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BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK

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BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK BASF Plant Science, L.P. Petition for the Determination of Nonregulated Status for EPA+DHA Canola Event LBFLFK 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. OECD Unique Identifier BPS-BFLFK-2 BASF Plant Science, L.P. 26 Davis Drive Research Triangle Park, NC 27709 No CBI Submitted by Jordan Sottosanto Prepared by C. Andre, D.I. Arias, M. Bhatti, S. Breazeale, H. Fu, J. Klucinec, A. Lassen, E.A. Lipscomb, C. Martin, C.R. Moore, A.L. Olson, D.W. Roberts, T. Senger, S. Settlage, C. Wandelt, I. Wenderoth, P. Wu, M.K. Wyrick November 16, 2017 Revised: January 15, 2018 BASF Registration Document Number: 2018/7002374 BASF Reg. Doc. No. 2018/7002374 Page 1 of 416 BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK Release of Information As part of the regulatory requirement in the United States, BASF Plant Science, L.P. is submitting the information in this petition for review by the USDA. The submission of this information by BASF Plant Science, L.P. does not constitute an authorization to release any information contained within it to any third party. In the event the USDA receives a Freedom of Information Act request, pursuant to 5 U.S.C., § 552, and 7 CFR Part 1, covering all or some of this information, BASF Plant Science, L.P. expects that USDA will provide BASF Plant Science, L.P. 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 in advance of the release of the document(s). BASF Plant Science, L.P. authorizes the posting of the petition on the USDA Biotechnology Regulatory Services website when it is also published in the Federal Register for public comment. BASF Plant Science, L.P. understands that a copy of this information may be made available to the public by individual request, as part of a public comment period. Except in accordance with the foregoing, BASF Plant Science, L.P. does not authorize the release, publication or other distribution of this information (including website posting) without prior notice and consent by BASF Plant Science, L.P. © 2018 BASF Plant Science, L.P. All Rights Reserved. This document is protected under copyright law. This document is for use only by the regulatory authority to which it has been submitted by BASF Plant Science, L.P. and only in support of actions requested by BASF Plant Science, L.P. Any other use or citation of this material, without prior written consent of BASF Plant Science, L.P., is strictly prohibited. By submitting this document, BASF Plant Science, L.P. does not grant any party or entity any right to license or to use the information or intellectual property described in this document. Beyond and Clearfield are registered trademarks of BASF Corp.; Excellence Through Stewardship is the registered trademark of Excellence Through Stewardship Corp.; GenBank is a registered trademark of the US Department of Health and Human Services; HiSeq is a trademark and Illumina is the registered trademark of Illumina, Inc.; LibertyLink is a registered trademark of the Bayer Group; Roundup Ready is the registered trademark of Monsanto Technology LLC; TaqMan is a registered trademark of Roche Molecular Systems, Inc. All trademarks recited herein are the intellectual property of their respective owners. No right to use any of these trademarks is granted by its recitation in this document. BASF Reg. Doc. No. 2018/7002374 Page 2 of 416 BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK EXECUTIVE SUMMARY BASF Plant Science, L.P. is submitting this request to USDA-APHIS for a determination of nonregulated status for the EPA+DHA canola (Brassica napus L.) event LBFLFK (OECD unique identifier BPS-BFLFK-2) and requests a determination from USDA-APHIS that LBFLFK canola and any progeny derived from LBFLFK canola by traditional breeding methods and naturally occurring crosses between LBFLFK canola and compatible species that are not regulated be considered nonregulated articles under 7 CFR part 340. As part of this petition, BASF is submitting phenotypic and genotypic experimental data, agronomic data, grain compositional data, safety assessment data, and other relevant information to fulfill the requirements of 7 CFR § 340.6 for an assessment of EPA+DHA canola event LBFLFK. Product Description and Intended Uses LBFLFK canola was produced using biotechnology to introduce newly expressed proteins. More specifically, recombinant DNA containing genes encoding fatty acid desaturase and elongase proteins and an herbicide resistant acetohydroxy acid synthase protein was introduced into the conventional canola variety Kumily by Agrobacterium rhizogenes-mediated transformation using a single transformation vector. The expression of these proteins in LBFLFK canola allows for the synthesis of long-chain omega-3 polyunsaturated fatty acids (LC-PUFAs), including EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), from oleic acid and for tolerance to treatment with an imidazolinone herbicide. LBFLFK canola provides a plant-based and scalable production system for omega-3 fatty acids and will be another source of EPA and DHA for consumers as either a food ingredient or as an aquaculture feed ingredient. Currently, the omega-3 LC-PUFAs EPA and DHA are primarily consumed through seafood, including finfish (e.g., salmon, tuna, and trout) and shellfish (e.g., crab, mussels, and oysters). Numerous health organizations recommend adult intakes of 250 to 500 mg combined EPA and DHA per day. While this recommendation is met in some countries, many countries, including the United States, fall below the recommended average daily intake. The primary reason for this deficiency is that the supply of these fatty acids from marine animal and other sources is limited. There is a significant challenge in producing and distributing products containing EPA and DHA to consumers in adequate quantity. There is also high demand for fish oil as a primary ingredient for farmed fish, especially fatty fish like salmon or trout. This demand is not met to the point where the harvested fish now have reduced levels of omega-3 fatty acids compared to historical levels. BASF Reg. Doc. No. 2018/7002374 Page 4 of 416 BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK The herbicide tolerance trait of LBFLFK canola allows for selective post-emergence weed control during field production. Pending approval from the U.S. EPA for label use, Beyond® herbicide, containing active ingredient imazamox, an imidazolinone, will be used on LBFLFK canola as part of a weed management program. Rate, weed growth stage, adjuvants, spray volume and pressure, and nozzle use will follow all label directions. Agronomic practices will be similar to those used with Clearfield® canola, which also has imidazolinone herbicide tolerance, and provides a significant tool to growers for selective breeding and broad spectrum weed control. Clearfield® products have been widely adopted in North America, and herbicide applications for LBFLFK canola will follow established weed control practices. Event LBFLFK will be cultivated within the United States and processed either in the United States or Canada as other available specialty canola varieties. To maintain the quality and ensure the segregation of LBFLFK canola seeds, grains, and processed products, an Identity Preservation System (IDP) will be implemented at every step of production and handling. Processing operations will be conducted either at dedicated facilities or at facilities with specific measures in place to ensure segregation from other products. Like other canola varieties, the products of LBFLFK canola will be processed into oil and defatted meal fractions. Oil and meal from canola can be manufactured into a variety of products for human and animal consumption or for industrial purposes. As a specialty canola with a fatty acid profile containing the LC-PUFAs EPA and DHA, the oil produced from LBFLFK canola will be sold specifically for the purpose of providing dietary omega-3 LC-PUFAs. The oil will be incorporated as an ingredient into consumer food items to provide individuals more options for dietary omega-3 LC-PUFAs. The refined oil may also be provided to dietary supplement manufacturers as an alternate source of omega-3 LC-PUFAs. The oil will also be used as an aquafeed input ingredient to international operations to provide omega-3 LC-PUFAs to farmed aquatic species. The defatted meal produced from LBFLFK canola, containing only a very small percent of fat, will not be sold as a specialty product and will be available for use in the same applications as conventional canola meal, including livestock feed. Data and Information Presented Confirms the Lack of Plant Pest Potential and the Food and Feed Safety of LBFLFK Canola Compared to Conventional Canola The data and information presented in this petition demonstrate LBFLFK canola is agronomically, phenotypically, and compositionally comparable to conventional canola, with the exception of the introduced proteins and the associated changes in the composition of fatty acids, including omega-3 LC-PUFAs. The data presented demonstrate LBFLFK canola is unlikely to pose an increased plant pest risk, including weediness characteristics or adverse environmental impacts, compared to conventional canola. The food, feed, and environmental safety of LBFLFK canola was confirmed based on multiple, well established lines of evidence: • Canola is a familiar crop that has a history of safe consumption and serves as an appropriate basis for comparison for LBFLFK canola. BASF Reg. Doc. No. 2018/7002374 Page 5 of 416 BASF Plant Science, L.P. EPA+DHA Canola Event LBFLFK • A detailed molecular characterization of the introduced DNA in LBFLFK canola demonstrated two intact, stable copies of the intended T-DNA insert at two loci within the canola genome.
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