ASEAN AgroBiotechnology: Overview and Recommendation on Regional Collaboration

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ASEAN Agro-Biotechnology Overview and
Recommendation on Regional Collaboration
Sakarindr Bhumiratana and Ruud Valyasevi
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• Established August 8, 1967 in Bangkok (I, M, P,
  S, T)
• Brunei - 84,
• Vietnam -95,
• Laos and Myanmar 97,
• Cambodia 99.
• Population 500 million
• Area 4.5 million sqkm
• GDP US737 billion,
• Total trade US 720 billion.
• Primarily agriculture based.

The Importance of Agriculture
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The Issues
Human rights nutritious food, culturally
acceptable - access to knowledge and
technology - right of informed choice
- right of participation Health safety policy
on regulations - informative labeling
- sufficient research locality? - life
saving potentials Bio-safety concerns -
bioterrorism, environment, loss of biodiversity
- implementation of Cartagena Protocol
- harmonization of standards and protocols
- science based sc to inform and not to
control decision making process -
transparency of SPS and invalidity of
one-size-fit-all approach - regulations at
institution, regional and international levels
- systematic capacity building in science and
law at all levels
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ASEAN - AgBiotechnology

• Have invested much in the development of RD,
  human resources, and infrastructure support for
  biotechnology.
• Many challenges, issues and concerns
• Strategies are to keep biotechnology in a
  balanced perspective in the framework of existing
  national research agendas and priorities.
• Plant transformation, Marker assisted selection
  (RAPD, QTLs..)
• Plants and animals

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Status of Ag-Biotechnology applications in ASEAN

• Capacity building
• Setting up necessary infrastructure to regulate
  and controls the research, commercialization and
  trade of GMO products.
• Few have clearly approved the use of GM food
  crops as human and animal feed,

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Status of Ag-Biotechnology applications in ASEAN

• Few have clearly approved the use of GM food
  crops as human and animal feed,
• All have imported products such as GM-soy,
  GM-maize and processed food-products

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Status of Ag-Biotechnology applications in ASEAN

• Sauces, beverages, tempeh, tofu and soy-bean
  oil, corn oil, flour, starch and oil.
• Maize and soy meal - animal feed.

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GM Crop production

• Indonesia allowed limited (spatial and time)
  production of Bt-Cotton.
• Indonesia, Malaysia, Philippines, Singapore,
  Thailand and Vietnam have conducted limited GMO
  field trials

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GM Crop production

• Crops (being) tested are Bt corn, Bt soybean,
  Roundup Ready Soy, Bt Cotton, Flavor Saver
  Tomato, Viral resistant papaya and tomato from
  local Monsanto, AgroEvo, Pioneer Seeds, Cargill
  Seeds, and Novartis.
• Some cases where requests for field trails were
  turned down.
• No report of field trials in Brunei Darussalam,
  Cambodia, Laos or Myanmar.

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Clear Policy ??

• Singapore Asia Center on Health related
  Bio-industry. Add 7,000 biotech researchers,
  invest 2.5 billion by 2005.
• Japan 1,000 new biotech comp with 217 billion
  investment by 2010
• China to double its 3,000 biotechnology research
  centers in 10-15 years.
• Malaysia - Bio-valley plan, 12 billion in 10
  years. National Biotechnology Directorate to
  spearhead
• Philippines - biotechnology programs in 1979
  National Institutes (BIOTECH) 3 biotech inst
  in95. (PhilRice).
• Thailands BIOTEC of NSTDA. - Science Park.

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ASEAN Ag-biotechnology areas

• GMP
• Bio-control, bio-fertilizers, tissue culture,
  inoculants, plant-microbe interactions,
• Animal biotech (vaccines, diagnostics,
  pro-biotics and feed additives)
• February 02, Embryo technology service company
  was set up in Thailan.

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ASEAN development in biosafety

• Indonesia has clearly stated regulations, but has
  some difficulties implement them.
• Malaysia has drafted a biosafety bill and is in
  the process of having it legislated into law.
• Indonesia and Singapore had developed guidelines
  for labeling of GMO products.
• ASEAN have developed env-safety guidelines
  except for Brunei, Laos, Myanmar and Vietnam.
• Based mainly from UNEP, UNIDO, CBD, MAFF, UK,
  GMAC and FAO guidelines
• To adopt the product-based rather than
  process-based approach for the evaluation of
  GMOs.
• Substantial equivalence - case-by-case basis.

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Table 5. Status of GMO in ASEAN
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Regulatory Policy and Institutional Framework in
ASEAN

• Indonesia, Malaysia, Philippines and Thailand,
  have successfully conducted field trials of GMOs.
• Indonesia is the only country which has approved
  the environmental release of Bt cotton. (7
  districts in South Sulawesi province), the cotton
  seeds are to be exported only and the remaining
  plant parts must be destroyed. Annual renewal.
• Indonesia - completed field trials for soybean
  and corn

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Regulatory Policy and Institutional Framework in
ASEAN

• Thailand - concluded three years of environmental
  studies on Bt cotton, corn, tomato viral
  resistance papaya is being field studied.
• Malaysia - concluded the env-assessment of GM soy
• Philippines - completed field trial of Bt corn
• Singapore - approved commercial sale of GM blue
  cut carnation but not for growing.
• There have been reports of illegal planting of GM
  crops, particularly Bt cotton by farmers in
  Thailand, Vietnam and Indonesia.

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Policy to be developed

• Cambodia, Laos, Myanmar, Brunei and Vietnam.
• Laos is setting up the National Biosafety
  Framework, designated STEA as national focal
  point.
• Brunei is establishing a National Authority on
  Genetic Modification (NAGM) to oversee the
  regulatory control of GMOs.
• Vietnam has formed a working group and drafted
  the Biosafety Bill which is being approved by the
  Ministry of Science, Technology and Environment.

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Exercised some regulations

• Malaysia and Thailand - expect biosafety
  legislation in 02.
• Philippines - Biosafety Guidelines published in
  1991.
• Indonesia - provisions on biosafety of
  genetically engineered agricultural biotechnology
  products released under the Ministerial Decree
  No. 85/kpts/HK 330/9/1997. The Decree of the
  Minister of Agriculture does not have law
  enforcement power. Furthermore, there is Law No.
  5/1994 for the Ratification of the UN Convention
  on Biological Diversity and Law No. 7/1996 on
  food.
• Singapore - guidelines for Release of GMOs used
  in Agriculture- use of Acts administered by the
  Agri-Food and Veterinary Authority of Singapore
  (AVA)

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Existing legislation in ASEAN

• Generally uses the sanitary and phytosanitary
  requirements, and Acts enacted in these areas, to
  regulate importation of GMOs.
• e.g., Plant Quarantine Act, Animal Control Act
  and Fisheries Act, Food Act and Hazardous
  Substance Act.

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Public Awareness Information

• AFIC Market Research between 1998 -1999 in ASEAN
  (Thailand, Philippines, Malaysia and Indonesia)
  showed that the public in general, was not very
  aware of food biotechnology. Most countries do
  not have structured nor organized public
  education programs on GMOs.
• Many countries have a built-in system of public
  awareness for field trials or commercial release.
• Some have public participation in the decision
  making level.

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Labeling of GM products

• Demanded on the basis of the publics right to
  be informed
• Three choices mandatory, voluntary or no
  labeling (status quo).
• Labeling involves additional cost to producers.

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Access to GMOs by small farmers
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Access to GMOs by small farmers

• Region of small farmers who cultivate areas of
  less than 1 hectare.
• Many of them are resource poor / subsistence -
  products developed to suit their particular
  needs?
• Issue and concern on the use of traditional
  knowledge and biodiversity.
• TRIPs - no specific provisions related to the
  protection of traditional/indigenous knowledge
  (systems, practices, naturally-occurring plants,
  products)

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Policy Recommendations for ASEAN

• Most urgent need -- building local regional
  capacity,
• Human resource is the key to this development
• Transferring of technology and skilled scientists
  can help speed up the process, but technology
  imbedded in the products will do little in
  strengthening the capabilities.
• Major hindrance is Political View and weak
  management infrastructure
• IPR and biosafety systems.

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Human Resource Development

• Capability to pursue high priority biotechnology
  research - Training of scientific and technical
  manpower is a crucial element
• A national effort with strong supportive input
  provided by mutual co-operation within the region
  and international agencies
• ASEAN-help-ASEAN can be coordinated through the
  functional committees and other ASEAN mechanisms.
• Resources must be made available to facilitate
  the flow of people across national boundaries for
  the training and collaborative ST activities
• VUST

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ST Policy, Planning and Organizational Structure

• Biotechnology research requires sophisticated
  infrastructure, including identification of
  appropriate areas, strong management and funding
  system, and appropriately equipped research
  facilities.
• ST infrastructure is complex and in most of the
  region requires a subtle cultural change. Such
  processes take time and perseverance.
• Regional collaboration can be an excellent tool
  to help push members over the hurdle and the
  resistance to change. High-level Heads of State,
  Ministerial, and Senior Official Meetings can
  help to pursue the much needed political support.

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ST Policy, Planning and Organizational Structure

• Fostering supporting management mechanisms,
  excellence and competitive research will evolve
  to generate innovation.
• To attach due importance to the development of
  locally and regional needs.
• Providing incentives for RD (tax regimes,
  venture capital tax incentives, other)
• ASEAN must work within ASEAN to foster the
  linking of the excellent/specialized centers,
  forming networks, combining to build strengths
  and combining strengths to work on regional
  issues of importance.

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ST Policy, Planning and Organizational Structure

• The linking of excellent/specialized centers or
  any other agencies requires commitment in cost
  sharing and making travel and meeting/workshop
  costs available.
• Funding has been difficult, but more difficult
  has been the priority accorded to regional
  commitment.

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Some specific areas on risk issue

• Policy and decision making process.
• Developing legal framework for biosafety
• Training in and implementing risk assessment
• Development on data management and info sharing
• Upgrade technology and preparedness to implement
  a biosafety regulatory framework.
• Developing biosafety clearing house mechanism
  which should facilitate cooperation amongst ASEAN.

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Information Exchange, Regulatory and
Harmonization

• Information exchange ? better understanding, more
  active interactions, stronger region,
• AFTA -- Standards and regulations need to be
  harmonized to reduce any possible friction and
  ensure fair practice.
• Building communication and information access and
  exchange - Critical to the success of a
  harmonization process
• Technology transfer information network

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Information Exchange, Regulatory and
Harmonization

• Misinformation and the lack of scientific
  understanding can lead to poor judgment,
  mismanagement and missed opportunities.
• ASEAN must work together to increase public
  awareness and understanding of ST, and
  particularly, biotechnology. Ensuring public
  awareness at all levels. Prep of documentation
  and information packages

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Intellectual Property Rights

• Role of intellectual property rights in enhancing
  the progression of the regions biotechnology
  capabilities.
• Cultural and traditional practices are being
  tested and put under various constraints due to
  globalization forces. ASEAN needs to work
  together to make the requisite change as
  painlessly as possible.

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Intellectual Property Rights

• On biodiversity, ASEAN countries should come
  together to develop national legislation on
  protection of indigenous and/or traditional
  knowledge and on that basis formulate an ASEAN
  collective position to be advocated at
  international level.
• Countries should develop an inventory and
  registry of their biological resources and
  traditional/indigenous knowledge, taking into
  account the intellectual property implications of
  such inventories and registries.
• There should be a network of information exchange
  and networking among the ASEAN member countries
  for this purpose.

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Intellectual Property Rights

• There should be a network of information exchange
  and networking among the ASEAN member countries
  for this purpose.
• Working with Integrated IP Escrow Service (Patent
  Pool)
• Provide tech owners, the public sector and the
  small business community with a convenient and
  trusted service

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Better communication and greater transparency.