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: Application for registration of 5307 Corn, a manufacturing-use product containing an the 

eCry3.1Ab protein plant-incorporated protectant

Dear Dr. Reilly:

Please 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 residues in corn (40 CFR §174.532).

The proposed PRIA category for this action is B800 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 convert the temporary tolerance exemption for eCry3.1Ab in corn to nonexpiring status. 

Please note that Syngenta is simultaneously applying for registrations of two end-use products 

containing the 5307 Corn transformation 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 timeline purposes.

Included in this submission are the following materials:

- Certification of payment
Dr. S. Reilly

March 31, 2011

Page -2-

5307-EPA-12

- Administrative volume containing Forms 8570-1, 8570-4, 8570-35, 8570-35, application 

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.

Seeds Regulatory, U.S. Lead

cc: Mike Mendelsohn / EPA / OPP / BPPD
Page 1 of 57

Title 

Application for Manufacturing-Use Registration of 5307 Corn

(SYN-Ø53Ø7-1)

ADMINISTRATIVE MATERIALS

Author 

Dennis 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-EPA-12

Volume 1 of 42
5307-EPA-12 Page 2 of 57

Statement 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 information claimed confidential has 

been removed to a confidential Appendix and is cited by cross reference 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 according to FIFRA. In submitting this material to EPA 

according to method and format requirements contained in Pesticide Registration Notice 86-5 

and 40 CFR §158.33, Syngenta does 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 Regulatory, U.S. Lead

Date: March 31, 2011

 

 

 

 
5307-EPA-12 Page 3 of 57

 

Table of Contents 

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. Summary of Data Supporting Registration of 5307 Corn .........................................43

Section III. Product Identity...............................................................................................46

Section IV. Product Label..................................................................................................46

Section 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 ........................................................................57
5307-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-Incorporated Protectant

Pursuant to FIFRA §3(c)(5): Bacillus thuringiensis eCry3.1Ab Protein

Encoded by Vector pSYN12274 in 5307 Corn

(OECD Unique Identifier: SYN-Ø53Ø7-1)

File Symbol 67979-__

Transmittal Date 

March 31, 2011

Submitter Reference No. 

5307-EPA-12
5307-EPA-12 Page 5 of 57

List of Accompanying Volumes

Vol. Category1 Volume/Study Title MRID

1 A

Ward, D. (2010). Application for manufacturing-use

registration of 5307 Corn (SYN-Ø53Ø7-1). Reference 

No. 5307-EPA-12

Product Analysis/ Characterization Data

2 B

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)

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 event 5307-derived maize plants 

and phosphomannose isomerase produced in recombinant 

Escherichia 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 tissues derived from 

transformation event 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 from, or including, 

maize events 3272, Bt11, MIR162, MIR604 and GA21. 

Amended report No. 1. Report No. SSB-009-09 A1
5307-EPA-12 Page 6 of 57

List of Accompanying Volumes (cont.)

Vol. Category1 Volume/Study Title 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-220-10

13 B

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

14 B

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

15 B

Murray, J. (2008). Validation of the ELISA method for 

quantitative detection of eCry3.1Ab. Report No. SSB020-08

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. SSB165-11

21 B

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

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-145-11
5307-EPA-12 Page 7 of 57

List of Accompanying Volumes (cont.)

Vol. Category1 Volume/Study 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

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

vitro digestibility of eCry3.1Ab protein under simulated 

mammalian gastric conditions. Report No. SSB-234-10

26 B

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

Nontarget Organism and Environmental Expression Data

27 B

Nelson, A. (2010). The environmental fate and effects of 

eCry3.1Ab 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

Brake, J. (2010). Evaluation of event 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 phosphomannose isomerase in broiler 

chicken diets prepared with 5307 maize grain. 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 

prepared 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.) 

 

Vol. Category1 Volume/Study 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-007-10

37 B

Spincer, D. (2009). eCry3.1Ab protein – A laboratory 

bioassay of the effects on the rove beetle, Aleochara 

bilineata (Coleoptera: Staphylinidae). Report No. SYN09-4

38 B

Vinall, S. (2009). eCry3.1Ab protein – A laboratory 

bioassay of the effects on the predatory bug, Orius 

laevigatus (Hemiptera: Anthocoridae). Report No. SYN09-2

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 Corn 

and the breeding stacks Bt11xMIR604xTC1507x5307 and 

Bt11xMIR162xMIR604xTC1507x5307 Corn. 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. 919.226.7382
5307-EPA-12 Page 9 of 57

Section I. Administrative Materials

A. Form 8570-1 – 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 Seeds, 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 protects corn roots from feeding damage caused by Diabrotica species.

PRIA category: B800 ($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. Location 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 8570-34 – 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 instructions and completing the 

necessary forms. Send comments regarding 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, 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 Triangle 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 pSYN12274

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 support (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 other 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 supported 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 submitted 

under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or 

similar composition and uses.

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

obtained 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 eligibility for 

compensation have expired for the study; (d) the study is in the public literature; (e) I have notified in writing the company 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 to 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 understand 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 acknowledge 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 8570-35 – 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 registration 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 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 Corn

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 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. Agency Internal Use Copy
 

5307-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 registration 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 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 Corn

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.

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 Copy 
 

5307-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 registration 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 Corn

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.

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 Copy
 

5307-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 registration 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 Corn

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

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. Agency Internal Use Copy 
 

5307-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 registration 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 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 Corn

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 Copy 
 

5307-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 registration 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 14

Applicant's/Registrant's Name & Address: 

Syngenta Seeds, Inc. – Field Crops - NAFTA, P.O. Box 12257, Research Triangle Park, NC 27709

Product: 5307 Corn

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. SSB020-08 Syngenta Seeds, Inc. - Field Crops OWNSubmission 

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 Copy 
 

5307-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 registration 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 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 Corn

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 Copy
 

5307-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 registration 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 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 Corn

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 eCry3.1Ab 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 environmental fate and effects of 

eCry3.1Ab 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 Copy 
 

5307-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 registration 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 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 Corn

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 Copy 
 

5307-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 registration 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 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 Corn

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

885.4240

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. SYN09-4 Syngenta Seeds, Inc. - Field Crops OWNSubmission 

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 Copy 
 

5307-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 registration 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 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 Corn

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. SYN09-2 Syngenta Seeds, Inc. - Field Crops OWNSubmission

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 Copy 
 

5307-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 registration 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 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 Corn

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 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. Agency Internal Use Copy 
 

5307-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 registration 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 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 Corn

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 17, 2009

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, 2009

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-220-10 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 Copy 
 

5307-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 registration 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 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 Corn

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 Copy 
 

5307-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 registration 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 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 Corn

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

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 Copy
 

5307-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 registration 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 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 Corn

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 Copy 
 

5307-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 registration 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 Corn

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 Copy
 

5307-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 registration 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 Corn

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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 14

Applicant's/Registrant's Name & Address: 

Syngenta Seeds, Inc. – Field Crops - NAFTA, P.O. Box 12257, Research Triangle Park, NC 27709

Product: 5307 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta Seeds, Inc. - Field Crops PL

Submission 

Volume 41

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. Public File Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

Syngenta 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 Copy 
 

5307-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 registration 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 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 Corn

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

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. Public File Copy 
 

5307-EPA-12 Page 41 of 57

Section II. Summary of the Application

A. Introduction

Using the techniques of modern molecular biology, Syngenta has transformed corn (‘maize’, 

Zea mays L.) to produce 5307 Corn, a new cultivar that is protected from root feeding 

damage caused by corn rootworms (Diabrotica sp.). Plants derived from transformation 

event 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 

phosphomannose 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 coli

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

An application for a manufacturing-use registration of a plant-incorporated protectant (PIP) 

pursuant to FIFRA §3(c)(5) is being sought for the eCry3.1Ab protein encoded by vector 

pSYN12274 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 breeding with 

other transgenic corn events containing 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 allow planting for breeding

purposes, research, agronomic testing, increasing inbred seed stocks, and producing hybrid 

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 PIPs (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 control these pests while 

reducing use of broad-spectrum soil-applied insecticides. The attendant benefits of the PIP 

rootworm-control traits on the market include higher and more consistent grain yield, 

economic benefits to growers, healthier plants, improved worker safety, and reduced use of 
 

5307-EPA-12 Page 42 of 57

fossil fuels to apply insecticide treatments. The deployment of 5307 corn, in the breeding 

combinations of Bt11×MIR604×TC1507×5307 Corn and Bt11×MIR162×MIR604×

TC1507×5307 Corn, will offer these same qualitative benefits.

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 toxic to humans and/or 

wildlife. Registration of the PIP in 5307 Corn 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 Corn alone or in the PIP breeding combinations described above.

Field studies demonstrate that the eCry3.1Ab protein in 5307 Corn 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 and Smith (Mexican corn rootworm). In the 

presence of high rootworm infestations, 5307 Corn hybrids have also demonstrated a 

significant yield advantage in side-by-side comparisons with nontransgenic, near-isogenic 

control hybrids (see Volume 42).

5307 Corn, offered in Bt11×MIR604×TC1507×5307 Corn and Bt11×MIR162×MIR604× 

TC1507×5307 Corn, 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 Corn has a unique mode 

of insecticide action1 and targets a different gut binding site in corn rootworm larvae than 

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

breeding stacks above. The concurrent deployment of both eCry3.1Ab 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 

resistance 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 conventional insecticides 

and 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 resistant 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 

eCry3.1Ab 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 rootworm control options.

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 Corn 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 listed 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-DNA 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 consisted 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 sequence 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 noncoding 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 entire 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 demonstrates that 33 bp of corn genomic 
 

5307-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 indicate 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 genomic 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 similarity 

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 Corn 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 transgenes at a single locus in the corn nuclear genome. 

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

The ecry3.1Ab and pmi genes are derived from source organisms with a history 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 sequences identified as toxins. 

PMI has no significant sequence similarity and eCry3.1Ab only exhibited significant 

sequence similarity with other Cry δ-endotoxins, as would be expected. The potential 

mammalian toxicity of both of these proteins was evaluated 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 are unlikely to occur outside fields 

where 5307 Corn 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 unlikely because there are no free-living wild relatives 
 

5307-EPA-12 Page 45 of 57

of corn in the United States and the probability that self-sustaining feral populations of 5307 

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

soil microbes are 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 persistence of bioactive 

eCry3.1Ab in soil following cultivation of 5307 Corn 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 Corn 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 dispersal 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 Corn tissues were used to 

determine estimated environmental concentrations (EECs) of eCry3.1Ab for groups of 

organisms potentially exposed via cultivation of 5307 Corn. Two sets of EECs for nontarget 

organisms (NTOs) were calculated: worst-case and conservative EECs. The worst-case 

EECs were taken as the 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 representing NTOs potentially exposed to eCry3.1Ab via cultivation of 5307 

Corn were exposed to microbially produced eCry3.1Ab or 5307 Corn tissue in the laboratory. 

These test species included three species within the order Coleoptera, the order which also 

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 worst-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 Corn. 

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 Corn, 

and provides a weight of evidence that eCry3.1Ab in 5307 Corn will have no harmful effects 

on populations of potentially exposed NTOs. Additionally, the cultivation of 5307 Corn 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: 5307 Corn

Trade name(s): none at this time

EPA registration number: 67979-__

OECD Unique Identifier: SYN-Ø53Ø7-1

Section IV. Product 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)............. 0.00034 – 0.01782%*

Other Ingredient:

Marker protein and the genetic material necessary for its production (via elements of vector 

pSYN12274) in 5307 Corn (SYN-Ø53Ø7-1) ................................................. 0.00004 – 0.00088%*

*Percent dry weight, whole plant

CAUTION

Keep Out of Reach of Children

EPA Registration Number 67979- Syngenta Seeds, Inc. – Field Crops - NAFTA

EPA Establishment Number 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 plantincorporated 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 requirements for planting of 5307 Corn.

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)............. 0.00034 – 0.01782%*

Other Ingredient:

Marker protein and the genetic material necessary for its production (via elements of vector 

pSYN12274) in 5307 Corn (SYN-Ø53Ø7-1) ................................................. 0.00004 – 0.00088%*

*Percent dry weight, whole plant

CAUTION

Keep Out of Reach of Children

EPA Registration Number 67979- Syngenta Seeds, Inc. – Field Crops - NAFTA

EPA Establishment Number 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 plantincorporated 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 requirements for planting of 5307 Corn.

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)............. 0.00034 – 0.01782%*

Other Ingredient:

Marker protein and the genetic material necessary for its production (via elements of vector 

pSYN12274) in 5307 Corn (SYN-Ø53Ø7-1) ................................................. 0.00004 – 0.00088%*

*Percent dry weight, whole plant

CAUTION

Keep Out of Reach of Children

EPA Registration Number 67979- Syngenta Seeds, Inc. – Field Crops - NAFTA

EPA Establishment Number 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 plantincorporated 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 requirements for planting of 5307 Corn.

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)............. 0.00034 – 0.01782%*

Other Ingredient:

Marker protein and the genetic material necessary for its production (via elements of vector 

pSYN12274) in 5307 Corn (SYN-Ø53Ø7-1) ................................................. 0.00004 – 0.00088%*

*Percent dry weight, whole plant

CAUTION

Keep Out of Reach of Children

EPA Registration Number 67979- Syngenta Seeds, Inc. – Field Crops - NAFTA

EPA Establishment Number 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 plantincorporated 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 requirements for planting of 5307 Corn.

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)............. 0.00034 – 0.01782%*

Other Ingredient:

Marker protein and the genetic material necessary for its production (via elements of vector 

pSYN12274) in 5307 Corn (SYN-Ø53Ø7-1) ................................................. 0.00004 – 0.00088%*

*Percent dry weight, whole plant

CAUTION

Keep Out of Reach of Children

EPA Registration Number 67979- Syngenta Seeds, Inc. – Field Crops - NAFTA

EPA Establishment Number 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 plantincorporated 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 requirements for planting of 5307 Corn.

STORAGE AND DISPOSAL

Do not contaminate bodies of water by storage or disposal. 
 

5307-EPA-12 Page 52 of 57

Section V. Satisfaction of Registration Data Requirements

Specific data requirements for obtaining registration of a PIP have not been promulgated 

under 40 CFR §174 Subpart H. In the absence of PIP-specific data requirements EPA has

utilized those requirements delineated for microbial pesticides (40 CFR §158.740) as a 

partial guide for determining if an Applicant 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 requirements are not 

published and become known to the Applicant through presubmission 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. An explanation of how each data requirement is 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 is provided in the table for those data requirements that are not applicable. The 

data requirements are organized by OCSPP Microbial Pesticide Test Guideline number, 

using the 885- guideline series. OCSPP guideline numbers are not assigned (N/A) to some 

PIP data requirements.

A. Product Analysis/Characterization Data Requirements

OPPTS # Data Requirement Method of Satisfaction

885.1100 Product identity

Volumes 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

Volumes 4 and 10

MRIDs 477347-03 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 477347-03
 

5307-EPA-12 Page 53 of 57

OPPTS # Data Requirement Method of Satisfaction

885.2250 Nature of residue in animals

No adverse effects associated with 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 plantincorporated 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 protein 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

Volumes 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-EPA-12 Page 54 of 57

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 toxicity 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 pathogenicity 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 during 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

cell 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; LD50

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 studies. 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-EPA-12 Page 55 of 57

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 Volumes 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 of exposure for eCry3.1Ab would 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 

toestuarine, or marine waters. Furthermore, 

eCry3.1Ab protein does not display a broad 

spectrum of activity. This data requirement does 

not apply.

885.4300 Nontarget 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 observed in Tier I studies 

and eCry3.1Ab is not persistent in the environment. 

Criteria needed to trigger higher tier testing are not 

met.

885.4700 Fish life cycle studies, 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.

885.4750 Aquatic ecosystem test

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.
 

5307-EPA-12 Page 56 of 57

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 Requirements

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 42
 

5307-EPA-12 Page 57 of 57

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.

Phosphomannose 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 based on temporary 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 activities is low because the acreage involved is limited. 

An IRM plan is not necessary for a manufacturing-use registration and in would be 

incompatible with some breeding and seed production uses. Adherence to an IRM plan is not 

currently required for the 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 

production 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.