Abstract

Background and purpose: In Europe, the EU Directive 2001/18/EC lays out the main provisions of environmental risk assessment (ERA) of genetically modified (GM) organisms that are interpreted very differently by different stakeholders. The purpose of this paper is to: (a) describe the current implementation of ERA of GM plants in the EU and its scientific shortcomings, (b) present an improved ERA concept through the integration of a previously developed selection procedure for identification of non-target testing organisms into the ERA framework as laid out in the EU Directive 2001/18/EC and its supplement material (Commission Decision 2002/623/EC), (c) describe the activities to be carried out in each component of the ERA and (d) propose a hierarchical testing scheme. Lastly, we illustrate the outcomes for three different crop case examples. Main features: Implementation of the current ERA concept of GM cr ops in the EU is based on an interpretation of the EU regulations that focuses almost exclusively on the isolated bacteria-produced novel proteins with little consideration of the whole plant. Therefore, testing procedures for the effect assessment of GM plants on non-target organisms largely follow the ecotoxicological testing strategy developed for pesticides. This presumes that any potential adverse effect of the whole GM plant and the plant-produced novel compound can be extrapolated from testing of the isolated bacteriaproduced novel compound or can be detected in agronomic field trials. This has led to persisting scientific criticism. Results: Based on the EU ERA framework, we present an improved ERA concept that is system oriented with the GM plant at the centre and integrates a procedure for selection of testing organisms that do occur in the receiving environment. We also propose a hierarchical testing scheme from laboratory studies to field trials and we illustrate the outcomes for three different crop case examples. Conclusions and recommendations: Our proposed concept can alleviate a number of deficits identified in the current approach to ERA of GM plants. It allows the ERA to be tailored to the GM plant case and the receiving environment.

Highlights

  • Background and purposeIn Europe, the European Union (EU) Directive 2001/18/EC lays out the main provisions of environmental risk assessment (ERA) of genetically modified (GM) organisms that are interpreted very differently by different stakeholders

  • Based on the EU ERA framework, we present an improved ERA concept that is system oriented with the GM plant at the centre and integrates a procedure for selection of testing organisms that do occur in the receiving environment

  • We propose a hierarchical testing scheme from laboratory studies to field trials and we illustrate the outcomes for three different crop case examples

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Summary

Introduction

Background and purposeIn Europe, the EU Directive 2001/18/EC lays out the main provisions of environmental risk assessment (ERA) of genetically modified (GM) organisms that are interpreted very differently by different stakeholders. Testing procedures for the effect assessment of GM plants on non-target organisms largely follow the ecotoxicological testing strategy developed for pesticides This presumes that any potential adverse effect of the whole GM plant and the plant-produced novel compound can be extrapolated from testing of the isolated bacteriaproduced novel compound or can be detected in agronomic field trials. ‘Delayed effects’ are effects ‘which may not be observed during the period of the release of the GMO but become apparent as a direct or indirect effect either at a later stage or after termination of the release’ [2]. The current implementation of ERA falls short of complying with the EU regulations

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