To approve or not to approve?
The genetically engineered maize varieties "bt11" and "1507"

Situation:

The genetically modified maize varieties "BT 11" (Syngenta) and "1507" (Dupont /Pioneer), which are approved within the EU for use in food and feed but not for cultivation, would be the first GM maize varieties to be approved for cultivation within the European Union since 1998. The European Food Safety Authority EFSA gave a favorable risk assessment for their commercial release into the environment.
However, on October 25 2007 the European Commissioner for the Environment suggested not to approve these varieties for reasons of unclear long term risks such as detrimental effects on butterflies and on soil quality. While the proposal of the Commissioner in charge is usually approved by the college of Commissioners, in this case, due to intensive lobbying of the GM-industry, the Commission might take a different vote and suggest to approve these varieties against the suggestion of Commissioner Stavros Dimas.
Either decision of the Commission would be an important precedence for the future of GMO approvals within the European Union. If Commissioner Dimas prevails, this would be the first time the Commission decides taking into account all concerns, also beyond the narrow and so far always farvorable risk assessment of the GM scientists at EFSA, including precautionary considerations. Should Commissioner Dimas be overruled by his colleagues this would indicate that also in the future other than environmental concerns, such as trade related interests and industry lobby could prevail. It is unclear when exactly the Commission will take its decision (though it will be a Wednesday for sure).

After repeated postponing, the decision is not expected for before March 2008.
According to sources close to the Commission, upon suggestion of the GM industry lobby some pro-GM Commissioners, including Peter Mandelson and Marianne Fischer-Boel, suggest now to send back the dossier to the EFSA to evaluate the new scientific evidence cited by Dimas in defense of the proposed ban. EFSA scientist are, according to these sources, already busy trying to dismiss the scientific studies as "not new".
Commission President Barroso has now suggested to have a more general "orientation debate" of the Commission on GMO issues in late January or early February 2008.

"Save Our Seeds" (as many other interested parties) has obtained copies of the proposed ban of the GM maize varieties. While we cannot publish these officially confidential documents, we may share them with you upon request.

Action:

As the Commissioners are about to take a highly political decision on this issue, it appears appropriate and necessary to remind them about the position most European citizens take on GMOs in food and agriculture. A large majority of citizens has consistently rejected the introduction of GMOs in their food and especially in their environment. A decision of the Commission to overrule Mr Dimas would obviously be a slap in the face of European citizens and put the interests of two agro-industrial multinationals over their concerns and demands.
Friends of the Earth, Greenpeace, SOS, Euro-Coop et al.: Open letter to EU Commission President Barroso

In an An open letter all eight socio-economic organisations of Greece on December 19th demand from the EU Commission not to approve the new bt 11 and 1507 new varieties of GM maize and to orientate EFSA to operate in the interests of European citizens. Greek version of the letter

Nearly 100.000 European Citizens have already expressed their demand to reject the approval of bt11 and 1507 to the European Commissioners. Please join!

What you can do:

For more information contact: Marco Contiero, Senior Policy Adviser on GMOs, Greenpeace European Unit, +32 (0)2 274 1906, Marco.Contiero[at]diala.greenpeace.org

Reaction:

On December 7, Commission Vize President Margot Wallström writes on her weblog:
>>
To all Europeans participating in the Greenpeace cyberaction on GMOs:
I have been told that technical problems prevented many of your messages from reaching email addressees in the European Commission. First, I want to assure you that the concerns you expressed through this activity will be passed on to all Commissioners. I appreciate and welcome the interest you show in our work, and encourage you to continue expressing your concerns directly to us.
You must realise however that if you send us thousands of messages our mailboxes will fill up very quickly!<<

You can post reactions at Mrs. Wallströms blog if you wish.

 

News:

12 Dec 2007: Nature: Showdown for Europe
                & Editorial: Directive action required
"Dimas has misused science to tip the balance of his analysis of risks and benefits with which he justified his decision. [...] The directive needs to be revised to ensure that the checks and balances put in place to reassure opponents, while not crushing innovation, cannot be abused by the political motives of one side."

12. Dec 2007: Germany proposes GM approval overhaul
The German agriculture minister has suggested that the EU make decisions to approve genetically-modified plants in Europe purely on the basis of science and do away with political voting on the matter.

9. Dec 2007, International Herald Tribune: Science and policy collide in EU over genetically modified crops

5. Dec 2007, BioWorld International: European Biotech Industry Goes on GMO Offensive

30. Nov 2007, Le Monde: Du maïs transgénique BT 11, interdit à la culture, a été découvert dans un champ en Bretagne
Illegal planting of BT 11 has been discovered in Britanny, France.

29. Nov 2007, Cordis: European biotech industry criticises Dimas' position on new GM maize types

28. Nov 2007, AP: Greenpeace appeals to EU to reject use of 2 new biotech corn products

26. Nov 2007, Reuters: France and Germany seek to break GMO deadlock
AP: Germany seeks EU biotech review
German Ag-Minister Seehofer calls for a preliminary stop of GMO approvals in Europe
AFP: Seehofer für vorläufigen Stopp der Gen-Zulassungen in Europa

25. Nov 2007, The Independent: Safety fears prompt Europe to consider first ban on GM crop
Sunday Herald, Holyrood bid to ban GM crops in Europe

The Scottish government will this week make an unprecedented intervention in Brussels to try to help ban genetically modified (GM) crops throughout Europe.

23. Nov 2007, New York Times, Proposed Ban on Genetically Modified Corn in Europe

23. Nov 2007, Market Day (UPI), Ban sought on genetically modified corn

21. Nov 2007, International Herald Tribune: EU officials propose ban on genetically modified corn seeds

25. Oct 2007, Reuters: EU environment chief opposes two GMO maizes

25. Oct 2007, FOE / Greenpeace: Dimas calls for GM maize ban in Europe

 

Useful papers and studies

Letters

30 November 2007 letter of the Swedish Organic Farmers Association and Swedish Society for Nature Conservation To Agriculture minister Eskil Erlandsson Environment minister Andreas Carlgren
Sweden did register formal objections to both applications back in 2003-04, on much the same grounds as Dimas is now citing. According to GM staff at the Board of Agriculture, the objections still stand - there has been no shift in the formal position.

Studies

BT 11 MAIZE - C/F/96.05.10, an in depth analysis of the shortcomings of EFSAs risk assessment of BT 11 (Greenpeace, 2005)

1507 - What's wrong with EFSAs assessment? (Friends of the Earth, 2005)
A line by line annotations of the shortcomings of EFSAs risk assessment of maize line 1507
1507 Comments - An analysis and response to EFSAs risk assessment

Too close for comfort: The relationship between the biotech industry and the European Commission (Friends of the Earth 2007)
A detailed analysis of the lobby power of the GMO industry in Brussels and its close ties to the European Commission

Hidden Uncertainties - What the European Commission doesn’t want us to know about the risks of GMOs (Friends of the Earth & Greenpeace, 2006)
An overview on risks pointed out by the European Commission to the WTO in defense of its case against the US

 

Procedure

Once the Commission has adopted a proposal on the approval this is forwarded to the Standing Committee of the Member States. Should the Committee approve the Commissions proposal with a two third majority of votes (distributed among the member states with reference to the number of citizens) the proposal is adopted. Should the Committee fail to agree with a 2/3 majority, the proposal would be submitted to the Council of Ministers. The Council however, can only overrule the Commissions proposal with a two third majority. Should it fail to do so (which has been the case for all new approval decisions so far) the Commission can decide on its own. The Commissions proposal now discussed will therefore determine the final decision unless two thirds of the member states vote against it.

BT 11

Maize line Bt11 was developed through a specific genetic modification to be resistant to attack by European corn borer (ECB; Ostrinia nubilalis), a major insect pest of maize in agriculture. The novel variety produced the insecticidal protein, Cry1Ab, derived from Bacillus thuringiensis subsp. kurstaki (B.t.k.) HD-1 strain. Delta-endotoxins, such as the Cry1Ab protein expressed in Bt11, act by selectively binding to specific sites localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause paralysis and death. Cry1Ab is insecticidal only to lepidopteran insects, and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.Bt11 was also genetically modified to express the pat gene cloned from the common aerobic soil actinomycete, Streptomyces viridochromogenes strain Tu494, which encodes a phosphinothricin-N-acetyltransferase (PAT) enzyme. The PAT enzyme was used as a selectable marker enabling identification of transformed plant cells as well as a source of resistance to the herbicide phosphinothricin (also known as glufosinate ammonium, the active ingredient in the herbicides Basta, Rely, Finale, and Liberty). Glufosinate ammounium acts by inhibiting the plant enzyme glutamine synthetase, the only enzyme in plants that detoxifies ammonia by incorporating it into glutamine. Inhibition of this enzyme leads to an accumulation of ammonia in the plant tissues, which kills the plant within hours of application. PAT catalyses the acetylation of the herbicide phosphinothricin and thus detoxifies glufosinate ammonium into an inactive compound. The modified maize line is protected from ECB and permits farmers to use phosphinothricin-containing herbicides for weed control in the cultivation of maize.
Source and further information: AgBios GM database - BT 11

COMMISSION DECISION of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council.

EFSA Opinion of the Scientific Committee on Food on a request to place genetically modified sweet maize line Bt11 on the market (expressed on 17 April 2002)

BT 11 in the European Unions GMO register (food and feed authoritsation)

1507

Maize line TC1507 was genetically modified to contain two novel genes, cry1Fa2 and pat, for insect resistance and herbicide tolerance respectively. Both genes were introduced into the parental maize hybrid line Hi-II by particle acceleration (biolistic) transformation.
The cry1Fa2 gene, isolated from the common soil bacterium Bacillus thuringiensis (Bt) var. aizawai, produces the insect control protein Cry1F, a delta-endotoxin. Cry proteins, of which Cry1F is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1F is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.
The Cry1F protein expressed in TC1507 provides protection against European corn borer (ECB), southwestern corn borer (SWCB), fall armyworm (FAW), black cutworm (BCW), and some control of corn earworm (CEW).
In addition to the cry1Fa2 gene, TC1507 was developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta®, Rely®, Liberty®, and Finale®), as a weed control option, and as a breeding tool for selecting plants that have the insect-tolerant cry1F gene. Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme's usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.
Glufosinate tolerance in TC1507 maize is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, Streptomyces viridochromogenes, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound.
Source and further information: AgBios GM database - TC 1507

COMMISSION DECISION of 3 March 2006 authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.

EFSA Opinion of the Scientific Panel on Genetically Modified Organisms on an application (reference EFSA-GMO-NL-2004-02) for the placing on the market of insect-tolerant genetically modified maize 1507, for food use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International/Mycogen Seeds, adopted on 19 January 2005

1507 in the European Unions GMO register (food and feed authoritsation)