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Notification report


General information

Notification Number
B/DE/06/182

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
27/09/2006

Title of the Project
Antibody production in feed pea

Proposed period of release:
01/05/2007 to 30/09/2007

Name of the Institute(s) or Company(ies)
Novoplant GmbH, ;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
peafabaceaepisumpisum sativumEiffel

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Pisum sativum var. Eiffel, expressing a single chain antibody (scFv) in the seed, no marker gene, single insert of antibody gene

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Vicia faba USP(+) promoter controls seed specific expression
Vicia faba Legumin B4 signal peptide targets the protein to the Endoplasmatic Reticulum (ER)
Sequences derived from mouse encoding the antibody fragment BA11
The synthetic sequence encoding Hexa histidine tag for detection of antibody – used for purification and determination of expression
The synthetic sequence encoding the KDEL signal for retention of the antibody in the ER
The CaMV 35S terminator from the Cauliflower mosaic virus for transcript termination
Left and right border sequences from Agrobacterium tumefaciens


6. Brief description of the method used for the genetic modification:
Insertion of foreign DNA by Agrobacterium mediated gene transfer

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:
The colonization of the swine small intestine by E. coli, expressing adhesion proteins (F4 fimbriae), causes toxin release, which results in diarrhea. As antibiotic use in animal feed becomes more and more restricted, passive immunization with antibodies provides a safe and effective alternative for interfering with pathogen colonization of the intestine and prevention of infectious disease outbreaks. Purpose of the release is to provide - together with material from ongoing greenhouse expression – sufficient antibody expressing pea seed for further animal testing, especially dose/effect studies. Furthermore, formulation studies for developing pea seeds into a feed pellet shall be pursued.
The release in the field should further confirm results from greenhouse grown plants, regarding plant growth, genetic stability, susceptibility to plant diseases, survivability, yield, antibody expression level and seed specificity of antibody expression.


2. Geographical location of the site:
Germany, Saxony Anhalt, administrative district Aschersleben-Staßfurt, 06466 Gatersleben, area of the Institute for Plant Genetics and Crop Plant Research

3. Size of the site (m2):
total site 1000 m2, thereof approx. 100 m2 actual plot size for planting of transgenic pea together with wild type

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:
No impact on environmental and human health was detectable in the field trial in the USA during the vegetation period of 2006.
Antibody expression was seed specific and the level of expression was comparable to greenhouse grown plants. No outcrossing was detected in randomly taken seed samples from border row peas.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
From our present knowledge we do not expect any increased selective advantage in natural environments. Peas are strictly self pollinating and seed loss during the trial is prevented by several measures (listed below). If any seed is consumed by animals, no impact on the health of these organisms is expected, because the antibody binding is highly specific to F4 fimbriae of enterotoxigenic E. coli. Furthermore they will be digested during their passage through the gastrointestinal tract. Therefore and especially because of the risk assessment in combination with the planned measures (listed at point E) no impact on the environment is expected.

Brief description of any measures taken for the management of risks:
Planting, sampling and harvesting will be done by hand.
The plot will be fenced in.
The whole plot will be covered by a net which prevents seed dispersal by birds.
Plants will be additionally covered by a second net to prevent seed loss.
Harvested seed material will be transported under containment (closed boxes).
Daily control of the site.
Late planting results in temporal isolation regarding the flowering timepoint.
After termination of the trial the field will lie idle for two years, or a plant species will be planted which allows easy detection of any volunteer pea plant upcoming in the following two years.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
United States of America during the vegetation period of 2007, application submitted

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/04/2007 00:00:00
Remarks: