Battle of the bio-tech tuber

The European Commission is deeply divided over a proposal to approve a genetically modified (GM) strain of potato named ‘Amflora’ engineered by the German chemical giant BASF to produce high quantities of starch for industrial purposes.

If approved, it would be the first authorisation for cultivation of a GM crop in the EU since a de facto moratorium on new GM products was imposed in November 1998. It is also the last GM product, among those that are in line for a green light from the EU, to carry an antibiotic resistance marker (ARM) gene, which is a controversial and increasingly obsolete construction.

EU member states in July could not reach a qualified majority either to approve or reject the proposal, so it reverts to the Commission to decide. Three weeks ago, Stavros Dimas, the environment commissioner, came out firmly against the approval, arguing that risks for both health and the environment could not be ruled out and that new studies were required.

Other commissioners - in particular Peter Mandelson (trade), Günter Verheugen (industry) and Janez Potocˇnik (research) are pushing for approval, claiming that failure to approve any GM crops could soon trigger an international legal action against the EU. Some years ago the US, Canada and Argentina complained to the World Trade Organization (WTO) against the EU’s de facto moratorium. In 2004 the Commission lost the case. But in the meantime the EU restarted the procedures to approve GM products, after the entry into force of new and stricter rules for GM food and animal feed (Regulation EC 1829/2003). The Commission, considering that the de facto moratorium had already been removed, interpreted the WTO ruling as having just a retrospective effect, with no bearing on the current situation. But since then, no new GM crop has been authorised for cultivation, which has led to growing discontent in the biotech industry. Five months ago, for example, Pioneer Hi-Bred International filed a lawsuit against the Commission for delaying the approval of its transgenic maize variety 1507.

The Commission of José Manuel Barroso was on the verge of yielding to the pressure, allowing some cultivation of GM crops, but possibly limited to industrial use, since public opinion and consumers are generally much more suspicious about GM products in food. But there are reasons for thinking that the Amflora potato is the wrong candidate to introduce a change of policy.

Last Wednesday (10 October) experts from the member states on the EU’s Standing Committee on the Food Chain and Animal Health failed, once again, to reach a qualified majority in favour or against another proposal to authorise the BASF potato, this time for its use in animal feed. This parallel procedure also concerns the possible contamination of the food chain, which would be tolerated up to a 0.9% threshold, as for all the food and animal feed based on GM crops which are legally approved in the EU. That makes it harder to argue, as the Commission was claiming up until three months ago, that Amflora should be considered as a non-food GM crop only intended for industrial use.

Another, arguably greater, problem is the presence in the BASF potato of the ‘marker’ gene called nptII, which confers resistance to the antibiotic kanamycin. Marker genes of this kind serve no agronomic purpose: they are useful only in the research and development phase (to verify that the genetic modification has been successful) and could well be removed from the GM products before commercialisation. Scientists and research centres working in the field, such as the Institut Pasteur, are increasingly concerned by the spreading of antibiotic resistance in pathogenic bacteria and fear that this phenomenon could be increased for futile purposes. Furthermore, alternative markers, less problematic than ARM genes, have been technically available for years.

There is also a legal question about the use of ARM genes. Article four of the relevant legislation for GMs to be placed on the market (Directive EC 2001/18) states that marker genes expressing resistance to antibiotics for medical or veterinary treatment purposes, which may have adverse effects on human health and the environment, should be phased out by the end of 2004. So, why is the Commission contemplating the approval of the Amflora potato, risking a violation of the directive? The EU executive is being guided by the European Food Safety Authority (EFSA) - the EU agency with the statutory role to assess the risk of GMs before their political approval - which has ruled in favour of it. Yet the assessment given by EFSA on the marker gene used in the BASF potato has proven very controversial. The World Health Organisation and the European Medicines Agency have contradicted the EFSA statement according to which kanamycin (the antibiotic that the BASF potato is resistant to) should be considered as an antibacterial of minor clinical importance. Both organisations ruled, instead, that kanamycin is crucial for human medicine.

Another point of controversy is whether the Commission should base its decisions on GMs strictly on the basis of the EFSA’s advice - as it has been doing for years. Some argue that its role as the EU risk manager obliges it to take on board considerations beyond the strictly scientific arguments put forward by EFSA. The director of EFSA, Catherine Geslain-Lanéelle, speaking in Brussels on 9 October after a hearing in the European Parliament, said: "Our responsibility is to give our scientific advice to the Commission, not to tell them what to do." The Commission’s decisions, she added, "must be science-based, but science is only one of the factors to take into account". She added: "The Commission has its responsibility as EU risk manager, which is to consider also socio-economic, political and ethical aspects, including perception and acceptance by the public. The Commission does not have to say ‘yes’ just because we have said ‘yes’."

EFSA and the marker genes

In a 2004 opinion on the use of antibiotic resistance marker (ARM) genes in genetically modified (GM) crops, the European Food Safety Authority (EFSA) classified these particular ‘markers’ in three categories, according to the clinical importance of the relevant antibiotics.

The first group was AMR genes resistant to antibiotics "which have no or only minor therapeutic relevance in human medicine and only restricted use in defined areas of veterinary medicine".

The second group included genes "widely distributed in micro-organisms in the environment (soil, plant, water and the mammal gut)" and conferring resistance to antibiotics that are "used for therapy in defined areas of human and veterinary medicine". The third group, was "antibiotic resistance genes which confer resistance to antibiotics highly relevant for human therapy".

The opinion was drafted at the request of the European Commission to implement the phasing out of ARM genes required by the relevant EU legislation.

In its conclusions, EFSA advised the Commission not to approve any GM crop containing ARM genes of the third group. "Irrespective of considerations about the realistic value of the threat," it argued, "[they] should be avoided in the genome of transgenic plants to ensure the highest standard of preventive health care."

EFSA also suggested limiting approvals only to experimental trials - excluding cultivation for commercial purposes - for GM crops falling in the second category.

According to EFSA, only ARM genes of the first group could fully escape the phasing out regime envisaged in the directive.

The controversy over the BASF potato has been stoked by differences on the risk posed by ARM genes, conferring resistance to the kanamycin antibiotic, such as the nptII gene in the Amflora potato. Opinions from the World Health Organisation and the European Medicines Agency should not, say anti-GM product campaigners, allow kanamycin to be considered of "no or only minor therapeutic relevance". Genes resistant to this antibiotic should correspond to the EFSA definition for AMR genes of the third group, they argue, and so not be allowed in the EU, "irrespective of consideration about the realistic value of the threat".

• Lorenzo Consoli is Brussels correspondent of Apcom.

The European Commission is deeply divided over a proposal to approve a genetically modified (GM) strain of potato named ‘Amflora’ engineered by the German chemical giant BASF to produce high quantities of starch for industrial purposes.