Abstract
Since more than 25 years, public dialogues, expert consultations and scientific publications have concluded that a comprehensive assessment of the implications of genetic engineering in agriculture and food production needs to include health, environmental, social and economical aspects, but only very few legal frameworks allow to assess the two latter aspects. This article aims to explain the divergence between societal debate and biosafety legislation and presents approaches to bring both together. The article reviews the development of biosafety regulations in the USA and the EU, focussing on diverging concepts applied for assessing the risks of genetically modified organisms (GMOs). The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. As a first step, methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders. Interestingly, there had been no attempts yet to link the existing frameworks of GMO risk assessment and SEA. It is recommended to adapt current models of SEA to assess the systemic risks of GMOs. It is also suggested to revise the EU GMO legislation to promote the inclusion of SEA elements.
Highlights
US genetically modified (GM) agriculture started with Bacillus thuringiensis (Bt) cotton planting in 1995, but it only was the introduction of Roundup Ready soybeans in 1996, being exported worldwide as basic ingredient for the feed and food industry that initiated the worldwide public debate on the use of GM crops
James reports that 15 countries grow more than 50,000 ha of GM crops each with a sum of 133.9 million hectares [1]
The debate on the regulation of genetic engineering in Europe focussed more on issues beyond corporate and economic issues. While this caused the legal character of the European Union (EU) legislation to be a process-based concept under the environmental law, the previously developed ecotoxicological concept of genetically modified organisms (GMOs) risk assessment were incorporated into the early EU legislation and the international Cartagena Protocol on Biosafety
Summary
The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. Methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders.
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