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SECOND INTERNATIONAL MEETING ON LOW LEVEL PRESENCE Rosario, September 17, 2012

SECOND INTERNATIONAL MEETING ON LOW LEVEL PRESENCE Rosario, September 17, 2012. Current situation and causes of asynchronous approvals Efforts to avoid trade issues Juan Kiekebusch, Argentine Seed Association. Current status of GM crops (2011). Soybean - Maize Cotton - Canola

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SECOND INTERNATIONAL MEETING ON LOW LEVEL PRESENCE Rosario, September 17, 2012

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  1. SECOND INTERNATIONAL MEETING ON LOW LEVEL PRESENCE Rosario, September 17, 2012 Current situation and causes of asynchronous approvals Efforts to avoid trade issues Juan Kiekebusch, Argentine Seed Association

  2. Current status of GM crops (2011) Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Herbicide tolerance Insect resistance Virus resistance - Color 29 countries, 16.7 MM growers, 160 mi hectares Source: ISAAA

  3. What’s coming next? More hectares, more countries and more farmers 160 MM hectares 29 countries 16.7 MM growers 200 MM hectares 40 countries 20 MM growers Source: ISAAA

  4. What’s coming next? More GM products In 2015, 120 events are expected to be commercialized Sources: Agrilife-JRC

  5. What’s coming next? More GM crops Today ≤5 years >5 years Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Soybean - Maize Cotton - Canola Alfalfa - Sugar beet Papaya -Squash Poplar - Carnation Commercial GM crops Commercial and regulatory pipeline Rice - Bean Potato - Eggplant Plum Rice - Bean Potato - Eggplant Plum Sugar cane - Wheat Tomato - Cassava Cabbage - Okra Cauliflower Mustard - Peanut Sweet pepper R & D pipeline Sources: CropLife, Agrilife-JRC

  6. What’s coming next? More GM traits Today ≤5 years >5 years Herbicide tolerance Insect resistance Virus resistance Herbicide tolerance Insect resistance Virus resistance Herbicide tolerance Insect resistance Virus resistance Commercial GM traits Drought tolerance Higher yielding Crop composition (beta-carotene, fatty acids, starch, lignin) Drought tolerance Higher yield Crop composition (beta-carotene, fatty acids, starch, lignin) Commercial and regulatory pipeline Stress tolerance Nitrogen use Improved feed Increased ethanol Fungal resistance Nematode resistance Disease resistance R & D pipeline Sources: CropLife, Agrilife-JRC

  7. What’s coming next? More developers and countries of origin • Some examples of local developments in the commercial or regulatory pipeline: • Soybean – imidazolinone tolerance (EMBRAPA/BASF - Brazil) • Bean – virus resistance (EMBRAPA – Brazil) • Plum – virus resistance (USDA/ARS – US) • Rice – beta carotene, Golden Rice (IRRI - Philippines) • Eggplant – insect resistance (Maharashtra Hyb Seeds Co – India) • Maize – crop composition, phytase (CAAS – China) • Potato – virus resistance (Tecnoplant – Argentina) Most likely “isolated/foreign approvals” with authorization only sought in cultivation markets Sources: CropLife, Agrilife-JRC

  8. What’s coming next? 3 maize 1 soybean 1 cotton More and faster commercial approvals in exporter countries BR 8 maize 1 soybean 2 cotton 18 maize 5 soybean 12 cotton 1 bean ARG BR 2007 20 maize 4 soybean 3 cotton ARG 2012

  9. More cultivation More products More crops More traits More local developments More and faster approvals in exporter countries More burden on regulatory agencies worldwide + • Differences in regulatory processes and times • High regulatory costs More asynchronous approvals

  10. Why synchronicity is so important? Supply Demand Food & feed exporters Food & feed importers New technology Synchronous approvals More and better food Same price Sustainability Product launch Regulatory approvals Regulatory approvals Political will  Gov/industry coordinated efforts  Proactive farming and agribusiness sectors 

  11. Why asynchronicity is so disruptive? Supply Demand Food & feed exporters Food & feed importers New technology Asynchronous approvals + Zero tolerance for LLP DELAYED More and better food same price sustainability Product launch Regulatory approvals Regulatory approvals Despite… Political will  Gov/industry coordinated efforts  Proactive farming and agribusiness sectors 

  12. Asynchronous approvals and zero tolerance policies for LLP cause trade disruptions and delays in commercialization and accessing new technologies • Synchronize approvals • Implement pragmatic LLP policies

  13. Seed Marketing & Distribution Seed Production Crop Production Plant Development Crop Utilization Gene Discovery Product Discontinuation What is industry doing? • Stewardship - the responsible management of the biotech products across the full life cycle, including the implementation of appropriate programs and processes to manage product integrity, product launch and commercialization activities • Timing of submissions • Working with Government and other stakeholders to encourage national solutions to avoid trade disruption due to LLP in seed and FFP

  14. How Governments could help minimize trade disruptions? • Continue transparency in regulatory requirements • Predictability in timelines for decision-making • Working at bilateral and regional level to synchronize approvals and develop practical LLP policies (mutual recognition of approvals or risk assessments can be an important step forward).

  15. Synchronicity is already in the agenda of LATAM countries 18 maize 5 soybean 13 others 2012 BR 1 soybean 1 others 27 maize 5 soybean 9 others 54 maize 11 soybean 41 others COL MEX PY Approvals for commercial planting in Mercosur countries 20 maize 4 soybean 3 others 7 maize 1 soybean UY ARG (at least 5 new maize and 1 soybean events are in the advanced regulatory pipeline in Paraguay and Uruguay) Approvals for FFP in Mexico and Colombia

  16. Conclusions • Modern biotechnology is here to stay and is crucial to respond to the global demand for food and feed. • Despite developers’ efforts to obtain timely approvals in major markets, asynchronous approvals will increase. • Despite stewardship, best management practices and quality control systems, LLP = 0 is not possible to reach. • Both asynchronous approvals and zero tolerance policies cause trade disruptions and delays in commercialization and accessing new technologies. • Pragmatic LLP policies are needed to minimize trade disruptions, rapidly and safely respond to LLP incidents and establish clear rules for the industry activities. • A joint effort by importer and exporter countries is crucial to achieve synchronous approvals, as the ultimate goal to really avoid trade disruptions

  17. A final thought… Argentina produces now enough food to feed 400 million people – 10 times its population – and the global population growth and food demand will make Argentina increase that to 650 million by 2020. To do so, Argentina needs to introduce new technologies allowing sustainable and high-intensity crop production, with biotechnology being essential for both sustainability and intensification. Importer countries should support the adoption of such new technologies to benefit both importer and exporter countries, assuring food supply. Synchronization of GMO approvals will be a big step forward in achieving this objective.

  18. Thank you for your attention! Juan.kiekebusch@syngenta.com

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