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Grey mold caused by the necrotrophic fungal pathogen Botrytis cinerea can affect leaves, flowers, and berries of strawberry, causing severe pre- and postharvest damage. The defense elicitor β-aminobutyric acid (BABA) is reported to induce resistance against B. cinerea and many other pathogens in several crop plants. Surprisingly, BABA soil drench of woodland strawberry (Fragaria vesca) plants two days before B. cinerea inoculation caused increased infection in leaf tissues, suggesting that BABA induce systemic susceptibility in F. vesca. To understand the molecular mechanisms involved in B. cinerea susceptibility in leaves of F. vesca plants soil drenched with BABA, we used RNA sequencing to characterize the transcriptional reprogramming 24 h post-inoculation. The number of differentially expressed genes (DEGs) in infected vs. uninfected leaf tissue in BABA-treated plants was 5205 (2237 upregulated and 2968 downregulated). Upregulated genes were involved in pathogen recognition, defense response signaling, and biosynthesis of secondary metabolites (terpenoid and phenylpropanoid pathways), while downregulated genes were involved in photosynthesis and response to auxin. In control plants not treated with BABA, we found a total of 5300 DEGs (2461 upregulated and 2839 downregulated) after infection. Most of these corresponded to those in infected leaves of BABA-treated plants but a small subset of DEGs, including genes involved in ‘response to biologic stimulus‘, ‘photosynthesis‘ and ‘chlorophyll biosynthesis and metabolism’, differed significantly between treatments and could play a role in the induced susceptibility of BABA-treated plants.

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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. ............

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The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of soy leghemoglobin produced from genetically modified Komagataella phaffii for food uses in the EU. In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation. The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law. Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation. In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during scientific hearings initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission. The assignment is divided into three stages. Soy leghemoglobin produced from genetically modified Komagataella phaffii This application is submitted to gain authorisation for the use of soy leghemoglobin (the liquid preparation is referred to as “LegH Prep”) produced from genetically modified Komagataella phaffii (yeast) as a flavouring (“meaty taste”) in meat analogue products that will be marketed in the European Union (EU). Soy leghemoglobin is intended for addition to meat analogue products that are for use in foods such as burgers, meatballs, and sausages. Komagataella phaffii-strain employed in the production of soy leghemoglobin contains genetic modifications which allow it to express this protein. Following fermentation, the cells are lysed, and the soy leghemoglobin is concentrated by physical means. The soy leghemoglobin is delivered in a liquid preparation (LegH Prep) that is standardised to contain up to 9% soy leghemoglobin on a wet weight basis and a soy leghemoglobin protein purity of at least 65%. The remainder of the protein fraction in the LegH Prep is accounted for by residual proteins from the Komagataella phaffii production strain. These residual proteins are all endogenous to Komagataella phaffii as the gene coding for the expression of soy leghemoglobin is the only gene from a different organism. VKM has assessed the documentation in application EFSA-GMO- NL-2019-162 and EFSA's scientific opinion for the use of soy leghemoglobin produced from genetically modified Komagataella phaffii. The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified microorganisms for use in food or feed. The VKM GMO Panel does not consider leghemoglobin from genetically modified Komagataella phaffii to imply potential specific health risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment was not performed by VKM. About the assignment: (...)

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The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize DP51291 for food and feed uses, import and processing in the EU. In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation. The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law. Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation. In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during scientific hearings initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission. The assignment is divided into three stages. Genetically modified maize DP51291 Genetically modified maize DP51291 (application GMFF-2021-0071) was developed via Agrobacterium tumefaciens mediated transformation. DP51291 plants contain the transgenes ipd072Aa and pat which encode the proteins IPD072Aa and PAT (phosphinothricin acetyltransferase). IPD072Aa confers protection against susceptible corn rootworm pests, and the PAT protein confers tolerance to glufosinate herbicide. The phosphomannose isomerase (PMI) protein that was used as a selectable marker. VKM has assessed the documentation in application GMFF-2021-0071 and EFSA's scientific opinion on genetically modified maize DP51291. VKM concludes that the applicant's scientific documentation for the genetically modified maize DP51291 is satisfactory for risk assessment, and in accordance with EFSA guidelines for risk assessment of genetically modified plants for food or feed uses. The genetic modifications in maize DP51291 do not indicate an increased health or environmental risk in Norway compared with EU countries. EFSA's risk assessment is therefore sufficient also for Norwegian conditions. As no specific Norwegian conditions have been identified regarding properties of the genetically modified maize DP51291, VKM's GMO panel has not performed a complete risk assessment of the maize. (...)

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The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of soy leghemoglobin produced from genetically modified Komagataella phaffii for food uses in the EU. In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation. The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law. Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation. In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during scientific hearings initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission. The assignment is divided into three stages. Soy leghemoglobin produced from genetically modified Komagataella phaffii This application is submitted to gain authorisation for the use of soy leghemoglobin (the liquid preparation is referred to as “LegH Prep”) produced from genetically modified Komagataella phaffii (yeast) as a flavouring (“meaty taste”) in meat analogue products that will be marketed in the European Union (EU). Soy leghemoglobin is intended for addition to meat analogue products that are for use in foods such as burgers, meatballs, and sausages. Komagataella phaffii-strain employed in the production of soy leghemoglobin contains genetic modifications which allow it to express this protein. Following fermentation, the cells are lysed, and the soy leghemoglobin is concentrated by physical means. The soy leghemoglobin is delivered in a liquid preparation (LegH Prep) that is standardised to contain up to 9% soy leghemoglobin on a wet weight basis and a soy leghemoglobin protein purity of at least 65%. The remainder of the protein fraction in the LegH Prep is accounted for by residual proteins from the Komagataella phaffii production strain. These residual proteins are all endogenous to Komagataella phaffii as the gene coding for the expression of soy leghemoglobin is the only gene from a different organism. VKM has assessed the documentation in application EFSA-GMO- NL-2019-162 and EFSA's scientific opinion for the use of soy leghemoglobin produced from genetically modified Komagataella phaffii. The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified microorganisms for use in food or feed. The VKM GMO Panel does not consider leghemoglobin from genetically modified Komagataella phaffii to imply potential specific health risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment was not performed by VKM. About the assignment: (...)