The great potential of biotechnology also implies potential risks as seen from the perspectives of natural and social sciences. With the shortcomings in the current risk assessment processes there is a need for greater leadership in risk management. In this respect lessons can be learnt from three major situations; the nuclear power debate in the 1970s, hazardous chemicals, and pharmaceuticals exemplified by the thalidomide experience. Other formative events which have led to society's regulations are the Three Mile Island accident and Rachel Carson's book 'Silent Spring'. The socio-political climate in which genetically modified organisms (GMOs) are regulated is critically dependent on such events. Reference is made to the Consultative Forum on Biotechnology organized by the EU and the US in order to indicate critical factors which determine whether or not it will be possible to realise the potential of GMOs. Conclusions from the Forum concern the regulatory processes within the US and the EU, and on the global scale. Regulations aim at gaining the benefits and ameliorating the potentially negative consequences of a market economy, but also to increase public confidence in new products and processes.