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