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Abstract Purpose 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. Main features 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). Results 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. Conclusions 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.

The Convention on Biological Diversity opens the possibility to negotiate a legally binding Biosafety Protocol to assess and minimize risks in the field of transboundary transfer, handling, and use of organisms modified by genetic engineering. Two principles— the Precautionary Principle and the Principle of Familiarity—guiding the risk assessment as basis of import decisions on such organisms are discussed. Developing and European industrialized countries favor the Precautionary Principle. The U.S., Australia, Japan, and some others call for the Principle of Familiarity. These two principles exhibit opposite effects on scientific progress in general and on scientific methodology of risk assessment in particular. With the example of risk assessment by the U.S. company Monsanto discussed below, it could be illustrated that the Principle of Familiarity opens the way for superficial evaluations based on citing arbitrary references while the Precautionary Principle is an incentive for developing and applying sound methodology in experimental risk assessment. on the transboundary transfer of such LMOs, for example, on the international exchange of and trade with transgenic seeds, grains, animals, or bacteria. The negotiations are based on Articles 19.3 and 8(g) of the Convention on Biological Diversity, elaborated during the Earth Summit in Rio de Janeiro, Brazil, in 1992, and on Decision II/5 of the Second Conference of the Parties to this Convention in Jakarta, Indonesia, in 1995 (see the appendix; for more documents, see www.biodiv.org). Until the Fourth Conference of the Parties in 1998, 172 states ratified this convention. This conference decided to finish the Biosafety Protocol in February 1999. In 1998, transgenic crops were allowed to be planted in eight (75%) countries of the world. As the country with the largest acreage of transgenic crops and as the main trader of LMOs, the United States cannot become a member of the protocol until it has ratified the Convention on Biological Diversity.

Der Autor analysiert die Grundlagen neofaschistischer Ideologie in Deutschland und erläutert deren Auswirkungen auf Jugendliche, insbesondere auf Angehörige jugendlicher Subkulturen. Hauptschwerpunkt neofaschistischer Ideologie bildet nach Maßgabe des Verfassers nicht mehr der Antisemitismus. Dieser wird durch eine strikte Ausländerfeindlichkeit ersetzt als Instrument der psychologischen Kriegführung gegen Demokraten und Linke. Diesen wird Verrat am Deutschen Volk unterstellt, da sie von den Prinzipien politischer und sozialer Gleichheit aller Menschen ungeachtet ihrer Nationalität ausgehen. In diesem Sinne bildet der Begriff der "nationalen Identität" den argumentativen Kern. Die "Pflicht des Deutschen, zuerst als Deutscher zu denken", führt zu einer Negierung egalitären und demokratischen Denkens und zu Apardheit als praktische Konsequenz. Am Ende seines Beitrages geht der Autor auf die neofaschistische Ansprache von Jugendlichen ein, wobei er zwei Formen charakterisiert: die der "Lagerfeuerromantik" und die des militanten Aktivismus, der sich vornehmlich auf Angehörige jugendlicher Subkulturen wie Skinheads und Fußballfans konzentriert. (ICC)

A 2-year rat feeding study with genetically modified NK603 maize sparked an international scientific and public debate as well as policy responses by the European Commission. The European Food Safety Authority (EFSA) evaluated the study as defective based on conceptual and methodological shortcomings by retroactive application of the recommendations of its recent guidance on 90-day feeding studies. Our comparative analysis of the three relevant NK603 publications, including a 90-day feeding study of Monsanto, showed that all of them satisfy or fail to satisfy the EFSA evaluation criteria to a comparable extent; the rejection of only one of the papers is, thus, not scientifically justified. We also show that EFSA's criteria are not standard practice in 21 other rat feeding studies lasting at a minimum of 12 months. The review reveals critical double standards in the evaluation of feeding studies submitted as proof of safety for regulatory approval to EFSA. We specifically argue that the current approach to declare statistically significant differences between genetically modified organisms and its parents as 'biologically irrelevant' based on additional reference controls lacks scientific rigor and legal justification in the European Union (EU) system. Only recently, the EU authorities started building up an implementing system based on its own legislation and supportive of the EU approach to risk assessment in the context of technology assessment. Until these issues are resolved, we do not expect that neither the public nor the scientific debate will subside. ; ISSN:2190-4715 ; ISSN:2190-4707

Abstract A 2-year rat feeding study with genetically modified NK603 maize sparked an international scientific and public debate as well as policy responses by the European Commission. The European Food Safety Authority (EFSA) evaluated the study as defective based on conceptual and methodological shortcomings by retroactive application of the recommendations of its recent guidance on 90-day feeding studies. Our comparative analysis of the three relevant NK603 publications, including a 90-day feeding study of Monsanto, showed that all of them satisfy or fail to satisfy the EFSA evaluation criteria to a comparable extent; the rejection of only one of the papers is, thus, not scientifically justified. We also show that EFSA's criteria are not standard practice in 21 other rat feeding studies lasting at a minimum of 12 months. The review reveals critical double standards in the evaluation of feeding studies submitted as proof of safety for regulatory approval to EFSA. We specifically argue that the current approach to declare statistically significant differences between genetically modified organisms and its parents as 'biologically irrelevant' based on additional reference controls lacks scientific rigor and legal justification in the European Union (EU) system. Only recently, the EU authorities started building up an implementing system based on its own legislation and supportive of the EU approach to risk assessment in the context of technology assessment. Until these issues are resolved, we do not expect that neither the public nor the scientific debate will subside.

AbstractWe identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA's GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU's GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA's prevailing approach to GM crop and food risk assessment starts from what it terms a 'comparative safety assessment'. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA's 'comparative safety assessments' draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a 'comparative safety assessment', EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are 'answered' only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA's approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.

We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA's GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU's GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA's prevailing approach to GM crop and food risk assessment starts from what it terms a 'comparative safety assessment'. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA's 'comparative safety assessments' draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a 'comparative safety assessment', EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are 'answered' only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA's approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly. ; ISSN:2190-4715 ; ISSN:2190-4707

The assessment of the impacts of growing genetically modified (GM) crops remains a major political and scientific challenge in Europe. Concerns have been raised by the evidence of adverse and unexpected environmental effects and differing opinions on the outcomes of environmental risk assessments (ERA). The current regulatory system is hampered by insufficiently developed methods for GM crop safety testing and introduction studies. Improvement to the regulatory system needs to address the lack of well designed GM crop monitoring frameworks, professional and financial conflicts of interest within the ERA research and testing community, weaknesses in consideration of stakeholder interests and specific regional conditions, and the lack of comprehensive assessments that address the environmental and socio-economic risk assessment interface. To address these challenges, we propose a European Network for systematic GMO impact assessment (ENSyGMO) with the aim directly to enhance ERA and post-market environmental monitoring (PMEM) of GM crops, to harmonize and ultimately secure the long-term socio-political impact of the ERA process and the PMEM in the EU. These goals would be achieved with a multi-dimensional and multi-sector approach to GM crop impact assessment, targeting the variability and complexity of the EU agro-environment and the relationship with relevant socio-economic factors. Specifically, we propose to develop and apply methodologies for both indicator and field site selection for GM crop ERA and PMEM, embedded in an EU-wide typology of agro-environments. These methodologies should be applied in a pan-European field testing network using GM crops. The design of the field experiments and the sampling methodology at these field sites should follow specific hypotheses on GM crop effects and use state-of-the art sampling, statistics and modelling approaches. To address public concerns and create confidence in the ENSyGMO results, actors with relevant specialist knowledge from various sectors should be ...