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(32-07) Evaluating Safety Evaluations of GMO Products. Spoek, Armin*,1, Gaugitsch, Helmut2, Hofer, Heinz3, Kienzl-Plochberger, Karin4, Lehner, Petra5, Valenta, Rudolf6, 1 Inter-University Research Centre for Technology, Work and Culture, Graz, Austria2 Federal Environment Agency, Vienna, Austria3 Austrian Research Centers, Seibersdorf, Austria4 Matznergasse 8, Vienna, Austria5 Gschwandnergasse 42, Vienna, Austria6 Department of Pathophysiology, Vienna, Austria ABSTRACT- The safety evaluation of genetically modified organisms (GMOs) as or in products is dependent on their subsequent application. Most products e.g. seeds, commercial cultivars, feed stuff and intermediates for processing in various areas of industry are currently evaluated under EU Directive 90/220/EEC which will be soon replaced by Directive 2001/18/EEC. In the context of Directive 90/220 also a toxicological safety evaluation has to be carried out by the applicants which is then thoroughly reviewed by national competent authorities and by EU-scientific committees. So far, 30 applications have been evaluated or are still under evaluation, most of them seeking for approvals of genetically modified crops. Safety evaluation and especially toxicological evaluation of GMO products was frequently criticised e.g. in the case of the transgenic Monsanto Soya bean and more fundamentally challenged by various scientific publications. Regardless to these critique it has to be mentioned that only a few or even no details for toxicological safety evaluation are specified by EU regulations. This is especially true for Directive 90/220/EEC. In order to shed light upon the practice of toxicological safety evaluation we investigated 11 Directive 90/220 application dossiers. This investigation focused on potential toxic including allergic properties and on the application of the concept of substantial equivalence which is used as a decision tool in the safety evaluation procedure of GMOs. An in-depth analysis was performed for feeding studies. In a first step the toxicological safety evaluation in the dossiers was thoroughly reviewed and comparatively analysed. We looked at the general approach including the reasons given, the way the actual exposure is layed down, the toxicological testing performed , data display and the conclusions drawn. From these analyses it can be concluded that the practice of toxicological safety evaluation was carried out in a different way by applicants. Moreover, in many cases toxicity evaluation was done just by assumption based reasoning and not based only on facts. On the basis of these results we propose a set of measures in order to standardise the toxicological safety evaluation and thereby contribute to the further harmonisation and improvement of safety evaluation of GMO products. Key words: genetically modified organism, biotechnology, risk assessment, regulation |
