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APPROVAL / PHARMA CROPS: GE peas to combat infectious diseasesapproved for field testing in Germany

------------------------------- GENET-news -------------------------------
TITLE:  Novel feed: Peas to combat infectious diseases
SOURCE: GMO Safety, Germany
DATE:   25.04.2007

Novel feed: Peas to combat infectious diseases

The Federal Office of Consumer Protection and Food Safety (BVL) has
approved a field trial with genetically modified peas in Gatersleben
(Saxony-Anhalt) under certain conditions. Thanks to an inserted gene
construct, the GM peas produce antibodies against certain infectious diseases.

It is not the first time that GM plants that produce active
pharmaceutical substances have been tested on small areas in Germany.
Last year there was a field trial near Rostock involving various GM
potato lines, one of which contained an active substance that triggers
inoculation protection against a rabbit disease triggered by viruses.
This strategy - using plants as a production system for vaccines or
drugs, is being followed around the world by various research bodies and

Mixing antibiotics with animal feed has been banned in the EU for over a
year. They may be used only as animal medicine, but not to promote
growth or as a standard prophylaxis against infectious diseases.

The animal feed industry is therefore looking for new ways of protecting
animals against infectious diseases. In addition, a number of antibiotic
agents have become ineffective because mass use of them has led to the
spread of resistant pathogens.

Novoplant, one of the new plant biotech firms that have set up in the
area around the IPK (Leibnitz Institute of Plant Genetics and Crop Plant
Research) in Gatersleben, is working on a new approach. The aim is to
give feed crops the ability to produce antibodies against certain
infectious diseases by inserting suitable genes. If these GM plants are
mixed with the animal feed, the animals will ingest the antibodies.
These take the form of certain surface proteins of the pathogens,
thereby preventing them from attaching to the cells of the intestinal
wall. The antibodies present in the feed peas have the effect of a
'passive inoculation'. According to Novoplant, this means that they
supplement the animals' own immune system.

Feed to counter infectious diseases - ready for market by 2010?

Novoplant has developed four different GM pea lines that each produce
specific antibodies for a particular infectious disease. According to
Novoplant's managing director, Dieter Falkenburg, the first of these new
feed additives should be ready for market in 2010.

The furthest advanced are the GM peas for which Novoplant has now
applied for deliberate release authorisation. A complex gene construct
consisting of several elements has been introduced into the peas so that
they produce "single-chain antibodies". These bind to a particular site
on the surface of Escherichia coli bacteria , which trigger intestinal
infections in pigs. The antibodies are produced only in the seeds and
not in the rest of the plant.

The herbicide resistance (bar) gene used as a marker gene in an early
phase of the development is no longer present in the GM peas. It was
possible to remove the marker gene during selection of the progeny of
the parent line because the marker and target genes had been inserted
into the pea genome separately. This cotransformation process is one of
the new gene transfer methods that has been refined within biological
safety research and which make it possible to integrate only the target
gene and to remove DNA sequences that are needed only for technical reasons.

The trial in Gatersleben is to investigate whether the GM peas behave in
the same way in the open as they have done in greenhouse tests. Among
other things, the researchers are interested in the genetic stability of
the peas and the antibody yield that can be achieved under field
conditions. Novoplant also intends to use the trials to obtain plant
material to be used in animal trials. This pea line was tested in field
trials in the USA in 2005.

No gene bank propagation plots in release year

The approval covers the planting-out of 600 transgenic plants in the
2007 growing season on a site measuring 100 square metres. The BVL is
satisfied that the trial will have no harmful effects on humans, animals
or the environment. As a precaution, however, it has issued extra safety
conditions on top of the measures provided for in the trial application.

Peas are largely self-fertilising and have no relatives in Europe.
Outcrossings are unlikely, but cross-pollination by means of insects
cannot be entirely ruled out. The GM peas do not produce antibodies in
the pollen.

Around 75,000 people signed a petition protesting against the release
trial. They feared above all that GM peas might cross into the
Gatersleben gene bank populations. A proportion of the many pea samples
stored there is propagated each year in the open. The gene bank has
years of experience in preventing cross-contamination between the
different samples. In addition, the IPK will not cultivate any peas from
the gene bank's collection on the institute's fields during the year of
the release trial. Any agricultural cultivation of conventional peas
must be at least 1000 metres away from the trial plot.

In addition, the trial field must be shielded from small mammals and
birds. The GM peas must be harvested by hand and anything not required
for further research must be destroyed. In the year following the
release, the field is to be examined for emerging pea plants, and any
that emerge must be removed.

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