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
Source:
EFSA reaffirms its risk assessment of genetically modified maize MON 863.
European Food Safety Authority Press Release (28.6.07) (http://www.efsa.europa.eu/en/press_room/press_release/pr_efsa_maize_Mon863.html)
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