A sustainability assessment framework for genome-edited salmon

In this paper we present a suggestion for a sustainability assessment framework using genome editing of salmon as a case study. The salmon farming industry is facing several challenges hindering sustainable production. Genome editing has entered as a tool that can improve selective breeding and feed ingredients in aquaculture, hence providing solutions such as resistance to salmon lice and other pathogens, and sterility reducing interbreeding with wild, threatened stocks. As a goal for aquaculture is that its practices and products contribute to sustainability, the use of genome editing needs to be assessed with regards to sustainability, too. In our work, we draw on three sources of information; strategy and policy documents published by governmental offices and industry organizations; relevant GMO regulations and operationalization reports; and qualitative empirical data from 19 semi-structured interviews with Norwegian key stakeholders, and four semi-structured citizen groups. The findings from our analyses are discussed in relation to a Wedding cake-model for sustainability developed at the Stockholm Resilience Centre based on the UN SDGs and the three pillars of sustainability: biosphere, society, and economy. Analysis of document and interview data shows three main findings, one within each of the sustainability pillars. First, we identified that the biosphere pillar, including protection of the environment and the wild salmon, is the major sustainability issue and therefore important for the assessment of sustainability in the aquaculture industry and for the potential introduction of genome-edited salmon. Second, in the pillar for society the preservation of cultural and natural resources should be included, and in the Norwegian context this includes preserving the Sámi culture reliance on the wild salmon stocks. Third, in the economy pillar animal welfare needs to be included both for efficiency and ethical responsibility in farming. With some adoption to local and national conditions and the fish species in question, the same framework can be used for sustainability assessment of genome edited finfish in general.publishedVersio

New Developments in Biotechnology and IPR in Aquaculture – Are They Sustainable?

The objective of this chapter is to give an overview and analysis of the current trends and developments in biotechnology in aquaculture research and management. The technological developments along with structural changes in the aquaculture sector may affect access and intellectual property rights (IPR) regimes. These issues will be discussed in a wide perspective involving both short and long-term biological effects, ethical and other social aspects (economic, legal and political issues), including their partly inherent contradictions needing compromising for sustainable development. The chapter will focus on current biological challenges within aquaculture as a growing food production sector, with less emphasis on external effects such as environmental effects. Cases from farmed salmon and cod in Norway in addition to shrimp and tilapia in Asia will be highlighted

Mapping Uncertainties in the Upstream: The Case of PLGA Nanoparticles in Salmon Vaccines

The diversity of nanotechnologies and of the governance challenges that their applications raise calls for exploration and learning across different cases. We present an Upstream Oversight Assessment (UOA) of expected benefits and potential harms of nanoparticles made of a synthetic polymer (PLGA) to improve vaccines for farmed salmon. Suggested by Jennifer Kuzma and colleagues, an UOA may help identify and prioritise research needs, and it may support evaluations of the adequacy of relevant existing regulatory frameworks. In this work, the UOA approach is modified and supported with elements from the uncertainty analysis framework developed by Warren Walker and colleagues. Empirically, we draw on relevant available published literature and insights generated in an ongoing nanoparticle salmon vaccine project, in which one of the authors participates. Nanotechnologies have not previously been encountered in the regulatory context of fish vaccines, which in part raises unique challenges due to prospective large scale vaccine use in semi-open aquatic systems. Strengthened through cooperation between ELSA and technology researchers we found the UOA useful for an early mapping of benefits and concerns, and for identifying areas in need of further research prior to a nanoparticle based salmon vaccine is developed and taken into use. We consider our approach to represent one among several complementing initiatives that seek to contribute to early stage evaluations of possible negative side effects, broadly conceived, in order to facilitate a more robust nanotechnology development

Genome editing on finfish: Current status and implications for sustainability

Novel genome editing techniques allow for efficient and targeted improvement of aquaculture stock and might be a solution to solve challenges related to disease and environmental impacts. This review has retrieved the latest research on genome editing on aquacultured finfish species, exploring the technological progress and the scope. Genome editing has most often been used on Nile tilapia (Oreochromis niloticus Linnaeus), followed by Atlantic salmon (Salmo salar Linnaeus). More than half of the studies have focused on developing solutions for aquaculture challenges, while the rest can be characterized as basic research on fish genetics/physiology or technology development. Main traits researched are reproduction and development, growth, pigmentation, disease resistance, use of trans-GFP and study of the omega-3 metabolism, respectively. There is a certain correlation between the species identified and their commercial relevance, indicating the relevance of most studies for present challenges of aquaculture. Reviewing geographical origin of the research, China has been in the forefront (29 publications), followed by the United States (9) and Norway (7). The research seems not to be dependent on regulative conditions in the respective countries, but merely on the purpose and objectives for the use of genome editing technologies. Some technical barriers identified in the studies are presented together with solutions to overcome these-off-target effects, ancestral genome duplication and mosaicism in F0. One of the objectives for use is the contribution to a more sustainable aquaculture, where the most prominent issues are solutions that contribute to minimizing impact on biodiversity

With great power comes great responsibility: why ‘safe enough’ is not good enough in debates on new gene technologies

New genomic techniques (NGTs) are powerful technologies with the potential to change how we relate to our food, food producers, and natural environment. Their use may afect the practices and values our societies are built on. Like many countries, the EU is currently revisiting its GMO legislation to accommodate the emergence of NGTs. We argue that assessing such technologies according to whether they are ‘safe enough’ will not create the public trust necessary for societal acceptance. To avoid past mistakes of under- or miscommunication about possible impacts, we need open, transparent, and inclusive societal debate on the nature of the science of gene (editing) technologies, on how to use them, and whether they contribute to sustainable solutions to societal and environmental challenges. To be trustworthy, GMO regulation must demonstrate the authorities’ ability to manage the scientifc, socio-economic, environmental, and ethical complexities and uncertainties associated with NGTs. Regulators and authorities should give equal attention to the refexive and the emotional aspects of trust and make room for honest public and stakeholder inclusion processes. The European Group of Ethics in Science and Technology’s recent report on the Ethics of Genome Editing (2021) is important in calling attention to a series of fundamental issues that ought to be included in debates on the regulation and use of NGTs to ensure public trust in these technologies and in regulating authorities. With the great power of NGTs comes great responsibility, and the way forward must be grounded in responsible research, innovation, and regulation

From ethics of restriction to ethics of construction: ELSA research in Norway

Current trends in ELSA policies are marked by keywords like collaboration, integration and Responsible Research and Innovation (RRI). This article analyzes how these trends have manifested themselves in Norway with the aim to find ways to understand and respond adequately to these policy developments. Recent criticisms of ELSA strategies accompanied by arguments for a turn towards ‘post-ELSI’ research approaches hold that ELSA research was designed to maintain a sharp unproductive normative division of labor between natural scientists on the one hand and ELSA researchers on the other hand. ELSA strategies consequently have to be overcome and restructured towards collaboration, integration and RRI. Our account of the Norwegian ELSA history does not support this simple analysis of the ‘modernist’ character of early ELSA strategies. We present and analyze a shift as it took place in two successive ELSA programs in the Research Council of Norway, and argue that ELSA policies that rest only on post-ELSI analyses, risk reinventing the wheel of collaboration. By insisting on the creation of novel designing strategies, one disregards important lessons from the early phases of ELSA research, and even more importantly, fails to recognize that an ethics of construction implies different challenges for different groups of ELSA researchers.

Structured analysis of broader GMO impacts inspired by technology assessment to inform policy decisions.

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.publishedVersio