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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102924
Status
Published
Date of creation
2011-12-20 21:15 UTC (andrew.bowers@cbd.int)
Date of publication
2011-12-20 21:15 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Democratic People's Republic of Korea
Contact officer for report
Coordinates
Chol Guk KIM
CBD National Primary Focal Point
National Coordinating Committee for the Environment, DPR of Korea (NCCE)
Sungri Street, Jungsong Dong, Central District PO Box 44
Pyongyang
Democratic People's Republic of Korea
Phone:+85 02 18111/ext.382 7222
Fax:+85 02 381 4699
Email:hyong.chol.ri@undp.org
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
NCCE, DPRK
Committee for the Bio-safety
State Commission of Science and Technology
Commission of Education
State Commission of Quality Administration
Ministry of Foreign Trade
State Committee for the Comparison Test of Crops Varieties
State Biosafety Management Centre, State Academy of Sciences
Institute of Agro-Biology, Academy of Agricultural Science
Institute of Hygiene, Academy of Medical Science
Department of Life Science, Kim Il Sung University
Submission
10. Date of submission
2011-12-12
11. Time period covered by this report
Start date
2008
Time period covered by this report
End date
2011
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
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • Less than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Partially
21. Here you may provide further details on the implementation of Article 2 in your country:
The DPRK has developed the draft National Biosafety Framework(NBF) of DPRK through the implementation of the UNEP/GEF project from April 2002 to April 2004.

The draft NBF includes the purposes for the establishment of  National Biosafety Framework in DPRK, the principles and priority items underlying NBF.

Based on this, the DPRK, during the current reporting period, has attached special interest to, and exerted great efforts on, the establishment of NBF. As a result, series of successes were made in establishing legal and administrative system in the  field of biosafety management.

- Legal system
The DPRK, for the purpose of biosafety management, adopted the Cabinet Decision No. 64 regarding the Biosafety Management Regulation on October 21, 2003, thus ensuring the provisional legal base for biosafety management.

Later on, this provisional Regulation was nullified following the adoption of the Law, but a certain number of experiences and knowledge have been gained in the course of its implementation.

The DPRK has identified the biosafety management as one of  its priority policy issues in January, 2001, and promoted the preparative work of establishing the comprehensive legal system in this field.

Reflecting such policy requirements, the Presidium of the Supreme People's Assembly adopted the DPRK Biosafety Law as Cabinet Decision No. 867 on December 22, 2004  thus ensuring that the national biosafety management is based on a legal foundations.

The adoption of this Law clearly proves that the DPRK government gives a priority to the issue of biosafety management and is putting tangible efforts to this work.

It is a comprehensive Law that stipulates in a holistic way the purpose, mission, scope, objects of application, main principles, institutional system and responsibilities of the biosafety management in DPR of Korea.

The Law, based upon the principles of prevention, stipulates basic reuquirements, principles and procedures to be followed in the comprehensive biosafety management such as the procedures of application and approval according to the Advance Informed Agreement(AIA), risk assessment and management, data protection, and guidance and supervision during the  import/export of LMOs as well as its domestic use.

In addition, the Law stipulates the mandates of the relevant institutions to assess, manage, inspect and control the potential risks of the LMOs.

The DPRK government, for the implementation of the Law, has adopted the Implementing Regulations of the Biosafety Law in May 2005 and has taken measures to prepare the necessary detailed rules of procedure and guidelines.

The Implementing Regulations prescribe that the National Biosafety Management Centre should be  set up to collect and manage the data necessary for biosafety management.

The DPRK has adopted the Interim Rules of Procedure of the Implementing Regulations of the Biosafety Law in November 2005 and promted its execution.  (to be continued )
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
The DPRK LMOs Safety Law is not applicabe to the export and import of the genetically modified pharmaceuticals as defined by the relevant international organization. If the LMO is imported to be used as raw material for making medicine, the import should be approved beforehand but it was not specifically stipulated in the Law.

Up to now there has been a tendency  in the area of pharmacy that regards the LMO is not suitable to be imported or looks at it with skeptical eyes and thus, any application for  importing LMO has not been filed. It is owing to the lack of understanding on biosafety in this area as well as of detailed specifications of such items in the Law.

Therefore, pharmaceutical branch should clearly define and classify the subjects to be put into the scope of the Law, raise the awareness of the officials working in this field and  improve their working system and competency through appropriate capacity building activities..
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
Although the Biosafety Law stipulates that the transit and contained use of LMOs should  be controlled, there are still no detailed provisions in the relevant regulations, rules of procedure and guidelines. Hence, this Article is  not yet implemented in this country.

The Law, above all, stipulates that when LMO makes trasit across the DPRK, all data necessary for biosafety management including its name, package and marking should be notified beforehand to the State Commission of Science and Technology.

The  DPRK is planning to make institutional arrangements to implement this Article and reflect in detail the requirements of this Article in the relevant rules of procedure,  working guidelines and terms of reference.

No LMO transit across the DPRK has been reported so far.

Secondly, the Law stipulates that any import of LMO for the purpose of scientific research or exhibition should be notifited to, and approved from, the Stae Commission of Science and Technology,  and if the LMO is intended for the contained use, it should be reported beforehand to the Biosafety Committee for its approval.

And if such contained use is approved, the LMO should be handled and used in accordance with the requirements of the contained use standards and operating norms as defined by the State Commission of Science and Technology.

The State Commission of Science and Technology requires that when making field experiment to assess the biosafety of salt-resistant GMO rice, certain isolation measures such as physical isolation, time isolation and biological isolation should be taken in the greenhouse or by using vinyl sheet.

There is a necessity for detailed and practical preparation of such specifications of standards, norms and procedures of this branch.

The relevant capacity building activites need to be supported to come up with it.

Exchange and cooperation with countries and international organizations with large amount of regional and international practical experiences would be favorable and conducive to the establishment and strengthening of the working system in this field and contribute to properly implement the Cartagena Protocol on Biosafety.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • No
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:
- Legislation

The DPRK Biosafety Law, the Implementing Regulations of Biosafety Law and the Detailed Rules of Procedure of Biosafety Law stipulate the application and approval procedures based on AIA and deal with transboundary movement of LMOs for the intentional introduction of LMOs into the environment.

At the preparation stage for bringing the Law into comprehensive enforcement in the DPRK, administrative measures focused on the AIA procedures are being taken in relation to the transboundary movement of LMOs for intentional introduction into the environment.

The relevant organs such as possible risk assessment institution, customs office and inspection and quarantine institution are not equipped with detailed rules of procedure,  working guidelines and terms of reference which are necessary to implement this Article.

The State Commission of Science and Technology is working hard to adopt such rules of  procedure and working guidelines for different branches and departments to implement the relevant provisions of this Article.

The Provisional Guidelines have been prepared to estimate the influence of the LMOs over human body, which is one of the successes achieved during the current reporting period.

The Provisional Guidelines is used not only for dealing with LMOs for intentional introduction into the environment, but also for handling applications for approval of LMOs intended for direct use as food or feed, or for processing(LMOs-FFP).

In order to complete and enforrce the law and regulations in this branch, it would be very helpful to develop and implement projects for the efficient implemention of NBFand capacity building, and share advanced knowledge and experiences with other countries and international organizations on regional and international scale.

- The AIA procedures

The procedures of fling application and granting approval for the intentional transboundary movement of LMOs for intentional introduction into the environment, and for the  intentional introduction of LMOs into the environment are as follows;

The application must be filed with to the State Commission of Science and Technology and approved by the Biosafety Committee.

Based on the filed application, the State Commission of Science and Technology undertakes the examination and classification of the documents and conducts the potential risk assessment of the filed LMOs,  and reports to the Biosafety Committee the results obtained through the consideration of departmental experts as well as its own comments and observation including biosafety management measures.

If the decision is made by the Biosafety Committee, the State Commission of Science and Technology records the results thereof  and notifies accordingly the applicant in written form.

- Monitoring of release into environment

  (to be continued in saparate sheets)
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?
  • No
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • No
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?
  • No
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • No
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:
This Article in the Protocol is considered to be the most important part as it takes the most significant proportion in the biosafety sector and deals with pratical issues.

The key issue in the establishment of biosafety management system on worldwide scale is deemed to lie in the improvement of the technical capacity to undertake the threshold evaluation and conduct the potential risk assessment.

Especially, the estimation of the effects of genetically modified agricultural products on the human body surfaces up as the priority issue.

During the current reporting period, the DPRK has put special efforts to the establishment of legal and administrative working system in this branch even though it is affected by the unfavorable conditions of the material and technical capacity including cases of lack of sicentific certainty on potential adverse effects of LMOs-FFP.

-Legislation

The Biosafety Law stipulates provisions for the domestic use of LMOs-FFP including for the purposes of their commercial use.

Although these provisions stipulate the application of the same AIA procedure of LMOs as defined for the release into the environment, they have not yet been detailed into the specific regulations, rules of procedure and guidelines to come up with the relevant requirements of this Aricle.

Some experts and officials consider  that the application of same procedure as in the case of the transboudary movement of LMOs for the intentional introduction into the environment is much more demanding than in the Protocol in terms of approval provision and thus, they  require that simplified procedures should be introduced..

Moreover, the thresholds definitions for the LMOs contained in the food or feed are not covered by the legislation, thereby causing many difficulties when handling genetically modifed food, feed and raw materials to be processed.

Accordingly, there arises a need to classify and prepare in detail the provisions regarding LMOs-FFP, and develop the specific regulations, rules of procedure, guidelines and thresholds respectively.

-Administrative working procedures

Taking into account the fact that the laws and regulations on export and import of LMOs-FFP  have not yet been completed, the DPRK government is now taking provisional measures.

Any case of import of LMOs-FFP is subject to prio approval of the Biosafety Committee.

The applicant must file the relevant application with the State Commission of Science and Technology and go through the risk assessment of LMOs. If any LMO-FFP is to be imported, the Ministry of Foreign Trade, the institution of inspection on exported/imported goods, the customs office and the finance and banking institution are allowed to proceed with the appropriate formalities only upon approval or granting from the Biosafety Committee and the State Commission of Science and Technology. (to be continued)
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
The Biosafety Law stipulates that if the applicant is notified of the rejection he or she can ask  to the Biosafety Committee within 60 days from the notification of rejection for the review of their decision, and the relevant decision making body should notify the applicant of the result of its review or reconsideration within 90 days.

To date, there has not been any application for the review in the case of the transboundary movement of LMOs.

The Biosafety Committee is undertaking to elaborate the relevant procedures and methods for the application, examination and notification of the results of  the review.
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?
  • No
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:
The Biosafety Law stipulates that the import and export procedures can be simplified on certain LMOs that are recognized as not having risks. But in that case, the risk assessment should be conducted to ensure the safety in law enforcement. For this, the AIA procedure should be applied at least once.

So far the DPRK has not yet experienced any application for the simplified procedures. In case of refined soybean oil, for example, which does not contain any LMOs even though it does not fall within the scope of the Cartagena Protocol,the AIA procedure is however currently being applied.

When the laws and regulations in this field are further specified in detail and updated, the simplified procedures will be applied to the LMOs which are recognized as riskless.
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:
Generally, according to the legal procedures for the transboudary movement of LMOs, the formalities are complicated and there is a concern about the potential risk thereof. That is why the officials in the relevant institutions including the importers are not willing to handle the LMOs.

The matter as to who should pay the risk assessment fees is not clearly stipulated in the Law and there are some dissatisfactions about the issue of providing the risk assessment data and sample, and the period of examination.

This clearly shows that it is absolutely necessary to further raise the public awareness in the area of the biosafety management.

For this reason, no data about bilateral, regional or multilateral agreements and arrangements have been submitted to the Biosafety Committee or to the State Commission  of Science and Technology during the current reporting period..
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • No
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • 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?
  • Not applicable
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Not applicable
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)?
  • Yes, always
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
93. Here you may provide further details on the implementation of Article 15 in your country:
The DPRK is trying to establish the legal and administrative working system for conducting the risk assessment before taking decisions on the LMOs.

The Law stipulates that the State Commission of Science and Technologhy is responsible for conducting the assessment of the potential risks of LMOs while the Biosafety Committee undertakes the consideration and decision on the LMOs.

The State Commission  of Science and Technology asks relavant institutions to conduct the assessment of the potential risks of LMOs before its import or export and is also organizing the work of estimation of LMOs' influence on the environment and human body according to the specific features and use purpose of the relevant LMOs.

In other words, the State Commission of Science and Technology selects the competent experts, arranges the risk assessment, analyzes its results and submits it to the Biosafety Committee.It is also taking necessary measures to ensure the biosafety management based on the results  of the risk assessment.

The State Commission  of Science and Technology examines, approves or instructs the Guidelines necessary for the risk assessment.  To estimate the influence of LMOs on human body, the State Commission  of Science and Technology has approved the Interim Guidelines for Hygienic Estimation of Genetically Modified Crops and sees to it that the risk assessment is conducted based on these Guidelines.These provisional Guidelines are recognized as one of the successes made in the process of enforcing the Biosafety Management Law and conducting the risk assessment of LMOs. Through the implementation of these Guidelines, experiences and knowledge will be gained and through capacity building in this field, the human resources and technical competency will be developed and intensified, thus contributing to update the Guidelines itself.

The State Commission of Science and Technology is undertaking the trial hygienic estimation of genetically modified anti-vermination maize (CryIA(c)), genetically modified albumen potato, genetically modified Virus X resistant potato, genetically modified Virus Y resistant potato, genetically modified salt-resistant rice and so on.

The State Commission  of Science and Technology is undertaking the assessment of the influence of LMOs on the environment. As any application for the risk assessment has not been filed, there is no experience in assessing the influence on the environment.

The Academy of Agricultural Science is preparing for trial estimation of of the influence of genetically modified crops on the environment based on the Interim Guidelines for the Assessment of the Influence on the Environment.

The State Commission  of Science and Technology is actively promoting the capacity building so as to be equipped with the risk assessment expertise.

The risk assessement is assumed as a vitally important issue in biosafety management  as no decisions can be made nor biosafety be managed withouth conducting the risk assessment.

Exchange and cooperation in this field with other countries and international organizations will contribute to the assessment and management of risks, to the establishment of national biosafety management system and to the implementation of Cartagena Protocol on Biosafety on a regional and global scale.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes, to some extent
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • 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:
The DPRK, starting from the principle of prevention, is undertaking the work to assess and manage beforehand the potential risks of the LMOs which can affect the biodiversity and human health.

The main principle undlerlying the biosafety management is to prevent the unintentional or illegal release of LMOs and adverse effects of LMOs on the ecological environment.

Based upon this principle, the DPRK governemt requires that the export and import as well as the use(research and development) of LMOs are allowed only under the condition that the risk assessment has been conducted and the management measures have been taken. It also puts up legal and administrative demands that the relevant safety management measures should be taken during the whole course of  dealing with LMOs.

In regard to the risk management, the Biosafety Law stipulates that the Biosafety Committee should approve the application for the import, export and use of LMOs after the risk assessment and examination thereof, but should prohibit, restrict and cancel the application if they are deemed to have adverse effects on the human health, biodiversity, and the social, econocmic and cultural development.

The Law also stipulates that the State Commission of Science and Technology should take relevant biosafety management measures in import, export, use, transportation, storage and  sales of LMOs and ask for the prescribed marks and packages, and if the there are damages, should take timely measures to prevent  them, and should abrogate, return, sterilize and disinfect in case of unintentional or illegal activities.

Accordingly, the Biosafety Committee demands to make appropriate marks and packages to prevent unintentional transboundary movement of LMOs and takes measures to ensure that any LMO undergoes an appropriate of observation during its lifecycle and generation time before it is put to its intended use.

So far, this country never experienced examples of import of LMOs for the intentional introduction into the environment or of introduction of LMOs into the environment in the border regions.

In the future, it will be necessary to classify in detail the LMOs-FFP, develop the guidelines and improve the practical abilities of the involved management officials and experts.

The Academy of Agricultural Science prepared the Interim Guidelines for Biosafety Management of the Academy of Agricultural Science" in December 2006 and made operational the Non-permanent Biosafey Committee of the Academy of Agricultural Science..  The Ministry of Public Health develped the Laboratory Biosafety Reference Book (revised edition)  in 2003 with the heand made it available in the field of public health.
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?
  • No
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
The State Commission of Science and Technology set up the State Biosafety Management Centre in 2005 and takes administrative measures to address any potential unintentional transboundary movement. But the research on checking the unintentional transboundary movement and taking measures to address them is at the basic stage.

In the future, it is necessary to further deepen the study on it and gain experiences in this area.
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?
  • No
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 Biosafety Law prescribes that in case of import and export of LMOs, the checking and quarantine should be based on the approved document of the Biosafety Committee.  Accordingly, the checking and quarantine institutions require that the importers and exporters must submit the correct declaration,  and check the approved document of import and export, packages and marks.

The import and export checking institutions are taking into consideration the methods of filling in the documents accompanying LMOs such as certificates of freight, hygiene check, plant check, quality control, place of origin, fund and bill. Practical measures are under consideration to identify non-LMO goods and LMO goods during the trasboundary movement of processed goods by using the identity preservation system of the relevant countries.

Now there is a concern and lack of understanding on the LMOs and goods containing LMOs in the field of export and import owing to the lack of scientific data which can prove the absolute safety of LMOs.

And the import and export regulations are so strict and check procedures are so complicated that most of importers and exporters are inclined not to treat LMOs.

Therefore, the data related to this Article for transportation, package and identification is not available so far.
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, some 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:
Following are the contact details of the national focal point for both Cartagena Protocol and Biosafety Clearing House who is responsible for liason  with the Secretariat of CPB and BCH whithin National Coordinating Committee for the Environment, DPR of Korea, which are also available in BCH: 

Name: Kim Chol Guk
Organization: National Coordinating Committee for the Environment(NCCE)
Address: Sungri Street, PO Box 44, Jungsong Dong, Central District, Pyongyang City
Country: Democratic People's Republic of Korea
E-mail: hyong.chol.ri@undp.org
Tel: +85 02 18111/ext.382 7222
Fax: +85 02 381 4699

The Competent National Authority representing DPR of Korea according to the request of the Cartagena Protocol on Biosafety is the National Coordinating Committee for the Environment(NCCE).

The NCCE is the govenmental organization which is undertaking the direct contacts with environment related  international organizations such as the United Nations Environment Programme and Convention on the Biological Diversity, and providing the unified coordination, consultation and decision making of the activities of the domestic stakeholders involved in the implementaion of the conventions and protocols of relation to the environment including biodiversity and biosafety.

The executing organization that is responsible for the implementation of the Cartagena Protocol in this country is the Biosafety Committee and its practical and technical work is mandated to the State Commission of Science and Technology.

The functions to be perfomed by the relevant stakeholders and line ministries which are participating to the biosafety management as well as the departmental guidelines are insufficient or missing and therefore have yet to be completed and updated in confirmity with the requirements of the developing situation.
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 but not 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 not available
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 but only partially available in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information not available
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?
  • No
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?
  • No
128. Has your country experienced difficulties accessing or using the BCH?
  • Yes
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Yes
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
- Status of the information submitted to the BCH or to the Secretariat of the Cartagena Protocol.

In this country, the national focal point of NCCE, DPRK keeps in touch with the BCH or the Secretariat of the Cartagena Protocol.

In 2004, the Interim Regulations for the Biosafety Management, Competent National Authority and National Focal Point of CPB and BCH have been informed to the Secretariat of the Cartagena Protocol.

As for the Biosafety Law of the DPRK which was adopted in December,2004 by  Decree No. 867 of the Presidium of the Supreme People's Assembly, it was not yet submitted to the CPB and BCH since its translation version is not yet available.

The Law dose not prescribe the specific provisions for the  import of LMOs-FFP but it stipulates the application of AIA procedure for both the LMOs and the products resulting therefrom.  It is planned to draw up in the future time the specific regulations and guidelines for the LMOs-FFP.

Now there have been no data about the application for the LMOs from foreign countries and international organizations and the decision made for the transit of the LMOs.

There is no data about the unintentional transboundary movement that may cause tangible adverse effects on on the biological diversity.

As the Government takes legal and administrative measures comprising the AIA procedures and promotes the raising of the awareness of officials involved in the import and export department, any illegal transboundary movement of the LMOs did not occur so far.

- Contacts

The NCCE ensures liason with the BCH and the Secretariat of the Cartagena Protocol via e-mail and fax and the like.

In the decision making process for LMOs, some data available in the BCH are being used, but there is some difficulties in the active use of the recent data.

- Exchange of data within the country.

Following the steps taken by the Government, the State Commission of the Science and Technology has set up the State Biosafety Management Centre and data exchange network to collect and manage data concerned with biosafety. As a result, the local website on the biosafety was developed and made operational.

The Ministry of Foreign Trade made pubic in its own website the import/export related data and is conducting the import/export formalities of LMOs via the electronic procedure system.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • In some cases only
134. Here you may provide further details on the implementation of Article 21 in your country:
The Biosafety Law specifies the  procedure to be follwed for the protection of the confidential information.

It requires that the State Commission of Science and Technology upon receipt of the application for the protection of the confidential information should check it and notify the results to the applicant.

It stipulates however that general data for risk assessment and for emergency measures such as contact details, and the information which is deemed to attract the social concern are not protected and even if the information falls within the confidential scope but is deemed to be necessary for the biosafety management, it should be made public. So far there has not been any application for the confidential information.

The cases eligible for the protection as the confidential information and the relevant detailed procedures for the protection are yet to be prescribed.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Multilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Difficult
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Building Capacity for Effective Participation in the BCH (Phase I)
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
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
Multichannelled cooperation has been conducted in DPRK to establish national biosafety framework and build the biosafety management capacity. The UNEP/GEF funded project on the Development of the National Biosafety Framework in DPRK was successfully implemented between 2002 and 2004 and the draft national biosafety framework was published.

The follow up project proposal on the Capacity-building for the Implementation of the National Biosafety Framework in DPRK has been submitted twice to the UNEP/GEF but it is not yet finally approved by GEF.

The UNEP/GEF project on the Builing Capacity for the Effective Participation in the BCH was initiated in 2005 but not yet completed.

It is important to strenghthen the capacity of biosafety management in order to make full operational and thouroughly implement the national biosafety framework.

A great deal of efforts have been channelled into consolidating the achivements already made and further developing the biosafety management in DPRK.

To this end, it is necessary above all to assess and meet the needs for capacity-building in detail:

Appropriate laws and regulations should be made in detail, organizational preparations improved and administrative work system and order completed. In particular, rules and regulations in different sectors are required to be made or amended in line with the developing situation and functions and working directives should be issued for agencies and institutions related to biosafety.

Training shoud be intensified to increase the number of officials and experts involved in biosafety management and improve their qualifications.

Information and knowledge on biosafety should be widely distributed to raise the public awareness and involve as many people as possible in this matter.

Scientific and technological foundations should be built to assess and manage the potential risks of LMOs.

It is also important to build emergency measures capacity to evaluate the effects of LMOs on human body, environment and socio-economic development and prevent damages from LMOs.

Supervision and control should be tightened to make people observe the laws and regulations on biosafety. To this end, inspection and identification of LMOs should be made on a higher level and proper procedures be established for liability and redress.

Bilateral and multilateral exchange and cooperation with other countries and international organizations on a regional and global scale will contribute to mutual exchange of successes and experiences gained in this sector and to the establishement of the global biosafety framework.

In particular, closer cooperation with international organiations including UNEP and GEP will be greatly helpful to building capacity for making full operational and implementing national biosafety framework
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, to a limited extent
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes, to a limited extent
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?
  • No
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to a limited extent
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
160. Here you may provide further details on the implementation of Article 23 in your country:
The Biosafety Law stipulates that the State Commission of Science and Technology, the press and media, the education institution, nature conservation agency and other related institutions should widely diffuse among the people the knowledge about LMOs by all means and take active part in the biosafety management.

It also requires tha the national BCH should be set up, data exchange network be formed to  ensure regular collection and exchange of information needed for LMOs managements. In particular, the LMO which is estimated to be safe should be be registered in the State Commission of Science and Technology and made public through national BCH.

In addition, the Law prescribes that all information about LMOs management, except confidential information, should be made public, which  include general information on the  risk assessment of LMOs, emergency measures for the preventation of accidents and other information that are recognized as of high public interests.

The State Commission of Science and Technology has conducted activities since 2002 to enhance public awareness of biosafety through national seminars and consultative meetings on the "Development of modern biotechnology and the issue of biosafety management", 'System for th risk assessment and management of LMOs', 'Legal and administrative system for the management of biosafety', and 'Public awareness of biosafety and public involvement system' in collaboration with UNEP and GEF.

In the educational sector biosafety was added to biotechnology and introduced in the curriculum as a subject on a trial basis.

'Biosafety' and other reference books were published, essays and reference information that deal with biosafety were published in 'Biology', 'Biotechnology Journal' and other magazines and a homepage on biosafety was set up at the State National Biosafety Management Centre to be used by experts in research institutes.

In the Ministry of Public Health 'Laboratory Biosafety Reference Book (second edition)' was published in 2003 in cooperation with  WHO.

Public awareness-raising activities have been conducted by way of introducing biosafety issues through TV and radio programmes and newspapers.

However, they lack scientific information on potential risks of LMOs and its effects, do not involve broad segments of people and are mostly spontaneous.
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?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
There is no bilateral, regional or mutilateral agreements between DPRK and non-Parties on the biosafety isssues.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
The Biosafety Law prescribes that the State Commission of Science and Technology and other relevant supervisory and control agencies are responsible for the supervision and control over the export and import of LMOs.

The Biosafety Committee and State Commission of Science and Technology have established temporary procedures for preventing illegal imports and exports of LMOs and checking LMOs and taken measures to build up their capacity.

- Temporary measures to prevent illegal imports and exports of LMOs include:

  In case of importing seeds, food and foddder, to require that declaration must be made on the existence or non-existance of LMOs in application form for approval and the correct guarrantee documents of the contractor should be accompanied or clearly stated in the contract, and then check the application documents.

- Temporary inspection procedures include:

To select and check the samples, conduct the identity test  if the LMOs are found, and take appropriate measures if they are not approved.

Inspection and quarantine institutions in DPRK have taken administrative measures for inspection and identification in order to prevent illegal transboundary movement of LMOs.

The implementataion of this Article involves the State Commission of Science and Technology, the State Quality Administration Commission, the State Biosafety Management Centre of the State Academy of Sciences, the Hygiene Institute of the Academy of Medical Science, the Agro-biology Institute of the Academy of Agricultural Science and other related institutions.
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?
  • Not applicable
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
178. Here you may provide further details on the implementation of Article 26 in your country:
The Biosafety Law stipulates that imports and exports of LMOs that are estimated to have negative impact on the social, economic and cultural progress shall be prohibited or restricted and if additional information is found on the negative effects of LMOs, the already-approved imports or exports of LMOs be cancelled.

So far neither applications for approval of imports or exports of LMOs have been made in  DPRK nor detailed rules and procedures set for the implementation of this Article. No study has been made to evaluate the effects on economic and cultural progress and no experience has been gained in this respect.

So, it is necessary to undertake research on this subject, set up in more detail the legal system and build up the capacity related to the assessment of socio-economic impacts.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • No
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
The Biosafety Law stipulates sanctions when the relevant procedures and orders including the AIA procedures are not observed, but does not mention about the appropriate criteria and procedures for implementing this Article.

Biosafety officials and experts appreciate that the adoption of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is one of great successes made in the global biosafety management sector.

However, there are a series of challenges in implementing this supplementary protocol.

First, officials in biosafety management sector have a poor understanding of liability and redress and lack the competent  knowledge and experience.

Therefore, opinions are raised that capacity-building activities should be planned including training courses to enhance awareness of this issue and give them expertise amd experiences. Consultative meeting is expected to be convened with the participation of the biosafety management officials and other stakeholders on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, Interim report only
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Lack of financial resources to gather the necessary information
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.
As was mentioned above, a great importance has been attached to biosafety and positive efforts have been directed to establishing biosafety framework in DPRK.

In future when national biosafety framework is fully set in motion and its capacity is built, people in all sectors will have a clear understanding of biosafety and the successes in biotechnology will contribute to preserving biodiversity and sustainable development of national economy

Re: Q. 14-

The government of DPRK has signed the Cartagena Protocol in April 2001 and ratified it in July, 2003 and started to become an active Party to the Protocol since October 2003.

In an effort to dully perform its responsibilties as a Party to the Cartagena Prtocol on Biosafety, the DPRK, above all, has enacted the provisional regulations in the area of biosafety followed by the adoption of the comprehensive Law on Biosafety. It also has put positive efforts to meet the demands of the Law.

The 2nd Conference of Parties to the Protocol held in Montreal, Canada in June 2005 highly appreciated the DPRK for its achievements of being one of the first countries to have finished the drafting of national biosafety framework among 134 countries that enjoyed the biosafety capacity-building activities initiated and sponsorede by  UNEP and GEF.

During the current reporting period, the DPRK government has been involved in the step-by-step implementation of the laws and regulations on biosafety to achieve the strategic  goals and priority targets specified in the National Biosafety Framework(NBF). At the   same time, the government also promoted the development of the components of the laws and regulations and building capacity.

In order to establish the system of administrative work in the branch of biosafety, the DPRK government put special efforts to properly appoint the National Focal Point and the Competent National Autyority of CPB and BCH, and then coordinate the activities of the stakeholders and assign their fuctions and formalities for biosafety management.

The DPRK yet has to bring the biosafety management system to completion and  regularize its operation. For that, it should update and complete the Law and Implementing Regulations  related to biosafety management, bring them into full enforcement, establish the working system and order of the Competent National Authority and other stakeholders and line ministries and promote the building capacity for strengthening their human and material resources.

This report reflects achievements and experiences gained in the course of bringing the Biosafety Law into force and implementing it together with some chanllenges to be addressed and tackled  in the days to come.