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Report compiled by the Economic Research Unit, INSCX exchange, November 2010
Submissions compiled by the
Economic Research Unit,
Integrated Nano-Science &
Commodity Exchange (INSCX exchange), United Kingdom
Note: A summary introduction to this report compiled by the Emerging Risk Special Interests section of Lloyds of London is restricted to Managing Agents and members of Lloyds of London.
Provided by Professor Jeremy Ramsden,
Chair of Nanotechnology,
Nanotechnology only emerged as a definable entity within the last decade, although its roots go back much further. Now it seems to stand at the threshold of progressing from a collection of laboratory curiosities (such as graphene prepared by pulling sticky tape off graphite) and exotic and exclusive consumer items (such as Roger Federer's tennis racquet) to commodities that are now being manufactured on an industrial scale (such as fullerenes). In this regard, the inauguration of an exchange, the Integrated Nanoscience and Commodity Exchange (INSCX) is a milestone that provides an indispensable framework for enabling effective commercialization, including issues such as standardization and insurance.
The ability to set an appropriate level of insurance premiums presupposes a rational basis for evaluating the risk associated with the insured activity. The medical sciences have long been aware that fine particles and fibres pose health risks - diseases such as asbestosis and silicosis. Other risks are related to the impacts of release into the environment. The post-Gulf of Mexico oil disaster world is sensitized to the huge potential costs of certain environmental disasters.
The risk from simple nanomaterials can already be assessed using well known bio-physico-chemical principles and the appropriate calculations can be made on the basis of data obtained from consulting lookup tables. But as a very rapidly developing field, nanotechnology is constantly creating new and ever more sophisticated materials, whose behaviour in the human organism or in natural ecosystems cannot be reliably estimated by extrapolating from the properties of known systems. This points to the need for further authoritative research. Given the almost infinite number of possible varieties of nano-objects and nanostructured materials, it might never be possible to evaluate the hazard of each individual material, therefore the development of a proper theoretical framework to encompass medical and ecological responses to nanomaterials is an urgent necessity.
This report fulfils a most valuable role in sensitizing the insurance community to some aspects of nanotechnology that have hitherto been largely confined to the realm of the technical expert. If nanotechnology is to be advantageously exploited for the benefit of humanity, a comprehensive approach involving all stakeholders is very necessary, and the first step in developing such an approach is effective dialogue between the different groups involved. This report is an excellent example of how such dialogue can be initiated.
Cranfield, Bedfordshire, United Kingdom, November, 2010
Table of Contents
1. Explanation of Nanoscience & Nanotechnology
2. Application of Nanoscience & Nanotechnology
3. Key issues facing the Insurance Industry
4. Safety of Nanomaterials; extent of risk
5. Nanotechnology and Food
6. Public Engagement
8. INSCX exchange
This document is intended for general information purposes only. Whilst all care has been taken to ensure the accuracy of the information, INSCX exchange does not accept any responsibility for any errors and omissions. Furthermore, INSCX exchange does not accept any responsibility or liability for any loss to any person acting or refraining from action as the result of, but not limited to, any statement, fact, figure, expression of opinion or belief contained in this document.
1. Executive Summary
"Insurance companies have been hesitant to provide coverage to nanomaterial producers for fear of potentially huge liabilities but Lexington Insurance Company is the first to offer nano-specific liability insurance coverage in the United States."
Source: NanoReg, August 2010
This research report compiled by the Integrated Nano-Science & Commodity Exchange (INSCX exchange) at the request of Lloyds of London aims to provide a complimentary follow on to the 2007 Emerging Risk report compiled by Lloyds focusing on nanotechnology.
Advancements in nanotechnology, often described as Nanoscience and Nanotechnology (NN) are making difference already and promise to make major differences in our lives in the not-too-distant future, as the Industrial Revolution did to the agrarian world; to do for the physical world what the computer and Internet have done to the world of information.
It is pointed out that developing a language to talk about Nanotechnology is critical, and not easy since the generic platform is a broad, complex field of scientific and engineering research. Nanotechnology is by definition multi-disciplinary enabling a class of products, applications and devices containing materials built on the atomic scale, radical in nature and not just an enabler of a single product or even group of products.
Over the past decade increased efforts have been made on a global basis to commercialise nanotechnology supported by the creation of substantial state-sponsored innovation and research networks to house the emerging suite of technologies. The increasing commercial application of Nanoscience and Nanotechnology is expected to fashion what some in the industry have referred to as a Paradigm shift, in essence a process of accelerated social and economic change. These generic platforms are expected to impact profoundly in future years on the global economy, creating opportunity for participants who move to restructure capital allocation models supporting existing business, while inhibiting the continuity of economic sectors which fail to adjust. Industry estimates currently place annual trade flows in nanotechnology today in excess of $400 billion, with predictions by 2015 rising to some $2.6 billion.
Nanotechnology has become a topic of widespread discussion amongst researchers, in the media, among the investment community and elsewhere. While there is certainly a degree of hyperbole in some of this enthusiasm, it is no exaggeration to say that nanotechnology is set to disrupt the face of much of industry. Nanotechnology is about new ways of making things. It promises more for less: smaller, cheaper, lighter and faster devices with greater functionality, using less raw material and consuming less energy. Any industry that fails to investigate the potential of nanotechnology, and to put in place its own strategy for dealing with it, is putting its business at risk.
Source: New Dimensions in Manufacturing, A UK strategy for Nanotechnology, Lord Taylor et al, 2002
Ground Floor Opportunity
While the global infrastructure established to "house" and coordinate nanotechnology has acted to shape a significant presence in areas of research, toxicology, materials referencing, testing methodology and innovation support, at the commercial end many nanotechnology businesses have struggled to gain traction. State expenditure thus far has yet to impact positively on Gross Domestic product (GDP). Indeed despite unprecedented levels of state funding, the broad technology has advanced slower than initially anticipated, particularly with regard to sustainable commercial end points. Key deficiencies remain to be addressed relating to issues surrounding safety, education, integration, transparency, compliance and pricing.
A degree of despondency has developed as a consequence of limited progress toward sustained commercialisation as reflected recently by Thomas Kenny, Ph.D., Professor of Mechanical Engineering at Stanford University who in October, 2010 told attendees of the MEMS Technology Summit that nanotechnology promises have gone unfulfilled. "If we define a technology as the ability to make something exactly the way we want it, over and over, we do not have this capability at the nanoscale for many structures."
Nanotechnology is a complex field, and while a future generation of commercial goliaths have yet to emerge from within nanotechnology to dismiss the generic platform as effectively failed would be somewhat a risky assumption to make. The euphoria and fanfare which greeted the emergence of nanotechnology some ten years ago was in large part regarded by informed circles as an inflated hyperbole owing more to an ethos of scientific euphoria an appeal to futurism than assessment of commercial fact. Nanotechnology simply had to go up to come down as it were to experience the reality of the commercial world before it could go anywhere.
When we assess the current state of the industry, it appears nanotechnology is starting to emerge from the research/incubation stage to develop for itself a wider appreciation of commercial realism. A certain momentum is gathering of late, and while initial euphoria has waned somewhat, ample evidence points to nanotechnology commencing then growing up process. Certainly key deficiencies remain to be addressed; regulation, internal commercial organisation and so forth, but there is now a greater willingness to slow down and rationally assess where mistakes have been made.
State sponsored networks are now more extensive than they were five years ago and better geared to provide a hierarchical guidance in critical areas, while capital investors despite the recent turmoil in global markets, are again warming to the ground floor opportunity afforded by nanotechnology. Nanotechnology can start to make significant progressions from here particularly in the event the industry moves decisively to embrace the concept of self-regulation in its commercial end points as a support to official "top-down" regulation. These moves will find a welcome audience on the buy-side and within capital market supports such as the insurance and investment sectors long familiar with the concept of self-regulation.
The technology looks set to develop significant traction from this point of perceived low morale. The industry can extend itself beyond the novel where it has become associated with merely enabling an ever increasing series of nano-enabled consumer deliverables to develop its wider potential. The choice is for nanotechnology itself to take. State networks in nanotechnology stand ready to act in support of a more proactive move to embrace self-regulation and are more capable of providing insight into the safety debate. Added to continuing a process of public engagement to increase familiarity with nanotechnology in general, the future for the industry could prove much more promising and sustainable that appears at first glance.
Of course much more work needs to be done to develop the checks and balances necessary, and to enable traditional business support networks to enter the arena equipped with the depth of knowledge required to engage.
Key doubts remain as to the effectiveness of state-sponsored innovation policies, perhaps even disdain in investment circles at the poor performance of several nanotechnology Initial Public Offerings to date while a clear knowledge gap within traditional economic sectors remains evident despite attempts by some industries playing "catch-up" to promote themselves with a new found expertise. These limitations are among factors pitched against the backdrop of increasing political and social calls for the observance of a wider adherence to safety in nanotechnology.
The absence of clarity on the matter of the regulation of nanoscale technologies remains clearly unhelpful to insurers but progress is being made to provide cohesive answers. Regulation should perhaps be accepted in the first instance as a call pre-empted by the nanotechnology community itself where repeated attempts have been made over many years to engage. Key to understanding regulatory issues surrounding the nano-debate of course requires an appreciation of various legislations and the role of agencies such as the US EPA and EU REACH and the OECD Working party on Manufactured Nanomaterials (WPMN), the latter established in 2006. However, regulation may be better assessed based from a position understanding exactly what nanotechnology is, or more to the point what it is not. The tendency to regard nanotechnology as a junior partner to be included in an existing category of commercial activity can mislead as opposed to inform.
Nanotechnology can be held to be a distinct field of multi-disciplinary activity holding generic application across many existing and new sectors of the global economy. The nanotechnology "community" has developed a highly specialist global infrastructure since 1984 in the UK for example, designed to house and help expand its reach into the commercial world. The past 15 years have witnessed the emergence of significant hierarchical structures in nanotechnology in many countries both developed and less developed.
Traditional commercial infrastructures are not yet fully up to speed with the immediate and radical accelerating nature of nanoscience. In many ways whole sections of society and existing commercial interests have yet to acquire understanding as to the significance of nanotechnology to the existing never mind possible futuristic world. Many established sectors of our economy are only a few years into the game as it were, although some claim for reasons peculiar to themselves a new found expertise. The reality suggests few outside the nanotechnology community proper can appreciate either its substance or conclude the immediate objective as being to engender stabilisation followed by a process of phased integration leading to convergence.
The issue of regulation can be understood more clearly when weighed against these overall objectives. Nanotechnology industry should not be assumed loose-cannon posing a potential myriad of insurmountable obstacles to insurers and other sections of the global socio-economic framework, but in the context of regulation, an industry long calling for effective regulation.
Challenges posed by nanotechnology are complex and potentially far-reaching but by no means beyond the capability of society to manage. What is suggested by this report to insurers is furtherance of a process of collaboration between vital elements of the insurance industry and the nanoscience research and business community as a means to enlist the support of the insurance and capital market industries in particular, enablers which have played a vital, and often stabilising role over the structured progress of innovation over many centuries.
The benefits of nanotechnology can far outweigh risk provided an informed clarity is sought from within the nanotechnology community itself as opposed to elements seeking short-term gain by effectively "jumping on the bandwagon" as it were. However, like any other industry, nanotechnology is afforded a right to campaign for the introduction of practical as opposed to punitive measures to regulate.
"There is so much uncertainty about the questions of safety. We can't tell you how safe or unsafe nanomaterials are. There is just too much that we don't yet know." - Jim Allwood, nanotechnology coordinator EPA (USA), March 2010
The comment cited above provides some justification expressed in nanotechnology circles that official regulators are attempting to regulate an area where knowledge is somewhat limited. While all are in favour of regulation, a key fear expressed of late tends to relate to perceptions a series of gaps in the knowledge base and capability of official regulation agencies, available Round Robin materials referencing methodology and toxicology testing techniques respectively to deal with the complexities of nanoscience and nanotechnology will lead to the introduction of ineffective regulation.
In response to recent June, 2010 EU MEP calls for blanket product labelling of electrical goods containing nanomaterials in their composition, the Nanotechnology Industry Association (NIA) pointed to the proposals being wholly impractical:
"It remains unclear precisely what the MEPs deem to be nanomaterials. If they follow the definition used in the Novel Foods directive, then it would mean any material engineered or manufactured to be of the order of 100nm in at least one dimension. This, however, would lead to every electronic product requiring labelling. 'Every transistor in a computer chip would then include a hazardous substance,' explains Steffi Friedrichs, director general of the international Nanotechnology Industries Association. 'Labeling is an understandable consumer demand, but it needs to be practical, and labeling every computer chip would be nonsensical. The sense behind banning long multiwalled carbon nanotubes is more apparent; for example, there is some evidence that they may behave like asbestos when inhaled. But even then, the nanotubes have to be free for inhalation, which would not be the case if they were bound up in an electrical product. 'The properties of each material must be evaluated according to application, and on a case-by-case basis,' says Friedrichs. 'In final products, the potential exposure to carbon nanotubes is negligible, and during the manufacture and formulation process adherence to safety standards is essential.'"
Following Commercial Logic
Clearly there are very real concerns and safeguards must be enacted as the case would be with any material suspected or proven to pose a hazard. However, calls to ban nanomaterials would create a legal precedent to ban at a whim almost any material. An analogy cited by Tim Harper, CEO of the technology think-tank, Cientificia and author of a series of reports on nanotechnology regarded by NASA as being among the most defining to date, cited the example of placing sulphuric acid in a tea-pot.
"We all know it would be a silly and impractical thing to do as the substance is clearly harmful. However, we still use the acid, but in a manner where we can control risk of exposure through implementing logical storage, handling and end user competences."
The analogy of working with "dangerous" substances was reiterated by Christopher Dale, an executive at BASF, the German conglomerate active in nanotechnology, in an address to the Lighthill Risk Network earlier in October where reference was drawn to the very strict internal procedures BASF have for dealing with hazardous substances.
Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development and Consumer Protection in July, 2010 has put forward five proposals worked out by the Belgian Presidency to respond to consumer needs whilst ensuring their safety. The proposals for a basis to progress matters forward. I some but not all respects nanobusiness can incorporate in a manner complimentary to business with the efforts of INSCX exchange to implement an effective self-regulatory global traceability referencing to source. This system outlined subsequent is further supported by Contingency Shut-Down measures involving the levy of a premium on all exchange transactions as a buffer to compensate for any suspension of trade in a listed material in the event a societal risk is proven to emerge.
a) Define the obligation to inform the consumer of the presence of nanomaterials in consumer products.
b) Ensure the traceability of the chain so as to be able to return to source, if necessary. Regarding this aspect, it would be obligatory to maintain a register of nanomaterials.
c) Identify the most appropriate regulatory path at the EU level for risk evaluation and management.
d) Encourage member States, during this transitionary period, to take up the responsibility and draw up integrated national stragegies and concrete measures in favour of risk management, information and monitoring.
e) Regulate the claims made on labels of products containing nanomaterials.
Regulation agencies are encouraged to adopt a similar rational approach to the issue of nanomaterials and to use available tools in society to help support a compliant observance of standards in regulation. It must be remembered that the world of business has long regarded a societal concern as equating to a risk or in effect a commercial concern given the very real possibility any proven negligence will lead to incidence of cost through risk of litigation.
The nanotechnology business community fully appreciates this linkage between societal responsibility and corporate reality. The community has gone further than most to devote immense effort to continued research and study to devise good practice, and more importantly feels it can with a degree of justification call for an end to the practice of promoting an adverse nano-mania based on perceptions of "nanobots" or "Grey Goo" running wild to the detriment of society.
Nanotechnology is a real industry with potential that takes its responsibilities in terms of society with the utmost sincerity and stands willing to extend a collaborative invitation regulators and the insurance industry to decide how best to progress toward a situation where society can reap the benefit on nanotechnology, while supporting effort to mitigating risk associated with furthering commercialisation going forward.
It is suggested the insurance industry search beyond the optics of the recent spurt of regulatory furore and commentary. Perhaps the best policy stance to adopt would be one retaining a watching eye on the inevitable two-and-fro of the regulatory debate as it invariably continues, while not losing sight of its (the insurance industry) own requirements for clarification on key issues to enable an impartial, objective assessment of current and future opportunities.
Access to key resource networks on a global basis capable of delivering clarity in nanoscience is already available to the wider business community. Within the UK alone a series of Nanoscale Open Access Centres proved the somewhat watered down outcome of debate following the publication in 2002 of the defining strategy report; "New Dimensions in Manufacturing". These centres were designed to enable existing business to get involved, although limited knowledge filtered down through the local development agency networks.
While translating hierarchical initiatives in nanotechnology down to impact at grassroots level continues to be a perennial problem, the challenge is being met worldwide in gradual, incremental stages in tune with the overall strategy of integration. The entire rationale of global state-sponsored efforts over the past two decades to build an infrastructure to house and guide inputs into natotechnology has been based on providing information and research support to enable indemnification as a key driver toward sustaining commercialisation.
What has muddied the waters somewhat has been the painful and costly proving of structural weakness in the commercial interface of nanotechnology since 2002 compounded by an accepted regulatory limitation intertwined with the scramble by many commercial elements, existing and new to play "catch-up" and the emergence of nano-enabled consumer products in some abundance without appropriate adherence of consumer rights.
Reference is drawn at various stages throughout this report to a number of useful and very often freely available support networks and studies in key areas relevant to issues facing insurers as they move to accommodate and structure their business to integrate further with the emergence of the generic platform.
While nanotechnology continues to grind forward, gaining further momentum in its own right granted, it equally desires to integrate as a compliment as opposed to a disruption. NANOFutures, a EU sponsored technology coordinating platform, a platform recommended by the authors of this report as key resource point contact for global insurers, underlines the integrative approach and the significance to attach to the emerging field is outlined as follows:
"Nanotechnology will help Europe to address global challenges such as climate change, constraints in energy production and shortage of resources, insufficient access to clean water and food safety, as well as widespread diseases and affordable health care worldwide. However, the true potential of nanotechnology is not yet exploited exhaustively. To overcome this and ensure that Europe will not stay behind in the global competition, NANOfutures will bring together industry, research, networks NGO's at all levels for a joint movement towards a new industry."
While there are several obstacles yet to overcome, there are undoubted promising developments such as the impending launch of a dedicated commodity exchange process to structure trade in the raw materials base of nanoscience and nanotechnology later 2010. This project represents a significant private commercial development for the nanotechnology "community" for the opening of INSCX means that for the first time nanomaterials may be traded in the same way as the basic commodities that have for many years been the foundation of industry and food production.
The historic trade in commodities allowed purchasers across the world to buy goods sight unseen, knowing that since they were commodities the goods they were buying had to have met minimum standards of quality. This greatly facilitated the trade in these raw materials, and ceteris paribus had a downward effect on price. Larger quantities were available for lower prices, allowing the cheaper production of finished goods and foodstuffs. The opening of INSCX exchange means the same benefits will now pass to nanomaterials where the process will develop supply capacity to provide larger volumes to producers, where the nanomaterials purchased will be of assured quality and will be more competitively priced.
This step is essential if the manifold benefits promised by nanotechnology are to be realized. The producers of the first generation of nanotechnology based products that are widely available to consumers and industrial clients will have to have access to large amounts of inexpensive raw materials to facilitate research, development and mass production.
The opening of the INSCX exchange means the age of cheap, ubiquitous nanotechnology is now at hand.
While small in comparison to combined trade based on the use of existing materials, trade in nanomaterials must be viewed as being generated with limited private capital support to date. The effort at commercialisation despite its limitations can only be regarded as impressive for any emerging industry. The deliverance of standards in trade and material quality based on a "true and fair" price discovery through the "hub" of a commodity exchange process will act as an objective catalyst to bolster ongoing efforts to increase industry awareness enabling a greater commercial uptake and capital support to flow toward nanotechnology.
As traction develops nanotechnology itself will move from a structured process of integration to convergence, enabling a Paradigm affecting whole sectors of the global socio-economic structure. Applications are gaining increased commercial momentum in the following sectors; Aeronautics, Construction, Energy, Consumer Electronics, Engineering, Mining, Metals, Medicine, Polymers and IT are among sectors where an increasing use of nanomaterials will create a series of opportunity and risk. Risk going forward we suggest as needing to be regarded extending beyond societal concern to include commercial and economic aspects.
While ample research content is available to assist insurers become more familiar, we reiterate the purpose of this report is to present an informed snapshot as opposed to a comprehensive study.
INSCX exchange would like to thank many who have contributed thought and insight into this summary report and in particular Lloyds of London for commissioning the exchange research department to present its views for consideration.
Of notable mention as contributors are the persons associated with the following resource networks across nanoscience; Minam, NanoFutures, Cranfield University, NanoReg, SAFENANO/AssuredNano, UNCTAD, University of Western Australia, Keele University, Brunel University, Institute of Nanotechnology, Cambridge Nanomaterials Limited who acted to encourage this report. We are grateful to the many contributions from within nanotechnology and from participants engaged in the global securities and commodity industry, who provided resource access and time in many cases to make constructive observations.
The suggestions put forward in this report are not intended to represent views held by Lloyds of London, its affiliates or membership, but rather observations and conclusions put forward for consideration with the approval of INSCX exchange.
Report compiled by: Economic Research Unit, INSCX exchange, United Kingdom November2010
2. Explanation of Nanoscience & Nanotechnology (N&N)
Nanotechnology is no longer simply a science of the future, but it is a way of producing and using materials at a tiny scale that is rapidly entering our everyday lives in cosmetics, medicine, food, sports equipment, computers, automobiles, and many other consumer products.
Source: Consumers Talk Nano Dialogue, October, 2007
Nanoscience is the study of phenomena and manipulation of materials at atomic, molecular and macromolecular scales where material properties differ from those at a larger scale. Nanotechnology is the design, characterisation production and application of structures, devices and systems by controlling their shape and size at the nanometer scale. Nanomaterials cross the boundary between nanoscience and nanotechnology linking the two areas together creating a basis to engineer a broad, generic suite of alternative raw materials holding multi-sector industrial and commercial potential.
The word "nano" itself refers to the length scale (one nanometre is one billionth of a metre) that is one thousand times smaller than the micro scale, the scale that was traditionally associated with the electronics industry. Viruses and DNA are examples of natural objects on the nano scale, in contrast a human cell can appear enormous. The term nanotechnology refers to the engineering, measurement and understanding of nano-scaled materials and devices. Manipulating matter atom by atom and creating features on the atomic or "nano" scale is now a proven technology and there is an ever growing catalogue of commercial interest that utilizes the field. The National Nanotechnology Initiative which coordinates the nano-scale science of 26 federal US agencies, defines nanotechnology:
"The understanding and control of matter at dimensions of roughly 1 to 100 nanometres, where unique phenomena enable novel applications"
The use of nanomaterials delivers an ability to fashion advanced materials across a broad spectrum from polymers, metals, coatings, inks to catalysts, electronics and other deliverables using defined production and characterization techniques. The paradigm aspect inherent in nanomaterials relate to potential in the fields of guided and molecular self-assembly. Nanomaterials which are "engineered" or man-made in themselves can be regarded as an alternative, more functional or user-friendly offering of raw materials capable of being used to deliver products, devices and applications in sectors as varied as energy, electronics, defence, medicine, transport, communications, information technology and biosciences.
Together N&N equates to a radically enabling Technology Platform holding potential to engender an economic and social paradigm shift on a revolutionary scale as use moves from integration with existing economic and social structures towards wider convergence. N&N should be regarded as representing distinct scientific and engineering fields as opposed to being assumed a part of any existing industrial sector. Indeed there is ample evidence to suggest traditional sectors of the global economy are as yet largely unfamiliar, or in certain cases only finding their way in the generic fields. N&N is multi-disciplinary in character, in effect moving between the world of physics, chemistry, biology and metrology. Nanomaterials are used to produce not just a single product or even group of products. Rather use for nanomaterials extends to include a multitude of products applications, devices and objects. As a consequence there are several different types of nanotechnology, and many applications associated with each type. There are also several other types of nano-sized objects which exist in our environment, both natural and unnatural. The table below summarises the main types of nanotechnologies and nano-objects providing examples of current or future application.
Electronics, optoelectronics, building materials, sports equipment.
Films and coatings
Self-cleaning coatings, waterproofing, antimicrobial coatings e.g. medical equipment, food containers and appliances.
Unintentionally created particles
Metal smelting, burning fossil fuels including petrol and diesel.
Nano-sized motors, medical diagnostics
Particles emitted from volcanic eruptions and forest fires.
Food and cosmetic additives including sun screens, anti-microbial uses, pollution clean-up
Nano-electrical mechanical systems (NEMS)
Drug delivery and diagnostics, smart sensors
Classification of Nanotechnology (NanoStages)
What is important to understand is how nanotechnology classifies itself into a series of stages or generations; passive, active and hybrid. Another view runs to include four stages or generations. This latter classification is presented by M.C Roco, one of the driving forces behind the US National Nanotechnology Initiative (NNI). We list the generations below cited in abstract from the 2009 Oversight of Next-Generation Nanotechnology report complied by the US based Project on Emerging Nanotechnologies (PEN). The full report can be accessed at:
A category combining a nanomaterial with some other material to add functionality or value, where the behavior of the nanomaterial does not change appreciably over time.
Involves nanoscale structures that alter in response to changes in their environment. Alteration might result from mechanical force, a magnetic field, exposure to light or the presence of certain biological molecules or a host of other factors. Active nanostructures are envisaged as being integrated into larger devices or systems. Examples could include new transistors and other electronic components, targeted drugs and chemicals designed for particular functions.
Systems of Nanosystems
The following quote is attributed to MC Roco describing "third generation" nanotechnologies as being:
"Systems of nanosystems with three-dimensional nanosystems using various syntheses and assembling techniques such as bioassembling; robotics with emerging behavior, and evolving approaches." It includes "directed multiscale self assembling … artificial tissues … and processing of information using photons."
The fourth generation "will bring heterogeneous molecular nanosystems where each molecule in the nanosystem has a specific structure and plays a different role."
Source: MC Roco
While many observers have difficulty understanding the difference between the "third and fourth generation" as identified by MC Roco, most share the view that an important aspect of nanotechnology will be its integrating with other technologies to create complex and innovative hybrid technologies.
When we hear commentators refer to the "Paradigm Shift" they are referring to the social, environmental and economic impact likely to be brought into being through advances in the third and fourth generations of nanoscience witnessing the very real prospect of widespread use of automated or guided self-assembly and molecular self-assembly techniques.
According to the 2009 Oversight of Next-Generation Nanotechnology report, "The ability of nanotechnology to engineer matter at the smallest scale is already opening up new advances in biotechnology, information technology and cognitive science."
Where we are now?
We are currently witnessing the integration of passive or first generation nanotechnology; where the broad suite of technologies are being used to create more functional materials as compliments and eventual rivals to existing materials, to the emergence of Smart Drugs (Advanced Cancer Treatments), Military Applications (Battle Suits), Next-generation Computer Processing (where IBM has since 2007 used air-gap self-assembling nanotechnology to increase flow in chips), Programmed Biology, Complex Materials, Metamaterals, Photonics, Energy generation and use.
Progress to date in a commercial context has been gradual as opposed to spectacular. Many issues remain to be addressed, not least how nanotechnology develops for itself consensus on standards in Health and Safety and an effective commercial model. In order to appreciate where nanotechnology has arrived in a commercial context, and areas where further commercialisation may occur, the next section of this report provides a summary insight.
3. Application of Nanoscience and Nanotechnology
"Nanotechnology, if even partially realized, over the next few decades has the potential to realign society, business and economics at the structural level. Nanotechnology will touch all aspects of economics: wages, employment, purchasing, pricing, capital, exchange rates, currencies, markets, supply and demand. Nanotechnology may well drive economic prosperity or at least be an enabling factor in shaping productivity and global competitiveness."
To prove the potential benefits inherent in the application of nanoscale technologies, we avoid the customary reference to cosmetics, sports equipments and the multitude of other novel but nonetheless useful consumer products and applications to focus on applications and areas where nanotechnology is currently being used to deliver end products to safely tackle very real, socio-economic issues. We focus on the cases of fuel consumption/harmful emissions, water filtration, electronics, medicine, metals and the use of silicia based Aerogel or Nanogel to create unique lightweight insulation solutions and use in spill management and remediation.
Manufactured by Cerion Energy in Rochester, NY, Go2/SynthetiCat is a 3rd generation Cerium Oxide diesel fuel borne catalyst which when added to fuel without need for vehicle modification has been proven to reduce fuel consumption by 10% and harmful emissions by as much as 30% while use in Bio-blends of diesel have shown impressive cleaning qualities. The first generation of this technology is already used widely and endorsed by a leading UK public bus fleet.
Cerium oxide is used as a polishing agent for glass mirrors, plate glass, television tubes, ophthalmic lenses, and precision optics. Cerium oxide is also used as a glass constituent to prevent solarization and discoloration. Cerium oxide is also used in emission control systems in automobile engines as a diesel fuel-borne catalyst to reduce particulate matter emissions.
Use of Cerium oxide formed the subject of an extensive study cited in abstract below:
PROSPECT: Ecotoxicology Test Protocols for Representative Nanomaterials in Support of the OECD Sponsorship Programme, July, 2010
There is some evidence that Soot is the second most effective atmospheric global warming pollutant and that a reduction in soot emissions might be a relatively easy ‘win' in the battle against global warming. Products that reduce the formation of CO2 and soot while reducing the fossil fuel consumption, potentially provide huge benefit to the consumer, in reduced fuel bills, and the environment, in the reduction in greenhouse gas formation.
"Modelling studies based on use of cerium oxide based fuel additive across Europe indicate that the application of exhaust filters in conjunction with cerium added diesel will have a significant effect on the unit emissions of diesel vehicles. It was estimated that the reduction in emissions would vary from 70% to 90%...results indicate that no major contamination of the soil would be expected and indeed that levels of cerium oxide in soil would be of the same order of magnitude as those found naturally in cities across the world today."
Seldon Technologies manufacturer of a series of nano-enabled portable domestic and industrial scale water housing systems proven to eliminate toxins. According to the company website, Seldon is "expanding the boundaries of science, creating new filtration materials for the betterment of the world's population. Seldon has created novel nanotechnology filtration products which will save lives, clean the environment and help restore the balance between humans and the Earth's resources.
"Seldon's proven and tested products quickly clean water, air and fuel without the use of heat, chemicals, power, ultraviolet light or contact time. Seldon's water products function at a high flow rate to EPA drinking water standards."
The European Technology Platform for Nanoelectronics is a key nanotechnology platform initiative developed through ENIAC (European Nanoelectronics Initiative Advisory Council). Operating as public-private partnership, bringing together the European Commission and European Member and Associated States with AENEAS, the association represents the main Research and Development actors in Nanoelectronics (companies, research centres and universities) in Europe.
Microelectronics has changed our world drastically: computers, mobile phones, digital television, DVD players, car navigation and security features, medical screening and health care equipment have all become essential parts of our everyday lives. Nanoelectronics is just the next evolutionary step, as the number of transistors that can be integrated on a single chip reaches one billion, nano-electronics represents a revolution marking a dramatic step forward.
Further details can be accessed using the website link:
The EU NANOMEDICINE platform initiative is another key area and is an initiative led by industry and set up together with the European Commission, aims at strengthening Europe's capacity to organise and to deliver innovation in the area of nanomedicine. The ETP Nanomedicine aims at bridging the gap between research and product development, promoting the industrialisation of nanomedicines to bring real benefit to patients in the shortest possible time. An extract from the cited mission statement reads:
"Nanomedicine, the application of nanotechnology to health, raises high expectations for millions of patients for better, more efficient and affordable healthcare and has the potential of delivering promising solutions to many illnesses. Research in nanomedicine will allow for a better understanding of the functioning of the human body at molecular and nanometric level and it will thus give us the possibility to intervene better at pre-symptomatic, acute or chronic stage of illnesses.
"Several areas of medical care are already benefiting from the advantages that nanotechnology can offer. The first nanotechnology-based targeted drug delivery systems are already on the market, others are in clinical trials or, by far the largest part, are under development. Another highly attractive area of nanomedicine is diagnostics at nanoscale. The aim is to identify a disease at the earliest possible stage. Ideally already a single cell with ill behaviour would be detected and cured or eliminated. New concepts for regenerative medicine give hope to many patients with organ failure or severe injuries. Already today artificial skin, bone and cartilage are in an advanced stage of development and partly already on the market."
Further details can be accessed using the website link:
Snapshot; Medical Potentials
One area where nanotechnology continues its focus is in the area of medical research. For example, the US National Cancer Institute (NCI) (nano.cancer.gov) launched a cancer nanotechnology plan (CNPlan) in 2004 addressing the need for nanotechnology in the diagnosis, treatment and prevention of cancer. Specific goals of the CNPlan included the development of five Centers of Cancer Nanotechnology Excellence, with integrated, milestone driven and product oriented projects. The ultimate goal remains to "eliminate suffering and death from cancer by 2015". While this may appear an ambitious statement, it warrants a seriousness given its origins. We must also consider not only the benefit of any measure to help society overcome cancer, but also the displacement impact such a development would hold for existing participants in the race to find cures for major diseases.
Manufactured by Cabot Corp, Boston, one of the world leading suppliers of Carbon Black, a nanomaterial used extensively in tires and inks, Nanogel® is Cabot's brand aerogel. Aerogel was first invented over 75 years ago and is pure aerogel in granular form, which can be used on its own or in conjunction with other materials to suit the specific needs of a wide range of systems.
Each granule consists largely of air (>90%) contained in a nanostructure with pore sizes less than the mean free path of air molecules, which severely inhibits heat transfer through the material. Cabot produces Nanogel aerogel at its state-of-the art manufacturing facility located near Frankfurt, Germany, where it began commercial production in 2003. Nanogel aerogel is recyclable, reusable, safe for human and ecological systems, and is created through a closed loop process with little to no impact on the environment. It is currently being used extensively in high value, demanding applications in daylighting and oil & gas insulation around the world.
Source: Cabot Corp
The relevance of nanoscience and nanotechnology is attracting the attention of several key players within the global steel industry. Currently, there is a growing awareness about the potential benefits of nanotechnology in the modern engineering industry, and a number of leading research and development institutes and companies are pursuing research particularly in the area of nanostructured steels. The focus of the ongoing efforts has been largely manipulation of microstructures at the nano‐scale through innovative processing techniques and adoption of novel alloying strategies. This is being aided by employing advanced characterisation methods like high resolution transmission electron microscopy (HRTEM), atom probe tomography (APT) etc. and computational design of materials.
Applications of nanostructured Steels
The following applications using nanostructured steel have emerged or are in advance state of development are; Defence (Ballistic armour), Aerospace (Aircraft landing gears), Medical (Surgical needles and clips), Sports (Mountain bike frames), Consumer (Shaving razors), Oil and Gas (Pipeline Steel), Infrastructure (Concrete reinforcing bars), Nuclear (Fuel cladding for nuclear reactors), Power (Advanced exhaust components for heavy duty diesel engines), Automotive (Automobile body-structural, chassis and suspension parts) and Industrial (Cutting tools and bearings).
Summary of Use and Potential
Almost every area of human activity will be affected by nanotechnologies. As has been demonstrated, many applications are benign involving use of nanomaterials long a feature of our world. Medicine, food, clothing, defense, national security, environmental clean-up, energy generation, electronics, computing and construction are among the leading sectors that will be changed by nanotechnology innovations.
While the prime focus has been on assessing potential societal risks posed through increased use of nanoscale technologies at the current Passive nanoscale or first generation integration stage, risk by definition can also be assumed to take on a socio-economic flavour. How will the emergence of rival materials and new manufacturing processes affect the world of capital, employment, GDP, or impact developing nations heavily reliant on more traditional commodity exports? How will our world react when the semiconductor roadmap "runs out" by 2015 as existing technological capability cannot keep pace with demand for computer processing capability? These are among questions posing themselves to national governments, society, business and commercial supports alike and underline the complexity to associate with the potential for rapid acceleration to associate with nanotechnology.
Consideration of these features in addition to consideration of the ongoing Health & Safety debate underline the conclusion held by the nanotechnology community that clearly defined structures and systems must be enacted to dovetail a wider adherence to commercial and ethical Health & Safety standards not only to progress the commercialisation of nanoscience or safeguard society from potential EHS risks, but wholly critical to engender a smooth transition of capital from its commitment to existing to new technologies in the interests of ensuring global socio-economic stability.
Assuming risk in the context of nanotechnology relates solely to a series of consumer products nano-enabled to some degree or other, while certainly necessary to devise safe frameworks, will not be enough to deliver what is required.
INSCX exchange Snapshots: www.inscx.com/Page24.html
4. Key issues facing the Insurance industry
"Nobody in the nano industry benefits from companies making hyped-up and unsubstantiated claims about nanotechnology's benefits and in the absence of more formal government regulation, self-regulation by industry could be a step in the right direction."
Source: David Rekeski, Director Project on Emerging Nanotechnologies, March, 2008
While many aspects of study to date have pointed to the potential benefits of nanotechnology and nanomaterials to commerce and society in general, the purpose of this report is to remain firmly focused on assessing possible solutions to address key risk-mitigation issues facing the insurance industry in relation to nanotechnology. We provide insight into possible risk, both immediate and "long-tail" and how limitations in the commercial infrastructure of nanotechnology act to compound difficulties faced by insurers seeking to consider indemnifications of the sector. We also touch on risk posed as a consequence of wider socio-economic implications should nanotechnology develop its current "first" generation stage and assess risk likely to surface as nanotechnology progresses in the future.
Nanotechnology draws our attention to a series of challenges; social, political and economic in character posing equal difficulty in addition to opportunity. There does exist a tendency even within the nanotechnology community to attempt to approach matters in a collective, all-embracing manner seeking to address each of the various issues all at once; Regulation, Standards, Visibility, Traceability, Global nature, socio-economic consequence, commercialisation and so forth.
This approach can serve to overwhelm as oppose to inform. It is suggested the insurance industry resist a similar tendency opting instead to approach the subject of nanotechnology from source in a systematic manner working from this source point of departure to state clearly what it (the insurance industry) feels it requires as basic absolutes to be put in place by the nanotechnology community itself as a prelude to further interaction. We move first to suggest some of the issues facing insurers as they approach the sector.
Risks to Insurers
As we progress a real-world scenario from where nanomaterials are today finding use to deliver more functional materials as a base to manufacture products, applications and devices, to consider possible future scenarios involving higher applications in nanoscience, what can we regard currently as the key issues facing the insurance industry in the context of its approach to nanotechnology?
In dealing with the issue of risk, we define risk in the context of nanotechnology as societal, environmental, commercial and economic.
Our preliminary analysis focuses on current limitations inherent in the nanotechnology infrastructure evident at commercial end-points and the issue of risk to consumers, factors which can weigh heavily to influence insurers to engage any sector.
Fog of Confusion
Nanotechnology owing to its myriad of complexities has created for itself in essence a fog of confusion through an effective information overload and a "rush to market" in a manner which leaves the industry open to criticism, particularly in the case of nano-enabled consumer products. While perhaps the significance to attach to nanotechnology appears logical to those involved with the field, to the average observer and commercial world in general, the abundance of information, discussion and the headlong rush to bring nano-enabled products onto the market can be confusing.
Product marketing at consumer level opens up a situation even in the case of "normal" products where the slogan effectively sells and product suppliers are confronted with having to meet consumer rights and other commercial conventions.
Nanotechnology finds itself called to face a series of challenges:
1. To explain itself in a language those less familiar can understand
2. Compelled to act given the socio-economic ramifications of any nation falling behind in the nano race
3. Disparities between developed and emerging markets
4. To address a situation where regulatory response does not appear consistent or underpinned by an accurate definition of the science
5. Difficulties compounded when we consider nano-enabled products are being brought onto the market with limited adherence to fairly standard commercial conventions
6. Slogan marketing of consumer products undermining or cheapening the worth of nanotechnology as a multi-disciplinary platform
7. Limitations inherent in existing toxicology and Round Robin methodology particularly in the evaluation of "long-tail" risk possibilities
8. Facing a position where it appears to be commercialising something it admits it does not fully understand, more reflective of focus on third generation as opposed to first generation nanoscience, all contributing to consumer fears of "nanobots"
9. Having developed no-effective self-regulatory means to allocate or grow supply capacity enabling market checks and balances to be introduced at the source nanomaterial stage proving valuation or adherence to base commercial standards
10. Lack of market discipline limiting an ability for capital to reallocate to integrate nanomaterials, a factor inhibiting insurance underwriting teams to value risk versus reward
11. Failure to appreciate the ability of natural market process by way of structured exchange as capable of engendering a practical global mechanism to support official regulatory measures including calls for traceability in the allocation of nanomaterials from source to end-product
12. Access to limited capital resource at SME level to upscale adherence to benchmark EHS standards where capital limitations are forcing companies to sell to survive
13. Continuance of hyperbole tendencies undermining the depth of work completed to create a supporting infrastructure
14. Facing a threat of dominance where existing sectors seek to claim ownership of nanotechnology
Avoiding the Blame Game
The situation equates to one where all aspects of the "commercial" arrangement (Manufacturers, Regulators, Industry Associations, Downstream users, insurers, professional supports etc) are perceived at fault in some way or other. There is clearly a problem which must be addressed in a rational, systematic manner. Using nanotechnology, or any means of manufacture for that matter, to bring end consumer products onto the market where there is doubt as to safety is easily perceived as irresponsible. What matters is where responsibility rests and ends and nanotechnology must resist a temptation to permit frustration to act as a guiding theme in its response to regulators who are compelled to discharge their societal duty.
The blame game scenario will not work, no more than presenting nanotechnology in a manner which fails to on occasion to promote an understanding of society and economics that goes beyond a common appeal to futurism works to promote nanotechnology as a responsible field of human endeavor where society has not been groomed or educated to understand the benefits. Nanotechnology needs to move forward in stages. First generation nanotechnology, by this we refer to the use of nanotechnology to create better materials as compliments or indeed replacements for existing materials has several options open to it.
1. Interest in nanomaterials has for example an option to adopt methodologies long used to unite competing interest concerned with the efficient and compliant allocation of materials or resources from source to end product.
2. On the other hand nanotechnology can retain the notion that somehow the unique features of nanomaterials means they are above being regarded as raw materials in a commercial usefulness context.
As materials such as steel, bulk polymers, rubber, wool and so forth are areas where nanomaterials are hoping to compliment, surely logic would lend favour toward option 1 above? Commercial and societal responsibility commences at source in the supply-chain sequence, where both trade supplier and buyer of raw materials used to further a process of manufacture toward end product each hold certain degrees of responsibility.
The supplier is called to supply something which is useful and safe, while the buyer is called to use the supply in a manner capable of producing an end product both useful and safe to the end buyer where both are called to observe consumer rights and basic commercial conventions of accountability.
The insurance industry relies in many cases on the proven assurance these responsibilities are being discharged as a basis upon which to calculate risk versus reward in the context of any material. The failing in nanotechnology can be suggested as residing in many respects at the commercial as opposed to scientific, government or academic end. The function of science remains to invent, academia to research and government to encourage. Much of the work to arrest the commercial deficiency has been completed and form part of the rationale for creating the nanotechnology infrastructure in the first place.
The baton passes to those supplying and using nanomaterials to use the offering of science, academia and government to continue toward sustained commercial exploitation. However, any assessment of the impact of ongoing and necessary debate underlines clear failings at commercial end points as contributing to a situation where the established infrastructure appears to come somewhat unstuck.
Society and the commercial world proper are assumed in a position to decide in favour or against something often described as belonging to the world of chemistry, engineering, life-sciences to computing where the enabling raw materials (the something) are being used to place products on the market for sale to industrial and consumer clients bereft of observance of clear safety and trade standards enabling a safeguarding of consumer rights or use of materials to be priced in along the supply-chain to end product. This position is not sustainable from either a commercial or societal interest perspective. Politicians and other interest groups now feel compelled to act and are likely to introduce ineffective regulation as many observations tend to reflect fear as opposed to fact.
The suggestion is for nanotechnology to focus on the experience of past innovations which successfully crossed the boundary from cottage stage to industrial scale organisation in a commercial context. Nanotechnology is of course complex, radical and must keep an eye on its futuristic implications. The latter aspects of the technology represent in effect a hierarchical undertaking whereas commercial interests at the first generation stage are encouraged to address the "nuts and bolts" of current commercial convention.
What do Buyers want? How do nanomaterials finance supply capacity while furnishing proof to meet buy-side requirement? What obligations should regulators impose on nanomaterials suppliers and in turn impose on secondary or downstream users of nanomaterials? Should regulation involve what appears of late to represent haste to judgement in response to the increasing availability of nano-enabled products in the marketplace? How can what is supplied be insured to meet commercial and societal requirements? What disclosures are needed by regulators? What mechanisms do existing materials sectors use to meet these requirements and can they be dovetailed to suit the peculiar nature of engineered nanomaterials? These are among the questions which rest at the heart of determining any process toward sustainable commercialisation.
While there are no simple answers, there are some measures which the nanotechnology community acting on its own accord could introduce to make the whole issue of safety and sustainable commercialisation easier to progress. What remains equally clear however, is a view suggesting no vested interest, neither commercial nor societal, is best served continuing the path thus far taken to achieve the aim of compliant commercialisation. Nanotechnology is not in many respects organised effectively on a commercial footing and remains largely fragmented with certain aspects of its potential gaining a front-end consumer good traction. The existence of fragmentation is not to be assumed a fault or a mistake peculiar only to nanotechnology, but rather a continuance of experience on the part of any new technology throughout economic history. The world of commerce we know today did not become manifest in an instant or over a single decade. Rather the enactment of systems of exchange, insurance, regulation for example took time, often a long time to get right. Nanotechnology faces one clear advantage insofar as the experience of others provides a template and when we consider the commercial frameworks that house commerce today stem from the period of the Industrial Revolution, nanotechnology holds the benefit of an access to instant as opposed to protracted communication mediums. These advantages we should use to eliminate fragmentation.
Fragmentation in itself given the risks presented, real or imagined, points to increasing potential sources of risk to global insurers, and by definition forcing official regulators to enact an all embracing or blanket response to the matter of regulation. While this report shares concerns that regulation agencies need to learn more at an operational level the definition, scope and specific opportunity for application in nanotechnology, we suggest equally that nanotechnology participants must work to do some of the "heavy-lifting" as it were.
A Shared Responsibility
To date, almost the entire burden to regulate nanotechnology in societal interest has been burdened on the shoulders of an already over-stretched and under resourced official regulatory system. That is not to suggest official regulation agencies "cannot do the job" but suggest that the nanotechnology industry must emerge from its proverbial cocoon to recognise its clear obligations to not only the pursuit of commercial opportunity, but its responsibilities to society in general. The industry can say it is prepared to collaborate, indeed position itself to respond openly to queries raised by official regulators. That in itself is not enough and should not form the extent of commercial proponents of nanotechnology's interaction with official regulation agencies as they strive to enact a structure.
Rather we suggest nanotechnology itself needs to "put its own house in order" and move with a pace to enact a self-regulatory structure somewhat quicker than evident to date. We regard the wait and see approach as a key risk going forward, and one which stands not only at odds with enabling better regulation in societal, but equally commercial interests.
Continuing the current approach where comercialisation continues unabated in the absence of workable regulations, against the backdrop or threat of all-embracing regulatory response, serves no-ones interest. Nanotechnology itself stands indicted, if not undermined by its position adopting in essence that of the permanent opposition in a parliament; Very active and good at dismissing the party in power, but short on offering an alternative. Feigning alarm at every measure enacted by regulators, or wondering why insurance companies and capital investors are not rushing to deliver a support betrays us all in nanotechnology as commercial infants.
Regulation is clearly a requirement, but more to the point we as an industry surely need to help shape its remit. In simple terms, if we move to accept that official regulation agencies do not know everything, and for a moment place ourselves as an industry in their shoes, where non-accredited consumer products are awash on the market, this situation points up our duty to guide and inform, if not to present regulators with a working template. Nanotechnology is advised to slow down and get the basics right, to adopt a position of engagement with global regulators, insurers and capital investors providing clarity based on fact as opposed to futurism and the continuance of a corporate irresponsibility bordering on a mania.
Apart from the fact a taking stock at this stage would appear to serve the commercial interests of nanotechnology in ensuring commercialisation did not by design pose a threat to societal safety, or the potential threat was controlled by way of contingency as best as feasibly proved possible, it is nanotechnology that stands in the shoes of the salesperson, not national governments, consumers, insurers, investors or official regulators. The target market for nanotechnology remains very much the same as proves the case with any commercial activity; the potential end-buyers and enablers.
By target market, we refer to existing commercial participants, consumers, the pivotal supports of finance, investment and insurance along with national governments and official regulators. We suggest the nanotechnology community engaged in commercial exploitation should consider taking stock to assess impartially what each element of the target market may require to meet not only the interests of nanotechnology itself, but individual interests. This development would enable nanotechnology to take measures now to devise working alternatives in structure to satisfy the various requirements, and by so doing help shape and strengthen the wider regulatory framework. The enactment of commercial strategy going forward based on meeting these requirements opens the path to sustained and compliant commercialisation to the benefit of all participants not to mention acting to go some way toward lifting the "fog of confusion" that has stymied progress toward that end thus far.
5. Safety of Nanomaterials; extent of risks
On June 8, 2010, the Organiaation for Economic Cooperation and Development (OECD) announced the publication of two materials for use in the OECD Sponsorship Programme in relation to manufactured, or what is commonly referred to in the industry, as "engineered" nanomaterials. The first is a revision of the Guidance Manual for the Testing of Manufactured Nanomaterials. According to OECD, the revised Guidance "is intended to support the testing undertaken in the context of OECD'S Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate, and consistent." OECD states that the second document, entitled Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, was published to assist the sponsors of the OECD Sponsorship Program, as well as to help others involved in the safety testing of manufactured nanomaterials.
It appears given the import of the above that several key matters in regard to the safety of nanomaterials are effectively in a state of flux. Clarification has yet to be reached it seems as to how to approach the whole matter of testing, and effective toxicology testing can be assumed central to the whole safety debate and vital in order to determine the nature of regulation which will be necessary to safeguard societal and environmental interests. It is suggested by some involved in the testing debate that existing methodology remains somewhat inadequate given the unique nature of nanomaterials, by others that toxicology testing is applied using unrealistic exposure models. The two-and-fro can often complicate the issue for impartial observers. Against this backdrop a renewed push to commercialise nanotechnology continues unabated with increasing number of nano-enabled products and applications entering the marketplace.
There are a multitude of organisations and agencies engaged in the ongoing testing, registration and regulation debate. In the context of regulation generally, we cite the case of two agencies central to continuing progress in the area of official regulation. These are the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) agency in the EU, and the EPA (Environmental Protection Agency) in the United States. An extract from the Official Journal of the European Union REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning (REACH) pointed to regulation as follows:
"Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances."
Despite the obstacles and difficulties, significant progress is being made to address key concerns; safety, testing, reference materials and the wider commercial structure of nanotechnology. Clear evidence points to much more needing to be done with various regulation agencies grappling to overcome a plethora of issues against the backdrop of an increasing, if somewhat fragmented, use of nanotechnology in a commercial and consumer good context
Analysis of the current focus of debate on Environment, Health and Safety (EHS) issues pertaining to nanomaterials can enable insurers to gather an appreciation of the arguments in favour or against certain regulatory proposals and the existing structure. While there have been immense progressions made in establishing a global network to support nanotechnology, the first matter to consider is the fact this network owes its origins to the input of science, academia, social researchers and government, constituents who are not inclined by nature to focus on the cut and thrust of daily experiences in the commercial world proper. The debate over regulation once again is themed by reference to issues surrounding the safety of nanomaterials and consumer rights, linked to but not focused on any consistent analysis of what may be needed in terms of regulation to satisfy commercial considerations. That is not to deflect from the importance of safety and consumer rights, but rather to point up the fact calls for any application of any market mechanism to act as a catalyst to unite competing interest (Upstream/Downstream interest in nanomaterials, consumers and regulators) to view any advantage to themselves in adopting a traditional self-regulatory approach in support of official "top down" efforts to regulate, has not featured large in the context of the debate thus far.
The fact traditional checks and balances introduced by application of market forces has not focused high on the regulatory agenda can in some respects be assumed a weakness in determining a more practical regulatory structure.
Aspects as to what form of framework which may be needed to advance the commercialisation of nanotechnology are rarely the subject of protracted analysis. Outside observers remain somewhat perplexed as to how any discussion regarding a suitable regulatory structure can achieve the desired outcome without reference to the commercial structure of nanotechnology. It can be accepted that the issue of safety rests at the heart of determining whether nanotechnology can be commercialised at all and this debate must of course continue. However, what appears somewhat obvious, or at least we can reasonably assume as obvious is the fact any industry reliant on materials that are neither insured fully or available through a market mechanism of some sort will inevitably struggle to gain commercial traction.
The debate concerning safety and regulation should be encouraged to include a much more detailed analysis of the proposed commercial interface or end point.
The efficient functioning of the internal market for substances can be achieved only if requirements for substances do not differ significantly from Member State to Member State.
The above extract again cited from the "Official Journal of the European Union, the internal market" but in nanotechnology there is as yet no organised internal market or mechanism capable of delivering into being more universal specifications of nanomaterials or fuctionalised variants. With SWCNTs for example each supplier tends to manufacture a different variant from the other to suit a particular customer base or application. While this is not uncommon, it is in the context of a raw material rarely sustainable as a key requirement for any raw material is its availability from a multitude of sources as opposed to a singular source.
Nanomaterials are therefore easier to progress in a regulatory and commercial context should supply participants develop toward a series of more uniform specifications. Establishing a means to accelerate movement in this direction will be gradual, and more likely somewhat protracted in the absence of a centralised market structure, used by many other industries to quantify their respective raw materials bases. The very multi-disciplinary nature of nanotechnology in some respects acts as an obstacle toward the development of a central market where trade standards and grading of nanomaterials specific to particular applications can occur.
An emphasis on nanotechnology as an alternative methodology in chemistry at the expense of its relevance to engineering, metals, agriculture and so forth means a natural commodity exchange ethos does not come to prominence as it should in certain cases. The chemical industry by and large remains an in the trade industry, having not developed an open market, exchange process in itself a commercial price insurance handicap, whereas the metals, agriculture and engineering sectors have long used the open market process to structure materials standards and trade practices. While not all nanomaterials are commodities, as more functionalised or tailored nanomaterials may prove one-off customer requirements as opposed to more uniform grades, they are nonetheless surely in a commercial context, raw materials. We move then to ponder what may be required to make wider commercial uptake possible and how the entire effort at commercialisation remains inextricably linked with the issues of safety, availability, price transparency and independent verification.
The observance of defined standards is not new in the front end of commerce where litigation threat consistently manifests where corporate negligence is proven. Consumer rights are viewed as a commercial imperative. These rights are enshrined in law along with work place standards in Health & Safety, and considerations for societal and environmental safety. This axis of standards inextricably links to determining the ability of the insurance industry to engage in any indemnification process.
Perceptions, real or imagined, as of any limitation in observance of these standards, compel politicians and various regulatory agencies to act out of obligation.
The latter point is supported when we consider the observations below:
The 2010 nano inventory, published on 25 October by the European Consumers' Organisation (BEUC) and the European Consumer Voice in Standardisation (ANEC), found 475 products containing nanomaterials compared to 151 the previous year.
Monique Goyens, director-general of BEUC, said products were going on sale "without assessment of their claims or the risks these nanomaterials may pose to public health".
She referred to the situation as "a game of health and safety roulette" and reiterated BEUC's support for the Belgian Presidency's initiative on the mandatory traceability of nanomaterials.
ANEC Secretary-General Stephen Russell said that "in the absence of independent safety assessment, and given the unconfirmed nature of the claims, we believe action needs to be taken urgently".
Nanotechnology appears to be presenting a commercial case of "nano-mania" of late to politicians, interest groups and the consumer with a rush to bring goods onto the market without observance of what are held as normal commercial standards.
The picture does appear confusing further when we assess a recent comment from Dr Andrew Maynard, chief science advisor to the PEN project who have collated an inventory of some 1,000 products claimed by manufacturers to contain nanotechnology:
He said around 800 products have been identified online, with the bulk of these found in the health and fitness sector, but that few of these pose a potential health risk.
However, he is concerned that controversy surrounding nanotechnology, some of which, he says, is not grounded in scientific fact, has led manufacturers to remove any mention of nanomaterials from their products.
"We have seen some companies drop the 'nano' claim while continuing to use nanotechnology. This suggests nanotechnology is going underground," he said.
Harald Throne, researcher at the National Institute for Consumer Research in Norway, echoed concerns that companies may be becoming less inclined to highlight nanomaterials.
He searched a website run by a major international cosmetics company, using keywords like 'nanotechnology' and 'nano', to estimate how many products contain nanotechnology. Throne's search turned up 29 products in 2007, but when he repeated the same exercise recently, there were zero hits.
This, he said, suggests that companies may now view 'nano' as a negative label rather than an added value.
Sue Davis, chief policy officer at UK consumer advocacy group Which?, said data was limited, and expressed concern that companies are reluctant to engage with consumers on the issue.
"We have to distinguish between marketing hype and real uses of nanotechnology," she said, adding that her organisation had found it difficult to extract reliable information from industry. She said Which? conducted a survey of 67 cosmetic companies but received information from just eight. All eight respondents reported using nanotechnology in sunscreen. "However, if you go online you can find products advertising carbon fullerenes in anti-ageing creams and nanosilver in toothpastes, despite the potential toxicity associated with these substances," she said.
Davis called for mandatory reporting to combat the lack of information in this area, as voluntary codes do not work.
In a response by the Nanotechnology Industries Association, Steffi Friedrichs, director of the association, said the industry has been upfront about its use of promising new technologies and that companies go to great lengths to ensure products are safe.
She pointed to confusion about the definition of nanotechnology, with some NGOs defining 'nano' as materials smaller than 300 nanometres, while the industry uses the definition of less than 100 nanometres.
"Varying definitions leads to claims that the industry is not open with information. But nobody is lying and nobody is misleading the public or authorities. Let's agree on what we're talking about and work together to inform consumers."
While there are disagreements as to the shape any official regulatory structure should take, there is nonetheless a common acceptance withing the nanotechnology community and in official regulatory circles that regulation of some variety is required. Studies to continue toxicological assessments are continuing and in the case of nanotechnology will prove an ongoing undertaking. Knowledge resource can be made avilable to official regulators as they grapple with the issues of how to balance need to safeguard societal interest with the fundmental right to pursue compliant commercialisation. Commercial tools are coming onstream to enable the introduction of market checks and balances to be applied to nanomaterials which in turn opens ups the ability of insurance and capital to value the more prominent nanomaterials used in commerce today.
When we arrive to assess the clarifications required by the insurance industry to engage to underwrite risk in the context of nanomaterials and nanotechnology in general, positives are emerging.
Insurers remain disposed to approach risk in nanotechnology in much the same manner as they would approach any other industrial sector. Networks are available to it to clarify both the many positive applications inherent in nanotechnology and limit the potential adverse exposure to risks.
The process of interaction will invariable prove ongoing and for this reason insurance companies are encouraged to use the various state sponsored nanotechnology platforms to gain an impartial insight and to use the developing self-regulatory approach in the exchange of nanomaterials as a working "hub" to introduce what are commonplace standards and value options in the context of other, more familiar materials.
Nanotechnology provided it can continue to focus on first generation advances has nothing to fear from opening up to official regulation agencies or from embracing the concept of market checks and balances in the allocation of raw materials. The interactions can go some considerable way to enlightening an already burdened regulatory infrastructure and provide the ability to attract the commercial supports necessary to transform an SME (Cottage stage) concern to commence a structured path to sustained commercialisation. This holds a particular positive in respect or product application areas highlighted earlier in this report.
Nanotechnology as it progresses at the first generation stage is creating more functional materials, which can compliment but in many cases move in time with capital support to replace existing materials and other products classed as a commodities.
Use of nanomaterials in more simple terms will create materials that last longer, that hold better qualities of wear, tear and abrasion.
How this fits with an industrial and consumer society inured to a culture of "disposable" product lines from automobiles to polymers poses benefit on the one hand tempered with disadvantage to industries that do not move with the times. Clear risks to capital are represented should nanotechnology be permitted to develop without effort to adopt a comprehensive phased-in/phased-out process of structural realignment. Issues concerning remediation, recycling and a whole raft of other issues require the insurance industry to address.
At a socio-economic level, how will nanotechnology affect commodity dependant nations? Would it be likely to instigate social and economic upheaval as existing commodities fell out of favour, or can a mechanism be introduced to manage a smooth transition across the global economy. What are the ramifications for the computer industry?
Challenges posed by Nanoscale Technologies
The challenges posed by commodity dependence, traditional or otherwise are myriad and complex. In relation to nanotechnology striking a balance between raw commodity inputs and end product efficiencies depends on appropriate transition periods and the management of raw inputs that feed knowledge based economies. All knowledge based economies require these scarce inputs which in turn drive international energy agendas. A new means of production, effectively what nanotechnology equates to, with the ability to evolve a new industrial revolution offers many national opportunities, but equally many threats.
Nations with capabilities to create or adopt and consequently diffuse the technology stand to amass wealth. These types of countries are the knowledge driven economies. In comparison less developed countries usually poor, lack inventive skills abilities and production knowledge, are economies generally anchored on minerals extraction and agriculture. If knowledge based economies are to flourish through nanotechnology, striking the right balance between commodity dependant countries and commodity-exporting countries will be critical to ensure global economic stability.
Nanomaterials producers and end product innovators all require raw source materials in the form of ore, precious metals, hydrogen, methane, many of which are exported from lesser developed countries to knowledge driven economies to be further synthesised into nanomaterials. The new economic drivers are energy agendas with increased demand envisaged for energy efficient devices. These new drivers of commerce will also power the next generation of solar panels, electric vehicles, thin films, super conductors, and fluidic devices, and on gaining traction will act to push exiting nations/business to change or face threat economic instability. What is important is the striking of equilibrium between new power houses dependant on supply of vital and scarce source materials.
A key difficulty relates to the fact the more study is directed toward nanotechnology and potential socio-economic aspects, the more profound potential benefits and invariably displacements of some variety or other spring to mind. We should bear in mind the last real experience we have in Britain of what we refer to as "socio-economic displacement" occurred during the early stages of the Industrial Revolution where the emergence of factories witnessed incident of violence and subversion directed by those dependant on continuance of the cottage style of economic endeavor.
The fact to perhaps acknowledge is one where the memory of societal and economic upheaval is distant and not immediately fresh in the minds of the developed commercial world.
How Nations Prepare?
When INSCX exchange has suggested the implementation of a comprehensive Phased-In/Phased-Out process of structural embedding of nanotechnology, we refer to the integration of first generation nanotechnologies in the first phasing. Clearly change will introduce a requirement for existing industry to adjust and new industries to emerge. We can cite the analogy of a technology company that must move with the times and not structure itself into a straightjacket where it cannot move with the times.
The following quote extract taken from a report compiled by the Institute for Global Futures summarises some of the potential scenarios which nanotechnology is now presenting or likely to present. When we consider the report is dated from 1999, we are invited to assess where we are now some 11 years later. Is there a case to suggest we have entered into today what the author refers to as the "Bumpy Road" scenario? There are a number of other Fate analysis studies compiled, but this one summarises the general point.
"Recent developments in emerging technology and its impact on business and economics would indicate that forecasts are less than accurate in predicting the future. Few would have accurately forecasted innovations such as of the Internet, wireless communications or the mapping of the Human Genome.
Also, there have been numerous wild forecasts that have historically seemed more like science fiction than fact. Predictions about nanotechnology have fueled the imagination. Much of this is still imagination but the future looks promising. Nevertheless, new innovations in technology are reshaping the global economy at a dizzying speed. It would be prudent to consider the possible economic outcomes given the accelerated emergence of advanced technology.
As Nanotechnology may translate into the sustainability of nations, organizations and entire industries, effective readiness, preparation and planning for change becomes vitally important."
Summary of key issues facing Insurers
1. Lack of clarity caused by a "Fog" of confusion or information overload
2. Environmental, social and economic risk warranting nanotechnology disclosures and strategic planning for current and immediate change
3. Existence of standard risks and "long-tail" risk concerns holding potential to create a basis for claims from workers, consumers and environment through class action litigations
4. Lack of uniformity in base nanomaterials and traceability through the supply chain sequence
5. Immediate need for capital to commence realignment to prevent displacement of socio-economic fabrics
6. Lack of a defined Cradle to Grave approach in the sourcing, use and reverse referencing of nanomaterials up and down the supply-chain to identify liability cut offs
7. Possible incidence of fear litigations
8. Global nature of nanotechnologies creating potential for disparity in adherence to regulatory standards
9. Need for greater sharing of knowledge base with official regulators
10. No option but to embrace nanotechnology for fear of losing out competitively or remain exposed to unknown risks
While the ten points listed all point to potential problems there are in each case means available to arrive at solutions using the combination of professional experience retained by insurers supported by a greater adherence by the nanotechnology business community to driving a process of self-regulation.
Self-regulation in turn can and should be supported by official "top down" regulations as this collaboration will ensure effective regulation by consent of vested industry participants.
The insurance industry has a proactive role to play calling for clarification on issues central to enabling any ability to indemnify or exclude coverage for potential liability arising through further evolution of nanotechnology. However, to be successful nanotechnology must in a commercial context meet insurer's half-way as it were. Should move be made in this direction the networks created by science, academia and government to structure the hierarchical aspects of nanotechnology can be tapped into to enlighten and inform competing commercial interests.
Useful reference points include in the EU area, NANOfutures, Minam and CORDIS. Links are provided below:
The following extract is cited from CORDIS by way of providing a general description as to the purpose and rational of the platform.
"The risk assessment of engineered nanomaterials has become the focus of increasing attention. To date the widely accepted view is that there are many unanswered questions, although a high number reports have been published discussing the potential environmental and health risks associated with the manufacture, use, distribution and disposal of nanomaterials. The European Commission aims at reinforcing nanotechnology and, at the same time, boosting support for collaborative R&D; into the potential impact of nanotechnology on human health and the environment via toxicological and ecotoxicological studies. Commission regulatory activities: The Commission is performing a regulatory inventory, covering EU regulatory frameworks that are applicable to nanomaterials (chemicals, worker protection, environmental legislation, product specific legislation etc.). The purpose of this inventory is to examine and, where appropriate, propose adaptations of EU regulations in relevant sectors. Preliminary findings indicate that the regulatory frameworks in principle give a good coverage based on the fact that different aspects of production and products are at the same time subject to various Community provisions. However, many of the knowledge gaps (toxicity thresholds, test schemes etc) will need to be addressed to ensure implementation."
This is an extensive network established. Covering more then 600 members from 36 countries and continuously growing, the platform acts as an exchange forum for the topics of industrial micro and nano manufacturing: materials, equipment, components. It aims to support industry growth in this new field by the development of a common R&D and education strategy and by enabling close cooperation of e.g. SME, Industry, Research Institutions, NGOs and Public Bodies.
In relation to CORDIS attention is drawn to the link to the Compendium of Projects in the European NanoSafety Cluster - March, 2010 available using the CORDIS link:
This report provides detailed summary of efforts to assess wider Health & Safety issues arising from application of nanotechnologies. Links provided to various FP7 and FP6 projects in these and areas of toxicology, environmental pollution and so forth are useful information access points.
Readers are advised also to view the Nanotechnology Action Plan Link provided below:
ELSA - Ethical legal and Social Aspects
These networks are complimented by established consultancies in nanotechnology and wider private networks such as those developed by SAFENANO, IOM, INSCX exchange, the NanoCentral Alliance, NanoReg, Cientifica to name but a few.
It is important to appreciate that initiatives conducted through FPs are accompanied by measures that identify, analyze and communicate Ethical Legal and Social Aspects (ELSA) and remain geared to reach good governance in nanotechnology, an obvious benefit to insurers. Another useful information portal proves those provided by the UK based Institute of Nanotechnology, an organisation operating as a charity to further understanding in nanoscience.
The Institute of Nanotechnology (IoN) was founded by Ottilia Saxl in January 1997. It is a registered Charity, whose core activities are focused on education and training in nanotechnology. It grew out of the Centre for Nanotechnology, part funded by the DTI through the UK's National Initiative on Nanotechnology (NION). The Institute was one of the world's first nanotechnology information providers and is now a global leader. The Institute works closely with governments, universities, researchers, companies and the general public to educate and inform on all aspects of nanotechnology. It also organises various international scientific events, conferences and educational courses that examine the implications of nanotechnology for industry, society, health, energy and the environment, and the disadvantaged communities across the globe.
Source: IOM: www.nano.org.uk/aboutus.htm
6. Nanotechnology and Food
An abundance of material has been written assessing the use of nanotechnology in the food sector. In January, 2010 the UK House of Lords Select Committee on Science and Technology published a comprehensive study which is available for review using the link below:
Commenting on the House of Lords report, Lord Krebs, who chaired the Science and Technology Committee's inquiry into Nanotechnologies and Food, said: "The use of nanotechnologies in food and food packaging is likely to grow significantly over the next decade. The technologies have the potential to deliver some significant benefits to consumers but it is important that detailed and thorough research into potential health and safety implications in this area is undertaken now to ensure that any possible risks are identified. The Government and Research Councils have a responsibility to ensure that this research takes place and must now take a proactive approach to identifying and funding appropriate research.
It makes the following recommendations:
* Greater transparency from industry regarding its use of nanotechnologies and nanomaterials in food R&D;
* Government and Research Councils to adequately fund research into potential health and safety risks arising from the use of nanomaterials in the food sector (in particular that research is commissioned which focuses specifically on the behaviour of nanomaterials within the body and particularly the gut);
* Creation of a public register of foodstuffs and food packaging that contains nanomaterials, to be maintained by the Food Standards Authority;
* Specific mention of nanomaterials in food legislation, and that the UK Government work with other EU nations to clarify what is meant by the phrase "properties that are characteristic to the nanoscale" in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise;
* Tighter controls on imported foodstuffs and dietary supplements (particularly those available over the web), including new testing regimes.
However, it did not recommend labeling for all foodstuffs containing nanomaterials, a path advocated by a number of pressure groups and NGOs.
In the wider European context, the European Food Safety Authority (EFSA) published its findings on nanotechnology in food in March 2009. This report led to a request from the European Parliament to the Commission on amendments in regulatory provision for foods including:
Introduction of a specific definition of nanomaterials, labeling and stricter requirements for risk assessment of products containing nanomaterials.
Source: Institute of Nanotechnology, January, 2010
Other Perceptions - Responsible NanoForum
There is lots of speculation about how nano could help enhance foods, from futuristic ideas about foods that change to respond to your nutritional needs or taste preferences - to more down to earth applications - such as better ways to add flavours, create textures or enhance nutritional benefits.
At the moment, though we can't be certain, there seems to be very little use of nano in food in the UK, though many companies, large and small, are researching what it could do. The known uses are confined to wrapping nutritional ingredients into nano-sized parcels for better absorption in food or mineral supplements, though nano is likely to be used more widely in packaging.
On a fundamental level, foods like milk have natural components on the nanoscale, while processes such as flour milling, some cheese making and certain sorts of food processing, which have been used safely for many years, can in some forms also be described as nanotechnologies. This is what adds to the confusion that exists about nano in food.
But we use the term today to mean when we deliberately use tools, processes, and materials that work at the nanoscale to develop new, and hopefully improved food products, e.g. with less salt or fat, but tasting like the real thing. Some of these are likely to be an extension of existing technologies and others more complex.
Source: Responsible nanoForum "Nano and Me"
7. Public Engagement
Public engagement designed to increase familiarity with nanotechnology continues to make inroads lending itself to a situation where for the younger generation science and engineering has become an attractive field of study against a previous bias in favour of following service type educational studies. While much more work needs to be done of course to formally introduce nanotechnology into the schools curriculum, progress is being made gradually. Within the European Union, CORDIS, the Nanotechnology Platform of the European Commission provides a defined summary of available educational supports and "Communication and Debate" initiatives. The CORDIS website can be accessed using the link below:
In February 2010, House representative David Wu has introduced the Nanotechnology Education Act (HR 4502 IH) with the goal of strengthening the capacity of eligible institutions in the U.S. to provide instruction in nanotechnology. The purpose of this bill is to strengthen the capacity of United States secondary schools and institutions of higher education to prepare students for careers in nanotechnology by providing grants to those schools and institutions to provide the tools necessary for such preparation.
In the UK a substantial web interface was launched late 2009 to provide an easily accessible information pool to the public to gain familiarity with nanotechnology and engage in open debate. Information on a variety of topics from Products, Safety, Regulations, Ethical and Legal to useful insights in use of nanotechnology in food are provided in simple easy to read terms.
"Our aim with nano&me is to provide balanced information about nanotechnologies and be the hub of debate for everyone to discuss the important issues which arise from its use."
Nanojury was meant as a contribution toward presenting a non-specialist perspective on dilemmas arising in a socio-economic context from emerging nanotechnologies. The site can be accessed at;
Nanotechnology for Schools (Cambridge University)
Recent surveys show that most European citizens have a limited understanding of the potential and risks of Nanotechnology. This needs to be rectified if the European public is to contribute positively to future decision-making about the use of Nanotechnology. With this in mind the Nanoscience Centre has recently become part of an exciting new initiative. The purpose is to promote the interest and enjoyment of Nanotechnology to young people and also encourage their participation in dialogues about the ethical, legal and societal aspects of Nanotechnology. The initiative is supported by NANOYOU, a network of excellence backed by the Seventh Framework Programme from the European Commission. This will include school visits, interactive lectures, seminars, open days and taking part in relevant festivals.
A groundbreaking poll of 1,001 U.S. adults conducted by Peter D. Hart Research Associates and the Project on Emerging Nanotechnologies (PEN) published September, 2009 found 90 percent of Americans think that the public should be better informed about the development of cutting-edge technologies. The survey reported there to have been only minor shifts in awareness of nanotechnology over the past four years. Today, three in 10 Americans say they have heard a lot or some about nanotechnology, the same proportion measured in 2006.
The PEN Project also provides an inventory of nano-enabled products.
"After more than twenty years of basic and applied research, nanotechnologies are gaining in commercial use. Nanoscale materials now are in electronic, cosmetics, automotive and medical products. But it has been difficult to find out how many "nano" consumer products are on the market and which merchandise could be called "nano. While not comprehensive, this inventory gives the public the best available look at the 1,000+ manufacturer-identified nanotechnology-based consumer products currently on the market.
In the Consumer Products Inventory there are currently 1014 products, produced by 484 companies, located in 24 countries.
Several business networks exist to promote nanotechnology. Notable semi-private organisatons include the Nanotechnology Industry Association (NIA), Nano Business Association (US), and charitable organisations such as the Institute of Nanotechnology based in Edinburgh which traces its origins back to 1994. Across Europe and worldwide similar semi-private associations exist supported by state-sponsored networks such as Minam and NANOFutures (EU only). A key deficiency in the semi-private industry association structure remains lack of sector or material specialisation although Carbon nanotube and nanosilver have established fledgling associations. Many nanomaterials remain effectively bunched together into singular associations which of course limits commercial interactions particular to individual materials, or have allied themselves to wider, established associations where nanomaterials reserve only a watching brief in the wider scheme of things.
The process is gradually changing although recent workload for many associations has again had to focus on regulatory issues, always a time consuming affair. Another point to accept as a constructive criticism is that often practical knowledge of the "real world" of business can be found lacking not by design or intention, but as a reflection of the scientific and academic origins of nanotechnology where emphasis has tended to celebrate innovation and research as opposed to commercial deliverance. Again, the process is changing, but will take time and require the cushion of financial support in some shape or form to fund recruitment of business talent.
1. Key objectives in raising public awareness are suggested as requiring to introduce nanotechnology into the formal schools curriculum and the establishing of teams of consultants recruited from business and educated in nanotechnology for recirculation as advisors to existing business and their respective networks.
2. National government cannot be expected to shoulder all the "heavy-lifting" educating the business world, nanotechnology at commercial end points must work to sell itself at grassroots level.
3. Individual nanomaterials need associations where specific material suppliers can interact with potential buy-side interest under the auspices of existing umbrella associations if necessary to promote nano as a safe and value-for-money alternative.
4. Nanotechnology must work to present to the public its own measures as an industry to promote adherence to essential standards in safety and commercial convention. Networks such as NANOfutures exist to help guide SME nanobusiness in these and many other areas designed to increase uptake.
To follow up on all past and present EU public engagement exercises follow the link below:
"Nanoscale silver provides an excellent example of the challenges facing the Environmental Protection Agency (EPA) in making risk-based regulatory decisions. Silver has been used for millennia and is already registered as a pesticide yet the agency has spent more time on this one substance than any other nanomaterial despite a rather vocal response from the public touting its medicinal properties rather than its hazards."
Source: NanoReg (USA), 2010
"Oversight consists of obtaining risk information and acting on it to prevent health and environmental damage. An underlying premise of this paper is that adequate oversight of nanotechnology is necessary not only to prevent damage but also to promote the development of the technology. The United States and Europe have learned that oversight and regulation are necessary for the proper functioning of markets and for public acceptance of new technologies."
Source: (PEN) Oversight of Next-Generation Nanotechnology, April, 2009
While resolution on the matter of regulation will take time, several initiatives are underway within the nanotechnology community itself to move to devise a self-regulatory framework as many other industries have done in an effort to guide official regulators to introduce a practical legislative template as they continue deliberations. Meanwhile nanoscience and nanotechnologies will continue to evolve.
Immediate focus within the United States and elsewhere has come again to focus on regulatory issues of late, in particular the lack of a defined regulatory framework, driven by agencies such as the EPA (Environmental Protection Agency). Within the European Union area increasing concerns are being voiced by members of the European Parliament, some calling for outright bans to be implemented on nanomaterials ranging from nanoscale silver to Multi-Walled Carbon Nanotubes with these materials added in 2010 to the EU Restriction of Hazardous Substances Directive (RoHS), to calls for blanket product labeling of all nano-enabled products.
To many within the scientific and nanomaterials community regulatory moves of late are deemed punitive if not overtly short-sighted and based on suspect assumptions. Product labeling or what INSCX exchange described in the course of a recent statement outlining industry options to implement source to end-product traceability, were dismissed as an effective "Brand Nano", a position further supported as we have alluded to previously by the labeling suggestion being proven by the Nanotechnology Industries Association as impractical in the case of many nano-enabled devices such as transistors in computers.
The issue of regulation can cloud the assumption that somehow nanotechnology will stand still until the issue is clarified one way or the other. Within the nanaotechnology community the OECD Working Party on Manufactured Nanomaterials (WPMN) established in 2006 is viewed as a key sector driver. While of course clarity on regulation will enable smoother transition toward sustained commercialisation, clear concern has been expressed in many quarters suggesting regulatory changes, if any need to be practical.
An over-reliance on traditional "Round Robin" materials referencing and application of "overdose toxicology testing" is not regarded by the nanotechnology community as a basis upon which to structure an effective regulation, compounded of late given recent calls for the base measurement of nanomaterials to be increased from the 100nm benchmark to 1,000 nm.
"In recognition of the need for coordinated testing methodology and reference testing materials in order to duplicate and compare test results, the WPMN Guidance Manual for the Testing of Manufactured Nanomaterials was published in 2009, which includes an index on Alternative Methods. A Preliminary Review of 115 OECD test guidelines has shown that many tests are suitable but that in most cases, modification will be needed in order to isolate relevant nanomaterial characteristics. This point is critical as the findings indicate there are only a few standardized tests that are adequate for testing nanomaterials as currently developed, and that new nano-specific tests must be developed quickly in order to ensure effective characterization.
Some criticize regulators for using science alone to justify normative policies, rather than a broader set of tools such as cost-benefit analysis. Good policy flows from a coherent synthesis of many scientific, economic, legal, and political considerations, but for health and environmental issues, science must always serve as the basis for understanding.
The complexity of nanoscience challenges our need to act appropriately to reduce potential while acting intelligently to assess potential risks."
Source: Extract cited from "Global Efforts to Fully Characterize Nanoparticles: Scientific and Regulatory Implications" courtesy of Nina Horne, invited expert to OECD Working Party on Manufactured Nanomaterials
Clarification is needed on agreed materials referencing and testing methodology, but in the context of nanomaterials there are some common characterisation and materials measurement techniques employed, which are universally applied. Much more work needs to be done of course as indicated by the observations made in the cited extract above. A key difficulty relates to the lack of significant movement toward a more universal supply specification, although this is gradually changing especially in the context of the 14 most common nanomaterials identified under the Sponsorship Programme for Testing Manufactured Nanomaterials of the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation of Economic Cooperation and Development (OECD).
Within nanomaterials there is currently a lack of uniformity in material specification from one supplier to the other even in cases where individual manufacturers supply the "same" nanomaterial. This is often true for the 14 materials identified as more widely used. While a multitude of variants of raw materials or commodities is not uncommon (grades of crude oil for example), in the context of nanomaterials we are presented with a complexity of materials that can be the same only in name as individual physio-chemical properties can vary enormously.
In many respects this is a by-product of any emerging raw materials base which often commences commercial existence where each supplier often I the same material "markets" their product as different from the competition or more special in some way or form. This disposition is perfectly natural in the absence of a centralised market where there is no venue to provide a catalyst for the supply base actors to accept a commercial rationale for movement toward a series of universal grades or variants.
It can be argued that raw materials need to adopt more universal specifications to gain traction as they will be needed in such quantities via an efficient mechanism to enable a "buy and forget" mentality to develop in the minds of purchasers. The difficulty the industry appears to retain though is a position which suggests acceptance of nanomaterials as raw materials or commodities, and it would follow, possessed of more universal specifications, will somehow "dumb down" the price the "nano-commodity" commands. The word commodity is being equated with translating to a material somehow "less-special". While the assumption fails in many ways to appreciate the fact a material is exchanged as a commodity has no real bearing on price, but rather signals growth in supply capacity where price is a factor determined by perceptions of usefulness balanced with cost input levels to produce and supply, this ethos of individualism poses immense difficulties for regulators going forward.
Regulators are faced with having to decide test methodology which can account for multiple if not infinite variants often of the same bulk material. This ensure a "general housing" approach where standards in test methodology can be applied to each and every variant of nanomaterial to assess toxicology could involve decades of research and development against the backdrop where the variants have been in use during the intervening period without their being subjected to any appropriate means of evaluation.
Risk to insurers could prove catastrophic particularly "long-tail" risk regardless of whether they moved to extend coverage to insure the individual material. The fact any material was in circulation through the supply chain without appropriate test methodology would run the risk of opening a "Pandora's" box as it were of potential claims. When we conclude that existing Round Robin and toxicological methodology remains taxed when faced with the area of nanomaterials, the critique is based on an impartial as opposed to loaded assessment of the reality faced.
It is suggested a great deal of evaluation of individual nanomaterials materials will require the application of computer generated modeling analysis based on scenario appraisals. A number of scenarios formed a basis for evaluation through the Nanologue project which stated as its purpose:
The scenarios aim at establishing a deeper understanding on the societal benefits and risks of NT-applications in the view of civil society representatives and researchers. By showing plausible futures and rationalising the diversity of opinions presented during interviews and stakeholder workshops they may inspire long term policy development. The scenarios are explicitly not predictive, but should be used as a qualitative planning and communication tool.
Key questions remain as to whether access to sufficient computer capacity to conduct various scenario modeling appraisals can be made obtained. In the interim, commercial mechanisms are suggested as having a key role to play. The application of open market techniques, where suppliers and buyers come together to agree what is to be exchanged can act to accelerate a position where society and business is not faced with the prospect of widespread use of a near infinite number of materials for decades before any means has developed to assess the individual safety of each material.
The mechanism cannot solve the problem, but can force the issue of toxicology to be a matter assessed against the backdrop of application based materials, individual grades or specifications for want of another term.
Evidence of Thawing
There is some evidence of a thaw in the perception held by the nanotechnology community that commodity equals a fall in price or margin. The thaw however has emerged more by default as opposed to design in response to the recent labeling and ban debate. For example, when we assess the comment attributed to the Nanotechnology Industry Association (NIA) cited in response to calls from Euro MEPs for labeling, or banning of particular nanomaterials, the NIA went on to suggest:
"The properties of each material must be evaluated according to application, and on a case-by-case basis."
Source: Steffi Friedrichs, Director NIA
There can be assumed a rational logic to the import of the response calling for the proposed regulation change to be applied on a specific application basis. For example, if we take the analogy of an acid, another hazardous material. How is this regulated? Acids used in batteries are permitted, whereas it is not permitted for sale to ordinary members of the public as something they can "fool around with" as it were. If we follow the import of the NIA response a little further, we can reasonably conclude specific applications which use nanomaterials as an input will require these nanomaterials to be made available in more uniform specifications. This suggests individual grades of nanomaterials will emerge (Electrical or filler grades for example). It can also be suggested the various grades in order to command critical mass in the ability to supply to potential industrial levels of demand will need multiple as opposed to singular sources of supply.
All evidence points to the emergence of multiple nanomaterial sources of supply to defined "Grades" as a logical commercial development. This in turn will make the task of devising toxicology testing methodologies much easier although difficulties are not underestimated. Then process capable of accelerating movement will require a coming together of supply interests across nanomaterials supplier base as opposed to the base continuing to operate in a fragmented, individual supplier manner. The question then becomes, assessing what mechanism can best accelerate the process.
One method used in the past has been the commodity exchange process. We know the INSCX exchange project scheduled to launch later 2010 will act as the nanomaterial version of a commodity exchange and it is proposing to list various grades of nanomaterials. This development in turn could open up an opportunity to enable individual nanomaterials suppliers to act in syndicate to develop the critical mass necessary for industrial-scale uptake. In turn this could make the task of devising ongoing toxicology somewhat more focused on specific grades peculiar to specific applications.
The incorporation as proposed of Downstream Audit Sequencing (carrying forward the trade transaction ID) and Contingency "Shut-Down" (applying a % levy to all exchange transactions opens up further possibilities to square off the traceability issue. These are referred to subsequent as our focus here relates to how moves to a more universal number of material specification can make issues relevant to EHS somewhat easier for regulators and insurers to manage.
By "long-tail" risk we refer to risk which becomes manifest in the future. The most recent experience of "long-tail" risk in recent years proved the incidence of a mass of claims arising as a consequence of asbestos being shown to be harmful. Nanomaterials we suggest in the interests of prudence must be assumed potentially capable of creating similar long-tail risk scenarios. To suggest otherwise would be wholly inappropriate at this stage, but this in turn should not also be construed as a statement suggesting long-tail risks are inevitable. Whatever, most observers can agree the very fragmented nature of the EHS/commercial process in nanomaterials merely adds to compounding a potential difficulty. This would point to it being practical in the first instance to commence a process where the industry can move itself to quarantine potential for the emergence of long-tail risk scenarios. Fragmentation in structure must then be resolved.
Nanomaterials are and will find more applications and uses in the years ahead. Construction, engineering, pharmaceutical, chemicals, metals etc. The list is infinite. More universal specifications of materials where the supply base has developed a critical mass will help but not eliminate potential risk. That stated it remains possible surely to mitigate the extent of risk.
To progress the EHS solution, the entire process we suggest must lean toward being an interlocking or "top-to-bottom" affair. Exact material specification or grade, agreed testing methods, quality assurance, price discovery, nominee reporting, the ability for trade counterparties to trade compliant but anonymously, price hedging supported by commercial insurance are all facets of the trade process underpinned by the formal commodity exchange process.
While movement toward more universal grades in whatever manner we can assume a positive, the "bedding-down" of nanomaterials into defined grades commanding sustainable commercial traction will take time. The INSCX process could speed this development. However, we have noted many traditional testing methodologies require further development, and in all likelihood will be an ongoing affair. This very fact alone can means "long-tail" risks may be minimized but not eliminated entirely, a factor which can be reflected in the wording of insurance coverage and factored in the level of premium.
The traditional application of Round Robin methodology in referencing and characterisation in the context of nanomaterials most participants in nanotechnology accept as incapable of meeting the challenge going forward.
For this reason alone there will need to constant consultation between INSCX as the commodity exchange for nanomaterials, effectively consultations between trade buy and supply side interest, international standards agencies such as the ISO, independent materials measurement agencies and hierarchical bodies such as the OECD going forward.
The role of INSCX will be to assist streamline the ongoing consultations, providing insurers with definitive proofs. In addition definitive working lines of contact have already been established with the relevant agencies to determine exacts in standards, characterization techniques and materials referencing already. Insurers themselves obviously have a part to play, but can take some considerable comfort from the fact a process already exists to address existing limitations and an interlocking venue created by INSCX exchange where they can air their concerns going forward.
There is evidence to suggest a gradual movement toward more universal material specifications across the supply base. Ti02 for example, of the 14 more widely used nanomaterials, where trade is cited as equating to some 2,000 metric tones annually, is clearly moving toward more universal specifications across the supply base. This shift toward universal specifications can make the ongoing task of
The whole area of Environment, Health and Safety (EHS) standards in the context of nanomaterials is continually evolving. The United States is the global leader in nanotechnology-related EHS research and development. Some US$480m is allocated to be invested through the National Nanotechnology Initiative (NNI) between 2005-11 to conduct further EHS and toxicology studies.
Comparative figures for the EU region come in around US$100m. While there are concerns overall as to potential safety issues in equal measure some encouraging conclusions have emerged. In a report titled "Approaches to Safe nanotechnology" released March 2009, the US based National Institute for Occupational Safety and Health suggested:
"Nanomaterial-enabled products such as nanocomposites, surface-coated mate-rials, and materials comprised of nano-structures, such as integrated circuits, are unlikely to pose a risk of exposure during their handling and use as ma-terials of non-inhalable size."
Nanotechnology has a unique risk profile that may present challenges for claims that arise through various aspects of the nano-enabled product lifecycle. Claims could surface based on the following types of litigation:
* Product claims
* Environmental release claims (immediate & "Long-tail")
* Workplace exposure claims
* Fear claims
The 2007 Lloyds Emerging Risks report cited many areas of concern in the context of more ordinary nanomaterials in a balanced manner pointing to regulatory limitations on the one hand to suggesting:
"The assumption that nanomaterials behave like the equivalent conventional material could lead to a gross miscalculation of the risk."
Continental Western Insurance Group (CWIG), a U.S. regional commercial property and casualty insurer, recently announced that it would cease insuring against "bodily injury, property damage, or personal and advertising injury related to the actual, alleged, or threatened presence of or exposure to nanotubes or nanotechnology in any form" starting November 15. The insurance company claimed to base its decision on the unknown risks of nanotechnology generally and carbon nanotubes specifically, referencing recent reports of potential health risks associated with some multiwalled carbon nanotubes as a justification.
In response the U.S. NanoBusiness Alliance (NBA) suggested the insurer's decision (CWIG) to exclude nanotechnology as a singular entity was poorly thought out because nanotechnology itself did not have any inherent risks; only its applications and products could. The NanoBusiness Alliance also suggested definitions used by the insurer were so broad as to ensure almost any business would be subject to exclusion.
While the position adopted by Continental Western appears disheartening, the position stands at odds with the approach taken by another insurance company, Lexington Insurance Company. Lexington Insurance Company, a Chartis company, today introduced LexNanoShield, an integrated insurance product and array of risk management services designed for firms whose principal business is manufacturing nanoparticles or nanomaterials, or using them in their processes. LexNanoShield® can help insure, assess and manage these new nanotechnology exposures. For the exposures faced by these pioneering companies, LexNanoShield includes liability coverage that provides protection for general liability, product liability, product pollution legal liability and product recall liability exposures. In addition, first party product recall coverage is available to reimburse expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons. LexNanoShield also provides insurers with legal, technical and loss control consulting services to help develop, implement and assess nanotechnology-specific risk management programs.
Source: Nanotechnology Law Report, March, 2010
To view the press release issued by Lexington Insurance Company, March, 2010, a text can be accessed using the link below:
The contradiction in approach between these two insurance companies must be viewed in the context of the ongoing "Safety" debate in nanomaterials, particularly that underway of late in the United States and in Europe.
By 2011, the European Commission (EC) must respond to the April 2009 European Parliament (EP) resolution on the regulatory aspects of nanomaterials. The resolution calls for various "ambitious" measures to ensure safety with regard to nanomaterials and nanotechnology.
Recently the Belgian commissioner Magnette put forward five proposals from the Belgian Presidency of the European Union (EU) that is intended to respond to consumer needs while ensuring their safety:
* Define the obligation to inform the consumer of the presence of nanomaterials in consumer products;
* Ensure the traceability of the chain so as to be able to return to the source, if necessary. Regarding this aspect, it would be obligatory to maintain a register of nanomaterials;
* Identify the most appropriate regulatory path at the EU level for risk evaluation and management;
* Encourage member states, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favor of risk management, information, and monitoring; and
* Regulate the claims made on labels of products containing nanomaterials.
The Regulatory Framework
The regulatory framework for engineered nanomaterials within the European Union falls within the remit of REACH, while in the United States within the domain of the Environmental Protection Agency (EPA) and provisions enacted under 5c TSCA (Toxic Substances Control Act). NanoReg provides a summary insight into the regulatory situation in respect of the United States, which we reproduce here:
US Regulatory Summary
Environmental Protection Agency
TSCA - The Toxic Substances Control Act is the primary chemical control mechanism for new and existing chemical substances. Carbon nanotubes have been determined to be a new substance which requires the submission of a Premanufacture Notification to evaluate safety and register the substance. PMN submissions on CNTs generally require at a minimum a 90 inhalation study. The Agency has also been using Significant New Use Rules (SNURs) to require additional testing on existing substances (like metal oxides) that may now be produced in a nanoscale form.
Environmental Protection Agency
FIFRA - The Federal Insecticide, Fungicide and Rodenticide Act regulates agricultural pesticides and a wide variety of antimicrobials. A recent policy "reinterpretation" has led agency officials to determine that all antimicrobials containing nanomaterials are "new" and a full registration is required. This includes antimicrobials that had previously been registered which now must undergo a re-registration. This policy change is currently under review by the Office of Management and Budget officials as it will have a negative impact on antimicrobial registrations that were previously approved but now face additional scrutiny.
Many states have enacted their own chemical control regulations with at least seven states (out of 50) specifically calling out nanomaterials for treatment as "chemicals of concern". While this displays the breadth of nanotechnology regulation at the state level it pales in comparison to the potential impact of the State of California regulatory initiatives. Nanomaterials are the subject of regulatory activity at the Office of Environmental Health Hazard Assessment (OEHHA) and the Department of Toxic Substances Control (DTSC). Under the Green Chemistry initiative both agencies are in the process of developing nano-specific regulations.
At the DTSC the major issue revolves around a preliminary decision to consider materials under 1,000 nm to be nanoscale rather than the more commonly accepted 100 nm. OEHHA has taken a different approach by indicating that all nanomaterials will be considered a toxicity "trait." In essence all nanomaterials will be considered hazardous and subject to a broad range of regulations.
Food and Drug Administration:
The FDA has been relatively silent on nanomaterials despite a couple of public meetings in the last several years. They have always maintained that their existing testing requirements for drugs and medical devices were suitable for making the necessary safety determinations regardless of whether or not nanomaterials are involved. However, there is legislation in Congress to provide the Food and Drug Administration with $25 million dollars to investigate the toxicity of nanoscale materials in FDA-regulated products. It is anticipated that regulatory initiatives will eventually come into play even though the agency has maintained a very low profile on the subject.
Occupational Safety and Health Administration:
OSHA will eventually come into play as workplace standards for handling of nanomaterials further develops. The National Institute for Occupational Safety and Health (NIOSH) has conducted a series of field investigations of nanomaterial manufacturers and users. Although NIOSH is not part of OSHA, the data they collected was used to develop guidance which has been generally well-received by industry and will most certainly lay the groundwork for workplace standards at OSHA at some point down the road.
Source: John DiLoreto, NanoReg, Sept, 2010
9. INSCX exchange
Integrated Nano-Science &
"We cannot make a business case for composites in the auto industry."
Source: Alan Mulally, CEO, Ford Motor Company Inc, September 2010.
Citing the work left to be done on producing better steel and alloys for use in a practical commercial context, Mulally went on to suggest:
"getting enough composites to meet a volume maker's needs and the sheer cost of production nixes the prospect for now."
The statement above from one of the worlds leading automobile manufacturers was in reference to commercial limitations faced by business seeking to make a practical use of many advanced materials including engineered nanomaterials. The observation can in many instances be assumed to reflect a view that in many cases, a practical commercial use of these materials cannot be effectively priced into the supply-chain to deliver an end product for resale within margin limitations faced by the general as opposed to high end auto industry. While business noted the potential benefits to associate with these materials, and can be assumed to retain interest in exploiting their use, concerns as to their availability, lack of independent quality inspection, limited trade transparency and flexibility, and in many cases, doubts with regard to safety, appear to restrict the development of a wider commercial uptake.
The Commercial Case
A rudimentary 1st-order economic analysis points to a very clear set of policy shifts that can be easily implemented within the existing regulatory structures to improve efficiencies and reduce consumer, worker, and environmental risks today.
Bolstering the weakening U.S. insurance market for nanotechnology is a critical first step in ensuring the continued growth of the emerging market while providing a safe and responsible development of novel materials. The creation of a separate global risk market can provide an added incentive for continued innovation.
Both of these options provide significant benefits at essentially no costs.
Source: Extract cited from Facing New Challenges: EU-U.S. Nanotechnology Cooperation and Harmonization to Solve Global Energy and Environmental Problems by Nina Horne, Invited Expert to the OECD Working Party for Manufactured Nanomaterials (WPNM)
It is not suggested by this report as absolute that many advanced materials and nanomaterials in particular are unsafe or that producers are in some way irresponsible. The points are raised simply to highlight key commercial limitations preventing wider uptake. The same is true of many non-uniform raw materials such as in the case of the Polymer industry where the similarities can be suggested as relevant to the existing commercial evolution of nanomaterials. For the polymers industry the difficulty relates to another form of "insurance", what could be described as pricing insurance or Hedging.
The management of financial risk, in many ways, is not new to the plastics industry. Property insurance, for example, is a form of risk management as companies are covered from losses through plant fires and other liabilities through their insurance. Hedging is a different risk management tool but it also offers a similar level of certainty; enabling organisations to lock-in future prices and therefore more confidently focus investment on research, development and other capital expenditure. The intense price volatility that the (polymer) industry has suffered in recent years is starting to become unmanageable for many parts of the supply chain. Producers attempting to pass on rising prices are meeting resistance as the converters themselves are typically under pressure from consumers to maintain previously agreed prices. This means that converters are increasingly ‘squeezed' in the middle, and supply chains, rather than the suppliers, are competing.
Whilst the plastics industry supply chain grapples with these issues, the emergence of new world economies, such as China, and their demand for industrial raw materials is fundamentally changing the global balance of supply and demand. With these new market conditions, and with no indication of when they will end, the plastics industry desperately needs a long-term solution to the problem of price volatility.
It is not potential alone that ensures commercial uptake, rather it is the commercial usefulness of potential that enables participation or interest to grow. This can be assumed the import to conclude from assessment of the comments attributed to the US automobile supplier, Ford. Let us interpret in abstract the essential message along these lines as many companies responding in the context of advanced materials in this manner so to speak.
Can we use the potential, at the moment no? Are we interested in using these materials, Yes, but until we can actually make a commercial case we cannot do so.
The commercial case relates to supply assurance, safety, price and flexibility. While the insurance market has a vital role to play in terms of providing insurance against a safety risk, another mechanism has a role to play to enable the other form of pricing insurance, vital to drive increased commercial uptake. The combination of enabling both "insurances" stands to dramatically alter the commercial sustainability and growth prospects for engineered nanomaterials.
Changing the Game
The final section of our report provides an insight into a particular commercial development holding a potential to alter the position favourably for competing interest in engineered nanomaterials, providing a focal point for interaction between trade buyer and seller, insurer and regulator to capital investor and interest group.
David Hwang of Lux Research in a webinar dated July, 2010 provided and assessment of four specific markets that are leading the commercialisation of one key nanomaterial MWCNTs (Multi-Walled Carbon nanotubes) comparing 2009 usage figures against projected 2020 material usage estimates.
His conclusions are cited below;
* Sporting goods: 4 tons (2009) versus 270 tons (2020)
* Aerospace/defense: less than 1 ton (2009) versus 67 tons (2020)
* Wind turbines: 130 kg (2009) versus 253 tons (2020)
* Automobile industry: 56 tons (2009) versus 2351 tons (2020)
* Batteries: 67 tons (2009) versus 763 tons (2020)
The question must be asked; Are nanomaterials to be assumed commodities capable of being exchanged in observance of trade standards observed by other commodities such as metals, grains or products, or are nanomaterials wholly incapable of being traded in a standardised manner? While at base level such as in the case of some 20 leading nanomaterials, certainly they are commodities used to further a secondary process of manufacture toward end application of product. The following circular released by the exchange is referred to in abstract summary explaining the relevance of the project.
An observation cited by one of the authors to a report issued by the think-tank Demos titled "Governing at the Nanoscale: People, policies and emerging technologies" cast some insight in justification for application of a market process:
"It is the public working in many economic sectors that will be affected by nanotechnology, all the way from direct science-based industries to all the areas in which the products of nanotechnology might be put to use, who will, by embracing or failing to embrace nano-enabled products and in their working practices, determine their economic impact. In any case I'd prefer to put the issue in a positive way; in our system, societal needs and desires are delivered through market mechanisms, so achieving consensus on what society wants from nanotechnology will as a by-product lead to the desired economic gains."
INSCX exchange came about in recognition of a deficiency inherent in the overall nanotechnology commercial end-point; the lack of a defined market mechanism structure to coordinate the interaction of competing interests (Upstream Supplier, Downstream User, capital investor, insurer, regulator and consumer) in the allocation of resource pertaining to raw nanomaterials, the base used to deliver nano-enabled products and applications. INSCX™ exchange (Integrated Nano-Science & Commodity Exchange) is a commodity exchange established to trade to defined commercial standards of a wide range of nanomaterials, source materials and other commodities.
Launching in Europe and the United States by 2010, the exchange will permit physical trade in accredited, compliant and validated nanomaterials, ranging from basic raw materials such as carbons and metal oxides, advanced and source materials, nano-enabled and traditional commodities (grains, metals, minerals and products) to high-end, processed goods such as photonics and programmable matter. INSCX™ is based in the United Kingdom and will have satellite operations in the United States and Asia.
The aim of the exchange, which is endorsed by companies, organisations from government, academia, the world of commodity trading and various fields of nanotechnology, is to be the focal point of the emerging world trade in nanomaterials, a trade that will be crucial to continuing world prosperity in the 21st century. The opening of INSCX means that, for the first time, nanomaterials will be traded in the same way as basic commodities where purchasers will be assured of quality and competitive prices while suppliers will be provided with the financial tools and trade flexibilities needed to upscale to meet rising demand.
The rationale of INSCX is to empower nanomaterials on a par with existing established materials and commodities through provision of cost-effective tools to enable organic as opposed to leveraged growth. One key difficulty facing the nanomaterials industry has proven the distinct lack of access to impartial sources of capital to finance upscaling, concern as to transparency and regulation, the absence of uniformity in the specification of base reference materials in addition to there being limited efficiency at the point of trade in nanomaterials generally.
Other materials and commodity sectors we now regard as commonplace at some point in their commercial evolution all faced similar difficulties. For this reason the nanomaterials community should feel confident that solutions do exist which are practical and not self-serving.
Traditional materials (Grains, metals, Oils etc.) have for example overcome many difficulties now faced by the nanomaterials industry using the commodity exchange process to address capital limitations, provide a self-regulatory observance to more universal material and financial trade standards while securing efficiency at the point of trade to deliver physical product to standards accepted by the buy-side.
It is the very absence of these commercial essentials in the context of nanomaterials that appears to inhibit their growth potential.
INSCX simply follows the historical support legacy of commodity exchanges established in the 19th century for metals, grains and oils by providing the nanomaterials industry with the tools necessary to increase the commercial usefulness of this broad suite of innovative materials. The origins of commodity exchanges are commercial not financial, first formed by metals foundries and grain farmers several centuries ago needing more efficient trade process capable of meeting increased societal demand for foodstuffs and base metals. These commercial as opposed to financial origins guiding a commodity exchange remain with us today and underline the distinct difference between a commodity exchange and a financial market exchange.
INSCX will provide supplier access to trade finance, enable proprietary IP pertaining to any process of engineering a nanomaterial to be safeguarded while using the market process to develop commercial uptake, while also enabling accreditation to Nanomaterials (SHE) standard to be obtained by any supplier/downstream user of nanomaterials without accreditation posing a financial burden. Contracts will also incorporate standard ICC commercial terms and hopefully procedures to introduce a traceability mechanism supported by the levy of a Contingency "Shut-Down" premium on all exchange contracts can entice the insurance industry to consider extending coverage to account for a situation where nanomaterials can be indemnified on the basis that not all, if any will face the prospect of being banned.
These are all compliments toward the common objective, that being to enable both commerce and society to benefit from the emergence and sustainability of compliant nanomaterials, proving to potential users the observance of benchmark standards in supply/use quality, material quality and trade integrity.
Assurances to Buyers
From a buyer's perspective, buyers of nanomaterials will be assured as to material quality, price transparency and flexibility and guaranteed supply for any material traded via the INSCX exchange process. Industrial buyers of any raw material operate a tunnel vision mentality. They do not for example opt to ditch use of reliable raw materials in favour of mere potential. INSCX exchange is about transforming commercial potential to commercial fact satisfying the needs of industrial buyers. The standards introduced by INSCX are basic commercial standards demanded by the industrial scale buyer of any classification of raw materials. More buying of nanomaterials translates to sales revenue for nanomaterials suppliers. It is a simple but practical logic and our minds need to be collectively focused on that end. Without sales, revenue and a means to reinvest profit accrued for growth the entire SME nanomaterials sector faces commercial extinction and most certainly will surrender its autonomy. This we cannot permit to be the outcome of the wealth of innovative talent. Those nanomaterials suppliers who now rally around the INSCX exchange project will find in us a strategic partner interested in their growth as ours will depend on theirs and visa-versa.
Nanomaterials are relatively a new feature in a commercial context and much debate has centred on the issue of regulation. While various official organisations grapple with the issue of regulation, pertaining to reference materials, toxicology, registration and societal issues, nanobusiness seems content to play a "waiting-game" in essence hoping official "top-down" regulators get it right.
INSCX exchange is about developing a self-regulatory structure in the trade of nanomaterials continuing the route taken by now established traditional commodity markets, where participants (trade buyers and sellers) of various commodities came together to agree trade standards to be observed.
Self-regulation by definition has proven more effective that official "top-down" regulation as it enlists the willing consent of parties to commercial interest in a given material or commodity.
What is often "agreed in the trade" has traditionally formed the basis for a working official regulatory framework. By and large in the context of global trade, self-regulation has usually pre-empted and helps define a basis for working legislative regulation. With nanomaterials this tradition seems to be reversed with an over-reliance on official "top-down" efforts to enact regulation where there exists a skills-gap outside of organisations such as the OECD, European Union, US and other Nanoscale networks within many regulatory agencies.
Commercial Health & Safety
Health & Safety with nanomaterials has inherited many of the business culture aspects evident in the context of H&S provisions in the traditional world of late leading to a situation where almost every measure or certification programme is provided on a profit-basis beyond the financial resource ability of the target audience; namely SME nanomaterials suppliers.
Downstream users of nanomaterials, often large conglomerates are in a position to fund expensive Health & Safety programmes, but with notable exception are not established manufacturers or engineers of nanomaterials, but users. While both upstream (SME nanomaterials manufacturers, toll processors, compounders etc) and Downstream users require audit inspection to an industry standard, SME nanomaterials suppliers cannot afford to bear the cost. Schemes that are introduced beyond their financial resource, however well intentioned are practically pointless.
INSCX exchange fully appreciates the SME status of nanomaterial suppliers and other Upstream inputs, and has devised a means where the cost of enrolling participants to accept as mandatory a graduation to involve undergoing (SHE) inspection audit does not pose a burden simply as a result of lack of financial resource. The system is referred to as the (SHE) Credits System.
(SHE) Credits System
INSCX exchange have negotiated a means whereby SME nanomaterials suppliers and users can qualify to use the trade process to fund achievement of nanomaterials (SHE) accreditation status provided by AssuredNano™. The scheme is endorsed by the world renowned Institute of Occupational Medicine and adopted as a benchmark ENS standard by INSCX exchange.
Full details of the Nanomaterials (SHE) Scheme can be obtained accessing the link:
Using a process of applying a small transaction levy on the occasion of trade suppliers and users of nanomaterials can accumulate funds to cover the cost of (SHE) accreditation effectively removing financial cost as an obstacle to increasing industry adherence to a benchmark standard. In addition to the (SHE) credits system, which in itself is a practical solution to SME nanobusiness acquiring a base EHS standard, INSCX will introduce a number of other measures designed to overcome "roadblocks" and other obvious obstacles to pursuit of compliant commercialisation. These are outlined subsequent.
In a response to repeated calls for the labeling of consumer products containing nanomaterials, which many observers in the commercial world regard as placing nano-enabled products at a perceived disadvantage to rival products, an effective "Brand-nano" as it were, INSCX will introduce a variety of measures to address the matter in addition to addressing the traceability issue.
As opposed to branding the sequencing of the initial trade ID number procuring raw nanomaterials via the exchange will introduce as mandatory on all users of the exchange the instruction to carry forward the Trade ID number through all the stages of the supply-chain. In the case of any device or a transistor for example, the end-product containing the item can simply incorporate this number perhaps on an end-product bar code or embed using RFID technology. The use of a number as opposed to "Brand-nano" option could find more acceptances with industry participants who fear labeling may perhaps somehow portray all "nano" as somehow "bad" or suspect.
A key concern expressed by authorities relates to a manner to effectively trace nanomaterials throughout the supply chain, a concern also held by commercial interests such as the insurance industry. While official regulation agencies continue to work toward introducing formal procedures to affect a traceability INSCX exchange have introduced the following Downstream Audit Sequencing and Shut-Down Contingency measure as standard. Use of the initial trade ID number generated at the point of raw nanomaterial supply via a trade executed on INSCX can be used as a reference for Downstream Audit Sequencing through the supply-chain process. An exchange rule will compel any supplier and/or downstream user procuring the raw material to carry forward or sequence this reference number providing a basis for reverse audit.
It is accepted occasion may in future arise where a societal concern compels regulators to order a ban or restriction on trade in a given nanomaterial. Given that any move to ban or restrict a material poses a financial risk to commercial parties engaged in its supply or use, and the very global nature of nanomaterials, INSCX propose the incorporation of a Shut-Down premium into all exchange contracts as a means to encourage global insurers to contemplate extending coverage to nanomaterials against such a contingency. Quite clearly without some safety-net incentive in place commercial interest faced with a move to ban in societal interest will be tempted to act to delay implementation of any ban or trade restriction. Equally, the implementation of such a measure by official regulators would face difficulty arising from the global nature of the industry.
The "Shut-Down" approach offers two possibilities or options to both industry and international regulation agencies strengthened by the global reach of INSCX which will provide a live market access across Asian, European and North American time zones.
Use of "Shut-Down" premium levied on all trade through the exchange as a basis to build a contingency reserve to be dispersed at the discretion of official regulation agencies to help deal with a societal risk and/or to compensate commercial interest. The option of using the "Shut-Down" premium could also be used as a means to encourage insurance underwriters to write a contingency risk clause for nanomaterials. Added to the application of the Downstream Audit Sequencing compulsory on all members and customers of the exchange, the collective offering provides a basis to achieve several common objectives:
a) The extension of a safety-net to commercial interest in nanomaterials and the deployment of structured exchange practices to suspend trade in a specific nanomaterial.
b) The providing of financial incentive based on the law of probability as not all nanomaterials will face a ban or restriction to the insurance industry to act as a driver toward compliant commercialisation extending contingency coverage to include interest in nanomaterials.
c) The providing to official regulators of a reference basis on which to target an effective recall from end-product/device to source material on a global basis. Should societal risk be proven exchange records of all trade in the relevant nanomaterial will be made available for inspection.
This self-regulatory approach offers a basis to balance commercial and societal interest equally and can be used to make official "top-down" regulations more universally welcomed, effective and practical driving in essence a regulation by consent.
1. Trade Standards - INSCX offers the ability to provide potential buyers of nanomaterials the very same standards they demand of existing materials, namely price transparency, quality/supply assurance, commercial insurance and trade flexibility, the latter the ability to procure materials on a cash and forward basis. These benefits alone will prove central to increasing the commercial/industrial uptake of nanomaterials benefiting suppliers providing organic revenue growth supported using the exchange process to acquire trade finance to sustain upscaling in supply capacity.
2. Health & Safety Standards - INSCX exchange offers nanomaterials suppliers and downstream users of nanomaterials the ability to use the exchange process to become Nanomaterials (SHE) accredited without accreditation to this benchmark standard endorsed by the Institute of Occupational Medicine being a cost burden. Through definitive contractual agreements with the scheme's global provider, AssuredNano™ www.assurednano.eu, participation with INSCX exchange enables any supplier and downstream user to graduate toward full (SHE) accreditation without having to commit initial capital.
3. Regulation - INSCX exchange is a process to engender self-regulation within nanomaterials devised by commercial interests in the field enabling the wider industry to provide official regulatory bodies with a working template on which to base formal, legislative regulation. Participation means in effect the embodiment of a single but yet material specific industry voice to official bodies via an exchange mechanic. The rationale of INSCX is not concerned with profiting at the expense of members in helping coordinate material specific trade associations.
Rather, the exchange will profit from increased trade activity in raw nanomaterials where the primary benefactor will be nanomaterials companies themselves. Rather INSCX is determined to provide practical, no-nonsense solutions. Nanoindustry needs to be able to deal with official regulators from a collective position of strength, INSCX provides the mechanic to do so with clarity above and beyond a need for a tax along the way.
4. INSCX will provide a true assessment of the economic value of nanomaterials enabling the global investment community to value nanomaterials on a specific case by case basis using factual evidence of trade flows.
10. Geographical Considerations
While efforts continue to raise public awareness in nanotechnology, albeit through burdening the scientific community with an obligation to explain to the public the relevance of the field, nanobusiness continues to develop although predominately centered in the SME bracket.
Nanotechnology is global in distribution with substantial presence in the United States, Europe, Japan, China, Brazil, Canada, Australia, Iran, Russia, Poland and many other nations the world over.
The ‘2008 Nano-scale Materials and Markets' report by Nano-posts is one of many examples analyzing nano-scale technology companies across the globe, by region (Europe, Asia- Pacific, and the US). This report cites Europe as leading the way in terms of such companies, with numbers in 2007 estimated at 1100. US companies are estimated at 900 and the Asia-Pacific region at 700, with China and Japan in first and second positions with 154 and 136 companies respectively.
The current approach and Round Robin testing methodology in place is not a certain guarantee that nanomaterials diffused downstream will not be harmful when mixed or used with other downstream materials. Accreditation on the other hand is also no guarantee or pertains to be a downstream guarantee on which to calculate risks. What the (SHE) accreditation scheme can guarantee is that a thorough safety evaluation has been implemented in the factories and up stream labs. (SHE) Accreditation can also ascertain units of risk through indicators based on universal production and fabrication struts.
Nanomaterials (SHE) will be made compulsory on all exchange participants regardless of domicile, and procedures are in place to evaluate more localized accreditation schemes in accordance with standards implemented by (SHE). Whilst we can offer no guarantee on safety, a check and balance approach stipulated by insurers themselves will compliment exiting efforts, and assist insurers with calculable risk units which compliment global insurance schemes.
Less Developed Regions
In relation to less developed countries the safe handling and management of nanomaterials structures and devices is far from certain. Some countries have no effective reporting schemes or accreditation. They either do not exist or are fragmented. Add in the difficult posed by cost. How much will it cost to ensure nanomaterials suppliers can become (SHE) accredited? Both the less developed country and cost difficulty are overcome somewhat using the INSCX exchange process.
One key area of risk for regulation agencies and insurers relates to the global nature of nanotechnology and the tendency for regulatory disparity and emphasis between different nations and regions. Often political and economic influences peculiar to individual socio-economic needs encourage nations and economic interests on occasion to thwart or restrict the implementation of regulations perceived as affecting local conditions in an adverse manner.
Often we hear in the traditional world of nations introducing tariffs or anti-competitive practices in the trade of essential raw materials - some examples of late:
* Russia - Gas exports, wheat
* China - Rare earths
* India - Steel
Perhaps the most profound example was the situation where OPEC in the 1970s caused near panic in world energy markets with the introduction of a ban on oil exports.
Two issues face regulators and the world of business. How to overcome situations where local interests take precedence over global interests and how regulation can be implemented on a uniform basis.
A global market process can help solve some of the difficulties - the response to OPEC was the introduction of financial futures in oil markets to encourage price insurance liquidity by way of capital commitment by non-commercial users (investment banks, traders etc.) While oil always had a forward market, as grains did, the market was a physical in the trade market and more liquidity was needed to overcome supply bottlenecks in times of crisis.
In the context of nanomaterials, they are a long way away from being classed investment grade, rather they must start the commercial valuation and transparency process in much the same manner as grains did some 150 years ago. INSCX can help achieve this aim. The second feature is how to ensure regulation is uniformly adhered to. The ability to ensure official regulation is strengthened by a global commercial self-regulatory structure, which is what a commodity exchange is, can be of assistance to overcome regional and local disparities.
The two insurances - actual insurance to cover societal risk and the Pricing insurance capability of the market process are inextricably linked and can act to support effective official "top-down" regulations in these and a number of ways.
On reflection insurers will need to be proactive in calculating the lack of risk structures not only in the context of the commercial deficiency inherent in nanotechnology, but also in relation to less developed regions where local deficiencies in implementation may exist. The nanomaterials industry has nothing to fear from the introduction of the two insurances, for these are central to ensuring growth in a commercial context as has been proven time and time again throughout economic history. The key point to accept is these insurances effectively strengthen the hand of official regulators acting to safeguard societal interests, and no industry can really object to self-regulation. To do so would be commercial suicide and it would equate to being an affront to any potential buy interest in the sector objecting.
The suggestion is therefore, based on delivering the two insurances (actual and price) into the nanotechnology commercial framework. Accordingly, INSCX extends an invited to insurers to work in tandem with exchange efforts to drive a self-regulatory process in nanotechnology extending to involve participation from less developed countries in the formalised process of trade envisaged.
There appear clear gains to be made through exploring the merits of joint initiatives between the INSCX commodity market accreditation/trade methodology and insurers going forward. The very global reach of a commodity exchange as we have suggested can act to overcome regional difficulties in interpretation of "official" regulations should incident arise as exchange rules and regulations would be mandatory on all participants regardless of domicile.
It is hoped some of these suggestions can be taken on board going forward.
About INSCX exchange
Integrated Nano-Science & Commodity Exchange (INSCX exchange) is a formal commodity exchange trading platform devoted to the structured physical trade of a wide range of Thematic Class Materials (TCMs) including nanomaterials, advanced materials, nano-enabled commodities/composites and more traditional commodities such as metals, grains, products and oils. All physical-delivery material contracts listed on the exchange are sourced (SHE) accredited, compliant and supplied validated and insured. Commodities listed for trade by us range from basic raw nanomaterials (NMs) such as carbons, metal oxides, specialty chemical solids, traditional commodities and high-end, processed goods such as photonics and programmable matter. The exchange is based in the UK operating live trading access within Europe and North America with full global rollout to be made available by 2011. INSCX aims to be the global focal point of emerging trade in nanomaterials, a trade which will be crucial to continuing world prosperity in the 21st century. The deliverable of INSCX is an electronic/voice-brokered commodity trading platform enabling price discovery, trade integrity and conformity to agreed material standards, while providing supports for suppliers and purchasers to enhance the commercial usefulness of nanomaterials. Building on centuries of exchange heritage, INSCX serves the risk management and commercial trading needs of global customers particular to the manufacture, use, application and exchange of engineered nanomaterials, advanced materials and nano-enabled commodities. We are the worlds only source of benchmark cash and forward contracts in alternative commodities covering all eleven Thematic Classes available on any exchange.
Our vision provides the market infrastructure to enable these commodities realise their potential as the alternative, precision engineered materials of the future.
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An engineered surface unsticks sticky water droplets August 31st, 2015
Sonocatalysts Able to Purify Organic Pollutants of Wastewater August 19th, 2015
Flexible dielectric polymer can stand the heat August 6th, 2015
Sol-gel capacitor dielectric offers record-high energy storage July 30th, 2015
New composite material as CO2 sensor June 8th, 2015
An engineered surface unsticks sticky water droplets August 31st, 2015
National Space Society Welcomes Geoff Notkin As New NSS Governor August 26th, 2015
A thin ribbon of flexible electronics can monitor health, infrastructure August 17th, 2015
Developing Component Scale Composites Using Nanocarbons August 26th, 2015
'Diamonds from the sky' approach turns CO2 into valuable products August 19th, 2015
Engineering a better 'Do: Purdue researchers are learning how August 4th, 2015
Proving nanoparticles in sunscreen products August 4th, 2015
Proving nanoparticles in sunscreen products August 4th, 2015
Battery Technology/Capacitors/Generators/Piezoelectrics/Thermoelectrics/Energy storage
Artificial leaf harnesses sunlight for efficient fuel production August 30th, 2015
'Diamonds from the sky' approach turns CO2 into valuable products August 19th, 2015
Small but heading for the big time: Nanobiotix half year results for the six months ended 30 June 2015, in line with expectations: Major clinical achievements and corporate developments August 28th, 2015
Artificial leaf harnesses sunlight for efficient fuel production August 30th, 2015
Novel nanostructures for efficient long-range energy transport August 21st, 2015
Charge transport in hybrid silicon solar cells August 17th, 2015
Smarter window materials can control light and energy July 22nd, 2015
Research findings point way to designing crack-resistant metals June 24th, 2015
Solar cells in the roof and nanotechnology in the walls June 16th, 2015