Validation of Lower Tier Exposure Tools Used for REACH: Comparison of Tools Estimates With Available Exposure Measurements

Background Tier 1 exposure tools recommended for use under REACH are designed to easily identify situations that may pose a risk to health through conservative exposure predictions. However, no comprehensive evaluation of the performance of the lower tier tools has previously been carried out. The ETEAM project aimed to evaluate several lower tier exposure tools (ECETOC TRA, MEASE, and EMKG-EXPO-TOOL) as well as one higher tier tool (STOFFENMANAGER®). This paper describes the results of the external validation of tool estimates using measurement data. Methods Measurement data were collected from a range of providers, both in Europe and United States, together with contextual information. Individual measurement and aggregated measurement data were obtained. The contextual information was coded into the tools to obtain exposure estimates. Results were expressed as percentage of measurements exceeding the tool estimates and presented by exposure category (non-volatile liquid, volatile liquid, metal abrasion, metal processing, and powder handling). We also explored tool performance for different process activities as well as different scenario conditions and exposure levels. Results In total, results from nearly 4000 measurements were obtained, with the majority for the use of volatile liquids and powder handling. The comparisons of measurement results with tool estimates suggest that the tools are generally conservative. However, the tools were more conservative when estimating exposure from powder handling compared to volatile liquids and other exposure categories. In addition, results suggested that tool performance varies between process activities and scenario conditions. For example, tools were less conservative when estimating exposure during activities involving tabletting, compression, extrusion, pelletisation, granulation (common process activity PROC14) and transfer of substance or mixture (charging and discharging) at non-dedicated facilities (PROC8a; powder handling only). With the exception of STOFFENMANAGER® (for estimating exposure during powder handling), the tools were less conservative for scenarios with lower estimated exposure levels. Conclusions This is the most comprehensive evaluation of the performance of REACH exposure tools carried out to date. The results show that, although generally conservative, the tools may not always achieve the performance specified in the REACH guidance, i.e. using the 75th or 90th percentile of the exposure distribution for the risk characterisation. Ongoing development, adjustment, and recalibration of the tools with new measurement data are essential to ensure adequate characterisation and control of worker exposure to hazardous substances.

[1]  Hans Kromhout,et al.  Advanced REACH Tool (ART): overview of version 1.0 and research needs. , 2011, The Annals of occupational hygiene.

[2]  H. Kromhout,et al.  Cross-validation and refinement of the Stoffenmanager as a first tier exposure assessment tool for REACH , 2009, Occupational and Environmental Medicine.

[3]  S Bredendiek-Kämper,et al.  Do EASE scenarios fit workplace reality? A validation study of the EASE model. Estimation and Assessment of Substance Exposure. , 2001, Applied occupational and environmental hygiene.

[4]  Martin Harper,et al.  Evaluation of COSHH essentials: methylene chloride, isopropanol, and acetone exposures in a small printing plant. , 2009, The Annals of occupational hygiene.

[5]  Wouter Fransman,et al.  Use of the MEGA exposure database for the validation of the Stoffenmanager model. , 2012, The Annals of occupational hygiene.

[6]  John W Cherrie,et al.  Comparison of measured dermal dust exposures with predicted exposures given by the EASE expert system. , 2005, The Annals of occupational hygiene.

[7]  S. Maidment.  Occupational hygiene considerations in the development of a structured approach to select chemical control strategies. , 1998, The Annals of occupational hygiene.

[8]  John W Cherrie,et al.  Refinement and validation of an exposure model for the pharmaceutical industry. , 2011, Journal of environmental monitoring : JEM.

[9]  H Marquart,et al.  Use of read-across and tiered exposure assessment in risk assessment under REACH--a case study on a phase-in substance. , 2010, Regulatory toxicology and pharmacology : RTP.

[10]  Hans Kromhout,et al.  Design of measurement strategies for workplace exposures , 2002, Occupational and environmental medicine.

[11]  T. Schneider,et al.  Validation of a New Method for Structured Subjective Assessment of Past Concentrations , 1999 .

[12]  M. Nealley,et al.  Evaluation of recommended REACH exposure modeling tools and near-field, far-field model in assessing occupational exposure to toluene from spray paint. , 2013, The Annals of occupational hygiene.

[13]  J Tickner,et al.  Evaluation and further development of EASE model 2.0. , 2005, The Annals of occupational hygiene.

[14]  W. Fransman,et al.  Development and evaluation of an exposure control efficacy library (ECEL). , 2008, The Annals of occupational hygiene.

[15]  Martie van Tongeren,et al.  ETEAM Project: An overview of the project background and methodology , 2017 .

[16]  M Tischer,et al.  Evaluation of the HSE COSHH Essentials exposure predictive model on the basis of BAuA field studies and existing substances exposure data. , 2003, The Annals of occupational hygiene.

[17]  M Gérin,et al.  Monte Carlo simulation to reconstruct formaldehyde exposure levels from summary parameters reported in the literature. , 2007, The Annals of occupational hygiene.

[18]  Hans Kromhout,et al.  Trends in inhalation exposure--a review of the data in the published scientific literature. , 2007, The Annals of occupational hygiene.

[19]  Hans Marquart,et al.  Exposure scenarios for workers , 2007, Journal of Exposure Science and Environmental Epidemiology.

[20]  Karen L Johnston,et al.  Evaluation of an artificial intelligence program for estimating occupational exposures. , 2005, The Annals of occupational hygiene.

[21]  S. C. Maidment.  Occupational Hygiene Considerations in the Development of a Structured Approach to Select Chemical Control Strategies , 1998 .

[22]  Wouter Fransman,et al.  Stoffenmanager exposure model: development of a quantitative algorithm. , 2008, The Annals of occupational hygiene.

[23]  Rachael M. Jones,et al.  Evaluation of COSHH Essentials for vapor degreasing and bag filling operations. , 2006, The Annals of occupational hygiene.

[24]  Sławomir Czerczak,et al.  Evaluation of the TRA ECETOC model for inhalation workplace exposure to different organic solvents for selected process categories , 2011, International journal of occupational medicine and environmental health.

[25]  Martin Harper,et al.  Evaluation of the COSHH Essentials Model with a Mixture of Organic Chemicals at a Medium-Sized Paint Producer , 2010, The Annals of occupational hygiene.