Critical analysis and proposal for changes and additions to the Bolivian Biosafety Regulation (DS 24676) in order to have a functioning National Committee on Biotechnology Safety

Abstract

Bolivia produced approximately 1.3 million hectares of biotech soybean in 2017. This area made it the fourth largest biotech crop producer in Latin America by area, being surpassed only by Argentina, Brazil and Paraguay. Furthermore, Bolivia has been included among the top ten biotech crop planting countries in the world. Nevertheless, the only approved event in Bolivia is the soybean GTS 40-3-2, approved in 2008 after years of a de facto moratorium on biotech crops. The main legal instrument regulating biotech crops in Bolivia is the Regulation on Biosafety, approved by the Supreme Decree (DS) 24676, on June of 1997. This Regulation mainly regulates the conformation and functioning of the National Biosafety Committee (CNB). The application of this norm has been difficult. The application for approval of the event GTS 40-3-2 was presented in 1998, and its approval took approximately 10 years. From 2008, the CNB has not functioned and consequently, no new events have been approved. As a consequence, Bolivia has not developed a working system (human resources, administrative structure, working tools, etc.) capable of evaluating new applications. Furthermore, the Regulation is outdated since no changes have been made to it for more than 20 years. The application of the Regulation may be improved by implementing new tools and perspectives that have been developed in recent years. This proposal summarizes a number of additions and changes that can be made to the norm in the present Bolivian context, including new Bolivian legislation (i.e. a new Constitution and new laws based on it), and new positions of the public on the subject. It tries to incorporate the latest research and ideas on the topic of functioning regulatory systems. The proposal may help to reactivate the CNB so it can evaluate application for new biotech crops, and in the future, new biotech organisms.