This paper was prepared by Julian Kinderlerer as a background document for the United Nations Environment Programme (UNEP) – Global Environment Facility (GEF) Project on the development of national biosafety frameworks. It discusses the key issues involved in the regulation of biotechnology at the international level, and in particular the requirements of the Cartagena Protocol on Biosafety, which lays down rules governing national-level regulations for the international movement of genetically modified organisms.

The paper discusses the background to biotechnology regulation in Agenda 21, the Convention on Biological Diversity and the Biosafety Protocol; developments in biotechnology in different parts of the world, including differences in regulatory approaches between different countries; the need for science-based decision making; and key concepts such as risk assessment and risk management.

The paper concludes with a list of the administrative systems and steps that the Biosafety Protocol requires countries to put in place for their national biosafety regulatory frameworks. The UNEP–GEF project has now moved ahead to the implementation phase, but this document remains a useful reference for key concepts and basic requirements in biosafety risk assessment and regulation.

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