Advancement in modern biotechnology enables the transfer of genetic material(s) between organisms hence giving rise to creation of living modified organisms (LMOs). The Biosafety Act 2007 was established to regulate any dealing with these LMOs in order to protect human, plant and animal health as well as ecological and biological diversity. Any research dealing with LMOs, besides complying with its safety measures and regulations, must also deal with other related government regulations and policies of safeguarding human health and the environment. The research proposals must be approved and endorsed by MARDI IBC before being submitted to NBB for approval or notification. Further details on the biosafety regulations are available from the Jabatan Biokeselamatan (JBK) website (https://www.biosafety.gov.my).
Biosafety Act 2007
The Biosafety Act 2007 is a Malaysian law that controls activities involving living modified organisms (LMOs) and their products, aiming to protect human, plant, and animal health, as well as the environment and biodiversity, from potential risks associated with modern biotechnology.
The Act establishes the National Biosafety Board (NBB), responsible for regulating the release, importation, exportation, and contained use of LMOs, as well as the release of products derived from such organisms.
The Biosafety Act 2007 can be accessed here: https://www.biosafety.gov.my/assets/document/Akta%20678.pdf
Biosafety (Approval and Notification) Regulations 2010
To facilitate the implementation of the Biosafety Act 2007, Malaysia introduced the Biosafety (Approval and Notification) Regulations 2010, which came into force on November 1, 2010. These regulations outline the detailed procedures for obtaining approval or providing notification for activities involving LMOs.
They specify the requirements for applications related to release activities and importation of LMOs, including the submission of risk assessment reports, proposed risk management measures, and compliance with biosafety levels for contained use activities.
The regulations also detail the roles and responsibilities of Institutional Biosafety Committees (IBCs) in overseeing and monitoring LMO-related activities.
Additionally, the Guidelines for Institutional Biosafety Committees (2010) were issued to assist organisations in establishing and operating IBCs effectively. These guidelines serve as "operating instructions" to ensure that biosafety practices align with national standards.
The regulation can be access here: https://www.biosafety.gov.my/assets/document/akta-dan-peraturan/2-peraturan-biokeselamatan-kelulusan-dan-pemberitahuan.pdf
Genetic Modification Advisory Committee (GMAC)
The function of this Committee is to provide scientific, technical, and other advice related to biosafety to the Minister or the Board.
The Committee also plays a role in assessing and managing risks associated with living modified organisms (LMOs) and their products.
Source: https://www.biosafety.gov.my/main/article/pengenalan-jawatankuasa-penasihat-pengubahsuaian-genetik
Enforcement and Compliance
The Department of Biosafety (JBK) serves as the implementing agency for the Biosafety Act, overseeing the enforcement of regulations and ensuring compliance with biosafety standards.
Violations of the Act and its regulations can result in penalties, including fines and imprisonment, depending on the nature and severity of the offence.
Biosafety (Compounding of Offences) Regulation 2018 can be access here: https://www.biosafety.gov.my/assets/document/akta-dan-peraturan/4-peraturan-peraturan-biokeselamatan-pengkompaunan-kesalahan-2018.pdf
The Biosafety Clearing-House (BCH) serves as a central instrument of the Cartagena Protocol. In this database, the Parties enter information on their genetic engineering regulations and specify which genetically modified organisms (GMOs) may be released into the environment and under what conditions.
List of GM crop events approved in Malaysia can be accessed here: https://bch.cbd.int/protocol/decisions/decision.shtml?decisionID=8298.