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This Document Is the Property of Bayer AG And/Or Any of Its Affiliates. It and and regime. AG Bayer property protectionpublishing of contents its parties.data therefore and/oror affiliates. property intellectualthird may its as the of and is regulatory owner. a document any such its reproductiondocument owner this of under of rightsthe this documentand/or rights to of fall use of the This may distribution,and rights owner subject Food and Feed Safety and Nu be the violate copy of Conclusion Based on Data and Information Evaluated According to FDA’s Policy and may documentpublication, Lepidopteran-protected Corn MON 89034 It exploitation this (OECD Unique Identifier MON-89Ø34-3) any permission prohibited the be commercial on Foods from New Plant Varieties Furthermore,any tritional Assessment of the Consequently,without October 13, 2006 FDA BNF No. 00105 Monsanto 06-CR-161F Prepared by: Contributors Monsanto Company FDA BNF No. 00105 / Monsanto 06-CR-161F : Submitted by: 800 NorthMonsanto Lindbergh Company Blvd. St. Louis, MO 63167 Page 1 of 323 and and regime. AG Bayer property protectionpublishing of contents its parties.data therefore and/oror affiliates. property intellectualthird may its as the of and is regulatory owner. a document any such its reproductiondocument owner this of PART I: CERTIFICATIO under of this and/orrights the document fall of rights to of use PART I: CERTIFICATION, CONTENTS AND SUMMARY .....................................2 the This may distribution,and Table of Contents .............................................................................................................. rights owner subject List of Tables ...................................................................................................................7 the violate List of Figures ...................................................................................................................8 be copy of Certification .................................................................................................................11 and may documentpublication, Release of Information....................................................................................................12N, CONTENTS AND SUMMARY It exploitation Table of Contents Abbreviations, Acronyms and Definitions......................................................................13 this any Narrative Summary .........................................................................................................19 permission prohibited PART II: SYNOPSIS OF CONSULTATION SUMMARY .......................................25 the commercial be SECTION 1. Name and Address of the Submitter.........................................................25 SECTION 2. The subject of this Summary and the Plant Species from which They Furthermore,any Consequently,without SECTION 3. Distinctive Designations Gi SECTION 4. Identity and Sources of SECTION 5. The Intended Technicalwere Derived...........................................................................................25 Effect of MON 89034........................................26 SECTION 6. The Applications and Uses of MON 89034 .............................................27 SECTION 7. Applications for which MON 89034 is not Suitable................................30 MON 89034 ............................................................................................25 References .................................................................................................................31 PART III: STATUS OF SUBM SECTION 1. Status of Submission to USDA-APHIS ...................................................34 SECTION 2. Status of Submission to U.S. EPA ...........................................................34 AGENCIES.....................................................................................................34the Geneticven Materialto the Subject Introduced of This into Summary............25 2 SECTION 3. Status of Submissions to Foreign Governments.......................................34 PART IV: DEVELOPMENT OF MON 89034 ............................................................35 SECTION 1. Corn as a Crop..........................................................................................35 1.1. Scientific name and taxonomic classification of cornISSIONS .......................................36 TO OTHER REGULATORY 1.2. Growth and Reproductive Characteristics of Corn............................................38 Monsanto Company FDA BNF No. 00105 / Monsanto 06-CR-161F Page 2 of 323 1.3. History of corn development .............................................................................38 SECTION 2. Characterization of the Vector Used in Transformation ..........................40 2.1. Method of transformation ..................................................................................40 2.2. Plasmid PV-ZMIR245 .......................................................................................41 2.2.1. T-DNA I.......................................................................................................42 2.1.1.1. The cry1A.105 gene and Cry1A.105 protein .......................................42 2.1.1.2. The cry1A.105 regulatory sequences...................................................42 2.1.1.3. The cry2Ab2 gene and Cry2Ab2 protein .............................................42 2.1.1.4. The cry2Ab2 regulatory sequences......................................................42 2.1.1.5. T-DNA borders....................................................................................43 2.2.2. T-DNA II .....................................................................................................43and and regime. 2.2.2.1. nptII gene and NPTII protein...............................................................43AG 2.2.2.2. nptII regulatory sequences...................................................................43 2.2.2.3. T-DNA borders....................................................................................43 Bayer property protectionpublishing 2.2.3. Genetic elements outside theof T-DNA borders.............................................43contents its SECTION 3. Characteriztion of the Introduced Geneticparties. Material.................................52data therefore and/oror 3.1. Insert and copy number......................................................................................60 affiliates. property intellectualthird may 3.2. Intactness of the cry1A.105its and cry2Ab2 expression cassettes ..........................62 as 3.2.1. e35S promoter/theCab of leader...........................................................................63and is regulatory owner. a document 3.2.2. Ract1 intron.................................................................................................63any such its reproductiondocument 3.2.3. cry1A.105 coding sequenceowner ........................................................................66this of under of 3.2.4. Hsp17 3' endrights sequence...............................................................................66the this documentand/or rights 3.2.5. FMV promoter.............................................................................................69to of fall use of the 3.2.6.This Hsp70 intron.................................................................................................69may distribution,and rights owner 3.2.7. SSU-CTPsubject targeting sequence/cry2Ab2 coding sequence............................70 3.2.8.be nos 3' end sequence....................................................................................74the violate copy of 3.2.9. Analysis to confirm the absenceand of plasmid PV-ZMIR245 backbone .......76 may documentpublication, 3.3.It Analysis to confirmexploitation the absence of T-DNA II...................................................78 3.3.1. Analysisthis any to confirm the absence of the nptII coding sequence...................78 permission 3.3.2. Analysis to confirmprohibited the absence of the overall T-DNA II region...............78 3.4. Insert stabilitythe across generations of MON 89034 ............................................82 commercial be 3.4.1. Summary.....................................................................................................82 Furthermore,3.4.2.any Stability of the T-DNA I insert across generations of MON 89034...........84 Consequently,without 3.4.3. Confirmation of the absence of T-DNA II in multiple generations of MON 89034.................................................................................................86 3.4.4. Confirmation of the absence of plasmid PV-ZMIR245 backbone sequence in multiple generations of MON 89034.......................................86 3.5. Organization and sequence of the insert DNA in MON 89034 .........................90 3.6. Inheritance of the lepidopteran protection trait in MON 89034 ........................90 3.7. Conclusion .........................................................................................................92 Monsanto Company FDA BNF No. 00105 / Monsanto 06-CR-161F Page 3 of 323 and and regime. AG Bayer property protectionpublishing of contents its parties.data therefore and/oror affiliates. property intellectualthird may its as the of and is regulatory owner. SECTION 4. Other data and informa a document any such its References .................................................................................................................93 reproductiondocument owner this of PART V: PRESENCE OF GENES under
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