2-Plants: EFSA opinion on GE maize Bt11

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TITLE:  Opinion of the GMO Panel related to the notification for the
        placing on the market of insect resistant genetically modified
        maize Bt11, for cultivation, feed and industrial processing
SOURCE: European Food Safety Authority
        http://www.efsa.eu.int/science/gmo/gmo_opinions/922_en.html
DATE:   20 May 2005

------------------- archive: http://www.genet-info.org/ -------------------


Opinion of the GMO Panel related to the notification for the placing on
the market of insect resistant genetically modified maize Bt11, for
cultivation, feed and industrial processing

Adopted on 20 April 2005
(Question No EFSA-Q-2004-012)

Opinion
http://www.efsa.eu.int/science/gmo/gmo_opinions/922/
gmo_opinion_ej213_bt11maize_cultivation_en1.pdf

Summary
http://www.efsa.eu.int/science/gmo/gmo_opinions/922/
gmo_opinion_ej213_bt11maize_cultivation_summary_en1.pdf

Summary of the Opinion

This document provides an opinion of the Scientific Panel on Genetically
Modified Organisms (GMO Panel) of the European Food Safety Authority
(EFSA) on Bt11 maize, genetically modified to provide protection against
specific lepidopteran pests. The maize also contains a gene providing
tolerance to the herbicide glufosinate.

The opinion is based on a question raised by the Commission relating to
an application for the placing on the market of Bt11 maize under
Directive 2001/18/EC. The GMO Panel was asked to consider whether there
is any scientific reason to believe that placing Bt11 maize on the
market, for cultivation, import, processing and use as any other maize
(excluding food uses), is likely to cause any adverse effects on human
health and the environment (Notification C/F/96/05.10). The question
followed a scientific assessment which was made initially by the
Competent Authority of France and evaluated subsequently by all other
Member States. An assessment of the Bt11 maize was requested by the
Commission because of questions raised by several Member States following
the evaluations at the national level. When this is the case, EU
legislation requires that EFSA carries out a further assessment and
provides an opinion.

Bt11 maize has been previously evaluated (SCP, 1998a) and approved (EC,
1998) for import, processing and feed use under Directive 90/220/EEC.
Bt11 maize has also been evaluated for cultivation under the same
Directive (SCP, 2000). Food and food ingredients derived from Bt11 maize
have been authorised (EC, 1999) pursuant to Article 5 of Regulation (EC)
258/97. Bt11 sweet maize has also been evaluated (SCF, 2002) and approved
(EC, 2004c) for food consumption in the framework of Regulation (EC) 258/
97 (EC, 1997).

In delivering its opinion the Panel considered the application,
additional information provided by the applicant and comments submitted
by the Member States. Bt11 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' (EFSA, 2004a). The scientific assessment included
examination of the DNA inserted into Bt11 maize and the nature and safety
of the newly expressed 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 product was evaluated. A nutritional and an
environmental assessment, including monitoring plan, were both undertaken.

Bt11 maize has been developed for protection against specific
lepidopteran pests such as the European corn borer (Ostrinia nubilalis)
and Sesamia spp. Though the applicant considered that the pat gene for
glufosinate ammonium tolerance was a marker gene and would only be used
for that purpose, the Panel considered it likely that farmers would grow
Bt11 maize with glufosinate herbicide applications. The Panel therefore
decided that the environmental risk assessment and the post marketing
environmental monitoring should also consider the direct and indirect
impacts of the herbicide tolerance trait.

Insect resistance is achieved by production of a variant Cry1Ab protein
from Bacillus thuringiensis and tolerance to the herbicide is conferred
by a phosphinothricin-N-acetyltransferase (PAT) from Streptomyces
viridochromogenes. Maize protoplasts were transformed with a DNA fragment
containing two expression cassettes. As a result of the genetic
modification, the Bt11 event contains an insert bearing both cry1Ab and
pat genes, under the control of the 35S promoter.

Molecular analysis showed that Bt11 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. There is no evidence for the presence of partial
insertions of amp gene sequences or non-coding vector backbone sequences.
Analysis of DNA sequences flanking both ends of the insert shows that
they correspond to maize genomic DNA. The insertion of the DNA fragment
bearing both cry1Ab and pat genes does not disrupt any endogenous maize
open reading frame. The genetic stability of the inserted DNA in event
Bt11 was demonstrated and segregation data for the PAT and Cry1Ab traits
were shown to follow Mendelian genetics.

Based on the results of compositional analysis, it is concluded that
forage (silage) and kernels of Bt11 maize are compositionally equivalent
to those of conventional maize, except for the presence of Cry1Ab and PAT
proteins in Bt11 maize. No indications were found that unintended effects
have occurred in Bt11 maize.

Notification C/F/96/05.10 concerns cultivation, import, processing and
use as any other maize, excluding food uses. Bt11 maize is comparable
with maize bred traditionally, except for the expression of tolerance to
glufosinate herbicide and resistance to certain lepidopterans. Maize does
not colonise and rarely survives outside the cultivated environment. It
is winter-hardy only in parts of Southern Europe, and it has no cross-
compatible wild relatives in Europe. Therefore, no unintended
environmental effects due to the establishment and spread are
anticipated. The likelihood of adverse effects on non-target organisms or
on soil functions due to the expression of the cry1Ab gene or the pat
gene is considered to be very low. The presence of the pat gene and the
use of glufosinate ammonium are not likely to give an additional
botanical diversity effect compared to other herbicides. The possible
development of resistance of target organisms to Bt toxin has been
identified as a potential risk due to large scale cultivation and/or long
term exposure. Thus, an appropriate case-specific monitoring plan to
record the development of resistance has been provided. In addition, the
GMO Panel agrees in principle with the approach proposed by the applicant
in the general surveillance plan.

From the data provided by the applicant, there was no evidence to
indicate that Bt10 material was present in the Bt11 maize used for the
biosafety studies. Therefore, the GMO Panel considers that the risk
assessment of Bt11 maize has not been compromised by the presence of Bt10
maize.

In conclusion, the Panel considers that the information available for
Bt11 maize addresses the outstanding questions raised by the Member
States and considers that Bt11 maize will not have an adverse effect on
human and animal health or the environment in the context of its proposed use.

Keywords: GMO, maize, Zea mays, Bt11, insect resistance, Cry1Ab, PAT,
feed safety, human health, cultivation, environment, import, Regulation
(EC) 258/97, Directive 90/220/EEC, Directive 2001/18/EC.

Publication date: 19 May 2005




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