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.
Status of biotechnology in Eastern and Central Africa
This work examines trends of both conventional and modern biotechnologies in selected Eastern and Central African countries namely Kenya, Uganda, Tanzania, Ethiopia, Rwanda, Burundi and Democratic Republic of Congo, with the aim of giving an up-to-date assessment of their national policies, institutional capacities, and the activities being carried out. Agricultural biotechnology seems to take the lead while biotechnologies related to health, industries and environment are lagging behind. Kenya leads the region with its biotechnology policy framework in place and more on-going biotechnology related activities, followed by Uganda. Tanzania has already developed its biotechnology policy but is slower to translate it into practice especially on matters related to modern biotechnology. The rest of the countries are yet to formulate their biotechnology policies but efforts are underway to achieve that goal. Plant tissue culture is done in all the countries and some projects have already been commercialised. Transgenic crops/animals projects are mainly at the field trial stage and none has been commercialised. The main constraints facing the biotechnology industry in the region are poorly skilled human resources, lack of modern facilities, poor public perception and weak political will by some governments. More vigorous practical actions are needed in order for biotechnology to benefit the people of this region in terms of food security, economic growth, improved health and environmental protection. 
 
   
 
 Key words: Biotechnology, genetically modified organisms, molecular assisted selection, tissue culture.
Enabling the safe use of biotechnology : principles and practice
This publication describes the enabling environment required in developing countries to acquire powerful new tools in biotechnology and to assess their potential usefulness. It is designed to provide a practical guide for policymakers and research managers who are responsible for: (i) making decisions on ensuring the safe use of modern biotechnology in producing new products in medicine, agriculture, and the environment, and (ii) promoting environmentally sustainable development. This document reviews the current trends in biotechnology and identifies areas in which new developments are likely to contribute to environmentally sustainable development. It outlines the enabling environment, including the national regulatory framework, necessary to ensure safe use of biotechnology without endangering public health or the environment. It describes risk assessment procedures to identify possible risks in research and development, and illustrates risk management procedures and possible models for the contained experimental use and planned introduction of organisms with novel traits and other products. This publication also summarizes the international context in which national biosafety systems are developed.