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.

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!!!!!