Approval of New GMOs for cultivation
Situation
The European Commission has proposed to the member states the approval of two new varieties of GM maize for cultivation. The genetically modified maize varieties "BT 11" (Syngenta) and "1507" (Dupont /Pioneer) would be the first GM maize varieties to be approved for cultivation within the European Union since 1998.
This is the latest move in a controversy that has lasted over more than 3 years. On October 25th 2007 the European Commissioner for the Environment, Stavros Dimas, had suggested not to approve these varieties for reasons of unclear long term risks such as detrimental effects on butterflies and on soil quality. This had been the first proposal by an EU Commissioner not to approve a GMO within the European Community. While proposals of the Commissioner in charge are usually approved by the college of Commissioners, in this case, due to intensive lobbying of the GM-industry, the Commission decided to send the proposals back to the EFSA. The agency confirmed its advice for approval in October 2008 and dismissed the additional scientific evidence on the risks involved in bt 11 and 1507. Massive pressure from the cabinet of the Commission president José Manuel Barroso has apparently changed the position of Stavros Dimas.
Whether the new GM varieties will be approved or not depends on the vote of the governments of the 27 EU member states. On February 25 the "Standing Committee on the Food Chain and Animal Health" of member states voted on the proposal with 6 countries (91 votes) in favour, 12 countries (127 votes) against, 7 countries (95 votes) abstaining and two countries (32 votes) not participating. As no qualified majority (255 votes) for either decision was achieved the Council of Ministers will now have to vote on the proposal. Here, a qualified majority against the approval will be required in order to stop the crops from being cultivated.
Key Documents
These are the draft approvals issued by the EU Commission in January 2009, that should be rejected by the Member States:
Draft Commission Decision concerning the placing on the market of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests
Draft Commission Decision concerning the placing on the market of a maize product (Zea mays L., line Bt11) genetically modified for resistance to certain lepidopteran pests
These were the draft bans proposed by the Environment Commissioner in November 2007:
Draft ban of bt11 cultivation
Draft ban of 1507 cultivation
1507 Summary on status of approval for cultivation (with links to key documents)
Bt11 Summary on status of approval for cultivation (with links to key documents)
EFSA opinion on additional scientific evidence on risks of bt 11 and 1507 (EFSA, October 2008)
EFSA’s opinions on Bt11, 1507 and MON810 – Legal and scientific validity (Greenpeace, December 2008)
Short response to EFSA’s review of scientific studies on maize Bt11 and 1507 31st October 2008 (Greenpeace, 31. October 2008)
EFSA initial opinion on cultivation of Bt11, April 2005
Bt 11 MAIZE - an in depth analysis of the shortcomings of EFSAs risk assessment of BT 11 (Greenpeace, 2005)
EFSA initial opinion on cultivation of 1507, June 2005
1507 - What's wrong with EFSAs assessment? (Friends of the Earth, 2005)
Line by line annotations of the shortcomings of EFSA's risk assessment of maize line 1507
1507 Comments - An analysis and response to EFSA's risk assessment
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 and uncertainties of GMOs as pointed out by the European Commission itself (in defense of its case against the US at the WTO in 2005)
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
Jack Heinemann, University of Canterbury, Potential human health risks from Bt plants (2009)
As exposure to Bt-generated Cry toxins has increased dramatically and changed in its nature over the past years and immunological responses to their presence have been observed in mammals including humans suggest a re-evaluation of these toxins impact on human health.
Maize line BT 11
Maize line Bt11 was developed through a specific genetic modification to be resistant to attack by the 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)
Maize line TC 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 the 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)
Papers and studies
Request from the European Commission to review scientific studies related to the impact on the environment of the cultivation of maize Bt11 and 1507 - Scientific opinion of the Panel on Genetically Modified Organisms published 29. October 2008
The GMO Panel concludes that neither the 11 scientific publications selected and provided by the European Commission, nor recent peer-reviewed papers identified as relevant by the GMO Panel, invalidate the former risk assessments of maize Bt11 and 1507 performed by the GMO Panel.
Studies
Scientific Opinion of the Panel on Genetically Modified Organisms on the impact on the environment of the cultivation of maize Bt11 and 1507 published in The EFSA Journal (2008) 851, 1-27.
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
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)
Line by line annotations of the shortcomings of EFSA's risk assessment of maize line 1507
1507 Comments - An analysis and response to EFSA's risk assessment
