Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

Harthorn BH (2013) Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies . PLoS ONE 8(11): e80250. doi:10.1371/journal.pone.0080250 Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies Christian E. H. Beaudrie 0 Terre Satterfield 0 Milind Kandlikar 0 Barbara H. Harthorn 0 Stephen J. Johnson, University of Kansas, United States of America 0 1 Institute for Resources, Environment and Sustainability, University of British Columbia , Vancouver, British Columbia , Canada , 2 Liu Institute for Global Issues, University of British Columbia , Vancouver, British Columbia , Canada , 3 National Science Foundation Center for Nanotechnology in Society, University of California , Santa Barbara, Santa Barbara, California , United States of America The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies' ability to oversee their growing use and application in society. - Funding: This work was supported by Coop. Agreement DBI-0830117 from the U.S. National Science Foundation (NSF) and the U.S. Environmental Protection Agency (EPA) to the University of California Center for Environmental Implications of Nano-Technology; and by Coop. Agreements SES 0531184 and SES 0938099 from the NSF to the Center for Nanotechnology in Society at the University of California, Santa Barbara. Any opinions, findings, and conclusions or recommendations expressed in the material are those of the authors and do not necessarily reflect the views of the NSF or the EPA. This work has not been subjected to EPA review and no official endorsement should be inferred. The authors also thank the Natural Sciences and Engineering Research Council of Canada (NSERC) for their generous support through an Alexander Graham Bell Canada Graduate Scholarship (CGS). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. The degree to which scientists, engineers and regulators are prepared for managing the risks of nanomaterials and their derived products is an open question as empirical knowledge of nanoscale materials and their behaviours is emerging at a slow pace [1]. Significant scientific uncertainties related to both the toxicity and exposure characteristics of these materials remain [2]. In the interim, strategies for the regulation of nanomaterials are necessarily emerging through reference to expert, policy and legal advice. How well this is working is, however, largely unknown. This paper thus examines the perceived state of regulatory and agency preparedness from the point of view of key experts. One early expert study indicated that, overall, nano-experts are more worried about the risks of engineered nanomaterials than are lay or public groups [1,3]. Other work suggests an optimism bias amongst those who develop nano materials and products as compared to those who study or manage their risks [4,5]. Finally, surveys of industry leaders indicate high levels of perceived uncertainty and risk [6], however much they report not following risk-avoidant health and safety practices [7] . Studies of expert opinion in earlier and often more controversial risk domains include expert evaluations of chemical risks [8-11], climate change detection and impacts [12-14],expert views on genetically modified organisms (GMOs) [15,16], and expert perception of ecological risks [17,18]. Differences of opinion have been found to vary according to disciplinary fields [10,16] and/or institutional affiliation (e.g., toxicologists in industry versus academia) [9,19]. Expert opinion has also been found to vary significantly with political attitudes and values. Several scholars have found that similar to non-experts, scientists often use norms or values when making judgments about risk under high uncertainty [10,20-22]. For instance, economically conservative nanoscientists were found by Corley et al. to show less support for regulation [22]. Similarly, trust (in scientists and/or government) has been found to correlate closely with risk perceptions, with attenuation in perceived risk accompanying higher levels of trust [23,24]. Prominent examples of this effect have also been demonstrated in studies of perceived risk of chemicals and GMOs [15,25]. The effect of attributed stakeholder responsibility, that is, the degree of responsibility assigned to different stakeholders to mitigate or manage risk, has received relatively less attention in the nanotechnology domain. Yet a growing body of literature in public health fields suggests a link between attributions of responsibility and support for government and regulatory policy [26-29]. More specifically, nanotechnology researchers have demonstrated differences in perceived need [30] and support [22] for the oversight of nanotechnologies, which has been explained in reference to experts disciplinary degree (i.e. chemistry, physics, materials science, engineering, biology, or other) within the NSE (nano science and engineering) professional body only. Disparity of opinion on risk was also attributed to an observed optimism bias of NSE researchers, compared to NEHS (nano environment, health, and safety) scientists (e.g. toxicologists) [31]. Powell [32] also found significant differences in opinion regarding the novelty and risks of nanomaterials between upstream and downstream researchers; that is, experts involved in the creation of nanotechnologies, versus those engaged in evaluating the health and environmental implications of ENMs. Yet, nanomaterial novelty remains a relatively untested driver of ex (...truncated)