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RISK ASSESSMENT / FOOD: EFSA statement on the recent CRIIGENpublication on MON 863 maize

please read more about CRII-GEN, the "Comité de Recherche et d'Information
Indépendantes sur le Génie Génétique", at:
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TITLE:  EFSA statement on the recent CRIIGEN publication on MON 863 maize
SOURCE: European Food Safety Authority, France
AUTHOR: Press Release
DATE:   15.03.2007

EFSA statement on the recent CRIIGEN publication on MON 863 maize

EFSA is aware of the recently presented publication by the CRIIGEN
research group on genetically modified maize MON 863 containing a
revised statistical analysis of the 90 day rat study considered in the
risk assessment. EFSA will carefully evaluate this new publication and
its new statistical analysis including any possible significance this
publication may have on the risk assessment of MON 863. MON 863 maize
has been subject to a comprehensive risk assessment by EFSA and by other
authorities which did not identify any adverse effects on human and
animal health or the environment. The 90 day rat study analysed by
CRIIGEN is one element of the comprehensive risk assessment of MON863
maize. The CRIIGEN analysis findings on MON 863 will be discussed by the
GMO Panel at its next meeting to be held in Parma on 22/23 March 2007.

[1] Committee for Independent Research and Genetic Engineering
[2] and
[3] Australia/New Zealand:
[4] Canada:
[5] France:

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TITLE:  EFSA to review Monsanto maize concerns
SOURCE: Food Navigator, France
AUTHOR: Stephen Daniells
DATE:   15.03.2007

EFSA to review Monsanto maize concerns

15/03/2007 - The European Food Safety Authority (EFSA) has revealed that
it will review the new data presented by French scientists that revealed
toxicity concerns in rats fed the MON863 variety of GM maize from Monsanto.

The new data, from a 90-day rat study and published in the peer-review
journal Archives of Environmental Contamination and Toxicology,
indicated liver and kidney toxicity in the rats, as well as differences
in weight gain between the sexes as a result of eating the transgenic maize.

Alun Jones, EFSA spokesperson told that the authority
has not yet had the opportunity to look at the new study in detail but
this will be done by their scientific experts before any decisions is
made regarding the maize.

The GMO panel will meet on March 22nd and 23rd to consider and discuss
the new study.

Jones also stated that this was not the first time that EFSA have been
requested to look at MON863. Indeed, the authority released a statement
in October 2004 following a request by the German authorities following
a 13-week rat study that suggested kidney toxicity.

"Following [the GMO Panel's] investigation of the report, and of the
retrospective evaluation of renal tissues and data derived from the 13-
week rat feeding study performed by independent peer reviewers, the GMO
Panel concludes that there is no evidence presented in the report that
changes the conclusions already reached by the GMO Panel earlier this
year in its Opinions on the safety of the insect-protected genetically
modified maize MON 863 (EFSA 2004a, b)," read the October 2004 statement.

"These opinions state that the results of the rodent toxicity study with
MON 863 maize did not indicate concerns about its safety for human and
animal consumption."

The researchers behind the new study, led by Professor Gilles Eric
Séralini from the independent CRIIGEN (Committee for Independent
Research and Genetic Engineering) based at the University of Caen
questioned the methods used by Monsanto to initially show the safety and
non-toxicity of the corn, saying that the statistical methods used were
insufficient to observed any possible disruptions in biochemistry.

"Monsanto's analyses do not stand up to rigorous scrutiny - to begin
with, their statistical protocols are highly questionable. Worse, the
company failed to run a sufficient analysis of the differences in animal
weight. Crucial data from urine tests were concealed in the company's
own publications," said Séralini during a joint press conference with
environmental group Greenpeace in Berlin.

Monsanto have continued to defend the safety record of their corn.
Spokesperson, Lee Quarles, told "The important thing
to note in all of this is the fact that the overwhelming opinion of
expert authorities is that MON 863 is safe for human and animal
consumption. This includes experts in Europe as the European competent
authorities concur that MON 863 YieldGard Rootworm maize is safe for
human and animal health and the environment.

"Please also note that MON 863 YieldGard Rootworm maize has completed
full regulatory review and has been grown commercially in the United
States and Canada since 2003. This product has also been approved for
import and food use in many countries around the world, including Japan,
Korea, Taiwan, the Philippines, Russia and Mexico," he added.

MON863 is a transgenic maize genetically modified to express the Bt-
toxin (Cry3Bb1) which enables the plant to be insect repellent against
the corn rootworm pest. It is different from other GM corns of the
market since these express the Cry1Ab toxin which is toxic to the
European corn borer.

It received European approval for use in animal feed in 2005 and for
human consumption in 2006.

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