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GMW: EXCELLENT SUMMARY OF EU'S EMERGENCY MEASURES FOR ROGUE MAIZE

" GM WATCH " <info

Wed, 20 Apr 2005 09:39:33 +0100

 

 

 

(Where is the US response to it getting into the US food supply?

As most was probably released in the US, but not even anything about

this in any major US media outlet?????)

 

 

 

GM WATCH daily

http://www.gmwatch.org

------

 

 

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.

------

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: twnet

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

 

 

 

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