Risk Assessment & Risk Management

Atikah Abdul Kadir Jailani
Department of Agriculture, Malaysia

Biosafety in Malaysia
Implementing the guidelines
Biosafety Law
Biotechnology in Malaysia
Risk Assessment and Risk Management in Malaysia


1. There are various definitions of biotechnology. R. B.Singh in his paper "Potentials and Challenges of Biotechnologies and FAO's Role' defined biotechnology as a continuum of traditional and modern technologies to investigate and manipulate organisms at various levels, from organismal to molecular, to make or modify biological products to meet particular needs. The CBD (Convention on Biological Diversity) defines it as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

2. Biodiversity provides raw materials for various biotechnology industries such as in the pharmaceutical and chemical sectors. The growth of the biotech industry in the past two decades has been closely associated with the systematic search for genetic material and the transformation of this into new products i.e. chemicals and drugs. Genetic resources have increased in value with a major resurgence in screening of genetic resources for their medicinal and biochemical properties.

3. The CBD established a clear link between the supply of genetic resources (from developing to developed countries), and access to and transfer of biotechnology (from developed to developing countries) which make use of these resources. Therefore, collaboration in biotech research to utilize biodiversity is very essential. Developing countries in particular must also invest in biotech infrastructure. There is a need to give priority to biotech development as a strategic sector that would enable the country to derive economic benefits.

4. In Malaysia, the focus of biotechnology work centers on the needs of the nation. Improving food production has been and always be one of the top priority and commitment of government agencies involved in biotech. As far as agriculture is concerned, Malaysia is blessed with a lot of assets and features. The nation is rich in natural resources, blessed with favourable climate for most of the time for tropical agriculture. Malaysia has been a world leader in a number of plantation crop industries, such as oil palm, rubber and cocoa.

5. The economic crisis of the late '90s has prompted us to have a second look and stand on the importance of agriculture, especially in food production to the national economy. The Government has stressed the needs for producing sufficient amount of food for national security and stability. The huge and growing budget for food and feed import clearly indicate the need to transform our agriculture sector in order to produce enough food for the people. Research and development in biotechnology is geared to meet this challenge.

to the top

Biosafety in Malaysia

6. In Malaysia, the Ministry of Science, Technology and the Environment (MOSTE) is the focal point and is responsible for coordinating all matters pertaining to biological diversity including biosafety under the CBD. A Genetic Modification Advisory Committee (GMAC) was established in March 1996 under the ambit of the National Committee on Biodiversity (NCB), MOSTE. Its objective is to ensure that any risks associated with the use, handling and transfer of GMOs be identified and safely managed; and to advise the government about matters on genetic modification technology and its application.

7. Following its establishment, GMAC in January 1997, has formulated the National Guidelines on Release of GMOs Into the Environment as an effort to provide a national framework for addressing biosafety issues with regards to regulation, assessment and management of risk associated with the use and release of GMOs into the environment. GMAC is responsible to monitor and implement the guidelines. The Guidelines require the establishment of Institutional Biosafety Committee (IBC) in all related research government institutions. IBC will ensure that experiments relating to genetic modification and release undertaken by the institution conform to the provisions of the Guidelines. As a result, many universities and government research institutions have established their own IBCs.

to the top

Implementing the guidelines

8. The management of field testing is achieved through cooperation with various research institutions. The IBC is responsible for research work at its own institute, in consultation with the GMAC. The NBC established a secretariat to coordinate matters regarding biosafety. Currently, the importation of GMOs are regulated by sectoral legislation. Application for importation of GMOs are sent to the Director General of the respective Government Department which acts as the competent authority with a copy to the secretariat. For genetically modified plants, permission to import must be obtained from the Department of Agriculture, for genetically modified animals, fish and food from the Department of Veterinary, Department of Fisheries and Ministry of Health respectively. All relevant information and documents concerning the GMOs (nature of genes, gene constructs, transformation process, etc.) has to be submitted to the competent authority and GMAC. The GMAC will, after careful consideration of the proposal, makes recommendation to the competent authority for final consideration and approval.

9. For every stage of experiment/trials i.e. from contained use to placing in the market, proponent has to submit their application to the secretariat for consideration by the GMAC.


10. In order to have an effective system to monitor the field release, NBC, GMAC and the competent authority work very closely. Experts from the competent authority, GMAC and NBC join hands in considering the design of experiment and other aspects of field testing. Reports on the field tests are required will be reviewed by the NBC, GMAC and the respective competent authority.

to the top

Biosafety Law

11. Currently the GMOs are regulated by using the Guidelines formulated by GMAC, and this Guidelines are not law, meaning that there are no provisions to impose penalties to any party not following the guidelines. Genetic engineering is to be promoted with the necessary safeguards so that biotechnological processes are properly regulated along socially and ethically desirable channels. Being a country naturally endowed as one of the 12 megadiversity countries of the world, Malaysia is purported to harbour more than 150,000 species of invertebrates, 286 mammal species, 736 bird species and 15,000 flowering plant species. As such, it is very necessary for this country to carefully regulate the gene technology so as that, apart from things, this vast natural treasure of biodiversity is not adversely affected. The weakness of the GMOs regulations in Malaysia needs to be strengthened through legislative means. Realising this fact, the government in June 1997 has directed GMAC to draft a Biosafety Bill. This Bills seeks to achieve the aforesaid objective.

12. The Malaysian Biosafety Bill has already been tabled at the National Consultation forum in September 2001. Base on the feedback received from the stakeholder during the consultation, some fine tuning needs to be undertaken especially with regards to the policy on scope, labeling, export and contained use. This part of the Bill will be tabled to the Parliament on June 12, 2002 for high level policy decision. The Bill is expected to be ready for discussion in the Parliament for gazette by the end of 2002. This Bill is envisage to be enabling, transparent and practical.

to the top


Biotechnology in Malaysia

13. Biotechnology receives large-scale support from the Malaysian government. Biotechnology is earmarked as one of the areas of advancement under the 8th Malaysia Plan (2001-2005). To accelerate biotechnology development in Malaysia, the Ministry of Science, Technology and the Environment (MOSTE) set up the National Biotechnology Directorate (BIOTEK) in May 1995. BIOTEK is entrusted with the task of spearheading and coordinating biotechnology research in Malaysia.
14. To streamline biotechnology research, BIOTEK established seven biotechnology cooperative centres (BCC) in the areas of plant, food, animal, molecular biology, medical, environment/industry and biopharmacy. The BCCs help to coordinate biotech research in the various research organisations to improve cooperation and reduce duplication.
The following is the list of research organizations and their research emphasis:
Organisation Research
Malaysian Agricultural Research and Development Institute (MARDI) Disease resistance in rice, chilli and papaya
Delayed ripening in papaya
Floral colour and senescence in orchids

Malaysian Palm Oil Board (MPOB) Yield improvement
Improved oil quality
Production of bio-plastics

Rubber Research Institute, Malaysia (RRIM) Yield improvement
Disease resistance
Production of high-value proteins

Institute of Medical Research Medical diagnostic kits
Screening of local herbs for pharmaceutical properties

Universiti Kebangsaan Malaysia (UKM) Molecular biology of Burkholderia pseudomallei
Antibody engineering
Gene and genome analysis of Anopheles maculates
Molecular biology of protozoan parasites
Molecular studies of Glomerella cingulata and its pathogenesis of Cry proteins
Molecular systematic studies of wildlife and domestic animals

Universiti Malaysia Sarawak Screening of local plants for anti-malarial drug
Genetic studies of high-risk populations on nasopharyngeal carcinoma (nasal cancer)
Transgenic sweet potato with Japanese encephalitis vaccine for pigs

Universit Putra Malaysia Oil palm expressed sequenced tags (ESTs)
Plant transformation
Gene expression
Floral/ meristem/ embryo development
Plant defence stress response

18. Biotechnology in Malaysia recently received a further boost with the announcement of the BioValley initiative. The BioValley will consist of a concentration of Biotechnology research institutions, universities and companies withinthe Multimedia Super Corridor (MSC). BioValley will include three new research institutions conducting research in genomics and molecular biology, nutraceuticals and pharmaceuticals, and agricultural biotechnology.

19. Another initiative to boost biotechnology in Malaysia is the Malaysia-MIT Biotechnology Partnership Programme (MMBPP). It is a collaborative effort between Malaysian academic, industrial and government research organizations, including six BCCs, through Malaysia's National Biotechnology Directorate and the Massachusetts Institute of Technology (MIT). The programme is supported by the MOSTE. The primary goal of this partnership is to build a foundation for a sustainable biotechnology industry in Malaysia through research development, as well as human resource training.

20. This programme hopes to facilitate the interaction, development and training of scientists in critical areas like genomics, bioinformatics and bioprocessing through the exchange of Malaysia and MIT research personnel. The aim of the training is to develop a group of professionals who will be able to spearhead the development of biotechnology industry in Malaysia.

to the top

Risk Assessment and Risk Management in Malaysia

21 In Malaysia, all research on genetically modified organisms (GMOs) irrespective of origin is still in the experimental phase and under confined use. To date, Genetic Modification Advisory Committee (GMAC) of Malaysia has undertaken three risk assessment exercises as follows:

a. Safety Assessment of the Import of Transgenic Soyabean (Glycine max) into Malaysia for Food and Feed

22. In October 1996, the Malaysian government received an application for the import of transgenic soyabeans for food and feed into the country. That application was the first which the GMAC of Malaysia was requested to undertake a risk assessment for the release of a genetically modified organisms into the environment. The transgenic organisms was theglyphosate-tolerant "Roundup Ready Soyabean, produced by Monsanto Co. (USA).

23. "Roundup Ready Soyabean" was deregulated in the USA since May 1994. Thus the beans would not be differentiated from the conventional (non-transgenic) soyabeans when they are imported into the country. The glyphosate-tolerant soyabeans (GTS), line 40-3-2 contain two novel constituents, namely, the enolpyruvateshikimate-3-phosphate synthase (EPSPS) gene derived from Agrobacterium sp. Strain CP4 and its gene product, the EPSPS enzyme. Risk assessment was based primarily on scientific data provided by the proponent, information derived from literature search and similar risk assessment of the same genetically modified organisms (GMOs) conducted in other countries.

24. Based on the available data, GMAC concluded that Roundup Ready Soyabean line 40-3-2 was not different from conventional soyabeans and was safe for import into the country for food and feed. In addition, it was not hazardous to agriculture and the environment and was unlikely to become a weed pest.

b. Assessment For Confined Field Release of Transgenic Papaya Plants for Superior Post-Harvest Fruit Quality (Delayed Ripening).

25. Malaysian Agriculture Research and Development Institute (MARDI) has submitted an application for a confined field release of transgenic papaya modified for delayed ripening, to the GMAC in January 2002.

26. Risk assessment was based primarily on the data provided by the proponent. Based on the available data, GMAC concluded that transformed papaya with antisense ACC oxidase cDNA sequence is safe to eat and is not hazardous to agriculture and environment. Therefore, GMAC approved the confined field release be performed in a netted house as requested by proponent.

c. Assessment For Confined Field Release of Transgenic Oil Palm that is Tolerant to herbicide Glufosinate Ammonium (Phosphinothricin, Basta 15)

27. The application for confined field release of transgenic oil palm was submitted by the Malaysian Palm Oil Board (formerly known as PORIM - Palm Oil Research Institute of Malaysia) in March 2002.

28. Risk assessment was also based on data provided by the proponent. Based on the data provided, GMAC was not convinced on the location of the field release and require additional information. Proponent was requested to submit a new location for the confine field release and furnish GMAC with the additional information required.


29. The Malaysian government is well aware of the potential benefits of genetically modified crops, however it has the responsibility to assure the public of the safety of the genetically modified crops as well as to safeguards against their adverse (if there is any) effects on human health and the environment. Malaysia along with other ASEAN member countries are supportive of activities that relate to Biosafety capacity building. Activities such as practical training programes in risk assessment and management would be supportive of Malaysia's as well as ASEAN needs.

to the top