report No. SSB

- 015

- 10 480384

- 01 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated

Marc h 22, 2010 Signature Name and Title

Dennis P. Ward, Ph.D.

S eeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 17 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 5 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Ward, D. (2010). Application for manufacturing

- use registration of 5307 corn (SYN

- Ø53Ø7

- 1). Reference

No. 5307

- EPA

- 12 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 1

885.1200

885.2100 De Framond (2011). Molecular characterization of event 5307 maize in support of the EUP application. Amended report No. 1. SSB

- 164

- 08 A1 (Replaces MRID 47734702) Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 2

885.1200

885.2100 New, S. (2010). Event 5307 maize: Copy number functional element Southern blot analysis. Report No.

SSB

- 189

- 10 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 5

885.1200

885.2100 New, S. (2010). Event 5307 maize: Genetic stability analysis. Report No. SSB

- 184

- 10 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 6

885.1200

885.2100 New, S. (2010). Event 5307 maize: Genome to insert junction analysis for translated open reading frames with

a minimum size of 30 amino acids: Assessment of amino acid sequence similarity to known or putative toxins. Report No. SSB

- 187

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 7 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 18 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 6 of 1 4

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.1200

885.2100 New, S. (2010). Event 5307 maize: Genome to insert junction analysis for translated open reading frames with

a minimum size of 30 amino acids: Assessment of amino acid sequence to known or putative allergens. Report No.

SSB

- 188

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 8

885.2300 Banach, R. (2010). Validation of the ELISA method for quantitative detection of eCry3.1Ab protein in maize grain, broiler diets, and rat diets. Report No. SSB

- 001

- 10

- A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 9

885.2000

885.2500 Bednarcik, M. (2011). Quantification of eCry3.1Ab and phosphomannose isomerase in maize tissues derived from transformation Event 5307. Report No. SSB

- 016

- 09 A2 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 10

885.2300 de Fontes, J. (2010). Determination of extract dilution factors and extraction efficiencies for ELISA analysis of transgenic proteins in matrices derived from, or including, maize events 3272, Bt11, MIR162, MIR604 and GA21. Amended report No. 1. Report No . SSB

- 009

- 09 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 11

885.2300 Murray, J. (2008). Validation of the ELISA method for quantitative detection of eCry3.1Ab. Report No. SSB

020

- 08 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 15 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 19 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 7 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.2300 Murray, J. (2009). Validation of a quantitative ELISA method for indication of eCry3.1Ab protein stability and qualification of the eCry3.1Ab positive control for use in the eCry3.1Ab quantitative ELISA method. Report No.

SSB

- 004

- 09 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 16

885.2100 Nelson, A. (2010). Effect of temperature on the bioactivity of eCry3.1Ab protein as contained in test

substance ECRY3.1AB

- 0208. Report No. SSB

- 014

- 09

A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 17

885.2300 Schwartz, B. (2010). Validation of an ELISA method for quantification of eCry3.1Ab protein in maize kernel. Report No. TK0051524 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 18

885.3400 Harper, B. (2011). eCry3.1Ab (Entrez database accession number ADC30135): Assessment of amino acid sequence similarity to known or putative allergens. Report No. SSB

- 112

- 11 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 19

885.3000

885.3050 Harper, B. (2011). eCry3.1Ab (Entrez database accession number ADC30135): Assessment of amino acid sequence similarity to known or putative toxins. Report

No. SSB

- 165

- 11 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 20 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 20 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 8 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.3000

885.3050 Seastrum, L. (2010). In vitro digestibility of eCry3.1Ab protein as contained in test substance ECRY3.1AB

- 0208 under simulated mammalian intestinal conditions. Report

No. SSB

- 015

- 09 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 23

885.3000

885.3050 Song, S. (2010). In vitro digestibility of eCry3.1Ab protein under simulated mammalian gastric conditions. Report No. TK0028111 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 24

885.3000

885.3050 Song, S. (2010). Effect of buffer ionic strength on the in

vitro digestibility of eCry3.1 A b protein under simulated mammalian gastric conditions. Report No. SSB

- 234

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 25

885.3000

885.3050 Song, S. (2010). A comprehensive overview of the

assessment of the in vitro digestibility of eCry3.1Ab protein under simulated mammalian gastric conditions. Report No. SSB

- 260

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 26

885.4000 Nelson, A. (2010). The env ironmental fate and effects of

e Cry3.1Ab in event 5307 maize: Estimated environmental concentrations, margins of exposure in

non

- target organism studies, and US endangered species

assessment. Report No. SSB

- 235

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 27 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 21 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 9 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.4050 Brake, J. (2010). Evaluation of event 5307 transgenic maize grain in a broiler chicken feeding study. Report

No. SSB

- 211

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 28

885.4050 Champon, R. and M. Bednarcik (2010). Quantification of eCry3.1Ab and phosphomannose isomerase in broiler chicken diets prepared with 5307 maize grain. Report

No. TKRS0000138 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 29

885.4050 Hubbard, P. and J. Beavers (2009). eCry3.1Ab

– An acute oral toxicity study with the northern bobwhite. Report No. 528

- 308 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 30

885.4000 McCormac, A. (2010). eCry3.1Ab protein

– A laboratory bioassay of the effects on the earthworm Eisenia fetida in an artificial soil substrate. Report No. SYN

- 09

- 5 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 31

885.4200 Patnaude, M. (2009). eCry3.1Ab protein

– Channel catfish ( Ictalurus punctatus ) feeding study with fish food prepared from grain derived from event 5307 maize. Report No. 1781.6734 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 32 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 22 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 10 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.4340 Patnaude, M. (2010). eCry3.1Ab and event 5307

– Laboratory study to determine the effects on the predatory

beetle Coleomegilla maculata . Report No. 1781.6728

- A1 (replaces MRID 47753904) Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 33

885.42 40 Picard, C. (2010). eCry3.1Ab protein

– Gammarid ( Gammarus fasciatus ) feeding study with leaf material from event 5307 maize. Report No. 1781.6745 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 34

885.4380 Rentschler, S. (2010). eCry3.1Ab protein

– Assessment of the effects on brood development of the honeybee ( Apis mellifera L.) in a feeding test. Report No. S10

- 00019 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 35

885.5200 Seastrum, L. (2010). Laboratory soil degradation of eCry3.1Ab. Report No. SSB

- 007

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 36

885.4340 Spincer, D. (2009). eCry3.1Ab protein

– A laboratory bioassay of the effects on the rove beetle, Aleochara

bilineata (Coleoptera: Staphylinidae). Report No. SYN

09

- 4 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 37 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 23 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 11 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.4340 Vinall, S. (2009). eCry3.1Ab protein

– A laboratory bioassay of the effects on the predatory bug, Orius laevigatus (Hemiptera: Anthocoridae). Report No. SYN

09

- 2 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 38

885.4380 Vinall, S. (2010). eCry3.1Ab protein

– A semi

- field bioassay of the effects of oral exposure on brood development of the honeybee, Apis mellifera (Hymenoptera: Apidae). Report No. SYN

- 09

- 1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 39

885.4340 Vinall, S. (2010). eCry3.1Ab protein

– A laboratory bioassay of the effects on larvae of the ground

- dwelling beetle, Poecilus cupreus (Coleoptera: Carabidae). Report

No. SYN

- 09

- 3 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 40

Walters et al. (2010). Lepidopteran

- active variable

- region sequence imparts coleopteran activity in eCry3.1Ab, and engineered Bacillus thuringiensis hybrid insecticidal protein. Appl. Environ. Microbiol. 7 (10): 3082

- 3088. Syngenta Seeds, Inc.

- Field Crops PL Submission

Volume 41

Vlachos, D. (2011). Public interest assessment supporting US EPA registration of 5307 corn and the breeding stacks

Bt11 x MIR604 x TC1507 x 5307 and Bt11 x MIR162 x

MIR604 x TC1507 x 5307 corn. Report No. SSB

- 201

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 42 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 24 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 1 2 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note



### Data Supporting PMI Marker Protein

885. 3000

885.3050

885.4150 Kuhn, J. (1999). Phosphomannose isomerase (sample

PMI

- 0198): Acute oral toxicity in mice. Report No.

4708

- 98 459344

- 07 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated May 1, 2003

885.3000

885.3050 Privalle, L. (1999). In vitro digestibility of PMI protein under simulated mammalian gastric and intestinal conditions. Report No. NSB

- 002

- 99 459344

- 08 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated May 1, 2003

885.2100 Hill, K. (2003). Effects of temperature on the stability of phosphomannose isomerase. Report No. SSB

- 013

- 03 459344

- 09 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated May 1, 2003

885.3000

885.3050 Harper, B. (2009). Phosphomannose isomerase (Entrez database accession number AAA24109): Assessment of amino acid sequence homology with known toxins. Report No. SSB

- 125

- 09 477347

- 12 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 1 7 , 20 09 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 25 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 13 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.3400 Harper, B. (2009). Phosphomannose isomerase (Entrez database accession number (AAA24109): Assessment of amino acid sequence homology with known or putative allergens. Report No. SSB

- 101

- 09 477347

- 13 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 1 7 , 20 09

885.2100 Green, P. (2010). Accurate mass measurement (characterization) of the phosphomannose isomerase (PMI) test substances PMI

- 0198 and PMI

- 0105 using liquid chromatography / mass spectrometry (LC/MS). Amended report 2. Report No. J7460

- JH

- JULY07

- A2 482023

- 06 Syngenta Seeds, Inc.

- Field Crops OWN Submission dated August 17 , 20 09

885.2100 Nelson, A. (2008). Characterization of phosphomannose

isomerase test substance PMI

- 0105 and certificate of analysis. Report No. SSB

- 025

- 07 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 3

885.1100

885.1300

885.1400

885.2000

885.2200 Nelson, A. (2009). Comparison of phosphomannose isomerase produced in event 5307

- derived maize plants and phosphomannose isomerase produced in recombinant

Escherichia coli . Report No. SSB

- 003

- 09 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 4

885.2300 de Fontes, J. (2010). Modified method for determining the extraction efficiency of transgenic proteins in matrices derived from, or including, maize events 3272, Bt11, MIR162, MIR604 and GA21. Supplement to final Report

No. SSB

- 009

- 09

- A1. Report No. SSB

- 2 20

- 10 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 12 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 26 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 14 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

885.2300 De Fontes, J. (2010). Transfer of a validated ELISA method for quantitative detection of PMI protein. Amended report No. 1. Report No. SSB

- 021

- 09 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 13

885.2300 De Fontes, J. (2010). Validation of the ELISA method for quantitative detection of PMI protein in grain, sweet corn kernel, broiler diets, and rat diets. Amended report No. 1. Report No. SSB

- 037

- 09 A1 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 14

885.3400 Harper, B. (2011). Phosphomannose isomerase (Entrez database accession number AAA24109): Assessment of amino acid sequence similarity to known or putative allergens. Report No. SSB

- 102

- 11 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 21

885.3000

885.3050 Harper, B. (2011). Phosphomannose isomerase (Entrez database accession number AAA24109): Assessment of amino acid sequence similarity to known or putative toxins. Report No. SSB

- 145

- 11 Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 22

Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy5307

- EPA

- 12 Page 27 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date: March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 1 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngent a Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 28 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 2 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 29 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U .S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 3 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 30 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, includ ing time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Manag ement Division (2137), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 4 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated March 22, 2010 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 31 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 5 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 1

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 2

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 5

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 6

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 7 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 32 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 6 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 8

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 9

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 10

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 11

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 15 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 33 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 7 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 16

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 17

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 18

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 19

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 20 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 34 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 8 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 23

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 24

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 25

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 26

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 27 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 35 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 9 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 28

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 29

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 30

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 31

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 32 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 36 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 10 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 33

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 34

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 35

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 36

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 37 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 37 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 11 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 38

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 39

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 40

Syngent a Seeds, Inc.

- Field Crops PL Submission

Volume 41

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 42 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 38 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 12 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission May 1, 2003

Syngenta Seeds, Inc.

- Field Crops OWN Submission May 1, 2003

Syngent a Seeds, Inc.

- Field Crops OWN Submission May 1, 2003

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 39 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 13 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission dated April 17, 2009

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 3

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 4

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 12 Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 40 of 57 Form Approved OMB No. 2070

- 0060 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registrati on activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruct ions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envir onmental Protection Agency, 1200 Pennsylvania Avenue, N.W. , Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX

Date : March 31, 2011 EPA Reg. No. / File Symbol:
67979

- Page 14 of 14

Applicant's/Registrant's Name & Address: Syngenta Seeds, Inc.

– Field Crops

- NAFTA , P.O. Box 12257, Research Triangle Park, NC 27709 Product:
5307 C orn

Ingredient Bacillus thuringiensis eCry3.1Ab insecticidal protein encoded by vector pSYN12274

Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 13

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 14

Syngenta Seeds, Inc.

- Field Crops OWN Submission

Volume 21

Syngent a Seeds, Inc.

- Field Crops OWN Submission

Volume 22

Signature Name and Title

Dennis P. Ward, Ph.D.

Seeds Regulatory , U.S. Lead Date

March 31, 2011

EPA Form 8570

- 35 (9

- 97) Electronic and Paper versions available. Submit only Paper version. Public File Copy5307

- EPA

- 12 Page 41 of 57 

### Section II. S ummary of the Application

A. Introduction

Using the techniques of modern molecular biology, Syngenta has transformed corn ( ‘maize’, Zea mays L. ) to produce 5307 C orn, a new cultivar that is protected from root feeding damage caused by corn rootworms ( Diabrotica sp

. ). P lan ts derived from transformation

e vent 5307 Corn contain the engineered gene ecry3.1Ab encoding an eCry3.1Ab recombinant fusion protein and the gene pmi (also known as manA ) encoding the enzyme

p hosphomannose isomerase (PMI). eCry3.1Ab protein is a fusion of domains from the modified Cry3A (mCry3A) and Cry1Ab proteins, members of a class of insecticidal proteins

derived from Bacillus thuringiensis (Bt ). The gene pmi originates from Escherichia c oli

strain K

- 12 and the protein it encodes was utilized as a plant selectable marker during development of 5307 Corn

.

B. Nature of Registration Being Requested

A n a pplication for a manufacturing

- use r egistration of a p lant

- i ncorporated p rotectant (PIP)

p ursuant to FIF RA §3(c)(5) is being sought for the eCry3.1Ab protein e ncoded by v ector

p SYN12274 in 5307 Corn

. Syngenta will not be offering 5307 Corn as a stand

- alone trait for sale to growers. Event 5307 Corn will be combined through conventional breedi ng with other transgenic corn events contain ing registered PIPs and offered for sale to growers

. Separate registrations are being sought for these PIP breeding stack end

- use products. The manufacturing

- use registration for 5307 Corn is being sought to all ow planting for breeding

purposes, research, agronomic testing, increasing inbred seed s tocks , and producing hy brid

seed

. Commercial plantings for the purpose of controlling corn insect pests and grain production will be prohibited under this registration. This registration will also allow for the production of inbreds and hybrids that contain combinations of registered PIP s ( i.e. breeding stacks). Corn hybrids containing event 5307 and another rootworm

- active PIP will provide a higher level of root protection under high rootworm pressure compared to hybrids containing a single rootworm

- active PIP. In addition

, the pyramid of PIPs will significantly reduce

insect resistance risk. Data and information are provided herein to support a finding that issuance of these registrations will be in the public interest (see Volume 42)

.

C. Justification for the Registration

Corn is the most widely cultivated U.S. crop, in terms of acreage planted and net value. Transgenic corn hybrids that produce Bacillus thuringiensis

- derived Cry proteins for targeted

rootworm control have been available in the U.S. since 2003. Prior to their introduction,

control of Diabrotica rootworms accounted for the largest single use of conventional

insecticides in the U.S. Transgenic corn hybrids currently available to U.S. growers for rootworm control have significantly improved growers’ ability to co ntrol these pests while reducing use of broad

- spectrum soil

- applied insecticides. The at tendant benefits of the PIP

rootworm

- control traits on the market include higher and more consistent grain yield, economic benefits to growers, healthier plants, impro ved worker safety, and reduced use of5307

- EPA

- 12 Page 42 of 57 

### fossil fuels to apply insecticide treatments. The deployment of 5 307 corn, in the breeding

combinations of Bt11×MIR604×TC1507×5307 C orn and Bt11×M IR162×MIR604×

TC1507×5307 C orn, will offer these same qualitative benef its.

Reduction of broad

- spectrum insecticide use by growers is of special importance because several conventional pesticide products registered for corn rootworm control have use restrictions or label warnings related to their potential to be highly tox ic to humans and/or

wildlife. R egistration of the PIP in 5307 C orn and the breeding combinations thereof is expected to further reduce chemical insecticide use by corn growers. Based on an extensive battery of safety studies provided for review by the U. S. Environmental Protection Agency, the eCry3.1Ab protein poses no significant human health or environmental risks, either in

5307 C orn alone or in the PIP breeding combinations described above.

Field studies demonstrate that the eCry3.1Ab protein in 5307 C orn is highly effective in controlling the larvae of three important U.S. rootworm pests: Diabrotica virgifera virgifera LeConte (western corn rootworm), D. longicornis barberi Smith and Lawrence (northern corn rootworm), and D. virgifera zeae Krysan an d Smith (Mexican corn rootworm). In the presence of high r ootworm infestations, 5307 C orn hybrids have also demonstrated a significant yield advantage in side

- by

- side comparisons with nontransgenic, near

- isogenic control hybrids (see Volume 42)

.

5307 C or n, offered in Bt11×MIR604× TC 1507× 5307 C orn and Bt11×MIR162×MIR604×

TC1507×5307 Co rn
, will provide important new choices in pest control, thus promoting marketplace competition and higher adoption rates of biotechnology

- derived corn varieties.
Moreover, studies demonstrate that the eCry3.1Ab protein in 5307 C orn has a unique mode

of insecticide action 1 

### and targets a different gut binding site in corn rootworm larvae than

does the mCry3A protein in Syngenta’s registered MIR604 C orn, a component of both

bre eding stacks above. The concurrent deployment of both e Cry3.1Ab and mCry3A in hybrid offerings is expected to preserve target pest susceptibility to both Cry proteins. Additionally, by reducing the selection pressure on rootworm populations to evolve

res istance to any single method of control, this strategy is predicted to help prolong pest susceptibility to other B. thuringiensis

- derived rootworm

- control proteins in transgenic corn cultivars, as well as to other established control methods, including con ventional insecticides

a nd crop rotation practices.

Current insect resistance management strategies for Bt corn products are centered around the planting of a structured refuge that can provide a source of susceptible adult insects with

which rare resista nt insects can mate, thereby preventing or delaying the establishment of resistance genes in a population. The size and configuration of the structured refuge are determined by toxin dose and insect biology. A second important aspect of combining eCry3.1 Ab and mCry3A in a single product is that the minimum size of the on

- farm refuge required to delay resistance can be reduced from 20% of a grower’s total corn acreage (e.g., for MIR604 corn or other corn products with single rootworm

- control traits) to 5% of a

1 Walters et al. (2010). Lepidopteran

- active variable

- region sequence imparts coleopteran activity in eCry3.1Ab, and engineered Bacillus thuringiensis hybrid insecticidal protein. Appl. Environ. Microbiol. 7 (10): 3082

- 3088.5307

- EPA

- 12 Page 43 of 57 

### grower’s acreage. This will offer additional pest control benefits on what would previously have been refuge acres, will reduce the environmental impact of insecticide use on refuge acres, and will increase grower compliance with refuge requirements. Corn hybrids producing both eCry3.1Ab and mCry3A will represent an important and effective new tool in the corn grower’s arsenal of r ootworm control option s.

D

. Summary of Data Supporting Registration of 5307 Corn

Product identity, characterization, human safety, environment safety , residue, and exposure

studies have been conducted on 5307 C orn and the eCry3.1Ab protein. Reports for many of

these studies were submitted to EPA in April 2009 as part of an experimental use permit application (permit no. 67979

- EUP

- 8) and are list ed in the Data Matrix . Reports for the remaining studies are included in this application.

5307 Corn was produced by Agrobacterium tumefaciens

- mediated transformation of immature maize embryos using the plasmid pSYN12274. The region between the left and right borders of the transformation plasmid included gene expression cassettes for ecry3.1Ab

and pmi ; this T

- DN A was transferred into the corn genome during transformation. The ecry3.1Ab expression cassette consisted of the ecry3.1Ab coding region regulated by a cestrum yellow leaf curling virus promoter (CMP) and a nopaline synthase (NOS) polyadenylation sequence. The pmi expression cassette c onsisted of the pmi coding region regulated by a Zea mays polyubiquitin (ZmUbiInt) promoter and the NOS polyadenylation

sequence.

Southern blot analyses demonstrate that 5307 Corn (1) contains, at a single locus within the

corn ( Z. mays ) genome, a single copy each of the gene ecry3.1Ab , its CMP promoter sequence, the marker gene pmi (also known as manA ) , its ZmUbiInt promoter sequence, and the two expected copies of the NOS polyadenylation sequence, one NOS polyadenylation sequence regulating ecry3.1Ab and one NOS polyadenylation sequence regulating pmi ; (2) does not contain any extraneous deoxyribonucleic acid (DNA) fragments of the functional

elements inserted elsewhere in the corn genome; (3) and does not contain backbone sequence

from the transformation plasmid, pSYN12274.

Nucleotide seque nce analysis of the entire 5307 Corn T

- DNA confirms that the insert is intact and that the organization of the functional elements within the insert is identical to their organization within pSYN12274. One nucleotide change compared to the sequence of pSYN12274 was identified 48 base pairs (bp) upstream of the CMP promoter in a non

codin g region of the insert in 5307 Corn . However, this nucleotide change had no effect on the functionality of the insert. Additionally, the analysis indicates that some truncation of the nucleotide sequence occurred at the 5' and 3' ends of the T

- DNA during the transformation process that resulted in 5307 Corn ; such truncation occurs commonly in transformation via Agrobacterium . The enti re right border and three bp of non

- coding sequence at the 5' end of the insert, and eight bp of the left border were truncated; however, these deletions had no effect on the functionality of the insert.

Sequence analysis of the T

- DNA insertion site demon strates that 33 bp of corn genomic5307

- EPA

- 12 Page 44 of 57 

### sequence were deleted when the 5307 Corn T

- DNA integrated into the genome. Basic Local Alignment Search Tool (BLAST) analyses comparing the corn genomic sequence flanking

the T

- DNA to sequences in public databases indica te that the insert does not disrupt any known endogenous corn gene.

Translations of any putative open reading frame (ORF) spanning either the junction between

corn genomic sequence and the 3' region of the 5307 Corn T

- DNA or the junction between

corn geno mic sequence and the 5' region of the 5307 Corn T

- DNA were screened for amino acid sequence similarity to known or putative allergens or toxins. Comparisons to the FARRP Allergen Online database suggest that the amino acid translation of the identified putative ORF shows no biologically relevant amino acid sequence similarity to any known or putative protein allergens. Additionally, the results of a comprehensive amino acid simila rity search of the NCBI Entrez® Protein Database suggest that the amino acid translation of the identified putative ORF shows no biologically relevant amino acid sequence similarity to any known or putative toxins. These data demonstrate that there are no deleterious changes in the

5307 C orn genome as a result of the T

- DNA insertion.

The ecry3.1Ab and pmi segregation ratios over several generations of 5307 Corn plants are consistent with linkage of these transgene s at a single locus in the corn nuclear ge nome. These data and the results from Southern blot analyses of several generations of 5307 Corn indicate that the transgenic locus is stably inherited during conventional breeding

T he ecry3.1Ab and pmi genes are derived from source organisms with a hist ory of safe use and the proteins that are produced have modes

- of

- action that are well understood. Extensive bioinformatics searches were performed to confirm that eCry3.1Ab and PMI amino acid sequences did not share significant similarity with protein seq uences identified as toxins.

PMI ha s no significant sequence similarity and eCry3.1Ab only exhibited significant sequence similarity w ith other Cry δ

- endotoxins , as would be expected. The potential mammalian toxicity of both of these proteins was evaluat ed by performing acute oral toxicity studies in mice. No toxicity was observed at very high doses (2000 mg protein/kg body weight or higher). Therefore, both eCry3.1Ab and PMI are considered essentially nontoxic.

A rigorous assessment of the potential allergenicity of eCry3.1Ab and PMI proteins was conducted using a weight

- of

- evidence approach. Neither eCry3.1Ab nor PMI is derived from a source organism known to produce allergenic proteins. No significant amino acid

sequence similarities of eCry3.1Ab or PMI to known or putative allergenic protein sequences were identified. Both eCry3.1Ab and PMI were rapidly degraded in simulated mammalian gastric fluid and were inactivated and thus denatured when exposed to heat. Based on this evidence, both eCry3. 1Ab and PMI were considered unlikely to be food allergens. Furthermore, the potential for mammalian exposure to these proteins is minimal based on their very low expression levels in corn tissues.

Ecologically significant concentrations of eCry3.1Ab ar e unlikely to occur outside fields

where 5307 C orn is cultivated. The eCry3.1Ab protein is unlikely to spread as a result of pollen

- or seed

- mediated gene flow, soil accumulation

, or by horizontal gene transfer.

Pollen

- or seed

- mediated gene flow is unli kely because there are no free

- living wild relatives5307

- EPA

- 12 Page 45 of 57 

### of corn in the United States and the probability that self

- sustaining feral populations of 5307

C orn will form is low. Horizontal gene transfer and subsequent expression of eCry3.1Ab in

soil microbes ar e unlikely due to several factors, including the use of plant

- optimized codons in the gene ecry3.1Ab . A soil degradation study showed that a short incubation period in live soil results in the loss of biological activity of eCry3.1Ab. Thus, the persisten ce of bioactive eCry3.1Ab in soil following cultivation of 5307 C orn will likely be brief. The transfer of plant material into waterways surrounding fields may occur, however it is unlikely to result in ecologically significant concentrations of eCry3.1Ab . Degradation of protein is likely to occur between harvest and the transfer of plant material into water bodies. Additionally, analysis of 5307 C orn tissues by enzyme

- linked immunosorbent assay showed that the mean concentration of eCry3.1Ab was lowest at senescence, the developmental stage from which

most post

- harvest plant debris will originate. Therefore, the spread of eCry3.1Ab via soil,

from dis persal of plant debris or from gene flow is unlikely to result in ecologically significant concentrations of eCry3.1Ab outside corn cultivation.

The concentrations of eCry3.1Ab measured in relevant 5307 C orn tissues were used to

determine estimated envi ronmental concentrations (EECs) of eCry3.1Ab for groups of organisms potentially exposed via cultivation of 5307 C orn . Two sets of EECs for nontarget organisms ( NTOs ) were calculated: worst

- case and conservative EECs. The worst

- case EECs were taken as t he highest mean concentration of eCry3.1Ab measured in the relevant tissue type. Worst

- case EECs were refined via conservative assumptions of the dilution of eCry3.1Ab in prey, in soil, or by other means to calculate conservative EECs.

Eleven species r epresenting NTOs potentially exposed to eCry3.1Ab via cultivation of 5307

C orn were exposed to microbially produced eCry3.1Ab or 5307 C orn tissue in the laboratory. These test species included three species within the order Coleoptera, the order which als o includes the pests sensitive to eCry3.1Ab. The NTOs were exposed to concentrations of eCry3.1Ab that were 1X to 1800X the conservative EEC and monitored for adverse effects on survival and in some cases development. No effects on survival were observed in any study. In a single study, a 20% reduction in weight of adult carabid beetles ( Poecilus cupreus) emerging from larvae fed eCry3.1Ab was observed versus controls. The Poecilus

cupreus were exposed to an eCry3.1Ab concentration that was 62X the wors t

- case EEC with no adverse effects on survival, and only minor effects on adult beetle weight. Therefore, effects of eCry3.1Ab on ground beetles are likely to be negligible during field exposure to

5307 C orn

.

The comparison of the hazard and exposure data corroborates the hypothesis that eCry3.1Ab is not harmful to NTOs at concentrations likely to result from the cultivation of 5307 C orn
, and provides a weight of evidence that eCry3.1Ab in 5307 C orn will have n o harmful effects on populations of potentially exposed NTOs. Additionally, the cultivation of 5307 C orn is predicted to pose negligible risk to federally listed endangered or threatened Coleoptera.5307

- EPA

- 12 Page 46 of 57 

### Section III. Product Identity

Product name: 530 7 Corn

Trade name(s): none at this time

EPA registration number: 67979

-

__

OECD Unique Identifier: SYN

- 

### Ø53Ø7

- 1

Section IV. Pro duct Label

Five copies of the draft label for 5307 Corn are presented on the following pages.5307

- EPA

- 12 Page 47 of 57 

## 5307 Corn

Insect Control Protein Manufacturing

- Use Product (OECD Unique Identifier SYN

- 

### Ø53Ø7

- 1)

Active Ingredient: Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

............. 0.00 034

– 0.0 1782 %*



### Other Ingredient:

M arker protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

................................ ................. 0.000 0 4

– 0.000 88 %*

*Percent dry weight , whole plant



### CAUTION Keep Out of Reach of Children

EPA Registration Number 67979

- Syngenta Seeds, Inc.

– Field Crops

- NAFTA

EPA Establishment N umber 66736

- NC

- 1 P.O. Box 12257

3054 E. Cornwallis Rd.
NET CONTENTS: _______ Research Triangle Park, NC 27709

DIRECTIONS FOR USE

Use of this plant

- incorporated protectant in a manner inconsistent with the terms of this label

is a violation of Federal law. 5307 seed corn may only be planted for research and breeding purposes, increasing inbred seed, or producing hybrid seed on up to 250,000 acres per year

. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited.

5307 Corn may be combined through conventional breeding with other registered plant

incor porated protectants that are similarly approved for use in combination, through conventional breeding, with other registered plant

- incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits

.

There are no refuge require men ts for planting of 5307 C orn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal.5307

- EPA

- 12 Page 48 of 57 

## 5307 Corn

Insect Control Protein Manufacturing

- Use Product (OECD Unique Identifier SYN

- 

### Ø53Ø7

- 1)

Active Ingredient: Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

............. 0.00 034

– 0.0 1782 %*



### Other Ingredient:

M arker protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

................................ ................. 0.000 0 4

– 0.000 88 %*

*Percent dry weight , whole plant



### CAUTION Keep Out of Reach of Children

EPA Registration Number 67979

- Syngenta Seed s, Inc.

– Field Crops

- NAFTA

EPA Establishment N umber 66736

- NC

- 1 P.O. Box 12257

3054 E. Cornwallis Rd.
NET CONTENTS: _______ Research Triangle Park, NC 27709

DIRECTIONS FOR USE

Use of this plant

- incorporated protectant in a manner inconsistent with the terms of this label

is a violation of Federal law. 5307 seed corn may only be planted for research and breeding purposes, increasing inbred seed, or producing hybrid seed on up to 250,000 acres per year

. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited.

5307 Corn may be combined through conventional breeding with other registered plant

incor porated protectants t hat are similarly approved for use in combination, through conventional breeding, with other registered plant

- incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits

.

There are no refuge requirem ents for planting of 5307 C orn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal.5307

- EPA

- 12 Page 49 of 57 

## 5307 Corn

Insect Control Protein Manufacturing

- Use Product (OECD Unique Identifier SYN

- 

### Ø53Ø7

- 1)

Active Ingredient: Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

............. 0.00 034

– 0.0 1782 %*



### Other Ingredient:

M arker protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

................................ ................. 0.000 0 4

– 0.000 88 %*

*Percent dry weight , whole plant



### CAUTION Keep Out of Reach of Children

EPA Registration Number 67979

- Syngenta Seeds, Inc.

– Field Crops

- NAFTA

EPA Establishment N umber 66736

- NC

- 1 P .O. Box 12257

3054 E. Cornwallis Rd.
NET CONTENTS: _______ Research Triangle Park, NC 27709

DIRECTIONS FOR USE

Use of this plant

- incorporated protectant in a manner inconsistent with the terms of this label

is a violation of Federal law. 5307 seed corn may only be planted for research and breeding purposes, increasing inbred seed, or producing hybrid seed on up to 250,000 acres per year

. Commercial plantings of this product for the purposes of grain production and controlling insect pests are proh ibited.

5307 Corn may be combined through conventional breeding with other registered plant

incor porated protectants that are similarly approved for use in combination, through conventional breeding, with other registered plant

- incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits

.

There are no refuge requirem ents for planting of 5307 C orn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal.5307

- EPA

- 12 Page 50 of 57 

## 5307 Corn

Insect Control Protein Manufacturing

- Use Product (OECD Unique Identifier SYN

- 

### Ø53Ø7

- 1)

Active Ingredient: Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

............. 0.00 034

– 0.0 1782 %*



### Other Ingredient:

M arker protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

................................ ................. 0.000 0 4

– 0.000 88 %*

*Percent dry weight , whole plant



### CAUTION Keep Out of Reach of Children

EPA Registration Number 67979

- Syngenta Seeds, Inc.

– Field Crops

- NAFTA

EPA Establishment N umber 66736

- NC

- 1 P.O. Box 12257

3054 E. Cornwallis Rd.
NET CONTENTS: _______ Research Triangle Park, NC 27709

DIRECTIONS FOR USE

Use of this plant

- incorporated protectant in a manner inconsistent with the terms of this label

is a violation of Federal law. 5307 seed corn may only be planted for research and breeding purposes, increasing inbred seed, or producing hybrid seed on up to 250,000 acres per year

. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited.

5307 Corn may be combined through conventional breeding with other registered plant

incor porated protectants t hat are similarly approved for use in combination, through conventional breeding, with other registered plant

- incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits

.

There are no refuge requirem ents for planting of 5307 C orn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal.5307

- EPA

- 12 Page 51 of 57 

## 5307 Corn

Insect Control Protein Manufacturing

- Use Product (OECD Unique Identifier SYN

- 

### Ø53Ø7

- 1)

Active Ingredient: Bacillus thuringiensis eCry3.1Ab protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

............. 0.00 034

– 0.0 1782 %*



### Other Ingredient:

M arker protein and the genetic material necessary for its production (via elements of vector pSYN12274) in 5307 Corn (SYN

- 

### Ø53Ø7

- 1 )

................................ ................. 0.000 0 4

– 0.000 88 %*

*Percent dry weight , whole plant



### CAUTION Keep Out of Reach of Children

EPA Registration Number 67979

- Syngenta Seed s, Inc.

– Field Crops

- NAFTA

EPA Establishment N umber 66736

- NC

- 1 P.O. Box 12257

3054 E. Cornwallis Rd.
NET CONTENTS: _______ Research Triangle Park, NC 27709

DIRECTIONS FOR USE

Use of this plant

- incorporated protectant in a manner inconsistent with the terms of this label

is a violation of Federal law. 5307 seed corn may only be planted for research and breeding purposes, increasing inbred seed, or producing hybrid seed on up to 250,000 acres per year

. Commercial plantings of this product for the purposes of grain production and controlling insect pests are prohibited.

5307 Corn may be combined through conventional breeding with other registered plant

incor porated protectants t hat are similarly approved for use in combination, through conventional breeding, with other registered plant

- incorporated protectants to produce inbred corn lines and hybrid corn varieties with combined pesticidal traits

.

There are no refuge requirem ents for planting of 5307 C orn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal.5307

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### Section V

. Satisfaction of Registration Data Requirements

Specific data requirements for obtaining registration of a PIP have not been promulga ted under 40 CFR §174 Subpart H. In the absence of PIP

- specifi c data requirements EPA has

utiliz ed those requirements delineated for microbial pesticides (40 CFR §158.740) as a partial guide for determining if an A pplicant has provided all required data

. In addition to the microbial data requirements there is a core set of studies more pertinent to PIPs that EPA has been requiring of applicants in recent years

. These latter data require ments are not published and beco me know n to the Applicant through pr esubmission consultations with the Agency.

The tables in this section provide a listing of the data requirements applicable to registration

of a PIP as known to Syngenta . A n explanation of how each data requirement i s satisfied in this application is included in the table

. Specific study reports addressing a data requirement are cited either by the volume number within this submission or by MRID if previously

submitted. Not all of the microbial pesticide data requirements are applicable to a PIP given the inherent differences between the two types of products. Where appropriate, a brief explanation i s provided in the table for those data require ments that are not applicable

. The data requirements are organized by OCSPP Microbial Pesticide Test G uideline number, using the 885

- guideline series. OCSPP guideline numbers are not assigned (N/A) to some PIP data requirements.

A. Product Analysis /Characterization D ata Requirements

OPPTS # Data Requirement Method of Satisfaction

885.1100 Product identity Volume s 1 (CSF) and 4

MRIDs 477347

- 03 and 477347

- 04

885.1200 Manufacturing process Volumes 2, 5, 6, 7 and 8

MRID 477347

- 02

885.1300 Formation of unintentional ingredients Volume 4

MRID 477347

- 03

885.1400 Analysis of samples Volume 4

MRID 477347

- 03

885.1500 Certification of limits Volume 1 (CSF)



### B. Residue Data Requirements

OPPTS # Data Requirement Method of Satisfaction

885.2000 Background for residue analysis Volume s 4 and 10

MRID s 477347

- 0 3 and 477347

- 07

885.2100 Chemical identity Volumes 2, 3, 5, 6, 7, 8, and 17

MRIDs 477347

- 01, 477247

- 02, 477347

- 05 , 459344

- 09 and 482023

- 06

885.2200 Nature of residue in plants Volume 4

MRIDs 477347

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### OPPTS # Data Requirement Method of Satisfaction

885.2250 Nature of residue in animals No adverse effects associated wit h mammalian

exposure to the eCry3.1Ab protein in 5307 Corn have been observed, thus they are not of toxicological concern and do not trigger this data requirement.

885.2300 Analytical methods

- plants Volumes 9, 11, 12, 13, 14, 15, 16 and 18

MRIDs 477347

- 17 and 477539

- 02

885.2350 Analytical methods

- animals The eCry3.1Ab protein in 5307 Corn are exempt from the requirement of tolerances, thus an analytical enforcement method is not needed.

885.2400 Storage stability As the eCry3.1Ab and PMI proteins are plant

incorporated there is no need for a determination of

shelf life.

885.2500 Magnitude of residues in plants Volume 10

MRID 477347

- 07

885.2550 Magnitude of residues in meat, milk, poultry, and eggs The eCry3.1Ab protein in 5307 Corn are exempt from the requirement of tolerances, thus animal residue studies are not required.

885.2600 Magnitude of residues in potable water, fish, and irrigated crops The eCry3.1Ab pro tein is a plant

- incorporated

protectant and will not be used in aquatic sites.

5307 Corn seed may be planted near aquatic sites and there is the potential for pollen drift into bodies
of water. However, there are no residues of toxicological concern in 5307 Corn ; thus, aquatic

residue studies are not required.



### C. Toxicology Data Requirements

OPPTS # Data Requirement Method of Satisfaction

885.3000 Background for mammalian toxicity/pathogenicity/ infectivity Volume s 20, 22, 23, 24, 25 and 26

MRIDs 459344

- 07, 459344

- 08, 477347

- 01, 477347

- 09, 477347

- 11, 477347

- 12, 477539

- 01, 480384

- 01,

885.3050 Acute oral toxicity/pathogenicity Volumes 20, 22, 23, 24, 25 and 26,

MRIDs 459344

- 07, 459344

- 08, 477347

- 09, 477347

- 11, 477347

- 12, 477539

- 01, and 480384

- 01 As the eCry3.1Ab protein is not a living organism a pathogenicity determination is not applicable.5307

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### OPPTS # Data Requirement Method of Satisfaction

885.3100 Acute dermal toxicity/pathogenicity The eCry3.1Ab protein is plant

- incorporated, contained within individual plant cells. There is minimal opportunity for human dermal contact because corn is not a hand harvested crop. Furthermore, eCry3.1Ab is of no toxicological
concern; thus, dermal tox icity data are not required. As the protein is not a living organism, a pathogenicity determination is not applicable.

885.3150 Acute pulmonary toxicity/pathogenicity eCry3.1Ab is a plant

- incorporated protein and is not volatile. There is minimal opportunity for human inhalation exposure. The protein is of no toxicological concern; thus, inhalation toxicity data are not required. As the protein is not a living organism, a pat hogenicity determination is not applicable.

885.3200 Acute injection toxicity/pathogenicity eCry3.1Ab is plant

- incorporated and of no toxicological concern. There is minimal opportunity for direct entry of the protein into the blood stream via injury dur ing handling because corn is not a hand harvested crop. As the protein is not a living organism, a pathogenicity determination is not applicable.

885.3400 Hypersensitivity incidents Volumes 19 and 21

MRIDs 477347

- 10 and477347

- 13 Syngenta is aware of no incidents of hypersensitivity

reactions to eCry3.1Ab protein in 5307 Corn

.

885.3500 Cell culture As the eCry3.1Ab protein is not a living organism a

ce ll culture study is not applicable

.

885.3550 Acute toxicology, Tier II No adverse effects were observed at the maximum

attainable oral doses for eCry3.1Ab protein; LD 50 

### determinations are therefore, not possible. Criteria needed to trigger this Tier II study were not met in

the Tier I studies. As the protein is not a living organism, it has no pathogenicity potential.

885.3600 Subchronic toxicity/pathogenicity No evidence of toxicity was observed in Tier I

studies with eCry3.1Ab protein in 5307 Corn

. Criteria needed to trigger this Tier II study were not

met in Tier I stud ies. As the protein is not a living organism, it has no pathogenicity potential.

885.3650 Reproductive/fertility effects No evidence of toxicity was observed in Tier I studies with eCry3.1Ab protein in 5307 Corn

. Criteria needed to trigger this Tier II study were not

met in Tier I studies.5307

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### D. Nontarget Organism Data Requirements

OPPTS # Data Requirement Method of Satisfaction

885.4000 Background for nontarget organism testing Volumes 27 and 31

MRID 477347

- 14

885. 4050 Avian oral, Tier I Volume s 28, 29 and 30

885. 4100 Avian inhalation, Tier I eCry3.1Ab is plant

- incorporated and is not ‘applied’

in aerosol or dust formulations as microbial pesticide products would be. The only airborne

route o f exposure for eCry3.1Ab wou ld be via pollen drift and corn pollen is not of a size that is respirable.

885. 4150 Wild mammal testing, Tier I MRIDs 459344

- 07 and 477539

- 01

885. 4200 Freshwater fish testing, Tier I Volume 32

885.4240 Freshwater aquatic invertebrate testing, Tier I Volume 34

885.4280 Estuarine and marine animal testing, Tier I There will be no ‘direct application’ of eCry3.1Ab

to estuarine, or marine waters. Furthermore, eCry3.1Ab protein does not display a broad spectrum of activity. This data requirement does not apply.

885.4300 No ntarget plant studies, Tier I As eCry3.1Ab protein is not a living organism it is not pathogenic to plants.

885.4340 Nontarget insect testing, Tier

I Volumes 33, 37, 38 and 40

MRID 477539

- 04

885.4380 Honey bee testing, Tier I Volumes 35and 39

MRID 477539

- 03

885.4600 Avian chronic pathogenicity and reproduction test, Tier III No adverse effects were observed in Tier I studies

and eCry3.1Ab is not persistent in the environment. Criteria needed to trigger higher tier testing are not

met.

885.4650 Aquatic invertebrate range testing, Tier III No adverse effects were observe d in Tier I studies and eCry3.1Ab is not persistent in the environment. Criteria needed to trigger higher tier testing are not

met.

885.4700 Fish life cycle studies, Tier III No adverse effects were observe d in Tier I studies and eCry3.1Ab is not persistent in the environment. Criteria needed to trigger higher tier testing are not

met.

885.4750 Aquatic ecosystem test No adverse effects were observed in Tier I stu dies

and eCry3.1Ab is not persistent in the environment. Criteria needed to trigger higher tier testing are not

met.5307

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### E. Environmental Expression Data Requirements

OPPTS # Data Requirement Method of Satisfaction

885.5200 Expression in a terrestrial

environment Volume 36

885.5300 Expression in a freshwater

environment eCry3.1Ab and 5307 Corn do not have the ability to invade, survive, or replicate in a freshwater environment. Criteria needed to trigger higher tier testing are not met.

885.5400 Expression in a marine or

estuarine environment eCry3.1Ab and 5307 Corn do not have the ability to invade, survive, or replicate in a marine or estuarine environment. Criteria needed to trigger higher tier testing are not met.



### F. Undocumented Data Requi rements

OPPTS # Data Requirement Method of Satisfaction

N/A Product efficacy Not applicable because a manufacturing registration is being sought.

N/A Public interest assessment Volume 425307

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### Section VI. Certification Relating to Child

- Resitant Packaging

Not applicable as eCry3.1Ab is a plant

- incorporated pesticide.

Section VII. Request for Classification

General Use

Section VIII. Statement Concerning Tolerances

A temporary exemption from the requirement of a tolerance has been established for residues of eCry3.1Ab protein in corn (40 CFR §174.532). A petition to convert this temporary tolerance exemption to a nonexpiring tolerance exemption is being submitted to EPA concurrently with this application for registration of 5307 corn.

Phosph omannose isomerase, the marker protein in 5307 Corn, is exempt from the requirement of a tolerance in all plants (40 CFR §174.527).

Section IX. Fees

Proposed PRIA category: B800 [CR No. New active ingredient; establish permanent tolerance base d on tem porary tolerance or tolerance exemption; no SAP review required]

Payment status: A check in the amount of $231,525.00 was transmitted to EPA on March 14, 2011. Certification of payment accompanies the cover letter to the application.

Section X

. Insect Resistance Management

IRM requirements typically associated with planting of Bt corn cultivars are not applied to breeding, field research, inbred seed propagation, and hybrid seed production plantings. IRM requirements are only applied to plantings made by farmers for grain and forage production

. Planting of nonBt in

- field strips or nearby refugia are contraindicated for seed production and breeding activities. The risk of resistance developing and spreading from these breeding and seed production acti vities is low because the acreage involved is limited

.

An IRM plan is not necessary for a manufacturing

- use registration and in would be incompati ble with some breeding and seed production uses . Adherence to an IRM plan is not currently required for th e production of seed corn containing other registered PIPs. It is often not feasible to apply the IRM requirements for registered Bt corn varieties to standard seed production practices. For example, an in

- field or adjacent refuge for an inbred seed prod uction field would contaminate the seed being produced. An exemption from IRM requirements is justified on the basis of the relatively small acreage that will be involved.