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Nanotechnology and manufactured Nanomaterials:
Opportunities and Challenges
IFCS Forum VI
THOUGHT STARTER1
(LENGTH: 12 to 15 PAGES MAXIMUM)
NOTE to WG:
o Please insert suggested revisions; additions and comments directly into the text
using track changes.
o See several questions/request for specific information & comments imbedded in
text
Objective of a plenary session
The objective is to exchange information in order to help raise the awareness of participants
to the potential new opportunities, the new challenges and the new 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.
1
Thought Starter papers are intended to provoke thought and bring about discussion. Thought Starter
papers are not an in depth analysis or comprehensive review of the topic.
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Table of Contents:
1
2
3
4
5
6
7
8
8.1
8.2
8.3
8.4
8.5
Background
Ethical considerations
Social utility of nanotechnology
The state of the knowledge about the risks of nanomaterials
Communication and public dialogue
Activities of international organizations
National activities, interests and priorities on nanotechnology and manufactured
nanomaterials
Annex
Definitions and types of nano material
Health risks
Occupational health
Environmental risks
Ethical issues
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1
Background
Nanotechnology is an enabling technology that is expected to result in major changes across
many industry sectors and to contribute to novel materials, devices and products. Depending on
the area of application there are different timelines for the beginning of industrial prototyping and
nanotechnology commercialization. 1st generation products are already on the market such as
paints, coatings and cosmetics. More products such as pharmaceuticals, diagnostics, applications
in energy storage and production are in development. Further generations of nano-enabled
products based on active nanoscale structures and nanosystems will be developed in the future.
Such developments will address innovations looking into processes of technical modernization
and changes in the interface between humans and machines/products. Presently discussion on
opportunities and challenges of nanotechnology and manufactured nanomaterials focuses on 1st
generation nanoproducts. The thought starter gives an overview of the topics relevant for this
discussion. The scope does not include the area of medical diagnostics and treatment as this is
being addressed in other fora.
Nanotechnologies and manufactured nanomaterials may bring many advances to society and
benefits for the environment, but also poses new challenges in health, environment safety and
new interrogations on possible impacts on society. While discussion on benefits usually focuses
on individual technology applications, discussion on heath and environmental risks may be more
broadly expanded to nanomaterials generally. 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 policy
issues that may impact health and safety in positive or negative ways as well as moral, ethical,
societal, legal issues and social usefulness for everyone.
In view of the predicted great impact of nanotechnologies on the global economy, research and
society, and of the expected wide-spread use of nanomaterials, any possible risks should be
studied by comprehensive, proactive risk estimation and assessment.
2
Ethical considerations
Only a few ethical committees have struggled with the ethical challenges posed by this
technology. A number of prestigious reports (e.g. UK Royal Society) and coalitions (labour ,
environmental, and civil society groups) have advocated for the precautionary principle to apply
to development and commercialization of engineered nanoparticles. The precautionary principle
and the discussion on socially acceptable or unacceptable risks are often discussed in ethical
committees. Other issues identified as priorities for discussion include: the social and global
distribution of benefits and risks, ownership/patent issues, health and safety risks to workers and
the public, regulatory oversight, moratorium on technological applications. (see Annex 8.5).
3
Social utility of nanotechnology
The way in which we use available natural resources has effects on our health and the
environment. Natural resources are an important factor in the economy and an important element
of our welfare. Technological innovations can play a key role in the more efficient use of our
resources.
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Before the development or use of any application from nanotechnologies, the question of social
utility should be asked. To answer that question the potential contribution of such applications to
solve a specific socially relevant problem such as climate change, water shortages and starvation
should be known. Health and environmental risks and possible side effects on society and
economy should be taken into account as well as existing alternative solutions. The result of such
an evaluation will always be country specific.
4
The state of the knowledge about the risks of nanomaterials
Materials are used at nanometric scale for their new properties. One can expect effects of the
same level on health and environment.
Various studies have shown that, because of their small size, unbound nanoparticles can be
inhaled and enter the bloodstream via the lungs, disperse throughout the body and penetrate other
organs. It has also been shown that, depending on their properties, some manufactured
nanoparticles can be damaging to cells. Little data is available on the toxicology, release,
environmental behavior and safety of nanomaterials. Although a few studies have been carried
out, not all of their results are meaningful, since many of these investigations were carried out
using very high concentrations of particles, and with samples or reference materials that had not
been accurately characterized (see Annex 8.2, 8.3, 8.4). Several countries have launched research
programmes to reinforce independent risk research (see point 7).
In the literature it is often stressed that results for one nanoparticle cannot be generalised to other
nanomaterials. This is mainly because the characteristics that influence toxicity have not yet been
defined. Standardised test protocols and standardized reference compounds would enable
comparisons to be made between the different materials and studies. International organizations
such as OECD and ISO and national agencies have established programmes to fill this gap (see
point 6).
Based on the scientific and methodological principles currently available, no conclusive
requirements for the safety of manufactures nanomaterials can yet be formulated. Nevertheless,
safety precautions must be taken. As soon as the conditions for well-grounded risk assessments of
manufactured nanomaterials are present, statutory framework conditions for the safe handling of
such materials should – where necessary – be created.
5
Communication and public dialog
Broad information on opportunities and risks of nanotechnology and nanomaterials is important
for public opinion making. Communication is a key prerequisite for the public engagement with
new technologies. This opinion-forming process may leave its mark on the development of
technologies and their application. Communication should therefore extend further than the field
of manufactured nanomaterials to encompass all of nanotechnologies. It should reflect the current
state of social, scientific and political knowledge and of public engagement. Account should be
taken of both the promise of nanotechnologies and the public fear or rejection it may create.
The involvement of industry, authorities and the public in the debate on opportunities and risks
must be an integral part of technological development. For an integrated approach, this debate
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should be as broad as possible and not restricted to individual levels or topics (e.g. scientific,
psychological, sociological). A challenge is to communicate information on risks and benefits to
enable a public dialogue and informed decisions; the challenge will be even more difficult in
developing countries.
6
Activities of International Organisations2
Peter Kearns - please add text to describe the work OECD is doing in the area of OSH. Thank
you.
OECD has established under its Chemical Committee a Working Party on Manufactured
Nanomaterials (WPMN). It aims to promote human health and environmental safety implications
of manufactured nanomaterials in order to assist in their safe development (limited to mainly the
industrial chemicals sector). The following six projects are in the workplan of the WPMN:

Development of an OECD Database on Human Health and Environmental Safety (EHS)
Research

EHS 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
OECD’s Committee for Scientific and Technological Policy has established a Working Party on
Nanotechnology (WPN). Its aim is to look at the responsible development and use of
nanotechnology and the potential benefits nanotechnology can bring to society, taking into
account public perceptions related to advances in nanotechnology and its convergence with other
technologies, without forgetting legal, social and ethical issues. The following projects are in the
work plan of the WPN:

Statistics and Measurement

Impacts and Business Environment

International Research Collaboration

Outreach and Public Engagement

Dialogue on Policy Strategies

The Contribution of Nanotechnology to Global Challenges
ISO has established Technical Committee 229. Currently the following 3 working groups have
been established: terminology and nomenclature; measurement and characterization; and, health,
safety and environmental aspects of nanotechnology. 10 work items spread across these three
work areas are currently under development.
UNESCO is being invited to revise/add text as appropriate.
(text taken from UNESCO website)
2
At the June 2007 FSC meeting G. Karlaganis, lead sponsor, invited the IOMC organizations to prepare an
information paper on work ongoing in their organizations. R. Visser agreed to prepare a paper on OECD
activities and to discuss the request with other IOMC organizations.
ISO is invited to provide a separate information paper on its ongoing and planned work.
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UNESCO Ethics of Science and Technology Programme3 was created in 1998 with the
establishment of the World Commission on the Ethics of Scientific Knowledge and Technology
(COMEST) to give an ethical reflection on science and technology and its applications.
This programme aims to promote consideration of science and technology in an ethical
framework by initiating and supporting the process of democratic norm building. This approach is
founded upon UNESCO's ideal of "true dialogue, based upon respect for commonly shared values
and the dignity of each civilization and culture". Awareness raising, capacity building and
standard-setting are therefore the key thrusts of UNESCO's strategy in this and all other areas.
UNESCO has invited well-known experts in nanotechnology to discuss the state of the art of
nanotechnology, examine the controversy surrounding its definition and explore related ethical
and political issues. A 2006 report “The Ethics and Politics of Nanotechnology”4; "outlines what
the science of nanotechnology is, and presents some of the ethical, legal and political issues that
face the international community in the near future." UNESCO has recently published a book on
"Nanotechnologies, Ethics and Politics"5. The aim of the book is to inform the general public, the
scientific community, special interest groups and policy-makers of the ethical issues that are
salient in current thinking about nanotechnologies and to stimulate a fruitful interdisciplinary
dialogue about nanoscale technologies among these stakeholders.
7
National activities, interests and priorities on nanotechnology and manufactured
nanomaterials
The following information contributed by a select number of countries is presented to provide a
brief introduction to ongoing and planned work as a general indication of some approaches being
taken. An OECD document provides detailed information on current/planned activities related to
the safety of manufactured nanomaterials in OECD member countries, as well as those nonmember countries who are participating in OECD’s work6.
Belarus
(to be completed)
3
http://portal.unesco.org/shs/en/ev.php-URL_ID=10581&URL_DO=DO_TOPIC&URL_SECTION=201.html
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf)
5
http://portal.unesco.org/shs/en/ev.php-URL_ID=10883&URL_DO=DO_TOPIC&URL_SECTION=201.html
4
6
Current Developments/ Activities on the Safety of Manufactured Nanomaterials, Berlin, Germany, 25-27
April 2007 http://appli1.oecd.org/olis/2007doc.nsf/linkto/env-jm-mono(2007)16
This document provides information on current/planned activities related to the safety of manufactured
nanomaterials in OECD member countries. Information was provided by delegations who participated in
the 2nd Meeting of OECD's Working Party on Manufactured Nanomaterials. There are also reports on
relevant current activities in other International Organisations such as the ISO. In addition, delegations
added a short list of highlights at the top of their submissions to give readers a general idea of key events
since the 1st meeting of the Working Party. (website accessed 07.09.24)
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China
1. The adjustment of government regulation concerning product classification for medical
devices made with nanometer biological materials
According to the notice of the State Food and Drug Administration of China (SFDA) announced a
notice (document number 146, 2006), the classification of medical devices made with nanometer
biological materials (for example medical instruments made with nanometer metal silver
material) will be adjusted from Class II medical devices to Class III medical devices, and they
should be subject to the administration of Class III medical devices.
2. The standards on nanotechnologies
Up to date China government has published 15 standards on nanotechnologies, of which 11 are
national standards and 4 are industrial standards.
3. Research on the nanotechnology safety
With the rapid development of application fields of nanotechnologies, as has happened in many
other countries, the issue of nanotechnologies has given rise to serious public and governmental
concern. Researchers from the Chinese Academy of Sciences (CAS) initiated activities to study
the environmental and toxicological impacts of manufactured nanomaterials in 2001, including
recognition, identification and quantification of the biological and environmental hazards
resulting from exposure to diverse nanomaterials/ nanoparticles. Currently, more than 30 research
organizations in China have initiated their own research activities studying the toxicological and
environmental effects of nanomaterials/ nanoparticles, and techniques of recovering nanoparticles
from manufacturing processes.
European Union
(to be completed)
Germany
The German Federal Environment Ministry launched the NanoDialogue project last year on
behalf of the Federal Government. The aim is to provide support through the NanoCommission,
to the sustainable development and use of nanomaterials. The NanoCommission is made up of
academics, industry representatives, environmental and consumer associations, employees'
representatives, federal representatives and the Länder. The NanoCommission has set itself three
tasks. For these tasks, special working groups were installed:
1. The 1st working group concentrates on the question: How can using nanomaterials
contribute to sustainable economic and social development in Germany, in particular as
regards environmental/health and consumer protection? For instance, nanomaterials are
already being used to improve photovoltaics installations; they also promise to make
improvements to energy storage equipment and batteries.
The "Opportunities for the Environment and Health" Working Group wants to identify
and describe select nano-enabled products or applications from which we can derive a
special benefit for the environment, for consumers and as regards health protection.
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Because in some areas nanomaterials are still at an early stage of development, future
potentials also need to be identified for this sector in Germany.
2. Where do we need to do risk and safety research to clarify the possible impacts on the
environment and health from using nanomaterials? A second working group is called
"Risks and Safety Research" and consequently deals with the possible risks posed by
nanomaterials, especially the gaps in our knowledge, which we need to fill as soon as
possible.
The aim is to work out a joint programme for future safety research plus suggestions for
concrete projects. Since many products with nanomaterials are already on the market and
we expect a further increase in the future, this working group wants also to give first
recommendations regarding risk assessment for nanomaterials.
One key difficulty in assessing the possible risks posed by nanomaterials is that in some
cases new test and evaluation methods need to be developed. These include suitable
means for measuring nanoparticles in environmental media and on/in the human body, as
well as developing appropriate measuring and assessment strategies.
3. In order to provide preventive protection to employees, consumers and the
environment, a third group is working on "Guidelines on the Responsible Use of
nanomaterials". The group started the work on existing Guidelines for employment
protection and is now working on basic principles on which Guidelines should be based
and on indicators, for checking their implementation.
Possibly the result will be recommendations for dealing with lack of knowledge, possible
“no-go areas” for release of nanomaterials into the environment or for potential damages
for humans will be identified. But “No-go areas” could otherwise mean that there are also
some kind of “innovation-spaces”, where the experts see few risks and where the
advantages preponderate. The aim of working group 3 is that Industry and user
Companies adopt this Guidelines as a “Code of Good Practice”.
The NanoCommission is very interested in initiatives of the OECD, the EU and other states in
this area and wants to incorporate this into its work. In addition different Government/Industry
funded projects are ongoing where nanomaterials are tested like Nanocare, Inos and Tracer and
some Government or industry funded work in this area. This is embeded in activities of the EU.
Japan
(to be completed)
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) implemented a new project on the safety of manufactured
nanomaterials in the framework of Ecotechnopia 21 project which has been conducted to promote
the development of environmental technologies since 2001. Ministry of Science & Technology
(MOST) has performed a research project named environmental implications assessment of
nanomaterials from 2006. Ministry of Commerce, Industry and Energy (MOCIE) has conducted
research designated in ISO/ TC 229. Korea Food & Drug Administration (KFDA) has carried out
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a series of research projects on the toxicity of nanomaterials from 2007 to 2015 with the aim of
the development of a toxicological assessment of nanomaterials and guidelines for the areas such
as food, drug, medical product and cosmetics. In order to harmonize the policy on the safety of
nanomaterials in Korea, MOE, MOST, KFDA and MOCIE established an inter-ministerial
consultation body on the safety of nanomaterials in March 2007. The consultation body will play
an important role to perform effective research and to develop harmonious policy in the
nanosafety.
Issues covered by MOE, MOST, MOCIE and KFDA
- to characterise nanomaterials
- to establish test guidelines for the areas such as food, drug, medical product, and cosmetics.
- (eco) toxicological assessment of nanomaterials
- environment exposure and fate of nanomaterials
- risk management of nanomaterials
- survey the domestic and overseas trends on nanomaterial hazards
Nigeria
In Nigeria, just like in many developing countries, the challenges and prospects of
nanotechnology are still a very grey area with very limited ongoing national activities and little
information on any existing activities. It is expected that the Forum session will provide an
avenue for Nigeria and other developing nations to obtain information on the import and
relevance of nanomaterials and for accessing available opportunities for capacity development in
nanotechnology at the national and regional levels.
Some of the key areas of interest and challenges will be to: raise awareness on the subject matter,
justify the relevance and import of nanotechnology to developing economies, identify any
ongoing activities and expertise in this area, identify key stakeholders for capacity development,
develop programmes of action for public and private sector buy-in with the main considerations
for accruing benefits to the environment and human health.
Slovenia
Slovenia lunched the first activities in the field of nanosafety in 2004 with participation in EU
Accompanying Measure (GROWTH PROGRAMME): NANOSAFE - Risk Assessment in
Production and Use of Nanoparticles with Development of Preventive Measures and Practice
Codes) and its continuation as Integrated project: NANOSAFE 2 - Safe production and use of
nanomaterials (2005-2009) and Co-ordination action IMPART - Improving the understanding of
the impact of nanoparticles on human health and the environment (2005-2008). A partner in all
these EU projects is Jozef Stefan Institute (www.ijs.si ).
On 4th and 5th September 2006 National Chemicals Bureau organized the International
Conference on Chemical Safety and Safety of Nanomaterials. The conference was the final step
of an intensive project Phare Twinning “Chemical Safety II”, No. SI 03 IB EC 02, which had
been supported by the European Commission. The main twinning partners Slovenia and Austria
with about 60 short term experts from 10 EU Member States had worked together with numerous
experts from the Slovene working groups in different intersectoral priority areas of chemical
safety. After the conference work went further and the book "Slovenia is made for
nanotechnology" was published. Transition Facility Twinning "Advanced Chemical Safety -
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Third Stage Project" (in short “Chemical safety 3”), No. SI 06 IB EC 02, which started on 4th
June 2007, expects that a brochure on safety of Nanomaterials in Slovene language might be
prepared and published, that national strategy for nanomaterials is prepared, and that safety and
that overall awareness on risks posed by nanomaterials is raised.
The first national workshop on toxicity of nanoparticles organized by University in Ljubljana,
Faculty for biotechnology, Jozef Stefan Institute, National institute for chemistry, and National
institute for biology, was held on January 30, 2007 in Ljubljana. We have established a network
of all researchers focused on the interaction of nanoparticles with living cells. The report was
published as an article on literature survey in the topic including our research results in national
journal Delo with 65.000 subscribers.
Public lectures about toxicity of nanoparticles and basic recommendations for their safe
production and use have been given at two basic research institutions (Jozef Stefan Institute Febr. 2007, National Institute for Chemistry – March 2007), where nanotechnology studies
already started and at the Chamber of Craft of Slovenia – February 2007, with emphasis on
nanoparticles released in industry as a side product or pollution. Résumé of the lecture was
published in national journal Delo with 65.000 subscribers and in journal Obrtnik (specialized
journal for Chamber of Craft) with 53.000 subscribers. Basic information on concerns relating to
health risks of nanoparticles was published also on the website www.energetika.net, April 30,
2007 and released by national radio station RTV Slovenia, February 1, 2007.
In 2006/2007 we created a technological platform I-TECHMED: Innovative and Supportive
Technologies for Medicine (http://www.itechmed.net/eng/index.aspx?menu=ep ).
The goal of the platform with 50 involved public and private organizations is to establish an
efficient public-private partnership and to unite key stakeholders, who have a joint vision of
technological development for a particular sector, under the leadership of industry. In the work
group titled: Nanotechnologies for medical applications, the partners are decided to balance the
positive and negative impacts of nanoparticles on health considering ethics risks coupled with
enhanced chemical activity with decreasing the size of nanoparticles used as drug deliveries.
Nanoparticles in medicine are either engineered if they are prepared for specific purpose, as
example in drugs or creams, or they can be a side product of friction, as implant debris.
The first course of nanotoxicology at University in Ljubljana with the expected students in school
year 2008-2009 is currently in the preparation stage.
The action plan of Slovenia covers the following issues:
-
To register all producers of mass quantities of engineered nanoparticles synthesizing for the
market
To establish a national network on safe production and use of nanoparticles
To prepare recommendations for producers and users of nanoparticles
To recommend the size-distribution measurements of NPs at work place and in environment
To prepare the monitoring strategies at the production plants (personal sampling is preferred
to ensure an accurate representation of the worker’s exposure).
Dissemination of awareness of possible risks of nanotechnology to the public of developed and
developing countries should be coupled with positive aspects of technology, especially in
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establishing monitoring mechanisms and tools for detection of ultrafine particles in the
atmosphere. It should be noted that such particles are released in large quantities in industrial
processes, combustion, and explosions, but their detection is very limited, mostly due to the lack
of established detection mechanisms and because of lack of awareness of the need for monitoring.
Instrumentation for monitoring is needed and should be more sophisticated, although some
instruments are already on market, so the first monitoring is possible. The recommendations that
the atmosphere in production plants, where engineered nanomaterials are produced should be
monitored using of state-of-the-art equipment is necessary, and the same recommendation in
classical industry should be disseminated. This would open many concerns regarding safety at
work place, but it is time to open them. Exactly the combination of risks of intentionally produced
nanoparticles and those non-intentionally released would represent a safe basement for balanced
acceptance of nanotechnology by the public, and simultaneously push the regulations in direction
of better protection of workers.
Switzerland
In Spring 2006 work on the Swiss Action Plan was officially launched. A work package is
developed in collaboration with experts and stakeholders in order to identify critical applications
of manufactured nanomaterials and to minimize possible detrimental effects on human health and
the environment. The coordination of this work package with international organizations (OECD,
ISO) and EU is important. The promotion of safety research on manufactured Nanomaterials and
the dialog with the public and stakeholders are other objectives of the Action Plan. The first
deliverable of the action plan was a basic report, published in July 2007 (http://www.umweltschweiz.ch/nanotechnologie), containing an overview of the current knowledge about the risks of
manufactured nanoparticles. Topics discussed are human toxicity and ecotoxicity of
nanomaterials, occupational health and safety, regulation and standardisation, the assessment of
the consequences of technology and communication. Finally, a list of risk research needs is
presented.
Present Swiss legislation does not take the specific properties of manufactured nanomaterials into
account. The action plan of Switzerland covers the following issues:

Product information for consumers

guidance for self-supervision

information about manufactured nanomaterials on the material safety data sheets

maximum tolerable concentrations at the workplace

regulation of waste disposal

obligations to report, notify or authorisation (test requirements, special procedures for the
registration of nanoparticles)

limitation of emissions into the environment

regulation on major accidents (tonnage thresholds)
Thailand
(to be completed)
United Kingdom
The UK aims to promote the responsible development, use and fate of nanomaterials while
protecting people’s health and safety and protecting the environment. A key objective is
managing any potential risks to the environment and human health via the environment.
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Implementation of Government activities on nanotechnologies is co-ordinated through the
Nanotechnology Issues Dialogue Group (NIDG) made up of Government departments, agencies
and the devolved administrations. Progress and delivery was independently reviewed after two
years and will be reviewed again after five years.
There is currently little evidence on which to determine the potential risks posed by engineered
nanoscale materials. It is therefore difficult to assess the extent to which current controls and
regulations cover these materials, or the type of additional measures that may be necessary to
control potential risks. To address this, the UK has developed a comprehensive programme of
research on potential risks and a Voluntary Reporting Scheme for engineered nanoscale materials.
The UK Government funded around £10 million of Environment, Health and Safety related
research between 2005 and 2008. This sat alongside major funding for research into the
fundamental science behind the nanotechnologies through the UK Research Councils, which
provide the bedrock on which nanotechnology research is growing in the UK. The UK has
identified 19 Environmental, Health and Safety research objectives and developed action plans to
meet them. A second Government research report which places UK activities into an international
context was published in November 2007.
The UK Voluntary Reporting Scheme was established for industry and research organisations to
provide information relevant to understanding the potential risks posed by free engineered
nanoscale materials. The scheme is voluntary and will not replace existing legislation. It has run
from September 2006 to September 2008.
All policy activities are informed by an ongoing programme of stakeholder involvement, centered
around meetings of a Nanotechnologies Stakeholder Forum. This group is made up of key
stakeholders from industry, civil society groups and academia. Stakeholder involvement is
complemented by work to ensure wider public dialogue on the role and management of
nanotechnologies in society. As part of this, a Nanotechnology Engagement Group was funded to
draw together and reflect on a variety of public engagement projects, and then feed key
conclusions back to Government.
The UK recognises that the challenges posed in ensuring the responsible development of
nanotechnologies is too great to be solved by any one country alone. This is why we have been
working with international partners, in particular, the European Commission and the OECD to
share efforts and avoid duplication.
Further details may be found at: www.defra.gov.uk/environment/nanotech/index.htm
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8
8.1
Annex
Definitions and types of nano materials
Note to WG - in particular Peter Kearns. During the last WG teleconference it was requested to
include information on the different types of nano particles (size & shape) in the annex. P.
Chemin recommended using the information in a Canadian institute publication (reference
awaited). Should this reference be used or are there OECD "working definitions/descriptions" that
would be more appropriate to use? The "definition" text on nanotechnology is taken from the
2006 UNESCO report - is this acceptable?
Nanotechnology7
"There are currently dozens of different definitions of what nanotechnology is or could be; and it
is important to realize that none has been agreed upon. Definitions are also political and ethical –
they can determine what people will pay attention to, worry about, ignore or investigate. The fact
that there are many definitions is a good indication that nanotechnology (like other emerging
sciences such as biotechnology) will likely confuse the settled categories of pure and applied
research, and of publicly and privately funded research. Different disciplinary backgrounds and
different national scientific establishments will bring different concerns and ideas to bear on what
nanotechnology will become."
The UNESCO publication describes at least five definitions in use and notes that " Different
groups define nanotechnology differently, depending on what they hope it will achieve …..
These definitions also vary according to the interests of nations and social actors interested
in nanotechnology…"
Types of nano materials
(to be completed)
8.2
Health risks
In addition to the dose and the elemental composition of the nanoparticles, factors such as their
surface area, the function of the surface, tendency to aggregate, the form of the particles and their
surface charge all play decisive roles in their distribution through the body, and their possible
(genetic) toxicity.
For most nanoparticles it is not clear whether and how they are taken up in the body, distributed,
metabolised, accumulated and secreted. Kinetic models can help in the estimation of realistic
doses of particles in target organs that could be affected. Thus, the question can be resolved of
which exposure paths are relevant for various nanoparticles and whether certain target organs can
be excluded (for the moment), when setting the first priorities. In addition to particles themselves,
the potential health and ecological impacts of their breakdown products (metabolites in biological
systems, and degradates in ecosystems) also have to be considered.
7
The Ethics and Politics of Nanotechnology (UNESCO, 2006)
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf
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The lungs are the primary target site for inhaled nanoparticles, although there is also evidence of
some inhaled nanoparticles being transported from the nasal passages into the brain (discussed
below). Lungs have an enormous exposed area, and inhaled and deposited nanoparticles can get
into the bloodstream through the extremely thin air-blood-tissue barrier. From the bloodstream,
some nanoparticles have been shown to penetrate lipid bi-membranes and get into organelles such
as mitochondria and nuclei, which can cause oxidative stress or damage to DNA. Many studies
using animals or cell cultures have reported oxidation stress and inflammation reactions following
nanoparticles exposure. In addition to the lungs, the skin provides a potential uptake surface
following dermal exposures (such as for cosmetics, sunscreens, and nanoparticle-impregnated
clothing). Studies thus far report that nanomaterials do not penetrate through the skin very
efficiently; however, studies to date have been limited, and access from the dermis to lymphatic
and blood circulation is considered possible or likely. Penetration into the skin especially in the
case of inflammatory or traumatic lesions is very likely as it was even demonstrated for larger
particles.
Oral ingestion of nanoparticles, such as from food packaging and food additive uses, seems likely
but has not been adequately tested to date. Once ingested, some scientific studies report that
nanoparticles are transported from the intestine into the blood stream. For small particles (< 100
nm) increased uptake through the intestinal wall has been observed in rats.
Multiple studies have demonstrated that some nanomaterials are efficiently transported directly
from olfactory neurons into the central nervous system, circumventing the blood-brain barrier.
Data on translocation between organs are based on different approaches, so they cannot yet be
considered to have been confirmed. According to various studies surface-modified nanoparticles
crossed the blood-brain barrier. It has not yet been reported in the public literature whether the
blood-testis barrier or the placental barrier can also be crossed, but it is suspected that these things
are possible, in view of the fact that the particles are in the range of nm.
8.3
Occupational health
Peter Kearns - please add text to describe the work OECD is doing in the area of OSH. Thank
you.
At the workplace, according to our present knowledge, exposure to nanoparticles occurs primarily
through handling nanoparticles that were produced for a specific purpose, and through working
practices that generate nanoparticles as unintended by-products. Although there is not yet an
overview of the types, quantities, or forms of application of nanoparticles, as by-products they are
considered to be the most widespread source of exposure in the workplace.
There have not yet been any epidemiological studies on the health risks of modern manufactured
nanoparticles. Concentrations at the workplace have barely been estimated so far, and it is not
clear whether the current models for local and temporal concentration profiles apply in the case of
new nanoparticles. At present apart from a convention between a few European institutes of
occupational safety there are no international standards on methods for measuring nanoparticles
and for estimating exposure to them. ISO has created a committee on nanotechnology8, in order to
produce norms based on scientific knowledge in the areas of health, safety and the environment.
8
ISO Technical Committee (TC) 229 «Nanotechnologies».
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Until norms in this area become available, exchanges of experience between measuring engineers
and scientists will be particularly important.
The known strategies to reduce exposure in the workplace also apply to dealing with nanoparticles. Appropriate protection measures are evaluated and defined by specialists in
occupational health and safety as part of an assessment of risks throughout the company. In some
countries the principle applies that new substances with unknown properties should be treated as
potentially dangerous. Organisational protection measures should primarily be taken, supported
by technical protection measures and the substitution of preparations that form powders.
Personal protection equipment can occasionally supplement these measures, but it should not
replace them. Current recommendations are firmly based on analogy with handling larger
particles. But it is still highly uncertain how efficient technical protection systems and personal
protection equipment can be, especially for new nanoparticles with a very low tendency to
agglomerate.
Therefore, there is still a lack of the scientific and methodological basis to carry out a robust risk
assessment of nanoparticles. Several large-scale programmes are running or being planned in
Switzerland and at the international level. These will deal with different aspects of risk research
on nanoparticles. In this context, it is critical to have a coordinated, strategic approach to deal
with the most important issues.
8.4
Environment risks
At present, only a few studies have been carried out on the ecotoxicity and environmental
behaviour (fate and transport) of nanomaterials. So far, numerous studies have reported on the
highly toxic impacts of nanoparticles on aquatic organisms. Though many of these studies are
limited because the test material was inadequately characterized.
There are not yet any reliable estimates of possible environmental inputs that could occur during
the production, use and disposal of nanoparticles or products containing nanoparticles. In
particular there is a lack of suitable methods to measure nanoparticles in the environment.
Similarly, scarcely any studies have been carried out on by-products and breakdown products of
nanomaterials. The basic aspects of the behaviour of micrometre-range particles in the air or in
aqueous solutions have been clearly described and they can be understood in terms of quantitative
models. As far as possible, nanoparticles should be introduced into these existing models, or
appropriate new models should be developed. Normally, nanoparticles in gases can be removed
relatively simply by rapid agglomeration to bigger structures by diffusion filtration or depth
filtration. In liquids this may be difficult under certain circumstances if there are stabilized
dispersions. The effectiveness of breakdown in wastewater treatment works has barely been
examined so far. Preliminary investigations show that the present treatment process may not be
sufficient, but the literature is not all in agreement. So far, there are few studies exploring
bioaccumulation and the possibility of the accumulation of nanoparticles in the food-chain.
However, investigations show that nanoparticles can be taken up by organisms in the
environment. We have to consider on one hand the storage of lipophilic nanoparticles in fatty
tissues, and the resultant concentration in the food-chain, and on the other hand the accumulation
of persistent nanoparticles in ecosystems and organisms if there are no pathways for their
breakdown or excretion.
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The specific physical and chemical properties of nanoparticles compared with larger particles can
present unexpected safety risks. The most important physico-chemical dangers are the risks of
fire or explosion and of unexpectedly increased catalytic activity. So far, these dangers have been
classified as relatively low for many manufactured nanoparticles, as nanoparticles are produced in
relatively small quantities. However, this is likely to change rapidly in the future.
In clouds of dust, the size of the particles and the related specific surface area are critical for the
explosion characteristics. Basically, the smaller the particles are, the greater the risk of a dust
explosion will be. However, the physico-chemical properties of many particles are still only
partly understood, so it is difficult to estimate these risks.
8.5
Ethical issues
A 2006 UNESCO publication9 states "... ethical issues in relation to nanotechnology should be
identified and analyzed so that the general public, specialized groups and decision-makers can be
made aware of the implications of the new technology. Since nanotechnology is developing
quickly, an anticipatory approach to ethical issues is necessary." … "From the perspective of
UNESCO, even if nations are not actively pursuing research in nanotechnology, they should
nonetheless have a stake in defining the proposed outcomes and actual course of research
according to norms of equity, justice and fairness. ……. At this early stage, citizens of every
nation have a stake in understanding what nanotechnology is becoming and could be."
The UNESCO publication presents a number of ethical issues that the international community
will face in the near future. The report states that as the use of nanomaterials and nanoscale
production processes is commercialized new ethical and political issues can be generated and old
ones will be activate. It further states that "nanotechnologists are hyper-aware of the need to study
both potential uses and potential harms well in advance of their commercialization. This
recognition and precautionary direction to corporate research is novel." It notes that the
institutional and organizational framework for address the concerns across competing interests
associated with creating and adoptions of standards and international best practices are not yet
well developed.
The report states that the ease of communication and access to information by experts in most
countries would indicate that nanotechnology will be an international scientific project and the
"knowledge divide" between countries may look different from the past with the possibility of the
greatest divide within nations rather than between nations. Relevant to this is the question of how
nanotechnology research that could benefit the poorest should be promoted, for example research
on applications that could address the MDGs.
A related question is the extent to which all nations will benefit equally from the new scientific
knowledge. The report notes the issues of intellectual property rights and rewards, public scrutiny
of scientific research, accountability of research and the use of scientific information in the
context of antiterrorism efforts all may impact the kind and quality of science. The lack of the
necessary infrastructure to manage good science may result in developing countries unable to
obtain the best and most reliable scientific knowledge and practices.
9
The Ethics and Politics of Nanotechnology (UNESCO, 2006)
http://unesdoc.unesco.org/images/0014/001459/145951e.pdf
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Manufactured nanomaterials and the precautionary approach:
Even though there are uncertainties and gaps in our knowledge of possible adverse impacts of
manufactured nanomaterials (cf. 8.2, 8.3, 8.4), we are not in a situation of complete ignorance.
For initial toxicological tests indicate that at least some manufactured nanomaterials may cause
serious harm to humans and the environment.
If this is an adequate description of the current state of knowledge the question arises of how we
should assess the risks of manufactured nanomaterials from an ethical viewpoint and what we
should do with regard to the regulation of these materials. Concerning this question one finds,
roughly speaking, two opposing views in current literature:
1. There are those who argue that, although some indications of the potential risks of some
manufactured nanomaterials for humans and the environment can be recognized, there is
no reason to have serious concerns. In particular there is no reason to assume that these
risks are of a kind that would justify the application of the strong precautionaryapproach,
especially the reversal of burden of proof. That does not mean that the production and
utilization of manufactured nanomaterials for commercial or scientific purposes does not
require any kind of state regulation. For instance, asking producers of nanomaterials and
nano-enabled products containing free manufactured nanoparticles to carefully analyse
the risks associated with these particles or asking them to reduce the exposure in the
workplace as much as possible may be perfectly warranted. (Risk research, i.e. research
to reduce uncertainty, premarket testing, reduction of exposure etc. are all precautionary
measures.) Nevertheless, manufactured nanomaterials may be used in scientific research
as well as in commercial products even if there is some – as yet inconclusive – evidence
that they may not be completely harmless.
2. There are those who claim that for the time being at least the use of free manufactured
nanoparticles in commercial products and the deliberate release of those particles in the
environment should be prohibited. In order to justify this they invoke the strong version of
the precautionary approach. In particular they argue that the risks associated with these
particles warrant a reversal of the burden of proof: It is not the State, but the proponent
(producer) of a hazardous technology – in this case particularly nanotechnologies using
free manufactured nanomaterials – that must prove that it is harmless. This does not
mean that proof of zero risk is required; it is enough to produce solid scientific evidence
that the risks are able to be identified and managed/mitigated effectively,
The main theoretical question in this context is: Which conditions must be met for the adoption of
precautionary measures? More specifically: What kind of empirical evidence regarding the risks
of manufactured nanomaterials justifies what kind of precautionary measure? There seems to be
agreement that some of those materials such as carbon nanotubes and buckyballs do have the
potential to cause considerable harm in humans and the environment. But given the knowledge
gained from in vitro- and in vivo research thus far what kind of regulatory measures are most
suitable? At the moment this is hard to tell. The reason is that it depends on how one interprets
the available scientific data. How do we draw the line between reasonable precaution and
excessive precaution?
Yet there is one point where there is unanimity: Because it is clear that at least some (free)
manufactured nanomaterials are not harmless and because the occurrence of harm must be
avoided as far as possible there is a moral obligation to press ahead with risk research.
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