Malaysia | BCH-RA-MY-107813 | 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 Approval to Import TMOF_Yeast to Produce Mousticide RH and Mousticide WP and Import of Mousticide WP for Release
EN
12 Feb 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
  • MOUSTICIDE™
    | Mr Mohd Alhafis Rusdi Changes in quality and/or metabolite content - Protein and amino acids
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 the release activities of:
TMOF_yeast imported from India and Mousticide WP Imported from Philippine (which is formulated with TMOF_yeast produced in India) and has determined that the release of this product is safe to human, animal and plant health in quantities as stated in the final product. However, the long term effect on honey bee and oil palm pollinating weevil have not been established.

GMAC recommends that the applicant conduct studies on the effects on local key indicator species in representative areas where Mousticide WP and Mousticide RH will be applied. This applies to the Mousticide WP and Mousticide RH formulated with TMOF_yeast imported from India and produced in IBD, UTM or any other approved facility. If the final product with TMOF_yeast contains a different formulation from the Mousticide WP and Mousticide RH, a new application for approval must be submitted to NBB.


GMAC recommends that the proposed application for release be APPROVED WITH TERMS AND CONDITIONS as listed in section IV - Proposed Terms and Conditions for Certificate of Approval.
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EN
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Information sharing with other databases
Yes
Yes
No
Additional Information
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