Chapter 14 Innovation, Risk, Precaution, and the Regulation of GM Crops

Purpose – New genetically modified (GM) crops are novel but risky interventions, offering a variety of potential benefits but also the possibility of serious unintended consequences. I address the regulatory framework for GM crops, seeking protection from disproportionate risks without unduly stifling innovation. Approach – Conditions that may justify precautionary interventions are identified, and an idealized regulatory protocol (screening, pre-release testing, and post-release surveillance, STS) is developed to provide protection, encourage research and learning, and focus-in quickly on the cases that pose serious threats of harm. This protocol is adapted to the case of GM crops, and compared with current regulatory practice in the United States, the EU, and Canada, as well as international agreements exemplified by the Cartagena Protocol on Biosafety. Two real-world cases are considered, Starlink® corn and Roundup-Ready® canola, and some speculations are offered as to how the stylized protocol might have handled them. Findings for policy – Pre-release, US regulatory practice is more fragmented and incomplete than the stylized protocol; EU practice is more systematic and streamlined, but some critics perceive over-regulation; and Canadian regulatory practice is more consistent with the protocol. Only the EU performs systematic post-release surveillance. International agreements have various weaknesses, beginning with fragmentation: for example, food safety and biosafety are regulated separately. Implications for further research – Embracing the STS framework opens a broad new avenue of research about to how the mix of pre-release testing and post-release surveillance might be streamlined to provide adequate protection while reducing further the costs and delays entailed.