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Petition No. 13-022-01P

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Petition No. 13-022-01P Petition for Determination of Nonregulated Status for InnateTM Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise: Events E12 and E24 (Russet Burbank); F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); G11 (G); H37and H50 (H) We submit this petition under 7 CFR 340.6 to request that the Administrator make a determination that the articles should not be regulated under 7 CFR Part 340. Submitted by Pete Clark Ph.D. J.R. Simplot Company Prepared by Pete Clark Ph.D.* and Susan Collinge Ph.D. J.R. Simplot Company Submitted on March 1, 2013 J.R. Simplot Company Petition JRS01 OECD Unique identifiers: SPS-F10-7 SPS-F37-7 SPS-E12-8 SPS-E24-2 SPS-J3-4 SPS-J55-2 SPS-J78-7 SPS-G11-9 SPS-H37-9 SPS-H50-4 J. R. Simplot Company Contributors: Jingsong Ye Ph.D., Troy Weeks Ph.D., Hua Yan Ph.D., Craig Richael Ph.D., Roshani Shakya Ph.D., Rekha Chawla Ph.D., Hui Duan Ph.D., Pete Clark Ph.D., and Susan Collinge Ph.D. *Corresponding Author: Pete Clark Ph.D. J.R. Simplot Company 5369 West Irving Street Boise, ID 83706 Tel.: (208) 780-6066 This Document (Including Appendices) Does Not Contain CBI J.R. Simplot Company JRS01 Page 1 of 74 Petition for Determination of Nonregulated Status The undersigned submit this petition under 7 CFR 340.6 to request that the Administrato"'make a determination that the articles should not be regulated under 7 CFR part 340. ~~ Pete Clark, Ph.D. Manager Regulatory Affairs J.R. Simplot Company 5369Boi:;z:__ West Irving Street ' ~.~R Director Regulatory Affairs J.R. Simplot Company 5369 West Irving Street Boise, ID 83706 J.R. Simplot Company JRSOl Page 2 of 74 Release of Information J.R. Simplot Company is submitting the information in this assessment for review by the USDA as part of the regulatory process. By submitting this information, J.R. Simplot Company does not authorize its release to any third party except to the extent it is requested and required under the Freedom of Information Act, 5 U.S.C., paragraph 552; USDA complies with the provisions of FOIA and USDA’s implementation regulations (7 CFR Part 1.4). Except in accordance with the Freedom of Information act, J.R. Simplot Company does not authorize the release, publication or other distribution of this information without J.R. Simplot Company’s prior notice and consent. J.R. Simplot Company JRS01 Page 3 of 74 Table of Contents Abbreviations, Acronyms, and Definitions ................................................................................................... 7 Summary ....................................................................................................................................................... 9 1. Rationale for Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise ................... 12 1.1. Basis for Determination of Nonregulated Status ....................................................................... 12 1.2. Rationale for Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise ........... 13 1.3. Benefits of Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise .............. 14 1.4. Submissions to Other Regulatory Agencies ................................................................................ 15 1.5. Conclusions: Rationale for Development of Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise ...................................................................................................................... 15 2. The Biology of Potato .......................................................................................................................... 15 2.1. History of Potato ......................................................................................................................... 15 2.2. Use of the Potato as Food and Feed in the USA ......................................................................... 16 2.3. Taxonomy of the Genus Solanum ............................................................................................... 16 2.4. Genetics of Potato ...................................................................................................................... 17 2.5. Potato Growth and Life Cycle ..................................................................................................... 17 2.6. Seed Propagation ........................................................................................................................ 18 2.7 Variety Development .................................................................................................................. 18 2.8. Recipient Potato Varieties .......................................................................................................... 20 2.9. Typical Agronomic Practices ....................................................................................................... 20 2.10. Pollination and Outcrossing ........................................................................................................ 20 2.11. Wild potatoes in the U.S. ............................................................................................................ 21 2.12. Weediness .................................................................................................................................. 23 2.13. Conclusions: The Biology of Potato ........................................................................................... 23 3. Method of Development: Description of Marker-Free DNA Transformation .................................... 24 3.1. Introduction ................................................................................................................................ 24 3.2. Parental Varieties ....................................................................................................................... 25 3.3. Plasmid used for Transformation ............................................................................................... 26 3.4. Backbone Portion of pSIM1278 .................................................................................................. 28 3.5. The Transfer DNA (DNA insert) of the Vector ............................................................................ 28 3.6. Open Reading Frames Associated with the DNA Insert ............................................................. 30 3.7. Conclusions of Methods of Development: Description of Marker-Free DNA Transformation .. 30 4. Characteristics of Transferred DNA and Gene Regulation ................................................................. 31 4.1. Description and History of the Modification .............................................................................. 31 4.2. Verification of Insert Integrity and Number of Inserted Sequences .......................................... 32 4.3. Selection of Backbone-free Plants .............................................................................................. 37 4.4. Flanking Regions of Inserted Sequences .................................................................................... 37 4.5. Stability of Inserted DNA ............................................................................................................ 38 4.6. Event-Specific PCR ...................................................................................................................... 38 4.7. Conclusions: Characteristics of transferred DNA and Gene Regulation ..................................... 38 5. Expression of the Gene Products ........................................................................................................ 39 6. Efficacy and Tissue-Specificity of Gene Silencing................................................................................ 40 7. Agronomic Performance, Disease, and Efficacy of Traits ................................................................... 41 7.1. Agronomy and Phenotypic Evaluation ....................................................................................... 42 7.2. Disease susceptibility and polyphenol oxidase .......................................................................... 44 7.3. Disease Incidence: Storage Studies ............................................................................................ 46 7.4. Disease Incidence: Late Blight and Bacterial Soft Rot ................................................................ 46 J.R. Simplot Company JRS01 Page 4 of 74 7.5. Evidence of Trait Efficacy: Reducing Sugars ............................................................................... 46 7.6. Evidence of Trait Efficacy: Black Spot Bruise ............................................................................. 47 7.7. Evidence of Trait Efficacy: Reduced Asparagine and Acrylamide .............................................. 47 7.8. Survival in Fields ......................................................................................................................... 49 7.9. Conclusion on Agronomic Performance, Disease, and Efficacy of Traits ................................... 49 8. Compositional assessment ................................................................................................................. 50 8.1. Proximates, Vitamins, Minerals, and Glycoalkaloids .................................................................. 50 8.2. Allergenicity of Innate™ Potatoes .............................................................................................. 55 8.3. Conclusions of Compositional Assessment
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