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Evolution of Biosafety Guidelines

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					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.
    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 of
Conduct”.
1996 – ICGEB became an autonomous international
organization.
    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 in
    Agriculture 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.
    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
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
Outcomes of the Rio Summit on biotechnology

• The Rio Declaration on the Environment and
    Development
•   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.
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 the
    benefits 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.
 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.
    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 modified
     organism (LMO) resulting from biotechnology that
     may have adverse effects on the conservation and
     sustainable use of biological diversity.
       Outcome of the CBD on biotechnology

• Cartagena Protocol on Biosafety to the Convention on
    Biological Diversity
•   BSWG 1 Aarhus, Denmark (1996), BSWG 2-5 Montreal,
    Canada (1997-1998), BSWG 6 Cartagena, 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.
        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 Biosafety
  Committee – 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.
       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 in
  Biotechnology” adopted by the Global Consultation of
  Government-designated Experts.
  Cairo, Egypt, December 11-14, 1995
        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.
              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.
        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)
     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”.
 World Summit on Sustainable Development
                (WSSD)
• Dubbed the “Rio + 10” or the “Johannesburg
  Summit” 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
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 …
National Biosafety Committee
         Conceived 1986

      Born January 1993
    Died December 26, 2004
        REST IN PEACE

          (RIP)
THANK YOU

				
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