Malaysia ratified the Cartagena Protocol on Biosafety in 2003 and passed the Biosafety Act in August last year. The Biosafety Act is scheduled to come into force this year and Section 61 requires the identification and labelling of living modified organisms (LMOs) and their products, including genetically modified (GM) food.

Malaysia has long provided patent protection for new and useful biotechnological inventions and in January 2007 passed the Protection of New Plant Varieties Act 2004, conferring protection to plant breeders in relation to the new plant varieties they developed.

Biosafety Act

With the coming into force of the Biosafety Act, scheduled for this year, the modern biotechnology industry in Malaysia will have to comply with the framework set out therein to regulate the release, importation, exportation and contained use of LMOs and the release of products of such organisms.

The objectives of the Biosafety Act are to protect human, plant and animal health, the environment and biological diversity. In line with the Cartagena Protocol, it adopts the precautionary principle: where there are threats of irreversible damage, lack of full scientific evidence may not be used as a reason not to take action, as appropriate, to prevent such damage.

LMOs and products of LMOs

LMOs are defined as any living organisms possessing a novel combination of genetic material obtained by the use of modern biotechnology. "Living organisms" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids, whereas "modern biotechnology" is defined as the application of: (a) in-vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles; or (b) fusion of cells beyond the taxonomic family that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

Products of LMOs are defined as any product derived from an LMO or part of an LMO if: (a) the product contains detectable recombinant DNA; or (b) where the profile, characteristic or properties of the product is or are no longer equivalent to its conventional counterpart irrespective of the presence of the recombinant DNA.

The Biosafety Act regulates two categories of activities in relation to LMOs: (a) the release and importation of LMOs; and (b) the export, contained use and import for contained use of LMOs.

Application for the release and importation of LMOs, Part III of the Biosafety Act

An application for approval has to be made to the Director General of Biosafety (DG) for any release activity or importation of LMOs. "Release activity" is defined as any intentional introduction of LMOs or products of such organisms into the environment for research and development purposes in all field experiments, supply or offer to supply for sale or placing on the market, offer as a gift, prize or free item, for disposal, remediation purposes or any other activity that does not amount to contained use of LMOs.

The application must be submitted together with the prescribed fees, a risk assessment and risk management report, an emergency response plan and such other information as specified by the National Biosafety Board (Board). The DG will refer the application to the Genetic Modification Advisory Committee (GMAC) for its recommendation. This application procedure is in line with advance informed agreement under the Cartagena Protocol, where the exporter is required to seek consent from an importing country before the first shipment of an LMO.