Malaysian Biosafety Act entered into force on 1 December 2009. The Biosafety (Approval and Notification) Regulations 2010 was enforced on 1 November 2010. This Act complements the National Policy on Biological Diversity (1998) and the National Biotechnology Policy (2005) 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 Natural Resources and Environment 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.

The Malaysian Biosafety (Approval and Notification) Regulations 2010 makes clear that there is no need to seek approval or notify in respect of 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 – <br />1) It must be a pharmaceutical product of LMOs; and<br />2) It must be:<br />&nbsp; &nbsp;&nbsp; i. addressed by relevant international treaties; or<br />&nbsp; &nbsp;&nbsp; ii. addressed by relevant international organisations, or <br />&nbsp; &nbsp;&nbsp; iii. regulated under any other written laws relating to pharmaceuticals.<br />However, the production of human and animal pharmaceutical products of LMO are regulated by the Malaysian Biosafety Act 2007. The trial phase of locally developed animal pharmaceutical products of LMO is regulated by the Department of Veterinary Services.<br />

Contained use activities involving LMOs are regulated under the Malaysian Biosafety Act 2007. “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 of the various containment levels is provided in the Biosafety Guidelines for Contained Use Activity of Living Modified Organism.<br />Transit of LMOs is not regulated under the Malaysian Biosafety Act 2007.<br />

Export and import of LMOs are regulated under the Malaysian Biosafety Act. Anyone who wants to export LMOs must first notify the NBB to do so. He must comply with the requirements of the importing country and must inform the NBB of such requirement and provide evidence that he has complied with these requirements. The export can commence once the acknowledgement of receipt of notification is issued by the Department of Biosafety. 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 a LMO or product of a LMO, 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 Act have been uploaded to the BCH.<br />The Department of Chemistry, Malaysia has the expertise and accreditation for detection of LMOs. However, more facilities need to be established, equipped and accredited so that the country will have adequate capacity to detect and identify LMOs. Detection of stacked events remains a problem as there is currently no protocol to detect stacked events.<br />

Under the national biosafety law, “release activity” means any intentional introduction of LMOs or products of such organisms into the environment through the activities or for the following purposes – <br />i) Research and Development purposes in all field experiments;<br />ii) Supply or offer to supply for sale or placing on the market;<br />iii) Offer as gift, prize or free item;<br />iv) Disposal;<br />v) Remediation purposes; and <br />vi) Any other activity which does not amount to contained use<br />In this context, domestic use, including placing on the market of LMOs-FFP is subject to the law. However, the Minister of Natural Resources and Environment has granted exemption for any subsequent release activity for the purposes of supply or offer to supply for sale or placing on the market, and offer as gift, prize or free item, where the LMOs and products of such organisms have been approved for direct use as food or feed, or processing (FFP). As of 31 July 2015, Malaysia has approved 14 LMOs-FFP.<br />

The NBB may, in consultation with GMAC, 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.&nbsp; If the NBB is convinced that there is a risk posed to human, plant or animal health, the environment or biological diversity, the NBB 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; (vi) make any other order as the NBB thinks fit in the interest of biosafety. On the other hand, any applicant or approved person aggrieved by a decision of the NBB 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 GMAC with reference to the risk assessment relating to the decision. If GMAC is convinced that the "new risk" has not been addressed, then the request will be further processed for a review of decision by the NBB.

The Minister has a power to make a direct exemption under the Malaysian Biosafety Act 2007. These exemptions include: i) any LMO event that has been approved for FFP, may be used for subsequent processing without seeking an approval again; 2) an export of an LMO to the same country, with the same LMO 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 biosafety law before any decision is made for LMO related activities. The Genetic Modification Advisory Committee (GMAC) has been appointed under the biosafety law 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. 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 on different types of LMOs. The workshops mainly targeted researchers and academicians and to date more than 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.

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. Currently, there are 3 agencies with laboratory facility for the detection of LMOs and the Department of Biosafety has access to these facilities. But only one laboratory i.e. facility at the Department of Chemistry has the sound expertise and accreditation for detection of LMOs which is recognized under the law. More facilities need to be established, equipped and accredited to ensure adequate capacity to detect and identify LMOs in Malaysia. In the last 4 years, 8 training workshops on LMO identification and detection had been conducted with the objective to raise awareness to customs and enforcement officers (who are based at the entry points on the requirements of the Protocol) 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 Natural Resources and Environment (NRE) 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 NRE acts 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 the NRE and its members comprise of representatives from Ministry of Agriculture and Agro-based Industry, Ministry of Health, Ministry of Plantation Industry and Commodities, Ministry of Domestic Trade, Co-operatives and Consumerism, Ministry of International Trade and Industry, Ministry of Science, Technology and Innovation, 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).

Malaysia has always strived to provide the stakeholders and public with a reliable reference point to get updated information on activities and current issues on biosafety to build confidence, ensure transparency and open communication besides ensuring a smooth transition towards implementation of the national biosafety law. In accordance with Article 20, Malaysia has provided all necessary information in the national Biosafety Clearing House. The website address is <a href="http://www.biosafety.nre.gov.my">http://www.biosafety.nre.gov.my</a> and it is under the management of the Department of Biosafety. The Department of Biosafety also created its own Facebook page (Department of Biosafety Malaysia) and activated a Twitter account to disseminate information on its activities. Malaysia feels information sharing is vital 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.

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 2007. 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 law. 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 to facilitate the smooth management and supervision of LMOs in this country. Malaysia realizes the importance of incorporating biosafety modules not only in tertiary and secondary school curriculum but also university curricula. We are now focusing our effort towards this and a comprehensive programme of work is necessary to address this need in a concerted manner. With the Secretary General of the Ministry of Natural Resources and Environment being the&nbsp; Chairman of the National Biosafety Board, biosafety obtained some allocations under GEF funds (for focal area biodiversity) for a biosafety capacity building project.

Department of Biosafety Malaysia

Malaysia with the support of the UNDP-GEF biosafety project has organized a few training courses for relevant officers on biosafety issues including to identify information that can be disclosed without breach of confidential business information, seminar/workshop on explaining science to the public and to increase awareness on biosafety issues and Malaysia’s international obligations. The Department of Biosafety also published education kits, flyers, newsletter, posters and booklet in different languages for different target groups on issues of biosafety. Besides that, we have translated the Cartagena Protocol on Biosafety text and annexes into the national language. Under this project, we also conducted a survey in 2011 to gauge public awareness on biosafety. Results from the survey have become a baseline to formulate future awareness programmes in Malaysia. Some of these activities are continuously implemented until today even though the project has completed in 2012. On public participation, it is a requirement under the law 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. Despite all activities done so far, many are still in the dark about biosafety and the Biosafety Act itself, the status of biosafety around the region as well as its impact to research and the industry. Thus, we see the need to disseminate accurate and balanced information about the Act and biosafety in general to all stakeholders and public in general.

During the period of reporting, Malaysia has approved the import of LMO for direct use as food or feed, or processing (FFP) from a non-Party.

The national legislation 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:<br />• Individual – Fine not exceeding RM250,000 and/or imprisonment not exceeding 5 years;<br />• Body corporate – Fine not exceeding RM500,000;<br />• If the offence is a continuing offence – further fine not exceeding:<br />o RM 10,000 for individual; <br />o RM 20,000 for body corporate;<br />for each day the offence continues after conviction<br /><br />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.<br />

Under the national legislation, the National Biosafety Board can take into account socio-economic considerations of the impact of the LMO. For example, the introduction of the LMO may have an effect on the existing social and economic patterns and means of livelihood of the communities. It may impact the religion, social, cultural and ethical values of communities.

The Department of Biosafety Malaysia for the first time organized a national workshop on socioeconomic considerations in the use of living modified organisms (LMOs) on 25th November 2014 in Kuala Lumpur. For this workshop, three (3) experts i.e. Prof. Gurdial Singh Nijar (CEBLAW, University of Malaya), Ms. Lim Li Ching (TWN) and Dr. Leonardo A. Gonzales (SIKAP/STRIVE Inc.) were invited to share their experiences on selected topics.&nbsp; Participants were also able to discuss on the elements of framework for conceptual clarity on socio-economic considerations during the afternoon session of the workshop.

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. A few consultations including a workshop was organized for this purpose. Since our biosafety law does not have a specific provision on liability and redress, we need to carry out a detailed assessment of the biosafety law in Malaysia and identify gaps in relation to provision on liability and redress. Results from this activity will help us in determining the most practical approach in formulating domestic biosafety law on liability and redress.

Like any other developing countries, Malaysia also faces major constraints and challenges in implementing activities related to biosafety. Some of the limitations and challenges are highlighted as follows:<br />(a) Limited funding and logistical resources for public awareness;<br />(b) Insufficient human resources (including professional or experienced communicators and educators in biosafety);<br />(c) Limited technological capacity;<br />(d) Limited availability of, or access to, awareness and educational materials on biosafety;<br />(e) The diversity of languages, high cost for translating available biosafety information into local languages in order to effectively inform and fully involve the public;<br />(f) Some Government senior officials and decision makers are unfamiliar with biosafety issues and unaware of the legal obligations of the Protocol;<br />(g) The highly scientific and technical nature of biosafety issues are not easy to explain to the general public; and<br />(h) The polarized debate in some countries on biotechnology and biosafety issues has made the promotion of public awareness, education and participation difficult<br /><br />

The overall experience of filling up this report has been good. <br /><br />However some points for consideration as follows:&nbsp; &nbsp; <br />1. The cross reference numbers to the Second National Report is not accurate (in the Word version), such as in Q94 of the Third National Report, the cross reference should actually refer to Q96 instead of Q88.<br />2. The online version of the form in Q126 does not have the option "Not applicable", but instead only the option "Information not available". We think that the option of "Information not available" could also imply that the Party is not aware or does not have the information. In some cases, for example 126(f), Malaysia does not regulate transit, therefore there is zero information on decisions with regards to transit. Therefore the accurate answer for us would be "Not applicable". However this option is available only for the Word version of the report and not available for the online version.<br />3. Some questions should have the option "Yes to an extent". This is because our country is perhaps at the beginning stages of implementing a requirement. For example, ability to identify an LMO. Our certified lab has the expertise to identify known events or for events that they have the certified reference material. But for an unknown event, this is a problem. To answer "Yes", implies that we are completely capable of identification. To answer "No" implies that we are not able to do it. An accurate reflection of our status is "Yes to an extent".&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />