23/01/2018. The Importance of Plant Breeding Innovation - Some Background ESA MEMBERS TODAY

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1 ESA MEMBERS TODAY The Importance of Plant Breeding Innovation for the EU Seed Sector - political, regulatory and communicational needs San Diego, national seed associations (ESA Association Members) 40 direct company members (ESA Individual Members) 29 associate company members (ESA Associate Members) ESA represents more than 7000 seed businesses in the EU and beyond 2 EU SEED MARKET KEY FACTS AND FIGURES New varieties are authorized for marketing within the European Union each year. Size of largest company in each sector of the agrifood chain and chemicals globally Different varieties of agricultural and vegetable species are available to farmers in the European Union. US $~ 50 bn Global Seed Market EU seed market share around 20% Source: Sylvie Bonny, Sustainability 2017, 9, Why Plant Breeding Innovation is important The Importance of Plant Breeding Innovation - Some Background 5 6 1

2 Plant Breeding Innovation is an Evolution of improved Breeding Methods The Plant Breeding Innovation Cycle BDP 7 8 THE LATEST PLANT BREEDING METHODS: IMPORTANCE TO PRIVATE BREEDERS Methodologies can be used across all agriculturally and horticulturally important crops Efficient and precise Reduces R&D and breeding time Important for plants with long generation times & comple genomes Important for crops with rapidly evolving diseases and pests Accessible & relatively inepensive Important to companies of all sizes Genome Editing 1/2 is faster and more efficient: the result is identical Crossing and Selection High-performance variety Wilde type with desired trait Genome Editing SDN1/2 High-performance variety 7 generations / about 1000 plants Improved highperformance 2 generations / about plants variety 9 10 Scientific /Technical prerequisites for developing traits by means of Genome Editing relevant target genes are identified their biological function is understood the eact gene sequence is known the optimal mutation point is identified the relevant enabling technologies are developed and applicable (tissue culture, transformation etc.) Etensive research on gene identification and improvement of enabling technologies is needed: not only in companies, but also in the public research environment. Eisting Breeding Goals can be achieved in a more efficient way Quality Traits Yield Resistances Baking quality (e.g N-glycans Corn yield (pod shatter resistant oil Viruses (Cucumis: Zucchini Yellow modification in barley, gluten free seed rape, grain weight and enhanced Mosaic virus; Papaya ring spot Virus) wheat) grain number in rice and oilseed rape, parthenocarpic tomato plants) Brewing quality (e.g. low lo barley) Biomass yield Bacteria Fatty acid composition (e.g. soybean/ Starch, Protein, Sugar content Insect Camellina) Increased Vitamin content Nutrient use Efficiency Fungi (e.g. Powdery Mildew in Wheat and tomato, late blight potato, blast resistant rice) Improved shelf life (improved cold Water use Efficiency Drought, Heat, Salt (salt stress storage potato, non-browning tolerant rice, drought stress mushroom/apple/potato) resistant corn) Starch quality (e.g. way corn, Herbicides (e.g. oilseed rape, linum, amylopectin potato, high-amylose rice) rice, potato) Feed quality (low-phytate maize)

3 Central Questions Political/ Regulatory Debate in the EU: Central Questions Political/ Regulatory Debate in the EU 1) Can the productsresulting fromthe latestplant breeding methodsbe regulated under the current EU-GM-legislation (directive 2001/18) or is there a need to amend the directive? 2) If the current legislation can be applied: Which of the products fall under the regulation (lead to a gmplant)? Political framework - Lots of Activity since 2007 but still no Guidance by EU-Commission Competent Authorities Member State Eperts Working Group Scientific evaluation with regard to directive 2001/18 EU-Commission JRC IPTS/IHCP JRC-Report (scientific and economic evaluation) Detection (modifications on molecular level) International Regulation EFSA Safety Aspects Cisgenesis ZFN3 other NBTs French ECJ Courtcase SAM (Scientific Advice Mechanism) Focus Genome Editing; Key characteristics of methods Comparison with earlier methods II 16 classical mutagenesis I III Random Mutation Genome Editing and Regulatory Questions where to draw the Line? Mutation (SDN-1) I,II or III unspecific nucleotide echanges (I), additions (II) or deletions (III) Edit (SDN-2) applications of genome editing I or II Replacement (SDN-3) small edits (specific base pair echanges (I), additions (II)) or replace a gene from plant s own gene pool Insertion (SDN-3) of a gene from plant s own gene pool Insertion (SDN-3) classical transgenesis Random Insertion of gene from outside plant s own gene pool Basic Principle for regulatory Requirements Plant varieties developed through the latest breeding methods should not be subject to different or additional regulations if they could also have been produced through earlier breeding methods or by natural processes without human intervention. Principles for Regulatory Requirements The genetic variation in the final plant product is not covered under the scope of eisting regulation if: there is no novel combination of genetic material (i.e. there is no stable insertion in the plant genome of one or more genes that are part of a designed genetic construct), and; the final plant product solely contains the stable insertion of inherited genetic material from seually compatible plant species, or; the genetic variation is the result of spontaneous or induced mutagenesis

4 Directive 2001/18 on the deliberate release into the environment of genetically modified organisms Directive 2001/18 on the deliberate release into the environment of genetically modified organisms Article 2 Definitions For the purposes of this Directive: (1) (2) "genetically modified organism (GMO)" means an organism, with the eception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; Article 3 Eemptions 1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Anne I B. ANNEX I B TECHNIQUES REFERRED TO IN ARTICLE 3 Techniques/methods of genetic modification yielding organisms to be ecluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: (1) mutagenesis, (2) cell fusion (including protoplast fusion) of plant cells of organisms which can echange genetic material through traditional breeding methods IMPACT OF CUMBERSOME REGULATIONS ON EUROPE S AGRICULTURE The Technique Conundrum Prevent esp. SME s from developing and using these methods Eroding competitiveness and leading to a less diversified plant breeding sector in Europe European scientific ecellence (private and public), related jobs, innovation and consequently economic growth driven out of Europe; Small size of niche markets would not justify the regulatory approval costs Portfolio of products reduced Less choice in products for Europe s farmers, growers, processing industries and consumers; Achieving goals of increased sustainability of EU agriculture will be put at risk Technique rdna Genome Editing Crossing & Random Selection Mutagenesis Result e.g. Low phytate Maize gmo-regulation no no yes? familiarity specificity modified according to Jeffrey D. Wolt, Regulatory Aspects of Genome-edited Crops, VISCEA Conference, Vienna, July Eplain Fuidity of Genomes and Sources of Natural Genetic Variation in Crops Communication Bring things into Contet SNPs (point mutations) presence absence or copy number variation Insertions & deletions DNA from organelles in nuclear DNA Natural Genetic Variation Transposable elements Bacterial genes crossing with wild relatives Viral genes Source: Crop Science, 57: 2906 (2017)

5 Eplain that Genome Editing allows for very precise and relatively small changes Eplain that even if Plants are non-gm, there is etensive (EU-)Regulation in Place Seed specific Rules & Possible additional private Standards & Standard Regulations for all Plant Varieties, Seeds and Resulting Products Regulations Stewardship 1) echanges 2) deletions 3) insertions Breeder Seed Producer Farmer/ Producer Trader Food Processor OECD, ISTA Global Gap ESTA General Environmental Liability Legislation Agricultural Vegetables crops DUS, DUS, VCU, Common Catalogue Common Catalogue Varieties Directives for Seed Marketing (min. product quality) and Treatment; Plant Health Regulation and official Controls Seeds Fertilizers Sustainable Use Directive Pesticides Other on Farm Quality Controls Respective Harvest regulations Grain, Vegetables etc. Food Regulations General Food Law and Product Liability Legislation GMO Directive including Labelling Organic Farming Regulation Novel Food Regulation 25 Food Communication The ESA Campaign NGOs are the new establishment We need new tools, a new structure and a new mindset 29 5

6 3 key issues 1. Food quality (meeting consumer epectations) 2. Securing Europe s food supply (natural solutions to meet food demand) 3. Resource efficient farming (safeguarding yields to reduce loss on the field) 31 The evolution of Plant Breeding Innovation- eamples More healthy and nutritious Food- eamples Resource efficiency- eamples Engage by following, liking, retweeting & Spread the news & share content using the hashtag: #EmbracingNature #PlantBreeding #Innovation

7 CONTACT US ESA European Seed Association Avenue des Arts 52 B 1000 Brussels T. +32 (0) secretariat@euroseeds.eu FOLLOW US ON 7