Germany | BCH-DEC-DE-48372 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-48372-9   |   PDF   |   Print   |  
published: 06 Mar 2009 last updated: 15 Jun 2020
Amendment
No
General Information
6786-01-0191 (adv. 42010.0191); Decision regarding the deliberate release (field trial) of genetically modified potato (Solanum tuberosum) lines pAP4, VCPMA16, and VCPMA19, issued by the German Competent Authority
EN
31 Mar 2008
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
- Fertile plant material (potato tuber) has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory and has to kept separately from non transgenic potatoes. The label need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption (food and feed). All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
- Inspection of release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and if required sufficient risk measures have to be performed.
- During and after the field trial monthly inspection of the surrounding area [10 m] of the release site for transgenic potato volunteers and their manual removal and disposal has to be accomplished.
- All transgenic potatoes that are not intended to be used for further cultivation or analysis as well as transgenic potatoes that are found when cleaning the working equipment have to be disposed by disruption of their germination capacity.
- After harvest and in the following spring the first 20 cm of the soil of the release site has to be loosen up and uncovered potatoes as well as potatoes that are found on the working equipment have to be collected and disposed by disruption of their germination capacity. The release site must not be ploughed.
- After completion of the field trial an inspection of the release site for one year on transgenic potato volunteers, their removal and disposal has to be accomplished during the growing season every 4 weeks. If experimental release involved overwinter survival trials inspection of the release site has to be performed from May to December after harvest. The inspection period has to be extended for another year if potato volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers.
- A sign indicating "Versuch mit gentechnisch veränderten Kartoffeln, die nicht als Lebensmittel oder Futtermittel zugelassen sind. Eine Entnahme durch Unbefugte ist nicht gestattet." (test with genetically modified potatoes, not authorized for use as food and feed, unauthorized removal is not permitted) has to be put up at the release site.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-48075-7 Living Modified Organism BPS-A1Ø2Ø-5 - Amadea potato
    BASF Plant Science GmbH | Changes in quality and/or metabolite content (Amylose and amylopectin ratio), Resistance to herbicides (Imidazolinone, Sulfonylurea), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-48361-4 Living Modified Organism Potato modified for resistance to Phytophthora infestans
    BASF Plant Science GmbH | Resistance to diseases and pests (Phytophthora infestans resistance), Resistance to herbicides (Sulfonylurea)
  • BCH-LMO-SCBD-48362-8 Living Modified Organism BPS-PHØ48-1 - Fortuna potato
    BASF Plant Science GmbH | Resistance to antibiotics (Streptomycin), Resistance to diseases and pests (Fungi), Resistance to herbicides (Imidazolinone, Sulfonylurea)
  • BCH-RA-DE-48127-7 Risk Assessment generated by a regulatory process 6786-01-0191 (adv. 42010.0191); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum) lines pAP4, VCPMA16, and VCPMA19, issued by the German Competent Authority
    BPS-A1Ø2Ø-5 - Amadea potato | Potato, SOLTU, Resistance to herbicides, Changes in quality and/or metabolite content, Selectable marker genes and reporter genes | Potato modified for resistance to Phytophthora infestans | Potato, SOLTU, Resistance to diseases and pests, Resistance to herbicides | BPS-PHØ48-1 - Fortuna potato | Potato, SOLTU, Resistance to diseases and pests, Resistance to herbicides, Resistance to antibiotics
Document on the decision, communication, notification or declaration
Additional Information
type of decision: field trial
LMO: pAP4 (3 lines), VCPMA16 (257 lines) and VCPMA19 (278 lines)
legal basis: Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act]
scope: test of field performance of LMO, screening of suitable lines
authorization valid from 31 March 2008 to 31 December 2012
locations: experimental fields located in 3 different villages in Germany; for details see German LMO/GMO location register (http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
size: 1 ha/site/year
app. 45.000 LMO/site/year
EN