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Risk Assessment generated by a regulatory process
(RA)
published: 03 Jun 2010
last updated: 11 Jun 2020
6786-01-0159 (adv. 42010.0159); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum) transformed with plasmids pBinAR-StSDD1 and pBinARHyg-AtSDD1, issued by the German Competent Authority
EN
01 Apr 2005
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Competent National Authority:Federal Office of Consumer Protection and Food Safety (BVL) ()Department Genetic Engineering and other Biotechnological Processes, Gerichtstr. 49Berlin,
13347, GermanyPhone: +49-(0)3018 444-40500,Fax:Email: german_bch@bvl.bund.de,
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Potato modified for increased stomata density| Max Planck Institute of Molecular Plant Physiology(MPIMP) | Resistance to antibiotics (Kanamycin, Neomycin), Tolerance to abiotic stress (Drought)
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Potato modified for decreased Stomata Density| Resistance to antibiotics (Hygromycin), Tolerance to abiotic stress (Drought)
- 6786-01-0159 (adv. 42010.0159); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum) transformed with plasmids pBinAR-StSDD1 and pBinARHyg-AtSDD1, issued by the German Competent Authority (courtesy translation; only the German text is authentic) [ English ]
- 6786-01-0159 (bzw. 42010.0159); Zusammenfassung der Risikobewertung eines Freisetzungsvorhabens (Feldversuch) mit gentechnisch veränderten Kartoffeln (Solanum tuberosum) transformiert mit den Plasmiden pBinAR-StSDD1 und pBinARHyg-AtSDD1, erstellt durch die deutsche zuständige Behörde [ German ]
The execution of this field trial is not expected to have a negative impact on human or animal health, or on the environment.
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Adverse effects on human or animal health or on the environment are not expected.
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1 field site in Germany, details see German LMO/GMO location register (German language only) (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
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PCR-based method, construct-specific
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In these genetically modified potatoes the guard cell density is altered. This influences the gas exchange and water consumption of the plants and hence their growth under given weather conditions.
The modified potato plants were selected using the nptII-gene product NPT or the hph-gene product hygromycin phosphotransferase. Hence the plants must be considered to be resistant against antibiotics like neomycin, kanamycin or hygromycin.
The genetically modified potatoes harvested in the field trials are not intended for use in the production of foodstuffs or animal feed. Within the scope of the proposed release the alteration of the gas exchange and/or water consumption of the genetically modified potato plants is not expected to pose any threat to human or animal health, or to the environment. No new proteins will be generated in the plant as a consequence of the genetic modification.
In Europe the establishment of potatoes in natural ecosystems has not been observed, since potatoes compete poorly against wild plants and they are not frost resistant. From time to time potato plants are found beyond the cultivated areas, but only on non-natural sites such as verges and other ruderal areas. Owing to the lack of frost hardiness the cultivated potato does not establish in these areas either.
Potato plants can blossom and bear fruit. However, under Central European climate conditions there is little likelihood that potato seeds will overwinter and produce plants.
Attempts to cross-breed potatoes with solanaceous plants found in Central Europe were not successful. In agricultural practice, potatoes are propagated vegetatively via tubers. The pollen of the potato plant can be transferred by insects or by wind. However, wind dispersal only takes place over short distances. Pollen transfer, therefore, would have no effect on the results of cultivation.
The mode of action of the inserted genes and of its products is not expected to have a negative impact on human or animal health, or on the environment.
Provisions to be adopted during the course of and after finishing the field trial will limit the possibility of interaction with other plant species and crops.
The genetically modified potatoes referred to in the proposed field trial are not intended for use in foodstuffs or animal feed.
The field trial aims at validating the expected effect of the genetic modificaion under field conditions.
Field trial, not for human consumption or for feed purposes
An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/DE/04/159 (see below)
EN
The modified potato plants were selected using the nptII-gene product NPT or the hph-gene product hygromycin phosphotransferase. Hence the plants must be considered to be resistant against antibiotics like neomycin, kanamycin or hygromycin.
The genetically modified potatoes harvested in the field trials are not intended for use in the production of foodstuffs or animal feed. Within the scope of the proposed release the alteration of the gas exchange and/or water consumption of the genetically modified potato plants is not expected to pose any threat to human or animal health, or to the environment. No new proteins will be generated in the plant as a consequence of the genetic modification.
In Europe the establishment of potatoes in natural ecosystems has not been observed, since potatoes compete poorly against wild plants and they are not frost resistant. From time to time potato plants are found beyond the cultivated areas, but only on non-natural sites such as verges and other ruderal areas. Owing to the lack of frost hardiness the cultivated potato does not establish in these areas either.
Potato plants can blossom and bear fruit. However, under Central European climate conditions there is little likelihood that potato seeds will overwinter and produce plants.
Attempts to cross-breed potatoes with solanaceous plants found in Central Europe were not successful. In agricultural practice, potatoes are propagated vegetatively via tubers. The pollen of the potato plant can be transferred by insects or by wind. However, wind dispersal only takes place over short distances. Pollen transfer, therefore, would have no effect on the results of cultivation.
The mode of action of the inserted genes and of its products is not expected to have a negative impact on human or animal health, or on the environment.
Provisions to be adopted during the course of and after finishing the field trial will limit the possibility of interaction with other plant species and crops.
The genetically modified potatoes referred to in the proposed field trial are not intended for use in foodstuffs or animal feed.
The field trial aims at validating the expected effect of the genetic modificaion under field conditions.
Field trial, not for human consumption or for feed purposes
An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/DE/04/159 (see below)
- Summary Notification Information Format available on the Internet (WebSNIF) [ English ]
- Summary Notification Information Format erhältlich im Internet (WebSNIF) (nur in englischer Sprache) [ German ]
- BVL database on field trials in Germany (German language only) [ English ]
- BVL-Datenbank zu Freisetzungsvorhaben in Deutschland [ German ]
- BVL German LMO/GMO location register [ English ]
- Deutsches GVO-Standortregister des BVL [ German ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |