Evaluation of Decision Rules in a Tiered Assessment of Inhalation Exposure to Nanomaterials.

Tiered or stepwise approaches to assess occupational exposure to nano-objects, and their agglomerates and aggregates have been proposed, which require decision rules (DRs) to move to a next tier, or terminate the assessment. In a desk study the performance of a number of DRs based on the evaluation of results from direct reading instruments was investigated by both statistical simulations and the application of the DRs to real workplace data sets. A statistical model that accounts for autocorrelation patterns in time-series, i.e. autoregressive integrated moving average (ARIMA), was used as 'gold' standard. The simulations showed that none of the proposed DRs covered the entire range of simulated scenarios with respect to the ARIMA model parameters, however, a combined DR showed a slightly better agreement. Application of the DRs to real workplace datasets (n = 117) revealed sensitivity up to 0.72, whereas the lowest observed specificity was 0.95. The selection of the most appropriate DR is very much dependent on the consequences of the decision, i.e. ruling in or ruling out of scenarios for further evaluation. Since a basic assessment may also comprise of other type of measurements and information, an evaluation logic was proposed which embeds the DRs, but furthermore supports decision making in view of a tiered-approach exposure assessment.

Exposure Monitoring Strategies for Applying Low-Cost PM Sensors to Assess Flour Dust in Industrial Bakeries.

Low-cost particulate matter (PM) sensors provide new methods for monitoring occupational exposure to hazardous substances, such as flour dust. These devices have many possible benefits, but much remains unknown about their performance for different exposure monitoring strategies in the workplace. We explored the performance of PM sensors for four different monitoring strategies (time-weighted average and high time resolution, each quantitative and semi-quantitative) for assessing occupational exposure using low-cost PM sensors in a field study in the industrial bakery sector. Measurements were collected using four types of sensor (PATS+, Isensit, Airbeam2, and Munisense) and two reference devices (respirable gravimetric samplers and an established time-resolved device) at two large-scale bakeries, spread over 11 participants and 6 measurement days. Average PM2.5 concentrations of the low-cost sensors were compared with gravimetric respirable concentrations for 8-h shift periods and 1-min PM2.5 concentrations of the low-cost sensors were compared with time-resolved PM2.5 data from the reference device (quantitative monitoring strategy). Low-cost sensors were also ranked in terms of exposure for 8-h shifts and for 15-min periods with a shift (semi-quantitative monitoring strategy). Environmental factors and methodological variables, which can affect sensor performance, were investigated. Semi-quantitative monitoring strategies only showed more accurate results compared with quantitative strategies when these were based on shift-average exposures. The main factors that influenced sensor performance were the type of placement (positioning the devices stationary versus personal) and the company or workstation where measurements were collected. Together, these findings provide an overview of common strengths and drawbacks of low-cost sensors and different ways these can be applied in the workplace. This can be used as a starting point for further investigations and the development of guidance documents and data analysis methods.

Towards health-based nano reference values (HNRVs) for occupational exposure: Recommendations from an expert panel.

Unique physicochemical characteristics of engineered nanomaterials (ENMs) suggest the need for nanomaterial-specific occupational exposure limits (OELs). Setting these limits remains a challenge. Therefore, the aim of this study was to set out a framework to evaluate the feasibility of deriving advisory health-based occupational limit values for groups of ENMs, based on scientific knowledge. We have used an expert panel approach to address three questions: 1) What ENM-categories should be distinguished to derive advisory health-based occupational limit values (or health-based Nano Reference Values, HNRVs) for groups of ENMs? 2) What evidence would be needed to define values for these categories? And 3) How much effort would it take to achieve this? The panel experts distinguished six possible categories of HNRVs: A) WHO-fiber-like high aspect ratio ENMs (HARNs), B) Non-WHO-fiber-like HARNs and other non-spheroidal ENMs, C) readily soluble spheroidal ENMs, D) biopersistent spheroidal ENMs with unknown toxicity, E) biopersistent spheroidal ENMs with substance-specific toxicity and F) biopersistent spheroidal ENMs with relatively low substance-specific toxicity. For category A, the WHO-fiber-like HARNs, agreement was reached on criteria defining this category and the approach of using health-based risk estimates for asbestos to derive the HNRV. For category B, a quite heterogeneous category, more toxicity data are needed to set an HNRV. For category C, readily soluble spheroidal ENMs, using the OEL of their molecular or ionic counterpart would be a good starting point. For the biopersistent ENMs with unknown toxicity, HNRVs cannot be applied as case-by-case testing is required. For the other biopersistent ENMs in category E and F, we make several recommendations that can facilitate the derivation of these HNRVs. The proposed categories and recommendations as outlined by this expert panel can serve as a reference point for derivation of HNRVs when health-based OELs for ENMs are not yet available.

Blueprint for a self-sustained European Centre for service provision in safe and sustainable innovation for nanotechnology.

The coming years are expected to bring rapid changes in the nanotechnology regulatory landscape, with the establishment of a new framework for nano-risk governance, in silico approaches for characterisation and risk assessment of nanomaterials, and novel procedures for the early identification and management of nanomaterial risks. In this context, Safe(r)-by-Design (SbD) emerges as a powerful preventive approach to support the development of safe and sustainable (SSbD) nanotechnology-based products and processes throughout the life cycle. This paper summarises the work undertaken to develop a blueprint for the deployment and operation of a permanent European Centre of collaborating laboratories and research organisations supporting safe innovation in nanotechnologies. The proposed entity, referred to as "the Centre", will establish a 'one-stop shop' for nanosafety-related services and a central contact point for addressing stakeholder questions about nanosafety. Its operation will rely on significant business, legal and market knowledge, as well as other tools developed and acquired through the EU-funded EC4SafeNano project and subsequent ongoing activities. The proposed blueprint adopts a demand-driven service update scheme to allow the necessary vigilance and flexibility to identify opportunities and adjust its activities and services in the rapidly evolving regulatory and nano risk governance landscape. The proposed Centre will play a major role as a conduit to transfer scientific knowledge between the research and commercial laboratories or consultants able to provide high quality nanosafety services, and the end-users of such services (e.g., industry, SMEs, consultancy firms, and regulatory authorities). The Centre will harmonise service provision, and bring novel risk assessment and management approaches, e.g. in silico methodologies, closer to practice, notably through SbD/SSbD, and decisively support safe and sustainable innovation of industrial production in the nanotechnology industry according to the European Chemicals Strategy for Sustainability.

A structured observational method to assess dermal exposure to manufactured nanoparticles DREAM as an initial assessment tool.

Preliminary results of inventories of exposure scenarios for nanomaterials have indicated possible dermal exposure. Within the NANOSH project focused on occupational safety and health aspects of nanotechnology a shortened version of the observational DeRmal Exposure AssessMent (DREAM) method was used as an initial method to assess dermal exposure. A total of 45 tasks (such as bagging, dumping, and cleaning) involving different manufactured nanoparticles (MNPs) such as carbon nanotubes, fumed silica, and cerium oxide, were observed in industrial and research facilities. In 39 tasks potential dermal exposure (that is, exposure of the skin and clothing) was likely to occur. Exposure resulted from different routes, including direct contact with MNPs as well as the deposition or transfer of MNPs. The survey showed it is both feasible and useful to assess the potential dermal exposure using shortened DREAM questionnaires.

Exploring Evaluation Variables for Low-Cost Particulate Matter Monitors to Assess Occupational Exposure.

(1) Background: Small, lightweight, low-cost optical particulate matter (PM) monitors are becoming popular in the field of occupational exposure monitoring, because these devices allow for real-time static measurements to be collected at multiple locations throughout a work site as well as being used as wearables providing personal exposure estimates. Prior to deployment, devices should be evaluated to optimize and quantify measurement accuracy. However, this can turn out to be difficult, as no standardized methods are yet available and different deployments may require different evaluation procedures. To gain insight in the relevance of different variables that may affect the monitor readings, six PM monitors were selected based on current availability and evaluated in the laboratory; (2) Methods: Existing strategies that were judged appropriate for the evaluation of PM monitors were reviewed and seven evaluation variables were selected, namely the type of dust, within- and between-device variations, nature of the power supply, temperature, relative humidity, and exposure pattern (peak and constant). Each variable was tested and analyzed individually and, if found to affect the readings significantly, included in a final correction model specific to each monitor. Finally, the accuracy for each monitor after correction was calculated; (3) Results: The reference materials and exposure patterns were found to be main factors needing correction for most monitors. One PM monitor was found to be sufficiently accurate at concentrations up to 2000 µg/m3 PM2.5, with other monitors appropriate at lower concentrations. The average accuracy increased by up to three-fold compared to when the correction model did not include evaluation variables; (4) Conclusions: Laboratory evaluation and readings correction can greatly increase the accuracy of PM monitors and set boundaries for appropriate use. However, this requires identifying the relevant evaluation variables, which are heavily reliant on how the monitors are used in the workplace. This, together with the lack of current consensus on standardized procedures, shows the need for harmonized PM monitor evaluation methods for occupational exposure monitoring.

Inter-comparison of personal monitors for nanoparticles exposure at workplaces and in the environment.

Personal monitors based on unipolar diffusion charging (miniDiSC/DiSCmini, NanoTracer, Partector) can be used to assess the individual exposure to nanoparticles in different environments. The charge acquired by the aerosol particles is nearly proportional to the particle diameter and, by coincidence, also nearly proportional to the alveolar lung-deposited surface area (LDSA), the metric reported by all three instruments. In addition, the miniDiSC/DiSCmini and the NanoTracer report particle number concentration and mean particle size. In view of their use for personal exposure studies, the comparability of these personal monitors was assessed in two measurement campaigns. Altogether 29 different polydisperse test aerosols were generated during the two campaigns, covering a large range of particle sizes, morphologies and concentrations. The data provided by the personal monitors were compared with those obtained from reference instruments: a scanning mobility particle sizer (SMPS) for LDSA and mean particle size and a ultrafine particle counter (UCPC) for number concentration. The results indicated that the LDSA concentrations and the mean particle sizes provided by all investigated instruments in this study were in the order of ±30% of the reference value obtained from the SMPS when the particle sizes of the test aerosols generated were within 20-400nm and the instruments were properly calibrated. Particle size, morphology and concentration did not have a major effect within the aforementioned limits. The comparability of the number concentrations was found to be slightly worse and in the range of ±50% of the reference value obtained from the UCPC. In addition, a minor effect of the particle morphology on the number concentration measurements was observed. The presence of particles >400nm can drastically bias the measurement results of all instruments and all metrics determined.

Exposure of UK industrial plumbers to asbestos, Part II: Awareness and responses of plumbers to working with asbestos during a survey in parallel with personal sampling.

Throughout the European Union, millions tonnes of asbestos were used in the manufacture of products for building and for industrial installations. Today, in the UK, it is estimated that over half a million non-domestic premises alone have asbestos-containing materials in them and it is recognized that those working in building maintenance trades continue to be at significant risk. In part II, the awareness of UK plumbers to when they are working with asbestos was investigated and compared with the monitored levels reported in part I. The plumbers were issued by post with passive samplers, activity logs to monitor a working week and a questionnaire. The activity logs were used to assess whether maintenance workers were knowingly or unknowingly exposed to airborne asbestos fibres during a course of a working week. The questionnaire was designed to gather information on their: age, employment status, current and past perception of the frequency which they work with asbestos and knowledge of the precautions that should be taken to limit exposure and risk. Approximately 20% of workers reported on the sample log that they had worked with asbestos. There was a high correlation (93%) between the sampling log replies that they were knowingly working with asbestos and measured asbestos on the passive sampler. However, some 60% of the samples had >5 microm long asbestos structures found by transmission electron microscopy (TEM) analysis suggesting that the plumbers were aware of about only one-third of their contacts with asbestos materials throughout the week. This increased to just over one half of the plumbers being aware of their contact based on the results for phase contrast microscopy (PCM) countable asbestos fibres. The results from the questionnaire found that over half of the plumbers replying thought that they disturb asbestos only once a year and 90% of them thought they would work with asbestos for<10 h year-1. Their expectations and awareness of work with asbestos were therefore far lower than found during the period of monitoring. The response to an open question on the precautions to be taken, found that 61% of plumbers would avoid disturbance and 59% would use respiratory protection if they did disturb asbestos. However, their awareness of the methods and the need to reduce their risk by control of emissions at source was very low and suggests that further awareness raising and training is needed. The survey was carried out prior to the introduction of the duty to manage and gives a useful baseline to assess the impact of regulatory initiatives.

Exposure of UK industrial plumbers to asbestos, Part I: Monitoring of exposure using personal passive samplers.

Epidemiological data suggest that there has been and may continue to be a significant risk to maintenance workers, who through their work may disturb asbestos-containing materials (ACM). The sampling and assessment of maintenance workers' exposure is a particular problem because they may not know that they are working with ACM. A strategy to monitor their true exposure has been developed and applied to one group of workers. The asbestos exposure of industrial plumbers was measured using personal passive samplers developed at the Health and Safety Laboratory (HSL). The light-weight samplers, which collect particles by electrostatic attraction, are simple to use and do not require prior knowledge that asbestos is to be disturbed as does conventional sampling. The samplers were issued by post and analysed, after return, using transmission electron microscopy (TEM). The strategy was found to be a reasonably efficient and cost-effective way to obtain data on maintenance worker's exposure to asbestos. The results of the TEM analysis of the passive samplers showed that the percentage of workers exposed to >5 microm long asbestos fibres was 62% in Round 1 and 58% in Round 2. For phase contrast microscopy equivalent (PCME) asbestos fibres, the values were 46 and 29%, respectively. The three samples with the highest numbers of fibres were followed up and were associated with plumbers working in areas which had supposedly been stripped of asbestos just prior to their starting work, suggesting that poor removal, clean-up and clearance practice presents a significant part of the risk to plumbers. Although flow rates will vary with conditions and time, an approximate average sampling rate from previous comparisons was used to calculate the concentration. This gave an average exposure to regulated PCME fibres of 0.009 f ml-1 for amphibole asbestos and 0.049 f ml-1 for chrysotile. The calculate risk based on the PCME fibre types collected and their estimated concentrations, showed that the risk from airborne amphibole fibres was approximately 6 times greater than from chrysotile fibres. If representative, the estimated lifetime risk of death from an asbestos related cancer for an exposure from age 20 for 40 years would be 68 per 100,000, which equates to an annual risk of death of the order of 10 per million.

The performance of laboratories analysing alpha-quartz in the Workplace Analysis Scheme for Proficiency (WASP).

The Workplace Analysis Scheme for Proficiency (WASP) is a proficiency testing (PT) scheme for the analysis of occupational hygiene and environmental air samples and is operated in the United Kingdom by the Health and Safety Laboratory (HSL) on behalf of the Health & Safety Executive (HSE). One of the 26 analytes available to laboratories is silica (alpha-quartz) on 25 mm Gelman GLA5000 filters. This paper investigates the performance of laboratories participating in the scheme since the HSL took over the production of the samples in 1998. The average relative standard deviation (RSD) of results obtained by a laboratory is 11.5%. This is reduced to 8.5% when the values from laboratories using indirect analytical methods are excluded. Laboratories using indirect analytical methods accounted for some of the most variable data. For the on-filter analytical methods the data suggested a relationship between relative standard deviation and loading that increased gradually from +/-4% at high analyte levels to +/-10-15% at low levels. The average precision estimate for the on-filter analytical methods was found to be 5.6% RSD for the infrared technique and 6.7% RSD for the X-ray diffraction technique. These figures compare favourably with those reported in the published HSE methods. No significant difference was found between the average result reported by laboratories using on-filter infrared (IR) analysis and the average result reported by laboratories using on-filter X-ray diffraction (XRD) analysis. An ANOVA analysis found the repeatability estimate was just as large as the 'between laboratory' variation for both the XRD and IR on-filter analysis techniques. When a limited number of 'realistic' samples were included in the scheme, XRD analysis was found to perform slightly better than IR analysis. The performance of laboratories in the WASP scheme compares very favourably with other published data from a PT scheme where indirect silica analytical methods are predominately used.