Transformational Programmes

ECETOC is currently running 4 Transformational Programmes:

1. Using molecular data wisely for decision making

The Programme: Using Molecular Data Wisely responds to a growing need to understand how to get the best value out of the increasing generation of large volumes of ‘omics’ data. Currently, there is no guidance on how to produce, store or interpret omics data in the regulatory context. Principles for a common path forward should be established so regulators can have confidence in using omics data for better decision-making and standard operating procedures based on best practice for each technology will ensure consistent application in laboratories. With this in mind, ECETOC has developed a tripartite Transformational Programme:

1 / Establish a set of principles for data production and storage in a standardised and GLP-like way in order to ensure similar paths and principles are adhered to across multiple laboratories.

2 / Establish a framework on how to analyse omics data, starting with transcriptomics. Expert Meetings during 2015 resulted in a draft framework.

3 / Develop a weight of evidence approach that assesses transparency, consistency and vulnerability to bias to aid risk assessors make scientific judgements on how to apply ‘omics data to risk assessment. Achieving our goals would set quality criteria to ensure data quality, reproducibility and confidence in decision making. It could help facilitate regulatory acceptance of data from new technologies whilst protecting against interpretation of poor data, developed lacking the quality standards.

2. Introducing environmental relevance into Environmental Risk Assessment

Addressing complexity and variability in RA by improving ecological relevance to enable better risk mitigation and risk management. The large degree of temporal and spatial variability in ecological communities and environmental exposures requires that the current assessment approaches and models be enhanced.

Addresses 3 work streams…

  • Assessing the effects of chemicals in ecological communities
  • Exposure science for higher tier risk assessment
  • Ecosystem service-based approaches for landscape scale risk assessment and risk management

3. Globalising the concepts used in the ECETOC Targeted Risk Assessment Tool (TRA)

The TRA Tool is used widely in chemical risk assessment in Europe to undertake Tier 1 exposure assessments.   This transformational programme is designed to sustain and broaden the use of the TRA within Europe and beyond by improving the confidence in the utility of the tool.

It contains 3 work streams:

    • Meet Industry and ECHA expectations
    • Internationalisation opportunities
    • Reinforce reputation and brand recognition

4. An Integrated Approach for Precision based Risk Assessment in the 21st Century (Transformational Programme)

This topic has emerged from the 2018 Human Health Scoping meeting. A small team from the ECETOC Scientific Committee has been set up for drafting a concept for a new system. The concept first presents and analyses our current system for assessing hazard, exposure and the current rules for classification and risk characterisation. Secondly and most importantly this new concept develops a series of proposals (or actions that could be addressed) which would increase the efficiency of the process allowing more chemicals and uses to be assessed and allowing aggregate and cumulative exposure assessments to be made.