Food Security in World of Changing Climate and Natural Resource Scarcity:

The Role of Agricultural Technologies

Panel Presentation: Getting Technologies to FarmersFixing Regulatory Systems for Agricultural Technologies

Judith Chambers, Ph.D.Director – Program for Biosafety Systems

Newseum Conference CenterFebruary 12, 2014

Factors Influencing Farmer Access

• Market systems and forces• Infrastructure• Institutional factors (i.e. extension, public vs.

private sector)• Intellectual property rights

• Regulatory/Biosafety Policies

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

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

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)

$$$$ TIME NEW SKILLS

UNIQUE CHALLENGES FOR GM CROPS

REGULATORY IPR OUTREACH STEWARDSHIP

General Product Development CycleSlide 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

Biotech Crop Countries and Mega-Countries, 2012

Impact: India emerged as 2nd largest exporter of cotton

Source: Cotton Advisory Board 2009

India: Bt Cotton contributed to doubling of yields in 5 years

Source: Cotton Advisory Board

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

Current Status in India

GM Moratorium No additional products approved

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 !!!!

Regulatory Delays and Inefficiencies – A “Chilling” Effect in Africa

• 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 InDeveloping Countries

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

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)

THANK YOU!!!!!