The Cartagena Biosafety Protocol is the primary driving force behind countries establishing national biosafety regulatory systems for genetically engineered crops and animals. That international agreement attempts to set forth the scientific and legal boundaries for those systems, and establish a minimum set of rules and procedures. This paper analyses whether the Protocol will achieve a degree of legal certainty in the field of biosafety regulations and some level of global harmonization. The paper concludes that, while the Protocol is a good model for certain portions of a national biosafety regulatory system, it provides little guidance on several issues key to biosafety regulation. The Protocol gives discretion to individual countries to decide on what the applicable safety standard should be, how to incorporate socioeconomic considerations, how to address food safety and how to incorporate public participation. The resolution of these four issues by each country could have a far greater influence than the Protocol itself on the nature of their national biosafety regulatory system.
Copyright © 2005 John Wiley & Sons, Ltd.