Future needs, list of items and ranking

Jane Richardson, DATA Unit

TG IUCLID PESTICIDE meeting

17-18 June 2020

Outline

2

Objective

Proposed work items

Discussion

Towards a roadmap for IUCLID for pesticides

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

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

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

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

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

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

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

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

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

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

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

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

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!