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Biosafety, Challenges and National Biosafety Framework in Zambia

Biosafety, Challenges and National Biosafety Framework in Zambia Dorothy Kangwa Mulenga, PhD Chief Science & Technology Officer, Ministry of Science, Technology & Vocational Training Presentation Introduction Challenges of of GE/GMOs regulation National biosafety Framework in Zambia Conclusion INTRODUCTION (1) Concerns about the actual and potential effects of the “ Biotechnology revolution” has given rise to a number of controversial issues of a profound nature: - impact on the physical environment (biological diversity), - impact on human & animal health, - impact on the live hoods of small-holder farmers in developing countries, INTRODUCTION (2) Concerns: - the economic and social impact of genetically modified crops on developing countries, - the ownership and control of and access to genetic resources, and intellectual property rights. INTRODUCTION (3) To address these concerns, the issue of “biosafety” has emerged as being the most critical to the deployment of modern agricultural biotechnology There is however, a universal recognition and acknowledgement that for nations to benefit from the promise of biotechnology, its research, development, application and commercialisation must be done in a manner that minimises or avoids adverse effects to human and animal health as well as to the environment INTRODUCTION (4) Biosafety - describes a set of measures used for assessing; monitoring, and managing risks associated with GMOs and the policies and procedures adapted to that end. Governments of developing countries have been under growing internal and external pressures to permit the import of GMOs and transfer of GM-technology on one hand and on the other, to ensure that any import and transfer of the technology does not pose unacceptable risks. INTRODUCTION (5) Confronted with this challenge, developing countries realised the need for an international agreement that mandates biosafety in the transboundary movement of GMOs. Cartagena Protocol on Biosafety - establishes international procedures for managing transboundary movements of GMOs. - ensure that transit, handling and use of GMOs do not impact negatively on the conservation and sustainable use of biological diversity, nor create risks to human health (Art.4) INTRODUCTION (6) Cartagena Protocol: Took 5years to negotiate The Protocol on Biosafety came into force in September 2003. So far a 100 countries have ratified it. INTRODUCTION (7) Cartagena Protocol: - Advance informed agreement between exporting countries (Arts5-10). Risk management procedures should be institutionalised (Arts16-17, annex III). This means that clearing houses, national authorities and national focal points need to be created (Arts 19-20). Provision must be made for national capacity building, the creation of public awareness and public participation in decision-making (Arts 22-23) THE CHALLENGES OF GE/GMO REGULATION Biotechnology regulations have responded more to commercial and trade concerns than to public anxiety about environmental and social risks. Challenges: - Biotechnology is applied in all sectors in society – how to regulate in all. - Globalization /National Sovereignty – we want but not the side effect of it THE CHALLENGES OF GE/GMO REGULATION (2) In establishing functioning organisation structures and human capacity to ensure adequate policy implementation, the following are specific problems that need to be addressed: - Insufficient capacity for enforcement of guidelines and /or regulations; - Need for training at all levels to address shortage of human resources; THE CHALLENGES OF GE/GMO REGULATION (3) - Lack of formulated biotechnology and biosafety policies; - Formulation and implementation of guidelines and or regulations at various levels e.g. at research, contained use, field trials and commercial levels; - Need for information collection and exchange (e.g access to databases and knowledge of global developments); THE CHALLENGES OF GE/GMO REGULATION (4) - Need for risk assessment research focusing on specific African circumstances; - Need for more facilities and equipment to carry out proper monitoring and risk assessment research - How to handle the unknown/uncertainty – risk assessment: there has been no test done to establish the effect on human feeding on GM food and foodstuffs; No long term tests being conducted and there is less funding for scientific community working to better understand the implications of genetic engineering. THE CHALLENGES OF GE/GMO REGULATION (5) - Establishment of biosafety committees at institutional, national and regional levels and independent advisory boards – how to choose those people with the right kind of mind? - Planning and adaptation of methods to monitor effects of field tests and ensure compliance with regulations; THE CHALLENGES OF GE/GMO REGULATION (5) - Need for funding of safety issues as integral part of research and development projects; and - Need for national and regional collaboration NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA A national biosafety framework is a system of legal, technical and administrative mechanisms set in place to address safety in the field of modern biotechnology. Main elements are: A regulatory system set in place to address safety in the field of modern biotechnology; An administrative system to handle requests for permits for certain activities, such as releases of GMOs; NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA (2) A decision-making system that includes risk assessment and management for the release of GMOs; Mechanisms for public participation and information Institution structure: Ministry of Environment – Focal Point for CBD NISIR – National Biosafety Focal point NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA (3) The Ministry of Science, Technology and Vocational Training is responsible in co-ordinating the Government process of establishing the National Biosafety Framework. In order to move towards having a NBF in Zambia the government adopted the Biotechnology and Biosafety Policy in August 2003. NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA (4) The Policy attempts to strike a prudent balance between protection and promotion of some of the benefits of biotechnology. now embarking on stakeholder sensitization and consultations on the Biosafety legislation. Apart from environmental risk assessment and health risk assessment to both humans and animals, the socio- economic assessment and evaluation of the consequence of introduction of GE technology (i.e. culture effects, effects on farming culture, where trials will be conducted) and impact on other farming systems (such as Organic farming and rural livelihoods will be taken into account. NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA (5) In order to facilitate the implementation of the policy, Government has developed a five year Strategic Plan (2003 – 2007) on Biotechnology and Biosafety. The Strategic Plan identifies critical areas in biotechnology and the required corresponding investment that will enhance the implementation of the National Biotechnology and Biosafety Policy This Strategic Plan, therefore, provides the necessary guidance and modalities for the implementation of the Biotechnology and Biosafety Framework. NATIONAL BIOSAFETY FRAMEWORK (NBF) IN ZAMBIA (6) Zambia ratified the Cartagena Protocol on biosafety in March 2004 and will come into force on 25th July 2004. In the absence of a decision making process in Zambia and lack of capacity to detect GMOs in Food and Foodstuff, the Zambian Government is using accepted international norms the Precautionary Principle, Advance Informed Agreement, Risk assessment to maintained it’s position of not accepting GM foods. CONCLUSION There is need for a holistic approach to the issues of GM crops in Zambia. All concerned should be involved, In the drafting of the biosafety bill, stakeholder consultations is very important for all to own the process of regulating modern biotechnology. On assessment of modern biotechnology, the scope has to be expanded beyond the narrow technical concerns to a range of strategic economic, socio-cultural, political, ethical and moral issues associated with choices about new technologies. CONCLUSION Zambia needs to build capacity in both human resource and infrastructure at institutional level. This will enable Zambian experts to undertake research in biotechnology as well as address biosafety issues that are related to the products of biotechnology such as GMOs. There is need also to create awareness in biotechnology and biosafety of all stakeholders including the general public on a continuous basis. Thank You