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ISIS Report 24/05/04
Approval of Bt11 Maize Endangers Humans and
Livestock
Dr. Mae-Wan Ho explains why
the European Commission’s decision to approve Syngenta’s GM maize is
illegal and criminal based on existing scientific evidence.
The European Commission ended 6 years of de facto moratorium on
GM authorization by approving Syngenta’s Bt11 sweet corn for food use in
Europe on 19 May 2004 (see Box 1). That, despite the fact that voting by
experts last December in the EU’s Standing Committee on Food Chain and
Animal Health was an even 6-6 country split with three abstentions. Finland,
Sweden, Ireland, UK, Netherlands, and Spain voted in favour; Greece, Denmark,
France, Austria, Luxembourg, Portugal voted against; and Belgium, Italy and
Germany abstained. The same split happened at the Council of Ministers on 27
April, but this time Italy voted in favour, while Spain abstained.
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Box 1
History of Bt11 maize approval
An official dossier was
submitted to the European Union in 1996 and approved under the old Directive
for deliberate release into the environment (90/220/EEC) for import and
processing since 22 April 1998.
Two notifications for cultivation were submitted in 1996 (to
France) and 1998 (to Spain). The Scientific Committee on Plants (SCP) gave a
favourable opinion for these two notifications, although Syngenta has since
withdrawn the latter. The 1996 notification was updated in 1998 and 2002, and
finally in 2003, additional information was supplied as required by the new
Directive for deliberate release 2001/18/EC. The French competent authority
concluded that, in this respect, Bt11 "does not present a greater risk to human
health or the environment than any other variety of maize". Approval is still
pending.
In February 1999, a request was submitted under Regulation (EC)
258/97 for placing sweetcorn from GM maize line Bt11 on the market for food use
(fresh or processed). On 17 April 2002, the Scientific Committee on Food gave
its opinion that Bt11 sweetcorn is as safe for human food use as its
conventional counterparts.
The vote in the Standing Committee on Food Chain and Animal
Health, December 2003, resulted in an even 6-6 country split with three
abstentions. A similar split ratio in the Council of Ministers 27 April 2004
led to a stalemate. The European Commission broke the deadlock by deciding in
favour of approval. |
Belgium’s scientists first expressed concerns over the safety of
Bt11 when they subjected Bt11 to molecular characterisation, as required by
Europe’s current Directive for deliberate release. These concerns were
strongly reinforced by French and Austrian scientists.
According to an article in Le Monde published 24 April, two
scientific evaluation committees, in France and Belgium, have refused to give
their approval for food use of Bt11 sweetcorn. On 22 April, AFSSA (French
Agency of Food Sanitary Security) opposed the authorization of Bt11 sweetcorn
for the third time, after having refused it twice before, in 2000 and 2003, on
grounds that the scientific results were insufficient.
In a brief note published 22 April, implicitly replying to the European
Commission statement on 5 February that "the results supplied by
Syngenta…are in accordance with the criteria and rules defined in the
recommendation 618/97/EC", AFSSA said it "maintains its previous opinion which
concluded that to rigorously evaluate the impact of regular consumption of a
maize carrying the Bt11 event, toxicity/tolerance experiments on rats must be
carried out… Such toxicity/tolerance experiments are not required by the
actual regulation, though they might be advisable … because the sweetcorn
is the only one to be consumed by humans."
The Belgian Council for Biosafety had already refused to give its
approval for the Bt11 maize on 1 April 2004.
Dr. Mae-Wan Ho and Prof. Joe Cummins from ISIS and the ISP (Independent
Science Panel) have objected strongly to the approval of a range of GM crops;
and called for the withdrawal of approval already granted, most probably for
the same reasons as the Belgian and French scientists: the GM inserts in all
these crops were found to have rearranged since characterised by the company.
That is a sign that the GM varieties are unstable, and hence contrary to
requirement laid down by the current European Directive for deliberate release
(2001/18/EC). Furthermore, there is evidence that some GM varieties are
non-uniform, also contrary to the requirement of the current European
Directive. Thus, the European Commission is contravening its own laws in
approving Bt11.
Ho and Cummins have referred to this as both "illegal and criminal";
criminal because transgenic instability is a key safety issue, and there is
already evidence suggesting that GM food and feed are far from safe, even
though very few feeding trials have been carried out, and toxicological tests
on natural Bt toxins are thoroughly inadequate to predict the much altered GM
toxins incorporated into GM crops (see "GM food and feed not fit for "man or
beast"). In short, approval of Bt11 sweetcorn is endangering livestock and
human beings.
Belgian scientists characterised the GM insert in Bt11 and reported,
that "rearrangements, truncations and unexpected insertions" have taken place
(see Box 2), that further inserts may be present, that the insert has landed in
what turns out to be suspected "megatransposons" involved in exchanging
segments between chromosomes, and that further it is contaminated with Bt176, a
GM variety that has just been withdrawn from cultivation in Spain.
This is a damning indictment of the European Commission’s
decision.
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Box 2
Molecular characterisations by Belgian Council for
Biosafety
The plasmid used for making Bt11 contains a synthetic truncated
crylAb sequence isolated from soil bacterium Bacillus thuringiensis
kurstaki HDI, and a synthetic pat gene, isolated from
Streptomyces viridochromogenes, another soil bacterium. Both coding
sequences are driven by a 35S promoter sequence derived from cauliflower mosaic
virus (CaMV) 35S promoter and the 3’ untranslated region of the nopaline
synthase (nos) gene from a third soil bacterium Agrobacterium
tumefaciens. In addition, the promoter sequences of the pat and cry1Ab gene
were combined with respectively intron Int II and Int VI derived
from maize alcohol dehydrogenase adh1S gene to enhance expression.
The company’s dossier claimed a single copy insert with the
structure:
p35S-Int
II-pat-tnos-p35S-Int
VI-crylAb-tnos
But analyses by the Belgian Council for Biosafety revealed
"primary insert with rearrangements, truncations and unexpected insertions",
and "it is not certain if only one copy of the insert is present". Furthermore,
1.1kbp of the plasmid sequence was present at the 5’ end of the insert,
followed by plant DNA with homology to 180bp knob specific repeat sequence. At
the 3’ end, the plasmid sequence is again present followed by plant DNA
with homology to the 180dp knob specific repeat sequence.
Although not discussed by the study, knob specific sequences
are present in many maize chromosomes, and are suspected to be
"megatransposons" involved in exchanges of whole chromosome segments in the
genome. If so, the insert has landed in a megatransposon, and has the potential
to spread uncontrollably over the entire genome. |
Another worrying finding is that PCR primers for Bt176 amplify sequences
from both Bt176 and Bt11, suggesting that Bt11 may have been contaminated by
Bt176. Bt176 has been linked to the death of 12 dairy cows in Hesse Germany
between 2001 and 2002; and approval for growing Bt 176 has just been withdrawn
in Spain on grounds that it has an antibiotic resistance marker gene that the
European Food Safety Authority recommends should not be present in GM crops
placed on the market.
The Belgian Council for Biosafety concluded: "There are still
uncertainties concerning the molecular data provided in the dossier
C/F/96/05-10; rearrangements in the insert and truncations of parts of the
insert might have occurred. Therefore, the sequence of the insert should be
further checked together with the number of inserts."
Sources
Ho MW and Cummins J. GM
food and feed not fit for "man or beast". ISIS Report, 7 May 2004
"European Union lifts GM food ban" BBC News World Edition 19 May
2004.
Report of the molecular characterisation of the genetic map of event
Bt11
(June 2003)
http://www.biosafety.be/TP/MGC_reports/Report_Bt11.pdf
Ananiev EV, Phillips RL and Rines HW. A knob-associated tandem repeat in
maize capable of forming fold-back DNA segments: are chromosome knobs
megatransposons? Proc Natl Acad Sci USA 1998, 95, 10785-90.
"AFSSA Does not Approve a GMO Which Brussels Wants to Authorise"
Herve Kempf. Le Monde (France). 24 April 2004.
www.saveourseeds.org
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