BASF Plant Science GmbH

SUMMARY NOTIFICATION INFORMATION FORMAT FOR THE RELEASE OF GENETICALLY MODIFIED HIGHER PLANTS

According to Council Decision 2002/813/EC

A.                           General information

1.         Details of notification

(a)   Notification number                                        B/IE/06/01               

(b)   Date of acknowledgement of notification    16^th January 2006

(c)    Title of the project

Notification for the release into the environment of genetically modified potatoes with improved resistance to Phytophthora infestans (2006 – 2010)

(d)   Proposed period of release                            

From 01/04/2006 until 31/10/2010

2.         Notifier

Name of institute or company:         

BASF Plant Science GmbH
Carl-Bosch-Straße 38
D-67056 Ludwigshafen

3.         Is the same GMPt release planned elsewhere, inside or outside the Community [in conformity with Article 6(1)] by the same notifier?

Yes      (x)                    No       (.)

If yes, insert the country code(s): SE, NL, DE  

Please use the following country codes:

Austria AT; Belgium BE; Germany DE; Denmark DK; Spain ES; Finland FI; France FR; United Kingdom GB; Greece GR; Ireland IE; Iceland IS; Italy IT; Luxembourg LU; Netherlands NL; Norway NO; Portugal PT; Sweden SE 

4.         Has the same GMPt been notified for release elsewhere, inside or outside the Community, by the same notifier?

Yes      (x)                    No       ()

If yes, notification number(s): B/NL/05/03, B/SE/05/8615, B/DE/05/174

B.      Information of the genetically modified plant

1.         Identity of the recipient or parental plant

(a)                Familiy name                                        Solanacea

(b)               Genus                                                   Solanum

(c)                Species                                                tuberosum L.

(d)               Subspecies (if applicable)                      tuberosum

(e)                Cultivar/breeding line (if applicable)      

(f)                 Common name                         Potato

2.         Description of the traits and characteristics, which have been introduced or modified, including marker genes and previous modifications

-     improved resistance to Phytophthora infestans

-         Ahas gene (tolerance to Imidazolinones) as selectable marker gene to identify transgenic cells in tissue culture
 

3.         Type of the genetic modification

(a)    Insertion of genetic material                (x)

(b)   Deletion of genetic material                (.)

(c)    Base substitution                                (.)

(d)   Cell fusion                                         (.)

(e)    Other, specify                                    …

4.         In the case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted

-         T-DNA borders, pTiT37, for incorporation into plant chromosome

-         ahas gene, A. thaliana, imidazolinone tolerance in plant material

-         Promoter and terminator from nopaline synthase gene, A. tumefaciens, gene regulation

-         Resistance genes Rpi-blb1 and Rpi-blb2, Solanum bulbocastanum, with endogenous promoters and terminators for improved resistance to P. infestans

5.         In the case of deletion or other modification of genetic material, give information on the function of the deleted or modified sequences

Not applicable.

6.         Brief description of the method used for the genetic modification

Plasmid DNA was introduced into the potato lines by Agrobacterium-mediated gene transfer technology. This is standard technology for potato transformation.

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.

C.      Information relating to the experimental release

1.         Purpose of the release (including any relevant information available at this stage) such as agronomic purposes, test of hybridisation, changed survivability or dissemination, test of effects on target or non-target organisms

The purpose of the release is, within the frame of safety studies to compile data on agronomical performance and environmental effects, as well as to evaluate resistance against Phytophthora infestans, collect plant material for further analyses, as well as to generate seed tubers.

2.         Geographical location of the release site

The release site will be located in Co. Meath.

3.         Size of the site (m²)

Approx. 1 ha

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

There have been no previous releases of the same potato plants. For other potato lines with ahas gene in previous field trials in Germany and other EU countries since 2002 or with an introduced Rpi-blb2 gene during 2005 in Sweden no adverse impacts on the environment or human health have been recorded.

D.      Summary of the potential environmental impact of the release of the GMPts in accordance with Annex II, D2 to Directive 2001/18/EC

The genetically modified potato lines contain two NBS-LRR-genes, Rpi-blb1 and Rpi-blb2, from S. bulbocastanum for conferring improved resistance to P. infestans. Many conventional potato varieties also contain NBS-LRR-genes that have been introgressed from wild Solanum species. An intended effect of the introduced trait is an increased survivability in potato fields exposed to P. infestans. This possible selective advantage, however, is of importance only in the agricultural field, and will not improve the survivability in the surrounding environment. The reduced need for fungicides on these lines can easily be identified as an environmental benefit.

The ahas gene expressed in the potato plants imparts tolerance to the herbicidal active substance Imazamox to the shoots during the selection process in cell culture. This confers no selective advantage in the field since Imidazolinone herbicides are not approved for use on crops in Ireland and since no field tolerance is expected in the potato plants. No difference with respect to persistence in agriculturally utilised habitats or invasiveness into natural habitats as compared to conventional potato varieties is expected. Through the measures which are taken during the release, distance from or absence of conventionally cultivated potatoes or wild species, the possibility of any gene transfer can be virtually ruled out. Even in the very improbable event that pollen were to be transferred to genetically unmodified potato plants, no consequences are to be expected, since potato propagation conventionally takes place via tubers and not via seeds. The interactions of the genetically modified potato line with non-target organisms and the effects resulting from this will be comparable to those with conventional potato varieties. Furthermore, no toxic or allergenic effects are expected on the basis of the improved resistance to P. infestans or the expressed AHAS protein. No effects on biogeochemical processes are expected, other than those that apply also to conventional potatoes.

E.      Brief description of any measures taken by the notifier for the control of risks including isolation designed to limit dispersal, for example for monitoring and post-harvest monitoring proposals

An isolation distance of 20 m to other potato varieties will be observed. Planting and harvesting equipment will be cleaned on site to prevent the dispersal of GM tubers. There will be no potato cultivation on the release area the year following the release. Potential volunteers will be monitored and removed according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.

F.      Summary of planned field trials designed to gain new data on the environment and human health impact of the release (where appropriate)

            Not applicable.

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