Biosafety- Risk assessment and Management

Slamet-Loedin, Inez H.
Research Center for Biotechnology-Indonesian Institute of Sciences (LIPI)

Biosafety Status and National Biosafety Framework
National Agricultural Research System/Institutes
Capacity development
Capacity Building
Regional Cooperation mechanism and recommendations

I. Introduction

The Indonesian archipelago, situated in the tropic with total land area of 1.919 m. square km and comprise 17508 islands, represent one of the megadiversity countries together with Brazil and Zaire. Indonesia is a party of Convention of Biological Diversity as stated in Indonesian Law no 5/1994 for the ratification of UN Convention on Biological Diversity. Indonesia now is the world's fourth largest country in population and value of agriculture as % of GDP is 13%. Agriculture plays a substantial role in Indonesian economy, involving more than 55% of the population, 19% of the gross domestic product (GDP) and more than 60% of the value of non-oil exports. Over the last two decades annual agricultural output has grown by 4%. Rice production accounts for more than 40% of agricultural output, land use and employment (Dart et al., 2002). Production increased from 12 million t in 1969 to 44 million t in 1991, decreasing to 39.9 million t in 2001 (Indonesian statistics) mainly due to the land conversion. A similarly dramatic increase occurred in livestock production including fish and eggs, from 2.2 million t in 1974 to 4.3 million t in 1987, a 52% increase. As one of the mega centers of biodiversity countries, Indonesia would like to utilize its diversities of our natural resources in sustainable manner as one of the modalities and comparative advantages to develop biotechnology. Indonesia has placed a high priority on the development of biotechnology since 1985 to address the need for sufficient food production in a more sustainable precision agriculture system. A national committee for biotechnology was established at the same year at the State Ministry for Science and Technology Sasson, 1993) to prepare and formulate policies and programs for the national development for biotechnology. In order to Implement the research priorities and policies, State Ministry of Science and Technology has designated four national centers, those are the two centers of excellence for agriculture and two other centers for industrial and medical biotechnology. The major players of agriculture related biotechnology research in Indonesia is research centers under Ministry of Agriculture, non-ministerial governmental research organizations coordinated by State Ministry of Research and Technology, and universities. Plant transformation programs are now being carried out at public and semi public research institutes, a public university and an industrial laboratory. RCBt, RIFCB (Research Center for Food Crop Biotechnology-CRIFC, Bogor Agricultural University (BAU), all are public research institutes or university located in Bogor, have programs on plant transformation. The two semi public research institutes working in this area are BRUEC (Biotechnology Unit for Estate Crops) located also in Bogor and ISRI (Indonesian Sugar Research Institute) located in Pasuruan, East Java. Appendix 2 shows the overview of research status of transformation program in Indonesia. The only industrial research institute carried out research in this aspect is the Indah Kiat research center in Pekanbaru-Riau focusing on forestry plants (Slamet-Loedin et al., 2000). Animal transformation project has been initiated this year in RCBt-LIPI.
After the economic crisis in 1998, the focus of biotechnology research has been redirected to immediate application of existing biotechnology technique for product(s) manufacture aimed to response to the needs of the people, especially in food production, production of traditional medicine and added value of agricultural products for export production as the first priority. For the long term priority, the strategic research and capacity building were aimed to response to the rapid global development of biotechnology to improve national capabilities in this field.
Immediate application of an existing technology in agriculture biotechnology was elucidated as the application of transfer of cattle embryo to increase and improve cattle population to response the demand of meat and milk, improvement of the production of staple foods including rice and soybean, production of raw material for drug and traditional medicine, embryo transfer and diagnostics kit for animal diseases, biofertilizer and biopesticides.
Strategic research is aimed at a competitive position of Indonesia in the global market. Strategic research program should be based on competitive advantages of the country in biological diversity. Drugs discovery projects, genomics, conservation of germ plasm, genetic improvement of agriculture commodities (food crops, horticulture, fruits, animal husbandry etc.), marine biotechnology and environmental biotechnology (bio-remediation) are projects planned to be undertaken in this field.

to the top

II. Biosafety Status and National Biosafety Framework

Indonesian is the signing member of Cartagena protocol. The focal point of the Protocol is the Ministry of Environment, while Competent National authorities are the Department of Agriculture and Food and Drug Agency. Indonesian Institute of Sciences was assigned as the focal point for Biosafety Clearing House. Indonesia is the first country in Southeast Asia to venture into the environmental release of genetically engineered crop, that is the Monsanto Bt cotton, after having done the risk assessment in form of glass house trial, limited field release and multi location trials prior to the released. The released was limited for one year for seven districts in South Sulawesi and has been extended for the second year based on the results of environmental risk analysis in the field.
In August 1993, the State Ministry on research and Technology released a guideline on genetic engineering research. The emphasis of this guideline is for the control of research of genetically modified organisms. Indonesian biosafety regulations for release of GMO were put in place in 1997. The Minister of Agriculture released a Ministerial Decree for Genetically Engineered Agricultural Biotechnology Product in 1997. To implement the decree, a Biosafety Commission was formed in 1997 with a mandate to advice the government on the safe release of agriculture biotechnology product to the human health and/or environment. A biosafety technical team consisting of experts in agricultural biotechnology representing different national institutes and universities was formed to assist the commission to evaluate the application and carry out technical study and test the genetically engineered biotechnology product in a biosafety containment or confined field. This technical team formulated a series of guidelines for released of genetically engineered organism. The guidelines include the general one for plant, cattle, fish and microbes and specific guidelines for each item.
The 1997 decree did not cover the food safety. To fulfill this need, another decree was released in 1999 as a collective decree of four ministries (Ministry of Agriculture, Ministry of Estate crop and forestry, Ministry of Food, Ministry of Health) for biosafety and food safety of Genetically Engineered Agricultural Biotechnology Product (Herman, 2000). The committee member and technical team members were also expanded representing different parties. The guidelines of food safety of GMO products have been drafted. After applications are reviewed and accepted by the National Biosafety Committee for contained and limited field trial and passed the biosafety status then it has to go to the Plant Variety Release Committee for multi location field trials with monitoring of the Biosafety Committee.
At present the government is preparing an improved national biosafety framework in form of presidential decree or law. According to the food safety law (UU no.7, 1996) and the regulations, labeling of genetically engineered food is mandatory since 1999, but due to several reasons it has not been implemented yet.
Indonesia has commercially released Bt cotton from Monsanto, although limited to certain areas in southern Sulawesi for the second period of one year. The second year extention was given based on the results environmental risk analysis includes study on non-target insects, impact to soil microbes and gene flow. Several applications have been reviewed by the technical team and the Biosafety Comission. These include the Monsanto Roundup ready soybean, Roundup ready and Bt cotton, Roundup ready and Bt Corn, and Pioneer Bt. Confined field trial has been done for the transgenic RR and Bt cotton, RR soybean and RR and Bt corn from Monsanto.

to the top

III. National Agricultural Research System/Institutes

Agricultural biotechnology research and development in Indonesia are largely financed and undertaken by the public sector. Ministry of Agriculture, State Ministry of Research and Technology, non-ministerial government organizations and universities are the major actors in agricultural research.
The Ministry of agriculture has several research institutions involves in research and development under its Agency for Agricultural Research and Development (AARD). There are at least 8 research institutes under AARD related to biotechnology. Those are the Central Research Institute for plantation (estate) Crops, Bogor and Marihat Medan, Central Research Institute Industrial Crops, Bogor, Indonesian Sugar Research Institute, Pasuruan, Research Institute for Animal Production, Ciawi, Bogor, Research Institute for Animal Diseases (Balitvet), Bogor, Central Research Institute for Freshwater Fisheries, Jakarta (Gumbira Said, 2001).
In 1985 the state Minister of research and technology designated four national centers of excellence for agriculture, industrial and medical biotechnology. The centers of excellence on Agricultural Biotechnology I and II are the Central Research Institute for Food Crop Biotechnology-AARD and Research Center for Biotechnology-Indonesian Institute of Sciences/ of LIPI (formerly R&D Center for Biotechnology), both located in Bogor. The other centers of excellence are the Medical faculty, University of Indonesia in Jakarta and Eijkmann Institute for medical biotechnology in Jakarta and Agency for Technology Assessment and Application (BPPT) for industrial biotechnology in Jakarta. The later one also conducts activities related to agriculture biotechnology. Indonesian Institute of Sciences and the Agency for Technology Assessment and Application (BPPT) are both non-ministerial government bodies responsible to the Head of Government, but the activities are coordinated by the Ministry of Science and Technology.
In addition to that, the government of Indonesia established Inter University Centers in Bogor Agricultural University, Bandung Institute of Technology and Gajah Mada University in Jogjakarta focusing on agriculture biotechnology, industrial and medical biotechnology respectively. These centers are attached to the universities as part of university network for the development of education. At present however, they have become research centers under different names, they also play an important roles in the development of agricultural biotechnology in Indonesia in their respective area. Department of Forestry has also research centers working in forest biotechnology.
The funding for research comes from internal and external resources. The government launched several funding schemes such as the Integrated Supreme Research (RUT) grant program in 1992, Joint Supreme Research (RUK), Competitive grant for universities (Hibah bersaing), the International integrated competitive joint research (RUTI) in 2002 to accelerate the development of biotechnology. The priorities of research are formulated by National Research Council, while the selection of the proposals are conducted by panel experts set by NRC and universities in the case of competitive grant. The panel of experts will advice the National Planning Board and Ministry of Finance to fund recommended proposals. External Funding such as funding from Agricultural Research Management/ARM (World Bank Loan), USAID, The Rockefeller Foundation, Winrock International, ACIAR, INCO-European projects, Japan International Cooperation Agency have plays an important role in the development of agricultural research, although mainly in the initial development of biotechnology such as building infra-structure and man power development.

to the top

IV. Capacity development

From 1989-1997, the number of researcher has almost tripled, MSc and BSc holder from 75 to 247, while researcher holding the PhD degree increased by almost 2 times from 50 to 102 (Falconi, 1999) and has been increased more. However, researchers in the field of plant molecular biology are still scattered in different institutions. This group of professionals become the basis for the development of agriculture biotechnology advances in the future, and 96% of them are working in the public sector. About 60% of the researchers are located in three research organizations, which belong to the public sector: RIFCB, RCB-IIS, and IUC.
The capacity development related to biosafety is summarized in Table 1.

Existing Capacities Capacities needed Risk Assessment · Capacity to analyze application data related to molecular biology, entomology and breeding are available, but knowledge can be improved.· The expertise is stronger in plant science compares to animal science.· Capacity for food safety assessment are not sufficient · Ecologists aware with this topic and related aspects are needed.· Number of trained entomologist capable to handle this topic needs to be increased.· Information on risk assessment strategy in similar region is required (not only summary of risk assessment as minimally required in the protocol)· Food safety assessment knowledge needs to be improved Risk Management · Very little · Knowledge needs to be improved· Strategy needs to formulated

Legal issue · Moderate · Knowledge improvement in liability issue is required
Communication issue · A few number of scientists dealt with this matter· Information in the media is imbalanced between the pros and cons · Public awareness and risk communication technique needs to be improved· Capacity to convey issue of risk management to the farmers is needed

to the top

V. Capacity Building

Man-power development to build a critical mass for different aspects of biotechnology and launching a more structured public awareness programs to increase public knowledge in risk and benefit of biotechnology; improvement of institutions and coordination framework, creation of a conducive scientific environment have been recommended to improve and promote development of biotechnology in Indonesia in the 2001 draft for policy strategies. Promote involvement of private sector through development of industrial area for biotechnology (bio-island concept), establishment of incubator technology and a special investment policy are also recommended.
Specific training in risk assessment and management for the the technical persons are required. The general training has been carried out several times, which is more needed is a specific training in carrying out the risk assessment on several biosafety issues. The quarantine people needs training to handle the importation of GMO.
Indonesia has already a form legal framework for biosafety in form of Ministrial decrees, but it needs to be improved to include participation of all stakeholders and to form a more legally bind regulations in form of law or at the least precedential decree. The proposal on development of national biosafety framework has just been accepted by UNEP-GEF project and will be implemented in the next 18 months. ICCP/COP-MOP can form a complete guidelines for risk assessment and management and published it as books.

to the top

VI. Regional Cooperation mechanism and recommendations

There are various areas that regional cooperation is needed. Among the areas or the topics that regional cooperation needs to be sthrengthened are as follows:
· Sharing information for risk assessment in the similar ecological region would be very useful for countries to carry out their own risk assessment. This sharing information can be done through the national biosafety clearing house.

· Disseminating information of biotechnology products and breakthrough in research and development

· Regional effort on capacity building for risk assessment and management in specific topic of environmental and food safety issues in form of training, modules and publications

· Regional effort on capacity building for data management and biosafety website development

· Regional effort on capacity building for developing national biosafety framework

· Regional effort on capacity building for quarantine people.

· Strategy formulation for risk management for specific GM crops.

· Harmonization of the biosafety regulations in form of dialogue in the policy level.

· Public awareness approach to sthrengthen public confidence in biotechnology

· Cooperation in research and development in various areas of biotechnology, particularly genomics, trancriptomics and proteomics for global competitiveness.

· Cooperation in carrying out R&D related to environmental impact and food safety issue of genetically engineered agricultural products and foods.

At national level formulation of balanced and legally bind national biosafety framework is very important. Capacity building for biotechnology in general and risk assessment and management issues is needed. A formulation of national strategy on biotechnology is vey important. Human resource development to build a critical mass for different aspects of biotechnology and launching a more structured public awareness programs to increase public knowledge in risk and benefit of biotechnology; improvement of institutions and coordination framework, creation of a conducive scientific environment are the responsibility at national level.
At sub- regional and regional level a joint effort in capacity building in various aspects mentioned above can be conducted. Cooperation in R&D level in various aspects of biotechnology including risk assessment and management strategies would be very beneficial. Development of internet basis for information sharing inside the region regarding regulatory matters, risk assessment and analysis and research development would be needed. This would assist countries in the same regions to make decision on environmental release of GM organism and products and to counteract misinformation by providing a scientifically based information and to assist country to develop assessment methods, detection methods and risk management and monitoring strategies.

to the top


Collective Decree of Ministry of Agriculture, Ministry of estate crop and forestry, Ministry of health, Ministry of food No 998.1/Kpts/OT.210/9/99; 790.a/Kpts-IX/1999; 1145A/MENKES/SKB/IX/199; 015A/Nmeneg PHOR/09/1999.
Dart, P.J., I.H. Slamet-Loedin and E.Sukara. 2002. Indonesia. In agricultural Biotechnology: Country Case Studies- A Decade of Development. Persley G.J. and L.R. Maclntyre (eds.). Biotechnology in agriculture series No. 25. CABI Pbls.
Falconi C.A. 1999. Agricultural Biotechnology Research Capacity in Four Developing Countries. ISNAR Briefing Paper 42.
Gumbira said, E. 2001. The State of Indonesian Biotechnology. Australian Biotechnology. 10(4). P: 29-32
Herman M. 2000. Genetically Engineered Plant and Biosafety Regulation in Indonesia. Journal Agribio.
Loedin, A.A. 1991. Public Policies to Promote National Capabilities in Biotechnology. In Biotechnology for Asian Agriculture: Public Policy Implications. I.P. Getubig; V.L. Chopra; M.S. Swaminathan (eds.). Asian and Pacific Development Center. Kuala Lumpur.
Ministrial Decree from Department of Agriculture No: 856/Kpts/HK.330/9/1997.
MNLH. 1993. Indonesian Country Study on Biological Diversity. Ministry of State for Population and Environment.
Moeljopawiro, S. and Cesar Falconi. 1999. Agricultural Biotechnology Research Indicators: Indonesia. Discussion paper No. 99-07 April 1999. ISNAR/The Netherlands
Saono.S. 1995. Biotechnology in the Member States of Asean. Biotechnology 12: 409-417.
Sasson, A. 1993. Biotechnologies in Developing Countries: Present and Future. Vol. 1: Regional and National Survey. Unesco Publishing. Paris.
Slamet-Loedin, I.H., Toruan-Mathius, N., Sukara E., and Karossi A.T. 2000. Status of R&D on transgenic plants in Indonesia. Paper presented in ASEAN-China Workshop on Transgenic Plants, Beijing, China.
Sukara E. and Soetisns U. 1999. An overview on The Recent Indonesian Biotechnology Development Policy. Paper presented at "Network for Scientific Cooperation in Biotechnology. Bangkok.
Zuhal. 2000. Pengembangan Bioteknologi dalam Menyongsong Millennium Ketiga. State of Ministry of Research and Technology.

Appendix 1. List of Agricultural Biotechnology Research Institutes

The following is the list of institutions engaged in agricultural biotechnology research in Indonesia

Name, Address Status Areas of Activity

Centre for the Assessment and Public Agricultural Biotechnology
Application and Agricultural Animal Biotechnology
Biotechnology-BPPT Forestry Biotechnology
BPP Teknologi Building 10th Floor Industrial Biotechnology
Jl.M.H.Thamrin 8
Jakarta Pusat,Indonesia

Research Institute for Food Crops Public Agricultural Biotechnology
Jl. Tentara Pelajar 3A
Bogor 16111, Indonesia

Research Centre for Biotechnology Public Agricultural Biotechnology
Indonesian Institute of Sciences Animal Biotechnology
Jl. Raya Bogor Km 46 . Cibinong 16911. Forestry Biotechnology
Industrial Biotechnology

Research Institute for Animal Public Agricultural Biotechnology
Production Animal Biotechnology
Balai Penelitian Ternak Industrial Biotechnology
P.O.Box 221
Bogor 16002, Indonesia

Research Institute for Veterinary Public Veterinary Biotechnology
Jl. R.E. Martadinata 30
P.O.Box 52 Bogor 16114

Biotechnology Research Unit for Public Agricultural Biotechnology
Estate Crops
Jl. Taman Kencana No.1
Bogor 16151, Indonesia

Inter University Centre (IUC) on Public Industrial Biotechnology
Institut Teknologi Bandung
Jl. Ganesha 10
Bandung 40132, Indonesia

Faculty of Animal Science PublicUniversity Animal Biotechnology
Diponegoro University
Jl. Hayam Wuruk 4-A
Semarang, Indonesia

Laboratory of Biotechnology Public University Agricultural Biotechnology
Department of Biotechnology Industrial Biotechnology
Faculty of Science and Mathematics
Diponegoro University
Faculty of Science and Mathematics
University of Diponegoro
Tembalang Campus
Semarang, Indonesia

Faculty of Agriculture PublicUniversity Agricultural Biotechnology
Sebelas Maret University
Jl. Ir. Sutami no. 36A
Kentingan, Surakarta, Indonesia

Faculty of Biotechnology Public University Industrial Biotechnology
Jendral Soedirman University
P.O.Box 30
Purwokerto, Indonesia

Faculty of Agriculture Public Universiry Agricultural Biotechnology
Gajah Mada University
Sekip Unit I, P.O.Box I
Yogyakarta 55281, Indonesia

Faculty of Biology Public University Agricultural Biotechnology
Gajah Mada University Animal Biotechnology
Jl. Teknika Selatan, Medical Biotechnology
Bulak Sumur,
Yogyakarta, Indonesia

Food and Nutrition Development Public Agricultural Biotechnology
and Research Centre (FANDARC) Animal Biotechnology
Teknika Utara, Barek Yogyakarta Industrial Biotechnology

Inter University Centre for Public University Agricultural Biotechnology
Biotechnology (IUC-Biotechnology) Animal Biotechnology
Gajah Mada University Industrial Biotechnology
Jl. Teknika Utara, Barek Medical Biotechnology
Yogyakarta, Indonesia

Faculty of Pharmacy Public University Agricultural Biotechnology
University of Airlangga Animal Biotechnology
Jl. Darmawangsa Dalam Medical Biotechnology
Surabaya 60286, Indonesia

Institute of Teacher Training Public University Agricultural Biotechnology
and Education
Kampus IKIP Ketintang
Surabaya, Indonesia

Faculty of Animal Husbandry Public University Animal Biotechnology
Brawijaya University Industrial Biotechnology
Jl. Majen Haryuono 169
Malang 65415, Indonesia

Industrial Technology Study Public University Agricultural Biotechnology
ProgramAgricultural Technology Industrial Biotechnology
Division Brawijaya University
Jl. Urip Sumohardjo F-3
Malang, Indonesia

Research Institute for Tobacco Public Agricultural Biotechnology
And Fibre Crops (RITFC)
Jl. Raya Karangploso
Malang, Indonesia

P.T. Fitotek Unggul Private Agricultural Biotechnology
Jl. Jampang- karihkil Km 7
Parung, Indonesia

P.T. Monfori Nusantara Private Forestry Biotechnology
Jl. Jampang- karihkil Km 4
Parung, Indonesia

P.T. Indah Kiat Pulp & Paper Coorporation Private Forestry Biotechnology
Jl. Raya Minas-Perawang Km 26
Desa Pinang Sebatang Bengkalis
Riau Indonesia

Yogyakarta Plantation Institute Private Agricultural Biotechnology
Jl. Urip Sumoharjo 100
Yogyakarta 552222, Indonesia

P.T. Foodtech Utama International Private Agricultural Biotechnology
Jl. Ancol I, no 4-5 Ancol Barat Industrial Biotechnology
Jakarta 14430

Appendix 2. Status of Transgenic Research in Indonesia

Crop Institute Target trait Gene
Rice RCBt Resistance to rice stem borer cry and/orsnowdrop lectin
Rice RCBt Blast and drought chitinase , other anti fungal genes and newly explored regulatory genes
Paraserianthes falcataria RCBt Resistance to stem borer pin
Cassava RCBt Starch composition Candidate genes
Rice RIFCB Resistance to rice stem borer cry
Corn RIFCB Resistance to Asian corn borer pin and cry
Sweet potato RIFCB Sweet potato feathery mottle virus coat protein and pin
Soya bean RIFCB Pod borer cry
Peanut BAU Resistance to peanut stripe virus coat protein
Chili pepper BAU Resistance to potato Virus Y coat protein
Potato BAU Resistance to potato Virus Y coat protein
Coffee (Arabica) BRUEC Tolerance to rust chitinase
Cacao BRUEC Stem borer cry
Sugarcane BRUEC, ISRI &Jember Uni. Drought tolerance Candidate genes
Sugarcane ISRI Stem borer cry
Forestry plants INDAH KIAT Insect resistance, agronomic quality n.k
Papaya RIVC & RIFCB Virus resistanceDelayed ripening Coat protein, anti-sense
The abbreviations can be consulted in Appendix 1

to the top