On 20 October 2020, the Working Group “Exposure Models” of the Europe Regional Chapter of the International Society of Exposure Science (ISES Europe) organised an online workshop to discuss the theoretical background of models for the assessment of occupational exposure to chemicals. In this report, participants of the workshop with an active role before and during the workshop summarise the most relevant discussion points and conclusions of this well-attended workshop. ISES Europe has identified exposure modelling as one priority area for the strategic development of exposure science in Europe in the coming years. This specific workshop aimed to discuss the main challenges in developing, validating, and using occupational-exposure models for regulatory purposes. The theoretical background, application domain, and limitations of different modelling approaches were presented and discussed, focusing on empirical “modifying-factor” or “mass-balance-based” approaches. During the discussions, these approaches were compared and analysed. Possibilities to address the discussed challenges could be a validation study involving alternative modelling approaches. The wider discussion touched upon the close relationship between modelling and monitoring and the need for better linkage of the methods and the need for common monitoring databases that include data on model parameters.
Model tools for estimating hazardous substance exposure are an accepted part of regulatory risk assessments in Europe, and models underpin control banding tools used to help manage chemicals in workplaces. Of necessity the models are simplified abstractions of real-life working situations that aim to capture the essence of the scenario to give estimates of actual exposures with an appropriate margin of safety. The basis for existing inhalation exposure assessment tools has recently been discussed by some scientists who have argued for the use of more complex models. In our opinion, the currently accepted tools are documented to be the most robust way for workplace health and safety practitioners and others to estimate inhalation exposure. However, we recognise that it is important to continue the scientific development of exposure modelling to further elaborate and improve the existing methodologies.
1 October 2015 in Regulatory Toxicology and Pharmacology
This paper explores the usefulness of the exposure database MEGA for model validation and evaluates the capability of two Stoffenmanager model equations (i.e. handling of powders/granules and machining) to estimate workers exposure to inhalable dust. For the task groups, ‘handling of powders and granules’ (handling) and ‘machining of wood and stone’ (machining) measurements were selected from MEGA and grouped in scenarios depending on task, product, and control measures. The predictive capability of the model was tested by calculating the relative bias of the single measurements and the correlation between geometric means (GMs) for scenarios. The conservatism of the model was evaluated by checking if the percentage of measurement values above the 90th percentile estimate was ≤10%. From 22 596 personal measurements on inhalable dust within MEGA, 390 could be selected for handling and 1133 for machining. The relative bias for the task groups was −25 and 68%, respectively, the percentage of measurements with a higher result than the estimated 90th percentile 11 and 7%. Correlations on a scenario level were good for both model equations as well for the GM (handling: rs = 0.90, n = 15 scenarios; machining: rs = 0.84, n = 22 scenarios) as for the 90th percentile (handling: rs = 0.79; machining: rs = 0.76). The MEGA database could be used for model validation, although the presented analyses have learned that improvements in the database are necessary for modelling purposes in the future. For a substantial amount of data, contextual information on exposure determinants in addition to basic core information is stored in this database. The relative low bias, the good correlation, and the level of conservatism of the tested model show that the Stoffenmanager can be regarded as a useful Tier 1 model for the Registration, Evaluation, Authorisation and Restriction of Chemicals legislation.
1 September 2021 in International Journal of Hygiene and Environmental Health
In this article, we have responded to the key statements in the article by Koivisto et al. (2022) that were incorrect and considered to be a biased critique on a subset of the exposure models used in Europe (i.e. ART and Stoffenmanager®) used for regulatory exposure assessment. We welcome scientific discussions on exposure modelling (as was done during the ISES Europe workshop) and criticism based on scientific evidence to contribute to the advancement of occupational exposure estimation tools. The tiered approach to risk assessment allows various exposure assessment models from screening tools (control/hazard banding) through to higher-tiered approaches. There is a place for every type of model, but we do need to recognize the cost and data requirements of highly bespoke assessments. That is why model developers have taken pragmatic approaches to develop tools for exposure assessments based on imperfect data. We encourage Koivisto et al. to focus on further scientifically robust work to develop mass-balance models and by independent external validations studies, compare these models with alternative model tools such as ART and Stoffenmanager®.