Examination of Witnesses (Questions 280
- 299)
TUESDAY 2 JUNE 2009
Ms Sue Davies, Professor Vyvyan Howard and Ms Georgia
Miller
Q280 Chairman:
Thank you very much. Georgia, would you like to introduce yourself?
Ms Miller: Thank you. My name is Georgia Miller.
I have coordinated Friends of the Earth Australia's nanotechnology
project since 2005 and the application of nanotechnology in food
and agriculture is something we are very much interested in. Last
year I was one of the two primary authors of an international
Friends of the Earth report in relation to nanotechnology in food
and agriculture. I guess that there are four key things that I
am hoping we can talk about in this session. The first is really
the scope and I want to suggest that we are looking at more than
a question of food safety, we are actually looking at quite a
broad issue of food policy. The second is the need for precautionary
management given how little we know both about risks and also
how to assess those risks. The third is the need to really critically
assess claimed benefits because I want to suggest that many of
these benefits actually come with significant costs. The fourth
is the need for public involvement in decision making which I
understand will be addressed in some of the questions later.
Q281 Chairman:
Thank you very much. That is a very helpful introduction from
all of our witnesses. I would now like to kick off with opening
the questioning myself and I would like to ask each of the witnesses
what you feel are the potential benefits as well as the risks
related to nanotechnologies and nanomaterials in food, either
in food itself or in relation to packaging. You have all expressed
views about this in your evidence but I would like to hear now
a summary of your position.
Ms Davies: I think one of the difficult issues
in this area is that it is hard to get a sense of exactly what
is happening now and what could be happening in the future in
order to determine whether or not there are products that are
going to offer real consumer benefits. From looking at some of
the discussions in the scientific press and some of the food technology
literature it seems that there is a lot of potential for things
like improved nutritional characteristics, improved sensory qualities,
potentially less waste in terms of improved packaging, better
food safety; there are a whole range of potential benefits that
could be offered by nanotechnologies. However, our concern is
that it is quite difficult to work out exactly what we are going
to be seeing and over what timescale. It would be nice to have
a clear idea of what is on the market now and have a sense of
what is going to be here in five years, ten years, 20 years and
what kind of issues are those going to raise. We do think that
it seems there are going to be some genuine benefits but we also
think there needs to be a more proactive approach to actually
make sure that the investment is really going into tackling the
problems we are facing in terms of food policy. How can nanotechnology
be used to help tackle obesity and diet-related disease, improve
food safety, reduce the environmental impact of food production?
There is not really enough transparency or enough open discussion
at the moment about what is being done and what could come along.
If you look at the Nanoshop website or you look at the Woodrow
Wilson website, which seems to be the main source of information
about nanofoods, most of the developments to start with are in
the food supplement area which are making claims about improved
bioavailability or absorption of nutrients, or packaging materials
(EFSA has already approved one type of packaging material, for
example). That seems to be where the main interest is at the moment
and it seems that there could be benefits, certainly in the case
of packaging materials, but we are concerned that we want to make
sure that these are genuine benefits and that consumers, as Georgia
said, are not being duped into buying things at the moment that
are not really offering any benefits beyond conventional products
and paying more for it. Of course this all needs to be balanced
against the risks. Do you want to come on to the discussion about
the risks now?
Q282 Chairman:
If you could briefly way what you think the main issues are about
risk then we will cover it in a bit more detail later.
Ms Davies: The interesting thing in this area
is that the people who are really excited about this technology
are also really open about the fact that there is an awful lot
that we do not know about it at the moment; precisely the reason
why nanotechnologies are going to offer lots of new benefits because
of the change in properties of materials could also bring new
risks that we do not fully understand. The recent EFSA opinion
on this, for example, highlights that there are some really key
knowledge gaps in different areas that need to be addressed urgently.
We think that we need to have a clearer sense of what products
are coming along so that we can get a sense of what are the benefits
and what will be really useful for consumers, but also we need
to get a sense of what is being developed now so that we can properly
understand what kind of risks they could be posing and make sure
that we have adequate regulation in place as well.
Q283 Chairman:
Thank you. Professor Howard?
Professor Howard: I want to highlight some of
the knowledge gaps and areas of potential hazard. Under Framework
Seven of the EU Programme there are 1.4 billion euros earmarked
for nanotechnology but every project must have a safety aspect
to it. The two grants that we have so far total 5.7 million euros.
There are also targeted funds from research councils in the UK
so there is certainly an awareness that we need to know more.
Indeed I and other colleagues around the world are trying to do
that. There are two basic questions. One is, if you have a nano-product—a
particle in a food substance—where does it get to and how
long does it stay there? That is question number one and in a
way that is one of the easier questions to address. The second
question is, does it matter if it does get there and stay there
that long? That is actually much more difficult to appraise. I
think we have to think about the nature of food. If you consider
how much we spend on doing toxicological testing of pharmaceuticals
and agro-chemicals, where we might expect to be exposed over a
lifetime to micrograms or milligrams, our consumption of food
is measured in tons over a lifetime. So the potential dosage is
extremely high and I think that does mean that we have to take
a precautionary stand. The main area that I am worried about is
that if you nanonise materials into mobile nanoparticles they
become more mobile within the body. The reason for that is that
there are processes going on in the cell walls which are continuous
and it is the way that viruses get round it, it is a process called
endocytosis. There are quite a few studies on this—Wolfgang
Kreyling has done a lot of work in this field—which show
that if you do expose animals or humans to nanoparticles they
will travel and they will get across places like the blood-brain
barrier where we have evolved methods of keeping out molecules
that we do not want. So they can act as a sort of "Trojan
horse". Which particular spectrum of disease do we need to
think about most? Well, there are a series of diseases called
protein misfolding diseases. Most of them occur in the central
nervous system; there are 42 known in humans currently (including
Alzheimer's, Parkinson's disease, spongiform encephalopathy).
Nerve cells cannot reproduce themselves; they have to internalise
any misfolded protein that is insoluble and some of these fragments
can be toxic. The worry would be that if we are exposing ourselves
to large doses of nanomaterials and they are able to get into
areas like the brain, they might be able to increase the rate
of protein misfolding and that is what our second grant is all
about. We are actually studying that now.
Q284 Chairman:
I wonder, because we are short of time, if you could keep it pretty
succinct. We can always follow up with more detailed supplementary
evidence.
Professor Howard: I think that is the main point
I want to make, that it is chronic long-term pathology which may
be rather more worrying than short-term toxicity.
Q285 Chairman:
What about potential benefits? Do you see any benefits?
Professor Howard: I think Sue has already mentioned
those: a cut in waste, a cut in bacterial contamination; those
sorts of things.
Q286 Chairman:
Georgia, would you like to comment on the potential benefits and
risks?
Ms Miller: Vyvyan has just talked in some detail
about potential risks and I saw the excellent presentation that
the nanotoxicologists made to you a month ago, so I do not want
to talk in great detail about the risks. I do want to observe
that the uncertainties around nanocharacterisation and risk assessment
are so great that experts anticipate that it will take us years
before we can actually do a validated risk assessment, that is
until we know the right questions to ask, the right tests to do.
I find this very concerning so that is one thing I do want to
draw to your attention. I guess the other thing that I am concerned
about is the size definition. Again I heard a recurring theme
when the nanotoxicologists gave evidence to you a month ago that
100 nanometers really does not capture biologically relevant nanoparticles
that may be 200 or 300 nanometers in size, so I think that is
something we are also concerned about. In relation to the so-called
benefits, I really want to challenge the notion that widespread
use of antibacterials, for example in packaging, will deliver
socially useful outcomes. This is for a couple of reasons. We
are very concerned that widespread use of potent antibacterials
in the form of nanomaterials could actually cause a lot of unanticipated
problems. We are already suffering massive problems with bacterial
resistance to antibiotics in a medical setting. There is some
emerging evidence that use of silver in a medical setting is also
being met with resistance. What are the implications of the widespread
use of nano-antibacterials in food packaging, in refrigerators,
in storage containers, as well as in socks and computer keyboards
and dishwashers et cetera? I think there are some very real challenges
here that we need to deal with. While we do not think any illness
as a result of food contamination is ever acceptable, I emphasise
that in the UK there is 50 times greater illness as a result of
poor diet than as a result of safety problems. I think we need
to ask: will nanotechnology as a whole result, for example, in
greater consumption of highly processed food and less consumption
of fruit and vegetables? Will the addition of nano-additives to
junk foods enable them to be marketed for health values, for example
increased nano-encapsulated omega-3 or iron fortification? Will
this perhaps further confuse people and lead to a further loss
in terms of people's diet choices? If the answers to those things
are "Yes" then it is possible that nano will actually
result in poorer health outcomes. I do think we need to query
a lot of these claimed benefits, really interrogate them, rather
than just accepting them at face value.
Q287 Chairman:
Thank you very much. I just want to ask one supplementary question
here. I think that Friends of the Earth Australia as well as the
Soil Association are calling for a moratorium on the sale of nano-foods
whereas I think Which? has not called for a moratorium. I wonder
if Sue could indicate from the point of view of Which? why you
do not think a moratorium is necessary, and then I will ask Vyvyan
and Georgia briefly to say why they think a moratorium is necessary.
Ms Davies: I suppose our focus has been much
more on understanding what developments are taking place and could
be taking place, making sure that we have an effective regulatory
framework in place, making sure that nanomaterials have to be
approved before they come to market and that we have enough research
to enable effective risk assessment to be able to carry that out.
We do not really think that a moratorium is very meaningful. We
have issues around definition, it is very difficult to find out
what is actually happening, so even if we thought that a moratorium
was useful we do not understand how it would practically be enforced
and applied.
Q288 Chairman:
Professor Howard, could you briefly indicate why you think a moratorium
is necessary?
Professor Howard: Data gaps have already been
mentioned and we find it very difficult to construct a meaningful
risk assessment given the level of data gaps that we have in most
areas of nanoparticle fate and toxicity. Given the potential dose
that people would be receiving in food, the Soil Association has
come to the conclusion that they would prefer to see a hold on
development while some form of risk assessment can be developed.
Q289 Chairman:
Would that apply to naturally occurring as well as engineered
nanoparticles?
Professor Howard: I think that applies mainly
to engineered nanoparticles, things that we have not encountered
hitherto during our evolutionary history.
Q290 Chairman:
Georgia, very briefly, reading the evidence from Friends of the
Earth Australia, you wish to broaden the definition of nanotechnologies
in food to include both engineered and naturally occurring nanoparticles.
That is as I understand it; is that correct or not?
Ms Miller: No, that is not correct. What we
have suggested in terms of broadening the definition is that we
consider, for the purposes of health and safety assessment, particles
up to 300 nanometers in size as nanoparticles and I believe there
is good reason given the evidence that a number of particles that
are around 200 nanometers or so in size are still, for example,
showing protein binding characteristics that Vyvyan referred to
earlier as a cause for concern. We have focused specifically on
the issue of manufactured nanoparticles and manufactured nano-additives
to food. We do highlight the issue of nanoparticles which are
in a sense a by-product of contemporary high intensity processing
technologies as an area which does warrant further investigation,
but we have not called for a moratorium to extend to those sorts
of nanoparticles.
Q291 Lord Haskel:
Of course our relationship with the European Union is very important
and central to this. The European Parliament has proposed that
when the Novel Foods regulation is revised it should explicitly
apply to all nanomaterials; it does not differentiate. Do you
think the government should accept this advice?
Ms Davies: We think that a distinction does
need to be made between manufactured nanomaterials and the types
of nanomaterials that have been traditionally used and may use
nanotechnology, so things like custard or mayonnaise for example
that have been around, not to say that these are inevitably risk
free. We think that manufactured nanomaterials should be the focus
of the Novel Foods regulation. We think that the definition that
was proposed by the European Parliament which talks about in the
order of one to 100 nanometers is probably quite useful but you
need to be careful about being too strict about definitions because
there is still an awful lot that we do not understand and some
people are asking whether we should be talking of up to 300 nanometers
for example and the surface area is obviously a crucial aspect
and how do you take that into account. The proposal from the Commission
takes into account the advice from the European Food Safety Authority.
We think it should be focused on the manufactured nanomaterials
but it is also important to look at other pieces of regulation
as well as the Novel Foods regulation to make sure that they are
fit for purpose as well. The European Commission has said that
it feels that under the food additives legislation, for example,
if something was in nano form it would have to be reassessed and,
even if its conventional form had already been approved, it would
have to be resubmitted and approved again. Similarly with food
supplements, if you are using vitamins and minerals in a nano
form they would have to be submitted. There is a lack of clarity
in the regulations and with the associated guidance that all needs
sorting out at the moment and we are concerned, about how you
can you be sure that people who are potentially looking at producing
these types of products actually understand what applies to them
and what route they need to go through, and whether the enforcement
people on the ground, the trading standards officers understand.
It is hard to believe that looking at whether people are using
nanomaterials is a particular priority at the moment given all
the things that trading standards or environment health officers
are looking at. We think the Novel Foods regulation needs to be
focused but it needs to be broad enough to take account of all
manufactured nanomaterials. But we also need to focus on the other
pieces of legislation that may be relevant to make sure that they
take account of the unique properties of nanomaterials. It is
no good just having it in the legislation; you need to make sure
that the people on the ground actually understand what the implications
are as well.
Professor Howard: I approach these problems
by saying that if we have been exposed to something throughout
our evolutionary history it is quite likely that we are going
to be adapted to it and be able to cope with it. When something
is brand new—you only have to look at some of the chemicals
that we have created that bio-accumulate and persist and have
hormone-disrupting capabilities—you have to take a precautionary
stance and then look at where it might have unforeseen effects
and do a proper risk assessment.
Lord Crickhowell: I have one question
which I think does arise from regulation and the re-examining
of regulation. I would be interested to hear Georgia's comments.
We have been talking entirely about food but she referred to agro-chemicals
and I do wonder whether included in her concerns are fertilizers
and agro-chemicals. I would like to know whether this is part
of the package or not.
Q292 Chairman:
Georgia, would you like to comment both on the European regulation
but also particularly whether you think we should be concerned
about the use of nanotechnologies in fertilizers and pesticides,
agro-chemicals?
Ms Miller: It was not my understanding that
the new European Parliament's suggested amendments were to encompass
naturally occurring nanoparticles so I do not want to comment
specifically on that because that was not my understanding. I
do agree with both Sue and Vyvyan that we need to focus our attention
on intentionally manufactured nanomaterials which are novel materials
to which we have no history of exposure. I do want to emphasise
though that where manufacturers are intentionally producing nano-scale
micelles or using nano delivery systems for active ingredients
this may introduce new issues and so we should consider those
as intentionally manufactured nanomaterials where there are intentionally
putting active ingredients, for example, into 30 nanometer micelles;
there may be a biological implication there. On the issue of whether
we should also be looking at nano formulated agricultural pesticides
and fertilizers, yes I believe we should. I think we need to engage
with some of the broader framing which is going on. When we read
some of the predicted uses to which nanotechnology will be put
in agriculture the vision is really quite broad and encompassing,
whether it is nano-automated farm systems or whether it is the
use of smart interactive nano-encapsulated pesticides and fertilizers,
or whether it is the use of nanoparticles to extend the reach
of genetic engineering in seed manipulation. There is a broad
range of proposed uses for nanotechnology in the agricultural
context and I think these are very relevant to a discussion of
nanotechnology in food.
Q293 Lord Haskel:
How practical is it to engage in this differentiation? For instance,
we modify existing natural products into nanoparticles; are those
manufactured and engineered or are those natural products? It
seems to me that we are approaching a regulatory minefield here.
Ms Miller: I think it is confusing so the approach
we have taken is to focus very squarely on intentionally manufactured
nano ingredients and additives, not so much to look at how nano
science is informing our historical use of emulsions and production
of emulsions but rather to look at things like nanoscale zinc
which is being intentionally put in as a food additive or nanoscale
silver which is being added to food packaging or whatever it is;
to look very clearly at those intentionally manufactured nanomaterials.
Having made that distinction and focusing very squarely on that
range, people are going to a lot of trouble and expense to actually
produce these things in nano form and then to put them into food
or food packaging. We then recognise that there is a need to actually
look at the things which are, for example, by-products of modern
food processing technologies. We are not including these in our
call for a moratorium and we are not suggesting even that they
be addressed by the regulatory system, but we are recognising
that contemporary food processing technologies do generate a lot
of foods which have nano fragments, nanoscale emulsions within
them. I think it behoves us to ask: is there any public health
implication there? I do think that if we all focus very clearly
on the intentionally manufactured nanomaterials both for regulatory
purposes and for the purposes of this inquiry I think we will
be better off.
Professor Howard: I think that if you take a
natural product and you treat it in some way by, say, encapsulating
it, and you change its dynamics from the way it normally behaves,
that is the time you have to look. Just harping back for a second
to pesticides, as I said before I have just finished six years
on the Advisory Committee for Pesticides which is where risk assessment
for pesticides is done, and they can see this nano revolution
coming. I did flag it up a couple of years ago and I think they
are considering maybe getting someone on that Committee who has
expertise in the field to maybe be able to put some input; they
are certainly going to need it.
Q294 Chairman:
Before moving on to ask Lord O'Neill to introduce the next question,
could I just try to nail this question of definition and what
your concern is. We have heard from the expert toxicologists in
previous sessions that their concern is particles that are persistent
or have particular functionality or reactivity in the body on
a nanoscale, not whether they are manufactured or natural. You
seem to be focusing on manufactured versus natural as opposed
to persistence and reactivity or functionality. Could I just be
absolutely clear where you think the critical issue lies?
Professor Howard: Persistence for how long is
a good question. Clearly if they are metal nanomaterials they
may persist for years but if you look at what the pharmaceutical
companies are doing they are using microsomes to encapsulate drugs
to increase penetration to the brain. There is a lot of research
going on; it is a difficult place to get drugs but they find that
if they use micro-encapsulation techniques they can increase penetration
of the blood-brain barrier. That has to tell us something about
what will happen in food products and if there are things that
do not normally go there they may only have a half life in the
body of somewhere around half an hour to an hour, but if you are
taking in a very large dose of those there may be significant
penetration. It really depends on what you mean by persistence
and what it means for that particular set of particles. I do agree
in general that long-lived metallic nanoparticles are things that
we have to be very careful about.
Q295 Chairman:
Georgia, did you want to add anything on that because you have
quite a broad ranging definition in your evidence?
Ms Miller: I did not actually see that distinction
in the evidence that the nanotoxicologists gave you; I did not
see them suggesting that we encompass naturally occurring nanomaterials
in the sort of dialogue that we are having right now. In fact
it seemed to me that they were talking about their concern about
nanomaterials to which we do not actually have a long history
of exposure. However, I do agree that persistence and functionality
are obviously going to have biological implications for the impacts
that nanomaterials may have when introduced to our bodies. The
thing that concerns me is that when we talk about persistence
that presupposes a level of knowledge about the biological behaviour
of nanomaterials that we just do not have. I think that is one
of the reasons that we have made this strong emphasis on focusing
on intentionally manufactured nanomaterials because these are
things which we are producing in this very tiny form and, as Vyvyan
says, sometimes in this very tiny form there are unique biological
availability and behavioural characteristics of these materials.
I do think it is useful to focus on manufactured nanomaterials
and I would include in manufactured nanomaterials things which
have been nano-encapsulated for the purposes of altering their
bioavailability or their behaviour in the body. I do think there
is a danger in defining nanomaterials by biopersistence when we
have so little understanding of their biological behaviours.
Q296 Lord O'Neill of Clackmannan:
Perhaps I could come back to Vyvyan Howard. We have been talking
about problems of definition and we have been saying that there
are categories in which there is a reasonable degree of consensus,
but then when it comes to issues of control you would apparently
favour, as it were, a one size catches all approach; you would
favour the generic approach rather than a case by case element
of control. Could you perhaps say how that sits alongside the
categorisations which you have been groping towards in the previous
questions?
Professor Howard: I feel there are many generic
aspects to this. Clearly size is something which is associated
with mobility, whatever the material. If you consider the amount
of money that is being pumped into grants for labs like Ken Donaldson's
(who was here) and my own to actually look into these generic
problems where we have vast areas of ignorance and are trying
to find out the way they perform and what the consequences are
likely to be, I think to ask individual manufacturers to go and
do that level of research is going to be impossible for them really,
it is much too expensive and they would not have the expertise.
My feeling is that we need to fill in some of these boxes in the
hazard assessment of these materials so that we can start to categorise
them and know that this size range looks as if it is relatively
safe or this size range is to be avoided because it gets to certain
places. I think there is a lot more spade work to be done before
we start to put the onus on manufacturers.
Q297 Lord O'Neill of Clackmannan:
Are there difficulties or dangers implied in a box ticking exercise
which does not get behind the questions in quite the way that
the safety considerations that we all have would seem to require
addressing?
Professor Howard: In 2004 I sat on a committee
which met in DG SANCO and as part of that exercise we tried to
construct a comparative hazard assessment with hazard triggers
(which can be done with pesticides where there is a lot of toxicological
information; you can actually make a sensible stab at it) and
all the boxes that we made for hazard triggers we realised very
rapidly were unknown; we did not know the answers. That is the
main thrust of the research that is going on now, to try to actually
get that knowledge so that we can attempt a meaningful risk assessment,
but we are not there at the minute. It is a very expensive avenue
of research; it requires extremely expensive instruments (electron
microscopes and things like that). My feeling is that we are at
the stage still where we want to learn more before we potentially
expose a population to high dose.
Q298 Lord Cunningham of Felling:
I address my question to all three witnesses, if I may. What would
be the merits of a register of nano-derived foods and food contact
materials as part of a comprehensive regulatory framework?
Ms Davies: We think it is something that is
essential because at the moment—I think for the last few
years—we seem to have been going around in circles where
it is very difficult to get a sense of exactly what is happening
in this area. A few years ago there was a lot of talk, as we put
in our written evidence, in some of the food technology press
about all the potential applications and research that was going
on, that leading food companies were conducting, but now the food
industry says that in general it is not using nanomaterials in
its products. If you look on the internet you will find various
products: you will find cooking oil, you will find food supplements
that are on sale coming from different countries claiming to be
using nanomaterials. It also seems that some of the kind of intermediaries
like the chemical manufacturers are also producing some food additives
that are produced in nano form. It is very difficult to get a
sense of exactly what is on the market. We think the regulators—mainly
the Food Standards Agency—need to be much more proactive
in actually going out and seeking the information and finding
out what is happening in this area, including talking to the chemical
companies who are producing food additives or food pesticides
and understanding exactly how much they are producing and who
they are supplying to. We also think there needs to be a requirement
that you should register if you are going to use manufactured
nanomaterials in your products and that should apply to food but
should also apply across the board in relation to nanotechnologies
and nanomaterials.
Q299 Lord Cunningham of Felling:
Do you think the FSA is the appropriate regulatory body?
Ms Davies: For food definitely and we think
it should be mandatory because, as I am sure you know, Defra has
had this voluntary reporting scheme that was launched over two
years ago and has only had 11 submissions on a voluntary basis.
I think it has to be mandatory but you also need to think carefully
about what the information requirements are so that companies
are not put off by something that is incredibly onerous and complicated
to fill in but gives the regulator the key information that they
can then follow up if they need to.
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