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An Assessment of Current Regulation of GMOs in the EU

Vesco Paskalev argues that the regulation of GMOs in the EU is a shambles. The main problem lies in a very narrow conception of risk and safety. Paskalev proposes specific legal amendments to remedy these faults.

All the emphasis is wrongly on laboratory tests, and evidence on the wider environmental effects is scant.  Wider studies on the effects on consumption patterns or the cost pressures on non GM farmers are ignored.  In addition, experts supplant the proper role of the political institutions, and the precautionary principle is rendered inoperative. Paskalev proposes specific legal amendments to remedy these faults.
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The regime of centralised authorisation of production and trade of genetically modified organisms (GMO) in the EU is a shambles but recent amendment proposals do not even begin to address the problem.

Although in its own review the European Commission recognises that the regulation now in force does not work, it insists on keeping it intact, and is prepared only to allow recalcitrant states to opt out of it by banning GMO varieties which are already authorised by the EU.

The main problem with the EU approach to GMOs is in its narrow understanding of risk and safety. To overcome the persistent political controversy on the issue, member states have adopted a system where final decisions are heavily dependent on expert assessment of the safety of each individual variety. Thus ‘science’ is supposed to carry the day, and who can be ‘against science’?

However, what counts as science is itself a contentious issue. The view that is enshrined in law confines science above all to laboratory experiments, e.g. whether rats fed on the GMOs develop abnormally. The effect of GMOs on the environment into which they are released is also taken into account, but such data is less readily available, especially data on longer term and larger scale effects. On the other hand, studies of, for example, the effect of GMO on existing farming practices and consumption patterns, or the costs imposed on farmers who wish to remain GM-free, are excluded completely. On this view they would be considered a matter of politics, and non-science — even if social studies can provide plenty of data for various adverse effects.

Further to this major design flaw, the present report identifies a number of other problems in the existing legislation:

  • the expert assessment effectively preempts the judgement of the political institutions, such as the Commission and the Council. Such delegation is impermissible under the Treaty of Rome.
  • in this way the precautionary principle is rendered inoperative.

To remedy the situation the regime must be amended. This report offers a number of specific amendments to the text of the relevant secondary legislation which boil down to the following:

  • the responsibility of the Commission and the margin of discretion in any decision need to be recognised and made explicit.
  • uncertainty of any assessment and provisionality of any judgement must be acknowledged; lack of evidence should not be equated with lack of effect.
  • risk managers should be put back in charge of risk analysis by allowing them to feed back into the risk assessment requests for consideration of the anticipated effect of their final decision; in turn, risk assessors should consider various scenarios.
  • procedural details and voting rules should be revised, to restore the functionality of the committees of national experts Regulating GMOs 4 (‘comitology’) in order to restore the political control which has been blocked for a dozen years now.
  • The independence of the risk assessor (the European Food Safety Authority, EFSA) should be restored by diversifying the expertise of its members and employees.
  • Opportunity for public participation should be enhanced by requiring consideration of all factors which are relevant for the stakeholders rather than discarding most of their concerns as non-scientific
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