TITLE

Administrative Volume for an Application for a Seed Increase Registration of the Plant-Incorporated 

Protectant, Bacillus thuringiensis Cry1F and Cry34/35Ab1 Proteins and the Genetic Material 

(PHP27118 T-DNA) Necessary for their Production in 4114 Maize 

(OECD Unique Identifier: DP-ØØ4114-3) 

DATA REQUIREMENT

40 CFR Part 174 

AUTHOR

Jamie Staley 

Pioneer Hi-Bred International, Inc. 

7100 NW 62nd Avenue 

Johnston, IA 50131 

USA

STUDY COMPLETION DATE

April 15, 2011 

STUDY NUMBER

PHI-2011-080

EPA REGISTRATION NUMBER

29964-x

Volume 1

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 1 of 100

TABLE OF CONTENTS PAGE

Statement of Data Confidentiality Claim ........................................................................................... 2 

Transmittal Document ...................................................................................................................... 4 

Section I. Administrative Materials .................................................................................................. 7 

Section II. Summary of the Application .........................................................................................73

Section III. Product Label ..............................................................................................................77

Section IV. Satisfaction of Data Requirements ............................................................................. 84

Section V. Product Characterization .............................................................................................89

Section VI. Toxicity Data ...............................................................................................................92

Section VII. Residue Data .............................................................................................................94

Section VIII. Efficacy Data .............................................................................................................95

Confidential Attachment .................................................................................................................96

Tables

Table 1. Currently Registered Maize PIPs Expressing Cry1F and/or Cry34/35Ab1 Proteins ...... 75

Table 2. Product Analysis Data Requirements ............................................................................. 84

Table 3. Residue Data Requirements ...........................................................................................84

Table 4. Toxicology Data Requirements ....................................................................................... 85

Table 5. Non-target Organism Data Requirements .......................................................................87

Table 6. Environmental Expression Data Requirements .............................................................. 88

Table 7. Mean Expression Levels of the Cry1F, Cry34Ab1 and Cry35Ab1 Proteins 

in 4114 Maize .................................................................................................................................90

Table 8. Summary of Product Characterization Data Submitted for 4114 Maize ......................... 91

Table 9. Environmental Safety Data Submitted for 4114 Maize ................................................... 93

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 3 of 100
 

TRANSMITTAL DOCUMENT

SUBMITTER

Pioneer Hi-Bred International, Inc. 

7100 NW 62nd Ave. 

Johnston, IA 50131 

REGULATORY ACTION IN SUPPORT OF WHICH THIS DOCUMENT IS SUBMITTED

Application for a New Product Registration with a Plant-Incorporated Protectant 

Pursuant to FIFRA §3(c)(5): 

Administrative Volume for an Application for a Seed Increase Registration of the Plant-Incorporated 

Protectant, Bacillus thuringiensis Cry1F and Cry34/35Ab1 Proteins and the Genetic Material 

(PHP27118 T-DNA) Necessary for their Production in 4114 Maize 

(OECD Unique Identifier: DP-ØØ4114-3) 

EPA REGISTRATION NUMBER

29964-x

TRANSMITTAL DATE

April 15, 2011 

STUDY NUMBER

PHI-2011-080

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 4 of 100
LIST OF ACCOMPANYING VOLUMES

VOL. FIFRA

10(G) VOLUME/STUDY TITLE MRID

1

A

Administrative Volume for an Application for a Seed Increase 

Registration of the Plant-Incorporated Protectant, Bacillus thuringiensis

Cry1F and Cry34/35Ab1 Proteins and the Genetic Material (PHP27118 

T-DNA) Necessary for their Production in 4114 Maize 

Staley, J. (2011). 

Study Number: PHI-2011-080 April 15, 2011 

Pages: 1-100 

C Confidential Attachment 

2 B 

Characterization of DP-ØØ4114-3 maize: Insertion integrity, stability, 

copy number, and backbone analysis 

Brink, K., and J. Weaver. (2011). 

Study Number: PHI-2009-015 April 1, 2011 

Pages: 1-48 (3 copies) 

3 B 

Equivalency of expressed proteins in 4114 maize to previously 

registered events 

Cressman, B. et al. (2011).

Study Number: PHI-2011-076 April 15, 2011 

Pages: 1-23 (3 copies) 

4 B 

Field and greenhouse insect efficacy for 4114 maize 

Nowatzki, T. et al. (2011).

Study Number: PHI-2011-077 April 8, 2011 

Pages: 1-31 (3 copies) 

5 B 

Environmental Risk Assessment for the cultivation of maize containing 

event DP-ØØ4114-3 (4114 maize) 

Califf, K. et al. (2011).

Study Number: PHI-2011-078 April 18, 2011 

Pages: 1-39 (3 copies) 

6 B 

Trait Durability Plan supporting a Seed Increase Registration for 4114 

maize

Binning, R. et al. (2011).

Study Number: PHI-2011-079 April 14, 2011 

Pages: 1-9 (3 copies) 

7 B 

Western blot analysis of maize lines containing event DP-ØØ4114-3 

and combined trait product DAS-Ø15Ø7-1xDAS-59122-7

Sult, T and P. Utley. (2011). 

Study Number: PHI-2011-067 April 15, 2011 

Pages: 1-15 (3 copies) 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 5 of 100

SECTION I. ADMINISTRATIVE MATERIALS

A.1. Letter of Authorization (Data Access Letter) from Dow AgroSciences LLC 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 7 of 100
Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 8 of 100
 

A.2. EPA Form 8570-1: Application for Pesticide Registration 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 9 of 100

 

A.3. EPA Form 8570-4: Confidential Statement of Formula

See CBI Cross Reference Number 1 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 11 of 100
 

A.4. EPA Form 8570-34: Certification with Respect to Citation of Data

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 12 of 100

A.5. EPA Form 8570-35: Data Matrix for 4114 Maize 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 14 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 1 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in cornGuideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Acute oral toxicity in mice: Cry1F Bacillusthuringiensis subsp. aizawai delta endotoxin 44691101 68467 PEREffectiveness data for Bacillus thuringiensis var. 

aizawai Cry1F insect control protein as expressed in maize 44691102 68467 PER

Background document on resistance management 44691103 68467 PERProduct characterization data for Bacillusthuringiensis var. aizawai: Cry1F insect control 

protein as expressed in maize 44714801 68467 PER

Characterization of gene inserts – Bacillusthuringiensis aizawai: Cry1F control protein as 

expressed in maize 44714802 68467 PER

Equivalency of microbial and maize expressed Cry1F protein; characterization of test substances for biochemical and toxicological studies. In vitro digestibility of microbial and maize expressed Cry1F protein under simulated gastric conditions 44714803 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 15 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 2 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Quantitative ELISA analysis of Cry1F expression and PAT expression levels in maize MPS inbred and hybrid lines 1360, 1365, 1366 and 1369 (interim report) 44714804 68467 PERComparison of the amino acid sequence similarity of Cry1F and PAT proteins to KnPER allergen protein 44971701 68467 PERMicrobial B.t. Cry1F (truncated) delta-endotoxin: Maize-insect-pest susceptibility study 45020101 68467 PERCharacterization of inserted genes in Cry1F maize line 1507 45020102 68467 PERCharacterization of expressed Cry1F protein in maize tissues (pollen, grain, grain-containing feed and purified maize-expressed Cry1F protein) and microbial expressed Cry1F delta-endotoxin by biological and biochemical procedures 45020103 68467 PER

Quantitative ELISA analysis of Cry1F and PAT expression levels in and compositional analysis of maize inbred and hybrid line 1362 and 1507 45020104 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 16 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 3 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Environmental fate of Cry1F protein incorporated into soil 45020105 68467 PERCry1F Bacillus thuringiensis var. aizawai delta 

endotoxin: an acute toxicity study with the earthworm in an artificial soil substrate 45020106 68467 PER

Chronic exposure of Folsomia candida to bacterially 

expressed Cry1F protein 45020107 68467 PER

OECD 202 

B.t. Cry1F delta endotoxin: A 48-hour static-renewal acute toxicity test with the Cladoceran (Daphniamagna) using bacterially expressed B.t. Cry1F delta endotoxin, and pollen from maize expressing B.t.Cry1F delta endotoxin 45020108 68467 PER

885.4340

Cry1F Bacillus thuringiensis var. aizawai delta 

endotoxin: A dietary study with green lacewing larvae 45020109 68467 PER

885.4340

Cry1F Bacillus thuringiensis var. aizawai delta 

endotoxin: A dietary study with the ladybird beetle 45020110 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 17 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 

29964-x Page 4 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic (PHP27118 T-DNA) material necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 885.4340

Cry1F Bacillus thuringiensis var. aizawai delta 

endotoxin: A dietary toxicity study with parasitic hymenoptera 45020111 68467 PER

71-2

Transgenic corn expressing Bacillus thuringiensis 

var. aizawai (B.t.) Cry1F delta endotoxin: A dietary toxicity study with Northern bobwhite 45020112 68467 PER

Field survey of beneficial arthropods associated with Bacillus thuringiensis Cry1F maize 45020113 68467 PEREfficacy of Cry1F events TC1360 and TC1507 45020114 68467 PERCry1F binding studies 45020115 68467 PERResistance management plan for transgenic maize expressing the Cry1F insecticidal protein from Bacillus thuringiensis var. aizawai 45020116 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 18 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 5 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Supplement to MRID 44714801: Supplemental data - Product characterization data for Bacillusthuringiensis var. aizawai: Cry1F control protein as expressed in maize 45020117 68467 PERSupplement to MRID 44691101: Supplemental data - Acute oral toxicity in mice: Bacillus thuringiensis var. aizawai Cry1F delta endotoxin 45020118 68467 PERPhosphinothricin acetyltransferase (PAT) protein: In vitro digestibility study 45041501 68467 PERNon-target exposure and risk assessment for environmental dispersal of Cry1F maize pollen 45041502 68467 PEREvaluation of the dietary effect(s) on honeybee development using bacterially expressed B.t. Cry1F delta endotoxin and pollen from maize expressing B.t. Cry1F delta endotoxin 45041503 68467 PERWaiver request: Fish toxicity test with transgenic maize (corn) containing Bacillus thuringiensis var. 

aizawai(B.t.) Cry1F delta endotoxin 45044201 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 19 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 6 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

High dose demonstration of Cry1F events TC1360 and TC1507: European corn borer 45131101 68467 PER

Toxicity of the Cry1F protein to neonate larvae of the monarch buttefly (Danaus plexippus (Linneaus)) 45131102 68467 PER

Public interest document for Cry1F-protected corn 45131103 29964 OWN

Thermolability of Cry1F (truncated) delta endotoxin 45274801 68467 PERCompositional analysis of maize MPS hybrid line 1507 45274802 68467 PERCry1F lateral flow test kit procedure for analyzing Cry1F corn grain 45279301 68467 PERMethod validation report for the determination of Cry1F delta endotoxin protein in grain by EnzymeLinked Immunosorbent Assay 45279302 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 20 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 7 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Public interest document for Cry1F protected corn 45298101 29964 OWNSupplement to MRID 45131102: Supplemental data - High dose demonstration of Cry1F events TC1360 and TC1507: European corn borer 45307701 68467 PERWaiver request: Fish toxicity test to assess the potential effects of maize containing Bacillusthuringiensis var. aizawai (Bt) Cry1F insecticidal 

protein (ICP) in native fish 45307702 68467 PER

Supplement to MRID 45020109: Cry1F Bacillusthuringiensis var. aizawai delta endotoxin: A dietary toxicity study with green lacewing larvae 45307801 68467 PERSupplement to MRID 45020110: Cry1F Bacillusthuringiensis var. aizawai delta endotoxin: A dietary toxicity study with green ladybird beetle 45307802 68467 PER

Supplement to MRID 45020111: Cry1F Bacillusthuringiensis var. aizawai delta endotoxin: A dietary toxicity study with parasitic hymenoptera 45307803 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 21 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 8 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Supplement to MRID 45020106: Cry1F Bacillusthuringiensis var. aizawai delta endotoxin: An acutetoxicity study with the earthworm in an artificial soil substrate 45307804 68467 PERSupplement to MRID 45041503: Evaluation of the dietary effect(s) on honeybee development using bacterially expressed B.t. Cry1F delta endotoxin and 

pollen from maize expressing B.t. Cry1F delta endotoxin 45307805 68467 PER

Supplement to MRID 45298101: Supplemental data - Public interest document for Cry1F protected corn 45309401 29964 OWN

Exposure and risk assessment of Herculex I Bt field corn pollen to Karner blue butterfly 45512901 68467 PERNutritional equivalency of B.t. Cry1F maize - poultry feeding study 45622001 68467 PER

Field survey of beneficial arthropods associated with Bacillus thuringiensis Cry1F maize 45648001 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 22 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 9 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Field surveys of non-target invertebrate populations in B.t. corn 45652001 68467 PERDevelopment and characterization of EnzymeLinked Immunosorbent Assay (ELISA) for detection of Cry1F protein 45685601 68467 PER

Independent laboratory validation of method GRM 02.13, determination of Cry1F delta endotoxin protein in corn grain by an of Enzyme-Linked Immunosorbent Assay 45685602 68467 PERSupplement to MRID 45131102: Toxicity of the Cry1F protein to neonate larvae of the monarch butterfly (Danaus plexippus (Linneaus)) 45759701 68467 PER

Stewardship of Herculex I Insect Protection with respect to the secondary lepidopteran pest, western bean cutworm (Richia albicosta Smith) 45896601 29964 OWNLack of cross reactivity between Cry1F protein in Herculex I maize and the dust mite Der p7 protein with human sera positive for Der p7-IgE 46444001 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 23 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 10 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Monitoring the susceptibility of European corn borer to Cry1Ab and Cry1F Bt proteins: Results from the 2004 collections and diapausing larvae collected in 2003 46583101 80778 PERStewardship of event TC1507 maize with respect to the secondary lepidopteran pests lesser corn stalk borer (Elasmopalpus lignosellus Zeller), southern 

corn stalk borer (Diatraea crambidiodes Grote), and 

sugarcane borer (Biatraea saccharalis Fabricius) 46600201 68467 PER

Slide presentation summarizing European corn borer and Cry1F resistance monitoring update 46695801 68467 PERInsect resistance management compliance assurance program report for corn borer-protected Bt corn 46747801 80778 PER

Field surveys of non-target invertebrate populations in Bt corn: Supplement to MRID No. 45652001 46784601 80778 PERMonitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2005 monitoring results 46874901 80778 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 24 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 11 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Research results on 2004 European corn borer collections from Hamilton County, Iowa: Cry1F 47011201 68467 PERInsect resistance management compliance assurance program report for corn borer-protected Bt corn, corn rootworm-protected Bt corn, and corn borer/corn rootworm protected stacked Bt corn 47044401 80778 PER

Monitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2006 monitoring results 47118401 80778 PERSoil accumulation of Cry1F after three years of cropping with Herculex 1 corn 47120701 68467 PER

TC1507 maize and fall armyworm in Puerto Rico 47176001 68467 PERProposed revisions to IRM-related registration requirements for Cry1 plant-incorporated protectants in field corn 47407001 80778 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 25 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 12 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Monitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2007 monitoring results 47413901 80778 PERProposed revisions to IRM-related registration requirements for Cry1 plant-incorporated protectants in field corn 47543901 80778 PER

Monitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2008 monitoring results 47841801 80778 PERMonitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2009 monitoring results 47971001 80778 PER

Product characterization data for Bacillusthuringiensis PS149B1 13.6 kDa and 43.8 kDa insecticidal crystal proteins expressed in transgenic maize plants 45242201 68467 PEREquivalency of microbial and maize-expressed PS149B1 proteins 45242203 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 26 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 13 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Microbial PS149B1 binary delta endotoxin: Maizeinsect-pest susceptibility study 45242204 68467 PERComparison of the amino acid sequence of the Bacillus thuringiensis strain PS149B1 13.6 kDa and 43.8 kDa insecticidal crystal proteins to KnPER protein allergens 45242205 68467 PER

Characterization of Pseudomonas produced and transgenic maize expressed phosphinothricin acetyltransferase (PAT) protein 45242206 68467 PER

PS149B1 14 kDa protein: Acute oral toxicity study in CD-1 mice 45242207 68467 PER

PS149B1 44 kDa protein: Acute oral toxicity study in CD-1 mice 45242208 68467 PER PS149B1 14 kDa and 44 kDa proteins: Acute oral toxicity study in CD-1 mice 45242209 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 27 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 14 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

PS149B1 binary insecticidal crystal protein: A dietary toxicity study with ladybird beetle 45242210 68467 PER The tri-trophic interaction between PS149B1 transformed maize, corn leaf aphid and ladybird beetle 45242211 68467 PERIn vitro digestibility of PS149B1 proteins 45242212 68467 PERQuantitative ELISA analysis of PS149B1 protein expression levels in hybrid and inbred lines of maize event TC5639 (interim report) 45242213 68467 PER

Degradation of microbial binary PS149B1 delta endotoxin in a representative soil from the midWestern USA maize growing region 45242214 68467 PER

Product durability plan for transgenic maize expressing insecticidal crystal protein from Bacillusthuringiensis strain PS149B1 during the experimental use period 45242215 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 28 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 15 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Field efficacy of PS149B1 maize events against corn rootworms 45242216 68467 PER Microbial PS149B1 binary insecticidal crystal proteins, pollen expressing PS149B1 binary insecticidal crystal proteins, and individual PS149B1 14 kDa and 44 kDa insecticidal crystal proteins on honeybee development 45340701 68467 PER

Thermolability of PS149B1 binary delta endotoxin 45358401 68467 PER

PS149B1binary insecticidal crystal protein: Acute toxicity study to the earthworm in an artificial substrate 45360201 68464 PER

Lateral flow test kit method validation for the detection of the PS149B1 14 kDa and 44 kDa protein in maize grain 45383401 68467 PERHeat lability of individual proteins of the PS149B1 binary ICP 45584501 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 29 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 16 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the (PHP27118 T-DNA) genetic material necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

In vitro simulated gastric fluid digestibility study of microbially derived Cry34Ab1 protein 45584502 68467 PER 

Characterization of Cry34Ab1 and Cry35Ab1 from recombinant Pseudomonas fluorescens and 

transgenic maize 45790401 68467 PER

Characterization of DNA inserted into transgenic corn events (Cry34Ab1 and Cry35Ab1) 45790402 68467 PER

PS149B1 binary insecticidal crystal protein: An 8-day dietary study with rainbow trout, Oncorhynchus mykiss Wallbaum 45790403 68467 PERPS149B1 binary insecticidal crystal protein: Acute toxicity study with Daphnid, Daphnia magna Straus 45790404 68467 PER 

PS149B1 binary insecticidal crystal protein: Dietary toxicity to parasitic hymenoptera (Nasoniavitripennis) 45790405 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 30 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 17 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Assessment of the chronic toxicity of diet containing Bacillus thuringiensis PS149B1 insecticidal crystal protein to collembolan (Folsomia candida) 45790406 68467 PER PS149B1 binary insecticidal crystal protein: Dietary toxicity to green lacewing (Chrysoperla carnea) 45790407 68467 PER SDS-PAGE sensitivity analysis for Cry35Ab1 in support of the simulated gastric fluid digestibility study MRID 45242212 45790408 68467 PER

Trait durability and experimental use of transgenic maize expressing the insecticidal crystalline proteins Cry34Ab1and Cry35Ab1 45790509 68467 PERField efficacy of Cry34Ab1/Cry35Ab1 maize events against corn rootworms 45790410 68467 PER

Product characterization data for Bacillusthuringiensis Cry34Ab1 and Cry35Ab1 proteins expressed in transgenic maize plants (PHP17658) 45790501 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 31 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 18 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Product characterization data for Bacillusthuringiensis Cry34Ab1 and Cry35Ab1 proteins expressed in transgenic maize plants (PHP17662) 45790601 68467 PERSummary heat lability studies with Cry34Ab1/ Cry35Ab1 45808601 68467 PERQuantitative ELISA analysis of Cry34Ab1 and Cry35Ab1 proteins expressed in maize plants transformed with the vector PHP17658 45833101 68467 PER

Quantitative ELISA analysis of Cry34Ab1 and Cry35Ab1 proteins expressed in maize plants transformed with the vector PHP17662 45833102 68467 PERSlide presentation summarizing Cry34Ab1/ Cry35Ab1 heat inactivation studies 45860201 68467 PER

Probe MOA studies to assess potential for protein synthesis inhibition by Bacillus thuringiensisPS149B1 Cry34Ab1/Cry35Ab1 proteins in rabbit reticulocyte assay: Re-examination of lab notebook data 45942801 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 32 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 19 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Product characterization data for Bacillusthuringiensis Cry34Ab1 and Cry35Ab1 proteins expressed in transgenic maize plants (PHP17662) 46030001 68467 PERPublic interest document for Cry34/35Ab1 corn rootworm-protected corn 46122701 29964 OWNIndependent laboratory validation Pioneer Hi-Bred International, Inc. ELISA method for the quantification of Cry34Ab1 protein from transgenic plants 46123901 68467 PERIndependent laboratory validation of Dow AgroSciences method GRM 03.13, “ Determination of Cry35Ab1 insecticidal crystal protein in maize tissue by Enzyme-Linked Immunosorbent Assay” 46123902 68467 PER

Cry34/35 protein distribution and familiarity 46123903 68467 PER

Agronomic characteristics, quantitative ELISA and nutrient composition analysis of hybrid maize lines containing cry34Ab1, cry35Ab1 and pat genes: Chile locations 46123904 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 33 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 20 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Biological equivalency of Cry34/35Ab1 insecticidal crystal protein in transgenic plants derived from transgenic Pseudomonas flourscens 46123905 68467 PER Characterization of Cry34Ab and Cry35Ab1 proteins derived from transgenic maize event E4497.59.1.22 (DAS-59122-7) 46123906 68467 PERCharacterization of phosphinothricin acetyltransferase (PAT) derived from transgenic maize event E4497.59.1.22 46123907 68467 PERCharacterization of DNA inserted into transgenic corn events DAS-45216-6 and DAS-59122-7 46123908 68467 PER

Detailed characterization of DNA into transgenic corn events DAS-45216-6 and DAS-59122-7 46123909 68467 PEREvaluation of microbe derived Cry34Ab1 and Cry35Ab1 proteins for protein synthesis inhibition activity 46123910 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 34 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 21 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Nutritional equivalency study of maize containing Cry34Ab1 and Cry35Ab1: Poultry feeding study 46123911 68467 PERThe effect of Cry34Ab1/Cry35Ab1 proteins on the development and mortality of the ladybird beetle Coleomegilla maculata DeGeer 46123912 68467 PERNon-target invertebrate ecological risk assessment for field corn expressing Cry34Ab1 and Cry35Ab1 insecticidal crystal proteins in event DAS-59122-7 46123913 68467 PEREvaluation of the impact corn rootworm control strategies on non-target arthropods 46123914 68467 PER

Investigations into dose of Cry34Ab1/Cry35Ab1 rootworm-resistant maize event DAS-59122-7 against western and northern corn rootworms in support of trait durability plans 46123915 68467 PEREffect on western corn rootworm adults feeding on Cry34/35Ab1 corn rootworm-protected corn tissue and implication for product durability 46123916 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 35 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 22 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Evaluation of endangered/threatened insect species relative to the use of Cry34/35Ab1 corn rootwormresistant maize hybrids 46123917 68467 PERTrait durability plan for Cry34/35 corn rootworm protected corn event DAS-59122-7 following commercialization 46123918 68467 PERSimulations of corn rootworm adaptation to Cry34/35 corn rootworm protected corn in support of trait durability plans for event DAS-59122-7 46123919 68467 PER

Digestion of allergenic and non-allergenic proteins in simulated gastric fluid 46123920 68467 PERDigestion efficiency of allergens and non-allergens in simulated gastric fluid: Bacillus thuringiensisCry34/35Ab1 construct PHP17662 46388601 68467 PERLack of Cry34Ab1/Cry35Ab1 co-association in solution 46556801 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 36 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 23 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Summary report of a carabid beetle laboratory toxicity study using Cry34Ab1 and Cry35Ab1 including copies of references 46714101 68467 PERDetailed resistance monitoring plan for Cry34/35Ab1 corn event DAS-59122-7 47334201 68467 PEREvaluation of potential dietary effects of Cry34/35Ab1 protein on insidious flower bugs, Orius insidiosus (Hemiptera: Anthocoridae) 47436701 68467 PERMonitoring corn rootworm susceptibility to Cry34/35Ab1 event DAS-59122-7: 2007 insect collections 47522501 68467 PERMonitoring corn rootworm susceptibility to Cry34/35Ab1 event DAS-59122-7: 2008 insect collections 47900801 68467 PER

Soil accumulation of Cry34Ab1 and Cry35Ab1 proteins after three years of cropping with DAS59122-7 corn 47959501 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 37 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 24 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the (PHP27118 T-DNA) genetic material necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Three-year field monitoring of Cry34/35Ab1 and Cry1FxCry34/35Ab1 maize hybrids for non-target arthropod effects 47870301 68467 PERInvestigating performance of HerculexTM RW and HerculexTM XTRA under commercial use 48045501 68467 PERMonitoring corn rootworm susceptibility to Cry34/35Ab1 event DAS-59122-7: 2009 growing season 48279701 68467 PER

Summary information in support of the Section 3 registration of 1507x59122 corn 46297101 68467 PER 

Characterization of a stacked hybrid of transgenic corn lines DAS-01507-1 and DAS-59122-7 by comparison to the individual lines 46297102 68467 PERAgronomic characteristics, quantitative ELISA and nutrient composition analysis of hybrid corn lines containing cry1F, cry34Ab1, cry35Ab1 and pat genes: US and Canada locations 46297103 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 38 of 100
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: April 15, 2011 EPA Reg. No. / File Symbol: 29964-x Page 25 of 29Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Amended report: Agronomic characteristics, quantitative ELISA and nutrient composition analysis of hybrid corn lines containing cry1F, cry34Ab1, cry35Ab1 and pat genes: US and Canada locations 46343801 68467 PERNutritional equivalency study of stacked hybrid of transgenic corn line 1507 (event DAS-01507-1) and 59122 (event DAS-59122-7): Poultry feeding study 46343803 68467 PERComparison of insect efficacy and expression in Cry34/35 corn events DAS-59122-7 and DAS59132-8 expressed as a single and a stack with DAS-01507-1 46343804 68467 PERField efficacy of Herculex XTRA (DAS-01507-1xDAS-59122-7) insect resistant corn 46343805 68467 PERInvestigation of potential interaction between Cry1F and the binary Cry34Ab1/Cry35Ab1 proteins 46343806 68467 PERThe effect of corn pollen expressing the Cry1F and Cry34Ab1/Cry35Ab1 proteins on the development and mortality of the ladybird beetle Coleomegilla maculata DeGeer 46343807 68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 39 of 100
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: April 15, 2011 EPA Reg. No. / File Symbol: 29964-x Page 26 of 29Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Laboratory bioassay assessment of corn pollen protein (Cry34/35 and Cry1F, stacked transgenes), and their effect on the larvae of monarch butterfly 46343808 68467 PEREquimolar ratio of Cry1F (tr) + Cry35Ab1 + Cry34Ab1: Acute oral toxicity study in CD-1 mice 46384301 68467 PERComparison of the amino acid sequence identity between the Cry1F protein and known protein allergens 47786401 29964 OWNComparison of the amino acid sequence identity between the Cry34/35 proteins and known protein allergens 47786402 29964 OWNComparison of the amino acid sequence identity between the PAT protein and known protein allergens 47786403 29964 OWNEvaluation of the amino acid sequence similarity of the Cry1F protein to the NCBI protein sequence datasets 47786405 29964 OWN

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 40 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 27 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Evaluation of the amino acid sequence similarity of the PAT protein to the NCBI protein sequence datasets 47786407 29964 OWNEvaluation of the amino acid sequence similarity of the Cry34/35Ab1 proteins to the NCBI protein sequence datasets 47786408 29964 OWNMonitoring corn rootworm susceptibility to event DAS-59122-7 using the sub-lethal seedling assay: 2009 growing season 48309902 29964 OWNMonitoring the susceptibility of corn lepidopteran pests to Cry1Ab and Cry1F proteins: 2009 monitoring results 47971001 80778 PERMonitoring corn rootworm susceptibility to Cry34/35Ab1 event DAS-59122-7: 2009 growing season 48279701 68467 PERCharacterization of DP-ØØ4114-3 maize: Insertion integrity, stability, copy number and backbone analysis Submitted 29964 OWN

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 41 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 28 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Equivalency of expressed proteins in 4114 maize to previously registered events Submitted 29964 OWN Field and greenhouse insect efficacy for 4114 maize Submitted 29964 OWNEnvironmental Risk Assessment for the cultivation of maize containing event DP-ØØ4114-3 (4114 maize) Submitted 29964 OWNTrait Durability Plan supporting a Seed Increase Registration for 4114 maize Submitted 29964 OWNWestern blot analysis of maize lines containing event DP-ØØ4114-3 and combined trait product DAS-Ø15Ø7-1xDAS-59122-7 Submitted 29964 OWNExpressed Trait Protein Concentration of a Maize Line Containing Events DP-ØØ4114-3, DAS-Ø15Ø7-1, DAS-59122-7, and Combined Trait Product DAS-Ø1507-1xDAS-59122-7: US and Canada Test Sites Submitted 29964 OWN

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 42 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 29 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131 

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

Literature references supporting a Seed Increase Registration for 4114 maize Submitted 29964 OWN

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 43 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 1 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Public File Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 44 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 2 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 45 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 3 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 46 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 4 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER68467 PER68467 PER68467 PER68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 47 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 5 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 48 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 6 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 29964 OWN 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 49 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 7 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

29964 OWN 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 50 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 8 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 29964 OWN 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 51 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 9 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER68467 PER29964 OWN68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 52 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 10 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

80778 PER 68467 PER 68467 PER 80778 PER 80778 PER 80778 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 53 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 11 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 80778 PER 80778 PER 68467 PER 68467 PER 80778 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 54 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 12 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

80778 PER 80778 PER 80778 PER 80778 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 55 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 13 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 56 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 14 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 57 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 15 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 58 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 16 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 59 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 17 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 60 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 18 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 61 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 19 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 29964 OWN 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 62 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 20 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 63 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 21 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 64 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 22 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 65 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 23 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER68467 PER68467 PER68467 PER68467 PER

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 66 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 24 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 67 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 25 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 68467 PER 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 68 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 26 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

68467 PER 68467 PER 29964 OWN 29964 OWN 29964 OWN 29964 OWN 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 69 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 27 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

29964 OWN 29964 OWN 29964 OWN 80778 PER 68467 PER 29964 OWN 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 70 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 28 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

29964 OWN29964 OWN29964 OWN29964 OWN29964 OWN29964 OWN 

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy 

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 71 of 100
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: April 15, 2011

EPA Reg. No. / File Symbol: 29964-x Page 29 of 29

Applicant's/Registrant's Name & Address:Pioneer Hi-Bred International, Inc., 7100 NW 62nd Avenue, Johnston, IA 50131

Product:4114 Maize 

Ingredient Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the genetic material (PHP27118 T-DNA) necessary for their production in corn Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note 

29964 OWN

Signature Name and Title 

Jamie Staley U.S. Registration Manager 

DateApril 15, 2011 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version Public File Copy

Pioneer Hi-Bred International, Inc.Study Number: PHI-2011-080 Page 72 of 100
SECTION II. SUMMARY OF APPLICATION

Pioneer Hi-Bred International, Inc. (Pioneer) is requesting a Seed Increase Registration for a plantincorporated protectant (PIP) containing Pioneer’s new active ingredient Bacillus thuringiensis Cry1F and 

Cry34/35Ab1 insecticidal proteins and the genetic material necessary for their production (via elements of 

vector PHP27118) in event 4114 maize (Organization for Economic Cooperation and Development 

[OECD] Unique Identifier DP-ØØ4114-3). 4114 maize will not be sold or planted commercially for the 

purposes of grain production and controlling corn insect pests. 4114 maize will be used only for breeding 

purposes, agronomic testing, increasing inbred seed, and producing hybrid seed on a limited amount of 

acreage per county and per year. 4114 maize will be used to create inbred lines that can be crossed with 

other inbred lines to create hybrid maize products with multiple modes of action for control of pest insects. 

The new PIP, 4114 maize, produces its own insecticidal proteins within the corn plant. The insecticidal 

proteins were derived from Bacillus thuringiensis (Bt), a naturally occurring soil bacterium. The Cry1F 

and Cry34/35Ab1 insecticidal proteins expressed in 4114 maize control certain lepidopteran and corn 

rootworm pests of corn, respectively. 

4114 maize is a new genetic event that is a “molecular stack” (DNA inserted at one locus in maize 

genome) of the previously registered “breeding stack” (DAS-Ø15Ø7-1 x DAS-59122-7; EPA registration 

29964-5). The Cry1F, Cry34/35Ab1 and PAT proteins expressed in 4114 maize are identical to those 

expressed in 1507 (EPA Registration 29964-3), 59122 (EPA Registration 29964-4) and/or 1507x59122 

maize. Cry1F, Cry34/35Ab1 and PAT have tolerance exemptions at EPA and are components of 

commercial Bt maize products currently being grown on a large number of U.S. corn acres. 

A. Use Profile 

Active Ingredient Name: Bacillus thuringiensis Cry1F and Cry34/35Ab1 insecticidal proteins and the 

genetic material necessary for their production (via elements of vector 

PHP27118) in Event 4114 maize (OECD Unique Identifier DP-ØØ4114-3) 

Trade and Other Name(s): 4114 Maize 

OPP Chemical Codes: 006481 (Cry1F corn) and 006490 (Cry34/35Ab1 corn)

Basic Manufacturer: Pioneer Hi-Bred International, Inc. 

7300 NW 62nd Ave. 

Johnston, IA 50131 

Type of Pesticide: Plant-Incorporated Protectant 

Uses: Seed Increase in Field Corn 

Target Pests for 4114 maize: Black cutworm (Agrotis ipsilon), corn earworm (Helicoverpa zea),

European corn borer (Ostrinia nubilalis), fall armyworm (Spodoptera frugiperda), Southwestern corn 

borer (Diatraea grandiosella), western bean cutworm (Striacosta albicosta), lesser corn stalk borer 

(Elasmopalpus lignosellus), southern corn stalk borer (Diatraea crambidoides), sugarcane borer 

(Diatraea saccharalis), western corn rootworm (Diabrotica virgifera virgifera), northern corn rootworm 

(Diabrotica barberi), and Mexican corn rootworm (Diabrotica virgifera zeae).

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 73 of 100
B. Regulatory History 

4114 maize is a new genetic event containing previously approved active ingredients in the same crop 

(field corn). No Experimental Use Permit (EUP) application for event 4114 maize was submitted. 4114 

maize has been grown in small-scale field tests under the 10-acre EUP exemption, as described in 40 

CFR §172.3(c)(1). 

4114 maize is also regulated by the United States Department of Agriculture-Animal and Plant Health and 

Inspection Service, Biotechnology Regulatory Services (USDA-APHIS BRS). A petition for deregulation 

of 4114 maize is being submitted to USDA-APHIS BRS in the third quarter of 2011. A safety and 

nutritional assessment of 4114 maize will also be submitted to the Food and Drug Administration’s Center 

for Food Safety and Applied Nutrition (FDA CFSAN) in a similar time period. 

4114 maize was developed by Agrobacterium-mediated transformation of corn using the DNA plasmid 

vector PHP27118. The T-DNA of PHP27118 contains the cry1F, cry34Ab1, cry35Ab1 and pat genes.

4114 maize produces two Bacillus thuringiensis (Bt) proteins, Cry1F and Cry34/35Ab1. The Cry1F 

protein confers resistance to certain lepidopteran pests, including the European corn borer (Ostrinia

nubilalis). The Cry34Ab1 and Cry35Ab1 proteins together comprise an active insecticidal crystal protein 

that confers resistance to certain coleopteran pests, including western corn rootworm (Diabrotica virgifera 

virgifera). The PAT protein confers tolerance to the herbicidal active ingredient glufosinate-ammonium. 

4114 maize is a single transformation event that is intended to replace the previously registered breeding 

stack DAS-Ø15Ø7-1 (1507 maize) x DAS-59122-7 (59122 maize); EPA registration number 29964-5.

1507 and 59122 maize are also individually registered (EPA registrations 29964-3 and 29964-4, 

respectively). 

The Cry1F and Cry34/35Ab1 proteins in 4114 maize are identical to the Cry1F and Cry34/35Ab1 proteins 

in 1507 and 59122 maize, respectively. The Cry1F and Cry34/35Ab1 proteins are components of many 

registered maize PIP products (Table 1). The Cry1F protein in 1507 and 4114 maize is from the 

requirement of a tolerance in maize (40CFR §174.520). The Cry34/35Ab1 protein from 59122 and 4114 

maize is also exempt from the requirement of a tolerance in maize (40CFR §174.506). In addition, the 

PAT protein in 1507, 59122 and 4114 maize is exempt from the requirement of a tolerance in all plants 

(40CFR §174.522). A summary of the regulatory history is as follows: 

On April 11, 1997 (62 FR No. 70), in response to a petition from Dekalb Genetics Corporation, EPA 

established a permanent exemption from the requirement of a tolerance for phosphinothricin 

acetyltransferase (PAT) in all plant raw agricultural commodities.

On June 6, 2001 (66 FR No. 109), in response to a petition from Mycogen Seeds c/o Dow AgroSciences 

LLC, EPA established a permanent exemption from the requirement of a tolerance for Cry1F in the food 

and feed commodities of field corn, sweet corn and pop corn.

On July 7, 2003 (68 FR No. 129), in response to a petition from Mycogen Seeds c/o Dow AgroSciences 

LLC, EPA established a time-limited exemption from the requirement of a tolerance for Cry34/35Ab1 in 

the food and feed commodities of field corn, sweet corn and pop corn. 

On September 21, 2005 (70 FR No. 182), in response to a petition from Mycogen Seeds c/o Dow 

AgroSciences LLC, EPA established a permanent exemption from the requirement of a tolerance for 

Cry34/35Ab1 in the food and feed commodities of field corn, sweet corn and pop corn. 

On April 25, 2007 (72 FR 20435), the tolerance exemptions for the PAT, Cry1F, and Cry34/35Ab1 

proteins were redesignated from 40 CFR §180 to 40 CFR §174. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 74 of 100
Table 1. Currently Registered Maize PIPs Expressing Cry1F and/or Cry34/35Ab1 Proteins 

EPA Reg. 

Number Registration Name Company Active Ingredient(s)

Initial Date of 

Registration

29964-3

TC1507 

(Herculex I) 

Pioneer Hi-Bred Int’l, Inc. 

Cry1F May 18, 2001 

68467-2 Mycogen Seeds (c/o Dow 

Agrosciences LLC) 

29964-4

DAS-59122-7

(Herculex Rootworm) 

Pioneer Hi-Bred Int’l, Inc. 

Cry34/35Ab1 August 31, 2005 

68467-5 Mycogen Seeds (c/o Dow 

Agrosciences LLC) 

68467-6 TC1507 x DAS-59122-7 

(Herculex XTRA) 

Mycogen Seeds (c/o Dow 

Agrosciences LLC) Cry1F 

Cry34/35Ab1 October 27, 2005 

29964-5 Pioneer Hi-Bred Int’l, Inc. 

68467-4 DAS-06275-8 Mycogen Seeds (c/o Dow 

Agrosciences LLC) Cry1F May 27, 2005 

29964-6 Optimum AcreMax 1 Pioneer Hi-Bred Int’l, Inc. Cry1F 

Cry34/35Ab1 April 30, 2010 

29964-7 TC1507 x MON810 

(Optimum Intrasect) Pioneer Hi-Bred Int’l, Inc. Cry1Ab Cry1F February 24, 2010 

29964-8 TC1507 x DAS-59122-7 x 

MON810 Pioneer Hi-Bred Int’l, Inc. 

Cry1Ab 

Cry1F 

Cry34/35Ab1 

February 24, 2010 

29964-9 DAS-59122-7 x MON810 Pioneer Hi-Bred Int’l, Inc. Cry1Ab 

Cry34/35Ab1 February 24, 2010 

29964-10 Optimum AcreMax RW Pioneer Hi-Bred Int’l, Inc. Cry34/35Ab1 April 30, 2010 

524-581 MON 89034 x TC1507 x 

MON 88017 x DAS-59122-7 

(SmartStax) 

Monsanto Company Cry1A.105 

Cry2Ab2 

Cry1F 

Cry3Bb1 

Cry34/35Ab1 

July 20, 2009 

68467-7 Mycogen Seeds (c/o Dow 

Agrosciences LLC) 

524-584 MON 89034 x DAS-59122-7* Monsanto Company 

Cry1A.105 

Cry2Ab2 

Cry34/35Ab1 

December 14, 

2009

524-586 MON 88017 x DAS-59122-7* Monsanto Company Cry3Bb1 

Cry34/35Ab1 

December 14, 

2009

524-588 MON 89034 x TC1507 x 

DAS-59122-7* Monsanto Company 

Cry1A.105 

Cry2Ab2 

Cry1F 

Cry34/35Ab1 

December 14, 

2009

524-589 MON 89034 x MON 88017 x 

DAS-59122-7* Monsanto Company 

Cry1A.105 

Cry2Ab2 

Cry3Bb1 

Cry34/35Ab1 

December 14, 

2009

524-590 TC1507 x MON 88017 x 

DAS-59122-7* Monsanto Company 

Cry1F 

Cry3Bb1 

Cry34/35Ab1 

December 14, 

2009

*Note: Registration is for breeding purposes, agronomic testing, increasing inbred seed stocks, and 

producing hybrid seed only.

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 75 of 100
C. Benefits of 4114 Maize 

The corn seed industry is transitioning from Bt products with a single mode of action to products with 

multiple modes of action, in order to extend the durability of important Bt traits that many growers rely on 

to manage pests. In addition, growers are requiring an increasingly sophisticated suite of traits to meet 

their changing farming needs, which include transgenic herbicide resistance as well as native traits such 

as disease tolerance, drought tolerance, and higher yields.

Furthermore, as new transgenic traits are developed to provide improved nutrition or agronomic 

performance, growers will continue to demand multiple Bt traits for protection against pest damage in 

addition to the new traits. It is imperative for growers to continue to increase their overall farm 

productivity to meet the food security needs of a growing global population. 4114 maize, as one 

component of future Bt breeding stack products with multiple modes of action, will provide benefits to 

growers in the form of multi-trait products with enhanced durability, higher yields and more diverse 

germplasm suited for diverse growing regions. 

Corn breeders have suspected for some time that there is a finite number of transgenic events that can 

be combined in one maize plant before starting to reduce the plant’s agronomic performance and yield. 

Precise quantitative data on the yield impact of multiple transgenic events in a maize product are 

impossible to obtain, primarily due to the much larger variation in yield due to the specific genetic 

background of the maize hybrid and the exact environment in which it grows. 4114 maize is a “molecular 

stack” of Cry1F and Cry34/35Ab1 in one transgenic event. It will replace the previously registered 

“breeding stack” of 1507x59122 (Cry1F and Cry34/35Ab1 in separate transgenic events), thereby 

reducing the number of events in complex breeding stacks of multiple traits. 

Breeding multiple traits in one maize product becomes increasingly complex and expensive with each 

breeding locus added. In 4114 maize, the cry1F and cry34/35Ab1 genes are at one locus in maize 

genome, whereas in 1507x59122, the cry1F and cry34/35Ab1 genes are at separate loci. Molecular 

stacks such as 4114 maize reduce the number of loci required for insect traits, thus increasing the speed 

at which new high-yielding products are available to growers. For example, the effort required to breed 

two transgenic loci into multiple elite inbred lines is double the effort required for one transgenic locus. In 

addition, each trait (locus) must be in a homozygous state in inbreds. Based on simple Mendelian 

segregation of multiple loci that do not segregate together (as is the case with unlinked traits in breeding 

stacks), the proportion of plants that are homozygous for all traits of interest becomes smaller with each 

trait added, resulting in more seed discard during the breeding process.

4114 maize is expected to be able to be bred into a much wider variety of maize genetic backgrounds 

than 1507x59122, thus giving growers more choice in high-yielding products offering in-plant insect 

production as well as more products customized to their local growing areas and agronomic needs 

D. Nature of Registration Being Requested 

An application for a Seed Increase Registration of plant-incorporated protectants pursuant to FIFRA 

§3(c)(5) is being sought for Bacillus thuringiensis Cry1F and Cry34/35Ab1 proteins and the genetic 

material (PHP27118 T-DNA) necessary for their production in 4114 maize. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 76 of 100
SECTION III. PRODUCT LABEL

Three (3) copies of the label for 4114 maize are attached.

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 77 of 100
4114 Maize 

(OECD Unique Identifier: DP-ØØ4114-3) 

Active Ingredients:

Bacillus thuringiensis Cry1F protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0015%*

Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0064%*

Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0100%*

Inert Ingredients:

Phosphinothricin acetyltransferase (PAT) protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn events DP-ØØ4114-3 .......................................................... <0.0011%*

* Percentage (wt/wt) on a dry wt. basis for whole plant 

KEEP OUT OF REACH OF CHILDREN 

CAUTION

NET CONTENTS ________________ 

EPA REGISTRATION NUMBER: 29964-xx 

EPA ESTABLISHMENT NUMBER: 029964-IA-001 

Pioneer Hi-Bred International, Inc. 

7300 NW 62nd Avenue 

Johnston, IA 50131 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 78 of 100
DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in any manner inconsistent with its labeling. 

This plant-incorporated protectant (PIP) may be combined through conventional breeding with other 

registered plant-incorporated 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. 

4114 maize may be used for breeding purposes, agronomic testing, increasing inbred seed and 

producing hybrid seed corn up to a total of 20,000 acres per county and up to a combined United States 

(U.S.) total of 250,000 acres per plant-incorporated protectant active ingredient per registrant per year.

Commercial plantings of this product for the purposes of grain production and controlling corn insect 

pests are prohibited.

Use Pattern 

Crop Pests 

Field corn black cutworm 

corn earworm 

European corn borer 

fall armyworm 

lesser corn stalk borer 

southern corn stalk borer 

southwestern corn borer 

sugarcane borer 

stalk borer 

western bean cutworm 

western corn rootworm 

northern corn rootworm 

Mexican corn rootworm 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 79 of 100
4114 Maize 

(OECD Unique Identifier: DP-ØØ4114-3) 

Active Ingredients:

Bacillus thuringiensis Cry1F protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0015%*

Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0064%*

Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0100%*

Inert Ingredients:

Phosphinothricin acetyltransferase (PAT) protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn events DP-ØØ4114-3 .......................................................... <0.0011%*

* Percentage (wt/wt) on a dry wt. basis for whole plant. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION

NET CONTENTS ________________ 

EPA REGISTRATION NUMBER: 29964-xx 

EPA ESTABLISHMENT NUMBER: 029964-IA-001 

Pioneer Hi-Bred International, Inc. 

7300 NW 62nd Avenue 

Johnston, IA 50131 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 80 of 100
DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in any manner inconsistent with its labeling. 

This plant-incorporated protectant (PIP) may be combined through conventional breeding with other 

registered plant-incorporated 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. 

4114 maize may be used for breeding purposes, agronomic testing, increasing inbred seed and 

producing hybrid seed corn up to a total of 20,000 acres per county and up to a combined United States 

(U.S.) total of 250,000 acres per plant-incorporated protectant active ingredient per registrant per year.

Commercial plantings of this product for the purposes of grain production and controlling corn insect 

pests are prohibited.

Use Pattern 

Crop Pests 

Field corn black cutworm 

corn earworm 

European corn borer 

fall armyworm 

lesser corn stalk borer 

southern corn stalk borer 

southwestern corn borer 

sugarcane borer 

stalk borer 

western bean cutworm 

western corn rootworm 

northern corn rootworm 

Mexican corn rootworm 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 81 of 100
4114 Maize 

(OECD Unique Identifier: DP-ØØ4114-3) 

Active Ingredients:

Bacillus thuringiensis Cry1F protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0015%*

Bacillus thuringiensis Cry34Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0064%*

Bacillus thuringiensis Cry35Ab1 protein and the genetic material (PHP27118 T-DNA)

necessary for its production in corn event DP-ØØ4114-3 ............................................................ <0.0100%*

Inert Ingredients:

Phosphinothricin acetyltransferase (PAT) protein and the genetic material (PHP27118 T-DNA) 

necessary for its production in corn events DP-ØØ4114-3 .......................................................... <0.0011%*

* Percentage (wt/wt) on a dry wt. basis for whole plant. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION

NET CONTENTS ________________ 

EPA REGISTRATION NUMBER: 29964-xx 

EPA ESTABLISHMENT NUMBER: 029964-IA-001 

Pioneer Hi-Bred International, Inc. 

7300 NW 62nd Avenue 

Johnston, IA 50131 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 82 of 100
DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in any manner inconsistent with its labeling. 

This plant-incorporated protectant (PIP) may be combined through conventional breeding with other 

registered plant-incorporated 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. 

4114 maize may be used for breeding purposes, agronomic testing, increasing inbred seed and 

producing hybrid seed corn up to a total of 20,000 acres per county and up to a combined United States 

(U.S.) total of 250,000 acres per plant-incorporated protectant active ingredient per registrant per year.

Commercial plantings of this product for the purposes of grain production and controlling corn insect 

pests are prohibited.

Use Pattern 

Crop Pests 

Field corn black cutworm 

corn earworm 

European corn borer 

fall armyworm 

lesser corn stalk borer 

southern corn stalk borer 

southwestern corn borer 

sugarcane borer 

stalk borer 

western bean cutworm 

western corn rootworm 

northern corn rootworm 

Mexican corn rootworm 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 83 of 100
SECTION IV. SATISFACTION OF DATA REQUIREMENTS

Specific data requirements for obtaining registration of a plant-incorporated protectant (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 §158.2120) as a partial 

guide for determining if an Applicant has provided all of the 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 became known to the 

Applicant through previous consultations with the Agency.

The tables in this section provide a listing of the data requirements applicable to registration of a plantincorporated protectant as known to Pioneer. 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 OPPTS Microbial 

Pesticide Test Guideline number, using the 885- guideline series. OPPTS guideline numbers are not 

assigned (N/A) to some PIP data requirements. 

Table 2. Product Analysis Data Requirements 

OPPTS # Data Requirement Method of Satisfaction 

885.1100 Product identity 

CSF (PHI-2011-080), Volume 2 (PHI-2009-015), 

MRID 447148-03, 450201-03, 457904-01, 461239-03, 

461239-05, 461239-06, 452422-06, 461239-07,

885.1200 Manufacturing process Volume 2 (PHI-2009-015) 

885.1300

Formation of unintentional 

ingredients

MRID 477864-01, 447864-05, 477864-02, 477864-08, 

477864-03, 477864-07,

885.1400 Analysis of samples Volume 8 (PHI-2010-059) 

885.1500 Certification of limits CSF (PHI-2011-080) and Volume 8 (PHI-2010-059) 

Table 3. Residue Data Requirements 

OPPTS # Data Requirement Method of Satisfaction 

885.2100 Chemical identity CSF (PHI-2011-080) and Volume 8 (PHI-2010-059) 

885.2200 Nature of residue in plants CSF (PHI-2011-080) 

885.2250

Nature of residue in 

animals

No adverse effects associated with mammalian 

exposure to Cry1F, Cry34/35Ab1, or the PAT protein 

have been observed; thus they are not of toxicological 

concern and do not trigger this data requirement. 

885.2300 Analytical methods - plants 

Volume 8 (PHI-2010-059), MRID 452793-01 and 

453834-01

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 84 of 100
OPPTS # Data Requirement Method of Satisfaction 

885.2350

Analytical methods - 

animals

Cry1F, Cry34/35Ab1, and the PAT proteins in 4114 

maize are exempt from the requirement of tolerances, 

thus an analytical enforcement method is not needed. 

885.2400 Storage stability 

Cry1F, Cry34/35Ab1, and the PAT proteins in 4114 

maize are exempt from the requirement of tolerances, 

thus storage stability data is not needed 

885.2500

Magnitude of residues in 

plants Volume 8 (PHI-2010-059) 

885.2550

Magnitude of residues in 

meat, milk, poultry, and 

eggs

Cry1F, Cry34/35Ab1, and the PAT proteins in 4114 

maize are exempt from the requirement of tolerances; 

thus residue studies are not required. 

885.2600

Magnitude of residues in 

potable water, fish, and 

irrigated crops 

The Cry1F, Cry34/35Ab1, and PAT proteins are plantincorporated and will not be used in aquatic sites.

4114 maize 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 4114 maize; thus, aquatic residue studies 

are not required. 

Table 4. Toxicology Data Requirements 

OPPTS # Data Requirement Method of Satisfaction 

885.3050

Acute oral 

toxicity/pathogenicity

MRID 446911-01, 450201-18, 452422-07, 452422-08, 

452422-09 and 436843-01 

885.3100

Acute dermal 

toxicity/pathogenicity

The Cry1F, Cry34/35Ab1, and PAT proteins are plantincorporated, contained within individual plant cells.

There is minimal opportunity for human dermal 

contact because corn is not a hand harvested crop.

Furthermore, Cry1F, Cry34/35Ab1, and PAT proteins 

are of no toxicological concern; thus, dermal toxicity 

data are not required. As the proteins are not living 

organisms, a pathogenicity determination is not 

applicable.

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 85 of 100
OPPTS # Data Requirement Method of Satisfaction 

885.3150

Acute pulmonary 

toxicity/pathogenicity

The Cry1F, Cry34/35Ab1, and PAT proteins are plantincorporated and are not volatile. There is minimal 

opportunity for human inhalation exposure. The 

proteins are of no toxicological concern; thus, 

inhalation toxicity data are not required. As the 

proteins are not a living organism, a pathogenicity 

determination is not applicable. 

885.3200

Acute injection 

toxicity/pathogenicity

The Cry1F, Cry34/35Ab1, and PAT proteins are plantincorporated and of no toxicological concern. There is 

minimal opportunity for direct entry of the proteins into 

the blood stream via injury during handling because 

corn is not a hand-harvested crop. As the proteins 

are not living organisms, a pathogenicity 

determination is not applicable. 

885.3400 Hypersensitivity incidents 

Pioneer is aware of no incidents of hypersensitivity 

reactions to Cry1F, Cry34/35Ab1, or PAT protein in 

4114 maize. 

885.3500 Cell culture 

Cry1F, Cry34/35Ab1 and PAT are not living 

organisms and therefore, have no infectivity potential.

A cell culture study is not required. 

885.3550 Acute toxicology, Tier II 

No adverse effects were observed at the maximum 

attainable oral doses for Cry1F, Cry34/35Ab1, and 

PAT; LD50 determinations are therefore, not possible.

Criteria needed to trigger this Tier II study were not 

met in the Tier I studies. 

885.3600

Subchronic

toxicity/pathogenicity

No evidence of infectivity, pathogenicity, or toxicity 

was observed in Tier I studies with Cry1F, 

Cry34/35Ab1, and PAT in 4114 maize. Criteria 

needed to trigger this Tier II study were not met in Tier 

I studies. 

885.3650 Reproductive/fertility effects 

No evidence of infectivity, pathogenicity, or toxicity 

was observed in Tier I studies with Cry1F, 

Cry34/35Ab1, and PAT in 4114 maize. Criteria 

needed to trigger this Tier II study were not met in Tier 

I studies. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 86 of 100
Table 5. Non-target Organism Data Requirements 

OPPTS # Data Requirement Method of Satisfaction 

885.4050 Avian oral, Tier I 

MRID 450201-12, 456220-01, 461239-11, and 

463438-03.

885.4100 Avian inhalation, Tier I 

The Cry1F, Cry34/35Ab1, and PAT proteins are plantincorporated and are not ‘applied’ in aerosol or dust 

formulations as microbial pesticide products would be.

The only airborne route of exposure for Cry1F, 

Cry34/35Ab1, and PAT proteins would be via pollen 

drift, and corn pollen is not of a size that is respirable. 

885.4150 Wild mammal testing, Tier I 

MRID 446911-01, 450201-18, 452422-07, 452422-08, 

452422-09, and 463843-01.

885.4200

Freshwater fish testing, Tier 

I MRID 450442-01, 453077-02, and 457904-03. 

885.4240

Freshwater aquatic 

invertebrate testing, Tier I MRID 450201-08 and 457904-04 

885.4280

Estuarine and marine 

animal testing, Tier I 

There will be no ‘direct application’ of Cry1F, 

Cry34/35Ab1, and PAT proteins to fresh, estuarine, or 

marine waters. Furthermore, Cry1F, Cry34/35Ab1, 

and PAT proteins do not display broad spectrums of 

activity. This data requirement does not apply. 

885.4300

Nontarget plant studies, 

Tier I 

Cry1F, Cry34/35Ab1, and PAT are not living 

organisms and therefore, are not pathogenic to plants. 

885.4340

Non-target insect testing, 

Tier I 

MRID 450201-07, 450201-09, 450201-10, 450201-11, 

451311-02, 453078-01, 453078-02, 453078-03, 

455129-01, 457597-01, 452422-10, 457904-05, 

457904-06, 457904-07, 461239-12, 467141-01, 

474367-01, 463438-08, and 463438-09 

885.4380 Honey bee testing, Tier I MRID 450415-03, 453078-05, and 453407-01 

885.4600

Avian chronic pathogenicity 

and reproduction test, Tier 

III

No adverse effects were observed in Tier I studies 

and Cry1F, Cry34/35Ab1, and PAT proteins are not 

persistent in the environment. Criteria needed to 

trigger higher tier testing are not met. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 87 of 100
OPPTS # Data Requirement Method of Satisfaction 

885.4650

Aquatic invertebrate range 

testing, Tier III 

No adverse effects were observed in Tier I studies 

and Cry1F, Cry34/35Ab1, and PAT proteins are 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 Cry1F, Cry34/35Ab1, and PAT proteins are 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 Cry1F, Cry34/35Ab1, and PAT proteins are not 

persistent in the environment. Criteria needed to 

trigger higher tier testing are not met. 

N/A

Other non-target organism 

tests 

MRID 450201-06, 450201-13, 450415-02, 453078-04, 

456482-01, 456520-01, 467846-01, 452422-11, 

453602-01, 461239-13, 461239-14, 461239-17, and 

478477-01.

Table 6. Environmental Expression Data Requirements 

OPPTS # Data Requirement Method of Satisfaction 

885.5200

Expression in a terrestrial 

environment

MRID 450201-05, 471207-01, 452422-14, and 

479595-01.

885.5300

Expression in a freshwater 

environment

Cry1F, Cry34/35Ab1, and PAT protein in 4114 maize 

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 

Cry1F, Cry34/35Ab1, and PAT protein in 4114 maize 

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. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 88 of 100
SECTION V. PRODUCT CHARACTERIZATION

4114 maize was created using Agrobacterium-mediated transformation of a select maize line. The 

plasmid PHP27118 was used to produce this event. The T-DNA region of plasmid PHP27118 

incorporated into 4114 maize contained the cry1F, pat, cry34Ab1 and cry35Ab1 genes and the regulatory 

sequences necessary for their expression. The regulatory elements (as well as the coding sequences) 

for the cry1F, pat, cry34Ab1 and cry35Ab1 genes in 4114 maize are identical to those in 1507 and/or 

59122 maize. 

A. Transformation System 

Immature embryos of maize (Zea mays L.) were aseptically removed from the developing caryopsis nine 

to eleven days after pollination and inoculated with Agrobacterium tumefaciens strain LBA4404 

containing plasmid PHP27118, essentially as described in Zhao et al., 2001. After three to six days of 

embryo and Agrobacterium co-cultivation on solid culture medium with no selection, the embryos were 

then transferred to a medium without herbicide selection but containing carbenicillin for selection against 

Agrobacterium. After three to five days on this medium, embryos were then transferred to selective 

medium that was stimulatory to maize somatic embryogenesis and contained bialaphos for selection of 

cells expressing the pat transgene. The medium also contained carbenicillin to select against any 

remaining Agrobacterium. After six to eight weeks on the selective medium, healthy, growing calli that 

demonstrated resistance to bialaphos were identified. The putative transgenic calli were subsequently 

regenerated to produce T0 plantlets. 

B. Characterization of the DNA Inserted in the Plant and Inheritance and Stability 

Samples were taken from the T0 plantlets for PCR analysis to verify the presence and copy number of 

the PHP27118 T-DNA by screening for the cry1F, cry34Ab1, cry35Ab1, and/or pat genes. In addition to 

this analysis, the T0 plantlets were analyzed for the presence of certain Agrobacterium binary vector 

backbone sequences by PCR. Plants that were determined to be single copy for the inserted genes and 

negative for vector backbone sequences were selected for further greenhouse propagation. These 

selected T0 plants were additionally screened to confirm trait efficacy. The T0 plants meeting all PCR 

and trait efficacy criteria, including maize event 4114, were advanced and crossed to inbred lines to 

produce seed for further testing.

Subsequent characterization of the DNA isolated from maize line 4114 using restriction enzyme digests 

and southern blots indicated that the T-DNA from plasmid PHP27118 was integrated as a single 

insertion. In addition, DNA analysis indicated stability and inheritance of the inserted DNA within and 

across several generations. The Southern blot analysis also confirmed that 4114 maize does not contain 

plasmid vector backbone DNA (Volume 2; PHI-2009-015). 

C. Analytical Detection Methods 

Validated methods for extraction and direct ELISA analysis of Cry1F, Cry34Ab1 and Cry35Ab1 in corn 

grain have been previously submitted and found acceptable by the Agency (MRIDs 45279302, 46123901 

and 46123902, respectively). 

D. Bridging Protein Equivalency/Identity 

The Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins expressed in 4114 maize are identical to the proteins 

expressed in the previously registered 1507, 59122 and/or 1507x59122 maize products (Volume 3: PHI2010-076). This equivalency was established as follows: 

The same gene expression cassettes (promoters, protein coding sequences and terminators) 

were used in 4114 maize as in previously registered 1507 and 59122 maize, so all genetic 

elements are identical. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 89 of 100
Western blot analysis demonstrated the Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins in 4114 

maize migrate with the equivalent molecular weight as and have similar relative immunoreactivity 

to the proteins expressed in previously registered 1507x59122 maize, indicating equivalency. 

The inserted DNA in 4114 maize was sequenced and the translated amino acid sequences of the 

encoded Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins were determined. The translated amino 

acid sequences were compared to the amino acid sequence of those proteins in previously 

registered 1507, 59122 and 1507x59122 maize and found to be identical. 

Bioequivalency of the expressed Cry1F and Cry34/35Ab1 proteins was established via side-byside efficacy testing of 4114 maize with 1507x59122 maize. 

The expressed proteins in 4114 maize are identical to proteins expressed in previously registered 

products. Therefore, previously submitted safety data and full tolerance exemptions for Cry1F, 

Cry34Ab1, Cry35Ab1 and PAT proteins are also applicable for 4114 maize.

E. Bridging Protein Expression 

In order to measure and compare the concentrations of Cry1F, Cry34/35Ab1 and PAT proteins in 4114 

maize to previously registered products, tissue samples were collected from field-grown plants at five 

locations in the United States and Canada (Volume 8; PHI-2010-059). 

Expression levels of Cry1F, Cry34Ab1, Cry35Ab1, and PAT protein were measured in various tissues 

(including leaf, root, whole plant, pollen, stalk, forage and grain) from 4114 maize, 1507 maize, 59122 

maize, 1507x59122 maize, and near isoline control maize using specific quantitative ELISA methods.

For each protein, the concentrations in each 4114 maize tissue were statistically compared to the 

concentrations in 1507, 59122, and 1507x59122 maize in order to determine the statistical significance of 

any differences. 

The expression levels of Cry1F protein in 4114 maize were comparable to or lower than levels in 1507 

maize and 1507x59122 maize in all tissues measured except for pollen and late-season leaf tissues.

Concentrations of Cry1F in pollen and late-season leaf tissues were significantly higher in 4114 maize. 

The expression levels of Cry34Ab1 protein in 4114 maize were comparable to or lower than levels in 

59122 maize and 1507x59122 maize in all tissues measured except for late-season leaf tissue. The 

concentration of Cry34Ab1 in late-season leaf tissue was significantly higher in 4114 maize. 

The expression levels of Cry35Ab1 protein in 4114 maize were comparable to or lower than levels in 

59122 maize and 1507x59122 maize in all tissues measured. 

The expression levels of PAT protein in 4114 maize were comparable to or higher than levels in 1507 

maize and were comparable to or lower than levels in 59122 maize and 1507x59122 maize. 

Table 7. Mean Expression Levels of the Cry1F, Cry34Ab1 and Cry35Ab1 Proteins in 4114 Maizea

Tissue

(ng/mg tissue dry weight)b

Cry1F Cry34Ab1 Cry35Ab1 

Leaf 2.0-34 19-110 27-90 

Root 3.8-5.5 17-23 6.4-13 

Whole Plantc 4.1-12 23-52 21-76 

Pollen 35 9.2 0.34 

Stalk 6.0 25 9.1 

Grain 3.3 24 1.1 

a Summarized from PHI-2010-059 (Volume 8) 

b

 Ranges reflect the range of means at different growth stages. 

c

 Whole plant ranges include forage 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 90 of 100
Table 8. Summary of Product Characterization Data Submitted for 4114 Maize 

Study Title Summary Study No. 

Characterization of 

DP-ØØ4114-3

Maize Insertion 

Integrity, Stability, 

Copy Number and 

Backbone Analysis 

Southern blot analyses indicate that 4114 maize has the 

introduced DNA inserted in the corn genome at a single locus 

and contains one copy each of the cry1F, cry34Ab1,

cry35Ab1 and pat expression cassettes. All expression 

elements are shown to be present in the insert, and there are 

no other elements detectable other than those associated 

with the respective cassettes. No backbone sequences from 

plasmid PHP27118 were detected in the 4114 maize 

genome.

PHI-2009-015

(Volume 2) 

Equivalency of 

Expressed Proteins 

in 4114 Maize to 

Previously

Registered Events 

The Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins 

expressed in 4114 maize are identical to the proteins 

expressed in the previously registered 1507, 59122 and/or 

1507x59122 maize products. This equivalency was 

confirmed by use of the same genetic elements, Western blot 

analysis, translated amino acid sequence of the DNA insert, 

and insect efficacy. 

PHI-2010-076

(Volume 3) 

Equivalency of 

Expressed Proteins 

in 4114 Maize to 

Previously

Registered Events 

Western blot analysis of 4114 and 1507x59122 leaf tissue 

demonstrated equivalency between the Cry1F, Cry34Ab1, 

Cry35Ab1 and PAT proteins. The translated amino acid 

sequence of the 4114 maize DNA insert showed 100% 

identity of the Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins 

in 4114 maize with the previously published amino acid 

sequences of those proteins. 

PHI-2011-067

(Volume 7) 

Expressed Trait 

Protein

Concentration of a 

Maize Line 

Containing Events 

DP-ØØ4114-3,

DAS-Ø15Ø7-1,

DAS-59122-7, and 

Combined Trait 

Product DASØ1507-1xDAS59122-7: US and 

Canada Test Sites 

The expression levels of Cry1F protein in 4114 maize were 

comparable to or lower than levels in 1507 maize and 

1507x59122 maize in all tissues measured except for pollen 

and late-season leaf tissues. Concentrations of Cry1F in 

pollen and late-season leaf tissues were significantly higher in 

4114 maize. The expression levels of Cry34Ab1 protein in 

4114 maize were comparable to or lower than levels in 59122 

maize and 1507x59122 maize in all tissues measured except 

for late-season leaf tissue. The concentration of Cry34Ab1 in 

late-season leaf tissue was significantly higher in 4114 maize.

The expression levels of Cry35Ab1 protein in 4114 maize 

were comparable to or lower than levels in 59122 maize and 

1507x59122 maize in all tissues measured. 

PHI-2010-059

(Volume 8)

References

Zhao, Z., Gu, W., Cai, T., Tagliani, L., Hondred, D., Bond, D., Schroeder, S., Rudert, M. and Pierce, D. 

2001. High throughput genetic transformation mediated by Agrobacterium tumefaciens in maize. 

Molecular Biology 8: 323-333. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 91 of 100
SECTION VI. TOXICITY DATA

A. Human Health Assessment of 4114 Maize 

Quantitative expression analysis of 4114 maize grain demonstrates that Cry1F, Cry34/35Ab1 and PAT 

protein concentrations are comparable to concentrations in grain of 1507, 59122 and/or 1507x59122 

maize (Volume 8; PHI-2010-059). Western blots of plant extracts and DNA sequence data of the 4114 

maize insert demonstrate that the Cry1F and Cry34/35Ab1 proteins expressed in 4114 maize are 

identical to those produced in 1507, 5912 and/or 1507x59122. 4114 maize is a replacement event for 

1507x59122 maize; overall acreage of Cry1F and Cry34/35Ab1 is not expected to increase because of 

the availability of 4114 maize as a product component. Therefore, the exposure to Cry1F and 

Cry34/35Ab1 in human and animal diets due to the incorporation of products containing 4114 maize is 

not expected to increase over current levels. Since the proteins and exposure are identical to previous 

events, the tolerance exemptions and human health assessments conducted for 1507 and 59122 maize 

are applicable to 4114 maize. The tolerance exemptions for Cry1F; Cry34/35Ab1 and PAT proteins are 

as follows: 

Cry1F protein is exempt from the requirement of a tolerance in corn: 40CFR §174.520. 

Cry34Ab1 and Cry35Ab1 proteins are exempt for the requirement of a tolerance in corn: 40CFR 

§174.506.

Phosphinothricin acetyltransferase (PAT) is exempt from the requirement of a tolerance in all 

plants: 40CFR §174.522. 

There is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population, 

including infants and children, to the Cry1F and Cry34/35Ab1 proteins and the genetic material necessary 

for their production (as expressed in 4114 maize). This includes all anticipated dietary exposures. No 

toxicity to mammals has been observed, nor any indication of allergenicity potential for Cry1F or 

Cry34/35Ab1.

B. Endocrine Disruptors 

The pesticidal active ingredients Cry1F and Cry34/35Ab1 are proteins, derived from sources that are not 

known to exert an influence on the endocrine system. 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening 

Program (EDSP) to determine whether certain substances (including pesticide active and other 

ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally 

occurring estrogen, or other such endocrine effects as the Administrator may designate.” Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected 

based on the potential for human exposure through pathways such as food and water, residential activity, 

and certain post-application agricultural scenarios. 

The Cry1F and Cry34/35Ab1 insect control proteins (as expressed in 4114 maize) are not among the 

group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. 

C. Potential for Cry1F and Cry34/35Ab1 Interactions 

Herman and Storer (2004) tested for an interaction between Cry1F and Cry34/35Ab1 when they were 

combined in artificial diet bioassays using sensitive insect species. No synergism or antagonism between 

Cry1F and Cry34/35Ab1 was seen in the tests. Therefore, the absence of antagonistic or synergistic 

effects in sensitive organisms makes it extremely unlikely that the Cry1F x Cry34/35Ab1 proteins 

produced in Herculex® XTRA (EPA Reg. No: 29964-5) will have any adverse effect on non-target 

organisms different from what was seen in individual Cry protein testing (BPPD 2010). These data and 

conclusions are equally applicable to 4114 maize. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 92 of 100
D. Environmental Assessment of 4114 Maize (Volume 5) 

Pioneer has requested a seed increase registration for 4114 maize containing Bacillus thuringiensis 

Cry1F and Cry34/35Ab1 proteins and the genetic material necessary for their production in all corn lines 

and varieties. The pat selectable marker gene was used in the transformation process, and the PAT 

protein confers tolerance to the herbicidal active ingredient glufosinate-ammonium. 

The Cry proteins expressed in 4114 maize are intended, when combined in future products with other Bt

traits to provide multiple modes of action, to control the lepidopteran pests such as European corn borer 

(ECB, Ostrinia nubilalis), corn earworm (CEW, Helicoverpa zea), fall armyworm (FAW, Spodoptera

frugiperda), and black cutworm (BCW, Agrotis ipsilon), and coleopteran pests such as western corn 

rootworm (Diabrotica virgifera virgifera) and northern corn rootworm (Diabrotica barberi). These are all 

pests of corn in the United States. These pests feed on various parts of the corn plant, including the base 

of seedlings and on the stalk, leaf, and ear tissue of corn plants. They can destroy the entire plant, 

weaken the stalk, and/or damage the ear. In areas where one or more of these pests is prevalent, 

significant financial losses are realized from decreased corn yields and increased expenditures on 

chemical pest control agents, including organophosphate, carbamate and pyrethroid insecticides. 

Pioneer has conducted an environmental risk assessment of Cry1F and Cry34/35Ab1 when expressed in 

4114 maize (Volume 5; PHI-2011-078). General topics covered in this assessment include: 

specificity of Cry1F and Cry34/35Ab1 to target insect pests; 

fate of Cry1F and Cry34/35Ab1 in the soil environment; 

exposure assessment to soil dwelling organisms, predators, and pollen feeders; 

hazard assessment of 4114 maize to soil ecology and function, soil-dwelling organisms, nontarget lepidoptera, non-target coleoptera, and other non-target organisms; 

impact on wildlife; and 

gene flow to related wild plants and its potential effects. 

Because the concentration of Cry1F in 4114 maize pollen is ~1.5 times that of Cry1F in 1507 or 

1507x59122 (Volume 8; PHI-2010-059), special consideration was given in the environmental risk 

assessment to the impact of 4114 maize on non-target and beneficial organisms. 

Table 9. Environmental Safety Data Submitted for 4114 Maize 

Study Title Summary Study No. 

Environmental Risk 

Assessment for the 

Cultivation of Maize 

Containing Event DPØØ4114-3 (4114 

maize)

The risk of 4114 maize cultivation resulting in adverse 

effects on non-target organisms and wildlife is expected to 

be low, based on a comprehensive risk assessment which 

includes exposure and hazard assessments. 

PHI-2011-078

(Volume 5)

References

Herman, R and N. Storer. 2004. Investigation of potential interaction between Cry1F and the binary 

Cry34Ab1/Cry35Ab1 proteins. MRID 463438-06 

BPPD 2010. Biopesticides Registration Action Document: Bacillus thuringiensis Cry34Ab1 and 

Cry35Ab1 Proteins and the Genetic Material Necessary for Their Production (PHP17662 T-DNA) in Event 

DAS-59122-7 Corn (OECD Unique Identifier: DAS-59122-7). September 2010. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 93 of 100
SECTION VII. RESIDUE DATA

No Codex maximum residue levels exist for the plant-pesticides Bacillus thuringiensis Cry1F or 

Cry34/35Ab1 proteins and the genetic material necessary for their production in corn. Furthermore, EPA 

has established an exemption from the requirement of a tolerance for Cry1F, Cry34/35Ab1 and PAT 

proteins. Therefore, not residue data is required for 4114 maize. 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 94 of 100
SECTION VIII. EFFICACY DATA 

Insect efficacy data of 4114 maize against key target pests are provided in Volume 4 (PHI-2011-077).

The results demonstrate that efficacy of 4114 maize is comparable with 1507x59122 maize against ECB, 

SWCB, FAW, CRW, and BCW. 4114 maize is expected to have activity against the same pest spectrum 

as 1507x59122 maize.

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 95 of 100
CONFIDENTIAL ATTACHMENT 

{CBI Cross Reference Number 1} 

EPA Form 8570-4

Confidential Statement of Formula

The Certified Limits presented in the attached CSFs represent the highest and lowest levels of 

individual proteins measured during the course of studies on events or event combinations for 

each plant tissue type. No entries are being made for the Nominal Concentration (column 13) of 

each protein because their levels vary significantly by tissue type and by growth stages of the 

plants. There is not an expected amount of each ingredient in a typical plant sample.

Pioneer is proposing a set of non-standard Certified Limits as allowed under 40 CFR § 

158.175(c). These proteins are plant-incorporated protectants or marker proteins produced by 

the plant, not in a traditional closely monitored and controlled manufacturing facility. Multiple 

factors beyond the control of the Applicant could influence the levels of these proteins 

synthesized by individual plants, including but not limited to environmental conditions, plant 

growth stage, and the presence of biotic or abiotic stressors. For these reasons, the Applicant is 

not providing the Certification required by 40 CFR § 158.175(e). 

Pioneer Hi-Bred International, Inc.

Study Number: PHI-2011-080 Page 96 of 100