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2026

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Sammendrag

The Norwegian Environment Agency has tasked The Norwegian Scientific Committee for Food and Environment (VKM) with developing generic guidance documents for environmental risk assessment of genetically modified organisms (GMOs) to be used in field trials. GMOs used in limited field trials may have effect on the environment, and human and animal health. All experiments involving the use of GMOs in field trails for research require approval under the Norwegian Gene Technology Act. The Norwegian Environment Agency is the decision-making authority for deliberate release of GM plants in field trials. VKM performs health and environmental risk assessments (ERAs) of GMOs for the Norwegian Environment Agency. This guidance document is intended as a support for applicants seeking approval for field trials under the Gene Technology Act and identifies the scientific documentation and data necessary to facilitate an ERA of a genetically modified animal (GM animal) conducted by VKM. The risk assessments conducted by VKM generally follow the step-by-step approach outlined in EU Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment, starting with hazard identification, hazard characterization, exposure characterization and risk characterization. The Gene Technology Act and the Regulations on impact assessment under the Gene Technology Act implements directive 2001/18/EC into Norwegian legislation. Appendix 2 of the Regulation contain the principles for environmental risk assessment, which corresponds to the principles of Annex II in the Directive. The European Food Safety Authority (EFSA) has developed further guidance on the risk assessment of genetically modified organisms based on Annex II. ERAs of GM animals involve the collection, assessment and, where appropriate, generation of information on a GM animal to determine its potential impacts on the environment and on human and animal health, compared with non-GM animals or appropriate comparators. VKM performs risk assessments that include the following six steps: hazard identification, hazard characterisation, exposure characterisation, risk characterisation, risk reducing measures, and overall risk evaluation of the use of the GM animal in a field trial. Applicants should identify the scientific documentation and data necessary for VKM to perform an ERA based on these steps. Applicants should also consider general risk reducing measures in relation to the identified risks, taking into consideration the type of GM animal, the intended management regime (confinement), the scale of the field trial, the characteristics of the genetic modification, the characteristics of the identified hazard(s), and the potential consequences for the environment and for human and animal health. This document provides guidance for the assessment of the potential environmental effects of GM animals, based on data from the required molecular characterisation, consideration of the potential impacts of the modified characteristics of the GM animal, and any risk mitigating measures implemented in the event of escape of GM animals into the environment during field trials. The guidance is intended as a dynamic document to be amended in accordance with future scientific and regulatory developments.

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Sammendrag

Warming‐driven intensification of the hydrological cycle is altering global rainfall patterns. However, the relative importance of changes in the amount versus timing of rainfall and the role of atmospheric drivers of moisture demand in modifying relationships between rainfall, biodiversity and ecosystem functioning are currently unresolved. To address this, we undertook a 10‐year rainfall manipulation experiment in a mesic grassland in New South Wales, Australia. We used rain shelters to achieve five rainfall treatments: (i) ambient, (ii) ambient +50% (IA), (iii) ambient −50% (RA), (iv) reduced frequency (RF, cumulative ambient rainfall applied once every 3 weeks) and (v) summer drought (SD, no rain during the Austral summer). We found that inter‐annual variation in ANPP was best explained by the amount of growing season rainfall relative to potential evapotranspiration (i.e., P/PET, or aridity) (R 2 adj 0.52). Reductions in the amount of rainfall, particularly during summer, were associated with productivity decline, shifts in community composition and a loss of diversity. However, reducing the frequency of rain events had no overall effect on productivity, despite a loss of species diversity. Notably, treatment‐related declines in diversity and/or richness were associated with both increases (IA) and decreases (SD) in temporal stability of ANPP and the stabilising role of species asynchrony, thereby highlighting the importance of species identity and associated functional traits for community stability. Our study uniquely emphasises the importance of accounting for seasonal drivers of moisture demand when predicting functional responses to changes in rainfall regimes and highlights how the ecological mechanisms underpinning community stability are influenced by changes in both the amount and timing of rainfall. These mechanistic insights can enhance the predictive capacity of Earth system models and inform targeted management strategies to offset the negative effects of future, more extreme rainfall on the ecosystem services provided by global grasslands.