Development Ethical and Societal Issues Satyen Baindur PhD

OPRA Report 4-2006-1 

Stewardship in Nanotechnology 

Development: Ethical and Societal Issues 

Satyen Baindur, PhD 

Principal Researcher and Chief Scientist 

Ottawa Policy Research Associates, Inc. 


Report No. OPRA-2006-4-1 Issued April 2006

Stewardship in Nanotechnology Development: 

Ethical and Societal Issues 

SATYEN BAINDUR, PHD 


OPRA Report 2006-4-1 Issued April 2006 

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INTRODUCTION 

The science of matter at the nanoscale 1 has been rapidly advancing in the past 

decade. So also has the set of methods, techniques and approaches that enable the design, 

characterization and assembly of atoms, molecules, structures, devices and systems at the 

nanometer scale by controlling their shape, size, physico-chemical composition, surface 

characteristics, solubility or agglomeration properties. Collectively, these techniques and 

methods constitute nanotechnology; the plural ‘nanotechnologies’ is often cited, to 

emphasize that one is dealing here with general-purpose technologies that enhance and 

enable yet other technologies, influencing a very diverse set of application areas. 

At the most basic level, nanotechnologies result in new materials and device 

possibilities that exploit the unique physical and chemical properties of matter occurring 

at the nanoscale. These materials, generically called ‘nanomaterials’ 2 , come to have 

properties extending beyond those of materials found in nature. For example, some of 

these materials can have extreme hardness, or high tensile strength, but simultaneously be 

significantly lighter in weight than materials with similar properties found in nature. 

Other nanomaterials possess novel magnetic, electrical, optical or therapeutic properties 

that hold truly fascinating application potential. 

The field of nanotechnologies exhibits interdisciplinary convergence, where 

knowledge areas that were previously developing at their own pace, become thematically 

cohesive, and advance synergistically. Thus, one expects that the unprecedented pace at 

which nanotechnologies have been recently advancing will only increase in the future. 

While much that has happened in nanotechnologies is relatively new, it should not 

be assumed that all ‘nanotechnology’ is recent - in fact, there has long been an awareness 

of some of the special properties that result at the nanoscale, (though without knowledge 

of how they come about). For example, since medieval times, pigments used in stained 

glass have contained silver or gold particles in the 100 nm size range. More recently, 19 th 

1 The nanoscale has come to be defined as 1-100 nanometers, where a nanometer is one-billionth of a 

meter. 

2 There are many kinds of nanomaterials, and a taxonomy of such materials is now coming into being. A 

preliminary taxonomy is presented elsewhere in this document. 

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century scientists such as Faraday conducted experiments on gold nano-colloids 

(although that is not the term they used). Likewise, conventional industrial processes such 

as combustion, welding, friction, ablation, milling and pulverization have been producing 

nanosized particles unintentionally 3 for the past century or longer. Refinements of these 

techniques are now being used consciously to create what are titled ‘nano-alloys’, or 

more generically ‘nano-composites’. 

Not all nanoscale materials are anthropogenic. They are actually quite widely 

found in nature. Not only do proteins and enzymes behave as intrinsically nanoscale 

structures; but biological fluids such as milk or blood are nanoscale colloids, since they 

contain suspensions of nanoparticles, including proteins, lipids and fatty acids. Proteins, 

lipids and fatty acids, normally found in biological materials, are nanoscale molecules. 

For example, ferritin is an iron-storage protein occurring in the human body, with a size 

about 10 nm. Interestingly, from a clinical perspective, all drugs or pharmaceuticals 

(whether injected or ingested) pass through a nanoscale particulate phase before 

absorption by the human body. This perspective, which properly views nanoparticles as 

naturally occurring within the human body, is invaluable in properly situating the context 

within which the implications of nanomaterial interaction with the biotic and abiotic 

environments can be understood. 

Nanotechnology-based products that are now becoming commercially available 

involve nanoscale materials either as powders, aerosols, solutions, suspensions or 

colloids; or they are solid composite materials having a nanoscale structure. Product 

classes in which nanomaterials have been introduced or recognized include paints, 

cosmetics, pharmaceuticals, and textiles. Other product classes involving nanomaterials 

with diagnostic, imaging and therapeutic properties are still under active research and 

development. Occasionally, some products will be advertised by manufacturers as 

involving nanomaterials or nanotechnology simply to take advantage of the hype that 

3 

3 Particles with sizes less than 100nm i.e., 0.1 microns, have been traditionally called ‘ultrafine’ in contexts 

where production occurs unintentionally. However, ultrafine particles and nanoparticles have the same size 

range. 

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currently surrounds the ‘nano’ idea. For this reason, a careful examination of products 

claiming to use nanotechnology becomes necessary 4 . 

Not all the properties of nanoscale materials, however, are yet fully understood. 

The especially important issue of how nanomaterials will interact with the biotic and 

abiotic environment is still being actively investigated, and some preliminary results in 

are becoming available. Regulatory and policy interest in nanomaterials has, however, 

already been engaged in a proactive and forward-looking manner. 

As well, the possible risks from nanomaterials can be seen in the context of the 

known respiratory health risks of ultrafine particles (UFPs), fibres and filamentary 

materials, where the risk often arises, or is exacerbated, from the size and shape of the 

particles and fibres (especially when the size is in the nano range), and does not 

necessarily depend on the details of chemical composition. Since UFPs and nanoparticles 

(NPs) have the same size range, some of the same concerns are likely to apply to both. 

Furthermore, experience with materials such as asbestos fibres indicates that risk 

management strategies can and should be implemented even in the absence of complete 

characterization of the material. In this context, nanotechnology could take some lessons 

learned about risks and risk management strategies. 

For these reasons, nanotechnology has engaged the strong interest of policy 

makers, regulatory agencies and civil society organizations with a health and 

environmental risk emphasis. This interest has heightened in the past couple of years as 

investigations on the interaction of nanomaterials with the biotic and abiotic environment 

have been yielding interpretable results. 

In addition to purely health or environmental concerns, ethical precepts such as 

the principle of respect for human dignity; the principle of individual autonomy; the 

principle of justice and beneficence; the principle of freedom of research, belief and 

4 

4 On March 10 th 2006, the Woodrow Wilson Center in Washington DC released its nanoproducts inventory 

based on a web search. However, almost immediately, some products were discovered that might not 

actually belong. A cosmetics product company. 

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conscience; the principle of proportionality of response; and the precautionary principle, 

also deserve explicit acknowledgment in the development of policy in the 

nanotechnology context. 

Ethical and societal concerns in the nanotechnology context have been voiced by 

a variety of stakeholders such as civil society organizations, NGOs, government officials, 

academics, journalists, novelists, scientists, technologists and businessmen. These 

concerns have taken the form of questioning whether one or other of the traditional 

ethical and humanistic precepts might be sacrificed as nanotechnology develops, and 

whether sufficient thought has been devoted to the societal impacts that such 

development might create (as opposed to the merely health or environmental). Given the 

voicing of these concerns on the one hand, and the vast potential that others see in this 

technology on the other, the nanotechnology context today is suffused in an atmosphere 

of ‘hope, hype, risk and fear’. Hype can be characterized as an extreme manifestation of 

hope, and similarly, fear arises from an extreme risk perception. 

Since nanotechnologies span an extremely broad ambit of potential applications, 

it is not easy (or even possible) to fully anticipate the different social and ethical concerns 

that might arise as different nanotechnologies are developed. Two fundamental points 

deserve emphasis. One is that some ethical and societal concerns underlie all 

technologies, usually throughout the course of their development, and sometimes even 

after they have reached a ‘mature’ status. Often the societal or ethical concerns that were 

articulated when the technology was conceived (or, on occasion while the technologies 

are still being developed) are not the ones that are most salient when the technology has 

matured. The other is that the actual deployment and application of technologies is 

strongly influenced by a society’s broader priorities, and is not determined solely by what 

is feasible technologically – the applications are not automatic or technologically 

predetermined. 

Therefore, two conclusions follow. First, since ethical and societal concerns will 

arise throughout the lifetime of a technology, it is more important to have in place a 

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mechanism that enables such issues and concerns to be dealt with on an ongoing basis 

than to attempt to address them once and for all. Secondly, since social forces strongly 

shape a technology’s deployment trajectory, a simple extrapolation of technological 

capability or an obsession with the worst-case scenario usually leads to wrong 

conclusions. It is important to realize that mere technical feasibility of an application at 

this time will not by itself ensure widespread use in the future, while a sustained R&D 

effort together with significant cross-sector convergence, can generate technical 

breakthroughs that are impossible to predict. Thus what appears as extreme hype and 

extreme fear today could turn out wildly wrong, at either end. 

That said, developments in nanotechnology do in fact raise some profound 

questions about a number of very basic ethical issues, including: personal identity and 

privacy; security of information and safety of health; economic and social equity and 

equitable access to the potential benefits of nanotechnology, among many others. A 

number of these issues have arisen in the context of other technologies also, and the 

nanotechnology version of these issues differs only in its scope, the level of urgency and 

in its specific details. However, if someday the full convergence of nanotechnologies 

with other technologies does occur, then the nanotechnology version of the issues could 

very well subsume the others, because it possesses a greater, more profound scope. For 

this reason, an explicit exploration of the nanotechnology versions of the issues is 

necessary. 

To illustrate the point, consider the fact that issues dealing with (violation of) 

privacy, ease of economic access, societal impact, human capacity enhancement - each 

also have ‘biotechnology’ and Information-Communication-Technology (ICT) versions, 

in addition to a nanotechnology version. Each of these technologies has also raised the 

possibility of differential access – a ‘biodivide’, a digital divide, or a ‘nanodivide’. What 

is different about the nano versions of these issues is the possibility that convergence 

between the technologies might create a nano version that severely exacerbates their 

effect. What is also different is that, given the present status of nanotechnological 

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development, there is still time for these issues to be proactively identified and, perhaps 

even obviated, through anticipatory action. This document is devoted to a detailed 

consideration of some of the ethical and societal issues that underlie nanotechnology 

development. 

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The ‘Nature’ of Nanotechnology 

One strongly expressed concern deals with the very nature of nanotechnology 

itself, especially when contemplated in conjunction with biotechnology and information 

technology. It is often caricatured as the ‘gray goo’ scenario, in which a malevolent life 

form, developing from a self-assembling nanostructured system, is projected to go ‘wild’. 

This actually bears resemblance to some of the more sinister scenarios that had been 

imagined in the context of biotechnology and genetic engineering beginning about thirty 

years ago. 

Specific versions of the ‘gray goo’ scenario have been dismissed on the ground 

that they violate some physical laws such as conservation of matter and energy. However, 

at a fundamental level, the concern cannot be completely dismissed 5 . If life as we know it 

today is itself an example of ‘nanotechnology that works’ then a nanotechnology that 

works slightly differently can also be imagined. If autonomy and self-replication, 

followed by some form of adaptive behaviour, are considered as prerequisites for life, 

then efforts are certainly underway today to endow artificial nanosystems with some or 

all of these attributes 6 . In many ways these systems behave as artificial life forms, or at 

least, successful bio-nano hybrids. Some of these developments are taking place today 

under the rubric of ‘synthetic biology’. 

5 Indeed, some highly respected scientists and technologists have voiced similar concerns. For example, Joy 

(2000), and Drexler (1986) have contemplated such scenarios, with Joy (2000) also advocating a 

suspension of R&D in this area. 

6 Some demonstrations of auto-catalyzed in vitro self-replication, and nano-bio combinations that 

involve, for example, biological motors powering non-living objects – have also been demonstrated. For 

example, Montemagno & Bachand (1999), Soong et al (2000). Other attempts to manipulate DNA 

molecules with breathtaking precision, creating ‘DNA Origami’ have been described by Seeman (2005) 

and Rothemund (2006). In fact, DNA has already become the ‘scaffolding of choice’ for a number of nanoself-assembly 

applications, based on the ability to create such ‘DNA Origami’. 

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A precaution that has been suggested (e.g. in an editorial in Nature 7 ) is to 

engineer these new life forms in a way that they become nutritionally dependent on 

materials available only in the laboratory, but not in nature. In this way, it is hoped that 

the new life form would not be able to survive outside a laboratory. This is a sensible 

precaution but cannot be viewed as foolproof. 

A line of reasoning that attempts to criticize this concern about runaway nanolife 

forms – turns on the definition of ‘nano’ – it is asserted that viruses (the only autonomous 

biological entities that are smaller than 100nm in size and thus truly exist at the nano 

scale) – cannot reproduce without taking over the cellular machinery of another higher 

organism. Therefore, it is asserted that ‘not even nature’ has a truly self-reproducing 

organism at the nano scale. The subtext seems to be that the nanoscale cannot possibly 

embody the full complexity required to sustain self-organized self-reproducing processes. 

Yet this can be countered by realizing that a possible new nano life form could also learn 

to self-replicate by the same technique as viruses now do 8 , even if one grants that the full 

complexity of life processes cannot be reproduced at the nanoscale – though even that is 

not fully clear. That is, a new nanoscale life form could be intrinsically parasitic in its 

reproductive mechanism. This is not unlike a computer virus that is designed to take over 

its host computer’s disk space and operating system in order to reproduce. 

The other weakness of such an argument is a narrow focus on the definition of the 

nano scale – it is quite possible that a new nano-based life form could have a hierarchical 

organization. Just as cells are made of molecules in living things today, so a possible new 

nano-based life form could be based on nanoscale materials and then self-organize itself 

into its equivalent of (nano)biological cells. Thus, while an obsession with the worst-case 

scenario is not justified, an overly dismissive stance regarding concerns about the very 

nature of nanotechnology also does not appear warranted. In this context, even a modest, 

8 

7 Nature 24 November 2005. Similar precautions were suggested earlier by the Foresight Institute and also 

by the Center for Responsible Nanotechnology. 

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incremental change in technological terms, could lead to quite profound social impacts 

with ethical consequences. 

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Enhancement of Human Capacities 

This concern deals with how nanotechnology, in converging with biotechnology, 

information technology, and cognitive science – will some day transform the nature of 

life, and perhaps also, what it means to be human 9 . At the simplest level, for example, 

retinal or cochlear implants, which are already available today in some versions, enable 

significant enhancement to the life possibilities of the visually and aurally impaired. As 

nanotechnologies develop further, capabilities such as these, along with memory, height, 

intelligence, physical performance, and similar ‘intrinsic’ human characteristics, could 

also be enhanced from some bio-nano convergent product. Two kinds of ethical issues 

arise here – one is about the ability to access such interventions, and how it would be 

rationed when access cannot be equitably ensured. The other is about the desirability of 

the enhancement itself. 

Also, the dividing line between ‘therapy’ and ‘enhancement’ may not always be 

clear. Often, it will be the innovations that result from research into therapeutic 

possibilities that will provide the knowledge base to enable enhancement. Of course, the 

issue of enhancement of human capacities has arisen within the pure biotech context as 

well, and some kinds of enhancement, such as those in enhancing muscular development 

through use of insulin-growth-factor (mIGF-1, the genes for which have been identified 

and cloned, and gene transmission therapies developed and tested in mice 10 ) have already 

been enabled by the new genetic biotechnology even without an explicit nano 

component. 

9 Although enhancement has received most attention, it is also possible to envisage similar technologies 

which can reduce human capacities, so the concern may be more properly titled ‘human capacity 

transformation’. 

10 1. Barton-Davis, E., et al., “Viral mediated expression of insulin-like growth factor I blocks the agingrelated 

loss of skeletal muscle function,” Proceedings of the National Academy of Sciences 95: 15603- 

15607, 1998. 

2. Musaro, A., et al., “Localized IGF-1 transgene expression sustains enlargement and regeneration in 

senescent skeletal muscle,” Nature Genetics 27: 195-200, 2001. 

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The enhancement to human capacities that may result from nanotechnology will 

probably not happen all at once; a steady progress in that direction appears more likely. 

However, even incremental technological progress can lead to dramatic social and ethical 

issues coming to the fore. Ethical issues such as how equitable access to these kinds of 

interventions will be ensured will then become especially salient. Though similar issues 

about access are present in different health care settings today, they largely revolve 

around access to therapies. It is likely that when enhancements do become available, they 

might initially look a lot like therapeutic advances, introducing another complication. The 

other major ethical issue that will arise in the context of enhancements is the definition of 

what it means to be human, and a significant impediment in resolving this would be 

conceptually distinguishing: 1) enhancements that arise from evolutionary forces and 2) 

enhancements that arise through technology. Since technology is itself a product of the 

human mind, some will argue that the two kinds of enhancements lie on a continuum, 

while others will see a disjuncture. 

As an example, reversal of blindness from age-related macular degeneration (if 

successful) may be seen as therapeutic, but a reversal of congenital blindness, although it 

may be perceived as ethically correct - could be seen as an enhancement, especially if 

carried out in later life. Extending the example, it is conceivable that developments in 

nanotechnology would someday allow vision to be extended to the infrared spectrum, 

enabling natural night vision. However, since deterioration of night vision is also agerelated, 

the initial beneficiaries might be older people, who will likely see it as a 

therapeutic advance. A virtually identical product, or even the same product, might, 

however, provide an enhancement to younger people with ‘normal’ human night vision. 

Such developments will introduce complex new regulatory and ethical issues. Some of 

these types of issues have begun to come up already in the context of gene therapy, 

where the boundary between therapeutic advances and enhancement is no longer clearcut. 

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As a more complex, convergent process, at the socio-econo-bio-info-cogno-nano 

level, there is also the possibility that a fundamentally new life form could come into 

existence in the future. This could happen through an incremental enhancement of 

human capacities (for example, a progressive substitution of prostheses for diseased or 

incapacitated organs, or organ regeneration, or a networking of biological instrumentation 

with human organs, or an interfacing of human sensory organs with computers). Or it 

could happen through an unforeseeable combination of the bio and nano components 

spontaneously acquiring the attributes of locomotion, autonomy, adaptation, and autocatalyzed 

self-replication. A version of the latter possibility has been present ever since 

recombinant genetic technology came on the scene thirty years ago, but at least any new 

life forms were then expected to still be DNA-based. In the years since such concerns 

were first voiced, developments in the biotech field have included, among others: 

cloning, genetically modified organisms, transgenic organisms and even the 

possibility of chimeras, but of course, all of these were, or have been, DNA based. 

Another possibility, leading logically from the combination of enhancement of 

human capacities and the possibility of new life forms, is the prospect of eventual 

prolongation of life, perhaps in perpetuity 11 . Since mortality is one of the more widely 

accepted characteristics of human (and all other living) beings, this prospect, combined 

with the issue of access to the interventions that might make it achievable, is likely to 

raise some of the most profound ethical issues of all. 

While it is certainly possible that the scope of nanotechnology in these matters 

may turn out to be no greater than that of biotechnology, the possibility also exists for 

qualitatively new developments, and stakeholders should therefore maintain awareness, 

foresight and analysis capacities with respect to developments in the field. 

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11 This does not appear imminent at the present time, but is logical to raise in a forward-looking issues 

discussion. The possibility is not just that human beings might simply live longer in their own bodies, but 

it could also take the form of continual organ regeneration, or humans interfacing with electronic 

equipment to form new entities. It could also take the form of downloading one’s experiences into software 

life forms, so that life continues in software etc. 

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Determination of R&D Priorities: A Nanodivide? 

Another recurring concern deals with how research & development priorities as 

regards nanotechnology will be decided and how the benefits from nanotechnology, 

especially bionanotechnology (or medical applications of nanotechnology) will be 

distributed across people with different needs and abilities to pay. (To invent a 

hypothetical, but not unrealistic example, consider a tissue regeneration process that 

becomes commercialized using bio-nano-genomic convergent technologies, and enables, 

for example, reversal of blindness caused by macular degeneration. Initially, the cost of 

accessing the procedure is likely to be quite high.) 

Yet such concerns are already present today , and manifest themselves in different 

health care settings. They are also present in the concern over the ‘digital divide’ – the 

perception and reality of differential access to the benefits of information & 

communication technologies by social and economic class, between, among and within 

nations. Thus, at its core, this type of concern, when expressed about nanotechnology, is 

really a concern about the transparency and democracy of funding decisions, and not 

about the nature of nanotechnology itself. However, the opportunity does exist in the 

nanotechnology context today to address some of these concerns in a distinctive way, by 

promoting the greatest possible transparency, encouraging inclusive dialogue and wideranging 

consultations with a variety of stakeholders, and using their input in the policymaking 

process. 

This is true within a country, as well as across the international community as a 

whole. To put this in broader context, consider that nanotechnology has been envisaged 

to hold the promise of meeting a number of the Millennium Development Goals adopted 

by the United Nations in the late 1990s. Among these goals include the eradication or 

substantial reduction in the incidence of malaria, tuberculosis, blindness, HIV incidence, 

child poverty and hunger; the provision of safe drinking water; shelter and clothing for 

the populations of the poorest parts of the developing world, especially in sub-Saharan 

Africa. 

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It is important to point out that while the ‘digital divide’ and the ‘biotechnology 

divide’ have had a significant ‘North-South’ component, there are indications that the 

‘nanodivide’, if it does come about, may well also have more of a South-South character. 

This is to say that some of the major countries of the global South, including India, 

China, Brazil and South Africa, are moving ahead with broad national initiatives in 

nanotechnology, while countries like Korea and Singapore may already be on par with 

countries of the North in their nanotechnology development. The vast majority of other 

countries, however, including most of sub-Saharan Africa, are currently significantly 

behind the rest of the world in nanotechnology awareness. Under such conditions, the 

divide between countries of the South may be just as large, or even larger than that 

between countries of the North and some of the advanced countries of the South. 

Two aspects of any possible future ‘nanodivide’ deserve mention. First, if the 

R&D priorities pursued in the North and the South diverge, because of differences in 

demographics; consumer tastes; health needs or economic imperatives – then significant 

sanitation, public health, water availability, and food needs of developing countries may 

well go unaddressed, because of a lack of R&D capacity in the South. The second issue is 

that a possible future ‘nanodivide’ is likely to exacerbate existing differences in 

individual and population health attainment between countries of the global North and the 

South. In an increasingly globalizing world, this will become ethically intolerable, and 

moreover, will increase vulnerability in the global North to catastrophic health care 

emergencies that arise from developments in the global South 12 . Thus a proactive stance 

will build in foresight and policy analysis capacities with respect to such exigencies. 

Of course, a possible ‘nanodivide’ could occur within 

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nations too, 

disproportionately impacting certain traditionally marginalized communities within the 

North.. Analysis of mechanisms to ensure access and delivery of health benefits from 

12 This is even more the case if human enhancement, discussed in the previous section, were to become 

routinely available through nanotechnology, and remain restricted to people living in the advanced nations 

because of a ‘nanodivide’. Should this happen, it is quite possible that the enhanced and natural humans 

would have different susceptibilities and vulnerabilities to diseases. 

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nanotechnology to such communities is a significant issue to be borne in mind as the 

health benefits of nanotechnology develop. 

Intellectual Property Regime 

If the benefits of nanotechnology must be more widely dispersed, and in an 

equitable and humane fashion, then one must also examine the intellectual property (IP) 

regime, which grants legal rights that result from intellectual activity in the 

nanotechnology arena. IP rights take the form of patents, copyrights, industrial designs, 

or rights to integrated circuit topographies, and which may extend in the future to 

nanotechnology as manufacturing process descriptions, pharmaceutical particle size 

distributions, alloying procedures and the like. Such IP rights underlie the very process of 

commercialization of technologies, and a vibrant intellectual property regime is 

considered a critical part of any innovation process. The exclusivity offered by a patent, 

for example, can be decisive in recouping the high level of investment required both for 

the foundational research and in the commercialization of the resulting product. Also, for 

a start-up company, the nature of the IP and the patent holdings in particular, validate for 

an investor the soundness of the basic technology and the business model. 

While patent rights are critical to deriving commercial value from technical 

innovations, an overly broad interpretation of the possible applications from a given 

invention, as might be claimed in a patent, can also serve to restrict other innovations. In 

many contemporary industries today, including materials, biotechnology and ICT, the IP 

regime has tended to create a patent thicket: an overlapping set of patents that forces 

innovators seeking to commercialize new technology to obtain licenses from incumbent 

multiple patent holders. Some of these patents are held by companies; individuals and IP 

traders who may never intend to commercialize the idea behind the patent. In many cases, 

the intention is precisely to create such a thicket, by filing patent claims in several tightly 

related areas (‘predatory inventors’). 

Generally, patent granting authorities [in the US, the United States Patent and 

Trademark Office (USPTO)] will weed out patents with overly broad claims. However, 

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broad patent claims can be granted for “pioneering” inventions, which involve a 

breakthrough that opens a whole new field. For example, it may be claimed that the 

process for making carbon nanotubes, discovered in the early 1990’s, was one such. On 

the other hand, “improvement” inventions are usually not granted such broad claims. An 

example of an “improvement” invention is a batch of purified nanotubes having a certain 

ratio of semiconducting to conducting (i.e., metallic) nanotubes. 

The nanotechnology field is also distinctive as far as IP rights are concerned, in 

that, given the many different possible applications for a specific nanotechnology 

innovation; the claims of patent applications have often tended to be quite broad. There is 

therefore a perception in the nanotech community that “patent thickets” may have 

developed in some nanotech sectors. 

A case in point that is particularly relevant to cancer nanotechnology may derive 

from the fact that quantum dot patents are largely held by photonics and electronics 

companies, while dendrimer patents are held largely by pharmaceutical and cosmetics 

companies. Thus innovators developing a product involving both might very well have to 

negotiate a patent thicket with multiple patent holders. Therefore an important set of 

issues in the field of nanotech IP arise from the need to prevent the development of patent 

thickets, and to factor in the interdisciplinary and convergent nature of nanotechnology to 

weed out overly broad individual patent claims as well. 

Other issues that arise in related areas include those dealing with the definitional 

characteristics of nano- and nanobiotechnology, both for patent granting purposes and for 

regulatory purposes. Here the physics-based definition of 1-100nm size range will not 

suffice 13 , and may even tend to inhibit legitimate patent filings on the one hand, as well 

as encourage trivial filings on the other. For example, merely bringing a previously 

existing product into the nanosize range is considered patentable by some and not by 

others - this is a relevant issue to settle. The characterization of nanomaterials, both in 

general and in the context of specific health-related applications is an important step 

13 Note that the Greek word ‘nano’ means ‘dwarf’ or ‘very small’, and this is the sense in which the term is 

likely to be used as a prefix outside the strict physics context. 

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prior to clinical trials and subsequent submission for regulatory approval. In the US, the 

National Cancer Institute has specifically established a Nanotechnology Characterization 

Laboratory tasked with carrying out pre-clinical testing and characterization of 

nanotechnology-related cancer treatments. Such a characterization facility would 

interface with both intellectual property offices and with regulatory approval 

mechanisms. It would also have to coordinate with standards setting and metrology 

institutions 14 . 

The academic background of patent examiners, and whether it includes sufficient 

inter-disciplinary focus, both to recognize and discourage overly broad patent claims on 

the one hand, and encourage truly novel applications on the other, is another relevant 

issue. A related issue deals with standards setting, measurement, and verification of 

nanoparticle and nanomaterial related claims. This capacity is critical to patent granting, 

regulatory approval, and to health and safety evaluation. In the health and safety context, 

moreover, the related issue of dose metrics is relevant in estimating the exposure to 

nanomaterials, and can be acted on only when there are widely accepted measurement 

standards. The importance of standards and verification is greater in the nanomaterial 

context because many of their properties appear strongly dependent on the physicochemical 

environment in which they find themselves. This fact has actually impeded 

reproducibility and verification of research results even in a purely academic context, and 

the issue is likely to be even more critical in the commercialization context. 

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14 Specifically, the Nanotechnology Characterization Laboratory (NCL) at the US National Cancer Institute 

is tasked with developing and performing ‘an analytical cascade’ that tests the pre-clinical toxicology, 

pharmacology and efficacy of nanoparticles and devices (US NCL Business Plan, 2006), and interfaces 

with all potential application streams in health, safety and manufacturing. 

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Privacy and Security of Identity 

Another significant concern that has been expressed deals with the impact 

nanotechnology may have on remote sensing and surveillance technologies, and whether 

these might be able to violate individual privacy, or even to render the concept of privacy 

meaningless or severely compromised. This is even more the case when the potential of 

nano is seen in the context of bio and info technologies, and by visualizing their 

convergence. To an extent, the fear is driven by the hype about nanotechnology. For 

example, it is conjectured that nanosensors could someday come to exist in dimensions 

small enough to be obtainable in spray paint used in the walls of a house, a car or 

appliances. It is conjectured also that nanosensors could be autonomous, not unlike 

viruses or bacteria, and swarms of such sensors could form an undetectable monitoring 

network. 

While the fear is driven by the hype, not all such possibilities can be completely 

dismissed. It is in fact quite possible that developments in nanotechnology may enable, 

enhance or reinforce trends that are already under way in compromising individual 

privacy. For example, nanotechnology may very well enable extremely tiny Radio 

Frequency ID (RFID) tags to be attached to consumer products, and allow the linking of 

personal information to a particular purchased product, which may then allow individuals 

to be profiled and tracked when they visit a store. This could lead to increased collection 

of data on individuals; and it may occur without consumers being aware of the sensing 

devices. The RFID technology already exists, and nanotechnology developments could 

make the sensors less detectable, more sensitive, more mobile and more autonomous. 

The RFID technology can also lead to a subdermally implantable RFID device, 

which would unambiguously identify a person, and could in addition serve as a sensor for 

various health conditions that may well be monitored in real time 15 . It is also not too 

difficult to envisage a situation where this RFID device could be implanted without the 

explicit consent of the individual, or where informed consent cannot be given because of 

18 

15 Indeed, experimental demonstrations have already been reported, both in the US and in the EU. 

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the health status of the individual in question 16 , or where it could be programmed to 

monitor conditions different from those that were consented to. 

This type of technology could also be used to detect and store the detailed health 

state of an individual – for example, it is not too far-fetched to imagine a mobile (but 

passive) nano-biosensor network that detects individuals with specific health conditions, 

unbeknown to the individuals themselves. Clearly this would render the concept of 

individual health privacy completely meaningless. By only a slightly greater stretch of 

imagination, it is possible to envisage an active network of nano-biosensors that can 

invasively interrogate the health condition of a person or even a population, again without 

the individual or population becoming aware that this is happening. 

Of course, this type of innovation, should it come about, can also have beneficial 

public health impacts, and the violation of privacy must be balanced against the possible 

public health benefit. To some extent, this type of dilemma is already faced in the public 

health context today. The more significant concern is when the benefit from such a 

monitoring and surveillance is appropriated for exclusive private or commercial gain. In 

such a case, privacy will have been violated without a concomitant public benefit. 

A related concern is already being faced in certain biotechnology contexts, where 

it is now possible to detect certain heritable conditions or predispositions well in advance 

of when they manifest themselves. So long as the condition is not immediately life 

threatening, the detection of such tendencies is now considered subject to privacy laws, 

and even the affected individual may elect not to be informed, under a supposed ‘right 

not to know’. Storage of such information, when the individual has elected not to be 

informed, raises ethical issues, and widely accepted norms have not yet been established. 

A similar set of ethical issues underlies the development of such capabilities in the nano 

and bio-nano contexts, and an acceptable set of norms needs to be evolved. 

19 

16 For example, it has been suggested that such tagging could simplify identification of mentally 

incompetent individuals, or those suffering from conditions such as epilepsy, or those who might be unable 

to provide a complete health history, etc. 

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Nanotechnology is therefore not unique in giving rise to concerns regarding 

privacy; similar concerns having arisen before in the context of other technologies. Both 

biotechnology and information & communication technologies gave rise to similar 

concerns, and that continues to be a concern in respect of how both technologies are 

evolving today. The fear is greater when these technologies are foreseen to converge, and 

most of the concerns arise from simple extrapolation of technological possibilities. While 

the technological possibilities cannot be dismissed out of hand, the actual realization of 

the possibilities is a social process. Therefore the appropriate way to address such 

concern is also through social processes, including consultation, dialogue, democratic 

inclusion and transparency in decisionmaking, combined with a forward-looking policy 

framework and an informed policymaking mechanism. 

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Economic Impact 

Another oft-expressed concern deals with the impact nanotechnologies might 

have on the economic system, and the labour market in particular. This type of concern – 

which is finding voice in the context of nanotechnology today, also attended the arrival of 

earlier technologies such as the steam engine, electricity and atomic energy. Many of 

these concerns are also expressed under the assumed premise that technological 

development and deployment is an unstoppable juggernaut, proceeding with its own 

logic, unmediated by social or ethical concerns – a view that may be called ‘technological 

determinism’. 

The lesson from the past is not that the manner in which technologies such as 

atomic energy developed was uniformly benign and that there was no reason for concern 

whatsoever. Rather, the lesson is that the most significant concerns that did manifest 

themselves were not the ones that had been anticipated, and that technology and society 

interacted subsequently in interesting and subtle ways both to constrain development of 

the technologies and to advance them along unforeseen directions. For example, atomic 

energy was initially projected as becoming all pervasive, with devices from planes to 

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trains to automobiles and even toasters being atomic-powered. It was also projected to 

become so cheap that it would not need to be metered. Some of these possibilities were 

not realized because they proved technically infeasible. Others could not be 

commercialized because of a variety of reasons. 

There are some similarities in the projections made about nanotechnology today, 

in the pervasiveness that is held out for nanotechnology, and also in the oft-repeated 

assertion that the nanoscale is the most basic length scale at which all interesting 

phenomena occur, and that ‘biology, chemistry and physics’ all come together at this 

scale. It is further claimed by some that therefore, nanotechnologies will also 

revolutionize science education by properly emphasizing the importance of the 

nanoscale, doing away with traditional distinctions between scientific disciplines. While 

there may be a grain of truth in this, such assertions mostly just add to the hype 

surrounding nanotechnology today, since similar things were one said about atomic 

science, space science or computer science. 

That said, it is undoubtedly true that future development of nanotechnology will 

likely lead to a decline in employment in some sectors of the economy, that others might 

operate with different raw materials or use them less intensively, and some entirely new 

sectors will also evolve. This has happened with virtually all technologies. Seen in this 

light, nanotechnologies would be different from other technologies only in the details of 

which sectors and skills are impacted. This assertion is, however, somewhat weakened if 

it is realized that nanotechnology is explicitly conceived today as a transformative 

technology designed to change the basic dynamics of all economic sectors. By contrast, 

the Internet, when conceived, was designed merely as an emergency communication 

medium. That it has had a much broader impact today, simply underlines the fact that 

long-term techno-socio-economic projections have significant uncertainties. For this 

reason, even though the stated aim of nanotechnology is to impact all sectors, it may 

prove to be less than that – or it may prove to be far more than even its strongest 

supporters envision today. 

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In the international context, a concern that has been expressed is that 

commercialization of nanotechnology might lead to loss of markets for traditional raw 

materials, both primary – such as coal or iron ore; and agricultural, such as cotton or silk 

– that countries of the global South currently rely upon for export revenue. The loss of 

such markets may lead to further impoverishment of the global South, and thus further 

depress health conditions in these countries. Such a situation would further exacerbate 

any ‘nanodivide’ that comes to exist, and this is an especially grave ethical concern in 

sub-Saharan Africa. 

Thus in an enlightened stance, one would maintain awareness of such issues. It is 

necessary also to keep in mind the time scale over which such issues could arise, if at all. 

Significant economic impacts from most technologies are usually seen over a period of 

decades. However, there is the view that nanotechnologies might lead to compressed 

technological development time (a steeper S-curve), and this may well be true, or become 

true, for some nanotechnologies. 

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Bio-Nano Combination Products 

While regulatory and policy interest exists for applications and products involving 

nanomaterials across the board, interest is especially high in healthcare and biomedical 

applications. A particularly salient issue in the context of biomedical nanotechnology is 

that some products are turning out to span traditionally defined product classes. The 

potential of nanotechnology, in convergence with biotechnology and information 

technology gives rise to such possibilities. 

For example, some nanotechnology-based products can be simultaneously 

medical devices, as well as pharmaceuticals, and some may in addition include 

biologically active species. These have come to be called ‘combination products’, and 

some jurisdictions have begun to address their regulation issues based on the primary 

mode of action, defined as the most important therapeutic effect; the combined action of 

all modes being necessary for the full impact of the product (US FDA 2005). 

Combination products are made of multiple constituents: drug-device, drugbiologic, 

device-biologic or drug-device-biologic; that are physically or chemically 

combined, co-packaged in a kit, or separately cross-labeled products. All components 

work as a system and are critical to achieve the desired therapeutic effect. 

An example in the context of nano-oncology (‘cancer nanotechnology’) would be 

a drug-device-biological combination as follows (this is a hypothetical but realistic 

example): 

• A nanotube based microfluidic drug delivery device 

• A therapeutic agent carried within the nanotube (drug) 

• A quantum dot based imaging device 

• A low-density-lipoprotein or oligonucleotide-based targeting agent 

(biological) 

All of these could conceivably be packed into the same drug-biological-device 

combination. Should such a device be developed, for example, it could be useful in both 

therapy and image assisted surgery for a metastasizing tumour. In this case, there are 

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actually two devices – the delivery device and the imaging device – in the same product. 

While the combination requires all of the components to achieve its effect, it is possible 

to argue that it be seen primarily as a therapeutic agent (depending, of course, on the 

treatment actually being implemented), with the delivery device, the imaging device, and 

the targeting agent being seen as subsidiary. However, in general, determinations of the 

primary mode of action are unlikely to be straightforward, and will undoubtedly 

introduce interesting issues and challenges in the future regulatory and approval context. 

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Towards a Definition of Nanotechnology 

The definition most often used today in the context of nanotechnology derives 

from an earlier definition of nanoparticle or nanostructure, based on a length scale of 

between 1-100nm. This, in turn, was derived from a definition that became common in 

the context of basic physics research in materials science and condensed matter during 

the 1990s. However, such a narrowly based definition is unlikely to prove adequate in the 

context of regulation of nanotechnology-based products, whether from a health and safety 

perspective; or a therapeutic, diagnostic, imaging or restorative standpoint. 

Efforts are active at this time, to arrive at a common agreement across 

jurisdictions on such a definition, coordinated both by organizations such as the OECD, 

ISO 17 and nanotechnology-specific organizations such as the International Council on 

Nanotechnology. 

The regulatory predicament is two-fold. First, there is the issue of analyzing and 

certifying the diagnostic or therapeutic claims of nanotechnology-based health-care 

products, and coming up with specific regulatory mechanisms and testing protocols. The 

second issue is the question of analyzing nanotechnology products in general from the 

health and safety standpoint. In the first case, manufacturers may well wish to attribute 

any therapeutic or beneficial property to a presumed ‘nano’-effect, and in the second, 

may well understate any ‘nano’-based effect. 

Within the therapeutic context, for example, nanotechnology based drug products 

are likely to be characterized by some or all of the following attributes, which may need 

to be explicitly introduced into regulatory considerations involving nanopharmaceuticals: 

a. Average particle size and size distribution 18 . 

b. Surface characteristics including area per unit mass, the presence of surface structure 

– e.g., dendrites on drug particles, and surface chemistry in general. 

c. For some applications, porosity of the particles may also be a relevant consideration. 

25 

17 International Standards Organization. 

18 Abraxane, a breast cancer drug, for example, has a mean particle size of 130nm. 

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d. For other applications, the hydrophilicity and surface charge density could be 

relevant. 

e. As for most other drug formulations, the purity, sterility and stability will also be a 

relevant characteristic of nanoparticle drugs, and as with other kinds of drugs, it will be 

necessary to determine if the therapeutic action in vitro is also valid in vivo. Since 

nanomaterials often display properties that are strongly dependent on their environment, 

the last consideration is more significant in the nanomaterial context than for other 

pharmaceuticals, whose action may be less sensitive to the details of their physicochemical 

environment. 

Such considerations thus go beyond mere particle size, and moreover, given the 

possibility of ‘combination products’ as mentioned above, regulatory considerations and 

definitions are likely to be appropriately more complex and nuanced, especially when 

they begin to involve biologicals and biotechnology products in addition to 

nanotechnology. 

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Building Regulatory Expertise 

Currently, the entire paradigm governing regulatory approval of health-related 

products on the one hand, as well as the safety and environmental health considerations 

regarding general consumer products on the other hand, is based on a biological and 

chemical disciplinary background. The assays and protocols required to secure regulatory 

approval are largely determined in terms of chemistry. As biotechnology, and in 

particular, proteomics and genomics have developed, some of the protocols have evolved 

beyond mere chemistry, to involve combinatorial and computer science oriented issues in 

addition. 

However, nanotechnology holds the promise of combining materials science with 

biology in ways unlikely to have been seen by most regulators before, and it will likely 

be necessary to require some supplementation of physical science concepts in their 

disciplinary backgrounds, as well as in the overall disciplinary orientation of the 

regulatory and approval regime. The educational backgrounds of the Health Physicists of 

today – who primarily deal with safety issues surrounding radioactive materials – has 

more of the balance between biology and physics, of the type that is likely to be needed 

in the case of nanomaterials. However, their training is oriented primarily to the health 

effects of radiation, and the different types and amounts of radioactivity to be expected 

from different types of sources 19 . The educational backgrounds of future regulators for 

nanotechnology will need to have components of materials science (‘nanoscience’) 

where Health Physicists have nuclear science, and knowledge of the emerging 

nanotoxicology, where Health Physicists have knowledge of radiation effects. 

27 

19 Radioactivity is not a principal concern in the context of nanomaterials – though certain kinds of 

radioactive dusts could have particles in the nanoscale range. Some concepts in radio-aerosol science and 

radioactive material safety are likely, however, also to have relevance in Nanomaterial Health & Safety 

Issues. 

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Building Risk Assessment R&D Capacity 

Of course, one of the major expressed concerns regarding nanotechnology deals 

with their health and environmental effects. Such concerns also originate from an ethical 

and societal perspective, and not exclusively from a clinical, medical, or techno-scientific 

perspective. This issue can be addressed by initiating multidisciplinary research programs 

into the health and safety aspects of nanomaterials. Designing such a research program to 

have significant and ongoing input from social scientists and ethicists, and creating a 

horizontally integrated research agenda – addresses it more fully. 

Such a research agenda would have a pharmacological, a toxicological and an 

ecological component, properly addressing issues that traverse disciplinary boundaries, 

and balanced by ethical and social perspectives. Risk assessment would include 

continuing and ongoing research into both exposure aspects and hazard aspects. 

As the pace of nanotechnology product development increases, and 

commercialization becomes a reality for many product classes, the issue of risk 

assessment is no longer merely of long-term interest, but can become critical and 

urgent. In Germany, for example, the National Institute of Risk Assessment issued a 

health warning in March 2006, against using a cleaning substance made from nanoscale 

materials that caused respiratory illnesses among users, particularly those who used the 

product in small, enclosed spaces. The product was subsequently recalled by the 

manufacturer. 

A related issue that arises in situations involving nanoscale materials in products 

is whether the earlier classification of products into 1) those that require regulatory 

approval prior to use, and 2) those that are subject to post-market surveillance – may 

need to be revisited as regards nano-products. Since nanomaterials have raised concerns 

about health and safety (discussed in detail elsewhere in this document), until greater 

information becomes available regarding the safety of nano-scale products in everyday 

use, one possible policy option is greater scrutiny for all nanoproducts before they reach 

the market, even if the product class to which they belong was previously not subject to 

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such scrutiny. Such risk assessment and precautionary action is made more credible only 

in conjunction with simultaneous building up of measurement, standards and 

characterization capacities, as was discussed earlier in this document. (This is also likely 

to have the effect of weeding out products that claim to have nanoscale materials but 

actually don’t.) 

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CONCLUSION 

To distinguish among different types of concerns outlined here, and to develop a 

coherent conceptual scheme to prioritize them, one could use the time scale over which 

the scenario underlying the concern manifests itself. For example, the concern about 

potential health and safety risks from nanomaterials is an immediate or near-term 

concern. It is manifest here and now. This is not to say that some health effects from 

nanotechnology may not appear a significant time after exposure. It is simply to assert 

that the concern is already with us, somewhat independently of the extent to which 

product development in nanotechnology advances. Of course, over time, the concern may 

change in intensity. Given that it is already present, however, action – in the form of 

research into health and environmental effects; and precaution, in terms of lessons 

learned from the past, seem quite warranted. 

While technological determinism is not the correct paradigm for thinking about 

the future, some real surprizes (both pleasant and not so pleasant) probably do await us in 

the products and services, and the economic and social changes that nanotechnology 

enables, facilitates or causes. There are alternatives to a deterministic view of 

technological development: for example, a socio-technological process in which social 

goals drive research, with society determining its needs early in the process, while 

technologists set technology targets and basic science is directed to meet those 

technological targets has been suggested. This perspective places the setting of social and 

ethical goals at the beginning of the technological process, not analyzing the impact at the 

end of the process. Also, science does not proceed ‘unfettered’ in this view; rather it is 

directed toward specific ends that have been determined beforehand. A slight 

modification visualizes an iterative process, with social and ethical considerations being 

determined on a continuous basis, with a stakeholder process being set in place, 

collaborations with natural scientists and technologists, and an ongoing evaluation 

process (Gorman 2004). A policy and foresight structure for nanotechnology 

development could be built around such a framework. 

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In addition to having an appropriate policy structure, there is also a need to 

initiate and promote inclusive dialogues regarding nanotechnology at all levels; to ensure 

that all stakeholders are respectfully heard; and that all concerns are voiced and 

acknowledged. 

In this way, policymaking proceeds with the greatest degree of 

awareness, and enables the creation of the greatest public good, while stakeholder 

interests are also appropriately represented. In addition, the ability to act transparently 

when enough evidence is adduced to motivate a particular course of action also enhances 

the credibility of the policymaking process across all stakeholder classes. 

Finally, but importantly, ethical and societal issues can only be dealt with when 

the knowledge base necessary to think through the issues is nurtured and strengthened. 

Just as the concerns over biotechnology gave rise to the academic discipline of bioethics, 

which built upon the existing discipline of medical ethics, a new discipline called 

‘nanoethics’ may very well need to come into existence. This discipline would build on 

traditions in bioethics, among other areas of inquiry, and would consider and incorporate 

basic ethical principles, both into policies regarding nanotechnology development, as well 

as in various application contexts for nanotechnology. Such a discipline would thus be 

able to address ethical issues that surround both the desirability for certain 

nanotechnology applications to move forward in the first place, as well as issues that 

arise after certain applications have already developed – such as equitable access and 

socio-economic impact. 

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32 

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Development Ethical and Societal Issues Satyen Baindur PhD

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