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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.

Machen Mitarbeiter:innen Fehlverhalten in Betrieben, Behörden und Regierungen öffentlich, ist das oft ein Wendepunkt in ihrem Leben. Diese Whistleblower oder Hinweisgeber, seit 1999 im zweijährigen Rhythmus mit dem Whistleblower-Preis vom deutschen Flügel der International Association of Lawyers against Nuclear Arms (IALANA) und der Vereinigung Deutscher Wissenschaftler (VDW) ausgezeichnet, berichten in Interviews über ihr Leben nach der Preisverleihung. Was ist aus den weltweiten Plänen für Kugelhaufenreaktoren geworden, sind Maßnahmen zur besseren Kontrolle von Apotheken für Krebsmedikamente ergriffen worden, ist Glyphosat verboten, die unkontrollierte Überwachung durch Geheimdienste gestoppt, der Pflegenotstand gemildert worden? In den Interviews durch Jurymitglieder sagen fast alle Preisträger:innen, dass sie sich trotz der oft andauernden Anfeindungen wieder so verhalten würden. Das Buch schließt mit einer kritischen Beurteilung des Weges hin zu einem Hinweisgeberschutzgesetz in Deutschland und ist dem Initiator des Whistleblower-Preises, Dr. Dieter Deiseroth, Richter am Bundesverwaltungsgericht, gewidmet

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

AbstractMisinformation has always existed, but it became a major preoccupation during the COVID-19 pandemic due to its ability to affect public health choices, decisions, and policy. In their article, "Misinformation in the media: Global coverage of GMOs 2019–2021" (GM Crops & Food, 17 Nov 2022), Mark Lynas et al. characterise critics of agricultural genetically modified organisms (GMOs) and their associated pesticides as purveyors of "misinformation". They draw an equivalence between critics of agricultural GMOs and people who make false claims about climate change, COVID-19, and vaccines. We examined their main claims on these GMOs—for example, that there is a scientific consensus that they are safe for health and the environment—in the light of the scientific evidence and public discussion on this topic. We found that their claims are biased and misleading and ignore or omit crucial evidence. We conclude that based on the evidence provided, Lynas et al. article can itself be classed as misinformation and could therefore mislead the general public as well as the scientific community.

Abstract
Background
In 2009, Spanish farmers reported a novel weed, now identified as a relative of maize's ancestor, teosinte, in their maize fields. Introgression of the insect resistance transgene cry1Ab from genetically modified (GM) maize into populations of this weedy Spanish teosinte could endow it with additional defense mechanisms. The aims of this study were: (1) to test if hybridization between GM maize and weedy plants from Spain is possible; (2) to understand the relationship between transgene transcription activity, concentrations of the expected transgene product (Cry1Ab protein) and the bioactivity of the latter on target insect pests following transgene flow from GM maize into Spanish teosinte plants.

Results
We demonstrated that hybridization between GM maize and the weedy Spanish teosinte is possible, with no observable barrier to the formation of crop/weed hybrids when teosinte served as pollen donor. When GM maize plants were used as pollen donors, significant crossing incompatibility was observed: hybrid plants produced only few "normal" seeds. Nevertheless, viable F1 seeds from GM pollen crossed onto teosinte were indeed obtained. The cry1Ab transgene was stably expressed as mRNA in all crossings and backgrounds. Similarly, toxicity on neonate Ostrinia nubilalis, presumably due to Cry1Ab protein, was consistently expressed in teosinte hybrids, with mortality rates 95% or higher after only 4 days exposure, similar to rates on parental GM maize plants. Nevertheless, no strong correlations were observed between transgene transcription levels and Cry1Ab concentrations, nor between Cry1Ab concentrations and insect mortality rates across all of the different genetic backgrounds.

Conclusions
Our results establish fundamental parameters for environmental risk assessments in the European context: first, we show that crop/weed hybridization in fields where maize and teosinte exist sympatrically can lead to potentially catastrophic transfer of resistance traits into an already noxious weed; second, our results question the viability of using gene dosage to model and predict ecological performance in either the intended crop plant or the undesired teosinte weed. Significant questions remain that should be addressed in order to provide a scientific, sound approach to the management of this novel weed.