The Cartagena Protocol on Biosafety allows the possibility of including socio-economic considerations in biosafety regulatory approval processes and decision making for genetically modified products. Divergent opinions about the desirability of including socio-economic considerations have polarized the debate. For biosafety approval processes, assessment of socio-economic considerations will likely be before the fact, as the genetically modified product has not reached commercialization approval processes. This implies that there is a limited scope as to methods and approaches for assessments. To ensure that socio-economic assessments will not become an obstacle to the development and transfer of safe and efficacious products to farmers, all stakeholders need to understand clearly all regulations governing inclusion of socio-economic considerations. Furthermore, the decision-making process needs to clearly define decision-making rules and standards by which to guide approval processes.