GENTECH archive 8.96-97

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------- start of forwarded message ------- Subject: FoEE BIOTECH
PROGRAMME MAILOUT Date: 20 Dec 96 06:50:54 EST


FRIENDS OF THE EARTH EUROPE BIOTECHNOLOGY PROGRAMME

Mailout Vol. 2 (1996), Issue 8, 15th December 1996

IN THIS ISSUE :

- - outcome of the conciliation procedure on the Novel Food Regulation
: FoEE urges Parliament to vote no - - decision imminent on Ciba
Geigys maize : more health scares revealed - - Denmark takes the
lead in labelling g.m. soya - - Revision of Directive 220 one step
nearer - - Council agrees text on revision of Directive 219 - - Norway
says "No" to genetically modified food - - Xenotransplantation : virus
transfer risk delays events in the U.K. 

			
CONCILIATION PROCEDURE ON THE NOVEL FOOD REGULATION IS COMPLETED

Since 1989, Friends of the Earth Europe has been working on the topic
of novel foods and their legal regulation at European level.  After
six years, the conciliation procedure was completed on 27th November
27 1996 - six years of political controversy and struggle, the results
of which have, of course, to be evaluated. This includes both an
evaluation of the results of the conciliation procedure and of the
actual Regulation itself.

In summary, the results of the actual conciliation procedure itself
were rather positive because the European Parliament was able to bring
through most of the amendments which it had adopted at its Plenary in
March 1996.  Several of these amendments are based on proposals made
by FoEE and other environmental and consumer organizations so, to a
certain extent, we were successful in our common effort.  However, the
resistance from all sides resulted in a Novel Food Regulation which
still lacks comprehensive labelling and an appropriate risk assessment
procedure.  The FoEE Biotechnology Programme therefore decided to ask
the Members of the European Parliament to reject the Novel Food
Regulation in its plenary session in January. 

1.  Assessment of the Results of the Conciliation Procedure

Within the conciliation procedure, the following open questions were
resolved :  - - novel foods will be labelled if they are different
from conventional foods.  The limitation, as suggested by 	the
Council of Ministers, that there must be a "significant difference"
was cancelled; - - foods also have to be labelled even if only their
agronomic traits have been changed (e.g. herbicide resistance); - -
positive labelling will be possible in the near future (i.e. a label
stating "free of genetic engineering"); - - the European Commission
declared that it will regulate the application of enzymes soon. 

In some press reports the impression was given that, as a result of
the conciliation procedure, products from genetically engineered foods
which are not different from conventional products (for example, oil
from soy beans) do not have to be labelled.  This impression is
misleading because - for the Parliament at least - this was never in
question.  Even the Environment Committee of the Parliament only
insisted on the deletion of the word "significant" when talking about
the labelling of food, which - in the opinion of the parliamentarians
- nevertheless had to be "different" before  being labelled.

The question is still open as to whether soy bean imports from the
U.S. have to labelled next year.  Questions put forward to the
Competent Authorities in Germany are "still under evaluation".  On the
other hand, the regulation applies to food which "has been hitherto
not been used to consumption to a significant degree within the
Community".  Whatever this means ......

2.  Assessment of the Novel Food Regulation in total

This assessment of the result of the negotiations concerning the Novel
Food regulation is based on four factors : a)  What were the original
proposals from environmental and consumer groups?  b)  What is the
difference between the result of the conciliation procedure and the
original proposal of the Commission?  c)  What is the difference
between the result of the conciliation procedure and the existing
legal basis for placing on the market of foods (i.e. Directive
90/220/EEC)?  d)  What possibilities/flexibility actually exist
concerning a compromise?

a)  The original proposals In 1993, FoEE initiated a common statement
on behalf of consumer and environmental organisations in which we
demanded that : - -  Scope of the regulation.  All products from GMOs
had to follow an authorization procedure.  This also had to include
food additives and enzymes.  The obligation for new authorization also
had to cover additives which were already on the market but which were
later produced by GMOs.    - - Notification/authorization procedure.
The differentiation between an authorization and a notification
procedure was not adequate to ensure comprehensive scrutiny of all
safety relevant criteria in every case.  - -  Safety assessment by
national authorities.  Because of the complexity of all relevant
questions in relation to safety assessment, a "single expert", as
proposed by the Commission, was not able to substitute a national
expert committee.  - -"4th hurdle".  When authorizing a new product,
it also had to be taken into consideration whether the food quality
was increased or whether the product was only developed to adapt
food-processing according to industrial demands.  - -  Comprehensive
labelling.  Food consisting of or made from genetically engineered
organisms or containing products therefrom had to bear a clear label
containing information on the way the food had been produced and on
its composition.  A free decision of the consumer for or against a
special food was only possible if clear and accurate labelling
existed.  - -  Competence of the deciding committees.  The members of
the different committees ("Standing Committee for Foodstuffs" and the
"Scientific Committee for Food"), responsible for deciding on approval
for placing on the market, did not necessarily have experience or
expertise in ecology, so they were not able to appropriately assess
the potential ecological risks related to the product as required by
the technical Annexes of the Deliberate Release Directive
(90/220/EEC).  - -  Transparency.  The list of members of the involved
in the Standing Committee for Foodstuffs was not available for public
which was contrary to an open, transparent and democratic control of
this committee.  Furthermore, relevant interest groups such as
environmentalists and consumer protection groups were not given the
possibility to have their own experts in all relevant committees
responsible for the authorization of novel foods. 

b)  The final result versus the original Commission proposal Due to
the continuous political pressure in Member States and on the European
Institutions, the Environment Committee of the European Parliament
agreed on almost all of the proposals described above.  The EP
Environment Committee had adopted 54 amendments to the Council's
Common Position during its second reading of the Regulation on 21st
February 1996 including provisions that : - - enzymes should be
covered by the Regulation; - - food additives already authorized need
a second authorization if they have been produced by genetically
modified organisms; - - there should only be an authorization
procedure, rather than a simple notification procedure; - - labelling
should also include food additives and enzymes; - - better
transparency should be provided during the authorization procedure to
allow both a public register and more participation of NGOs during the
authorization procedure.

Most of these amendments, however, did not obtain the necessary
majority during the second reading in the Plenary debate on 12th March
1996.

The focus of the political debate on the question of labelling also
resulted in the fact that most of the amendments accepted in the
second reading of parliament related to this topic.  Compared to the
original proposal of the Commission, the following foods have to be
labelled : - - Food or food ingredients which can be differentiated by
scientific methods from conventional food.  In this case, the
labelling must mention the characteristics of the properties modified
(composition, nutritional value) accompanied by an indication of the
method by which that characteristic or property was obtained.  - -
Food which contains materials which may give rise to ethical concerns
(this refers to specific groups of people with well-defined dietary
habits (e.g. vegetarians, kosher regimes, etc.).  - - Food which
contains materials which may have implications for the health of
certain sections of the population, e.g. allergens.  - - According to
Art. 8 (1) d, the consumer will also be informed of the presence of a
living genetically modified organism.  - - In addition, retailers and
industry have the possibility to label products "not genetically
engineered".

c)  Final result versus existing regulations The existing deliberate
release Directive 90/220/EEC which is used as the legal basis for the
placing on the market of genetically modified food has, up to now, the
following disadvantages : - - The Directive covers only living
organisms (i.e. an engineered tomato is covered whereas the placing on
the market of ketchup is not).  - - In the Commission's present
opinion, the Directive allows GMOs to be labelled only if this is
required for environmental or human health reasons.

d)  What compromises were possible During the public debate over the
past few years, NGOs were successful in "turning around" the position
of several key politicians.  For example, the responsible Minister of
Health in Germany, Mr. Seehofer, argued against labelling at the
beginning of the debate.  In the first reading by the EP in October
1993, many conservative members of the European Parliament also voted
against positive proposals made by the responsible rapporteur,
Mrs. Dagmar Roth-Behrendt (PES, Germany) and by other parliamentarians
such as Hiltrud Breyer from the Greens, whereas they at least
partially agreed on them subsequently.

All these things changed over the years.  However, the blocking
policy, especially of the Commission and the Member States France and
the United Kingdom, made a compromise extremely difficult. 

3.  Final assessment

As already mentioned, the Friends of the Earth Biotechnology Programme
decided to ask the European Parliament to reject the Novel Food
Regulation in its plenary session in January 1997.  Although the final
agreement is certainly an improvement over the Common Position of the
Council (not to mention the original proposal from the Commission)
because of parliamentary interventions, it still has many weak points,
loopholes and exemptions.  If the European Parliament were to vote in
favour at its Plenary Session in January 1997 and the Novel Food
Regulation were to come into force as proposed, this would effectively
result in the following :

- - a wide variety of products will not be labelled - for example :
oil and other derivatives (such as lethicin) of genetically modified
soya*, products manufactured with starch from genetically modified
maize, sugar from transgenic sugar beet, because they are not
"different" from a molecular point of view.  Enzymes or food additives
produced with the help of genetically modified organisms (GMOs), etc.,
will not be labelled.  (*for clarification: if the oil differs in
fatty acid content and this difference can be demonstrated through
analysis, it has to be labelled)

- - there are no guarantees that the wording "genetically engineered"
will actually appear on the labels used to indicate that the food is,
in fact, genetically engineered.  The only exception is the labelling
of living organisms according to Article 8 (1) d.

- - enzymes, which are becoming increasingly widespread in
food-processing, are not covered by the scope of the Novel Food
Regulation.

- - food additives which are already on the market will not need
either a second safety evaluation or a new authorization to be placed
on the market, although they are produced with the help of a GMO.

- - from the start of the Regulation coming into effect, there will
already be a simplified notification procedure as well as the
authorization procedure.

- - the Commission has the still the right to decide against the
majority vote of the Member States although the Commission does not
have with technical facilities to control the data provided by the
notifier.

- - the deciding Standing Committee for Foodstuffs, as referred to in
Article 13 of the Regulation, does not have the required ecological
competence to properly evaluate the potential ecological risks related
to the large-scale deliberate release of GMOs as a result of placing a
novel food on the market.

- - the work of the deciding Scientific Committee for Foodstuffs is
not transparent, and consumer and environmental organisations are not
participating in the decision-making process.

According to Art 15, the Novel Food Regulation will come into force
three months after publication in the Official Journal.  In case the
Council and the Parliament agree on the compromise, this will probably
be on 1st May 1997.

(JK)


IMMINENT DECISION ON CIBA GEIGY'S GENETICALLY MODIFIED MAIZE AMID NEW
SAFETY CONCERNS

Approval for the Ciba Geigy maize has been stalled since June this
year when only 1 (France) out of 15 EU Environment Ministers voted in
favour of its authorization.  The topic was back on the agenda again
for the Environment Ministers during the Council meeting on Monday,
9th December, although it was relegated to a discussion over lunch
rather than being a formal agenda item.  Environment Ministers, under
pressure in their own countries, urged the Commission to stick to the
18th December deadline for its decision on whether to allow the maize
to be released in the EU.  During the discussion, Commissioner
Bjerregaard apparently raised the possibility of changing the rules
for future approvals of genetically modified organisms to include a
labelling requirement which was described by a Commission official as
clearly a political commitment on her part to make sure that, in
future cases, you have labelling requirements.  This is interesting
in relation to the articles in this Mailout on the Novel Food
Regulation and the proposed revision of Directive 220.

Genetech maize already entering the EU ?

On 27th November, Member States were officially warned in a letter
from the Director General of DG XI of the Commission to the national
Competent Authorities that genetically modified maize could already be
entering the European Union.  Countries thought to be the most likely
to have received deliveries of the genetech maize from the U.S. are
Spain, Portugal, the Netherlands and Belgium.  The Commission stressed
that the maize is prohibited in the EU until such time as
authorization is granted and that it is therefore the responsibility
of each Member State to ensure that the product does not enter its
market; otherwise, they are in breach of Community law.  According to
a report from Reuters, a Commission spokesman, who declined to be
named, said : There may be non-authorized maize in Europe.  We know
that maize is arriving in EU ports and we are not at all excluding
that there may be gene-modified maize in some.  On the other hand, a
U.S. spokeswoman in Brussels was quoted as saying We are not aware
of a single shipment from the United States.  Although Europe would be
within its rights to block genetically modified corn, it would have to
prove that it was in the cargo.

 New concerns voiced in the U.K.

As readers of this Mailout will know, the Ciba Geigy maize has been
genetically engineered to be both herbicide- and insect-resistant and
also carries a marker gene which is resistant to the antibiotic
Ampicillin.  It is this latter property which has been raising renewed
concerns over the past few weeks, particularly in the United Kingdom.
The danger of transfer of antibiotic-resistance has been highlighted
by the British media - including The Independent, The Financial
Times, and the BBC - which reported on new fears that consumption of
the maize could lead to transfer of antibiotic resistance first to
animals and subsequently to humans.  Government scientific advisers
were reported to have confirmed "a slight possibility of transfer of
antibiotic resistance".  Although such transfer was not widely
believed to be possible after processing of the maize, during which
the living genetic material would, in principle, be destroyed, a front
page article in The Independent on 4th December reported that the
Ministry of Agriculture, Fisheries and Food (MAFF) had asked a
government laboratory to see if any of the DNA in the modified product
would remain after processing.  The resultant briefing states :  It
appears that fragments can survive and MAFF are now seeking the views
of independent experts ..... about whether this changes their view on
the risk of processed maize.

Apparently, more research is now underway.  If such research does
indeed demonstrate that some living genetic material CAN survive
processing, such as cooking and boiling, it will not only confirm
consumers and environmentalists worst fears but also regenerate
more debate around the Novel Food Regulation under which processed
foods deriving from GMOs would not normally be labelled. 

The nervous atmosphere in the U.K. was further compounded by the worst
ever case of (E-coli) food poisoning in the country, which has already
resulted in about a dozen deaths, and an article in the medical
journal The Lancet in early December which reported that a certain
type of intestinal bacteria had been found to THRIVE on a particular
antibiotic.  Speaking on the radio, the harassed Environment Minister,
John Gummer, said "The Americans are trying to pass it (the maize) on
to Europe without us making up our own minds.  My view is that one of
the important reasons for the European Union is that we are strong
enough to decided what we want in our food chain".  He reiterated that
he would stick to his guns and keep genetically modified maize out of
the U.K. until the Commission reached its decision on 18th December,
based on the opinions delivered by the three Scientific Committees on
Food, Animal Nutrition and Pesticides.  On the same day, the head of
Ciba Seeds in the U.K., questioned during an interview with the BBC
said that even if the resistance is passed on, it would soon
disappear.  This is indeed an extraordinary statement since the
first part of the sentence appears to imply that he recognizes the
risk, while the second part of the sentence requires some scientific
back-up - such as: on what basis? how soon? etc.

FoEE issues Press Release

On 5th December, just before the meeting of the Environment Council,
FoEE issued a Press Release in which we reiterated our concerns that :
- - herbicide-resistant crops will lead to increased use of
herbicides,  - -  that the use of a bacterial gene (Bt : bacillus
thuringensis) as a toxin against insects will have detrimental effects
on beneficial insects and on biodiversity in general, as well as
jeopardizing the position of organic farmers who sparingly use
naturally-occurring Bt in an environmentally-friendly way to prevent
insect infestation.  - - there is a real danger of
antibiotic-resistance being passed on through the food chain, both to
animals and humans.

The Press Release reminded readers that the import of genetically
modified soya from the U.S. this autumn has already caused an outcry
from consumer and environmental groups, together with a demand that
all processed foods made from soya should be labelled, and stressed
that adequate labelling is unfortunately NOT what the European public
will get from the Novel Food Regulation since, in most cases, only the
raw material of genetically modified crops - such as maize and soya -
will be labelled while their derivatives in the form of processed food
will not (see separate article on page 1 of this Mailout).

In summary, the FoEE Biotech Programme : - - demanded that the
European Commission and the Council of Ministers reject the Ciba Geigy
application; - - demanded that the EU puts environmental and consumer
considerations above financial and business interests; - - urged the
EU Environment Ministers not to let themselves be pressurized by the
United States to accept genetically modified food in any form, either
for animal or human consumption; - - called on the European Parliament
to reject the Novel Food Regulation because it only provides for very
limited labelling; - - reiterated the fact that gene food is not only
a question of scientific evaluation but also of consumer choice.

"European consumers have the basic democratic right to be informed
about what is going into food production. Some authorities think that
most consumers are too stupid to understand labelling and therefore
it's not useful.  We believe that proper consumer information is a
fundamental principle and that people should not be fobbed off with
assurances that gene food can do no harm in the long term.  The public
received similar assurances for years about BSE" concluded the Press
Release, which was also sent to all the EU Environment Ministers.

Commission decision before year-end

It is expected that the decision whether or not to authorize Ciba
Geigys maize will be announced on Wednesday, 18th December,
following the meeting of the College of Commissioners at which the
findings of the three Scientific Committees on Food, Animal Nutrition
and Pesticides will be presented.

Although Member States are split, with France being the only Member
States which actually wants to grow the maize and with the Netherlands
putting forward a compromise proposal that authorization should only
be given for animal consumption, it is widely expected that the
Commission WILL authorize the maize, albeit perhaps with some
limitations.  If the decision is announced before copying and posting
this Mailout is completed, a short flier will be included in the
Mailout at the last minute giving the basic results of the decision.

(GL)


SOYA : DENMARK SETS THE EU AN EXAMPLE IN LABELLING AND CONSUMERS'
RIGHTS!

Information received from our colleague Jesper Toft of NOAH/FoE
Denmark indicates that the Danish National Food Agency has decided
that all food products containing modified soya MUST BE LABELLED (with
the exception of the additive Lethicin (E322)).  The wording will
either be produced by genetically modified soya or contains
genetically modified soya.  Where the labelling is in the form of a
sticker, it is not enough just to write genetically modified;
rather, it has to be stated which item has been genetically modified.
The wording must also not be written in a way which could confuse or
mislead the consumer - for instance, produced with the help of gene
technology is not as satisfactory as improved with gene
technology.  It will also be possible to use so-called negative
labelling, i.e. not produced from genetically modified soya if it
can be proved that this is the case.  Since imports of mixed -
genetically modified and traditional - soya are already entering the
EU market, labels which state could be produced from genetically
modified soya would be acceptable as a solution to that problem.  

The question arises, of course, as to whether the Danish National Food
Agencys decision is not in breach with the Novel Food Regulation
discussed in the first article of this Mailout.  The Danish NFAs
interpretation, however, is that the Novel Food Regulation is not yet
law in the EU and that genetically modified soya is already on the
market and therefore will not be novel when the NFR is expected to
come into effect in May or June next year.  

Apparently, the United States is now threatening Denmark under World
Trade Organization rules which the U.S. claims do not allow for such
labelling. 

(GL)


REVISION OF DIRECTIVE 200 MOVES A STEP CLOSER

(See Mailouts Vol. 2 Issue 6, Issue 2)

On Tuesday, 10th December, the European Commission adopted its report
on the proposed revision of Directive 90/220/EEC which regulates the
deliberate release of genetically modified organisms.  The Commission
says that the existing Directive is not clear enough about the
objectives for GMO risk assessment which could lead to cumbersome
procedures for low risk releases, and that there is poor correlation
between Section B of the Directive on experimental releases and
Section C on the release of products on to the market.  Also according
to the Commissions report, cumbersome administrative procedures lead
to delays in approval of GMO products and that these are further
compounded by the lack of an active Commission role in Section C which
means that the executive cannot suggest simplified procedures.  The
report also says that the absence of an independent body of scientists
to resolve disputes and the lack of sufficient flexibility for
technical adaptation creates problems for marketing approvals.
Furthermore, the Directive makes no provisions for labelling
requirements although, according to the report it will be essential
to address this issue in order to take account of the need to inform
consumers and to comply with international obligations.

The Commission is proposing amendments to Directive 90/220/EEC under
the Co-Decision Procedure (between Parliament and the Council).
  
The FoEE Biotech Programme will return to this topic with analysis of
the Commissions proposals in the next Mailout.

(GL)


COUNCIL AGREES COMPROMISE TEXT ON REVISION OF DIRECTIVE 219

(See Mailouts Vol. 2 Issue 5, Issue 1)

The following text is taken from the Conclusions of the EU Environment
Council held in Brussels on 9th December :

Meeting in Brussels on Monday, 9th December, the Environment Council
reached a common understanding on the basis of a compromise text on
the proposal for amending Directive 90/219/EEC on the contained use of
genetically modified micro-organisms (GMMs).  A common position will
be adopted once the Parliaments opinion is available.  Directive 219
lays down common measures for the contained use of GMMs with the aim
of protecting human health and the environment.  Taking into account
the experience and scientific knowledge gained over the last few
years, the proposal to revise the Directive foresees : - - updating
the scope of the directive; - - providing simplified procedures for
further technical amendments; - - modifying the risk categorization of
the contained-use activities; - - adapting the administrative
procedures and modification requirements to the actual risk level of
activities; - - further specifying the containment and control
measures to be applied.

With this in mind, the main elements of the compromise text are : - -
Article 2, together with the information on waste management (Annex V
part A) and the protective measures for waste (Annex IV), clarifies
the distinction between the scope of the present Directive and of
Directive 90/220/EEC and aims at avoiding an interpretation of the
provisions of the Directives whereby the dumping of GMMs as waste
without any control or risk assessment could be allowed.  - - Article
5, read in conjunction with Annex III, makes it clear that containment
measures have to be selected following a risk assessment of the GMM
and activity, and foresees a 4-class system of contained use to
reflect the need to properly differentiate according to risk level.  -
- Articles 7 to 10 establish a notification system in line with the
principle of graduated requirements, increasing in relation to the
level of risk, whilst keeping a balance between administrative
requirements and safety.  - - Article 3 foresees limited exemptions
for GMMs for which the safety to human health and the environment has
been established.  - - Annex III provides specific guidance on the
inclusion of GMMs in Class 1 and details the successive steps of the
procedure which will lead to the assignment of the contained use to
one of the 4 classes established under Article 5.  - - Annex IV
presents the applicable containment and other protective measures to
the various containment levels, ensures that - even for Class 1
contained uses - basic safety principles are applied, and properly
graduates the requirements in relation to the overall level of
containment.

The FoEE Biotech Programme will return to this topic in the next
Mailout.

(source : EU Press Release)


NORWEGIANS SAYS "NO" TO GENETICALLY MODIFIED FOOD
  
There is no need for genetically modified food in Norway today as the
selection and quality of ordinary food is satisfactory.  This was the
main conclusion from lay people participating in Norway's first lay
people's conference which took place 18-21 October 1996 in Oslo.  The
conference was organized by the National Committees for Research
Ethics and the Norwegian Biotechnology Advisory Board.

The conference model The lay people's panel consisted of eight women
and eight men from different parts of Norway.  The participants were
selected from approximately 400 respondents to advertisements in local
and national newspapers, and varied greatly in age, education and
occupation.  They had one thing in common: no particular prior
knowledge of the subject to be discussed and no close connections to
gene technology research, businesses or organizations with strong
opinions on the matter.  They had, however, been introduced to the
complexities of the theme during two weekend meetings previous to the
conference.

At the conference, the lay people met with a panel of 15 experts;
including experts on genetic engineering, on food and health, on
environmental risks, and on the wide-ranging social and ethical
implications.  The role of the experts was to answer questions
prepared in advance by the lay people.

The conference model followed that used by The Danish Board of
Technology.  Over a period of more than ten years, Denmark has
arranged 13 such conferences on different subject matters.  The same
conference model has, with some modifications, been applied once in
Britain and twice in The Netherlands.

The recommendations The concluding document contained several detailed
recommendations to Norwegian politicians and the food industry.
Although the panel did not support the introduction of genetically
modified foods to Norway, they did anticipate that this might happen
anyway.  If it does, they demanded that all foods containing
genetically modified organisms or where genetic engineering has been
used in the manufacturing process should be labelled.

The lay people emphasized that the public might be sceptical to the
use of gene technology in foodstuffs for several reasons.  According
to the panel, a negative stand on the use of gene technology in
connection with food production based on ecology concerns or on
ethical grounds must be respected on the same level as arguments
related to the contents of the products.

The panel did not foresee any major health or environment problems but
were concerned with unforeseen and unintended risks due to the
introduction of this new technology.  They argued that the
precautionary principle must apply, and suggested a "be aware" poster
for researchers.

The lay people's panel called for more research both on long term
health effects of consuming genetically engineered foodstuffs and on
environmental effects.  They remarked that ecologists and
biotechnologists often have opposing views on environmental effects of
GMOs.  The opinion of the ecologists must carry the larger weight, the
panel argued.  Furthermore, they called for more research on how to
ameliorate the nutrition value of plants and less on genetic
engineering for commercial reasons, such as introducing genes to make
plants resistant to herbicides.  They demanded that antibiotic
resistant genes should not be used as markers.

The Norwegian Gene Technology Act from 1993 emphasizes that the
technology should represent a benefit to the community and a
contribution to sustainable development.  The lay people's panel
applauded these values, but argued that they ought to be more
precisely defined.  These clauses could, however, be used to prevent
the import of genetically modified products from other European
countries, according to the panel.  (Norway is not a member of the
European Union but is closely connected through the Agreement on the
European Economic Area).

The lay people were, in principle, sympathetic to the idea that
genetically engineered foods may lead to increased production of food
for poor people in developing countries but pointed out that this is
not how the technology is used at the present time.  They suggested
establishing a "patenting fund" to make this technology more
accessible to Third World countries.  They also supported the farmers'
privilege principle.

Favourable reactions The 15 experts were impressed both with the
quality of the lay people's report and with their grasp of the complex
issues.  "This is a historic occasion and perhaps a small victory for
democracy" said Professor Reider Almas as the document was presented
to the experts.  Almas, who is head of the Centre for Rural Research,
added that the conference has proven that ordinary modern citizens are
capable of understanding complicated processes and producing valuable
advice.  The conference has also attracted positive interest from
members of the Norwegian Parliament.

An English translation of the panel report will be available shortly
from Nina Kraft, The National Committees for Research Ethics,
T. 47-22-958797, F. 47-22-698471, E-mail <hstorvik@online.no>.

(source :  Press Release, National Committees for Research Ethics -
NEM, NENT & NESH, Norway)


HEALTH SCARES DELAY PROGRESS IN XENOTRANSPLANTATION

It is reported that the publication of a U.K. government report on the
use of genetically modified animal organs for human transplants has
been delayed.  The report was due to be issued during the week
commencing 16th December but this has apparently now been put off
following renewed concerns about animal viruses crossing the species
barrier to humans with potentially fatal results.

It had originally been anticipated that field tests with heart
transplants from pigs to humans would begin in the U.K. in about one
years time.  The technicque has been developed by scientists in
Cambridge and the pigs in question have been specially bred with human
genes to minimize the short-term risk of rejection of the animal
organs, although the risk of longer-term rejection remains unclear.

In a radio interview, a professor from the Nuffield Council for
Bioethics said that work in xenotransplantation should proceed with
caution and that there is a significant risk of virus transfer.
There is currently no regulatory framework covering
xenotransplantation and the danger of virus transfer affects not only
the recipient of the organ but also all those who are in contact with
the patient, such as partners, family and healthcare workers.  Such
risks have long been highlighted by many interest groups who also
oppose xenotransplantation on ethical and animal welfare grounds.

Later on the same day, however, it was reported by the BBC that the
U.K. government had decided to accept scientists' recommendations that
pigs' hearts should be used for human transplants and that a report on
the safety and ethics of such work has been accepted.  This, the
report said, despite concerns about "deadly" animal viruses and the
fact that certain pig viruses can grow in human tissue as a result of
by-passing the body's natural defence mechanisms after transplant.

It was also revealed that the first pig-to-human transplant had taken
place in Amman, India, where a pig's heart has been transplanted
alongside the existing, malfunctioning heart of a 30 year old man  

(GL)


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POST SCRIPTUM

EUROPEAN COMMISSION GIVES THE GREEN LIGHT TO GENETECH MAIZE

As expected, on 18th December the European Commission announced its
decision to authorize the market release of Ciba Geigy's genetically
modified maize.  We are including in the mail copy of this Mailout the
full text of the Commission's press release on this subject.  -------
end -------