Abstract

One of the highest accolades a scientist can achieve is to have a paper selected by the Science Citation Index of the Philadelphia Library as the most cited paper of the year. There can be no doubt that the Recombinant DNA Safety Considerations, published by the OECD in 1986, and known as the Blue Book after the color of the cover, is the resource document most frequently cited at the international level by the various stakeholders of society. I myself, who witnessed and participated in the revolution of molecular biological science and its regulation, have been frequently confronted with this fact: whenever people talk about the introduction of this new technology, the Blue Book is always referred to as the most valuable reference work. Early on, soon after the two European directives on the contained use of genetically modified organisms and on their deliberate release into the environment were issued (EC 219, EC 220), a steering committee was established for the conservation and management of the environment and natural habitats, in order to study and advise on the potential ecological impact of genetically modified organisms. This committee continued to function until the organization of a Pan-European Conference on the potential long-term ecological impacts of the dissemination of GMOs, all the documents and activities of which used the Blue Book as a major source. As both the developed and the developing world realized the value of biotechnology, regulatory activities were also begun in the US (NIH guidelines) and in other countries, all using this publication as their knowledge base. The conveners of the United Nations Conference on Environment and Development (UNCED) also included biotechnology in its agenda in the document entitled Agenda 21, and devoted a whole chapter to biotechnology (Chapter 16). This chapter and the UNEP International Technical Guidelines for Safety in Biotechnology (printed in all six official languages of the UN) reflect the spirit of the Blue Book. If a comparison is made of the efforts made by individual countries to establish national regulatory frameworks for gene technology, the footprint of the Blue Book is clearly perceptible in each case. Until the year 2000, almost all the industrialized or rapidly

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