Belarus | BCH-RA-BY-112000 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 07 Oct 2022
General Information
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. Re-examination
EN
15 May 2017
Risk assessment details
  • Potato modified for antimicrobial activity
    | Institute of Biophysics and Cell Engineering | Resistance to antibiotics (Kanamycin), Resistance to diseases and pests (Bacteria, Fungi)
Additional information
The Applicant (the Institute of Biophysics and Cell Engineering, NAS of Belarus) submitted a revised Risk Assessment Profile supplemented with new data on risk assessment to the Expert Council on Safety of Genetically Engineered Organisms under the Ministry of Natural Resources and Environmental Protection for review and State Safety Expertize.
As a result of the State Safety Expertise findings related to the transgenic potato forms with inserted gene sequences, encoding peptides of cecropin and melittin type and gene npt II that determine resistance to the antibiotic kanamycin, which are based on the analysis of the data Profile submitted by the Applicant, the Expert selected by the Expert Council for examination, believes that the risk of release of the declared transgenic potato forms into the environment for testing in the trial field complying with safety requirements for trial fields and other objects designed for testing of non-pathogenic genetically engineered organisms is low. Expert considers that the transgenic potato forms with inserted gene sequences encoding peptides of cecropin and melittin type and gene npt II presented by the Applicant can be released into the environment for testing in the trial field that meets safety requirements for trial fields and other objects destined for testing of non-pathogenic genetically engineered organisms. Monitoring technique used for forms – PCR to sequences of targeted and selective genes.
The applicant has elaborated monitoring measures for the cultivation of transgenic forms in the trial field, risk management measures, measures for cleaning up the trial field at the end of a vegetation period that are considered to be effective to overcome long-term adverse effects. The Expert gives recommendations that at the end of a vegetation period the ground part of plants should be destroyed by burning in a cremator.
The expert gave recommendations for ecological experiments, which could be carried out in parallel with field tests in the conditions of the trial field that complies with safety requirements.

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