Kristin Hagen

If genetically modified organisms (GMOs) are approved in the EU for experimental release or marketing authorization (placing on the market), a risk assessment (RA) is carried out beforehand to determine whether this may be associated with negative effects on human health, nature or the environment. Applications are reviewed by the European Food Safety Authority (EFSA) and the national Competent Authorities of the Member States. However, the potential ramifications of the GMOs that are systematically addressed in the current RA context are limited. Broader consideration can include environmental and health aspects beyond the scope of the statutory RA, as well as societal, ethical and cultural impacts. These other levels of impact may be considered during the comitology process of authorisation, but how this is done is typically not made explicit in a systematic way. However, with the dynamic developments of new kinds of GMOs, these considerations as well as transparency regarding the role of broader considerations in political decision-making become more and more relevant. Against this backdrop, we identified the requirements and suggest the main elements for such a broader assessment. We use insights from the field of Technology Assessment (TA) to explore the requirements for operationalising a rapid but still systematic, transparent and broad case-by-case GMO assessment compatible with the existing legislative framework.

Synthetic biology" is the label of a new technoscientific field with many different facets and agendas. One common aim is to "create life", primarily by using engineering principles to design and modify biological systems for human use. In a wider context, the topic has become one of the big cases in the legitimization processes associated with the political agenda to solve global problems with the aid of (bio-)technological innovation. Conceptual-level and meta-level analyses are needed: we should sort out conceptual ambiguities to agree on what we talk about, and we need to spell out agendas to see the disagreements clearly. The book is based on the interdisciplinary summer school "Analyzing the societal dimensions of synthetic biology", which took place in Berlin in September 2014. The contributions address controversial discussions around the philosophical examination, public perception, moral evaluation and governance of synthetic biology.

Die 4. Auflage bringt zunächst die Kommentierung der Präambel und der Art. 1 bis 19 auf den aktuellen Stand von Judikatur und Literatur. Die grundlegende Struktur des Kommentares wurde beibehalten und um neuere Entwicklungen wie die Implikationen der Europäisierung und Digitalisierung sowie der Corona-Pandemie ergänzt.Die Herausgeberschaft des Kommentares hat ab der 4. Auflage Frauke Brosius-Gersdorf übernommen. Auch im Autorenkreis sind personelle Veränderungen zu verzeichnen: Mit Ausnahme von Frauke Brosius-Gersdorf, Alexander Thiele und Ferdinand Wollenschläger, die bereits an der 3. Auflage mitgewirkt haben, liegen die Kommentierungen in den Händen neuer Autorinnen und Autoren.Der Kommentar erscheint in drei Bänden und wird nur geschlossen abgegeben.Der Grundgesetz-Kommentar ist Bestandteil des Moduls Verfassungsrecht PREMIUM, das bei beck-online.de erhältlich ist.

Editorial: Concepts of Animal Welfare Content Type Journal Article Pages 93-103 DOI 10.1007/s10441-011-9134-0 Authors Kristin Hagen, Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr-Ahrweiler GmbH, Wilhelmstr. 56, 53474 Bad Neuenahr-Ahrweiler, Germany Ruud Van den Bos, Behavioural Neuroscience, Animals in Science and Society, Faculty of Veterinary Medicine, Rudolf Magnus Institute of Neuroscience, Utrecht University, Yalelaan 2, 3584 CM Utrecht, The Netherlands Tjard de Cock Buning, Department of Biology and Society (ATHENA Institute), Faculty of Earth and Life Sciences, Vrije Universiteit, De Boelelaan 1087, 1081 HV Amsterdam, The Netherlands Journal Acta Biotheoretica Online ISSN 1572-8358 Print ISSN 0001-5342 Journal Volume Volume 59 Journal Issue Volume 59, Number 2

In science policy, public controversy around synthetic biology has often been presented as a major risk because it could deter innovation. The following inter-related strategies for avoiding contestation have been observed: There have been attempts to close down debates by alluding to the importance and legitimacy of reliance on scientific evidence as input to regulatory processes. Scientific policy advice has stressed sufficiency of existing regulation, economic risks of additional regulation and/or suggestions for monitoring that are limited in scope. Initiatives for self-governance have narrowed the scope of topics for consideration. Engagement with humanities, social sciences and arts has been co-opted for legitimisation and science communication. Although such agendas are of course not ubiquitous, in this paper, I criticise that instrumentally motivated engagement has been supported not only by the scientific community but also by policy institutions and funding bodies. I argue that it is good that this now seems to fuel controversy in the academic and policy realms. As synthetic biology is not the only technoscientific field to see such dynamics, this is also part of the broader context of debate about the governance of science, especially the concept of “responsible research and innovation” currently promoted in the EU.