Status of Biotechnology Regulation with Emphasis on Public ...


Dec 1, 2012 (4 years and 4 months ago)


Status of Biotechnology Regulation with Emphasis on
Public Participation and Awareness in Malaysia


Wan Kelthom Wan Hassan

Biolotechnology statement by Malaysia’s Prime Minister:

“…that biotechnology had great potential in Malaysia and it could
be a c
atalyst for new growth areas in the country’s economy as well as a
source of new wealth and income for the people. Biotec is useful in
many areas

agriculture, livestock farming, herbal industry and
traditional and modern medicine.” Kuala Lumpur 15 June



Biotechnology is nothing new. However of late, there is global concern
over the genetically modified (GM) crops

one of the products of
biotechnology. The Malaysian government is well aware of the
potential benefits of biotechnology
programs. However, she has the
responsibility to assure the public of the safety of the biotechnology
products as well as to safeguard against their adverse effects on the
environment. Towards this end, the government as the implementors
has to ensure that

the biotechnology programs go hand in hand with
programs to get public participation and awareness.

Recent developments in Biotechnology in Malaysia

Presently biotechnology receives large
scale support from the
Malaysian government. Biotechnology is earma
rked 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 Innovations (MOSTI) set up the National
Biotechnology Directorate (BIOTEK) in May
1995. BIOTEK is entrusted
with the task of spearheading and coordinating biotechnology research
in Malaysia.

To streamline biotechnology research, BIOTEK established seven


biotechnology cooperative centres (BCC) in the areas of plant, food,
animal, molecu
lar biology, medical, environment/industry and
biopharmacy. The BCCs help to coordinate biotech research in the
various research organisations to improve cooperation and reduce

Several research organizations and universities are leading the w
ay in
biotechnology research such as Malaysian Agricultural Research and
Development Institute (MARDI) in disease resistance in rice, chilli and
papaya; Malaysian Palm Oil Board (MPOB) in yield improvement and

improved oil quality of oil palm and the Inst
itute of Medical Research in
screening of local herbs for pharmaceutical properties.

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

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
MOSTI. The primary goal of this partnership is to build a foundation for
a sustainable biotechnology indu
stry in Malaysia through research
development, as well as human resource training.

Biosafety in Malaysia

In Malaysia, MOSTI 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). Its objective is to ensure that any
risks associated with the use, handling and transfer of GMOs be
ied and safely managed; and to advise the government about
matters on genetic modification technology and its application.


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 guid
elines. 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.

Implementing the guidelines

The management of field testing is achieved through cooperation with
various research ins
titutions. 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
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 t
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
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.

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.


In order to have an effective system to monitor the field release, NBC,
C 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 required will be reviewed by the NBC, GMAC

and the
respective competent authority.

Biosafety Law

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
idelines. 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 countr
ies 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.

The Malaysian Biosafety Bill has already been tabled at the National
Consultation forum in September 2001. Based on the feedback
received from the stakeholder dur
ing 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 Bi
ll is expected to be ready for discussion in the
Parliament for gazette by the end of 2002. This Bill is envisaged to be
enabling, transparent and practical.

Public participation and awareness

Biotechnology is a public issue. It concerns what people eat,
clothes people wear and almost everything they use every day, as well
as the environment they live in. There is a need for the authorities to
address the safety issues with transparency and in a responsible
manner. Of utmost importance is to give the
people an understanding
of the matter at hand, the potential benefits and perils, eventually to
enable them the freedom of making the right choice. The government
must be seen to be doing a good job in dissemination of biotechnology
information and at the
same time giving a channel for feedback.


In Malaysia, the government is doing the information dissemination on
biotechnology through MOSTI, specificly BIOTEK through its
promotional programs to educators and high school students (please
see appendix I). BI
OTEK also has a webpage which carries updates of
news and events related to biotechnology for internet users.

Some NGOs have been conducting conferences, seminars and
workshops to create awareness among the government officers, the
media and the public.
Examples are


International Life Sciences Institute (ILSI) Southeast Asia Region
held a series of training workshops on safety assessment of
GMOs in 2001

2002 for government officials of the ASEAN
region. The second workshop was held in Kuala Lumpur on 2

22 August 2002


International Service for the Acquisition of Agri
Applications (ISAAA) and Monash University Malaysia (MUM)
with Malaysian Agricultural Biotechnology Centre (MABIC) held a
public seminar on GMOs in March 2001 in Kuala Lumpur. ISA
disseminates information in the form of brochures in different
languages and other print materials


Consumers’ Association of Penang (CAP) is an active exponent of
issues pertaining to the masses. CAP has written on
biotechnology / GMOs in its newslette
r and has produced a
booklet “GMOs

facts that you should know” in Malay and
English. CAP’s president writes regularly on GMOs in national

Is the public aware?

Presently there’s a positive feeling about GMOs and biotechnology in
the country.
More so now that the Prime Minister himself who has just
come back from a biotechnology exposition in USA has expounded on
the virtues of biotechnology. However, the public deserves to know
both sides of the coin.

Surveys by Asian Food Information Centre i
n 1999 and 2002
consistently indicate that the Asian consumers are cautiously
optimistic about the benefits biotechnology would bring to their diet.
The repondents also would like more information. The surveys also
found out that the preferred source of in
formation are mass media
channels such as newspapers.


The communication challenge

So far no official survey has been known to have been conducted
to determine the knowledge level and attitude towards biotechnology /
GMOs in Malaysia. Malaysia needs a

baseline data to enable a
communication strategy to be designed and implemented.

For a successful communication strategy to get public partipation and
awareness in biotechnology, careful planning must be done on these:

: to create awareness? To ens
ure that GMO products are safe

The target groups


the intermediaries and end users

government officials

village officials

school children

The communication channels

mass media, newspapers,
magazines, television, radio, internet, expo
sitions, billboards, bus

On communication channels, Malaysia comes strong with electronic
media and the internet. The latter is particularly timely because the
government has launched successfully ‘one house one computer’
campaign. The figures in ap
pendix 1 show the availability and accesss
of channels in Malaysia.


Malaysia like other countries is looking at biotechnology as one
possible answer to fulfill the population’s need for food, clothing,
medicines, pharmaceuticals and others. At

the same time there is the
feeling of apprehension that things might go wrong somewhere along
the way. As end users everybody has the right to the right information
at the right time to enable them to make right decisions. The
biotechnology package, there
fore, must come complete with a public
participation and awareness program.