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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102951
Status
Published
Date of creation
2012-01-03 16:57 UTC (andrew.bowers@cbd.int)
Date of publication
2012-01-03 16:57 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Sri Lanka
Contact officer for report
Coordinates
Mr. K. A. I. D. Silva
Director (Biodiversity)
Ministry of Environment
82, "Sampathpaya", Rajamalwatta Road
Battaramulla
Sri Lanka
Phone:+0094 011 2887068
Fax:+0094 011 2887061,+0094 011 2887068
Email:koralage2001@yahoo.com
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Following were consulted in preparation of this report. Mr. Gamini Gamage, Former Director (Biodiversity)/Additional Secretary (Environment & Policy Planning), Ministry of Environment. Ms. S. Iresha Rajapakse, Environment Management Officer, Biodiversity Secretariat, Ministry of Environment, Members of National Coordinating Committee on Biosafety
Submission
10. Date of submission
2011-12-28
11. Time period covered by this report
Start date
2000
Time period covered by this report
End date
2011
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is partially in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • No
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • One
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Partially
21. Here you may provide further details on the implementation of Article 2 in your country:
Sri Lanka developped its National Biosafety Framework including National Biosafety Policy under the UNEP-GEF Project on Development of National Biosafety Frameworks. National Biosafety Framework includes five sections, namely; government policy on biosafety, regulatory regime, system to handle notifications or requests for authorizations, mechanisms for public awareness, education and partcipation. system of monitoring and enforcement. National Biosafety Policy got Cabinet approval in year 2005. Regulatory regime has identified some provisions in existing laws that could be used to control, check and even ban introduction of certain Genetically Modified Organsmss (GMOs). It suggest drafting and enacting a new biosafety law  considering all the weaknessess in existing legal framework complying with biosafety policy and regulatory framework.

The only piece of legislation directly related to biosafety at present is Food Regulations 2006. The Ministry of Healthcare and Nutrition developped regulations under the Food Act of 1980, Food (Control of Import, Labelling and Sale of Genetically Modified Foods) Regulations 2006 which has come into effect from January 2007. Food which contains or has genetically modified organisms less than nought decimal five per cent (0.5%) are  exempted from the provisions of these regulations.

The country has drafted a new Biosafety Act, which is at Legal Draftsman at present.

"Guidelines for the Safe Use of Recombinant DNA Technology in the Laboratory" was first published in 2003 and secondly in 2005 by the National Science Foundation.

Laboratory Manual on Detection of Genetically Modified Organisms, Food, Feed and Processed Products was published in 2005.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • No
26. Does your country regulate the contained use of LMOs?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
Regulation of contained use of Living Modified Organisms (LMOs)/GMOs is in the draft Biosafety Act.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • No
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • No
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • No
34. Does your country have the capacity to detect and identify LMOs?
  • Yes, to some extent
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • No
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • No
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
The draft Biosafety Act recognizes that release of an LMO or GMO is undertaken in a manner that prevents or reduces risks to biological diversity and human health and the environment. It requires any exporter to notify the National Competent Authority in writing prior to the transboundary movement of LMOs/GMOs. It is a legal requirement to provide complete and accurate information of all required particulars in the application.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • No
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • None
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • Less than 5
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • None
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • Yes, always
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, but with delays (i.e. longer than 15 days)
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
Food regulations 2006 is the law that regulates GM food items. Food (Control of Import, Labelling and Sale of Genetically Modified Foods) Regulations 2006 came into effect from January 2007. Food which contains or has genetically modified organisms less than nought decimal five per cent (0.5%) are  exempted from the provisions of these regulations. The Act says, no person shall import, store, transport,distribute,sell or offer for sale, any GMO as food for human consumption, any food containing of GMOs or any food produced from ingredients produced from GMOs without approval of Chief Food Authority.

A request was made to import three GM maize varieties for making animal feed for poultry. Risk Assessments were done by three Competent Authorities; Department of Animal Production and Health, Department of Agriculture and Ministry of Health. It was decided not to give permission for import considering the risk assessment reports and global maize market.This decision was given in 2009.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • No
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
Appeals can be made under the draft Biosafety Act  for refusal to issue or renew a permit or suspension or cancellation of a permit after finalization of the Act and when Act is in force.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
The draft Biosafety Act requiers any exporter to notify the National Competent Authority in writing prior to a transboundary movement of any living modified organism or Genetically Modified Organism.The National Competent Authority, if such Authority deems necessary require Sectoral Competent Authorities to carry out risk assessment on a case by case basis.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • No
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • No
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • No
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • None
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • No
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
93. Here you may provide further details on the implementation of Article 15 in your country:
Ministry of Environment is the National Focal Point and National Competent Authority in issues related to biosafety. There are six Sectoral Competent Authorities; Department of Agriculture, Department of Animal Production and Health, Department of Health, Department of Fisheries and Aquatic Resources, Department of Wildlife Conservation, and Ministry of Industries. Risk Assessment Committees are established at these institutes. When National Focal Point recieves an application, it would be forwarded to respective Sectoral Competent Authority or Authorities for a risk assessment.

A Risk assessment was done once regarding a decision on importation of GM Maize as animal feed. A request was made to import three GM maize varieties for making animal feed for poultry. Risk Assessments were done by three Competent Authorities; Department of Animal Production and Health, Department of Agriculture and Ministry of Health.

Risk Assessment processesss for genetically modified plants and products, microorganisms, animals and products are specified in National Biosafety Framework. 

Further, National Biosafety Framework recognizes that entire cost from application to risk assessment and management should be borne by the applicant.

Draft Biosafety Act recognises a similar process. National Competent Authority requires sectoral competent authorities to do a risk assessment if necessary on case by case basis. Final decision would be communicated to the applicant by National Competent Authority.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • No
94.2) LMOs intended for direct use as food or feed, or for processing?
  • No
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • No
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • No
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
National Biosafety Framework has identified Rules to be developped for Risk Management as a priority project.

Draft Biosafety Act recognize, that the sectoral competent authority should prepare the risk management report based on the risk analysis. Decision on an application will be based on the risk assessment and risk management reports.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • No
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • No
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • No
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes, to some extent
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • No
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • No
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
115. Here you may provide further details on the implementation of Article 18 in your country:
National Biosafety Framework provides country specific guidelines for import of genetically modified organisms and products. It gives details on how permits should be. Annex 04 provides Guidelines for internal transport and release of GMOs and products. It provides information needed for reliminary observation, etc.

National Biosafety Policy states, labelling of genetically modified products shall be made mandatory. Compulsory labelling will be required for all products resulting from modern biotechnology, at all stages of the production process, from raw material to final product. It further states that National safety guidelines and implementation practices shall be adopted.

Food (Control of Import, Sale and Labeling of Genetically Modified Foods)  Regulations 2006 under the Food Act of 1980 states inclusion of  Statement "Genetically modified' in approved food products. Approved food products can be placed in the market with apropriate labeling; including statement "genetically modified" either in the package or retail sale.

The draft Biosafety Act has a section on handling, tranportation, packaging and identification of modified organisms. It says National Competent Authority shall have power to make rules in respect of handling, transportation, packaging and identification of any LMO/GMO.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, some information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes, to some extent
123. Here you may provide further details on the implementation of Article 19 in your country:
Ministry of Environment is the National Focal Point and National Competent Authority in issues related to biosafety which liase with the Secretariat. There are six Sectoral Competent Authorities appointed.

1. Department of Agriculture: agricultural and non agricultural (eg. forest species, ornamentals) plants and planting material, microorganisms, and animals, 2. Department of Animal Production and Health: domestic animals including fish, birds and bees, and any other domesticated or wild animals kept in captivity and animal feed, 3. Department of Health: food, 4. Department of Fisheries and Aquatic Resources: all aquatic animals and aquatic plants from zooplankton  and phytoplankton  to higher forms, 5. Department of Wildlife Conservation: all animals except listed tropical aquarium fish and domestic animals , and 6. Ministry of Industries: industrial products.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available but only partially available in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information not available
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available but not in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information not available
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
Sri Lanka recieved the "UNEP-GEF project on building capacity for effective participation in the Biosafety Clearing House" and established the national Biosafety Clearing House, which is http://www.biosafety.lk. Information should be updated at the national web site which would appear in the central portal timely.

Though there were several training programmes conducted on biosafety clearing house, use of it and information updation, still  there is a problem of updating it. There is no staff specifically to deal with biosafety issues and national biosafety clearing house in the competent authorities, so updating information is still a problem.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • No
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • No
134. Here you may provide further details on the implementation of Article 21 in your country:
National Biosafety Policy recognises that, the industries involved in the use of modern biotechnology shall reveal information on organisms used and all other relevant data in order that consumers are aware of the products they are exposed to. Safety test data, especially for agricultural biotechnology and human genetic testing, manipulations and applications, shall be fully disclosed and made public in accordance with legitimate protection of commercially sensitive information.

The regulatory regime in the National Biosafety Framework states that there should be no scope for confidential information. All relevant information should be made available for all the parties.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Multilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Average
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Taking into account risks to human health
  • Risk assessment & management, BCH
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
  • risk assessment, BCH
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
Sri Lanka, in one of the Training Programme on Risk Assessment and Risk Management on GMO/FFPs and use of Clearing House Mechanism of Cartagena Protocol on Biosafety with locall and foreign expertise, specially the International Center for Genetic Engineering and Biotechnology(ICGEB), India generously provided an expert enhancing regional cooperation in capacity building in the region.

Sri Lanka provided an expert as a consultant, assisiting to finalise development of National Biosafety Framework of Maldives.

Sri Lanka implemented the National Biosafety Framework Development project funded by United Nations Environment Program (UNEP)/Global Environmental Facility (GEF) from year 2003 to year 2005. National Executing Agency was Ministry of Environment and Natural Resources. 43 awareness and training workshops were conducted during the project period.Target groups varied from farmers, consumer organizations, Non Governmental Organizations, private sector, government sector, scientists, school children, teachers, teacher trainers, university students, public health inspectors, doctors & lawyers, etc. covering Western, Southern, Central, North-Central, Wayamba, Sabaragamuwa and South Eastern regions. Some of the important workshops were; "Regional Training programme on detection of GMO, FFP" at Biotechnology Center, including members from the South Asia   region, Regional workshop on South Asia and the Cartagena Protocol on Biosafety "Sharing of Experiences with National Biosafety Frameworks" in 2005, "Laboratory safety" programmes for institutional coordinators, Training Programme on Risk Assessment and Management of GMO/FFP in 2004 including regional experts.

National Biosafety Framework Implementation project development started but there was a change in GEF allocations, with the new STAR programme, therefore, it wasnt processed as planned.

Ministry of Environment implemented UNEP-GEF project on effective participation in Biosafety Clearing House from year 2006 to year 2009.A "National Training Programme for Capacity Building of Convention on Biological Diversity and Biosafety Protocol through Clearing House Mechanism", "Training Programme on Risk Assessment and Risk Management on GMO/FFPs & use of Clearing House Mechanism of Biosafety Protocol" are some of the workshops conducted.These workshops were conducted with local expertise and participation of BCH/CP and IT Regional advisors.  In addition to human resources development, institutional strenghtheing was done under the project. Computers and relevent equipment were provided to the six Sectoral Competent Authorities for capacity development.

In addition, several other workshops were conducted by the Ministry of Environment to raise awareness, to train and to identify status of biosafety in the country. Awareness workshops were conducted for school children. "Workshop on Genetically modified foods" on genetically modified food regulations was conducted for relevant officials, focusing mainly Health Ministry when the Food Regulations 2006 came into force.

"National Training Programme on Risk Assessment and Management and Detection of Genetically Modified Foods" was conducted in 2007. "Workshop on Bio-Safety: Status Verification and Risk Assessment at National Level" was conducted in 2009 to establish the baseline on biosafety, need assessment, and for development of skills on Risk Assessment and Management. "Workshop on Biosafety: Risk Assessment and Management of Genetically Modified Organisms, Food, Feed and Processed Products" was conducted in 2010 and 2011 as well."From Green Revolution to Gene Revolution" Biotechnology Regulator/Scientist Conference was conducted with many foreign speakers in 2011.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • No
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • No
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • No
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • No
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
160. Here you may provide further details on the implementation of Article 23 in your country:
One of the objectives of the National Biosafety Policy is to promote public participation in the decision making processes of all matters related to biosafety in order to maintain transparency in the process. Policy principles state, public awareness, education and participation in the decision-making processes shall be made essential for ensuring the judicious use of modern biotechnological applications, practices and products for socio-economic development, without jeopardizing the environment, biodiversity and human health. It further states, public awareness of modern biotechnology and potential risks/benefits, risk assessment and management techniques shall be enhanced, involving the community at large, including policy makers, legislators, administrators, the private sector and biotechnology industries. It further states on labelling, labelling of genetically modified products shall be made mandatory, in order that the demands of consumers for a free and informed choice regarding food are fulfilled.

National Biosafety Framework identifies public participation in decision making process in its regulatory regime.It states, there should be transparency and public-participation in the decision-making process. The material being forwarded to seek approval should be made available for public inspection and comment and a mandatory period for public comments has to be given by law. Regulatory regime too identifies labelling to be mandatory. (Approved food items should be labelled before placing in the market according to Food Regulations 2006).

National Biosafety Framework has a seperate chapter for Mechanisms for Promoting and Facilitating Public Awareness, Education and Participation

The draft Biosafety Act recognize public participation in decision making extensively. A notice will be gazzeted and in one news paper in all three languages for comments on risk asessment and risk management reports, and when a permit is issued. If considered necessary, opputunity would be given for public hearing before decision making.

The national biosafety website is http://www.biosafety.lk. Few workshops have been conducted by the Ministry of Environment to increase awareness on Biosafety Clearing House specifically. Biosafety Clearing House and national web site is presented at several other workshops to increase awareness. 
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
Sri Lanka is a party to the Cartagena Protocol on Biosafety.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • No
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
The draft Biosafety Act mentions about confiscation of LMOs or any product thereof imported in contravention to the Act. Such shall be re exported or destroyed at the expense of importer.

Under the Port Health Office and Air port Health Office, GM certificates are being checked for potential GM food items in importation.

The Ministry of Environment conducted two market surveys for GM food items in year 2009 and 2011.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • No
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
178. Here you may provide further details on the implementation of Article 26 in your country:
The National Biosafety Policy states public awareness, education and participation in the decision-making processes shall be made essential for ensuring the judicious use of modern biotechnological applications, practices and products for socio-economic development, without jeopardizing the environment, biodiversity and human health. Policy statements recognize the importance of protecting its people, environment and biodiversity while promoting a sustainable social and economic development through adopting biosafety measures.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
Sri Lanka plans to sign and ratify the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The National Coordinating Committee on Biosafety has recommended signing and ratification. Consent of Third National Experts Committee on Biological Diversity is to be obtained shortly. A Cabinet note is prepared at present.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, First report only
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Lack of financial resources to gather the necessary information
  • Lack of relevant information at the national level
  • Difficulty in compiling the information from various sectors
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Re: Q. 14 - Sri Lanka signed and ratified the Cartagena Protocol on Biosafety on 24.05.2000 and 28.04.2004 respectively. Protocol entered into force for Sri Lanka on 26.07.2004. 

Re: Q. 136 - Multilateral channels as well.
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2005
Here you may provide further details
Around US$ 30,000.00 was allocated for biosafety activities but actual expenditure was bit less than that.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
Biosafety short term training programmes/academic courses are organised by the Ministry of Environment and Renewable Energy and other institutes as well. Ministry of Environment and Renewable Energy organizes one or two training programmes annually. Rice Research Development Institute, University of Peradeniya, University of Jaffna, University of Ruhuna have conducted workshops. Genetech offers advanced certificate course in gene technology and it also conducts training programmes.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
Hence the Ministry of Environment and Renewable Energy is the National Focal Point it collaborates with the other institutions and provides financial assistance totally or to a certain extent to carry out capacity building initiatives.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • 5,000 USD or more
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Here you may provide further details
Yearly, a portion of the national budget is allocated for biosafety activities.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • No
Here you may provide further details
Risk assessments are done by the Sectoral Competent Authorities. The guidance document produced by the CBD was given to be followed by the risk assessment committees in an ongoing risk assessment.
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • No
Here you may provide further details
Risk assessment reports were not evaluated yet for the given case. Risk assessment is on going.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • No
Here you may provide further details
Risk assessments on feed and products have been done.
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • No
Survey 13.c) Monitor
  • No
Here you may provide further details
It is expected to develop the capacity through a UNEP-GEF funded project which is at the project identification format formulation stage.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • No
Here you may provide further details
Draft Biosafety Act recognize developing rules for handling, transportation, packaging and identification of living modified organisms/genetically modified organisms.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
Draft Biosafety Act facilitates public participation in decision making. The risk assessment and risk management reports are published in the gazette and in news papers in three languages for public comments. Public hearing will be facilitated if considered necessary according to the draft act.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • None
Here you may provide further details
Socio economic considerations in draft biosafety act was developed considering existing laws involving public participation specially the National Environment Act.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
-
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • No
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • 100 or more
Survey 19.b) Monitoring
  • None
Survey 19.c) Management / Control
  • 100 or more
Here you may provide further details
Training on risk assessment and risk management of genetically modified organisms, food, feed and processed products was conducted in 2004 including regional experts. In 2007 risk assessment and risk management, detection of genetically modified foods, in 2008 risk assessment and risk management and use of clearing house mechanism including regional experts were conducted. In 2009, 2010 and 2011 workshops on risk assessment and risk management of genetically modified organisms, food, feed and processed products were conducted.
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
Few laboratories have been identified. Further capacity building needs to be done.
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
Training material provided in the biosafety clearing house central portal were used.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • No
Survey 22.b) Effective
  • Yes
Here you may provide further details
Further guidance material required.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
Custom officers were included in the risk assessment and risk management workshops held.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
One workshop has been conducted in 2007. "Laboratory safety" programmes were also conducted.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
Currently a private organization is conducting GM detection. Universities have the capacity to undertake GM detection if funds are provided and further capacity built.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • None
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • None
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • No
Here you may provide further details
A separate law has to be drafted.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • No
Here you may provide further details
In awareness and training workshops, the proposed procedure in the draft act is described.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • Not relevent
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • One or more
Here you may provide further details
Genetech, University of Peradeniya, University of Rajarata, University of Kelaniya, Eastern University of Sri Lanka, Wayamba University of Sri Lanka, University of Sabaragamuwa,  and University of Uwa Wellassa offers such programmes. There's is only one post graduate course that deals with biosafety directly. Other courses that explain production of transgenics do not cover biosafety adequately.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • None
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • No
Survey 35.b) Enforcement system
  • No
Here you may provide further details
New Biosafety act is at the final stages of development at the Department of Legal Draftsman's at present.
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • One or more
Here you may provide further details
Two workshops have been conducted at national and international level (with international experts).
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • One or more
Here you may provide further details
Biosafety Policy in three languages and the text of Supplementary Protocol on Liability and Redress in native language have been made available since 2011.
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • Printed books were the publication method, but publishing on line (national web site) was also preferred.
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
more than 50 awareness workshops/ training programmes have been conducted so far.
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
The government is responsible mainly. Other institutes collaborate with the government for such programmes. Some semi government institutions like National Science Foundation, private organizations like Genetech has also conducted awareness/training workshops. Both national and international level workshops have been conducted.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more
Here you may provide further details
Leaflets on biosafety