Biosafety worldwide - Historical background

OECD activities

In 1982, the OECD published a first report dedicated to biotechnology (Bull, Holt and Lilly. Biotechnology: International trends and perspectives, ISBN 92-64-22362-2). It was the first intergovernmental document on the topic that took into account the environmental safety of GMOs and placed emphasis on the necessity of developing safety measures relating to new biotechnologies. Following recommendations from this report, in 1986 the OECD published a new report entitled: "Recombinant DNA Safety Considerations​", later known as the "Blue Book". This work was carried out by an ad hoc group of governmental experts on biotechnology safety and regulations. Among the representatives of the Belgian delegation in this ad hoc group was an expert from Sciensano (known at the time as the "Institute of Hygiene and Epidemiology").

​The OECD "Blue Book"

The recommendations from the OECD were mainly aimed at securing the commercial development of recombinant DNA techniques while ensuring the safety of the environment and human health. They pushed for the harmonisation of guidelines adopted by the Member Countries of the OECD by encouraging sharing of information on risk assessment and management linked to GMOs (the exact term used in the "Blue Book" was "recombinant DNA organisms"). The aim of the OECD was that the national regulations did not hinder technical progress in the field of recombinant DNA and ensured the protection of intellectual property and industrial secrecy. The importance of clearly informing the general public about the different aspects of biotechnology was also highlighted.
Recommendations from the "Blue Book" were firstly about large-scale industrial applications of recombinant DNA techniques and secondly about agricultural and environmental applications. More particularly in this domain, the OECD considered setting up general guidelines at an international level was premature. Nevertheless, the "Blue Book" insisted on the necessity of carrying out an assessment of potential risks prior to using GMOs in the environment. It also introduced two ideas that are still well present today within the methodology of GMO risk assessment: firstly, the fact that risk assessment should be done on a case-by-case basis; secondly, that the development of GMOs and their assessment should be done in in a stepwise fashion, moving, where appropriate, from the laboratory to the growth chamber and greenhouse, to limited field testing and finally, to large-scale field testing.​​​

​The contents of this "Blue Book" was partly based on experience acquired in certain Member Countries of the OECD in terms of the use of GMOs. At the time when the "Blue Book" was published, real applications such as genetically modified bacteria producing insulin (for the treatment of diabetes) or the human growth hormone were, in fact, already approved for marketing. At the same time, genetically modified plants and the debate on their potential effects on the environment entered into the political arena. It is worth remembering that the first field trial was carried out in Belgium in 1986. The first marketing authorisation for a GM food was granted in 1992 in the United States (the transgenic tomato Flvr Svr).

Like the guidelines from the NIH on the use of GMOs in the laboratory, the recommendations from the OECD "Blue Book" serve as a reference, at an international level, for the risk assessment of GMOs released into the environment. This work was supplemented in the years that followed by other reports aimed at taking into account new developments in the use of GMOs in industry, in the environment and in food (Safety Considerations for Biotechnology, OECD, 1992Safety considerations relating to biotechnology: Scale-up of crop plants, OECD, 1993Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and principles, OECD, 1993).

At that time, in industrialised countries, the safety of modern biotechnology products was covered by a vast array of general legislative provisions in the fields of health, safety or even environmental protection. In addition to these various legal provisions, certain countries also had guidelines or recommendations dealing, more specifically, with the applications of recombinant DNA. The general tendency in developed countries was clearly to favour self-assessment and not to implement strict regulatory measures that could hinder technological development in this area. In its "Blue Book", the OECD recognised that "There is no scientific basis for specific legislation to regulate the use of recombinant DNA organisms".

It was therefore going against this general trend that the Member States of the European Union began a negotiation process at the end of the 1980s, which ended in 1990 with the adoption of Directives specifically regulating the use of genetically modified organisms​.