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| Biography |
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Willy De Greef is a plant biologist with extensive experience in tropical crop breeding (through research management positions in Congo, Malawi and Cameroon) and in technology transfer related to agricultural biotechnology. He has been head of regulatory affairs for two biotechnology leaders, Plant Genetic Systems in the 1980S, and Syngenta Seeds from the late 1990s. He has been involved in the policy and public debate around agricultural biotechnology since 1986 (OECD, UNIDO, Biodiversity Convention, Cartagena Biosafety Protocol) and involved in the development of the regulatory framework since then. He is currently head of the consultancy company International Biotech Regulatory Services, based in Belgium, and specialises in the development of rational regulatory frameworks for biotechnology for developing countries and in capacity building for biotechnology researchers in the developing world in biosafety assessment and regulatory compliance.
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| Abstract |
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The 20th anniversary of the OECD Blue Book: taking stock |
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Twenty years ago OECd published a document titled “Recombinant DNA safety considerations”, the outcome of three years of work by a group of experts charged with creating common technical guidance for the evaluation of safety in GMOs. It became known in the biotech community as “the Blue Book”. This set of guidelines today is still the basis of the national regulations in almost all countries that have set up a regulatory framework for agricultural biotechnology.
The quality of the Blue Book is best demonstrated by the fact that in the time since its publication more than 20000 experimental field releases have been managed safely, and since 1995 a total of over 400 million hectares of GM crops have been grown and consumed safely. Nevertheless, the Blue Book is under pressure from two opposing sides:
• The Cartagena Protocol on Biosafety is undermining the technical basis of the Blue Book, most clearly in its drive to do away with the “step by step” assessment procedures.
• The progress in GM technology is inevitably leading to new technologies and products which put technical stress on the approaches to risk assessment of the Blue Book.
There is an urgent need for a new dialogue to deliver an up to date new set of internationally accepted technical guidelines for the further development of GM crops. |
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