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Future needs, list of items and ranking
Jane Richardson, DATA Unit
TG IUCLID PESTICIDE meeting
17-18 June 2020
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Outline
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Objective
Proposed work items
Discussion
Towards a roadmap for IUCLID for pesticides
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The MVP describes the IUCLID solution for March 2021. Howeverthere have been requests to provide information on the longer-term planning for the project.
The following work items come from discussions and issuesencountered during the pilot and project phase to date.
The purpose of this presentation will be to identify gaps (issomething missing?) and start the prioritization of workitems (star items which are really important) to facilitate thedevelopment of a roadmap for pesticide submissions in IUCLIDbeyond March 2021
Objective
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Missing
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IUCLID for National Authorisations –data matching, equivalence checks, national/zonal, mutual recognition, zonal authorisation changes
Efficacy Section 6 product data requirements OHT 88 not sufficient
Expo
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Traceability and life cycle of the dossier (Both)
Defining and managing the ‘regulatory action’ as an ordered sequence of step for dossiers with same subject
Versioning dossier (validation, assessment, updated, commenting, published, peer review version, final, renewal)
Versioning of evaluation reports /conclusions and linking to the dossier version
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Renewal dossiers (Transmission)
Matching / controlling reference substances between dossiers
Defining and implementing requirements for renewal dossier aggregation algorithms
Maintaining confidentiality and features to promote and facilitate data sharing between applicants
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Annotations for evaluators (Evaluation)
Format changes to facilitate the work of evaluators
Search function for annotations
Grouping, versioning of annotations and previous evaluation flag
Inclusion of annotation information in DAR/RAR (including selection of specific annotations)
Improvements for ease of use and speed of completion
Feature to allow approval by a senior evaluator
Section overviews - reports of all evaluation information for specific sections or sub-chapter, completeness indicators and KPIs
Need for attachments or images of charts/tables linked to an expert evaluation
Validated endpoints
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Endpoint study records (Both)
Adaptation of OHTs or creation of new documents for higher tier studies and studies in the pipeline but without agreed testing standards
Examples Toxicity to birds and bees
Aged sorption studies
Residues in honey, pollen and bee products
Magnitude and metabolism of residues in fish
Ecotoxicology mesocosm studies
Mechanistic toxicology studies
Endocrine disrupters
Adaptation of OHTs or creation of new documents considering requirements coming from the OECD biopesticides group and DG SANTE data requirements revision for micro-organisms
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Report generator (Evaluator)
Lists Document L & Volume 2 (List of studies)
Few study types Vol 3 (Data on application)
Vol 3 (Methods)
Vol 3 (Precautionary measures)
Vol 3 (Efficacy)
Adaption from other regulations Vol 3 (Identity + Function)
Vol 3 (Phys-chem and Technical characteristics)
Vol 3 (Toxicology and Metabolism)
Vol 3 (Fate in the Environment)
Vol 3 (Ecotoxicology)
Documents M
* Reporting is format dependant
Pesticides specific Vol 3 (Residues and MRL)
Combining sections Evaluation report MRL
Documents N & LoEP
Volume 4 (Confidential)
Draft evaluation report (DAR)
Renewal evaluation report (RAR)
Summaries of all results of studies supervised residue trials
experimental conditions and DT50 values (parent and breakdown products)
ecotox/tox endpoints (parent/metabolite/impurity, species, timescale, conditions)
endpoints by analytical method
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Confidentiality and filtering (Transmission)
Enhancements to the format of dissemination preview (product, substance, metabolite, impurity)
Analysis of need for features for processing free text fields
Sanitisation of evaluation reports
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Validation Assistant (Both)
Within document completeness checks specific for pesticides (REACH checks are included in MVP)
Data requirement checks for documents dependant on information in other documents e.g. Supervised residue trial studies are provided for crops listed in GAP document
Specific checks for metabolite/impurity datasets
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Integration with Local Systems (Evaluator)
Records management features (storage of legally binding documents)
EFSA notification of studies database
Public consultation and commenting tables (outside of IUCLID) (linking to dossier and evaluation reports)
EFSA workflow for confidentiality assessments
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Interoperabilty (Evaluator)
Exchange of information and metabolic profiles between IUCLID and MetaPath
EU - Pesticides database– existing MRLs (https://ec.europa.eu/food/plant/pesticides/eu-pesticides-
database/public/?event=homepage&language=EN)
RUEDIS
Updating EPPO lists
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Risk assessment – Summaries/Calculators (Evaluator)
Primo https://doi.org/10.5281/zenodo.2620033
PROFilehttps://doi.org/10.5281/zenodo.159163
OPEX https://doi.org/10.5281/zenodo.161298
OECD 106https://doi.org/10.5281/zenodo.2874728
EFSA DegT50 Endpoint Selector https://doi.org/10.5281/zenodo.166259
Bee-Tool https://doi.org/10.5281/zenodo.56669
EU Animal burden calculator https://doi.org/10.5281/zenodo.827275
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Transport of result level data (Both)
Concentrations of active substance / metabolites / residues / breakdown products in plants / animal tissues / air / water/ soil
Clinical observations in humans / mammals / ecotox species
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Cross dossier data extraction (Evaluator)
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Additional PPP ECHA Tools – IUCLID Uploader
• Additional tools to support PPP are under review. These are NOT part of the MVP but are based on under development tools of ECHA
• IUCLID Uploader• Vision: a tool that extracts chemical data
from different data sources, curates and imports (uploads) it into IUCLID
• Analyse how different data sources (Fraunhofer DB, Hess DB, ToxRefDB) can be mapped to IUCLID
• KNIME based prototype: uploader workflowwill consist of reusable IUCLID nodes and a data-source specific node
• Custom implementation will be required for each data-source
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Thanks for your attention!