Nano Today (2015) 10, 610

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NEWS AND OPINIONS

The challenges of nanotechnology risk

management
Tarek R. Fadel a, Jeffery A. Steevens b, Treye A. Thomas c,
Igor Linkov b,
a

International Technology Research Institute (ITRI, Inc.), Linthicum, MD, USA

U.S. Army Engineer Research and Development Center, Vicksburg, MS, USA
c
Consumer Product Safety Commission, Bethesda, MD, USA
b

Received 11 March 2014; received in revised form 7 September 2014; accepted 10 September 2014
Available online 22 October 2014

KEYWORDS
Risk management;
Risk assessment;
Decision analysis;
Policy;
Nanomaterials;
Regulations

Summary Recent developments in the design of advanced materials have furthered interest in the commercialization of new technologies. Central to this rapid technology revolution
is the consideration of the potential environmental, health, and safety (EHS) risks associated
with nanomaterials. Risk assessment has been proposed as a primary method to evaluate EHS
risk and decision making, where risk assessment practitioners seek to understand what can go
wrong, its likelihood of occurrence, and the ultimate consequences if it should arise. Here, we
outlined recent efforts geared toward risk assessment for nanotechnologies and nanomaterials,
and discuss the challenges associated with providing accurate risk information to policymakers
and regulators. Risk assessment that includes analytical approaches will provide decision makers with adaptive guidance regarding how to balance risks with technological benets and costs,
communicate those trade-offs, and change nanomaterial design toward sustainable nanotechnology.
Published by Elsevier Ltd.

Introduction

The thoughts and opinions expressed here are those of the

individual contributors alone and do not necessarily reect the
views of the National Nanotechnology Initiative or the U.S. Federal
Government.
Corresponding author. Tel.: +1 6172339869.
E-mail address: Igor.Linkov@usace.army.mil (I. Linkov).

http://dx.doi.org/10.1016/j.nantod.2014.09.008
1748-0132/Published by Elsevier Ltd.

Risk assessment has traditionally been thought of as the

evaluation of what can go wrong, how likely it is to happen,
and the consequences of it happening [1]. As a regulatory
platform, risk assessment has been the guiding principle for
the evaluation of environmental and product risks, including nano-enabled technologies [2]. In the case of chemicals
and nanomaterials, risk assessment has historically relied
on detailed, empirical data for exposure and hazard (e.g.,

The challenges of nanotechnology risk management

doseresponse models, which describe the change in effect
on a system caused by differing levels of exposure to a
stressor over a certain exposure time). This method of risk
assessment, referred to as a bottom-up approach, may not
be effective in researching the risks of fast-evolving, modern materials and technologies, as evidence alone does not
typically lead to a specic course of action. Objectivedriven approaches, referred to here as top-down methods,
rely on the acquisition of information and synthesis from
decision makers to drive actions. Top-down methods can
improve and expedite the risk assessment process by integrating technical information and expert judgment on an
emerging technology with human perceptions and values,
thus allowing stakeholders to assess the relative merits of
multiple risk-reduction alternatives. However, an important remaining challenge is to determine how to integrate
both bottom-up and top-down approaches to facilitate riskinformed decision-making [3].
The U.S. regulatory community and nanotechnology
industry continue to assess validated and reliable sciencebased methods and tools to augment existing approaches
for risk analysis and regulation of nanomaterials. Signicant
global efforts by government and private sector stakeholders to collect EHS risk information have resulted in a large
volume of data concerning nanomaterial fate and effects.
The value and application of this information to relevant
policy makers has been the subject of multiple national and
international efforts, including four workshops organized by
the NNI in 20092010 [4]. Various stakeholder communities
such as industry, workers, consumers, and non-government
organizations need assurance that these novel materials are
safe for use. Efforts by government decision makers and private sector stakeholders to collect EHS information have
helped build a large volume of data concerning nanomaterial
fate and effects. For example, federal agency approaches
to risk assessment stress the importance of basing any risk
decisions on the best available scientic data. Traditional
bottom-up approaches to risk assessment include gaining
information regarding the toxicity of a compound and determining limits for exposure and uptake into the body. Such
research must be followed by the development of robust
methods for characterizing and quantifying exposures to
humans and to organisms in the environment [5].
In 2009, NNI agencies reviewed the 2008 EHS Research
Strategy and the information and data in EHS and the
ethical, legal, and societal implications (ELSI) arena to
consider the best path forward for nanotechnology. The
2008 EHS Research Strategy document represented the
culmination of a comprehensive effort led by the Nanotechnology Environmental and Health Implications (NEHI)
Working Group under the National Science and Technology
Councils Nanoscale Science, Engineering, and Technology
(NSET) Subcommittee to provide guidance to the NNI Federal
agencies producing scientic information for risk management, regulatory decision-making, product use, research
planning, and public outreach. During this review, the 2009
nanotechnology EHS (nanoEHS) workshop series convened
experts from industry, academia, and the United States
Federal Government to share the latest information and
newest developments, the current state-of-the-science, and
research gaps in the nanotechnology-related EHS eld [6].
For example, the NNI 2010 Capstone workshop [7] concluded

2013 NNI R3 Workshop

Objectives
Top-Down Objectives
Decision Analysis

Identify stakeholder values and risk

Understand the state of practice
for the consideration of risk used by
industry, academia, and the general
public

Analyze the role of comparative

risk assessment in these evaluations,
including decision analysis tools and
gap analysis tools

perceptions that inform their decision

making, and opportunities to integrate
these values and perceptions into a
practical framework for risk
communication

Discuss current risk management

practices in the emerging technology
communities

Determine steps to improve the linkage of risk assessment to risk management

and risk communication

Bottom -Up Objectives

Risk Assessment

Figure 1

2013 NNI R3 workshop objectives.

that existing approaches to assess environmental risks of

nanomaterials or establish standards are data-intensive,
time-consuming, and expensive. Overall, the knowledge
gleaned from the nanoEHS workshop series was critical to
the development of the 2011 NNI EHS Research Strategy.
This strategy document identied important data needs
in the areas of nanomaterial measurement infrastructure,
risk assessment and management methods, human health,
the environment, informatics, and human exposure assessment.
As a follow up to the previously mentioned NNI EHS workshop series, the 2013 NNI nanoEHS stakeholder workshop1
was designed specically to facilitate discussion among
various stakeholders of approaches, tools, and methods
used to assess, manage, and communicate the potential risks of nanomaterials and nanotechnology-enabled
products [8] (see Fig. 1). Approximately two hundred participants engaged in the workshop, including over a hundred
participants on site and another hundred remotely. Participants included stakeholders from insurance companies,
industry, labor organizations, academia, government, nongovernmental organizations, and other members of the
public. Stakeholder communities emphasized the importance of sharing the right amount of information to support
top-down approaches for risk-based decisions on nanomaterials [9]. Participants discussed the importance of
providing sufcient information on nanomaterial-containing
products in safety data sheets in order to protect workers [10]. Input from the business community called for
the development of best practices for agencies to communicate with small businesses. For example, stakeholders

1 The NNI Stakeholder Perspectives on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology
workshop, September 1011, 2013.

8
suggested the creation of a repository of information (with
links to more in-depth information) that includes guidance
documents and other resources to aid the small business
community in making informed decisions when entering the nanotechnology market. Furthermore, participants
highlighted the importance of independent, third party
validation of data to facilitate risk-based decisions, especially regarding commercializing nanotechnology-enabled
platforms (the Nanotechnology Characterization Laboratory
is a good example of such efforts) [11]. Exposure assessment was also discussed as a priority research area for risk
characterization of engineered nanomaterials. Workshop
attendees ultimately recommended integration of hazard,
exposure, and effects data (including models) within the traditional risk assessment paradigm. This is to be coupled with
an understanding of stakeholder needs and a comparative
assessment of individual risk metrics through the product
life cycle using decision-analytical tools. Due to the complex nature of nanotechnologies, several requirements were
discussed such as techniques to quantify particles in vivo
and the release of particles from nanotechnologies. Finally,
the use of a life-cycle approach was described in several
examples to guide the characterization of releases.
Efforts to meet these data needs are ongoing, and a
signicant amount of new data on the toxicity potential
of nanomaterials is now available. The National Institute
of Occupational Safety and Health (NIOSH) continues to
issue Current Intelligence Bulletins to disseminate new scientic information about potential occupational hazards of
nanomaterials (for example, carbon nanotubes [12]). Global
efforts, including those of the OECD and other bodies [13],
have developed guidelines for improving the data quality
including recommendations for adequately characterizing
nanomaterials prior to toxicological studies and developing
robust, validated methods for characterizing and quantifying nanomaterials in experimental media, tissues, and cells.
Efforts in the private sector have also focused on the development of new methods to estimate commercial risk such
as the Zurichs Nanotechnology Exposure Protocol (ZNEP),
which analyzes material characteristics, manufacturing processes, relevant commercial applications, exposure control
measures, and the scientic and regulatory information to
create an individual risk rating [14].
New approaches for toxicity evaluation (such as highthroughput screening) have been identied as methods to
accelerate the development of data, as well as methods to share and evaluate the data produced in these
studies. These data-sharing methods include models to prioritize materials for further testing and evaluation, and
fully curated repositories (such as the Nanomaterial Registry
[15]) that archive research data on nanomaterials and their
biological and environmental implications to improve subsequent approaches to toxicity and exposure studies. Finally,
advances in metrology have resulted in new methods to
characterize releases of nanomaterials in the environmental media (e.g., air and water), transformation, and their
uptake into the body.
Discussion amongst meeting participants moved beyond
strategizing research needs for nanotechnology risk analysis
to focus more on the current tools and methods adopted
by non-Federal stakeholders in making risk-based decisions on nanomaterials. For example, the plenary session

T.R. Fadel et al.

featured perspectives from various communities on current
approaches for risk-based decisions. A non-governmental
representative discussed the use of a comprehensive systematic hazard screen method for nanomaterials (the Nanosilver
GreenScreenTM hazard level screening assessment of nanosilver and silver green [16]) and provided evidence that some
nanomaterials can be assessed for hazards, although specic data gaps still need to be lled. The International
Life Science Institute (ILSI) effort, Nanorelease, aims to
develop techniques to quantify release of particles from
a carbon nanotube composite and inform exposure assessment [17,18]. In the workplace environment, tools such as
the NIOSH Approaches to Safe Nanotechnology [19] and the
control banding Nanotool (for the critical evaluation of engineered nanomaterial safety data sheets) [20] were identied
as examples that facilitated risk assessment. Case studies
presented at the workshop used exposure characterization
information to develop best management practices to manage uncertain risks. Uncertainty in the assessment process
was often associated with a lack of standard methods or test
guidelines, limitations in analytical instruments, and the
inability to predict releases of a technology in early stages
of development. Industry stakeholders described a conservative approach for worker protection, where in situations
of limited data or standardized methods were unavailable,
then best management practices were instituted to ensure
worker safety.

Conclusion
Efforts to engage stakeholders in public venues such as
the 2013 NNI workshop on the Perception, Assessment,
and Management of the Potential Risks of Nanotechnology remain an essential tool to guide decision makers in
the responsible development of nanotechnologies. Several
important topics emerged from the workshop: the plenary
sessions, for example, emphasized the need for improved
risk management and communication processes throughout
the supply chain (e.g., the use of more complete safety
data sheets). Comparative risk assessment models were
also emphasized, as well as the need for repositories of
risk-based information on nanomaterials. Additional future
research areas included the development of tools and methods (including models) for accurately assessing exposure
and the potential risks of nanomaterials; improved data
quality for nanomaterials risk assessment; the research on
Engineering Design

Risk
Analysis

Informaon Integraon Needs

Life
Cycle
Analysis

Mul-Criteria Decision Analysis

Figure 2 Integration of risk and life cycle analyses to guide

engineering design using multi criteria decision analysis (after
[21]).

The challenges of nanotechnology risk management

categorizing nanomaterials to support risk assessment, and
the development of a regulatory framework for the safe
development of nano-enabled commercial products. Such
activities are necessary to help guide the next generations of
sustainable nano-enabled product designs and facilitate the
integration of life cycle and multi-criteria decision analyses
(Fig. 2).

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Dr. Tarek Fadel is a Staff Scientist at the
National Nanotechnology Coordination Ofce
and the Executive Secretary for the Nanoscale
Science, Engineering, and Technology (NSET)
Subcommittee of the White Houses National
Science and Technology Council (NSTC). Dr.
Fadel is also Vice-President for Research at
the International Technology Research Institute. He previously held positions as a Process
Engineer at LSI Logic, and Product and Systems Interaction Engineer at Hewlett Packard
Corp. Dr. Fadel holds chemical engineering degrees from Oregon State University and Yale University where he obtained a
doctorate in 2011. After graduation, he continued at Yale as a postdoctoral researcher developing nanoscale biomaterials for cancer
immunotherapy. Dr. Fadel is lead author in several peer-reviewed
publications in the elds of nanomedicine, cancer immunotherapy,
and biophysics. As a fellow for Yales Advanced Graduate Leadership Program, he acquired business and entrepreneurial experience
at the Yale School of Management. Dr. Fadel was the recipient of
the Yale Harding Bliss Prize presented annually to a graduate student who has done the most to further the intellectual life within
the School of Engineering & Applied Science.
Dr. Jeffery Steevens is a Senior Scientist at the U.S. Army Engineer Research
and Development Center (ERDC) in Vicksburg MS, USA. He received his Ph.D. from
the Department of Pharmacology and Toxicology at the University of Mississippi in 1999.
He currently provides the technical guidance
for the Armys Environmental Quality and
Installations Research Program. His research
interests include life cycle analysis, environmental risks of engineered nanomaterials,
and use of advanced materials for sensing and remediation.
Dr. Thomas is a toxicologist and leader of
the Chemical Hazards Program team in the
U.S. Consumer Product Safety Commissions
(CPSC) Ofce of Hazard Identication and
Reduction. His duties include establishing priorities and projects to identify and mitigate
potential health risks to consumers resulting
from chemical exposures during product use.
Dr. Thomas has conducted comprehensive
exposure assessment studies of chemicals in
consumer products and quantied the potential health risks to consumers exposed to these chemicals. Dr.
Thomas is responsible for developing agency activities and policy
for nanotechnology. Dr. Thomas has served as a CPSC representative
on a number of nanotechnology committees including the ILSI/HESI
Nanomaterial Environmental, Health, and Safety Subcommittee,
the Federal NSET and NEHI sub-committees, and the International
Council on Nanotechnology (ICON).

10

T.R. Fadel et al.

Dr. Igor Linkov is the Risk and Decision
Science Focus Area Lead with the U.S.
Army Engineer Research and Development
Center, and an Adjunct Professor of Engineering and Public Policy with Carnegie
Mellon University. He is working on integrating decision-analytical and risk analysis tools
to assess risk of emerging technologies and
threats. Dr. Linkov has served as an Army
representative on the National Nanotechnology Initiative NEHI sub-committee. He has

published widely on emerging technologies, modeling, policy and

risk analysis, including 14 books and over 200 peer-reviewed papers
and book chapters. He is the recipient of two Army medals for
outstanding civilian service. He is the recipient of the 2005 SRA
Chauncey Starr Award for exceptional contribution to Risk Analysis,
SRA Fellow award and was an elected SRA Councilor (20092013).