It is generally accepted that biotechnology both traditional and modern could contribute substantially to sustainable development by improvements in the fields of agriculture, food and feed production and supply, industry, health care (human and animal) and environmental protection. Traditional biotechnology has been in use for centuries notably in the brewing and fermentation industries and in the production of animal vaccines. Modern biotechnology, however, includes, among other technologies, cell and tissue culture, monoclonal antibodies, and recombinant DNA (rDNA) or “genetic engineering” techniques. The increased precision and shorter time required in producing results with modern biotechnology make these new techniques particularly attractive.

The development of new techniques of genetic modification in the early 1970’s introduced a new dimension to biotechnology. Scientists can now recombine DNA from different organisms, giving rise to Living Modified Organisms (LMOs)/Genetically Modified Organisms (GMOs). Recombinant DNA (rDNA) organisms are derived by introducing a section of DNA from a “donor” organism to a “recipient” organism. The genome of the recipient organism is, therefore, modified. While recognising the potential benefits of this new molecular technique which allows a greater diversity of genes to be introduced into organisms, the relative lack of familiarity with such modified organisms and the gaps in knowledge as regards the effect of the interaction of these LMOs with the environment, make it necessary to institute measures to ensure that the technology is developed in a precautionary and judicious manner. The results of this modification need to be assessed for risks to human health, conservation of biodiversity and the environment before the intentional release of the modified organism.

In recognition of the tremendous benefits of modern biotechnology and the risks inherent thereto, the guidelines contained in this document seek to provide appropriate regulatory measures to assist all stakeholders in the establishment and maintenance of national and institutional capacities to provide for safety in biotechnology, development of expert human resources and efficient exchange of information.