Malaysian Biosafety Act entered into force on 1 December 2009. This Act complements the National Policy on Biological Diversity (2016 – 2025) and covers only modern biotechnology activities. The objective of the Act is to protect the health and safety of people, animals, plants, the environment and biological diversity by regulating the release, importation and contained use of Living Modified Organisms (LMOs) and/or the release of products of such organisms. The Ministry of Water, Land and Natural Resources is the National Focal Point for the Cartagena Protocol on Biosafety. The National Biosafety Board (NBB) makes decisions on LMOs activities in Malaysia. A committee called the Genetic Modification Advisory Committee (GMAC) was established in May 2010 to provide scientific, technical and other relevant advice to the NBB. The Department of Biosafety which was set up to be the focal point of all biosafety related activities in Malaysia carries out such duties as envisaged by the NBB. There are 3 Regulations under this Biosafety Act. Biosafety (Approval and Notification) Regulations 2010 was enforced on 1 November 2010. In 2018, two new regulations were gazetted to strengthen the implementation of the Biosafety Act. The Biosafety (Sampling Procedures) Regulations 2018 establishes specific procedures to be followed when taking sampling for the purpose of enforcement whereas the Biosafety (Compounding of Offences) Regulations 2018 allows compounding of certain acts of non-compliance under the legislation. The Department of Biosafety has completed the Standard Operating Procedure (SOP) for sampling and enforcement but the SOP for compounding of offences is still in progress. Even though some policies and legislations don’t explicitly deal with LMOs per se, it is applied to handle LMOs and its products. Some local research facilities and universities that deal with modern biotechnology have also incorporated biosafety at their institutional policies, rules and regulations.

The Malaysian Biosafety (Approval and Notification) Regulations 2010 states that there is no need to get approval or notify the National Biosafety Board for pharmaceutical products of LMOs which are addressed by relevant international treaties or organisations, or regulated under any other written laws relating to pharmaceuticals. There are two key elements to be fulfilled under this category for the exemption to apply - 1) It must be a pharmaceutical product of LMOs; and 2) It must be: i. addressed by relevant international treaties; or ii. addressed by relevant international organisations, or iii. regulated under any other written laws relating to pharmaceuticals. However, the production of human and animal pharmaceutical products of LMO are still regulated by the Malaysian Biosafety Act 2007. The trial phase of using locally developed human pharmaceutical products of LMO is regulated by National Pharmaceutical Regulatory Agency (NPRA), whereas the trial phase of using for locally develop animal pharmaceutical products of LMO is regulated by the Department of Veterinary Services.

Contained use activities involving LMOs are regulated under the Malaysian Biosafety Act. "Contained use" means any operation including research and development, production or manufacturing operation involving LMOs, or storage of LMOs, undertaken within a facility, installation or other physical structure such that it prevents the contact and impact of the LMOs on the external environment. This implies two things: one is that there has to be a physical structure and secondly, the physical structure must be such that there will be no contact of the LMO with, and no effect of the LMO on the external environment. The various classes of containment are specified in the Regulations as four levels of Biosafety Containment Levels (BSL) as based on existing international approaches to handling pathogenic organisms. The BSL dictates the minimum level of containment required for carrying out activities with LMO and related materials originating from these organisms. However, in the case of an LMO, a risk assessment should be done to determine the BSL required to handle the LMO. Guidance on requirements, facility specification and work practices of the various containment levels is provided in the Biosafety Guidelines for Contained Use Activity of Living Modified Organism. Transit of LMOs is not regulated under the Malaysian Biosafety Act.

Export and import of LMOs are regulated under the Malaysian Biosafety Act. Anyone who wants to export LMOs must first notify the National Biosafety Board to do so. The person must comply with the requirements of the importing country and must inform the NBB of such requirement and provide evidence that these requirements have been met. The export can commence once the acknowledgement of receipt of notification is issued by the Department of Biosafety. This however, is still subject to the requirements of any other local legislations that regulate export. A simplified process in the form of an exemption is given for an export of an LMO to the same country, with the same LMO for the same purpose and by the same approved person requires a Notification only once. There is no need to submit a further notification for any subsequent export of the same LMO where an acknowledgement of receipt is given. As for import, anyone wishing to import LMOs or product of LMOs into Malaysia must have approval to do so. The type of approval necessary will depend on the intended use of the LMO that is imported. Decisions on approval for import must be conveyed to the notifier. All decisions made after the enforcement of the Malaysian Biosafety Act have been uploaded to the Biosafety Clearing House.

Under the Malaysian Biosafety Act, "release activity" means any intentional introduction of LMOs or products of such organisms into the environment through the activities or for the following purposes - i) Research and Development purposes in all field experiments; ii) Supply or offer to supply for sale or placing on the market; iii) Offer as gift, prize or free item; iv) Disposal; v) Remediation purposes; and vi) Any other activity which does not amount to contained use. In this context, domestic use, including placing on the market of LMOs-FFP is subject to the law. An approval must be obtained before it is released. However an Exemption has been given for products that have already been given an Approval for the purpose of food, feed and processing. Subsequent use of the approved product for the purpose of food, feed and processing by any other person is exempted from getting an approval. As of 30 September 2019, Malaysia has approved 38 LMOs-FFP.

The National Biosafety Board may, in consultation with Genetic Modification Advisory Committee, review any decision at any time upon obtaining new information or evidence on the LMOs or products of such organisms that have already been approved. This includes decisions for both release and contained use activities. If the National Biosafety Board is convinced that there is a risk posed to human, plant or animal health, the environment or biological diversity, the National Biosafety Board may take any of the following actions: (i) revoke the approval; (ii) make a temporary cessation order; (iii) make a cessation order; (iv) impose additional terms and conditions; (v) order the approved person to make rectifications; or (vi) make any other order as the National Biosafety Board thinks fit in the interest of biosafety. On the other hand, any applicant or approved person aggrieved by a decision of the National Biosafety Board may either appeal to the Minister, or request for variation in the case of terms and conditions imposed on the certificate of approval. After a request for review is made based on new information or scientific evidence received, this information is initially assessed by Genetic Modification Advisory Committee with reference to the risk assessment relating to the decision. If Genetic Modification Advisory Committee is convinced that the "new risk" has not been addressed, then the request will be further processed for a review of decision by the National Biosafety Board.

The Minister has a power to make a direct exemption under the Malaysian Biosafety Act. These exemptions include: 1) any LMO event that has been approved for FFP, may be used for subsequent processing without seeking an approval again; 2) an export of LMOs to the same country, with the same LMOs for the same purpose and by the same approved person only requires a Notification once.

Malaysia has not entered into any bilateral, regional or multi-lateral agreements or arrangements as per the provisions of Article 14 during the reporting period.

It is mandatory to conduct a risk assessment and develop risk management plan under the Malaysian Biosafety Act before any decision is made for LMO related activities. The Genetic Modification Advisory Committee (GMAC) has been appointed under the Malaysian Biosafety Act to conduct a risk assessment and advise the National Biosafety Board (NBB). Besides locally developed guidelines, GMAC refers to: (i) CODEX Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants; and (ii) Guidance on Risk Assessment of Living Modified Organisms (developed by the AHTEG on Risk Assessment and Risk Management) when making their assessments of LMOs particularly for the purpose of food, feed and processing. In addition, relevant biology documents produced by Organisation for Economic Co-operation and Development (OECD) and Office of the Gene Technology Regulator Australia (OGTR) are referred to as well. Malaysia has produced its own biology document on papaya that has been used for risk assessment. A procedure is established for applying risk management conditions to LMOs in containment as well as for release/field testing. Upon completion of risk assessment for any activity, additional risk management strategies may be incorporated as conditions to the applicant. A post release monitoring period may also be imposed for the purpose of ensuring that any unintentional adverse effects are addressed, if any. In terms of training, several risk assessment and risk management workshops were conducted mainly targeted researchers and academicians and to date nearly 100 people have been trained. Even though there is an increased awareness about risk assessment and risk management, the expertise has been built only for a limited group of people and there is a pressing need to increase the number of people with this expertise to implement biosafety regulatory activities effectively. The Institutional Biosafety Committees of the research institutes, universities and industries play a fundamental role in organising trainings for their researchers at the institutional level to raise awareness and encourage compliance to the Malaysian Biosafety Act.

During the reporting period, there were no known occurrences under Malaysian jurisdiction that led, or could have led, to an unintentional transboundary movement of a LMO that had, or could have had, significant adverse effects on the conservation and sustainable use of biological diversity and/ or human health. If there is a case of unintentional transboundary movement of LMO, a reference will be made to existing guidelines produced by other agencies. For example, there is an emergency response plan mechanism in place to address non-GM invasive alien species produced by the Department of Agriculture Malaysia that may be used and adopted accordingly for addressing emergency measures in case of unintentional transboundary movements of LMOs.

The domestic legal framework for handling of LMOs is already in place in Malaysia. However, more interagency coordination, capacity building and awareness activities are needed before this can be fully operationalized. For example, on transport and packaging, only LMOs destined for contained used activities are provided with detailed explanation on the procedures for packaging and transport of LMOs. These LMOs are tabulated according to its type as stated in the Biosafety Guidelines for the Contained Use Activity of LMOs. In addition, efforts are ongoing to link related regulatory documentations under other existing written laws for identification of LMOs. The Department of Biosafety lacks capacity and facilities to conduct detection of LMOs on its own. However, there are a few laboratories with facilities for the detection of LMOs and the Department of Biosafety has access to these facilities to obtain their services. In 2016, the National Public Health Laboratory provided screening services for LMOs. Subsequently in 2018, another two more laboratories were added - the Forest Research Institute of Malaysia and Food Safety and Quality Division Laboratory to assist in initial screening for detection and identification of samples. In early 2019, Miri Health Laboratory started to provide services to process samples taken in Sarawak, Sabah and Federal Territory of Labuan. However only the Department of Chemistry Malaysia has the expertise and accreditation for detection and identification of LMOs and has been appointed as an analyst under the Malaysian Biosafety Act to process the samples obtained for the purpose of enforcement. In the last four years, a few training workshops on LMO identification and detection had been conducted with the objective to raise awareness to enforcement officers about the identification and documentation of LMO, and also the techniques/ methodologies that may be used for the implementation of these requirements. Despite all the activities conducted so far, continuous priority is very much needed to increase technical capacity in this area with appropriate financial and expertise support in place.

The Ministry of Water, Land and Natural Resources (KATS) is the National Focal Point for the Cartagena Protocol on Biosafety. The National Biosafety Board (NBB) is the decision making body under the national law while the Genetic Modification Advisory Committee (GMAC) provides advice on scientific and technical matters in particular on risk assessment and risk management. The Department of Biosafety which is formed under the Malaysian Biosafety Act as the competent national authority and also secretariat to the NBB and GMAC. NBB has been established since 15 March 2010. The Chairman of the NBB is the Secretary General of KATS and its members comprise of representatives from Ministry of Health Malaysia, Ministry of Agriculture & Agro-Based Industry, Ministry of Energy, Science, Technology, Environment & Climate Change, Ministry of International Trade and Industry, Ministry of Primary Industries, Ministry of Domestic Trade and Consumer Affairs and four other persons with knowledge and experience in disciplines or matters relevant to the Malaysian Biosafety Act. GMAC was formed on 25 May 2010 during the first meeting of NBB. Members of GMAC consist of experts from various science-based and other relevant disciplines working with Government agencies, research institutes, private sectors and Non-Governmental Organizations (NGO). In the year 2017, a Technical Committee for Monitoring of Living Modified Organism (JTP-LMO) was formed that is chaired by the Secretary General of the Ministry of Water, Land and Natural Resources. JTP-LMO is an integrated committee at the administrative/officer level for the purpose of coordinating and implementing LMOs monitoring and enforcement. The Working Group on LMO Analysis was set up in 2018 to coordinate detection work done by the analysts from the various laboratories that are working together with the Department of Biosafety.

Decisions by a Party regarding import of LMOs for contained use (Article 6, paragraph 2) is available to the competent authority but not disclosed to general public following the request by the main stakeholders. The contained use activities involving LMOs are mostly research and the stakeholders do not want any information about ongoing research to be made available for public access at that phase of development. There are also contained use activities for commercial production that utilizes LMOs as part of the process and due to commercial interest of these activities, it is not made available for public access.

Malaysia has always strived to provide the stakeholders and public with a reliable reference point to get information on activities and current issues on biosafety to build confidence, ensure transparency and have open communication besides ensuring a smooth transition towards implementation of the Malaysian Biosafety Act. In accordance with Article 20, Malaysia has provided all necessary information in the national Biosafety Clearing House. The official website of the Department of Biosafety (www.biosafety.gov.my) provides the avenue for information dissemination and it is under the management of the Department of Biosafety. The Department of Biosafety is active on social media whereby it maintains a Facebook page (Department of Biosafety Malaysia) and a Twitter account to disseminate information on its activities. Information sharing is vital in Malaysia to convey accurate information about the national biosafety legislation as well as the Protocol and biosafety in general for the purpose of raising awareness and giving unbiased information to all stakeholders and the public. Biosafety-related events at the national level or State levels have been organized by the Department of Biosafety. However, various local institutes have also organized some biosafety related events and helped to raise awareness about biosafety.

The information that is granted confidentiality should not be disclosed except for the purposes of any civil or criminal proceedings under any written law or where otherwise authorized. For both application and notification, the applicant would be reminded to indicate the information which should be treated as confidential. Handling of these confidential information/documents is subject to the Malaysian Official Secrets Act and also under a specific provision under the Malaysian Biosafety Act. This provision is consistent with the provision of the World Trade Organization.

Malaysia has been carrying out capacity building activities in biosafety since 1997. However these activities are spread thinly across various institutes and universities. After the mandatory requirement to set up the Institutional Biosafety Committee in research institutes was implemented in 2010, training was focused for these institutes to assist and guide researchers in being compliant to the requirements of the Malaysian Biosafety Act. It has been well recognised that successful implementation of the Protocol is contingent on the development of continuous biosafety capacity building activities at par with the technology which is growing and evolving very rapidly. To keep pace with the developments in the field of biotechnology as well as associated safety concerns, capacity building for various stakeholders in different areas becomes important. In its efforts to build scientific capacity to monitor longer-term impacts on environment, human health and biodiversity through a risk management programme, the Department of Biosafety is planning to develop infrastructure and establish mechanisms to facilitate the coordination, collection and storage of data for the better inter-sectoral information sharing, exchange and data management. This will enable the Department of Biosafety to facilitate the smooth management and supervision of LMOs in this country. Capacity building had been provided for enforcement and laboratory officers to enhance good governance and increase competency in regulating LMOs into the country especially to the Malaysian Quarantine and Inspection Services (MAQIS) Department and Department of Agriculture (DOA), Sabah and Sarawak. Participants had been trained according to the Regulations and Standards. Malaysia obtained some allocations under GEF funds (for focal area biodiversity) for a biosafety capacity building project. The project title is Institutional Capacity to Enhance Biosafety Practices in Malaysia and was signed between UNEP and Department of Biosafety Malaysia in November 2018. The main objective of the project is to strengthen the biosafety management system in Malaysia with special emphasis on thematic interventions to facilitate handling and decision making on LMOs. The project was started in November 2018 and shall be completed in November 2022 (4 years). The main components are (i) Risk and socio economic assessment with related management framework (ii) Framework for handling LMOs (iii) Institutional capacity building (iv) Biosafety communication framework. This project will assist Malaysia, as Party to CPB, to meet its obligations by building on and strengthening existing national capacity to fulfill commitments under CPB especially in critical areas such as risk assessment and management, handling, transport, packaging and identification of LMOs and socio economic consideration in decision making.

The Department of Biosafety published education kits, flyers and posters in different languages for different target groups on issues of biosafety. National level biosafety events were organized to gain more visibility. In addition, the Department of Biosafety also utilized events organized by other agencies and introduced the biosafety component. For example, the Department of Biosafety set up an exhibition booth in Malaysia Agriculture, Horticulture and Agrotourism Show (MAHA 2019) to engage the public who visited this event. In addition, awareness events were also organized in Sabah and Sarawak. On public participation, it is a requirement under the Malaysian Biosafety Act for the National Biosafety Board to consider inputs/comments received from public during consultation period when making its decision for application of release activities of LMOs. Malaysia has developed a guideline on how to make an announcement to invite the public to participate in this process.

During the period of reporting, Malaysia has approved the import of LMO for direct use as food or feed, and processing (FFP) from non-Party. Malaysia has also approved export of LMOs for contained use activities both to Party as well as non-Party.

The Malaysian Biosafety Act prohibits persons from carrying out activities involving LMOs (release, importation, exportation, contained use) or products of such organisms unless they have obtained prior approval (for release into the environment) or provided notification (for all other activities: export, contained use or import for contained use) in accordance with the Malaysian Biosafety Act. The legislation establishes offences for unauthorized activities. The penalties for unauthorized activities are: • Individual - Fine not exceeding RM250,000 and/or imprisonment not exceeding 5 years; • Body corporate - Fine not exceeding RM500,000; • If the offence is a continuing offence - further fine not exceeding: o RM 10,000 for individual; o RM 20,000 for body corporate; for each day the offence continues after conviction. During the period of reporting there has been no occurrence of illegal transboundary movement of LMO, which has been brought to the notice of the Government.

The Malaysian Biosafety Act provides for socio economic considerations to be part of the decision making and the National Biosafety Board has used this provision in some cases. Under the new GEF funds allocated for capacity building, funds have been allocated to develop the component of socio-economic considerations in decision making. These activities were discussed during the Inception Workshop of the project that was held on 3-4 April 2019. The activities are scheduled to be conducted starting in the year 2020 until end of 2021 and will be reported in the subsequent National Report.

Malaysia has started the process of getting the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety to be signed since early 2011. The Malaysian Biosafety Act does not have a specific provision on liability and redress. Therefore legal expertise as well as technical expertise is sought in this matter. An awareness workshop on Liability and Redress was conducted on the 30 September 2019 to provide an explanation on the topic. In addition, this has been added as a component in the new GEF capacity building project, whereby activities were proposed during the Inception Workshop that was held on 3-4 April 2019. The activities are scheduled to be conducted starting Q4 2019 until end of 2022 and will be reported in the subsequent National Report.

In Malaysia, enforcement officers from the Royal Malaysian Customs Department (RMC) are not involved in identification of LMOs. RMC is only involved in importation and exportation of goods products for tax collection. The sampling and monitoring of LMOs is done by the Malaysian Quarantine and Inspection Services (MAQIS) Department and Department of Agriculture, Sabah and Sarawak. Officers involved in taking samples of LMOs have been provided training.

The feature of the online version that provides direct reference to the previous National Report answers is very useful for comparison as baseline information and draft an up to date appropriate response for the 4th National Report. The online version was easy to use, there was no encounter of any bugs in the system and both versions (multiple choice questions and questions that required incorporation of text) of questions were problem-free. The system that enabled to work on and keep the draft was useful as well. The Reference table (indicating the changes made to questions in the 4th report in relation to the 3rd report) and the FAQs provided by the Secretariat proved to be useful supplementary resources to be used in preparation of the 4th National Report.