Public Consultation on Proposed Revisions to Norway’s Gene Technology Act: An Analysis of the Consultation Framing, Stakeholder Concerns, and the Integration of Non-Safety Considerations

This is the final version. Available on open access from MDPI via the DOI in this recordData Availability Statement: Data is contained within the article. See Table A1 Source data for discourse analysis.In Norway, genetically modified organisms (GMOs) are regulated through the Gene Technology Act of 1993, which has received international attention for its inclusion of non-safety considerations. In 2017, the Norwegian Biotechnology Advisory Board triggered a process to revise the Act that included a public consultation and resulted in the “Proposal for relaxation.” Using post-structuralist discourse analysis, we critically analyze the premises and processes through which the proposal for relaxation was developed—including the public consultation—to understand the range of stakeholder concerns and how these concerns shaped the final proposal. We find that the proposal does not include all concerns equally. The Norwegian Biotechnology Advisory Board’s privileging of technological matters and its preference for tier-based regulation skewed the proposal in a way that reduced broader societal concerns to technological definitions and marginalized discussion of the social, cultural, and ethical issues raised by new gene technologies. To prevent such narrowing of stakeholder concerns in the future, we propose Latour’s model for political economy as a tool to gauge the openness of consultations for biotechnology regulation.Research Council of Norwa

Precaution or Integrated Responsibility Approach to Nanovaccines in Fish Farming? A Critical Appraisal of the UNESCO Precautionary Principle

Nanoparticles have multifaceted advantages in drug administration as vaccine delivery and hence hold promises for improving protection of farmed fish against diseases caused by pathogens. However, there are concerns that the benefits associated with distribution of nanoparticles may also be accompanied with risks to the environment and health. The complexity of the natural and social systems involved implies that the information acquired in quantified risk assessments may be inadequate for evidence-based decisions. One controversial strategy for dealing with this kind of uncertainty is the precautionary principle. A few years ago, an UNESCO expert group suggested a new approach for implementation of the principle. Here we compare the UNESCO principle with earlier versions and explore the advantages and disadvantages by employing the UNESCO version to the use of PLGA nanoparticles for delivery of vaccines in aquaculture. Finally, we discuss whether a combined scientific and ethical analysis that involves the concept of responsibility will enable approaches that can provide a supplement to the precautionary principle as basis for decision-making in areas of scientific uncertainty, such as the application of nanoparticles in the vaccination of farmed fish

Trust in Science: CRISPR-Cas9 and the Ban on Human Germline Editing

This is the final version of the article. Available from Springer Verlag via the DOI in this record.In 2015 scientists called for a partial ban on genome editing in human germline cells. This call was a response to the rapid development of the CRISPR-Cas9 system, a molecular tool that allows researchers to modify genomic DNA in living organisms with high precision and ease of use. Importantly, the ban was meant to be a trust-building exercise that promises a 'prudent' way forward. The goal of this paper is to analyse whether the ban can deliver on this promise. To do so the focus will be put on the precedent on which the current ban is modelled, namely the Asilomar ban on recombinant DNA technology. The analysis of this case will show (a) that the Asilomar ban was successful because of a specific two-step containment strategy it employed and (b) that this two-step approach is also key to making the current ban work. It will be argued, however, that the Asilomar strategy cannot be transferred to human genome editing and that the current ban therefore fails to deliver on its promise. The paper will close with a reflection on the reasons for this failure and on what can be learned from it about the regulation of novel molecular tools.The research leading to this paper has received funding from the European Research Council under the European Union’s Seventh Framework Programme (FP7/2007-2013)/ERC Grant Agreement No. 324186

Lipofection-based delivery of DNA vaccines

The preventive and therapeutic potential of DNA vaccines combined with benefits of lipid-based delivery (lipofection) allow efficient nucleic acid transfer and immunization applicable in treatment of infections, cancer or autoimmune disorders. Lipofecting compositions consisting of cationic and neutral lipids can be used for both in vitro and in vivo applications and may also play the role of adjuvants. Here we describe a simple protocol of DNA vaccine carrier preparation based on cationic polyprenyl derivatives (PTAI-trimethylpolyprenylammonium iodides) and commonly used helper lipids with use of basic laboratory equipment. Such formulas have proven effective for immunization of animals as well as for cell transfection