Transformational Programmes

As part of the ECETOC Board’s decision to devote part of its resources to thought leadership, ECETOC has established a set of Transformational Programmes (TP), with 3-5 year timespans, addressing topics of longer-term scientific relevance which have the potential to transform chemicals management.

Four Transformational Programmes are underway:

Programme 1: Using Molecular Data Wisely

ECETOC’s first Transformational Programme ‘Applying ‘omics technologies in chemicals risk assessment’ was initiated by the 2014 Human Health Scoping & Review Meeting. The TP responds to a growing need to understand how to get the best value out of the increasing generation of large volumes of ‘omics data. The Programme aims to enhance the acceptance and establishment of standardised practices (in the context of Good Laboratory Practice), as well as to create processes and guidelines that provide confidence for regulators and registrants to interpret and apply ‘omics data in regulatory decision-making.

Cefic LRI projects currently underway as part of this TP are:

• LRI C4: Transcriptomics bioinformatics best practices in Toxicogenomics for regulatory application;
• LRI C5: XOMETOX – Evaluating multi-omics integration for assessing rodent thyroid toxicity;
• LRI C6: Toxicogenomic approaches to support read-across; and
• LRI C7: ELUMICA – Elucidating Microbial Metabolic Capacity.

Programme 2: Implementation of new methodologies in environmental risk assessment​

This programme is about to launch – watch this space for more information!

If you’re interested in getting involved in this activity, please get in contact!

Programme 3: Targeted Risk Assessment

Since the introduction of the TRA in 2004, thousands of users have downloaded the tool and its supporting technical guidance from the ECETOC website. In addition to the guidance contained in the tool’s User Guide, ECETOC has described its technical basis in ECETOC Technical Reports TR93 (2004), TR107 (2009), TR114 (2012) and TR124 (2014) and TR131 (2018) – all reports are available here.

Since 2010, the worker and consumer modules of the TRA have been used as the basis for estimating human exposures to chemicals within ECHA’s Chesar Chemical Safety Assessment (CSA) tool.

Subgroup: Worker Targeted Risk Assessment

This Task Force was establish to review a series of external validation studies on worker exposure estimations using the ECETOC TRA tool, with the aim to assess whether there are any inconsistencies .

ECETOC Technical report no. 140 Systematic review of published studies of ECETOC TRA Worker exposure predictions was published in May 2022, describing the gaps identified in the external studies, as well as variable quality of data. The report but concluded that the tool remains suitable for estimating inhalation exposure when preparing REACH dossiers for chemical substances. The full report can be downloaded here.

The Task Force is currently working on the preparation of a second report based on the review of studies for dermal exposure. The report is expected to be released in spring 2023.

Subgroup: Consumer Targeted Risk Assessment

This Task Force has been working on a manuscript evaluating the conservativeness of the TRA-consumer module. The manuscript was submitted to the Journal of Exposure Science and Environmental Epidemiology and is currently undergoing a review process.

Subgroup: Environment Targeted Risk Assessment

In the first half of 2019, ECETOC coordinated industry’s contribution to the first stage (IT feasibility study) of the ECHA EUSES update process. This was done via a series of ECHA-organised Technical Expert Groups (TEGs) with industry delegates and industry stakeholder groups.

Towards the end of 2019, ECHA confirmed it intended to develop a common chemical risk assessment tool for REACH and biocides (combining EUSES and Chesar) in early 2020.

ECHA is continuing to consult with the TEGs on relevant technical aspects and the Environment branch of the TRA Task Force remains engaged.

The Task Force is also working on:

  • A literature review on assessment of humans exposed indirectly via the environment, to ascertain the state of the science and identify further research needs. This will be conducted by a consultant, with the Task Force acting as a Steering Group.
  • A collaboration project with National Institute for Public Health and the Environment in The Netherlands (RIVM) and Environment and Climate Change Canada (ECCC) relating to generation of removal predictions from the SimpleTreat model (an assessment tool for the fate of substances in waste water treatment plants, incorporated into EUSES and Chesar) and comparisons to measured removal data. This stepped from some ongoing work by ECCC to improve waste water treatment removal modelling. The OECD Working Party on Exposure Assessment (WPEA) has been kept informed of this activity.

 

Programme 4: Development of an Integrated Approach for Chemicals Assessment

This Transformational Programme emerged during the Human Health Scoping meeting which took place in February 2018.

Chemicals have many uses which are of great benefit to society. Over the past 50 years, the regulatory system that enables the use of chemicals without causing harm to people has significantly evolved. Yet, it does not currently allow new approach methodologies to be used in the assessment of toxicity.

ECETOC believes that much of the technology which is required to provide a 21st century regulatory system for chemicals (including pesticides and biocides) already exists, but that it requires a new framework.

The team has worked on a concept paper to present and analyse our current system for assessing hazard, exposure and the current rules for classification and risk characterisation. The paper called ‘A framework for chemical safety assessment incorporating new approach methodologies within REACH’ was published in the journal Archives of Toxicology and can be downloaded here. The team has been in dialogue with external stakeholders (such as JRC and ECHA) to seek interest and exchange thoughts.

The next steps include the formation of two new Task Forces to work on:

  • exemplifying the staged assessment process by using it to provide more information in low tonnage bands, working with the current classification system as far as possible.
  • examining how in vivo studies considered to be preliminary or screening within REACH could be refined provide more information by the inclusion of additional elements such as “omics”.