Sri Lanka  

 

RISK ASSESSMENT AND MANAGEMENT

Prof. A. L. T. Perera
Head, Dept. of Agriculture Biology, Faculty of Agriculture, University of Peradeniya
Ms. S. I. Rajapakse
Research Assistant, Biodiversity Secretariat, Ministry of Environment and Natural Resourcess

SRI LANKA STATUS REPORT ON BIOSAFETY -RISK ASSESSMENT AND MANAGEMENT

Contents
Introduction
Present Status

Implementation of Article 19 of the CBD
Application of Biotechnology
Present Status of Biotechnological Research
Actions and measures adopted
Some institutions involved in biotechnology
Some of the Experts
Biosafety Regulations/Guidelines
National Technical Committee on Biosafety Guidelines
Legal Measures
Capacity building
Recommendations


INTRODUCTION

Sri Lanka has a high number of flora and fauna per unit area, distributed among a wide range of different terrestrial and aquatic ecosystems and habitats. Many of these species are endemic to the country. These biological resources are being rapidly lost due to high population density, poverty and unemployment, leading to habitat destruction, over - exploitation, etc. Rich ecosystems are converted to various other uses, which yield higher financial returns, in addition to inadequacy in institutional capacities, introduction of exotic species, etc.

Sri Lanka has been named as one of the 25 biodiversity hotspots of the world, especially the South Western region of Sri Lanka. Therefore, conservation of biological diversity in Sri Lanka is of national interest and of global relevance. The Convention on Biological Diversity was signed and ratified by Sri Lanka in July 1992 and March 1994 respectively. The Ministry responsible for the subject of Environment has the duty to ensure that the provisions of the Convention are adhered to.

Due to inadequate infra-structural development including human resources and poor investment in the field of biotechnology, and lack of legal instruments and institutional framework to control and regulate import of LMOs/GMOs and their products, Sri Lanka's native biodiversity is at risk and will have adverse impacts in trade of LMOs/GMOs in an open economy. There have also been reports that products containing LMOs had been imported for release into the local market for household clearing purposes, waste management, agriculture purposes, etc.

Sri Lanka signed the Biosafety Protocol on 24 May 2000 and is planning to ratify it as early as possible. Before the ratification Sri Lanka should establish domestic legal measures and build capacity in the area of biosafety.

The Ministry of Environment is the National Focal Point and is obliged to implement the articles of the protocol.

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PRESENT STATUS

Implementation of Article 19 of the CBD

(i) "Take measures to provide for the effective participation in biotechnological research activities by those contracting parties which provide the genetic resources for such research" - no measures have been taken with regard to this provision so far.

(ii) "Take all practicable measures to promote and advance priority access on a fair and equitable basis by contracting parties to the results and benefits arising from biotechnologies based upon genetic resources provided by those contracting parties" - some measures are in place.


Application of Biotechnology

The following areas of priority have been identified for development in Sri Lanka within the framework of safety for human health and the environment.

1. Agricultural biotechnology
2. Medical biotechnology
3. Industrial biotechnology
4. Biosafety
5. Bioinformatics
6. Human resource development & capacity building
7. Management


Present Status of Biotechnological Research

Until the early 1990's, biotechnology in Sri Lanka was mainly concerned with plant tissue culture with the exception of the molecular biology work done by a few medical research groups. Hence, the development of facilities and resource allocations were directed towards micropropagation, without much concern for the future potentials of new biotechnologies. However, an upsurge of interest on the new biotechnologies has taken place in the new millennium, and at present, many universities, research institutes and government departments carry out research in biotechnology. The number of personnel skilled in biotechnological operations are still low. Table 1 shows the involvement of the scientists in biotechnological research and development in the country as at present (2000).

The National Science Foundation (NSF), The Council for Agricultural Research Policy (CARP) and the National Research Council (NRC) provide funds for research in biotechnology and thereby maintains a limited sort of management.

Table 1.  Research and Development in Biotechnology

___________________________________________________________

               R & D                                             Current status                Future

                                                                                % personnel involved

Genetic engineering and DNA markers               18                        28

in crop breeding          

DNA/Immuno diagnostics                                    63                        68

Vaccines                                                              03                        06

Gene therapy                                                        00                        03

Environmental biotechnology                                 05                        12

Industrial biotechnology                                         04                        07

Food biotechnology                                               04                        08

 

Activities                                                          Investigators (%)

 

DNA/RNA/Protein extraction                              80

Culture of microorganisms/tissue                           69

Use of EMOs/GMOs                                           34

Using pathogens/vectors/animals                            53

Using cloning vectors/host systems                         41

Production of recombinant molecules                     39

Radiolabelling of biomolecules                                39

PCR assaya/DNA sequencing                                79

Production of monoclonal antibodies                       09

ELISA assays                                                         38

Production of transgenic animals/plants                    11

Use of fermentor                                                     11       

_____________________________________________________________

(National Science Foundation, 2001)

The data shows that there are only two main areas of research at present viz. disease diagnosis (63%) and crop improvement (18%) which can be further strengthened and developed as they are at present in the early stages.

There are other very important areas in biotechnology such as food biotechnology, industrial biotechnology and environmental biotechnology that need to be identified, programmes prioritised and assisted. They will be benefited immensely by the application of the new technologies.
A significant feature arising from this information is the lack of partnership and interest by the industrial sector.

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Actions and measures adopted

After 1998, the formation of various biotechnology fora and committees by research governing bodies such as The Specialists Group of Agricultural Biotechnologist of CARP (Council for Agricultural Research Policy), The Biotechnology Working Group (committee) of the NSF (National Science Foundation) and The Biotechnology Panel of NRC (National Research Council) can be considered as a step forward for planning and managing the use of biotechnology for the benefit of the country. The CARP committee has identified national priorities for agricultural biotechnology, whilst the NSF and NRC have listed important areas for research and development in biotechnology.

The universities have developed their curricula to include biotechnology at undergraduate and postgraduate levels. New departments to deal with biotechnology have been created.

The Asian Development Bank (ADB) has provided loan facilities to develop biotechnology at both undergraduate and postgraduate levels in several universities, as well as in some institutes. Through this loan facility, the University of Peradeniya has established two buildings with equipment for developing biotechnology capabilities at undergraduate level (Biotechnology Laboratory, Faculty of Science) and postgraduate level (Agricultural Biotechnology Centre, Faculty of Agriculture). Moreover, scholarships for local training of up to 50 M.Sc. students and 10 Ph.D. students, as well as for upgrading the faculty staff, and for consultancies and workshops were also available through this programme. Funds were also available for upgrading and developing biotechnology at the University of Colombo.

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Some institutions involved in biotechnology

· Research Institutes: Institute of Fundamental Studies, Industrial Technology Institute, Coconut Research Institute, Rubber Research Institute, Rice Research Institute, Veterinary Research Institute, Sugar Research Institute, Tea Research Institute, Plant Genetic Resources Center, etc.
· Universities: University of Colombo, Eastern, Kelaniya, Peradeniya, Rajarata,
Ruhuna, Sabaragamuwa, Sri Jayawardenapura, etc.
· Private sector: Distilleries

Institutions involved in the use, implementation and monitoring of biosafety include Ministries relevant to Science and Technology, Health, Fisheries and aquatic resources, etc. National Science Foundation, Department of Agriculture, Animal Production and Health, Customs, Wild life Conservation, Forest, National Aquatic Resources Agency, Central Environment Authority, etc.

Some of the Experts
· Prof. Athula Perera, Head, Department of Agricultural Biology, Faculty of Agriculture, University of Peradeniya, Peradeniya
· Prof. I A U N Gunatilleke, Head, Department of Botany, Faculty of Science, University of Peradeniya, Peradeniya
· Prof. Eric Karunanayake, Dept. of Molecular Biology, University of Colombo, Colombo 03.
· Prof Upali Samarajeewa, Head, Dept. of Food Science, Faculty of Agriculture, University of Peradeniya, Peradeniya
· Dr. A H M Jayasooriya, Sr. Dy. Director, Plant Genetic Resources Center, Gannoruwa
· Prof. G S Widanapathirana, Professor of Microbiology, Dept. of Molecular Biology, University of Kelaniya, Dalugama, Kelaniya

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Biosafety Regulations/Guidelines

Sri Lanka is at present establishing regulations for biosafety that includes guidelines for laboratory-based experiments, for testing in the green house and for small and large scale field trials of genetically modified plants and organisms and for their commercialisation and release into the environment or food chain, taking into consideration the Cartagena Protocol on Biosafety which advocates a global system for assessing the impact of GMOs on biodiversity as well as the "precautionary approach" described in the 1992 Rio Declaration on Environment and Development. Sri Lanka is at present considering the introduction of guidelines or mandatory measures for labelling GMFs.

The National Science Foundation has drafted the guidelines for the safe use of recombinant DNA technology in the laboratory. The guidelines are applicable to all laboratory research and other laboratory activities involving rDNA (recombinant DNA) molecules in Sri Lanka. The guidelines are for the safe use of rDNA technology in the laboratory. The safety considerations are presented under three main areas of research viz. (i) genetic manipulation of microorganisms, including animal and plant viruses and viral vectors (ii) genetic manipulation of plants and plant pathogens and (iii) genetic manipulation of animals. The procedure to be followed by the investigator/s undertaking rDNA work is briefly outlines in the beginning of the document for his/her convenience.
As prescribed in the guidelines, the investigator/s undertaking the rDNA work and the institution/s where the work is to be performed must establish procedures for the safe conduct of all rDNA research activities.

The institutional mechanism of framework for implementation of guidelines is also described. The guidelines prescribe specific action required to establish safe procedures for rDNA research. The investigator/s and the institution/s would be responsible for the compliance of these guidelines and the safe conduct of rDNA work, to ensure protection of health and the environment. An Institutional Biosafety Committee (IBSC) would serve as the advisory body to all rDNA work conducted within an institute. All institutions conducting rDNA work should establish IBSCs. At national level, a rDNA Advisory Committee (RAC) will serve as the focal point on rDNA activities in the country and provide advice and guidance to all institutions and their IBSCs and investigators. The investigator's/s' role and responsibilities, the structure and composition of advisory and implementation bodies, their scope, responsibilities and functions are proposed in the guidelines.

The overall, comprehensive, national biosafety guidelines, including guidelines for field research and release, are being finalized by the Ministry of Environment.

At present collaborative research is carried out by individuals and various academic institutions. The current trend in the use of genetic resources for the production of LMOs/ GMOs indicates a timely need for a comprehensively drawn set of National Biosafety Guidelines in accordance with the Biosafety protocol. The National Experts Committee on Biological Diversity of the Ministry of Environment and Natural Resources propose to develop National Biosafety Guidelines. In this regard, a sub committee, The National Technical Committee on Biosafety Guidelines was established in 1999.

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National Technical Committee on Biosafety Guidelines

The committee has developed a draft of the National Biosafety Guidelines. The Fifth draft of the National Guidelines for import and planned release of genetically modified organisms and products thereof have been reviewed.

This includes the following.
· Objective, scope and general principles
· Implementation procedure - submission of a proposal, evaluation and public participation, accidental release and emergency measures, responsibility for compliance
· Institutional arrangements - mechanism of implementation, safety at institutional level, placing on the market, final provisions
· Summary of procedures
· Annexes - information on GMO and its release, additional information on transgenic plants, organisms for biological control, organisms for bioremediation, risk analysis, IBC assessment of a planned release proposal, information sheet for purposes of public notification, and IBC report on planned release after its completion.

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Legal Measures

Before the ratification of the Protocol, Sri Lanka should establish domestic legal measures and build capacity in the area of biosafety. A committee on Domestic Legal Measures on Biosafety has been established to discuss and clarify important matters relating to the existing legal framework, to handle legal matters, to identify legal gaps, etc. related to biosafety and biotechnology.

Committee on Domestic Legal Measures on Biosafety

The committee includes the following members.

· Secretary to the Ministry of Environment
· Government Institutions involved with biosafety matters: Agriculture, Health, Trade, Forests, Wild life, Livestock, Fisheries and Aquatic Resources, Customs, Food and Drug, etc.
· Experts on Biosafety related areas
· Legal Officers
· Representatives from NGOs
· Representatives from private sector

The committee has met several times and reviewed the relevant national legislation on importation of genetically modified organisms and relevant measures have been carried out.

Some of existing legal instruments:
Fauna and Flora Protection Ordnance
Plant Protection Act
Fisheries and Aquatic Resources Act
Forest Ordinance
National Heritage Wilderness Areas Act
Food Act
National Environmental Act
Diseases of Animals Act
Code of Intellectual Property Act, etc.

Code of Ethics

A technical committee has been set up by the Ministry of Environment and Natural Resources to formulate a Code of Ethics for research.
A draft Code of Ethics for research on Biological Diversity involving Access to Genetic Resources has been prepared.

Ban of GMFs

Ban of GMFs comprising 21 food items by the Food (Genetically Modified Foods) Regulations-2000 under the Food Act was deferred, but will be re-imposed as the World Trade Organization (WTO) is not against it.

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Capacity building

National Biosafety Frame Work

Sri Lanka is identified as a potentially eligible country to participate in the UNEP-GEF Biosafety Project in the Asia-Pacific region. Sri Lanka is in the process of preparation of the National Project Document (Budget and the work plan) and hopes to begin implementing the project in the latter part of 2002.

Risk assessment and management

No mechanism is in place to evaluate the potential risks and management of the range of Genetically Modified Organisms and/or their products.

Biosafety Clearing House

Establishment of Biosafety Clearing House at Biodiversity Secretariat in Ministry of Environment and Natural Resources, strengthening existing biodiversity and biosafety information exchange mechanisms and facilitating information exchange through electronic and print media and implementation of biosafety clearing house through the UNEP/GEF Biosafety Project should be carried out.

Sri Lanka is in the process of developing databases on all biosafety aspects.

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RECOMMENDATIONS

· Facilitate the setting up of risk assessment capacities.

· Recommendations proposed at the Regional Workshop on Biotechnology and Biosafety, 1997.

- Regional cooperation for building capacities for protection of biodiversity and implementation of Biosafety protocol.

Regional cooperation in the following:
- information sharing
- training-exchange of scientists
- collaborative research
- development of common measures(legislative, administrative, policy) for the access of genetic material
- common strategy for transfer of LMOs / GMOs
- designation of focal institutions related to biotechnology
- SAARC cooperative fund for research and development, etc.

Regional cooperation in capacity building identified the following:
- identification of centers of excellence in Biotechnology
- preparation of a regional directory of experts on biotechnology and biosafety
- communication and interaction with other sectors like science, technology, agriculture, etc. established as SAARC technical committees, etc.
- national biodiversity action plans should include species distribution and population dynamics for future biosafety assessment in relation to modern biotechnology
- liability and compensation be on "polluter-pay" basis.

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