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This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been implemented in the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs.

Aquaculture is becoming the primary source of seafood for human diets, and farmed fish aquaculture is one of its fastest growing sectors. The industry currently faces several challenges including infectious and parasitic diseases, reduced viability, fertility reduction, slow growth, escapee fish and environmental pollution. The commercialization of the growth-enhanced AquAdvantage salmon and the CRISPR/Cas9-developed tilapia (Oreochromis niloticus) proffers genetic engineering and genome editing tools, e.g. CRISPR/Cas, as potential solutions to these challenges. Future traits being developed in different fish species include disease resistance, sterility, and enhanced growth. Despite these notable advances, off-target effect and non-clarification of trait-related genes among other technical challenges hinder full realization of CRISPR/Cas potentials in fish breeding. In addition, current regulatory and risk assessment frameworks are not fit-for purpose regarding the challenges of CRISPR/Cas notwithstanding that public and regulatory acceptance are key to commercialization of products of the new technology. In this study, we discuss how CRISPR/Cas can be used to overcome some of these limitations focusing on diseases and environmental release in farmed fish aquaculture. We further present technical limitations, regulatory and risk assessment challenges of the use of CRISPR/Cas, and proffer research strategies that will provide much-needed data for regulatory decisions, risk assessments, increased public awareness and sustainable applications of CRISPR/Cas in fish aquaculture with emphasis on Atlantic salmon (Salmo salar) breeding.

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 poststructuralist 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.

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.

The importance of socio-economic impacts (SEI) from the introduction and use of genetically modified (GM) crops is reflected in increasing efforts to include them in regulatory frameworks. Aiming to identify and understand the present knowledge on SEI of GM crops, we here report the findings from an extensive study of the published international scientific peer-reviewed literature. After applying specified selection criteria, a total of 410 articles are analysed. The main findings include: (i) limited empirical research on SEI of GM crops in the scientific literature; (ii) the main focus of the majority of the published research is on a restricted set of monetary economic parameters; (iii) proportionally, there are very few empirical studies on social and non-monetary economic aspects; (iv) most of the research reports only short-term findings; (v) the variable local contexts and conditions are generally ignored in research methodology and analysis; (vi) conventional agriculture is the commonly used comparator, with minimal consideration of other substantially different agricultural systems; and (vii) there is the overall tendency to frame the research upon not validated theoretical assumptions, and to over-extrapolate small-scale and short-term specific results to generalized conclusions. These findings point to a lack of empirical and comprehensive research on SEI of GM crops for possible use in decision-making. Broader questions and improved methodologies, assisted by more rigorous peer-review, will be required to overcome current research shortcomings.

Here we present the scope and administrative practice of the Norwegian Gene Technology Act. The main focus is on the objective of the environmental risk assessment which acknowledges both direct and indirect effects as well as immediate, delayed and cumulative effects on the environment. We describe the prohibition of two vaccines and seven applications of GM rapeseed. These applications are approved in Europe, but forbidden in Norway after taking environmental and biodiversity risks into consideration. The only approved GMOs in Norway are the import of five carnations, where the risk to the environment was not relevant. With the emergence of gene-edited organisms Norway does, as many other countries, discuss how to regulate, monitor and trace these organisms which represent a challenge to present regulative framework.

Marine bioprospecting offers possibilities for sustainable innovation based on marine genetic resources. How to regulate the use of such marine genetic resources entails several challenges. The rationale for the introduction of legislation on access and benefit sharing (ABS) from the use of genetic resources is elaborated using Norway as a case. Similarities and differences from other initiatives are presented with Australia as the comparative case. Several lessons are transferable to the Norwegian situation, and may also be of high relevance to other countries introducing ABS legislation. In both Norway and Australia, there is an expressed need for an ABS system that can include a model that is based on access permissions rather than mere registration. There are difficulties involved in monitoring the genetic material from access to actual commercial product, and in distinguishing between bioprospecting for scientific and commercial use, which complicates a determination of when benefit sharing should be triggered. We suggest that the idea of benefit-sharing could be supported by the principle of cost-sharing.

The importance of assessing socio-economic and sustainability aspects of genetically modified (GM) crops is increasingly recognized by policy-makers, both within the EU and internationally. Nevertheless, experience has shown that it is challenging to assess and implement these aspects in actual decision-making processes. This paper argues that stakeholder engagement may provide valuable insights when developing frameworks for sustainability assessment of GM crops. We organized two stakeholder workshops with the aim to gather perspectives on the sustainability of cultivating late blight resistant (LBR) GM potato in Norway. Sixteen Norwegian stakeholders involved in potato production and in agriculture in general took part in the workshops. Here, we present and discuss the outcomes of this participatory approach. The stakeholders identified several conditions that an LBR GM potato ought to satisfy in order to contribute to sustainable development. These conditions concerned environmental and health safety a...

DNA vaccines have great potential as preventive or therapeutic vaccines against viral, bacterial, or parasitic diseases as well as cancer, and may also be used as gene therapy products. Although many human and veterinary DNA vaccines have been investigated in laboratory trials, only four of these have been approved for commercial use. In this paper an overview of the regulatory requirements for the development of DNA vaccines is given. The regulatory process in EU and USA is described. A discussion concerning the relevance of national regulations on gene technology is included. In addition the main safety concerns associated with DNA vaccines, relating to unwanted side effects in the vaccinated mammal or fish, are presented. Finally, the need for greater openness regarding the assessment information is discussed.

Published version. Source at http://doi.org/10.1038/srep25096. License CC BY 4.0. The long-term persistence and activity of a naked plasmid DNA (pGL3-35S) containing a luc gene (reporter gene) controlled by a plant 35S CaMV promoter was studied in Atlantic salmon (Salmo salar L.) after injection. Atlantic salmon (mean weight 70 grams) were injected intramuscularly with 100 μg of plasmid DNA. Blood, different tissues and organs were sampled at different time points up to day 535 after injection. Southern blot analysis suggested the presence of extra-chromosomally open circular, linear and supercoiled topoforms of pGL3-35S at day 150 after injection. At day 536 open circular and supercoiled topoforms were detected. Luciferase activity was detected at the injection site up to 536 days post-injection of pGL3-35S, where it peaked at day 150 and decreased to approximately 17% of its maximum activity by day 536. Our study demonstrated that a plasmid containing the 35S promoter was able to induce expression of a reporter gene/protein in fish in vivo and that the plasmid DNA persisted for a prolonged time after intramuscular injection.

There is currently limited knowledge about the effects of introducing genetically modified (GM) crops into smallholder farming or about how biosafety requirements are interpreted and adopted by smallholders. A case study was conducted on introduction of GM (Bt) maize to South African smallholders. The results reveal low general awareness about agricultural technology among smallholders and an incompatibility between smallholder practices and biosafety requirements. The implications are low understanding of biosafety measures and low compliance. Therefore, essential prerequisites for the safe introduction of GM crops to smallholders are increased smallholder knowledge on modern plant varieties and improved agricultural advisory services that better match the smallholder context. In addition, information about GM crops and biosafety implementation must be modified to better suit smallholders.

The complexities of the socio-ecological systems of Arctic nature and communities challenge the science community and policy makers to take into account the interactions between economic development, ecological systems, and living conditions. Strong uncertainties regarding the extent of climate change impacts and their irreversible consequences amplify the need to consider Arctic economic development in a wider context of sustainable development. Precautionary approaches are needed to consider diverse economic, environmental, and ethical values when assessing the climate change impacts and proposals for adaptation on the sustainability of Arctic environments and communities. Discussing the relevance of a precautionary approach for the Arctic context, we present the framework outlined in the report ‘Late lessons from early warnings’ from the European Environmental Agency and provide suggestions and examples of how these lessons can serve as guidelines for knowledge-gathering processes and policy strategies...

Aquaculture is the fastest growing animal producing sector in the world and is expected to play an important role in global food supply. Along with this growth, concerns have been raised about the environmental effects of escapees and pollution, fish welfare, and consumer health as well as the use of marine resources for producing fish feed. In this paper we present some of the major challenges salmon farming is facing today. We discuss issues of relevance to how to ensure sustainability, by focusing on animal production systems, breeding approaches, sources for feed ingredients, and genetic engineering strategies. Other crucial issues such as animal welfare, environmental quality, and ethics are elaborated with regard to relevance for the sustainability of aquaculture. Additionally, we comment on socio-economic distributive implications by intellectual property rights (IPR) strategies on access to genetic material and traceability. To improve sustainability of salmon farming we suggest that there is a need for new approaches to guide research, for identification of ethical issues, and for engaging stakeholders in resolving these challenges.

The future of salmon aquaculture depends on the adoption of alternative feed resources in order to reduce the need for fish meal and fish oil. This may include resources such as species from lower trophic levels, by-products and by-catch from fisheries and aquaculture, animal by-products, plants, genetically modified (GM) plants, nutritionally enhanced GM plants and products from microorganisms and GM microorganisms. Here, we report on a deliberative assessment of these alternative feed resources, involving 18 participants from different interest groups within Norwegian salmon aquaculture. The participants defined a broad range of appraisal criteria concerning health and welfare issues, economical issues, environmental issues, and knowledge and social issues. A number of uncertainties, in the form of incomplete knowledge, diverging opinions, and context specific factors were identified when the participants evaluated the alternatives. Our findings support the need for more research on the suitability of alternative feed resources for farmed salmon. Additionally, the study underlines the importance of facilitating deliberative assessments in order to map the plurality of perspectives and explore qualitative aspects of uncertainty. Such initiatives improve the information base upon which decisions on future feed resources for farmed salmon are made.

The commercial introduction of genetically modified organisms (GMOs) has revealed a broad range of views among scientists and other stakeholders on perspectives of genetic engineering (GE) and if and how GMOs should be regulated. Within this controversy, the precautionary principle has become a contentious issue with high support from skeptical groups but resisted by GMO advocates. How to handle lack of scientific understanding and scientific disagreement are core issues within these debates. This article examines some of the key issues affecting precaution as a legal standard and as an approach to the use of science in decision-making processes. It is pointed out that there is a need for reflection over the level of scientific evidence required for applying the precautionary principle as well as who should have the burden of proof when there are uncertainties. Further, an awareness of the broader scientific uncertainties found in GMO risk assessment implies that a precautionary approach must be elaborated: both for acknowledging uncertainties and for identification of scientific responses. Since precaution is an important issue within the sustainable development framework, it is suggested that sustainability can provide a normative standard that can help to reveal the influence and negotiate the importance of the various forms of uncertainty. Wise management of uncertainties and inclusion of normative aspects in risk assessment and management may help to ensure sustainable and socially robust GMO innovations at present and in the future.

In this expert elicitation twelve Norwegian scientists were interviewed about environmental and health consequences of DNA vaccination in aquaculture. The intention was to elicit scientists’ judgments of potential sources of uncertainty associated with the use of DNA vaccines. Emphasis was put on three incidents: i) immune response following the DNA vaccination, ii) tissue distribution and expression of the injected plasmid DNA (pDNA) and iii) environmental release of DNA vaccines. We present what the experts identified as potential consequences of introducing DNA vaccines to aquaculture. Our findings support the need for more research on the stability of the pDNA, unintended immunological impacts and integration of the pDNA in the genome of the recipient organism. The study suggests that expert elicitation can improve communication of scientific uncertainty and thereby advance the scientific discussion. We argue that our findings support the importance of including several experts in the process of risk assessment and decision support, as different scientists express diverging opinions of the consequences involved.

Manuscript. Published version available in Journal of Applied Aquaculture Volume 28, 2016 - Issue 4 The aquaculture industry is under pressure to satisfy global demand for marine foods. Atlantic salmon has been bred for more than 40 years, and substantial progress has been made within the culturing and breeding programs. The improved growth rate of Atlantic salmon has been accompanied by an earlier onset of maturation. Among the factors controlling maturation in salmon are photoperiod, temperature, and body composition. Early sexual maturation is detrimental to fish health and quality when viewed from an aquacultural viewpoint. There are several approaches for alleviating this problem: (1) traditional selection, (2) manipulation of external factors affecting puberty (e.g., light), (3) novel biotechnological methods for improving breeding methods, (4) induction of polyploidy, and (5) genetic modification controlling maturation. This article presents the ecological and ethical issues connected to these approaches and argues the importance of acknowledging and discussing such issues in order to ensure that all stakeholder concerns are considered.

Socio-economic considerations are included in the regulatory frameworks on genetically modified organisms (GMOs) of many countries. This is a reflection of an increasing interest in and recognition of the necessity to consider a broader range of issues when conducting a GMO risk assessment. At the same time, there are discussions about how socio-economic considerations can be identified and how their assessment can be carried out. To provide an understanding of the advances achieved so far, we describe the state of the art of existing biosafety institutional frameworks, legislation and policies with provisions on socio-economic considerations. We analyse the scope of the socio-economic considerations that have been included, the methodological options taken and the role of participatory processes and stakeholders involvement in the GMO-related decision-making. Since many of the countries that have legislation for assessing socio-economic considerations lack implementation experience, we provide an analysis of how implementation has evolved in Norway with the intention to illustrate that the inclusion of socio-economic considerations might be based on a learning process. Norway was the first country to include broader issues in its GMO assessment process, and is at present one of the countries with the most experience on implementation of these issues. Finally, we emphasise that there is a great need for training on how to perform assessments of socio-economic considerations, as well as reflection on possible ways for inclusion of participatory processes.

In this study our aim was to investigate the persistence and distribution of plasmid DNA in Atlantic salmon. Atlantic salmon (mean weight 70 g) were injected with 100 microg of plasmid DNA in 100 microl of phosphate buffered saline. The fish were reared in running fresh water at temperature 0-12 degrees C and injections were performed at 8 degrees C. After intramuscular injection, samples were obtained from blood and different tissues and organs up to day 535 after injection. We found by use of Southern blotting open circular and supercoiled plasmid DNA at the injection site and plasmid DNA fragments, assessed by real-time PCR, were detected in some of the examined tissues up to day 535. A co-persistence of luciferase transcript and activity were identified at the injection site up to day 535, however analysis of DAM methylation pattern suggested that the plasmid DNA did not replicate in vivo. Our study indicated that the plasmid DNA can persist for a prolonged time after intramuscular injection.

Genetically engineered viruses (GEVs) used as live vaccines are, and will increasingly become, important for prevention of disease in human as well as animal populations. Poxviruses have a number of attractive theoretical and practical advantages as gene expressing vaccine vectors: their large genomes render construction of multivalent vaccines feasible, the vaccines are easy to produce, the virus particles are very thermostable, and inoculation is followed by long‐lasting, protective immune responses. On the other hand, administration and environmental release of GEVs may represent potential unintended harms to human, animal and ecosystem health. We will argue that a strict application of risk‐cost/benefit analyses do not cope appropriately with the current lack of scientific understanding and the complexity of ecosystems that will become GEV recipients, and fail to take into account the deeper ethical groundings that shape the scientific and public opinions. To avoid serious, unintended ecological effec...

How much is a wildflower worth? Inspired by “The worth of a songbird” by Funtowicz and Ravetz [Funtowicz, S.O., Ravetz, J.R., 1994. The worth of a songbird: ecological economics as a post-normal science. Ecological Economics 10, 197–207] we use the value of a wildflower as symbol of the complexity of evaluating environmental qualities and risks. We critically discuss the application of cost-benefit analysis in evaluating environmental impacts of adoption of genetically modified organisms (GMOs). We argue that cost-benefit analysis should be supplemented with other methods, such as processes for assessing uncertainty, accommodation of scientific disagreements, and integration of stakeholders' interests and perspectives. A more inclusive perspective is to develop precautionary approaches that recognize the multidimensional nature of environmental qualities and risks, such as irreplaceability, irreversibility, uncertainty and complexity. Precautionary approaches can contribute to develop a stronger environmental responsibility within the framework of rational self-interest.

Within aquaculture, genetic engineering (GE) is emerging as a powerful method for breeding of fish and shellfish, and for developing alternative sources of feed and vaccines to combat diseases. On the other hand, the use of GE in aquaculture raises ecological, ethical and economic concerns. For instance, genetically modified (GM) feed could be spread to the aquatic environment and consumed by other marine organisms, and horizontal gene transfer may conceivably occur from DNA in feed or vaccines to a recipient genome or by faeces to the environment. Numerous reports have described beneficial effects such as viral disease resistance following DNA vaccination. However, side effects, such as activation of other genes than those which are central in immune defence mechanisms, may occur and warrant further investigations. In order to achieve sustainable introduction of GE, it is crucial that appropriate scientific investigations and ethical considerations are done prior to large-scale introduction of GE products such as DNA/GE vaccines and GM feed in commercial fish farming. This may result in a solid basis for the avoidance of potentially undesirable health and environmental effects. If GE can help make aquaculture a sustainable industry, this opens the possibility of positive market and consumer responses. This can best be achieved by involving the stakeholders from the conceptual stage to the commercial stage by facilitating a transparent process whose purpose is to inform research, to identify decision stakes, and to influence design, adoption and implementation of pro-active policy.

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.'' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns.

Commercialization of genetically modified organisms (GMOs) have sparked profound controversies concerning adequate approaches to risk regulation. Scientific uncertainty and ambiguity, omitted research areas, and lack of basic knowledge crucial to risk assessmentshave become apparent. The objective of this article is to discuss the policy and practical implementation of the Precautionary Principle. A major conclusion is that the void in scientific understanding concerning risks posed by secondary effects and the complexity ofcause-effect relations warrant further research. Initiatives to approach the acceptance or rejection of a number of risk-associated hypotheses is badly needed. Further, since scientific advice plays a key role in GMOregulations, scientists have a responsibility to address and communicate uncertainty to policy makers and the public. Hence, the acceptance of uncertainty is not only a scientific issue, but is related to public policy and involves an ethical dimension.

This article criticizes recent suggestions that the current ELSI research field should accommodate a new direction towards a ‘post-ELSI’ agenda. Post-ELSI research seeks to avoid the modernist division of responsibility for technical and social issues said to characterize ELSI research. Collaboration and integration are consequently the key terms of post-ELSI strategies that are to distinguish it from ELSI strategies. We argue that this call for a new direction relies on an inadequate generalized analysis of ELSI research as modern that will affect the construal of post-ELSI strategies. We are concerned that the call for post-ELSI shift will exclude imaginative proposals and intellectual freedom by narrowing down the scope and methodologies of ELSI and thereby missing opportunities to play a critical and constructive normative role. Instead of framing current trends in ELSI research as a radical and progressive shift from ELSI to post-ELSI, we suggest an alternative story of expansion and diversification described in terms of a drift from ELSA 1 to ELSA 2, pertaining to acronyms in use in Europe. ELSI research has never been modern. It has been experimenting from the very start on ways to mesh the works of humanist, social and natural scientist in order to bridge and build alignments of emerging scientific and societal goals and matters of concern. The development from ELSA 1 to ELSA 2 expands in our account the range of intellectual and methodological capacities of analysis and engagement of complex and dynamic science-society relationships. We present three areas of ELSA expertise to illustrate that the expertise within the field builds on scholarly achievements within the humanities, social sciences as well as the natural sciences. The plurality of disciplinary background of ELSA researchers represents a valuable diversity that enables mutual criticism and formulations of complementary approaches that together constitute a viable ELSA field. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Climate change and human activities are the main reasons for the increasing degradation of ecological systems. Advances within modern biotechnologies, as genetic engineering and synthetic biology, hold promises for saving endangered species and revival of extinct species. The same biotechnologies are followed with concerns for unforeseen environmental harm. This has resulted in a call for regulation, including the application of the precautionary principle. There are, however, significant disagreements on how to apply the precautionary principle and how to handle risk. A key question concerns the meaning of the precautionary demand to avoid ‘morally unacceptable harm’ to the environment (UNESCO COMEST 2005) when applying new technologies. This needs further elaboration and we will draw some lessons from the controversies surrounding the introduction of genetically modified organisms (GMOs). Some similarities are for instance related to how to acknowledge risk and uncertainties, the existence of systemic properties of ecosystems and how to study the effect of changes induced in ecosystems. It has been argued that risk claims and awareness to uncertainties depend on assumptions about which facts and values are to be considered and which are to be left out. This may have implications for what we consider to be environmental harm as well as how we regard the significance of environmental harm that is identified.

Climate change and increased global population give rise to a special emphasis on how agriculture can expand production under changing conditions. Agriculture has also seen radical changes the last century with a turn towards research-based, industrialized agriculture with large-scale monocultures, mechanization, increased irrigation, use of artificial fertilizers, and pest control systems, combined with a change from local towards export-orientedmaking of products to be used for food, feed, fuel, and fiber. Biotechnology-based interventions such as systematic breeding, as witnessed in the Green Revolution, and genetic modification have led to commercially successful but politically controversial herbicide-tolerant and pest-resilient varieties of major crops, with promises of a wide range of new varieties in the years to come. In recent years nanotechnology methods and products have been added to the techno-scientific possibilities of improvements to agricultural production. As yet, there are few if any commercially available products, but nanotechnology holds promises for increasing efficiency within animal and plant breeding; for increased nutritional value, and production inputs as feed additives, chemicals, and pesticides; for new efficient means for diagnosis and surveillance of diseases; as well as possibilities for precision farming techniques. Moreover, also with importance for agriculture is the possibility for using nanosensors for detecting and removing salt and pollutants from water and soil. Here some of these new developments will be briefly presented, with focus mainly on the agriculture production system and not on food products as such (packaging, detection of contaminants and pathogens, nano barcodes, etc.). New emerging technologies as nanotechnology can be used for solving problems as well as enhancing production and efficiency but do also raise questions with regard to food and environmental safety and socio-economic, ethical, and regulatory issues that will be highlighted.

Introduction, Origin, Status and Effects of the Precautionary Principle * PART I: European Community Law * The Precautionary Principle in European Community Health and Environment Law: Sword or Shield for the Nordic Countries? * PART II: Comparative Analysis of the Precautionary Principle in the Nordic Countries * Denmark * Finland * Iceland * Norway * Status of Precaution in the Nordic Countries: A Comparative Analysis * PART III: The Precautionary Principle and the Law of the Sea - A Nordic Perspective * The Precautionary Principle and the Helsinki Commission * The Precautionary Approach and Fisheries: A Nordic Perspective * PART IV: Precaution, Genetically Modified Organisms and Biodiversity * Uncertainty and Precaution: Challenges and Implications for Science and the Policy of Genetically Modified Organisms * Genetically Modified Organisms in European Union Law * Genetically Modified Organisms and Precaution in Norwegian Law * Genetically Modified Organisms and Precaution in Finnish and Swedish Law * The Precautionary Principle and Nature Conservation Law: EU and Danish Experiences * PART V: The Precautionary Principle and Chemicals * The Precautionary Principle in Swedish Chemicals Law and Policy * Risks, Costs and Alternatives in European Community Environmental Legislation * The Impact of the Registration, Evaluation and Authorization of Chemicals (REACH) Regulation on the Regulatory Powers of the Nordic Countries * The Legacy of the Precautionary Principle in US Law * Conclusion, Lessons From International, EU and Nordic Legal Regimes.*

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.

Genetically engineered or modified viruses (GMVs) are being increasingly used as live vaccine vectors and their applications may have environmental implications that must be taken into account in risk assessment and management processes. In most legislative frameworks GMVs are treated as GMOs (genetically modified organisms), which require ERA (environmental risk assessment) in addition to the evaluation of the quality, safety and efficacy of the product before marketing authorization or clinical trial applications are submitted. The ERA is performed in order to identify the potential risks for public health and the environment that may arise due to the use and release of GMVs. If risks are identified and considered as not acceptable, the ERA process should go on to propose appropriate risk management strategies capable to reduce these risks (Anliker et al., 2010; Kuhler et al, 2009).

Norwegian fish farming is currently world leading both in quantity and in employing new technologies. Within Norway, aquaculture has become a large industry and represents a new way of income along the coast. However, the growth of aquaculture in Norway has been accompanied by controversy related both to potentially harmful internal effects on the fish themselves, namely animal welfare and health of the farmed salmon, and potentially harmful impacts on wild salmon by escapees from the farms and by transmission of parasites and diseases from farms to wild salmon. The introduction of salmon farming is also perceived as a threat to the wild salmon and its attached traditional cultural practices. Wild salmon plays a significant cultural role in Norway, connected to traditional ways of life on the Norwegian coast, as well as more recent practices such as recreational river angling. Public and environmental NGOs has also raised concerns about land-use change in coastal areas and the extensive use of marine resources for producing fish feed, environmental pollution from the farms, and socio-economic distributional effects by developments in the aquaculture sector. We will here explore the cultural significance of the Norwegian wild salmon, as well as its importance in a biodiversity perspective. On this background, we will discuss in what ways technological interventions as introduction of vaccines developed by biotechnologies as well as using new initiatives for breeding as marker assisted selection and genetic modification have significance for the salmon’s iconic status. Does such introduction change the nature of the species and to what extent does this represent a threat to the value of the wild salmon? The technological interventions are altering the salmon and even if one can argue that there are positive aspects to the domestication of the salmon, these technological interventions may also cause adverse consequences for the salmon, e.g. welfare issues and impacts on wild salmon. Furthermore, both traditional salmon fisheries and modern recreational river angling are negatively affected by the consequences of the industry. We will explore whether the ionic status of the animal is important for the nature of the controversies and to what extent such interventions may alter the iconic value of the Norwegian salmon.

Deliberate release of genetically modified organisms (GMOs) may contribute to sustainable development, world food supplies and economic prosperity. On the other hand, environmental release may initiate serious, irreversible ecological damage. In this article we discuss the scientific basis for regulation of GMO use, and to which extent present risk assessment procedures provide means to predict and reduce potential ecological hazards. Potential hazards related to gene transfer from GMOs to indigenous organisms and prospects of secondary ecological effects are given special attention. It is important to recognize that possible adverse ecological effects may have impact on other processes affecting human and animal welfare. A major conclusion is that the present state of scientific knowledge is inadequate for reliable ecological risk assessment. The basic information with regard to mechanisms governing the environmental interactions of GMOs is insufficient. The ecosystems are too complex, and our understanding of them too fragmentary. Furthermore, currently available methods to monitor short and long-term ecological consequences of GMO release are non-existent or unreliable. Finally, the socio–economic and biodiversity aspects of GMO usage are ambiguous, and often unpredictable, based on the present state of knowledge. Hence, applying the precautionary principle should be an important basis for initiation of risk-associated research as well as for elaboration of more satisfactory risk assessment methods and procedures.Keywords: deliberate GMO release, horizontal gene transfer, naked DNA, the precautionary principle.

This article is part of Børge Fredriksen's doctoral thesis, which is available in Munin at http://hdl.handle.net/10037/4153 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.

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.

Many interpretations of the precautionary principle do not provide a basis for adequate decision-making in regard to ecological and ethical questions. The article disagrees with the opinion that the precautionary principle is not scientific and gives reasons for an enlargement of scientific methods. The author agitates for an argumentative use of the concept, which has sustainable acting as its fundament.

“….Taking the structure and functioning of the Arctic regional economies and the degree of economic dependence as a point of departure, these region's self-reliance and comparative socio-economic performance is analyzed. The fundamental problem is still the dependency Arctic regions have on their mother economies in the south” “….the impact from climate changes and the global economy strongly influence the self-sufficiency constraints and potentials of the Arctic societies. Traditional approaches to economic valuation may not be sufficient to capture these relationships. Neo-classical economics and the trade off model look upon nature as a good commensurable with all other goods, and henceforward there is a substitution possibility. The rational self-interest and 'homo economicus' is however, not the same as responsible self-interest included in ecological economics. This suggests broader approaches to environmental uncertainties, which take into account ethical values and conflicts of interest”. Contributors: Hans Aage, Iulie Aslaksen, Andrée Caron, Gérard Duhaime, Solveig Glomsröd, Jón Haukur Ingimundarson, Ivar Jonsson, Jack Kruse, Joan Nymand Larsen, Svein Mathiesen, Anna Ingeborg Myhr, Birger Poppel, Rasmus Ole Rasmussen, Erik Reinert, Hugo Reinert, Chris Southcott, Gorm Winther, Lyudmila Zalkind.

The controversy surrounding genetically modified organisms (GMOs) has been a highly politicized issue in Europe. While opponents of GM crops maintain that scientific risk assessments are not sufficient to address potential long‐term hazards for health or the environment, proponents have criticized the current regulatory framework for being influenced by political and other non‐scientific interests. In this regard, it is interesting to compare the situation in Norway, which is linked to, but not bound by European Union (EU) law and which places a comparatively strict regulatory burden on GMOs. Here, we briefly present our assessment of applications to market GMOs in Norway, and how they fulfil the criteria of sustainable development and societal utility that are required by the Norwegian Gene Technology Act. The Norwegian Directorate for Nature Management in Trondheim requested the study (Myhr & Rosendal, 2009), but the results have implications beyond Norway as other countries are also exploring ways to integrate socio‐economic considerations into the national regulation of GMOs. After an initially liberal approach to GMO technology, Norwegian civil society, including farmers’ organizations, has become largely opposed to such organisms and the regulatory approach in Norway now places more emphasis on environmental, health and societal concerns. In fact, the legislation covering GMOs …

The Walker and Harremoes (W&H) uncertainty framework is a tool to systematically identify scientific uncertainty. We applied the W&H uncertainty framework to elicit scientists' judgements of potential sources of uncertainty associated with the use of DNA vaccination in aquaculture. DNA vaccination is considered a promising solution to combat pathological fish diseases. There is, however, lack of knowledge regarding its ecological and social implications. Our findings indicate that scientists are open and aware of a number of uncertainties associated with DNA vaccination e.g. with regard to immune response, degradation and distribution of the DNA plasmid after injection and environmental release, and consider most of these uncertainties to be adequately reduced through more research. We proceed to discuss our experience of using the W&H uncertainty framework. Some challenges related to the application of the framework were recognised. This was especially related to the respondents' unfamiliarity with the concepts used and their lack of experience in discussing qualitative aspects of uncertainties. As we see it, the W&H framework should be considered as a useful tool to stimulate reflection on uncertainty and an important first step in a more extensive process of including and properly dealing with uncertainties in science and policymaking.

Climate change impacts in the Arctic require that complex relationships between the economy, the environment, and the living conditions of indigenous and local people be taken into account. While traditional approaches to economic valuation may not be sufficient to capture these relationships, the research area of ecological economics suggests broader approaches to environmental uncertainties, taking into account ethical values and conflicts of interest. Increased activity in petroleum exploration, manufacturing, transportation, tourism and other services have the potential to alter the Arctic environment and societies considerably. Application of the precautionary principle is suggested as a way to manage situations with large degrees of environmental uncertainty and potentially irreversible consequences. Precautionary approaches require the development of processes for acknowledgement of uncertainties, facilitation of stakeholder participation, recognition of ethical values, and taking into account the traditional ecological knowledge of indigenous people of the Arctic. Combining traditional and scientific knowledge about nature is an important part of understanding the resilience capacity of ecological and social systems, and of enhancing the potential for sustainable development.