Periodic Reporting for period 2 - RATION (Risk AssessmenT InnOvatioN for low-risk pesticides)
Berichtszeitraum: 2024-05-01 bis 2025-10-31
Potential low-risk pesticides (LRP) like plant extracts, semiochemicals, pheromones, microbials, and ds-RNA are coming to replace synthetic ones globally. But EU lacks a specific risk assessment scheme, hindering their market uptake. RATION aims to develop risk assessment schemes and tools tailored to LRPs. This multi-partner effort targets regulatory barriers and aims to accelerate plant protection innovation.
The Stakeholder Forum (StaFo) counts of nearly 100 members with 6 workshops performed. Task forces destined for microbials, botanicals and ds-RNA were established for a more regular interaction with StaFo members. Formulated questionnaires probed into the hurdles faced by national authorities in assessing both active substances and products. Highlights of the questionnaires were (a) the understaffing of most MS regulatory bodies (ii) the lack of personnel with specific knowledge to undertake the risk assessment of LRP (iii) the perception of MS that risk assessment of LRP is more demanding compared to synthetic ones. A report examining current risk assessment procedures per LRP, shedding light on updates, revisions, and ongoing recommendations was prepared. A comparative analysis with US and EU market requirements was included revealing discrepancies in data requirements and test methodologies.
Regarding microbial pesticides, three products (bacteria, fungi, virus) were used as models. The main achievements are:
(i) ecotox testing protocols for aquatic and terrestrial organisms for model microbials have been performed and pitfalls were identified
(ii) A whole genome sequencing (WGS) tool was developed to support risk assessment of microbial pesticides. This addresses pathogenicity, antimicrobial resistance traits and biosynthetic pathways for toxic metabolites. This open tool provides a comprehensive output compared to MOPS (EFSA tool) and it will be supported by training sessions.
(iii) A new risk assessment scheme for microbials based on a combination of decision trees and pathways to harm is under development
(iv) suggestions and guidance on the risk assessment of microbial consortia of different complexity, phages and protists have been produced
Delving into the regulatory landscape of plant extracts and pheromones, thorough reviews and analyses of areas of concern were conducted. Problem formulation based on these products were established and a new risk assessment approach is under development based on decision trees and pathways to harm. Experiments have focused on different model products including single compound botanicals (dihydrochalcone, pelargonic acid), and complex plant extracts (Reynoutria japonica) offering a more challenging risk assessment where advanced analytical approaches are used.
dsRNA for target genes (PSMB5, actin and gfp) were synthesized targeting Colorado potato beetle. Naked and formulated dsRNA was tested. A bioinformatic tool for the prediction of potential undesirable effects on NTOs was developed, and identified NTOs potentially affected by dsRNA. Testing with selected NTOs is on-going. Methods to determine the persistence of dsRNA in soil and plants were established. The data derived are used in mathematical models for predicting dsRNA e-fate. A risk assessment approach combining decision tree and pathways to harm is under development.
Harmonized RA among different LRP groups is under development, fed by the work in microbials, natural products and ds-RNA. Survey with 3600 consumers in Europe was undertaken and results are currently analyzed.
Project partners have participated in several dissemination and networking activities, and 10 papers published. This will continue to improve communication with relevant parties through the website and the digital channels of the project
Regarding microbial pesticides, three products (bacteria, fungi, virus) were used as models. The main achievements are:
(i) ecotox testing protocols for aquatic and terrestrial organisms for model microbials have been performed and pitfalls were identified
(ii) A whole genome sequencing (WGS) tool was developed to support risk assessment of microbial pesticides. This addresses pathogenicity, antimicrobial resistance traits and biosynthetic pathways for toxic metabolites. This open tool provides a comprehensive output compared to MOPS (EFSA tool) and it will be supported by training sessions.
(iii) A new risk assessment scheme for microbials based on a combination of decision trees and pathways to harm is under development
(iv) suggestions and guidance on the risk assessment of microbial consortia of different complexity, phages and protists have been produced
Delving into the regulatory landscape of plant extracts and pheromones, thorough reviews and analyses of areas of concern were conducted. Problem formulation based on these products were established and a new risk assessment approach is under development based on decision trees and pathways to harm. Experiments have focused on different model products including single compound botanicals (dihydrochalcone, pelargonic acid), and complex plant extracts (Reynoutria japonica) offering a more challenging risk assessment where advanced analytical approaches are used.
dsRNA for target genes (PSMB5, actin and gfp) were synthesized targeting Colorado potato beetle. Naked and formulated dsRNA was tested. A bioinformatic tool for the prediction of potential undesirable effects on NTOs was developed, and identified NTOs potentially affected by dsRNA. Testing with selected NTOs is on-going. Methods to determine the persistence of dsRNA in soil and plants were established. The data derived are used in mathematical models for predicting dsRNA e-fate. A risk assessment approach combining decision tree and pathways to harm is under development.
Harmonized RA among different LRP groups is under development, fed by the work in microbials, natural products and ds-RNA. Survey with 3600 consumers in Europe was undertaken and results are currently analyzed.
Project partners have participated in several dissemination and networking activities, and 10 papers published. This will continue to improve communication with relevant parties through the website and the digital channels of the project
It is envisaged that StaFo will act as an arena of interaction that brings together all relevant sectors of LRPs; more effort is needed to attract representatives from the general public and farmers associations. The first EU-wide survey focusing on MS regulatory bodies was undertaken. It highlighted deficiencies at the regulatory process for LPRs and steps that will facilitate innovation in the market uptake of LRPs. A comprehensive summary of the current regulatory status of LRPs and a comparison with frameworks in other jurisdictions was prepared.
Highlights on microbial pesticides inlcude (i) development and validation of a WGS analysis tool for decision-making regarding pathogenicity, AMR and secondary metabolites for microbials overcoming deficiencies of MoPS; multiple training sessions will be organized in RP3; the tool also includes fungal toxins, not available in MoPS (ii) the consortium in collaboration with EUSO and JRC got access to the LUCAS 2018 soil samples and it will use them to determine the background levels of microorganisms used as PPPs in Europe via metagenomics and targeted q-PCR
Highlights on botanicals and semiochemicals/pheromones include (a) review of common areas of concern regarding botanical pesticides, ways of addressing including novel ecotoxicological testing approaches were explored (b) advanced MS methods are used to address the complexity of plant extracts used as pesticides using Reynoutria japonica as a model extract; guidance on how to address this complexity at risk assessment level is required
Highlights on ds-RNA pesticides include (a) development of a novel bioinformatic tool for assessing potential effects of dsRNA molecules on NTOs according to genomic and transcriptomic data of surrogate and non surrogate NTOs (b) methods for the determination of dsRNA levels in soils and plants were developed; chitosan formulation significantly prolongs the persistence of dsRNA in soil (c) the effects of dsRNA on the soil microbiota is under scrutiny using advanced molecular tools, (d) mathematical models to predict exposure to dsRNA are under testing
A harmonized risk assessment scheme is under development fed by the RA approaches developed for microbials, botanicals and ds-RNA. The market survey with 3600 people participating was undertaken and results are currently analyzed and they will be used to analyze the socio-economic effects of the risk assessment of LRP.
Highlights on microbial pesticides inlcude (i) development and validation of a WGS analysis tool for decision-making regarding pathogenicity, AMR and secondary metabolites for microbials overcoming deficiencies of MoPS; multiple training sessions will be organized in RP3; the tool also includes fungal toxins, not available in MoPS (ii) the consortium in collaboration with EUSO and JRC got access to the LUCAS 2018 soil samples and it will use them to determine the background levels of microorganisms used as PPPs in Europe via metagenomics and targeted q-PCR
Highlights on botanicals and semiochemicals/pheromones include (a) review of common areas of concern regarding botanical pesticides, ways of addressing including novel ecotoxicological testing approaches were explored (b) advanced MS methods are used to address the complexity of plant extracts used as pesticides using Reynoutria japonica as a model extract; guidance on how to address this complexity at risk assessment level is required
Highlights on ds-RNA pesticides include (a) development of a novel bioinformatic tool for assessing potential effects of dsRNA molecules on NTOs according to genomic and transcriptomic data of surrogate and non surrogate NTOs (b) methods for the determination of dsRNA levels in soils and plants were developed; chitosan formulation significantly prolongs the persistence of dsRNA in soil (c) the effects of dsRNA on the soil microbiota is under scrutiny using advanced molecular tools, (d) mathematical models to predict exposure to dsRNA are under testing
A harmonized risk assessment scheme is under development fed by the RA approaches developed for microbials, botanicals and ds-RNA. The market survey with 3600 people participating was undertaken and results are currently analyzed and they will be used to analyze the socio-economic effects of the risk assessment of LRP.