Jul 20, 2009

Basic info

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Compulsory monitoring

General and case-specific monitoring

Genetically modified plants are now approved in Europe only if the applicant presents a detailed monitoring plan. Should unexpected negative effects occur after approval has been granted, they can be detected through systematic monitoring. Depending on the intended purpose of the GM crop – cultivation, import, feed or food – monitoring can focus on possible environmental effects, but also on compatibility with human and animal health. The monitoring plan is assessed by the European Food Safety Authority (EFSA) and forms part of the approval of each GM plant.

Diagram: From experimental biosafety research to environmental monitoring of genetically modified plants.

Before they can be cultivated on a large scale, genetically modified crops are subject to comprehensive safety checks. Authorisation to cultivate the crop is given only if no harmful effects can be expected for human health or the environment. Laboratory, greenhouse and release trials provide an important basis for decision-making when it comes to the environmental compatibility test.

The post-market environmental monitoring, which is prescribed both in the EU’s Deliberate Release Directive 2001/18 and in the Regulation on Genetically Modified Food and Feed (1829/2003), begins with the cultivation approval for a genetically modified plant (see diagram). The idea is for further information to be gathered during agricultural cultivation about the interrelationship between the GM plant and the environment. In particular, the assumptions made in the environmental compatibility test – e.g. concerning the effects on biodiversity of flora and fauna – need to be checked under farming practice conditions. A further objective is the early detection of unforeseeable or unexpected effects.

The environmental monitoring programmes for genetically modified plants are based on two approaches:

• The aim of general surveillance is to record any unexpected or long-term harmful effects of genetically modified crop plants. General surveillance uses an approach based on protection targets such as biodiversity or conservation of soil fertility.
• Case-specific monitoring checks the results and assumptions reached in the environmental impact assessment. For example, in the case of genetically modified pest-resistant Bt maize, case-specific monitoring will monitor the emergence of resistant pests.

The monitoring plan for a particular GM plant (or ‘event’) must be drawn up and implemented by the applicant. The EFSA examines it and gives its opinion on whether the monitoring plan is scientifically well founded and adequate, and whether a case-specific monitoring plan needs to be added. The GMO Panel, a scientific panel of experts on genetically modified organisms set up within the EFSA, is responsible for the expert examination and evaluation of the plans.

General surveillance is obligatory for all GM plants requiring authorisation. Existing agricultural environmental and nature conservation monitoring programmes can also be used in individual cases. And it is also possible to send systematic questionnaires to the farmers cultivating the GM crop in question.

So far, no genetically modified plant has been authorised for cultivation in the EU under the new legal framework. The only applications that have been approved so far concern the import of GM plants and their use as food and feed. The monitoring plans submitted for these authorisations and other applications have been checked and evaluated. They are published on the EFSA website and in the Community Register of GM Food and Feed.

In the case of genetically modified Bt maize MON810, which was approved under the old EU legislation, the licensee was ordered to introduce a monitoring plan in spring 2008. MON810 is currently the only GM crop grown in Europe.

If authorisation to cultivate the plant is granted, the EU states in question are responsible for supervising the monitoring. In Germany responsibility lies with the regional authority of the Land in which the crop is grown.