Examination of Witnesses (Questions 58
WEDNESDAY 3 JUNE 1998
J POOLE, DR
DAVID A EVANS
and DR SIMON
W J BRIGHT
58. Good morning. May I welcome you to the
Committee and thank you very much for coming to assist us with
our enquiry into genetic modification in agriculture. Could I
ask you first of all to introduce yourselves and say what your
different responsibilities are?
(Dr Evans) Good morning. My name is David Evans.
I am the Research and Development Director of Zeneca's agricultural
businesses. On my left here is Nigel Poole who is responsible
for regulatory affairs and public affairs for our biotechnology
business. On my right we have Simon Bright who has led much of
our biotechnology research in recent times and presently is responsible
for technology collaborations. Nigel and Simon have spent just
about all of their careers in biotechnology and have worldwide
reputations in this field. Indeed, both are honorary professors
at universities. In addition, Nigel is a member of the Advisory
Committee on Release into the Environment.
Chairman] Thank you
very much. We have your written evidence, for which the Committee
is grateful. Perhaps we can go straight into questions and ask
Lord Gallacher to start.
59. Dr Evans, what are the most important
implications of this technology for agriculture, consumers and
(Dr Evans) Essentially as an international company
Zeneca operates in over 146 countries. Indeed, 96 per cent of
our sales are generated outside the United Kingdom. We take a
worldwide perspective on this issue. Of course our headquarters
and our research are based in the United Kingdom. Biotechnology
is absolutely critical to our research programmes, in future product
offers and in the integration of crop management technologies.
We believe that biotechnology provides distinct consumer benefits
in three major areas: first, productivity, then quality, and then
variety. In terms of productivity, in my lifetime it has been
necessary for the world to increase its food production three-fold
and, given current population trends, that is bound to continue
and we shall need to optimise the inputs from technology to meet
those targets. In addition to population growth, food security
is also impacted by the requirement, the desire, for quality and
variety in food, particularly in developing countries, so we have
a major job to do and we require the technology there. Within
this biotechnology plays a vital role. Biotechnology regulation
is our contract with society to allow us to develop safe products
to present to this integration of crop management technologies.
From my viewpoint what is necessary for Zeneca is that my job
is about investing in research and development plans. We require
a framework of regulatory clarity to allow us to make optimal
choices in what and where and how we pursue our research and development
aimed at these ends.
60. What crops are being worked on at the
present time? Is the focus still on herbicide and pest resistance
or has it moved to developments of more direct benefit to the
(Dr Bright) Biotechnology techniques are being
applied essentially to the full range of crops which are being
improved through breeding and selection means, so this is another
tool to the armoury for crop improvement. The initial focus is
on single gene traits such as modification for herbicide selectivity
or insect resistance. The new crop protection genes and technologies
which are going to come will do things which are more difficult
than the first generation products, such as controlling fungal
diseases and controlling difficult-to-get-at beasts such as things
which attack roots. As well as improving crop protection and crop
productivity, there is an increasing amount of research going
on around the world and in our company on things to do with understanding
what is the genetic basis of quality and then doing something
about it. If I could give a couple of examples, we are interested
in how the genetic basis of flavour works and how that can be
improved. We all know in principle that eating vegetables is good
for you. We can now begin to get at the underlying science, the
genes that control the production of nutrients so that you can
then have programmes to improve the nutritional qualities of fruit
and vegetables. That is an example of a direct quality attribute.
We also have work going on which has its primary benefit in environmental
improvement. For instance, we have got a research programme where,
by expressing a particular enzyme in a plant that goes into chicken
food, you can then reduce the amount of phosphate pollution that
comes out of intensive chicken farming practices. There is a whole
range of activities both within our company and in other companies
and to my mind this is something that is going to be very pervasive
technology which will provide extra choices on how you do things
in agriculture, both for productivity and for quality improvements.
61. You mentioned, Dr Evans, that you operate
in 146 countries, I think, and you said that your developments
were of particular relevance in developing countries. Perhaps
you could enlarge on that and tell us something about what crops
you are working on in less developed countries' agriculture.
(Dr Evans) The first point to make is that by
means of enhanced crop protection technology does allow countries
to grow crops which hitherto were not possible. One good example
would be bananas which suffer from a very debilitating disease
which is presently not well controlled by current technology.
Providing solutions to this problem (it is a disease called black
sigatoka) is one of our research objectives. In addition to crop
productivity it is clear that our technology worldwide provides
benefits to the productivity of food, in other words the yield
enhancement of food, in many countries. The technology is applicable
to crops in general.
62. What percentage of your research or
expenditure is going in less developed countries' agriculture
as opposed to that of developed countries?
(Dr Evans) We have a crop list which is relevant
worldwide. Essentially we operate worldwide so I find it difficult
to give an exact answer to that. Our perspective is entirely global.
The United Kingdom is actually a rather small percentage of our
market and we have to operate globally. For example, in crop protection
we are certainly number one or number two in Asia. In the world
we would be number three, so our perspective is entirely international.
63. I can remember being told 10 years or
so ago by Lord Rothschild that one of the things that would have
the biggest effect on the agriculture of less developed countries
would be if you could create a wheat which had a capacity for
fixing nitrogen from the atmosphere. Could you tell us what you
are doing about that and what prospects you see for that sort
of wheat being produced?
(Dr Bright) Ten years ago I had that on my list
of things which were impossible and I have now moved it on to
my list of things which are just very difficult. The underlying
science about what is required to make that productive symbiosis
is coming along. It is quite clear that this could have a benefit.
As a research manager I am still dubious about advertising when
we can crack that problem. It is certainly very difficult, but
I think it is one of the things if you like that you can put out
there as an aspirational target to say, "I would like to
understand how that works", and by doing that you can either
replace or supplement fertiliser application. I would not hold
my breath and say that within the next 10 years there will be
a product like that. I think it is very difficult.
64. Can I move on from the speculation area
into an area where you have achieved a product in the market and
ask you at what stage is your application for growing GM tomatoes
in the European Community?
(Dr Poole) I think a bit of history might help
first of all. This was an invention in Europe but we did most
of the development in the States. We then wanted to try and bring
it into Europe because the process in this kind of technology
suits our invention much better in Europe. We decided to bring
it to the United Kingdom first of all and there were several reasons
for that. One of the most important reasons was that at that time
the United Kingdom already had some very well respected regulations
and, apart from the Netherlands, no other European country had
those regulations, so we were able to get that comfort. We have
to have a regulatory framework before we can bring a product on
to the market and that was in place. It was a United Kingdom invention,
the United Kingdom is our base, and I suppose we were also getting
rather fed up with being told that Europeans are Luddites and
would not dream of eating modified food. We wanted to test that
and we also wanted to test whether our approach to the market
and working partnerships would actually work. As you know, we
brought it in in 1996. To date we have sold well in excess of
1.6 million cans in Safeway and Sainsbury. All that is sourced
from California, it is processed in California and it is shipped
over here. It is sold side by side with tomato puree produced
in Italy. I suppose if you like we are putting Italian farmers
out of jobs. We have now asked the European Union if we can grow
and process this in Europeit will grow in the southern
states. That application we deliberately held back for 17 months
in the hope that there would be some clarity in the European regulatory
system. We submitted it via Spain and it is now 17 or 19 months
since we had it submitted. Spain approved it, it has gone to Brussels,
it has gone out to the Member States. It was considered by the
Scientific Committee of Plants a month ago, which we believe is
a favourable report. We are now waiting to go through the next
steps. In our written evidence we have given the timescale of
going through US, Canada, Mexico as well, so you can judge the
65. So it will not be until 1999 at the
(Dr Poole) We will not be planting and growing
commercially until 1999. This is the growing season. The tomatoes
are in the ground already. It is too late this year.
66. Is there any particular reason why it
is being held up as far as you know?
(Dr Poole) No; I think it is going quite fast
through the European system compared with other products. There
were two objections. One was from Austria on the presence of kanomycin,
and one was from France on a general issue about genetic modification,
but both those were considered by the Scientific Committee and
we are waiting for their official report now.
67. As far as animals and fish are concerned
are you doing any work in the genetic modification of either?
(Dr Evans) No, we are not.
Lord Wade of Chorlton
68. First I ought to declare an interest
as a farmer and as a non-executive director of a company which
deals in international trade on meat products, fish and milk products.
I would like to ask you about the difference between the EC and
the US. Would you comment first on the differences between the
EC and the US approval processes from the point of view of the
applicant, both in theory and in practice? Then I would like you
to comment on your experience of bringing GM food crops from the
US to the EC.
(Dr Poole) We have worked in many countries. If
you look not just at the US but Canada, Mexico, Australia, you
actually find the questions you are asked are very similar to
the ones you are asked in Europe and that is not surprising because
all those countries are using a risk assessment system to evaluate
the risk and make a decision. That is a scientifically based system
and is a worldwide approach. The questions are the same. The amount
of detail in Europe is slightly more but the difference we find
comes in the next phase. It is actually deciding on those answers
we have offered. That is where we seem to be hitting problems.
This lack of transparency about the whole process and who makes
the decisions is a real problem to industry at the moment. We
need a route map, as Dr Evans said. Our most important criterion
for a decision to develop a product is a clear regulatory route
map and at the moment it is very difficult to get that in Europe.
69. Could you tell us about your experience
of moving GM crops from the US into the EC?
(Dr Poole) As a company we were the first to bring
into Europe a product which was approved in the States and sold
in the States. Frankly we had no problems with those tomatoes.
70. Lord Chairman, I am afraid I neglected
to declare an interest in the last question I put. I am a farmer.
I also have some shares in your company. We have had a document
from our specialist adviser on "The Gaps in the Regulatory
Oversight of Biotechnology in the United States". You have
not seen this. There was a briefing for the Committee. I will
read to you two sentences at the beginning. It was a briefing
for this Committee. He says: "There is no regulatory system
for ensuring the safe use of biotechnology in laboratory or factory
use where the organism is not to be released into the environment."
He goes on to say a little later: "The United States Government
decided there should not be special legislation to assess the
safety of the products of biotechnology." I find that in
rather startling contrast to the comment in your paper, paragraph
11, at the end, and again I quote: "Meanwhile, the USA has
in place a regulatory process which is widely respected by both
industry and consumer." I do not know if you would like to
make a brief comment but what I think would be helpful is if you
could take Dr Kinderlerer's paper away with you and let this Committee
have your comments on it because there seems a very clear contradiction
between what you are saying and what he is saying.
(Dr Poole) There is actually not a contradiction.
May I develop it? First of all, in our presentation we are talking
about a deliberate release into the environment and not laboratory
work. Way back at the end of the eighties both the United States
and Europe were considering how to frame their regulations, and
we have to go back right into history. The Americans said they
could actually, under their law (which is a different legal system
from ours in Europe) fit in the biotechnology regulations under
products' legislation. To get approval for example for the tomatoes
we had to get approval from the United States Department of Agriculture
to grow them, to transport them and to process them at the federal
level. We also had to get state level approval if we crossed state
lines. The US GM law is under plant protection legislation they
have already got in place, and to consume it you have to ask the
FDA if they can see any reason why this product should not go
on the market, which is again a catch-all phrase they use in their
legislation. That regulatory legislation did not exist in Europe.
At that time, remember, we were still individual European States.
We were moving towards a European environmental process in 1992,
and therefore Europe decided to set up its own legislation. I
come back to my original comment that when you get down to it
the scientific questions we have to answer in both lots are virtually
71. Could I ask you whether you would send
us a report on this?
(Dr Poole) Yes, of course.
Baroness Young of Old Scone
72. You have already told us quite a lot
about your experience of the EEC regulatory system on the tomato
issue. On other issues, or indeed on the tomato issue, have you
had a different sort of experience depending on the EEC country
you have applied to for approval?
(Dr Poole) We have worked in the Netherlands,
France, Spain, Greece and Portugal. I think as a general statement
we are extremely impressed with the regulators, the people who
have to carry out the regulations, in all those countries. We
find them very professional. I suppose you would expect us to
say it, but we are very impressed with the United Kingdom regulatory
system in place. We think it works very well for the United Kingdom.
The problem in the other countries is that you get buffeted by
political issues which can cause confusion and that is where the
delay comes in. The track is actually better in the United Kingdom
than in most other countries. It is pretty good in the Netherlands
as well. Once you go into countries with less experience, naturally
they are trying to build their experience and you start being
asked about issues which are not part of the risk assessment.
73. And these are being asked by the regulators?
(Dr Poole) They come through the regulators because
that is who we are communicating with. I am not au fait enough
with the political system in those countries to say who is actually
originating it. You are asked questions about public acceptance,
or "Will our farmers accept it?", which are not part
of risk assessment. You are asked, "Is there a need for it?",
which is not part of the risk assessment process which is concerned
74. If I could apologise, I should have
declared an interest before I began my questioning. Perhaps I
may do that now. As Chairman of English Nature, the Government's
statutory adviser on biodiversity, I have an interest in biodiversity,
and I am also a member of the Minister of Agriculture's advisory
group. Can we move on to the issue of company responsibility,
or indeed anybody's responsibility, in this field. Do you think
the company should have a responsibility, for example for consulting
(Dr Poole) I would like to take that back again
to the tomatoes because it does show the way we like to work.
You need many other things to come together, not just to bring
the product out but to make a commercial success. The stakeholders
are an essential part of that. When we started the launch of the
tomatoes we communicatedand, I want to emphasise, we listened
tomany different parts of society from the media to civil
servants, to Members of Parliament, Lords, members of the European
Parliament, local people and consumers. We tried our best to build
their thinking and their thoughts into the way we behaved. When
we came forward we thought this would be the first such product
in Europe. It is easy for us: it is our culture, but we wanted
to make sure that there was choice. That was never a question.
The reason we labelled our tomato puree was not for safety reasons
at all. It was simply because we wanted to give information to
the consumer. If you went round the stores you would find leaflets,
and very well written leaflets, if I may say so, by Sainsbury
and Safeway, actually explaining what biotechnology was and how
it was done. That is how we approached our case. The answer is
yes, our stakeholders must be involved.
75. What you have described sounds like
a communication process. Do you think that consultation with stakeholders
should be part of the regulatory regime?
(Dr Poole) One of the problems we have in Europe
is actually working out which box you belong in. They are all
equally important. Our concern at the moment is that the risk
assessment system is based on very well tried, very well respected
scientific principles and that is the basis of our risk assessment
process. That is determining safety. Issues such as, for example,
is it needed or does society want it, belong in this building
at the end of the day. There are other issues which are equally
important. I think biotechnology in Europe has become a lightning
rod for all these other debates which are going on and I think
we will need to separate risk assessment. The rule on that is
to determine safety. That is advice given to a minister who then
decides. Other issues are just as important and we do not decry
them. They do not belong in the risk assessment process.
76. But would you see them as part of the
overall regulatory process?
(Dr Poole) I believe in a democracy, yes.
77. In the event of something going wrong
with a GM crop, who would be liable?
(Dr Evans) GM crops are no different from other
crops or indeed other products. The producer would be liable.
78. The grower?
(Dr Evans) The producer can be defined as anything
from the grower right through to the importer.
79. In your opinion do consumers accept
a share of the risk and the liability if, when they purchase food,
it has been labelled as containing GM material?
(Dr Evans) Our policy of course is to market products
that are safe so in reality we do not believe that consumers think
in that way and I certainly do not. Our policy is to make safe
products and to ensure the excellent testing of those products.
I can tell you, and I think it will not be disputed by many, that
we have one of the world's best industrial toxicology laboratories
based on decades of experience of course with agri-chemicals,
and we also have one of the largest environmental laboratories
in the United Kingdom. Our policy is to produce safe products
which have passed all the regulatory hurdles, and that is our
stance on this.