Abdul Kadir Jailani
Department of Agriculture, Malaysia
Biosafety in Malaysia
Implementing the guidelines
Biotechnology in Malaysia
Assessment and Risk Management in Malaysia
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.
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.
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.
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.
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.
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.
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.
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
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
Malaysian Agricultural Research and Development Institute (MARDI)
Disease resistance in rice, chilli and papaya
Delayed ripening in papaya
Floral colour and senescence in orchids
Palm Oil Board (MPOB) Yield improvement
Improved oil quality
Production of bio-plastics
Institute, Malaysia (RRIM) Yield improvement
Production of high-value proteins
of Medical Research Medical diagnostic kits
Screening of local herbs for pharmaceutical properties
Kebangsaan Malaysia (UKM) Molecular biology of Burkholderia
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
Genetic studies of high-risk populations on nasopharyngeal carcinoma
Transgenic sweet potato with Japanese encephalitis vaccine for
Putra Malaysia Oil palm expressed sequenced tags (ESTs)
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.
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.
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.
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
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.
For Confined Field Release of Transgenic Papaya Plants for Superior
Post-Harvest Fruit Quality (Delayed Ripening).
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.
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.
For Confined Field Release of Transgenic Oil Palm that is Tolerant
to herbicide Glufosinate Ammonium (Phosphinothricin, Basta 15)
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
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.
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.