Technical Report

TR 107 – Addendum to ECETOC Targeted Risk Assessment Technical Report No. 93

TR 107 : Addendum to ECETOC Targeted Risk Assessment Technical Report No. 93 | December 2009

The ECETOC targeted risk assessment (TRA) Task Force reported in 2004 (Technical Report No. 93), and launched the supporting web-based TRA tool shortly after. Since 2004, almost 2000 users have registered with ECETOC to gain an access to the tool and benefit from its abilities. As part of the process for maintaining the integrity and relevance of the TRA approach, ECETOC has also 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.

The TRA Task Force was re-convened in 2006 to review the current basis for the approach and make recommendations for further improvements. The Task Force?s interim recommendations for how a future version of the TRA might be structured were delivered to the Scientific Committee in 2007 and were subsequently scoped in terms of the work effort required to integrate them into an updated version of the TRA tool. The new version is based on an Excel format and is available to download from the ECETOC TRA website. At the same time, the value of the TRA was recognised 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. At the same time, the Task Force recognised the need to develop a more workable and pragmatic approach to environmental risk assessment using the principles laid down within the EUSES (European Union system for the evaluation of substances) model.

Since the summer of 2007, ECETOC has continued its dialogue with stakeholders and notably the Commission / European Chemicals Agency (ECHA). Many of the ideas outlined in the August 2007 Scoping Document are now incorporated into the planned ECHA CSA/CSR tool (Chesar). Furthermore, as the specification for the CSA/CSR tool foresees integrating the use of several elements of the TRA exposure estimation models, the TRA Task Force has 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. This report describes the current structure of the revised TRA approach (for workers, consumers and the environment), details the nature of the changes from the original TRA and describes the process of justification/verification where such changes are substantive.