Abroad Report

Status of Biosafety of GMOs

in South East Asia

Ginna G. Geal Consultant, FAO project onUpdating Status of Biotechnology in Developing Countries(FAOBioDec) and adjunct professor,
Development Communication program, Department of Agricultural Extension and Communication, faculty of Agriculture,
Kasetsart University, Bangkok, Thailand.

Abstract
The article presents the status of biosafety regulatory policies and measures of the
different South East Asian countries, namely : Brunei Darussalam, Cambodia, Lao
PDR, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, Timore
Leste, and Vietnam. These countries differ considerably in formulating and
implementing regulatory procedures for biosafety of GMOs. Biosafety regulations
are covered by different ministries of departments using guidelines considered as
soft lawsin combination with existing laws. Labeling is mandatory only in
Indonesia but not in other South East Asian countries. Data on public perception
towards GMOs among these countries is limited and that public perception in the
decision making process is still at a minimum.

Introduction Men have used biotechnology for centuries. The new generations of
biotechnologies have great potential in improving farm productivity making
agricultural production more efficient and cost effective.1) The continued
advances in modern biotechnology, the soaring production of genetically
modified crops, and the ratification of the Cartagena Protocol on Biosafety (CPB)
all point to the increasing need of the countries to possess well-developed
biosafety framework characterized by a range of measures, policies and
procedures for minimizing potential risks that biotechnology may pose to the
environment and human health.2) The further development, testing, and

1) Varma, A. 2005. Status of Research and Development of Agricultural Biotechnology. A

paper presented during the APAARI-FAO High Level Policy Dialogue in Biotechnology
for Food Security and Poverty Alleviation: Opportunities and Challenges. November 7-9,
2005, Rama Gardens Hotel, Bangkok, Thailand..
2) Secretariat to the Convention on Biological Diversity and UNEP, Biosafety and the
Environment , June 2003.p.6. http://www.biodiv.org/doc/presskits/bs/cpbs-unep-cbd-
en.pdf

40 Vol.6_No.04
 Status of Biosafety of GMOs in South East Asia

commercial release of genetically-modified (GM) products must be subjected to

adequate scientific, legal, and institutional controls to protect biodiversity.
Traditionally, the economies of most of the South East Asian countries (Brunei
Darussalam, Cambodia, Lao PDR, Indonesia, Malaysia, Myanmar, Philippines,
Singapore, Thailand, Timor Leste and Vietnam) have relied on agriculture for
centuries. The region is the main exporter of tropical agricultural products while
at the same time an importer of some agricultural raw materials. Countries, in
the region as mentioned are at different stages of GMO research and
development, which consequently lead to differing biosafety measures. Thus, it
is also equally important that biosafety standards and regulations are consistent
across region in view of the growing cross border movement of goods especially
with the implementation of free trade agreements among countries.3)

Harmonization of policies and regulations concerning the biosafety issues and

GMOs need collaboration in building up the region
s science and technology capacity
to support policies of choice.This article presents the status of biosafety regulatory
policies and measures of the different countries in the region. Knowing the
biosafety status of these countries will lead to a better understanding of how well
they harmonize the biosafety regulations while they ensure that adequate measures
are taken to manage the risks deemed acceptable to national policies and priorities.

Status of Biosafety Of the eight South East Asian Countries (Fig. 1), which signed the CPB, six
Regulations and have ratified it (Table 1) with notable absence of the Philippines.4) As a whole,
Legislation Policies the South East Asian nations have adopted nonbinding guidelines which provide
some guidance for biosafety framework5).

3) FAO, 2004. Capacity Building in Biosafety of GM Crops in Asia. Project Brochure. 2003.
4) Convention on Biological Diversity. http://www.biodiv.org/biosafety/signing
list.aspx?sts+rtf&ord+dt
5) A report on theBiosafety Policy Options and Capacity Building Related to Genetically
Modified Organisms in the Food Processing Industry of ASEAN. UNIDO. June 2002. p.1

BIOSAFETY 41
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Table 1 Status of ratification and entry into force of CPB in South East Asia.
Country Signature Ratification Ratification
Brunei Darusalam
Cambodia 7 September 2003 16 December 2003
Indonesia 24 May 2000 3 December 2004 3 March 2005
Lao PDR 3 August 2004 1 November 2004
Malaysia 24 May 2000 24 May 2004 16 December 2003
Myanmar 11 May 2000
Philippines 24 May 2000
Singapore
Thailand 19 November 2004 8 February 2006
Vietnam 21 January 2004 20 April 2004

Fig 1 Map of South East Asia (ASEAN)

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 Status of Biosafety of GMOs in South East Asia

Cambodia
The Cambodias policy on biosafety and biotechnology lies within the
biodiversity policy as outlined in the national biodiversity strategy and action
plan. The policy is a part of the strategic changes in developing the country, i.e.
economic growth, social development, and sustainability. Moreover, the
government has recognized that biosafety is a key factor to promote agriculture
and a cross-cutting issue that might not only affect the national food safety but
that of national biosecurity. As Cambodia is still not capable of developing any
GMO in the near future, the National Biosafety Law, which it has drafted with
the assistance of UNEP-GEF will be used to reduce the risks of imported GMOs
on the conservation and sustainable use of its biological resources and human
health. This draft law contains a subdecree entitledManagement and Control of
Living Modified Organisms
. According to this draft law the GMOs that need to
be regulated when imported into Cambodia include GMOs for contained use,
GMOs for intentional introduction into the environment, and GMOs imported for
direct use as food or feed or for processing. The Cambodian Biosafety Law will
not regulate pharmaceutical GMOs for humans and are addressed by relevant
international agreements and or organization.

Other regulating decrees included in the biosafety law are: a) Phytosanitary

subdecree which will regulate all plant quarantine materials brought or
transported into, exit from, or transit in the territory, and b) Law on the
Management of Quality and Safety Products and Services which will regulate
manufacturing products, goods and services. Monitoring and enforcement will
lie on concerned ministries.6)

6) A country paper presented during the Third Regional Consultation of FAO project on
Capacity Building in Biosafety of GM Crops in Asia. 11-14 November 2005. Bangkok,
Thailand.

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Indonesia
The development and commercialization of GMOs and other products of
modern biotechnologies are covered by several regulatory systems including
importation, biosafety and food safety assessment, releasing varieties (for seeds),
and labeling of package products. Biosafety regulatory measures are covered in
the 1999 joint four ministerial decree (Ministry of Agriculture, Ministry of Estate
Crops and Forestry, State Ministry of Food and Horticulture and Ministry of
Health). This decree, which covers all commodities is an expansion of the earlier
1997 decree which covered only agricultural products. The National Committee
for Biosafety and Food Safety with the support of various technical teams, has
drawn up series of guidelines to evaluate the biosafety of genetic engineering
products, i.e. General Guidelines, Biosafety Assessment for Plants, Food Safety,
Feed Safety and Biosafety Assessment for Microbes. With the ratification of
CPB, the 1999 decree was upgraded to Government Decree # 25 which included
time frame and public consultation mechanism.7)

Monitoring for environment effects are done for the relevant Ministry. The
proponent have responsibilities for the negative effects of the GMOs to the
environment and in mitigating the negative effects. Details of the regulatory
systems could be accessed at www.bch.indonesia.org.

Lao PDR
The regulatory regime for biosafety in Lao PDR is contained in the drafted
National Biosafety Framework which is now for final enactment by the

7) Mulya, K. 2005. Country Report presented at the Workshop on Risk Analysis and Risk
Management of Genetically Modified Crops. Tokyo, Japan

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 Status of Biosafety of GMOs in South East Asia

Government. This National Biosafety Framework (NBF) contains all the

elements stipulated in CPB. This NBF draft contains all regulations and
technical guidelines for implementing the so called Biosafety Law which
encompasses all guidelines, ministerial decrees and regulations covering
laboratory work, field work, and planned release and genetically modified foods.
The said law also contains mechanisms for public awareness, education and
participation and capacity building in biosafety.8)

Malaysia
As a signatory to CBD and having ratified CPB in 2003, the Malaysian
government is committed to establish or maintain means to regulate, manage, or
control risks associated with the use and release of GMOs resulting from
biotechnology. Preceding all other major initiatives in biotechnology and
biosafety, a national advisory body called the Genetic Modification Advisory
Committee (GMAC), bringing together scientists administratively under the
ambit of the National Committee of Biodiversity of the Ministry of Science and
Technology and Environment (MOSTE), GMAC provides technical advice to
MOSTE as well as to private bodies and its members who are scientists from
different research institutions, universities, and government agencies. GMAC
also has a representative from the civil society.

Following its establishment GMAC formulated National Guidelines on Release

of GMOs providing a national framework addressing the release and the use of
GMOs into the environment. Conveniently, the GMOs are regulated using these
guidelines. To strengthen and legalize these regulations, GMAC drafted a

8) NEA.2005. Lao PDR Country Paper presented during the Worskhop on ASEAN and the
Cartagena Protocol on Biosafety: National Biosafety Frameworks (NBF), Regional
Cooperation and Information Sharing. Manila, Philippines. 14-15 May 2004.

BIOSAFETY 45
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biosafety bill which serves to regulate the release, importation, exportation, and
contained use of GMOs and the release of products of such organisms with the
objectives of protecting human, plants, and animal health; the environment and
biological diversity. The bill has already been approved by the cabinet and is now
tabled in the parliament for legislation. This Biosafety Bill will act as the first
point of reference on all matters connected with GMOs.

It will serve as anumbrella actand will include the stationary establishment

of the National Biosafety Board. It contains legal and institutional provisions
tailored to comply with the CPB as well as fulfilling domestic needs on regulating
GMOs. The Bill constitutes the legal and institutional base of the National
Biosafety Framework. Under the Bill, the decision-making and authoritative
Board will consist of members drawn from the various relevant ministries. These
are provisions for others to join to contribute to the Board to reflect the diverse
interest groups in the issues of biosafety and GMOs. The enforcement of various
regulations will still be on a sectoral basis. Respective Ministry will continue using
the already existing regulatory mechanisms such as the Plant Quarantine Act and
Pesticides Act of 1974, among other things. In the absence of enforcement clauses in
the sectoral acts, delegated authority will be prescribed. In general, provisions will
be in Biosafety Bill for NBB to act in the interest of Biosafety .9)

Myanmar
Myanmar still has to draw up a regulatory system specific for GMOs. As a
signatory to CPB, the country is now enacting a law, which is a combination of seed
law to protect the benefits of community and IPR of private investors from seed

9) Kamis, Sariah and Atikah Abdul Kadir Jailani. 2005. Biotechnology with Emphasis on
Risk Assessment and Management. A country paper presented during the Regional
Training Workshop on Risk Assessment and Risk Management of GM Crops, 26-29 July
2005.Tsukuba, Japan.

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 Status of Biosafety of GMOs in South East Asia

companies. The country still has no specific biosafety regulatory measures. The
management of biosafety rests on the hand of the technical subcommittee of the
National Seed Committee chaired by the Ministry of Agriculture and Irrigation.
The NBF is currently being drafted with the assistance of UNEP-GEF.10)

Philippines
The Philippine government
s philosophy cum policy in the use of biotechnology
is thesafe and responsible use of modern biotechnology and its products as one
of the several means to achieve food security, equal access to health services, a
sustainable and safe environment, and industry development(President Gloria
Macapagal Arroyo).11)

There is no existing law directly addressing biosafety in the Philippines.

However, currently in place are administrative measures (regulations) to address
biosafety- related issues based on existing legislative mandates (laws). These
biosafety-related regulations are Executive Order (EO) 430 issued by the
President of the Philippines and DA-AO 08, S. 2000 issued by the Secretary of
the Department of Agriculture.

The EO 430 issued in October 1990 constituted the National Biosafety

Committee of the Philippines (NCBP), a multi-disciplinary, inter-agency
technical advisory body tasked to undertake the study and evaluation of existing
laws, policies and guidelines on biotechnology, and recommend measures for its
effective utilization and prevention of possible pernicious effects on the
environment
. This EO also provided for the issuance of the Philippine Biosafety

10) San Lwin.2004. Status Report on Biodiversity and Biosafety. A country report presented
dueing the Workshop on ASEAN and Cartagena Protocol on Biosafety: National
Biosafety Framework (NBF), Regional Cooperation and Information Sharing.14-15 June
2004.Manila, Philippines.
11) Panganiban, D. 2005. Breaking Grounds for the Seeds of Biotechnology. A country
report presented during APAARI-FAO-GFAR High Level Policy Dialogue on
Biotechnology for Food Security and Poverty Alleviation; Opportunities and Challenges.
7-10 November 2005. Bangkok, Thailand.

BIOSAFETY 47
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Guidelines in 19991 and 1998. The former covers work on genetic engineering as
well as activities requiring importation, transport, and contained use of GMOs.
It also describes normal and institutional biosafety committees (IBCs) criteria for
evaluating work under containment, the required physical and biological
containment as well as disposal procedures of materials used in the experiment.
The second guideline covers Planned Release of GMOs and PHES (plant and
harmful exotic species). The guideline establishes criteria for evaluating the
release of GMOs and PHES into the open environment.

It excludes from its coverage work done in the laboratories and greenhouses;
accidental releases from contained facilities; use of pharmaceutical, processed food,
animal feed, industrial products that are already being regulated, work involving
organisms which result from national reproduction or the use of traditional breeding
practices; and, such other activities the NCBP may in the future adhere to be
excluded. Although NCBP, has broad responsibilities, it has no regulatory function.

The DA-AO 08 S. 2000 was issued to regulateimportation and release into the
environment of any plant or plant product derived from the use of modern
biotechnology. The Order covers the importation or release into the
environment of any plant or plant products, which may pose significant risks to
human health and the environment based on available scientific and technical
information. It provides for the approval process and requirements for field
testing, propagation and commercialization, delisting of regulated articles, and
requirements of importation of regulated articles for direct use as food or feed
for processing. The Order placed the approval process for field testing and

48 Vol.6_No.04
 Status of Biosafety of GMOs in South East Asia

release to the environment under the Bureau of Plant Industry while the
approval for contained use remained under the supervision of NCBP.

The National Biosafety Framework (NBF) was drafted to strengthen the NCBP and
provide for coordinated and integrated framework on biosafety decision-making.
This NBF hopefully will be legislated taking into account biosafety regulations which
have been formulated since 1990 such as EO 430 and DA-AO 08 S. 2000.12)

Singapore
Singapore, an industrialized city state with limited land, imports most of its food
and agricultural products. In the past there seems to be minimal control on the
importation of GMOs. However, with the present outcry on the possible risks by
GMOs to human health and the environment, the concerned authorities have paid
attention in strengthening the regulatory systems for GMO food products.

The regulatory body for biosafety is being centralized at the Agri-Food and Veterinary
Authority of Singapore (AVA). The Genetic Modification Advisory Committee (GMAC)
established in 1994 by AVA and the Agency for Science and Technology Research (A*star)
developed the biosafety guidelines on agriculture- related to GMOs. Predominantly, the
biosafety approval process for research and development at the laboratory level is done at
the institutional level. The field trials are done with researchers in foreign countries,
mostly New Zealand and China. However, the National Bioethics Advisory Panel
regulates research on sensitive issues such as stem cell engineering. Though
Singapore is non-signatory to CPB its Biosafety Guidelines contain certain elements
that address biosafety concerns as promulgated by the Protocol.13)

12) Barron, C. 2005. Transgenic Crops Risk Assessment and Risk Management: Philippine
Experience and Updates. A country report presented during the Regional Training
Workshop on Risk Assessment and Risk Management of GM Crops, 26-29 July 2005.
Tsukuba, Japan.
13) A report on theBiosafety Policy Options and Capacity Building Related to Genetically
Modified Organisms in the Food Processing Industry of ASEAN . UNIDO. June 2002.
p.18.

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Thailand
Thailand is the latest country to ratify the CPB. GMO use and development are
being regulated through the existing 1992 Biosafety Guidelines in Genetic
Engineering and Biotechnology for Laboratory, Field Work and Planned Release.
These guidelines were approved and recommended for implementation on a
voluntary basis by all agencies concerned and involved with genetic engineering
research and development. It is through these available guidelines that all
biosafety work dealing with risk assessment and risk management are made
possible.14) The direct use of GMO as food or food additives is regulated through
Guidelines on Food Safety Assessment of Genetically Modified Foods.15)
Although the existing guidelines could be consideredsoft laws
, their adoption
are not mandatory nor are they legally enforced. This makes the abeyance to
present biosafety guideline voluntary until further enactment is sought and
guidelines declared mandatory. While waiting for the finalization and legislation
of the NBF, existing regulatory laws, e.g. Plant Quarantine Act 1964, FDA Act,
etc could be utilized to compliment the enforcement of the biosafety guidelines
whenever necessary.16)

Vietnam
Vietnam has ratified the CPB in January 2005 and has drafted the Decree on
Biosafety Regulations for GMOs. This decree is awaiting government approval.
Pending legislation of this decree, the Government of Vietnam has officially imposed
ban feed or processing. All imported/exported plants and products of the
agriculture-forestry have to pass safety check conducted by the National Plant
Quarantine System. Recently, a National Biosafety Committee composed of
members from six ministries (Ministry of Natural and Environment, Ministry of

14) Napompeth, B. and C. Kongsawat.2004. National Biosafety Framework (NBF) in

Thailand. A country report presented during the Worskhop on ASEAN and the
Cartagena Protocol on Biosafety: National Biosafety Frameworks (NBF), Regional
Cooperation and Information Sharing. Manila, Philippines. 14-15 May 2004.
15) BIOTEC. 2001. Guideline in Safety Assessment of Genetically Modified Foods. National
Center for Genetic Engineering and Biotechnology (BIOTEC). Bangkok, Thailand . 25pp.
16) Napompeth, B. and C. Kongsawat.2004. National Biosafety Framework (NBF) in
Thailand. A country report presented during the Worskhop on ASEAN and the
Cartagena Protocol on Biosafety: National Biosafety Frameworks (NBF), Regional
Cooperation and Information Sharing. Manila, Philippines. 14-15 May 2004.

50 Vol.6_No.04
 Status of Biosafety of GMOs in South East Asia

Agriculture and Rural Development, Ministry of Aquaculture, Ministry of Science

and Technology, Ministry of Public Health, Ministry of Trade) was created. This
committee is responsible for the development of guidelines concerning Biosafety.17)

Table 2 Regulatory systems for Biosafety of GMOs in Southeast Asia.

Country Regulatory System

Brunei In the process of developing biosafety regulations

Cambodia Has a draft biosafety law
Lao PDR Has a draft national policy
Indonesia Guidelines for genetic engineering research 1993;Four ministerial decree, 1999
Draft of presidential decree under preparation

Malaysia Biosafety bill is awaiting enactment by the parliament

Myanmar In the process of developing biosafety guidelines
Philippines EO 430 NCBP guidelines for GM greenhouse experiments
DA-AO 08 S. 2000- regulation on the import, field testing and
propagation of GM plants and plant products
Singapore Singapore Guidelines on the release of agriculture related GMOs
Thailand Biosafety guidelines in Genetic Engineering and Biotechnology for Laboratory Work
Biotechnology guidelines in Genetic Engineering and Biotehcnology for Field Work and
Planned Release
Vietnam Has a draft national policy

Approval Status of Realizing the enormous potential of the application of biotechnology, various
GMOs countries in the Asia-Pacific region have identified biotechnology as a priority
for sustainable growth in agriculture. Some of these countries, have made
dramatic progress in the application of biotechnology for improving crop
productivity and are grouped among the biotech mega countries.18)

17) Vietnam Country Report presented during the Regional Training Workshop on Risk
Assessment and Risk Management of GM Crops, 26-29 July 2005. Tsukuba, Japan.
18) James, C. 2004. Preview: Global status of commercial Biotech GM crops. 2004 ISAAA
Briefs.

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Presently, only two countries (Philippines and Indonesia) have approved

commercial planting of GM crops. Of these two, the Philippines has already been
grouped among the mega countries which grow more than 0.05 million hectares
under commercial transgenic crops. To date the Philippines has granted
approval to three transformation events in corn (Table 3).19) Indonesia, on the
other hand, granted approval for limited commercialization of Bt cotton which
was later discontinued due to economic reasons. The other countries in the
region such as Malaysia, Vietnam, and Thailand have approved the contained
field trials of some crops. Malaysia has approved the confined release of locally
transgenic oil palm tolerant to herbicide Glufosinate Ammonium. Roundup Ready
soybean was approved for release to Malaysia for food and feed use. At present
these four types of GM corn for food and feed (Roundup Ready Corn Event
NK603, Roundup Ready Corn Event GA21,Yieldgard Corn Borer Event Mon 810,
Yieldgard Rootworm Corn Event Mon 863) are awaiting approval from GMAC.

Table 3 Transformation events in corn approved for commercialization.

Transformation Signature Signature Signature
Event

MON 810 Resistance to corn borer Cry 1 A(B) gene Monsanto Dec 2, 2002
from Bacillus thuringienses

NK 603 Glyphosate tolerance imparted by the Monsanto Feb 8, 2005

CP4EPSPS

Bt 11 Insect protected, herbicide tolerance Syngenta Apr 14, 2005

Bt tolerance from Bacillus thuriengensis
and PAT protein from Streptomyces
viridochromogenes

19) Barron, C. 2005. Transgenic Crops Risk Assessment and Risk Management: Philippine
Experience and Updates. A country report presented during the Regional Training
Workshop on Risk Assessment and Risk Management of GM Crops, 26-29 July 2005.
Tsukuba, Japan.

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Vietnam has developed several transgenic crops including vegetables, cereals,

root crops and fruits. However, they are still at the greenhouse awaiting
issuance of official biosafety regulations. Some of GM plants and seeds (corn,
soybean, cotton and rice) are unofficially brought to and grown in fields of many
provinces. Some foods and a lot of animal feeds (milled soybean and maize
grains) areofficiallyimported.20)

Since the Thai government has a liberal policy for research and development
using gene technology, development of transgenic plants for quality
improvement, tolerance to abiotic stresses and resistance to pests and diseases
has been accorded high priority. Thailand has a long experience with the field
traits of genetically modified crops, starting in 1994 and Bt cotton in 1995.21) The
Food and Drug Administration has granted approval for the use of transgenic
soybean and corn as human food and animal feed. The absence of legislated NBF
and the strong lobby from anti GM NGOs, Thailand has adopted a precautionary
approach and still has to approve any commercial production and or release of
GM crop. Transgenic papaya with PRSV resistant gene is probably closest to
commercial release but the country
s ban on commercialization of GMOs has
stunted further commercial development of the crop.

The two countries in the region ever granted approval for commercial release of
transgenic crops or GMOs follow the following approval framework (Fig. 2 and 3).

20) Vietnam Country Report presented during the Regional Training Workshop on Risk
Assessment and Risk Management of GM Crops, 26-29 July 2005. Tsukuba, Japan.
21) A report on the Biosafety Policy Options and Capacity Building Related to Genetically
Modified Organisms in the Food Processing Industry of ASEAN
. UNIDO. June 2002.

BIOSAFETY 53
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Submit: If reg. art. is to be imported:

5 copies of Application Form Certification from country of import

Support documents (technical
dossier; copy of PIS; & BPI
certification that reg. art. has
undergone satisfactory field
testing in the Philippines
that reg. art. is of similar
transformation event approved
locally;
Notification from country of import
in accordance w/ existing
international agreements on GMOs

Applicant
60 day
grace
period to APPROVED
correct 90 day period
defects
BPI
DENIED
5 day
process/
evaluation
period
Evaluation and
risk assessment
STRP
NO YES In allinstances
Sufficient in
Form & BAFPS
Substance? If pest-protected 30 day
plant period
FPA

If intended as feed
BAL
For conduct of
public consultation
Applicant

Shall publish PIS in 2 papers, & invite

comments w/in 30-day pd.

Fig. 2 Application and approval process to release for propagation of GM crop in the
Philippines22)

22) Barron, C. 2005. Transgenic Crops Risk Assessment and Risk Management: Philippine
Experience and Updates. A country report presented during the Regional Training
Workshop on Risk Assessment and Risk Management of GM Crops, 26-29 July 2005.
Tsukuba, Japan.

54 Vol.6_No.04
 Status of Biosafety of GMOs in South East Asia

Proponent

Decree

Ministers*
through relevant
DG

Recommendations

Nat. Com Biosafety & Public

Biosafety Clearing
House

Technical Team for

Biosafety

Fig. 3 Application and approval process for release of GM crops in Indonesia23)

Status of GMO Labeling The debate over food from GM crops often touches on the subject of labeling.
Many consumers argue and insist that it is their right to know what they are
consuming and their right to choose. Consumers say it all the timewhy not
label these foods if you are sure of their biosafety?or that consumers should
have a choice on what to eat
. As a result many governments have began to
heed these suggestions and have either implemented labeling regulations or are
working on them.

23) Subagyo, T. 2204. National Biosafety Framework in Indonesia. A country paper

presented during the Worskhop on ASEAN and the Cartagena Protocol on Biosafety:
National Biosafety Frameworks (NBF), Regional Cooperation and Information Sharing.
Manila, Philippines. 14-15 May 2004.

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The issue of labeling is not all simple as the questions posed by the consumers,
especially if the starting point of labeling includes the process rather than the final
product. Issues such as safety, cost, truth in advertising, choice, fairness, science,
trade barriers, regulatory responsibility, accountability, legal liability, among others
are component of the process. Testing of the presence of GM ingredients and the
subsequent costs should be clearly implemented. Labeling for GM product in
Indonesia is mandatory as described by Law Food number 7 1996 article 13 (1) and
Government Decree 69 1996 of Food Labeling and Promotion article 35 .

In Malaysia, food labeling is contained in the draft amendment of the Food

Regulations of 1985. GM food need not be equivalent to the corresponding
existing food and food ingredients are required to be labeled. The label must
provide information in the characteristics or properties, i.e. component and or
nutritional values and intended use, making it different from the corresponding
existing food and food ingredients.Information on mode of storage and
preparation or cooking should be on the label. The threshold level is determined
to be more than 3% of the total ingredient.24)

Mandatory labeling is stipulated in the House Bill 1647 filed in the Philippine
Congress in 2001. This Bill is still under consideration. Thus, the Philippines has
no labeling law until the passage of this Bill. The regulatory systems governing
commercialization of transgenic crop do not cover labeling.

There are also no labeling provisions for GM food in Singapore to date. GMAC
is waiting for the international agreement on the issue.

24) A report on theBiosafety Policy Options and Capacity Building Related to Genetically
Modified Organisms in the Food Processing Industry of ASEAN . UNIDO. June 2002.

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The Food and Drug Administration of Thailand has formulated a labeling

regulator for food containing ingredients derived from GMO. The threshold level
has been determined to be 5% of the top three ingredients.25)

Public Perception The Asian Food Information Center (AFIC) market studies conducted in some
South East Asian countries (Thailand, Philippines, and Malaysia) in 1998-1999
showed that the public in general was not aware of biotechnology nor of GMO in
general. In Thailand, 12% of the respondents werevery quiteaware, 38% in
the Philippines and 8% in Malaysia and Indonesia. The responses to the question
ofordinary soybeans don
t contain genes but GM soybeans doalso indicated
limited knowledge in biotechnology in all five countries where more than 50%
answered eitheryesordon .26)
t know

The most recent consumer survey conducted by the same organization in

China, Indonesia, and the Philippines suggested that 2/3 of the consumers not
only accepted GM foods but also believed that they would personally benefit from
consuming GM foods consistent with previous observations.

A specific survey of the perception, understanding, and acceptance of GMO in

Thailand found the following: a) people of higher education have better
understanding and knowledge of biotechnology; b) Breeding methods did not
affect peoplesperception in choice of crop breeding do not affect peopleschoice
of crop/breed variety; c) Presence or absence of biotechnology was not a criteria

25) Napompeth, B. 2004. Current Biosafety Policy and Regulation in Thailand. A handout.
26) http:// www.isaaa.org/kc/Publications/htm/docabinets/survey.htm

BIOSAFETY 57
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for consumers choice of processed food; d) people of higher education had more
fears towards effect of GMOs on health while those of lower education were more
neutral. Peoplesmain concern was the lack of government clear cut policy on
direction regarding GMOs as well as the lack of information, data and solid
scientific proof.27)

There are no available documents as to the perception of the public towards

GMOs in other Southeast Asian countries where biotechnology is still in its
infancy. Most countries do not have structured or organized public education
program on GMO. This is in contrast to the programs and organized campaigns
of anti-GMO NGO groups. This is the reason why negative perception or
ignorance of real issues on GMOs prevails.

In terms of education campaign, many countries in the region have a built-in

system of public awareness for field trials or commercial release. Some have
public participation in the decision-making level. Indonesia requires the
proponents to announce the plans for use/release of GMOs in local newspapers
upon submission of application or upon receiving directives from the Ministry of
Agriculture. Malaysia requires that national authorities, industry, and
researchers disclose or make available safety information to the public
particularly to the communities where field trials or planting to take place. In
Malaysia, GMAC must inform the local community of planned release and
national authorities should provide appropriate information to the public. The
Philippines has a similar but more public involvement such that, there must be
two community representatives in NCBP and in IBCs and public information

27) http://www.afic.org.survey??

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 Status of Biosafety of GMOs in South East Asia

sheet (PIS) must be posted in target field test site and allow 30 days for public
comment. In addition, announcement is also made on the first two most
popular national dailies. Thailand has a member of civil society and industrial
representatives in the policy-making body of NBC. Singapore also has a
consumer group in GMAC and decision to inform the public of planned release of
GMO is rested with GMAC.

Summary / Conclusion The countries in the South East Asian region differ considerably in their status
of formulating and implementing regulatory mechanisms to ensure biosafety of
GMOs. These countries mostly lack unified biosafety regulatory system, which is
covered by the different ministries and departments. A single window system,
for the efficient utilization of GMOs has not been developed in most of the
countries. This calls for an urgent need of putting in place biosafety mechanisms
and develop an efficient system for risk assessment and risk management.
Irrespective of diversity of the countries, the regulatory measures related to
biosafety would have considerable common features. Harmonization of biosafety
procedures will be useful for ensuring safety and efficient implementation of
regulatory mechanisms. It would also lead to consensus documentation related
to biosafety evaluation of GMOs, which would be valuable in thelong term
.

Majority of the South East Asian countries use guidelines, which could be
considered soft laws combined with existing regulatory to ensure safety
utilization of GMOs and mitigate potential risks to the environment and human
health. Indonesia and the Philippines regulate GMOs through administrative
order and or ministerial decree or joint ministerial decree. Indonesia has the

BIOSAFETY 59
 Abroad Report

Food Safety Bill to regulate the direct utilization of GMOs for food or feed. A few
countries such as Vietnam, Cambodia, and Lao PDR are in the process of
preparing legislation or House Bill. The Malaysian House Bill for Biosafety has
been tabled for legislation by the parliament. Singapore, Philippines, Thailand,
Indonesia and Malaysia have clear time-frame in their draft NBF. Biosafety
decree of the Philippines is the most complete and detailed. However, this
involves a lot of administrative work and is limited to plant products only. The
Philippinesdecision making involves many experts, from various institutions for
risk assessment and the permit is only valid for a certain period. Both Thailand
and the Philippines have IBCs responsible for the safety of GMO research.
Indonesia
s NBF has a clause on ethics. In terms of the composition of the
Biosafety Committee, different countries have different policies (based on
expertise or ex-officio of line ministries, agencies and public representative.

Labeling is mandatory in Indonesia since 1999, however, implementing regulations

have yet to be formulated. Thailand has a liberalized labeling regulations. Malaysia
and the Philippines are in the process of developing GMO labeling policy.
There is very limited data on public perception towards GMOs among the South
East Asian countries. Few studies conducted indicated limited public knowledge
of GMOs in the region and attitude leans towards the negative. The prolific
anti-GM campaigns by the NGOs have somewhat contributed to the existing and
somewhat negative public perception. It is apparent that misinformation and
lack of scientific understanding lead to poor judgment. Generally, public
perception in the decision making process is still minimum.

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