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Third National Report on the Implementation of the Cartagena Protocol on Biosafety
(NR3 )
last updated: 30 Oct 2015
General Information
Contact person submitting the report
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
10. Time period covered by this report
Party to the Cartagena Protocol on Biosafety
11. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
16. Which specific instruments are in place for the implementation of your national biosafety framework?
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?
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
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?
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
21. Here you may provide further details on the implementation of Article 2 in your country
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
23. If you answered Yes to question 22, has this information been submitted to the BCH?
24. Here you may provide further details on the implementation of Article 5 in your country:
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
26. Does your country regulate the contained use of LMOs?
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
28. Here you may provide further details on the implementation of Article 6 in your country:
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?
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
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?
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?
33. Has your country established legal requirements for the accuracy of information contained in the notification?
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
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?
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?
40. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
44. What percentage of your country’s decisions fall into the following categories?
45. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
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
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?
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
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?
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
53. How many LMOs-FFP has your country approved to date?
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
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?
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
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?
60. Has your country ever received a request for a review of a decision?
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
63. Has your country informed both the notifier and the BCH of the review and/or changes in the decision?
64. Has your country informed both the notifier and the BCH of the review and changes in the decision within thirty days?
65. Has your country provided reasons to both the notifier and the BCH for the review and/or changes in the decision?
66. Here you may provide further details on the implementation of Article 12 in your country
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?
68. Has your country ever applied the simplified procedure?
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?
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
71. Here you may provide further details on the implementation of Article 13 in your country
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
73. If you answered Yes to question 72, how many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
74. If you answered Yes to question 72, has your country informed the Parties through the BCH of the agreements or arrangements?
75. If you answered Yes to question 72, please provide a brief description of the scope and objective of the agreements or arrangements entered into
76. Here you may provide further details on the implementation of Article 14 in your country
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?
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
79 a. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Risk assessment:
79 b. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Management / Control:
79 c. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
Monitoring:
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
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?
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
84 a. 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?
Detect:
84 b. 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?
Identify:
84 c. 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?
Assess:
84 d. 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?
Monitor:
85 a. 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?
Risk assessment:
85 b. 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?
Risk management:
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?
87. Has your country adopted any common approaches to risk assessment with other countries?
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?
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?
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
LMOs for Contained use
LMOs for direct use as food
LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
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?
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
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?
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
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?
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
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?
102. If you answered Yes to question 101, has your country notified affected or potentially affected States, the BCH and, where appropriate, relevant international organizations, of the above release?
103. If you answered Yes to question 101, who did your country notify?
104. If you answered Yes to question 101, has your country immediately consulted the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures?
105. Here you may provide further details on the implementation of Article 17 in your country
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?
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?
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?
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?
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?
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?
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?
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?
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
116. How many customs officers in your country have received training in the identification of LMOs?
117. Has your country established procedures for the sampling and detection of LMOs?
118. How many laboratory personnel in your country have received training in detection of LMOs?
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
120. How many laboratories in your country are certified for LMO detection?
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
122. Here you may provide further details on the implementation of Article 18 in your country:
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?
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?
125. Here you may provide further details on the implementation of Article 19 in your country
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126 a. 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.
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))
126 b. 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.
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)
126 c. 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.
Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
126 d. 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.
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))
126 e. 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.
Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
126 f. 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.
Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
126 g. 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.
Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
126 h. 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.
Illegal transboundary movements of LMOs (Article 25, paragraph 3)
126 i. 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.
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))
126 j. 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.
Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
126 k. 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.
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)
126 l. 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.
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))
126 m. 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.
Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
