Since Lao PDR has become a party of the Convention on Biological Diversity on September 20, 1996 and the Cartagena Protocol on Biosafety on November 1, 2004. The Lao government is obliged to develop its national regulatory framework in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology for reducing potential consequences that may have an adverse effect biological diversity and human health. Laos has participated in a UNEF/GEF funded project to develop National Biosafety Framework (NBF). The NBF has been developed since 2002 and was adopted by the government on December 25, 2004. It consists of a combination of policy, legal, administrative and technical instruments that are set in place to address safety contains of six components including the government policy on Biosafety, the regulatory regime for Biosafety, administrative systems for Biosafety, mechanism for public education awareness and participation, capacity building programs to implement CPB and project priorities to implement the NBF.<br /><br />This NBF was also used to prepare a Biosafety Law Draft which was introduced initially at the Lao Government Meeting on August 30, 2005 based on the comments from Ministry of Justice on 18 July 2005. The Law then adopted by the National Assembly on 18 December 2013, ref No. 017/NA and promulgated by the president of Lao PDR, Ref No. 058/PO, dated 28 January 2014. The law defines the principles, regulations and measures on management and monitoring of biotechnology safety to ensure safety in research, development, handling, movement, and the use of Genetic Modified Organisms (GMOs) resulting from the use of biotechnology, which may result in having negative impacts on conservation and sustainable use of biodiversity, with a focus on the limitation and reduction of risks to the life and health of human beings, animals, plants and the environment that can be linked at the regional and international levels, and which contribute to national socio-economic development.<br /><br />The law is a significant indication which illustrates the country efforts on its commitment on the Cartagena Protocol. Since new decisions have been agreed by the Parties at the COP/MOP meetings of 2006 and 2008, the Biosafety regulations need to revise to be in-line with these COP/MOP decisions and also to be supported by drafting appropriate secondary and tertiary instruments. During this reporting period, contained use, food and feed and environmental release regulations are in the process of reviewing from the Ministry of Justice before sending the draft regulations to the National Biosafety Committee for adoption based on the Biosafety Law (2014). In addition, Biosafety Guideline, Administrative Task and Handling Application are drafted in order to support the law implementation and Biosafety in the nation. <br />

The drugs and medical products imported for distribution in the Lao PDR shall be subject to registration or notification with the Department of Food and Drug of the Ministry of Health. This is clearly identified in Law on Drugs and Medical Products, No.07/NA, dated 21 December 2011. <br /><br />Laos does not have a single regulation of transboundary movements, handling and use of living modified pharmaceuticals. Biotechnology and Safety Law is only available regulation in the country dealing with genetic modified organisms. The law scope is to individuals, legal entities, and domestic and international organizations working or operating in regard to Biosafety. It does not apply to medicines made from GMOs. <br /><br />As the country is a member of Association of South-East Asian Nations (ASEAN). It follows an ASEAN pharmaceutical agreement which is called ACCSQ Pharmaceutical Product Working Group. Under the agreement ASEAN Common Technical Requirements (ACTR) and Common Technical Dossier (ACTD) are applied to risk assessment prior to making of decisions on import genetic modified medicines such as human insulin and hepatitis vaccine B.<br />

No such decisions have been taken during the report period regarding to transit and contained use of LMOs.<br /><br />In Biosafety Law, National Biosafety Committee (NBC) and Technical Coordination Committee (TCC) should be established in order to deal with the national biosafety activities. NBC should be designated by the Prime Minister and TCC should be adopted by the NBC Chair. The committees are in the process of government consideration. NBC plays a very significant role on instruction, making decision, guidance and adoption of biosafety regulations, manuals,&nbsp; technical guidelines and other concerns.

Biotechnology Safety Law was enter into force in 2014 that biosafety committees, secondary biosafety regulations and technical guidelines are in the process of improvement and adoption by the government. The law is an outstanding result for implementing of National Biosafety Framework (INBF). The INBF project was funded by the UNEF/GEF from 2009 to 2014. The project has provided capacity to establish GMO Detection Lab at Biotechnology and Ecology Institute, Ministry of Science and Technology. Trainings and Technical Supports was included in the project activities to enhance the capability of technical staffs who are working on risk assessment, risk management, inspection and monitoring and LMO detection. <br /><br />However, there is no sufficient, for instance: only qualitative analysis was trained by the&nbsp; international expert in the hands-on training on detection of genetically modified organism. Some cases of GMO testing and certification has operated in terms of supporting the country biosafety activities. Ministry of Science and Technology have contacted with UNEP for accessing GEF funding support to strengthen the risk assessment and risk management on GMO capacity. This regional project is in the process of consulting with stakeholders and submitting project proposal to the donors. <br /><br />Overall, no such decisions have been taken on applications/notifications regarding international transboundary movements of LMOs for international introduction into the environment. This is because of Laos has not been a country of import and export of LMOs for the purpose of international release into the environment during the reporting period.<br />

Laos has not been gone through applications or final decision for the purpose of domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed or for processing into the country, so we have no experiences in the implementation of the Article 11. <br /><br />Domestically, Regulation on the Control on Production, Exported-Imported Safe Food was created in 2006 which purposes to define principles, rules, measures for production, processing, import, export and distribution of food in the country. National Food Safety Policy was later adopted by the government with involvement of concerned government agencies such as Ministry of Health, Ministry of Agriculture and Forestry, Industry and Commerce, Finance, Information and Culture, Education, Social Security, Science and Technology, Environment and local sectors that are related to food chain for protecting consumer's safety and health. The policy development was also based on the globalization of food trade, including the implementation of international and regional trade agreements. At the same time, the requirements of the Sanitary and Phytosanitary (PPS) and Technical Barriers to Trade (TBT) agreements of WTO create also obligations requiring the safety of food traded internationally in order to protect the sovereign rights of the member nations. This means increasingly important to identify the potential risks and benefits of these changes and to prevent adverse human health and economic consequences. Decisions of Ministry of Health Minister was also issued in 2009 on Food Labeling and Packing, No. 519/MOH in order to apply in processing, import, export and market introduction. <br /><br />The National Consumer Protection Law has been implemented in 2010 by the Ministry of Industry and Commerce that food importers must be gone through all processes requested by the concerned stakeholders to ensure consumer and environmental safety. Moreover, it requires also labeling of commodities which will be placed into markets nationwide. This clearly appear in part II, Article 13-20. In 2013, Law on Food 06/NA was after that amended that basic principles on food is given additional from the previous including safety, healthy and meet the demands of international food standards, and international treaties and protocols that the country becomes parties. Operation measures are applied to ensure food safety such as application for registration of food, imported permit and certificate of registration for food imports.&nbsp;&nbsp; <br />

Lao PDR has not been gone through review of decisions any international transboundary movements of LMOs, so we have no experiences in the implementation of Article 12.&nbsp; &nbsp;&nbsp;

No simplified procedures has not been adopted by the government for implementing Article 13 in the Biotechnology Safety Law. However, the simplified procedures is under consideration that intentional transboundary movement should or should not take place at the same time as the movement is notified to the Party of import.&nbsp;

Lao PDR has not joined bilateral, regional and multilateral agreements and arrangements concerning the implementation of Article 14.

Lao PDR conducted the National Project of Implementation NBF that funded by the UNEF/GEF from 2009 to 2014. The project provided basic facilities like a real time PCR&nbsp; for conducting GMO detection at Biotechnology and Ecology Institute, Ministry of Science and Technology.

Referring to question 100 above, the answer given is No because there is no specific emergency respond team on LMO exist, however in case an unintentional release of LMOs, some capacity should be available with involvement of concerned sectors such as Ministry of Agriculture and Forestry, Ministry of Health, Ministry of Science and Technology and Ministry of Natural Resources and Environment. Based on the Biosafety Law, National Biosafety Committee (NBC) plays the role also planning, reviewing and adopting the biosafety regulations and guidelines as well as leading the measures of unintentional transboundary movement and emergency response. Therefore, the NBC needs to be urgent established in order to move forward the biosafety activities. <br /><br />Emergency measures is also found in the draft Food and Feed Biosafety Regulation where&nbsp; suspension of the placing on markets or use of the food or feed in question; and laying down special conditions for food or feed in question are appeared in order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.&nbsp; <br />

LMO Detection Lab was established under the support of the INBF project which assisted by the international experts from the Environment Agency Austria in 2014. Some GM testing activities (random from local markets and GMO certification) has operated based on available facilities and human resources. The lab is certified by the national standard. <br /><br />Decisions of Ministry of Health Minister was also issued in 2009 on Food Labeling and Packing, No. 519/MOH in order to apply in processing, import, export and market introduction. Law on Food was adopted and amended in 2013 that provide basic principles on food including safety, healthy and meet the demands of international food standards, and international treaties and protocols that the country becomes parties. <br /><br />Labeling requirements on LMOs is drafted under the FFP regulation and under the development and adoption process. The regulation indicates that granted approval by the National Competent Authority and NBC should be made before place any LMO on the market.&nbsp; <br />

In order to implement the Biotechnology Safety Law, NBC is&nbsp; under the process of asking permission and adoption by the government. The NBC should be assigned by the Prime Minister, while TCC is appointed by NBC Chair. <br /> <br />

Mechanism of coordination and administration of the BCH responsible team must be improved and adopted by the National Biosafety Committee for effectiveness of information and experience exchanges.

Further confidential system should be created and adopted by the National Biosafety Committee in order to protect the applicant rights and interests on the trade and security information.&nbsp;

Human resource development is one priority works for the government which indicates research and development in the Article 8-18 of the Biotechnology Safety Law. A good example is Biotechnology and Biosafety issues has introduced in a study curriculum for university students. In addition, science and technology will become a development tool to support the country to meet the demand of sustainable social-econimic development and poverty reduction to 2030.<br /><br />However, increasing support to fulfill the protocol obligations is necessary which include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety.&nbsp; <br />

No such decisions have been taken during the report period and the decision making process has not been adopted by the National Biosafety Committee yet.

Biotechnology Safety Law was just adopted and entered into force in the country since 2014. Next step is establishing sub-regulations and guidelines to support the implementation of the law and building capacity in the field is also necessary. Some further details is also provided in the question 185 above.

In general speaking, the government often includes social and economic consideration into account in development programes. This is also identified in the objective of Biotechnology Safety Law concerning the impact of living modified organisms which may result in having negative impacts on conservation and sustainable use of biodiversity, with a focus on the limitation and reduction of risks to the life and health of human beings, animals, plants and the environment that can be linked at the regional and international levels, and which contribute to national socio-economic development. <br /><br />In addition, using the existing operating measures is considered for further work on biosafety activities such as import certificate for plants and plant products, import permit and plant quarantine declaration under its domestic measures implementing the environment introduction. This procedures can take into account consistent with the national obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities. <br />

As a member of ASEAN, WTO, WHO, FAO, CBD, CPB, ITPGRFA and other international treaties and convention, Lao PDR has cooperated with other parties on research, development and information exchange on socio-economic consequences related benefits and risk by using modern biotechnology.&nbsp; &nbsp;

Laos is not yet ratify the Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress. However, Liability and Redress Regulation is consulted and drafted as a result of the INBF project for supporting the Biotechnology Safety Law. This issue needs to have further development and consultation among relevant stakeholders before introducing to the government for consideration.&nbsp;

Laos has not been gone through applications and decisions for the purpose of food, feed, processing, environment release and contained use for both import and export into the country, so we have no experiences in the national implementation of the protocol. A challenge for the government is that Biotechnology and Biosafety being new issues, awareness among policy makers and public are limited. The public still has not sufficient information and understanding for active involvement to the procedures of making decisions.&nbsp; <br /><br />The official adoption of the Biosafety Law No. 017 from National Assembly was on 18 December 2013 and Promulgation of the president No. 058/PD was on 28 January 2014. The law was drafted by the international consultant with inputs by the project team and stakeholders, but the process of government consideration and public consultation took very long to develop and approve the bill. Monitoring and Enforcement remains challenges due to the human resources, funds and facilities dealing with the issue. NBC and NCC has not yet established to facilitate the biosafety activities in the country. Carry on activities especially risk assessment, risk management and enforcement should be designed and follow up for continuous works. In addition, resource mobilization mechanism should be created in order to meet the sustainability means. <br />

No difficulties have been encountered in answering this report questions because they are based on the articles in the Cartagena Protocol on Biosafety. This is also the second report for submitting to CBD, so it is more understand than the previous. Moreover, some activities and information are available at the time filling this report especially the country has just adopted the Biotechnology Safety Law which is an outstanding output from the INBF project. <br /><br />However, there is a limitation of information technology in filling answers in the report due to a fixed format provided. For example, spelling check and adjust the format are also providing difficulty to fill the report in the word file. <br />