ROLE OF KEPHIS IN SAFE HANDLING, TRANSFER AND USE OF GMOS.

1. ROLE OF KEPHIS IN SAFE HANDLING, TRANSFER AND USE OF GMOS. By Margaret Wanjiku KEPHIS, Nairobi

2. What is a GMO? GMO From Dictionary.com genetically modified organism: an organism or microorganism whose genetic material has been altered by mean of genetic engineering. Genetic engineering, also calledgenetic modification, is the direct manipulation of an organism's genome using biotechnology

3. Basic steps in genetic engineering • Isolate the gene • Insert it in a host using a vector • Produce as many copies of the host as possible • Separate and purify the product of the gene

4. Step 1: Isolating the gene

5. Step 2: Inserting gene into vector Vector – molecule of DNA which is used to carry a foreign gene into a host cell

6. Detection

7. Transformation steps- regeneration

9. Herbicide tolerance - crop can withstand herbicide applications • Insect tolerance - plant produces toxin to kill pest • Improved nutrition – plant produces a substance of nutritive value or is changed to not produce an antinutrient • Disease resistant – crop is resistant to certain disease • Stress Tolerance – crop is tolerant of stress, low nutrient levels or excess nutrients • Increased Storage – crop can be stored longer to avoid spoilage losses • Medicinal uses – crops that produce medicines or vaccines • Industrial uses – crops to make more efficient industries

10. What crops have a GMO trait? What do the traits do and what is the benefit of these traits?GE Crops that have been commercialized in US

11. ROLE OF KEPHIS IN SAFE HANDLING, TRANSFER AND USE OF GMOS All countries that are signatory to the Cartagena Protocol on Biosafety, require to put in place mechanisms to regulate GMOs. As a regulatory agency under the Biosafety Act, KEPHIS together with the lead Agency - National Biosafety Authority (NBA), regulates safe handling, transfer and use of plant genetic modified materials in Kenya. KEPHIS has been involved in the trials of GMOS since the 1990's when modified plants were first tried in the country. The institution also played a critical role within the National Biosafety Committee, Institutional Biosafety Committees and now the National Biosafety Authority as a regulatory agency

12. Mandates of KEPHIS: • Vigilance on matters of plant health and quality control, plant variety, Seed inspection and certification. ( Issuance of plant import permit including for GMO). • Liaison with NBA for oversight of plant related Biosafety regulations. • Safeguard against importation of unauthorized articles (plants and bio-control agents) into Kenya. • Member of NBA, KSTCIE, National Codex Committee, National Food Safety Coordination Committee, IBCs • Laboratory services to ensure compliance with permit conditions • Release of new varieties is undertaken according to the variety release system

13. LABORATORY ANALYSIS A laboratory for screening plant material was established since 2005 and continues to serve with an expanded mandate • World Class laboratory at KEPHIS Headquarters • Plant Health Laboratory Molecular laboratory (Realtime PCR, Conventional PCR, ELISA, Rapid Kits) • Food microbiology laboratory • Analytical Chemistry Laboratory

14. Analytical Methods For GMO Detection • Detection – objective is to determine if a product contains GMO or not. • The result is a positive/negative statement. • Identification – purpose is to find out which GMO is present and if they are authorized or not. • Quantification – determination of amount of the GMO and assess compliance with the threshold regulation

15. Protein-Based GMO Detection Protein-Based GMO Detection Immunoassays a) ELISA b) Lateral Flow Strip • Protein based • Easy to perform, cheap and reliable • Test results within few minutes • Best for raw agricultural commodities • Identification of a specific event not possible

16. Qualitative PCR for GMO Detection -results

17. Real Time PCR - GMOs Detection Thresholds

18. SURVEILLANCE • All importation and use of GM plants has to meet Phytosanitary and Biosafety standards • All GMO activities have to first be approved by the National Biosafety Authority (NBA), followed by Phytosanitary compliance. • Research activities involving GMOs undertaken in the country have to be monitored to for compliance. • Surveillance of GMO IN KEPHIS • Surveillance of plant imports to ensure that ordinary plant permits are not used to import GMOs • Seed Quality compliance to ensure unapproved genetic elements are not released to farmers • Variety release are tested for their genetic purity and conformance to biosafety guidelines • Border surveillance is undertaken in collaboration with NBA

19. Confined Field Trials (CFT) conducted for a number of GM crops since 1991 when the first CFT (sweet potato) was initiated. • Now there is a specific law and regulations as well as Standard Operating Procedures • Isolation maintained • Protection from animals, man, environment during trials Monitoring and Surveillance of Biosafety Facilities

20. Biosafety level 2 facility at ILRI - BecA BL2GH at KARLO Biotechnology Centre

21. REVIEW OF DOSSIERS • Participates in development of ISO – Standards and review of risk assessment for applications of introduction and research of GMO • Adaption • Adoption • KEPHIS has developed guidelines for conducting National Performance Trials (NPT) for GMO plants.

22. Stages in GM-Product Development Environmental Release Contained-use CFT BSL2: Green / Screen house KALRO BSL2: Lab. • NPTs, VARIETY DEVELOPMENT & SEED INCREASE • High Quality • Desired Quantity • Right Time COMMERCIALIZATION

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