National Biosafety Policy Prof. Athula Perera National

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
(No Transcript)
24
(No Transcript)