Pieter van Broekhuizen, University of Amsterdam, Holland

advertisement
Intergovernmental Forum on Chemical Safety
Global Partnerships for Chemical Safety
Contributing to the 2020 Goal
ABSTRACTS
Nanotechnology and nanomaterials:
opportunities and challenges
ROOM DOCUMENT
List of Contents

General Introduction:
Nanotechnology and nanomaterials: opportunities and challenges
Georg Karlarganis, Federal Office for the Environment (FOEN), Switzerland

Nanotechnology: what is it?
Germ Visser, DSM Innovation Center, The Netherlands

Health effects of free engineered nanoparticles – an evolutionary perspective
C. Vyvyan Howard, University of Ulster, United Kingdom

The interaction of manufacture nanomaterials with our organism – example lung
Peter Gehr, University of Bern, Switzerland

Occupational Health and Safety: possible challenges and risks for workers
Pieter van Broekhuizen, University of Amsterdam, Holland

Little BANG theory (Bits, Atoms, Neurons and Genes): The socioeconomic
impact of technological convergence at the nanoscale
Pat Mooney, ETC Group, Canada

Nanotechnologies – new technological hype with uncertain consequences for
society? How choices of technologies impact on the development of society
Claudia Neubauer, Citizen Sciences Foundation, France

Nano-Divide: a question of justice?
Andreas Bachmann, ethic im diskurs, Switzerland

Nanotechnologies at the OECD
Rob Visser, OECD, Paris, France

International standardization – supporting safe and successful
nanotechnologies for all stakeholders
Peter Hatto, Chairman ISO/TC 229 – Nanotechnologies, IONBond Ltd., United
Kingdom

Intergovernmental dialogue on nanotechnologies: The case of the OECD
Working Group on Nanotechnology
Francoise Roure, Vice-President of the OECD Working Group
on Nanotechnology

Nanotechnology and manufactured nanomaterials – ongoing and planned work
in the UK
Jane Stratford, Department for Environment Food & Rural Affairs, UK

NanoSafety in Thailand
Lerson Tanasugarn, Chulalongkorn University, Thailand

Status of Nanotechnology in Nigeria: Prospects, Options and Challenges
Olusegun O. Adewoye, NASENI, Nigeria

History and current status of Nanotechnology in Russia. Contribution to global
dialog on EHS issues
Marine Melkonyan, , A.V. Shubnikov Institute of Crystallography of RAS,
2
Moscow, Russia

Current Status and Perspectives of the Nanotoxicity Research in Korea
Kyung-Hee Choi, Ministry of Environment, Republic of Korea

The small and the risk – a view from the re/insurance industry
Thomas Epprecht, Swiss Reinsurance Company.

Role of National Nanotechnology Center (NAOTEC) and the Code of Conduct
for Responsible Nanotechnology in Thailand
Noppawan Tanpipat, National Nanotechnology Center, Thailand

Nanotechnology in a Developing Country – applications and challenges
Babajide I. Alo, University of Lagos, Nigeria
3
Nanotechnology and nanomaterials: opportunities and challenges
General Introduction
Dr Georg Karlaganis, Head of the Substances, Soil, Biotechnology Division
Federal Office for the Environment (FOEN) Switzerland
Nanotechnology is a rapidly emerging technological approach that is expected to result
in major changes across many industry sectors. This may bring many advances to
society and benefits for the environment, but also poses new challenges, especially in
health and safety. To date discussions on the potential benefits of nanotechnology
have, for the most part, taken place separately from those on the potential risks to
human health and the environment of nanomaterials. Such discussions should take
place concurrently. As a result of nanotechnology’s rapidly burgeoning growth, it is
important that all stakeholders concerned (governments, international, regional and
national organizations, industry groups, public interest associations, labour
organizations, scientific associations and civil society) engage in discussions to identify
and address issues that may impact health and safety in positive or negative ways.
The objective of the plenary session will be to exchange information in order to help
raise the awareness of participants to the potential new opportunities, the new
challenges and the new hazards and risks posed by nanotechnology. The meeting will
provide a forum to share information on known and emerging issues, on the work of the
OECD and ISO on nanotechnology and to foster an understanding of issues
(applications and implications). The Forum will also be an opportunity to discuss the
potential contributions of nanotechnology to sustainable development and to discuss
how to achieve an equitable distribution of benefits and risks and role of responsible
stewardship in addressing nanotechnology.
Governments around the world are looking at the new opportunities offered by
nanotechnology and are keen to understand, avoid, reduce and manage risks
associated with this new technology and nanomaterials. To facilitate this process a
draft Dakar Declaration on nanotechnology and manufactured nanomaterials is
presented by the lead sponsor to the Forum for its consideration.
***
Documents for the session are:
-
Thought Starter, Nanotechnology and manufactured Nanomaterials:
Opportunities and Challenges, Prepared by: FSC Working Group, lead sponsor
Switzerland
(IFCS/FORUM-VI/01.TS)
-
Nanotechnologies at the OECD, Prepared by: OECD
(IFCS/FORUM-VI/4 INF)
-
Activities on Nanotechnologies in the IOMC Organizations, Prepared by: OECD
Secretariat at the request of the IOMC
(IFCS/FORUM-VI/5 INF)
-
an overview of the work of ISO on nanotechnology and manufactured
nanomaterials
(IFCS/FORUM-VI/6 INF)
4
Nanotechnology: what is it?
Germ W. Visser, DSM Innovation Center - CTO,
The Netherlands.
Nanotechnology will be explained from the perspective of a multi-specialty chemical
company. Royal DSM N.V. creates innovative products and services in Life Sciences
and Materials Sciences that contribute to the quality of life. DSM’s products and
services are used globally in a wide range of markets and applications, supporting a
healthier, more sustainable and more enjoyable way of life. End markets include
human and animal nutrition and health, personal care, pharmaceuticals, automotive,
coatings and paint, electrics and electronics, life protection and housing. DSM has
annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide.
The company is headquartered in the Netherlands, with locations on five continents.
With the general theme of its strategy “Vision 2010: Building on Strengths” DSM
expresses the intention to maximally exploit the potential opened up by the successful
transformation of the company during the preceding strategic period. Innovation is one of
the main accelerators for the growth of the company in targeted areas.
Mega societal and technological trends in the world are the key drivers for the
development of new products and concepts at DSM. For future applications in different
sectors advanced materials are a decisive factor. A technological drive of crucial
importance for the development of smart materials is the convergence of biotechnology
and nanotechnology. Examples of such developments at DSM and elsewhere will be
presented next to every day and historical nanomaterials. Their social and
environmental utility will be discussed.
All new technologies including nanotechnologies do include potential risks that need to
be managed. Nanotechnologies are a collection of various very diverse technologies and
their risk cannot be approached as such. A more specific risk assessment in function of
the applications is needed. Risk is a function of hazard and exposure and some
categories of individuals are more at risk for effects of nanomaterials than others.
Proper risk assessment is hampered by a lack of data. The lack of standards for
characterization, evaluation of toxicology and occupational health (both assessment and
protection) makes it difficult to develop knowledge about toxicological aspects of
nanomaterials. At present many different organizations are trying to close the gaps. A
global concerted and well orchestrated action is needed to answer the many questions
that are emerging.
Besides the technical approach there is also the perception of people. This factor
needs to be addressed in the proper way as it will be public acceptance that will make
or break the applications of nanotechnologies.
5
Health effects of free engineered nanoparticles – an evolutionary perspective
Prof. C. Vyvyan Howard
University of Ulster, UK
We have always been exposed to nano-particles, mainly consisting marine aerosol,
minute crystals of soluble salts windblown from waves in the sea. However, there were
relatively few other inorganic nano-particles of less than 100 nm in the air throughout
our prehistory. The main biological nanoparticles were viruses and some other
biological particles. That changed when man harnessed fire about 100,000 years ago
and combustion nanoparticles became a common part of man’s environment. Our
defence mechanisms against nanoparticles evolved principally to cope with the
biological threat posed by viruses
There is evidence that nano-particles can gain entry to the body by a number of routes,
including inhalation, ingestion and across the skin, and can then travel around the body
into various organs, including across the blood-brain barrier (Gumbleton, 2001). These
properties are being positively harnessed by the pharmaceutical industry to improve the
efficiency of drug delivery, and there is now growing recognition that the same
properties could apply to ‘uninvited’ nano-particles resulting from pollution or
manufactured products.
It has been shown that insoluble nano-particles can be toxic and therefore potentially
hazardous (Oberdorster, 2000). Nano-particles have a potential for toxicity that appears
to be related primarily to their small size rather than to the type of material from which
they are made, although there is still much research to be done before this question is
fully understood. The upper size limit at which the toxicity associated with nanoparticles ceases is not fully known but is thought to lie between 65 and 200 nm. One
area of concern that is, as yet, under researched is the ability of nanoparticles to cause
protein misfolding (e.g. Bilsten et al, 1997 )
There is epidemiological evidence showing that exposure to particulate aerosols leads
to long term health effects, primarily of the cardio-pulmonary system (e.g. Wichmann
and Peters, 2000). There is also evidence that short term effects from poor air quality is
due to particle overloading.
Enough evidence is already extant to demonstrate that nano-particles are likely to pose
a health hazard and that human exposure in general, and in particular in the workplace,
should be minimised on a precautionary basis. A number of expert working groups
have met under the auspices of the EU and it appears that there will be new legislation
considered in the near future
(http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm). The insurance industry
is also taking a keen interest. While it is easy to appreciate how nanotechnology is
being harnessed to positive uses in the pharmaceutical, electronic, food and water
industries uses, there is an urgent need to control and minimise the generation of
unnecessary nano-particles, particularly of the insoluble variety, in the ambient
environment. For example there are early indications that some types of carbon
nanotube can mimic asbestos and induce mesothelial tumours (Takagi et al, 2008).
The last thing that society should wish to do is to leave a long term negative legacy for
future generations As far as can be determined, the risk assessments to address the
misgivings outlined above are not yet in place. It seems important that the long term
environmental fate of such products be determined before mass production proceeds.
We must act on a precautionary basis.
Bilsten et al (1997). FEBS Lett 402: 67-72.
6
Gumbleton M (2001) Advanced Drug Delivery Reviews 49: 281–300
Oberdorster G. (2000). Phil. Trans. R. Soc. Lond. 358: 2719-2740.
Takagi A, Hirose A, Nishimura T, et al. (2008). J. Toxicol. Sci. 33: 105-116.
Wichmann, H.E., and Peters, A. (2000). Phil. Trans. Roy. Soc. Lond. 358: 2751-2769.
7
The interaction of manufactured nanomaterials with our organism – example
lung
Peter Gehr, Ph.D., Professor and Chair, Institute of Anatomy, University of Bern, Bern,
Switzerland
Progressively more nanoparticles, defined as manufactured structures of ≤100 nanometers size, are released into air, water and soil every year from different sources,
including nanotechnology. The human health benefits of nanotechnology are
undoubted, however, occupational exposure, direct human exposure through medical
applications and ambient air pollution may, depending on the dose and particle
characteristics, cause adverse health effects. The environment is affected similarly.
Most toxicity research so far has been carried out with mammals, mainly focusing on
the respiratory system, but also with other animals, like e.g. fish and daphnia as well as
with plants and, last but not least and most importantly, also with cell culture models.
Let us focus on human exposure by inhalation, in order to explain the mechanisms of
adverse effects nanoparticles may have. A huge internal pulmonary surface area of
150 m2 in humans with a minimal air-blood tissue barrier of <1 µm is available for the
interaction with inhaled particles. It has been found that nanoparticles, not larger
particles, can cross the air-blood tissue barrier and enter the blood capillaries.
Scientists have shown that exposure to combustion-derived ultra fine particles can be
associated with pulmonary and cardiovascular diseases. The mechanisms are believed
to include oxidative stress and inflammatory reactions in cells.
We have found with inhalation experiments in whole animals and with in vitro studies in
cell cultures using different types of manufactured nanoparticles a transport mechanism
that includes a non-specific penetration of particles into cells by adhesive interactions.
We were able to show that nanoparticles may cross the air-blood tissue barrier in a
directed way entering the capillary blood. From there the nanoparticles can be translocated to other organs.
The adverse potential of nanoparticles is greatly enhanced by their free location and
movement within cells. Nanoparticles may be found in mitochondria and the nucleus
suggesting toxic and carcinogenic potential.
Thus, nanotechnology and its use in many applications have the potential to induce a
spectrum of human health and environmental hazards. Because we still know little
about the mechanisms of the development of such hazards, toxicological studies and
regulations are essential before the large scale industrial production of nanoparticles
occurs.
8
Occupational Health and Safety: possible challenges and risks for workers
Pieter van Broekhuizen, University of Amsterdam, Holland
Hundreds of consumer and manufactured products containing engineered
nanomaterials or made with the use of nanomaterials are already on the market. Quite
a lot of these products, as well as their base materials are been made today and placed
on the market without thoroughly knowing whether nanomaterials are released from
them and what their potential impacts on human health and the environment may be.
Workers all along the production chain from laboratories through to manufacturing,
transport, shop shelves, cleaning, maintenance and waste management may be
exposed to these new materials. Nevertheless it is unknown whether the safety
procedures implemented are adequate or the protection measures applied are
sufficient. In many cases they are even uninformed about the potential risks, simply
because the risks are still unknown. As a consequence nanoparticles are discharged
and disseminated out into the open without knowing what the consequences may be
and up till now without effective ways of detecting and measuring them.
Workers engaged in research, development, manufacture, packaging, handling,
transport, use and elimination of nanomaterials and nanotechnology products will be
most exposed, and therefore most at risk of any harmful effects. Therefore a
precautionary approach to secure the health and safety at work must have priority in
any nanomaterials surveillance system. There is a great need for training, education
and research in order to allow health and safety specialists (e.g. labour inspectors,
preventive services, occupational hygienists, company physicians) preventing known
and potential exposures to nanomaterials that have not been proven safe.
In spite of the fact that there are still many gaps in knowledge required to make a
responsible risk assessment and design a safe workplace, there are already many
tools that may be applied to go for a worst case, precautionary approach. These tools
can be found in “traditional” risk assessment and the development of occupational
exposure limits by adapting these systems to the nanoscale.
Furthermore it is identified that requirements formulated under the new REACH
regulations can be applied to the materials on the nanoscale, and that an adaptation of
some premises in REACH, especially concerning the data requirement and obligation
to make chemical safety reports for intended use of chemicals, may provide excellent
opportunities for a responsible precautionary nanoapproach.
9
Little BANG theory (Bits, Atoms, Neurons and Genes): The socioeconomic impact of
technological convergence at the nanoscale
Pat Mooney, Executive Director, ETC Group (Canada)
From Brussels to Beijing, science policy makers are talking about technological
convergence (the coming together of biology, chemistry, and physics) at the nanoscale.
While this technological convergence offers enormous opportunities for the improvement of
environmental quality, energy efficiency, water and other natural resource maximization,
etc., it also poses substantial threats to commodity export-dependent developing countries.
At this early stage in the development of nanoscale technologies it is difficult to know either
the quantities or the types of raw materials that may be required. It's equally difficult to
predict potential changes in economic structures and regulatory arrangements. Since most
of the intergovernmental dialogue related to nanotechnology and technological
convergence tend toward the optimistic (if not euphoric) end of the opportunities/risk
spectrum, I will focus on risk elements that I believe have not been given adequate
consideration.
There are lessons from the history of technology introduction that may be useful in guiding
country-level planning. First, we must recognize that new technological waves are not a
"force of nature" but manufactured processes. Economic interests suppress some
technological opportunities in order to advance others depending upon their perceived
needs at the time. It is as important to consider what is suppressed as it is to consider what
is promulgated. Secondly, it seems to take a human generation to fully comprehend the
wider environmental and socioeconomic implications of a new technology. Early
projections (for good or ill) are almost always wrong. Thirdly, (and this is becoming
increasingly the case) venture capital exigencies tend to push new technologies into the
marketplace before they are perfected -- leading to problematic health, environmental, and
social conditions. Fourth, once introduced, new technologies are extremely difficult to recall
if they are found to be dangerous. With rare exceptions, technologies or specific products
are only withdrawn after the introducing industries have exploited the lifecycle of their
production system and have found a commercially-profitable alternative. Fifthly, because
technological waves are manufactured, marginalized countries and people rarely see the
wave coming and are swamped in its trough for at least a generation. Although new
technologies portend break-throughs and talk of leapfrogging over old technologies onto
new scientific platforms, the socioeconomic environment within which the new technology
is introduced is likely to determine who benefits. In general, major technologies introduced
into an inequitable society will (initially) exacerbate the gap between the rich and the
marginalized. It is not simply that the rich get richer for the first few decades or generations
but the poor get poorer. Finally, new technologies do not need to be scientifically
successful in order to be commercially profitable. Governments and society need only be
persuaded of the inevitability and potentiality of the new technology in order for it to
displace other technologies and for its owners to make demands of the socioeconomic
system.
Although there is much talk about technological convergence there is less recognition that
technological convergence invites corporate concentration and may require protective
regulations and greater convergence between public and private sector science. While we
struggle to understand the impact of new technologies on commodities and markets, we
must also consider the potential for this convergence to evolve patent regimes that allow
for multi-sector industrial monopolies and a new round of mergers and acquisitions -- or
alliances -- that could give unprecedented control to new economic actors. There is an
urgent need to monitor intellectual property and other competition policy regulations.
There's also an urgent need to begin the long process of creating an International
Convention for the Evaluation of New Technologies (ICENT).
10
Nanotechnolgies – new technological hype with uncertain consequences for
society?
How choices of technologies impact on the development of society.
Dr. Claudia Neubauer, Citizen Sciences Foundation, France
In the last two centuries, synthetic chemicals have been deeply transforming the world.
Nowadays, products at nano scale present radically new properties leading to
numerous new applications but also to new and probably unexpected risks and
consequences - for human health, for the environment and for our societies at large.
Nanosciences and nanotechnologies (NST) present a sector of intense international
competition and pretend to impose a scientific and technological (r)evolution impacting
on every domain of social life. But like all scientific knowledge and modern technologies,
they are situated in concret social, political and historical contexts, involve many
substantive social, political, economic and cultural transformations and affect social and
political structures throughout a society. Technoscientific knowledge is not neutral nor
are the conditions of its production or the visions of a future society it is transmitting.
However, technology policies often escape public scrutiny. Nowadays, the principal
scientific and technological choices are influenced by market, researchers and
bureaucrats, and decisions are often made outside the operational framework of our
democracies. NST are part of a dominant political discours that proposes technical
fixes for social problems, reduces public research to a subcontractor of economic
competitiveness and growth, strengthens private intellectual property rights and
promotes high-tech solutions as sources of employment, security and happiness.
Nevertheless, a new form of social conflictuality centred on the questions of risk has
arisen since society has been confronted with numerous unintended, the environmental
and human life threatening consequences of scientific and technological innovations.
Doesn't this situation confirm that technologies and competitiveness cannot
compensate for the lack of just social and environmental policies ? Doesn't it confirm
that these technologies are not shaped to solve long lasting injustices in society and
that conceiving public science policy in a solely industrial and commercial framework is
unjust and incommensurate ?
Technosciences, especially NST, and more widely converging technologies, oblige us
to question the very basis sense of research, innovation, progress and societal
development. We are increasingly conscious that we live in a limited world, on a planet
where the natural capital becomes a limiting factor. The needs of the most
underprivileged, the concerns of social and environmental justice, solidarity, diversity,
sustainability, human rights, alternative property schemes and the public request for
knowledge to manage our world more wisely must thus be integrated with research and
innovation. Rethinking innovation for human needs and democratising scientific and
technical choices are more relevant than ever before.
11
Nano-Divide: a question of justice?
Andreas Bachmann, ethic im diskurs, Switzerland
It is generally agreed that nanotechnologies are likely to have considerable effects on
economies and societies worldwide. However, how will these effects be distributed?
Some claim that the distribution will be extremely unequal. They fear that particularly
the developing countries may not benefit from the achievements of nanotechnologies –
just as they have not benefited from other technological achievements. As a result, the
technology gap between the poor and the rich may widen even further.
Plausible though it may seem, it remains to be seen whether this thesis of ‘nano-divide’
proves correct. This is an empirical question. From an ethical point of view, what is
relevant is the normative question whether the unequal distribution of (or access to)
nanotechnological products between developed and developing countries would be
unfair or unjust.
The answer will be: it depends. It would be unjust, for instance, if nanotechnological
products – such as water filtration systems using carbon nanotubes – that, once they
exist, could help meet basic needs such as the need for clean drinking water were
inaccessible to those in need because they are too expensive. The reason would be
that every human being has the same justified claim to have his or her basic needs
fulfilled. Justice here implies strict equality - and a corresponding moral duty to see to it
that this equality is guaranteed. It would not be unjust, however, if nanotechnological
products – such as sunscreens containing nanoscale titanium
dioxide for better UV-protection or computers containing nanoscale transistors – that
are not necessary for survival or a minimally decent life turned out to be too costly to
people in the developing world (or, for that matter, to poor people in the developed
world).
In its report on nanotechnology the UNESCO emphasizes that the patenting system
may turn out to be an almost insurmountable obstacle for developing nations with
regard to nanotechnological R&D: “The danger created by excessive patenting in
nanotechnology is that of the ‘patent thicket’ (…). Patents on basic nanoparticles and
processes using nanoparticles could end up being so finely and acutely propertized
that the ability to create a novel material [such as a water filtration system] could face
nearly unnavigable complexity in terms of competing and overlapping patent claims”
(UNESCO (2006), The Ethics and Politics of Nanotechnolgy, p.18).
This kind of ‘excessive patenting’ in nanotechnology may have two negative effects on
developing nations:
1) Nanotechnological research in developing nations may not be able to
compete with research in developed nations. As a consequence these
nations cannot develop products such as nano-based water filtration systems
that are needed in order to meet the basic needs of their population. They
completely depend on those who do have the means to develop products of
this kind.
2) These products, however, may be too expensive for the poor, not least
because of licensing fees due to patents.
12
If something like this happened it would bring about a ‘nano-divide’ that would be unjust.
How can this injustice be avoided? According to UNESCO one viable option is: “To
encourage – and amongst national governments, to require – open access to publicly
funded research results and materials”. One could even go one step further and
demand open access to privately funded research results as well - analogously to the
“Free and Open Source Software” that led to the development of the computer system
Gnu/Linux. Whether and how this option can be realized without generating new
injustices remains to be seen.
13
Nanotechnologies at the OECD
Rob Visser, OECD, Paris, France
The OECD has two programmes related to nanotechnologies: i) the activities of the
Working Party on Manufactured Nanomaterials; and ii) the Working Party on
Nanotechnology. These co-ordinated and mutually supportive efforts are intended to
provide the conditions for optimal safe development of this range of new technologies.
The main focus of this presentation will be on the activities of the Working Party on
Manufactured Nanomaterials (WPMN) which was established in 2006 as part of
OECD’s Environment, Health and Safety Programme. The objective of the WPMN is to
promote international co-operation in human health and environmental safety related
aspects of manufactured nanomaterials, in order to assist in the development of
rigorous safety evaluation of nanomaterials. The work is being implemented through
eight projects:








Development of a Database on Human Health and Environmental Safety
Research;
Research Strategies on Manufactured Nanomaterials;
Safety Testing of a Representative Set of Manufactured Nanomaterials;
Manufactured Nanomaterials and Test Guidelines;
Co-operation on Voluntary Schemes and Regulatory Programmes;
Co-operation on Risk Assessment;
The role of Alternative Methods in Nanotoxicology
Exposure Measurement and Exposure Mitigation
The safety of nanotechnologies is a global issue and consequently the need to meet
environmental and health safety objectives goes beyond OECD member countries. For
this reason, the WPMN is increasingly involving the participation of non-member
economies (to date, Brazil, China, the Russian Federation, Singapore and Thailand).
There is also strong communication with other international organizations such as the
other IOMC participating organizations (FAO, ILO, UNEP, UNIDO, UNITAR and WHO)
as well as UNESCO and ISO. The work benefits also from the inputs of BIAC (the
Business and Industry Advisory Committee to OECD), TUAC (the Trade Union
Advisory Committee to OECD) and Environmental NGO’s.
Detailed information can be found at: http://www.oecd.org/env/nanosafety/
14
International standardization - supporting safe and successful
nanotechnologies for all stakeholders
Dr Peter Hatto, Chairman ISO/TC 229 – Nanotechnologies,
IONBond Ltd., UK
By providing agreed ways of naming, describing and specifying things, measuring and
testing things, managing and reporting things, written, consensual standards support
commercialisation and market development, provide a technical, quality and
environmental basis for procurement, and support the development and introduction of
appropriate legislation and regulation.
The provision of a comprehensive standards infrastructure for nanotechnologies,
covering terminology and definitions, measurement and characterization, and health
and environmental safety, including protocols for risk and life cycle assessment, is seen
as essential to their commercial success. With such an infrastructure in place, industry
will be able to focus on producing innovative products in the knowledge that they have
the tools available to assure quality and evaluate and mitigate hazards and risks,
consumers will be able to have confidence in the efficacy and safety of nanotechnology
products, and regulatory agencies will have the necessary technical support for the
development of appropriate regulation. ISO/TC 229 has a dynamic work programme,
committee structure, and comprehensive standards development road map that will
address these three areas – terminology, measurement and characterization, and
health and environmental safety, together with (nano)materials specifications. The
committee’s work is coordinated with that of several ISO TCs and other relevant
international organisations whose own work has an impact on, or is impacted by,
nanotechnologies. This cooperation will help to ensure the delivery of harmonized
outputs relevant to the needs of all stakeholders.
15
Intergovernmental dialogue on nanotechnologies:
The case of the OECD Working Group on nanotechnology
Francoise Roure, Vice-President of the OECD Working Group on Nanotechnology
Nanotechnology is an emerging technology that has the potential to bring major
changes in many fields of application. The limits of the use of nanotechnologies as well
as their social use need the adoption of a normative and dynamic approach that applies
directly to the governments.
The socio-economic perspectives and the potential responses of nanotechnologies to
the big challenges of the millennium deserve to be apprehended in a balanced way by
defining in a cooperative framework the responsible, balanced and appropriate policies
that take into account the true value of the environmental, ethical and public health
aspects.
The public policies related to nanotechnology need to rely on a dynamic observation of
the evolutions in order to improve the public decision quality and to define the
regulatory framework for private decision-makers' activities. The international
dimension of nanotechnologies and the changes that result from the convergence of
nano-scale technologies with high transformational capacity, require a strengthened
international dialogue that explains all the aspects of the international nanotechnology
governance, included the responsibilities of every stakeholder.
The recently created OECD Working Group on nanotechnology aims to contribute to
the definition of the relevant indicators in order to improve the public decisions quality.
The Working Group has been organized in various dynamics that will be presented.
The first results are expected for the end of 2008, with an important working program
for the period 2009-2010.
These OECD dynamics that complete the work carried out in the framework of the
OECD Chemistry Committee are only one aspect of the international responsible
dialogue on nanotechnology. The impact and the efficiency of this dialogue are
conditioned by its really inclusive nature in a highly competitive world.
In this respect, the coordination of the nanotechnology policy among the different
specialized institutions of UNO could be a short term perspective and it will therefore
follow a dialogue that started in May 2008 on the consequences of the nanotechnology
development for the Southern countries. Since 2004, the international influence of the
process called Alexandria on the international responsible dialogue in the field of
nanosciences and nanotechnologies, supported by the European Union, has also
played a particularly useful role that needs to be reinforced.
16
Nanotechnology and manufactured nanomaterials - ongoing and planned work in
the UK
Jane Stratford, Defra, UK
The UK Government’s vision for nanotechnologies is “for the UK to derive maximum
economic, environmental and societal benefit from the development and
commercialisation of nanotechnologies, and to be in the forefront of international
activities to ensure there is appropriate control of potential risks to health, safety and
the environment”.
Nanotechnology was first identified as an area of great potential but where concerns
are likely to be raised about the risks of the technology in 2003. The then Minister for
Science and Innovation asked the Royal Society and the Royal Academy of
Engineering to conduct an independent study. Their report ‘Nanoscience and
nanotechnologies: opportunities and uncertainties’ was published in July 2004. It made
a series of recommendations for Government on improving evidence for possible
health, safety and environmental impacts; regulatory issues; social and ethical issues;
and stakeholder and public dialogue. The Government’s response set out an ambitious
agenda to address nanotechnologies and is subject to independent review after 2 years
and 5 years.
Nanotechnologies cuts across a range of Ministerial responsibilities. The UK
Government has therefore established governance arrangements to drive the agenda
forward:

Ministerial Group on Nanotechnologies: Established in November 2008 to provide
high level overview of Government activities. It includes Ministers responsible for
science and innovation, environment, worker health and safety and public health;

Nanotechnologies Issues Dialogue Group : Co-ordinates Government activities
across Departments, Regulatory Agencies and Research funders;

Nanotechnologies Research Co-ordination Group: Co-ordinates publicly funded
research into the potential risks presented by the products and applications of
nanotechnologies;

Nanotechnologies Stakeholder Forum: informs policy on control of potential risks
and maximising benefit; allows an exchange of information; represents the views of
all stakeholder communities with an interest, and improves the accessibility of
debate and discussion to the public.
From the outset the Government has wanted to understand and address public
aspirations and concerns for nanotechnologies we have therefore funded in-depth
discussions between members of the public, scientists and others. All leads to
increased transparency in policy development for nanotechnology.
17
NanoSafety in Thailand1
V 0.4 1 July 2008
Dr Lerson Tanasugarn, Chulalongkorn University, Thailand
Thailand is a Southeast Asian Kingdom that has evolved from a strictly agricultural
economy to follow the dream of becoming a newly-industrialized country. In the age of
nanotechnology, both the academic and industrial sectors are quickly investing
resources into development and production of various nanotechnology-based products
including nanocomposite food packages, nanosensors, water-repellent fabric coating
made of nanoparticles, nanoclay membranes for water treatment, and curcuminoid
nanoliposomes (whitening) face creams, nanoalumina-doped ceramics-based artificial
gemstones, nanochitosan-based slow-release drug vehicles, nanoparticle Organic
Light Emitting Diodes (OLEDs), and nanodye-sensitized solar cells, etc. Although
safety issues of nanotechnology and nanotechnology-based products have only
recently been discussed in limited circles, the country has a well-established framework
for hazardous material management that includes environmental hazards, health
hazards, and workplace hazards.
Governmental Offices and Bureaus responsible for dealing with these hazards are
affiliated with several Ministries and have formed networks for expediting their
responses. With regard to nano-hazards, The Thai National Nanotechnology Center
(NANOTEC) is the policy focal point and an active implementer. It has already
sponsored a Phase I NanoSafety and NanoEthics study that was conducted by
Chulalongkorn University. The study identified the issues, the global players, and the
present and future policy options that the country should consider. Currently NANOTEC
is sponsoring Phase II of the NanoSafety and NanoEthics study, where critical reviews
of related prior scientific studies are conducted in order to form a solid basis for
subsequent NanoSafety and NanoEthics Guidelines. Meanwhile, NANOTEC has set its
strategic goals for nanosafety research, including measurements of nanomaterials, risk
exposure measurements, toxicity determination, screening test developments, risk
assessments, and model validation. Thailand has thus set its course to become both
an informed consumer and a nanomaterial producer with social responsibility that is
compatible with global standards. Towards this end, the country needs strong
international linkages for best-practice information, research collaboration, as well as
standard and guideline development.
1.
Country Background
Thailand is a country in Southeast Asia with an area of approximately 514,000 sq km
(about the size of France) and a population of approximately 63 million at the end of
2007.
The country is the world’s No. 1 exporter of rice. Other major exports include textile and
footwear, fishery products, rubber, jewelry, automobiles, computer and electrical
appliances. The 2006 estimated nominal per capita GDP of Thailand is USD3,136 (or
USD 9,200 Purchasing Power Parity). Although Thailand is considered by many to
have graduated from a developing country into a Newly Industrialized Country (NIC)
status, there are still large gaps in the distribution of income, the development of
indigenous technological capabilities, and the level of research and development,
especially in the private sector.
18
Status of nanotechnology in Nigeria:
Prospects, Options and Challenges
Prof. Olusegun O. Adewoye, NASENI, Abuja, Nigeria.
This paper presents the positive efforts made by the Federal Government of Nigeria on
the present status of Nigerian Nanotechnogy Initiative (NNI). Through the National
Agency for Science and Engineering Infrastructure, the coordinator of this initiative;
meetings and workshops have been organised where viable nanotechnology options
for Nigeria as well as the needed research and development infrastructures relevant to
each option were established. Efforts made by NASENI to increase the visibility of the
NNI within the government circle and amongst the scientists and engineers within
Nigeria and in the diaspora will be highlighted. Policy and scientific challenges facing
the NNI will be discussed. Finally, recommendations for rapid take-off of this initiative
will be made.
19
History and current status of Nanotechnology in Russia
Contribution to global dialog on EHS issues
Marine Melkonyan, A.V. Shubnikov Institute of Crystallography of RAS,
Moscow, Russia
Nanosciences and Nanotechnologies (N&N) in modern Russia have a long history of
the governmental support. In 2007 a national initiative on the development of
nanoindustry in Russia has been announced. The strategic goal of this initiative is to
create the nanoindustrial sector, which would be able to compete with those of
economically developed countries on the internal and international markets of
nanoproducts. The following programmes are the main tools of the governmental
support of N&N (http://www.spbcas.ru/nanobio/Nanobio08/Abstracts_all.pdf):
-
-
Federal Targeted Programme “Research & Development in priority fields of
Russia’s S&T Complex 2007-2012”, “Industry of Nanosystems and Materials”
sub-programme
Federal Target Programme “Development of the Infrastructure of Nanoindustry
in the Russian Federation for 2008-2010”;
Federal Space Program of Russia for 2006-2015;
Federal State Program for Development of Defense-Industrial Complex of the
Russian Federation for 2006-2010;
Specialized Programmes of the Russian Academy of Sciences;
Programme of the Russian Academy of Medical Sciences “Nanotechnologies
and Nanomaterials in Medicine” for 2008-2015.
Some years ago the evaluation of Nanotechnology risks for the environment and
human health was not a priority in Russia. The first event in Russia, devoted to the
risks and benefits of N&N in the frame of XII National Conference on Crystal Growth in
Moscow (October 2006), demonstrated that Russian scientific community has
recognized the importance of studies of Nanotechnology potential impacts on human
health and environment. In Russia there is not currently research Programme
underway to address human health and/or environmental safety aspects of
Nanomaterials. But a number of R&T projects on impacts of nanomaterials are funded
by Russian Foundation for Basic Research; by Federal Agency for Science and
Innovation. Studies of physico-chemical properties of nanomaterials (in particular,
nanoparticles) have been carried out within Russian Academy of Sciences (RAS).
Some researchers are including toxicological, ecotoxicological and metrological
aspects on Nanotechnology in their research, but there is no official network for these
areas. A number of Russian organizations are the partners of the international projects
on
analysis
of
toxicity
of
nanomaterials,
funded
by
ISTC
(http://search.istc.ru/index.jsp?v=7).The special session “The international dialog on
Nanotechnology risk assessment and management: opportunities for Russia” was held
in the frame of the Second International Conference on Nanobiotechnologies” in SaintPetersburg (June 16-18, 2008, http://www.spbcas.ru/nanobio). This event was
highlighted that there is the need and opportunity for Russia to join the international
forum on the possible societal, health and environmental impacts of Nanotechnology.
Some recommendations have been developed how to establish the national network
for the area of Nanotechnology risk assessment; how to promote joining of Russia to
the bodies responsible for international cooperation on environmental, health and
safety impacts of Nanotechnology.
20
Current Status and Perspectives of the Nanotoxicity Research in Korea
Kyung-Hee Choi, Ministry of Environment, Republic of Korea
The Korean government well recognized the importance of potential risks of
nanomaterials, and is conducting several projects on human health and environmental
safety of nanomaterials.
Ministry of Environment (MOE) has organized ‘inter-ministerial policy consultation body’
for proper management of nanomaterials/nanotechnology among relevant ministries.
MOE started projects on human health and environmental safety of nanomaterials. The
ultimate goal of this research is to support the establishment of infrastructure necessary
to minimize potential risks derived from the manufacture, distribution and disposal of
nanomaterials and nanomaterials-containing products. The research project includes:
1)
identification of environmental release of manufactured nanomaterials;
2)
characterization of physico/chemical properties of nanomaterials;
3)
development of monitoring methods of nanomaterials in air and water;
4)
(eco) toxicological assessment of nanomaterials by systematic molecular
biology;
5)
environmental exposure and fate of nanomaterials including LCA, and
6) preparation of test guideline for the risk management of nanomaterials. The project
is designed that results would be used for the supportive data to international
cooperation activities of OECD WPMN.
The Ministry of Education, Science and Technology (MEST) has performed a research
project named ‘environmental implications assessment of nanomaterials’. The outputs
of the project include:
1)
the characteristics of nanomaterials;
2)
the domestic and overseas trends in industrial, social, pharmaceutical, human,
and environmental effects on nanomaterials;
3)
need for research on human health and environmental safety, and
4)
a proposal for a new institute to address negative effects of nanomaterials.
Korea Food & Drug Administration (KFDA) is conducting a series of research projects
on the toxicity of nanomaterials from 2007 to 2015 aiming for the development of a
toxicological assessment system of nanomaterials and establishment of the related
guidelines for the area such as food, drug, medical product, and cosmetics. As a
Korean representative for ISO, Korean Agency for Technology and Standards (KATS)
has conducted works related to ISO/ TC 229. KATS submitted two standard proposals
to ISO/TC 229. In the presentation, recent progresses of the nanosafety projects
undergoing in Korea will be introduced.
21
The small and the risk - A view from the re/insurance industry
Dr. Thomas K. Epprecht
Swiss Reinsurance Company, Zurich, Switzerland
Nanotechnology has become a major engine for economic growth. As an enabling
technology it encompasses many disciplines and industries. The challenge is to master
an increasing variety of nano-enabled products, and to identify potentially harmful
properties that are currently neither well analysed, described or understood, nor
regulated or differentiated from other, safe properties.
Swiss Re promotes the development of tailored risk management principles and
supports regulatory efforts to prevent unknown exposure and ensure a balanced public
dialogue on possible risks. Because progress is gathering pace, currently covered
nanotechnology risks affect an ever wider variety of insurance policies and reinsurance
treaties, and influence return on assets.
As the leading reinsurance risk carrier, Swiss Re strives to be at the forefront of efforts
to identify and understand the insurability challenges posed by nanotechnology and
other emerging risks. At the same time, industry, risk research and regulators have
stepped up their efforts to obtain a clearer picture about undesirable side-effects of
nanomaterials and measures to govern risks appropriately.
Insurance is a vital element in safeguarding economy and society over the long-term
against the financial consequences of adverse events, and to enable them at large to
take the risks that allow them to move forward. Swiss Re therefore believes that all
parties with an interest or stake in safe nanoproducts must intensify dialogue and
collaboration, to develop risk governance rules and adapt institutional and regulatory
gaps where necessary.
Find more about Swiss Re’s perspective in:
http://www.swissre.com/pws/about%20us/knowledge_expertise/top%20topics/nanotech
nology/nanotechnology.html
22
Role of National Nanotechnology Center (NANOTEC) and the Code of Conduct
for Responsible Nanotechnology in Thailand
Dr. Noppawan Tanpipat
National Nanotechnology Center (NANOTEC)
THAILAND
The potential and rapid growth of nanotechnology may far outpace the new information
and knowledge gained on its associated safety and health risks. As one preventive
measure, timely targeted on Health, Safety and Environment (HSE)-research for
nanomaterials is needed in defining risks and providing guidance for safe handling of
nanomaterials. A concerted effort is needed by industry, academia, government and
NGO to identify and address the existing knowledge gaps in a transparent and credible
process that coincides with such development of this new technology. The National
Nanotechnology Center (NANOTEC) will play an active role in this course of action
through the conduct of scientific research in nanomaterials safety with regards to health
in addition to policy and strategies to protect the researchers and workers alike.
NANOTEC, however, is not a regulatory agency but a national research center and a
granting agency, it therefore relies heavily on efforts made by others in achieving the
ultimate outcomes for the workplace safety and preventive measures for health. With
serge in public needs for awareness in nano-safety, NANOTEC strategically put
together a development plan that includes a roadmap for risk assessment in the
potential nanoscience and nanotechnology (N&N) applications for the advancement of
occupational safety and health in the workplace. The complementary NANOTEC nanosafety research findings and the existing guidance are utilized in establishing a protocol
for safety conduct coordination in N&N research across the Center. In addition, it is
intended to be employed as a monitoring tool for emerging research development in
response to new challenges in N&N. Meanwhile, the strategic plan will have a cohesive,
multidimensional, and timely nanomaterials research agenda that will properly address
the information and knowledge gaps concerning possible exposures of nanomaterials,
health risks from such exposure, whilst also development of control and prevention
measures to protecting Thai citizens from potential harms related to nanotechnology.
23
Nanotechnology in a Developing Country – Applications and Challenges
Babajide I. Alo, University of Lagos, Nigeria
Developing countries and countries in transition are making some halting progress in
adopting and mainstreaming nanotechnology options in the respective national
development agenda. However, as commodity production and workable low-tech
alternatives remain the backbone of most developing nations, this paper will provide a
short review of the current dilemma in balancing the opportunities, social utility, risks
associated with and the potential profound effects of adoption of nanotechnology in a
limited developing economy.
The paper contends that global policy responses for nanotechnology need to promote
responsible actions regarding this innovative enabling technology, including increased
awareness and full dialogue, justification of relevance and import to developing
economies, together with the possible challenges including socioeconomic and
ecological issues surrounding new technologies that could have an impact on the
world’s poorest and most vulnerable.
24
Download