Hans Marquart
Research interests
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InterestsOccupational Health, Industrial Hygiene, chemical exposure assessment
Publications
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1.80Impact points
A structured approach to Exposure Based Waiving of human health endpoints under REACH developed in the OSIRIS project.
Regulatory toxicology and pharmacology : RTP. 12/2011; 62(2):231-40.
Exposure Based Waiving (EBW) is one of the options in REACH when there is insufficient hazard data on a specific endpoint. Rules for adaptation of test requirements are specified and a general option for EBW is given via Appendix XI of REACH, allowing waiving of repeated dose toxicity studies, repro... [more] Exposure Based Waiving (EBW) is one of the options in REACH when there is insufficient hazard data on a specific endpoint. Rules for adaptation of test requirements are specified and a general option for EBW is given via Appendix XI of REACH, allowing waiving of repeated dose toxicity studies, reproductive toxicity studies and carcinogenicity studies under a number of conditions if exposure is very low. A decision tree is described that was developed in the European project OSIRIS (Optimised Strategies for Risk Assessment of Industrial Chemicals through Integration of Non-Test and Test Information) to help decide in what cases EBW can be justified. The decision tree uses specific criteria as well as more general questions. For the latter, guidance on interpretation and resulting conclusions is provided. Criteria and guidance are partly based on an expert elicitation process. Among the specific criteria a number of proposed Thresholds of Toxicological Concern are used. The decision tree, expanded with specific parts on absorption, distribution, metabolism and excretion that are not described in this paper, is implemented in the OSIRIS webtool on integrated testing strategies.
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1.91Impact points
Classification of occupational activities for assessment of inhalation exposure.
The Annals of occupational hygiene. 09/2011; 55(9):989-1005.
There is a large variety of activities in workplaces that can lead to emission of substances. Coding systems based on determinants of emission have so far not been developed. In this paper, a system of Activity Classes and Activity Subclasses is proposed for categorizing activities involving chemica... [more] There is a large variety of activities in workplaces that can lead to emission of substances. Coding systems based on determinants of emission have so far not been developed. In this paper, a system of Activity Classes and Activity Subclasses is proposed for categorizing activities involving chemical use. Activity Classes share their so-called 'emission generation mechanisms' and physical state of the product handled and the underlying determinants of emission. A number of (industrial) stakeholders actively participated in testing and fine-tuning the system. With the help of these stakeholders, it was found to be relatively easy to allocate a large number of activities to the Activity Classes and Activity Subclasses. The system facilitates a more structured classification of activities in exposure databases, a structured analysis of the analogy of exposure activities, and a transparent quantification of the activity emission potential in (new) exposure assessment models. The first use of the system is in the Advanced REACH Tool.
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1.80Impact points
Exposure-based waiving under REACH.
Regulatory toxicology and pharmacology : RTP. 12/2010; 58(3):408-20.
Within the REACH framework, but also within OECD, there is understanding that for reasons of animal welfare, costs and logistics, it is important to limit the number of tests to be conducted. Exposure-based waiving (EBW) is a potentially important element in testing strategies. This publication desc... [more] Within the REACH framework, but also within OECD, there is understanding that for reasons of animal welfare, costs and logistics, it is important to limit the number of tests to be conducted. Exposure-based waiving (EBW) is a potentially important element in testing strategies. This publication describes criteria for exposure-based waiving as foreseen in the REACH regulation and gives more detail to the REACH requirements for exposure-based waiving The principle behind any EBW is that there are situations when human or environmental exposures are so low or infrequent that there is a very low probability that the acquisition of additional effect information may lead to an improvement in the ability to manage risk. EBW therefore is risk-based and needs thorough knowledge on exposure as well as on effects criteria. Both elements are discussed: exposure models are analysed and the uncertainty in their predictions discussed as well as no-effect criteria such as the threshold of toxicological concern. Examples of EBW are provided for environmental, consumer and worker exposure. REACH only allows EBW in a limited number of cases with constraints on tonnage levels, types of tests to be waived and the need for a thorough ES and exposure assessment throughout the life cycle of a chemical and for all human exposure routes and environmental pathways. EBW will only be considered a real option by industry if a cost-benefit analysis shows an advantage, which may heavily depend on the weighing factor one applies for the non-use of experimental animals.
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1.80Impact points
Use of read-across and tiered exposure assessment in risk assessment under REACH--a case study on a phase-in substance.
Regulatory toxicology and pharmacology : RTP. 10/2010; 58(1):64-71.
REACH requests the exploration of alternative strategies for hazard identification before resorting to (in vivo) testing. Here, we combined read-across as non-testing strategy with a tiered exposure assessment for the risk characterisation of 1-methoxypropan-2-ol (PGME) as a representative for phase... [more] REACH requests the exploration of alternative strategies for hazard identification before resorting to (in vivo) testing. Here, we combined read-across as non-testing strategy with a tiered exposure assessment for the risk characterisation of 1-methoxypropan-2-ol (PGME) as a representative for phase-in substances to be registered under REACH. Read-across from the selected source substances provided data which were comparable with experimental data available for target substance PGME, resulting in a realistic starting point for both qualitative and quantitative risk assessment. Greater variability was observed in the exposure estimates from a first Tier model (ECETOC TRA) or less conservative further Tier models (Stoffenmanager; RISKOFDERM), when these results were compared with results from a data-rich approach using measured data. When safe use of chemicals cannot be demonstrated with these approaches, refinement can be introduced in the estimation of hazard and exposure, or both. In view of the variability associated with exposure modeling, it may often add more value to invest in realistic exposure data than in toxicity studies, apart from animal welfare considerations.
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3.64Impact points
Cross-validation and refinement of the Stoffenmanager as a first tier exposure assessment tool for REACH.
Occupational and environmental medicine. 09/2009;
OBJECTIVES: For regulatory risk assessment under REACH a tiered approach is proposed in which the first tier models should provide a conservative exposure estimate that can discriminate between scenarios of concern and those which are not. The Stoffenmanager is mentioned as first tier approach in th... [more] OBJECTIVES: For regulatory risk assessment under REACH a tiered approach is proposed in which the first tier models should provide a conservative exposure estimate that can discriminate between scenarios of concern and those which are not. The Stoffenmanager is mentioned as first tier approach in the REACH guidance. In an attempt to investigate the validity of the Stoffenmanager algorithms a cross-validation study was performed. METHODS: Exposure estimates using the Stoffenmanager algorithms were compared with exposure measurement results (n=254). Correlations between observed and predicted exposures, bias and precision were calculated. Stratified analyses were performed for the scenarios "handling of powders and granules" (n=82), "handling solids resulting in comminuting" (n=60), "handling of low-volatile liquids" (n=40) and for "handling of volatile liquids" (n=72). RESULTS: The relative bias of the 4 algorithms ranged between -9% and -77% with a precision of approximately 1.7. The 90-percentile estimate of 1 out of 4 algorithms was not conservative enough. Based on these statistics and analyses of residual plots the underlying algorithm was adapted. Subsequently, the calibration and the cross-validation dataset were merged to one dataset (n=952) used for calibrating the adapted Stoffenmanager algorithms. This new calibration resulted in new exposure algorithms for the 4 scenarios. CONCLUSIONS: The Stoffenmanager is capable of discriminating among exposure levels mainly between scenarios in different companies. The 90-percentile estimates of the Stoffenmanager are verified to be sufficiently conservative. Therefore, the Stoffenmanager could be a useful Tier 1 exposure assessment tool for REACH.
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1.91Impact points
'Stoffenmanager', a Web-Based Control Banding Tool Using an Exposure Process Model.
The Annals of occupational hygiene. 07/2008;
In the scope of a Dutch programme to reinforce the working conditions policy on hazardous substances, an internet-based tool was developed to help small- and medium-sized companies to handle hazardous substances with more care. The heart of this tool, called the Stoffenmanager, is a risk banding sch... [more] In the scope of a Dutch programme to reinforce the working conditions policy on hazardous substances, an internet-based tool was developed to help small- and medium-sized companies to handle hazardous substances with more care. The heart of this tool, called the Stoffenmanager, is a risk banding scheme. It combines a hazard banding scheme similar to that of COSHH Essentials and an exposure banding scheme based on an exposure model originally presented by Cherrie et al. (1996) and further developed by Cherrie and Schneider (1999). The exposure model has been modified to allow non-expert users to understand and use the model. Exposure scores are calculated based on categorization of determinants of emission, transmission and immission. These exposure scores are assigned to exposure bands. The comparison of exposure bands and hazard bands leads to a risk band or priority band. Following the evaluation of the priority of tasks done with products, generic exposure control measures can be evaluated for their possibility to lower the risks. Relevant control measures can be put into an action plan and into workplace instruction cards. The tool has several other functionalities regarding registration and storage of products. The exposure model in the Stoffenmanager leads to exposure scores. These have been compared with measured exposure levels. The exposure scores correlated well with measured exposure levels. The development of the Stoffenmanager has facilitated a whole range of further developments of useful tools for small- and medium-sized enterprises.
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2.72Impact points
Exposure scenarios for workers.
Journal of exposure science & environmental epidemiology. 01/2008; 17 Suppl 1:S16-25.
The new European chemicals legislation REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) requires the development of Exposure Scenarios describing the conditions and risk management measures needed for the safe use of chemicals. Such Exposure Scenarios should integrate con... [more] The new European chemicals legislation REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) requires the development of Exposure Scenarios describing the conditions and risk management measures needed for the safe use of chemicals. Such Exposure Scenarios should integrate considerations of both human health and the environment. Specific aspects are relevant for worker exposure. Gathering information on the uses of the chemical is an important step in developing an Exposure Scenario. In-house information at manufacturers is an important source. Downstream users can contribute information through direct contact or through their associations. Relatively simple approaches (Tier 1 tools, such as the ECETOC Targeted Risk Assessment and the model EASE) can be used to develop broad Exposure Scenarios that cover many use situations. These approaches rely on the categorisation of just a few determinants, including only a small number of risk management measures. Such approaches have a limited discriminatory power and are rather conservative. When the hazard of the substance or the complexity of the exposure situation require a more in-depth approach, further development of the Exposure Scenarios with Tier 2 approaches is needed. Measured data sets of worker exposure are very valuable in a Tier 2 approach. Some downstream user associations have attempted to build Exposure Scenarios based on measured data sets. Generic Tier 2 tools for developing Exposure Scenarios do not exist yet. To enable efficient development of the worker exposure part of Exposure Scenarios a further development of Tier 1 and Tier 2 tools is needed. Special attention should be given to user friendliness and to the validity (boundaries) of the approaches. The development of standard worker exposure descriptions or full Exposure Scenarios by downstream user branches in cooperation with manufacturers and importers is recommended.
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1.91Impact points
Task-based dermal exposure models for regulatory risk assessment.
The Annals of occupational hygiene. 08/2006; 50(5):491-503.
The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of ne... [more] The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of new measurements of dermal exposure together with detailed contextual information. This article describes the development of a set of generic task-based models capable of predicting potential dermal exposure to both solids and liquids in a wide range of situations. To facilitate modelling of the wide variety of dermal exposure situations six separate models were made for groupings of exposure scenarios called Dermal Exposure Operation units (DEO units). These task-based groupings cluster exposure scenarios with regard to the expected routes of dermal exposure and the expected influence of exposure determinants. Within these groupings linear mixed effect models were used to estimate the influence of various exposure determinants and to estimate components of variance. The models predict median potential dermal exposure rates for the hands and the rest of the body from the values of relevant exposure determinants. These rates are expressed as mg or microl product per minute. Using these median potential dermal exposure rates and an accompanying geometric standard deviation allows a range of exposure percentiles to be calculated.
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1.91Impact points
Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments.
The Annals of occupational hygiene. 07/2006; 50(5):469-89.
Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with info... [more] Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with information on possible determinants of exposure. These data and information, together with some non-RISKOFDERM data were used to derive default values for potential dermal exposure of the hands for so-called 'TGD exposure scenarios'. TGD exposure scenarios have similar values for some very important determinant(s) of dermal exposure, such as amount of substance used. They form narrower bands within the so-called 'RISKOFDERM scenarios', which cluster exposure situations according to the same purpose of use of the products. The RISKOFDERM scenarios in turn are narrower bands within the so-called Dermal Exposure Operation units (DEO units) that were defined in the RISKOFDERM project to cluster situations with similar exposure processes and exposure routes. Default values for both reasonable worst case situations and typical situations were derived, both for single datasets and, where possible, for combined datasets that fit the same TGD exposure scenario. The following reasonable worst case potential hand exposures were derived from combined datasets: (i) loading and filling of large containers (or mixers) with large amounts (many litres) of liquids: 11,500 mg per scenario (14 mg cm(-2) per scenario with surface of the hands assumed to be 820 cm(2)); (ii) careful mixing of small quantities (tens of grams in <1l): 4.1 mg per scenario (0.005 mg cm(-2) per scenario); (iii) spreading of (viscous) liquids with a comb on a large surface area: 130 mg per scenario (0.16 mg cm(-2) per scenario); (iv) brushing and rolling of (relatively viscous) liquid products on surfaces: 6500 mg per scenario (8 mg cm(-2) per scenario) and (v) spraying large amounts of liquids (paints, cleaning products) on large areas: 12,000 mg per scenario (14 mg cm(-2) per scenario). These default values are considered useful for estimating exposure for similar substances in similar situations with low uncertainty. Several other default values based on single datasets can also be used, but lead to estimates with a higher uncertainty, due to their more limited basis. Sufficient analogy in all described parameters of the scenario, including duration, is needed to enable proper use of the default values. The default values lead to similar estimates as the RISKOFDERM dermal exposure model that was based on the same datasets, but uses very different parameters. Both approaches are preferred over older general models, such as EASE, that are not based on data from actual dermal exposure situations.
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1.91Impact points
RISKOFDERM: risk assessment of occupational dermal exposure to chemicals. An introduction to a series of papers on the development of a toolkit.
The Annals of occupational hygiene. 12/2003; 47(8):595-8.
Dermal exposure to industrial chemicals during work is of major concern in the risk assessment of chemicals. Current approaches in procedures for European legislation are not based on experimental data on dermal exposures in workplaces because these are lacking. A large project, with four interrelat... [more] Dermal exposure to industrial chemicals during work is of major concern in the risk assessment of chemicals. Current approaches in procedures for European legislation are not based on experimental data on dermal exposures in workplaces because these are lacking. A large project, with four interrelated work parts, was funded by the European Commission (DG Research) in order to overcome large parts of this problem. The 4 year project is now in its final year and an overview is given of an important part of the project: the development of a risk assessment and risk management toolkit for dermal exposure. Five other papers in this issue deal with various aspects of this development.
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1.88Impact points
Removing pesticides from the hands with a simple washing procedure using soap and water.
Journal of occupational and environmental medicine / American College of Occupational and Environmental Medicine. 12/2002; 44(11):1075-82.
Crop activities lead to dermal exposure of workers to pesticides. The efficacy of hand washing as a control measure is unknown. The efficacy of water and soap was studied for some pesticides and exposure situations. Pre-washing contamination levels in field studies were calculated from foliar residu... [more] Crop activities lead to dermal exposure of workers to pesticides. The efficacy of hand washing as a control measure is unknown. The efficacy of water and soap was studied for some pesticides and exposure situations. Pre-washing contamination levels in field studies were calculated from foliar residues by models using transfer factors. Between 24.5% and 50.7% of the calculated prewashing contamination was removed in two field studies with three pesticides, with coefficients of variation between 43% and 72%. In a human volunteer study, on average 45.8% and 85.7% was removed for two pesticides (coefficients of variation 6% and 7%). No influence of 'washing vigour' was found and efficacy did not depend on pre-washing contamination levels. The combination of field studies and laboratory experiments was successful, partly compensating for weaknesses in both approaches.
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1.91Impact points
Excluding exposure data of very poor quality is a core principle for regulatory risk assessment.
The Annals of occupational hygiene. 09/2002; 46(6):559-60; author reply 560.
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1.91Impact points
A proposal for evaluation of exposure data.
The Annals of occupational hygiene. 05/2002; 46(3):287-97.
There is a growing need for transparency concerning ways in which existing exposure data are weighted for their relative value and quality. Currently, this evaluation is largely subjective and is dependent on the quality of the judgement of the individual assessor or expert group. In this paper some... [more] There is a growing need for transparency concerning ways in which existing exposure data are weighted for their relative value and quality. Currently, this evaluation is largely subjective and is dependent on the quality of the judgement of the individual assessor or expert group. In this paper some general guidelines are presented for a quality assessment procedure. Such a predetermined procedure potentially enhances the consistency among different assessors and assessments and facilitates harmonization of assessment procedures. The guidelines are presented in the context of a decision tree with four decision rules for data quality, i.e. 'availability of occupational hygiene information', 'variability and precision issues', 'internal validity' and 'external validity'. These methodological issues are considered to be the most important aspects of data quality and will be discussed in this paper. The decision tree eventually results in three quality classes, i.e. exposure data providing sufficient information, supplementary information and data which should be excluded from the exposure assessment process. The guidelines should not be used in a rigid manner but have to be interpreted in the light of the particular circumstances and purposes of the assessment.
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1.91Impact points
Proposal for an approach with default values for the protection offered by PPE, under European new or existing substance regulations.
The Annals of occupational hygiene. 11/2001; 45(7):543-53.
Introduction of personal protective equipment (PPE) in the process of quantitative exposure and risk assessment should be addressed carefully. PPE which have been designed and manufactured according to CE-criteria and have proved to pass relevant test criteria, can be classified as "proper func... [more] Introduction of personal protective equipment (PPE) in the process of quantitative exposure and risk assessment should be addressed carefully. PPE which have been designed and manufactured according to CE-criteria and have proved to pass relevant test criteria, can be classified as "proper functioning". However, test criteria for PPE are not equal to levels of protection which can be achieved in the workplace, because actual workplace exposure scenarios, fit, maintenance and storage may differ substantially from the test conditions.The proper use of PPE is related to issues which form a part of a PPE-programme. Such a programme should be implemented in a company to ensure selection of proper PPE and information, training and instruction of employees how to wear PPE properly.Assigned protection factors (APFs) for different designs of respiratory protective devices (RPD) have been introduced to quantify effectiveness of RPD in the workplace. Similar APFs are proposed for dermal protection (gloves and clothing). In general biological monitoring studies show lower reduction of internal exposure than estimated by reduction of external exposure. Therefore, conservative estimates of protection by PPE, i.e. the lowest APFs, are proposed for risk assessment purposes if "proper use of proper functioning" PPE as part of a PPE-programme cannot be demonstrated.
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Occupational exposure information needs for regulatory risk assessment of existing chemicals.
Applied occupational and environmental hygiene. 03/2001; 16(2):315-8.
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Assessing reasonable worst-case full-shift exposure levels from data of variable quality.
Applied occupational and environmental hygiene. 03/2001; 16(2):210-7.
Exposure assessors involved in regulatory risk assessments often need to estimate a reasonable worst-case full-shift exposure level from very limited exposure information. Full-shift exposure data of very high quality are rare. A full-shift value can also be calculated from (short term) task-based v... [more] Exposure assessors involved in regulatory risk assessments often need to estimate a reasonable worst-case full-shift exposure level from very limited exposure information. Full-shift exposure data of very high quality are rare. A full-shift value can also be calculated from (short term) task-based values, either derived from measured data or from models. The most simple option is to use the task based exposure levels as the full-shift value. A second option is to calculate a time-weighted average (TWA), using (reasonable worst case) estimates of the duration and the exposure level of the relevant tasks. The third option is to use a Monte Carlo analysis with estimated input distributions for exposure level and duration of exposure. If an estimated distribution of respiratory volume is also included, this leads to a distribution of inhaled amounts. The 90th percentile of such a distribution is generally substantially lower than the fixed point estimates calculated using high end values for each parameter. This technique can thus prevent unnecessary conservative estimates in risk assessment. The output distribution can also be used as valuable input to the risk management process, because it provides information on probabilities of exposure levels, that can influence the cost-benefit analysis of the risk management process. Finally, the sensitivity analysis of Monte Carlo simulation can give guidance for further studies to increase the accuracy of the exposure assessment.
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Harmonization of future needs for dermal exposure assessment and modeling: a workshop report.
Applied occupational and environmental hygiene. 03/2001; 16(2):218-27.
Dermal exposure assessment and modeling is still in early phases of development. This article presents the results of a workshop organized to harmonize the future needs in this field. Methods for dermal exposure assessment either assess the mass of contaminant that is transferred to the skin, or the... [more] Dermal exposure assessment and modeling is still in early phases of development. This article presents the results of a workshop organized to harmonize the future needs in this field. Methods for dermal exposure assessment either assess the mass of contaminant that is transferred to the skin, or the transfer of contaminant through the skin. Models for dermal exposure are either knowledge-based or deterministic. Any method or model should be transparent, validated, and open to further development. Some (partly) validated and standardized methods are available for measuring or modeling permeation of the skin or of personal protective equipment (PPE). Further validation and standardization is necessary. More research is needed on permeation of dusts and aerosols and more realistic tests should be developed and used for PPE. Several methods have been developed to measure contamination of surfaces or skin, but they are not validated or standardized. A number of non-validated models exist to assess dermal exposure. A clear need exists for more studies of dermal exposure, regarding measurement methods, models and actual exposure levels. A running four-year European study will greatly expand the knowledge in this field. Simple tools to assess and control the risks of dermal exposure in small and medium sized enterprises are also needed. Increasing the general knowledge of practitioners (e.g., safety professionals, occupational hygienists and physicians) in the field of dermal exposure is a first requirement. Available data, for example, on the permeation of PPE, should be made more readily available, using modern information technology. When information on dermal exposure is gathered and stored, the core information needs are partly the same as those for inhalation exposure. Some elements of process and activity, substance and product or worker, specific for dermal exposure, have been suggested by the workshop.
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1.74Impact points
Risk assessment of dermal exposure of greenhouse workers to pesticides after re-entry.
Archives of environmental contamination and toxicology. 11/1992; 23(3):273-80.
On 18 farms for rose culture in greenhouses in The Netherlands, dermal exposure of hands and forearms to abamectin (avermectin B1), dodemorph (4-cyclododecyl-2,6-dimethylmorpholinium acetate) and bupirimate (5-butyl-2-(ethylamino)-6-methyl-4-pyrimidinyl dimethylsulphate) was measured during crop act... [more] On 18 farms for rose culture in greenhouses in The Netherlands, dermal exposure of hands and forearms to abamectin (avermectin B1), dodemorph (4-cyclododecyl-2,6-dimethylmorpholinium acetate) and bupirimate (5-butyl-2-(ethylamino)-6-methyl-4-pyrimidinyl dimethylsulphate) was measured during crop activities. Dermal exposure during cutting (75 workers) amounted to 13 micrograms/h, 1.8 mg/h, and 2.2 mg/h for abamectin, dodemorph and bupirimate, respectively. Dermal exposure to abamectin and dodemorph during sorting (21 workers) and bundling (30 workers) was comparable with that during cutting. From the dependence of dermal exposure on the amount of dislodgeable foliar residue (DFR) a transfer factor was estimated to be 1,200, 4,550, and 2,400 cm2/h for abamectin, dodemorph and bupirimate, respectively. For sorting and bundling these factors were of the same order of magnitude. The results suggested that work rate was also a determinant of dermal exposure. The within-farm variance of dermal exposure during cutting appeared to account for approximately 30% of the unexplained part of the variation remaining after regression on DFR and application technique. The final unexplained part in the variation of dermal exposure during cutting was amongst others due to the variation between the different farms in which the measurements were performed. A health risk evaluation of the observed levels of dermal exposure after re-entry of greenhouses led to the conclusion that a health hazard may exist, especially after application of high rates of relatively toxic pesticides which easily penetrate the skin.
Following (2)
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Theo Vermeire
RIVM -
Martin Tischer
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
Topics (1)
