EU contacts US authorities for details on Bt10

07/04/05 The European Commission has written to the US authorities and to the biotechnology company Syngenta requesting clarification of the situation regarding the unauthorized genetically modified maize Bt10.

According to the information received to date from the US authorities and from Syngenta, the developer of Bt10, up to 10 kg of Bt10 seed may have been exported inadvertently as Bt11 for research purposes to Spain and France. The resulting materials have all been destroyed. In addition, the Commission is informed that an estimated 1000 metric tonnes of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001, the date from which the inadvertent release of Bt10 started. At a meeting yesterday with representatives of Syngenta, officials of the European Commission were informed that Bt10 included the gene conferring resistance to the antibiotic ampicillin.

The Commission was first informed by the US Mission to the European Union on 22 March about an inadvertent release in the US of a non authorized genetically modified maize line called Bt10. The Commission informed the Member States without delay via the Rapid Alert System for food and feed. Moreover, the Commission has asked the US Administration for the full safety information about Bt10 at its disposal without delay, including the full risk assessments upon which it is based as well as for an urgent audit and an official view as to the quantities exported, including the channels they may have taken in the EU.

The Commission has also asked Syngenta, the developer of the Bt10 crop, to release the full information about the molecular characterisation of Bt10 and its distinction from Bt11, as well as the specific detection method and adequate reference materials to trace Bt10. The Commission has also asked Syngenta to confirm that all Bt10 plantings and seed stock in the USA have been destroyed or isolated for further destruction. Syngenta has committed to provide this information next week.

The US government has given reassurance that no food, feed or environmental concerns are associated with the inadvertent release of this non authorized genetically modified crop, based on the fact that the Bt protein in Bt10 is similar to the one in Bt11, which is fully authorized in the US and which the EU has authorized for use in food and feed.