Parma, Italy
July 20, 2007
Opinion of the Scientific Panel
on Genetically Modified Organisms on an application (Reference
EFSA-GMO-NL-2005-18) for the placing on the market of the
glufosinate tolerant soybean A2704-12, for food and feed uses,
import and processing under Regulation (EC) No 1829/2003 from
Bayer CropScience
Last updated: 20 July 2007 Publication Date: 20 July 2007
Adopted on 3 July 2007. (Question Nº EFSA-Q-2005-174)
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 A2704-12
(Unique Identifier ACS-GMØØ5-3) developed to provide tolerance
to glufosinate herbicides.
In delivering its opinion the GMO Panel considered the
application EFSA-GMO-NL-2005-18, additional information provided
by the applicant (Bayer CropScience) and the scientific comments
submitted by the Member States. The scope of application
EFSA-GMO-NL-2005-18 is for food and feed uses, import and
processing of soybean A2704-12 and its derived products for the
same uses as any non-GM soybean (food, feed including meal, cake
and oil), excluding cultivation.
The GMO Panel assessed soybean A2704-12 with reference to its
intended uses. The assessment followed 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. The
scientific assessment included molecular characterization of the
inserted DNA and expression of the PAT protein. A comparative
analysis of agronomic traits and composition was undertaken. The
potential toxicity and allergenicity of the new protein was
evaluated together with the potential allergenicity of extracts
of whole food/feed. Environmental assessment was undertaken,
including a monitoring plan.
Soybean A2704-12 is derived from the soybean variety A2704 which
was transformed using particle bombardment. Soybean A2704-12
expresses the pat gene leading to the production of the enzyme
phosphinothricin acetyl-transferase (PAT) that acetylates
L-glufosinate-ammonium. The PAT enzyme confers tolerance to
glufosinate herbicides.
The molecular characterisation data established that soybean
A2704-12 contains a single insert. The insert contains all of
the sequences of plasmid vector pB2/35SAcK, including the vector
backbone consisting of pUC19 sequences. The insert also contains
two separate (3’ and 5’) fragments of the bla gene. These
fragments do not constitute a functional gene in soybean
A2704-12 and the bla gene was not expressed. Bioinformatics
analysis was carried out on open reading frames (ORFs) spanning
the insert, the insert/genomic junctions and the 5’
chloroplastic/genomic junction regions. This analysis showed
that it is unlikely that the eight putative ORFs are expressed
in soybean A2704-12. Even in the unlikely event that expression
did occur, any resulting polypeptides would show no significant
sequence homology with known toxins or allergens. The GMO Panel
is of the opinion that the molecular characterisation of the DNA
insert and flanking regions of soybean A2704-12 does not raise
safety concerns, and sufficient evidence for the stability of
the insert structure and of the newly introduced trait was
provided.
The GMO Panel assessed the results of the compositional analysis
of A2704-12 soybean and its comparator in the light of the field
trial design, measured biological variation and the level of the
studied compounds in conventional soybean varieties, and
concludes that A2704-12 soybean is compositionally equivalent to
the non-GM counterpart except for the introduced trait.
No toxicity of the PAT protein was observed in a single dose
acute toxicity study in mice using intravenous injection.
Furthermore, the PAT protein is rapidly degraded under simulated
gastric and intestinal conditions. The PAT protein shows no
homology with known toxic proteins and/or allergens. The PAT
protein has been extensively assessed in previous opinions of
the EFSA GMO Panel and no concerns were raised concerning the
safety of the PAT protein. Furthermore in vitro allergenicity
testing of extracts of A2704 12 soybeans showed no changes in
allergenicity.
The application EFSA-GMO-NL-2005-18 is for food and feed uses,
import and processing. There is therefore no requirement for
scientific information on possible environmental effects
associated with the cultivation of soybean A2704-12. Considering
the scope of the application, the GMO Panel is of the opinion
that the likelihood of the spread and establishment of soybean
A2704-12 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 monitoring plan
provided by the applicant and the reporting intervals are in
line with the intended uses of soybean A2704-12 since
cultivation is excluded.
In conclusion, taking into account all of the data assessed, the
GMO Panel considers that the information available for soybean
A2704-12 addresses the scientific comments raised by the Member
States and that the soybean A2704-12 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 A2704-12 is unlikely to
have any adverse effect on human and animal health or on the
environment in the context of its intended uses.
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