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 be the violate copy of and may documentpublication, It exploitation this any permission prohibited the commercial be Furthermore,any Consequently,without 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 be the violate copy of and may documentpublication, It exploitation this any permission prohibited the commercial be Furthermore,any Consequently,without 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 be the violate copy of and may documentpublication, It exploitation this any permission prohibited the commercial be Furthermore,any Consequently,without 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 documentits any such reproduction this documentof Monsanto is submitting the information in this owner the regulatory process. By submitting this in under of rightsthe this release to any third party. In the event documentand/or of rights request, pursuant to 5 U.S.C., § 552 and 7 CFR to of fall use information, Monsanto expects that, in adva the will provide Monsanto with a copy of the material proposed to be released and the This may distribution,and opportunity to object to the release of a rights owner grounds, e.g., responsiveness, confidentiality, and/or competitive concerns. Monsanto subject expects that no information that has been identified as CBI (confidential business the violate be information), will be provided to any third party. Monsanto Releaseunderstands of Information that a CBI- copy of deleted copy of this information may be made document and and by individual request, as part of a public comment period. Except in accordance with may publication,exploitation the foregoing, Monsanto does not It of this information (including website pos this any consent. the USDA receives a Freedom of Information Act permission petition for review by the USDA as part of prohibited formation, Monsanto does not authorize its the be commercial nce of the release of the document(s), USDA CBI Deleted Version Furthermore,any ny information Partbased 1, oncovering appropriate all or legalsome of this Consequently,without authorize the release, public available to the public in a reading room ting) without Monsanto's prior notice and ation or other distribution © 2006 Monsanto Company. All Rights Reserved. This document is protected under copyright law. This document is for use only by the regulatory authority to which this has been submitted by Monsanto Comp Monsanto Company. Any other use of this material, without prior written consent of Monsanto, is strictly prohibited. By submitting this document, Monsanto does not grant any party or entity any right or license to the information or intellectual property described in this document. Monsanto Company 06-CR-166U Page 2 of 262 any, and only in support of actions requested by 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 be the violate copy of and may documentpublication, It exploitation this any permission prohibited the commercial be Furthermore,any Consequently,without CBI Deleted Version Petition for the Determination of Non-regulated Status for MON 89034 Summary The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has responsibility under the Plant Protection Act (Title IV Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. § 7701-7772) and the Plant Quarantine Act (7 U.S.C. § 151-167) to prevent the introduction and dissemination of plant pests into the United States. The APHIS regulation 7 CFR Part 340.6 provides that an applicant may petition APHIS to evaluate submitted data to determine that a particular regulated article does not regime.and present a plant pest risk and should no longer be regulated. If andAPHIS determines that the AG regulated article does not present a plant pest risk, the petition is granted, thereby allowing unrestricted introduction of the article. Bayer property protectionpublishing Monsanto Company is submitting thisof request to APHIS for a determinationcontents of non- its regulated status for the new biotechnology-derivedparties. corndata product, MONtherefore 89034, any progeny derived from crosses between MON 89034 and conventionaland/oror corn, and any affiliates. progeny derived from crossesproperty of MON intellectual89034third with other biotechnology-derivedmay corn its which has been granted non-regulated statusas under 7 CFR Part 340. the of and is regulatory owner. a document Corn (Zea mays L.) is the largestany such crop grown in the U.S. in terms ofits acreage planted and reproductiondocument net value. Insect pests in the corn fields,owner if not properlythis controllofed, significantly reduce corn yields and grain quality. In 1997,under Monsanto of commercialized a biotechnology- rightsthe this derived corn documentproduct,and/or YieldGard ® Corn Borer corn (i.e., MONrights 810) which contains the to of fall use of Bacillus thuringiensis (Bt) cry1Ab gene. The expressionthe of Cry1Ab protein in corn plants providesThis effective protectionmay distribution,againstand damage caused by lepidopteran insect pests, rights owner such as Europeansubject corn borer. Since the launch of MON 810, several other Bt corn products have also been commercializedthe in theviolate U.S., including YieldGard® Rootworm be copy corn which expresses Cry3Bb1 proteinof that confers protection against coleopteran pests. and In 2005,may approximately document publication,35% of the total U.S. corn acreage was planted with corn seed It exploitation possessing insectthis resistance trait. any permission Monsanto has recently developedprohibited MON 89034 as a second generation insect protection corn product to provide enhanced benefits for the control of lepidopteran insect pests. the be MON 89034 producescommercial the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensisFurthermore,any, which are active against lepidopteran insect pests. Compared to MON 810, MONConsequently, 89034 willwithout better serve corn growers’ need for controlling a wider spectrum of lepidopteran pests and help assure the durability of Bt corn. MON 89034 provides outstanding control of Ostrinia species such as European corn borer (ECB) and Asian corn borer, and Diatraea species such as southwestern corn borer (SWCB) and sugarcane borer. Control of these insects provided by MON 89034 is comparable to MON 810. MON 89034 also provides a high level control of fall armyworm (FAW) throughout the season, whereas MON 810 principally controls fall armyworm larvae during vegetative growth stage. Furthermore, MON 89034 provides significantly improved protection from Monsanto Company 06-CR-166U Page 4 of 262 CBI Deleted Version damage caused by corn earworm (CEW) than MON 810. In addition to the wider spectrum of insect control, the combination of the Cry1A.105 and Cry2Ab2 insecticidal proteins in a single plant, MON 89034, provides a much more effective insect resistance management (IRM) tool. The results of mathematical modeling indicate that biotechnology-derived plants expressing two Cry proteins will have significantly greater durability than plants producing either of the single proteins if the cross-resistance between the Cry proteins is low and the mortality of susceptible insects caused by each of the individual proteins is at least 90%. Comparative biophysical studies indicate that the Cry1A.105 and Cry2Ab2 proteins have important differences in their mode of action, specifically in the way in which they bind to the lepidopteran midgut. Therefore, the probability of cross-resistance between these two proteins is low. Furthermore, in vitro and in planta studies with Cry1A.105 and Cry2Ab2 demonstrate that both proteins are regime.and highly active against the primary lepidopteran pests of corn and(ECB, SWCB, CEW, and AG FAW), particularly ECB, achieving close to or greater than the critical 95% level of control in all cases. With these properties, MON 89034 should be durable with a significantly smaller structured refuge thanBayer is necessary property for Bt cornprotection productspublishing producing a single insecticidal protein. of contents its parties.data therefore The data and information presented in this application demonstrateand/oror