European Biotechnology News, July 15 2009 
The cultivation of genetically modified organisms (GMOs) in the European Union could soon no longer be decided by scientific facts, but by political preferences. Fourteen member states – among them France, Poland and Portugal – say each of the 27 nations of the EU should be allowed to decide independently of scientific risk assessments whether or not to allow GMO cultivation on their territory. At the end of June, Austria tabled a proposal at the Environment Council in Luxembourg to establish this kind of politically motivated opt-out clause.

Many scientists and some GMO-friendly governments say the proposal would provide a “more honest” solution than the current safeguard clause, which only allows opting out if there is documented scientific evidence for GMO-related damage or danger. Industry representatives, however, were less than enthusiastic.

"There are already regulatory options in place today to prohibit GMOs at the national level,” EuropaBio's GMO expert Nathalie Moll told EuroBiotechNews. “Every approach that is aimed at modifying the existing EU legislation will prolong the current GMO de facto moratorium, and will further delay authorisation of products that have been assessed as safe for human health and the environment. Furthermore, the proposal goes against the idea of a free market. Therefore we should take a look at other available options without changing legislation.”

The Austrian proposal – which has already been signed by Austria, Bulgaria, Cyprus, Greece, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia and the Netherlands, and is backed by France, Poland, Portugal, and parts of the German government – argues differently: “Given the unsatisfactory situation and the negative attitude towards GMOs in large parts of the population in many member states, the time has come to find a new approach to deal with the authorisation and use of GMOs in agriculture,” it states. “The soundest legal solution we can envisage is a set of minor amendments of relevant EU legislation, which should introduce the right of an individual member state to restrict or prohibit indefinitely the cultivation of authorised GMOs on its territory.”

Dr. Michel Haas from the Austrian Health Ministry, who helped draft the proposal, told EuroBiotechNews that "we had an informal talk about the sort of amendments we are thinking of with the Commission, and we expect the Commission will deal with our proposals.” The amendments, which apply to Directive 2001/18/EC, Regulation 1829/2003 and consequently affect Directives 2002/53/EC and 2002/55/EC, are based on the subsidiarity principle (Article 5 TEC) and the priniciple of unanimity on land use (Art. 175 TEC). “My impression is that we’ll have to wait for the next Commission to push the discussion forwards,” said Haas.

Vast majority behind Austria?

But even the current Commission has seemingly changed its GMO policy drastically after being mauled in the EU Council in March when it tried to lift national GMO bans in Austria and Hungary (see EuroBio techNews 3-4/2009). A few days before the Council meeting, Karl Falkenberg, the most high ranking EU officer to work for Environment Commissioner Stavros Dimas, confirmed the policy change, stating that the Commission will not approve any GMO against the will of the EU Council in the near future.

A GMO-sceptic himself, Dimas also announced he will ask all member states to give their input on socio-economic criteria that would allow EU member states to opt out of GMO cultivation. “We hope that an appropriate report due to be published by June 2010 will be tabled much earlier,” said Haas.
“Nobody argued against our proposal,” said Austrian Environment Minister Nikolaus Berlakovich after the Council meeting. However, the GMO-friendly member states seem to be as yet divided over the proposal. Whilst Czech Environment Minister Ladislav Miko said his country had always respected the individual right of any member state to decide over GMO cultivation on its own, Spain seemed to be more noncommittal, according to Haas.

Strong support from scientists and NGOs

The Austrian move received surprise support from NGO groups that are usually fundamentally opposed to any release of GMOs into the environment, as well as from renowned scientists. “The aim of the initiative must be to retain the normal approval procedure, but to add the possibility for critical member states to ban GMO cultivation,” Phillipp Strom from Greenpeace Austria told EuroBiotechNews, adding that the right to national GMO bans would be great progress.

“The question is – how we can stop the never-ending cycle? A member state invokes the safeguard clause with pseudo-scientific arguments – the EFSA rejects the arguments – the Commission proposes lifting the GMO ban in the member state – and the Council rejects the Commission’s proposal,” said Prof. Jürgen Schiemann, current chair of the International Society for Bio safety Research (ISBR). “Why not establish a Europe of different velocities concerning GMO cultivation, in which some member states will cultivate GMOs and some will not?” the GMO expert told EuroBiotechNews. “I’m not a lawyer, but I don’t think the WTO would be able to argue against a solution where products made from GMOs can be imported into EU markets while GMO approvals are no longer blocked,” said the former member of the GMO panel of the European Food Safety Authority (EFSA). “And most importantly, an individual opt-out clause could end the misuse of science and scientific assessments for politically-motiva ted decisions.”

In contrast, reactions from the industry were less convinced. “Making the issue a national one would lead to inequalities in competitiveness for farmers, to trade barriers, and to fragmentation of the internal market,” said Dr. Ricardo Gent, Executive Director of German biotech association DIB. “The Commission has neither stated what it thinks of the proposal, nor is it clear if its ideas are in line with existing national and EU legislation,” he said. “I’m not sure if the proposed nationalisation concerning GMO cultivation would change the voting behaviour of the member states in the Council or the competent Committee when it comes to GMO market authorisation,” added Moll from EuropaBio. But if it did, a Europe of multitrack GMO velocities could help take the pressure off scientists and governments, according to Schiemann. For the companies that have put a lot of money into product development however, that could prove a less than satisfying solution.

Three safe GMOs now waiting for EU cultivation permission

A week before Austria’s move, BASF board member Dr. Stefan Marcinoswski believed all was right with the world. The EFSA had just confirmed its two previous assessments (from 2003 and 2007) on the safety of the antibiotic resistance marker gene npt2, used in BASF’s GM potato Amflora, which has been waiting for EU market approval since 1996. The authority’s GMO and Biohaz panels had confirmed that npt2 gene transfer by homologous recombination to soil bacteria, which might pass along kanamycin resistance to human patho gens, has never been observed either in nature or the lab, which makes the transfer of an antibiotic resistance phenotype improbable.

“Today’s assessment gives the entire European Commission the final scientific clarity to approve Amflora,” said Marcinowski on the day the EFSA statement was published. “I am pleased, since the Commission stated in May 2008 that it will approve Amflora if and when EFSA has confirmed the safety of the product.”

At the end of June, the Parma-based EU authority had confirmed that two genetically engineered maize lines (NK603 and Mon810) filed for market re-authorisation by US agribiotech giant Monsanto are safe for human health and the environment.

As with BASF’s amylopectin-producing GM potato, the path should now theoretically be free for cultivation of NK603 and Mon810 throughout all 27 EU member states. But officially, the Commission has yet to come to a decision concerning Amflora et al, and Commission president Jose Manuel Barroso, who is currently seeking support for re-election, seems unwilling to go ahead with GMO market authorisations without a solution backed by a majority of member states. BASF has already sent a letter to the Commission reminding it of last year’s promise. “If the system depends on political preferences instead of science, it could quickly become fragile,” says a BASF spokesman.