By Peter O'Donnell

BioWorld International Correspondent

BRUSSELS, Belgium - Another biotechnology genetically modified product won scientific approval from the European Union - the second such decision in just more than two months.

The European Food Safety Authority decided that Monsanto Co.'s genetically modified GT73 oilseed rape was safe for human consumption and presented no more risk than conventional rapeseed. The agency in December gave scientific clearance to a biotech maize, NK603.

The opinion came from the authority's Scientific Panel on Genetically Modified Organisms. It said, "The placing on the market - for import, processing and feed use - is unlikely to have an adverse effect on human or animal health or, in the context of its proposed use, on the environment."

A favorable response to import and process the product - but not to cultivate it - in the EU initially was made by the Netherlands. However, several other EU member states raised questions about its allergenic risk, pesticide residues, the need for additional feeding trials and the environmental monitoring plan.

The authority's panel concluded that additional animal feeding studies are not necessary. The oilseed rape was genetically modified with two genes encoding proteins conferring glyphosate tolerance. One of the proteins is glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). The EPSPS activity is needed for the biosynthesis of aromatic amino acids in plants and in microorganisms; the plant enzyme usually is sensitive to glyphosate, thereby causing the plants to be killed by the herbicide.

The second protein is glyphosate oxidoreductase, which acts by breaking down glyphosate.

Molecular analysis showed that GT73 contains a single inserted copy of the DNA present in the construct used for the transformation. There are some molecular changes at the insertion site, which do not lead to new traits and are not considered a safety risk. In the event that a new peptide or protein is introduced as a consequence of the insertion event, bioinformatics analysis showed that those would have no homology to known toxins or allergens.

The opinion also agrees with the conclusions of the applicant's own environmental-risk assessment that the likelihood of unintended environmental effects due to the release and spread of GT73 oilseed rape would not be different from that of traditionally bred oilseed rape.

However, the opinion is only advisory. GT73 - like NK603 - now has to await a view from EU member state ministers at a future meeting of the EU Council of Ministers, when national governments will make clear whether or not they wish to authorize GT73 for importation. If ministers fail to reach a clear decision, senior EU officials will then be entitled to make a decision themselves.

Structural Genomics Receives Research Funding

European research into structural genomics has been given a €10 million boost by the European Union, which is funding the creation of a European platform for scientists working in the field of biological crystallography.

Known as Bioxhit, the project will bring together 27 partners from 17 countries. At specific new centers, work will be carried out jointly to develop 3-dimensional "architectural" models of biological molecules. The money will help to improve the sample-handling process and to acquire the equipment to identify X-ray patterns and the computers and software to model structures.

"This grant will definitely make Europe a substantial player in this area," according to a statement from Victor Lamzin of the European Molecular Biology Laboratory, which is coordinating the project. He said the alliance would allow Europe to be "a major competitor in structural genomics on a global scale."

German Coexistence Plan Wins Praise

Germany's plans to guarantee coexistence between GM and non-GM crops won the backing of Denmark, Italy, Luxembourg and Austria last week at the European Union meeting of agriculture ministers. Germany presented the EU Council of Ministers with its draft national legislation, which clarifies liability questions and foresees specified management measures. That is the first of the EU member states to present its plan and it is receiving attention, since all EU countries are under an EU obligation to introduce controls in the coming years. Denmark also is at an advance stage on legislation that would require specific licenses for GM producers and rules on distances between GM and conventional crops. Supporters of the German approach argued in favor of more coordination on GMO legislation at the EU level and for shared information among the member states. But other member states are less in favor of a "one-size-fits-all" approach and want to use the EU rules that allow for specific national conditions.

European Industry Network To Encourage Research

National associations of the biotechnology industry across Europe have won funding from the European Union to create a network that will strengthen cooperation between academics, small firms and all other operators that could benefit from biotechnology. The associations will work with smaller firms to help identify their needs and to provide them with information on how EU research funding can help them tackle technological and market issues. The project will help small firms access information on EU research funding possibilities.

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