Brussels, Belgium
March 11, 2005
Summary
This document provides an opinion of the Scientific Panel on
Genetically Modified Organisms (GMO Panel) of
the European Food
Safety Authority (EFSA) on 1507 maize, genetically
modified to provide protection against specific lepidopteran
pests. The maize also contains a gene providing tolerance to the
herbicide glufosinate.
In delivering its opinion the Panel considered the application,
additional information provided by the applicant and comments
submitted by the Member States. Further information from other
applications for placing 1507 maize on the market under current
regulatory procedures were taken into account where appropriate,
as were comments from the Member States. The information from
other applications were notification C/ES/01/01 for cultivation,
import, processing and use as any other maize (excluding food
uses) and notification C/NL/00/10 for import and processing. For
regulatory reasons the latter applications resulted in separate
opinions.
1507 maize was assessed with reference to its intended use
employing the appropriate principles as 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 examination of the DNA inserted into 1507
maize and the nature and safety of the target proteins produced
by the transgenic plants with respect to toxicology and
allergenicity. Furthermore, a comparative analysis of agronomic
traits and composition was undertaken and the safety of the
whole food was evaluated. A nutritional and an environmental
assessment, including monitoring plan, were both undertaken.
1507 maize has been developed for protection against specific
lepidopteran pests such as the European corn borer (Ostrinia
nubilalis) and Sesamia spp. and for tolerance to the herbicide
glufosinate. Insect resistance is achieved by production of a
truncated Cry1F protein from Bacillus thuringiensis ssp. aizawai
and tolerance to the herbicide is conferred by a
phosphinothricin-N-acetyltransferase (PAT) from Streptomyces
viridochromogenes. Maize embryos were transformed by particle
bombardment to transfer a DNA fragment containing these two
genes. As a result of the genetic modification, the 1507 event
contains an insert bearing both cry1F and pat genes, under the
control of the maize ubiquitin and the 35S promoters,
respectively.
Molecular analysis showed that 1507 maize contains one copy of
the DNA fragment used for transformation and that this is
present at a single locus in the nuclear genome of the GM plant.
The complete DNA sequence of the insert was provided. In
addition to the intact genes, the insert in 1507 maize includes
DNA sequences originating from the fragment used for
transformation as well as maize chloroplast and nuclear genome
sequences at both ends of the inserted sequence. While these
sequences may have resulted from the transformation process
(insertional events), there were no indications that these
additional fragments would result in the transcription of new
RNA other than the mRNAs transcribed from the cry1F and pat
genes. In the unlikely event that this does occur,
bioinformatics analysis showed that any resulting peptides or
proteins would have no homology to known toxins or allergens.
Analysis of DNA sequences flanking both ends of the insert shows
that they correspond to maize genomic DNA.
Analysis of kernel chemical composition from field trials in
South America and Europe showed that 1507 maize was
substantially equivalent to its non-GM comparator. Furthermore,
appropriate animal feeding trials indicated that 1507 maize is
nutritionally equivalent to its non-GM comparator.
Application EFSA-GMO-NL-2004-02 only concerns food uses for 1507
maize. Therefore, there is no requirement for scientific
information on possible environmental effects associated with
the cultivation of the GM maize. The GMO Panel agrees that
unintended environmental effects due to the establishment and
spread of GM maize will not be different from those of maize
bred traditionally. The monitoring plan provided by the
applicant is in line with the intended uses for the GMO.
In conclusion, the GMO Panel considers that the information
available for 1507 maize addresses the outstanding questions
raised by the Member States and considers that 1507 maize will
not have an adverse effect on human and animal health or the
environment in the context of its proposed use.
This scientific opinion corresponds to the risk assessment
report requested under Article 6(6) of Regulation (EC) No
1829/2003 and will be part of the overall opinion as required by
Regulation (EC) No 1829/2003. |
