BRUSSELS, Belgium - The European Commission is defending the genetically modified Bt maize authorized for use in the European Union, a product to which Germany is objecting.

Countering allegations from Green group Euro-MP Bart Staes that this maize carries an unquantified risk of "adverse spillover effects" of the "natural" poison produced by it, European Environment Commissioner Margot Wallstrvm pointed out that "comprehensive risk assessment" of any impact on health or the environment was carried out on the product before authorization.

The two genetically modified maize varieties expressing the Bacillus thuringiensis toxin that confers insect tolerance that have been authorized for use in the EU were the subject of consultations with the independent scientific committees set up by the Commission, she said, and favorable opinions appeared in December 1996 and February 1998, with a further re-assessment in September 1999. "The Commission is aware that Bacillus thuringiensis has been used for a long time in organic agriculture, apparently with a good safety record," Wallstrvm said.

Germany has objected to the marketing of the products because of findings in an experimental study on exudates of the insecticidal toxin from insect-resistant corn plants, which was published in Nature at the end of 1999. Wallstrvm said the German objection - under EU safeguard provisions that allow for member states to raise concerns based on risk to human health or the environment - will be examined by the Commission's scientific experts, and the Commission will decide on its action in the light of its experts' findings.

Advisory Group Releases Consultation Papers

The EU's principal scientific committee on medicines, the Committee for Proprietary Medicinal Products, has released new consultation papers on biotechnology drug development. The CPMP's biotechnology working party has developed a position statement on the use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products, on which comments are invited until October.

The CPMP's proposed note for guidance on plasma-derived medicinal products also has been revised by the biotechnology working party, and comments are being invited until the end of September. At the same time, the CPMP has adopted a report of expert discussions on human transmissible spongiform encephalopathies and plasma-derived medicinal products.

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