Market stage precautions: managing regulatory disharmonies for transgenic crops in Europe

Levidow, Les; Carr, Susan and Wield, David (1999). Market stage precautions: managing regulatory disharmonies for transgenic crops in Europe. In AgBiotechnet AgBiotechNet.

URL: http://www.cabi.org/agbiotechnet/Default.aspx?site...

Abstract

In the European Union transgenic crops are undergoing a transition to the commercial stage, amidst conflicts over the predictability and acceptability of their potential effects. It has been difficult to harmonize regulatory criteria under the EC Deliberate Release Directive. Despite pleas for 'science-based regulation', there are disagreements over the relevant uncertainties and the burden of scientific evidence for resolving them. More EU member states have adopted more stringent criteria for evaluating and preventing undesirable effects. Moves towards the commercial stage have become dependent upon market-stage precautions: which link cultivation protocols, field monitoring, ecological models and related research. Initially these links have been developed for two transgenic crops: insect-protected maize (carrying the Bacillus thuringiensis endotoxin gene) and glufosinate-tolerant oilseed rape. Implicitly, market-stage precautions redefine key regulatory terms, e.g. the 'step-by-step procedure' and 'adverse effects'. Such efforts manage regulatory disharmonies, both within and among EU member states, at the same time as managing risk itself.

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