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RISK ASSESSMENT: EFSA rejects concerns over Monsanto maize MON863




                                  PART 1


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TITLE:  EFSA REJECTS CONCERNS OVER MONSANTO MAIZE

SOURCE: Food Production Daily, France

AUTHOR: Stephen Daniells

URL:    http://www.foodproductiondaily.com/news/ng.asp?n=77768-monsanto-efsa-gmo-mon

DATE:   29.06.2007

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EFSA REJECTS CONCERNS OVER MONSANTO MAIZE

29/06/2007 - The European Food Safety Authority’s (EFSA) GMO panel has no safety concerns after reviewing data from French scientists suggesting toxicity concerns in rats fed the MON863 variety of GM maize from Monsanto.

”Following a detailed statistical review and analysis by an EFSA Task Force, EFSA’s GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns,” stated the authority.

The statement draws a line under the issue, raised when new data from a 90-day rat study, published in the peer-review journal Archives of Environmental Contamination and Toxicology in March, 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.

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. The corn is also authorised in Australia, Canada, China, Japan, Mexico, the Philippines and the USA.

In the US, no re-evaluation of the data was announced by FDA.

The researchers behind the 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 in March during a joint press conference with environmental group Greenpeace in Berlin.

After re-evaluating the safety data relating to MON863, EFSA however have come to different set of conclusions, stating:

”The statistical analysis made by the authors of the paper did not take into account certain important statistical considerations. The assumptions underlying the statistical methodology employed by the authors led to misleading results.

”EFSA considers that the paper does not present a sound scientific justification in order to question the safety of MON 863 maize.

”Observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA, were considered not to be biologically relevant. In the absence of any indications that the observed differences are indicative of adverse effects, the GMO Panel does not consider that this paper raises new issues with respect to the safety of MON 863 maize.

”Therefore, the GMO Panel sees no reason to revise its previous Opinions that the MON 863 maize would not have an adverse effect in the context of its proposed use,” said the authority.

This was not the first time that EFSA was 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.



                                  PART 2

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TITLE:  EFSA REAFFIRMS ITS RISK ASSESSMENT OF GENETICALLY MODIFIED MAIZE MON 863

SOURCE: European Food Safety Authority, Italy

AUTHOR: Press Release

URL:    http://www.efsa.europa.eu/en/press_room/press_release/pr_efsa_maize_Mon863.html

DATE:   28.06.2007

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EFSA REAFFIRMS ITS RISK ASSESSMENT OF GENETICALLY MODIFIED MAIZE MON 863

At the request of the European Commission (EC), EFSA has examined a paper by Séralini et al. on the statistical evaluation of a 90-day feeding study in animals with genetically modified maize MON 863, to identify any consequences for EFSA’s risk assessment of the safety of MON 863. The paper presents an alternative statistical analysis of the 90-day rat study that was considered in the original risk assessment. Following a detailed statistical review and analysis by an EFSA Task Force, EFSA’s GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns.

At the request of the European Commission (EC), EFSA has examined a paper by Séralini et al. on the statistical evaluation of a 90-day feeding study in animals with genetically modified maize MON 863, to identify any consequences for EFSA’s risk assessment of the safety of MON 863.[1] The paper presents an alternative statistical analysis of the 90-day rat study that was considered in the original risk assessment. Following a detailed statistical review and analysis by an EFSA Task Force, EFSA’s GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns.

EFSA undertook a series of actions to give a considered response to the European Commission on this issue:

- Member States (MS) were asked to provide any analyses and comments that may contribute to consideration of this issue.

- EFSA set up a Task Force of internal and external statistical experts to help assess the statistical methodology applied by authors of the publication in their re-analysis of the original data from the 90-day rat feeding study and to consider the contributions received from MS. As part of that work a meeting was held with the authors of the paper.

- EFSA’s GMO Panel has reviewed all the available evidence.

Following this work, EFSA has responded to the Commission, published a statistical report and issued a scientific statement from its GMO Panel. The main conclusions are:

- The statistical analysis made by the authors of the paper did not take into account certain important statistical considerations. The assumptions underlying the statistical methodology employed by the authors led to misleading results.

- EFSA considers that the paper does not present a sound scientific justification in order to question the safety of MON 863 maize.

- Observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA, were considered not to be biologically relevant. In the absence of any indications that the observed differences are indicative of adverse effects, the GMO Panel does not consider that this paper raises new issues with respect to the safety of MON 863 maize. Therefore, the GMO Panel sees no reason to revise its previous Opinions that the MON 863 maize would not have an adverse effect in the context of its proposed use.

Prior to this most recent work, 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 this paper is one element of the comprehensive risk assessment of MON863 maize. In addition to the original Opinion in April 2004, this study has been reviewed again twice since then, prior to this recent work.

The letter to the Commission, the GMO Panel statement, EFSA statistical analysis of the Monsanto data are available on the EFSA website at the following links:

- Letter to the Commission at

http://www.efsa.europa.eu/en/about_efsa/structure/who_is_who/home_cgl/correspondence.html

- The GMO Panel statement at

http://www.efsa.europa.eu/en/science/gmo/statements0/gmo_statement_mon863_ratfeeding.html

- EFSA statistical analysis of the Monsanto data at

http://www.efsa.europa.eu/en/science/scientific_reports/statistical_analyses_MON863.html

 

[1] The scientific opinions are available at EFSA website at

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/381.Par.0001.File.dat/opinion_gmo_06_en1.pdf an

 http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/383.Par.0001.File.dat/opinion_gmo_07_en1.pdf


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