National Biosafety Policy

1
National Biosafety Policy

• Prof. Athula Perera
• National Coordinator
• National Biosafety Framework Development Project
• Ministry of Environment Natural Resources

2
Why NBF ?

• One of the elements of the framework
• Regulatory system
• Administrative structure
• Risk assessment management
• Public participation
• Biosafety Policy related to Biotechnology

3
The Need

• Biotechnology
• Any technological application that uses
  biological systems, living organisms or
  derivatives thereof, to make or modify products
  or processes for a specific use
• Traditional plant breeding
• Old biotechnology tissue culture, fermentation
• Recently Modern biotechnology
• In vitro nucleic acid techniques including
• Recombinant DNA technology direct injection of
  DNA into cells or organelles, fusion of cells
  beyond taxonomic family -? overcome natural
  physiological, reproductive or recombination
  barriers.. Not used in traditional breeding
  selection

4
Advances Risks

• Advances in
• Medicine
• Agriculture
• Industry
• Risks!!!!
• Biological diversity
• Human health
• Not yet known!
• Uncertainty about potential risks
• Long-term research required.
• Costs of mitigating or reversing damage/harm
  immense far-reaching
• Government of Sri Lanka responsible for health
  status food security of our people

5
Urgent need

• Establish biosafety measures
• GMO/FFP locally produced, imported
• National Policy on Biosafety
• Minimize possible risks
• Extract maximum benefit
• Ensure protection of our traditional
  biotechnology knowledge, practices benefits

6
Principle

• If there is any perceived threat of serious or
  irreversible damage, lack of scientific certainty
  shall not be used as a reason to postpone
  measures to prevent adverse effects on human
  health and the environment.
• Safety First!
• Prove safety prior to use.

7
Our obligations International Conventions

• Sri Lanka ratified
• Convention on Biological Diversity (CBD)
• Cartagena Protocol (CP) on Biosafety
• Conservation of Biological diversity
• Sustainable use of its components
• Sharing of benefits fair equitable
• Protection in safe transfer, handling and use of
  GMO/LMO

8
Policy Framework

• The national policy on biosafety shall conform to
  the National Development Objectives of the
  Government of Sri Lanka

9
Policy Objectives

• Based on precautionary principle
• Supports other related policies complementary
• Implementation of biosafety measures
• Ensure effective regulation management of
  GMO/FFP imported to Sri Lanka based on AIA
• Regulate manage local products
• Promote dissemination of knowledge in safe use
  probable hazards of Mod. Biotech.
• Emphasize biosafety bioethical considerations
• Provide institutional framework for decision
  making, networking, monitoring RD, international
  cooperation in all biosafety matters

10
Policy Principles

• Biosafety regulations based on precautionary
  principle AIA
• Develop our own capabilities in all aspects of
  biosafety
• Manufacture, use, import, export, sale or
  transboundary movement of MB applications,
  practices and products shall conform fully to all
  relevant national legislations
• Public awareness, education and participation in
  decision-making processes essential
• RAM of GMO/FFP according to national biosafety
  regulations
• Industries using MB shall reveal all relevant
  data for consumer protection
• Safety test data fully disclosed and made
  public
• Decisions on biosafety issues shall not be
  overruled in fora that favour other considerations

11
Policy Statements

• Recognizes the importance of protecting its
  people, environment and biodiversity while
  promoting a sustainable social and economic
  development through the safe use of MB
• Recognizes the human health and environmental
  risks that may be incurred by careless
  unscrupulous development of MB and the use of its
  products for agriculture, health, waste
  management other purposes
• Realizes the need for developing our own
  capabilities in biosafety through research
  development and training
• Reaffirms the commitment to the obligations of
  CBD CP

12
Recommendations

• A committee appointed by the Ministry of ENR
  shall be the controlling authority for all issues
  relating to biosafety in Sri Lanka
• Labeling of genetically modified products shall
  be made mandatory free and informed choice for
  consumers
• National safety guidelines and implementation
  practices shall be adopted by industries using MB
• GM detection laboratories as well as resources
  for RAM shall be identified, established and
  supported. They shall be accredited

13
Recommendations.contd.

• Assess, identify and develop priorities in human
  resource development
• Enhance public awareness of MB and potential
  risks/benefits RAM techniques
• Support research into risks to environment
  human health (different envts./organisms., food
  habits.)
• Review and update safety standards to incorporate
  changes in MB

14
More

• Establish develop knowledge bases
  infrastructure for information exchange
• Establish a Master Plan for Biosafety implement
  policy matters
• Interim period enact existing legislations to
  regulate manage GMP/FFP

15
How did we do this?

• National sub-committee appointed by NCC
• Director/NASTEC Director Biotech. Centres/
  Chairpersons of CARP NSF DG/Agric. Ministry
  of Health Dept. of Fisheries, Animal prod.
  Health, Min. of Finance, Director/Biodiversity,
  Director, Planning, M of ENR, Chairpersons of
  other national sub-committees
• Regulations
• Administrative structure
• Technology techniques
• Report to NCC
• 03 National Consultative Meetings with ALL
  stakeholders
• Newspaper notices, website
• Absolute transparency

16
National database on BB
National Survey

• Policies, Strategies, Action Plans, Research and
  Development
• Collecting Legal Documents
• Experts/ Resource persons
• Physical Resources and Education Training
  Facilities
• Existing Techniques, Technologies and Knowledge
• Existing Biotechnology Industries

17

• Existing import/ export items related to
  biotechnology/biosafety
• Existing service sector related to biotechnology
  and biosafety
• Media
• Existing framework for importation of materials
  relevant to Biosafety
• Health sector ministry/ hospitals/nursing
  homes/ ayurvedic hospitals dispensaries
• Libraries

18
Major Fields of Expertise
19
Technological Capacity
20
Research Activities
21
Educational Qualifications
22
Distribution of Basic Degree
23
Name of The Institute Available Techniques Available Equipments
Agricultural Biotechnology Centre. Extraction of DNA, cloning vector, DNA Sequencing, PCR Assays, None isotopic labelling of DNA/RNA, gene gun, Tissue culture, ELISA Assays, Fermenter/Bioreactor, Electrophorosis, Bio- processing, Bio-leaching, Bio pulping, Bio-bleaching. UV Visible Spectrophotometer, ELISA Reader, Thermo cycle (PCR machine), Polaroid Camera, Autoclave, UV transilluminor, Freeze dryer, Freezer, Laminar Flow, Ice Machine, Vertical Electrophoresis Apparatus, Thermal Cycler, Gene gun, Bio reader, Confocal Imaging System, UPS.
Rajarata University of Sri Lanka Laminar Flow hood
Department of Molecular Biology And Biotechnology Extraction of DNA, Cloning vector, DNA Sequencing, ELISA Assays, Electrophoresis. BOC Freezers, Centrifuges, Spectrophotometers, DNA Sequencing Apparatus, Gel electrophoresis units (Horizontal/Vertical), PCR Machine, ELISA Plate Reader/ Washer, Incubator/Oven, Autoclave, Ice Machine, Shaker water bath, Co2 incubator, Shaker incubator.
Grain Legume and Oil Crop Research and Development Centre Tissuculture (Shoot tip culture, Callus culture etc. Laminar Flow, Autoclave.
Department of Microbiology PCR, Cloning, Microbial biotechnology, Thermal cycler, Ultra Freezer, ELISA Reader, Spectrophotometer, Transilluminator, Micro centrifuge, BOD Apparatus, Fermenter, Laminar flow.
24
Plant Virus Indexing Centre. Molecular based virus diagnostic Techniques, Serological virus detection techniques. Ultra Centrifuge, Benchtop Centrifuges, Thermo Cycler, Electrophoresis app, UV Spectrometer, UV Transilluminator, Polaroid Camera, Liquid N dewars,
Industrial Technology Institute
Sugarcane Research Institute Tissue culture, Fermentation techniques. Microscopes, ELISA Reader, High Speed Centrifuge, Thermo Cycler, Fermentor.
National Science Foundation
Regional Agricultural Research and Development Centre.
Hector Kobbekaduwa Agrarian Research and Training Institute.
Central Environmental Authority. Auto Clave, Dry oven, Incubators (Single Door and Double Door)
Institute of Post Harvest Technology. Oven, Incubator, Auto clave, HPLC, Spectrophotometer, Colorimeter, Viscometer, Refrigerator, Rotary Evaporator, Kjeldahl, Ebiliometer, Moisture Balance, Whiteness Meter.