Biosafety, Challenges and National Biosafety Frame work in Zambia
Biosafety, Challenges and National Biosafety Frame work in Zambia By Dorothy Kangwa Mulenga, PhD Chief Science & Technology Officer Paper presented at the Hunger, Food Aid and GMOs Conference held in Maputo, Mozambique 15-16 July 2004 Department of Science and Technology Ministry of Science, Technology and Vocational Training P.O Box 50464 LUSAKA Tel: 260 1 252073 Fax: 260 1 252089 Email: [email protected] 1. INTRODUCTION The 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 (e.g. biological diversity), human health, animal welfare, the live hoods of small-holder farmers in developing countries, 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. To address these concerns, the issue of “biosafety” has emerged as being the most critical to the deployment of modern agricultural biotechnology in both the developing and industrialised countries. 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. The term biosafety therefore 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, there are similar pressures on them to ensure that any import and transfer of the technology does not pose unacceptable risks. Confronted with this challenge, developing countries realised the need for an international agreement that mandates biosafety in the transboundary movement of GMOs. This move was strongly resisted for five years by the main GMO-exporting countries. But the collective and sustained effort by developing countries forced the exporting countries to stay at the negotiating table. The outcome was the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD). It was adopted in January 2000 in Montreal at an extraordinary meeting of the Conference of the Parties (CoP) to the CBD. About 130 countries participated in the meeting. The Protocol on Biosafety came into force in September 2003. So far a 100 countries have ratified it. 1.1 Cartagena Protocol on Biosafety The protocol establishes international procedures for managing transboundary movements of GMOs. The protocol also attempts to 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). A strict system should apply to 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). Now that the Cartagena Protocol on biosafety has come into force, the task now is to implement it. So far only a few developing countries have made any headway in building up institutions capacitates and instruments required for implementation. 2. 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. In this sense much contemporary regulation provides regulation for business rather than regulation of business. The following are the challenges in the regulation of GE/GMOs: 1. Biotechnology is applied in all sectors in society – how to regulate in all. A Country needs to look at all relevant laws and make necessary amendments and updates. 2. Globalization /National Sovereignty – we want but not the side effect of it 3. 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; ∑ Lack of formulated biotechnology and biosafety policies – most of the countries in the Africa formulated their policies recently; ∑ 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); ∑ 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. ∑ 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; ∑ Need for funding of safety issues as integral part of research and development projects; and ∑ Need for national and regional collaboration 3. 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. Although biosafety frameworks vary from country to country, their 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; ∑ A decision-making system that includes risk assessment and management for the release of GMOs; ∑ Mechanisms for public participation and information 3.1 Institution structure The Ministry of Environment and Natural Resources is the Focal Point for the CBD while the National Institute for Scientific and Industrial Research is the National Biosafety Focal Point. 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. The Policy attempts to strike a prudent balance between protection and promotion of some of the benefits of biotechnology. As a result of adoption of the Policy, the Ministry of Science Technology and Vocational Training, the lead Ministry in these issues is now embarking on stakeholder sensitization and consultations on the Biosafety legislation. This process will lead to submission of a finalised draft Biosafety Bill to the Ministry of Justice for final drafting and submission to Parliament. The drafting team, which has been constituted, has the following representatives; Agricultural Research Officer, Environment & Natural Resources Management Officer, civil society, Lawyer, Cartagena Protocol Expert and Biotechnology and Biosafety Focal Person in Ministry of Science and Technology. This team is responsible to plan for the stakeholder consultation capture submissions and finalise the draft to be submitted to the Ministry of Justice. It is envisaged that the bill will be enacted by end of December 2004. The process that will follow after enactment of legislation will involve drafting of regulations and guidelines. All this will be in consultation of stakeholders In drafting legislation it is very important to take into consideration impacts of GM crops in countries such as Argentina who commercialised GM crops and have been growing these for some time. Emerging reports in this country are that they have found evidence of agro toxics intoxication in peasants as well as their crops and animals as a result of aero spraying of herbicides on RR Soya. 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 is important. 3.2 Strategic Plan on Biotechnology and Biosafety In order to facilitate the implementation of the policy, Government has developed a five year Strategic Plan (2003 – 2007) on Biotechnology and Biosafety. The Biotechnology and Biosafety 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. 3.2.1 Core Strategic Programmes The Plan has identified seven (7) programmes for the effective and efficient implementation of the Biotechnology and Biosafety Framework. These include: i. Human Resource and Infrastructure: This aims at developing adequate infrastructure, expertise and skills and training on appropriate human resource base. ii. Environment and Biodiversity: This aims at conserving the genetic diversity of Zambia’s crops, livestock, fish and controlling environmental pollution. iii. Legal Framework: This aims at enacting legislation to govern the research, development and utilisation of Genetically Modified Organisms (GMOs). iv. Research and Development: This aims at increasing crop and livestock production and productivity; increasing production and quality of industrial biotechnology products; protecting the population against preventable diseases; and developing capacity to diagnose TB, HIV and malaria. v. Commercialisation: This aims at ensuring that products of biotechnology are produced and marketed by industry. vi. Regulatory Mechanism: This aims at setting up an appropriate regulatory framework. vii. Public Participation: This aims at increasing public awareness and understanding of all aspects of biotechnology and biosafety and fostering public participation in biotechnology and biosafety regulatory process. The plan focuses on the main issues that the policy seeks to address. To this effect, a project proposal for Biosafety capacity building was developed. Zambia is receiving is both financial and technical support from the Norwegian government. The support is for two year (2004-2005). 3.3 Ratification of the Cartagena Protocol on Biosafety 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. 4. CONCLUSION that is Policy –makers, decision-makers, traditional leaders, consumers, civil society, farmers, seed companies, researchers, industry and academicians; 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. 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. BIBLIOGRAPHY Benbrook Charles A study of environment impacts of GMOs. International Centre for Trade and Sustainable Development. At www.biotech-info.net/first-generation-GMC.pdf Biotechnology and Development Monitor: Public Perceptions No. 47 September 2001 Amsterdam, The Netherlands. Convention on Biological Diversity (CBD), 2000. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Text and Annexes. Secretariat of the CBD, Montreal, Canada. Fig David 2003. The decision of the Zambian government to ban genetically modified food aid. Paper presented to the workshop of research Committee 44 “Environment and Society” of the International Sociological Association Meeting, Third World Social Forum, Porto Alegre, 23-28 January 2003 GRZ 2003, National Biotechnology and Biosafety Strategic Plan. Ministry of Science, Technology and Vocational Training. Lusaka, Zambia. UNEP 2002. UNEP/GEF building capacity for the implementation of the Cartagena Protocol on Biosafety.