Risk Analysis of Nanomaterials: Exposing Nanotechnology's Naked Emperor

Abstract

Risk analysis (encompassing risk assessment, management, and communication) is touted internationally as the most appropriate approach for governing nanomaterials. In this article, we survey existing criticisms of risk assessment as a basis for regulatory decision making on emerging technologies, particularly highlighting its exclusion of key societal dimensions, its epistemological underdetermination, and its lack of democratic accountability. We then review the specific case of nanomaterials and identify six major barriers to the effective operation of both risk assessment and risk management. These include a lack of: nano-specific regulatory requirements, shared definitions, validated and accessible methods for safety testing, available scientific knowledge, reliable information on commercial use, and capacity for exposure mitigation. Finding the knowledge, standards, methods, tools, definitions, capacity, and political commitment all insufficient, we argue that risk analysis is a “naked emperor” for nanomaterial governance. We therefore suggest that additional concepts and approaches are essential for nanomaterials policy and regulation.

Full text

Risk Analysis of Nanomaterials: Exposing
Nanotechnology’s Naked Emperor
Georgia Miller
School of Humanities & Languages, University of New South Wales, Sydney, Australia
Fern Wickson
Society, Ecology and Ethics Department, Genøk Centre for Biosafety, Tromsø, Norway
Abstract
Risk analysis (encompassing risk assessment, management, and communication) is touted internationally
as the most appropriate approach for governing nanomaterials. In this article, we survey existing
criticisms of risk assessment as a basis for regulatory decision making on emerging technologies,
particularly highlighting its exclusion of key societal dimensions, its epistemological underdetermination,
and its lack of democratic accountability. We then review the specific case of nanomaterials and identify
six major barriers to the effective operation of both risk assessment and risk management. These include
a lack of: nano-specific regulatory requirements, shared definitions, validated and accessible methods for
safety testing, available scientific knowledge, reliable information on commercial use, and capacity for
exposure mitigation. Finding the knowledge, standards, methods, tools, definitions, capacity, and
political commitment all insufficient, we argue that risk analysis is a “naked emperor” for nanomaterial
governance. We therefore suggest that additional concepts and approaches are essential for
nanomaterials policy and regulation.
KEY WORDS: nanotechnology, nanotoxicology, uncertainty, risk assessment, regulation, policy
Introduction
Nanotechnology has been pursued internationally as an “enabling technology”
for the new millennium. There are over 60 state-sponsored nanotechnology
research and development programs (Shapira & Wang, 2010). In 2011 it was
estimated that governments had collectively spent US$65 billion in nanotechnol-
ogy research and development, a figure that was predicted to rise to US$100 bil-
lion by 2014 (Cientifica, 2011). Furthermore, it was estimated that the private
sector would invest US$150 billion in nanotechnology by 2015 (Cientifica, 2011).
The substantial investment in nanotechnology development, combined with both
the predictions of nanotechnology-driven transformation of industry and society
(NSTC, 2011), and the environment, health and safety concerns, and uncertain-
ties raised by the novel behavior of nanoscale materials (Oberd€
orster et al., 2005;
RCEP, 2008), have produced a high level of policy interest in this field that is still
described as “emerging.” Yet whereas the “revolutionary” nature of nanotechnol-
ogy is often touted by proponents (e.g., see NSTC, 2011; Roco and Tomellini,
2002; Wolf and Medikonda, 2012), the key decision-aiding tool being proposed
for its regulation remains remarkably familiar—that of “risk analysis.”
Risk analysis (encompassing risk assessment, risk management, and risk commu-
nication), has been a dominant decision-aiding tool for decades. Risk assessment
originated from the finance sector in the 1960s. It was at first regarded as a method
Review of Policy Research, Volume 32, Number 4 (2015) 10.1111/ropr.12129
V
C2015 Policy Studies Organization. All rights reserved.
485
bs_bs_banner

for systematic analysis, rather than a science, although it was increasingly deployed
to demonstrate the objectivity and quantitative precision of assessment processes
(Jasanoff, 2005). In 1983, the U.S. National Research Council recommended that:
“the scientific findings and policy judgments embodied in risk assessments should
be explicitly distinguished from the political, economic, and technical considera-
tions that influence the design and choice of regulatory strategies” (NRC, 1983). Yet
despite attempts to insulate the “scientific” process of risk assessment from the polit-
ical nature of risk management and policy making, there have been repeated dem-
onstrations that risk assessment itself has a normative character that it is subjective,
and that it may perform political work (Jasanoff, 2005).
The deficiencies of relying on risk assessment as a decision-aiding tool have been
most strongly highlighted in fields with both a high potential for social impact, and
a high level of scientific uncertainty—attributes that also characterize the emerging
field of nanotechnology. Yet despite a growing nanotoxicological literature explor-
ing the risks of nanomaterials and unearthing ever more uncertainties and chal-
lenges for the development of appropriate methods (e.g., see Grieger, Hansen, &
Baun, 2009; Grieger, Linkov, Hansen, & Baun, 2012; Savolainen et al., 2010), a pol-
icy literature investigating the extent to which existing frameworks for chemicals
may be legally and practicably suitable for their regulation (e.g., see OECD, 2011,
2013; SCENIHR, 2006), and a social and ethical aspects literature that elucidates
the broader challenges of nanotechnology development (e.g., see Allhoff, Lin, &
Moore, 2010; Kjølberg and Wickson, 2010; van Lente et al., 2012), there has been
very little evaluation and critique of the use of risk analysis per se as the dominant
decision-aiding tool in this new field. This article aims to draw together the science
studies, nanotoxicology, and policy and regulatory literature, to first review the
existing critique of risk analysis as a deficient decision aiding tool for fields with
high social stakes and scientific uncertainty, and second, to specifically evaluate the
barriers and challenges to its application and use in the case of nanotechnology.
The article therefore starts by reviewing the documented deficiencies of risk analy-
sis as a decision-aiding tool for the governance of new and emerging technologies in
general, before turning to specifically focus on reviewing the current capacity for
delivering a reliable scientific assessment of the potential risks to both human health
and the environment of nanomaterials.
The article begins by providing a short introduction to nanotechnology, in
which we specifically explore the unruly nature of the nanoscale and the tension
between proponents’ representations of nanotechnology as a revolutionary plat-
form technology (as often underpins research funding initiatives) and the
product-based framing of regulatory discourse, which focuses on risk assessment
of passive nanomaterials. We characterize the development of nanotechnology as
similar to an emerging empire, in which a new-found geographical space is being
colonized and exploited, and we show how the responsibility to govern and con-
trol this unruly realm is being awarded to the “emperor” of scientific risk assess-
ment. Following this, we review established critiques within the social science
literature of the overarching deficiencies of risk analysis as a dominant decision-
aiding tool, for both science policy and the governance of emerging technologies.
In the remainder of the article, we focus our attention on providing a detailed
review of the emerging nano(eco)toxicology and policy literature to evaluate the
486 Georgia Miller and Fern Wickson

efficacy and operation of risk analysis specifically in relation to nanomaterials.
Through this review, we identify six key technical, practical, political, and eco-
nomic barriers to the effective and reliable performance of risk assessment and
management for nanomaterials. These include a lack of: nano-specific regulatory
requirements, shared definitions, validated and accessible methods for safety test-
ing, available scientific knowledge, reliable information on commercial use, and
capacity for exposure mitigation. Following this finding, we draw an analogy
between this situation and the fable “The Emperor’s New Clothes” by Hans
Christian Andersen. We do this by arguing that despite risk analysis being
granted an emperor-like status for the control and regulation of nanotechnology,
this emperor is effectively naked (both because of the overarching deficiencies of
risk analysis but also because of the specific barriers to performing reliable risk
analysis for nanomaterials) and yet no one appears to be brave enough to admit
that the emperor is not wearing any clothes.
Through the review presented in this article, we therefore argue that even if
one disregards the long-standing and overarching critiques of risk assessment as
a decision-aiding tool in the governance of emerging technologies (i.e., its narrow
focus, epistemological weakness, and lack of democratic accountability), the spe-
cific barriers currently facing the practice of performing risk analysis for nanoma-
terials are so serious that alternative governance concepts, approaches, and tools
need to be further developed and utilized in policy and decision making if the
health and safety of humans and the environment are to be protected. In the
closing sections of this article, we therefore conclude by pointing to some of
the alternative approaches and concepts that are currently available, highlight
important areas for future research, and pose the provocative question of what a
“values-based” as opposed to “science-based” approach to decision making on
nanotechnology development and use may entail.
A Short Introduction to Nanotechnology
Nanotechnology can be regarded as a platform of enabling techniques, rather
than a discipline-specific or material-specific undertaking (Whitman, 2011). In
their influential early analysis of nanotechnology, the Royal Society and Royal
Academy of Engineering (2004, p. viii) defined the field in the following terms:
Nanoscience is the study of phenomena and manipulation of materials at atomic, molecular and
macromolecular scales, where properties differ significantly from those at a larger scale.
Nanotechnologies are the design, characterization, production and application of structures, devices
and systems by controlling shape and size at nanometre scale.
Nanoscience therefore takes place across a wide range of disciplines, including
chemistry, physics, biology, and materials science, while nanotechnologies are
being developed for application across a broad range of sectors, including food,
energy, medicine, computing, transportation, and household goods. The expres-
sion of novel properties at the nanoscale occurs by one of three key mechanisms:
the presence of quantum effects, the increase in surface area to volume ratio,
and/or the potential for alternative molecular structures. Quantum effects are
Risk Analysis of Nanomaterials 487

phenomena manifesting at the atomic level that are not adequately explained by
classical (Newtonian) physics. For example, at the quantum level, matter behaves
as both a wave and a particle and is said to occupy a kind of “superposition” until
observation fixes it as one or the other. An increase in surface area to volume ratio
occurs whenever an object is divided into smaller pieces (that is, more surfaces are
created while the volume stays the same). The incredibly small size of nanoscale
objects means that the majority of atoms or molecules are located on surfaces and
because surfaces represent potential interfaces, this often enhances reactivity.
Novel properties can also arise because atomic configurations can be altered at the
nanoscale. For example, both graphite and diamond are made of carbon atoms
but these materials have very different physical properties because of the way in
which the atoms are arranged (in a sheet form for graphite and in a tetrahedral
shape for diamond). One of the early areas of development in nanotechnology
was the ability to fabricate different atomic structures for carbon, including soccer-
ball-like shapes (fullerenes) and cylindrical tubes (carbon nanotubes). Carbon
nanotubes are both stronger and lighter than steel and can have very high con-
ductivity, a good example of nanomaterials expressing novel properties.
Anticipation of widespread nanotechnology-driven change has led to predic-
tions that nanotechnology will “transform every aspect of our lives” (DITR,
2006), bringing social and economic “disruption” (APEC, 2002). More recently,
the U.S. National Science and Technology Council (NSTC) affirmed the U.S.
National Nanotechnology Initiative vision of “a future in which nanotechnology
benefits society through a revolution in technology and industry” (NSTC, 2011,
p. iv). Indeed the revolutionary potential of as-yet undeveloped forms of nano-
technology has been a central feature of promissory claims mobilized to attract
government funding and political support (McRay, 2013).
There is, however, an interesting tension, between the revolutionary claims
attached to projected future forms of nanotechnology, and the focus of much of
the current research, commercial activity and policy debate. The latter has been
more closely associated with new developments in materials science, or what has
been called “first generation” nanotechnology—the development of passive nano-
structures that possess novel properties emergent at the nanoscale (Roco, 2011).
Manufactured nanomaterials display or directly utilize novel physico-chemical
properties that occur at the nanoscale, including altered reactivity, solubility, con-
ductivity, or appearance. It is these manufactured nanomaterials (rather than the
envisioned complex nanotechnology systems or devices) that are currently widely
used in consumer, industrial, and state-backed applications. Manufactured nano-
materials are currently used in cosmetics and sunscreens, food additives, textile
treatments, paints and surface coatings, sporting equipment, kitchen equipment,
electronics, industrial catalysts, sensors, agricultural pesticides, and many other
products (e.g., see nanodb.dk). It is these applications that have been the focus
of regulatory discourse, particularly for the novel toxicological risks they may
pose to workers, consumers, or environmental systems. Yet the governance chal-
lenges associated with nanotechnology extend beyond questions of product
safety. Like other technosciences (Jasanoff, 2006), nanotechnology offers the
potential to extend political, economic, and/or cultural power. Indeed, we could
characterize the push for nanoscale development as contemporary empire
488 Georgia Miller and Fern Wickson

building, where the nanoscale is a newfound geographical space that is being
conquered and colonized at an increasingly rapid rate.
As an expanding empire, the nano world is an incredibly diverse and unruly
realm, with its unruliness being multi-faceted. Nanomaterials express novel and
typically unpredictable physicochemical and biological properties (Oberd€
orster
et al., 2005; RCEP, 2008), and due to their small size and novel properties pres-
ent unprecedented challenges for measurement, characterization, and exposure
assessment (Chaudhry, Bouwmeester, & Hertel, 2010; Miles, 2010). The unruli-
ness of nanotechnology, however, may also be linked to its claimed potential for
large scale societal and economic transformation or “revolution” (APEC, 2002),
and the shifting range of narratives told concerning it which make its identity
and impacts difficult to pin down (Sparrow, 2010; Wickson, 2008). The gover-
nance needs for this realm are arguably broad, including measures to avoid
calamity, direct development, and gain social license for ongoing expansion. To
grapple with these broad governance needs for the unruly field of nanotechnol-
ogy, soft-law measures such as “codes of conduct” for science and industry self-
regulation have been pursued (e.g., European Commission, 2009a, 2009b;
Insight Investment, Royal Society, Centre for Process Innovation and Nanotech-
nology Industries Assosciation, 2008), as have programs of state-sponsored public
engagement and stakeholder dialogue (e.g., see Grobe, 2010; Stilgoe, 2007), as
well as the development of new governance concepts such as “responsible
research and innovation” (see Jacob et al., 2013; Stilgoe, Owen, & Macnaghten,
2013; van den Hoven et al., 2013). We return to some of these initiatives in the
final section of the article; however, it is important to note that despite this
experimentation with soft governance measures, the scope for law-based regula-
tion with the potential to limit or control the commercial sale of nanomaterials,
nano-devices, or nano-products, or to impose legally binding requirements on
manufacturers or distributors, has been framed narrowly in terms of managing
the safety risks of manufactured nanomaterials that can be empirically confirmed
and quantified. That is, the emperor being given the mandate to control the
diverse and unruly nano empire is scientific risk analysis.
The sociopolitical nature of the expanding nano empire creates a special
responsibility to ensure effective and socially accountable governance of nano-
technology development and use. It also renders the narrow focus of regulatory
discourse on managing the safety risks of first generation nanomaterials problem-
atic. The tendency of proponents to make wide-ranging claims of a technology’s
programmatic economic and social potential in order to secure funding or other
forms of support, while insisting that regulation be limited to a technical assess-
ment of safety risks for individual products, has also been observed in relation to
previous technologies, such as biotechnology (Jasanoff, 1995, 2005). This
“product” framing, and the use of evidence-based assessment of safety risks as
the basis of regulatory decision making, limits decision makers to considering
technical evidence of extant hazards and exposure associated with a particular
application. Furthermore, this limits regulatory consideration to products at the
point of commercialization and isolates regulatory decision making on individual
products from the broader program of development, precluding consideration of
programmatic aims, trajectories, intent, or alternatives. These tendencies may
Risk Analysis of Nanomaterials 489

privilege the epistemologies and judgments of technical experts and externalize
broader societal dimensions from assessment. In this way, a regulatory focus on
risk analysis of nanomaterials as the appropriate site of regulation for nanotechnol-
ogy performs political work, reflecting and re-inscribing, while obscuring, a range
of normative judgments. The second half of this article will focus on evaluating
the performance and reliability of risk analysis of nanomaterials, recognizing that
this forms the basis of regulatory approaches internationally. Nonetheless, we
would like to stress from the outset that there is an a priori problem in the wide-
spread conflation of product-based nanomaterials regulation with a more pro-
grammatic governance of nanotechnology.
Classic Criticisms of Risk Assessment as a Policy Aiding Tool
Significant criticisms have been raised in recent decades regarding reliance on
risk assessment as the dominant decision-aiding tool in the governance of new
and emerging technologies. These criticisms include: granting primacy to risk
assessment as the basis for decision making excludes from consideration impor-
tant normative dimensions, including social values (Davies, Macnaghten, &
Kearnes, 2009; Ferrari, 2009; Levidow, 2007; Wynne, 2001); risk assessment is
epistemologically underdetermined, involving unacknowledged assumptions,
extrapolations, and value judgments (Groves, 2009; Jasanoff, 1990); and expert-
dominated risk assessment fails to be democratically accountable (Morris, 2012;
Stirling, 2008). Below we provide a brief survey of these classic arguments
against the sufficiency of risk analysis as a policy tool and elucidate their rele-
vance for regulatory decision making in relation to nanomaterials.
Risk Assessment Excludes Key Questions of Social Values
The discourse of risk has been said to characterize and dominate late modernity
(Beck, 1992), with significant implications for the framing of debates concerning
new technologies and their regulation. The prevalence of risk discourse reflects
acknowledgement in the science and policy communities that emerging technolo-
gies pose new safety threats to human health and environmental systems. None-
theless, a policy focus on risk assessment as the key basis for decision making
remains “coupled to an optimistic and largely modernist social imaginary”
(Macnaghten & Chilvers, 2012, p. 101). This imaginary sees the development of
science and technology as an axiomatic vehicle for progress, closely tied to future
prosperity. As with earlier technologies, such as nuclear technologies or geneti-
cally modified organisms, the emerging nanotechnology policy dialogue is also
taking place largely within a “risks vs. benefits,” or risk/benefit, frame (Miller &
Scrinis, 2010). This framing suggests that nanotechnology’s development should
be supported and its commercialization promoted, as it will certainly lead to
social, economic, and even environmental benefits, while all “downsides,” or rea-
sons for regulatory intervention, are conceived narrowly in terms of potential
(and therefore less certain) safety threats which can be “domesticated” by the
rational management of quantitative risk assessment (Groves, 2011). The view
490 Georgia Miller and Fern Wickson

that “evidence-based” risk assessment of nanomaterials is the sole legitimate basis
for regulatory decision making on nanotechnology is widely held and apparent
in communications from governments, regulators, businesses, and researchers
internationally (ETIPC, 2011; ICCA, 2010; Maynard, 2006). Scientific risk
assessment is proposed as the basis of nanomaterials regulation in Europe
(European Commission, 2009a, 2009b), the United States (ETIPC, 2011; U.S.
EPA, 2011) and Australia (NICNAS, 2010a); it is also key to nanotechnology gov-
ernance initiatives in China (Jarvis & Richmond, 2011), Thailand, and South
Korea (OECD, 2011).
The emphasis on risk as the basis for regulatory decision making, and the
dominance of the risk/benefit binary is highly problematic. First, as mirrored in
earlier technologies, all societal concerns are channeled into “risk” language. This
sees public concerns, questions, or dissent not based on scientific evidence of
potential physical harm frequently dismissed as uninformed, irrational, or illegiti-
mate (Sylvester, Abbott, & Marchant, 2009). The narrow focus on toxicity risks
excludes from debate key societal dimensions such as efficacy and cost-
effectiveness (Faunce, 2009), military uses (Altmann, 2010), privacy and civil liber-
ties, sustainability (Maclurcan & Radwyl, 2012), equity (Invernizzi, Foladori, &
Maclurcan, 2008), intellectual property (Bowman, 2007), and bioethics (Wolbring,
2008). Second, despite the largely hypothetical nature of both the benefits and
risks from the expanding empire of nanotechnology, the term “risk” implies a
greater level of uncertainty than the confident language of “benefits.” Third, dis-
cordant evidentiary standards are applied to nanotechnology innovation and reg-
ulatory policies, meaning that risks have to be empirically proven to justify
regulatory action, whereas benefits stimulate innovation policy in their hypotheti-
cal form, largely shielded from accountability and debate (Kearnes, Grove-White,
Macnaghten, Wilsdon, & Wynne, 2006; Miller & Scrinis, 2011). Finally, the pro-
duction of scientific knowledge (including activities, assumptions, and decisions
made by researchers), is often left out of political debate and ethical analysis when
a risk/benefit frame is adopted, meaning that the broader political, cultural, and
socioeconomic forces shaping research and development agendas, and their
accompanying sociotechnical imaginaries, are typically not subject to assessment
(Jamison, 2009; Macnaghten, Kearnes, & Wynne, 2005). A risk/benefit framing
therefore reflects and reinforces a technologically optimistic approach in which
generous public funding for nanotechnology research, development, and com-
mercialization activities is taken as a given, whereas the only legitimate justification
for legally enforceable regulation that may slow or shape the nano empire’s expan-
sion is empirical data demonstrating a clear and significant threat to health or
environmental safety.
Risk Assessment is Epistemologically Underdetermined
The privileged role for scientific risk assessment, for nanomaterials regulation
but also in precedent fields such as biotechnology and chemicals regulation, is
based on the premise that scientific knowledge offers a platform for objective
regulatory decision making, free from the influence of particular values, beliefs,
and assumptions (Wickson, Grieger, & Baun, 2010; Wickson & Wynne, 2012).
Risk Analysis of Nanomaterials 491

Because of this, the concepts of “scientific risk assessment” and “evidence-based
decision making” are sometimes used interchangeably. When governments and
scientists emphasize the need for nanotechnology policy to be “evidence-based”
(ETIPC, 2011; Helland, Kastenholtz, Thidell, Arnfalk, & Deppert, 2006), this
implies the need for a threshold of certainty surrounding risk. That is, that regu-
latory intervention must only take place once risk data is assembled and verified,
with “quantitative measures of error, uncertainty and sensitivity” to ensure that
any regulatory intervention is “rational” (Nel et al., 2010). The contingency of
the risk-based knowledge generated—related to uncertainty, ambiguity, igno-
rance, and the role of social processes, and value judgments in shaping risk-
based research—are usually unacknowledged by proponents of risk assessment
(Groves, 2009). Yet risk assessment is always both underdetermined and affected
by normative assumptions and commitments (Jasanoff, 1999; Stirling, 2001;
Wickson & Wynne, 2012).
In an idealized representation, the risk assessment “paradigm” involves hazard
identification and characterization followed by exposure assessment and risk
characterization (EFSA, 2011). Yet in recent decades, the ostensibly objective and
scientific process of risk assessment has been shown to be highly sensitive to con-
ditioning pressures and framing effects. Given the substantive array of decisions
that need to be made to frame and contain an individual assessment (as well as
the science that feeds into it), it is possible for different assessments of a similar
product, while internally logical and consistent, to yield highly variant outcomes
(Stirling, 2005; Wynne, 1996). Actors with different stakes in technical controver-
sies, who bring different kinds of knowledge to bear upon the same problems,
and scientific researchers with different disciplinary backgrounds, who bring dif-
ferent methods and approaches to the same task of generating knowledge on
risks, can all arrive at different outcomes and analyses. Ambiguities in the knowl-
edge base and discrepancies between the outcomes of individual analytic or
appraisal activities are often large enough to support different performance
orderings for the options being considered, which has important implications for
technology choice (Stirling, 2005). A science studies scholar and senior environ-
mental protection professional at the U.S. Environmental Protection Agency Jeff
Morris (2012, p. 52) recently wrote:
... risk assessment is a system so inherently weak and fraught with epistemological underdetermina-
tion that the experts who create risk assessments hold them together with quantitative uncertainty
factors, extrapolations, and modeling assumptions—the methodological equivalents of wire and
duct tape—to such an extent that the construction and characterization of the assessment’s risk
estimate are opaque not only to the public but to the policy makers who must decide how such
assessments inform their decisions.
Uncertainty and knowledge gaps make it “difficult, and often impossible, to
apply routine decision-making procedures for risk assessment and management”
(Falkner & Jaspers, 2012, p. 30). There are clearly methodological problems with
performing quantitative risk assessment on uncertain data. Much risk assessment
relies on probability theory, which seriously undermines its applicability where
there is high uncertainty, indeterminacy, or ignorance (Funtowicz & Ravetz,
1993; Stirling, 2007; Wynne, 1992). The question of (unacknowledged) norma-
tive values and their influence on scientific knowledge and expert judgment
492 Georgia Miller and Fern Wickson

become especially important where uncertainties are substantive because just as
with lay publics, scientists’ personal, and professional circumstances can substan-
tially affect how they assess and perceive risks (Kvakkestad, Gillund, Kjølberg, &
Vatn, 2007; Powell, 2007).
Expert-Dominated Risk Assessment Fails to be Democratically Accountable
A final classic criticism from the social sciences of the reliance on risk assessment
as primary decision-aiding tool for emerging technologies is its lack of democratic
accountability. Science and technology are thoroughly political—they exist within
not outside society, and their development is shaped by societal and economic
factors and the activities of interested actors (Kleinman, 2005). Yet the power to
decide whether or not certain technologies should be commercialized, in what
circumstances, and with what information provided to people who may be
affected, is increasingly arrogated to scientific risk analysis, which is inaccessible
and largely unaccountable to wider publics. Despite the use of risk discourse by
civil society groups and affected communities to argue for public interest man-
agement of technology, the dominance of risk assessment as the basis for decision
making can be seen to privilege expert knowledge and voices in public debates.
Risk can be harnessed to create “expert enclosures” that shield risk analysis and
appraisal from scrutiny by wider publics, and which reflect and reconstitute hier-
archical social relations (Gottweis, 1998). A demand for “evidence-based” risk
assessment by experts can be used for instrumental political purposes, to silence
or marginalize calls for precaution. As contingencies and subjectivities within
expert assessments have been highlighted, especially where substantive scientific
uncertainty exists (for example in relation to genetically engineered crops,
nuclear technologies, and nanotechnology), scholars have increasingly criticized
risk assessment as democratically deficient (Morris, 2012; Pidgeon & Rogers-
Hayden, 2007; Stirling, 2005, 2008; Wynne, 1996).
This brief review of classic social science critiques demonstrates the breadth
and depth of scholarly attention already directed toward the deficiencies of a reli-
ance on risk assessment as the primary decision-aiding tool for the governance of
emerging technologies. However, such criticism appears to have had little impact
on the policy and regulatory responses of governments to nanomaterials, which
continue to advocate regulation based on technical risk analysis (ETIPC, 2011;
European Commission, 2009a, 2009b; NICNAS, 2010a; U.S. EPA, 2011). In this
article, we acknowledge the narrow focus of risk/benefit framing, the epistemo-
logical weakness of risk analysis, and the lack of its public accountability. We also
acknowledge that the regulation of nanomaterials should not be understood as a
sufficient basis for the governance of nanotechnology more broadly. Nonetheless,
in the remainder of the text we wish to primarily focus on performing a critical
appraisal of the existing capacity to perform risk assessment and management
for manufactured nanomaterials, recognizing that this forms the basis of interna-
tional regulatory responses to nanotechnology. That is, we review the current
capacity for delivering a reliable scientific assessment of the potential for nanoma-
terials to cause harm to both human health and the environment, and for the
implementation of actions to mitigate or prevent such harm. Identifying and
Risk Analysis of Nanomaterials 493

describing barriers to effective risk analysis of nanomaterials, we assert that the
knowledge, tools, standards, methods, definitions, and political commitment
required are all insufficient. Drawing an analogy to the popular fable of “The
Emperor’s New Clothes,” we therefore suggest that despite the best hopes of
government, business, researchers, and public interest advocates, the emerging
emperor of the nano empire is naked. Arguing that this creates both concerns
regarding the effectiveness of regulatory decision making on nanomaterials, and
also opportunities for normative values to take a more explicit role in informing
the policy dialogue, we conclude by pointing to some of the alternative concepts,
approaches, and tools that are currently available for aiding and informing deci-
sion making and argue that these should become the subject of further research,
experimentation, and application, and be used to supplement ongoing research
on the risks posed by nanomaterials.
Specific Barriers to Risk Analysis of Nanomaterials
Risk assessment and risk management are predicated on an ability to predict,
measure, and control risks to human and environmental health. Yet despite a
growing “cacophony of information” surrounding environment, health, and safety
impacts of manufactured nanomaterials (Powers et al., 2013), it remains “difficult,
and often impossible” (Falkner & Jaspers, 2012) to apply standardized scientific
criteria and routines for risk-based research and assessment. In what follows, we
will synthesize the existing literature and elucidate the range of reasons why in
relation to nanomaterials the emperor of scientific risk analysis is “naked.”
Inadequate Nano-Specific Regulatory Requirements Mean that Risk Analysis Is Often
Not Performed
Recognizing their novel properties and therefore the potential to pose novel
risks, in 2004 the United Kingdom’s Royal Society and Royal Academy of Engi-
neering recommended that nanoparticles be treated as new chemicals for the
purpose of regulation (RS/RAE, 2004). Despite this, the widespread introduction
of nano-specific “triggers” in regulatory frameworks has not followed; regulatory
systems internationally largely do not distinguish between a nanoscale material
and its chemically identical but morphologically distinct larger-scale counterpart,
even though novel physicochemical properties exist at the nanoscale (Maynard,
Bowman, & Hodge, 2011). This means that in most jurisdictions, for example in
Europe, the United States, and Australia, without a defined trigger for a new
assessment process, and where substances have a history of approved use in bulk
form, many nano-products are sold without the performance of any nano-
specific risk assessment (Bowman & Hodge, 2007; Faunce & Watal, 2010). Fur-
thermore, existing regulatory frameworks incorporate metrics and tonnage
thresholds that may be unsuitable for nanomaterials whose greater potency
means that they are produced and used in much smaller quantities than their
bulk counterparts. For example, although in Europe nanomaterials are in princi-
ple regulated within the REACH chemicals framework, there is no differentiation
494 Georgia Miller and Fern Wickson

between the bulk and nano-forms of a substance (ECHA, n.d.) and the threshold
for requiring registration and therefore risk information for the import or
manufacture of a nanomaterial remains the standard of one tonne (Eisenberger,
Nentwich, Fiedler, Gazso, & Simko, 2010). The lack of nano-specific provisions
in REACH has been critiqued by senior bureaucrats at the German Federal
Environment Agency concerned that it has led to very little information being
provided to the chemicals regulator (Schwirn, Tietjen, & Beer, 2014). For the
second registration period (ending 31 May 2013), only four substances were reg-
istered with ECHA as nanomaterials, and information that was provided lacked
requisite physicochemical characterization (Schwirn et al., 2014). The officials
conclude that “this shows that the obligations regarding nanomaterials are either
not clear enough or the current regulation offers too many loopholes, or both”
(Schwirn et al., 2014, p. 3). This means that despite the rhetoric of control
through scientific risk assessment, for the vast majority of nanomaterials used in
commercial products today, regulatory risk assessment is not legally required and
has in fact never been performed. That is, although there is a discourse of regu-
lation and control through risk assessment to deliver public and environmental
safety, in fact the vast majority of commercial nanotechnology products have
never been required to pass through such an evaluation.
Disagreement Over Definitions Including Relevant Size, Size Distribution,
Intentionality of Production, and Occurrence of Novel Properties
Effective regulation requires that the trigger for nano-specific risk assessment be
well defined, to ensure that assessment of novel nanomaterials takes place. There
is, however, no internationally agreed definition for nanomaterials. This is per-
haps not surprising since in addition to persistent scientific uncertainty surround-
ing the precise relationship between size and novel physicochemical properties of
nanomaterials, any choice of definition will have social and economic implications
(Williams, 2010) and therefore be subject to debate and negotiation amongst dif-
ferent stakeholders. Indeed policy debates surrounding efforts to define nanoma-
terials reflect both physicochemical and sociopolitical considerations and
interests.
The International Organization for Standardization (ISO) has developed a def-
inition of the nanoscale which encompasses both size (approximately 1–100 nm)
and the presence of novel phenomena (ISO 27687). However, while this size-
based threshold has also been used in Europe (European Commission, 2011),
the United States (U.S. EPA, 2015) and Australia (NICNAS, 2010a), among other
countries, it is far from uncontroversial. In its expert opinion delivered to the
European Commission, the Scientific Committee on Emerging and Newly Identi-
fied Health Risks (SCENIHR) cautioned that despite the use of the 100 nm
upper threshold: “There is no scientific evidence to qualify the appropriateness
of this value” (SCENIHR, 2010, p. 6). Leading nanotoxicologists have argued
both that there is no neat cut-off point in nano-specific biological activity
(Donaldson, Stone, Clouter, Renwick, & MacNee, 2001) and that particles around
200 nm in size can pose similar toxicity issues (House of Lords Science and Tech-
nology Committee, 2009). During the process of ISO definitional negotiations,
Risk Analysis of Nanomaterials 495

the former chairman of Australia’s ISO delegation has written of “strong argu-
ments that the [definitional] range should extend higher (300–400 nm)” (Miles,
2010, p. 94). Recognizing that any size-based definition for nanomaterials would
be a crude index of the existence of novel properties, which will vary between
materials, Andrew Maynard has warned that “there is a growing danger of sci-
ence being pushed aside” and urged regulators to not define nanomaterials but
to instead use a list of “nine or ten attributes” as trigger points for regulatory
intervention (Maynard et al., 2011, p. 31). This view has proved controversial.
The European Commission’s Joint Research Centre, for example, has insisted
that size is the most appropriate parameter with which to define nanomaterials,
and that a size-based definition is required for practical implementation of label-
ling and regulatory initiatives (Stamm, 2011). Despite this, some regulators,
including the United States’ Food and Drug Administration and Australia’s Ther-
apeutic Goods Administration, have explicitly elected not to provide any defini-
tion for nanomaterials they regulate.
In addition to the debate over the appropriate numerical dimensions or mate-
rial attributes for defining the nanoscale, controversy has also accompanied work
to define what proportion of a sample material must be in nano form to trigger
nano-specific regulation and risk assessment. Here there is even less agreement
among regulators and policy makers internationally. In Europe, SCENIHR rec-
ommended that the European Commission adopt a threshold of >0.15% by parti-
cle number, including aggregates and agglomerates (SCENIHR, 2010). Yet after
12 months of industry lobbying, with far higher thresholds proposed by the
chemicals industry (e.g., ICCA, 2010), the European Commission adopted a defi-
nition of nanomaterials with a threshold of 50% by particle number, including
agglomerates and aggregates. The definition did make the exception that in spe-
cific cases and “where warranted by concerns for the environment, health, safety
or competitiveness,” the number size distribution threshold may be replaced by
1–50% (European Commission, 2011). The U.S. EPA and the Australian chemical
regulator NICNAS have both used a threshold of threshold of 10% by particle
number (Duvall and Wyatt, 2011; NICNAS, 2010a).
A further contested, albeit less discussed, aspect of defining nanomaterials for
regulatory purposes is the criterion of intentionality. The European Commis-
sion’s definition includes “natural, incidental, or manufactured material contain-
ing particles,” meaning that in theory, all nanomaterials (of the prescribed size
and threshold) will trigger assessment. This could mean that where manufac-
turers are using samples that incidentally or naturally happen to have a wide
particle size distribution that includes >50% nanoparticles, despite not resulting
from any planned or deliberate effort, these samples will still trigger nano-
specific requirements. Conversely, the working definition employed by the Aus-
tralian regulator NICNAS requires that in order to trigger notification and
assessment requirements, nanomaterials must be intentionally manufactured and
included in the product in question (NICNAS, 2010a). That is, the manufacturer
must have had the intention to take advantage of the novel properties of the
nanomaterial, and to have deliberately chosen to include the nanomaterials in
the product, in order for the samples to trigger nano-specific oversight. The
presence or absence of a criterion of intentionality has prompted debate
496 Georgia Miller and Fern Wickson

regarding its practical implications for industries that may have traditionally used
materials with a proportion of particles in the nanoscale (e.g., in dyes, paints or
textile treatments); the potential burden for regulators to perform a new wave of
nano-specific assessments of products that have not typically been regarded as
“nano”; whether intentionality has any relationship with safety; and in a climate
of uncertainty, where the burden of proof should lie.
Without a clear internationally agreed definition that encompasses all nano-
scale materials exhibiting novel properties, it appears likely that many applica-
tions and products will fail to trigger any form of risk assessment. A regulatory
definition that is too narrow in size range, or which sets a very high threshold
for nanoscale content, will also arguably provide an incentive for many nano-
manufacturers to reformulate their ingredients to retain novel nano-properties
such as transparency, antibacterial activity, or bioavailability, possibly including
nanotoxicity, but with characteristics escaping any specific regulation and labeling
requirements. On the other hand, a definition that focuses on novel properties
rather than size criteria may prove technically difficult and expensive to imple-
ment in practice, presenting a further barrier to risk assessment. The wide var-
iance in nanomaterial definitions, both proposed and adopted, alongside the
strong lobbying for different positions, suggests both the unsettled nature of
definition-related decision making, and the uneasy accommodation of technical/
scientific, and sociopolitical considerations.
Lack of Validated Methods, Instrumentation, and Standards for Testing
At a fundamental level, there is a lack of effective tools and methods to detect,
measure, characterize, and therefore monitor nanomaterials in a range of differ-
ent media. Methods to identify and characterize nanomaterials in complex matri-
ces such as preparations, final formulations, food, cosmetics, and environmental
systems remain in development or at the prototypical stage (Hartmann et al.,
2014; ICCR, 2011; U.S. EPA, 2011). Furthermore, no single measurement
method can routinely determine whether a sample contains nanomaterials,
meaning that a range of measurement methods is required in any instance (JRC,
2012). None of the methods to detect, quantify, and characterize nanomaterials
in complex matrices has been proven to be fit-for-purpose or validated according
to accepted standards (Anklam, 2012). Furthermore, “significant difficulties” exist
in measuring polydisperse materials and it is “currently usually not possible” to
determine whether a sample of aggregated materials would be considered to
contain nanomaterials for regulatory purposes, if the size distribution of constitu-
ent primary particles must be determined (JRC, 2012, p. 9). The lack of multi-
purpose, multi-media nano-detection approaches means that workers, employers,
product manufacturers, and regulators are unable to perform routine monitor-
ing for known and unknown nanomaterials in real-life circumstances. It also
means that toxicologists performing testing struggle to understand exactly how
the physico-chemical characteristics of nanomaterials and particles change under
a range of testing circumstances and media and over time—despite it being
widely recognized that these characteristics are altered and that this has the
potential to affect their toxicity. In addition to a need for new instruments and
Risk Analysis of Nanomaterials 497

methods allowing for in situ characterization, a range of new standards, operating
procedures, and guidelines are also required for (eco)toxicological research on
nanomaterials. This is because (eco)toxicological methods were primarily devel-
oped for testing the safety of soluble chemicals and many of these may not be
suitable or capable of delivering reliable results for nanoparticles (Hartmann
et al., 2014).
International standards for terminology and nomenclature, characterization,
safety testing, and materials specification for nanotechnologies are also all still in
development (e.g., with initiatives currently underway within the ISO, OECD,
and elsewhere). Lack of basic scientific and technical knowledge has been a key
barrier to setting nanotechnology standards (Miles, 2010), however as with ear-
lier technologies (Jasanoff, 2006) standard setting is also plagued by politics. Key
actors in international standards development are typically also engaged in tech-
nology development (Busch, 2011). Debate surrounding how research should be
conducted and what kinds of toxicity testing will be admissible for regulatory risk
assessment is characterized by scientific uncertainty and arguments over both
logistical challenges for regulators and implications for the emerging industry.
The production of standards can therefore be understood as a social process,
reflecting actors’ interests, and a process of political negotiation, together with
emerging technical knowledge. This means that even assuming that relevant
instrumentation, methods, and standards will eventually be developed, they will
not be value-free and therefore are unlikely to be uncontested, or universally rec-
ognized. While there are therefore certainly challenges facing the development
of appropriate and agreed testing methods, instrumentation, and standards, it
seems concerning that thousands of products continue to be developed and
released onto the market in the absence of validated toxicity testing methods and
without standards for characterization and measurement that can be trusted by
scientific and regulatory communities.
Lack of Available Scientific Knowledge
The properties of nanomaterials that may contribute to an environmental or
health risk have been described as “complex and largely unknown” (Grieger
et al., 2012) and the lack of toxicological and exposure data (as well as the reli-
ance by regulators on data submitted by industry) has been identified as another
key barrier to robust nanomaterial risk assessment (U.S. EPA, 2011). A review
funded by the European Commission concluded that: “there is still insufficient
data available to conduct the in depth risk assessments required to inform the
regulatory decision making process on the safety of NMs [nanomaterials]”
(Johnston et al., 2013, p. 2). Similarly, another review has emphasized that
“multiple deficiencies of toxicity and exposure data make it impossible to per-
form sound risk assessment of ENMs [engineered nanomaterials]” (Hristozov,
Gottardo, Critto, & Marcomini, 2012, p. 880).
The difficulty of scientifically assessing the impact of nanomaterials on humans
and the environment is immense. In the first instance it is clear that it is not pos-
sible to simply extrapolate an understanding of nanomaterial toxicity from our
experience with the same material in bulk form (Owen & Handy, 2007). Second,
498 Georgia Miller and Fern Wickson

and as outlined above, there is a lack of appropriate and agreed methods and
standards for safety testing. Additionally however, the most important factor for
understanding toxicity is not necessarily the traditional dose metric of mass, but
rather varying physico-chemical characteristics such as size, size distribution, sur-
face area, surface charge, length, shape, agglomeration state, and solubility
(Oberd€
orster et al., 2005). These features differ for different nanomaterials as
well as for different forms or “species” of the same nanomaterial, including those
generated at different stages of a products’ lifecycle or through exposure of the
material to different environmental contexts. Many characteristics of nanomateri-
als can be altered through interaction with environmental factors such as pH,
salinity, water hardness, and the presence of organic matter (Handy & Owen,
2008; RCEP, 2008) and such changes can be encountered throughout the life
cycle of a product.
Uncertainty exists within basically all areas of risk assessment for nanomateri-
als (Grieger et al., 2009). For determining health and environmental effects,
knowledge gaps remain for information on dose-response relationships, modes
of action, aggregation states, effects from chronic exposure or multiple-sources,
fate and biodistribution, durability and biopersistence, multitrophic effects, differ-
ences across species, and the potential for intergenerational transfer and harm.
There has also been very little research investigating the potential for additive or
synergistic effects, although research on interactions between nanomaterials and
endocrine disrupting chemicals (Zheng et al., 2012), and nanomaterials and orga-
nochlorines (Shi et al., 2010), indicates at least a potential for harm from such
effects. Information on all of these factors is required to perform scientific risk
assessment of nanomaterials. However, toxicity testing on just the nanomaterials
currently commercially available may take decades to complete and require the
investment of over US$1 billion (Choi, Ramachandran, & Kandlikar, 2009).
Despite this, the consistent calls for an increased level of funding for nano(eco)-
toxicology typically remain unanswered (Editor, 2008) creating the problem that
while we are investing heavily in the development of nanotechnology, there is no
commensurate level of investment in environment, health, and safety research. A
further and foundational problem is that it is unclear whether or not the uncer-
tainty surrounding nanomaterials’ biological fate and behavior will be eliminated
with further research, or whether new frontiers of uncertainty will continue to
emerge.
No Reliable Information Regarding Commercial Use
Compounding the issues of a lack of an agreed definition, appropriate methods,
and required research, there is also currently no reliable data on the commercial
use of nanomaterials and therefore on contemporary exposures. In most coun-
tries, disclosure of commercial use of nanomaterials is not mandatory and volun-
tary provision of information by industry has been extremely low (Breggin,
Falkner, Jaspers, Pendergrass, & Porter, 2009; NICNAS, 2010b; U.S. EPA, 2009).
In the absence of mandatory labeling or notification laws, unions have empha-
sized that employers and employees in many workplaces will be unaware that
nanomaterials are in use (Mullins, 2010). Technical, resource, and information
Risk Analysis of Nanomaterials 499

processing limitations constrain the ability of regulators to identify nanomaterials
in commercial use, along with the reliance on industry data (U.S. EPA, 2011).
The French government has been the first to implement a mandatory system
for reporting annual import, manufacture, and supply of manufactured nanoma-
terials and the mixtures that contain them, as of January 2013 (La Republique
Franc¸aise, 2012). Although the scheme has some limitations (for example not
including many types of imported finished products that contain nanomaterial
additives), by taking legally enforceable action to require companies to provide
information on their use of manufactured nanomaterials, France has been her-
alded as a world leader. Nonetheless, there are grounds to doubt the extent to
which the new edict will be implemented. For example, the penalty for non-
compliance (nonreporting) is a maximum of e3,000, plus a daily fine of e300
after a company has been found to be in breach, until compliance is achieved
(La Republique Franc¸aise, 2012). This may well be below the costs to companies
of establishing measurement, monitoring, and supply chain tracking systems
required to enable compliance, potentially creating an economic disincentive to
comply. Furthermore, many companies may be unaware that they are handling
nanomaterials at all. The chair of Business Europe’s occupational health and
safety committee has given a personal estimate that 99% of European employers
are unaware of the presence of nanomaterials in the supply chains for which
they have responsibility (De Meester, 2011). Without massive resourcing for a
vigorous outreach, education, and enforcement effort by regulators, the French
scheme may fail to capture much commercial use. Controversially, a report com-
missioned by the Australian government concluded that enforcement of a man-
datory reporting scheme for nanomaterials may not be technically feasible (CIE,
2012).
The lack of information regarding nanotechnology’s commercial use means
that producers, consumers, and regulators are all blind to potential exposures,
inhibiting the ability to conduct scientific risk assessment and to implement man-
agement measures. This can be seen as a reflection of the range of factors identi-
fied above, alongside a failure to require companies to disclose where they are
using or supplying nanomaterials, adequately resource outreach and enforce-
ment efforts by regulators, establish formal processes to coordinate the utilization
and dissemination of potentially mandated information, and develop industry
awareness regarding the presence of nanomaterials.
Practical Barriers to Exposure Mitigation in Global Workplaces
Given an inability to establish whether “safe” levels of occupational exposure
exist or what they may be, the UK Royal Society and Royal Academy of Engi-
neering recommended that “factories and research laboratories treat manufac-
tured nanoparticles and nanotubes as if they were hazardous” (RS/RAE, 2004,
p. 46). A range of measures to mitigate workplace exposures have been recom-
mended by workplace safety bodies in many OECD countries, including engi-
neering control systems, personal protective equipment, and safety systems (BSI,
2007; CDC, 2009; Safe Work Australia, 2012). Where implemented, such meas-
ures may significantly reduce workplace exposure, although safety bodies have
500 Georgia Miller and Fern Wickson

cautioned that given the historical experience with micro-scale powders and
gases, they are unlikely to prevent it (HSE, 2004). However, a major concern is
that financial, practical, and information barriers will limit the use of these
emerging control measures. As noted above, without mandatory labeling and
supply chain notifications, employers and workers may be unaware that manufac-
tured nanomaterials are in use. Even where nanomaterials have been identified,
there are still relatively few nanomaterial-specific Safety Data Sheets, and those
that exist generally provide insufficient information to manage workplace risks
(Lee et al., 2012; Safe Work Australia, 2010).
Moreover, it appears improbable that sophisticated and costly control systems,
and rigorous workplace practice, will be implemented for the hundreds of thou-
sands of low-paid workers engaged in handling, packaging, or transporting
nano-products, or cleaning or maintaining these workplaces, across various
nations and locations. Outside laboratories where nanomaterials are manufac-
tured, access to sophisticated control and safety processes may be significantly
curtailed. There may be no expectation that such systems will be provided to
those performing what will be perceived as relatively mundane tasks such as
packaging and handling (HSE, 2004). This means that even where information
concerning exposure is available, risk management may still be prohibited by
economic and capacity constraints, raising serious ethical issues concerning justice
and fairness for workers in international production chains.
Discussion
Nanotechnology’s Naked Emperor
Our review has identified at least six major barriers to reliable scientific risk
assessment of nanomaterials. These include a lack of: nano-specific regulatory
requirements, shared definitions, validated and accessible methods for safety test-
ing, available scientific knowledge, reliable information on commercial use, and
capacity for exposure mitigation. In short, the required regulatory frameworks
and definitions, research methods and standards, as well as overarching knowl-
edge and capacity, to perform scientific risk assessment of nanomaterials are all
lacking. Furthermore, each of these remain the focus of competing claims and
political contestation. The political will to slow rapid product commercialization,
to provide the considerable resources necessary to develop technical and material
knowledge, and to improve the social accountability of risk analysis and regula-
tory processes, also does not appear to exist. Reliable “scientific” risk assessment
capable of protecting human health and the environment in the face of accelerat-
ing nanoscale development is not possible now, and it is unclear whether it will
be in the future. Finally, without transparent information on where manufac-
tured nanomaterials are being used in commercial products and their product
chains, the ability to manage potential risks through hazard or exposure mitiga-
tion is severely curtailed.
In the fable of “The Emperor’s New Clothes,” the emperor walks through the
streets with everyone but an innocent child too scared to point out that he is
Risk Analysis of Nanomaterials 501

naked. We see a parallel situation for nanotechnology development, where despite
the obvious limitations currently facing the practice of scientific risk analysis, no
one seems to have the courage to admit that the emperor is not wearing any
clothes. Given the serious implications for policies designed to protect health and
the environment, it is interesting to reflect on why this might be so.
In this article, we have chosen to adopt the position of the child and draw
attention to this naked emperor, believing that by highlighting the inability of sci-
entific risk analysis to effectively control and govern the nano empire, we open
the possibility for exploring alternatives that may improve public policy in this
domain. However, few stakeholders in the nanotechnology debate have been will-
ing to acknowledge the extent and significance of the barriers to risk assessment
and risk management of nanomaterials, or to argue that an alternative or more
precautionary approach to nanotechnology oversight may be required. The
unwillingness of some observers to acknowledge the significance of the limitations
facing scientific risk analysis may be linked to a (rational) fear of being given the
irrational label of being “anti-science” or “anti-progress.” In previous technologi-
cal controversies, attempts to express dissent from outside a risk-based frame or
to draw attention to and call for regulatory action in the face of scientific uncer-
tainty were quickly labeled as “anti-science” views. This is despite the fact that
such arguments are often premised on alternative visions of a desirable sociotech-
nical future or an emphasis on the significance of “trans-scientific” questions
(Loveridge & Saritas, 2009; Royal Commission on Environmental Pollution,
2008; Weinberg, 1972). Support for risk analysis in the face of glaring challenges
may also reflect a fatalistic belief that this is the best we can hope for and/or the
only available tool by which science can help inform policy to protect human and
environmental health.
However, the reluctance to acknowledge the seriousness of the barriers to risk
analysis may also reflect the investment of many stakeholders in nanotechnol-
ogy’s future. There is a sense in which government, industry, and the research
community all now view nanotechnology as essential to maintaining economic,
scientific, and military competitiveness (Jamison, 2009; Whitman, 2007). That is,
governments, industry, and scientists alike are committed to maximizing their
performance in the emerging international race to build the nano empire. Gov-
ernment statements on risk regulation emphasize the dual goal of protecting
health and safety while maximizing trade and economic growth. In a statement
on the policy principles for nanotechnology regulation, U.S. President Obama
was quoted as stating that: “Our regulatory system must protect public health,
welfare, safety, and our environment while promoting economic growth, innova-
tion, competitiveness, and job creation” (ETIPC, 2011). The Australian govern-
ment has touted the limited nature of domestic regulation as an incentive to
invest in its nano-sector, claiming that Australia has: “the fewest restrictions on
product markets of the 30 OECD countries, the least public ownership of busi-
ness and the least restrictive impact of business regulation on economic behav-
iour” (DIISR, 2011, p. 10). Scientists have also expressed concern that the
governance of nanotechnology risks may be compromised by the economic moti-
vations of both government and industry (Hansen, Maynard, Baun, & Tickner,
2008). A fear of a loss of competitive position and power, or of legitimizing calls
502 Georgia Miller and Fern Wickson

for greater restrictions on the sector’s growth, therefore seems a disincentive to
acknowledging that the emperor is naked.
If it is impossible now and in the foreseeable future to conduct reliable risk
assessment on manufactured nanomaterials and to implement effective risk man-
agement measures, calls for a moratorium on commercial use of nanomaterials
(e.g., as made by many NGOs [Miller & Scrinis, 2010]), or even a permanent ban
(Strand & Kjølberg, 2011), arguably demand more serious consideration. Indeed,
given the situation we have outlined above, a moratorium on commercialization
could arguably be the most “scientifically sound” approach to governance
(Wickson, 2011).
What If We Acknowledge that the Emperor Is Naked?
What can we do once we have acknowledged that the emperor has no clothes?
In the fable, the emperor continued to walk through the crowd, naked, aware,
but blindly continuing. When the protection of public health and environmental
safety is at stake, and given the substantive range of societal and ethical dimen-
sions that both fall outside the narrow risk frame and lie unrecognized within it,
this does not seem like a satisfactory way to proceed. So far, governments have
responded to nanotechnology uncertainties by pledging support for more
research to fill in the knowledge gaps, to reduce uncertainty, and to bolster confi-
dence in risk assessment. We agree that research into both nano(eco)toxicology
and questions of exposure should receive dramatically increased funding. How-
ever, we also see that the uncertainty, ambiguity, and ignorance plaguing the
nanotechnology sector may not necessarily be reduced over time (Groves, 2009).
While we recognize the emergence of new frameworks for risk analysis that may
improve conventional practices (e.g., Grieger et al., 2012), given its many defi-
ciencies and the broad range of issues that fall outside the risk paradigm, it may
be time to release the monopoly that risk analysis has over the governance of the
nano empire.
The question then is how should we approach decision making, and what else
might be done to support and assist it? One of the significant approaches that
has been pursued to supplement risk assessment for the nano empire has been
the facilitation of enhanced public engagement in science development, debates,
and decision making (Gavelin, Wilson, & Doubleday, 2007). In principle, improv-
ing and enhancing public engagement has value and importance both for democ-
ratizing science and technology and providing an alternative epistemology for its
regulation. However, public engagement activities that have been performed on
nanotechnologies to date have unfortunately tended to also operate within a dis-
course of risk and be confined to the terms of risk regulation, have very little
direct connection to policy making, and largely be oriented toward building pub-
lic acceptance for what is perceived as a potentially controversial technology
(Delgado, Kjolberg, & Wickson, 2011; Lyons & Whelan, 2010). This means that
although this approach may perform better in terms of offering a broader episte-
mological base and potentially enhanced democratic accountability (although this
factor would be significantly improved if public engagement exercises were more
directly linked to policy or innovation processes), as currently practiced it has
Risk Analysis of Nanomaterials 503

largely failed to operate within a wider acknowledgment of the issues at stake.
However, other available decision-aiding tools that are already well developed
and established with a broader risk frame include tools such as multicriteria map-
ping (Stirling, 2009), problem formulation and options assessment (Nelson &
Banker, 2007), pedigree assessment (Craye, Funtowicz, & van der Sluijs, 2005),
constructive technology assessment (Schot & Rip, 1997), and/or real-time technol-
ogy assessment (Guston & Sarewitz, 2002). Whereas it is beyond the scope of this
article to examine the potential of each of these approaches in depth, it is worth
noting that while many of them have been trialed and applied in the field of
nanotechnology, this has been restricted to performance for research rather than
regulatory purposes and further work remains to integrate the use of such
approaches into government decision making with legally binding outcomes.
The uptake and integration of such approaches into government decision
making on new and emerging technologies would, however, arguably benefit
from the articulation of the relevance and importance of developing a “values-
based” as opposed to “science-based” approach to assessment and decision mak-
ing. Such an approach would of course seek to be informed by the best available
science, but acknowledging the limitations and uncertainties associated with the
state of scientific knowledge in the nano field, it would not pretend to be
“science-based.” Instead, it would seek its base in a set of articulated social values
and goals, which may be pursued through either a representative or deliberative
approach to democratic decision making. A values-based approach to decision
making would arguably involve further research and work to advance the delib-
eration over our orientation frame, such as the meaning of the good life, the
core societal and environmental challenges that need addressing, and/or the
overarching goal of human communities or civilization, and the extent to which
certain fields of science and technology development have the potential to con-
tribute to or further this. Such an approach would represent the development of
a kind of positive ethics (Nydal & Strand, 2008) in which the search is not just to
avoid bad, but to actively pursue good, and specifically, a good conceptualized
more broadly than simply economic growth. Such an approach may do best to
include broad-based deliberative processes and to focus on the interrogation,
exploration, and development of both innovation and regulatory policy,
“opening up” technology appraisal and directly considering the directionality of
development and decision making under conditions of scientific uncertainty.
While developing a values-based approach may sound far fetched, with very
little grounding in the practice of technological innovation or policy making, in
fact it can be seen to align rather closely with an academic and policy discourse
that is currently rapidly rising to prominence within the governance of new and
emerging technologies, namely that of “responsible research and innovation”
(RRI). RRI is emerging to be defined as referring to research and innovation
that has: an explicit focus on addressing serious societal and environmental chal-
lenges; active engagement a range of public stakeholders for the purpose of
mutual learning; a concerted effort to anticipate potential problems and reflect
on underlying values, assumptions, and beliefs; and a willingness to adapt and
respond accordingly (e.g., see Owen et al., 2013; van den Hoven et al., 2013;
von Schomberg, 2013; Wickson & Carew, 2014). Although still nascent, RRI is
504 Georgia Miller and Fern Wickson

arguably emerging as a prominent innovation policy discourse at exactly this
point in history precisely because of the challenges in advancing good gover-
nance in novel technological fields such as nanotechnology where there are seri-
ous barriers to our ability to predict and control interactions and impacts.
Indeed, the need for “responsible” research and development has been central
and consistently emphasized within the European policy discourse on nanotech-
nology (e.g., see European Commission, 2004, 2008, 2013). Future research is
needed to examine and empirically document the extent to which the new Euro-
pean framing of RRI within a 6 keys approach (European Commission, 2012)
recognizes and advances the potential novelty of RRI as an innovation policy dis-
course offering an alternative to a reliance on prediction and control, and the
extent to which this discourse effectively challenges and improves R&D practice
in nanotechnology.
Of course, so long as the notion of responsibility is conceptualized purely as
liability or accountability (see Pellizzoni, 2004), or coupled to consequences that
we can control, it loses its experimental potential as a novel governance tool
(Funtowicz & Strand, 2011). However, if the characteristics of care and respon-
siveness are emphasized in the meaning of responsibility, then it may indeed
have the potential to promise something new. It could enable the development
of a values-based approach to decision making by opening for debate the aspira-
tions, norms, and assumptions that shape scientific research, technological trajec-
tories, and the desirable futures they imply. An inclusive values-based approach
to decision making, informed by the best available science, may serve to remedy
some of the deficiencies that have been identified in risk analysis, that is, its
exclusion of key societal dimensions, its epistemological underdetermination, and
its lack of democratic accountability. Serious questions remain, however, concern-
ing how such an approach can be articulated and operationalized in practice,
how it would interact with competing political and economic pressures, what
would ground its legitimacy, and how it could be evaluated for its quality and
social inclusion. Indeed, we suggest that all of these questions offer a fruitful and
promising basis for further research. Given the substantial barriers facing the
dominant practice of risk analysis that we have highlighted in this article, we see
constructive engagement with and development of the idea of a “scientifically
informed” but “values-based” approach to decision making for new and emerg-
ing technologies (including all of the questions related to this outlined above), as
a necessary step in the further development of appropriate alternatives to the
dominance of risk analysis and its naked emperor status within the field of
nanotechnology.
Conclusion
In this review article, we have argued that just as in the fable, the emperor of the
emerging nanotechnology empire is naked. Effective and reliable scientific risk
analysis of nanomaterials is not possible now, nor will it be in the foreseeable
future. The barriers to its achievement are scientific, economic, political, and
practical. We have pointed to some additional tools and methods that could also
Risk Analysis of Nanomaterials 505

be used to aid and inform decision making, and have asked the provocative ques-
tion of what a scientifically informed but “values-based” decision making may
involve and offer. The moral of the story here is not that we believe that we have
an adequate and uncontestable alternative to scientific risk analysis as a basis for
decision making, nor that we believe that there is a singular better alternative
that will be appropriate in all contexts for all technologies. Rather, we seek to
emphasize that it is time to move away from a na€
ıve technocratic approach to
decision making on nanotechnology predicated on scientific and risk analysis
capabilities that simply do not exist. Instead, we ask for a serious reconsideration
of our expectations of risk and its sufficiency as the primary tool for informing
and operationalizing policy in this emerging field of technoscience and urge an
opening up of the frame and possibilities for what can be deemed relevant and
important in the governance of the new and rapidly expanding nano empire.
Acknowledgments
Fern Wickson gratefully acknowledges the following financial support for the
work done in this paper: Funding from the Norwegian Research Council (Grant
Numbers 203288 & 239199) and the European Commission (Grant Agreement
310584).
About the Authors
Georgia Miller is a PhD candidate in Science and Technology Studies within the School of
Humanities & Languages at the University of New South Wales. Her PhD thesis explores
how socio-technical imaginaries drive innovation policy and are mobilized within it, and
the co-production of knowledge in policy and regulatory processes. Georgia was
previously the coordinator of Friends of the Earth Australia’s nanotechnology project and
was a member of the Ministerial Stakeholder Advisory Council under the National
Enabling Technologies Strategy.
Fern Wickson is a scientist and program coordinator of the Society, Ecology and Ethics
Department at Genøk Centre for Biosafety in Norway. She is a member of the Norwegian
Biotechnology Advisory Board and President of the international Society for the Study of
Nanoscience and Emerging Technologies (S.Net). She also serves on the board of the
European Network of Scientists for Social and Environmental Responsibility (ENSSER)
and is involved in the Intergovernmental Panel on Biodiversity and Ecosystem Services
(IPBES). Dr. Wickson publishes for both social and natural science audiences (in high-evel
journals such as Nature Nanotechnology, Public Understanding of Science, and Ecological
Economics) and is the editor of the anthology Nano Meets Macro: Social Perspectives on
Nanoscale Sciences and Technologies.
References
Allhoff, F., Lin, P., & Moore, D. (2010). What is nanotechnology and why does it matter? From science to ethics.
Chichester, UK: Wiley.
Altmann, J. (2010). Military applications: Special conditions for regulation. In G. A. Hodge, D. M. Bowman,
& A. D. Maynard (Eds.), International handbook on regulating nanotechnologies (pp. 372–388). Cheltenham,
UK: Edward Elgar Publishing Inc.
506 Georgia Miller and Fern Wickson

Anklam, E. (2012). Nanoparticles in the food chain: Challenges for legislators, industry and control laborato-
ries. Food-Lab International,1, 8–10.
APEC. (2002). Nanotechnology: The technology for the 21st century. Volume 2 the full report. Bangkok: Author.
Beck, U. (1992). Risk society: Towards a new modernity. London: Sage.
Bowman, D. M. (2007). Patently obvious: Intellectual property rights and nanotechnology. Technology in
Society,29(3), 307–315.
Bowman, D. M., & Hodge, G. A. (2007). A small matter of regulation: An international review of nanotech-
nology regulation. The Columbia Science and Technology Law Review,8, 1–36.
Breggin, L., Falkner, R., Jaspers, N., Pendergrass, J., & Porter, R. (2009). Securing the promise of nanotechnolo-
gies: Towards transatlantic regulatory cooperation. London: Chatham House.
BSI. (2007). Nanotechnologies—Part 2: Guide to safe handling and disposal of manufactured nanomaterials ICS
13.100; 71.100.99. London: Author.
Busch, L. (2011). Standards: Recipes for reality. Cambridge, MA: The MIT Press.
CDC. (2009). Approaches to safe nanotechnology: Managing the health and safety concerns associated with engineered
nanomaterials. DHHS (NIOSH) Publication No. 2009–125. Cincinnati, OH: Author.
Chaudhry, Q., Bouwmeester, H., & Hertel, R. F. (2010). The current risk assessment paradigm in relation
to the regulation of nanotechnologies. In G. A. Hodge, D. M. Bowman, & A. D. Maynard (Eds.),
International handbook on regulating nanotechnologies (pp. 124–143). Cheltenham, UK: Edward Elgar
Publishing Inc.
Choi, J.-W., Ramachandran, G., & Kandlikar, M. (2009). The impact of toxicity testing costs on nanomaterial
regulation. Environmental Science and Technology,43, 3030–3034.
CIE. (2012). Feasibility of implementing a mandatory nanotechnology product registry. Prepared for (Australian)
Department of Innovation, Industry, Science and Research. Canberra: Author.
Cientifica. (2011). Global funding of nanotechnologies and its impact. London: Author. Retrieved from http://
cientifica.com/wp-content/uploads/downloads/2011/07/Global-Nanotechnology-Funding-Report-2011.pdf
Craye, M., Funtowicz, S., & van der Sluijs, J. (2005). A reflexive approach to dealing with uncertainties in
environmental health risk science and policy. International Journal of Risk Assessment,5, 216–236.
Davies, S., Macnaghten, P., & Kearnes, M. (2009). Reconfiguring responsibility: Lessons for public policy. Part 1 of
the report on Deepening Debate on Nanotechnology. Durham, UK: Durham University.
Delgado, A., Kjolberg, K. L., & Wickson, F. (2011). Public engagement coming of age: From theory to prac-
tice in STS encounters with nanotechnology. Public Understanding of Science,20(6), 826–845.
De Meester, K. (2011). Working with nanomaterials: Employer’s viewpoint. Paper presented at the Working with
nanomaterials: A seminar on policy, practice and the role of public authorities in dealing with uncer-
tain risks, Brussels.
DIISR. (2011). Nanotechnology: Australian Capability Report Fourth Edition. Barton, ACT: Author.
DITR. (2006). Options for a National Nanotechnology Strategy: Report to Minister Industry, Tourism and Resources by
the National Nanotechnology Strategy Taskforce, June 2006. Canberra, ACT: Australian Government.
Donaldson, K., Stone, V., Clouter, A., Renwick, L., & MacNee, W. (2001). Ultrafine particles. Occupational
and Environmental Medicine,58, 211–216.
Duvall, M., & Wyatt, A. (2011). Regulation of nanotechnology and nanomaterials at EPA and around the world:
Recent developments and context. Washington, DC: Beveridge & Diamond, P.C.
Editor. (2008). The same old story. Nature Nanotechnology,3, 699–700.
ECHA. (n.d.). Nanomaterials. Retrieved from http://echa.europa.eu/regulations/nanomaterials
EFSA. (2011). Scientific opinion: Guidance on the risk assessment of the application of nanoscience and nanotechnolo-
gies in the food and feed chain. Parma, Italy: Author. Retrieved from http://www.efsa.europa.eu/en/efsa-
journal/doc/2140.pdf
Eisenberger, I., Nentwich, M., Fiedler, U., Gazso, A., & Simko, M. (2010). Nano regulation in the European
Union. Nano Trust Dossiers,17, 1–6.
ETIPC. (2011). Policy principles for the U.S. decision-making concerning regulation and oversight of applications of
nanotechnology and nanomaterials. Washington DC: Author. Retrieved from http://www.whitehouse.gov/
sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf
European Commission. (2004). Communication from the Commission—Towards a European strategy for nanotechnology.
Luxembourg: Office for Official Publications of the European Communities.
European Commission. (2008). Commission recommendation of 07/02/2008 on a code of conduct for responsible
nanosciences and nanotechnologies research. Brussels: Commission of the European Communities.
European Commission. (2009a). Commission recommendation on a code of conduct for responsible nanosciences and
nanotechnologies research and council conclusions on responsible nanosciences and nanotechnologies research. Lux-
embourg: Author.
European Commission. (2009b). Regulation (EC) No 1223/2009 of the European Council and of the Parlia-
ment of 30 November 2009 on cosmetic products. Official Journal of the European Union,L342, 59–209.
Risk Analysis of Nanomaterials 507

European Commission. (2011). Commission recommendation of 18 October 2011 on the definition of nano-
material. Official Journal of the European Union,275, 38–40.
European Commission (2012). Responsible research and innovation: Europe’s ability to respond to societal
challenges. Retrieved from http://ec.europa.eu/research/science-society/document_library/pdf_06/
responsible-research-and-innovation-leaflet_en.pdf
European Commission. (2013). EUR 13325–Nanotechnology: The invisible giant tackling Europe’s future chal-
lenges. Luxembourg: Publications Office of the European Union.
Falkner, R., & Jaspers, N. (2012). Regulating nanotechnologies: Risk, uncertainty and the global governance
gap. Global Environmental Politics,12(1), 30–55.
Faunce, T. A. (2009). Policy challenges of nanomedicine for Australia’s PBS. Australian Health Review,33(2),
258–267.
Faunce, T. A., & Watal, A. (2010). Nanosilver and global public health: International regulatory issues. Nano-
medicine,5(4), 617–632.
Ferrari, A. (2009). Controlling the ethics of nanorisks. In S. Arnaldi, A. Lorenzet, & F. Russo (Eds.), Technos-
cience in progress. Managing the uncertainty of nanotechnology (pp. 113–128). Amsterdam: IOS Press.
Funtowicz, S. O., & Ravetz, J. R. (1993). Science for the post-normal age. Futures,25(7), 739–755.
Funtowicz, S. & Strand, R. (2011). Change and commitment: Beyond risk and responsibility. Journal of Risk
and Responsibility 14(8), 995–1003.
Gavelin, K., Wilson, R., & Doubleday, R. (2007). Democratic technologies? The Final Report of the Nanotechnology
Engagement Group (NEG). London: Involve.
Gottweis, H. (1998). Governing molecules: The discursive politics of genetic engineering in Europe and the United
States. Cambridge, MA: MIT Press.
Grieger, K. D., Hansen, S. F., & Baun, A. (2009). The known unknowns of nanomaterials: Describing and
characterizing uncertainty within environmental, health and safety risks. Nanotoxicology,3(3), 222–233.
Grieger, K. D., Linkov, I., Hansen, S. F., & Baun, A. (2012). Environmental risk analysis for nanomaterials:
Review and evaluation of frameworks. Nanotoxicology,6(2), 196–212.
Grobe, A. (2010). Responsible use of nanotechnologies: Report and recommendations of the German NanoKommission
2011. Berlin: Federal Ministry for the Environment, Nature Conservation and Nuclear Safety.
Groves, C. (2009). Nanotechnology, contingency and finitude. Nano Ethics,3(1), 1–16.
Groves, C. (2011). Public engagement and nanotechnology in the UK: Restoring trust or building robust-
ness? Science and Public Policy,38(10), 783–793.
Guston, D., & Sarewitz, D. (2002). Real-time technology assessment. Technology in Society,24(1-2), 93–109.
Handy, R., & Owen, R. (2008). The ecotoxicology of nanoparticles and nanomaterials: Current status,
knowledge gaps, challenges and future needs. Ecotoxicology,17, 315–325.
Hansen, S. F., Maynard, A., Baun, A., & Tickner, J. A. (2008). Late lessons from early warnings for nano-
technology. Nature Nanotechnology,3(8), 444–447.
Hartmann, N., Skjolding, L., Foss Hansen, S., Baun, A., Kjølholt, J., & Gottschalck, F. (2014). Environmental
fate and behaviour of nanomaterials: New knowledge on important transformation processes. Environmental
Project No. 1594. Copenhagen: The Danish Environmental Protection Agency.
Helland, A., Kastenholtz, H., Thidell, A., Arnfalk, P., & Deppert, K. (2006). Nanoparticulate materials and
regulatory policy in Europe: An analysis of stakeholder perspectives. Journal of Nanoparticle Research,8,
709–719.
House of Lords Science and Technology Committee. (2009). Inquiry into nanotechnologies and food. Examination
of Witnesses (Questions 260–277). London: UK Parliament.
Hristozov, D., Gottardo, S., Critto, A., & Marcomini, A. (2012). Risk assessment of engineered nanomateri-
als: A review of available data and approaches from a regulatory perspective. Nanotoxicology, doi:
10.3109/17435390.2011.626534
HSE. (2004). Nanoparticles: An occupational hygiene review. Prepared by the Institute of Occupational Medicine for
the Health and Safety Executive 2004. Research Report 274. Norwich, UK: Author.
ICCA. (2010). ICCA core elements of a regulatory definition of manufactured nanomaterials. Retrieved from
http://www.icca-chem.org/ICCADocs/Oct-2010_ICCA-Core-Elements-of-a-Regulatory-Definition-of-
Manufactured-Nanomaterials.pdf
ICCR. (2011). Report of the Joint Regulator—Industry Ad Hoc Working Group: Currently Available Methods for
Characterization of Nanomaterials. Retrieved from http://ec.europa.eu/consumers/sectors/cosmetics/files/
pdf/iccr5_char_nano_en.pdf
Insight Investment, Royal Society, Centre for Process Innovation and Nanotechnology Industries Assoscia-
tion. (2008). Responsible Nano Code. Retrieved from http://www.nanoandme.org/downloads/
The%20Responsible%20Nano%20Code.pdf
Invernizzi, N., Foladori, G., & Maclurcan, D. (2008). Nanotechnology’s controversial role for the south.
Science, Technology & Society,13(1), 123–148.
508 Georgia Miller and Fern Wickson

Jamison, A. (2009). Can nanotechnology be just? On nanotechnology and the emerging movement for
global justice. Nanoethics,3, 129–136.
Jarvis, D. S., & Richmond, N. (2011). Regulation and governance of nanotechnology in China: Regulatory
challenges and effectiveness. European Journal of Law and Technology,2(3), 1–11.
Jasanoff, S. (1990). The fifth branch: Science advisors as policymakers. Cambridge, MA: Harvard University
Press.
Jasanoff, S. (1995). Product, process, or programme: Three cultures and the regulation of biotechnology. In
M. Bauer (Ed.), Resistance to new technology (pp. 311–331). Cambridge: Cambridge University Press.
Jasanoff, S. (1999). The songlines of risk. Environmental Values,8, 135–152.
Jasanoff, S. (2005). Designs on nature: Science and democracy in Europe and the United States. Princeton, NJ:
Princeton University Press.
Jasanoff, S. (2006). Biotechnology and empire: The global power of seeds and science. Osiris,21, 273–292.
Johnston, H., Pojana, G., Zuin, S., Jacobsen, N. R., Møller, P., Loft, P., et al. (2013). Engineered nanomate-
rial risk. Lessons learnt from completed nanotoxicology studies: Potential solutions to current and
future challenges. Critical Reviews in Toxicology,43(1), 1–20.
JRC. (2012). Requirements on measurement for the implementation of the European Commission definition of the term
“nanomaterial.” Geel, Belgium: European Commission Joint Research Centre, Institute for Reference
Materials and Measurements.
Kearnes, M., Grove-White, R., Macnaghten, P., Wilsdon, J., & Wynne, B. E. (2006). From bio to nano: Learning
lessons from the UK agricultural biotechnology controversy. Science as Culture,15(4), 291–307.
Kjølberg, K. & Wickson, F. (2010). Nano meets macro: Social perspectives on nanoscale sciences and technologies.
Singapore: Pan Stanford Publishing.
Kleinman, D. L. (2005). Science and technology in society: From biotechnology to the internet. Malden, MA: Black-
well Publishing.
Kvakkestad, V., Gillund, F., Kjølberg, K., & Vatn, A. (2007). Scientists’ perspectives on the deliberate release
of GM crops. Environmental Values,16, 79–104.
La Republique Franc¸aise. (2012). D
ecret no 2012-232 du 17 f
evrier 2012 relatif 
alad

eclaration annuelle
des substances 
al’

etat nanoparticulaire pris en application de l’article L. 523-4 du code de l’environne-
ment. NOR : DEVP1123456D. Paris: Journal Officiel de la Republique Francaise. Retrieved from http://
www.legifrance.gouv.fr/jopdf/common/jo_pdf.
jsp?numJO=0&dateJO=20120219&numTexte=4&pageDebut=02863&pageFin=02865.
Lee, J. H., Kuk, W. K., Kwon, M., Lee, J. H., Lee, K. S., & Yu, I. J. (2012). Evaluation of information in nanoma-
terial safety data sheets and development of international standard for guidance on preparation of nano-
material safety data sheets. Nanotoxicology, doi:10.3109/17435390.2012.658095
Levidow, L. (2007). European public participation as risk governance: Enhancing democratic accountability
for agbiotech policy? East Asian Science, Technology and Society: an International Journal,1, 19–51.
Loveridge, D. & Saritas, O. (2009). Reducing the democratic deficit in institutional foresight programme: A
case for critical systems thinking in nanotechnology. Technological Forecasting and Social Change,76(9),
1208–1221.
Lyons, K., & Whelan, J. (2010). Community engagement to facilitate, legitimize and accelerate the advance-
ment of nanotechnologies in Australia. Nanoethics,4(1), 53–66.
Maclurcan, D., & Radwyl, N. (2012). Nanotechnology and global sustainability. Aarhus, Denmark: CRC Press.
Macnaghten, P., & Chilvers, J. (2012). Governing risky technologies. In M. Kearnes, F. Klauser & S. Lane
(Eds.), Critical risk research: Practices, politics and ethics (pp. 99–124). West Sussex, UK: Wiley-Blackwell.
Macnaghten, P., Kearnes, M., & Wynne, B. E. (2005). Nanotechnology, governance, and public deliberation:
What role for the social sciences? Science Communication,27(2), 1–24.
Maynard, A. D. (2006). Nanotechnology: assessing the risks. Nano Today,1(2), 22–33.
Maynard, A. D., Bowman, D. M., & Hodge, G. A. (2011). The problem of regulating sophisticated materials.
Nature Materials,10(8), 554–557.
McRay, P. (2013). The visioneers: How a group of elite scientists pursued space colonies, nanotechnologies, and a limit-
less future. Princeton, NJ: Princeton University Press.
Miles, J. (2010). Nanotechnology captured. In G. A. Hodge, D. M. Bowman, & A. D. Maynard (Eds.), Interna-
tional handbook on regulating nanotechnologies (pp. 83–106). Cheltenham, UK: Edward Elgar Publishing
Limited.
Miller, G. N., & Scrinis, G. (2010). The role of NGOs in governing nanotechnologies: Challenging the
“benefits versus risks” framing of nanotech innovation. In G. A. Hodge, D. M. Bowman, & A. D. May-
nard (Eds.), International handbook on regulating nanotechnologies (pp. 409–445). Cheltenham, UK:
Edward Elgar Publishing Limited.
Miller, G. N., & Scrinis, G. (2011). Nanotechnology and the extension and transformation of inequity. In S.
E. Cozzens & J. M. Wetmore (Eds.), Nanotechnology and the challenges of equity, equality and development,
Risk Analysis of Nanomaterials 509

Yearbook of Nanotechnology in Society (Vol. 2). Dordrecht, the Netherlands: Springer Science1Business
Media.
Morris, J. (2012). Risk, language and power: The nanotechnology environmental policy case. Plymouth, UK: Lex-
ington Books.
Mullins, S. (2010). Are we willing to heed the lessons of the past? Nanomaterials and Australia’s asbestos leg-
acy. In M. Hull & D. M. Bowman (Eds.), Nanotechnology environmental health and safety: Risks, regulation
and management (pp. 49–69). London: Elsevier.
Nel, A., Grainger, D., Alvarez, P., Badesha, S., Castranova, V., Ferrari, M., ... Wiesner, M. (2010). Nanotech-
nology environmental, health and safety issues. In M. Roco, C. Mirkin & M. Hersam (Eds.), Nanotech-
nology research directions for societal needs in 2020: Retrospective and outlook (pp. 107–156). Dordrecht:
Springer.
Nelson, K. C., & Banker, M. J. (2007). Problem formulation and options assessment handbook: International project
on GMO environmental risk assessment methodologies. Retrieved from http://www.gmoera.umn.edu/public/
science/pfoa.html
NICNAS. (2010a). Guidance on new chemical requirements for notification of industrial nanomaterials. Sydney: NIC-
NAS. Retrieved from http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Guidanceon New
Chemical Requirements for Notification of Industrial Nanomaterials.pdf
NICNAS. (2010b). Nanomaterials: Summary of 2008 call for information on the use of nanomaterials. Sydney:
Australian Government, Department of Health and Ageing. Retrieved from http://nicnas.gov.au/
Publications/Information_Sheets/General_Information_Sheets/NIS_Results_Call_for_Information_2008_
Nov_2010_PDF.pdf
NRC. (1983). Risk Assessment in the Federal Government: Managing the Process. Committee on the Institutional Means
for Assessment of Risks to Public Health. Washington, DC: Author.
NSTC. (2011). National Nanotechnology Initiative Strategic Plan. National Science and Technology Council Committee
on Technology: Subcommittee on Nanoscale Science, Engineering and Technology, February 2011. Washington,
DC: Executive Office of the President of the United States of America.
Nydal, R., & Strand, R. (2008). God nanoetikk—god nanoteknologiutvikling. Etikk i Praksis,2, 33–52.
Oberd€
orster, G., Maynard, A. D., Donaldson, K., Castranova, V., Fitzpatrick, J., Ausman, K. ... Yang, H.
(2005). Principles for characterizing the potential human health effects from exposure to nanomateri-
als: Elements of a screening strategy. Particle and Fibre Toxicology,2(8), 1–35.
OECD. (2011). Current developments/ activities on the safety of manufactured nanomaterials. Tour de Table
at the 8th Meeting of the Working Party on Manufactured Nanomaterials 16-17 March 2011, Paris,
France. No. 29 Series on the Safety of Manufactured Nanomaterials. ENV/JM/MONO(2011)12.
OECD. (2013). Recommendation of the Council on the Safety Testing and Assessment of Manufactured
Nanomaterials. 19 September 2013 - C(2013)107. Retrieved from http://acts.oecd.org/Instruments/
ShowInstrumentView.aspx?InstrumentID=298&InstrumentPID=314&Lang=en&Book=False
Owen, R., & Handy, R. (2007). Formulating the problems for environmental risk assessment of nanomateri-
als. Environmental Science and Technology,41, 5582–5588.
Owen, R., Stilgoe, J., Macnaghten, P., Gorman, M., Fisher, E., & Guston, D. (2013). A framework for respon-
sible innovation. In R. Owen, J. Bessant, & M. Heintz (Eds.), Responsible innovation: Managing the respon-
sible emergence of science and innovation in society (pp. 27–50). Chichester: Wiley.
Pellizzoni, L. (2004). Responsibility and environmental governance. Environmental Politics,13(3), 541–565.
Pidgeon, N., & Rogers-Hayden, T. (2007). Opening up nanotechnology dialogue with the publics: Risk com-
munication or “upstream engagement”? Health, Risk and Society,9(2), 191–210.
Powell, M. C. (2007). New risk or old risk, high risk or no risk? How scientists’ standpoints shape their
nanotechnology risk frames. Health, Risk and Society,9(2), 173–190.
Powers, C. M., Bale, A. S., Kraft, A. D., Makris, S. L., Trecki, J., Cowden, J., et al. (2013). Developmental
neurotoxicity of engineered nanomaterials: Identifying research needs to support human health risk
assessment. Toxicological Sciences,134(2), 225–242.
RCEP. (2008). Novel materials in the environment: The case of nanotechnology. Norwich, UK: Author.
Roco, M. (2011). The long view of nanotechnology development: The NNI at ten years. In M. Roco, C. Mir-
kin & M. Hersam (Eds.), Nanotechnology research directions for societal needs in 2020: Retrospective and out-
look (pp. 1–28). Dordrecht: Springer.
Roco, M. C. & Tomellini, R. (2002). Nanotechnology: Revolutionary opportunities and societal implications. Luxem-
burg: Office for Official Publications of the European Communities.
Royal Society and Royal Academy of Engineering (RS/RAE). (2004). Nanoscience and nanotechnologies: Opportu-
nities and uncertainties. London: Author.
Safe Work Australia. (2010). Research report: An evaluation of MSDS and labels associated with the use of engineered
nanomaterials. Canberra: Commonwealth of Australia.
Safe Work Australia. (2012). Safe handling and use of carbon nanotubes. March 2012. Canberra.
510 Georgia Miller and Fern Wickson

Savolainen, K., Pylkk€
anen, L., Norppa, H., Falck, G., Lindberg, H., Tuomi, T. ... Seipenbusch M. (2010).
Nanotechnologies, engineered nanomaterials and occupational health and safety—A review. Safety Sci-
ence,48(8), 957–963.
SCENIHR. (2006). The appropriateness of existing methodologies to assess the potential risks associated with engineered
and adventious products of nanotechnologies. Brussels: European Commission Directorate for Health &
Consumer Protection.
SCENIHR. (2010). Scientific basis for the definition of the term “nanomaterial.” Brussels: European Commission
Directorate General for Health & Consumers.
Schot, J., & Rip, A. (1997). The past and future of constructive technology assessment. Technological Forecast-
ing and Social Change,54(2-3), 251–268.
Schwirn, K., Tientjen, L., & Beer, I. (2014). Why are nanomaterials different and how can they be appropri-
ately regulated under REACH? Environmental Sciences Europe,26(4), 1–10.
Shapira, P., & Wang, J. (2010). Follow the money. Nature,468, 627–628.
Shi, Y., Zhang, J., Jiang, M., Zhu, L., Tan, H., & Lu, B. (2010). Synergistic genotoxicity caused by low con-
centration of titanium dioxide nanoparticles and p,p’-DDT in human hepatocytes. Environmental and
Molecular Mutagenesis,51(3), 192–204.
Sparrow, R. (2010). The slippery nature of nano-enthusiasm. In K. Kjølberg & F. Wickson (Eds.), Nano meets macro:
Socialperspectiveson nanoscalescience and technologies (pp. 123–137). Singapore: Pan Stanford PublishingLte Ltd.
Stamm, H. (2011). Nanomaterials should be defined. Science,476, 399.
Stilgoe, J. (2007). Nanodialogues: Experiments in public engagement with science. London: Demos.
Stilgoe, J., Owen, R., & Macnaghten, P. (2013). Developing a framework for responsible innovation. Research
Policy 42(9), 1568–1580.
Stirling, A. (Ed.). (2001). On science and precaution in the management of technological risk: Volume II—case studies:
European Commission Institute for prospective Technological Studies. Seville: European Commission JRC.
Stirling, A. (2005). 15jOpening up or closing down? Analysis, participation and power in the social appraisal
of technology.
Stirling, A. (2007). Risk, precaution and science: Towards a more constructive policy debate. Talking point
on the precautionary principle. EMBO Reports,8(4), 309–315.
Stirling, A. (2008). Science, precaution, and the politics of technological risk: Converging implications in evo-
lutionary and social scientific perspectives. Annals of the New York Academy of Sciences,1128, 95–110.
Stirling, A. (2009). Multicriteria mapping. Retrieved from http://www.multicriteria-mapping.org/
Strand, R., & Kjølberg, K. L. (2011). Regulating nanoparticles: The problem of uncertainty. European Journal
of Law and Technology,2(3), 1–10.
Sylvester, D. J., Abbott, K. J., & Marchant, G. E. (2009). Not again! Public perception, regulation, and nano-
technology. Regulation and Governance,3, 165–185.
U.S. EPA. (2009). Nanoscale materials stewardship program interim report. Washington DC: U.S. Environmental
Protection Agency, Office of Pollution Prevention and Toxics. Retrieved from http://www.epa.gov/oppt/
nano/nmsp-interim-report-final.pdf
U.S. EPA. (2011). EPA needs to manage nanomaterial risks more effectively. Report No. 12-P-0162. Washington
DC: Author.
U.S. EPA. (2015). Proposed rule: Chemical substances when manufactured or processed as nanoscale materials: TSCA
reporting and recordkeeping requirements. Retrieved from http://www.regulations.gov/#!documentDetail;
D=EPA-HQ-OPPT-2010-0572-0001
van den Hoven, J., Jacob, K., Nielsen, L., Roure, F., Rudze, L., & Stilgoe, J. (Eds.). (2013). Options for
strengthening responsible research and innovation: Report of the Expert Group on the State of the Art in Europe
on Responsible Research and Innovation. Luxembourg: Publications Office of the European Union.
van Lente, H., Coenen, C., Fleischer, T., Konrad, K., Krabbenborg, L., Milburn, C .... Zulsdorf, T. B.
(2012). Little by little: Expansions of nanoscience and emerging technologies. Heidelberg: Akademische
Verlagsgesellschaft.
von Schomberg, R. (2013). A vision of responsible innovation. In R. Owen, J. Bessant,. & M. Heintz (Eds.),
Responsible innovation: Managing the responsible emergence of science and innovation in society (pp. 51–74).
Chicester: Wiley.
Weinberg, A. M. (1972). Science and trans-science. Minerva,10(2), 209–222.
Whitman, J. (2007). The governance of nanotechnology. Science and Public Policy,34(4), 273–283.
Whitman, J. (2011). The arms control challenges of nanotechnology. Contemporary Security Policy,32(1),
99–115.
Wickson, F. (2008). Narratives of nature and nanotechnology. Nature Nanotechnology,3(6), 313–315.
Wickson, F. (2011). Technology: Nanomaterials need flexible regulation. Nature,476(7360), 283.
Wickson, F. & Carew, A.L. (2014). Quality criteria and indicators for responsible research and innovation:
Learning from transdisciplinarity. Journal of Responsible Innovation,1(3), 254–273.
Risk Analysis of Nanomaterials 511

Wickson, F., Grieger, K., & Baun, A. (2010). Nature and nanotechnology: Science, ideology and policy. Aus-
tralian Journal of Emerging Technologies and Society,8(1), 5–23.
Wickson, F., & Wynne, B. (2012). The anglerfish deception. The light of proposed reform in the regulation
of GM crops hides underlying problems in EU science and governance. EMBO Reports,13(2), 100–105.
Williams, D. (2010). The scientific basis for regulating nanotechnologies. In G. A. Hodge, D. M. Bowman, &
A. D. Maynard (Eds.), International handbook on regulating nanotechnologies. Cheltenham, UK: Edward
Elgar Publishing Inc.
Wolbring, G. (2008). Why NBIC? Why human performance enhancement? Innovation,21(1), 25–40.
Wolf, E. & Medikonda, M. (2012). Understanding the nanotechnology revolution. Weinheim: Wiley.
Wynne, B. (1992). Uncertainty and environmental learning. Reconceiving science and policy in the preven-
tive paradigm. Global Environmental Change,2(2), 111–127.
Wynne, B. (1996). May the sheep safely graze? A reflexive view of the expert-lay knowledge divide. In S.
Lash, B. Szerszynski, & B. Wynne (Eds.), Risk environment and modernity: Towards an new ecology (pp. 44–
83). London: Sage Publications Inc.
Wynne, B. (2001). Creating public alienation: expert cultures of risk and ethics on GMOs. Science as Culture,
10(4), 445–481.
Zheng, D., Wang, N., Wang, X., Tang, Y., Zhu, L., Huang, Z., et al. (2012). Effects of the interaction of
TiO2 nanoparticles with bisphenol A on their physicochemical properties and in vitro toxicity. Journal
of Hazardous Materials,199-200, 426–432.
512 Georgia Miller and Fern Wickson