Examination of Witnesses (Questions 20
- 39)
TUESDAY 31 MARCH 2009
Dr Andrew Wadge, Dr Stephen Axford and Mr John Roberts
Q20 Lord Methuen:
The CST stated that the primary reason for this lack of research
was the Government's over-reliance on responsive funding to deliver
the necessary research. What has been done to overcome that problem
or would you not agree with that?
Mr Roberts: The question of funding is an important
one and the route we have chosen to go down is using the existing
mechanisms and existing programmes and seeking to coordinate them,
for example relying on the budgets of my department to look at
environmental issues, the Medical Research Council and the DoH
to look at toxicological issues, the Food Standards Agency to
look at food issues. This has the strength that the research is
embedded in those departments' programmes and those are the departments
who will need to use the research for their regulatory processes
but it does not mean that we have a single centrally directed
budget to drive forward the research.
Dr Axford: In terms of research councils, there
is a major cross-council programme on nanotechnology and even
within that, on the issues, for example, of toxicology, the Medical
Research Council has specifically had a call to look at that area,
to look at the implications of nanotechnology on health to the
tune of about £3 million.
Q21 Lord Methuen:
What is being done to look at the long-term effects of possible
toxicity due to nanomaterials?
Dr Axford: I would imagine that will be part
of the research undertaken.
Q22 Lord Methuen:
But you are not aware of what is going on at the moment.
Dr Axford: No, not the detail of what has actually
been funded under that programme.
Q23 Chairman:
What sort of response has there been to the MRC's call?
Dr Axford: It is fully taken up. It is a direct
programme but it is obviously there to be responded to.[26]
Q24Chairman: Mr Roberts,
in your helpful summary of the OECD assessment of risk associated
with 14 nanomaterials, as I understood it the 14 did not include
any potential food applications. Do you think it should?
Mr Roberts: I think it is right that it does
not contain many that are connected with food, although possibly
the nanoclays may be used in bottles and therefore may have some
link with food. They were chosen on the basis that they are ones
which are in production now and therefore where there is potentially
exposure to the environment or to human beings from those. It
is those where we have some evidence available in order to make
the assessments. It was a programme designed to capitalise on
what we already have and the challenges we face today rather than
a more prospective programme looking at potential applications
in future.
Q25 Chairman:
We have heard that, for example, the nanosilver particles are
used in food contact materials like chopping boards or refrigerators.
Is nanosilver included in the list of 14?
Mr Roberts: It is. Nanosilver was identified
by the Royal Commission as one that was potentially something
we should be concerned about. Defra has asked our Advisory Committee
on Hazardous Substances to have a look at the issues around nanosilver
and they are due to give us preliminary advice, although it will
require some further work.
Q26 Earl of Selborne:
On silver, when you mentioned earlier that there were two known
food products with nanoparticles, was silver one of them?
Dr Wadge: Yes, in relation to a supplement.
Q27 Earl of Selborne:
Yet the European Food Safety Authority has said that there is
not enough evidence to suggest that this is cumulatively safe.
How is it then that this has got through the system already?
Dr Wadge: Yes, that is one which will fall within
the system; at the moment it is outside the system, it is quite
a niche product and has been around for a long time. Under the
new controls on supplements, that will fall out of the permitted
list from January next year, 2010, because the safety data has
not been provided to support that.
Q28 Earl of Selborne:
That means that the material which is already available will be
withdrawn.
Dr Wadge: Yes.
Q29 Lord Crickhowell:
May I ask a general question and then follow up with a specific
one which has already been touched on? Mr Roberts, you have been
giving very helpful and impressive evidence, if I may say so.
We were a bit surprised that Defra's response to our enquiries
was a one-page note on pesticides. We wondered what Defra were
up to. Clearly Defra are more heavily involved than that indicated.
You have been doing your best to cover a lot of ground in response
to specific questions. Surely what we are going to need from you
is a pretty detailed report from Defra about all this work you
are clearly engaged in and about which we have not yet been informed
except by you this morning. May I ask that you follow up your
evidence—I hope the Chairman agrees to my request—with
a really detailed account from Defra of what you are doing, covering
all these points you have been talking about and adding any more
that you would like to include. May I then put my specific question
which follows two which have already been asked by Lord Methuen
and the Earl of Selborne in a way and that is on long-term toxicology?
Certainly the medical evidence that we received in an interesting
seminar we had indicated that we do not really know a great deal
yet about long-term effects. We know a good deal about the way
the gut absorbs and the effectiveness of the gut in dealing with
all the normal things, including some of the natural nanoparticles
which it has been dealing with for millennia, but we do not know
the long-term effects yet and we do not know therefore how these
nanoparticles move on into the other parts of the body, the brain
particularly and so on. Is one of these 19 research projects really
homing in on the need for this long-term assessment of nanoparticles
on the human body? If not, what is going to be done about it?
Dr Wadge: While John is looking through the
particular 19 projects, I should like to comment on that, if I
may? One of the real challenges for us is around the toxicological
assessment and the risk assessment. We have received advice from
our independent Committee on Toxicity and also the independent
panel which advises the European Food Safety Authority that whilst
the current risk assessment paradigm is appropriate there are
considerable gaps in our understanding along the way around exposure
and distribution and toxicity. I think that there will need to
be a considerable amount of research in this area and I know that
the MRC are picking up some of that. However, it raises bigger,
wider questions about whether we have the appropriate capacity
of toxicologists within the UK and that is something we need to
look at. I am sure that at an OECD level, consideration will be
given to develop harmonised risk assessment processes for nanomaterials.
OECD currently agree the toxicological assessments for long-term
effects of contaminants and other chemicals and it will be OECD
which agrees those risk assessment methods for the very specific
thing you mentioned around long-term toxicity. You are absolutely
right that this is an area which will need a lot more research.
Q30 Chairman:
Before we move on to the next question, perhaps we could home
in on the particular issue of toxicology in the gut which Lord
Crickhowell mentioned. We have gained the impression that, at
least in this country, there is rather limited expertise in that
area which is crucial of course to understanding potential risks
associated with food. I just wondered, either from the Food Standards
Agency or from DIUS, how many grants have been issued for research
in relation to toxicology of nanoparticles in the gut which would
be a central issue in understanding and filling the gaps.
Dr Wadge: We have just put a call out for our
first project on the toxicokinetics of nanoparticles and that
will be a collaborative project. We are very much at the early
stages here. The research we have commissioned so far has been
to carry out reviews: reviews of what products are available;
reviews of the regulatory framework; reviews of public engagement
and public attitudes to nanotechnology. We are very much at the
early stages and a lot more needs to be done. I am not familiar
with what MRC are doing.
Dr Axford: I am not familiar with the absolute
detail of what the specific projects are. We could come back to
you with information on that.
Chairman: Please do.
Q31 Lord O'Neill of Clackmannan:
Much play has been made of the OECD and EU. Where are our partners
in these organisations in relation to research and in relation
to the seemingly endless process of reviews that you have been
telling us about this morning? Are we missing out on other people's
research or are we further ahead? At the moment we do not really
know how we are comparing against, let us say, the French or the
Germans or the Italians or the Swiss. I am not asking for a league
table but we need to know how you are behaving or how you are
performing by comparison with people alongside whom you are supposed
to be working in these international organisations.
Mr Roberts: If I may say on nanotechnology generally
rather than on food, my impression is that the amount being spent
on EHS, environment, health and safety issues is broadly similar
in three markets, Japan, Europe and the US? They are broadly of
similar orders of magnitude both in terms of investment in innovation
and investment in health and safety research. We can see whether
there are more detailed figures and if the information I have
given is not absolutely right, I will try to provide something
in more detail.
Chairman: It would be helpful if we could
have some figures on that.
Q32 Lord Haskel:
Like other members of the Committee I am quite impressed with
all the work that you are doing on getting the science in place
and getting the research done. Meanwhile this industry has to
be regulated. It seems to me that the first thing you do when
you regulate is to define what it is that you are regulating.
I wonder whether you could tell us how you are going to define
nanotechnologies and nanomaterials in this context of regulation.
Dr Wadge: There are very many definitions out
there at the moment and we provide the BSI definition in our evidence
to you. I know that the European Commission is also looking at
definitions currently in relation to cosmetics but what they have
agreed there will also no doubt be broadened out at some point
in relation to food. From our perspective it is not so much the
exact precise cut-off point in terms of size, it is far more around
the properties which will have a bearing on the risk assessment;
whether it is biodegradable or not, whether it is persistent and
so forth, those are the key points. It is important that there
is some agreed definition and that is something which is being
worked up at a European level because that is where European food
law is agreed.
Q33 Lord Haskel:
Is this work on agreeing a definition within Europe proceeding
through the European Parliament Committee on the Environment?
Mr Roberts: May I make two observations? First
of all, I am not sure it is clear that we have to have a common
definition of nanotechnology across all regulatory regimes. Clearly
we need consistency; we also need to deal with the circumstances
of each regime. A lot of regimes will say that products have to
be safe and they have to be safe irrespective of whether they
contain nanotechnology or not. If they contain nanotechnology
then of course there has to be an assessment of the nanotechnology
component but you do not have to define nanotechnology in legislative
terms in order to achieve that. In terms of chemicals and nanotechnologies
generally, the EU Scientific Committee on Emerging and Newly Identified
Health Risks has proposed some definitions. I can provide a copy
of these but for nanomaterials it simply says any form of material
that is composed of discrete functional parts, many of which have
one or more dimensions of the order of 100 nanometres or less.
Q34 Lord Haskel:
So it is size.
Mr Roberts: It is size as the starting point
for consideration of risk.
Q35 Chairman:
Does that make sense toxicologically?
Dr Wadge: I think it does as a useful starting
point. If I may broaden out to the regulatory framework in relation
to food, we have looked at that and asked the very specific question
as to whether nanomaterials, nanotechnology, nanoparticles will
fall under the current regulation or could somehow squeeze through
the current regulatory framework. We received some reassurance
on that point from that review. Under general food law there is
a requirement on food businesses to make sure that any food which
is put on the market is not unsafe. That provides a general level
of safety. Then there are some specific pieces of legislation
relating to novel foods, food additives and food contact materials.
The food additives regulations have recently been amended so that
where an existing food additive is produced through nanotechnology
it would have to be assessed by EFSA for its safety, so it would
have to go through some independent assessment. Similar proposals
are currently underway and we are supporting those for the novel
foods and food ingredients regulations, also for food contact
materials. There is a sense that the existing regulation, once
it has been strengthened to capture the specific requirements
around altered particle sizes and changed composition and properties
of nanomaterials, that they would be captured under the regulations.
Q36 Lord Haskel:
What definitive view then are you giving to the food industry
if they come to ask you whether to label something as a nanomaterial
or not?
Dr Wadge: Labelling is a separate issue. The
first point is whether it would be permitted and we would provide
advice, as we do generally and we are in discussion regularly
with the food industry about products, about whether they fall
within certain requirements of novel food legislation and so forth.
If we felt that it was a novel property or a new size that was
being produced, then our advice would be that it would need to
be submitted for pre-market approval under the novel food regulations
or food additive regulations.
Q37 Lord Crickhowell:
What measures are currently in place to allow the Government to
monitor the use of nanotechnologies in the food sector?
Dr Wadge: That is something that is being considered
at the moment. Obviously if we are starting from a point where
there is not very much on the market in the UK we need to look
at what our role might and should be in relation to monitoring
the use of that technology. There are proposals for the European
Commission to produce a European register of nanotechnologies
in relation to food and we also have the option of producing something
within the UK. Our current thinking is that it would make sense
to work alongside the Commission to make sure we are familiar
with what they are doing and to see whether we then need to add
a further register within the UK. In terms of really understanding
what is happening in the market, a register clearly could be very
useful. However, our experience has been that as useful for us
certainly is the regular dialogue that we have with all parts
of the food industry about the technologies that they are developing,
the products they are developing and how they fit within the regulatory
framework. I have to say that a register might have some benefit
in terms of actually dispelling some of the myths which are currently
around that somehow nanotechnologies are being widely used in
food currently on the market in the UK because those are some
of the suggestions I have read in some articles. So a register
might be helpful in terms of dispelling myths in that way and
setting straight what products really are being used and not being
used.
Q38 Lord Crickhowell:
At one point in your answer I thought I was going to sum up as
"There are no measures currently proposed" but you actually
then said "We have our usual ongoing discussions with the
food industry and they are really the existing measures".
However, in your evidence you did say that you were seriously
considering a register. If you did have it, how do you think it
would work?
Dr Wadge: It is still very early stages and
we are still thinking that through and we want to see what the
proposals are from the Commission. I have to say that it is not
something we have done in any other field and we need to think
through the benefits of that. We do not, for example, have a register
of GM technologies that are used, a register of other different
types of technologies which are used in food. We would need to
think carefully about what the benefit of putting that effort
in to a specific area such as nanotechnology might be and that
is something we are considering.
Q39 Lord Crickhowell:
Defra has a voluntary reporting scheme. How successful do think
that has been?
Mr Roberts: It has not been terribly successful.
It has only generated a dozen or so responses in the first two
years. We are examining how we can make that more successful.
There is a challenge here between industry's desire for confidentiality
of new developments and our interest in knowing what they are
doing.
26 "To date the MRC has made five awards totalling
approximately £3 million from response (not directed) mode
funding. There is an open call and the submission of further proposals
is being encouraged. Details are included in the additional written
evidence provided by DIUS". Back
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