updates on biosafety regulations in sri lanka -...
TRANSCRIPT
Updates on biosafety regulations in Sri Lanka
R.H.M.P.Abeykoon (BSc. Agric. Hon.) ,(MSc. Forestry),
Director, Biodiversity,
Ministry of Mahaweli Development and Environment Sri
Lanka.
Introduction
65610 km2
Among the CBD thematic areas
Agricultural Biodiversity,
Forest Biodiversity,
Island water Biodiversity,
Island Biodiversity,
Marine and coastal Biodiversity
Mountain Biodiversity
Sri Lanka is one of the smallest, but biologically diverse countries in Asia.
Consequently it is recognized as a Biodiversity hotspot of global and national importance together with Western Ghats of India
(34 ).
Much of the species are endemic, a reflection of the island's separation from the Indian subcontinent since the late Mesozoic. This is especially relevant for mammals, amphibians, reptiles and flowering plants.
species richness of selected faunal and floral group of Sri Lanka
(the national red list 2012 Sri Lanka)
Taxonomic Group Number of Species Number of Endemic Species
Angiosperms 3,154 894
Gymnosperms 2 0
Pteridophytes 336 49
Spiders 501 257
Marine crustaceans 7420
Fresh water crabs 51 50
Dragonflies 118 47
Ants 194 33
Bees 130 0
Butterflies 245 26
Leafhoppers 2570
Dung beetles 10321
Bivalves 2870
Gastropods 4690
Land snails 253 205
Marine fish 13770
Fresh water fish 91 50
Amphibians 111 95
Reptiles 209 125
Resident birds 237 27 + 6 Proposed
Mammals 124 21
Sri Lanka is a valuable repository of crop germplasm
especially rice.
There is also significant crop genetic diversity among species
pepper,
cardamom,
chilli,
grain legume,
root crops,
fruit crops
vegetables.
Biotechnology
• Biotechnology is the one of main technology used in agricultural sector
• Definition
“use of living systems and organisms to develop or make usefulproducts, or "any technological application that uses biologicalsystems, living organisms or derivatives thereof, to make or modifyproducts or processes for specific use" (UN Convention on BiologicalDiversity, Art. 2)
For thousands of years, humankind has used biotechnology in
agriculture, food production, and medicine.
Not only that this technology has been used to make bread, cheese, beer and curd
• Biotechnology is not a new process in Sri Lanka as well. Traditional animal and plant breeding techniques such as
- hybridization
- selection
of plant and animals have been used to produce verities with specific characteristics for higher yield, drought, salinity tolarent and disease resistant etc.
Major challenge faced by the agricultural
researchers is
• To meet the food need for growing population while reducing poverty and protecting the environment the with using limited research funds.
Therefore in the late 20th and early 21st century, biotechnology has expanded to include new and diverse sciences such as
Genomics,
Recombinant gene technologies,
Applied immunology,
Development of pharmaceutical therapies
Diagnostic tests.
.
• Modern biotechnology allows to researchers to take a single gene from a plant or animal cell and insert it in to another plant or animal cell to give it a desired characteristics such as resistant to a specific pest or disease.
Expected Benefits from Genetically Modified Organisms
Pest Resistance - Eg. Brinjol from fruit and shoot borer.Possible Economic Benefit - Eg. minimize the chemical
inputs with maximum harvest
Cold/Drought/Salinity Tolerance - Eg.
Nutrition – Eg. golden rice had enough beta-carotene
The possible risks
Ineffective Safety Testing for Genetically Modified Products
Effects on the Environment and non-Target Organisms and the human
Loss of biodiversity,
resistance to pesticides,
the development of “super weeds”
Emergence of secondary pests
Allergy for human
National Biosafety Systems
Basis of the National Biosafety Systems
• International Treaties : CBD, Cartagena Protocol
• Current Government Policy priorities
• Biodiversity Conservation in Sri Lanka A Framework for Action- 1993
• Biodiversity Conservation in Sri Lanka A Framework for Action – Addendum - 2007
The Convention on Biological Diversity (CBD)Sri Lanka:
• Status of Signing- Signed June, 1992
• Ratified - March, 1994
The Cartegena protocol on Biosafety
• Singed : 2000Ratify : 2004
• Article 8 of the CBD (in-situ conservation)
• (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health;
National Biosafety regulations of Sri Lanka
The Mahaweli Development and Ministry is the national focal point for the CBD and the Cartagena Protocol on Biosafety.
National Biosafety Framework prepared in April 2005.
The overall objective of the
“is to ensure that the risks likely to be caused by modern biotechnologyand its products will be minimized and biodiversity, human health andenvironment will be protected in a maximum way, regulating thetransboundary movements through formulation of relevant policies,regulations, technical guidelines and establishment of managementbodies and supervisory mechanisms”
The biosafety Framework is based on precautionary approach with following two objectives.
To provide an overview of current situation in the country that was assessed during the National Biosafety Framework development project and identify what is currently in place in Sri Lanka (i.e. policies, legislation, administrative system etc.).
To identify what still needs to be done to complete the National BiosafetyFramework (the missing legislation, which still needs to be drafted/ adopted, gaps in the administrative or enforcement systems etc.)
Under the NBF the national coordinating committee (NCC) established consisting of representatives of biosafety related sectors and institutions such as,
Ministry of Environment (Chairman of NCC) ,
Ministry of Justice ,
Ministry of Health,
Ministry of Agriculture,
Ministry of Animal Production and Health,
Department of Wild life Conservation,
Forest Department
Department of Agriculture
Department of Fisheries etc.
National biosafety Framework described
the requirement of,
National policy on biosafety, new law and enforcement system, system to handle notifications or request for authorizations, monitoring and enforcement mechanism for promoting and facilitating public awareness and
participation.
Guidelines for, Import of GM, internal transport of GM production of genetically modified organism (GMO)
Scope is the Biosafety regulations and guide lines are applicable to
All research and development activities of modern biotechnology conducted in
laboratories of the government research institutes,
state enterprises,
universities,
international organizations,
private companies or non-governmental organizations.
It applies to laboratory and field trial, trans-boundary movement, transit, handling and use of all GMOs/LMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
Country specific guidelines for import of GMOs and products
Guide lines for internal transport and release of GMOs and products
Guide lines for the production of Genetically Modified Organisms.
The guidelines for the safe use of rDNA technology in the laboratory (NSF)
.
Regulatory mechanism according to the National policy on biosafety Sri Lanka:
Applicant
NATIONAL FOCAL POINT
Proposal from applicant
Competent Authorities in
relevant fields of application (e.g. line
Ministries)Approved with modifications
Cost-benefit-risk analysis
Feasibility or Applicability of project to country
Public
consultation
Environmental Impact Assessment (EIA)
Legislation
Approved for initiation
Application rejected
Proposal forwarded
Existing laws and regulations
Some information regarding the Existing national laws and regulations which can be used to regulate the GMOs/LMOs in some extent given below.
Fauna and Flora protection Ordinance No.2 of 1937
Section 37 and 38(b) of this Ordinance has allowed importing of any GM –animal only for research purposes.
Animal Disease Act, No.59 of 1992c)
Animal Feed Act, no 15 of 1986
Plant Protection Act, No 35 of 1999
This Act is provisions to prevent the introduction of any organism harmful or injurious plants or destructive to plant in Sri Lanka. These provisions can be used not only prevent the entry of plants and animal, but to prevent the import of any genetically modified plasmids that could be potentially harmful to plants (Section 15).
Consumer Affairs Authority Act No,9 of 2003
This Act can issue general directions to manufacturers or traders to label the goods in respect of price marking, packaging, sale or manufacture of the goods(Section 10(1) (a)). Since all genetic modifications relate to the manufacture of a good, this section can be used to label all goods with GM.
Food Act, No.26 1980 amended by act no. 20 of 1991.
Fisheries and Aquatic resources Act, No. 2 of 1996
Intellectual property Act, No 36 of 2003
Water Hyacinth Ordinance, No. 09 of 1909
This ordinance provide a effective means to prevent the entry in to or keep in one’s any GM plants or parts that can be named in a gazette regulation.
Biosafety Act Final draft prepared
overall regulation of GMO/LMO did not cover in the above Acts and Ordinances. Therefore, National Biosafety framework Sri Lanka and the National biosafety policy proposed to draft and enact the new regulation with the following detail to regulate and monitor the applications of modern bio-technologies including all GMOs /LMOs and products.
i)The approving authority(Its composition, powers and duties)
ii)The procedure for granting approval
iii) Monitoring mechanism and powers vested in it
iv)Enforcement powers
vi) Offences and related aspects
vii) Powers to make regulations to enforce the provisions of the Act
Thanks you
for your attention