In a number of countries, concerns over the possible environmental and health implications of modern biotechnology have stimulated regulatory mechanisms for food safety and environmental risk assessment. Over the past two decades, such national biosafety frameworks, guidelines, and regulatory systems have often been implemented in a 'piecemeal' way, in response to the demands or urgent needs of the moment. Ideally, a biosafety system would be developed from a comprehensive plan. However, building such a system and making it operational is complicated by the fact that there is no single best approach nor standard that reflects national environmental, cultural, political, financial, and scientific heterogeneity.

Given these challenges and difficulties inherent in building regulatory systems and associated capacity, the International Service for National Agricultural Research (ISNAR) convened an expert consultation in July 2001. The purpose of this meeting was to develop a conceptual framework to address regulatory implementation and capacity-building needs of developing countries and Parties to the Protocol.

A framework for implementing national biosafety systems emerged, which consists of the following five elements:

  • national policies, strategies, and research agendas regarding biosafety;
  • national inventory and evaluation;
  • the knowledge, skills, and capacity base to develop and implement a biosafety system;
  • development of regulations; and
  • implementation of regulations.

This conceptual framework clarifies critical decision points in the development of a national biosafety system, systematically examines choices among policy options, and delineates some of the scientific and social dimensions of these options. It complements ongoing regional and global projects that facilitate the development of national biosafety guidelines and frameworks.