Skip to main content
SpringerLink
Log in

Regulating Risk of Nanomaterials for Workers through Soft Law Approach

  • Original Research Paper
  • Published:
NanoEthics Aims and scope Submit manuscript

Abstract

Nanotechnology has revolutionized various industries and has become a notable catalyst for economic growth. The emerging issues of human health and safety associated with nanotechnology development have raised regulatory concerns worldwide. In occupational settings, the same novel characteristics of nanomaterials that are utilized for innovation may also be the source of toxins with adverse health effects for workers. The existing regulatory framework may function effectively to regulate chemical substances in their conventional forms but may not be adequate with regard to the specific issues of nanoform substances. A foundation of knowledge concerning properties of nanomaterials, and risk management approaches for these materials have been established, but conclusive results remain elusive. It is difficult for lawmakers to regulate nanotechnology-related activities effectively if conventional regulatory mechanisms are applied. The present article analyses in a country study the adequacy of existing Malaysian occupational safety and health law with regard to the specific issues presented by nanotechnology. The applicable regulatory approaches are examined to justify the adoption of soft law instruments as regulatory mechanisms for nanotechnology. A number of soft law best practices are briefly discussed as a basis to recommend practical solutions to close the existing regulatory gap.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. Section 4, OSHA 1994

  2. Section 15(1), OSHA 1994

  3. Section 1, OSHA 1994

  4. Part II, USECHH Regulation 2000

  5. Part III, USECHH Regulation 2000

  6. Part IV, USECHH Regulation 2000

  7. Part V, USECHH Regulation 2000

  8. Part VI, USECHH Regulation 2000

  9. Part VII, USECHH Regulation 2000

  10. Part VIII, USECHH Regulation 2000

  11. Part IX, USECHH Regulation 2000

  12. Regulation 3, USECHH Regulation 2000

  13. Regulation 2, USECHH Regulation 2000

  14. Regulation 2, CLASS Regulation 2013

  15. Part II, CLASS Regulation 2013

  16. Part III, CLASS Regulation 2013

  17. Part IV, CLASS Regulation 2013

  18. Part V, CLASS Regulation 2013

  19. Regulation 14, CLASS Regulation 2013

  20. Section 24(1) OSHA 1994

  21. Section 30 OSHA 1994

  22. Section 2 OSHA 1994

  23. Regulation 2 USECHH Regulation

  24. Regulation 3 CLASS Regulation

  25. Regulation 14 CLASS Regulation

  26. Schedule 1, USECHH Regulation

  27. Regulation 3, Occupational Safety and Health (Control of Industrial Major Accident Hazards) Regulations 1996

  28. Regulation 2(2)(b) CLASS Regulation

  29. Regulation 13 CLASS Regulation

  30. Section 3 OSHA 1994

  31. Section 30 OSHA 1994

  32. Thong Foo Ching & Ors v Shigenori Ono [1998] 4 CLJ 674

  33. Zakaria bin Abdullah & Ors v Lembaga Perlesenan Tenaga Atom & Ors [2013] 5 MLJ 206

  34. Ketua Pengarah Jabatan Alam Sekitar & Anor v Kajing Tubek & Ors and Other Appeals [1997] 4 CLJ 253 CA

  35. Zaifa Otomobil Sdn Bhd v Sarju Khetshi Popat and Anor [2009] MLJU 662

  36. [2008] 2 MLJ 450

References

  1. Allied Market Research (2016) Nanomaterials Market - Global Opportunity Analysis and Industry Forecast 2014-2022. Allied Market Research, September 2016

  2. Peixe TS, de Souza NE, Schofield KL, Arcuri AS, Bulcão RP (2015) Nanotoxicology and exposure in the occupational setting. Occup Dis Environ Med 3(03):35

    Article  Google Scholar 

  3. Howard J, Murashov V (2009) National nanotechnology partnership to protect workers. J Nanopart Res 11(7):1673–1683

    Article  Google Scholar 

  4. Karim ME Munir AB (2015) Nanotechnology: sketching the next big thing in Malaysian context. Nanotechnol Law Bus 12(2):161–172

  5. NanoMalaysia (2014) National Graphene Action Plan 2020. NanoMalaysia Berhad & Agensi Inovasi Malaysia, Kuala Lumpur

    Google Scholar 

  6. StatNano (2019) Nanotechnology patents of 2018 at the USPTO and EPO through the lens of statistics. https://statnano.com/news/65159. Accessed 19 Jan 2019

  7. StatNano (2019) Nanotechnology publications of 2018: an overview. https://statnano.com/news/65056. Accessed 17 Jan 2019

  8. Thompson DK (2011) Small size, big dilemma: the challenge of regulating nanotechnology. Tenn Law Rev 79:621

    Google Scholar 

  9. Snir R (2014) Trends in global nanotechnology regulation: the public-private interplay. Vand J Ent Tech L 17:107

    Google Scholar 

  10. Abbott KW, Marchant GE, Corley EA (2012) Soft law oversight mechanisms for nanotechnology. Jurimetrics:279–312

  11. Thierer AD, Hagemann R, Skees J (2018) Soft law for hard problems: the governance of emerging technologies in an uncertain future. Colorado Technology Law Journal 17(1):37–130

    Google Scholar 

  12. Hodge GA, Bowman DM, Maynard AD (2010) International handbook on regulating nanotechnologies. Edward Elgar Publishing Ltd., Cheltenham

  13. Del Castillo AMP (2013) Nanomaterials and workplace health and safety: what are the issues for workers? European Trade Union Institute, Brussels

    Google Scholar 

  14. Savolainen K, Backman U, Brouwer D, Fadeel B, Fernandes T, Kuhlbusch T, Landsiedel R, Lynch I, Pylkkänen L (2013) Nanosafety in Europe 2015–2025: towards safe and sustainable nanomaterials and nanotechnology innovations. Finnish Institute of Occupational Health, Helsinki

  15. Buzea C, Pacheco I (2018) Toxicity of nanoparticles. In: Pacheco-Torgal F, Diamanti MV, Nazari A, Granqvist CG (eds) Nanotechnology in ecoefficient construction, 2nd edn. Woodhead Publishing, Cambridge, pp 705–754

    Google Scholar 

  16. Oberdörster G, Maynard A, Donaldson K, Castranova V, Fitzpatrick J, Ausman K, Carter J, Karn B, Kreyling W, Lai D (2005) Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy. Part Fibre Toxicol 2(1):8

    Article  Google Scholar 

  17. Schulte P, Geraci C, Murashov V, Kuempel E, Zumwalde R, Castranova V, Hoover M, Hodson L, Martinez K (2014) Occupational safety and health criteria for responsible development of nanotechnology. J Nanopart Res 16(1):1–17

    Article  Google Scholar 

  18. NIOSH (2013) Occupational esposure to carbon nanotubes and nanofibres. Current intelligence Bulletin 65. DHHS (NIOSH) Publication No. 2013-145. https://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf. Accessed 20 Nov 2019

  19. International Labour Organization (2008) Seoul Declaration on Safety and Health at Work. Meeting document, (29 June 2008). Seoul, Republic of Korea. https://www.ilo.org/safework/info/promo/WCMS_151736/lang--en/index.htm. Accessed 15 Jan 2019

  20. Aitken RJ, Peters SA, Jones AD, Stone V (2010) Regulation of carbon nanotubes and other high aspect ratio nanoparticles: approaching this challenge from the perspective of asbestos. Int Handb Regul Nanotechnol:205–237

  21. Thye LL (2014) Need for risk governance. In: The Star Malaysia (23 Oct 2014). https://www.pressreader.com/malaysia/the-starmalaysia/20141023/281938836175839. Accessed 10 Jan 2019

  22. Falkner R, Breggin L, Jaspers N, Pendergrass J, Porter R (2010) International coordination and cooperation: the next agenda in nanomaterials regulation. In: Hodge GA, Bowman DM, Maynard AD (eds) International handbook on regulating nanotechnologies. Edward Elgar, Cheltenham, pp 508–524

    Google Scholar 

  23. Johnson VR (2016) Nanotechnology, environmental risks, and regulatory options. Penn State Law Rev 121:471

    Google Scholar 

  24. McAlea EM, Mullins M, Murphy F, Tofail SA, Carroll AG (2016) Engineered nanomaterials: risk perception, regulation and insurance. J Risk Res 19(4):444–460

    Article  Google Scholar 

  25. Brownsword R (2010) The age of regulatory governance and nanotechnologies. In: Hodge GA, Bowman DM, Maynard AD (eds) International handbook on regulating nanotechnologies. Edward Elgar, Cheltenham, pp 60–83

    Google Scholar 

  26. Klinke A, Renn O (2002) A new approach to risk evaluation and management: risk-based, precaution-based, and discourse-based strategies. Risk Anal 22(6):1071–1094

    Article  Google Scholar 

  27. Renn O (2008) Risk governance: coping with uncertainty in a complex world. Taylor & Francis, London

    Book  Google Scholar 

  28. Marchant GE, Wallach W (2015) Coordinating technology governance. Issues Sci Technol 31(4):43

    Google Scholar 

  29. Breggin LK, Carothers L (2006) Governing uncertainty: the nanotechnology environmental, health, and safety challenge. Colum J Envtl L 31:285

    Google Scholar 

  30. Marchant GE, Allenby B (2017) Soft law: new tools for governing emerging technologies. Bull At Sci 73(2):108–114

    Article  Google Scholar 

  31. Arnaldi S (2017) Changing me softly: making sense of soft regulation and compliance in the Italian nanotechnology sector. NanoEthics 11(1):3–16

    Article  Google Scholar 

  32. Abbott KW (2013) Introduction: the challenges of oversight for emerging technologies. In: Marchant GE, Abbott KW, Allenby B (eds) Innovative governance models for emerging technologies. Edward Elgar, Cheltenham, pp 1–16

    Google Scholar 

  33. Organization for Economic Cooperation and Development (2013) International regulatory co-operation: addressing global challenges. OECD Publishing Paris

  34. Bowman DM, Hodge GA (2008) ‘Governing’ nanotechnology without government? Sci Public Policy 35(7):475–487

    Article  Google Scholar 

  35. Fiorino DJ (2010) Voluntary initiatives, regulation and nanotechnology oversight: charting a path. Project on emerging nanotechnologies Pen-19. Woodrow Wilson International Center for Scholars. https://www.nanotechproject.org/process/assets/files/8347/pen-19.pdf. Accessed 4 Jan 2019

  36. Abbott K, Marchant G, Sylvester D (2009) Transnational regulation of nanotechnology: reality or romanticism? In: Hodge GA, Bowman DM, Maynard AD (eds) International handbook on regulating nanotechnologies. Edward Elgar, Cheltenham, pp 525–545

    Google Scholar 

  37. Marchant GE (2014) ‘Soft law’ mechanisms for nanotechnology: liability and insurance drivers. J Risk Res 17(6):709–719

    Article  Google Scholar 

  38. Hoffman SD, Hoffman ME (1980) Use of standards in products liability litigation. Drake Law Rev 30:283

    Google Scholar 

  39. Wernette R (2010) 8 steps to reducing nanotorts in your nanofuture. LAW360. https://www.law360.com/articles/178122/8-steps-to-reducing-nanotortsin-your-nanofuture. Accessed 18 Nov 2019

  40. Koivisto I (2016) The IMF and the transparency turn. Minn J Int'l L 25:381

    Google Scholar 

  41. Meili C, Widmer M (2010) Voluntary measures in nanotechnology risk governance: the difficulty of holding the wolf by the ears. Int Handb Regul Nanotechnol 446:447–149

    Google Scholar 

  42. Department of Occupational Safety and Health (2005) Guidelines on occupational health services. Ministry of Human Resources Malaysia

  43. Hassan KH, Ab Rahman R (2014) Undang-undang keselamatan industri di Malaysia, 2nd edn. Dewan Bahasa dan Pustaka, Kuala Lumpur

    Google Scholar 

  44. Department of Occupational Safety and Health (2014) Industry code of practice on chemicals classification and hazard communication. Ministry of Human Resources Malaysia

  45. Turley A (2019) Results of GHS for nanomaterials project expected this year. Chemical Risk Manager (25 March 2019). https://chemicalwatch.com/crmhub/75364/results-of-ghs-for-nanomaterials-project-expected-this-year. Accessed 25 Nov 2019

  46. Hamzah Z (2005) Biotechnology law & Strategy. Malayan Law Journal, Lexis Nexis

    Google Scholar 

  47. Department of Occupational Safety and Health (2018) Guideline on control and safe handling of nanomaterials. Ministry of Human Resources Malaysia

  48. Fund ED DuPont-Safer Nanotech. http://business.edf.org/projects/featured/past-projects/dupont-safer-nanotech. Accessed 15 Feb 2019

  49. SÜD TV CENARIOS Certifiable Nanospecific Risk Management and Monitoring. http://innovationsgesellschaft.ch/wp-content/uploads/2015/01/CENARIOS_Factsheet_englisch_2015.pdf. Accessed 15 Feb 2019

  50. Read SA, Kass GS, Sutcliffe HR, Hankin SM (2016) Foresight study on the risk governance of new technologies: the case of nanotechnology. Risk Anal 36(5):1006–1024

    Article  Google Scholar 

  51. European Commission (2009) Commission recommendation on a code of conduct for responsible nanosciences and nanotechnologies research & Council conclusions on responsible nanosciences and nanotechnologies research. Directorate-General for Research Science, Economy and Society, Luxembourg

  52. Safe Nano, Responsible NanoCode. https://www.safenano.org/knowledgebase/guidance/codesofconduct/responsible-nanocode/. Accessed 6 Jan 2019

  53. Safe Nano, Current codes of practice/Conduct for working with nanotechnologies. https://www.safenano.org/knowledgebase/guidance/codesofconduct/. Accessed 6 Jan 2019

  54. BASF Code of Conduct. https://www.basf.com/global/en/who-we-are/sustainability/responsible-partnering/nanotechnology/safety/code-of-conduct.html. Accessed 6 Jan 2019

  55. Murashov V, Howard J (2008) The US must help set international standards for nanotechnology. Nat Nanotechnol 3(11):635–636. https://doi.org/10.1038/nnano.2008.323

    Article  Google Scholar 

  56. Murashov V, Schulte P, Geraci C, Howard J (2011) Regulatory approaches to worker protection in nanotechnology industry in the USA and European Union. Ind Health 49(3):280–296

    Article  Google Scholar 

  57. Finger SR, Gamper-Rabindran S (2012) Protecting workers from adverse chemical exposure: do voluntary standards reduce exposure?

  58. Bell C, Marrapese M (2011) Nanotechnology standards and international legal considerations. In: Murashov V, Howard J (eds) Nanotechnology standards. Springer, New York, pp 239–255

    Chapter  Google Scholar 

  59. World Health Organization (2017) WHO guidelines on protecting workers from potential risks of manufactured nanomaterials. World Health Organization, Geneva

  60. Organization for Economic Cooperation and Development, Publications in the Series on the Safety of Manufactured Nanomaterials. http://www.oecd.org/science/nanosafety/publications-series-safety-manufactured-nanomaterials.htm. Accessed 17 Jan 2019

  61. Organization for Economic Cooperation and Development (2013) OECD countries address the safety of manufactured nanomaterials. http://www.oecd.org/chemicalsafety/oecd-countries-address-the-safety-of-manufactured-nanomaterials.htm. Accessed 17 Jan 2019

  62. Organization for Economic Cooperation and Development, Report of the scientific conference: science based support for regulation of manufactured nanomaterials. http://www.oecd.org/science/nanosafety/prosafe-conference-regulation-of-manufactured-nanomaterials.pdf. Accessed 17 January 2019

  63. Organization for Economic Cooperation and Development, Non-OECD member countries adhering to the OECD system for mutual acceptance of chemical safety data. http://www.oecd.org/chemicalsafety/testing/non-member-adherens-to-oecd-system-for-mutual-acceptance-of-chemical-safety-data.htm. Accessed 17 Jan 2019

  64. International Organization for Standardization, ISO/TC 229 Nanotechnologies. https://www.iso.org/committee/381983.html. Accessed 14 Jan 2019

  65. StatNano, Standards List. https://statnano.com/standards/search?keyword=&country%5B%5D=135. Accessed 18 Jan 2019

  66. Boccuni F, Gagliardi D, Ferrante R, Rondinone BM, Iavicoli S (2017) Measurement techniques of exposure to nanomaterials in the workplace for low-and medium-income countries: a systematic review. Int J Hyg Environ Health 220(7):1089–1097

    Article  Google Scholar 

  67. Armitage A, Cordova AK, Rebecca S (2017) Design-thinking: the answer to the impasse between innovation and regulation. Geo L Tech Rev 2(3)

  68. Dorbeck-Jung B, Shelley-Egan C (2013) Meta-regulation and nanotechnologies: the challenge of responsibilisation within the European Commission’s code of conduct for responsible nanosciences and nanotechnologies research. Nanoethics 7(1):55–68

    Article  Google Scholar 

  69. Department of Occupational Safety and Health (2016) Occupational safety and health master plan 2016-2020. Ministry of Human Resources Malaysia

Download references

Author information

Authors and Affiliations

  1. Ministry of Energy, Science, Technology, Environment and Climate Change Malaysia, Putrajaya, Malaysia

    Halila Faiza Zainal Abidin

  2. Faculty of Law, Universiti Kebangsaan Malaysia, Bangi, Selangor, Malaysia

    Kamal Halili Hassan & Zinatul Ashiqin Zainol

Authors
  1. Halila Faiza Zainal Abidin
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kamal Halili Hassan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Zinatul Ashiqin Zainol
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Zinatul Ashiqin Zainol.

Ethics declarations

Conflict of Interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zainal Abidin, H.F., Hassan, K.H. & Zainol, Z.A. Regulating Risk of Nanomaterials for Workers through Soft Law Approach. Nanoethics 14, 155–167 (2020). https://doi.org/10.1007/s11569-020-00363-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11569-020-00363-7

Keywords

Search

Navigation