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Frontiers in plant science
2020;11 940.

Biosafety of GM Crop Plants Expressing dsRNA: Data Requirements and EU Regulatory Considerations.

Salvatore Arpaia, Olivier Christiaens, Kara Giddings, Huw Jones, Bruno Mezzetti, Felix Moronta-Barrios, Joe N Perry, Jeremy B Sweet, Clauvis N T Taning, Guy Smagghe, Antje Dietz-Pfeilstetter
Author Information
  1. Salvatore Arpaia: ENEA, Italian National Agency for New Technologies, Energy and Sustainable Economic Development, Rotondella, Italy.
  2. Olivier Christiaens: Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.
  3. Kara Giddings: Bayer, Crop Science R&D Regulatory Science, Chesterfield, MO, United States.
  4. Huw Jones: Translational Genomics for Plant Breeding, Aberystwyth University, Wales, United Kingdom.
  5. Bruno Mezzetti: Department of Agricultural, Food and Environmental Sciences, Università Politecnica delle Marche, Ancona, Italy.
  6. Felix Moronta-Barrios: Regulatory Sciences, ICGEB, Trieste, Italy.
  7. Joe N Perry: Oaklands Barn, Norfolk, United Kingdom.
  8. Jeremy B Sweet: JT Environmental Consultants Ltd, Cambridge, United Kingdom.
  9. Clauvis N T Taning: Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.
  10. Guy Smagghe: Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.
  11. Antje Dietz-Pfeilstetter: Institute for Biosafety in Plant Biotechnology, Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Braunschweig, Germany.
PMID: 32670333 DOI: 10.3389/fpls.2020.00940

Abstract

The use of RNA interference (RNAi) enables the silencing of target genes in plants or plant-dwelling organisms, through the production of double stranded RNA (dsRNA) resulting in altered plant characteristics. Expression of properly synthesized dsRNAs in plants can lead to improved crop quality characteristics or exploit new mechanisms with activity against plant pests and pathogens. Genetically modified (GM) crops exhibiting resistance to viruses or insects expression of dsRNA have received authorization for cultivation outside Europe. Some products derived from RNAi plants have received a favourable opinion from the European Food Safety Authority (EFSA) for import and processing in the European Union (EU). The authorization process in the EU requires applicants to produce a risk assessment considering food/feed and environmental safety aspects of living organisms or their derived food and feed products. The present paper discusses the main aspects of the safety assessment (comparative assessment, molecular characterization, toxicological assessment, nutritional assessment, gene transfer, interaction with target and non-target organisms) for GM plants expressing dsRNA, according to the guidelines of EFSA. Food/feed safety assessment of products from RNAi plants is expected to be simplified, in the light of the consideration that no novel proteins are produced. Therefore, some of the data requirements for risk assessment do not apply to these cases, and the comparative compositional analysis becomes the main source of evidence for food/feed safety of RNAi plants. During environmental risk assessment, the analysis of dsRNA expression levels of the GM trait, and the data concerning the observable effects on non-target organisms (NTO) will provide the necessary evidence for ensuring safety of species exposed to RNAi plants. Bioinformatics may provide support to risk assessment by selecting target gene sequences with low similarity to the genome of NTOs possibly exposed to dsRNA. The analysis of these topics in risk assessment indicates that the science-based regulatory process in Europe is considered to be applicable to GM RNAi plants, therefore the evaluation of their safety can be effectively conducted without further modifications. Outcomes from the present paper offer suggestions for consideration in future updates of the EFSA Guidance documents on risk assessment of GM organisms.

Keywords

GMO regulation RNA interference bioinformatics biosafety food safety genetically modified plants non-target organisms

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