Abstract

BIOISAFETY AND REGULATORY PLATFORM IN SOUTH AFRICA

PlantBio, the National Innovation Centre for Plant Biotechnology, established under the National Biotechnology Strategy, is proposing to support the establishment of a Biosafety and Regulatory Platform.

In 2003, the Department of Science and Technology commissioned an audit of the biotechnology activities in South Africa. It was reported that although the South African industry is relatively small on a global scale, there is a wide range of products in the pipeline covering several sectors. Within the 13% activities recorded as support services, only two companies provided services in biosafety.

PlantBio manages a wide range of portfolios and guides research, development and commercialization in plant biotechnology. Its mandate is in the application and use of a range of technologies, including traditional plant breeding, tissue culture propagation, marker assisted breeding and genetic modification for the improvement of crops (e.g. cassava, maize, sorghum) important for the food security of the poor in South Africa, the sub-region and the rest of Africa.

Because the manipulation of genes has the potential to present unexpected phenomena with potential consequences for human health and the environment, biosafety should be a key component of biotechnology activities. In other words, biosafety, food safety and regulatory capacity and resources should keep abreast with developments in biotechnology.

Scientists in public institutions and small start-up companies lack the resources to manage regulatory submissions; in particular they have no knowledge of biosafety laws and information requirements under those laws.

It is for these reasons that PlantBio would like to support the establishment of a Biosafety and Regulatory Platform in South Africa, to develop the expertise to design risk assessments in order to ensure food and environmental safety of the products of modern biotechnology. Moreover, the Platform would ensure the development of knowledge to manage regulatory submissions.