Aug 4, 2006

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BVL on the Bt maize debate

“This is a tested, safe product “

In mid-July, the environmental organisation Greenpeace published a study evaluating the latest findings of research into the environmental effects of genetically modified Bt maize Mon810. The conclusion drawn by Greenpeace is that Bt maize poses a threat to the ecological balance. Scientists at RWTH Aachen University and at the Federal Agricultural Research Centre (FAL), who are involved in BMBF safety research projects, have since distanced themselves from Greenpeace’s interpretation of their research results. In the study, the authorisation authority is accused of having failed to test the effects of GM maize on biological diversity in Europe sufficiently. GMO Safety spoke to Detlef Bartsch of the Federal Office of Consumer Protection and Food Safety (BVL).

GMO Safety: In its study published in mid-July, Greenpeace refers to the Mon810 event as a “problematical product”, says that its authorisation is “not compatible with the precautionary principle embedded in EU law” and demands that the EU authorisation be withdrawn. How do the relevant authorities in Germany assess this evaluation?

Detlef Bartsch: As the responsible upper authority at national level, the BVL continues to be of the opinion that, according to current scientific knowledge and applying the precautionary principle, MON810 is a tested, safe product. New results – from BMBF safety research projects for instance, or from environmental monitoring – are being followed carefully by the BVL. If new findings lead to a different safety assessment, suitable measures will immediately be taken to protect human health and the environment.

GMO Safety: Mon810 has been authorised for cultivation since 1998. Five varieties are approved and a further eight are undergoing variety testing at the Federal Office of Plant Varieties (Bundessortenamt). The first authorisation of MON810 was granted under the old Deliberate Release Directive 90/220/EEC. This has since been replaced by new legislation – the new Deliberate Release Directive 2001/18EC and Regulation 1829/2003/EC on genetically modified food and feed. This means that MON810 must be reassessed on the criteria of the current EU Directive. What criteria must be met in order for Mon810 to continue to be authorised for cultivation?

Detlef Bartsch: The EU Directive sets out clearly which documents must be assembled for the authorisation of a GMO. Under Directive 2001/18EC and Regulation 1829/ 2003/EC the requirements to be met by applicants have increased. For instance, they now have to provide a more detailed description of the genetic modification and a more intensive environmental risk assessment. A new element of the application is a monitoring plan for monitoring the GMO in the environment. The BVL will draw on results from ongoing safety research in its assessment of the application documents.

GMO Safety: In your view, are there currently any findings, e.g. from the completed BMBF group project on biosafety research, which necessitate a reassessment of the Bt maize Mon810? And can results from German cultivation areas be transferred to other EU countries?

Detlef Bartsch: The BVL is aware of the results of the BMBF safety research into MON810 maize. In the BVL’s judgement, they do not give grounds for a reassessment. I believe that the results can be transferred to other EU countries. But one always needs to check whether there are special regional characteristics that need to be taken into account, like different climate conditions. It is interesting that other European scientific field studies, e.g. in Spain and France, are producing similar results.

GMO Safety: Ecosystems are very complex. How is it possible, within a safety assessment, to ensure that Bt maize does not have unexpected effects on the environment?

Detlef Bartsch: In the environmental risk assessment, there are a number of points to be looked at in a safety assessment based on the organism concerned and the genetic modification. Take the example of Bt maize: Bt maize produces Bt toxin which combats a butterfly pest, the European corn borer. The effect is not limited to the butterfly – it also affects other species of butterfly. Here we need to check whether so-called non-target butterflies are endangered by the cultivation of Bt maize. On the other hand, the pest could develop resistance, which could mean that farmers have to go back to using pesticides that are more harmful to the environment. After the product is authorised, applicants must carry out case-specific monitoring of any risks identified.

Generally, genetically modified plants are initially released under glass and later in the field for scientific purposes and usually on a limited area. Strict conditions have to be met to prevent the plants from outcrossing or being moved out of the area. It is only once these trials have ruled out negative effects on humans, animals and the environment that commercial cultivation can be considered.

Nevertheless, unexpected effects could arise, even after years of research. It is not possible to investigate unexpected effects in advance at the environmental risk assessment stage because we do not know in advance what these effects are and do not know what to test for. Unexpected effects can be managed through product monitoring after authorisation. This is why general surveillance has recently been prescribed in the genetic engineering legislation. The aim is to identify unusual harmful effects on the environment or on human or animal health. Lots of scientists agree that this can be achieved through the monitoring of so-called protection targets. A protection target could be biodiversity, sustainable agriculture or soil fertility. If harmful unexpected effects resulting from the cultivation of GMOs are found, suitable measures can be taken to avert the danger – up to and including a total ban.

GMO Safety: Thank you for talking to us