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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-NL-7428-10   |   PDF   |   Print   |  
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published: 28 Feb 2005 last updated: 25 Sep 2012
General Information
Application for the release into the environment of potatoes with altered starch composition (II) according to the Genetically Modified Organisms Decree
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07 Apr 2004
Risk assessment details
  • Potato with modified starch composition
    | BASF Plant Science GmbH | Changes in quality and/or metabolite content (Amylose and amylopectin ratio), Resistance to antibiotics (Kanamycin), Resistance to herbicides (Imidazolinone, Sulfonylurea)
Methodology and points to consider
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Potato has no wild relatives in Nothwest Europe, outcrossing to those relatives is therefore irrelevant. due to the combination of the climatic conditions in Northwest Europe and Good Agricultural Practices potato is biologically contained.
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The risk on any adverse effect is considered to be neglilible.
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The field trails 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.
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No specific validated detection methos available.
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Additional information
The genetically modified potato lines show a shift of the tuber starch composition to amylopectin. 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 lines 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 lines 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 amylopectin starch, nor from the neomycin phosphotransferase or acetohydroxyacid synthase. 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 events AM02-1003, AM02-1005, AM02-1012, AM02-1017 and AM99-1089 (as a comparator high amylopectin event), 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 summary of the notifications including the risk assessment is available at EU WebSNIF website EC-JRC GMO Register under notification numbers B/NL/03/10 B/NL/05/05.

The consents are available at
http://www.ggo-vergunningverlening-zoeken.nl (notification numbers IM 03-010 and IM 05-005) (only in Dutch).
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