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Exposure models are essential for a range of contexts involving exposure science. The Exposure Models Working Group, established under ISES Europe, identified that to improve model use, suitable training and education is required. However, there is currently no formal educational training programme for exposure modelling in Europe. We present results from an online survey disseminated to the European exposure science community to identify modelling training needs. The questionnaire had three sections: background information about the respondents and interests in exposure science, previous attendance of exposure modelling courses, interest in future training and education in exposure modelling and their coverage and format.A total of 88 survey recipients completed the survey. Most respondents were from governmental organizations (36 %), with 50 % of all respondents having less than 10 years of experience. About two-thirds of the respondents stated that they had previously attended exposure modelling courses. These were mostly focused on specific models, up to one day in duration and took place in-person. Two thirds of respondents expressed interest in attending future exposure modelling training modules, with the most important topics being interpretation of model results and use of models to meet regulatory standards/requirements. Preferred attendance of training courses was virtual or blended. Costs and certificates of attendance seemed less influential when selecting a training course. Our survey suggests that there is a demand for training in exposure modelling and provides insight to inform the development of training modules that are suitable to fulfil the training needs of exposure scientists and practitioners.

Exposure to manufactured nanomaterials (MNs) is a growing concern for occupational health and safety. Reliable methods for assessing and predicting MN exposure are essential to mitigate associated risks. This study presents the development of the Nano Exposure Quantifier (NEQ), a mechanistic model designed to assess airborne MN exposure in the workplace. By utilizing a dataset of 128 MN measurements from existing exposure studies, the model demonstrates its effectiveness in estimating MN exposure levels for particles smaller than 10 µm. The NEQ provides estimates in terms of particle number concentration accompanied by a 95% confidence interval (CI), enabling a comprehensive assessment of MN exposure. The NEQ includes 2 quantitative models: a simplified tier 1 model and a more comprehensive tier 2 model. Both tier 1 and tier 2 models exhibit robust performance, with correlation coefficients (r) of 0.57 and 0.62, respectively. The models exhibit a moderate level of error, as indicated by residuals' standard deviation of 4.10 for tier 1 and 3.90 for tier 2. The tier 1 model demonstrates a slightly higher overestimation bias (1.15) compared to the tier 2 model (0.54). Overall, the NEQ offers a practical and reliable approach for estimating MN exposure in occupational settings. Future validation studies will investigate the impact of initial calibration efforts, heteroscedasticity, and further refine the model's accuracy., (© The Author(s) 2025. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.)

This article describes the development of a Safe-by-Design (SbD) module and its integration into an easy-to-use tool, named the Nano Exposure Quantifier-Safe-by-Design (NEQ-SbD) tool. The NEQ-SbD tool guides its user to lower the exposure to nanomaterials at the worksite where nanomaterials are manipulated or handled during a wide range of activities. This allows the tool user with an informed decision to assess airborne exposure and to select, compare, and identify appropriate risk management measures (RMM). The SbD module was developed using various information sources that can support and guide the SbD process, including the (i) RMM effectiveness based on analyses of an Exposure Control Efficacy Library (ECEL), (ii) RMM performance using a Computational Fluid Dynamics (CFD) model, (iii) e-cards based on a qualitative analysis of RMM information sources, and (iv) guidance for SbD strategy using an exposure directionality assessment. This information has been integrated in the user interface of the SbD module and NEQ-SbD tool to facilitate the SbD decision-making process. The SbD concept applied in the integrated NEQ-SbD tool introduces a comparison between a baseline exposure assessment and an (improved) SbD exposure assessment. The integrated NEQ-SbD tool consists of 4 modules including (i) a baseline exposure assessment, (ii) baseline results, (iii) SbD assessment, and (iv) SbD comparative results. The main purpose of the SbD module lies in guiding the user to the most sensitive (exposure) parameters and allowing a side-by-side comparison of potentially suitable RMMs. The integrated NEQ-SbD tool also offers a tiered approach and seamlessly shifts from a tier-1 to tier-2 uncertainty of an exposure assessment. The SbD module is illustrated using a worked example for the transfer of nano powders, showing the possibility of identifying SbD solutions for both safe-by-process and safe-by-material design purposes. The NEQ-SbD tool is a valuable tool for the SbD of nanomaterials and as a decision-making tool to support SbD risk management strategies that lead to minimizing health risks associated with occupational exposures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Occupational Hygiene Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The past few decades of managing the uncertain risks associated with nanomaterials have provided valuable insights (knowledge gaps, tools, methods, etc.) that are equally important to promote safe and sustainable development and use of advanced materials. Based on these insights, the current paper proposes several actions to optimize the risk and sustainability governance of advanced materials. We emphasise the importance of establishing a European approach for risk and sustainability governance of advanced materials as soon as possible to keep up with the pace of innovation and to manage uncertainty among regulators, industry, SMEs and the public, regarding potential risks and impacts of advanced materials. Coordination of safe and sustainable advanced material research efforts, and data management according to the Findable, Accessible, Interoperable and Reusable (FAIR) principles will enhance the generation of regulatory-relevant knowledge. This knowledge is crucial to identify whether current regulatory standardised and harmonised test methods are adequate to assess advanced materials. At the same time, there is urgent need for responsible innovation beyond regulatory compliance which can be promoted through the Safe and Sustainable Innovation Approach. that combines the Safe and Sustainable by Design concept with Regulatory Preparedness, supported by a trusted environment. We further recommend consolidating all efforts and networks related to the risk and sustainability governance of advanced materials in a single, easy-to-use digital portal. Given the anticipated complexity and tremendous efforts required, we identified the need of establishing an organisational structure dedicated to aligning the fast technological developments in advanced materials with proper risk and sustainability governance. Involvement of multiple stakeholders in a trusted environment ensures a coordinated effort towards the safe and sustainable development, production, and use of advanced materials. The existing infrastructures and network of experts involved in the governance of nanomaterials would form a solid foundation for such an organisational structure., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Background and Objectives: This paper describes an evaluation and analysis of an updated version of ECEL v3.0-an integrated risk management measure (RMM) library developed as part of a CEFIC LRI initiative. The occupational module contains extensive data on the quantitative effectiveness of RMMs to control inhalation and dermal exposure in the workplace. The objective was to investigate the effectiveness and variability in effectiveness of RMM and to explore the difference between optimal and non-optimal RMM applications in the workplace., Methods: A new database structure and interface were developed and the content of the database was updated with a systematic literature review and integration with other databases (totalling 3373 records from 548 studies). To analyse the data, Bayesian linear mixed models were constructed with the study as a random effect and various study characteristics and RMM categories as fixed effects individually in separate models. A multivariate mixed model was used on a stratified dataset to test (amongst others) the conditions of RMM use., Results: Analyses of the data indicated effectiveness values for each RMM category (for example ~87% for technical emission controls compared with ~60% for technical dispersion controls). Substantial variability in effectiveness was observed within and between different types of RMM. Seven study characteristics (covariables) were included in the analyses, which indicated a pronounced difference in as-built (optimal/experimental) and as-used (workplace) conditions of RMM use (93.3% and 74.6%, respectively)., Conclusions: This library provides a reliable evidence base to derive base estimates of RMM effectiveness-beneficial for both registrant and downstream users. It stresses the importance of optimal use of RMMs in the workplace (technical design/functioning, use, and maintenance). Various challenges are foreseen to further update ECEL to improve guidance, for deriving improved estimates and ensure user-friendliness of the library., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Occupational Hygiene Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Several exposure assessment models use dustiness as an input parameter for scaling or estimating exposure during powder handling. Use of different dustiness methods will result in considerable differences in the dustiness values as they are based on different emission generation principles. EN17199:2019 offers 4 different dustiness test methods considering different dust release scenarios (e.g. powder pouring, mixing and gentle agitation, and vibration). Conceptually, the dustiness value by a given method can be multiplied with a scenario-specific modifier, called a handling energy factor (Hi), that allows conversion of a dustiness value to a release constant. Therefore, a Hi, scaling the effective mechanical energy in the process to the energy supplied in the specific dustiness test, needs to be applied. To improve the accuracy in predictive exposure modelling, we derived experimental Hi to be used in exposure algorithms considering both the mass- and number-based dust release fraction determined by the EN17199-3 continuous drop (CD) and the EN17199-4 small rotating drum (SRD) test methods. Three materials were used to evaluate the relationship between dustiness and dust levels during pouring powder from different heights in a controlled environment. The results showed increasing scatter and difference between the Hi derived for the 2 test methods with increasing pouring height. Nearly all the Hi values obtained for both SRD and CD were <1 indicating that the dustiness tests involved more energy input than the simulated pouring activity and consequently de-agglomeration and dust generation were higher. This effect was most pronounced in CD method showing that SRD mechanistically resembles more closely the powder pouring., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.)

Biobanks are important in biomedical and public health research, and future healthcare research relies on their strength and capacity. However, there are financial challenges related to the operation of commercial biobanks and concerns around the commercialization of biobanks. Non-commercial biobanks depend on grant funding to operate and could be valuable to researchers if they can enable access to quality specimens at lower costs. The objective of this study is to estimate the value of specific biobank attributes. We used a rating-based conjoint experiment approach to study how researchers valued handling fee, access, quality, characterization, breadth of consent, access to key endemics, and time taken to fulfil requests. We found that researchers placed the greatest relative importance on the quality of specimens (26%), followed by the characterization of specimens (21%). Researchers with prior experience purchasing biological samples also valued access to key endemic in-country sites (11.6%) and low handling fees (5.5%) in biobanks., (© 2023. The Author(s).)

A roadmap was developed to strengthen standardisation activities for risk governance of nanotechnology. Its baseline is the available standardised and harmonised methods for nanotechnology developed by the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), and the Organisation for Economic Co-operation and Development (OECD). In order to identify improvements and needs for new themes in standardisation work, an analysis of the state-of-the-art concepts and interpretations of risk governance of nanotechnology was performed. Eleven overall areas of action were identified, each including a subset of specific topics. Themes addressed include physical chemical characterisation, assessment of hazard, exposure, risk and socio-economic factors, as well as education & training and social dialogue. This has been visualised in a standardisation roadmap spanning a timeframe of ten years and including key outcomes and highlights of the analysis. Furthermore, the roadmap indicates potential areas of action for harmonisation and standardisation (H&S) for nanomaterials and nanotechnology. It also includes an evaluation of the current level (limited, moderate, intense) of ongoing H&S activities and indicates the time horizon for the different areas of action. As the identified areas differ in their state of development, the number and type of actions varied widely amongst the different actions towards achieving standardisation. Thus, priority areas were also identified. The overall objective of these actions is to strengthen risk governance towards a safe use of nanomaterials and nano-related products. Though not explicitly addressed, risk-based legislation and policies are supported via the proposed H&S actions., Competing Interests: Declaration of Competing Interest The authors declare no competing interests., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

There has been an increasing use of advanced materials, particularly manufactured nanomaterials, in industrial applications and consumer products in the last two decades. It has instigated concerns about the sustainability, in particular, risks and uncertainties regarding the interactions of the manufactured nanomaterials with humans and the environment. Consequently, significant resources in Europe and beyond have been invested into the development of tools and methods to support risk mitigation and risk management, and thus facilitate the research and innovation process of manufactured nanomaterials. The level of risk analysis is increasing, including assessment of socio-economic impacts, and sustainability aspects, moving from a conventional risk-based approach to a wider safety-and-sustainability-by-design perspective. Despite these efforts on tools and methods development, the level of awareness and use of most of such tools and methods by stakeholders is still limited. Issues of regulatory compliance and acceptance, reliability and trust, user-friendliness and compatibility with the users' needs are some of the factors which have been traditionally known to hinder their widespread use. Therefore, a framework is presented to quantify the readiness of different tools and methods towards their wider regulatory acceptance and downstream use by different stakeholders. The framework diagnoses barriers which hinder regulatory acceptance and wider usability of a tool/method based on their Transparency, Reliability, Accessibility, Applicability and Completeness (TRAAC framework). Each TRAAC pillar consists of criteria which help in evaluating the overall quality of the tools and methods for their (i) compatibility with regulatory frameworks and (ii) usefulness and usability for end-users, through a calculated TRAAC score based on the assessment. Fourteen tools and methods were assessed using the TRAAC framework as proof-of-concept and for user variability testing. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework. The framework could be, in principle, adapted and extended to the evaluation of other type of tools & methods, even beyond the case of nanomaterials., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: Within the chemical legislation, REACH was implemented in order to improve safe working conditions with hazardous substances. Literature and real-life experiences by those concerned have shown that there are still gaps with a need for improved risk communication. This study elaborated on how information provided by REACH is understood and acted on by down- and upstream users, and how it can be further improved., Methods: An extensive literature study including 21 studies and 13 tools was carried out. The outcomes were discussed and further supplemented by means of 18 interviews concerning 37 internal safety and REACH documents to build six different use cases representing different Dutch downstream companies. For the upstream perspective also 2 sector organizations and 2 registrants were interviewed. Three online workshops were organized in order to share insights and gather input on international recognition, potential suggestions and further recommendations with 30 participants from nine different EU countries., Results: Although the methods to collect the data differed between the different stages of the study, the general results from all three stages elucidated similar themes in the data and each of the stages used the results from the previous stage as a starting point. Recurring themes concerned the (i) complexity of documents, (ii) deficiencies as experienced by SMEs in REACH, (iii) feedback and responsibilities in the supply chain, and (iv) the cooperation between REACH and OSH., Discussion: The study at hand revealed that even though there are currently several activities to improve communication on safe-use of chemicals, communication on safe-use in the scope of REACH should be improved. This includes e.g. the future involvement of actual end-users in activities and development related to communication of safe-use information in the scope of REACH including feedback, less complicated and complex documents and clear communication concerning legislations and updates of documents. Furthermore, the issues recognized in the Netherlands are mostly also recognized by international workshop participants, thereby indicating international benefits in various areas by means of improved communication., Conclusions: The study confirmed that many of our generic conclusions were already part of the shared knowledge in the REACH community, but that it is very valuable that this knowledge has been explicated, validated and reported in a structured way in the present project. Besides uncovering some crucial aspects that offer potential improvements regarding risk communication, this study offers possible solutions and next steps to be taken., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.)

Exposure models are essential in almost all relevant contexts for exposure science. To address the numerous challenges and gaps that exist, exposure modelling is one of the priority areas of the European Exposure Science Strategy developed by the European Chapter of the International Society of Exposure Science (ISES Europe). A strategy was developed for the priority area of exposure modelling in Europe with four strategic objectives. These objectives are (1) improvement of models and tools, (2) development of new methodologies and support for understudied fields, (3) improvement of model use and (4) regulatory needs for modelling. In a bottom-up approach, exposure modellers from different European countries and institutions who are active in the fields of occupational, population and environmental exposure science pooled their expertise under the umbrella of the ISES Europe Working Group on exposure models. This working group assessed the state-of-the-art of exposure modelling in Europe by developing an inventory of exposure models used in Europe and reviewing the existing literature on pitfalls for exposure modelling, in order to identify crucial modelling-related strategy elements. Decisive actions were defined for ISES Europe stakeholders, including collecting available models and accompanying information in a living document curated and published by ISES Europe, as well as a long-term goal of developing a best-practices handbook. Alongside these actions, recommendations were developed and addressed to stakeholders outside of ISES Europe. Four strategic objectives were identified with an associated action plan and roadmap for the implementation of the European Exposure Science Strategy for exposure modelling. This strategic plan will foster a common understanding of modelling-related methodology, terminology and future research in Europe, and have a broader impact on strategic considerations globally., (© 2022. The Author(s).)