Biosafety Guidelines For Research On Genetically Modified ...

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TABLE OF CONTENTS Section 1: INTRODUCTION 1.1 Background 1 1.2 Objectives of Guidelines 1 1.3 Scope of Guidelines 1 1.4 Definitions of Abbreviations 2 Section 2: PURVIEW – EXTENT AND EXEMPTIONS 2.1 Extent of Guidelines 3 2.2 Exemptions 4 2.3 Regulatory Agencies 5 Section 3: SUMMARY OF PROCEDURES 3.1 Decision Flow Chart for Assessment and Notification of Research Work 6 3.2 Flow Chart for Importation of GMOs for Research 7 3.3 Category A – Experiments requiring IBC Approval and GMAC Notification (Regulated Experiments with Significant Risks) 8 3.4 Category B – Experiments requiring IBC Approval (Notifiable Experiments with Low Risks) 8 3.5 Category C – Experiments Exempt From the Guidelines (Experiments with No Significant Risks) 9 Section 4: EXPERIMENTS COVERED BY THE GUIDELINES 4.1 Category A – Experiments requiring IBC Approval and GMAC Notification (Regulated Experiments with Significant Risks) 10 4.2 Category B – Experiments requiring IBC Approval (Notifiable Experiments with Low Risks) 12 4.3 Category C – Experiments Exempt From the Guidelines (Experiments with No Significant Risks) 13 Section 5: ROLES AND RESPONSIBILITIES 5.1 Institutions 14 5.2 Institutional Biosafety Committees 15 5.3 Principal Investigators 17 Section 6: TRANSPORT AND IMPORT 6.1 General Consideration for Transport and Packaging 19 6.2 Transport of Transgenic Animals 20 6.3 Transport of Transgenic Insects and their Pathogens 21 6.4 Transport of transgenic plants 21 6.5 Supply of Genetically Manipulated Material to Other Research Workers 22 6.6 Import of Genetically Manipulated Organisms or Materials 23
APPENDICES Appendix 1 Other Relevant Documents Appendix 2 List of GMAC-Approved Host/Vector Systems Appendix 3 Instructions for Completing GMAC Proposal Forms and Annual Reports by IBC Appendix 4 Toxins Appendix 5 Guidance for Work Involving GM Viruses for Gene Transfer into Animal & Human Cells in a Laboratory Setting Appendix 6 Procedures for Work with Hazardous Fragments of DNA Appendix 7 Requirements for Genetic Modification Biosafety Level 2 (GM-BSL2) Appendix 8 Requirements for Genetic Modification Biosafety Level 3 (GM-BSL3) Appendix 9 Requirements for Genetic Modification Biosafety Level 4 (GM-BSL4) Appendix 10 Requirements for Plant House Biosafety Level 2 (GP-BSL2) Appendix 11 Requirements for Plant House Biosafety Level 3 (GP-BSL3) Appendix 12 Procedures for Experiments Involving Transgenic Animals Appendix 13 Design of Animal Facilities Appendix 14 Requirements for Genetic Modification Animal Biosafety Level 2 (GA-BSL2) Appendix 15 Requirements for Genetic Modification Animal Biosafety Level 3 (GA-BSL3) Appendix 16 Requirements for Insectary Biosafety Level 2 (GI-BSL2) Appendix 17 Requirements for Insectary Biosafety Level 3 (GI-BSL3) Appendix 18 Procedures for Experiments Involving Fish and Other Aquatic Organisms Appendix 19 Regulated Organisms Appendix 20 Glossary
Page 1: THE SINGAPORE BIOSAFETY GUIDELINES
Page 5 and 6: 1.4 DEFINITIONS OF ABBREVIATIONS Fo
Page 7 and 8: 2.2 EXEMPTIONS 2.2.1 The following
Page 9 and 10: SECTION 3: SUMMARY OF PROCEDURES 3.
Page 11 and 12: 3.3 CATEGORY A - EXPERIMENTS REQUIR
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
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equire the provision of a front cov
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Signs 10. An automatically-starting
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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
Page 81 and 82:
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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