The Ban on GMO food Importation and its Implications-on research, trade and food aid

1. The Ban on GMO food Importation and its Implications-on research, trade and food aid Dr Silas Obukosia, Dr Margaret 'Karembu, Dr Christopher Ngichabe

2. Outline of the presentation • Creating and enabling environment for Biotechnology-Government • Implications of the Ban • University Education • Research • International Obligations • The Serilini Study • The Ban is relationship to the Serilini study • Open questions for discussion

3. National Biotechnology Development Policy 2006 • The NBDP approved by the cabinet last month (28 September) marks the go-ahead for the use of biotechnology in the country.

4. Kenya Government Stand on Biotechnology • The Biotechnology Policy • Biotechnology Act- (Risk Assessment) • Development of Biosafety Regulations • Vision 2030

5. Key Objectives in the Policy • Prioritize, promote, and coordinate research in basic and applied bio-sciences. • Promote sustainable industrial development for production of biotechnology derived products. • Create enabling administrative and legal frameworks for biotechnology development and commercialisation. • Develop mechanisms for the provision of sustainable funding for biotechnology research and products development. • Support and facilitate capacity building on all aspects of biotechnology including intellectual property access and protection, biosafety and bioethics. • Support the development and retention of human resources in science, innovation and biotechnology. • Stimulate collaboration among public, private sectors and international agencies in order to advance biotechnology both locally and internationally. • Promote public understanding of the potential benefits and address stakeholder concerns/issues on modern biotechnology.

6. University Education is emphasising Biotechnology

7. University of Nairobi Universities • Department of Biochemistry and Biotechnology (KU) • BSc. Microbiology And Biotechnology (UoN) • Master of science in microbiology and biotechnology, University of Nairobi

8. Center for Biotechnology and Bioinformatics CEBIB • CEBIB was founded as a virtual research centre to train postgraduate students at MSc and PhD level in biosciences (biotechnology & Bioinformatics) in the academic year 2005/2006. • The goal of the program is to develop capacity and manpower for the development of Biotechnology. • To date CEBIB is serviced by academic staff from School of Biological Sciences (SBS), School of Computing and Informatics (SCI), School of Mathematics (SOM), Department of Biochemistry and Department of Physics all from the College of Biological Sciences (CBPS) as well as those from the College of Agriculture and Veterinary Sciences (CAVS) and School of Pharmacy.

9. PROGRAMMES-CEBIB Masters Degrees MASTER OF SCIENCE IN BIOINFORMATICS MASTER OF SCIENCE IN BIOTECHNOLOGY PhD PHD (BIOINFORMATICS) PHD (BIOTECHNOLOGY

10. Kenyatta University • The existing BSc (Biochemistry) and BSc (Biotechnology) programmes have undergone review. The reviewed programmes take effect in the first semester of 2012/2013 Academic year • MSc and PhD in Biotechnology .

11. College of Agriculture and Veterinary Science • MSc In Biotechnology and Plant Breeding • All undergraduate and Master degrees do courses in Biotechnology

12. Moi University • A degree course in biotechnology and biosafety was launched at Moi University in Kenya School of Science, Department of Biological Sciences (DBS) on September 11, 2009. • The official launching ceremony was presided over by Moi University Chancellor Bethwell Ogot who said the first and foremost challenge facing Kenya and Africa in general is the fight to eradicate poverty and hunger.

13. JOMO JKUAT • MSc. Biotechnology • The duration of the Master of Science in Biotechnology shall be at least two academic years (18 months) and a maximum of 36 months from the date of registration.

14. RESEARCH APPLYING BIOTECHNOLOGY

15. Case-Research Program at KARI • Animal Health Research Programme • Animal Production Research Programme • Biotechnology Research Programme • Food Crops Research Programme • Horticulture and Industrial Crops Research Programme • Natural Resource Management • Range Research Programme • Regional Adaptive Research Programme • Seed Research Programme

16. Biotechnology and Africa (ABNE, 2012, absafrica.org)

17. CFT Experimentation in Kenya $UG ('Karembu, 2009)

18. Other African Countries-'Karembu 2009, ABNE 2011

19. Role of Kenya in the Regional

20. Lamu Port and Lamu-Southern Sudan-Ethiopia Transport Corridor • The Lamu Port and Lamu Southern Sudan-Ethiopia Transport Corridor (LAPSSET) aka The Lamu corridor is a transport and infrastructure project in Kenya that when complete will be the country's second transport corridor. • Kenya's other transport corridor is the Mombasa port and Mombasa - Uganda transport corridor that passes through Nairobi and much of the Northern Rift.

21. Kenya and Trade Hub for Eastern • Mombasa • Port of Lamu • Import- Export • Uganda, Ruanda, DRC, Burundi, Sudan • Food • Food Aid • Emerging Composition- Dar es salaam • Kigali-emerging airport

22. World Soybean www.soystats.com/2012/page_30.htm

23. Distribution of global corn production in 2011, by country 38.20%

24. Five countries (83%) World cotton-

25. World Bank Faults Kenya for Blocking Regional Trade • NAIROBI, Kenya, June 18 2012 – Kenya’s tough trade rules and regulations on imports from its regional counterparts are detrimental to the country’s trade growth, according to the latest World Bank Kenya Economic Update • The report highlighted Kenya – out of a select pool of African countries (Senegal, Madagascar, Mauritius, Namibia and Uganda) – as the only country that imposes more rules and regulations on imports from its regional partners than on imports from the rest of the world. • When poorly implemented, these rules and regulations end up acting as non-tariff barriers further constraining trade and subsequently raising domestic food prices. • With the price of rice and bread in Kenya 42 percent higher and the price of fresh fruit and vegetables 30 percent higher, opening to regional trade is necessary for Kenya to deal with its vulnerability to recurrent droughts. • Kampala — PRESIDENT Yoweri Museveni has asked the Kenyan government to be sensitive and avoid policies that impact negatively on the import trade to landlocked neighbours within the region.

26. IS THE BAN UNDERCUTTING OUR WON LAWS

27. OUR CORE FUNCTIONS-OF NBA • The Authority is mandated to • Consider and determine applications for approval for the development, transfer, handling and use of genetically modified organisms, and related activities in accordance with the provisions of the Biosafety Act; • Co-ordinate, monitor and assess activities relating to the safe development, transfer, handling and use of genetically modified organisms in order to ensure that such activities do not have adverse effect on human health and the environment; • Co-ordinate research and surveys in matters relating to the safe development, transfer, handling and use of genetically modified organisms, and to collect, collate and disseminate information about the findings of such research, investigation or survey;Identify national requirements for manpower development and capacity building in biosafety;

28. CORE FUNCTIONS-OF NBA • Identify national requirements for manpower development and capacity building in biosafety; • Advise the Government on legislative and other measures relating to the safe development, transfer, handling and use of genetically modified organisms; • Promote awareness and education among the general public in matters relating to biosafety; andEstablish and maintain a biosafety clearing house (BCH) to serve as a means through which information is made available to facilitate exchange of scientific,technical, environmental and legal information on, and experience with, living modified organisms; • Perform any other function which is incidental to the performance of any of the foregoing functions.

29. KENYA BIOSAFETY ACT 2009 • FIRST SCHEDULE (s.2) • REGULA TORY AGENCIES • 1. Department of Public Health. • 2. Department of Veterinary Service$. • 3. Kenya Bureau of Standards. • 4. Kenya Plant Health Inspectorate Services. • 5. Kenya Industrial Property Institute. • 6. Kenya Wildlife Service. • 7. Pest Control Products Board. • 8. National Environment Management Authority.

30. Has the Public Health Overstepped it mandate • In conducting its functions, The National Biosafety Authority works in close collaboration with the following regulatory agencies as specified in the Biosafety Act. These institutions are also regulators as provided by the law that established them: • 1. Department of Public Health: It safeguards the health of consumers through food safety and quality control, surveillance, prevention and control of food borne diseases/illness.

31. THE SERILINI STUDY IN CONTEXT AND THE GMO IMPORTATION BAN

32. Risk assessment process: From Koenig et al. Food and Chemical Toxicology 42:1047–1088, 2004.

33. Allergenicity and Toxicological Studies- • History of safe use • Bioinformatics • Digestibility • Simulated gastric Digestion • Simulated intestinal fluid (SIF) • Heat Stability • IGE • History of safe use • Bioformatics anal • Digestibility (GIF) • Simulated gastric Digestion • Simulated intestinal fluid (SIF) • Heat Stability • Animal Feeding

34. Observations on the Ban • Blanket Ban for all GMOs based on one event Nk603 • Many Countries where NK603 have been commercialized have not recognized the study • Many of these countries have not effected the ban

35. NK603 Toxicological study • The CP4 EPSPS gene encodes a single polypeptide of 455 amino acids (47.6 kDa) which exhibits about 50% amino acid sequence similarity with the analogous plant EPSPS enzyme. The family of bacterial and plant EPSPS proteins are not known to display any toxic or allergenic properties. The potential toxicity of the CP4 EPSPS protein was assessed by comparing its amino acid sequence against a database of 4,677 protein sequences (not all unique) that have been associated with toxicity, and in an acute oral toxicity study in mice. The CP4 EPSPS protein did not display any sequence homology with known protein toxins and did not result in any adverse effects on test animals (50 males, 50 females) receiving doses up to 400 mg/kg of bacterially derived CP4 EPSPS protein. The single amino acid substitution within the CP4 EPSPS L214P protein did not alter the sequence comparison results.

36. Composition, Expression an d Agronomic Studies • Composition-Analyses of grain samples included measurements of proximates (protein, fat, ash, moisture), acid detergent fibre (ADF), neutral detergent fibre (NDF), amino acids, fatty acids, vitamin E, minerals (calcium, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, and zinc), and the antinutritional components, phytic acid and trypsin inhibitor. • ExpressionExpression of full-length (approx. 47 kDa) CP4 EPSPS protein was confirmed by Western immunoblot analysis and protein concentrations were estimated using ELISA. Plant samples from line NK603 and the non-transformed parental control line were collected from six non-replicated and two replicated field sites during the 1998 growing season and assayed using a double antibody sandwich (DAS)-ELISA employing monoclonal anti-CP4 EPSPS antibody as the capture antibody and a horseradish peroxidase-conjugated anti-CP4 EPSPS polyclonal antibody as the detection reagent. Mean CP4 EPSPS protein levels (across all sites) were 25.6 ?/g (fwt; range 18.0 ? 31.2) and 10.9 ?/g (fwt; range 6.9 ? 15.6) for forage and grain tissue, respectively. • Agronomic Studies- compared to conventional

37. Animal Feeding Studies • Acute toxicity Studies (29 Days) • Repeated Dose studies (90) • Serilini Studies at 2 years-Albino rats, NK603, Glyphosate • Expressed Proteins in NK603

38. OECD Draft Guidance Document April 2010 1 OECD DRAFT GUIDANCE DOCUMENT N° 116 ON THE DESIGN AND CONDUCT OF CHRONIC TOXICITY AND CARCINOGENICITY STUDIES, SUPPORTING TG 451, 452, 453 TABLE OF CONTENTS

39. CODEX Principles and Guidelines • Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals CAC/GL 68-2008 [pdf 106kb] • Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. CAC/GL 44-200. (Adopted in 2003, amended in 2008) [pdf 33kb] • Principles for the risk analysis of foods derived from modern biotechnologypdf, 51kb • Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plantspdf, 86kb • Guideline for the conduct of food safety assessment of foods produced using recombinant-DNA microorganismspdf, 115kb

40. Principles of Food Safety Analysis-Codex(CAC/GL 44-2003 Risk Assessment • Substantial Equivalence • Case-by Case • Science based multidisciplinary data • Take into consideration accompanying Guidelines • Data should be assessed using appropriate science-based risk assessment methods • Procedures should be scientifically sound and parameters being measured comparable

41. Issues to Consider in the discussion • Are discouraging researchers, academicians, and students pursuing agricultural biotechnology discipline.  • Money and time invested by the government and the donor community on agricultural biotechnology may go to waste if this decision is not reversed. • Negative spill-over effect to the neighbouring countries and the region – Ban will have a negative impact on agri-biotech  in the region as Kenya is viewed as a leader in ST&I • Disregard of the law (Biosafety law) may lead to acts of lawlessness and vandalism of on-going CFTs • Demotivation of competent authorities and local experts • Wastage of taxpayers monies used to support public institutions conducting GM research work, teaching etc.

42. Issues to Consider in the discussion • Will not the taxpayers monies used to support public institutions conducting GM research work, teaching etc.??? • Food AID- and vulnerable Approximately, 2.2 million food-aid dependant Kenyans will be worst hit by the move since the corn-soy blend supplied may contain traces of genetically modified corn and/or soy. • Are efforts towards enhanced agricultural productivity using modern biotechnology to meet Kenya’s food security needs possibly will be derailed.  • Will there be negatively affect trade in GM foods.  For example, South Africa used to supply Kenya with white corn before the mandatory labelling requirement and GM foods concerns.  • Are we relenting on our international obligations - Codex, WTO obligation ?? • Are we contradicting the cornerstone of Vision 2030 – if Kenya cannot import other countries produce, how can it commercialise GM crops and make agric competitive to trade with others in the region and beyond?