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Country's Decision or any other Communication
Record information and status
Record ID
105630
Status
Published
Date of creation
2014-06-24 05:50 UTC (johnny@nre.gov.my)
Date of last update
2020-08-03 06:56 UTC (anita@biosafety.gov.my)
Date of publication
2020-08-03 06:56 UTC (anita@biosafety.gov.my)

General information
Country submitting the decision or communication
  • Malaysia
Competent National Authority(ies) responsible for the decision or communication
Department of Biosafety Malaysia
Level 1, Podium 2, Wisma Sumber Asli
No. 25, Persiaran Perdana, Precinct 4
Putrajaya
Malaysia, 62574
Phone:+603 8886 1579,+603 8886 1746
Fax:+603-8890 4935
Email:dob@biosafety.gov.my
Url:Department of Biosafety Malaysia
Title / Reference number of the decision or communication
JBK(S) 602-1/1/5
Date of the decision
2011-07-26
Is the decision taken prior to entry into force of the Protocol?
No
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Mr Mohd Alhafis Rusdi
Technology Officer
EntoGenex Industries Sdn. Bhd.
D-3A-08, Plaza Mont' Kiara, No 2 Jalan Kiara, Mont' Kiara
Kuala Lumpur
Malaysia, 50480
Phone:+603 6203 5531/5532
Email:al@entogenex.com
Url:http://entogenex.com/2014/
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
PART A
INFORMATION AND/OR DOCUMENTATION THAT SHALL BE SUBMITTED TO THE NATIONAL BIOSAFETY BOARD (NBB) BEFORE RELEASE
1) The applicant is required to provide information on the manufacturing plant's Biosafety Level (BSL) and data on the heat kill process. The quality control procedure shall be properly validated or modified to ensure that the heat kill process is sufficiently effective for a 6-log reduction in the number of viable cells.
2) If the Chemical Engineering Pilot Plant (CEPP) in Universiti Teknologi Malaysia, Johor, is the facility to be used for production of TMOF_Yeast, the specific conditions imposed by the Genetic Modification Advisory Committee (GMAC) as listed in Part C shall be adhered to and complied with to ensure containment and proper management.
3) Proof of compliance to these conditions must be provided through a visit to the facility by GMAC members.
4) If the production is to be done in a facility other than CEPP, a Notification of that chosen facility for contained use activity must be submitted to the National Biosafety Board.

PART B
CONDITIONS FOR THE RELEASE
1) Release is limited to TMOF _Yeast (Technical Grade Active Ingredient, TGAI) in the formulations of MOUSTICIDE™ Wettable Powder (WP) and MOUSTICIDE™ Rice Husk (RH) as end products. For any other formulation, or if TMOF_Yeast is produced again in another facility, reassessment by NBB and GMAC are required.  
2) Both MOUSTICIDE™ products shall not be applied to water bodies and waterways such as finished, treated drinking water sources.
3) The requirement for proper labeling is imposed; product handling and safety instructions shall be provided together with the products. These instructions shall include the need for personal protective equipment (PPE) and proper usage procedures covering notification and follow-up medical monitoring of staff handling the product.
4) Post-release environmental monitoring shall be undertaken by the applicant to negate long-term cumulative effects on the oil palm weevil, other non-target organisms (in particular aquatic organisms) and human health from repeated applications of MOUSTICIDE™WP and MOUSTICIDE™ RH.
5) The applicant shall conduct thorough studies in the following areas and to report the progress and results of these studies to NBB on a quarterly basis from the date of approval. The final results of these studies shall be communicated to the Board within 24 months of the date of approval:
i) Possible toxic effects on the oil palm pollinating weevil. More comprehensive and properly designed studies are needed, using laboratory-reared weevils of the same age, to (a) examine  egg development and oviposition  by treated adult females (vis-a-vis an untreated check) because there is a possible implication on egg development; and (b) examine the conditions of the midgut peritropic membrane of the weevils which survive but may have been impaired in terms of subsequent development;
ii) Effect of MOUSTICIDE™WP and MOUSTICIDE™ RH on local fauna. These studies are  to establish the toxicology of Mousticide on (a) Focal local insect species that were not covered in the EPA report which  are significant to other plants/crops (e.g. cocoa, rubber, pepper, rice, etc.); and (b) Focal species of aquatic organisms because applications are targeted on aquatic environments;
iii) Synergistic effect of TMOF with other biopesticides. These studies  are to determine the  possibility that combining TMOF with Bti or other biopesticides may lead to an increased spectrum of non-target organisms, or an increased toxicity level in mildly-affected organisms; and
iv) Impact of TMOF/ MOUSTICIDE™WP and MOUSTICIDE™ RH on human health. These studies are to examine the impact of TMOF/ MOUSTICIDE™WP and MOUSTICIDE™ RH on human health from repeated exposure to the insect proteins via inhalation or skin contact during the spraying of the wettable powder in an aquatic environment which is likely to happen if PPE is not used.

PART C
ACTIONS FOR IMPROVEMENT OF MANAGEMENT FOR THE CONTAINED USE FACILITY AT THE CHEMICAL ENGINEERING PILOT PLANT (CEPP), UNIVERSITI TEKNOLOGI MALAYSIA (UTM)
Following up on the visit by representatives of GMAC to the three facilities (Cell Propagation Room, Bioprocessing Facility and Spray Drying Facility at CEPP, UTM) on 6 October 2009, a few specific conditions were imposed on the applicant as conditions that are to be complied with. These conditions include an improvement to facility design, administrative controls and engineering controls. Compliance to the imposed conditions shall be evaluated by GMAC.
Reasons
This is to ensure that the product will not endanger the environment, human and animal health including non target organism.
Does the decision involve field trials?
No
Does the decision involve commercial release?
Yes
LMO identification
MOUSTICIDE™
Mr Mohd Alhafis Rusdi Changes in quality and/or metabolite content - Protein and amino acids
Risk assessment
Risk Assessment Report of the GMAC for an Approval to Release Products of TMOF_yeast
MOUSTICIDE™
Mr Mohd Alhafis Rusdi

Changes in quality and/or metabolite content - Protein and amino acids