10-12 April 2019 OECD, Paris
WHAT'S NEW: The OECD released a second Working Document on Considerations for the Human Health Risk Assessment of Externally Applied ds-RNA-Based Pesticides (No.110) in June 2023.
The OECD Conference on RNAi based pesticides provided an overview on the current status and future possibilities for the regulation of externally applied dsRNA-based products that are proposed for use as pesticides. The event facilitated exchanges between policy makers, academia, industry on their implications in health, environment, and regulation.
The focus on regulatory needs and aspects of risk assessment also aimed at informing the use of public and government funds in support of research on the use of externally applied dsRNA in agricultural agencies and institutes.
Finally, hearing from regulatory authorities that have reviewed dsRNA-based crop traits helped informing regulatory policies at the national and international level and facilitate the development of a harmonised approach for regulating externally applied dsRNA-based plant protection products.
The Conference not only provided an overview but also inputs and recommendations for guidance(s) to be developed by the Working Group on Pesticides (WGP) and especially by its Expert Group working on RNAi-based pesticides. The first document developed by the group is the Working Document on Considerations for the Environmental Risk Assessment of the Application of Sprayed or Externally Applied ds-RNA-Based Pesticides (No. 104) that was released in September 2020. This document provides a broad set of recommendations relating to risk assessment considerations for exogenously-applied dsRNA-based products, with a focus on issues relating to data requirements for determining the environmental fate of sprayable RNA molecules and for examining the potential risks to non-target organisms. This document is intended to provide an overview of available scientific information related to RNA interference (RNAi), and considerations on regulating this technology for pest control.
The second Working Document on Considerations for the Human Health Risk Assessment of Externally Applied ds-RNA-Based Pesticides (No.110), released in June 2023, includes the lessons learned from the application of this technology in the field of pharmaceuticals and considers a range of issues directly relevant to human exposure arising from the application of externally-applied dsRNA-based pesticides, and discusses possible effects of dsRNA exposure in mammals.
The full proceedings of the conference on “Regulation of Externally Applied dsRNA-based Products for Management of Pests” with papers prepared subsequently by each of the speakers, are published online and can be downloaded at Frontiers Research Topic RNAi Based Pesticides. The conference report summarises input from presenters and Conference participants during the panel discussions at the end of each session. Key considerations from these discussions have already been incorporated into the OECD Working Document.
SESSION 1: Summary of the State of the Art: dsRNA based Product Use in Agriculture
The first session provided a background on the molecular mechanism of RNAi and relevant related pathways, reviewed the current understanding of cross-kingdom RNAi, examined the species-specificity of these dsRNAs on non-target species and discussed challenges related to the RNAi-efficiency in insects.
The second session dealt with the research to date that investigated the factors that affect insects’ responsiveness to environmental dsRNA, covered approaches to assess biodegradation of dsRNA in different matrices and explored the role of certain technology to predict genetic changes and the impact in terms of efficacy of the RNAi products in target pests. It also summarised the published literature related to dietary uptake of external dsRNA in humans and addressed the lessons learnt from human therapeutic use of dsRNA.
SESSION 2: Summary of Regulatory & Risk Assessment Experience with dsRNA-based Products
The third and final session focused on how problem formulation can guide risk assessments for spray applications of pesticides containing dsRNA, and considered potential pathways and testable risk hypotheses in the context of environmental risk assessment. It also covered the experience of experts involved in the risk assessment of genetically-modified crop plants, which incorporate the machinery to synthesise RNA molecules specifically directed against a pest species feeding on the crop (so-called ‘plant-incorporated protectants’, or PIPs).
This project has been produced with the financial assistance of the European Union. The views expressed herein can in no way be taken to reflect the official opinion of the European Union.
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