EFSA launches public consultation on guidance for environmental risk assessment of GM plants

EFSA has launched a public consultation on the revised guidance of its GMO (Genetically Modified Organisms) Panel for the environmental risk assessment of GM plants. EFSA provided updated guidance for assessing the impact of GM plants on the environment and held discussions with stakeholders and Member States as part of this work. Together with new, strengthened requirements in terms of data generation, collection and analysis, this guidance also contains a revised section on the evaluation of possible effects on non-target organisms. The document is the result of two years’ work and demonstrates EFSA’s commitment to staying at the forefront of recent developments in the field of GM plant environmental risk assessment. The public consultation will last until 30 April for a total of eight weeks.

EFSA reviewed and updated the specific areas that need to be addressed when assessing the environmental impact of a GM plant. These cover in particular the persistence and invasiveness of the GM plant, taking into account plant-to-plant gene transfer; the likelihood and consequences of gene transfer from the plant to micro-organisms; the potential evolution of resistance in target pests; the impact of the GM plant on non-target organisms; and the impact that the cultivation, management and harvesting techniques associated with the GM plant may have. Specific attention was also given to other environmental processes that may be affected by the GM plant, as well as to the impact that these may have on human and animal health.

EFSA also supplemented its guidance document with specific aspects which will need to be taken into consideration for the assessment. Detailed requirements are given for the choice of appropriate non-GM comparators (which are the non-GM plants with which the GM plant is compared during the safety evaluation) and types of receiving environments to be considered; the experimental design of laboratory and field studies, and their statistical analysis; and the consideration of possible long-term effects.

Some GM plants can produce an insecticide which wards off attacks from certain insects and it is important to ensure that they do not adversely affect other insects (the so called non-target organisms or NTOs). In the context of its work on the new guidance, the GMO Panel produced a scientific opinion on how to evaluate the impact of a GM plant on non-target organisms. The opinion defines criteria for the selection of relevant non-target species; for the identification of those aspects of the environment that need to be protected from harm; and for the experimental design of laboratory and field studies and their statistical analysis.

The revision of the guidance document was undertaken in response to a request from the European Commission. To complement this, EFSA undertook work on non-target organisms on its own initiative. Also, a series of technical discussions was organised to bring together GMO Panel experts, stakeholders and technical experts from the EU Member States to exchange views on the scientific issues and various aspects of the documents[1]. At the end of the public consultation launched on 5 March, EFSA will publish a report with an overview of the comments received and will address the relevant comments in the final EFSA GMO Panel guidance document and related opinion on non-target organisms.

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