Review of the Policy, Regulatory Mechanisms and Administration of Biosafety in Eastern and Southern Africa: A study of Kenya, South Africa, Malawi and the ASARECA initiative

This report summarises the results of a review of the policy, regulatory mechanisms and administration of biosafety in Kenya, Malawi and South Africa and under the ASARECA regional initiative. The report focuses on the current situation and provides insights as to the form that developments in the area of regulation of biotechnology are likely to take. The first section is an introduction, which provides the definition and scope of biotechnology as used in this report. It provides a brief status of agricultural research; the areas of research and the actors involved in biotechnology in the study countries. With the exception of South Africa, experimentation in transgenic crops is still under development. Most of the current agricultural biotechnology R&D activities focus on improving crop productivity. The actors are mainly National Agriculture Research Institutes, International Agricultural Research Centres and universities. Private sector involvement is in the form of multinational companies. The second section discusses the frameworks for the regulation of biotechnology. These include international obligations, regional attempts, as well as national efforts in regulating biotechnology in the study countries. Regulation at the national level has been in the form of national policies, national strategies and through legislation. In Kenya and in most countries under the ASARECA initiative, acts of parliament are yet to be enacted. The proposed bill and regulations in Kenya and the proposed regional regulatory structure under ASARECA are discussed with the aim of providing an insight as to the trend regulation in these jurisdictions is likely to take. The third section is a discussion on institutional arrangements in the field of agricultural biotechnology. Who are the institutional actors? What are the synergies? What is the institutional capacity in terms of human resources and physical infrastructure? This section also explores the commercialisation and innovation attempts in the study countries. It examines public perception and acceptance of modern biotechnology and ends with a brief mention on intellectual property protection in the study countries. South Africa has a developed institutional structure with impressive facilities and adequate human resource capacity. Critical mass in modern biotechnology in the other study countries is yet to be attained. Facilities for experimentation in GM technology are likewise lacking in Kenya, Malawi and other ASARECA countries. The fourth section summarises the review and presents the way forward. South Africa is best placed to handle applications for testing transgenics such as the rosette-resistant groundnut developed by ICRISAT. A representative from the Malawi biosafety committee should be involved in the testing of the groundnuts in RSA as part of a capacity building exercise and also to pave the way for the testing of the groundnuts in Malawi. In Kenya, there are indications that once an event is approved elsewhere, it is likely to receive timely approval subject to any additional testing that the National Biosafety Board may deem necessary. ICRISAT would have to collaborate with the KARI Institutional Biosafety Committee through which the application to the National Biosafety Committee would be made.