Emerging Biotechnology and Biosafety Policy Framework in Sub Saharan Africa:

A Pursuit of safety or a Barrier to Bio-innovation?

Jacob D.H. Mignouna, PhDAg Executive Director,

African Agricultural Technology Foundation

14 May 2011

Agricultural Biotechnology in Africa Conference, Addis-Ababa, Ethiopia

Overview

• Building partnerships-PPP- to deliver innovative technologies to farmers

Water Efficient Maize for Africa (WEMA)

Insect Resistant Cowpea

• Biosafety policies and Challenges

• Conclusion

… to facilitate access to and delivery of IP-linked agricultural technologies addressing smallholder farmers’ constraints in sub-Saharan Africa

The AATF mandate

AATF Strategic Thrusts• Negotiating access to and ensuring stewardship of proprietary

technologies that enhance the productivity of agriculture in Africa

• Managing partnerships for project formulation, product development and deployment to introduce innovative agricultural technologies to African farming systems

• Managing information and knowledge to support technology identification, product development and deployment, and a conducive policy environment

Water Efficient Maize for Africa

Devastating effect of drought A good maize crop

WEMA Partners• The African Agricultural Technology Foundation

(AATF) leading the project.• CIMMYT and Monsanto providing germplasm,

breeding, and biotechnology.• National Ag. Research System (NARS) testing

products and bringing WEMA to farmers• Kenya• Uganda• Mozambique• Tanzania• South Africa

• The Bill and Melinda Gates Foundation and Howard G. Buffett Foundation providing R&D funding.

CFT visit by WEMA-SA Teams + Monsanto,21 Jan’10 (CS 14 days after last irrigation)

USDA Looks to Approve Monsanto's Drought-Tolerant Corn

The New York Times 12 May 2011 – Policy/LegislativeByline: Paul Voosen

• The Obama administration will seek to allow the unlimited sale of a corn variety genetically engineered by Monsanto Co. to resist drought, the Department of Agriculture announced today. The corn, if approved, would be the first commercial biotech crop designed to resist stressful environmental conditions like drought, rather than pests or herbicides.

Artificial infestation of MarucaCFT-2010

Regulatory Challenges

• Biosafety legislation /policy environment

• Regulatory compliance cost

CHAOS!!!!

Regulations are necessary to avoid chaos!

GM crops: Regulated Products!

• GM Crops are highly regulated products

• Handled, tested, moved and traded in

compliance with regulations

• Regulators have a national obligation to

address virtually all considerations to ensure

that activities relating to GM technology

proceed in a safe and highly responsible

manner

Challenges: Perspectives from Product developer

1. Diverse policy environment for GM crops

2. Legislation: Legislative dilema!

3. Inadequately administrative systems

4. Compliance enforcement mechanisms

5. Public engagement: A forum for anti-GM

activities

Policy Choices for GM Crops1. “Promotional” policy position

Assumes GM crops to be as safe as conventional!

2. “Permissive” policy positionApprovals made on case-by-case risk assessment

considerations e.g. South Africa, Burkina Faso, Kenya, Uganda, etc

3. “Precautionary” policy positionApprovals linked to ‘precautionary principle’ e.g. Mauritius,

Malawi, Zambia

4. “Preventive” policy positionWhere GM technology is assumed inherently too risky; e.g.

Benin, Angola

Adapted from Paarlberg (2000)

Policy on GM crops...• Most parties engaged in product development find

the operative policy environment on GM crops in Africa to contain highly precautionary overtones!

• An overly precautionary policy position is burdensome to product development and often turns away investments in GM technology

Strict Liability or Responsibility

• The biosafety legislation of certain countries give persons who believe their land or crops have been damaged by a neighbour’s transgenic crops the right to bring a claim in strict liability or responsibility

• The principle of strict liability or responsibility is not fault-based and may apply despite the exercise of utmost care on the part of the offender

• National Performance Trials/DUS 30,000 – 60,000• Application for variety release 500 – 1,000

• Total (US $) 31,000 – 61,000

Regulatory Compliance Costs: IR Maize

Regulatory Compliance Costs: Bt Maize• Preparation for hand-off of events into regulatory • Molecular characterization • Compositional assessment • Animal performance and safety studies • Protein production and characterization • Protein safety assessment • Nontarget organism studies • Agronomic and phenotypic assessments • Production of tissues • ELISA development & expression analysis • EPA expenses for PIPs (e.g., EUPs, tolerances) • Environmental fate studies • EU import (detection methods, fees) • Canada costs • Stewardship • Toxicology (90-day rat)—when done • Facility & management overhead costs

• Total (US $) 7,000,000–15,000,000Source: Kalaitzandonakes et al. 2007

20,000 – 50,000300,000 – 1,200,000750,000 – 1,500,000

300,000 – 845,000162,000 – 1,725,000

195,000 – 853,000100,000 – 600,000130,000 – 460,000

680,000–2,200,000415,000–610,000150,000–715,000

32,000–800,000230,000–405,000

40,000–195,000250,000–1,000,000

250,000–300,000600,000–4,500,000

Denying Innovations to scientists?

KU-Biotech lab KU- Biotech Greenhouse

Conclusions

• Development, deployment and adoption of new agricultural Bio-technologies will play a role in increasing productivity

• Acting responsibly throughout the technology value chain is essential to minimize liabilities

• Partnerships are essential for bringing about innovations• It is essential for African countries to understand the

importance of minimizing the cost of regulations in order to maximize the benefits from biotechnology; positions taken by other regions may not necessarily be in the best interest of Africa

• Time is running out; action is needed … NOW!

FONDATION AFRICAINE POUR LES TECHNOLOGIES AGRICOLES

Thank you!