Europe adopts emergency measures to prevent entry of unapproved GE corn

Europe adopts emergency measures to prevent entry of unapproved GE corn

Europe has now taken emergency remedial measures to prevent the import of unapproved and experimental genetically engineered Bt10 corn, after Syngenta inadvertently released Bt10 between 2001 and 2004.

Lim Li Ching

EUROPEAN Union member states voted, on 15 April, to restrict US shipments of suspect corn imports unless it was assured that the shipments are free of the experimental and unauthorised genetically engineered (GE) corn, Bt10. Imports of corn products which are certified as free of Bt10 will be allowed.

The EU, like many countries around the world, has zero tolerance for unapproved genetically modified organisms (GMOs). The unapproved Bt10 was mistaken for Bt11, which is approved in some countries.

GE multinational corporation Syngenta had, between 2001 and 2004, ‘inadvertently’ produced and distributed Bt10.

On 31 March the EU’s executive European Commission confirmed that up to 10 kg of Bt10 seeds may have been exported accidentally as Bt11 for research purposes to Spain and France, which have since been destroyed. Furthermore, an estimated 1,000 metric tons of Bt10 food and feed products may have entered the EU through the Bt11 export channels since 2001. Other countries that import corn from the US may also have received Bt10.

The European Commission said then 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’.

Emergency measures necessary

The EU’s Standing Committee on the Food Chain and Animal Health considered a draft European Commission decision which introduced legally binding emergency measures that require imports of corn gluten feed and brewers’ grain from the US to be certified as free of Bt10. These are the imported products considered most likely to be contaminated with Bt10.

EU member states voted almost unanimously to adopt the draft decision. Twenty two of the 25 EU countries voted in favour, while Hungary abstained, and Lithuania and Malta were not present at the meeting.

Consignments of corn gluten feed and brewers’ grain from the US can now only be placed on the EU market if they are accompanied by an original analytical report issued by an accredited laboratory which states that the product does not contain Bt10. In the absence of such a report, the importing company must either have the corn tested or not place it on the market.

Complying with the WTO

The EU said that given the failure of Syngenta or the US authorities to deliver the data necessary for a full safety assessment of Bt10, such ’emergency measures’ are required ‘in order to achieve the high level of health protection chosen in the Community’.
The measures also call on EU member states to conduct spot checks of their GE corn imports, a process that is waiting on Syngenta’s release of the full information about the molecular characterisation of Bt10 and its distinction from Bt11, as well as the specific detection method to trace Bt10.

The EU recognises that the measures should be ‘no more restrictive of trade than is required’, and thus limits the conditions only to corn feed and brewers’ grain, given that the US has provided assurances that apart from those products, neither GE corn grain nor any product derived from this are imported into the EU from the US. Furthermore, no GE corn imported from the US is used in the production of food in the EU. Making the measures no more trade-restrictive than required ensures compliance with World Trade Organisation (WTO) rules.

The measures will be reviewed at the end of October. As soon as the measures were announced, all imports of US corn animal feed were reportedly stopped at British ports and supplies in transit were being tested at the ports.

On 22 April 2005, Sygenta presented a detection test for Bt10, which was validated by EU authorities.
US exporters send 3.5 million tons of corn gluten feed to EU countries each year, a trade that is worth some 350 million euros (US$449 million).

Japan reacts

Another major importer of US corn, Japan, has also put in place rules that would require importers to destroy US corn shipments or ship them back to the US if they are contaminated with the unapproved Bt10. Japan imports 14 to 16 million metric tons of corn annually, 90% of that sourced from the US.

The Japanese Health Ministry has announced that inspection offices at Japan’s ports will start testing samples of corn cargoes from the US to determine whether they contain Bt10. It is unclear if Japan possesses the detection methods for Bt10 testing.
Japanese importers have also nearly stopped making new purchases of US corn due to fears that shipments might contain Bt10. Some Japanese purchasers have reportedly shifted to non-US sources for their corn, especially for the food market.

Four years too late

It was on 22 March that the science journal Nature broke the story that Syngenta had inadvertently produced and distributed Bt10.

About 14,000 bags of Bt10 seeds, or enough to plant 37,000 acres, were sold from 2001 to 2004, mainly to farmers in the US, but also in Canada and Argentina. Farmers could have produced an estimated 150,000 tons of corn from this area.
The delay in making the release known – almost four months since the US government entered into talks with Syngenta in December 2004 and after four years of trade – is particularly troubling.
It is of concern that four years passed before the inadvertent release of experimental and
unapproved Bt10 was even picked up by Syngenta. This incident highlights the difficulties involved in controlling and monitoring GMOs.

As Bt10 is unapproved, countries that have potentially received it would not have conducted the appropriate risk assessments nor would they possess the necessary reference materials to facilitate detection and identification.

Furthermore, while the US authorities informed the European Commission on 22 March about the inadvertent release of Bt10, they neglected to mention that Bt10 actually 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.

Bt10 has antibiotic resistance marker gene

The unapproved Bt10 was apparently mistaken for Bt11, which is approved in some countries. When the news of the mix-up first became public, Jeff Stein, head of regulatory affairs at Syngenta, claimed, ‘What makes this somewhat unique is that Bt10 and Bt11 are physically identical and the proteins are identical.’

However, Syngenta later admitted that a marker gene that confers resistance to ampicillin, a commonly used antibiotic for treating human and animal infections, is present in Bt10. Bt11 does not contain an antibiotic resistance marker gene.
The presence of an antibiotic resistance gene raises 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 GMOs 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 issued an Opinion on the use of antibiotic resistance marker genes in GE 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’.

Segregation, detection, identification and traceability

The EU’s emergency measures to stop Bt10 from entering EU member states are necessary to prevent an experimental and unapproved (hence, illegal) GMO from posing public health and environmental risks.

Currently, in the absence of the Bt10-free certification, the importing company in the EU will have to either test the shipment or not place it on the market. For many developing countries, it will be difficult and costly to test incoming shipments from the US.

By requiring the exporter to provide a report issued by an accredited laboratory showing that a shipment does not contain Bt10, this ensures that the burden of proof falls on the exporter. In addition, countries should insist that Syngenta sets up a compensation fund to pay for the testing of corn products worldwide. Testing may still be necessary on the importing country side’s to verify results.

In any case, the international norm should be for segregation and testing of GE commodities before export, by GE producers and exporters, in order to ensure that GE-free shipments are maintained and that any unapproved GMOs are detected before shipment, to avoid disruption to trade.

A clear system for traceability must be in place in order to ensure monitoring and surveillance and to enable product recalls of an unapproved GMO, if necessary. Detection methods and the necessary reference materials should be provided by GE developers, including for experimental GMOs, to enable detection and identification.

Segregation would also facilitate clear, unambiguous and detailed identification of GMOs in accompanying shipping documents, as desired by most importing countries. These issues are currently discussed under Article 18.2(a) of the Cartagena Protocol on Biosafety, but are contentious because GE producing and exporting countries simply want the documents to state that the shipment ‘may contain’ LMOs (living modified organisms, a term used in the Protocol).

Such ambiguous identification standards will not require segregation and thus will not help at all in case another unapproved GMO enters export channels. Clear identification, including documents that state that a shipment contains GMOs, and full information about its identity, including common, scientific and commercial names, transformation event codes and any unique identifier codes, means that the burden to segregate and test GMOs will fall on the exporter, not importing countries, and that any unapproved GMO would more likely be detected before export.

Meanwhile, under a settlement reached with the US Department of Agriculture (USDA) and the Environmental Protection Agency, Syngenta has been fined US$375,000 (270,000 euros) for the incident. The USDA also required Syngenta to develop a training programme to keep the mix-up in seeds from happening again and teach its employees ‘the importance of complying with all rules’.

To those concerned about biosafety and possible contamination by Bt10 in corn fields, this settlement certainly seems like just a slight slap on the wrist.

Lim Li Ching is a researcher with the Third World Network.

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