Evolution of the TRA
The ECETOC Targeted Risk Assessment (TRA) tool was launched in 2004. The TRA consists of 3 separate models for estimating exposures to workers, consumers and the environment. The general concept of the TRA is based on the premise that, by making suitably conservative assumptions, broad exposure/risk models with low levels of data input requirements can be applied to determine where any further detailed assessment of risks may be required. Therefore, although the different TRA models utilise different algorithms and assumptions, efficiencies are introduced into the process of exposure and risk assessment through the ability of the TRA to utilise common exposure determinant information across the models.
REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union. One of the key challenges of REACH is that it envisages the registration and evaluation of approximately 30,000 chemicals by producers and importers. Many of these chemicals will be classified and will require Chemical Safety Assessments (assessments of the risks to man and the environment presented by the manufacture and use of the substance) to support their registration. Faced with such a challenge, both practically and scientifically, suitable tools that are accessible to non-experts are a key need of the REACH process.
The value of the TRA was recognised in 2006 under the European Commission’s REACH RIP 3.2 stakeholder review activity on the development of chemical safety assessments. Specifically, the TRA was seen to be the preferred approach for evaluating worker health risks (at the Tier 1 level) and having the potential for also being adopted for evaluating consumer health risks. The TRA Tool has had a major beneficial impact on REACH – there was no other way chemical safety assessments (CSAs) could be compiled without it. More than 80% of the CSAs submitted in the first two rounds of REACH registrations have been based on the TRA.
July 2009: Launch of TRAv2
Following further discussions with stakeholders, and notably the European Commission and European Chemicals Agency (ECHA), ECETOC released version 2 of the TRA in 2009. This ensured that the TRA fully aligned with the expectations contained in Chapters R12-R16 of the Technical Guidance on Information Requirements and Chemicals Safety Assessment (IR&CSA). In particular, ECETOC worked to develop improved exposure estimation models for workers, consumers and the environment that continue to carry forward the principles that were pioneered in the original TRA web tool whilst accommodating many helpful suggestions from the stakeholder process. The general success of the TRA concept is witnessed such that by the end of 2011, over 10,000 downloads of the version2 of the TRA have been made.
In addition, ECETOC authored a scoping document that outlined how the process of chemicals risk assessment could be improved, in order that the outputs from CSAs are understandable and can be readily assimilated within the systems for safe use communication e.g. safety data sheets. Many of the ideas outlined in the 2007 Scoping Document have now been incorporated into the ECHA CSA/CSR tool (Chesar).
Following the completion of Phase 1 of REACH in December 2010, ECETOC approached users of the TRA to seek their ideas for how the TRA might be further improved. The aim of this exercise was to ensure that key learnings could be captured and suitable improvements incorporated, if necessary, into an updated version that would be available for use in Phase 2 of REACH. The intention was not to radically overhaul the TRA. Rather, within its existing framework, it sought to further improve its accuracy and flexibility, while eliminating any identified anomalies.
March 2010: ECETOC announce the launch of the 2010 version of the TRA Tools
Subsequent to the release of the TRAv2 in July 2009, ECETOC held a series of meetings and events with experts from member companies and regulatory authorities with the aim of identifying what further modifications may be either necessary or beneficial. While the science underlying the ECETOC Targeted Risk Assessment remained unchanged, ECETOC revised certain aspects of the TRA Tool in order to:
- take into account the latest development of the REACH Guidance Chapters R12, R14, R15, and R16
- respond to the users’ feedback and to implement the full functionality of the tools.
Changes: The major changes in the individual tools are:
Worker tool (standalone version): revised version (debugged version) Environment assessment (integrated tool): revised version (debugged version) a comprehensive list of SPERCs has been implemented in order to facilitate refined assessments:
- the emissions from wide dispersive uses are now summed up Consumer assessment (standalone and integrated)
- the revised use descriptor system has been implemented, together with associated Product sub Categories and related exposure determinants
April 2012: Version 3 of the Targeted Risk Assessment (TRA) Tool
In April 2012, ECETOC launched version 3 of the Targeted Risk Assessment (TRA) Tool together with updated user guides. TRAv3 is available in two forms: as an integrated exposure/risk assessment tool covering worker, consumer and environmental exposures; and as a standalone consumer exposure estimation tool. Both forms of the TRA are downloadable from the TRA website without charge, together with their supporting user guides. It is not ECETOC‘s intention to support a standalone worker version 3 of the tool. Technical Report No. 114 details the full technical basis for version 3. The technical basis for TRA v1 and TRA v2 remains accessible via the Technical Reports 93 and 107. ECETOC has been working with the European Chemicals Agency (ECHA) as part of its work activities associated with the delivery of a revised version of the Chesar Chemical Safety Assessment tool (http://chesar.echa.europa.eu/). The new version of Chesar was released in June 2012 and is intended to directly reflect version 3 of the TRA for both worker and consumer exposures. Furthermore, Chesar v2 allows the incorporation of the Specific Environmental Release Categories (SpERCs) that are included as a key element of the environmental component of the TRA v3.
June 2014: TRA Tool update to TRAv3.1
In response to feedback received from users of the TRA, ECETOC further improved the consumer portion of the model by the inclusion of the ability to account for infrequent uses of consumer products. The changes which were developed in cooperation with ECHA are now found as version 3.1 of the TRA and are also to be found within version 2.3 of Chesar (Link to Chesar website).
Version 3.1 is available both as an integrated model and a standalone version for the consumer part, and together with updated user guides can now be downloaded from this webpage. A detailed explanation of the rationale for the changes is contained in Technical Report 124: Addendum to ECETOC TR114: Technical Basis for the TRA v3.1 which provides further clarification of how ECETOC has applied ‘transfer factors’ in the TRA’s prediction of oral, dermal and inhalation exposures. These improvements now enable the information contained within developments such as the DUCC Specific Consumer Exposure Determinants (http://www.ducc.eu/Activities.aspx ) to be suitably processed.
The update to version 3.1 was used as an occasion to include an updated SpERC list and improvements of the functionalities by offering the export and import of single substance datasets.