Challenges and Lessons Learnt in Commercial Release of Genetically Modified Crops- Interface between Event

Approval and National Variety Release Procedures

Silas Obukosia, Olalekan Akinbo, Doris Wangari, Godwin Lemgo, John Komen and Jeremy

Ouedraogo

Background • NEPAD Agency African Biosafety Network of

Expertise (NEPAD/ABNE) is a biosafety resource network for African regulators and policy makers.

• Conceptualized-NEPAD Agency’s Consolidated Plan of Action

• Recommendation of the High-Level African Panel on Modern Biotechnology – Freedom to Innovate, by Juma and Serageldin (2007).

NEPAD/ABNE

• Approved officially in 2008 by the African Ministerial Council on Science and Technology (AMCOST)

• To promote advancement of science and technology for agricultural development in Africa.

• Provide farmers with choice in using improved convention and Biotechnology seeds through developing functional Biosafety Regulatory Frameworks

Presentation • Product Development Pathways of GMO

• Seed Laws and National Variety Release procedures for selected African countries

• Need to interface the two processes

• Example of the process Adopted in India

• Suggestion on way forward for African Nation-

Process

Regulation Process

Proof of Concept

Regulatory Package-

Food Safety

Environmental Safety

National Biosafety Authority

Product Development

Event Approval

National Performance

Trials

Seed and or Plant Act

National Performance Trial

Committee

Distinct, Uniformity

and Distinction (DUS)

National Variety Release

Committee

Commercial Release

Commercial Release for Farmer Cultivation- Food and Nutritional

Security

Procedures for variety evaluation, release and registration

• National Seed Certification Services (NSCS)-ensures undergo National Variety Performance Trials (NVPT) for two seasons to be for commercial release commercial production.

• Variety released in another country, NVPT- at least one main growing season’

• Must provide data used for release in similar agro-ecological zones.

• National Variety Performance trials is to determine

(a) Agricultural value- compare National Check

(b) Distinctness, Uniformity and Stability (DUS)

OCED Seed Scheme • Uganda has adopted the OECD seed scheme

that recognizes five seed classes namely

• Breeder’s seed, pre-basic seed, basic seed, certified seed and standard seed. Breeder’s seed is the original nucleus seed from the breeder.

• AFTA, ISTA, UPOV, National Seed Trade Associations

Seed Laws in Selected African countries Grain-540-africa-seeds-laws-red-carpet-for corporation

TANZANIA The 2003 Seed Act foresees mandatory registration to produce, distribute (exchange) or sell seed, mandatory registration of commercial varieties for major field crops, and a national catalogue. The only mention of farm-saved seeds is in a small sub-clause, which says that the provisions of the Act do not affect the sale of Quality Declared Seeds between small scale neighbouring farmers as long as the farmer that purchases the seeds only uses them for his or her own farm.

CAMEROON The Seed Law of 2001 stipulates that all seed sold in Cameroon must be registered in the national catalogue and certified under DUS criteria. However, farm-saved seed is explicitly excluded from its scope and therefore left unregulated. The law also makes reference to the Convention on Biological Diversity, which it aims to respect, and to

Grain-540-africa-seeds-laws-red-carpet-for corporation

Event Based Approval Mechanism in India

• Applicable to NEW cotton hybrids expressing

• Four approved events including MON531 (cry1Ac gene) and MON15985 (cry1Ac and cry2Ab genes) of Mahyco-Monsanto,

• Event-1 (cry1Ac gene) of JK Agri-Genetics

• FM Event (cry 1 Ab + cry Ac genes) of Nath Seeds.

• Speed up approval of Events

• In 2008, 274 Bt cotton hybrids expressing four approved events were marketed by 30 indigenous seed companies throughout India.

http://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=3900

Event-1 (cry1Ac gene) JK Genetics • Molecular Characterization

• The composition of cottonseed and oil from Bt cotton hybrids (Event-1),

• The mammalian acute oral toxicity of Bt protein was studied in rat

• Chronic oral toxicity study on rat revealed the Cry1Ac protein found safe to animal health.

• Specificity and safety of the Cry1Ac protein was recorded.

• Nutritional Feeding studies- Efficacies studies

India Biosafety Clearing House- (http://www.indbch.nic.in/risk_assessment_jk.asp).

Environmental Safety Studies Studies done on Event-1 Compared with Convention Counterparts-

• Gene Flow studies

• Potential Weediness

• Potential Impacts on Non-Target Organisms

• Potential Impacts on Soil Microflora India Biosafety Clearing House-

(http://www.indbch.nic.in/risk_assessment_jk.asp).

GCEA Approval Process • Confirmation of gene/ event through

molecular characterization by the licensor that the gene/s which is being used is one of the approved events;

• Level of protein expression in green house and field trials;

• Morphological characters using DUS descriptors;

F. No. 13/39/2007-CS-I1 Ministry of Environment and Forests Government of India CS Division-

http://www.envfor.nic.in/divisions/csurv/geac/New%20procedure%20under%20EABM.pdf

GCEA Approval Process • Bio-efficacy data generated in Laboratory

conditions;

• Authorization certificate/ No Objection Certificate (NOe) from technology provider in case of sub-licensee; and

• The Standing Committee shall lay down rules and procedure for submission of application and conduct of the meetings

Process Applicable after the Application Passed the Test of Scrutiny:

• The new procedure shall be applicable only after the event completes three seasons of commercial cultivation.

• Once the application has cleared the scrutiny of the Standing Committee, the release of Bt cotton hybrids for commercial release in the respective state may follow the same process as that is applicable for conventional cotton (non Bt) seeds.

Experience in Kenya • Program for Biosafety Systems (PBS),

NEPAD/ABNE, KNBA, NPTC of KEPHIS, NVRC

• Workshop in Nairobi, Kenya July 28-29

• Synchronize the Process of General Release- Event approval and Commercial release of essentially derived Varieties

• Key findings- This was the first endeavour to bring the three agencies together to discuss synchrony and harmony is approval of biotechnology seeds

Workshop- NBA, KEPHIS, NPTC, NVRC

Process

Regulation Process

Proof of Concept

Regulatory Package-

Food Safety

Environmental Safety

National Biosafety Authority

Product Development

Event Approval

National Performance

Trials

Seed and or Plant Act

National Performance Trial

Committee

Distinct, Uniformity

and Distinction (DUS)

National Variety Release

Committee

Commercial Release

Commercial Release for Farmer Cultivation

Suggestions • Agencies-Biosafety/Biotechnology and NPTC and

NVRC to commence collaboration of various African countries

• Examine Biosafety Act and Implementing regulations, Seed Act and propose modalities for interface/synchrony in the activities to smoothen evaluation and approval of improved seeds for commercial release for growing on farmers’ fields

• Only then will improved biotech seeds reach small scale farmers in timely manners

Acknowledgement • Program for Biosafety Systems

• The Kenya National Biosafety Authority

• Kenya National Variety Release Committee

• The National Performance Trial Committee

• KEPHIS

• BMGF

Jean Windetongo

KEBERE (Mr) -

Communication Officer

Godwin LEMGO (Mr)

Programme Officer, Food

Safety

Tinga Jeremy OUEDRAOGO

(Dr)

Director

Ladji SIDIBE (Mr)

IT-Website Officer

Moussa SAVADOGO

(Dr) Senior Program Officer,

Environmental Biosafety

Silas Obukosia

OBWOGO (Dr)

Principal Programme

Officer - Operations

Samuel E. TIMPO (Mr)

Senior Programme Officer,

Socio-economic-Biosafety

Woldeyesus SINEBO

(Dr)Programme Officer,

Agricultural

Biosafety

Olalekan Abiodun

AKINBO (Dr)-Biosafety

Programme Officer

Oumou BARRY

SANGARE

(Mrs)Programme Assistant

Sunday Igu Rocks

AKILE (Mr)Programme

Officer, Legal/Policy

Lassina DRAME

(Mr) Madada DIAWARA

(Ms)

Finance and Admin

Assistant (Intern)

Mariam

OUEDRAOGO /

SEYNOU (Mrs)

Secretary