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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 5 April 2005
RE: UNAPPROVED GM CORN HAS ANTIBIOTIC-RESISTANCE GENE Further to our mail-out of 28 March 2005, on the inadvertent release of an experimental and unapproved GM corn, we wish to update you further on the issue. Between 2001 and 2004, Syngenta inadvertently produced and distributed an unapproved corn (Bt10). Countries that import corn from the US may have received Bt10. The unapproved Bt10 was mistaken for Bt11, which is approved in some countries. When the news first became public, Jeff Stein, head of regulatory affairs at Syngenta claimed that, "What makes this somewhat unique is that Bt10 and Bt11 are physically identical and the proteins are identical". However, Syngenta now admits that a marker gene that confers resistance to ampicillin, a commonly used antibiotic for treating human and animal infections, is present in Bt10. Bt 11 does not contain an antibiotic-resistance marker gene. The presence of antibiotic-resistance genes raise serious biosafety concerns, as there is a risk that the resistance gene could transfer horizontally to pathogenic microorganisms, potentially compromising the use of the antibiotic in disease treatment. So much so that the EU's 2001/18 Directive on the deliberate release into the environment of genetically modified organisms requires a mandatory phasing out of antibiotic resistance marker genes in GMOs which may have adverse effects on human health and the environment, within specified time frames (31 December 2004 for GMOs placed on the market; 31 December 2008 for deliberate release of GMOs for any other purpose than placing on the market, e.g. field trials). In 2004, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA) issued an Opinion on the use of antibiotic resistance marker genes in GM plants. It recommended that the gene conferring ampicillin resistance should be restricted to field trial purposes and "should not be present in GM plants to be placed on the market". The European Commission on 31 March met with Syngenta representatives, afterwhich it confirmed that up to 10 kg of Bt10 seed may have been exported inadvertently as Bt11 for research purposes to Spain and France, which have since been destroyed. More worryingly, an estimated 1000 metric tonnes of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001. The Commission said that it "deplores the fact that a GMO which has not been authorised through the EU's comprehensive legislative framework for GMOs, nor by any other country, has been imported into the EU." It has written to the US authorities, demanding a guarantee that present and future GM corn exports to the EU do not contain GMOs which are not authorised for the EU market, including Bt10. While the US authorities informed the Commission on 22 March about the inadvertent release of Bt10, they neglected to mention that Bt10 contains the gene conferring resistance against the antibiotic ampicillin. It was only on 31 March that this information was given officially to the Commission by Syngenta. The Commission has asked EU Member States to carry out appropriate control measures to stop Bt10 entering their territory and to implement the necessary monitoring and surveillance measures in the surrounding areas where experimental releases of Bt11 have taken place. It has asked Syngenta to release the full molecular characterisation of Bt10, as well as the specific detection method and adequate reference materials to trace Bt10. As Bt10 is unapproved, countries that have potentially received the GMO would not have conducted the appropriate risk assessments nor would they possess the necessary reference materials to facilitate detection and identification. We urge countries to seek further clarification from Syngenta and the US authorities so that appropriate action can be taken. It is of concern that 4 years have passed before the inadvertent release of experimental and unapproved Bt10 has come to public knowledge; moreover Bt10 contains an antibiotic-resistance gene. This incident highlights the difficulties involved in controlling and monitoring GMOs. We attach below an article from Nature and the statement from the European Commission. With best wishes,
Item 1 Hundreds of tonnes of genetically modified corn seeds sold to farmers by mistake over the past four years contained a gene for antibiotic resistance, Nature has learned. The release of such genes into the environment is sometimes considered inadvisable, as there is a small chance that they could flow from crops to microorganisms and spread problems of antibiotic resistance. The Swiss biotechnology company Syngenta admitted last week that it had accidentally released a variety of corn (maize) called Bt10 between 2001 and 2004. Like other crops with the name Bt, this corn had been genetically modified to produce a protective pesticide. But Bt10 has not been approved for sale by regulatory agencies. Officials at the company last week argued that Bt10 is basically identical to Bt11 corn, which has been approved for sale (see Nature 434, 423; 2005). But this week, Sarah Hull, a spokeswoman for Syngenta, confirmed that a marker gene that confers resistance to ampicillin, a commonly used antibiotic, was present in the Bt10 seeds. She adds that this gene would not have been active in the corn plants that grew from the seeds. Antibiotic-resistance genes are widely used as 'tags' during the production of genetically modified crops, to help breeders identify and preserve desirable strains. But the genes are often removed before the seeds enter the food chain. The presence of the marker gene in Bt10 corn was noted in a 2003 advice notice from a UK government committee, the Advisory Committee on Releases to the Environment, which was using Bt10 as a comparison to prove that there were no marker genes in Bt11 corn. Critics have expressed surprise that neither Syngenta nor the US Environmental Protection Agency (EPA) announced the presence of the marker when they admitted that the release of Bt10 had taken place. "It is quite scandalous," says Greg Jaffe, head of the biotechnology project at the Center for Science in the Public Interest, a pressure group in Washington DC. "This shows that the government and the company are not being forthright." Hull says that the company didn't mention the gene's presence because "it wasn't relevant to the health and safety discussion". She adds that the antibiotic-resistance genes have been around for a long time. "They've been studied extensively, and they pose no risk to humans or animals," she says. Regulators say that the genes present a very small risk to human health, either directly - if in the stomach of a patient on antibiotics, for example - or indirectly through gene flow into microbes. Michael Rodemeyer, director of the Pew Initiative on Food and Biotechnology, a think-tank in Washington DC, says that the presence of such genes would be unlikely to see a crop declared unsafe in the United States - but adds that it could cause problems in Europe. In a ruling published last April, for example, the European Food Safety Authority, which advises European Union governments on food issues, said that marker genes conferring resistance to ampicillin "should be restricted to field trials and not be present in genetically modified plants placed on the market". And the Codex Alimentarius Commission, the international food-standards body, has urged the agricultural biotechnology industry to use alternative methods to refine genetically modified strains in the future. The EPA, which is jointly investigating the release of the Bt10 corn with the US Department of Agriculture, declined to say what it knew about the antibiotic-resistance marker. "What the company told us and when about the marker gene is part of our ongoing investigation and we are not able to discuss it at this time," the agency said in a statement. "I think they've done a terrible job," says Margaret Mellon, head of the food and environment programme at the Union of Concerned Scientists in Washington DC, referring to both Syngenta and the government agencies. "There are lots and lots of unanswered questions, and the longer they remain, the less confidence people are going to have in the technology and in the regulatory system."
The European Commission has written to the US authorities and to the biotechnology company Syngenta requesting clarification of the situation regarding the unauthorised genetically modified maize Bt10. According to the information received to date from the US authorities and from Syngenta, the developer of Bt10, up to 10 kg 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 is informed that an estimated 1000 metric tonnes of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001, the date from which the inadvertent release of Bt10 started. At a meeting yesterday with representatives of Syngenta, officials of the European Commission were informed that Bt10 included the gene conferring resistance to the antibiotic ampicillin. EU Health and Consumer Protection Commissoner Markos Kyprianou said: "The European Commission deplores the fact that a GMO which has not been authorised through the EU's comprehensive legislative framework for GMOs, nor by any other country, has been imported into the EU, and we are writing to the US authorities asking them to guarantee, by taking the appropriate measures, that present and future exports of maize to the EU do not contain GMOs which are not authorised for the EU market, including Bt10. This case again shows the importance of the European Unions's comprehensive framework for traceability and labelling of GMOs." 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." The Commission was first informed by the US Mission to the European Union on 22 March about an inadvertent release in the US of a non authorised genetically modified maize line called Bt10. The Commission informed the Member States without delay via the Rapid Alert System for food and feed. Moreover, the Commission has asked the US Administration for the full safety information about Bt10 at its disposal without delay, including the full risk assessments upon which it is based as well as for an urgent audit and an official view as to the quantities exported, including the channels they may have taken in the EU. The Commission has also asked Syngenta, the developer of the Bt10 crop, to release the full information about the molecular characterisation of Bt10 and its distinction from Bt11, as well as the specific detection method and adequate reference materials to trace Bt10. The Commission has also asked Syngenta to confirm that all Bt10 plantings and seed stock in the USA have been destroyed or isolated for further destruction. Syngenta has committed to provide this information next week. The US government has given reassurance that no food, feed or environmental concerns are associated with the inadvertent release of this non authorised genetically modified crop, based on the fact that the Bt protein in Bt10 is similar to the one in Bt11, which is fully authorised in the US and which the EU has authorised for use in food and feed. However, the US authorities did not inform the Commission that Bt10 contains, contrary to Bt11, the gene conferring resistance against the antibiotic ampicillin. It was only on the 31 of March 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. However, according to Syngenta, this gene is inactive in Bt10.
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