CHAPTER 4: Health and Safety |
Known risk factors associated
4.1. The application of nanotechnologies to the
food sector offers potential benefits (see Chapter 3). But concerns
have also been raised about possible health and safety risks to
consumers. Whilst much of the discussion is about potential
risks, some instances of actual health consequences have been
reported. For example, one study found that multi-walled carbon
nanotubes injected into rodents caused lesions in the peritoneal
(abdominal) cavity not dissimilar to those that occur in the pleural
(lung) cavity with asbestos exposure.
Another report published in 2009 described immune responses to
foreign bodies and the collection of fluid in the lung cavity
following exposure by inhalation to polyacrylate nanoparticles.
We received no evidence, however, of instances where ingested
nanomaterials have harmed human health.
4.2. The novel properties of nanomaterials may
affect how such materials interact with the body and the risks
they present to human health. A report, by the European Union
Scientific Committee on Emerging and Newly Identified Health Risks
(SCENIHR), published in 2009, listed a number of physical and
chemical properties which affect the risk associated with nanomaterials.
The evidence we received focused on six properties that may be
particularly relevant when considering how nanomaterials interact
with the body after they have been ingested and enter the gastro-intestinal
4.3. Nanomaterials offer a vast range of different
properties, and the risks they present will vary accordingly.
While some types of nanomaterials may well pose little threat
to human health (pp 112, 335) others may prove to be more
4.4. The small size of nanomaterials may give
rise to a risk to human health irrespective of any other novel
properties. Dr Qasim Chaudhry, Senior Scientist at DEFRA's
Food and Environment Research Agency, explained that: "Cellular
barriers prevent the entry of larger insoluble particulate material;
but nanoparticles, because of their very small size, can override
that" (Q 215). The MRC Collaborative Centre for Human
Nutrition Research reported that, as a rough guide, particles
smaller than 100nm "will be taken up by cells through a different
pathway to that of larger particles, meaning that they will access
different cellular compartments and have different cellular effects"
(p 113). Research indicates that nanoparticles are able to
penetrate cell membranes of the lining cells of the gut (the epithelium)
(p 111). If they pass through the entire epithelium they
will enter either the tissue wall of the gut, or lymphatic vessels,
or directly into the bloodstream, either as free particles or,
following their ingestion, into circulating white blood cells.
4.5. The exceptional mobility of nanomaterials,
both inside and outside cells, gives them the potential to "access
all areas of the body, even the brain and all areas of the cell,
including even the nucleus. It is this
suggested the MRC Collaborative Centre for Human Nutrition Research,
"that probably makes very small nanoparticles most worrisome
to scientists" (p 113). Professor Vyvyan Howard,
Professor of Bio-imaging at the University of Ulster and
an adviser to the Soil Association agreed (Q 283). Professor
Ken Donaldson, Professor of Respiratory Toxicology at the
University of Edinburgh, described his work on the impact of nanoparticles
in the lungs: "there is a hypothesis that there is also translocation
nanoparticles to the blood and the brain", and
although "there is no evidence currently that the translocation
of nanoparticles out of the lung occurs in humans or leads to
any adverse effect
it is possible, even likely" (p 101).
SOLUBILITY AND PERSISTENCE
4.6. Another concern is whether ingested nanomaterials
which can enter cells and migrate to different parts of the body
will accumulate in certain organs. The question is whether a nanomaterial
entering the body is broken down into its constituent parts (and
either metabolised or the components excreted), in which case
its toxicity is related to its chemical composition rather than
its size (Q 215), or whether it enters the gut with the novel
properties associated with the nanoscale intact. In Dr Chaudhry's
view, "if nanomaterials are solubilised, digested or degraded
within the gut then they are of least concern
concern is on insoluble, indigestible, non-degradable nanoparticles
that can survive mechanisms in the gut" (Q 216). Dr Kampers
agreed: "toxicologists agree that the persistent nanoparticles,
especially those that are non-biologically degradable, inorganic,
the inorganic metal oxides and metals, are the particles that
pose the most risk" (Q 89).
4.7. Persistent nanomaterials might be harmful
because they could "become lodged into the cells and tissues
and get accumulated over time", causing adverse effects
in the "medium to long-term" (Q 218). The European
Food Safety Authority's (EFSA) Scientific Opinion on nanomaterials
stated: "There are only limited data on potential, long-term
accumulation/persistence of ENMs [Engineered Nanomaterials]. However
the limited data available suggest that insoluble ENMs may be
retained for a long time and accumulate";
and a joint statement on nanomaterials toxicology by the UK Committees
on Toxicity, Mutagenicity and Carcinogenicity of Chemicals in
Food, Consumer Products and Environment (COT, COM, COC) warned
that "nanoparticles resistant to degradation could accumulate
in secondary lysosomes, which in cells with a long survival such
as neurones or hepatocytes might lead to chronic toxicity".
Dr Jonathan Powell, Head of Biomineral Research at the MRC
Collaborative Centre for Human Nutrition Research, told us that
"certain areas of the gut
with increasing age accumulate
quite clearly accumulation does occur"
(Q 242). Professor Donaldson agreed that a nanomaterial
that reaches the blood "circulates round the body and accumulates
in various organs at low levels" (Q 242), and added
that the impact of this accumulation is unknown.
CHEMICAL AND CATALYTIC REACTIVITY
4.8. The large surface area to mass ratio of
nanomaterials means that they tend to be very reactive. This can
be harmful. Dr Chaudhry, for example, said that it might
cause them to interfere with normal cellular processes, causing
"inflammatory reactions and oxidative damage" (Q 215).
The MRC Collaborative Centre for Human Nutrition Research made
a similar point, stating that the direct toxicity of particles
is mediated through "free radical" activity and such
activity is considerably greater in smaller particles than in
the same mass of larger particles (p 112). Recent studies
in fish have shown
not only uptake of nanomaterials into the gills and gut, but also
evidence of an inflammatory response which was also present in
the brain and other organs.
4.9. Furthermore, because of their reactivity,
nanomaterials will bond with other substances in the product in
which they are ingested or in the GI tract itself (for example,
bacterial toxins), thereby providing a vehicle by which these
toxins can be delivered across cellular barriers which they could
not normally crossdescribed by Dr Powell as a "Trojan
Horse effect" (Q 216). According to Dr Powell,
is full of bacterial toxins" and particles
"have the ability to bind to their surface these kinds of
toxins and other molecules and can, at least in theory, and we
now have evidence for this, carry them across into the gut mucosa"
(Q 277). Dr Chaudhry also described how nanomaterials
could "carry harmful substances out of the gut into the blood
circulation from where they can lead to other parts of the body"
4.10. The shape of a particle may have an impact
on the possible harmfulness of nanomaterials (p 112). Professor Donaldson,
for example, referred to the potential toxicity of "carbon
nanotubes and other high aspect ratio nanoparticles (HARN) because
of their superficial similarity to asbestos" (p 101);
and whilst this particular concern has tended to focus on damage
to the lungs and pleural lining, it might also possibly apply
to the gut (pp 101-102).
4.11. Nanomaterials which are used because of
their anti-microbial properties, for example nanosilver (also
used to coat devices such as refrigerators (p 55)), may be
ingested through food packaging or food supplements. Dr Chaudhry
expressed a concern that their ingestion might have a harmful
effect on the natural flora in the gut (Q 215). Professor Donaldson
agreed: "another problem lies with the normal flora of the
gut, which could well be unbalanced if there was selective toxicity
towards commensals [bacteria naturally present in the body]silver
nanoparticles seem a particular threat in this area" (p 101).
4.12. According to the FSA, silver hydrosol,
a form of nanosilver, was recently evaluated by the EFSA for inclusion
on a European Union list of vitamins and minerals authorised for
use in food supplements. The EFSA was unable to complete a safety
evaluation since there was insufficient information available
to determine the potential effects of nanosilver on the human
body, and as a result, silver hydrosol is likely to be banned
from January 2010 (pp 2-3).
AGGREGATION AND AGGLOMERATION
4.13. The large surface area, reactivity and
electrical charge of nanomaterials create the conditions for what
is described as 'particle aggregation' (physical forces) or 'particle
agglomeration' (chemical forces), where individual nanoparticles
join together to form larger particles.
Just as the particle size can dramatically increase through these
processes, under different conditionsfor example in the
gut or inside cellscollections of nanoparticles could disaggregate,
thereby altering their physicochemical properties and reactivity.
Such reversible phenomena add to the difficulty in understanding
the behaviour and toxicology of nanomaterials.
Additional risk factors
4.14. Certain types of medical conditions may
make people more susceptible to the potential risks posed by ingested
nanomaterials. Diseases which cause gastrointestinal inflammation,
such as inflammatory bowel disease or chronic diarrhoea, may allow
nanomaterials to penetrate the intestinal wall more easily. In
the human lung the adverse susceptibility to particles is greatly
enhanced in those people who have inflammatory conditions of the
lung; Professor Donaldson speculated that, in this case,
"one would imagine the gut would be exactly the same"
(Q 217). Dr Powell agreed: "gut permeability is
enhanced in the presence of certain disease, including chronic
diarrhoea; and there is good evidence that small particles
will have enhanced permeability under these conditions" (Q 217),
a point also made by Professor Michael Depledge, Professor of
Environment and Human Health at the Peninsula Medical School (Q 217).
4.15. Our knowledge of the risks associated with
the use of nanomaterials is incomplete. Significant gaps remain.
The Government's Nanotechnology Research Coordination Group (NRCG),
a research coordination body for publicly-funded nanotechnology
research (see paragraph 4.29 below), published a report in November
2005 which identified 19 research objectives, grouped into five
areas (Q 18):
- Metrology, characterisation and
- Fate and behaviour in the environment
- Human toxicology
- Exposure, sources and pathways
- Social engagement.
4.16. In 2007, the Council for Science and Technology
(CST) carried out a review of the Government's progress on its
policy commitments following the RS/RAEng 2004 report. The CST
concluded that they had "placed insufficient emphasis on
the need to investigate the health, toxicology and environmental
effects of nanomaterials, despite such research being vital if
commercialisation is to ultimately succeed"
and that "the balance between research that develops new
applications of nanotechnologies and that which provides the necessary
underpinning for its safe and responsible development must be
The RCEP's 2008 report echoed this conclusion: "we are very
conscious of the extent to which knowledge about the potential
health and environmental impacts of nanomaterials lags significantly
behind the pace of innovation".
4.17. Evidence suggests that this remains the
case. In many areas there are still large gaps in our understanding
of how nanomaterials behave or affect the biology of living organisms
and, especially, human health. Our attention was drawn to a number
of areas where further research is said to be needed in order
to enable an effective risk assessment of nanotechnologies used
in the food sector:
- Characterisation and detection
- Behaviour of nanomaterials in
the gut (including local effects, absorption and subsequent distribution)
- Effects on the human foetus
- Food specific research
- Subsequent movement of nanomaterials
within the body (toxicokinetics)
- Chronic effects (toxicodynamics)
- Development of validated toxicological
CHARACTERISATION, DETECTION AND MEASUREMENT
4.18. Any understanding of nanomaterials must
begin with being able to detect, measure and characterise themin
particular, since many food products are naturally structured
at the nanoscale, any regulation or risk assessment must distinguish
between manufactured nanomaterials and those naturally occurring
in food (see Chapter 5). This is far from straightforward. According
to the FSA, "there are difficulties in characterising, detecting
and measuring engineered nanomaterials in food, feed and biological
matrices" (p 4), a point also made by Professor
Depledge who said "it is actually extremely difficult to
find the nanomaterials in the first place" (Q 218).
When we visited Unilever's R&D facility in Colworth, we were
shown the complex laboratory-based equipment necessary to detect
nanoparticles, including sophisticated technologies for sample
preparation and various forms of electron microscopy. Dr Knowles
referred to there being "a dearth of analytical methods which
would allow us to measure those
particles in a food matrix
or any biological matrix" (Q 170), a view shared by
Dr Chaudhry (Q 270).
BEHAVIOUR OF NANOMATERIALS IN THE GUT
4.19. The ingestion of nanomaterials is not a
new phenomenon. As well as nanomaterials that occur naturally
in food (see paragraph 1.4), human beings have always been exposed
to naturally occurring nanomaterials (for example, particles from
volcanic eruptions and natural fires) and exposure to man-made
nanomaterials (for example, those from fossil fuel combustion)
has taken place for decades (pp 101, 106). A large percentage
of inhaled nanoparticles are transported into the gut (p 101).
4.20. The GI tract is well adapted to facilitate
the uptake of certain nanomaterials (p 111). Some, those
which either break down into their chemical components when ingested
or pass through the digestive system intact, tend to pose less
risk to human health than nanoparticles which do not break down
and which may be absorbed through different sites in the GI tract
(see paragraphs 4.6 and 4.7 above). Dr Powell identified
four mechanisms through which the gut might absorb nanomaterials
4.21. To date, little research has been undertaken
into the impact, behaviour and interaction of nanomaterials in
the GI tract, including their effect on natural gut flora. In
contrast, a significant amount of research has taken place into
the effects of nanomaterials on the lung-according to Dr Knowles,
"most research has been, and continues to be, on inhalation"
(Q 170). But this work may not assist in understanding the
effect of nanomaterials that enter the body through ingestion
because, as Professor Donaldson told us, you cannot generalise
from the effects of particles in the lungs or on the skin to the
effects in the gut: "The gut is a wholly different environment
to me to these other situations in terms of the extremity of conditions"
4.22. It appears that a great deal of work still
needs to be done on the effect of nanomaterials in the gut. Dr Powell,
for example, said: "more work needs to be done in terms of
both nanoparticles and the larger nanoparticles or microparticles,
those larger than 100nm in diameter, in terms of what happens
inside the gut" (Q 215). Professor Depledge argued:
"the amount of evidence available with regard to the effects
of nanomaterials, delivered through food or in food, is very,
very small indeed and there is an urgent need to conduct more
studies" (Q 215). Other witnesses agreed (QQ 123,
232, 256). The EFSA stated: "the understanding of the potential
toxicity after oral intake of ENMs is in its infancy. Only a very
limited number of ENMs have been studied after oral administration
The ENMs used in the toxicity studies were often characterised
only to a very limited extent".
EFFECTS ON THE HUMAN FOETUS
4.23. When asked whether a human foetus might
be at risk from nanomaterials ingested by the pregnant mother,
the Research Councils told us that, although there was little
data available, "it
seems very unlikely that nanoparticles
can enter the foetus through simple diffusion unless they are
very small and simple molecules
It seems unlikely that
transport to the foetus can be completely prevented, but the concentration
of any nanoparticles will be substantially less than in the mother"
(p 220). The European Union SCENIHR report (see paragraph
4.2 above), however, noted that "distribution [of nanoparticles]
to the foetus in utero has also been observed" and
recommended that further research should be done in this area.
The EFSA also noted that "there is some information that
certain ENMs can pass across the placenta".
FOOD SPECIFIC RESEARCH
4.24. Evidence suggests also that more work needs
to be done on how the incorporation of nanoparticles into food
products might affect their subsequent behaviour both in the GI
tract and, once absorbed, in the body more generally. Professor Morris,
for example, said: "there is a need for specialised, directed
research on the interplay between food matrices and nanoparticles,
both in terms of the release and uptake of the nanoparticles themselves,
and also of the consequences of the adsorption of biologically-active
materials released from food
and their subsequent uptake
and transport within the body" (p 56). LFI took the
same view: "specific research within the food and drink model
is essential" (p 52).
4.25. Nanomaterials are carried to different
parts of the body by a mechanism which begins with their ingestion
by white blood cells which protect the body by ingesting harmful
foreign particles (phagocytic cells). These cells are equipped
with enzymes that have the capacity to degrade proteins and complex
carbohydrates. If a nanomaterial is non-biodegradable, these cells
will carry the particles to organs such as the spleen, liver and
bone marrow. Particles
will either remain in these organs or be transported on to organs
such as the brain and kidney. Understanding of the factors which
determine the pattern of the accumulation and distribution of
nanoparticles within the body is rudimentary (see Appendix 4).
In their Scientific Opinion, the EFSA said: "there is limited
information on the distribution pattern of ENMs after oral exposure"
and, further, "there are only limited data on potential,
long-term accumulation/persistence of ENMs".
CHRONIC EFFECTS OF NANOMATERIALS
4.26. In common with the risk assessment of many
substances, long-term, "chronic" effects are more difficult
to detect than immediate toxic impacts. Any chronic effects of
nanomaterials on the human body might take years to become manifest.
Professor Howard told us: "it is chronic long-term pathology
which may be rather more worrying than short-term toxicity"
(Q 284). A similar point is made by the SCENIHR report: "knowledge
of the long-term behaviour of nanoparticles is very limited, a
conservative estimate must assume that insoluble nanoparticles
may accumulate in secondary target organs during chronic exposure
with consequences not yet studied".
This concern was echoed by Professor Donaldson (Q 242).
The report recommended that more research should be undertaken.
VALIDATED TOXICOLOGICAL TESTS
4.27. Further work is also needed on the development
of new toxicological tests. Professor Depledge told us that
"there is a general consensus that conventional toxicology
testing is not very useful" (Q 258). The British Standards
Institute (BSI) highlighted the need for "suitable and validated
test and measurement methods developed through standardisation"
(p 224), a point also made by the NIA (pp 241-245) and
Dr Chaudhry (Q 270). Some work has been done: the United
Kingdom is taking part in an Organisation for Economic Co-operation
and Development (OECD) programme to develop toxicity tests for
14 nanomaterials (see paragraph 4.55), although Professor Depledge
thought that this work might be of "limited value" given
the "myriad of different forms" of nanomaterials (Q 258).
Filling the knowledge gaps
4.28. In 2004, the RS/RAEng report concluded
that, if nanotechnologies were to expand and nanomaterials become
commonplace, it was important that "research into health,
safety and environmental impacts keep pace with the predicted
A recent review of worldwide progress made on the Government's
19 research objectives (ROs) (see paragraph 4.15), EMERGNANO,
conducted by the Institute of Occupational Medicine in Edinburgh
and sponsored by DEFRA, found that, while progress has been made,
major gaps in the knowledge base remained: "in all of the
major thematic areas (characterisation, exposure, toxicology and
ecotoxicology), and all of the specific ROs, there is a substantial
[amount of] work remaining to be done. We conclude that the programme
of research activity has yet to develop step changes in the knowledge
base on these issues".
Lord Drayson acknowledged that more work was needed: "I recognise
that this area of technology is moving at a speed which is leading
to people's concerns. Thankfully there have been no safety issues
raised at present, but there is the sense
that there are
gaps in our knowledge" (Q 561).
RESEARCH CO-ORDINATION IN THE UK
4.29. Publicly-funded nanotechnologies research
in the United Kingdom is co-ordinated through the NRCG, a cross-departmental
group, chaired by DEFRA, which includes Government departments
and agencies, the Research Councils and devolved administrations.
Within the Research Councils, the RCUK Nanotechnology Group, under
the chairmanship of EPSRC, coordinates a cross-Council programme
on nanotechnologies (Q 385). Several Research Councils have
their own nanotechnology-related research programme, such as the
EPSRC's programme 'Nanoscience through engineering to application'
or the co-funded 'Environmental Nanoscience initiative' involving
the Natural Environment Research Council (NERC), DEFRA and the
Environment Agency (EA). As chairman of the Ministerial Group
on Nanotechnologies, Lord Drayson said that he was responsible
for ensuring that Government strategy on nanotechnologies, including
health and safety research, was carried out (QQ 553, 557).
4.30. Within this structure, responsibility for
fundamental research, which will underpin the development of effective
toxicological tests for risk assessment, lies with the Research
Councils. Dr Mulkeen explained: "We see the Research
Councils' primary responsibility as making sure that the fundamentals
of the generic science base that regulators need to work with
that could be applied to whatever products come out is well developed.
That is what people would look to the Research Councils to do
first and foremost" (Q 394). Once this fundamental research
has been done, Government departments and agencies have a responsibility
to fund any further research necessary to carry out their regulatory
role (Q 558). This might include, for example, ensuring that
the fundamental science is developed through to the production
of validated tests and methodologies for risk assessment. Gillian
Merron MP, Minister of State for Public Health, told us that
the FSA had a £22 million research budget for funding applied
research (Q 639). Dr Mulkeen emphasised the importance
of a "team approach" in which coordination bodies such
as the NRCG ensure that information about gaps in the basic science
required for regulation or safety assessment are fed back to the
Research Councils (Q 428), while Lord Drayson explained:
"if the FSA, for example, felt that there was a gap in fundamental
research which was needed to be filled to enable them to develop
an effective regulatory framework, then that is something which
would be taken into account by Research Councils, and therefore
the responsibility for the allocation of their funding made by
the Research Councils" (Q 560).
4.31. The RS/RAEng 2004 report concluded that
nanotechnologies posed a number of potential hazards to human
health and recommended that "the UK Research Councils assemble
an interdisciplinary centre
to undertake research into
the toxicity, epidemiology, persistence and bioaccumulation of
manufactured nanoparticles and nanotubes, to work on exposure
pathways and to develop measurement methods".
This research centre would "ensure that the understanding
of health, safety and environmental risks of nanoparticulates
keeps pace with developments in the field".
The Government did not adopt this recommendation and continued
to fund research into nanotechnologies through the established
channels of response-mode grants through Research Councils and
Government departments, coordinating its efforts through the NRCG.
4.32. When asked about the performance of the
NRCG in coordinating research into the health and safety aspects
of nanotechnologies, Lord Drayson said that "cross-cutting
research coordination across the Research Councils is of growing
I do not have any sense this is not working
well: quite the opposite" (Q 556). Mr John Roberts,
Head of Chemicals and Nanotechnologies at DEFRA, told us: "It
has taken a while to get momentum on the research, but it is true
to say that the research is now accelerating" (Q 18).
4.33. The 2007 report of the CST, however, pointed
to a "need for greater strategic cross-Government action
across different departments and agencies"
and concluded that in order to drive forward progress in this
field, a Government body should be given "responsibility
and power to allocate funds and instigate action" and that
Government must "embark upon an immediate programme of strategic
research spending in order to achieve the objectives identified
by the Nanotechnology Research Coordination Group".
The RCEP's 2008 report Novel Materials, also concluded
that "there is an urgent need for standardisation and co-ordination
of research effort and focus in this field [of nanotoxicology]".
Despite these comments, the Government appear to remain confident
about the role of the NRCG. Lord Drayson said: "Although
the Royal Commission argued for a more coordinated approach to
the direction of research, this is not something we are pursuing
at present" (Q 552).
4.34. We are less sanguine. Given the evidence
of continuing knowledge gaps about the effects of nanotechnologies
and also the concerns that have been raised about the coordination
of work in this area, we question whether NRCG is achieving its
purpose effectively. We note that the EMERGNANO report indicates
that, in areas where further research is needed, progress has
continued to be slow. For example, with regard to human health,
the EMERGNANO report states that "this review of ongoing
studies has failed to demonstrate that there is any comprehensive
attempt to gain the toxicokinetic
data required to reach
the aims of hazard identification" and there have been "no
systematic studies on the potential of different kinds of nanoparticles
to get into the blood, the lymph or the brain".
We find this conclusion worrying.
4.35. While the NRCG initially made good progress
in identifying areas where further work is needed, it has not
been so effective at ensuring that funding is allocated for research
projects which address these knowledge gaps. There appear to be
a number of reasons for this:
- The ineffectiveness of current
mechanisms employed by the Research Councils to promote research
in these areas;
- The relatively low amount of funding
allocated for health and safety research in the UK when set against
other research priorities;
- The limited capacity of the toxicology
research community to conceive and undertake the studies needed
to fill the knowledge gaps.
RESEARCH COUNCIL FUNDING MECHANISMS
4.36. Lord Drayson made clear that the Government
cannot dictate how the Research Councils allocate their funding:
"it is not for ministers to direct where research takes place
or which specific research projects should be funded [by the Research
Councils]" (Q 552). It is, therefore, the responsibility
of the Research Councils to ensure that research into knowledge
gaps in the fundamental research base, as identified by the NRCG,
is adequately funded.
4.37. This does not seem to have occurred. For
example, Research Objective 11 of the Government's 19 ROs is set
out as follows:
"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".
The MRC was assigned responsibility for RO 11.
Yet four years later the EMERGNANO progress report concluded that
largely un-researched area is ingestion as a route
Given the potential for this route to expose
very large numbers of individuals
the lack of activity
in this area is surprising".
We find this lack of progress extremely concerning.
4.38. The 2007 review by the CST concluded that
the primary reason for the Government's slow progress on health
and safety research was due "to an over-reliance by Government
on responsive mode funding, rather than on directed programmes
by Government departments to deliver the necessary research".
A number of witnesses supported this view. Professor Donaldson,
for example, told us:
"If we look at the Royal Academy/Royal Society
report, there was a really important paragraph that there should
be a central core-funded chunk of research and expertise brought
together to design a programme that would look systematically
at nanoparticle toxicology, and that was ignored. We had response
mode funding where people just put forward what they wanted to
do, so what you get is piecemeal" (Q 267).
Professor Jones also alluded to the relative
strength of research investigating nanoparticle toxicology in
the lung compared to a lack of research into the gut as a result
of response-mode funding (Q 494).
4.39. In response to the CST review, since March
2007, the Research Councils have been actively promoting proposals
in areas related to nanotoxicology and safety (Q 388), and
have issued a "highlight notice" for nanotoxicology
which specifies the research areas where they would like to attract
proposals (Q 411). As a result, the MRC has committed £3
million to six projects looking at nanotoxicology.
4.40. None of these projects, however, is food-related
(QQ 402, 413) and the MRC recognised this as a deficiency.
Dr Mulkeen told us: "From the MRC's point of view we
are generally happy with the progress we have made since we put
out the highlight notice and started promoting application of
this in this area more actively in March 2007
I would concede is that the response has not included enough gut
work" (Q 396). Dr Mulkeen said also that the MRC
was funding only one research group working on nanomaterial toxicology
in the gut, and even
that group was working on safety only in part (QQ 397-398).
4.41. While we welcome the efforts that have
been made to encourage the submission of applications in nanotoxicology
as a whole, the slow rate of progress in areas such as the gut
suggests that the Research Councils have not put a high enough
priority on ensuring that projects covering the range of research
objectives identified by the NRCG are encouraged and funded. Dr Mulkeen
told us that in summer 2009 the Research Councils intended to
"put out a new statement to the community of what we now
think the deficiencies are and what the next step of gaps that
we want to see addressed are" (Q 402). We understand
that this statement has been delayed so the MRC can consider the
recommendations of this report, and of EMERGNANO, when determining
4.42. We are disappointed and concerned that
the Research Councils have not adopted a more pro-active approach
to encourage and stimulate research bids in areas where existing
mechanisms have so far proved ineffective. Dr Mulkeen told
us that the MRC would take "more active steps if needed"
to develop research into the safety of nanotechnologies (Q 420).
We feel that a more pro-active stance is essential given the lack
of progress in several key areas to date.
4.43. We recommend that the Research Councils
should establish more pro-active forms of funding to encourage
the submission of research bids to address the severe shortfalls
in research required for risk assessment of nanomaterials as set
out in the EMERGNANO report, and ensure that submissions are reviewed
by a committee with appropriate expertise in this field.
4.44. We further recommend that, as part of
any strategy to address the research shortfalls identified in
the EMERGNANO report, the Government should ensure that specific
research is focused on the gut and the other knowledge gaps we
have identified above (paragraphs 4.18-4.27) with relevance to
the risk assessment of nanomaterials in food or food contact materials.
4.45. We are aware that the FSA intends to commission
research into "the fate of nanomaterials in the gut"
(Q 635) and we welcome this development. We felt it was regrettable,
and surprising, that the FSA, when giving evidence, was unwilling
to tell us how many applications had been received in response
to the call for the work (Q 641, p 290). This is unnecessary
and inappropriate secrecy.
FUNDING FOR ENVIRONMENTAL, HEALTH AND SAFETY RESEARCH
4.46. The total public spending in the United
Kingdom on human health and safety research into nanotechnologies
is unclear. The NRCG report, Characterising the Potential Risks
posed by Engineered Nanoparticles: A Second UK Government Research
Report, published in 2007, stated that Government departments
and agencies spent £10 million on Environmental, Health and
Safety (EHS)-related research into nanotechnologies in 2005 to
2008, which was additional to research in this area funded by
the Research Councils.
We asked DEFRA how much the United Kingdom had spent on health
and safety research into nanotechnologies. Their response, based
on the EMERGNANO report, said that United Kingdom spending on
nanotechnologies EHS research over the period 2004 to 2008 was
£3.3 million, compared to £63 million within the European
Union, and £37
million in the United States (p 47). The EMERGNANO report
does not, however, include any MRC-funded projects in the United
Kingdom figurewhich is surprising given that the MRC told
us they spent £3.8 million on research into nanotechnology
(including nanotoxicology) in 2007-08 alone (p 202). As regards
spending in the United States, the US National Nanotechnology
Initiative states that EHS funding was $35 million in 2005 and
$68 million in 2006substantially
more than the figures DEFRA supplied to us based on the EMERGNANO
4.47. In its response to the 2004 RS/RAEng report,
the Government made a commitment to funding independent reviews
of its progress against the actions set out in the report after
two and five years.
The CST report in 2007 was the first; the second is due to be
commissioned shortly. In order to assist the second review, we
believe that there needs to be greater clarity about spending
on EHS research in this area.
4.48. We therefore recommend that the Government
ensure that a breakdown of annual public spending on nanotechnology-related
environmental, health and safety research within the United Kingdom
is compiled and available when the five-year review of its progress
against the 2004 Royal Society and Royal Academy of Engineering
report is carried out.
4.49. Although the figures vary, what is clear
is that spending on EHS research is a small proportion of overall
spending on other areas of nanotechnologies developmentthe
EPSRC alone spent £220 million on nanotechnologies research
in the last five years (see paragraph 3.28). Professor Depledge
told us the amount of money for health and safety research is
"tiny" in comparison to the amount "invested in
the development of new nanotechnologies" (Q 260). The
2007 CST report supported a recommendation in the RS/RAEng report
that a minimum of £5-6 million a year, over 10 years, should
be spent on researching toxicology, health and environmental effects
Current EHS spending clearly falls short of this target.
CAPACITY OF THE TOXICOLOGICAL COMMUNITY
4.50. A number of witnesses expressed concern
about the capacity of toxicologists in the United Kingdom to carry
out the volume of work required. Dr Wadge, for example,
said that there needed to be a considerable quantity of research
undertaken in the area of nanotechnologies and the food sector
and that this raised "bigger, wider questions about whether
we have the appropriate capacity of toxicologists within the UK"
(Q 29), a concern echoed by Dr Mulkeen (Q 389).
In response to the 2007 CST review, Malcolm Wicks MP, then
Minister of State for Science and Innovation, stated that the
uptake of response-mode funding for research into the health implications
of nanotechnologies was disappointing, but that "the problem
is not that funding is not available. Rather, it is that the community
of toxicologists in the UK is small and has not been submitting
The 2008 report of the RCEP also concluded that there was an urgent
requirement for trained toxicologists to take on the challenges
of nanotechnologies and recommended that "more attention
is given to toxicology training in our higher education institutes"
to increase the number of qualified individuals.
4.51. In 2009, the Government published a report
(commissioned by DEFRA) entitled An Evaluation of the UK Skills
Base for Toxicologists and Ecotoxicologists. It stated clearly:
"there are not enough scientists to meet the predicted future
The report recommended recruiting new staff and investing in the
training of existing scientists. Lord Drayson indicated that he
was aware of the problem:
"we are looking actively now at how we can most
effectively influence students to participate in those courses
for which there are skills gaps, where there are clear needs
which are needed for national priorities and research. I hope
that we are able to come forward with some new policies addressing
this issue over this year" (Q 568).
4.52. We endorse the recommendation contained
in the 2008 report of the Royal Commission on Environmental Pollution
that more attention should be paid to toxicology training. We
welcome, therefore, the Government's commitment to tackling the
shortage of trained toxicologists and ecotoxicologists and also
their commissioning of an evaluation of the United Kingdom skills
base for toxicologists and ecotoxicologists. However, the policies
to address the shortfall promised for this year have not yet been
launched. We look for urgent progress on this issue and ask that
the Government update the Committee on its activity in this area.
4.53. A number of witnesses commented on the
importance of international coordination of health and safety
research into nanotechnologies (Q 111). As Mr Roberts
told us, "the issue is global; there is a lot of experience
in other countries and we can get much better results if we coordinate
our research programmes" (Q 18).
4.54. Support for increased international cooperation
on information-sharing and driving forward a shared research agenda
appears strong. In 2008, for example, the Intergovernmental Forum
on Chemical Safety issued the 'Dakar Statement on Manufactured
Nanomaterials' which recommended that governments should increase
their efforts to fill knowledge gaps, promote information sharing
and "develop, fund, and share effective research strategies
on potential risks to human health and the environment"
Yet the 2009 EMERGNANO report concluded that "while many
[national and international] agencies and organisations
have developed and published research strategies, and although
attempts are being now made to link up
until now there
has been little effective international co-ordination on research
activity. As a result, funded projects are unlikely to provide
coherent or comprehensive coverage of the issues".
4.55. A forum where international coordination
is already taking place is the OECD. Dr Wadge told us that
"probably what is most important from a scientific point
of view is that we have international agreement on the risk assessment
procedures and that is where the OECD work has a really important
part to play" (Q 54). 14 of the most commonly used nanoparticles
have been shared out among member states in the OECD for analysis.
The UK is taking forward the characterisation and testing of two:
cerium oxide and zinc oxide (Q 18). Yet questions have been
raised about the OECD's relatively restricted membership, a lack
of transparency and limited stakeholder involvement. Friends of
the Earth Australia was concerned about the OECD's role as a vehicle
for communication about risk research and policy responses, given
that "a lot of the world is not represented in OECD, and
a lot of the OECD's communication is happening exclusively in
English" (Q 304). A 2009 Chatham House report by Dr Falkner,
Senior Lecturer in International Relations at the London School
of Economics, Securing the Promise of Nanotechnologies,
stated that outsiders not directly involved with the process
often find it difficult to follow the progress of work, and that
the complex process of declassifying reports from its working
parties can cause significant delays in publication. It concluded
that it was "desirable for the nanotechnology working parties'
inclusiveness and transparency to be enhanced in order to facilitate
broader participation and openness" although it acknowledged
that this would be difficult to accomplish given the OECD's existing
these concerns, we recognise that at the present time the OECD
has a central role to play in the coordination of research efforts
for the development of test methodologies for risk assessment
which will underpin the regulation of nanotechnologies.
4.56. The International Organization for Standardization
(ISO) has an important role to play in developing standards for
nanotechnologies, including definitions, which are likely to feed
directly into national and international regulatory developments
(p 179). Other examples of coordination include the Environmental
Nanoscience Initiative, set up by NERC, DEFRA and the EA. The
Initiative is moving into its second phase in cooperation with
the EPAin the United States which is providing almost half of
the £4.5 million funding (Q 18).
4.57. The European Union has provided 40
million in funding for nanomaterials safety research in the last
three years, along with another 10 million in 2009 (Q 594).
The research that the European Commission funds is coordinated
through Programme Committees, where the United Kingdom is represented,
as well as through more informal consultations between Commission
Directorates and Member States (Q 596). Ms Merron told us
that the FSA's research programmes "take account of relevant
research in Europe and the wider international context" and
that the FSA can provide co-funding for "European projects
where these align with our priorities" (p 290). For
example, the FSA is contributing to a three-year European Union
project which will be examining methods of measuring nanomaterials
in food (Q 635). In addition, the FSA is a partner in the
European project SAFEFOODERA, which "aims to co-ordinate
national research in food safety across some 19 European countries".
This project has recently issued two jointly funded research calls
4.58. Whilst we welcome the collaboration that
is taking place, more could usefully be done. In particular, we
are not convinced that the Research Councils are making the necessary
efforts to coordinate their research into the health and safety
implications of nanotechnologies with other EU member states.
We asked the Research Councils how they coordinated their work
in an EU and international context: they informed us of the work
of the OECD (see paragraph 4.55 above) but made no reference to
any form of systematic coordination or collaboration with other
EU Member States (Q 433). When asked the same question, Lord
Drayson told us that "a significant proportion of research
which is funded by research communities is of proposals which
are international collaborations or research groups across both
Europe and with the United States", but acknowledged that
"it is not perfect" (Q 575). He added: "I
do believe that ensuring there is better coordination internationally
of the understanding of research priorities is an area where more
work needs to be done" (Q 575).
4.59. Regulatory agencies within other Member
States will be regulating the same products, under laws implementing
the same EU legislation, within the single market. There are opportunities
for research to be further coordinated and targeted to share the
burden of work and to avoid unnecessary duplication of effort.
Research funders in the United Kingdom should work towards not
simply the joint funding of research projects with other nations,
but coherent strategies that ensure research agendas are aligned
towards common goals and priorities where appropriate.
4.60. We recommend that the Government work
more closely with other EU Member States on research related to
the health and safety risks of nanomaterials to ensure that knowledge
gaps are quickly filled without duplication of effort, while continuing
to support coordinated research in this area at an international
level through appropriate international organisations including
the International Organization for Standardization and Organisation
for Economic Cooperation and Development.
THE ROLE OF INDUSTRY
4.61. Dr Knowles told us that industry had
a role to play in funding some aspects of health and safety research:
"I ... agree 100 per cent with you that it [research in the
gut] has to be funded by both industry and the Government"
(Q 170). However, he noted that, at the moment, it was the
chemical and pharmacological industries, rather than the food
industry, which was funding most of research into the basic toxicology
of nanomaterials (Q 170).
4.62. Dr Knowles talked about cooperation
between the food industry, academia and the EU on "pre-competitive
research" concerning the nature of nanomaterials rather than
on possible applications in food which companies would view as
commercial research. He told us that food companies are collaborating
with the EFSA, looking at "how one should organise the research
that you are talking about in terms of in vivo ingestion
of these materials as opposed to inhalation". He also told
us of coordination that is taking place between industry and academia,
and gave as an example a joint project with the Dutch Public Health
Service on the measurement of nanomaterials in food matrices.
He added that he hoped eventually it would be "translated
into a major, multicentre project", funded half by the European
Commission and half by industry (Q 207). Another example
is Nanocare, a collaborative project in Germany bringing together
representatives from industry, Government and academia. It will
be looking at, among other areas, the publication of data on the
known and unknown impact of nanomaterials on the environment and
health, as well as a "combination of industrial manufacturing
and toxicity research" (p 17).
4.63. Professor Jones told us that, in the
United Kingdom, the TSB is "putting together industry consortia
to do research, both in bringing research to market and in dealing
with toxicological and eco-toxicological issues" (Q 492).
The TSB's main instrument for promoting research in health and
safety issues is the SAFENANO project, a website run by the Institute
of Occupational Medicine and funded by the TSB, initially for
three years, which aims to provide impartial and independent information
to stakeholders on potential health and safety risks from nanomaterials.
The project has the remit to collect, interpret and disseminate
emerging scientific evidence on these issues.
Professor Jones said that industry had contributed to this
project, in particular "the NIA has been active
identifying the research needs of NIA members and feeding into
the TSB" (Q 492). We commend this initiative.
4.64. Lord Drayson confirmed to us that there
is no central database for health and safety data from academia,
industry and Government in the United Kingdom, although the OECD's
Working Party on Manufactured Nanomaterials has recently launched
a database of global research conducted into the safety of nanomaterials
(p 271). While we welcome the creation of an international
database, we can also see a need for further sharing of information
at a national level between industry and government.
4.65. We asked Dr Knowles whether companies
would share information about the safety-testing of new products
before they were released on to the market. He thought that they
would not, although the information would become publicly available
when health and safety-testing information was submitted to the
EFSA for pre-market risk assessment purposes. (QQ 208-209).
We asked whether he felt commercial confidentiality was an inhibition
on the effective sharing of safety information: "At the time
when it is commercialised, no, the safety information is circulated"
(Q 210). On the other hand, the Royal Society suggested that
a reluctance by industry to share proprietary information could
delay the implementation of necessary regulatory controls and
pointed to the example of the cosmetics sector, where "attempts
to assess methods [of risk assessment] have been hampered by industry
reluctance to provide the SCCP [European Commission's Scientific
Committee on Consumer Products] with information on the use of
nanoparticles and methods employed for their risk assessment"
(p 364). Professor Owen told us that there is "insufficient
co-ordinated research and
inadequate governance processes"
to ensure that information about nanomaterials used by industry
is "presented in a timely way" (Q 446). Dr Wadge
also felt that "commercial pressures" would make companies
unwilling to talk about technical developments in public fora
4.66. We recognise that the industry wishes to
protect sensitive commercial information, yet industry also has
a great deal to gain from cooperating with Government to share
information about health and safety data and other information
that regulators can use to inform the development of risk assessment
procedures and help regulation keep pace with technical developments
in the science. Mr Trevor Maynard, Emerging Risks Manager
at Lloyd's, told us that a database of information on nanomaterials
used by industry would "assist in the process of
assessment" (Q 445), while Ms Merron told us that Government
had to work with industry to "make them realise that it is
in their interests" to share information with the Government
(Q 649). Yet past attempts at voluntary reporting schemes
to build up a database of information on nanomaterials used by
industry have often been ineffective.
4.67. DEFRA has run a voluntary reporting scheme
for nanomaterials since September 2006 which aimed to obtain information
from companies about what difficulties they were experiencing
and "what research priorities might need to be addressed"
(Q 580). Response to the scheme has been "disappointing"
(Q 582) because, Mr Roberts told us, "there is
between industry's desire for confidentiality
of new developments and our interest in knowing what they are
doing" (Q 39). Dr Friedrichs said that this was
due to the complicated and extensive nature of the information
requested (Q 508), but Lord Drayson, Minister for Science,
defended the scheme: "these are issues of some complexity
and therefore require considerable information from the companies
concerned" (Q 582). Lord Drayson said that he planned
to take into account feedback from the industry when deciding
how to develop the scheme but warned: "I have to say really
quite clearly that I do expect industry to respond effectively.
It is not good enough to see this level of response" (Q 582).
4.68. In 2008, in the United States, a Nanoscale
Materials Stewardship Program was launched by the EPA "to
help provide a firmer scientific foundation for regulatory decisions"
by encouraging companies to submit information about the nanomaterials
they were working on.
The response rate to this scheme was also disappointing and the
EPA said that they were now considering a mandatory scheme (see
Appendix 6). Other countries are also considering moving to mandatory
reporting schemes. For example, Canada has announced a mandatory
register of nanomaterials which will include information on safety
data. France has announced its intention to consider a similar
scheme (Q 303).
4.69. Dr Falkner argued for a mandatory
reporting scheme on the basis that it would "level the playing
field" and avoid the dangers of a voluntary scheme in which
companies that are transparent and which provide information might
be placed at a commercial disadvantage (Q 343). Ms Davies
suggested that the poor response to the DEFRA scheme indicated
that any scheme would have to be mandatory in order to ensure
a useful level of participation from industry (Q 299). Ms
Miller and Mr Maynard agreed (QQ 302, 446). Professor Nick
Pidgeon, Professor of Environmental Psychology at Cardiff
University, told us that, when considering public confidence
in a technology, "people are very suspicious that industry
will not voluntarily report, so that would be the benefit of a
mandatory system" (Q 376).
4.70. Some witnesses, including Professor Derek Burke,
former Chair of the Advisory Committee on Novel Foods and Processes,
(Q 332) and Dr Friedrichs, favoured a voluntary register
to ensure that it was "inclusive rather than exclusive"
(Q 507). Ms Merron said that she would prefer a voluntary
scheme and one which was not too onerous for industry (Q 649).
4.71. Lord Drayson's view was that: "A perfect
scheme would be one which had the full support and engagement
of industry on a voluntary basis and provided us with sufficient
information on what the individual companies were doing to enable
us to feel we had a firm handle on the development and potential
application of these technologies in future products" (Q 582).
Lord Drayson recognised however that this was an ideal which was
unlikely to occur (Q 584).
4.72. We recommend that the Food Standards
Agency develop, in collaboration with the food industry, a confidential
database of information about nanomaterials being researched within
the food sector to inform the development of appropriate risk
assessment procedures, and to aid in the prioritisation of appropriate
research. Industry participation in this database should be mandatory,
given the failure of similar voluntary schemes in the United Kingdom
12 Donaldson K et al., "Carbon nanotubes introduced
into the abdominal cavity of mice show asbestos-like pathology
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Song Y et al., "Exposure to nanoparticles related to plural
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SCENIHR (Scientific Committee on Emerging and Newly Identified
Health Risks), Risk assessment of products of nanotechnologies,
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Dobrovolskaia MA et al., "Preclinical studies to understand
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Scientific Opinion of the Scientific Committee of the European
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para 4.3.5. Back
Committees on Toxicity, Mutagenicity and Carcinogenicity of Chemicals
in Food, Consumer Products and the Environment (COT,COM, COC),
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para 9. Back
Handy RD et al., "Manufactured nanoparticles: their uptake and effects on fish--a mechanistic analysis",
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Ramsden CS et al., "Dietary exposure to titanium dioxide nanoparticles in rainbow trout, (Oncorhynchus mykiss): no effect on growth, but subtle biochemical disturbances in the brain",
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Mann S, "Self-assembly and transformation of hybrid nano-objects
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Council for Science and Technology (CST), Nanosciences and
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Policy Commitments, 2007, p 15, para 36. Back
Ibid, CST, Review of the Government's Progress,
p 5. Back
Royal Commission on Environmental Pollution (RCEP), Novel Materials
in the Environment: The case of nanotechnology, 2008, p 76,
para 5.3. Back
When we use the term the 'gut' we refer to the gastro-intestinal
EFSA, Scientific Opinion, op. cit., p 22, para 4.4.5. Back
SCENIHR, Risk assessment of the products of nanotechnologies,
op. cit., p 29, para 220.127.116.11. Back
EFSA, Scientific Opinion, op. cit., p 18, para 4.3.5. Back
Sadauskas E et al., "Kupffer cells are central in the removal of nanoparticles from the organism",
Particle and Fibre Toxicology, 2007, 4 (10). Back
Aitken RJ et al., EMERGNANO: A review of completed and near
completed environment, health and safety research on nanomaterials
and nanotechnology, Report for DEFRA, 2009, pp 156-157. Back
EFSA, Scientific Opinion, op. cit., p 16, para 4.3.2. Back
Ibid., EFSA, Scientific Opinion, p 18, para
SCENIHR, Risk assessment of products of nanotechnologies,
op. cit., p 29, para 18.104.22.168. Back
RS/RAEng Nanoscience and nanotechnologies, op. cit., p
50, para 64. Back
Aitken et al., EMERGNANO, op. cit., p 157. Back
RS/RAEng Nanoscience and nanotechnologies, op. cit.,
p x, para 26. Back
Ibid., RS/RAEng, Nanoscience and nanotechnologies,
p 81, para 13. Back
CST, Review of the Government's Progress, op. cit.,
p 7, para I. Back
Ibid., CST, Review of the Government's Progress,
p 7. Back
RCEP, Novel Materials, op. cit., p 55, para 3.120. Back
Aitken et al., EMERGNANO, op., cit., p 115. Back
Characterising the potential risks posed by engineered nanoparticles:
A first UK Government research report, 2005, p 29. Back
the potential risks, p 41. Back
Aitken et al., EMERGNANO, op. cit., p 128. Back
CST, A review of the Government's Progress, op.
cit., p 16, para 43. Back
Dr Jonathan Powell's team at the MRC Collaborative Centre for
Human Nutrition Research. Back
DEFRA, Characterising the Potential Risks posed by Engineered
Nanoparticles: A Second UK Government Research Report, 2007,
p i. Back
The European Union figure includes spending by the United Kingdom. Back
See http://www.nano.gov/html/society/EHS.html Back
UK Government response to the Royal Society and Royal Academy
of Engineering Report "Nanoscience and Nanotechnologies:
opportunities and uncertainties", 2005. Back
CST, A Review of the Government's Progress, op.cit.,
p 15, para 42. Back
Letter from Malcolm Wicks MP, Minister of State for Science and
Innovation to Sir John Beringer CBE, Council for Science and Technology,
17 May 2007, p 5. Back
RCEP, Novel Materials, op. cit., p 55, para 3.121. Back
Handy RD et al., An Evaluation of the UK Skills Base for Toxicologists
and Ecotoxicologists, with Focus on Current and Future Requirements,
Particularly with Regard to the Skills Required for Hazard Assessment
of Chemical Substances including Nanomaterials, Report for
DEFRA, 2009, p 4. Back
See http://www.who.int/ifcs/documents/forums/forum6/f6_execsumm_en.doc Back
Aitken et al., EMERGNANO, op. cit., p 3. Back
Falkner R et al., Securing the Promise of Nanotechnologies:
Towards Transatlantic Regulatory Cooperation, 2009, p 87. Back
See http://www.safenano.org/Uploads/SAFENANO_AUG21.pdf Back
EPA, Nanoscale Materials Stewardship Program: Interim Report,
2009, p 3. Back