Parma, Italy
June 28, 2007
Link to source
At the request of the European
Commission (EC), the European Food
Safety Authority (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
http://www.efsa.europa.eu/en/about_efsa/structure/who_is_who/home_cgl/correspondence.html
The GMO Panel statement
http://www.efsa.europa.eu/en/science/gmo/statements0/gmo_statement_mon863_ratfeeding.html
EFSA statistical analysis of the Monsanto data
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
http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/383.Par.0001.File.dat/opinion_gmo_07_en1.pdf
Statement of
the Scientific Panel on Genetically Modified Organisms on the
analysis of data from a 90-day rat feeding study with MON 863
maize
Link to source
In 2004 the Panel on Genetically
Modified Organisms (GMO Panel) of the European Food Safety
Authority (ESFA) gave its opinion on the safety of MON 863 maize
for import and processing, food and feed uses (EFSA, 2004a,b)
and released a statement on the same topic shortly after (EFSA,
2004c). In these documents it was concluded that the MON 863
maize would not have an adverse effect on human and animal
health or the environment in the context of its proposed use.
One of the studies assessed by the Panel was a 90-day
(subchronic) feeding study in rats using kernels of MON 863
maize (Monsanto, 2002).
Since then, two scientific papers dealing with this study have
been published (Hammond et al., 2006; Séralini et al., 2007).
Hammond et al. (2006) described the study and its outcomes, but
in less detail than the original report provided by Monsanto
(2002). Séralini et al. (2007) published a statistical
re-analysis of the original data from Monsanto and concluded
that ‘with the present data it cannot be concluded that GM corn
MON 863 is a safe product’. The European Commission asked EFSA
on 15 March 2007 to consider, in cooperation with the Member
States, what impact the re-analysis might have on the earlier
opinions and statement of the GMO Panel (EFSA, 2004a,b,c). In
response to the question from the European Commission, EFSA set
up a Task Force to assess the statistical methodology applied by
Séralini et al. (2007), and to perform an additional statistical
analysis. The outcome of the Task Force’ analysis is reported in
a document entitled: “EFSA review of statistical analyses
conducted for the assessment of the MON863 90-day rat feeding
study” (EFSA, 2007). In addition EFSA asked Member States
whether there were any further relevant data or views on the
Monsanto study and its statistical approach. EFSA also convened
a technical meeting with the authors of the paper (Séralini et
al. 2007) in order to have a full understanding of their
statistical considerations and approaches.
RELATED RELEASE:
EFSA bleibt dabei: Keine Bedenken
bei Bt-Mais MON863 |
|
