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)
  |  
BCH-RA-MY-108757-2   |   PDF   |   Print   |  
published: 18 Sep 2015 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
Risk assessment details
  • Rubber tree modified to express the scFv4715 antibody fragment
    | Malaysian Rubber Board(LGM) | Production of medical or pharmaceutical compounds (human or animal) (Antibodies and antigens)
  • Rubber tree modified to express a reporter gene
    | Malaysian Rubber Board(LGM) | Selectable marker genes and reporter genes
  • Rubber tree modified to express Human atrial natriuretic factor
    | Malaysian Rubber Board(LGM) | Production of medical or pharmaceutical compounds (human or animal)
  • Rubber tree modified to express Human Protamine 1
    | Malaysian Rubber Board(LGM) | Production of medical or pharmaceutical compounds (human or animal)
Methodology and points to consider
Please refer to the Risk Assessment  Report.
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Please refer to the Risk Assessment Report.
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Please refer to the Risk Assessment  Report.
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Please refer to the Risk Assessment Report.
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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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