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Licensing procedure for genetically modified organisms turns out to be fallible

The procedure used by Dutch, European and global authorities when granting licenses for genetically modified organisms is a flawed one. Although applicants are required to provide information about the dangers of the newly developed biotechnology to man and the environment, they themselves decide to some extent what information is relevant. This has been demonstrated by an analysis carried out by philosophers at Leiden University as part of a project funded by the NWOs Council for the Humanities. The applicant who is naturally an interested party is therefore in a position to influence the outcome of the approval procedure by deciding that certain information is irrelevant to the risk assessment.

The explanatory notes accompanying the questions on the current (Dutch) application form show that the governments decision whether or not to grant a license is based on the information provided by the applicant. It is stated, for example, that "synthesis of all the information provided in this application form is intended to result in a complete analysis of the risks." The questions which a biotechnology company is required to answer are phrased in general terms. For instance, applicants are asked about differences between the modified plant species and the original species and whether they expect hereditary changes to be spread within the environment. By formulating the questions in this way, the body awarding the licenses places the responsibility for the provision of information in the hands of the applicant.

The Leiden philosophers say that licenses can only be awarded in a responsible manner if the authorities have a list of questions which are relevant in assessing the dangers to man and the environment posed by modified organisms. As a start, they have drawn up a definition of the hazards posed by a modified organism, according to which a danger exists if "it carries an agent P which can produce an effect Q which is considered undesirable in context R
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Contact: Henk Klomp
klomp@nwo.nl
31-70-3440714
Netherlands Organization for Scientific Research
23-Jan-2000


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