Memorandum by Zeneca Agrochemicals and
Zeneca Plant Science
Zeneca welcomes the opportunity to provide evidence
to the committee.
1. Zeneca is a world leader in bioscience with
its business and research headquarters based in the UK. The company
invents, develops, manufactures and markets products to improve
human health, nutrition and quality of life around the world.
The company employs 32,100 people, of which over 7,000 are scientists,
working in three separate businesses; Pharmaceuticals, Agrochemicals
and Specialties. Over 94 per cent of Zeneca sales are outside
2. Zeneca Agrochemicals is the international
business that develops chemical and gene based products for the
agricultural sector; and were the first company to successfully
launch in the UK a food (tomato puree) produced from genetically
modified (GM) fruit. The business had a turnover in 1997 of £1,613
million. Zeneca's agrochemical business is the third largest in
the world. In addition, Zeneca is co-owner of Advanta, the world's
fifth largest seed company with its headquarters in The Netherlands.
3. Innovative research, coupled with effective
product development and marketing skills, is the foundation for
Zeneca's present and future success in agriculture and food. Zeneca
Agrochemicals has 1,200 people directly involved in research and
development, and this year is investing £140 million in this
activity. To achieve the critical mass necessary for productive
research most of the investment is based in the UK.
4. Zeneca's research strategy is based on the
philosophy of Integrated Crop Management (ICM)the
use of the appropriate combinations of agronomic, chemical and
genetic techniques, to optimise food production and crop quality.
ICM is an approach that enables the farmer to conserve and enhance
the environment, whilst producing safe and wholesome food economically.
In farming, like in other business enterprises, commercial success
is dependent upon making the best economic use of available resources.
Getting the balance right is the fundamental tenet of this agricultural
5. Biotechnology plays a major role in Zeneca's
research programmes. For example, biotechnology is critical to
the invention and evaluation of new generations of superior chemicals,
new crop varieties resistant to pests and diseases, and plants
with desirable traits such as enhanced yield and nutritional characteristics.
6. We believe that biotechnology has the potential
to have a profound and beneficial impact on agriculture and the
environment. Biotechnology will contribute to the development
of sustainable agricultural systems in developed and less developed
economies and hence increase agricultural productivity to help
meet the challenge resulting from the projected population increase.
The underlying science supporting biotechnology is describing
the genetic basis of all aspects of plant growth, metabolism and
development. Plant genome descriptions will give a full catalogue
of useful genes and allow focused efforts to catalogue and conserve
biodiversity at the gene and species level. Genetic improvement
through knowledge-based breeding or through genetic modification
will be enhanced by these genome programmes.
7. The first products developed through use
of genetic modification are ones where single gene traits are
providing major effects in crop protection (herbicide selectivity,
resistance to insect attack or quality changes). As the technology
develops, then more complex gene combinations will result which
give improved effects. Integration of chemical and genetic effects
to provide crop protection solutions is an area where we see great
opportunities, particularly in the control of fungal and insect
attack. On the same timescale, the knowledge of the fundamental
makeup of plants and their pests and diseases will allow the more
rapid identification of superior (cost effective with even lower
environmental impact) chemicals for crop protection. The end uses
of crops are enormously varied. Biotechnology will allow in the
future the better tailoring of the raw material attributes of
the crop to the specific desired end use, be this for optimum
animal or human nutrition, or the production of specific feedstocks
for industrial processes on a renewable basis.
8. The UK was a pioneer in the development and
implementation of regulations which cover biotechnology; this
is generally considered one of the reasons for the success of
biotechnology in UK academia and industry. Zeneca feels that it
played its part in the development of the regulatory strategy.
These regulations were science based, carefully thought out and
implemented. They have been respected and copied around the world.
Zeneca was generally very impressed with the manner in which both
the environmental and food regulations were applied in the UK.
However, at the European level despite very positive statements
on the importance of biotechnology for European competitiveness
and funding of research, the regulatory situation is a cause for
9. To be successful Zeneca has to plan its research
at least 10-20 years ahead. This is because of the long invention
and development times in agriculture, due partly to the need to
evaluate the products under different agronomic conditions and
partly the time needed to gain regulatory approval. For example,
we are just now launching Amistar one of a new generation of fungicides.
Amistar is based on a natural product and has taken seven years
to go from discovery to the market (the average period for an
agrochemical is 8-10 years). We are however, already evaluating
strategies for using biotechnology to control leaf disease in
bananas and potatoes. The first field trials of the genetically
modified banana plants will take place this year, but it will
be another six years before we can offer disease resistant plants
to the farmer as part of an ICM package. Regulatory uncertainty
is a major issue in research planning.
10. The regulatory problems we face today are
indecision and a lack of leadership at the European level. This
is having a negative impact upon our business both directly and
also indirectly via the damage it is doing to consumer perception.
The main problems which affect our business are discussed below.
11. Failure to develop the European regulations
at the same pace as the technology has progressed. For example,
the UK has had novel food regulatory guidelines for many years.
It was the existence of these well respected guidelines which
enabled us to launch the GM tomato puree in 1996. However, it
was only last year that the European Novel Food Regulation became
law, yet it was obvious for many years that such a regulation
would be needed. We believe that discussions on this regulation
started at the European level in 1990. At the time of preparing
this evidence there are still no clear European Union labelling
guidelines for genetically modified foods. The industry has had
to develop its own voluntary guidelines without any consistent
guidance from governments; the resulting confusion leading to
a lack of consumer confidence. Meanwhile the USA has in place
a regulatory process which is widely respected by both industry
12. Potential conflicts between different
regulations. The European regulation defining organic products
(2092/91) was carefully framed to "increase credibility with
consumers" and to "ensure fair competition between producers".
The regulation, which covers imports, as well as crops grown within
the EU requires that "95 per cent of the ingredients"
are obtained in accordance with conditions laid out in the regulation.
In June this year the European Council of Ministers will vote
on amendments to this regulation which states that "in organic
production, genetically modified organisms, parts thereof and
products derived therefrom must not be used in products labelled
as from organic production". If this is interpreted as 100
per cent exclusion of any pollen from a genetically modified crop
then this badly framed amendment will damage both the credibility
of the organic label and the viability of European agriculture.
13. A lack of transparency, not only
for the applicant but also for the consumer, in decision making.
As a company we welcome any attempt to increase transparency.
14. The scientific base of the regulations
is being diluted by political compromises. Society handles uncertainty
by using the principles of risk assessment and then giving this
advice to our elected representatives and leaders for a decision.
The questions on biotechnology asked by the European and American
regulators are very similar, which is not surprising since they
are based on a scientific approach to risk assessment. To ask
the regulator to provide a political, commercial, sociological
or ethical decision is both a misuse and abuse of the scientific
risk assessment approach.
15. The sound bite approach to risk assessment.
In our view it is as wrong to state that all applications of biotechnology
are safe, as it is wrong to state that all applications are dangerous.
An important component of risk assessment is the case by case
approach. The universal genetically modified crop plant does not
exist. Each species and inserted trait must be dealt with independently.
For example, the likelihood of outcrossing from varieties of tomato,
maize, sugar beet and oil seed rape are totally different and
must be evaluated differently. Similarly, the hazards of particular
traits that may be inserted must be evaluated independently. It
is scientifically dishonest and misleading to decision makers
and the public to argue that the risks posed by crop plants with
totally different agronomy and ecology are the same.
16. A conflation of different issues.
Genetically modified crops have become the lightning rod for a
debate on many other issues, such as agricultural reform, WTO
and biodiversity. Genetically modified crops are usually only
a small component of these discussions, but become the focus for
the debate because that debate is not being held, or perceived
as being held, elsewhere.
17. International trade. As at
the European level, the regulatory implications of the transfer
of GM seeds and plants between countries (and hence international
trade) has been apparent for some time. The committees advising
the Dutch and UK governments on the release of GMOs in late 1994
proposed guidelines to cover this issue. They in time evolved
to become the UNEP "International Technical Guidelines for
Safety in Biotechnology". We are now debating the BioSafety
Treaty under the Rio Convention (which has not been ratified by
the USA). Unhelpful trade disputes are the inevitable consequence
of these different regulatory processes.
18. Direct cost and delay is the first
result of this lack of regulatory leadership. There is a no clear
regulatory route map for either academia or industry to follow.
In preparing the case for a development decision on a product,
the time and cost taken to achieve regulatory approval is one
of the most critical factors. It is simply not possible to define
this time and cost for a product entering the European Regulatory
System. The time taken for the regulatory approval of genetically
modified tomatoes indicated this issue. These regulatory applications
are essentially for the same product.
|Type of application||Submission date
|USA to grow and process||February 1995
|USA human consumption||September 1994
|UK human consumption||August 1994
|Canada human consumption||December 1995
|Mexico to grow and consume||June 1996
|EU to grow and process||November 1996
||still no decision|
|EU human consumption||March 1998
In the absence of an appropriate EU regulation it was only
possible to launch the product in the UK which has a long history
of regulatory guidelines for novel food. After receiving the regulatory
approvals the product went on sale in Safeway and J Sainsbury
stores on 5 February 1996. The cans of puree are sold next to
the regular product which is produced from fruit grown in Italy.
The transgenic tomatoes were grown in California. There is still
no regulatory approval to grow and process these tomato plants
19. Effect on innovation and UK competivity. The lack
of predictability means that some of our most senior staff have
to devote their time to steering the company through this state
of regulatory chaos. Small companies, universities and research
institutes do not usually have these skills available and therefore
tend to concentrate on less contentious, though arguably less
innovative, areas. In addition, potential investors are naturally
concerned about uncertainty in product development. In our experience
there is in the EU, compared with the USA, a dearth of entrepreneurial
SMEs in the agricultural and food areas. One reason for this we
would suggest is the regulatory system.
20. Public acceptance. The confused regulatory system
does nothing to build the trust of the consumer in the regulatory
system, those who administer the regulatory process, or the underlying
political system. Without the political leadership to develop
and defend the regulatory system, the way is open for the
present spate of totally unjustified claims about safety to be
made. The success of the genetically modified tomato puree sold
in the UK stores of Safeway and Sainsbury was, we believe, partly
because of benefits for the consumer, regulatory approval from
HMG, the provision of information and clear (voluntary) labelling.
The success shows that the European consumer will accept these
biotechnological products provided they are treated with respect.
29 May 1998