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Evolution of Biosafety Guidelines in Thailand *

Evolution of Biosafety Guidelines in Thailand *. Banpot Napompeth Regional Project on Capacity Building in Biosafety of GM Crops in Asia FAO Regional Office for Asia and the Pacific Bangkok, Thailand * Presented at the workshop on “Application of Biosafety

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Evolution of Biosafety Guidelines in Thailand *

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  1. Evolution of Biosafety Guidelines in Thailand* Banpot Napompeth Regional Project on Capacity Building in Biosafety of GM Crops in Asia FAO Regional Office for Asia and the Pacific Bangkok, Thailand * Presented at the workshop on “Application of Biosafety Guidelines” organized by BIOTEC, Century Park Hotel, Bangkok, August 23, 2005.

  2. International Center for Genetic Engineering and Biotechnology (ICGEB) 1987 - ICGEB established as a UNIDO project in Trieste, Italy and New Delhi, India. UNIDO/ICGEB realized a need for safety on the safe use of genetically engineered microorganisms(GEMs) in the environment leading to the formation of working group in 1990 to develop a “Code ofConduct”. 1996 – ICGEB became an autonomous international organization.

  3. National Center for Genetic Engineering and Biotechnology (NCGEB) • 1983 - NCGEB established under Ministry of Science, Technology & Energy (MOSTE). • 1986 - Status Report on the Prospect of Biotechnology inAgriculture indicating need for biosafety regulatory system. • 1990 - Status Report on a Feasibility Study on Biosafety submitted to NCGEB considered and Biosafety Subcommittee established in November 1990 with an aim to draft a national biosafety guideline. • December 1991 – NSTDA established under Ministry of Science, Technology& Environment and the acronym NCGEB changed to BIOTEC.

  4. UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment • UNIDO/UNEP/WHO/FAO Ad Hoc Working Group formed in 1990 to work out a practical guideline through a series of consultations with international experts and scientists from developing countries. • UNIDO Expert Group Meeting for the Formulation of a Voluntary Code of Conduct for the Release of Genetically Engineered Microorganisms (GEMs) in the Environment. - UNIDO, Vienna, Austria, March 6-8, 1991 - ICGEB, Trieste, Italy, July 8-10, 1991

  5. United Nations Conference on Environment and Development (UNCED) • UNCED Ad Hoc Workshop of Senior Experts on International Guidelines on the Environmentally Sound Application of Biotechnology New Delhi, India, October 23-25, 1991 • The Earth Summit (the Rio Summit) in Rio de Janeiro, Brazil, June 1992

  6. Outcomes of the Rio Summit on biotechnology • The Rio Declaration on the Environment andDevelopment • Agenda 21 – Program of action for sustainable development Chapter 16 – Environmentally sound management of biotechnology Program Area D: Enhancing safety and developing international mechanism for cooperation.

  7. Outcomes of the Rio Summit on biotechnology • Convention on Biological Diversity (CBD) • Finalized in Nairobi in May 1992 • Entered into force on 29 December 1993. • The objectives of the CBD are the conservation of biological diversity, the sustainable use of its components and fair and equitable sharing of thebenefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.

  8. Outcomes of the Rio Summit on biotechnology • CBD Article 8 In-situ conservation. Each Contracting Party shall, as far as possible, and as appropriate: (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms (LMOs) resulting from biotechnology which are likely to have adverse environmental impacts hat could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

  9. Outcomes of the Rio Summit on biotechnology • CBD Article 19 - Handling of biotechnology and distribution of its benefits. • Para 3. The parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement (AIA), in the field of safe transfer, handling and use of any living modifiedorganism (LMO) resulting from biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity.

  10. Outcome of the CBD on biotechnology • Cartagena Protocol on Biosafety to the Convention on Biological Diversity • BSWG1 Aarhus, Denmark (1996), BSWG 2-5 Montreal, Canada (1997-1998), BSWG 6Cartagena, Colombia (1999). • Adopted at ExCOP in Montreal on January 29, 2000 • Entered into force on September 11, 2003. • The objectives of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer,handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

  11. Thailand Biosafety Guidelines • June 1992 – First drafts of biosafety guidelines completed and submitted to NSTDA Board for approval with a recommendation to establish the “National BiosafetyCommittee – NBC”. The guidelines approved were: - Biosafety Guidelines in Genetic Engineering and Biotechnology: For Laboratory Work - Biosafety Guidelines in Genetic Engineering and Biotechnology: For Field Work and Planned Release • January 1993 – National Biosafety Committee established with BIOTEC as secretariat and BIOTEC director as secretary and Institutional Biosafety Committee (IBC) initiated. • August 2005 – 27 IBCs established.

  12. UNEP International Guidelines • 1991 - UNCED Ad Hoc Workshop of Senior Experts on International Guidelines on the Environmentally Sound Application of Biotechnology New Delhi, India, October 23-25, 1991. • CBD Second Conference of the Parties (COP2) Decision II/5 to establish an Open-ended Ad Hoc Working Group on Biosafety (BSWG) to develop a draft protocol on biosafety. Jakarta, Indonesia, November 1995. • “UNEP International Technical Guidelines for Safety inBiotechnology” adopted by the Global Consultation of Government-designated Experts. Cairo, Egypt, December 11-14, 1995

  13. UNEP International Guidelines • UNEP Intl. Technical Guidelines for Safety in Biotechnology was adopted in December 1995 after COP2 in November in cognizance of CBD Decision II/5 to develop a protocol on biosafety and as an interim mechanism during the development and implementation of a protocol. • UNEP Intl. Guidelines inaugurated at CBD COP3(November 4-15, 1996) in Buenos Aires, Argentina.

  14. General Principle • Safety of any application is achieved by carrying out certain sequential steps, as follows: 1. Identifying any hazard 2. Categorizing the risks (BL 1,2,3,& 4) 3. Assessing the risk (Risk Assessment) 4. Managing the risk (Risk Management) • Management strategies should be commensurate with the results of risk assessment, and Risk Communication.

  15. Applications Approved by NBC • Development of a chicken vaccine protective against avian colisepticemia in Thailand (Tel Aviv University/Chulalongkorn University) 1991 (rejected) • Seed production of FLAVR SAVR tomato (Calgene, USA) 1993 • [40 plant spp. known to be GMed prohibited to be imported except for research, DOA, 1994] • Bt cotton (Oct 95, Jul 96, Apr 97) Monsanto • R&R cotton (Feb 98) Monsanto • Bt corn (Oct 96) Novartis • R&R corn (Feb 98) Monsanto; (Aug 98) Cargill • Trasnsgenic fluorescent zebra fish (Sept 8, 03) BIOTEC (rejected)

  16. Cabinet “Biobomb” April 3, 2001 Because of the pressure from the Association of the Poor and NGOs against GMOs, the Cabinet passed a “decision” to declare a moratorium and ban all field trials of GM crops pending the enactment of the “Biosafety Law”.

  17. World Summit on Sustainable Development (WSSD) • Dubbed the“Rio + 10” or the“JohannesburgSummit” or the “Jo’burg Summit” August 26 - September 2, 2002, Johannesburg, South Africa • Johannesburg Plan of Implementation – JPOI - To reduce biodiversity loss by 2010 - Partnership Types I and II

  18. NBC ceased to operate since December 27, 2004 Where do we go from here? What do we do for our dreams to survive? How do we keep our NBC alive, As we used to do? Deep in my heart I’m concealing, Things that I’m longing to say, Scared to confess what I’m feeling, Frightened you’ll slip away, You must love me … You must love me …

  19. National BiosafetyCommittee Conceived 1986 Born January 1993 Died December 26, 2004 REST IN PEACE (RIP)

  20. THANK YOU

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