Malaysia | BCH-RA-MY-108757 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 17 May 2022
General information
RISK ASSESSMENT REPORT OF THE GENETIC MODIFICATION ADVISORY COMMITTEE (GMAC) FOR AN APPLICATION FOR APPROVAL FOR RELEASE OF TRANSGENIC RUBBER (Hevea brasiliensis) TREES FOR CONFINED FIELD TRIAL FOR RESEARCH AND DEVELOPMENT PURPOSE
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16 Jun 2015
  • - Competent National Authority: BCH-CNA-MY-48230-13 | BCH-CNA-MY-48230-13
    Competent National Authority
    Department of Biosafety Malaysia ()
    Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1
    Putrajaya,
    62000, Malaysia
    Phone: +603 80917 317,
    Fax: +603-8091 7371,
  • - Person: Dr. Norwati Adnan | BCH-CON-MY-254013-4
    Person
    Dr. Norwati Adnan
    Director, Department of Biosafety
    Department of Biosafety, Ministry of Environment and Water Ministry of Environment and Water, Level 4, Block F11, Complex F, Lebuh Perdana Timur, Precinct 1
    Putrajaya, Putrajaya
    62000, Malaysia
    Phone: +603 - 80917 319,
    Fax:
Risk assessment details
  • Rubber tree modified to express the scFv4715 antibody fragment
    | Dr. Sunderasan Elumalai Production of medical or pharmaceutical compounds (human or animal) - Antibodies and antigens Resistance to antibiotics - Kanamycin
  • Rubber tree modified to express a reporter gene
    | Dr. Sunderasan Elumalai Resistance to antibiotics - Kanamycin Selectable marker genes and reporter genes
  • Rubber tree modified to express Human atrial natriuretic factor
    | Dr. Sunderasan Elumalai Production of medical or pharmaceutical compounds (human or animal) Resistance to antibiotics - Kanamycin
  • Rubber tree modified to express Human Protamine 1
    | Dr. Sunderasan Elumalai Production of medical or pharmaceutical compounds (human or animal) Resistance to antibiotics - Kanamycin
Methodology and points to consider
Please refer to the Risk Assessment  Report.
EN
Please refer to the Risk Assessment Report.
EN
Please refer to the Risk Assessment  Report.
EN
Please refer to the Risk Assessment Report.
EN
GMAC has conducted a thorough evaluation of the application for approval for release of GM rubber (Hevea brasiliensis) trees for confined field trial for research and development purpose and has determined that the confined field trial does not endanger biological diversity or human, animal and plant health. GMAC recommends that the proposed application for confined field trial be APPROVED WITH TERMS AND CONDITIONS as listed in section IV (Proposed Terms and Conditions for Certificate of Approval). GMAC also recommends that Section VI (Identification of Issues to be Addressed for Future Releases) be forwarded to the applicant for further reference.
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Information sharing with other databases
No
Additional Information
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Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1