1. How do we integrate issues and implement Biosafety Protocol? Professor Diran Makinde AfricaBio, South Africa

2. Purpose of meeting: Information sharing AfricaBio: who, what, when? Information on the role of biotech in Africa to top govt. officials & potential delegates to the next COP/MOP3. To improve effectiveness of countries to input positively and effectively on the Protocol. To enhance regional cooperation & info flow on Protocol implementation issues.

3. rDNA techniques Genetic modification Gene transfer Selection, breeding Chemical and radiation mutation Conventional Modern Tissue / cell culture Traditional Bread, Beer Wine, Vinegar Compost, Mining, Ethanol, etc. Low High Knowledge Sustainability Safety IndustryEnvironmentFood, Feed Fibre Medicine ProcessingProduction CropsAnimals ? Genomics Proteomics Metabolomics ? Molecular breeding Diagnostics Enzymes: Cellulase, protease, lipase Pectinase, glucanase, amylase, chymosin, etc Additives: Vitamins, amino acids, etc Biotechnology

4. Global GM crops area (total) Source: ISAAA 2003

5. Acceptance Issues related to GM Crops Food Safety: labeling and traceability Environmental Impact:- Gene Flow-conservation of biodiversity coexistence; Effect on non-target organisms Durability of Bt resistance Restricted Access and Control of GM technology- role of the private sector, IPR; Ethical considerations.

6. Reason for biotech regulation The impacts of GMOs needs to be evaluated The products of biotech are living genetically modified organisms (GMOs) As living entities, GMOs can spread and replicate once released into the environment An assessment of their impact on the environment is necessary= Biosafety.

7. Biotechnology Policy Successful agricultural biotech countries: - strong biotech policy & regulatory legislation 1st priority- National biotech policy ( regulatory, a supportive safety role rather than a restrictive role)

8. Cartagena Protocol on Biosafety Concepts:- (Bio)safety = policies, measures and procedures to minimise potential risk. - Precautionary approach = no need for decision based on inadequate information Scope:- Includes LMO’s for introduction into environment LMO-FFP’s (simplified procedure) LMO’s for contained use (except AIA) LMO’s in transit (except AIA) - Excludes LMO’s which are human pharmaceuticals Information sharing - BCH

9. Overview of the CPB The Protocol reflects the commitment of the international community to provide for safety in biotechnology RSA, acceded to it in Nov 2003 DEAT is the National Focal Point and DoA is the National Competent Authority

10. Main requirements of the Protocol The AIA Procedure Risk assessment and risk management LMOs for food, feed and processing Biosafety Clearing House Capacity building Liability and redress Socio-economic considerations

11. Art 27: Liability and Redress Key demand by developing countries in the biosafety negotiations was the creation of a system for liability and redress COP/MOP1 agreed terms of reference for an open-ended ad hoc working group of legal and technical experts on international rules and procedures by 2007

12. Key Issues for Debate The ability to define incidents of damage caused by GMOs and clearly to establish those that are legally responsible. The threat of comingling and adventitious presence of GMOs in commodity shipments, which might give rise to liability claims; and how Responsibility is to be allocated among the wide range of actors involved in int’al GM trade, including export/import bodies, farmers, seed/ biotech firms, commodity traders, and farmers

13. Open-ended Ad hoc Working Group 25-27 May 2005 Task: “to compile elements as a basis for future work” Elements for discussion are: Scenarios Scope; Damage; Channeling of liability Mechanisms of financial security Standing/right to bring claims Limitation of liability

14. Elements of the discussion (Contd) Non-parties Choice of instruments Additional section on capacity building

15. Assessment in national context of Article 27 for implementation Because there is no comprehensive liability regime for GMOs we need to address the problem with reference to existing national, regional and inter’al liability legislation Determine whether existing legislation adequately addresses LMO damage

16. Article 26:Socio-economic considerations Modern biotech benefits: Improved crop (more nutritious); Higher yielding; Resistant to pests & diseases; Tolerant to physical stresses (saline soils & drought); & More environmentally sustainable (FAO, 2004)

17. Socio-economic considerations II Costs: Environmental; Human/animal health; Socio-economic. Therefore decisions to ensure maximal benefits while minimising its potential costs

18. Article 26 The Protocol appears to limit the scope that govt. may consider in regulatory decisions to circumstances as the impact of the import of LMOs on indigenous or local communities, cultural traditions,etc Paragraph 2 encourages Parties to cooperate on research and info exchange on any socio-economic impacts of LMOs (indigenous/local communities)

19. Relevance Relevant to domestic biosafety decisions e.g. identification of socio- economic issues to inform national research priorities or product development. Others like IPR or consumer-related be addressed by laws that are specific to these issues rather than biotech e.g. patent laws & consumer right laws

20. Green revolution experience Advanced breeding tech; chemical inputs; & mechanization Unintended consequences: -environmental & health problems due to increase use of chemicals; -ve socio-economic impacts b/c high- yielding varieties required, higher degree of mechanization, & job losses especially by women.

21. World status (CBP at 18 Feb. 2005) Africa: Algeria, Botswana, Burkina Faso, Cameroon, Djibouti, Egypt, Ethiopia, Gambia, Ghana, Kenya, Lesotho, Liberia, Madagascar, Mali, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Seychelles, South Africa, Togo, Tunisia, Uganda, United Republic of Tanzania, Zambia (28 Countries) Asia & Pacific: Bangladesh, Bhutan, Cambodia, Cyprus, Democratic People's Republic of Korea, Fiji, India, Indonesia, Iran (Islamic Republic of), Japan, Jordan, Kiribati, Lao People's Democratic Republic, Malaysia, Maldives, Marshall Islands, Mongolia, Nauru, Niue, Oman, Palau, Samoa, Solomon Islands, Sri Lanka, Syrian Arab Republic, Tajikistan, Tonga, Viet Nam (28 Countries) Europe: Albania, Armenia, Belarus, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Republic of Moldova, Romania, Slovakia, Slovenia, Ukraine, Austria, Belgium, Denmark, European Community, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland (35); Latin America & Caribbean (GRULAC): Antigua and Barbuda, Bahamas, Barbados, Belize, Bolivia, Brazil, Colombia, Cuba, Dominica, Ecuador, El Salvador, Grenada, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, Saint Kitts and Nevis, Saint Vincent and the Grenadines, Trinidad and Tobago, Venezuela (22 Countries)

22. Africa – signed CPB

23. Africa ratified (at 18 Feb. 2005)

24. Africa - no formal activity (Sept03)

25. 8/05/01Monsanto Company Confidential Agenda None Guideline Enforced Status: January 2004 Overview of biosafety regulation in Africa Pilot studies Mauritania, Morocco, Tunisia UNEP/ GEF projects Senegal, Mali, Guinea-Conakry, Siera Leone, Mali, Togo, Benin, Niger, Algeria, Congo, Botswana, Rwanda, Ethiopia, Tanzania, Mozambique, Madagascar Mauritius

26. 8/05/01Monsanto Company Confidential Agenda None Trials Commercial Status: January 2004 Biotech commercial ’98 RSA (Bt cotton) ’99 RSA (Bt corn) ’01 RSA (RR Cotton, RR soy) ’03 RSA (RR corn) Biotech in trial ’00 Egypt (Bt cotton) ’01 Zimbabwe (Bt corn) ’02 Kenya (Virus res. S. potato) ’02 Egypt (Bt corn) ’03 Burkina Faso (Bt cotton) Overview of biotech crop planting - Africa

27. Access to UNEP/GEF funding in Africa - July’04 Implementation: Namibia, Kenya, Uganda Development: (Red = SADC)

28. South Africa as a role model

29. The GMO Act 15/1997 & its Regulation How the legislation function Scope of biosafety assessments and reviews Prescribed biosafety actions and monitoring

30. Types of permit To register a facility for activities involving GM Authorization to import or export GMOs/ LMOs from/to RSA Contained use of GMOs Conduct trial release General release of GMOs Commodity clearance Import and re-export of consignments in transit- raw, processed products approved or not approved in RSA.

31. Safety checks

33. Bt-cotton vs. non Bt-cotton (both planted at the same time)

34. Other Crops being improved by this tool Maize-resistant to stem borers; nutrient-enriched(QPM+Zn, Fe& VitA) fungal toxin reduction in peanuts and maize; cowpea(insect &storage pests); GM cassava-res to CMV) drought and acid soil tolerance crops; Others- banana, rice, sweet potato, millet, sorghum,yams,etc.

35. Constraints in developing Regulatory Framework Limited institutional capacity- human, financial & institutional Lack of domestic regulatory policy for testing, release and commercialisatn The complexity of the decisions required within a specific time-frame The problems of public involvement in countries with high levels of illiteracy.

36. Addressing the Constraints Regional approach- SADC, ASARECA, CORAF/WECARD NEPAD/FARA AFRICAN MODEL LAW UNEP-GEF USAID (Program for Biosafety System)

37. Food crisis in Sub-Saharan Africa Note: Nonfood uses such as feed, seed, and waste have not been subtracted here. Consumption projections are based on a nutritional target of 2,100 calories per capita per day. 3/21/01

38. Way Forward for Africa Build on existing legislation/Acts; HARMONIZATION- govts depts, regionally and internationally; Share information and resources at regional level; Regulations are not to be barriers (Caution and not precaution);

39. Thank you! For additional information contact: AfricaBio Tel: +2712 667 8697 Fax:+27 12 667 1920 Email: africabio@mweb.co.za www.africabio.com