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.

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.

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.<br />&nbsp;&nbsp; Japan does not regulate the transit of LMOs.

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).&nbsp; 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.

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&nbsp; approved LMOs, the information of the LMOs has been notified to the BCH with relevant information.

Japan has not reviewed/changed a decision regarding an intentional transboundary movement of LMOs.

Japan has not used simplified procedure.

Japan has not entered into any agreement or arrangement in question.

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.

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.

No such case has been reported.

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.

Japan has been providing relevant information to the BCH.

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.

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.

Japan has been contributing financial resources to the GEF, which has been implementing a number of projects to build capacity on biosafety.<br />Six Japanese experts are inscribed on the Roster of Experts posted on the BCH. <br />Japan supported the Third International Meeting of Academic Institutions and Organizations Involved in Biosafety Education and Training held in Tsukuba, Japan in February2010. <br />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.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; ]<br />

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.<br />Furthermore, access to the information posted on the BCH is facilitated through links to the BCH. <br />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.

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.

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.

No decision has been taken.

Signature on the Nagoya-Kuala Lumpur Supplementary Protocol is under consideration by Japanese government.

Japan has no experience in taking socio-economic considerations into account in LMO decision making.