Sri lanka developed its national Biosafety framework including National Biosafety Policy&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; under the UNEP-GEF Project on Development of National Biosafety Frameworks. National Biosafety Framework includes five sections, namely:Governement policy on Biosafety regime, system to handle notifications or requests for authorizations, mechanisms for public awarness, education and participation, system of monitoring and enforcement. National Biosafety Policy got Cabinet approvel in year 2005. Regulatory regime has identified some provition of certain Genetically Modified Organsmss (GMOs). It suggest drafting and enacting new biosafety law considering all the weeknessess in existing legal framework complying with biosafety policy and regulatory framework.<br />The only piece of legislation directly related to biosafey at present is Food Regulations 2006. The Ministry of Healthcare and Nutrition developed 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. <br />The Country has drafted a new Biosafety Act, which is at Legal Draftsman at present.<br />"Guidelines for the Safe Use of Recombinant DNA Technology in the Laboratory " was first published in 2003 and second ly in 2005 by the National Science Foundation. <br />Laboratory manual on Detection of Genetically Modified Organisms, Food, Feed and Processed Products was published in 2005.

Regulation of contained use of Living Modified Organisms (LMOs) / GMOs is in the draft Biosafety Act.

The draft Biosafety Act recognizes that release an LMO or GMO is undertaken in a manner that prevents or reduces risk to biologicla 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 requirment to provide complete and accuarente information of all required particulars in the application.

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&nbsp; 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. <br />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.<br />The request was made by Ministry of Health in 2013 to import MOUSTIcide to counduct dengue control pilot project in Gampaha District. Risk assessments were done by Ministry of Health, Ministry of Agriculture, Department of Animal Production and Health, Department of Fisheries and Aquqtic Resources.Thr risk assessments team was asked provided furthe details to the Mnistry of Health to make the decision.<br />The reserch proposal was submitted by Industrial Technology Institute to determine environmentl friendly and efficient vector control strategies including novel control agents in controlling dengue vector mosquitoes.One such spp is Wolbachia bacteria.The members of the National Biosafety committee in Sri Lanka was decided to grant approvel to import Wolbachia bacteria from Australia, only for laboratory testing for research purposes and once the outcome is determined from laboratory testing, committee will decide in future to proceed eith confine field trials and large scale applications.This decision was given in 2015.<br />Strentherning of decision making process in sectrol Competent Authorities is further needed requirement.&nbsp;&nbsp;

Appeals can be made under the draft Biosafety Act&nbsp; 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.

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 15- 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.&nbsp; <br />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. <br />Risk Assessment processesss for genetically modified plants and products, microorganisms, animals and products are specified in National Biosafety Framework.&nbsp; <br />Further, National Biosafety Framework recognizes that entire cost from application to risk assessment and management should be borne by the applicant.<br />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<br /><br />Article -16 - National Biosafety Framework has identified Rules to be developped for Risk Management as a priority project.<br />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..

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.<br />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.<br />Food (Control of Import, Sale and Labeling of Genetically Modified Foods)&nbsp; Regulations 2006 under the Food Act of 1980 states inclusion of&nbsp; 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.<br />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.

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.<br />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&nbsp; and phytoplankton&nbsp; 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. <br />

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 <a href="http://www.biosafety.lk">http://www.biosafety.lk</a>. Information should be updated at the national web site which would appear in the central portal timely. <br />Though there were several training programmes conducted on biosafety clearing house, use of it and information updation, still&nbsp; 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.

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.<br />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. <br />

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. <br />Sri Lanka provided an expert as a consultant, assisiting to finalise development of National Biosafety Framework of Maldives.<br />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 &amp; 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&nbsp;&nbsp; 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.<br />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. <br />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 &amp; 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.&nbsp; 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.<br />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. <br />"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.

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. <br />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).<br />National Biosafety Framework has a seperate chapter for Mechanisms for Promoting and Facilitating Public Awareness, Education and Participation<br />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.<br />The national biosafety website is <a href="http://www.biosafety.lk">http://www.biosafety.lk</a>. 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.<br /><br />Q. 169: Newspapers included

Sri Lanka is a party to the Cartagena Protocol on Biosafety.

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.<br />Under the Port Health Office and Air port Health Office, GM certificates are being checked for potential GM food items in importation.<br />The Ministry of Environment conducted two market surveys for GM food items in year 2009 and 2011.&nbsp;

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.

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.