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Risk Assessment generated by a regulatory process
(RA)
published: 27 Jun 2016
last updated: 19 Aug 2022
Transgenic canola with incorporated gene sequence, encoding chicken alpha-interferon. The conclusion of the State expertise.
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10 Jun 2016
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Competent National Authority:Ministry of Natural Resources and Environmental Protection of the Republic of Belarus ()10 Kollektornaya streetMinsk,
220048,Phone: +375 17 200-6691,Fax: +375 17 200-5583,Email: minproos@mail.belpak.by,
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Person:Associate Professor Valentina Aleksandrovna LemeshHead of the Laboratory of Genetics and Cell Engineering, Laboratory of Genetic and Cell Engineering27 Akademicheskaya streetMinsk,
220072,Phone: +375 17 284-1943,Fax: +375 17 284-1917,Email: V.Lemesh@igc.bas-net.by,Website: http://gens.by, http://gens.by,Related OrganizationInstitute of Genetics and Cytology at the National Academy of Sciences of Belarus (IGC NASB)27 Akademicheskaya streetMinsk,
220072,Phone: +375 17 284-1943,Fax: +375 17 284-1917,Email: V.Lemesh@igc.bas-net.by,Website: http://gens.by, http://gens.by,
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Canola modified for the expression of chicken interferon alpha| Belarusian State University | Production of medical or pharmaceutical compounds (human or animal) (Vaccines), Selectable marker genes and reporter genes
- State risk assessment.pdf [ Russian ]
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Experts made the conclusion that the risk of the release of canola transgenic form into the potential receiving environment on the experimental field corresponding to the biosafety requirements is average, and the form can be released into the environment for trials on the experimental field territory, should the inflorescences been insulated.
Experts made recommendations on carrying out environmental experiments on the experimental field corresponding safety requirements, recommendations for laboratory testing for the ability to transition to a secondary seed dormancy and the possibility of hibernation, which can be conducted in parallel with the field trials.
In carrying out experimental research on the experimental field without inflorescence isolation possibility of transition of the target gene encoding chicken alpha interferon and marker bar gene to rape forms and wild relatives using polymerase chain reaction to the target and marker genes should be monitored.
Expert made recommendations on the need to develop a more sensitive PCR method for the detection of target and marker genes with an aim to their subsequent monitoring in case of commercial use after passing the environmental, medical and biological testing and State Trials of a new variety.
The recommendations on the need to determine the copy number of the target and the selective genes and their expression levels in case of release of canola varieties on the market on the basis of a transgenic form of rape are made.
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Experts made recommendations on carrying out environmental experiments on the experimental field corresponding safety requirements, recommendations for laboratory testing for the ability to transition to a secondary seed dormancy and the possibility of hibernation, which can be conducted in parallel with the field trials.
In carrying out experimental research on the experimental field without inflorescence isolation possibility of transition of the target gene encoding chicken alpha interferon and marker bar gene to rape forms and wild relatives using polymerase chain reaction to the target and marker genes should be monitored.
Expert made recommendations on the need to develop a more sensitive PCR method for the detection of target and marker genes with an aim to their subsequent monitoring in case of commercial use after passing the environmental, medical and biological testing and State Trials of a new variety.
The recommendations on the need to determine the copy number of the target and the selective genes and their expression levels in case of release of canola varieties on the market on the basis of a transgenic form of rape are made.
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |