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[ Print article using a 'typewriter' font (like Courier) 809 words ]

GM Maize MON 863 Toxic
----------------------

by Dr. Mae-Wan Ho
ISIS Press Release
Thursday 3 May 2007

French scientists find signs of toxicity to
liver and kidney in Monsanto's study on its
controversial GM maize.

[A fully referenced version of this article is
posted on ISIS members' website.

An electronic version of this report, or any
other ISIS report, with full references, can be
sent to you via e-mail for a donation of £3.50.
Please e-mail the title of the report to: report
at i-sis.org.uk]

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 Seralini 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 Seralini 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."

Seralini 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 malfunction.

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, Seralini said.

Large gaps in health assessment

There are large gaps in current health assessment of GM food and feed
(see "GM Food Nightmare Unfolding in the Regulatory Sham", ISIS
scientific publication, also SiS 33).

As Seralini 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.

http://www.i-sis.org.uk/GMmaizeMON863toxic.php

( The Institute of Science in Society )

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