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Notification report


General information

Notification Number
B/GB/03/R38/1

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
08/07/2003

Title of the Project
Consent application for a 3 year programme of work to release winter oilseed rape genetically modified for pollen infertility, fertility restoration and herbicide tolerance

Proposed period of release:
08/09/2003 to 30/09/2006

Name of the Institute(s) or Company(ies)
Bayer CropScience Ltd., Hauxton, Cambridge CB2 5HU;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/BE/00/VWSP10; B/BE/00/VWSP9; B/BE/94/VSP1; B/BE/94/W2; B/BE/95/VSP6; B/DE/98/90; B/DK/98/04; B/ES/97/41; B/FR/00/07/03; B/FR/95/05/10; B/FR/96/01/14; B/FR/96/07/04; B/FR/97/01/10; B/FR/97/08/06; B/FR/97/08/07; B/FR/99/01/15; B/FR/99/06/04; B/FR/99/06/05; B/GB/00/R33/1; B/GB/00/R33/5; B/GB/00/R33/5S; B/GB/00/R33/6; B/GB/00/R33/6S; B/GB/00/R33/7; B/GB/00/R33/7S; B/GB/00/R33/9; B/GB/01/R33/10; B/GB/01/R33/10S; B/GB/01/R33/11; B/GB/01/R33/11S; B/GB/95/R15/7; B/GB/95/R15/8; B/GB/96/R15/16; B/GB/96/R15/17; B/GB/97/R15/18; B/GB/97/R15/19; B/GB/97/R15/20; B/GB/97/R15/21; B/GB/97/R15/22; B/GB/98/R19/18; B/SE/95/120; B/SE/96/58; B/SE/96/726; B/SE/97/4291; B/SE/98/1825; B/SE/99/1911; B/SE/99/2769;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
oilseed rapebrassicaceaebrassicabrassica napusnapus (syn. oleifera)

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The recipient organism is a commercial spring variety of oilseed rape commonly cultivated in Europe, which has been genetically modified to introduce a pollination control system (hybrid system), linked to a herbicide tolerant trait.

Pollination control:
Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. The SeedLink® hybridisation system allows that the female plants are pollinated by the desired male plants. It is based on:
- A female line obtained by the unique combination of a natural catabolic activity, a ribonuclease (Barnase protein produced by the barnase gene), and a DNA sequence limiting its expression to a specific stage and time during the development of the anthers. This female line does not produce pollen and thereby prevents self-pollination and enables the production of hybrids.
- A fertility restoration line (male line) harbouring a highly specific inhibitor (Barstar protein produced by the barstar gene) of the introduced ribonuclease (Barnase protein). Full fertility restoration is obtained after a cross between the female line and the fertility restoration line. Fertility restoration ensures that the hybrid seed is itself fully fertile in the farmer's field.

The resulting hybrid oilseed rape varieties have higher yields than conventional varieties, while their consistent growth and even ripening make harvesting easier.

Herbicide tolerance:
The SeedLink® hybridisation system is combined with the LibertyLink® trait of tolerance to Liberty® herbicide (active ingredient glufosinate-ammonium), through the PAT protein (produced by the bar gene) that degrades the herbicide. Liberty® enables farmers to use a broad spectrum herbicide with positive environmental characteristics and to avoid the precautionary pre-emergence herbicide treatments: it allows for postponing weed control operations and herbicide applications until really necessary, contributing an important tool in Integrated Crop Management. Farmers are thus given the flexibility to tolerate flora and fauna in their fields that do not pose a threat to either the quality or the yield of their crop.


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:
Male sterile transformation event Ms8:
pTHW107
a) PSsuAra-bar-3'g7: This sequence contains the promoter PSsuAra regulating the expression of the bar gene coding for phosphinothricin acetyl transferase and the 3'end of the T-DNA gene 7.
b) PTA29-barnase-3'nos: The promoter PTA29 regulates the expression of the male sterility gene (barnase). This sequence contains also the 3'end of the nopaline-synthase-gene.

Fertility restorer transformation event Rf3:
pTHW118
1. PSsuAra-bar-3'g7: This sequence contains the promotor PSsuAra, regulating the expression of the bar-gene coding for phosphinothricin acetyl transferase and the 3'end of the T-DNA gene 7.
2. PTA29-barstar-3'nos: The promotor PTA29 regulates the expression of the barstar-gene conferring fertility restoration. The sequence contains also the 3'end of the nopaline-synthase-gene.


6. Brief description of the method used for the genetic modification:
Insertion of genetic material by (Agrobacterium tumefaciens mediated) 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

Experimental Release

1. Purpose of the release:
The releases covers all the work necessary for variety registration conducted on behalf of DEFRA, Plant Variety Rights Office and Seeds Division and may include National List (NL), Plant Breeders’ Rights (PBR), Provisional Seed Certification (PSC) and also Recommended list (RL) trials conducted by and/or on behalf of NIAB. This work is as defined in the DEFRA protocols for NL/PBR tests and trials and seed certification and in the NIAB protocol(s) for RL trials.

2. Geographical location of the site:
Hutton Fields, Hutton Magna, Richmond, N. Yorks DL11 7HG4-figure grid reference: NZ 13 12 (First Simplified Procedure application)

3. Size of the site (m2):
500m2

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:
Bayer has conducted more than 50 trials in 8 countries to evaluate the hybrid system of M38xRf3 genetically modified oilseed rape.

Field trials with transgenic nuclear male sterile plants have been executed since 1989 (tobacco). In 1990, NMS-oilseed rape was introduced in field trials in Belgium and France and in 1991, the NMS oilseed rape trials were extended to Canada and Sweden. In addition, applications for testing the restorer lines (RF) and/or the restoration product (NMS x RF) were granted for the first time in 1992 (Canada, France and Belgium). In 1993 various multi-site oilseed rape trials, established in several countries throughout Europe and Northern America, confirmed that a reliable hybrid system in oilseed rape obtained through genetic engineering was achieved. In 1993 a first spin-off breeding group started to incorporate the new hybrid system in a focused breeding program.

Expansion of the field testing program in 1994 and 1995: evaluation of hybrid material in different locations spread over Canada and Europe.

In 1995, Bayer received consent to market transgenic oilseed rape seeds (based on Ms1, Rf1 and Rf2) in Canada. The document (code C/UK/94/M1/1) was also submitted to the UK/European authorities. In 1995, a document (F/C/95.05.01) was submitted to the French regulatory authorities in fulfilment of the requirements for approval to place on the market transgenic oilseed rape seeds based on Rf2.

An application for consent to market (C/BE/96/01) has been submitted in Belgium in September 1996. The Belgian Competent Authority has forwarded the dossier with a favourable opinion to the European Commission.

Previous Brassica napus experiments have demonstrated that the transformed plants do not show any alteration in their morphology or growth rate.

Conclusions which we can draw from previous field experiments with the transgenic oilseed rape material are as follows :
1990 - Conformity of the system to the scientific expectations
1991 - Absence of any side effects
Stability of the nuclear male sterility and fertility restoration in different genetic backgrounds and environmental conditions
Efficiency of a selection based on a herbicide resistance marker
1992 & 1993 - Feasibility of the system in realistic agronomic and breeding perspectives
Confirmation of the results obtained in 1991 (trait stability, herbicide resistance...).
1994 to 2002 - Expansion of the field trialling program: evaluation of hybrid material in different locations spread over the world.

The following observations were made during the vegetative growth stages of these trials: germination and establishment; vigour deficiencies; leaf development.
During the flowering period the following data were gathered: flowering dates (start and end), flower morphology, sterility/fertility, plant height.
At the end of the growing season notes were taken on: lodging resistance, maturity date, disease resistance.
From planting to harvest, all plants were observed carefully in order to detect any specific differences between transgenic and control lines.
Until now, in all cases, the behaviour of the transgenic oilseed rape plants remains strictly identical to untransformed plants of the same variety. The transformed plants have a selective advantage ONLY when standing in a field treated with a herbicide containing glufosinate-ammonium.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The following conclusions were drawn (see items listed Annex II D2 of Directive 2001/18/EC):
1) The herbicide-tolerant hybrid oilseed rape neither becomes more persistent than the recipient plant in agricultural habitats, nor shows any changed behaviour with respect to invasiveness in natural habitats.
2) A selective advantage to the herbicide-tolerant hybrid oilseed rape could only be identified upon treatment with glufosinate ammonium.
3) Potential for gene transfer to oilseed rape and/or wild relatives is the same as with non-genetically modified oilseed rape: gene transfer to other oilseed rape can occur while gene transfer to wild relatives is very difficult. The same selective advantage, tolerance to treatment with glufosinate ammonium, would be conferred to those plants.
4) There are no target organisms.
5) No impact could be identified on non-target organisms such as honeybees, birds and small mammals.
6) No adverse effects on human health from contact or handling have been identified.
7) No adverse effect on animal health or the feed/food chain following animal feed use have been identified.
8) No effect or alteration on biogeochemical processes was observed.
9) Adaptations of cultivation and management techniques for the genetically modified oilseed rape are limited to changes in herbicide use, without any adverse environmental impact.

The overall conclusion is that:
- The potential adverse effect identified is establishment of transgenic herbicide tolerance, be it through herbicide-tolerant oilseed rape volunteers or through transfer of the herbicide tolerance gene to wild Brassica relatives.
- Standard Good Agricultural Practices allow adequate management of both herbicide-tolerant oilseed rape volunteers and herbicide-tolerant wild Brassica relatives i.e. allow adequate risk management of the identified adverse effects.
- The overall risk of herbicide-tolerant hybrid oilseed rape Ms8/Rf3, taking into account the risk management strategies available, is therefore nil.


Brief description of any measures taken for the management of risks:
(a) maintain the genetically modified plant at a distance from sexually compatible plant species, both wild relatives and crops.
The GM plant may be grown adjacent to other oilseed rape. No harvested rape-seed from these GM trials will be put into the human food and/or animal feed chain.No harvested rape-seed from non-GM oilseed rape grown within 50 metres of the edge of the GM oilseed rape plots will be put into the human food and/or animal feed chain. This excludes the following situations:
where a 6 metre border of non-transgenic oilseed rape surrounds the trials in such a manner that it forms an effective pollen trap (neither the GM crop nor the 6-metre border will be put into the human food and/or animal feed chain);
where the GM trial is prevented from flowering e.g. early destruction of the GM plants.

No harvested produce from sexually compatible species with which the GM rape may cross-pollinate during the release, within the 50 metres, will be put into the human food and/or animal feed chain. This excludes the following situations:
where a 6 metre border of non-transgenic oilseed rape surrounds the trials in such a manner that it forms an effective pollen trap (neither the GM crop nor the 6-metre border will be put into the human food and/or animal feed chain);
where sexually compatible species occur with which rape may only cross-pollinate under artificial conditions (e.g. cabbage);
where sexually compatible species occur that do not flower at the same time as the GM rape (e.g. turnip).

Post-release treatment of the site will be in accordance with Good Agricultural Practice. The next season the field will be brought back into normal cultivation and possible volunteers will be controlled by cultural and/or herbicide treatment in the following crop (eg for cereals: hormones, sulfonyly-ureas, diflufenican, imazamethabenz-methyl, fluroxypyr+metosulam; for sugar beet: lenacil, metamitron, desmedipham, triflusulfuron; for potatoes: linuron, terbutryn, mertibuzin, rimsulfuron).After finishing the trial the test site will monitored regularly. Any volunteer plants or sexually compatible weeds found in the area will be treated according to Good Agricultural Practice. This may exclude the following sexually compatible species:
Those with which rape may only cross-pollinate under artificial conditions (e.g. cabbage);
Those that do not flower at the same time as the volunteers (e.g. turnip).
If exceptional populations of Brassica napus are observed, i.e. more than would normally occur, the transgenic nature of these plants will be checked.


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
25/09/2003 00:00:00
Remarks:
Dear Sir

ENVIRONMENTAL PROTECTION ACT 1990, SECTIONS 111 AND 112:
CONSENT TO RELEASE GENETICALLY MODIFIED ORGANISMS

1. The Secretary of State for Environment, Food and Rural Affairs hereby grants consent to Bayer CropScience Ltd (“Bayer Crop Science”), of Hauxton, Cambridge, CB2 5HU, for the release of genetically modified organisms in accordance with the proposals set out in application 03/R38/1, dated 27 June 2003, as supplemented by further information set out in Bayer Crop Science’s letters of 17 July 2003, 24 July 2003 and 11 August 2003. This consent is subject to the limitations and conditions set out in the Schedule hereto.

2. Insofar as they relate to the protection of human health and safety, the terms and conditions of this consent have been agreed with the Health and Safety Executive. The Food Standards Agency has also been consulted in accordance with section 126(5) of the 1990 Act and the advice of the Advisory Committee on Releases to the Environment has been obtained.

3. The explanatory memorandum attached to this consent provides explanatory information on the limitations and conditions set out in the Schedule together with important information on the general conditions and other provisions to which the consent is subject, but does not form part of the consent.

4. In addition Bayer CropScience, as the consent holder, is reminded of its obligation to advise relevant farmers of the status, in terms of marketing, of MS8 x RF3 oilseed rape and the need for its adventitious presence to be minimised and in particular farmers must be aware of the requirement to comply with the forthcoming traceability and labelling regulations.

Yours faithfully
By authority of the Secretary of State for Environment, Food and Rural Affairs.


Schedule to Consent to release Genetically Modified Organisms Application Reference 03/R38/1

LIMITATIONS AND CONDITIONS

Condition 1. The release authorised is that proposed in Annex 1 to this schedule (the application) for the purposes referred to in paragraph 30 thereof and must be carried out in accordance with the limitations and conditions set out in that Annex, as modified or extended by the conditions set out in this schedule. In particular (but without limitation) the consent holder shall observe and comply with all the measures, precautions and restrictions set out or referred to in Parts V – VII (inclusive) of that Annex.

Condition 2. In addition this consent is subject to the conditions implied by virtue of section 112 of the Environmental Protection Act 1990. However, in the event of any inconsistency between those conditions and the conditions and limitations more specifically set out or referred to in this Schedule and Annex 1 hereto, the latter shall prevail. In the event of any inconsistency between any condition or limitation specifically set out in this schedule and any condition, limitation or other provision set out in Annex 1 hereto, the condition or limitation specifically set out in this schedule shall prevail.

Condition 3. The holder of the consent shall notify the following information to the Secretary of State at the times specified:

a. Pursuant to Commission Decision 94/730/EC (the “First Simplified Procedure Decision) and, in particular, paragraphs 7 and 7.2 of the Annex to that Decision, and to regulation 10 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (the “2002 Regulations”), the consent holder shall submit to the Secretary of State additional information required under the First Simplified Procedure, including the location of all the proposed release sites to a level of detail as specified by the Secretary of State, and these must be received not less than 15 days before the release on each site is intended to be carried out.

b. For sowings in 2003 the Secretary of State has specified that sites must be notified for the purposes of paragraph a of this condition to a level of detail of at least 4-figure grid reference. For the purpose of post-trial monitoring the exact location, by means of a six-figure grid reference, must be submitted to the regulatory authority once the release trial is sown.

c. Without prejudice to the need to comply with the general condition specified in section 112(5)(b) of the Environmental Protection Act 1990, as substituted by Regulation 29 of the 2002 Regulations, the consent holder shall submit reports 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 organisms concerned at the following times:

(i) in the case of Autumn sowing by the end of the thirteenth month after seed was sown in each trial and in the case of Spring sowing by the end of the eighth month after seed was sown in each trial; and

(ii) by one year after the date the first report is required to be submitted under (i) above.

The reports to be submitted under (ii) above shall cover in particular post trial monitoring for:

(1) assessment of the effectiveness of measures to control volunteers; and

(2) the re-evaluation of the post trial monitoring requirements.

In any case where a trial is terminated early, for example where the crops are destroyed following poor establishment or the removal of plant material following vandalism, a report shall be submitted not later than one month after the date of termination in addition to the reports referred to in (i) and (ii) above setting out the reasons for termination and advising on any additional precautions considered necessary to minimise any risks there are of damage to the environment or human health resulting from the release or its termination.

Condition 4. The holder of the consent shall ensure that only cereal crops are grown on the release site for the first and second cropping years after the cropping year in which the trial takes place.

Condition 5. The consent holder must ensure:

(a) that those directly involved in trials carried out under this consent at all times are aware of, understand and observe:
(i) the conditions of the consent applicable to their involvement; and
(ii) all relevant marketing, traceability and labelling requirements which are or may become applicable to material derived from the trials or to any crops (including in particular future crops of oil seed rape) subsequently grown on or in the near vicinity of the trial sites and to which herbicide tolerance GM event Ms8 x Rf3 may have transferred, and

(b) that all trial sites are managed before, during and after the trial so as to ensure that all such conditions and requirements can be observed in relation to any such material or crops as are referred to in (a) (ii).

Condition 6. The consent holder shall notify the Secretary of State when commercial in confidence information provided in the application has been published and such notification shall be given as soon as practicable after the date of publication of those details.