Getting Technologies to Farmers -- Fixing Regulatory Systems for Agricultural Technologies

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Panel Presentation: Getting Technologies to Farmers -- …

Panel Presentation: Getting Technologies to Farmers --
Fixing Regulatory Systems for Agricultural Technologies by
Judith Chambers, Ph.D., Director – Program for Biosafety Systems at IFPRI. Presented at Food Security in a World of Growing Natural Resource Scarcity event February 12, 2014.

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  • 1. Food Security in World of Changing Climate and Natural Resource Scarcity: The Role of Agricultural Technologies Panel Presentation: Getting Technologies to Farmers Fixing Regulatory Systems for Agricultural Technologies Judith Chambers, Ph.D. Director – Program for Biosafety Systems Newseum Conference Center February 12, 2014
  • 2. Factors Influencing Farmer Access • Market systems and forces • Infrastructure • Institutional factors (i.e. extension, public vs. private sector) • Intellectual property rights • Regulatory/Biosafety Policies
  • 3. Conventionally Bred Varieties Introduced with Minimal “Safety Review” • Evaluated for efficacy/performance to assess the desired trait or traits that was the objective of the breeding event • New variety not evaluated from a safety perspective as it is “assumed” to pose no additional health or environmental risk since the genetics are manipulated within the species
  • 4. Crop Protection Products Evaluation of crop protection chemicals for environmental and human/animal health safety • recognized part of the product development cycle • costs and time for evaluating the toxicological profile of these chemicals are factored in to the overall product development cost and cycle
  • 5. GM Crop Varieties Regulatory factors have been a rate limiting step in introduction and farmer access despite: • Nearly 2 decades of safe use • FASTEST ADOPTED AG TECHNOLOGY IN HISTORY Biotech crop hectares increased 1000 fold from 1.7 M (1996) to 170 M (2012) (ISAAA, 2013)
  • 6. $$$$ TIME NEW SKILLS UNIQUE CHALLENGES FOR GM CROPS REGULATORY IPR OUTREACH STEWARDSHIP
  • 7. General Product Development Cycle Slide Courtesy of Donna Ramaeker-Zahn 1 – 3 years 1 – 3 years 1 – 3 years Product Concept Discovery Early Product Testing & Development Integration & Product Selection Product Ramp Up Market Introduction Post Market Activities 1 2 3 4 5 6 CFTs Stakeholder Engagement Intensity
  • 8. Biotech Crop Countries and Mega-Countries, 2012
  • 9. Impact: India emerged as 2nd largest exporter of cotton Source: Cotton Advisory Board 2009
  • 10. India: Bt Cotton contributed to doubling of yields in 5 years Source: Cotton Advisory Board
  • 11. Page 11 Impact at the Farm Level: Average effects of Bt cotton vs non-Bt in India Yield Increase 39%* Reduction in insecticide sprays 33%* Profit Increase/ha 70.9%* * Significantly different from zero at 5% level Source: Gruere, Mehta-Bhatt and Sengupta 2008 Based on peer-reviewed published studies
  • 12. Current Status in India GM Moratorium No additional products approved
  • 13. CONTROVERSY AND NON-SCIENCE ISSUES HAVE IMPACTED REGULATORY PROCESS FOR GM TECHNOLOGIES • Trade competition and retaliation • First generation products without direct consumer benefit • Technological disparity • Science literacy • Religious and cultural concerns • Food system control, consumer right to know • Cartagena Protocol – expanded scope; de facto regulatory system RESULT TRADE DISRUPTIONS, MARKET REJECTION, REGULATORY IMPACT AND DELAY !!!!
  • 14. Regulatory Delays and Inefficiencies – A “Chilling” Effect in Africa
  • 15. • Despite growing technical capacity and products in development (often from public/private partnerships) – uneven progress • Stuck on the CFT treadmill—still no commercial products after nearly 15- 20 years of biosafety work • Regulatory system--  Expensive; time consuming; unpredictable (subject to political “whimsy”)  Often heavily focused on risk; doesn’t reflect global experience and evolving science  Lack of product experience to test system  Problematic provisions (liability, socio-economics) -- a disincentive to technological progress  Inter-ministerial turf  Lack of capacity and resources  Lack of access to accurate information esp. for the political process  Lack of political will to move forward Biosafety Issues and Impacts on Adoption In Developing Countries
  • 16. Focus of Biosafety Capacity Building • Start from a perspective of Goals/Objective and Strategy • Legal framework development and adopted policy • Regulations • Theory and practical training – workshops, study tours, one on one advisory services • Practical experience – dossier reviews, field tests, de- regulation, monitoring, inspections • Reconciliation with other laws • Communications and outreach • Understanding of political process • Broad ministry focus – Agr, Env, S&T, Health, Trade, Judicial
  • 17. Remedies for Ineffective Regulatory Systems • Integrated approach – technical, legal, communications, research • Capacity building • Strategy and innovative problem solving • Relationship building • Patience; long term engagement • Policy voice from broad-based stakeholder groups and coalitions • Involvement of women • Harmonization • Reposition or redefine international/regional regulatory frameworks (Cartagena Protocol, AU Model Law)
  • 18. THANK YOU!!!!!