BioWorld International Correspondent
BRUSSELS, Belgium - European Union health authorities desperately are trying to untangle the confusion over unauthorized release in Europe of Syngenta's Bt10 genetically modified maize, which has entered Europe labeled as if it were authorized Bt11.
Unlike Bt11, Bt10 includes the gene conferring resistance to the antibiotic ampicillin, the EU learned on March 31. It has not yet been authorized in any country.
Following revelations that up to 10 kg of Bt10 seed have been exported inadvertently to Spain and France for research purposes, the EU is seeking urgent clarification from U.S. authorities and Syngenta. It has requested all available safety information, including the full risk assessments, and has asked for an urgent audit to provide an official U.S. view about how much has been exported, and where the exports might have gone inside the EU.
The EU also has asked Syngenta to release full information about the molecular characterization of Bt10 and its distinction from Bt11, as well as the specific detection method and adequate reference materials to trace Bt10.
The crops resulting from the consignment have been destroyed, but at the same time, the EU is facing the consequences of another, larger, oversight. It has emerged that about 1,000 metric tons of Bt10 food and feed products might have entered the EU through the Bt11 export channels since 2001, the date from which the inadvertent release of Bt10 started.
The EU's top official for health and consumer protection, Markos Kyprianou, on April 1 publicly deplored the import. He said that contacts were under way with U.S. authorities to "guarantee, by taking the appropriate measures, that present and future exports of maize to the EU do not contain GMOs that are not authorized for the EU market, including Bt10."
The EU's senior environment official, Stavros Dimas, played down the risks: "In order to avoid any adverse effect on human and animal health or the environment of such an accidental release, the commission has asked member states to carry out appropriate control measures to stop Bt10 entering their territory," he said. Member states are being asked to notify the EU authorities of any past or current national experimental releases of Bt11, and to implement appropriate monitoring measures in the surrounding areas in which any releases took place.
The U.S. Mission to the European Union reported on March 22 an inadvertent release in the U.S. of the non-authorized Bt10. The U.S. offered reassurances that no food, feed or environmental concerns are associated with the inadvertent release, basing its argument on the similarity of Bt protein in Bt10 to the one in Bt11, which is fully authorized in the U.S. and which the EU has cleared for use in food and feed. EU civil servants accordingly informed the member states via the EU's rapid alert system for food and feed.
But the EU now is complaining that the U.S. did not make clear that Bt10 contains the gene conferring resistance against ampicillin, and that it was only via Syngenta on March 31 that the information emerged. The European Food Safety Authority said the ampicillin-resistance gene should not be present in crops grown commercially.
The embarrassment for EU authorities is all the greater, since Europe is still locked in a battle over the credibility of EU controls on the release of biotechnology products. European opponents of biotechnology have pointed to what they see as flaws in the EU's claims that its biotechnology legislation adequately protects public health and the environment. Now the critics of EU policy feel they have been dealt a trump card.
Friends of the Earth Europe immediately accused Syngenta of misleading governments and the public, and flying in the face of concerns that the genes in Bt10 could flow from crops to micro-organisms and spread problems of antibiotic resistance in humans and animals. It demanded "immediate action to ensure that foods which aren't permitted for human consumption are removed from the food chain."
New EU Moves On Pharmacogenetics
The European Medicines Agency is working on new guidelines for developing medicines based on pharmacogenetics - including biobank issues, and how companies looking to market new products can best share scientific and technical information.
The agency's starting point with both guidelines - on which it is seeking industry comment through June - is that pharmacogenetics information might allow regulators to optimize the evaluation of the balance between benefit and risk, and to provide more focused information for prescribers and patients.
But while pharmacogenetics testing in clinical trials and large-scale epidemiological studies will be increasingly considered in pre- and post-approval development and assessment of medicines, the agency said, the use of genetic data for those purposes could raise new regulatory issues.
"There remains a need to reflect on the integration of general principles and specific issues applicable to the bio-banks holding samples and data for pharmacogenetics use in research, development and assessment of medicinal products both in pre-authorization and post-authorization phases," said the agency's draft guideline.
Biobanks - which the agency defines as collections of samples of human cells, tissue, blood or DNA that can be associated with personal data - need closer regulation, the agency said. And while the agency's recently established pharmacogenetics working party ensures reflection on the underlying issues, "the pharmacogenetics knowledge base is still at an early stage." So companies planning preliminary discussions with agency experts should provide at least four weeks in advance an outline of the key issues they wish to address with agency experts, linked to the relevant therapeutic area.