Chapter 3: Risks, perceptions and the law: regulatory approaches to risk
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Different perceptions of risk can lead to different approaches to risk assessment and risk management. From a general perspective, a distinction can be drawn between two main regulatory approaches. First, the ‘product’ or ‘vertical’ approach, which centres on the features of a finalized biotech product. The United States and many other countries follow this approach. Second, the ‘process’ or ‘horizontal’ approach, which focuses on the production process rather than on the final product and which inspires EU regulation. These alternatives have played a fundamental role, for example, in the regulation of new methods of genetic engineering. Some international instruments additionally allow to take the socio-economic impact of some biotech products (e.g. living modified organisms) into account. Regulations are normally justified on objective, scientific criteria. However, scientific evidence does not always provide certainty about risks and thus leaves a corridor for policy choices. In international law, the precautionary principle covers restrictive measures in the face of potential risks which have not yet been established conclusively.

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