[img_assist|nid=175|title=|desc=|link=none|align=right|width=100|height=43]This new report, written on behalf of Greenpeace, shows that no serious investigation was conducted on the effects of Bt11 maize on the environment and on animals feeding on it. Why does EFSA accepts a notification that lacks so much information, and why does it discard the existing scientific literature?
The report shows that no serious investigation was conducted on the toxicity of this GM maize or its impact on the environment, such as detrimental effects on useful or protected insect species. Furthermore, already published scientific results on possible negative environmental consequences of this GM maize were widely ignored by EFSA.

The report comes at a time when EFSA is challenged by consumer, environmental and health groups to put public and environmental safety before commercial interests. The call came as EFSA began a new Stakeholder Platform in Parma, Italy. The organisations welcomed the initiative by EFSA to listen to the views of stakeholders but urged EFSA to make serious changes in its work and procedures (press release).
Already in November 2004, Friends of the Earth published Throwing caution to the wind, a detailed critique of the EFSA and its work on GM foods.

Bt11 - Executive Summary

[img_assist|nid=176|title=|desc=|link=url|url=http://www.ifrik.org/files-ifrik/Greenpeace_report-on-bt-11-maize_2005.pdf|align=right|width=250|height=255]On 20 May 2005 European Food Safety Authority (EFSA) delivered a positive opinion on Syngenta’s application for insectresistant genetically modified (GM) maize Bt11.

The notifier (now Syngenta) applied for the approval to cultivate Bt11 maize in the European Union. Bt11 produces the Bt toxin Cry1Ab against Lepidoptera (moths and butterflies) to protect maize against the two insect pests European stem borer (ECB, Ostrinia nubilalis) and Mediterranean stem borer (MCB, Sesamia nonagrioides). In addition, Bt11 is herbicide-tolerant against the glufosinate-ammonium (BASTA, Liberty).The notifier claims that Bt11 will not be marketed for its herbicide tolerance, but in other countries, such as the USA and Canada, Bt11 is marketed forboth GM traits.

The application contains almost no original data about risk assessment studies, and in several cases the summaries make clear that the few studies that were undertaken lack scientific relevance for growing Bt11 in the field.They lack any study of medium or long-term effects, effects on European species (especially European butterflies) and studies on impacts on the soil biota. Even Member States stated that it would not be possible to draw positive recommendations from this limited data. Information about the actual insert, about the insertion site and possible additional, unintended inserts are classified as confidential business information, thereby making it impossible for third parties to undertake an independent assessment.

Bt11 should not be grown in the EU because:

• The notification lacks original data that would enable an independent assessment to be made of the studies undertaken and their results.
• The non-target studies are insufficient to enable a risk assessment to be undertaken, while the scientific literature gives enough indications of adverse effects of Bt11 on non-target organisms, including multitrophic interactions between plants, herbivores and pests. Effects on soil organisms have not been studied at all.
• There are unexplained irregularities in the molecular data discovered by independent scientists, including rearrangements and possible contamination with Bt176. A summary of a (otherwise as CBI classified) sequencing acknowledges the integration of several pieces of vector backbone DNA, but does not clarify the other irregularities found earlier in an independent study.The site of the insertion is a region where interruptions are likely to interfere with the basic metabolism of the GM plants.
• There are no sufficient data from feeding and toxicity studies.
• Bt11 is also tolerant to the herbicide glufosinate (brand name Liberty, Basta).This transgenic trait has not undergone any risk assessment, yet can have environmental effects; either directly or through changes in agricultural practices.
• The monitoring plan is inadequate. As even the EFSA points out, not enough attention is given to resistance development and adverse effects on non-target organisms. As well as farmers who are supposed to fill in questionnaires, but who might have conflicting interests, only a vague list of existing networks (including seed producers, and actors in the food and feed industry) is given without information on how such a monitoring exercise would work and whether these organisations are interested in participating. It has been acknowledged by the EFSA that some of these organisations lack the necessary scientific expertise.