At the University, when implementing experiments involving genetic modifications, measures must be implemented to both prevent the release of genetically modified material into the environment, and to ensure the safety of the experiment. The regulations contained in the Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartagena Act), and all related laws, must be strictly adhered to.

○On-campus rules

Rules on the Safety Management of Experiments involving genetic modification at Kyushu University
Regulations on the Safety Management of Experiments involving genetic modification

○Training

Individuals wishing to conduct experiments involving genetic modification must receive training beforehand. After that, individuals must also attend a re-training program every five years.No person is allowed to engage in an experiment without receiving training.

○Procedure for approval of genetic modification experiments

To conduct experiments involving genetic modification, approval from the president is required beforehand. The responsible personnel of experiments involving genetic modification prepare a design for the experiment and after screening and approval by the senior safety administrator of the department, the design for the experiment needs to be submitted to the president through the head of the department. The design for the experiment is to be screened by the designated genetic modification experiment safety committee which is designated by the president, and the result of the screening is to be notified to the responsible personnel of experiments through the head of the department.
Only faculty members of the University (professors, associate professors, lecturers, assistant professors, and research associates) can be personnel responsible for experiments involving genetic modification.

At Kyushu University, applying for and changing the designs of experiments involving genetic modification can be done via an electronic application system. Please use the system below.

Experiments involving genetic modification are clarified as Minister-confirmed experiments and Organization-approved experiments. If the experiment falls into the category of Minster-confirmed experiments, please be advised that after screening by the genetic modification experiment safety committee, the experiment needs to be confirmed by the Minister of Education, Culture, Sports, Science and Technology.

• ・Minister-approved experiments
  Covers genetic modification experiments detailed in Appended Table 1 (related to Article 4) of the “Regulations defined to prevent dispersal during the use of type 2 genetically modified organisms during research and development.”
• ・Organization-approved experiments
  All experiments other than those described above.

In the case of conducting experiments using animals such as mammals, birds and reptiles, the application for animal experiments needs to be submitted and approved by the president. (Animals belonging to the category of amphibians and fish are treated the same as mammals, birds, and reptiles.)

○Procedure for approval of laboratories for genetic modification experiments

If an experiment involving genetic modification falls under any of these experiments - P2 or above, mass incubation experiments, experiments using animals or plans - it needs to be done at laboratories approved by the president. Please submit the application for approval of containment measures, the floor plan of the laboratory and outline of the inside of the facility to the president through the head of the department (chief administrator) who manages the facility for the experiment. The genetic modification experiment safety committee designated by the president conducts screening and notifies of the result to the head of the department.
Only faculty members of the University (professors, associate professors, lecturers, assistant professors, and research associates) can be personnel responsible for the management of the laboratories under the chief administrator.

In the case of caring for and keeping experimental animals such as mammals, birds, and reptiles, and of managing them at laboratories, approval is needed for the experimental animal facilities or Biomedical Experiment Institute. (Animals belonging to the category of amphibians and fish are treated the same as mammals, birds, and reptiles.)

At Kyushu University, applying for and changing the application for laboratories for experiments involving genetic modification can be done via an electronic application system. Please use the system below.

○Procedures relating to the commissioning or subcontracting of genetically modified organisms

• 　The following procedure is needed when handing over genetically modified organisms, etc.
  1. The transferrer makes sure that the transferee has a clear plan and a proper management system set up in advance.
  2. Notify of the information regarding the genetically modified organisms, etc. in a written form, etc.
  3. Within two weeks of the hand-over, submit a hand-over report to the president through the head of the department.


• 　The following procedure is needed when receiving genetically modified organisms, etc. from outside the University.
  1. Approval for experimental plans for the use of genetically modified organisms, etc. is needed in advance.
  2. Accept the information regarding the genetically modified organisms, etc. in written form.
  3. Within two weeks of the take-over, submit the take-over report to the president through the head of the department.

At the University, there are forms available on the “Experiments involving genetic modification at Kyushu University” website such as the document regarding the transfer of genetically modified organisms and a confirmation document for accepting genetically modified organisms.

○Major systems which require additional application when conducting experiments involving genetic modification

• 1. When animal experiments are involved
  When animal experiments are involved, design for the animal experiment needs to be submitted and approved by the president in advance.


• 2. When installing equipment in a laboratory that requires notification to the Labor Standards Inspection Office. (Including when changes need to be made)
  Notification may be required to the appropriate Labor Standards Inspection Office when installing equipment such as autoclave (pressure vessel), local exhaust ventilation (draft chamber) and an X-ray machine in a laboratory. Please submit the notification through your department office.

○Procedures for the export of genetically modified organisms

When exporting genetically modified organisms, in addition to the procedures mentioned in 1,2 and 3, information regarding the organism to be exported must be provided to the exporting destination using form No.12 defined in Article 37 of the “Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Modified Living Organisms”. When importing genetically modified organisms, please use the same procedures for the take-over from outside the University mentioned above. On the Material Management Center website, necessary documents for handover and takeover can be filled out and submitted.

○Procedures for experiments involving genetic modification and approval for the relevant facilities

・Electronic application system for experiments involving genetic modification
https://revisp.jimu.kyushu-u.ac.jp/

○Manuals, etc.

・Policy regarding experiments involving genetic modification at Kyushu University