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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102311
Status
Published
Date of creation
2011-09-15 12:37 UTC (lozan@mediu.gov.md/3811)
Date of last update
2011-10-27 19:30 UTC (andrew.bowers@cbd.int)
Date of publication
2011-10-27 19:30 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Republic of Moldova
Contact officer for report
Coordinates
Dr. Angela Lozan
Biosafety Office, Head
Ministry of Environment (ME)
[ Cosmonautilor Str. 9
Chisinau
Republic of Moldova, 2005
Phone:+373 22 22 68 74
Fax:+373 22 22 68 74
Email:angelalozan@yahoo.com
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
[               Ministry of Environment, Ministry of Agriculture and Food Industry, Ministry of Healthcare, Academy of Sciences of Moldova, State University of Moldova, State Agrarian University of Moldova, Research Institute of Phytotechnics, Eco-Tiras NGO, Ecospectrum NGO, REC-Moldova NGO, Customs Control Services, Ecological Inspectorate, General Agricultural Inspectorate, farmers and farmer associations.  youth, women etc. 
Submission
10. Date of submission
2011-09-15
11. Time period covered by this report
Start date
2007-09-15
Time period covered by this report
End date
2011-09-15
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 partially in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • No
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?
  • Less than 5
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:
The Ministry of Environment is appointed as Competent National Biosafety authority in 2003, by the Governmental Decision Nr.197 of 2003. The Section on Biodiversity and Biosafety within the Division of Natural Resources and Biodiversity has been established in 2009. National Biosafety Committee as an intergovernmental body responsible for examination of notifications, is established by Governmental Decision Nr.603 of 2003.  National laws, regulations and guidelines related to biosafety have been submitted to the Biosafety Clearing House.      
           
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
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?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
[  The National Biosafety Law (2001) covers all types of LMOs uses, including transboundary movement, contained use (Chapter III - Contained use of LMOs, Chapter VI - Import/export of LMOs). The National Law is posed to the BCH  and available to the public.
To be mentioned that there were no cases so far of LMOs transit or contained use in Moldova. There were no notification submitted to the National Biosafety Authority.Threrefore, no information on transit and contained use of LMOs has been posted via the BCH.  
                     
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?
  • No
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:
[     The National biosafety authorities have not received so far any notifications on intentions to introduce LMOs in Moldova, neither imported nor produced in the country. The mechanism and procedures for examination of notifications is described in detail in the National Biosafety Law for all cases of LMOs use, including the contained use, deliberate release in environment, placing to the market and import/export transboundary movement. A set os special regulations related to authorisation of activities with LMOs specify the accuracy and contents of information requested from notifyer during the submission and handling of notifications.                                                   Type your text here                                                       ]
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)?
  • No
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:
[The Law on Biosafety (Chapter V - Placing to the market of LMOs) stipulates the authorisation for use of all types of GMOs products including LMOs-FFP. Along with the general requirements for information to be submitted during notification process for LMOs-FFP, there are specific requirments regarding the packaging and labeling. Namely, the wording "products contain genetically modified organisms" is obligarory both on the lable and on the acmmpanying documents. The labeling is obligatory in cases when the contents of GMOs in the product is no less than 1%, and for seeds - 0,3% of the total product weight. 
Moldova has not been a Party of export of LMOs intended for FFP during the reporting period.                                                       ]
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?
  • No
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 Chapter IV of the Regulation on Authorisation of activities related to obtaining, testing, use and commercialization of GMOs (Governmental Decision Nr.1153 of 2003)stipulates the mechanism of authorisation  cancellation in the following cases: (a)if the data presented for authorisation receiving are not in compliance with the reality; (b) if notifyer does not respect the conditions stipulated in the domestic legislation and in authorisation; (b) in case of heavy accident produced, for which a holder of authorisation bears responsibility.
At the same time, there are no specific stipulations in Moldovan regulation that establish mechanism for review of authorisations and decisions.
                                                        
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?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
[ In the Law on Biosafety (Chapter V - Placing to the market of LMOs, Art.27) the simplified procedures are allowed in the cases when the product's placing to the market has been already authorised and is realised in the EU member states, and consumption of the mentioned products resulted from GMOs is approved for EU member states.                                                     
During the reporting period, Moldova has not applied the simplified procedure as there was no any application for permission for LMO use/transboundary movement.
The simplified procedure is stipulated in the Law on Biosafety and Regulations regarding the issuance of permissions for various types of activities related to the experimentation, manufacture, utilization and creation of genetically modified organisms.
The National Biosafety Commission can, if required, implement the rules and criteria of more simplified procedures for the confirmation of the types of activities related to the intentional introduction of genetically modified organisms into the environment on condition that:
- the taxonomy and the biology of the genetically modified organism is reasonably well known;
- information on the risk assessment of the impact on plants and other organisms involved in the ecosystem being tested is available;
- there are scientific data of the results of the experimental introduction of genetically modified organisms into the environment that relate to the same type of receptor plant;
- the elements that are introduced and their various forms be fail-safe as regards the health of people and of the environment under experimental conditions.
-the inclusions must be described meticulously and integrated into the nuclear genome of the plant. 
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:
[  In the Action Plan "EU-Moldova" (2001) the requitements are mentioned  regarding the harmonization of Moldova's national legislation with the European Directives in the field of Biosafety .                                                      Type your text here                                                       ]
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?
  • No
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • No
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?
  • No
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
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?
  • No
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
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?
  • None
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:
[ The requirement of conducting the Risk Assessment is stipulated by the domestic Biosafety Law. Several specific regulations describe the procedures and general requiremennts for information related to the risk assessment analysis, and provide the guidelines for risk assessment procedures. However, there is a lack of specific mechanism for experts selection to conduct the risk assessment, as well as there are limited capacities for training of RA experts. By the moment, there is no any domestic experience in providing the risk assessment. Moldovan legislation stipulates that the costs of risk assessment conducting should be beared by notifyer.  
According to the Law, the risk assessment should be carried out in a scientifically sound and transparent manner. The goal of the assessment is to identify any adverse negative effects of the genetically modified organisms and/or the products derived therefrom on hunam health or environment.
The National Commission, according to Moldovan regulation, should appoint qualified public bodies or scientific institutions which will carry out the risk assessment.
The financial burden of the risk assessment is borne by the applicant, according to domestic regulation.
The CBD/CPB Secretariat and the Ministry of Environment organized the CEE Subregional workshop on Risk assessment and risk management, Chisinau, Moldova in 2008                                              ]
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, to some extent
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes, to some extent
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
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?
  • No
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?
  • No
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:
[ Control and monitoring of LMOs are the duties of the Ministry of Environment, Ministry of Healthcare and Ministry of Agriculture, National Biosafety Committee and specialized Inspectorates. It is required that during notification, the Monitoring and Management Plan and Emergency measures should be provided by notifyer.
At the same time, there is no practical experience in conducting the risk management of LMOs in Moldova so far.                                                      
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?
  • No
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?
  • Yes
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:
[ Biosafety Law (Chapter III - Contained use of LMOs, Art.13) stipulates the obligatory elaboration of Emergency Plan, including the relevant security actions and measures. Guidelines on Emergency measures were elaborated and improved to enforce the national competent authorities with the mechanism of consequences minimization in case of eventual accidents. The Regulation on authorisation the activities related to obtaining, testing, use and commercialization of LMOs (Governmental Decision Nr.1153 of 2003) requires the elaboration of Action Plan of Emergency measures in case of accidents, including the methods and procedures for control of LMOs, methods of decontamination of affected zones, methods of GMOs elimination, isolation of affected zones, plans of human health and environment protection.                                                       
During the reporting period, there were no cases 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.
According to the Law on Biosafety, in cases of illegal transportation of genetically modified organisms and/or the products derived therefrom, the authorized national authprity have the right to demand from the country of export their return or destruction at their expense in accordance with the standards of international law.
In case of the illegal transport of genetically modified organisms and/or of products derived therefrom, the relevant international bodies should be informed, according to the domestic regulation.
In the case of the unintentional transboundary movement of genetically modified organisms and/or the products derived therefrom, the relevant national bodies shall implement measures of notification provided for by international legislation, as well as measures to eliminate any and all risks to the human health and the environment.
The National Commission will inform the public on the measures taken to prevent the occurrence of a situation that may occur due to the unintentional transboundary movement of genetically modified organisms and/or the products derived therefrom. 
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, to some extent
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:
[ The procedures for handling, storage, packaging and labeling are stipulated in the legislation (Regulation on Authorisation of activities related to obtaining, testing, use and commercialization of LMOs, Governmental Decision Nr.1153 of 2003), specifically in case of placing to the market and FFP. Art.III of this Regulation stipulates the  norms of labeling of LMOs and, specifically, the detailed information to be reflected on label and also the rules for packaging.   There are Norms on labeling of foodstuffs and Norms for labeling of chemical household products (Governmental Decision nr.966 of 2003). Draft of the Guidelines on conditions of LMOs transportation is elaborated and submitted to approval.                                                           
According to Article 24 of the Law on Biosafety, the producer or the importer should present information to the National Commission which include the specific conditions of utilization and handling as well as recommendations related to the packaging, labeling and identification. The presence of genetically modified organisms must be clearly indicated on the label and /or on accompanying documentation. It is obligatory that the words "This product contains genetically modified organisms" appear on both the label and the accompanying documents. Information concerning the presence of genetically modified organisms must take up no less than ten percent of the surface of the label and/or the accompanying documents. Products that contain genetically modified organisms and/or the products derived thereform which total no less than one percent of the total weight are recognized as being genetically modified products. For seeds, the percentage is 0.3 percent of the total weight.
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 Environment has been apponted as the competent National Authority by the Governmental decision Nr.197 of 2003. National Focal Points on Cartagena Protocol and BCH are appointed and in duty to provide communication and connections with the CP Secretariat. The National databases and information are regularly submitted and available via central portal BCH. Domestic BCH website (http://www.biosafety.md) containes biosafety contact information, institutional setting-up and regulations on biosafety in place. The website also contains templates for eventual decisions for all types of LMOs use in accordance with the Cartagena Protocol, as well as template for National GMOs register.                                                         Type your text here                                                       ]
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 not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
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 not available
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 not available
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 not available
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 not available
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 not available
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, always
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:
[ The basic National information  on Biosafety is submitted via BCH, is complete and up-to-date. It contains contact details, domestic regulations in the field of biosafety, institutional setting-ups, publications. As soon as there were no any decisions taken so far on notifications, no appropriate information is placed on BCH, related to decisions on LMOs.                                                          
A National website on BCH http://www.biosafety.md  is elaborated and available for the government decision makers and public.
The following information is placed via the Biosafety Clearing-House.
1. Detailed contact information for authorized competent national authority and sectorial national bodies
2. National Focal points for CP, BCH and Emergency situation, as well as coordination centers and individuals to be contacted in the case of emergency
3. The national regulation in the field of Biosafety
4. Publications on national language in the field of biosafety
5. Capacity building (Biosafety projects)
6. Country needs and priorities
7. National Biosafety website http://www.biosafety.md
8. Roster of national experts in the field of Biosafety.

There were no obstacles or impediments related to the presentation of such information text here                                                       ]
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • No
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • No
134. Here you may provide further details on the implementation of Article 21 in your country:
[  Special Regulation on public information in the field of GMOs and public participation in decision-making (Nr.96, 2009) stipulates requirements to information which should be presented to broad public during the consultation process.  At the same time, information to be presented should not be considered as confidential.
Up to now there are no specific mechanisms  elaborated to protect the confidential information regarding LMOS.                                                    
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?
  • No
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.
  • Easy
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Implementation of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
  • 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
  • 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
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
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.
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • 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
148. Has your country developed a capacity-building strategy or action plan?
  • Yes
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:
[ Moldova has accessed the GEF funds and benefited from the GEF Technical assistance to develop biosafety capacities in the country, and specifically, Development NBF project, Implementation NBF project, BCH I and BCH II projects.
No any bilateral or multi-lateral activities in the field of biosafety were undertaken. Moldova has approved the National Biosafety Action Plan as political document for the period 2009-2015, which involves many different actors and aimed to strengthen capacity building in the field of biosafety.                                                        Type your text here                                                       ]The CBD/CPB 4th Capacity Building meeting for governments and organizations implementing or funding biosafety activities under the Cartagena Protocol on Biosafety, organised in Chisinau, Moldova, April, 2011 (with the support of the Ministry of Environment).

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?
  • Yes
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
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, to a limited extent
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
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?
  • Yes
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?
  • None
160. Here you may provide further details on the implementation of Article 23 in your country:
[   The mechanism for public information and public participation to decision-making process relating the LMOs is developed and in placce, and enforced by the special Guidelines Nr.96 of 2009. This document also contains the means of public information via internet, bulletins, mass-media, broadcasts, etc., the contents of the summary, list of interested public, public hearings and public consultations, requirements for confidential information, etc.
   The Biosafety law, Chapter VII - Public information and consuptation, Art.39, stipulates legislative requirements for public information and consultation, namely: within 10 days of reciving the notification, the National Biosafety Committee informs the public about this, specifying the ways of  public access to this information. Within 30 days the public cooemts should be received and taken in consideraion during the final decision.
BCH website (http://www.biosafety.md) contains information available to general public as well as the electronic Register of interested public, Register of decisions and Register of GMOs available during the decision-making. A feedback option on the BCH website is also in place.
  The trainings, workshops, seminars were organised, publications, guidelines, manuals and mass-media mediatisation were ensured.                                                      
Moldova hosted the 4th Conference of Parties of the Aarhus Convention on public information, access to justice and public participation to decision making, Chisinau, June 2011. A side event on GMOs issues was held during the COP4.
In accordance with the Law on Biosafety, a representative of non-governmental organizations is a part of the National Commission on Biosafety.
National BCH website provides public with relevant biosafety information http://www.biosafety.md. A National Register on interested public and NGO is elaborated and posted via BCH.
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?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • 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?
  • No
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?
  • No
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • No
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:
So far there were no illegal transboundary movements of LMOs in Moldova detected, and, accordingly, no management procedures applied for these cases.                                                     
In accordance with Article 40 of the Act on Biosafety, illegal activity in the reception, testing, manufacture, utilization, creation, import and export of genetically modified organisms and/or products derived therefrom is restricted by the law.
If, as a consequence of activities related to the reception, testing, manufacture, utilization, creation and importation of genetically modified organisms, and/or the products derived therefrom, there is exposure to risk or there is damage to public health and the environment, the user and/or the importer, as the case may be, bear responsibility under the law.
The degree of risk, and the nature and extent of damages, are determined by an expert commission appointed by the National Commission from representatives of central bodies responsible for the protection of the environment, agriculture, the food industry and the public health service.
Compensation for damages proposed by the expert commission is set through judicial channels.
If the damages resulting from the importation and utilization of genetically modified organisms, and/or the products derived therefrom, occur on the territory of this country, the provisions of international legislation, one Party of which is the Republic of Moldava, which regulates the transboundary movement of the identified organisms and products, come into effect.
Amendments to the Legal Code on administrative contravention (infringements) were suggested to implement these measures.our text here                                                       ]
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?
  • No
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
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?
  • Yes
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:
[  Moldova is going to signing of Nagoya-Kuala Lumpur Supplimentary Protocol on Liability and Redress and is expected to sign it at the UN CBD signing Ceremony in New York , September 2011.


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.
The Intermediate and First Moldova National  Biosafety Reports have been elaborated and submitted timely to the Secretariate of the CP and are available via BCH. During the previous Reporting period, there were certain limitations in organisation of consultation process, due to the limited available financing.                                                      
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 reporting format is very helpful, clear and consize and makes it possible in a logic manner to provide comprehensive information covering the main topics and issues reflected in the Cartagena Protocol on Biosafety.  The proposed format helps to organize and structure the national biosafety information. This Report is also useful for the national governmental authorities to monitor  the  biosafety status in the country, to provide coordination between the responsible institutions, academia and civil society. The Second Moldovan National Biosafety Report will be made available via BCH of  CBD Secretariat, as well as via National CBD: http://www.biosafety.md.
We express our gratitude to the CBD CPB Secretariat and the experts which were involved in elaboration of the format and questonnarie for the national reporting.                                                              ]
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
  • 2010
Here you may provide further details
Beyond the regular national bugetary allocation, Moldova supported the implementation of the Protocol by the following:  2007 - co-financing of the Regional CBD workshop on Risc assessment/management.  2009 - co-financing of the UNEPMeeting on Implementation projects,  2011 - co-financing of the CBD/CPB Capacity Building workshop under the Cartagena Protocol  2012-2013 - project allocations from the National Ecological Fund - Biosafety monitoring project
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
During 2011-2013 there are a number of trainings organized in the country. 5 days training on risk assessment - 2011,   three 3 days BCH trainings 2011-2012. A workshop on Biosafety is planned to be held in June 2013 (under the National Ecological Fund project)  For 2014 a regional training on Biosafety is expected to be hosted by Moldova.  The university academic courses involves the GMOs and modern biotechnology as well as biosafety and sustainable development. The courses are teaching for the undergraduate and master degree students of the State Moldovan University and the State Agrarian University.
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 Ministry of Environment is nominated as the National Biosafety Authority and also is in duty to coordinate the biosafety capacity building initiatives. The National Biosafety Commission is leaded by the Ministry of Environment and involves all relevant sectors of government, academia, universities and NGOs to participate at decision making. A BCH network and national BCH webpage http://www.biosafety.md also serves for communication and informed decision making.
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
  • 5,000 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
  • No
Here you may provide further details
Biosafety is funded by the budget allocations in a package with the general issues of environmental protection and the biodiversity issues. No specific allocations for capacity building offered in a regular mode.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
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
  • No
Survey 9.b) Risk management
  • No
Here you may provide further details
A guidance (secondary level regulation) on authorization of GMOs uses is approved in 2003 and contains specifications of  quality of information related adverse risks requested during the notification. There is no guidance document in place to advise the procedure of conducting risk assessment /management.
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
  • No
Here you may provide further details
A guidance (secondary level regulation) on authorization of GMOs uses is approved in 2003 and contains specifications of  quality of information related adverse risks of LMOs that is requested to be submitted by the notifiers during decision making. There is no guidance document in place to advise the evaluating risk assessment /management reports.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • No
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
  • No
Survey 13.b) Assess
  • No
Survey 13.c) Monitor
  • No
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
  • No
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
  • No
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
  • None
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
no country experience in taking socio-economic consideration on LMOs
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
  • No
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
  • 10 or more
Survey 19.c) Management / Control
  • None
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
The laboratory infrastructure is not complete and fully in place. The laboratories in the country are not accredited to the international standards for LMOs detection. There is needs to equipped with some laboratory equipment, kits and materials, as well as validation of methods and training of personnel.
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
Yes, training materials and technical guidance are used during the workshops and university courses. There is need to have the training materials in the national or regional language.
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
  • Yes
Here you may provide further details
We will request to have technical guidance and training materials for risk assessment of specific risks, traits, specific LMOs. For example the guidance on risk assessment of RNA, proteins, trees, insects, centers of origin of species etc.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
A number of 5-7 laboratory operators have been trained for laboratory detection methods as during the foreign stages in Russia, USA, as well as during the national short term training course. There is need to further training of the personnel for standard detection methods of GMOs.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • No
Here you may provide further details
Not enough laboratory facilities and infrastructure in country.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • None
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • None
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
  • Yes
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
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
Art. 39 of the National Law on Biosafety provides a mechanism for public information and participation to decision making on GMOs.  A special guidance is available to provide tools and instruments for public information and participation. The BCH website is also served for public information and participation, offered the feedback options. A series of workshops and trainings organized with invitation of public and NGOs. A Register of interested public and NGOs is available and in place.
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
  • Public hearings
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
State University of Moldova and the State Agrarian University developed curricula for Biosafety and related topics for undergraduate and master degree students within the molecular biology and agronomy specializations.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • None
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • No
Survey 35.b) Enforcement system
  • No
Here you may provide further details
The monitoring and enforcement systems in Moldova are partially developed and not fully in place. The administrative and penal codes have no special provisions for violation of the Biosafety law with regards to damage have occur from LMOs. The laboratory for detection of LMOs is not fully workable to provide support for monitoring and control of LMOs. Inspection and monitoring undertaken by the National ecological authorities are not in a regular base. The national website offers template for information sharing between main actors and stakeholders, but in practice are not efficient used.
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
  • 5 or more
Here you may provide further details
2011 - CBD/CP Capacity building workshop and the liason group  2011 - COP - 4 of the Aarhus convention. A side event on GMOs organized  2010-2012 - FAO workshops on  GMOs and biotechnology organized in Chisinau
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
  • 10 or more
Here you may provide further details
A total number of 13 books, brochures on various topics of Biosafety are published in the national language and available to people, stakeholders, decision makers etc.
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
Moldova undertaken joint initiative for the CP and the Aarhus convention  to ensure public information and access to decision making. A workshop on the joint topic organized in 2011.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
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.,
no programmes in place
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more
Here you may provide further details
Seven brochures on Biosafety available public information and participation in national language.