Syngenta's unintended distribution across the European Union of a genetically modified corn variety that was not approved has got EU officials and environmental groups demanding answers from the biotechnology company and from the U.S. government. European officials were alarmed to learn from company representatives on Thursday that the unauthorized corn carries a gene that confers resistance to a widely used antibiotic.

Up to 1,000 metric tons of the engineered corn, or maize, was exported to the EU over a four year period between 2001 and 2004.

The European Commission said Friday that officials have written to the U.S. authorities and to Syngenta requesting clarification regarding Bt10, the unauthorized transgenic strain of maize developed by the company.

The Commission said it has learned from Syngenta that up to 10 kilograms (22 pounds) 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 said an estimated 1,000 metric tons of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001.

European officials are concerned about the health effects of Bt10. At a meeting Thursday with representatives of Syngenta, representatives of the European Commission were informed that "Bt10 included the gene conferring resistance to the antibiotic ampicillin," the Commission said.

Ampicillin is a penicillin drug used to treat bacterial infections.

The Commission was first informed by the U.S. Mission to the European Union on March 22 about an inadvertent release in the U.S. of a nonauthorized genetically modified maize line called Bt10.

But the U.S. authorities did not inform the Commission that Bt10 contains the gene conferring resistance against the antibiotic ampicillin. It was only on March 31 that this information was given officially to the Commission by Syngenta.

According to the advice of the European Food Safety Authority, the ampicillin resistance gene should not be present in crops grown commercially. According to Syngenta, this gene is inactive in Bt10.

"The European Commission deplores the fact that a GMO which has not been authorized through the EU’s comprehensive legislative framework for GMOs, nor by any other country, has been imported into the EU," said EU Health and Consumer Protection Commissoner Markos Kyprianou.

EU Health and Consumer Protection Commissoner Markos Kyprianou (Photo courtesy Office of the Commissioner)

"This case again shows the importance of the European Union’s comprehensive framework for traceability and labeling of GMOs," Kyprianou said. The EU traceability and labeling laws took effect in April 2004.

In the UK, Friends of the Earth has written to the Food Standards Agency demanding "an urgent investigation" into whether unapproved genetically modified maize has been illegally imported into the UK.

Over 16 thousand metric tons of U.S. maize was imported into the UK last year.

"The British public will be concerned that this unapproved GM ingredient may have found its way into food and animal feed, and will demand answers. The Food Standards Agency needs to urgently reassure us that this maize was not imported into the UK. And if it was it must ensure that any contaminated products are withdrawn immediately."

Friends of the Earth's GM Campaigner Clare Oxborrow said, "This is an industry out of control. For four years Syngenta failed to notice that they were selling farmers an unapproved GM seed. How are consumers and farmers supposed to trust them to produce our food in the future?

This case makes a complete mockery of the U.S. regulatory system for GM crops. To make matters worse the US government has known about this accident for months and together with Syngenta decided to keep it a secret until now."

Syngenta found out about the mixup from one of its seed manufacturers. The researchers were trying to use engineered maize seeds to breed experimental plants when they discovered the seed was not Bt11.

Syngenta has not said when it was informed of the error. In a statement dated March 21, the company said it "recently discovered" the "unintended event."

The European Commission informed the 25 EU member states without delay via the Rapid Alert System for food and feed. The Commission is asking all member states to stop the entry of Bt10 into their countries and to report any of the unauthorized crop that they detect.

EU Environment Commissioner Stavros Dimas said, “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."

"Member states should also notify the state of play regarding past or current national experimental releases of Bt11, and implement any necessary monitoring and surveillance measures in the surrounding areas where these releases took place,” Dimas said.

Heinz Imhof is chair of the Board of Directors of Syngenta (Photo courtesy IFPRI)

The Commission has also asked Syngenta, the developer of the Bt10 crop, to release the 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.

Syngenta said, "The Bt protein produced by these lines is identical to that produced by the commercialized, fully approved Bt11 varieties. Therefore, there is no change to the food, health and environmental profile of the corn."

The Commission also has asked Syngenta to confirm that all Bt10 plantings and seed stock in the United States have been destroyed or isolated for further destruction. Syngenta has committed to provide that information this week.

The U.S. government has given reassurance that "no food, feed or environmental concerns are associated with the inadvertent release of this nonauthorized 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 U.S. and which the EU has authorized for use in food and feed.

Regulators and the company have been involved in "months of discussions over what should be done about the error, and how and when information should be released to the public," according to an article in the journal "Nature" published March 22.

The issue is particularly sensitive because the United States and the European Union are at odds over whether the new European rules on traceability and labeling of genetically modified crops are required scientifically.

In the United States, three agencies have oversight of transgenic foods. The U.S. Department of Agriculture takes the position that genetically modified crops are safe and do not require special attention.

The U.S. Food and Drug Administration believes that genetically engineered foods are “substantially equivalent” to traditional foods and does not give them special scrutiny.

The U.S. Environmental Protection Agency regulates the pesticide, but not the plant. In the case of corn genetically engineered to produce Bt, the agency regulates the Bt toxin, but the USDA regulates the genetically engineered corn. The EPA does not subject plants that are engineered with traits other than pesticide resistance, such as herbicide tolerance, to environmental review.

The European Union takes the position that environmental risk assessments are needed for each new genetically modified organism before it is marketed to identify and evaluate potential adverse effects.

"These include direct or indirect, immediate or delayed effects, taking into account any cumulative and long term effects on human health and the environment which may arise from the deliberate release or placement on the market," the EU states in its position paper of the regulation of transgenic organisms.

The European environmental risk assessment procedure requires evaluation in terms of how the genetically modified organism was developed and examines the potential risks associated with the new gene products produced by the organism - such as toxic or allergenic proteins - and the possibility of gene-transfer of antibiotic resistance genes.