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FAQ

Biosafety is a term used to describe efforts to reduce and eliminate potential risks arising from the use of modern biotechnology or Living Modified Organism (LMO) and its results so that it is safe for human, plant and animal health, environment and biological diversity.

The Biosafety Act 2007 [Act 678] was enacted to establish the National Biosafety Board to regulate the activities of the release, importation and use of modified living organisms and such products, with a view to protecting human health, plants and animals, the environment and biological diversity .

The National Biosafety Board (NBB) is chaired by the Secretary General of the Ministry of Natural Resources and Nature Sustainability. Members consist of representatives from the Ministry of Agriculture and Food Industry (MOA), Ministry of Health Malaysia (MOH), Ministry of International Trade and Industry (MITI), Ministry of Plantation Industries and Commodities (MPIC), Ministry of Science, Technology and Innovation (MOSTI), Ministry of Domestic Trade and Consumer Affairs (KPDNHEP) and 4 experts in the field of biosafety. The Director General of the Department of Biosafety acts as the Secretary of NBB.
The primary role of the National Biosafety Board (LBK) is to make decisions for all applications and monitor activities in relation to living modified organisms (LMOs) and their outcomes.

Currently, the Biosafety Department (JBK) does not have a branch and the address of JBK is:

Department of Biosafety
Ministry Of Nature Resources and Nature Sustainability
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
Federal Government Administrative Centre
62000 Putrajaya, Malaysia

 
Living Modified Organism (LMO) or adapted living organisms are living organisms that have a new combination of genetic material obtained through the use of modern biotechnology
An LMO and a non -LMO product cannot be physically distinguished and an LMO product can only be detected through laboratory experiments.
No. The department only issues certificates of approval from the National Biosafety Board for applications for emissions and R&D activities involving LMOs.
Section 61 of the Biosafety Act 2007 requires all LMOs and their products to be labeled. The labeling requirement is in addition to any other written law. The labeling of foods containing LMO or its products is subject to the Food Act 1983.
The detection of an LMO product can be done through protein analysis using Rapid Test Kit and Deoxyribonucleic Acid (DNA) method through polymerase chain reaction (PCR).
The analysis to detect LMO is carried out by an analyst appointed under Section 55 of the Biosafety Act 2007 where it is currently dilaksanakan di Jabatan Kimia Malaysia (KIMIA Malaysia), MOSTI; Makmal Kesihatan Awam Kebangsaan (MKAK), MOH; ​Makmal ​Keselamatan dan Kualiti Makanan (MKKM), MOH; dan Institut Penyelidikan Perhutanan Malaysia (FRIM), Kementerian Sumber Asli dan Kelestarian Alam (NRES).
Samples can be sent to the Biosafety Department to find out whether a product is LMO or not. The Department of Biosafety will send the sample to an agency that has been designated for LMO detection analysis.
At the global level before an LMO or its products can be commercialized then it needs to undergo several risk assessments to ensure safety for human, animal and plant health. In Malaysia, the regulation of LMO and its results is implemented with the Biosafety Act 2007 to ensure that food and products containing LMO are safe to eat.
One of the purposes of crop production through modern biotechnology is to increase agricultural or plantation output as well as reduce the cost of agricultural or plantation operations such as the purchase of herbicides.
Biosafety guidance documents related to risk assessment and LMO handling can be downloaded here. Borang G
The Department of Biosafety does not issue a permit for the importation of an LMO product and its products. The import permit can be obtained from the Department of Quarantine and Inspection Services Malaysia (MAQIS).

All LMO products to be imported must obtain approval from the National Biosafety Board (LBK). Technology developers should fill Form CCompleted applications must be sent to the Biosafety Department by post or hand delivered to the address:

Director General
Department of Biosafety
Ministry Of Nature Resources and Nature Sustainability
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
Federal Government Administrative Centre
62000 Putrajaya, Malaysia
1) 1) If the microorganism is an LMO, then it needs to obtain approval from the National Biosafety Board (NBB) through the Department of Biosafety. In addition, joint approval from the following agencies is also required: 
i) i) Disease Control Division, MOH for human -related microorganisms;
ii)Jii) Department of Agriculture, MOA for microorganisms related to agriculture; and
iii) Department of Veterinary Services, MOA for animal -related microorganisms. 

2) 2) If the microorganism does not involve LMO, then only need to contact the relevant agency as per item (1) above.
The application process period involving LMO to obtain National Biosafety Board (LBK) Approval is as follows:
1) Release activity: Application for Approval within 180 working days
2) Controlled use activities: Application for Notification within 90 working days.
LMO related applications for controlled use activities/Notification applications, no fee is charged. However, for LMO clearance application/ Approval application, please refer here for more information. Services  for more information.
Individuals/Organizations that bring in LMO or its products that have not been approved by NBB will be subject to legal action under the Biosafety Act 2007 [Act 678].
Contact the Institutional Biosafety Committee (IBC) at the respective institution / company.
Sir/Madam's institution needs to fill Form G for IBC registration and send complete documents to the address:
Director General
Department of Biosafety
Ministry Of Nature Resources and Nature Sustainability
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
Federal Government Administrative Centre
62000 Putrajaya, Malaysia
For information, currently the Biosafety Department does not take students for industrial training.

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