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Petition for Determination of Nonregulated Status: Arctic™ Apple (Malus X Domestica) Events GD743 and GS784

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Petition for Determination of Nonregulated Status: ArcticTM Apple (Malus x domestica) Events GD743 and GS784 The undersigned submits this petition under 7 CFR Part 340.6 to request that the Administrator make a determination that the article should not be regulated under 7 CFR part 340. Submitted by: ___________________________ Neal Carter President Okanagan Specialty Fruits Inc. PO Box 1533 Summerland, BC V0H 1Z0 Canada Submitted February 21, 2012 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION Release of Information Okanagan Specialty Fruits Inc. (OSF) is submitting the information in this petition for review by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) as part of the regulatory process to consider article deregulation under 7 Code of Federal Regulations (CFR) part 340.6. By submitting this information, OSF does not authorize its release to any third party. In the event the USDA should receive a Freedom of Information Act request, pursuant to 5 U.S. Code (USC) 552, and 7 CFR Part 1, covering all or some of this information, OSF expects that, in advance of release of the document(s), USDA will provide OSF with a copy of any and all 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. OSF understands that a copy of this information may be made available to the public, as part of a public comment period. Except in accordance with the foregoing, OSF does not authorize the release, publication or other distribution of this information (including online hosting) without OSF’s prior notice and consent. Events GD743 and GS784 Page 2 of 163 Executive Summary The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) has the responsibility, under the Plant Protection Act (7 CFR USC sections 7701-7772), to prevent the introduction and/or dissemination of plant pests into the United States or interstate introduction and/or dissemination. APHIS regulations at 7 CFR 340.6 provide 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 therefore should no longer be regulated. If APHIS determines that the regulated article does not present a plant pest risk, the petition is granted, thereby allowing the deregulated article to be introduced into the marketplace without restriction. Okanagan Specialty Fruits Inc. (OSF) is submitting this request to APHIS for nonregulated status of ArcticTM Apple (Malus x domestica1) events GD743 and GS784 which are resistant to enzymatic browning. The “nonbrowning” phenotype of GD743 and GS784 was developed by inserting a polyphenol oxidase (PPO) suppression sequence derived from apple. When apples containing the inserted gene are subjected to mechanical damage, such as slicing or bruising, the apple flesh does not brown as an untransformed apple does, but rather remains its original color. This nonbrowning trait reduces the need for antibrowning agents on cut fruit, and minimizes shrinkage caused by harvest and postharvest damage. Cultivated apple (Malus x domestica) is one of the major temperate fruit-tree crops. OSF is developing ArcticTM Apple cultivars that will function as direct replacements for current cultivars in situations where the ArcticTM Apple trait would provide an advantage and add value. ArcticTM Apple events were produced using an Agrobacterium-based plant transformation system. The transformation vector, GEN-03, contains a chimeric PPO suppression transgene consisting of partial coding sequences of four members of the apple PPO gene family – consisting of PPO2, GPO3, APO5 and pSR7 – in the sense orientation under control of the cauliflower mosaic virus (CAMV35s) promoter and nopaline synthase (NOS) terminator. The transgene is designed to simultaneously reduce expression of PPO2, GPO3, APO5 and pSR7 to induce a nonbrowning phenotype in apple fruit. The transgene sequences were derived from the donor organism apple. Molecular characterization of ArcticTM Apple events showed that GD743 contains two copies of the transfer DNA (T-DNA), while GS784 arose from the insertion of multiple copies of the T-DNA, with no evidence for the inclusion of vector backbone in either case. Phenotypic data and other information presented in this petition demonstrate that it is no more likely that the regulated articles will present a plant pest risk than conventional apple for the following reasons: (i) no biologically meaningful agronomic or phenotypic differences in apple populations containing either event GD743 or GS784 were detected over multiple years and locations compared to control and conventional apple populations, indicating that 1 See Nomenclature and Biology of Cultivated Apple (OSF, 2011) for synonyms of Malus x domestica. Events GD743 and GS784 Page 3 of 163 there was no increased weediness or competitiveness in apple populations containing either of the ArcticTM Apple events; (ii) apple populations containing either of the transformed events were no more susceptible to disease or insect pests than conventional apple populations; (iii) the composition and quality of apples derived from the populations containing the ArcticTM Apple events were comparable to the composition and quality of apples from control and conventional apple cultivars; and (iv) the likeliness of apple outcrosses due to pollen gene flow is low – as it is in conventional orchards – and even if pollen gene flow does occur, the environmental impact would be very low, limited to the transgene being expressed in a portion of seeds only. The PPO suppression transgene does not confer plant pest characteristics to apple and as such, the transgenic GD743 and GS784 events containing the PPO suppression transgene do not represent a plant pest risk. The use of ArcticTM Apple cultivars can provide benefit by (i) minimizing shrinkage caused by harvest and postharvest damage, (ii) reducing or eliminating the need for antibrowning agents on cut fruit, and (iii) promoting the inclusion of apple in the fresh-cut fruit market. Data and information in this request demonstrate that events GD743 and GS784 do not represent a unique plant pest risk. Therefore, OSF requests a determination from APHIS that events GD743 and GS784, and progeny thereof, no longer be considered regulated articles under regulations in 7 CFR part 340. Events GD743 and GS784 Page 4 of 163 Nomenclature Throughout this petition, subject apples are referred to as “GD743” and “GS784”. The numbers “743” and “784” are the original designations of the selected clones. The letter codes were added here to identify the parent cultivars Golden Delicious (GD) and Granny Smith (GS). In accordance with the Organization for Economic Cooperation and Development's (OECD) “Guidance for the Designation of a Unique Identifier for Transgenic Plants” (OECD, 2002) GD743 has been assigned the unique identifier OKA-NBØØ1-8 and GS784 has been assigned the unique identifier OKA-NBØØ2-9. Events GD743 and GS784 Page 5 of 163 Certification The undersigned certifies that, to his best knowledge and belief, 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 petitioners which may be unfavorable to the petition. ___________________________________ Neal Carter President Okanagan Specialty Fruits Inc. PO Box 1533 Summerland, BC V0H 1Z0 Canada Events GD743 and GS784 Page 6 of 163 TABLE OF CONTENTS RELEASE OF INFORMATION ............................................................................................................................... 2 EXECUTIVE SUMMARY ......................................................................................................................................... 3 NOMENCLATURE .................................................................................................................................................... 5 CERTIFICATION....................................................................................................................................................... 6 LIST OF TABLES ....................................................................................................................................................... 9 LIST OF FIGURES ................................................................................................................................................... 11 KEY TO ABBREVIATION AND ACRONYMS .................................................................................................... 12 TM 1 RATIONALE FOR DEVELOPMENT OF ARCTIC APPLES ................................................................ 15 1.1 BASIS FOR REQUEST FOR DETERMINATION OF NONREGULATED STATUS UNDER 7 CFR PART 340.6 .... 15 TM 1.2 ARCTIC APPLE EVENTS GD743 AND GS784 .......................................................................................... 15 TM 1.3 BENEFITS OF ARCTIC APPLE EVENTS GD743 AND GS784 ................................................................... 16 1.4 SUBMISSIONS TO OTHER REGULATORY AGENCIES ................................................................................... 16 2 THE APPLE FAMILY...................................................................................................................................... 17 2.1 APPLE AS A CROP .......................................................................................................................................
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