Article Open Access
refereed
published

Biosafety of GM crop plants expressing dsRNA: Data requirements and EU regulatory considerations

Affiliation
ENEA, Italian National Agency for New Technologies, Energy and Sustainable Economic Development, Rotondella, Italy
Arpaia, Salvatore;
Affiliation
Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium
Christiaens, Olivier;
Affiliation
Bayer, Crop Science R&D Regulatory Science, Chesterfield, MO, United States
Giddings, Kara;
Affiliation
Translational Genomics for Plant Breeding, Aberystwyth University, Wales, United Kingdom
Jones, Huw;
Affiliation
Department of Agricultural, Food and Environmental Sciences, Università Politecnica delle Marche, Ancona, Italy,
Mezzetti, Bruno;
Affiliation
Regulatory Sciences, ICGEB, Trieste, Italy
Moronta-Barrios, Felix;
Affiliation
Oaklands Barn, Norfolk, United Kingdom
Perry, Joe N.;
Affiliation
JT Environmental Consultants Ltd, Cambridge, United Kingdom
Sweet, Jeremy B.;
Affiliation
Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium
Taning, Clauvis N. T.;
Affiliation
Department of Plants and Crops, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium
Smagghe, Guy;
GND
1058992457
Affiliation
Julius Kühn-Institut (JKI), Institute for Biosafety in Plant Biotechnology, Germany
Dietz-Pfeilstetter, Antje

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 via 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.

Files

Cite

Citation style:
Could not load citation form.

Access Statistic

Total:
Downloads:
Abtractviews:
Last 12 Month:
Downloads:
Abtractviews:

Rights

Use and reproduction: