Democratic People's Republic of Korea | BCH-NR3-KP-113916 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

Loading...
Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)
  |  
BCH-NR3-KP-113916-1   |   PDF   |   Print   |  
last updated: 25 Oct 2018
General Information


National Coordinating Committee for Environment (NCCE), Biosafety Committee(BC), State Commission of Science and Technology(SCST), State Academy of Sciences, Ministrty of Land and Environment Protection, State Committee for Quality Control Administration, Ministry of Trade, Ministry of Agriculture, Ministry of Fisheries, Ministry of Health Affairs, Academy of Agricultural Sciences
EN

01 Dec 2011
28 Feb 2018
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is partially in place
EN
2005
EN
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
Yes, to some extent
EN
[The government is allocating a regular budget of funds for the memebers of the Secretariat of the non-permanent Biosafety Committee.]
EN
Yes
EN
Less than 10
EN
Partially
EN
The DPRK was highly appreciated in the 2nd Conference of Parties to the Protocol for its achievements of being one of the first countries to have finished the drafting of national biosafety framework with the support of UNEP.<br /><br />The Biosafety Law of the DPRK was adopted in December 2004 as Cabinet Decision No. 867 and was amended in December 2017. In order to implement the Law, the DPRK government adopted the Implementing Regulations of the Biosafety Law in May 2005 and Interim Rules of Procedure of the Implementing Regulations of the Biosafety Law in November and amended some articles in October 2011 and March 2015.<br /><br />Based on such legal foundations, a non-permanent biosafety committee led by State Commission of Science and Technology has been established. The committee is composed of 9 ministries and departments, such as State Academy of Sciences, Ministry of Agriculture, Ministry of Fisheries, Ministry of Public Health, Ministry of Land and Environment Protection, Ministry of External Economic Relations, State Commission of Quality Management, Academy of Agricultural Science, and Academy of Medical Science. This committee, whose secretariat is the State Commission of Science and Technology (SCST), is responsible for reviewing and coordinating major issues related to decision-making and management in biosafety field. <br /><br />As a secretariat of this non-permanent committee, the SCST is responsible for supervising and coordinating all sorts of practical and technical affairs related to national biosafety. It also conducts some practical work to perform its international obligations to implement the Protocol with close liaison to National Coordinating Committee for the Environment (NCCE), a national focal point of the Cartagena Protocol on Biosafety.<br /><br />The SCST makes a regular report to a plenary meeting of the non-permanent biosafety committee on its activities as a secretariat.<br />
EN
Article 5 - Pharmaceuticals
No
EN
The Biosafety Law stipulates that it exempt from the application of the Law the import and export of LMOs that are pharmaceuticals for humans addressed by relevant international organizations.
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
No
EN
Firstly, the Law stipulates that when LMOs make transit across the DPRK, all data necessary for biosafety management including its name, quantity, package, marking, departure and arrival place, transportation etc. should be notified beforehand to the State Commission of Science and Technology and exempts transport of LMOs which are not packaged. <br />Secondly, it allows contained use of LMOs for the purpose of scientific research or exhibition, which requires prior approval from and supervision by the SCST. And such contained use should be conducted in accordance with the requirements of the contained use standards and operating norms as defined by the SCST and be regularly supervised by the SCST.<br />
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
None
EN
None
EN
The DPRK Biosafety Law strictly prohibits the import and export of plant seeds. It has designated the State Commission of Science and Technology as a national organization that controls the transboundary movement of LMOs.<br /><br />According to this, in order to import and export LMOs for intentional introduction into the environment, an application should be filed with to the SCST and the applicant is legally responsible for the correctness of the applied information. In such case, the information of the import and export application and the procedures for receipt of notification or approval, unless specifically stipulated, should follow the provisions and annexes of the AIA of the Cartagena Protocol on Biosafety as they are.<br /><br />In such case in which the scientific clarification on potential adverse effect of intentional introduction of LMOs into the environment is insufficient, the SCST shall not allow the import and export of the applied LMOs.<br />
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Less than 10
EN
Less than 5
EN
Less than 10
EN
No
EN
No
EN
In accordance with the Biosafety Law, import and export of living modified organisms intended for direct use as food or feed, or for processing shall be informed to SCST together with a written application and guarantee of the importer or exporter for direct use as food or feed, or for processing. The applicant shall ensure the accuracy of information provided for the SCST.<br /><br />The SCST may take a decision on the import of LMO-FFPs based on the applied information and through Biosafety Clearing-House and inform the BCH of the LMO-FFPs that are approved of export.<br /><br />In case scientific certainty is insufficient, regarding the extent of the potential adverse effects of a living modified organism intended for direct use as food or feed, or for processing, the SCST may reject the transboundary movement of the applied LMOs.<br />
EN
Article 12 – Review of decision
Yes
EN
No
EN
No
EN
None
EN
The Biosafety Law stipulates that the applicant such as institutions, enterprises, organizations and private person, who is notified of the rejection of research and development, production, and import and export, can require the SCST to review a decision within 60 days from the notification of rejection, and the SCST should notify the applicant of the result of its review or reconsideration within 90 days from the receipt of the request.<br /><br />The SCST also may cancel the approval of research and development, production, and import and export of living modified organisms in such circumstances provided:<br />a) new scientific information on potential adverse effects of LMOs which have previously approved of research and development, production, and import and export on human health and the conservation and sustainable use of biological diversity, taking also into account social, economic and cultural development;<br />b) approval of research and development, production, and import and export of LMOs by devious means or other unfair ways; or<br />c) use of the LMOs for different purpose and content from the approved ones.
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
The Biosafety Law has not specified any simplified procedures for the transboundary movement of LMOs.
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
During the current reporting period, DPRK has never entered into bilateral, regional and multilateral agreements and arrangements under Article 14.
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes
EN
Yes
EN
10 or more
EN
50 or more
EN
10 or more
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
Yes
EN
  • LMOs for direct use as food
No
EN
Yes, always
EN
5 or less
EN
Yes, to some extent
EN
Yes
EN
Yes
EN
The Law stipulates that decisions on all kinds of living modified organisms shall be taken based on risk assessment and management plan.<br /><br />Such risk assessment and management plan is organized by the State Commission of Science and Technology and the results should be submitted to the Biosafety Committee. The SCST asks relevant institutions to conduct risk assessment and draw up a risk management plan according to the specific features and use purpose of the relevant LMOs. It may ask the other institutions for re-assessment unless the results are sufficient.<br /><br />During the current reporting period, the SCST has approved the Interim Guidelines for Hygienic Estimation of Genetically Modified Crops and, based on these Guidelines, has conducted trial risk assessment and drawn up a risk management plan for genetically modified salt-resistant rice, genetically modified virus-resistant potato, genetically modified albumen potato, genetically modified anti-vermination maize and so on. Through experiences and successes made in the process, the SCST regularly organizes training on risk assessment and management and just the trainees who pass are qualified for the risk assessment and management. However, as the training addresses only limited LMOs and the level of neither the trainers nor the training material is adequate, it is difficult to select a competent institution to conduct risk assessment and management in a proper way.<br />
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
Yes
EN
Never
EN
During the current reporting period, any unintentional transboundary movement of LMOs which are likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, has been neither notified nor identified.<br /><br />If such unintentional transboundary movement happens, the SCST calls an emergency meeting of non-permanent Biosafety Committee and takes administrative measures to a great extent. However, it has not yet properly established a mechanism to inspect and supervise unintentional transboundary movement of LMOs and has lack of techniques for determining appropriate responses and initiating necessary actions, including emergency measures.<br />
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN
Yes
EN
Existing or a stand-alone document
EN
Yes
EN
Existing or a stand-alone document
EN
Yes
EN
Existing or a stand-alone document
EN
Yes
EN
Yes
EN
10 or more
EN
Yes
EN
10 or more
EN
Yes
EN
10 or more
EN
One or more
EN
Based on the DPRK Biosafety Law, the SCST has developed and approved provisional regulations on production, package, transport and research of LMOs, in accordance with Article 18 of the Cartagena Protocol on Biosafety.<br /><br />The regulations prescribe that LMOs should be developed and handled, taking into consideration relevant standards, and be packaged and transported with appropriate labels or marks including information specified in the regulations.<br />
EN
Article 19 – Competent National Authorities and National Focal Points
n/a
EN
Yes, to some extent
EN
The national focal point of the DPRK for the Cartagena Protocol is the National Coordinating Committee for the Environment (NCCE). The NCCE is the governmental organization which makes direct contacts with relevant international bodies such as United Nations Environment Program, Convention on Biodiversity and etc. It provides unified coordination, consultation and decision making for activities of domestic stakeholders involved in the implementation of the conventions and protocols related to the environment including biodiversity and biosafety.<br /><br />The administrative and practical work for national biosafety is mandated to non-permanent Biosafety Committee and, as its secretariat, the State Commission of Science and Technology manages and coordinates LMO-related practical work and makes a regular report to the Biosafety Committee.<br />
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information available but only partially available in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
No
EN
Yes
EN
Yes, in some cases
EN
Yes
EN
No
EN
One or more
EN
10 or more
EN
  • National website
  • National Libraries
The Biosafety Law stipulates that the SCST shall set up a database of LMOs and inform and disseminate necessary data concerned with biosafety through a data exchange network.<br /><br />In order to disseminate scientific knowledge of LMOs and provide necessary information for transboundary movement, production, research and development of the LMOs, the SCST is operating a national biosafety clearing-house and making a homepage available on a trial basis. The information has already been submitted to BCH partially, but it is available only on the National website due to technical insufficiency of infrastructure or data organizers.<br /><br />The non-permanent Biosafety Committee is about to ensure real-time contact with the nBCH and the BCH via the Internet in the near future so that any Party of import and export can have access to the information related to biosafety.<br />
EN
Article 21 – Confidential information
Yes
EN
In some cases only
EN
Under the Biosafety Law, the applicant may require the SCST to protect the confidential information applied. Then the SCST upon receipt of the application for the protection of the confidential information should consult it if such treatment is qualified and notify the applicant of its decision. If not, it should provide reasons on the request for the applicant.<br /><br />In case the information which is qualified as confidential and to be protected is considered to be necessary for the biosafety management, the SCST can make it public only after consultation with the applicant. Not consulted information can not be made public.<br /><br />The SCST supervises and controls the requested institutions for risk assessment not to disclose or use without any approval the information gained in managing and handling the LMOs.<br />
EN
Article 22 – Capacity-building
No
EN
Yes
EN
Multilateral channels
EN
No
EN
Yes
EN
Difficult
EN
  • Building Capacity for Effective Participation in the BCH (Phase I)
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
  • Handling of confidential information
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
No
EN
Yes
EN
  • 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
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
No
EN
No
EN
1 per year or more
EN
No
EN
Since national biosafety framework was established in DPRK funded by UNEP/GEF between 2002 and 2004, capacity building activities for biosafety have been conducted under supervision of the non-permanent Biosafety Committee. The capacity building has been undertaken mainly for risk assessment and management, and identification and detection of LMOs. However, due to lack of the advanced technology and insufficient infrastructure, those areas still need building capacities.<br /><br />In particular, the follow up project proposal on the “Capacity building for the Implementation of the National Biosafety Framework in DPRK” submitted to the UNEP&nbsp; has not been approved yet for 10 years and the project on the Building Capacity for the Effective Participation in the BCH (Phase I) has not been yet completed, either. Likewise, international cooperation for capacity building in biosafety is abandoned more or less incomplete in DPRK.<br /><br />Considering that the biosafety issue is not merely a national matter but a regional and international matter that can directly affect the ecosystem of adjoining countries, in particular, taking also into account that the increase of agricultural products comes to the fore as one of important development goals in DPRK, the international cooperation for capacity building in biosafety is to be prioritized irrespective of any conditions.<br />
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Not applicable
EN
Yes
EN
One or more
EN
Yes, to some extent
EN
Yes, to some extent
EN
Yes
EN
Yes, to some extent
EN
  • National website
National website
EN
No
EN
3 or more
EN
None
EN
No
EN
Never
EN
Public awareness and participation regarding biosafety in DPRK is promoted and facilitated by the national BCH through the biosafety database on the National website. The online biosafety database contains a great deal of information which can arouse public interest for biosafety including Korean editions of the Convention on Biodiversity and the Cartagena Protocol on Biosafety, and the results of experiment or research in biosafety management. Those who are interested in biosafety can make access at any time to the information which is not identified as confidential such as concerning LMO production, transfers, handling, package and use, through the aforementioned database.
EN
Article 24 – Non-Parties
No
EN
No
EN
No
EN
In the current reporting report, the DPRK has never entered into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding transboundary movements of LMOs.
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Never
EN
The Biosafety Law prescribes that in the case of an illegal transboundary movement of LMOs, appropriate institution should immediately declare it to the SCST.<br /><br />The SCST considers the correctness of the declaration and disposes of the LMOs in question. Labour, materials and expenses for disposing should be afforded by appropriate units and enterprises involved in such illegal transboundary movements.<br /><br />In case transboundary movements of LMOs are carried out in contravention of the provisions of the Biosafety Law, such movements are fined as indicated by relevant national authorities.<br />
EN
Article 26 – Socio-economic considerations
Yes
EN
Only in some cases
EN
None
EN
None.
EN
No
EN
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. Such negative impacts are examined and assessed by the non-permanent Biosafety Committee.
EN
Article 27 – Liability and Redress
No
EN
Yes
EN
No
EN
Yes
EN
Since 2017, the DPRK has been consulting with stakeholders to ratify the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. In the consultative meetings, the stakeholders have agreed that the existing Biosafety Law does not clearly specify provisions on liability and redress and lack of human and technical resources, owing to the discontinued international cooperation for the last 10 years, is checking the implementation of the Supplementary Protocol. In this regard, they have seen to it that study on obligations, rights and regulations for implementing the Supplementary Protocol under the country’s social and economic conditions should be intensified by revitalizing capacity building activities within the limit of international cooperation for the implementation of the&nbsp; Cartagena Protocol. Such activities will bring the outcomes of approval of national legislations on liability and redress and provide foundations for ratification of the Supplementary Protocol.
EN
Article 28 – Financial Mechanism and Resources
50,000 USD or more
EN
Article 33 – Monitoring and reporting
Yes
EN
Yes
EN
No
EN
  • Lack of financial resources to gather the necessary information
Other information
The DPRK is now directing some positive efforts to biosafety, however, since international assistance has been discontinued for the last 10 years, the implementation of the Cartagena Protocol is being checked by following challenges:<br />(a) Shortcomings of technical resources for identification detection, risk assessment and risk management of LMOs;<br />(b) Insufficient advanced equipment for identification and detection of LMOs;<br />(c) Lack of advanced knowledge on LMOs which are internationally developed, produced and popularized; and<br />(d) Public and stakeholders’ indifference to biosafety<br />
EN
Comments on reporting format
No.
EN