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 The undersigned submitsPetition this petition for the to Determination reque may documentpublication, It exploitation this any Roundup RReady2Yield permission prohibited the commercial be status of the article under 7 CFR Part 340 Furthermore,any Consequently,without ™ Soybeanof Nonregulated MON 89788 Status for OECD Unique IdentifierSubmitted MON-89788-1 June 27, 2006 Revised November 3, 2006 st a determination of the nonregulated Monsanto Petition # 06-SB-167U Submitted by: 800 NorthMonsanto Lindbergh Company Blvd. St. Louis, MO 63167 Prepared by: Monsanto Company 06-SB-167U Page 1 of 237 Contributors: 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 Monsanto is submitting the information in this reproductiondocument owner this of the regulatory process. By submitting this release to any third party. In the event under of this and/orrights the Act request, pursuant to 5 U.S.C., § 552, and 7 document to fall of rights information, Monsanto expects that, in adva of use will provide Monsanto with a copy of the material proposed to be released and the the opportunity to object to the release of a This may distribution,and grounds, e.g. responsiveness, c rights owner subject understands that a copy of this information reading room and by individual request, as pa Release of Information the violate be copy accordance with the foregoing, Monsanto does not of other distribution of this information (incl and prior notice and consent. may documentpublication, It exploitation this any information, Monsanto does not authorize its permission the USDApetition receives for a reviewFreedom by ofthe Information USDA as part of prohibited onfidentiality, and/or compet the be commercial nce of the release of the document(s), USDA CFR Part 1, covering all or some of this Furthermore, ny information based on appropriate legal any Consequently,without may be made available to the public in a rt of a public comment period. Except in uding website posting) without Monsanto's authorize the release, publication or itive concerns. Monsanto © 2006 Monsanto Company. All Rights Reserved. This document is protected under copyright la regulatory authority to which this has been support of actions requested by Monsanto Co without prior written consent of Monsanto, is document, Monsanto does not grant any party or entity any right or license to the information or intellectual propert Monsanto Company 06-SB-167U Page 2 of 237 submitted by Monsanto Company, and only in y described in this document.w. This document is for use only by the mpany. Any other use of this material, strictly prohibited. By submitting this 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 The undersigned certifies that, to the best knowledge and belief of the undersigned, this reproductiondocument owner this of petition includes all information and views on wh under of includes all relevant data and information known rightsthe this the petition. documentand/or rights to of fall use of the This may distribution,and rights owner subject the violate be copy of Regulatory Affairs Manager Certification and may documentpublication, It exploitation this Address: any Monsanto Company permission 800 North Lindbergh Blvd., E3NB prohibited Saint Louis, MO 63167 the ich to base a determination, and that it commercial be Tel: to the petitioner that are unfavorable to Fax: Furthermore,any Consequently,without Monsanto Company 06-SB-167U Page 3 of 237 Summary Monsanto Company is submitting this request to APHIS for a determination of nonregulated status for MON 89788 soybean and any progeny derived from crosses between MON 89788 and other soybeans, including conventional and other genetically- modified soybeans that have been granted nonregulated status under 7 CFR Part 340. Roundup Ready® soybean 40-3-2 (herein referred to as Roundup Ready soybean) was the first soybean product containing a biotechnology trait commercialized in the U.S. Roundup Ready soybean was produced by incorporation of the cp4 epsps coding sequence derived from the common soil bacterium Agrobacterium sp. strain CP4. The cp4 epsps coding sequence directs the production of the 5-enolpyruvyl shikimate-3- regime.and phosphate synthase (termed CP4 EPSPS) that is less sensitive toand inhibition by glyphosate AG compared to plant endogenous EPSPS. The CP4 EPSPS renders Roundup Ready soybean tolerant to glyphosate, which is the active ingredient in Roundup® agricultural herbicides. The utilization of Roundup Bayeragricultural property herbicides protection pluspublishing Roundup Ready soybean, collectively referred to as theof Roundup Ready soybean system,contents has provided its significant convenience in weed control, encouragedparties. the usedata of conservation-tillage,therefore and and/or provided positive economic impact to the farmers. In 2005, Roundupor Ready soybean affiliates. was planted on approximatelyproperty 87% of theintellectual U.S.third (USDA-NASS, 2005a)may and 60% of the its global soybean areas (James, 2005), whichas is the most cultivated biotechnology product the of and to date. is regulatory owner. a document any such its reproductiondocument Developments in biotechnology andowner molecular-assisted this bree ding ofhave enabled Monsanto under of to develop a second-generationrightsthe glyphosate-tolerantthis soybean product, Roundup document™ and/or rights RReady2Yield or MONto 89788.of fall MON 89788use ofwill continue to provide growers flexibility, simplicity, and cost effective weed control theoptions; in addition, MON 89788 and varietiesThis containing the traitmay have distribution, theand potential to enhance yield and thereby further rights owner benefit farmers andsubject the soybean industry. MON 89788 was developed by introduction of the violate the cp4 epspsbe gene copy cassette containing a promoter that has been used in other crops such as Roundup Ready Flex cotton (Fincherof et al., 2003). In addition, the transformation was and based onmay a new documenttechniquepublication, of Agrobacterium -mediated gene delivery to soybean It exploitation meristem, wherethis cells were induced directly to form shoots and give rise to transgenic plants (Martinell et anyal., 2002). This new technique allowed direct transformation of the permission gene cassette into elite soybeanprohibited germplasm such as the Asgrow soybean variety A3244 (Paschal, 1997), whichthe is knowbe n for its superior agronomic characteristics and high yielding propertycommercial (Tylka and Marett, 1999). Using elite germplasm as the base genetics, theFurthermore, superiorany agronomic characteristic of A3244 can be introgressed to other soybean varietiesConsequently, throughwithout crosses with MON 89788 containing the cp4 epsps cassette. In general, MON 89788 has been found to have a 4 to 7% yield advantage compared to Roundup Ready soybeans in the same elite genetic background (A3244) while maintaining the weed control and crop safety benefits of the Roundup Ready soybean system. As a result, MON 89788 will be an excellent agronomic base trait for future breeding improvements and multi-trait products. ® Roundup and Roundup Ready are registered trademarks of Monsanto Technology LLC ™ Roundup RReady2Yield is a trademark of Monsanto Technology LLC Monsanto Company 06-SB-167U Page 4 of 237 The data and information presented in this summary demonstrate that MON 89788 is not likely to pose an increased plant pest potential or to have an increased environmental impact compared to conventional soybean. This conclusion is based on several lines of evidence. The first is the detailed molecular characterization of the inserted DNA. Results confirm the insertion of an intact cp4 epsps cassette integrated at a single locus within the genome. The second is a detailed biochemical characterization of the CP4 EPSPS protein produced in MON 89788. Data demonstrate that the CP4 EPSPS produced in MON 89788 is equivalent to the CP4 EPSPS proteins consumed in foods and feeds derived from other Roundup Ready crops such as Roundup Ready soybean that have an experience of safe use. The third is an updated assessment of the toxicity and allergenicity potential of the CP4 EPSPS protein produced in MON 89788 based on regime.and extensive information collected and studies performed on theand protein. Results confirm AG the previous assessment and the safety of the CP4 EPSPS due to the lack of allergenic potential and the lack of acute toxicity when ingested. The fourth is the compositional and nutritional assessment of MON 89788Bayer grain andproperty forage, whichprotection confirmspublishing that MON 89788 is compositionally equivalent to andof as safe as conventional soybeans.contents Finally, the its extensive evaluation of the MON 89788 phenotypicparties. characteristicsdata andtherefore ecological interactions demonstrates that MON 89788 is not likely