Assessing environmental releases of genetically modified organisms: policy considerations of benefits and risks

Genetically modified organisms (GMOs) hold enormous potential to improve human and environmental health, yet may also entail potential risks. GMO regulation in the European Union, as in most countries, occurs solely via a risk analysis, with no consideration given to benefits of the proposed technology, nor to the relative risks of competing technologies. Thus, decision-making is not contextualised & suffers from inconsistencies and ambiguities. A more robust approach to GMO regulation requires balancing benefits against risks via a risk-benefit analysis (RBA). Several regulatory approaches based on RBA are used to evaluate both GM and non-GM technologies worldwide. These can serve as precedents and parallels to guide the integration of RBA for GMO regulation. Avenues forward include enabling comparisons of relative risks, regulating products not processes, and regulating systems not technologies. A legislative framework for GMO regulation based on RBA would provide a balanced, transparent and consistent approach to decision-making. Assessing environmental releases of genetically modified organisms: