Response to Bagavathiannan and Van Acker's "Transgenes and national boundaries - The need for international regulations": Biotechnology developers and regulators already consider transgene movement across national boundaries and the environmental risks posed by adventitious presence of unapproved events are overstated.

Bagavathiannan and Van Acker propose greater international cooperation and information sharing in risk assessment for biotechnology-derived crops because pollen- and seed-mediated gene flow across political boundaries may lead to the adventitious presence of unapproved transgenes at sites along the borders of neighboring countries. However, they fail to convince us that something is wrong with the current situation and provide no details of how it could be improved.

How does scientific risk assessment of GM crops fit within the wider risk analysis?

The debate concerning genetically modified crops illustrates confusion between the role of scientists and that of wider society in regulatory decision making. We identify two fundamental misunderstandings, which, if rectified, would allow progress with confidence. First, scientific risk assessment needs to test well-defined hypotheses, not simply collect data. Second, risk assessments need to be placed in the wider context of risk analysis to enable the wider 'non-scientific' questions to be considered in regulatory decision making. Such integration and understanding is urgently required because the challenges to regulation will escalate as scientific progress advances.