Biosafety Guidelines For Research On Genetically Modified ...

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2.2.2 All experiments, whether exempt or not, should be carried out under conditions of standard microbiological laboratory practice. When pathogenic organisms are used, appropriate containment levels should be used and the personnel should be properly trained and have had the recommended vaccinations as stipulated in the guidelines issued or recommended by regulatory authorities such as MOH and AVA, e.g. Laboratory Biosafety Manual, 3 rd Ed, World Health Organization. 2.2.3 Exemptions under Sections 2.2.1 (i) – 2.2.1 (viii) do not apply should the experiments involve intentional releases of genetically manipulated organisms, which include contained field trials. Such experiments must adhere to the Singapore Guidelines on the Release of Agriculture-related Genetically Modified Organisms. 2.2.4 Exemption from these guidelines does not equal exemption from statutory provisions applying to any aspect of a project involving genetic manipulation (e.g. importation, quarantine legislation). 2.3 REGULATORY AGENCIES The national agencies responsible for the various aspects of regulatory affairs on behalf of the GMAC are: • Regulation of laboratories dealing with GMO research, involving animal pathogens and plant pests – AVA • Importation of organisms including GMOs – AVA, MOH and NEA (please also see section 6) • Certification of Safety and Health of workers – MOM • Research Laboratory Certification - MOM • Clinical Laboratory Certification - MOH Page 5
SECTION 3: SUMMARY OF PROCEDURES 3.1 DECISION FLOW CHART FOR ASSESSMENT AND NOTIFICATION OF RESEARCH WORK The relevant procedures for assessment and notification of research work involving genetic manipulation are detailed in Sections 3.3 – 3.6. A simplified Decision Chart is shown below for easy referral. Does the work fall within the extent of the GMAC Guidelines (see Section 2.1) Yes No Don’t know No action required Consult IBC for advice Is the work exempt from the Guidelines under Sections 2.2.1 (i.e Category C) No Yes No action required Don’t know Consult IBC for advice Principal Investigator (PI) 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 IBC Assess the proposal IBC Approval Category A IBC Notify GMAC of decision. Forward a copy of duly-signed proposal form and relevant documents to GMAC. GMAC Review proposal and forward comments/recommendations to IBC and (if necessary) to regulatory authorities. PI DO NOT commence work UNTIL IBC approval AND GMAC acknowledgement of notification is received. Category B IBC Inform GMAC of decision. Forward a copy of duly-signed proposal form and relevant documents. GMAC GMAC will normally not advise IBC on Category B proposals. PI DO NOT commence work UNTIL IBC gives approval. Page 6
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: 2.2 EXEMPTIONS 2.2.1 The following
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
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
Page 61 and 62:
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
Page 69 and 70:
APPENDIX 15: REQUIREMENTS FOR GENET
Page 71 and 72:
APPENDIX 16: REQUIREMENTS FOR INSEC
Page 73 and 74:
APPENDIX 17: REQUIREMENTS FOR INSEC
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APPENDIX 18: PROCEDURES FOR EXPERIM
Page 77 and 78:
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
Page 93 and 94:
fusion gamete gene gene therapy gen
Page 95 and 96:
polymerase chain reaction prion pro
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