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May 4, 2000


Novartis rebuttal of Greenpeace study from Ecostrat


AgBioView - http://www.agbioworld.org, http://agbioview.listbot.com

From: Klaus Ammann

Dear Friends,

Here is the rebuttal of the Greenpeace - Ecostrat study from Novartis
For me it is most striking to see that the study does not take into account
the latest research done last summer.

Clearly some of the ecological lab and field studies certainly go way beyond
the original materials submitted to EPA, but it is exactly the new field
studies which support the approvals. If you reverse this sentence you can
feel tempted to critizise the EPA foundations for the approvals, but this
would be very superficial and clearly would show a biased agenda:

Actually there are many new field studies showing
that EPA and all the affiliated scientists in all the below cited committees
have done an excellent job. Maybe on should honestly add that in some way
the authors of the first studies where just lucky...

Basically I am amazed that ecologists such as the authors of the Greenpeace
study have such a strict reductionistic attitude. Lab studies can help for
first assessments, which then have to be verified in field studies, this
very obvious rule seems to be forgotten in the fight on the pros and cons of
GT crops.

One of the so often cited reductionistic studies has been written by Losey,
who was well aware of these flaws reductionistic studies can contain, and he
explicitely stated this in his famous Nature study on the Monarch larvae, but
it is a sad fact that many opponents just on purpose overlook these
important two lines in the article.

How about a comparative study on the bitter components of old oilseedrape
traits, which have now been replaced by the 00 traits ?

I bet that many of the natural pesticides built in the plants also do
considerable harm to 'non-target' insects, - this is how they have
developed through selection over the ages through some selective advantage
-- are there any reductionistic - or even better: field experiments
available ?

Overall: The Greenpeace study lacks twofold a scientific baseline:
1) the baseline of comparative lab and field studies
2) the baseline to conventional crops as a whole

It is a study where the negative agenda is clearly on the surface,
to call it still a 'hidden' agenda is certainly an understatement
if not a laugh.

Having written this I must remind the readers of one aspect which still
needs careful observation: The reductionistic studies have shown some toxic
effects, and I think it is only fair to admit that long term observation is
an absolute necessity, since the intricate web of an ecological system has
so many feedbacks and so many long term effects will pop up later and maybe
at quite unexpected places and niches. But until then you have to balance
those long term risks against the benefits this new technology certainly is
showing. After all, those Bt crops are out in the fields in mass releases
for +- 6 years already and any dramatic effects would have been
detected with certainty.

thanks, Sheena Bethell-Cox for sending this statement

Dear colleagues,

You may have seen a press release from Greepeace, claiming that the risk
assessment of Novartis Bt maize is flawed and has calling for an immediate ban
of the crop. Greenpeace refers to a report by EcoStrat, which claims that the
studies to assess the safety of Bt maize on were poorly designed. The report
was authored by Angelika Hilbeck, among others.

The Greenpeace news release can be found at:
I have attached the EcoStrat report here as a .pdf file or you can find it on
the Greenpeace US web site:
(See attached file: gmo-report-ecostrat.pdf)

Novartis has developed a position statement on this subject, which I have
attached here. Please feel free to distribute this to your network.
Willy de Greef, Novartis, Head of Regulatory and Governmental Affairs,

Risk Assessment of Bt maize is thorough and conclusive

Position Statement

In the most recent in a long series of unfounded attacks on biotechnology,
Greenpeace has made some serious allegations about the risk assessment
undertaken on Novartis Bt maize and has called for it to be taken off the
market. They have referred to a report by EcoStrat, which reviews the
studies to assess the safety of Bt crops. There is nothing presented by the
EcoStrat report that has not already been thoroughly evaluated by regulatory
and scientific committees.
Novartis rejects the Greenpeace claim that the risk assessment for Bt maize
is inadequate. Greenpeace has again made serious allegations about
genetically enhanced products that are not based in fact. The EcoStrat
report is an incomplete compilation of studies done to assess the effect of
Bt crops on non-target organisms and is inconsistent in its critique of the
study protocols used. There is no basis in the report for the broad and
damning conclusions that Greenpeace have presented.
Contrary to the Greenpeace allegation, this is not the first time that
independent scientists have assessed the studies presented to the competent
authorities. Independent scientists, both in the EU, North America and
elsewhere, have evaluated Bt maize and have concluded that it is as safe as
conventional maize. In the EU, for example, the regulatory dossier for
Novartis Bt maize was submitted to 15 national scientific committees and 3
EU scientific committees. These committees gather the best available EU
experts to assess genetically modified products, including any new evidence
that may arise. To say, as Greenpeace has, that these highly skilled
scientific committees "could be deceived" is ridiculous.
The environmental impact of Bt maize, including the impact on non-target
insects, is part of this safety assessment and of ongoing work. The
overwhelming body of scientific evidence supports the view that non-target
insect populations are not at risk from Bt maize.
The US Environmental Protection Agency (EPA) has recently released a Fact
Sheet on Novartis Bt maize. In it, it outlines the evaluation done on Bt
maize, including studies done on ecological effects and effects on
non-target beneficial organisms. It includes a formal review of studies
done by Angelika Hilbeck, one of the authors of the EcoStrat report, on the
effects of Bt maize on the green lacewing, a beneficial insect. The EPA
concludes, "the results of these studies do not support the conclusion that
the Bt toxin was directly responsible for the observed differences in
lacewing mortalities." Furthermore, they conclude "compared to crops
treated with conventional chemical pesticides, the transgenic crops have no
detrimental effect on a substantial number of individuals in beneficial
insect populations."
Similarly, the EU Scientific Committee on Plants has concluded that
additional information on the effects of Bt maize on non-target organisms
does not invalidate its original risk assessment for Bt maize.
Novartis stands by the safety and quality of its products and continues to
have the fullest confidence in the quality of the scientific evaluation done
by regulatory authorities and scientific advisory bodies.

Klaus Ammann
Botanical Garden, University of Bern
Altenbergrain 21
CH - 3013 Bern, Switzerland
Tel. +41 31 631 49 37
Fax +41 31 631 49 93