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Controversial GM maize approved by European Commission
In 2003, Monsanto submitted a request to market the GM maize MON 863 with
resistance to corn rootworm to the regulatory authority in Germany. Monsanto
was seeking approval for importing the maize into the Europe for processing
and use as feed, but not as food or for cultivation.
The German authority concluded that there was no scientific
evidence of risk for human health or the environment. But other Member States
raised and maintained objections over molecular characterisation, the potential
for allergic reactions, toxicity and other aspects. Most controversially,
the feeding study submitted by Monsanto turned up many adverse effects 
that were dismissed by Monsanto as “not biologically meaningful.”
Monsanto, supported by European
Food Safety Authority (EFSA), kept the study from public scrutiny under a
false claim of confidential business information until a German court order
a year later forced Monsanto to release the full report.
Preliminary analysis by
Giles-Eric Séralini and colleagues of Criigen (Committee for Independent Research
and Information on Genetic Engineering, France)  found serious flaws in
the study at every stage, from experimental design, to data collection, analysis,
and reporting. The GM maize fed group was compared, not just to the group
fed the non-GM isogenic line as it should have been, but also to five more
‘control’ groups fed other non-GM varieties. This had the effect of increasing
the range of variation and making the treatment group of animals too small,
thus considerably reducing the sensitivity of the test. The results were analysed
with the wrong statistical tests, and despite having compared many variables,
the correct standard statistical tools (multivariate and principal component
analyses) were not used. Instead, in comparing one variable at a time, the
researchers failed to note significant trends in body weight differences between
experimental and control animals. Statistically significant differences that
nevertheless turned up were then all dismissed as biologically insignificant.
The EFSA, when consulted,
agreed with Monsanto, and gave MON 863 maize a ‘positive opinion’. In August
2005, the European Commission gave approval to maize MON 863 , despite
a persistent failure to reach an agreement by all regulatory authorities.
Monsanto’s study revisited
Monsanto published a report on the study in 2006 , restating its position
that the significant differences between transgenic and non-transgenic fed
groups were “not biologically meaningful.” But Séralini and colleagues reanalysed
the data in detail, using the appropriate statistical tests  and declared
MON 863 maize “unfit for consumption”  as it shows signs of being toxic
to the liver and kidney of rats. They called for “a moratorium on other approved
GMOs while the efficacy of current health testing methods is reassessed.”
They also wrote to the EFSA  to “urgently ask for a moratorium on MON 863.”
Séralini and colleagues found that the transgenic maize affected
the two sexes differently, which is often the case for effects due to pesticides
that disrupt sex hormones. A standard multivariate analysis showed a highly
significant and sustained 3.3 percent decrease in body weight in males, and
a 3.7 percent increase in females.
In addition, the kidneys were reduced in weight in males and the ionic composition
was modified in urine, as consistent with a disturbance in kidney function.
In females, there was a significant rise in blood sugar and triglycerides
as well as an increase in liver weight, also indicative of kidney and liver
Out of a total of 494 comparisons
besides body weight between GM fed and control groups, 40 (8 percent) showed
significant differences, whereas only 25 differences (5 percent) were expected
by chance alone.
The tests were insufficiently long term, and the hormonal
levels of the rats should have been investigated, Séralini said .
As Séralini and colleagues
point out in the case of MON 863, a new artificial protein Cry3Bb1 is produced
at relatively high levels (49 – 97 microgram/gram). Its mechanism of action
is not known in mammals because it was never studied, and the target receptor
has not even been characterised in insects. Most of all, unlike ordinary drugs
or pesticides, which have to be tested for three-months in three mammalian
species, then with one mammalian species for one year, and yet another for
2 years, current regulation does not require such tests for ‘biopesticides’
produced continuously in open fields; nor for the herbicides and herbicide
residues accumulated by herbicide-tolerant GM crops. The two traits, biopesticides
and herbicide tolerance now account for practically all GM crops grown in
the world today.