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

Abstract

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.

Targeting a coatomer protein complex-I gene via RNA interference results in effective lethality in the pollen beetle Brassicogethes aeneus

“…While current restrictions prevent the implementation of this technology within EU countries, this could change with further experience with the technology, and understanding of its impacts (e.g. after refinements are made to RNAi risk assessments) (Arpaia et al 2020). There may also be the possibility to apply appropriately timed dsRNA-based spray treatments to effectively manage B. aeneus.…”

RNAi-Mediated Suppression of Laccase2 Impairs Cuticle Tanning and Molting in the Cotton Boll Weevil (Anthonomus grandis)

“…Further studies should be performed to explore the feasibility of RNAi pest control approaches, such as transgenic cotton plants expressing ds AgraLac2 into the nuclear or the plastid genome as well as engineered fungi, bacteria, and virus expressing ds AgraLac2 or ds AgraLac2 complexed with nanoparticles as a dsRNA delivery method for foliar application on cotton leaves. Importantly, for field applications, the impact of RNAi-based pest control technologies to non-target organisms and environment needs to be cautiously assessed before they can be safely used on crops ( Arpaia et al, 2020 ; Bachman et al, 2020 ; Mezzetti et al, 2020 ; Romeis and Widmer, 2020 ). Consequently, future approaches relying on AgraLac2 dsRNA to control A. grandis will require a comprehensive risk assessment to ensure their biosafety.…”

Trans-kingdom RNAs and their fates in recipient cells: advances, utilization, and perspectives

“…Bioinformatics can help to minimize potential off-target effects and reveal potential risks. Nonetheless, the risk assessment process should be flexible, and decisions should be made on a case-by-case basis ( Arpaia et al., 2020 ).…”

“…Various aspects of trans-kingdom RNAs have been summarized in detail, including the challenges and triumphs of trans-kingdom RNA in agricultural applications ( Liu et al., 2020b ; Das and Sherif, 2020 ), the biosafety of plant-expressed dsRNA ( Arpaia et al., 2020 ), and the potential for use of trans-kingdom RNA in the treatment of human diseases ( Gorabi et al., 2020 ; Hu et al., 2020 ). Here, we raise the fascinating question of the fate of trans-kingdom RNAs in the recipient cell.…”