Industry still fears political opposition to European Union GM legislation

The European Parliament's mid-April vote on revisions to the European directive 90/220 for release of genetically modified (GM) organisms into the environment was broadly welcomed by companies and industry groups as having rejected some of the more extreme antibiotechnology proposals. For instance, an amendment that attempted to ban gene flow was rejected because the Parliament recognized it as a natural phenomenon. However, industry concerns about the effects of entrenched national political position in blocking future progress remain.

The parliamentary vote means that the legislation now has to go through a conciliation process to resolve differences in the texts proposed by the European Council of Ministers (representing the member nations of the European Union, EU) and the European Parliament. There are several areas of dispute: Parliament voted to exclude pharmaceutical products from the new directive, but the European Commission wants them in; Parliament had incorporated several provisions on import/export certification from the UN Biosafety Protocol into the directive that Environment Commissioner Margot Wallström thinks are inappropriate. The Commission also rejected various other parts of the Parliament's proposed text either because they introduce legal or technical uncertainty or because they jeopardise the precarious balance that established a form of wording that all the European Union member states could sign up to in the first place. A call for all GM organisms to carry a unique identifying genetic tag, for instance, was unacceptable to the Commission.

In a statement, Commissioner Wallström urged the European institutions to “work together to finalize this important piece of legislation rapidly.” These sentiments were echoed by Simon Barber, director of plant biotechnology at the biotechnology industry umbrella, EuropaBio. “What everybody needs,” he says, “is something that can get put in place quickly so that we can get on with our business. We would like the public to see how it works.”

Willy De Greef, head of regulatory and governmental affairs at Novartis Seeds (Basel, Switzerland), typifies industry's ambivalence about the Parliament's decision. “On the one hand, it is a very positive thing that the legislative process is nearing an end,” he says. ”But whether this is going to make any difference will depend on the political climate and public opinion.”

Companies with advanced agricultural biotechnology products were particularly pleased with the exclusion of some of the amendments that could have “killed off the technology.” The amendment to prevent gene flow was one of these. Another was a call for an immediate ban on products containing antibiotic resistance genes: The toned-down proposal accepted by the European Parliament called only for the phasing out of resistance markers by 2005, and then only for antibiotics that are in clinical or veterinary use. The Parliament also agreed to remove proposals that would have burdened companies with specific liability for environmental harm associated with their product. However, that concession came at the expense of a commitment to the Parliament from Commissioner Wallström to introduce general environmental liability rules before the end of 2001.

The conciliation process will take around six months, meaning that the legislation will be enacted during the French presidency of the EU. This would be somewhat ironic given the role of Dominique Voynet, the French Green minister for regional planning and the environment, in instituting the de facto moratorium on the approval of GM crops in Europe: An agreement between Voynet and another Green minister of the environment, Italian Edo Ronchii, with the support of their counterparts from Austria, Luxembourg, and Denmark, meant that this group has been able to form a sufficiently large minority on the Council of Environment Ministers to block the approval of any product.

It had been hoped that this political blockage would be removed by the completion of the revision of 90/220. That now seems unlikely. Following the April vote in the European Parliament, Voynet declared that the political moratorium should remain in place until there is legislation that ensures that GM products can be traced through the entire production chain, from planting to plate.

Italian politicians are still making hard-line anti-GM statements, too. Even though Ronchii has been replaced in the new Italian government as minister for environment by Willer Bordon of the center-left Democratic party, another Green, Alfonso Pecoraro Scanio, has become minister of agriculture. Scanio has already said definitively that no trials of GM crops will take place in Italy during his administration.

Beyond the moratorium, there are opportunities for further stalling: Even if a revised 90/220 directive is agreed upon between the Council of Ministers and the Parliament this summer, individual European countries will still have 18 months to implement it.

Meanwhile, the European Commission is working to encourage industry to participate in what it is calling the “proactive approach,” according to officials. In essence, this would involve companies resubmitting on a voluntary basis revised product approval applications with the new data outlined in the revised directive. Monsanto (St. Louis, MO) and Aventis Crop Science (Frankfurt) have already indicated that they would be willing to make concessions that would satisfy new requirements on issues such as labeling, traceability, monitoring, and public information. However, De Greef believes that for Novartis this could be a retrograde step. Given that products such as the company's Bt maize are well advanced, De Greef says, “I would rather have the files stuck where they are stuck now than to go back to the beginning of a new process.” He points out that the scientific part of the approval system is working well but that “at the end of that process, there is still political interference.”

Barber from EuropaBio is generally supportive of the thinking behind the “proactive” approach, but he can see why individual companies might be reticent following the reactions to the Parliamentary vote from Voynet and her colleagues. “The commission is expecting companies to act in good faith,” says Barber, “and yet it is not at all clear that the member states will do so, too.”

European Commission officials say that proposals currently stuck in the old system would have priority, but they admit that companies would be taking a risk in resubmitting. The alternative they point to, however, is to maintain the current standoff and to risk further enflaming political and public antipathy.

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Hodgson, J. Industry still fears political opposition to European Union GM legislation. Nat Biotechnol 18, 589 (2000).

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