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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109107
Status
Published
Date of creation
2015-10-30 02:07 UTC (anita@nre.gov.my)
Date of last update
2017-02-17 04:16 UTC (anita@nre.gov.my)
Date of publication
2017-02-17 04:16 UTC (anita@nre.gov.my)

Origin of report
1. Country
  • Malaysia
Contact officer for report
Coordinates
Ms. Norsham Abdul Latip
Director General
Department of Biosafety Malaysia (DOB)
Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4
Putrajaya, Federal Government Administrative Centre
Malaysia, 62574
Phone:+60388861580
Fax:+60388904935
Email:norsham@nre.gov.my,biosafety@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, Relevant Government Ministries and Agencies, Research Institutions, Universities, Industry Associations and Non-Governmental Organizations
Submission
10. Date of submission
2015-10-30
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-09-30
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2009
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
  • Other laws, regulations or guidelines that indirectly apply to biosafety
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 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.
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?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
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 -
1) It must be a pharmaceutical product of LMOs; and
2) It must be:
     i. addressed by relevant international treaties; or
     ii. addressed by relevant international organisations, or
     iii. regulated under any other written laws relating to pharmaceuticals.
However, the production of human and animal pharmaceutical products of LMO are 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.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • No
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • 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:
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.
Transit of LMOs is not regulated under the Malaysian Biosafety Act 2007.
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • No
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • No
38. 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
39. 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
46. 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 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.
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)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. 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, always
58. 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) Research and Development purposes in all field experiments;
ii) Supply or offer to supply for sale or placing on the market;
iii) Offer as gift, prize or free item;
iv) Disposal;
v) Remediation purposes; and
vi) Any other activity which does not amount to contained use
In this context, domestic use, including placing on the market of LMOs-FFP is subject to the law. 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.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • Yes
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. 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. 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.
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
68. Has your country ever applied the simplified procedure?
  • Yes
69. If you answered Yes to question 68, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • More than 5
71. Here you may provide further details on the implementation of Article 13 in your country
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.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
76. 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.
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 100 or more
b) Management / Control:
  • 50 or more
c) Monitoring:
  • 50 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • No
84. Does your country have the capacity to detect, 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?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • No
c) Assess:
  • Yes
d) Monitor:
  • No
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • No
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. 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
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • No
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
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.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
Here you may provide further details
Integrated enforcement activities with relevant enforcement agencies at the entry points.
99. 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?
  • Yes, to some extent
Here you may provide further details
Referring and adopting existing mechanisms used by other enforcement agencies.
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. 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 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.
Article 18 – Handling, transport, packaging and identification
106. 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
Here you may provide further details
Some guidance is provided for movement, packaging and transportation of LMOs in the Guidelines.
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
Here you may provide further details
Malaysian Quarantine and Inspection Services Department has included in their form a requirement to declare an LMO item.
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
Here you may provide further details
Malaysian Quarantine and Inspection Services Department has included in their form a requirement to declare an LMO item.
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes, to some extent
Here you may provide further details
Malaysian Quarantine and Inspection Services Department has included in their form a requirement to declare an LMO item.
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
Here you may provide further details
Relevant officers from Malaysian Quarantine and Inspection Services Department were trained to enforce these requirements.
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 50 or more
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
Here you may provide further details
Department of Biosafety is currently in the process of drafting the sampling regulations.
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
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.
Article 19 – Competent National Authorities and National Focal Points
123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
124. 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
Here you may provide further details
Identification of overlapping regulatory scopes are being identified and enforcement coordination is being worked out.
125. 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)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
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 and in the BCH
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 and in the BCH
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
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information available and in the BCH
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
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 and in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. 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
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. 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:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • Distributed during workshops, seminars and exhibitions
135. Here you may provide further details on the implementation of Article 20 in your country
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 http://www.biosafety.nre.gov.my 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.
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. 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 under a specific provision under the Malaysian Biosafety Act 2007. This provision is consistent with the provision of the World Trade Organization.
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • Yes
140. 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, to some extent
Here you may provide further details
Resource persons from other Parties have come for training activities.
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Bilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Average
146. 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)
147. 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, to some extent
Here you may provide further details
Development budget of the Department has been allocated for capacity building activities.
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • 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
  • Socio-economic considerations
  • Handling of confidential information
  • Liability and Redress
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, 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
  • Impact of LMOs on non target organism
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • Yes
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • No
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
157. 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. 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  Chairman of the National Biosafety Board, biosafety obtained some allocations under GEF funds (for focal area biodiversity) for a biosafety capacity building project.
Article 23 – Public awareness and participation
158. 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
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • No
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
Department of Biosafety Malaysia
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. 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?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes, to some extent
Here you may provide further details
For any application for release activities, public participation is a mandatory process. Announcement to invite public to participate will be made in four local newspapers (in different languages).
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
  • Mailing lists
  • Social media e.g. Facebook Page and Twitter
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • One or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • 10 or more
173. 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
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • No
175. 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?
  • More than 5
176. Here you may provide further details on the implementation of Article 23 in your country
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.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • No
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • Yes, always
183. 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.
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes, to some extent
Here you may provide further details
There is initative to detect, however these efforts and not comprehensive and needs to be further strengthened.
186. 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?
If you replied Never to question 186 please go to question 191
  • Never
191. 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 illegal transboundary movement of LMO, which has been brought to the notice of the Government.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. 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
194. 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?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
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.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
Here you may provide further details
Invited a speaker from Philippines for a socioeconomic workshop held in November 2014.
197. Here you may provide further details on the implementation of Article 26 in your country
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.  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.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • Yes
200. 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?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • Yes
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • No
202. 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 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.
Article 28 – Financial Mechanism and Resources
203. 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?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 500,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due 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 for 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
(h) 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
The overall experience of filling up this report has been good.

However some points for consideration as follows:   
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.
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.
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".