Validation of the inhalable dust algorithm of the Advanced REACH Tool using a dataset from the pharmaceutical industry.

As it is often difficult to obtain sufficient numbers of measurements to adequately characterise exposure levels, occupational exposure models may be useful tools in the exposure assessment process. This study aims to refine and validate the inhalable dust algorithm of the Advanced REACH Tool (ART) to predict airborne exposure of workers in the pharmaceutical industry. The ART was refined to reflect pharmaceutical situations. Largely task based workplace exposure data (n = 192) were collated from a multinational pharmaceutical company with exposure levels ranging from 5 × 10(-5) to 12 mg m(-3). Bias, relative bias and uncertainty around geometric mean exposure estimates were calculated for 16 exposure scenarios. For 12 of the 16 scenarios the ART geometric mean exposure estimates were lower than measured exposure levels with on average, a one-third underestimation of exposure (relative bias -32%). For 75% of the scenarios the exposure estimates were, within the 90% uncertainty factor of 4.4, as reported for the original calibration study, which may indicate more uncertainty in the ART estimates in this industry. While the uncertainty was higher than expected this is likely due to the limited number of measurements per scenario, which were largely derived from single premises.

[1]  Hans Kromhout,et al.  Tools for regulatory assessment of occupational exposure: development and challenges , 2007, Journal of Exposure Science and Environmental Epidemiology.

[2]  John W Cherrie,et al.  The validity of the EASE expert system for inhalation exposures. , 2005, The Annals of occupational hygiene.

[3]  K Teschke,et al.  Predicting Historical Dust and Wood Dust Exposure in Sawmills: Model Development and Validation , 2005, Journal of occupational and environmental hygiene.

[4]  Erik Tielemans,et al.  'Stoffenmanager', a web-based control banding tool using an exposure process model. , 2008, The Annals of occupational hygiene.

[5]  Mitchell S. Wilbanks,et al.  EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS , 2005 .

[6]  Hans Kromhout,et al.  Conceptual model for assessment of inhalation exposure: defining modifying factors. , 2008, The Annals of occupational hygiene.

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

[8]  R. Hornung,et al.  Estimation of Average Concentration in the Presence of Nondetectable Values , 1990 .

[9]  John W. Cherrie,et al.  Variability and uncertainty in chemical exposures for regulatory risk assessments , 2004 .

[10]  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.

[11]  D. Christiani,et al.  Modeling, estimation and validation of cotton dust and endotoxin exposures in Chinese textile operations. , 2006, The Annals of occupational hygiene.

[12]  Hans Kromhout,et al.  Advanced REACH Tool (ART): calibration of the mechanistic model. , 2011, Journal of environmental monitoring : JEM.

[13]  W. Chan,et al.  A meta-analytic approach for characterizing the within-worker and between-worker sources of variation in occupational exposure. , 2006, The Annals of occupational hygiene.

[14]  Mark J. Nieuwenhuijsen,et al.  Human exposure modelling for chemical risk assessment: a review of current approaches and research and policy implications , 2006 .

[15]  J. Cerhan,et al.  Epidemiologic Evaluation of Measurement Data in the Presence of Detection Limits , 2004, Environmental Health Perspectives.

[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]  E. Symanski,et al.  A comprehensive evaluation of within- and between-worker components of occupational exposure to chemical agents. , 1993, The Annals of occupational hygiene.