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Risk Assessment generated by a regulatory process
(RA)
published: 03 Feb 2015
last updated: 19 Aug 2022
Expert conclusion based on the results of the safety assessment for human health and the environment of transgenic potato plants expressing the genes for antimicrobial peptides of the cecropin and melittin type
EN
15 May 2017
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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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Potato modified for antimicrobial activity| Institute of Biophysics and Cell Engineering | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Bacteria, Fungi)
- Expert`s_conclusion.pdf [ English ]
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The overall environmental risk and risk to human health estimated in case of growing of the transgenic plants developed for research purposes in the territory of the Trial Field, corresponding the safety requirements ("On Safety Requirements for Trial Fields and Other Objects Provided for Testing Nonpathogenic Genetically Engineered Organisms under their First Release into the Environment" of August 29, 2006, N56), is considered as minimal.
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State safety assessment of transgenic potato plants expressing the genes for antimicrobial peptides of the cecropin and melittin type was conducted. It is based on the analysis of data from Dossier submitted by the applicant (SSI "Institute of Biophysics and Cell Engineering, National Academy of Sciences of Belarus"), as well as on the Regulation "On approval of Regulations on the procedure for State Safety Examination of genetically engineered organisms and of approximate terms of contracts concluded for its carrying out, and issuing permits to release of non-pathogenic, genetically engineered organisms into the environment for testing", "Guidance on Risk Assessment of Living Modified organisms" (BCH), "Instruction on the procedure of risk assessment of potential adverse impacts of genetically engineered organisms on human health" (Republic of Belarus).
General conclusions:
1. The risk of release of the transgenic potato forms into the environment for field trials on the Trial Field, corresponding to the relevant safety requirements for the experimental fields designed for genetically engineered non-pathogenic organisms testing (Resolution of the Ministry of Natural Resources and Environmental Protection "On Safety Requirements for Trial Fields and Other Objects Provided for Testing Nonpathogenic Genetically Engineered Organisms under their First Release into the Environment" of August 29, 2006, N56) is acceptable.
2. In the Dossier Applicant (SSI "Institute of Biophysics and Cell Engineering, National Academy of Sciences of Belarus") described methods for removal of genetically engineered organisms at the end of the experiments and for monitoring of genetically engineered organisms, plan of action in emergency situations and contingency that are effective to overcome the long-term adverse effects.
3. Transgenic potato plants expressing the genes for antimicrobial peptides of the cecropin and melittin type developed by the Applicant can be released into the environment for experimental trials within the Field, corresponding to the safety requirements for the experimental fields designed for genetically engineered non-pathogenic organisms testing.
4. Recommendations relating to the experimental study of the transgenic plants developed were given.
EN
General conclusions:
1. The risk of release of the transgenic potato forms into the environment for field trials on the Trial Field, corresponding to the relevant safety requirements for the experimental fields designed for genetically engineered non-pathogenic organisms testing (Resolution of the Ministry of Natural Resources and Environmental Protection "On Safety Requirements for Trial Fields and Other Objects Provided for Testing Nonpathogenic Genetically Engineered Organisms under their First Release into the Environment" of August 29, 2006, N56) is acceptable.
2. In the Dossier Applicant (SSI "Institute of Biophysics and Cell Engineering, National Academy of Sciences of Belarus") described methods for removal of genetically engineered organisms at the end of the experiments and for monitoring of genetically engineered organisms, plan of action in emergency situations and contingency that are effective to overcome the long-term adverse effects.
3. Transgenic potato plants expressing the genes for antimicrobial peptides of the cecropin and melittin type developed by the Applicant can be released into the environment for experimental trials within the Field, corresponding to the safety requirements for the experimental fields designed for genetically engineered non-pathogenic organisms testing.
4. Recommendations relating to the experimental study of the transgenic plants developed were given.
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