Petition for Determination of Nonregulated Status for Corn Rootworm Protected and Glyphosate Tolerant MON 87411 Maize The undersigned submits this petition under 7 CFR § 340.6 to request that the Administrator make a determination that the article should not be regulated under 7 CFR part 340 October 4, 2013 (Revised December 18, 2013) OECD Unique Identifier: MON-87411-9 Monsanto Petition Number: CR240-13U1 USDA-APHIS Petition Number 13-290-01p Submitted by: John M. Cordts, M.S., M.B.A Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63167 Phone: (314) 694-4831 Fax: (314) 694-3080 E-mail: [email protected] Prepared by: A. Ahmad, Ph.D., P.M. Bachman, Ph.D., B.A. Comstock, B.S., J.M. Cordts, M.S., M.B.A., S. Dubelman, Ph.D., T.H. Klusmeyer, Ph.D., D.K. Kovalic, Ph.D., C.A. Lawrence, Ph.D., J.S. Petrick, Ph.D., Q. Tian, M.D., Ph.D. Contributors and/or Principal Investigators: K. Adu-tutu, Ph.D., S. Arackal, M.S., D. Anstrom, M.S., A. Beyene, Ph.D., J. Bynum, Ph.D., S.M. Carleton, Ph.D., D.B. Carson, Ph.D., M. Chen, Ph.D., K. Crowley, Ph.D., S. Drury, B.A., J. Fischer, Ph.D., R. Hileman, Ph.D., K. Howard, Ph.D., T. Lee, Ph.D., S.L. Levine, Ph.D., G. Mueller, M.A., M. Paradise, M.A., E. Parks, Ph.D., B. Sammons, Ph.D. A. Silvanovich, Ph.D., Z. Song, M.S., J. Tan, Ph.D., J. Uffman, B.S., W. Urqhart, Ph.D., J.M. Ward, Ph.D., B.J. Warner, M.S., J. Warren, B.S., F. Zapata, M.S. Monsanto Company CR240-13U1 1 of 374 RELEASE OF INFORMATION Monsanto is submitting the information in this petition for review by the USDA as part of the regulatory process. Monsanto understands that the USDA complies with the provisions of the Freedom of Information Act (FOIA). In the event the USDA receives a FOIA request, pursuant to 5 U.S.C., § 552, and 7 CFR Part 1, covering all or some of the information in this petition, Monsanto expects that, in advance of the release of the document(s), USDA will provide Monsanto with a copy of the material proposed to be released and the opportunity to object to the release of any information based on appropriate legal grounds, e.g., responsiveness, confidentiality, and/or competitive concerns. Monsanto understands that this information may be made available to the public in a reading room and upon individual request as part of a public comment period. Monsanto also understands that when deemed complete, a copy of the petition may be posted to the USDA-APHIS BRS website or other U.S. government websites (e.g., www.regulations.gov). Except in accordance with the foregoing, Monsanto does not authorize the release, publication or other distribution of this information without Monsanto's prior notice and consent. © 2013 Monsanto Company. All Rights Reserved. This document is protected under national and international copyright law and treaties. This document and any accompanying material are for use only by the regulatory authority to which it has been submitted by Monsanto Company and its affiliates, collectively “Monsanto Company,” and only in support of actions requested by Monsanto Company. Any other use, copying, or transmission, including internet posting, of this document and the materials described in or accompanying this document, without prior consent of Monsanto Company, is strictly prohibited; except that Monsanto Company hereby grants such consent to the regulatory authority where required under applicable law or regulation. The intellectual property, information and materials described in or accompanying this document are owned by Monsanto Company, which has filed for or been granted patents on those materials. By submitting this document and any accompanying materials, Monsanto Company does not grant any party or entity any right or license to the information, material or intellectual property described or contained in this submission. Monsanto Company CR240-13U1 2 of 374 CERTIFICATION The undersigned certifies that, to the best knowledge and behef of the undersigned, this petition includes all information and views on which to base a determination, and that it includes all relevant data and information known to the petitioner that are unfavorable to the petition. John M. Cordts, M.S., M.B.A. Regulatory Affairs Manager Monsanto Company 800 North Lindbergh Blvd., Mail Stop C3SD St. Louis, MO 63167 Tel: (314)-694-4831 Fax: (314)-694-3080 Monsanto Company CR240-13U1 3 of374 EXECUTIVE SUMMARY The Animal and Plant Health Inspection Service (APHIS) of the United States (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 U.S. 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 nonregulated status for the new biotechnology-derived maize product, MON 87411, any progeny derived from crosses between MON 87411 and conventional maize, and any progeny derived from crosses of MON 87411 with biotechnology-derived maize that have previously been granted nonregulated status under 7 CFR part 340. Product Description Monsanto Company has developed biotechnology-derived maize, MON 87411, that confers protection against corn rootworm (CRW) (Diabrotica spp.) and tolerance to the herbicide glyphosate. MON 87411 contains a suppression cassette that expresses an inverted repeat sequence designed to match the sequence of western corn rootworm (WCR; Diabrotica virgifera virgifera). The expression of the suppression cassette results in the formation of a double-stranded RNA (dsRNA) transcript containing a 240 bp fragment of the WCR Snf7 gene (DvSnf7). Upon consumption, the plant-produced dsRNA in MON 87411 is recognized by the CRW’s RNA interference (RNAi) machinery resulting in down-regulation of the targeted DvSnf7 gene leading to CRW mortality. MON 87411 also contains a cry3Bb1 gene that produces a modified Bacillus thuringiensis (subsp. kumamotoensis) Cry3Bb1 protein to protect against CRW larval feeding. In addition, MON 87411 contains the cp4 epsps gene from Agrobacterium sp. strain CP4 that encodes for the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein, which confers tolerance to glyphosate, the active ingredient in Roundup® agricultural herbicides. MON 87411 builds upon the current Bt protein-based mode-of-action (MOA) for CRW control by the addition of a new RNA-mediated MOA that offers enhanced control of target insect pests and prolonged durability of existing Bt technologies designed to control CRW. MON 87411 will provide benefits to growers similar to those obtained by use of existing CRW-protected maize hybrids, which include reduced need for insecticides and associated improvements in worker safety, increased yield protection, and water conservation. MON 87411 is also glyphosate tolerant and will continue to ® Roundup and Roundup Ready are registered trademarks of Monsanto Technology LLC Monsanto Company CR240-13U1 4 of 374 provide benefits associated with conservation tillage methods, including reduced soil erosion, reduced fuel and labor costs, improved air quality and conservation of soil moisture. MON 87411 will not be offered for commercial use as a stand-alone product, but will be combined, through traditional breeding methods, with other deregulated biotechnology- derived traits to provide protection against both above-ground and below-ground maize pests as well as tolerance to multiple herbicides. These next generation combined-trait maize products will offer broader grower choice, improved production efficiency, increased pest control durability, and enhanced grower profit potentials. Data and Information Presented Confirms the Lack of Plant Pest Potential and the Food and Feed Safety of MON 87411 Compared to Conventional Maize The data and information presented in this petition demonstrate that MON 87411 is agronomically, phenotypically, and compositionally comparable to commercially cultivated maize. Moreover, the data and information presented herein demonstrate that MON 87411 is not expected to pose an increased plant pest risk, including weediness, compared to commercially cultivated maize. The food, feed, and environmental safety of MON 87411 was confirmed based on multiple, well-established lines of evidence: • The CP4 EPSPS protein in MON 87411 is identical to the CP4 EPSPS protein present in several other commercially available crops that have been reviewed by USDA and previously deregulated (e.g., Roundup Ready varieties of soybean, maize, cotton, sugarbeet, canola, and alfalfa). The safety and mode-of-action of CP4 EPSPS proteins is well documented and is the subject of numerous publications. Similarly, the safety of the Cry3Bb1 protein has been previously assessed in two other corn rootworm- protected products (MON 863 and MON 88017) that have been grown on tens of millions of acres in the U.S. since their introduction. The mode-of-action of Bt proteins has also been extensively studied and is well-documented in numerous publications. • The RNA-based suppression of the Snf7 gene in western corn rootworm that results from expression of the DvSnf7 suppression cassette in MON 87411 is mediated by dsRNA molecules. Double-stranded RNAs are commonly used by eukaryotes, including plants, for endogenous gene suppression and as described in this petition, pose no novel risks from a feed/food and environment perspective. Nucleic acids, as the components of RNA, have a long history of safe consumption and are considered GRAS by the U.S.