Incident details
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Europe - European Commission says 1,000 tonnes illegal Sygenta's Bt10 maize imported into Europe.
The Commission confirmed on 1 April that around 1000 tonnes of Syngenta's illegal Bt10 GM maize has entered the European food chain. Up to 10 kg of Bt10 seed may have been exported inadvertently as Bt11 for research purposes to Spain and France. The Commission has written to the United States and to Syngenta for more information.
The mix up arose because Syngenta’s quality control procedures were not sufficiently rigorous and did not differentiate between Bt10 and Bt11. As a result, Bt10 lines were mistakenly used in breeding. The error was detected after four years, when one of the seed companies developing Bt11 varieties, Garst seeds, used more sophisticated techniques.
The GM maize is modified to be resistant to certain insect pests by the insertion of a Bt toxin gene from the bacterium, Bacillus thuringiensis. Bt10 also contains a marker gene that codes for the widely used antibiotic, ampicillin. According to the international Codex Alimentarius Guideline for Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants:
“Antibiotic resistance genes used in food production that encode
resistance to clinically used antibiotics should not be present in
foods.”
On May 25th 2005, Ireland notified the European Commission and other Member States that Bt10 had been found in a shipment of maize gluten.
In October 2005, the European Commission reviewed the situation relating to imports of Bt10 maize. Around 1400 tests were reported to have been conducted on food and feed with no Bt10 detected. There was a lot of variation between countries in level of testing. One country (unnamed) had conducted 1200 of these tests and another only one.
However, in April 2006, the European Commission sent a letter to Syngenta about the reliability of the detection method because the official testing validation agency, the Community Reference Laboratory for GMOs for Food and Feed, based at DG Joint Research Centre (JRC), had raised concerns that it could not exclude "false negative" results (i.e. negative results where Bt10 was not really absent). New information on the structure of Bt10 provided to the JRC by Syngenta, was inconsistent with earlier information, leading to the concerns.
In the US, a Department of Agriculture investigation led to a $375,000 fine and Syngenta's was required to hold a compliance seminar. Under the terms of Syngenta's agreement with the USDA, the conference was to have the following goals:
“1.) develop a best management practices or technical guideline for insuring no contamination or cross contamination of biotech genes in the seed development and breeding program; and
2.) develop a best management practices or technical guideline to identify, promptly address, and implement corrective measures to resolve unintended biotech releases”.
The conference was held on December 6, 2005 at the annual American Seed Trade Association meeting held in Chicago. For a copy of a DVD of the proceedings and the power point presentations contact:
Lisa Zannoni
Head, Global Biotechnology Regulatory Affairs
Syngenta
e-mail: lisa.zannoni@syngenta.com
The GM Contamination Register Report for 2005 has a special section on the Bt10 incident containing further details and references. It accessible via the downloads section in the left hand panel of this page.
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Further information
Bt10: Ireland notifies contaminated consignment stopped in port - European Commission Press Release
25th May 2005 >
Syngenta press release 21st March 2005. >
Syngenta statements on Bt10. >
Macilwain, C. (2005) US launches probe into sales of unapproved transgenic corn Nature 434: 423 >
European Commission Press Release 1st April 2005. Commission seeks clarification on Bt10 from US authorities and Syngenta. >
Committee on the food chain and animal health. Section GM food & feed and environmental risk. Summary record of the 8th meeting –27th October 2005 Bt10: Review of Decision 2005/317/EC on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize products. >
European Commission Media Release. GMOs : Commission requests information from Syngenta to confirm reliability of detection method for Bt10 maize
April 4, 2006 >
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