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Risk-Based and Prevention-Based Governance for Emerging Materials Timothy Malloy,† Benjamin D. Trump,‡,§ and Igor Linkov*,§ †
UCLA School of Law, Los Angeles, California 90095, United States University of Michigan School of Public Health, Ann Arbor, Michigan 48109, United States § U.S. Army Corps of Engineers − Engineer Research and Development Center, Vicksburg, Mississippi 39180, United States part this is due to the lack of tractable, rigorous and transparent methods for comparative analysis of potentially safer alternatives. We argue that developing decision analytic tools to facilitate and guide risk governance would make preventionbased risk governance practical and achievable. The traditional approach of risk assessment and risk management suffers from several limitations when applied to the governance of emerging materials and technologies. These methodologies were developed in the 1970s and 1980s in order to account for risk in the engineered and well-controlled nuclear and aerospace industries, and subsequently adopted in the environmental and occupational health regulatory regimes under assumption that uncertainty in risk predictions can be quantified and exposure reliably controlled. Such assumptions are challenged within present-day decision scenarios where information regarding potential hazards and exposures are limited such as with the cases of exposure assessment for novel nanomaterial production. Likewise, knowledge about the set of consequences that may result from hazards is often incomplete, where unpredictable effects may emerge from the complex, interconnected interaction of emerging materials in the biological systems and environment. Even probabilistic risk assessment, which is designed to take uncertainty and variability he emergence of new materials and technologies such as into account, is unable to adequately quantify hazard or assess engineered nanomaterials or synthetic biology pose exposure and effects for highly complex and uncertain emerging significant challenges to regulatory bodies.1 Similarly, policythreats.1−3 makers continue to grapple with the regulation of incumbent In contrast to the conventional risk management, preventiontechnologies.2 This exercise is known as risk governance, which based risk governance requires the evaluation of alternative is defined by the International Risk Governance Council as the courses of action against which the regulated system is to be institutions, rules conventions, processes, and mechanisms by compared (Figure 1). Comparative assessment methods need which decisions about risks are taken and implemented.1 For to evaluate the relative performance of alternatives with respect decades, risk governance for chemicals adopted a conventional to the decision-maker’s criteria, such as human health, risk management approach in which risks are quantified in environmental impacts, technical viability, and cost.4,5 absolute units and controlled to acceptable levels. The As illustrated in Figure 1, decision-making in the risk conventional risk management approach can be effective prevention paradigm begins with comparative assessment of the where (i) hazards are well understood, (ii) the set of potential incumbent material or technology and its alternatives across a effects is known, and (iii) exposure can be quantified and range of relevant criteria. In the subsequent evaluation/option reliably controlled. However, where any of these three selection process, the decision-maker uses the results of the conditions are missing, a different approach to risk governance comparative assessment to identify a safer viable alternative and is required in order to facilitate the development of beneficial either require, incentivize, or encourage its adoption. Where materials.3 One potential alternative is prevention-based there are no safer feasible alternatives, or where it leaves governance, which seeks to avoid or minimize hazard, effects, residual risks, prevention is supplemented with more convenand exposure by mandating, directly incentivizing, or tional risk management measures. Because it focuses on encouraging the adoption of inherently safer alternative excising the inherent danger presented by materials or technologies.2,4 technologies, the prevention-based approach minimizes the Although legislators and regulatory agencies have expressed a preference for prevention over control for decades, the notion of prevention has rarely been incorporated into mainstream Received: May 21, 2016 enforceable regulation or governance more broadly. In large ‡
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© XXXX American Chemical Society
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DOI: 10.1021/acs.est.6b02550 Environ. Sci. Technol. XXXX, XXX, XXX−XXX
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Environmental Science & Technology
Figure 1. Methodological comparison of risk and prevention-based governance.
challenges presented by knowledge gaps regarding threats and vulnerabilities and incomplete understanding of the potential consequences.4,5 Prevention-based approaches to regulation are promising, but are in their nascent stages. The notion of prevention-based governance can be traced back to Scandinavia in the mid-20th century, but the actual implementation of the preventive risk governance measures in these countries has been limited. However, preventative regulation found traction in the European Union (2006) and California (2008) for the practice of chemical regulation and policy. In the European Union it became part of REACH, a comprehensive reform of European chemical policy. More recently, EPA has proposed limited use of it in rules relating to chemical facility safety and security. One potential methodological driver of prevention-based governance is multicriteria decision analysis (MCDA), which can support regulators and key governance stakeholders engaged in regulation of emerging materials and technologies.3,5 Specifically, MCDA methods and tools collectively (i) utilize various sources of quantitative and qualitative information to output a quantitative assessment, (ii) comparatively assess novel and conventional technology prototypes that may be used for a presupposed purpose, and (iii) integrate stakeholder views regarding the relative importance of the various decision criteria.3,5 In such deliberations, decision makers are able to account for quantitative information on toxicity and exposure alongside qualitative feedback from subject experts to review whether a proposed novel technology’s risk/benefit trade-off warrants its development over less uncertain and more traditionally utilized options. Overall, the use of prevention-based risk governance is necessary and beneficial for the governance of emerging materials and technologies. Proponents of prevention-based governance will face challenges of justifying multicriteria
evaluations under uncertainty. However, these challenges may be guided by decision analysis, which may offer methodological backing that allows for a transparent comparison of various conventional and novel technologies along with the risks and benefits they pose to humans, animals, and the environment.5 Such an approach would complement traditional risk-based governance for cases of high uncertainty regarding hazards, exposure or the reliability of risk management measures, making it ideal to further the risk governance of various emerging materials and technologies.
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AUTHOR INFORMATION
Corresponding Author
*E-mail:
[email protected]. Notes
The authors declare no competing financial interest.
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ACKNOWLEDGMENTS This work was funded in part by the nanotechnology and emerging material risk research Focus Areas of the US Army Engineer Research and Development Center. Publication of this material has been approved by the authority of the Chief of the U.S. Army Corps of Engineers.
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REFERENCES
(1) Renn, O.; Roco, M. C. Nanotechnology and the need for risk governance. J. Nanopart. Res. 2006, 8 (2), 153−191. (2) Malloy, T. F. Of storms and NatMats: regulatory adaptation in a changing environment. UCLA J. Envtl. L. and Pol’y. 2008, 26, 93−127. (3) Linkov, I.; Satterstrom, F. C.; Monica, J. C.; Foss, S.; Davis, T. A. Nano risk governance: current developments and future perspectives. Nanotechnol. L. & Bus. 2009, 203−220. (4) Malloy, T. F. Design for regulation: integrating sustainable production into mainstream regulation. In Law and the Transition to
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DOI: 10.1021/acs.est.6b02550 Environ. Sci. Technol. XXXX, XXX, XXX−XXX
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Environmental Science & Technology Business Sustainability; Cahoy, D. R., Colburn, J. E., Eds.; Springer International Publishing, 2014; pp 1−23. (5) Linkov, I., Moberg, E. Multi-Criteria Decision Analysis: Environmental Applications and Case Studies; CRC Press: Boca Raton, FL, 2011.
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DOI: 10.1021/acs.est.6b02550 Environ. Sci. Technol. XXXX, XXX, XXX−XXX
