Evolution of GM crop development from the 1990s to today; Future challenges: Pipeline products; Next generation GMOs and impacts on seed testing

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Henry Harris
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1 Evolution of GM crop development from the 1990s to today; Future challenges: Pipeline products; Next generation GMOs and impacts on seed testing ISTA meeting, Montevideo, 2015 Dr. Ray Shillito, Bayer CropScience, USA Page 1

2 From the 1990s 1970 s to today; Page 2

3 Three key elements led to the first developments in Ag. Biotech Agrobacterium tumefaciens Plant Tissue Culture Molecular Biology and Biochemistry Page 3

4 The Initial Development of Plant Biotechnology occurred in the 70 s and 80 s in both the EU and USA. Page 4

5 Critical Technologies DNA discovered 1972 Discovery of restriction enzymes DNA cloning 1928 demonstration of bacterial transformation Structure of DNA solved 1976 DNA Sequencing Moratorium Southern blotting 1994 Agro transformation of Monocots 1984 Oligomer biosynthesis 1987 Gene Gun 1983 PCR invented Agrobacterium- transformation using disarmed vectors Transformation without Agrobacterium Page 5

6 Some of the Technologies with Direct Impact Selectable markers Tissue culture Protoplasts/PEG/electroporation Agrobacterium tumefaciens Biolistics Whiskers Agrobacterium in monocots A188 (3 way sweet corn cross) PCR Codon optimization Antisense / RNAi Bt proteins Cre/Lox etc. Page 6

7 Page 7 The view from 1996 was like this..

8 Key US Regulatory Approvals of Biotech Products 1992 FlavrSavr Tomato FDA 1994 Bt176, (EPA), 1995 (USDA, FDA) 1994 Bromoxynil cotton 1994 RR soybean (USDA), 1995 (FDA) NewLeaf Potato, USDA, EPA, FDA 1995 T25 LL Corn 1995 RR Canola 1995 Mon810 (USDA, EPA), 1996 (FDA) 1996 Papaya, Bt InVigor Canola (1996 in Canada) 1998 RR Sugarbeet (FDA), 2005 (USDA) 1999 LL62 Rice Page 8

9 Biotech Products and Cultivation in Europe Key Events 1997 Bt 176 Approved for cultivation 1998 Mon810 and T25 Approved for cultivation Food safety issues as a driver: First case of Mad cow disease in Europe Dioxin contamination (animal feed) scandal hits Belgium Coke products withdrawn in Belgium due to bad CO2 EU Moratorium on approvals Amflora potato approved for cultivation Page 9

high and remained high, but the product was never profitable (because

10 Products that have come and Gone Although Approved Consumers may never see a product or not for long Demand for the FLAVR SAVR tomato was high and remained high, but the product was never profitable (because it wasn t in the right varieties and was difficult to get to market) Page 10

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14 Global Area (Million Hectares) of Biotech Crops, 2014: by Country

15 Diversity of Biotech Products Others 1% Canola 9% Cotton 14% Maize 30% Soybean 50% Clara Rubenstein, Pioneer, a DuPont Company Major Biotech Crops Maize Soybean Cotton Canola Other Biotech Crops Sugar beat Alfalfa Papaya Eggplant Squash Potato Melon Sugarcane Wheat

16 Global Adoption Rates (%) for Principal Biotech Crops (Million Hectares, Million Acres), 2014

17 Country Value (USD million) Country Value (USD million) USA 12,000 Morocco 140 China 9,950 Switzerland 140 France 2,800 Bulgaria 120 Brazil 2,625 Chile 120 Canada 2,120 Nigeria 120 India 2,000 Serbia 120 Japan 1,350 Slovakia 110 Germany 1,170 New Zealand 100 Argentina 990 Uruguay 96 Italy 767 Ireland 80 Turkey 750 Paraguay 80 Spain 660 Portugal 80 Netherlands 590 Algeria 70 Russian Federation 500 Kenya 60 United Kingdom 450 Iran 55 South Africa 428 Israel 50 Australia 400 Tunisia 45 Republic of Korea 400 Bolivia 40 Mexico 350 Colombia 40 Czech Republic 305 Slovenia 40 Hungary 300 Peru 30 China, Taiwan 300 Zimbabwe 30 Poland 280 Malawi 26 Sweden 250 Libya 25 Romania 220 Saudi Arabia 20 Denmark 218 Zambia 20 Greece 200 Philippines 18 Belgium 185 Ecuador 15 Finland 160 Tanzania 15 Austria 145 Uganda 10 Egypt 140 Dominican Republic 7 Total USD 44,925 million (2013 figures) The commercial world seed market is assessed at approx. USD 45 billion Seed testing is important 6 of the top 10 commercial markets for seed are growing Biotech crops Data from: ISF 2014 ISAAA 2014

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19 Pipeline Products Page 19

Challenges for Agri-Businesses Limited arable land coupled with rising demand Safeguard and increase yields from constant land area better resource management (targeted use of crop protection,

20 Challenges for Agri-Businesses Limited arable land coupled with rising demand Safeguard and increase yields from constant land area better resource management (targeted use of crop protection, irrigation technology and fertilizers) increase yields through innovative technologies (hybridization, plant biotechnology) Expand agricultural production in marginal areas new crops with greater tolerance of drought and extreme temperatures Climate change Increase tolerance of plants to climatic variability develop new varieties using state - of - the - art technologies improve plant health and nutrient uptake Research and innovation are the key to mastering the challenges of the New Ag Economy Page 20

Industry investing in multiple modes of action, 1996-2020 (as of 2014) CORN SOYBEANS COTTON WEED CONTROL ABOVE GROUND PESTS BELOW GROUND PESTS Glufosinate-tolerance

Glufosinate-tolerance Gen2 q HPPD tolerance q PPO tolerance Glufosinate-tolerance Glyphosate-tolerance q 2,4-D tolerance q Dicamba tolerance q HPPD tolerance Commercial offering

protection Bollworm protection Gen1 Bollworm protection Gen2 Bollworm protection Gen3 q Bollworm protection Gen4 q Lygus protection q Future or potential offering Rootworm

21 Industry investing in multiple modes of action, (as of 2014) CORN SOYBEANS COTTON WEED CONTROL ABOVE GROUND PESTS BELOW GROUND PESTS Glufosinate-tolerance Glyphosate-tolerance Imidazolinone-tolerance 2,4-D tolerance q FOP tolerance Glufosinate-tolerance Glyphosate-tolerance Sulfonylurea-tolerance q Dicamba tolerance q Glufosinate-tolerance Gen2 q HPPD tolerance q PPO tolerance Glufosinate-tolerance Glyphosate-tolerance q 2,4-D tolerance q Dicamba tolerance q HPPD tolerance Commercial offering Caterpillar protection Gen1 Caterpillar protection Gen2 Caterpillar protection Gen3 q Caterpillar protection Gen4 Caterpillar protection Gen1 Caterpillar protection Gen2 q Stink bug protection Bollworm protection Gen1 Bollworm protection Gen2 Bollworm protection Gen3 q Bollworm protection Gen4 q Lygus protection q Future or potential offering Rootworm protection Gen1 Rootworm protection Gen2 Rootworm protection Gen3 q Rootworm protection Gen1 q Soybean cyst nematode protection Root knot nematode protection Gen1 q Reniform nematode protection q Root knot nematode protection Gen2

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29 There are a lot of Events/Products! Crop Commer cial Events in 2008 JRC Projected Commercial Events in 2015 Possible Commercial products in 2014 Approved historically for cultivation (inc stacks) Approved historically for food (inc stacks) Soybean 1 17 ~ Maize 9 24 ~ Canola 4 10 ~ Cotton ~ Rice Potatoes Other Crops 7 23 ~ Flowers Total Source: 33 JRC Report, / ISAAA ~ ISAAA plus OECD database has 222 unique event entries

30 The wealth of new events has implications for ISTA members OECD (2013) ENV/JM/MONO(2013)19 Since it may be impossible to entirely eliminate LLP in seed, in some cases thresholds have been set to assure an acceptable and predictable supply of seeds. This has been in response to several instances where the LLP was detected at such a low level that it was technically below the level of quantification using validated protocols for testing. In these situations, testing at different stages in the seed distribution system led to conflicting results regarding the presence of LLP in seed. Recognizing the inability to entirely eliminate LLP, thresholds have also been adopted by some importing countries to avoid the reduced availability of seeds in cases where it was known that the unauthorized plant had been authorized at least in one other country.

31 The International community is discussing the issue of LLP in seeds The International Statement on Low Level Presence 12. Recognize that LLP of unapproved seed in commercial channels is also a challenge to seed trade and that it also requires collaborative efforts to address. Further collaborative efforts on seed through this initiative should be informed by the work being currently undertaken by the Organization for Economic Cooperation and Development (OECD) in this area List of countries endorsing the International Statement on Low Level Presence (2012) Australia, Argentina, Brazil, Canada, Chile, Costa Rica, Mexico, Paraguay, Philippines, Russia, United States, Uruguay, Vietnam.

32 Detection of unknowns is difficult Knut Heller, Genetically Engineered Food Methods and Detection, 2nd Edition, Wiley, 2006

33 GM testing which events? New events originating from major biotechnology providers New events arising from other sources Other events Stacked events Need efficient screening, identification and quantification methods which o are easily adaptable to the ongoing developments and o which can be easily introduced to existing laboratory infrastructures and testing schemes

34 Detection of stacks not possible Each individual event in a GM stack has a DNA or proteinbased detection method The inserted DNA of different events is usually located on different chromosomes or many millions of base-pairs apart on the same chromosome Event-specific PCR cannot bridge gaps greater than a few hundred base-pairs Therefore it is not possible with present technology to develop a molecular technique that detects the stack cf: recent EU study on analysis of stacks Page 34

35 Next generation GMOs and impacts on seed testing Page 35

36 New events are now arising from sources other than major biotech providers These come from small companies and/or government research. Products from major providers are registered in global markets Methods and reference materials are available Some other products are only registered in single countries or regionally and Methods and reference materials are not freely available Could present a challenge for detection in seeds Screening may be carried out based on knowledge of genetic elements present in the events (literature and other sources) Page 36

37 There were two main sources of early promoters: CaMV, Ti plasmid Page 37

38 The Modern Toolbox is Multidimensional: Tool DNA trait markers Benefits Can eliminate need for phenotyping of plants (MAB) Individual seed /plant testing Robotics Expression of introduced genes RNAi TALENs/CRISPRs Genome wide selection/ genotyping by sequence Page 38 Saves time/money/space/labor, increases breeding throughput Speed increase by integration of workflows in analysis of markers Biotech approach to add new genes (herbicide and insect tolerance) Biotech approach to alter biochemical pathways through the alteration of native gene expression Emerging techniques for the specific editing of native genes. Emerging technique enabled by cheap/fast DNA sequencing for the discovery of new markers for breeding, acceleration of backcrossing

39 Nucleases, TALENs and CRISPRs Chen and Lin: Promises and issues of GM crops, Current Opinion in Plant Biol., 2013 Page 39

40 Nucleases, TALENs and CRISPRs Generate ds breaks at specific locations in DNA which are repaired, leading to mutation-like changes From a detection point of view: The changes cannot be distinguished from mutations There is a discussion on whether and how these products might be considered regulated In any case we may need detection methods for purity testing Page 40

41 Detection of new GMO s Most regulations were written and adopted during a significantly simpler technology landscape. Today s reality may not have been anticipated. Screening assays based upon genetic elements will become less useful as new selectable markers, promoters and technologies are introduced. The costs and complexities to monitor seed purity will increase dramatically. Single event analysis remains methodology of choice 4 6 component stacks will become commonplace Increasing list of species as new technologies are adopted Change is inevitable

42 The Future Use of Agricultural Biotechnology continues to expand Many new events are being developed in multiple crops by both traditional biotechnology providers and new sources Events will originate from different global regions Stacked events will be more common and complex Products of newer technologies are a challenge to distinguish from natural processes Thus seed (GMOs) testing will become more complex and difficult It is important that global trade in seeds is not disrupted Reasonable Low Level Presence thresholds will be important in order to avoid trade disruptions

Pocket K No. 16. Biotech Crop Highlights in 2016

Pocket K No. 16. Biotech Crop Highlights in 2016 Pocket K No. 16 Biotech Crop Highlights in 2016 In 2016, the 21 st year of commercialization of biotech crops, 185.1 million hectares of biotech crops were planted by ~18 million farmers in 26 countries.