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Monitoring genetically modified organisms

Monitoring of the impacts of genetically modified organisms and their use on human health and the environment is mandatory under the EU Deliberate Release Directive (2001/18/EC) and the Regulation on Genetically Modified Food and Feed (Regulation (EC) No 1829/2003). The EU monitoring requirements were enacted in German law in 2005 in legislation amending the Genetic Engineering Act (GenTG). Specific requirements on monitoring were then incorporated into the Genetic Engineering Act for the first time.

The purpose of monitoring is to verify approval decisions and safety precautions on the ground and improve the predictive accuracy of future environmental risk assessments. Monitoring serves as an early warning system, enabling a rapid response and damage limitation in the event of expected and unexpected adverse effects on human health and the environment.

The Genetic Engineering Act (Section 16c (2)) distinguishes between case-specific monitoring and general surveillance.

  • The objective of case-specific monitoring is to confirm any assumption made in the environmental risk assessment regarding the occurrence and impact of potential adverse effects of the genetically modified organism or of its use;
  • The objective of general surveillance is to identify the occurrence of any adverse effects of the genetically modified organism or of its use on human health or the environment that were not anticipated in the environmental risk assessment.

Whereas the performance and scope of case-specific monitoring is based on the findings of the environmental risk assessment, general surveillance is largely independent of this and is mandatory. General requirements as to the design of monitoring are set out in Annex VII of the Deliberate Release Directive (2002/811/EC) and supplementary guidance notes.

 BfN is involved in the enforcement of the Genetic Engineering Act in its capacity as consultant authority and assesses monitoring plans and reports from a nature conservation perspective. Assessment reports are passed on to the Federal Office of Consumer Protection and Food Safety (BVL), which incorporates the positions of the various authorities involved into a national position and submits this to the European Commission.

Implementation of GMO monitoring

To secure meaningful and effective monitoring of adverse effects and remove current weaknesses in monitoring plans, BfN and the National Environment Agencies of Austria and Switzerland compiled a policy paper on the monitoring of genetically modified organisms.

The specific implementation and targets of GMO monitoring are decided on a case-by-case basis, meaning that monitoring must be specially tailored to each individual GMO and its use. This is based on the environmental risk assessment, identified uncertainties, the targets of protection and hypothesis-based cause-effect relationships. Suggestions for the required monitoring parameter are available for genetically modified insect-resistant maize, herbicide-tolerant oilseed rape and modified starch potatoes (e.g. Züghart & Breckling 2003; B/L-AG 2003). A European Commission working group on GMO monitoring has compiled checklists of parameters to be used in monitoring for these three transgenic crops.

Implementing GMO monitoring involves the development of new methods or the adaptation and improvement of existing methods. To ensure that survey methodologies are as meaningful as possible and that the data can be analysed and compared, coordinated and standardised monitoring methods are needed at national and European level. For this purposes, experts under the aegis of the Association of German Engineers (VDI) have compiled a large number of VDI guidelines on GMO monitoring. The results of this work were published in 2013 (Biorisk Journal).

It generally makes sense to combine GMO surveillance with existing monitoring programms and to make use of other available monitoring data. Directive 2001/18/EC likewise recommends that use should be made of established agricultural monitoring, environmental observation and conservation programmes where suitable. BfN is therefore tasked with examining existing national environmental monitoring programmes for use in GMO surveillance and developing models for their integration.

Licence holders must report on the performance and outcomes of monitoring at regular intervals. Monitoring reports can be viewed on the BVL website.

Last Change: 18/04/2018

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