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Risk Assessment generated by a regulatory process
(RA)
|
published: 28 Feb 2005
last updated: 25 Sep 2012
Application for the release into the environment of potatoes with altered starch composition (I) according to the Genetically Modified Organisms Decree
EN
07 Apr 2004
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Competent National Authority:Ministry of Infrastructure and Watermanagement ()Rijnstraat 8 2515 XPThe Hague, South Holland
P.O.Box 20901, Netherlands (Kingdom of the)Phone: +316 21463694,Fax:Email: terrens.saaki@minienw.nl,
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Potato with altered starch composition| BASF Plant Science GmbH | Changes in quality and/or metabolite content (Amylose and amylopectin ratio, Carbohydrates), Resistance to antibiotics (Kanamycin)
- SNIF B/NL/05/04 [ English ]
- SNIF B/NL/03/11 [ English ]
EN
The trial will be confined by a 20 meter isolation distance. Outcrossing to neighbouring fields is therefore highly unlikely.
EN
EN
The risk on any adverse effect is considered to be negligible.
EN
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 for 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.
EN
Although not expected, based on the data supplied it cannot be ruled out that the amylopectine-free tubers will display an altered frost tolerance compared to the parental organism. Therefore restriction of outcrossing by applying a 20 meter isolation distance is mandatory to confine any effect to the experimental plot.
EN
The field trial will be conducted in the northeast part of the Netherlands. Under these conditions potato is biologically contained.
In this region commercial cultivation of (starch) potatoes occurs also.
EN
In this region commercial cultivation of (starch) potatoes occurs also.
No specific validated detection methos available.
EN
The genetically modified potato line shows a shift of the tuber starch composition to amylose. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM line via the introduced traits. Due to the measures to be taken during the release (distance to or absence of cultivated and wild relatives) will the potential for gene transfer virtually excluded. Interactions of the GM potato line with non-target species and resulting effects will be comparable to those of conventional potato varieties. No toxic or allergenic effects are expected from elevated levels of amylose starch, nor from the neomycin phosphotransferase. Measures in place under current field trial practice will protect the trial from damage by animals as well as safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of to minimize or prevent contact to humans or animals. No effects are expected on biogeochemical processes. The GM potato lines will be cultivated under conventional agricultural practices.
The purpose of the release is, within the frame of safety studies for event AM99-2003, to compile data on agronomical performance and environmental effects, as well as to collect plant material for further analyses (e.g. biochemistry, molecular biology). It is anticipated that in part the trial will be used as well to generate seed tubers.
An English version of the notifications including the risk assessment is available at the EU WebSNIF website EC-JRC GMO Register under notifications number B/NL/03/11 and B/NL/05/04.
The consents are available at http://www.ggo-vergunningverlening-zoeken.nl (notification numbers IM 03-011 and IM 05-004) (only in Dutch).
EN
The purpose of the release is, within the frame of safety studies for event AM99-2003, to compile data on agronomical performance and environmental effects, as well as to collect plant material for further analyses (e.g. biochemistry, molecular biology). It is anticipated that in part the trial will be used as well to generate seed tubers.
An English version of the notifications including the risk assessment is available at the EU WebSNIF website EC-JRC GMO Register under notifications number B/NL/03/11 and B/NL/05/04.
The consents are available at http://www.ggo-vergunningverlening-zoeken.nl (notification numbers IM 03-011 and IM 05-004) (only in Dutch).
- Dutch National GMO Register (in Dutch) [ English ]
- EC-JRC GMO Register [ English ]