Til dokument

Sammendrag

The Norwegian Scientific Committee for Food and Environment (VKM) initiated this work to examine the extent to which organisms developed by genome-editing technologies pose new challenges in terms of risk assessment. This report considers whether the risk assessment guidance on genetically modified organisms, developed by the European Food Safety Authority (EFSA), can be applied to evaluate potential risks of organisms developed by genome editing. Background Gene technology has allowed for the transfer of genes between organisms and species, and thereby to design altered genotypes with novel traits, i.e. GMOs. A new paradigm started in the early 2000s with the development of genome-editing techniques. Unlike traditional genetic modification techniques resulting in insertion of foreign DNA fragments at random locations in the genome, the new genome-editing techniques additionally open for a few single nucleotide edits or short insertions/deletions at a targeted site in an organism’s genome. These new techniques can be applied to most types of organisms, including plants, animals and microorganisms of commercial interest. An important question is how the novel, genome-edited organisms should be evaluated with respect to risks to health and the environment. The European Court of Justice decided in 2018 to include genome-edited organisms in the GMO definition and hence in the regulatory system already in place. This implies that all products developed by genome-editing techniques must be risk-assessed within the existing regulatory framework for GMOs. The European and Norwegian regulatory frameworks regulate the production, import and placing on the market of food and feed containing, consisting of or produced from GMOs, as well as the release of GMOs into the environment. The assessment draws on guidance documents originally developed by EFSA for risk assessment of GMOs, which were drawn up mainly to address risks regarding insertion of transgenes. The new genome-editing techniques, however, provide a new continuum of organisms ranging from those only containing a minor genetic alteration to organisms containing insertion or deletion of larger genomic regions. Risk assessment of organisms developed by genome editing The present discourse on how new genome-editing techniques should be regulated lacks an analysis of whether risk assessment methodologies for GMOs are adequate for risk assessment of organisms developed through the use of the new genome-editing techniques. Therefore, this report describes the use of genome-editing techniques in food and feed production and discusses challenges in risk assessment with the regulatory framework. Specifically, this report poses the question as to whether the EFSA guidance documents are sufficient for evaluating risks to health and environment posed by genome-edited plants, animals and microorganisms. To address these questions, the report makes use of case examples relevant for Norway. These examples, intended for food and feed, include oilseed rape with a modified fatty acid profile, herbicide-tolerant and pest-resistant crops, sterile salmon, virus-resistant pigs and hornless cattle. The report considers all aspects of the stepwise approach as described in the EFSA guidance documents. Conclusions The inherent flexibility of the EFSA guidance makes it suitable to cover health and environmental risk assessments of a wide range of organisms with various traits and intended uses. Combined with the embedded case-by-case approach the guidance is applicable to genome-edited organisms. The evaluation of the guidance demonstrates that the parts of the health and environmental risk assessment concerned with novel traits (i.e. the phenotype of the organism) may be fully applied to all categories of genome-edited organisms. ............

Til dokument

Sammendrag

The emergence of antibiotic-resistant pathogens has caused a serious worldwide problem in infection treatment in recent years. One of the pathogens is methicillin-resistant Staphylococcus aureus (MRSA), which is a major cause of skin and soft tissue infections. Alternative strategies and novel sources of antimicrobials to solve antibiotic resistance problems are urgently needed. In this study, we explored the potential of two broad-spectrum bacteriocins, garvicin KS and micrococcin P1, in skin infection treatments. The two bacteriocins acted synergistically with each other and with penicillin G in killing MRSA in vitro. The MICs of the antimicrobials in the three-component mixture were 40 ng/ml for micrococcin P1 and 2 μg/ml for garvicin KS and penicillin G, which were 62, 16, and at least 1,250 times lower than their MICs when assessed individually. To assess its therapeutic potential further, we challenged the three-component formulation in a murine skin infection model with the multidrug-resistant luciferase-tagged MRSA Xen31, a strain derived from the clinical isolate S. aureus ATCC 33591. Using the tagged-luciferase activity as a reporter for the presence of Xen31 in wounds, we demonstrated that the three-component formulation was efficient in eradicating the pathogen from treated wounds. Furthermore, compared to Fucidin cream, which is an antibiotic commonly used in skin infection treatments, our formulation was also superior in terms of preventing resistance development.

Sammendrag

Plants are exposed to various pathogens in their environment and have developed immune systems with multiple defense layers to prevent infections. However, often pathogens overcome these resistance barriers, infect plants and cause disease. Pathogens that cause diseases on economically important crop plants incur huge losses to the agriculture industry. For example, the 2016 outbreak of strawberry grey mold (Botrytis cinerea) in Norway caused up to 95% crop losses. Such outbreaks underline the importance of developing novel and sustainable tools to combat plant diseases, for example by increasing the plants’ natural disease resistance. Priming plant defenses using chemical elicitors may enhance resistance against multiple pathogens. Such an approach may reduce the use of chemical fungicides and pesticides that often select for resistant strains of pests and pathogens. My presentation will focus on the effectiveness of different chemical agents to prime woodland strawberry (Fragaria vesca) defenses against the necrotroph B. cinerea. We have identified several genes that seem to play a role in disease resistance in strawberry and associated epigenetic memory mechanisms. Our results point out new management avenues for more sustainable crop protection schemes.

Sammendrag

Plants are exposed to various pathogens in their environment and have developed immune systems with multiple layers of defence to fight-back. However, often pathogens overcome the resistance barriers, infect the plants to cause the disease. Pathogens that cause diseases on economically important crop plants like strawberry incur huge losses to the agriculture industry. For example, The 2016 outbreak of strawberry grey mould (Botrytis cinerea) in Norway caused up to 95% crop losses. Outbreaks like this underline the importance of developing novel and sustainable tools to combat plant diseases, for example by increasing the plants’ natural disease resistance. Priming plant defences using chemical elicitors may be effective in providing the enhanced resistance against multiple pathogens. We have used β-aminobutyric acid (BABA) as a chemical priming agent to induce resistance in Fragaria vesca against Botrytis cinerea. Effects of BABA on disease progression and defence responses of Fragaria are being characterized using molecular tools like RNAseq, RT-PCR and ChIP. As priming chemicals may induce an epigenetic memory in treated plants, we also plan to study the histone methylation patterns in primed plants and the genes that are regulated. Our long-term aim is to understand the duration of the epigenetic memory and its cross-generational transmission to the progeny in Fragaria. Our results will help guide various crop protection strategies in addition to providing new insights to develop novel tools for plant disease management.

Til dokument

Sammendrag

Plant research and breeding has a long and successful history in the Scandinavian countries, Denmark, Finland, Norway and Sweden. Researchers in the region have been early in adopting plant gene technologies as they developed. This review gives a background, as well as discuss the current and future progress of plant gene technology in these four countries. Country-specific details of the regulation of genetically modified plants are described, as well as similarities and differences in the approach to regulation of novel genome-editing techniques. Also, the development of a sustainable bioeconomy may encompass the application of plant gene technology and we discuss whether or not this is reflected in current associated national strategies. In addition, country-specific information about the opinion of the public and other stakeholders on plant gene technology is presented, together with a country-wise political comparison and a discussion of the potential reciprocal influence between public opinion and the political process of policy development. The Scandinavian region is unique in several aspects, such as climate and certain agriculturally related regulations, and at the same time the region is vulnerable to changes in plant breeding investments due to the relatively small market sizes. It is therefore important to discuss the role and regulation of innovative solutions in Scandinavian plant research and breeding.

Sammendrag

Redigering av gener gjer at vi står framfor ein heilt ny debatt om bioteknologi, seier Bioteknologirådets leiar Kristin Halvorsen.