National Biosafety Policy

Prof. Athula Perera

National CoordinatorNational Biosafety Framework

Development ProjectMinistry of Environment &

Natural Resources

Why NBF ? One of the elements of the

framework:

Regulatory system Administrative structure Risk assessment & management Public participation Biosafety Policy related to

Biotechnology

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

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

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

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.

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

Policy Framework

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

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 R&D, international cooperation in all biosafety matters

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

RA&M 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

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

Recommendations A committee appointed by the Ministry

of E&NR 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 RA&M shall be identified, established and supported. They shall be accredited

Recommendations….contd.

Assess, identify and develop priorities in human resource development

Enhance public awareness of MB and potential risks/benefits & RA&M techniques

Support research into risks to environment & human health (different envts./organisms., food habits….)

Review and update safety standards to incorporate changes in MB

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

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 E&NR, 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

National database on B&B

National Survey

1. Policies, Strategies, Action Plans, Research and Development

2. Collecting Legal Documents

3. Experts/ Resource persons

4. Physical Resources and Education & Training Facilities

5. Existing Techniques, Technologies and Knowledge

6. Existing Biotechnology Industries

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

Major Fields of Expertise

44

79

9

43

6 20

10

20

30

40

50

60

70

80

90

Animal

Plants

Human

Microbes

Food

Phamaceuticals

Major area

No o

f exp

erts

Technological Capacity

3128

32

25

34

46

0

5

10

15

20

25

30

35

40

45

50

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As

sa

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Techniques

No

of

Ex

pe

rts

Research Activities

12

29

33

22

25

23

13

Production of microbes DNA markers in plant/animal breeding

DNA fingerprinting Development of DNA probes

DNA/RNA based desease diagnostics Industrial biotechnology

Fermentation technology

143

71

29

24

Basic Degree M.Sc. M.Phill Ph.D.

Educational Qualifications

66

52

114 5 5

B.Sc.(Agriculture)

B.Sc.

B.Sc.Engeeniaring

B.Veterinary Science

MBBS

B.Dental Science

Distribution of Basic Degree

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.

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.