Chapter 7 - Nanotechnology
7.1
With scientists now able to manipulate atoms one at a
time, new atomic structures are available. These new structures sometimes have
unique and novel properties, far removed from those of the material at normal
scale. The control of individual atoms and molecules is known as nanotechnology.
The technology is already being used in some sectors of industry: in
manufacturing ultra-fine powders are used for electronics and metal composites and
corrosion and wear resistant coatings. Consumer goods incorporating nanoparticles
are now also available including sunscreens and cosmetics.
7.2
Many consider that the further development of nanotechnology
and nanoscience will have enormous potential in research and industrial
applications with some suggesting that nanotechnology has the potential to
change lives as much as the discovery of electricity or the microchip. The
Prime Minister's Science, Engineering and Innovation Council (PMSEIC) Working
Group on Nanotechnology stated:
[Nanotechnology] could give rise to a whole new set of
industries as well as transform current technologies in manufacturing,
healthcare, electronics and communications.[268]
7.3
Investment in nanotechnology is expanding rapidly and
has more than quadrupled between 2001 and 2005.[269] Given its potential application to
many fields, nanotechnology will have significant economic, environmental and
social implications and will create new challenges for safety and regulatory
regimes.
Nanoscience and nanotechnology
7.4
Nanoparticles are ultrafine particles with aerodynamic
diameters less than 100 nanometres. A nanometre (nm) is one billionth of a
metre. For comparison, a single human hair is about 80 000 nm wide and a
water molecule is almost 0.3 nm across. Nanoparticles can comprise a range of
different morphologies including thin films, nanotubes, nanowires, nanodots and
a range of spherical or aggregated dendritic forms. Nanotechnology involves
structures in the range 1 to 100 nanometres.[270]
7.5
Interest in nanoparticles is increasing significantly
as the properties of materials in nanoparticle form can have very different or
enhanced properties compared with the same material at a larger scale. Advances
in technology have also allowed atoms and molecules to be examined and probed
with great precision leading to the expansion and development of nanoscience
and nanotechnologies.
7.6
The properties of materials at nanoscale vary
significantly from those at bulk size for two main reasons. First nanomaterials
have a relatively larger surface area when compared to the same mass of
material produced in a larger form. This can make materials more chemically
reactive and affect their strength or electrical properties. Second, quantum
effects can begin to dominate the behaviour of matter at the nanoscale –
particularly at the lower end – affecting the optical, electrical and magnetic
behaviour of materials.[271]
7.7
Nanoscience is concerned with understanding these
effects and their influence on the properties of materials. Nanotechnologies
aim to exploit these effects to create structures, devices and systems with
novel properties and functions due to their size.
7.8
These materials have application in a wide range of
industries including electronics, pharmaceuticals, chemical-mechanical
polishing and catalysis. For example, very thin coatings are used in
electronics and active surfaces (self-cleaning windows). Carbon nanotubes have
great tensile strength and are considered to be 100 times stronger than
steel whilst being only a sixth of its weight thus making them potentially the
strongest, smallest fibre known.[272]
Titanium dioxide is used in sunscreens and self-cleaning glass and as a photo
catalyst. Nanoscale silicon is used in semiconductor manufacturing while metal
core coated particles are used to create quantum nano-dots that allow high
sensitivity labelling in a range of chemical or environmental settings.[273] Stain and wrinkle-free fabrics
incorporating 'nanowhiskers' and longer lasting tennis balls using
butyl-rubber/nanoclay composites are now being marketed.[274]
7.9
Nanoparticles are mostly fixed or embedded in nanoscale
components. In some instances, free nanoparticles are used, for example in
cosmetics.
7.10
Certain industrial by-products can be considered to contain
nanoparticles, for example from combustion engines (diesel particulate material),
furnaces and welding. There are also naturally occurring nanoparticles
associated with sand storms and forest fires. Most debate centres around the
new field of engineered nanoparticles.
Investment in nanotechnologies
7.11
Worldwide the investment in nanotechnology research and
development has increased dramatically over recent years. Governments in many
countries are funding research and manufacturers are already marketing a wide
range of products. The United States
invests approximately US$3 billion annually in nanotechnology research and
development, which accounts for approximately one-third of the total public and
private sector investments worldwide.[275]
7.12
In the United Kingdom
there are some 370 companies currently involved in nanotechnologies.[276] Some 1500 companies internationally
have announced nanotechnology research and development plans, 80 per cent of
which were start-up companies.[277]
7.13
The Woodrow Wilson International Centre for Scholars in
the USA has established
the Project on Emerging Nanotechnology to encourage discussion about
nanotechnology's benefits as well as its safety and environmental impacts. As part
of this project it has established the Nanotechnology Consumer Products
Inventory which, at March 2006, contained more than 200 manufacturer-identified
nano products.[278]
7.14
In Australia,
there are over 50 Australian companies focussed on nanotechnology. Australian
nanotechnology research spans materials, biotechnology, energy, environment,
electronics, photonics, computing and surveillance. The Australian Research
Council currently funds more than 200 nanotechnology research projects.
Australian universities, CSIRO, the Australian Nuclear Science Technology
Organisation and the Defence Science Technology Organisation are also active in
nanotechnology research and development.[279]
The PMSEIC Working Group estimated that at 2003, government and the private
sector were investing up to A$100 million per annum in nanotechnology, with at
least half from government sources.[280]
7.15
It has been estimated that the sales of products
incorporating emerging nanotechnologies will rise from 0.1 per cent of global
manufacturing output in 2004 to 15 per cent in 2014, totalling US$2.6 trillion.[281]
7.16
The United States National Institute for Occupational
Safety and Health (NIOSH) reported that there is no current comprehensive data
from official survey sources on the number of people employed in the US
in occupations or industries in which they might be exposed to engineered
nano-diameter particles in the production or use of nanomaterials. However, a
2004 survey estimated that some 24 300 people were employed in companies
engaged in nanotechnology (this included all people employed in the company).[282]
7.17
Friends of the Earth estimated that there are as many
as 700 people in Australia
who are currently employed in activities in which they may be regularly exposed
to synthetic nanoparticles in some form. Friends of the Earth commented that this
figure 'seems reasonable' as there are now over 50 Australian companies
focussed on nanotechnology and the Australian Research Council is currently
funding more than 200 nanotechnology research projects. It was estimated that
this number is likely to at least double over the next five years.[283]
7.18
The National Science Foundation estimated that in 2015
there will be 2 million workers employed in nanotechnology-related
industries worldwide; the number of people in secondary industries using
nanotechnology-related materials and devices will be orders of magnitude
greater.[284]
Health and safety concerns
...nanotechnology presents new and very serious risks that are
currently affecting workers and the public and, as industrial expansion
continues, will impact further upon the environment. There is early evidence of
serious harm and there are warnings from the world's most eminent scientific
body in relation to nano risks. We also have warnings from the world's
second-largest reinsurer that, in order to prevent a repeat of the asbestos
experience, we need conservative regulation that puts safety first now and that
catches up to the industry expansion.[285]
7.19
Various studies and reports point to the lack of
information concerning the human health and environmental implications of
manufactured nanomaterials. However, it is generally considered that there is
an inverse relationship between toxicity of insoluble materials and particle
size, irrespective of parent material.[286]
The UK Health and Safety Executive noted that 'the toxicity of insoluble materials
increases with decreasing particle size, on a mass for mass basis'.[287] It was also noted that unlike
larger microparticles, nanoparticles are highly mobile and readily enter the
blood stream following inhalation or ingestion. Nanoparticles may also
penetrate human skin.[288]
7.20
It is generally believed that the principal
determinants of toxicity of nanoparticles are:
-
chemical reactivity of the surface (including
any surface components such as transition metals or coatings and particularly
any ability to take part in reactions that release free radicals);
-
total surface area presented to the target
organ;
-
physical dimensions (which could influence
penetration and removal in the body); and
-
solubility (soluble particles may disperse
before initiating a toxic reaction).[289]
7.21
The Minerals Council of Australia noted that significant
research has identified that inflammation is a primary health effect and
oxidative stress can be identified as a dominant mechanism in the production of
this inflammation.[290]
7.22
Friends of the Earth also cited a research report which
showed that inhaled nanoparticles penetrate the protective mucus lining of
human lungs and have high rates of deposition in the deeper lungs. Scavenger
cells usually intercept foreign bodies and larger sized particles that make it
past the mucus lung lining and into the deeper lung. However studies have shown
that these cells have difficulty recognising nanoscale particles, they are
readily overloaded, and their action is impaired.[291] Reports also indicate that
nanoparticles are associated with inflammatory lung injury and laboratory
studies have shown that nanoparticles are transported around the body and are
absorbed by organs and tissues including the brain, heart and liver. Ingested
nanoparticles can be absorbed into the lymphatic system.[292] Friends of the Earth commented:
The effect of [the] characteristics [of nanoparticles] is that
nanomaterials have an unprecedented access to the body through inhalation,
ingestion and dermal contact, so all the ways that material can have access
into our bodies, and also to the bloodstream by other dermal contact. Once in
the body, nanomaterials have unprecedented access to vital organs and tissues,
including the heart and liver, bone marrow and reproductive organs. They even
have access to the brain along the olfactory nerve and across the blood-brain
barrier. Unlike larger particles, because nanomaterials are very small
particles, they gain access to individual cells. The toxicological impact on
organs and individual cells is still poorly understood, but some preliminary
research has come out in the last couple of years, the results of which we
believe are very concerning.[293]
7.23
Friends of the Earth also noted that the duration of
deposits of nanoparticles in vital organs is unknown, 'although there is some
evidence to suggest they may accumulate in organs such as the liver'.[294]
7.24
The Australian Council of Trade Unions (ACTU) informed
the Committee that there are concerns that nanoparticles may possibly cause Alzheimer's
disease. Rachel's Environmental and
Health News in 2003 reported that nanoparticles combined with metals can pass
directly into the brain where they can promote the formation of waxy amyloid
plaques which are the signature feature of Alzheimers. Rachel's Environmental and Health News has also warned of the risks
of industrial production of nanoparticles 'similar to those old-style
ultrafines already established to be prolific killers'. Rachel's
concluded 'clearly, in the case of nanoparticles, we have reasonable suspicion
of harm, and we have some remaining scientific uncertainty. There we have an
ethical duty to take preventive (precautionary) action. If there ever was a
proper time to invoke the precautionary principle, this is it.'[295]
Occupational health and safety
issues
7.25
A number of key concerns with the developments in
nanotechnology have been identified in evidence:
-
lack of knowledge about key aspects of how
nanoparticles impact on health;
-
lack of effective methods to measure and assess
workplace exposure to nanoparticles;
-
poor understanding of existing workplace
exposure;
-
lack of consistent nomenclature and terminology for
describing nanoparticles (for example whether to define nanoparticles by
physical dimensions or behavioural properties);
-
no effective control methods to safeguard
against exposure to nanoparticles and other nanomaterials;
-
problems with regulatory regimes unable to meet
the demands of a rapidly emerging new field of products and technologies; and
-
the small investment in occupational health and
safety aspects of nanotechnology.
Impact on health of workers
7.26
As noted above, nanoparticles appear to have the
potential to cause harm. The US National Institute for Occupational Safety and
Health (NIOSH) noted potential health concerns including exposure routes;
effects seen in animal studies indicating adverse health effects; and
observations from epidemiological studies involving fine and ultrafine
particles indicating adverse lung and respiratory outcomes.[296]
7.27
The Australian Institute of Occupational Hygienists (AIOH)
noted that reports by the UK Health and Safety Executive indicated how limited
the available data was and the difficulty of reading across from existing data
and that the hazards from nanoparticles and fibres are sufficiently different
from bulk materials to require further careful study. They also indicated that
the areas of initial occupational health concern should be:
-
potential for enhanced toxicity;
-
potential to cross the skin barrier;
-
existing control measures are unproven; and
-
possible persistence in the workplace.[297]
7.28
Witnesses drew parallels between nanoparticles and
asbestos. The Australian Manufacturing Workers Union (AMWU) commented that
asbestos had exacted a very high toll in Australia,
as we now have the 'unenviable distinction of having the highest mesothelioma
rate in the industrialised world'. Furthermore:
It would be an act of negligence to future generations if we did
not heed the concerns now being raised in the research community about the
health effect of nanotechnology.[298]
7.29
Friends of the Earth also commented on the parallels
between workplace exposure to asbestos and nanoparticles in that exposure to
nanoparticles has the potential to cause serious pulmonary disease. Friends of
the Earth commented further:
We are not just talking one asbestos; we could be talking five,
10, 100, 1,000, 10,000. No-one knows, because serious harm to health will only
manifest over the long terms and it is an omnipresent risk. As I mentioned
earlier, nanomaterials are already in the environment.[299]
7.30
Friends of the Earth noted that the international
insurer, Swiss Re has stated that the most important similarity between
asbestos and nanoparticle exposure may be the lag time before the potential
onset of serious harm to health – resulting in significant human and financial
cost. To safeguard against a repeat of the asbestos experience, Swiss Re has
advocated a strict application of the precautionary principle in the regulation
of nanotechnology and that health and safety first must be foremost in any
regulatory regime:
Swiss Re emphasised that there is a really clear economic
impetus to pursuing a precautionary approach to the regulation of
nanotechnology. It warned that delayed action and inadequate regulation of
workplace risk will result in a repeat of the asbestos experience. It is
particularly concerned about liability for the insurance sector.[300]
Measurement and monitoring of
nanoparticles
7.31
The AIOH raised concerns about how dust samples are
collected and measured:
...we have a 21st century technology there but we are still
thinking in 20th century terms about how we collect dust samples, how we
measure them and how we use things like respirators and ventilation or
enclosures to contain the dust. These nanoparticles are so fine that we cannot
use existing monitoring methods to assess how much exposure a worker is
receiving. If we do tell workers to wear a respirator, we have no real means of
telling if the respirator can protect them, because if these particles are so
fine they will just go straight through any filter or around the side of the
face seal. We do not know if ventilation is going to capture dusts containing
nanoparticles. We really are in the dark at the moment about the hazards and
the means of controlling the hazards, if there are any, from nanotechnology.[301]
7.32
Friends of the Earth also echoed these concerns and
noted for example that at the moment 'we are in a situation where, for
instance, you look at zinc dioxide and five different measuring instruments
come up with five different sizes. One will say it is 10 nanometres, the next
one will say it is 100 nanometres. Which one is it? And the size will have a
very important effect'.[302] There is
also no internationally agreed nomenclature: 'If you cannot describe
nanoparticles, how can you measure them? How can you do the safety assessments
and how can you set the workplace exposure standards?'[303]
7.33
NIOSH has also pointed to the difficulties of measuring
nanoparticles in the workplace:
...nanomaterials differ in significant ways from traditional
materials for which established measurement procedures and equipment exist. One
factor involves instrumentation: in general, available devices and methods are
not designed to take and analyse samples at the nano-scale. Another factor
involves uncertainties regarding the appropriate parameters for sampling and
analysis. Procedures for measuring traditional materials are based on the
particles' mass and bulk chemistry as characteristics that most determine
whether the material is likely to have adverse effects. For nanomaterials,
current research suggests that mass and bulk chemistry may be less important
than particle size, surface area and surface chemistry (or activity) as the
most relevant parameters for measurements.[304]
7.34
In November 2005, the International Organisation for
Standardisation (ISO) established the Nanotechnologies Technical Committee. The
national standards institutes of 24 member countries are participating, while
another eight have observer status. Specific tasks for the Technical Committee
include developing standards for: terminology and nomenclature; metrology and
instrumentation, including specifications for reference materials; test
methodologies; and science-based health, safety and environmental practices.[305]
Regulatory regimes
7.35
GeneEthics pointed to
the novel features of nanoparticles and the need for these to be addressed in
regulatory regimes:
Nanoparticles...are largely unresearched at this point. Our
regulators are assuming that nano sized particles of minerals and chemicals
that are already approved by them are going to behave in the same way as the
approved substances. It is now becoming clear that those assumptions are
incorrect and yet there is no mechanism for ensuring that the nano sized
particles of those substances are re-evaluated, that new scientific data be
generated and available for assessment when there are applications for its use.
The use of nanoparticles in cosmetics, for example, logically ought to be
regulated by the Therapeutic Goods Administration but, as it is cosmetics, is
not regulated by anybody.[306]
7.36
Workplace Health and Safety Queensland (WHS), noted
that some nanoparticles exposures already occur from aerosols in existing Queensland
industries such as pharmaceutical manufacturing, aluminium smelting, welding
processes, soldering, metal grinding and thermal coating. However, WHS went on
to state that it 'possesses no capacity to assess accurately the health impacts
from particle sizes specifically in the nanometre range or the possible
preponderating influence of their massive numbers'.[307]
7.37
Friends of the Earth also commented on the difficulties
of regulatory regimes addressing the particular characteristics of
nanoparticles:
Each and every nanomaterial is different from the next one, so
there is a nanomaterial that is zinc oxide, titanium dioxide, various carbon
formations, and the list goes on and on. There will be literally tens of
thousands of different nanomaterials. Each and every one of them is going to be
different from the next one because each and every one will be manufactured in
a slightly different way. It will have a different shape, different surface
properties, different surface areas.
While we have a general indication that they have particular
characteristics in common, some of them will be just fine and others will not
be nice at all.[308]
7.38
Friends of the Earth also informed the Committee that the
European Union and the US
have decided not to require new safety testing for certain products that are now
used in nanoscale, based on the known safety of those substances at a
macroscale. These products included titanium dioxide and zinc oxide which at
the nanoscale are used in sunscreen: 'that same sunscreen has been shown to
cause DNA damage and to have a carcinogenic impact in human skin cells in
in-vitro studies, and in human colon cells as well'.[309]
7.39
The lack of regulatory activity 'is in no small part
related to the huge gaps in knowledge that still exist around nanotechnology
and that confound our ability to adequately assess risk and to bring in
regulations that will guarantee workplace safety'. Friends of the Earth
commented that there are no mechanisms in place to enable risk assessment to be
undertaken and regulations to be developed to protect workers in the workplace
'yet we have many thousands of workers...in Australia who may be exposed to
nanoparticles, who are working in a wholly unregulated environment'.[310]
Occupational health and safety
research funding
7.40
GeneEthics proposed
that a minimum of 25 per cent of the budgets of all nanotechnology research and
development, both privately and publicly funded, be allocated to experiments on
worker, public and environmental health and safety.[311] In support of this view, GeneEthics
stated:
There is some small research being done [on safety] but, in our
view, a substantial amount – and we have suggested a quarter, though it is really
quite an arbitrary figure – should be expended on finding out in advance what
the impacts are likely to be. The behaviour of each kind of nanoparticle,
though it will be different from larger particles of the same substance, will
vary, and so there is a substantial amount of research that needs to be done to
understand where these things bioaccumulate, if they do, and how mobile they
are in the environment.[312]
7.41
Friends of the Earth also noted that there was a very
small amount of investment in research on occupational health and safety
compared with the amount invested in other research:
The amount of money that has been invested into looking at its
potential health and safety implications, its toxicological impacts and its
environmental implications is extremely small. There is a dearth of peer
reviewed toxicological literature looking at this stuff, and yet, of the stuff
that has been published, the overwhelming majority of the studies have rung
serious alarm bells. There are very few studies that have been undertaken into
the impact of nanotechnologies that have not pointed to serious problems.[313]
Response to concerns
7.42
The AIOH concluded that the lack of knowledge about the
possible health impacts of nanotechnology placed a great responsibility on
those involved in the development, import, marketing and distribution of emerging
technology products to ensure that workers will not suffer any adverse response
from being exposed to these products in their workplaces. AIOH saw a need for
those involved in the development of products to ensure that adequate
information is provided to users to ensure they are able to use the technology
safely. AIOH considered that further product testing may be required and there
are parallels with existing schemes for controlling the introduction of new
chemicals, such as the National Industrial Chemicals Notification and
Assessment Scheme (NICNAS). AIOH recommended that nanoparticles should be
referred to NICNAS for assessment.[314]
7.43
The AMWU identified key areas for action including:
-
government needs to ensure that the risks of
nanomaterials are identified before they are incorporated into products for
commercial production, for example through NICNAS;
-
funding for research on health and environmental
implications of nanotechnology, including collaborative research ventures with
overseas bodies, to ensure that critical research is conducted to identify
potential risks;
-
comprehensive management of the risks that are
identified including identifying changes needed to address current gaps and
uncertainties that may be creating regulatory 'nano-loopholes';
-
urgent investigation and regulation of
nanoparticle exposure levels to the lowest possible level, until a safe and
healthy exposure standard can be adopted particularly in scientific research
and commercial research and development departments;
-
industry itself needs to develop and drive
widespread adoption of 'standards of care' for responsible nanotechnology
development; and
-
engagement of stakeholders outside government
and industry whose constituencies stand to be both beneficiaries of this
technology and those most likely to bear any risks that arise.[315]
7.44
The ACTU also echoed
these concerns and recommended that urgent research be undertaken into the
risks posed to workers and the public by nanomaterials and into techniques to
eliminate the risk of exposure.[316] It
also called for a national conference on nanotechnology at which regulators,
hygienists, scientists, lawyers, researchers, unions, business, medicos, and community
groups could be brought together to discuss the impact of nanotechnology. In
particular it could look at regulating the exposure levels of workers to
nanoparticles; how to label products that contain nanoparticles; monitoring the
workplaces that expose workers to nanotechnology and nanoparticles; and screening
workers. The ACTU commented that workers and consumers are already being
exposed to nanoparticles:
These products are out there at the moment. They are currently
being used potentially by millions of Australians. We use a lot of sunscreen.
We need to know what impact these products are having on consumers and we also
need to look at who is producing these things and how prevalent they are. There
is no regulation about what products are being produced using nanotechnology.
We do not know. It is a minefield. If – a worse case scenario – nanotech and
nanoparticles cause serious harm to people, we are sitting on a bit of a time
bomb. Let’s face it! We do not know enough.[317]
7.45
Friends of the Earth, supported by the GeneEthics
Network, called for a moratorium on all research, development, commercial production
and sale of synthetic nanotechnologies, nanoparticles, and other nanomaterials
and products that contain them. The moratorium should remain in force, at a
minimum, until new laws and a regulatory system are developed and implemented. This
should include a nomenclature, a way of measuring risk, a way of assessing risk
and until safety assessments have been undertake so that there is a better
understanding of the toxicological interaction between nanoparticles in the
body; and until there is a regulatory framework for assessing risk and
protecting health and safety.[318]
Friends of the Earth concluded:
The need to regulate workplace exposure is particularly urgent.
There are tens of thousands of Australian workers who are likely to be exposed
to synthetic nanoparticles, hundreds of thousands of workers exposed to
incidentally produced nanoparticles, and a growing body of evidence that such
exposure may relate in serious harm. Given the many uncertainties that continue
to plague the development of adequate nanotechnology regulation, a moratorium
on the research, development and manufacture of synthetic nanoparticles is
essential until a comprehensive regulatory regime is developed and implemented.[319]
7.46
GeneEthics Network
also proposed the development of a comprehensive, innovative regulatory
framework including the establishment of an Office of New Technology Assessment
and Regulation with responsibility for the registration, assessment, licensing
and monitoring of all new technologies. This office would be established under
a Council of Australian Governments agreement and be responsible to a New
Technology Ministerial Council, composed of Commonwealth, State and Territory
health ministers.[320]
7.47
The Department of Employment and Workplace Relations (DEWR)
stated:
DEWR's view is that a full picture of the potential health and
safety implications and risks of nanotechnology, if any, remain unknown. The
office will closely monitor international research on this topic and ensure
that key government agencies are kept informed of relevant developments. DEWR
is of the view that the current OHS regulatory framework is appropriate for
dealing with the potential risks associated with nanotechnology.[321]
Studies and reports into the potential impact of nanotechnology
7.48
Interest in the potential impact of nanotechnology has
increased over the last two to three years with the release of major reports by
international organisations. Studies into the implications of current and
future developments in nanoscience and nanotechnologies and their impacts have
been undertaken overseas. The following provides an overview of some of the
major reports and studies.
The Royal Society and Royal
Academy of Engineering – United
Kingdom
7.49
In July 2004, the Royal Society and Royal Academy of
Engineering reported on current applications of nanotechnologies and examined the
health, safety and environmental implications and uncertainties that may arise
from nanotechnologies.[322]
7.50
The Royal Society examined evidence from exposure to
quartz, asbestos, air pollution and medical applications of nanoparticles to
understand the toxicity of nanoparticles and fibres. It stated that the
understanding derived from this evidence had led it to the general conclusion
that the principal determinants of the toxicity of nanoparticles were the
surface area, chemical reactivity of the surface, the physical dimensions of
the particle that allow it to penetrate to the organ or into cells or that
prevent its removal; and possibly, its solubility.[323]
7.51
The Society concluded that whilst many applications of
nanotechnologies pose no new health or safety risk, manufactured nanoparticles
and nanotubes in a free form may pose health and safety risks. The Society saw
the main risk of human exposure to manufactured nanoparticles and nanotubes as
being in a few work places (including academic research laboratories) and
through the use of a small number of skin care preparations which contain free
nanoparticles. It commented however that 'the current lack of available
research means that the scale of this risk cannot be fully determined'. [324]
In addition, the Society stated:
There is virtually no evidence available to allow the potential
environmental impacts of nanoparticles and nanotubes to be evaluated. With the
exception of some experiments on laboratory animals...and one small study on one
species of fish, little information is available about the toxicity of
nanoparticles to non-human species.[325]
It was concluded that:
There are uncertainties about the risk of nanoparticles
currently in production that need to be addressed immediately to safeguard
workers and consumers and support regulatory decisions.[326]
7.52
The Society made 21 recommendations. These included,
that given the lack of evidence about the risk posed by manufactured
nanoparticles and nanotubes is resulting in considerable uncertainty, that:
-
an interdisciplinary centre be established to
research nanoparticles and nanotubes including toxicity and exposure pathways,
and to develop methodologies and instrumentation for monitoring them in the
built and natural environment;
-
until more is known about the environmental
impacts of nanoparticles and nanotubes, that the release of manufactured
nanoparticles and nanotubes into the environment be avoided as far as possible.
In
relation to regulatory issues, it was recommended that consideration be given
to whether existing regulations are appropriate to protect humans and the
environment in relation to nanoparticles and nanotubes.
7.53
As a result of the novel properties of nanoparticles
and nanotubes, it was recommended that:
-
nanoparticles and nanotubes should be treated as
new substances under existing UK and European regulations;
-
that the adequacy of regulation of exposure to
nanoparticles be reviewed and that in the meantime consideration be given to
setting lower exposure levels for manufactured nanoparticles;
-
that ingredients in the form of nanoparticles
undergo a full safety assessment by the relevant scientific advisory body
before they are permitted for use in consumer products;
-
that manufacturers publish details of safety
tests to show how they have taken into account the novel properties of
nanoparticles in consumer products;
-
that the list of ingredients of consumer
products identify the use of manufactured nanoparticulate materials; and
-
that an interdisciplinary research program be
funded to investigate the social and ethical issues expected to arise from the
development of some nanoparticles.[327]
7.54
The UK Government's response to the report was released
in February 2005. The Government indicated that it supported the precautionary
stance taken by the Royal Society.[328]
As part of its response, it also announced the establishment of a Research
Co-ordination Group with a wide-ranging membership to ensure that a
comprehensive research program is developed that focuses on regulatory needs.
The Government also identified two main priority areas for research:
-
the development of robust and reliable
measurement and detection technologies for nanoparticles and nanotubes; and
-
work to underpin the robust assessment of
potential risks associated with nanoparticles and nanotubes, particularly their
toxicology.[329]
7.55
In relation to consumer products, the UK Government
agreed that ingredients in the form of manufactured free nanoparticles should
undergo a full safety assessment before being used in products and that the use
of nanoparticles should be indicated on labels.[330]
7.56
In November 2005, the UK Government produced the first
report on on-going and projected research on potential risks posed by
engineered nanoparticles as foreshadowed in response to the Royal Society
report.[331] Three key areas were
identified where further research is needed to develop a risk management
framework for nanoparticles:
-
properties, characterisation and metrology,
including standardisation;
-
human and environment exposure; and
-
hazard to human health and the environment.
A fourth area is understanding the societal and ethical
dimensions of nanotechnologies as they arise. Overarching this is a need for
the development of, and international agreement on, nomenclature and definitions.[332]
National Institute for Occupational
Safety and Health – United States
7.57
The National Institute for Occupational Safety and
Health (NIOSH) has noted that:
There are still many knowledge gaps to be filled before we fully
understand how to work safely with these materials. Until these and other
research questions are answered, it is prudent to proceed with caution when
working with nanomaterials.[333]
NIOSH has stated that the information gap is 'critical
because of the unknown risk that nanomaterials pose to workers'. NIOSH pointed
to studies in rats where ultrafine particles caused pulmonary inflammation and
lung tumors and commented that 'if engineered nanoparticles involve the same
characteristics that seem to be associated with ultrafine particles, they may
raise concerns'.[334]
7.58
NIOSH has formulated strategic goals for its
nanotechnology research agenda including the need to understand and prevent
work-related injuries and illnesses possibly caused by
nanoparticles/nanomaterials. To achieve this goal, NIOSH stated that there is a
need to determine the toxicity of nanomaterials, identify possible health
effects from the early uses of these materials and monitor the on-going health
of individuals working with nanomaterials. There is also a need for research to
develop and validate methods of exposure assessment. In order to promote healthy
workplaces, there is a need to develop and evaluate engineering controls,
personal protective equipment and guidance on safe handling of nanomaterials
and to identify and improve safety issues in the workplace.[335]
7.59
NIOSH has identified the following critical
occupational safety and health issues arising from nanotechnology:
-
exposure and dose;
-
toxicity;
-
epidemiology and surveillance;
-
risk assessment;
-
measurement methods;
-
controls;
-
safety;
-
communication and education;
-
recommendations including evaluation and
updating of occupational exposure limits; and
-
applications: identification of uses of
nanotechnology for application in occupational safety and health.[336]
OECD – Working Party on
Nanotechnology
7.60
The OECD Working Party on Nanotechnology was
established under the Committee for Science and Technology Policy (CSTP) in
2005. The Working Party is to identify what member countries are doing in
nanotechnology and how members can cooperate to effectively use their
nanotechnology investments. The latest meeting of CSTP was held in March 2006
in Sydney.
7.61
The OECD is also considering a proposal to create
within the OEDC Environmental Directorate a working group focused on
environmental, health and safety risk assessment and the management of
nanomaterials.[337]
Royal Society-Science Council of Japan
Workshop
7.62
In July 2005 the UK Royal Society and the Science
Council of Japan held a joint workshop to consider the potential health,
environmental and societal impacts of nanotechnology. The key issues identified
by the workshop included:
-
the need to develop new measuring technologies;
-
the need for further research on exposure routes
within the body;
-
more research on nanomaterials and
carcionogenesis;
-
the need to develop internationally recognised
standard protocols for toxicology testing of nanoparticles;
-
to establish appropriate regulatory regimes
funding for research is required and the engagement of stakeholders including
the public; and
-
international collaboration and coordination of
research into toxicology of nanomaterials and the development of standardised
safety assessments is needed.[338]
International Risk Governance
Council
7.63
The International Risk Governance Council (IRGC) is
undertaking a nanotechnology project intended to address the need for adequate
risk governance approaches at the national and international levels in the
development of nanotechnology and nanoscale products. The project is funded by
the Swiss Federal Agency for Development and Cooperation, the US Department of
State and the Swiss Reinsurance Company.
7.64
As part of this project, the IRGC conducted a survey on
nanotechnology governance across 27 economies (including Australia).[339] A workshop was held in January 2006
to develop strategies and to review the survey. More than 45 recommendations
were identified for how risk governance of nanotechnology may be improved in
areas such as stakeholder engagement, communication and research. In July 2006,
a meeting in Zurich will be held to
discuss the recommendations of the survey and workshop.
Developments in Australia
Prime Minister's Science,
Engineering and Innovation Council (PMSEIC)
7.65
In March 2005, the Prime Minister's Science,
Engineering and Innovation Council (PMSEIC) working group on nanotechnology
presented its report. The working group's terms of reference included:
-
outline the importance and potential
applications of nanotechnology as an enabling technology to many industries;
-
examine what nanotechnology has delivered to
date;
-
scope Australia's international competitiveness;
and
-
identify major challenges and opportunities.[340]
7.66
The working group reported that there had been an
explosion in technological development worldwide between 2000 and 2005, global
investment had quadrupled (and exceeded US$8 billion per year) and important
practical applications of nanotechnology are emerging. The working group found
that Australia's
research base is strong and globally competitive. It stated that:
To capitalise on the opportunities presented by nanotechnology,
the challenge is to enhance the coordination of Australia's
nanotechnology effort, concentrate resources and accelerate industry uptake.[341]
Specific needs identified by the working group included:
-
the need for a national nanotechnology strategy
coordinated across all levels of government, to inform the public debate on
social, health and environment issues, and to provide an appropriate regulatory
framework;
-
the need to address emerging issues concerning
community awareness and acceptance of nanotechnology, as well as the
considerable ethical, social and safety implications;
-
the development of a comprehensive impact and
risk analysis framework must be seen as a high priority. This framework must
adopt a science-based risk identification, assessment and management process;
and
-
the development of a substantial Australian
skills base in nanotechnology is of fundamental importance to our
nanotechnology capability over the next decade.[342]
7.67
The working group made two recommendations:
-
That the Australian Government examine the
options for implementing a national nanotechnology strategy, with particular
emphasis on the framework under which the objectives of a national
nanotechnology strategy can be achieved.
This
national strategy should provide a broadly based framework to ensure that Australia
has a national and coordinated approach to nanotechnology; provision of high
level advice to governments; well-informed public awareness activities and
debate on social, health and environmental issues; and an appropriate
regulatory framework which safeguards the health and safety of Australians.
-
That an Australian nanotechnology business
alliance be formed with government support whose role is to overcome the
current fragmentation evident in the nanotechnology sectors, link business and
researchers, and enhance industry application of nanotechnology.[343]
National Nanotechnology Strategy
Taskforce
7.68
On 5 February
2006, the Minister for Industry, Tourism and Resources, the Hon
Ian Macfarlane,
announced the formulation of a National Strategy for the development and
regulation of nanotechnology. The aim of the Strategy will be to best capture
the benefits of nanotechnology for Australia
whilst safeguarding health, safety and the environment. The Minister stated:
Australia
has an opportunity to be part of this world-wide movement towards smaller and
greater efficiency in many aspects of our daily lives, no only as developer of
the technology, but also as a responsible regulator of the field...
It is hard to imagine areas of our lives that won't be impacted
by nanotechnology so it makes sense to have a co-ordinated national approach,
with the State and Territory governments, to make sure Australia is 'nanotech
ready'.
From an industry perspective we have to capture the commercial
opportunities of developing this field but it is just as important that the
environment, health and social issues are understood and properly monitored.[344]
7.69
The National Nanotechnology Strategy Taskforce was
established to examine options for a coordinated national nanotechnology strategy
across Commonwealth and State and Territory Governments by 30 June 2006. A broad array of issues will be
examined including:
-
community awareness;
-
science capacity;
-
industry development and industry uptake;
-
investment and infrastructure;
-
regulation and metrology;
-
skills and training;
-
international engagement; and
-
environmental, safety and ethical issues.[345]
7.70
A series of consultations are being undertaken with
industry, science and the general community, as well as other Commonwealth government
portfolios and State and Territory Governments. A Reference Group representing
industry, science and community interests is working with the Taskforce. In
addition, the Taskforce released a discussion paper on issues to be considered
in a National Nanotechnology Strategy.
Office of the Australian Safety and
Compensation Council
7.71
The Office of the Australian Safety and Compensation
Council (see Chapter 1) currently maintains a watching brief on the OHS
developments with respect to nanotechnology and reports to Australian
Government (Comcare), State and Territory OHS authorities, ACCI and ACTU. The
Office represents DEWR on an interdepartmental committee on nanotechnology,
organised by the National Nanotechnology Strategy Taskforce within the
Department of Industry, Tourism and Resources. The role of the Office on this
committee is to provide input on OHS issues.[346]
National Industrial Chemical
Notification and Assessment Scheme (NICNAS)
7.72
NICNAS commenced active consideration of nanomaterials
and their regulation in 2004-05. NICNAS is a member of the OECD Steering Group
for Nanotechnology.
7.73
In February 2006, NICNAS issued a voluntary call to
companies to provide information on uses and quantities of nanomaterials imported
or manufactured for industrial uses, or used in cosmetics and personal care
products. NICNAS will prepare a report on the extent and scope of the use of
nanomaterials in industrial, cosmetic and personal care products in Australia.
In its call for information, NICNAS stated:
It is important and timely that NICNAS considers nanomaterials,
their potential health and environmental impacts, and the ability of the [industrial
chemicals national notification] scheme to adequately assess the potential
risks of nanomaterials.[347]
7.74
NICNAS also stated that nanomaterials used exclusively
as therapeutic goods (such as sunscreens), food or food additives and
agricultural or veterinary chemicals, do not fall within the scope of NICNAS.
7.75
To March 2006, no nanomaterials had been assessed by
NICNAS.
Therapeutic Goods Administration
7.76
The Therapeutic Goods Administration (TGA) has issued
advice on their website about the safety of sunscreens. The TGA is keeping a
watching brief on the scientific literature with regard to the safety of
nanoparticulate materials used in medicines, for example zinc oxide in
sunscreens.
Conclusion
7.77
At the nanoscale, materials exhibit novel properties
that affect their physical, chemical and biological behaviour. The Committee
considers that the use of nanomaterials has enormous potential in many areas from
medicine to computing and electronics. Indeed, nanotechnology may be as
significant as the discovery of electricity or the microchip. At the same time,
the Committee is mindful that the application of nanotechnology will have implications
for workers' health and safety, for individuals through consumer and medical
products and for the environment.
7.78
How significant those implications will be,
particularly the hazards to human health, is unclear at the present time. The
adverse effects of nanoparticles cannot be predicted from their known characteristics
at larger scale and there are still major gaps in current knowledge of how
nanoparticles enter the human body and how they impact on health including
disease-causing effects. There are also problems with how nanoparticle exposure
can be measured and assessed in the workplace and the environment.
7.79
The Committee has noted the outcomes of studies and
reports from overseas, which have identified areas were further research is
required. A key priority for occupational health and safety is the measurement
and assessment of nanoparticles so that adequate regulatory frameworks can be
developed. For nanoparticles, the use of traditional exposure regimes based on
mass concentrations alone are insufficient as the surface area and physical
dimension of nanoparticles play a key role in toxicity. These characteristics
will require modification of the present regulations on exposure standards,
risk assessment and methodologies and equipment needed to undertake measurements
to ensure worker safety.
7.80
Nanotechnology holds great opportunities but also great
responsibilities. The Committee considers that there is a need for continued international
cooperation to address concerns raised by nanotechnology and acknowledges the
Government's contribution to international forums such as the OECD Working
Party on Nanotechnology.
7.81
The Committee also welcomes the establishment of the
National Nanotechnology Strategy Taskforce. A national nanotechnology strategy
is required as a matter of priority: nanotechnology is a rapidly emerging field
attracting more and more investment everyday with workers already being exposed
to nanoparticles. Governments overseas have responded to concerns about
nanotechnology and a number of authoritative reports and studies are available.
Any delays in formulating an Australian national strategy will only impede the
consideration of significant regulatory, environmental, safety and ethical
issues that must be addressed.
7.82
The Committee does not agree that a moratorium on
nanotechnologies is needed but considers that safety of workers and the
community must be paramount. This means that the exposure of those workers
already working with nanoparticles must be minimised and that new
methodologies, means of assessment and equipment being developed in Australia
and overseas must be incorporated into the regulatory framework as soon as they
are available.
7.83
The Committee also considers that the Australian regulatory
framework needs to be flexible to address the novel characteristics of nanoparticles
and that mechanisms are required so that all Commonwealth Government regulatory
agencies address regulatory developments overseas and their significance for the
Australian regulatory framework.
Recommendation 12
7.84
That the National Nanotechnology Strategy be finalised
as a matter of priority.
Recommendation 13
7.85
That a working party on nanotechnology regulation consisting
of representatives of the Therapeutic Goods Administration, NICNAS and the
Australian Safety and Compensation Council be established to consider the
impact of the emerging field of nanotechnology on the regulatory framework
including:
-
whether existing regulations are appropriate;
-
how gaps and uncertainties in the regulatory
framework can be addressed;
-
how comprehensive management of risks of
exposure to nanoparticles can be incorporated into the regulatory framework;
-
whether Australia will require materials,
already classified as safe at the macroscale, to be reassessed if they are to
be used at the nanoscale; and
-
whether there is a need for the establishment of
a permanent body to regulate nanotechnology.
The working party should
consult with stakeholders including consumer groups, State and Territory
governments, unions, industry, health organisations and the public and provide
a public report on these issues by March 2007.
Recommendation 14
7.86
That Commonwealth agencies including the Office of the Australian
Safety and Compensation Council and NICNAS actively pursue links to overseas
regulatory and research bodies to ensure that they are kept fully informed of
developments in the rapidly emerging field of nanotechnology.
Senator Claire
Moore
Chair
May 2006
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