“Agricultural Biotechnology and GMO’s : National and International Structures”

1. “Agricultural Biotechnology and GMO’s : National and International Structures” Johan Brink, Institute of International Agriculture Michigan State University National Extension Conference Michigan State University 24 -27 March 2003

2. Agricultural Biotechnology 1st Generation Biotechnology • producing wine, beer, cheese, vaccines 2nd Generation Biotechnology • conventional breeding, tissue culture techniques 3rd Generation Biotechnology or “Modern Biotechnology • recombinant DNA technology, GMO’s, genomics

3. Agricultural Biotechnology Modern Biotechnology – GM products • is not a silver bullet or a quick fix to solve the world’s poverty and food security problems • when combined with conventional approaches, it can go a long way in the improvement of crop productivity • does require a new way of thinking, organization and communication

4. Comprehensive Approach to Agricultural Biotechnology Agri Industry Outreach Economic Growth Food Security Improved Nutrition Public Outreach Market/Trade R & D Technology Transfer Extension & Stewardship IPR Outreach & Communication Farmers Technology Seed Indus. Biotech Indus. Regulatory Framework Varietal Release Biosafety PVP/IPR Food & Environmental Safety Conventional Breeding

5. Major Policy Issues in Agricultural Biotechnology Biosafety • Food Safety • Environmental Safety • Regulatory Frameworks • Food Aid Intellectual Property Rights/Plant Variety Protection • Patenting of technology, processes and products

6. Major Policy Issues in Agricultural Biotechnology International Trade • Labeling • Export markets to Europe • Treaties : Cartagena Protocol on Biosafety; Codex allimentarius; WTO rules • Globalization and control of the world’s food supply by multi-national companies

7. Major Policy Issues in Agricultural Biotechnology Communication & Outreach • Public awareness & acceptance • Policy maker awareness • Agricultural Industry awareness • Consumer benefits • Trust in science and regulatory system • Newsworthiness of GM foods

8. Major Policy Issues in Agricultural Biotechnology Public/Private Sector partnerships and Linkages • Private sector concentrate on major crops such as corn, soybean, cotton • Public sector concentrate on papaya, potato, cassava, sweetpotato, banana, etc. • Private sector has deep pockets to comply with regulatory requirements

9. Biotechnology Policy : Challenges and Constraints in Developing Countries • No strategies for Communication and Outreach – Policy maker awareness and Public awareness • Lack of Human Resources with expertise in Biotechnology related policies • Lack of Financial resources to develop and implement policies • Lack of political will to adopt biotechnology and address crop productivity • Limited number of countries developed and implemented national biotechnology strategies • Lack of viable seed industries

10. Biotechnology Policy : Challenges and Constraints in Africa • Lack of co-operation among Government Ministries regulating biotechnology derived products • Lack of Public-Private sector partnerships that are critical to both R&D and “commercialization” • International Trade barriers • Food Aid Issues • Compliance with/to International Protocols/Treaties • Lack of Infrastructure and Institutional Support Structure eg. Biocontainment facilities, PVP/Patent offices, Food safety labs • Lack of Risk Assessment Capacity and expertise

11. Elements of a Biosafety Framework to regulate GM products • Legislative component – GM act or law passed by Parliament • Specific GM regulations – linked to the GM act and to be implemented and administered by a Government Department • Biosafety Framework implemented to : - Assess Scientific Risk of GM product - Assess Socio-Economic impacts - Ensure Public Communication,

12. Biosafety Framework in South Africa • GMO Executive Council • Representatives from Depts. Of Agriculture, Science & Technology, Environmental Affairs, Health, Labor, Trade & Industry, Water Affairs & Forestry • Duties: • To advise the Minister of Agriculture on all aspects concerning the development, production, use, application and release of GM Product • To assess the potential Socio-Economic impact of the GM Product • To communicate and interact with the public Scientific Advisory Committee Duties: - Risk Assessment and Management - Appoint Scientific Review Panel Communication with Public GMO Registrar : Department of Agriculture Duties: Biosafety Administration Monitor all GMO facilities and activities Routine inspections Appeal Board Application for GMO Permit for Field test

13. Current Status of Biosafety in Africa

14. Current Status of Biosafety in Africa:2002

15. Regulatory Framework in the USA GM products are regulated by 3 different agencies • Department of Agriculture (USDA) – oversees safety for cultivation • Environmental Protection Agency (EPA) – oversees the safe use of pesticides, including pesticides produced in GM plants • Food and Drug Administration (FDA) – ensures products are safe to eat and addresses food labeling issues

16. Roadmap for Commercialization of a GM Product • R&D – Technology Development, Field Tests and establish Proof of Concept • Product Development – Multi-location field trials, cultivar development and bulking-up of material • Regulatory File Development – Perform Food safety analysis (allergenicity, toxicity and nutritional composition) and environmental studies (outcrossing potential, effects on non-target organisms, etc) • Obtain “Freedom to Operate” – “Who owns the Intellectual Property of all the components of the product (gene, promoter, variety etc.)?” • Dissemination strategy – “How will product reach the farmer?” ; “Will private sector seed companies be involved?” • Extension – “ How do farmers grow and cultivate the product?” • Stewardship and Liability – Management of the product by farmers, processors and exporters • Public Communication of benefits, impacts

17. Source : Clive James, ISAAA

18. Global adoption of GM Crops : 2002 Source : Clive James, ISAAA

19. GM Crops planted in the USA : 2002 Source : Clive James, ISAAA

20. Dominant Transgenic Crops :2002 Source : Clive James, ISAAA

21. Global Adoption Rates of GMO’s Source : Clive James, ISAAA

22. GM Crops planted in the USA : 2002 • Planted 39 million ha (66% of total ha) • Soybean (HT), Corn (IR;HT), Canola (HT), Cotton (IR;HT), Stacked traits • Net gain of 3.3 million ha in 2002 • 79% of national soybean area planted to herbicide tolerant RR soybean • Increase in planting of Bt Corn in 2002 • 10% Decrease in planting of GM cotton Source : Clive James, ISAAA

23. More information on GM Crops • International Service for the Acquisition of Agri-Biotech Applications (ISAAA) http://www.isaaa.org • Crop Biotech Net - ISAAA Global Knowledge Centers http://www.isaaa.org/kc • Agricultural Biotechnology Support Project (ABSP) at Michigan State University http://www.iia.msu.edu/absp

24. What is “ABSP” • The Agricultural Biotechnology Support Project (ABSP) is a USAID-funded project based in the Institute of International Agriculture at the Michigan State University • Since 1991 ABSP, in collaboration with other US universities and the private sector, has integrated research, product development and policy/regulatory development to assist developing countries in accessing and generating biotechnology and in establishing a regulatory framework for the adoption of biotech crops

25. What is “ABSP” • ABSP focused on GM applications in potatoes, cucurbits, corn and tomatoes • Capacity building in: R&D, Intellectual Property Rights (IPR), Technology Transfer and Biosafety • Partner Countries: Costa Rica, Egypt, India, Indonesia, Kenya, Morocco, South Africa • Regional Partners: East and Central Africa, Southern Africa

26. Development of tuber moth resistance in potatoes : ABSP, MSU & AGERI

27. ABSP : 1991 - 2003 networking ABSP is a successful model for Agricultural Biotechnology development policy research management

28. Fire Damage to ABSP Offices January 1, 2000 • Arson attack on ABSP offices in Agriculture Hall, MSU • Earth Liberation Front (ELF) • claim responsibility for fire damage

29. Thank you for your attention ! http://www.iia.msu.edu/absp

30. Europe and GMO’s • Cultural differences ; traditional agriculture system • Small continent and countries ; ecologically vulnerable • Science is criticized and scientists are not trusted • No pressure to improve crop productivity • Food scandals in Europe ; BSE etc. • The role of the media in communicating the biotech message ; “Bad news is not good news” ; GM foods less newsworthy in recent months • Public perception and acceptance