Biosafety Guidelines For Research On Genetically Modified ...

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3.2 FLOW CHART FOR IMPORTATION OF GMOs FOR RESEARCH (Applicable to GMOs falling under Category A and/or B) Note that importation or possession of GMOs, not relating to human health, is regulated under Section 9 of the Animals and Birds Act (Cap 7). Additionally, importation or procurement to import specific biological agents and toxins, which is capable of causing death, disease or malfunction in a human, as those specified under First, Second, Fourth and Fifth Schedules, is regulated under the Biological Agents and Toxins Act (Act 36 of 2005). Principal Investigator Submit ‘Proposal Form for Assessment of Genetic Modification Work’ to the IBC. The template Proposal Form and instructions for completing the form can be found in the GMAC Biosafety Guidelines for Research, Appendix 3. Reject or Request for more information Institution Biosafety Committee (IBC) Assess proposal IBC may seek GMAC’s advice, if necessary IBC Approval Principal Investigator Submit copy of proposal and IBC’s assessment to relevant regulatory agency Reject or Request for more information Regulatory Agency Process the request and ensure the necessary documents are in order. If necessary, Agency may require further assessment from GMAC or other assessors. Approval given Regulatory Agency Issue the necessary documentation, Inform GMAC of decision(s) Principal Investigator Apply for import permit through Tradenet [http://www.tradenet.gov.sg/trdnet/index_home.jsp]. Furnish necessary documentation. Page 7
3.3 CATEGORY A – EXPERIMENTS REQUIRING IBC APPROVAL AND GMAC NOTIFICATION (REGULATED EXPERIMENTS WITH SIGNIFICANT RISKS) Please refer to Section 4.1 for a description of experiments falling into Category A. Experiments in this category require both IBC assessment and GMAC notification prior to commencement. Principal investigators should not commence work on proposals assessed as Category A until advised by their IBC, which will not transpire until the IBC receives acknowledgement of GMAC notification. Principal Investigators intending to conduct experiments classified as Category A should submit a ‘Proposal Form for Assessment of Genetic Manipulation Work’ to their respective IBCs for assessment. The IBC shall assess the proposal and determine the appropriate working and containment measures and facilities necessary. A proposal in this category should be submitted by the Principal Investigator to the IBC for assessment on a GMAC ‘Proposal Form for Assessment of Genetic Manipulation Work’. The IBC should assess the proposal and determine the appropriate working and containment conditions. Upon approval, the IBC should forward the proposal to the GMAC secretariat, together with a summary of the IBC’s recommendations or comments, for notification. Instructions for filling out the forms are included in Appendix 3. When completing the forms and assessing the experiments, the IBC and the investigator should identify potential hazards and their types, and decide upon any special procedures necessary for the proposed experiments. The GMAC Secretariat will return a copy of the GMAC ‘Proposal Form for Assessment of Genetic Manipulation Work’, carrying a GMAC case reference number, to the IBC within 10 working days to acknowledge receipt of the proposal. The case reference number should be quoted in all future correspondences relating to the proposal. The acknowledgment of receipt does not imply GMAC’s acknowledgement or endorsement of IBC’s decision. Work must not commence until GMAC has released its acknowledgement and/or endorsement to the IBC. 3.4 CATEGORY B – EXPERIMENTS REQUIRING IBC APPROVAL (NOTIFIABLE EXPERIMENTS WITH LOW RISKS) Please refer to Section 4.2 for a description of experiments falling into Category B. Experiments in this category require assessment by the IBC prior to commencement. Principal investigators should not commence Category B experiments until advised by the IBC. Principal Investigators intending to conduct experiments classified as Category B should submit a ‘Proposal Form for Assessment of Genetic Manipulation Work’ to their respective IBCs for assessment. The IBC shall assess the proposal and determine the appropriate working and containment measures and facilities necessary. Page 8
Page 1 and 2: THE SINGAPORE BIOSAFETY GUIDELINES
Page 3 and 4: APPENDICES Appendix 1 Other Relevan
Page 5 and 6: 1.4 DEFINITIONS OF ABBREVIATIONS Fo
Page 7 and 8: 2.2 EXEMPTIONS 2.2.1 The following
Page 9: SECTION 3: SUMMARY OF PROCEDURES 3.
Page 13 and 14: SECTION 4: EXPERIMENTS COVERED BY T
Page 15 and 16: 4.2 CATEGORY B - EXPERIMENTS REQUIR
Page 17 and 18: SECTION 5: ROLES AND RESPONSIBILITI
Page 19 and 20: 5.2.5 Monitoring of Work The IBC sh
Page 21 and 22: • submit a new proposal form to t
Page 23 and 24: • All materials that are genetica
Page 25 and 26: 6.5 SUPPLY OF GENETICALLY MANIPULAT
Page 27 and 28: 6.6.5 The form should contain any r
Page 29 and 30: BLANK PAGE
Page 31 and 32: 3. Worldwide guidelines specific to
Page 33 and 34: xiv. AS 2252.2: 1994: xv. AS 2647:
Page 35 and 36: APPENDIX 2: LIST OF GMAC-APPROVED H
Page 37 and 38: APPENDIX 3: INSTRUCTIONS FOR COMPLE
Page 39 and 40: PROPOSAL FORM FOR ASSESSMENT OF GEN
Page 41 and 42: -----------------------------------
Page 43 and 44: ) Describe the techniques to be emp
Page 45 and 46: ii) Category B iii) Category C C. R
Page 47 and 48: APPENDIX 4: TOXINS For work involvi
Page 49 and 50: 4. Procedures for handling viruses
Page 51 and 52: staff shall handle these infected a
Page 53 and 54: APPENDIX 7: REQUIREMENTS FOR GENETI
Page 55 and 56: equire the provision of a front cov
Page 57 and 58: Signs 10. An automatically-starting
Page 59 and 60: 9. All plants in the plant house sh
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APPENDIX 12: PROCEDURES FOR EXPERIM
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APPENDIX 13: DESIGN OF ANIMAL FACIL
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Other Work Being Performed in the S
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permitted in animal rooms. Personne
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APPENDIX 15: REQUIREMENTS FOR GENET
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APPENDIX 16: REQUIREMENTS FOR INSEC
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APPENDIX 17: REQUIREMENTS FOR INSEC
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APPENDIX 18: PROCEDURES FOR EXPERIM
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From Bio-Security Assurance Arrange
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VIRUSES (con’t) Family and genus
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PESTS (cont’d) INSECTS MAIN HOST
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PESTS (cont’d) NEMATODES MAIN HOS
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PESTS (cont’d) NEMATODES MAIN HOS
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From the Notifiable Diseases List o
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From the Notifiable Diseases List o
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APPENDIX 20: GLOSSARY Note: Words a
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fusion gamete gene gene therapy gen
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polymerase chain reaction prion pro
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