RNA-based biocontrol compounds:Current status and perspectives to reach the market

Facing current climate challenges and drastically reduced chemical options for plant protection, the exploitation of RNA interference (RNAi) as an agricultural biotechnology tool has unveiled possible new solutions to the global problems of agricultural losses caused by pests and other biotic and abiotic stresses. While the use of RNAi as a tool in agriculture is still limited to a few transgenic crops, and only adopted in restricted parts of the world, scientists and industry are already seeking innovations in leveraging and exploiting the potential of RNAi in the form of RNA-based biocontrol compounds for external applications. Here, we highlight the expanding research and development pipeline, commercial landscape and regulatory environment surrounding the pursuit of RNA-based biocontrol compounds with improved environmental profiles. The commitments of well-established agrochemical companies to invest in research endeavours and the role of start-up companies are crucial for the successful development of practical applications for these compounds. Additionally, the availability of standardized guidelines to tackle regulatory ambiguities surrounding RNA-based biocontrol compounds will help to facilitate the entire commercialization process. Finally, communication to create awareness and public acceptance will be key to the deployment of these compounds. © 2019 Society of Chemical Industry

Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing 1, and for the renewal of authorisation of existing products produced from cotton MON 159852, both under Regulation (EC) No 1829/2003 from Monsanto

Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria

Statement on a request from the European Commission related to the emergency measure notified by Bulgaria on genetically modified maize MON 810 according to Article 34 of Regulation (EC) 1829/2003

Following a request of the European Commission, the European Food Safety Authority (EFSA) evaluated the concerns raised by Bulgaria and the accompanying documentation submitted under Article 34 of Regulation (EC) 1829/2003 in support of its request to prohibit the cultivation of the genetically modified maize MON 810 in the European Union. EFSA concludes that neither the arguments put forward by Bulgaria nor the documentation reveal new scientific evidence, in terms of risk to human and animal health or the environment, that would support the adoption of an emergency measure on the cultivation of maize MON 810 under Article 34 of Regulation (EC) 1829/2003. In the absence of new relevant scientific evidence, EFSA concludes that its previous risk assessment conclusions and risk management recommendations on maize MON 810 and those of its GMO Panel remain valid and applicable

Scientific Opinion on a notification (reference C/NL/09/02) for the placing on the market of the genetically modified carnation IFD-26407-2 with a modified colour, for import of cut flowers for ornamental use, under Part C of Directive 2001/18/EC from Florigene

Genetically modified (GM) carnation IFD-26407-2 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-26407-2 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-26407-2. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-26407-2 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment

Statement complementing the EFSA opinion on application EFSA GMO UK 2007 41 (cotton MON 88913 for food and feed uses, import and processing) taking into consideration updated bioinformatic analyses

In this statement, the EFSA GMO Panel responds to a request from the European Commission (EC) to complement its partially inconclusive scientific opinion on cotton MON 88913 taking into consideration updated bioinformatic analyses submitted by the applicant after the adoption. Similarity searches assessed the identity of the genomic sequences flanking the MON 88913 insert, the potential of creating open reading frames (ORFs) showing similarity to known allergens or toxins and the similarity of the newly expressed CP4 EPSPS protein to known allergens or toxins. Having assessed these searches, the EFSA GMO Panel did not identify interruptions of known cotton genes or any safety issue arising from the identified ORFs including the newly expressed CP4 EPSPS protein. In conclusion, the EFSA GMO Panel considers that cotton MON 88913, as assessed in the scientific opinion on application EFSA-GMO-UK-2007-41 and in the supplementary bioinformatic dataset, is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses

Scientific Opinion on application (EFSA-GMO-NL-2010-77) for the placing on the market of herbicide-tolerant genetically modified cotton GHB614 LLCotton25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience

Cotton GHB614 × LLCotton25 was produced by conventional crossing. The EFSA GMO Panel previously assessed the two single cotton events GHB614 and LLCotton25 and did not identify safety concerns. Integrity of the inserts was retained in the two-event stack cotton. No differences requiring further food and feed safety assessment were identified in the compositional analysis of cotton GHB614 × LLCotton25 except for a higher level of gossypol. The EFSA GMO Panel further assessed this difference and considers that it is of no safety relevance for animals and humans. Expression analysis and safety assessment of the newly expressed proteins identified no concerns regarding their potential toxicity and allergenicity. No indications of safety issues regarding the overall allergenicity of cotton GHB614 × LLCotton25 were identified. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering the scope of the application, potential interactions of cotton GHB614 × LLCotton25 with the biotic and abiotic environment were not considered a relevant issue. Environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton GHB614 × LLCotton25 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25