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[SANET-MG] Bt10 emergency measures
It is disturbing that Syngenta and USDA/APHIS have continued to
stonewall requests for simple basic information on the molecular make-up
of the contaminating Bt10 insert. Clearly, they are likely to be
concealing something very damning. It is likely that a team of morons
from the State department will make obscene threats about countries that
refuse to gobble their contaminated maize.
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. 
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
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
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
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
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,
(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:
(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
(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:
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.
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.
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.
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.
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.
This Decision is addressed to the Member States.
Done at Brussels,
For the Commission
Member of the Commission
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