1. Case Description: The Regulatory Strategy for Stacked Soybean Miguel Alvarez Arancedo Asociación Semilleros Argentinos (ASA) 17 September 2012 1

2. Bt/RR2Y Soybeans Provide Combined Insect Protection and Herbicide Tolerance  30 M Ha are infected by Lepidopteran pests in Brazil/Argentina – Primary target markets  Complete insect control demonstrated in multi-year field trials  Potential to reduce insecticide applications while showing significant yield protection vs. current insecticides  Combined with RR2Y trait to provide excellent tolerance to glyphosate Velvet Bean Caterpillar (Anticarsia gemmatalis) Soybean Lopper (Pseudoplusia includens) Alfafa Looper (Rachiplusia nu) Bud Borer (Epinotia aporema) INTACTA RR2 PRO ™ Trait Protection 2

3. CropLife International General Policy CropLife International believes in access to the shared benefits of crop biotechnology. To help ensure the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, CropLife International supports actions that facilitate the flow of goods in commerce and minimize trade disruptions. CropLife International believes that henceforth individual member companies should, prior to commercialization meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems and are likely to import the new biotechnology-derived plant products. Industry Launch Policies 3

4. 4 Soybean Trade Flows Source: Food and Agribusiness Research & Advisory, Rabobank International (2009)

5. Global Regulatory Submissions Bt/RR2Y Soybean Country or Region Total Export Share* % BRZ – ARG Regulatory Framework Bt soybean submission Bt/RR2 submission China4528 YesOct. 2010* EU3528 YesMay 2010Aug. 2009 Korea3.21.5 Yes (5 agencies) Feb-Mar. 2010Oct.-Nov. 2011 Taiwan1.4<1 YesNov. 2009July 2011 Japan1.2<1 Yes (3 agencies) Dec. 2009- Mar. 2010 Dec. 2010; July 2012 Thailand5.6<1 evolvingOct. 2009- Indonesia<14.2 evolvingMar. 2011- India<12.9 evolvingOct. 2010 5 Additional submissions made to potential importing countries Australia/NZ; Canada; Colombia; Mexico; Philippines; Russia; Singapore, United States. Potential production countries Paraguay, Uruguay. Total – 40+ submissions BrazilProduction YESJune 2009 Argentina Production YESDec. 2010 Production Approval: Aug. 2010 Aug. 2012 * 2010 figures based on total export volume beans, meal, oil

6. Industry Efforts to Achieve Synchrony and Avoid Potential Trade Disruption  Regulatory submissions made in rapid succession starting in targeted production geographies then key export markets with functioning regulatory systems  Submissions to export markets made based on market assessment and dialogue with value chain and Gov. for crop in question  Submissions comply with national data requirements – based on recent experience and, where possible, regulator feedback  Responses to regulatory questions are handled as quickly as possible; Stack submissions made as soon as possible  Commercial introduction after meeting applicable regulatory requirements from key countries most likely to import biotechnology-derived plant products 6 The elements above are captured in various stewardship policy statements (Excellence Through Stewardship, CLI, BIO)

7. Challenges to Synchronicity  Regulatory requirements shift and vary over time and within a country  Complexity and diversity of data requirements between countries  Multiple reviews occurring simultaneously in some markets;  Submissions and reviews may run sequentially (i.e., single then stack) within a country; some countries require approvals in other markets  Emergence of new or evolving regulatory systems  Technical reviews and approvals impacted by politics Bottom line – Predictability of review process varies significantly Opportunities for Greater Synchrony  Assure adequate resources/training is available to achieve target review timelines  Streamline processes and reduce redundancies; year round submissions; worksharing or joint reviews; Parallel reviews  Harmonized data requirements; Mutual acceptance of data/data reviews 7

8. 8 Thank you