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Potential users of Safe and Sustainable by Design (SSbD) approaches, in particular small and medium sized enterprises, struggle to find their way in the sheer amount of existing knowledge, testing methods and tools. To better guide them in making decisions throughout their entire design process of advanced nanomaterials, a user-friendly online intelligent SSbD Decision Support System (DSS) is developed within the HARMLESS project. Previous experience and stakeholder analysis is used to integrate existing as well as numerous newly generated NAM-based data & models and integrated approaches to testing and assessment (IATAs) into a unified HARMLESS SSbD framework. We propose a modular approach in which all data, knowledge and models are captured in stand-alone, interconnected FAIR components. HARMLESS will A) use eNanoMapper as a database to store experimental data, B) launch a new FAIR Data Point to capture all knowledge and decision rules, C) launch a novel Model FAIRpoint with runnable algorithms and D) launch a new Decision Support System interface. The DSS interface connects to the HARMLESS FAIR components, but can also connect to external components (e.g. NanoCommons Data Warehouse, Jaqpot, NanoInformaTIX). The decision support process is based on a well-established concept of Risk Informed Decision Making adopted by NASA and US NRC, based on the fusion of deterministic and probabilistic risk assessment. To this end, Bayesian network modelling is used to integrate existing and new knowledge, data and models into an integrative reasoning model that captures uncertainty. This information is presented in an interactive visualization presenting an overview of all important decision criteria augmented with SSbD advice allowing the user to interactively work with the tool to improve their design. Oral presentation, by Wouter Fransmann (TNO), at the nanoSAFE 2023 Conference (5-9.06.2023, Grenoble, France) on 6th June 2023-Session:Methods, Tools, & Technologies for SSbD Purposes

There has been an increasing use of manufactured nanomaterials in industrial applications and consumer products. It has instigated concerns about the sustainability, risks and uncertainties regarding the interactions of the nanomaterials with humans and the environment. Consequently, significant resources in Europe have been invested into tool and method development to support risk mitigation and management, facilitating the research and innovation process of manufactured nanomaterials. Extended risk analysis, including socio-economic impact and sustainability assessment is moving the conventional risk-based approach towards a wider safety-and-sustainability-by-design perspective. Despite growing tool and method developments, the level of awareness and use by stakeholders is still limited. Regulatory compliance and acceptance, reliability and trust, user-friendliness and compatibility with the users’ needs are important factors 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, developed within Gov4Nano, diagnoses barriers which hinder regulatory acceptance and wider usability of a tool/method based on their Transparency, Reliability, Accessibility, Applicability and Completeness (TRAAC framework). An online TRAAC tool is being developed within HARMLESS that will be freely available on https://diamonds.tno.nl/#traac. Fourteen tools and methods were assessed using the TRAAC framework as proof-of-concept. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework.

Risk governance, sustainability and safety-by-design have high attention in current research projects and policy. In the EU H2020 Gov4Nano project, we refined the EU H2020 caLIBRAte phase-gate nano-risk innovation governance framework, its guidance and expanded the list of supporting risk governance tools. Stakeholder wishes were mapped from previous projects and consultations made within Gov4Nano and across the two other EU H2020 NMBP-13 governance projects (NANORIGO and RiskGone) and considered in the refinement. The revised framework considers three pre-defined phase-gate models for minor (fast-track/low risk), intermediate (medium risk) and novel (high-risk) developments. The guidance was further elaborated to direct users though sustainability and safety-by-design considerations and risk mitigation actions. ISO21505 was used as the backbone for the risk governance framework. The approach allows design of the specific nano-risk governance project and information requirements for decision-making. The list of recommended nano-risk governance tools was expanded and selected considering their reliability and performance. An important step in this process was an evaluation of tools made under the umbrella of the OECD (ENV/CBC/MONO(2021)23; ENV/CBC/MONO(2021)27/REV; ENV/CBC/MONO(2021)28; ENV/CBC/MONO(2021)29/REV) and development of a new tool assessment framework called TRAAC (Transparency, Reliability, Accessibility, Applicability and Reliability). Limitations in application domains remains an issue for future developments. The approach and tools are made accessible via a nano-risk governance portal produced by the three NMBP-13 projects (http://nanoriskgov.eu/). Funding: European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreement 814401.

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., Journal of Exposure Science & Environmental Epidemiology, 32 (4), ISSN:1559-064X, ISSN:1559-0631

Background The EU Horizon2020 “safe-by-design for Nano” (SBD4Nano) project aims to develop a tool to assist users in the safe-by-design process and decisions to reduce risk as a result from working with- or using newly developed products containing manufactured nanomaterials (MNs). Therefore, TNO set out to develop an easy-to-use quantitative exposure assessment tool that helps users with different levels of expertise to reduce the exposure from MNs following an integrated Tiered safe-by-design approach. Method Based on previous projects, literature, expert knowledge, a Tiered set of model determinants and corresponding calculations were integrated into a conceptual model. Also, an exposure database based on the EU GRACIOUS template was created containing a large set of exposure measurements collected from diverse literature studies. Machine learning was applied to these exposure measurements to validate and refine the model. Lastly, a safe-by-design module was added to assist users modify their material or process design to reduce exposure. Results An online tool is realized that will be freely available on https://diamonds.tno.nl/#neq. The NEQ offers a Tiered approach by smartly adapting the questions based on the depth of information the user can provide allowing anywhere between a Tier-1 and a Tier-2 approach. After answering questions, the user is presented an exposure estimate including uncertainty of the current design. The user is guided to enter a new design that reduces the exposure and/or its uncertainty.

Paint formulations are complex mixtures of both dissolved and particulate components, both organic and inorganic. Amorphous silica nanoparticles are included to make the paint layer dirt-repellent. Over entire life cycle of the paints containing such silica nanoparticles, however, their complex multicomponent composition may raise several concerns as to their hazard when exposed to humans and environment, notably due to the potential release of the incorporated nano-objects. To mitigate such concerns, several Safe-by-Design target specifications can be performed to provide revised/modified paint formulations with reduced potential risk. Within EU H2020 funded project, HARMLESS (grant agreement 953183), a specific industrial case study focuses on worker exposure measurement at the industrial production site of silane modified silica nanoparticles and consumer exposure measurement during sanding of the painted surfaces containing such silica nanoparticles. First results indicate that the tested paint samples (with and without silica nanoparticles) have strong tendencies to generate airborne nano-objects during their sanding. However, the fraction of silica in the overall chemical composition of the airborne nano-objects is currently being investigated. A fraction of the dust generated during the paint sanding is being analysed for its hazard via advanced in vitro approaches combined with a battery of toxicological endpoint analyses. Based on the results, if the exposure concentration of silica nanoparticles is found to be exceeding its nano reference value (i.e. 40,000 cm-3 TWA) and exhibits deleterious biological impact, the size and surface of silica nanoparticles will be modulated accordingly by keeping an optimum balance between their functionality and risk

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.

This work presents a blueprint or set of guidelines for the planning and development of sustainable national centers dealing with the safety of nanomaterials and nanotechnologies toward public health and environment. The blueprint was developed following a methodological approach of EU-wide online survey and workshop with several stakeholders. The purpose was to identify the key elements and challenges in the development and sustainability of a national nanosafety center. The responses were received from representatives of 16 national nanosafety centers across Europe and 44 people from 18 EU member states who represented the stakeholder groups of researchers, academics, industry, regulators, civil society, and consultants. By providing an overview of the organizational design of existing national nanosafety centers across EU and converging demands in the field of nanosafety, the blueprint principally benefits those EU member states who do not have a national nanosafety center, but intend to develop an entity to manage the human health, environmental, ethical, and social concerns/risks toward the growing nationwide activities on engineered nanomaterials, e.g., their production, use or disposal, at national level.

Measured data are generally preferred to modelled estimates of exposure. Grouping and read-across is already widely used and accepted approach in toxicology, but an appropriate approach and guidance on how to use existing exposure measurement data on one substance and work situation for another substance and/or work situation is currently not available. This study presents a framework for an extensive read-across of existing worker inhalable exposure measurement data. This framework enables the calculation of read-across factors based on another substance and/or work situation by first evaluating the quality of the existing measurement data and then mapping its similarity or difference with another substance and/or work situation. The system of read-across factors was largely based on the determinants in ECETOC TRA and ART exposure models. The applicability of the framework and its proof of principle were demonstrated by using five case studies. In these case studies, either the 75th percentiles of measured exposure data was observed to lie within the estimated 90% confidence intervals from the read-across approach or at least with the increase in the geometric mean of measured exposure, geometric mean of estimated exposure also increased. Testing and re-evaluation of the present framework by experts in exposure assessment and statistics is recommended to develop it further into a tool that can be widely used in exposure assessment and regulatory practices. © The Author(s) 2020. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

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®.

There has been an unprecedented use of advanced materials, particularly manufactured nanomaterials, in industrial applications and consumer products across several sectors 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 the 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 the majority of such tools and methods by stakeholders is limited. Issues of user-friendliness, trust, implementation training, regulatory or authority compliance needs, regulatory acceptance and unsuitability to 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. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework.

This article describes the development of a mechanistic model for underpinning the dermal Advanced REACH Tool (dART), an extension of the existing ART model and its software platform. It was developed for hand exposure to low volatile liquids (vapour pressure ≤ 10 Pa at 20°C) including solids-in-liquid products. The model is based on an existing conceptual dermal source-receptor model that has been integrated into the ART framework. A structured taxonomy of workplace activities referred to as activity classes are adopted from ART. Three key processes involved in mass transport associated with dermal exposure are applied, i.e. deposition, direct emission and contact, and transfer. For deposition, the model adopts all the relevant modifying factors (MFs) applied in ART. In terms of direct emission and contact (e.g. splashes) and transfer (e.g. hand-surface contacts), the model defines independent principal MFs, i.e. substance-related factors, activity-related factors, localized- and dispersion control and exposed surface area of the hands. To address event-based exposures as much as possible, the model includes crucial events during an activity (e.g. hand immersions) and translates objective information on tools and equipment (manual or automated) to probable events (e.g. splashes) and worker behaviours (e.g. surface contacts). Based on an extensive review of peer-reviewed literature and unpublished field studies, multipliers were assigned to each determinant and provide an approximated (dimensionless) numerical value. In the absence of (sufficient) evidence, multipliers were assigned to determinants based on assumptions made during discussions by experts in the consortium. A worked example is presented to illustrate the calculation of hand exposure for a specific scenario. The dART model is not yet implemented in the ART software platform, and a robust validation of the model is necessary to determine its predictive ability. With advancing knowledge on dermal exposure and its determinants, this model will require periodic updates and refinements, in addition to further expansion of the applicability domain of the model. © The Author(s) 2019. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

Introduction Oil and gas workers have been shown to be at increased risk of chronic diseases including cancer, asthma, chronic obstructive pulmonary disease, and hearing loss, among others. Technological advances may be used to assess the external (e.g. personal sensors, smartphone apps and online platforms, exposure models) and internal exposome (e.g. physiologically based kinetic modeling (PBK), biomonitoring, omics), offering numerous possibilities for chronic disease prevention strategies and risk management measures. The objective of this study was to review the literature on these technologies, by focusing on: (i) evaluating their applicability for exposome research in the oil and gas industry, and (ii) identifying key challenges that may hamper the successful application of such technologies in the oil and gas industry. Method A scoping review was conducted by identifying peer-reviewed literature with searches in MEDLINE/PubMed and SciVerse Scopus. Two assessors trained on the search strategy screened retrieved articles on title and abstract. The inclusion criteria used for this review were: application of the aforementioned technologies at a workplace in the oil and gas industry or, application of these technologies for an exposure relevant to the oil and gas industry but in another occupational sector, English language and publication period 2005—end of 2019. Results In total, 72 articles were included in this scoping review with most articles focused on omics and bioinformatics (N = 22), followed by biomonitoring and biomarkers (N = 20), external exposure modeling (N = 11), PBK modeling (N = 10), and personal sensors (N = 9). Several studies were identified in the oil and gas industry on the application of PBK models and biomarkers, mainly focusing on workers exposed to benzene. The application of personal sensors, new types of exposure models, and omics technology are still in their infancy with respect to the oil and gas industry. Nevertheless, applications of these technologies in other occupational sectors showed the potential for application in this sector. Discussion and conclusion New exposome technologies offer great promise for personal monitoring of workers in the oil and gas industry, but more applied research is needed in collaboration with the industry. Current challenges hindering a successful application of such technologies include (i) the technological readiness of sensors, (ii) the availability of data, (iii) the absence of standardized and validated methods, and (iv) the need for new study designs to study the development of disease during working life.

Driven by the concept of the ‘four generations of nanomaterials’, the current state of the knowledge on risk assessment of future generation is explored for active nanomaterials. Through case studies, we identify challenges and evaluate the preparedness of characterization methods, available risk assessment modeling tools, and analytical instrumentation for such future generation active nanomaterials with dynamic hybrid structures of biotic–abiotic and organic–inorganic combinations. Currently available risk assessment tools and analytical instrumentation were found to be lacking the risk preparedness and characterization readiness for active nanomaterials, respectively. Potential future developments in risk assessment modeling tools and analytical techniques can be based upon this work which shall ensure long-term safety of the next generation of nanomaterials.

The challenge in ensuring the safety of manufactured nanomaterials and products stems from the lack of knowledge among industries about the potential environment and health risks of nanotechnology based innovations and the legislations that apply to them. A lack of information and preparedness for the regulatory safety assessment of innovative nanomaterials and products often lead to their delay in market launch or complete abandoning. Safe Innovation Approach (SIA) is a proactive system that aims to minimize the gap between the pace of innovation and the pace of developing nano-specific risk governance. The use of SIA framework in product innovation value chain can ensure sustainable innovative products and rapid market launch for which relevant regulatory framework is in place through a proactive collaboration of all concerned stakeholders. Previous efforts within several European projects and other national collaborations have helped to continue developing a framework for SIA, operationalizing the required infrastructure for its implementation, and developing novel innovation and governance processes for industry and regulators respectively to practice it. In line with these developments, the present work provides a perspective of a risk-based roadmap to be integrated in the current state of the SIA framework. Recommendations to further improve certain aspects of SIA innovation process are provided in this context, and a risk-aware integrated roadmap is presented on the basis of these recommendations to assist the industry to adopt SIA as a regular industrial practice. This can sustainably improve the margin of industrial profit from manufacturing and processing of nanomaterials and products with compliant environmental and human health safety features throughout their life cycle.

The current work describes the interaction with various stakeholder groups to establish consensus on stage-gate specific criteria that human risk assessment (HRA) models for manufactured nanomaterials (MN) need to comply with. During the decisive steps in the innovation process, which can be described in a simplified way as stage-gates, it is decided that an innovation makes it either to launch, or is cancelled during one of these stages. However, at present, it is unknown which current HRA models for MN, can assist in this decision making process and to which extent refinements of these models are needed. To accomplish these goals, several steps were performed: (1) the development of criteria for risk assessment along stage-gates; (2) the active involvement of stakeholders and possible end-users to assign values to these criteria; (3) the inventory, selection and assessment of HRA models according to the developed criteria; (4) the matching of the HRA models to the criteria, assessed by the stakeholders, in order to propose a ranking of existing models and (5) exploration of the model mismatches with stage-gate specific criteria and discussion of current model limitations. The assessment led to a ranking of the models for each of the stage-gates. Two HRA models appeared to be predominantly applicable for all stage-gates, namely the NanoSafer CB and the GUIDEnano tool, where NanoSafer CB scored highest for stage 2 and 3 (scoping and business case) and GUIDEnano tool for stage 4–7 (R&D, testing and validation, launch and monitoring). NanoSafer CB only covers occupational human health. LICARA nanoSCAN scored high for the earlier stages (stage 2, 3 and 4) and scored less for the later stages. RiskofDerm was listed for all stages except stage 3 and 7. ECETOC TRA was represented in stages 3–7, and Stoffenmanager (nano), EGRET2 and ART were applicable for one or two stages. Based on these results, it was possible to prioritize Nanosafer CB, GUIDEnano, RiskofDerm, LICARA nanoSCAN and Stoffenmanager Nano. Of these five models, limitations consisted of e.g. expertise required to use the model, interpretation of the data, quality assessment of the input parameters, consideration of different endpoints and populations (such as children, workers, consumers). Practically, this work provides a prioritization for end users of useful models, among the plethora of different models available, towards HRA of MN. Further, it identifies suggestions for future model improvements, enabling the ultimate practical application in the decision making process during the development of MN or MN containing products.

This review describes an evaluation of the effectiveness of Risk Management Measures (RMM) for nanomaterials in the workplace. Our aim was to review the effectiveness of workplace RMM for nanomaterials and to determine whether established effectiveness values of conventional chemical substances applied for modelling purposes should be adopted or revised based on available evidence. A literature review was conducted to collate nano-specific data on workplace RMM. Besides the quantitative efficacy values, the library was populated with important covariables such as the study design, measurement type, size of particles or agglomerates/aggregates, and metrics applied. In total 770 records were retrieved from 41 studies for three general types of RMM (engineering controls, respiratory equipment and skin protective equipment: gloves and clothing). Records were found for various sub-categories of the different types of RMM although the number of records for each was generally limited. Significant variation in efficacy values was observed within RMM categories while also considering the respective covariables. Based on a comparative evaluation with efficacy values applied for conventional substances, adapted efficacy values are proposed for various RMM sub-categories (e.g. containment, fume cupboards, FFP2 respirators). It is concluded that RMM efficacy data for nanomaterials are limited and often inconclusive to propose effectiveness values. This review also shed some light on the current knowledge gaps for nanomaterials related to RMM effectiveness (e.g. ventilated walk-in enclosures and clean rooms) and the challenges foreseen to derive reliable RMM efficacy values from aggregated data in the future.

Inhalation exposure to low toxicity and biodurable particles has shown to induce polymorphonuclear neutrophilia (PMN) in the lungs, which is a strong indicator for lung inflammation. Recently, Schmid and Stoeger (2016; http://dx.doi.org/10.1016/j.jaerosci.2015.12.006) reviewed mice and rat intratracheal instillation studies and assessed the relation between particles dry powder BET surface area dose and PMN influx for granular biodurable particles (GBPs) and transition metal oxides. In this study, we measured workers alveolar lung deposited surface area (LDSA) concentrations (μm 2 cm − 3 ) during injection molding of polypropylene (PP) car bumpers and production of tungsten-carbide-cobalt (WCCo) fine grade powder using diffusion chargers. First order risk assessment was performed by comparing the doses calculated from measured LDSA concentrations during an 8-h work day with the NOEL 1/100 , the one hundredth of no observed effect level, assigned for GBPs (0.11 cm 2 g − 1 ) and transition metal oxide particles (9 × 10 − 3 cm 2 g − 1 ). During the injection molding of PP car bumpers, LDSA concentrations varied from 23 to 39.8 μm 2 cm − 3 . During 8-h exposure PP, particle doses were at a maximum of 1.4 × 10 − 3 cm 2 g − 1 , which was a factor 100 lower compared to the NOEL 1/100 assigned for GBPs. In the WCCo fine powder production plant, the LDSA concentrations were below 18.7 μm 2 cm − 3 , which corresponds to the 8-h dose of 2.7 × 10 − 3 cm 2 g − 1 . This is 3 times lower than the NOEL 1/100 assigned for transition metal oxide particles. The LDSA concentrations were generally low compared to urban background levels of 44.2 μm 2 cm − 3 in European cities.

This commentary explores the use of high-resolution data from new, miniature sensors to enrich models that predict exposures to chemical substances in the workplace. To optimally apply these sensors, one can expect an increased need for new models that will facilitate the interpretation and extrapolation of the acquired time-resolved data. We identified three key modelling approaches in the context of sensor data, namely (i) enrichment of existing time-integrated exposure models, (ii) (new) high-resolution (in time and space) empirical models, and (iii) new ‘occupational dispersion’ models. Each approach was evaluated in terms of their application in research, practice, and for policy purposes. It is expected that substance-specific sensor data will have the potential to transform workplace modelling by re-calibrating, refining, and validating existing (time-integrated) models. An increased shift towards ‘sensor-driven’ models is expected. It will allow for high-resolution modelling in time and space to identify peak exposures and will be beneficial for more individualized exposure assessment and real-time risk management. New ‘occupational dispersion models’ such as interpolation, computational fluid dynamic models, and assimilation techniques, together with sensor data, will be specifically useful. These techniques can be applied to develop site-specific concentration maps which calculate personal exposures and mitigate worker exposure through early warning systems, source finding and improved control design and control strategies. Critical development and investment needs for sensor data linked to (new) model development were identified such as (i) the generation of more sensor data with reliable sensor technologies (achieved by improved specificity, sensitivity, and accuracy of sensors), (ii) investing in statistical and new model developments, (iii) ensuring that we comply with privacy and security issues of concern, and (iv) acceptance by relevant target groups (such as employers and employees) and stimulation of these new technologies by policymakers and technology developers.

For many work situations only insufficient exposure data are available to perform proper risk assessment. Because measuring worker exposure can be time consuming and resource intense, the availability of reliable exposure models is important when performing risk assessments. However, the development and improvement of exposure models are hampered by scarcity of sound exposure data as well as by lack of information on relevant exposure factors and conditions of exposure. This paper describes a study where inhalation and dermal exposure data were collected under defined conditions. Exposure scenarios examined included tasks that have not been investigated in previous validation studies. The results of these measurements were compared with ECETOC TRA model version 3.1 predictions. In this study, five exposure scenarios were selected, namely ‘use in a closed batch process’ (PROC 4), ‘mixing or blending in a partly open batch process’ (PROC 5), ‘rolling’ (PROC 10), ‘immersion’ (PROC 13), and ‘stirring’ (PROC 19). These PROCs stem from the descriptors that Registration, Evaluation and Authorization of Chemicals has established to depict the identified uses of chemical substances. These exposure scenarios were selected mainly because little or no data are available for these situations, or ECETOC TRA is likely to underestimate exposure for these situations. Experiments were performed by volunteers for the selected exposure scenarios, in which tasks were performed aiming to represent real workplace situations. In total 70 experiments were performed, during which 70 dermal exposure measurements (5 volunteers × 2 repeats × 7 scenarios) and 32 inhalation exposure measurements (4 volunteers × 2 repeats × 4 scenarios) were collected. Two formulations were used, namely pure Tinopal SWN powder (solid product, a fluorescent tracer) and 0.5% Tinopal SWN dissolved in 1,2-dichloroethane (1,2-DCE). DCE is considered a moderate volatile liquid. For exposure scenarios using the liquid formulation, both inhalation and dermal measurements were performed, while for exposure scenarios using the pure powder only dermal exposure measurements were performed. In addition, photographs were taken under ultraviolet light to qualitatively assess exposure patterns on hands and body. Volunteers repeatedly performed a selection of tasks under standardized conditions in a test chamber for each exposure scenario. Results show that ECETOC TRA overestimated dermal hand exposure for all PROCs included in the study, and was considered to be conservative. Additionally, ECETOC TRA overestimated inhalation exposure for closed and partially closed processes, but underestimated inhalation exposure for rolling and handling of immersed objects. Qualitative assessment of the hands and body showed mainly the hands were exposed for tasks involving closed and partially closed processes and when handling of immersed objects. Exposure to other body segments were also observed for rolling and stirring. In conclusion, this study gave insights into dermal and inhalation exposure levels during selected task scenarios, and showed that ECETOC TRA is conservative when dermal exposure is estimated. Inhalation exposure estimates for PROCs 10 and 13 tasks with the moderate volatility liquid were underestimated in this study. It may be therefore necessary to re-evaluate base model predictions for these scenarios when medium fugacity liquids are involved.

Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety. Governmental agencies regulating safety have announced interest toward acceptance of safety data generated under the collective term New Approach Methodologies (NAMs), as such technologies/approaches offer marked potential to progress the integration of safety testing measures during innovation from idea to product launch of nanomaterials. Divided in overall eight main categories, searchable databases for grouping and read across purposes, exposure assessment and modeling, in silico modeling of physicochemical structure and hazard data, in vitro high-throughput and high-content screening assays, dose-response assessments and modeling, analyses of biological processes and toxicity pathways, kinetics and dose extrapolation, consideration of relevant exposure levels and biomarker endpoints typify such useful NAMs. Their application generally agrees with articulated stakeholder needs for improvement of safety testing procedures. They further fit for inclusion and add value in nanomaterials risk assessment tools. Overall 37 of 50 evaluated NAMs and tiered workflows applying NAMs are recommended for considering safer-by-design innovation, including guidance to the selection of specific NAMs in the eight categories. An innovation funnel enriched with safety methods is ultimately proposed under the central aim of promoting rigorous nanomaterials innovation.

A particle exposure experiment inside a large climate-controlled chamber was conducted. Data on spatial and temporal distribution of nanoscale and fine aerosols in the range of mobility diameters 8 - 600 nm were collected with high resolution, for sodium chloride, fluorescein sodium and silica particles. Exposure scenarios studied, included constant and intermittent source emissions, different aggregation conditions, high (10 h-1 ) and low (3.5 h-1 ) air exchange rates (AERs) corresponding to chamber Reynolds number respectively equal to 1.105 and 3.104 . Results are presented and analysed to highlight the main determinants of exposure and to determine if the assumptions underlying two-box models hold under various scenarios. The main determinants of exposure found were the source generation rate and the ventilation rate. The effect of particles nature was indiscernible and the decrease of airborne total number concentrations attributable to surface deposition was estimated lower than 2% when the source was active. A near-field/far-field structure of aerosol concentration was always observed for the AER=10 h-1 but for AER=3.5 h-1 a single field structure was found. The particle size distribution was always homogeneous in space but a general shift of particles diameter (-8% to +16%) was observed between scenarios in correlation with the AER and with the source position, presumably largely attributable to aggregation. This article is protected by copyright. All rights reserved.

The widespread use of engineered nanomaterials (ENMs) in consumer products and the overwhelming uncertainties in their ecological and human health risks have raised concerns regarding their safety among industries and regulators. There has been an ongoing debate over the past few decades on ways to overcome the challenges in assessing and mitigating nano-related risks, which has reached a phase of general consensus that nanotechnology innovation should be accompanied by the application of the precautionary principle and best practice risk management, even if the risk assessment uncertainties are large. We propose a quantitative methodology for selecting the optimal risk control strategy based on information about human health and ecological risks, efficacy of risk mitigation measures, cost and other contextual factors. The risk control (RC) methodology was developed in the European FP7 research project SUN and successfully demonstrated in two case studies involving real industrial nano-enabled products (NEPs): nano-scale copper oxide (CuO) and basic copper carbonate (Cu2(OH)2CO3) used as antimicrobial and antifungal coatings and impregnations for the preservation of treated wood, and two nanoscale pigments used for colouring plastic automotive parts (i.e. red organic pigment and carbon black). The application of RC for human health risks showed that although nano-related risks could easily be controlled in automotive plastics case study with modifications in production technology or specific type of engineering controls, nano-related risks due to sanding and sawing copper oxide painted wood were non-acceptable in the use lifecycle stage and would need the identification of a more effective risk control strategy. Keywords: Nanomaterials, Risk assessment, Risk management, Life cycle, Nano-copper oxide, Nano-pigments

For safe innovation, knowledge on potential human health impacts is essential. Ideally, these impacts are considered within a larger life-cycle-based context to support sustainable development of new applications and products. A methodological framework that accounts for human health impacts caused by inhalation of engineered nanomaterials (ENMs) in an indoor air environment has been previously developed. The objectives of this study are as follows: (i) evaluate the feasibility of applying the CF framework for NP exposure in the workplace based on currently available data; and (ii) supplement any resulting knowledge gaps with methods and data from the life cycle approach and human risk assessment (LICARA) project to develop a modified case-specific version of the framework that will enable near-term inclusion of NP human health impacts in life cycle assessment (LCA) using a case study involving nanoscale titanium dioxide (nanoTiO2 ). The intent is to enhance typical LCA with elements of regulatory risk assessment, including its more detailed measure of uncertainty. The proof-of-principle demonstration of the framework highlighted the lack of available data for both the workplace emissions and human health effects of ENMs that is needed to calculate generalizable characterization factors using common human health impact assessment practices in LCA. The alternative approach of using intake fractions derived from workplace air concentration measurements and effect factors based on best-available toxicity data supported the current case-by-case approach for assessing the human health life cycle impacts of ENMs. Ultimately, the proposed framework and calculations demonstrate the potential utility of integrating elements of risk assessment with LCA for ENMs once the data are available.

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.

from the 32nd Triennial Congress of the International Commission on Occupational Health (ICOH), Dublin, Ireland, 29th April to 4th May 2018. In the EU, 1 00 000 to 1 50 000 people are diagnosed with cancer caused by exposure to carcinogenic substances during their work every year. This exposure causes a lot of personal injury and considerable social costs, also in comparison with other causes of death. Exposure to carcinogens is a major risk factor; good reason to address this by prevention at the source. This can be done by substitution of carcinogenic substances or processes, or by design of workplaces and tools in combination with frequent and careful use of dust-free tools and other good practices. The improvement potential is high and there are currently good initiatives in various sectors that create a healthy work environment. The currently available technological solutions offer great potential for improvement to reduce exposure. By better implementation, enforcement and information a lot of health profit will be gained. In order to work well, it is also important that workers are aware of the risks of carcinogens in their daily work. It is important to educate workers about the risks and the available solutions. For many of the control measures and good practices, the conditions are favourable, because there is a legal necessity: meeting the occupational exposure limit, contributing to good employment, funds are available and purchase costs are limited and cost reduction is possible on material costs and reduced cleaning costs. There are also a number of good initiatives and thus it seems possible to achieve a big effect. This presentation will give insight into various good practices and innovative technical solutions and methods in a variety of industries, which are currently available. When widely applied these good practices can heavily reduce work-related cancer in those sectors.

Fume hoods are one of the most common types of equipment applied to reduce the potential of particle exposure in laboratory environments. A number of previous studies have shown particle release during work with nanomaterials under fume hoods. Here, we assessed laboratory workers’ inhalation exposure during synthesis and handling of CuO, TiO2 and ZnO in a fume hood. In addition, we tested the capacity of a fume hood to prevent particle release to laboratory air during simulated spillage of different powders (silica fume, zirconia TZ-3Y and TiO2). Airborne particle concentrations were measured in near field, far field, and in the breathing zone of the worker. Handling CuO nanoparticles increased the concentration of small particles (

Nanoscale TiO

Nanoscale TiO2 (nTiO2) is manufactured in high volumes and is of potential concern in occupational health. Here, we measured workers exposure levels while ceramic honeycombs were dip coated with liquid photoactive nanoparticle suspension and dried with an air blade. The measured nTiO2 concentration levels were used to assess process specific emission rates using a convolution theorem and to calculate inhalation dose rates of deposited nTiO2 particles. Dip coating did not result in detectable release of particles but air blade drying released fine-sized TiO2 and nTiO2 particles. nTiO2 was found in pure nTiO2 agglomerates and as individual particles deposited onto background particles. Total particle emission rates were 420 × 109 min−1, 1.33 × 109 μm2 min−1, and 3.5 mg min−1 respirable mass. During a continued repeated process, the average exposure level was 2.5 × 104 cm−3, 30.3 μm2 cm−3,−3 for particulate matter. The TiO2 average exposure level was 4.2 μg m−3, which is well below the maximum recommended exposure limit of 300 μg m−3 for nTiO2 proposed by the US National Institute for Occupational Safety and Health. During an 8-hour exposure, the observed concentrations would result in a lung deposited surface area of 4.3 × 10−3 cm2 g−1 of lung tissue and 13 μg of TiO2 to the trachea-bronchi, and alveolar regions. The dose levels were well below the one hundredth of the no observed effect level (NOEL1/100) of 0.11 cm2 g−1 for granular biodurable particles and a daily no significant risk dose level of 44 μg day−1. These emission rates can be used in a mass flow model to predict the impact of process emissions on personal and environmental exposure levels.

Real-time exposure measurements to nano-sized particles may result in large amounts of time series data on particle size and total number concentration. Analysis of the particle size distribution have thus far been limited to either graphical analysis of the distribution over time or an evaluation of the mode over time. For large time series data, graphical analysis of distributions is complicated and an assessment of the mode ignores the important aspect of the variance in particle size. A statistical method of analysis is proposed that overcomes those problems, based on a multilevel modeling approach and assuming a lognormal model for the particle size distribution. Two empirical examples illustrate the advantages of the proposed model, showing that useful summaries and inferences can be obtained, even for large data sets. The model thus provides a tool for practitioners to deal with large amounts of particle size distribution data obtained from real-time nano measurement devices.

Exposure assessment for nano-objects, and their aggregates and agglomerates (NOAA), has evolved from explorative research toward more comprehensive exposure assessment, providing data to further develop currently used conservative control banding (CB) tools for risk assessment. This study aims to provide an overview of current knowledge on emission potential of NOAA across the occupational life cycle stages by a systematic review and subsequently use the results in a data analysis. Relevant parameters that influence emission were collected from peer-reviewed literature with a focus on the four source domains (SD) in the source-receptor conceptual framework for NOAA. To make the reviewed exposure data comparable, we applied an approach to normalize for workplace circumstances and measurement location, resulting in comparable "surrogate" emission levels. Finally, descriptive statistics were performed. During the synthesis of nanoparticles (SD1), mechanical reduction and gas phase synthesis resulted in the highest emission compared to wet chemistry and chemical vapor condensation. For the handling and transfer of bulk manufactured nanomaterial powders (SD2) the emission could be differentiated for five activity classes: (1) harvesting; (2) dumping; (3); mixing; (4) cleaning of a reactor; and (5) transferring. Additionally, SD2 was subdivided by the handled amount with cleaning further subdivided by energy level. Harvesting and dumping resulted in the highest emissions. Regarding processes with liquids (SD3b), it was possible to distinguish emissions for spraying (propellant gas, (high) pressure and pump), sonication and brushing/rolling. The highest emissions observed in SD3b were for propellant gas spraying and pressure spraying. The highest emissions for the handling of nano-articles (SD4) were found to nano-sized particles (including NOAA) for grinding. This study provides a valuable overview of emission assessments performed in the workplace during the occupational handling of NOAA. Analyses were made per source domain to derive emission levels which can be used for models to quantitatively predict the exposure.

The release of pesticides from conventional spray products has been investigated in depth, and suitable analytical techniques detecting the mass of the released substances are available. In contrast, nanoparticle-containing sprays are less studied, although they are perceived as critical for consumers because inhalation exposure can occur to potentially toxic nanoparticles. A few recent studies presented analytical concepts for exposure experiments and generated data for exposure assessment. This study attempts to review and compare the current approaches to characterize nanosprays and to identify challenges for future research. Furthermore, experimental setups used for exposure assessment from conventional sprays are reviewed and compared to setups used for nanoparticle-containing sprays. National and international norms dealing with nanoparticle characterization, spray characterization and exposure are inspected with regard to their usefulness for standardizing exposure assessment. Different approaches in the field of exposure modeling are reviewed and compared. The conclusion is that due to largely varying experimental setups to date exposure values for nanosprays are difficult to compare. All studies are only conducted with a limited set of sprays, and no systematic evaluation of the study conditions is available. A suitable set of experimental setups as well as minimum reporting requirements should be agreed upon to enable the systematic evaluation of consumer sprays in the future. Indispensable features of such experimental setups are developed in this review. © 2014 American Chemical Society.

The ECETOC TRA model (presently version 3.1) is often used to estimate worker inhalation and dermal exposure in regulatory risk assessment. The dermal model in ECETOC TRA has not yet been validated by comparison with independent measured exposure levels. This was the goal of the present study. Measured exposure levels and relevant contextual information were gathered via literature search, websites of relevant occupational health institutes and direct requests for data to industry. Exposure data were clustered in so-called exposure cases, which are sets of data from one data source that are expected to have the same values for input parameters in the ECETOC TRA dermal exposure model. For each exposure case, the 75th percentile of measured values was calculated, because the model intends to estimate these values. The input values for the parameters in ECETOC TRA were assigned by an expert elicitation and consensus building process, based on descriptions of relevant contextual information. From more than 35 data sources, 106 useful exposure cases were derived, that were used for direct comparison with the model estimates. The exposure cases covered a large part of the ECETOC TRA dermal exposure model. The model explained 37% of the variance in the 75th percentiles of measured values. In around 80% of the exposure cases, the model estimate was higher than the 75th percentile of measured values. In the remaining exposure cases, the model estimate may not be sufficiently conservative. The model was shown to have a clear bias towards (severe) overestimation of dermal exposure at low measured exposure values, while all cases of apparent underestimation by the ECETOC TRA dermal exposure model occurred at high measured exposure values. This can be partly explained by a built-in bias in the effect of concentration of substance in product used, duration of exposure and the use of protective gloves in the model. The effect of protective gloves was calculated to be on average a factor of 34 in this data set, while factors of five to ten were used in the model estimations. There was also an effect of the sampling method in the measured data on the exposure levels. Exposure cases where sampling was done via an interception method, such as gloves, on average showed a factor of six higher 75th percentiles of measured values than exposure cases where sampling was done via a removal method, such as hand washing. This may partly be responsible for the apparent underestimation of dermal exposure by the model at high exposure values. However, there also appeared to be a relation between expected exposure level (as indicated by the model estimate) and the choice of sampling method. In this study, solid substances used in liquid products were treated as liquids with negligible volatility. The results indicate that the ECETOC TRA dermal exposure model performs equally well for these substances as for liquids. There were suggestions of a difference in performance of the model between solids and liquids. For several parts of the ECETOC TRA dermal model, no or hardly any measured dermal exposure data were available. Therefore, gathering of more dermal exposure levels is recommended, specifically for situations not yet sufficiently covered in the present data set. © The Author 2017. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

While the risk management of engineered nanomaterials (ENMs) receives significant attention, there is still a limited understanding of how to select optimal risk management measures (RMMs) for controlling and mitigating the risks associated with exposure to ENMs. Clearly, there exists a need to expand current risk management practices to ensure safe production, handling and use of ENMs. Moreover, the performance of the existing RMMs should be re-evaluated for ENMs since control options that are proven to be effective for preventing or limiting risks associated with traditional particles might give unsatisfactory results in the case of nano-scale particles. This paper has brought together the evidence on the adequacy of traditional controls to minimize potential health and environmental risks resulting from exposure to ENMs. The aim here is to advance our understanding of the risk management approaches relevant for ENMs, and ultimately to support the selection of the most suitable RMMs when handling ENMs. To that end, evaluative evidence collected from the review of relevant literature and survey of nanotechnology institutions are combined and summarised to understand the level of protection offered by each control measure, as well as the relative costs of their implementation. The findings suggest that most relevant risk control options are based on isolating people from hazard through engineering measures (e.g. ventilation and chemical fume hoods) or personal protective equipment (PPE), rather than eliminating hazard at source (e.g. substitution). Although control measures related to the modification of ENMs have high efficiency in the occupational risk control hierarchy, they are not widely employed since there is currently a high degree of uncertainty regarding the impact of manipulating nano-characteristics on the performance of final product. Lastly, despite its low cost, PPE is the least effective category in the occupational risk control hierarchy and should not be used on its own when significant risk reduction is required. Clearly, further quantitative data is needed to fully assess the feasibility and cost-effectiveness of risk control options to prevent risks from exposure to ENMs. When there is little information on the efficiency of control measures specific to ENMs, the default efficiencies can be used for initial assessment purposes although it should not be considered exhaustive. © The Royal Society of Chemistry 2016.

Increasing production and applications of manufactured nano objects (MNOs) have become a source for human exposure and therefore raise concerns and questions about the possible health effects. In this study, the potential release of nano objects, their agglomerates, and aggregates (NOAA) as a result of sanding of hardwood treated with MNOs-containing coating was examined. Two types of MNO-containing coating were compared with untreated hardwood that allowed the evaluation of the influence of the chemical composition on the release of particles. Furthermore, the rotation speed of the sander and the grit size of the sanding paper were varied in order to assess their influence on the release of particles. Measurements were conducted in a gas-Tight chamber with a volume of 19.5 m3 in which ventilation was minimized during experiments. Particle size distributions were assessed by scanning mobility particle sizer, aerodynamic particle sizer, and electrical low pressure impactor. Furthermore, aerosol number concentrations (Nanotracer), active surface area (LQ1), and fractionated mass (Cascade Impactor) were measured before, during, and after sanding. Scanning electron microscope/energy dispersive X-ray (SEM/EDX) analysis was performed to adequately characterize the morphology, size, and chemical composition of released particles. SEM/EDX analysis indicated that sanding surfaces treated with MNO-containing coating did not release the designated MNO as free primary particles. In both coatings, clusters of MNO were perceived embedded in and attached to micro-sized wood and/or coating particles created by sanding the coated surface. Real-Time measurements indicated a lower release of micro-sized particles from sanding of surfaces treated with Coating I than from sanding untreated surfaces or surfaces treated with Coating II. A substantial increase in nanosized and a slight increase in micro-sized particles was perceived as the rotation speed of the sander increased. However, most nanosized particles were most likely emitted by the sanding machine. No effect of the grit size on the release of particles was detected. © 2016 The Author 2016. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

Measurement strategies for exposure to nano-sized particles differ from traditional integrated sampling methods for exposure assessment by the use of real-time instruments. The resulting measurement series is a time series, where typically the sequential measurements are not independent from each other but show a pattern of autocorrelation. This article addresses the statistical difficulties when analyzing real-time measurements for exposure assessment to manufactured nano objects. To account for autocorrelation patterns, Autoregressive Integrated Moving Average (ARIMA) models are proposed. A simulation study shows the pitfalls of using a standard t-test and the application of ARIMA models is illustrated with three real-data examples. Some practical suggestions for the data analysis of real-time exposure measurements conclude this article.

The fast penetration of nanoproducts on the market under conditions of significant uncertainty of their environmental properties and risks to humans creates a need for companies to assess sustainability of their products. Evaluation of the potential benefits and risks to build a coherent story for communication with clients, authorities, consumers, and other stakeholders is getting to be increasingly important, but SMEs often lack the knowledge and expertise to assess risks and communicate them appropriately. This paper introduces LICARA nanoSCAN, a modular web based tool that supports SMEs in assessing benefits and risks associated with new or existing nanoproducts. This tool is unique because it is scanning both the benefits and risks over the nanoproducts life cycle in comparison to a reference product with a similar functionality in order to enable the development of sustainable and competitive nanoproducts. SMEs can use data and expert judgment to answer mainly qualitative and semi-quantitative questions as a part of tool application. Risks to public, workers and consumers are assessed, while the benefits are evaluated for economic, environmental and societal opportunities associated with the product use. The tool provides an easy way to visualize results as well as to identify gaps, missing data and associated uncertainties. The LICARA nanoSCAN has been positively evaluated by several companies and was tested in a number of case studies. The tool helps to develop a consistent and comprehensive argument on the weaknesses and strengths of a nanoproduct that may be valuable for the communication with authorities, clients and among stakeholders in the value chain. LICARA nanoSCAN identifies areas for more detailed assessments, product design improvement or application of risk mitigation measures. Keywords: Risk assessment, Benefit assessment, Nanoproducts, Decision-making tool, Sustainable nanotechnology, Life Cycle Assessment

Life-Cycle Assessment (LCA) is a well-established method to evaluate impacts of chemicals on the environment and human health along the lifespan of products. However, the increasingly produced and applied nanomaterials (defined as one dimension, Journal of Nanoparticle Research, 17, ISSN:1388-0764, ISSN:1572-896X

Nanoparticle (particles with diameter ≤100 nm) exposure is recognized as a potentially harmful size fraction for pulmonary particle exposure. During nanoparticle synthesis, the number concentrations in the process room may exceed 10 × 106 cm−3. During such conditions, it is essential that the occupants in the room wear highly reliable high-performance respirators to prevent inhalation exposure. Here we have studied the in-use program protection factor (PPF) of loose-fitting powered air purifying respirators, while workers were coating components with TiO 2 or Cu x O y nanoparticles under a hood using a liquid flame spray process. The PPF was measured using condensation particle counters, an electrical low pressure impactor, and diffusion chargers. The room particle concentrations varied from 4 × 106 to 40 × 106 cm−3, and the count median aerodynamic diameter ranged from 32 to 180 nm. Concentrations inside the respirator varied from 0.7 to 7.2 cm−3. However, on average, tidal breathing was assumed to increase the respirator concentration by 2.3 cm−3. The derived PPF exceeded 1.1 × 106, which is more than 40 × 103 times the respirator assigned protection factor. We were unable to measure clear differences in the PPF of respirators with old and new filters, among two male and one female user, or assess most penetrating particle size. This study shows that the loose-fitting powered air purifying respirator provides very efficient protection against nanoparticle inhalation exposure if used properly. © 2015, Springer Science+Business Media Dordrecht.

For safe innovation, knowledge on potential human health impacts is essential. Ideally, these impacts are considered within a larger life-cycle-based context to support sustainable development of new applications and products. A methodological framework that accounts for human health impacts caused by inhalation of engineered nanomaterials (ENMs) in an indoor air environment has been previously developed. The objectives of this study are as follows: (i) evaluate the feasibility of applying the CF framework for NP exposure in the workplace based on currently available data; and (ii) supplement any resulting knowledge gaps with methods and data from the life cycle approach and human risk assessment (LICARA) project to develop a modified case-specific version of the framework that will enable near-term inclusion of NP human health impacts in life cycle assessment (LCA) using a case study involving nanoscale titanium dioxide (nanoTiO

The development of nanotechnology has reached a point where it is being widely applied, and numerous nanomaterials and nano-enabled products are handled across a broad range of industrial sectors. Exposure extends beyond occupational settings as products containing nanomaterials are used by different consumer groups. Despite the knowledge on their toxic effects is growing there is still not OEL for most NMS and therefore the precautionary approach is still used where levels are kept as low as possible Therefore there is a need to assess workers and consumers exposure. © Published under licence by IOP Publishing Ltd.

This paper reports a study of the dispersion of manufactured nano-objects (MNOs) through the air, both in time and space, during the use of two commercially available nano-spray products and comparable products without MNOs. The main objective was to identify whether personal exposure can occur at a greater distance than the immediate proximity of the source (>1 m from the source), that is, in the "far field" (bystanders), or at a period after the emission occurred (re-entry). The spray experiments were conducted in an experimental room with well-controlled environmental and ventilation conditions (19.5 m 3). The concentration of MNOs was investigated by measuring real-time size distribution, number, and active surface area concentration. For off-line analysis of the particles in the air, samples for scanning/transmission electron microscopy and elemental analysis were collected. The release of MNOs was measured at ∼30 and 290 cm from the source ("near field" and "far field", respectively). For all four spray products, the maximum number and surface area concentrations in the "near field" exceeded the maximum concentrations reached in the "far field". At 2 min after the emission occurred, the concentration in both the "near field" and "far field" reached a comparable steady-state level above background level. These steady-state concentrations remained elevated above background concentration throughout the entire measurement period (12 min). The results of the real-time measurement devices mainly reflect the liquid aerosols emitted by the spray process itself rather than only the MNO, which hampers the interpretation of the results. However, the combination of the off-line analysis and the results of the real-time devices indicates that after the use of nano-spray products, personal exposure to MNOs can occur not only in the near field, but also at a greater distance than the immediate proximity of the source and at a period after emission occurred. © 2014 Nature America, Inc.

This article describes the structure, functionalities, and content of the Advanced REACH Tool (ART) exposure database (version 1.5). The incorporation of the exposure database into ART allows users who do not have their own measurement data for their exposure scenario, to update the exposure estimates produced by the mechanistic model using analogous measurement series selected from the ART exposure measurement database. Depending on user input for substance category and activity (sub)classes, the system selects exposure measurement series from the exposure database. The comprehensive scenario descriptions and summary statistics assist the user in deciding if the measurement series are indeed fully analogous. After selecting one or more analogous data sets, the data are used by the Bayesian module of the ART system to update the mechanistically modeled exposure estimates. The 1944 exposure measurements currently stored in the ART exposure measurement database cover 9 exposure situations for handling solid objects (n = 65), 42 situations for handling powders, granules, or pelletized material (n = 488), 5 situations for handling low-volatility liquids (n = 88), 35 situations for handling volatile liquids (n = 870), and 26 situations for handling liquids in which powders are dissolved or dispersed (resulting in exposure to mist) (n = 433). These 117 measurement series form a good basis for supporting user exposure estimates. However, by increasing the diversity of exposure situations and the number of measurement series in the database, the usefulness of the ART system will be further improved. Suggestions to stimulate the process of sharing exposure measurement data both to increase the available data in the ART and for other purposes are made.

Stoffenmanager Nano (version 1.0) is a risk-banding tool developed for employers and employees to prioritize health risks occurring as a result of exposure to manufactured nano objects (MNOs) for a broad range of worker scenarios and to assist implementation of control measures to reduce exposure levels. In order to prioritize the health risks, the Stoffenmanager Nano combines the available hazard information of a substance with a qualitative estimate of potential for inhalation exposure. The development of the Stoffenmanager Nano started with a review of the available literature on control banding. Input parameters for the hazard assessment of MNOs were selected based on the availability of these parameters in, for instance, Safety Data Sheets or product information sheets. The conceptual exposure model described by Schneider et al. (2011) was used as the starting point for exposure banding. During the development of the Stoffenmanager Nano tool, the precautionary principle was applied to deal with the uncertainty regarding hazard and exposure assessment of MNOs. Subsequently, the model was converted into an online tool (http://nano.stoffenmanager.nl), tested, and reviewed by a number of companies. In this paper, we describe the Stoffenmanager Nano. This tool offers a practical approach for risk prioritization in exposure situations where quantitative risk assessment is currently not possible. Updates of this first version are anticipated as more data become available in the future.

Objectives: 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. Methods: 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%. Results: 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 225 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 5 0.90, n 5 15 scenarios; machining: rs 5 0.84, n 5 22 scenarios) as for the 90th percentile (handling: rs 5 0.79; machining: rs 5 0.76). Conclusions: 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.

This paper provides an outline of the Advanced REACH Tool (ART) version 1.0 and a discussion of how it could be further developed. ART is a higher tier exposure assessment tool that combines mechanistically modelled inhalation exposure predictions with available exposure data using a Bayesian approach. ART assesses exposure for scenarios across different plants and sites. Estimates are provided for different percentiles of the exposure distribution and confidence intervals around the estimate. It also produces exposure estimates in the absence of data, but uncertainty of the estimates will decrease when results of exposure measurements are included. The tool has been calibrated using a broad range of exposure data and provides estimates for exposure to vapours, mists, and dusts. ART has a robust and stable conceptual basis but will be refined in the future and should therefore be considered an evolving system. High-priority areas for future research are identified in this paper and include the integration of partially analogous measurement series, inclusion of company and site-specific assessments, user decision strategies linked to ART predictions, evaluation of validity and reliability of ART, exploring the possibilities for incorporating the dermal route and integration of ART predictions with tools for modelling internal dose. ART is initially developed in the scope of REACH but is equally useful for exposure assessment in other areas. © The Author 2011.

The Advanced REACH Tool (ART) is an exposure assessment tool that combines mechanistically modelled inhalation exposure estimates with available exposure data using a Bayesian approach. The mechanistic model is based on nine independent principal modifying factors (MF). One of these MF is the substance emission potential, which addresses the intrinsic substance properties as determinants of the emission from a source. This paper describes the current knowledge and evidence on intrinsic characteristics of solids and liquids that determine the potential for their release into workplace air. The principal factor determining the release of aerosols from handling or processing powdered, granular, or pelletized materials is the dustiness of the material, as well as the weight fraction of the substance of interest in the powder and the moisture content. The partial vapour pressure is the main intrinsic factor determining the substance emission potential for emission of vapours. For generation of mist, the substance emission potential is determined by the viscosity of the liquid as well as the weight fraction of the substance of interest in the liquid. Within ART release of vapours is considered for substances with a partial vapour pressure at the process temperature of 10 Pa or more, while mist formation is considered for substances with a vapour pressure =10 Pa. Relative multipliers are assigned for most of the intrinsic factors, with the exception of the weight fraction and the vapour pressure, which is applied as a continuous variable in the estimation of the substance emission potential. Currently, estimation of substance emission potential is not available for fumes, fibres, and gases. The substance emission potential takes account of the latest thinking on emissions of dusts, mists, and vapours and in our view provides a good balance between theory and pragmatism. Expanding the knowledge base on substance emission potential will improve the predictive power of occupational exposure models and thereby the accuracy and precision of the exposure estimates. © The Author 2011.