Here's a very precise account of the measures the EU has adopted for dealing with Syngenta's rogue Bt10 maize, including the draft Decision of the European Commission that was approved by EU member states.
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EUROPE ADOPTS EMERGENCY MEASURES FOR UNAPPROVED BT10 FROM THE U.S. [1]
THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
19 April 2005

Dear friends and colleagues,

RE: EUROPE ADOPTS EMERGENCY MEASURES FOR UNAPPROVED BT10 FROM THE U.S. [1]

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 unauthorized 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 GMOs. The unapproved Bt10 was mistaken for Bt11, which is approved in some countries.

Between 2001 and 2004, Syngenta had inadvertently produced and distributed Bt10 (see BIS 5 April 2004). An estimated 1000 metric tonnes of Bt10 products may have entered the EU through Bt11 export channels since 2001. Other countries that import corn from the US may also have received Bt10.

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 (see BIS 28 March 2005).

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.

EU member states voted almost unanimously to adopt the draft decision. 22 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 demonstrates 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.

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 characterization of Bt10 and its distinction from Bt11, as well as the specific detection method to trace Bt10.

The EU recognizes that the measures should be "no more restrictive of trade than is required", and thus limits the conditions only to corn feed and brewers grains 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 WTO rules.

We urge countries that may have potentially received Bt10 to require similar assurances that their corn imports from the US are free from Bt10.

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 to verify results.

In any case, the Bt10 incident highlights the urgent need for international norms to require 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 also be in place 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.

We attach below the draft Decision of the European Commission that was approved by EU member states with slight amendments. Relevant press articles related to the decision will be sent in a separate mail-out.

With best wishes,

Lim Li Ching
Third World Network
121-S Jalan Utama
10450 Penang
Malaysia
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: www.twnside.org.sg


REF: Doc.TWN/Biosafety/2005/J

Draft
COMMISSION DECISION../
/EC
of []
on emergency measures regarding the non authorised genetically modified organism "Bt10" in maize products
(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety , and in particular Article 53(1) thereof,
Whereas:
(1) Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 on genetically modified (GM) food and feed provide that no genetically modified food or feed shall be placed on the Community market unless it is covered by an authorisation granted in accordance with that Regulation. Articles 4(3) and 16(3) of the same Regulation lay down that no GM food and feed shall be authorised unless it has been adequately and sufficiently demonstrated that it does not have adverse effects on human health, animal health or the environment, that it does not mislead the consumer or the user, and differ from the food or feed it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals.
(2) On 22 March 2004, the authorities of the United States of America (the US authorities) informed the Commission that maize products contaminated with the genetically modified organism called "Bt10" (the contaminated products), which have not been authorised for placing on the market in the Community, were likely to have been exported to the Community since 2001 and to continue to be exported. In addition, these authorities informed the Commission that those products were not authorised for placing on the market in the United States of America either.
(3) Without prejudice to the control obligations of the Member States, the measures to be adopted further to the likely imports of contaminated products should be subject to a comprehensive and common approach allowing rapid and effective action to be taken and avoiding disparities between Member States in the treatment of the situation.
(4) Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Community emergency measures for food and feed imported from a third country in order to protect human health, animal health or the environment, where the risk can not be contained satisfactorily by means of measures taken by the Member States concerned.
(5) Although the contamination of products was reported by Syngenta, which is the company developing the genetically modified maize "Bt10", to the US authorities in December 2004, no data enabling a safety assessment of the genetically modified maize "Bt10" by the European Food Safety Authority (the Authority) according to the standards laid down in Regulation (EC) No 1829/2003 were provided by Syngenta or the US authorities. According to the Authority , in the absence of this information, the safety of "Bt10" has yet to be confirmed.
(6) Considering the absence of sufficient data enabling a safety assessment of the genetically modified maize "Bt10" in order to achieve the high level of health protection chosen in the Community, and the presumption of risk on products not authorised according to Regulation (EC) No 1829/2003, which takes into account the precautionary principle laid down in Article 7 of Regulation (EC) No 178/2002, it is appropriate to take emergency measures in order to prevent the placing on the market in the Community of the contaminated products.
(7) According to the general requirements laid down in Regulation (EC) No 178/2002, food and feed business operators have primary legal responsibility for ensuring that foods or feeds within the businesses under their control satisfy the requirements of food law and for verifying that such requirements are met. The duty to prove the absence of placing on the market of the contaminated products should therefore rely on the responsible operator. To this end, the emergency measures should require that consignments of specific products originating from the United States of America may be placed on the market only if an analytical report proving that the products are not contaminated with the genetically modified maize "Bt10" is provided. The analytical report should be issued by an accredited laboratory according to internationally recognised standards.
(8) In order to facilitate controls, all genetically modified food and feed placed on the market should be subject to a validated method of detection. Syngenta has been requested to provide the method for the event-specific detection of the genetically modified maize "Bt10" as well as control samples. Consequently, the Community reference laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 (the CRL) has been asked to test the detection method for this product on the basis of data provided by Syngenta. The detection method is made available by Syngenta and can also be found at the following address: http://gmo-crl.jrc.it
(9) Considering that the measures provided for in this Decision must be proportionate and no more restrictive of trade than is required, only products considered as the most likely contaminated with genetically modified maize "Bt10" should be covered. According to the information received from the US authorities, neither genetically modified maize grain nor any product derived therefrom are imported from the United States of America to the Community, with the exception of corn gluten feed and brewers grains for feed use. Accordingly, the latter products should be the subject of the said measures.
(10) Despite requests made by the Commission, the US authorities were not in a position to provide any guarantee on the absence of "Bt10" in corn gluten feed and brewers grains containing or produced from genetically modified organisms, which are imported in the Community, considering the lack of segregation or traceability measures in the United States of America on these products.
(11) With regard to food products, according to the information made available to the Commission, no genetically modified maize imported from the United States of America is used in the production of food in the Community. Member States should however monitor whether genetically modified maize food products are present on the market and whether these have been contaminated by "Bt10". On the basis of the information provided by Member States, the Commission will consider the need of any appropriate measure.
(12) These measures should be evaluated at the latest after 6 months in order to assess whether they are still necessary.
(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1
Scope
This Decision applies to the following products originating from the United States of America:
- corn gluten feed containing or produced from genetically modified maize within CN code 2309 9020
- brewers grains containing or produced from genetically modified maize within CN code 2303 3000.
Article 2
Conditions for first placing on the market
1. Member States shall allow the first placing on the market of the products referred to in Article 1 only where an original analytical report issued by an accredited laboratory accompanying the consignment proves that the product does not contain "Bt10" maize or feed produced from "Bt10" maize.
2. In the absence of such an analytical report, the operator established in the Community who is responsible for the first placing on the market of the product shall have the products referred to in Article 1 tested to prove that they do not contain "Bt10" maize or feed produced from "Bt10" maize. Pending availability of the analytical report, the consignment shall not be placed on the market of the Community.
3. Member States shall inform the Commission of positive (unfavourable) results through the Rapid Alert System for food and feed.
Article 3
Other control measures
Member States shall take appropriate measures, including random sampling and analysis, of the products referred to in Article 1 already on the market in order to verify the absence of "Bt10" maize or feed produced from "Bt10" maize. They shall inform the Commission of positive (unfavourable) results through the Rapid Alert System for food and feed.
Article 4
Contaminated consignments
Member States shall take the necessary measures to ensure that the products referred to in Article 1 that are found to contain "Bt10" maize or feed produced from "Bt10" maize are not placed on the market.
Article 5
Recovery of costs
Member States shall ensure that the costs incurred in the implementation of Articles 2 and 4 are borne by the operators concerned.
Article 6
Addressees
This Decision is addressed to the Member States.
Done at Brussels,
For the Commission
Markos Kyprianou
Member of the Commission