https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/228785/7620.pdf
UK Government Response to
The Royal Commission on Environmental
Pollution (RCEP) Report
“Novel Materials in the Environment:
The Case Of Nanotechnology”
Presented to Parliament
by Command of Her Majesty
June 2009
Cm 7620 £9.50
UK Government Response to
The Royal Commission on Environmental
Pollution (RCEP) Report
“Novel Materials in the Environment:
The Case Of Nanotechnology”
Presented to Parliament
by Command of Her Majesty
June 2009
Cm 7620 £9.50
© Crown Copyright 2009
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ISBN: 9780101762021
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Contents
CHAPTER 1
INTRODUCTION 5
CHAPTER 2
GOVERNMENT CO-ORDINATION ON NANOTECHNOLOGY 7
CHAPTER 3
PROTECTING HUMAN HEALTH AND THE ENVIRONMENT 10
CHAPTER 4
BUILDING THE EVIDENCE BASE 15
CHAPTER 5
DELIVERING MORE EFFECTIVE REGULATION 19
CHAPTER 6
WIDENING PUBLIC ENGAGEMENT AND CAPTURING THE BENEFITS 23
CHAPTER 7
CONCLUSIONS 25
ANNEX A
UK MINISTERIAL GROUP ON NANOTECHNOLOGIES 26
ANNEX B
NANOTECHNOLOGY RESEARCH COORDINATION GROUP RESEARCH OBJECTIVES 27
ANNEX C
OECD SPONSORSHIP PROGRAMME – LIST OF THE 14 PRIORITY NANOMATERIALS 29
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CHAPTER 1
INTRODUCTION
1. Nanotechnology is the manufacture, manipulation and measurement of materials
with one or more dimensions in the range 1 to 100 nanometres.
2. Many reactions naturally occur at the nano-scale and nanomaterials are not new. For
instance, they are formed during volcanic eruptions and are part of the bubbles in beer.
However, technological advances are now allowing greater manipulation of materials at
this scale, leading to an expansion in the use of this novel technology.
3. There are a growing number of potential future applications – in areas as diverse
as healthcare, energy and construction – which could help improve our quality of life.
Indeed, nanotechnologies have already started to help us respond to the key challenge of
climate change by improving the performance of solar panels, batteries and fuel burning
processes.
4. Whilst this area of innovation is still at a relatively early phase of development,
it is expected to grow and to influence an increasingly diverse array of products and
applications.
5. In its Report, the Royal Commission on Environmental Pollution (RCEP) has looked
at the properties of nanomaterials and the potential pathways by which these materials
could enter and present potential hazards to the environment and people.
6. Whilst the Royal Commission recognised that the Government is doing much to
ensure the responsible development of nanotechnologies, we are in agreement that
more needs to be done. In particular, the Government shares the Royal Commission’s
understanding that there is no evidence of actual harm resulting from the use of
nanotechnologies, but accepts that this is a possibility and that there is a need to develop
our understanding further.
7. To address this, the Government has already established a large programme of
work, ranging from the development of the research base through to the provision of
guidance for those who work with certain nanomaterials.
8. The Royal Commission’s Report has provided a valuable opportunity to review
progress and reflect on wider lessons for the way in which the Government deals with novel
science and technologies. However, many of the Royal Commission’s recommendations
require long-term work and discussion with others to identify the right way forward.
9. Therefore, the Government intends to develop a UK Strategy for nanotechnologies.
This Strategy will build on previous and existing activities and review the UK’s priorities
and strategic direction. The Government will launch an evidence gathering exercise with
stakeholders in the summer to inform its development.
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10. This response addresses each of the Royal Commission’s recommendations,
grouping these around the following five main themes, which reflect the Government’s
key strategic priorities:
i) Government co-ordination on nanotechnology
ii) Protecting human health and the environment
iii) Building the evidence base
iv) Delivering more effective regulation
v) Widening public engagement and capturing the benefits
11. This Command Paper forms the Government’s response to the Royal Commission’s
Report, and has been developed in consultation with the Devolved Administrations.
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CHAPTER 2
GOVERNMENT CO-ORDINATION ON NANOTECHNOLOGY
1. From development and manufacture, through application and disposal, to potential
impacts on human and environmental health – the use of nanotechnologies presents a
number of cross-cutting challenges.
2. In order to meet these, the Government has established a twin-track approach
to facilitate knowledge sharing and take forward action in this area. Firstly, through
structured groups which meet regularly, and secondly, through the use of more dynamic
and informal networks.
The Royal Commission recommended that responsible organisations set up
structured systems to keep a watching brief on the development of novel materials
and to enhance the sharing of information and the opportunities to work together to
identify and manage emerging problems.
The Government agrees with this recommendation and recognises that there
may be a need to adjust existing systems to create a more integrated approach to
nanotechnologies, engaging a wider range of stakeholders to enhance the sharing
and understanding of available information. The Government will consider this during
the development of the UK Strategy on nanotechnologies.
Summary landscape of UK organisations and networks
3. In order to effectively manage the challenges and maximise the opportunities for
the UK presented by nanotechnologies, Government Departments and Agencies work
together in partnership with wider stakeholders.
4. This co-ordination is achieved though a number of groups and the diagram at
Figure 1 summarises how these interact.
5. The over-arching Government body is the Ministerial Group on Nanotechnologies.
It is chaired by Lord Drayson (Minister of State for Science and Innovation) and is the
key body through which the Government develops and takes forward UK policy on
nanotechnologies.
6. This Group has representatives from the Department for Innovation, Universities
and Skills (DIUS); the Department for Business, Enterprise and Regulatory Reform
(BERR); the Department for Environment, Food and Rural Affairs (Defra); the Department
of Health (DH) and the Department for Work and Pensions (DWP). A list of Ministers is
at Annex A.
7. In support of the Ministerial Group is the Nanotechnologies Issues Dialogue Group
(NIDG) comprising of officials from Departments the Devolved Administration and
Agencies with an interest in the nanotechnologies agenda. The NIDG co-ordinates policy
activity to progress the delivery of decisions taken by the Ministerial Group, as well as
other aspects of the Government’s agenda on nanotechnologies.
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Figure 1
I
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N
A
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N
A
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C
E
N
T
R
A
L
B
O
D
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S
K
E
Y
A
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T
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S
REGULATORY
eg EA, TSB, HSE & HPA
WIDER STAKEHOLDERS
eg Consumer
& Industry groups
OECD
EU
OTHER PARTNERSHIPS
eg UK – USA
Ministerial Group on
Nanotechnologies
NRCG
RESEARCH
-Research Councils
eg NRC, ESPRC & NERC
-Universities
-Research Institutions
ACHS – Advisory Committee on Hazardous Substances
EA – Environment Agency
EPSRC – Engineering and Physical Sciences Research
Council
HPA – Health Protection Agency
HSE – Health and Safety Executive
KTN – Knowledge Transfer Networks
MRC – Medical Research Council
NERC – Natural Environment Research Council
NIDG – Nanotechnologies Issues Dialogue Group
NRCG – Nanotechnology Research Coordination Group
NSF – Nanotechnologies Stakeholder Forum
OECD – Organisation for Economic Co-operation and
Development
RCEP – Royal Commission on Environmental Pollution
TSB – Technology Strategy Board
SCRUTINY AND
ADVISORY ROLES
House of Lords
RCEP
ACHS
Government Departments
NIDG
NSF
8. In wider support, the Government’s Nanotechnology Research Co-ordination Group
(NRCG) brings together Departments, Agencies, Research Councils and Devolved
Administrations to steer the Government’s research programme.
9. In order to benefit from further scientific expertise, Departments can consult
specialist advisory committees. These include the UK’s Advisory Committee on Hazardous
Substances (ACHS), which has a broad membership including experts from the fields of
medicine, chemistry and ecotoxicology, and the Committee on Toxicity of Chemicals in
Food, Consumer Products and the Environment.
10. The Research Councils and the Technology Strategy Board also have an invaluable
role as funders of research and contributors to capacity building of techniques, scientists
and research centres in the UK. Involvement of the Research Councils in the NIDG and
NRCG is co-ordinated through the RCUK Nanotechnology Group.
11. The Government has also established the Nanotechnologies Stakeholder Forum
(NSF) which provides a valuable means of information exchange on developments in
nanotechnologies between the Government and a wide range of stakeholders, such as
industry and consumer groups.
12. It is through the ongoing development of this extensive network that Government
maintains a pro-active approach to building and sharing evidence, and developing the
science and opportunities that underpin nanotechnologies. However, the Government
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recognises that there is scope for improvement and will consult on this issue as part of
the development of the UK Strategy for nanotechnologies.
Adaptive management
13. The Royal Commission also highlighted the principle of adaptive management. The
Government recognises the importance of systems through which information can be
channelled, so that there is a timely reaction to new challenges. Clear communication
between the Government and its stakeholders is key if the assessment and management
of potential risks is to be carried out effectively, and the benefits realised.
14. In order to facilitate this communication a number of networking initiatives have
been established, including:
• part of the Micro-Nano Facilities Network funded jointly The Safenano Initiative:
by the Technology Strategy Board, Devolved Administrations and industry.
Safenano is run by the Institute of Occupational Medicine and provides
independent, impartial advice concerning the potential risks to human health
and the environment from nanomaterials.
• the Technology Strategy Nanotechnology Knowledge Transfer Network:
Board has established this three-year £2.5m project, to facilitate the transfer
of knowledge and experience between researchers and industry. This is vital
in bringing together technology providers and end users across a number of
important market sectors.
• provides an independent, EU-wide, human and environmental AssuredNano Ltd:
health accreditation scheme for organisations producing nanomaterials and
nano-enabled products, which promotes the application of good practice.
15. These initiatives provide fora within which new information can be disseminated
and shared on an ongoing basis but, as the Royal Commission notes, more needs to be
done to improve the sharing of information about new developments and potential risks.
16. The Government will consider further how these and other mechanisms might be
used to complement the more formal Government-led networks described above.
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CHAPTER 3
PROTECTING HUMAN HEALTH AND THE ENVIRONMENT
1. The Government shares the understanding with the Royal Commission that
no evidence exists of actual harm caused by nanomaterials, but accepts this is a
possibility.
2. The protection of human and environmental health has always been – and remains
– a clear priority for Government and much has already been done to progress the
understanding and management of potential risks.
The Royal Commission recommended the establishment of clear priorities for testing,
beginning with those nanoparticles with functionality which suggests that they might
pose the greatest risk of harm to the environment or human health.
The Government recognises the need to prioritise research into nanomaterials which
pose a higher potential risk, in particular those which are currently available or close
to the market, and has already progressed much work in line with this principle.
The Royal Commission recommended that environmental monitoring to detect
manufactured nanoparticles should be the responsibility of the Environment Agency
in England and Wales, the Scottish Environment Protection Agency and the Northern
Ireland Environment Agency, to ensure that robust processes are used.
The Government agrees that the monitoring of manmade nanomaterials is important
and, where a specific risk has been identified, responsibility for the monitoring of
manmade nanomaterials in the environment should fall to the relevant agency.
However, the specific tools and techniques required are not currently available and
the Government has commenced work to develop these.
3. This section contains text boxes summarising steps already taken in relation to the
three nanomaterials noted in particular by the Royal Commission: nanosilver, carbon
nanotubes and Buckminsterfullerenes.
Protection of human health
4. Exposure to nanomaterials is not new and many natural processes take place at the
nanoscale. However, recent advances have resulted in the development of new products
containing these manufactured nanomaterials. For example, nanosilver is sometimes
used in cleaning products to improve their effectiveness.
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Nanosilver
Nanosilver is well known to have antimicrobial properties. The Woodrow
Wilson Centre’s inventory of nano-products states that there are currently
235 products using nanosilver commercially available throughout the
world.
Whilst this includes all types of products, there is currently only limited
marketing in the UK. For example, a small number of colloidal silver
food supplements and cleaning products.
However given the potential for use of nanosilver in products such as
clothing, cosmetics and wound dressings, the Government has asked
the UK’s Advisory Committee on Hazardous Substances (ACHS) to
consider the research undertaken to date and advise on how the use of
this material may be best managed.
5. It is important that as the use of these products increases we act to build our
understanding and have in place regimes to protect human health and the environment.
6. There is already much legislation in place to deal with potential risks. Whilst the
legislation is not ‘nano-specific’ it places an emphasis on the need for products to be
safe. For example:
• The Biocidal Products Directive requires rigorous evaluation of both the active
substance(s) and the biocidal products containing them, before they are placed
on the market.
• The Cosmetic Products (Safety) Regulations prohibit the supply of a cosmetic
product liable to cause damage to human health under normal or reasonably
foreseeable conditions of use.
• For human medicines the manufacture, sale, supply and importation of medicinal
products into the UK is governed by Directive 2001/83/EC as amended by
Directives 2003/63/EC and 2004/27/EC. All medicines on the UK market have
been considered to be acceptably efficacious and safe.
• On food products, dating from the 1800s, the UK has only permitted safe food
products to be placed onto the market. This is now applied through the EU’s
General Food Law Regulation. In addition, the EU Novel Foods Regulation
requires specific safety testing and authorisation before novel food products,
such as those containing new manufactured nanoparticles, can be placed on
the market.
• More widely, the Product Safety Directive places a duty on suppliers of consumer
goods to supply only products that are safe in normal or reasonable use.
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7. The Government recognises the need to further increase the understanding about the
potential effects of nanomaterials in order to inform decisions about what, if any, further action
is needed.
8. A great deal of this work is ongoing, including:
• The Department of Health is providing £1.25m of research into the issue of
nanotoxicology, with four research projects totalling £600k having recently been
funded by the Department.
• Since 2007, the Medical Research Council (MRC) has awarded £3m of research
grants into nanotoxicology research.
• The Health Protection Agency (HPA) has established the National Nanotoxicology
Research Centre (NNRC). Work at the Centre will commence in late 2009, focusing
on the biokinetics of nanomaterials – their uptake via inhalation and dermal routes,
and their transport and distribution within, and removal from, the body.
Carbon Nanotubes
In 2004 the Royal Society and Royal Academy of Engineering reported
that carbon nanotubes (CNTs) warranted particular attention due to
their physical characteristics being similar to those of asbestos.
Following this, the Health and Safety Executive (HSE) published
guidance in June that year on management issues related to
nanomaterials advising that a risk assessment should be the first
step in ensuring effective control within the workplace.
In 2008 the University of Edinburgh published research showing that
certain forms of CNTs could produce similar reactions to some types
of asbestos fibres when injected into the abdominal cavity of mice.
While this research does not prove that CNTs will cause the same
effects as asbestos, it does prove that one step in the causal chain for
mesothelioma is the same.
Subsequently, Defra sought advice from Cambridge University on the
use of CNTs in consumer products. This work suggested that current
uses and applications of CNTs were unlikely to present a serious risk
to the public, but that further study was needed. As a result a CNT life
cycle exposure study has now been commissioned by Defra which is
due to report in summer 2009.
In addition, the HSE issued specific guidance in spring 2009 on the safe
use and handling of carbon nanotubes, recommending that in the use
of CNT’s a high level of control should be exercised.
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Environmental protection
9. As noted earlier, nanomaterials are not new and many processes within the
environment naturally take place at the nanoscale. However, protection of the environment
from potential impacts of nanomaterials is a key strand of the Government’s approach.
10. Again, legislation is already in place to do this, including:
• The EU REACH Regulation which requires chemicals identified as being of high
concern to be authorised for particular uses before they can be marketed. Reviews
can also be undertaken if there is new evidence to suggest that they may cause
harm to human or environmental health.
• The Plant Protection Products Regulations 2005 provides powers for garden
pesticides to be the subject of restriction and prohibition if evidence of harm to
human health or the environment emerges.
• The Hazardous Waste Regulations requires waste containing nanomaterials
to be disposed of in limited, specified ways should it pose a risk to human or
environmental health, with those responsible being required to register with the
relevant environmental regulator.
11. However, further understanding of the environmental pathways of nanomaterials and
potential areas for accumulation in ecosystems is necessary. In this context, the UK has
embarked on a substantial research programme to significantly increase our knowledge
base, in particular through the Environmental Nanoscience Initiative (ENI).
12. The ENI was set up by the Natural Environment Research Council (NERC), Defra
and the Environment Agency to begin to answer questions about the fate, behaviour,
ecotoxicology and ecological effects of engineered nanoparticles.
13. In phase 1, launched in 2006 and ending earlier this year, 17 small-scale research
projects were funded covering multiple areas including ecotoxicology in freshwater and
marine model systems. These projects highlighted the need for existing test guidelines to
be reviewed and this is now being taken forward with the OECD.
14. The UK and USA have now launched Phase 2 of the ENI (ENI-2). This joint programme
will build on the achievements of Phase I, and draw on complementary strengths in the UK
and USA to produce robust, validated models that predict transport, fate and bioavailability
of nanomaterials and their interaction with biological and ecological systems.
15. The purpose of this £6m+ international collaborative research programme is to
strengthen the support for research on the potential implications of nanotechnology and
engineered nanomaterials on human health and the environment.
16. By maximising complementary and interdisciplinary strengths, the outputs of this
collaborative endeavour should not only be a comprehensive understanding of key classes
of nanomaterials, but also the development of predictive tools for exposure, bioavailability
and effects. This will in turn support more confident statements concerning their effects and
appropriate responses to mitigate potential risk.
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Buckminsterfullerenes (C60)
The use of Buckminsterfullerenes in the UK is very limited. As a result
this nanomaterial does not form a primary focus of our work, but does
form part of the OECD-level programme on characterisation in which
the UK is a full partner.
This provides a good example of how, by working collaboratively,
countries can progress research into these materials much more quickly
than by individual countries working alone.
We outline the work of the OECD Working Party on Manufactured
Nanomaterials in more detail in Chapter 4.
Monitoring
17. Specific to the issues raised by the Royal Commission on monitoring nanomaterials
in the environment, the Government is already undertaking an extensive programme of
work to enhance our measurement capabilities.
18. A substantial programme of work on nanoparticle measurement and characterisation
was established under the DIUS-led National Measurement System (DIUS NMS) shortly
after the 2004 publication of the Royal Society and Royal Academy of Engineering
report.
19. This work has been designed to address the current and future measurement and
characterisation requirements for toxicologists, eco-toxicologists and environmental
scientists both in the laboratory and in the field. Around £5m has been committed
specifically to addressing fundamental metrology for nanoparticles.
20. A key early success was the establishment at the National Physical Laboratory
(NPL) of a facility focused on the detection and measurement of airborne nanoparticles.
This has led to the launch of the world’s first accredited and traceable calibration service
for airborne nanoparticle number concentration. Current research is focused in a number
of areas including detection of engineered nanoparticles against ambient background
levels and on measurement of key characteristics of airborne nanoparticles such as size
and surface area.
21. In addition, work supported by DIUS, Defra, the Technology Strategy Board and the
Engineering and Physical Sciences Research Council (EPSRC) is currently developing
new technologies to allow the detection of manufactured nanomaterials in the wider
environment. As a result of the ENI programme, the NERC has identified this as a key
need and has recently established a Facility for Environmental Nanoparticle Analysis and
Characterisation.
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CHAPTER 4
BUILDING THE EVIDENCE BASE
1. The Government believes that a co-ordinated and targeted research programme
is vital if research needs are to be met and the appropriate scientific skills base is to be
developed.
2. It is widely recognised that materials on the nanoscale frequently exhibit different
properties and functionalities from their bulk forms. These differences form much of the
focus for research in this area, but it is also necessary to understand their behaviour in
the wider environment so consideration can be given to which organisms, if any, are at
risk of exposure.
The Royal Commission strongly recommended a more directed, more co-ordinated
and larger response led by the Research Councils to address the critical research
needs raised by their report, with emphasis on regulatory and policy programmes.
The Government believes that the Nanotechnology Research Co-ordination Group –
in which the Research Councils play a key and active role – is best placed to achieve
this. However, the NRCG is currently undertaking a review of its research priorities
and we will consider the options for a centrally managed approach as part of this.
The Royal Commission recommended that urgent attention is given to undergraduate
and postgraduate training in toxicology across all of its domains and that DIUS, the
university sector and the professional societies that represent medical toxicologists
and ecotoxicologists establish new initiatives to build multidisciplinary capacity in
this field.
The Government recognises this needs to be addressed and has commissioned a
study to determine the scale of the issue and identify how it might be tackled. Once
that study reports, DIUS, DH, BERR, Defra and the MRC will lead the necessary
actions to implement the recommendations.
3. In order to gain a better understanding of nanomaterials a multi-million pound multidisciplinary
research programme has been established, spanning domestic, European
and wider international partners.
At the UK level
4. In their 2004 report “Nanoscience and Nanotechnologies: Opportunities and
Uncertainties”, the Royal Society and the Royal Academy of Engineering recommended
that immediate research be commissioned to address uncertainties about the nature,
behaviour and health and environmental effects of nanomaterials.
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5. The Government responded by establishing the Nanotechnology Research Coordination
Group (NRCG) in 2005 whose role is to co-ordinate research in the UK into
nanotechnologies. The group adopted 19 Research Objectives (listed at Annex B) which
have been taken forward by five Task Forces:
TF1 – Metrology, characterisation and standardisation
TF2 – Exposure sources, pathways and technologies
TF3 – Human health hazard and risk assessment
TF4 – Environmental hazard and risk assessment
TF5 – Social and economic dimensions
6. More recently, in recognition of the potential need to prioritise specific areas the
NRCG commissioned the ‘EMERGNANO’1
project, which reviewed 650 research projects
undertaken since 2004 both in the UK and overseas.
7. One of the aims of that project was to identify specific areas where research
may need to be focused in order to more fully develop understanding of manufactured
nanomaterials.
8. The NRCG is now considering the results of this report in the context of the wider
review of its research objectives, which it expects to conclude later this year.
At the European level
9. The European Commission is a significant funder of nanotechnologies research.
Since 2004 nano research has been taken forward through the Sixth and Seventh
Framework Programmes (FP6 and FP7). The total value of FP7 (which will run from 2007
to 2013) is 53.2 billion Euros, of which the UK expects to receive approximately 100m
Euros for nanotechnologies-related research.
10. By their nature, Framework Programmes are multidisciplinary and co-operative and
so it is difficult to identify exact total expenditure on nanotechnologies. However, this
multi-million pound initiative provides a valuable stimulus for such research. For example,
FP7 funds UK Nanoretox which is a two year project worth around £4.4m to examine the
reactivity and toxicity of nanoparticles and the risk they pose to human health.
11. The UK is in a strong position to influence work within the EU as it has developed
leading roles in a number of projects, as well as strong industrial, academic and
governmental links to European nanotechnology policy makers.
1
http://randd.defra.gov.uk/Default.aspx?Menu=Menu&Module=More&Location=None&ProjectID=16006
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At the international level
12. The challenges posed by nanotechnologies mean that far more can be achieved
through collaboration at the international level. For this reason, the UK Government has
been among the leaders in the international effort to promote dialogue and facilitate the
exchange of information.
13. The Organisation for Economic Co-operation and Development (OECD) provides
an overarching structure for sharing information on nanotechnologies through two groups,
the Working Party on Manufactured Nanomaterials (WPMN) and the Working Party on
Nanotechnology (WPN)2
.
14. The Working Party on Manufactured Nanomaterials (WPMN), established in
London in June 2006, aims to promote international co-operation in human health and
environmental safety related aspects of manufactured nanomaterials. The UK has a key
role in this group as a member of the steering Bureau.
15. The work of the WPMN includes a £30-40m research programme to develop
understanding of the functionalities of fourteen of the most widely used nanomaterials
(listed at Annex C), as well as developing nano-specific testing methods.
16. The UK is the lead sponsor of two of these fourteen nanomaterials (cerium oxide
and zinc oxide), taken forward through the £3.7m PROSPEcT project which brings
together the Engineering and Physical Sciences Research Council (EPSRC), Defra, the
Technology Strategy Board and UK industry as joint sponsors. The project aims to build
understanding of the characteristics of these nanomaterials and their likely ecological
impact.
17. These international links allow the research effort to be shared between countries,
enabling co-ordinated progress to be made, whilst making the best use of resources and
avoiding unnecessary duplication. Through such an approach the Government seeks
to optimise the use of available expertise and evidence to respond to critical research
needs and inform policy makers.
Developing the skills base
18. The Royal Commission also made specific note of the need to build capacity in
nanotechnology research. Progress has been made towards promoting training in this
field, but the Government recognises that more needs to be done.
19. Defra has already commissioned an evaluation of the current toxicology and
ecotoxicology skills base in the UK and this study, which is due to report in the summer of
2009, will provide an estimate of the requirement for toxicologists and ecotoxicologists.
20. The report will also recommend measures to address issues affecting retention and
recruitment in this area. It will provide the evidence base to allow DIUS, DH, BERR and
Defra to engage in a productive dialogue with, and provide a policy steer to, the Sector
2
www.oecd.org/sti/nano
18
Skills Councils and National Skills Academies, and also enable the Research Councils to
identify where further action may be needed.
21. The Research Councils have a crucial role in developing the skills base. For
example, in 2007 the Medical Research Council (MRC) posted a policy highlight notice
for nanotoxicology to encourage innovative, high quality research applications. This has
already drawn considerable interest and resulted in funding commitments of approximately
£3m.
22. Training awards in nanotoxicology are further supported through the Integrative
Toxicology Training Partnership (ITTP), which is managed by the MRC Toxicology Unit in
Leicester. This aims to produce a further 20 toxicologists.
23. More broadly, to enable the UK to make an international impact, a new mission
programme of the Research Councils UK (RCUK) was formed in 2006 called
‘Nanoscience through Engineering to Application’. This programme will develop a series
of interdisciplinary Grand Challenges in areas that are important to society and where UK
nanotechnology research can make a significant contribution – for instance healthcare,
energy and the environment.
24. This approach is led by the EPSRC and has already resulted in a commitment of
research funding for 2008/09 of £19m, with a further £30m planned for future support
of the Grand Challenges. In addition, the programme has also established a network of
existing nanotechnology and nanofabrication facilities that can be shared by researchers
and funds 40 research students per year through a number of doctoral training centres.
25. The Government will continue to press forward with progress in this area to ensure
that the UK skills base is developed. The NRCG has been asked to consider its role in
promoting this as part of their review of priorities.
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CHAPTER 5
DELIVERING MORE EFFECTIVE REGULATION
1. Legislation plays an important role in managing the risks of any new area of
technology. The Royal Commission made a number of recommendations in the area of
regulation and in this section we address each in turn.
Revisions to existing legislation
The Royal Commission recommended that:
• in any revisions to existing regulations, the relevant authorities should focus
specifically on the properties and functionalities of nanomaterials, rather
than size;
• as REACH is adapted to meet the challenges presented by nanomaterials,
particular attention should be given to the issue of weight thresholds. In view
of the persistent uncertainties involved, a precautionary approach should be
adopted when determining new, lower thresholds for nanomaterials.
• the UK Government should press the European Commission to proceed
with urgency, in consultation with Member States, the European Chemicals
Agency and SCENIHR3
, to review REACH and product or sector specific
regulations. The object of the review should be to amend the regulations
to facilitate their effective application to nanomaterials and the provision of
adequate testing arrangements.
2. The Government agrees with the Royal Commission that the REACH Regulation
provides the most sensible legislative framework for the regulation of nanomaterials, in
tandem with more specific legislation where this exists (for example on biocidal products).
Likewise, the Government recognises that functionality, rather than size, should be the
focus of any revisions to REACH, and that weight thresholds must be given particular
attention.
3. REACH is based on the principle that manufacturers, importers and downstream
users have to ensure that their substances may be safely handled and used, thus
improving protection of human health and the environment. Currently, nanomaterials
produced or imported in amounts greater than one tonne per year will be covered by
REACH, as will any nanomaterials which are produced or imported alongside bulk forms
of the substance so that together they meet the registration threshold.
4. In addition, should a nanomaterial be of concern, the European regulatory
authorities can undertake work to identify whether use of that material may need specific
3
Scientific Committee on Emerging and Newly Identified Health Risks
20
authorisation. Equally, restrictions can be placed on the use of nanomaterials if they are
shown to be hazardous.
5. The Government agrees that some changes may be necessary to the current
framework to more effectively manage the use of nanomaterials. In particular, the
Government recognises the limitations of the annual one tonne threshold for registration
and that the test guidelines may need to be extended to cover risks specific to
nanoparticles.
6. In order to address this, the UK is engaged at the European level in a Nanomaterials
and REACH Sub-Group. This brings together Member State representatives with
knowledge of both REACH and nanomaterials issues to consider thresholds as well as
other issues relating to their definition and evaluation.
7. This Sub-Group is due to conclude its work in 2012 and, in light of its advice,
the European Commission is expected to propose suitable changes to REACH. The
Government shares the Royal Commission’s opinion that this review, along with the review
of other sector-specific regulations, needs to be rapidly progressed. Defra’s Secretary of
State has already written to the European Commission urging an ambitious timetable for
completion of this work.
8. The UK also keeps sectoral legislation under review and, where necessary, seeks
to revise this on a case by case basis at the EU level. For example, an EU Cosmetics
Regulation, directly applicable in Member States, has recently been drafted to take into
account nanomaterials. A revision of the EU Novel Foods Regulation has also begun.
Additional legislation
The Royal Commission recommended that the Government impose an additional
legal duty on companies to report at the earliest opportunity to the competent
authorities any reasonable suspicion that a material presents a risk to people or the
environment. Compliance with this requirement should offer duty holders a degree of
immunity from criminal liability, should problems associated with the nanomaterials
arise in future.
9. The Government agrees with the Royal Commission that it would be very useful to
have early access to information that researchers and companies obtain about the possible
implications of new materials and products. However, having carefully considered this
recommendation, the Government does not consider that a new legislative requirement
is an appropriate way forward.
10. Instead, Government will explore alternative ways of obtaining early information
about new materials and products through existing structures and stakeholder networks,
and will keep this ‘horizon scanning’ function in mind during the forthcoming development
of the UK’s Strategy for nanotechnologies.
21
11. On the issue of immunity for duty holders, the Government has outlined above that
specific legislation exists requiring companies to act in a way that protects human and
environmental health. Complying with these statutory obligations does not confer any
immunity on an operator who reports a potential risk, although it may offer a potential
defence. For example, the UK’s implementation of food law includes the principle of ‘due
diligence’ as a possible defence when a food operator is being prosecuted, but not de
facto immunity from prosecution.
12. Ultimately, the decision whether to prosecute would be for the relevant enforcement
authorities, taking account (inter alia) the scale of the offence, the circumstances in which
it occurred and the likelihood of gaining a conviction. If taken forward, it is then a matter
for the judiciary to consider the arguments of the defence and prosecution in reaching a
decision.
Information exchange with industry
The Royal Commission recommended that:
• the idea of a simple checklist, as part of an early warning system be
developed and defined further by the Government to investigate the potential
for development amongst the wider materials community.
• Defra should make nanomaterials reporting mandatory.
13. In 2006 Defra launched a Voluntary Reporting Scheme for manufactured
nanomaterials. This had the twin aims of increasing our understanding of nanomaterial
use in the UK and developing our knowledge of the properties and characteristics of
engineered nanoscale materials by requesting scientific data. 13 responses were
submitted.
14. However, given the increasing interest in this area the Government agrees that
additional work to boost our understanding is required.
15. The Government believes that a revised version of the earlier reporting scheme will
address the ‘simple checklist’ approach suggested by the Royal Commission, and assist
greater partnership working to develop our understanding of the science. This could
include details of manufacturers and importers, information on quantities produced and
how they are used in wider industry.
16. In doing this, it will also be important to keep in view the requirements of the REACH
Regulation. Our initiative should ideally assist the nanomaterials industries in ‘building
a bridge’ to a future REACH nanomaterials regime (which may well include a reporting
requirement), rather than creating additional burdens.
22
17. The Government has not yet reached a final view on the scheme’s design and work
is currently ongoing to define in more detail how this could effectively be introduced.
However, if a revised voluntary scheme is initially preferred and industry does not respond,
the Government would re-assess its consideration of a mandatory scheme.
18. The Government will also review its existing structures and mechanisms for sharing
information and for stakeholder engagement, with a view to finding ‘light touch’ ways
of encouraging researchers and companies to provide early evidence of developments
without compromising their commercial advantage.
23
CHAPTER 6
WIDENING PUBLIC ENGAGEMENT AND CAPTURING THE BENEFITS
1. It is clear that nanotechnologies offer potentially significant benefits, not only to the
economy but also to human and environmental health. It will be important to maximise
these opportunities.
2. Whilst the Government has a role in effectively managing and increasing our
understanding of nanomaterials, there is also a need to promote UK industry’s safe
development of this technology and engage in a two-way debate with the wider public
which responds to their concerns and aspirations.
The Royal Commission recommended it is desirable to move beyond one-off public
engagement ‘projects’ to recognise the importance of continual ‘social intelligence’
gathering and the provision of ongoing opportunities for public and expert reflection
and debate.
The Government agrees that public engagement activities should move towards a
more continual dialogue and is taking steps to ensure this.
Engaging the public
3. During 2008, DIUS undertook a UK-wide consultation on Science and Society.
Public engagement emerged as a key theme and five Expert Groups are now being
established to develop an action plan to help address barriers to effective engagement.
4. The Government has also established the Sciencewise Expert Resource Centre
for Public Dialogue on Science and Innovation as a principal mechanism to encourage
and support public involvement in policy-making. The Centre is now exploring how a
more continuous method of social intelligence gathering could be most effectively
implemented.
5. Complementing this work at the international level, the UK led a project within the
OECD’s Working Party on Nanotechnology. This project undertook a review of member
countries’ activities in public engagement in nanotechnology and developed a set of
guidelines. These are being trialled by member countries during 2009, including the UK,
prior to their publication.
6. In addition, the Government has now commissioned a pilot initiative, to provide
public access to a balanced source of information on nanotechnologies, including
research, products and regulation.
7. This pilot will test the type and level of information that should be provided and
trial a method, based around an interactive website, of both providing information and
enabling public interaction and debate around nanotechnologies as they develop.
24
Engaging industry
8. The Government believes that it is important for industry to capture the economic
potential of emerging technologies, and is supporting this through a number of initiatives
designed to promote the responsible development of nanotechnology.
9. Through the Technology Strategy Board, the Government funds activities to translate
knowledge and ideas generated by research into new products and services to capture
market opportunities where UK academic and industrial capability exists.
10. The Technology Strategy Board operates across all important sectors of the
UK economy, in partnership with many others, including Government Departments,
Research Councils, Regional Development Agencies and the Devolved Administrations.
The Technology Strategy Board has led on key initiatives, including:
• The Nanotechnology Knowledge Transfer Network (KTN)4
- a three year, £2.5m
project to promote responsible development and offering companies access to
information on new processes, patents and funding, as well as keeping them
up-to-date with industry regulation.
• Management of the Small Business Research Initiative (SBRI)5
- a procurement
programme whereby Government Departments buy research and development
services, helping to bring new technologies to market and leading to the
possibility that Government can act as a ‘lead market’ for new and innovative
technologies.
• Collaborative R&D - in Autumn 2007 the Technology Strategy Board launched
‘Materials for Energy’. The focus of this competition was on materials for energy
generation, transmission, distribution, storage and conversion. Of the resulting 16
projects that were funded, 12 of these incorporated some level of nanomaterials
activity.
11. However, the Government also sees industry as having a key role to play in
the responsible development of nanotechnologies. For example, the Technology
Strategy Board’s policy on nanotechnology requires that project proposals involving
manufactured nanomaterials are required to consider any potential risk to people and
the environment.
12. In addition, to scope current industry efforts the NRCG is taking forward research to
examine the nature and extent of Corporate Social Responsibility initiatives practised by
the UK nanotechnologies industries. This work is due to complete in summer 2009 and,
depending on the findings of this research, the Government will examine whether more
needs to be done by industry and ways in which this can be achieved.
4
www.ktnetworks.co.uk/
5
http://www.innovateuk.org/deliveringinnovation/smallbusinessresearchinitiative/whatissbri.ashx
25
CHAPTER 7
CONCLUSIONS
1. The Government’s over-arching aim for nanotechnologies is to realise the potentially
significant benefits to human and environmental health as well as the wider economy, but
in a way that appropriately controls potential risks.
2. The Government will develop an approach that has the protection of human
and environmental health at the heart of its agenda through implementing sound
management practices based on evidence to allow us to act effectively, both specifically
e.g. workplace guidance, and more widely e.g. at the legislative level. Contributing to this
will be the need to realise the potential human and environmental health benefits offered
by nanotechnologies.
3. The Government will continue to ensure an integrated and co-ordinated
approach to nanotechnology through bringing together a wide range of stakeholders,
with a focus on understanding and managing potential risks and ensuring the responsible
development of nanotechnologies.
4. The Ministerial Group on Nanotechnologies will continue to provide the strategic
lead in this area, with input from relevant groups including the Nanotechnology
Research Co-ordination Group and the Nanotechnologies Stakeholder Forum.
5. is important so that our The continued development of the evidence base
understanding of the risks and benefits is increased, and decisions can be made on the
basis of sound evidence.
6. The Government will continue to support the research programme at both
the domestic and international level, and looks forward to the completion of the
Nanotechnology Research Co-ordination Group’s review of its priorities.
7. And where this will prove effective, the Government will continue to work
collaboratively with international partners to deliver more effective management
by assessing the effectiveness of regulatory regimes such as REACH, and considering
how best to adapt these to nanotechnology.
8. Importantly, the Government intends to widen public engagement to ensure that
both the case for nanotechnology and the potential risks and uncertainties are discussed,
as well as helping industry to capture the benefits in order that the UK realises the
human health, environmental and economic gains that nanotechnology can potentially
offer.
9. In order to realise these commitments, the Government intends to launch an
evidence gathering exercise with stakeholders in the summer to inform the development
of a UK Strategy for nanotechnologies
26
ANNEX A
UK MINISTERIAL GROUP ON NANOTECHNOLOGIES
Lord Drayson
Minister of State for Science and Innovation and Chair of Ministerial Group
Department for Innovation, Universities and Skills
Huw Irranca Davies MP
Minister for the Environment
Department for Environment, Food and Rural Affairs
Dawn Primarolo MP
Minister of State for Public Health
Department of Health
Lord McKenzie
Minister with responsibility for Health and Safety
Department for Work and Pensions
Ian Pearson MP
Parliamentary Under-Secretary of State for Business and Competitiveness
Department for Business, Enterprise and Regulatory Reform
27
ANNEX B
NRCG RESEARCH OBJECTIVES
RO1 To understand the social and ethical implications of nanotechnologies through a
programme of public dialogue and social research
RO 2 To identify the most suitable metrics and associated methods for the measurement
and characterisation of nanoparticles.
RO 3 To develop standardised, well-characterised reference nanoparticles.
RO 4 To understand the properties of nanoparticles in the context of their ignition and
explosion potential, and assess/develop methods for evaluating this.
RO 5 Further identification of sources of nanoparticles.
RO 6 Optimisation and development of technologies that enable the measurement of
occupational and environmental exposure to nanoparticles via air.
RO 7 Understanding the fate and behaviour of nanoparticles in air.
RO 8 Development of exposure control devices.
RO 9 Optimisation, development and application of technologies that enable the
measurement of exposure to nanoparticles in soil and water.
RO 10 Research to understand the environmental fate, behaviour and interaction of
nanoparticles in soils and water.
RO 11 Research to establish a clear understanding of the adsorption of nanoparticles
via the lung, skin and gut and their distribution in the body (i.e. toxicokinetics), identifying
potential target organs/tissues for toxicity assessment.
RO 12 Research to establish a clear understanding of inter and intracellular transport
and localisation of nanoparticles and their cellular toxicity.
RO 13 To establish a clear understanding of whether oxidative stress, inflammatory
effects and genotoxicity apply to nanoparticles.
RO 14 Research to establish a clear understanding of the deposition, distribution,
toxicity, pathogenicity and translocation potential and pathways for nanoparticles in the
airways and lung and their potential impacts on the cardiovascular system and brain.
RO 15 Given the current use of nanoparticles in consumer products there is a need to
further our understanding of dermal uptake, penetration and toxicity in the skin.
28
RO 16 To develop testing strategies for human health hazard assessment and assess
how fit for purpose current test methods are as applied to nanoparticles.
RO 17 Research to establish the uptake, toxicity and effects of nanoparticles on
groundwater and soil microorganisms, animals and plants, especially in the context of
remediation.
RO 18 Research to establish the mechanisms of toxicity, toxicokinetics and in vivo
effects of nanoparticles to key ecological groups (including invertebrates, vertebrates
(e.g. fish) and plants). A key aspect of such work should be the facilitating of knowledge
transfer from human toxicological studies to inform ecotoxicology.
RO 19 Define endpoints to be measured in ecotoxicological studies and assess how fit
for purpose current standard tests for persistence, bioaccumulation and toxicity (PBT) are
when considering nanoparticles. This should lead to the defining of a suite of standard
PBT protocols for use in environmental hazard assessment.
29
ANNEX C
OECD SPONSORSHIP PROGRAMME – LIST OF THE 14 PRIORITY
NANOMATERIALS
Sponsorship material Lead sponsor Co-sponsor Contributors
Cerium oxide UK, USA, BIAC Australia,
Netherlands
Germany,
Switzerland, EC
Zinc oxide UK, BIAC USA, BIAC Australia,
Canada
Fullerenes (C60) Japan, USA Denmark, China
Single walled carbon
nanotubes (SWCNTs)
Japan, USA Canada,
France,
Germany, EC,
China, BIAC
Multi-walled carbon
nanotubes (MWCNTs)
Japan, USA Korea, BIAC Canada,
Germany,
France, EC,
China, BIAC
Silver nanoparticles Korea, USA Australia,
Canada,
Germany,
Nordic Council
of Ministers
France, EC,
China
Iron nanoparticles China, BIAC Canada, USA,
Nordic Council
of Ministers
Carbon black Denmark,
Germany, USA
Titanium dioxide France,
Germany
Austria,
Canada, Korea,
Spain, USA,
BIAC
Denmark, China
Aluminium oxide Germany, USA
Silicon dioxide France, EC Belgium, Korea,
BIAC
Denmark
Polystyrene Korea
Dendrimers Spain USA
Nanoclays Denmark, USA
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