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Country's Decision or any other Communication
Record information and status
Record ID
115311
Status
Published
Date of creation
2019-12-12 07:44 UTC (anita@kats.gov.my)
Date of publication
2019-12-12 07:44 UTC (anita@kats.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:biosafety@kats.gov.my
Url:Department of Biosafety Malaysia,Ministry of Water, Land and Natural Resources Malaysia
Title / Reference number of the decision or communication
JBK(S) 600-2/1/6
Date of the decision
2019-12-10
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
Dr. Rogayah Sekeli
Plant Transformation and Molecular Biologist
Biotechnology and Nanotechnology Research Centre
Malaysian Agricultural Research and Development Institute (MARDI)
MARDI Headquarters, Persiaran MARDI-UPM
Serdang, Selangor
Malaysia, 43400
Phone:+603 89537313
Email:lynn@mardi.gov.my
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Part A: Actions to be taken and reported to the National Biosafety Board prior to the start of the field trial

(i) A consent letter to conduct the confined field trial from the Local Council for the district where the site is located shall be provided. 
(ii) Proper signage shall be present at the trial site informing of the presence of genetically modified papaya as according to the Confined Field Trial Guidelines. Access to the confined field trial site shall be limited to authorised personnel only.
(iii) Appropriate training shall be given to all personnel who will be handling the genetically modified papaya. 
(iv) Pest and animal control measures shall be in place at the confined field trial site.
(v) The owner of the plot of land on which the confined field trial site is situated (MARDI or other parties) must consent, in writing, to a post-trial land use restriction period of 6 months. 
(vi) An Emergency Response Plan shall be prepared and approved by Genetic Modification Advisory Committee to handle possible incident of breach in containment.


Part B: Actions to be taken and reported to the National Biosafety Board during the field trial

(i) The approved Standard Operating Procedures (SOPs) for transportation of all genetically modified papaya and materials from the greenhouse to the confined field trial site shall be adhered to. Records shall be kept for all genetically modified papaya transported to the confined field trial site. 
(ii) An isolation zone shall be established, whereby the confined field trial site must be separated by a distance of at least 400 metres from other papaya plants on all sides.
(iii) Regular inspections shall be carried out to ensure that there are no volunteers (papaya and wild relatives) in the vicinity of the isolation zone. Any volunteers found shall be collected and destroyed. A record of this inspection exercise and of the numbers of volunteers destroyed shall be maintained.
(iv) If a breach of the isolation zone should occur, the National Biosafety Board shall be informed immediately and random sampling and testing shall be conducted to ensure no outcrossing of genetically modified papaya.
(v) The Emergency Response Plan approved by Genetic Modification Advisory Committee must be implemented to handle any incident of breach in containment.
(vi) Records of all seeds and other plant materials that are removed from the trial site for storage or analysis off-site shall be kept. The SOPs for transporting such materials shall be strictly adhered to.
(vii) Bioinformatics data analysis on potential toxicity and allergenicity of the expressed proteins shall be submitted to the National Biosafety Board.
(viii) Appropriate and continuous training shall be provided to personnel who will be handling the genetically modified papaya plants.
(ix) Pest and animal control measures shall be implemented. Regular inspection of the net house shall be carried out to ensure its integrity at all times.
(x) The Biosafety related approved SOPs that have been approved under this application shall be strictly adhered to and personal protection equipment shall be used to avoid exposure.
(xi) No changes shall be made to the Biosafety related SOPs that have been approved under this application. Any changes proposed shall be submitted to and approved by Genetic Modification Advisory Committee.
(xii) Additional conditions may be imposed based on monitoring visit by Department of Biosafety and these conditions shall be complied with.
(xiii) Should the approved person receive any scientifically proven information that confirms any adverse effect of transgenic papaya, the National Biosafety Board shall be informed.


Part C: Actions to be taken and reported to the National Biosafety Board at termination of the field trial

(i) No parts of the genetically modified papaya plants from this confined field trial shall be consumed or utilised for any other purpose other than this trial.
(ii) At the termination of the field trial, all residual plant materials in the confined field trial site shall be rendered non-viable using methods approved by Genetic Modification Advisory Committee. The confined field trial site and the isolation zone are subjected to post-trial land use restrictions for a period of 6 months.  
(iii) During this 2-year period, the confined field trial site and the isolation zone shall not be planted with any plants without prior approval from the National Biosafety Board. The confined field trial site and isolation zone shall be continuously monitored for growth of papaya volunteers, which shall be collected and destroyed. Proper records of these post-trial activities shall be maintained and the report submitted to the National Biosafety Board upon the expiry of the post-trial period.
Reasons
This is to ensure that the confined field trial does not endanger biological diversity or human, animal and plant health
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Papaya modified for resistance to Papaya Dieback Disease
Dr. Rogayah Sekeli Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Bacteria Resistance to Gram-negative bacteria
Risk assessment
RISK ASSESSMENT REPORT OF THE GENETIC MODIFICATION ADVISORY COMMITTEE (GMAC) FOR AN APPLICATION FOR APPROVAL FOR CONFINED FIELD EVALUATION OF TRANSGENIC EKSOTIKA PAPAYA AGAINST PAPAYA DIEBACK DISEASE
Papaya modified for resistance to Papaya Dieback Disease
Dr. Rogayah Sekeli

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Bacteria
Resistance to Gram-negative bacteria
Additional Information
Other relevant website address or attached documents