Introduction

The purpose of this publication is to provide a practical guide for policymakers and research managers who are responsible for making decisions on ensuring the safe use of modern biotechnology; producing new products in medicine, agriculture, and the environment; and promoting environmentally sustainable development.

This publication continues from the 1990 study Agricultural Biotechnology: Opportunities for International Development, sponsored by the World Bank, the International Service for National Agricultural Research (ISNAR), and the Australian government. In 1992 ISNAR and the World Bank published the study Biosafety: The Safe Application of Biotechnology in Agriculture and the Environment as a brief for policymakers prior to the United Nations Conference on the Environment and Development (UNCED). The study summarized the development of modern biotechnology, reviewed the accumulating documentation on the safe use of biotechnology in agriculture and the environment, and suggested a series of steps required to establish a national biosafety system. Biosafety is a term used to describe the policies and procedures necessary to ensure the safe application of modern biotechnology.

Since 1992 the World Bank has worked with a number of countries to assist in the formulation of national biosafety practices as part of the enabling environment necessary to underpin their investments in biotechnology. This document reports on the steps required to establish a national regulatory framework for biotechnology that will enable safe use of new products emerging in the fields of agriculture, the environment, and human health, especially in developing countries. It also reviews material accumulating on the introduction and commercial use of new biotechnology products. It describes how the regulatory requirements in these countries are being modified in light of increasing familiarity with the products and processes of modern biotechnology. The publication also summarizes the international context in which national biosafety systems are developed.

Chapter 1 reviews the current trends in biotechnology and identifies the areas in which new developments in modern biology are likely to contribute to environmentally sustainable development.

Chapter 2 outlines the enabling environment, including the national regulatory framework necessary to ensure safe use of biotechnology without endangering public health or the environment.

Chapter 3 describes risk assessment procedures to identify possible risks in research and development involving organisms with novel traits, plants, and animals.

Chapter 4 illustrates risk management procedures for the contained use and planned introductions of organisms with novel traits and other products of biotechnology.

Chapters 5, 6, and 7 present possible models for planned introductions, contained experimental use, and small-scale introduction and large-scale use of novel organisms, drawn from the experience gained by the Genetic Manipulation Advisory Committee.

Consideration is being given to making this publication available in electronic media to facilitate ease of access and use. It is also intended that a decision support system for biosafety will be developed from this document and other relevant data in the future.