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Asia BCH Family

CPB Implementation Experience

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  • 2016-12-14


    Malaysia is a Party to the Convention of Biological Diversity and the Cartagena Protocol on Biosafety. In working towards compliance to the obligations under these agreements, specifically for the CPB, the following initiatives have been carried out.


    The regulatory mechanism for modern biotechnology activities in Malaysia is through the Biosafety Act 2007 and Biosafety Regulations 2010. The Biosafety Act (Act 678) was developed as part of obligations to both the Convention of Biological Diversity and the Cartagena Protocol on Biosafety to derive maximum benefit from the potential of modern biotechnology, while minimizing the possible risks posed by LMOs and products of such organisms to human, plant and animal health, the environment and biodiversity.

    The objective of the Biosafety Act is to protect human, plant and animal health, the environment and biological diversity through regulating the release, importation, exportation and contained use activities of living modified organisms (LMOs) and the release of products of such organisms. Under the Biosafety Act, a National Biosafety Board (NBB) has been set up that is responsible to and implement the law through the Department of Biosafety. The NBB will assess and make decisions by considering recommendations by the Genetic Modification Advisory Board and the relevant government agencies.Where there are threats of irreversible damage and lack of full scientific evidence, the NBB may take the necessary action to prevent such damage and address such situations. Through compliance to the Biosafety Act, it is envisaged that LMOs and its products will be handled in a safe manner and any adverse effects can be deterred.

    The Department of Biosafety was established in 2010 as a Federal department under the Ministry of Natural Resources and Environment, through the upgrading of the Biosafety Core Team that was formed in 2008. The Department is the country’s competent authority functions as a one stop centre for all biosafety activities.


    Several regulatory initiatives have been carried out to positively impact biosafety in Malaysia. A prominent initiative is to make risk assessment; risk management and emergency response plan a mandatory exercise before working in a laboratory. Another initiative is the setup of institutional biosafety committees (IBC) in organizations involved in research and development activities. This institutional level regulatory procedure is for the purpose of providing guidance and monitoring to ensure safe use of modern biotechnology. Further guidance is provided by the Department through the development of the Malaysian Biosafety Handbook. .
    The Malaysian Biosafety Handbook is a collection of five biosafety guidelines and a user’s guide produced by the Department of Biosafety in 2012. The set is reviewed as follow:
       a) User’s Guide to the Biosafety Act and Regulations
       b) Guidelines for Institutional Biosafety Committees
       c) Contained Use Activity of Living Modified Organism
       d) Confined Field Trial of Living Modified Plants in Malaysia
       e) Risk Assessment of Genetically Modified Microorganisms
       f) Environmental Risk Assessment of Genetically Modified Plants in Malaysia

    In addition, a bilingual version of the Cartagena Protocol on Biosafety was reprinted in the national language, Bahasa Melayu, and in English. The document was first published by the Secretariat of the CBD in 2000.

    There are also other publications on other topics such as Liability and Redress, Food Labelling and others are made available on the Malaysian Biosafety Clearing House. Anyone can download a copy of these publications in pdf form for free.

    Through the availability of these tools and initiatives, people’s understanding about biosafety can be increased and incorporate safe practices in modern biotechnology activities.


    Many initiatives have been done to raise awareness about biosafety and provide information about biosafety related activities. Some of it are mentioned as below:

      a) The Biosafety Newsletter is produced by the Department of Biosafety and provides information about activities and recent developments in biosafety and implementation of the Biosafety Act in Malaysia. Toi date, there are 7 issues that have been published.

      b) Biosafety website (www.biosafety.nre.gov.my)
        • Also called the Malaysian Biosafety Clearing House (BCH).
        • The website provides information about the implementation of the Biosafety Act (such as the members of the National Biosafety Board, introduction about the Department of Biosafety, members of the Genetic Modification Advisory Committee, process flow and many others.
        • Upcoming activities and events related to biosafety are highlighted such as trainings and public awareness activities.
        • Any new developments in the implementation of the Biosafety Act are also given such as the latest decisions by the National Biosafety Board on any approvals granted.
        • One important role of the website is to make public announcements of applications for release of LMOs or products of LMO and get input from public so that a decision can be made by incorporating public opinion.
        • Website provides documents that can be downloaded such as the Biosafety Act 2007, Biosafety Regulations 2010, Guidelines and other publications, Biosafety Newsletters, Fact Sheets and decisions of the National Biosafety Board, forms for applications and a lot more.
        • In addition to the website the Department also have a Facebook (Jabatan Biokeselamatan) to disseminate information about biosafety and maintains a Twitter account.

    c) Biosafety Education Video

    This video is part of the Department of Biosafety’s effort to increase public awareness on LMOs and biosafety. The video was produced in both the national language, Bahasa Melayu, and in English, and is approximately 18 minutes long. The video is divided into seven chapters including an introduction to DNA and modern biotechnology, steps in genetic engineering, risks and benefits of genetic engineering, status of LMO development and the Biosafety Act 2007.

    d) Biosafety Q+A

    The Biosafety Q+A (Question and Answer) was initially published as a set of illustrated flash cards to educate the public on the fundamentals of biosafety and its related topics. Later on, the cards were converted into pocket-sized booklets for ease of reference. It is one of the best tools currently available for awareness-raising and engagement. The Biosafety Q+A includes general information on genetics, modern biotechnology, GMOs, as well as facts about the Biosafety Act 2007 while maintaining simplicity with the usage of laymen terms and attractive Illustrations.
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