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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102327
Status
Published
Date of creation
2011-09-22 01:31 UTC (bch@env.go.jp)
Date of publication
2011-09-22 01:31 UTC (bch@env.go.jp)

Origin of report
Country
  • Japan
Contact officer for report
Coordinates
Mr. Masaki Ushiba
Director
Alien Species and LMO Regulation office, Wildlife Division, Nature Conservation Bureau, Ministry of the Environment (MOE)
1-2-2 Kasumigaaseki
Chiyodaku, Tokyo
Japan, 100-8975
Phone:+81-3-3581-8344
Fax:+81-3-3581-7090
Email:bch@env.go.jp
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Japanese seven government ministries responsible for the implementation of the Cartagena Protocolon Biodiversity
Submission
10. Date of submission
2011-09-22
11. Time period covered by this report
Start date
2007-05-01
Time period covered by this report
End date
2011-09-21
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 fully 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?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
Japanese seven government ministries responsible for the implementation of the Cartagena Protocol on Biosafety are full-time staffed and secure a budget to operate the domestic law for the implementation of the Protocol.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
Under the domestic law for the implementation of the Protocol, biological diversity risk assessment regarding domestic use of LMOs including which are pharmaceuticals for human is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, and approval is given if it is recognized that there is no possibility of adverse effect on biodiversity. However, LMOs which are pharmaceuticals for human are excluded from stipulation on notification of export and indication for export.
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?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
Under the domestic law for the implementation of the Protocol, the domestic uses of LMOs with containment measured to prevent to disposal of LMOs in the environment are possible when the containment measures are stipulated in the ordinance of the competent ministries or confirmed in advance by the competent minister.
   Japan does not regulate the transit of LMOs.
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?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
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?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 5
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
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?
  • Less than 5
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?
  • Less than 5
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes, always
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • Yes, always
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • Yes, always
48. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) without conditions
100%
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • Not applicable
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:
Under the Protocol and its relevant domestic law, biological diversity risk assessments had been carried out regarding use of two LMOs (pharmaceutical to be used solely for animals, cotton).  Approvals for these two were given without condition during the current period by the Japanese government. Accordingly, BCH was notified to the effect that two LMOs were approved.
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?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • None
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • No
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, always
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:
Under the domestic law for the implementation of the Protocol, biological diversity risk assessment regarding domestic use of LMOs intended for direct use as food or feed, or for processing is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, and approval is given if it is recognized that there is no possibility of adverse effect on biodiversity. When Japanese government  approved LMOs, the information of the LMOs has been notified to the BCH with relevant information.
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:
Japan has not reviewed/changed a decision regarding an intentional transboundary movement of LMOs.
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:
Japan has not used simplified procedure.
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:
Japan has not entered into any agreement or arrangement in question.
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?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
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?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
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?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • In some cases only
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?
  • More than 10
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?
  • No
93. Here you may provide further details on the implementation of Article 15 in your country:
Under the domestic law for the implementation of the Protocol, persons who wish to use new LMOs in the environment (developers and importers, etc.) must carry out a prior risk assessment of adverse effect on biological diversity in accordance with the Guidance of Implementation of Assessment of Adverse effect on Biological Diversity. The competent ministers may grant approval when recognizing, taking account of the content of consultation with experts, that no adverse effect on biological diversity could arise. Persons who wish to export LMOs to Japan from a foreign country and to make them used in Japanese environment, may appoint a Domestic Manager who has an address in Japan and obtain such approval.
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
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?
  • Yes
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:
Under the domestic law for the implementation of the Protocol, persons who wish to use new LMOs in the environment (developers and importers, etc.) must carry out a prior risk assessment of adverse effect on biological diversity in accordance with the Guidance of Implementation of Assessment of Adverse effect on Biological Diversity. The competent ministers may grant approval when recognizing, taking account of the content of consultation with experts, that no adverse effect on biological diversity could arise. Persons who wish to export LMOs to Japan from a foreign country and to make them used in Japanese environment, may appoint a Domestic Manager who has an address in Japan and obtain such approval.
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?
  • Yes
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:
No such case has been reported.
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
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
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
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
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
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
The domestic law for the Protocol stipulates that the package, vessel and invoice, etc. of LMOs intended for export to a Party must be accompanied by the descriptions of the required specific matters. Their specific formats are set forth in the Regulations of the Law. What has to be described differs, based on the provision of the Protocol, depending upon whether they are LMOs intended for contained use, or LMOs intended for use as food or feed or for processing, or LMOs intended for other use.
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
123. Here you may provide further details on the implementation of Article 19 in your country:
Japan has been providing relevant information to the BCH.
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 available and in the BCH
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 available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
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 available and in the BCH
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 available and in the BCH
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 available and in the BCH
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?
  • Yes, in some cases
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:
Any information required to be made available to the BCH under the Protocol has been directly conveyed to the BHC through its management center. As an equivalent to BCH at national level, the Japanese version of the Biosafety Clearing-House (J-BCH) is operated, where information on the Protocol and Japanese legislation as well as database on LMOs approved in Japan are posted. On the website, information on the legal mechanisms under Japanese legislation and on LMOs (the usage of LMOs approved in Japan and the outlines of risk assessments) are also available in English.
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?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
Under the domestic law for the implementation of the Protocol, when biological diversity risk assessment regarding domestic use of LMOs is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, confidential information identified by the applicant is to be treated as nondisclosure and the person involved is to be required not to divulge the information.
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?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Multilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
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?
  • 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
  • Scientific biosafety research relating to LMOs
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?
  • No
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?
  • Yes
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:
Japan has been contributing financial resources to the GEF, which has been implementing a number of projects to build capacity on biosafety.
Six Japanese experts are inscribed on the Roster of Experts posted on the BCH.
Japan supported the Third International Meeting of Academic Institutions and Organizations Involved in Biosafety Education and Training held in Tsukuba, Japan in February2010.
Japan has been contributing financial resources to the SCBD to support a number of projects on capacity building activities under the Cartagena protocol on Biosafety.                                                    ]
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
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?
  • 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?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
Information on LMOs including the status of development and uses of LMOs in Japan is made available on the websites of the ministries concerned and J-BCH.
Furthermore, access to the information posted on the BCH is facilitated through links to the BCH.
In approving the use of LMOs in the environment, the outline of the Biological Diversity Risk Assessment Report as well as the content of consultation of the experts on the application concerned are released for public comments and the outcome of the decision is also released on J-BCH and other relevant websites.
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?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • Yes, always
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:
Japan imports LMOs-FFP and LMOs intended for contained use from Non-Parties. A person who wishes to use LMOs in the environment in Japan (including the distribution of living seeds as food or as feed) must obtain approval under the domestic law for the Protocol. Therefore, any LMO that has not been approved in Japan can not be used in the environment even if it is imported from a Non-Party.
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?
  • Less than 10
171. Has your country informed the BCH and the other Party(ies) involved?
  • Only in some cases
172. Has your country established the origin of the LMO(s)?
  • Yes
173. Has your country established the nature of the LMO(s)?
  • Yes
174. Has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes, some cases
175. Here you may provide further details on the implementation of Article 25 in your country:
In the current reporting period, Japanese government received information about five cases of illegal import of LMOs (killifish, zebra danios, corn, papaya, pharmaceuticals for human). those cases about killifish, zebra danios and corn happened because the importer had not recognized that those LMOs were genetically modified. To prevent adverse effect on biological diversity, Japanese government took measures such as recall or disposal of the LMOs and required importers to take preventive steps. The cases about papaya and pharmaceuticals for human are currently under factual investigation of the illegal transboundary movement.
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
178. Here you may provide further details on the implementation of Article 26 in your country:
No decision has been taken.
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:
Signature on the Nagoya-Kuala Lumpur Supplementary Protocol is under consideration by Japanese government.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
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
  • 2004
Here you may provide further details
The aim of funding (2011-12) from the Ministry of Agriculture, Forestry and Fisheries (MAFF) to the Secretariat of the Convention on Biological Diversity (SCBD) was to contribute to the implementation of the capacity building activities under the Cartagena Protocol on Biosafety.    -Amount  2011FY: 358,695USD  2012FY: 337,786USD    The aim of funding (2011-12) from the Ministry of Environment (MOE) to the SCBD was to contribute to the implementation of the capacity building activities under the Cartagena Protocol on Biosafety.    -Amount  2011FY: 272,669USD  2012FY: 203,400USD
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 10 per year or more
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
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
  • 1,000,000 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
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
  • Yes
Survey 9.b) Risk management
  • No
Here you may provide further details
Domestic Laws and Regulations of Japan are as below;  http://www.bch.biodic.go.jp/english/law.html
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
  • Yes
Here you may provide further details
Domestic Laws and Regulations of Japan are as below;  http://www.bch.biodic.go.jp/english/law.html
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
  • Yes
Here you may provide further details
Approved LMOs are as below;  http://www.bch.biodic.go.jp/english/lmo.html
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
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
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
  • Yes
Here you may provide further details
Domestic Laws and Regulations of Japan are as below;  http://www.bch.biodic.go.jp/english/law.html
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
Japan has no experience in taking socio-economic considerations into account in LMO decision making.
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
  • Yes
Here you may provide further details
Japan has experienced the case of GM Papaya found illegally planted in the part of Japan.    See the detailed information in the following URL;  http://bch.cbd.int/database/record.shtml?documentid=103897
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
  • 100 or more
Survey 19.b) Monitoring
  • 100 or more
Survey 19.c) Management / Control
  • 100 or more
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
Japan has implemented monitoring for papaya and linseed for the purpose of preventing the import/distribution of GM crops without approved for use.
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
  • No
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
  • No
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 100 or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • 5 or more
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • 5 or more
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
  • No
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
  • Yes
Here you may provide further details
Japan has legal instrument that provides for taking measures, such as recalling living modified organisms, when it is found that adverse effect on biological diversity resulting from living modified organisms has occurred.    See the detailed information in the following URL;  http://www.bch.biodic.go.jp/english/law.html
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
Japan informs the public about existing modalities for public participation in the decision-making process regarding some living modified organisms.
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
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 10 or more
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
  • Yes
Survey 35.b) Enforcement system
  • Yes
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
  • One or more
Here you may provide further details
The legal seminars for research managers in Japan (organized by Ministry of Education, Culture, Sports, Science and Technology)  20 May 2013  11 June 2012    Workshop on the Implementation of  the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress, Tokyo, Japan  21 February 2013    This workshop was organized by Ministry of Agriculture, Forestry and Fisheries as international event (Invitation only) to identify the key challenges facing the Parties to the Cartagena Protocol in the domestic implementation of the NKL-SP, and to provide possible solutions to overcome those challenges.
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
  • 100 or more
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National Libraries
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
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
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
  • None