Opinion of
the Scientific Panel on Genetically Modified
Organisms on application (reference
EFSA-GMO-NL-2006-36) for the placing on the
market of the glyphosate-tolerant
genetically modified soybean MON89788, for
food and feed uses, import and processing
under Regulation (EC) No 1829/2003 from
Monsanto[1]
Question
number: EFSA-Q-2006-182
Summary
This document provides an opinion
of the Scientific Panel on Genetically
Modified Organisms (GMO Panel) of the
European Food Safety Authority (EFSA) on
genetically modified soybean MON89788
(Unique Identifier MON-89788-1) developed to
provide tolerance to glyphosate by
expressing the CP4 EPSPS protein.
In delivering its scientific opinion, the
GMO Panel considered the new application
EFSA-GMO-NL-2006-36, additional information
provided by the applicant (Monsanto) and the
scientific comments submitted by the Member
States. The scope of application
EFSA-GMO-NL-2006-36 is for food and feed
uses, import and processing of soybean
MON89788 and all derived products, but
excluding cultivation in the EU.
The GMO Panel assessed soybean MON89788 with
reference to the intended uses and the
appropriate principles described in the
Guidance Document of the Scientific Panel on
Genetically Modified Organisms for the risk
assessment of genetically modified plants
and derived food and feed (EFSA, 2006). The
scientific assessment included molecular
characterization of the inserted DNA and
expression of the new protein. A comparative
analysis of agronomic traits and composition
was undertaken and the safety of the newly
expressed protein and the whole food/feed
was evaluated with respect to potential
toxicity, allergenicity and nutritional
quality. An assessment of environmental
impacts and the post-market environmental
monitoring plan were undertaken.
Soybean MON89788 was transformed by
Agrobacterium tumefaciens-mediated gene
transfer technology. Soybean MON89788
expresses the codon-optimized epsps from
Agrobacterium sp. strain CP4 encoding CP4
EPSPS that confers glyphosate tolerance to
the plant.
The molecular characterisation data
established that a single insert with one
copy of the intact cp4 epsps expression
cassette is integrated in the soybean
genomic DNA. Appropriate analyses of the
integration site including sequence
determination of the inserted DNA and
flanking regions and bioinformatics analysis
have been performed. Bioinformatics analysis
of junction regions demonstrated the absence
of any potential new ORFs coding for known
toxins or allergens. The expression of the
genes introduced by genetic modification has
been sufficiently analysed and the stability
of the genetic modification has been
demonstrated over several generations. The
GMO Panel is of the opinion that the
molecular characterisation of the DNA insert
and flanking regions of soybean MON89788
does not raise any safety concern, and that
sufficient evidence for the stability of the
genetic modification was provided.
The GMO Panel compared the composition and
agrono¬mic characteristics of soybean
MON89788 and its non-GM counterpart,
assessed all statistical differences
identified, and came to the conclusion that
soybean MON89788 is compositionally
equivalent to conventional soybean lines,
except for the introduced transgenic trait.
The risk assessment included an analysis of
data from analytical studies,
bioinformatics, and in vitro and in vivo
studies. The GMO Panel concluded that the
soybean MON89788 is as safe as its non GM
counterpart and that the overall
allergenicity of the whole plant is not
changed.
The application for soybean MON89788
concerns food and feed uses, import and
processing of soybean MON89788 and all
derived products, but excluding cultivation
in the EU. There is therefore no requirement
for scientific assessment of possible
environmental effects associated with the
cultivation of soybean MON89788. Considering
the scope of the application, not for
cultivation, the GMO Panel is of the opinion
that the likelihood of the spread and
establishment of soybean MON89788 is very
low and that unintended environmental
effects due to this soybean will be no
different from that of conventional soybean
varieties. The scope of the post-market
environmental monitoring plan provided by
the applicant is in line with the intended
uses of soybean MON89788. The monitoring
plan provided by the applicant is in line
with the EFSA Guidance Document (EFSA, 2006)
and the Opinion of the GMO Panel on
post-market environmental monitoring (EFSA,
2006).
In conclusion, the GMO Panel considers that
the information available for soybean
MON89788 addresses the scientific comments
raised by the Member States and that the GM
soybean MON89788 is as safe as its non
genetically modified counterpart with
respect to potential effects on human and
animal health or the environment. Therefore
the GMO Panel concludes that soybean
MON89788 is unlikely to have any adverse
effect on human or animal health or on the
environment in the context of its intended
uses.
Opinion
www.efsa.europa.eu/EFSA/Scientific_Opinion/gmo_op_ej758_soybeanMON89788_en,0.pdf
[1] For citation purposes: Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2006-36) for the placing on the market of glyphosate-tolerant soybean MON89788 for food and feed uses, import and processing under Regulation (EC) 1829/2003 from Monsanto, The EFSA Journal (2008) 758, 1-23.