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The fast‐paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen‐oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products. This commentary proposes three strategies to improve biosecurity: Security must be treated as an investment in the future applicability of the technology; social scientists and policy makers should be engaged early in technology development and forecasting; and coordination among global stakeholders is necessary to ensure acceptable levels of risk. Graphical Abstract Biosecurity policies and practices must be updated to accommodate the novel challenges associated with synthetic biology and to maximize technological benefits while minimizing its dual‐use potential. This Commentary proposes three strategies to improve biosecurity.

Early on, scientists have pointed out that coronavirus disease 2019 is most likely here to stay, although its course and development are uncertain. This requires a long-term strategy of living with the virus. However, the urgency of new waves of infection and the emergence of new variants have invoked an approach of acute crisis management over and over, hindering the design of a structural approach for the long term. Exploratory scenarios can provide scientific strategic guidance to policy processes to be better prepared in this situation of fundamental uncertainty. We have therefore developed five scenarios, which describe the possible long-term development of the pandemic from an epidemiological, virological, and broader societal perspective. These scenarios are based on four driving forces that are both important and uncertain: immunity, vaccination, mutations, and human behavior. The scenarios are (1) return to normal, (2) flu+, (3) external threat, (4) continuous struggle, and (5) worst case. Working with scenarios is crucial for appropriate public communication and provides guidance for anticipating the various conceivable possibilities for the further course of the pandemic.

End of April 2021, the European Commission published its study on New Genomic Techniques (NGTs). The study involved a consultation of Member States and stakeholders. This study reveals a split on whether current legislation should be maintained or adapted to take account of scientific progress and the risk level of NGT products. This split was predictable. New technological developments challenge both ethical viewpoints and regulatory institutions; and contribute to the growing divide between science and society that value ‘technological innovations’ differently. Such controversies are often characterized as ‘unstructured’ because of nearly unbridgeable positions on entangled scientific and value-laden issues. Initiatives for stakeholder involvement, such as consultation or participation, often focus on reaching a ‘shared vision’ without exploring the diverse societal concerns and values behind these positions. To resolve the EU stalemate in NGT regulation, we advocate to bring back politics in the EU decision-making process instead of hiding it under the veil of science, the need for regulatory change and public support. A more productive and justified use of genuine stakeholder participation is possible, if participants and deliberation design meet the criteria of what we call participation ethics . Drawing from our applied experience exploring the ethics of genetic modification, we believe that this approach can lead to more robust political decision-making and restore societal confidence in the governance of contested issues such as NGTs.

Applications and techniques in biotechnology are rapidly integrating both inside and outside the life sciences. Techniques such as CRISPR-Cas are embraced as a one-size-fits-all tool in agricultural, environmental, medical and industrial biotechnology. Biotechnology merges with other technologies in amongst others synthetic biology, bionanotechnology and 3D bioprinting. These international developments are also confronted with both regulatory and societal challenges from the perspective of emerging risks, the socially contested status of genetically modified organisms and international regulatory differences. This brings forward the question how to organize innovation, safety and societal embedding of a scientifically normalizing—and therefore no longer separately visible—technology. This article highlights the overarching issues in biotechnology developments from a societal and regulatory perspective. Furthermore, recommendations are made on how to initiate responsible governance of a biotechnology that becomes mainstream.

Results of studies that cast doubt on the safety of genetically modified (GM) crops have been published since the first GM crop approval for commercial release. These ‘alarming studies’ challenge the dominant view about the adequacy of current risk assessment practice for genetically modified organisms (GMOs). Subsequent debates follow a similar and recurring pattern, in which those involved cannot agree on the significance of the results and the attached consequences. The standard response from the government—a reassessment by scientific advisory bodies—seems insufficient to bring the debate to a satisfactory closure. The recurrence of the same debate every time an alarming study is published shows that science alone cannot solve the problem. We believe that further analysis is needed to investigate if and how we can prevent this repetitive cycle that creates frustration amongst all stakeholders. In this paper, we analyse the dynamics behind discussions which occur following alarming studies. We will use a selection of representative alarming GMO case studies to underpin our claim that it is likely that there will be a permanent difference in view of opinion that cannot be solved with more data or new facts. The current strategy of more research is a pitfall that is unlikely to solve this issue. Instead, the focus of the GM crop discussion should shift towards managing permanent different viewpoints and providing a platform for a broader conversation on agriculture and food production.

Synthetic biology aims at designing biological systems, at building ‘living machines’. The emergence of synthetic biology has reignited the cycle of public debate. The old biotechnology debate is being reiterated and the controversies are deepened. The societal debate follows the technological hype cycle. A new technology with a high visibility and high expectations also raises high controversies. For synthetic biology, this hype is currently near its peak and the first signs of disillusionment are getting visible. In policy development, on the other hand, synthetic biology is in the early stages. Governments examine the need for adaptations to existing regulatory frameworks. There is a gap between the visibility of the technological developments and policy formulation. This gap is crucial for technology assessment: while the hype in public attention is over, essential policy steps are taken. In order to close this gap, technology assessment needs to facilitate the societal–ethical debate when media attention, and thus the visibility of the technological developments, declines.