Annotated Bibliography Entry
Reference: EC
Research 2001
Title: EC-Sponsored Research on Safety of Genetically Modified Organisms: A
review of results
Authors: Kessler, C and Economidis,
I. (eds)
Publisher: European Commission,
Research DG, Rue de la Loi/Wetstraat 200, B-1049 Brussels.
Publication details: A printed
version of the review (EUR 19884 - © European Communities, 2001) may be
obtained from the editors, Charles.Kessler@cec.eu.int
/ Ioannis.Economidis@cec.eu.int
Summary
Introduction
Fig
1: Relationship between GMO safety research, regulation & practice
Table
1: History of EC-Supported GMO Safety Projects
Table
2: Thematic research areas for EC sponsored research (1985-2000)
Foreword
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Summary
This report provides a comprehensive
review of the results of EC-supported research into the safety of Genetically
Modified Organisms. It presents research carried out under successive EC
Framework Programmes for Research and Technological Development from 1985
(Biotechnology Action Programme) to 2000 (Fifth Framework Programme). Over
this period, the EC sponsored 81 projects on various aspects of assessing the
safety of genetically modified organisms (see Table 1). The projects involved over 400 teams
form many different countries, and a wide range of disciplines. The EC
contributed about Euros 70 million. Summaries of the results of each of the 81
projects are available on the review website.
Introduction,
Philippe Busquin, EU
Research Commissioner
Recent
decades have seen massive growth in our knowledge in Life Sciences. This
presents many new opportunities for applications, some of them raising issues
for public policy and/or public interest and concern. European Community policy
since the start of its Framework Programmes for Research and Technological
Development has been to accompany Life Sciences research with research on safety
aspects of the new technology generated.
Of
particular importance in this context is the use of Genetically Modified
Organisms outside contained facilities. Consequently, GMO safety research has
been supported in successive Framework Programmes from 1985 to the present day.
The pattern of development of this support is illustrated in the table below,
which shows that over this 15-year period 81 projects have been supported. These
projects have involved over 400 teams from many different disciplines and
represent a combined Community financial contribution of about €70 million.
Summaries of all these projects are contained in this review.
In today's
debate on the use of GM technology in agriculture, food and the environment,
it is sometimes suggested that we lack knowledge on possible impacts and how
to handle them. The primary objective of this review is to demonstrate how the
EC has tackled this need; to show that it has made a sustained effort,
building up a sizeable community of researchers and contributing to the
world's fast-accumulating knowledge and experience in the field. The second
objective is to communicate these results, including an inventory of the
research groups that generated them. In this field it is particularly
important that scientists in different countries know who else is working on
their topic, so that they can collaborate to gain efficiency and added value.
Research
results can resolve uncertainties and provide a sound basis for risk
management and science-based regulation (where necessary), through
pre-normative research, and lead to the establishment of best practice in a
constantly evolving way, as illustrated in Figure 1. The overall result of
this tripartite system has to be communicated to all concerned, particularly
to the general public and to political groups, some of whom have shown
sustained and sometimes critical interest in the development of GM technology
and its applications in various sectors.
Particular features of the projects described here are that they are carried
out on a joint basis by multinational consortia of scientists, and that their
results are usually submitted for publication in peer-reviewed journals. In
this respect they complement biosafety research carried out in national
programmes and the testing work carried out in fulfilment of regulatory
requirements.
In support of,
and in order to provide an input to, its research activities on biosafety, the
EC has participated in OECD committees, helped organise a series of
international conferences on biosafety research, and set up a Task Force on
Biotechnology Research with United States research agencies. To canvass a wide
range of opinions on GMO research in general and to sharpen programme
planning, a workshop entitled "GMO Research in Perspective" was held
in Brussels in September 1999.
Biosafety research over the past
quarter-century has played a key role in accompanying the development and
diffusion of modern biotechnology products and applications, in health care,
agro-food and the environment. The benefits of the more precise methods are
becoming clear, but as always with innovations, the precautionary approach
demands that uncertainties and conjectural risks be addressed by corresponding
research. The results of the research and growing practical experience,
feeding into regulatory and risk management policies, have enabled these to be
regularly adapted to facilitate safe innovation, thus contributing to the
excellent safety record to date, and providing a basis for continuing public
confidence in the technology and its products.
This review includes all EC-supported
projects explicitly targeting GMO safety research; it also includes a few
others that may focus on some other subject but which contain important
elements of or implications for GMO safety research. Projects have been
grouped for convenience into eight thematically based research areas, each
with an introduction, providing an overview of the results, trends and issues,
written by a scientist prominent in the field. Most reports have been written
by project co-ordinators and are their author's responsibility. In a few
cases, especially among the earlier projects, reports have been taken from
earlier published material. The eight themes are shown in Table
2.
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Figure 1: Relationship
between GMO safety research, regulation and practice: synergy and feedback
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Table
1: History of EC-Supported GMO Safety Projects
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Foreword
J.E. Beringer, School of Biological Sciences, University
of Bristol (UK)
“GMOs are
unsafe and must never be released into the environment.” “We don’t know
enough about GMOs to risk releasing them – what is being done about this?”
“Why doesn’t someone do something to understand what the risks of GMOs
are?” We have all heard these and related comments about GMOs, which have
been used by people opposed to the commercialisation of GMOs to demand that
“the precautionary principle” be used to halt their use in agriculture.
They have encouraged and exploited public unease very effectively because most
people are unaware that biosafety research is being done and, with the
exception of GM vaccines and other medical uses, there has been very little
direct public benefit to counteract perceived risks.
The success of the anti-GM lobby is clearly demonstrated by the fact
that in much of Western Europe governments have appeared very ambivalent. They
have invested in biotechnology and promoted its advantages, while at the same
time they have tacitly accepted delays in the regulatory system for marketing
GMOs to ensure that their commercialisation for agriculture has been impeded.
The fact that this behaviour has been primarily directed towards satisfying
perceived concerns of potential voters, as opposed to providing leadership, is
an issue that needs to be debated elsewhere.
European
governments have most certainly not been helped to appear dispassionate
because state-owned plant breeding institutions have been sold to the private
sector, thereby strengthening the hold of multinational agrochemical companies
over food production. One does not need to be a rabid eco-terrorist to have
doubts about the wisdom of so much control of the food chain falling into the
hands of multinationals whose financial strength is greater than that of many
of the world’s developing countries. To make matters worse, a major public
health scare (bovine spongiform encephalopathy (BSE)) has been added to this
mixture of distrust, confused leadership, and lack of knowledge. Such was the
position in Europe as it approached the end of the 20th century. It is against
this background, that we need to consider the relevance of the research
results published in this volume.
Throughout
history ignorance has been a major driver for apparently irrational and
backward looking behaviour, for the simple reason that most humans feel
uncomfortable when confronted with things and issues they do not understand.
It is so much simpler to condemn something than to attempt to understand it.
We have a ‘fine tradition’ in Europe of burning those people we do not
understand, whether they be witches or heretics, for it is much easier to do
this than to try and understand them. It is important to recognise that not
far below the surface of us all are emotions that have evolved over many
millennia, which are ill adapted to managing the enormous technological
changes of the 20th century. We have not had time to evolve brains that can
easily handle the quantity or complexity of so many issues facing society
today.
Furthermore,
our educational systems are struggling to come to terms with the need to link
scientific and sociological education to provide future citizens with the
ability to make knowledge-based risk assessments. Traditionally, strong
leadership has provided people with assurance that changes are safe and
desirable, but it is becoming increasingly obvious that as general levels of
education improve the public becomes less willing to accept authority. I
applaud the change, but it carries within it the problems we face in deciding
how to communicate the risk/benefit analysis of the use of new technologies.
Leaving industry to come forward only with new technologies that are perceived
to be advantageous despite apparent risks, such as mobile telephones, is not
the solution. It would preclude the introduction of technologies that are less
harmful than present ones, but are not deemed to be of value to individuals.
To
Is it all doom and gloom? It most certainly is not, as this compilation of
results from 80 EC-supported projects on GM safety research demonstrates. One
of the ‘best kept secrets’ during the last few years of acrimonious
discussion about GMOs has been the enormous body of research being conducted
in Europe and elsewhere that is directly relevant to risk assessments. For
those of us who have been involved in running GM safety committees in Member
States there has been a steady stream of research results that have enabled
our committees to improve their ability to make risk assessments and recommend
safe conditions for the release of GMOs. Even a casual glance at the contents
of this publication will confirm that over the last decade the EC has been
very effective in identifying important issues and funding appropriate
laboratories in which relevant and useful results can be obtained to enrich
our understanding of the issues confronting us. A very valuable example has
been the research projects on pollen flow and fertilisation in plants, which
have greatly enhanced knowledge of the probabilities of cross-pollination of
adjacent crops and wild relatives of crop plants. There should not be a GM
regulatory system in an EU Member State that has not modified its activities
to take into consideration the implications of research derived from
EC-supported programmes.
A decade of
research has been done and millions of euros have been spent, but the anti-GM
lobby’s agenda has hardly changed at all. They profess still to be concerned
that we have insufficient knowledge and that no GMO should be released until
we can predict with certainty what it, and the cloned genes within it, will do
in the environment. Does this demonstrate a failure of the EC programmes? Were
the programmes poorly targeted? Was the work unsatisfactory, or is far more
work needed? The programmes most certainly have not failed scientifically. In
retrospect, one could argue that sociological issues should have been
included. For example, how many of us believe that “if only the public
knew the issues they would surely understand why we believe that properly
tested GM crops and food are safe”. I certainly did. Unfortunately, this
belief is almost totally wrong – if indeed a belief can be wrong. The reason
why it is wrong is that we confuse knowledge with understanding. Full
knowledge of the genetic and biochemical changes arising from a gene-cloning
event is useful and certainly helps risk assessments for food safety. However,
our understanding at the molecular level (and indeed biological) of the
factors that will change the ecology of an organism are very poor indeed. If
one assumes that existing crops and foods derived from them are safe, as most
people do, GM crops and foods will, for a long time to come, have an aura of
uncertainty associated with them. The fact that we do not understand why the
enormous changes to genomes that occur during traditional plant breeding do
not lead to health or environmental problems with new crops, is neither known
by the general public nor taken into consideration by opponents of GMO
release. Indeed, if we responded to demands to avoid unpredictable risks to
the environment we would have to stop traditional plant breeding and the
introduction of different varieties and species of crop plants.
With respect to
my comments above about sociological issues, it is here that I would criticise
our funding of research over the last decade, but do so with the benefit of
hindsight! The programmes have been about biosafety and have concentrated
rightly on obtaining scientific understanding, which has benefited risk
assessment and furthered our knowledge of basic science. However, in
technological societies an assessment of risk needs to include public
responses and should take into consideration possible long-term issues that
may arise as a result of the commercialisation of new technologies. For GMOs
we have concentrated almost solely on risks to human safety and harm to the
environment arising from the GMO itself. However, the much-derided problem of
secondary impacts that may result from the displacement of existing, and
particularly traditional, practices has been largely ignored. There have been
few voices louder than my own in criticising the demands for a “Fourth
Hurdle” for GMOs, but where was the research to support or overturn
criticism of it? It is surely time that we paid more attention to the impact
of technology on societies, because if we do not the rate of progress of
technology will greatly outstrip our ability to handle its impacts. We benefit
from change, but is every safe development to be accepted regardless of how it
might change our perception of ourselves and the world around us?
The problem of
how to proceed with the development and commercialisation of GMOs confronts us
with very difficult policy decisions. Should we conduct research to facilitate
marketing, or to develop understanding? If the first is our priority, the
projects to fund would be those that identify risks and uncertainties
associated with conventional plant breeding and different agricultural
practices. The public might find it easier to understand relative risks if
there was a greater understanding of the enormous unpredictability of
conventional plant breeding, but would they benefit from the increased
uncertainty about food safety? The EC research programmes have taken the
correct course of funding high-quality basic science and we should not be
deflected from our objective to develop increased understanding. Our role as
scientists is to obtain and interpret information so that governments and
their advisors are in the best possible position to identify the best route
forward. It is important to remember that EU countries are part of a larger
world in which the major trading partner is the USA – a country in which
concerns about the safety of GM crops are so much less that various categories
have been deregulated. World trade rules require governments wishing to
control the movement of products to provide appropriate scientifically-based
reasons for interfering in free trade. Whether one agrees with outspoken
opposition to GMOs within Europe or not, we can hardly expect farmers
elsewhere in the world to segregate crops that are not subject to regulatory
control in their own country without providing very compelling reasons for so
doing.
The EC
programmes have provided a very good basis for moving ahead in the 21st
century with an increased awareness of possible problems and knowledge of
relevant science. I have concentrated my comments on GMOs because concerns
about their safety have provided the impetus for funding the research. We
should realise that environmental harm is not something that will happen only
if we use GMOs, but is something that is happening all around us as a
consequence of human activities that predate GMOs. Our exploitation of natural
resources and the increasing intensification of agriculture cause great harm
to the environment and biodiversity. If we are to halt and redress this harm
should we not concentrate research on how to satisfy the needs of humans,
while at the same time respecting and protecting wildlife and the environment?
Almost all such research would be directly applicable to the need to assess
the safety of GMOs. It would also have the enormous benefit of leading to
regulatory systems in which all activities would be subject to appropriate
risk assessment. Such funding would be entirely relevant to the needs of
regulatory bodies and those making GM products. It would also tackle the real
causes of environmental harm and should, in time, lead to a compilation of
research results that are at least as useful as those published here.
From 1992 to
1999 Sir John Beringer was Chair of the UK Advisory Committee on Releases to
the Environment (ACRE).
(1) Editors' note: Over the past decade EC research
programmes have supported many studies, workshops and other actions addressing
broader socio-economic aspects and implications of biotechnology. Currently,
the Fifth Framework Programme's 'Key Action' approach explicitly seeks to link
research projects to broader socio-economic missions of European relevance.
For details see the "Biosociety" website at: http://biosociety.dms.it/
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Further information
Web site: http://europa.eu.int/comm/research/quality-of-life/gmo
New Genetics, Food &
Agriculture: Scientific Discoveries - Societal Dilemmas