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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102392
Status
Published
Date of creation
2011-09-30 09:05 UTC (johnny@nre.gov.my)
Date of last update
2011-10-12 09:46 UTC (johnny@nre.gov.my)
Date of publication
2011-10-12 09:46 UTC (johnny@nre.gov.my)

Origin of report
Country
  • Malaysia
Contact officer for report
Coordinates
Mr Letchumanan Ramatha
Director General
Department of Biosafety, Ministry of Natural Resources and Environment (NRE)
Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Presint 4, Federal Government Administrative Centre
Putrajaya, W.P. Putrajaya
Malaysia, 62574
Phone:+603-88861759
Fax:+603-88904935
Email:letchu@NRE.GOV.MY
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
National Biosafety Board, Genetic Modification Advisory Committee, Royal Customs And Excise Department Malaysia, Department of Malaysian Quarantine and Inspection Services, Economic Planning Unit, Sarawak State Planning Unit, Sabah State Planning Economic Unit, Other Relevant Government Ministries and Departments, Research Institutions, Universities, Federation of Malaysian Manufacturers, Federation of Malaysian Consumers Associations and Third World Network.
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-10-01
Time period covered by this report
End date
2011-09-30
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 fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • 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?
  • Yes
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?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
Malaysian Biosafety Act was passed in 2007 and entered into force on 1 December 2009. The Biosafety (Approval and Notification) Regulations 2010 were established and became effective on 1 November 2010. This Act furthers the National Biodiversity Policy (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 use in Malaysia. To provide scientific, technical and other relevant advice to the NBB, a committee by the name of the Genetic Modification Advisory Committee (GMAC) was established in May 2010. A dedicated Department of Biosafety carries out such duties as envisaged by the NBB and acts as one-stop centre for all activities relating to biosafety in Malaysia.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
Human and animal pharmaceuticals are regulated by National Pharmaceuticals Control Bureau under the Ministry of Health, Malaysia. The 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 2 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
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?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
Under the national biosafety law, transit of LMOs is not regulated. However the Strategic Trade Act 2010 which is under the purview of Ministry of International Trade and Industry, Malaysia regulates transit of items from any country into Malaysia by land, sea or air.
Contained use activities involving LMOs are regulated under the Malaysian Biosafety Act 2007. "Contained use" means any operation including R&D, 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 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, to determine the BSL required for the LMO, the risk assessment should be done. Guidance on requirements of the various containment levels is provided in the Biosafety Guidelines for Contained Use Activity of Living Modified Organism.
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?
  • Yes
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?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
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?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
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:
Export and import of LMOs are regulated under the Malaysian Biosafety Act. Anyone wishing to export a LMO 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. 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 purpose of the use of LMO to be imported. Decisions on approval for import have been conveyed to the notifier. All decisions made after the enforcement of the Act have been uploaded to the BCH.
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.
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?
  • Yes
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?
  • Yes
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?
  • Less than 5
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?
  • Less than 5
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • In some cases only
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:
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 -
i. R&D 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
Therefore, domestic use including placing on the market, of LMOs-FFP is subjected to the law. However, the Minister of Natural Resources and Environment has exempted 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). Since all decisions on FFP were made prior to enforcement of the Biosafety Act, it was not submitted to the BCH within 15 days.
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?
  • Yes
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:
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.  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.
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?
  • Yes
73. Has your country ever applied the simplified procedure?
  • Yes
74. If you answered Yes to question 73, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
  • Yes, always
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • Less than 5
76. Here you may provide further details on the implementation of Article 13 in your country:
There is no application procedure. It is a direct exemption by a Ministerial order made under the Malaysian Biosafety Act 2007. Any LMO event that has been approved for FFP, may be used for subsequent processing without seeking an approval again. 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.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. Here you may provide further details on the implementation of Article 14 in your country:
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. However, as a member of ASEAN treaty, Malaysia together with 9 other countries has been preparing the draft ASEAN Guidelines for Handling GMOs Transboundary Movement.
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?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • No
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • No
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
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?
  • In some cases only
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?
  • Less than 5
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?
  • No
93. Here you may provide further details on the implementation of Article 15 in your country:
GMAC has been appointed under the biosafety law to conduct a risk assessment and advise the NBB. Even though there is domestic capacity, but it is at its infancy, limited in number of experts and it has yet to be fully tested. This is also due to lack of experience as there is only a limited number of cases handled during the reporting period. At the moment, GMAC is referring to the guidance materials for risk assessment provided under the Protocol in their risk assessment work. The guidance was produced by the Ad hoc Technical Expert Group (AHTEG) of which there were 2 experts appointed from Malaysia. In addition, references are also made to other risk assessment guidance documents and reports made available by other regulatory agencies as well as other international bodies. The Department of Biosafety is engaging local experts in developing few guidelines on risk assessment for example Environmental Risk Assessment Guideline on GM Plant and Risk Assessment Manual on GM Microorganism.
Besides that, during the reporting period several risk assessment 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. The first phase of capacity building has been done, and there is increased awareness about risk assessment. However, expertise has been built for only a limited group of people and there is a pressing need to widen the building of expertise to more people for the implementation of biosafety regulatory activities. The Department of Biosafety will continue to sustain the development of national capacities in biosafety required to carry out risk assessment with appropriate scientific and technical skills. There must also be constant evaluation and strengthening of the legal and regulatory frameworks and development of infrastructure for information exchange and data management. More resources are needed so that a sustained mechanism can be established for this.
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?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
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?
  • Yes
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?
  • Yes
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:
Upon completion of risk assessment for any activity, additional risk management strategies are incorporated as conditions to the notifier, if necessary. A post release monitoring period may also be imposed for the purpose of ensuring that any unintentional adverse effects are addressed, if any.  Malaysia is part of the ASEAN GMO Testing Network which was established under ASEAN. This network is working towards building regional capacity in GM Food Testing mechanisms. 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. Setting up a dedicated portal and maintaining databases and accurate information about biosafety will also ensure greater public awareness and their wider participation in the country's utilization of LMOs for public health, wealth and economic growth.
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
107. Here you may provide further details on the implementation of Article 17 in your country:
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 living modified organism that had, or could have had, significant adverse effects on the conservation and sustainable use of biological diversity and/ or human health. There is an emergency response plan mechanisms in place to address non-GM invasive alien species by Department of Agriculture Malaysia that may be used and adopted accordingly for addressing emergency measures in case of unintentional transboundary movements of LMOs.
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?
  • Yes, to some extent
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?
  • Yes, to some extent
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
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?
  • Yes, to some extent
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?
  • Yes, to some extent
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:
Under the national legislation, the transportation involving LMO must be carried out in compliance with national and international regulations and guidelines. The LMO being transferred should be packaged in secure containers capable of preventing material loss during transportation. The LMO should also be kept separate from other materials. Additionally, the regulatory authorities, which are the IBC and the NBB, must be notified through the application form. Detailed explanation on the procedures for packaging and transport of LMOs are tabulated according to the type of LMO in the Biosafety Guidelines for the Contained Use Activity of LMOs. Malaysia also has made initial efforts to design documentation to fulfill requirements under Article 18. However without much experience in the public domain, we realized that we would need a longer time frame. Towards this, we have organized "Workshop on the Identification and Documentation of Living Modified Organism" in collaboration with the Secretariat of Convention on Biological Diversity (SCBD) in January 2010.  The objective of the workshop is to introduce to customs and enforcement officers, who are based at the entry points on the requirements of the Protocol, regarding the identification and documentation of LMO, and also the techniques/ methodologies that may be used for the implementation of these requirements.  A total of 50 participants from the Malaysian Quarantine and Inspection Services, Ministry of Health, Customs Department and Department of Agriculture attended the workshop. The legal mechanism to enable this is already in place, but in practice more interagency coordination, capacity building and awareness activities must be done before this can be fully implemented.
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, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
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:
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).
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 and 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 available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
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 available but only partially available in the BCH
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 only partially available 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 available and in the BCH
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 available but not in the BCH
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 available but only partially available in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
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, in some cases
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?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
In accordance with Article 20, the following information has been provided on the national Biosafety Clearing House -

 contact details for the competent authority;
 information about the vision, mission, objective and functions of the competent authority and its organisation chart;
 information about the functions of NBB and its chairperson and members;
 information about the functions of GMAC and its chairperson and members;
 Malaysian biosafety laws: the Biosafety Act 2007 and the Biosafety (Approval and Notification) Regulations 2010;
 the Guidelines for IBCs;
 the Biosafety Guidelines for Contained Use Activity of LMO;
 forms to be used;
 briefing on the approval process with a flow chart and downloadable approval application forms;
 briefing on the notification process with a flow chart and downloadable forms for notification; and
 the approved events, products and field experiments involving LMOs

The website address is http://www.biosafety.nre.gov.my and it is under the management of the Department of Biosafety.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
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 the Malaysian Biosafety Act 2007. This provision is consistent with the provision of the World Trade Organization.
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?
  • No
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?
  • Implementation of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase II)
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
  • Identification of LMOs, including their detection
  • Taking into account risks to human health
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • Yes
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
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
  • i) Impact of LMOs to non target organisms; ii) Risks to environment
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:
Malaysia has been carrying out capacity building activities in biosafety since 1997. However these activities are spread thinly across various institutes and universities.  The Biosafety Act 2007 has been enforced since 1 December 2009 and subsequently the National Biosafety Board (NBB), Genetic Modification Advisory Committee (GMAC) and Department of Biosafety had been formed in 2010 to pave way for the full implementation of the Protocol through the Biosafety Act. It has been well recognised that successful implementation of the Protocol is contingent on the development of continuous biosafety capacity building activities in 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. The NRE-UNDP-GEF Biosafety Project took stock of those past activities and moved ahead with the planning of set of activities/workshops that is cohesive in nature, emphasizing the importance of continuity of both the human resource factor as well as the sustainability of various stakeholders. The Department of Biosafety with support from the UNDP-GEF Biosafety project continued to conduct training workshops on various topics.  In addition, the project also assists the Department of Chemistry to equip their laboratory with specialized equipment for GMO detection. We were also fortunate to be invited and able to send officers of the Department to attend workshop focused on risk assessment, risk management, monitoring and enforcement of GMOs and related products. In regard to the general indication of the capacity-building needs, there is a need in risk assessment and risk management, technical and institutional collaboration. The other broad areas are socio-economic considerations; identification of LMOs, including their detection; scientific biosafety research relating to LMOs, institutional capacity-building, public awareness, participation and education, information exchange and data management including participation in the BCH. Pertaining to the Roster of Experts, Malaysia realised that there are local experts which are currently being nominated as members of the Genetic Modification Advisory Committee (GMAC) could also be nominated to the roster. In this context, Malaysia views closely the new criteria and minimum requirements for different categories of experts to be nominated to the roster.
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?
  • Yes, to a limited extent
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • No
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?
  • Less than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
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. This is clearly seen through the queries and presumptions from various stakeholders that have been expressed through formal letters, verbal communications in meetings and events. The ministry sees the need to disseminate accurate information about the Act and biosafety in general to all stakeholders and public in general. 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 stakeholders and public should be provided 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. Currently, the Department of Biosafety with the support of the UNDP-GEF project continues to organize training courses for officers of the department on biosafety issues and identifying info to be included in website without breach of confidential business information (CBI), workshop on explaining science to the public, to increase awareness on biosafety issues and Malaysia's international obligations.  The Department also published education kits, flyers, newsletter, posters and booklet in different languages for different target groups on issues of biosafety. Besides that, we have published the IBC and Containment Guidelines and translating the Cartagena Protocol on Biosafety (CPB) text and annexes into the national language. In this context, we work closely with few organizations including relevant government agencies. We also realized the importance of incorporating biosafety modules in tertiary and secondary school curriculum. A comprehensive programme of work is necessary to address this need in a concerted manner.
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?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • 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:
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. However, since the decision was made prior to enforcement of the Biosafety Act, it was not submitted to the BCH.
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?
  • Yes
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 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:
• 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 unintentional/illegal transboundary movement of LMO, which has been brought to the notice of the Government.
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?
  • Yes
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:
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.
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?
  • No
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:
Malaysia is still in process of getting the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety to be signed. The time between signing the supplementary protocol and ratifying it will be used to have a thorough consultation with relevant stakeholders. Malaysia believes the supplementary protocol would be beneficial to the country as it provides certainty in the event of damage. However, our concern is on preparing or building capacity of the biotechnology companies so that they will be involved when the domestic law is drafted.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
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.
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:
(a) Limited funding and logistical resources for public awareness;
(b) Insufficient human resources (including professional or experienced communicators and educators in biosafety);
(c) Limited technological capacity;
(d) Limited availability of, or access to, awareness and educational materials on biosafety;
(e) The diversity of languages, high cost translating available biosafety information into local languages in order to effectively inform and fully involve the public;
(f) Some Government senior officials and decision makers are unfamiliar with biosafety issues and unaware of the legal obligations of the Protocol;
(g) The highly scientific and technical nature of biosafety issues are not easy to explain to the general public; and

The polarized debate in some countries on biotechnology and biosafety issues has made the promotion of public awareness, education and participation difficult.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
Overall, there is no major difficulty in filling in the report. However option "Yes, to some extent" for some questions in the report should have an explanation to what extent can be used.
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
  • 2009
Here you may provide further details
The implementation of Malaysian Biosafety Act involves various Government agencies and their services are needed on case by case basis which sometimes can cost additional expenses for them. Apart from that, additional funding also allocated to purchase some equipment for the purpose of enforcement activities.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 5 per year or more
Here you may provide further details
Most of the biosafety related trainings are designed to meet specific needs of institution for example Biosafety Training Workshop and Biosafety Clearing House Workshop. Some other training for example Institutional Biosafety Committee Workshop and LMO Detection Workshop are opened to certain target group.
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
The Department of Biosafety is currently responsible in coordinating any biosafety capacity building activities. It works with other agencies or institutions for example the Department of Chemistry, Ministry of Health, Department of Agriculture, local universities and research institutions in formulating any activities depending on area of capacity.
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
  • 50,000 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
Funding for biosafety capacity building activities already being included as part of the Department of Biosafety annual operational budget. However, amount allocated for this activity is very minimal and limited.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
Here you may provide further details
Malaysia has not entered into any bilateral, regional or multi-lateral agreements or arrangements with other Party/non-Parties.
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
  • Yes
Here you may provide further details
Malaysia usually refers to: (i) CODEX Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants; and (ii) Roadmap for Risk Assessment of Living Modified Organisms, (according to Annex III of the Cartagena Protocol on Biosafety produced by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management of the Convention on Biological Diversity) for assessments of events for the purpose of Food, Feed and Processing. In addition, relevant Biology Documents produced by OECD and OGTR are referred to as well.
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
  • Yes
Here you may provide further details
Details similar as Question 9.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Here you may provide further details
So far risk assessment has been done based on an individual basis. However, the mechanism of risk assessment developed by of the Gene Technology Regulator, Australia (OGTR, 2009) has been used in the assessment. In addition, decision documents and risk assessments done by other countries are referred to in the process of assessment.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
As of June 2013, the National Biosafety Board has approved 14 applications for release of LMO and 24 notifications for contained use activities. These decisions were made base of risk assessment conducted by Genetic Modification Advisory Committee.
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
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
Genetic Modification Advisory Committee (GMAC) has been appointed under the biosafety law to conduct a risk assessment and advise the National Biosafety Board (NBB). NBB or GMAC can form committee/sub-committee that will be looking into certain aspects to assist NBB or GMAC making their decision/assessment. Even though there is domestic capacity, but it is at its infancy, limited in number of experts and it has yet to be fully tested. The Department of Biosafety will continue to sustain the development of national capacities in biosafety required particularly to carry out risk assessment with appropriate scientific and technical skills. There must also be constant evaluation and strengthening of the legal and regulatory frameworks and development of infrastructure for information exchange and data management.
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
  • Yes
Here you may provide further details
Under the national legislation, the transportation involving LMO must be carried out in compliance with national and international regulations and guidelines. For example in the Biosafety Guidelines for the Contained Use Activity of LMO, it provides details procedures for packaging and transport of LMO according to the type of LMO. However, More resources are needed so that a sustained mechanism can be established for this.
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
As specified under Section 25 of Biosafety (Approval and Notification) Regulations 2010: The National Biosafety Board or the Minister, in taking into account socio-economic considerations pursuant to section 35 of the Act, may consider - i) the changes in the existing social and economic patterns and means of livelihood of the communities that are likely to be affected by the introduction of the living modified organisms or products of such organisms; and ii)the effects of the religion, social, cultural and ethical values of communities arising from the use or release of the living modified organisms or products of such organisms.
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
  • 10 or more
Here you may provide further details
Fast expansion in modern biotechnology and numerous challenges that are emerging necessitates the development of a simple framework for socioeconomic analysis based on experiences in other areas. For this purpose, peer-reviewed published materials will always being used.
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
The following two cases are examples whereby the National Biosafety Board made their decision by also considering socio-economic aspects: i) Limited Mark-Release-Recapture (MRR) of Aedes aegypti wild type and OX513A(My1); and ii) TMOF_Yeast containing TMOF (Trypsin Modulating Oostatic Factor) peptide which is formulated into Mousticide Rice Husk (RH) and Mousticide Wettable Powder (WP). Details on these case studies can be obtained here: http://ris.org.in/images/RIS_images/pdf/ABDR%20November%202012.pdf
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
  • Yes
Here you may provide further details
At present, even though there is domestic capacity, but it is at its infancy, limited in number of officers and it has yet to be fully tested which is also due to lack of experience.
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
  • 50 or more
Survey 19.b) Monitoring
  • 50 or more
Survey 19.c) Management / Control
  • 50 or more
Here you may provide further details
The workshops mainly targeted regulators, researchers and academicians. The first phase of capacity building has been done, and there is increased awareness about risk assessment. However, expertise has been built for only a limited group of people and there is a pressing need to widen the building of expertise to more people for the implementation of biosafety regulatory activities.
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
It is a requirement under the Biosafety Regulations 2010 for any institution dealings with LMO to establish Institutional Biosafety Committee (IBC). Until June 2013, 26 institutions have registered their IBC and all of them have laboratory facilities.
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
The followings guidelines had been used for this purpose: i) Guidelines for Contained Use Activity of Living Modified Organism; ii) Guidelines for Institutional Biosafety Committee; iii) Guidelines for Risk Assessment of Genetically Modified Microorganisms; iv) Guidelines for Environmental Risk Assessment of Genetically Modified Plants in Malaysia; and v) Guidelines for Confined Field Trial of Living Modified Plants in Malaysia.
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
  • No
Here you may provide further details
To keep abreast with fast expansion in modern biotechnology, new guidelines are needed and existing guidelines may have to be amended from time to time.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
The objective of the training is to introduce to customs and enforcement officers, who are based at the entry points on the requirements of the Protocol, regarding the identification and documentation of LMO, and also the techniques/ methodologies that may be used for the implementation of these requirements.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
For the last 4 years, 8 training workshops on LMO detection had been 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
At present, 3 agencies have laboratory facility for the detection of LMOs which the Department of Biosafety have reliable access to these facilities.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
For the time being, only laboratory facility at the Department of Chemistry 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.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
The laboratory facility at the Department of Chemistry is currently operational.
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
Here you may provide further details
Malaysia has not received any financial assistance so far. However, the Department of Biosafety has participated in several international workshops which also discussed on liability and redress.
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
The existing biosafety framework does not have any provision on liability and redress.
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
  • Yes
Here you may provide further details
Public consultation is part of the process before the National Biosafety Board makes any decision on release of LMOs.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Newspaper
  • Forums
  • Mailing lists
  • Twitter and Facebook
Here you may provide further details
Public announcement is in the form of a standard notice published at minimum in 2 relevant newspapers (one Bahasa Malaysia and one English newspaper with nationwide coverage).
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
At present, biosafety only being taught as one of the topic under biotechnology subject. More efforts are needed to encourage more institutions offering biosafety education in their curricula.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • 5 or more
Here you may provide further details
All biosafety training materials are uploaded in the Malaysia Biosafety Clearing House website http://www.biosafety.nre.gov.my/
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Here you may provide further details
The Department of Biosafety is responsible in carrying out such duties as envisaged by the National Biosafety Board and acts as one-stop centre for all activities relating to biosafety in Malaysia.
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
  • 10 or more
Here you may provide further details
These events are categorized according to focus area e.g. risk assessment/ risk communication/risk management; GMO detection; Institutional Biosafety Committee (IBC); Identification and documentation of LMO; Biosafety Clearing House (BCH); and biosafety awareness campaign/seminar.
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
All biosafety related publications are uploaded in the Malaysia Biosafety Clearing House website http://www.biosafety.nre.gov.my/
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National website
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
  • One or more
Here you may provide further details
The Department of Biosafety has collaborated with the Malaysian Biotechnology Corporation and the Asia-Pacific Economic Cooperation in organizing biosafety related workshops.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
The modalities used for outreach programmes on biosafety include seminar, road show and exhibition.
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 Department of Biosafety is responsible in carrying out any programmes on biosafety at local and national level. However, due to lack of manpower, some of these programmes are jointly organized with other agencies and institutions particularly local programmes.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Here you may provide further details
Focus will be given into this aspect in the upcoming biosafety capacity building project under the Global Environment Facility fund.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 10 or more
Here you may provide further details
These materials are in the form biosafety newsletter, guidelines, educational video and handbook which is available in the Malaysia Biosafety Clearing House website http://www.biosafety.nre.gov.my/