Date of publication: March 16,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/FR/06/03/03
Member State:France
Date of Acknowledgement:
Title of the Project:
Field experimentation of genetically modified corn expressing
a gastric lipase for medical uses.
Proposed period of release From:01/04/2006
To:31/10/2006
Name of the Institute(s) or Company(ies): Meristem
Therapeutics;
3. Is the same GMPt release planned elsewhere in the
Community?
No
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
B/FR/00/02/07; B/FR/05/02/01
Genetically
modified plant
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| maize
|
poaceae |
zea
|
zea
mays |
mays
|
Hybrid
seeds with cytoplasmic male sterility |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
The genes introduced confer to the maize:
- Ability to produce a gastric lipase in seeds
- Tolerance to glufosinate
There have been no previous genetic modifications of the
parental organism.
Genetic
modification
3. Type of genetic
modification:
Insertion;
4. In case of insertion of genetic material, give the source
and intended function of each constituent fragment of the region
to be inserted:
A binary plasmid which was introduced in a disarmed
Agrobacterium strain has been used. The vector contains:
- A gene fusion between the signal peptide sequence from a
rabbit protein precursor and a sequence that encodes a dog
gastric lipase (seed specific expression). This enzyme catalyses
the hydrolysis of alimentary long-chain triglycerides in vivo
- The bar coding sequence from Streptomyces hygroscopicus. This
gene used as a selective marker confers tolerance to glufosinate
ammonium (constitutive expression).
6. Brief description of the method used for the genetic
modification:
The method used is the biologic transformation by
Agrobacterium tumefaciens.
7. If the recipient or parental plant is a forest tree
species, describe ways and extent of dissemination and specific
factors affecting dissemination:
Not Applicable
Experimental
Release
1. Purpose of the release:
Previous field experimentations have allowed the extraction
and purification of recombinant lipase from corn. This
recombinant gastric lipase has been used to realize
toxicological studies carried out on animals, clinical studies
phase I carried out on healthy volunteers (men and women) and
clinical studies phase IIa carried out on patients reached by
cystic fibrosis. These studies showed:
- No toxicity of the gastric lipase ingested in great quantity,
- A good tolerance of the gastric lipase in single and repeated
oral administration,
- A significant improvement of the absorption of the lipids for
the sick subjects.
The goal of this release is to produce enough grains producing
gastric lipase in order to:
o continue the clinical studies necessary to obtaining the
marketing authorization with the purified recombining lipase
produced,
o continue galenic studies,
o optimize our know how on Plant Made Pharmaceutical production
in order to reach regulatory requirements applicable to the
obtention of active ingredients for therapeutic uses.
2. Geographical location of the site:
In 2006 the releases are planned in the center of France (Puy
de Dôme, Auvergne).
3. Size of the site (m2):
Puy de Dôme: 70 000 m2 shared on 1 site (including non
transgenic border rows, and non transgenic maize used as
pollinators for biomass production plot).
4. Relevant data regarding previous releases carried out with
the same GM-plant, if any, specifically related to the potential
environmental and human health impacts from the release:
Field experimentations were already conducted in several
locations in France and abroad with the same event of
transformation. These field experimentations (productions of
seeds and biomass) were carried out during the years 2000, 2001,
2002, 2003 and 2005 on field from a few hundreds of square
meters to around thirteen hectares and no environmental problems
were reported for these trials.
The handling of the GMPts is daily; since many years many people
are in contact with these GMPts whatever the environment :
laboratory, greenhouse, field, pilot unit and, up to today,
nobody noted to have a problem of health and in particular an
allergy of contact.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
Introduced traits do not modify the plant persistency in the
environment, the ability to survive, the capacities of
dissemination. Even if these GMPts are tolerant to the
glufosinate ammonium, this benefit of selection can’t be
maintained in French agro systems because of the non use of
glufosinate ammonium on commercial crops. Without pression of
selection, the selective advantage cannot be maintained.
No selective advantage is conferred by the expression of a
gastric lipase in seeds of GMPts.
There is no wild species sexually compatible with maize in
Europe so potential interspecific crossings are not possible in
these sites. The only potential crossing can be between GMPts
and conventional maize. However this type of crossing is very
improbable due to the fact that measures are taken for the
control of non intentional release in the environment and pollen
dissemination (Cf. paragraph E).
In previous experiments, there was no direct or indirect
negative or positive impact observed on non-target organisms.
Moreover, the whole of the toxicological studies carried out on
animals and clinical studies carried out on humans have not
showed any toxicity of the gastric lipase.
Except the specific cultivation management, the techniques of
cultivation used are the same ones as those usually used for
conventional maize production. So no supplemental effect is
expected for environment.
To our knowledge, no risks to human and animal health or the
environment from the deliberate release of genetically modified
maize expressing a gastric lipase and tolerant to glufosinate
ammonium herbicide have been reported.
Brief description of any measures taken for the management of
risks:
- For biomass production (transgenic plants are male sterile
or detasseled), a 200 meters isolation distance will be
maintained to any other commercial corn crop.
- At least 4 border rows of non transgenic maize will be sown
all around this experimental field.
- Use of a cytoplasmic male sterility system for the production
of biomass.
- Destruction by crushing of the residues of culture at the end
of the harvest.
- Monitoring of possible volunteers during one year after
harvest.
- The surrounding of the plot will be cleaned.
- No commercial corn culture will be established on this
experimental field the following year.
- Maize will not be used for feed or food.
The regular follow-up of the trial makes it possible to identify
in an early way any event or development which is not desirable.
Thus the trial can be stopped quickly by the classic means of
destruction (chemical treatment with a conventional total
herbicide other than the glufosinate ammonium or mechanical
treatment with crusher for example).
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
Not applicable
Final report
-
European
Commission administrative information
Consent given by the Competent
Authority: Not Known |
