Malaysia recognizes the twin aspects of modern biotechnology being the great potential offered by modern biotechnology and the need to protect human health and the environment from the possible adverse effects of biotechnology products.
Genetically Modified Organisms (GMOs) are produced via Genetic Modification (GM) technology are one of the main products from biotechnology. These organisms have been genetically altered in a way and do not occur naturally. Genetic Modification (GM) techniques have given rise to new breeds of plants and animals which are used as food and this has led to a serious debate as to whether these organisms may possibly create risks to the human health and the environment.
In Malaysia, the Biosafety Act 2007 established a process to vet all applications for direct release of living modified organisms (LMOs) into the environment to ensure that the particular LMO is safe (it has to be noted the term LMOs and GMOs are used interchangeably). Biosafety refers to the procedure to avoid harm to human health and environment via the use or release of products of biotechnology into the environment. In the said Act, the term LMOs is used instead of GMOs. There is a debate on the definition of LMOs as used in the Act as compared to GMOs. However, Malaysia has made a declaration in the Convention of Biodiversity 1994 that the former term gives meaning to the latter.
In the Act, there are two different scopes of activities dealing with LMOs. Part III deals with release activities and importation of LMOs while Part IV mainly concerns in which LMOs used for contained use and exportation. Release activities involve research and development (R&D) purposes in all field experiments; placing in the market; offer as gift, prize or free item, disposal and remediation purpose. The application for approval is vetted by Genetic Modification Advisory Committee (GMAC) – consisting almost entirely of scientists that will make its recommendation to the National Biosafety Board (the Board) for its decision. This Board consists of the representatives of all the relevant Ministries – Ministry of Natural Resources and Environment, Ministry of Science, Technology and Innovation, Ministry of Agriculture and Agro-based Industry, Ministry of Health, Ministry of Plantation Industries and Commodities, Ministry of Domestic Trade and Consumer Affairs, Ministry of International Trade and Industry as well as any person who may have specialized knowledge or experience in biosafety related issues. No more than four such persons may be appointed by the Minister to the Board. Any person, who is found guilty of contravening Part III, shall be liable for a fine not exceeding RM 250,000 or imprisonment not exceeding 5 years, or both for an individual. As for a body corporate, they are liable for a fine of not exceeding RM 500,000.
For the exportation of LMOs, the exporters are required to comply with requirements set up by the importing country. The applicants should inform the Board of their intentions through a notification form. This form will be submitted with prescribed fees and together with an emergency response plan, specific measure for contained use activity and such other information as specified by the Board. The Board has the discretionary power to review the notification at any time if there is any likelihood of danger to human health and environment. Any person, who is guilty of contravening Part IV, shall be liable for a fine not exceeding RM 250,000 or imprisonment not exceeding 4 years, or both for an individual. As for a body corporate, they are liable for a fine of not exceeding RM 500,000.
Section 3 of the Act, defines LMOs as any living organisms that possess a novel combination of genetic materials obtained through the use of modern biotechnology and refers to the process of modifying the genetic material which influences the hereditary characteristics by focusing on the modification process not the terms per se.
Public awareness and public participation, including access to information is acknowledged to be a major tool for realizing the potential and avoiding risks where biotechnology is concerned. According to Section 14, the Director General of Biosafety can invite the public to review applications for the release and import of GMOs. However, this is subject to Section 59 which provides that if such information is confidential, it cannot be given to the public. In addition, it is also recommended that the management activities of modern biotechnology especially matters relating to GMOs is included under the Prescribed Activities in the Environmental Quality (Prescribed Activities)(Environmental Impact Assessment) Order 1987. This will give the public an opportunity to participate through the EIA evaluation.
All GMOs or products derived thereof are required to be identified and labeled. Identification and labeling is contained in the provisions of the Act, which is Section 61. All GMOs and their products shall be clearly identified and labeled in a manner to be prescribed that the requirements for such identification and labeling shall be in addition to any other written law. The reason for labeling is to ensure that products that have undergone the prescribed process are properly and adequately identified so that consumers would know the contents of the product. Without this labeling, consumers do not know whether the food that they consume is genetically engineered or not.
The Malaysian Government has taken into account racial and religious sensitivities. LMOs with certain genes may be anathema or offensive too Muslims, Hindus or Buddhists and other faiths will also be considered and the Board will need to weigh these factors carefully.
Due to the concerns possible risks with the LMO (GMO) organisms, the constitution of the biosafety law in Malaysia is important in advancing the development of modern biotechnology. The Act also contains the provisions on the mechanisms and procedures (i.e. risk assessment and risk management) by which information about LMOs or their presence in the foods or products must be disclosed to importing countries and consumers (such as labeling and identification). Furthermore, public concern and the unknown risks of the GMOs to humans and environment have made disclosure a must. This Act will eventually cover virtually all biotech research and development and perhaps most food imports, production and processing in the country. Moreover, the Act also should be used to assess that the products are safe to use and safe for the environment, humans and animals.
Intellectual property practitioners involved in advising clients in biotechnology would therefore have to note the provisions of the Act when dealing with biotechnology ventures in Malaysia.
Submitted by Siti Hafsyah binti Idris, currently a Law Lecturer and Ph.D Researcher at the Faculty of Law, Universiti Teknologi Mara (UiTM) Shah Alam, Selangor. Her area of research is Biotechnology Law & Bioethics. She may be contacted at firstname.lastname@example.org.