Establishment of the Uruguayan biosafety framework and a regulatory perspective of environmental risk assessment for transgenic crops engineered with complex traits

ESTABLISHMENT OF THE URUGUAYAN BIOSAFETY FRAMEWORK AND A REGULATORY PERSPECTIVE OF ENVIRONMENTAL RISK ASSESSMENT FOR TRANSGENIC CROPS ENGINEERED WITH COMPLEX TRAITS By María Alejandra Ferenczi Gardini With increasing world population and anticipated impacts of climate change, there is a need to develop crop varieties that provide increased productivity while preserving biodiversity and the environment. Genetic engineering is one of the techniques available to be used in plant breeding for crop improvement. This technology has the potential to generate a broad range of new products, including organisms with significantly altered morphology and physiology. Use of these new technologies and the potential impact of the resultant products have led to a cautious attitude determining that GE crops follow a different regulatory pathway than new varieties derived from conventional breeding programs. In this thesis I discuss the establishment of a biotechnology biosafety regulatory system in Uruguay, its comparison with other systems in the region and the analysis of environmental safety questions from a regulatory point of view. In recent years the Uruguayan regulatory system for GE organisms has undergone consolidation in response to political support of biotechnology. The legal support is based on Decree 353/008 and is slowly progressing to law. This thesis describes development of an operational system to handle applications including establishment of an administrative system which supports the risk analysis phases of risk assessment; risk management; and risk communication; and an operational system for follow-up actions of monitoring, surveillance and inspection. The Uruguayan approach is next compared with those of Argentina, Brazil and Paraguay, which together form the Southern Common Market (MERCOSUR for its acronym in Spanish). The objective was to identify from divergences new strategies for improvement of the Uruguayan system, and from commonalities potential approaches for harmonization. Harmonization could potentially achieve a more efficient and effective framework for the use of economic, infrastructure and human resources, and avoid problems of asynchronous authorizations. While difficult to coordinate the approval of GE organisms for commercial use throughout the region, specific suggestions are proposed with actions toward harmonization. Finally, the thesis addresses risk analysis for crops engineered with complex traits such as dehydration stress tolerance. These traits may utilize genes that encode transcription factors, signalling factors, metabolic pathway enzymes, among others, with the potential to initiate a cascade of cellular changes that may produce unanticipated effects on plant metabolism, physiology, and/or development with biosafety implications. As a result, the application review for environmental biosafety may be more complex as we move from the first wave of genetically engineered crops, such as insector herbicide tolerant crops for which the gene product directly confers the trait of interest, to crops with more complex traits. It should be noted, however, that while important to evaluate, pleiotropic effects are not a hazard per se. Rather, the same ultimate harms must be evaluated, whether those harms arise due to primary effects of the gene, or pleiotropic or unintended effects. A conceptual framework is developed for regulators when analyzing environmental risk assessments of transgenic crops with complex traits. A case study is performed for release of cucumber expressing the Arabidopsis thaliana dehydration stress tolerance transcription factor gene, CBF, into the Uruguayan environment.