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/or or affiliates. property intellectualthird may its as the of and is regulatory owner. a document any such its reproductiondocument owner this of Monsanto is submitting the information in this the regulatory process. By submitting this under of this release to any third party. In the event and/orrights the document fall of rights request, pursuant to 5 U.S.C., § 552, and 7 CFR to of 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 owner rights grounds, e.g., responsiveness, c RELEASE OF INFORMATION subject understands that a copy of this information be the violate reading room and by individual request as pa copy of accordance with the foregoing, Monsanto does not and other distribution of this information (incl may documentpublication, It exploitation prior notice and consent. this any permission the USDA receives a Freedom of Information Act prohibited information,petition Monsanto for review does by the not USDA authorize as part its of the commercial be onfidentiality, and/or compet nce of the release of the document(s), USDA Furthermore,any Consequently,without ny information Partbased 1, oncovering appropriate all or legalsome of this may be made available to the public in a ©2010 Monsanto Company. All Rights Reserved. rt of a public comment period. Except in This document is protected under copyright la uding website posting) without Monsanto's regulatory authority to which it has been submitted by Monsanto Company and only in authorize the release, publication or support of actions requested by Monsanto Co itive concerns. Monsanto without prior written consent of Monsanto, is document, Monsanto does not grant any party or information or intellectual propert y described in this document.w. This document is for use only by the Monsanto Company mpany. Any other use of this material, strictly prohibited. By submitting this entity any right to license or to use the 10-CR-214U 2 of 398 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 EXECUTIVE 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) to prevent the introduction and dissemination of plant pests into the United States. APHIS regulation 7 CFR § 340.6 provides that an applicant may petition APHIS to evaluate submitted data to determine that a particular regulated article does not present a plant pest risk and no longer should be regulated. If APHIS determines that the regulated article does not present a plant pest risk, the petition is granted, thereby allowing unrestricted introduction of the article. Monsanto Company is submitting this request to APHIS for a determination of regime.and nonregulated status in whole for the new biotechnology-derivedand maize product, AG MON 87427, any progeny derived from crosses between MON 87427 and conventional maize, and any progeny derived from crosses of MON 87427 with other biotechnology- derived maize that has been granted nonregulatedBayer statusproperty under 7 protectionCFR Partpublishing 340. of contents its parties.data therefore Product Description and/oror affiliates. property intellectualthird may Monsanto Company has developedits biotechnology-derived MON 87427 maize with as tissue-selective glyphosatethe tolera ofnce to facilitateand the production of viable hybrid maize is regulatory owner. seed. MON 87427 produces the same 5-enolpyruvylshikimate-3a document -phosphate synthase any such its reproductiondocument ® (CP4 EPSPS) protein that is producedowner in commercial thisRoundup Readyof crop products, via the incorporation of a cp4 epsps coding sequence. CP4 EPSPS confers tolerance to the under of this herbicide glyphosate.and/or Tissue-selectiverights the expression of CP4 EPSPS protein in MON 87427 document fall of rights enables an extension ofto the useof of glyphosateuse tolerant maize as a tool in hybrid maize the seed production.This may distribution,and rights owner subject MON 87427 utilizes a specific promoter and intron combination (e35S-hsp70) to drive be the violate CP4 EPSPS proteincopy expression in vegetativeof and female reproductive tissues, conferring tolerance to glyphosate in the leaves, stalk,and and root tissues and tissues that develop into may documentpublication, seed orIt grain and silks. Thisexploitation specific promoter and intron combination also results in limited or no productionthis any of CP4 EPSPS protein in two key male reproductive tissues: pollen microspores which permissiondevelop into pollen grains, and tapetum cells that supply nutrients to the pollen. Thus, inprohibited MON 87427, male reproductive tissues critical for male the gametophyte developmentcommercial are be not tolerant to glyphosate. This allows glyphosate-treated MON 87427 containing inbred lines to serve as a female parent in the production of hybridFurthermore, seed.any Two glyphosate applications beginning just prior and/or during tassel developmentConsequently, stageswithout (approximate maize vegetative growth stages ranging from V8 to V13) will produce a male sterile phenotype through tissue-selective glyphosate tolerance, and will eliminate or greatly reduce the need for detasseling which is currently used in the production of hybrid maize seed. In a hybrid maize seed production system, the MON 87427 inbred plants, with glyphosate applied at tassel development timings will be pollinated by pollen donor (male) plants, resulting in viable hybrid maize seed carrying ® Roundup and Roundup Ready are registered trademarks of Monsanto Technology, LLC Monsanto Company 10-CR-214U 4 of 398 the gene for tissue-selective glyphosate tolerance. For weed control during seed production and in commercial fields, glyphosate may be applied to MON 87427 at vegetative stages as directed on Roundup® agricultural product labels, at the same rates used in previously deregulated Roundup Ready® corn 2 events (NK603 and MON 88017). Only specifically timed glyphosate applications beginning just prior and/or during tassel development stages (approximate maize vegetative growth stages ranging from V8 to V13) will produce a male sterile phenotype through tissue-selective glyphosate tolerance in MON 87427. Glyphosate is a systemic herbicide that is readily translocated via the phloem in plants. Once glyphosate is in the phloem, it moves to areas of high meristematic activity, following a typical source to sink distribution. Pollenregime. developmentand in a maize plant takes approximately 4 weeks to complete. andEarly tassel growth stages AG start at the approximate maize vegetative growth stage V9, therefore glyphosate applications made at approximately this time allow maximum translocation of glyphosate to the male reproductive tissues, and selectivelyBayer causeproperty cell death protection in onlypublishing those cells that are not tolerant to glyphosate (i.e. tapetumof and pollen cells). Glyphosatecontents applications its made during early vegetative stages, consistent withparties. the applicationdata timingtherefore specified in the current Roundup agricultural product label for weed controand/orl purposes,or do not affect affiliates. pollen production of MON 87427property because intellectual the sensthirditive male reproductivemay tissues are not its actively developing at that time. as the of and is regulatory owner. a document The benefits of MON 87427any in thesuch production of hybrid seed include:its reproductiondocument Increased Flexibility in Hybridowner Seed Productionthis: Each yearof approximately 0.5 M under of acres used for hybridrights maizethe seed production mustthis be detasseled in order to meet documentand/or rights commercial growers’to ofhybrid fall maize seeduse needs of and to meet established seed purity criteria in the U.S. The critical time period forthe detasseling is after the tassel has emergedThis but prior to pollenmay sheddistribution, andand silk emergence, and encompasses an average rights owner 3 - 4 daysubject window. Current detasseling practices may require up to two passes with mechanical detasseling equipmentthe violateand up to three passes if hand detasseling be copy is used. Further complicatingof detasseling activity is the logistical planning and requiredmay fordocument movingpublication, enough