journal article·2011-04

Horses for courses: risk information and decision making in the regulation of nanomaterials

Christian E. H. Beaudrie, Milind Kandlikar

Journal of Nanoparticle Research· Volume 13· Issue 4
Publisher page

Abstract

Despite the widespread commercial use of nanomaterials, regulators currently have a limited ability to characterize and manage risks. There is a paucity of data available on the current production and use of nanomaterials and extreme scientific uncertainty on most aspects of the risk assessment “causal chain.” Regulatory decisions will need to be made in the near-term in the absence formal quantitative risk assessments. The article draws on examples from three different regulatory contexts—baseline data monitoring efforts of the U.S. Environmental Protection Agency and California Department of Toxic Substances Control, prioritization of risk information in the context of environmental releases, and mitigation of occupational risks—to argue for the use of decision-analytic tools in lieu of formal risk assessment to help regulatory bodies. We advocate a “horses for courses” approach whereby existing analytical tools (such as risk ranking, multi-criteria decision analysis, and “control banding” approaches) might be adapted to regulators’ goals in particular decision contexts. While efforts to build new and modify existing tools are underway, they need greater support from funding and regulatory agencies because innovative approaches are needed for the “extreme” uncertainty problems that nanomaterials pose.
Source: openaire · Quality: candidate unverified · Source record ↗

Research context

OpenAlex topics: Nanoparticles: synthesis and applications · Environmental Justice and Health Disparities

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

References (68)

Show source-provided references
1. Beaudrie C (2010) Emerging nanotechnologies and life-cycle regulation: an investigation of federal regulatory oversight from nanomaterial production to end of life. Chemical Heritage Foundation. http://www.chemheritage.org/Downloads/Publications/White-Papers/Studies-in-Sustainability_Beaudrie.pdf
2. Benn T, Westerhoff P (2008) Nanoparticle silver released into water from commercially available sock fabrics. Environ Sci Technol 42:4133–413910.1021/es7032718 ↗
3. Bergeson L, Campbell L, Rothenberg L (2000) TSCA and the future of chemical regulation. EPA Admin Law Report 15:23
4. Berube D, Searson E, Morton T, Cummings C (2010) Project on emerging nanotechnologies—consumer product inventory evaluated. Nanotechnol Law Bus 7:152–163
5. Breggin L, Pendergrass J (2007) Where does the nano go? End-of-life regulation of nanotechnologies. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington, DC
6. Breggin L, Falkner R, Jaspers N, Pendergrass J, Porter R (2009) Securing the promise of nanotechnologies: towards transatlantic regulatory cooperation. LSE and Chatham House. Royal Institute of International Affairs, London
7. Brown S (2009) The new deficit model. Nat Nanotechnol 4:609–61110.1038/nnano.2009.278 ↗
8. Chatterjee R (2008) The continuing uncertainty of nano risks and regulations. Environ Sci Technol 42:773310.1021/es802396x ↗
9. Choi J, Ramachandran G (2009) Review of the OSHA framework for oversight of occupational environments. J Law Med Ethics 37:633–65010.1111/j.1748-720X.2009.00437.x ↗
10. Choi J, Ramachandran G, Kandlikar M (2009) The impact of toxicity testing costs on nanomaterial regulation. Environ Sci Technol 43:3030–303410.1021/es802388s ↗
11. Colvin V (2003) The potential environmental impact of engineered nanomaterials. Nat Biotechnol 21:1166–117010.1038/nbt875 ↗
12. Cooke R (2010) Conundrums with uncertainty factors. Risk Anal 30:330–33910.1111/j.1539-6924.2009.01336.x ↗
13. Cooke R, Probst K (2006) Highlights of the expert judgment policy symposium and technical workshop. Resources for the Future, Washington, DC
14. Davies J (2006) Managing the effects of nanotechnology. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington, DC
15. Engeman C, Baumgartner L et al (2010) Reported practices and perceived risks related to health, safety and environmental stewardship in nanomaterials industries. In: International Sociological Association Conference, Gothenburg, Sweden, 12 July 2010
16. Environment Canada (2007) Proposed regulatory framework for nanomaterials under the Canadian Environmental Protection Act, 1999. http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=FD117B60-1 . Accessed 4 Sept 2010
17. Environmental Protection Agency (EPA) (2009) Nanoscale material Stewardship Program Interim Report. http://www.epa.gov/opptintr/nano/nmsp-interim-report-final.pdf . Accessed 4 Sept 2010
18. Fauss E, Gorman M, Swami N (2009) Using expert elicitation to prioritize resource allocation for risk identification for nanosilver. J Law Med Ethics 37:770–78010.1111/j.1748-720X.2009.00447.x ↗
19. Felcher E (2008) The consumer product safety commission and nanotechnology. Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies Washington, DC
20. Grieger K, Baun A, Owen R (2010) Redefining risk research priorities for nanomaterials. J Nanopart Res 12:383–39210.1007/s11051-009-9829-1 ↗
21. Hansen B, van Haelst A, van Leeuwen K, van der Zandt P (1999) Priority setting for existing chemicals: European Union risk ranking method. Environ Toxicol Chem 18:772–77910.1002/etc.5620180425 ↗
22. Hansen S, Michelson E, Kamper A, Borling P, Steur-Lauridsen F, Baun A (2008) Categorization framework to aid exposure assessment of nanomaterials in consumer products. Ecotoxicology 17:438–44710.1007/s10646-008-0210-4 ↗
23. Heckerman D, Mamdani A, Wellman M (1995) Real-world applications of Bayesian networks. Commun ACM 38:26
24. Helland A, Scheringer M, Siegrist M, Kastenholz H, Wiek A, Scholz R (2008) Risk assessment of engineered nanomaterials: a survey of industrial approaches. Environ Sci Technol 42:640–64610.1021/es062807i ↗
25. International Risk Governance Council (IRGC) (2007) Nanotechnology risk governance: recommendations for a global, coordinated approach to the governance of potential risks. http://www.irgc.org/IMG/pdf/PB_nanoFINAL2_2_.pdf . Accessed 4 Sept 2010
26. International Risk Governance Council (IRGC) (2009) Appropriate risk governance strategies for nanotechnology applications in food and cosmetics. http://www.irgc.org/IMG/pdf/IRGC_PBnanofood_WEB.pdf . Accessed 4 Sept 2010
27. Johnson D, Methner M, Kennedy AJ, Steevens JA (2010) Potential for occupational exposure to engineered carbon-based nanomaterials in environmental laboratory studies. Environ Health Perspect 118(1):4910.1289/ehp.0901076 ↗
28. Kandlikar M, Ramachandran G, Maynard A, Murdock B, Toscano W (2007) Health risk assessment for nanoparticles: a case for using expert judgment. J Nanopart Res 9:137–15610.1007/s11051-006-9154-x ↗
29. Kiker G, Bridges T, Varghese A, Seager P, Linkov I (2005) Application of multicriteria decision analysis in environmental decision making. Integr Environ Assess Manag 1:95–10810.1897/IEAM_2004a-015.1 ↗
30. Knol A, Slottje P, van der Sluijs J, Lebret E (2010) The use of expert elicitation in environmental health impact assessment: a seven step procedure. Environ Health 9:1910.1186/1476-069X-9-19 ↗
31. Kuempel E, Geraci C, Schulte P (2007) Risk assessment approaches and research needs for nanomaterials: an examination of data and information from current studies. Nanotechnol Toxicol Iss Environ Saf:119-14510.1007/978-1-4020-6076-2_8 ↗
32. Kuzma J, Paradise J, Ramachandran G, Kim J, Kokotovich A, Wolf S (2008) An integrated approach to oversight assessment for emerging technologies. Risk Anal 28:1197–122010.1111/j.1539-6924.2008.01086.x ↗
33. Linkov I, Satterstrom F (2009) Nanomaterial risk assessment and risk management. Real-Time Delib Dec Making 2:129–15710.1007/978-1-4020-9026-4_8 ↗
34. Linkov I, Satterstrom F, Steevens J, Fergusen E, Pleus R (2007) Multi-criteria decision analysis and environmental risk assessment for nanomaterials. J Nanopart Res 9:543–55410.1007/s11051-007-9211-0 ↗
35. Linkov I, Satterstrom F, Monica J Jr, Hansen S, Davis T (2009a) Nano risk governance: current developments and future perspectives. Nanotechnol Law Bus 6:203–220
36. Linkov I, Steevens J, Adlakha-Hutcheon G, Bennett E, Chappell M, Colvin V, Davis JM, Davis T, Elder A, Hansen S (2009b) Emerging methods and tools for environmental risk assessment, decision-making, and policy for nanomaterials: summary of NATO Advanced Research Workshop. J Nanopart Res 11:513–52710.1007/s11051-008-9514-9 ↗
37. Lockard S (2010) National leaders sound off on emerging nanotechnology regulation. http://www.plantservices.com/articles/2010/06NanotechnologyRegulation.html?page=full . Accessed 4 Sept 2010
38. Marchant G, Sylvester D, Abbott K (2008) Risk management principles for nanotechnology. Nanoethics 2:43–6010.1007/s11569-008-0028-9 ↗
39. Maynard A (2007) Nanotechnology: the next big thing, or much ado about nothing? Ann Occup Hyg 5:110.1080/15459620701732355 ↗
40. Mittal A (2010) GAO-10-549 nanotechnology: nanomaterials are widely used in commerce, but EPA faces challenges in regulating risk. United States Government Accountability Office. http://www.gao.gov/products/GAO-10-549
41. Morgan K (2005) Development of a preliminary framework for informing the risk analysis and risk management of nanoparticles. Risk Anal 25:1621–163510.1111/j.1539-6924.2005.00681.x ↗
42. Morgan M, Henrion M (1990) Uncertainty: a guide to dealing with uncertainty in quantitative risk and policy analysis. Cambridge University Press, New York10.1017/CBO9780511840609 ↗
43. Nanowerk (2010) Nanowerk nanomaterial database. http://www.nanowerk.com/phpscripts/n_dbsearch.php . Accessed 4 Sept 2010
44. Occupational Health & Safety (2010) Australia considers control banding for nanomaterials. http://ohsonline.com/articles/2010/08/05/australia-considers-control-banding-for-nanomaterials.aspx . Accessed 4 Sept 2010
45. Owen R, Handy R (2007) Viewpoint: formulating the problems for environmental risk assessment of nanomaterials. Environ Sci Technol 41:5582–558810.1021/es072598h ↗
46. Owen R, Crane M, Grieger K, Handy R, Linkhov I, Depledge M (2009) Strategic approaches for the management of environmental risk uncertainties posed by nanomaterials. Nanomat Risks Ben 5:369–38410.1007/978-1-4020-9491-0_29 ↗
47. Owens J (1997) Life-cycle assessment in relation to risk assessment: an evolving perspective. Risk Anal 17:359–36510.1111/j.1539-6924.1997.tb00874.x ↗
48. Paik S, Zalk D, Swuste P (2008) Application of a pilot control banding tool for risk level assessment and control of nanoparticle exposures. Ann Occup Hyg 52:41910.1093/annhyg/men041 ↗
49. Pearl J (1986) Fusion, propagation, and structuring in belief networks. Artif Intell 29:241–28810.1016/0004-3702(86)90072-X ↗
50. Powell M, Griffin M, Tai S (2008) Bottom-up risk regulation? How nanotechnology risk knowledge gaps challenge federal and state environmental agencies. Environ Manage 42:426–44310.1007/s00267-008-9129-z ↗
51. Project on Emerging Nanotechnologies (PEN) (2010) An inventory of nanotechnology-based consumer products currently on the market. http://www.nanotechproject.org/inventories/consumer . Accessed 5 Sept 2010
52. Ramachandran G (2001) Retrospective exposure assessment using Bayesian methods. Ann Occup Hyg 45:65110.1093/annhyg/45.8.651 ↗
53. Ramachandran G, Banerjee S, Vincent J (2003) Expert judgment and occupational hygiene: application to aerosol speciation in the nickel primary production industry. Ann Occup Hyg 47:46110.1093/annhyg/meg066 ↗
54. Robichaud C, Tanzil D, Weilenmann U, Wiesner M (2005) Relative risk analysis of several manufactured nanomaterials: an insurance industry context. Environ Sci Technol 39:8985–899410.1021/es0506509 ↗
55. Seager T, Linkov I (2008) Coupling multicriteria decision analysis and life cycle assessment for nanomaterials. J Ind Ecol 12:1530–9290.200810.1111/j.1530-9290.2008.00048.x ↗
56. Shatkin J (2008) Informing environmental decision making by combining life cycle assessment and risk analysis. J Ind Ecol 12:1530–9290.200810.1111/j.1530-9290.2008.00031.x ↗
57. Sweet L, Strohm B (2006) Nanotechnology life-cycle risk management. Hum Ecol Risk Assess Int J 12:528–55110.1080/10807030600561691 ↗
58. Tervonen T, Lahdelma R (2007) Implementing stochastic multicriteria acceptability analysis. Eur J Oper Res 178:500–51310.1016/j.ejor.2005.12.037 ↗
59. Tervonen T, Linkov I, Figueira J, Steevens J, Chappell M, Merad M (2009) Risk-based classification system of nanomaterials. J Nanopart Res 11:757–76610.1007/s11051-008-9546-1 ↗
60. Tsuji J, Maynard A, Howard P, James J, Lam C, Warheit D, Santamaria A (2006) Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles. Toxicol Sci 89:4210.1093/toxsci/kfi339 ↗
61. Vans O (1998) A belief network approach to optimization and parameter estimation: application to resource and environmental management. Artif Intell 101:135–16310.1016/S0004-3702(98)00010-1 ↗
62. Walker K, Evans J, McIntosh D (2001) Use of expert judgment in exposure assessment. Part I. Characterization of personal exposure to benzene. J Expo Anal Environ Epidemiol 11:308–32210.1038/sj.jea.7500171 ↗
63. Wardak A, Gorman M, Swami N, Deshpande S (2008) Identification of risks in the life cycle of nanotechnology-based products. J Ind Ecol 12:435–44810.1111/j.1530-9290.2008.00029.x ↗
64. Warheit D, Sayes C, Reed K, Swain K (2008) Health effects related to nanoparticle exposures: environmental, health and safety considerations for assessing hazards and risks. Pharmacol Ther 120:35–4210.1016/j.pharmthera.2008.07.001 ↗
65. Weinberg A (1986) Science and its limits: the regulator’s dilemma. Hazards: technology and fairness. National Academy of Engineering, Washington, DC
66. Wong J (2009) Chemical information call-in carbon nanotubes. http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/upload/Formal_AB289_Call_In_Letter_CNTs.pdf
67. Zalk D, Nelson D (2008) History and evolution of control banding: a review. J Occup Environ Hyg 5:330–34610.1080/15459620801997916 ↗
68. Zalk D, Paik S, Swuste P (2009) Evaluating the control banding nanotool: a qualitative risk assessment method for controlling nanoparticle exposures. J Nanopart Res 11:1685–170410.1007/s11051-009-9678-y ↗