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Original Articles

The Global Landscape of Occupational Exposure Limits—Implementation of Harmonization Principles to Guide Limit Selection

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REFERENCES

  • Waters, M., L. McKernan, A. Maier, M. Jayjock, V. Schaeffer, and L. Brosseau: Exposure estimation and interpretation of occupational risk: Enhanced information for the occupational risk manager. J. Occup. Environ. Hyg. 12(0):S99–S111 (2015).
  • Zielhuis, R.L., P.C. Noordam, C.L. Maas, J.J. Kolk, and H.P. Illing: Harmonization of criteria documents for standard setting in occupational health: a report of a workshop. Regul. Toxicol. Pharmacol. 13(3):241–262 (1991).
  • Paustenbach, D.J., D.M. Cowan, and J. Sahmel: The history and biological basis of occupational exposure limits for chemical agents. In Patty's Industrial Hygiene, R. V and B. Cohrssen (eds.). Hoboken, NJ: John Wiley & Sons Inc, 2011.
  • “Derivation of MAK values.” Available at: http://www.dfg.de/en/dfg_profile/statutory_bodies/senate/health_hazards/structure/working_groups/derivation_mak/index.html2013).
  • Ripple, S.: History of occupational exposure limits. Exposure Setting Processes—An International Challenge, Workshop at the International Occupational Hygiene Assocation (IOHA) Conference, Rome, Italy2010).
  • “The Nordic Expert Group.” Available at: http://www.av.se/arkiv/neg/the_neg/2013).
  • European Commission: Methodology for the Derivation of Occupational Exposure Limits: Key Documentation (Version 7). (2013).
  • Adkins, C., L. Booher, D. Culver, et al.: “Occupational exposure limits: do they have a future?” Available at http://www.ioha.net/assets/files/MASTER%20OEL%20Green_Paper%2009%2018%2009(1).pdf.
  • Paustenbach, D.J.: Occupational Exposure Limits. In ILO Encyclopaedia of Occupational Health and Safety, pp. 30.27–30.34. Geneva: International Labour Organisation, 1997.
  • Wheeler, M.W., R. Park, A.J. Bailer, and C. Whittaker: Historical context and recent advances in exposure-response estimation for deriving occupational exposure limits. J. Occup. Environ. Hyg. 12(0):S7–S17 (2015).
  • Dankovic, D.A., B.D. Naumann, A. Maier, M.L. Dourson, and L. Levy: The scientific basis of uncertainty factors used in setting occupational exposure limits. J. Occup. Environ. Hyg. 12(0):S55–S68 (2015).
  • Howard, J.: Setting occupational exposure limits: are we living in a post-OEL world? U. Pa. J. Lab. Empl. L. 7(3):513–528 (2005).
  • United States Department of Labor: Occupational Health and Safety Standards 1910.1000 Z Toxic and Hazardous Substances, Washington DC.
  • European Commission: “Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work” Available at https://osha.europa.eu/en/legislation/directives/75.
  • Salter, L., and E. Levy: In the Eye of the Storm: Case Study One: The American Conference of Governmental Industrial Hygienists. In Mandated Science: Science and Scientists in the Making of Standards, L. Salter (ed.), pp. 36–66. Dordrecht, Netherlands: Kluwer Academic Publishers, 1988.
  • Piney, M.: Exposure limits, practicability and health risks: Arguments for a paradigm shift. In The Politics of Chemical Risk: Scenarios for a Regulatory Future, R. Bal and W. Halffman (eds.), pp. 27–73. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1998.
  • Vincent, J.H.: International occupational exposure standards: a review and commentary. Am. Ind. Hyg. Assoc. J. 59:729–742 (1998).
  • Hansson, S.O.: Setting the Limit: Occupational Health Standards and the Limits of Science. New York: Oxford University Press, 1998.
  • American Conference of Governmental Industrial Hygienists (ACGIH): Sources, Abbreviations, Definitions and Terms Used Within the Database and Its Reports. In Documentation of the TLVs and BEIs with Other Worldwide Occupational Exposure Values: 2006 CD-ROM, ACGIH (ed.), pp. 1–15. Cincinnati, OH: ACGIH, 2006.
  • National Academy of Sciences (NAS): Science and Decisions: Advancing Risk Assessment. Washington, D.C.: National Academy Press, 2009.
  • Krewski, D., M. Westphal, M.E. Andersen, et al.: A framework for the next generation of risk science. Environ. Health Perspect. 122(8):796–805 (2014).
  • Laszcz-Davis, C., A. Maier, and J. Perkins: The hierarchy of OELs: A new organizing principle for occupational risk assessment. Synergist: 26–30 (March 2014).
  • Nielsen, G.D., and S. Ovrebo: Background, approaches and recent trends for setting health-based occupational exposure limits: a minireview. Regul. Toxicol. Pharmacol. 51(3):253–269 (2008).
  • Kreider, M.L., and E.S. Williams: Interpreting REACH guidance in the determination of the derived no effect level (DNEL). Regul. Toxicol. Pharmacol. 58(2):323–329 (2010).
  • Ader, A.W., J.P. Farris, and R.H. Ku: Occupational health categorization and compound handling practice systems: roots, application and future. Chem. Health Saf. 12(4):20–26 (2005).
  • American Industrial Hygiene Association (AIHA) Control Banding Working Group: Guidance for Conducting Control Banding Analyses. Fairfax, VA: AIHA, 2007.
  • Naumann, B.D.: “Control banding in the pharmaceutical industry.” Occupational Hygienists Conference Proceedings 2005. Available at: http://www.aioh.org.au/downloads/documents/ControlBandingBNaumann.pdf (accessed November 15, 2014).
  • National Institute for Occupational Safety and Health (NIOSH): Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB). DHHS (NIOSH) Publication No. 2009-152 (2009).
  • Ripple, S.: Hyped about hazard banding. Synergist: 43–45:60 (2009).
  • Zalk, D.M., and D.I. Nelson: History and evolution of control banding: a review. J. Occup. Environ. Hyg. 5(5):330–346 (2008).
  • Barlow, S.: Threshold of Toxicological Concern (TTC): A Tool for Assessing Substances of Unknown Toxicity Present at Low Levels in the Diet. Brussels, Belgium, ILSI Press, 2005.
  • Kroes, R., J. Kleiner, and A. Renwick: The threshold of toxicological concern concept in risk assessment. Toxicol. Sci. 86(2):226–230 (2005).
  • Dolan, D.G., B.D. Naumann, E.V. Sargent, A. Maier, and M. Dourson: Application of the threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul. Toxicol. Pharmacol. 43(1):1–9 (2005).
  • National Institute for Occupational Safety and Health (NIOSH): Current intelligence bulletin 66: derivation of immediately dangerous to life or health (IDLH) values. DHHS (NIOSH) Publication No. 2014–100 (2013).
  • Brandys, R.C., and G.M. Brandys: Global Occupational Exposure Limits for Over 6,000 Specific Chemicals. 2nd Edition. Hingdale, IL: Occupational and Environmental Health Consulting Services Inc., 2008.
  • Schenk, L., S.O. Hansson, C. Rudén, and M. Gilek: Occupational exposure limits: a comparative study. Regul. Toxicol. Pharmacol. 50(2):261–270 (2008).
  • Chemical Abstracts Service: “CAS REGISTRY(SM) surpasses 75 million small molecules2013).
  • “TSCA Chemical Substance Inventory: Basic Information.” Available at: http://www.epa.gov/oppt/existingchemicals/pubs/tscainventory/basic.html2013).
  • Health Canada: Proposal for Priority Setting for Existing Substances on the Domestic Substances List Under the Canadian Environmental Protection Act, 1999: Greatest Potential for Human Exposure. Ottawa, ON, Canada: Health Canada, Existing Substances Division, (2003).
  • European Chemicals Agency (ECHA): “Classification and Labelling Notification Report on 4 January.” Available at http://echa.europa.eu/documents/10162/13585/clp_final_report_20110104_en.pdf.
  • Schenk, L.: Comparison of data used for setting occupational exposure limits. Int. J. Occup. Environ. Health 16(3):249–262 (2010).
  • Chen, C.P., H.W. Ahlers, G.S. Dotson, et al.: Efficacy of predictive modeling as a scientific criterion in dermal hazard identification for assignment of skin notations. Regul. Toxicol. Pharmacol. 61(1):63–72 (2011).
  • Haber, L.T. and A. Maier: Scientific criteria used for the development of occupational exposure limits for metals and other mining-related chemicals. Regul. Toxicol. Pharmacol. 36(3):262–279 (2002).
  • United States Department of Labor: “OSH Act of 1970.” Available at https://www.osha.gov/pls/oshaweb/owasrch.search_form%3Fp_doc_type=OSHACT.
  • American Conference of Governmental Industrial Hygienists (ACGIH): 2014 TLVs and BEIs. Cincinnati, OH: ACGIH, 2014.
  • Castleman, B.I., and G.E. Ziem: Corporate influence on threshold limit values. Am. J. Ind. Med. 13(5):531–559 (1988).
  • Henschler, D.: Evaluation of adverse effects in the standard-setting process. Toxicol. Lett. 64–65:53–57 (1992).
  • United Nations Economic Commission for Europe: Globally Harmonized System of Classification and Labelling of Chemicals. Fifth revised edition. Geneva: United Nations Economic Commission for Europe, 2013.
  • ACUTEX: Methodology to develop AETLs (2006).
  • European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC): Guidance on Assessment Factors to Derive a DNEL. Technical Report No. 110. Brussels: European Centre for Ecotoxicology and Toxicology of Chemicals, 2010.
  • Illing, H.P.: Extrapolating from toxicity data to occupational exposure limits: some considerations. Ann. Occup. Hyg. 35(6):569–580 (1991).
  • Ku, R.H.: An overview of setting occupational exposure limits (OELs) for pharmaceuticals. Chem. Health Saf. 7(1):34–37 (2000).
  • Ritter, L., C. Totman, K. Krishnan, R. Carrier, A. Vezina, and V. Morisset: Deriving uncertainty factors for threshold chemical contaminants in drinking water. J. Toxicol. Environ. Health B Crit. Rev. 10(7):527–557 (2007).
  • Schenk, L., and G. Johanson: Use of uncertainty factors by the SCOEL in their derivation of health-based occupational exposure limits. Crit. Rev. Toxicol. 40(9):791–798 (2010).
  • Renwick, A.G., J.C.M. Dorne, and K. Walton: Pathway-related factors: The potential for human data to improve the scientific basis of risk assessment. Hum. Ecol. Risk Assess. 7(1):165–180 (2001).
  • International Programme on Chemical Safety (IPCS): Chemical-Specific Adjustment Factors for Interspecies Differences and Human Variability: Guidance Document for Use of Data in Dose/Concentration–Reponse Assessment. Harmonization Project Document No. 2. Bussels: IPCS, 2005.
  • European Chemicals Agency: Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. ECHA-2010-G-19-EN Helsinki, Finland: European Chemicals Agency, 2012.
  • Schenk, L., and G. Johanson: A quantitative comparison of the safety margins in the european indicative occupational exposure limits and the derived no-effect levels for workers under REACH. Toxicol. Sci. 121(2):408–416 (2011).
  • Dyck, R., M.S. Islam, A. Zargar, A. Mohapatra, and R. Sadiq: Application of data fusion in human health risk assessment for hydrocarbon mixtures on contaminated sites. Toxicology 313(2–3):160–173 (2013).
  • Islam, M.S., A. Zargar, R. Dyck, A. Mohapatra, and R. Sadiq: Data fusion-based risk assessment framework: An example of benzene. Int. J. Syst. Assur. Eng. Manage. 3(4):267–283 (2012).
  • International Programme on Chemical Safety (IPCS): Part 1: IPCS Framework for Analysing the Relevance of a Cancer Mode of Action for Humans and Case-Studies; Part 2: IPCS Framework for Analysing the Relevance of a Non-Cancer Mode of Action for Humans. Harmonization Project Document No. 4. Geneva, Switzerland: IPCS, 2007.
  • Tao, T., Y. Bhuller, Y. Bonvalot, et al.: Weight of Evidence: General Principles and Current Applications at Health Canada (2011).
  • Rhomberg, L.R., L.A. Bailey, and J.E. Goodman: Hypothesis-based weight of evidence: a tool for evaluating and communicating uncertainties and inconsistencies in the large body of evidence in proposing a carcinogenic mode of action–naphthalene as an example. Crit. Rev. Toxicol. 40(8):671–696 (2010).
  • Klimisch, H.J., M. Andreae, and U. Tillmann: A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharmacol. 25(1):1–5 (1997).
  • Money, C.D., J.A. Tomenson, M.G. Penman, P.J. Boogaard, and R.J. Lewis: A systematic approach for evaluating and scoring human data. Regul. Toxicol. Pharmacol. 66(2):241–247 (2013).
  • Chambers, A., D. Krewski, N. Birkett, et al.: An exposure-response curve for copper excess and deficiency. J. Toxicol. Environ. Health B Crit. Rev. 13(7–8):546–578 (2010).
  • Dourson, M.L., L.K. Teuschler, P.R. Durkin, and W.M. Stiteler: Categorical regression of toxicity data: a case study using aldicarb. Regul. Toxicol. Pharmacol. 25(2):121–129 (1997).
  • Tyshenko, M.G., S. El Saadany, T. Oraby, et al.: Expert elicitation for the judgment of prion disease risk uncertainties. J. Toxicol. Environ. Health A 74(2–4):261–285 (2011).
  • Lundberg, P.: National and international approaches to occupational standard setting within Europe. Appl. Occup. Environ. Hyg. 9(1):25–27 (1994).
  • Travis, C.C., and H.A. Hattemer-Frey: Determining an acceptable level of risk. Environ. Sci. Technol. 22(8):873–876 (1988).
  • United States Government Accountability Office (USGAO): Chemical risk assessment: Selected federal agencies’ procedures, assumptions, and policies. No. GAO-01-810 (2001).
  • International Programme on Chemical Safety (IPCS): “International Programme on Chemical Safety Harmonization Project Strategic Plan: Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals.” Available at: http://www.who.int/entity/ipcs/methods/harmonization/strategic_plan.pdf2013).
  • International Council on Mining and Metals: “The Setting and Use of Occupational Exposure Limits: Current Practice.” Available at https://www.icmm.com/document/17.
  • International Council on Mining and Metals: Towards a Harmonized Approach to Setting Occupational Exposure Limits: Report of an ICMM-Sponsored Workshop, London, November 9–11, 2005 (2006).
  • Mikheev, M.I.: Toward WHO-recommended occupational exposure limits. Toxicol. Lett. 77(1–3):183–187 (1995).
  • International Programme on Chemical Safety (IPCS): 1,2-Dichloroethane. Concise International Chemical Assessment Document No. 1 (1998). . Geneva: IPCS.
  • Ding, Q., L. Schenk, K. Malkiewicz, and S.O. Hansson: Occupational exposure limits in Europe and Asia–continued divergence or global harmonization? Regul. Toxicol. Pharmacol. 61(3):296–309 (2011).
  • Woodall, G.M. and R.B. Goldberg: Summary of the workshop on the power of aggregated toxicity data. Toxicol. Appl. Pharmacol. 233(1):71–75 (2008).
  • Schenk, L., S.O. Hansson, C. Rudén, and M. Gilek: Are occupational exposure limits becoming more alike within the European Union? J. Appl. Toxicol. 28(7):858–866 (2008).
  • Dourson, M.L., and J.F. Stara: Regulatory history and experimental support of uncertainty (safety) factors. Regul. Toxicol. Pharmacol. 3(3):224–238 (1983).
  • Seeley, M.R., L.E. Tonner-Navarro, B.D. Beck, et al.: Procedures for health risk assessment in Europe. Regul. Toxicol. Pharmacol. 34(2):153–169 (2001).
  • WHO: Assessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-Based Exposure Limits. Environ. Health Criteria 170 (1994).
  • Haber, L.T., J.E. Strawson, A. Maier, I.M. Baskerville-Abraham, A. Parker, and M.L. Dourson: Noncancer Risk Assessment: Principles and Practice in Environmental and Occupational Settings. In Patty's Toxicology, E. Bingham and B. Cohrssen (eds.), Hoboken, NJ: John Wiley & Sons, 2012. pp. 89–132.
  • “GESTIS International Limit Values.” Available at: http://limitvalue.ifa.dguv.de/Webform_gw.aspx2013).
  • “Chemical exposure limits.” Available at: http://www.ilo.org/safework/info/publications/WCMS_1515342013).
  • “Information on Chemicals.” Available at: http://echa.europa.eu/information-on-chemicals2013).
  • “TOXNET: Toxicology Data Network.” Available at: http://toxnet.nlm.nih.gov2013).
  • Zalk, D.M.: Control Banding: A Simplified, Qualitative Strategy for the Assessment of Risks and Selection of Solutions. Delft, Netherlands: TU Delft, 2010.
  • Brouwer, D.H.: Control banding approaches for nanomaterials. Ann. Occup. Hyg. 56(5):506–514 (2012).
  • Van Duuren-Stuurman, B., S.R. Vink, K.J. Verbist, et al.: Stoffenmanager Nano Version 1.0: a web-based tool for risk prioritization of airborne manufactured nano objects. Ann. Occup. Hyg. 56(5):525–541 (2012).
  • Zalk, D.M., S.Y. Paik, and P. Swuste: Evaluating the Control Banding Nanotool: a qualitative risk assessment method for controlling nanoparticle exposures. J. Nanopart. Res. 11(7):1685–1704 (2009).
  • National Institute for Occupational Safety and Health (NIOSH): Current Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide. DHHS (NIOSH) Publication No. 2011-160 (2011).
  • Kuempel, E., V. Castranova, C. Geraci, and P. Schulte: Development of risk-based nanomaterial groups for occupational exposure control. J. Nanopart. Res. 14(9):1–15 (2012).
  • Schulte, P., V. Murashov, R. Zumwalde, E. Kuempel, and C. Geraci: Occupational exposure limits for nanomaterials: state of the art. J. Nanopart. Res. 12(6):1971–1987 (2010).
  • Zalk, D.M., R. Kamerzell, S. Paik, J. Kapp, D. Harrington, and P. Swuste: Risk level based management system: a control banding model for occupational health and safety risk management in a highly regulated environment. Ind. Health 48(1):18–28 (2010).
  • Zalk D.M.: Participatory occupational hygiene: a path to practical solutions. Asia. Pac. Newsl. Occup. Health Saf. 9(3):51 (2002).