Examination of witnesses (Questions 660
WEDNESDAY 28 OCTOBER 1998
JAMES and DR
660. Is it more important to improve the
quality of the committees' advice or the method of their operation?
(Professor James) I think it is more important
to improve the method of their operation by having much more effective
support and by having much clearer specification of what the processes
are within the Commission. Then we just do not come into a problem
blind but know that a particular DG has had a meeting with a Standing
Committee, that this issue arose because there was a dispute between
x and y on such and such and that is why the question has been
put to us. Then we could begin to understand how to address that
issue instead of just having "what do you think about this"
and a very preliminary limited explanation. I think there is a
lot that the Commission can do and I think it is in the process
of recognising that. I am not in the business of attacking the
Commission today, they are desperately struggling to cope in my
661. Professor James, we turn to the question
of stopping the clock. Under the proposed revision of Directive
90/220 it is proposed to stop the clock while the scientific committees
are consulted to resolve inter-Member State disputes, even though
if the clock was not stopped the committees would still have three
months in which to formulate and deliver their advice. In that
context are you in favour of stopping the clock?
(Professor James) I am in favour of stopping the
clock but Dr Chesson is under the gun on GMOs. Perhaps Dr Chesson
will respond and disagree if he wishes.
(Dr Chesson) I think in practice the clock is
automatically stopped. You are quite right that often there is
a three month period but you have to remember that most of this
is being done on a voluntary basis. If this was a full-time committee
or if you had experts who were seconded permanently to these committees
then I think the three month period might be a reasonable time
span, particularly given the time available to people who actually
have to evaluate very complex dossiers. Sometimes people do not
understand quite how large they are. I once had delivered 84 volumes
of a dossier on virginiamycin resistance. This is not something
you would take home and read overnight. The expectations and the
amount of information you have actually to consider requires time.
If the evaluation is going to be sound and thorough then it seems
to me that one should not force a time period for a reply.
662. Can I ask just as a matter of information,
is all this having to be done in all of the languages of the Community?
(Dr Chesson) The tendency is for the working language
to be English, as you might expect, certainly in the working groups.
In the plenary sessions there is simultaneous translation. The
dossiers are provided usually only in one language and that is
not necessarily English.
(Professor James) Could I add that stopping the
clock is a very sensitive issue. It is exasperating for some groups
and industry, for example, to put forward a proposal and find
that wherever they go at each step the clock has been stopped.
I think we need to look at that in terms of the mechanism by which
the approval process is gone through. If Andy Chesson has 84 volumes
to consider on one particular topic then you can hardly expect
an international group to come to a conclusion on that within
three months. However, the issue is how many steps has it gone
through before this key set of decisions is taken. I think that
is where the improvement should be rather than in specifying that
he not only has to give up his Sundays, he has to give up his
days at the institute routinely as soon as somebody somewhere
demands that he reads another 84 volumes.
663. So you are in favour of stopping the
(Professor James) Yes, I am in favour of it but
I think we could get a more efficient method of analysis which
in effect speeds the general process up but does it properly.
I think we need both and that is the challenge.
(Dr Chesson) If I could just make one comment.
I think in relation to genetically modified crops we are going
to run into a problem where the time spent on evaluating these
materials is actually going to increase and not decrease. That
relates to the way in which the legislation is going to be handled.
At present scientific committees are asked to consider the crops
under 90/220 primarily for release. If the material has a food
application then it will also be considered by the Scientific
Committee for Food, under EC No. 258/97, and we are about to have
introduced a novel feeds regulation to match the novel foods regulations,
so if it has a feed implication it is liable to be examined under
the novel feeds legislation. So it is going to be very crucial
as to how those various pieces of legislation are organised and
how the scientific committees are organised to deal with them.
My personal view is that it ought to be a one-stop process, that
a composite committee ought to be able to respond under all three
pieces of legislation. What concerns me is information passing
from one group to another group asking almost exactly the same
questions and requiring almost the same evaluation in each case.
I think that is a foolish waste of time. The other thing that
concerns me about that process is that there is a tendency for
things to slip between the cracks between the various evaluations.
You may have a case where you have a genetically modified plant
which one committee has a slight concern about but not necessarily
enough to suggest that it should not be released for growth in
Europe and a second committee may have a slightly different qualm
about the same material but the two never get together and therefore
there is never any overall weight of evidence which would mitigate
or question the safety of this material. There is a great deal
of danger in splitting up what is essentially a single problem,
a single evaluation, and being seen to be handled by a number
of different committees and processes.
(Professor James) That is exactly what we are
going to consider. Having realised this in talking with Andy Chesson
I wrote to the chairman of the Scientific Steering Committee and
he circulated my letter dealing particularly on GMOs. It is these
sorts of issues that we think we should be tackling as a coherent
whole. We are proposing that we need to rethink this in terms
of the way the Community handles the problem.
664. There are obvious implications for
the developing world through the use of GMOs but could you say
what the implications are for developing countries considering
international property rights and also the use of patents which
might actually affect them adversely?
(Professor James) As some of you know I am Chairman
of a United Nations' Commission at present looking at future food
needs on a world basis. I was privileged to be asked to do this
by Richard Jolly who is the leader of the UN Development Report.
Dr Gro Brundtland and Mabul ul Haq and I were appointed as the
three commissioners. Dr Gro Brundtland now is in charge of the
World Health Organisation and had to decline and Mabul ul Haq,
former Treasurer of Pakistan and founder of the UN Development
Reports, unfortunately passed away suddenly earlier this year
as you will know. We have been looking at your problem and we
meet again in Madras in three weeks' time to look at these very
issues. There have been two recent major meetings in Britain.
You may be familiar with the Royal Society meeting on this issue
and the Rank Prize Fund meeting which has just been published
in New York on feeding a world population of more than eight billion
people. If you also look at the work of the new director of the
Rockefeller and the way in which the Rockefeller Foundation is
going about tackling this problem then it is clear that they are
very conscious that there is a huge issue of the Third World.
If you look at global food needs we have a problem of whether
we can keep putting up the plant yields, because that is fundamental
to being able to feed the world. The way in which one puts up
the yield is by manoeuvring, choosing, selecting crops that can
handle a limited water supply, salinity, and so on and so forth
far more effectively. The amount of land that is going out of
production is at the moment worrying because of the huge growth
of the mega-cities. The Third World has an enormous need for help.
What you are pointing out is exceptionally important and was highlighted
by UNESCO two or three weeks ago: there is a huge intellectual
or, if you like, capital asset gap between the First World and
the Third World. If you look at the new analyses, and I have recently
been to Washington to the International Food Policy Research Institute,
they have come to the conclusion that the Third World has a desperate
need for enhanced agricultural research. In Europe we have tended
to conclude that agricultural research post-war now needs to stop
or be reduced substantially because we have got too much food
being produced. On a Third World basis, however, agricultural
research is desperately needed because to get the increased crop
yield you need the best new developmentsof selection with
this selection to include GMOs. The question is how are you going
to get that through on a practical basis. I think that we tend
to go for magic bullets too often when we look at Third World
issues. New analyses suggest that if we are going to make progress
we have got to have the same major community involvement that
has been shown, for example, in Tanzania, in Thailand, in parts
of India, the Tamil Nada project and so on. I think that M S Swaminathan,
the ex-director of the Rice Research Institute, is convinced that
we have to have a panoply of different crops, not just a few GMO
crops. I think that if Britain is interested in helping the Commonwealth
and the Third World it should be seriously thinking about how
best to develop schemes with Third World countries so the marvellous
capital assets in intellectual terms of British science and of
British companies can be linked in a way where the Third World
does not believe that they are being rapedI choose the
word advisedlyby companies and other Governments who make
use of precious assets from, for example, the Amazon Jungle in
terms of crop varieties. How are we going to cope with that? I
think it is a huge challenge that has not been addressed properly
665. Going on looking at patent law over
these issues there are countries which in the present system in
reality on the ground will not be able to afford certain crops.
Peasant farmers will not be able to afford these enhanced crops.
How is that gap going to be bridged?
(Professor James) I think it is a major issue
and I do not have an instant answer. The research community, particularly
in the United States, for example in the Rockefeller Foundation
and elsewhere, are very much involved in charitable funded work
for the Third World where they are trying to protect patents.
I think there is a potential for a new dimension of private-public
partnership where in fact national governments with World Bank/IMF
support became involved. The IMF and the World Bank, I am sorry
to say, in the current crisis have shown a complete failure to
look at the social, economic, agriculture and human dimensions
of structural adjustment. They are not recognising that actually
a much more sophisticated response is needed. I would be in support
of the World Bank and the IMF being much more locked in with the
major companies in trying to develop new ways by which the Third
World can profit where the industrial countries know that they
are not going to get the same return but they have not put in
all that money themselves either. So it is a joint venture for
Third World benefit.
666. Can I just ask one more question. There
was some talk that the Australian Seed Bank were thinking of actually
patenting seeds within what is seen as almost a global resource,
they are actually patenting seed stock. Do you think that is tenable?
(Dr Chesson) Personally, no. I am very concerned
about the whole restrictive process of patenting of genetic information,
cotton being a classic example. I think there are a number of
issues that come out of this technology. There are serious dangers
for the Third World. One I can see is actually the increasing
emphasis on cash crops for Third World countries. This has already
proved to be a major problem for many African countries where
you get international companies producing cash crops of little
value to the actual country itself but pushing the food production
for that country out into the marginal lands. As we see more and
more GM crops with higher value products it is going to be increasingly
attractive to grow crops like this where there are low labour
costs. I think that is going to put even more pressure on the
existing lands within the Third World. There are dangers concerned
with the introduction of GM crops in the Third World. There are
clearly very good potential benefits but I am not sure that these
are always given the highest priority by breeding companies which
are based essentially in the US, in Europe, in Canada and in the
developed world. For instance, you would probably have more impact
on nutrition in the Indian Sub-Continent by increasing the degradability
of the rice straw fed to buffalo and other animals than actually
increasing the seed content of that rice because this would have
a major impact. I think you would be hard put to suggest to breeding
companies that they could get an economic return on doing that
sort of research. I echo very much what Professor James was saying.
I think the only way forward is for Government to encourage a
partnership in which scientists from the Third World are not actually
brought over to countries and put to work in research institutions
for the benefit of the research institutes, but are possibly organised
such that they can do research within multinational companies
on projects which those multinational companies might not have
given a high priority. I am sure there is a mechanism under those
circumstances for working out IPR to the benefit of both. There
are ways forward if one is reasonably imaginative.
667. It is unclear from the Directive whether
the scientific advisory committees, when called in to resolve
inter-Member State disputes, will comment solely on the dispute
or whether it will re-examine the entire dossier. Bearing in mind
what you said earlier would the latter concern you and is that
the more likely outcome at the moment?
(Professor James) I think that in coping with
a particular question quite often there seems to be a very narrow
area of dispute. In practice when you look at it some of the issues
are really quite broad. It seems to me that most of the scientific
disputes in Europe will already have gone through a scientific
committee which will have looked at the entire dossier of data.
I do not think it is as bad as you may think. If some quirk comes
up and you think a terrible committee is going to take another
three years before it comes up with a view on it, then I do not
think that is going to happen. I think that we can get into trouble,
as we discovered on Friday on bones and BSE, if we take a very
narrow perception of what is being disputed within the standing
committees. I think one has to take a breadth of perspective without
necessarily going back and re-examining the whole dossier. I am
sorry, that is not a straight answer.
668. So you do not think that the scientific
advisory committees are being abused? You do not think they are
being asked to put aside the wrong questions? They are overloaded
but they are not being misused.
(Professor James) On the whole I do not think
they are being misused because I think DG XXIV is really very
intent on developing a new culture which is very different from
the old culture. They are, in a sense, protecting us from the
old schools. How that is going to work through I do not know.
I do not think that they are abusing us. Certainly in my experience
we get quirky questions from other Directors General which have
very complex political reasoning behind them and usually we discover
what that is and then we come back and give the general picture
without regard to the political machinations.
669. Can I ask you a question about the
precautionary principle. Do you agree that the step by step approach
of the precautionary principle is the way to proceed with genetic
modification? Is it being implemented in the United Kingdom in
the right way in handling GMO release applications?
(Professor James) I think Dr Chesson is better
answering that but I would make a general point about the precautionary
principle. This has come to me powerfully in the last 12 months
in terms of BSE. If you take the precautionary principle to its
extreme you will say "I think there is a theory that there
is a problem in this particular area, therefore if there could
be a problem we will not actually allow anything to proceed until
in fact we have got a beautiful scientific analysis of whether
that theory might be operating or not". In practice I think
that if one takes that to the extremes that I have seen some scientists
taking with BSE, one would get to the point at which you would
shut down the whole of the agricultural food supply in Europe,
and I mean that literally. In terms of GMOs I do not have enough
practical experience of that step by step approach to know whether
that is a big problem in Dr Chesson's committee.
(Dr Chesson) I have a horrible feeling that it
is actually an excuse for inaction. Bear in mind what has happened
with antibiotic resistance markers that are used in the selection
process with GM plants. There has been an enormous debate over
the last few years about the use of such markers. The interesting
thing is that the companies have responded to this debate because
they still have a market to sell their crops, they are still very
anxious to get these crops into Europe and growing in the US.
They have responded by actually improving their technology to
the point where the products that are coming on line now simply
do not have antibiotic resistance markers. I am not convinced
that if there had been a precautionary principle in action there
would have been the same incentive, if you like, for the companies
to make those changes. I suspect that it can work in both directions.
If you have the precautionary principle it also seems you know
precisely the question that will need answering before you allow
the next stage to proceed. Again, I am not sure how you actually
arrive at that question.
(Professor James) I was involved in the novel
foods where we were pretty angry there were antibiotic resistance
markers coming through into the food chain. We explicitly stated
so in our public releases and so on. I think that the precautionary
principle is, if you like, a very good way of starting because
you are thinking about all sorts of issues. The question is do
you stop everything on the basis of theory. I think that is back
to the discussion about trust. You have to get to the point where
you have people with genuine concerns so involved in the process
that they realise that it is reasonable to go forward not knowing
everything at this stage. If there is real concern you put in
mechanisms whereby you can survey the potential impact of the
changes so you can have an early warning should there be a problem.
If you do not believe that balancing the judgment is really the
issue, then you need to give me examples of how there might be
some obscure problem which emerges when a balanced judgment is
made. We are always going to have that problem when we are trying
to make judgments. I think to balance the argument we need a lot
of different groups involved in the committees, so you can build
reassurance. For examplepeople who are very much involved
in Friends of the Earth ought to be brought into this discussion
and not rubbished; neither should the industrial companies be
rubbished. We have got to build a new mechanism for getting a
proper interchange so we understand the dimensions of these issues.
670. You expressed your concern about the
use of antibiotic resistance marker genes, and we have had many
discussions about that in this Committee, should they be banned
and are there other genes to use? Would you have the same concerns
about the use of fish genes in plants? We have heard about a gene
from the arctic chard being used in some plants as a sort of anti-freeze.
(Dr Chesson) As I said, you have to look at everything
on a case by case basis. You have quoted two examples which are
quite radically different. Yes, I would have questions to ask
in both cases. Those questions would be specific to the genes
that are being introduced. If one can answer satisfactorily those
questions then my concerns would be allayed. If one could not
answer satisfactorily then of course one would not be able to
clear something as safe for release.
(Professor James) If I may come in, let us take
the fish gene, which I am afraid I did not know of but Andy Chesson
would doubtless. If that introduces an anti-freeze component I
think that it is proper that in a committee one should look at
the dimensions of what that might signify and one should think
of all sorts of different areas of concern that might arise. You
need to sit in on some of our British committees, where we run
around with all sorts of crazy ideas before saying "okay,
that does not seem to be an issue". I think we need more
of that but done in a reassuring and involved stakeholder context.
Then we will begin to make better progress.
671. We have been talking this morning about
the situation that meets us at the moment. Would you not agree
that we are going to see a torrent of new developments in the
years ahead? We are only scratching the surface of this. How are
we going to cope?
(Professor James) I am not sure that I know the
answer. I think that one has to look at it piece by piece but,
in addition, one needs to have the ability to pull back and say,
for example, on this issue about herbicides whether in fact there
are going to be major impacts on the environment and so on. That
is a very proper concern. There is a quantitative issue there
as well as the specifics relating to each gene. I think it is
very important that we have expert committees that are not just
relating to the minutiae of a genetic modification but are dealing
with the broader issue. If a torrent of genetic manipulations
is on the way are there special questions that we need to think
of now by virtue of having a multiplicity of changes in that particular
sector of plants, or indeed animals? I think the GMO changes in
terms of animals are likely to be much slower because of the huge
antagonism to major changes in animals as distinct from plants.
That is the view that we had in the Novel Foods Committee. We
took on the public dimension of concern and therefore did not
allow, for example, various gene manipulations to enter the food
chain even though it had been shown that the genetic construct
had not gone into the animal. We were so concerned that people
would feel outraged by the idea of eating an animal which had
been subjected to genetic manipulation. Although the ethics expert
on our committee said that putting a human gene into an animal
is ethically entirely appropriate, I and many other members of
the committee thought that might be correct in strict almost legalistic
ethical terms but one had to deal in a societal context with people's
understanding. I think that we need this interactive debate. It
is not a question of persuading people that everything is all
right. It is a question of moving forward, if possible on a consensual
basis. We cannot do that unless we do take the broader view as
well as dealing with the specifics of each singular gene.
Baroness Young of Old Scone
672. I wonder if I can just take you back
briefly to the precautionary principle and the concerns that it
should not be interpreted as not being able to make any movement
forward unless everything is known, because I would accept that
not everything can always be known. I wonder if you could just
describe whether you think it is possible to combine the precautionary
principle with an adequate assessment of the scale of risks so
that you get a feel for occasions when the scale of risk is sufficient
that you do want to take a more precautionary approach and occasions
when the scale of risk is less.
(Professor James) Thank you for a very penetrating
question. One of the groups that I am involved with in Brussels
is dealing with exactly that and that is the discussion that I
had with the former CMO, Ken Calman: how do you begin to put a
new dimension on risk analysis? There was a Treasury report on
this last year as to how you look at the risk in environmental
risk, human health risk and so on. I think that what has come
through to me in the last year's struggle on the BSE risk is that
we really have to move into a new dimension of understanding and
start to express risk in a more meaningful way, not simply for
the purpose of communication but for understanding. For example,
the Health and Safety Executive perceives that if you are in the
oil, mining or nuclear industry crudely speaking one in a million
risk is the threshold for acceptable risk. People employed in
that industry know that they benefit from that industry and the
trade unions and everybody involved thinks that one in a million
is reasonable. As I said to the Scientific Steering Committee
in Brussels last week, that means that in Britain we should "allow"
50 cases of new variant CJD to be running as a routine per year
in Britain. That is of course unacceptable. It is unacceptable
because we are in a different dimension, because the whole society
is exposed and they did not make the choices and see any selective
benefits and so on. I think we are actually going to have to think
through in a new way an integrated view of risk and set it out
in a more explicit way and involving stakeholders. Then we can
come to a judgment, and an explicit judgment, about the risk.
Traditionally in Britain we have taken a completely different
view from the United States on risk. In the United States they
have gone down the quantitative analytical approach whereas in
Britain a group of experts have decided that, on balance, something
is acceptable. I think by virtue of all the anxieties about food
in Europe we are going to have to go much more down the American
route of being more explicit, more analytical, more effective
at communicating relative risks and better at demonstrating why
we are making judgments in these different dimensions. Until then
we are going to be challenged to use the precautionary principle
on the basis that we are making all sorts of judgments with so
little evidence at hand. I am not giving you a straight answer
but I do believe that in trying to cope with risk we ourselves
as scientists are going to have to go into a new dimension of
thinking and analysis which some of us have not coped with terribly
Chairman: I think
that brings us to the end of the questions that we wanted to ask
you. Professor James, Dr Chesson, thank you both very much indeed,
on behalf of the Committee, for having come and given us extremely
interesting and helpful evidence. Thank you.