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GMO : from the bench to the field . a regulatory perspective. Mohamed E. Saad , Ph.D. Egypt’s National Biosafety Committee. EBIC – 24/3/2013. New disruptive technology. Commercial value. Regulation ….. Regulation ….. Regulation. The locomotive act.
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GMO : from the bench to the field a regulatory perspective Mohamed E. Saad, Ph.D Egypt’s National Biosafety Committee EBIC – 24/3/2013
New disruptive technology Commercial value Regulation ….. Regulation ….. Regulation
The Journey of a GMO The idea The proof of concept
The Journey of a GMO The idea The proof of concept Initiation of an application
Risk Assessment Food safety Environmental safety Socio-economic impact
Risk Assessment Steps Hazard identification Hazard exposure Risk management Overall risk evaluation
The Journey of a GMO The idea The proof of concept Initiation of an application Going to “the open”: Testing and trails
The Journey of a GMO The idea The proof of concept Initiation of an application Going to “the open”: Testing and trails Decision on “placing on the market”
The Journey of a GMO The idea The proof of concept Initiation of an application Going to “the open”: Testing and trails Decision on “placing on the market” Monitoring and surveillance
Article 1. • Without prejudice to other product legislation, consent is given to the placing on the market of inbred lines and hybrids derived from maize line MON 810 containing the cryIA (b) gene from Bacillus thuringiensis subsp. kurstaki under the control of the enhanced 35S promoter from cauliflower mosaic virus and an intron from the gene coding for the heat shock protein 70 from maize, as notified by Fine Seeds International, 10 Abuelethamine Square Agouza, Giza, Egypt • Article 2. • The consent covers any progeny derived from crosses of the product with any traditionally bred maize. Any new commercial names of such progeny will be notified to the NBC. • Article 3. • Vendors shall be required to label seed bags of MON 810 certified seed with the wording: “genetically modified insect resistance maize”, with its commercial name as well as with the unique identifier MON-ØØ81Ø-6, • Article 4. • The notifier referred to in article 1, shall inform the NBC by the 31 of December of each year of any information it receives in relation to the above project that could suggest: • development in the European corn borer and the Pink borer of resistance against the Bt toxin of the approved variety • effects of the approved variety on non-target insects • Article 5. • This consent shall be valid for ten years. • Article 6. • Copy of this decision shall be sent to the Seed registration Committee.