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: Introducing Environmental Relevance into Environmental Risk Assessment
This TP was developed in 2015 to address the complexity and variability in Risk Assessment by improving ecological relevance and so enable better risk mitigation and risk management.
The programme comprises 3 key elements:
- 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
Programme 3: Targeted Risk Assessment
Since the introduction of the TRA in 2004, many 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 supported the TRA via a help facility and has described its technical basis in ECETOC Technical Reports TR93 (2004), TR107 (2009), TR114 (2012) and TR124 (2014).
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.
ECETOC Technical Report no.131: Targeted Risk Assessment: Further Explanation of the Technical Basis of the TRA v3.1 was published in February 2018 and can be downloaded from https://goo.gl/D56cyh
The TR addresses many of the technical questions that either ECETOC or ECHA have received since 2014 and for which further clarification was thought to be either needed or useful.
Subgroup: Worker Targeted Risk Assessment
The Task Force is currently reviewing a series of external validation studies on worker exposure estimations using the ECETOC TRA tool, version 3.
Publications such as the BAuA-sponsored E-team work are included in this review phase.
The objectives are to:
- Assess where some elements in the TRA are inaccurate
- Provide input and ensure alignment with the ENES Action 3.2 group (led by ECHA)
- Harvest new insights from current LRI projects [LRI B15.3; B19.2; B20].
The group is also in contact with a number of academics and regulators to engage them as external advisors.
Subgroup: Consumer Targeted Risk Assessment
The Task Force is currently working to
- Provide a peer-review manuscript on infrequent and/or short-duration exposure estimates to bring clarity and align risk assessors on a science-based approach
- Develop a manuscript evaluating the conservativeness of the TRA-consumer module.
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 expects to continue to consult with the TEGs on relevant technical aspects, though has also recently circulated a market survey for scientific services to support the update of EUSES.
The Environment branch of the TRA Task Force will continue to liaise with ECHA and the TEGs. Diederik Schowanek (P&G), Paul Mason (SC Johnson), as well as Lucy Wilmot (ECETOC), continue as members of ECHA’s EUSES update Steering Committee
Programme 4: Development of an Integrated Approach for Chemicals Assessment
This new Transformational Programme emerged during the Human Health Scoping meeting which took place in February 2018. The meeting raised concerns regarding the limitations and constraints of the current regulatory framework.
Chemicals have many uses which are of great benefit to society. A regulatory system has evolved over the past 50 years that enables the use of chemicals without causing harm to people.
The regulatory system does not currently allow new approach methodology 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.
A small team from the ECETOC Scientific Committee has been set up to work on drafting a concept that will first present and analyse our current system for assessing hazard, exposure and the current rules for classification and risk characterisation.
It will then develop a series of proposals (or actions that could be addressed) to increase the efficiency of the process, allowing more chemicals and uses to be assessed and allowing aggregate and cumulative exposure assessments to be made.
The team has recently been in dialogue with external stakeholders to seek interest and exchange thoughts (for example, recent discussions with the EC Joint Research Centre, as well as the European Crop Protection Association were very positive).
The next step is to test the concept with examples, looking at one sector first, to explain and show regulators how it would work in practice.