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Notification report


General information

Notification Number
B/GB/03/R29/4

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
13/02/2003

Title of the Project
Analysis of the expression of a TI1-GUS transgene in peas, grown with or without drought-treatment, in a semi-realistic 'field' environment and production of leaf and seed material for metabolite profiling and biochemical analyses

Proposed period of release:
01/04/2003 to 30/09/2004

Name of the Institute(s) or Company(ies)
John Innes Centre, ;


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 sativumcv.Puget

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The modified pea lines (4) each contain a GUS (uidA) reporter gene fused to the drought-responsive promoter of a pea trypsin inhibitor gene, TI1. The plants also contain a selectable marker gene (bar) that confers resistance against the herbicides containing phosphinothricin/glufosinate as active ingredients.

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:
Abbreviation: RB
Definition: Right border
Source: synthetic
Size: (bp)25
Accession no. or reference: www.pgreen.ac.uk
Function: T-DNA integration

Abbreviation: TI1
Definition: Promoter sequence
Source: Pisum sativum (pea)
Size: (bp)1013
Accession no. or reference: AJ276900
Function: Expression of GUS gene

Abbreviation: GUS
Definition: UidA gene
Source: E. coli
Size: (bp)1800
Accession no. or reference: Guerineau and Mullineaux, 19931
Function: Glucuronidase enzyme production

Abbreviation: Term
Definition: Transcription terminator
Source: CaMV
Size: (bp)750
Accession no. or reference: Guerineau and Mullineaux, 19931
Function: Terminate transcription

Abbreviation: 35S
Definition: 35S CaMV promoter
Source: CaMV
Size: (bp)400
Accession no. or reference: Guerineau and Mullineaux, 19931
Function: Expression of bar gene

Abbreviation: bar
Definition: Herbicide tolerance gene
Source: Streptomyces hygroscopicus
Size: (bp)600
Accession no. or reference: De Block et al., 19872
Function: Resistance to glufosinate ammonium herbicides

Abbreviation: Term
Definition: Transcription terminator
Source: CaMV
Size: (bp)750
Accession no. or reference: Guerineau and Mullineaux, 19931
Function: Terminate transcription

Abbreviation: LB
Definition: Left border
Source: synthetic
Size: (bp)25
Accession no. or reference: www.pgreen.ac.uk
Function: T-DNA integration

Abbreviation: ColE1
Definition: Replication
Source: E. coli
Size: (bp)379
Accession no. or reference: V00268
Function: Replication functions in E. coli

Abbreviation: OriT
Definition: Origin for conjugation
Source: E. coli
Size: (bp)99
Accession no. or reference: X14165
Function: Plasmid transfer between bacteria

Abbreviation: oriV
Definition: Origin of replication
Source: E. coli
Size (bp)618
Accession no. or reference: M20134 and U09365
Function: Replication functions in E. coli and Agrobacterium

Abbreviation: nptIII
Definition: Kanamycin resistance gene
Source: E. coli
Size: (bp)795
Accession no. or reference: V01547 and U09365
Function: Selection of bacteria

Abbreviation: trfA
Definition: Replication gene
Source: E. coli
Size: (bp)1482
Accession no. or reference: X00713 and U09365
Function: Replication in E.coli


6. Brief description of the method used for the genetic modification:
The Ti plasmid vector, pRS:GIT, harbouring the GUS fusion and bar gene, was transformed into pea axilllary meristems in culture using Agrobacterium-mediated procedure.

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:
A two-year programme to test the effect of drought on the expression of an introduced reporter gene and to provide transformed leaf and seed material from plants grown under variable environmental conditions for metabolite profiling and other biochemical analyses.

2. Geographical location of the site:
Colney/ Norwich; Norfolk.

3. Size of the site (m2):
Two raised beds, each of 1m x 2m (2m2) in a polytunnel of 600m2

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:
not applicable

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Due to the measures employed during and following the trial and the scale and nature of the release, it will not have a significant impact on the environment (see E below). The plants (256) are to be grown in a polytunnel in the middle of a research site and research park,

Brief description of any measures taken for the management of risks:
· Plants will be staked and seeds will be harvested by hand.
· No specific measures will be taken to prevent pollen dispersal since pea is primarily self-pollinating (0.07% outcrossing at 6.3 metres; see Q.35a).
· At the end of the first year's experiment, the beds will be left to overwinter before sowing in the second year. At the end of the second year, the beds will be dismantled and the soil will be steam-sterilized.
· All waste plant material, including roots, will be removed and autoclaved. The non-transgenic guard plants will also be removed and autoclaved.
· The polytunnel and growth beds will be monitored daily by scientific staff. This will include overall visual checks on the integrity of the site as well as specific monitoring of the plants for pest control, insect and fungal attack, or ingress of small mammals and other fauna.
· In the event of an emergency, as defined by an uncontrollable breakdown in any of the husbandry procedures all plants (whether surviving or not) in the tunnel will be dug up and autoclaved (transgenic and non-transgenic) and the plots covered with matting (in year 1) or the soil steam treated (year 2.
· The polytunnel exists within the JIC, which is fenced and patrolled by security staff. The site and plants will be monitored daily, including weekends, as part of the routine husbandry of experimental material.


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
21/05/2003 00:00:00
Remarks:
Consent granted to John Innes Centre to release GM peas on 21 May 2003 with the following limitations and conditions.

Condition 1.
John Innes Centre submitted application reference 03/R29/4, dated 13th February 2003 and further information in the applicant’s letters dated 30th March 2003 and 30th April 2003.

Condition 2.
The release authorised is in accordance with the limitations and conditions set out in Annex 1 to this Schedule (the application), 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 either one month after the date of termination of each release in the programme of work or by 31 October 2003, whichever is the sooner, and each year thereafter until 31 October 2004