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 a request from the European Commission related to the prolongation of prohibition of the placing on the market of genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape GT73. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape GT73 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import, processing and feed uses of oilseed rape GT73 in the EU pose a significant and imminent risk to the environment. The EFSA GMO Panel does not consider the occurrence of occasional feral oilseed rape GT73 plants, pollen dispersal and consequent cross-pollination as environmental harm in itself. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73

Scientific Opinion on a request from the European Commission for the assessment of the new scientific elements supporting the prolongation of prohibition of the placing on the market of maize MON 863 for food and feed purposes in Austria

Austria notified the European Commission of its new scientific elements justifying the prolongation for three additional years of the implementation of a national safeguard measure prohibiting the placing on the market of genetically modified maize MON 863 in Austria. Subsequently, the European Commission asked the European Food Safety Authority (EFSA) to assess the new scientific information supporting the prolongation of the prohibition. Having considered the information provided by Austria and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that the new scientific elements submitted by the Austrian Authorities do not lead EFSA to reconsider the conclusions in its opinions on maize MON 863

Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations for the cultivation of the genetically modified insect resistant maize Bt11 and MON 810

The EFSA GMO Panel was asked by the European Commission to apply its mathematical model to simulate and assess potential adverse effects resulting from the exposure of non-target Lepidoptera to maize Bt11 or MON 810 pollen under hypothetical agricultural conditions, and to provide information on the factors affecting the insect resistance management plan, additional to that in its 2011 Statement supplementing the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize Bt11 for cultivation. Here, risk managers are provided with additional evidence and further clarifications to those previous conclusions and risk management recommendations. This Scientific Opinion provides background scientific information to inform the decision-making process; the EFSA GMO Panel reiterates that risk managers should choose risk mitigation and management measures that are proportionate to the level of identified risk according to the protection goals pertaining to their regions

Statement supplementing the environmental risk assessment conclusions and risk management recommendations on genetically modified insect-resistant maize 59122 for cultivation in the light of new scientific information on non-target organisms and regionally sensitive areas

Following a request from the European Food Safety Authority (EFSA), the Panel on Genetically Modified Organisms (GMO Panel) was asked to supplement its environmental risk assessment conclusions and risk management recommendations on maize 59122 for cultivation in the light of new scientific information on non-target organisms and regionally sensitive areas. Having considered additional information relevant to the assessment of potential adverse effects of maize 59122 on non-target organisms, the Panel must revise two of its previous environmental risk assessment conclusions, invalidating its earlier statement on the environmental safety of maize 59122 in its 2013 Scientific Opinion. A gap in the event-specific data on the honeybee study performed by Maggi (2001) was identified, as a result of which uncertainty over the occurrence of adverse effects on pollinators due to potential unintended changes in maize 59122 remains. Therefore, the Panel is no longer in a position to complete its assessment on the occurrence of adverse effects on pollinators. The Panel reassessed the available dataset on ladybirds, including the Califf and Ostrem (2009) study, and considers the latter study does not enable resolving the remaining scientific uncertainty on the potential toxicity of the binary Cry34Ab1/Cry35Ab1 proteins on Coccinella septempunctata or other ladybirds. In both cases, the Panel recommends that an additional laboratory study is performed prior to authorisation. The Panel considered regionally sensitive areas in its assessment, but regards it as premature to recommend specific risk management strategies for susceptible insect species potentially found within and nearby such areas owing to the inconclusive nature of the assessment of potential adverse effects of maize 59122 on non-target organism