Current procedures for applying risk assessment in genetically modified crops

The rapidly increasing utilization of transgenic cultivars in agriculture and emergence of genetically modified (GM) plants and plant products on the market calls for effective risk assessment procedures to be developed and applied in handling applications for GM plant release and marketing. The main producers of transgenic crops are at the same time also major exporters of agricultural products. Therefore there is an urgent need to develop internationally standardized and consistent schemes, test procedures and concepts of risk assessment. In this paper the procedures of risk assessment of transgenic are reviewed with special reference to procedures adopted by the European Union as exemplified in EU Directive 90/220, and procedures enforced in the USA. Special attention is given to the principle of substantial equivalence of the transgenic plant and the receiver plant as it was developed in the USA in the context of the dispute over labeling & consumer choice and precautionary principles as stressed in Europe. An example of general procedure is presented as proposed by the Danish group in the form of a three-step hierarchical frame for risk assessment. The main idea of the hierarchical procedure is that experimental tests and model simulations of varying complexity are applied at each level: individual plant, populations and the ecosystem. The perspectives of the adoption of generally accepted concepts and procedures of risk assessment are discussed.