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Notification report


General information

Notification Number
B/GB/02/R04/12

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
13/12/2002

Title of the Project
Consent application to release potatoes genetically modified in carbohydrate metabolism

Proposed period of release:
01/03/2003 to 30/11/2003

Name of the Institute(s) or Company(ies)
Advanced Technologies (Cambridge) Ltd, 210 Cambridge Science Park
UK-Cambridge CB4 0WA;


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
potatosolanaceaesolanumsolanum tuberosumtuberosumHermes and Prairie

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The introduced traits are altered sugar and starch content. In addition the marker gene NPTII has been used to provide transgenic plants. Similar transgenic potatoes produced by the same methods were released under consent 96/R4/6, 01/R4/10.

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:
Genetic elements common to the T-DNA region of all constructs which is transferred to the plant

Definition: Right border sequence, Source: Agrobacterium, Function: T-DNA integration.
Definition: Nopaline synthase Promoter, Source: Agrobacterium, Function: Constitutive promoter.
Definition: Kanamycin resistance coding sequence, Source: E.coli, Function:
Selectable marker for transformed plants.
Definition: Part of enzyme coding sequence, Source: Agrobacterium, Function:
None.
Definition: Nopaline synthase terminator signal, Source: Agrobacterium, Function: Transcription stop signal.
Definition: Part of coding sequence for Bacteriophage M13 coat protein, Source: Bacteriophage M13, Function: None.
Definition: Part of LacI repressor sequence, Source: E. coli, Function: Colour selection during cloning.
Definition: B-galactosidase, Source: E. coli, Function: Selection during cloning.
Definition: Incomplete origin of replication, Source: Bacteriophage M13, Function: None.
Definition: Part of LacI repressor, Source: E. coli, Function: None.

Specific elements in each construct
Construct 1.
Definition: Patatin promoter pS3-27, Source: Solanum tuberosum, Function: Tuber specific expression.
Definition: Antisense Acid Invertase coding sequence, Source: Solanum tuberosum, Function: Decrease invertase enzyme activity.
Definition: Nopaline synthase terminator signal , Source: Agrobacterium, Function: Transcription stop signal.


Construct 2
Definition: Patatin promoter pS3-27, Source: Solanum tuberosum, Function: Tuber specific expression.
Definition: Partial sense FtsZ type 2 coding sequence, Source: Solanum tuberosum, Function: Decrease production of coding FtsZ type 2 protein.
Definition: Nopaline synthase terminator signal, Source: Agrobacterium, Function: Transcription stop signal.

Construct 3
Definition: Patatin promoter pS3-27, Source: Solanum tuberosum, Function: Tuber specific expression.
Definition: Antisense FtsZ type 1 coding sequence, Source: Solanum tuberosum, Function: Decrease production of coding FtsZ type 1 protein.
Definition: Nopaline synthase terminator signal, Source: Agrobacterium, Function: Transcription stop signal.

Construct 4
Definition: Patatin promoter pS3-27, Source: Solanum tuberosum, Function: Tuber specific expression.
Definition: Partial sense FtsZ type 1 coding sequence, Source: Solanum tuberosum, Function: Decrease production of coding FtsZ type 1 protein.
Definition: Nopaline synthase terminator signal, Source: Agrobacterium, Function: Transcription stop signal.


6. Brief description of the method used for the genetic modification:
Leaf disc transformation with Agrobacterium tumefaciens. Transformants were selected on kanamycin.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Solanum tuberosum is not a forest tree species.

Experimental Release

1. Purpose of the release:
To examine the effect of the modification of carbohydrate metabolism on the quality of potato tubers.

2. Geographical location of the site:
Scott Abbott Arable Crops Station, Sacrewell Lodge Farm, Thornhaugh, Peterborough, UK OS reference TF072014.

3. Size of the site (m2):
Less than 2000m2.

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:
Similar potato plants were released under Consent Ref. 96/R4/6. Some of the same potato plant lines were released under Consent Ref. 01/R4/10. Monitoring reports have been submitted on these releases concluding that there has been no environmental or human health impacts.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
1. Direct Effects

(i)Impacts on receiving agricultural system
None. Changes in carbohydrate levels are within range found in potato cultivars. ARM (NPTII) is from bacteria which are widespread in the environment and has no impact on the agricultural system. Vector backbone sequences will not produce functional products in potato.

(ii)Impacts on non-target environments
None. Potato is not persistent outside of normal agricultural practice. Release is spatially separated from non-target environments.

(iii)Impacts on human health
None. Plants are not for human consumption.


2. Indirect Effects

(i)Impacts on receiving agricultural system
None. Normal agronomic practice for potato will be observed. The GM plants will have no greater impact on the biotic and abiotic environment compared to non-GM plants.

(ii)Impacts on non-target environments
None. Potato is not persistent outside of normal agricultural practice. Release is spatially separated from non-target environments.

(iii)Impacts on human health
None.Plants are not for human consumption.


3. Spatial properties of the release

(i)Impacts on receiving agricultural system
Area of release will be no greater than 2000 m2.

(ii)Impacts on non-target environments
None. Potato is not persistent outside of normal agricultural practice. Release is spatially separated from non-target environments.

(iii)Impacts on human health
No likelihood of increase of impact on human health. Release is spatially separated from residences and places of work.


4. Temporal extent of the release

(i)Impacts on receiving agricultural system
March-November 2003. Volunteers may persist beyond the release, but will be controlled by monitoring and normal agricultural practice.

(ii)Impacts on non-target environments
None.Potato is not persistent outside of normal agricultural practice. Release is spatially separated from non-target environments.

(iii)Impacts on human health
None.


5. Severity of effects

(i)Impacts on receiving agricultural system
None. The GM plants will have no greater impact than non-GM plants.

(ii)Impacts on non-target environments
None. The GM plants will have no greater impact than non-GM plants.

(iii)Impacts on human health
None. The GM plants will have no greater impact than non-GM plants.


6. Latency and cumulative effects

(i)Impacts on receiving agricultural system
None expected. Volunteers may persist beyond the release, but will be controlled by monitoring and normal agricultural practice.

(ii)Impacts on non-target environments
None expected. Volunteers may persist beyond the release, but will be controlled by monitoring and normal agricultural practice.

(iii)Impacts on human health
None.


7. Reversibility of effects

(i)Impacts on receiving agricultural system
Any impact is reversible by removal of the plants, controlled by monitoring and normal agricultural practice.

(ii)Impacts on non-target environments
Any impact is reversible by removal of the plants.

(iii)Impacts on human health
Not applicable. Plants are not for human consumption. Trial is limited to the release period.


Brief description of any measures taken for the management of risks:
Plants will be planted with a designed surround of non-genetically modified potato plants and a 3m wide uncultivated zone. There will be a minimum of 20m between the potatoes planted in the trial and any other potato crop.
The release will be monitored at least once a month. Destruction of the genetically modified plants with an approved herbicide or physical removal will be carried out if problems arise.
The site will be inspected in the following two years (2004 and 2005) for volunteers and any volunteers surviving normal agronomic practice will be destroyed.


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 Member State Competent Authority:
Yes
24/03/2003 00:00:00
Remarks:
ConsentRemark
"Consent granted to Advanced Technologies (Cambridge) Ltd, to release GM potatoes, on 18 March 2003 with the following limitations and conditions.

Condition 1
Advanced Technologies (Cambridge) Limited submitted application reference 02/R4/12, dated 13 December 2002 and further information in the applicant’s letters dated 11 February 2003 and 21 February 2003.

Condition 2
The release authorised is in accordance with the limitations and conditions set out in Annex 1 (the application) to this Schedule, those set out in condition 3 below and the conditions which are implied in the consent by virtue of section 112 of the Environmental Protection Act 1990.

Condition 3. The holder of the consent shall notify the following information to the Secretary of State at the times specified:
a. The general condition specified in section 112(5)(b) of the Environmental Protection Act 1990, as substituted by Regulation 29 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (the 2002 Regulations), shall have effect subject to the specific condition that the consent holder shall submit a report on the effects of the release authorised by the consent for the assessment of any risks there are of damage to the environment from the genetically modified organism concerned:
(i) by one month after the date of termination of the release or by 31 December 2003 whichever is the sooner and;
(ii) annually on the anniversary of the date of the termination of the release or by 30 November whichever is the sooner to cover post-trial monitoring for the assessment of the effectiveness of measures to control volunteers and the re-evaluation of the post trial monitoring requirements until a period of two years when no volunteers are observed."