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 called genetic 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 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
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. Monitoring and Surveillance of Biosafety Facilities
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

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
NPTs, VARIETY DEVELOPMENT & SEED INCREASE
High Quality
Desired Quantity
Right Time
KALRO
BSL2: Lab.
COMMERCIALIZATION

23. THANK YOU