FAST
SALMON AND TECHNOBURGERS
Copyright © The National Committees for
Research Ethics 1997
The National Committees for Research Ethics
The Oslo Research Park
Gaustadalléen 21
N-0371 Oslo
Norway
Phone: +47 22 95 87 80
Fax: +47 22 95 84 92
E-mail: mail@etikkom.no
Editors: Per Sandberg and Nina Kraft
Layout: Hilde Storvik
Translation: Peter Bilton, Oslo
The National Committees for Research Ethics,
NEM, NENT and NESH are independent bodies with mandates from the Ministry of Education,
Research and Church Affairs. NEM deals with medicine, NENT with science and technology,
and NESH with social science and humanities.
The Committees are to function as watchtowers,
sources of information, and advisers in research ethical issues. The Committees shall
submit reports and propose guidelines of research ethics. They shall also inform
researchers, the administration and the public of current and potential questions of
research ethics, and promote informed discussions in society of ethical questions relating
to their areas of responsibility. Papers published in the Committees' publication series
do not necessarily reflect the views of the Committees, but are the responsibility of the
authors.
Further information about the Committees can be
found at
The Biotechnology Advisory Board is an official
independent advisory body appointed by the Government. The Board's mandate covers
biotechnology and gene technology in relation to humans, animals, plants and
micro-organisms. The Board shall evaluate principles and general issues in connection with
activities in biotechnology, and put forward proposals for ethical guidelines for such
activities. It shall also make recommendations in cases that are dealt with under The Gene
Technology Act and The Act Related to Application of Biotechnology in Medicine. The Board
shall also inform the general public of biotechnology.
Further information about the Board can be found
at internet: http://www.bion.no
The Biotechnology Advisory Board
P.O. Box 8027 Dep
N-0030 Oslo
Norway
Phone: +47 22 24 87 91
Fax: +47 22 24 27 45
REPORT BY THE LAY PANEL
The initiative leading to a layman's conference
was taken by the National Committees for Research Ethics and the Norwegian Biotechnology
Advisory Board, which saw a need to include non-experts in order to obtain the views of
ordinary people on the genetic modification of food.
The panel consisted of 16 people, 8 men and 8
women, aged from 18 to 72, from various parts of the country and with different
backgrounds. Members were not to have close links with occupations or organizations with
established policies in this area.
In its work, the panel was advised by Professor
Gunnar Handal, of the University of Oslo's Department of Educational Research.
The panel held two preparatory meetings in
addition to its concluding conference, at which experts delivered statements and answered
questions, and the panel presented its report.
The questions published in the report were put
to the experts so that the panel could obtain more information on the subject. The answers
- contained in the statements and given in response to the questions - formed the basis of
the views the panel has formed on different matters, although the report does not
necessarily answer each of the questions directly.
The aims of the work were to give coordinated
advice on genetically modified food to politicians, authorities and the food industry, to
establish a forum for
dialogue between experts and non-experts, and to
contribute to an all-embracing and well-informed public discussion of the subject.
The panel hopes that the present report will
contribute to the realisation of those aims.
The panel found its task very interesting,
instructive, stimulating and enjoyable.
It is the panel's opinion that there is no need
for genetically modified food in Norway today, because the selection, availability and
quality of ordinary food are satisfactory. Too many uncertain factors attach to genetic
engineering in this connection. This also appeared from the statements by the expert
panel.
The panel points out circumstances to which
attention ought to be paid if developments nevertheless move in that direction.
The conclusions presented later in the report
should be seen in the light of this statement of principle.
In the panel's view, the most important measure
that can be adopted in this area is probably to contribute to the education, where the
genetic engineering of food is concerned, of a well-informed, aware and critical public.
This could have a beneficial effect, among other things on the shaping of policies, the
drawing up of rules, practice with regard to decision-making and controls, and influence
on consumers.
The report is presented in eight main sections.
The lay panel:
Karl Erik Birkeland, 20, student, Ålesund
Julia Bjørnstad, 19, student, Moss
Helge Bjørnestad, 59, businessman, Nesttun
Yvonne Briton Denneche, 25, executive secretary,
Oslo
Klaus Magnus Johansen, 18, school pupil,
Mjøndalen
Irja Johanson, 72, pensioner/insurance agent,
Jar
Rita Lunden Halseth, 35, cook, Kristiansand
Torger Richter Jenssen, 50, proof-reader, Oslo
Solveig Bull-Njaa Larsen, 54, college lecturer,
Stavanger
Kent-Willy Pettersen, 26, coordinator, Trøgstad
Magne Rustad, 40, police officer, Hønefoss
Åsmund Selfors, 65, teacher, Selfors
Einar Spjelkavik, 37, builder, Trondheim
Else Stjernstrøm, 47, head of department,
Tromsø
Tone Ystanes, 34, housewife, Skjetten
Solfrid Aamot, 55, project team member, Oppdal
Professor Gunnar Handal, Department of
Educational Research, University of Oslo (facilitator)
The expert panel:
Helge Klungland, Department of Animal Science,
Norwegian University of Agriculture, Ås
Askild Holck, Matforsk - Norwegian Food Research
Institute, Ås
Guri Tveito, the Ministry of Environment, Oslo
Hilde Kruse, National Veterinary Institute
Ragnar Fjelland, Centre for the Study of Science
and the Humanities, University of Bergen
Nils Uddenberg, Swedish Institute for Futures
Studies, Stockholm
Åse Fulke, Norwegian Food Control Authority,
Oslo
Stine Wohl Sem, Consumer Council, Oslo
Odd Arne Rognli, Department of Biotechnological
Sciences, Norwegian University of Agriculture, Ås
Rune Blomhoff, Institute for Nutrition Research,
Oslo
Marte Rostvåg Ulltveit-Moe, Nature and Youth,
Oslo
Torben Hviid Nielsen, Centre for Technology and
Culture, University of Oslo
Reidar Almås, the Centre for Rural Research,
Norwegian University of Science and Technology, Trondheim
Claus Christiansen, Danisco Biotechnology,
Copenhagen
Marit Bjerkås, Norwegian Co-operative Union and
Wholesale Society, Oslo
1 How are genes modified?
1a How precise is genetic engineering
technology?
1b Is the process irreversible, for instance if
genetically modified organisms (GMO) are deliberately released into the natural
environment?
1c What is the difference between traditional breeding/selective breeding and genetic
engineering?
1d Which advantages/disadvantages does genetic
engineering entail with regard to the speed of progress?
2 Which categories of genetically engineered
food exist?
2a To what extent do the end products contain
modified genes?
3 Why is gene modification a topical research
subject?
In genetic engineering, gene modification is a
technique which principally consists of isolating a gene with a desired characteristic and
then transferring that gene to another organism. Although the technique was only developed
a relatively short time ago, it has developed by leaps and bounds since 1973, when
scientists first succeeded in transferring a gene from one species to another.
The technique used to find and isolate a gene
which codes for a desired characteristic has proved to be precise. The introduction of the
isolated gene into a host, on the other hand, is very imprecise. To make it easier to
distinguish hosts which have incorporated the new gene in the desired way, marker genes
are introduced at the same time. Thus it is easy to cultivate only those organisms which
have incorporated the gene in question. But because of the difficulty of controlling just
where the injected gene locates itself in the DNA chain, it is not possible to predict all
unwanted effects.
Once a gene has been introduced into an
organism, it can in practice not be removed. To stop the effect, the organism containing
the modified gene, and any "offspring" it may have had, must be destroyed. This
can be done for instance by making the organism sterile or making it dependent on a
particular environment.
Like traditional breeding, genetic engineering
is based on the selection of organisms. Nevertheless, it is important to be aware of
certain differences. In theory, genetic engineering opens up the possibility of crossing
all the boundaries between different species, which is impossible in traditional breeding
and breed improvement.
Like all technologies, genetic engineering
offers both advantages and disadvantages. Quicker results are an example. They can on the
one hand provide us with a great deal of knowledge in a short space of time, but on the
other they involve the risk of not having an overall view. The urge to begin using a
technique as quickly as possible (unwillingness to wait for a better technique) increases
the risk of unwanted long-term effects.
The following categories of genetically
engineered food exist (examples in italics):
* Food consisting of genetically engineered
organisms:
genetically modified tomatoes
* Food containing genetically engineered
organisms:
soup powders containing genetically modified
tomatoes
* Food produced using genetically modified
organisms which remain in the product:
bread baked using genetically modified yeast
* Food produced using genetically modified
organisms but which no longer contain modified genes:
soya
oil made from genetically modified soya beans
Why is genetic engineering a topical research
subject?
* The technology has been discovered and the
techniques are available
* There are many possibilities
* The subject affects all groups in society
* The field offers opportunities for high
financial profits
The panel recommends:
* That the focus of research be shifted from
basic research to deliberate release and its effects
* That the focus of basic research be put on
problems relating to the introduction of genes into organisms
4 What genetically modified products are
available today on the Norwegian, European and international markets?
4a What products are being tested (in
laboratories and deliberate release experiments) with the aim of reaching those markets?
5 Both basic and applied research are being
carried out in this area. Who runs and finances such research? Are those engaged in the
various types of research cooperating?
6 In the field of genetically modified food,
research is being carried out under both private and public auspices. To what extent does
Norway/should Norway exercise central control of such research?
7 Which Norwegian statutes and rules currently
regulate research into and development, production, imports and distribution of
genetically modified foods?
7a What need is there to update statutes and
rules?
7b Is such updating currently taking place?
7c How far, and by what means, is it possible to
influence national legislation through special interest organizations?
8 What international laws/rules are currently
under preparation?
8a To what extent will international legislation
influence Norwegian rules (legislation) - and vice versa?
8b What will be the results of Norwegian
legislation which is "stricter" than the international rules?
9 How much scope does the food industry have for
taking public attitudes into account when marketing genetically modified food - and does
it do so?
Several products are currently in use in other
countries, such as tomatoes, corn, soya beans, papaya, squash, potatoes, and rape seed. In
addition, applications for approval of a number of species have been submitted both in the
EU and in Norway.
According to the experts, there are currently no
GMO products on sale in Norway.
Norwegian authorities have four main sets of
rules to relate to where regulation of genetically modified organisms is concerned:
1. The Act relating to the production and use of
genetically modified organisms (The Gene Technology Act) (1993)
2. EU Directives concerning deliberate release
and contained use
3. The UN Convention on biodiversity
4. The WTO Agreement
The Gene Technology Act can be said to cover
today's situation, but probably not tomorrow's.
The present Gene Technology Act does not cover
all forms of GMO products, for instance processed products.
It is our understanding that the Norwegian
authorities are waiting to see what rules the EU issues, but where EEA Directives are
concerned, Norway can exercise a veto. Norway has experts on various international
committees who urge Norway's views on GMO products.
European consumer organizations cooperate on
food questions, among other things so as to have an influence on the EU Commission, the EU
Parliament, etc.
The following example can serve to illustrate
the problem which arises if Norwegian laws conflict with imports of foreign goods:
The EU has refused to accept imports from the
USA of milk products produced using the genetically modified growth hormone BST, but is
applying pressure to have the refusal reversed. In the next instance - and in other cases
- such pressure may be directed against Norway.
The panel's opinions:
* By virtue of Section 1 on the purpose of the
Gene Technology Act, Norwegian legislation differs from legislation in other countries. In
our opinion, the concepts socially justifiable and sustainable development must be upheld.
The definitions of the two concepts need to be gone into more thoroughly.
* Norway must be prepared to exercise its right
of veto to prevent imports of GMO products into Norway. In the event of imports, Norwegian
authorities must emphasise sustainable development and usefulness to society.
10 What health hazards and health gains, if any,
does genetic modification of food entail?
10a Will genetic engineering lead to
nutritionally better products, and will this be given priority?
10b Will genetic modification possibly replace
harmful artificial additives?
10c What do we know about the possible effects
of genetically modified food on the genetic structure of human beings?
11 In what ways can genetically modified food
involve advantages/disadvantages in relation to allergies?
12 Genes which lead to resistance to antibiotics
are used as markers in genetic engineering. Such drugs are also in international use in
medicine and veterinary medicine. Is there a risk of increasing numbers of resistant
bacteria strains, and if so how can this be avoided?
13 How far should we rely on medical guarantees?
13a Are scientists given enough time in which to
reach certain conclusions concerning effects on coming generations?
13b Are scientists in a position to ask the
"right" questions?
We can see that this technology opens up
important opportunities for improving the nutritional content of food, and our impression
is that this is emphasised in the debate on genetically modified food, but on the basis of
the work to date we cannot see that this area of research has been given priority.
The use of additives is one area in which
genetic modification may have beneficial effects on food quality. If the keeping quality
of a food is improved, there may be less need for preservatives. But this does not appear
to be a prioritized research field, either.
Allergies are often mentioned in connection with
genetically modified food. One can remove the proteins which cause allergies, but in
transgenic plants an allergenic gene may have been introduced which may have serious
consequences for persons with allergies.
Genes which lead to resistance to antibiotics
are used as markers in genetic engineering. There is broad agreement among experts that
the use of antibiotics in that context may accelerate the development of resistance to
antibiotics. Alternative marker genes have been developed which ought to be used instead
of antibiotic resistance genes.
It is not unlikely that the use of antibiotics
as marker genes in food may have a harmful effect on the intestinal microbial population
in humans. That the use of genetically modified food may have other harmful effects on the
body is regarded as unlikely.
This will be confirmed or disproved in time.
Whether or not the time-spans allowed for such experiments today are generous enough is
hard to tell with any certainty, since research in this area is relatively new. But we
have every reason to be cautious.
Seeing that researchers are creative and curious
by nature, there is a good chance that they will come up with the right questions. Of
course there are limits here, in terms of knowledge, time and imagination.
As to whether or not medical guarantees can be
relied on where harmful effects, if any, of genetically modified food are concerned, the
answer is that medical guarantees of that nature are impossible to give, in this as in
other fields.
The panel's recommendations
* To enable consumers to derive the greatest
possible benefits from food-related genetic engineering, priority should be given to
improving the nutritional content.
* Researchers should concentrate more on what
may happen to our bodies when we eat genetically modified food. We know too little about
whether effects over long periods of time can have consequences for genetic structures.
* Genes which lead to resistance to antibiotics
must not be used. There are alternatives.
* We must be prepared to wait and allow
scientists the time they need to acquire more knowledge.
* To increase the possibility that they will ask
the right questions, scientists must listen to the world around them, for instance by
participating in the ongoing debate in society and meeting various other participants.
We accept that genetic engineering research into
food can open up opportunities for beneficial advances. But we see so many reasons for
uncertainty that we have decided for the time being to reserve our position.
14 When genetically modified organisms are
released, is it possible to prevent them from spreading and/or cross-breeding with
"natural" plants, micro-organisms and animals?
14a May the spread of released, genetically
modified micro-organisms, plants and animals disturb the ecological balance?
14b What may the consequences be of the
uncontrolled spread of micro-organisms, for instance those which are resistant to
antibiotics?
15 How is it possible for transgenic plant
species to lead to less use of harmful weedkillers and pesticides?
15a What proportion of research is directed at
the development of plants which are resistant to sprays, as against development of plant
species which are resistant to disease and damage?
16 Genetically modified plants may make it
possible to cultivate plants in new environments, shortening the distance from the
producer to the consumer. On the other hand, foods with better keeping qualities can be
transported long distances. Will transport, and the energy consumption and pollution that
goes with it, increase or decrease?
Nature itself is dynamic; the environment around
us is constantly changing, but the changes may only become noticeable over time. In
genetic engineering we see the possibility of rapid and extensive changes in the living
components of ecosystems (micro-organisms, plants and animals). At the same time, we need
to consider every new technology in relation to existing environmental problems. We
accordingly believe that ecological considerations are very important in the debate on
genetic engineering.
It is difficult to predict what the long-term
consequences may be of deliberately releasing transgenic species. There appears to be a
reasonable degree of agreement that if plants and animals - for instance salmon - are
released it is not possible to prevent spreading or cross-breeding with other species, but
a great deal of uncertainty about what the consequences of this may be, or how serious
they may be. In our view, the greatest potential dangers are at the micro-organism level.
The uncertainty there is aggravated by the possibility of horizontal genetic transfer
(movement of genes between and within species).
In our modern agriculture, monocultures are
increasingly replacing multiple crops, a trend which genetic engineering may reinforce in
practice. That will put biological multiplicity under ever greater pressure. It is
important to emphasise the value of biological multiplicity because the total genetic
variation constitutes our gene bank.
Where the use of sprays is concerned, the
genetic modification of plants does open up opportunities for reducing it (e.g.
insect-resistant plants). At the same time, however, we may in some connections become
dependent on other sprays. We do not know the long-term effects of so-called
"harmless" sprays, and it is a cause for concern that it is often the same large
companies which produce both transgenic plants and sprays. We do not, therefore, see
reduced use of sprays in itself as a clear argument in favour of genetic engineering of
plant species.
We see no reason why genetically modified foods
should lead to less transport of the goods.
The opinion of the panel:
* Reservations concerning effects on the
environment/ecology appear to be greater among ecologists than among bio-engineers. We
find it natural to attach greater importance to the views of the ecologists.
* The panel believes that we have time to wait
in this connection, too.
Respect for complexity ought to be our
guideline.
17 In a national and a global perspective, what
will the consequences of genetically modified organisms (some of which are patented) be
for individual food producers, both economically and with regard to markets?
18 Will genetically modified foods be available
only to a few, or will that be the fate of "conventional" foods?
19 What impact will the genetic modification of
food have on global distribution policy?
20 Will an increase in production benefit those
who need it (e.g. developing countries)?
20a How will this affect population growth and
the environment in developing countries?
21 Who will define the concepts "socially
justifiable" and "sustainable development" in the Norwegian Gene Technology
Act?
The commercial production of genetically
modified food will have an impact both on economies and on markets. The technology is
still expensive to use.
High investment costs will favour the big food
producers in the primary industries. Smaller producers who lack the capital to adopt the
new technology will find it difficult to keep up with developments. On a global scale,
nearly all Norwegian producers are small. Together with the patenting of genetically
modified products there may be a risk of heavy concentration in the production of raw
materials.
As mentioned, the production of genetically
modified food is costly, so it will be concentrated among large producers and aimed at
rich markets. Niche products are likely to be the least affected by the technology and to
retain their traditional production methods.
One result of patenting GMO may be that primary
producers will to some extent lose their privilege of "taking seeds from their own
crops" without paying fees to the originating company. The panel can not see
genetically modified foods as such solving global distribution problems. Because their
economies are too weak to make use of it, genetic engineering will not be readily
available to most developing countries. For food resources to be more evenly distributed,
the first need is for political decisions to give the third world opportunities and the
necessary competence to develop.
Nevertheless, the panel does not discount the
possibility that this technology may be a tool with which to improve both the quantity and
the quality of global food production. At the same time, we must remember that most
third-world countries will be unable to benefit from genetic engineering until they have
the necessary technological and economic resources.
The panel's recommendations:
* The right of primary producers to take
"seed from their own crops" must be upheld. The situation may arise in which the
"seed" seller may demand a fee on a patented process. In such cases, support
schemes should be considered.
* The idea may be worth considering of having
producers who take out patents pay a fee to a "patent support fund". Money from
such a fund could be used to build up competence in genetic engineering in developing
countries.
22 Is there the same degree of control over
research under public and private auspices?
22a Is the control sufficient according to laws
and regulations? If not, how can it be improved?
23 If despite all control measures harm should
be done to people and the environment as a consequence of genetically modified products -
who bears the responsibility?
24 Will cheap production of genetically modified
foods be achieved at the expense of safe production?
Since genetically modified foods are new
products and may lead to unexpected legal problems, it will be important to have adequate
legislation. This applies particularly to product liability, responsibility in research
environments, and questions relating to patents.
The most important Norwegian legislation
regulating genetically modified foods is mentioned in Section II. The Norwegian Gene
Technology Act is unique in that it includes the terms "sustainable development"
and "socially justifiable" in its opening Section on the purpose of the Act.
The terms "sustainable development"
and "socially justifiable" are somewhat vague, and it would be helpful if the
politicians defined them more closely. It will also be necessary for the values underlying
those terms to find expression in future sets of rules and in their application.
We would draw attention in particular to § 23
of the Gene Technology Act, which states that "The person responsible for an activity
pursuant to the present Act has liability for damages regardless of any fault on his part
when the activity causes damage, inconvenience or loss by deliberate release or
emission...".
Two different principles are conceivable for the
control of genetically modified food: either general approval of particular methods of
production, or case-by-case approval of new genetically modified foods.
One consequence of genetic engineering is that
it may become lawful to patent genetically modified plants and animals. In our opinion,
any patents must be taken out on production processes and not on end products. That makes
it possible to require documentation and thereby improve the control and insight of the
authorities. A patent could thus also serve as a means of exercising control.
The opinion of the panel:
* It looks as if the existing statutes and rules
are sufficient for the exercise of the necessary control, but in practice this will depend
on how the expressions "socially justifiable" and "sustainable
development" are interpreted.
* In the opinion of the lay panel, the principle
of case-by-case approval of genetically modified foods should be retained, because
examples have been seen abroad (in the USA) of negative consequences of new approvals
based on earlier approvals.
* The panel believes that the guidelines for
internal control should be reviewed so as to take into account the new situation and the
new problems to which genetic engineering gives rise. This applies to internal controls
both in research and in manufacturing environments. We applaud the early start that has
been made to the preparation of new guidelines.
* The authorities set to control safety in the
development and production of genetically modified food must be granted enough funds to
enable them to carry out satisfactory controls.
* Scientists attached to public institutions
must be given working conditions which enable them both to continue their basic research
and to engage in follow-up research on genetically modified food.
25 What steps are the authorities taking to
ensure that consumers receive sufficient, reliable and easily understood information, to
enable them to take an informed attitude to the genetic modification of food?
25a What steps are the authorities taking to
ensure that genetically modified food is adequately and clearly labelled?
26 How ought genetically modified food to be
labelled?
How much information is it necessary and
reasonable to require the labelling to contain, taking into account:
- practical difficulties
- financial consequences
- the needs/wishes of particular groups (special
interest groups, allergic subjects, people with various faiths or philosophies, etc.)
27 Do we know how information and labelling
influence consumers?
Genetically modified food has not as yet been on
sale in Norway, but such products are likely to become available in our shops in the
future. Labelling is therefore a topical issue.
Section 14 of the Gene Technology Act states
that "The King may issue regulations concerning the marking of products that consist
of or contain genetically modified organisms." In addition, the Storting instructed
the Government in 1995 to see that both genetically modified raw materials and processed
foods were marked. The Ministry of the Environment is awaiting the preparation by the
health authorities of such a regulation.
Marking is certainly a large and difficult
question. In principle, anyone who, for whatever reason, does not want any form of
genetically modified food at all, should be able to avoid it. But to require all
genetically modified products, and food made from them, to be marked in every link of the
production and distribution chain would give rise to problems.
Considerable disagreement is therefore to be
expected concerning what to mark and how to mark it. There are many conflicting
considerations to take into account. The interests and attitudes of special groups, such
as allergic subjects or religious or philosophical groups, must be respected. Marking must
be informative and clear enough to leave no one uncertain.
The problems connected with marking indicate
caution: the complexity of the issue must not be used as an argument for reducing the
importance of marking (or avoiding it).
Studies carried out in several European
countries show that information does not necessarily make consumers more or less
sceptical, but does lead to more shades of opinion.
The panels' recommendations:
* In the opinion of the panel, genetically
modified products ought as far as possible to be marked. We believe consumers should be in
a position to choose the kind of food they eat. Marking proposals: bar codes, G-numbers,
both offering opportunities to obtain further information via a scanner and computer
monitor, or a small folder, brochure or the like.
* The panel urges the authorities to provide
sufficient, reliable and easily understood information on how genetically modified food is
produced and what the purpose of genetic modification is.
28 The question arises of how far we human
beings can take the manipulation of life itself, without losing some of our humanity.
Is there a danger that gene technology is moving
our ethical boundaries in a negative direction?
29 In what ways does the genetic modification of
food raise ethical problems in relation to various philosophies of life, views of nature,
and views of man's role in relation to animals?
30 What ethical requirements are
researchers/research projects required to meet?
30a What rules of research ethics have been
codified in this area?
30b Do such rules apply equally to research in
the public and the private sectors?
30c What are the functions in this area of the
National Committees for Research Ethics and the Norwegian Biotechnology Advisory Board?
30d Do any ethical rules/quality assurance
systems exist which can be applied in the course of the research/development/marketing
process?
It is the panel's view that the genetic
modification of food is ethically quite distinct from traditional breeding/plant breeding.
This is something new. We need to stop and see where we are going.
It is widely believed that in the long run man
will be obliged to take a more humble attitude to nature, in which case the unreserved
acceptance of genetically modified plants and animals would seem to exercise a regrettable
influence to the contrary.
Respect for life and nature is part of our
identity. If we uncritically adopt genetic engineering in our food production, what does
that do to us? Are we in danger of becoming insensitive and unresponsive?
Many people will have serious ethical
reservations against the use of this technology on animals. One question is how heavily
its usefulness weighs against the suffering we may cause animals? A further point may be
that it is not a question of weighing benefits against harm, but of the inexcusability of
genetically modifying animals at all.
The question is how confident we can be that
research in this area is subject to ethical guidelines, and whether the ethical aspect of
such research has been taken into consideration and in the event embodied in rules and
regulations.
Genetic engineering research is not regulated by
any specific ethical rules. In so far as the research falls within the scope of the Gene
Technology Act, the attention of the Biotechnology Advisory Board can be drawn to it.
Experiments with animals are also regulated by the Act relating to the protection of
animals and regulations governing biological experiments. The responsibility for research
projects as such lies with the National Committee for Research Ethics in Science and
Technology.
The panel's opinions:
* The panel is opposed to the inclusion of the
genetic modification of animals in food production, because we cannot see that its current
usefulness is such as to justify it.
* By researching into and adopting this
technology, we are moving boundaries, also in a historical perspective, which may lead to
changes in ourselves and in nature.
* We do not know enough about the currently
observed rules of research ethics to be able to say that they are inadequate. We
nevertheless wish to emphasise the importance in this area of good rules which are
familiar to all researchers. Why not try a cautionary code for research?
THE CONCENSUS CONFERENCE ON GENETICALLY MODIFIED
FOOD: ORGANIZATION AND PROCEDURE
Choice of conference format and theme
Increasing attention is being paid to how the
use of modern technologies can change society. Some believe that technologies can be
managed so as to serve beneficial purposes and so that harmful use can be avoided. Others
argue that some technologies have certain values "built into" their uses.
Where the introduction of complicated new
technologies is concerned, elected representatives often seek expert advice. The numbers
of experts being small, the same people tend to be consulted on a variety of issues. By
virtue of their technological expertise, a small group of people consequently exercise
great influence on social developments. Where interdisciplinary questions are concerned,
moreover, it is difficult to decide which are the most relevant specialists.
Laymen's conferences, or consensus conference as
they are known internationally, are a form of technological assessment in which groups of
ordinary citizens arrive at a considered joint opinion before a technology is adopted. The
assessment comprises different aspects of the introduction or use of a technology,
including ethical, economic, political, social and legal perspectives in addition to the
narrower technological considerations. This gives the politicians an insight into the
opinions of a selection of "ordinary people". Such conferences are thus
instruments of active democracy.
Many topics lend themselves to treatment in
laymen's conferences. Ideally, the issue should be politically topical, but should not
have been so thoroughly debated that the parties have settled their standpoints. Problem
areas which are suitable for laymen's conferences are typically ones over which opinions
are divided and which raise normative questions which concern large sections of society.
Organizers define the themes of laymen's
conferences broadly. Within wide limits - in the present case, the heading
"genetically modified food" - it is left up to the lay panel to define the
contents of the conference more closely. This is done by formulating the questions which
they want the experts to answer and which the conference is to be concerned with. It is
also the laymen who reach the conclusions and draw up the final report on the conference.
The model was developed by the Danish Board of
Technology. In the 1987 to 1996 period, the Board has held fourteen such conferences, four
of them on subjects relating to genetic engineering. In Britain, a consensus conference on
plant biotechnology was held in 1994. Three have been held in the Netherlands,
respectively concerning transgenic animals (1993), predictive genetic research (1995), and
ethical aspects of the development of nature (1996).
The layman's conference on genetically modified
food was the first to held along these lines in Norway.
Laymen's conferences are not the only form of
technological assessment. For the National Committees for Research Ethics and the
Biotechnology Advisory Board, technological assessment is part of the daily routine, as it
is for other institutions, such as the Data Inspectorate. The choice of genetically
modified food as a subject on which to test the layman model was made for the following
reasons:
* There is as yet no genetically modified food
in Norway, but there is likely to be in the immediate future.
* In Norwegian society, opinions differ on
genetic engineering and probably also on genetically modified food.
* Although genetically modified food is a
subject which affects the entire population as consumers, the discussion so far has only
been carried on among experts. But expert groups disagree, and it is not clear who
possesses the "definitive" expertise where genetically modified food is
concerned.
Aims
The aims of the conference, as defined by the
organizing committee, were:
* to give unanimous advice on genetically
modified food to politicians, the authorities, and the food industry,
* to create a forum for dialogue between experts
and non-experts, and
* to contribute to a wide-ranging and informed
public discussion of the subject.
Selection of laymen
On 30 May 1996, advertisements in ten nationwide
and regional newspapers called for laymen to participate in a conference on genetically
modified food. Some four hundred responded.
The four hundred were from all over the country.
Distribution by gender, age, occupation, education and other demographic factors was
satisfactory. Many of the letters of application revealed involvement in the subject, but
few expressed very strong views on the question of genetically modified food.
The letters varied from about half a page to two
pages in length. Some were quite comprehensive, others short and to the point. Very few of
the applicants claimed any specialised knowledge of or occupational or organizational
connections with the subject.
The panel of sixteen laymen was selected as
follows:
First, the very few who did not meet the
definition of laymen were excluded: who was considered "lay" and who
"professional" was a matter of judgement. Normal membership of an organization
with no views on or special interests in the subject was not a disqualification, but the
few applicants with prominent posts in such organizations were not defined as lay.
The project staff then sorted the remaining
letters into batches according to gender and age, from which about forty letters were
drawn, in equal numbers from each batch. The draw was partly random, but partly also took
account of places of residence, occupations, and educational qualifications. The emphasis
placed on other factors than age and gender was a matter of discretion. Great importance
was attached to arriving at a broad composition of the group on the basis of what the
letters had revealed about the writers.
The organizing committee and project staff
finally selected 16 persons, aged from 18 to 72, on the basis of the same criteria.
Preparations by the lay panel
The sixteen members of the lay panel met for two
week-ends prior to the actual laymen's conference, in August in Oslo and in September in
Ålesund. At these preparatory week-end meetings, they were made acquainted with the form
of the conference and the subject, genetically modified food. They read background
material, including a memorandum prepared by the project staff, discussed questions among
themselves, and heard two expert lecturers give broad surveys of the topic. The lecturers
were Matthias Kaiser, head of the secretariat of the National Committee for Research
Ethics in Natural Science and Technology and of the conference's organizing committee, and
Reidunn Aalen, Senior Lecturer at the Division of General Genetics at the University of
Oslo and a member of the Biotechnology Advisory Board and of the organizing committee.
Much of the time at the preparatory week-end
meetings was devoted to drawing up the questions which the conference was to be concerned
with.
Guidance in these preparations was provided by
Professor Gunnar Handal, of the University of Oslo's Department of Educational Research.
Acting as facilitator, he was neutral where the theme of the conference was concerned; his
task was to ensure that the laymen had good working conditions, functioned well as a
group, and all participated in the panel on an equal footing.
Selection of experts
During the spring and summer of 1996, the
project staff asked a large number of sources, including the contributors to the
conference, industrial enterprises, researchers and special interest organizations, to
propose matters which the lay panel ought to be aware of and experts who could address the
conference. The project staff and the organizing committee added further names, so that
the staff finished up with a list of some sixty experts in various fields from which to
choose.
Of those sixty, about forty expressed
willingness to participate. The point of departure for the selection from among them of
the panel of fifteen experts was the instructions given by the lay panel concerning the
kinds of expertise they wanted. Importance was attached to the following:
* In addition to their professional expertise,
they should be good communicators.
* Those of the experts who were engaged in
genetic engineering should as far as possible also possess food-related knowledge.
* The overall composition of the expert panel
should be such as to cover the areas relevant to the conference theme. But this criterion
had to be waived if no representative could be found for a relevant discipline or for a
group with additional knowledge concerning genetic engineering and food.
* In the most important areas, such as genetic
engineering, genetic engineering and society, and genetic engineering and ethics, more
than one expert should take part.
* A broad range of participating organizations
and institutions should be sought, as well as representation from other Nordic countries.
The fifteen experts received the questions they
were to answer in their contributions a fortnight or so ahead of the conference. They were
asked to answer 4 to 6 questions each. The majority of the questions, and especially the
normative questions, were put to more than one expert.
The conference, day by day
The first day of the conference, Friday 18
October 1996, was devoted to the experts and their 20-minute contributions in answer to
the questions each of them had been asked by the lay panel.
On the morning of Saturday 19 October, the lay
panel asked the experts to go into some of the points in their talks more closely and
asked follow-up questions. Time was also allowed for some questions and reactions from
members of the public. After lunch the conference continued behind closed doors. The lay
panel then withdrew to prepare its final report.
The lay panel continued its work on the final
report on its own throughout Sunday 20 October and on into the small hours of Monday 21
October.
On Monday 21 October 1996 the pay panel
presented its final report to the expert panel and an audience. A provisional draft of the
document was handed out. The presentation was followed by time for questions, in which the
experts were able to comment on points of fact so that any errors could be corrected in
the final document. This was followed by a general debate on the contents of the document,
with both experts and members of the public participating.
The conference was held at the Soria Moria
conference centre in Oslo on October 18, 19 and 20 October, and in the University of
Oslo's ceremonial lecture hall on 21 October.
After the conference, an editorial committee of
three members of the laymen's panel considered which of the experts' objections should be
regarded as corrections of matters of fact and which should be considered expressions of
divergent views. A few minor adjustments were then made in the provisional draft of 21
October, and the final printed report was produced.
Evaluation
The conference will be evaluated both externally
and internally. The external evaluation will be carried out by the Norwegian Institute for
Studies in Research and Higher Education (NIFU). Its report is scheduled for early 1997.
Media response and TV programs
The conference got good TV and radio coverage,
as well as featuring in national, regional and local newspapers and professional journals.
During the first three weeks after the conference, the project staff registered about
ninety news items on the conference.
In addition, NRK2 (a Norwegian Broadcasting
Corporation channel) is planning to screen four half-hour programs on the conference in
the "Akademiet" series, on consecutive Tuesdays beginning on Tuesday 7 January
1997.
Organizing committee, project staff and
contributors
The conference was planned by an organizing
committee and run by a project staff. The members of the organizing committee were:
* Matthias Kaiser, head of the secretariat of
the National Committee for Research Ethics in Science and Technology (NENT) (chairman)
* Dag Elgesem, head of the secretariat of the
National Committee for Research Ethics in the Social Sciences and Humanities (NESH)
* Jon Fixdal, research scholar at the Centre for
Technology and Culture (TMV)
* Svanhild Foldal, Senior Executive Officer, the
Biotechnology Advisory Board
* Knut Ruyter, head of the secretariat of the
National Committee for Research Ethics in Medicine (NEM)
* Reidunn Aalen, Division of General Genetics,
University of Oslo.
The project staff consisted of
* Per Sandberg, project manager
* Nina Kraft, information consultant
* Hilde Storvik, executive officer.
* Kim Paulsen, administrative assistant
The realisation of the conference was made
possible by contributions from:
* The Biotechnology Advisory Board
* The National Committees for Research Ethics
* The Ministry of Fisheries
* The Ministry of Agriculture
* The Ministry of the Environment
* The Research Council of Norway
* The Ministry of Industry and Energy
* The Centre for Technology and Culture
* The Ministry of Health and Social Affairs
* The Norwegian Food Control Authority
The total budget was in the region of NOK 1
million.
|